Bioprosthesis

生物假体
  • 文章类型: Journal Article
    指南指导的药物依从性被认为是心脏手术后的重要质量指标。我们评估了使用生物假体进行主动脉瓣置换术(sAVR)后使用华法林的美国心脏病学会/美国心脏协会指南的依从性,并检查了抗凝实践随时间的潜在变化。
    使用OptumLabs数据仓库,我们调查了有或没有冠状动脉搭桥的生物假体sAVR的成年患者(2007-2019).术后早期华法林使用定义为sAVR后≥30天连续处方覆盖。
    在10730名患有sAVR的成年患者中,3071(28.6%)术后早期接受华法林治疗。华法林处方覆盖率的中位数为4.5个月(四分位数间距,3.0-8.9个月)。然而,只有11.1%(736/6634)的华法林处方覆盖率为3~6个月,符合最新指南.在13年期间,每年的华法林处方率没有显着变化(P=0.386)。与非华法林组患者相比,接受华法林处方的人年龄较大,更可能是男性,并且患有心房颤动,充血性心力衰竭,慢性肺病,和CHA2DS2-VASc评分≥2;接受其他心脏药物处方的患者使用华法林也更多(P<0.05)。
    华法林处方反映的sAVR后抗凝治疗可能未得到充分利用;华法林的使用率在过去十年中没有变化。虽然需要更多的研究来证实sAVR后早期抗凝的益处,这些结果表明,大多数临床医生并未遵循指南建议.这些发现突出了质量改进的潜在重要领域。
    Guideline-directed medication adherence is considered an important quality measure after cardiac surgery. We evaluated compliance with the American College of Cardiology/American Heart Association guidelines for warfarin use after surgical aortic valve replacement (sAVR) using bioprostheses and examined potential variations in anticoagulation practice over time.
    Using the OptumLabs Data Warehouse, we investigated adult patients having bioprosthetic sAVR with or without coronary artery bypass (2007-2019). Early postoperative warfarin use was defined as ≥30 days of continuous prescription coverage after sAVR.
    Among 10 730 adult patients having sAVR, 3071 (28.6%) received warfarin early postoperatively. Median length of warfarin prescription coverage was 4.5 months (interquartile range, 3.0-8.9 months). However, only 11.1% (736/6634) had warfarin prescription coverage of 3 to 6 months in compliance with the most recent guidelines. Yearly warfarin prescription rate did not change significantly during the 13-year period (P = .386). Compared with patients from the non-warfarin group, those receiving warfarin prescriptions were older and more likely to be male and to have atrial fibrillation, congestive heart failure, chronic pulmonary disease, and CHA2DS2-VASc score ≥2; warfarin use was also greater in patients receiving prescriptions for other cardiac medications (P < .05).
    Anticoagulation after sAVR as reflected by warfarin prescriptions may be underused; the rates of warfarin use have not changed in the last decade. Although additional studies are needed to confirm the benefit of early anticoagulation after sAVR, these results indicate that guideline recommendations are not followed by most clinicians. The findings highlight a potentially important area for quality improvement.
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  • 文章类型: Journal Article
    OBJECTIVE: The long-term durability of transcatheter aortic bioprosthetic valves continues to be a major concern. Standardized criteria of the structural valve deterioration (SVD) and bioprosthetic valve failure (BVF) have recently been defined. Limited studies have evaluated the long-term durability of transcatheter aortic valve implantation (TAVI) according to these new definitions. We aim to analyze the durability of TAVI beyond 5 years and to report the frequency of SVD and BVF.
    METHODS: A total of 89 patients who had undergone TAVI and had theoretically completed at least 5 years after the procedure were included. Either a Medtronic CoreValve or an Edwards SAPIEN XT valve were implanted in the patients. New standardized definitions were used to evaluate SVD and BVF.
