Download Heart Failure Management: Multidisciplinary Care has Intrinsic

Journal of Cardiac Failure Vol. 8 No. 3 2002
Heart Failure Management: Multidisciplinary
Care has Intrinsic Benefit Above the
Optimization of Medical Care
KENNETH MCDONALD, MD,1,2 MARK LEDWIDGE, PHD,1,2
JOHN CAHILL, MB,1 PETER QUIGLEY, MD,1
BRIAN MAURER, MD,1 BRONAGH TRAVERS, RN,1
MARY RYDER, RN,1 EMMA KIERAN, RN,1
LORNA TIMMONS, RN,1,2 AND ENDA RYAN, MB1
Dublin, Ireland
ABSTRACT
Purpose: This work addresses the unanswered question of whether multidisciplinary care
(MDC) of heart failure (HF) can reduce readmissions when optimal medical care is applied
in both intervention and control groups.
Methods: In a randomized, controlled study, 98 patients (mean age, 70.8 ⫾ 10.5 years)
admitted to hospital with left ventricular failure (New York Heart Association Class IV) were
assigned to routine care (RC, n ⫽ 47) or MDC (n ⫽ 51). All patients received the same
components of inpatient, optimal medical care of HF: specialist-led inpatient care; titration to
maximum tolerated dose of angiotensin-converting enzyme inhibitor before discharge;
attainment of predetermined discharge criteria (weight stable, off all intravenous therapy, and
no change in oral regimen for 2 days). Only those in the MDC group received inpatient and
outpatient education and close telephone and clinic follow-up. The primary study endpoint
was rehospitalization or death for a HF-related issue at 3 months.
Main findings: At 3 months, four people had events in the MDC group (7.8% rate over 3
months) compared with 12 people (25.5% rate over 3 months) in the RC group (P ⫽ 0.04).
Conclusion: These data demonstrate for the first time the intrinsic benefit of MDC in the
setting of protocol-driven, optimal medical management of HF. Moreover, the event rate of
7.8% at 3 months, as the lowest reported rate for such a high-risk group, underlines the value
of this approach to the management of heart failure.
Key Words: Multidisciplinary care, ACE Inhibition, readmission.
medical care.1,4-6 Beginning with the index hospitalization for heart failure (HF), published work on multidisciplinary care (MDC) has shown significant reductions in
rehospitalization rates,1,4-6 predominantly as a result of patient education, close clinical follow-up, and optimizing
outpatient medical care. However, optimal medical care
during the index hospitalization, which should comprise
specialist management, applying maximal use of proven
medical therapies and ensuring clinical stability at discharge, has not been a stated component of these studies.
It is well-recognized that diagnosis and treatment of
HF is significantly improved with specialist care.7,8
No study to date of multidisciplinary care of heart failure has shown the benefits to be independent of optimal
From the 1St Vincent’s University Hospital Heart Failure Unit and
Council on Heart Failure, Irish Heart Foundation, Dublin, Ireland
Manuscript received November 6, 2001; revised manuscript received
March 11, 2002; revised manuscript accepted April 2, 2002.
Reprint requests: Dr. Ken McDonald, St. Vincent’s University
Hospital, Elm Park, Dublin 4, Ireland.
This work is supported by unrestricted grants from the Irish Heart
Foundation and Servier Laboratories Ireland.
Copyright 2002, Elsevier Science (USA). All rights reserved.
1071-9164/02/0803-0006$35.00/0
doi:10.1054/jcaf.2002.124340
2
142
Heart Failure Management: Multidisciplinary Care has Intrinsic Benefit O McDonald
Furthermore, achievement of target dose angiotensinconverting enzyme (ACE) inhibitor has been shown to
reduce morbidity,3,9 and when applied before hospital
discharge, significantly reduces rehospitalization over 3
months.3 Finally, Ashton and colleagues have demonstrated that achieving defined clinical stability criteria
before discharge reduces readmission rates.2
Rich et al. were the first to demonstrate the benefits of
MDC in reducing HF rehospitalizations.4,5 Cline et al.
further emphasized the importance of a hospital based
HF clinic after discharge.6 Recently, Stewart and colleagues have shown the benefits of a home-based program in reducing HF rehospitalizations.1 None of these
studies counted maximization of medical therapy and
clinical stability at discharge as mandatory components
of care.1,4-6 Furthermore, as a home-based program
initiated after hospital discharge, the work by Stewart et
al. did not include predischarge specialist care of patients
with HF.1
Because all the above components of optimal medical
care will lead to reduced HF rehospitaliaation,2,3,7,8 the
question unanswered by published work to date is
whether MDC will still show benefit when these components are a standard part of the care program.
