Généreux Philippe, Wróbel Krzysztof, Rinaldi Michael J, Modine Thomas, Bapat Vinayak, Ninios Vlasis, Sorajja Paul
Gagnon Cardiovascular Institute at Morristown Medical Center, Morristown, New Jersey, USA.
Warsaw Medicover Hospital, Warsaw, Poland.
Struct Heart. 2024 Mar 15;8(3):100294. doi: 10.1016/j.shj.2024.100294. eCollection 2024 May.
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.
Six patients with moderate or severe MAC who were treated with AltaValve TMVR had procedural and mid-term outcomes available.
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.
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.
二尖瓣反流（MR）和二尖瓣环钙化（MAC）患者的治疗选择有限。当前经导管二尖瓣置换术（TMVR）技术的局限性包括高筛查失败率、左心室流出道梗阻风险增加以及高残余反流。本研究的目的是评估采用AltaValve系统（4C Medical，明尼苏达州枫树谷）进行的TMVR的疗效，该系统是一种具有心房固定功能的瓣上环TMVR，用于治疗重度MR和中度或重度MAC患者。
6例接受AltaValve TMVR治疗的中度或重度MAC患者有手术及中期结果数据。
所有患者均取得技术成功。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、装置位置不当、栓塞或血栓形成。1例患者术后3天因经心尖入路相关并发症死亡。所有其他患者均顺利出院。30天时的超声心动图评估显示所有患者的MR完全消失，1例患者有轻度MR，平均二尖瓣跨瓣压差为3.7±1.4 mmHg。在30天随访时，所有患者的心功能分级均为纽约心脏协会I/II级，与基线相比有显著改善。
对于重度MR和重度MAC患者，AltaValve TMVR技术可能是一种可行的治疗选择。心房固定可将左心室流出道梗阻风险降至最低，并可能扩大可治疗患者群体，尤其是MAC患者。
