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PHYSICIAN REFERENCE MANUALApril 2010

Physician Reference Manual

This information has been developed as a guideline for the Zenith Low Profile (LP) AAA Endovascular Graft. Information may vary according to individual patient condition or physician preference. These instructions are intended to help guide the physician and do not take the place of physician judgment.

Ch

apter Contents1 IntRoduCtIon

Introduction

Abdominal Aortic Aneurysms

History & Development

Rationale for Using an Endovascular Graft

Intended Use

Zenith LP AAA Endovascular Graft System Design

2 devICe desCRIPtIons

Introduction

Design Characteristics: Zenith LP AAA Endovascular Graft

Features of the Zenith LP AAA Endovascular Graft

Design Characteristics: H&L-B One-Shot™ Introduction System

Features of the H&L-B One-Shot™ Introduction System

3 AnCIllARy CoMPonents

Introduction

Converter

Iliac Leg Extension

Iliac Plug

Main Body Extension

4 PAtIent seleCtIon

5 PlAnnIng & sIzIng

6 dePloyMent

Bifurcated System

Ancillary Devices

7 FACIlItIes & suPPleMentAl equIPMent

Facilities

Supplemental Equipment

8 tRoubleshootIng

Cross-Reference Table

Patient-Related

Procedure-Related

Device-Related

Endoleaks

9 Post-PRoCeduRe PAtIent CARe & Follow-uP

Transcend: PrecisionRealize low-profile delivery with precision.

CHAPTER 1Introduction

1

6

Introduction

Introduction

The following materials have been developed to assist with the training and education for the treatment of endovascular abdominal aortic aneurysm repair using the Zenith LP AAA Endovascular Graft. This reference manual provides training in the use of the Zenith LP AAA Endovascular Graft and its introduction system, including patient selection, procedure planning and device sizing, placement of the endovascular graft and post-procedure patient management.

This information is intended to help guide the physician and does not take the place of physician judgement.

Abdominal Aortic Aneurysms

Definition

An abdominal aortic aneurysm (AAA) is a dilation of the distal aorta which becomes more likely to rupture as it dilates to more than 5 cm in diameter. AAA is diagnosed in over 200,000 patients annually in the United States. Aneurysm rupture is usually fatal, leading to 13,000 deaths annually in the United States. In many instances, aneurysms are associated with other types of cardiovascular disease, especially hypertension, atherosclerosis and coronary artery disease. Traumatic injuries, infections and congenital disorders also can cause aneurysms.

Alternative AAA Repair

An alternative to open surgical AAA repair is the placement of a bifurcated endovascular graft into the aorta via the femoral arteries. The stent graft reduces pressure on the aneurysm sac while maintaining the natural proximal-to-distal blood flow by forming a new tubular conduit within the existing aorta.

Abdominal Aortic Aneurysm

7

history and development

Zenith LP AAA Endovascular Graft System

The Zenith LP (Low Profile) AAA Endovascular Graft System with the H&L-B One-Shot Introduction System is the result of a collaborative effort by Dr. Timothy A.M. Chuter (USA) and several Cook Companies (MED Institute, William Cook Australia, Cook Incorporated and William Cook Europe). The development of the LP system was initiated in late 2004, with the first implantation occurring in 2008 and a subsequent U.S. clinical trial commencing in 2009. Zenith LP first became commercially available in Europe in 2010.

The design of Zenith LP is based upon Cook Medical’s original Zenith AAA Endovascular Graft, which has been implanted in well over 100,000 patients worldwide since earning CE Mark (EU) in 1999 and FDA Approval (USA) in 2003. Zenith LP is constructed with innovative materials resulting in a lower-profile, MR-conditional device that does not compromise the key performance features (active fixation, radial force, and columnar strength) critical to the success of Zenith. In addition, precision deployment is maintained with a simplified delivery system that removes the need to dock the top cap, as a top cap is not present on the LP system.

8

Introduction

Rationale for using an endovascular graft

The Zenith LP AAA Endovascular Graft and its 16 Fr Low Profile introduction system has been developed to provide a less invasive alternative to conventional open surgical repair of abdominal aortic aneurysms. Compared to open surgical repair, endovascular graft placement produces:

• Less patient discomfort

• Shorter hospitalization/recovery time

• Fewer procedure-related risks

• Less blood loss

• Less effect on cardiovascular, respiratory, gastrointestinal, and renal function.

Intended use

The Zenith Low Profile AAA Endovascular Graft and ancillary components are indicated for the endovascular treatment of patients with abdominal aortic or aorto-iliac aneurysms having morphology suitable for endovascular repair, including:

• Iliac/femoral anatomy that is suitable for access with a 16 French (6.0 mm OD) introduction system;

• Non-aneurysmal infrarenal aortic segment (neck) proximal to the aneurysm:

- with a length of at least 15 mm;

- with a diameter measured outer wall to outer wall of no greater than 28 mm and no less than 18 mm;

- with an angle < 60° relative to the long axis of the aneurysm; and

- with an angle < 45° relative to the axis of the suprarenal aorta.

• Iliac artery distal fixation site greater than 10 mm in length and 8 to 20 mm in diameter (measured outer wall to outer wall).

9

zenith low Profile AAA endovasculargraft system design

The Zenith LP AAA Endovascular Graft with the H&L-B One-Shot Introduction System is a modular system consisting of three components, a bifurcated aortic main body and two iliac legs. The graft modules are constructed of woven polyester fabric sewn to self-expanding nitinol stents with braided polyester and monofilament polypropylene suture. The main body system has one long iliac (ipsilateral) limb and one short iliac (contralateral) limb, which provide a means to attach the extension legs. The contralateral and ipsilateral iliac legs are introduced via their respective H&L-B One-Shot

Introduction Systems. Both iliac legs are docked into the main body to form two adjacent channels.

Zenith LP AAA Endovascular Graft

CHAPTER 2Device Descriptions

2

12

Device Descriptions

Introduction

The Zenith LP AAA Endovascular Graft is available as a bifurcated system for endovascular repair of infrarenal abdominal aortic aneurysms (AAA). The endovascular graft is self-expanding, fully supported, modular and features a proximal suprarenal attachment stent. The device is mounted and pre-loaded in the H&L-B One-Shot Introduction System. Extension legs of various lengths and diameters may be coupled with the main body of the bifurcated device, providing a variety of overall device lengths.

Ancillary components are also available for Zenith Low Profile AAA implant procedures. These ancillary components include aortic main body extensions, converters and Iliac plugs. The various ancillary components can be used to correct inaccuracies in device size selection or to compensate for difficult anatomy encountered during the implant procedure.

note: The Zenith Iliac Plug is only available in 18 and 20 French delivery systems.

Ancillary Components-Main Body Extension, Converter & Iliac Plug


13

design Characteristics


The Zenith LP AAA Endovascular Graft is a bifurcated, modular system consisting of self-expanding nitinol stents and woven polyester graft material. The endovascular graft is a three-component device (an aortic main body and two iliac legs), the sizes of which can be selected to match a variety of patient anatomies and specific treatment goals. The endovascular components are manufactured in various standard stock sizes, supplied sterile, pre-loaded in their respective delivery systems, and ready for use with minimal pre-deployment preparation.

Zenith LP AAA Bifurcated Main Bodies

H&L-B One-Shot Introduction System

Ipsilateral Limb (il)* - 94 mm

Contralateral Limb (cl)† - 70 mm











16 Fr System16 Fr (5.3 mm) ID

6.0 mm OD

ZALB-22-70 ZALB-24-70 ZALB-26-70 ZALB-28-70 ZALB-30-70 ZALB-32-70






catalog number indicates main body diameter (mm) and contralateral limb length (mm) *il = main body length on ipsilateral side†cl = main body length on contralateral side

Sheath length for all diameters = 43 cm Sheath and valve length for all diameters = 52 cm

14

Device Descriptions

The main body of the graft is comprised of an aortic section, one short iliac limb (contralateral limb) and one long iliac limb (ipsilateral limb). The main body is introduced via the common femoral artery. An iliac leg is delivered via the contralateral common femoral artery and is docked with the short limb of the main body to form a continuous channel into the contralateral iliac artery. A second iliac leg is delivered via the ipsilateral iliac artery and is docked with the long limb of the main body to form a continuous channel into the ipsilateral iliac artery.

The main graft component consists of woven polyester fabric and is fully stented with self-expanding nitinol stents. These stents provide stability and the expansile force necessary to open the lumen of the graft during deployment. Additionally, they assist with securing and sealing the graft to the vessel wall. The stents are located on the inside of the graft at the vessel seal sites and portions of the overlap joints and on the outside of the remainder of the graft to provide a smooth inner lumen. A suprarenal uncovered stent aids in fixation.

Features of the zenith low Profile AAAendovascular graft

The following section illustrates the features of the Zenith Low Profile AAA Endovascular Graft.

Modular Design

Three-piece modular system allows the physician to customize a graft system to each patient’s individual anatomy.

15

Suprarenal Fixation

Secures graft to suprarenal aortic wall, reducing the risk of migration and enhancing graft/vessel seal.

Dual level barb positioning on suprarenal stents varies the level of attachment to the aorta.

Proximal Design

Optimized gap length incorporated onto the proximal segment of the main body provides conformance to angulated anatomy.

Woven Polyester

A lightweight, strong, shrink/stretch resistant synthetic polymer is used in both plastics and fibers.

This material is also used for open surgical AAA procedures.

Unique Stent Graft Design

Independent stent configuration provides graft flexibility.

Stent graft construction allows for unique adaptability to individual anatomy.

Varied stent lengths and gage diameters promote secure graft/vessel apposition, columnar strength and graft flexibility.

16

Device Descriptions

Proximal Gold Radiopaque Markers

Four gold markers (2 mm from the most proximal segment of the graft material) identify the most proximal segment of the graft material.

Contralateral Limb Gold Radiopaque Marker

Gold "check mark" ( ) identifies proper contralateral limborientation, simplifying contralateral limb wire guide access.

17

Low Iliac Attachment

Extended main body with low iliac graft bifurcation provides longitudinal/columnar strength and simplifies cannulation of the contralateral limb.

Iliac Legs

Both the ipsilateral and the contralateral iliac legs are docked into the main body of the bifurcated graft to form two adjacent channels. A gold marker is positioned 36 mm from the proximal edge to indicate optimal overlap with main body ipsilateral and contralateral sides.

H&L-B One-ShotIntroduction System

Zenith Low Profile AAA Iliac Legs

14 Fr System14 Fr (4.7 mm) ID

5.3 mm OD

ZALL-10-36 ZALL-10-48 ZALL-10-60 ZALL-10-72 ZALL-10-84 ZALL-10-96

ZALL-10-108 ZALL-10-120


ZALL-12-108 ZALL-12-120


ZALL-14-108






Catalog number indicates distal diameter (mm) and working length (mm).

Sheath length for all diameters = 71 cm

Sheath & Valve length for all diameters = 80 cm

18

Device Descriptions

Design Characteristics


The H&L-B One-Shot Introduction System was designed for ease of use with minimal preparation. Its design was developed in accordance with performance requirements from physicians, radiographers, engineers and technicians. Its simple, sequential deployment method provides continuous control of the entire graft system throughout the procedure. The H&L-B One-Shot Introduction System enables precise positioning and the ability to readjust the graft before deploying the suprarenal stent.


19

Features of the h&l-b one-shot Introduction system

the following features highlight additional attributes of the h&l-b one-shot Introduction system.

Dilator Tip

Long, tapered tip minimizes vessel trauma and offers excellent trackability.

Proximal (Suprarenal) Trigger-Wire Attachment

The proximal uncovered z-stent is a top-capless design and is secured with multiple trigger-wires working in unison. note: Graft diameters 22-26 mm have 4 proximal trigger-wires. Graft diameters 28-32 mm have 5 proximal trigger-wires.

These trigger-wires facilitate:

1. Stabilization of the endovascular graft during deployment.

2. Controlled release of the graft from the delivery system.

3. Graft manipulation in a semi-deployed position.

20

Device Descriptions

Trigger-Wire Release Mechanisms

The top stent (proximal) and ipsilateral limb (distal) release knobs are attached to their respective trigger-wires and are used when the device is ready to be released from the delivery system. Sequential release knob positioning simplifies the deployment process.

Grey Positioner

The ipsilateral limb is attached to the proximal tip of the grey positioner and can only be released after the ipsilateral limb has been unsheathed (opened) and the distal (ipsilateral limb) trigger-wire release mechanism has been removed.

Nitinol Inner Cannula

Inner cannula provides over-the-wire trackability.

21

Low Profile Introducer Sheath

The bifurcated grafts are pre-loaded into 16 Fr introducer sheaths.

Iliac legs are pre-loaded into 14 Fr introducer sheaths.

Captor® Hemostatic Valve

The Captor Hemostatic Valve is incorporated into all main body and iliac leg delivery systems.

Unique design inhibits blood reflux.

Flexor® Introducer Sheath

Unique sheath construction provides optimal flexibility and maximum resistance to kinking or compression.

Radiopaque tip incorporated within sheath material identifies precise location of sheath’s distal tip for positioning accuracy.

CHAPTER 3Ancillary Components

3

24

Ancillary Components

Introduction

Ancillary components are also available for Zenith Low Profile AAA implant procedures. These ancillary components include aortic main body extensions, converters, and iliac plugs. The various ancillary components can be used to correct inaccuracies in device size selection or to compensate for difficult anatomy encountered during the implant procedure.

Refer to the deployment section of the Physician Reference Manual or the Instructions for Use booklet for complete deployment instructions for the converter and main body extension stent grafts.


Ancillary Components-Main Body Extension, Converter & Iliac Plug

25

Converter

The converter is used to convert a bifurcated graft to an aortouni-iliac graft. The converter is comprised of five nitinol stents.

Converters utilize 16 French H&L-B One-Shot Introduction Systems. The converter introduction system contains a single trigger-wire release mechanism. Deployment of the converter is achieved by sheath retraction and removing the distal trigger-wire.

The converter has a single gold radiopaque marker positioned within 2 mm of the most superior aspect of the graft material. For added hemostasis, the Captor Hemostatic Valve can be loosened or tightened for the introduction and/or removal of ancillary devices into and out of the sheath. The converter delivery system features a Flexor introducer sheath, which resists kinking and is hydrophilically coated. Both features are intended to enhance trackability in the iliac arteries and abdominal aorta.

note: The H&L-B One-Shot Introduction System for the converter incorporates a single trigger-wire release mechanism.

note: The trigger-wire should not be released and removed until converter has been deployed from the sheath.

note: Converter introducer sheaths are inserted over-the-wire and should never be introduced through the sheath of a main body or an iliac leg introducer sheath.

OrderNumber

ProximalDiameter

mm

DistalDiameter

mmLength

mmIntroducer

Sheath ID/OD

SheathLength

cm

ZLC-24-66 24 12 66 16 Fr (5.3 mm)/6.0 mm 43

ZLC-28-66 28 12 66 16 Fr (5.3 mm)/6.0mm 43

ZLC-32-66 32 12 66 16 Fr (5.3 mm)/6.0 mm 43

Converter

Dilator Tip

Stopcock

Connecting Tube

Introducer Sheath

Sheath Sideport

Converter

Hemostatic Valve

Grey Positioner

Inner Cannula Black Trigger-

wire Release Mechanism

Peel-Away Sheath

Hub Pin Vise

Safety Lock

26


Iliac Plug

The iliac plug is used for the occlusion of an iliac artery when an aortouni-iliac and/or femoral-to-femoral crossover procedure is performed. For more information on this component, please refer to the Zenith AAA Endovascular Graft Ancillary Components Suggested Instructions for Use found on the Cook Medical website at www.cookmedical.com.


