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The Primary Prevention of Sudden Cardiac Death with ICD Therapy: Who Should Get a “Shock Box” ? Presentation Overview • Review of the clinical evidence supporting ICD therapy for primary prevention • Who are the patients? • What are the therapy requirements? • Is saving lives with ICDs cost effective? • Can the U.S. afford expanding device therapy to primary prevention patients? – A closer look at the size of the indicated populations – Putting it in perspective • Conclusions ICD Mortality Data in Context Primary Prevention ICD Clinical Studies Versus: 1. Secondary Prevention ICD Clinical Studies 2. Major Drug trials ICD Mortality Benefits in Primary Prevention Trials 75% 73% % Mortality Reduction w/ ICD Rx 61% 54% 55% 31% 1 2 3, 4 27 Months 39 Months 20 Months 1 Moss AJ. N Engl J Med. 1996;335:1933-40. 2 Buxton AE. N Engl J Med. 1999;341:1882-90. 3 Moss AF. N Engl J Med. 2002;346:877-83. 4 Moss AJ. Presented before ACC 51st Annual Scientific Sessions, Late Breaking Clinical Trials, March 19, 2002. Mortality Benefits with ICD Therapy 75% 76% % Mortality Reduction w/ ICD Rx 61% 54% 55% 31% ICD mortality reductions in primary 1 2 3, 4 prevention trials 27 months 39 months 20 months are equal to or greater than those in secondary prevention trials. % Mortality Reduction w/ ICD Rx 59% 56% 31% 33% 28% 20% 1 Moss AJ. N Engl J Med. 1996;335:1933-40. 2 Buxton AE. N Engl J Med. 1999;341:1882-90. 3 Moss AJ. N Engl J Med. 2002;346:877-83 6 4 5 7 Moss AJ. Presented before ACC 51st Annual Scientific Sessions, Late Breaking Clinical Trials, March 19, 2002. 3 Years 3 Years 3 Years 5 The AVID Investigators. N Engl J Med. 1997;337:1576-83. 6 Kuck K. Circ. 2000;102:748-54. 7 Connolly S. Circ. 2000:101:1297-1302. Primary Prevention ICD Trials: In Context with Other Landmark Trials 30 p=0.019 Non-active Rx 24.6 p=0.016 Active Rx Mortality (%) 20.4 19.8 15 14.2 p<0.01 p=NS 9.8 9.0 7.2 8.0 0 BHAT CASS SAVE MADIT II N=3800 N=780 N=2200 N=1200 HR=0.73 HR=0.89 HR=0.81 HR=0.69 Moss, AJ. MADIT II and its implications. European Heart Journal (2003); 24, 16-18. Who are the Patients? Who are the Primary Prevention Patients? Primary prevention patients have low LVEF and high percentages of Class II/III CHF. MADIT 1 MUSTT 3 MADIT II2 (n=196) (n=704) (n=1232) Age 63 68 64 LVEF 0.26 0.30 0.23 NYHA I 37% 37% 39% NYHA II or III 63% 63% 57% NYHA IV Excluded Excluded 4% CAD (%) 100 100 100 Previous CABG/PTCA (%) 73/27 56/23 60/45 1Moss A, et al. N Engl J Med. 1996;335:1933–40. 2Buxton, A, et al; N Engl J Med. 1999;341:1882–90. 3AVID Investigators; N Engl J Med. 1997;337:1576–83. 4Moss, A. et al; N Engl J Med. 2002;346:877–83. Who are the MADIT II Patients? AVID1 MADIT-II2 Study Completed 1997 2001 Study Population 1016 1232 3-year Mortality (ICD arm) 24.6%4 22%5 3-year Mortality (control arm) 35.9%4 31%5 Patient History •Age 65 64 •Male % 78% 84% MADIT II patients •NYHA Class II or III 36%3 59% had more severe •EF % 32% 23% structural heart disease than •History of Prior MI % 76% 100% AVID patients. AF at enrollment 21% 9% Patient Medical Management 1AVID investigators. N Engl. J Med. 1997; 337: 1576-1583. •Beta Blocker Use 39% 70% 2.Moss AJ. N Engl J Med. 2002; •ACE Inhibitor Use 68% 68% 346: 877-83. 3 Domanski MJ. Am J Cardiol. •Digoxin Use 44% 57% 1997; 80: 299-301. •Diuretics Use 4AVID @ 3 years f rom the KM curve: 57% 72% 36%-25%, NNT=9 N Engl J Med. •Amiodarone/Sotalol Use 12% 13% 1997;337:1576-1583 5MADIT-II @ 3 years f rom KM curve: •Class I AA Use 10% 3% 31%-22%, NNT=11 N Engl J Med. 2002;346:877-883 •Statin Use 23% 67% What Are the Therapy Requirements? What Are the Therapy Requirements? • Primary prevention patients will need > # of shocks as a secondary-prevention patient.1 – 40% of MADIT II study patients had a potential life-threatening VT/VF event terminated by their ICD within the first four years after implant. 2 • Ventricular fibrillation is the cause of SCA in only a small percentage of cases (< 10%). Ventricular tachycardia is the underlying etiology in >75% of SCA events. 