Adding Non‐Occlusive Cryoballoon Ablation in Case of Ostial‐Level Pulmonary Vein Isolation or Carina Sparing Does Not Improve 1‐Year Outcome After Cryoballoon Ablation (the NOCA‐AF Study)
Year: 2025
Type: article
Study designs: Randomized Controlled Trial, Clinical Trial
Abstract: INTRODUCTION: Fixed-diameter cryoballoon ablation (CBA) can yield suboptimal ostial-level pulmonary vein isolation (PVI) and spare arrhythmogenic sites like the carina. The addition of non-occlusive cryoballoon ablation (NOCA) could overcome this limitation of CBA. We aimed to assess the need and effectiveness of NOCA and its impact on clinical outcomes. METHODS AND RESULTS: One hundred AF patients (66 ± 10 years, 40 females) were prospectively randomized to CBA (Control group, n = 50) or CBA + NOCA if needed (Study group, n = 50). Ostial-level PVI and carina sparing was assessed by electroanatomic left atrial (LA) voltage mapping after CBA. Endpoint was documented AF/AFL/AT ( > 30 s) at 12 months, with Holters at 6 and 12 months. After CBA, ostial PVI level was seen in 110 out of 392 veins (28%), with predominance of the left superior PV and carina sparing in 11 (11%) left PVs and 16 (16%) right PVs. Overall, voltage mapping displayed a potential NOCA need in 68 (68%) patients. Spatially, for both PV sides, preferential ostial-level PVI segments were situated at the posterior wall. NOCA was added in 38 (76%) study patients, confirmed effective in all by voltage remapping. At 1 year, AF/AFL/AT recurrence occurred in 12 (24%) Study and 6 (12%) control patients (p = 0.121). CONCLUSIONS: Ostial-level PVI and carina sparing occurs in a substantial amount of patients treated by CBA. Although NOCA proved effective in extending the lesion size to antral-level PVI or carina ablation, adding NOCA did not improve 1-year clinical outcome.
DOI: 10.1111/jce.70011
Language: English
Subfield: Cardiology and Cardiovascular Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: green
OpenAlex ID: W4412487267