Iliac Plug

27

Main body extension

The main body extension is used to lengthen the proximal end of an in situ endovascular graft. Main body extensions are available as either a two-stent or three-stent component.

Main body extensions utilize 16 French H&L-B One-Shot Introduction Systems. The main body extension introduction system contains a single trigger-wire release mechanism. Deployment of the main body extension is achieved by sheath retraction and removing the distal trigger-wire.

To facilitate fluoroscopic visualization of the stent grafts, the main body extensions have 4 gold radiopaque markers positioned in a circumferential orientation within 2 mm of the most superior aspect of the graft material. For added hemostasis, the Captor Hemostatic Valve can be loosened or tightened for the introduction and/or removal of ancillary devices into and out of the sheath. The main body extension delivery systems feature a Flexor introducer sheath which resists kinking and is hydrophilically coated. Both features are intended to enchance trackability in the iliac arteries and abdominal aorta.

note: The H&L-B One-Shot Introduction System for the main body extension incorporates a single trigger-wire release mechanism.

note: The trigger-wire should not be released and removed until the main body extension has been deployed from the sheath.

note: Main body extension introduction systems are inserted over-the-wire and should never be introduced through the sheath of a main body or an iliac leg introducer sheath.

2-Stent Main Body Extension

OrderNumber

Diametermm

Lengthmm

Introducer Sheath ID/OD

SheathLength

cm

ZLBE-22-45 22 45 16 Fr (5.3 mm)/6.0 mm 43

ZLBE-24-45 24 45 16 Fr (5.3 mm)/6.0 mm 43

ZLBE-26-45 26 45 16 Fr (5.3 mm)/6.0 mm 43

ZLBE-28-45 28 45 16 Fr (5.3 mm)/6.0 mm 43

ZLBE-30-45 30 45 16 Fr (5.3 mm)/6.0 mm 43

ZLBE-32-45 32 45 16 Fr (5.3 mm)/6.0 mm 43

3-Stent Main Body Extension

OrderNumber

Diametermm

Lengthmm

Introducer Sheath ID/OD

SheathLength

cm

ZLBE-22-58 22 58 16 Fr (5.3 mm)/6.0 mm 43

ZLBE-24-58 24 58 16 Fr (5.3 mm)/6.0 mm 43

ZLBE-26-58 26 58 16 Fr (5.3 mm)/6.0 mm 43

ZLBE-28-58 28 58 16 Fr (5.3 mm)/6.0 mm 43

ZLBE-30-58 30 58 16 Fr (5.3 mm)/6.0 mm 43

ZLBE-32-58 32 58 16 Fr (5.3 mm)/6.0 mm 43

Main Body Extensions

58 mm

CHAPTER 4Patient Selection

4

30

Patient Selection

Patient selection

Patient selection is very important. Patients must meet the indications for use and other criteria to be candidates for the Zenith Low Profile AAA Endovascular Graft.

Objectives

The objective of patient selection is to determine:

1. If the patient is a candidate for AAA repair;

2. If the patient is a candidate for endovascular therapy; and

3. If the patient is a candidate for implantation of the Zenith

Low Profile AAA Endovascular Graft.

The process of patient selection should include, but not be limited to:

• Patient history and physical examination.

• High quality contrast and non-contrast CT of the abdominal aortic aneurysm from 1 cm above the celiac axis to the profunda femoris. (table 5.1 in Planning and Sizing Chapter)

• Angiographic imaging with AP and lateral views from celiac axis to profunda femoris with contrast and a calibrated catheter with radiopaque marker bands.

• Evaluation of factors predictive of rupture such as aneurysm size and rate of growth.

• Evaluation of the risk of AAA surgical treatment based upon demographic factors, patient history and co-morbidities.

• Evaluation of the risks of endovascular treatment based upon anatomical criteria.

• Evaluation of the patient’s ability to comply with required follow-up.

• Patient counseling and determination of the most appropriate treatment strategy for each patient based upon the relative risks and benefits of available treatment strategies.

31

Indications for use for the zenith low Profile AAA endovascular graft

The Zenith Low Profile AAA Endovascular Graft and ancillary components is indicated for the endovascular treatment of patients with abdominal aortic or aorto-iliac aneurysms having morphology suitable for endovascular repair, including:

• Iliac/femoral anatomy that is suitable for access with a 16 French (6.0 mm OD) introduction system;

• Non-aneurysmal infrarenal aortic segment (neck) proximal to the aneurysm

- with a length of at least 15 mm;

- with a diameter measured outer wall to outer wall of no greater than 28 mm and no less than 18 mm;

- with an angle < 60° relative to the long axis of the aneurysm; and

- with an angle < 45° relative to the axis of the suprarenal aorta.

• Iliac artery distal fixation site greater than 10 mm in length and 8 to 20 mm in diameter (measured outer wall to outer wall).

Contraindications

The Zenith Low Profile AAA Endovascular Graft with the H&L-B One-Shot Introduction System is contraindicated in:

• Patients with known sensitivities or allergies to nitinol, polyester, polypropylene, or gold.

• Patients with a systemic infection who may be at increased risk of endovascular graft infection.

Preoperative Assessment

Patient evaluation and endovascular graft planning are critical to successful endovascular aneurysm repair. Before choosing treatment with an endovascular graft, all patients should be assessed preoperatively to determine the patient’s risk factors associated with treatment. Preoperative assessment provides the basis for evaluating various treatment options and for counseling the patient about potential complications. Anatomical considerations establish patient suitability for endovascular repair and are specific to device design.

32

Patient Selection

General Patient History and Physical Exam

The preoperative assessment for patients requiring treatment should include an evaluation of the aneurysm’s risk for rupture, relative to the risks of aneurysm repair. The relative merits of endovascular repair must be compared with conventional treatments. The history and physical exam should allow assessment of the following:

• Hypertension

• COPD

• Life expectancy based on co-morbid factors

• Pulmonary function

• History of diabetes

• Hepatic function

• Renal function

- care should be taken to limit the amount of contrast media used during the procedure. Patients with preexisting renal insufficiency may have an increased risk of postoperative renal failure.

• History of cerebrovascular accident

• Hostile abdomen

• Patient’s cardiac function and history (myocardial infarction, angina pectoris, severe coronary artery disease, irregular thallium persantine test, increased diastolic or systolic blood pressure)

• Genetic disease

• Coagulopathy

• Allergies

- The Zenith Low Profile AAA Endovascular Graft is not recommended in patients who cannot tolerate contrast agents necessary for peri-operative and postoperative follow-up imaging.

- The Zenith Low Profile AAA Endovascular Graft is not recommended in patients with known sensitivities or allergies to nitinol, polyester, polypropylene or gold.

• Obesity

- The Zenith Low Profile AAA Endovascular Graft is not recommended in patients exceeding weight and/or size limits which compromise or prevent the necessary imaging requirements.

33

MRI Safety and Compatibility

Non-clinical testing has demonstrated that the Zenith Low Profile AAA Endovascular Graft is MR Conditional. It can be scanned safely under the following conditions:

1.5 Tesla Systems:

• Static magnetic field of 1.5 Tesla

• Spatial gradient field of 450 Gauss/cm or less

• Maximum whole-body-averaged specific absorption rate (SAR) of 2.0 W/kg (normal operating mode) for 15 minutes of scanning.

In non-clinical testing, the Zenith Low Profile AAA Endovascular Graft produced a temperature rise of less than 1.7 °C at a maximum whole-body-averaged specific absorption rate (SAR) of 2.9 W/kg on the MR console display for 15 minutes of MR scanning in a 1.5 Tesla Magnetom, Siemens Medical Magnetom MR scanner. The maximum whole-body-averaged specific absorption rate (SAR) was 2.9 W/kg, which corresponds to a calorimetry measured value of 2.1 W/kg.

3.0 Tesla Systems:



• Maximum whole-body-averaged specific absorption rate (SAR) of 2.0 W/kg (normal operating mode) for 15 minutes of scanning

In non-clinical testing, the Zenith Low Profile AAA Endovascular Graft produced a temperature rise of less than 2.0 °C at a maximum whole-body-averaged specific absorption rate (SAR) of 3.0 W/kg on the MR console display for 15 minutes of MR scanning in a 3.0 Tesla, Excite, GE Healthcare MR scanner. The maximum whole-body-averaged specific absorption rate (SAR) was 3.0 W/kg, which corresponds to a calorimetry measured value of 2.8 W/kg.

MR image quality may be compromised if the area of interest is in the exact same area or within approximately 5 mm of the position of the Zenith Low Profile AAA Endovascular Graft as found during non-clinical testing using the sequence: T1-weighted, spin echo and Gradient echo pulse sequence in a 3.0 Tesla, Excite, GE Healthcare, with G3.0-052B Software, MR system with body radiofrequency coil. Therefore, it may be necessary to optimize MR imaging parameters for the presence of this metallic implant.

Cook recommends that the patient register the MR conditions disclosed in this section with the MedicAlert Foundation. The MedicAlert Foundation can be contacted in the following manners:

Mail: MedicAlert Foundation International 2323 Colorado Avenue Turlock, CA 95382

Phone: 888-633-4298 (toll free) 209-668-3333 from outside the US Fax: 209-669-2450

Web: www.medicalert.org

34

Patient Selection

Anatomical Assessment

The following anatomical factors may influence the success of endovascular grafting:

• Length, diameter, angulation and morphology of the proximal neck, including the presence of thrombus or calcification

- Aortic neck morphology is critically related to effective sealing and stability. The sealing stent at the proximal fixation site must be placed parallel to the axis of the non-dilated aorta. Thus, in extremely tortuous aortas, endovascular repair should be avoided (Stanley et al, 20011; Greenberg, 20022).

- Key anatomic elements that may affect successful exclusion of the aneurysm include (Fig. 4.1):

• severe proximal neck angulation (≥ 60° for infrarenal neck to axis of AAA; or

• ≥ 45° for suprarenal neck relative to the immediate infrarenal neck);

• short proximal aortic neck (< 15 mm);

• an inverted funnel shape (> 10% increase in diameter over 15 mm of proximal aortic neck length); and

• circumferential thrombus and/or calcification at the arterial fixation sites, specifically the proximal aortic neck and distal iliac artery fixation site.

- A long neck affords better sealing and greater stability (Stanley et al, 2001; Greenberg, 2002). Proximal aortic necks with a length < 15 mm may be more conducive to endoleak and graft migration and may complicate device delivery. The proximal aortic neck should be a minimum of 15 mm in length around the entire circumference.

- Proximal aortic necks > 28 mm in diameter may be more conducive to endoleak.

- Immediate suprarenal neck angulation ≥ 45° relative to the immediate infrarenal neck may be more conducive to endoleak(s).

- Aortic neck angulation ≥ 60° (infrarenal neck to axis of AAA) may be more conducive to endoleak(s) and may complicate device delivery.

- Nonparallel neck shapes like an hourglass, bulging or inverted funnel aortic necks (i.e., aortic necks with > 10% increase in diameter over 15 mm of proximal aortic neck length) may be more conducive to graft migration.

- Irregular calcification, plaque and/or thrombus may compromise the fixation and sealing of the implantation sites. Necks exhibiting these key anatomic elements may be more conducive to graft migration.

Fig. 4.1Suitable Morphology

< 45°

< 60°

18-25 mm

≤ 20 mm

> 10 mm, preferably 20 mm or longer

> 10 mm, preferably 20 mm or longer

≥ 15 mm

≥ 8 mm

35

• Diameter and morphology of iliac arteries (tortuosity, severe circumferential calcification or angle between the longitudinal axis of the aneurysm and each common iliac artery)

- Vessel diameter (measured inner wall to inner wall) and morphology (minimal tortuosity, occlusive disease, and/or calcification) should be compatible with vascular access techniques and delivery systems of the profile of a 14 Fr to 16 Fr vascular introducer sheath. Vessels that are significantly calcified, occlusive, tortuous or thrombus-lined may preclude placement of the endovascular graft and/or may increase the risk of embolization. Common iliac artery diameters > 20 mm at expected graft/vessel distal fixation site(s) may be prone to endoleak or continued expansion and are not indicated.

• Aneurysmal dilation of the iliac arteries

- Dilation of the iliac sealing site may result in a Type I endoleak and AAA rupture

• Location of the internal iliac arteries

- Inability to maintain patency of at least one internal iliac artery or occlusion of an indispensable inferior mesenteric artery may increase the risk of pelvic/bowel ischemia.

• Involvement of major vessels in the aneurysm sac

- Multiple large, patent lumbar arteries, mural thrombus and a patent inferior mesenteric artery may all predispose a patient to Type II endoleaks. Patients with uncorrectable coagulopathy may have an increased risk of Type II endoleak or bleeding complications.

36

Patient Selection

examples of Anatomical exclusion

Reject for Short Neck

Fig. 4.2

■ Lowest renal artery at table position 213

■ Aneurysm involvement starts by table position 223

■ 15 mm below lowest renal artery shows significant aneurysm involvement (table position 228)

■ Length of proximal neck is 10 mm (not ≥15 mm)

Avoid proximal neck length < 15 mm

37

Reject for Large Neck

Fig. 4.3Case 1

■ Case 1: Proximal neck diameter measures 34 mm on CT, failing criteria of ≤ 28 mm (Fig. 4.3)

Fig. 4.4Case 2

■ Case 2: Proximal neck diameter measures 33 mm on CT, failing criteria of ≤ 28 mm (Fig. 4.4)

Avoid proximal neck diameters > 28 mm. Diameters > 28 mm may be more prone to endoleak and graft migration.

Table position 155

Table position 247.2

34 mm

33 mm

38

Patient Selection

Reject for Neck Angulation

Fig. 4.5

■ > 60° angle (75°) between the neck and the aneurysm

Avoid immediate suprarenal neck angulation ≥ 45° relative to the immediate infrarenal neck and infrarenal neck angulation ≥ 60° to the long axis of the aneurysm. severe angulation may be more prone to endoleak(s) and may complicate device delivery.

Reject for Conical Neck

Fig. 4.6

■ Lowest renal artery at table position 192: 21 mm diameter

■ 15 mm below lowest renal artery at table position 207: 29 mm diameter

Avoid neck diameter increase >10%



Lowest renal (right) is at table position 415.50

75°

Table position 192

Table position 207

21 mm

29 mm

39

Reject for Thrombus

Fig. 4.7 Case 1

■ Case 1: Circumferential thrombus and calcification in the proximal neck (Fig. 4.7)

Fig. 4.8 Case 2

■ Case 2: Circumferential thrombus in the proximal neck (Fig. 4.8)

Reject for Iliac Diameter Too Small

Fig. 4.9

■ Iliac diameters inner wall to inner wall measure 4 mm and 5 mm; external iliac diameter ≤ 6.0 mm

External iliac diameters (inner wall to inner wall)

calibration catheter (10 mm)

4 mm 5 m

m

5 mm4 m

m

40

Patient Selection

Reject for Calcified Iliac Arteries

Fig. 4.10

■ Calcification of iliacs shown below aortic bifurcation and continuing through common iliacs and external iliacs

41

Reject for Iliac Distal Fixation Site Too Short

Fig. 4.11

■ The left common iliac is very short

■ The right common iliac is a poor implantation site with an aneurysm in its midsection

Reject for Iliac Aneurysm

Fig. 4.12

■ Bilateral iliac aneurysms






42

Patient Selection

Evaluation of Risks Not Evaluated in the Clinical Study

The safety and effectiveness of the Zenith Low Profile AAA Endovascular Graft have not been evaluated in the following patient populations:

• Traumatic aortic injury

• Leaking, ruptured or symptomatic aneurysms

• Mycotic aneurysms

• Pseudoaneurysms resulting from previous graft placement

• Revision of previously placed stent grafts

• Uncorrectable coagulopathy

- Patients with uncorrectable coagulopathy may have an increased risk of bleeding complications or Type II endoleak.

