JACC. Cardiovascular interventions最新文献

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Multicenter Pivotal Study of the Alterra Adaptive Prestent for the Treatment of Pulmonary Regurgitation 治疗肺动脉反流的 Alterra Adaptive Prestent 多中心关键性研究

IF 11.7 1区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS

JACC. Cardiovascular interventions

Pub Date : 2024-10-14 DOI: 10.1016/j.jcin.2024.07.036

Background

A dilated native right ventricular outflow tract (RVOT) presents unique challenges for transcatheter management using balloon-expandable valves. The Alterra Adaptive Prestent was designed to expand transcatheter therapy to treat patients with dilated RVOTs.

Objectives

The aim of this study was to report 2-year outcomes of the main cohort of the ALTERRA (Multicenter Study of Congenital Pulmonic Valve Dysfunction Studying the SAPIEN 3 THV With the Alterra Adaptive Prestent) pivotal trial using the prestent with transcatheter pulmonary valve replacement.

Methods

The prestent device used with the 29 mm SAPIEN 3 transcatheter heart valve (THV) was evaluated for the management of patients with moderate or greater pulmonary valve regurgitation (PR). The primary endpoint was THV dysfunction at 6 months, defined as a nonhierarchical composite of RVOT/pulmonary valve reintervention, moderate or greater total PR on transthoracic echocardiography, and mean RVOT/pulmonary valve gradient 35 mm Hg or greater on transthoracic echocardiography. The primary endpoint and outcomes through 2 years are presented in this analysis.

Results

Of 97 patients screened, 60 underwent prestent and THV implantation. There was 1 staged procedure. No patients had THV dysfunction at 6 months. At 2 years, the majority of patients (92.5%) had mild or less PR, with no reports of coronary compression, stent fractures warranting reintervention, or endocarditis. Of the 21 patients (34.4%) who experienced early (days 0-1) arrhythmias, 12 had episodes of nonsustained ventricular tachycardia that resolved with medication. One patient underwent reintervention secondary to an iatrogenic RVOT obstruction; there were no deaths or explantations through 2 years.

Conclusions

The Alterra prestent in combination with the SAPIEN 3 THV has excellent outcomes at 2 years, with no significant valve dysfunction in the main pivotal cohort.

背景扩张的原发性右心室流出道（RVOT）给使用球囊扩张瓣膜进行经导管治疗带来了独特的挑战。本研究旨在报告 ALTERRA（使用 Alterra Adaptive Prestent 的先天性肺动脉瓣功能障碍多中心研究 SAPIEN 3 THV）关键性试验中使用 Prestent 和经导管肺动脉瓣置换术的主要队列的 2 年结果。方法评估了与 29 毫米 SAPIEN 3 经导管心脏瓣膜（THV）一起使用的 Prestent 装置对中度或更严重肺动脉瓣反流（PR）患者的治疗效果。主要终点是6个月时的THV功能障碍，定义为RVOT/肺动脉瓣再介入、经胸超声心动图显示中度或更严重的总PR、经胸超声心动图显示平均RVOT/肺动脉瓣梯度为35 mm Hg或更大的非等级复合。本分析报告显示了主要终点和 2 年后的结果。结果在 97 名接受筛查的患者中，60 人接受了预支架和 THV 植入术。其中有 1 例分期手术。6 个月时，没有患者出现 THV 功能障碍。2 年后，大多数患者（92.5%）的 PR 为轻度或轻度以下，无冠状动脉压迫、需要重新介入的支架断裂或心内膜炎的报告。在 21 名出现早期（0-1 天）心律失常的患者（34.4%）中，12 人出现非持续性室性心动过速，药物治疗后缓解。结论Alterra prestent与SAPIEN 3 THV联合使用2年后疗效极佳，主要关键队列中没有出现明显的瓣膜功能障碍。

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引用次数: 0

Another Frontier to Conquer in Coronary Chronic Total Occlusion 征服冠状动脉慢性全闭塞的另一个前沿领域

IF 11.7 1区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS

JACC. Cardiovascular interventions

Pub Date : 2024-10-14 DOI: 10.1016/j.jcin.2024.08.024

引用次数: 0

Long-Term Results of the Atrial Septal Defect Occluder ASSURED Trial for Combined Pivotal/Continued Access Cohorts 心房间隔缺损封堵器 ASSURED 试验中枢组/持续通路组的长期结果。

IF 11.7 1区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS

JACC. Cardiovascular interventions

Pub Date : 2024-10-14 DOI: 10.1016/j.jcin.2024.07.013

Background

The GORE CARDIOFORM ASD Occluder (GCA, W. L. Gore & Associates) was approved in 2019 for ostium secundum atrial septal defect (ASD) closure.

