Shorter RSPV cryoapplications result in less phrenic nerve injury and similar 1-year freedom from atrial fibrillation.

BACKGROUND: In the 123-study, we prospectively assessed, in a randomized fashion, the minimal cryoballoon application time necessary to achieve pulmonary vein (PV) isolation (PVI) in patients with paroxysmal atrial fibrillation (AF) with the aim to reduce complications by shortening the application duration. The first results of this study demonstrated that shortened cryoballoon applications (<2 minutes) resulted in less phrenic nerve injury (PNI) without compromising acute isolation efficacy for the right PVs. We now report the 1-year follow-up results regarding safety and efficacy of shorter cryoballoon applications. METHODS: A total of 222 patients with AF were randomized to two applications of 1 min "short," 2 min "medium," or 3 min "long" duration, 74 per group. Recurrence of AF and PV reconduction at 1-year follow-up were assessed. RESULTS: The overall 1-year freedom from AF was 79% and did not differ significantly between the short, medium, and long application groups (77%, 74%, and 85% for short, medium, and long application groups, respectively; P = 0.07). In 30 patients, a redo PVI procedure was performed. For all four PVs, there was no significant difference in reconduction between the three groups. Reconduction was most common in the left superior PV (57%). The right superior PV (RSPV) showed significantly less reconduction (17%) compared to the other PVs. CONCLUSIONS: Shortening cryoballoon applications of the RSPV to <2 minutes results in less PNI, while acute success and 1-year freedom from AF are not compromised. Therefore, shorter cryoballoon applications (especially) in the RSPV could be used to reduce PNI.

Shorter cryoballoon applications times do effect efficacy but result in less phrenic nerve injury: Results of the randomized 123 study.

BACKGROUND: The second-generation cryoballoon significantly improves outcome of pulmonary vein isolation (PVI) but may cause more complications than the first generation. Currently, no consensus regarding optimal cryoballoon application time exists. The 123-study aimed to assess the minimal cryoballoon application duration necessary to achieve PVI (primary endpoint) and the effect of application duration on prevention of phrenic nerve injury (PNI). METHODS: Patients <75 years of age with paroxysmal atrial fibrillation, normal PV anatomy, and left atrial size <40 cc/m² or <50 mm were randomized to two applications of different duration: "short," "medium," or "long." A total of 222 patients were enrolled, 74 per group. RESULTS: Duration per application was 105 (101-108), 164 (160-168), and 224 (219-226) s and isolation was achieved in 79, 89, and 90% (P < 0.001) of the PVs after two applications in groups short, medium, and long, respectively. Only for the left PVs, the success rate of the short group was significantly less compared to the medium- and long-duration groups (P < 0.001). PNI during the procedure occurred in 19 PVs (6.5%) in the medium and in 20 PVs (6.8%) in the long duration groups compared to only five PVs (1.7%) in the short duration group (P < 0.001). CONCLUSIONS: Short cryoballoon ablation application times, less than 2 min, did affect the success for the left PVs but not for the right PVs and resulted in less PNI. A PV tailored approach with shorter application times for the right PVs might be advocated.