• Indispensable mesenteric artery

- Inability to maintain patency of at least one internal iliac artery or occlusion of an indispensable inferior mesenteric artery may increase the risk of pelvic/bowel ischemia.

• Genetic connective tissue disease (e.g., Marfan or Ehlers-Danlos Syndromes)

• Concomitant thoracic aortic or thoracoabdominal aneurysms

• Patients with active systemic infections

- Patients with a systemic infection may be at increased risk of endovascular graft infection.

• Pregnant or nursing females

• Morbidly obese patients

- The Zenith Low Profile AAA Endovascular Graft is not recommended in patients exceeding weight and/or size limits which compromise or prevent the necessary imaging requirements.

• Less than 18 years of age

• Patients with an aortic neck < 15 mm in length or ≥ 60° angulation of the proximal aortic neck relative to the long axis of the aneurysm

43

Patient’s Ability to Comply with Recommended Clinical and Imaging Follow-up

The patient’s willingness and ability to comply with recommended follow-up should be considered in the decision for endovascular therapy, because:

• The patient’s compliance with recommended clinical and imaging follow-up is important to safe and effective use of endovascular grafts

• All patients should be monitored closely and undergo periodic clinical and imaging follow-up to assess aneurysm exclusion, aneurysm size, patency of vessels in the treatment area, and device integrity

• Patients whose images show perigraft flow, increase in aneurysm size, occlusion of vessels in the treatment area, or potential device integrity issues should undergo imaging studies more frequently

• Patients experiencing an increase in aneurysm size should be assessed for further therapy

• Prompt treatment of perigraft flow (Type I and Type III endoleaks) is recommended

• Patients experiencing reduced blood flow through the graft limb and/or leaks may require secondary interventions or surgical procedures

Consequently, patient counseling should include the importance of follow-up and patient selection should include an assessment of the patient’s ability to comply.

References

1. Stanley BM, et al. Evaluation of patient selection guidelines for endoluminal AAA repair with the Zenith Stent-Graft: the Australian experience. .J Endovasc Ther. 2001;8:457-464.

2. Greenberg RK. Abdominal aortic endografting: fixation and sealing. J Am Coll Surg. 2002;194:S79-87.

CHAPTER 5Planning & Sizing

5

46

Planning and Sizing

Planning

Prior to planning and sizing the graft components, refer to chapter on Patient Selection to determine if the patient is a suitable candidate for implantation of the Zenith Low Profile AAA Endovascular Graft. The three-piece modular system of the Zenith Low Profile AAA Endovascular Graft will accommodate a wide range of patient anatomy. Pre-procedure planning assures selection of the appropriate devices. If an endovascular graft is not appropriately sized, complications including endoleak and AAA rupture may occur. Therefore, accurate sizing of the device is critical.

The outcome of AAA repair utilizing an endovascular graft is dependent upon accurate pre-procedure measurements and knowledge of the patient’s anatomy. Good angiography and CT imaging are paramount for accurate planning. Careful evaluation of the patient’s anatomy from the distal thoracic aorta to the superficial femoral arteries should be made.

Keys to successful sizing

• Adhere to Patient Selection criteria, including medical and anatomic considerations from pre-procedure imaging (refer to Patient Selection Chapter).

• Perform the following pre-procedure imaging studies:

Ct table 5.1 for protocol

Angiography table 5.2 for protocol

Imaging technologies available for aneurysm assessment include spiral CT angiography, conventional angiography, and intravascular ultrasound (IVUS). A combination of spiral CT angiography and conventional angiography is recommended for the sizing and planning of Zenith Low Profile AAA Endovascular Grafts.

• Follow the five recommended protocol steps

1. Select the side for main body introduction and fixation sites.

2. Obtain anatomical measurements and insert into worksheet.

3. Select the main body.

4. Select the contralateral iliac leg.

5. Select the ipsilateral iliac leg.

If planning and sizing is done appropriately, a good portion of the endovascular graft procedure will be accomplished before the actual implant is performed.

47

Recommended Imaging Protocols

CT Recommendations

• Film sets should include all sequential images at lowest possible slice thickness (≤ 3 mm). Do NOT perform large slice thickness (> 3 mm) and/or omit consecutive CT images/film sets, as it prevents precise anatomical and device comparisons.

• All images should include a scale for each film/image. Images should be arranged no smaller than 20:1 images on 14" x 17" (30 cm x 40 cm) sheets if film is used.

• Both non-contrast and contrast runs are recommended, with matching or corresponding table positions.

• Non-contrast and contrast run slice thickness and interval must match.

• Do NOT change patient orientation or re-landmark patient between non-contrast and contrast runs.

Non-contrast and contrast enhanced baseline imaging are important for optimal sizing and determining presence and quantity of calcium. table 5.1 lists examples of acceptable imaging protocols.

CT Non-contrast Contrast

IV contrast No Yes

Acceptable machinesSpiral CT or

high performance MDCTcapable of > 40 seconds

Spiral CT orhigh performance MDCTcapable of > 40 seconds

Injection volume n/a Per institutional protocol

Injection rate n/a > 2.5 cc/sec

Injection mode n/a Power

Bolus timing n/aTest bolus: SmartPrep, C.A.R.E.

or equivalent

Coverage – start Diaphragm 1 cm superior to celiac axis

Coverage – finish Proximal femur Profunda femoris origin

Collimation < 3 mm < 3 mm

Reconstruction2.5 mm throughout –

soft algorithm2.5 mm throughout –

soft algorithm

Axial DFOV 32 cm 32 cm

Post-injection runs None None

table 5.1Recommended CT Imaging Protocols

48

Planning and Sizing

Angiographic Recommendations

Multiview contrast-enhanced angiography of the aneurysm should be obtained. table 5.2 provides information on accepted practices.

Angiography

Catheter Calibrated catheter with radiopaque marker bands to assist in determination/verification of vessel length

Viewing AP and lateral views from celiac axis to profunda femoris with contrast*

Injection Rate Power injector at a rate per institutional protocol

Filming Per institutional protocol

*Oblique views of the internal iliac (internal iliac) arteries may be helpful.

Notes on Parallax

Parallax by definition is the apparent displacement of an object caused by a change in the observation position. (Fig. 5.1) Due to the divergent properties of the X-ray beam used in fluoroscopy, an object’s position is less reliably determined when it is further from the center of the field. Therefore, when attempting to accurately determine a particular object’s location, it is necessary to place that object in the center of the screen.

To decrease the effects of parallax:

1. Center object top to bottom.

2. Center object side to side.

3. Minimize distance between image intensifier and patient.

4. Adjust tube for angulation.

For additional information, refer to:

Broeders IA, Blankensteijn JD. A simple technique to improve the accuracy of proximal AAA endograft deployment. J Endovasc Ther. 2000;7:389-93.

table 5.2Recommended Angiography Protocol

Fig. 5.1The Effect of Parallax

Note the apparent variation in the position of the tip of the clamp relative to the radiopaque marks at the center of the field of view.

49

Planning and sizing Protocol

The Zenith Low Profile Planning and Ordering Worksheet (Page 56) has been developed to simplify the process of selecting the appropriately sized graft components. There are five main steps:

1. Select the side for main body introduction and fixation sites.

2. Obtain and insert anatomical measurements on the worksheet.

3. Select the main body.

• Select the main body diameter based on D1.

• Select the main body length (i.e., “cl” length) based on L1.

4. Select the contralateral iliac leg.

• Select the contralateral iliac leg diameter based on D2.

• Select the contralateral iliac leg length based on L2. and cl length.

5. Select the ipsilateral iliac leg.

• Select the ipsilateral iliac leg diameter based on D3.

• Select the ipsilateral iliac leg length based on L3 and il length.

steP 1: select the side for Main body Introduction and Fixation sites

Prior to choosing a Zenith Low Profile AAA Endovascular Graft system for a particular patient, the physician must make several decisions:

• Select which common femoral artery will be used to introduce the main body of the system (this choice will determine the artery that will be used to introduce the contralateral leg).

• Measure the diameter of the external Iliac (eI) artery (inside wall to inside wall) from the insertion site to the aorta. This is needed to ensure adequate access for the H&L-B One-Shot Introduction System and in choosing the side for main body introduction.

• Select the proximal fixation site.

• Select the distal fixation sites.

50

Planning and Sizing

General Guidelines for Main Body Introduction Side Selection

Patient factors to be considered when selecting main body system insertion site include:

• Iliac tortuosity/angulation

• Vessel diameter

• Aneurysmal sac orientation

• Mural thrombus within the aneurysm

• Iliofemoral disease (e.g., stenosis, calcification)

• Iliac length

As a general rule, place the main body through the side that has the best access vessel. This allows easier advancement of the main body delivery system and easier manipulation to place the contralateral limb in a position where it will be more readily cannulated. Unusual anatomy or thrombus formation may dictate that the main body delivery system needs to be placed through the less desirable access vessel, or that the limb be opened in a less than desirable position for catheterization. If one iliac is much longer than the other, choosing the longer iliac for main body introduction may be beneficial and provide more length for ipsilateral leg implantation.

A check should be made of the full length of the access vessels to be used to ensure that they are of adequate caliber and to evaluate evidence of disease. Minimum access vessel diameters should be compatible with vascular access techniques and delivery systems of a 16 French (6.0 mm) vascular introducer sheath.

note: Severe calcification or tortuosity may necessitate a larger minimum access vessel diameter.

General Guidelines for Proximal Fixation Site Selection

The top of the graft material should be positioned just below the lowest renal artery, without compromising renal artery blood flow. Clinical judgement is required in the decision to cover an accessory renal artery. Attention should be given to suprarenal and infrarenal neck angulations, as they may affect fixation and sealing of the graft. Avoid placing the sealing stent in an inverted funnel (conical) shaped neck. Likewise, avoid placing the sealing stent in a neck with a bulge or central restriction (hourglass).

51

In choosing the proximal fixation site, recognize that the proximal sealing stent will align with the axis of the proximal neck upon deployment. Ensure there is at least a 15 mm length of non-aneurysmal aorta around the entire circumference of the aorta for a good proximal seal. Consider this angulation of the graft in planning to assure that the lowest renal artery is not obstructed.

General Guidelines for Distal Fixation Site Selection

Factors that affect selection of the distal fixation sites along the iliac arteries:

• diameters of the iliac arteries

• degree of tortuosity

• degree of occlusive disease

• location of the internal iliac arteries

• iliac length >10 mm recommended (≥ 20 mm preferable)

To help secure and maintain a sufficient seal in the iliac arteries and exclude blood flow from the aneurysm, the following must be taken into consideration: patient anatomy, estimated overlap of the iliac leg with the main body, coverage of the iliac arteries to just above the origin of the internal iliac, and the avoidance of unplanned internal iliac artery occlusion.

The distal fixation site for iliac legs should preferably be 20 mm or longer. Distal fixation sites ≤ 10 mm are excluded from the indications for use. It is desirable to plan for iliac legs to extend to just above the origin of the internal iliac artery. This helps in achieving greater stability and lessens the incidence of endoleak. When an internal iliac artery is to be sacrificed and the iliac leg extended into the external iliac artery, embolization of the internal iliac artery should be performed prior to implantation. In this case the iliac leg should seal beyond the internal iliac artery bifurcation. If bilateral iliac aneurysms exist, with neither common iliac providing an acceptable distal fixation site, and the physician elects to perform an iliac transposition, this procedure should be performed prior to device implantation.

52

Planning and Sizing

Additional Considerations for Tortuous Iliac Arteries

• When the iliac arteries are tortuous, the actual distance measured around the greater curvature will be longer than that measured using axial images.

• During the implant procedure, the presence of stiff wires and/or the delivery system may cause the leg to appear too long. In this case, the overlap with the main body may be increased (i.e., tromboned) in order to avoid occluding an internal iliac artery. The allowable range of overlap for each leg length is listed in tables 5.6 and 5.8. Exceeding recommended overlap may result in occlusion at the aortic bifurcation.

• In a case of an aneurysm or severe tortuosity at the bifurcation of the internal iliac artery, an alternative fixation site proximal or distal to the tortuosity or iliac aneurysm may be considered.

steP 2: obtain Anatomical Measurements and Insert into worksheet

The Zenith Low Profile Planning and Ordering Worksheet (Page 56) has been developed to simplify the process of selecting the appropriately sized graft components. Anatomical measurements are depicted in Fig. 5.2.

Diameters by CT

Measure the following diameters (outer wall to outer wall, Fig. 5.2):

d1 Proximal aortic neck diameterLargest aortic neck diameter throughout 15 mm neck length.

note: If the origin of the lowest renal artery is visible on multiple CT slices, use the most caudal slice for measurement.

note: Check for a 10% increase in diameter from the lowest renal artery to 15 mm below the lowest renal artery. Such an increase suggests an inverted funnel (conical) neck, which is not recommended for treatment with the Zenith device.

d2 Iliac artery diameter at contralateral distal fixation siteLargest iliac diameter throughout contralateral distal fixation site.

d3 Iliac artery diameter at ipsilateral distal fixation siteLargest iliac diameter throughout ipsilateral distal fixation site.

eI external iliac artery diameter (inner wall to inner wall)From the insertion site to the aorta measured in step 1, noting the smallest diameter.

Fig. 5.2Diameter and length measurements needed for device sizing. Diameter measurements are outer wall to outer wall.

ilL3 clL1

D3D2

L2

D1

Contralateral Working Length

Ipsilateral Working Length

53

Considerations for Diameter Measurement

d1, d2, and d3 diameters are measured from outer wall to outer wall. Diameter measurements of the aortic neck and iliac vessels are best obtained from the axial CT images. In cases of proximal aortic neck angulation, preoperative use of both axial CT images and sagittal reconstructed views of the abdominal aorta are helpful in determining the proper amount of angle (caudal or cephalad) for the C-arm.

If the aorta and related vessels are tortuous, the vessels frequently will appear to be ovoid due to obliquity. Because of this appearance, measuring from outer wall to outer wall along the shortest axis most accurately estimates the aortic diameter. This is particularly important if there is debris in the lumen, since the graft is expected to expand to the vessel adventitia. Care should be taken to ensure that when making this evaluation, the ellipse or elongated shape is due to the vessel being at an angle to the CT image and not due to vessel irregularities. Assessment of the proximal aortic neck diameter and shape requires measurements of the infrarenal aorta along at least the first 15 mm of aortic neck length below the lowest renal artery.

Angiography is inappropriate for measuring diameters. IVUS may be confirmational.

Lengths by Angiography (or CT)

Measure the following lengths:

l1 Lowest renal artery to aortic bifurcation+ lateral deviation/tortuosity (Fig. 5.3a)

l2 Lowest renal artery to contralateral distal fixation site+ lateral deviation/tortuosity (Fig. 5.3b)

l3 Lowest renal artery to ipsilateral distal fixation site+ lateral deviation/tortuosity (Fig. 5.3b)

note: When using CT for length, approximate lateral deviation/tortuosity and add to difference in table position.

54

Planning and Sizing

Fig. 5.3aDetermination of L1 using calibrated catheter angiography (L1 = distance from lowest renal artery to aortic bifur-cation).

l1

Fig. 5.3bDetermination of L2 and L3 using calibrated catheter angiography (L2 = distance from lowest renal artery to contralateral fixation site and L3 = distance from lowest renal artery to ipsilateral fixation site).

l2l3

55

Considerations for Length Measurement

If both CT and angiography are available, both should be analyzed to determine the most appropriate length measurements.

Imaging information for length may be obtained from spiral CT or calibrated catheter angiography; however, angiography is preferred. With tortuous aorta and/or iliacs, assessment of length is more accurate with calibrated angiography. However, because the calibration catheter is located on only one side, the length of the iliac vessel on the opposite side will have to be approximated. Because anatomy may straighten with implantation of the graft, length should be measured to coincide with the aortic shape after implantation.

