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Background: Paroxysmal atrial fibrillation (PAF) can be triggered by non-pulmonary vein foci, like the superior vena cava (SVC). The latter is correlated with improved result in terms of freedom from atrial tachycardias (ATs), when electrical isolation of this vessel utilizing radiofrequency energy (RF) is achieved. Objectives: Evaluate the clinical impact, in patients with PAF, of the SVC isolation (SVCi) in addition to ordinary pulmonary vein isolation (PVI) by means of the second-generation cryoballoon (CB) Methods: A total of 100 consecutive patients that underwent CB ablation for PAF were retrospectively selected. Fifty consecutive patients received PVI followed by SVCi by CB application, and the following 50 consecutive patients received standard PVI. All patients were followed 12 months. Results: The mean time to SVCi was 36.7 ± 29.0 s and temperature at SVC isolation was − 35 (− 18 to − 40) °C. Real-time recording (RTR) during SVCi was observed in 42 (84.0%) patients. At the end of 12 months of follow-up, freedom from ATs was achieved in 36 (72%) patients in the PVI only group and in 45 (90%) patients of the SVC and PV isolation group (Fisher's exact test p = 0.039, binary logistic regression: p = 0.027, OR = 0.28, 95%CI = 0.09–0.86). In survival analysis, SVC and PV isolation group was also associated with improved freedom from ATs (log-rank test: p = 0.017, Cox regression: p = 0.026, HR = 0.31, 95%CI = 0.11–0.87). Conclusion: Superior vena cava isolation with the CB in addition to PVI might improve freedom from ATs if compared to PVI alone at 1-year follow-up. [ABSTRACT FROM AUTHOR]

Purpose: The purpose of this study was to evaluate the feasibility and safety of superior vena cava (SVC) isolation in addition to standard pulmonary vein isolation (PVI) using the second-generation cryoballoon (CB) in patients with paroxysmal atrial fibrillation. Methods: Thirty-seven consecutive patients that underwent CB ablation for paroxysmal atrial fibrillation (PAF) were prospectively enrolled in our study. After PVI the SVC was mapped for potentials. If the SVC exhibited electrical activity, isolation was achieved performing a single 180-s balloon application. Results: Regarding SVC isolation, 180-s freeze in the SVC could be completed in 32 (86.4%) patients, and 5 patients had at least 120 s of freezing application (13.5%). Real-time recording during SVC isolation was observed in 30 (81.0%) patients. The mean time to isolation was 36.9 ± 28.7 s and the temperature at isolation was − 33 (− 15 to − 40) °C. No cases developed persistent phrenic nerve palsy (PNP) or any other complication. Conclusions: Superior vena cava isolation proved to be safe and feasible with the second generation cryoballoon in a prospective series of patients affected by PAF. [ABSTRACT FROM AUTHOR]

Objectives: It is imperative to understand the influence of second-generation cryoballoon (CB-2) and contact-force sensing radiofrequency ablation (CF-RF) on clinical outcomes in atrial fibrillation (AF). This updated meta-analysis of randomized controlled trials (RCTs) examined the efficacy and safety of CB-2 vs. CF-RF in patients with AF. Methods: RCTs on the use of CB-2 vs. CF-RF in patients with AF were included. The primary outcome was the recurrence of AF, and the key secondary outcomes included serious complications, acute pulmonary vein isolation (PVI), procedure duration, and fluoroscopy time. Results: A total of 261 articles were identified, and five studies with a total of 845 participants were included in the study. A total of 93% of participants had paroxysmal AF, 7% of participants had persistent AF, and none of participants had permanent AF. There were 499 participants in the CB-2 arm and 346 in the CF-RF arm. AF recurrence was comparable in the CB-2 group (30.3%) and the CF-RF group (29.2%) (OR = 0.93; 95%CI = 0.56–1.54; P = 0.79; I2 = 48%). There were no statistical differences in acute PVI (P = 0.92; I2 = 0%) and serious complications (P = 0.87; I2 = 47%) between the two groups. The procedure duration was shorter in the CB-2 group than in the CF-RF group (MD = − 13.39; 95%CI = − 15.58, − 7.19; P < 0.0001; I2 = 59%). Conclusion: Our study demonstrated that CB-2 and CF-RF had comparable recurrences of AF and similar incidences of serious complications in AF patients during the ablation process. [ABSTRACT FROM AUTHOR]

