Grubb Kendra J, Yakubov Steven J, Nazif Tamim M, Mittal Suneet, Gada Hemal, Fraser Douglas G W, Rovin Joshua D, Khalil Ramzi, Pyo Robert T, Sharma Samin K, Ahmed Mustafa, Huang Jian, Rodes-Cabau Josep
Division of Cardiothoracic Surgery, Emory University, Atlanta, Georgia.
Department of Interventional Cardiology, Riverside Methodist-OhioHealth, Columbus, Ohio.
J Soc Cardiovasc Angiogr Interv. 2023 Nov 3;3(1):101066. doi: 10.1016/j.jscai.2023.101066. eCollection 2024 Jan.
Lack of standardization in posttranscatheter aortic valve replacement (TAVR) conduction disturbance (CD) identification and treatment may affect permanent pacemaker implantation (PPI) rates and clinical outcomes. The safety and efficacy of a standardized TAVR CD algorithm has not been analyzed. This study analyzes the Optimize PRO post-TAVR CD management algorithm with Evolut PRO/PRO valves.
Optimize PRO is a prospective, postmarket study implementing 2 strategies to reduce pacemaker rates: TAVR with cusp overlap technique and a post-TAVR CD algorithm. The 2-hour postprocedural electrocardiogram (ECG) stratified patients to early discharge in the absence of new ECG changes or to CD algorithms for (1) ECG changes with preexisting right or left bundle branch block (LBBB), interventricular conduction delay or first-degree atrioventricular block, (2) new LBBB, or (3) high-degree atrioventricular block (HAVB).
The interim analysis of the CD cohort consisted of 125/400 TAVR recipients. In the CD cohort, the 30-day new PPI rate was higher (28.1% vs 1.5%; <.001), and 60 (48%) patients were discharged with a 30-day continuous ECG monitor. At 30 days, 90% of patients discharged with a monitor did not require PPI. Clinical outcomes, including mortality, stroke, bleeding, and reintervention, were similar in patients with and without CDs. No patient experienced sudden cardiac death.
Effective management of CDs using a standard algorithm following Evolut TAVR provides similar 30-day safety outcomes to patients without CDs who undergo routine next day discharge. The CD algorithm may provide an effective strategy to recognize arrhythmias early, improve PPI utilization, and facilitate safe monitoring of patients after discharge.
经导管主动脉瓣置换术(TAVR)后传导障碍(CD)的识别与治疗缺乏标准化,可能会影响永久起搏器植入(PPI)率及临床结局。目前尚未分析标准化TAVR CD算法的安全性和有效性。本研究分析了使用Evolut PRO/PRO瓣膜的Optimize PRO TAVR术后CD管理算法。
Optimize PRO是一项上市后前瞻性研究,实施了两种降低起搏器使用率的策略:采用瓣叶重叠技术的TAVR和TAVR术后CD算法。术后2小时心电图(ECG)将患者分层,若没有新的ECG变化则可早期出院,若出现以下情况则采用CD算法:(1)伴有既往右束支或左束支传导阻滞(LBBB)、室内传导延迟或一度房室传导阻滞的ECG变化;(2)新发LBBB;或(3)高度房室传导阻滞(HAVB)。
CD队列的中期分析纳入了400例TAVR接受者中的125例。在CD队列中,30天新PPI率更高(28.1%对1.5%;P<0.001),60例(48%)患者出院时佩戴30天连续ECG监测仪。在30天时,90%佩戴监测仪出院的患者不需要植入PPI。有CD和无CD患者的临床结局,包括死亡率、中风、出血和再次干预,相似。没有患者发生心源性猝死。
Evolut TAVR术后使用标准算法有效管理CD,为术后次日常规出院的无CD患者提供了相似的30天安全性结局。CD算法可能提供一种有效的策略,用于早期识别心律失常、提高PPI利用率,并便于出院后对患者进行安全监测。