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REPRISE III试验的二次分析:撤药后莲花瓣膜的持久性

Secondary analysis of REPRISE III trial: The Lotus valve's persistence after withdrawal.

作者信息

Kotit Susy

机构信息

Aswan Heart Centre, Aswan, Egypt.

出版信息

Glob Cardiol Sci Pract. 2023 Sep 30;2023(4):e202330. doi: 10.21542/gcsp.2023.30.

DOI:10.21542/gcsp.2023.30
PMID:38404629
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10886713/
Abstract

INTRODUCTION

Aortic stenosis (AS) is the leading heart valve disease in developed countries, often caused by calcific degeneration. In low-and-middle-income countries, it's primarily due to RHD. Prevalence of AS increases with age and up to 22.8% of those affected over the age of 75. While surgical aortic valve replacement is standard treatment for AS, many older individuals are not ideal candidates. Transcatheter aortic valve replacement (TAVR) offers an alternative. The REPRISE III trial showed the Lotus valve outperformed the CoreValve/EvolutR TAVR valves in various metrics over 2 years. Despite its success and over 10,000 implantations, the Lotus valve was pulled from the market, highlighting the need to understand its long-term outcomes. Study and results: In the REPRISE III trial, the long-term outcomes of TAVR using the Lotus valve were compared to the CoreValve/EvolutR over 5 years across 55 global centers. Of the participants, 581 (95.7%) used the Lotus valve and 285 (93.4%) used CoreValve/EvolutR. Event rates for all-cause mortality were similar between the groups, but the Lotus valve group had lower rates of disabling stroke and pacemaker implantation. The Lotus valve showed a higher aortic gradient but lower effective orifice area. Additionally, the Lotus valve had reduced mild PVL, valve malpositioning, and the need for a second valve. Both groups showed comparable long-term improvements in heart and cardiomyopathy assessments.

LESSONS LEARNED

The REPRISE III analysis highlights the favourable long-term outcomes of the Lotus valve and CoreValve/EvolutR for high-risk surgical patients. These findings underscore the importance of ongoing management post-valve procedure and the potential advantages of the Lotus valve design. Further studies comparing these valves to surgery will inform aortic stenosis management and potentially expand TAVR indications. The future goal is to develop a tissue-engineered living heart valve to improve survival and quality of life.

摘要

引言

在发达国家,主动脉瓣狭窄(AS)是主要的心脏瓣膜疾病,通常由钙化变性引起。在中低收入国家,其主要病因是风湿性心脏病(RHD)。AS的患病率随年龄增长而上升,75岁以上患者中患病率高达22.8%。虽然外科主动脉瓣置换术是AS的标准治疗方法,但许多老年患者并非理想的手术候选人。经导管主动脉瓣置换术(TAVR)提供了一种替代方案。REPRISE III试验表明,Lotus瓣膜在两年内的各项指标上均优于CoreValve/EvolutR TAVR瓣膜。尽管Lotus瓣膜取得了成功且植入量超过10000例,但它仍被撤出市场,这凸显了了解其长期疗效的必要性。研究与结果:在REPRISE III试验中,全球55个中心对使用Lotus瓣膜的TAVR和CoreValve/EvolutR进行了为期5年的长期疗效比较。参与者中,581人(95.7%)使用Lotus瓣膜,285人(93.4%)使用CoreValve/EvolutR。两组全因死亡率相似,但Lotus瓣膜组致残性中风和起搏器植入率较低。Lotus瓣膜显示出较高的主动脉梯度,但有效瓣口面积较小。此外,Lotus瓣膜的轻度瓣周漏、瓣膜错位及二次瓣膜植入需求减少。两组在心脏和心肌病评估方面均显示出相当的长期改善。

经验教训

REPRISE III分析突出了Lotus瓣膜和CoreValve/EvolutR对高危手术患者的良好长期疗效。这些发现强调了瓣膜手术后持续管理的重要性以及Lotus瓣膜设计的潜在优势。将这些瓣膜与手术进行比较的进一步研究将为主动脉瓣狭窄的管理提供参考,并可能扩大TAVR的适应症。未来的目标是开发一种组织工程化的活体心脏瓣膜,以提高生存率和生活质量。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/65a5/10886713/38e88f636619/gcsp-2023-4-e202330-g005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/65a5/10886713/553d6e5f283c/gcsp-2023-4-e202330-g001.jpg
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https://cdn.ncbi.nlm.nih.gov/pmc/blobs/65a5/10886713/553d6e5f283c/gcsp-2023-4-e202330-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/65a5/10886713/c84cc4ea309f/gcsp-2023-4-e202330-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/65a5/10886713/97a2a3e6b464/gcsp-2023-4-e202330-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/65a5/10886713/50b32724fd63/gcsp-2023-4-e202330-g004.jpg
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