JACC. Cardiovascular interventions最新文献

英文中文

Pioneering Treatment for Aortic Regurgitation 主动脉反流的开创性治疗

IF 11.4 1区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS

JACC. Cardiovascular interventions

Pub Date : 2025-12-22 DOI: 10.1016/j.jcin.2025.10.032

Kush P. Patel PhD , Andreas Baumbach MD

引用次数: 0

Effect of Postdilatation at Nominal Volume on THV Stent Frame Deformation and Eccentricity 名义体积后扩张对THV支架框架变形和偏心的影响

IF 11.4 1区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS

JACC. Cardiovascular interventions

Pub Date : 2025-12-22 DOI: 10.1016/j.jcin.2025.09.050

Julius Jelisejevas MD, Ali Husain MBBCh, Kevin Millar MD, Jonathon A. Leipsic MD, Janarthanan Sathananthan MBChB, MPH, Stéphane Cook MD, Mario Togni MD, Richard Cook MD, David A. Wood MD, John G. Webb MD

引用次数: 0

Mid-Term Outcomes of a Novel TAVR Device for Pure Aortic Regurgitation 一种用于单纯主动脉反流的新型TAVR装置的中期结果

IF 11.4 1区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS

JACC. Cardiovascular interventions

Pub Date : 2025-12-22 DOI: 10.1016/j.jcin.2025.10.017

Bowen Xiao MD , Lulu Liu MD , Yansong Guo MD , Jian Liu MD , Pengwei Yang MD , Yingbin Xiao MD , Jiancheng Xiu MD , Junjie Zhang MD , Zhenfei Fang MD , Gejun Zhang MD , Hong Jiang MD , Jinping Liu MD , Xianbao Liu MD , Yangyang Shen MS , Jian Yang MD , Haibo Zhang MD , Jun Shi MD , Jian Ye MD , Yingqiang Guo MD

Background

Patients with severe aortic regurgitation (AR) frequently face high surgical risks, rendering them ineligible for surgery. Transcatheter aortic valve replacement (TAVR) is now a primary therapy for aortic valve stenosis. However, its application in pure native AR has been relatively limited.

Objectives

The aim of this study was to evaluate the mid-term efficacy and safety of a novel self-expanding transfemoral TAVR device designed for treating pure native AR.

Methods

A prospective, single-arm clinical trial (ChiCTR2300075152) enrolled 110 consecutive patients with severe pure AR from 15 centers. The Pioneer Valve system with a rotatable feature and 3 independently angle-adjustable locators was used. Outcomes up to 1-year follow-up were reported per Valve Academic Research Consortium 3 criteria. The median clinical follow-up duration was 348 days (Q1-Q3: 342-357 days).

Results

The mean age was 73.37 ± 4.21 years, with a median Society of Thoracic Surgeons score of 5.97% (Q1-Q3: 4.04%-8.63%). Technical success was achieved in 109 of 110 cases (99.1%), and valve migration occurred in 1 case. Mean aortic valve gradient and mean effective orifice area at 30 days were 7.88 ± 2.7 mm Hg and 2.2 ± 0.64 cm², respectively. New permanent pacemaker implantation occurred in 23 of 105 cases (21.9%; 95% CI: 14.3%-29.8%). All-cause mortality was 3 of 110 (2.7%; 95% CI: 0.9%-8.3%) at 1 year. Significant improvements in NYHA functional class, Kansas City Cardiomyopathy Questionnaire score, and positive left ventricular remodeling were observed up to 1 year.

Conclusions

This study demonstrates that the Pioneer Valve provides a safe and effective alternative for high-risk or inoperable patients with severe pure AR, achieving favorable mid-term outcomes with stable hemodynamic performance.

