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

Transcription

1 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, Cardiology Section Philadelphia VA Medical Center Philadelphia, PA Disclosures Research Grants: 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 1

2 Agenda Why is there confusion; why this talk? What are the Guidelines for primary prevention ICDs? What are the data to support the Guidelines? A few comments about CRT. How do you handle individual patients? Why is there confusion? Why this talk? ACCF/AHA/HRS Device-Based Therapy GL ACCF/AHA HF GL HFSA HF, ESC/EHRA and CCS GLs ACC Performance Measures HRS Statement on ICD indications not represented in clinical trials Appropriate Use Criteria National Coverage Determination (NCD) DOJ Investigation and Resolution Model 2

3 Misunderstandings The waiting time rules for primary prevention ICD implantation do not apply to patients with arrests (secondary prevention). The time after MI which counts for a peri-mi arrhythmia is 48 hours. Arrests thereafter justify secondary prevention implantation. Implantable Cardioverter-Defibrillators I IIa IIb III I IIa IIb III I IIa IIb III ICD therapy is indicated in patients who are survivors of cardiac arrest due to ventricular fibrillation or hemodynamically unstable sustained VT after evaluation to define the cause of the event and to exclude any completely reversible causes. ICD therapy is indicated in patients with structural heart disease and spontaneous sustained VT, whether hemodynamically stable or unstable. ICD therapy is indicated in patients with syncope of undetermined origin with clinically relevant, hemodynamically significant sustained VT or VF induced at electrophysiological study. 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. J Am Coll Cardiol 2012;60:

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5 AVID Primary Endpoint: Overall Survival (unadjusted) Survival ICD AAD p = Months Post Randomization N at risk: Percent Survival: ICD: 89.3% 81.6% 75.4% AAD: 82.6% 75.1% 64.7% The AVID Investigators. N Engl J Med 1997;337:1576. AVID/CASH/CIDS Cumulative Risk of Fatal Events Total mortality Arrhythmic death % Amiodarone ICD Years % Amiodarone ICD Years Connolly al. Eur Heart J 2000;21:

6 Implantable Cardioverter-Defibrillators I IIa IIb III I IIa IIb III I IIa IIb III I IIa IIb III ICD therapy is indicated in patients with LVEF less than or equal to 35% due to prior MI who are at least 40 days post-mi and are in NYHA functional Class II or III. ICD therapy is indicated in patients with nonischemic DCM who have an LVEF less than or equal to 35% and who are in NYHA functional Class II or III. ICD therapy is indicated in patients with LV dysfunction due to prior MI who are at least 40 days post-mi, have an LVEF less than or equal to 30%, and are in NYHA functional Class I. ICD therapy is indicated in patients with nonsustained VT due to prior MI, LVEF less than or equal to 40%, and inducible VF or sustained VT at electrophysiological study. 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. J Am Coll Cardiol 2012;60: 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. 6

7 Multicenter Automatic Defibrillator Implantation Trial II (MADIT-II) Evaluated effect of prophylactic ICD therapy on survival in patients with prior MI and LVD. Entry Criteria: Chronic CAD with prior MI and LVEF 0.30 No requirement for NSVT or EPS No upper age limitation Excluded if: MI <1 month Revascularization <3 months NYHA Class IV at enrollment Advanced organ system disease Survival in MADIT II 1.0 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:

8 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: Defibrillator in AMI Trial DINAMIT Arrhythmic Death Nonarrhythmic Death Hohnloser et al. N Engl J Med 2004;351:

9 Immediate Risk-Stratification Improves Survival (IRIS) Study N=902 patients Randomized comparison of ICDs vs. OMT 5-31 days after MI LVEF 40%, HR >90 +/- NSVT Steinbeck G, et al. N Engl J Med 2009;361: Probability of Survival Is Waiting a bad thing? Survival in MADIT II Begin to diverge at 9 mos. and continue to separate 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:

