Global challenges in left ventricular assist device therapy: a tale across two continents

Nayak, Aditi; Mehra, Mandeep R.

doi:10.1002/ejhf.2570

Cited by 4 publications

(2 citation statements)

References 16 publications

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“…Second, most patients (85%) in the study were recruited from North America, and there is wide variation in patient enrollment across the remaining geographic territories. Therefore, observed geographical interactions are limited by the differential in sample size . Further detailed analyses in this regard are planned because other factors related to health care system differences, which may require scrutiny, cannot be excluded.…”

Section: Discussionmentioning

confidence: 99%

Aspirin and Hemocompatibility Events With a Left Ventricular Assist Device in Advanced Heart Failure

Mehra,

Netuka,

Uriel

et al. 2023

JAMA

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IMPORTANCELeft ventricular assist devices (LVADs) enhance quality and duration of life in advanced heart failure. The burden of nonsurgical bleeding events is a leading morbidity. Aspirin as an antiplatelet agent is mandated along with vitamin K antagonists (VKAs) with continuous-flow LVADs without conclusive evidence of efficacy and safety.OBJECTIVETo determine whether excluding aspirin as part of the antithrombotic regimen with a fully magnetically levitated LVAD is safe and decreases bleeding.DESIGN, SETTING, and PARTICIPANTSThis international, randomized, double-blind, placebo-controlled study of aspirin (100 mg/d) vs placebo with VKA therapy in patients with advanced heart failure with an LVAD was conducted across 51 centers with expertise in treating patients with advanced heart failure across 9 countries. The randomized population included 628 patients with advanced heart failure implanted with a fully magnetically levitated LVAD (314 in the placebo group and 314 in the aspirin group), of whom 296 patients in the placebo group and 293 in the aspirin group were in the primary analysis population, which informed the primary end point analysis. The study enrolled patients from July 2020 to September 2022; median follow-up was 14 months.InterventionPatients were randomized in a 1:1 ratio to receive aspirin (100 mg/d) or placebo in addition to an antithrombotic regimen.MAIN OUTCOMES AND MEASURESThe composite primary end point, assessed for noninferiority (−10% margin) of placebo, was survival free of a major nonsurgical (&gt;14 days after implant) hemocompatibility-related adverse events (including stroke, pump thrombosis, major bleeding, or arterial peripheral thromboembolism) at 12 months. The principal secondary end point was nonsurgical bleeding events.RESULTSOf the 589 analyzed patients, 77% were men; one-third were Black and 61% were White. More patients were alive and free of hemocompatibility events at 12 months in the placebo group (74%) vs those taking aspirin (68%). Noninferiority of placebo was demonstrated (absolute between-group difference, 6.0% improvement in event-free survival with placebo [lower 1-sided 97.5% CI, −1.6%]; P &lt; .001). Aspirin avoidance was associated with reduced nonsurgical bleeding events (relative risk, 0.66 [95% confidence limit, 0.51-0.85]; P = .002) with no increase in stroke or other thromboembolic events, a finding consistent among diverse subgroups of patient characteristics.CONCLUSIONS AND RELEVANCEIn patients with advanced heart failure treated with a fully magnetically levitated LVAD, avoidance of aspirin as part of an antithrombotic regimen, which includes VKA, is not inferior to a regimen containing aspirin, does not increase thromboembolism risk, and is associated with a reduction in bleeding events.TRIAL REGISTRATIONClinicalTrials.gov Identifier: NCT04069156

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Section: Discussionmentioning

confidence: 99%

Aspirin and Hemocompatibility Events With a Left Ventricular Assist Device in Advanced Heart Failure

Mehra,

Netuka,

Uriel

et al. 2023

JAMA

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“…52 The reduced hospitalizations and decreased adverse effects with the HM 3 LVAD have moved the technology closer toward acceptance thresholds for cost-effectiveness worldwide, but scalability and equity challenges remain. 53…”

Section: Other Devicesmentioning

confidence: 99%

Contemporary Left Ventricular Assist Device Therapy as a Bridge or Alternative to Transplantation

Boulet,

Wanderley,

Mehra

2023

Transplantation

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Left ventricular assist devices (LVADs), which were introduced as a bridge to heart transplantation, are now an established alternative to heart transplantation (HT) for patients with advanced heart failure. These devices have undergone significant technological advancements over the years, and contemporary LVADs prolong life substantially in patients dependent on inotropic therapy or in those with severe ambulatory advanced heart failure with a median survival that exceeds 5 y, and most patients benefit from a doubling in functional capacity, even among those intended as destination therapy because of ineligibility for transplantation. Other intended goals for LVAD implantation consist of (1) bridge to remission or recovery and (2) bridge to transplant or candidacy for transplant. In the former situation, few selected patients underwent LVAD implantation, facilitating myocardial remission to recovery that allowed explantation. Among those bridged to transplantation, survival in the intended goal was excellent, with 80% success at 5 y (with a 50% rate of transplantation). In this review, we provide a brief historical background on the evolution of LVADs and discuss outcomes with contemporary pumps, immunological and infection-related impact of such devices, impact of bridging in HT, and use of devices for facilitating myocardial recovery and remission. Furthermore, we discuss implications of HT allocation policies, with a specific focus within the United States, and outline future perspectives and novel device in development.

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Hemodynamic Aberrancies in Left Ventricular Assist Device–Associated Heart Failure Syndromes

Boulet

Nayak

Mehra

2022

Journal of Cardiac Failure

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Global challenges in left ventricular assist device therapy: a tale across two continents

Cited by 4 publications

References 16 publications

Aspirin and Hemocompatibility Events With a Left Ventricular Assist Device in Advanced Heart Failure

Aspirin and Hemocompatibility Events With a Left Ventricular Assist Device in Advanced Heart Failure

Contemporary Left Ventricular Assist Device Therapy as a Bridge or Alternative to Transplantation

Hemodynamic Aberrancies in Left Ventricular Assist Device–Associated Heart Failure Syndromes

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