Guidelines/Appropriateness ARCH 2015 St Louis, Missouri April 9-11, 2015 Manish A. Parikh, MD, FACC,FSCAI

Transcription

1 Guidelines/Appropriateness ARCH 2015 St Louis, Missouri April 9-11, 2015 Manish A. Parikh, MD, FACC,FSCAI Center for Interventional Vascular Therapy Columbia University Medical Center / New York Presbyterian Hospital

2 Financial Disclosures Advisory Board: Philips, ABV, Medtronic SB: Philips, ABV, Medtronic, BSc

3 Definition of appropriate coronary revascularization Coronary revascularization is appropriate when the expected benefits, in terms of survival or health outcomes (symptoms, functional status, and/or quality of life) exceed the expected negative consequences of the procedure Patel MR, et al. JACC 2012 ;59(9):857-81

4 Reasons for Establishing Appropriate Use Criteria (AUC) Appropriateness criteria are designed to examine the use of diagnostic and therapeutic procedures to support efficient use of medical resources during the pursuit of quality medical care. To Establish Best Practice Standards Improving quality of care Reducing variability in care (possibly reducing costs of care) Extend beyond the guidelines to scenarios that may be more commonly encountered in clinical practice Patel et al, JACC 2009

5 Health Expenditures, Average spending on health per capita ($US PPP) United States Canada France Germany Netherlands United Kingdom Data: OECD Health Data 2009 (June 2009).

6 Regional Variation in Health Care Costs and Spending Growth Fisher et al, NEJM 2009

7 But How Many Inappropriate PCI s Were Really Getting Done? 4.1%! Wall Street Journal, July 6, 2011 Data from P. Chan et al, JAMA 2011

8 Drivers of AUC: Patient Protection and Affordable Care Act Federal statute, March 23, 2010 Expand Medicaid eligibility Subsidize insurance premiums Incentivize businesses to provide health care benefits Prohibit denial of coverage/claims based on pre-existing conditions Establish health insurance exchanges Support medical research Source: Wikipedia.com And no, they were not drunk when they wrote this law

9 Appropriateness Criteria for Coronary Revascularization: Methodology Scenarios scored by a technical panel (17 members with diverse backgrounds in a modified Delphi exercise) on a scale of 1-9. Scores 7-9: Appropriate: revascularization likely to improve health outcomes or survival Scores 4-6: Uncertain: likelihood that revascularization would improve health outcomes or survival was considered uncertain Scores 1-3: Inappropriate: revascularization unlikely to improve health outcomes or survival Patel, et al. JACC 2009; 53:

10 The New Semantics of the AUC: A R(evolutionary) Change Appropriate Uncertain Inappropriate Appropriate May be Appropriate Rarely Appropriate Removing the harmful/overuse connotation of Inappropriate is a very important modification to the AUC! ACC communication: November 15, 2012

11 AUC Terminology Based on published RAND/UCLA documents. Appropriate does not mean mandatory May be Appropriate * does not mean inappropriate or questionable and is reimbursable Rarely Appropriate does not mean fraud? deceit? Goal is not 0%, however, a consistent inappropriate patterns should be reviewed by physician practices

12 Clinical Presentation Severity of Angina Ischemia Tests/Prognostic Factors* Medical Therapy Anatomic Disease Revasc Appropriateness Criteria: Key Inputs STEMI CCS Class IV High risk Max LM + 3v CAD A U Stable angina ASx, CCS Class I None, Low risk None No sig. CAD I * CHF, DM, Low LVEF Patel, et al. JACC 2009; 53:

13 Appropriateness Criteria for Coronary Revascularization 2012 Patel, M. R. et al. J Am Coll Cardiol 2012;59:

14 The Press Have Had a Field Day

15 Appropriate Use Criteria for Coronary Revascularization Endorsed by

16 How Strong is the Evidence Base Reflected in the ACC/AHA Guidelines? Class III: 13% Level A: 11% Level C: 47% Class I: 45% Class II: 41% Class of Recommendation Level B: 39% Strength of the evidence Level of Evidence C: Estimate of the certainty of the treatment effect Expert Consensus, case studies, standard of care Tricoci P et al, JAMA 2009

17 Good Intentions Gone Wrong? Premises of the AUC Document Revascularization is favored when: The presentation is unstable (vs. stable) Symptoms are severe The risk based upon noninvasive testing is higher The anatomy is more complex (e.g. prox LAD) Medical Therapy has not worked Not always easy to sort out CCS I/II vs. III/IV is very problematic Non-invasive testing is far from perfect and may not have been done Coronary anatomy is more complex than that Why must the patient fail 2 antianginals? What about patient preference?

