Three-Year Clinical Outcome After 2nd-Generation Cryoballoon-Based Pulmonary Vein Isolation for the Treatment of Paroxysmal and Persistent Atrial Fibrillation　― A 2-Center Experience ―

Heeger, Christian-H.; Wißner, Erik; Knoll, M.D.; Knoop, B.; Reißmann, Bruno; Mathew, Shibu; Sohns, Christian; Lemeš, Christine; Maurer, Tilman; Santoro, Francesco; Riedl, Johannes; Inaba, Osamu; Fink, Thomas; Rottner, Laura; Wohlmuth, Peter; Goldmann, Britta; Ouyang, Feifan; Kuck, Karl‐Heinz; Metzner, Andreas

doi:10.1253/circj.cj-16-1334

Cited by 58 publications

(29 citation statements)

References 28 publications

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“…Although CB ablation could be an alternative strategy for catheter ablation of persistent AF, the reported single procedure outcome is limited as compared to paroxysmal AF. 15 All these data highlight the importance of a proximal CB position during the application. The proximal-seal technique was initially proposed by Su et al to avoid deep CB positioning.…”

Section: Preprocedural and Intraprocedural Predictors Of Pnimentioning

confidence: 86%

“…It is plausible that advanced atrial remodeling might be associated with a higher incidence of PNI. Although CB ablation could be an alternative strategy for catheter ablation of persistent AF, the reported single procedure outcome is limited as compared to paroxysmal AF . All these data highlight the importance of a proximal CB position during the application.…”

Section: Discussionmentioning

confidence: 99%

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Characteristics of Phrenic Nerve Injury During Pulmonary Vein Isolation Using a 28‐mm Second‐Generation Cryoballoon and Short Freeze Strategy

Miyazaki

Kajiyama

Watanabe

et al. 2018

JAHA

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BackgroundThe reported incidence of phrenic nerve injury (PNI) varies owing to different definitions, balloon generations, balloon size, freezing regimen, and protective maneuvers. We evaluated the incidence, predictors, and outcome of PNI during cryoballoon pulmonary vein isolation in a large population.Methods and ResultsFive hundred fifty atrial fibrillation patients underwent pulmonary vein isolation using one 28‐mm second‐generation cryoballoon and single 3‐minute freeze strategy under diaphragmatic compound motor action potential (CMAP) monitoring. A total of 34 (6.2%) patients experienced PNI during the right superior and inferior pulmonary vein ablation in 30 and 4 patients, respectively. Applications were interrupted using double‐stop techniques after 136 [104–158] second applications, and a pulmonary vein isolation was already achieved in all but one case. The baseline CMAP amplitude and timing of deflation (CMAP def) were 0.75±0.30 and 0.17±0.17 mV, respectively. Persistent atrial fibrillation, larger right superior pulmonary vein ostia, and deeper balloon positions were associated with higher incidences of PNI. The CMAP def predicted a PNI recovery delay, and the best cutoff value for predicting PNI recovery by the next day was 0.20 mV (sensitivity 57.1%, specificity 100%). Among 6 patients undergoing second procedures 8.5 (6.7–15.0) months later, the right superior pulmonary vein was durable in 3 with >120 second applications. Despite active balloon deflation, no significant pulmonary vein stenosis was observed in 15 right superior pulmonary veins evaluated 6 (5–9) months later. No patients had symptoms, and the PNI recovered 1 day and 1 month postprocedure in 21 and 4 patients, respectively.Conclusions PNI resulting from cryoballoon ablation was reversible. The double‐stop technique is safe, and immediate active deflation following a CMAP decrease appears to be essential for faster PNI recovery.

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Section: Preprocedural and Intraprocedural Predictors Of Pnimentioning

confidence: 86%

Section: Discussionmentioning

confidence: 99%

Characteristics of Phrenic Nerve Injury During Pulmonary Vein Isolation Using a 28‐mm Second‐Generation Cryoballoon and Short Freeze Strategy

Miyazaki

Kajiyama

Watanabe

et al. 2018

JAHA

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“…The second‐generation CB (Arctic Front Advance, Medtronic Inc., Minneapolis, MN, USA) (CB2) has several advantages over the first generation in terms of design, enabling better cooling properties, and larger lesion formation . Although there were several studies about 1‐year follow‐up results of CB2, few studies have reported its mid‐ and long‐term satisfactory efficacy like RF ablation . However, all those studies with extended follow‐up data included limited numbers of patients.…”

Section: Introductionmentioning

confidence: 99%

Long‐term outcomes of pulmonary vein isolation using second‐generation cryoballoon during atrial fibrillation ablation

