Novel catheter treatment of structural heart and valve disease

National Heart, Lung, And Blood Institute

Investigators

Linked publications & trials

Abstract

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 are working internally and with industry to develop purpose-built MIRTH and EDEN devices; testing is ongoing towards clinical testing in 2024-2025. With our partners at Emory University, we have developed a novel ventriculoplasty to slice the beating heart. The treatment is called SESAME. It treats left ventricular outflow tract obstruction in patients with a common congenital heart disease (hypertrophic cardiomyopathy); it creates space to implant mitral and sometimes aortic valves non-surgically; it may in the future help relieve excessively-stiff hearts causing heart failure with preserved left ventricular function (HFpEF). We have helped our partners apply SESAME to the compassionate care of patients with few good options. We are working to develop a purpose-built device to accomplish SESAME to disseminate the technology more widely. 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 are negotiating with FDA to begin USA early feasibility testing this year. We have developed a purpose-built device called TELLTALE designed for electrosurgical laceration of aortic leaflets in the BASILICA procedure. We are conducting/leading a multi-center clinical trial; enrollment has begun (NCT05666713). Our purpose-built transcatheter end-to-side anastomosis and endograft for extra-anatomic bypass of an "orphan" pediatric application, a transcatheter Glenn Shunt, is terminated because the field of pediatric surgery and intervention has evolved to undermine the commercial value of the device. We are adapting the technology towards a transcatheter pulmonary artery to aorta shunt ("Potts Shunt") for end-stage pulmonary hypertension in adults. 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.