Implantable Cardiac Devices
Data from published studies reveal that up to 21% of ICD patients receive inappropriate shocks.1-4
Detail - Incidence of inappropriate shocks in ICD patients
Reducing shocks has been shown to improve ICD patients’ quality of life and increased ICD acceptance.
Avoiding shocks is important for:
Kadish A, Dyer A, Daubert JP, et al., for the Defibrillators in Non-Ischemic Cardiomyopathy Treatment Evaluation (DEFINITE) Investigators. Prophylactic defibrillator implantation in patients with nonischemic dilated cardiomyopathy. N Engl J Med. 2004;350:2151-2158.
Daubert JP, Zareba W, Cannom DS, et al., for the MADIT II Investigators. Inappropriate implantable cardioverter-defibrillator shocks in MADIT-II: frequency, mechanisms, predictors, and survival impact. J Am Coll Cardiol. 2008;5:1357-1365.
Poole JE, Johnson GW, Hellkamp AS, et al. Prognostic importance of defibrillator shocks in patients with heart failure. N Engl J Med. September 4, 2008;359:1009-1017.
Mitka M. New study supports lifesaving benefits of implantable defibrillation devices. JAMA. 2009;302:134-135.
Sears SF JR, Todaro JF, Lewis TS, et al. Examining the psychosocial impact of implantable cardioverter defibrillators: a literature review. Clin Cardiol. 1999;22:481-489.
Sears SF Jr, Conti JB. Understanding implantable cardioverter defibrillator shocks and storms: medical and psychosocial considerations for research and clinical care. Clin Cardiol. 2003;26:107-111.
Irvine J, Dorian P, Baker B, et al. Quality of life in the Canadian Implantable Defibrillator Study (CIDS). Am Heart J. 2002;144:282-289.
Wathen MS, DeGroot PJ, Sweeney MO, et al, for the PainFREE RX II Investigators. Prospective randomized multicenter trial of empirical antitachycardia pacing versus shocks for spontaneous rapid ventricular tachycardia in patients with implantable cardioverter-defibrillators. Circulation. 2004;110:2591-2596.
Ahmad M, Bloomstein L, Roelke M, et al. Patients’ attitudes toward implantable defibrillator shocks. PACE. 2000;23:934-938.
Sweeney MO, Sherfesee L, DeGroot PJ, et al. Differences in effects of electrical therapy type for ventricular arrhythmias on mortality in implantable cardioverter-defibrillator patients. Heart Rhythm. 2010;7:353-360.
Medtronic developed its exclusive SmartShock Technology based on more than 20 years of experience in shock reduction. Consisting of six exclusive algorithms that discriminate true lethal arrhythmias from other arrhythmic and non-arrhythmic events, SmartShock Technology dramatically reduces the incidence of inappropriate shocks while maintaining sensitivity.1,2
Detail Fewer inappropriate shocks
With SmartShock Technology, 98% of ICD patients are free of inappropriate shocks at 1 year1 and 92% remain free of inappropriate shocks at 5 years.1
Detail Time to first in appropriate shock
Identifies T Wave oversensing and provides ability to withhold therapy delivery without compromising VT/VF detection sensitivity.
T Wave Discrimination algorithm
Combines two algorithms that detect, alert, and withhold inappropriate therapy for lead failure.
Provides advance warning for lead fracture and extends the VF detection time
Identifies oversensing due to noise artifacts and provides ability to withhold therapy
Lead Integrity Suite algorithm
Combines morphology and A-V pattern recognition to better discriminate against all types of SVTs – even the very fast ones.
Effectively discriminates sinus tachycardia and most atrial fibrillation/atrial flutter
Uses EGM morphology to improve SVT discrimination (i.e., conducted AF and sudden onset SVT)
PR Logic + Wavelet algorithm
Confirmation + algorithm
Volosin KJ, Exner DV, Wathen MS, Sherfesee L, Scinicariello A, Gillberg JM. Combining shock reduction strategies to enhance ICD therapy: A role for computer modeling. J Cardiovas Electrophysiol. Published online October 11, 2010.
Protecta Clinical Study, Medtronic data on file.
SmartShock 2.0 includes the following enhancements to improve long-term shock reduction, while simplifying device programming:
Changes in a patient’s disease and/or medications may alter the efficacy of a device’s programmed parameters or related features.
Reducing shocks by NID extension can benefit both primary and secondary prevention patients.1,2
According to data from the US CareLink® Network, more than 60% of devices are left at nominal settings of 18/24.4 The new nominal settings are designed to simplify clinician workflow and help reduce inappropriate shocks by allowing more rhythms to self-terminate.
Wilkoff BL, Williamson BD, Stern RS, et al. Strategic programming of detection and therapy parameters in implantable cardioverter-defibrillators reduces shocks in primary prevention patients: results from the PREPARE (Primary Prevention Parameters Evaluation) study. J Am Coll Cardiol. August 12, 2008;52(7):541-550.
Sweeney MO, Wathen MS, Volosin K, et al. Appropriate and inappropriate ventricular therapies, quality of life, and mortality among primary and secondary prevention implantable cardioverter defibrillator patients: results from the Pacing Fast VT REduces Shock ThErapies (PainFREE Rx II) trial. Circulation. June 7, 2005;111(22):2898-2905.
Gasparini M, et al. ADVANCE III: Longer detection window effective in reducing unnecessary ICD therapy. Late-Breaking Trial Session,LB01-4. Presented at the Heart Rhythm Society 33rd Annual Scientific Sessions, May 9-12, 2012, Boston, Mass.
Medtronic CareLink Database. July 2012.