Kissing Balloon Technique for Infrapopliteal Angioplasty in Patients with Critical Limb Ischemia

Journal Pre-proof Kissing-balloon technique for infrapopliteal angioplasty in patients with critical limb ischemia Rodrigo Bruno Biagioni, MD, Felipe Nasser, MD Ph.D., Roberto da Costa Amaro Junior, MD, Marcelo Calil Burihan, MD, José Carlos Ingrund, MD, Nelson Wolosker, MD Ph.D. PII:

S0890-5096(20)30014-5

DOI:

https://doi.org/10.1016/j.avsg.2019.12.037

Reference:

AVSG 4849

To appear in:

Annals of Vascular Surgery

Received Date: 16 September 2019 Revised Date:

17 December 2019

Accepted Date: 30 December 2019

Please cite this article as: Biagioni RB, Nasser F, da Costa Amaro Junior R, Burihan MC, Ingrund JC, Wolosker N, Kissing-balloon technique for infrapopliteal angioplasty in patients with critical limb ischemia, Annals of Vascular Surgery (2020), doi: https://doi.org/10.1016/j.avsg.2019.12.037. This is a PDF file of an article that has undergone enhancements after acceptance, such as the addition of a cover page and metadata, and formatting for readability, but it is not yet the definitive version of record. This version will undergo additional copyediting, typesetting and review before it is published in its final form, but we are providing this version to give early visibility of the article. Please note that, during the production process, errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain. © 2020 Published by Elsevier Inc.

Kissing-balloon technique for infrapopliteal angioplasty in patients with critical

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limb ischemia

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Authors:

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Rodrigo Bruno Biagioni MD*

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Felipe Nasser MD Ph.D.**

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Roberto da Costa Amaro Junior MD *

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Marcelo Calil Burihan MD*

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José Carlos Ingrund MD*

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Nelson Wolosker MD Ph.D. ***

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* Santa Marcelina Hospital

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** Santa Marcelina Hospital and HIAE (Hospital Israelita Albert Einstein)

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*** HIAE (Hospital Israelita Albert Einstein)

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Author’s contact information:

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Rodrigo Bruno Biagioni

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Rua Canario, 917 apto 122 Moema São Paulo-SP Brazil Zip Code 04521-004

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Tel: +5511981871545

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E-mail: [email protected]

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This article has not been presented in any society, congress, etc.

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This article has not been published.

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Kissing-balloon technique for infrapopliteal angioplasty in patients with critical

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limb ischemia

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Abstract

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Objective: This study aimed to analyze the technical aspects and follow-up findings

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regarding patients with critical limb ischemia who underwent the kissing-balloon

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technique (KBT).

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Methods: Thirty patients (34 bifurcations) were enrolled in this retrospective analysis

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between September 2010 and February 2017. All patients were submitted to

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infrapopliteal intervention for critical limb ischemia. The KBT was the primary

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treatment in three situations: for cases with >70% stenosis of the main artery at located

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less than 1cm to the bifurcation, occlusion of one branch with greater than 50% stenosis

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of the contralateral branch, or greater than 50% bilateral stenosis. Stents were

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considered in cases of recoil greater than 30% or flow-limiting recoil and were used in 7

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of the 34 bifurcations (20.5%).

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Result: Primary patency at 30 days, 1 year, and 2 years was 100%, 68.1% and 68.1,

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respectively. Limb salvage rates at 30 days, 1 year and 2 years were 100%, 86.6%, and

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65.0%, respectively. Wound healing rates at 30 days, 6 months, 1 year, and 2 years were

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7.1%, 34.4%, 44.5%, and 68.7%, respectively. The bifurcations of the V-shape and T-

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shape groups were compared in terms of wound healing, primary patency, and limb

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salvage. No differences were observed in wound healing (P=0.268), primary patency

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(P=0.394), and limb salvage (P=0.755).

