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12/18/15
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
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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
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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
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.
I I I IIa IIa IIa IIb IIb IIb III III III I I I IIa IIa IIa IIb IIb IIb III III III I I I IIa IIa IIa IIb IIb IIb III III III IIa IIa IIa IIb IIb IIb III III III
I I I IIa IIa IIa IIb IIb IIb III III III I I I IIa IIa IIa IIb IIb IIb III III III I I I IIa IIa IIa IIb IIb IIb III III III IIa IIa IIa IIb IIb IIb III III III
I I I IIa IIa IIa IIb IIb IIb III III III I I I IIa IIa IIa IIb IIb IIb III III III I I I IIa IIa IIa IIb IIb IIb III III III IIa IIa IIa IIb IIb IIb III III III
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;60:1297-1313.
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http://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId= 110&ncdver=3&NCAId=148&NcaName=Implantable+Defibrillators&IsPopup=y&bc=AAAAAAAAEAAA&
http://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId= 110&ncdver=3&NCAId=148&NcaName=Implantable+Defibrillators&IsPopup=y&bc=AAAAAAAAEAAA&
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AVID Primary Endpoint: Overall Survival (unadjusted)
Months Post Randomization
Surv
ival
0.0
0.2
0.4
0.6
0.8
1.0
0 12 24 36
ICD AAD
Percent Survival: ICD: 89.3% 81.6% 75.4%
AAD: 82.6% 75.1% 64.7%
N at risk: 1016 645 336 106
p = 0.012
The AVID Investigators. N Engl J Med 1997;337:1576.
Years
%
0 1 2 3 4 5 60
10
20
30
40
50
60
AVID/CASH/CIDS Cumulative Risk of Fatal Events
Total mortality Arrhythmic death
Amiodarone
Amiodarone ICD
ICD
Years
%
0 1 2 3 4 5 60
10
20
30
40
50
60
Connolly al. Eur Heart J 2000;21:2071.
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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.
I I I IIa IIa IIa IIb IIb IIb III III III I I I IIa IIa IIa IIb IIb IIb III III III I I I IIa IIa IIa IIb IIb IIb III III III IIa IIa IIa IIb IIb IIb III III III
I I I IIa IIa IIa IIb IIb IIb III III III I I I IIa IIa IIa IIb IIb IIb III III III I I I IIa IIa IIa IIb IIb IIb III III III IIa IIa IIa IIb IIb IIb III III III
I I I IIa IIa IIa IIb IIb IIb III III III I I I IIa IIa IIa IIb IIb IIb III III III I I I IIa IIa IIa IIb IIb IIb III III III IIa IIa IIa IIb IIb IIb III III III
I I I IIa IIa IIa IIb IIb IIb III III III I I I IIa IIa IIa IIb IIb IIb III III III I I I IIa IIa IIa IIb IIb IIb III III III IIa IIa IIa IIb IIb IIb III III III
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.
Implantable Cardioverter-Defibrillators
J Am Coll Cardiol 2012;60:1297-1313.
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.
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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
Moss AJ, et al. N Engl J Med 2002;346:877-883.
ICD
Conventional
P = 0.007
1.0
0.9
0.8
0.7
0.6
0.0
Probability of Survival
0 1 2 3 4 Year
Survival in MADIT II
No. At Risk Defibrillator 742 502 (0.91) 274 (0.84) 110 (0.78) 9 Conventional 490 329 (0.90) 170 (0.78) 65 (0.69) 3
Reduction in death rate with ICD Rx: 12% at 1 yr, 28% at 2 yrs, 28% at 3 yrs
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For patients post MI, can I implant within 40 days after the event?
Defibrillator IN AMI Trial
Hohnloser SH, et al. N Engl J Med 2004;351:2481-2488.
• 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)
Defibrillator in AMI Trial DINAMIT
Nonarrhythmic Death Arrhythmic Death
Hohnloser et al. N Engl J Med 2004;351:2481-2488.
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Immediate Risk-Stratification Improves Survival (IRIS) Study
Steinbeck G, et al. N Engl J Med 2009;361:1427-36.
• Randomized comparison of ICDs vs. OMT 5-31 days after MI • LVEF ≤40%, HR >90 +/- NSVT
N=902 patients
Moss AJ, et al. N Engl J Med 2002;346:877-883.
