Valve Science Center, Minneapolis Heart Institute Foundation at Abbott Northwestern Hospital, Minneapolis, Minnesota.
Royal Brompton Hospital, London, United Kingdom.
J Am Coll Cardiol. 2019 Mar 26;73(11):1250-1260. doi: 10.1016/j.jacc.2018.12.066.
Transcatheter mitral valve replacement (TMVR) is a rapidly evolving therapy. Follow-up of TMVR patients remains limited in duration and number treated.
The purpose of this study was to examine outcomes with expanded follow-up for the first 100 patients who underwent TMVR with the prosthesis.
The Global Feasibility Study enrolled symptomatic patients with either primary or secondary mitral regurgitation (MR) who were at high or prohibitive surgical risk. The present investigation examines the first 100 patients treated in this study. Clinical outcomes through last clinical follow-up were adjudicated independently.
In the cohort (mean age 75.4 ± 8.1 years; 69% men), there was a high prevalence of severe heart failure symptoms (66%), left ventricular dysfunction (mean ejection fraction 46.4 ± 9.6%), and morbidities (Society of Thoracic Surgeons Predicted Risk of Mortality, 7.8 ± 5.7%). There were no intraprocedural deaths, 1 instance of major apical bleeding, and no acute conversion to surgery or need for cardiopulmonary bypass. Technical success was 96%. The 30-day rates of mortality and stroke were 6% and 2%, respectively. The 1-year survival free of all-cause mortality was 72.4% (95% confidence interval: 62.1% to 80.4%), with 84.6% of deaths due to cardiac causes. Among survivors at 1 year, 88.5% were New York Heart Association function class I/II, and improvements in 6-min walk distance (p < 0.0001) and quality-of-life measurements occurred (p = 0.011). In 73.4% of survivors, the Kansas City Cardiomyopathy Questionnaire score improved by ≥10 points.
In this study of TMVR, which is the largest experience to date, the prosthesis was highly effective in relieving MR and improving symptoms, with an acceptable safety profile. Further study to optimize the impact on long-term survival is needed.
经导管二尖瓣置换术（TMVR）是一种快速发展的治疗方法。TMVR 患者的随访时间和治疗数量仍然有限。
本研究的目的是检查首例 100 例接受 TMVR 治疗的患者在扩大随访后的结果。
全球可行性研究纳入了症状性患者，这些患者患有原发性或继发性二尖瓣反流（MR），且具有高或极高的手术风险。本研究调查了该研究中治疗的前 100 例患者。通过最后一次临床随访独立判断临床结局。
在该队列（平均年龄 75.4 ± 8.1 岁；69%为男性）中，严重心力衰竭症状（66%）、左心室功能障碍（平均射血分数 46.4 ± 9.6%）和合并症（胸外科医师协会预测死亡率，7.8 ± 5.7%）的患病率较高。无术中死亡、1 例心尖大出血、无急性转为手术或需要体外循环。技术成功率为 96%。30 天死亡率和卒中发生率分别为 6%和 2%。1 年全因死亡率为 72.4%（95%置信区间：62.1%至 80.4%），84.6%的死亡为心源性。在 1 年时的存活者中，88.5%为纽约心脏协会功能 I/II 级，6 分钟步行距离（p<0.0001）和生活质量测量得到改善（p=0.011）。在 73.4%的存活者中，堪萨斯城心肌病问卷评分提高了≥10 分。
在这项迄今为止最大规模的 TMVR 研究中，该假体在缓解 MR 和改善症状方面非常有效，具有可接受的安全性。需要进一步研究以优化对长期生存的影响。
