Specialized Atrial Fibrillation Clinic reduces cardiovascular morbidity and mortality in patients with atrial fibrillation Jeroen ML Hendriks, MSc Robert.

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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No antithrombotic drug

Other drug only

Antiplatelet

OAC + antiplatelet

OAC only

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 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: composite endpoint

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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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

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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

Back-up slides

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

Results: multivariate analyses