• With angiography, L1 is the expected length between the lowest renal and the aortic bifurcation along the path expected for the implanted endovascular graft, which in most cases is a straight line. (Fig. 5.3a)

• When using CT, L1 is the distance between the slice showing the lowest renal artery and the slice showing the aortic bifurcation. In the presence of tortuosity, L1 may be determined from a 3D reconstruction along the line the graft would be expected to take, keeping in mind that the presence of the graft will straighten the vessel somewhat. (Fig. 5.3a)

56

Planning and Sizing

Fig. 5.4aPlanning and Sizing Worksheet

DEVICE PLANNING AND SIZING WORKSHEET

Main BodyMain Body Graft Diameters

Ipsilateral Iliac Leg

Contralateral Iliac Leg

Date: Patient ID:

Hospital:

Physician Name:

Physician Phone #:

Physician E-mail:

Physician Signature:

Anatomical MeasurementsMain Body Introduction Site

❏ Right iliac External iliac (El) measurement _______mm

❏ Left iliac External iliac (El) measurement _______mm(Minimum diameter, inner wall to inner wall, from introduction site to aorta. Introduction system is 6.3 mm OD.)

Table Position_____ Lowest renal artery15 mm below lowest renal artery, check for 10% increase in diameter.



ilL3 clL1

D3D2

D1

L2

1 Main body length on contralateral side2 Main body length on ipsilateral side

75-92

89-102

103-112

113-122

123-132

133-142■

70

84

98

108

118

128◆

94

108

122

132

142

152◆◆

L1 cl Length1 il Length2

mm mm mm

● ●●

●●

●

■ ■■

■■

■

Diameters: D1 D2 D3

Lengths: L1 L2 L3

When using CT for length, approximate lateral deviation/tortuosity and add to difference in table position.

▲ ◆Main Body Order Number = ZALB - -

Graft Diameter

cl Length/ Graft Length

Graft Diameter

mm

22

24

26

28

30

32▲

18-19

20-21

22

23-24

25-26

27-28●

D1mm

Contralateral Leg Order Number = ZALL

▲▲- -

Graft Diameter

Graft Length

Contralateral Leg (ZALL) Graft Lengths

28-39 3640-51 4852-63 6064-75 7276-87 8488-99 96

100-111 1083

112-124 1204


mm

Graft Length

mm

★

■ ■

■

◆◆

L3 il Length

minus =


Ipsilateral Leg (ZALL) Graft Lengths

24-35 3636-47 4848-59 6060-71 7272-83 8484-95 96

96-107 1083

108-124 1204


mm

Graft Length

mm

★★2.5–4 stent overlap required.

3 Graft length 108 mm is available in 10–14 mm diameters only.4 Graft length 120 mm is available in 10 and 12 mm diameters only.

2.5–3.5 stent overlap required.

3 Graft length 108 mm is available in 10–14 mm diameters only.4 Graft length 120 mm is available in 10 and 12 mm diameters only.

Ipsilateral Leg Order Number = ZALL -

▲▲

▲

★★

Graft Diameter

Graft Length

◆

L2 cl Length

minus =


■■

★

Contralateral Leg (ZALL) Graft Diameters

8-910-1112-1314-1516-17

181920

Graft Diameter

mmD2mm

1012141618202224▲▲●●

Ipsilateral Leg (ZALL) Graft Diameters

8-910-1112-1314-1516-17

181920

●●●

Graft Diameter

mmD3mm

1012141618202224

▲▲▲

_____ Aortic bifurcation_____ Origin cl internal iliac_____ Origin il internal iliac

-

AI-BPH-LPPSW-EN-200912

0

57

Important Sizing Concepts

Before selecting components, it is important to understand two concepts: oversizing and overlap.

Component Oversizing

To help secure and maintain a sufficient seal in the aorta and exclude blood flow from the aneurysm, all component diameters should be oversized (sized greater than the measured vessel diameter, outer wall to outer wall, from CT). Graft oversizing applies to all Zenith Low Profile AAA Endovascular Graft components: main bodies, contralateral and ipsilateral iliac legs, converters and main body extensions.

Excessive graft oversizing may result in endoleak due to incomplete expansion, kinks or longitudinal folds in the graft material. Too much oversizing in small vessels could compromise lumen dimensions, too little oversizing could result in Type I endoleaks.

The choice of diameters should be determined from the outer wall to outer wall vessel diameter and not the lumen diameter. The amount of oversizing for main bodies will generally be 3-4 mm, and for iliac legs will generally be 1-2 mm. All components are available in even diameters.

58

Planning and Sizing

Iliac Leg Graft and Main Body Overlap

The length of overlap between the iliac leg and main body is nominally equivalent to three sealing stents (36 mm). However, additional overlap may increase the stability of the joint between the iliac leg and the main body so that changes in anatomy are less likely to cause limb separation. All iliac leg stents are 8 mm long. Stents are also separated by approximately 4 mm of unstented graft material. Too much overlap can result in the leg component protruding too far into the main body which may cause flow disturbances. The ranges of overlap are different for ipsilateral and contralateral legs. (Fig. 5.5) The ranges of acceptable overlap for ipsilateral and contralateral legs are listed in tables 5.6 and 5.8.

The ipsilateral limb of the main body is 24 mm longer than the contralateral limb of the main body. Therefore, the ipsilateral iliac leg may be overlapped farther into the ipsilateral limb of the main body, compared to the recommended allowable overlap for the contralateral iliac leg into the contralateral limb of the main body. (table 5.8)

Fig. 5.5Diagram of Main Body and Legs showing differing limb lengths and allowable overlap.

4 st

ents

3.5

sten

ts

3 st

ents

2.5

sten

ts

3.5

sten

ts

59

steP 3: select the Main body

One of the advantages of the design of the Zenith Low Profile AAA Endovascular Graft is that you can choose a main body that may be placed with its bifurcation close to the aortic bifurcation, providing greater stability and simplifying cannulation of the contralateral limb.

Main Body Diameter

• d1 is the largest diameter over the first 15 mm of neck length below the lowest renal artery, measured outer wall to outer wall by CT. Diameter may change over the length of the proximal aortic neck. Use the largest diameter over the first 15 mm of neck length below the lowest renal artery.

• Select a main body component with a diameter greater than the proximal aortic neck diameter (D1), generally 3-4 mm larger.

See table 5.3: Main Body Graft Diameter Sizing Guide.

D1*,†

mmGraft Diameter‡

mm

18 - 19 22

20 - 21 24

22 26

23 - 24 28

25 - 26 30

27 - 28 32

*Maximum diameter along the proximal fixation site.†Round aortic diameter measurement to nearest mm.‡Additional considerations may affect choice of diameter.§All dimensions are nominal.

example:

Locate Intended Aortic Vessel Diameter (D1) in table 5.3 above = 22

Select Main Body Graft Diameter = 26

Main Body Order Number = ZALB-(graft diameter)-(cl length)

Main Body Order Number = ZALB-26-(cl length)

table 5.3Main Body Graft Diameter Sizing Guide§

60

Planning and Sizing

Considerations for Main Body Diameter

The length and angulation of the proximal aortic neck may influence the choice of main body diameter. A larger main body diameter may be appropriate in order to achieve satisfactory apposition with the vessel wall in a shorter, more angulated or irregularly shaped proximal aortic neck. Proximal neck diameter must be >15 mm long around the entire circumference of the aorta, and the angle from the neck to the aneurysm must be less than 60°. As these limits are approached, additional imaging to determine the true cross section at the proximal fixation site is recommended and a larger diameter of main body may be appropriate. For example, in the setting of tortuosity, it is assumed that the aorta is round and that oblique views on axial images appear elliptical and the short axis (minor) diameter is representative of the true diameter. If the aorta is not round, a larger size may be chosen to accommodate the true cross section.

Main Body Length

• l1 is the distance from lowest renal artery to aortic bifurcation + lateral deviation/tortuosity as described in step 2.

• cl is the main body length on the contralateral side. The cl length is measured from the proximal edge of the graft material to distal edge of the contralateral limb; cl is used in the Main Body Order Number.

• il is the main body length on the ipsilateral side. The il length is measured from the proximal edge of the graft material to distal edge of the ipsilateral limb.

• The ipsilateral limb of the main body is 24 mm longer than the contralateral limb. The goal in planning is to choose a main body length so that when it is placed in the most optimal proximal position (just below the lowest renal artery), the contralateral limb will be approximately 15 mm (at least 5 mm) above the aortic bifurcation, and the ipsilateral limb will extend approximately 15 mm into the common iliac artery.

• Based on L1 choose a main body component from table 5.4

61

L1mm

cl lengthmm

il lengthmm

75-92 70 94

89-102 84 108

103-112 98 122

113-122 108 132

123-132 118 142

133-142 128 152

L1 = distance from the lowest renal artery to aortic bifurcation + lateral deviation/tortuosity cl length = main body length on contralateral side il length = main body length on ipsilateral side

example:

Locate L1 in table 5.4 above = 105Select Main Body Graft of cl length = 98

Main Body Order Number = ZALB-(graft diameter)-(cl length)Main Body Order Number = ZALB-26-98

table 5.422mm to 32 mm Diameter Main Body Graft Length Sizing Chart

62

Planning and Sizing

Considerations for Main Body Selection

Refer also to Component Oversizing (Page 57).

Excessive main body oversizing may result in incomplete expansion, kinks or longitudinal folds in the graft causing endoleaks due to incomplete seal. A shorter main body may be selected if it is questionable whether the contralateral limb will open completely due to a narrowed distal aorta or the presence of thrombus or calcification. When selecting the main body component, if there is any question as to which of the two lengths to choose, use the shorter length. Compression or shortening of the segments of the graft is not recommended.

Incomplete opening (or expansion) of the contralateral limb of the main body may result from inadequate clearance between the contralateral limb of the main body and the aortic bifurcation. To reduce the potential for incomplete opening (or expansion) of the contralateral limb, a minimum distance of 5 mm between the most distal aspect of the contralateral limb and the aortic bifurcation is recommended. the most distal aspect of the ipsilateral limb of the main body must be 25 mm above the intended internal iliac artery to allow for ipsilateral iliac leg implantation. (Fig. 5.6)

Fig. 5.6Main Body Positioning with Respect to Aortic Bifurcation

≥ 5 mm

≥ 25 mm

63

steP 4: select the Contralateral Iliac leg graft

One of the advantages of the design of the Zenith Low Profile AAA Endovascular Graft is the variety of diameters and lengths of iliac legs to accommodate individual patient anatomy.

Contralateral Iliac Leg Graft Diameter

• d2 is the iliac diameter (measured outer wall to outer wall) at the contralateral distal fixation site. Use the largest diameter over the 20 mm length of the distal fixation site (> 10 mm).

• Using d2, select contralateral iliac leg diameter from table 5.5. Oversizing is included in the table.

D2 = Intended Iliac Vessel Diameter*,† (mm) Iliac Leg Graft Diameter‡ (mm)

8 - 9 10

10 - 11 12

12 - 13 14

14 - 15 16

16 - 17 18

18 20

19 22

20 24*Maximum diameter along the distal fixation site†Round iliac diameter measurement to nearest mm.‡Additional considerations may affect choice of diameter.§All dimensions are nominal.

example:

Locate D2 in table 5.5 above = 13Select Contralateral Iliac Leg Graft Diameter = 14

Contralateral Iliac Leg Graft Order Number = ZALL-(graft diameter)-(graft length)Contralateral Iliac Leg Graft Order Number = ZALL-14-(graft length)

table 5.5Iliac Leg Graft Diameter Sizing Guide§

64

Planning and Sizing

Contralateral Iliac Leg Graft Length

• l2 is the distance from lowest renal artery to contralateral distal fixation site.

• cl is the main body length on the contralateral side selected in step 3.

Calculate the Contralateral Working Length:

___ minus _________ = ___________________________ L2 cl Length Contralateral Working Length

• Based on the calculated Contralateral Working Length, choose the leg component (Iliac Leg Graft Order Length) from table 5.6. If there is more than one option for the Iliac Leg Graft Order Length, see Considerations for Contralateral Iliac Leg Graft Length Selection on the following page.


mm

Iliac Leg Graft Order Length

mm*

Recommended Overlap

Iliac Leg Stents

28 - 39 36† 2.5-3.5

40 - 51 48 2.5-3.5

52 - 63 60 2.5-3.5

64-75 72 2.5-3.5

76-87 84 2.5-3.5

88 - 99 96 2.5-3.5

100 - 111 108** 2.5-3.5

112 - 124 120*** 2.5-3.5*Other considerations may affect the choice of graft length†Assure adequate distal fixation length.**Graft length 108 mm is available in 10-14 mm diameters only***Graft length 120 mm is available in 10 and 12 mm diameters only

example:

When L2 = 141 mm cl = 98 mm as selected in step 3 Contralateral Working Length (mm) = L2 minus cl length (141 minus 98) = 43 mm

Locate Contralateral Working Length (mm) from table 5.6 above = 43 Select Iliac Leg Graft Order Length = 48

Contralateral Iliac Leg Graft Order Number = ZALL-(graft diameter)-(graft length) Contralateral Iliac Leg Graft Order Number = ZALL-14-48

table 5.6Contralateral Iliac Leg Graft Length Sizing Guide

65

Considerations for Contralateral Iliac Leg Graft Length Selection

Iliac leg lengths must be selected to:

• allow sufficient overlap with the main body

• cover the iliac arteries to just above the origin of the internal iliac (i.e., cover the diseased portion of the artery as well as a sufficient distal fixation zone)

• avoid internal iliac artery occlusion

Iliac legs are 32 mm longer than the Leg Order Length in order to allow 3 complete iliac leg stents ("sealing stents") to overlap with the limbs of the main body. (Fig. 5.5 & 5.7) There must be an overlap of at least 2.5 iliac leg stents between the leg and the main body on the contralateral side. (table 5.6) Contralateral iliac legs can generally be overlapped up to 3.5 stents. Too much overlap may increase the risk of limb folding or occlusion at the aortic bifurcation.

Fig. 5.7An iliac leg with a maximum useable length of 72 mm.

Note the 32 mm overlap in addition to the 72 mm maximum useable length.

24 mm

72 m

m

32 m

m

12 mm

66

Planning and Sizing

steP 5: select the Ipsilateral Iliac leg graft

One of the advantages of the design of the Zenith Low Profile AAA Endovascular Graft is the variety of diameters and lengths of iliac legs to accommodate individual patient anatomy.

Ipsilateral Iliac Leg Graft Diameter

• d3 is the iliac diameter (measured outer wall to outer wall) at the ipsilateral distal fixation site. Use the largest diameter over the 20 mm length of the distal fixation site (> 10 mm).

• Using d3, select an ipsilateral iliac leg diameter from table 5.7. Oversizing is included in the table.

D3 = Intended IliacVessel Diameter*,†

mm

Iliac LegGraft Diameter‡

mm

8 - 9 10

10 - 11 12

12 - 13 14

14 - 15 16

16 - 17 18

18 20

19 22

20 24 *Maximum diameter along the distal fixation site.†Round iliac diameter measurement to nearest mm. ‡Additional considerations may affect choice of diameter. §All dimensions are nominal

example:

Locate D3 in table 5.7 above = 17 Select Ipsilateral Iliac Leg Graft Diameter = 18

Ipsilateral Iliac Leg Graft Order Number = ZALL-(graft diameter)-(graft length) Ipsilateral Iliac Leg Graft Order Number = ZALL-18-(graft length)

table 5.7Iliac Leg Graft Diameter Sizing Guide§

67

Ipsilateral Iliac Leg Graft Length

• l3 is the distance from lowest renal artery to ipsilateral distal fixation site.

