Society of Cardiovascular Computed Tomography 2400 N STREET, NW    WASHINGTON, DC 20037 TEL: 202-375-6190     TOLL-FREE: 800-876-4195     FAX: 202-375-6818 EMAIL: INFO@SCCT.ORG     WEBSITE: WWW.SCCT.ORG

                                               

 

 

December 12, 2008

 

 

Sonia D. Chambers, Chair

West Virginia Health Care Authority Board of Directors

100 Dee Drive

Charleston, WV 25311

 

Dear Ms. Chambers:

 

The Society of Cardiovascular Computed Tomography (SCCT) is pleased to provide comments on the West Virginia Health Care Authority’s review of imaging services under the State’s certificate of need (CON) law.  Specifically, our comments address growth in diagnostic imaging services with supplemental information provided on coronary computed tomography angiography (CCTA). 

 

SCCT is the professional medical society devoted exclusively to cardiovascular computed tomography (CCT).  SCCT is an acknowledged and recognized advocate for research, education and clinical excellence in the appropriate use of cardiovascular computed tomography.

 

The mission of SCCT is to:

• Foster optimal clinical effectiveness of CCT/CCTA through professional education, establishment of standards for quality assurance and professional training, and development of evidence-based guidelines to enhance patient care and improve the quality of cardiovascular medical practice
• Ensure state-of-the-art application of CCT/CCTA through training and accreditation
• Support coordinated research efforts to promote further development and applications of CCT
• Serve as the advocate for CCT before policymakers, the public, and other health care organizations
• Cultivate close working relationships with other societies in the fields of Cardiology, Radiology, Vascular Surgery and Vascular Disease

 

Imaging Services Under CON

The SCCT supports the current West Virginia CON provisions for CCTA.  We recognize and applaud the State’s efforts to achieve quality of care while making every effort to control costs.  In this vein, our comments below include reference to the most recent Medicare numbers on utilization of diagnostic imaging services.

 

Utilization

Some members of the stakeholder community repeatedly cite the Medicare Payment Advisory Commission (MedPAC) and Government Accountability Office (GAO) reports on growth in diagnostic imaging services.  The fact is these reports included analyses based on old data.  This distorts current discussions on the provision of imaging services.  More recent data available from the Centers for Medicare and Medicaid Services (CMS) show slowed growth in utilization of diagnostic imaging services. 

 

According to an analysis completed by the American Medical Association Division of Economic and Health Policy Research (April 2008) of CMS working file claims processed in 2007:

* Spending for imaging fell sharply in 2007 (down an estimated $1.8
billion from 2006, or 14%) - this is due largely to cuts mandated by the
Deficit Reduction Act

* Estimated volume/intensity growth per enrollee for advanced
imaging was 5%

 

* Advanced imaging accounted for approximately 5.3% of
total allowed charges

 

* Nuclear (78465 - MPI) charges dropped 13%

 

We believe that these numbers provide a more accurate assessment of the current use of imaging in medical practice.

 

The supplemental material provided in the Appendix to these comments includes a synopsis of the current evidence regarding CCTA.  We hope this additional information on CCTA will be useful should the need arise for detailed and up-to-date information on the clinical utility and cost effectiveness of this modality.

 

Again, we appreciate this opportunity to participate in the West Virginia Health Care Authority’s review of imaging services.  We support the current WV statute regarding CCTA.  If you have questions or require additional information, please contact Carrie Kovar (ckovar@scct.org or 571.271.9320)

 

Thank you for your time and consideration.

 

Sincerely,

 

 

Daniel S. Berman, MD

President

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

APPENDIX

 

 

What is CCTA?

Coronary Computed Tomography Angiography (CCTA) is the most accurate, non-invasive diagnostic imaging tool used to detect and exclude coronary artery disease (CAD), the most common type of heart disease.  Heart disease remains the leading killer of men and women in this nation.

