Workingman s Guide to CRT Indications: Making Sense of the Various Guidelines

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1 Workingman s Guide to CRT Indications: Making Sense of the Various Guidelines Andrew E. Epstein, MD Professor of Medicine, Cardiovascular Division University of Pennsylvania Chief, Cardiology Section Philadelphia VA Medical Center Philadelphia, PA

2 Research Grants: Disclosures Biotronik, Boston Scientific, Medtronic, St. Jude Medical Speaker s Bureaus/Honoraria: Biotronik, Boston Scientific, Medtronic, St. Jude Medical Advisor Relationships: Boston Scientific, St. Jude Medical EP Fellowship Program Support: Boston Scientific, Medtronic, St. Jude Medical

3 What are the Various Guidelines? ACCF/AHA/HRS Device-Based Therapy GL ACCF/AHA HF GL HFSA HF and ESC/EHRA GLs Appropriate Use Criteria ACC Performance Measures National Coverage Determination (NCD) DOJ

Writing Committee Members Andrew E. Epstein, MD, FACC, FAHA, FHRS, Chair John P. DiMarco, MD, PhD, FACC, FAHA, FHRS Kenneth A. Ellenbogen, MD, FACC, FAHA, FHRS N.A. Mark Estes, III, MD, FACC, FAHA, FHRS Roger A.

4 Writing Committee Members Andrew E. Epstein, MD, FACC, FAHA, FHRS, Chair John P. DiMarco, MD, PhD, FACC, FAHA, FHRS Kenneth A. Ellenbogen, MD, FACC, FAHA, FHRS N.A. Mark Estes, III, MD, FACC, FAHA, FHRS Roger A. Freedman, MD, FACC, FHRS Leonard S. Gettes, MD, FACC, FHRS Gabriel Gregoratos, MD, FACC, FAHA Alan M. Gillinov, MD, FACC, FAHA Stephen C. Hammill, MD, FACC, FHRS David L. Hayes, MD, FACC, FAHA, FHRS Mark A. Hlatky, MD, FACC, FAHA L. Kristin Newby, MD, FACC, FAHA Richard L. Page, MD, FACC, FAHA, FHRS Mark H. Schoenfeld, MD, FACC, FAHA, FHRS Michael J. Silka, MD, FACC Lynne Warner Stevenson, MD, FACC, FAHA Michael O. Sweeney, MD, FACC J Am Coll Cardiol 2012;60:

5 Cardiac Resynchronization Therapy* in Patients With Severe Systolic Heart Failure I IIa IIb III For patients who have LVEF less than or equal to 35%, a QRS duration greater than or equal to 0.12 seconds, and sinus rhythm, cardiac resynchronization therapy (CRT) with or without an ICD is indicated for the treatment of New York Heart Association (NYHA) functional Class III or ambulatory Class IV heart failure symptoms with optimal recommended medical therapy. I IIa IIb III I IIa IIb III For patients who have LVEF less than or equal to 35%, a QRS duration greater than or equal to 0.12 seconds, and AF, CRT with or without an ICD is reasonable for the treatment of NYHA functional Class III or ambulatory Class IV heart failure symptoms on optimal recommended medical therapy. For patients with LVEF less than or equal to 35% with NYHA functional Class III or ambulatory Class IV symptoms who are receiving optimal recommended medical therapy and who have frequent dependence on ventricular pacing, CRT is reasonable. *All primary SCD prevention ICD recommendations apply only to patients who are receiving optimal medical therapy and have reasonable expectation of survival with good functional capacity for more than 1 year.

Failure Society of America, and Society of Thoracic Surgeons Endorsed by the American Association for

6 2012 ACCF/AHA/HRS Focused Update Incorporated Into the 2008 Guidelines for Device-Based Therapy of Cardiac Rhythm Abnormalities Developed in Collaboration With the American Association for Thoracic Surgery, Heart Failure Society of America, and Society of Thoracic Surgeons Endorsed by the American Association for Thoracic Surgery, Heart Failure Society of America, and Society of Thoracic Surgeons J Am Coll Cardiol 2012;60:

7 J Am Coll Cardiol 2013;62:e147-e239.

Applying Classification of Recommendations and Level of Evidence Modified 2012 Note: The new and modified recommendations from the 2012 DBT Focused Update were graded based on the latest version of

