JACC. Cardiovascular interventions最新文献

英文中文

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。

{"title":"Left Atrial Appendage Occlusion Using a Novel System","authors":"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","doi":"10.1016/j.jcin.2025.10.002","DOIUrl":"10.1016/j.jcin.2025.10.002","url":null,"abstract":"<div><h3>Background</h3><div>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.</div></div><div><h3>Objectives</h3><div>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.</div></div><div><h3>Methods</h3><div>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.</div></div><div><h3>Results</h3><div>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.</div></div><div><h3>Conclusions</h3><div>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.</div></div>","PeriodicalId":14688,"journal":{"name":"JACC. Cardiovascular interventions","volume":"18 24","pages":"Pages 3072-3083"},"PeriodicalIF":11.4,"publicationDate":"2025-12-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145357834","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

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

When 2D Speaks 3D 当2D说话3D：透视洞察阀门几何形状和血流动力学后TAVR。

IF 11.4 1区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS

JACC. Cardiovascular interventions

Pub Date : 2025-12-22 DOI: 10.1016/j.jcin.2025.10.020

Pier Pasquale Leone MD, MSc , Antonio Colombo MD , Azeem Latib MD

引用次数: 0

LAA Closure LAA关闭

IF 11.4 1区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS

JACC. Cardiovascular interventions

Pub Date : 2025-12-22 DOI: 10.1016/j.jcin.2025.11.007

Martin W. Bergmann MD

引用次数: 0

Real-Time Fluoroscopic Assessment of Underexpansion Predicts Hemodynamic Valve Deterioration Following TAVR With Balloon-Expandable Device 使用球囊膨胀装置进行TAVR后，实时透视评估扩张不足可预测血流动力学瓣膜恶化。

IF 11.4 1区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS

JACC. Cardiovascular interventions

Pub Date : 2025-12-22 DOI: 10.1016/j.jcin.2025.10.005

Domenico Angellotti MD , Nadir Elamin MD , Cyril Ferro MD , Daijiro Tomii MD , Jonas Lanz MD, MSc , Stefan Stortecky MD, MPH , Bashir Alaour MD , Joanna Bartkowiak MD , Daryoush Samim MD , Fabien Praz MD , David Reineke MD , Olivier Muller MD, PhD , Stephan Windecker MD , David Meier MD , Thomas Pilgrim MD, MSc

Background

The clinical sequelae of transcatheter heart valve (THV) underexpansion following transcatheter aortic valve replacement (TAVR) with balloon-expandable devices remain incompletely understood.

Objectives

The aim of this study was to investigate the impact of THV underexpansion on clinical outcomes among patients treated with balloon-expandable TAVR.

Methods

Consecutive patients undergoing transfemoral TAVR with the SAPIEN 3 and SAPIEN 3 Ultra systems in the prospective Bern TAVI registry were retrospectively evaluated. THV underexpansion was assessed on postimplantation fluoroscopic images and quantified using the validated commissural post height method. Significant THV underexpansion was defined as a reduction in stent frame midportion diameter ≥20% compared with the nominal diameter, using an optimal cutoff value determined by maximizing the log-rank statistic. The outcomes of interest were moderate or severe hemodynamic valve deterioration (HVD) according to the Valve Academic Research Consortium 3 and all-cause and cardiovascular mortality at 5-year follow-up.

Results

Among 1,043 patients (median age 81 years; Q1-Q3: 76-85 years; 34.6% women) undergoing TAVR with SAPIEN 3 or SAPIEN 3 Ultra valves between 2014 and 2022, 57 (5.4%) exhibited THV underexpansion. THV underexpansion ≥ 20% was associated with an increased risk for HVD at 5-year follow-up (subdistribution HR: 4.88; 95% CI: 2.18-10.97). The risk for HVD gradually increased with increasing degree of underexpansion (subdistribution HR: 1.94 per 5% increase; 95% CI: 1.42-2.79), with consistent findings across all valve sizes. Total aortic valve calcium volume, bicuspid anatomy, and valve iteration were significant predictors of THV underexpansion. At 862-day follow-up (Q1-Q3: 366-1,812 days), underexpansion was not associated with mortality.

Conclusions

Underexpansion of balloon-expandable THVs is associated with an increased risk for HVD at mid-term follow-up.

