Healthcare Professionals
VivaTM XT CRT-D
Cardiac Resynchronization Therapy Defibrillators (CRT-D)
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Healthcare Professionals
Cardiac Resynchronization Therapy Defibrillators (CRT-D)
Viva™ XT CRT-D devices feature the AdaptivCRT® algorithm, which improves CRT response rate* with minute-to-minute optimization of CRT pacing. CRT non-response is a significant unmet medical need affecting up to one-third of patients implanted with CRT devices.1-7 The new PhysioCurve™ contoured Viva XT CRT-D has increased device longevity8 and enhances patient comfort.9
*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.1-7
Many factors contribute to CRT non-response, including suboptimal AV timing, suboptimal LV lead placement, presence of arrhythmias, and reduced BiV pacing.8
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.
Percentage of Patients with Adequate CRT Response1-6
Detail - Adequate CRT Response
Potential Factors Contributing to Suboptimal CRT Response8
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 medications may alter the efficacy of a device's programmed parameters or related features and may impact longevity. Please refer to the Instructions For Use for complete safety Information, potential complications, Indications, Contraindications, Warnings and Precautions.
Available in select Medtronic CRT devices, the AdaptivCRT algorithm continuously and dynamically adapts CRT pacing method and AV/VV delays.10 By promoting intrinsic RV conduction, AdaptivCRT reduces RV pacing and increases device longevity for patients with normal AV conduction.10
AdaptivCRT Algorithm:
Minute-to-Minute Optimization of CRT
Detail - AdaptivCRT Algorithm
Clinical evidence shows that AdaptivCRT improves patient outcomes, compared to echo-optimized CRT,7,11-14 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 medications may alter the efficacy of a device's programmed parameters or related features and may impact longevity.
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.
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.
Sawchuk R, Younker G. Projected Service Life: ACRT Longevity Improvement over Protecta. 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.)
Flo, Daniel. CRT-D IS4/DF4 Device Shape Analysis. April 2012. Medtronic data on file.
Medtronic Viva XT CRT-D Clinician Manual, Medtronic, Inc., Minneapolis, MN, USA.
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™ XT CRT-D devices features a physiologic contoured shape for enhanced patient comfort.9
The Viva XT CRT-D also has one additional year of device longevity8* and maintains 35J output for ALL shocks.10
*As compared to Protecta XT CRT-D. Assumptions for Viva 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 XT manual.
The PhysioCurve Design
Detail – PhysioCurve Design
Using a proprietary comparative shape pressure analysis, the contoured shape of PhysioCurve (Viva XT CRT-D IS1/DF4) resulted in a 30% reduction in skin pressure compared to non-contoured devices (CRT-D IS1/DF4).9 (Red areas indicate high skin pressure.)
Detail – Pressure Analysis
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.
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: Results of the Adaptive CRT Trial. Heart Rhythm. November 2012;9(11):1807-1814.
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.
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, Leon AR, Hannon C, et al. Results of the InSync III Marquis clinical trial. Heart Rhythm. May 2005;2(5):S65.
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.
Sawchuk R, Younker G. Projected Service Life: ACRT Longevity Improvement over Protecta. 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.)
Flo, Daniel. CRT-D IS4/DF4 Device Shape Analysis. April 2012. Medtronic data on file.
Medtronic Viva 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.10,11
Detail – SmartShock Chart
SmartShock Technology has been enhanced to improve long-term shock reduction, while simplifying device programming. SmartShock 2.0 includes the following:
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.
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: Results of the Adaptive CRT Trial. Heart Rhythm. November 2012;9(11):1807-1814.
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.
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, Leon AR, Hannon C, et al. Results of the InSync III Marquis clinical trial. Heart Rhythm. May 2005;2(5):S65.
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.
Sawchuk R, Younker G. Projected Service Life: ACRT Longevity Improvement over Protecta. 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.)
Flo, Daniel. CRT-D IS4/DF4 Device Shape Analysis. April 2012. Medtronic data on file.
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.
Protecta Clinical Study, Medtronic data on file.
OptiVol 2.0 Fluid Status Monitoring
OptiVol Fluid Status Monitoring objectively tracks fluid status and other physiologic trends to help clinicians monitor complications,10,11 identify patients with long-term mortality risk,12 and potentially avoid hospital readmissions for their heart failure patients.13-16 OptiVol 2.0, an enhanced version of the original OptiVol feature, is available in the Medtronic Viva XT, Viva S, and other Medtronic CRT-D devices.
OptiVol 2.0 enhancements include17:
Reduced Unexplained Detections17
Detail - Unexplained Detections
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.
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: Results of the Adaptive CRT Trial. Heart Rhythm. November 2012;9(11):1807-1814.
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.
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, Leon AR, Hannon C, et al. Results of the InSync III Marquis clinical trial. Heart Rhythm. May 2005;2(5):S65.
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.
Sawchuk R, Younker G. Projected Service Life: ACRT Longevity Improvement over Protecta. 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.)
Flo, Daniel. CRT-D IS4/DF4 Device Shape Analysis. April 2012. Medtronic data on file.
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.
Tang WH, Warman EN, Johnson JW, et al. Threshold crossing of device-based intrathoracic impedance trends identifies relatively increased mortality risk. Eur Heart J. September 2012;33(17):2189-2196.
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.
Small RS, Wickemeyer W, Germany R, et al. Changes in intrathoracic impedance are associated with subsequent risk of hospitalizations for acute decompensated heart failure: clinical utility of implanted device monitoring without a patient alert. J Card Fail. August 2009;15(6):475-481.
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™ XT CRT-D Specifications
IS1/DF4 (Model DTBA2D4) and IS1/DF1 (Model DTBA2D1) | |
---|---|
Volume * |
35 cm3 |
Mass | 80 gr |
H x W x D |
73 mm x 51 mm x 13 mm (IS1/DF4) 71 mm x 51 mm x 13 mm (IS1/DF1) |
*Volume with connector holes unplugged
See the appropriate Medtronic Clinician Manual for more information.
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.
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: Results of the Adaptive CRT Trial. Heart Rhythm. November 2012;9(11):1807-1814.
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.
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, Leon AR, Hannon C, et al. Results of the InSync III Marquis clinical trial. Heart Rhythm. May 2005;2(5):S65.
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.
Sawchuk R, Younker G. Projected Service Life: ACRT Longevity Improvement over Protecta. 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.)
Flo, Daniel. CRT-D IS4/DF4 Device Shape Analysis. April 2012. Medtronic data on file.
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.
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: Results of the Adaptive CRT Trial. Heart Rhythm. November 2012;9(11):1807-1814.
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.