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guidelines on aicd implantation for primary prophylaxis of sudden cardiac death implications of the new cms guidelines

New CMS Guidelines (Time Table). Draft of new guidelines released September 30th, 2004One month period allowed for public review and commentFinal ruling to be issued 60 days from October 28th, 2004. CMS Projections. Anticipated increase in number of eligible Medicare beneficiaries by 1/3 to 500,000CMS predicts 25,000 new implants next yearPrimary prevention guidelines (apply only to single-chamber devices) .

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guidelines on aicd implantation for primary prophylaxis of sudden cardiac death implications of the new cms guidelines

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    1. Guidelines on AICD Implantation for Primary Prophylaxis of Sudden Cardiac Death Implications of the New CMS Guidelines John D. Symanski, MD, FACC

    3. 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)

    4. “New” CMS Guidelines ICD for Primary Prevention ICD is reasonable and necessary for patients with ischemic DCM, documented prior MI, and LVEF < 30% Indicated for patients with non-ischemic DCM of greater than nine months duration and measured LVEF < 30% A provider implanting any ICD other than a single lead, shock only device for primary prevention must document medical necessity

    5. “New” CMS Guidelines Contraindications 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 < one year

    6. CMS Guidelines ICD 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

    7. Primary Prevention Trials ICD Therapy in Patients with LV Systolic Dysfunction Early Trials MADIT CABG-Patch MUSST CAT MADIT II Recent Studies AMIOVIRT COMPANION DEFINITE DINAMIT SCD-HeFT

    9. 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%, p=0.009)

    10. CABG-Patch Coronary 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 (p=0.64)

    11. MUSST Multi-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 (p=0.06) Non-randomized comparison of EP-guided patients receiving ICD had a 24% mortality at 5 years vs. 55% in those not receiving device

    12. MUSST Registry All-Cause Mortality in MADIT-II “Like’ Patients 65% over 5 years with QRS > 120 msec 46% over 5 years with QRS < 120 msec 38% (with ICD treatment) QRS > 120 msec 17% (with ICD treatment) QRS < 120 msec

    13. CAT Cardiomyopathy Trial Patients with non-ischemic DCM (n=104) 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 (p=0.554)

    14. MADIT II Mortality rate 19.8% in conventional treatment group and 14.2% in ICD group at 20 months (RR reduction 28%; p=0.016)

    16. AMIOVIRT Amiodarone Versus Implantable Cardioverter-Defibrillator Randomized Trial Patients with non-ischemic DCM (n=101) Survival at 3 years 88% in the ICD group and 87% in the control group (much higher than expected)

    17. Patients randomly assigned 1:2:2 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) The COMPANION Study Comparison of Medical Therapy, Pacing, and Defibrillation in Patients With LV Systolic Dysfunction

    18. 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 (p=0.004). The COMPANION Study

    19. DEFINITE Defibrillators 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%; p=0.06)

    20. DINAMIT Defibrillator 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; p=0.66).

    21. SCD-HeFT Sudden 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, p=0.007)

    22. All Cause Mortality Pooled Analysis of ICD Primary Prevention Trials

    23. Heart Rhythm Society Response (NASPE) Challenges imposed by registry (grace period) LVEF cutoff should be < 35% Interval for non-ischemic DCM implant >3 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”

    25. Recommendations for ICD Rx ACC/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

    26. Recommendations for ICD Rx ACC/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

    27. Recommendations for ICD Rx ACC/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

    28. 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 Recommendations for ICD Rx ACC/AHA/NASPE 2002 Guideline Update

    29. ICD Contraindications Class 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.

    30. ICD Contraindications Class 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

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