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Impact of Central vs. Noncentral Predominant Jet Location on Clinical Outcomes: Results From the EXPANDed Studies 中心与非中心主要喷流位置对临床结果的影响:来自扩展研究的结果
IF 2.8 Q3 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2025-10-25 DOI: 10.1016/j.shj.2025.100743
Jason H. Rogers MD , Matthew J. Price MD , Gagan D. Singh MD , Paul Mahoney MD , Mathew Williams MD , Paolo Denti MD , Anita Asgar MD , Janani Aiyer MS , Rong Huang MS , Jose Luis Zamorano MD , Federico M. Asch MD , Francesco Maisano MD , Saibal Kar MD , Ralph Stephan von Bardeleben MD , Evelio Rodriguez MD

Background

Mitral transcatheter edge-to-edge repair (M-TEER) is a treatment option for patients with severe mitral regurgitation (MR) at a high surgical risk. Although most MR involves central A2P2 jets, a subset present with noncentral jets, which may introduce procedural complexity and influence outcomes. The objective of the study was to evaluate the impact of main MR jet location (central [A2P2] versus noncentral [A1/P1 or A3/P3]) on procedural success and clinical outcomes following M-TEER.

Methods

This analysis used the EXPANDed data set, which included patients undergoing M-TEER with MitraClip G3/G4 systems and echocardiographic core laboratory-assessed main MR jet location. One-year clinical, echocardiographic, and functional outcomes were assessed.

Results

A total of 1785 patients had main jets at A2P2 and 81 at A1P1 or A3P3 (non-A2P2). Non-A2P2 patients more frequently had degenerative MR, prior mitral valve procedures, and better left ventricular function. Procedural success was high and comparable (A2P2: 95.9%, non-A2P2: 92.5%; p = 0.15), with low 30-day major adverse event rates in both (A2P2: 4.2%, non-A2P2: 7.4%; p = 0.16). MR ≤ 1+ was achieved in both groups at 1 year (A2P2: 91%, non-A2P2: 84%, p = 0.11). New York Heart Association class ≤ II improved through 1 year in both groups (A2P2: 81%, non-A2P2: 88%). Kansas City Cardiomyopathy Questionnaire overall summary improved significantly with no difference between groups at 1 year (A2P2: Δ13 points, non-A2P2: Δ20 points). One-year all-cause mortality was similar (10.7 vs. 13.7%; p = 0.47).

Conclusions

In this largest analysis to date of patients with severe MR, main MR jet location did not affect the safety or effectiveness of the MitraClip system. These findings support the use of M-TEER across a range of anatomical presentations, including non-A2P2 MR jets.
背景:二尖瓣经导管边缘到边缘修复(M-TEER)是严重二尖瓣返流(MR)高手术风险患者的一种治疗选择。尽管大多数MR涉及中央A2P2射流,但也有一部分存在非中心射流,这可能会引入程序复杂性并影响结果。该研究的目的是评估MR主要喷射位置(中央[A2P2]与非中央[A1/P1或A3/P3])对M-TEER手术成功和临床结果的影响。方法采用扩展数据集,包括使用MitraClip G3/G4系统进行M-TEER的患者和超声心动图核心实验室评估的主要MR射流位置。评估一年的临床、超声心动图和功能结果。结果1785例患者主要喷流位于A2P2, 81例位于A1P1或A3P3(非A2P2)。非a2p2患者更常发生退行性MR,既往二尖瓣手术,左心室功能更好。手术成功率高且相当(A2P2: 95.9%,非A2P2: 92.5%, p = 0.15),两组患者30天主要不良事件发生率均较低(A2P2: 4.2%,非A2P2: 7.4%, p = 0.16)。两组患者1年时MR≤1+ (A2P2: 91%,非A2P2: 84%, p = 0.11)。两组的纽约心脏协会分级≤II的患者在1年内均有改善(A2P2组:81%,非A2P2组:88%)。堪萨斯城心肌病调查问卷总体总结在1年后显著改善,组间无差异(A2P2: Δ13分,非A2P2: Δ20分)。一年全因死亡率相似(10.7 vs. 13.7%; p = 0.47)。结论:在这项迄今为止对严重MR患者进行的最大规模分析中,主要MR喷射位置不影响MitraClip系统的安全性和有效性。这些发现支持M-TEER在一系列解剖表现中的应用,包括非a2p2 MR喷气机。
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引用次数: 0
Impact of Transvalvular Cardiac Implantable Electronic Devices on Outcomes Following Tricuspid Transcatheter Edge-to-Edge Repair 经瓣心脏植入式电子装置对三尖瓣经导管边缘到边缘修复后预后的影响
IF 2.8 Q3 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2025-10-24 DOI: 10.1016/j.shj.2025.100744
Salman Zahid MD , Muhammad Ahmad MBBS , Saket Sanghai MD , Charles A. Henrikson MD , Scott Chadderdon MD , Firas Zahr MD
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引用次数: 0
Transcatheter Versus Surgical Aortic Valve Replacement in Women of Childbearing Age in the United States 美国育龄妇女经导管与手术主动脉瓣置换术的比较
IF 2.8 Q3 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2025-10-24 DOI: 10.1016/j.shj.2025.100746
Mahmoud Ismayl MBBS , Hasaan Ahmed MD , Andrew M. Goldsweig MD, MS , Mayra Guerrero MD

