a new stenting technique for bifurcation lesions a nine-patient case series

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A new stenting technique for bifurcation lesions: A nine- patient case series K. Ocal Karabay, MD (1), Bayram Bagirtan, MD (2), Vedat Aytekin, MD (3) 1- Department of Cardiology, Kadikoy Florence Nightingale Hospital, Istanbul, Turkey 2- Department of Cardiology, Avrupa Safak Hospital, Istanbul, Turkey 3- Department of Cardiology, Sisli Florence Nightingale Hospital, Istanbul, Turkey Short title: K-TAP stenting Conflicts of Interest: None Corresponding Author: K. Ocal Karabay, MD No. 61, Bagdat CD. Kiziltoprak, Kadikoy, Istanbul, Turkey 0902164500303 Catheterization and Cardiovascular Interventions This article has been accepted for publication and undergone full peer review but has not been through the copyediting, typesetting, pagination and proofreading process which may lead to differences between this version and the Version of Record. Please cite this article as doi: 10.1002/ccd.24824

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Page 1: A new stenting technique for bifurcation lesions a nine-patient case series

A new stenting technique for bifurcation lesions: A nine-

patient case series

K. Ocal Karabay, MD (1), Bayram Bagirtan, MD (2), Vedat Aytekin,

MD (3)

1- Department of Cardiology, Kadikoy Florence Nightingale Hospital,

Istanbul, Turkey

2- Department of Cardiology, Avrupa Safak Hospital, Istanbul, Turkey

3- Department of Cardiology, Sisli Florence Nightingale Hospital,

Istanbul, Turkey

Short title: K-TAP stenting

Conflicts of Interest: None

Corresponding Author:

K. Ocal Karabay, MD

No. 61, Bagdat CD. Kiziltoprak,

Kadikoy, Istanbul, Turkey 0902164500303

Catheterization and Cardiovascular Interventions

This article has been accepted for publication and undergone full peer review but has not beenthrough the copyediting, typesetting, pagination and proofreading process which may lead todifferences between this version and the Version of Record. Please cite this article asdoi: 10.1002/ccd.24824

Page 2: A new stenting technique for bifurcation lesions a nine-patient case series

Abstract

Aims: This study describes and reports preliminary outcomes using K-

TAP (kissing T-stenting and small protrusion), a novel modification of

traditional T-stenting and small protrusion (TAP).

Methods and Results: Nine patients who were treated with K-TAP

between May 2008 and February 2012 at two hospitals were

retrospectively included in this study. The primary endpoints were

angiographic success, procedural success, and the composite 30-day and

long-term occurrences of major adverse cardiac events (MACEs), which

consisted of death, coronary artery bypass graft surgery, repeated

percutaneous coronary intervention of the target vessel, and non-Q-wave

and Q-wave myocardial infarctions. Data were obtained from the review

of institutional databases, folder auditing, a telephone survey of the

patients, and the review of angiograms. Angiographic success and

procedural success were achieved in all patients. The mean fluoroscopy

time for the total procedure was 24.1 minutes (range 20-28). No

complications occurred during the procedures. The MACE rate during the

mean follow-up period of 102 weeks (range 22-196 weeks) was 0%.

Conclusions: K-TAP, a new coronary bifurcation stenting method, has

favorable angiographic and procedural success rates and a low early post-

procedure MACE rate. Further studies are needed to evaluate the clinical

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efficacy of the K-TAP method.

