Department of Medicine, Division of Cardiology/New York Presbyterian Hospital, New York-Presbyterian/Columbia University Medical Center, New York, New York; Cardiovascular Research Foundation, New York, New York.
Marcus Heart Valve Center, Piedmont Heart Institute, Atlanta, Georgia.
J Am Coll Cardiol. 2017 Apr 11;69(14):1795-1806. doi: 10.1016/j.jacc.2017.01.054.
The SCOUT (Percutaneous Tricuspid Valve Annuloplasty System for Symptomatic Chronic Functional Tricuspid Regurgitation) trial is a prospective, single-arm, multicenter, early feasibility study of a novel transcatheter device to plicate the tricuspid annulus (TA) and reduce tricuspid regurgitation (TR).
This study tested the feasibility and safety of a novel transcatheter device and assessed its early performance and functional outcomes.
Between November 2015 and June 2016, 15 patients with New York Heart Association (NYHA) functional class ≥II and moderate or greater functional TR were enrolled. Primary performance and safety endpoint outcomes were technically successful at 30 days with no reintervention. Echocardiographic measurements (TA diameter, effective regurgitant orifice area [EROA], left ventricular stroke volume [LVSV]) and quality-of-life (QoL) measurements (NYHA functional class, Minnesota Living with Heart Failure Questionnaire [MLHFQ], and 6-min walk test [6MWT]) were performed at baseline and 30 days.
All patients (mean 73.2 ± 6.9 years of age, 87% female) underwent successful device implantation with no deaths, strokes, bleeding, tamponade, or valve reintervention. Technical success rate at 30 days was 80%, with 3 single-pledget annular detachments without reintervention. In the remaining 12 patients, there were significant reductions in TA (12.3 ± 3.1 cm to 11.3 ± 2.7 cm, respectively; p = 0.019) and EROA (0.51 ± 0.18 cm vs. 0.32 ± 0.18 cm, respectively; p = 0.020), with significant increase in LVSV (63.6 ± 17.9 ml vs. 71.5 ± 25.7 ml, respectively; p = 0.021). In the intention-to-treat cohort, there were significant improvements in NYHA functional class (≥1 class, p = 0.001), MLHFQ (47.4 ± 17.6 to 20.9 ± 14.8; p < 0.001), and 6MWT (245.2 ± 110.1 to 298.0 m ± 107.6 m; p = 0.008).
The 30-day results of the SCOUT trial confirmed the safety of the novel transcatheter device, which reduced TA and EROA, increased LVSV, and improved QoL. (Early Feasibility of the Mitralign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS) Also Known as TriAlign [SCOUT]; NCT02574650.).
SCOUT（经皮三尖瓣瓣环成形术系统治疗有症状的慢性功能性三尖瓣反流）试验是一项前瞻性、单臂、多中心的早期可行性研究，旨在评估一种新型经导管装置对三尖瓣瓣环（TA）进行折叠并减少三尖瓣反流（TR）的效果。
本研究旨在测试一种新型经导管装置的可行性和安全性，并评估其早期性能和功能结果。
2015 年 11 月至 2016 年 6 月，共纳入 15 名纽约心脏协会（NYHA）心功能分级≥II 级且存在中度或重度功能性 TR 的患者。主要的性能和安全性终点是在 30 天内无再次介入的技术成功。在基线和 30 天时进行超声心动图测量（TA 直径、有效反流口面积[EROA]、左心室每搏量[LVSV]）和生活质量（QoL）测量（NYHA 心功能分级、明尼苏达心力衰竭生活质量问卷[MLHFQ]和 6 分钟步行试验[6MWT]）。
所有患者（平均年龄 73.2 ± 6.9 岁，87%为女性）均成功植入装置，无死亡、卒中等并发症发生，也未发生出血、心脏压塞或需要再次介入治疗的情况。30 天时的技术成功率为 80%，有 3 例单个瓣环瓣叶脱附，但无需再次介入治疗。在其余 12 名患者中，TA（12.3 ± 3.1 cm 至 11.3 ± 2.7 cm，p=0.019）和 EROA（0.51 ± 0.18 cm 至 0.32 ± 0.18 cm，p=0.020）显著减小，LVSV（63.6 ± 17.9 ml 至 71.5 ± 25.7 ml，p=0.021）显著增加。意向治疗队列中，NYHA 心功能分级（至少改善 1 级，p=0.001）、MLHFQ（47.4 ± 17.6 至 20.9 ± 14.8；p<0.001）和 6MWT（245.2 ± 110.1 至 298.0 m ± 107.6 m；p=0.008）均显著改善。
SCOUT 试验 30 天的结果证实了新型经导管装置的安全性，该装置可减小 TA 和 EROA，增加 LVSV，并改善 QoL。[Mitralign 经皮三尖瓣瓣环成形术系统（PTVAS）也称为 TriAlign（SCOUT）的早期可行性研究；NCT02574650]。