Introduction: It is unknown whether left atrial (LA) roof ablation combined with pulmonary vein isolation (PVI) using a second-generation cryoballoon provides additional benefit beyond that of PVI alone in patients with persistent atrial fibrillation (AF). The aim of this study was to compare arrhythmia recurrence rates after PVI alone versus PVI plus LA roof ablation. Methods and results: In this observational study, we analyzed 399 symptomatic patients with persistent AF treated with cryoballoon ablation. After univariate and multivariate analyses of the entire cohort, propensity score matching resulted in two groups of 86 patients each: (1) PVI plus LA roof ablation (PVI-plus group) and (2) PVI alone (PVI-only group). The primary endpoint was the first documented > 30-s arrhythmia recurrence after a 3-month blanking period. PVI was successful in all patients. A bidirectional conduction block across the LA roof was verified in 91.9% of patients in the PVI-plus group. During a median mid-term follow-up of 33 months, 21 patients (24.4%) in the PVI-plus group and 37 patients (43.0%) in the PVI-only group (P = 0.01) reached the primary endpoint. Multivariate analysis revealed AF history > 2 years (hazard ratio [HR] = 2.04, P < 0.01), LA area > 21 cm2 (HR = 2.36, P < 0.01), female sex (HR = 1.92, P = 0.02), and LA roof ablation (HR = 0.47, P < 0.01) as significant predictors of outcome. Conclusions: We observed a significant difference in arrhythmia recurrence rates between the two groups. LA roof ablation is an effective adjuvant treatment option that shows improved outcome compared with PVI alone. [ABSTRACT FROM AUTHOR]

Purpose: Cryoballoon (CB) technology in the context of anatomical pulmonary vein (PV) variants might hypothetically hamper successful PV isolation (PVI). Our aim was to assess the impact of a right middle PV (RMPV) in the setting of second-generation cryoballoon (CB advance-CB-A), on procedural parameters and on mid-term follow-up.Methods: Consecutive patients with AF presenting RMPV (RMPV+) at the pre-procedural computed tomography who underwent PVI by CB-A were enrolled. Comparison with propensity score-matched patients without RMPV (RMPV-) was performed. Acute procedural parameters and clinical follow-up were assessed.Results: A total of 240 patients (80 RMPV+) were included in the analysis. Twelve of 80 (15%) RMPV+ patients underwent a direct cryo-application in this variant and accomplished the isolation without phrenic nerve palsy, whereas in 25 of 80 (31%) RMPV+ patients, the RMPVs were not targeted directly nor indirectly (by co-occlusion during application at a major PV). At a median follow-up of 17.3 [interquartile range 11.3-26.5] months, there was no significant difference in AF-free survival between RMPV+ and RMPV- patients (78.8 vs 78.1%, P = 1.00), and the recurrence of atrial arrhythmias among patients with versus without an intentional or indirect cryo-application to the RMPV was not different (22 vs 20%, P = 1.00).Conclusions: Mid-term outcome after CB-A ablation did not differ between RMPV+ and RMPV- patients. Within RMPV+ patients, outcome was similar between those with versus without a cryo-application (either direct or indirect) to the additional vein. [ABSTRACT FROM AUTHOR]

