美国早期使用新型经导管边缘对边缘修复系统的商业经验：来自真实世界数据的见解

Early U.S. Commercial Experience With a Novel Transcatheter Edge-to-Edge Repair System: Insights From Real-World Data.

作者信息

Waggoner Thomas, Garcia Santiago, Chakravarty Tarun, Makar Moody, Latib Azeem, Kipperman Robert M, Zahr Firas, Hanson Ivan, Sinha Anjan K, Sharma Rahul P, Depta Jeremiah P, Castellanos Jorge A, Kodali Susheel, Krishnaswamy Amar, Whisenant Brian, Menees Daniel, Lim D Scott, Gilani Fahad, Sanchez Carlos E, Gheewala Neil, Gada Hemal, Kapadia Samir, Ramanathan P Kasi, Shah Pinak B, Renard Brian, Theodos Gus, Yaryura Ricardo, Gardner Blake, Steinberg Daniel H, Gnall Eric, Kaddissi Georges, Chhatriwalla Adnan K, Frangieh Antonio H, Eleid Mackram F, Géneréux Philippe, Saxon John T, Villablanca Pedro, Matar Fadi, Agarwal Himanshu, Chetcuti Stanley, Frisoli Tiberio, Makkar Raj

机构信息

US Heart & Vascular Tucson Medical Center, Tucson, Arizona, USA.

The Christ Hospital, Cincinnati, Ohio, USA.

出版信息

JACC Cardiovasc Interv. 2025 Aug 25;18(16):2036-2046. doi: 10.1016/j.jcin.2025.07.019.

DOI:10.1016/j.jcin.2025.07.019

PMID:40866033

Abstract

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 cm, 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.

摘要

背景

PASCAL Precision经导管瓣膜修复系统为治疗具有高手术风险的有症状的严重退行性二尖瓣反流（DMR）患者提供了一种新选择。

目的

作者报告PASCAL Precision系统在美国的早期商业应用经验。

方法

从STS/ACC TVT注册中心分析在美国接受PASCAL Precision系统治疗的DMR患者。评估至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，均由各中心评估。

结果

1995例DMR患者中，中位年龄为81.6岁，57.0%为男性。二尖瓣修复的中位STS-PROM为3.6%，69.4%为纽约心脏协会（NYHA）功能分级III/IV级。11.4%存在混合病因（DMR+其他病因），66.9%有复杂解剖结构（瓣环/瓣叶钙化、二尖瓣面积<4 cm、双叶瓣脱垂/连枷/受限或二尖瓣狭窄）。该装置成功植入率为97.7%。30天时二尖瓣反流减少显著，94.2%的患者二尖瓣反流≤中度，72.6%≤轻度（与基线相比，P<0.001）。患者的功能和生活质量有显著改善，堪萨斯城心肌病问卷评分平均提高21.0分，84.6%的患者为NYHA功能分级I/II级（所有P<0.001）。二尖瓣再次干预率和单叶瓣装置附着率分别为0.4%和0.5%，30天时全因死亡率、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%。