Novel catheter treatment of structural heart and valve disease

$2,748,980ZIAFY2021HLNIH

National Heart, Lung, And Blood Institute

Investigators

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Abstract

We have begun multicenter testing of mitral cerclage annuloplasty to treat secondary mitral regurgitation in patients in the USA. Preliminary findings suggest substantial improvement in functional status, symptoms, and chamber volumes out of proportion to mitral regurgitation. We are shifting clinical protocols to evaluate the impact of cerclage on cardiomyopathy. We have continued preclinical development with an industry partner for our transauricular intrapericardial tricuspid annuloplasty (TRAIPTA) technique and device to treat secondary tricuspid regurgitation. We expect to begin USA early feasibility testing next year. We completed enrollment and reporting of a multicenter early feasibility study of Bioprosthetic or native Aortic Scallop Intentional Laceration to prevent Iatrogenic Coronary Artery obstruction after TAVR (BASILICA). We are leading education and proctorship, directly and in industry partnership, for this technique which has been applied to hundreds of patients worldwide. We are working to develop a purpose-built device. We completed enrollment and reporting of a multicenter early feasibility study of intentional Laceration of the Anterior Mitral leaflet to Prevent left ventricular Outflow ObstructioN (LAMPOON) after transcatheter mitral valve replacement. We have led education efforts. The technique has been applied to hundreds of patients worldwide. We continue development of a purpose-built transcatheter end-to-side anastomosis and endograft for extra-anatomic bypass of an orphan pediatric application, a transcatheter Glenn Shunt. We have performed Good Laboratory Practice experiments towards a first-in-human clinical protocol in collaboration with an industry partner (Transmural Systems). We continue education and proctorship for transcaval access, which has been performed across the globe in over 1000 patients to date. We are developing novel techniques and devices to remodel the ventricle using mechanical (MIRTH and SCIMITAR), electrical (ablation), and chemoablation techniques (CEVICHE), and transcatheter mitral valve replacement.

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