Novel catheter treatment of structural heart and valve disease

National Heart, Lung, And Blood Institute

Investigators

Linked publications & trials

Abstract

We have performed multicenter testing of mitral cerclage ventriculoplasty to treat heart failure syndromes, with or without mitral regurgitation, in patients in the USA. Initial findings suggest substantial improvement in functional status and symptoms, and stabilization of chamber volumes out of proportion to mitral regurgitation. Cerclage showed basal ventriculoplasty to be feasible and to improve symptoms, but heart block was observed in about one-third of human subjects. We developed an improved transcatheter ventriculoplasty in the MIRTH (Myocardial Interstitial Reinforcement using an endovenous teTHer) procedure, which entails implanting a drawstring-like tension device circumferentially WITHIN the heart muscle, in order to shrink dilated hearts and improve their pumping efficiency. MIRTH implantation is guided by a novel electrocardiographic depth navigation technique (EDEN). Non-clinical studies in model cardiomyopathy show a reduction in ventricular volumes and improved left ventricular elastance. MIRTH has been performed on a patient by clinical partners on a compassionate basis. 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 have developed a purpose-built device called TELLTALE designed for electrosurgical laceration of aortic leaflets in the BASILICA procedure. A license application was filed with FDA and clinical evaluation is expected to begin in 2022Q4. 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 are developing other novel procedures and devices to address important unmet clinical needs. Other techniques developed in the laboratory continue to be adopted worldwide, including transcaval access, LAMPOON mitral leaflet laceration, and BASILICA aortic leaflet laceration.