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Multicenter Study
. 2020 Nov;8(11):892-902.
doi: 10.1016/j.jchf.2020.09.004.

Hemocompatibility-Related Adverse Events and Survival on Venoarterial Extracorporeal Life Support: An ELSO Registry Analysis

Mabel Chung  1 , Fausto R Cabezas  2 , Jose I Nunez  2 , Kevin F Kennedy  3 , Katelyn Rick  2 , Peter Rycus  4 , Mandeep R Mehra  5 , A Reshad Garan  2 , Robb D Kociol  2 , E Wilson Grandin  6
Affiliations
Multicenter Study

Hemocompatibility-Related Adverse Events and Survival on Venoarterial Extracorporeal Life Support: An ELSO Registry Analysis

Mabel Chung et al. JACC Heart Fail. 2020 Nov.

Abstract

Objectives: This study sought to determine the frequency, incidence rates over time, association with mortality, and potential risk factors for hemocompatibility-related adverse events (HRAEs) occurring during venoarterial-extracorporeal life support (VA-ECLS).

Background: HRAEs are common complications of VA-ECLS. Studies examining relevant clinical predictors and the association of HRAEs with survival are limited by small sample size and single-center setting.

Methods: We queried adult patients supported with VA-ECLS from 2010 to 2017 in the Extracorporeal Life Support Organization database to assess the impact of HRAEs on in-hospital mortality.

Results: Among 11,984 adults meeting study inclusion, 8,457 HRAEs occurred; 62.1% were bleeding events. The HRAE rate decreased significantly over the study period (p trend <0.001), but rates of medical bleeding and ischemic stroke remained stable. HRAEs had a cumulative association with mortality in adjusted analysis: 1 event, odds ratio (OR) of 1.43; 2 events, OR of 1.86; ≥3 events, OR of 3.27 (p < 0.001 for all). HRAEs most strongly associated with mortality were medical bleeding, including intracranial (OR: 7.71), pulmonary (OR: 3.08), and gastrointestinal (OR: 1.95) hemorrhage and ischemic stroke (OR: 2.31); p < 0.001 for all. Risk factors included the following: for bleeding: older age, lower pH, and female sex; for thrombosis: younger age, male sex, Asian race, and non-polymethylpentene oxygenator; and for both: time on ECLS, central cannulation, and renal failure.

Conclusions: Although decreasing, HRAEs remain common during VA-ECLS and have a cumulative association with survival. Bleeding events are twice as common as thrombotic events, with a hierarchy of HRAEs influencing survival. Differential risk factors for bleeding and thrombotic complications exist and raise the possibility of a tailored approach to ECLS management.

Keywords: bleeding; hemocompatibility; survival; thrombosis; venoarterial extracorporeal life support.

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Conflict of interest statement

Author Relationship With Industry Dr. Chung is funded by the National Institutes of Health (T32-GM007592) as well as by Medtronic outside the submitted work. Drs. Cabezas and Grandin have received an Extracorporeal Life Support Organization Research Grant. Dr. Mehra has received consulting income from Abbott, Medtronic, Janssen, Bayer, Portola, FineHeart, NupulseCV, Leviticus, Mesoblast, and Triple Gene. Dr. Garan is an unpaid consultant to Abiomed. Dr. Kociol is employed by Boehringer Ingelheim. Dr. Grandin has received an Extracorporeal Life Support Organization Research Grant. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

Figures

FIGURE 1
FIGURE 1. Consort Diagram of Patient Selection for Primary Analysis
Flow chart of inclusion and exclusion criteria. VA-ECLS = venoarterial–extracorporeal life support.
FIGURE 2
FIGURE 2. Frequency of HRAE Categories During VA-ECLS
(A) Proportion of HRAEs comprising any bleeding or thrombotic events. (B) Frequency of specific HRAEs. HRAE = hemocompatibility-related adverse event; Oxy = oxygenator; VA-ECLS = venoarterial–extracorporeal life support.
FIGURE 3
FIGURE 3. Temporal Trends in HRAEs During VA-ECLS (2010-2017)
Rates of bleeding and thrombotic events per 100 h of ECLS support and VA-ECLS case volume by year. Depicted rates are for all bleeding events (red dot), all thrombotic events (blue square), medical bleeding (red star), ischemic stroke (blue hash), and case volume (purple bars). *2017 is a partial year. CI = confidence interval; OR = odds ratio; other abbreviations as in Figure 2.
FIGURE 4
FIGURE 4. Risk Factors for Bleeding During VA-ECLS
(A) Factors associated with any bleeding event, including cannulation and surgical site, tamponade, pulmonary and gastrointestinal bleeding, and hemorrhagic stroke. (B) Odds ratios for medical bleeding, including pulmonary and gastrointestinal bleeding and hemorrhagic stroke. *The odds ratios for bleeding events were generated with White race as the reference. PMP = polymethylpentene; other abbreviations as in Figure 2 and 3.
FIGURE 5
FIGURE 5. Risk Factors for Thrombosis During VA-ECLS
(A) Factors associated with any thrombotic event, including clots in the circuit, hemolysis, oxygenator/pump failure, and ischemic stroke. (B) Odds ratios for ischemic stroke. *The odds ratios for thrombotic events were generated with White race as the reference. Abbreviations as in Figures 2 to 4.
CENTRAL ILLUSTRATION
CENTRAL ILLUSTRATION. Association of HemocompatibiLity-Related Adverse Events During Venoarterial-Extracorporeal Life Support With In-Hospital Mortality
Association of hemocompatibility-related adverse events with in-hospital mortality adjusted for available covariates. CI = confidence interval..
See this image and copyright information in PMC

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