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WATCHMAN Complications Revisited Using Ultra-High Resolution Photon-Counting Computed Tomography 使用超高分辨率光子计数计算机断层扫描重新审视WATCHMAN并发症
IF 2.8 Q3 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2025-10-30 DOI: 10.1016/j.shj.2025.100753
Alexander Diamant MD , Connor P. Murray MBBS , Joseph Hanna MBBS
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引用次数: 0
Mission M-Possible: Mitral Transcatheter Edge-to-Edge Repair in Mitral Annular Calcification Using the Crab-Walk Technique 任务m -可能:二尖瓣经导管边缘对边缘修复二尖瓣环钙化使用蟹步技术
IF 2.8 Q3 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2025-10-29 DOI: 10.1016/j.shj.2025.100736
John Abdelmalek MD , Muhammad Qudrat-Ullah MD , Ahmed Souka MD , Sibi Thomas DO , Ralph Matar MD , Lee Hafen MD , Karim Al-Azizi MD

Background

Mitral annular calcification (MAC) complicates transcatheter interventions for degenerative mitral regurgitation (DMR), particularly with small mitral valve orifice areas (MVOAs).

Case Summary

An 83-year-old woman with severe DMR, severe MAC, and MVOA of 3.8 cm2 presented post-heart failure hospitalization with declining function. High surgical risk and unfavorable transcatheter mitral valve replacement anatomy (neo-LVOT 0.30 cm2) limited options to transcatheter edge-to-edge repair (TEER). Using the Edwards PASCAL precision system and the “Crab-Walk” technique (independent leaflet clasp manipulation for MAC-related challenges), TEER reduced mitral regurgitation to mild (1+), with a 2 mmHg gradient at 3 months. The patient was weaned off oxygen and remains asymptomatic at 1 year.

Discussion

This first reported mitral TEER case in DMR with significant MAC and small MVOA highlights the “Crab-Walk” technique’s innovation.

Take-Home Messages

TEER with novel techniques is viable for DMR with MAC when transcatheter mitral valve replacement is prohibitive.
背景:二尖瓣环钙化(MAC)使经导管介入治疗退行性二尖瓣反流(DMR)复杂化,特别是二尖瓣口面积小(MVOAs)。一例83岁女性,重度DMR,重度MAC, MVOA 3.8 cm2,心力衰竭住院,功能下降。高手术风险和不利的经导管二尖瓣置换术解剖(新lvot 0.30 cm2)限制了经导管边缘到边缘修复(TEER)的选择。使用Edwards PASCAL精密系统和“蟹式行走”技术(针对mac相关挑战的独立小叶卡扣操作),TEER将二尖瓣反流降低至轻度(1+),3个月时梯度为2mmhg。患者停用氧气,1年后仍无症状。这是首次报道的二尖瓣TEER病例,伴有明显的MAC和较小的MVOA,突出了“螃蟹行走”技术的创新。当经导管二尖瓣置换术禁止时,采用新技术的Take-Home MessagesTEER对于MAC的DMR是可行的。
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引用次数: 0
Impact of Changes in Renal Function on Outcomes Following Mitral Transcatheter Edge-To-Edge Repair 二尖瓣边缘到边缘修复术后肾功能改变对预后的影响。
IF 2.8 Q3 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2025-10-29 DOI: 10.1016/j.shj.2025.100747
Parth N. Patel MD , Olivia L. Hulme MD , Marc Allard-Ratick MD , Jay Khambhati MD , Amanda Stebbins MPH , Andrzej S. Kosinski PhD , Sreekanth Vemulapalli MD , Sammy Elmariah MD, MPH

Background

Hemodynamic changes following mitral transcatheter edge-to-edge repair (mTEER) may impact estimated glomerular filtration rate (eGFR), but whether changes in eGFR following mTEER are associated with subsequent clinical outcomes is not known. The objective of the study was to investigate procedure-related changes in eGFR and clinical outcomes following mTEER.

