Sex Differences in Patients Receiving Left Ventricular Assist Devices for End-Stage Heart Failure

Gruen, Jadry; Caraballo, César; Miller, Paul E.; McCullough, Megan; Mezzacappa, Catherine; Ravindra, Neal G.; Mullan, Clancy; Reinhardt, Samuel W.; Mori, Makoto; Velázquez, Eric J.; Geirsson, Arnar; Ahmad, Tariq; Desai, Nihar R.

doi:10.1016/j.jchf.2020.04.015

Cited by 42 publications

(67 citation statements)

References 31 publications

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“… 10 , 11 Some of the previous reports (mostly based on patients intended for BTT or combined strategies) suggest that female recipients of LVADs may have worse clinical outcomes compared with their male counterparts. 2 , 3 , 5 , 9 However, women intended for BTT are generally more medically disadvantaged (more severely ill, less ideal transplant candidates) when receiving a device than men. 30 , 31 Therefore, compared with men, they are less likely to be transplanted, resulting in longer waitlist time and time on device support, thereby increasing their risk for death with LVAD.…”

Section: Discussionmentioning

confidence: 99%

“…Sex differences in clinical outcomes of DT patients have been examined previously but are difficult to interpret, because many studies do not differentiate between device types (LVAD, bi‐VAD, total artificial heart, pulsatile versus continuous) and device strategies. For example, a higher risk of death after LVAD implantation in women compared with men has been reported in 4 studies using INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support), 2 , 3 IMACS (International Society for Heart and Lung Transplantation Registry for Mechanically Assisted Circulatory Support), 4 and EUROMACS (European Registry for Patients with Mechanical Circulatory Support) data, 5 whereas others could not confirm any sex differences in mortality. 6 , 7 All these studies combined devices and/or strategies.…”

mentioning

confidence: 98%

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Sex Differences in Recovery and Device Replacement After Left Ventricular Assist Device Implantation as Destination Therapy

Maukel

Weidner

Beyersmann³

et al. 2022

JAHA

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Background The relevance of sex and preimplant factors for clinical outcomes among patients with left ventricular assist devices intended for destination therapy is unclear. Methods and Results INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support) data (2006‐2017) from 6771 men and 1690 women with left ventricular assist devices as destination therapy were analyzed to evaluate the contribution of preimplant clinical, demographic, and clinically judged psychosocial characteristics to time until death, heart transplant, device explant due to recovery, or complication‐related device replacement. Associations of sex with time until each competing outcome were evaluated using cumulative incidence functions and event‐specific Cox proportional hazards models. Women were younger, more likely to have nonischemic diagnoses, and reported less substance abuse but were more likely to be unmarried, not working for an income, overweight, and depressed than men. After 2 years, women had higher probabilities for recovery (3.7% versus 1.6%, P <0.001) and device replacement (12.1% versus 10%, P =0.019) than men but not for death and transplant ( P >0.12). The sex differences remained after controlling for covariates (adjusted hazard ratio [HR adj ] recovery, 1.85; 95% CI, 1.30–2.70; P <0.001; HR adj device replacement, 1.22; 95% CI, 1.04–1.33; P =0.015). Female‐specific diagnoses (eg, postpartum heart failure) contributed to women’s enhanced rate of recovery. Demographic and psychosocial factors were unrelated to women’s increased event rates. Conclusions In destination therapy, women have higher rates of device replacement and recovery than men. The latter was partly explained by female‐specific diagnoses. Standardized assessments of psychosocial characteristics are needed to elucidate their association with sex differences in outcomes.

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Section: Discussionmentioning

confidence: 99%

mentioning

confidence: 98%

Sex Differences in Recovery and Device Replacement After Left Ventricular Assist Device Implantation as Destination Therapy

Maukel

Weidner

Beyersmann³

et al. 2022

JAHA

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show abstract

Section: Discussionmentioning

confidence: 97%

“…Alternatively, the interaction of sex and LVADs as noted in other studies may be related to either patient selection or the specific device implanted. 38 In the pivotal trial phase of MOMENTUM 3, we were unable to report any interaction between sex and the primary trial outcome. 3 One of the principal strengths of the present analysis is that it possesses sufficient power (owing to its large cohort of Black patients) to reveal an adverse impact of race on device-related outcomes.…”

Section: Discussionmentioning

confidence: 97%

Impact of Race on Clinical Outcomes After Implantation With a Fully Magnetically Levitated Left Ventricular Assist Device: An Analysis From the MOMENTUM 3 Trial

