In high-risk patients with predominant aortic regurgitation, transapical implantation of a new self-expandable porcine transcatheter aortic valve replacement system was feasible, according to early results published in JACC: Cardiovascular Interventions.
The J-Valve system (JieCheng Medical Technology Co., Ltd.) features a two-piece structure that includes a three-prong clasper and a support frame. According to the researchers, implantation is performed in two stages to allow for precise positioning and secure anchoring of the prosthesis by “clamping the native valve leaflets between it and the support frame.”
Lai Wei, MD, from the department of cardiovascular surgery at Shanghai Cardiovascular Institution and Zhongshan Hospital, Fundan University, Shanghai, China, and colleagues reported early results of transapical implantations of the J-Valve system.
The J-Valve system was implanted via transapical access in six patients with native aortic regurgitation without significant valve calcification who were considered at high or prohibitive risk for surgical valve replacement. The patients’ mean age was 75 years, mean logistic EuroSCORE was 29.32% and 66.7% were men.
Implantation was successful in all six patients. During a mean follow-up of 110 days, no patient experienced more than mild paravalvular leak and no major postoperative complications or deaths were observed, according to the results.
In other results, one patient had kidney injury after the procedure, but recovered without need for dialysis; one patient experienced first-degree atrioventricular block; one patient developed minor prosthetic valve regurgitation; and three patients developed new-onset complete left bundle branch block. After implantation, all patients had NYHA class I or II HF. There was no evidence of neurological complications such as stroke or transient ischemic attack and no permanent pacemakers were required after implantation.
Mean length of stay in the ICU was 2.17 days and mean postoperative hospital stay was 6 days.
The J-Valve was available in four sizes during this study: 21 mm, 23 mm, 25 mm and 27 mm. Currently, the largest prosthesis available is 27 mm, but a 29-mm valve is in development.
The researchers concluded that “procedural and early results of the study on the J-Valve system performance are promising.” They noted that “further research with a larger patient population and longer follow-up duration are scheduled to confirm the safety and reliability of its application in predominant aortic regurgitation.” – by Tracey Romero
researchers report no relevant financial disclosures.