同期三尖瓣修复术治疗退行性二尖瓣反流患者。
Concomitant Tricuspid Repair in Patients with Degenerative Mitral Regurgitation.
机构信息
From the Division of Cardiac Surgery, Johns Hopkins School of Medicine, Baltimore (J.S.G.), and the Division of Cardiovascular Sciences (M.A.M., W.C.T.-P.), National Heart, Lung, and Blood Institute (N.O.J.), National Institutes of Health, Bethesda - both in Maryland; the Division of Cardiac Surgery, Western University, London Health Sciences Centre, London, ON (M.W.A.C.), and the Division of Cardiovascular Surgery, Toronto General Hospital and University of Toronto, Toronto (R.W.), Institut Universitaire de Cardiologie et de Pneumologie de Québec, Quebec, QC (P.V.), and Cardiovascular and Thoracic Surgery, Department of Surgery, University of Alberta, Edmonton (J.C.M.) - all in Canada; the Department of Cardiothoracic and Vascular Surgery, Deutsche Herzzentrum Berlin, the Department of Cardiovascular Surgery, Charité Universitätsmedizin Berlin, and DZHK (German Center for Cardiovascular Research), Berlin (V.F.), Technical University of Munich, School of Medicine and Health, the Department of Cardiovascular Surgery, Institute Insure (Institute for Translational Cardiac Surgery), German Heart Center Munich, and DZHK, Munich (M.K.), the Department of Cardiovascular Surgery, University Heart Center Hamburg, Hamburg (L.C.), the Department of Cardiovascular Surgery, University Heart Center Freiburg, and Albert Ludwigs University Freiburg, Freiburg (F.B.), and Leipzig Heart Center, University of Leipzig, Leipzig (M.A.B.) - all in Germany; the Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai (J.R.O., A.J.M., E.A.R., S.R., E.G.M., K.O., M.E.M., E.B., A.C.G.) and the Department of Cardiothoracic and Vascular Surgery, Montefiore Medical Center, Albert Einstein College of Medicine (M.K.P.) - both in New York; the Department of Thoracic and Cardiovascular Surgery, Cleveland Clinic, Cleveland (M.G.); the Department of Cardiac and Thoracic Surgery, Baylor Scott and White Health, Plano (M.J.M.), and American Heart Association, Dallas (M.J.) - both in Texas; the Department of Surgery, Division of Cardiac Surgery, Yale School of Medicine, New Haven, CT (A.G., M.K.); the Division of Cardiovascular and Thoracic Surgery, Department of Surgery, Duke University, Durham, NC (B.Y.); the Departments of Surgery and Population and Public Health Sciences, Keck School of Medicine, University of Southern California, Los Angeles (M.E.B.); the Department of Cardiac Surgery, University of Michigan Health System, Ann Arbor (S.F.B., G.A.); the Section of Cardiac Surgery, Dartmouth-Hitchcock Medical Center, Lebanon, NH (A.I.); and the Division of Cardiology, Massachusetts General Hospital (J.H.) and the Division of Cardiovascular Medicine, Brigham and Women's Hospital (P.T.O.) - both in Boston.
出版信息
N Engl J Med. 2022 Jan 27;386(4):327-339. doi: 10.1056/NEJMoa2115961. Epub 2021 Nov 13.
BACKGROUND
Tricuspid regurgitation is common in patients with severe degenerative mitral regurgitation. However, the evidence base is insufficient to inform a decision about whether to perform tricuspid-valve repair during mitral-valve surgery in patients who have moderate tricuspid regurgitation or less-than-moderate regurgitation with annular dilatation.
METHODS
We randomly assigned 401 patients who were undergoing mitral-valve surgery for degenerative mitral regurgitation to receive a procedure with or without tricuspid annuloplasty (TA). The primary 2-year end point was a composite of reoperation for tricuspid regurgitation, progression of tricuspid regurgitation by two grades from baseline or the presence of severe tricuspid regurgitation, or death.
RESULTS
Patients who underwent mitral-valve surgery plus TA had fewer primary-end-point events than those who underwent mitral-valve surgery alone (3.9% vs. 10.2%) (relative risk, 0.37; 95% confidence interval [CI], 0.16 to 0.86; P = 0.02). Two-year mortality was 3.2% in the surgery-plus-TA group and 4.5% in the surgery-alone group (relative risk, 0.69; 95% CI, 0.25 to 1.88). The 2-year prevalence of progression of tricuspid regurgitation was lower in the surgery-plus-TA group than in the surgery-alone group (0.6% vs. 6.1%; relative risk, 0.09; 95% CI, 0.01 to 0.69). The frequencies of major adverse cardiac and cerebrovascular events, functional status, and quality of life were similar in the two groups at 2 years, although the incidence of permanent pacemaker implantation was higher in the surgery-plus-TA group than in the surgery-alone group (14.1% vs. 2.5%; rate ratio, 5.75; 95% CI, 2.27 to 14.60).
CONCLUSIONS
Among patients undergoing mitral-valve surgery, those who also received TA had a lower incidence of a primary-end-point event than those who underwent mitral-valve surgery alone at 2 years, a reduction that was driven by less frequent progression to severe tricuspid regurgitation. Tricuspid repair resulted in more frequent permanent pacemaker implantation. Whether reduced progression of tricuspid regurgitation results in long-term clinical benefit can be determined only with longer follow-up. (Funded by the National Heart, Lung, and Blood Institute and the German Center for Cardiovascular Research; ClinicalTrials.gov number, NCT02675244.).
背景
三尖瓣反流在严重退行性二尖瓣反流患者中很常见。然而，证据基础不足以告知在中重度或轻中度三尖瓣反流伴瓣环扩张的患者中进行二尖瓣手术时是否进行三尖瓣瓣环修复的决策。
方法
我们随机分配了 401 名因退行性二尖瓣反流而行二尖瓣手术的患者，接受或不接受三尖瓣环成形术（TA）。主要的 2 年终点是三尖瓣反流再手术、三尖瓣反流从基线增加两级或出现严重三尖瓣反流或死亡的复合终点。
结果
接受二尖瓣手术加 TA 的患者比仅接受二尖瓣手术的患者主要终点事件更少（3.9%比 10.2%）（相对风险，0.37；95%置信区间[CI]，0.16 至 0.86；P=0.02）。手术加 TA 组的 2 年死亡率为 3.2%，手术组为 4.5%（相对风险，0.69；95%CI，0.25 至 1.88）。手术加 TA 组的 2 年三尖瓣反流进展发生率低于手术组（0.6%比 6.1%）（相对风险，0.09；95%CI，0.01 至 0.69）。两组患者 2 年时主要不良心脏和脑血管事件、功能状态和生活质量的发生率相似，但手术加 TA 组永久性心脏起搏器植入的发生率高于手术组（14.1%比 2.5%）（率比，5.75；95%CI，2.27 至 14.60）。
结论
在接受二尖瓣手术的患者中，与单独接受二尖瓣手术的患者相比，同时接受 TA 的患者在 2 年内主要终点事件的发生率较低，这主要是由于严重三尖瓣反流的进展频率降低。三尖瓣修复导致更频繁的永久性心脏起搏器植入。只有通过更长时间的随访，才能确定三尖瓣反流进展减少是否会带来长期的临床获益。（由美国国立心肺血液研究所和德国心血管研究中心资助；ClinicalTrials.gov 编号，NCT02675244。）
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