Protecta XT DR and VR
ICD Defibrillators
Protecta™ XT DR and VR ICDs with SmartShock Technology™ are designed to dramatically reduce the number of inappropriate shocks in patients being treated for tachycardia.
Importance of Shock Reduction
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
Important Safety Information
Changes in a patient’s disease and/or medications may alter the efficacy of a device’s programmed parameters or related features.
Reducing shocks has been shown to improve ICD patients’ quality of life and increased ICD acceptance.
- For patients, simply the fear of shocks can be disruptive to a normal, active life5,6
- The Canadian ICD Study (CIDS) found that patients randomized to ICD therapy (versus those given amiodarone) had better quality of life until they received five shocks7
- Some studies have demonstrated that experiencing just one shock causes temporary reductions in patients’ quality of life7
Avoiding shocks is important for:
- Reducing pain and anxiety, and increasing patients’ acceptance of ICDs8,9
- Reducing healthcare burden and improving patient quality of life8
- Improving survival/heart failure10
References
- 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.
SmartShock Technology
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
Important Safety Information
Changes in a patient's disease and/or medications may alter the efficacy of a device’s programmed parameters or related features.
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 inappropriate shock
Introducing SmartShock Technology
The story behind the development of SmartShock Technology
Detail SmartShock Techology algorithms
How SmartShock Technology Works
The six algorithms in SmartShock Technology address all major causes of inappropriate shocks1:
T Wave Discrimination
Identifies T Wave oversensing and provides ability to withhold therapy delivery without compromising VT/VF detection sensitivity.
- New approach to T Wave oversensing (TWOS)
- Frequency analysis versus manual sensitivity adjustment
- Fully automatic
- Does not require an initial shock for TWOS
- No compromise on VF detection sensitivity
T Wave Discrimination algorithm
Lead Integrity Suite
Combines two algorithms that detect, alert, and withhold inappropriate therapy for lead failure.
Lead Integrity Alert
Provides advance warning for lead fracture and extends the VF detection time
Lead Noise Discriminator + Alert
Identifies oversensing due to noise artifacts and provides ability to withhold therapy
- No compromise of VT/VF detection sensitivity
- Notifies clinician to potential lead noise
Lead Integrity Suite algorithm
PR Logic + Wavelet
Combines morphology and A-V pattern recognition to better discriminate against all types of SVTs – even the very fast ones.
PR Logic
Effectively discriminates sinus tachycardia and most atrial fibrillation/atrial flutter
+
Wavelet
Uses EGM morphology to improve SVT discrimination (i.e., conducted AF and sudden onset SVT)
Discrimination in the VF Zone (Nominal)
- SVT limit = 260 ms
- VF high-rate timeout
PR Logic + Wavelet algorithm
Confirmation +
- Better identifies that a tachycardia has been terminated with ATP or spontaneously during the charge and aborts the shock
- Avoids inappropriate shocks for single PVCs or single fast events at the end of the charge
Confirmation + algorithm
References
- 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.
Evidence Encyclopedia
Clinical evidence supporting the need for shock reduction and the performance of the Protecta portfolio of devices.
Clinical Need for Fluid Status Monitoring
Heart failure (HF) affects approximately 5.8 million Americans, and is the primary reason for over 1.1 million hospital admissions every year. The estimated direct and indirect cost of heart failure in the US for 2010 is $39.2 billion.1
- Approximately 50% of HF costs can be attributed to hospitalizations for acute decompensated HF.2
- Fluid volume overload (congestion) is a major complication for patients with moderate-to-severe HF and a frequent cause of hospital readmissions.3
- Fluid accumulation in HF patients is often detected too late to avert hospitalization.4
Important Safety Information
Changes in a patient’s disease and/or medications may alter the efficacy of a device’s programmed parameters or related features.
Detail - OptiVol Puzzle
Current Monitoring
- Assessing heart failure congestion is challenging.5
- Regular monitoring using body weight, blood pressure, and clinical symptoms does not always provide clarity and adequate time to prevent hospitalization.6-10
Patient Compliance Remains a Concern
- Nearly half of hospital readmissions for HF were caused by medication or dietary nonadherence.9
OptiVol Fluid Status Monitoring Does Not Rely on Patient Compliance
OptiVol monitoring, together with Cardiac Compass® Report, is a tool that objectively tracks fluid status and several other physiologic trends, without relying on patient compliance.
References
- American Heart Association. Heart Disease and Stroke Statistics – 2010 Update.
- American Heart Association. Heart Disease and Stroke Statistics – 2004 Update. Dallas, TX: American Heart Association. 2004.
- 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.
- Small RS. Integrating device-based monitoring into clinical practice: insights from a large heart failure clinic. Am J Cardiol. May 21, 2007;99(10A):17G-22G.
- Fonarow GC. How well are chronic heart failure patients being managed? Rev Cardiovasc Med. 2006;7(suppl 1):S3-11.
- Friedman MM. Older adults’ symptoms and their duration before hospitalization for heart failure. Heart Lung 1997;26:169 –176.
- Evangelista LS, Dracup K, Doering LV. Treatment-seeking delays in heart failure patients. J Heart Lung Transplant 2000;19:932–938.
- Stevenson LW, Perloff JK. The limited reliability of physical signs for estimating hemodynamics in chronic heart failure. JAMA 1989;261: 884–888.
- Vinson JM, Rich MW, Sperry JC, Shah AS, McNamera T. Early readmission of elderly patients with congestive heart failure. J Am Geriatr Soc 1990;38:1290 –1295.
- Abraham WT. Superior performance of intrathoracic impedance-derived fluid index versus daily weight monitoring in heart failure patients. Results of the Fluid Accumulation Status Trial. Late Breaking Clinical Trials. J Card Fail. Vol. 15 No. 9 2009, p 813. (FAST).
Protecta XT DR and VR ICD Defibrillators
Protecta XT DR ICD Defibrillators
7.7 seconds BOS*
9.2 seconds RRT**
37 cc,*** 68 g
Protecta XT VR ICD Defibrillators
7.7 seconds BOS*
9.4 seconds RRT**
37 cc,*** 68 g
See the Medtronic Protecta XT ICD Defibrillator Clinician Manual.
* Beginning of service
** Recommended Replacement Time
*** Volume with connector holes unplugged