Purpose: The purpose of the present study was to assess the long-term success rate of a single 3-min freeze per vein ablation strategy in the setting of pulmonary vein isolation (PVI) by means of second-generation cryoballoon (CB-A; Arctic Front Advance, Medtronic, Minneapolis, MN, USA) in a large cohort of patients.Methods: Three hundred and one patients with drug resistant atrial fibrillation (AF) having undergone PVI by means of CB-A using a single 3-min freeze per vein ablation strategy were included in the analysis.Results: Paroxysmal AF (PAF) was documented in 70.8% of the patients, while 29.2% presented with persistent AF (PersAF). The mean number of CB applications was 1.09 ± 0.3 in the left superior pulmonary vein (LSPV), 1.04 ± 0.2 in the left inferior pulmonary vein (LIPV), 1.12 ± 0.3 in the right superior pulmonary vein (RSPV), and 1.12 ± 0.3 in the right inferior pulmonary vein (RIPV). All PVs were successfully isolated with a 28-mm CB-A only. After a mean follow-up of 38.1 ± 7.5 months, 207 (68.8%) patients were free of atrial tachyarrhythmia (ATa) recurrences following a single procedure. Specifically, 72.8% of patients presenting with PAF and 59.1% of individuals with PersAF did not experience a recurrence.Conclusions: A single 3-min freeze per vein strategy is effective in treating AF on a long term follow-up of 38 months. Specifically, it can afford freedom from ATa recurrences in 72.8% of patients affected by PAF and 59.1% of patients initially presenting with PersAF after a single CB-A procedure. [ABSTRACT FROM AUTHOR]

Background: Pulmonary vein isolation (PVI) via catheter ablation is an approved therapy for patients with drug-refractory and symptomatic atrial fibrillation (AF). Furthermore, cryoballoon is now considered to be as effective as focal radiofrequency catheter ablation. This study examines the second-generation cryoballoon performance in a US multicenter review of real-world practices.Methods: By retrospective chart collections, the long-term efficacy and safety of the cryoballoon procedure were assessed in 15 US centers. All patients had a history of drug-refractory symptomatic paroxysmal AF and were treated with a cryoballoon PVI strategy at the index ablation.Results: Four hundred fifty-two patients were evaluated, and acute PVI was achieved in 99% of patients by cryoballoon catheter ablation. In 0.88% of patients (4/452), an additional focal ablation catheter was used to achieve acute PVI during the ablation procedure. Average procedure time was 128 (range 82 to 260) min, using an average of 17 (range 1 to 19) min of fluoroscopy. The most frequent adverse event was transient phrenic nerve injury (1.5%; 7/452 patients) which all resolved by the end of the procedure with no diaphragmatic dysfunction at discharge. There were no strokes, transient ischemic attacks, cardiac tamponade, atrioesophageal fistulas, or deaths during the study. At the 12-month efficacy endpoint, single-procedure success of freedom from atrial arrhythmia was 87% (393/452 patients).Conclusions: This real-world examination of the US practice demonstrates that second-generation cryoballoon ablation by PVI strategy is safe and effective among patients with paroxysmal AF. [ABSTRACT FROM AUTHOR]

Background: Catheter ablation is an established treatment option for patients with symptomatic atrial fibrillation (AF). The cornerstone of AF ablation is pulmonary vein isolation (PVI). The second-generation cryoballoon (2G-CB) has shown non-inferiority to radiofrequency (RF) ablation in paroxysmal AF in several trials. Growing evidence suggests that 2G-CB is also effective in patients with persistent AF (perAF). The aim of this study was to summarize and analyze available data on safety and mid-term (≥ 12 months) efficacy of PVI using 2G-CB in patients with perAF.Methods: We did a search in PubMed, Web of Science, Cochrane Library, and clinicaltrials.gov in December 2016 for studies of 2G-CB ablation for perAF. Studies reporting clinical success rates at a follow-up (FU) of ≥ 12 months were included. Success was defined as freedom from any atrial arrhythmia lasting > 30 s after an initial blanking period of 3 months. Acute success and complication rates were also assessed. Data were analyzed applying random-effects model.Results: A total of 917 patients from 11 studies meeting study inclusion criteria were analyzed. After a mean FU of 16.7 ± 3.0 months, 68.9% were free from recurrences [95% confidence interval (CI) 63.4–74.7%]. Overall acute success rate was 99.7% (95% CI 99.2–100%). Complications occurred in 5.5% (95% CI 2.4–9.6%). Vascular access complications were the most frequent 3.3% (95% CI 1.5–5.6%). The rate of phrenic nerve palsy/injury was 2.09% (95% CI 0.8–3.9%). No death, stroke or myocardial infarction was reported.Conclusion: The 2G-CB seems to be safe and effective in the treatment of perAF in the mid-term. [ABSTRACT FROM AUTHOR]