3 1. Nisam S. “A Prophylactic ICD? Who are the patients? What is the device?” EUROPACE 2001; 3: 269-274 2. Moss AJ. J Cardiovasc Electrophysiol, Vol. 14, pp. S96-S98, September 2003, Suppl. 3. Bayés de Luna A. Am Heart J. 1989;117:151-159. What Are the Therapy Requirements? Device Longevity Requirements: • Same age and life expectancy as secondary prevention patient.1 • Patient survival is ~75% at 5 years. 2,3 Discrimination Technology Requirements: • AF/SVT even more an issue in MADIT II patients (more severe heart disease than AVID patients) 4,5 – 20-30% of ICD patients have atrial fibrillation at implant; 45% will have AF within 17 months post-implant 6,7 1. Nisam S. “A Prophylactic ICD? Who are the patients? What is the device?” EUROPACE 2001; 3: 269-274 2. Moss A, et al. N Engl J Med. 1996; 335: 1933-40. 3. Buxton A, et al. N Engl J Med. 1996; 341: 1882-90. 4. Moss AJ. N Engl J Med. 2002; 346: 877-83. 5. AVID investigators. N Engl. J Med. 1997; 337: 1576-1583. 6. Schmitt C, Montero M, Melicherick J. PACE 1994; 17: 295-302. 7. Medtronic GEM DR clinical data on f ile. What Are the Therapy Requirements? Conclusions: • The clinical profile and needs of the primary prevention patients are similar to the “classic” or secondary-prevention patients. • There is no single type of device that will meet the needs for the entire primary prevention population. How Do Devices Today Meet These Therapy Requirements? Reducing Shocks – ATP Programming ICD patients can be spared the majority (77%) of painful shocks if ATP is programmed as the first therapy for FVT1 Improved patient quality of life Shock therapy is painful and remains a barrier to patient acceptance of ICD therapy Reduction in potential hospitalizations associated with shocks Minimize “problem” calls to physician and staff Improved ICD longevity Each shock reduces battery life by ~ 24 days2 1 Wathen M, Sweeney M, DeGroot P. Circulation. 2001; 104: 796-801. 2 Marquis DR 7274 Reference Manual Reducing Shocks – Sophisticated Detection ICD patients can be spared the painful inappropriate shocks with advanced detection and SVT discrimination PR Logic clinically proven to reduce inappropriate shocks. - 100% Sensitivity, 92.8% PPV 1 Wavelet2 clinically proven to reduce inappropriate shocks. - 100% Sensitivity, 78% Specificity 2 1 Wilkoff, et al. Circulation, 2001; 103: 381-386. 2 Merrill, JJ etc al. NASPE Abstract, 2003 Therapy Success – Fast Charge Times Short and consistent charge times are important to minimize the risk of syncope and potential for DFTs to rise over time DFTs increase with VF duration1 Pre-shock syncope is a clinically relevant problem with ICD patients2 Limiting the time in VF to <10 seconds may reduce the risk of syncope3 1 Platia, et al;, Abstract, AHA 60 th Sessions #1235 2 Himmrich, et al; Abstract, Europace, Vol. 1, Suppl. D, July 2000, pg. 154 3 Windecker, et al; JACC.1999;33:33-38. Fewer Replacements – Optimal Longevity Younger patients will live with their implantable devices longer Patient survival is approximately 75% at 5 years1,2 Minimize replacement procedures Increase cost-effectiveness 1 Moss A, et al. N Engl J Med. 1996;335:1933–40. 2 Buxton A, et al. N Engl J Med 1999; 341:1882–90 Therapy Success – High Output We don’t know in advance which patients may have a problem at implant and which patients may have a problem with DFTs over time, 35J device provide a safety net for all. A patient’s clinical status is always changing. DFTs rise over time in specific patients.1-4 Both acute and chronic conditions may affect DFT values.5-20 * Ref erences in slide notes. Device Monitoring – Patient Alert Patient Alert self-monitoring of lead impedance, battery voltage, charge times, therapies delivered, and therapy success. Simple notification of device parameters that might require attention. Minimize potential for adverse outcomes. Patient peace of mind that device is operational. Patient Monitoring – Cardiac Compass ICD diagnostics should provide