By applying optimal medical care in both intervention
and control groups, our study is the first to give a true
estimation of the intrinsic benefit of regular patient
education and support delivered as part of a MDC
program for heart failure.
Between November 1998 and April 2000, 337 patients
were admitted to St. Vincent’s University Hospital
through accident and emergency with a presumed diagnosis of HF. After review by the cardiology service, 64
patients had been incorrectly diagnosed, presenting with
asthma, exacerbation of lung disease, pneumonia, or lung
cancer (Fig. 1). A further 59 patients, although demonstrating some features of HF, were excluded because the
primary reason for hospitalization was not related to HF.
Therefore, it would be inappropriate for a HF service to
take over their management. Two hundred and fourteen
patients had a confirmed diagnosis of primary HF, 116 of
whom were excluded for reasons outlined in Table 1,
leaving a study population of 98.
In-hospital Routine Care and
Multidisciplinary Care
RC Group Patients underwent investigations for
HF, including echocardiography and right and left heart
catheterization where indicated. Optimal medical therapy
Methods
Patient Selection
The investigation conforms with the principles outlined in the Declaration of Helsinki and was approved by
the St. Vincent’s University Hospital Ethics Committee.
All patients older than 18 years of age admitted to St.
Vincent’s University Hospital through injury with a
diagnosis of HF were screened. Diagnosis of HF was
confirmed or refuted by a cardiologist based on the
presence of the following four criteria: history and
examination compatible with HF, chest X-ray appearance of congestion, echocardiography evidenced left
ventricular systolic or diastolic dysfunction, and response to initial therapy. Patients presenting with HF in
the setting of myocardial infarction or unstable angina or
in whom failure was not thought to be the primary
problem were excluded. Also not considered were those
with illnesses that could compromise survival over the
duration of the study or with cognitive impairment. After
they were stable and informed written consent was
obtained, all eligible patients were randomized to routine
care (RC) or MDC directly under the supervision of the
cardiology service.
143
Fig. 1. Details of patient screening and inclusion.
144 Journal of Cardiac Failure Vol. 8 No. 3 June 2002
was administered (see the following section). Ancillary
services such as dietary and social work consultation
were provided as requested by the attending cardiologist.
Clinical stability criteria outlined below had to be fulfilled before discharge.
MDC Group Patients underwent similar investigation
and treatment as outlined for the RC group. In addition,
patients systematically received specialist nurse-led education and specialist dietitian consults on three or more
occasions during the index admission. The education
program focused on daily weight monitoring, disease and
medication understanding, and salt restriction. Similar
advice was given to the patient’s carer or next of kin
where applicable. As in the RC group, stability criteria
had to be fulfilled before discharge.
Optimal Medical Therapy Both RC and MDC
groups underwent echocardiography to determine left
ventricular (LV) systolic function. Patients with an ejection fraction of <45% were categorized as having LV
systolic dysfunction. In this subset, diuretic and digoxin
therapy was prescribed in appropriate doses. Additionally ACE inhibitor therapy was prescribed at maximally
tolerated doses. Perindopril was selected because it may
be better tolerated on initiation and can be easily titrated
to target doses.10,11 From a starting dose of 2 mg (low
dose), patients were up-titrated to target dose of 4 mg
daily. If tolerated and deemed clinically appropriate,
higher doses (>4 mg) were used. Beta blockade was not
routinely initiated for management in view of the unproven benefit in New York Heart Association (NYHA)
Class IV HF during the course of this study. Because
there is no defined approach to the management of HF
and normal systolic function, patients with this type of
HF were managed as deemed appropriate by the attending cardiologist.
Table 1. Details of Screening and Reasons for
Patient Exclusion
Description
Patients presenting with primary
diagnosis of heart failure
Not enrolled
Nursing home
Refused consent
Cognitive impairment
Active myocardial ischemia
Died in hospital
Significant hearing/visual
impairment
Living abroad
Comorbidity compromising
survival
Immediate valve surgery
Not English-speaking
Enrolled
n
214
116
28
25
20
16
7
7
5
5
2
1
98
Stability Criteria on Discharge Clinical and therapeutic criteria for stability at discharge were predefined
and were a prerequisite for discharge in both groups.
