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Atrial Fibrillation Rate or Rhythm Control Saeed Oraii MD Tehran Arrhythmia Clinic April 2007 Shiraz.

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Presentation on theme: "Atrial Fibrillation Rate or Rhythm Control Saeed Oraii MD Tehran Arrhythmia Clinic April 2007 Shiraz."— Presentation transcript:

1 Atrial Fibrillation Rate or Rhythm Control Saeed Oraii MD Tehran Arrhythmia Clinic April 2007 Shiraz

2 Tehran Arrhythmia Clinic First described by Sir William Harvey in 17th century: observed chaotic motion of atria in open chest animal Heart rhythm irregularity first described in 1903 by Hering ECG findings described in 1909 by Sir Thomas Lewis: “irregular or fibrillatory waves and irregular ventricular response” or “absent atrial activity with grossly irregular ventricular response” “Delirium Cordis”

3 Tehran Arrhythmia Clinic Atrial fibrillation accounts for 1/3 of all patient discharges with arrhythmia as principal diagnosis 2% VF Baily D. J Am Coll Cardiol. 1992;19(3):41A. 34% Atrial Fibrillation 18% Unspecified 6% PSVT 6% PVCs 4% Atrial Flutter 9% SSS 8% Conduction Disease 3% SCD 10% VT

4 Tehran Arrhythmia Clinic Incidence and Prevalence Prevalence increases with age –4.8 % in the age group Increases to –8.8% in the age group During the next 7-8 years, the number of people over the age of 80 is expected to quadruple

5 Tehran Arrhythmia Clinic Atrial Fibrillation Demographics by Age Adapted from Feinberg WM. Arch Intern Med. 1995;155: U.S. population Population with atrial fibrillation Age, yr < >95 U.S. population x 1000 Population with AF x ,000 20,000 10,

6 Tehran Arrhythmia Clinic Projected AF Prevalence: OLMSTED COUNTY DATA 12% observed increase in AF incidence between 1980 and 2000 Miyasaka et al, Circulation 2005; 114:119

7 Tehran Arrhythmia Clinic Adapted from Go. JAMA. 2001;285:2370. Projections of AF Prevalence in the United States Adults With AF (millions)

8 Tehran Arrhythmia Clinic Complications and Prognosis 5-fold increase in risk of stroke and thromboembolism Strokes associated with AF are more severe Death: OR 1.5 –1.9 AF worsens diagnosis in CHD and HF Impairment in cognitive function Reduced exercise tolerance

9 Tehran Arrhythmia Clinic The 10,000 Foot View … The prevalence of AF is rapidly increasing –Aging population –True increase in incidence –Lifetime risk of AF at age 40 is 25% AF is a progressive disorder –Cardiac remodeling due to genetic factors, acquired disease, atrial fibrillation itself –Up to 25% of initially self-terminating AF will become chronic in 5 years, > 50% at 10 years Associated with substantial risk of adverse outcomes beyond immediate symptoms –Stroke –Congestive heart failure –Death Associated with substantial increase in health care costs and resource utilization

10 Tehran Arrhythmia Clinic Therapeutic Approaches to Atrial Fibrillation Anticoagulation Rate Control (ventricular response) – Pharmacologic – Catheter modification/ablation of AV node Rhythm Control –Antiarrhythmic suppression –Curative procedures Catheter ablation Surgery (maze)

11 Tehran Arrhythmia Clinic Thromboembolic prophylaxis Thromboembolic events do not just occur in permanent AF Consider treatment for all patients with AF Clustering of events at the time of onset 62% RR reduction with adjusted dose Warfarin 22% RR reduction with Aspirin 0.9% absolute risk increase of major haemorrhage with Warfarin

12 Tehran Arrhythmia Clinic Risk Assessment Tools Do not apply to valvular heart disease Risk of thromboembolism depends on other risk factors in patients with AF Various risk assessment tools available There are differences between CHAD2 and the tool favoured in the NICE guidelines

