AltaValve Atrial Fixation System for the Treatment of Severe Mitral Regurgitation and Mitral Annular Calcification

IF 1.4 Q3 CARDIAC & CARDIOVASCULAR SYSTEMS
Philippe Généreux MD , Krzysztof Wróbel MD, PhD , Michael J. Rinaldi MD , Thomas Modine MD, PhD , Vinayak Bapat MD , Vlasis Ninios MD , Paul Sorajja MD
{"title":"AltaValve Atrial Fixation System for the Treatment of Severe Mitral Regurgitation and Mitral Annular Calcification","authors":"Philippe Généreux MD ,&nbsp;Krzysztof Wróbel MD, PhD ,&nbsp;Michael J. Rinaldi MD ,&nbsp;Thomas Modine MD, PhD ,&nbsp;Vinayak Bapat MD ,&nbsp;Vlasis Ninios MD ,&nbsp;Paul Sorajja MD","doi":"10.1016/j.shj.2024.100294","DOIUrl":null,"url":null,"abstract":"<div><h3>Background</h3><p>Treatment options for patients with mitral regurgitation (MR) and mitral annular calcification (MAC) are limited. The limitations of current transcatheter mitral valve replacement (TMVR) technologies include high screen failure rates, increased risk of left ventricular outflow tract obstruction, and high residual regurgitation. The aim of this study was to evaluate outcomes of TMVR with the AltaValve system (4C Medical, Maple Grove, MN), a supra-annular TMVR with atrial fixation, in patients with severe MR and moderate or severe MAC.</p></div><div><h3>Methods</h3><p>Six patients with moderate or severe MAC who were treated with AltaValve TMVR had procedural and mid-term outcomes available.</p></div><div><h3>Results</h3><p>Technical success was achieved in all patients. Median follow-up was 232 days. At discharge, 80% of patients had none/trace MR, and 20% had mild MR. There was no intraprocedural mortality, device malposition, embolization, or thrombosis. One patient expired 3 days postprocedure due to complications related to the transapical access. All other patients were discharged from the hospital without issues. Echocardiography assessments at 30 days showed complete resolution of MR in all patients, with 1 patient with mild MR and a mean mitral valve gradient of 3.7 ± 1.4 mmHg. All patients were in New York Heart Association Class I/II at 30-day follow-up, showing marked improvement as compared with baseline.</p></div><div><h3>Conclusions</h3><p>In patients with severe MR and severe MAC, the AltaValve TMVR technology may represent a viable treatment option. The atrial fixation minimizes the risk of left ventricular outflow tract obstruction and potentially expands treatable patients, especially in patients with MAC.</p></div>","PeriodicalId":36053,"journal":{"name":"Structural Heart","volume":"8 3","pages":"Article 100294"},"PeriodicalIF":1.4000,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2474870624000253/pdfft?md5=a83d817d1ffc1b4a3a7e2f92204ac847&pid=1-s2.0-S2474870624000253-main.pdf","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Structural Heart","FirstCategoryId":"1085","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S2474870624000253","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"CARDIAC & CARDIOVASCULAR SYSTEMS","Score":null,"Total":0}
引用次数: 0

Abstract

Background

Treatment options for patients with mitral regurgitation (MR) and mitral annular calcification (MAC) are limited. The limitations of current transcatheter mitral valve replacement (TMVR) technologies include high screen failure rates, increased risk of left ventricular outflow tract obstruction, and high residual regurgitation. The aim of this study was to evaluate outcomes of TMVR with the AltaValve system (4C Medical, Maple Grove, MN), a supra-annular TMVR with atrial fixation, in patients with severe MR and moderate or severe MAC.

Methods

Six patients with moderate or severe MAC who were treated with AltaValve TMVR had procedural and mid-term outcomes available.

Results

Technical success was achieved in all patients. Median follow-up was 232 days. At discharge, 80% of patients had none/trace MR, and 20% had mild MR. There was no intraprocedural mortality, device malposition, embolization, or thrombosis. One patient expired 3 days postprocedure due to complications related to the transapical access. All other patients were discharged from the hospital without issues. Echocardiography assessments at 30 days showed complete resolution of MR in all patients, with 1 patient with mild MR and a mean mitral valve gradient of 3.7 ± 1.4 mmHg. All patients were in New York Heart Association Class I/II at 30-day follow-up, showing marked improvement as compared with baseline.

Conclusions

In patients with severe MR and severe MAC, the AltaValve TMVR technology may represent a viable treatment option. The atrial fixation minimizes the risk of left ventricular outflow tract obstruction and potentially expands treatable patients, especially in patients with MAC.

用于治疗严重二尖瓣反流和二尖瓣环钙化的 AltaValve 心房固定系统
背景二尖瓣反流(MR)和二尖瓣环钙化(MAC)患者的治疗方案有限。目前经导管二尖瓣置换(TMVR)技术的局限性包括筛查失败率高、左心室流出道梗阻风险增加以及残余反流率高。本研究旨在评估重度 MR 和中度或重度 MAC 患者使用 AltaValve 系统(4C Medical,Maple Grove,MN)进行 TMVR 的疗效,AltaValve 系统是一种具有心房固定功能的瓣上 TMVR。中位随访时间为 232 天。出院时,80%的患者无/微量 MR,20%的患者有轻度 MR。术中无死亡、装置错位、栓塞或血栓形成。一名患者在术后 3 天因与经心尖入路相关的并发症而死亡。其他患者均顺利出院。30 天后的超声心动图评估显示,所有患者的 MR 均已完全消除,只有一名患者存在轻度 MR,二尖瓣平均梯度为 3.7 ± 1.4 mmHg。结论 对于严重 MR 和严重 MAC 患者,AltaValve TMVR 技术可能是一种可行的治疗方案。心房固定最大程度地降低了左心室流出道阻塞的风险,并有可能扩大可治疗患者的范围,尤其是对于 MAC 患者。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
求助全文
约1分钟内获得全文 求助全文
来源期刊
Structural Heart
Structural Heart Medicine-Cardiology and Cardiovascular Medicine
CiteScore
1.60
自引率
0.00%
发文量
81
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
确定
请完成安全验证×
copy
已复制链接
快去分享给好友吧!
我知道了
右上角分享
点击右上角分享
0
联系我们:info@booksci.cn Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。 Copyright © 2023 布克学术 All rights reserved.
京ICP备2023020795号-1
ghs 京公网安备 11010802042870号
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术官方微信