背景：严重主动脉瓣反流（AR）患者往往面临较高的手术风险，使他们不适合手术。经导管主动脉瓣置换术（TAVR）现在是主动脉瓣狭窄的主要治疗方法。然而，它在纯原生AR中的应用相对有限。本研究的目的是评估一种新型自扩式经股TAVR装置用于治疗纯粹的先天性AR的中期疗效和安全性。方法一项前瞻性单臂临床试验（ChiCTR2300075152）招募了来自15个中心的110例连续的严重纯粹AR患者。先锋阀门系统具有可旋转功能和3个独立角度可调定位器。根据Valve学术研究联盟3的标准报告了随访1年的结果。中位临床随访时间为348天（Q1-Q3: 342-357天）。结果患者平均年龄为73.37±4.21岁，胸外科学会评分中位数为5.97%（第一季至第三季：4.04% ~ 8.63%）。110例患者中有109例（99.1%）技术成功，1例发生瓣膜移位。30天平均主动脉瓣梯度为7.88±2.7 mm Hg，平均有效开口面积为2.2±0.64 cm2。105例患者中有23例植入新的永久性起搏器（21.9%;95% CI: 14.3%-29.8%）。1年全因死亡率为3 / 110 （2.7%;95% CI: 0.9%-8.3%）。NYHA功能分级、堪萨斯城心肌病问卷评分和阳性左心室重构在1年内均有显著改善。结论本研究表明Pioneer瓣膜为高危或不能手术的严重纯AR患者提供了一种安全有效的替代方案，中期预后良好，血流动力学性能稳定。

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引用次数: 0

Toward Consensus in Angina With Nonobstructive Coronary Arteries Diagnostics and Beyond Trial and Error 心绞痛与非阻塞性冠状动脉诊断的共识和超越试验和错误

IF 11.4 1区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS

JACC. Cardiovascular interventions

Pub Date : 2025-12-22 DOI: 10.1016/j.jcin.2025.11.017

Olga Toleva MD, MPH

引用次数: 0

The Critical Role of IVI Criteria in Calcium Modification Post-ECLIPSE IVI标准在食管癌术后钙修饰中的关键作用

IF 11.4 1区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS

JACC. Cardiovascular interventions

Pub Date : 2025-12-22 DOI: 10.1016/j.jcin.2025.10.056

Kenji Sadamatsu MD, PhD, Yoshihiro Fukumoto MD, PhD

引用次数: 0

Left Atrial Appendage Occlusion Using a Novel System 使用新系统的左心耳闭塞：临床前评估和首次人体经验。

IF 11.4 1区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS

JACC. Cardiovascular interventions

Pub Date : 2025-12-22 DOI: 10.1016/j.jcin.2025.10.002

Felix Mahfoud MD, MA , Christian Ukena MD, MA , Philip D. Adamson MBChB, PhD, MSc, RACP, BHB, MPH , Matthew O’Connor MA, MB, BChir, BA, Dip Cardiac EP , Matthew Brooks MBBS, BMedSci , Lisa-Marie King BSc, MEd , John Thompson MB, BCh, BAO, MBA , Sandeep Panikker BSc, MBBS, PhD

Background

Atrial fibrillation is a major stroke risk, with >90% of thrombi originating from the left atrial appendage (LAA). Oral anticoagulation is effective, but many patients cannot use it long term. Current percutaneous LAA occlusion devices reduce stroke risk but are limited by device-related thrombus (DRT) and peridevice leak.

Objectives

The aim of this study was to assess the safety and performance of the novel Zenith LAA occlusion system in both preclinical canine models and a prospective first-in-human (FIH) clinical study.

Methods

A multistage evaluation included 3 preclinical trials in 17 canines (≤90-day follow-up) and a single-arm, prospective FIH study in 10 nonvalvular atrial fibrillation patients. This novel LAA device consists of a conformable Nitinol scaffold covered with a polyethylene terephthalate membrane, a self-closing central conduit to minimize exposed metal, and an independently deployed dynamic anchoring system. Primary imaging follow-up was 45-day transesophageal echocardiography.