Background: The second-generation cryoballoon (cryoballoon Advance; CB-A) offers excellent outcomes on the mid-term follow-up. To the best of our knowledge, little is known regarding the long-term outcome after CB-A ablation for paroxysmal atrial fibrillation (AF).Objective: The aim of the study was to evaluate the freedom from recurrence of AF during a 3-year follow-up period, among consecutive patients having undergone pulmonary vein isolation (PVI) with the CB-A for paroxysmal AF (PAF).Methods: Consecutive patients with drug-resistant PAF who underwent PVI using CB-A as an index procedure formed the study group. Patients were evaluated with holter ECG recordings at 1, 3, 6 and 12 months and subsequent follow-up was biannual or based on the clinical status and at the physician discretion.Results: Seventy-six consecutive patients were enrolled. Of these patients, 6 were excluded because of lack of long-term follow-up. A total of 70 patients [44 male (63%); mean age 57.9 ± 14.5 years] with a mean follow-up of 38.0 ± 7.4 months were finally included. In total, 278 PVs were depicted on the pre-procedural CT scan. All PVs (100%) could be isolated with the CB-A only. The freedom from AF without antiarrhythmic drug (AADs) after a single procedure was 71.5% of patients at a mean 38.0 ± 7.4 months follow-up. If including repeat procedures, 80% of the patients were free from AF recurrence after 1.11 ± 0.32 procedures without AADs.Conclusion: The second-generation cryoballoon offers long-term freedom from PAF in 71.5% of treated patients with a single procedure without AADs on a 3-year follow-up period. [ABSTRACT FROM AUTHOR]

Purpose: Pressure waveform analysis has the potential for facilitated assessment of pulmonary vein occlusion during cryoballoon ablation for atrial fibrillation. Data on clinical outcomes using this method are lacking. We sought to validate through clinical outcomes the use of pressure waveform analysis as the primary method of determining pulmonary vein occlusion during cryoballoon ablation.Methods: A study was performed of 122 consecutive patients with atrial fibrillation (85% paroxysmal) undergoing cryoballoon ablation from May 2014 through July 2015 at a single institution using pressure waveform analysis as the primary method of assessing pulmonary vein occlusion.Results: Cryoballoon ablation, with additional segmental radiofrequency ablation in 13.7%, resulted in complete pulmonary vein isolation in 100% of patients. The single procedure freedom from recurrence of atrial arrhythmia beyond the initial 3-month post-ablation was 81.2% at a mean follow-up of 237 days. Recurrence of atrial arrhythmia within 3-month post-ablation was 11.1%, and predicted recurrence beyond 3 months. Repeat ablation was performed in 12.0% of patients.Conclusions: In the largest study to date on this topic and the only study to focus on clinical outcomes, pressure waveform analysis as the primary method of determining pulmonary vein occlusion in cryoballoon ablation of atrial fibrillation resulted in acute and long-term procedural success rates comparable to those reported with use of routine pulmonary venography. Controlled study is needed to confirm these findings and to determine if this technique affects variables such as procedure duration and radiation exposure. [ABSTRACT FROM AUTHOR]

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