Healthcare Professionals

Viva S CRT-D

Cardiac Resynchronization Therapy Defibrillators (CRT-D)

  • Viva S CRT-D Device

Viva S Cardiac Resynchronization Therapy Defibrillators (CRT-D)

Viva™ S CRT-D devices feature the Ensure CRT™ Suite, five integrated algorithms that automatically work together to ensure CRT delivery during challenging conditions.1-7 CRT non-response is a significant unmet medical need affecting up to one-third of patients implanted with CRT devices.8-13 The new PhysioCurve™ contoured Viva S CRT-D has increased device longevity14 and enhances patient comfort.15

 

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.8-13

Many factors contribute to CRT non-response, including suboptimal AV timing, suboptimal LV lead placement, presence of arrhythmias, and reduced BiV pacing.16

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 Response8-13

Adequate CRT Response

Detail - Adequate CRT Response

Potential Factors Contributing to Suboptimal CRT Response16

Suboptimal CRT Response

Detail - Suboptimal CRT Response

Expand All

Ensure CRT Suite

Ensure CRT Suite

The Ensure CRT™ Suite, available in the Medtronic Viva™ S CRT-D device, is designed to address conditions that can interrupt CRT response:

  • Suboptimal AV/VV timings16
  • Atrial fibrillation17
  • Threshold elevation18

The Ensure CRT Suite incorporates five integrated algorithms that automatically work together during these challenging conditions to ensure CRT delivery.19

Five Algorithms Address Challenging Conditions

Ensure CRT Algorithms

Detail - Ensure CRT Graph

Learn more about the Ensure CRT Suite.

Important Safety Information

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. Please refer to the Instructions For Use for complete safety Information, potential complications, Indications, Contraindications, Warnings and Precautions.

References

1

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.

2

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.

3

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.

4

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.

5

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.

6

Crossley GH, Mead H, Kleckner K, et al. Automated left ventricular capture management. Pacing Clin Electrophysiol. October 2007;30(10):1190-1200.

7

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.

8

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.

9

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.

10

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.

11

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.

12

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

13

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.

14

Sawchuk R, Younker G. Projected Service Life: 10% 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.)

15

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

16

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.

17

Knight BP, Desai A, Coman J, et al. Long-term retention of cardiac resynchronization therapy. J Am Coll Cardiol. 2004; 44(1):72-77.

18

Crossley GH, Mead H, Kleckner K, et al. Automated left ventricular capture management. Pacing Clin Electrophysiol. 2007;30(10):1190-1200.

19

Medtronic Viva S CRT-D Technical Manual, Medtronic Inc.

PhysioCurve Design

SmartShock 2.0

OptiVol 2.0

Specs

References

1

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.

2

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.

3

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.

4

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.

5

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.

6

Crossley GH, Mead H, Kleckner K, et al. Automated left ventricular capture management. Pacing Clin Electrophysiol. October 2007;30(10):1190-1200.

7

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.

8

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.

9

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.

10

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.

11

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.

12

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

13

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.

14

Sawchuk R, Younker G. Projected Service Life: 10% 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.)

15

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

16

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 .