Functional Outcomes Not Significantly Impacted by Hemocompatibility-Related Adverse Event Burden among Different Devices

Abstract

Landmark work has demonstrated that the hemocompatibility-related adverse event (HRAE) burden is significantly lower with the newest centrifugal flow pump; however, no study has specifically examined this HRAE burden on the prior commercially available pumps and the impact on functional outcomes. We performed a retrospective analysis of HRAE (non-surgical bleeding, thrombo-embolic event, pump thrombosis, or neurological event) burden in patients following surgical implantation of Heart-Mate II (HMII) or Heart-Ware (HW) devices through 1 year of clinical follow-up. An HRAE were categorized by the type and severity of an adverse event and then assigned a net Hemocompatibility Score (HCS) of 0 through 4 for no HRAE through life-ending or disabling HRAE. Statistical analysis included comparison of net HCS using proportional regression, as well as impact on functional outcomes [NYHA class, dyspnea score, 6-minute walk, and peak venous oxygen consumption (VO2)] RESULTS: The study cohort included a total of 331 patients, with 268 patients (81%) in the HMII group and 63 patients (19%) in HW group. The overall median age was 62.2 years; patients receiving HMII were older (median 63.5 versus 58.1years, p<0.001). Net HCS per patient in the HMII group was 0.7 (±1.4), reported as mean (± standard deviation). This was similar to the net HCS per patient of 0.5 (±1.2) in the HW group (p=0.36). A scatter-plot analysis demonstrates no significant impact on functional outcomes between the comparison groups for NYHA class (p=0.06), 6-minute walk distance (p=0.54), Borg dyspnea rating (p=0.12) or peak VO2 (p=0.83) (Figure 1). Burden of HRAE does not adversely affect measures of functional capacity after device implantation. Furthermore, this did not differ with the use of prior commercially-available devices. These findings indicate that overall functional quality of life may not be significantly impacted by burden of HRAE regardless of pump technology.