13 Tehran Arrhythmia Clinic CHAD2 Score

14 Tehran Arrhythmia Clinic Therapeutic Approaches to Atrial Fibrillation Anticoagulation Rate Control – Pharmacologic – Catheter modification/ablation of AV node Rhythm Control –Antiarrhythmic suppression –Curative procedures Catheter ablation Surgery (maze)

15 Tehran Arrhythmia Clinic AF: Pharmacologic Rate Control Digitalis Beta Blockers Calcium Channel Blockers (verapamil, diltiazem) Amiodarone (in special settings)

16 Tehran Arrhythmia Clinic Atrial Fibrillation: Rate Control Essential in all patients Persistent tachycardia rates can induce cardiomyopathy and heart failure Occasional follow-up holter monitor to ascertain rate control Target: bpm rest bpm with exercise

17 Tehran Arrhythmia Clinic Adequate Rate Control AFFIRM –Average HR of ≤80 beats/min at rest and either a maximum of ≤110 bpm during a 6-minute walk or an average of <100 bpm on 24-hour Holter monitoring, with the rate not exceeding 110% of maximum predicted age-adjusted exercise rate. RACE –Resting heart rate on a 12-lead ECG of ≤100 beats/min HOT CAFÉ –A heart rate of 70–90 beats/min on a resting 12-lead ECG and ≤140 beats/min during moderate exercise

18 Tehran Arrhythmia Clinic Digoxin: some words of caution Oldest and most commonly prescribed drug for control of ventricular rate Predominant acute effect is mediated by the autonomic nervous system An important slowing effect of the AV node is mediated by enhanced vagal tone Not effective during periods of increased sympathetic tone Not effective in paroxysmal atrial fibrillation

19 Tehran Arrhythmia Clinic AVN Ablation and PPM Paroxysmal AF – DDDR pacing with mode switch Permanent AF – VVIR pacemaker Biventricular devices may be better in preserving LV function

20 Tehran Arrhythmia Clinic AVN Ablation and PPM Pros: –Controls and regularizes ventricular rate –Effective at improving symptoms, QOL and ? LV function Cons: –Permanent –Detrimental effects of RV pacing, especially if reduced LV function already –Still have thromboembolic risk –Continue to have loss of atrial contractile function

21 Tehran Arrhythmia Clinic Ablate and pace Suitable for –AF with symptomatic rapid ventricular rate unresponsive to drug Rx, or when drug Rx not tolerated –Curative AF ablation not suitable or not possible –Patients with a bradycardia indication for pacing –More suited to elderly (less requirement for generator changes and lead revision)

22 Tehran Arrhythmia Clinic Therapeutic Approaches to Atrial Fibrillation Anticoagulation Rate Control (ventricular response) – Pharmacologic – Catheter modification/ablation of AV node Rhythm Control –Antiarrhythmic suppression –Curative procedures Catheter ablation Surgery (maze)

23 Tehran Arrhythmia Clinic AF: Rhythm Control Options

24 Tehran Arrhythmia Clinic Disadvantages High recurrence rate High long-term cost Non-curative Adverse effects Potential proarrhythmia Antiarrhythmic Therapy for Atrial Fibrillation Advantages High efficacy for some patients, at least initially (< 50% of all patients) Low initial cost Noninvasive

25 Tehran Arrhythmia Clinic Proarrhythmia Drug-induced Torsade

26 Tehran Arrhythmia Clinic Rhythm vs Rate control Trials PIAF –Lancet 2000 AFFIRM –NEJM 2002 RACE –NEJM 2002 STAF –JACC 2003 Hot CAFÉ –Chest 2004

27 Tehran Arrhythmia Clinic Rate vs. Rhythm control None of the RCTs found rate control inferior in terms of mortality or quality of life. One study showed rate control reduced the mortality in patients without Heart Failure, in over 65s and in patients with CHD. Reduced rates of hospitalization and adverse events with rate control No difference in the rate of thromboembolic or hemorrhagic events Rate control is more cost effective.