10 Recovery of LV Function after Primary PCI for AMI Prevalence of LVEF 40% at discharge and after 6 months Of patients with LVEF 40% on day 3, 24% improved to 40% at 6 months. Improvement in 48% Mean improvement 6% Deterioration in 25% Ottervanger JP, et al. Eur Heart J 2001;22: Incidence and Predictors of EF Improvement to >35% in Patients Undergoing CABG (Minneapolis VAMC) Ejection Fraction, % Peri-operative change in LV Ejection Fraction pre post pre post pre post Overall Improved EF Unchanged EF n=74 n=38 n=36. Koene RJ, et al. AHA Poster S4114, Q3- Methods: Of 2,838 patients who underwent isolated CABG, 375 had echocardiographic assessment of LVEF before (within 6 months) and after (3-24 months) CABG. Of these, 74 (20%) had EF 35% prior to CABG and were examined. Results: Mean preoperative EF 28±6% improved to 36±12% postoperatively (p< 0.001). Conclusion: More than 50% of the ICD-eligible patients who underwent CABG with a preoperative EF 35% improved their EF to >35% after CABG. Results support GL recommendation of reassessing EF 90 days after CABG in patients with low LVEFs. 10

11 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: For NICM, when does the clinical benefit start? Can I implant at 3 versus 9 months? 3 Trials CAT SCD-HeFT DEFINITE 11

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

13 What is the Optimal Waiting Period for NICM? Study (HF duration diagnosis) CAT (HF 9 months) DEFINITE (No duration) N <3 mos >3 mos <9 mos >9 mos 104 No No 458 Yes Yes SCD-HeFT (HF >3 months) 1211 Not evaluated Yes, long after Yes CRT Indications Algorithm Colors correspond to the class of recommenda1ons in the ACCF/AHA Table 1. Benefit for NYHA class I and II pa1ents has been shown in CRT- D trials, and while pa1ents may not experience immediate symptoma1c benefit, late remodeling may be avoided along with long- term HF consequences. There are no trails that support CRT- pacing (without ICD) in NYHA class I and II pa1ents. Thus, it is an1cipated these pa1ents would receive CRT- D unless clinical reasons or personal wishes make CRT- pacing more appropriated. In pa1ents who are NYHA class II and ambulatory class IV, CRT- D may be chosen but clinical reasons and personal wishes may make CRT- pacing appropriate to improve symptoms and quality of life when an ICD is not expected to produce meaningful benefit in survival. J Am Coll Cardiol 2012;60:

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

15 Time to All-Cause Mortality or HF Event LBBB vs non-lbbb Subpopulations 57% RR 32% worse Courtesy of Boston Scientific QRSd and Survival: Meta-analysis Cleland JG, et al. Eur Heart J 2013;on line. 15

16 Very Wide RBBB and CRT Sundaram V, et al. AHA, Risk and Mortality in MADIT II: U-shaped Curve of ICD Efficacy Risk score model from MADIT II Constructed 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 excluded BUN 70 mg/dl and/or Cr 3.0 mg/dl). Goldenberg I, et al. J Am Coll Cardiol 2008;51:

17 Identification and Characterization of Risk Factors for Atrial and Ventricular Arrhythmias in CKD Patients Using an ILR 50 patients on dialysis Excluded patients with LVEF <35%, NYHA IV HF, PM, ICD, h/o VT or syncope Implanted with SJM implantable loop recorder (ILR) Followed 12 ± 4 months, 6 deaths (12%) and 5 were unexpected All SCD events occurred in the 72 hour break between dialysis 2 had autopsies w/o identifiable cause of death; 1 OOH witnessed CA w/o cause found ILRs showed SEVERE BRADYCARDIA AND ASYSTOLE RECORDED in 4 patients Interrogation of the 5 th ILR was refused by the family. Wong MCG, et al. J Am Coll Cardiol 2015;65: Prevalence & Outcomes of Patients Receiving ICDs for PP Not Based on GLs Beth Israel Deaconess Medical Center, Boston 17% received non-gl-based implants NGLB ICDs 12, 45, and 42 da post MI, revascularization or CM diagnosis (7.3% needed PM), respectively 1/125 within 40 day waiting period post MI or 3 mo post revascularization received appropriate therapy Although these patients have similar long-term risk of receiving appropriate ICD therapy compared with patients with GB implants: 1.During waiting periods mandated by clinical practice GLs, risk is very low. 2.Results suggest little need to implant ICDs during waiting periods. Levine YC, et al. Am J Cardiol 2015;115:

