Guidelines on AICD Implantation for Primary Prophylaxis of Sudden Cardiac Death Implications of the

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Guidelines on AICD Implantation for Primary
Prophylaxis of Sudden Cardiac DeathImplications
of the New CMS Guidelines

• John D. Symanski, MD, FACC

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New CMS Guidelines(Time Table)

• Draft of new guidelines released September 30th,
  2004
• One month period allowed for public review and
  comment
• Final ruling to be issued 60 days from October
  28th, 2004

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CMS Projections

• Anticipated increase in number of eligible
  Medicare beneficiaries by 1/3 to 500,000
• CMS predicts 25,000 new implants next year
• Primary prevention guidelines (apply only to
  single-chamber devices)

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New CMS GuidelinesICD for Primary Prevention

• ICD is reasonable and necessary for patients with
  ischemic DCM, documented prior MI, and LVEF lt 30
• Indicated for patients with non-ischemic DCM of
  greater than nine months duration and measured
  LVEF lt 30
• A provider implanting any ICD other than a single
  lead, shock only device for primary prevention
  must document medical necessity

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New CMS GuidelinesContraindications to ICD
Therapy

• NYHA Class IV heart failure
• Cardiogenic shock or symptomatic hypotension
  while in a stable rhythm
• CABG or PTCA within past 3 months
• AMI within the past month
• Candidate for coronary revascularization
• Irreversible brain damage from CVD
• Disease with life expectancy lt one year

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CMS GuidelinesICD for Primary Prevention

• Criteria for QRS duration no longer apply (except
  for CRT-D device)
• CMS will require a clinical registry with the
  following data
• Baseline patient characteristics
• Facility and provider characteristics
• Extent of disease progression
• Periodic device interrogation for firing data
• Long-term patient outcomes

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Primary Prevention TrialsICD Therapy in Patients
with LV Systolic Dysfunction

• Early Trials
• MADIT
• CABG-Patch
• MUSST
• CAT
• MADIT II

• Recent Studies
• AMIOVIRT
• COMPANION
• DEFINITE
• DINAMIT
• SCD-HeFT

Nanthakumar et al. JACC December 7, 20042166-72
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Meta-Analysis 34 reduction all-cause
mortality Excluding MUSST RR arrhythmic death
0.45, but risk of all-cause mortality NS (p0.12)
Nanthakumar et al. JACC December 7, 20042166-72
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MADIT Multi-center Automatic Defibrillator
Implantation Trial

• High risk patients with ischemic heart disease
• Epicardial leads used in half of patients,
  transvenous leads in half
• Mortality rate 16 in ICD group vs 39 in
  conventional treatment group after 27 months of
  follow-up (59 RR reduction, absolute risk
  reduction 23, p0.009)

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CABG-PatchCoronary Artery Bypass Graft Patch
Trial

• Prophylactic ICD (epicardial patches) placed in
  patients undergoing elective CABG surgery
• Mortality rate 23 in ICD treated patients and
  21 in controls at 32 months (p0.64)

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MUSSTMulti-Center Un-Sustained Tachycardia Trial

• Compared two treatment strategies (EP-guided vs.
  empiric) for patients with CAD and and
  non-sustained VT
• ICD use was not randomized
• 5-year mortality 42 in EP-guided group and 48
  in non-EP-guided group (p0.06)
• Non-randomized comparison of EP-guided patients
  receiving ICD had a 24 mortality at 5 years vs.
  55 in those not receiving device

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MUSST RegistryAll-Cause Mortality in MADIT-II
Like Patients

• 65 over 5 years with QRS gt 120 msec
• 46 over 5 years with QRS lt 120 msec
• 38 (with ICD treatment) QRS gt 120 msec
• 17 (with ICD treatment) QRS lt 120 msec

Packer et al. Heart Rhythm 2004 1 Suppl S24
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CATCardiomyopathy Trial

• Patients with non-ischemic DCM (n104)
• Enrollment terminated early because a very low
  one-year mortality rate for all patients (only
  5.6 as opposed to an anticipated rate of 30)
• After two year follow-up, mortality rate 26 in
  ICD group, 50 in controls (p0.554)

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MADIT II

• Mortality rate 19.8 in conventional treatment
  group and 14.2 in ICD group at 20 months (RR
  reduction 28 p0.016)

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Nanthakumar et al. JACC December 7, 20042166-72
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AMIOVIRTAmiodarone Versus Implantable
Cardioverter-Defibrillator Randomized Trial

• Patients with non-ischemic DCM (n101)
• Survival at 3 years 88 in the ICD group and 87
  in the control group (much higher than expected)

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The COMPANION StudyComparison of Medical
Therapy, Pacing, and Defibrillation in Patients
With LV Systolic Dysfunction

• Patients randomly assigned 122 ratio
• a.) Optimal medical therapy (OPT)
• b.) OPT plus cardiac resynchronization (CRT)
  pacemaker
• c.) OPT plus CRT pacemaker-defibrillator
• Primary end point a composite of death from any
  cause or hospitalization from any cause
  (randomization to time of 1st event)

Bristow, MR et al. N Engl J Med 20043502140-50.
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The COMPANION Study

• At 12 months, the mortality rate was 19 in the
  optimized medical therapy group, 15 in the CRT
  group, and 12 in the CRT-D group
• RR reduction in all cause mortality 24 with CRT
  (0.06) and 35 with CRT-D (p0.004).

