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Foldax LifePolymer and A Novel Polymeric Heart Valve: Pathway to Clinical Evaluation. Foldax LifePolymer和一种新型高分子心脏瓣膜:通往临床评估的途径。
IF 1.6 Q2 SURGERY Pub Date : 2025-09-01 Epub Date: 2025-10-03 DOI: 10.1177/15569845251375566
Andy C Kiser, Isaac George, Brent D Wilson, Brian Whisenant, Steven J Yakubov, Martin B Leon

Objective: An optimal valve replacement prosthesis demands durable leaflet technology, superior hemodynamic performance, and ease of use. Preclinical evaluation of polymer leaflets has historically demonstrated mechanical failure related to biodegradation. We present the preclinical evaluation of the novel TRIA™ polymer valve (Foldax, Salt Lake City, UT, USA) and a case report of TRIA mitral valve replacement.

Methods: A uniquely formulated, biostable, and biocompatible polymer (LifePolymer™ [LP], Foldax) has been designed to meet the functional demands of cardiac hemodynamics. Preclinical in vitro evaluation included biocompatibility testing, thrombogenicity testing, and toxicologic assessment followed by evaluation in the arteriovenous shunt of nonhuman primates and in the aortic position in sheep. Clinical evaluation of early human aortic and mitral implantation included computed tomography imaging and echocardiographic examination.

Results: In vitro studies of LP demonstrated no evidence of toxicity or tissue injury, no cytological injury in cell culture, and no intracutaneous sensitization. LP proved to be nonhemolytic by direct and extract methods, and complement activation was insignificant. Genotoxicity analysis proved LP to be nonmutagenic. All standard toxicologic assessments were within the margin of safety. Biostability was confirmed without polymer degradation or excessive comparative thrombogenicity. Ovine 6-month aortic valve explantation showed no leaflet calcification and minimal fibrinous depositions. An early human case example shows no evidence of leaflet thrombus formation at 6 months and a mean mitral gradient of 3 mm Hg at 12 months.

Conclusions: LP has met the requirements for a prosthetic polymer human heart valve. The surgical TRIA Mitral Valve has demonstrated promising early human clinical success, potentially facilitating a lifetime valve replacement strategy.

目的:理想的瓣膜置换术需要持久的瓣叶技术、优异的血流动力学性能和易于使用。聚合物小叶的临床前评估历来显示与生物降解有关的机械失效。我们介绍了新型TRIA™聚合物瓣膜(Foldax, Salt Lake City, UT, USA)的临床前评估和TRIA二尖瓣置换术的病例报告。方法:一种独特配方的、生物稳定的、生物相容的聚合物(LifePolymer™[LP], Foldax)被设计用于满足心脏血流动力学的功能需求。临床前体外评估包括生物相容性测试、血栓形成性测试和毒理学评估,随后在非人灵长类动物的动静脉分流和绵羊的主动脉位置进行评估。早期人主动脉瓣和二尖瓣植入术的临床评价包括计算机断层成像和超声心动图检查。结果:体外研究表明,LP没有毒性或组织损伤的证据,在细胞培养中没有细胞学损伤,也没有皮内致敏。直接法和提取法均证实LP无溶血作用,补体活化作用不显著。遗传毒性分析证明LP无致突变性。所有标准毒理学评估均在安全范围内。生物稳定性证实无聚合物降解或过多的相对血栓形成性。6个月大的绵羊主动脉瓣外植未见小叶钙化和少量纤维沉积。一个早期的人类病例在6个月时没有小叶血栓形成的证据,在12个月时平均二尖瓣梯度为3mmhg。结论:LP符合高分子人造心脏瓣膜的要求。外科手术的TRIA二尖瓣已经显示出有希望的早期人类临床成功,潜在地促进终身瓣膜置换策略。
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引用次数: 0
Mitral Valve Repair and RIMA Bypass to RCA via Right Minithoracotomy Approach: When Less Is More. 经右小开胸入路二尖瓣修复及RIMA旁路至RCA:当少即是多。
IF 1.6 Q2 SURGERY Pub Date : 2025-09-01 Epub Date: 2025-08-16 DOI: 10.1177/15569845251364256
Ahmed Ghazy, Edoardo Zancanaro, Daniela Endres, Hendrik Treede
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引用次数: 0
In Vivo Feasibility and Growth of Atrioventricular Partial Heart Transplantation in a Porcine Model. 猪房室部分心脏移植的体内可行性及生长情况。
IF 1.6 Q2 SURGERY Pub Date : 2025-09-01 Epub Date: 2025-10-13 DOI: 10.1177/15569845251384564
Seth E M Wolf, John A Kucera, Smith M Ngeve, Berk Aykut, Hiba Z Ghandour, Stephen G Miller, Joseph W Turek, Douglas M Overbey

Objective: Pediatric mitral valve replacement remains a significant challenge due to the lack of growth-capable prostheses, often necessitating multiple reoperations. Partial heart transplantation (PHT) has shown promise in the semilunar position but has not been studied in the atrioventricular (AV) position. This study evaluates the feasibility and growth potential of AV PHT in an in vivo porcine model.

