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Specialized Atrial Fibrillation Clinic
reduces cardiovascular morbidity
and mortality in patients with
atrial fibrillation
Jeroen ML Hendriks, MSc
Robert G Tieleman, PhD, MD
Department of Cardiology
Cardiovascular Research Institute
Maastricht University Medical Centre, The Netherlands
Martini Hospital Groningen, The Netherlands
Euro Heart Survey
Antithrombotics according to CHADS2 score
100
No antithrombotic drug
Other drug only
Antiplatelet
OAC + antiplatelet
OAC only
90
80
% Patients
70
60
50
40
30
20
10
5)
(n
=1
2)
6
(n
=7
72
)
5
(n
=1
71
)
4
(n
=3
22
)
3
(n
=7
97
)
2
(n
=6
32
)
0
(n
=3
1
0
Poor adherence to guidelines on management of AF
Non-adherence to guidelines increased morbidity / mortality
Nieuwlaat et al. EHJ 2005, 2006
Multivariate analysis
antithrombotic guideline deviance
Nieuwlaat et al. Am Heart J 2007
The AF-Clinic
An integrated chronic care program for
patients with atrial fibrillation
Substitution of care by specialized nurses
Management of AF according to guidelines
Dedicated knowledge software
Supervision by cardiologists
Hypothesis
Nurse-led, guideline based, software-supported
AF-Clinic, supervised by cardiologists improves
clinical outcome in patients with atrial fibrillation
in comparison to usual care
Methods
PROBE: Prospective, Randomized, Open label, Blinded
Endpoint trial, comparing the AF-Clinic to usual care
Randomization of 712 pts with newly diagnosed AF into
Nurse-led Care group or Usual Care group
Inclusion criteria
Age ≥ 18 years
AF documented on ECG
Exclusion criteria
Unsatisfactorily treated co-morbidity
(hypertension, heart failure, …)
Follow-up at least 1 year
Primary endpoint (composite)
Cardiovascular mortality
Cardiovascular hospitalization for
Heart failure
Stroke
Acute myocardial infarction
Systemic embolism
Bleeding
Arrhythmic events
Atrial Fibrillation
Syncope
Sustained ventricular tachycardia
Cardiac arrest
Life-threatening effects of drugs
Baseline characteristics
Characteristics
Nurse-led Care (N = 356)
Usual Care (N = 356)
66 ± 13
67 ± 12
197 (55.3)
221 (62.1)
190 (53.4)
203 (57.0)
Persistent
68 (19.1)
44 (12.4)
Permanent
75 (21.1)
84 (23.6)
294 (82.6)
296 (83.1)
187 (52.5)
193 (54.2)
Diabetes mellitus
50 (14.0)
46 (12.9)
Previous stroke / TIA
44 (12.4)
45 (12.6)
Coronary artery disease
33 (9.3)
38 (10.7)
Myocardial infarction
19 (5.3)
22 (6.2)
Congestive heart failure
25 (7.0)
25 (7.0)
Peripheral vascular disease
13 (3.7)
20 (5.6)
Hyperthyroidism
12 (3.4)
12 (3.4)
Mitral or aortic valve disease
12 (3.4)
21 (5.9)
6 (1.7)
7 (2.0)
Age - yr
Male sex - no (%)
Type of AF - no (%)
Paroxysmal
Symptomatic AF - no (%)
History of underlying disease
Hypertension
No underlying heart disease
Baseline characteristics
Characteristics
Nurse-led Care (N = 356)
Usual Care (N = 356)
0
107 (30.0)
95 (26.7)
1
122 (34.3)
135 (37.9)
>1
127 (35.7)
126 (35.4)
164 (46.1)
187 (52.5)
Digitalis
59 (16.6)
43 (12.1)
Verapamil
44 (12.4)
18 (5.1)
Vaughan-Williams class I & III
105 (29.1)
88 (24.7)
Vitamin K antagonist
218 (61.2)
188 (52.8)
Aspirin
118 (33.1)
108 (30.3)
Size of left atrium, long axis - mm
42 ± 6
43 ± 8
LV end-diastolic size - mm
49 ± 6
49 ± 6
LV end-systolic size - mm
34 ± 6
34 ± 6
LV ejection fraction - %
57 ± 10
56 ± 12
CHADS2 score - no (%)
Threatment - no (%)
Beta-blocker
Echocardiographic findings
Results
After a mean follow-up of 22 months
Composite end point
- 51 patients (14.3%) Nurse-led Care
- 74 patients (20.8%) Usual Care
(HR 0.65, 95% CI 0.45-0.93)
Results: composite endpoint
Results
Cardiovascular hospitalization
- 48 patients (13.5%) Nurse-led Care
- 68 patients (19.1%) Usual Care
(HR 0.66, 95% CI 0.46-0.96)
Causes of cardiovascular hospitalization
20
Heart failure
Acute myocardial
infarction
Stroke
% Endpoint
15
10
Major bleeding
Arrhythmic events
5
Life-threatening
effects of drugs
0
Nurse-led Care
Usual Care
Results
Cardiovascular death
- 4 patients (1.1%) Nurse-led Care
- 14 patients (3.9%) Usual Care
(HR 0.28, 95% CI 0.09-0.85)
Causes of cardiovascular death
4
% Endpoint
Cardiac arrhythmic
3
Cardiac non
arrhythmic
Vascular non
cardiac
2
1
0
Nurse-led Care
Usual Care
Results: guideline adherence
Echocardiogram performed
Laboratory assessment of
Thyroid Stimulating Hormone
Application of appropriate antithrombotic treatment
Appropriate prescription of
Vaughan-Williams class I or III
Avoiding rhythm control strategy
in asymptomatic patients
Avoiding rhythm control drugs in
patients with permanent AF
Results: guideline adherence
Echocardiogram performed
Laboratory assessment of
Thyroid Stimulating Hormone
Application of appropriate antithrombotic treatment
Appropriate prescription of
Vaughan-Williams class I or III
Avoiding rhythm control strategy
in asymptomatic patients
Avoiding rhythm control drugs in
patients with permanent AF
Conclusion
Management of atrial fibrillation patients
in a specialized AF-Clinic improves
outcome compared to usual care.
Members of the study group
Writing Committee
HJGM Crijns
JML Hendriks
RG Tieleman
HJM Vrijhoef
R de Wit
MH Prins
R Pisters
LAFG Pison
Y Blaauw
Steering Committee
HJGM Crijns
RG Tieleman
R de Wit
HJM Vrijhoef
Adjudication Committee
C Franke
H ten Cate
GVA van Ommen
RJMW Rennenberg
Back-up slides
Discussion
Difficult to pinpoint nurses or guidelines
or dedicated software as the sole
reason for results
Improved guideline adherence and
outcomes due to an integrated
approach: a combination of ingredients
Results: multivariate analyses