Management of Carotid Atherosclerosis

CMS evidence review | evidence_type=MEDCAC Meeting | record_type=medcac_meeting | document_id=62 | meeting_date=2012-01-25

The Centers for Medicare & Medicaid Services (CMS) has convened this meeting for the panel to review available evidence on various clinical strategies for the management of carotid atherosclerosis. Carotid artery atherosclerosis can increase the risk of disabling or fatal stroke. Stroke, according to the Centers for Disease Control (CDC), is the third leading cause of death and the leading cause of serious long-term disability in the United States. Treatments and technologies used in the management of carotid atherosclerosis include medical therapy, carotid endarterectomy (CEA) and carotid artery stenting (CAS). Medical therapy may involve utilization of anti-platelet drugs, statins, antihypertensives, risk factor modification (smoking cessation and diabetic control), plus lifestyle modification (exercise). CEA is an open surgical procedure in which fatty deposits or plaques are excised from the atherosclerotic segment of the carotid artery. CAS is a catheter-based procedure in which a stent is placed within the atherosclerotic carotid artery. CAS strategies include use of an embolic protection device helps to minimize debris that may dislodge during the procedure. The meeting will focus on the impact on patient health outcomes of these strategies for management of carotid atherosclerosis and prevention of stroke in both symptomatic and asymptomatic patients, as well as evaluating generalizability of the available evidence to patients of different age, gender, and racial/ethnic backgrounds. Medicare addresses coverage of CAS in section 20.7 of the national coverage determination (NCD) manual (Pub. 100-03) entitled Percutaneous Transluminal Angioplasty (PTA). Sections B2, B3 and B4 of this NCD address coverage of CAS. The NCD is available at http://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=201&ncdver=9 .

Actions Taken: November 18, 2011 Posted Federal Register Notice announcing meeting. November 22, 2011 Posted questions to panel. January 20, 2012 Posted agenda , roster and speakers list . Also posted presentations for meeting [ZIP, 13MB]. January 26, 2012 Posted scoresheet [PDF, 69KB] from meeting. January 31, 2012 Posted written comments [PDF, 2MB] from meeting. May 10, 2012 Posted minutes [PDF, 116KB] and transcript [PDF, 485KB] from meeting. Agenda: Federal Register Notice Agenda Medicare Evidence Development & Coverage Advisory Committee January 25, 2012 7:30 AM - 4:30 PM CMS Auditorium Clifford Goodman, PhD, Chair Steve Phurrough, MD, Vice Chair Louis Jacques, MD, Director, Coverage and Analysis Group Maria Ellis , Executive Secretary 7:30 - 8:00 AM Registration 8:00 - 8:15 AM Opening Remarks— Maria Ellis/Patrick Conway, MD/Louis Jacques, MD/Clifford Goodman, PhD 8:15 - 8:25 AM CMS Presentation & Voting Questions - Sarah McClain Fulton, MHS 8:25 - 9:10 AM TA Presentation: Mark Grant, MD, MPH, Associate Director, Technology Evaluation Center, Blue Cross Blue Shield Association 9:10 - 9:30 AM William A. Gray, MD , Director, Endovascular Services, Columbia University Medical Center, New York-Presbyterian Hospital, Assistant Professor, Clinical Medicine, Columbia University College of Physicians and Surgeons 9:30 - 9:50 AM Wesley Moore, MD , Professor and Chief Emeritus, Division of Vascular Surgery, David Geffen School of Medicine at UCLA, Gonda (Goldschmied) Vascular Center 9:50 - 10:10 AM Anne L. Abbott, MD, PhD, Senior Research Fellow, Baker IDI Heart and Diabetes Institute, Victoria Australia 10:10 - 10:25 AM Thomas G. Brott, MD, Professor of Neurology, Dean for Research, Mayo Clinic 10:25 - 10:30 AM BREAK 10:30 - 11:20 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. 11:20 - 11:30 AM Open Public Comments Public Attendees who wish to address the panel will be given that opportunity p 11:30 - 12:00 PM Questions to Presenters 12:00 - 1:00 PM LUNCH (on your own) 1:00 - 2:00 PM Initial Open Panel Discussion: Dr. Goodman 2:00 - 3:00 PM Formal Remarks and Voting Questions The Chairperson will ask each panel member to state his or her position on the voting questionsp 3:00 - 4:00 PM Final Open Panel Discussion: Dr. Goodman 4:00 - 4:30 PM Closing Remarks/Adjournment: Dr. Jacques & Dr. Goodman Download PDF [PDF, 16KB] of agenda. Issue: The Centers for Medicare & Medicaid Services (CMS) has convened this meeting for the panel to review available evidence on various