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Cardiovascular Perspective
Challenge of Informing Patient Decision Making
What Can We Tell Patients Considering Long-Term Mechanical
Circulatory Support About Outcomes, Daily Life, and End-of-Life Issues?
Lucy J. Boothroyd, PhD; Laurie J. Lambert, PhD; Anique Ducharme, MD, MSc;
Jason R. Guertin, MSc; Georgeta Sas, MD, MSc; Éric Charbonneau, MD; Michel Carrier, MD;
Renzo Cecere, MD; Jean E. Morin, MD; Peter Bogaty, MD
Background
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to transplantation, we do not consider in this perspective the
other clinical recourses to MCS (rescue therapy and bridge
to decision) where circumstances may make the informed
­decision-making process particularly problematic. Our work
is aimed at not only specialists in the field but also the general cardiology audience that may not be familiar with this
specialized literature. Our methods included a search of the
peer-reviewed scientific literature published in English or
­
French from January 2000 to the end of December 2012,
using the PubMed bibliographic database and key words
and reference lists of retrieved documents. We consulted
primary research articles and consensus scientific statements, expert opinion editorials, and review articles. The
most recent clinical practice guidelines concerning MCS by
the International Society for Heart and Lung Transplantation
and the most recent annual report of the Interagency Registry
for Mechanically Assisted Circulatory Support, at the time of
our review, were also consulted. We extracted data on outcomes from all empirical studies of DT patients who received
HeartMate II (the implantable device currently most often
used for DT) and that were published since 2008 (the year in
which the device was approved for DT in the United States).
We also extracted data from all empirical studies that involved
≥1 DT patients (or informal caregiver of a DT patient) on living with MCS, providing care to a recipient, or terminating
MCS. For studies with mixed patient populations, information specific to DT patients was extracted whenever possible.
An independent committee of clinical experts (1 cardiologist
[A.D.] and 3 cardiac surgeons [É.C., M.C., R.C.]), active in
the MCS domain, assisted with the interpretation of results.
In the management of advanced heart failure, the option of
long-term mechanical circulatory support (MCS) as destination therapy (DT), rather than as a temporary bridge to cardiac
transplantation, is increasingly being offered to highly selected
patients. Recent technological advancements in implantable
devices, such as continuous flow systems and smaller pump
sizes, have increased the possibility of survival with fewer
complications. Informed consent before MCS is essential1–6
and is a fundamental aspect of patient-centered care. As a part
of a quality decision-making process, the patient considering
MCS and his/her informal caregiver(s) need to be aware of
the current state of the scientific evidence, including what is
known and unknown about outcomes and living with MCS
and must navigate a series of interactions with clinicians
before deciding on the treatment course.
Editorial see p 13
The Institut National d’Excellence en Santé et en Services
Sociaux is a health technology assessment and clinical
guideline development organization in the province of
Quebec (Canada) that provides multiple stakeholders (ie,
government officials, hospital administrators, physicians,
and patient organizations) with evidence-based information. In 2011, the Quebec Ministry of Health requested that
the Institut National d’Excellence en Santé et en Services
Sociaux provide recommendations on the use of implantable
left ventricular assist devices in end-stage chronic heart failure. The current article extends the work submitted to the
Ministry1 and focuses on MCS use in DT, within the framework of informed decision making.
In this perspective piece, we report on our review of the
scientific literature concerning clinical outcomes in DT and
on perspectives of DT patients and their caregivers, to provide a summary of currently available information and identify gaps in knowledge. Besides the use of MCS as a bridge
Framework: Informed Decision Making
Informed decision making is an ethical norm and legal mandate, which refers to the voluntary choosing of an intervention (or of no intervention) by a patient, or by his/her
­decision-making proxy, in light of ongoing discussion with
From the Institut National d’Excellence en Santé et en Services Sociaux, Montreal, Quebec, Canada (L.J.B., L.J.L., J.R.G., G.S., J.E.M., P.B.); Institut
de Cardiologie de Montréal, Montreal, Quebec, Canada (A.D., M.C.); Centre de Recherche du Centre Hospitalier de l’Université de Montréal, Montreal,
Quebec, Canada (J.R.G.); Institut Universitaire de Cardiologie et Pneumologie de Québec, Quebec, Canada (É.C., P.B.); and McGill University Health
Centre, Montreal, Quebec, Canada (R.C., J.E.M.).
The Data Supplement is available at http://circoutcomes.ahajournals.org/lookup/suppl/doi:10.1161/CIRCOUTCOMES.113.000243/-/DC1.
Correspondence to Lucy J. Boothroyd, PhD, INESSS, 2021 Union Ave, Suite 10.083, Montreal, Quebec H3A 2S9, Canada. E-mail lucy.boothroyd@
inesss.qc.ca
(Circ Cardiovasc Qual Outcomes. 2014;7:179-187.)
© 2014 American Heart Association, Inc.
Circ Cardiovasc Qual Outcomes is available at http://circoutcomes.ahajournals.org
179
DOI: 10.1161/CIRCOUTCOMES.113.000243
180 Circ Cardiovasc Qual Outcomes January 2014
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the physician about treatment options and their respective
benefits and risks.4,5,7 It is viewed as “an exchange of ideas
that buttresses the physician–patient relationship.”7 The Figure summarizes the central elements of an informed decisionmaking process concerning MCS, grouped by topic. The
process should ideally be (1) patient-centered, (2) timely,
(3) comprehensive, (4) bidirectional (patient↔care providers), (5) multidisciplinary, (6) ongoing, and (7) responsive to
changes in situation and preferences. In addition to receiving
information about the reported clinical outcomes of long-term
MCS,2–6,8 specific to the device being offered, we think that
to be fully informed, the patient should also be made aware
of the limitations of current scientific evidence2 and be given
some sense of how similar patients in the literature are to him
or herself. The information should be based on the best available evidence and appropriately collected, summarized, and
appraised. Importantly, this information should be made comprehensible to a lay audience.