Methods: Three Yorkshire piglets underwent AV PHT, with the donor mitral valve implanted into the tricuspid position due to animal intraoperative tolerance limitations. The first 2 animals were used to refine surgical technique. The third piglet was designated for 2-month survival with serial echocardiographic monitoring. Donor valves were procured on the day of surgery to minimize ischemic time. Postoperative immunosuppression included tacrolimus, mycophenolate mofetil, and methylprednisolone.

Results: The survival animal tolerated the procedure well and remained clinically stable. Echocardiography demonstrated significant growth of the PHT mitral annulus from 2.0 cm to 4.3 cm, compared with 2.4 cm to 3.0 cm in the native annulus. The length of the PHT leaflet increased from 1.3 cm to 2.4 cm, whereas the length of the native leaflet increased from 1.1 cm to 1.9 cm. Nonprogressive moderate regurgitation was observed without stenosis. Gross examination confirmed excellent tissue integration without calcification or fibrosis.

Conclusions: This study demonstrates the in vivo feasibility and growth potential of AV PHT, representing a promising step toward growth-capable valve replacement for pediatric patients with irreparable mitral valve disease.

目的:由于缺乏能够生长的假体,儿童二尖瓣置换术仍然是一个重大挑战,经常需要多次再手术。部分心脏移植(PHT)在半月体位显示出前景,但在房室(AV)体位尚未研究。本研究在猪体内模型中评估了AV PHT的可行性和生长潜力。方法:3头约克郡仔猪行AV PHT,由于动物术中耐受能力的限制,供体二尖瓣植入三尖瓣位置。前2只动物用于改进手术技术。第三头仔猪在连续超声心动图监测下存活2个月。供体瓣膜在手术当天获得,以尽量减少缺血时间。术后免疫抑制包括他克莫司、霉酚酸酯和甲基强的松龙。结果:存活动物对手术耐受良好,临床表现稳定。超声心动图显示PHT二尖瓣环从2.0 cm增加到4.3 cm,而原生二尖瓣环仅为2.4 cm到3.0 cm。PHT小叶的长度从1.3 cm增加到2.4 cm,而原生小叶的长度从1.1 cm增加到1.9 cm。无进展性中度反流,无狭窄。大体检查证实组织整合良好,无钙化或纤维化。结论:本研究证明了AV PHT在体内的可行性和生长潜力,代表了为无法修复的二尖瓣疾病的儿童患者提供生长能力瓣膜置换术的有希望的一步。
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引用次数: 0
Simultaneous Transcatheter Double Valve Replacement: Aortic Valve-in-Valve Replacement and Mitral Valve Replacement With the Tendyne Valve. 同时经导管双瓣置换术:主动脉瓣内置换术和二尖瓣置换术。
IF 1.6 Q2 SURGERY Pub Date : 2025-09-01 Epub Date: 2025-09-16 DOI: 10.1177/15569845251375975
Ivo Gasparovic, Panagiotis Artemiou, Stefan Durdik, Erika Drangova, Marian Vidiscak, Michal Hulman
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引用次数: 0
Endoscopic Mitral Valve Repair on a Pectus Excavatum Patient. 漏斗胸患者的内窥镜二尖瓣修复术。
IF 1.6 Q2 SURGERY Pub Date : 2025-09-01 Epub Date: 2025-09-04 DOI: 10.1177/15569845251365731
Henri Bartolozzi, Katerina Katramadou, Nikos Tsotsolis, Antonios Pitsis
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引用次数: 0
First Reported Series of Endoscopic Transposition of the Anterior Mitral Leaflet as a Patch for Posterior Annular MAC Debridement. 首次报道的内镜下二尖瓣前小叶转位作为后环MAC清创的补片。
IF 1.6 Q2 SURGERY Pub Date : 2025-09-01 Epub Date: 2025-08-21 DOI: 10.1177/15569845251364312
Mario Castillo-Sang, Matias Rios, Tom Wilkinson, Mickey Ising, George Christensen
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引用次数: 0
Innovations in Heart Transplantation: Partial Heart Transplantation and Xenotransplantation. 心脏移植的创新:部分心脏移植和异种移植。
IF 1.6 Q2 SURGERY Pub Date : 2025-09-01 Epub Date: 2025-10-07 DOI: 10.1177/15569845251375442
Zachary T Silvano, Vincent S Alexander, Sreeja Choppara, Andrew D Vogel, Herra Javed, John Treffalls, T Konrad Rajab

