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Atrial Fibrillation: Is is time for a change of pace?

Atrial Fibrillation: Is is time for a change of pace?. Resident Grand Rounds Dr. Lee Graham Emergency Medicine R2 November 19, 2009. Disclosure. Be prepared to be Dazzled!. I just got KEYNOTE. Scenario #1. 76 year old Female Chronic paroxysmal A Fib X 6 years

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Atrial Fibrillation: Is is time for a change of pace?

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  1. Atrial Fibrillation:Is is time for a change of pace? • Resident Grand Rounds • Dr. Lee Graham • Emergency Medicine R2 • November 19, 2009

  2. Disclosure • Be prepared to be Dazzled! • I just got KEYNOTE.

  3. Scenario #1 • 76 year old Female • Chronic paroxysmal A Fib X 6 years • Meds: include Diltiazem / Coumadin • CAD / Stroke / COPD / DM / OA • Presents to ED with recurrent palpitations / presyncope • Been to Emerg 3 times in the last 3 months • HR ~135 / BP 115/76

  4. Question • “Is there a role for long-term anti-arrhythmic medications in this patient?”

  5. Scenario #2 • 52 yr old Male • Sudden onset palpitations - 6 hrs ago • Feels weak / No CP / NO dyspnea • PMed Hx - Nil • Meds - Nil • HR~140

  6. Question • “What is the evidence for chemical cardioversion for acute Atrial Fibrillation?”

  7. So why should we talk about this?

  8. Objectives. • What is the role of rhythm control in Atrial Fibrillation? Dronedarone? • Should we attempt to be getting patients back into sinus rhythm in Emerg? • If time...at the end A Fib Potpourri

  9. Atrial Fibrillation is Bad.

  10. What is Atrial Fibrillation? • Risk Factor • (causative) • Risk Marker • (bystander)

  11. Terminology • Acute - <48hrs after onset • Paroxysmal - intermittent / recurrent / self-terminating • Persistent - will not self-terminate / can cardiovert to sinus rhythm • Permanent - cannot be terminated by cardioversion or only terminates for brief intervals • Lone - <60yrs and no heart or lung disease

  12. First Detected Secondary Paroxsymal (Self-terminating) Persistent (Non self-terminating) Permanent

  13. X

  14. The great debate... • “Rate” vs “Rhythm”

  15. “Rate” vs “Rhythm” • 5 RCTS • AFFIRM • RACE • PIAF • STAF • HOT CAFE • Meta-analysis

  16. Closer look at AFFIRM • Foundation of our management of A Fib • Randomized / Multi-center • 4060 patients

  17. Inclusion • Age > 65 years old • Other risk factors for death • “likely to be recurrent” • “likely to cause illness or death” • “treatment warranted”

  18. Groups • RHYTHM • Use what you want • Could use Cardioversion • RATE • Use what you want • Goal HR 80 at rest. 110 during activity.

  19. Anti-coagulation • RATE • Continuous • RHYTHM • “Encouraged” = could be stopped • > 4 weeks • >12 weeks (preferably)

  20. Rhythm Control Drugs

  21. “almost significant trend in mortality”

  22. RATE RHYTHM 44 CNS EVENT 25 NO WARF 17 27 Bad INR 25 42 w/ Afib

  23. AFFIRM • NEJM 2002 = Intention to treat • Circulation 2006 = “In treatment” analysis

  24. Covariate Analysis Sinus rhythm 0.53 Rhythm-control 1.49

  25. AFFIRM POSITIVE “side effects” + NEGATIVE “side effects” • Rate • = • Rhythm ACTUAL control ACTUAL control POSITIVE “side effects” + NEGATIVE “side effects”

  26. AFFIRM POSITIVE “side effects” + NEGATIVE “side effects” • Rate • = • Rhythm ACTUAL control ACTUAL control POSITIVE “side effects” + “side effects” NEGATIVE

  27. Why is everyone getting so excited?

  28. First “A Fib” Drug approved in last 10 years • First drug to show effect on hard outcomes (other than atrial fibrillation recurrence)