18 Critiques of the AUC

19 Low-Risk Findings on Noninvasive Imaging Study And Asymptomatic (Patients Without Prior Bypass Surgery) Noninvasive testing Symptoms/Rx Burden of disease

20 2012 appropriate use criteria stable patients Inappropriate rating for Anatomically 1-2 vessel disease no proximal LAD or 1 vessel CTO Asymptomatic or Low risk ischemia or no or minimal anti-anginal therapy Bypass graft intervention asymptomatic patient or low risk ischemia LM + multivessel disease patient with a high syntax score

21 Cited Limitations of the AUC Problem Too few experts on AUC Panel Can game angina Cause Impractical to include more, SCAI nominated members, evidence of benefit should be transparent to all Inter-rater reliability of CCSC poor, Interpreted by docs, not patients Solution None needed. Congruence with 85 practicing cardiologists Use the SAQ Stress tests needed to map AUCs Confusion in interpretation of AUC categories Patient preferences not represented Common not to have stress test, Results unknown in hospital, Risk is not reported Uncertain sounds bad Not reliably documented or quantified Need to confirm ischemia before PCI, Need standards to report risk quality indicator Education of categories now changed. All sites should have some Is/RAs Physicians can document these, more research needed Marso et al. JACC Interven 2012; 5 (2)

22 AUC and Multivessel Revascularization Method of Revascularization of Multivessel Coronary Artery Disease Assumes CCS >2 or int/high risk non-invasives CABG Two-vessel CAD with proximal LAD stenosis A A PCI Three-vessel CAD with low CAD burden (i.e., three focal stenosis, low SYNTAX score) Three-vessel CAD with intermediate to high CAD burden (i.e., multiple diffuse lesions, presence of CTO, or high SYNTAX score) A A A U Isolated left main stenosis A U Left main stenosis and additional CAD with low CAD burden (i.e., one to two vessel additional involvement, low SYNTAX score) Left main stenosis and additional CAD with intermediate to high CAD burden (i.e., three vessel involvement, presence of CTO, or high SYNTAX score) A A U I Patel et al, JACC 2012;59:

23 Revascularization to Improve Symptoms With Significant Anatomic ( 50% Left Main or 70% Non-Left Main CAD) or Physiological (FFR 0.80) Coronary Stenoses

24 Next version of AUC - Improving Criteria The matrix structure will be revamped There will be more scenarios asking about the use of FFR The recommendations for antianginals will follow the Stable IHD Guidelines J Am Coll Cardiol 2012;60: Special scenarios will be developed for: Pre-TAVR Pre-solid organ transplant evaluation

25 No mechanism to take a patient directly to cardiac cath SIHD Guideline recommendations

26 Invasive Testing for Diagnosis of CAD in Patients With Suspected SIHD I IIa IIb III New 2014 I IIa IIb III New 2014 Coronary angiography is useful in patients with presumed SIHD who have unacceptable ischemic symptoms despite GDMT and who are amenable to, and candidates for, coronary revascularization. Coronary angiography is reasonable to define the extent and severity of CAD in patients with suspected SIHD whose clinical characteristics and results of noninvasive testing (exclusive of stress testing) indicate a high likelihood of severe IHD and who are amenable to, and candidates for, coronary revascularization.

27 Non-Left Main CAD Revascularization (cont.) I IIa IIb III Modified 2014 I IIa IIb III New 2014 CABG is generally recommended in preference to PCI to improve survival in patients with diabetes mellitus and multivessel CAD for which revascularization is likely to improve survival (3-vessel CAD or complex 2-vessel CAD involving the proximal LAD), particularly if a LIMA graft can be anastomosed to the LAD artery, provided the patient is a good candidate for surgery. A Heart Team approach to revascularization is recommended in patients with diabetes mellitus and complex multivessel CAD.

28 2014 ACC/AHA SIHD Guidelines: UPLM Revascularization for Survival Class Of Recommendation LOE CABG I B PCI IIa For SIHD when low risk of PCI complications and high likelihood of good long-term outcome (e.g., SYNTAX score of 22, ostial or trunk left main CAD), and a signficantly increased CABG risk (e.g., STS-predicted risk of operative mortality 5%) IIb For SIHD when low to intermediate risk of PCI complications and intermediate to high likelihood of good long-term outcome (e.g., SYNTAX score of <33, bifurcation left main CAD) and increased CABG risk (e.g., moderate-severe COPD, disability from prior stroke, prior cardiac surgery, STS-predicted operative mortality >2%) III: Harm For SIHD in patients (versus performing CABG) with unfavorable anatomy for PCI and who are good candidates for CABG B B B

29 LMCA Revascularization in ACS I IIa IIb III PCI to improve survival is reasonable in patients with UA/NSTEMI when an unprotected left main coronary artery is the culprit lesion and the patient is not a candidate for CABG. *In 2010 UA/NSTEMI Guidelines, PCI is Class III in patients who are candidates for CABG (not present in later guidelines) I IIa IIb III PCI to improve survival is reasonable in patients with acute STEMI when an unprotected left main coronary artery is the culprit lesion, distal coronary flow is less than TIMI grade 3, and PCI can be performed more rapidly and safely than CABG.

30 AUC: Predictions 1. AUC are here to stay! Expect AUC to evolve. Content Development methodology Web-based applications 2. AUC will be used in assessment of quality of care Public reporting, Scorecards, Benchmarking, Hospital and physician ratings. 3. Practitioners and Professional societies: Beware of potential abuse of AUC! Payors denying care based on AUC Malpractice based on AUC Sensationalism in medical and lay press

31 The Hope - User Input Enter Patient Data Symptom Data Non-invasive findings Mark Coronary Tree FFR/IVUS/OCT Patient Input: General Ideas of Choices Output : 1.Guideline and AUC criteria 2.Syntax Risk Score 3.PCI ACC/NCDR Risk Score 4.STS Risk Score

32 THANK YOU!