First-in-Human Experience With the ModulHeart Device for Mechanical Circulatory Support and Renal Perfusion.

ABSTRACT:

Background

ModulHeart (Puzzle Medical Devices Inc) is a modular device providing hemodynamic support through 3 endovascular pumps inserted in series and assembled in parallel into a self-expandable anchor implanted in the descending aorta. The current study evaluates the feasibility and safety of cardiorenal support with ModulHeart among patients undergoing high-risk percutaneous coronary intervention (PCI).

Methods

This study was a prospective, single-center, first-in-human study. The primary end point was procedural success, defined as successful delivery, function, and removal of the ModulHeart device. Secondary end points included pump hemodynamics, cardiac hemodynamics, and urine output.

Results

On June 28 and 29, 2022, 4 patients were enrolled and underwent high

SUBMITTER: Georges G 

PROVIDER: S-EPMC11307613 | biostudies-literature | 2022 Nov-Dec

REPOSITORIES: biostudies-literature