著者
Roland Richard Tilz Roza Meyer-Saraei Charlotte Eitel Thomas Fink Vanessa Sciacca Lisbeth Delgado Lopez Bettina Kirstein Michael Schlüter Julia Vogler Karl-Heinz Kuck Christian-H. Heeger
出版者
The Japanese Circulation Society
雑誌
Circulation Journal (ISSN:13469843)
巻号頁・発行日
pp.CJ-21-0094, (Released:2021-04-13)
参考文献数
18
被引用文献数
28

Background:The arctic front cryoballoon (AF-CB) provides effective and durable pulmonary vein isolation (PVI) associated with encouraging clinical outcome. The POLARx cryoballoon incorporates unique features and design changes that may translate into improved efficacy, safety and further simplified balloon-based procedures. Efficacy and safety of the novel POLARx cryoballoon was compared to the fourth generation AF-CB (AF-CB4).Methods and Results:Twenty-five consecutive patients with paroxysmal or persistent atrial fibrillation were prospectively enrolled, underwent POLARx-based PVI (POLARx group) and were compared to 25 consecutive patients treated with the AF-CB4 (AF-CB4 group). All PVs were successfully isolated utilizing the POLARx and AF-CB4. A significant difference regarding the mean minimal cryoballoon temperatures reached using the AF-CB4 and POLARx (−50±6℃ vs. −57±7℃, P=0.004) was observed. Real-time PVI was visualized in 81% of POLARx patients and 42% of AF-CB4 patients (P<0.001). Utilizing the POLARx, a trend towards shorter median procedure time (POLARx: 45 [39, 53] min vs. AF-CB4: 55 [50, 60] min; P=0.062) was found. No differences were observed between AF-CB4 and POLARx concerning catheter maneuverability, catheter stability and periprocedural complications.Conclusions:The novel POLARx showed similar safety and efficacy compared to the AF-CB4. A higher rate of real-time PV recordings and significantly lower minimal balloon temperatures were observed using the POLARx.
著者
Christian-H. Heeger Huong-Lan Phan Roza Meyer-Saraei Thomas Fink Vanessa Sciacca Spyridon Liosis Ben Brüggemann Niels Große Bezhad Fahimi Makoto Sano Karl-Heinz Kuck Feifan Ouyang Julia Vogler Charlotte Eitel Roland Richard Tilz
出版者
The Japanese Circulation Society
雑誌
Circulation Journal (ISSN:13469843)
巻号頁・発行日
pp.CJ-19-0766, (Released:2019-11-09)
参考文献数
29
被引用文献数
22

Background:Radiofrequency (RF)-based pulmonary vein isolation (PVI) results in a favorable clinical outcome, although its complexity demands a long learning curve. Balloon-based systems have been developed to possibly solve these limitations. The 2nd-generation laser balloon (LB2) offers optimized features for improved tissue contact and visibility. We determined the safety, efficacy and learning curve of the LB2 for PVI.Methods and Results:A total of 45 consecutive patients (89% persistent AF) were prospectively enrolled and divided into 3 groups (T1, T2, T3) of n=15 patients per group. All patients underwent PVI by 2 operators using the LB2. The operators were experienced in RF and cryothermal procedures, but not in laser ablations. A total of 174/177 PVs (98%) were successfully isolated. The median procedure time significantly declined from 132 (114, 158) to 119 (102, 127) and 91 (86, 105) min in T1–3, respectively (P=0.0009). Similarly, the median fluoroscopy time significantly decreased from T1 to T3 (22 (17, 27) vs. 21 (16, 24) vs. 13 (10, 17) min, respectively, P=0.045). Adverse events occurred in 6.7%, with a trend towards a lower complication rate with increasing experience.Conclusions:The LB2 was safe and effective for PVI, even for operators without any previous experience in laser balloon-based PVI. Procedure time, left atrial dwelling time and fluoroscopy time decreased after a learning curve of 15 cases.
著者
Christian-Hendrik Heeger Enida Rexha Sabrina Maack Laura Rottner Thomas Fink Shibu Mathew Tilman Maurer Christine Lemeš Andreas Rillig Peter Wohlmuth Bruno Reissmann Roland Richard Tilz Feifan Ouyang Karl-Heinz Kuck Andreas Metzner
出版者
The Japanese Circulation Society
雑誌
Circulation Journal (ISSN:13469843)
巻号頁・発行日
pp.CJ-19-1144, (Released:2020-04-18)
参考文献数
20
被引用文献数
17

