Haddad Raymond N, Daou Linda S, Saliba Zakhia S
Hotel Dieu de France University Medical Center, Department of Pediatrics, Saint Joseph University, Alfred Naccache Boulevard, Achrafieh, Beirut, Lebanon.
Hotel Dieu de France University Medical Center, Department of Pediatric Cardiology, Saint Joseph University, Alfred Naccache Boulevard, Achrafieh, Beirut, Lebanon.
Catheter Cardiovasc Interv. 2020 Sep 1;96(3):E295-E302. doi: 10.1002/ccd.28678. Epub 2019 Dec 30.
To evaluate the safety, efficiency, and midterm outcomes of transcatheter perimembranous ventricular septal defect (pmVSD) closure using the new KONAR-MF™ VSD occluder.
Off-label percutaneous pmVSD closure is a well-established procedure with promising results. Yet, interventionists are still searching for the ideal device.
Between June 2018 and March 2019, 20 patients with hemodynamically significant but restrictive-type pmVSD underwent an attempted transcatheter closure using the new KONAR-MF™. All implantations were performed retrogradely under general anesthesia, transoesophageal echocardiography, and fluoroscopic guidance. Prospective follow-up using transthoracic echocardiography and electrocardiogram was done until August 2019.
The median age was 6.4 years (8 months to 43.4 years), and the median body weight was 17.3 (9-74) kg. The mean defect size on the left ventricular aspect was 11.7 ± 2.8 mm. All devices were successfully and rapidly implanted. One device embolized in the pulmonary artery, 24 hr after implantation and was percutaneously retrieved with no complication. Over a mean follow-up period of 8.2 ± 3.0 months, complete closure was achieved in 84.2% of patients. One new onset of mild aortic regurgitation was detected before discharge and remained stable. Tricuspid valve regurgitation, complete heart block, major complication, and death were not observed.
Transcatheter pmVSD closure using the KONAR-MF™ can be successfully performed in adult and pediatric patients. It is a safe and promising device, designed to provide high conformability to septal defects with a lower risk of heart block. Retrograde implantation allows procedural flexibility, efficient deliverability, and control of valvular interferences.
评估使用新型KONAR-MF™室间隔缺损封堵器经导管封堵膜周部室间隔缺损(pmVSD)的安全性、有效性及中期结果。
非标签经皮pmVSD封堵术是一种成熟的手术,效果良好。然而,介入医生仍在寻找理想的器械。
2018年6月至2019年3月期间,20例血流动力学显著但为限制型pmVSD患者尝试使用新型KONAR-MF™进行经导管封堵。所有植入均在全身麻醉、经食管超声心动图和荧光透视引导下逆行进行。使用经胸超声心动图和心电图进行前瞻性随访至2019年8月。
中位年龄为6.4岁(8个月至43.4岁),中位体重为17.3(9 - 74)kg。左心室面平均缺损大小为11.7±2.8mm。所有器械均成功且迅速植入。一枚器械在植入后24小时栓塞于肺动脉,经皮取出,无并发症。平均随访8.2±3.0个月,84.2%的患者实现完全封堵。出院前检测到1例新发轻度主动脉瓣反流,且保持稳定。未观察到三尖瓣反流、完全性心脏传导阻滞、主要并发症及死亡。
使用KONAR-MF™经导管封堵pmVSD在成人和儿童患者中均可成功进行。它是一种安全且有前景的器械,设计用于对室间隔缺损具有高度贴合性,且心脏传导阻滞风险较低。逆行植入允许手术具有灵活性、高效输送性及对瓣膜干扰的可控性。