Comparative analysis of regional outcomes and adverse events after continuous-flow left ventricular assist device implantation: An IMACS analysis

Mirza, Kiran K; Xie, Rongbing; Cowger, Jennifer; Kirklin, James K.; Meyns, Bart; Gustafsson, Finn; Shaw, Steven M.; Goldstein, Daniel J.

doi:10.1016/j.healun.2020.05.001

Cited by 4 publications

(3 citation statements)

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“…This third EUROMACS report shows a growth of participating hospitals from 52 to 72 since the second report, and the data from the registry were used in an increasing number of scientific studies [9]. In its 10 years of existence, the registry has become a point of reference enabling professionals to put MCS data as a source of scientific data into an international perspective [10][11][12].…”

Section: Discussionmentioning

confidence: 99%

The European Registry for Patients with Mechanical Circulatory Support of the European Association for Cardio-Thoracic Surgery: third report

By¹,

Schoenrath

Veen

et al. 2022

European Journal of Cardio-Thoracic Surgery

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OBJECTIVES In the third report of the European Registry for Patients with Mechanical Circulatory Support of the European Association for Cardio-Thoracic Surgery, outcomes of patients receiving mechanical circulatory support are reviewed in relation to implant era. METHODS Procedures in adult patients (January 2011–June 2020) were included. Patients from centres with <60% follow-ups completed were excluded. Outcomes were stratified into 3 eras (2011–2013, 2014–2017 and 2018–2020). Adverse event rates (AERs) were calculated and stratified into early phase (<3 months) and late phase (>3 months). Risk factors for death were explored using univariable Cox regression with a stepwise time-varying hazard ratio (<3 vs >3 months). RESULTS In total, 4834 procedures in 4486 individual patients (72 hospitals) were included, with a median follow-up of 1.1 (interquartile range: 0.3–2.6) years. The annual number of implants (range: 346–600) did not significantly change (P = 0.41). Both Interagency Registry for Mechanically Assisted Circulatory Support class (classes 4–7: 23, 25 and 33%; P < 0.001) and in-hospital deaths (18.5, 17.2 and 11.2; P < 0.001) decreased significantly between eras. Overall, mortality, transplants and the probability of weaning were 55, 25 and 2% at 5 years after the implant, respectively. Major infections were mainly noted early after the implant occurred (AER<3 months: 1.44 vs AER>3 months: 0.45). Bilirubin and creatinine levels were significant risk factors in the early phase but not in the late phase after the implant. CONCLUSIONS In its 10 years of existence, EUROMACS has become a point of reference enabling benchmarking and outcome monitoring. Patient characteristics and outcomes changed between implant eras. In addition, both occurrence of outcomes and risk factor weights are time dependent.

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Section: Discussionmentioning

confidence: 99%

The European Registry for Patients with Mechanical Circulatory Support of the European Association for Cardio-Thoracic Surgery: third report

By¹,

Schoenrath

Veen

et al. 2022

European Journal of Cardio-Thoracic Surgery

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“…International enrolment is important as regional variations in LVAD management practice and, possibly, differences in risk of adverse events have been demonstrated. 37 Therefore, the ARIES HM3 trial must conform to multiple regulatory frameworks. ISO standards require that patients be enrolled at the time of consent, however, scientifically, our primary focus in this study is on randomized patients.…”

Section: Discussion Of Unique Study Featuresmentioning

confidence: 99%

Aspirin and left ventricular assist devices: rationale and design for the international randomized, placebo‐controlled, non‐inferiority ARIES HM3 trial

Mehra

Crandall

Gustafsson

et al. 2021

European J of Heart Fail

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Over decades, left ventricular assist device (LVAD) technology has transitioned from less durable bulky pumps to smaller continuous-flow pumps which have substantially improved long-term outcomes and quality of life. Contemporary LVAD therapy is beleaguered by haemocompatibility-related adverse events including thrombosis, stroke and bleeding. A fully magnetically levitated pump, the HeartMate 3 (HM3, Abbott, USA) LVAD, has been shown to be superior to the older HeartMate II (HMII, Abbott, USA) pump by improving haemocompatibility. Experience with the HM3 LVAD suggests near elimination of de-novo pump thrombosis, a marked reduction in stroke rates, and only a modest decrease in bleeding complications. Since the advent of continuous-flow LVAD therapy, patients have been prescribed a combination of aspirin and anticoagulation therapy on the presumption that platelet activation and perturbations to the haemostatic axis determine their necessity. Observational studies in patients implanted with the HM3 LVAD who suffer bleeding have suggested a signal of reduced subsequent bleeding events with withdrawal of aspirin. The notion of whether antiplatelet therapy can be avoided in an effort to reduce bleeding complications has now been advanced.

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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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Comparative analysis of regional outcomes and adverse events after continuous-flow left ventricular assist device implantation: An IMACS analysis

Cited by 4 publications

References 28 publications

The European Registry for Patients with Mechanical Circulatory Support of the European Association for Cardio-Thoracic Surgery: third report

The European Registry for Patients with Mechanical Circulatory Support of the European Association for Cardio-Thoracic Surgery: third report

Aspirin and left ventricular assist devices: rationale and design for the international randomized, placebo‐controlled, non‐inferiority ARIES HM3 trial

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

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