Despite efforts to improve donor heart allocation policies, geographic disparities, logistical challenges and patient criteria limit organ availability. However, recent surgical innovations offer potential solutions. These include partial heart transplantation and xenotransplantation. Partial heart transplantation is a new procedure with the potential to address several clinical challenges in treating congenital heart defects. Cardiac xenotransplantation involves the transplantation of genetically modified porcine hearts into humans, offering a potential solution to the shortage of donor organs. Although immunologic barriers and ethical concerns remain, ongoing research aims to mitigate the risks and optimize outcomes, providing hope for patients in need. These innovative surgical approaches offer promising avenues for addressing the critical shortage of donor hearts and with ongoing research, may hold the potential to revolutionize heart transplantation, and improve outcomes for patients facing terminal heart failure.

尽管努力改善供体心脏分配政策,但地域差异、后勤挑战和患者标准限制了器官的可用性。然而,最近的外科创新提供了潜在的解决方案。这包括部分心脏移植和异种心脏移植。部分心脏移植是一项新的手术,有可能解决治疗先天性心脏缺陷的几个临床挑战。心脏异种移植涉及将转基因猪心脏移植到人类身上,为供体器官短缺提供了一个潜在的解决方案。尽管免疫障碍和伦理问题仍然存在,但正在进行的研究旨在减轻风险并优化结果,为有需要的患者提供希望。这些创新的手术方法为解决供体心脏的严重短缺提供了有希望的途径,并且正在进行的研究可能具有彻底改变心脏移植的潜力,并改善终末期心力衰竭患者的预后。
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引用次数: 0
Outcomes of 3-Dimensional Total Endoscopic Surgery for Partial Atrioventricular Septal Defect in Children: A Single-Center Experience in Vietnam. 三维全内窥镜手术治疗儿童部分房室间隔缺损的结果:越南的单中心经验。
IF 1.6 Q2 SURGERY Pub Date : 2025-09-01 Epub Date: 2025-06-30 DOI: 10.1177/15569845251351945
Tien Anh Do, Tran-Thuy Nguyen, Minh Ngoc Le, Thanh Ngoc Le

Objective: To assess the midterm outcomes and feasibility of using 3-dimensional total endoscopic surgery (3D TES) for complete correction of partial atrioventricular septal defect (PAVSD) in children.

Methods: A descriptive study from January 2018 to June 2024 involved 20 patients with PAVSD who underwent surgical repair using 3D TES. The average patient age and average weight were 9.1 (range: 4 to 15) years and 25.02 kg, respectively. Mitral valve regurgitation was classified as mild in 2 patients, moderate in 12, and severe in 6, whereas tricuspid valve regurgitation was mild in 13 patients and moderate in 7.

Results: Peripheral circulation was established in all patients. Cardiopulmonary bypass and aortic cross-clamp times were 86.2 min and 142.2 min, respectively. The mechanical ventilation time averaged 4.9 h. Postoperative echocardiography included complete closure of the atrial septal defect, with mild mitral valve regurgitation in 16 patients and no regurgitation in 4. Tricuspid valve regurgitation was mild in 11 patients, and 9 patients had no regurgitation. During an average postoperative follow-up period of 3.35 years, there were no mortalities or cases requiring reoperation.

Conclusions: The 3D TES demonstrates feasibility, safety, and efficacy in treating PAVSD in children, with apparent aesthetic advantages.

