Aditya Vaidya BS Electrical Engineering M Eng Management IBHRE Certified ICD Therapy Presents Patient Identification, Clinical and Economic Challenges • Patients with Ventricular Tachycardia (VT)/Ventricular Fibrillation (VF) are at risk of sudden cardiac death (SCD) • ICD is the most successful therapy to prevent SCD1 • Many patients without symptoms die from SCD if not rescued timely • Some patients often face accessibility to care and economic challenges2,3 Constant Challenges Quality of Life Road Blocks http://www.hrsonline.org/PatientInfo/Treatments/ICD/icd_faqs.cfm Lyne J Inappropriate ICD shocks – challenges and advances Arrhythmiawatch Published online September 28, 2011 Boriani G, Biffi M, Martignani C, et al Expenditure and value for money: the challenge of implantable cardioverter defibrillators QJM May 2009;102(5):349-356 Challenges in Patient Selection: Access to Appropriate Diagnostic Tools SQDM – Product Evolution From Diagnosing to Monitoring Reveal 1998 Reveal Plus Reveal is developed to help diagnose unexplained syncope Automatic detection added 2000 Reveal DX 2007 Reveal XT 2009 Longevity and ECG memory increased (to yrs., 49.5 minutes), with episode logs, ICD sensing technology, MRI labeling, and remote monitoring added AF detection and long-term trended diagnostics (the Cardiac Compass and AF Summary Reports) added ScreenLink Medtronic ScreenLink is an evidence-based app designed to facilitate screening of patients qualifying for ICD and/or CRT therapies Sprint Quattro® Family of Defibrillation Leads The Standard for Exceptional Performance Sprint Quattro Secure® S Model 6935 Active Fixation, Single Coil Sprint Quattro Model 6944 Passive Fixation, Dual Coil Sprint Quattro Secure Model 6947 Active Fixation, Dual Coil Backed by the Most Comprehensive Performance Monitoring System in the Industry1 Sweeney MO, et al J Cardiovasc Electrophysiol 2001;12:402-410 Sprint Quattro Family of Leads Medtronic Product Performance Report, 2011 First Edition, Issue 64 St Jude Medical Product Performance Report, April 2011 Boston Scientific Product Performance Report 2011, Q3 Summary Edition Borleffs CJ, van Erven L, van Bommel RJ, et al Circ Arrhythm Electrophysiol 2009;2:411-416 The Standard for Performance1 Sprint Quattro Secure® 6947 lead shows a 96% lead survival rate at years when measured by this active monitoring1 6947 Sprint Quattro Secure DEVICE SURVIVAL PROBABILITY 100 90 80 yr yr yr yr yr yr yr yr yr % 99.5 99.2 98.9 98.6 98.1 97.7 97.2 96.7 96.0 # 2364 1675 963 733 579 425 280 152 53 Medtronic PPR 2012 2nd edition – 6947 Sprint Quattro Secure lead 10 Anti-Tachycardia Pacing Improves Quality of Life • A study concluded that shocked Ventricular Arrythmia (VA) episodes are associated with mortality risk Shocked patients have substantially higher VA episode burden and poorer survival compared with ATP-only-treated patients.1 • A quality of life meta-analysis study found that activation of antitachycardia pacing should be performed in every ICD patient in order to minimize painful shocks and consequent deterioration of quality of life2 Sweeney MO, et al Heart Rhythm 2010;7:353-360 Francis J, et al Indian Pacing Electrophysiol J 2006;1:173-181 SmartShock® 2.0 Evidence Reducing shocks for both primary and secondary patients is important1,2 • In Primary Prevention Patients – PREPARE showed a 63% reduction in shocks for patients programmed with strategically chosen programming, including a NID of 30/40, as compared to historical trials1 • In Secondary Prevention Patients – ADVANCE III showed a 37% reduction of shock and ATP therapies for patients programmed to 30/40 as compared to 18/24 with no difference in syncopal events3 Wilkoff BL, et al J Am Coll Cardiol 2008;52:541-550 Sweeney MO, et al Circulation 2005;111:2898-2905 