 

CCTA is a Proven Technology

CCTA is a proven technology to rule out heart disease with 99% accuracy.  This technology is used in over 2000 centers nationwide and has been approved by local Medicare carriers in all 50 states.  CCTA has been readily adopted by the scientific community, in large part, due to positive data from numerous peer-reviewed scientific studies that indicate its efficacy as a non-invasive method to exclude coronary heart disease and avoid unnecessary downstream testing and/or invasive procedures.  

 

Diagnostic accuracy of coronary computed tomography angiography (CCTA)

Two landmark trials have assessed the diagnostic performance of CCTA in prospective multi-center trials.  The ACCURACY trial, recently published in the Journal of the American College of Cardiology, evaluated 230 chest pain patients by CCTA who were being referred for elective coronary angiography at 16 centers.  In this study, the prevalence of obstructive coronary artery stenosis was 14%.  Two important observations should be noted:  1) in this population of patients being referred for invasive coronary angiography—in large part, due to abnormal stress tests—the prevalence of obstructive coronary artery disease was low, reflecting the inadequacy of current diagnostic testing for identifying which individuals would benefit most from further invasive testing; 2) the diagnostic performance of CCTA within the ACCURACY trial was performed on a cohort of individuals with an intermediate prevalence of coronary artery disease.   In this population with a low-to-intermediate prevalence of coronary artery stenosis, CCTA demonstrated a sensitivity, specificity, PPV and NPV of 94%, 83%, 48%, 99%, respectively, to identify a >70% stenosis compared to QCA at the per-patient level.

 

Similarly, the CORE64 trial, presented at the American Heart Association 2007 Scientific Sessions, enrolled 291 primarily high risk patients >40 years of age from 9 centers who were electively referred for invasive coronary angiography.  In this study of individuals with coronary artery calcium scores <600, diagnostic performance of CCTA was assessed for all coronary vessels >1.5mm. In this group with an overall prevalence of obstructive CAD of 51%, CCTA demonstrated a sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) to detect a >50% luminal stenosis by quantitative coronary angiography (QCA) of 85%, 90%, 91% and 83%.

These prospective multicenter trials confirm the high diagnostic performance of CCTA that has been identified in >50 single center studies.  The sensitivity and specificity of CCTA in these trials exceeds those of any other non-invasive diagnostic modality. Furthermore, the exceptionally high NPV of CCTA in populations with low-to-intermediate prevalence of obstructive coronary artery stenosis establishes it as a highly effective non-invasive alternative to exclude the presence of obstructive coronary artery stenosis in symptomatic patients with chest pain.

 

Key Finding: CCTA is the most accurate non-invasive diagnostic modality for the detection and, of equal import, exclusion of CAD in chest pain patients.

 

 

Clinical significance of a negative CCTA

Given the high negative predictive value of coronary CCTA to exclude coronary artery stenosis, several studies have evaluated the ability of CCTA to identify symptomatic patients with suspected CAD who may require NO further testing.

 

Min JK, Shaw LJ, Devereux RB, et al. Prognostic value of multidetector coronary computed tomographic angiography for prediction of all-cause mortality. JACC 2007; 50: 1161-117. 

            In this study of 1127 low-to-intermediate risk patients followed for 15 months, only 1 death occurred in 333 patients without evident coronary artery plaque (0.24% per year; or 2.4% 10-year risk of death)  Furthermore, CCTA plaque measures of obstructive coronary artery stenosis, plaque location and plaque distribution were all predictive of future all-cause mortality.

 

Key Finding: In low-to-intermediate risk patients, a negative CCTA portends an exceptionally low risk of future death for potentially greater than 12 months.  Furthermore, CCTA plaque measures, including stenosis severity, location and distribution are strongly predictive of future risk of death.

 

Pundziute G, Schuijf JD, Wouter J, Boersma E, de Roos A, van der Wall EE, Bax JJ. Prognostic value of multislice computed tomography coronary angiography in patients with known or suspected coronary artery disease. JACC 2007; 49: 62-70.

