Welcome and Overview

1. Welcome and Overview Jan 26-27 2006 Beverly Hills California Ronald P. Karlsberg, MD Clinical Professor of Medicine, David Geffen School of Medicine, UCLA Cardiovascular Medical Group of Southern California

2. Introduction of VCT 64 Multi-detectorAngiography & Clinical Cardiac Applications Cardiovascular Medical Group of Southern California

3. A Real Case: Oct 2005 • 56 year old male with a history of chest pain, elevated cholesterol and hypertension: One month ago underwent short hospitalization in the Colorado Mountains and had a regular treadmill and was discharged. • A Nuclear study was planned but he presented to the office with sub-sternal pressure, indigestion and back pain. The EKG was normal. Discomfort was considered atypical for ischemia but was persistent. • Hospitalization vs. Outpatient evaluation ?

4. Patient with Chest Pain • The CT scan was available and ready. The insurance company (Blue Shield) was promptly called and reimbursement for CT coronary angiography was refused. • The physician advisor came on line, heard the clinical story and indicated that Blue Shield considered CT angiography experimental and confirmed reimbursement would not be offered. • Patient was expediently admitted to the hospital where he underwent coronary angiography and aortography and found to have normal coronaries.

5. Dx of GERD • Patients symptoms resolved on H2 blockers and have not reoccurred. Back pain resolved with anti-inflammatory. • Cost of CT Angiography: $1500 • Cost of admission and Cardiac Cath: >$15,000

6. Why Do Cardiac CT ? CVMG

7. Cardiac Studies • Calcium Score – prognostic implications • CT Coronary Angiography • Axial Images • MIP Imaging • Volume Rendering • Vessel Analysis • Moving images from Volume Rendered Data • Stent assessment • Plaque composition and soft plaque analysis • Cardiac Anatomy • Pericardium, chambers, valves, myocardium • Congenital Heart Disease • Electrophysiology • Pulmonary Vein Analysis for ablation • Pre Biventricular Pacing Catheter Placement • Cardiac Function • Volumes • Ejection Function • Regional Wall Motion and wall thickness • Scaring • Aorta, Peripheral Vascular, Carotid

8. Non- Cardiac Studies • To the extent one performs primary care, either cardiac or internal medicine it makes sense to have CT scanning in the office for comprehensive care • Caveat: maintain impeccable standards and work with, not against the “best of bred” in your “neck of the woods”.

10. What is the Role of CT Angiography in the Office Setting? • Few offices have the infrastructure to afford, organize and support CT angiography. • There remains confusion as to the role CT coronary angiography has in the diagnostic work up of CAD. • There is uncertainty as to the cost benefits by the insurance carriers. • There remain many controversial issues

11. Goals for this Course • Principles and Theories of Acquisition and Interpretation • Observation of actual cases • Anatomy Review (Axial Data) Introduction • Radiation Exposure and MDCT Techniques • Basics of Processing – Introduction to the Work Station • Coronary Calcium Detection. • Case Studies Review with Cath correlation • What else can we can see ? • Electrophysiological and Peripheral CT Angiography. • Review of many cases. • Proctored Interpretation of cases

12. Imaging and Physicians • Diagnostic Imaging is greater than a 100 billion-a-year business, up more than 40% since 2000. • Physician billing for radiology services climbed 75% from 1998 to 2002 and has increased further since then.

13. What Does It Take To Have CT Imaging in Your Office CVMG

14. Vision

15. Vision • To provide the highest quality medical care to the community • To Create a World Class Center of Excellence for Non-invasive coronary imaging with “State of the Art” Equipment and Personnel • To maintain status as a Premier Cardiac Practice • To maintain revenue while other sector such as intervention, nuclear etc continue to drop.

16. Lots of Doctors!! Matthew Budoff, M.D. Ronald Karlsberg M.D.

17. Howard Allen Satinder Bhatia Selvyn Bleifer Neil Buchbinder Matthew Budoff Suhail Dohad Yoran Elad Eli Gang Debra Judelson Ronald P. Karlsberg Harold L. Karpman William J. Mandel Frank Nakano Robert Rose Bruce Samuels Charles Swerdlow Steven Tabak CVMG - Cardiovascular Medical Group of Southern CaliforniaPhysicians

18. Lots of Patients CVMG

19. Primary and Consultative Cardiology Interventional Cardiology Electrophysiology Internal Medicine Cardiac Testing 3 offices 82,568 Patients in data base >3,000 Hospital Procedures >2,000 Nuclear Studies 100-200 Office Visits each day CVMG

20. It Helps to Have Research CVMG

21. CVRI Cardiovascular Research Institute of Southern CaliforniaClinical Research • 15 – 20 Active Studies/ year • CAD, CHF, PVD, Hypertension, Lipid Angiogenesis, Intervention, Angina, MI, etc • 5+ FTE • Experience with over 300 clinical trials • 2005: CT Angiography • A fertile area for clinical research

22. LightSpeed Cardiac VCT vs. Cath Study Protocol • The aim of this study will be to evaluate the accuracy and efficacy of contrast-enhanced coronary artery visualization using a the VCT 64 LightSpeed VCT scanner, to compare its performance to that of conventional X-ray coronary angiography, and to gather necessary clinical and financial data to model the potential impact of this technology on cardiovascular care.

