Department of Cardiac, Thoracic and Thoracic Vascular Surgery, Klinikum der Johann Wolfgang Goethe, Universitat Frankfurt Zentrum de Chirurgie, Frankfurt, Germany.
Regional Cardiology Department, Royal Victoria Hospital, Belfast, UK.
Eur J Cardiothorac Surg. 2018 Sep 1;54(3):467-474. doi: 10.1093/ejcts/ezy078.
To examine the incidence and timing of new-onset left bundle branch block (LBBB) and new permanent pacemaker implantation (PPI) in patients undergoing transcatheter aortic valve implantation (TAVI) using the repositionable, self-expanding Portico™ TAVI system (St. Jude Medical, St Paul, MN, USA). Clinical impact and periprocedural factors associated with new PPI were also assessed.
A total of 198 high-risk patients without pre-existing pacemaker [83.1 ± 4.7 years, 77.3% women, mean Society of Thoracic Surgeons (STS) 5.8%] from the Pre-CE Mark Portico TAVI system study were prospectively analysed. Twelve-lead electrocardiographic and echocardiographic data were collected prior to, during and after the procedure. Clinical follow-up was performed at 1 year.
Transfemoral implantation of the Portico valve was associated with a new PPI rate of 15.2% at 30 days and 16.7% at 1 year. Overall, 53 of the 187 patients without pre-existing LBBB developed new-onset LBBB at 1 year (28.3%); 23 occurred during the procedure. At 30 days, new-onset LBBB spontaneously resolved in 61.0% of patients. New-onset LBBB post-TAVI was not associated with new PPI (P = 0.64); 8 of the 53 patients required new PPI. Multivariable regression analyses revealed pre-existing right bundle branch block (P = 0.004) and aortic annulus diameter (P = 0.001) as independent predictors of new PPI. New PPI at discharge (n = 29) was not associated with increased freedom from all-cause (odds ratio 92.7%, 95% confidence interval 73.7-98.1%; P = 0.49) and cardiovascular (odds ratio 96.6%, 95% confidence interval 77.9-99.5%; P = 0.47) mortality at 1 year.
The Portico TAVI system demonstrated an acceptable rate of new PPI at 1 year without increased mortality risk to patients. New-onset LBBB was common during the procedure, with the majority of events spontaneously resolving by 30 days. No intraprocedural factors were shown to independently predict new PPI.
NCT01493284.
使用可重定位的自膨式 Portico™经导管主动脉瓣置换术（TAVI）系统（圣犹达医疗公司，明尼苏达州圣保罗市）评估行经导管主动脉瓣置换术（TAVI）患者新发左束支传导阻滞（LBBB）和新永久起搏器植入（PPI）的发生率和时间。还评估了与新发 PPI 相关的临床影响和围手术期因素。
前瞻性分析了来自 Pre-CE Mark Portico TAVI 系统研究的 198 名无先前起搏器的高危患者（83.1±4.7 岁，77.3%为女性，平均胸外科医师学会（STS）评分 5.8%）。在术前、术中和术后采集 12 导联心电图和超声心动图数据。在 1 年时进行临床随访。
经股植入 Portico 瓣膜后，30 天和 1 年时新发 PPI 率分别为 15.2%和 16.7%。总体而言，187 名无先前 LBBB 的患者中有 53 名在 1 年内新发 LBBB（28.3%）；23 例发生在手术过程中。30 天时，61.0%的新发 LBBB 患者自发缓解。TAVI 后新发 LBBB 与新发 PPI 无关（P=0.64）；53 例患者中有 8 例需要新的 PPI。多变量回归分析显示，先前存在的右束支传导阻滞（P=0.004）和主动脉瓣环直径（P=0.001）是新发 PPI 的独立预测因素。出院时新发 PPI（n=29）与全因（优势比 92.7%，95%置信区间 73.7-98.1%；P=0.49）和心血管（优势比 96.6%，95%置信区间 77.9-99.5%；P=0.47）死亡率增加无关。
Portico TAVI 系统在 1 年内的新发 PPI 发生率可接受，不会增加患者的死亡风险。在手术过程中，新发 LBBB 很常见，大多数事件在 30 天内自发缓解。没有术中因素被证明可以独立预测新发 PPI。
NCT01493284。
