Cardiovascular Perspective

Sex Differences in the Care of Patients With Advanced

Heart Failure
Jennifer L. Cook, MD; Kathleen L. Grady, PhD; Monica Colvin, MD, MS;
Susan M. Joseph, MD; Meredith A. Brisco, MD, MSCE, Mary Norine Walsh, MD;
for the genVAD Working Group

he patient was a frail-appearing woman slumped in a wheelchair, surrounded by her 3 children. Her head tilted slightly
in greeting, but beyond her rapid and deep respiratory effort,
she was too weak to move. She had been discharged 3 days
previously from an outside hospital where she was confined for
3 weeks and had arrived at the academic medical center for a
posthospital visit. The recent admission followed 4 others in
the previous 6 months. Now, she was living at home in hospice
care. The family arrived that day hoping that, as they heard from
a church friend, the heart failure (HF) specialist might be able to
help. The patient was more accepting, saying, The doctors told
me that I am dying, and there is nothing that they can do. I am
at peace; I dont want to be a bother to no one.
There are 5.7 million patients with HF in the United States
over half of whom are women. Each year 33700 women will
die from this disease, representing 58% of all annual HF
deaths.13 Although women and men are equally likely to have
HF, women are more likely to die from it. Despite these facts,
many Americans think that men are at greater risk for heart
disease and that women are more likely to die from breast
cancer.
Why is the risk of HF in women underappreciated? The substantial numbers of women with HF with preserved ejection
fraction (HFpEF) may be a contributor. It is known that HF with
reduced EF (HFrEF) accounts for only a portion of patients
with symptomatic HF. In a cohort of patients from Olmsted
County, MN, HFrEF accounted for only 57% of patients with
HF, whereas 43% of patients had an ejection fraction of >50%.
Patients with HFpEF were more likely women (69%) and
almost half of them were above the age of 80.4 Subsequent
surveys have also demonstrated an increased frequency of
HFpEF in women compared with men where women comprise
between 71% and 75% of patients with HFpEF.5,6

HF Mortality

diagnosed with HF have higher expected survival than men.7

This has been recently challenged as it has been pointed
out that these cohorts included both patients with HFpEF
and patients with HFrEF. In the Studies of Left Ventricular
Dysfunction (SOLVD) clinical trial, men and women aged
between 21 and 80 years with an EF of <35% and symptomatic HF received enalapril versus placebo. In this cohort,
women had a greater 1-year mortality rate, 22% when compared with 17% in men (P=0.05). This may better represent
sex differences in mortality in HFrEF.7 The SOLVD patient
population differed from previous epidemiological studies because an assessment of left ventricular function was
required on entry. It is thus probable that women followed
in the earlier epidemiological studies, with diagnosis of congestive heart failure being made on symptoms without an
assessment of left ventricular function, had a higher incidence of diastolic dysfunction. This may account for their
demonstrated survival advantage. In addition, women in
SOLVD had a higher incidence of coronary disease than did
the women in Framingham or NHANES-1,7 which may have
contributed to their worse prognosis.
Both women and men with HFrEF who have advanced
symptoms benefit from evaluation by an advanced HF specialist for consideration of therapy, such as mechanical circulatory support (MCS) and cardiac transplantation. As symptoms
worsen, physical disability sets in and hospital admissions
mount, and their lives may depend on it. However, referral
of appropriate patients is underused in both men and women
with HFrEF.8 Certain clinical indicators signify increased
mortality risk, such as low New York Heart Association functional class, intolerance to evidence-based HF. Women with
HF face a greater uphill battle because they are less likely than
men to be referred for cardiology specialist management and
are more commonly managed by their primary care physician
despite the severity of their symptoms.7

It may be perceived that women with HF have a lower risk

of mortality compared with men. Epidemiological studies,
including National Health and Nutrition Examination Survey (NHANES-1) and Framingham, reported that women

Cardiac transplantation is currently the most successful therapy for selected patients with end-stage HF. Each year, 2200

Cardiac Transplantation

From the Cardiovascular Division, Medical University of South Carolina, Charleston (J.L.C., M.A.B.); Division of Cardiac Surgery, Northwestern
University, Chicago, IL (K.L.G.); Cardiovascular Division, University of Michigan, Ann Arbor (M.C.); Cardiovascular Division, Washington University,
St. Louis, MO (S.M.J.); and St. Vincents Heart Center of Indiana, Indianapolis (M.N.W.).
Correspondence to Jennifer L. Cook, MD, Medicine Heart Failure and Transplantation, Left Ventricular Assist Device Program, Medical University of
South Carolina, 114 Doughty St, MSC 592, Charleston, SC 29425. E-mail cookjen@musc.edu
(Circ Cardiovasc Qual Outcomes. 2015;8:00-00. DOI: 10.1161/CIRCOUTCOMES.115.001730.)
2015 American Heart Association, Inc.
Circ Cardiovasc Qual Outcomes is available at http://circoutcomes.ahajournals.org