Background

Women of childbearing age occasionally require aortic valve replacement (AVR), sometimes performed with transcatheter AVR (TAVR). Outcomes of TAVR versus surgical AVR (SAVR) in women of childbearing age have not been evaluated. We aimed to evaluate the contemporary use and outcomes of TAVR versus SAVR in women of childbearing age in the United States.

Methods

Women aged 18-50 years hospitalized for isolated AVR were identified in the Nationwide Readmissions Database (2016-2022). In-hospital outcomes of TAVR versus SAVR were compared using propensity-score matching. Readmissions were compared using the Cox proportional hazards regression model.

Results

Of 6926 weighted hospitalizations for isolated AVR in women aged 18-50 years, 897 (13.0%) included TAVR, and 6029 (87.0%) included SAVR. From 2016-2022, the proportion of AVR performed using TAVR increased from 7.4% to 16.3% in women aged 18-50 years (ptrend<0.001). Compared with SAVR, TAVR was associated with lower in-hospital mortality (<1.4 vs. 3.5%, p = 0.03), acute kidney injury (9.0 vs. 16.8%, p = 0.002), and need for blood transfusion (7.1 vs. 19.1%, p ​< ​0.001), but higher heart block (23.5 vs. 9.7%, p ​< ​0.001) and vascular complications (5.0 vs. 2.1%, p = 0.03). Length of stay was shorter (2 vs. 7 days, p ​< ​0.001) and nonhome discharges were lower (16.2 vs. 56.7%, p ​< ​0.001) with TAVR compared with SAVR. Ninety-day all-cause readmissions were similar between TAVR and SAVR (12.6 vs. 13.3%, p = 0.78).

Conclusions

This nationwide observational analysis found that TAVR is increasingly performed among women aged 18-50 years with lower in-hospital mortality and resource utilization and similar readmissions compared with SAVR.
育龄妇女偶尔需要主动脉瓣置换术(AVR),有时需要经导管主动脉瓣置换术(TAVR)。育龄妇女TAVR与手术AVR (SAVR)的结果尚未得到评估。我们的目的是评估TAVR与SAVR在美国育龄妇女中的当代使用和结果。方法在全国再入院数据库(2016-2022)中确定年龄为18-50岁的孤立性AVR住院女性。使用倾向-评分匹配比较TAVR和SAVR的住院结果。再入院率采用Cox比例风险回归模型进行比较。结果6926例18-50岁女性孤立性AVR加权住院患者中,897例(13.0%)为TAVR, 6029例(87.0%)为SAVR。从2016-2022年,18-50岁女性中使用TAVR进行AVR的比例从7.4%增加到16.3%(趋势<;0.001)。与SAVR相比,TAVR与较低的住院死亡率(1.4比3.5%,p = 0.03)、急性肾损伤(9.0比16.8%,p = 0.002)和输血需求(7.1比19.1%,p < 0.001)相关,但与较高的心脏传导阻滞(23.5比9.7%,p < 0.001)和血管并发症(5.0比2.1%,p = 0.03)相关。与SAVR相比,TAVR的住院时间更短(2天vs. 7天,p < 0.001),非家庭出院率更低(16.2天vs. 56.7%, p < 0.001)。TAVR和SAVR的90天全因再入院率相似(12.6% vs. 13.3%, p = 0.78)。结论:这项全国性的观察性分析发现,与SAVR相比,TAVR越来越多地在18-50岁的女性中进行,其住院死亡率和资源利用率较低,再入院率相似。
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引用次数: 0
Transcatheter Aortic Valve Implantation in Latin America: Lessons From Chile’s Limited Access 经导管主动脉瓣植入术在拉丁美洲:从智利有限通道的经验教训
IF 2.8 Q3 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2025-10-22 DOI: 10.1016/j.shj.2025.100745
Gonzalo J. Martínez MD, MPhil , Marilaura Nuñez MD , Olivia Sanhueza MSc , Pedro Villablanca MD , Mario Araya MD , Felipe Norambuena MD , Juan Francisco Bulnes MD , Alejandro Martínez MD , Paula Muñoz-Venturelli MD, PhD
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引用次数: 0
Quantification of Alpha-Gal Expression in Commercial BioProsthetic Heart Valves and Its Potential Mitigation 商业生物瓣膜α - gal表达的量化及其潜在的缓解作用
IF 2.8 Q3 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2025-10-13 DOI: 10.1016/j.shj.2025.100739
Andrea Colli MD , Peter Zilla MD , Antonio Maria Calafiore MD , Massimo Padalino MD , Filippo Naso MLT, BSc , Isaac George MD