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Conclusions: The kissing-balloon technique is a feasible bifurcation approach for infrapopliteal angioplasties to maintain the patency of both branches after

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ballooning. The comparison between the anterior tibial artery and tibioperoneal trunk

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bifurcation and the peroneal artery and posterior tibial artery bifurcation revealed no

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difference in wound healing, primary patency, and limb salvage.

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Key words: infrapopliteal, kissing-balloon, critical limb ischemia, tibial arteries,

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angioplasty

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Introduction

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Endovascular treatment has been the primary approach for revascularization of

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the infrapopliteal (IP) arteries in the majority of the cases1–3. Although new devices have

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been developed to improve patency1,2, a recent review and meta-analysis did not

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confirm any real benefits of these new devices and suggested that angioplasty remains

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the preferred strategy for infrapatellar endovascular treatment1,2 with the use of

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provisional drug-eluting stents (DES) in cases of recoil or flow-limiting dissection1,2

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Treatment of more than one artery has been demonstrated to be an option to

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accelerate wound healing4,5. For angioplasty of more than one vessel, the endovascular

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approach of the bifurcation of the IP arteries with two balloons at the same time is often

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required (the kissing-balloon technique – KBT)8,9 to avoid plaque or carina shift,

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dissection of the ostium and residual stenosis of the side branch6–8.

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The KBT has been described for the treatment of bifurcations in the IP arteries in

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two cohorts of 7 and 8 patients6,9 and two cases reports10,11. Associated with these

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limited cohorts, no previous study analyzed the follow up of those patients submitted by

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that technique.

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The goal of this study was to analyze the results and follow-up findings regarding a cohort of 30 patients submitted to angioplasty with the KBT.

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Methods

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There were retrospectively studied thirty patients (34 bifurcations) submitted to

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a kissing-balloon technique for infrapopliteal angioplasty in patients with critical limb

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ischemia between September 2010 and February 2017. The local ethical committee

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approved the study, and all patients signed informed consent.

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The KBT was the primary treatment in three situations: for cases with >70%

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stenosis of the main artery at located less than 1cm to the bifurcation, occlusion of one

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branch with greater than 50% stenosis of the contralateral one, or greater than 50%

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bilateral stenosis. Gargiulo et al. study6 used these criteria. The technique was initially

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planned for 26 patients (29 of the 34 bifurcations). In 4 patients (5 bifurcations), the

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KBT was used after failed angioplasty of one or both branches using a standard

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technique.

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KBT technique was applied for the bifurcation of the anterior tibial artery (AT)

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and the tibioperoneal trunk (TPT) and for the bifurcation of the peroneal artery (PA) and

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the posterior tibial artery (PT). Among the 34 bifurcations treated, the technique was

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used for the TPT-AT bifurcation in 15 cases (group T-shape) and for the PT-PA in 19

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cases (group V-shape). In 4 cases, both bifurcations were treated.

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The mean age was 66.0±9.14 years, and 70% of the patients were male.

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Hypertension, diabetes, smoking, renal impairment, and coronary insufficiency were

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identified 93.3%, 73.3%, 43.3%, 20%, and 23.3% of the patients, respectively. Twenty-

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two patients (73.3%) had tissue loss. In 8 patients, the indication for the procedure was

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a pain at rest (Rutherford 4).

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All procedures were performed in an endovascular suite. The time from the

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start of anesthesia administration to completion of the angiogram and the volume of

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contrast media used in the procedure were recorded. The measurement of the stenosis of

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the arteries and the intensity of the radiation (in cGy) used in the angioplasty were

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processed and recorded using Philips ALLURA software (Philips Inc., Andover, MA).

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Images of the stenosis and occlusions were always made in two projections pre and post

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ballooning.

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Local anesthesia with lidocaine 1% was used in all cases. All patients received

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dual antiplatelet therapy (aspirin 100 mg/day + clopidogrel 75 mg/day) for at least two

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days before the procedure. In all cases, antegrade access to the common femoral artery

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(CFA) and/or superficial femoral artery (SFA) was preferred. Double access was

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required in 29 cases (the CFA and SFA in 24 patients and double SFA access in 5

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patients). In the double-access cases, a 4 French introducer sheath was used in 25 cases,

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a 5 French sheath was used in 28 cases, and a 6 French sheath was used in two. In one

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double-access procedure, sheathless access through the posterior tibial artery was used.

