Bioprosthesis

生物假体
  • 文章类型: Journal Article
    目的:研究OmniflowII型假体在预防外周动脉疾病患者VGI中的作用,并报告短期和中期移植物相关发病率。
    方法:患者在2019年10月至2023年3月期间纳入前瞻性登记。主要终点是报告感染相关问题,手术相关的伤口问题和短期和中期移植物相关的发病率。次要终点是报告旁路通畅率和肢体抢救率。
    结果:125例患者共植入了146枚OmniflowII移植物。67例患者(45.9%)接受了股骨插入移植物,77例患者(52.7%)接受了同侧旁路手术(股pop/股骨干)。41例患者(28.1%)接受了小腿搭桥手术。76例患者(52.1%)曾在腹股沟进行过血管手术。平均随访时间为352天(范围0-1108天)。3.4%的患者遭受仅限于真皮的伤口感染,而8.2%的患者则涉及皮下组织。发生了五次早期VGI(3.4%)和一次晚期VGI(0.7%)。与膝盖下方的旁路相比,膝盖上方旁路的一年主要通畅率显着更好(74.5%±0.131对54%±0.126(p=0.049))。当膝盖以下搭桥手术与小腿搭桥手术相比时,这种差异没有显着差异(54%±0.126对23.8%±0.080(p=0.098))。
    结论:OmniflowII型假体在预防性环境中的性能受到远端吻合的解剖位置的高度影响。未观察到对术后伤口问题发生率的影响。高危人群中OmniflowIIVGI的发生率与其他假体移植物的报告结果相似。
    OBJECTIVE: To investigate the role of the Omniflow II prosthesis in the prevention of VGI in patients with peripheral arterial disease and to report on short-and mid-term graft-related morbidity.
    METHODS: Patients were included in prospective registry between October 2019 and March 2023. The primary endpoint was to report infection related problems, operation related wound problems and short- and mid-term graft-related morbidity. Secondary endpoint was to report the bypass patency rates and limb salvage rates.
    RESULTS: A total of 146 Omniflow II grafts were implanted in 125 patients. Sixty-seven patients (45.9%) received a femoral interposition graft and 77 patients (52.7%) underwent ipsilateral bypass surgery (femoropopliteal/femorocrural). Forty-one patients (28.1%) underwent crural bypass surgery. Seventy-six patients (52.1%) had previous vascular operation in the groin. Mean Follow-up time was 352 days (range 0-1108 days). 3.4% of the patients suffered a wound infection limited to the dermis and in 8.2% the subcutaneous tissue was involved. Five early VGI (3.4%) and one late VGI (0.7%) occurred. One year primary patency rate of above the knee bypass was significantly better compared to the bypass below the knee (74.5% ± 0.131 versus 54% ± 0.126 (p=0.049)). This difference was not significantly different when below the knee bypass surgery was compared to crural bypass surgery (54% ± 0.126 versus 23.8% ± 0.080 (p=0.098)).
    CONCLUSIONS: The performance of the Omniflow II prosthesis in the preventive setting is highly influenced by the anatomic location of the distal anastomosis. No influence on the incidence of postoperative wound problems could be observed. The rate of Omniflow II VGI in a high risk population is similar to reported outcomes in other prosthetic grafts.
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  • 文章类型: Editorial
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  • 文章类型: Case Reports
    心脏内血栓形成是体外膜氧合(ECMO)机械循环支持的潜在破坏性并发症。我们在这里介绍一名患者,该患者在ECMO伴主动脉瓣关闭不全的情况下遭受了新鲜的二尖瓣假体和左心房的完全血栓形成,并接受了重复的瓣膜置换和血栓切除术。据我们所知,她是报道文献中唯一一个在这种并发症中幸存下来的患者.
    Intra-cardiac thrombosis is a potentially devastating complication of extracorporeal membrane oxygenation (ECMO) mechanical circulatory support. We present here a patient who suffered complete thrombosis of a fresh mitral prosthesis and left atrium in the setting of ECMO with aortic insufficiency who was treated with repeat valve replacement and thrombectomy. To our knowledge, she is the only patient in the reported literature to have survived this complication.
