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PUBLICATIONS AND PRESENTATIONS FROM THE MOMENTUM 3 TRIAL

The MOMENTUM 3 (Multicenter Study of MagLev™ Technology in Patients Undergoing Mechanical Circulatory Support Therapy with HeartMate 3™) investigational device exemption (IDE) clinical study was designed to evaluate the safety and effectiveness of HeartMate 3™ Left Ventricular Assist System (LVAS) by demonstrating non-inferiority to the HeartMate II™ LVAS when used for the treatment of advanced refractory left ventricular heart failure.

MOMENTUM 3 is a multicenter, prospective, randomized, pivotal study with an innovative trial design. Patients were enrolled under a single inclusion and exclusion criteria, regardless of the intended use of the device. Outcomes were evaluated in the short term at six months in the first 294 enrolled patients. An additional 72 patients (total of 366 patients- long-term cohort) were enrolled for evaluation of long-term outcomes at two years. Finally, an additional 662 patients (total of 1028 patients—full cohort) were enrolled to evaluate pump reliability at two years. Enrollment began in September 2014 and the two-year study follow-up has been completed.

Below is a comprehensive list of the publications and presentations of analyses from the MOMENTUM 3 short-term cohort, long-term cohort and full cohort.

MOMENTUM 3 STUDY DESIGN

Heatley, G., Sood, P., Goldstein, D., Uriel, N., Cleveland, J., Middlebrook, D., & Mehra, M.R. on behalf of the MOMENTUM 3 Investigators. (2016). Clinical trial design and rationale of the Multicenter Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Support Therapy with HeartMate 3 (MOMENTUM 3) investigational device exemption clinical study protocol. J Heart Lung Transplant, 35 (4), 528-36. https://doi.org/10.1016/j.healun.2016.01.021

This article explains the clinical trial design and rational for the MOMENTUM 3 clinical study protocol.

MOMENTUM 3 FULL COHORT: 1028 PATIENTS FOLLOWED FOR TWO YEARS

FINAL REPORT OF THE TWO-YEAR PRINCIPAL OUTCOMES IN THE MOMENTUM 3 FULL COHORT
FINAL REPORT OF THE TWO-YEAR PRINCIPAL OUTCOMES IN THE MOMENTUM 3 FULL COHORT

Mehra, M.R., Uriel, N., Naka, Y., Cleveland, J.C., Yuzefpolskaya, M., …Goldstein, D.J., for the MOMENTUM 3 Investigators. (2019). A Fully Magnetically Levitated Left Ventricular Assist Device – Final Report. N Engl J Med. https://www.doi.org/10.1056/NEJMoa1900486

The data from two-year followup of the MOMENTUM 3 full cohort demonstrates:

  • Clinical superiority of the HeartMate 3 LVAS when compared to the HeartMate II LVAS
  • Less frequent need for pump replacement with HeartMate 3 LVAS
  • Lower rate of stroke and disabling stroke with HeartMate 3 LVAS
  • Lower rate of gastrointestinal bleeding with HeartMate 3 LVAS
CLINICAL OUTCOMES BY INTENDED GOAL OF THERAPY IN THE MOMENTUM 3 FULL COHORT
 
CLINICAL OUTCOMES BY INTENDED GOAL OF THERAPY IN THE MOMENTUM 3 FULL COHORT

Goldstein, D.J., Uriel, N., Cleveland, J.C., Mehra, M.R., for the MOMENTUM 3 Investigators. (2019). Clinical Outcomes by Intended Goal of Therapy in the MOMENTUM 3 Clinical Trial: Analysis of the Full Cohort. Presented at ISHLT 2019 Annual Meeting, Orlando, FL.

This analysis of the MOMENTUM 3 full cohort demonstrates the following:

  • Pre-implant strategy designations are dynamic and unpredictable
  • Adverse event profiles are similar for patients regardless of pre-implant strategy
  • Pre-implant strategy was not a determining factor in primary endpoint outcomes
HEMOCOMPATIBILITY RELATED OUTCOMES AT TWO YEARS IN THE MOMENTUM 3 FULL COHORT
 
HEMOCOMPATIBILITY RELATED OUTCOMES AT TWO YEARS IN THE MOMENTUM 3 FULL COHORT

Uriel, N., Mehra, M.R., Naka, Y., Boyle, A., …Cleveland, J.C., for the MOMENTUM 3 Investigators. (2019). Long-Term Burden of Hemocompatibility Related Adverse Events in the MOMENTUM 3 Trial: Final Analysis of the 1028 Patient Cohort. Presented at ISHLT 2019 Annual Meeting, Orlando, FL.