We believe 3 important considerations pertain to the framing
of the patient–clinician discussion about long-term MCS: (1)
in advanced heart failure, as in other areas of medicine, there
is inherent uncertainty on a patient’s specific course; (2) MCS
may be the only option left to the patient to extend his/her life
(although in some settings the patient considering MCS as DT
may be less sick); and (3) the extent to which patients and their
informal caregivers will be able to absorb information and
grasp details about clinical outcomes and research findings can
Figure. Key elements of the informed decision making process in
­long-term MCS.2–6,8 DT indicates destination therapy; and MCS,
mechanical circulatory support.
be highly variable given the gravity of a patient’s condition, the
circumstances in which the discussions take place, and differing degrees of patient and caregiver comprehension.
Anticipated Benefits and Risks of MCS
From a total of 831 citations identified by our literature search,
we retained 7 articles that addressed this theme, representing
an evidence base of a maximum of ≈2000 DT patients. Five
articles concerned clinical research studies: a multi-center
randomized controlled trial,9 a multi-center continued protocol access case series following the trial,10 an analysis of
data from these first 2 studies,11 a case series from a single
center that participated in the first 2 studies,12 and a multicenter investigation of neurocognitive function on a subset of
the trial patients.13 Two articles presented data from the Interagency Registry for Mechanically Assisted Circulatory Support in the United States from June 23, 2006, to June 30, 2012
(114 centers),14 and to December 31, 2011 (specific to DT).15
The registry did not include the patients enrolled in the trial or
the continued access series.
Overall, the average age of DT patients in the literature was
≈63 years, and the majority (80%) of patients in the research
studies were men. Before MCS in the research studies, most
patients (66%) were in New York Heart Association class
IV (heart failure symptoms were experienced even at rest),
64% were not ambulatory, and 75% were receiving intravenous inotropic therapy. Before MCS, ≈75% of registry DT
patients were in 1 of the 3 most severe Interagency Registry
for Mechanically Assisted Circulatory Support profile levels,
indicating their hemodynamic status: 11% critical cardiogenic
shock (level 1), 38% progressive decline (level 2), and 30%
stable but inotrope-dependent (level 3). The research studies
specify that the median duration of MCS was 1.7 to 2.1 years
(minimum <1 month, maximum 6 years).
Table 1 summarizes the results with respect to clinical outcomes documented in the literature (What We Know column).
We also summarize limitations and missing elements (What
We Do Not Know column). In Table I in the Data Supplement,
the number of persons with data is specified for each outcome,
and details about study patients are provided.
Table 1 shows that survival, functional capacity, end-organ
function, and quality-of-life results are favorable in the published literature. Based on the most recent available data, DT
patients have shown a 75% chance of surviving for 1 year and
a 66% chance of surviving for 2 years.10,15 The patient considering DT needs to understand that there is a certain level of
uncertainty surrounding study-based estimates. For individualized assessment of expected survival whether the patient
accepts or declines MCS, the clinician considers patient risk
factors such as age, clinical status (including Interagency
Registry for Mechanically Assisted Circulatory Support profile level, renal dysfunction, and right ventricular function),
the patient’s unique psychosocial profile, medical history,
medication intolerance, and the complexity of the surgical
procedure(s) being considered.2,14,19,20 Risk models are used to
help assess likelihood of survival,19 as well as the likelihood
of complications during MCS for an individual patient,21,22 but
are likewise associated with uncertainity2 (a review of these
is beyond the scope of this perspective). Moreover, the value
Boothroyd et al Informing Patients About Cardiac Assist Devices 181
Table 1. Clinical Outcomes for DT Patients
What We Know
What We Do Not Know
Survival*
No published information beyond 2 y
After 1 y, about three fourths of recipients were alive on support
(most recent data).10,14 After 2 y, about two thirds of recipients
were alive10,14
Limited numbers of patients with 2-y data: 100–150 persons
for NYHA class, 6-minute walk distance, activity level, time
spent readmitted, adverse events; <50 patients for end-organ
function
NYHA class
No published information on other important end-organ function
(hepatic, renal)
Before implantation, 0% of patients in class I/II; at 6 mo, this figure
was 80%9,10 (a change of 1 class is considered important).16
Same result after 2 y9,10
For functional, end-organ, and quality-of-life tests, results
(and patients’ features) not known for those who could not
be evaluated
6-minute walk distance
Before implantation, ambulatory patients could walk an average
of ≈200 m.9,10 At 6 mo, this figure was >340 m9,10 (>100 m farther;
25 m farther is considered important).16 Same result at 2 y9,10
We do not know whether research study participants do better, or
worse, than other DT patients
Activity level†
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Before implantation, 4% of patients could perform moderate to
