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直流通医疗公司与爱德华兹Sapien 3人工心脏瓣膜:关于中期安全性和死亡率的倾向匹配比较

Direct Flow Medical vs. Edwards Sapien 3 Prosthesis: A Propensity Matched Comparison on Intermediate Safety and Mortality.

作者信息

Edlinger Christoph, Bannehr Marwin, Wernly Bernhard, Kücken Tanja, Okamoto Maki, Lichtenauer Michael, Hähnel Valentin, Reiners David, Neuss Michael, Butter Christian

机构信息

Department of Cardiology, Heart Center Brandenburg, Bernau/Berlin, Germany.

Brandenburg Medical School (MHB) "Theodor Fontane", Neuruppin, Germany.

出版信息

Front Cardiovasc Med. 2021 Jun 18;8:671719. doi: 10.3389/fcvm.2021.671719. eCollection 2021.

Abstract

To compare intermediate performance and mortality rates in patients, who underwent transcatheter aortic valve implantation (TAVI) with two different types of prostheses: Edwards Sapien 3 (ES3) and Direct Flow Medical (DFM). 42 consecutive patients implanted with a DFM prosthesis for severe aortic stenosis were matched 1:1 with an equal number of patients, who received an ES3 during the same period. Primary endpoint was mortality. MACE, as a composite of all-cause death, stroke, and re-do-procedure (valve-in-valve), was defined as secondary endpoint. Moreover, we compared NYHA class, NT-proBNP-levels and the extent of restenosis. Patients were followed for 2 years. DFM patients showed echocardiographic elevated mean pressure gradients compared to ES3 patients before discharge (11.2 mmHg ± 5.3 vs. 3.5 mmHg ± 2.7; < 0.001) and upon 6-months follow-up (20.3 mmHg ± 8.8 vs. 12.3 mmHg ± 4.4; < 0.001). ES3 candidates showed superior NYHA class at follow-up ( = 0.001). Kaplan-Meier analysis revealed significantly worse survival in patients receiving a DFM prosthesis compared to ES3 (Breslow = 0.020). MACE occurred more often in DFM patients compared to ES3 (Breslow = 0.006). Patients receiving DFM valve prostheses showed worse survival and higher rates in MACE compared to ES3. Prosthesis performance regarding mean pressure gradients and patients' NYHA class also favored ES3.

摘要

为比较接受经导管主动脉瓣植入术(TAVI)的患者使用两种不同类型人工瓣膜:爱德华兹Sapien 3(ES3)和直流通医疗(DFM)的中期表现和死亡率。42例连续植入DFM人工瓣膜治疗严重主动脉瓣狭窄的患者与同期接受ES3人工瓣膜的同等数量患者进行1:1匹配。主要终点是死亡率。将全因死亡、中风和再次手术(瓣中瓣)组成的主要不良心血管事件(MACE)定义为次要终点。此外,我们比较了纽约心脏协会(NYHA)分级、N末端脑钠肽前体(NT-proBNP)水平和再狭窄程度。对患者进行了2年的随访。DFM组患者出院前(11.2 mmHg±5.3 vs. 3.5 mmHg±2.7;P<0.001)和随访6个月时(20.3 mmHg±8.8 vs. 12.3 mmHg±4.4;P<0.001)的超声心动图平均压力梯度高于ES3组患者。ES3组患者随访时NYHA分级更佳(P = 0.001)。Kaplan-Meier分析显示,接受DFM人工瓣膜的患者生存率明显低于ES3组(Breslow检验P =

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fe0a/8249849/91b8d6f3e713/fcvm-08-671719-g0001.jpg

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