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

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

Research output: Contribution to journalArticle

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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    Pahwa, S., Lee, G., Tchantchaleishvili, V., Weber, M., Khullar, V., Daly, R. C., Schumer, E., Rosenbaum, A., Schettle, S., Behfar, A., & Stulak, J. (2020). Functional Outcomes Not Significantly Impacted by Hemocompatibility-Related Adverse Event Burden among Different Devices. Journal of Heart and Lung Transplantation, 39(4), S439-S440. https://doi.org/10.1016/j.healun.2020.01.246