背景：经导管主动脉瓣置换术（TAVR）后经导管心脏瓣膜（THV）扩张不足的临床后遗症尚不完全清楚。目的：本研究的目的是探讨THV扩张不足对球囊扩张TAVR患者临床结果的影响。方法：回顾性评估伯尔尼前瞻性TAVI登记中连续使用SAPIEN 3和SAPIEN 3 Ultra系统进行经股动脉TAVR的患者。在植入后的透视图像上评估THV扩张不足，并使用经过验证的关节柱高度法进行量化。显著THV欠膨胀定义为支架支架中部直径与标称直径相比减小≥20%，使用最大log-rank统计量确定的最佳截止值。根据瓣膜学术研究联盟3，研究的结果是中度或重度瓣膜血流动力学恶化（HVD）和5年随访的全因死亡率和心血管死亡率。结果：2014年至2022年间，1043例患者（中位年龄81岁；第一季至第三季：76-85岁；34.6%女性）接受SAPIEN 3或SAPIEN 3 Ultra瓣膜TAVR，其中57例（5.4%）表现为THV扩张不足。5年随访时，THV扩张不足≥20%与HVD风险增加相关（亚分布HR: 4.88; 95% CI: 2.18-10.97）。随着扩张不足程度的增加，HVD的风险逐渐增加（亚分布HR：每增加5%增加1.94;95% CI: 1.42-2.79），所有瓣膜尺寸的结果都一致。主动脉瓣总钙容量、二尖瓣解剖结构和瓣膜迭代是THV扩张不足的重要预测因素。在862天的随访中（Q1-Q3: 366- 1812天），扩张不足与死亡率无关。结论：在中期随访中，球囊膨胀性thv扩张不足与HVD风险增加有关。

{"title":"Real-Time Fluoroscopic Assessment of Underexpansion Predicts Hemodynamic Valve Deterioration Following TAVR With Balloon-Expandable Device","authors":"Domenico Angellotti MD , Nadir Elamin MD , Cyril Ferro MD , Daijiro Tomii MD , Jonas Lanz MD, MSc , Stefan Stortecky MD, MPH , Bashir Alaour MD , Joanna Bartkowiak MD , Daryoush Samim MD , Fabien Praz MD , David Reineke MD , Olivier Muller MD, PhD , Stephan Windecker MD , David Meier MD , Thomas Pilgrim MD, MSc","doi":"10.1016/j.jcin.2025.10.005","DOIUrl":"10.1016/j.jcin.2025.10.005","url":null,"abstract":"<div><h3>Background</h3><div>The clinical sequelae of transcatheter heart valve (THV) underexpansion following transcatheter aortic valve replacement (TAVR) with balloon-expandable devices remain incompletely understood.</div></div><div><h3>Objectives</h3><div>The aim of this study was to investigate the impact of THV underexpansion on clinical outcomes among patients treated with balloon-expandable TAVR.</div></div><div><h3>Methods</h3><div>Consecutive patients undergoing transfemoral TAVR with the SAPIEN 3 and SAPIEN 3 Ultra systems in the prospective Bern TAVI registry were retrospectively evaluated. THV underexpansion was assessed on postimplantation fluoroscopic images and quantified using the validated commissural post height method. Significant THV underexpansion was defined as a reduction in stent frame midportion diameter ≥20% compared with the nominal diameter, using an optimal cutoff value determined by maximizing the log-rank statistic. The outcomes of interest were moderate or severe hemodynamic valve deterioration (HVD) according to the Valve Academic Research Consortium 3 and all-cause and cardiovascular mortality at 5-year follow-up.</div></div><div><h3>Results</h3><div>Among 1,043 patients (median age 81 years; Q1-Q3: 76-85 years; 34.6% women) undergoing TAVR with SAPIEN 3 or SAPIEN 3 Ultra valves between 2014 and 2022, 57 (5.4%) exhibited THV underexpansion. THV underexpansion ≥ 20% was associated with an increased risk for HVD at 5-year follow-up (subdistribution HR: 4.88; 95% CI: 2.18-10.97). The risk for HVD gradually increased with increasing degree of underexpansion (subdistribution HR: 1.94 per 5% increase; 95% CI: 1.42-2.79), with consistent findings across all valve sizes. Total aortic valve calcium volume, bicuspid anatomy, and valve iteration were significant predictors of THV underexpansion. At 862-day follow-up (Q1-Q3: 366-1,812 days), underexpansion was not associated with mortality.</div></div><div><h3>Conclusions</h3><div>Underexpansion of balloon-expandable THVs is associated with an increased risk for HVD at mid-term follow-up.</div></div>","PeriodicalId":14688,"journal":{"name":"JACC. Cardiovascular interventions","volume":"18 24","pages":"Pages 3024-3035"},"PeriodicalIF":11.4,"publicationDate":"2025-12-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145523602","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Comparison of International Expert Working Group Algorithms for Diagnosing Angina With Nonobstructive Coronary Arteries 国际专家工作组诊断冠心病心绞痛的算法比较