These were:
O
O
O
O
Symptomatically improved and stable
Off all intravenous therapy for 2 days
Stable oral therapy with no dose change for 2 days
Stable dry weight (no change > 1 kg) for 2 days
Questionnaires
Patients and carers received questionnaires to assess
knowledge of HF and importance of diet at discharge and
3-month follow-up visit. In the absence of any broadly
accepted, standard patient and carer questionnaires, we
generated in-house knowledge of heart failure (20 questions) and diet (10 questions) questionnaires. These were
administered by the nurse and used primarily to assess
the success of the education component of the program
and to identify areas of weakness. They were not
pretested or validated in any way.
Outpatient Routine Care and
Multidisciplinary Care
RC Group Patients were referred back to their primary physician with a letter stating participation in the
study and that routine management of their condition can
carry on as they see fit, including review by the hospital
cardiology service, if required. Both the patient and their
physician were asked to inform the study centre if
admission to any hospital occurred before the 3-month
follow-up period. All patients were reviewed at 3 months
at the HF clinic.
MDC Group In addition to the in-hospital MDC
intervention (see previous), patients were discharged
from hospital with a letter to the referring physician
explaining the nature of the study and that management
of HF-related issues should be referred to the clinic or the
nurse. Telephone contact was made by the trained HF
nurse specialist with the patient at 3 days after discharge
and weekly thereafter until 12 weeks. The nurse making
the phone call was the same nurse who attended the
patient during the in-hospital MDC intervention, thus
providing continuity of care. During the phone call
clinical status was ascertained and any problems were
discussed. Key education issues were also discussed as
deemed necessary by the nurse. At weeks 2 and 6,
patients and their next of kin attended the HF clinic to
check clinical status and further revise key education
issues. Patients were also asked to contact the HF clinic
should they notice any clinical deterioration. This resulted in full clinical review. Advicewas given to the
patient to increase diuretic therapy by 40 mg of
frusemide or its equivalent if weight gain of2 kg or more
occurred over 1 to 3 days in the absence of clinical
Heart Failure Management: Multidisciplinary Care has Intrinsic Benefit O McDonald
deterioration. The patient was also asked to attend the HF
clinic for assessment of urea and electrolytes. Failure of
this approach to bring body weight back to baseline
resulted in full clinical review with options to use
intravenous frusemide at the clinic to regain outpatient
clinical stability.
Criteria for Admission
RC Group The decision to admit a patient was the
responsibility of the physicians in charge of care and was
not influenced by the persons involved in this study.
MDC Group The decision to readmit a patient was
made according to specific, predefined criteria. They
were: NYHA class IV, potassium <2.8 mEq/L or >6.0
meq/L, failure of the tiered medical response (augmentation of oral diuretic, clinical review and use of intravenous diuretic on one occasion) to manage clinical
deterioration, or weight gain.
Endpoints and Data Analysis
The endpoint in this study is the number of patients
with death or readmission for HF within 12 weeks. Data
were analyzed by intention to treat using Students t-test
(normal distribution) and chi-squared analysis (with
calculation of odds ratio and 95% confidence interval)
for discrete variables.
Results
Demographics
The RC and MDC groups were similar in all respects
(Table 2). It is important to emphasize that this is an
older population, more representative of community HF
is than the majority of HF trials. Furthermore, this was an
at-risk population because more than half the patients
had a known history of HF and of these 85% had
previously been admitted for this condition. Moreover,
38% of these had been admitted for HF in the 3 months
previous to this index admission.
In-hospital Course
The discharge clinical stability criteria were applied in
all cases, with the exception of one patient in the MDC
group (Table 3). This may have contributed to the length
of stay, which was similar in both groups, but longer than
the average reported in the literature. Furthermore the
majority of patients were not admitted under the cardiology service likely contributing to the increased length
hospital stay.
