179
Background
In the management of advanced heart failure, the option of
long-term mechanical circulatory support (MCS) as destina-
tion 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 essential
1–6
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 informa-
tion. 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 fail-
ure. The current article extends the work submitted to the
Ministry
1
and focuses on MCS use in DT, within the frame-
work 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 pro-
vide a summary of currently available information and iden-
tify gaps in knowledge. Besides the use of MCS as a bridge
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 gen-
eral 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 state-
ments, 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 out-
comes 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 liv-
ing with MCS, providing care to a recipient, or terminating
MCS. For studies with mixed patient populations, informa-
tion 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.
Framework: Informed Decision Making
Informed decision making is an ethical norm and legal man-
date, which refers to the voluntary choosing of an inter-
vention (or of no intervention) by a patient, or by his/her
decision-making proxy, in light of ongoing discussion with
(Circ Cardiovasc Qual Outcomes. 2014;7:179-187.)
© 2014 American Heart Association, Inc.
Circ Cardiovasc Qual Outcomes is available at http://circoutcomes.ahajournals.org DOI: 10.1161/CIRCOUTCOMES.113.000243
Cardiovascular Perspective
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
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
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