    RESULTS: The mean age of the patients was 78.70±6.95 years. SVD occured in 4 (4.5%) patients during 6 years of follow-up. Severe SVD was observed in 2 patients (2.2%), and these patients had the New York Heart Association class II symptoms. Both patients with severe SVD also met the criteria of BVF. Moderate SVD was observed in 2 patients (2.2%), and these patients had no valve-related symptoms. Of the 4 SVD cases, 2 were associated with increased mean transaortic gradients, whereas the remaining 2 cases were associated with intraprosthetic aortic regurgitation. All patients with SVD are still alive, and none of them have required aortic valve reintervention.
    CONCLUSIONS: Although first-generation TAVI devices were used, we determined the low rate of SVD and BVF at the 6-year follow-up. It may be suggested that there is no major concern associated with TAVI even with first-generation devices regarding long-term durability.
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  • 文章类型: Journal Article
    Durability of sutureless aortic bioprosthetic valves remains a major issue. The aim of this study was to assess structural valve deterioration (SVD) and bioprosthetic valve failure (BVF) of the Perceval bioprosthesis using the new proposed standardized definitions.
    All patients who underwent aortic valve replacement with sutureless Perceval S prostheses up to September 2016 were included. Clinical and echocardiographic follow-up was performed. New standardized definitions were used to assess the durability of sutureless bioprosthetic valves. From 2013 to 2016, 214 patients were included.
    The mean age and EuroSCORE II were 79 years and 2.74. Thirty-day mortality was 0.47%. The survival rate was 96.8%, 88.1% and 85.7% at 1, 3 and 4 years, respectively. The median echocardiographic follow-up was 3.28 years. The mean pressure gradient was 11.3 mmHg. No cases showed evidence of severe SVD, 17 patients had moderate SVD with a mean pressure gradient of 24 mmHg and 8 patients had definite late BVF. The incidence of moderate SVD and BVF at 4 years was 8.8% and 2.9%, respectively.
    Mid-term follow-up to 6.3 years after aortic valve replacement with the Perceval bioprosthesis documents favourable haemodynamic and clinical outcomes and low rates of SVD and BVF.
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  • 文章类型: Journal Article
    Comprehensive information on the characteristics of surgical heart valves (SHVs) is essential for optimal valve selection. Such information is also important in assessing SHV function after valve replacement. Despite the existing regulatory framework for SHV sizing and labelling, this information is challenging to obtain in a uniform manner for various SHVs. To ensure that clinicians are adequately informed, the European Association for Cardio-Thoracic Surgery (EACTS), The Society of Thoracic Surgeons (STS) and American Association for Thoracic Surgery (AATS) set up a Task Force comprised of cardiac surgeons, cardiologists, engineers, regulatory bodies, representatives of the International Organization for Standardization and major valve manufacturers. Previously, the EACTS-STS-AATS Valve Labelling Task Force identified the most important problems around SHV sizing and labelling. This Expert Consensus Document formulates recommendations for providing SHV physical dimensions, intended implant position and hemodynamic performance in a transparent, uniform manner. Furthermore, the Task Force advocates for the introduction and use of a standardized chart to assess the probability of prosthesis-patient mismatch and calls valve manufacturers to provide essential information required for SHV choice on standardized Valve Charts, uniformly for all SHV models.
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  • 文章类型: Case Reports
    The aim of this study was to present a valve-in-valve (ViV) case and a step-by-step guideline on how to perform this procedure.
    A 51-year-old female with a history of rheumatic heart disease and tricuspid valve replacement presented functional class deterioration, a transesophageal echocardiogram (TEE) revealed prosthetic dysfunction due to thrombosis; therefore, a valvular replacement with a 27 mm bioprosthesis (Carpentier-Edwards Perimount) was performed without complication. 3 years after the procedure, the patients presented functional class deterioration (NYHA-III) with tricuspid dysfunction by TEE and the heart team decided to perform a transcatheter tricuspid ViV replacement.
