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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 1 0 (n =3 32 (n ) =6 97 2 (n ) =7 22 3 (n ) =3 71 4 (n ) =1 72 5 ) (n =7 2) 6 (n =1 5) 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