Background and Aims

Bioprosthetic heart valves (BHVs) are inherently susceptible to structural degeneration, driven by a combination of mechanical stress, lipid infiltration, glutaraldehyde-induced crosslinking instability, and progressive calcification. Recent evidence has implicated the αGal antigen (galactose-α-1,3-galactose) as an additional contributor to BHV deterioration through activation of innate immune pathways. The present study aims to: 1) perform a quantitative assessment of the residual presence of xenoantigens, specifically αGal, in a range of commercial BHV models; 2) evaluate the efficacy of an experimental polyphenol-based treatment in neutralizing these antigenic determinants; and 3) investigate the long-term stability of glutaraldehyde fixation concerning the potential re-exposure of αGal epitopes.

Methods

Twelve distinct BHV models were subjected to in vitro analysis for αGal antigen quantification both before and following application of an experimental polyphenol treatment. Additionally, glutaraldehyde-fixed bovine pericardial tissues were incubated in a physiologically mimetic, blood-like environment for up to 9 years in real-time to simulate the long-term behavior of BHV materials and assess antigen unmasking associated with glutaraldehyde degradation.

Results

The average count of the αGal epitope in original pericardial valve models was 4.18 ± 0.72 × 1011/10 mg of tissue, whereas porcine valve-derived prostheses exhibited a higher mean value of 8.51 ± 2.17 × 1011/10 mg. Treatment with the polyphenol formulation resulted in a marked reduction (approximately 99%) in detectable αGal epitopes. Furthermore, glutaraldehyde fixed pericardial tissues subjected to prolonged incubation demonstrated up to 60% re-exposure of previously masked αGal antigens after 9 years, consistent with a progressive compromise of glutaraldehyde crosslinking integrity.

