Validation of the Castle HTx data in a real world scenario

Abstract

Abstract Background Pulmonary vein isolation (PVI) is recommended in patients with symptomatic atrial fibrillation (AF) and reduced left ventricular ejection fraction (LVEF). Recently the Castle HTx (CHTx) trial showed a significant mortality reduction in end stage heart failure patients undergoing PVI in addition to optimized medical therapy (OMT) compared to OMT only. Aim Objective of this analysis is to validate results of Castle HTx study in a real world scenario. Methods All patients between September 2021 und September 2023 referred for PVI at our center with symptomatic AF und LVEF ≤35% were included in this retrospective analysis at the University Hospital Cologne. Results A total of 119 PVI in patients with LVEF≤35% were successfully performed (mean age 63.3±10.1 years, 96 patients (81%) male, 43 (36%) paroxysmal AF, 76 (64%) persistent AF) matching inclusion criteria used in CHTx. Cryo-PVI was used in 50 (42%), RF-PVI in 60 (50%) and PFA in 9 (8%) patients. Complete follow-up (FU) with a mean of 549.6±430.2 days was obtained in 108 patients, comparable to CHtx (540 days). During FU 11 patients (10%) died from any cause (CHTx 8 patients (8%)), 2 patients (2%) received a left ventricular assist device (CHTx 1 patient (1%)) and no patient had urgent heart transplantation (CHTx 1 patient (1%)). For 30 patients (28%) recurrence of AF was detected and 72% remained in sinus rhythm. In 6 patients (5%) post-procedural complications occurred: 5 inguinal hematoma, 1 decompensation. During FU LVEF was statistically significantly improved (EF initial 26.9±6.5%, EF FU (n=80) 37.1±12.8%, p<0.001) (CHTx EF initial 29.0±6.4%, EF FU (n=92) 37.2±9.1%). Conclusion The findings of the Castle HTx patients have been validated in a real-world setting. PVI for rhythm control in end stage heart failure patients is safe and highly effective. Our patient cohort, matched to the Castle HTx ablation group, showed freedom from AF rate of 72% after mean FU time of 550 days. Furthermore, LVEF was improved significantly in our cohort echoing the results from CHTx.