Keywords: coronary bifurcation, angiography, drug eluting stent, bare

metal stent

Introduction

Coronary bifurcation lesions (CBLs) are associated with a greater risk of

complications, a lower rate of angiographic success, longer

hospitalization, higher cost, and increased angiographic and clinical

restenosis rates as compared to non-bifurcation lesions (1,2). Although

the restenosis rate and the event rate for the main vessel (MV) have been

reduced by the use of drug-eluting stents (DES), the side branch (SB)

event rate and restenosis rate, especially in the ostium, have remained

high due to incomplete coverage by stents (3). Because clinical outcomes

of one-stent and two-stent strategies have been comparable in the

previous studies, it is not surprising that the most commonly selected

approach for bifurcation lesions has been provisional side branch

stenting, i.e., stenting the MV and, only if required, followed by

placement of another stent in the SB (4). However, up to 28% of cases

eventually will need to be treated with two stents, one each in the MV

and SB, due to the suboptimal results in the SB ostium (5). This high

crossover rate to two-stent techniques emphasizes the need for an

optimal, safe, and easy two-stent technique. Various two-stent

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techniques, including the T-stenting and small protrusion technique (6)

(TAP-stenting), T-stenting (7), Y-stenting (8), crush stenting (9), culotte

stenting (10), and simultaneous kissing stenting (SKS) (11) have all been

introduced in an attempt to provide better SB ostial coverage and to

improve outcomes. No technique has yet demonstrated superiority in

terms of death and target vessel revascularization (12).

The purpose of the TAP technique is to create a new carina consisting of

one stent layer. The TAP technique provides full coverage of bifurcated

lesions (6). The position of the SB stent is very important in creating the

new carina, and TAP technique is not recommended if its exact position

cannot be determined due to low radio-opacity, obesity, or inadequate

fluoroscopy equipment (6). To prevent malpositioning of the new carina

in the MV, we implemented a variation of the TAP technique: the

kissing-inflation of T-stenting and small protrusion (K-TAP) technique,

in which the SB stent is inflated simultaneously with the balloon in the

MV to prevent excessive protrusion of the SB stent into the MV.

This case series aims to describe the K-TAP technique as well as the first

clinical results achieved with this technique.

Methods

We retrospectively evaluated nine patients who were treated with K-TAP

as an initial or bailout strategy between May 2008 and February 2012 at

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two hospitals. Data were obtained from the review of institutional

databases, folder auditing, a telephone survey of the patients, and review

of angiograms. The institutional ethics committee approved the study

protocol. This case series includes data from the first nine patients to

undergo this new technique without exclusion

Technique:

The K-TAP technique is illustrated in Figure 1-2. This technique can be

used as initial approach or as a bailout strategy for failed single stent

strategy. The steps are as follows:

1) MV and SB are wired (1A, 2A). 2) Pre-dilatation is performed in the

MV (1B, 2B). 3) The stent is placed in the MV (1C-D, 2C). 4) The jailed

wire is removed and the SB re-wired. The SB ostium is pre-dilated with

ballooning only in the SB or with kissing inflation of the MV and SB

(Fig. 1E, 2D). 5) An un-inflated compliant balloon is placed in the MV

immediately distal to the origin of the SB (Fig. 1F). 6) The SB stent and

the MV balloon are retracted proximally until their proximal markers

become almost the same level. 7) The balloon and the stent are inflated

simultaneously with the appropriate pressures (kissing inflation) (Fig. 1G,

2E). 8) Kissing balloon inflation using the same balloon at high pressure

is performed in the same place (Fig. 1H) 9) The balloons are pulled back

one to two millimeters, and the inflation of the kissing balloon to a high

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pressure is repeated while the distal part of the SB balloon is still in the

SB (Fig. 1I, 2F). If needed, additional kissing balloon dilatation with non-

compliant balloons can be repeated.

Medications

All patients received intra-arterial unfractionated heparin (10,000 IU)

after placement of the femoral artery sheet. Five patients (cases 5, 6, 7, 8,

and 9) received aspirin and clopidogrel (300 mg loading dose and 75 mg

daily dosage) five days before the stenting procedure. Patients with acute

myocardial infarction (cases 1, 2, 3, and 4) received aspirin (500 mg) and

clopidogrel (600 mg loading dosage) just prior to the stenting procedure.

