Abstract：
BACKGROUND: 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.
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: 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.
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: 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.
摘要：
背景：在经导管瓣膜介入治疗的时代，生物外科二尖瓣置换术（SMVR）仍然是一种重要的治疗选择。我们介绍了使用当代低调二尖瓣猪瓣膜进行SMVR的Medicare受益人的10年临床结果。
方法：这是一项使用Medicare按服务收费索赔数据的单臂观察性研究。使用Epic™二尖瓣接受SMVR的去识别患者（Abbott，明尼苏达,美国）在美国2008年1月1日至2019年12月31日之间由ICD-9/10程序代码选择，然后链接到制造商设备跟踪数据库。全因死亡率,心力衰竭（HF）再次住院，使用KaplanMeier方法在10年时评估了二尖瓣再介入治疗(手术或经导管瓣膜).
结果：在研究期间接受SMVR的75,739名Medicare受益人中，14,015例植入了Epic™二尖瓣,其中76.5%(10,720)有潜在的HF。平均年龄74±8岁。术前无HF患者的10年生存率为40.4%（95%CI37.4%-43.4%），而HF患者为25.4%（95%CI23.8%-27.0%）（p<0.001）。HF再住院的10年自由度为51.3％（95％CI49.4％-53.1％）。10年时，二尖瓣再介入的自由度为91.4％（95％CI89.7％-92.7％）。
结论：这项针对接受Epic™二尖瓣的Medicare受益人的全国现实研究表明，在植入后10年，无90％的全因瓣膜再干预和无50％的HF再住院。发现患有二尖瓣疾病并接受SMVR的人群的长期生存和HF再住院受到潜在HF的影响。
方法：这是一项使用Medicare按服务收费索赔数据的单臂观察性研究。使用Epic™二尖瓣接受SMVR的去识别患者（Abbott，明尼苏达,美国）在美国2008年1月1日至2019年12月31日之间由ICD-9/10程序代码选择，然后链接到制造商设备跟踪数据库。全因死亡率,心力衰竭（HF）再次住院，使用KaplanMeier方法在10年时评估了二尖瓣再介入治疗(手术或经导管瓣膜).
结果：在研究期间接受SMVR的75,739名Medicare受益人中，14,015例植入了Epic™二尖瓣,其中76.5%(10,720)有潜在的HF。平均年龄74±8岁。术前无HF患者的10年生存率为40.4%（95%CI37.4%-43.4%），而HF患者为25.4%（95%CI23.8%-27.0%）（p<0.001）。HF再住院的10年自由度为51.3％（95％CI49.4％-53.1％）。10年时，二尖瓣再介入的自由度为91.4％（95％CI89.7％-92.7％）。
结论：这项针对接受Epic™二尖瓣的Medicare受益人的全国现实研究表明，在植入后10年，无90％的全因瓣膜再干预和无50％的HF再住院。发现患有二尖瓣疾病并接受SMVR的人群的长期生存和HF再住院受到潜在HF的影响。