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In one approach, a single 8 French sheath was used in the CFA due to proximal stenosis

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of the SFA.

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After arterial puncture, 5000 U of intravenous heparin was administered. The

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intraluminal technique was primarily used for recanalization, and the subintimal

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technique was used excepted after the intraluminal failed. In most cases, a 0.018-inch

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hydrophilic guidewire (Terumo, Terumo Corporation, Tokyo, Japan) through a vertebral

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4Fr catheter was used. The guidewire was kept in each artery until balloon positioning.

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The balloon diameter was selected based on the diameter of the target IP artery, the

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anterior tibial artery, the peroneal artery, the posterior tibial artery, and the tibioperoneal

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trunk diameters ranged from 2 mm to 3.5 mm. The length of the balloon was selected to

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cover the entire stenotic/occluded site and to proximally cover at least 2 cm of the

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popliteal artery (in cases of the AT and TPT) or the TPT (in cases of the PA and PT).

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The proximal diameter of the double-D shape formed by the two balloons was

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calculated with the formula proposed by Mitsudo12: (diameter of the double-D shape of

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the main artery)2 = (balloon diameter of the distal artery)2 + (balloon diameter the other

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distal artery)2 (Figure 1). The balloon was inflated according to lower pressure sufficient

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to expand completely the center of the stenotic/occluded site. Balloons were maintained

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inflated for 3 minutes, and the pressure continuously corrected to the previous pressure

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value when a decrease is identified in the inflator. Both balloons were inflated and

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deflated at the same time. In cases of recoil or dissection, 0.5-1 mg of nitroglycerin was

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administered, and the balloons were inflated a second time and held for 5 minutes.

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Stents were used for recoil higher than 30% or/and in the presence of limited dissection.

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When stents were used, they were deployed at the same time as balloon inflation in the

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contralateral artery (Figure 1).

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The mean diameter of the balloons used was 2.87±0.22 French (ranging from

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2.5 to 4 French). The mean diameter of the double-D formed after the kissing-balloon

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technique was carried out in the popliteal artery was 4.14±0.39 French, and it was

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4.03±0.38 French in the TPT. After 3 minutes of inflation, greater than 30% recoil

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occurred in 5 bifurcations (3 T-shape and 2 V-shape cases). Flow-limiting dissection

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occurred in 2 cases (1 T-shape case and 1 V-shape case). Stents were used in 7 of the 34

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bifurcations (20.5%); 4 dedicated IP self-expandable stents of 4 mm in diameter (Xpert

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stent, Abbott Vascular Devices, Abbott Park, IL) and three coronary balloon-expandable

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stents (3 and 3.5 mm in diameter) were used. The indication for the use of each type of

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stent was based on the surgeon’s preference, but in general, coronary stents were used in

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specific diseased areas (especially in bifurcations), and self-expandable dedicated stents

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were used in broader diseased areas.

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Sixty-eight arteries were treated (34 bifurcations); arterial occlusions were

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identified in 52.8% of the cases, 70%-99% stenosis was observed in 23.5 %, 50%-69%

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stenosis was observed in 16.1%, and stenosis less than 50% was observed in 5.8% of

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the cases. Two arteries were treated in 28 patients, and three infrapopliteal arteries were

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treated in 12 patients using the same procedure. The mean lengths of the treated arteries

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were 100±92.1 mm, 96±104 mm, 66±51 mm, and 27±10 mm for the AT, PT, PA, and

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TPT, respectively. The mean radiation exposure was 201.9±94.6 cGy, and the mean

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volume of contrast media used was 101.2±23.7 mL. The mean time of the procedures

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was 66±31.9 minutes.