Gasparini M, et al Late Breaking Trial Session 1-4, HRS 2012 Patient Selection Other Clinical Trials PR Logic® IRIS PainFREE RX ADVANCED PainFREE RX II WAVE 634 patients 1,122 patients EnTrust® EMPIRIC 898 patients Virtual ICD ADVANCE III Shock-less 900 patients PREPARE 700 patients RELEVANT 324 patients OMNI 560 patients 3,000 patients PainFREE SST Medtronic Exclusive Technology: SmartShock™ Technology Medtronic Pain Free™ Solutions MVP® Mode ATP During Charging™ OptiVol® Fluid Status Monitoring Conexus® Wireless Telemetry Medtronic CareLink® Network Medtronic CareAlert® Notifications Complete Capture Management™ Detailed EGM™ Viewer TherapyGuide™ Industry-Leading AT/AF Solutions Challenges in Patient Therapy: Longevity Studies Confirm that Medtronic Defibrillation Devices Last Longer1-5 Netherlands Experience1 US Experience4 Swiss Experience2 Italian Experience3 Kaplan-Meier curve for event-free survival of ICDs replaced because of battery depletion for the manufacturers Knops P, et al PACE 2009;32:1276-1285 Schaer BA, et al Heart Rhythm 2009;6:1737-1743 Biffi M, et al Europace 2008;10:1288-1295 Kallinen L, et al 2009 http://spo.escardio.org/eslides/view.aspx?eevtid=33&id=1913 Joep Thijssen, MD, et al Leiden University Medical Center, Leiden, The Netherlands Available online 15 November 2011;pg Challenges in Patient Care: Device Diagnostic Data OptiVol® Fluid Status Monitoring Volume overload is a major complication for patients with moderateto-severe HF and is a frequent cause of the “revolving door” of hospital admissions and discharges.1 OptiVol Fluid Status Monitoring provides unique insight into thoracic fluid buildup for more informed patient care.2 Combined diagnostics including OptiVol Fluid Status Monitoring identified patients at 5.5 times increased risk for HF hospitalization Sackner-Bernstein J What is heart failure and what are the treatment options? Complex questions In: Hayes DL, Wang PJ, Sackner-Bernstein J, Asirvatham SJ, eds Resynchronization and Defibrillation for Heart Failure: A Practical Approach Oxford, England: Blackwell Publishing; 2004:1-2 Medtronic Consulta®, Concerto®, and InSync Sentry® CRT-Ds and Secura® and Virtuoso® DR/VR ICDs System Reference Guides Whellan DJ, Ousdigian KT, AL-Khatib SM, et al, for the PARTNERS Study Investigators Combined heart failure device diagnostics identify patients at higher risk of subsequent heart failure hospitalizations: results from PARTNERS HF (Program to Access and Review Trending Information and Evaluate Correlation to Symptoms in Patients With Heart Failure) study J Am Coll Cardiol 2010; 55(17):1803-1810 Cardiac Compass® Trends and Heart Failure Management Report TherapyGuide® TherapyGuide – Tailored, Clinically-Oriented Programming Using Physician-Selected Parameters TherapyGuide simplifies and tailors programming by providing suggested device settings based on physician-selected patient conditions Patient information can be entered in the patient information screen prior to implant, and that data is automatically populated to TherapyGuide Explains parameter suggestions based on results of clinical studies and common best practices Provides parameter suggestions based on a patient’s condition and status Ask The ICD Select the right therapy for the patient Implant reliable leads with good defibrillation threshold Reduce inappropriate shocks Patient Alerts and Device Diagnostic Data Thank You The Medtronic Mission Alleviate pain, Restore health, and Extend life [...]