Bleiweis et al. summarize in this single center retrospective study their experiences with the Berlin Heart EXCOR® VAD in 9 patients with single ventricle physiology.
The patients had a median weight of 4.0kg and a median length of 64 days of VAD support. 83% of patients bridged to transplant survived.
The authors come to the following conclusion:
“Pulsatile para-corporeal VAD as a bridge-to-transplant is a feasible option in supporting the failing stage-one single ventricle.”
“This small cohort has shown promise in utilizing a pulsatile paracorporeal ventricular assist device to bridge-to-transplant with positive outcomes.”
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www.jtcvs.org/article/S0022-5223(20)32669-6/pdf
The use of EXCOR in patients with single ventricle physiology is not described in Berlin Heart's IFU of EXCOR sterile components. A separate labeling for EXCOR® Venous Cannula will be provided. This presentation describes data and investigator-initiated studies from centers who have decided to treat patients with single ventricle physiology using EXCOR.
The access to some or all shown products may be restricted by country-specific regulatory approvals. The use of EXCOR® VAD for adults, RVAD-support, Excor mobile and EXCOR® Active is not FDA-approved.