very high activity. At 6 mo, this figure was 62%11 (a change of
1 activity level is considered important).16 Same result at 2 y11
End-organ function
Compared with before implantation, recipients had stable or
improved neurocognition‡ at 6 mo using standardized tests.13
Same result at 2 y13
Quality of life§
Based on standardized tests and compared with scores before
implantation, recipients showed improvements in overall quality
of life scores at 6 mo that are considered important in real life.9,10,14
Same results at 19,10,14 and 2 y9,10
Initial hospitalization
After the implantation procedure, 50% of patients spent ≥23 days
in hospital.10 A total of 87% of patients were discharged9,10
No information about either the range in length of the
initial hospitalization or the features of those who were
not discharged
Hospital readmissions during support
No information on how many patients have ≥1 readmission
A total of 81% were readmitted at least once for an average of
8 days/patient per year12
No information about the outcomes for those who had
repeated readmissions
Per patient there were 0.4–2.3 readmissions/y12
No information about the range (in days) in length of
support time in hospital
Primary causes: bleeding (30% of readmissions); cardiac-related (24%);
infection (14%); thrombosis (7%); major neurological event (6%);
liver-related (4%); pump alarm or abnormal readout (3%)12
Recipients spent 12% of support time in hospital9
Adverse events during support
Categories are nonexclusive
Percentage of recipients affected (most recent data10):
Bleeding, transfusion║,¶
74
Renal failure║
11
Cardiac arrhythmias#
50
Pump replacement
8
Local infection
45
Ischemic stroke
8
Sepsis
28
Pump pocket infection
7
Respiratory failure║
38
RVAD required║
6
Device-related infection
30
Pump thrombosis
6
Driveline infection
27
Hemorrhagic stroke
5
Bleeding requiring surgery║
20
Hemolysis
5
Right heart failure║
21
Hepatic dysfunction
29
Other neurological**
17
9
No information about either the length of hospital stay
(if any) related to complications or impact on patient
quality of life
We do not know whether research study participants do better
or worse than other DT patients in terms of adverse events
(Continued )
182 Circ Cardiovasc Qual Outcomes January 2014
Table 1. Continued
What We Know
What We Do Not Know
Percentage of recipients readmitted to hospital for event12:
Cardiac problem‡‡
38
Major neurological event##
Bleeding§§
36
Alarm/readout
14
7
Infection║║
23
Biliary problem
6
Thrombosis¶¶
14
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DT indicates destination therapy; NYHA, New York Heart Association; and RVAD, right ventricular assist device.
*Kaplan–Meier estimates with censoring at any left ventricular assist device explantation.
†Patient-reported exercise ability. Highest level of activity varied from very low (eg, bedridden; unable to care for self; no physical activity) to moderate (eg, casual
walking speed; gardening; vacuuming; golfing; wall painting) to very high (eg, dancing; climbing stairs; rapid stationary cycling; heavy shoveling).
‡Stable results if normal at baseline; improved function if abnormal. Tests included visual/spatial perception, memory, executive functions, language, and processing
speed.
§Tests specific to heart failure: Kansas City Cardiomyopathy Questionnaire, Minnesota Living With Heart Failure Questionnaire; scores improved by ≥30 points (≥5 is
considered important).16 General tests: EQ-5D questionnaire, EQ-5D visual analogue scale.
║Occurs more often in first 30 days of support, according to temporal data from patients on bridge to transplantation.17,18
¶Requiring packed blood cells.
#Requiring cardioversion or defibrillation.
**Including transient ischemic attack, seizures, and confusion.
‡‡Arrhythmia, heart failure, or chest pain.
§§Any bleeding, anemia.
║║Device-related or unrelated.
¶¶Thromboembolism, suspected device thrombosis.
##Cerebrovascular accident or intracranial bleed.
given to survival estimates on MCS will vary as a function of
the importance each patient assigns to the possibility of living
longer, and better (see below), and the price the patient is willing to pay in terms of constraints and potential complications.
Current data estimate that 80% of tested left ventricular assist device recipients had no or only slight activity
limitations at 2 years after implantation (ie, New York Heart
Association class I or II symptoms).9,10 The patients who
were tested before implantation were in New York Heart
Association class III (30% of patients) or class IV (70%).9,10
Patients who were ambulatory before receiving MCS became
able to walk an average of >340 m in 6 minutes (ie, the length
of 3 football fields) 2 years later.9,10 Sixty percent of recipients
could perform at least moderate if not more strenuous activities at 2 years (eg, walking at a casual speed, light gardening,
or housekeeping); only 4% reported such activity levels before
implantation.11 Tested patients reported significantly improved
quality of life at 2 years compared with before MCS.9,10 Impact
on quality of life, rather than only survival, is central to the
decision-making process for a patient considering DT.4,9,23,24
However, it is at present difficult to predict whether functional
and quality-of-life benefits are likely to be experienced by the
individual patient,21 and the postoperative course (including
the possible development of complications) is uncertain.