8 Applying Classification of Recommendations and Level of Evidence Modified 2012 Note: The new and modified recommendations from the 2012 DBT Focused Update were graded based on the latest version of the COR/LOE table. All of the unmodified recommendations were graded on the previous COR/LOE table, listed below. A recommendation with Level of Evidence B or C does not imply that the recommendation is weak. Many important clinical questions addressed in the guidelines do not lend themselves to clinical trials. Although randomized trials are unavailable, there may be a very clear clinical consensus that a particular test or therapy is useful or effective. *Data available from clinical trials or registries about the usefulness/ efficacy in different subpopulations, such as sex, age, history of diabetes, history of prior myocardial infarction, history of heart failure, and prior aspirin use. For comparative effectiveness recommendations (Class I and IIa; Level of Evidence A and B only), studies that support the use of comparator verbs should involve direct comparisons of the treatments or strategies being evaluated.

9 Major Changes in 2012 Update 1. Limitation of Class I indication to patients with QRSd 150 ms. 2. Limitation of Class I indication to patients with LBBB. 3. Expansion of the Class I indication to NYHA class II (and with LBBB with QRSd 150 ms). 4. Addition of a Class IIb recommendation for patients with LVEF 30%, ischemic etiology of HF, SR, LBBB with QRSd 150 ms, and NYHA class I symptoms.

10 Recs Modified 2012 Cardiac Resynchronization Therapy in Patients with Severe Systolic Heart Failure I IIa IIb III I IIa IIb III CRT is indicated for patients who have left ventricular ejection fraction (LVEF) less than or equal to 35%, sinus rhythm, LBBB with a QRS duration greater than or equal to 150 ms, and NYHA class II, III, or ambulatory IV symptoms on GDMT. (Level of Evidence: A for NYHA class III/IV; Level of Evidence: B for NYHA class II). 1 I IIa IIb III I IIa IIb III CRT can be useful for patients who have LVEF less than or equal to 35%, sinus rhythm, LBBB with a QRS duration 120 to 149 ms, and NYHA class II, III, or ambulatory IV symptoms on GDMT. 2 CRT can be useful for patients who have LVEF less than or equal to 35%, sinus rhythm, a non-lbbb pattern with a QRS duration greater than or equal to 150 ms, and NYHA class III/ambulatory class IV symptoms on GDMT Modified recommendation from 2008 GL specifying BBB morphology, QRS duration, and expanding to include NYHA class II. 2. New Recommendation

11 Recs Modified 2012 Cardiac Resynchronization Therapy in Patients with Severe Systolic Heart Failure I IIa IIb III CRT may be considered for patients who have LVEF less than or equal to 35%, sinus rhythm, a non-lbbb pattern with QRS duration 120 to 149 ms, and NYHA class III/ambulatory class IV on GDMT. 1 I IIa IIb III I IIa IIb III No Benefit I IIa IIb III No Benefit CRT may be considered for patients who have LVEF less than or equal to 35%, sinus rhythm, a non-lbbb pattern with a QRS duration greater than or equal to 150 ms, and NYHA class II symptoms on GDMT. 1 CRT is not recommended for patients with NYHA class I or II symptoms and non-lbbb pattern with QRS duration less than 150 ms. 1 CRT is not indicated for patients whose comorbidities and/or frailty limit survival with good functional capacity to less than 1 year New Recommendation 2. Modified recommendation from 2008 GL to include cardiac and noncardiac comorbidities.

13 Comparison of Guidelines Prinzen FW, et al. Circulation 2013;128:

14 Canadian Cardiovascular Society Guidelines on the Use of Cardiac Resynchronization Therapy: Evidence and Patient Selection Recommendation Three Strength Quality A CRT pacemaker is recommended for patients who are suitable for resynchronization therapy, but not for an ICD. Strong Moderate Can J Cardiol 2013; 29(2): Exner DV, Birnie DH et al., Canadian Journal of Cardiology, Feb. 2013;29(2): /01/2014 Copyright 2013, Canadian Cardiovascular Society 15

15 Canadian Cardiovascular Society Guidelines on the Use of Cardiac Resynchronization Therapy: Evidence and Patient Selection Recommandation 3 Force Qualité La TRC-C est recommandée pour les patients qui sont admissibles à la thérapie de resynchronisation, mais pas au DCI. Forte Modérée Can J Cardiol 2013; 29(2): Exner DV, Birnie DH et al., Canadian Journal of Cardiology, Feb. 2013;29(2): /01/2014 Copyright 2013, Canadian Cardiovascular Society 16