Background:The second-generation cryoballoon (CB2) has demonstrated high procedural efficacy and convincing clinical success rates for pulmonary vein isolation (PVI). Nevertheless, data on the impact of different ablations protocols on durability are limited. The aim was to comparing the durability of PVI following 3 different ablation strategies in patients with recurrence of atrial fibrillation or atrial tachycardia undergoing repeat procedures.Methods and Results:In 192 patients, a total of 751 PVs were identified. All PVs were successfully isolated during index PVI. Thirty-one out of 192 (16%) patients were treated with a bonus-freeze protocol (group 1), 67/192 (35%) patients with a no bonus-freeze protocol (group 2), and 94/192 (49%) patients with a time-to-effect-guided protocol (group 3). Persistent PVI was documented in 419/751 (55.8%) PVs, and in 41/192 (21%) patients, all PVs were persistently isolated. The total rate of PV reconnection was not significantly different between the groups (P=0.134) and the comparison of individual PVs revealed no differences (P-values for RSPV: 0.424, RIPV: 0.541, LSPV: 0.788, LIPV: 0.346, LCPV: 0.865). The procedure times were significantly reduced by omitting the bonus-freeze and applying individualized application times (group 1: 123.4±31.5 min, group 2: 112.9±39.8 min, group 3: 86.67±28.4 min, P<0.001).Conclusions:Comparing 3 common ablation protocols, no differences for durable PVI were detected. Procedure times were significantly reduced by omitting the bonus-freeze cycle and by applying individualized application times.
著者
Christian-Hendrik Heeger Amr Abdin Shibu Mathew Bruno Reissmann Kivanc Yalin Spyridon Liosis Thomas Fink Riccardo Proietti Charlotte Eitel Julia Vogler Christine Lemeš Tilman Maurer Andreas Rillig Roza Meyer-Saraei Tobias Graf Peter Wohlmuth Britta Goldmann Feifan Ouyang Karl-Heinz Kuck Andreas Metzner Roland Richard Tilz
出版者
The Japanese Circulation Society
雑誌
Circulation Journal (ISSN:13469843)
巻号頁・発行日
pp.CJ-19-0151, (Released:2019-06-28)
参考文献数
22
被引用文献数
20

Background:Second-generation cryoballoon (CB2)-based pulmonary vein isolation (PVI) has demonstrated encouraging results in the treatment of atrial fibrillation (AF). This study sought to assess data on the safety, efficacy and clinical success of CB2-based PVI in patients with heart failure (HF) and reduced ejection fraction (HFrEF).Methods and Results:CB2-based PVI was performed in 551 consecutive patients in 3 highly experienced EP centers. Patients with HF and LVEF ≤40% were included (HFrEF group, n=50/551, 9.1%). Data were compared with propensity score-matched patients without HF and preserved left ventricular EF (LVEF) (n=50, control group). The median LVEF was HFrEF: 37% (35, 40) and control: 55% (55, 55), P<0.0001. Major periprocedural complications were registered in 4/50 (8%, HFrEF group) and 3/50 (6%, control group), P=0.695. The 12-month freedom from AF recurrence was 73.1% (95% confidence interval (CI): 61–88, HFrEF group) and 72.6% (95% CI: 61–87, control group), P=0.25. NYHA class decreased from 2.4±0.8 (baseline) to 1.7±0.8 at 12-month follow-up (P<0.0001). LVEF improved from a median of 37% (35, 40) prior to ablation to a median of 55% (40, 55), P<0.0001.Conclusions:CB2-based PVI in patients with HFrEF appeared to be safe, was associated with comparable periprocedural complications and showed promising clinical success rates equal to those for patients with preserved LVEF. NYHA class and LVEF significantly improved at 12-month follow-up.
著者
Christian-H. Heeger Erik Wissner Milena Knöll Benedikt Knoop Bruno Reissmann Shibu Mathew Christian Sohns Christine Lemes Tilman Maurer Francesco Santoro Johannes Riedl Osamu Inaba Thomas Fink Laura Rottner Peter Wohlmuth Britta Goldmann Feifan Ouyang Karl-Heinz Kuck Andreas Metzner
出版者
日本循環器学会
雑誌
Circulation Journal (ISSN:13469843)
巻号頁・発行日
pp.CJ-16-1334, (Released:2017-03-24)
参考文献数
28
被引用文献数
52

