Five-Year Outcomes in Patients With Fully Magnetically Levitated vs Axial-Flow Left Ventricular Assist Devices in the MOMENTUM 3 Randomized Trial

Abstract

ImportanceAlthough durable left ventricular assist device (LVAD) therapy has emerged as an important treatment option for patients with advanced heart failure refractory to pharmacological support, outcomes, including survival, beyond 2 years remain poorly characterized.ObjectiveTo report the composite end point of survival to transplant, recovery, or LVAD support free of debilitating stroke (Modified Rankin Scale score >3) or reoperation to replace the pump 5 years after the implant in participants who received the fully magnetically levitated centrifugal-flow HeartMate 3 or axial-flow HeartMate II LVAD in the MOMENTUM 3 randomized trial and were still receiving LVAD therapy at the 2-year follow-up.Design, Setting, and ParticipantsThis observational study was a 5-year follow-up of the MOMENTUM 3 trial, conducted in 69 US centers, that demonstrated superiority of the centrifugal-flow LVAD to the axial-flow pump with respect to survival to transplant, recovery, or LVAD support free of debilitating stroke or reoperation to replace the pump at 2 years. A total of 295 patients were enrolled between June 2019 to April 2021 in the extended-phase study, with 5-year follow-up completed in September 2021.ExposuresOf 1020 patients in the investigational device exemption per-protocol population, 536 were still receiving LVAD support at 2 years, of whom 289 received the centrifugal-flow pump and 247 received the axial-flow pump.Main Outcomes and MeasuresThere were 10 end points evaluated at 5 years in the per-protocol population, including a composite of survival to transplant, recovery, or LVAD support free of debilitating stroke or reoperation to replace the pump between the centrifugal-flow and axial-flow pump groups and overall survival between the 2 groups.ResultsA total of 477 patients (295 enrolled and 182 provided limited data) of 536 patients still receiving LVAD support at 2 years contributed to the extended-phase analysis (median age, 62 y; 86 [18%] women). The 5-year Kaplan-Meier estimate of survival to transplant, recovery, or LVAD support free of debilitating stroke or reoperation to replace the pump in the centrifugal-flow vs axial-flow group was 54.0% vs 29.7% (hazard ratio, 0.55 [95% CI, 0.45-0.67]; P < .001). Overall Kaplan-Meier survival was 58.4% in the centrifugal-flow group vs 43.7% in the axial-flow group (hazard ratio, 0.72 [95% CI, 0.58-0.89]; P = .003). Serious adverse events of stroke, bleeding, and pump thrombosis were less frequent in the centrifugal-flow pump group.Conclusions and RelevanceIn this observational follow-up study of patients from the MOMENTUM 3 randomized trial, per-protocol analyses found that receipt of a fully magnetically levitated centrifugal-flow LVAD vs axial-flow LVAD was associated with a better composite outcome and higher likelihood of overall survival at 5 years. These findings support the use of the fully magnetically levitated LVAD.Trial RegistrationClinicalTrials.gov Identifier: NCT02224755 and NCT03982979

Ventricular Assist Device Driveline Infections: A Systematic Review

“…Unlike Schloglhofer et al study, 14 MOMENTUM 3 trial described nonsignificant differences in DLI incidence between HMII (19,4%) and HM3 (23,3%) patients, respectively. 57…”

Reciprocal interferences of the left ventricular assist device and the aortic valve competence

“…An overall survival rate of 74.5% was seen when fully magnetized centrifugal-flow LVADs were used in real-world population using 2-year results from the ELEVATE registry ( 32 ). The MOMENTUM 3 trial demonstrated that, in centrifugal-flow LVADs, the 2-year survival rate was 84.5%, while the stroke-free and need for reoperation rate, due to LVAD malfunction, was 76.9% ( 24 ), confirmed by the more recent MOMENTUM 3, 5 years outcome ( 33 ). Additionally, even though numerous patients have been planned to be implanted as DT or BTT (mid and long term destination), some of these can turn in bridge to recovery when weaning criteria are satisfy, included no AR or maximum grade I AR.…”

Key questions about aortic insufficiency in patients with durable left ventricular assist devices

“…Most patients are now implanted as destination therapy or bridge to candidacy ( 2 ). Survival following LVAD implantation has reached 90% ( 3 ) and 58.4% at 1 and 5 years ( 4 ). Although a significant reduction in adverse events such as pump thrombosis or stroke is observed, time-related adverse events such as aortic insufficiency (AI) remain an area of concern in the context of increased support duration ( 5 ).…”