• il is the main body length on the ipsilateral side selected in step 3.

• Calculate the Ipsilateral Working Length:

___ minus _________ = ___________________________L3 il Length Ipsilateral Working Length

• Based on the calculated Ipsilateral Working Length, choose the ipsilateral leg component (Iliac Leg Graft Order Length) from table 5.8. If there is more than one option for the Iliac Leg Graft Order Length, see Considerations for Ipsilateral Iliac Leg Graft Length Selection on following page.

Ipsilateral WorkingLength mm

Iliac Leg Graft OrderLength mm*

RecommendedOverlap

Iliac Leg Stents

24 - 35 (graft diameter 18 - 24) 36 2.5 - 4

20 - 35 (graft diameter 10-16) 56 2.5 - 4

36 - 47 48 2.5 - 4

48 - 59 60 2.5 - 4

60 - 71 72 2.5 - 4

72 - 83 84 2.5 - 4

84 - 95 96 2.5 - 4

96 - 107 108** 2.5 - 4

108-124 120*** 2.5 - 4

*Other considerations may affect the choice of graft length.**Graft Length 108 mm is available in 10-14 mm diameters only.***Graft length 120 mm is available in 10 and 12 mm diameters only.

example:

When L3 = 191 mm il = 122 mm as selected in step 3Ipsilateral Working Length (mm) L3 minus il length (191 minus 122) = 69

Locate Ipsilateral Working Length (mm) from table 5.8 above = 69Select Iliac Leg Graft Order Length = 72

Ipsilateral Iliac Leg Graft Order Number = ZALL-(graft diameter)-(graft length)Ipsilateral Iliac Leg Graft Order Number = ZALL-18-72

table 5.8Ipsilateral Iliac Leg Graft Length Sizing Guide

68

Planning and Sizing

Considerations for Ipsilateral Iliac Leg Graft Length Selection

Iliac leg lengths must be selected to:

• allow sufficient overlap with the main body

• cover the iliac arteries to just above the origin of the internal iliac (i.e., cover the diseased portion of the artery as well as a sufficient distal fixation zone)

• avoid internal iliac artery occlusion

If a length of 36 mm was selected for a leg diameter of 10 to 16 mm, selection of a 48 mm leg length should be considered over a 36 mm length to allow for maximum overlap. (Fig. 5.8)For diameters of 18 to 24, overlap may be limited by leg taper and may result in longitudinal folding of the leg graft material causing luminal impingement.

If the calculated Working Length fits more than one leg option, consider the two following factors in choosing Leg Order Length:

• Selecting a Leg Order Length that provides more overlap between the main body and the ipsilateral iliac leg graft may increase the stability of the junction.

• Luminal impingement may occur when larger diameter (20 mm or greater) leg grafts are placed within the 11 mm diameter main body docking site due to the tapering of the segments.

Choose the extra length for increased stability at the junction, unless there is reason otherwise.

Fig. 5.8 Iliac Legs, 36 mm and 48 mm Length

36 m

m

48 mm

20 mm20 mm

12 mm

12 mm

36 m

m36

mm

69

Ancillary Component sizing

Main Body Extension

Main body extensions may be used to treat a Type I or Type I proximal endoleak. This may be caused by improper placement of the main body, tortuosity of the aortic neck, or inaccurate selection of the diameter of the main body.

In general, graft oversizing applies to all Zenith Low Profile AAA Endovascular Graft components. However, it may be appropriate to select the same size extension as the main body already placed within the vessel. In selecting the size of a body extension, neck shape, angulation, and the diameter of the existing main body should be considered.

• The lengths of main body extensions are 45 mm and 58 mm.

• A main body extension, if used, should be selected based on D1 and have a diameter no smaller than that of the main body. Recommended diameters are listed in table 5.9.

D1 = Intended Aortic Vessel Diameter*,†

mm

Main Body Extension Diameter‡

mm

Main Body Extension

Length mm

IntroducerSheath (ID/OD)

18 - 19 22 45/58 16 Fr (5.3mm)/6.0 mm

20 - 21 24 45/58 16 Fr (5.3mm)/6.0 mm

22 - 23 26 45/58 16 Fr (5.3mm)/6.0 mm

24 - 25 28 45/58 16 Fr (5.3mm)/6.0 mm

26 - 27 30 45/58 16 Fr (5.3mm)/6.0 mm

28 32 45/58 16 Fr (5.3mm)/6.0 mm

*Maximum diameter along the proximal fixation site.†Round aortic diameter measurement to nearest mm.‡Additional considerations may affect choice of diameter.§All dimensions are nominal.

example:

Locate D1 in table 5.9 above = 25 mm Select Main Body Extension = 28

Main Body Extension Order Number = ZLBE-(graft diameter)-45/58 Main Body Extension Order Number = ZLBE-28-45/58

table 5.9Main Body Extension Graft Diameter Sizing Guide§

70

Planning and Sizing

Considerations for an additional Iliac Leg

The use of an additional iliac leg may address several potential situations, and thereby avoid the need for open surgical conversion. A complete understanding of the considerations is important to achieve satisfactory results. Examples of situations in which an additional iliac leg may be useful include:

• A Type III endoleak due to inadequate overlap

• Iliac leg graft noted during the procedure to be too short

• A distal Type I endoleak due to inadequate seal at the distal fixation site

• Excessive overlap causing occlusion at main body bifurcation

Factors affecting the choice of approach include:

• Diameter of iliac at the internal iliac or distal fixation site

• Diameter of the iliac leg or other existing component

• Location of taper in the iliac leg

• The available lengths and diameters of additional iliac legs

• Anatomic factors that may affect placement or sealing

• The range of recommended overlap between the iliac leg and the limb of the main body: (2.5-3.5 stents on the contralateral side and 2.5-4 on the ipsilateral side)

• Actual length to be covered

A Type III endoleak due to inadequate overlap

If the iliac leg is not overlapped appropriately, or the iliac leg is moved during balloon inflation or manipulation, consider placing an additional iliac leg to bridge the junction of the main body and the leg. The number of components docked within the 11 mm main body limb need to be limited to avoid luminal impingement.

An iliac leg graft noted during the procedure to be too short

If, during the procedure, the length of the iliac leg is recognized to be too short for the straightened anatomy, a 12 mm iliac leg graft can be placed into the limb of the main body (i.e., bridge graft) followed by placement of the planned iliac leg or an appropriately sized extension.

Note that the diameter of the limb of the main body is 11 mm therefore additional iliac legs should be chosen to result in effective seals between components and with the intended vessel fixation site.

If the distance from the existing iliac leg to the new distal fixation site is not adequate to achieve a seal, a new fixation site in the external iliac may be appropriate. Consider the appropriateness of embolization of the internal iliac. The strategy for choosing the

71

diameter, length and/or combination of additional iliac legs involves evaluation of the iliac leg distal sealing stent diameter and the diameter of the new distal fixation site.

A distal Type I endoleak due to inadequate seal at the distal fixation site

After attempting to obtain a seal with ballooning, there are two approaches to obtaining a seal that involve an additional iliac leg:

1. Consider whether the distance from the existing iliac leg to the internal iliac bifurcation allows for the placement of an available iliac leg. Ensure that the common iliac has appropriate anatomy and diameter for a distal fixation site.

Extend from the iliac leg to a new distal fixation site. The strategy for choosing the diameter, length and/or combination of additional iliac legs involves evaluation of the iliac leg distal sealing stent diameter and length and the diameter of the new distal fixation site.

2. If the distance from the iliac leg to the iliac bifurcation or the iliac anatomy is insufficient for placement of an additional iliac leg from the existing iliac leg to a new distal fixation site proximal to the iliac bifurcation, consider the potential of extending from the existing iliac leg to a new distal fixation site in the external iliac artery. Consider the appropriateness of embolization of the internal iliac.

Extend from the main body to a new distal fixation site. In order to avoid multiple junctions and minimize the risk of endoleak, extending from the limb of the main body to the newly selected distal fixation site may be the best option.

Excessive overlap causing occlusion of main body bifurcation

If the contralateral iliac leg is placed such that it extends up into the main body beyond the recommended overlap, resulting in occlusion or restriction of flow, consider providing more support for the contralateral leg by placing the ipsilateral leg further into the main body adjacent to the contralateral leg (i.e., kissing stents). When increasing the overlap on the ipsilateral side, ensure that the new distal fixation site will still provide an adequate seal. An additional iliac leg may be needed.

In each case, the strategy should be designed with a complete understanding of the components available, the need for effective seals, graft-to-graft and between the graft and vessel. other anatomic factors that may affect outcome should be considered.

72

Planning and Sizing

Converter

The converter is used when the bifurcated main body has been positioned and access to the contralateral limb of the main body is unattainable. The converter converts the bifurcated endovascular graft into an aortouni-iliac endovascular graft.

In general, graft oversizing applies to all Zenith Low Profile AAA Endovascular Graft components. However, it may be appropriate to select the same size converter as main body due to the presence of the stents and graft material already placed within the vessel.

Attention should be given to the exact placement of the converter sealing stent within the main body to assure adequate graft-to-graft seal. If implanted properly, the two distal stents on the converter should land within the iliac limb of the main body.

The length of all converters is 66 mm. The distal diameter of all converters is 12 mm.

A converter, if used, should have a diameter no smaller than that of the main body.

Recommended diameters are listed in table 5.10.

Main Body Diameter

mm

Converter Diameter*

mm

ConverterLength

mmIntroducer

Sheath (ID/OD)

22 24 66 16 Fr (5.3 mm)/6.0 mm

24 24 66 16 Fr (5.3 mm)/6.0 mm

26 28 66 16 Fr (5.3 mm)/6.0 mm

28 28 66 16 Fr (5.3 mm)/6.0 mm

30 32 66 16 Fr (5.3 mm)/6.0 mm

32 32 66 16 Fr (5.3 mm)/6.0 mm*Additional considerations may affect choice of diameter.†All dimensions are nominal

example

Locate Main Body Diameter in table 5.10 above = 28Select Converter Diameter = 28

Converter Order Number = ZLC-(graft diameter)-66Converter Order Number = ZLC-28-66

table 5.10Converter (ZLC) Graft Diameter Sizing Guide†

CHAPTER 6Deployment

6

Deployment

76

Bifurcated System

Deployment

suggested deployment steps from the Instructions for Use of the zenith low Profile AAA endovascular graft with the h&l-b one-shot Introduction system

Bifurcated System

Bifurcated Main Body Preparation/Flush

Contralateral Iliac Leg Preparation/Flush

Ipsilateral Iliac Leg Preparation/Flush

Vascular Access and Angiography

Main Body Placement

Contralateral Iliac Wire Guide Placement

Main Body Proximal (Top) Deployment

Contralateral Iliac Leg Placement and Deployment

Main Body Distal (Bottom) Deployment

Docking of Top Cap

Ipsilateral Iliac Leg Placement and Deployment

Molding Balloon Insertion

Ancillary Devices

Converter

Main Body Extensions

Bifurcated System

Deployment

sInstructions for UseAAA s

Bifurcated SystemBifurcated System

Ancillary DevicesAncillary Devices

77

Prior to use of the Zenith Low Profile AAA Endovascular Graft with the H&L-B One-Shot Introduction System, review these deployment steps from the Instructions for Use of the Zenith Low Profile AAA Endovascular Graft with the H&L-B One-Shot Introduction System. The following instructions embody a basic guideline for device placement. Variations in the following procedures may be necessary. These instructions are intended to help guide the physician and do not take the place of physician judgement.

Bifurcated System

General Use Information

Standard techniques for placement of arterial access sheaths, guiding catheters, angiographic catheters and wire guides should be employed during use of the Zenith Low Profile AAA Endovascular Graft with the H&L-B One-Shot Introduction System. The Zenith Low Profile AAA Endovascular Graft with the H&L-B One-Shot Introduction System is compatible with .035 inch diameter wire guides.

Hub Pin Vise

Grey Positioner

Stopcock

Connecting Tube

Flexor® Introducer Sheath

Dilator TipSheath Sideport

Safety Locks

Captor® Hemostatic Valve

Ipsilateral Limb Trigger-Wire

Release Mechanism

Top Stent Trigger-Wire

Release Mechanism

Inner Cannula

Main Body Graft

Peel-Away® Sheath

Bifurcated Main Body

H&L-B Pre-loaded

Delivery System

Hub Pin Vise

Grey Positioner

Stopcock

Connecting Tube

Introducer Sheath Dilator

Tip

Sheath SideportCaptor® Hemostatic

Valve

Inner Cannula

Iliac Leg Graft

Peel-Away® Sheath

Iliac Leg

H&L-B Pre-loaded

Delivery System

Fig. 6.1

Deployment

78

Pre-Implant Determinants

Verify from pre-implant planning that the correct device has been selected. Determinants include:

1. Femoral artery selection for introduction of the main body system (i.e., define respective contralateral and ipsilateral iliac arteries).

2. Angulation of aortic neck, aneurysm and iliac arteries.

3. Quality of the aortic neck.

4. Diameters of infrarenal aortic neck and distal iliac arteries.

5. Distance from renal arteries to the aortic bifurcation.

6. Length from the aortic bifurcation to the internal iliac arteries/attachment site(s).

7. Aneurysm(s) extending into the iliac arteries may require special consideration in selecting a suitable graft/artery interface site.

8. Consider the degree of vascular calcification.

Patient Preparation

1. Refer to institutional protocols relating to anesthesia, anticoagulation and monitoring of vital signs.

2. Position patient on imaging table allowing fluoroscopic visualization from the aortic arch to the femoral bifurcations.

3. Both common femoral arteries should be prepared using standard techniques for either surgical or percutaneous access.

Bifurcated Main Body Preparation/Flush

1. Remove black-hubbed shipping stylet (from the inner cannula), cannula protector tube (from the inner cannula) and dilator tip protector (from the dilator tip). Remove Peel-Away sheath from back of the hemostatic valve. (Fig. 6.2) Elevate tip of system and flush through the stopcock on the Captor Hemostatic Valve until fluid emerges from the sideport near the tip of the introducer sheath. (Fig. 6.3) Continue to inject a full 20 cc of flushing solution through the device. Discontinue injection and close stopcock on connecting tube.

note: Hold the dilator while removing the dilator tip protector to prevent pulling back the sheath prematurely.

note: Graft flushing solution of heparinized saline is often used. note: When proceeding to remove the Peel-Away sheath from the back of the hemostatic valve, ensure that the delivery system sheath is held stationary against the dilator tip to limit possible movement.

2. Attach syringe with heparinized saline to the hub on the inner cannula. Flush until fluid exits the dilator tip. (Fig. 6.4)

note: When flushing system, elevate distal end of system to facilitate removal of air.

Fig. 6.2

Fig. 6.3

Fig. 6.4

79

3. Soak sterile gauze pads in saline solution and use to wipe Flexor introducer sheath to activate the hydrophilic coating. Hydrate both sheath and dilator liberally.

Iliac Leg Preparation/Flush

1. Remove black-hubbed inner stylet (from the inner cannula), cannula protector tube (from the inner cannula) and dilator tip protector (from the dilator tip). Remove Peel-Away sheath from back of the hemostatic valve. (Fig. 6.5a) Elevate distal tip of system and flush through the stopcock on the hemostatic valve until fluid emerges from the sideport near the tip of the introducer sheath. (Fig. 6.5b) Continue to inject a full 20 cc of flushing solution through the device. Discontinue injection and close stopcock on connecting tube.


note: Graft flushing solution of heparinized saline is often used.note: When proceeding to remove the Peel-Away sheath from the back of the hemostatic valve, ensure that the delivery system sheath is held stationary against the dilator tip to limit possible movement.