Methods

We studied patients in the Transcatheter Valve Therapy registry undergoing mTEER between 2013 and 2022 with available baseline and discharge eGFR. Multivariable linear regression identified baseline characteristics associated with changes in eGFR following mTEER. Cox proportional hazards models examined the adjusted association between improved (≥10% increase in eGFR), unchanged, and worsened renal function (≥10% decrease in eGFR) and survival at 1 year.

Results

Among 48,472 patients undergoing mTEER, 15.7% experienced improved renal function and 13.7% had worsened renal function. Cardiogenic shock within 24 hours, age >80, Black race, diabetes, heart failure within 2 weeks, and female sex were strongly associated with worsened renal function after mTEER. Compared to the group with no change in renal function, improved renal function was associated with a decreased risk of 1-year mortality (adjusted hazard ratio: 0.77; 95% CI 0.69-0.86, p < 0.001), whereas worsened renal function was associated with an increased risk of death at 1 year (adjusted hazard ratio: 2.85; 95% CI 2.64-3.08, p < 0.001).

Conclusions

Approximately 30% of patients experience marked changes in renal function following mTEER.
A greater than 10% increase or decrease in eGFR is independently associated with differences in 1-year survival. Careful attention to patients at greatest risk for worsened renal function after mTEER is warranted.
背景:二尖瓣经导管边缘到边缘修复(mTEER)后的血流动力学变化可能影响估计的肾小球滤过率(eGFR),但mTEER后eGFR的变化是否与随后的临床结果相关尚不清楚。该研究的目的是调查mTEER术后eGFR的手术相关变化和临床结果。方法:我们研究了2013年至2022年间接受mTEER的经导管瓣膜治疗登记的患者,这些患者具有可用的基线和出院eGFR。多变量线性回归确定了与mTEER后eGFR变化相关的基线特征。Cox比例风险模型检验了1年生存率与肾功能改善(eGFR升高≥10%)、肾功能不变和肾功能恶化(eGFR降低≥10%)之间的相关性。结果:48472例接受mTEER治疗的患者中,15.7%的患者肾功能改善,13.7%的患者肾功能恶化。24小时内心源性休克、年龄80 ~ 80岁、黑人、糖尿病、2周内心力衰竭、女性与mTEER术后肾功能恶化密切相关。与肾功能无变化组相比,肾功能改善与1年死亡风险降低相关(校正风险比:0.77;95% CI: 0.69-0.86, p < 0.001),而肾功能恶化与1年死亡风险增加相关(校正风险比:2.85;95% CI: 2.64-3.08, p < 0.001)。结论:大约30%的患者在mTEER后出现明显的肾功能改变。大于10%的eGFR升高或降低与1年生存率的差异独立相关。对mTEER术后肾功能恶化风险最大的患者给予密切关注是必要的。
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引用次数: 0
The Impact of Prosthesis-Patient Mismatch on Bioprosthetic Valve Durability After Transcatheter Aortic Valve Replacement 经导管主动脉瓣置换术后假体-患者不匹配对生物假体瓣膜耐久性的影响
IF 2.8 Q3 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2025-10-27 DOI: 10.1016/j.shj.2025.100741
Revathy Sampath-Kumar MD, Erika Padilla BS, David Torres Barba MD, PhD, Niki Aramburo CVT, Ori Ben-Yehuda MD, Ehtisham Mahmud MD

Background

Prosthesis-patient mismatch (PPM) is associated with structural valve deterioration after surgical aortic valve replacement. Limited evidence exists regarding its impact on hemodynamic valve deterioration (HVD) and bioprosthetic valve failure (BVF) following transcatheter aortic valve replacement (TAVR).

Methods

Patients who underwent TAVR from 2013 to 2022 at UC San Diego Health with echocardiographic follow-up were retrospectively analyzed. PPM, determined by measured indexed effective orifice area, and outcomes of moderate or severe HVD and BVF were defined per Valve Academic Research Consortium 3 guidelines. Fine and Gray regression, with all-cause death as a competing risk, was used to compare the cumulative incidence of outcomes in patients with and without PPM.

