evaluation of a novel bioabsorbable and non …

DOWNTOWN CAMPUS

INSTITUTE FOR CLINICAL RADIOLOGY

SECTION FOR INTERVENTIONAL RADIOLOGY

EVALUATION OF A NOVEL BIOABSORBABLE AND NON-SYNTHETIC

VASCULAR CLOSURE DEVICE: FISH IN DAILY ROUTINE

Marcus Treitl, MD; Maximilian F. Reiser, MD; Karla Maria Treitl, MD


INTERVENTIONAL RADIOLOGY

UNIVERSITY HOSPITALS OF MUNICH®

INTRODUCTION

Manual compression (MC) for closure of arterial access

15 – 20 min followed by 4- 6h immobilization

Reported Time to Hemostasis (TTH): 16 Min (FDA PMA filing P930038)*

Patient discomfort, maybe leading to noncompliance

Bleeding

Limited in obese patients and with coagulopathy or anticoagulation

Since mid 1990s development of vascular closure devices (VCDs)

Safely achieve complete hemostasis and closure of arteriotomy

Reduction of access related complications

Promise of improving workflow and patient comfort

* Koreny M, Riedmu ̈ller E, Nikfardjam M, et al. Arterial puncture closing devices compared with standard manual compression after cardiac catheterization: Systematic review and metaanaly- sis. JAMA

2004;291:350–357. Pompa JJ, Satler LF, Pichard AD, et al. Vascular complications after balloon and new device angioplasty. Circulation 1993;88:1569–1578. Lewis‐Carey MB, Kee ST. Complications of arterial closure devices. Tech Vasc Interv Radiol 2003;6:103–106.

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Interventional Radiology: Bioabsorbable non-synthetic vascular closure device FISH in daily routine – M. Treitl

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DRAWBACKS OF VCDs

Especially active VCDs introduce foreign bodies

Collagen or Synthetics like PGA, PEG, etc.

Typically induce inflammatory response: Cause for scarred groin (frequent re-puncture!)

Many Contraindications

Puncture of SFA, PFA, bifurcation, above IEA, multiple punctures required

Heavy arterial calcification

Small arterial caliber

Vessel tortuosity

Re-puncture within 30 days

New complications

Distal embolization

Deployment failure

Infection

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Active VCD, under development since early 2000s

Morris Innovative Inc., Bloomington, IN, USA

Intra- and extravascular sealing with t-shaped and wired piece of porcine SIS (small intestinal mucosa; Cook Biotech™)

Biologic material known from therapy of burns

Less inflammatory response

Resorbed within 90 days

Benefits

Less scarring of access site

Less limitations than other VCD

Puncture site location, access vessel size (≥ 3mm), calcification

Might be used as working sheath in some versions

Lower risk of distal embolization since made from one piece

FISH: FEMORAL INTRODUCER SHEATH & HEMOSTASIS

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FISH: OVERVIEW

FISH Control close

6 and 7F

Cuff stabilizer

FISH Combi close

5, 6, 7 and 8F

No Cuff stabilizer

How it works

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FISH: AVAILABLE DATA

FDA approval for use in diagnostic procedures (PMA)

Preliminary study in the US (2004 – 6)

297 patients

FISH: 139 diagnostic / 52 interventional pts.

MC: 67 diagnostic / 39 interventional pts.

Results

Mean time to hemostasis: 6 minutes

Mean time to mobilization: 2 hours

Technical success: 97.9% (4 device failures)

FISH: One severe bleeding (0.72%), 3 hematoma, 2 pseudoaneurysms

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Picture taken by FISH™ customer during non-trial cut-down procedure at Regional Medical Center of Acadiana.




AIM OF STUDY

To evaluate the

Feasibility

Efficacy

Safety

...of remodeled FISH Control close aVCD for routine use in

peripheral endovascular intervention

Pilot study

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PATIENT SELECTION

Prospective evaluation with ethics committee approval

Consecutive patients with indication for endovascular treatment of peripheral artery disease of the lower limb

Inclusion criteria:

Informed consent to participate in study

Procedure done with 6 or 7F access sheath

Access vessel diameter ≥ 3mm

Exclusion criteria:

Skin infection at access site

Other VCD than FISH recently implanted within last 30 days at planned access site

INR > 1.5

Denial of study participation

No influence of: thrombolysis, puncture site, BMI, anticoagulation, renal failure, stage of PAOD, sex, recent use of FISH at same access site

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STUDY ENDPOINTS

Primary efficacy endpoints

Time to hemostasis (TTH) in [sec]

time from sheath removal until stop of arterial bleeding

Time to ambulation (TTA) in [hours]

time from sheath removal until patient comfortable walking 10 m

Safety endpoints

Major complications

Require little to major therapy, prolonged hospital stay, maybe permanent sequelae

Minor complications

No or nominal therapy, no consequence; no prolonged hospital stay

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According to SIR guidelines for VCDs:

acceptable major complication rates for

• Manual compression: reported 0 – 3, acceptable 0-3

• VCD use: reported 0 – 7, accepatble 0 – 3%

Sheth RA et al for the Society of Interventional Radiology Standards of Practice Committee. J Vasc Interv Radiol 2014; 25:73–84

• Bleedings requiring transfusion • Pseudoaneurysm (PA) • Device embolization • Acute occlusion of the access

vessel • Access site infection

• Small hematomas




PROCEDURE AND FOLLOW UP

Procedure: always 5.000 IU Heparin i.v.