            In a study of 100 individuals, the first year rate of major adverse cardiac events (MACE) in patients with normal CCTA (no coronary atherosclerosis) was 0%.  Conversely, the rate of revascularization was 30 percent and the rate of hard cardiovascular events was 5 percent within one year in individuals with CCTA-identified coronary atherosclerotic plaque.

 

Key Finding: In patients with suspected CAD, a negative CCTA portends an exceptionally low risk of future MACE in the first 12 months.  Furthermore, CCTA plaque measures including stenosis severity and location are predictive of future risk of MACE.

 

Lesser JR, Flygenring B, Knickelbine T, Hara H, Henry J, Kalil A, Pelak K, Lindberg J, Pelzel J, Schwartz RS.  Clinical utility of coronary CT angiography: coronary stenosis detection and prognosis in ambulatory patients. Catheter Cardiovasc Interv. 2007;69:64-72.

            In this retrospective study of 994 patients with chest pain syndrome or equivocal stress tests who underwent CCTA, only 160 patients required further evaluation with invasive coronary angiography at a 6 month follow-up.  Notably, amongst the remaining patients judged not to require invasive coronary angiography by CCTA, only 2 patients with obstructive coronary artery stenosis required invasive coronary angiography in follow up.

 

Key Finding: In patients with chest pain syndrome or equivocal stress tests and no coronary artery stenosis >50% by CCTA, 6 month outcomes are very favorable with exceptionally low rates of further downstream invasive coronary angiography rates.

 

Cost Containment and Reductions in Resource Utilization by CCTA

Numerous contemporary studies have addressed the ability of CCTA to safely reduce resource utilization and overall healthcare costs.

 

Min JK, Shaw LJ, Berman DS, Gilmore A, Kang N. Costs and clinical outcomes in individuals without known coronary artery disease undergoing coronary computed tomographic angiography from an analysis of Medicare category III transaction codes. Am J Cardiol. 2008;102:672-8.

            A recent study evaluated Medicare category III T-code use of CCTA dedicated to coronary artery evaluation for costs and clinical outcomes.  In a multi-center observational cohort study embodying >10 million insured lives, 142,535 adults were identified who underwent either CCTA (n=3676) or single-photon emission computed tomography myocardial perfusion imaging (SPECT MPI) (n=138,859).  Accounting for potential confounders, CCTA patients (n=2313) were matched 1:4 to SPECT patients (n=9252) for age, demographics, cardiovascular risk factors, baseline co-morbidities, health plan type and Medicare Advantage status.  In a 9 month follow-up of intermediate risk adults undergoing CCTA, cost savings were identified for adults without known CAD by an average of $445 compared to matched adults undergoing SPECT.  Despite these cost differences, no differences were noted with regard to rates of CAD-related hospitalization, incident myocardial infarction or angina.

 

Key Finding:  After the introduction of Medicare category III T-codes, the use of CCTA in intermediate risk individuals without known CAD, as compared to SPECT, is cost-efficient.

 

Min JK, Kang N, Shaw LJ, Devereux RB, Robinson M, Lin F, Legorreta AP, Gilmore A. Costs and clinical outcomes after coronary multidetector CT angiography in patients without known coronary artery disease: comparison to myocardial perfusion SPECT. Radiology. 2008;249:62-70.

            A similar analysis was performed examining adults without known CAD undergoing CCTA under coronary heart disease-specific chest CT angiography with and without contrast (CPT 71275) between 2002-5. (14)  CCTA patients (1,833) patients undergoing SPECT MPI (n=7,332) for age, demographics, cardiovascular risk factors, and cardiac-related medications.  In this low risk group of patients, CAD-related costs for adults undergoing CCTA were $1716 (95% CI, $361-$4,649) lower than in matched adults undergoing SPECT MPI.  Despite overall total healthcare and CAD-related costs, CCTA adults incurred slightly lower rates of CAD-related hospitalization (0.01 vs. 0.02, p=0.003) and myocardial infarction or angina (0.05 vs. 0.08, p<0.0001). 

