Outcomes of a multicenter trial of the Levitronix CentriMag ventricular assist system for short-term circulatory support.
OBJECTIVE
The Levitronix CentriMag (Levitronix LLC, Waltham, Mass) ventricular assist system is designed for temporary left, right, or biventricular support. Advantages include ease of use, excellent reliability, and low thrombosis risk,. which may allow wider application of short-term support and improved outcomes in patients with cardiogenic shock. This multi-institutional study evaluated safety, effectiveness, and outcomes of the CentriMag in patients with cardiogenic shock.


METHODS
Thirty-eight patients were supported at 7 centers. Patients included 12 after cardiotomy, 14 after myocardial infarction, and 12 with right ventricular failure after implantable left ventricular assist device placement. Devices were implanted in left (n = 8), right (n = 12), or biventricular (n = 18) configuration. Support was continued until recovery, transplantation, or implantation of long-term ventricular assist device.


RESULTS
Mean support duration for the entire cohort (n = 38) was 13 days (1-60 days), with 47% of patients (18/38) surviving 30 days after device removal. Mean CentriMag biventricular support (n = 18) duration was 15 days (1-60 days), with 44% (8/18) surviving at 30 days. Mean CentriMag right ventricular support with a commercially available left ventricular assist device (n = 12) duration was 14 days (1-29 days), with 58% (7/12) surviving at 30 days. Complications included bleeding (21%), infection (5%), respiratory failure (3%), hemolysis (5%), and neurologic dysfunction (11%). There were no CentriMag or pump failures.


CONCLUSIONS
In this preliminary study, the CentriMag provided short-term support for patients with cardiogenic shock with a low incidence of device-related complications and no device failures.
John
Ranjit
R
University of Minnesota Medical Center, Minneapolis, Minn, USA. johnx008@umn.edu
Long
James W
JW
Massey
H Todd
HT
Griffith
Bartley P
BP
Sun
Benjamin C
BC
Tector
Alfred J
AJ
Frazier
O Howard
OH
Joyce
Lyle D
LD
D000328:Adult; D000368:Aged; D005260:Female; D006353:Heart-Assist Devices / Q000009:adverse effects; D006439:Hemodynamics; D006461:Hemolysis; D006801:Humans; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D011474:Prosthesis Design; D020127:Recovery of Function; D012770:Shock, Cardiogenic / Q000401:mortality / Q000503:physiopathology / Q000628:therapy*; D013923:Thromboembolism / Q000209:etiology; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States; D016277:Ventricular Function, Left; D016278:Ventricular Function, Right