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  • 文章类型: Journal Article
    背景:我们旨在总结现有的关于使用生物瓣膜假体进行主动脉瓣置换术(SAVR)后的抗血栓药物治疗的知识。
    方法:我们进行了一项荟萃分析,这些研究报告了使用抗血栓药物预防SAVR后血栓栓塞事件的结果,并记录了术后12个月的结果。由于没有确定随机对照试验,纳入观察性研究。手术后0-12个月和3-12个月分别进行分析。随机效应模型用于计算合并结局事件率和95%置信区间(CI)。
    结果:搜索产生了8项符合条件的观察性研究,涵盖了6727例患者。抗凝患者的0至12个月死亡率最低(2.0%,95%CI0.4-9.7%)和抗凝联合抗血小板治疗(2.2%,95%CI0.9-5.5%),最高的是没有抗血栓药物的患者(7.3%,95%CI3.6-14.2%)。手术三个月后,抗凝患者的死亡率较低(0.5%,95%CI0.1-2.6%)高于抗血小板患者(3.0%,95%CI1.2-7.4%)和不含抗血栓药的(3.5%,95%CI1.3-9.3%)。在药物策略之间没有观察到卒中发生率差异的合格证据。在0至12个月的随访中,所有抗血栓治疗方案均导致出血率增加(抗血小板4.2%,95%CI2.9-6.1%;抗凝7.5%,95%CI3.8-14.4%;抗凝联合抗血小板治疗8.3%,95%CI5.7-11.8%)与无抗血栓药物(1.1%,95%CI0.4-3.4%)。在3至12个月的随访中,与未使用抗血栓药物的患者相比,使用抗凝联合抗血小板治疗的患者的出血率增加了8倍.总的来说,证据的确定性被列为非常低。
    结论:尽管这项荟萃分析显示,抗凝治疗在生物学SAVR后1年的死亡率方面具有有益的趋势,并且表明持续抗凝治疗超过3个月的潜在优势,它受到非常低的证据确定性的限制。谨慎解释的必要性和迫切需要更可靠的随机研究强调了在该患者人群中确定最佳抗血栓策略的复杂性。
    BACKGROUND: We aimed to summarise the existing knowledge regarding antithrombotic medications following surgical aortic valve replacement (SAVR) using a biological valve prosthesis.
    METHODS: We performed a meta-analysis of studies that reported the results of using antithrombotic medication to prevent thromboembolic events after SAVR using a biological aortic valve prosthesis and recorded the outcomes 12 months after surgery. Since no randomised controlled trials were identified, observational studies were included. The analyses were conducted separately for periods of 0-12 months and 3-12 months after surgery. A random effects model was used to calculate pooled outcome event rates and 95% confidence intervals (CIs).
    RESULTS: The search yielded eight eligible observational studies covering 6727 patients overall. The lowest 0- to 12-month mortality was observed in patients with anticoagulation (2.0%, 95% CI 0.4-9.7%) and anticoagulation combined with antiplatelet therapy (2.2%, 95% CI 0.9-5.5%), and the highest was in patients without antithrombotic medication (7.3%, 95% CI 3.6-14.2%). Three months after surgery, mortality was lower in anticoagulant patients (0.5%, 95% CI 0.1-2.6%) than in antiplatelet patients (3.0%, 95% CI 1.2-7.4%) and those without antithrombotics (3.5%, 95% CI 1.3-9.3%). There was no eligible evidence of differences in stroke rates observed among medication strategies. At 0- to 12-month follow-up, all antithrombotic treatment regimens resulted in an increased bleeding rate (antiplatelet 4.2%, 95% CI 2.9-6.1%; anticoagulation 7.5%, 95% CI 3.8-14.4%; anticoagulation combined with antiplatelet therapy 8.3%, 95% CI 5.7-11.8%) compared to no antithrombotic medication (1.1%, 95% CI 0.4-3.4%). At 3- to 12-month follow-up, there was up to an eight-fold increase in the bleeding rate in patients with anticoagulation combined with antiplatelet therapy when compared to those with no antithrombotic medication. Overall, the evidence certainty was ranked as very low.
    CONCLUSIONS: Although this meta-analysis reveals that anticoagulation therapy has a beneficial tendency in terms of mortality at 1 year after biological SAVR and suggests potential advantages in continuing anticoagulation beyond 3 months, it is limited by very low evidence certainty. The imperative for cautious interpretation and the urgent need for more robust randomised research underscore the complexity of determining optimal antithrombotic strategies in this patient population.
