Departments of Cardiology and Cardiothoracic Surgery, St. Vincent's Hospital, Sydney, Australia.
Center for Valve and Structural Heart Disease and Cardiothoracic Surgery Service, Minneapolis Heart Institute at Abbott Northwestern Hospital, Minneapolis, Minnesota.
J Am Coll Cardiol. 2017 Jan 31;69(4):381-391. doi: 10.1016/j.jacc.2016.10.068. Epub 2016 Dec 28.
Symptomatic mitral regurgitation (MR) is associated with high morbidity and mortality that can be ameliorated by surgical valve repair or replacement. Despite this, many patients with MR do not undergo surgery. Transcatheter mitral valve replacement (TMVR) may be an option for selected patients with severe MR.
This study aimed to examine the effectiveness and safety of TMVR in a cohort of patients with native valve MR who were at high risk for cardiac surgery.
Patients underwent transcatheter, transapical delivery of a self-expanding mitral valve prosthesis and were examined in a prospective registry for short-term and 30-day outcomes.
Thirty patients (age 75.6 ± 9.2 years; 25 men) with grade 3 or 4 MR underwent TMVR. The MR etiology was secondary (n = 23), primary (n = 3), or mixed pathology (n = 4). The Society of Thoracic Surgeons Predicted Risk of Mortality was 7.3 ± 5.7%. Successful device implantation was achieved in 28 patients (93.3%). There were no acute deaths, strokes, or myocardial infarctions. One patient died 13 days after TMVR from hospital-acquired pneumonia. Prosthetic leaflet thrombosis was detected in 1 patient at follow-up and resolved after increased oral anticoagulation with warfarin. At 30 days, transthoracic echocardiography showed mild (1+) central MR in 1 patient, and no residual MR in the remaining 26 patients with valves in situ. The left ventricular end-diastolic volume index decreased (90.1 ± 28.2 ml/m at baseline vs. 72.1 ± 19.3 ml/m at follow-up; p = 0.0012), as did the left ventricular end-systolic volume index (48.4 ± 19.7 ml/m vs. 43.1 ± 16.2 ml/m; p = 0.18). Seventy-five percent of the patients reported mild or no symptoms at follow-up (New York Heart Association functional class I or II). Successful device implantation free of cardiovascular mortality, stroke, and device malfunction at 30 days was 86.6%.
TMVR is an effective and safe therapy for selected patients with symptomatic native MR. Further evaluation of TMVR using prostheses specifically designed for the mitral valve is warranted. This intervention may help address an unmet need in patients at high risk for surgery. (Early Feasibility Study of the Tendyne Mitral Valve System [Global Feasibility Study]; NCT02321514).
有症状的二尖瓣反流（MR）与高发病率和死亡率相关，手术瓣膜修复或置换可改善这些情况。尽管如此，仍有许多患有 MR 的患者未接受手术。经导管二尖瓣置换术（TMVR）可能是一种选择，用于治疗有严重 MR 的特定患者。
本研究旨在检查经导管、经心尖输送自扩张二尖瓣假体在一群高危心脏手术的原发性二尖瓣 MR 患者中的有效性和安全性。
患者接受经导管、经心尖输送的自扩张二尖瓣假体，并在前瞻性登记处接受短期和 30 天结果检查。
30 名（年龄 75.6 ± 9.2 岁；25 名男性）有 3 级或 4 级 MR 的患者接受了 TMVR。MR 的病因是继发性（n = 23）、原发性（n = 3）或混合性病变（n = 4）。胸外科医生协会预测死亡率为 7.3 ± 5.7%。28 名患者（93.3%）成功植入了设备。无急性死亡、中风或心肌梗死。1 名患者在 TMVR 后 13 天因医院获得性肺炎死亡。1 名患者在随访中发现人工瓣叶血栓形成，经增加华法林口服抗凝治疗后得到解决。30 天时，经胸超声心动图显示 1 名患者存在轻度（1+）中心性 MR，其余 26 名患者的原位瓣膜无残留 MR。左心室舒张末期容积指数降低（基线时 90.1 ± 28.2 ml/m，随访时 72.1 ± 19.3 ml/m；p = 0.0012），左心室收缩末期容积指数也降低（48.4 ± 19.7 ml/m vs. 43.1 ± 16.2 ml/m；p = 0.18）。75%的患者在随访时报告有轻度或无症状（纽约心脏协会功能分级 I 或 II）。30 天无心血管死亡、中风和器械故障的成功器械植入率为 86.6%。
TMVR 是一种治疗有症状的原发性 MR 的有效且安全的治疗方法。需要进一步使用专门为二尖瓣设计的假体评估 TMVR。这种干预措施可能有助于满足高危手术患者的未满足需求。（Tendyne 二尖瓣系统的早期可行性研究[全球可行性研究]；NCT02321514）。