2. Attach syringe with heparinized saline to the hub on the distal inner cannula. Flush until fluid exits the dilator tip. (Fig. 6.6)

note: When flushing system, elevate distal end of system to facilitate removal of air.

Vascular Access and Angiography

1. Puncture the selected common femoral arteries using standard technique with an 18 or 19UT gage arterial needle. Upon vessel entry, insert:

• Wire guides - standard .035 inch diameter, 145 cm long, J tip or Bentson Wire Guide

• Appropriate size sheaths (e.g., 6 or 8 French)

• Flush catheter (often radiopaque sizing catheters - e.g., Centimeter Sizing Catheter or straight flush catheter)

2. Perform angiography to identify level(s) of renals, aortic bifurcation and iliac bifurcations.

note: If fluoroscope angulation is used with an angulated neck it may be necessary to perform angiograms using various projections.

Main Body Placement

1. Ensure the delivery system has been flushed with heparinized saline and that all air is removed from the system.

2. Give systemic heparin and check flushing solutions. Flush after each catheter and/or wire guide exchange.

note: Monitor the patient’s coagulation status throughout the procedure.

Fig. 6.5b

Fig. 6.5a

Fig. 6.6

Deployment

80

3. On ipsilateral side, replace J wire with stiff wire guide (LES) .035 inch, 260 cm long and advance through catheter and up to the thoracic aorta. Remove flush catheter and sheath. Maintain wire guide position.

4. Before insertion, position main body delivery system on patient’s abdomen under fluoroscopy to determine the orientation of the contralateral limb radiopaque marker. The sidearm of the hemostatic valve may serve as an external reference to the contralateral limb radiopaque marker.

5. Insert main body delivery system over the wire, into the femoral artery with attention to sidearm reference.

CAutIon: Maintain wire guide position during delivery system insertion.

CAutIon: to avoid any twist in the endovascular graft, during any rotation of the delivery system, be careful to rotate all of the components of the system together (from outer sheath to inner cannula).

6. Advance delivery system until the four gold radiopaque markers (which are positioned 2 mm from the most proximal segment of the graft material) (Fig. 6.7, Illustration 1) are just inferior to the most inferior renal orifice.

7. Verify position of wire guide in the thoracic aorta. Ensure the graft system is oriented such that the contralateral limb is positioned above and anterior to the origin of the contralateral iliac. If the contralateral limb radiopaque

1

7

2

4

5

6

3

Fig. 6.7

81

marker is not properly aligned, rotate the entire system until it is correctly positioned half way between a lateral and an anterior position on the contralateral side.

• A marker formation of a ✓ indicates an anterior position of the short (contralateral) limb. (Fig. 6.7, Illustration 4)

• A marker formation of a indicates a posterior position of the short (contralateral) limb. (Fig. 6.7, Illustration 5)

• A marker formation of a l line indicates a lateral position of the short (contralateral) limb. (Fig. 6.7, Illustration 6)

8. Repeat the angiogram to verify the four gold radiopaque markers are 2 mm or more below the most inferior renal orifice.

9. Ensure the Captor Hemostatic Valve is turned to the open position. (Fig. 6.8)

10. Stabilize the grey positioner (the shaft of the delivery system) while withdrawing the sheath. Deploy the first two covered stents by withdrawing the sheath while monitoring device location.

note: The delivery system does not utilize a top cap; however, the stent graft has a suprarenal stent with barbs. The device should be accurately positioned before the outer sheath is withdrawn.

11. Without moving the table, decrease the magnification to check on the position of the contralateral limb radiopaque marker and location of renal arteries. Proceed with the deployment until the contralateral limb is fully deployed. (Fig. 6.9) Stop withdrawing the sheath.

note: Verify the contralateral limb is at least 5 mm above the aortic bifurcation and in desired location for cannulation.

12. Repeat the angiogram and reposition if necessary.

13. Remove the safety lock from the gold trigger-wire release mechanism. Withdraw trigger-wires (deploying the suprarenal stent) by sliding the gold trigger-wire release mechanism off the handle and then remove via its slot over the device inner cannula. (Fig. 6.10)

note: Once the barbed suprarenal stent has been deployed, further attempts to reposition the graft are not recommended.

wARnIng: the zenith low Profile AAA endovascular graft incorporates a suprarenal stent with fixation barbs. exercise extreme caution when manipulating interventional devices in the region of the suprarenal stent.

Contralateral Iliac Wire Guide Placement

1. Manipulate catheter and wire guide through open end of contralateral limb into body of the graft. Advance the wire guide inside the body of the graft and into the thoracic aorta. AP and oblique fluoroscopic views can aid in verification of device cannulation.

Fig. 6.8

Fig. 6.9

Fig. 6.10

Deployment

82

2. After cannulation, advance the angiographic catheter over the wire into the body of the endovascular graft. Remove wire and perform angiography to confirm position. Advance wire guide inside the body of the graft and into the thoracic aorta. Remove angiographic catheter.

Contralateral Iliac Leg Placement and Deployment

CAutIon: verify that the predetermined contralateral iliac leg is selected for insertion on the contralateral side of the patient before implantation.

1. Position the image intensifier to show both the contralateral internal iliac artery and contralateral common iliac artery.

2. Prior to the introduction of the contralateral iliac leg delivery system, inject contrast through the contralateral femoral sheath to locate the contralateral internal iliac artery.

3. Introduce the contralateral iliac leg delivery system into the artery. Advance slowly until the gold radiopaque marker on the iliac leg graft aligns with the gold checkmark of the main body graft, giving approximately 3 stents’ overlap between components. (Fig. 6.11) If there is any tendency for the main body graft to move during this maneuver, hold it in position by stabilizing the positioner on the ipsilateral side.

note: If difficulty is encountered advancing the iliac leg delivery system, exchange to a more supportive wire guide. In tortuous vessels, the anatomy may alter significantly with the introduction of the rigid wires and sheath systems.

4. Confirm position of distal end of the contralateral iliac leg graft. Reposition the contralateral iliac leg graft if necessary to ensure both internal iliac patency and minimum overlap of 2.5 stents (i.e., proximal stent of iliac leg graft, maximum overlap of 3.5 stents) within the main body endovascular graft.

note: Ensure Captor Hemostatic Valve on the iliac leg introducer sheath is turned to the open position. (Fig. 6.8)

5. To deploy, hold the contralateral iliac leg graft in position with the grey positioner while withdrawing the sheath approximately 10 mm. (Figs. 6.12 and 6.13)

6. Check the graft position and reposition if necessary.

7. Continue to deploy the graft by pulling back the sheath while continuously checking the position of the graft.

8. Stop withdrawing the sheath as soon as the distal end of the contralateral iliac leg graft is released.

9. Under fluoroscopy and after verification of iliac leg graft position, loosen pin vise, retract inner cannula to dock tapered dilator to positioner. Tighten pin vise. Maintain sheath position while withdrawing grey positioner with secured inner cannula. (Fig. 6.14)

10. Close the Captor Hemostatic Valve on the iliac leg introducer sheath by turning it in a clockwise direction until it stops. (Fig 6.19)

11. Re-check the position of the wire guide.

Fig. 6.14

Fig. 6.11 Fig. 6.12

Fig. 6.13

83

Main Body Distal (Bottom) Deployment

1. Return to the ipsilateral side.

2. Fully deploy the ipsilateral limb of the main body by withdrawing the sheath until the most distal stent has expanded. (Fig. 6.15) Stop withdrawing the sheath.

note: The distal stent is still secured by the trigger-wire.

3. Remove the safety lock from the black trigger-wire release mechanism. Withdraw and remove the trigger-wire by sliding the black trigger-wire release mechanism off the handle and then remove via its slot over the device inner cannula. (Fig. 6.16)

4. Loosen the pin vise; retract inner cannula to dock tapered dilator to positioner. (Fig. 6.17) Tighten the pin vise.

5. Withdraw the entire inner subassembly through the sheath by pulling on the inner cannula. Leave the sheath and wire guide in place. (Fig. 6.18)

note: Maintain position of sheath and wire guide.

6. Close the Captor Hemostatic Valve on the introducer sheath by turning it in a clockwise direction until it stops. (Fig. 6.19)

Ipsilateral Iliac Leg Placement and Deployment

note: Ensure the Captor Hemostatic Valve on the introducer sheath is turned to the open position. (Fig. 6.20)

1. Utilize the main body graft wire and sheath assembly to introduce the ipsilateral iliac leg graft. Advance dilator and sheath assembly into the main body sheath.

note: In tortuous vessels, the position of the internal iliac arteries may alter significantly with the introduction of the rigid wires and sheath systems.

2. Advance slowly until the gold radiopaque marker on the iliac leg aligns with the gold markers on the ipsilateral limb of the main body, giving approximately 3 stents’ overlap between components. (Fig. 6.21)

note: If a greater overlap is required, it may be necessary to consider use of another iliac leg in the bifurcation area of the opposite side.

3. Confirm position of distal end of the iliac leg graft. Reposition the iliac leg graft if necessary to ensure internal iliac patency and a minimum overlap of 2.5 stents (i.e., proximal stent of the iliac leg graft, maximum overlap of 4 stents) within the main body endovascular graft.

note: Ensure Captor Hemostatic Valve on the iliac leg introducer sheath is turned to the open position. (Fig. 6.8)

4. To deploy, hold the iliac leg graft in position with the grey positioner while withdrawing the sheath approximately 10 mm. (Figs. 6.22a and 6.22b)

5. Check the graft position and reposition if necessary.

6. Continue to deploy the graft by pulling back the sheath and continuously check the position of the graft.

Fig. 6.15

Fig. 6.16 Fig. 6.17

Fig. 6.18

Fig. 6.19

Deployment

84

7. Under fluoroscopy and after verification of iliac leg graft position, loosen pin vise, retract inner cannula to dock tapered dilator to positioner. Tighten pin vise. Maintain sheath position while withdrawing positioner with secured inner cannula. (Fig. 6.23)

8. Close the Captor Hemostatic Valve on the main body introducer sheath by turning it in a clockwise direction until it stops.

9. Re-check the position of the wire guides. Leave sheath and wire guides in place.

Molding Balloon Insertion

1. Prepare molding balloon as follows:

• Flush wire lumen with heparinized saline.

• Remove all air from balloon.

2. In preparation of the insertion of the molding balloon, open the Captor Hemostatic Valve by turning counter-clockwise.

3. Advance the molding balloon over the wire guide and through the hemostatic valve of the main body introduction system to the level of the renal arteries. Maintain proper sheath positioning.

4. Tighten the Captor Hemostatic Valve around the molding balloon with gentle pressure by turning it clockwise.

CAutIon: do not inflate the balloon in the vessel outside of the graft.

5. Expand the molding balloon with diluted contrast media (as directed by the manufacturer) in the area of the most proximal covered stent and the infrarenal neck, starting proximally and working in the distal direction. (Fig. 6.24)

CAutIon: Confirm complete deflation of balloon prior to repositioning. CAutIon: Captor hemostatic valve must be open prior to repositioning of molding balloon.

6. Withdraw the molding balloon to the ipsilateral limb overlap and expand.

CAutIon: Captor hemostatic valve must be open prior to repositioning of molding balloon.

7. Withdraw the molding balloon to the ipsilateral distal fixation site and expand.


8. Deflate and remove molding balloon. Transfer the molding balloon onto the contralateral wire guide and into the contralateral iliac leg introduction system. Advance molding balloon to the contralateral limb overlap and expand.

Fig. 6.20

Fig. 6.21

Fig. 6.22bFig. 6.22a

85

Fig. 6.23

Fig. 6.24

CAutIon: Confirm complete deflation of balloon prior to repositioning.

9. Withdraw the molding balloon to the contralateral iliac leg/vessel distal fixation site and expand. (Fig. 6.24)


10. Remove molding balloon and replace it with an angiographic catheter to perform completion angiograms.

11. Remove or replace all stiff wire guides to allow iliac arteries to resume their natural position.

Final Angiogram

1. Position angiographic catheter just above the level of the renal arteries. Perform angiography to verify that the renal arteries are patent and that there are no endoleaks. Verify patency of internal iliac arteries.

2. Confirm there are no endoleaks or kinks and verify position of proximal gold radiopaque markers. Remove the sheaths, wires and catheters.

note: If endoleaks or other problems are observed, refer to section 10.2, Ancillary devices.

3. Repair vessels and close in standard surgical fashion.Balloon Expansion/Graft Sealing Sites

Deployment – Ancillary Devices

86

Deployment

suggested deployment steps from the Instructions for Use of the zenith low Profile AAA endovascular graft — Ancillary devices

Ancillary Devices

General Use Information

Inaccuracies in device size selection or placement, changes or anomalies in patient anatomy or procedural complications can require placement of additional endovascular grafts, extensions, iliac plugs and converters. Regardless of the device placed, the basic procedure(s) will be similar to the maneuvers required and described previously in this document. It is vital to maintain wire guide access.

Standard techniques for placement of arterial access sheaths, guiding catheters, angiographic catheters and wire guides should be employed during use of the Zenith Low Profile AAA Endovascular Graft ancillary devices.

The Zenith Low Profile AAA Endovascular Graft ancillary devices with the H&L-B One Shot Introduction Systems are compatible with .035 inch wire guides.

Fig. 6.25

Dilator Tip

CONVERTERH&L-B One-Shot

Pre-Loaded Delivery System

Stopcock

Connecting Tube

Flexor Introducer Sheath

Sheath Sideport

Converter

Hemostatic Valve

Grey Positioner



Peel-Away SheathHub Pin Vise

Safety Lock

MAIN BODY EXTENSIONH&L-B One-Shot

Pre-Loaded Delivery System

Black Trigger-Wire

Release Mechanism

Inner Cannula Hemostatic

Valve

Peel-Away Sheath

Connecting Tube

Flexor Introducer Sheath Dilator Tip

Sheath Sideport

Hub Pin Vise

Safety Lock

Grey Positioner

Main Body Extension

Stopcock

Deployment

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Converter

Converters can be used to convert a bifurcated graft into an aortouni-iliac graft, if necessary (e.g., cases of Type III endoleak, limb occlusion or unattainable contralateral limb cannulation). (Fig. 6.26)

Converter Preparation/Flush

1. Remove inner stylet (from the inner cannula), cannula protector (from the inner cannula) and dilator tip protector (from the dilator tip). Remove Peel-Away sheath from back of the hemostatic valve. (Fig. 6.27) Elevate distal tip of the system and flush through the stopcock on the hemostatic valve until fluid emerges from the tip of the introducer sheath. (Fig. 6.5b) Continue to inject a full 20 cc of flushing solution through the device. Discontinue injection and close stopcock.


note: Graft flushing solution of heparinized saline is often used.

2. Attach syringe with heparinized saline to the hub of the inner cannula. Flush until fluid exits the dilator tip. (Fig. 6.6)

note: When flushing system, elevate distal end of the system to facilitate removal of air.


Converter Placement and Deployment

1. Remove main body delivery sheath. Use the main body graft wire guide to introduce the converter into the main body.

note: The converter delivery system cannot be introduced through the main body or iliac leg introducer sheath.

2. Advance slowly until the converter is at the site of the required intervention. (Fig. 6.28) Verify appropriate stent graft overlap to ensure proper sealing and resistance to migration. The proximal two stents should be positioned in the main body graft and the distal two stents should be positioned in the ipsilateral leg.

