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Clinical Outcomes With a Fully Magnetically Levitated Left Ventricular Assist Device Among Women and Men.
Ramu, Bhavadharini; Cogswell, Rebecca; Ravichandran, Ashwin K; Cleveland, Joseph; Mehra, Mandeep R; Goldstein, Daniel; Uriel, Nir; Dirckx, Nicholas; Ahmed, Sara; Yuzefpolskaya, Melana.
Afiliação
  • Ramu B; University of Minnesota, Minneapolis, Minnesota, USA. Electronic address: bramu@umn.edu.
  • Cogswell R; University of Minnesota, Minneapolis, Minnesota, USA.
  • Ravichandran AK; Ascension St Vincent, Indianapolis, Indiana, USA.
  • Cleveland J; University of Colorado School of Medicine, Aurora, Colorado, USA.
  • Mehra MR; Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston, Massachusetts, USA.
  • Goldstein D; Montefiore Einstein Center for Heart and Vascular Care, New York, New York, USA.
  • Uriel N; Columbia University College of Physicians and Surgeons and New York-Presbyterian Hospital, New York, New York, USA.
  • Dirckx N; Abbott Inc, Abbott Park, Illinois, USA.
  • Ahmed S; Abbott Inc, Abbott Park, Illinois, USA.
  • Yuzefpolskaya M; Columbia University College of Physicians and Surgeons and New York-Presbyterian Hospital, New York, New York, USA.
JACC Heart Fail ; 11(12): 1692-1704, 2023 12.
Article em En | MEDLINE | ID: mdl-37831046
ABSTRACT

BACKGROUND:

Left ventricular assist devices (LVADs) are underused among women with advanced heart failure, but reasons remain unclear. Outcomes in women compared with men with contemporary fully magnetically levitated LVADs remain uncertain.

OBJECTIVES:

The authors examined differences in characteristics, 2-year outcomes, and risk for key adverse events among women and men.

METHODS:

In 2,200 HeartMate3 (HM3) (Abbott Cardiovascular) LVAD recipients in the MOMENTUM 3 study (Multicenter Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Support Therapy with HeartMate 3), survival free of disabling stroke or reoperation to replace or remove a malfunctioning pump at 2 years was analyzed between women and men. Other outcomes included overall 2-year survival, adverse events, and functional measures.

RESULTS:

Women comprised 20.4% (n = 448 of 2,200) of the study population and were younger, with nonischemic cardiomyopathy, and more often were Black persons compared with men. The primary endpoint (women 79.4% vs men 75.5% (adjusted [a]HR 0.96 [95% CI 0.75-1.24]; P = 0.66) or survival at 2 years (women 82.4% vs men 80.2%; aHR 1.06 [95% CI 0.81-1.40]; P = 0.66) was no different. Women had an increased rate of stroke (adjusted incidence rate ratio [aIRR] 1.52 [95% CI 1.09-2.11]; P = 0.012), major bleeding (aIRR 1.28 [95% CI 1.15-1.42]; P < 0.0001) and infection (aIRR 1.14 [95% CI 1.03-1.55]; P = 0.01), but these differences were not seen among older (>65 years) patients. Both groups had similar gains in 6-minute walk distance and quality-of-life measurements.

CONCLUSIONS:

There were no differences in the primary composite endpoint or overall survival in women compared with men at 2 years of support. Reasons underlying increase in hemocompatibility-related events and infection-related morbidity in younger women deserves further study. (MOMENTUM 3 IDE [HM3], NCT02224755; MOMENTUM 3 Continued Access Protocol [MOMENTUM 3 CAP], NCT02892955).
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Coração Auxiliar / Acidente Vascular Cerebral / Insuficiência Cardíaca Limite: Female / Humans / Male Idioma: En Ano de publicação: 2023 Tipo de documento: Article

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Coração Auxiliar / Acidente Vascular Cerebral / Insuficiência Cardíaca Limite: Female / Humans / Male Idioma: En Ano de publicação: 2023 Tipo de documento: Article