目的:评价三维全内镜手术(3D TES)完全矫正儿童部分房室间隔缺损(PAVSD)的中期疗效和可行性。方法:2018年1月至2024年6月,一项描述性研究纳入了20例采用3D TES手术修复的PAVSD患者。患者平均年龄为9.1岁,平均体重为25.02 kg(4 ~ 15岁)。二尖瓣反流2例为轻度,12例为中度,6例为重度,三尖瓣反流13例为轻度,7例为中度。结果:所有患者外周血循环正常。体外循环和主动脉交叉夹持时间分别为86.2 min和142.2 min。机械通气时间平均4.9 h。术后超声心动图显示房间隔缺损完全闭合,16例出现轻度二尖瓣返流,4例无返流。11例轻度三尖瓣反流,9例无反流。术后平均随访3.35年,无死亡病例,无再次手术病例。结论:3D TES治疗儿童PAVSD具有可行性、安全性和有效性,且具有明显的美学优势。
{"title":"Outcomes of 3-Dimensional Total Endoscopic Surgery for Partial Atrioventricular Septal Defect in Children: A Single-Center Experience in Vietnam.","authors":"Tien Anh Do, Tran-Thuy Nguyen, Minh Ngoc Le, Thanh Ngoc Le","doi":"10.1177/15569845251351945","DOIUrl":"10.1177/15569845251351945","url":null,"abstract":"<p><strong>Objective: </strong>To assess the midterm outcomes and feasibility of using 3-dimensional total endoscopic surgery (3D TES) for complete correction of partial atrioventricular septal defect (PAVSD) in children.</p><p><strong>Methods: </strong>A descriptive study from January 2018 to June 2024 involved 20 patients with PAVSD who underwent surgical repair using 3D TES. The average patient age and average weight were 9.1 (range: 4 to 15) years and 25.02 kg, respectively. Mitral valve regurgitation was classified as mild in 2 patients, moderate in 12, and severe in 6, whereas tricuspid valve regurgitation was mild in 13 patients and moderate in 7.</p><p><strong>Results: </strong>Peripheral circulation was established in all patients. Cardiopulmonary bypass and aortic cross-clamp times were 86.2 min and 142.2 min, respectively. The mechanical ventilation time averaged 4.9 h. Postoperative echocardiography included complete closure of the atrial septal defect, with mild mitral valve regurgitation in 16 patients and no regurgitation in 4. Tricuspid valve regurgitation was mild in 11 patients, and 9 patients had no regurgitation. During an average postoperative follow-up period of 3.35 years, there were no mortalities or cases requiring reoperation.</p><p><strong>Conclusions: </strong>The 3D TES demonstrates feasibility, safety, and efficacy in treating PAVSD in children, with apparent aesthetic advantages.</p>","PeriodicalId":13574,"journal":{"name":"Innovations: Technology and Techniques in Cardiothoracic and Vascular Surgery","volume":" ","pages":"472-476"},"PeriodicalIF":1.6,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12575815/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144527789","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Shaping the Future of Partial Heart Transplantation: Innovations and Emerging Applications. 塑造部分心脏移植的未来:创新和新兴应用。
IF 1.6 Q2 SURGERY Pub Date : 2025-09-01 Epub Date: 2025-10-03 DOI: 10.1177/15569845251375996
Seth E M Wolf, John A Kucera, Michael Mensah-Mamfo, John K Cook, Danielle R Pitchon, Lindsey M Reynolds, Akosua D Odei, Richard E Overman, Pranava Sinha, Yves d'Udekem, Joseph W Turek, Douglas M Overbey
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引用次数: 0
Beating Heart Versus Arrested Heart for Isolated Tricuspid Valve Surgery: A Kaplan-Meier-Derived Meta-Analysis. 孤立三尖瓣手术中心脏跳动与心脏骤停:kaplan - meier衍生meta分析。
IF 1.6 Q2 SURGERY Pub Date : 2025-09-01 Epub Date: 2025-09-17 DOI: 10.1177/15569845251375959
Massimo Baudo, Serge Sicouri, Yoshiyuki Yamashita, Dimitrios Magouliotis, Francesco Cabrucci, Basel Ramlawi

Objective: The aim of the current study was to analyze the clinical and surgical outcomes of patients undergoing isolated tricuspid valve surgery (ITVS) from the available literature. It currently remains uncertain whether arrested heart (AH) surgery has superior postoperative outcomes over beating heart (BH) for ITVS.

Methods: A systematic review and meta-analysis were conducted by searching PubMed, ScienceDirect, Scopus, DOAJ, SciELO, and Cochrane databases from 2000 until November 2024. The protocol was registered with the International Prospective Register of Systematic Reviews under the PROSPERO registration number CRD42024622618.

Results: A total of 22 studies met the inclusion criteria. These studies were published between 2012 and 2023 and included a combined total of 1,627 patients, with 1,053 in the BH group and 574 in the AH group. The present analysis showed that patients undergoing BH surgery were generally more comorbid and more frequently underwent minimally invasive procedures as compared with patients undergoing AH surgery. The BH and AH groups reported no significant differences in postoperative outcomes. At follow-up, BH was associated with higher recurrent >2+ tricuspid regurgitation rates (P = 0.048), but this did not affect late survival (hazard ratio [HR] = 0.90, 95% confidence interval [CI]: 0.68 to 1.19, P = 0.457) or reintervention for TV (HR = 1.18, 95% CI: 0.61 to 2.29, P = 0.622) rates.

