From Department of Cardiology, Heart Center Bonn, University Hospital Bonn, Germany (G.N., C.H., R.S.); Heart Center Osnabrück-Bad Rothenfelde, Schüchterman Klinik, Bad Rothenfelde, Germany (M.K.); Department of Cardiology, Ludwig- Maximilians University Munich, Germany (J.H., D.B.); Hamburg Universitary Cardiovascular Center, Germany (J.S., E.Y.); Heart Center, University of Cologne, Germany (V.R., K.F.); Department of Cardiac and Vascular Surgery, University Hospital Zürich, Switzerland (F.M., M.T.); Department of Interventional Cardiology, St. Michael's Hospital, Toronto, Canada (N.F.); Department of Cardiology, Policlinico San Donato, Milan, Italy (G.B., F.B.); Department of Cardiac Surgery, Ospedale San Raffaele, Milan, Italy (P.D., O.A.); and Department of Interventional Cardiology, Ospedale San Raffaele Milano, Milan, Italy (A.L., A.C.).
Circulation. 2017 May 9;135(19):1802-1814. doi: 10.1161/CIRCULATIONAHA.116.024848. Epub 2017 Mar 23.
BACKGROUND: Current surgical and medical treatment options for severe tricuspid regurgitation (TR) are limited, and additional interventional approaches are required. In the present observational study, the safety and feasibility of transcatheter repair of chronic severe TR with the MitraClip system were evaluated. In addition, the effects on clinical symptoms were assessed. METHODS: Patients with heart failure symptoms and severe TR on optimal medical treatment were treated with the MitraClip system. Safety, defined as periprocedural adverse events such as death, myocardial infarction, stroke, or cardiac tamponade, and feasibility, defined as successful implantation of 1 or more MitraClip devices and reduction of TR by at least 1 grade, were evaluated before discharge and after 30 days. In addition, functional outcome, defined as changes in New York Heart Assocation class and 6-minute walking distance, were assessed. RESULTS: We included 64 consecutive patients (mean age 76.6±10 years) deemed unsuitable for surgery who underwent MitraClip treatment for chronic, severe TR for compassionate use. Functional TR was present in 88%; in addition, 22 patients were also treated with the MitraClip system for mitral regurgitation as a combined procedure. The degree of TR was severe or massive in 88% of patients before the procedure. The MitraClip device was successfully implanted in the tricuspid valve in 97% of the cases. After the procedure, TR was reduced by at least 1 grade in 91% of the patients, thereof 4% that were reduced from massive to severe. In 13% of patients, TR remained severe after the procedure. Significant reductions in effective regurgitant orifice area (0.9±0.3cm versus 0.4±0.2cm; <0.001), vena contracta width (1.1±0.5 cm versus 0.6±0.3 cm; =0.001), and regurgitant volume (57.2±12.8 mL/beat versus 30.8±6.9 mL/beat; <0.001) were observed. No intraprocedural deaths, cardiac tamponade, emergency surgery, stroke, myocardial infarction, or major vascular complications occurred. Three (5%) in-hospital deaths occurred. New York Heart Association class was significantly improved (<0.001), and 6-minute walking distance increased significantly (165.9±102.5 m versus 193.5±115.9 m; =0.007). CONCLUSIONS: Transcatheter treatment of TR with the MitraClip system seems to be safe and feasible in this cohort of preselected patients. Initial efficacy analysis showed encouraging reduction of TR, which may potentially result in improved clinical outcomes.
背景：目前，治疗严重三尖瓣反流（TR）的手术和医疗方法有限，需要额外的介入方法。在本观察性研究中，评估了经导管修复慢性严重 TR 应用 MitraClip 系统的安全性和可行性。此外，还评估了对临床症状的影响。
方法：对接受最佳药物治疗后出现心力衰竭症状和严重 TR 的患者应用 MitraClip 系统进行治疗。安全性定义为围手术期不良事件，如死亡、心肌梗死、卒中和心脏压塞；可行性定义为成功植入 1 个或多个 MitraClip 装置以及 TR 至少降低 1 个等级。在出院前和 30 天后评估安全性和可行性。此外，还评估了功能结局，定义为纽约心功能协会（NYHA）分级和 6 分钟步行距离的变化。
结果：我们纳入了 64 例因不适合手术而被认为不适合手术的连续患者（平均年龄 76.6±10 岁），因同情使用原因接受 MitraClip 治疗慢性严重 TR。功能性 TR 存在于 88%的患者中；此外，22 例患者还因二尖瓣反流接受 MitraClip 系统治疗作为联合手术。88%的患者在术前 TR 严重或大量反流。MitraClip 装置在 97%的情况下成功植入三尖瓣。术后，91%的患者 TR 至少降低 1 个等级，其中 4%的患者从大量反流降低为严重反流。术后 13%的患者 TR 仍严重。有效反流瓣口面积（0.9±0.3cm 比 0.4±0.2cm；<0.001）、收缩期瓣环宽度（1.1±0.5cm 比 0.6±0.3cm；=0.001）和反流容积（57.2±12.8mL/beat 比 30.8±6.9mL/beat；<0.001）显著降低。术中无死亡、心脏压塞、紧急手术、卒中和心肌梗死，或大血管并发症发生。3 例（5%）院内死亡。纽约心功能协会（NYHA）分级显著改善（<0.001），6 分钟步行距离显著增加（165.9±102.5m 比 193.5±115.9m；=0.007）。
结论：在这组预先选择的患者中，经导管应用 MitraClip 系统治疗 TR 似乎是安全且可行的。初步疗效分析显示 TR 明显降低，这可能会带来临床结局的改善。
Eur Heart J. 2016-1-7
J Am Coll Cardiol. 2019-4-23
JACC Cardiovasc Interv. 2017-10-9
Turk Kardiyol Dern Ars. 2024-9
JACC Cardiovasc Interv. 2020-9-28
J Cardiovasc Dev Dis. 2025-7-31
Rev Cardiovasc Med. 2025-5-8
Rev Cardiovasc Med. 2025-3-5
Eur Heart J Imaging Methods Pract. 2025-1-29
J Mech Behav Biomed Mater. 2025-3
US Cardiol. 2021-6-30
Interv Cardiol. 2024-10-28
Zotero 插件