Results

In a preclinical canine model (n = 17), explant analysis at 45 days demonstrated complete endothelialization with no evidence of DRT or significant inflammation. In the FIH study, 9 of 10 patients (90%) underwent successful implantation. The a priori primary safety endpoint of acute procedural success was achieved in 9 of 9 patients (100%), and the a priori primary performance endpoint of mechanical device closure at 45 days was also achieved in 9 of 9 patients (100%). At 45-day transesophageal echocardiography, all implants were stable, with complete protocol-defined LAA closure and no DRT. No device- or procedure-related serious adverse events occurred.

Conclusions

This novel LAA occlusion system demonstrated favorable early safety and performance in both preclinical and FIH evaluation. The novel design features enabled effective LAA sealing and absence of DRT, supporting further investigation in larger trials.

房颤是卒中的主要危险因素，90%的血栓起源于左心房附件（LAA）。口服抗凝是有效的，但许多患者不能长期使用。目前的经皮LAA闭塞装置可降低卒中风险，但受装置相关血栓（DRT）和装置周围泄漏的限制。本研究的目的是评估新型Zenith LAA闭塞系统在临床前犬模型和前瞻性首次人体（FIH）临床研究中的安全性和性能。方法多阶段评价包括3项临床前试验，17只犬（随访≤90天）和一项单臂前瞻性FIH研究，10例非瓣膜性房颤患者。这种新型LAA装置由一个覆盖有聚对苯二甲酸乙二醇酯膜的镍钛诺支架、一个自关闭的中央导管和一个独立部署的动态锚定系统组成。主要影像学随访为45天经食管超声心动图。结果在临床前犬模型（n = 17）中，45天的外植体分析显示完全内皮化，没有DRT或明显炎症的证据。在FIH研究中，10例患者中有9例（90%）成功植入。9例患者中有9例（100%）达到了急性手术成功的先验主要安全终点，9例患者中有9例（100%）也达到了45天机械装置关闭的先验主要性能终点。在第45天的经食管超声心动图中，所有植入物都是稳定的，具有完全的协议定义的LAA闭合，没有DRT。未发生与器械或手术相关的严重不良事件。结论该新型LAA闭塞系统在临床前和FIH评估中均表现出良好的早期安全性和性能。新颖的设计特点能够有效地密封LAA，并且没有DRT，支持在更大规模的试验中进一步研究。

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引用次数: 0

Percutaneous Removal of a Bullet From the Right Ventricle 经皮从右心室取出子弹。

IF 11.4 1区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS

JACC. Cardiovascular interventions

Pub Date : 2025-12-22 DOI: 10.1016/j.jcin.2025.09.002

David Elison MD , Richard Sheu MD , Christine J. Chung MD

引用次数: 0

Percutaneous Retrieval of a Migrated AVP From Segmental Pulmonary Artery and Balloon Pulmonary Angioplasty of Occluded Segments 经皮从肺动脉段取出移位的AVP及闭塞段的球囊肺动脉成形术

IF 11.4 1区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS

JACC. Cardiovascular interventions

Pub Date : 2025-12-22 DOI: 10.1016/j.jcin.2025.07.033

Nodari Maisuradze MD, Nikoloz Shekiladze MD, Wissam Jaber MD

引用次数: 0

Beyond a Universal Cutoff 超越普遍的切断

IF 11.4 1区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS

JACC. Cardiovascular interventions

Pub Date : 2025-12-22 DOI: 10.1016/j.jcin.2025.10.057

Ioannis Skalidis MD, PhD, Mario Togni MD, Stephane Cook MD, PhD

引用次数: 0

Simultaneous Closure of Left Ventricular Pseudoaneurysm and Mitral Valve Perforation Using Amplatzer Vascular Plug Amplatzer血管塞同时封闭左室假性动脉瘤及二尖瓣穿孔。

IF 11.4 1区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS

JACC. Cardiovascular interventions

Pub Date : 2025-12-22 DOI: 10.1016/j.jcin.2025.08.038

Taha Hatab MD , Krutarth Pandya MD , Beka Bakhtadze MD, Amar Krishnaswamy MD, Serge Harb MD, Samir Kapadia MD

引用次数: 0

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