Abstract
Introduction: Prior studies have shown that females have worse 3-month survival post-LVAD. Currently used prognostic scores including the Heartmate II Risk Score (HMRS), were developed in >75% male cohorts, and may not account for the increased residual risk in females. Hypothesis: A sex-specific risk score will predict post-LVAD mortality in females, and perform better than HMRS. Methods: Adult CF-LVAD patients from the ISHLT Mechanically Assisted Circulatory Support (IMACS) registry (Implant years: Jan 2013 - Sep 2017, age: 56 ± 13 yrs, 21% female, 36% centrifugal pumps) were randomly divided into derivation (DC, n=9113, 21% female) and validation cohorts (VC, n=6074, 21% female). Primary outcome of interest was 3-month mortality. IMACS risk score (IMACS-RS) was developed in the DC, from pre-operative candidate predictors selected using Akaike Information Criterion, or significant sex*variable interaction. Results: There were 1,466 deaths (9.7%) within 3 months after implant. In the DC, age, cardiogenic shock at implant, Body Mass Index, Blood Urea Nitrogen, bilirubin, hemoglobin, albumin, platelet count, LV End Diastolic Diameter, Tricuspid Regurgitation, dialysis and major infection pre-implant were retained as significant predictors of 3-month mortality. There was a significant ischemic HF*sex and platelet count*sex interaction. For each quartile increase in IMACS-RS, females had 93% increased odds (p<0.0001), and males had 86% increased odds (p<0.0001) of 3-month mortality. IMACS-RS represented a significant improvement over HMRS (p<0.01 for improvement in AUC) and provided excellent risk calibration in both sexes (no significant difference between observed and predicted risk). Removal of sex-specific interaction terms resulted in significant loss of model fit. Conclusions: A sex-specific risk score provides excellent risk prediction in LVAD patients. Future prognostic studies in advanced HF should present sex-specific secondary outcomes.
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