Healthcare Professionals
Viva Quad S CRT-D
Cardiac Resynchronization Therapy Defibrillators (CRT-D)
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Healthcare Professionals
Cardiac Resynchronization Therapy Defibrillators (CRT-D)
Viva™ Quad S CRT-D device, paired with the Attain® Performa™ Quadripolar LV Lead, features 16 Programmable Vectors, the VectorExpress™ LV Automated Test, and Ensure CRT™ Suite with five integrated algorithms that automatically work together to ensure CRT delivery during challenging conditions.
Optimize CRT Response
While CRT is a highly effective therapy, there remains a need to improve the percentage of patients who receive full benefits. Studies have shown that up to one-third of patients do not experience all of the benefits of CRT.1-6
Many factors contribute to CRT non-response, including suboptimal AV timing, suboptimal LV lead placement, presence of arrhythmias, and reduced BiV pacing.7
As part of its comprehensive approach to treating heart failure patients with CRT, Medtronic offers a variety of solutions across every stage of care, including ways to optimize CRT response.
Potential Factors Contributing to Suboptimal CRT Response7
Detail - Suboptimal CRT Response
For CRT-D devices, certain programming and device operations may not provide cardiac resynchronization therapy. Changes in a patient's disease and/or indications may alter the efficacy of a device's programmed parameters or related features and may impact longevity.
Short Bipolar Spacing – Reduce phrenic nerve stimulation occurrence1-3
Steroid on All Electrodes – Improve thresholds and longevity4
Compatible With all Attain® Delivery Systems – Use preferred delivery tools including sub-selection catheters
Provides clinically actionable data on 16 vectors in 2 minutes5
Surgical complications, such as cardiac perforation, may occur and care must be taken when placing and positioning a cardiac lead. Please refer to the product labeling or Instructions For Use for complete safety Information, potential complications, Indications, Contraindications, Warnings and Precautions.
Attain Performa MRI SureScan Model 4298 (pdf)
Biffi M, et al. Utilizing Short Spacing between Quadripolar LV lead Electrodes to Avoid PNS. Cardiostim 2014, Poster presentation, Session 56P.
Biffi M, Foerster L, Eastman W, et al. Effect of bipolar electrode spacing on phrenic nerve stimulation and left ventricular pacing thresholds: an acute canine study. Circ Arrhythm Electrophysiol. August 1, 2012;5(4):815-820.
Biffi M, Zanon F, Bertaglia E, et al. Short-spaced dipole for managing phrenic nerve stimulation in patients with CRT: the “phrenic nerve mapping and stimulation EP” catheter study. Heart Rhythm. January 2013;10(1):39-45.
Lunati MG, Gasparini M, Landolina M, et al. Long-Term Effect of Steroid Elution on the Electrical Performance of Coronary Sinus Leads for Cardiac Resynchronization Therapy. Presented at HRS 2012 (AB10-05).
Demmer W. VectorExpress Performance Results. Medtronic Data on File, January 2013.
The Ensure CRT™ Suite, available in the Medtronic Viva™ Quad S CRT-D device, is designed to address conditions that can interrupt CRT response:1-7
The Ensure CRT Suite incorporates five integrated algorithms that automatically work together during these challenging conditions to ensure CRT delivery.11
Five Algorithms Address Challenging Conditions
Detail - Ensure CRT Graph
Learn more about the Ensure CRT Suite.
For CRT-D devices, certain programming and device operations may not provide cardiac resynchronization therapy. Changes in a patient's disease and/or medications may alter the efficacy of a device's programmed parameters or related features and may impact longevity.
Lemke B, Birnie D, Aonuma K. Comparison of cardiac resynchronization therapy optimization methods with respect to biventricular pacing percentage: sub-analysis of adaptive CRT trial. J Card Fail. 2012;18:S53-S54.
Aktas MK, Jeevanantham V, Sherazi S. Effect of biventricular pacing during a ventricular sensed event. Am J Cardiol. June 15, 2009;103(12):1741-1745.
