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MEDCAC Meeting

Catheter Ablation for the Treatment of Atrial Fibrillation

10/21/2009

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Issue

CMS has called this meeting for the panel to discuss the adequacy of the available evidence for the use of catheter ablative techniques to treat patients with atrial fibrillation.

Medicare does not currently have national coverage policy for the use of catheter ablation for the treatment of atrial fibrillation. In the absence of national policy, coverage of this procedure is at the discretion of local Medicare contractors (Medicare Administrative Contractors).

Atrial fibrillation is an abnormal cardiac rhythm that is triggered by aberrant electrical activity in the cardiac tissue that is near the entrance to the pulmonary veins in the left atrium. It is a common arrhythmia that increases in prevalence with age.

Strategies for the treatment of atrial fibrillation center on rate control or rhythm control. The goal of rhythm control is to restore and maintain normal sinus rhythm using drugs and/or an ablative procedure to disrupt the aberrant electrical activity. The ablative procedure can be performed using surgical methods or a less invasive catheter technique.

Actions Taken

September 1, 2009

The term "radiofrequency" has been deleted from the Issues section of this tracking sheet as the MEDCAC will review all methods of catheter ablation for the treatment of atrial fibrillation.

September 3, 2009

Posted questions to panel.

October 1, 2009

Posted Federal Register notice.

October 14, 2009

Posted agenda, roster and speaker list for meeting.

October 20, 2009

Link to AHRQ TA - Comparative Effectiveness of Radiofrequency Catheter Ablation for Atrial Fibrillation

October 26, 2009

Posted scoresheet [PDF, 164KB] from meeting.

December 9, 2009

Posted minutes [PDF, 1MB] and transcript [PDF, 428KB] from meeting.

Agenda

Federal Register Notice
Agenda
Medicare Evidence Development & Coverage Advisory Committee
October 21, 2009
7:30 AM - 4:30 PM
CMS Auditorium
Clifford Goodman, PhD, Chair
Saty Satya-Murti, MD, Vice Chair
Marcel Salive, MD, Coverage and Analysis Group
Maria Ellis, Executive Secretary

7:30 - 8:00 AM

Registration

8:00 - 8:20 AM

Opening Remarks—Maria Ellis/ Marcel Salive, MD/Clifford Goodman, PhD

8:20 - 8:35 AM

CMS Presentation & Voting Questions - JoAnna Baldwin

8:35 - 9:05 AM

Yves D. Rosenberg, MD, MPH, Acting Branch Chief, Atherothrombosis and Coronary Artery Disease Branch, Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute

9:05 - 10:00 AM

TA Presentation: Ann C. Garlitski, MD, Assistant Professor of Medicine, Co-Director, Cardiac Electrophysiology and Pacemaker Laboratory, Tufts Medical Center and Stanley Ip, MD, Center for Clinical Evidence Synthesis, Institute of Clinical Research and Health Policy Studies, Tufts Medical Center

10:00 - 10:15 AM

BREAK

10:15 - 11:00 AM

Scheduled Public Comments
(Refer to Speaker List)
Public attendees, who have contacted the executive secretary prior to the meeting, will address the panel and present information relevant to the agenda. Speakers are asked to state whether or not they have any financial involvement with manufacturers of any products being discussed or with their competitors and who funded their travel to this meeting.

11:00 - 11:30 AM

Open Public Comments

Public Attendees who wish to address the panel will be given that opportunity

11:35 - 12:35 PM

LUNCH (on your own)

12:35 - 1:35 PM

Questions to Presenters

1:35 - 2:45 PM

Initial Open Panel Discussion: Dr. Goodman

2:45 - 3:30 PM

Formal Remarks and Voting Questions

The Chairperson will ask each panel member to state his or her position on the voting questions

3:30 - 4:25 PM

Final Open Panel Discussion: Dr. Goodman

4:25 - 4:30 PM

Closing Remarks/Adjournment: Dr. Salive & Dr. Goodman

4:30 PM

ADJOURN

Minutes

Download meeting minutes [PDF, 1MB].

Panel Voting Questions

MEDCAC Panel Questions
Catheter Ablation for the Treatment of Atrial Fibrillation
October 21, 2009

Discussion Questions

Clinical Comparators
  • What is the appropriate clinical comparison for catheter ablation?
  • Does the evidence use appropriate comparison groups?
Population
  • What subpopulations of patients with atrial fibrillation should be considered for treatment of catheter ablation (paroxysmal, persistent, permanent, first-line, second-line treatment, etc.)?
  • Does the evidence address the appropriatepatient populations?
Outcomes
  • What are the outcomes of interest (ex., survival,termination of arrhythmia, hospitalization, medications [heart rate, rhythm,anticoagulants], recurrence of atrial fibrillation, adverse events, scarring)?
  • Does the available evidence assess these outcomes?
  • Have the adverse events been both qualitatively and quantitatively characterized?
  • What is the appropriate duration of follow up?
  • Does the available evidence follow patients for the appropriate period of time?
Device characteristics and physician training
  • What is the importance of the varying devices and techniques used for ablation?
  • Should the procedure be limited to physicians with specialized training (e.g, electrophysiologists, surgeons)?

