Elsevier

JACC: Heart Failure

Volume 10, Issue 12, December 2022, Pages 948-959
JACC: Heart Failure

Clinical Research
Prediction of Survival After Implantation of a Fully Magnetically Levitated Left Ventricular Assist Device

https://doi.org/10.1016/j.jchf.2022.08.002Get rights and content
Under a Creative Commons license
open access

Abstract

Background

Clinical trials inform on average efficacy, but individualized risk assessments for outcome prediction are important in guiding treatment implementation.

Objectives

The authors developed and validated a patient-specific risk score to predict survival at 1 and 2 years after HeartMate 3 (HM3) left ventricular assist device (LVAD) implantation.

Methods

The MOMENTUM 3 (Multicenter Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Support Therapy with HeartMate 3) trial includes 2,200 HM3 LVAD patients in the pivotal trial and Continued Access Protocol study (2014-2018). The authors randomly assigned all patients to a derivation cohort (n = 1,540) or validation cohort (n = 660). Univariate mortality predictors were screened for potential model inclusion, stepwise selection was used to build the multivariable Cox proportional hazards regression model, and performance (discrimination and calibration) was evaluated.

Results

Age, prior cardiac surgery (coronary artery bypass grafting [CABG] or valve procedure), lower serum sodium, higher blood urea nitrogen (BUN), small left ventricular size, and right atrial pressure-to-pulmonary capillary wedge pressure (RAP/PCWP) ratio >0.6 were significant risk factors for mortality. Receiver-operating characteristic (ROC) analysis in the validation cohort demonstrated an area under the curve (AUC) of 0.76 (95% CI: 0.70-0.81) at 1 year and 0.71 (95% CI: 0.66-0.77) at 2 years. Calibration between predicted and observed survival of the risk quintiles was high, with Pearson correlation coefficients of 0.986 and 0.994 at 1 and 2 years, respectively. Patients were successfully stratified into tertiles with higher-than-average, average, and lower-than-average survival, and observed mortality risk increased by 2-fold from one tertile to the next.

Conclusions

A practical, easy-to-use HM3 Survival Risk Score with 6 components was developed to accurately predict 1- and 2-year survival after HM3 LVAD implantation. The survival risk score can be used to provide individual survival estimates to facilitate shared decision making when considering HM3 LVAD therapy. (MOMENTUM 3 Trial Portfolio; NCT02224755, NCT02892955)

Key Words

HeartMate 3
LVAD
prediction
risk score
shared decision making
survival

Abbreviations and Acronyms

AUC
area under the curve
BUN
blood urea nitrogen
CABG
coronary artery bypass grafting
HM3
HeartMate 3
HM3RS
HeartMate 3 Survival Risk Score
LVAD
left ventricular assist device
LVEDD
left ventricular end-diastolic dimension
PCWP
pulmonary capillary wedge pressure
RAP
right atrial pressure
ROC
receiver-operating characteristic

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The authors attest they are in compliance with human studies committees and animal welfare regulations of the authors’ institutions and Food and Drug Administration guidelines, including patient consent where appropriate. For more information, visit the Author Center.

Drs Mehra and Nayak contributed equally to this paper.