    El objetivo de este artículo es presentar un caso clínico de un paciente en el cual se realizó el procedimiento valve-in-valve (ViV) en la válvula tricúspide junto con una guía de cómo llevar a cabo este procedimiento paso a paso.
    Paciente femenino de 51 años de edad con antecedente de Cardiopatía Reumática presenta deterioro en clase funcional encontrándose por ecocardiografía transesofágica (ETE) disfunción de válvula protésica tricúspide secundario a trombosis, se realiza recambio valvular con prótesis biológica 27 mm (Carpentier Edwards Perimount) sin complicación. 3 años después, presenta deterioro de la clase funcional (NYHA-III) y se evidencia en ETE disfunción protésica tricúspide por lo cual se decide realizar un reemplazo ViV tricúspide transcatéter.
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  • 文章类型: Comparative Study
    Prosthetic heart valve interventions continue to evolve with new innovations in surgical and transcatheter technologies. We compared the recommendations from the 2017 American College of Cardiology/American Heart Association guidelines for management of patients with prosthetic heart valves with the 2017 European Society of Cardiology guidelines. The 2 documents differed regarding recommendations for follow-up imaging, the choice of biological versus mechanical prosthesis, bridging therapies, role of aspirin, use of fibrinolytic therapy for prosthetic valve thrombosis, and management of paravalvular regurgitation. This review highlights the differences between the 2 guidelines, summarizes new evidence, and offers recommendations for the management of patients with prosthetic heart valves in these areas of controversy.
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  • 文章类型: Journal Article
    The Academic Research Consortium (ARC)-2 initiative revisited the clinical and angiographic end point definitions in coronary device trials, proposed in 2007, to make them more suitable for use in clinical trials that include increasingly complex lesion and patient populations and incorporate novel devices such as bioresorbable vascular scaffolds. In addition, recommendations for the incorporation of patient-related outcomes in clinical trials are proposed. Academic Research Consortium-2 is a collaborative effort between academic research organizations in the United States and Europe, device manufacturers, and European, US, and Asian regulatory bodies. Several in-person meetings were held to discuss the changes that have occurred in the device landscape and in clinical trials and regulatory pathways in the last decade. The consensus-based end point definitions in this document are endorsed by the stakeholders of this document and strongly advocated for clinical trial purposes. This Academic Research Consortium-2 document provides further standardization of end point definitions for coronary device trials, incorporating advances in technology and knowledge. Their use will aid interpretation of trial outcomes and comparison among studies, thus facilitating the evaluation of the safety and effectiveness of these devices.
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  • 文章类型: Journal Article
    Durability of transcatheter aortic bioprosthetic valves remains a major issue. Standardised definitions of deterioration and failure of bioprosthetic valves have recently been proposed. The aim of this study was to assess structural transcatheter valve deterioration (SVD) and bioprosthetic valve failure (BVF) using these new definitions.
    All TAVI patients implanted up to September 2012 with a minimal theoretical five-year follow-up were included. Systematic clinical and echocardiographic follow-up was performed annually. New standardised definitions were used to assess durability of transcatheter aortic bioprosthetic valves. From 2002 to 2012, 378 patients were included. Mean age and logistic EuroSCORE were 83.3±6.8 years and 22.8±13.1%. Thirty-day mortality was 13.2%. Nine patients had SVD including two severe forms and two patients had definite late BVF. The incidence of SVD and BVF at eight years was 3.2% (95% CI: 1.45-6.11) and 0.58% (95% CI: 0.15-2.75), respectively.
    Even though limited by the poor survival of the very high-risk/compassionate early population, our data do not demonstrate any alarm concerning transcatheter aortic valve durability. Careful prospective assessment in younger and lower-risk patients and comparison with surgical bioprosthetic valves are required for further assessment of the long-term durability of transcatheter valves.
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  • 文章类型: Journal Article
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  • 文章类型: Editorial
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