Table 1 shows that adverse events during left ventricular
assist device support are common, and many are life-ending or
life-altering (eg, stroke). Based on the most recent article that
provides data in terms of the number of patients affected,10
74% of DT patients had bleeding that required a transfusion
(≥2 U of red blood cells within 24 hours), 50% had an arrhythmia requiring cardioversion or defibrillation, and at least 27%
developed a device-related or blood-borne infection requiring
antimicrobial therapy. Although bleeding requiring surgery or
transfusion was much more frequent in the first 30 days after
implantation, arrhythmias and infections could occur throughout MCS (based on temporal data from bridge to transplantation MCS patients). The most frequent infections related to a
device component were those involving the driveline exiting
the body; most infections of this type occur after the first 30
days of support. Ischemic stroke affected 8%, hemorrhagic
stroke affected 5%, and 8% had their pump replaced. In the
first 6 months after implantation, readmissions for complications were most often the result of bleeding and cardiac problems (arrhythmia, heart failure, or chest pain).12
Besides the complexity of individualized risk assessment,
the main limitations of the findings on clinical outcomes
include the paucity of data >2 years of support. Even during
the first 2 years, relatively small numbers of patients provide
data for some outcomes (eg, neurocognition). These are critical points because DT is by definition intended as long-term
support. The possibility that the results are biased toward
patients doing better should also be considered because not
everyone could be tested at all time points for all outcomes.
Expectations for Daily Life
Patients using MCS must maintain regular contact with the
MCS team, travel to medical appointments, undergo frequent
clinical tests, manage equipment (eg, tend to dressings, respond
to alarms, change batteries, perform system tests, and protect
parts from moisture), and continue to adhere to a strict medication regimen.25,26 Adaptation of lifestyle is required,3,25,27 and
availability of social support is essential.3,5,26 As another part of
the informed decision-making process, therefore, the patient
considering DT requires information on what to expect in
daily life on MCS.4 Meeting and being able to exchange with
a patient already on MCS can be most helpful.
From a total of 108 citations identified by our literature
search, we retained 7 articles that examined this theme.28–34
Boothroyd et al Informing Patients About Cardiac Assist Devices 183
Although multiple domains of life were addressed, this literature was limited: studies had small sample sizes (5–15 persons), all took place at single sites, and 5 studies were from
the same institution in the United States. Information specific
to DT patients or their informal caregivers were almost always
lacking because 6 study samples also included patients who
received MCS for other indications (notably MCS as a bridge
to cardiac transplantation). For most of the results presented
below (unless otherwise indicated), ≈20% of study participants received DT. Patients varied in age from 31 to 76 years,
and caregivers were 39 to 71 years of age. Eight-five percent
of patients were men; all caregivers were women. Results and
their limitations are summarized in Table 2, whereas details on
the evidence base for each outcome are provided in Table II in
the Data Supplement.
The studies show that life on MCS required major adjustment
for both patients and their caregivers, and that the early experience could be frightening and overwhelming.28–30 Despite a
new lease on life offered by the treatment, MCS affected multiple aspects of life, including hygiene, sleep, the environment,
daily routines, and personal and intimate relationships.28,31 An
initial adjustment period of ≈3 months was difficult for both
MCS recipients and informal caregivers.28,30 Informal caregivers, who described caregiving as a 24/7 responsibility, settled
into their role and new lifestyle with time.28,30 Most MCS
recipients reported being satisfied with intimate relations after
implantation, after various adaptations and self-care behaviors
Table 2. Patient/Caregiver Perspectives on Daily Life With MCS
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What We Know
What We Do Not Know
Lifestyle adaptation
28,29
Adjustment took time
Poor quality of life and major limitations before MCS
Positive feelings on MCS as well as awe, dismay, feeling overwhelmed
about care
Early adjustment involved changes in hygiene, sleep, home environment,
clothing, routines, personal relationships, socialization, and employment
Early fear, anxiety, and low self-confidence
Adjustment process difficult for many recipients
Late adjustment (after 3 mo) involved accepting a new way of living;
DT patients reported positively embracing MCS
Except for the study on psychological disorders, we do not have much
information specific to DT patients (or their caregivers) unless indicated
because the investigations include patients bridged to transplant
We do not know whether the results for recipients in these research studies
are applicable to most DT patients. For example, study participants may do
better or worse than other patients
We do not know whether the caregiving results are applicable to most
caregivers of DT patients or to male caregivers
We do not know how reproducible the results on caregiving,30 sex/intimacy,31
and psychological disorders34 are because they come from single studies
Feelings reported by recipients: facing the unknown, feeling confined
(in hospital; because of dependence on others), shame when out with the
device, overwhelming fear, and hope for the future
Despite difficulties, would accept MCS again
Adjustment to caregiving30
Caregiving a 24/7 responsibility
Feelings reported by caregivers: hyper-vigilance, less time for personal
activities, settling into role with time, adjusting was overwhelming in first 3 mo
Caregiving extended beyond technical tasks to a supportive role, requiring a new
lifestyle and coping strategies; satisfaction with caregiving developed with time
Sex and intimacy31
Improved sexual functioning after MCS
Most recipients satisfied with their sexual relations and intimacy
Adaptations and self-care behaviors used to maintain normal intimate relations
Most recipients reported partners being fearful of sex; some partners
wanted to abstain
Sleep32,33
Significant sleep disturbances before MCS and at 6 mo of support
Short sleep duration and quality before MCS and at 6 mo of support
Average total sleep time: 4.2 h before MCS and 4.6 h at 6 mo
At 6 mo, significant improvement in overall quality of life, modest
improvement in sleep quality, and daytime alertness
Psychological disorders34
Diagnoses among DT patients seen by a psychologist in the postoperative
period: adjustment disorder (47%), acute stress reaction (20%), depressive
episode (20%), panic disorder (7%), and 13% had no disorder
DT indicates destination therapy; and MCS, mechanical circulatory support.