Tse HF, Newman D, Ellenbogen KA, et al., for the AF SYMPTOMS study investigators. Effects of ventricular rate regularization pacing on quality of life and symptoms in patients with atrial fibrillation (AF symptoms mediated by pacing to mean rates [AF SYMPTOMS study]). Am J Cardiol. October 1, 2004;94(7):938-941.
Newman D, Lau CP, Tse HF, et al, for the AF SYMPTOMS study investigators. Clinical impact of rate regularization in patients with paroxysmal atrial fibrillation.Pacing Clin Electrophysiol. April 2003;26(4, Part II):1036.
Murgatroyd FD, Helmling E, Lemke B, et al. Manual vs. automatic capture management in implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators. Europace. June 2010;12(6):811-816.
Crossley GH, Mead H, Kleckner K, et al. Automated left ventricular capture management. Pacing Clin Electrophysiol. October 2007;30(10):1190-1200.
Burri H, Gerritse B, Davenport L, et al., on behalf of the Concerto AT Clinical Study Investigators. Fluctuation of left ventricular thresholds and required safety margin for left ventricular pacing with cardiac resynchronization therapy. Europace. July 2009;11(7):931-936.
Mullens W, Grimm RA, Verga T, et al. Insights from a cardiac resynchronization optimization clinic as part of a heart failure disease management program. JACC. 2009;53(9):765-773.
Knight BP, Desai A, Coman J, et al. Long-term retention of cardiac resynchronization therapy. J Am Coll Cardiol. 2004; 44(1):72-77.
Crossley GH, Mead H, Kleckner K, et al. Automated left ventricular capture management. Pacing Clin Electrophysiol. 2007;30(10):1190-1200.
Medtronic Viva/Viva Quad, Brava/Brava Quad CRT-D Reference Manual, Medtronic, Inc., Minneapolis, MN, USA.
The new PhysioCurve™ design for the Medtronic Viva™ Quad S CRT-D devices features a physiologic contoured shape for enhanced patient comfort.1
The Viva Quad S CRT-D maintains 35J output for ALL shocks.2
As compared to Protecta XT CRT-D. Assumptions for Quad S CRT-D: 600 ohm lead impedance, pre-arrhythmia EGM storage ON for 6 months; RA/RV Pacing % = 15%/100%; RA/RV Pacing Amplitudes: 2.5 V/2.5 V; LV Pacing Amplitude: 3.0 V; LV Pacing 100%; For more information, see the Viva Quad S CRT-D manual.
The PhysioCurve Design
Using a proprietary comparative shape pressure analysis, the contoured shape of PhysioCurve (Viva Quad S CRT-D IS4/DF4) resulted in a 30% reduction in skin pressure compared to non-contoured devices (CRT-D IS4/DF4). (Red areas indicate high skin pressure.)1
Detail – Pressure Analysis
For CRT-D devices, certain programming and device operations may not provide cardiac resynchronization. Changes in a patient's disease and/or medications may alter the efficacy of a device's programmed parameters.
Flo, Daniel. CRT-D IS4/DF4 Device Shape Analysis. April 2012. Medtronic data on file.
Medtronic Quad S CRT-D Technical Manual.
Introduced with Medtronic’s previous generation of CRT-D devices, SmartShock® Technology includes six exclusive algorithms that discriminate true lethal arrhythmias from other arrhythmic and nonarrhythmic events. SmartShock Technology dramatically reduces the incidence of inappropriate shocks while maintaining sensitivity.1,2
Detail – SmartShock Chart
SmartShock Technology has been enhanced to improve long-term shock reduction, while simplifying device programming. SmartShock 2.0 includes the following3:
For CRT-D devices, certain programming and device operations may not provide cardiac resynchronization. Changes in a patient's disease and/or medications may alter the efficacy of a device's programmed parameters.
Volosin, KJ, Exner DV, Wathen MS, et al. Combining shock reduction strategies to enhance ICD therapy: A role for computer modeling. J Cardiovasc Electrophysiol. March 2011;22(3):280-289.
To Schloss EJ, Auriccho A, Kurtia T, et al. PainFree SST Trial Primary Results: Low shock rates in patients with dual and triple Chamber ICDs using a novel detection algorithms. Heart Rhythm. 2013;10 (5):S64.
