Elsevier

Heart Rhythm

Volume 9, Issue 6, June 2012, Pages 919-925
Heart Rhythm

Clinical
Imaging/mapping
The durability of pulmonary vein isolation using the visually guided laser balloon catheter: Multicenter results of pulmonary vein remapping studies

https://doi.org/10.1016/j.hrthm.2012.01.019Get rights and content

Background

The visually guided laser ablation (VGLA) catheter is a compliant, variable-diameter balloon that delivers laser energy around the pulmonary vein (PV) ostium under real-time endoscopic visualization. While acute PV isolation has been shown to be feasible, limited data exist regarding the durability of isolation.

Objective

We sought to determine the durability of PV isolation following ablation using the balloon-based VGLA catheter.

Methods

The VGLA catheter was evaluated in patients with paroxysmal atrial fibrillation (3 sites, 10 operators). Following transseptal puncture, the VGLA catheter was advanced through a 12-F deflectable sheath and inflated at the target PV ostium. Under endoscopic guidance, the 30° aiming arc was maneuvered around the PV and laser energy was delivered to ablate tissue in a contiguous/overlapping manner. At ∼3 months, all patients returned for a PV remapping procedure.

Results

In 56 patients, 202 of 206 PVs (98%) were acutely isolated. At 105 ± 44 (mean ± SD) days, 52 patients returned for PV remapping at which time 162 of 189 PVs (86%) remained isolated and 32 of 52 patients (62%) had all PVs still isolated. On comparing the operators performing <10 vs ≥10 procedures, the durable PV isolation rate and the percentage of patients with all PVs isolated were found to be 73% vs 89% (P = .011) and 57% vs 66% (P = .746), respectively. After 2 procedures and 12.0 ± 1.9 months of follow-up, the drug-free rate of freedom from atrial fibrillation was 71.2%.

Conclusions

In this multicenter, multioperator experience, VGLA resulted in a very high rate of durable PV isolation with a clinical efficacy similar to that of radiofrequency ablation.

Introduction

Pulmonary vein (PV) isolation is the mainstay of catheter-based therapy for patients with drug refractory, paroxysmal atrial fibrillation (AF).1, 2, 3, 4 Although acute isolation of the PVs can be achieved in virtually all cases, chronic clinical efficacy is limited by a high rate of electrical reconnections.5, 6, 7, 8, 9, 10, 11, 12 This may, in part, be due to the difficulty in manipulating an ablation catheter around the PVs and delivering contiguous and transmural lesions.

Recently, a balloon-based visually guided laser ablation (VGLA) catheter has been designed to facilitate PV isolation.13, 14, 15, 16, 17 The VGLA catheter has (1) real-time endoscopic visualization, (2) a maneuverable aiming arc, and (3) laser energy that is delivered at the site of the aiming arc to ablate tissue. The first-generation balloon was noncompliant and had a large 90−120° aiming/ablative arc. This often resulted in a suboptimal area of balloon/tissue contact, and the large ablative arc limited energy delivery because of concerns of thrombus formation from ablation in areas with overlapping blood.13 The second-generation VGLA catheter has a compliant balloon with an expandable variable diameter that was designed to accommodate PVs with varied anatomies and sizes. This new balloon together with a smaller 30° aiming/ablative arc was intended to improve the area of balloon/tissue contact and allow more optimal energy delivery.

With adequate lesion overlap, we and others have demonstrated in both preclinical and clinical cases that it is possible to place circumferential and contiguous lesions, which ultimately translated to a high rate of acute PV isolation.14, 15, 16, 17 In addition, in a small, single-center clinical experience, we demonstrated that this translated to durable PV isolation when patients were routinely remapped 3 months after the index ablation procedure.14 In order to determine the generalizability of this observation, we now report on the multicenter, multioperator experience of the durability of PV isolation achieved by using the VGLA catheter, as assessed by PV remapping procedures at 3 months postablation.

Section snippets

Methods

The study consisted of 56 patients enrolled in 2 European studies at 3 clinical sites: (1) Homolka Hospital, Prague, Czech Republic; (2) Institute for Clinical and Experimental Medicine, Prague, Czech Republic; and (3) San Camillo-Forlanini Hospital, Catholic University of Sacred Heart, Rome, Italy. A total of 10 primary operators participated in these procedures. The studies were approved by the human ethics committees at the participating institutions. The authors had full access to and take

Patient demographics

The mean age of the 56 patient cohort was 57.1 ± 9.7 years (range 31−75 years), and 40 (71%) of the patients were men. The median duration of paroxysmal AF was 4.0 years (2.0–7.0; Q1−Q3). Coronary artery disease was present in 6 (11%) patients and hypertension in 27 (40%) patients.

Initial ablation procedure characteristics

In the 56 patients, a total of 206 PVs were targeted (Table 1). Acute PV isolation was achieved in 202 of 206 PVs (98.1%) and was independent of PV type (Table 2). Complete electrical isolation of all PVs was achieved

Discussion

The goal of catheter-based therapy for paroxysmal AF is durable PV isolation. While acute PV isolation is achieved in virtually all cases, chronic efficacy is often limited by the resumption of conduction between the PVs and the left atrium.5, 6, 7, 8, 9, 10, 11, 12 In this multicenter experience, we have shown that a high rate of acute and durable PV isolation can be achieved by using the VGLA catheter. Acute PV isolation was achieved in 98% of targeted PVs. At ∼3 months, 86% of PVs were

Conclusions

A high rate of acute PV isolation can be achieved with the compliant, variable-diameter, visually guided laser balloon alone, without the need for adjunctive spot ablation catheters. This high rate of acute PV isolation is durable, with 86% of PVs remaining isolated at 3 months. However, the clinical efficacy appears similar to that of radiofrequency ablation. Multicenter, randomized trials are needed to properly compare the efficacy of both treatment modalities.

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    This study was supported by CardioFocus, Inc. Dr Neuzil, Dr Kautzner, Dr Dello Russo, Dr Tondo, and Dr Reddy received research grant support from CardioFocus, Inc.

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