Results

A total of 555 patients (38.7% female, median age 81 years, median Society of Thoracic Surgeons risk score 4.2%, 96.8% balloon-expandable valves) were included. PPM occurred in 66 (11.9%) patients and was associated with higher initial post-implant mean gradient (15 mmHg IQR: 10-22 vs. 11 mmHg IQR: 8-15; p < 0001) and peak velocity (2.6 m/s IQR: 2.2-3.2 vs. 2.3 m/s IQR: 1.9-2.6; p < 0.001). Valve-in-valve TAVR (adjusted odds ratio: 7.84; 95% CI: 3.37-18.20; p < 0.001) and valve diameter ≤23 mm (adjusted odds ratio: 2.39; 95% CI: 1.12-5.10; p = 0.024) were independent predictors of PPM. The adjusted cumulative incidence of moderate or severe HVD (adjusted hazard ratio: 2.10; 95% CI: 1.02-4.30; p = 0.04) and BVF (adjusted hazard ratio: 4.32; 95% CI: 1.81-10.31; p = 0.001) was higher with PPM. Aortic valve reintervention was higher with PPM (4.5 vs. 0.6%; p = 0.03).

Conclusions

In this single-center cohort, PPM was associated with an over two-fold increased risk of moderate or severe HVD and an over four-fold increased risk of BVF following TAVR, emphasizing the importance of pre-implant prevention.
背景:主动脉瓣置换术后假体-患者不匹配(PPM)与瓣膜结构恶化有关。关于其对经导管主动脉瓣置换术(TAVR)后血流动力学瓣膜恶化(HVD)和生物假体瓣膜衰竭(BVF)的影响的证据有限。方法回顾性分析2013年至2022年在加州大学圣地亚哥分校健康中心接受TAVR的患者,并进行超声心动图随访。PPM由测量的指数有效孔口面积决定,中度或重度HVD和BVF的结果根据瓣膜学术研究联盟3指南进行定义。Fine和Gray回归,将全因死亡作为竞争风险,用于比较有和无PPM患者的累积结局发生率。结果共纳入555例患者,其中女性38.7%,中位年龄81岁,胸外科学会中位风险评分4.2%,球囊可膨胀瓣膜96.8%。66例(11.9%)患者发生了PPM,并且与较高的初始种植后平均梯度(15 mmHg IQR: 10-22 vs 11 mmHg IQR: 8-15; p < 0001)和峰值流速(2.6 m/s IQR: 2.2-3.2 vs 2.3 m/s IQR: 1.9-2.6; p < 0.001)相关。阀中TAVR(校正优势比:7.84;95% CI: 3.37-18.20; p < 0.001)和阀径≤23 mm(校正优势比:2.39;95% CI: 1.12-5.10; p = 0.024)是PPM的独立预测因子。中度或重度HVD(校正风险比:2.10;95% CI: 1.02-4.30; p = 0.04)和BVF(校正风险比:4.32;95% CI: 1.81-10.31; p = 0.001)的校正累积发病率随PPM升高。主动脉瓣再介入治疗在PPM组较高(4.5 vs 0.6%; p = 0.03)。结论:在这个单中心队列中,PPM与TAVR后中度或重度HVD风险增加2倍以上,BVF风险增加4倍以上相关,强调了植入前预防的重要性。
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引用次数: 0
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。
{"title":"Impact of Central vs. Noncentral Predominant Jet Location on Clinical Outcomes: Results From the EXPANDed Studies","authors":"Jason H. Rogers MD ,&nbsp;Matthew J. Price MD ,&nbsp;Gagan D. Singh MD ,&nbsp;Paul Mahoney MD ,&nbsp;Mathew Williams MD ,&nbsp;Paolo Denti MD ,&nbsp;Anita Asgar MD ,&nbsp;Janani Aiyer MS ,&nbsp;Rong Huang MS ,&nbsp;Jose Luis Zamorano MD ,&nbsp;Federico M. Asch MD ,&nbsp;Francesco Maisano MD ,&nbsp;Saibal Kar MD ,&nbsp;Ralph Stephan von Bardeleben MD ,&nbsp;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}
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}
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Structural Heart
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