We do not know whether patients on MCS seen by a psychologist differ from
those not seen
184 Circ Cardiovasc Qual Outcomes January 2014
were undertaken although some of their partners were fearful of sexual activity.31 Sleep disturbances were common: in a
study of 12 patients (25% DT), all displayed both short sleep
duration (average 4.5 hours) and poor sleep quality at 6 months
after implantation despite significant improvement in overall
quality of life.32,33 In a study of recipients of DT who consulted
an in-hospital psychology service in the postoperative period,
adjustment disorders affected nearly half of patients; both an
acute stress reaction and a depressive episode affected 20% of
recipients.34 These studies provide useful real-world information for DT candidates, although they may be more reflective
of recipients who are willing to participate in research studies, of particular centers, or of recipients who receive MCS as
a temporary measure (because most study participants were
actually awaiting transplantation). Finally, these studies may
represent success stories rather than mirroring all experiences.
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Device Deactivation and Other
End-of-Life Issues
Documented end-of-life care planning, in general, and explicit
discussions about device deactivation, in particular, are recommended before MCS.2–4,6,8,20 There is a consensus in American
and European position statements that patients (or their surrogate
decision makers) have the right to request active discontinuation
of MCS.2,35 This differs from assisted suicide and euthanasia
because the intent is ending a treatment that is preventing natural progression of a pre-existing disease.4,36,37 Recent position
statements highlight the importance of involving a collaborative,
multidisciplinary team in end-of-life care planning and the central role of palliative care professionals in these discussions.2,3,19,35
From a total of 108 citations identified by our literature search, we retained 5 articles pertaining to end-of-life
issues.35,38–41 This literature was very limited: studies were
small (14–68 persons), and 4 were from single sites (3 from
the same hospital). Two studies involved exclusively DT
patients. Patients varied in age from 19 to 83 years; 86% were
men. Results and their limitations are summarized in Table 3,
whereas details on the evidence base for each outcome are
provided in Table III in the Data Supplement. Table 3 lists
some examples of issues that were not addressed by the available literature that include optimal timing of discussions and
psychological effects.
The studies show that DT patients were more likely to have
documented care directives in their medical charts if they
were formally involved in advance care preparedness planning,38 and that palliative care consultations for patients using
MCS (≈60% DT) were both appreciated and associated with
increased clarity about treatment plans.38,39 A 2003 to 2009
study (≈50% DT) found that none of the care directives of
MCS patients in medical charts specifically mentioned the circumstances in which MCS might be deactivated.40 However,
requests to terminate MCS were not uncommon: at the same
center from 2003 to 2009, such requests were made for 21%
of recipients (50% of these DT), usually by surrogate decision makers (85% of the time), because the patients no longer
had decision-making capacity.35 Two studies we reviewed, one
exclusive to DT, reported that decision making about terminating MCS was facilitated by open discussions with a multidisciplinary care team and by care providers giving detailed
information about the deactivation process and palliative
treatments.35,41 Most DT patients who actively participated in
deactivation decisions had experienced a decline in quality of
life because of clinical or functional deterioration.41
Discussion
This perspective focuses on information transfer as an integral
part of the decision-making process for patients considering
long-term MCS and for whom subsequent heart transplantation is unlikely. Like the informed consent process itself, the
exchange of information between care providers and patients
should be bidirectional, timely, comprehensive, and responsive
to changes in patient preferences and clinical course. We have
summarized the current status of the scientific evidence in DT
on 3 overarching topics. Information on clinical outcomes for
DT patients is relatively plentiful. However, there is much less
scientific literature about the impact of MCS on daily life for
recipients and their informal caregivers/family. Nonetheless,
this limited literature provides valuable information on the lived
experience, including the ending of treatment. For all 3 topics,
current data apply mostly to men.20 Sex-specific analyses among
transplantation-eligible patients indicate similar clinical benefits
in women and men, but differences in risks of adverse events.42
The unknowns that we have identified included gaps in
knowledge, where information is lacking, and the applicability of findings from groups of research or registry participants to the individual patient considering MCS. For a DT
candidate with advanced heart failure, his/her own clinical
course, with or without MCS, is somewhat uncertain.2 Perhaps
the most critical gap in knowledge for DT relates to the difficulty in precisely predicting who will achieve clinical and
­quality-of-life benefits afforded by long-term MCS and who
will experience life-altering complications. There is a pressing
need for predictive models that go beyond survival to guide
patient decision making.2,24,26
Our results capture the state of the science as of early 2013.
We searched peer-reviewed scientific publications and did not
explore information available from other sources. Nevertheless,
we have combined results from multiple themes and sources
(eg, research studies, registries, and qualitative investigations). We have focused on patients considering MCS as DT
rather than other indications such as ­bridge-to-transplantation.
We appreciate that these categories are neither strictly distinct
nor always easily discernible in clinical practice.
