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

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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 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  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

Nurse-led, guideline based, software-supported AF-Clinic, supervised by cardiologists improves clinical outcome in patients with atrial fibrillation in comparison to usual care Hypothesis

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 CharacteristicsNurse-led Care (N = 356)Usual Care (N = 356) Age - yr66 ± 1367 ± 12 Male sex - no (%)197 (55.3)221 (62.1) Type of AF - no (%) Paroxysmal190 (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 Hypertension187 (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) Peripheral vascular disease 13 (3.7)20 (5.6) Hyperthyroidism 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 characteristics CharacteristicsNurse-led Care (N = 356)Usual Care (N = 356) CHADS2 score - no (%) 0107 (30.0) 95 (26.7) 1122 (34.3)135 (37.9) >1127 (35.7)126 (35.4) Threatment - no (%) Beta-blocker164 (46.1)187 (52.5) Digitalis 59 (16.6) 43 (12.1) Verapamil 44 (12.4) 18 (5.1) Vaughan-Williams class I & III105 (29.1) 88 (24.7) Vitamin K antagonist218 (61.2)188 (52.8) Aspirin118 (33.1)108 (30.3) Echocardiographic findings Size of left atrium, long axis - mm42 ± 643 ± 8 LV end-diastolic size - mm49 ± 6 LV end-systolic size - mm34 ± 6 LV ejection fraction - %57 ± 1056 ± 12

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 )

Results: composite endpoint

Results  Cardiovascular hospitalization - 48 patients (13.5%) Nurse-led Care - 68 patients (19.1%) Usual Care (HR 0.66, 95% CI )

Causes of cardiovascular hospitalization

Results  Cardiovascular death - 4 patients (1.1%) Nurse-led Care - 14 patients (3.9%) Usual Care (HR 0.28, 95% CI )

Causes of cardiovascular death

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