Antegrade or retrograde puncture of common femoral artery (CFA)

Implantation of FISH according to IFU

Physician has used > 20 devices prior to study

Short manual compression until hemostasis

Sterile wound dressing

Immobilization and sand sack for 1hr

In case of device failure / prolonged manual compression until hemostasis

Compression bandage for 24hrs / immobilization for 6hrs

Post-procedural follow-up the next day / prior to discharge / 6months:

Clinical inspection and palpation

Duplex ultrasound of access site and outflow (embolization of device?)

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PATIENT CHARACTERISTICS

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Patient count 132

Sex 88 male / 44 female

Mean age 71.5yrs (41 – 98yrs)

Mean BMI 28.2 (23 – 35)

Renal failure 32 (24.2%)

Critical limb ischemia 55 (41.7%)

Hypertension 59 (44.7%)

Thrombocytes 280.000

Mean INR 1.1

ASA or Clopidogrel alone 85%

Dual anti-platelet regimen 13%

Anticoagulation / Heparin 17%

Glycoprotein IIb/IIIA inhibitors 0




PROCEDURAL CHARACTERISTICS

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Patient count 132

Prior intervention same access site (no other VCD) 37 (28%)

Antegrade puncture 95 (72%)

6F 125 (94.7%)

Mean access vessel diameter 6.5 (3.8 – 8.2)

Visible calcification of punctured vessel 52 (39.4%)

Heavily calcified 8 (6.1%)

Thrombolysis with rt-PA during procedure 7 (5.3%)

Re-puncture after FISH

next day n = 6

within 12 months n = 12

Palpable scarring / resistance 0

Device displacement 0




RESULTS

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FISH Control Close Own pilot study

Patients (n) 132

Technical success 97% (n=128)

Device failures 1.5% (n=2)

TTH [sec] 45 [0 – 136]

TTA [hrs] 1.1 [1 – 4]

Major complications 2 PA (1.5%)

Minor complications 3 SH (2.3%)

Pain during implant n = 6 (4.5%)

Late device failures 0

+Sheth RA et al for the Society of Interventional Radiology Standards of Practice Committee. J Vasc Interv Radiol 2014; 25:73–84 *Kussmaul WG, Buchbinder M, Whitlow PL, et al. J Am Coll Cardiol 1995; 25:1685–1692. Applegate RJ, Grabarczyk MA, Little WC, et al. J Am Coll Cardiol 2002; 40:78–83. Chevalier B, Lancelin B, Koning R, et al. Cathet Cardiovasc Interv 2003; 58:285–291.

FISH Historical data

191

97.9%

2.1% (n=4)

360

2

1 Bl (0.72%)

3 SH / 2 PA (2.6%)

N/A

-

Manual compression (published data+)

-

-

-

960 – 1,500

-

0 – 3%

N/A

Sometimes observed

-

AngioSeal (published data*)

435 – 4,525

-

N/A

< 60

-

0.8 – 3.6%

7%

Often observed

N/A




IMMEDIATE RE-PUNCTURE 1 DAY AFTER FISH 6F Male, 40yrs

Treatment for right renal

artery occlusion 1 day before

6F FISH used for closure,

successfully

Acute re-occlusion the next day

re-puncture necessary

No intraluminal visible foreign

body

No device displacement

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FOLLOW-UP AFTER 6F FISH

Male, 78yrs

Repeat treatment for

multi-focal PAOD

Retrograde 6F

procedure and FISH

left CFA 12 months

ago

Angiographic follow-up

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6 Months 12 Months




CONCLUSION

FISH Control close device is

Easy-to-use, safe, and potent vascular closure device for interventional procedures

Mean TTH 45 sec

No device embolization / infection / displacement, even in case of failure!

comparable low major complication rate of 1.5%

In our observation no palpable / relevant scarring of access site

No device displacement / embolization in case of early re-puncture observed

Broader range of suitable vessel diameters starting from 3mm

Is not contraindicated in case of calcification (device failure may occur)

Remark:

Adequate preparation of puncture channel necessary (oozing possible)

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THANK YOU VERY MUCH FOR YOUR ATTENTION!

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CORRESPONDING AUTHOR:

Priv.-Doz. Dr. med. Marcus Treitl, MD, MBA

University Hospitals of Munich - Ludwig-Maximilians-University of Munich

Institute for Clinical Radiology

FON: +49 – 89 – 44005 – 9240

E-Mail: [email protected]

Internet: www.klinikum.uni-muenchen.de

www.radiologie-lmu.de

http://www.klinikum.uni-muenchen.de



http://www.radiologie-lmu.de



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