28 Tehran Arrhythmia Clinic AFFIRM: Atrial Fibrillation Follow-up Investigation of Rhythm Management Design Multicenter, randomized, open, parallel group Patients 4060 patients who had atrial fibrillation that was likely to be recurrent, with other risk factors for stroke or death. Patients with contraindications for anticoagulant therapy were excluded Follow up and primary endpoint Primary endpoint: all-cause mortality. Mean 3.5 years follow up. Treatment Rate control: >1 rate-controlling drugs, plus anticoagulant, or Rhythm control: >1 antiarrhythmics, plus cardioversion as necessary; anticoagulant encouraged but could be discontinued Nonpharmacological therapies and changes in pharmacological therapy, including crossover between groups, were permitted. The AFFIRM Investigators. A comparison of rate control and rhythm control in patients with atrial fibrillation. N Engl J Med 2002;347:1825–33.

29 Tehran Arrhythmia Clinic AFFIRM Age (years) a Female (%) Predominant cardiac diagnosis (%) Coronary artery disease Cardiomyopathy Hypertension Valvular disease Other No apparent heart disease History of congestive heart failure (%) Baseline characteristics Overall (n=4060) Rate control (n=2027) Rhythm control (n=2033) AFFIRM Investigators.N Engl J Med 2002;347:1825–33. a Mean

30 Tehran Arrhythmia Clinic AFFIRM Rate control:data available Digoxin Beta-blocker Diltiazem Verapamil Rhythm control:data available Amiodarone Sotalol Drugs used in rate and rhythm control groups a No. (48.5) (46.8) (29.8) (9.6) (0.2) b (0.1) b (%) Used drug for initial therapy AFFIRM Investigators.N Engl J Med 2002;347:1825–33. Rate control No. (70.6) (68.1) (46.1) (16.8) (10.2) (4.1) (%) Used drug at any time No. (32.9) (21.8) (15.6) (4.4) (37.2) (31.2) (%) Used drug for initial therapy Rhythm control No. (54.4) (49.6) (30.0) (10.0) (62.8) (41.4) (%) Used drug at any time a A few patients in the rate and a significant number in the rhythm control groups received other antiarrhythmics b These patients immediately crossed over to the rhythm control group, a protocol violation

31 Tehran Arrhythmia Clinic AFFIRM Goals of AFFIRM –Resting HR <80 –24 hr Holter average <100 bpm. No HR above 110% of age predicted maximum –HR <110 on a six min walk Anticoagulate: -If over 48hrs of AF, must anticoag before cardioversion. -Warfarin (6-12wks), heparin, LMWH -Aspirin -If Lone AF aspirin or nothing

32 Tehran Arrhythmia Clinic AFFIRM - RESULTS - No significant difference between rate control and rhythm control groups in: —all-cause mortality (25.9 vs. 26.7%, P=0.08) —composite secondary endpoint (death, disabling stroke or anoxic encephalopathy, major bleeding, and cardiac arrest) —total number of central nervous system events (stroke or hemorrhage) Nonsignificant trends were towards reduction of all- cause mortality and CNS events with rate control, compared with rhythm control Significantly reduced hospitalization in rate control group compared with rhythm control Fewer patients initially assigned to rate control crossed over to rhythm control than crossed from rhythm to rate control (15 vs. 38% at 5 years; P<0.001)

33 Tehran Arrhythmia Clinic AFFIRM - RESULTS - Years after randomization Cumulative mortality (%) All-cause mortality AFFIRM Investigators.N Engl J Med 2002;347:1825–33. Rhythm control Rate control P=0.08

34 Tehran Arrhythmia Clinic AFFIRM - RESULTS - P Primary endpoint: all-cause mortality Secondary endpoint: death, disabling stroke, disabling encephalopathy, major bleeding, and cardiac arrest CNS event a Hospitalization <0.001 Primary and selected secondary endpoints No. (25.9) (32.7) (7.4) (73.0) (%) Rate control (n=2027) No. (26.7) (32.0) (8.9) (80.1) (%) No. (26.3) (32.3) (8.2) (76.6) (%) Overall (n=4060) Rhythm control (n=2033) AFFIRM Investigators.N Engl J Med 2002;347:1825–33. a Ischemic stroke, or primary intracerebral or subdural/subarachonoid hemorrhage

