A Novel Extracorporeal Continuous-Flow Ventricular Assist System for Patients With Advanced Heart Failureã- Initial Clinical Experience.
Circ J
; 84(7): 1090-1096, 2020 06 25.
Article
in En
| MEDLINE
| ID: mdl-32461539
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.MethodsâandâResults:
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.Key words
Full text:
1
Database:
MEDLINE
Main subject:
Extracorporeal Membrane Oxygenation
/
Heart-Assist Devices
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Ventricular Function, Left
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Ventricular Function, Right
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Prosthesis Implantation
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Heart Failure
Type of study:
Diagnostic_studies
/
Prognostic_studies
Limits:
Adult
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Female
/
Humans
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Male
/
Middle aged
Language:
En
Year:
2020
Type:
Article