Tirofiban was given immediately before stenting and was continued for

24 hr after the procedure. Clopidogrel (75 mg/day) was prescribed to all

patients for at least one year. All patients were advised to continue taking

aspirin indefinitely.

Endpoints and Definitions

The angiographic success, the procedural success, and the composite 30-

day and long-term incidences of major adverse cardiac events (MACEs),

which consisted of death, non-Q- and Q-wave myocardial infarctions, and

target lesion revascularization (TLR), were collected. MACEs were

recorded based on clinical examination or phone contact for all patients.

Coronary angiography was performed only in the presence of typical

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symptoms or signs of ischemia in noninvasive tests as per hospital

protocol.

Angiographic success was defined as a final stenosis diameter of 30%

with good TIMI 3 flow in both the main and side branches. Procedural

success was described as angiographic success without any cardiac event

(death, emergency CABG, repeat PCI of the target vessel, and non-Q-

and Q-wave myocardial infarctions) before discharge.

The diagnosis of myocardial infarction was based on the development of

new Q-waves of more than 0.04 sec in two or more contiguous leads,

with an increase in the creatine kinase level to more than three times the

upper limit of the normal range along with an elevated MB isoform level.

Non-Q-wave infarction was diagnosed as an increase in the creatine

kinase level to more than three times the upper limit of the normal range

and an elevated MB isoform level without the development of new Q-

waves. Patients who had initially presented with myocardial infarction

had to have suffered symptomatic recurrent ST-segment elevation along

with the following to be diagnosed with recurrent acute myocardial

infarction: 1) an increase in the levels of CK and/or cardiac troponins

and/or 2) angiographic verification of target vessel occlusion. TLR was

defined as any repeat PCI or surgery due to restenosis (stenosis diameter

≥50%) within the stent or in the 5 mm segment distal or proximal to the

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stent resulting in symptoms or objective signs of ischemia.

The Medina classification was used to classify the bifurcation lesions

(13). In this classification, the first number represents the MV just

proximal to the bifurcation, the second number represents the main vessel

immediately distal to the bifurcation, and the last digit represents the SB.

A value of “1” signifies the presence of a >50% lesion, and a value of “0”

indicates the absence of such a lesion.

Results

Baseline clinical characteristics for all patients are presented in Table 1.

Eight of the nine patients were male, with a mean age among all patients

of 55 years (range 37-69 years). The risk factors for cardiovascular

disease (CVD) were; diabetes mellitus (n= 3), hypertension (n= 5),

hyperlipidemia (n= 6), smoking (n= 7), and family history of CVD (n=

2). Patients were diagnosed with acute anterior myocardial infarction

(n=4), stable angina pectoris (n=4), or acute coronary syndrome (n=1) at

the time of hospital admission. All lesions were of the Medina 1,1,1 type.

Angiographic success and procedural success were achieved in all

patients. Patients with acute myocardial infarction (n=5) were discharged

on the fourth day, and the remaining patients (n=4) were discharged on

the second day in good condition. The left anterior descending artery was

the main vessel in all cases, and pre-dilatation in the MV and SB was

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always performed. The stents in the MVs were either sirolimus-eluting

stents (SES) (n=5) or everolimus-eluting stents (ELS) (n=4). The SBs

received bare metal stents (BMS) (n=3), ELS (n=5), or SES (n=1). The

average diameter of the stents in the main vessels was 3.2±0.3 mm (range

3.0-3.5), and the mean stent length in the main vessel was 26.3 ± 4.8 mm

(range 18-32). The average side branch stent diameter was 2.7 ± 0.4 mm

(range 3.0-2.25), and the mean side branch stent length was 16.3 ± 4.3.

The mean inflation pressures were 15.5 atm (range 14-18) and 14.8 atm

(range 14-16) in the MV and SB respectively. No difficulty was

experienced in advancing the balloon and stent to the SB in any case. All

of the cases were finalized with kissing balloon inflation. The mean

fluoroscopy time for the entire procedure was 24.1 minutes (range 20-

28).