DOI: 10.1161/CIRCOUTCOMES.115.001730

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1

2 Circ Cardiovasc Qual Outcomes March 2015

heart transplants are performed in the United States with the
major limitation to broader use being inadequate donor supply.
Women represent between 19% and 27% of annual adult heart
transplant recipients.9 Data from the Scientific Registry of
Transplant Recipients demonstrate that of the 2143 adults who
underwent heart transplantation in 2013, 27% were women.10
The proportion of female recipients has been rising steadily,
increasing by 27% between 2008 and 2013, compared with
only a 12% increase in men during the same period.10
Adult female transplant recipients tend to be younger than
men. In 2014, 37% of the women who underwent transplantation in the United States were <50 years of age compared
with 26% of the men. Of the 380 recipients who were 65
years of age, 16% were women compared with 22% men.10
These trends may be related to known sex differences in the
causes of HF; however, as with other types of cardiovascular disease, questions on sex-specific differences in recognition, referral, and refusal on the part of the patient arise.11,12
Furthermore, transplant stability, donor availability, and transplant outcomes may be affected by immunologic challenges
and sensitization, which are more prevalent in women because
of pregnancy.13

Mechanical Circulatory Support

Because of the limitations of heart transplantation, MCS
has emerged as an alternative treatment for end-stage HF.
Unlike early ventricular assist devices (VADs) that required
confinement in the intensive care unit, currently used VADs
are fully implantable and are powered by an external battery
source. The VAD allows patients with end-stage HF to return
home and resume normal activities while on support. VADs
are used in 2 different scenarios; in patients who are awaiting heart transplantation (bridge-to-transplant [BTT]) and
as final (or destination) therapy for those ineligible for heart
transplantation.
Early on, application of VAD technology was limited by the
large size of the pump (3.74 pounds) allowing for implantation only for patients with a body surface area (BSA) >1.5 m2.
Because women generally have a smaller BSA and weight,
it is not surprising that the early clinical trials only enrolled
22% women.14 With technological advances, however, VADs
have become smaller and more durable. Because of decreased
adverse events and positive outcomes, VADs are increasingly
being implanted permanently (ie, as destination therapy).15
Despite the smaller size of newer VADs, women continue to
receive fewer VADs than men and remain under-represented
in clinical trials. In the HeartMate II BTT trial, only 22%
of patients were women,16 and in the HeartWare Ventricular
Assist Device (HVAD) ADVANCE BTT trial, only 28% of
patients were women.17 In the HeartMate II destination therapy trial, there were 19% women in the treatment arm and 8%
in the control arm.18
Outside of clinical trial experience, all patients receiving Federal Drug Administrationpostapproved VADs are
included in a national registry that is designed to evaluate outcomes in MCS. The Interagency Registry for Mechanically
Assisted Circulatory Support (INTERMACS) provides
a more contemporary look at the use of VADs. Among the
INTRERMACS cohort from June 2006 until March 2010,

only 21% were women,19 and they were more likely to get
the newer, smaller device compared with the older, larger one.

Outcomes of MCS
Differential outcomes may be posited to explain why women
are less likely than men to receive VADs, but this is not the
case. Women have an equal survival benefit compared with
men after VAD implantation. In the HeartMate II BTT trial,
survival was similar for men and women. Men were more
likely to be successfully bridged to transplant (M=55% and
W=40%; P=0.001), and therefore, not surprisingly, women
were supported for a longer period of time (M=184 versus W=238 days; P=0.003). In the HeartMate II BTT trial,
adverse events were similar with the exception of hemorrhagic stroke (M=0.01 versus W=0.04 events per patient
years; P=0.02) that occurred more frequently and device
related infection (M=0.44 versus W=0.23; P=0.006) that
occurred less frequently in women.20 These results are also
supported by a single-center study, wherein sex-specific BTT
survival was no different at 1, 6, 12, and 24 months after
implantation.21
In the ADVANCE HVAD BTT trial, as well as the Continued
Access Protocol, after adjustment for baseline differences,
there was no sex difference in survival at baseline, 180 days,
or 1 year. Women enrolled had a smaller BSA (1.80.2 versus
2.10.3; P<0.0001) area, less hypertension, and less ischemic
cause. At baseline, they were also more likely to have right
ventricular failure (increased creatinine and bilirubin), systolic HF, diastolic HF, mean arterial pressure, and pulmonary
artery pressure. After implantation, women had similar rates
of most adverse events (including hemorrhagic stroke); however, they had increased risk of renal dysfunction and right
HF, and they were in need of a right VAD. In this trial, women
had more intensive care unit days and a longer total hospital
length of stay.22
INTERMACS data demonstrates no sex differences in
mortality for pulsatile (P=0.82) or continuous flow (P=0.95)
devices. Compared with men, women were younger, less
likely to be married and had a lower BSA (1.91 versus 2.14;
P<0.0001). Interestingly, women tended to be implanted
when they were more severely ill, later in the course of their
disease.19

