Pub Date : 2025-10-25DOI: 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。
{"title":"Impact of Central vs. Noncentral Predominant Jet Location on Clinical Outcomes: Results From the EXPANDed Studies","authors":"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","doi":"10.1016/j.shj.2025.100743","DOIUrl":"10.1016/j.shj.2025.100743","url":null,"abstract":"<div><h3>Background</h3><div>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.</div></div><div><h3>Methods</h3><div>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.</div></div><div><h3>Results</h3><div>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%; <em>p</em> = 0.15), with low 30-day major adverse event rates in both (A2P2: 4.2%, non-A2P2: 7.4%; <em>p</em> = 0.16). MR ≤ 1+ was achieved in both groups at 1 year (A2P2: 91%, non-A2P2: 84%, <em>p</em> = 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%; <em>p</em> = 0.47).</div></div><div><h3>Conclusions</h3><div>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.</div></div>","PeriodicalId":36053,"journal":{"name":"Structural Heart","volume":"9 12","pages":"Article 100743"},"PeriodicalIF":2.8,"publicationDate":"2025-10-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145570581","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}
Pub Date : 2025-10-24DOI: 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。
{"title":"Transcatheter Versus Surgical Aortic Valve Replacement in Women of Childbearing Age in the United States","authors":"Mahmoud Ismayl MBBS , Hasaan Ahmed MD , Andrew M. Goldsweig MD, MS , Mayra Guerrero MD","doi":"10.1016/j.shj.2025.100746","DOIUrl":"10.1016/j.shj.2025.100746","url":null,"abstract":"<div><h3>Background</h3><div>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.</div></div><div><h3>Methods</h3><div>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.</div></div><div><h3>Results</h3><div>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 (p<sub>trend</sub><0.001). Compared with SAVR, TAVR was associated with lower in-hospital mortality (<1.4 vs. 3.5%, <em>p</em> = 0.03), acute kidney injury (9.0 vs. 16.8%, <em>p</em> = 0.002), and need for blood transfusion (7.1 vs. 19.1%, <em>p</em> < 0.001), but higher heart block (23.5 vs. 9.7%, <em>p</em> < 0.001) and vascular complications (5.0 vs. 2.1%, <em>p</em> = 0.03). Length of stay was shorter (2 vs. 7 days, <em>p</em> < 0.001) and nonhome discharges were lower (16.2 vs. 56.7%, <em>p</em> < 0.001) with TAVR compared with SAVR. Ninety-day all-cause readmissions were similar between TAVR and SAVR (12.6 vs. 13.3%, <em>p</em> = 0.78).</div></div><div><h3>Conclusions</h3><div>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.</div></div>","PeriodicalId":36053,"journal":{"name":"Structural Heart","volume":"9 12","pages":"Article 100746"},"PeriodicalIF":2.8,"publicationDate":"2025-10-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145570582","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}
Pub Date : 2025-10-22DOI: 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
{"title":"Transcatheter Aortic Valve Implantation in Latin America: Lessons From Chile’s Limited Access","authors":"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","doi":"10.1016/j.shj.2025.100745","DOIUrl":"10.1016/j.shj.2025.100745","url":null,"abstract":"","PeriodicalId":36053,"journal":{"name":"Structural Heart","volume":"10 1","pages":"Article 100745"},"PeriodicalIF":2.8,"publicationDate":"2025-10-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145682104","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}
Pub Date : 2025-10-13DOI: 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.
{"title":"Quantification of Alpha-Gal Expression in Commercial BioProsthetic Heart Valves and Its Potential Mitigation","authors":"Andrea Colli MD , Peter Zilla MD , Antonio Maria Calafiore MD , Massimo Padalino MD , Filippo Naso MLT, BSc , Isaac George MD","doi":"10.1016/j.shj.2025.100739","DOIUrl":"10.1016/j.shj.2025.100739","url":null,"abstract":"<div><h3>Background and Aims</h3><div>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.</div></div><div><h3>Methods</h3><div>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.</div></div><div><h3>Results</h3><div>The average count of the αGal epitope in original pericardial valve models was 4.18 ± 0.72 × 10<sup>11</sup>/10 mg of tissue, whereas porcine valve-derived prostheses exhibited a higher mean value of 8.51 ± 2.17 × 10<sup>11</sup>/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.</div></div><div><h3>Conclusion</h3><div>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.</div></div>","PeriodicalId":36053,"journal":{"name":"Structural Heart","volume":"10 3","pages":"Article 100739"},"PeriodicalIF":2.8,"publicationDate":"2025-10-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146090676","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}
Pub Date : 2025-10-12DOI: 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.
{"title":"Long-Term Outcomes of Indirect Annuloplasty for Functional Mitral Regurgitation: Interim Results From the CINCH Registry","authors":"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","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}
Pub Date : 2025-10-08DOI: 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。
{"title":"Managing Hostile Aortic Anatomies Using an Extended-Length Introducer Sheath During Transfemoral Transcatheter Aortic Valve Replacement: Rationale and Clinical Outcomes","authors":"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","doi":"10.1016/j.shj.2025.100737","DOIUrl":"10.1016/j.shj.2025.100737","url":null,"abstract":"<div><h3>Background</h3><div>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.</div></div><div><h3>Methods</h3><div>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.</div></div><div><h3>Results</h3><div>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.</div></div><div><h3>Conclusions</h3><div>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.</div></div>","PeriodicalId":36053,"journal":{"name":"Structural Heart","volume":"9 12","pages":"Article 100737"},"PeriodicalIF":2.8,"publicationDate":"2025-10-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145521268","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}
Pub Date : 2025-10-08DOI: 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).
{"title":"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","authors":"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","doi":"10.1016/j.shj.2025.100735","DOIUrl":"10.1016/j.shj.2025.100735","url":null,"abstract":"<div><h3>Background</h3><div>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.</div></div><div><h3>Methods</h3><div>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.</div></div><div><h3>Results</h3><div>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, <em>p</em> = 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, <em>p</em> = 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.</div></div><div><h3>Conclusions</h3><div>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).</div></div>","PeriodicalId":36053,"journal":{"name":"Structural Heart","volume":"9 12","pages":"Article 100735"},"PeriodicalIF":2.8,"publicationDate":"2025-10-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145521267","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}
Pub Date : 2025-10-06DOI: 10.1016/j.shj.2025.100734
Deven R. Rajagopal , Vinod H. Thourani MD , Pradeep K. Yadav MD
{"title":"Considerations for Lifetime Management After TAVR or SAVR: When Bigger or Higher May Not Be Better","authors":"Deven R. Rajagopal , Vinod H. Thourani MD , Pradeep K. Yadav MD","doi":"10.1016/j.shj.2025.100734","DOIUrl":"10.1016/j.shj.2025.100734","url":null,"abstract":"","PeriodicalId":36053,"journal":{"name":"Structural Heart","volume":"9 12","pages":"Article 100734"},"PeriodicalIF":2.8,"publicationDate":"2025-10-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145521266","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}