Four patients (cases 5, 7, 8, 9) were still taking clopidogrel at the time of

publication. Three patients (cases 1, 3, 6) were prescribed dual anti-

platelet therapy for 52 weeks, case 2 for 152 weeks, and case 4 for 137

weeks. The mean follow-up time was 102 weeks (range 22-196 weeks).

During the procedure, no complications occurred. Patients were typically

evaluated at 1 month, 3 months, 6 months, and then annually following

the procedure. None of the patients had MACEs during the short- or long-

term follow-up periods. Only one of the patients (case 6) underwent

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coronary angiography due to chest pain 1.5 years after the index

procedure, which revealed open LAD and D2 stents without any stenosis.

All patients were still free of cardiac symptoms at the time of publication.

Discussion

The results from this case series suggest that K-TAP is a safe procedure

that overcomes many of the limitations of other stenting techniques.

Approximately 15% of percutaneous revascularization procedures (PCIs)

are currently performed to treat CBLs (14). The correct treatment

approach for CBLs has been a topic of debate among cardiologists

worldwide for over 20 years (15).

Several trials addressing provisional or routine two-stent techniques have

been conducted. All of these studies failed to show any advantage of

routine two-stent implantation in both the MV and SB over provisional

SB stenting in terms of clinical or angiographic end-points (16-19).

Moreover, in a BBC ONE trial, the provisional arm performed

significantly better than the arms treated with routine two-stent

techniques (crush or culotte) as measured by death, myocardial infarction,

and target vessel failure at 9 months (8.0% vs. 15.2%, P<0.05) (19).

Based on these results, the current recommendation is to avoid stenting

the SB if possible (20). However, it is not uncommon to place a stent in

the SB because of inadequate results in the SB (5).

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Among the various two-stent techniques, provisional t-stenting (PTS) is

the most commonly used strategy in daily practice (20). However,

Colombo (3) and Pan (18) et al reported 20% and 15% SB restenosis

rates, respectively, and restenosis was linked to inadequate coverage of

the SB ostium by the stent, particularly in the presence of an acute angle

between the MV and the SB (21-23). The other two-stent techniques

include Y-stenting (8), crush stenting (9), culotte stenting (10), and SKS

(11). The disadvantages of these techniques include the numerous re-

crosses needed in the culotte technique, the problematic resolution of

inflow dissection in the SKS technique, concerns with thrombosis after

using the crush technique due to the presence of three layers of stents,

problems with the final kissing with the crush technique, and a lack of

opportunity to use a provisional technique with both the SKS and crush

techniques (23).

Burzotta et al described the TAP technique in 2007 (6). In this technique,

1) the stent is placed in the MV, 2) the kissing balloon is inflated in the

MV and SB, 3) a non-inflated balloon is placed in the stent while the

position of stent is adjusted to cover the SB ostium, 4) the SB stent is

inflated while the balloon in the MV is kept un-inflated, 5) the balloon in

the stent is pulled back, and 6) kissing balloon is performed by

simultaneously inflating the stent’s balloon and the MV balloon. This

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technique results in the protrusion of the stent strut into the MV and

creates a new single-layer carina, in contrast to carinas composed of two

or three stent layers, as occurs with the culotte and crush techniques,

respectively. In two previous studies, the MACEs rates for TAP were

9.6% with two stent thromboses at nine months in 61 patients (6) and

5.3% at one year in 19 patients (24). The MACE rates were comparable

between the one- and two-stent arms at the one-year follow-up (24). In

other words, placing another stent into the SB with TAP did not increase

the MACE rate at one year.

In 2009, Al Rashdan et al presented the results of a new bifurcation

technique, a carina modification technique (CMT) (23) that was the same

as the TAP technique (25), in 156 patients with a 48-month follow-up

period. The procedural success rate was 99%, and the target vessel

revascularization (TVR) rate was 5.3% (23).