23. Infrastructure and Experience With Technology

24. CVMG – Information Systems • 130 Computers • 3+ FTE and consultants • 15 Servers and deep archive • Integrated Applications • EMR and integrated distribution – NotesMD • Imaging – Medcon • Echo-Acuson • Nuclear-Phillips • Business- Megawest • Lab – Orchard • EP – Pacearts • 24 Hour Holter and BP monitors - Phillips • PAC Order System- Quadris • CT Imaging – GE Imaging • EMAIL, Calendar and Contacts – Microsoft Exchange • Community Functions – Microsoft Sharepoint

25. Himmm do we really have what it takes…..(lets get some other docs)

26. How About A Partner ? CVMG

27. Getting a Partner May Reduce the Downside

28. Legal Constraints • Physicians have restrictions in referring patients to service providers in which they have a financial stake. • Diagnostic imaging services define in “Stark Laws”

29. Lots of Lawyers

30. Formation of Joint Venture Partner Operator Partner Leasing Venture CT Center Cardiology Group Physicians Radiology Group Equipment Leasing Venture owns equipment and leases to operator at a per click fee with reasonable profit in accordance with Stark and State regulations. Operating Entity provides all services Radiology group provides sub-specialty reading of non-cardiac studies

31. ACC CCTA Statement 2006 • High correlation with stenotic lesions at catheterization and with intra-coronary ultrasound • CCTA approval requires expert evidence, performance data, decisions models and consensus base while awaiting additions and revisions based higher level evidence based studies • CCTA can reliable rule out CAD in patients with low to intermediate probability • Can reliable achieve a high degree of diagnostic accuracy and technical performance necessary to replace conventional angiography • CCTA may be proposed or in addition to other non invasive cardiac tests such as equivocal stress myocardial perfusion tests

32. ACC CCTA Statement 2006 continued • Information from CCTA may be used to guide further diagnostic evaluation or therapy (revascularization vs. medical management) • May over the long term influence morbidity of CAD (e.g. angina or subsequent MI) functional status or mortality • CCTA may avoid the morbidity of invasive coronary angiography • CCTA may be proposed in circumstances where invasive coronary angiography may not be clinically indicated.

33. ACC Statement 2006 continued • CCTA never covered for screening, (absence of signs, symptoms or disease). • Order in the context of other testing modalities so that the resulting information facilitates the management decision, not merely adds a new layer of testing. • CCTA may be denied, on post-pay review, as not medically necessary when there is a pre-test knowledge of extensive calcification of the coronary segment in question that would diminish the interpretive value. • Beta blockers and the monitoring of the patient during MDCT by a physician are included and are not separately payable services. • Must be ordered by a physician or a qualified non-physician practitioner • For contrast examinations a physician must be present for direct supervision during testing similar to the stress myocardial perfusion imaging.

34. ACC Recommendations to MedicareIndications • First test to assess the cause of chest pain.    • Triage tool to invasive coronary angiography following a stress test that is equivocal or suspected to be inaccurate.   • To evaluate the cause of symptoms in patients with known coronary artery disease.    • To evaluate the cause of chest pain or dyspnea in patients with prior bypass surgery or intra-coronary artery stent placement.    • Suspected congenital anomalies of the coronary circulation.   • For evaluation of acute chest pain in the emergency room.   • Assessment of coronary or pulmonary venous anatomy  • Prior to non-coronary artery cardiac surgery. • (Aortic Stenosis to evaluate the co-existence of CAD) • (Cardiomyopathy)

35. Technical Requirements of MDCT • The service is performed by a radiologic technologist who is credentialed by a nationally recognized credentialing body (American Registry of Radiologic Technologists or equivalent) and meets state licensure requirements where applicable. • If intravenous beta blockers or nitrates are to be given prior to a CT coronary angiogram or calcium score, the test must be under the direct supervision of a certified registered nurse and physician (familiar with the administration of cardiac medications) who are available to respond to medical emergencies and it is strongly recommended that the certified register nurse and physician be ACLS certified. • When contrast studies are performed, the physician must provide direct supervision and the radiologic technologist or registered nurse administering the contrast must have appropriate training on the use and administration of contrast media.

36. ACC Professional Requirements • The physician has appropriate additional training in CT Coronary Angiography and cardiac CT imaging equivalent to the guidelines set forth by the ACC or ACR (for example: the ACCF/AHA Clinical Competence Statement on Cardiac Imaging with Computed Tomography and Magnetic Resonance (2005) and the ACR Clinical Statement on Noninvasive Cardiac Imaging (2005)), • or The physician has appropriate medical staff privileges to interpret CT Coronary Angiograms at a hospital that participates in the Medicare program, and is actively training in cardiac CT (as in paragraph a). A grace period of 24 months should be allowed to acquire the necessary training.