16 Foundation for the New Recommendations QRS morphology QRS duration AF and outcomes Co-morbidities

17 Slide sent by BS on Approval: Previously Published and Updated Results 34% RR 57% RR MADIT-CRT met its end point in June 2009 and results published in the September 2009 NEJM online. Results showed that CRT-D was associated with a 34% reduction in the relative risk of the primary end point. Primary effectiveness end point achieved. Subsequently discovered and validated that in the LBBB subgroup, patients received substantial benefit from CRT-D. Non-LBBB patients did not show evidence of benefit. The LBBB sub-group made up approximately 70% of the total MADIT- CRT population. Moss AJ, et al. N Engl J Med 2009;361:

18 Time to All-Cause Mortality or HF Event LBBB vs non-lbbb Subpopulations 57% RR 32% worse Courtesy of Boston Scientific

19 Logistic Regression: Factor P-value Rand 0.01 QRS Width 0.08 Rand.*QRS REVERSE. Courtesy of Dr. Michael Gold

20 QRSd and Response to CRT: Meta-regression Analysis Sipahi I, et al. Arch Intern Med 2011, epub 6/13/11

21 QRSd 150 ms Stavrakis S, et al. J Cardiovasc Electrophysiol 2012;23:

22 QRSd <150 ms Stavrakis S, et al. J Cardiovasc Electrophysiol 2012;23:

23 RAFT: AF and CRT Primary Outcome: Death or HF Hospitalization Sinus ICD/CRT Sinus ICD only AF ICD only AF ICD/CRT Healey J, et al. Circulation Heart Failure 2012;5:

24 Comorbidities and Survival Lee et al. J Am Coll Cardiol 2007;49:

25 Risk and Mortality in MADIT II: U-shaped Curve of ICD Efficacy 5 risk factor model Age >70 years NYHA class >II BUN >26 mg/dl QRS duration >120 ms Atrial fibrillation at baseline Very high risk (VHR) patients: BUN 50 mg/dl and/or Cr 2.5 mg/dl (MADIT II exclusion BUN 70 mg/dl and/or Cr 3.0 mg/dl). Goldenberg I, et al. J Am Coll Cardiol 2008;51:

26 Risk Score (PACE) to Predict Early Mortality after ICD Kramer DB, et al. Heart Rhythm 2012;9:42-46.

27 Influence of CKD on Survival Cannizzaro LA, et al. J Am Coll Cardiol 2011;58:

28 Temporal Changes in Non Evidence- Based ICD Implantation 24.5% 21.8% 22.0% 21.7% Al-Khatib SM, et al. JAMA 2011;305:43-49.

30 Why is there confusion? Different Sets of Rules ACC/AHA/HRS Guidelines Recommend treatment of an average patient with a specific disorder. Performance Measures ACC recommends ICD counseling as a quality measure. Appropriate Use Criteria Grade appropriateness of treatment of patients not described in ACC/AHA/HRS GL. National Coverage Determination (NCD) States what is covered by CMS for Medicare patients. DOJ Investigation and Resolution Model Enforcement of a payment policy, not a template on how to practice medicine.

31 Bonow RO, et al. J Am Coll Cardiol 2012;59:

32 HF Performance Measures Bonow RO, et al. J Am Coll Cardiol 2012;59:

AUC publications reflect an effort by the ACCF to critically and systematically create, review, and categorize clinical situations that may or may not be addressed in

33 AUC publications reflect an effort by the ACCF to critically and systematically create, review, and categorize clinical situations that may or may not be addressed in guidelines, and provide management guidance. I m afraid they obfuscate. How do you reconcile the: Guidelines Appropriate Use Criteria Performance Measures NCD (2005) DOJ Resolution Model

34 The DOJ Investigation: ICDs not Pacemakers, CRT or otherwise DOJ launched its investigation 8 years ago, not in response to the 2011 JAMA article. DOJ Rationale: Concern there was ICD implantation for reasons not covered by the National Coverage Determination (NCD). Submitting a bill to Medicare for noncovered procedures can be considered Medicare fraud. Liability is for both individual physicians and their hospitals.

35 Crux of the Problem: Why is there a waiting period post MI, CABG, PCI, and the diagnosis of HF? At the time of initial evaluation Stability of substrate unknown Responses to therapy unknown Device benefit uncertain Waiting periods are based on RCTs that lead to guidelines and coverage decisions by private carriers and CMS/Medicare.

http://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?