Information transfer to patients is only 1 component of the
decision-making process.7 Other aspects are careful, individualized assessment of the patient’s clinical, social, and psychological state; the use of risk models to assist with prognosis;
and broader discussion about the goals of care.2 A scientific
statement from the American Heart Association on decision
making in advanced heart failure provides advice and tools
addressing communication and the doctor–patient relationship.2 The complexity and time-consuming nature of treatment discussions in MCS and particularly DT is recognized,
and decision aids are suggested to assist with the presentation
of numeric data (such aids are conceived as more than simple
information pamphlets; http://decisionaid.ohri.ca). Training
for physicians in communication methods and a supportive
environment for multidisciplinary, patient-centered care are
Boothroyd et al Informing Patients About Cardiac Assist Devices 185
Table 3. Patient/Family Perspectives on Terminating MCS and Advance Care Planning
What We Know
What We Do Not Know
PC consultation and AD
38–40
PC consultation received by 68% of 19 DT patients who were offered this
service. The consultations occurred 5 days before to 16 days after implantation
For 2 of the studies,39,40 no information specific to the DT patients
A total of 85% of patients with consultation had documented ADs in chart vs
50% without consultation
We do not know whether these results are applicable to most DT patients or
those offered a different type of PC consultation
Not all patients/families understood what PC consultation was
We do not know whether patients on MCS who receive PC consultation differ
from those who do not receive it
Caregivers did not interpret candid discussion of issues negatively
Patients seriously ill when DT was discussed; thus, there was variable
engagement with PC team
After implantation, some patients only vaguely recalled advance planning
A total of 47% of MCS recipients had ADs in chart (39% for DT patients)
Most (78%) of ADs completed before implantation
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No ADs specifically mentioned MCS deactivation; general statements
about life-sustaining treatments in 63% of ADs
We did not find information about the following:
Level of satisfaction with end-of-life care
Effects of advance care planning and end-of-life care on other aspects such
as psychological well-being, decisional burden, quality of life, grief, and
bereavement of loved ones
Optimal timing for discussion(s) and best practices for end-of-life decision
making
Psychological effects of MCS deactivation on loved ones
DT patients not more or less likely than transplantation-eligible
patients to have ADs in chart
PC consulted for: symptom management (mostly pain, insomnia), clarifying
goals of therapy, advance care planning, hospice referral, and end-of-life care
After consultation: decreased opioid use, improved management of pain and
other symptoms, and increased clarity about treatment plans/goals
PC consultation well received by patients/families
A total of 30% of patients completed ADs after consultation
Termination of MCS35,41
Two patients and 12 surrogates requested deactivation: ie, 21% of 68 patients
receiving MCS in 2003–2009
Most had multi-organ failure, and on some other kind of support (eg, ventilation)
A total of 50% had ADs in chart; none mentioned MCS
For ≈80%, multidisciplinary conference held before deactivation to facilitate
decision making
A total of 85% of DT patients participating in end-of-life decisions chose to
actively turn off device (vs waiting until unconscious)
We do not know whether more patients would opt for device deactivation if
discussions were carried out while the patient was still capable of decision
making
For one of these studies,35 information specific to the DT patients was not
provided
We do not know whether these results are applicable to most DT patients
We do not know whether patients/surrogates who request termination of
MCS differ from those who do not request it
Situations motivating deactivation: infection/sepsis, renal failure, cancer, stroke
/neurological decline, impending pump failure, illegibility for pump replacement
Time from decision to deactivation: <1–14 days for active deactivation;
2–5 mo for those who waited to be unconscious
Death ≤20 min after deactivation; 55% of patients died at home
Discussions initiated by both patient/family and care providers after
quality-of-life decline
Open discussion with MCS team and supportive care at death
appreciated by family
AD indicates advance directives; DT, destination therapy; MCS, mechanical circulatory support; and PC, palliative care.
recommended.2 And perhaps one of the most important elements in clinical encounters is helping the patient recognize
that uncertainty persists in modern medicine.2 Indeed, these
considerations highlight the inherent relativity of the fully
informed concept, given the imponderables and the uniqueness of each patient with advanced heart failure.
In this perspective, we have presented what we believe is
the most comprehensive examination of the outcomes and
experiences of DT patients in the scientific literature to date.
The summaries of the themes herein presented may serve as
the basis for an information tool for care providers to use with
patients considering long-term MCS and with their informal
caregivers. Such work will likely become increasingly relevant
as waiting times for heart transplantation lengthen, availability of donor organs diminishes, and more and more patients
are offered MCS as ultimate treatment for severe heart failure.
Acknowledgments
We are grateful to Dr Lynne Stevenson for her encouragement of our
research and for her helpful comments on our article.
186 Circ Cardiovasc Qual Outcomes January 2014
Sources of Funding
This work was supported by public funds.
Disclosures
None.
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Key Words: decision support techniques ◼ heart failure ◼ heart-assist
devices
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Challenge of Informing Patient Decision Making: What Can We Tell Patients Considering
Long-Term Mechanical Circulatory Support About Outcomes, Daily Life, and End-of-Life
Issues?
Lucy J. Boothroyd, Laurie J. Lambert, Anique Ducharme, Jason R. Guertin, Georgeta Sas, Éric
Charbonneau, Michel Carrier, Renzo Cecere, Jean E. Morin and Peter Bogaty
Circ Cardiovasc Qual Outcomes. 2014;7:179-187; originally published online January 14, 2014;
doi: 10.1161/CIRCOUTCOMES.113.000243
Circulation: Cardiovascular Quality and Outcomes is published by the American Heart Association, 7272
Greenville Avenue, Dallas, TX 75231
Copyright © 2014 American Heart Association, Inc. All rights reserved.
