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Multicenter Study
. 2022 Dec;10(12):948-959.
doi: 10.1016/j.jchf.2022.08.002. Epub 2022 Oct 12.

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

Mandeep R Mehra  1 , Aditi Nayak  2 , Alanna A Morris  2 , David E Lanfear  3 , Hassan Nemeh  3 , Sapna Desai  4 , Aditya Bansal  4 , Cesar Guerrero-Miranda  5 , Shelley Hall  5 , Joseph C Cleveland Jr  6 , Daniel J Goldstein  7 , Nir Uriel  8 , Leway Chen  9 , Stephen Bailey  10 , Anelechi Anyanwu  11 , Gerald Heatley  12 , Joyce Chuang  12 , Jerry D Estep  13
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Free article
Multicenter Study

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

Mandeep R Mehra et al. JACC Heart Fail. 2022 Dec.
Free article

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).

Keywords: HeartMate 3; LVAD; prediction; risk score; shared decision making; survival.

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Conflict of interest statement

Funding Support and Author Disclosures The MOMENTUM 3 trial portfolio (NCT02224755, NCT02892955) was funded by Abbott. Dr Mehra has received travel support and consulting fees, paid to Brigham and Women’s Hospital, from Abbott; fees for serving on a steering committee from Medtronic and Janssen (Johnson & Johnson); fees for serving on a data and safety monitoring board from Mesoblast; consulting fees from Natera, Paragonix, Moderna, the Baim Institute of Clinical Research, and Broadview Ventures; and fees for serving as a scientific board member from NuPulseCV, Leviticus, and FineHeart. Dr Morris has received research support from the National Heart, Lung, and Blood Institute, the Agency for Healthcare Research and Quality, the Woodruff Foundation, and the Association of Black Cardiologists; and served as a consultant for Acorai, Boehringer Ingelheim Lilly, Cytokinetics, and Ionis. Dr Lanfear has served as a consultant for Abbott Laboratories, Amgen, AstraZeneca, Cytokinetics, DCRI (Novartis), Illumina, Janssen, Martin Pharmaceuticals, Otsuka, and Vicardia; and participated in clinical research for Amgen, AstraZeneca, Bayer, Critical Diagnostics, Lilly, Janssen, and Somalogic. Dr Desai has received consulting fees from Abbott. Dr Bansal has served on the advisory board for Abbott, Abiomed, TandemLife, and VADovations; as a proctor for Abbott; and as a consultant for Abbott, Abiomed, and TandemLife. Dr Cesar Guerrero-Miranda has served as a consultant for Abbott. Dr Hall has served as a consultant or advisory board member for Abbott, Abiomed, Medtronic, CareDx, and Natera. Dr Cleveland has served on the clinical events committee for Abbott. Dr Goldstein has served on the medical advisory board for Abbott and as a consultant for Abbott and Abiomed. Dr Uriel has served on the medical advisory board for Livemetric and Levitcus. Dr Chen has served as a consultant for Abbott. Co-authors Heatley and Chuang are Abbott employees. Dr Estep has received consulting fees from Abbott and Medtronic paid to his institution. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

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