37. Competency for CT Angiography(Circulation. 2005;112:598-617.) • ACCF/AHA Clinical Competence Statement on Cardiac Imaging With Computed Tomography and Magnetic Resonance • A Report of the American College of Cardiology Foundation/American Heart Association/American College of Physicians Task Force on Clinical Competence and Training: Developed in Collaboration With the American Society of Echocardiography, American Society of Nuclear Cardiology, Society of Atherosclerosis Imaging, and the Society for Cardiovascular Angiography & Interventions: Endorsed by the Society of Cardiovascular Computed Tomography • WRITING COMMITTEE: Matthew J. Budoff, MD, FACC, FAHA, Chair; Mylan C. Cohen, MD, MPH, FACC, FAHA; Mario J. Garcia, MD, FACC; John McB. Hodgson, MD, FSCAI; W. Gregory Hundley, MD, FACC, FAHA*; Joao A. C. Lima, MD, FACC, FAHA; Warren J. Manning, MD, FACC, FAHA**; Gerald M. Pohost, MD, FACC, FAHA; Paolo M. Raggi, MD, FACC; George P. Rodgers, MD, FACC; John A. Rumberger, MD, PhD, FACC; Allen J. Taylor, MD, FACC, FAHA

38. Who Should Interpret CT Coronary Angiography ? • Cardiac Radiologist • Interventional Cardiologist • General Cardiologist • Cardiac Surgeons • “The Cardiac CT Specialist”

39. The Regulation and Reimbursement Hurdles are a Changing Landscape

40. The Status of Reimbursement • Adopt a policy of pre-approval and cash • Have patient sign responsibility statements • This is a moving target • Participate in local and national efforts to justify and achieve reimbursements • Plan that your scanner will work even if Cardiac reimbursement is in flux

41. 0146T CT angiography of coronary arteries (CCTA) (including native and anomalous coronary arteries, coronary bypass grafts), without quantitative evaluation of coronary calcium 0147T CCTA with quantitative evaluation of coronary calcium 0148T Cardiac structure and morphology and CCTA, without quantitative evaluation of coronary calcium 0149T Cardiac structure and morphology and CCTA, with quantitative evaluation of coronary calcium CTA Heart Codes www.ama-assn.org/ama/pub/category/3885 Coronaries alone Coronaries & calcium scoring Coronaries & cardiac morphology Coronaries, cardiac morphology & calcium scoring

42. Calcium scoring only Cardiac morphology only Congenital studies, non-coronary RVEF/ LVEF and wall motion (add-on) 0144T CT, heart, without contrast material, including image postprocessing and quantitative evaluation of coronary calcium 0145T CT, heart, without contrast material followed by contrast material(s) and further sections, including cardiac gating and 3D image postprocessing; cardiac structure and morphology 0150T Cardiac structure and morphology in congenital heart disease 0151T CT, heart, without contrast material followed by contrast material(s) and further sections, including cardiac gating and 3D image postprocessing; function evaluation (left and right ventricular function, ejection fraction, and segmental wall motion) CTA Heart Codes, con’t

43. When to Order CT Angiography?A Balancing Act • Diagnostic Value • Reimbursement • Radiation

44. Glossary of Terms: Radiation • Gray Unit (Gy) is the absorbed patient dose • Sivert (Sv) is the dose equivalent coming from the equipment • One milliSivert (mSV) = 1 milligray (mGy) • One Rad (Roentgen) = 1 rem = 0.01 Gy = 0.01 Sv • Any dose above zero increases risk of cancer with no threshold • 1 SV causes blood changes • 2-5 SV caused nausea and hair loss hemorrhage • More than 6 SV death in less than 2 months in 80%

45. Units of Radiation

46. Relative Exposure due to CT Angiography • If a CT angiogram = 10 mSV • And 6 SV causes death (80%) (i.e. 6000 mSV) • Then 600 CT angiograms (done in close proximity) would cause death in 80% of patients. • Then 100 CT angiograms (performed in close proximity) would cause blood changes.

47. Cath Proponent: C. Richard Conti (Clin.Cardiol. 28, 450-453 (2005) Cath 2.1-2.5 mSv

48. Dose Monitoring in CT • The exposure is available as a dose report for each patient. • CTDIvol (mGy) • A measure of the average dose in the slice • Estimates for organ doses if the whole organ is in the primary scan volume • DLP (mGy·cm) • A measure for the total energy imparted for the complete CT exam, the sum of all series

49. RCA CIR LAD Where Does MDCT Fit ?Cardiac Diagnostic Imaging

50. Glossary of Terms GE (General Electric) • VCT: Volume Computerized Tomography • MSCT: Multi-Slice Computed Tomography • MDCT: Multi-Detector Computed Tomography • TIP: Training In Partnership • CT CardioIQ • Heart Volume Rendering • Cardiac Transparency • Angiographic View • AW: Advantage Workstation • CardioIQ Pro EF: Software of LV analysis • CardEP: • Electrophysiology software for analysis of left atrium and pulmonary veins • Navigator EP • Smart Score: Software for calcium scanning