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  • 文章类型: Case Reports
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  • 文章类型: Journal Article
    关闭儿童的先天性体壁缺陷对儿科外科医生来说可能是一项具有挑战性的任务。生物假体已越来越多地用于成人患者的高风险伤口闭合,并在儿科人群中使用。这里,我们的目的是研究用组织工程的无细胞牛心包补片修复腹部伤口的效果。
    在21个月的时间里,共有15名儿童接受了生物假体腹部伤口修复,即,我们研究所的牛心包贴片。患者人口统计学,缺陷的原因,补丁使用的迹象,感染率,术后恢复,复发,和结果进行了研究。
    共有15例患者接受了无细胞牛心包补片的腹壁封闭。15名患者中有9名是新生儿,其中五个患有胃裂,两个人患有先天性膈疝,还有两个大脐膨出破裂。其余6名患者中,2人是膀胱外翻患者,2名患有先天性膈疝伴切口疝的大龄儿童,和2个是大龄儿童患有脐膨出。在五个腹裂患者中,其中2人在术后早期因脓毒症死亡.其余13例患者伤口愈合,2例患者皮肤轻度裂开。只有一个孩子复发了。
    无细胞牛心包补片重建是高危腹部创伤儿童的可行选择,因为它可以实现无张力修复,愈合良好,并发症少。复发,如果有的话,可能会随着时间的推移而消失,因为假体的重塑会随着儿童体壁的生长而发生。
    UNASSIGNED: Closure of congenital body wall defects in children can be a challenging task for the pediatric Surgeon. Biological prosthesis has been increasingly used for high-risk wound closure in adult patients with excellent outcomes and use in the pediatric population has also been reported. Here, we aim to study the outcome of abdominal wound repair with a tissue-engineered acellular bovine pericardial patch.
    UNASSIGNED: Over a period of 21 months, a total of 15 children had undergone abdominal wound repair with bioprostheses, i.e., bovine pericardial patch at our institute. Patient demographics, cause of defect, an indication of patch use, rate of infection, postoperative recovery, recurrence, and outcome were studied.
    UNASSIGNED: A total of 15 patients underwent abdominal wall closure with acellular bovine pericardial patch. Nine out of 15 patients were neonates, of whom five had gastroschisis, two had a congenital diaphragmatic hernia, and two had ruptured omphalocele major. Of the rest 6 patients, 2 were patients of bladder exstrophy, 2 were older children of congenital diaphragmatic hernia with incisional hernias, and 2 were older children with omphalocele major. Out of the five patients with gastroschisis, two died during the early postoperative period due to sepsis. The wound healed in the rest 13 patients with mild skin dehiscence in two patients. Only one child had a recurrence.
    UNASSIGNED: Reconstruction with acellular bovine pericardial patch is a viable option in children with high-risk abdominal wounds as it allows tensionless repair with excellent healing and minimal complications. Recurrence, if any, may disappear with time as remodeling of the prosthesis occurs along with the growth of the body wall of the child.
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  • 文章类型: Journal Article
    房室(AV)瓣膜疾病是我们印度次大陆的主要负担,风湿性心脏病仍然很普遍,与西方世界相比,在退化性心脏病更为普遍的地方。全球,每年进行近30万例瓣膜置换手术,但并非没有并发症。这些挑战可以是多维和多标量的,具有与机械和生物假体心脏瓣膜和环相互作用的天然患者组织的宏观和微观特性。了解AV瓣膜的复杂多变的解剖结构对于了解疾病的确切病理生理学并决定选择的治疗至关重要。
    Atrioventricular (AV) valve disease is a major burden in our Indian subcontinent, where rheumatic heart disease is still prevalent, when compared to the Western world, where degenerative heart disease is more prevalent. Worldwide, nearly 300,000 valve replacements are done every year but not without complications. These challenges can be multidimensional and multiscalar with the macroscopic and microscopic properties of the native patient tissue interacting with the mechanical and bioprosthetic heart valves and rings. Understanding the complex and variable anatomy of the AV valves is essential to know the exact pathophysiology of the disease and to decide the treatment of choice.