Print ISSN: 1941-7705. Online ISSN: 1941-7713
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CIRCCQO/2013/000243R2
SUPPLEMENTAL MATERIAL
1
Supplemental Table S1. Benefits and risks: evidence base
Outcome
SURVIVAL at 1 year
at 2 years
Who this is based on
Registry: 2006-2012, 114 US centers; almost
Registry of 1694 recipients of a CF device* as DT
and 1 DT research study2 of 281 HM II recipients.
all HM II; data for 1160 DT patients
implanted in 2006-2011 in 104 US centers3:
average patient age 63.6; average BSA 2.04
m2; 11% cardiogenic shock
Same sources as above
Research patients: 2007-2009, 38 US centers;
average age 63.3; 79% male; average BSA
1.96 m2; 78% on inotropes
1
At baseline, average patient age ≈63; 79%
male (data for all 414 patients who received a
HM II in 2005-2009 in 38 US centers)
at 2 years
2 DT research studies2, 4 of 393 HM II recipients
evaluated at baseline (before implantation) and 276
evaluated at 6 months
Same sources; 153 patients evaluated at 2 years
6-MINUTE WALK
DISTANCE at 6 months
2 DT research studies2, 4 of 150 HM II recipients
evaluated at baseline and 221 evaluated at 6 months
At baseline, average patient age ≈63; 79%
male (data for all 414 patients who received a
HM II in 2005-2009 in 38 US centers)
at 2 years
Same sources; 134 patients evaluated at 2 years
ACTIVITY LEVEL at 6
months
2 DT research studies2, 4 of 365 HM II recipients
evaluated at baseline and 254 evaluated at 6 months.
(reported by Rogers et al.5)
at 2 years
Same sources; 101 patients evaluated at 2 years
END-ORGAN
FUNCTION at 6 months
1 DT research study6 of 72 patients† evaluated both
at baseline and at 6 months.
at 2 years
Same source; 33 patients† evaluated both at baseline
and at 2 years
NYHA CLASS at 1 year
At baseline, average patient age ≈63; 79%
male (data for all 414 patients who received a
HM II in 2005-2009 in 38 US centers)
Implantations in 2005-2007; 12 US centers
At baseline, average patient age 61; 73%
male; average BSA 2.0 m2; 76% on inotropes;
20% prior stroke (data for 96 HM II patients
tested at baseline)
2
QUALITY OF LIFE at 6
months
Registry1 of CF DT recipients: 852 persons evaluated
at baseline and 466 evaluated at 6 months (general
quality of life test)
2 DT research studies2, 4 of 360 HM II recipients
evaluated at baseline and 270 evaluated at 6 months
(tests specific to heart failure)
at 1 year
Same sources; 230 research study patients and 281
registry recipients evaluated at 1 year
at 2 years
Same research studies; 161 research study patients
evaluated at 2 years
INITIAL
HOSPITALIZATION
1 DT research study2 of 281 HM II recipients; 1
earlier DT research study4, 134 patients randomly
assigned to receive HM II.
At baseline, average patient age ≈63; 79%
male (data for all 414 patients who received a
HM II in 2005-2009 in 38 US centers)
HOSPITAL
READMISSIONS: time
spent in hospital
1 DT research study4 of 134 patients randomly
assigned to HM II.
At baseline, average patient age 62 (min: 26;
max: 79); 81% male; 38 US centers
7
Rate and causes of
readmissions
1 research study of 73 DT HM II patients (this
sample likely overlaps somewhat with an earlier
study of 281 HM II recipients2)
ADVERSE EVENTS:
% of recipients affected
2 DT research studies2, 4 of 414 HM II recipients who
were observed for an average support duration of
20.5 months per person. Data on respiratory failure
and hepatic dysfunction are available from one of
these studies4 (133 patients observed for an average
support duration of 19 months per person).
Registry: At baseline, average patient age ≈64
(data for all 1160 DT patients implanted in
2006-2011 in 104 US centers3)
Research patients: At baseline, average age
≈63; 79% male (data for all 414 patients who
received a HM II in 2005-2009 in 38 US
centers)
At baseline, average age ≈62; 83% male;
average initial hospital stay 16 days; 65% on
inotropes; 1 US center (data for all 115
patients discharged who received a HM II in
January 2008-June 2011; 42 of these patients
were transplant-eligible)
At baseline, average patient age ≈63; 79%
male (data for all 414 patients who received a
HM II in 2005-2009 in 38 US centers)
3
Data on timing of events from 1 research study8 of
281 HM II bridge-to-transplant recipients observed
for an average support duration of 7.8 months, and
from 169 registry patients9 who received HM II as
bridge to transplant and were observed for an average
support duration of 10.1 months
% of recipients readmitted 1 research study7 of 73 DT HM II patients who were
to hospital for each type of observed for an average support duration of 18
months per person (this sample likely overlaps
event
somewhat with an earlier study of 281 HM II
recipients2)
At baseline, average patient age 50; 76%
male; received HM II in 2005-2008 in 33 US
centers
At baseline, patients aged 40-59 years; 78%
male; received HM II in 2008 in 77 US
centers
At baseline, average age ≈62; 83% male;
average initial hospital stay 16 days; 65% on
inotropes; 1 US center (data for all 115
patients discharged who received a HM II in
2008-2011; 42 patients were transplanteligible)
CF: continuous flow; DT: destination therapy; HM II: HeartMate II®; MCS: mechanical circulatory support; US: United States of
America; BSA: body surface area; NYHA: New York Heart Association; min: minimum; max: maximum
*We assume the continuous-flow devices in INTERMACS are almost exclusively HeartMate II®.
†Sample size is the smallest number of patients tested for the various domains.