All of these findings suggest that TAP is a good option among two-stent

strategies. However, the diameter and behavior of the un-inflated balloon

in the MV, the skill of the operator and any unintentional movement of

the stent or the balloon could theoretically affect the position of the SB

stent in the MV and, thus, the position and shape of the new carina. Thus,

the new carina might be too far into the lumen, and the inflation of the

kissing balloon after stent implantation might not be adequate to correct

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this problem. This protrusion might create an obstruction or result in

turbulence that affects the direction of blood flow. Whether these

concerns have any role in clinical practice is unknown. Our technique is a

variation of the TAP technique that was designed to address these

concerns. The main difference is that K-TAP places the balloon in the

MV at the level of the bifurcation, and the balloon is retracted along with

the stent in the SB. In addition, both balloons are simultaneously inflated.

Our aim was to reduce the effects of any unintentionally misplaced struts

within the MV during the inflation of the SB stent in order to prevent

displacement of the new carina in the MV. Immediately after the

implantation of the stent, we finished with kissing balloon inflation, as in

TAP. However, after retracting the balloons, we repeated kissing balloon

inflation in the proximal part of the MV stent while the distal part of the

SB balloon was in the ostium of the SB to prevent any strut distortion in

the proximal parts of the SB and MB stents. This last kissing inflation is

different from that used in the proximal optimization technique, in which

a shorter and wider balloon is inflated only in the MV stent not in the SB,

but the aim is the same.

K-TAP is a variation of TAP but is also similar to the technique described

by Ferenc et al (26). In their technique, after MV stenting, they place an

un-inflated balloon inside the MV. However, in their technique, half of

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the first millimeter of the SB is retracted into the MV, and they first

inflate the stent and immediately afterwards inflate the balloon in the

MV. However, in our technique, the SB stent is retracted more into the

MV until the proximal markers of the stent and the balloon come into

contact, and the implantation in the SB is performed simultaneously with

the inflation of the balloon in the MV. This more stent protrusion, which

was limited by the kissing balloon inflation, in K-TAP technique

precludes any geographical gap between the SB ostium and the MV.

K-TAP can be used as an initial or a bailout strategy. In this study,

angiographic and procedural successes were achieved in all patients

without any complications. The pre-dilatation of the stent strut in the MV

is an important step to prevent any difficulty in advancing the stent into

the SB, as in TAP. Furthermore, choosing appropriate-sized stents and

using high pressure during inflation are important.

This is a small, retrospective case study. The re-stenosis rate would have

been high with routine angiography. The stents in the study were SES,

ELS or BMS (only in the SB), and it is unclear whether this technique

would yield the same results with other stents. Furthermore, the size of

the guiding catheter has to be taken into account when selecting the stent

and the balloons; our experience was limited to SES, ELS and low-profile

balloon catheters on a 6F guiding catheter.

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Conclusion

This study demonstrates the angiographic success, procedural success and

short-term safety of the K-TAP technique in a select group of patients. A

larger, prospective study designed to demonstrate efficacy is required to

establish the long-term outcomes of this new procedure.

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Giubilato S, Niccoli G, Giammarinaro M, Porto I, Leone AM, Mongiardo

R, Mazzari MA, Schiavoni G, Crea F. Provisional TAP-stenting strategy

to treat bifurcated lesions with drug-eluting stents: one-year clinical

results of a prospective registry. J Invasive Cardiol. 2009; 21:532-7.

25- Burzotta F, Trani C.TAP stenting: an intuitive and practical technique

to treat bifurcated lesions in the hands of different operators. Catheter

Cardiovasc Interv. 2010; 75:979-80; author reply 981.

26- Ferenc M, Gick M, Kienzle RP, Bestehorn HP, Werner KD, Comberg

T, Kuebler P, Buttner HJ, Neumann FJ. Randomized trial on routine vs.

provisional T-stenting in the treatment of de novo coronary bifurcation

lesions. Eur Heart J. 2008; 29:2859–2867.