Canpolat

Koçyiğit²,

Yalçın

et al. 2019

Pacing Clinical Electrophis

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Background: Currently available second-generation cryoballoon (CB2) is accepted as an effective and safe tool for pulmonary vein isolation (PVI). Although much more data exist about 1-year outcomes of CB2 ablation, data on long-term outcomes are scarce. Objective:We aimed to assess the long-term outcomes of PVI using CB2 in a large-scale symptomatic atrial fibrillation (AF) population at our tertiary referral center. Methods:In this nonrandomized prospective observational study, a total of 486 patients with paroxysmal (71%) or persistent (29%) AF who underwent index PVI using CB2 at our hospital between January 2013 and June 2017 were enrolled. Atrial tachyarrhythmia (ATa)-free survival was defined as the absence of AF, atrial flutter, or atrial tachycardia recurrence ≥30 s following a 3 months blanking period. Predictors of recurrence were evaluated by univariate and multivariate Cox proportional hazards regression models. Results:Acute procedural success rate was 99.8% (1898( /1902. Mean procedural and fluoroscopy time were 64.9 ± 9.2 and 12.1 ± 2.6, respectively. At median 39 (interquartile range: 26-56) months follow-up, ATa-free survival was 78.6% after a single procedure (280/345 [81.2%] for paroxysmal AF vs. 102/141 [72.3%] for persistent AF, P = .019) and 84.4% after a mean 1.48 ± 0.42 ablations. Cox regression analysis showed that left atrium diameter, duration of AF history, and early ATa recurrence were found as the independent predictors of late recurrence.Phrenic nerve palsy was observed in 17 (3.5%) patients. Conclusions:CB2-based PVI is effective to maintain sinus rhythm in a significant proportion of paroxysmal and persistent AF patients with an acceptable complication rate at long-term follow-up. K E Y W O R D S atrial fibrillation, complication, cryoballoon, recurrence 1 INTRODUCTION As pulmonary vein (PV) isolation (PVI) is accepted as the cornerstone of all atrial fibrillation (AF) ablation procedures, recent expert consen-sus document recommends to isolate PVs at first either using point-bypoint radiofrequency (RF) or cryoballoon (CB) ablation in all patients, including paroxysmal and nonparoxysmal AF. 1 CB technology has been shown to be as effective as RF technique for AF ablation. 2 910

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“…Balloon-based ablation systems have been developed to possibly solve these limitations, reduce procedure time and increase the safety and efficacy of PVI. 2,3 The visually guided laser balloon ablation (VGLB) system (HeartLight, CardioFocus, Marlborough, MA, USA) is a balloon-based ablation system that utilizes laser energy for PVI. 4,5 The 1st-generation laser balloon (LB1) showed high…”

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confidence: 99%

Second-Generation Visually Guided Laser Balloon Ablation System for Pulmonary Vein Isolation: Learning Curve, Safety and Efficacy　― The MERLIN Registry ―

Heeger

Phan

Meyer‐Saraei

et al. 2019

Circ J

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Background: Radiofrequency (RF)-based pulmonary vein isolation (PVI) results in a favorable clinical outcome, although its complexity demands a long learning curve. Balloon-based systems have been developed to possibly solve these limitations. The 2nd-generation laser balloon (LB2) offers optimized features for improved tissue contact and visibility. We determined the safety, efficacy and learning curve of the LB2 for PVI. Methods and Results: A total of 45 consecutive patients (89% persistent AF) were prospectively enrolled and divided into 3 groups (T1, T2, T3) of n=15 patients per group. All patients underwent PVI by 2 operators using the LB2. The operators were experienced in RF and cryothermal procedures, but not in laser ablations. A total of 174/177 PVs (98%) were successfully isolated. The median procedure time significantly declined from 132 (114, 158) to 119 (102, 127) and 91 (86, 105) min in T1-3, respectively (P=0.0009). Similarly, the median fluoroscopy time significantly decreased from T1 to T3 (22 (17, 27) vs. 21 (16, 24) vs. 13 (10, 17) min, respectively, P=0.045). Adverse events occurred in 6.7%, with a trend towards a lower complication rate with increasing experience. Conclusions: The LB2 was safe and effective for PVI, even for operators without any previous experience in laser balloon-based PVI. Procedure time, left atrial dwelling time and fluoroscopy time decreased after a learning curve of 15 cases.

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Three-Year Clinical Outcome After 2nd-Generation Cryoballoon-Based Pulmonary Vein Isolation for the Treatment of Paroxysmal and Persistent Atrial Fibrillation　― A 2-Center Experience ―

Abstract: CB2-based PVI resulted in a 60.2% single-procedure and a 78.6% multiple-procedure success rate after 3 years. Repeat procedures demonstrated a high rate of durable PVI.

Cited by 58 publications

References 28 publications

Characteristics of Phrenic Nerve Injury During Pulmonary Vein Isolation Using a 28‐mm Second‐Generation Cryoballoon and Short Freeze Strategy

Characteristics of Phrenic Nerve Injury During Pulmonary Vein Isolation Using a 28‐mm Second‐Generation Cryoballoon and Short Freeze Strategy

Long‐term outcomes of pulmonary vein isolation using second‐generation cryoballoon during atrial fibrillation ablation

Second-Generation Visually Guided Laser Balloon Ablation System for Pulmonary Vein Isolation: Learning Curve, Safety and Efficacy　― The MERLIN Registry ―

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Three-Year Clinical Outcome After 2nd-Generation Cryoballoon-Based Pulmonary Vein Isolation for the Treatment of Paroxysmal and Persistent Atrial Fibrillation ― A 2-Center Experience ―

Abstract: CB2-based PVI resulted in a 60.2% single-procedure and a 78.6% multiple-procedure success rate after 3 years. Repeat procedures demonstrated a high rate of durable PVI.

Cited by 58 publications

References 28 publications

Characteristics of Phrenic Nerve Injury During Pulmonary Vein Isolation Using a 28‐mm Second‐Generation Cryoballoon and Short Freeze Strategy

Characteristics of Phrenic Nerve Injury During Pulmonary Vein Isolation Using a 28‐mm Second‐Generation Cryoballoon and Short Freeze Strategy

Long‐term outcomes of pulmonary vein isolation using second‐generation cryoballoon during atrial fibrillation ablation

Second-Generation Visually Guided Laser Balloon Ablation System for Pulmonary Vein Isolation: Learning Curve, Safety and Efficacy ― The MERLIN Registry ―

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Three-Year Clinical Outcome After 2nd-Generation Cryoballoon-Based Pulmonary Vein Isolation for the Treatment of Paroxysmal and Persistent Atrial Fibrillation　― A 2-Center Experience ―

Second-Generation Visually Guided Laser Balloon Ablation System for Pulmonary Vein Isolation: Learning Curve, Safety and Efficacy　― The MERLIN Registry ―