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RATE CONTROL V/S RHYTHM CONTROL IN AF

RATE CONTROL V/S RHYTHM CONTROL IN AF. JOURNAL REVIEW RAJESH K F. Basic strategies for treatment of AF Restoration & maintenance of sinus rhythm(rhythm control) R egulation of ventricular rate during AF (rate control). Advantages of rhythm control. Physiological rhythm

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RATE CONTROL V/S RHYTHM CONTROL IN AF

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  1. RATE CONTROL V/S RHYTHM CONTROL IN AF JOURNAL REVIEW RAJESH K F

  2. Basic strategies for treatment of AF Restoration & maintenance of sinus rhythm(rhythm control) Regulation of ventricular rate during AF (rate control)

  3. Advantages of rhythm control Physiological rhythm Normal dromotropic response AV synchrony Maintained atrial contribution to ventricular filling No need for long-term anticoagulation Better hemodynamics, exercise tolerance Better prevention of complications Thrombo–embolic events Structural and electrical remodeling Better symptom relief

  4. Disadvantages Adverse effects of medication Proarrhythmia Sinus node, AV node dysfunction, pacemaker Worsening of heart failure Gastrointestinal, thyroid dyfunction More hospital admissions and higher costs Risks of interventions Electrical and chemical cardioversions Ablation, MAZE surgery Low success and high recurrence rates

  5. Determinants of long-term success in maintaining sinus rhythm Duration of AF Increased left atrial size Older age Poor left ventricular function Poor functional class CardiolClin 22 (2004) 63–69

  6. Trials comparing of rate control and rhythm control PIAF-Pharmacological Intervention in Atrial Fibrillation (2000) STAF - Strategies of Treatment of Atrial Fibrillation study(2003) RACE-Rate Control vs Electrical cardioversion for persistent AF(2002) AFFIRM-AF follow–up investigation of rhythm management (2002) HOT CAFÉ- -How to Treat Chronic Atrial Fibrillation(2004) AF CHF-Atrial Fibrillation and Congestive Heart Failure(2007) J RHYTHM- Japanese Rhythm Management Trial for AF(2009)

  7. PIAF • Rrandomized 252 patients with symptomatic and persistent AF (7 to 360 days) • Rate control (125 patients) - diltiazem and if necessary additional therapy • Rhythm control (127 patients) - amiodarone(600 mg X 3 weeks) -> electrical cardioversion • Anticoagulation (INR 2.0 to 3.0) • 1 year follow-up • Sinus rhythm in 10% of rate control vs56% of rhythm-control patients(P<.001)

  8. Primary endpoint-Improvement in symptoms related to AF • Improvement in 61% of rate vs 56% of rhythm controlled patients(P-0.317)

  9. Secondary endpoints • 6-minute walking distance -Better in rhythm controlled patients (p=0·008) • Quality of life - no differences • Incidence of hospital admissions (69% vs24%) (P-0.001) higher in rhythm-controlled • Adverse drug effects (25% vs14%) - higher in rhythm-controlled (P0.036)

  10. STAF trial Randomized 200 patients (100 /group) with persistent AF AF duration > 4 wks in 78% pts and mean duration-6 + 3 months Rate control - BBs, digitalis, CCB, or AV nodal ablation/modification with or without pacemaker Rhythm control - Repeated cardioversions and prophylactic use of class I agents or sotalol CAD or LV dysfunction -beta-blocker and/or amiodarone Oral anticoagulation in both arms of study

  11. 2 years of follow-up • Sinus rhythm -26% of rhythm Vs 11% of rate controlled patients (P-0.99) • Primary endpoint -Combination of death, stroke or TIA, TE and cardiac resuscitation • No difference - rhythm control (9/100; 5.54%/year) and rate-control (10/100; 6.09%/year; p 0.99) • 18 of 19 of events occurred during AF(p 0.049) • No significant differences in quality of life score, AF-related symptoms and echo parameters

  12. P = 0.99 P-0.99 <0.01

  13. RACE 522 patients with persistent AF or AFl(duration 1 to 399 day) Rate control (256 patients)with digoxin, CCB, and/or BB Rhythm control (266 patients) with serial cardioversions and antiarrhythmic drug Sotalol , if unsuccessfulflecainide or propafenoneamiodarone Oral anticoagulation with warfarin was used (INR 2.5 to 3.5) In cases of SR warfarin stopped /replaced by aspirin

  14. Mean follow-up of 2.3 years (plus or minus 0.6 years) • Sinus rhythm -10% of rate-controlled and 39% of rhythm-controlled patients • Primary endpoint-composite of death from CVD, HF, TE complications, bleeding, need for pacemaker,or severe adverse drug effects • No significant difference (rate-control 17.2% versus rhythm-control 22.6%)

  15. HF, TE events, adverse drug effects, and pacemaker implantations - more frequent in rhythm-control patients, Bleeding - more frequent in rate-control patients (Not statistically significant) 35 cases with TE complications - 29 occurred after cessation or during inadequate anticoagulant therapy (INR < 2.0) 17 of 21 significant bleeding occurred at an INR > 3.0

  16. AFFIRM trial Screened 7401 patients with paroxysmal or persistent AF > 65 yrs OR >1 RF for stroke or death RF – H/O HTN,DM, CHF , stroke, TIA or TE, LA >50mm or LV SF < 25% or LVEF < 0.40 4060 patients - randomized to rate or rhythm control strategies Digoxin, CCB, and/or BB were used for rate control(2027 patients) Electrical cardioversions, class IA, IC, and III drugs to rhythm-control arm (2033 ) Oral anticoagulation adjusted to maintain INR of 2.0 to 3.0 Could be stopped if SR > 4 weeks