  29. Dronedarone • SR33589 / Multaq • Noniodinated benzofuran • Electrophysiologic effects similar to AMIODARONE • Na, K, Ca currents, acteylcholine-activated potassium currents, anti-adrenergic

  30. Amiodarone Side Effects X • Iodine • Pulmonary • Hepatitis • Thyroid • Eye • MAY have fewer side effects

  31. Long lost brothers????

  32. A T H E N A

  33. rial with dronedarone to prevent ospitalization or d ath in patie ts with trial fibrillation A T H E N N A

  34. 4628 patients with ATRIAL FIBRILLATION and ADDITIONAL RF for death • Dronedarone 400mg BID vs PLACEBO

  35. Outcomes • Primary Outcome • COMPOSITE of: • cardiovascular hospitalization • + • death • Secondary Outcome • death any cause • death from CV cause • hosptilalization due to CV

  36. Inclusion • Paroxysmal or persistent A Fib or A Flutter • + one of • >70 years old • Hypertension (> 2 meds) • DM • previous stroke / TIA / embolism • Left atrial diameter > 50mm • LVEF <40% • EKGs within 6 months (one in sinus / one in afib)

  37. Inclusion Inclusion Criteria Changed During Study • Paroxysmal or persistent A Fib or A Flutter • + one of • >70 years old • Hypertension (> 2 meds) • DM • previous stroke / TIA / embolism • Left atrial diameter > 50mm • LVEF <40% • EKGs within 6 months (one in sinus / one in afib) >75 <70 excluded

  38. Exclusion • Permanent atrial fibrillation • Decompensated heart failure within 4 weeks • NYHA class IV CHF • Acute MI • Planned major surgery • HR <50 • PR 0.28 • Previous sinus-node disease not with a pacemaker • NON CARDIAC • GFR <10ml/min • K < 3.5 mmol if currently not being corrected • going to die / pregnant / breast feeding

  39. Exclusion • Permanent atrial fibrillation • Decompensated heart failure within 4 weeks • NYHA class IV CHF • Acute MI • Planned major surgery • HR <50 • PR 0.28 • Previous sinus-node disease not with a pacemaker • NON CARDIAC • GFR <10ml/min • K < 3.5 mmol if currently not being corrected • going to die / pregnant / breast feeding

  40. Patient Characteristics • Mean age 71.6 • 46.9% female • Hypertension 59.6% • LVEF < 35% (3.9%), LVEF <45% (11.9%) • Hx of NYHA II - 17.1% • III - 4.4%

  41. ATHENA • Follow-up - mean 21 +- 5 months • Study drug discontinued prematurely in: • Dronedarone - 30.2% • Placebo - 30.8% Intolerance Anti-arrhythmic drug

  42. Side Effects • Bradycardia • QT - prolongation • Gastrointestinal (26.2% vs 22.0%) P<0.001 • Nausea • Rash • Increase in serum creatinine

  43. Outcomes • Primary Outcome • COMPOSITE of: • cardiovascular hospitalization • + • death • Secondary Outcome • death any cause • death from CV cause • hosptilalization due to CV

  44. Primary Outcome • Dronedarone 31.9% • Placebo 39.4% Death 2.6% Hospitalization 29.3% Death 2.5% Hospitalization 36.9% Hazard ratio 0.76 (0.69 - 0.84)

  45. Secondary Outcomes • death any cause • Dronedarone 5.0% • Placebo 6.0% • death from CV cause • Dronedarone 2.7% • Placebo 3.9% • first hosptilalization due to CV • Dronedarone 29.3% • Placebo 36.9% HR 0.84 (0.66 - 1.08) HR 0.71 (0.51 - 0.98) HR 0.74 (0.67 - 0.82)

  46. First Hospitalization

  47. Contribution of A Fib Hospitalization • CV Hospitalization = 7.6 • Primary Outcome = 7.5 = 7.3

  48. Limitations • High rate of discontinuing study drug • No comparison to other anti-arrhythmic • Importance of primary outcome?

  49. A N D R O M E A D

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