Hemocompatibility-Related Outcomes in the MOMENTUM 3 Trial at 6 Months: A Randomized Controlled Study of a Fully Magnetically Levitated Pump in Advanced Heart Failure

Nir Uriel; Paolo C Colombo; Joseph C Cleveland; James W Long; Christopher Salerno; Daniel J Goldstein; Chetan B Patel; Gregory A Ewald; Antone J Tatooles; Scott C Silvestry; Ranjit John; Christiano Caldeira; Valluvan Jeevanandam; Andrew J Boyle; Kartik S Sundareswaran; Poornima Sood; Mandeep R Mehra

doi:10.1161/CIRCULATIONAHA.117.028303

Hemocompatibility-Related Outcomes in the MOMENTUM 3 Trial at 6 Months: A Randomized Controlled Study of a Fully Magnetically Levitated Pump in Advanced Heart Failure

Circulation. 2017 May 23;135(21):2003-2012. doi: 10.1161/CIRCULATIONAHA.117.028303. Epub 2017 Apr 6.

Authors

Nir Uriel¹, Paolo C Colombo¹, Joseph C Cleveland¹, James W Long¹, Christopher Salerno¹, Daniel J Goldstein¹, Chetan B Patel¹, Gregory A Ewald¹, Antone J Tatooles¹, Scott C Silvestry¹, Ranjit John¹, Christiano Caldeira¹, Valluvan Jeevanandam¹, Andrew J Boyle¹, Kartik S Sundareswaran¹, Poornima Sood¹, Mandeep R Mehra²

Affiliations

¹ From University of Chicago School of Medicine and Medical Center, IL (N.U., V.J.); Columbia University College of Physicians and Surgeons and New York Presbyterian Hospital, New York, NY (P.C.C.); University of Colorado School of Medicine, Denver (J.C.C.); Integris Baptist Medical Center, Oklahoma City, OK (J.W.L.); St. Vincent Heart Center, Indianapolis, IN (C.S.); Montefiore Einstein Center for Heart and Vascular Care, Bronx, NY (D.J.G.); Duke Heart Center, Duke University, Durham, NC (C.B.P.); Washington University School of Medicine, St. Louis, MO (G.A.E.); Advocate Christ Medical Center, Chicago, IL (A.J.T.); Florida Hospital, Orlando (S.C.S.); University of Minnesota Medical Center, Minneapolis (R.J.); Tampa General Hospital, FL (C.C.); Thomas Jefferson University, Philadelphia, PA (A.J.B.); Abbott, Pleasanton, CA (K.S.S.); Abbott, Burlington, MA (P.S.); and Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston, MA (M.R.M.).
² From University of Chicago School of Medicine and Medical Center, IL (N.U., V.J.); Columbia University College of Physicians and Surgeons and New York Presbyterian Hospital, New York, NY (P.C.C.); University of Colorado School of Medicine, Denver (J.C.C.); Integris Baptist Medical Center, Oklahoma City, OK (J.W.L.); St. Vincent Heart Center, Indianapolis, IN (C.S.); Montefiore Einstein Center for Heart and Vascular Care, Bronx, NY (D.J.G.); Duke Heart Center, Duke University, Durham, NC (C.B.P.); Washington University School of Medicine, St. Louis, MO (G.A.E.); Advocate Christ Medical Center, Chicago, IL (A.J.T.); Florida Hospital, Orlando (S.C.S.); University of Minnesota Medical Center, Minneapolis (R.J.); Tampa General Hospital, FL (C.C.); Thomas Jefferson University, Philadelphia, PA (A.J.B.); Abbott, Pleasanton, CA (K.S.S.); Abbott, Burlington, MA (P.S.); and Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston, MA (M.R.M.). mmehra@bwh.harvard.edu.

PMID: 28385948
DOI: 10.1161/CIRCULATIONAHA.117.028303

Abstract

Background: The HeartMate 3 (HM3) Left Ventricular Assist System (LVAS) (Abbott) is a centrifugal, fully magnetically levitated, continuous-flow blood pump engineered to enhance hemocompatibility and reduce shear stress on blood components. The MOMENTUM 3 trial (Multicenter Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Support Therapy With HeartMate 3) compares the HM3 LVAS with the HeartMate II (HMII) LVAS (Abbott) in advanced heart failure refractory to medical management, irrespective of therapeutic intention (bridge to transplant versus destination therapy). This investigation reported its primary outcome in the short-term cohort (n=294; 6-month follow-up), demonstrating superiority of the HM3 for the trial primary end point (survival free of a disabling stroke or reoperation to replace the pump for malfunction), driven by a reduced need for reoperations. The aim of this analysis was to evaluate the aggregate of hemocompatibility-related clinical adverse events (HRAEs) between the 2 LVAS.

Methods: We conducted a secondary end point evaluation of HRAE (survival free of any nonsurgical bleeding, thromboembolic event, pump thrombosis, or neurological event) in the short-term cohort (as-treated cohort n=289) at 6 months. The net burden of HRAE was also assessed by using a previously described hemocompatibility score, which uses 4 escalating tiers of hierarchal severity to derive a total score for events encountered during the entire follow-up experience for each patient.

Results: In 289 patients in the as-treated group (151 the HM3 and 138 the HMII), survival free of any HRAE was achieved in 69% of the HM3 group and in 55% of the HMII group (hazard ratio, 0.62; confidence interval, 0.42-0.91; P=0.012). Using the hemocompatibility score, the HM3 group demonstrated less pump thrombosis requiring reoperation (0 versus 36 points, P<0.001) or medically managed pump thrombosis (0 versus 5 points, P=0.02), and fewer nondisabling strokes (6 versus 24 points, P=0.026) than the control HMII LVAS. The net hemocompatibility score in the HM3 in comparison with the HMII patients was 101 (0.67±1.50 points/patient) versus 137 (0.99±1.79 points/patient) (odds ratio, 0.64; confidence interval, 0.39-1.03; P=0.065).

Conclusions: In this secondary analysis of the MOMENTUM 3 trial, the HM3 LVAS demonstrated greater freedom from HRAEs in comparison with the HMII LVAS at 6 months.

Clinical trial registration: URL: http://clinicaltrials.gov. Unique identifier: NCT02224755.

Keywords: biocompatible materials; circulatory and respiratory physiological phenomena; heart failure; heart-assist devices; hemorrhage; thrombosis.

Publication types

Comparative Study
Multicenter Study
Randomized Controlled Trial

MeSH terms

Aged
Device Removal
Disease-Free Survival
Equipment Design
Equipment Failure
Female
Heart Failure / diagnosis
Heart Failure / physiopathology
Heart Failure / therapy*
Heart-Assist Devices* / adverse effects
Hemolysis
Humans
Kaplan-Meier Estimate
Magnets*
Male
Materials Testing
Middle Aged
Odds Ratio
Proportional Hazards Models
Prospective Studies
Risk Factors
Stress, Mechanical
Stroke / etiology
Thrombosis / etiology
Time Factors
Treatment Outcome
Ventricular Function, Left*

Associated data

ClinicalTrials.gov/NCT02224755