Background

Transcatheter treatment techniques for tricuspid regurgitation (TR) have evolved in recent years, with leaflet repair being the most commonly used, but thus far evidence on the PASCAL and PASCAL Ace system is based mainly on compassionate use data.

Objectives

This is the first report on commercial use in a multicenter study with a large patient cohort investigating the safety and efficacy of the PASCAL and PASCAL Ace system in the treatment of TR.

Methods

In a retrospective, multicenter, observational setting, data from all consecutive patients undergoing leaflet repair for TR at 8 centers was collected, including a centralized analysis of echocardiographic data.

Results

A total of 235 high-risk patients (mean age 78 ± 8 years, 49% women, mean Society of Thoracic Surgeons Predicted Risk of Mortality score 8.6% ± 6.8%) were included. TR was functional in 87% of patients and graded severe or higher in 91%. TR was successfully reduced to moderate or less in 78% of patients (P < 0.001). Procedural success was 78% (n = 153). At the latest available follow-up (median 173 days), TR reduction was sustained (78% with TR moderate or less; P < 0.001), and echocardiography showed indications of right ventricular remodeling (mean right ventricular end-diastolic diameter 56 ± 9 mm vs 53 ± 9 mm; P < 0.001). Patients’ symptoms diminished significantly (63% were in New York Heart Association functional class I or II at follow-up; P < 0.001). In a device-specific analysis, the PASCAL and PASCAL Ace showed no difference in TR reduction (postprocedural TR moderate or less in 77% vs 78%; P = 0.82).

Conclusions

In early clinical experience, the PASCAL (Ace) leaflet repair system has high technical and procedural success rates with efficient TR reduction and significant clinical and echocardiographic improvement at follow-up.

中文翻译：

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有症状三尖瓣反流的经导管小叶修复系统的多中心经验

背景

近年来，三尖瓣反流 (TR) 的经导管治疗技术不断发展，其中小叶修复是最常用的，但迄今为止关于 PASCAL 和 PASCAL Ace 系统的证据主要基于同情使用数据。

目标

这是第一份关于商业用途的多中心研究报告，该研究有一个大型患者队列，调查 PASCAL 和 PASCAL Ace 系统在治疗 TR 中的安全性和有效性。

方法

在一项回顾性、多中心、观察性设置中，收集了 8 个中心接受 TR 小叶修复的所有连续患者的数据，包括对超声心动图数据的集中分析。

结果

共纳入 235 名高危患者（平均年龄 78 ± 8 岁，49% 为女性，胸外科医师协会平均预测死亡风险评分为 8.6% ± 6.8%）。TR 在 87% 的患者中功能正常，在 91% 的患者中分级为严重或更高。78% 的患者 TR 成功降至中度或以下（P  < 0.001）。手术成功率为 78% (n = 153)。在最近的可用随访中（中位 173 天），TR 持续降低（78% 的 TR 中等或更低；P  < 0.001），超声心动图显示右心室重构的迹象（平均右心室舒张末期直径 56 ± 9毫米与 53 ± 9 毫米；P  < 0.001）。患者的症状显着减轻（63% 在随访时处于纽约心脏协会功能分级 I 或 II 级；P  < 0.001)。在一项特定于设备的分析中，PASCAL 和 PASCAL Ace 在 TR 降低方面没有差异（77% 对 78% 的术后 TR 中等或更少；P  = 0.82）。

结论

在早期临床经验中，PASCAL (Ace) 瓣叶修复系统具有很高的技术和程序成功率，可有效减少 TR，并在随访中显着改善临床和超声心动图。