Three-Year Outcomes of Transcatheter Aortic Valve Implantation in Patients With Varying Levels of Surgical Risk (from the CoreValve ADVANCE Study)

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• 作者：Marco Barbanti ; MD^a ; ^{mbarbanti83@gmail.com" class="auth_mail" title="E-mail the corresponding author} ; Molly Schiltgen ; MS^b ; Sarah Verdoliva ; MS^c ; Johan Bosmans ; MD ; PhD^d ; Sabine Bleiziffer ; MD^e ; Ulrich Gerckens ; MD^f ; Peter Wenaweser ; MD^g ; Stephen Brecker ; MD^h ; Simona Gulino ; MD^a ; Corrado Tamburino ; MD^a ; Axel Linke ; MDⁱ ; for the ADVANCE Study Investigators
• 刊名：The American Journal of Cardiology
• 出版年：2016
• 出版时间：1 March 2016
• 年：2016
• 卷：117
• 期：5
• 页码：820-827
• 全文大小：485 K

文摘

This study compared 3-year clinical outcomes of patients who underwent transcatheter aortic valve implantation with the Society of Thoracic Surgeons (STS) score ≤7% to those of patients with a score >7%. Data were drawn from the ADVANCE study, a multinational post-market clinical trial that enrolled real-world patients with severe aortic stenosis treated with the CoreValve bioprosthesis. Events were independently adjudicated using Valve Academic Research Consortium–1 definitions. A total of 996 patients were implanted: STS ≤7% (n = 697, median STS 4.3%, interquartile range 3.1% to 5.4%) and STS >7% (n = 298, median STS 9.7%, interquartile range 8.0% to 12.4%). At 3 years, the STS ≤7% group had lower rates of all-cause mortality (28.6 vs 45.9, p <0.01) and cardiovascular mortality (19.0 vs 30.2, p <0.01) than the STS >7% group. No differences were observed in cerebrovascular accidents, vascular complications, bleeding, or myocardial infarction. In patients with STS ≤7%, mortality at 3 years was higher in those with moderate or severe aortic regurgitation (AR) at discharge than in those with mild or less AR (39.9% vs 22.9%; hazard ratio 1.98; 95% confidence interval 1.37 to 2.86; p <0.01). Conversely, the severity of AR at discharge did not affect 3-year mortality in patients with STS >7% (42.9% vs 44.6%, moderate/severe vs mild/less; hazard ratio 1.04; 95% confidence interval, 0.62 to 1.75; p = 0.861; p for interaction = 0.047). In conclusion, patients with STS ≤7% had lower rates of all-cause and cardiovascular mortality at 3 years after transcatheter aortic valve implantation. Complication rates were low and stable in both groups, demonstrating the safety of this procedure for patients at various levels of surgical risk.