Of interest, 98% of patients in both groups with LV
systolic dysfunction tolerated ACE inhibitor therapy with
perindopril. All of these tolerated target or high dose
therapy before discharge, with the exception of one
Table 2. Baseline Demographic Characteristics of Total Population, Multidisciplinary Care (MDC) Group,
and Routine Care (RC) Group
Characteristic
n
Age ⫾ SD (years)
Male (n):Female (n)
Carer available—yes (n):no(n)
Systolic dysfunction—yes (n):no(n)
SBP/DBP on admission ⫾ SD (mmHg)
HR (beats/min) on admission
Sinus rhythm—yes (n):no(n)
Etiology
Ischemia—yes (n):no(n)
Hypertension—yes (n):no(n)
Valvular—yes (n):no(n)
Idiopathic—yes (n):no(n)
Previous HF—yes (n):no(n)
Previous HF admissions—yes (n):no(n)
Within 1 month—yes (n):no(n)
Within 3 months—yes (n):no(n)
Within 12 months—yes (n):no(n)
Ejection fraction ⫾ SD (%)
Total Population
98
70.80 ⫾ 10.47
145
MDC Group
RC Group
47
⫾ 70.83 ⫾ 10.69
65:33
88:10
71:27
136/77
87.9 ⫾ 19.1
52:46
51
70.76
10.37
32:19
47:4
39:12
138/79
87.0 ⫾ 17.6
24:27
46:42
9:89
18:80
8:90
53:45
45:53
5:40
12:33
24:21
37 ⫾ 13
23:28
4:47
10:41
6:45
29:22
23:28
2:21
6:17
13:10
36 ⫾ 12
23:24
5:42
8:39
2:45
24:23
22:25
3:19
6:16
11:11
38 ⫾ 15
SD, standard deviation; SBP, systolic blood pressure; DBP, diastolic blood pressure; HR, heart rate; HF, heart failure.
33:24
41:6
32:15
134/75
88.9 ⫾ 20.7
28:19
146 Journal of Cardiac Failure Vol. 8 No. 3 June 2002
Table 3. In-hospital Course of Multidisciplinary Care (MDC) group and Routine Care (RC) group
MDC Group
N
Length of stay ⫾ SD (day)
Discharge medication
EF <45%—yes(n):no(n)
ACE inhibitor prescribed—yes(n):no(n)
High dose—yes(n):no(n)
Target dose—yes(n):no(n)
Low dose—yes(n):no(n)
Mean perindopril dose ⫾ SD (mg)
Digoxin—yes(n):no(n)
Mean digoxin dose ⫾ SD (mg)
Diuretic—yes (n):no(n)
Mean frusemide dose ⫾ SD (mg)
HF specialist nurse interventions
No. of visits (in-hospital)
Time per patient, in hospital ⫾ SD (min)
Time per patient, discharge ⫾ SD (min)
HF Specialist Dietitian interventions
No. of visits (in-hospital)
Time per patient, in hospital ⫾ SD (min)
Patient knowledge of HF ⫾ SD (n/20)
Carer knowledge of HF ⫾ SD (n/10)
Patient knowledge of diet ⫾ SD (n/10)
Stability criteria on discharge, yes(n):no(n)
RC Group
P Value*
51
13.7 ⫾ 7.8
47
14.6 ⫾ 8.1
—
.58
35:16
34:1
15:20
18:17
1:34
5.5 ⫾ 1.9
25:10
0.160 ⫾ 0.072
33:2
57.1 ⫾ 28.9
27:20
26:1
15:12
11:16
0:27
6.0 ⫾ 1.9
21:6
0.173 ⫾ 0.079
26:1
75.0 ⫾ 45.4
.25
.59
.32
.40
—
.28
.57
.57
.71
.08
3.6 ⫾ 1.4
84.8 ⫾ 39.5
18.1 ⫾ 17.8
1.7 ⫾ 1
60.0 ⫾ 37.9
14.8 ⫾ 3.1
7.8 ⫾ 2.1
7.5 ⫾ 1.7
50:1
NA
NA
NA
NA
NA
11.6 ⫾ 3.1
5.8 ⫾ 1.5
6.3 ⫾ 1.6
47:0
—
—
—
—
—
<.01
<.01
<.01
—
SD, standard deviation; EF, ; ACE, angiotensin-converting enzyme; EF, ejection fraction; HF, heart failure.
*Denotes statistical analyses of MDC versus RC groups.
patient in the multidisciplinary arm. This rapid titration
of ACE inhibitor was achieved without significant
change in renal function.