Conclusions: A consensus between BH and AH for ITVS is still lacking. However, BH ITVS procedures appear to be the preferred surgeon choice for higher-risk patients. At follow-up, the BH group showed higher rates of recurrent tricuspid regurgitation >2+, without affecting late survival or rates of TV reintervention.

目的:本研究的目的是从现有文献中分析孤立三尖瓣手术(ITVS)患者的临床和手术结果。目前尚不确定是否停搏心脏(AH)手术比搏动心脏(BH)手术有更好的术后效果。方法:检索2000年至2024年11月PubMed、ScienceDirect、Scopus、DOAJ、SciELO和Cochrane数据库,进行系统评价和meta分析。该方案已在国际前瞻性系统评价注册中心注册,注册号为PROSPERO CRD42024622618。结果:共有22项研究符合纳入标准。这些研究发表于2012年至2023年,共纳入1627例患者,其中BH组1053例,AH组574例。目前的分析表明,与接受AH手术的患者相比,接受BH手术的患者通常有更多的合并症,并且更频繁地接受微创手术。BH组和AH组术后结果无显著差异。在随访中,BH与较高的复发性bbb2 +三尖瓣反流率相关(P = 0.048),但这并不影响晚期生存率(风险比[HR] = 0.90, 95%可信区间[CI]: 0.68至1.19,P = 0.457)或TV再干预率(HR = 1.18, 95% CI: 0.61至2.29,P = 0.622)。结论:对于ITVS的BH和AH仍缺乏共识。然而,BH ITVS手术似乎是高风险患者的首选外科医生选择。在随访中,BH组显示出更高的三尖瓣返流率,但不影响晚期生存率或TV再干预率。
{"title":"Beating Heart Versus Arrested Heart for Isolated Tricuspid Valve Surgery: A Kaplan-Meier-Derived Meta-Analysis.","authors":"Massimo Baudo, Serge Sicouri, Yoshiyuki Yamashita, Dimitrios Magouliotis, Francesco Cabrucci, Basel Ramlawi","doi":"10.1177/15569845251375959","DOIUrl":"10.1177/15569845251375959","url":null,"abstract":"<p><strong>Objective: </strong>The aim of the current study was to analyze the clinical and surgical outcomes of patients undergoing isolated tricuspid valve surgery (ITVS) from the available literature. It currently remains uncertain whether arrested heart (AH) surgery has superior postoperative outcomes over beating heart (BH) for ITVS.</p><p><strong>Methods: </strong>A systematic review and meta-analysis were conducted by searching PubMed, ScienceDirect, Scopus, DOAJ, SciELO, and Cochrane databases from 2000 until November 2024. The protocol was registered with the International Prospective Register of Systematic Reviews under the PROSPERO registration number CRD42024622618.</p><p><strong>Results: </strong>A total of 22 studies met the inclusion criteria. These studies were published between 2012 and 2023 and included a combined total of 1,627 patients, with 1,053 in the BH group and 574 in the AH group. The present analysis showed that patients undergoing BH surgery were generally more comorbid and more frequently underwent minimally invasive procedures as compared with patients undergoing AH surgery. The BH and AH groups reported no significant differences in postoperative outcomes. At follow-up, BH was associated with higher recurrent >2+ tricuspid regurgitation rates (<i>P</i> = 0.048), but this did not affect late survival (hazard ratio [HR] = 0.90, 95% confidence interval [CI]: 0.68 to 1.19, <i>P</i> = 0.457) or reintervention for TV (HR = 1.18, 95% CI: 0.61 to 2.29, <i>P</i> = 0.622) rates.</p><p><strong>Conclusions: </strong>A consensus between BH and AH for ITVS is still lacking. However, BH ITVS procedures appear to be the preferred surgeon choice for higher-risk patients. At follow-up, the BH group showed higher rates of recurrent tricuspid regurgitation >2+, without affecting late survival or rates of TV reintervention.</p>","PeriodicalId":13574,"journal":{"name":"Innovations: Technology and Techniques in Cardiothoracic and Vascular Surgery","volume":" ","pages":"442-451"},"PeriodicalIF":1.6,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145080585","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
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Innovations: Technology and Techniques in Cardiothoracic and Vascular Surgery
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