30 Seconds is the Proper Endpoint for AF Ablation YES. Hugh Calkins MD. Professor of Medicine
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1 30 Seconds is the Proper Endpoint for AF Ablation YES Hugh Calkins MD Professor of Medicine Director of Electrophysiology Johns Hopkins Medical Institutions
2 COI Disclosures Dr Calkins is a consultant to St Jude Medical, AtriCure, and Boehringer Ingelheim.
3 Professor Prash Sanders 1. World Famous Rock Star 2. Chief of EP in Adelaide 3. Charismatic with a British / John Camm like accent
4 I Have Only One Request At The End of This Debate Ask Yourself One Question Has the field of AF ablation been moved forward by the 2007 and 2012 HRS Consensus Documents, Which Established a Level Playing Field and Common Language We Can Use to Compare Outcomes of AF Ablation Techniques and Technologies?
5 Outline Case presentations HRS Consensus Document Review What has the impact of the document been? What would you suggest? Conclusion
6 Outline Case presentations HRS Consensus Document Review What has the impact of the document been? Are we better off today than we were in 2006? Be careful what you ask for.
7 Outline Case presentations HRS Consensus Document Review What has the impact of the document been? Are we better off today than we were in 2006? Be careful what you ask for.
8 Case Presentation #1 65 year old man with symptomatic paroxysmal AF undergoes AF ablation at Center X. 8 months later he is seen in follow-up. He tells his MD he feels great and has had no atrial fibrillation. He brings with him a bottle of fine wine which he gives to his EP. A 12 lead ECG is obtained and reveals atrial fibrillation. A 24 hour Holter is obtained which reveals 24 hours of continuous AF.
9 Case Presentation #1 Was this patient s AF ablation successful? A. No B. Yes C. Not sure
10 Case Presentation #1 Should the EP Give the Bottle of Wine Back to the Patient? A. Yes B. No C. Not sure
11 Case Presentation #2 65 year old man with symptomatic paroxysmal AF undergoes AF ablation at Center X. 8 months later he is seen in follow-up. He tells his MD he feels great and has had no atrial fibrillation. A 12 lead ECG is obtained and reveals atrial flutter with a controlled ventricular response. A 24 hour Holter is obtained which reveals 24 hours of continuous atrial flutter.
12 Case Presentation #2 Was this patient s AF ablation successful? A. Yes B. No C. Not sure
13 Case Presentation #3 69 year old man with symptomatic persistent AF undergoes AF ablation at Center Y. 6 months later he has recurrent AF. He is started on amiodarone and cardioverted. 4 months later he has recurrent AF and undergoes a second ablation procedure. Amiodarone is continued. 2 months later he has recurrent AF and is cardioverted. He remains on amiodarone. 5 months later he has recurrent AF and is cardioverted. A month later he is seen in follow-up and he is in sinus rhythm. He tells you he feels great.
14 Case Presentation #3 Was this patient s AF ablation successful? A. Yes B. No C. Not sure
15 Case Presentation #4 58 year old man with symptomatic paroxysmal AF undergoes AF ablation at Center Z. 8 months later he is seen in follow-up. He tells his MD he feels great and has had no atrial fibrillation. A 12 lead ECG is obtained and reveals sinus rhythm. At 12 months follow-up he remains asymptomatic. An ECG shows sinus rhythm. And a 7 day continuous Holter shows no atrial fibrillation.
16 Case Presentation #4 Was this patient s AF ablation successful? A. Yes B. No C. Not sure
17 Outline Case presentations HRS Consensus Document Review What has the impact of the document been? Are we better off today than we were in 2006? Be careful what you ask for.