... Medtronic CareLink® Network Medtronic CareAlert® Notifications Complete Capture Management™ Detailed EGM™ Viewer TherapyGuide™ Industry-Leading AT/AF Solutions Challenges in Patient Therapy: Longevity Studies Confirm that Medtronic Defibrillation Devices Last Longer1-5 Netherlands Experience1 US Experience4 Swiss Experience2 Italian Experience3 Kaplan-Meier curve for event-free survival of ICDs replaced because... technical details 1 Heintze J, Schloss E, Auricchio A, Zeng C, Sterns L No compromise in VT/VF detection with novel tachyarrhythmia discrimination features in implantable cardioverter defibrillators Wilkoff BL Current topics in ICD Primary Prevention December 28, 2006 3 Volosin KJ, et al J Cardiovasc Electrophysiol 2010;22:280-289 4 Poole JE, et al N Engl J Med 2008;359:1009-1017 2 Anti-Tachycardia... et al 2009 http://spo.escardio.org/eslides/view.aspx?eevtid=33&id=1913 2 5 Joep Thijssen, MD, et al Leiden University Medical Center, Leiden, The Netherlands Available online 15 November 2011;pg 5 Challenges in Patient Care: Device Diagnostic Data OptiVol® Fluid Status Monitoring Volume overload is a major complication for patients with moderateto-severe HF and is a frequent cause of the “revolving... PainFREE Rx II Investigators Circulation 2004;110:2591-2596 Sweeney MO, et al Differences in effects of electrical therapy type on health care utilization in the MVP ICD Trial HRS, 2010 With SmartShock Technology, 98% of Patients Are Free of Inappropriate Shocks at 1 Year1 1 Volosin KJ, et al J Cardiovasc Electrophysiol 2011;22:280-289 SmartShock™ Technology Includes Six Exclusive Algorithms that Discriminate... 1.5x safety factor for electrical isolation defined in ISO 27186 Medtronic data on file January 26, 2012 Himes, Adam “Worldwide Sales Memo 2012.” The new DF4 lead has over 58% reduction in lead connector volume Medtronic data on file January 26, 2012 3 Medtronic Product Performance Report, 2011 First Edition, Issue 64 2 • No complicated scanning restrictions • Full body scanning in any combination of... increase is due to1: • Increased battery capacity and reduced current drain • No capacitor formation required • Improved telemetry efficiency *As compared to Protecta XT DR 1 Medtronic Evera XT and Protecta XT Manuals Projected service life, in years Evera XT VR Why Avoiding Shocks is Important To Reduce Pain and Anxiety and Increase Device Acceptance1 1 2 To Reduce Healthcare Burden and Improve Patient Quality... shocks for patients programmed with strategically chosen programming, including a NID of 30/40, as compared to historical trials1 • In Secondary Prevention Patients – ADVANCE III showed a 37% reduction of shock and ATP therapies for patients programmed to 30/40 as compared to 18/24 with no difference in syncopal events3 1 2 3 Wilkoff BL, et al J Am Coll Cardiol 2008;52:541-550 Sweeney MO, et al Circulation... Am Coll Cardiol 2010; 55(17):1803-1810 Cardiac Compass® Trends and Heart Failure Management Report TherapyGuide® TherapyGuide – Tailored, Clinically-Oriented Programming Using Physician-Selected Parameters TherapyGuide simplifies and tailors programming by providing suggested device settings based on physician-selected patient conditions Patient information can be entered in the patient information... information can be entered in the patient information screen prior to implant, and that data is automatically populated to TherapyGuide Explains parameter suggestions based on results of clinical studies and common best practices Provides parameter suggestions based on a patient’s condition and status Ask The ICD Select the right therapy for the patient Implant reliable leads with good defibrillation threshold... informed patient care.2 Combined diagnostics including OptiVol Fluid Status Monitoring identified patients at 5.5 times increased risk for HF hospitalization 3 1 Sackner-Bernstein J What is heart failure and what are the treatment options? Complex questions In: Hayes DL, Wang PJ, Sackner-Bernstein J, Asirvatham SJ, eds Resynchronization and Defibrillation for Heart Failure: A Practical Approach Oxford,