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HeartMate 3 LVAD Outcomes in Women and Men
Quick Takes
- Women compared to men receiving HeartMate 3 LVAD therapy had similar survival free of disabling stroke or reoperation to replace or remove a malfunctioning pump at 2-years post-implant.
- Women experienced higher rates of all-cause stroke, disabling strokes, bleeding, and major infection post-implant.
- Women and men both experienced improved functional capacity and quality of life post-implant, with no significant difference between the groups.
Study Questions:
Among patients with advanced heart failure receiving HeartMate 3 (HM3) left ventricular assist device (LVAD) therapy, what are the differences in clinical outcomes between women and men?
Methods:
This was a post hoc analysis of the MOMENTUM 3 pivotal trial [HM3 vs HeartMate II (HMII) LVAD therapy] and the continued access protocol (single-arm HM3 LVAD therapy). A total of 2,200 patients receiving HM3 LVAD therapy were included in this analysis, 515 from the pivotal trial and 1,685 from the continued access protocol.
The primary outcome of interest was survival free of disabling stroke or reoperation to replace or remove a malfunctioning pump at 2-years post-implant. Secondary outcomes of interest were 2-year survival, adverse event (AE) rate, 6-minute walk distance (6MWD), and quality of life (QOL). Outcomes for men and women were compared.
Results:
Of the 2,200 patients with HM3 LVADs, 448 were women (20.4%) and 1,752 were men (79.6%). Women compared to men in this analysis were younger, more likely to be Black, and more likely to have an idiopathic/dilated cardiomyopathy. Several unadjusted differences in baseline comorbidities, echocardiographic data, hemodynamic data, and laboratory values were noted.
There was no significant difference in the primary composite endpoint after adjustment when comparing women to men (79.4% vs. 75.5%, adjusted hazard ratio [aHR], 0.96; 95% confidence interval [CI], 0.75-1.24; p = 0.76). For the secondary endpoints, there was no significant difference in 2-year survival between women and men (82.4% vs. 80.2%, aHR, 1.06; 95% CI, 0.81-1.40; p = 0.66). With respect to incidence of important LVAD-associated AEs at 2 years of follow-up, women compared to men had higher rates of all-cause stroke (adjusted incidence rate ratio [aIRR], 1.52; 95% CI, 1.09-2.11; p = 0.012), disabling strokes (aIRR, 1.71; 95% CI, 1.06-2.76; p = 0.028), any bleeding (driven by nonsurgical and gastrointestinal bleeding) (aIRR, 1.28; 95% CI, 1.15-1.42; p < 0.0001), and any major infection (aIRR, 1.14; 95% CI, 1.03-1.26; p = 0.01). Women compared to men had lower rates of any arrhythmia (aIRR, 0.85; 95% CI, 0.61-0.97; p = 0.03). There were no differences seen in rates of suspected pump thrombosis or any right heart failure. Both women and men experienced improvements in 6MWD and patient-reported QOL measures, with no difference noted between groups.
Conclusions:
Among patients with advanced heart failure receiving HM3 LVAD therapy, there was no significant difference between women and men for the primary outcome of survival free of disabling stroke or reoperation to replace or remove a malfunctioning pump at 2-years post-implant. Differences were noted in the rates of AEs. No differences were noted for functional and patient-reported outcomes, with both women and men showing similar improvements.
Perspective:
Despite the high prevalence and incidence of heart failure, advanced therapies like LVADs are underutilized in women. In addition, prior research suggests that differences in clinical outcomes post-implant exist between women and men. This study seeks to improve understanding of this important problem by assessing for difference in clinical outcomes between women and men among patients receiving contemporary LVAD therapy with the HM3 device. It is reassuring that this analysis did not find any significant differences in survival free of disabling stroke or reoperation to replace or remove a malfunctioning pump, overall survival, and functional and QOL measures. However, higher rates of stroke, bleeding, and infection among women are notable. Further investigation will be needed to understand why these differences exist to allow for more optimal care.
Clinical Topics: Cardiac Surgery, Heart Failure and Cardiomyopathies, Cardiac Surgery and Heart Failure, Mechanical Circulatory Support
Keywords: Acute Heart Failure, Heart-Assist Devices, Sex Characteristics
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