clinical strategies for the management of carotid atherosclerosis. Carotid artery atherosclerosis can increase the risk of disabling or fatal stroke. Stroke, according to the Centers for Disease Control (CDC), is the third leading cause of death and the leading cause of serious long-term disability in the United States. Treatments and technologies used in the management of carotid atherosclerosis include medical therapy, carotid endarterectomy (CEA) and carotid artery stenting (CAS). Medical therapy may involve utilization of anti-platelet drugs, statins, antihypertensives, risk factor modification (smoking cessation and diabetic control), plus lifestyle modification (exercise). CEA is an open surgical procedure in which fatty deposits or plaques are excised from the atherosclerotic segment of the carotid artery. CAS is a catheter-based procedure in which a stent is placed within the atherosclerotic carotid artery. CAS strategies include use of an embolic protection device helps to minimize debris that may dislodge during the procedure. The meeting will focus on the impact on patient health outcomes of these strategies for management of carotid atherosclerosis and prevention of stroke in both symptomatic and asymptomatic patients, as well as evaluating generalizability of the available evidence to patients of different age, gender, and racial/ethnic backgrounds. Medicare addresses coverage of CAS in section 20.7 of the national coverage determination (NCD) manual (Pub. 100-03) entitled Percutaneous Transluminal Angioplasty (PTA). Sections B2, B3 and B4 of this NCD address coverage of CAS. The NCD is available at http://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=201&ncdver=9 . Minutes: Download meeting minutes [PDF, 116KB] Other Material: Transcript 1 Presentations [ZIP, 14MB] Written comments [PDF, 2MB] Panel Voting Questions: January 25, 2012 MEDCAC Management of Carotid Atherosclerosis Questions The primary focus of this MEDCAC meeting is on whether or not carotid artery stenting (CAS), carotid endarterectomy (CEA) and best medical therapy (BMT) improve outcomes in symptomatic and asymptomatic persons with carotid atherosclerosis. In discussing the management of such individuals, CMS is most interested in stroke prevention; and the health outcomes of interest are stroke (all stroke) and death (all cause mortality). Symptomatic means: (1) the presence or absence of focal signs or symptoms of a transient ischemic attack (reversible and lasting < 24 hours), (2) amaurosis fugax (sudden loss of vision in one eye) or (3) an ischemic stroke in either cerebral hemisphere. Asymptomatic means the absence of all of these events. We also seek the panel’s input on whether or not the published evidence for these strategies is generalizable to the Medicare population – for both men and women, as well as persons of different racial/ethnic backgrounds. Voting Questions Please use the following scale identifying your level of confidence - with a score of 1 being low or no confidence, and 5 representing high confidence. 1 — 2 — 3 — 4 — 5 Low Intermediate High Confidence Confidence Confidence How confident are you that there is adequate evidence to determine if persons in the Medicare population who are asymptomatic for carotid atherosclerosis can be identified as being at high risk for stroke in either cerebral hemisphere? 1 — 2 — 3 — 4 — 5 Low Intermediate High Confidence Confidence Confidence Discussion: If there is at least intermediate confidence (score ≥ 2.5 above), are there ethical concerns to conducting randomized controlled trials of CAS/CEA/BMT in the general asymptomatic population? Would such trials only be appropriate for those identified to be at high risk for stroke? How confident are you that there is adequate evidence to determine if persons in the Medicare population, who are considering carotid revascularization, can be identified as being at high risk for adverse events from CEA? 1 — 2 — 3 — 4 — 5 Low Intermediate High Confidence Confidence Confidence Discussion: If there is at least intermediate confidence (score ≥ 2.5 above), how does one reliably (across medical and surgical specialties) identify these individuals? For persons with symptomatic carotid atherosclerosis and carotid narrowing ( ≥ 50% by angiography or ≥ 70% by ultrasound) who are not generally considered at high risk for adverse events from CEA: How confident are you that there is adequate evidence to determine whether or not either CAS or CEA is the favored treatment strategy, as compared to BMT alone, to decrease stroke or death in the Medicare population? If there is at least intermediate confidence (score ≥ 2.5 above), how confident are you that CAS is the favored treatment strategy in this population? CEA is the favored treatment strategy in this population? BMT alone is the favored treatment strategy in this population? 