clinically relevant information to assist with patient and device management Provides trended diagnostic data to help you assess your patient's responses to therapeutic choices. Provides a chronological picture of patient response to validate that current medical treatments are working. Allows for drug, diet, and programming optimization. Current Lifeboat - Biotronik Airbag Positioning: Prophylactic ICD for those patients who have not demonstrated a need for advanced features. Size (cc) 39cc VF zone Yes Mass 78g Max shocks ~30 Output 30J Number VF 3 episodes before ERI Longevity 5 years VT Zone Yes – Monitor Only Warranty 5 years ATP for VT No Upgrade $5000 (0-24mo) VT/SVT Fixed Stability $2500 (25-60mo) discrimination http://www.biotronikusa.com/tachy/cardair/index.cfm Do Physicians really want Airbag? • Limited number of shocks – Risk of electrical storms 1 • No PainFREE therapies (no ATP) – 77% reduction in shocks for fast VT episodes 2 • Basic SVT discrimination – Risk of inappropriate device therapies 3-8 • Limited Diagnostics – Adequately manage advanced HF patients? • Upgrade to a full-featured device once the patient receives a shock – Cost efficient? Low Cost vs Patient Considerations • Optimize outcome for primary prevention patients: – Fast, effective SCA protection to reduce mortality • 35J available • Fast charge time – Patient and device monitoring to better manage patients and reduce potential hospitalizations • Cardiac Compass • Patient Alert – Minimal replacement procedures • Longevity – Minimal Shocks for patient acceptance and quality of life • Painless ATP therapy for FVT • Sophisticated Detection Algorithms • Do not sub-optimize your patient’s treatment! Is Saving Lives with ICDs Cost Effective? Cost-Effectiveness Analysis 1 Compare total cost of therapy with its benefit or effectiveness Average Cost-Effectiveness: total cost of therapy divided by years of life lived after receiving therapy: cost per life year ($/LY) Incremental Cost-Effectiveness: compare differences in total therapy cost and effectiveness between two competing therapies: cost per life year saved ($/LYS) 1 European Heart Journal (2000) 21, 712-719. Incremental Cost Effectiveness Analysis Therapy A versus Therapy B Total Cost A – Total Cost B Life Expectancy A – Life Expectancy B = Cost Per Life Year Saved ($/LYS) 1 European Heart Journal (2000) 21, 712-719. Incremental Cost-Effectiveness Results Cost Per Life Year Saved ($LYS): Effectiveness $0 or Less Cost Saving $1 - $20,000 Highly Cost-Effective $20,001- $40,000 Cost-Effective $40,001 - $60,000 Borderline Cost-Effective $60,001 - $100,000 Expensive > $100,000 Unattractive Source: Goldman. Cir 85. 1992 Incremental Cost-Effectiveness of ICD Therapy and Other Cardiovascular Interventions Incremental Cost per Life-Year Saved Economically Unattractive Expensive Borderline Cost-effective Cost-Effective Highly Cost-Effective CABG Primary Hypertension Cardiac PTCA Lovastatin (Chronic CAD, coronary (Chronic (chol. = 290 mg/dL, therapy Transplant CAD, mild mild angina, 50 yrs old, stenting (Diastolic (CHF, angina, 3 VD) male, no risk (CAD, 95-104 transplant 1 VD) factors) Angina, 1 VD, candidate) ICD- mmHg) ICD- Male, age 55) ICD- MADIT MADIT II* AVID estimate *Moss AJ. Presentation at Satellite Symposium, “Cost-Ef f ectiveness of Device Therapy in the Heart Failure Population”, Heart Failure Society of America Annual Meeting September 23, 2003. Number Needed to Treat To Save A Life NNTx years = 100 / (% Mortality in Control Group – % Mortality in Treatment Group) Drug Therapy amiodarone ICD Therapy simvastatin Metoprolol succinate captopril (5 Yr) (2.4 Yr) (3 Yr) (3 Yr) (3.5 Yr) (1 Yr) (6 Yr) (2 Yr) Cost Effectiveness Considerations: A Device IS NOT a Drug Device/Drug Distinctions (Chronic Disease) Device Drug (Oral) • Direct mechanism of action • Indirect mechanism of – Readily apparent response action – Metabolites, liver inactivation • Site/organ-specific therapy • Systemic treatment • Uniform patient response to • Variable patient