Sex-Specific Outcome Disparities in Patients Receiving Continuous-Flow Left Ventricular Assist Devices: A Systematic Review and Meta-analysis

Abstract

Continuous-flow left ventricular assist devices (CF-LVADs) decrease mortality and improve quality of life in patients with advanced heart failure (HF). Their widespread utilization has led to concerns regarding increased adverse effects, especially in women. Nevertheless, sex-specific data remain limited. We searched Medline, Embase, Scopus, and the Cochrane Library for publications reporting sex-specific outcomes after CF-LVADs from January 2008 through January 2017. Outcomes were compared under the random-effects model and heterogeneity examined via χ test and I statistics. A total of 10 studies including 4,493 CF-LVAD recipients were included in the analysis (23.5% women). The overall rate of stroke was significantly higher in women (odds ratio [OR] 1.94; 95% confidence interval [CI] 1.32-2.84; p = 0.0007). This was true for ischemic strokes (OR 2.03; 95% CI 1.21-3.42; p = 0.008) and hemorrhagic strokes (OR 2.03; 95% CI 1.21-3.42; p = 0.008). Women were also more likely to develop right HF necessitating right ventricular assist device (RVAD) implantation (OR 2.12; 95% CI 1.08-4.15; p = 0.03). Other adverse events including renal failure, bleeding, and device-related infection were comparable for both genders. The overall mortality while on CF-LVAD was similar in both groups (OR 1.05; 95% CI 0.81-1.36; p = 0.71). Our analysis suggests that women are at greater risk of significant complications such as cerebrovascular events and right HF necessitating RVAD after CF-LVAD implantation. Further research is needed to better understand the mechanisms underlying these sex-specific outcome disparities.

Mechanical Circulatory Support in Women

“…In a meta-analysis of 10 studies, the rates of ischemic and hemorrhagic strokes and RVF necessitating RVAD implantation were significantly higher in women, while renal failure, bleeding, device-related infection, and overall mortality were comparable for both genders [62].…”

Gender differences in psychosocial and clinical characteristics in the European Registry for Patients with Mechanical Circulatory Support

“…31 Only women intended for BTT were less likely than men to have a history of alcohol abuse, whereas according to US data that combined all devices and strategies women are generally less likely than men to have a history of alcohol abuse. 3,7 Whether women's lower substance abuse and smoking are associated with improved clinical outcomes needs to be further determined. 32 Current EUROMACS data do not allow to draw strong conclusions regarding other types of health behaviors such as physical activity or diet, except that women and men did not differ in BMI, which is largely influenced by these health behaviors.…”

“…3,6 A higher risk for worse clinical outcomes after MCS implantation in women compared to men might contribute to this disparity. There is some indication that women have a higher risk for adverse events after device implantation when compared to men, 6,7 particularly regarding neurologic events. 8 Reports on survival differences in women and men, however, are conflicting, some indicating similar survival for women and men, 4,[6][7][8][9] others reduced survival for women.…”

“…There is some indication that women have a higher risk for adverse events after device implantation when compared to men, 6,7 particularly regarding neurologic events. 8 Reports on survival differences in women and men, however, are conflicting, some indicating similar survival for women and men, 4,[6][7][8][9] others reduced survival for women. 3,10,11 To gain a better understanding of gender differences in clinical outcomes after MCS implantation, a systematic examination of male and female populations before receiving MCS is warranted.…”

Sex-Related Differences in Outcomes of Thoracic Organ Transplantation and Mechanical Circulatory Support

“…Women had a 50% increase in stroke risk after implantation, and female sex was an independent predictor; the authors proposed that endogenous estrogen affects coagulation status and predisposes women to strokes. Blumer and colleagues 12 performed a meta-analysis to evaluate sexspecific outcome disparities in continuous-f low LVAD recipients and reported a 90% increase in stroke risk for women. In addition, women were twice as likely to need a right VAD.…”