On discharge, there was an indication of difference
between the two groups in terms of patient and carer
understanding of heart failure as expressed by questionnaire scores (Table 4). In addition, patient understanding
of the importance of diet and sodium restriction appeared
to be superior in the MDC group on discharge.
Endpoint and 3-Month Follow-Up
The characteristics of patients after 3 months of
follow-up are presented in Table 4 and Fig. 2.
At 3 months, more patients suffered death or readmission for HF in the RC group (25.5%) compared with the
MDC group (7.8%). There were three deaths in each
group (the population 3-month mortality is 6.1%). Two
patients in each group had an out-of-hospital sudden
death. One in each group died during hospital admission
for HF progression within the 3-month follow-up period.
Overall, rehospitalization for heart failure was far more
frequent in the RC group (25.5%) compared to the MDC
group (3.9%).
The superior knowledge regarding HF, medicines, and
diet noted in patients in the MDC group at discharge was
sustained at 3 months. No other differences in patient
characteristics and outcomes were noted.
Discussion
This study provides original, conclusive evidence of
the intrinsic benefits of multidisciplinary care in the
setting of standardized optimal medical care of HF.
Previous important contributions on the value of
multidisciplinary care have demonstrated reductions in
hospital admissions and improved quality of life with
various forms of hospital or home-based programs.1,4-6
In general, these reports have initiated their intervention
at an index hospital admission, and have focused on
patient education and close clinical follow-up.
However, standardized approaches to several aspects
of optimal inpatient medical care were not a stated part of
their protocols. These include referring all patients to a
specialty service with a specific interest in heart failure,
prescription of maximally tolerated therapy before discharge from hospital—especially with regard to ACE
inhibitors—and attainment of predefined criteria for
clinical stability before discharge. There is a wealth of
data that supports the importance of these issues with
regard to hospitalization for heart failure.2,3,7,8 Not least
of these is the observation that the bulk of early readmissions tend to occur within the first month after
discharge, suggesting lingering problems with the inpatient phase of management in current practice.1,13,14
It is our contention that the true, intrinsic value of
multidisciplinary care cannot be determined until assessed in the setting of standardized optimal medical
Heart Failure Management: Multidisciplinary Care has Intrinsic Benefit O McDonald
147
Table 4. Characteristics of the Multidisciplinary Care (MDC) group and Routine Care (RC) Group after 3 Months’ Follow-Up
Characteristic
Total
Population
MDC
Group
N
NYHA class
Ejection fraction (%)
SBP/DBP ⫾ SD (mm Hg)
98
2.29 ⫾ 0.63
38.1 ⫾ 12.6
128/74 ⫾ 23/11
51
2.21 ⫾ 0.64
38.4 ⫾ 12.9
125/73 ⫾ 22/11
HR
Potassium
Urea
Creatinine
Quality of life
Patient knowledge of HF
Carer knowledge of HF
Patient knowledge of diet
Mean ACE inhibitor dose
Mean frusemide dose
Mean digoxin dose
75.7 ⫾ 12.4
4.16 ⫾ 0.59
10.7 ⫾ 6.2
134.3 ⫾ 59.9
34.1 ⫾ 27.1
14.7 ⫾ 3.0
6.5 ⫾ 2.8
7.5 ⫾ 2.2
4.6 ⫾ 3.2
42.1 ⫾ 26.0
0.128
0.105
12
76.3 ⫾ 12.3
4.18 ⫾ 0.50
10.0 ⫾ 4.1
134.1 ⫾ 98.5
28.8 ⫾ 23.0
16.3 ⫾ 2.7
7.1 ⫾ 3.3
8.3 ⫾ 2.1
4.5 ⫾ 3.3
44.4 ⫾ 25.2
0.107
0.099
1
Readmissions for HF in 3
months
Patients with death and/or HF
readmission in 3 months
16
⫾
4
RC
Group
47
2.28 ⫾ 0.63
37.7 ⫾ 12.6
131/74 ⫾ 25/11
⫾
75.1 ⫾ 12.5
4.15 ⫾ 0.68
11.5 ⫾ 7.9
134.6 ⫾ 70.1
39.0 ⫾ 29.5
13.1 ⫾ 2.2
5.9 ⫾ 2.1
6.6 ⫾ 1.9
4.7 ⫾ 3.0
39.6 ⫾ 27.0
0.154
⫾
0.106
11
12
P*
OR,
95% CI*
—
.53
.96
.28SBP
.75DBP
.83
.79
.23
.84
.11
<.01
.24
<.01
.71
.53
.06
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
<.01
0.01-0.53
.04
0.07-0.84
NYHA, New York Heart Association; SBP, systolic blood pressure; DBP, diastolic blood pressure; SD, standard deviation; HR, heart rate; HF, heart
failure; ACE, angiotensin-converting enzyme.
