Edlinger Christoph, Bannehr Marwin, Wernly Bernhard, Kücken Tanja, Okamoto Maki, Lichtenauer Michael, Hähnel Valentin, Reiners David, Neuss Michael, Butter Christian
Department of Cardiology, Heart Center Brandenburg, Bernau/Berlin, Germany.
Brandenburg Medical School (MHB) "Theodor Fontane", Neuruppin, Germany.
Front Cardiovasc Med. 2021 Jun 18;8:671719. doi: 10.3389/fcvm.2021.671719. eCollection 2021.
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.
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 =