  17. Base -line characteristics of patients

  18. Mean followup - 3.5 yrs (max 6 yrs) • At 5 yrs, sinus rhythm - 35% of rate Vs 63% of rhythm-controlled patients • Primary endpoint - Total mortality • 356/2033 (17.5%) for rhythm control and 310/2027 (15.3%) for rate control hazard ratio, 1.15 [95 % CI , 0.99 to 1.34]; P=0.08)

  19. Secondary endpoint composite (death, disabling stroke or anoxic encephalopathy, major bleeding or cardiac arrest) (No difference P-0.33) • Rhythm-controlled pts hospitalized more frequently (P < 0.001) and had more adverse drug effects (P = 0.004) • No differences in quality of-life measures between two arms

  20. HOT CAFÉ • Randomized multicenter prospective trial • 205 Patients with clinically overt persistent first episode AF • Follow up of 1.7yrs

  21. Primary endpoint –Composite of all cause mortality,TE,bleeding No difference (p 0.71) No significant difference in secondary endpoints except Incidence of hospitalization 74% vs 12% in Rhyvs rate control(p<0.001) Better exercise tolerance (p<.001) Smaller LA size in rhythm control group Better LV function in rhythm control group

  22. AF CHF • Randomized open label trial • 1376 pts EF< 35% and NYHA II–IV HF • Follow up of 3.1 years • Rhythm control-Amiodarone, in selected cases sotalol and dofetilide, electrical cardioversion • Primary endpoint –cardiovascular mortality • No difference- 182 (27%) vs 175(25%) in rhythm vs rate control(HR 1.06; 95% CI, 0.86 to 1.30; P = 0.59 by log-rank test)

  23. Secondary end points-Total mortality ,stroke,HF • Hospitalizations in first yr 46% in rhythm vs 39% in rate control group (0.0063) • On treatment analysis no survival benefit from maintenance of SR (HR 1.11;95% CI ,0.78 – 1.58; p=0.568)

  24. J RHYTHM Randomized, multicenter comparison of rate control vs rhythm control in Japanese patients with PAF 823 Patients Follow up 1.6 yrs Primary endpoint -Composite of total mortality, symptomatic cerebral infarction, systemic embolism, major bleeding, hospitalization for HF or physical/psychological disability requiring alteration of treatment strategy

  25. Primary endpoint occurred in 64 patients (15.3%) rhythm control and 89 (22.0%) to rate control (P=0.0128)

  26. Comparison of adverse outcomes in rhythm control and rate control trials in patients with AF

  27. CONCLUSION Rhythm control is not superior to rate control Rhythm-control therapies show trend toward increased mortality and morbidity caused by the adverse effects of antiarrhythmic drugs and need for cardioversions Conclusions of trials should not be generalized Patients included in trials had average age of 60 to 70 years Most had persistent AF Success rate of rhythm control was poor They could not benefit from possible advantages of sinus rhythm while being exposed to possible hazards and disadvantages of frequent cardio versions and antiarrhythmic drugs

  28. ESC 2012

  29. Catheter ablation Antiarrhythmic drugs are commonly used for prevention of recurrent AF despite inconsistent efficacy and frequent adverse effects Catheter ablation has been proposed as an alternative treatment for paroxysmal AF

  30. PAF2 Permanent AF develops in many patients after ablation and pacing therapy Multicentre randomized controlled trial 68 patients affected by severely symptomatic paroxysmal AF were assigned, after successful AV junction ablation and pacing treatment, to antiarrhythmic drug therapy with amiodarone, propafenone, flecainide or sotalol Compared with 69 patients assigned, after successful AV junction ablation and pacing treatment to no antiarrhythmic drug therapy

  31. Followed-up for 12 to 24 months (mean 16+4) Drug arm patients had 57% reduction in the risk of developing permanent AF (21% vs37%, P=0·02) Similar quality of life scores and echocardiographic parameters in the two groups Drug arm patients had more episodes of HF and hospitalizations (P=0·05) Conventional antiarrhythmic therapy reduces risk of development of permanent AF after ablation and pacing therapy

  32. RACE II Prospective, multicenter, randomized, open-label, noninferiority trial 614 patients with permanent AF Lenient rate control (resting HR <110 /min) or strict rate control strategy (resting HR <80/ min and HR during moderate exercise <110 /min) One or more negative dromotropic drugs (BBs, CCB, and digoxin) used alone or in combination and at various doses Follow-up at least 2 years, with a maximum of 3 years

  33. Primary outcome - composite of death from CV causes, hospitalization for HF & stroke, life-threatening arrhythmia & adverse effects of drugs, TE , bleeding • Primary outcome at 3 years - 12.9% in lenient and 14.9% in strict-control group (90% CI −7.6 to 3.5; P<0.001 for prespecifiednoninferiority margin)

  34. Frequencies of symptoms and adverse events similar in two groups Secondary outcomes- Components of primary outcome, death from any cause, symptoms and functional status In patients with permanent AF lenient rate control is as effective as strict rate control and is easier to achieve

  35. PHARMACOLOGICAL CARDIOVERSION IN AF

  36. ACC/AHA 2011 Pharmacological Cardioversion of Atrial Fibrillation of Up to 7-d Duration

  37. ACC/AHA 2011

  38. DOFETILIDE DIAMOND AF SAFIRE D DDAFFS EMERALD

  39. DIAMOND-AF • Substudy of 506 HF patients who had baseline AF or flutter • Pharmacological or spontaneous cardioversion occurred in 112 (44%) dofetilide and 35 (14%) placebo (P,0.001) • Probability of maintaining sinus rhythm for 1 year - 79% with dofetilide versus 42% with placebo (P,0.001) • Dofetilidehad no effect on all-cause mortality

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