Gender differences and outcomes in left ventricular assist device support: The European Registry for Patients with Mechanical Circulatory Support

doi:10.1016/j.healun.2017.06.016

The Journal of Heart and Lung Transplantation

Volume 37, Issue 1, January 2018, Pages 61-70

https://doi.org/10.1016/j.healun.2017.06.016 Get rights and content

Background

Despite the increasing use of ventricular assist devices (VADs), gender differences in indications, hemodynamics, and outcome are not well understood. We examined gender differences and gender-specific predictors for perioperative outcome in patients on ventricular support.

Methods

Multicenter data of 966 patients (median age 55 years, 151 women) from the European Registry for Patients with Mechanical Circulatory Support (EUROMACS) were analyzed. Median follow-up was 1.26 years.

Results

At the time of VAD implantation, women were more often in an unstable condition (Interagency Registry for Mechanically Assisted Circulatory Support [INTERMACS] profile 1 and 2) (51.7% vs 41.6% in men), experiencing significantly more often major bleeding (p = 0.0012), arrhythmias (p = 0.022), and right ventricular (RV) failure (p < 0.001) with need for additional RV support. The survival of women on isolated LVAD support was significantly worse (1-year survival 75.5% vs 83.2% in men). Age-adjusted Cox regression analyses showed significant associations with mortality for preoperative inotropic therapy, percutaneous mechanical support, INTERMACS profile 1 and 2, RV dysfunction, major bleeding, cerebral bleeding, ischemic stroke, and RV failure. In women, pump thrombosis was more strongly related with mortality compared to men, while the direction of the association of renal dysfunction with mortality was different for women and men (p-value interaction 0.028 and 0.023, respectively).

Conclusions

Women and men differ in perioperative hemodynamics, adverse events, and mortality after VAD implantation. A gender-dependent association of pump thrombosis with mortality was seen. The impact on treatment practice needs to be shown.

Section snippets

Study population

Between January 2011 and June 2014, 966 patients were prospectively enrolled into EUROMACS, an online database collecting anonymized data of demographics, device implantation, and long-term follow-up of patients with ventricular support.¹⁰ At the present time, more than 50 European and non-European centers from 15 countries are involved. Preimplantation data regarding patient characteristics, social situation, HF medication at admission, preoperative blood values, primary cardiac diagnosis, and

Gender-specific preoperative characteristics

Selected baseline characteristics of the study sample are presented in Table 1 (for further baseline characteristics see Table S1a; missing value information is provided in Table S1b, available in the online version of this article at www.jhltonline.org). Patients (n = 966) (median age 55 years, 151 [15.6%] women, 84% European origin) underwent primary ventricular support (LVAD, n = 790; BIVAD, n = 52; LVAD with temporary RVAD, n = 99; isolated RVAD, n = 10; total artificial heart, n = 15).

Discussion

We demonstrated significant gender differences not only in the perioperative period but also in the long-term course after VAD implantation. Women were shown to receive less VAD support despite a more critical HF state at admission. Both genders differed for implanted device types with implantation of smaller device pumps in women. Women required temporary or permanent RV support more often due to a higher incidence of RV failure. Overall survival in women was significantly worse.

In contrast to

Disclosure statement

H.R. is a consultant for HeartWare. None of the other authors has a financial relationship with a commercial entity that has an interest in the subject of the presented manuscript or other conflicts of interest to disclose.

EUROMACS is a committee of the European Association of Cardiothoracic Surgery (EACTS). Its foundation was financially supported by “Friede Springer Herzstiftung.”

We thank Roland Hetzer and Jan Gummert and the 15 other founding international members for their initiative in

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¹: These authors have contributed equally to this work.

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MCS REGISTRY in ADULTS – EUROMACS, JMACS, and INTERMACSGender differences and outcomes in left ventricular assist device support: The European Registry for Patients with Mechanical Circulatory Support

Background

Methods

Results

Conclusions

Section snippets

Study population

Gender-specific preoperative characteristics

Discussion

Disclosure statement

J Thorac Cardiovasc Surg

J Heart Lung Transplant

J Heart Lung Transplant

Ann Thorac Surg

J Heart Lung Transplant

J Heart Lung Transplant

Am J Cardiol

J Am Coll Cardiol

J Heart Lung Transplant

JACC Heart Fail

J Heart Lung Transplant

MCS REGISTRY in ADULTS – EUROMACS, JMACS, and INTERMACS
Gender differences and outcomes in left ventricular assist device support: The European Registry for Patients with Mechanical Circulatory Support