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

S. Pahwa, G. Lee, V. Tchantchaleishvili, M. Weber, V. Khullar, R. Daly, E. Schumer, A. Rosenbaum, S. Schettle, A. Behfar, J. Stulak

Research output: Contribution to journalArticlepeer-review

Abstract

PURPOSE: 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. METHODS: 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). CONCLUSION: 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.

Original languageEnglish (US)
Pages (from-to)S439-S440
JournalJournal of Heart and Lung Transplantation
Volume39
Issue number4
DOIs
StatePublished - Apr 1 2020

ASJC Scopus subject areas

  • Surgery
  • Pulmonary and Respiratory Medicine
  • Cardiology and Cardiovascular Medicine
  • Transplantation

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