Purpose. This multicenter, prospective registry evaluated the comparative safety and efficacy of left atrial appendage occlusion (LAAO) using the Watchman device (WD) and the Amplatzer Cardiac Plug (ACP) in patients with nonvalvular atrial fibrillation (NVAF) in real-world clinical practice in Russia. Methods. The study included data from 200 consecutive NVAF patients ( 66.8 ± 7.8 years, 44.5% female, median CHA2DS2VASc 4, median HAS-BLED 3) who had undergone LAAO implantation using WD ( n = 108 ) or ACP ( n = 92 ) from September 2015 to December 2017 in 5 medical centers in Russia. The primary safety endpoint was the procedure-related major adverse events, and the primary efficacy endpoint was the composite of thromboembolic events, device thrombosis, hemorrhagic events, and unexplained death during the 12-month follow-up. Results. Successful LAAO was performed in all 92 (100%) patients with ACP and 105 (97.2%) with WD ( p = 0.053 ). At 12 months, primary safety endpoint occurred in 6.5% of patients in the ACP group with no events in the WD group (6.5% vs. 0%, p = 0.008 ). During the 12-month follow-up, the primary efficacy endpoint has occurred in 8.3% of patients in the WD group ( n = 9 ) and 1.1% of patients in the ACP group ( n = 1 ) ( p = 0.016 ). Conclusions. In this multicenter prospective registry, LAA closure with the WD was associated with significantly higher thromboembolic events rate in NVAF patients. Patients, receiving the ACP, had more procedure-related major adverse events. However, further multicenter studies are necessary to evaluate these findings.

Objective: we aimed to assess the efficacy and safety of pulmonary vein (PV) cryoballoon ablation (CBA) in patients with a common trunk of the pulmonary veins (PVCT).Materials and methods: We performed a retrospective analysis of 596 primary PV CBA procedures using the second-generation cryoballoon (CB) Arctic Front Advance (28 mm). PV anatomy was visualized using direct LA angiography during high-frequency right ventricular pacing. We included forty-nine patients in whom a PVCT was identified. The one-step and sequential ablation approaches with simultaneous recording of biophysical and electrophysiological parameters were used for PVCT isolation. During CBA in the right PVs, high-output (2000 ms, 25 mA) pacing of the right phrenic nerve was performed via a electrode placed in the superior vena cava, and amplitude of diaphragm movement was monitored. In the case of impairment/loss of the diaphragm contraction ablation was immediately stopped.Results: 91.1% (543) patients had the normal drainage of PV. In 4 patients (0.67%), an additional right pulmonary vein was identified. The prevalence of PVCT was 8.2% (49 pts): a left common trunk (LCT) was observed in 43 patients (87.7%), a right common trunk (RCT) - in 6 patients (12.2%). Acute efficacy of PVCT isolation was 95.9% (47/79): in LCT - 95.3%, in RCT - 100%. The feasibility of the one-step antral isolation was 59.1% (n=29). During a median follow up of 12 (3-20) months, the clinical success rate of the procedure was 69.4%. A comparative analysis showed no significant difference between common trunk ablation approaches and clinical efficacy (p=0.346).Conclusion: CBA has been shown effective and safe for symptomatic AF patients with PVCT. The simultaneous and sequential ablation approaches can be performed with comparable efficacy.

Background Early recurrences of atrial arrhythmias (ERAA) after atrial fibrillation (AF) catheter ablation do not predict procedural failure. A well-demarcated homogeneous lesion delivered by cryoballoon is less arrhythmogenic, and the recommended three-months blanking period may not refer to cryoballoon ablation (CBA). Objective We aimed to evaluate the predictive role of ERAA after second-generation CBA using an implantable loop recorder. Methods This prospective observational study enrolled 100 patients (58 males, median age 58) with paroxysmal/persistent AF undergoing pulmonary vein (PV) CBA using second-generation cryoballoon with simultaneous ECG loop recorder implantation. The duration of follow-up was 12 months, with scheduled visits at 3, 6 and 12 months. Results 99 patients from 100 completed the 12-month follow-up period. ERAA occurred in 31.3 % of patients. 83.9 % of patients with ERAA also developed late recurrences. The 12-month freedom from AF in patients with ERAA was significantly lower than in those without ERAA (p < 0.0001). Non-paroxysmal AF and longer arrhythmia history were associated with increased risk of both early (HR 3.27; 95 % CI 1.32–8.08; p = 0.010 and HR 1.0147; 95 % CI 1.008–1.086; p = 0.015, respectively) and late recurrences (HR 3.89; 95 % CI 1.67–9.04; p = 0.002 and HR 1.0142; 95 % CI 1.007–1.078; p = 0.019, respectively) of AF. ERAA were another predictor for procedural failure (HR 15.2; 95 % CI (6.42–35.99; p = 0.019). Conclusions ERAA occurred in the third of the patients after PV second-generation CBA and are strongly associated with procedural failure. Longer duration of AF history and persistent AF are independent predictors of AF’s early and late recurrence.