Schaefer Ulrich, Zahn Ralf, Abdel-Wahab Mohamed, Gerckens Ulrich, Linke Axel, Schneider Steffen, Eggebrecht Holger, Sievert Horst, Figulla Hans Reiner, Senges Jochen, Kuck Karl Heinz
Department of Cardiology, Asklepios Clinics Sankt Georg, Hamburg, Germany; Department of Cardiology, University Heart Center Eppendorf, Hamburg, Germany.
Department of Cardiology, Heart Center Ludwigshafen, Ludwigshafen, Germany.
Am J Cardiol. 2015 Mar 1;115(5):656-63. doi: 10.1016/j.amjcard.2014.12.019. Epub 2014 Dec 18.
Transcatheter aortic valve implantation (TAVI) is rapidly evolving in Germany. Especially severe reduced left ventricular ejection fraction (LVEF) is known as a prominent risk factor for adverse outcome in open heart surgery. Thus, the data of the prospective multicenter German Transcatheter Aortic Valve Interventions Registry were analyzed for outcomes in patients with severe depressed LVEF. Data of 1,432 patients were consecutively collected after transcatheter aortic valve implantation. Patients were divided into 2 groups (A: LVEF ≤30%, n = 169, age 79.9 ± 6.7 years, logES 34.2 ± 17.8%; B: LVEF >30%, n = 1,263, age 82.0 ± 6.1 years, logES 18.9 ± 12.0%), and procedural success rates, New York Heart Association classification, and quality of life were compared at 30 days and 1 year, respectively. Technical success was achieved in 95.9% (A) and 97.6% (B). Survival and the New York Heart Association classification at 30 days demonstrated an excellent outcome in both groups. There was a significant improvement according to the self-assessment in health condition (0 to 100 scale) with a much larger gain in group A (28 vs 19 patients, p <0.0001). Nevertheless, low cardiac output syndrome (12.3% vs 5.9%, p <0.01) and resuscitation (10.4% vs 5.6%, p <0.05) were more frequently seen in group A, contributing to a higher mortality at 30 days (14.3% vs 7.2%) and 1 year (33.7% vs 18.1%, p <0.001). In conclusion, this real-world registry demonstrated a comparably high success rate for patients with severe reduced LVEF and an early improvement in functional status as demonstrated by substantial benefit, despite a doubled postprocedural mortality.
经导管主动脉瓣植入术（TAVI）在德国正迅速发展。尤其是严重降低的左心室射血分数（LVEF）是心脏直视手术不良预后的一个突出危险因素。因此，对德国前瞻性多中心经导管主动脉瓣干预注册研究的数据进行了分析，以了解严重LVEF降低患者的预后情况。在经导管主动脉瓣植入术后连续收集了1432例患者的数据。患者分为两组（A组：LVEF≤30%，n = 169，年龄79.9±6.7岁，logES 34.2±17.8%；B组：LVEF>30%，n = 1263，年龄82.0±6.1岁，logES 18.9±12.0%），并分别比较了30天和1年时的手术成功率、纽约心脏协会分级和生活质量。A组技术成功率为95.9%，B组为97.6%。两组在30天时的生存率和纽约心脏协会分级均显示出良好的预后。根据健康状况的自我评估（0至100分制）有显著改善，A组改善幅度更大（28例对19例，p<0.0001）。然而，A组更频繁出现低心排血量综合征（12.3%对5.9%，p<0.01）和复苏情况（10.4%对5.6%，p<0.05），导致30天时死亡率更高（14.3%对7.2%），1年时死亡率也更高（33.7%对18.1%，p<0.001）。总之，这项真实世界注册研究表明，尽管术后死亡率翻倍，但严重LVEF降低的患者手术成功率相对较高，且功能状态有早期改善，表现为有显著益处。
