Department of Cardiac Surgery, University of Michigan, Ann Arbor, Michigan.
Department of Internal Medicine, Division of Cardiology, University of Michigan, Ann Arbor, Michigan.
JACC Cardiovasc Interv. 2017 May 22;10(10):1034-1044. doi: 10.1016/j.jcin.2017.03.018.
OBJECTIVES: This study evaluated the safety and effectiveness of self-expanding transcatheter aortic valve replacement (TAVR) in patients with surgical valve failure (SVF). BACKGROUND: Self-expanding TAVR is superior to medical therapy for patients with severe native aortic valve stenosis at increased surgical risk. METHODS: The CoreValve U.S. Expanded Use Study was a prospective, nonrandomized study that enrolled 233 patients with symptomatic SVF who were deemed unsuitable for reoperation. Patients were treated with self-expanding TAVR and evaluated for 30-day and 1-year outcomes after the procedure. An independent core laboratory was used to evaluate serial echocardiograms for valve hemodynamics and aortic regurgitation. RESULTS: SVF occurred through stenosis (56.4%), regurgitation (22.0%), or a combination (21.6%). A total of 227 patients underwent attempted TAVR and successful TAVR was achieved in 225 (99.1%) patients. Patients were elderly (76.7 ± 10.8 years), had a Society of Thoracic Surgeons Predicted Risk of Mortality score of 9.0 ± 6.7%, and were severely symptomatic (86.8% New York Heart Association functional class III or IV). The all-cause mortality rate was 2.2% at 30 days and 14.6% at 1 year; major stroke rate was 0.4% at 30 days and 1.8% at 1 year. Moderate aortic regurgitation occurred in 3.5% of patients at 30 days and 7.4% of patients at 1 year, with no severe aortic regurgitation. The rate of new permanent pacemaker implantation was 8.1% at 30 days and 11.0% at 1 year. The mean valve gradient was 17.0 ± 8.8 mm Hg at 30 days and 16.6 ± 8.9 mm Hg at 1 year. Factors significantly associated with higher discharge mean aortic gradients were surgical valve size, stenosis as modality of SVF, and presence of surgical valve prosthesis patient mismatch (all p < 0.001). CONCLUSIONS: Self-expanding TAVR in patients with SVF at increased risk for surgery was associated with a low 1-year mortality and major stroke rate, significantly improved aortic valve hemodynamics, and low rates of moderate and no severe residual aortic regurgitation, with improved quality of life.
目的：本研究评估了自膨式经导管主动脉瓣置换术（TAVR）在外科瓣膜失功（SVF）患者中的安全性和有效性。
背景：对于手术风险增加的严重原发性主动脉瓣狭窄患者，自膨式 TAVR 优于药物治疗。
方法：CoreValve 美国扩展使用研究是一项前瞻性、非随机研究，共纳入 233 例因手术风险高而被认为不适合再次手术的有症状 SVF 患者。对这些患者采用自膨式 TAVR 进行治疗，并在术后 30 天和 1 年时评估其结局。采用独立的核心实验室对连续超声心动图的瓣膜血流动力学和主动脉瓣反流情况进行评估。
结果：SVF 的病因包括狭窄（56.4%）、反流（22.0%）或二者兼有（21.6%）。共有 227 例患者尝试进行 TAVR，225 例（99.1%）患者成功完成 TAVR。患者年龄较大（76.7±10.8 岁），胸外科医生协会预测死亡率评分（STS 评分）为 9.0±6.7%，且症状严重（86.8%为纽约心脏协会心功能 III 或 IV 级）。30 天时全因死亡率为 2.2%，1 年时为 14.6%；30 天时主要脑卒中发生率为 0.4%，1 年时为 1.8%。30 天时，3.5%的患者出现中度主动脉瓣反流，1 年时，7.4%的患者出现中度主动脉瓣反流，无严重主动脉瓣反流。30 天时新植入永久性起搏器的发生率为 8.1%，1 年时为 11.0%。30 天时平均瓣口梯度为 17.0±8.8mmHg，1 年时为 16.6±8.9mmHg。与出院时平均主动脉瓣梯度较高显著相关的因素包括外科瓣膜尺寸、SVF 的狭窄模式以及外科瓣膜假体患者不匹配（均 p<0.001）。
结论：对于手术风险增加的 SVF 患者，采用自膨式 TAVR 治疗，1 年死亡率和主要脑卒中发生率较低，主动脉瓣血流动力学显著改善，中度和无严重残余主动脉瓣反流的发生率较低，生活质量提高。
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