ORIGINAL CLINICAL SCIENCE
International experience using a durable, centrifugal-flow ventricular assist device for biventricular support

https://doi.org/10.1016/j.healun.2020.08.006Get rights and content

BACKGROUND

Heart transplantation is limited by the scarcity of suitable donors. Patients with advanced biventricular failure may require biventricular support to provide optimal cardiac output and end-organ perfusion. We highlight the outcomes of using the HeartWare HVAD System (HVAD) in a biventricular configuration.

METHODS

This retrospective study included patients implanted with HVAD as a biventricular assist device (BiVAD) between 2009 and 2017 at 12 participating centers. When used as a right ventricular assist device (VAD) (RVAD), the HVAD can be attached to the right ventricle (RV) or the right atrium (RA). Kaplan–Meier survival estimates were calculated comparing the 2 RVAD implant locations. Comparisons were also made between the timing of RVAD implantation (primary vs staged) on adverse event (AE) profiles and survival.

RESULTS

Among the 93 patients who were implanted with a HVAD BiVAD, Kaplan–Meier survivals at 1-year and 2-year were 56% and 47%, respectively. Survival was independent of the location of the HVAD RVAD implant or whether there was an interval between left VAD and RVAD implantation. The most common AEs were bleeding (35.5%), infection (25.8%), and respiratory failure (20.4%).

CONCLUSIONS

This study illustrated similar survival in patients receiving a primary or staged HVAD BiVAD implant at 1 year and 2 years. This study also established that the locations of the RVAD implant (RV or RA) result in similar AE profiles.

Section snippets

Methods

This retrospective, multicenter study sought to identify patients implanted with a HVAD BiVAD between 2009 and 2017 at 12 international centers. The use of the HVAD pump for right ventricular support is considered to be an off-label indication. Institutional ethics approval was obtained for the collation of anonymized data. Implantation of the HVAD pump for right heart support was either performed at the same time as the HVAD LVAD implantation, as a primary implant, or >24 hours post-HVAD LVAD

Results

A total of 93 patients were identified in this retrospective, multicenter study. Demographics are outlined in Table 1. The average age of this patient population was 47.4 ± 12.93 years (range: 18–75 years), with 75.3% being male. The majority of the patients were classified as either INTERMACS Profile 1 (34.5%) or Profile 2 (26.4%) at implantation. The etiologies of heart failure (HF) were idiopathic (47.8%), myocarditis (15.9%), and ischemic (14.5%). Within this patient population, 47.3% of

Discussion

Right ventricular failure after LVAD implantation is still relatively common in INTERMACS Profile 1 and 2 patients and is associated with higher morbidity and mortality. Despite the incidence of refractory right HF in this patient population, there continue to be limited therapeutic options available. When patients develop refractory right HF, they are typically treated with temporary extracorporeal support, extracorporeal displacement pumps, or a more durable device such as a TAH or BiVADs. In

Disclosure statement

A.R.S. is a consultant for Medtronic and Transmedics Inc. J.G. and M.O. are consultants for Medtronic and Abbott. C.S.H. is a consultant for Medtronic and has received honoraria from Abbott and Medtronic. D.Z. and J.D.S. are consultants for Medtronic and receive research grant support from Abbott. The remaining authors have no conflicts of interest to disclose.

The authors gratefully acknowledge the assistance of Vince Cannon, Alexandra Dedrick, and Kristie Wallace from Medtronic for support in

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