Two Versus One Repeat Freeze–Thaw Cycle(s) After Cryoballoon Pulmonary Vein Isolation: The ALSTER EXTRA Pilot Study

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Abstract
Two versus One Repeat Freeze–Thaw Cycle(s). Background: Repeated freezing (bonus applications) during cryoballoon pulmonary vein isolation (PVI) has been suggested to improve lesion durability. However, the long‐term clinical effects of repeated freezing have not been investigated. Methods and Results: A total of 51 patients (pts) with paroxysmal atrial fibrillation (AF) underwent PVI using the single big (28 mm) cryoballoon technique. One (27 pts, group I) or 2 bonus applications (24 pts, group II) were performed at all PVs subsequent to PVI. Clinical follow‐up consisted of continuous rhythm monitoring by an implantable cardiac monitor (ICM, 24 pts) and serial 7‐day Holter‐ECG recording (7DH, 27 pts). The primary endpoint was defined as recurrent AF or atrial tachycardia. Acute PVI of all PVs was obtained in 50/51 pts (98%). The median (Q1;Q3) follow‐up duration in this study was 384 (213;638) days. The primary endpoint occurred in 48% (group I, 15 pts ICM, 12 pts 7DH) and 46% (group II, 9 pts ICM, 15 pts 7DH), P = 0.84. Procedure‐ and fluoroscopy‐time for group I versus group II was 193 ± 56 minutes versus 207 ± 27 and 33 ± 13 minutes versus 34 ± 11 minutes, respectively. Right phrenic nerve palsy (PNP) occurred in 3 pts (all group II, time to resolution: 128 ± 112 days). In 2 of these pts, PNP occurred during the second bonus application. Conclusion: Application of 2 when compared to 1 freeze–thaw cycle(s) following cryoballoon PVI did not result in improved clinical success but was associated with a higher complication rate. (J Cardiovasc Electrophysiol, Vol. 23, pp. 814‐819, August 2012)

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