Rodriguez Evelio, Smith Robert, Castro Luis, Baker Craig J, Yu Yang, Prillinger Julie B, Gutfinger Dan, Starnes Vaughn A
Department of Cardiac Surgery, Ascension Saint Thomas Hospital, Nashville, Tennessee.
Division of Cardiothoracic Surgery, Baylor Scott & White The Heart Hospital, Plano, Texas.
Ann Thorac Surg. 2025 May;119(5):1027-1035. doi: 10.1016/j.athoracsur.2024.07.032. Epub 2024 Aug 14.
Bioprosthetic surgical mitral valve replacement (SMVR) remains an important treatment option in the era of transcatheter valve interventions. This study presents 10-year clinical outcomes of Medicare beneficiaries who underwent SMVR with a contemporary low-profile mitral porcine valve.
This was a single-arm observational study using Medicare fee-for-service claims data. Deidentified patients undergoing SMVR with the Epic mitral valve (Abbott) in the United States between January 1, 2008 and December 31, 2019 were selected by International Classification of Diseases, Ninth and Tenth Revision procedure codes and then linked to a manufacturer device tracking database. All-cause mortality, heart failure (HF) rehospitalization, and mitral valve reintervention (surgical or transcatheter valve-in-valve) were evaluated at 10 years by using the Kaplan-Meier method.
Among 75,739 Medicare beneficiaries undergoing SMVR during the study period, 14,015 received the Epic mitral valve (Abbott), 76.5% (10,720) of whom had underlying HF. The mean age was 74 ± 8 years. Survival at 10 years in patients without preoperative HF was 40.4% (95% CI, 37.4%-43.4%) compared with 25.4% (95% CI ,23.8%-27.0%) for patients with HF (P < .001). The 10-year freedom from HF rehospitalization was 51.3% (95% CI, 49.4%-53.1%). Freedom from mitral valve reintervention was 91.4% (95% CI, 89.7%-92.7%) at 10 years.
This real-world nationwide study of Medicare beneficiaries receiving the Epic mitral valve demonstrates >90% freedom from all-cause valve reintervention and >50% freedom from HF rehospitalization at 10 years after implantation. Long-term survival and HF rehospitalization in this population with mitral valve disease treated with SMVR was found to be affected by underlying HF.
在经导管瓣膜介入治疗时代，生物人工心脏二尖瓣置换术（SMVR）仍是一种重要的治疗选择。本研究展示了接受当代低调猪二尖瓣进行SMVR的医疗保险受益人的10年临床结局。
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九版和第十版程序代码，选择2008年1月1日至2019年12月31日期间在美国接受Epic二尖瓣（雅培公司）进行SMVR的身份信息已去识别化的患者，然后将其与制造商设备追踪数据库相链接。使用Kaplan-Meier方法在10年时评估全因死亡率、心力衰竭（HF）再住院率和二尖瓣再次干预（手术或经导管瓣中瓣）情况。
在研究期间接受SMVR的75,739名医疗保险受益人中，14,015人接受了Epic二尖瓣（雅培公司），其中76.5%（10,720人）有潜在HF。平均年龄为74±8岁。术前无HF患者的10年生存率为40.4%（95%CI，37.4%-43.4%），而有HF患者为25.4%（95%CI，23.8%-27.0%）（P<.001）。10年无HF再住院率为51.3%（95%CI，49.4%-53.1%）。10年无二尖瓣再次干预率为91.4%（95%CI，89.7%-92.7%）。
这项针对接受Epic二尖瓣的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>90%，HF再住院率>50%。发现接受SMVR治疗的该二尖瓣疾病人群的长期生存和HF再住院受潜在HF影响。