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DEFINITEDefibrillators in Non-Ischemic
Cardiomyopathy Treatment Evaluation Trial

• Patients with non-ischemic DCM
• Mortality rate 13.8 with optimized medical
  therapy vs. 8.1 in patients randomized to ICD
  therapy over a mean follow-up period of 29 months
  (RR reduction 41 p0.06)

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DINAMITDefibrillator in Acute Myocardial
Infarction Trial

• Enrolled patients within 40 days of acute MI to
  optimized medical therapy either with or without
  an ICD
• No difference in all-cause mortality at a mean
  follow-up of 2.5 years (7.5 in the ICD goup vs.
  6.9 in the non-ICD group p0.66).

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SCD-HeFTSudden Cardiac Death in Heart Failure
Trial

• Randomized 2,521 patients with ischemic or
  non-ischemic DCM to optimized medical therapy
  with or without an ICD
• Median follow-up of 4 years
• Mortality rate 22 in ICD group, 28 in the
  amiodarone group, and 29 in the control group
  (24 RR reduction, p0.007)

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All Cause MortalityPooled Analysis of ICD
Primary Prevention Trials
7.9 absolute mortality reduction ( needed to
treat 13)
Nanthakumar et al. JACC December 7, 20042166-72
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Heart Rhythm Society Response(NASPE)

• Challenges imposed by registry (grace period)
• LVEF cutoff should be lt 35
• Interval for non-ischemic DCM implant gt3 months
  on appropriate medical Rx
• Coverage for CRT-D be extended to patients with
  class IV heart failure
• Coverage for patients if they already met the
  criteria for an ICD prior to their most recent
  MI, CABG, or PTCA
• Elimination of the term shock only

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Recommendations for ICD RxACC/AHA/NASPE 2002
Guideline Update

• Class I
• 1. Cardiac arrest due to VF or VT not due to a
  transient or reversible cause
• 2. Spontaneous sustained VT in association with
  structural heart disease
• 3. Syncope of undetermined origin with clinically
  relevant, hemodynamically significant sustained
  VT/VF at EPS when drug therapy is ineffective,
  not tolerated, or not preferred
• 4. Non-sustained VT in patients with CAD, prior
  MI, LV dysfunction, and inducible VF or sustained
  VT at EPS not suppressed by IA drug
• 5. Spontaneous sustained VT in patients without
  structural heart disease not amendable to other
  treatments

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Recommendations for ICD RxACC/AHA/NASPE 2002
Guideline Update

• Class IIA
• Patients with LVEF of less than or equal to 30
  at least 1 month post MI and 3 months post CABG

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Recommendations for ICD RxACC/AHA/NASPE 2002
Guideline Update

• Class IIB
• Cardiac arrest presumed due to VF when EP testing
  is precluded by other conditions
• Symptoms (eg, syncope) attributable to
  ventricular arrhythmias in patients awaiting
  cardiac transplantation
• 3. Familial or inherited conditions with a high
  risk of life-threatening ventricular
  tachyarrhythmias (eg, long QT, HCM)
• 4. Nonsustained VT with CAD, prior MI, and LV
  dysfunction, and inducible VT/VT at EPS

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Recommendations for ICD RxACC/AHA/NASPE 2002
Guideline Update

• Class IIB (continued)
• 5. Recurrent syncope of undetermined origin in
  the presence of ventricular dysfunction and
  inducible ventricular arrhythmias at EPS when
  other causes of syncope have been excluded
• 6. Syncope of unexplained origin or family
  history of unexplained SCD in association with
  typical or atypical RBBB and ST elevation
  (Brugada syndrome)
• 7. Syncope in patients with advanced structural
  heart disease in whom invasive and noninvasive
  investigations have failed to define a cause

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ICD ContraindicationsClass III

• Syncope of undetermined cause in a patient
  without inducible ventricular tachyarrhythmias
  and without structural heart disease.
• Incessant VT or VF
• VF or VT resulting from arrhythmias amendable to
  surgical or catheter ablation for example,
  atrial arrhythmias associated with W-P-W
  syndrome, RVOT VT, idiopathic LV tachycardia, or
  fascicular VT
• Ventricular arrhythmias due to a transient or
  reversible disorder (eg, AMI, electrolyte
  imbalance, drugs, or trauma) when correction of
  the disorder is considered feasible and likely to
  substantially reduce the risk of recurrent
  arrhythmia.

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ICD ContraindicationsClass III (continued)

• 5. Significant psychiatric illnesses that may be
  aggravated by device implantation or may preclude
  systematic follow-up
• 6. Terminal illnesses with projected life
  expectancy of less than 6 months
• 7. Patients with CAD with LV dysfunction and
  prolonged QRS duration in the absence of
  spontaneous or inducible sustained or
  nonsustained VT who are undergoing CABG
• 8. NYHA Class IV drug-refractory CHF in patients
  who are not candidates for cardiac transplant