Cryoballoon pulmonary vein ablation and left atrial appendage closure combined procedure: A long-term follow-up analysis

Abstract

BACKGROUND The combined left atrial appendage closure (LAAC) and cryoenergy pulmonary vein isolation (PVI) procedure has been proven safe and effective in managing stroke in patients with nonvalvular atrial fibrillation (AF), although most data refer to procedures performed using radiofrequency as the main energy source. OBJECTIVE The purpose of this study was to evaluate long-term follow-up of patients with AF undergoing concomitant LAAC and cryoenergy PVI. METHODS Patients undergoing LAAC and cryoballoon PVI at our institution were enrolled. At 3, 6, and 24 months from the index procedure, we determined the atrial arrhythmia recurrence rate, the extent of LAAC, and the rate of cerebrovascular/bleeding events. RESULTS Forty-nine patients (mean age 69 6 8 years; 32/49 (67%) men; CHA 2 DS 2-VASc score 2.8 6 1.2; HAS-BLED score 3 6 1) with a guideline-recommended LAAC indication were included. Acute PVI and complete LAAC were achieved in 100% of patients. All patients completed at least 24 months of follow-up. At 8 weeks and 6 months, complete or satisfactory (,5 mm leak) LAAC rates were achieved in 40 (82%) and 9 (18%) and in 42 (86%) and 7 (14%) of patients, respectively. The overall freedom from atrial arrhythmia rate at 24 months was 29 (60%), and 45 (92%) of patients were off antithrombotic drugs. The observed annualized stroke and bleeding rates were 1% and 2%, respectively, a 71% and 60% risk reduction in comparison to event rates predicted from CHA 2 DS 2-VASc and HAS-BLED scores. CONCLUSION Concomitant cryoballoon ablation and LAAC procedures appear safe and effective at long-term follow-up, with high antithrombotic drug withdrawal rates at 24 months.

Amplatzer left atrial appendage closure: Single versus combined procedures

“…Previous studies of LAAC combined with electrophysiological and structural interventions have shown that in the long term 5,6,21 . This was also the case for a combined approach of concomitant LAAC and AF ablation, which was not only feasible and safe, but also substantially reduced stroke and bleeding events as compared to anticipated rates predicted by the CHA 2 DS 2 ‐VASc and HAS‐BLED scores.…”

A left atrial appendage closure combined procedure review: Past, present, and future perspectives

“…At a 24 ± 12‐month follow‐up, an 80% freedom from arrhythmias was achieved; a high long‐term complete LAA sealing (92%) was described, with all other patients experiencing a <5‐mm leakage. These results were then confirmed at a longer follow‐up and in a larger patient sample by a second study from the same group . Combined procedure feasibility, safety, and effectiveness regardless of the energy source for PVI (RF or Cryo) and device brand choice was demonstrated with this experience; no evidence of the superiority of an energy source on the other are available to date, leaving the option (and the burden) of the choice to the operator .…”

“…In 2016, cryo‐energy instead of RF as an energy source was introduced in the combined procedure by Fassini et al They reported the safety and feasibility of the technique using cryo‐energy delivered through first‐ and second‐generation cryoballoons in a high stroke risk population. In their pilot study, 35 patients were enrolled and underwent cryoballoon PVI alongside WATCHMAN or ACP LAAC; periprocedural reported adverse event rate and procedural time resulted comparable to previous RF CA combined procedure experiences.…”

Acute left atrial ridge lesion after cryoballoon ablation: How does this affect left atrial appendage closure combined procedure?

“…Moreover, Fassini et al 17 were the first to report comparable results of the combined procedure, utilizing only CB for ablation in 35 AF patients. Thenceforth, several studies have provided further evidence to support the feasibility of the CB ablation combined procedure, 7,12 showing comparable clinical outcomes with the RF combined procedure 4–6 . The CB ablation combined procedure forms a novel approach for AF management.…”

“…Since 2012, combining catheter ablation with left atrial appendage closure (LAAC) has been reported as a promising therapy for patients with AF 4 . Since then, several centers worldwide have reported considerable efficacy and safety of this combined procedure 5–7 . Notably, the presence of prominent acute LAR lesions after the combined procedure has been reported in some studies 8,9 .…”