Conclusion

The data confirm that commercially available BHVs retain a substantial immunogenic burden attributable to αGal xenoantigens. Importantly, the overtime degradation of glutaraldehyde crosslinks facilitates the gradual re-exhibition of these epitopes, potentially undermining long-term valve performance. The pronounced efficacy of polyphenol-based treatment in inhibiting αGal antigens highlights its promise as a biocompatibility-enhancing pretreatment strategy for next-generation BHVs.
背景和目的生物人工心脏瓣膜(bhv)在机械应力、脂质浸润、戊二醛诱导的交联不稳定性和进行性钙化的共同作用下,天生就容易发生结构退化。最近的证据表明,αGal抗原(半乳糖-α-1,3-半乳糖)是通过激活先天免疫途径导致BHV恶化的另一个因素。本研究旨在:1)在一系列商业BHV模型中定量评估异种抗原,特别是αGal的残留存在;2)评估基于多酚的实验性治疗在中和这些抗原决定因子方面的功效;3)研究戊二醛固定对αGal表位再暴露的长期稳定性。方法采用体外α - gal抗原定量分析方法,对12种不同BHV模型进行多酚处理前后α - gal抗原定量分析。此外,将戊二醛固定的牛心包组织在生理模拟、类似血液的环境中实时培养长达9年,以模拟BHV材料的长期行为,并评估与戊二醛降解相关的抗原揭露。结果原始心包瓣膜模型αGal表位的平均计数为4.18±0.72 × 1011/10 mg,猪瓣膜模型αGal表位的平均值为8.51±2.17 × 1011/10 mg。用多酚制剂处理导致可检测的αGal表位显著减少(约99%)。此外,经长时间培养的戊二醛固定心包组织显示,在9年后,高达60%的先前被掩盖的αGal抗原再次暴露,这与戊二醛交联完整性的进行性损害一致。结论市售bhv具有αGal异种抗原的免疫原性负担。重要的是,戊二醛交联的长期降解促进了这些表位的逐渐重新展示,潜在地破坏了长期的阀门性能。基于多酚的治疗在抑制αGal抗原方面的显著效果突出了其作为下一代bhv生物相容性增强预处理策略的前景。
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引用次数: 0
Long-Term Outcomes of Indirect Annuloplasty for Functional Mitral Regurgitation: Interim Results From the CINCH Registry 间接环成形术治疗功能性二尖瓣反流的长期结果:来自CINCH注册中心的中期结果
IF 2.8 Q3 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2025-10-12 DOI: 10.1016/j.shj.2025.100738
Stephan Fichtlscherer MD , Sergiu Hicea MD , Fabian Barbieri MD , Murat Yildiz MD , Elvis Ypi MD , Humam Al-Kadah MD , Dietrich Pfeiffer MD , Steven L. Goldberg MD , Klaus K. Witte MD , Horst Sievert MD , CINCH Investigators

Background

Functional mitral regurgitation (FMR) has limited effective treatment options. As a transcatheter indirect annuloplasty, the Carillon Mitral Contour System reduces FMR and improves symptoms, but long-term safety and effectiveness are incompletely characterized.

Methods

This prospective, multicenter CINCH registry enrolled heart failure patients with FMR treated with the Carillon Mitral Contour System across 22 centers in Germany. Main outcomes included change in New York Heart Association (NYHA) class and MR severity, heart failure hospitalization (HFH), all-cause mortality rates, and device- or procedure-related serious adverse events at 1 year. Median follow-up was 2.0 years (range, 0-5 years).

Results

Among 228 patients (age 78 ± 8 years; 51% female; 51% with left ventricular ejection fraction ≥50%), Carillon implantation improved clinical and echocardiographic variables. The rate of NYHA class III or IV symptoms decreased from 81 to 29% at 1 year, and the rate of moderate-to-severe MR (grade 3+/4+) decreased from 84 to 9% at 1 year, with ≥92% showing stable or improved NYHA class and ≥97% showing stable or improved MR grade over 5 years. Decreases in MR grade were associated with improvements in NYHA class (p = 0.048). Kaplan–Meier estimates over 5 years were 54.0% for HFH, 46.9% for all-cause mortality, and 68.3% for the composite of HFH or death. The proportion of patients experiencing any serious device- or procedure-related serious adverse event at 1 year was 1.8%.