IF 11.4 1区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS

JACC. Cardiovascular interventions

Pub Date : 2025-12-22 DOI: 10.1016/j.jcin.2025.09.049

Christopher C.Y. Wong MBBS, PhD , Vedant S. Pargaonkar MD , Luke P. Dawson MBBS, PhD , Rahul R. Penumaka MBBS , Rajan Rehan MBBS , Andy S.C. Yong MBBS, PhD , Yasuhiro Honda MD , William F. Fearon MD , Ingela Schnittger MD , Jennifer A. Tremmel MD, MS

Background

Coronary function testing (CFT) protocols in patients with angina with nonobstructive coronary arteries (ANOCA) differ among expert working groups. The European Association of Percutaneous Cardiovascular Interventions (EAPCI) endorses testing for coronary artery spasm and microvascular dysfunction, while the Microvascular Network (MVN) recommends additional assessment for myocardial bridging and endothelial dysfunction.

Objectives

The aim of this study was to compare the diagnostic yield between the EAPCI and MVN algorithms in a large cohort of patients with ANOCA.

Methods

Fractional flow reserve, coronary flow reserve, index of microcirculatory resistance, intravascular ultrasound, acetylcholine provocation, and myocardial bridging assessment were performed in patients referred for clinically suspected ANOCA.

Results

Among 516 patients, the prevalence of ANOCA, obstructive coronary artery disease, and noncardiac chest pain was 53.5%, 20.9%, and 25.6%, respectively, according to the EAPCI algorithm, compared with 88.2%, 3.3%, and 8.5% according to the MVN algorithm (P < 0.001 for overall difference). Of 132 patients classified as noncardiac chest pain by the EAPCI algorithm, 66.7% were reclassified into an ANOCA endotype using the MVN algorithm. Similarly, 84.3% of 108 patients diagnosed with obstructive coronary artery disease using the EAPCI algorithm were reclassified into an ANOCA endotype by the MVN algorithm. The mean Seattle Angina Questionnaire summary score was significantly lower in patients with cardiac chest pain compared with those with noncardiac chest pain (51.0 vs 56.1; P = 0.030) as defined by the MVN algorithm.

Conclusions

The MVN algorithm results in a higher diagnostic yield for ANOCA endotypes compared with the EAPCI algorithm. Routine testing for myocardial bridging and endothelial dysfunction should be considered in patients with suspected ANOCA.

背景：专家工作组对非阻塞性冠状动脉（ANOCA）心绞痛患者的冠状动脉功能测试（CFT）方案存在差异。欧洲经皮心血管介入协会（EAPCI）支持检测冠状动脉痉挛和微血管功能障碍，而微血管网络（MVN）建议对心肌桥接和内皮功能障碍进行额外的评估。本研究的目的是比较EAPCI和MVN算法在ANOCA患者中的诊断率。方法对临床疑似ANOCA患者进行血流储备、冠状动脉血流储备、微循环阻力指数、血管内超声、乙酰胆碱激发、心肌桥桥评估。结果516例患者中，根据EAPCI算法，ANOCA、阻塞性冠状动脉疾病和非心源性胸痛的患病率分别为53.5%、20.9%和25.6%，而根据MVN算法，ANOCA、阻塞性冠状动脉疾病和非心源性胸痛的患病率分别为88.2%、3.3%和8.5%（总差异P <； 0.001）。在132例经EAPCI算法分类为非心源性胸痛的患者中，66.7%的患者经MVN算法重新分类为ANOCA内型。同样，使用EAPCI算法诊断为阻塞性冠状动脉疾病的108例患者中，84.3%被MVN算法重新分类为ANOCA内型。根据MVN算法的定义，心源性胸痛患者的平均西雅图心绞痛问卷总结评分明显低于非心源性胸痛患者（51.0 vs 56.1; P = 0.030）。结论与EAPCI算法相比，MVN算法对ANOCA内窥镜的诊断率更高。对于疑似ANOCA的患者，应考虑常规检测心肌桥和内皮功能障碍。

