Long-term results of efficacy and safety of pulmonary vein isolation with a catheter-tissue pressure sensor and a second-generation cryoballon in patients with persistent atrial fibrillation

Azizov S.N., Kozhenov A.T., Krivosheev YU.S., Nekrasova A.N.

Objective: to conduct a comparative assessment of the annual efficacy and safety of pulmonary vein (PVs) isolation with a catheter with a catheter-tissue pressure sensor and a second-generation cryoballon in patients with persistent atrial fibrillation (AF). To assess the dynamics of quality of life indicators for patients of both groups based on the AFEQT questionnaire

Materials and methods: a randomized prospective, single-center study was conducted. The study involved only 70 patients with a persistent form of AF who were randomized into two groups: group 1 (n = 35) — primary isolation of PVs by radiofrequency ablation using a catheter with a catheter-tissue pressure sensor. Group 2 (n = 35) — primary isolation of PVs with a second-generation cryoballon. The observation period was 12 months. A recurrence of atrial fibrillation was considered to be any paroxysm of atrial tachyarrhythmia, lasting more than 30 seconds, arising after the expiration of the “blind period” of the study. In both groups, the dynamics of indicators of the quality of life of patients was calculated based on the AFEQT questionnaire.

Results: acute isolation of PVs in the radiofrequency ablation group (RF) was achieved in 100% of PVs, in the cryoballon ablation group (CB) — 97.8% of PVs. The total duration of the procedure (125.3±6.8 versus 93.4±7.3 minutes, p = <0.001) was shorter for the CB group; fluoroscopy time (5.06±0.45 versus 13.57±0.87 minutes, p = <0.001) was significantly less in the RF group. There were no significant differences in the prevalence of intraoperative and postoperative complications between the groups: 1 episode of transient paresis of the phrenic nerve in the CB group was revealed. Complications such as hemopericardium, cerebrovascular accident, post-puncture hematoma were not registered in patients of any of the groups. At a 12-month follow-up, freedom from AF / atrial tachyarrhythmias without antiarrhythmic drugs was comparable in both groups: in the CB group it was 71.4%, in the RF group — 68.6%. A significant improvement was obtained in all indicators of the quality of life of patients with persistent AF at the AFEQT scale.

Conclusion: the long-term effectiveness and safety of PVs isolation of persistent AF with a catheter with a catheter-tissue pressure sensor and a second-generation cryoballon is comparable. RF ablation with a catheter with a catheter-tissue pressure sensor and CB ablation with a second-generation balloon significantly improve all quality of life indicators for patients with persistent AF based on AFEQT data.

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