Weber Alberto, Taramasso Maurizio, Podkopajev Andrej, Janusauskas Vilius, Zakarkaite Diana, Vogel Rolf, Carrel Thierry
Heart Center, Hirslanden Clinic, Zurich, Switzerland.
Vilnius University Clinic of Cardiac and Vascular Diseases, Vilnius, Lithuania.
JTCVS Open. 2021 Oct 29;8:280-289. doi: 10.1016/j.xjon.2021.08.041. eCollection 2021 Dec.
This study examines the early and midterm safety, efficacy, and durability of mitral valve repair for primary mitral regurgitation (MR) using the ChordArt device (CoreMedic) for chordal replacement.
Five patients with symptomatic severe primary degenerative MR due to isolated central posterior leaflet prolapse/flail were treated with the ChordArt device in a transseptal surgical approach and followed prospectively with periodical clinical and echocardiographic assessments for 2 years.
Reduction of MR immediately after the implantation of artificial chords was achieved in all patients showing no or trace MR (<1+/4+). In all patients, MR <1+ was maintained during 24 months of follow-up. No dehiscence, detachment, or dislocation of the implanted ChordArt devices was observed. Transthoracic echocardiography showed that left ventricle end diastolic diameter significantly decreased during the whole follow-up period in comparison to baseline condition, especially at discharge and 1-month follow-up. Left ventricle end systolic diameter also significantly decreased during the whole follow-up period in comparison to baseline condition. Left atrial volume significantly decreased during the follow-up period in comparison to discharge. No major adverse events, as defined per protocol, were observed during the intervention or during the follow-up period.
The ChordArt device allows successful treatment of primary degenerative MR due to posterior mitral leaflet prolapse or flail, with a good safety profile and promising immediate clinical and echocardiographic benefits that are confirmed up to 24 months.
本研究探讨使用ChordArt装置（CoreMedic）进行腱索置换治疗原发性二尖瓣反流（MR）的早期和中期安全性、有效性及耐久性。
5例因孤立性中央后叶脱垂/连枷导致有症状的严重原发性退行性MR患者，采用经房间隔手术方法使用ChordArt装置进行治疗，并进行前瞻性随访，定期进行临床和超声心动图评估，为期2年。
所有患者在植入人工腱索后即刻实现MR减少，显示无MR或微量MR（<1+/4+）。所有患者在24个月的随访期间MR均维持在<1+。未观察到植入的ChordArt装置出现裂开、脱离或脱位。经胸超声心动图显示，与基线状态相比，整个随访期间左心室舒张末期直径显著减小，尤其是在出院时和1个月随访时。与基线状态相比，整个随访期间左心室收缩末期直径也显著减小。随访期间左心房容积与出院时相比显著减小。在干预期间或随访期间未观察到按照方案定义的重大不良事件。
ChordArt装置能够成功治疗因二尖瓣后叶脱垂或连枷导致的原发性退行性MR，具有良好的安全性，且有令人满意的即刻临床和超声心动图获益，这些获益在24个月时得到证实。
