One-year clinical success of a 'no-bonus' freeze protocol using the second-generation 28 mm cryoballoon for pulmonary vein isolation
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One-year clinical success of a 'no-bonus' freeze protocol using the second-generation 28 mm cryoballoon for pulmonary vein isolation. / Wissner, Erik; Heeger, Christian-Hendrik; Grahn, Hanno; Reissmann, Bruno; Wohlmuth, Peter; Lemes, Christine; Rausch, Peter; Mathew, Shibu; Rillig, Andreas; Deiss, Sebastian; Maurer, Tillman; Lin, Tina; Tilz, Roland Richard; Ouyang, Feifan; Kuck, Karl-Heinz; Metzner, Andreas.
In: EUROPACE, Vol. 17, No. 8, 08.2015, p. 1236-40.Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review
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TY - JOUR
T1 - One-year clinical success of a 'no-bonus' freeze protocol using the second-generation 28 mm cryoballoon for pulmonary vein isolation
AU - Wissner, Erik
AU - Heeger, Christian-Hendrik
AU - Grahn, Hanno
AU - Reissmann, Bruno
AU - Wohlmuth, Peter
AU - Lemes, Christine
AU - Rausch, Peter
AU - Mathew, Shibu
AU - Rillig, Andreas
AU - Deiss, Sebastian
AU - Maurer, Tillman
AU - Lin, Tina
AU - Tilz, Roland Richard
AU - Ouyang, Feifan
AU - Kuck, Karl-Heinz
AU - Metzner, Andreas
N1 - Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2015. For permissions please email: journals.permissions@oup.com.
PY - 2015/8
Y1 - 2015/8
N2 - AIMS: Studies on the use of the second-generation 28 mm cryoballoon (CB) for the treatment of atrial fibrillation (AF) have reported superior 1-year clinical outcome. Customarily, a bonus freeze cycle is applied after pulmonary vein isolation (PVI). The purpose of the present study was to assess the 1-year clinical outcome following PVI foregoing a bonus freeze cycle.METHODS AND RESULTS: Patients with drug-refractory paroxysmal AF (PAF) or persistent AF underwent PVI using the second-generation 28 mm CB. The freeze cycle duration was set at 240 s. No bonus freeze cycle was applied. Clinical follow-up (FU) included 12-lead ECGs and 24h-Holter ECGs at 3, 6, and 12 months. A total of 45 patients (age 60 ± 11 years, mean LA diameter 42.1 ± 8.6 mm, n = 38 [84%] PAF) underwent CB-based PVI. Of 177 pulmonary veins (PVs) identified, 176/177 (99%) PVs were successfully isolated. The mean number of CB applications was 1.2 ± 0.4, 1.5 ± 0.8, 1.4 ± 0.7, 1.1 ± 0.3 and 1.7 ± 1.2 for the right superior PVs, right inferior PVs, left superior PVs, left inferior PVs, and left common PVs, respectively. Mean procedure and fluoroscopy times were 113 ± 32 and 19 ± 7 min, respectively. Phrenic nerve palsy occurred in 1/45 (2%) patients. One of 45 (2%) patients was lost to FU. After a mean FU period of 392 ± 58 (267-522) days including a 3-month blanking period, 36 of 44 (82%) patients remained in stable sinus rhythm. Five out of eight patients with arrhythmia recurrence underwent a second procedure. Only those PVs isolated with a single freeze cycle (5/11 PVs, 45%) demonstrated PV reconduction. In contrast, no PV reconnection was found in PVs initially treated with multiple freeze cycles.CONCLUSIONS: A 'no-bonus'-freeze protocol for PVI using the second-generation 28 mm CB resulted in an 82% 1-year clinical success rate. A bonus freeze cycle following successful PVI may not be essential to superior clinical outcome.
AB - AIMS: Studies on the use of the second-generation 28 mm cryoballoon (CB) for the treatment of atrial fibrillation (AF) have reported superior 1-year clinical outcome. Customarily, a bonus freeze cycle is applied after pulmonary vein isolation (PVI). The purpose of the present study was to assess the 1-year clinical outcome following PVI foregoing a bonus freeze cycle.METHODS AND RESULTS: Patients with drug-refractory paroxysmal AF (PAF) or persistent AF underwent PVI using the second-generation 28 mm CB. The freeze cycle duration was set at 240 s. No bonus freeze cycle was applied. Clinical follow-up (FU) included 12-lead ECGs and 24h-Holter ECGs at 3, 6, and 12 months. A total of 45 patients (age 60 ± 11 years, mean LA diameter 42.1 ± 8.6 mm, n = 38 [84%] PAF) underwent CB-based PVI. Of 177 pulmonary veins (PVs) identified, 176/177 (99%) PVs were successfully isolated. The mean number of CB applications was 1.2 ± 0.4, 1.5 ± 0.8, 1.4 ± 0.7, 1.1 ± 0.3 and 1.7 ± 1.2 for the right superior PVs, right inferior PVs, left superior PVs, left inferior PVs, and left common PVs, respectively. Mean procedure and fluoroscopy times were 113 ± 32 and 19 ± 7 min, respectively. Phrenic nerve palsy occurred in 1/45 (2%) patients. One of 45 (2%) patients was lost to FU. After a mean FU period of 392 ± 58 (267-522) days including a 3-month blanking period, 36 of 44 (82%) patients remained in stable sinus rhythm. Five out of eight patients with arrhythmia recurrence underwent a second procedure. Only those PVs isolated with a single freeze cycle (5/11 PVs, 45%) demonstrated PV reconduction. In contrast, no PV reconnection was found in PVs initially treated with multiple freeze cycles.CONCLUSIONS: A 'no-bonus'-freeze protocol for PVI using the second-generation 28 mm CB resulted in an 82% 1-year clinical success rate. A bonus freeze cycle following successful PVI may not be essential to superior clinical outcome.
KW - Atrial Fibrillation/diagnosis
KW - Catheter Ablation/instrumentation
KW - Cryosurgery/instrumentation
KW - Equipment Design
KW - Equipment Failure Analysis
KW - Female
KW - Heart Conduction System/surgery
KW - Humans
KW - Longitudinal Studies
KW - Male
KW - Middle Aged
KW - Pulmonary Veins/surgery
KW - Treatment Outcome
U2 - 10.1093/europace/euv024
DO - 10.1093/europace/euv024
M3 - SCORING: Journal article
C2 - 25868468
VL - 17
SP - 1236
EP - 1240
JO - EUROPACE
JF - EUROPACE
SN - 1099-5129
IS - 8
ER -
