University Heart Center, University Hospital Zurich, Zurich, Switzerland.
Institute of Primary Care, University of Zurich, University Hospital Zurich, Zurich, Switzerland.
JACC Cardiovasc Interv. 2016 Jul 25;9(14):1487-95. doi: 10.1016/j.jcin.2016.04.038.
The aim of this study was to investigate the safety and efficacy of combining transcatheter valve replacement (TAVR) and left atrial appendage occlusion (LAAO) versus TAVR alone.
Patients with severe aortic stenosis and atrial fibrillation undergoing TAVR are at increased risk for stroke and bleeding complications.
A cohort of 52 patients undergoing concomitant TAVR and LAAO were compared with 52 patients undergoing isolated TAVR. A primary safety endpoint at 30 days, a clinical efficacy endpoint from day 30 to last follow-up, and an LAAO efficacy endpoint from the first post-interventional day to the last follow-up were chosen.
The mean age of the study population was 85 ± 5 years. The mean CHA2DS2-VASc score and HAS-BLED score were 3.9 ± 1.1 and 2.6 ± 0.9, respectively. The mean Society of Thoracic Surgeons score was 7.8 ± 5.5. The median follow-up duration of the study population was 9.4 months (range 0 to 48 months). The primary safety endpoint occurred in 10 patients in the concomitant group and in 7 patients in the isolated TAVR group (19% vs. 14%; 95% confidence interval: 0.59 to 4.06). The clinical and LAAO efficacy endpoints were achieved in 81 (79%) (75% vs. 82%; 95% confidence interval: 0.49 to 2.92) and 75 (73%) patients (69% vs. 76%; 95% confidence interval: 0.54 to 2.51), respectively.
This pilot study shows that concomitant TAVR and LAAO is feasible and seems to be safe among patients with severe aortic stenosis and atrial fibrillation. Larger trials and longer follow-up are needed to confirm the safety and efficacy of such an approach.
本研究旨在探讨行经导管主动脉瓣置换术（TAVR）联合左心耳封堵术（LAAO）与单纯 TAVR 相比的安全性和疗效。
行 TAVR 的重度主动脉瓣狭窄合并房颤患者发生卒中及出血并发症的风险增加。
选择同期行 TAVR 和 LAAO 的 52 例患者与同期单纯行 TAVR 的 52 例患者进行比较。选择 30 天内的主要安全性终点、30 天至末次随访的临床疗效终点以及首次介入后第 1 天至末次随访的 LAAO 疗效终点。
研究人群的平均年龄为 85±5 岁。平均 CHA2DS2-VASc 评分和 HAS-BLED 评分分别为 3.9±1.1 和 2.6±0.9，平均胸外科医师协会评分（STS）为 7.8±5.5。研究人群的中位随访时间为 9.4 个月（048 个月）。同期组中有 10 例患者发生主要安全性终点，单纯 TAVR 组中有 7 例患者发生主要安全性终点（19%比 14%；95%置信区间：0.594.06）。81（79%）例患者达到临床和 LAAO 疗效终点（75%比 82%；95%置信区间：0.492.92），75（73%）例患者达到 LAAO 疗效终点（69%比 76%；95%置信区间：0.542.51）。
本研究初步结果显示，对于重度主动脉瓣狭窄合并房颤患者，同期行 TAVR 和 LAAO 是可行的，似乎是安全的。需要更大规模的试验和更长时间的随访来证实这种方法的安全性和疗效。
