Jay H Traverse, M.D., FSCAI
,
Minneapolis Heart Institute Foundation at Abbott Northwestern Hospital, Minneapolis, MN
Timothy D. Henry, M.D., MSCAI
,
The Christ Hospital Health Network, Covington, KY
Nabil Dib, M.D., MSc, FACC
,
Mercy Gilbert Medical Center, Gilbert, AZ
Amit N. Patel, M.D., MS
,
University of Utah, Bradenton, UT
Gary L. Schaer, M.D.
,
Rush University Medical Center, Chicago, IL
Carl J Pepine, M.D.
,
University of Florida College of Medicine, Gainesville, FL
Adam M Kinsey, PhD
,
Ventrix, San Diego, CA
Paul Chamberlin, MD
,
Ventrix, San Diego, CA
Karen L Christman, PhD, FACC
,
University of California, San Diego, San Diego, CA
Background:
Injectable biomaterials have shown promise as a strategy to promote endogenous cardiac repair, but limited materials have advanced into clinical trials. In this first-in-man study at 6 clinical sites, we examined the effects of VentriGel (Ventrix, Inc.), an injectable scaffold derived from decellularized porcine myocardial extracellular matrix (ECM), in patients who had a STEMI in the last 3 years.
Methods:
The safety and feasibility of percutaneous transendocardial delivery of VentriGel (open label) was evaluated in 15 patients with their first STEMI treated by PCI who had moderate LV dysfunction (25% <LVEF < 45%). VentriGel was delivered by 18 injections (0.3 ml) via a MyoStar catheter after NOGA mapping. The primary objective was safety within 6 months of injection. Secondary endpoints included 6 MWT, MLWHFQ, NYHA Class, BNP, and evaluation of cardiac structure and function by MRI at baseline, 3 and 6 months post-injection.
Results:
VentriGel was well tolerated with no significant events related to product. There were significant improvements in 6MWT and NYHA class post-delivery (Fig. 1A,B) and LV volumes were either maintained or improved in 11 out of 14 patients (by MRI) at 6 months, especially patients treated >1 year post-MI (Fig. 1C,D).
Conclusions:
This study provides support for the safety and feasibility of treating ischemic patients with LV dysfunction with VentriGel, a biomaterial designed for cardiac repair, and supports the development of a larger Phase 2 clinical trial.