18 Heart Rhythm, EuroPace, JICE March 1, 2012
19 2012 HRS/ EHRA/ ECAS EXPERT CONSENSUS STATEMENT ON CATHETER AND SURGICAL ABLATION OF ATRIAL FIBRILLATION Comprehensive state of the art review of the field of catheter and surgical ablation of atrial fibrillation Reports the findings of a Task Force convened by HRS, EHRA, and ECAS charged with defining the indications, techniques, and outcomes of these procedures This document also makes recommendations concerning research trial design and definitions for use in clinical trials and in the reporting of outcomes of AF ablation Written as a joint partnership between HRS, EHRA and ECAS Written in Collaboration with / endorsed by APHRS, AHA, ACC, STS 47 authors, 86 pages, 3 figures, 6 tables, 736 references
20 HRS/ EHRA/ ECAS EXPERT CONSENSUS STATEMENT ON CATHETER AND SURGICAL ABLATION OFATRIAL FIBRILLATION The Process Fall 2010: Initiative launched Jan and February 2011: Section writing groups prepared first drafts March and April: weekly conference calls and frequent surveys May: meeting at HRS to review second draft June, July, and August: document edited, additional surveys September: Final draft approved by writing committee Oct and November: peer review by HRS, EHRA, and ECAS November 2011: > 300 reviewer comments received, doc revised December 2011: Final Document sent out for Endorsement December 2011: Final Document endorsed by HRS, EHRA, & ECAS December 2011: Document sent to APHRS, STS, AHA, and ACC March : Date of publication on line
21 HRS/ EHRA/ ECAS EXPERT CONSENSUS STATEMENT ON CATHETER AND SURGICAL ABLATION OF ATRIAL FIBRILLATION 11 SECTIONS AF Definitions, Mechanisms, and Rationale for Ablation Indications for Catheter and Surgical Ablation of Atrial Fibrillation Techniques and endpoints for AF ablation Technologies and tools Other technical aspects; anticoag, anesthesia, esoph monitoring Follow-up considerations Outcomes and efficacy of AF ablation Complications Training requirements and competencies Surgical ablation of AF Clinical trial considerations and definitions
22 HRS/ EHRA/ ECAS EXPERT CONSENSUS STATEMENT ON CATHETER AND SURGICAL ABLATION OF ATRIAL FIBRILLATION 11 SECTIONS AF Definitions, Mechanisms, and Rationale for Ablation Indications for Catheter and Surgical Ablation of Atrial Fibrillation Techniques and endpoints for AF ablation Technologies and tools Other technical aspects; anticoag, anesthesia, esoph monitoring Follow-up considerations Outcomes and efficacy of AF ablation Complications Training requirements and competencies Surgical ablation of AF Clinical trial considerations and definitions
23 AF Definitions, Mechanisms, and Rationale for Ablation
24 Definitions and Clinical Trial Considerations
25 Definitions of Success
26 Definitions of Recurrent AF
27 Other Endpoint Definitions
28 Documentation Recommendations
29 Minimum Effectiveness Recommendations
30 Outline Case presentations HRS Consensus Document Review What has the impact of the document been? Are we better off today than we were in 2006? Be careful what you ask for.
31 What Has the Impact of the Document Been? The recommendations have been accepted worldwide and provide a common language. The FDA requires that outcomes be reported in this way. AF ablation success rates have fallen from a 90% range to the current 60-80% range. The issues of late recurrence have been uncovered and cure has vanished from our terminology. I believe we are better off today than we were in Do You?
32 Outline Case presentations HRS Consensus Document Review What has the impact of the document been? What would you suggest? Conclusion
33 What Would You Suggest? Increase 30 seconds to what? 10 minutes, 2 hours, 2 days? 1 year? Use AF burden as the endpoint. How do you plan to measure AF burden? Consider asymptomatic AF a success? Switch to a quality of life endpoint? Require hard endpoints for AF ablation like stroke and death?
34 What Would You Suggest? Increase 30 seconds to what? 10 minutes, 2 hours, 2 days? 1 year On what basis? Use AF burden as the endpoint. How do you plan to measure AF burden? Does everyone get a Linq? Consider asymptomatic AF a success? Really? Switch to a quality of life endpoint? How are you going to correct for the placebo affect? Require hard endpoints for AF ablation like stroke and death? Have you followed the state of the CABANA trial? Sometimes perfect is the enemy of good.
35 Conclusions The 30 second definition of success of AF ablation is now well established and widely accepted. I believe it is here to stay. The HRS Consensus document allows for an unlimited number of additional clinically relevant definitions of success that can be prospectively specified when a trial is launched. Our field has been advanced significantly as a result of the 30 second definition. Although it is easy to throw stones and complain about the non clinical relevant definition of success, I would ask you what would be better?
36 I Have Only One Request At The End of This Debate Ask Yourself One Question Has the field of AF ablation been moved forward by the 2007 and 2012 HRS Consensus Documents, Which Established a Level Playing Field and Common Language We Can Use to Compare AF Ablation Techniques and Technologies?
37 Thank You
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