Valve Science Center, Minneapolis Heart Institute Foundation, Abbott Northwestern Hospital, Minneapolis, Minnesota.
Duke Clinical Research Institute, Duke University Medical Center, Durham, North Carolina.
J Am Coll Cardiol. 2017 Nov 7;70(19):2315-2327. doi: 10.1016/j.jacc.2017.09.015.
Post-market surveillance is needed to evaluate the real-world clinical effectiveness and safety of U.S. Food and Drug Administration-approved devices.
The authors examined the commercial experience with transcatheter mitral valve repair for the treatment of mitral regurgitation.
Data from the Society of Thoracic Surgery/American College of Cardiology Transcatheter Valve Therapy Registry on patients commercially treated with transcatheter mitral valve repair were analyzed. The study population consisted of 2,952 patients treated at 145 hospitals between November 2013 and September 2015. In 1,867 patients, data were linked to patient-specific Centers for Medicare and Medicaid Services administrative claims for analyses.
The median age was 82 years (55.8% men), with a median Society of Thoracic Surgery predicted risk of mortality of 6.1% (interquartile range: 3.7% to 9.9%) and 9.2% (interquartile range: 6.0% to 14.1%) for mitral repair and replacement, respectively. Overall, in-hospital mortality was 2.7%. Acute procedure success occurred in 91.8%. Among the patients with Centers for Medicare and Medicaid Services linkage data, the mortality at 30 days and at 1 year was 5.2% and 25.8%, respectively, and repeat hospitalization for heart failure at 1 year occurred in 20.2%. Variables associated with mortality or rehospitalization for heart failure after multivariate adjustment were increasing age, lower baseline left ventricular ejection fraction, worse post-procedural mitral regurgitation, moderate or severe lung disease, dialysis, and severe tricuspid regurgitation.
Our findings demonstrate that commercial transcatheter mitral valve repair is being performed in the United States with acute effectiveness and safety. Our findings may help determine which patients have favorable long-term outcomes with this therapy.
需要进行上市后监测，以评估美国食品和药物管理局批准的器械的真实世界临床疗效和安全性。
作者研究了经导管二尖瓣修复治疗二尖瓣反流的商业经验。
分析了美国胸外科医师学会/美国心脏病学会经导管瓣膜治疗登记处中接受经导管二尖瓣修复商业治疗的患者数据。研究人群包括 2013 年 11 月至 2015 年 9 月在 145 家医院接受治疗的 2952 例患者。在 1867 例患者中，数据与患者特定的医疗保险和医疗补助服务管理索赔相关联，以便进行分析。
中位年龄为 82 岁（55.8%为男性），胸外科医师学会预测死亡率中位数为 6.1%（四分位距：3.7%至 9.9%），二尖瓣修复和置换的中位数分别为 9.2%（四分位距：6.0%至 14.1%）。总体而言，院内死亡率为 2.7%。急性手术成功率为 91.8%。在有医疗保险和医疗补助服务相关联数据的患者中，30 天死亡率和 1 年死亡率分别为 5.2%和 25.8%，1 年后因心力衰竭再次住院的比例为 20.2%。多变量调整后与死亡率或心力衰竭再住院相关的变量包括年龄增加、左心室射血分数降低、术后二尖瓣反流加重、中度或重度肺部疾病、透析和重度三尖瓣反流。
我们的研究结果表明，经导管二尖瓣修复在美国已商业化开展，其急性疗效和安全性良好。我们的研究结果可能有助于确定哪些患者长期接受这种治疗具有良好的效果。