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Catheterization and Cardiovascular Interventions

Catheterization and Cardiovascular Interventions

Page 21: A new stenting technique for bifurcation lesions a nine-patient case series

Fig 1. A: Two wires in the main vessel and side branch. B: Pre-dilatation

in the main vessel. C: The stent position in the main vessel D: The stent

covering the side branch ostium. E: Pre-dilatation of the side branch

ostium. F: Position of an un-inflated balloon in the main vessel. G: The

side branch stent implantation with K-TAP technique. H: Kissing balloon

inflation. I: The final kissing balloon inflatation. J: The position of the

stents.

Fig 2. K-TAP used as a bailout approach. A: A bifurcation lesion

(Medina 1,1,1) in the left cranial view. B: Pre-dilatation in the main

vessel C: Total occlusion of the side branch. D: Kissing balloon inflation

in both the main vessel and the side branch. E: A stent is placed in the

side branch with the K-TAP technique and kissing balloon inflation at

same place afterward. F: The balloon of the stent and the balloon in the

side branch are retracted one to two millimeters, and the kissing balloon

is inflated. G: Optimal results in the apical view. I: The stent in the side

branch protrudes into the main vessel.

Table 1. Clinical demographic features of the patients.

F: Female, M: Male; MI: acute anterior myocardial infarction; ACS:

acute coronary syndrome; SAP: stable angina pectoris; DAP: dual anti-

platelet therapy consisting of aspirin and clopidogrel.

Page 21 of 24

Catheterization and Cardiovascular Interventions

Catheterization and Cardiovascular Interventions

Page 22: A new stenting technique for bifurcation lesions a nine-patient case series

Case

1

Case

2

Case

3

Case

4

Case

5

Case

6

Case

7

Case

8

Case

9

Age 61 56 40 37 45 69 66 66 55

Sex M M M M M M M F M

Diabetes

mellitus

- - - - - + - + +

Hypertension + - - - + + + + -

Hyperlipidemia - + + - + + + - +

Smoking + + + + + + + - +

Familiy History - + - - + - - - -

Clinical

Presentation

MI MI MI MI ACS SAP SAP SAP SAP

Duration of

DAP(wks)

52 152 52 137 cont. 52 cont. cont. cont.

Follow up

(wks)

160 196 104 139 46 104 104 50 22

Page 22 of 24

Catheterization and Cardiovascular Interventions

Catheterization and Cardiovascular Interventions

Page 23: A new stenting technique for bifurcation lesions a nine-patient case series

Fig 1. A: Two wires in the main vessel and side branch. B: Pre-dilatation in the main vessel. C: The stent position in the main vessel D: The stent covering the side branch ostium. E: Pre-dilatation of the side branch ostium. F: Position of an un-inflated balloon in the main vessel. G: The side branch stent implantation with K-TAP technique. H: Kissing balloon inflation. I: The final kissing balloon inflatation. J: The position of the

stents. 160x128mm (300 x 300 DPI)

Page 23 of 24

Catheterization and Cardiovascular Interventions

Catheterization and Cardiovascular Interventions

Page 24: A new stenting technique for bifurcation lesions a nine-patient case series

K-TAP used as a bailout approach. A: A bifurcation lesion (Medina 1,1,1) in the left cranial view. B: Pre-dilatation in the main vessel C: Total occlusion of the side branch. D: Kissing balloon inflation in both the main vessel and the side branch. E: A stent is placed in the side branch with the K-TAP technique and

kissing balloon inflation at same place afterward. F: The balloon of the stent and the balloon in the side branch are retracted one to two millimeters, and the kissing balloon is inflated. G: Optimal results in the

apical view. I: The stent in the side branch protrudes into the main vessel. 254x190mm (300 x 300 DPI)

Page 24 of 24

Catheterization and Cardiovascular Interventions

Catheterization and Cardiovascular Interventions