Quality of Life Improvements After

Transplantation and MCS
Women experience gains in health-related quality of life
(HRQOL) after surgery for advanced HF. In the first year after
left ventricular assist device implantation, improvement in
HRQOL is seen in both women and men. Women are known,
however, to experience more problems with usual activities,
anxiety, depression, and pain than men early after implantation.20,23 These observations are also seen within the first
year after heart transplantation, wherein both groups experience gains in HRQOL; but again, women have more physical functional disability, anxiety, and depression than men.24,25
These differences in HRQOL persist >1 year after transplantation.2629 Differences in long-term HRQOL after MCS are not
known.

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Cook et al Sex Differences in Advanced Heart Failure 3

There are also differences in the perception of support by
men and women, which may influence HRQOL and other outcomes. There is much to learn about differences in support, as
perceived by men versus women, who undergo left ventricular
assist device implantation. Findings from the transplant literature may be informative. More satisfaction with social support is related to better HRQOL after heart transplantation,30
and men have reported more satisfaction with long-term
social support after transplantation than women.31 In addition,
in a recent European study, support by women of their male
spouses who underwent organ transplantation was related to
intent to adhere to medication, but the reverse was not true.32
These findings may have relevance for women who undergo
MCS implantation. There is a clear need to better understand
perception of support by women who undergo MCS implantation, as women more typically provide support to their chronically ill male spouses,33 rather than receive support.

Patient Selection and Acceptance

Thus, women are a minority of recipients of VADs and heart
transplants, despite findings that they too experience improved
outcomes, including survival and HRQOL. To assess the possibility of sex disparities in the heart transplant selection process. Aaronson et al11 reported the results of the evaluations
of 386 patients being considered for heart transplantation.
In spite of being similar to men in regard to age, New York
Heart Association Class, duration of HF, left ventricular ejection fraction, cardiac index, higher pulmonary artery wedge
pressure, and lower peak oxygen consumption, women were
less likely to be listed for transplantation. Women were more
likely to be nonwhite, have nonischemic cardiomyopathy, and
have a history of substance abuse. Remarkably, the primary
reason why women were not deemed acceptable candidates
was because of patient refusal. Why do women take themselves out of the game? What factors lead to their choosing
optimal medical therapy compared with advanced surgical
therapy? Women were more likely to be in the lowest quartile for income (38% versus 22% in men; P=0.01), and lower
income was independently associated with nonacceptance for
transplantation.

Conclusions
The patient described was admitted to the hospital and evaluated for a VAD. She elected to undergo VAD implantation and
lived for an additional 4.5 years. It is clear that women are
equally as likely as men to have HF, but they are more likely
to die from it. Furthermore, they are equally likely to benefit
from advanced therapies, including heart transplant and left
ventricular assist device. Despite this, women are less likely
to be referred for these therapies and if referred, receive them
at a later stage. Although the number of heart transplants in
women has increased over the past 25 years, only a quarter
of recipients are women. Technological advances in MCS
that have allowed for patients with smaller BSA to be eligible
for implantation have not changed the percentage of women
receiving VADs.
It is imperative that we seek to understand these sex differences in delivery of advanced HF therapy. Although current

data may suggest under-referral and rejection of therapy by

women, factors, such as misperception about body size limitations and body image, may also influence the decision to
implant a VAD. Speculation, however, is inadequate to draw
conclusions. What is needed are inclusive, adequately powered trials, examining existing data, and using anecdote as a
springboard for scientific investigation. Looking toward the
future, it is anticipated that the HF prevalence and, therefore,
the rate of mortality will continue to rise.1 Here, we identify
potential disparity in care and call for these unmet needs of
women to be addressed. In the field of advanced HF, we must
work together to provide a longer and better quality of life for
our mothers, daughters, and ourselves.

Disclosures
Dr Cook is an advisory board member of Abiomed. Dr Joseph reports
minor speaking honoraria from Thoratec and she is an advisory board
member of HeartWare. The other authors report no conflicts.

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Key Words:healthcare disparities heart failure heart-assist device

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Sex Differences in the Care of Patients With Advanced Heart Failure

Jennifer L. Cook, Kathleen L. Grady, Monica Colvin, Susan M. Joseph, Meredith A. Brisco and
Mary Norine Walsh
for the genVAD Working Group
Circ Cardiovasc Qual Outcomes. published online February 24, 2015;
Circulation: Cardiovascular Quality and Outcomes is published by the American Heart Association, 7272
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