23 Nov New TAVR System For Non-Calcified Aortic Valve Regurgitation
Dr. Chunsheng Wang
MedicalResearch.com Interview with:
Chunsheng Wang, MD
Department of Cardiovascular Surgery, Shanghai Cardiovascular Institution
and Zhongshan Hospital
Fudan University, Shanghai, China
Medical Research: What is the background for this study? What are the main findings?
Dr. Wang: Transcatheter aortic valve replacement (TAVR) has been widely used in high-risk patients for surgical aortic valve replacement. However, the majority of the TAVR devices were designed for aortic valve stenosis with significant valve calcification. For most of these devices, predominant aortic regurgitation remained to be a technological challenge because of questionable anchoring, which can result in a high incidence of valve migration and paravalvular leak. Consequently, the guidelines from the United States and the Europe suggest that candidates with predominant aortic regurgitation (>grade 3+) or noncalcified valve should not undergo TAVR. Patients with predominant aortic regurgitation who are at prohibitive risk for surgery need an alternative treatment. A new generation of transcatheter aortic valve devices with secure anchoring is needed.
Six patients with native aortic regurgitation without significant valve calcification (age, 61 to 83 years; mean age, 75.50±8.14 years) underwent transapical implantation of the J-Valve prosthesis (JieCheng Medical Technology Co.,Ltd., Suzhou, China), a self-expandable porcine valve. Implantations were successful in all patients. During the follow-up period (from 31 days to 186 days, mean follow-up was 110.00±77.944 days), only 1 patient had trivial prosthetic valve regurgitation, and none of these patients had paravalvular leak of more than mild grade. There were no major postoperative complications or mortality during the follow-up. Our study demonstrated the feasibility of transapical implantation of the J-Valve system in high-risk patients with predominant aortic regurgitation.
Medical Research: What should clinicians and patients take away from your report?
Dr. Wang Our study demonstrated the feasibility of transapical implantation of the J-Valve system in high-risk patients with predominant aortic regurgitation. Procedural and early results of the study on the J-Valve system performance are promising. We are confident that the safety and reliability of its application in predominant aortic regurgitation would be confirmed in further research with a larger patient population and longer follow-up duration.
Medical Research: What recommendations do you have for future research as a result of this study?
Dr. Wang: Novel devices have been developed for treatment of pure aortic regurgitation with non-calcified valve. The TAVI procedure for pure aortic regurgitation is quite different from that for aortic stenosis with significant calcified valve. How to measure the annulus diameter accurately is the key to prevent the para-valvular leakage. The variability of the annulus diameter during the cardiac cycle could be a challenge for the precise measurement. And the annulus diameter of regurgitant valve might be bigger than that of the stenotic valve. An appropriate oversizing is vital to prevent para-valvular leakage and conduction disturbance. Bigger prosthesis(≥29mm) in delivery system with limited size of sheath could be a technological challenge but also a selling point for manufacturer.
As the development of new generation TAVI devices, the time for break the limit of TAVI for pure aortic regurgitation is coming.
Citation:
J Am Coll Cardiol Intv. Published online November 18, 2015.
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Chunsheng Wang, MD (2015). New TAVR System For Non-Calcified Aortic Regurgitation
Last Updated on November 23, 2015 by Marie Benz MD FAAD