{"title":"Comparison of International Expert Working Group Algorithms for Diagnosing Angina With Nonobstructive Coronary Arteries","authors":"Christopher C.Y. Wong MBBS, PhD , Vedant S. Pargaonkar MD , Luke P. Dawson MBBS, PhD , Rahul R. Penumaka MBBS , Rajan Rehan MBBS , Andy S.C. Yong MBBS, PhD , Yasuhiro Honda MD , William F. Fearon MD , Ingela Schnittger MD , Jennifer A. Tremmel MD, MS","doi":"10.1016/j.jcin.2025.09.049","DOIUrl":"10.1016/j.jcin.2025.09.049","url":null,"abstract":"<div><h3>Background</h3><div>Coronary function testing (CFT) protocols in patients with angina with nonobstructive coronary arteries (ANOCA) differ among expert working groups. The European Association of Percutaneous Cardiovascular Interventions (EAPCI) endorses testing for coronary artery spasm and microvascular dysfunction, while the Microvascular Network (MVN) recommends additional assessment for myocardial bridging and endothelial dysfunction.</div></div><div><h3>Objectives</h3><div>The aim of this study was to compare the diagnostic yield between the EAPCI and MVN algorithms in a large cohort of patients with ANOCA.</div></div><div><h3>Methods</h3><div>Fractional flow reserve, coronary flow reserve, index of microcirculatory resistance, intravascular ultrasound, acetylcholine provocation, and myocardial bridging assessment were performed in patients referred for clinically suspected ANOCA.</div></div><div><h3>Results</h3><div>Among 516 patients, the prevalence of ANOCA, obstructive coronary artery disease, and noncardiac chest pain was 53.5%, 20.9%, and 25.6%, respectively, according to the EAPCI algorithm, compared with 88.2%, 3.3%, and 8.5% according to the MVN algorithm (<em>P</em> < 0.001 for overall difference). Of 132 patients classified as noncardiac chest pain by the EAPCI algorithm, 66.7% were reclassified into an ANOCA endotype using the MVN algorithm. Similarly, 84.3% of 108 patients diagnosed with obstructive coronary artery disease using the EAPCI algorithm were reclassified into an ANOCA endotype by the MVN algorithm. The mean Seattle Angina Questionnaire summary score was significantly lower in patients with cardiac chest pain compared with those with noncardiac chest pain (51.0 vs 56.1; <em>P</em> = 0.030) as defined by the MVN algorithm.</div></div><div><h3>Conclusions</h3><div>The MVN algorithm results in a higher diagnostic yield for ANOCA endotypes compared with the EAPCI algorithm. Routine testing for myocardial bridging and endothelial dysfunction should be considered in patients with suspected ANOCA.</div></div>","PeriodicalId":14688,"journal":{"name":"JACC. Cardiovascular interventions","volume":"18 24","pages":"Pages 2995-3005"},"PeriodicalIF":11.4,"publicationDate":"2025-12-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145802130","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Safety and Efficacy of a Novel Micro Net Carotid Stent System 新型微网状颈动脉支架系统的安全性和有效性：C-GUARDIANS试验的结果。

IF 11.4 1区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS

JACC. Cardiovascular interventions

Pub Date : 2025-12-22 DOI: 10.1016/j.jcin.2025.09.027

D. Christopher Metzger MD , Peter Soukas MD , Adnan Siddiqui MD, PhD , Piotr Pieniazek MD, PhD , Anish Thomas MD , Waclaw Kuczmik MD , Bruce H. Gray DO , Don Heck MD , Sean P. Lyden MD , J. Michael Bacharach MD , Gary Ansel MD , Mark Burket MD , Christina Brennan MD , Mena Schiano Lo Moriello EMBA , Raghu Kolluri MD , Patrick Verta MD , Gary S. Roubin MD, PhD , Piotr Musialek MD, DPhil , C-GUARDIANS Investigators

Background

The authors report the intention-to-treat results for the C-GUARDIANS (Safety and Efficacy of the CGuard™ Carotid Stent System in Carotid Artery Stenting) pivotal trial in carotid artery stenting patients considered high risk for carotid endarterectomy, treated with this novel stent and followed for 1 year.

Objectives

The authors sought to evaluate the safety and efficacy of the MicroNet-covered stent in treating patients with significant carotid stenosis at high risk of adverse events from carotid endarterectomy.

