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VivaTM XT CRT-D

Cardiac Resynchronization Therapy Defibrillators (CRT-D)

  • Viva XT CRT-D Device

Viva XT 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

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.1-7

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

Adequate CRT Response

Detail - Adequate CRT Response

Potential Factors Contributing to Suboptimal CRT Response8

Suboptimal CRT Response

Detail - Suboptimal CRT Response

Important Safety 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.

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AdaptivCRT Algorithm

AdaptivCRT Algorithm

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

AdaptivCRT-Algorithm

Detail - AdaptivCRT Algorithm

Clinical Evidence

Clinical evidence shows that AdaptivCRT improves patient outcomes, compared to echo-optimized CRT,7,11-14 including:

  • 12% increase in CRT response rate for patients with normal AV conduction11
  • 47% reduction in 30-day heart failure readmissions following a heart failure hospitalization12
  • 46% reduction in atrial fibrillation risk13
  • 21% reduction in overall heart failure hospitalizations within the first year after implant14

Watch these videos to learn more about the AdaptivCRT algorithm.

AdaptivCRT Overview Video with Medtronic Scientists (3:19)

AdaptivCRT Algorithm Animation (3:10)

Important Safety 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.

References

1

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.

2

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.

3

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.

4

Abraham WT, Leon AR, Hannon C, et al. Results of the InSync III Marquis clinical trial. Heart Rhythm. May 2005;2(5):S65.

5

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.

6

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.

7

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.

8

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.)

9

Flo, Daniel. CRT-D IS4/DF4 Device Shape Analysis. April 2012. Medtronic data on file.

10

Medtronic Viva XT CRT-D Clinician Manual, Medtronic, Inc., Minneapolis, MN, USA.

11

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.

12

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.

13

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.

14

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.

PhysioCurve Design

SmartShock 2.0

OptiVol 2.0

Specs

References

1

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.

2

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.

3

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.

4

Abraham WT, Leon AR, Hannon C, et al. Results of the InSync III Marquis clinical trial. Heart Rhythm. May 2005;2(5):S65.

5

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.

6

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.

7

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.

8

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.