Medtronic Viva Quad S CRT-D manuals.
OptiVol® Fluid Status Monitoring tracks intrathoracic impedance changes over time to help clinicians assess congestion in patients with heart failure.*1,2 Heart Failure device diagnostics, with multiple parameters including OptiVol, are proven to identify patients at high risk for heart failure hospitalization.3-5
OptiVol 2.0 enhancements include6:
Reduced Unexplained Detections6
Detail - Unexplained Detections
For CRT-D devices, certain programming and device operations may not provide cardiac resynchronization. Changes in a patient's disease and/or medications may alter the efficacy of a device's programmed parameters.
Yu CM, Wang L, Chau E, et al. Intrathoracic impedance monitoring in patients with heart failure: correlation with fluid status and feasibility of early warning preceding hospitalization. Circulation. August 9, 2005;112(6):841-848.
Abraham WT, Compton S, Haas G, et al. 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. November 2009;15(9):813.
Small RS, Whellan DJ, Boyle A, et al. Implantable device diagnostics on the day of discharge from a heart failure hospitalization can predict 30 day readmission risk. J Card Fail. August 2012;18(8 Suppl):S50.
Whellan DJ, Ousdigian KT, Al-Khatib SM, et al. 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. April 27, 2010;55(17):1803-1810.
Whellan DJ, Sarkar S, Koehler J, et al. Development of a method to risk stratify patients with heart failure for 30-day readmission using implantable device diagnostics.Am J Cardio. January 1, 2013;111(1):79-84.
Sarkar S, Hettrick DA, Koehler J, et al. Improved algorithm to detect fluid accumulation via intrathoracic impedance monitoring in heart failure patients with implantable devices. J Card Fail. 2011;17(7):569-576.
Viva™ Quad S CRT-D Specifications1
IS4/DF4 (Model DTBB1QQ) | |
---|---|
Volume * |
35 cm3 |
Mass |
81 gr |
H x W x D | 74 mm x 51 mm x 13 mm (IS4/DF4) |
IS4/DF1 (Model DTBB1Q1) | |
---|---|
Volume * | 36 cm3 |
Mass |
82 gr |
H x W x D | 74 mm x 51 mm x 13 mm (IS4/DF1) |
*Volume with connector holes unplugged
See the appropriate Medtronic Manual for more information.
Medtronic Viva Quad S CRT-D device manuals.
IMPORTANT INFORMATION ON INDICATIONS, SAFETY AND WARNINGS
For listing of Indications, Contraindications, Warnings, Precautions, and Potential Adverse Events, please refer to the Instructions For Use .
Abraham WT, Fisher WG, Smith AL, et al. Cardiac resynchronization in chronic heart failure. N Engl J Med. June 13, 2002;346(24):1845-1853.
Young JB, Abraham WT, Smith AL, et al. Combined cardiac resynchronization and implantable cardioversion defibrillation in advanced chronic heart failure: the MIRACLE ICD Trial. JAMA. May 28, 2003;289(20):2685-2694.
Abraham WT, Young JB, León AR, et al. Effects of cardiac resynchronization on disease progression in patients with left ventricular systolic dysfunction, an indication for an implantable cardioverter-defibrillator, and mildly symptomatic chronic heart failure. Circulation. November 2, 2004;110(18):2864-2868.
Abraham WT, Leon AR, Hannon C, et al. Results of the InSync III Marquis clinical trial. Heart Rhythm. May 2005;2(5):S65.
Chung ES, Leon AR, Tavazzi L, et al. Results of the predictors of response to CRT (PROSPECT) trial. Circulation. May 20, 2008;117(20):2608-2616.
Abraham WT, et al. Results from the FREEDOM Trial – Assess the Safety and Efficacy of Frequent Optimization of Cardiac Resynchronization Therapy. Late-Breaking Clinical Trials. SP08. Presented at the Heart Rhythm Society 31st Annual Scientific Sessions, May 2010, Denver, Colorado.
Mullens W, Grimm RA, Verga T, et al. Insights from a cardiac resynchronization optimization clinic as part of a heart failure disease management program. JACC. 2009; 53(9):765-773.