This analysis of the MOMENTUM 3 full cohort demonstrates the following:

  • The HeartMate 3 LVAS is clinically superior and more hemocompatible compared to the HeartMate II LVAS
  • HeartMate 3 patients experience an overall halving of the burden of hemocompatibility related adverse events compared to HeartMate II LVAS
HEARTMATE 3 SURGICAL IMPLANT TECHNIQUE AND OUTCOMES IN THE MOMENTUM 3 FULL COHORT
 
HEARTMATE 3 SURGICAL IMPLANT TECHNIQUE AND OUTCOMES IN THE MOMENTUM 3 FULL COHORT

Salerno, C., Naka, Y., Silvestry, S.C., Goldstein, D.J., …Long, J.W., for the MOMENTUM 3 Investigators. (2019). HeartMate 3 Surgical Implant Technique and Outcomes in the MOMENTUM 3 Trial. Presented at ISHLT 2019 Annual Meeting, Orlando, FL.

This analysis of the MOMENTUM 3 full cohort demonstrates the following:

  • Apical cuff attachment, coring location, and driveline management did not significantly impact survival or key adverse events in the full cohort
  • Sew then Core was not associated with a lower stroke risk than Core then Sew
  • Similar excellent results can be obtained with HeartMate 3 LVAS despite significant variability in surgical implant techniques
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HEARTMATE 3 LVAS OUTFLOW GRAFT TWIST OCCLUSION IN THE MOMENTUM 3 FULL COHORT

Mehra, M.R., Salerno, C., Naka, Y., Uriel, N., Cleveland, J.C., Horstmanshof, D., and Goldstein, D.J., for the MOMENTUM 3 Investigators. (2018). A tale of the twist in the outflow graft: An analysis from the MOMENTUM 3 trial. J Heart Lung Transplant, 37 (11), 1281-4. https://doi.org/10.1016/j.healun.2018.08.011

Reports have surfaced of a twist within the outflow graft of the HeartMate 3 LVAS, which have caused disruption in pump flow and required surgical correction. This article analyzes outflow graft twist occlusion in the MOMENTUM 3 trial experience and its clinical presentation.

MOMENTUM 3 LONG-TERM COHORT: 366 PATIENTS FOLLOWED FOR TWO YEARS

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TWO-YEAR PRIMARY OUTCOMES IN THE MOMENTUM 3 LONG-TERM COHORT

Mehra, M.R., Goldstein, D.J., Uriel, N., Cleveland, J.C., Yuzefpolskaya, M., Salerno, C., …, Naka, Y., for the MOMENTUM 3 Investigators. (2018). Two-Year Outcomes with a Magnetically Levitated Cardiac Pump in Heart Failure. N Engl J Med, 378(15), 1386-95. https://www.doi.org/10.1056/NEJMoa1800866

The data from the two-year MOMENTUM 3 trial pre-specified primary analysis demonstrates: 

  • Durability of the HeartMate 3 LVAS to optimally support patients who wait for extended periods for heart transplantation or are ineligible for heart transplantation (destination therapy).
  • Clinical superiority of the HeartMate 3 LVAS when compared to the HeartMate II LVAS axial-flow pump.
  • Lower operation rate in the HeartMate 3 LVAS arm. 
  • Lower rate of stroke with the HeartMate 3 LVAS.
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HEALTHCARE RESOURCE USE AND COST IMPLICATIONS IN THE MOMENTUM 3 LONG-TERM COHORT

Mehra, M.R., Salerno, C., Cleveland, J.C., Pinney, S., Yuzefpolskaya, M., Milano, C. A., ... Silvestry, S.C. (2018)Healthcare Resource Use and Cost Implications in the MOMENTUM 3 Long-Term Outcome Study: Randomized Controlled Trial of a Magnetically Levitated Cardiac Pump in Advanced Heart Failure. Circulation, 138(18), 1923-34. https://doi.org/10.1161/CIRCULATIONAHA.118.035722

In this two-year economic analysis of the MOMENTUM 3 trial, the HeartMate 3 LVAS in comparison with the HeartMate II LVAS demonstrated:

  • Reduction in rehospitalizations.
  • Reduction in hospital days spent during rehospitalizations.
  • Cost savings following discharge.
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COMPREHENSIVE ANALYSIS OF STROKE IN THE MOMENTUM 3 LONG-TERM COHORT

Colombo, P.C., Mehra, M.R., Goldstein, D.J., Estep, J.D., Salerno, C., Jorde, U.P., … Horstmanshof, D.A. (2019). Comprehensive Analysis of Stroke in the Long-Term Cohort of the MOMENTUM 3 Study: A Randomized Controlled Trial of the HeartMate 3 Versus the HeartMate II Cardiac Pump. Circulation, 139 (2), 155-168. https://doi.org/10.1161/CIRCULATIONAHA.118.037231

This comprehensive stroke analysis of the long-term cohort of the MOMENTUM 3 study shows the following:

  • In patients with advanced heart failure, the use of the HeartMate 3 LVAS lowers stroke rates when compared with the HeartMate II LVAS pump.
  • The occurrence of stroke of any type or any functional severity is predictive of a poor two-year clinical outcome.

