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Catheter Ablation vs Antiarrhythmic Drug Therapy for Atrial Fibrillation: Results of the CABANA Pilot Study

Catheter Ablation vs Antiarrhythmic Drug Therapy for Atrial Fibrillation: Results of the CABANA Pilot Study.

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Catheter Ablation vs Antiarrhythmic Drug Therapy for Atrial Fibrillation: Results of the CABANA Pilot Study

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  1. Catheter Ablation vsAntiarrhythmic Drug Therapy for Atrial Fibrillation: Results of the CABANA Pilot Study Douglas L. Packer, Kerry L. Lee, Daniel B. Mark, Kristi H. Monahan,Kathleen L. Hoffmann, Gail E. Hafley, Jeanne E. Poole,Tristram D. Bahnson, David J. Bradley, Richard Robb,Maryam Rettmann, David R. Holmes III, William Stevenson,John D. Hummel, Steven J. Bailin, John D. Day, Anil K. Bhandari,Francis Marchlinski, Neil Kay, Hugh Calkins, David J. Wilber ACC Atlanta March 15, 2010

  2. Catheter Ablation vsAntiarrhythmic Drug Therapy for Atrial Fibrillation: Results of the CABANA Pilot Study Funded by St. Jude Medical Foundation,St. Paul, Minnesota Research Relationships (DLP) with Biosense, Acuson, Siemens, Cryocath, EPT, St. Jude, Cardiofocus, Symphony, Prorhythm, NIHRoyalties from IP licensed by St. Jude Medical Unpaid consulting relationships: Medtronic, Boston Scientific,St. Jude, Biosense, Siemens, Cryocath Other information available from Mayo Communications

  3. Determine the freedom from AF withablation vs drug therapy in patients withmore problematic AF and accompanyingco-morbidities Test the feasibility of a long-term pivotal trial for assessing mortality, stroke, hospitalization and cost outcomes Purpose of CABANA Pilot Study CABANA Pilot Study; ACC 2010

  4. Atrial fibrillation Warranting Therapy >65 yr of age or <65 yr with 1 CVA risk factor Eligible for ablation and/ or drug therapy R • Drug Rx and AC • Rate control • Rhythm Rx • 1° ablation & AC • PV isolation • Adjunctive Follow-up 12 months Design of the CABANA Pilot Study Inclusion Criteria • 2 paroxysmal AF episodes (1 hour) over 4 mos or >1 persistent AF episode (>1 week) • 65 yr of age, or <65 yr with 1 risk factors • Hypertension • Diabetes • Heart failure • Prior CVA or TIA • LA size >5.0 cm (Vol In 40 cc/m2) • EF 35 % • Eligible for ablation and 2 rhythm control and/or 3 rate control drugs CABANA Pilot Study; ACC 2010

  5. CABANA Pilot StudyBaseline Characteristics in 60 Patients Age (yrs) 61±10 Age <65 yrs old with 2 risk factors 25 66% Gender Male / Female (%) 77% 23% Hypertension (%) 48 80% Diabetes (%) 11 18% CAD (%) 21 35% Prior MI (%) 6 10% Prior CABG/PTCA (%) 13 22% Dilated cardiomyopathy (%) 10 17% Congestive heart failure 13 22% Ejection fraction (%) 55 ± 10 LA size (mm) 4.4±1.0 Left atrial enlargement None (%) 8 16% Mild–moderate (%) 27 54% Severe (%) 15 30% CHADS2 score 1 36 61% 2 23 39% CABANA Pilot Study; ACC 2010

  6. CABANA Pilot StudyArrhythmia History Type of AF Paroxysmal 19 32% Persistent 22 37% Long standing persistent 19 32% Years since first AF episode (yrs) 3.3±4.6 CCS AF severity Class 1-2 18 32% Class 3-4 35 61% Prior anti-arrhythmic drugs (no.) 0 42 70% 1 15 25% 2 3 5% Hospitalized for AF 28 47% Direct current cardio-version 32 53% History of atrial flutter 14 23% CABANA Pilot Study; ACC 2010

  7. 100 100 80 80 60 60 40 40 20 20 0 0 CABANA Pilot StudyTreatment Drug Therapy n=31 Ablation n=29 29 (100) n=2589% 22 71% n=1346% % % n=1138% n=6 21% 5 16% 4 13% n=1 4% Rate Rhythm Rate &rhythm PVisolation WACA/antralisolation LinearAbl CFAE GP CABANA Pilot Study; ACC 2010