18 Prevalence & Outcomes of Patients Receiving ICDs for PP Not Based on GLs Beth Israel Deaconess Medical Center, Boston 17% received non-gl-based implants NGLB ICDs implanted12, 45, and 42 days after MI, revascularization or CM diagnosis (7.3% needed PM), respectively 1/125 within 40 day waiting period post MI or 3 mo post revascularization received appropriate therapy Although these patients have similar long-term risk of receiving appropriate ICD therapy compared with patients with GB implants: During waiting periods mandated by clinical practice GLs, risk very low. Results suggest little need to implant ICDs during waiting periods. Levine YC, et al. Am J Cardiol 2015;115:

19 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. 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? 19

20 1. No MI: Coded as MI but not DOJ Buckets 2. PM/CRT needed, but not yet ICD-qualified 3. Prior ICD: replacement needed w/in excluded time period 4. Associated with : VT >48 hours post MI 5. Technical violation (30-90 da post MI; da post HF Dx) 6. Syncope within waiting period WILL NOT BE PURSUED 7. Bridge to heart transplantation within waiting period 8. Familial conditions: no prohibited time frames 9. CRT: qualifies for CRT & other than waiting period ICD also 10. Previously qualified : WILL BE PURSUED WITH ENFORCEMENT and WITH OPTION FOR MULTIPLE DAMAGES. Why not an ICD <3 months if LV dysfunction prior to MI? Neither DINAMIT nor IRIS specified duration or prior history of LVEF in entry or exclusion criteria. Neither study included revascularization before enrollment in inclusion or exclusion criteria. DINAMIT: 1/3 had prior MI 2/3 had thrombolytic therapy, PCI or both IRIS: 19% had prior MI 72% had PCI 20

21 Prior MI/LV Dysfunction in DINAMIT Present in 32% of control group & 36% of ICD group Associated with 1.7X risk for death from any cause. In ICD group, 51% of the patients with appropriate therapy had prior MI versus 33% of those with no appropriate therapy. Patients with appropriate shocks had more HF (61% vs 49%) at baseline suggesting presence of pre-existing LV dysfunction. Prior LV dysfunction/hf cannot be used to justify early implantation. Dorian P, et al. Circulation 2010;122; Why is there a lack of benefit early post MI? SCD rate reduced with early reperfusion, BB, etc. ICDs convert SCD to non-sudden death. Sudden death mechanisms differ early and late after MI with early increased risk for nonarrhythmic sudden (cardiac) death. ICDs cause non-sudden death and risk counterbalances benefit. ICD implantation (DFT testing) and altered autonomics dilute ICD benefit. 21

22 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. Appropriateness of ICD-CRT: Rating of Indications 7-9: Appropriate care Procedure is generally acceptable and is generally reasonable for the indication 4-6: May be appropriate care ( uncertain ) Procedure may be acceptable and may be reasonable for the indication 1-3: Rarely appropriate care ( inappropriate ) Procedure is not generally acceptable and is not generally reasonable for the indication Does NOT indicate that the procedure should not be performed for that indication Does NOT indicate that the procedure should not be reimbursed for that indication Courtesy of Dr. Andrea Russo 22

23 Primary Prevention: CAD, Prior MI (>40 days) With Ischemic CM Russo AM, et al. J Am Coll Cardiol 2013;61:

24 Viewpoint Conclusions: What are we to do? Practice within the scope of the ICD NCD whenever possible. Conversely, inappropriate practice outside the GLs and AUC should not be tolerated. Physicians who believe that a device is indicated in a situation not covered by the NCD must document their thought process and rationale. Become involved with teaching coders about what we do, what constitutes a MI (not all troponin elevations represent an MI), and clearly state in charts when events occur, such as the diagnosis of heart failure and the initiation of GDMT. Fogel RI, et al. J Am Coll Cardiol 2014;63: Guidelines and Standard of Care As with all clinical practice guidelines, the recommendations in this document focus on treatment of an average patient with a specific disorder and may be modified by patient comorbidities, limitation of life expectancy because of coexisting diseases, and other situations that only the primary treating physician may evaluate appropriately. Epstein AE, et al. J Am Coll Cardiol 2008;51: (Executive Summary). J Am Coll Epstein Cardiol AE, 2008;51:e1-e62. et al. J Am Coll Cardiol 2008;51:e

25 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. 25