ESC Stockholm Arrhythmias & pacing

Transcription

1 ESC Stockholm 2010 Take Home Messages for Practitioners Arrhythmias & pacing Prof. Panos E. Vardas Professor of Cardiology Heraklion University Hospital Crete, Greece

2 Disclosures Small teaching fees from G.E., St. Jude, Medtronic and Sanofi-Aventis.

3 ESC 2010 Take Home Messages for Practitioners Atrial fibrillation Sudden cardiac death ICD - CRT Pacing - Syncope

4 Thrombogenesis in AF

5 New risk stratification scheme CHADS 2 CHA 2 DS 2 -VAS C Congestive Heart Failure 1 Hypertension 1 Age > 75 years 1 Diabetes Mellitus 1 Prior Stroke or TIA 2 Age gradation and vascular disease are parts of the risk score Lip G, Halperin J, Am J Med 2010;123:484-88

6 Antithrombotic Therapy for AF ASA vs ASA+Clopidogrel Clopidogrel plus aspirin have been reported to be inferior to anticoagulation therapy for pts with AF ACTIVE W (2006) However, in a recent report of 7,554 pts, clopidogrel plus aspirin was more effective than aspirin alone for risk of major vascular events in pts with AF ACTIVE A (2009) In patients with AF for whom warfarin may be unsuitable, clopidogrel plus aspirin may be a viable alternative ACTIVE Investigators. N Engl J Med 2009;360:

7 Limitations of warfarin therapy Unpredictable response Narrow therapeutic window Routine coagulation monitoring Slow onset/offset of action Warfarin has several limitations that make it difficult to use in practice Frequent dose adjustments Numerous fooddrug interactions Numerous drugdrug interactions Warfarin resistance

8 8 Desirable advantages of a new anticoagulant As or more effective than current agents As or safer than current agents Oral Fixed dosing Minimal food and drug interactions Predictable anticoagulant response no monitoring Rapid onset and offset of action Reversible

9 9 Dabigatran An oral potent reversible direct thrombin inhibitor No interaction with food No participation with CYP450 Predictable anticoagulant effect Fixed dose No need for routine coagulation monitoring

10 Randomized Evaluation of Long-term anticoagulant therapy (RE-LY trial) Non-valvular atrial fibrillation at moderateto-high risk of stroke or systemic embolism (at least 1 high-risk factor) Warfarin 1 mg, 3mg, 5 mg (INR ) (n = 6,022) Dabigatran etexilate 110 mg BID (n = 6,076) Dabigatran etexilate 150 mg BID (n = 6,015) Primary objective: non-inferiority to warfarin Primary endpoint: stroke + systemic embolism Connolly SJ et al. N Engl J Med 2009;361:

11 RE-LY inclusion criteria Documented AF and One additional risk factor for stroke: History of previous stroke, TIA or systemic embolism LVEF less than 40% Symptomatic HF (NYHA Class II or greater) Age of 75 years or more Age of 65 years or more and one of the following additional risk factors: Diabetes mellitus, CAD or Hypertension Connolly SJ et al. N Engl J Med 2009;361:

12 Both doses of dabigatran provide: Different and complimentary advantages over warfarin 150 mg bid was associated with lower rates of stroke and systemic embolism but similar rates of major haemorrhage. 110 mg bid was associated with rates of stroke and systemic embolism similar to those of warfarin and significantly less bleedings. Connolly SJ et al. N Engl J Med 2009; 361:

13 Cummulative Incidence (%) Effect of Dronedarone on Stroke Subanalysis of ATHENA Trial 5 4 HR=0.65 P=0.021 Placebo 3 2 Stroke Dronedarone Months Placebo Dronedarone In AF patients at moderate to high risk for stroke, dronedarone reduces the risk by 35% Connolly SJ et al Circulation 2009;120:

14 Anti-Arrhythmic Therapy Catheter Ablation vs. Antiarrhythmic Drug Therapy for Atrial Fibrillation - CABANA study (ongoing) Designed to test the hypothesis that left atrial catheter ablation will be superior to current state-ofthe-art therapy with either rate control or rhythm control drugs for reducing total mortality in patients with AF. Approximately 3000 participants from 140 centers will be randomized 1:1 in an unblinded manner.

15 Anti-Arrhythmic Therapy Catheter Ablation vs. Antiarrhythmic Drug Therapy for Atrial Fibrillation - CABANA pilot study At the completion of the pilot trial, 65% of patients treated with catheter ablation were free from symptomatic AF, compared with 41% treated with antiarrhythmic drugs (58% reduction in relative risk) In terms of the recurrence of any AF, atrial flutter, or atrial tachycardia, 72% treated with drug therapy had a recurring event compared with 66% of those treated with ablation (non-significant difference) Packer D. ACC 2010

16 ESC 2010 Take Home Messages for Practitioners Atrial fibrillation Sudden cardiac death ICD CRT Pacing - Syncope

17 Timing of ICD implantation IRIS assessed the benefit of prophylactic ICD implantation early after MI (5-31 days) in a contemporary population who had undergone reperfusion therapy as well as optimal long-term medical therapy. For risk stratification were used: impaired LV function associated with an increased heart rate, as well as rapid unsustained VT. IRIS Investigators, N Engl J Med 2009;361:

18 Timing of ICD implantation Early prophylactic ICD therapy did not reduce overall mortality IRIS Investigators, N Engl J Med 2009;361:

19 CRT-D in patients with mild HF MADIT-CRT A pivotal trial that may potentially expand the use of CRT devices in HF management CRT combined with ICD decreased all-cause mortality or HF events in relatively asymptomatic patients (NYHA I &II) with an EF 30% and a QRS duration of 130ms. Moss A et al, N Engl J Med 2009; 361:

20 Leadless ICD The S-ICD System is an implantable technology that uses a subcutaneous pulse generator and subcutaneous electrode system to treat ventricular tachyarrhythmias. Additionally, no imaging equipment is required for placement of the system, since all of the components are positioned using anatomical landmarks.

21 An entirely subcutaneous ICD In small, nonrandomized studies, an entirely subcutaneous ICD consistently detected and converted VF induced during EP testing. The device also successfully detected and treated all 12 episodes of spontaneous, sustained ventricular tachyarrhythmia. Bardy G et al, N Engl J Med 2010;363:36-44

22 S-ICD System IDE clinical study A prospective, multicenter, single-arm trial approved by the FDA and designed to evaluate the safety and effectiveness of the subcutaneous implantable defibrillator (S-ICD) System. The study plans to enroll up to 330 pts at up to 35 sites globally. Primary clinical endpoints: arrhythmia conversion efficacy complication free rate at six months for patients at risk of sudden cardiac arrest.

23 Driving & ICD

24 ESC 2010 Take Home Messages for Practitioners Atrial fibrillation Sudden cardiac death ICD - CRT Pacing - Syncope

25 The PACE study Pacing to Avoid Cardiac Enlargement In patients with normal systolic function and bradycardia, conventional RV apical pacing resulted in: adverse left ventricular remodeling a reduction in the LV ejection fraction These effects were prevented by biventricular pacing. Yu et al, N Engl J Med 2009;361:

26 Syncope Class I. ILR is indicated: In an early phase of evaluation of patients with recurrent syncope of uncertain origin who have: absence of high-risk criteria that require immediate hospitalization or intensive evaluation, and a likely recurrence within battery longevity of the device (Level of evidence B) In high-risk patients in whom a comprehensive evaluation did not demonstrate a cause of syncope or lead to specific treatment (Level of evidence B)

27 Thank You