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Stents were used in 6 arteries of 5 patients (20%) at the ostium level. The

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technique of choice was the use of one stent only at the site of the identified problem (a

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spotting stent). Also, in one case, dissection was observed on both sides, and two stents

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were deployed with the kissing-stent technique (Figure 1).

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Retrograde access was used to achieve recanalization in 3 cases (through PT in

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two instances and AT in one). After retrograde recanalization, the KBT was performed

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after the “Rendez-vous technique”13 in two cases, and in one case, the KBT was applied

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with one balloon positioned distally through retrograde access and one balloon inserted

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through standard antegrade access.

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Data collection and follow-up. Data from the institution’s database and the

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angiographic images and videos of the procedures were analyzed. A specific protocol

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was used to collect the data. Patency and limb salvage were analyzed based on their

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definitions according to the Society of Vascular Surgery (SVS)14. The patients received

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follow-up examinations at an outpatient clinic within ten days of the procedure and

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between 7 and 30 days, depending on the wound and clinical status. The ankle-brachial

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index was calculated, and duplex scanning was performed in all patients at 1, 3, 6, and

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12 months and then annually. The wound care strategy was uniform for all patients.

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Debridement was performed at each outpatient visit, as indicated. Risk factor control

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and best medical treatment were applied in all patients

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Statistical Analysis: IBM SPSS 20.0 for Windows was used for the analysis

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(IBM Corp. Armonk, NY). Student’s t-test (normal distribution) and the Mann-Whitney

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U test (skewed distribution) were used to compare univariate continuous variables.

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Kaplan-Meier univariable analysis was used to estimate cumulative wound healing,

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limb salvage, primary patency, secondary patency, and overall survival. A log-rank test

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was used to compare survival curves. Cox regression (multivariable regression) was

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used to calculate risk ratios for the relevant clinical and technical aspects regarding

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wound healing, limb salvage, and primary patency. P values < .05 were considered to be

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statistically significant.

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Results

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The pre-intervention ABI (ankle-brachial index) was 0.41±0.13, and the post-

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intervention ABI was 0.82±0.10. Primary patency at 30 days, 1 year, and 2 years were

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100%, 68.1%, and 68.1, respectively. Secondary patency at 30 days, 1 year, and 2 years

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were 100%, 74.6 and 74.6, respectively. Limb salvage rates at 30 days, 1 year and 2

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years were 100%, 86.6%, and 65.0%, respectively. Overall survival rates were 92.8%,

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87.0% and 77.4%, respectively (Figure 2). One death occurred before 30 days, but it

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was not related to the procedure (10 days, heart attack). Wound healing rates at 30 days,

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6 months, 1 year, and 2 years were 7.1%, 34.4%, 44.5%, and 68.7%, respectively.

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The AT and TPT bifurcation and the PA and PT bifurcation were compared in

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terms of wound healing, primary patency, and limb salvage. No differences were

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observed in wound healing (P=0.268), primary patency (P=0.394), and limb salvage

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(P=0.755). Due to the small number of cases, primary patency could not be considered

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for analysis until 180 days (SE<10%) (Figure 3).

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The multivariable analysis identified diabetes mellitus as an independent factor

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of worse wound healing [OR: 0.310 (CI 95%: 0.100-0.963)]. No other risk factors or

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technical aspects were identified as statistically significant for wound healing, limb

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salvage, and primary patency (Table 1). The use of stents did not alter the studied

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outcomes (wound healing, primary patency, and limb salvage).

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Thrombolysis was required in 3 procedures. In 2 cases, thrombolysis was

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performed after determining the ease with which the guidewire advanced and

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identifying a compatible history of recent occlusion. In one case, thrombosis of the P3

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segment of the popliteal artery was observed, probably due to an error in heparin

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administration. In all cases, 10 mg of rTPA (recombinant tissue plasminogen activator)

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was administered through a multiperforated catheter, which was successful in all cases.

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In one patient with 100% occlusion of the three arteries, the AT occluded after inflation,

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but it was not rescued because of the poor quality of the distal portion of the artery and

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the good results observed for the treated PA and PT.

