An Analysis of Post-Implant Severe Right Heart Failure in Real-World Use of the HeartWareTM HVADTM System in Destination Therapy

Abstract

Purpose Clinical trials of the HeartWare™ HVADTM System have demonstrated a low rate of post-implant severe right ventricular failure (RVF) requiring implantation of a right ventricular assist device (RVAD). In an analysis of the North American clinical trials of the HVAD System, including the ADVANCE BTT+CAP Trial (N=382), the ENDURANCE Trial (N=296), the ENDURANCE Supplemental Trial (N=308) and the Lateral Trial (N=144), RVADs were implanted in 2.7% of patients (31/1130) over 2 years of support. However, the overall percentage of patients in INTERMACS profile 1 at implant was only 4.2% and those with anticipated need for post-operative RVAD were excluded. We will present an analysis of severe RVF requiring an RVAD in the real-world post-approval study of the HVAD System when used in destination therapy patients (DT-PAS and Apogee International study). Methods The objective of this analysis is to examine the rate of RVAD use in the prospective DT PAS study (n=212) and the Apogee International study (n=46). At the time of presentation, we will have 258 patients with follow-up data through at least 6 months of support. Results Data is currently being collected from 50 centers in the US, EMEA, and Australia. Descriptive data and severe RVF data will be presented, and a comparison, accounting for baseline differences, to the HVAD clinical trials will be performed. Baseline parameters of the 258 patients includes mean age 58.3 years, with 15.4% INTERMACS profile 1 and 44.6% with ischemic etiology. Preliminary data from 212 patients in the US DT PAS cohort (with 16.3% INTERMACS 1) reveals an incidence of RVAD use of 6.1% over a mean time on support of 5 months. Data collection and analysis is ongoing. Conclusion Analyses of real-world use of the HVAD System reveals its increasing use in higher risk and more complex patients. Final data on RVAD use in 258 patients through 6 months will be available at the time of presentation.