*Denotes statistical analyses of MDC versus RCA groups.
care. To address this issue we focused on the three
aspects of care outlined above. Specialty care is associated with increased diagnostic accuracy of heart failure
and is also associated with improved utilization of
pharmacologic agents known to improve outcomes in
this condition.7,8 There are no data to suggest that such
specialty care has to be in a cardiology service, but
clearly should be with a group of physicians with a stated
interest in heart failure. Prescription of ACE inhibition at
maximally tolerated dose before discharge could also be
associated with reduced readmission at three months.3
The ATLAS multicenter study data points to the morbidity benefit of use of higher dose of ACE inhibitor agents
Fig. 2. Number of patients with primary endpoints (death or
readmission for heart failure) in multidisciplinary care (MDC)
and routine care (RC) groups at 3 months.
during follow-up management.9 However, ACE inhibitors are frequently underprescribed and underdosed at
time of discharge.10 The complexity of titration with
certain ACE inhibitors can also add to the difficulty in
attaining target or high dose therapy. Finally, data from
Ashton and colleagues underline the importance of
attaining specific predefined criteria for clinical stability
at discharge and thereby reducing 3-month readmission
rates.2 To our knowledge no such approach has been a
component of multidisciplinary care programs to date. In
our study these three aspects of care were standardized in
both the routine and multidisciplinary-managed groups,
thus allowing for a true assessment of the value of
multidisciplinary care.
We report an event rate of patients with death or
HF-related admission of 7.8% at 3 months after discharge in the multidisciplinary care group. This is the
lowest event rate reported to date in such a high-risk
population, characterized by hospital presentation of an
elderly patient population with acute LV failure and a
high incidence of prior hospitalization in those with a
known history of HF. With such a low event rate it is
important to note that all patients were cared for by a
specialty service, that 99% of patients attained clinical
stability at discharge, and that 97% of patients with LV
systolic dysfunction were receiving at least target dose
ACE inhibition with perindopril at discharge. The event
rate of 7.8% within 3 months was significantly lower
than that observed in the routine arm (25.5%) and was
also lower than the 38% hospitalization rate within this
148 Journal of Cardiac Failure Vol. 8 No. 3 June 2002
particular group before index admission. It is possible
that that this event rate could be further reduced with
early systematic prescription of beta blockade to those
with systolic dysfunction as indicated by the Copernicus
study.12
Certain issues regarding the design and results of this
study require further discussion. The study was designed
to address the issue of multidisciplinary care in the setting
of optimal medical care in a typical community HF population. The applicability of many studies in HF to management of the routine community patient can be questioned because of the younger age of the population
compared with the typical community profile, and the
high ratio of screened to enrolled patients. In this particular study the majority of those not randomized were already receiving 24-hour nursing care, refused consent, or
had cognitive impairment; we cannot draw conclusions
as to the potential benefit of the MDC program on these
patients. However, the mean age of the population was
more typical of the routine heart failure population, and
just under half of patients fulfilling entry criteria were
randomized making this study more generalizable than
most. Secondly, this study placed increased focus on certain aspects of inpatient medical care. We have no data to
support that the chosen components are what defines optimal medical care, but available data do underline their
importance.2,3,7,8 Unlike certain other MDC of HF programs, a major part of the MDC intervention in this program was provided during the index hospitalization.
Conclusion
In summary, this study shows conclusively that, even
in the setting of protocol-driven optimal medical care,
multidisciplinary care of severe HF provides intrinsic
and important additional benefits. Moreover, the event
rate of 7.8% at 3 months, as the lowest reported rate for
such a high-risk group, underlines the value of an
integrated in-hospital and outpatient multidisciplinary
approach to HF.
Acknowledgments
The authors gratefully acknowledge the support of the
Irish Heart Foundation and Servier Laboratories Ireland.
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