 

Key Finding:  The use of CCTA in low-risk individuals without known CAD, as compared to SPECT, is cost-efficient.

 

Danciu SC, Herrera CJ, Stecy PJ, Carell E, Saltiel F, Hines JL. Usefulness of multislice computed tomographic coronary angiography to identify patients with abnormal myocardial perfusion stress in whom diagnostic catheterization may be safely avoided. Am J Cardiol. 2007;100:1605-8.

            A recent study of 421 patients with suspected CAD was performed to establish whether CCTA could act as an effective ‘gatekeeper’ to the use of invasive coronary angiography (ICA) in symptomatic patients with intermediate risk after SPECT. Subjects with intermediate risk after SPECT MPI underwent CCTA, and if severe stenosis or moderate stenosis matching a perfusion defect was found, ICA was performed. Main outcome measures were number of patients sent for ICA, immediate revascularization after ICA, and adverse outcomes (death, myocardial infarction, and late revascularization). After SPECT-CCTA assessment, only 78 patients (18.5%) were sent for ICA and 343 (81.5%) were medically managed. Follow-up was 15 ± 3 months. In the group referred for ICA, there were 50 cases of immediate revascularization, 1 non-ST-segment elevation myocardial infarction, 1 death, and 5 patients requiring repeat ICA, 3 of whom underwent late revascularization. In the medically managed group, 6 patients required late ICA, 1 of whom underwent revascularization.

 

Key Finding:  In symptomatic patients with suspected CAD and intermediate-risk SPECT MPI results, CCTA can identify up to 80% of patients at low risk of events in whom ICA may be safely avoided.

 

Cole J, Chunn VM, Morrow A, Buckley RS, Phillips GM. Cost implications of initial computed tomography angiography as opposed to catheterization in patients with mildly abnormal or equivocal myocardial perfusion scans. JCCT 2007; 1:21-26

            In a similar study of 206 patients with mildly abnormal or equivocal nuclear SPECT exams, patients underwent CCTA imaging first, undergoing invasive angiography selectively only if obstructive coronary artery stenosis was identified by CCTA. Amongst the patient cohort, only 32% of patients possessed obstructive coronary artery plaque by CCTA and only these adults underwent selective catheterization, resulting in a cost savings of $1,454 per patient.

 

Key Finding:  CCTA performed in individuals with mildly abnormal or equivocal SPECT MPI exams reduces the need for invasive coronary angiography and results in cost-savings.

 

Utility of CCTA in Acute Chest Pain Patients Presenting to the Emergency Department

Goldstein JA, Gallagher MJ, O'Neill WW, Ross MA, O'Neil BJ, Raff GL.  A randomized controlled trial of multi-slice coronary computed tomography for evaluation of acute chest pain.  JACC. 2007;49:863-71.

            In a recent randomized trial of 197 low risk patients, 99 patients were randomized to CCTA and compared to 98 patients who underwent standard of care that included SPECT imaging.  While both methods were shown to be 100% safe, CCTA immediately excluded or identified coronary artery stenosis as the source of chest pain in 75% of patients.  The CCTA approach resulted in reduced diagnostic time in the emergency department, significantly lower costs, and fewer repeat evaluations for recurrent chest pain during 6 month follow up.

 

Key Finding:  CCTA use in low-risk patients presenting with acute chest pain in the emergency department results in reduced diagnostic time, cost-savings, fewer repeat evaluations for chest pain, and is very safe.

 

Hoffmann U, Nagurney JT, Moselewski F, Pena A, Ferencik M, Chae CU, Cury RC, Butler J, Abbara S, Brown DF, Manini A, Nichols JH, Achenbach S, Brady TJ.  Coronary multidetector computed tomography in the assessment of patients with acute chest pain.  Circulation. 2006; 114:2251-60.Erratum in: Circulation. 2006 Dec 19;114:e651.