4
Supplemental Table S2. Expectations for daily life: evidence base
Outcome
LIFESTYLE
ADAPTATION
Who this is based on
Research study , 1 US hospital; recruitment in 2009-2010 7 men, 2 women; aged 31-70 years (average 56); 0.54 years of support with HM II; most Caucasian, high
Patients selected if on support for ≥ 3 months, out of
hospital; interviewed in person for 15-102 minutes in
school graduates, married, had a family caregiver
outpatient clinic; asked about experience of living with
7 were transplant-eligible; 2 men were DT patients,
MCS, lifestyle adjustments and adjustment strategies
supported for 1 and 3.5 years, aged 56 and 66
10
Research study11, 1 US hospital
Patients selected if were implanted in previous year
Patients interviewed in person for 45-90 minutes in their
homes; asked about living with MCS, how daily life had
changed and other issues considered important to them
2 men, 4 women; aged 42-76 years (average 59); 113.5 months of support (likely HM II); most were
Caucasian, married; 5 had received a heart transplant
by time of interview; 1 had chosen DT
All lived within a 3-hour drive of hospital
ADJUSTMENT
TO
CAREGIVING
Research study12, 1 US hospital
Caregivers selected if had cared for a MCS recipient at
home for ≥3 months; interviewed in person for 24-62
minutes in out-patient clinic; asked about their lifestyle
adaptations and the meaning of MCS caregiving
5 women; aged 39-71 years
Most were Caucasian, college educated, married,
give care 24 hours/day
1 caregiver of a DT patient
4 caregivers of transplant-eligible patients
SLEEP
Research study13, 1 US hospital; recruitment in 2008-2009
Patients selected if MCS candidates; no sleep disorders
Patients completed diaries/questionnaires and wore a wrist
device to measure sleep for 3 days (at home), before MCS
and up to 6 months after)
9 men, 4 women; average age 55 years
Most were Caucasian, college educated, married
3 DT patients; 8 transplant-eligible (1 received a
heart after 5 months); 2 bridge-to-decision (BTD)
All had stage D heart failure
Research study14, 1 US hospital; recruitment in 2008-2010
Patients completed standardized questionnaires before
MCS and after 6 months, at the hospital
8 men, 4 women; average age 54 years; all HM II
Almost all the same patients as above (but no heart
recipient nor BTD); most patients NYHA class IV
5
SEX AND
INTIMACY
Research study15, 1 US hospital
Patients selected if on support for ≥3 months, out of
hospital; interviewed in person for 15-102 minutes in
outpatient clinic; asked about experience of living with
MCS, and their personal, social and intimate experiences
7 men, 2 women; aged 31-70 years (average 59); 0.54 years of support with HM II; most Caucasian, high
school graduates, married, had a family caregiver
2 men were DT patients, supported for 1 and 3.5
years, aged 56 and 66 years
PSYCHOLOGICAL
DISORDERS
Research study16, 1 hospital in Germany; all MCS patients
offered psychological services
DT patients recruited in 2008-2010; all seen by a
psychologist and ICD-10 diagnoses assessed
13 men, 2 women; average age 62 years; 9-153 days
of support (average 56) with HM II for 12 patients (3
had other devices)
All DT patients
HM II: HeartMate II®; MCS: mechanical circulatory support; US: United States; DT: destination therapy; NYHA: New York Heart
Association; ICD-10: International Classification of Diseases version 10
6
Supplemental Table S3. MCS deactivation and other end-of-life issues: evidence base
Outcome
PALLIATIVE
CARE (PC)
CONSULTATION AND
ADVANCE
DIRECTIVES
(AD)
TERMINATION OF
MCS
Who this is based on
Research study , 1 US hospital
16 men, 3 women; aged 55-78 years (median
All DT patients were offered a standardized, integrated PC 70.9); all HM II and all DT patients
consultation for “advance care planning” in 2009-2010,
All patients NYHA class IIIb/IV; average duration
before implantation or shortly afterwards
of heart failure: 5.9 years
Medical charts of all DT patients were reviewed
17
Research study18, 1 US hospital
Medical charts of all MCS recipients from 2003-2009 were
reviewed (before start of PC consultation service)
56 men, 12 women; average age 59 years; mostly
Caucasian, some college education, married
33 DT and 32 transplant-eligible patients; 3
implanted as bridge-to-recovery; 78% of devices
continuous flow, otherwise pulsatile
Research study19, 1 US hospital
Medical charts of the first 20 patients who received a PC
consultation in 2009-2010 were reviewed; patients/families
asked about the impact of the PC consultation service
18 men, 2 women; aged 19-83 years (average 54)
4 DT patients
Most patients required transient inotropic support
Research study20, 1 US hospital
Medical charts of all recipients who had MCS terminated
from 2003-2009 were reviewed
13 men, 1 woman; aged 41-68 years (median 57);
length of support 1 day to 2.8 years (median 64
days); 7 DT patients (all men; 48-68 years; 2 with
CF device; 16 days to 2.8 years of support)
Utah Artificial Heart Program registry21: all DT patients
DT patients: 18 men, 2 women; aged 23-82 years
(1999-2009) actively participating in end-of-life decisions
(average 67); 2.5 months to 4.8 years of support
Primary informal caregiver interviewed in person within 2 (pulsatile devices)
weeks of patient’s death; asked what events prompted
Caregivers were mostly spouses; 2 were adult
decision to withdraw MCS; how end-of-life decision was
children; 1 was a parent
reached; if adequate assistance was provided at end of life
HM II: HeartMate II®; MCS: mechanical circulatory support; US: United States; DT: destination therapy; PC: palliative care; AD:
advance directives; CF: continuous flow
7
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