Procedural and clinical outcomes of patients undergoing a TAVI in TAVI procedure: Rationale and design of the multicentre, prospective, observational ReTAVI registry

IF 4.4 3区 医学 Q1 MEDICINE, GENERAL & INTERNAL
Radoslaw Parma, Michael Joner, Francesco Saia, Thomas Cuisset, Victoria Delgado, Josep Rodes-Cabau, Thomas Modine, Eric Van Belle, Luca Nai Fovino, Uri Landes, Hector Alfonso Alvarez-Covarrubias, Mohamed Abdel-Wahab, Jose Luis Zamorano, Matthias Eden, Filippo Cademartiri, Joanna Nawara Skipirzepa, Jana Kurucova, Daniel Greinert, Peter Bramlage, Giuseppe Tarantini
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引用次数: 0

Abstract

Background

Transcatheter aortic valve implantation (TAVI) is increasingly being used in younger patients and those with lower peri-procedural risk, meaning more patients will live long enough to experience structural valve deterioration (SVD) of the bioprosthesis, indicating repeated TAVI. Experience of repeated TAVI—transcatheter heart valve (THV) implantation into an index THV is limited. This registry aims to assess the peri-procedural and short-term safety, efficacy and durability of repeated TAVI.

Methods

The ReTAVI Prospective observational registry is an investigator-initiated, multicentre, international, prospective registry of patients undergoing repeated TAVI using balloon-expandable SAPIEN prosthesis to evaluate procedural and short-term safety, efficacy and durability as well as anatomical and procedural factors associated with optimal results. The registry will enrol at least 150 patients across 60 high-volume centres. Patients must be ≥18 years old, have had procedural success with their first TAVI, have index THV device failure, intend to undergo repeated TAVI and be considered suitable candidates by their local Heart Team. All patients will undergo a 30-day and 12-month follow-up. The estimated study completion is 2025.

Conclusions

The registry will collect pre-, peri-, postoperative and 12-months data on patients undergoing repeated TAVI procedures with THVs for failure of the index THV and determine VARC-3-defined efficacy and safety at 30 days and functional outcome at 12 months. The registry will expand existing data sets and identify patient characteristics/indicators related to complications and clinical benefits for patients with symptomatic severe calcific degenerative aortic stenosis.

Abstract Image

接受 TAVI 手术的患者的手术和临床结果:多中心、前瞻性、观察性 ReTAVI 登记的原理和设计。
背景:经导管主动脉瓣植入术(TAVI)越来越多地用于年轻患者和手术周风险较低的患者,这意味着更多患者将活到生物假体结构性瓣膜退化(SVD),从而需要重复进行 TAVI。重复TAVI-经导管心脏瓣膜(THV)植入指数THV的经验有限。该登记旨在评估重复 TAVI 的围手术期和短期安全性、有效性和耐久性:ReTAVI前瞻性观察登记是一项由研究者发起的多中心、国际性、前瞻性登记,登记对象为使用球囊扩张型SAPIEN假体进行重复TAVI的患者,目的是评估程序和短期安全性、有效性和耐久性,以及与最佳效果相关的解剖和程序因素。该登记将在 60 个高流量中心登记至少 150 名患者。患者年龄必须≥18岁,首次TAVI手术成功,THV设备出现指数性故障,打算再次进行TAVI手术,并被当地心脏团队视为合适人选。所有患者都将接受 30 天和 12 个月的随访。预计研究将于 2025 年完成:该登记处将收集因指数 THV 失败而接受 THV 重复 TAVI 手术的患者的术前、围手术期、术后和 12 个月的数据,并确定 30 天时 VARC-3 定义的疗效和安全性以及 12 个月时的功能预后。该登记将扩展现有数据集,并确定与无症状严重钙化变性主动脉瓣狭窄患者的并发症和临床获益相关的患者特征/指标。
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来源期刊
CiteScore
9.50
自引率
3.60%
发文量
192
审稿时长
1 months
期刊介绍: EJCI considers any original contribution from the most sophisticated basic molecular sciences to applied clinical and translational research and evidence-based medicine across a broad range of subspecialties. The EJCI publishes reports of high-quality research that pertain to the genetic, molecular, cellular, or physiological basis of human biology and disease, as well as research that addresses prevalence, diagnosis, course, treatment, and prevention of disease. We are primarily interested in studies directly pertinent to humans, but submission of robust in vitro and animal work is also encouraged. Interdisciplinary work and research using innovative methods and combinations of laboratory, clinical, and epidemiological methodologies and techniques is of great interest to the journal. Several categories of manuscripts (for detailed description see below) are considered: editorials, original articles (also including randomized clinical trials, systematic reviews and meta-analyses), reviews (narrative reviews), opinion articles (including debates, perspectives and commentaries); and letters to the Editor.
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