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肺动脉高压与经导管二尖瓣修复术临床结局的相关性。

Association of Pulmonary Hypertension With Clinical Outcomes of Transcatheter Mitral Valve Repair.

机构信息

Cardiology Division, Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston.

Duke Clinical Research Institute, Duke University Medical Center, Durham, North Carolina.

出版信息

JAMA Cardiol. 2020 Jan 1;5(1):47-56. doi: 10.1001/jamacardio.2019.4428.

Abstract

IMPORTANCE

Pulmonary hypertension (pHTN) is associated with increased risk of mortality after mitral valve surgery for mitral regurgitation. However, its association with clinical outcomes in patients undergoing transcatheter mitral valve repair (TMVr) with a commercially available system (MitraClip) is unknown.

OBJECTIVE

To assess the association of pHTN with readmissions for heart failure and 1-year all-cause mortality after TMVr.

DESIGN, SETTING, AND PARTICIPANTS: This retrospective cohort study analyzed 4071 patients who underwent TMVr with the MitraClip system from November 4, 2013, through March 31, 2017, across 232 US sites in the Society of Thoracic Surgery/American College of Cardiology Transcatheter Valve Therapy registry. Patients were stratified into the following 4 groups based on invasive mean pulmonary arterial pressure (mPAP): 1103 with no pHTN (mPAP, <25 mm Hg [group 1]); 1399 with mild pHTN (mPAP, 25-34 mm Hg [group 2]); 1011 with moderate pHTN (mPAP, 35-44 mm Hg [group 3]); and 558 with severe pHTN (mPAP, ≥45 mm Hg [group 4]). Data were analyzed from November 4, 2013, through March 31, 2017.

INTERVENTIONS

Patients were stratified into groups before TMVr, and clinical outcomes were assessed at 1 year after intervention.

MAIN OUTCOMES AND MEASURES

Primary end point was a composite of 1-year mortality and readmissions for heart failure. Secondary end points were 30-day and 1-year mortality and readmissions for heart failure. Linkage to Centers for Medicare & Medicaid Services administrative claims was performed to assess 1-year outcomes in 2381 patients.

RESULTS

Among the 4071 patients included in the analysis, the median age was 81 years (interquartile range, 73-86 years); 1885 (46.3%) were women and 2186 (53.7%) were men. The composite rate of 1-year mortality and readmissions for heart failure was 33.6% (95% CI, 31.6%-35.7%), which was higher in those with pHTN (27.8% [95% CI, 24.2%-31.5%] in group 1, 32.4% [95% CI, 29.0%-35.8%] in group 2, 36.0% [95% CI, 31.8%-40.2%] in group 3, and 45.2% [95% CI, 39.1%-51.0%] in group 4; P < .001). Similarly, 1-year mortality (16.3% [95% CI, 13.4%-19.5%] in group 1, 19.8% [95% CI, 17.0%-22.8%] in group 2, 22.4% [95% CI, 18.8%-26.1%] in group 3, and 27.8% [95% CI, 22.6%-33.3%] in group 4; P < .001) increased across pHTN groups. The association of pHTN with mortality persisted despite multivariable adjustment (hazard ratio per 5-mm Hg mPAP increase, 1.05; 95% CI, 1.01-1.09; P = .02).

CONCLUSIONS AND RELEVANCE

These findings suggest that pHTN is associated with increased mortality and readmission for heart failure in patients undergoing TMVr using the MitraClip system for severe mitral regurgitation. Further efforts are needed to determine whether earlier intervention before pHTN develops will improve clinical outcomes.

摘要

重要性

肺动脉高压(pHTN)与二尖瓣反流患者行二尖瓣修复手术后的死亡率增加相关。然而,其与使用商业上可用的系统(MitraClip)行经导管二尖瓣修复术(TMVr)的患者的临床结局之间的关联尚不清楚。

目的

评估 pHTN 与 TMVr 后心力衰竭再入院和 1 年全因死亡率之间的关系。

设计、地点和参与者:这项回顾性队列研究分析了 2013 年 11 月 4 日至 2017 年 3 月 31 日期间在美国 232 个地点接受 MitraClip 系统 TMVr 的 4071 名患者。根据有创平均肺动脉压(mPAP),患者被分为以下 4 组:1103 名无 pHTN(mPAP,<25mmHg[组 1]);1399 名轻度 pHTN(mPAP,25-34mmHg[组 2]);1011 名中度 pHTN(mPAP,35-44mmHg[组 3]);和 558 名重度 pHTN(mPAP,≥45mmHg[组 4])。数据于 2013 年 11 月 4 日至 2017 年 3 月 31 日进行分析。

干预措施

患者在 TMVr 前被分为不同组,在干预后 1 年评估临床结局。

主要结局和测量指标

主要终点是 1 年死亡率和心力衰竭再入院的复合终点。次要结局是 30 天和 1 年死亡率和心力衰竭再入院。与医疗保险和医疗补助服务中心行政索赔进行关联,以评估 2381 名患者的 1 年结局。

结果

在纳入分析的 4071 名患者中,中位年龄为 81 岁(四分位距,73-86 岁);1885 名(46.3%)为女性,2186 名(53.7%)为男性。1 年死亡率和心力衰竭再入院的复合发生率为 33.6%(95%CI,31.6%-35.7%),pHTN 患者的发生率更高(组 1 为 27.8%[95%CI,24.2%-31.5%],组 2 为 32.4%[95%CI,29.0%-35.8%],组 3 为 36.0%[95%CI,31.8%-40.2%],组 4 为 45.2%[95%CI,39.1%-51.0%];P<0.001)。同样,1 年死亡率(组 1 为 16.3%[95%CI,13.4%-19.5%],组 2 为 19.8%[95%CI,17.0%-22.8%],组 3 为 22.4%[95%CI,18.8%-26.1%],组 4 为 27.8%[95%CI,22.6%-33.3%];P<0.001)也随着 pHTN 组的增加而增加。即使进行多变量调整,pHTN 与死亡率的关联仍然存在(每增加 5mmHg mPAP,风险比为 1.05;95%CI,1.01-1.09;P=0.02)。

结论和相关性

这些发现表明,在使用 MitraClip 系统治疗严重二尖瓣反流的患者中,pHTN 与 TMVr 后死亡率和心力衰竭再入院增加相关。需要进一步努力确定在 pHTN 发生之前进行早期干预是否会改善临床结局。

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