Conclusions

The CINCH registry provides real-world evidence supporting the long-term safety, effectiveness, and durability of the Carillon Mitral Contour System in treating FMR.
背景:功能性二尖瓣反流(FMR)的有效治疗方案有限。Carillon二尖瓣轮廓系统作为一种经导管间接环成形术,可减少FMR并改善症状,但其长期安全性和有效性尚不完全明确。这项前瞻性、多中心的CINCH注册研究纳入了德国22个中心接受Carillon二尖冠轮廓系统治疗的FMR心衰患者。主要结局包括纽约心脏协会(NYHA)分级和MR严重程度的变化、心力衰竭住院(HFH)、全因死亡率以及1年内与器械或手术相关的严重不良事件。中位随访时间为2.0年(范围0-5年)。结果228例患者(年龄78±8岁,51%女性,51%左室射血分数≥50%),Carillon植入改善了临床和超声心动图指标。NYHA III级或IV级症状的发生率在1年内从81%下降到29%,中度至重度MR(3+/4+级)的发生率在1年内从84%下降到9%,≥92%显示稳定或改善的NYHA分级,≥97%显示稳定或改善的5年MR分级。MR分级的降低与NYHA分级的改善相关(p = 0.048)。Kaplan-Meier估计5年内HFH死亡率为54.0%,全因死亡率为46.9%,HFH或死亡复合死亡率为68.3%。1年内发生任何与器械或手术相关的严重不良事件的患者比例为1.8%。CINCH注册提供了支持Carillon二尖瓣轮廓系统治疗FMR的长期安全性、有效性和耐久性的真实证据。
{"title":"Long-Term Outcomes of Indirect Annuloplasty for Functional Mitral Regurgitation: Interim Results From the CINCH Registry","authors":"Stephan Fichtlscherer MD ,&nbsp;Sergiu Hicea MD ,&nbsp;Fabian Barbieri MD ,&nbsp;Murat Yildiz MD ,&nbsp;Elvis Ypi MD ,&nbsp;Humam Al-Kadah MD ,&nbsp;Dietrich Pfeiffer MD ,&nbsp;Steven L. Goldberg MD ,&nbsp;Klaus K. Witte MD ,&nbsp;Horst Sievert MD ,&nbsp;CINCH Investigators","doi":"10.1016/j.shj.2025.100738","DOIUrl":"10.1016/j.shj.2025.100738","url":null,"abstract":"<div><h3>Background</h3><div>Functional mitral regurgitation (FMR) has limited effective treatment options. As a transcatheter indirect annuloplasty, the Carillon Mitral Contour System reduces FMR and improves symptoms, but long-term safety and effectiveness are incompletely characterized.</div></div><div><h3>Methods</h3><div>This prospective, multicenter CINCH registry enrolled heart failure patients with FMR treated with the Carillon Mitral Contour System across 22 centers in Germany. Main outcomes included change in New York Heart Association (NYHA) class and MR severity, heart failure hospitalization (HFH), all-cause mortality rates, and device- or procedure-related serious adverse events at 1 year. Median follow-up was 2.0 years (range, 0-5 years).</div></div><div><h3>Results</h3><div>Among 228 patients (age 78 ± 8 years; 51% female; 51% with left ventricular ejection fraction ≥50%), Carillon implantation improved clinical and echocardiographic variables. The rate of NYHA class III or IV symptoms decreased from 81 to 29% at 1 year, and the rate of moderate-to-severe MR (grade 3+/4+) decreased from 84 to 9% at 1 year, with ≥92% showing stable or improved NYHA class and ≥97% showing stable or improved MR grade over 5 years. Decreases in MR grade were associated with improvements in NYHA class (<em>p</em> = 0.048). Kaplan–Meier estimates over 5 years were 54.0% for HFH, 46.9% for all-cause mortality, and 68.3% for the composite of HFH or death. The proportion of patients experiencing any serious device- or procedure-related serious adverse event at 1 year was 1.8%.</div></div><div><h3>Conclusions</h3><div>The CINCH registry provides real-world evidence supporting the long-term safety, effectiveness, and durability of the Carillon Mitral Contour System in treating FMR.</div></div>","PeriodicalId":36053,"journal":{"name":"Structural Heart","volume":"9 12","pages":"Article 100738"},"PeriodicalIF":2.8,"publicationDate":"2025-10-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145570580","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Managing Hostile Aortic Anatomies Using an Extended-Length Introducer Sheath During Transfemoral Transcatheter Aortic Valve Replacement: Rationale and Clinical Outcomes 在经股主动脉瓣置换术中使用延长长度的导管鞘处理不良的主动脉解剖:原理和临床结果
IF 2.8 Q3 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2025-10-08 DOI: 10.1016/j.shj.2025.100737
Yusuke Kobari MD, PhD , Davorka Lulic MD , Arif A. Khokhar BM, BCh, MA , Yinghao Lim MD , Tau Sarra Hartikainen MD , Laurence Campens MD, PhD , Yannick Willemen MD, PhD , Gintautas Bieliauskas MD , Ole De Backer MD, PhD

Background

Transfemoral (TF) access is the safest and guideline-recommended approach for transcatheter aortic valve replacement (TAVR). However, in patients with hostile aortic anatomies, the procedure may carry increased risks of vascular or cerebrovascular complications. The objective of this article is, therefore, to evaluate the safety and efficacy of using the extended-length DrySeal Flex introducer sheath (Gore, USA) for TF-TAVR in high-risk patients with challenging aortic anatomies.