MOMENTUM 3 SHORT-TERM COHORT: 294 PATIENTS FOLLOWED FOR SIX MONTHS

Presentation slide for “The MOMENTUM 3 Trial: Multicenter Study Of MagLev Technology in Patients Undergoing Mechanical Circulatory Support Therapy with HeartMate 3” from AHA 2016.
 
SIX-MONTH PRIMARY OUTCOMES IN THE MOMENTUM 3 SHORT-TERM COHORT

Mehra, M.R., Naka, Y., Uriel, N., Goldstein, D.J., Cleveland, J.C., Colombo, P.C., …, Salerno, C., for the MOMENTUM 3 Investigators. (2017). A Fully Magnetically Levitated Circulatory Pump for Advanced Heart Failure. N Engl J Med, 376(5), 440-50. https://doi.org/10.1056/NEJMoa1610426

In this primary six-month analysis of the MOMENTUM 3 trial, the HeartMate 3 LVAS demonstrates:

  • Improvement in outcomes driven by a reduction in the need for reoperation or replacement of the HeartMate 3 pump.
  • Patients treated with either the HeartMate 3 LVAS or the HeartMate II LVAS show similar functional quality of life improvement.
  • No suspected or confirmed pump thrombosis events.
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HEMOCOMPATIBILITY RELATED OUTCOMES AT SIX MONTHS IN THE MOMENTUM 3 SHORT-TERM COHORT

Uriel, N., Colombo, P.C., Cleveland, J.C., Long, J.W., Salerno, C., Goldstein, D.J., … Mehra, M.R. (2017). 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, 135(21), 2003-12. https://doi.org/10.1161/CIRCULATIONAHA.117.028303

In this secondary analysis of the MOMENTUM 3 trial, the HeartMate 3 LVAS demonstrated higher freedom from an aggregate of hemocompatibility-related adverse events at six months in comparison to HeartMate II LVAS.

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IMPACT OF AGE, SEX, THERAPEUTIC INTENT, RACE AND SEVERITY OF ADVANCED HEART FAILURE ON SIX-MONTH OUTCOMES IN THE MOMENTUM 3 SHORT-TERM COHORT

Goldstein, D.J., Mehra, M.R., Naka, Y., Salerno, C., Uriel, N., Dean, D., … Cleveland, J. for the MOMENTUM 3 Investigators. (2018). Impact of age, sex, therapeutic intent, race and severity of advanced heart failure on short-term principal outcomes in the MOMENTUM 3 trial, J Heart Lung Transplant, 37 (1), 7-14. https://doi.org/10.1016/j.healun.2017.11.001

This analysis of the MOMENTUM 3 trial demonstrates the following:

  • Younger age at implant and pump choice of HeartMate 3 LVAS versus HeartMate II LVAS were independently associated with a greater likelihood of primary endpoint success.
  • Sex, therapeutic intent, severity of illness and race, when adjusted for age, do not influence primary endpoint success.
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QUALITY OF LIFE AND FUNCTIONAL CAPACITY OUTCOMES AT SIX MONTHS IN THE MOMENTUM 3 SHORT-TERM COHORT

Cowger, J.A., Naka, Y., Aaronson, K.D., Horstmanshof, D., Gulati, S., Rinde-Hoffman, D., … Jorde, U.P. on behalf of the MOMENTUM 3 Investigators. (2018). Quality of life and functional capacity outcomes in the MOMENTUM 3 trial at 6 months: A call for new metrics for left ventricular assist device patients. J Heart Lung Transplant, 37 (1), 15-24. https://doi.org/10.1016/j.healun.2017.10.019

The analysis of this study on health-related quality of life (HR-QOL) and functional capacity shows that:

  • HR-QOL and functional capacity improved significantly in MOMENTUM 3 patients, independent of device use.
  • Two-thirds of patients met the endpoint of “Living Well on an LVAD” at six months.
  • Occurrence of an early serious adverse event did not influence HR-QOL but functional capacity was adversely affected.

SJM-CV WEB-0319-0181(2)

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