新型经导管边缘到边缘修复系统的早期美国商业经验

IF 11.4 1区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS

JACC. Cardiovascular interventions Pub Date : 2025-08-25 DOI:10.1016/j.jcin.2025.07.019

Thomas Waggoner DO , Santiago Garcia MD , Tarun Chakravarty MD , Moody Makar MD , Azeem Latib MD , Robert M. Kipperman MD , Firas Zahr MD , Ivan Hanson MD , Anjan K. Sinha MD , Rahul P. Sharma MD , Jeremiah P. Depta MD , Jorge A. Castellanos MD , Susheel Kodali MD , Amar Krishnaswamy MD , Brian Whisenant MD , Daniel Menees MD , D. Scott Lim MD , Fahad Gilani MD , Carlos E. Sanchez MD , Neil Gheewala MD , Raj Makkar MD

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引用次数: 0

摘要

PASCAL精密经导管瓣膜修复系统为治疗具有明显症状性退行性二尖瓣反流（DMR）的手术风险患者提供了一种新的选择。目的报告美国PASCAL精密系统的早期商业经验。方法从STS/ACC TVT注册表中对美国PASCAL精密系统治疗的DMR患者进行分析。评估30天的手术、临床、超声心动图、功能和生活质量结果。所有结果，包括超声心动图评估，都是现场评估的。结果1995例DMR患者中位年龄为81.6岁，男性占57.0%。二尖瓣修复的STS-PROM中位数为3.6%，NYHA功能III/IV级为69.4%。混合病因（DMR +其他病因）占11.4%，66.9%解剖复杂（二尖瓣环/小叶钙化，二尖瓣面积约4cm2，二尖瓣连枷/脱垂/栓系或二尖瓣狭窄）。植入成功率97.7%。30天MR降低显著，94.2%达到中度MR， 72.6%达到轻度MR（与基线相比P <； 0.001）。患者经历了显著的功能和生活质量改善，堪萨斯城心肌病问卷评分平均提高21.0分，NYHA功能分级平均提高84.6%（均P <； 0.001）。二尖瓣再介入和单叶装置附着率分别为0.4%和0.5%，30天全因死亡率、心血管死亡率和心力衰竭再入院率分别为2.2%、1.2%和2.6%。结论：美国STS/ACC TVT注册中心的早期商业经验证实了新型PASCAL Precision系统在治疗大量现实世界DMR患者中的安全性和有效性。

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Early U.S. Commercial Experience With a Novel Transcatheter Edge-to-Edge Repair System

Background

The PASCAL Precision transcatheter valve repair system provides a new option for treating prohibitive surgical risk patients with significant, symptomatic degenerative mitral regurgitation (DMR).

Objectives

The authors report early U.S. commercial experience with the PASCAL Precision system.

Methods

Patients with DMR treated with the PASCAL Precision system in the United States were analyzed from the STS/ACC TVT Registry. Procedural, clinical, echocardiographic, functional, and quality-of-life outcomes to 30 days were assessed. All outcomes, including echocardiographic assessments, were site-assessed.

Results

In 1,995 DMR patients, the median age was 81.6 years, and 57.0% were male. Median STS-PROM for mitral valve repair was 3.6%, and 69.4% were in NYHA functional class III/IV. Mixed etiology (DMR + other etiology) was present in 11.4%, and 66.9% had complex anatomy (annular/leaflet calcification, mitral valve area <4 cm², bileaflet flail/prolapse/tethering, or mitral stenosis). The device was successfully implanted in 97.7%. MR reduction was significant at 30 days with 94.2% achieving ≤moderate MR and 72.6% ≤mild MR (P < 0.001 vs baseline). Patients experienced significant functional and quality-of-life improvements with a mean 21.0-point increase in Kansas City Cardiomyopathy Questionnaire score and 84.6% in NYHA functional class I/II (all P < 0.001). Mitral valve reintervention and single-leaflet device attachment rates were 0.4% and 0.5%, respectively, and all-cause mortality, cardiovascular mortality, and heart failure readmission rates were 2.2%, 1.2%, and 2.6%, respectively, at 30 days.

Conclusions

Early U.S. STS/ACC TVT Registry commercial experience confirms the safety and effectiveness of the novel PASCAL Precision system in the treatment of a broad population of real-world DMR patients.

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来源期刊

JACC. Cardiovascular interventions CARDIAC & CARDIOVASCULAR SYSTEMS-

CiteScore

11.60

自引率

8.80%

发文量

756

审稿时长

4-8 weeks

期刊介绍： JACC: Cardiovascular Interventions is a specialist journal launched by the Journal of the American College of Cardiology (JACC). It covers the entire field of interventional cardiovascular medicine, including cardiac, peripheral, and cerebrovascular interventions. The journal publishes studies that will impact the practice of interventional cardiovascular medicine, including clinical trials, experimental studies, and in-depth discussions by respected experts. To enhance visual understanding, the journal is published both in print and electronically, utilizing the latest technologies.