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Discussion

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The term “kissing-balloon” was initially used in the treatment of aortic

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bifurcation15, but the KBT was improved in coronary angioplasty. In coronary arteries,

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bifurcations are primarily treated by primary stenting using various techniques7,16. The

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question in coronary arteries is whether to use the KBT after stenting or to forego

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optimizing stent apposition to improve side branch access. Although this issue has not

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been resolved to date17–21, most articles have concluded that the KBT is only useful with

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the 2-stent technique17–20.

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In most of the cases, two access sites with 4 or 5 French sheaths, rather than one

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access site with a 6 or 7 French sheath, were used based on the team’s experience with

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superficial femoral artery access4. The use of two smaller access sites helped avoid

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misplacement of the guidewire during manipulation. In 3 cases, the KTB was executed

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on one side with retrograde access, accounting for 10% of the treated arteries and

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reflecting the complexity of the lesions.

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The results of the outcomes of this cohort are comparable to the effects of other

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articles. Considering the 1-year follow up, the primary patency of 68% was slightly

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higher (50.7%-66.1%)4,22–24. Limb salvage of 86.6% was comparable to other cohorts

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(68-97%)4,22–24, as well as the overall survival of 87% (32%-97%)4,22–24. The wound

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healing, besides a wide range observed in other studies (32-97%)4,24, was achieved in

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44.5% and could be considered a good result considering the severity of the lesions.

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In IP arteries, disease at the bifurcation is observed in 18% of cases25, and when

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the treatment of more than one artery is desired, the best strategy for the bifurcation

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approach should be considered. There is no formal guideline recommendation for the

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multivessel approach, but we considered in most cases, especially in patients with

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extensive wounds or with a high risk of amputation (e.g. heel, bone or articular capsule

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exposition)26.

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The design of the bifurcation is an important aspect of coronary arteries. A bifurcation

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is considered V-shaped when the offshoots of the arteries form an acute angle (less than

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70 degrees) or T-shaped when an angle greater than 70 degrees is formed. In the

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coronaries, the V shape is easier to cannulate, but the carinal shift often occurs.

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Cannulation of the lateral branch is more difficult with the T shape, but the carinal shift

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occurs less frequently19. The PTP and PA bifurcation is similar to a T shape, and the AT

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offshoots can be expected to be difficult to cannulate. Additionally, lack of an AT origin

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leads to failed cannulation, which may indicate that special coronary devices are not

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necessary for IP arteries as suggested by Colantonio et al. In V-shape bifurcations (the

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PT and PA), a shift occurred, and a stent was required to correct flow-limiting

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dissection27. Considering the outcomes after IP angioplasties, no differences were

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observed between the bifurcations in our cohort in terms of wound healing, primary

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patency, or limb salvage.

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In contrast to the coronary arteries, the use of stents in IP vessels has no

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consensus. In a meta-analysis by Jens et al., angioplasty with bailout stenting was the

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recommendation1. Drug-eluting stents with sirolimus or everolimus coating (DES) were

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studied in IP lesions and demonstrated better primary patency than plain angioplasty,

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but improvements in essential outcomes (wound healing or limb salvage) were not

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identified. Because of poor evidence level, DES is recommended for bailout stenting

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and not for primary use2. Specifically, for bifurcations in IP arteries, no consensus has

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been reached regarding the use of DESs28–30. Limited data are available regarding stent

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use in IP arteries. Silingardi et al. and Vassilev et al. described the use and results of

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specific coronary stents designed for bifurcations in IP arteries8,28. Spiliopoulos et al.

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and Werner et al., reported their experiences with the use of DESs in IP bifurcations

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with many different techniques25,30. The first authors used DESs for primary stenting,

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and Werner used DESs only after failure of plain angioplasty25,30.

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Considering the principle of bailout stenting in IP bifurcations, Gargiulo et al.

