Panaich Sidakpal S, Arora Shilpkumar, Badheka Apurva, Kumar Varun, Maor Elad, Raphael Claire, Deshmukh Abhishek, Reeder Guy, Eleid Mackram, Rihal Charanjit S
Department of Cardiovascular Diseases, Mayo Clinic, Rochester, Minnesota.
Department of Cardiology, Mount Sinai St Luke's Roosevelt Hospital Center, New York.
Catheter Cardiovasc Interv. 2018 May 1;91(6):1171-1181. doi: 10.1002/ccd.27366. Epub 2017 Nov 20.
There are sparse clinical data on the procedural trends, outcomes and readmission rates following FDA approval and expansion of Transcatheter mitral valve repair/MitraClip . Whether a complex new technology can be disseminated safely and quickly is controversial.
The study cohort was derived from the National Readmission Data (NRD) 2013-14. MitraClip was identified using appropriate International Classification of Diseases, 9th Revision, Clinical Modification (ICD-9-CM) codes. The primary outcome was a composite of in-hospital mortality + procedural complications. Secondary outcome included 30-day readmissions. Hierarchical two level logistic models were used to evaluate study outcomes.
Our analysis included 2003 MitraClip procedures. Overall in-hospital mortality was 3.9%. As expected, there was a significant increase in procedural volume post-FDA approval. Importantly, a corresponding downward trend in mortality and procedural complications was observed. Significant predictors of in-hospital mortality and procedural complications included the use of vasopressors (P <0.001) and hemodynamic support (P < 0.001). Higher hospital volume (≥10 MitraClips/year) was associated with lower in-hospital mortality and complications (P = 0.02). There were 304 (15.1%) 30-day readmissions, with heart failure being the most common cause of readmission. Elective procedures had lower in-hospital mortality (P < 0.001) and lower readmission rates (P = 0.011) compared with nonelective procedures.
A significant increase in MitraClip procedural volumes occurred post-FDA approval. Overall morbidity and mortality were low and trended downwards. Hospital procedure volume ≥10 cases were associated with lower mortality and overall complication rates. These data suggest a successful roll out of a very complex novel structural heart procedure.
关于经导管二尖瓣修复术/MitraClip在获得美国食品药品监督管理局（FDA）批准及应用范围扩大后的手术趋势、治疗结果和再入院率，临床数据稀少。一项复杂的新技术能否安全、快速地推广存在争议。
研究队列来自2013 - 2014年国家再入院数据（NRD）。使用适当的国际疾病分类第九版临床修订本（ICD - 9 - CM）编码识别MitraClip。主要结局是住院死亡率 + 手术并发症的综合指标。次要结局包括30天再入院情况。采用分层二级逻辑模型评估研究结果。
我们的分析纳入了2003例MitraClip手术。总体住院死亡率为3.9%。正如预期的那样，FDA批准后手术量显著增加。重要的是，观察到死亡率和手术并发症呈相应的下降趋势。住院死亡率和手术并发症的显著预测因素包括使用血管升压药（P <0.001）和血流动力学支持（P <0.001）。较高的医院手术量（≥每年10例MitraClip手术）与较低的住院死亡率和并发症相关（P = 0.02）。有304例（15.1%）患者在30天内再次入院，心力衰竭是再次入院最常见的原因。与非择期手术相比，择期手术的住院死亡率较低（P <0.001），再入院率也较低（P = 0.011）。
FDA批准后，MitraClip手术量显著增加。总体发病率和死亡率较低且呈下降趋势。医院手术量≥10例与较低的死亡率和总体并发症发生率相关。这些数据表明一项非常复杂的新型结构性心脏病手术成功推出。