response treatment – Dosing – Side-effects • High initial cost • Costs spread over treatment • Automatic therapy • Requires patient compliance • Cost-effectiveness remains • Successive generations relatively constant generally improve cost- effectiveness Intrinsic and Extrinsic Factors Affect Therapeutic Device Cost-Effectiveness Device-Intrinsic Extrinsic Factors • Achieved performance life • Implantation procedure – Battery longevity – Reliability – Learning curve – Durability – Implantation facility • Size – Length of stay • Electronic sophistication • Indications for use – Functionality • Patient selection – Software/algorithms – Co-morbidities • Complications • Deployment requirements • Complications • Follow-up requirements Intrinsic and extrinsic device advances progressively increase cost-effectiveness Representative Device Cost-Effectiveness Trends 1st generation Increasing Cost Effectiveness Financial Metric Nth generation Time, yrs. Case Example: Advances in Leads/electrodes and Pacemaker Current Drain (Composite effect of improved lead/electrode efficiency, stimulation patterns, increased understanding of stimulation physiology, and physician practice) Increasing Cost Effectiveness Energy Consumption Per Pacing Stimulus (µJ) Major increase in functionality 1970 1975 1980 1985 1990 1995 Adapted f rom Ohm, Pace, Vol 20 1997 Intrinsic Example: Implantable Defibrillator (ICD) Influence of ICD technology advance on cost-effectiveness: Power Source Longevity $/LYS (000) Cost-Effectiveness Power Source Longevity Mushlin AI, et al. Circulation. 1998; 97: 2129-2135. Extrinsic Example Influence of ICD patient selection criteria on cost-effectiveness: Pre-implant Ejection Fraction $/LYS (000) Cost -Effectiveness Ejection Fraction Kupersmith J, et al. Am H J 1995; 130: 507-15. Failure to consider therapy duration can incorrectly color cost-effectiveness findings $/LYS The AVID1 Trial concluded implantable cardioverter- defibrillator therapy reduces mortality compared with antiarrhythmic drugs in defined populations. However, by confining its length of follow-up to only 1.5 years, rather than patient life-expectancy or device longevity, cost/LYS was found to be in the “very expensive” range. MADIT reached a different conclusion. 1. Antiarrhythmics Versus Implantable Def ibrillator (AVID) MADIT 2 AVID1 2. Multicenter Automatic Def ibrillator Implantation Trial (MADIT) > 4 yr battery 1980: Large Devices, Limited Battery Life, Abdominal Implant, Epicardial Leads • First human implants • Thoracotomy, multiple incisions • Primary implanter= cardiac surgeon • General anesthesia • Long hospital stays • Complications from major surgery • Perioperative mortality up to 9% • Nonprogrammable therapy • High-energy shock only • Device longevity 1.5 years • Fewer than 1,000 implants/year Today Small devices - Pectoral site • First-line therapy for VT/VF patients • Treatment of atrial arrhythmias • Cardiac resynchronization therapy for Heart Failure • Transvenous, single incision • Local anesthesia; conscious sedation • Short hospital stays and few complications • Perioperative mortality < 1% • Programmable therapy options • Single- or dual-chamber therapy • Battery longevity up to 9 years • More than 100,000 world-wide implants/year *Battery longevity inf ormation in slide notes. Cost of ICD Therapy Down by 85% Since 1990 The cost/day of ICD therapy has dropped dramatically due to reduced procedure costs, reduced LOS (less invasive implant procedure due to pectoral implants/endocardial leads, ) and increased battery life. Major increase in functionality Increasing Cost Effectiveness Calculations and references in slide notes. Can the U.S. Afford The Primary Prevention of SCA with ICD Therapy? Can the US afford Expanding Indications For ICD therapy? PERCEPTION: REALITY: • Sudden cardiac arrest is not a • SCA is the #1 cause of death in the major problem. U.S. • ICDs are a last resort for patients • Clinical evidence supports ICD as who survive a sudden cardiac first-line therapy for