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

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).

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.

On June 28 and 29, 2022, 4 patients were enrolled and underwent high-risk PCI with ModulHeart implanted via transfemoral approach. All 4 patients achieved procedural success. The mean delivery time was 8 minutes, the mean support time was 49 minutes, and the mean pump removal time was 7 minutes. The mean pressure gradient across the pump was 5 ± 2 mm Hg. Under ModulHeart support, cardiac index increased by 25%, central venous pressure decreased by 37%, and left ventricular end-diastolic pressure decreased by 78%. Urine output increased by ∼9-fold after 15 minutes of support. No device malfunction or procedural or device-related adverse events occurred. There was no evidence of pump thrombosis. All 4 patients were alive at 30 days.

This first-in-human study demonstrated the feasibility and safety of cardiorenal support with ModulHeart among patients undergoing high-risk PCI. ModulHeart demonstrated significant improvement in cardiac output, left ventricular end-diastolic pressure, and urine output. Future studies are planned to assess outcomes associated with ModulHeart support in patients with heart failure.