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described the KBT as the first strategy for bifurcations and reported the follow-ups of

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the patients in the study6. The indications for the technique were mainly the same as

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those in this study, and Gargiulo et al. reported 100% technical success and one case

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that required stent placement6. In the present cohort, the first strategy for bifurcations in

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selected cases and after standard angioplasty failed was the KBT. The use of stents was

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limited if recoil or flow-limiting dissection was identified; considering the high

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incidence of stent use (20%), these events were more frequent than in standard IP

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interventions4.

The limitations of the study are the retrospective analysis of the data and

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selective sampling with the possibility of more advanced disease in IP arteries among

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our patients. Another possible limitation is the comparisons of our outcomes with those

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in the literature and the lack of use of DES after recoiling or dissection, since in our

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institution, DESs were not allowed during the study period, and their use could improve

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the results in particular cases.

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Conclusions The kissing-balloon technique is a feasible bifurcation approach for

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infrapopliteal angioplasties to maintain the patency of both branches after ballooning.

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The results regarding wound healing, limb salvage, and primary patency are comparable

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to those in the usual infrapopliteal approach. The comparison between the anterior tibial

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artery and tibioperoneal trunk bifurcation and the peroneal artery and posterior tibial

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artery bifurcation revealed no difference in wound healing, primary patency, and limb

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salvage.

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Wound healing

Primary patency

Limb Salvage

1.014 (.941-1.094)

.944 (.824-1.081)

1.067 (.936-1.217

.895 (.14-2.924)

.210 (.033-1.327)

.482 (.065-3.569)

Hypertension

1.139 (.145-8.971)

.215 (.022-2.082)

21.615 (0-47.02)

Diabetes

.310 (.100-.963)*

1.419 (.158-12.766)

31.407 (.002-4951.28)

Smoking

.824 (.177-3.839)

.823 (.135-5.005)

.016 (0-50.551)

Renal impairment

.578 (.0184-1.813)

1.043 (.116-9.411)

1.814 (.164-20.058)

Coronary disease

2.100 (.0536-8.230)

.027 (0-95.527)

.033 (0-3004.86)

Stent

1.099 (.336-3.600)

.892 (.099-8.045)

2.141 (.228-15.917)

Retrograde access

.906 (.189-4.344)

.039 (0-398.506)

1.629 (.165-16.037)

Complete pedal arch

.617 (.190-2.002)

1.998 (.206-19.407)

.257 (.026-2.518)

Time of the procedure

1.011 (.984-1.039)

.995 (.959-1.033)

1.013 (.968-1.061)

Recoil

.727 (.157-3.372)

1.808 (.199-16.402)

1.135 (.099-13.062)

3.854 (.449-33.237)

.044 (.000-68.170)

.046 (.000-3.971)

Risk Factors Age Gender

Technical aspects

Disection

Test: Cox proportional hazards *statically significant data.

Table 1. Risk factors and technical aspects and the relationship with outcomes (wound healing, primary patency and limb salvage) of patients who underwent angioplasty with kissing-balloon technique. Figure 1. Angioplasty of the tibioperoneal trunk and anterior tibial artery with the kissing-balloon technique. A. Initial angiogram: 60% stenosis of the tibioperoneal trunk (TPT) and occlusion of the anterior tibial artery (AT). B. The kissing-balloon technique with two 3x150-mm balloons. Inflation at the same time. C. Residual stenosis of the TPT. D. A 3x150-mm balloon in the AT and a 3.5x20-mm stent in the TPT (inflation and deflation at the same time). E. Residual stenosis of the AT. F. Deployment of another 3.5x20-mm stent in the origin of the AT. Note the non-limiting residual dissection distal to the second stent deployed. G. Angiogram completion. Figure 2. Primary patency, secondary patency, limb salvage and overall survival among patients who underwent angioplasty of the infrapopliteal arteries with the kissingballoon technique. Figure 3. The primary patency of the anterior tibial artery (AT) and tibioperoneal trunk (TPT) bifurcation compared to the primary patency of the posterior tibial artery (PT) and peroneal artery (PA) bifurcation.