ClinicalImaging/mappingThe durability of pulmonary vein isolation using the visually guided laser balloon catheter: Multicenter results of pulmonary vein remapping studies
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.
References (24)
- et al.
Catheter ablation for atrial fibrillation: are results maintained at 5 years of follow-up?
J Am Coll Cardiol
(2011) - et al.
Five-year outcomes after segmental pulmonary vein isolation for paroxysmal atrial fibrillation
Am J Cardiol
(2009) - et al.
Impact of type of atrial fibrillation and repeat catheter ablation on long-term freedom from atrial fibrillation: results from a multicenter study
Heart Rhythm
(2009) - et al.
One-year clinical outcome after pulmonary vein isolation using the novel Endoscopic Ablation System in patients with paroxysmal atrial fibrillation
Heart Rhythm
(2011) - et al.
Balloon catheter ablation to treat paroxysmal atrial fibrillation: what is the level of pulmonary vein isolation?
Heart Rhythm
(2008) - et al.
Predictors of non-pulmonary vein ectopic beats initiating paroxysmal atrial fibrillation: implications for catheter ablation
J Am Coll Cardiol
(2005) - et al.
Spontaneous initiation of atrial fibrillation by ectopic beats originating in the pulmonary veins
N Engl J Med
(1998) - et al.
Initiation of atrial fibrillation by ectopic beats originating from the pulmonary veins: electrophysiological characteristics, pharmacological responses, and effects of radiofrequency ablation
Circulation
(1999) - et al.
Electrophysiological end point for catheter ablation of atrial fibrillation initiated from multiple pulmonary venous foci
Circulation
(2000) - et al.
Pulmonary vein isolation for paroxysmal and persistent atrial fibrillation
Circulation
(2002)
Persistence of pulmonary vein isolation after robotic remote-navigated ablation for atrial fibrillation and its relation to clinical outcome
J Cardiovasc Electrophysiol
Resumption of electrical conduction in previously isolated pulmonary veins: rationale for a different strategy?
Circulation
Cited by (125)
PV Isolation Using a Spherical Array PFA Catheter: Application Repetition and Lesion Durability (PULSE-EU Study)
2023, JACC: Clinical ElectrophysiologyValidation of lesion durability following pulmonary vein isolation using the new third-generation laser balloon catheter in patients with recurrent atrial fibrillation
2021, Journal of CardiologyCitation Excerpt :This model computed that the continuous ablation with 13 W generates comparable lesion depth and tissue temperatures as 8.5 W manual spot ablation. Theoretically, energy output of 8.5 W generates the shallower lesion than 12 W if manually exposed [15]. However, our results suggest that the resulting lower total energy deployed with the EAS3 is not associated with a higher rate of PV reconnections.
Impact of myocardial injury and inflammation due to ablation on the short-term and mid-term outcomes: Cryoballoon versus laser balloon ablation
2021, International Journal of CardiologyPulsed Field Ablation of Paroxysmal Atrial Fibrillation: 1-Year Outcomes of IMPULSE, PEFCAT, and PEFCAT II
2021, JACC: Clinical ElectrophysiologyCitation Excerpt :In this study, invasive remapping in a large number of patients (n = 110) at ∼2 to 3 months revealed that 84.8% of PVs (64.5% of patients) in the entire PFA cohort had durable PVI, with minimal differences between groups (Supplemental Table 6). Although these durability rates are comparable to the more favorable data reported with thermal ablation, these PFA results incorporated all patients over the course of PFA waveform or delivery evolution—including monophasic PFA, PFA-EO, and PFA-OW (15–22). But for the most advanced delivery, PFA-OW, the PVI durability rate of 96.0% for PVs (84.1% of patients) is substantially higher than reported previously (15–22).
Keeping it Simple: Balloon Devices for Atrial Fibrillation Ablation Therapy
2020, JACC: Clinical ElectrophysiologyCitation Excerpt :RF touch-up ablations are required in up to 13% of patients but become rare with user experience (100,106). Laser lesions provide good durability, with 86% of PVs remaining electrically isolated in patients undergoing a repeat interventional diagnostic procedure 3 months after the index procedure (107). In a pivotal multicenter randomized controlled study of patients with paroxysmal AF, PVI using the first-generation HeartLight laser balloon demonstrated noninferiority to RF ablation regarding safety and efficacy, resulting in device approval by the Food and Drug Administration (FDA) (108).
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.