            In a blinded, prospective study of 103 consecutive low-to-intermediate risk patients who presented to the ED with acute chest pain without ECG changes and negative initial biomarkers, CCTA exclusion of obstructive coronary artery stenosis identified the absence of acute coronary syndrome with 100% accuracy.  Furthermore, addition of coronary artery plaque identification by CCTA incrementally improved identification of patients experiencing acute coronary syndrome in a manner incremental to traditional risk factors or clinical estimates.  In individuals CCTA-identified non-obstructive or absent coronary artery plaque, no adverse outcomes during a 5.2 month follow up.

 

Key Finding:  CCTA exclusion of obstructive coronary artery plaque excludes the presence of acute coronary syndrome with very high accuracy.  Furthermore, CCTA-identified obstructive plaque predicts the occurrence of acute coronary syndrome in a manner incremental to traditional risk factors and clinical estimates.

 

Rubinshtein R, Halon DA, Gaspar T, Jaffe R, Goldstein J, Karkabi B, Flugelman MY, Kogan A, Shapira R, Peled N, Lewis BS.  Impact of 64-slice cardiac computed tomographic angiography on clinical decision-making in emergency department patients with chest pain of possible myocardial ischemic origin.  Am J Cardiol. 2007;100:1522-6.

            In a prospective study of 58 intermediate risk patients presenting with chest pain and no new ECG changes and negative enzymes, no or minimal coronary artery plaque as identified by CCTA, rates of major adverse cardiovascular events was low and prognosis was favorable in a 12-month follow-up.   

 

Key Finding:  In symptomatic intermediate risk patients presenting to the emergency department, CCTA exclusion of obstructive coronary artery plaque predicts favorable outcomes at 12 months.

 

Additional Evidence in Development

Given the recent introduction of 64-detector row CCTA in 2005, the wealth of scientific evidence that has been developed to date is considerable.  Nevertheless, the SCCT is committed to developing a more expansive evidence base.  As such, the SCCT is committed to supporting investigations which critically evaluate the clinical utility and cost efficiency of CCTA.  At present, many such high quality investigations have been conducted and/or proposed.

 

The Coronary Computed Tomography for Systematic Triage of Acute Chest Pain Patients to Treatment (CT-STAT) trial is a multi-center randomized trial of 750 low risk individuals presenting to the emergency department at 15 hospitals with acute chest pain.  Patients will be randomized to a CCTA-guided strategy and compared to those randomized to standard of care, which will utilize myocardial perfusion imaging.  Enrollment for the CT-STAT trial has recently completed, and follow-up is now being finalized for clinical and economic outcomes.  Similarly, the Rule Out Myocardial Ischemia/Infarction Using Computer Assisted Tomography (ROMICAT II) trial, is a 1000 patient randomized trial at 7 medical centers that will evaluate symptomatic intermediate risk individuals in the emergency department setting.

 

In contrast, the Functional or Anatomic or Both Functional and Anatomic Testing in Symptomatic Individuals Undergoing EvaLuation by MPS or CCTA:  Costs and Clinical OUtcomeS, (FABULOUS) trial, is a multi-center randomized trial of 15,000 intermediate-risk individuals presenting to the outpatient cardiologists’ office with stable chest pain syndrome.  This trial has been proposed to the NHLBI for further consideration of funding.  The major outcomes of this study will be clinical and economic outcomes, as well as quality of life and safety.

           

Given the ACCF Appropriateness Criteria indicating the appropriateness of CCTA after an equivocal stress test, one proposed randomized trial, entitled, Computed Tomographic Coronary Angiography before Invasive Risk Stratification with Traditional Angiography (CTA-FIRST), will examine whether CCTA can serve as an effective ‘gatekeeper’ to invasive coronary angiography with major clinical outcomes evaluated.

 

Much research is also being performed examining CCTA safety.    The ongoing Prospective Randomized Trial On RadiaTion Dose Estimates Of CT AngIOgraphy In PatieNts Scanned With A 100kV Protocol (PROTECTION-II) study, is a study which will evaluate the use of a 100kV protocol (lower radiation dose) for diagnostic image quality, in numerous international sites.