prevention of arrest. SCA. • Millions of patients meet MADIT II • Only a small fraction of post-MI criteria. survivors qualify for an ICD under MADIT II criteria (approximately 280,000). • ICDs are being over-utilized. • Very few indicated patients are actually receiving therapy today. • The current health care system • The current health care system can cannot support treating all these afford to treat these patients. patients. A Closer Look at the Indicated Populations … Millions of Primary Prevention Patients? Analysis of Gross Prevalence Groups Diagrams not to scale References in Slide ―Notes‖ Post- MI1 ~ 7,500k EF<40%2 ~1,350k EF<30%= 405k 3-9 (MADIT II) EF<35%, NSVT, EF<40%, NSVT, EF<40%, NSVT= inducible, non Inducible VT/VF= 400k10 suppressible12 140k11 (MUSTT Registry) (MADIT) (MUSTT) Portion of MUSTT Not Part of MADIT II = 95k Millions of Primary Prevention Patients? Analysis of Prevalence Groups MADIT II MUSTT 3 Total High- Risk Post-MI Gross 405,000 95,000 500,000 Prevalence Exclusions 125,000 1,2 25,000 1,2 150,000 1,2 (clinical and economic) Net 280,000 70,000 350,000 Prevalence The incidence (annual new cases) of total high-risk post-MI patients is estimated to be 70,000.* 1. 15% of the U.S. Population does not have access to healthcare. Health Insurance Coverage in the United States; 2002; U.S. Census Bureau, Current Population Survey, 2002 and 2003 Annual Social and Economic Supplements. 2. Of the remaining 85% who have access to health coverage, approximately 20% would not be considered f or ICD therapy due to cli nical exclusions (e.g., comorbidities, age, patient ref usal, etc.) Source: physician interviews. 3. Not overlapping with MADIT II. * Calculations in slide notes. Number of Potential ICD Therapy Candidates in the US Indication/ Estimated Estimated % Patient Groups Net Prevalence Penetration of Net Prevalence Class I (AVID, MADIT, MUSTT) 390,000 ~34% 1 Class IIa (MADIT II) 280,000 <10% 2 Total 670,000 ~20%* 1 Ruskin, N. J Cardiovascular Electrophysiologic, 2002;13:38-43. 2 Medtronic internal estimate. * Weighted average of Class I and Class IIa penetration estimates. Putting it in Perspective… Magnitude of SCA in the US 167,366 SCA claims Stroke3 more lives each year than these 450,000 other Lung diseases SCA 4 Cancer2 157,400 combined Breast Cancer2 40,600 #1 Killer AIDS1 42,156 in the U.S. 1 U.S. Census Bureau, Statistical Abstract of the United States: 2001. 2 American Cancer Society, Inc., Surveillance Research, Cancer Facts and Figures 2001. 3 2002 Heart and Stroke Statistical Update, American Heart Association. 4 Circulation. 2001;104:2158-2163. Direct Medical Expenditures on Diseases with High Mortality (2001 $US) Despite the higher number of SCD deaths, spending is lower than for diseases with fewer annual deaths. 1, 2 3 3 4 4 1 Bozzette et al., 1998 2 http://www.cdc.gov/hiv/stats.htm: Accessed 2/04/2003 3 http://www.cancer.org/docroot/mit/content/mit_3_2x_costs_of_cancer.asp: Accessed 12/07/2002 4 Healthcare Financing Review, Medicare and Medicaid Statistical Supplement, 2000 2001 US Expenditures 1,2 Selected CV Drugs and ICD Therapy Billion $ Billions/Yearly Billion Billion Billion 1 Medtronic ICD industry sales analysis. 2 IMS America 2001 Pharmaceutical sales figures. Comparison of Healthcare Costs 10.0 8.97 9.04 9.0 8.35 8.0 Annual Cost in Billions 7.0 6.0 5.0 4.0 3.0 2.30 2.0 1.0 0.0 ICD* PTCA† CABG+ Statins‡ *Medtronic estimations (total number of implants x $30,000) †Morgan Stanley Dean Witter Research Report, 2001 / CMS reimbursement data. +AHA 2002 / Cowper, et al; American Heart Journal. 143:(1):130–9. Comparison of Healthcare Costs 350.0 294 300.0 $11.6 B—estimated amount due to Annual Cost in Billions 250.0 miscoding, insufficient Healthcare documentation, etc. in Administration1 200.0 Medicare (HCFA 2000 Financial Report) 150.0 100 100.0 50.0 30 2 8 9 9 0.0 ICD* PTCA† CABG+ Statins‡ Economic impact Lost dollars from of over- health care fraud, prescribing abuse and waste^^ *Medtronic estimations (total number of implants x $30,000). †Morgan Stanley Dean Witter Research Report, 2001 / CMS reimbursement data. antibiotics^ +AHA 2002 / Cowper, et al; American Heart Journal. 