Methods

The trial is a prospective, multicenter, single-arm trial (NCT04900844). The primary endpoint was a composite of the incidence of death, all stroke, and myocardial infarction (DSMI) through 30 days postprocedure, and ipsilateral stroke from 31 to 365 days postprocedure. Secondary endpoints included the incidence of DSMI and of each individual component through 30 days, as well as the incidence of ipsilateral strokes through 30-day and 1-year follow-up. All events were adjudicated by an independent clinical events committee.

Results

Between July 2021 and June 2023, 316 patients with asymptomatic ≥80% or symptomatic ≥50% carotid lesions were treated with this novel stent at 24 sites in the United States and European Union using approved embolic protection systems. The DSMI rate through 30 days was 0.95% (3/316). DSMI at 30 days and ipsilateral stroke at 1 year was 1.93% (6/296). Target lesion revascularization through 1 year was 1.0% (3/299).

Conclusions

The C-GUARDIAN trial demonstrated low rates of DSMI through 30 days, and ipsilateral stroke through 1 year. No unexpected adverse device effects or unexpected serious adverse device effects were reported. These results demonstrate that carotid artery stenting with this novel stent is safe, effective and durable, and supports the potential neuroprotective properties of this unique micro mesh-covered stent.

背景：作者报告了C-GUARDIANS （CGuard™颈动脉支架系统在颈动脉支架植入术中的安全性和有效性）关键试验的意向治疗结果，该试验在颈动脉支架植入术患者中进行，这些患者被认为是颈动脉内膜切除术的高风险患者，使用这种新型支架治疗并随访1年。目的：作者试图评估微颗粒覆盖支架治疗颈动脉内膜切除术后不良事件高风险的颈动脉狭窄患者的安全性和有效性。方法：该试验是一项前瞻性、多中心、单臂试验（NCT04900844）。主要终点是术后30天死亡、全卒中和心肌梗死（DSMI）发生率以及术后31至365天同侧卒中发生率的综合指标。次要终点包括30天内DSMI和各单项成分的发生率，以及30天和1年随访期间同侧卒中的发生率。所有事件均由独立的临床事件委员会裁决。结果：在2021年7月至2023年6月期间，316例无症状≥80%或症状≥50%的颈动脉病变患者在美国和欧盟的24个地点使用这种新型支架治疗，使用批准的栓塞保护系统。30 d的DSMI率为0.95%（3/316）。30天的DSMI和1年的同侧卒中为1.93%（6/296）。1年目标病变血运重建率为1.0%（3/299）。结论：C-GUARDIAN试验显示30天内DSMI发生率低，1年内同侧卒中发生率低。没有意外的器械不良反应或意外的严重器械不良反应的报道。这些结果表明，使用这种新型支架进行颈动脉支架置入是安全、有效和持久的，并支持这种独特的微网覆盖支架潜在的神经保护特性。

{"title":"Safety and Efficacy of a Novel Micro Net Carotid Stent System","authors":"D. Christopher Metzger MD , Peter Soukas MD , Adnan Siddiqui MD, PhD , Piotr Pieniazek MD, PhD , Anish Thomas MD , Waclaw Kuczmik MD , Bruce H. Gray DO , Don Heck MD , Sean P. Lyden MD , J. Michael Bacharach MD , Gary Ansel MD , Mark Burket MD , Christina Brennan MD , Mena Schiano Lo Moriello EMBA , Raghu Kolluri MD , Patrick Verta MD , Gary S. Roubin MD, PhD , Piotr Musialek MD, DPhil , C-GUARDIANS Investigators","doi":"10.1016/j.jcin.2025.09.027","DOIUrl":"10.1016/j.jcin.2025.09.027","url":null,"abstract":"<div><h3>Background</h3><div>The authors report the intention-to-treat results for the C-GUARDIANS (Safety and Efficacy of the CGuard™ Carotid Stent System in Carotid Artery Stenting) pivotal trial in carotid artery stenting patients considered high risk for carotid endarterectomy, treated with this novel stent and followed for 1 year.</div></div><div><h3>Objectives</h3><div>The authors sought to evaluate the safety and efficacy of the MicroNet-covered stent in treating patients with significant carotid stenosis at high risk of adverse events from carotid endarterectomy.</div></div><div><h3>Methods</h3><div>The trial is a prospective, multicenter, single-arm trial (<span><span>NCT04900844</span><svg><path></path></svg></span>). The primary endpoint was a composite of the incidence of death, all stroke, and myocardial infarction (DSMI) through 30 days postprocedure, and ipsilateral stroke from 31 to 365 days postprocedure. Secondary endpoints included the incidence of DSMI and of each individual component through 30 days, as well as the incidence of ipsilateral strokes through 30-day and 1-year follow-up. All events were adjudicated by an independent clinical events committee.</div></div><div><h3>Results</h3><div>Between July 2021 and June 2023, 316 patients with asymptomatic ≥80% or symptomatic ≥50% carotid lesions were treated with this novel stent at 24 sites in the United States and European Union using approved embolic protection systems. The DSMI rate through 30 days was 0.95% (3/316). DSMI at 30 days and ipsilateral stroke at 1 year was 1.93% (6/296). Target lesion revascularization through 1 year was 1.0% (3/299).</div></div><div><h3>Conclusions</h3><div>The C-GUARDIAN trial demonstrated low rates of DSMI through 30 days, and ipsilateral stroke through 1 year. No unexpected adverse device effects or unexpected serious adverse device effects were reported. These results demonstrate that carotid artery stenting with this novel stent is safe, effective and durable, and supports the potential neuroprotective properties of this unique micro mesh-covered stent.</div></div>","PeriodicalId":14688,"journal":{"name":"JACC. Cardiovascular interventions","volume":"18 24","pages":"Pages 3087-3097"},"PeriodicalIF":11.4,"publicationDate":"2025-12-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145654215","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