Background:Pulmonary vein isolation (PVI) using the 2nd-generation cryoballoon (CB2) for the treatment of atrial fibrillation (AF) has demonstrated encouraging acute and mid-term results. However, follow-up data on outcomes beyond 1 year are sparse. We investigated the 3-year outcome after PVI using the CB2.Methods and Results:100 patients with paroxysmal (PAF, 70/100 [70%] patients) or persistent AF (pAF, 30/100 [30%] patients) underwent CB2-based PVI in 2 experienced centers in Germany. Freeze-cycle duration was 240 s. After successful PVI a bonus freeze-cycle of the same duration was applied in the first 71 patients but was omitted in the following 29 patients. Phrenic nerve palsy occurred in 3 patients (3%); 2 patients were lost to follow-up. After a median follow-up of 38 (29–50) months, 59/98 (60.2%) patients remained in stable sinus rhythm (PAF: 48/70 (69%), pAF: 11/28 (39%) P=0.0084). In 32/39 (77%) patients with arrhythmia recurrence, a second ablation procedure using radiofrequency energy was conducted. Persistent PVI was noted in 76/125 (61%) PVs. After a mean of 1.37±0.6 procedures and a median follow-up of 35 (25–39) months, 77/98 (78.6%) patients remained in stable sinus rhythm (PAF: 56/70 (80%), pAF: 20/28 (71%), P=0.0276).Conclusions:CB2-based PVI resulted in a 60.2% single-procedure and a 78.6% multiple-procedure success rate after 3 years. Repeat procedures demonstrated a high rate of durable PVI.
著者
Christian-Hendrik Heeger Enida Rexha Sabrina Maack Laura Rottner Thomas Fink Shibu Mathew Tilman Maurer Christine Lemeš Andreas Rillig Peter Wohlmuth Bruno Reissmann Roland Richard Tilz Feifan Ouyang Karl-Heinz Kuck Andreas Metzner
出版者
The Japanese Circulation Society
雑誌
Circulation Journal (ISSN:13469843)
巻号頁・発行日
vol.84, no.6, pp.902-910, 2020-05-25 (Released:2020-05-25)
参考文献数
20
被引用文献数
8 17

Background:The second-generation cryoballoon (CB2) has demonstrated high procedural efficacy and convincing clinical success rates for pulmonary vein isolation (PVI). Nevertheless, data on the impact of different ablations protocols on durability are limited. The aim was to comparing the durability of PVI following 3 different ablation strategies in patients with recurrence of atrial fibrillation or atrial tachycardia undergoing repeat procedures.Methods and Results:In 192 patients, a total of 751 PVs were identified. All PVs were successfully isolated during index PVI. Thirty-one out of 192 (16%) patients were treated with a bonus-freeze protocol (group 1), 67/192 (35%) patients with a no bonus-freeze protocol (group 2), and 94/192 (49%) patients with a time-to-effect-guided protocol (group 3). Persistent PVI was documented in 419/751 (55.8%) PVs, and in 41/192 (21%) patients, all PVs were persistently isolated. The total rate of PV reconnection was not significantly different between the groups (P=0.134) and the comparison of individual PVs revealed no differences (P-values for RSPV: 0.424, RIPV: 0.541, LSPV: 0.788, LIPV: 0.346, LCPV: 0.865). The procedure times were significantly reduced by omitting the bonus-freeze and applying individualized application times (group 1: 123.4±31.5 min, group 2: 112.9±39.8 min, group 3: 86.67±28.4 min, P<0.001).Conclusions:Comparing 3 common ablation protocols, no differences for durable PVI were detected. Procedure times were significantly reduced by omitting the bonus-freeze cycle and by applying individualized application times.