143;(1):130–9. ‡ Pharmacy Times, “Top 200 drugs of 2000”; 2001. ^ National Institute of Health, Antimicrobial Resistance, NIAID Fact Sheet. ^^ U.S. General Accounting Office 2001. 1 Woolhandler S, et al. Costs of Healthcare Administration in the United States and Canada. N Engl J Med 344, 2003; 349: 768-75. 2000 US Total Health Expenditures: $1.3 Trillion1 ICD Therapy $2.2 Billion • $2.2 Billion spent on ICD Therapy2 - 0.17% of total US healthcare expenditures • If ICD implants double, total ICD costs will remain a fraction of US healthcare costs 1 www.cms.hhs.gov/statistics/nhe/historical/t2.asp 2 ICD industry sales, implant, and follow-up cost analysis. Medtronic data on file. Societal Spending on Other Life-Saving Interventions 1 Cost/Life-Year Intervention Saved in 1993 Flashing lights at railroad crossings $42,000 Flammability standard for upholstered furniture $68,000 Airbags (vs. manual lap belts) in cars $120,000 Annual mammography for women age 40-49 $190,000 Smoke detectors in homes $210,000 Front disk (vs. drum) brakes in cars $240,000 Strengthen buildings in earthquake-prone areas $18,000,000 Ground fault circuit interrupters $1,200,000 1. Tengs TO, et al. Five-Hundred Lif e-Saving Interventions and Their Cost-Ef f ectivenss. Risk Analysis, Vol. 15, No. 3, 1995. Conclusions Medical Device Cost-Effectiveness Conclusions • In practice, medical devices present sharp distinctions to other medical therapies. These distinctions must be considered when determining costs. • Cost-effectiveness studies conducted in the nascent period of device evolution are likely to present a worst-case scenario and can produce misleading conclusions. • High “front end” costs of implants require that economic analyses consider the life-time benefits of the therapy. • Cost-effectiveness metrics generally indicate medical devices compare favorably to other accepted treatments. Conclusions : The US Can Afford ICD Therapy • In the US, SCA is the #1 cause of death. • ICD therapy is an accepted first line therapy to prevent SCA. • Clinical evidence supports the benefit of ICD therapy for both primary and secondary prevention of SCA. • ICD therapy’s cost effectiveness is in line with other widely accepted cardiovascular therapies. • ICD therapy represents only a small fraction of US healthcare system expenditures. “Clinicians and health economists need to be aware that the cost efficacy analysis should be used to guide the development of sensible clinical practice but it can easily be corrupted to a tool for crude rationing. Purchasers of health care should remember that, historically, technological advance has been the solution, not the problem.” P. R. Roberts T. R. Betts J. M. Morgan Wessex Cardiothoracic Center Southampton General Hospital, Southampton, U.K. Eur Heart J, Vol. 21,issue 9, May 2000 DISCLOSURE Indications Medtronic implantable cardioverter defibrillators (ICDs) are indicated to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. Contraindications Medtronic ICDs are contraindicated in: Patients with transient or reversible ventricular tachyarrhythmia or as the sole treatment of atrial arrhythmia. Warnings/Precautions Changes in patient’s disease and/or medications may alter the efficacy of the device’s programmed parameters. Patients should stay away from sources of magnetic and electromagnetic radiation, including MRI, diathermy, and electrosurgical units, to avoid possible underdetection, inappropriate therapy delivery, and/or electrical reset of the device. Do not place transthoracic defibrillation paddles directly over the device. See the appropriate technical manuals for detailed information regarding instructions for use, indications, contraindications, warnings, precautions, and potential adverse events. Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
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