Sheikh

Ravichandran

Goldstein

et al. 2021

Circ: Heart Failure

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Background: Heart failure disproportionately affects Black patients. Whether differences among race influence outcomes in advanced heart failure with use of a fully magnetically levitated continuous-flow left ventricular assist device remains uncertain. Methods: We included 515 IDE (Investigational Device Exemption) clinical trial patients and 500 Continued Access Protocol patients implanted with the HeartMate 3 left ventricular assist device in the MOMENTUM 3 study (Multicenter Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Support Therapy With HeartMate 3). Outcomes were compared between Black and White left ventricular assist device recipients for the primary end point of survival free of disabling stroke or reoperation to replace or remove a malfunctioning device at 2 years, overall survival, adverse events, 6-minute walk distance, and quality of life scores. Results: Of 1015 HeartMate 3 patients, 675 were self-identified as White and 285 as Black individuals. The Black patient cohort was younger, more obese and with a history of hypertension, and more nonischemic cause of heart failure, relative to the White patient group. Black and White patients did not experience a difference in the primary end point (81.1% versus 77.9%; hazard ratio, 1.08 [95% CI, 0.76–1.54], P =0.6568). Black patients were at higher risk of adverse events (calculated as events per 100 patient-years), including bleeding (75.4 versus 63.5; P <0.0001), stroke (9.5 versus 7.2; P =0.0183), and hypertension (10.1 versus 3.2; P <0.0001). The 6-minute walk distance was not different at baseline and 6 months between the groups, however, the absolute change from baseline was greater for White patients (median: +183.0 [interquartile range, 42.0–335.3] versus +163.8 [interquartile range, 42.3–315.0] meters, P =0.01). The absolute quality of life measurement (EuroQoL group, 5-dimension, 5-level instrument visual analog scale) at baseline and 6 months was better in the Black patient group, but relative improvement from baseline to 6 months was greater in White patients (median: +20.0 [interquartile range, 5.0–40.0] versus +25.0 [interquartile range, 10.0–45.0]; P =0.0298). Conclusions: Although the survival free of disabling stroke or reoperation to replace/remove a malfunctioning device at 2 years with the HM 3 left ventricular assist device did not differ by race, Black HeartMate 3 patients experienced a higher morbidity burden and smaller gains in functional capacity and quality of life when compared with White patients. These findings require efforts designed to better understand and overcome these gaps through systematic identification and tackling of putative factors. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifiers: NCT02224755 and NCT02892955.

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“…This study demonstrated that female gender is associated with higher mortality after LVAD implantation, but this effect is observed only in the first 4 months after the assist device implantation. 18 , 19 The authors claim that this phenomenon is driven by worsening of the right ventricular dysfunction and the LVAD-patient size mismatch. In our study, we did not see a significant worsening of the right ventricular dysfunction in the female group compared to the matched male group.…”

Section: Discussionmentioning

confidence: 99%

Impact of gender in patients with continuous-flow left ventricular assist device therapy in end-stage heart failure

Szczechowicz¹,

Oßwald

Rad

et al. 2021

Int J Artif Organs

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Background: There is an ongoing debate about the influence of the female gender on postoperative outcomes after durable left ventricular assist device (LVAD) implantation. Despite the differences in pathophysiology of heart failure in females, therapy concepts are the same as in the male population. The aim of this study was to investigate the role of the female gender in surgical heart failure therapy. Materials and methods: Between August 2010 and January 2020, 207 patients were treated with durable LVAD at out institution. We matched 111 patients in two groups to compare the outcomes in male and female patients and to stratify the risk factors of mortality. Results: The groups were matched 2:1 and were comparable after matching. We found no difference in in-hospital and follow-up mortality between male and female patients. Postoperative adverse events and complications were found to be unvaried across male and female patients. Female patients had higher rates of postoperative LVAD-thrombosis compared to their male counterparts (13.5% vs 0, p = 0.001) and the rates of renal replacement therapy lasting over 90 days were also higher in the female group (33.8% vs 56.8%, p = 0.021). Furthermore, the female gender was not an independent predictor neither of in-hospital nor follow-up mortality. Conclusions: Durable continuous flow left ventricular assist devices as a bridge to transplantation or recovery in female patients are associated with a higher risk of acute kidney injury requiring RRT and are at a higher risk of LVAD-thrombosis. Nevertheless, survival rates between genders are similar.

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Sex Differences in Patients Receiving Left Ventricular Assist Devices for End-Stage Heart Failure

Cited by 42 publications

References 31 publications

Sex Differences in Recovery and Device Replacement After Left Ventricular Assist Device Implantation as Destination Therapy

Sex Differences in Recovery and Device Replacement After Left Ventricular Assist Device Implantation as Destination Therapy

Impact of Race on Clinical Outcomes After Implantation With a Fully Magnetically Levitated Left Ventricular Assist Device: An Analysis From the MOMENTUM 3 Trial

Impact of gender in patients with continuous-flow left ventricular assist device therapy in end-stage heart failure

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