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  • 文章类型: Case Reports
    背景:抗磷脂综合征合并心脏瓣膜病的孕妇的围手术期处理和心脏手术很少报道。
    方法:我们描述了一例在妊娠18周时发生生物瓣膜衰竭和抗磷脂综合征的孕妇进行经导管二尖瓣瓣膜置换术的病例。该患者在妊娠34周时进行了剖宫产分娩,导致一个健康的婴儿出生。
    结论:经心尖二尖瓣瓣膜手术可在抗磷脂综合征合并二尖瓣生物瓣膜衰竭的孕妇中获得安全的母婴结局。这一程序的成功强调了多学科团队合作的重要性。
    BACKGROUND: Perioperative management and cardiac surgery in pregnant women with anti-phospholipid syndrome combined with heart valve disease have been rarely reported.
    METHODS: We describe a case of transcatheter mitral valve-in-valve replacement in a pregnant woman with bioprosthetic valve failure and anti-phospholipid syndrome at 18 weeks\' gestation. The patient underwent a cesarean section delivery at 34 weeks of gestation, resulting in the birth of a healthy baby.
    CONCLUSIONS: Transapical mitral valve-in-valve surgery resulted in safe maternal and infant outcomes in a pregnant woman with anti-phospholipid syndrome combined with mitral bioprosthetic valve failure. The success of this procedure underscored the importance of multidisciplinary teamwork.
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  • 文章类型: Journal Article
    背景:经导管肺动脉瓣置换术(TPVR)的研究显示了良好的临床和血流动力学结果。我们的研究分析了东南亚接受旋律瓣膜植入术患者的中期临床和血流动力学结果。
    方法:招募患有环形导管或生物瓣膜并经历术后右心室流出道(RVOT)功能障碍的患者进行旋律TPVR。
    结果:我们的队列(n=14)在儿童和成人患者之间平均分配。中位年龄为19岁(8-38岁),男女比例为6:1,中位随访期为48个月(16-79个月),最小的病人是一个8岁的男孩,体重18公斤。所有TPVR手术都顺利且成功,没有立即死亡或导管破裂。植入物的主要适应症是合并狭窄和反流。平均导管直径为21±2.3mm。71.4%的无旋律瓣膜支架骨折(MSFs)患者同时进行支架置入术。植入瓣膜尺寸包括22-mm(64.3%),20毫米(14.3%),和18毫米(21.4%)。在TPVR之后,在出院时,整个RVOT的平均梯度从41mmHg(10-48mmHg)显着降低到16mmHg(6-35mmHg),p<0.01。2例(14.3%)被诊断为晚期随访感染性心内膜炎(IE)。在79个月的随访中,IE的总体自由度为86%。三名患者(21.4%)出现进行性RVOT梯度。
    结论:对于东南亚患有RVOT功能障碍的患者,在血流动力学和临床改善方面,旋律TPVR结果与美国患者报告的结果相似。采用支架置入前策略,未观察到MSF。植入后的残余狭窄和RVOT的进行性狭窄需要长期监测和再干预。最后,尽管积极预防和围手术期预防细菌性心内膜炎,IE仍然是一个值得关注的问题。
    BACKGROUND: Studies of transcatheter pulmonary valve replacement (TPVR) with the Melody valve have demonstrated good clinical and hemodynamic outcomes. Our study analyzes the midterm clinical and hemodynamic outcomes for patients who underwent Melody valve implantation in Southeast Asia.
    METHODS: Patients with circumferential conduits or bioprosthetic valves and experiencing post-operative right ventricular outflow tract (RVOT) dysfunction were recruited for Melody TPVR.
    RESULTS: Our cohort (n = 14) was evenly divided between pediatric and adult patients. The median age was 19 years (8-38 years), a male-to-female ratio of 6:1 with a median follow-up period of 48 months (16-79 months), and the smallest patient was an 8-year-old boy weighing 18 kg. All TPVR procedures were uneventful and successful with no immediate mortality or conduit rupture. The primary implant indication was combined stenosis and regurgitation. The average conduit diameter was 21 ± 2.3 mm. Concomitant pre-stenting was done in 71.4% of the patients without Melody valve stent fractures (MSFs). Implanted valve size included 22-mm (64.3%), 20-mm (14.3%), and 18-mm (21.4%). After TPVR, the mean gradient across the RVOT was significantly reduced from 41 mmHg (10-48 mmHg) to 16 mmHg (6-35 mmHg) at discharge, p < 0.01. Late follow-up infective endocarditis (IE) was diagnosed in 2 patients (14.3%). Overall freedom from IE was 86% at 79 months follow-up. Three patients (21.4%) developed progressive RVOT gradients.
