Cryoballoon pulmonary vein isolation in patients with high comorbidity burden

Abstract Background Cardiovascular diseases and increasing age are risk factors for the occurrence of atrial fibrillation (AF). Current data provide evidence for a prognostic benefit from rhythm control strategy, which is most effectively achieved by catheter ablation. High comorbidity burden may impact on procedural efficacy and incidence of cardiovascular events following pulmonary vein isolation (PVI). Methods Consecutive AF patients who underwent first-time PVI with cryoballoon (cryoPVI) were prospectively included in this study between 2018 and 2024. Patients were dichotomized into groups depending on comorbidity burden (CHA2DS2-VA<4 or ≥4). CryoPVI was performed in a standardized fashion and follow-up was at 3, 6, 12, 18, 24, and 36 months. The primary efficacy endpoint was symptomatic atrial arrhythmia recurrence. The secondary endpoint was a composite of cardiovascular death, stroke or transient ischemic attack and hospitalization for heart failure or acute coronary syndrome in analogy to the EAST-AFNET4 trial. Periprocedural parameters were observed. Results Overall, 1402 patients were included of which 1121 (69%) had CHA2DS2-VA<4. Mean follow-up was 21±12 months. Patients with CHA2DS2-VA≥4 were older (77 vs. 67 years; P<0.0001) and more likely to have persistent AF (48% vs 37%, P=0.0008), hypertension (89% vs 61%; P<0.0001), diabetes (33% vs. 7%; P<0.0001), coronary artery disease (48% vs. 12%; P<0.0001) and previous stroke (26% vs. 2%; P<0.0001). At 36 months, atrial arrhythmia recurrence (50% vs. 43%, hazard ratio 1.33; 95% confidence interval, 1.06 to 1.66; log-rank P<0.0001) occurred significantly more frequent in patients with high comorbidity burden, while no difference was observed for the occurrence of the secondary endpoint (4.6% vs. 3.6%, hazard ratio 1.59; 95% confidence interval, 0.64 to 3.53; log-rank P=0.29). There was no difference in procedural parameters. Summary & Conclusion CryoPVI is less effective in patients with a high comorbidity burden, however, it does not appear to increase the risk of cardiovascular death, stroke or transient ischemic attack and hospitalization for heart failure or acute coronary syndrome.