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Specialized Atrial Fibrillation Clinic reduces cardiovascular morbidity
and mortality in patients with atrial fibrillation
Jeroen ML Hendriks, MSc Jeroen ML Hendriks, MSc Robert G Tieleman, PhD, MDRobert G Tieleman, PhD, MD
Department of CardiologyDepartment of CardiologyCardiovascular Research InstituteCardiovascular Research Institute
Maastricht University Medical Centre, The NetherlandsMaastricht University Medical Centre, The NetherlandsMartini Hospital Groningen, The NetherlandsMartini Hospital Groningen, The Netherlands
Euro Heart Survey Antithrombotics according to CHADS2 score
Poor adherence to guidelines on management of AFPoor adherence to guidelines on management of AF Non-adherence to guidelines increased morbidity / mortalityNon-adherence to guidelines increased morbidity / mortality
Nieuwlaat et al. EHJ 2005, 2006
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10
20
30
40
50
60
70
80
90
100%
Pa
tie
nts
No antithrombotic drug
Other drug only
Antiplatelet
OAC + antiplatelet
OAC only
The AF-Clinic
An integrated chronic care program for patients with atrial fibrillation
Substitution of care by specialized nursesSubstitution of care by specialized nurses Management of AF according to guidelinesManagement of AF according to guidelines Dedicated knowledge softwareDedicated knowledge software Supervision by cardiologistsSupervision by cardiologists
Nurse-led, guideline based, software-Nurse-led, guideline based, software-supported AF-Clinic, supervised by supported AF-Clinic, supervised by cardiologists improves clinical outcome in cardiologists improves clinical outcome in patients with atrial fibrillation in comparison to patients with atrial fibrillation in comparison to usual careusual care
Hypothesis
Methods PROBE: Prospective, Randomized, Open label, Blinded PROBE: Prospective, Randomized, Open label, Blinded
Endpoint trial, comparing the AF-Clinic to usual careEndpoint trial, comparing the AF-Clinic to usual care
Randomization of 712 pts with newly diagnosed AF into Randomization of 712 pts with newly diagnosed AF into Nurse-led Care group or Usual Care groupNurse-led Care group or Usual Care group
Inclusion criteriaInclusion criteria Age ≥ 18 yearsAge ≥ 18 years AF documented on ECGAF documented on ECG
Exclusion criteriaExclusion criteria Unsatisfactorily treated co-morbidity (hypertension, Unsatisfactorily treated co-morbidity (hypertension,
heart failure, …)heart failure, …)
Follow-up at least 1 yearFollow-up at least 1 year
Primary endpoint (composite) Cardiovascular mortalityCardiovascular mortality
Cardiovascular hospitalization forCardiovascular hospitalization for Heart failureHeart failure StrokeStroke Acute myocardial infarctionAcute myocardial infarction Systemic embolismSystemic embolism BleedingBleeding Arrhythmic eventsArrhythmic events
Atrial FibrillationAtrial Fibrillation SyncopeSyncope Sustained ventricular tachycardiaSustained ventricular tachycardia Cardiac arrestCardiac arrest
Life-threatening effects of drugsLife-threatening effects of drugs
Baseline characteristicsCharacteristics Nurse-led Care (N = 356) Usual Care (N = 356)
Age - yr 66 ± 13 67 ± 12
Male sex - no (%) 197 (55.3) 221 (62.1)
Type of AF - no (%)
Paroxysmal 190 (53.4) 203 (57.0)
Persistent 68 (19.1) 44 (12.4)
Permanent 75 (21.1) 84 (23.6)
Symptomatic AF - no (%) 294 (82.6) 296 (83.1)
History of underlying disease
Hypertension 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)
No underlying heart disease 6 (1.7) 7 (2.0)
Baseline characteristicsCharacteristics Nurse-led Care (N = 356) Usual Care (N = 356)
CHADS2 score - no (%)
0 107 (30.0) 95 (26.7)
1 122 (34.3) 135 (37.9)
>1 127 (35.7) 126 (35.4)
Threatment - no (%)
Beta-blocker 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)
Echocardiographic findings
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
Results
After a mean follow-up of 22 monthsAfter a mean follow-up of 22 months
Composite end pointComposite end point
- 51 patients (14.3%) Nurse-led Care- 51 patients (14.3%) Nurse-led Care
- 74 patients (20.8%) Usual Care- 74 patients (20.8%) Usual Care
(HR 0.65, 95% CI 0.45-0.93)(HR 0.65, 95% CI 0.45-0.93)
Results
Cardiovascular hospitalizationCardiovascular hospitalization
- 48 patients (13.5%) Nurse-led Care- 48 patients (13.5%) Nurse-led Care
- 68 patients (19.1%) Usual Care- 68 patients (19.1%) Usual Care
(HR 0.66, 95% CI 0.46-0.96)(HR 0.66, 95% CI 0.46-0.96)
Causes of cardiovascular hospitalization
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Nurse-led Care Usual Care
% E
nd
po
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Heart failure
Acute myocardialinfarction
Stroke
Major bleeding
Arrhythmic events
Life-threateningeffects of drugs
Results
Cardiovascular deathCardiovascular death
- 4 patients (1.1%) Nurse-led Care- 4 patients (1.1%) Nurse-led Care
- 14 patients (3.9%) Usual Care- 14 patients (3.9%) Usual Care
(HR 0.28, 95% CI 0.09-0.85)(HR 0.28, 95% CI 0.09-0.85)
Causes of cardiovascular death
0
1
2
3
4
Nurse-led Care Usual Care
% E
nd
po
int
Cardiac arrhythmic
Cardiac nonarrhythmicVascular noncardiac
Results: guideline adherence
Echocardiogram performedEchocardiogram performed
Laboratory assessment of Laboratory assessment of Thyroid Stimulating HormoneThyroid Stimulating Hormone
Application of appropriate anti-Application of appropriate anti-thrombotic treatmentthrombotic treatment
Appropriate prescription of Appropriate prescription of Vaughan-Williams class I or IIIVaughan-Williams class I or III
Avoiding rhythm control strategy Avoiding rhythm control strategy in asymptomatic patientsin asymptomatic patients
Avoiding rhythm control drugs in Avoiding rhythm control drugs in patients with permanent AFpatients with permanent AF
Results: guideline adherence
Echocardiogram performed
Laboratory assessment of Thyroid Stimulating Hormone
Application of appropriate anti-thrombotic 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 Management of atrial fibrillation patients in a specializedin a specialized AF-Clinic improves AF-Clinic improves outcome compared to usual careoutcome compared to usual care..
Members of the study group
Writing CommitteeWriting CommitteeHJGM CrijnsHJGM CrijnsJML HendriksJML HendriksRG TielemanRG TielemanHJM VrijhoefHJM VrijhoefR de WitR de WitMH PrinsMH PrinsR PistersR PistersLAFG PisonLAFG PisonY BlaauwY Blaauw
Steering CommitteeSteering CommitteeHJGM CrijnsHJGM CrijnsRG TielemanRG TielemanR de WitR de WitHJM VrijhoefHJM Vrijhoef
Adjudication CommitteeAdjudication CommitteeC FrankeC FrankeH ten CateH ten CateGVA van OmmenGVA van OmmenRJMW RennenbergRJMW Rennenberg
Discussion
Difficult to pinpoint nurses or guidelines Difficult to pinpoint nurses or guidelines or dedicated software as the sole or dedicated software as the sole
reason for resultsreason for results
Improved guideline adherence and Improved guideline adherence and outcomes due to an integrated outcomes due to an integrated
approach: a combination of ingredients approach: a combination of ingredients