Objectives

This study sought to report the combined pivotal and continued access cohorts of the ASSURED (Safety and Efficacy Study of Transcatheter Closure of Ostium Secundum ASDs) trial results through 36 months.

Methods

This prospective, multicenter, single-arm trial evaluated procedural and clinical outcomes of ASD closure with the GCA. The primary endpoints were 6-month closure success following device implantation and composite clinical success (deployment/retention of device, safety, and closure). Technical and procedure success, safety, clinically significant new arrhythmia (CSNA) secondary endpoints, and wire frame fracture (WFF, with fluoroscopy) at 6 and 36 months were evaluated.

Results

Of 569 patients (median age of 10.4 years and median weight of 35.0 kg) who underwent attempted secundum ASD closure, 526 were technical successes. The mean stop-flow ASD diameter was 17.6 ± 5.3 mm. All 478 patients with 6-month imaging achieved closure success. Composite clinical success at 6 and 36 months was achieved in 87.6% (468/534) and 84.0% (351/418) of patients, respectively. Technical failure occurred in 8.1% (43/548), 30-day device- or procedure-related serious adverse event in 3.9% (21/534), and 6-month device events in 2.8% (15/534) of patients. At 30 days, 21 of 569 patients (3.7%) had CSNA. At 6 months, 138 of 436 (31.7%) patients had WFFs and 105 of 185 (56.8%) at 36 months (without sequelae).

Conclusions

In this large congenital ASD device trial, the GCA had acceptable results. WFFs, although common, did not result in any clinical sequelae. The unique features, size range, and safety profile expand the options for secundum ASD closure. (Safety and Efficacy Study of Transcatheter Closure of Ostium Secundum ASDs [ASSURED]; NCT02985684)

背景：GORE CARDIOFORM ASD Occluder（GCA，W. L. Gore & Associates）于2019年获批用于房间隔缺损（ASD）闭合：本研究旨在报告 ASSURED（经导管封堵房间隔缺损的安全性和有效性研究）试验的关键组和持续进入组的综合结果，直至 36 个月：这项前瞻性、多中心、单臂试验评估了使用 GCA 封闭 ASD 的程序和临床结果。主要终点是设备植入后 6 个月的闭合成功率和综合临床成功率（设备的部署/保留、安全性和闭合）。在 6 个月和 36 个月时对技术和手术成功率、安全性、临床显著新心律失常（CSNA）次要终点以及线框断裂（WFF，透视）进行评估：在 569 名尝试进行二次 ASD 闭合的患者（中位年龄 10.4 岁，中位体重 35.0 千克）中，有 526 人技术成功。ASD的平均止血直径为17.6 ± 5.3 mm。所有 478 名接受 6 个月影像学检查的患者都获得了闭合成功。6个月和36个月的综合临床成功率分别为87.6%（468/534）和84.0%（351/418）。8.1%（43/548）的患者发生了技术故障，3.9%（21/534）的患者发生了 30 天的设备或手术相关严重不良事件，2.8%（15/534）的患者发生了 6 个月的设备事件。30 天时，569 位患者中有 21 位（3.7%）出现 CSNA。6个月时，436名患者中有138名（31.7%）发生了WFF，36个月时，185名患者中有105名（56.8%）发生了WFF（无后遗症）：结论：在这项大型先天性 ASD 装置试验中，GCA 取得了可接受的结果。WFFs 虽然常见，但并未导致任何临床后遗症。其独特的功能、尺寸范围和安全性扩大了后天性 ASD 闭合的选择范围。(经导管闭合峡部ASD的安全性和有效性研究 [ASSURED]；NCT02985684）。

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