首页上一页

类型

全部化学•材料生命科学医学物理工程技术环境•农林材料科学地球科学法学管理学化学环境科学与生态学计算机科学教育学经济学农林科学人文科学生物学数学物理与天体物理心理学综合性期刊其他工业工程理学历史学农学文学信息工程

数据库

全部 ACS Publications Elsevier ieeexplore Springer The Royal Society of Chemistry Wiley

期刊

JACC. Cardiovascular interventions

全部 Acc. Chem. Res. ACS Applied Bio Materials ACS Appl. Electron. Mater. ACS Appl. Energy Mater. ACS Appl. Mater. Interfaces ACS Appl. Nano Mater. ACS Appl. Polym. Mater. ACS BIOMATER-SCI ENG ACS Catal. ACS Cent. Sci. ACS Chem. Biol. ACS Chemical Health & Safety ACS Chem. Neurosci. ACS Comb. Sci. ACS Earth Space Chem. ACS Energy Lett. ACS Infect. Dis. ACS Macro Lett. ACS Mater. Lett. ACS Med. Chem. Lett. ACS Nano ACS Omega ACS Photonics ACS Sens. ACS Sustainable Chem. Eng. ACS Synth. Biol. Anal. Chem. BIOCHEMISTRY-US Bioconjugate Chem. BIOMACROMOLECULES Chem. Res. Toxicol. Chem. Rev. Chem. Mater. CRYST GROWTH DES ENERG FUEL Environ. Sci. Technol. Environ. Sci. Technol. Lett. Eur. J. Inorg. Chem. IND ENG CHEM RES Inorg. Chem. J. Agric. Food. Chem. J. Chem. Eng. Data J. Chem. Educ. J. Chem. Inf. Model. J. Chem. Theory Comput. J. Med. Chem. J. Nat. Prod. J PROTEOME RES J. Am. Chem. Soc. LANGMUIR MACROMOLECULES Mol. Pharmaceutics Nano Lett. Org. Lett. ORG PROCESS RES DEV ORGANOMETALLICS J. Org. Chem. J. Phys. Chem. J. Phys. Chem. A J. Phys. Chem. B J. Phys. Chem. C J. Phys. Chem. Lett. Analyst Anal. Methods Biomater. Sci. Catal. Sci. Technol. Chem. Commun. Chem. Soc. Rev. CHEM EDUC RES PRACT CRYSTENGCOMM Dalton Trans. Energy Environ. Sci. ENVIRON SCI-NANO ENVIRON SCI-PROC IMP ENVIRON SCI-WAT RES Faraday Discuss. Food Funct. Green Chem. Inorg. Chem. Front. Integr. Biol. J. Anal. At. Spectrom. J. Mater. Chem. A J. Mater. Chem. B J. Mater. Chem. C Lab Chip Mater. Chem. Front. Mater. Horiz. MEDCHEMCOMM Metallomics Mol. Biosyst. Mol. Syst. Des. Eng. Nanoscale Nanoscale Horiz. Nat. Prod. Rep. New J. Chem. Org. Biomol. Chem. Org. Chem. Front. PHOTOCH PHOTOBIO SCI PCCP Polym. Chem.

﹀