    CONCLUSIONS: For patients in Southeast Asia with RVOT dysfunction, Melody TPVR outcomes are similar to those reported for patients in the US in terms of hemodynamic and clinical improvements. A pre-stenting strategy was adopted and no MSFs were observed. Post-implantation residual stenosis and progressive stenosis of the RVOT require long term monitoring and reintervention. Lastly, IE remained a concern despite vigorous prevention and peri-procedural bacterial endocarditis prophylaxis.
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  • 文章类型: Journal Article
    目的:可从随机试验中获得有限的数据,这些试验比较了经导管主动脉瓣置换术(TAVR)和手术在不同风险患者中的结局,随访时间至少为4年或更长。在这个大的,基于人群的队列研究,研究了使用手术植入生物假体(sB-AVR)或TAVR进行主动脉瓣置换术(AVR)治疗严重主动脉瓣狭窄的患者的长期死亡率和发病率.
    方法:分析了2010年至2020年奥地利保险基金的个人数据。主要结果是全因死亡率,在总体和倾向得分匹配的人群中进行评估。次要结果包括再次手术和心血管事件。
    结果:从2010年1月到2020年12月,共有18882例患者接受了sB-AVR(n=11749;62.2%)或TAVR(n=7133;37.8%);中位随访时间为5.8年(95%CI5.7-5.9)(最长12.3年)。与sB-AVR相比,TAVR的全因死亡率风险更高:风险比(HR)1.552,95%置信区间(CI)1.469-1.640,p<0.001;倾向评分匹配HR1.510,1.403-1.625,p<0.001。sB-AVR的估计中位生存期为8.8年(95%CI8.6-9.1),TAVR为5年(4.9-5.2)。sB-AVR的5年生存率估计为0.664(0.664-0.686),TAVR的5年生存率为0.409(0.378-0.444),和0.690(0.674-0.707)和0.560(0.540-0.582),分别,倾向得分匹配。对年龄在65-75岁和>75岁的患者的单独亚组分析表明,两组中选择sB-AVR的患者均有显着的生存益处。死亡率的其他预测因素是年龄,性别,以前的心力衰竭,糖尿病,和慢性肾病。
    结论:在这项基于人群的国家回顾性研究中,在≥65岁的重度患者中,与sB-AVR相比,选择TAVR与全因死亡率显著相关,症状性主动脉瓣狭窄>2年随访。
    OBJECTIVE: Limited data are available from randomized trials comparing outcomes between transcatheter aortic valve replacement (TAVR) and surgery in patients with different risks and with follow-up of at least 4 years or longer. In this large, population-based cohort study, long-term mortality and morbidity were investigated in patients undergoing aortic valve replacement (AVR) for severe aortic stenosis using a surgically implanted bioprosthesis (surgical/biological aortic valve replacement; sB-AVR) or TAVR.
    METHODS: Individual data from the Austrian Insurance Funds from 2010 through 2020 were analysed. The primary outcome was all-cause mortality, assessed in the overall and propensity score-matched populations. Secondary outcomes included reoperation and cardiovascular events.
    RESULTS: From January 2010 through December 2020, a total of 18 882 patients underwent sB-AVR (n = 11 749; 62.2%) or TAVR (n = 7133; 37.8%); median follow-up was 5.8 (95% CI 5.7-5.9) years (maximum 12.3 years). The risk of all-cause mortality was higher with TAVR compared with sB-AVR: hazard ratio 1.552, 95% confidence interval (CI) 1.469-1.640, P < 0.001; propensity score-matched hazard ratio 1.510, 1.403-1.625, P < 0.001. Estimated median survival was 8.8 years (95% CI 8.6-9.1) with sB-AVR versus 5 years (4.9-5.2) with TAVR. Estimated 5-year survival probability was 0.664 (0.664-0.686) with sB-AVR versus 0.409 (0.378-0.444) with TAVR overall, and 0.690 (0.674-0.707) and 0.560 (0.540-0.582), respectively, with propensity score matching. Separate subgroup analyses for patients aged 65-75 years and >75 years indicated a significant survival benefit in patients selected for sB-AVR in both groups. Other predictors of mortality were age, sex, previous heart failure, diabetes and chronic kidney disease.
    CONCLUSIONS: In this retrospective national population-based study, selection for TAVR was significantly associated with higher all-cause mortality compared with sB-AVR in patients ≥65 years with severe, symptomatic aortic stenosis in the >2-year follow-up.
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