Methods

We conducted a retrospective, single-center cohort study including all consecutive patients who underwent TF-TAVR with the 65-cm DrySeal sheath between 2021 and 2025. We analyzed the indications for sheath use and the following clinical outcomes: all-cause mortality, stroke, and major vascular complications as defined by Valve Academic Research Consortium-3 criteria.

Results

The 65-cm DrySeal sheath was used in 200 patients (median age 80 years; median Society of Thoracic Surgeons score 5.4%) out of 2430 (8.2%) TF-TAVR procedures performed. This approach was selected to address challenges posed by aortic arch calcification (28%), heavily atheromatous or shaggy aorta (20%), acute aortic angulation (26%), tortuosity (36%), and aortic coarctation (8%). In this high-risk cohort, all-cause mortality was 0.5%, stroke occurred in 1.5% (including 0.5% with disabling stroke), and major vascular complications were observed in 1.0%. These outcomes were comparable to those seen in lower-risk patients undergoing TF-TAVR using conventional approaches.

Conclusions

In patients with hostile aortic anatomies, the extended-length DrySeal Flex introducer sheath facilitated safe and effective TAV delivery and was associated with a low rate of periprocedural complications, including cerebrovascular events. Its use may help mitigate the risks traditionally associated with hostile aortic anatomies.
背景:经股动脉(TF)通道是经导管主动脉瓣置换术(TAVR)最安全、指南推荐的入路。然而,对于主动脉解剖不良的患者,手术可能会增加血管或脑血管并发症的风险。因此,本文的目的是评估在主动脉解剖结构具有挑战性的高危患者中使用延长长度的DrySeal Flex导入鞘(Gore, USA)治疗TF-TAVR的安全性和有效性。方法:我们进行了一项回顾性、单中心队列研究,包括所有在2021年至2025年期间连续接受65 cm DrySeal鞘TF-TAVR的患者。我们分析了护套使用的适应症和以下临床结果:全因死亡率、卒中和瓣膜学术研究联盟-3标准定义的主要血管并发症。结果在2430例(8.2%)TF-TAVR手术中,200例患者(中位年龄80岁,胸外科学会中位评分5.4%)使用65 cm DrySeal鞘。选择这种方法来解决主动脉弓钙化(28%)、严重动脉粥样硬化或主动脉粗糙(20%)、急性主动脉成角(26%)、扭曲(36%)和主动脉缩窄(8%)带来的挑战。在这个高风险队列中,全因死亡率为0.5%,卒中发生率为1.5%(包括0.5%致残性卒中),主要血管并发症发生率为1.0%。这些结果与使用传统方法接受TF-TAVR的低风险患者的结果相当。结论:在主动脉解剖不良的患者中,延长长度的DrySeal Flex导入鞘有助于安全有效的TAV输送,并且术中并发症(包括脑血管事件)发生率低。它的使用可能有助于减轻传统上与主动脉解剖不良相关的风险。
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引用次数: 0
Left Atrial Appendage Occlusion Using the Amplatzer Amulet Device in High-Risk Patients With Atrial Fibrillation Undergoing Transcatheter Aortic Valve Intervention: A Randomized Pilot Study 使用Amplatzer护身符装置阻断高危心房颤动患者经导管主动脉瓣介入治疗的左心耳:一项随机先导研究
IF 2.8 Q3 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2025-10-08 DOI: 10.1016/j.shj.2025.100735
Philipp Jakob MD , Priska Heinz MSc , Yiqi Gong MD , Mi Chen MD , Ronald K. Binder MD , Ulrike Held PhD , Maurizio Taramasso MD, PhD , Francesco Paneni MD, PhD , Philipp Schuetz MD, MPH , Philipp K. Haager MD , Markus Kasel MD , Giovanni Pedrazzini MD , Stephan Windecker MD , Marco Moccetti MD , Thomas Pilgrim MD, MSc , Thomas F. Lüscher MD, PhD , Barbara E. Stähli MD, MPH , Fabian Nietlispach MD, PhD , TAVI-LAAO Investigators

Background

Patients with severe aortic stenosis and atrial fibrillation (AF) undergoing transcatheter aortic valve intervention (TAVI) are at increased risk of bleeding and cerebrovascular events. This investigator-initiated, randomized, multicenter, open-label pilot study assessed left atrial appendage occlusion (LAAO) in patients with AF undergoing TAVI.