36 110&ncdver=3&NCAId=148&NcaName=Implantable+Defibrillators&IsPopup=y&bc=AAAAAAAAEAAA&

37 Proposed Decision Memo May 29, 2013 CRT: Silent

38 Should We Be Surprised by the DOJ, CMS and the National Coverage Determination? Probably not We did the trials. We defined the entry criteria. We generated the data that led to the NCD. Our societies (and we) ask for evidencebased medicine, why shouldn t they?

39 For patients post MI, can I implant within 40 days after the event? Defibrillator IN AMI Trial Randomized comparison of OMT 6-40 days after MI with or without an ICD LVEF 35%, abnormal autonomic function ( HRV or HR >80 bpm on monitoring) Hohnloser SH, et al. N Engl J Med 2004;351:

Is Waiting a bad thing? Survival in MADIT II 1.0 Begin to diverge at 9 mos. and continue to separate Probability of Survival 0.9 0.8 0.

40 Is Waiting a bad thing? Survival in MADIT II 1.0 Begin to diverge at 9 mos. and continue to separate Probability of Survival Conventional ICD Reduction in death rate with ICD Rx: 12% at 1 yr, 28% at 2 yrs, 28% at 3 yrs No. At Risk Year Defibrillator (0.91) 274 (0.84) 110 (0.78) 9 Conventional (0.90) 170 (0.78) 65 (0.69) 3 P = Moss AJ, et al. N Engl J Med 2002;346:

MADIT II: Time Dependence of ICD Implantation After Coronary Revascularization Conventional Rx ICD MADIT II enrollment criteria excluded patients with coronary revascularization within 3 months of MI

41 MADIT II: Time Dependence of ICD Implantation After Coronary Revascularization Conventional Rx ICD MADIT II enrollment criteria excluded patients with coronary revascularization within 3 months of MI 130 patients had PCI and/or CABG 3-6 months (median 4 months) prior to ICD No reduction in all-cause mortality (or SCD) 6 months after revascularization Goldenberg I, et al. J Am Coll Cardiol 2006;47:

42 For DCM, when does the clinical benefit start? Can I implant at 3 versus 9 months? 3 Trials CAT SCD-HeFT DEFINITE

43 NIDCM Primary Prevention Trials CAT DEFINITE SCD-HeFT Protocol OMT OMT +ICD OMT OMT +ICD OMT OMT +ICD OMT + amiodarone n Entry Criteria NYHA II-III LVEF 30% Age years NYHA I-III LVEF <36% NSVT or 10 PVCs/hr NYHA II-III LVEF 0.35 Duration of HF 9 months Not specified 3 months

44 SCD-HeFT NYHA II-III chronic, stable CHF LVEF 0.35 CHF 3 months Bardy G, et al. N Engl J Med 2005;352:

45 What is the Optimal Waiting Period for NICM? Study (HF duration diagnosis) CAT (HF 9 months) N <3 mos >3 mos <9 mos >9 mos 104 No No DEFINITE (No duration) 458 Yes Yes SCD-HeFT (HF >3 months) 1211 Not evaluated Yes, long after Yes

46 Part of the Problem: Coding Disconnect between diagnosis (ACS given by a coder) and reality (no ACS since there was only a troponin leak) Miscoding of timing of onset of HF

47 Suitability of ICD-9 Coding as the Basis for Assessing HF Performance HF Cardiologist HF Nurse Practitioner HF Present HF Absent HF Present HF Absent 37% 10% 4% 49% CKD 36% OSA/PHT 15% COPD 9% These accounted for 1/5 of all readmissions Take Home Message: Hospitals are at risk on quality measure assessment due to inaccurate coding. Patel P, et al. J Am Coll Cardiol 2011;57:E1240.

48 My Opinion and Experience FOLLOW THE GUIDELINES. It s good protection. Do what s right and document it -- you ll be all right. This is especially true in areas of controversy and in the absence of RCT data. We have to be involved with coding education. For private carriers, a call by the responsible physician and not a delegate to the Medical Director will virtually always assure coverage. Although evidence drives GLs, AUC and CMS, GL indications are generally accepted by private carriers, but for CMS the NCD rules.

Implantable Cardioverter- Defibrillators (ICDs) for the Prevention of SCD: Appropriate Use in Disclosures

Implantable Cardioverter- Defibrillators (ICDs) for the Prevention of SCD: Appropriate Use in 2015 Andrew E. Epstein, MD Professor of Medicine, Cardiovascular Division University of Pennsylvania Chief,