3. Ensure the Captor Hemostatic Valve is turned to the open position. (Fig. 6.8)

Fig. 6.27

Fig. 6.28

Fig. 6.26

Dilator Tip

Stopcock

Connecting Tube

Flexor Introducer Sheath

Sheath Sideport

Converter

Hemostatic Valve

Grey Positioner



Peel-Away Sheath

Hub Pin Vise

Safety Lock

88

4. Deploy the device by withdrawing the sheath while stabilizing the grey positioner of the delivery system. (Figs. 6.12 and 6.29)

5. Remove the safety lock from the black trigger-wire release mechanism. Withdraw and remove the trigger-wire by sliding the black trigger-wire release mechanism off the handle, and then remove via the slot over the inner cannula. (Fig. 6.16)

6. Continue to deploy the device until the distal stent is uncovered.

7. Withdraw the tapered tip of the introducer back through the converter graft and delivery system while maintaining wire guide position. Ensure the endovascular graft is not displaced during the withdrawal of delivery system.

8. Close the Captor Hemostatic Valve by turning it in a clockwise direction until it stops. (Fig. 6.19)

Converter Molding Balloon Insertion

note: For information on the use of recommended products, refer to the individual product’s Instructions for Use.





2. Advance the molding balloon over the wire guide and through the hemostatic valve to the proximal segment of the converter.


4. Expand the molding balloon within the proximal segment and the distal segment of the converter using diluted contrast media (as recommended by the manufacturer). (Fig. 6.30)

CAutIon: Confirm complete deflation of the balloon prior to repositioning.

5. Completely deflate and remove the molding balloon, replace it with an angiographic catheter and perform completion angiograms.

6. If no other endovascular maneuvers are necessary, remove any sheaths, wires and catheters. Repair vessels and close in standard surgical fashion.

Fig. 6.29

Fig. 6.30

Balloon Expansion/Graft Sealing Sites

Deployment

89

Fig. 6.32

10.2.2 Main Body Extensions

Main body extensions are used for extending the proximal body of an in situ endovascular graft. (Fig. 6.31)

Main Body Extension Preparation/Flush

1. Remove inner stylet (from the inner cannula), cannula protector (from the inner cannula) and dilator tip protector (from the dilator tip). Remove Peel-Away sheath from back of the hemostatic valve. (Fig. 6.27) Elevate distal tip of the system and flush through the stopcock on the hemostatic valve until fluid emerges from the tip of the introducer sheath. (Fig. 6.5b) Continue to inject a full 20 cc of flushing solution through the device. Discontinue injection and close stopcock.


note: Graft flushing solution of heparinized saline is often used.

2. Attach syringe with heparinized saline to the hub of the inner cannula. Flush until fluid exits the dilator tip. (Fig. 6.6)

note: When flushing system, elevate distal tip of the system to facilitate removal of air.


Main Body Extension Placement and Deployment

1. Remove main body delivery sheath. Use the main body graft wire guide to introduce the main body extension into the main body.

note: The main body extension delivery system cannot be introduced through the main body or iliac leg introducer sheath.

2. Advance slowly until the main body extension is at the site of the required intervention. (Fig. 6.32)

3. Verify the main body extension position to ensure proper sealing and resistance to migration.

4. Verify the placement with angiography to ensure that the renal arteries remain patent and that proper placement is achieved.

CAutIon: Care should be taken not to displace the main body graft during the placement and deployment of the main body extension.

Fig. 6.31

Black Trigger-Wire

Release Mechanism

Inner Cannula Hemostatic

Valve

Peel-Away Sheath

Connecting Tube

Flexor Introducer Sheath Dilator Tip

Sheath Sideport

Hub Pin Vise

Safety Lock

Grey Positioner

Main Body Extension

Stopcock

90

Fig. 6.33

Fig. 6.34

5. Ensure the Captor Hemostatic Valve is turned to the open position. (Fig 6.8)

6. Deploy the device by withdrawing the sheath while stabilizing the grey positioner of the delivery system. (Figs. 6.12 and 6.33) Continue to deploy the device until the most distal stent is uncovered. Stop withdrawing the sheath.

7. Remove the safety lock from the black trigger-wire release mechanism. Withdraw and remove the trigger-wire by sliding the black trigger-wire release mechanism off the handle, and then remove via the slot over the inner cannula. (Fig. 6.16)

8. Withdraw the tapered tip of the introducer back through the main body extension graft and delivery system while maintaining wire guide position. Ensure the main body extension and endovascular graft are not displaced during withdrawal of the delivery system.

9. Close the Captor Hemostatic Valve by turning it in a clockwise direction until it stops. (Fig. 6.19)

Main Body Extension Molding Balloon Insertion

note: For information on the use of recommended products, refer to the individual product’s Instructions for Use.





2. Advance the molding balloon over the wire guide and through the hemostatic valve of the main body introduction system to the level of the main body extension.



4. Expand the molding balloon within the proximal segment of the main body extension and then the most distal segment of the main body extension using diluted contrast media (as recommended by the manufacturer). (Fig. 6.34)


5. Completely deflate and remove the molding balloon, replace it with an angiographic catheter and perform completion angiograms.

6. If no other endovascular maneuvers are necessary, remove any sheaths, wires and catheters. Repair vessels and close in standard surgical fashion.

1Balloon Expansion/Graft Sealing Sites

CHAPTER 7Facilities & Supplemental Equipment

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Facilities & Supplemental Equipment

Endovascular AAA repair is best achieved utilizing a multi-disciplinary team approach.

Facilities

The following should be available in the procedure room.

Imaging

Fluoroscopic imaging equipment should include digital angiography capabilities (C-arm or fixed unit) and the ability to record and recall all imaging. The procedure table must be compatible with the C-arm if used, allowing free movement under the table. A second monitor allows operators and support staff to view the procedure from both sides of the table.

Film Reviewing Capability

Often during the endovascular grafting procedure it is necessary to review preoperative images. The availability of a picture archiving computer system (PACS) station or a traditional view box is essential to verify patient anatomy prior to and during deployment.

Power Contrast Injector

A power contrast injector, with sterile high-pressure connecting tubing and injector syringes, is a necessary tool for the endovascular procedure.

Radiation Protection

Sufficient lead shielding, including lead aprons and thyroid shields, are to be available for all team members. Radiation monitoring badges are to be worn in compliance with institutional requirements.


Ancillary components are available if needed to extend a main body or iliac leg, or to convert a bifurcated graft into an aortouni-iliac graft. Refer to the Ancillary Components section of the reference manual for more details.

Supplemental Equipment

Supplemental equipment may include needles, wire guides, sheaths, catheters, embolization coils, snares, angioplasty balloon catheters, peripheral stents, and molding balloons. Refer to the next section for required and optional items.

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supplemental equipment

Placement of the Zenith Low Profile AAA Endovascular Graft requires both surgical and interventional expertise, coupled with an understanding of various imaging techniques.

Wire Guides

Several wire guides may be required during the placement of the Zenith Low Profile AAA Endovascular Graft. Initial arterial access often requires the use of a J-wire or Bentson wire to allow safe placement of angiographic catheters and sheaths into the abdominal aorta. Extra support wire guides are also required to ease device insertion and tracking. The Lunderquist Extra-Stiff Wire is used with the Zenith system to help straighten tortuous anatomy during device advancement and deployment. Cannulation of the contralateral limb during placement of a bifurcated Zenith device often requires the use of a selective hydrophilic wire guide such as the Nimble® and other devices. When used with a selective angiographic catheter, these wires aid access through difficult or tortuous anatomy.

Lunderquist Extra-Stiff Wire GuidesTSMG-35-260-LES

TSCMG-35-300-LES

TSCMG-35-260-7-LES

TSCMG-35-300-7-LES

TSCMG-35-260-LESDC

TSCMG-35-300-LESDC

Amplatz Ultra-Stiff Wire GuidesTHSF-35-260-AUS2

THSCF-35-260-3-AUS2

Amplatz Extra-Stiff Wire GuidesTHSF-35-260-AES

THSCF-35-260-3-AES

Nimble Roadrunner® PC Wire GuidesRFSPC-35-145

RFSPC-35-180

RFSPC-35-260

Straight Bentson Fixed Core Wire GuidesTSFB-35-145

TSFB-35-180

TSFB-35-260-BH

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Facilities & Supplemental Equipment

Introducer Sets, Entry Needles, Dilators

and Embolization Coils

Placement of additional introducer sheaths or catheters via the Seldinger Technique is common with endovascular repair of arterial aneurysms. Introducer sheaths and vessel dilators are often used prior to the insertion of the Zenith Low Profile AAA Endovascular Graft to allow pre-placement angiogram analysis of the arterial anatomy.

Check-Flo Performer® Introducer Sets — Standard Lengths (13 cm)RCF-6.0-38-J

RCF-8.0-38-J

Check-Flo Performer® Introducer Sets — Long Lengths (25 cm)RCFW-6.0-38-25

RCFW-8.0-38-25

Disposable Percutaneous Entry Thinwall NeedleSDN-18-7.0

Endovascular Dilator SetJCDS-14-EDS-HC

JCDS-1618-EDS-HC

JCDS-2022-EDS-HC

JCDS-2024-EDS-HC

JCDS-2426-EDS-HC

Nester® Embolization CoilsMWCE-35-14-4-NESTER

MWCE-35-14-6-NESTER

MWCE-35-14-8-NESTER

MWCE-35-14-10-NESTER

MWCE-35-14-12-NESTER

Tornado® Embolization CoilsMWCE-35-5/3-TORNADO

MWCE-35-6/3-TORNADO

MWCE-35-7/3-TORNADO

MWCE-35-8/4-TORNADO

MWCE-35-8/5-TORNADO

MWCE-35-10/5-TORNADO

Angiographic Catheters

Deployment depends on angiographic localization of anatomic landmarks such as the renal and internal iliac arteries. Straight and pigtail flush catheters allow for abdominal aortograms to be performed. Sizing catheters allow for accurate vessel sizing to be determined prior to aortic graft placement. Angled-tip catheters aid in traversing diseased iliac arteries and in catheterizing the contralateral limb attachment site.

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Beacon® Tip Torcon NB® Advantage Angiographic CathetersHNBR5.0-38-65-P-NS-C2

HNBR5.0-38-65-P-NS-KMP

HNBR5.0-38-65-P-NS-RIM

HNBR5.0-38-80-P-NS-VS

HNBR5.0-38-80-P-NS-VS1

Diagnostic Catheters

Beacon® Tip Van Schie Seeking CathetersHNBR5.0-35-65-P-NS-VANSCHIE1

HNBR5.0-35-65-P-NS-VANSCHIE2




Aurous® Centimeter Sizing Catheters — PigtailNR5.0-35-70-P-10S-PIG-CSC-20

N5.0-35-100-P-10S-PIG-CSC-20

Aurous® Centimeter Sizing Catheter — StraightNR5.0-35-70-P-10S-O-CSC-20

Beacon® Tip Royal Flush® Plus — Pigtail High-Flow Angiographic Catheters

HNR5.0-35-70-P-10S-PIG

HNR5.0-35-100-P-10S-PIG

Beacon® Tip Royal Flush® Plus — Straight High-Flow Angiographic Catheters

HNR5.0-35-70-P-10S-0

HNR5.0-35-100-P-10S-0

Royal Flush Plus Van Schie Over-The-Top Flush CathetersHN8.0-35-120-Y-6S-VOTT

HN8.0-35-80-Y-6S-VOTT

Connecting Tubes

Angiographic catheters and flush catheters are connected to injectors via high-pressure lines.

Connecting TubesHPCT8.8-120-P-FM

Molding Balloons

Molding balloon catheters are used to fully expand the Zenith Low Profile AAA Endovascular Graft and ensure full apposition with all attachment sites and between all components.

Coda® Balloon CatheterCODA-10.0-35-100-32

CODA-10.0-35-120-40

CODA-2-10.0-35-120-32

CODA-2-10.0-35-120-40

CHAPTER 8Troubleshooting

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100

Troubleshooting

troubleshooting

Introduction

note: these recommendations are designed to serve only as a general guideline. they are not intended to supersede institutional protocols or professional clinical judgement concerning patient care.

Troubleshooting information is organized in the following sections:

Patient-Related Procedure-Related Device-Related Endoleaks

A table listing the events in the order in which they might be encountered during a procedure is also included, to serve as a cross-reference to the particular sections.

101

Condition Section Page

Preparation

1. Inability to flush sheath Device 107

2. Inadequate visualization of endovascular graft and/or anatomy Patient 102

Access

1. Unable to advance main body delivery system through vasculature Patient 102

Deployment

1. Presence of thrombus Patient 105

2. Thrombus noted in graft/sheath during deployment Procedure 105

3. Main body appears twisted Procedure 105

4. Improper contralateral limb orientation observed before deploymentof main body and contralateral limb

Patient 102

5. Improper contralateral limb orientation observed after deploymentof contralateral limb

Patient 103

6. Contralateral limb does not fully open Patient 103

7. Inability to cannulate the contralateral limb Patient 104

8. Difficulty in removing either trigger-wire release mechanism Device 107

9. Difficulty in removing proximal (gold) trigger-wire release mechanism Device 107

10. Zenith graft deployed too high, covering renal artery(ies) Procedure 106

11. Trigger-wire release mechanism detaching from trigger-wire Device 107

12. Handles detaching from Peel-Away sheath Device 107

Leg Deployment

1. Iliac leg too low in iliac Procedure 105

2. Appearance of kink or stenosis in deployed iliac leg graft Procedure 106

3. Iliac leg distal fixation site (minimum of 10 mm) does not appear achievable with planned device

Patient 105

4. Inadvertent internal iliac artery occlusion Procedure 106

Endoleaks

1. Endoleak observed at proximal or distal seal (Type I) Endoleak 108

2. Endoleak originating at an overlap joint (Type III) Endoleak 108

102

Troubleshooting – Patient-Related

Patient-Related

Condition Possible Cause Procedure

1. Unable to advance main body delivery system through vasculature

Angulation, tortuosity, calcification, or stenosis

1. Insert a Lunderquist Extra-Stiff wire guide (LES) to straighten vessel. Exercise caution if vessel is heavily calcified.

2. Angioplasty may be performed prior to insertion of device. Consider the contralateral iliac for insertion of main body.

note: switching the main body insertion site from the ipsilateral iliac to the contralateral iliac may alter the diameters and lengths of preselected iliac leg grafts needed for patient treatment.

Consider arterial dilatation or retroperitoneal access with or without conduit.

1. Access true lumen to assess proximal and distal extent of dissection.

2. Remove device and reevaluate device introduction options.

Access artery less than minimum diameter of 6.0 mm

Possible dissection

2. Inadequate visualization of endovascular graft and/or anatomy

Inadequate imaging equipment, non-compatible radiographic table, or patient obesity

Maintain image intensifier as close to patient’s abdomen as feasible.

Obtain appropriate C-arm, if available.

3. Improper contralateral limb orientation is observed before deployment of main body and contralateral limb (before sheath retraction)

Tortuosity, improper orientation during insertion

Withdraw device as a unit, reorient and reintroduce.

note: slight, judicious rotation of the delivery system is possible, but the entire system (positioner, sheath, cannula) must be rotated as a unit.

103

Patient-Related


4. Improper contralateral limb orientation is observed after deployment of contralateral limb (after sheath retraction)

Tortuosity, improper orientation during insertion; or improper manipulation during sheath retraction; or presence of thrombus or calcification

1. Attempt cannulation in present orientation.

2. If still unable to cannulate, refer to the procedure for Patient-Related condition #6, “Inability to cannulate the contralateral limb, ” page 104

5. Contralateral limb does not fully open

Narrow distal neck or presence of thrombus/calcification

If wire guide access can be gained through the contralateral limb, open the limb with an appropriate balloon.

If unable to cannulate, refer to the procedure for Patient-Related condition #6, “Inability to cannulate the contralateral limb, ” page 104.

104

Troubleshooting – Patient-Related

Patient-Related


6. Inability to cannulate the contralateral limb

Common iliac artery angulation, contralateral limb orientation (anterior or posterior), or presence of thrombus or calcification

• Complete deployment of the Low Profile main body, followed by deployment of ipsilateral iliac limb. Then, consider “up and over technique” or brachial approach (see below) to cannulate contralateral limb.