1 — 2 — 3 — 4 — 5 Low Intermediate High Confidence Confidence Confidence Discussion: If there is at least intermediate confidence (score ≥ 2.5 above) for questions 3.b.i, ii or iii above, please discuss the impact of the following on your conclusions: Patient age, gender, and racial/ethnic background Time to treatment, e.g., < 2 weeks or > 2 weeks from onset of symptoms For persons with asymptomatic carotid atherosclerosis and carotid narrowing ( ≥ 60% by angiography or ≥ 70% by ultrasound) who are not generally considered at high risk for adverse events from CEA: How confident are you that there is adequate evidence to determine whether or not either CAS or CEA is the favored treatment strategy, as compared to BMT alone, to decrease stroke or death in the Medicare population? If there is at least intermediate confidence (score ≥ 2.5 above), how confident are you that CAS is the favored treatment strategy in this population? CEA is the favored treatment strategy in this population? BMT alone is the favored treatment strategy in this population? 1 — 2 — 3 — 4 — 5 Low Intermediate High Confidence Confidence Confidence Discussion: If the there is at least intermediate confidence (score ≥ 2.5 above), please discuss the impact of the following on your conclusions: Patient age, gender, and racial/ethnic background (for questions 4.b.i,ii or iii) Concurrent BMT (for questions 4.b.i or ii) For persons with asymptomatic carotid atherosclerosis who are not generally considered at high risk for stroke in either cerebral hemisphere: How confident are you that there is adequate evidence to determine whether or not CAS or CEA or BMT alone is the favored treatment strategy to decrease stroke or death in the Medicare population? If there is at least intermediate confidence (score ≥ 2.5 above), how confident are you that CAS is the favored treatment strategy in this population? CEA is the favored treatment strategy in this population? BMT alone is the favored treatment strategy in this population? 1 — 2 — 3 — 4 — 5 Low Intermediate High Confidence Confidence Confidence Discussion: If the there is at least intermediate confidence (score ≥ 2.5 above), please discuss the impact of the following on your conclusions: Patient age, gender, and racial/ethnic background (for questions 5.b.i,ii or iii) Concurrent BMT (for questions 5.b.i or ii) In the general Medicare population: How confident are you that there is adequate evidence to determine whether or not carotid artery screening of asymptomatic persons decreases stroke or death? If there is at least intermediate confidence (score ≥ 2.5 above), how confident are you that carotid artery screening of asymptomatic persons decreases stroke or death? 1 — 2 — 3 — 4 — 5 Low Intermediate High Confidence Confidence Confidence Additional Discussion Question What unmet research needs, specific to the following issues, are important to consider and explore further? Should future stroke prevention trials Be powered to evaluate only symptomatic or asymptomatic patients? Be powered to draw conclusions regarding gender? Evaluate outcomes for more racially/ethnically diverse patient populations? So as to help delineate those who require carotid revascularization from those who do not, how should future trials best utilize and validate for the Medicare population the following tools to identify persons with asymptomatic carotid atherosclerosis who are at high risk for stroke? Advanced imaging, such as 3D ultrasound, for plaque morphology Transcranial Doppler (TCD) for cerebral microembolization Pre- and post-procedure diffusion weighted MRI (DW-MRI) for silent infarcts Risk assessment tools and predictive stroke models Download Scoresheet [PDF, 69KB] Roster: MEDCAC Roster January 25, 2012 Clifford Goodman, PhD CHAIR Senior Vice President The Lewin Group Steve E. Phurrough, MD Vice Chair Chief Operating Officer/Senior Clincal Director Center for Medical Technology Policy Jeptha P. Curtis, MD Assistant Professor Department of Internal Medicine Yale University School of Medicine Philip B. Gorelick, MD, MPH John S. Garvin, Professor & Head Department of Neurology and