35 Tehran Arrhythmia Clinic AFFIRM - SUMMARY- In patients who had atrial fibrillation and were at high risk for stroke or death, comparison of rate and rhythm control showed: No significant difference in all-cause mortality, composite secondary endpoint (death, disabling stroke, disabling anoxic encephalopathy, major bleeding, cardiac arrest) or ischemic stroke A nonsignificant trend to reduction of all-cause mortality and stroke with rate control Reduced hospitalization with rate control Crossover to the other control method was lower in the rate control group

36 Tehran Arrhythmia Clinic RACE Trial Rate Control vs. Electrical Cardioversion 522 patients with persistent atrial fibrillation or atrial flutter (24 hours-1 year) 2 cardioversions within 1 year Rate control to HR < 100 bpm and no symptoms Rhythm control: Sotalol followed by Flecainide or Propafenone followed by Amiodarone Primary endpoint: cardiovascular death, admission or CHF, Thromboembolic events, severe bleeding, pacemaker implantation or severe anti-arrhythmic side effects

37 Tehran Arrhythmia Clinic RACE Study 522 Patients 256 patients – rate control 266 patients – cardioversion OutcomeRateRhythm Death/Stroke17.2% 22.6% Mortality 7% 6.7% CHF 3.5% 3.4% Hypertension Subgroup: Combined Endpoints: Mortality/thromboembolism/severe complication RateRhythm 19% 31%

38 Tehran Arrhythmia Clinic Rate vs. Pharmacologic Rhythm control Favor of rate control Persistent AF History of AF more than 1 year Less symptomatic > than 65 years of age History of HTN Previous AAD failure LA > 60 mm No history of CHF Patient preference Favor of rhythm control Paroxysmal AF First episode of AF More Symptomatic < than 65 years of age No history HTN No Previous AAD failure LA < 60 mm History CHF Patient preference

39 Tehran Arrhythmia Clinic Who is under-represented in AFFIRM? Young patients Paroxysmal atrial fibrillation CHF Reduced systolic function Isolated diastolic dysfunction Disabling symptoms of AF What therapies are under-represented ?  Other (newer?) drugs  Non-pharmacologic therapies

40 Tehran Arrhythmia Clinic What AFFIRM Does Not Tell Us? Optimal management for patients with moderate or severe disabling symptoms related to atrial fibrillation Outcome if better tools to maintain sinus rhythm were available Long-term implications of rate vs. rhythm control (mean duration of follow-up only 3.5 years)

41 Nonpharmacological Approaches to Atrial Fibrillation 1.Pacemaker therapy 2. Ablation 3. Surgery

42 Tehran Arrhythmia Clinic Pulmonary Vein Triggers

43 Tehran Arrhythmia Clinic Segmental Ablation

44 Tehran Arrhythmia Clinic Segmental Ablation

45 Tehran Arrhythmia Clinic Circumferential Ablation

46 Tehran Arrhythmia Clinic Circumferential Ablation

47 Tehran Arrhythmia Clinic Circumferential Ablation

48 Tehran Arrhythmia Clinic Randomized Trials of Ablation for PAF STABILE: EHJ : ; prior AAD failure; 1 episode/mo 6 mo duration; included 32% persistent AF; AAD given to ablation group; PVI+MI+CTI; blanking 1 mo; HM + 3 mo daily event montioring; endpoint 30 sec AF WANZI: JAMA 2005: 293: ); No prior AAD; 1 episode/mo 3 mo duration; PVAI; blanking 2 mo; HM + 1,3 mo event monitoring; endpoint 15 sec AF. Pilot study for RAAFT (400 pt trial) JAIS: HRS Scientific Sessions 2006; Prior AAD failure, 2 episodes/mo 6 mo duration; PVI+CTI+lines; blanking 3 mo; HM + symptom diaries; endpoint 3 min AF or palpitations PAPPONE: JACC 2006 in press, doi 10:1016. Limited prior AAD; 2 episodes /mo 6 mo duration;CPVI+CTI+lines; blanking 6 wks, daily event monitoring; endpoint 30 sec AF Major complications in 1-4% of ablation groups

