Standalone transcatheter left atrial appendage closure or combined with cryoballoon pulmonary vein isolation

Abstract

Abstract Background Head-to-head comparisons between stand-alone left atrial appendage closure (LAAC) and a same-procedure LACC + cryoballoon (CB) pulmonary vein isolation (PVI) (combined procedure) are currently lacking. Purpose To compare acute and long-term outcomes between stand-alone LAAC vs a LAAC+CB-PVI combined procedure. Methods All patients undergoing LAAC at our institution, having at least 2 years follow-up, were analyzed to assess the impact of additional CB-PVI. The primary efficacy and safety endpoints of our study were the acute procedural success rate and the peri-procedural complications rate. As secondary endpoints, major bleeding, and ischemic events, as well as sinus rhythm rate at 2 years follow-up were assessed. Results Among 126 LAAC patients meeting inclusion criteria (males=64.2%), n=55 (43.7%) underwent a combined procedure. LAAC-only patients were older (72.5±7.2 vs 68.9±8.6, p<0.05) and less frequently having paroxysmal AF (23.9% vs 47.3%, p<0.05). Baseline CHA2DS2-VASc was similar among groups (3.3±1.3 vs 2.9±1.1, p=0.07) while LAAC-only patients had higher HAS-BLED at enrollment (3.4±1.1 vs 3.0±1.0, p=0.04). Additional CB-PVI was not a risk factor for incomplete LAA occlusion (OR 0.24–3.78, p=0.96), presence of residual lateral flow (OR 0.26–4.05; p=0.96), intraprocedural need for occluder device resizing compared to pre-procedural assessment (OR 0.27–3.05; p=0.884), and peri-procedural complications (OR 0.25–6.74, p=0.749). At 3-month post-procedural trans-esophageal echocardiography, a combined procedure was not associated with higher risk of incomplete occlusion (OR 0.33–1.59, p = 0.432), nor larger peri-device leakages (coefficient k: -0.65–+0.20, p=0.291). Overall and by-group ischemic (red) and bleeding (blue) relative risk reduction from CHA2DS2-VASc and HAS-BLED predicted yearly rates during follow-up was reported in Figure1. Over a median follow-up of 40 [26–56] months, a combined procedure was not a risk factor for major bleeding (OR 0.31–5.48, p=0.715) or ischemic (OR 0.11–3.56, p=0.599) events. As expected, additional CB-PVI was strongly associated with a reduction of AF recurrences (OR 0.16–0.86, p<0.05), after excluding permanent AF patients from the analysis. Conclusion Combined LAAC + CB-PVI procedure does not appear to be a risk factor for worse LAAC-related outcomes, while reducing AF recurrences in non-permanent AF patients.Figure 1