Healthcare Professionals
Viva Quad XT CRT-D
Cardiac Resynchronization Therapy Defibrillators (CRT-D)
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Healthcare Professionals
Cardiac Resynchronization Therapy Defibrillators (CRT-D)
Viva™ Quad XT CRT-D device, paired with the Attain® Performa™ Quadripolar LV Lead, features 16 Programmable Vectors, the VectorExpress™ LV Automated Test, and the AdaptivCRT® algorithm, which improves CRT response rate* with minute-to-minute optimization of CRT pacing.
*Compared to echo-optimized CRT.
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.
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.
Available in select Medtronic CRT devices, the AdaptivCRT algorithm continuously and dynamically adapts CRT pacing method and AV/VV delays.1 By promoting intrinsic RV conduction, AdaptivCRT reduces RV pacing and increases device longevity for patients with normal AV conduction.1
Clinical evidence shows that AdaptivCRT improves patient outcomes, compared to echo-optimized CRT2-6 including:
Watch these videos to learn more about the AdaptivCRT algorithm.
AdaptivCRT Overview Video with Medtronic Scientists (3:19)
AdaptivCRT Algorithm Animation (3:10)
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.
References
Medtronic Viva/Viva Quad, Brava/Brava Quad CRT-D Manual, Medtronic, Inc., Minneapolis, MN, USA.
Martin DO, Lemke B, Birnie D, et al. Investigation of a novel algorithm for synchronized left- ventricular pacing and ambulatory optimization of cardiac resynchronization therapy. Heart Rhythm. November 2012; 9(11):1807-14.
Birnie D, Lemke B, Aonuma K, et al. Clinical outcomes with synchronized left ventricular pacing: analysis of the adaptive CRT trial. Heart Rhythm. September 2013; 10(9):1368-74.
Starling RC, Krum H, Bril S, et al. Impact of novel adaptive Optimization algorithms on 30-day readmissions: evidence from the Adaptive CRT Trial. HRS 2014 Poster Session.
Martin D, Lemke B, Aonuma K, et al. Clinical outcomes with adaptive cardiac resynchronization therapy: long-term outcomes of the Adaptive CRT Trial. HFSA Late Breakers. September 23, 2013.
Tarab AD, Dougher CE, Rogers TB, et al. Budget impact of selecting cardiac resynchronization therapy (CRT) devices with adaptive (“aCRT”) programming algorithms under the United States Medicare Payment Setting. Value in Health. November 2012; 15(7):A349.
The new PhysioCurve™ design for the Medtronic Viva™ Quad XT CRT-D devices features a physiologic contoured shape for enhanced patient comfort.1
The Viva Quad XT CRT-D also has one additional year of device longevity2* and maintains 35J output for ALL shocks.3
*As compared to Protecta XT CRT-D. Assumptions for Viva Quad XT CRT-D: 600 ohm lead impedance, pre-arrhythmia EGM storage ON for 6 months; RA/RV Pacing % = 15%/50%; RA/RV Pacing Amplitudes: 2.5 V/2.5 V; LV Pacing Amplitude: 3.0 V; LV Pacing 100%; AdaptivCRT programmed to Adaptive BiV and LV. For more information, see the Viva Quad XT CRT-D manual.
The PhysioCurve Design
Using a proprietary comparative shape pressure analysis, the contoured shape of PhysioCurve (Viva Quad XT 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.
Sawchuk R, Younker G. Comparison of Viva XT CRT-D and Protecta XT CRT-D Projected Service Life. Medtronic data on file. January 2013. Projected service life estimates are based on accelerated battery discharge data and device modeling as specified. Do not interpret these values as precise numbers.
Medtronic Viva Quad XT 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 following:3
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.
IS4/DF4 (Model DTBA1QQ) | |
---|---|
Volume * | 35 cm3 |
Mass | 81 gr |
H x W x D | 74 mm x 51 mm x 13 mm (IS4/DF4) |
IS4/DF1 (Model DTBA1Q1) | |
---|---|
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 XT CRT-D device manuals.
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.
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 .