A Novel Extracorporeal Continuous-Flow Ventricular Assist System for Patients With Advanced Heart Failure　― Initial Clinical Experience

• Published in: Circulation Journal 2020/06/25, Vol.84(7), pp.1090-1096
• Main Authors: Seguchi, Osamu, Fujita, Tomoyuki, Kitahata, Nana, Iwasaki, Keiichiro, Kuroda, Kensuke, Nakajima, Seiko, Watanabe, Takuya, Yanase, Masanobu, Fukushima, Satsuki, Tsukiya, Tomonori, Katagiri, Nobumasa, Mizuno, Toshihide, Takewa, Yoshiaki, Hamasaki, Toshimitsu, Onda, Kaori, Hayashi, Teruyuki, Yamamoto, Haruko, Tatsumi, Eisuke, Kobayashi, Junjiro, Fukushima, Norihide
• Format: Article
• Language: English
• Subjects: Adult; Advanced heart failure; Bridge-to-decision; Bridge-to-transplantation; Extracorporeal Membrane Oxygenation - adverse effects; Extracorporeal Membrane Oxygenation - instrumentation; Extracorporeal Membrane Oxygenation - mortality; Female; Heart Failure - diagnosis; Heart Failure - mortality; Heart Failure - physiopathology; Heart Failure - therapy; Heart Transplantation; Heart-Assist Devices; Humans; Male; Mechanical circulatory support; Middle Aged; Prosthesis Design; Prosthesis Implantation - adverse effects; Prosthesis Implantation - instrumentation; Prosthesis Implantation - mortality; Recovery of Function; Time Factors; Treatment Outcome; Ventricular assist device; Ventricular Function, Left; Ventricular Function, Right
• ISSN: 1346-9843; 1347-4820; 1347-4820
• DOI: 10.1253/circj.CJ-19-1122

Background:Bridge-to-decision (BTD) devices providing temporary mechanical circulatory support should be introduced to patients with advanced heart failure. This study evaluated the effectiveness and safety of a BTD device comprising an innovative extracorporeal continuous-flow temporary ventricular assist device (VAD) driven by a novel hydrodynamically levitated centrifugal flow blood pump.Methods and Results:Nine patients, comprising 3 with dilated cardiomyopathy, 3 with fulminant myocarditis, and 3 with ischemic heart disease, and 6 males, whose mean age was 47.7±8.1 years, were enrolled into the study. Six patients had Interagency Registry for Mechanically Assisted Circulatory Support profile 1, and 3 were profile 2. The primary endpoint was a composite of survival free from device-related serious adverse events and complications during circulatory support. Eight patients received left ventricular support, of whom 3 received concomitant right ventricular support using extracorporeal membrane oxygenation circuits, as a consequence of severe respiratory failure. One patient with fulminant myocarditis received biventricular support using the novel VAD system. After 19.0±13.5 days, 3 patients were weaned from circulatory support, because their native cardiac function recovered, and 6 patients required conversion to a durable device as a bridge-to-transplantation. One patient had non-disabling ischemic stroke episodes, and no patients died.Conclusions:This novel extracorporeal VAD system with a hydrodynamically levitated centrifugal pump can safely and successfully bridge patients with advanced heart failure to subsequent therapeutic stages.