Voting Questions

For each question assign a number from 1 to 5 to indicate your vote. A lower number indicates lower confidence; a higher number indicates higher confidence.

  1. How confident are you that the evidence is adequate to draw conclusions about the health outcomes of interest to patients treated with catheter ablation for atrial fibrillation?

  2. How confident are you that catheter ablation for the treatment of atrial fibrillation improves health outcomes compared to other therapies or treatments in the following populations:
    1. As first-line therapy?
    2. As second-line therapy?
    3. For first detected atrial fibrillation?
    4. For long-standing (greater than 1 year) atrial fibrillation?
    5. For paroxysmal atrial fibrillation?
    6. For persistent atrial fibrillation?

  3. How confident are you that ablation improves long-term (greater than 1 year) health outcomes?

  4. How confident are you that the outcomes can be extrapolated to:
    1. Patients outside a controlled clinical study?
    2. The Medicare beneficiary population (age 65 years and older, 56% female)?

  5. How confident are you that additional evidence is needed?

Discussion

Additional evidence, if needed
  • What type of additional evidence is needed to determine health outcomes?
  • What study designs are most appropriate to obtain this additional evidence?

Download scoresheet [PDF, 164KB]

Contact Information

Other Material

Roster

October 21, 2009
MEDCAC Roster

Clifford Goodman, PhD Chair
Senior Vice President
The Lewin Group

Saty Satya-Murti, MD,FAAN Vice Chair
Health Policy Consultant

Virginia C. Calega, MD, MBA
Vice President
Medical Management and Policy
Highmark, Inc.

Mark D. Carlson, MD, MA
Chief Medical Officer
Senior Vice President
Clinical Affairs
St. Jude Medical
Cardiac Rhythm Management Division

Gregory J. Dehmer, MD
Director, Cardiology Division
Scott & White Clinic

Mercedes K.C. Dullum, MD
Section of Cardiothoracic Surgery
Cleveland Clinic in Florida

William H. Maisel, MD, MPH
Cardiovascular Division
Beth Israel Deaconess Medical Center
Harvard Medical School

Mauro Moscucci, MD
Clinical Vice Chairman
Department of Medicine
Chief and Professor of Medicine Cardiovascular Division
University of Miami Miller School of Medicine

Craig Umscheid, MD, MSCE
University of Pennsylvania
School of Medicine

Patient Advocate

Phyllis Atkinson, RN, MS, GNP-BC
Gerotological Nurse Practitioner
Co-Owner, Advanced Geriatric Education & Consulting, LLC

Industry Representative

Neal Thomas, PhD
Senior Director
Statistical Consulting and Research Center
Pfizer Inc.

Guest Panel Members

Stephen C. Hammill, MD, FACC, FHRS
Professor of Medicine
Director
Electrocardiography Laboratory
Mayo Clinic

Douglas L. Packer, MD
Professor of Medicine
Cardiovascular Disease
Mayo Clinic

Guest Speakers

Yves D. Rosenberg, MD, MPH
Acting Branch Chief
Atherothrombosis and Coronary Artery Disease Branch
Division of Cardiovascular Sciences
National Heart, Lung and Blood Institute

CMS Liaison

Marcel Salive, MD
Director
Division of Medical & Surgical Services
Coverage and Analysis Group

Executive Secretary
Maria A. Ellis

Speaker List

Medicare Evidence Development & Coverage Advisory Committee
October 21, 2009

SPEAKER LIST

*7 MINUTES PER SPEAKER*

  • David J. Wilber, MD, Director, Cardiology and the Cardiovascular Institute, Loyola University Medical Center, for the Thermocool AF Investigators

  • Marshall Stanton, MD, Vice President, Cardiac Rhythm Disease Management, Clinical Research and Reimbursement, Medtronic

  • Matthew R. Reynolds, MD, SM, VA Boston Healthcare System, Beth Israel Deaconess Medical Center, Harvard Clinical Research Institute

  • Bradley Knight, MD, FACC, FHRS, American College of Cardiology

  • Marcia S. Yaross, PhD, Vice President, Clinical, Regulatory and Health Policy, Biosense Webster, Inc.

  • Hugh Calkins, MD, Professor of Medicine, Director of Electrophysiology, Johns Hopkins Medical Institutions, for the Heart Rhythm Society

Associated NCA

Associated Technology Assessment

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