Association of Clinical Outcomes With Left Ventricular Assist Device Use by Bridge to Transplant or Destination Therapy Intent: The Multicenter Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Support Therapy With HeartMate 3 (MOMENTUM 3) Randomized Clinical Trial
Left ventricular assist devices (LVADs) are well established in the treatment of advanced heart failure, but it is unclear whether outcomes are different based on the intended goal of therapy in patients who are eligible vs ineligible for heart transplant.
OBJECTIVE:To determine whether clinical outcomes in the Multicenter Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Support Therapy With HeartMate 3 (MOMENTUM 3) trial differed by preoperative categories of bridge to transplant (BTT) or bridge to transplant candidacy (BTC) vs destination therapy (DT).
DESIGN, SETTING, AND PARTICIPANTS:This study was a prespecified secondary analysis of the MOMENTUM 3 trial, a multicenter randomized clinical trial comparing the magnetically levitated centrifugal-flow HeartMate 3 (HM3) LVAD to the axial-flow HeartMate II (HMII) pump. It was conducted in 69 centers with expertise in managing patients with advanced heart failure in the United States. Patients with advanced heart failure were randomized to an LVAD, irrespective of the intended goal of therapy (BTT/BTC or DT).
MAIN OUTCOMES AND MEASURES:The primary end point was survival free of disabling stroke or reoperation to remove or replace a malfunctioning device at 2 years. Secondary end points included adverse events, functional status, and quality of life.
RESULTS:Of the 1020 patients with implants (515 with HM3 devices [50.5%] and 505 with HMII devices [49.5%]), 396 (38.8%) were in the BTT/BTC group (mean [SD] age, 55 [12] years; 310 men [78.3%]) and 624 (61.2%) in the DT group (mean [SD] age, 63 [12] years; 513 men [82.2%]). Of the patients initially deemed as transplant ineligible, 84 of 624 patients (13.5%) underwent heart transplant within 2 years of LVAD implant. In the primary end point analysis, HM3 use was superior to HMII use in patients in the BTT/BTC group (76.8% vs 67.3% for survival free of disabling stroke and reoperation; hazard ratio, 0.62 [95% CI, 0.40-0.94]; log-rank P = .02) and patients in the DT group (73.2% vs 58.7%; hazard ratio, 0.61 [95% CI, 0.46-0.81]; log-rank P < .001). For patients in both BTT/BTC and DT groups, there were not significantly different reductions in rates of pump thrombosis, stroke, and gastrointestinal bleeding with HM3 use relative to HMII use. Improvements in quality of life and functional capacity for either pump were not significantly different regardless of preimplant strategy.
CONCLUSIONS AND RELEVANCE:In this trial, the superior treatment effect of HM3 over HMII was similar for patients in the BTT/BTC or DT groups. It is possible that use of arbitrary categorizations based on current or future transplant eligibility should be clinically abandoned in favor of a single preimplant strategy: to extend the survival and improve the quality of life of patients with medically refractory heart failure.
TRIAL REGISTRATION:ClinicalTrials.gov identifier: NCT02224755.
CET Conclusion
| Reviewer: | Mr John O'Callaghan, Centre for Evidence in Transplantation, Nuffield Department of Surgical Sciences, University of Oxford |
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| Conclusion: | This is another report from the MOMENTUM-3 study comparing a fully magnetically levitated circulatory pump with a commercially available axial-flow pump for advanced heart failure. Previous publications had shown that the centrifugal-flow pump was associated with better outcomes at 6 months than the axial-flow pump. The trial was well-conducted, multicentre, un-blinded and randomised controlled trial with full follow up. The analysis presented here was pre-specified in the protocol. The key aim of this analysis was to see if outcomes with the two LVADs differed by the intended treatment intention of the therapy, as a bridge to transplantation or destination therapy. The primary end-point was a composite outcome of survival free from disabling stroke or reoperation to remove or replace a malfunctioning device. This outcome was significantly better for patients with the centrifugal-flow pump rather than the axial-flow pump regardless of treatment intention (HR=0.62 if bridge to transplant and HR=0.61 if destination therapy). A test of interaction showed no significant difference between the impact of the LVAD type on the two populations. The centrifugal-flow pump was associated with significantly fewer episodes of pump thrombosis, stroke and bleeding, also irrespective of treatment intention. |
Methodological quality
| Jadad score | 3 |
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| Allocation concealment | YES |
| Data analysis | INTENTION TO TREAT |
Study Details
| Aims: | This was a secondary analysis of the MOMENTUM 3 trial which aimed to evaluate the impact of therapeutic intent on the short-term and long term outcomes of HeartMate 3 (HM3) as compared to HeartMate II (HMII) in patients with advanced heart failure. |
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| Interventions: | Patients were randomized in a 1:1 ratio to receive either the the magnetically levitated centrifugal-flow HeartMate 3 (HM3) left ventricular assist device (LVAD) or the the axial-flow HeartMate II (HMII) pump, regardless of the intended goal of therapy (bridge to transplant (BTT)/ bridge to transplant candidacy (BTC) or destination therapy (DT)). |
| Participants: | The study enrolled 1028 patients with advanced-stage heart failure that were considered to be candidates for LVAD therapy. |
| Outcomes: | The primary outcome was disabling stroke-free survival or reoperation to either remove or replace an impaired device at 2 years. The secondary outcome were adverse events, rehospitalizations, functional capacity and quality of life. |
| Follow Up: | 2 years |
Metadata
| Funding: | Industry funding |
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| Publication type: | Multicenter Study, Randomized Controlled Trial, Randomised Controlled Trial |
| Trial registration: | ClinicalTrials.gov - NCT02224755 |
| Organ: | Heart |
| Language: | Engish |
| Author email: | mmehra@bwh.harvard.edu |
| MeSH terms: | Adolescent; Adult; Aged; Aged, 80 and over; Equipment Failure; Female; Heart Failure; Heart Transplantation; Heart-Assist Devices; Humans; Male; Middle Aged; Patient Care Planning; Quality of Life; Reoperation; Survival Analysis; Treatment Outcome; Young Adult; Aged, 80 and Over |