49 Tehran Arrhythmia Clinic Can Ablation Improve Survival? Pappone et al JACC 2003; 42:

50 Tehran Arrhythmia Clinic Catheter ABlation Versus ANtiarhythmic Drug Therapy for Atrial Fibrillation (CABANA) Randomized trial comparing ablation to best drug therapy (rate or rhythm control) Primary endpoint: mortality (powered for 30% mortality reduction assuming 12% 3 yr mortality in drug group) Secondary endpoints: –Composite (death, disabling stroke, serious bleeding, cardiac arrest) –Freedom from AF recurrence (irrespective of symptoms) –Health care costs and resource utilization –Quality of life Planned 3000 pts, 120 enrolling centers Pilot phase approved starting late 2006, full study pending approval

51 Tehran Arrhythmia Clinic Catheter ABlation Versus ANtiarhythmic Drug Therapy for Atrial Fibrillation (CABANA) Enrollment criteria  > age 65, or 1 risk factor for stroke  Eligible for both AF, and at least 2 membrane active drugs or 3 rate control drugs  Paroxysmal (at least 2 episodes in prior 3 mo), persistent or chronic AF Ablation technique to include PVI + additional procedures (lines, CFAE, ganglionated plexi) 3 month blanking period in both groups (repeat ablation, or change in AAD permitted). Crossover to ablation in drug group strongly discouraged Follow-up with holter monitor, daily TTM (2 wks every 6 mo), and ILR (proposed 750 pt substudy)

52 Tehran Arrhythmia Clinic Potential benefits Symptomatic benefit No need for AADs ? Thromboembolic benefit ? Mortality benefit? Potential harm Death Stroke Exacerbation of arrhythmia (flutters) Tamponade / PV stenosis Failure and redo rate Curative AF ablation

53 Tehran Arrhythmia Clinic Patients with symptomatic, drug refractory atrial fibrillation, should be judged on an individual basis according to the Ablation Centre’s experience Ideally, the patient should satisfy the following criteria:  A rhythm control strategy is preferred and other therapeutic options are not as appropriate  Attempts with at least 1 AAD have failed  Preferably <70 (certainly <80!)  Preferably normal heart or mild-moderate structural heart disease (LVEF>45%?)  Preferably not a very dilated left atrium  Prepared to accept risk of stroke (based on patient factors and institution’s results)  Prepared to accept failure (based on institution’s results)  Prepared to accept need for a re-do procedure (based on institution’s results) Who Should be Offered Ablation Here and Now?

54 Tehran Arrhythmia Clinic Will need Warfarin 1 month before and minimum 3 months after procedure May require ongoing AA drug Rx AFib and LA flutter often occur in first few months after procedure. True success should be assessed after 3-6 months Permanent AFib may be considered, but ~50% success rate Points to remember:

55 Tehran Arrhythmia Clinic Summing up the evidence

56 Tehran Arrhythmia Clinic  ? Who could we offer rhythm control to?

57 Tehran Arrhythmia Clinic Key Messages All patients with AF need thromboembolic risk assessment. Rate control will benefit most of our patients but adequate rate control is necessary. Digoxin is not first line drug for rate control The plethora of antiarrhythmic drugs currently available for the treatment of AF is a reflection that none is wholly satisfactory, each having limited efficacy combined with poor safety and tolerability. Catheter ablation considered a Class 2a indication for patients with symptomatic persistent or paroxysmal AF after failure of an initial trial of AAD therapy (AHA/ACC/ESC 2006 Guidelines)

58 Tehran Arrhythmia Clinic Tehran Arrhythmia Center Tehran Arrhythmia Clinic


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