Wiechmann Robert J, Lee Leonard Y, Yu Yang, Prillinger Julie B, Gutfinger Dan, Blakeman Bradford
Mayo Clinic Health System, Cardiothoracic Surgery, Eau Claire, Wis.
Division of Cardiothoracic Surgery, Rutgers Robert Wood Johnson Medical School, New Brunswick, NJ.
JTCVS Open. 2022 Aug 17;12:84-102. doi: 10.1016/j.xjon.2022.08.002. eCollection 2022 Dec.
Bioprosthetic surgical aortic valve replacement remains an important treatment option in the era of transcatheter interventions. Real-world outcomes are not well characterized because of limited prospective follow-up studies. We present the 10-year clinical outcomes of Medicare beneficiaries undergoing surgical aortic valve replacement with a contemporary supra-annular porcine valve.
This is a single-arm observational study using Medicare fee-for-service claims data. De-identified patients undergoing surgical aortic valve replacement with the Epic Supra valve (Abbott) in the United States between January 1, 2008, and December 31, 2019, were selected by International Classification of Diseases 9 and 10 Revision procedure codes and then linked to a manufacturer device tracking database. All-cause mortality, heart failure rehospitalization, and aortic valve reintervention (surgical or transcatheter valve-in-valve) were evaluated at 10 years using the Kaplan-Meier method.
Among 272,591 Medicare beneficiaries undergoing surgical aortic valve replacement during the study period, 11,685 received the Epic Supra valve, of whom 51.6% (6029) had underlying heart failure. Mean age was 76 ± 7 years. Survival at 10 years in patients without preoperative heart failure was 43.5% (95% confidence interval, 41.8-45.2) compared with 24.1% (95% confidence interval, 22.6-25.5) for patients with heart failure ( < .001). The 10-year freedom from heart failure rehospitalization was 64.0% (95% confidence interval, 62.6-65.3). Freedom from aortic valve reintervention was 94.6% (95% confidence interval, 93.8-95.3) at 10 years.
This real-world nationwide study of US Medicare beneficiaries receiving the Epic Supra valve demonstrates more than 94% freedom from all-cause valve reintervention and 64% freedom from heart failure rehospitalization at 10 years postimplant. Long-term survival and heart failure rehospitalization in this population with aortic valve disease undergoing surgical aortic valve replacement were found to be impacted by underlying heart failure.
在经导管介入治疗时代，生物人工心脏主动脉瓣置换术仍是一种重要的治疗选择。由于前瞻性随访研究有限，真实世界的结果尚未得到充分描述。我们展示了接受当代超环猪主动脉瓣置换术的医疗保险受益人的10年临床结果。
这是一项使用医疗保险按服务收费索赔数据的单臂观察性研究。通过国际疾病分类第9版和第10版修订程序代码，选择2008年1月1日至2019年12月31日期间在美国接受Epic Supra瓣膜（雅培公司）主动脉瓣置换术的身份不明患者，然后将其与制造商设备跟踪数据库相链接。使用Kaplan-Meier方法在10年时评估全因死亡率、心力衰竭再住院率和主动脉瓣再次干预（手术或经导管瓣中瓣）情况。
在研究期间接受主动脉瓣置换术的272,591名医疗保险受益人中，11,685人接受了Epic Supra瓣膜，其中51.6%（6029人）有潜在心力衰竭。平均年龄为76±7岁。术前无心力衰竭患者的10年生存率为43.5%（95%置信区间，41.8 - 45.2），而有心力衰竭患者为24.1%（95%置信区间，22.6 - 25.5）（P <.001）。10年无心力衰竭再住院率为64.0%（95%置信区间，62.6 - 65.3）。10年无主动脉瓣再次干预率为94.6%（95%置信区间，93.8 - 95.3）。
这项针对接受Epic Supra瓣膜的美国医疗保险受益人的全国性真实世界研究表明，植入后10年全因瓣膜再次干预率超过94%，心力衰竭再住院率为64%。发现该患有主动脉瓣疾病并接受手术主动脉瓣置换术的人群的长期生存和心力衰竭再住院情况受潜在心力衰竭的影响。