  8. CABANA Pilot StudyFirst Post-Blanking AF Event Over Follow-up Drug (n=31) Ablation (n=29) n=16 52% 1st AF episode (%) n=7 24% n=4 14% n=3 10% n=3 10% n=1 3% 3-6 6-9 9-12 Months CABANA Pilot Study; ACC 2010

  9. Freedom from Recurrence of Symptomatic Atrial Fibrillation Post Blanking Period HR 0.42 (0.19-0.95) P=0.033 Ablation 65% Freedom from AFrecurrence Blankingperiod* 41% Drug Rx 24% Time (months) 1 28 27 23 20 7 2 31 30 16 13 7

  10. Freedom from Recurrence of Any Symptomatic AF, AFL, or AT HR 0.46 (0.21-0.99) P=0.042 Ablation 61% Freedom from AF/AFL/AT recurrence Blankingperiod* 23% 38% Drug Rx Months since treatment start 1 28 27 22 19 7 2 31 30 16 12 6

  11. CABANA Pilot StudyCross-Overs and Redo Therapy Ablation Rx n=29 Drug Rx n=31 n=8 28% n=6 21% n=4 13%* Pt(%) Crossoverto Abl AA Rx Re-ablation CABANA Pilot Study; ACC 2010 *2 failed Ic; 2 failed IIIs

  12. Maintenance of Sinus Rhythm in CABANA Pilot at 12 Months AAD Rx n=18 Ablation Rx n=29 n=17 n=17 n=15 +0 pt +2 pt n=13 +2 pt n=5 No AFon Rx No AFNo drug No AFLate offdrug No AFon drug Non AFwith redo CABANA Pilot Study; ACC 2010

  13. CABANA Pilot StudyRecurrence of Any AF, AFL, or AT HR 0.69 (0.37-1.32) P=0.264 Drug (72) 72% (59) 66% Blankingperiod Ablation (50) AF/AFL/AT recurrence (%) (36) Time (months) Ablation Rx 29 26 18 14 4 Drug Rx 31 30 12 8 5 CABANA Pilot Study; ACC 2010

  14. CABANA Pilot StudyPerception of Atrial Fibrillation 100 Drug (n=31) Ablation (n=29) 80 64 61 60 Patients (%) 40 29 20 13 8 4 0 Baseline 3 mo 12 mo CABANA Pilot Study; ACC 2010

  15. Adverse Events in the CABANA Pilot Study Ablation Drug Rxn=29 n=31 DVT (%) 1 (3.4) AV fistula/pseudo aneurysm (%) 2 (6.8) CVA/TIA (%) 1 (3.4) PV stenosis Moderate (50-75%) 1 (3.4) Severe (75-95%) 0 (0) Atrial esophageal fistula (%) 0 (0) Tamponade (%) 1 (3.4) Congestive heart failure (%) 3 (10.2) 1 (3.2) Volume overload (%) 2 (6.8) 0 (0) Myocardial infarction (%) 1 (3.4) 0 (0) Bradycardia (%) 1 (3.4) 0 (0) Ventricular tachycardia (%) 0 (0) 1 (3.2) Atrial flutter (%) 0 (0) 1 (3.2) LFT increase (%) 0 (0) 1 (3.2) UTI (%) 1 (3.4) 0 (0) Death, Cardiac Arrest, CVA 0 (0) 0 (0) CABANA Pilot Study; ACC 2010

  16. Limitations • Limited number of subjects in this pilot study • Follow-up was limited to 12 months • As expected a small number of patients crossed over from drug to ablative therapy • Small numbers of at risk patients at 12 months limiting “late” conclusion that can be drawn CABANA Pilot Study; ACC 2010

  17. Conclusion of the CABANA Pilot Study • Ablative intervention was more effective than drug therapy for preventing recurrent symptomatic atrial fibrillation • Treatment success rates in this population, which include a significant percentage with persistent and long-standing persistent AF, were lower than observed in other randomized clinical trials • Late recurrence of AF may reduce long-term effectiveness of ablation • This pilot study establishes the feasibility and importance of conducting a pivotal trial for establishing long-term outcome, mortality, quality of life, and cost of therapy for AF CABANA Pilot Study; ACC 2010

  18. CABANA Pilot Sites • Mayo Clinic Doug Packer • Loyola University Dave Wilber • Mercy Med/Des Moines Steve Bailin • Ohio State John Hummel • Intermountain Med Center Crandall/Day • Good Samaritan Anil Bhandari • University of Alabama Neal Kay • Mass General Boston Reddy/Ruskin • Johns Hopkins Hugh Calkins • Brigham and Womens Bill Stevenson • University of Pennsylvania Callans/Marchlinski Enrolled: 60 of 60 patients CABANA Pilot Study; ACC 2010

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