Impact of comorbidity on the efficacy and safety of cryoballoon pulmonary vein Isolation in atrial fibrillation

M. Rothe (Wiesbaden)1, A. Böhmer (Wiesbaden)1, P. Spork (Wiesbaden)1, K. Schneider (Wiesbaden)1, L. Wiedenmann (Wiesbaden)1, S. E. Nußbaum (Wiesbaden)1, C. Keim (Wiesbaden)1, P. Weiß (Wiesbaden)1, B.-C. Dobre (Wiesbaden)1, B. Kaess (Wiesbaden)1, J. Ehrlich (Wiesbaden)1
1St. Josefs Hospital Medizinische Klinik I Wiesbaden, Deutschland

Background
Cardiovascular diseases and advanced age are recognized risk factors for atrial fibrillation (AF). Recent evidence supports a prognostic benefit from rhythm control strategies, primarily achieved through catheter ablation. However, a high comorbidity burden may influence efficacy and the incidence of cardiovascular events following pulmonary vein isolation (PVI).

Methods
This prospective study included consecutive AF patients who underwent first-time PVI with cryoballoon (cryoPVI) between 2018 and 2024. Patients were grouped based on comorbidity burden (CHA2DS2-VA score <4 or ≥4). CryoPVI was conducted using a standardized protocol, with follow-up assessments at 3, 6, and 12 months. The primary efficacy endpoint was symptomatic atrial arrhythmia relapse, while the secondary endpoint included a composite of cardiovascular death, stroke or transient ischemic attack, and hospitalization for heart failure or acute coronary syndrome, consistent with the EAST-AFNET4 trial criteria. Periprocedural parameters were also evaluated.

 

Results
A total of 1402 patients were included, of whom 281 (20%) had a CHA2DS2-VA score ≥4. Mean follow-up duration was 11±3 months. Patients with CHA2DS2-VA ≥4 were older (77 vs. 67 years; P<0.0001) and had a higher prevalence of 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 prior stroke (26% vs. 2%; P<0.0001). At 12 months, atrial arrhythmia relapse was significantly higher in patients with a high comorbidity burden (29% vs. 22%, hazard ratio 1.44; 95% confidence interval 1.1–1.9; log-rank P<0.01). No significant difference was observed for the secondary endpoint (2.7% vs. 1.7%, hazard ratio 1.9; 95% confidence interval 0.65–5.23; log-rank P=0.17). 
Procedural parameters did not differ between groups.

Summary & Conclusion 

CryoPVI proves to be less effective in patients with high comorbidity burden, however it does not increase the likelihood of adverse cardiovascular events.