Methods

Patients were randomly assigned to LAAO (TAVI + LAAO) or standard medical therapy (SMT) (TAVI + SMT). The primary endpoint was a composite of cerebrovascular events, peripheral embolism, life-threatening/disabling/major bleeding, or cardiovascular mortality at 1 year. A sensitivity analysis was performed in the per-protocol population.

Results

Eighty-one patients (Society of Thoracic Surgeons score: 9.0% ± 5.4%) were enrolled. The primary endpoint occurred in 13 patients (33%) in the TAVI + LAAO group and in 15 patients (37%) in the TAVI + SMT group (adjusted odds ratio [OR], 0.87; 95% CI: 0.32-2.29, p = 0.77). Bleeding rates were comparable between TAVI + LAAO (13%) and TAVI + SMT (17%), with absent nonprocedural bleeding in the TAVI + LAAO group and 5 gastrointestinal bleedings in TAVI + SMT, and cerebrovascular events did not significantly differ between groups (10% in TAVI + LAAO vs. 2.4% in TAVI + SMT). In the per-protocol analysis, occurrence of the primary endpoint was comparable between groups (adjusted OR, 0.55; 95% CI: 0.18-1.56, p = 0.27) with cerebrovascular events in 5.6% and 2.4%, and bleeding events in 8.3% and 17% for TAVI + LAAO and TAVI + SMT, respectively.

Conclusions

This pilot study suggests that among high-risk patients with AF undergoing TAVI, a strategy of a combined procedure with LAAO and early cessation of oral anticoagulation overall showed similar rates of the primary end point as compared to a single TAVI procedure (NCT03088098).
背景:严重主动脉瓣狭窄和心房颤动(AF)患者接受经导管主动脉瓣介入治疗(TAVI)时出血和脑血管事件的风险增加。这项由研究者发起、随机、多中心、开放标签的先导研究评估了房颤患者行TAVI时左心耳闭塞(LAAO)的情况。方法将患者随机分为LAAO组(TAVI + LAAO)和标准药物治疗组(TAVI + SMT)。主要终点是脑血管事件、外周栓塞、危及生命/致残/大出血或1年心血管死亡率的综合指标。在每个方案人群中进行敏感性分析。结果入选81例患者(胸外科学会评分:9.0%±5.4%)。主要终点发生在TAVI + LAAO组13例患者(33%)和TAVI + SMT组15例患者(37%)(校正优势比[OR], 0.87; 95% CI: 0.32-2.29, p = 0.77)。TAVI + LAAO(13%)和TAVI + SMT(17%)的出血率相当,TAVI + LAAO组无非程序性出血,TAVI + SMT组有5例胃肠道出血,两组之间脑血管事件无显著差异(TAVI + LAAO为10%,TAVI + SMT为2.4%)。在方案分析中,主要终点的发生率在TAVI + LAAO和TAVI + SMT组之间具有可比较性(校正OR为0.55;95% CI: 0.18-1.56, p = 0.27),脑血管事件发生率分别为5.6%和2.4%,出血事件发生率分别为8.3%和17%。这项初步研究表明,在接受TAVI的高危房颤患者中,与单一TAVI手术相比,LAAO联合治疗和早期停止口服抗凝的策略总体上显示出相似的主要终点率(NCT03088098)。
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引用次数: 0
Considerations for Lifetime Management After TAVR or SAVR: When Bigger or Higher May Not Be Better TAVR或SAVR后终身管理的考虑:当更大或更高可能不是更好
IF 2.8 Q3 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2025-10-06 DOI: 10.1016/j.shj.2025.100734
Deven R. Rajagopal , Vinod H. Thourani MD , Pradeep K. Yadav MD
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引用次数: 0
Erratum to “72347 | Comparative Outcomes of Low-Dose Versus Standard-Dose Apixaban Following Left Atrial Appendage Occlusion: A Retrospective Propensity-Matched Cohort Study” [Structural Heart 9 (2025) 100542] “低剂量阿哌沙班与标准剂量阿哌沙班左心耳闭塞后的比较结果:一项回顾性倾向匹配队列研究”[结构心脏]9 (2025)100542]
IF 2.8 Q3 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2025-09-19 DOI: 10.1016/j.shj.2025.100711
Rakendu Jayasree Rajendran , Abdallah Hussein , Vinay Gadamidi , Elaf Khatib , Taha Wasim Syed , Eric Osgood , Kintur Sanghvi
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引用次数: 0
期刊
Structural Heart
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