A novel extracorporeal continuous-flow ventricular assist system for patients with advanced heart failure: Initial clinical experience

Osamu Seguchi, Tomoyuki Fujita, Nana Kitahata, Keiichiro Iwasaki, Kensuke Kuroda, Seiko Nakajima, Takuya Watanabe, Masanobu Yanase, Satsuki Fukushima, Tomonori Tsukiya, Nobumasa Katagiri, Toshihide Mizuno, Yoshiaki Takewa, Toshimitsu Hamasaki, Kaori Onda, Teruyuki Hayashi, Haruko Yamamoto, Eisuke Tatsumi, Junjiro Kobayashi, Norihide Fukushima

Research output: Contribution to journalArticlepeer-review

Abstract

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.

Original languageEnglish
Pages (from-to)1090-1096
Number of pages7
JournalCirculation Journal
Volume84
Issue number7
DOIs
Publication statusPublished - 25-06-2020
Externally publishedYes

All Science Journal Classification (ASJC) codes

  • Cardiology and Cardiovascular Medicine

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