• If cannulation of the contralateral limb is unattainable, consider converting the bifurcated Low Profile graft to an aortouni-iliac configuration, using the Zenith Low Profile converter, iliac plug, and a femoral-to-femoral bypass procedure.

“Up and Over Technique”Place a wire guide and catheter "over the bifurcation" of the Low Profile graft. Advance wire guide down through the contralateral limb and capture the wire guide with a loop snare. Retrieve the wire guide through contralateral access. Establish proper wire guide position and proceed with deployment.

Brachial ApproachAccess may also be achieved via the left brachial artery. Advance the catheter and wire guide down the contralateral limb. Snare the wire guide. Retrieve the wire guide so that “through and through access” is attained. Establish proper wire guide position and proceed with deployment.

Troubleshooting – Procedure-Related

105

Patient-Related


7. Iliac artery distal fixation site of 10 mm or greater does not appear achievable with planned device

Angulation, tortuosity, or patient anatomy

Insert Zenith iliac leg graft (may need to consider embolization of internal iliac artery) as appropriate.

8. Presence of thrombus Inadequate imaging equipment, non-compatible radiographic table, or patient obesity

Use caution to avoid emboli.

Procedure-Related


1. Thrombus noted in the graft/sheath during deployment

Patient is not adequately heparinized

Check ACT; administer additional heparin, if necessary.

2. Main body appears twisted

Rotating the sheath independent of grey positioner during device preparation, or tortuosity

Align large radiopaque mark at the most proximal edge of the graft with the checkmark on the contralateral limb to orient position. Continue to check position while retracting sheath.

note: slight, judicious rotation of the delivery system is possible, but the entire system (positioner, sheath, cannula) must be rotated as a unit.

3. Iliac leg too low in iliac

Angulation, tortuosity, or patient anatomy

Consider increasing iliac leg overlap. Use alternative device, if available.

106

Troubleshooting – Procedure-Related

Procedure-Related


4. Zenith Low Profile graft deployed too high, covering renal artery(ies)

Improper placement of the Zenith Low Profile graft due to imaging errors or movement during deployment

Consider appropriate secondary renal intervention (e.g., angioplasty, renal stenting) if needed to preserve renal artery patency.

5. Appearance of kink or stenosis in deployed iliac leg graft

Tortuous iliacs, iliac stenosis, calcification, or thrombus

Consider additional intervention if necessary to maintain patency.

6. Inadvertent internal iliac artery occlusion

Inaccurate deployment If unilateral coverage, ensure contralateral internal iliac artery is patent.

If bilateral coverage, consider surgical intervention if needed to maintain adequate pelvic circulation.

107

Troubleshooting – Device-Related

device-Related


1. Inability to flush sheath

Side hole on sheath is covered

Pull sheath back in 1 - 2 mm increments to expose side hole. Flush.

2. Difficulty removing either trigger-wire release mechanism

Safety lock not completely removed

Completely remove safety lock.

Trigger-wire release mechanism was twisted during removal

Realign mechanism with handle.

3. Difficulty removing proximal (gold) trigger-wire release mechanism

Twisting of delivery system has put tension on the trigger-wires

Remove tension on trigger-wires and retighten the pin vise before removing trigger release mechanism

Tortuous anatomy prevents appropriate propagation of forces along the delivery system

Ensure a Lunderquist (LES) wire guide is in place and extends beyond the tip of the delivery system just short of the aortic arch.

Stabilize main body while removing trigger wire (e.g., inflate 12 mm balloon in contralateral limb). If necessary, a brachial approach using a loop snare to stabilize the delivery system while removing trigger wire may be used.

4. Trigger-wire release mechanism detaching from trigger-wire

Delivery system has put tension on the trigger-wire

Utilize clamps to grasp and remove wire.

5. Handles detaching from Peel-Away sheath

Improper deployment technique

Utilize clamps to grasp and remove Peel-Away sheath.

108

Troubleshooting – Endoleaks

endoleaks


1. Endoleak observed at proximal or distal seal (Type I)

Inadequate apposition of graft to vessel wall at fixation sites (landing zone)

Repeat use of molding balloon. Consider proximal or distal extensions, or additional intervention if necessary.

2. Endoleak originating at an overlap joint (Type III)

One stent overlap not achieved

Use an additional iliac leg to bridge the overlap sections of the components.

Tortuous iliac, iliac stenosis, calcification, or thrombus creating leak

Repeat use of molding balloon. Consider additional intervention if necessary.

CHAPTER 9Post-Procedure Patient Care & Follow-Up

9

112

Post-Procedure Patient Care & Follow-Up

Post-Procedure Patient Care and Follow-up

Follow-up Imaging Guidelines

the long-term performance of endovascular grafts has not yet been established. All patients should be advised that endovascular treatment requires lifelong, regular follow-up to assess their health and performance of their endovascular graft. Patients should be counseled on the importance of adhering to the follow-up schedule, both during the first year and at yearly intervals thereafter. Patients should be told that regular and consistent follow-up is a critical part of ensuring the ongoing safety and effectiveness of endovascular treatment of AAAs.

Physicians should evaluate patients on an individual basis and prescribe their follow-up relative to the needs and circumstances of the individual patient. The recommended imaging schedule is presented in table 9.1. This schedule was used in the pivotal trial and is recommended even in the absence of clinical symptoms (e.g., pain, numbness, weakness). Patients with specific clinical findings (e.g., endoleaks, enlarging aneurysms or changes in the structure or position of the stent graft) should receive follow-up at more frequent intervals.

Pre-op Intra-op 30-day 6-Month 12-Month4

CT Scan X 1 X3 X3 X3

Abdominal Device X-ray X X X

Angiography X2 X

1 Imaging should be performed within 6 months before the procedure.2 Required only to resolve any uncertainties in anatomical measurements necessary for graft sizing.3 Duplex ultrasound may be used for those patients experiencing renal failure or who are otherwise

unable to undergo contrast enhanced CT scan. 4 Yearly thereafter

table 9.1Recommended Minimum Imaging Schedule for Endograft Patients

113

Additional Surveillance and Treatment

Additional surveillance and possible treatment is recommended for:

• Aneurysms with Type I endoleak

• Aneurysms with Type III endoleak

• Aneurysm enlargement, > 5 mm of maximum diameter (regardless of endoleak status)

• Migration

• Inadequate seal length

• Limb thrombosis/occlusion or kinking

• Loss of fixation length or endograft migration

• Loss of device integrity

- Barb separation

- Stent fracture

- Kinking

- Relative component migration

Detection of any of these events calls for increased frequency of patient follow-up. Re-intervention may be required in some cases; general principles are discussed in Chapter 8, Troubleshooting.

Consideration for re-intervention or conversion to open repair should include the attending physician's assessment of an individual patient's co-morbidities, life expectancy, and the patient's personal choices. Patients should be counseled that subsequent re-interventions including catheter based and open surgical conversion are possible following endograft placement.

Components of Annual Imaging Follow-up

Annual imaging follow-up should include abdominal radiographs and both contrast and non-contrast CT examinations. If renal complications or other factors preclude the use of image contrast media, abdominal radiographs, non-contrast CT, and duplex ultrasound may be used. For each type of imaging, the information it provides and the suggested imaging protocol are described on page 117.

114


CT Imaging (Contrast and Non-Contrast)

The combination of contrast and non-contrast CT imaging provides information on:

• Aneurysm diameter change

• Endoleak

• Patency

• Tortuosity

• Progressive disease

• Fixation length

• Other morphological changes

CT Recommendations

• Film sets should include all sequential images at lowest possible slice thickness (≤3 mm). Do NOT perform large slice thickness (> 3 mm) and/or omit consecutive CT images/film sets, as it prevents precise anatomical and device comparisons over time.

• All images should include a scale for each film/image. Images should be arranged no smaller than 20:1 images on 14" x 17" sheets if film is used.

• Both non-contrast and contrast runs are required, with matching or corresponding table positions.

• Pre-contrast and contrast run slice thickness and interval must match.

• DO NOT change patient orientation or re-landmark patient between non-contrast and contrast runs.

115

Non-contrast and contrast enhanced baseline and follow-up imaging are important for optimal patient surveillance. It is important to follow acceptable imaging protocols during the CT exam. table 9.2 lists examples of acceptable imaging protocols.

Non-contrast Contrast

IV contrast No Yes

Acceptable machinesSpiral CT or

high performance MDCT capable of > 40 seconds

Spiral CT or high performance MDCT capable of > 40 seconds

Injection volume n/a Per institutional protocol

Injection rate n/a > 2.5 cc/sec

Injection mode n/a Power

Bolus timing n/aTest bolus: SmartPrep,C.A.R.E. or equivalent

Coverage – start Diaphragm 1 cm superior to celiac axis

Coverage – finish Proximal femur Profunda femoris origin

Collimation < 3 mm < 3 mm

Reconstruction2.5 mm throughout –

soft algorithm2.5 mm throughout –

soft algorithm

Axial DFOV 32 cm 32 cm

Post-injection runs None None

Abdominal Radiographs

The abdominal radiographs provide information on:

• Device integrity (stent breaks, kinking, barb separation, and relative component separation).

Recommendations for Abdominal Radiographs

The following views are required:

• Four films: supine-frontal (AP), lateral, 30 degree LPO, and 30 degree RPO views centered on umbilicus.

• Record the table-to-film distance and use the same distance at each subsequent examination.

Ensure entire device is captured on each single image format lengthwise. If there is any concern about the device integrity (e.g., kinking, stent breaks, barb separations, and relative component migration), it is recommended to use magnified views. the attending physician should evaluate films for device integrity (entire device length including components) using 2-4X magnification visual aid.

table 9.2Acceptable CT Imaging Protocols

116


Duplex Ultrasound

Ultrasound may be a less reliable and sensitive diagnostic method compared to CT. However, ultrasound imaging may be performed in place of contrast CT when patient factors preclude the use of image contrast media. In this circumstance, a non-contrast Ct should be performed to use in conjunction with the ultrasound.

Duplex ultrasound imaging may provide information on:

• Aneurysm diameter change

• Endoleak

• Patency

• Tortuosity

• Progressive disease

Recommendations for Ultrasound

When using ultrasound, a complete aortic duplex is to be videotaped for maximum aneurysm diameter, endoleaks, stent patency, and stenosis. Included on the videotape should be the following information as outlined below:

• Transverse and longitudinal imaging should be obtained from the level of the proximal aorta demonstrating mesenteric and renal arteries to the iliac bifurcations to determine if endoleaks are present utilizing color flow and color power angiography (if accessible).

• Spectral analysis confirmation should be performed for any suspected endoleaks.

• Transverse and longitudinal imaging of the maximum aneurysm should be obtained.

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MRI Safety and Compatibility

Non-clinical testing has demonstrated that the Zenith Low Profile AAA Endovascular Graft is MR Conditional. It can be scanned safely under the following conditions:

1.5 Tesla Systems:



• Maximum whole-body-averaged specific absorption rate (SAR) of 2.0 W/kg (normal operating mode) for 15 minutes of scanning.

In non-clinical testing, the Zenith Low Profile AAA Endovascular Graft produced a temperature rise of less than 1.7 °C at a maximum whole-body-averaged specific absorption rate (SAR) of 2.9 W/kg on the MR console display for 15 minutes of MR scanning in a 1.5 Tesla Magnetom, Siemens Medical Magnetom MR scanner. The maximum whole-body-averaged specific absorption rate (SAR) was 2.9 W/kg, which corresponds to a calorimetry measured value of 2.1 W/kg.

3.0 Tesla Systems:



• Maximum whole-body-averaged specific absorption rate (SAR) of 2.0 W/kg (normal operating mode) for 15 minutes of scanning

In non-clinical testing, the Zenith Low Profile AAA Endovascular Graft produced a temperature rise of less than 2.0 °C at a maximum whole-body-averaged specific absorption rate (SAR) of 3.0 W/kg on the MR console display for 15 minutes of MR scanning in a 3.0 Tesla, Excite, GE Healthcare MR scanner. The maximum whole-body-averaged specific absorption rate (SAR) was 3.0 W/kg, which corresponds to a calorimetry measured value of 2.8 W/kg.

MR image quality may be compromised if the area of interest is in the exact same area or within approximately 5 mm of the position of the Zenith Low Profile AAA Endovascular Graft as found during non-clinical testing using the sequence: T1-weighted, spin echo and Gradient echo pulse sequence in a 3.0 Tesla, Excite, GE Healthcare, with G3.0-052B Software, MR system with body radiofrequency coil. Therefore, it may be necessary to optimize MR imaging parameters for the presence of this metallic implant.

Cook recommends that the patient register the MR conditions disclosed in this section with the MedicAlert Foundation. The MedicAlert Foundation can be contacted in the following manners:

Mail: MedicAlert Foundation International 2323 Colorado Avenue Turlock, CA 95382

Phone: 888-633-4298 (toll free) 209-668-3333 from outside the US Fax: 209-669-2450

Web: www.medicalert.org

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Patient Tracking Information

The Zenith Low Profile AAA Endovascular Graft is packaged with a device tracking Form which the hospital staff is required to complete and forward to Cook Incorporated for the purposes of tracking all patients who receive the Zenith Low Profile AAA Endovascular Graft (as required by U.S. federal regulation).

Patient Identification Card

The Zenith Low Profile AAA Endovascular Graft is packaged with a Patient I.D. Card that should be completed and given to the patient. The completed Patient I.D. Card provides information concerning:

• Type of device implanted

• Date of implant

• Implanting physician

• Follow-up physician

• MRI information

Patients should be instructed to keep their Patient I.D. Card available at all times, to tell all of their health care providers that they have the graft, and to show them the Patient I.D. Card.

This patient has received a

MRI information on back side.

Cook Incorporated 750 Daniels Way Bloomington, IN

47404 U.S.A.812.339.2235

William Cook Europe ApSSandet 6, DK-4632

Bjaeverskov, Denmark+45 56 86 86 86

William Cook Australia Pty. Ltd.95 Brandl Street

Eight Mile Plains, QLD 4113 Australia

+61 7 38 41 11 88

Patient Name Implant Date

Implanting Facility Name

Implanting Physician

Implanting Physician Phone #

Follow-up Physician

Follow-up Physician Phone Number

Product Catalog #

Product Catalog #

Before MRI, you must show this card to your doctor who should assess potential risks and consider the MRI information in the device labeling on www.cookmedical.com. Because unforeseen variations in patient anatomy or scanners may increase risk, the MRI facility should allow for prompt intervention if necessary.

TAA

AAA

www.cookmedical.com

Cook Europe Shared Service Centre

Country Telephone E-MailAustria (+43) 1-795-67-121 [email protected] French (+32) 27-00-16-33 [email protected] Flemish (+32) 27-00-16-33 [email protected] (+45) 38487607 [email protected] (+353) 61-239240 [email protected] France (+33) 1-71-23-02-69 [email protected] (+49) 6950-072804 [email protected] (+36) 17779199 [email protected] (+39) 02-69-68-28-53 [email protected] (+31) 202-013-367 [email protected] (+47) 23-16-2968 [email protected] (+34) 91-2702691 [email protected] Switzerland French (+41) 44-8-009-609 [email protected] Italian (+41) 44-8-009-609 [email protected] German (+41) 44-8-009-609 [email protected] (+46) 85-876-94-68 [email protected] Kingdom (+44) 20-7365-4183 [email protected]

© COOK 2010 AI-BPHEU-AAALPPRM-EN-201004

AORTIC INTERVENTION

CRITICAL CARE ENDOSCOPY INTERVENTIONAL

RADIOLOGYLEAD

MANAGEMENTPERIPHERAL

INTERVENTION SURGERY UROLOGY WOMEN’S HEALTH

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