Comparison of pulsed field ablation and cryoballoon ablation for pulmonary vein isolation

Abstract

IntroductionPulmonary vein isolation (PVI) remains the cornerstone in the treatment of atrial fibrillation (AF). PVI using cryoballoon (CB) technology has emerged as a standard procedure in many centers. Recently, pulsed field ablation (PFA) has been introduced and used to achieve PVI. First data show high acute and favorable long‐term outcomes. So far, data comparing these new “single shot” devices are sparse. We sought to compare procedural and outcome data for first time PFA users versus CB in patients undergoing de novo PVI. Furthermore, potentially postprocedural discomfort and affection of autonomic ganglia were assessed.Methods and ResultsA retrospective analysis and comparison of all de novo PVIs with PFA and CB was performed. Furthermore, PFA PVI learning curve was evaluated. During follow‐up, repeat outpatient visits and Holter electrocardiogram were performed to analyze arrhythmia‐free survival. Discomfort analysis was obtained by prescribed analgesic medication within first 48 h after PVI. Potential changes in heart rate (HR) between baseline and at 3‐month follow‐up were evaluated. A total of 108 patients (54 PFA and 54 CB; PFA; 33 (30%) female) with paroxysmal and persistent AF were analyzed. Type of AF was comparable (Patients suffering from PAF: PFA: 16 (30%), CB: 17 (31%), p = 1.0). In 107 (99%) patients, successful PVI was achieved. Transient phrenic palsy omitted complete PVI in one CB patient. A trend for a shorter overall procedure duration was observed in the PFA group (PFA: 64.5 ± 17.5 min; CB: 73.0 ± 24.8 min; p = 0.07). Excluding LA mapping time (first 14 cases), procedure time was significantly shorter using PFA (PFA: 58.0 ± 12.5 min, CB: 73.0 ± 24.8 min, p = 0.0001). Fluoroscopy time was significantly longer for PFA (PFA: 15.3 ± 4.7 min, CB: 12.3 ± 5.3 min; p = 0.001), but significantly less contrast medium was used (PFA: 12 ± 6 mL; CB: 51 ± 29 mL, p < 0.0001). Subgroup analysis of the PFA group revealed a significant shortening of procedure duration over time (first tertile: 72.7 ± 13.5 min, second tertile: 67.3 ± 21.7 min, third tertile: 53.4 ± 9.8 min, first vs. third tertile p < 0.0001). Two cardiac tamponades occurred in the PFA group (p = 0.495), of which one was most likely related to complex transseptal puncture. In the first 48 h after PVI, the number of prescribed analgesics due to postprocedural pain was equal between both groups (PFA: 7 (13%) patients, CB: 10 (19%) patients, p = 0.598). After a FU of 273 ± 129 days, 35 of 47 patients (74%) after PFA and 36 of 50 patients (72%) after CB PVI were free of any atrial arrhythmia (HR: 0.98, p = 0.88). Only in the PFA group, a significant increase in HR 3 months after PVI was observed (pre‐PVI: 61 ± 8 beats/min, post‐PVI: 65 ± 9 beats/min, p = 0.008).ConclusionThe new PFA technology is equally effective and safe as compared to CB for complete PVI with potentially shorter procedure time and significantly less contrast medium. However, AF recurrence rates after PFA PVI seem to be comparable to CB PVI.

Pulsed field ablation for atrial fibrillation: Moving the field forward?

“…So, what is the current state of play on the field of AF ablation? The data from Schippner et al 2 provide support for the role of PFA as a faster, and potentially safer, approach to AF ablation, especially once operators overcome the initial learning curve. However, the extent to which PFA will move the field forward in terms of efficacy remains unclear.…”

“…However, PFA is not without complications. Schipper et al 2 report two cases of cardiac tamponade in the PFA group and in the ADVENT trial, there were also two cases of tamponade…”

“…Part of the reduction in procedure time may have been related to the use of electroanatomic mapping during the initial PFA cases, a step which was eliminated with later cases. But even accounting for this change, 2 the data from Schipper and colleagues clearly show evidence of a learning curve with PFA. These results are consistent with prior studies demonstrating a learning curve with PFA, even among highly experienced AF ablation operators 3 .…”

“…However, PFA is not without complications. Schipper et al 2 report two cases of cardiac tamponade in the PFA group and in the ADVENT trial, there were also two cases of tamponade in the PFA arm and the overall rate of major complications was similar between PFA and thermal ablation 5 . It is conceivable that complications such as tamponade associated with PFA will improve with increased operator experience, although only time will tell.…”

“…Finally, and perhaps most importantly, the results from Schipper et al 2 provide a sobering assessment of efficacy outcomes associated with PFA. AF‐free survival was no different between PFA and CB, a finding consistent with other head‐to‐head studies of PFA versus thermal ablation 5,7 .…”