ICD
Conventional
P = 0.007
1.0
0.9
0.8
0.7
0.6
0.0
Probability of Survival
0 1 2 3 4 Year
Is Waiting a bad thing? Survival in MADIT II
No. At Risk Defibrillator 742 502 (0.91) 274 (0.84) 110 (0.78) 9 Conventional 490 329 (0.90) 170 (0.78) 65 (0.69) 3
Reduction in death rate with ICD Rx: 12% at 1 yr, 28% at 2 yrs, 28% at 3 yrs
Begin to diverge at 9 mos. and continue to separate
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Recovery of LV Function after Primary PCI for AMI
Ottervanger JP, et al. Eur Heart J 2001;22:785-790.
• Of patients with LVEF ≤40% on day 3, 24% improved to ≥40% at 6 months.
• Improvement in 48% • Mean improvement 6%
• Deterioration in 25%
Prevalence of LVEF ≤40% at discharge and after 6 months
Incidence and Predictors of EF Improvement to >35% in Patients
Undergoing CABG (Minneapolis VAMC)
0
10
20
30
40
50
60
70
pre post pre post pre post
Ejec
tion
Frac
tion,
%
Overall Improved EF Unchanged EF n=74 n=38 n=36 .
Peri-operative change in LV Ejection Fraction
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. Koene RJ, et al. AHA Poster S4114, 2015.
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MADIT II: Time Dependence of ICD Implantation After
Coronary Revascularization • 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;47:1811-7.
Conventional Rx ICD
For NICM, when does the clinical benefit start? Can I
implant at 3 versus 9 months?
3 Trials • CAT • SCD-HeFT • DEFINITE
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CAT 1991-1997
DEFINITE 1998-2003
SCD-HeFT 1997-2001
Protocol OMT OMT +ICD
OMT OMT +ICD
OMT OMT +ICD OMT + amiodarone
n 104 458 2521
Entry Criteria NYHA II-III LVEF ≤30% Age 18-70 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
NIDCM Primary Prevention Trials
• NYHA II-III chronic, stable CHF • LVEF ≤0.35 • CHF ≥3 months
SCD-HeFT (NIDCM cohort)
Bardy G, et al. N Engl J Med 2005;352:225-237.
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What is the Optimal Waiting Period for NICM?
Study (HF duration diagnosis)
N <3 mos >3 mos <9 mos >9 mos
CAT (HF ≤9 months)
104 No No
DEFINITE (No duration)
458 “Yes” “Yes”
SCD-HeFT (HF >3 months)
1211 Not evaluated
Yes, “long” after Yes
CRT Indications Algorithm
J Am Coll Cardiol 2012;60:2604-5.
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.
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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
• 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;361:1329-38.
34% RR 57% RR
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Time to All-Cause Mortality or HF Event LBBB vs non-LBBB Subpopulations
Courtesy of Boston Scientific
57% RR 32% worse
QRSd and Survival: Meta-analysis
Cleland JG, et al. Eur Heart J 2013;on line.
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Sundaram V, et al. AHA, 2015.
Very Wide RBBB and CRT
Risk and Mortality in MADIT II: U-shaped Curve of ICD Efficacy
Goldenberg I, et al. J Am Coll Cardiol 2008;51:288-296.
• 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).
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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 5th ILR was refused by the family.
Wong MCG, et al. J Am Coll Cardiol 2015;65:1263-1265.
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
Levine YC, et al. Am J Cardiol 2015;115:1539-1544.
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.
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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
Levine YC, et al. Am J Cardiol 2015;115:1539-1544.
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.
http://www.modernhealthcare.com/article/20120721/MAGAZINE/307219994#
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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 evidence- based medicine, why shouldn’t they?
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: WILL BE PURSUED WITH ENFORCEMENT and WITH OPTION FOR MULTIPLE DAMAGES.
DOJ “Buckets” 1. No MI: Coded as MI but not 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; 67-90 da post HF Dx)
6. Syncope within waiting period
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 NOT BE PURSUED
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
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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;2645-2652.
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 non-arrhythmic sudden (cardiac) death.
• ICDs cause non-sudden death and risk counter-balances benefit.
• ICD implantation (DFT testing) and altered autonomics dilute ICD benefit.
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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
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Primary Prevention: CAD, Prior MI (>40 days) With Ischemic CM
Russo AM, et al. J Am Coll Cardiol 2013;61:1318-68.
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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;63:12-14.
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:e1–62.
Epstein AE, et al. J Am Coll Cardiol 2008;51:2085-2105 (Executive Summary). J Am Coll Cardiol 2008;51:e1-e62.
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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.