Rehabilitation University of Illinois at Chicago College of Medicine Mark A. Hlatky, MD Professor Health Research and Policy and Cardiovascular Medicine Stanford University School of Medicine Pearl Moore, RN, MN, FAAN Adjunct Assistant Professor University of Pittsburgh School of Nursing William R. Phillips, MD, MPH Clinical Professor Family Medicine and Health Services University of Washington Art Sedrakyan, MD, PhD Associate Professor Director Patient Centered Comparative Outcomes Research Program Weill Cornell Medical School Robert L. Steinbrook, MD Adjunct Associate Professor of Medicine and Community and Family Medicine Dartmouth Medical School Robert K. Zeman, MD Professor and Chairman of Radiology George Washington University School of Medicine Diagnostic Radiology Residency Program Director Radiologist-in-chief (Radiology and Radiation Oncology) George Washington University Medical Faculty Associates, Inc., and Hospital Industry Representative Peter Juhn, MD, MPH President Therapeutic Resource Centers Medco Health Solutions, Inc. Guest Panel Members Larry B. Goldstein, MD, FAAN, FAHA Professor of Medicine (Neurology) Director, Duke Stroke Center A. Mark Fendrick, MD Professor Division of General Medicine Department of Internal Medicine and Department of Health Management and Policy Co-Director University of Michigan Center for Value-Based Insurance Design Director Health Services Research Core Lab J. David Spence, BA, MBA, MD, FRCPC, FAHA Professor of Neurology and Clinical Pharmacology University of Western Ontario Director, Stroke Prevention & Atherosclerosis Research Centre Robarts Research Institute Invited Guest Speakers Anne L. Abbott, MD, PhD Senior Research Fellow Baker IDI Heart and Diabetes Institute Thomas G. Brott, MD Professor of Neurology Dean for Research Mayo Clinic Mark D. Grant, MD, MPH Director Technology Evaluation Center Blue Cross Blue Shield Association William A. Gray, MD Director Endovascular Services Columbia University Medical Center New York-Presbyterian Hospital Assistant Professor of Clinical Medicine Columbia University College of Physicians and Surgeons Columbia University Medical Center Wesley S. Moore, MD Professor and Chief Emeritus Division of Vascular Surgery David Geffen School of Medicine at UCLA Gonda (Goldschmied) Vascular Center CMS Liaison Louis Jacques, MD Director Coverage and Analysis Group Executive Secretary Maria Ellis Coverage and Analysis Group Speakers List: Medicare Evidence Development & Coverage Advisory Committee January 25, 2012 SPEAKER LIST *4 MINUTES PER SPEAKER* Timothy P. Murphy, MD , FSIR, FAHA, FSVMB , President, Society of Interventional Radiology – No Powerpoint Presentation Joshua A. Beckman, MD , President, Society for Vascular Medicine - No Powerpoint Presentation Peter Gloviczki, MD, The Joe M. and Ruth Roberts Professor of Surgery, Chair Emeritus,Division of Vascular and Endovascular Surgery, Director Emeritus, Gonda Vascular Center, Mayo Clinic Donald Heck, MD , Representing: The Society of NeuroInterventional Surgery Daniel Clair, MD , Chairman, Department of Vascular Surgery, Professor of Surgery, Cleveland Clinic Lerner, College of Medicine Julie Freischlag, MD , The William Stewart Halsted Professor, Chair, Department of Surgery, Surgeon-in-Chief, The Johns Hopkins Hospital Richard P. Cambria, MD , President, Society for Vascular Surgery, Chief, Division of Vascular and Endovascular Surgery, Massachusetts General Hospital, Professor of Surgery, Harvard Medical School, Boston, MA Robert M. Zwolak MD, PhD , Section of Vascular Surgery, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire Kenneth Rosenfield, MD, FACC , Representing: The American College of Cardiology John J. Ricotta, MD, FACS , Secretary, Society for Vascular Surgery, Professor of Surgery, Georgetown University, Chair of Surgery, Washington Hospital Center Charles Simonton, MD , Chief Medical Officer, Abbott Vascular John A. Wilson, MD, FACS , Department of Neurosurgery, Wake Forest University School of Medicine, Representing: The American Association of Neurological Surgeons/ Congress of Neurological Surgeons Ty Collins, MD, FSCAI , Chairman of SCAI’s Carotid and Neurovascular Committee & Director of Interventional Cardiology, Ochsner Heart & Vascular Institute, Ochsner Medical Center in New Orleans - No Powerpoint Presentation Download PDF [PDF, 11KB] of speakers list Technology Assessment: Angioplasty and Stenting of the Cervical Carotid Artery with Embolic Protection of the Cerebral Circulation