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

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.

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.

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

The new PhysioCurve™ design for the Medtronic Viva™ S CRT-D devices features a physiologic contoured shape for enhanced patient comfort.15

The Viva S CRT-D also has 10% increased device longevity14* and maintains 35 J output for ALL shocks.16

*As compared to Protecta XT CRT-D. Assumptions for Viva 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 Viva S manual.

 

The PhysioCurve Design

PhysioCurve Design

Detail – PhysioCurve Design

Using a proprietary comparative shape pressure analysis, the contoured shape of PhysioCurve (Viva S CRT-D IS1/DF4) resulted in a 30% reduction in skin pressure compared to non-contoured devices (CRT-D IS1/DF4).15 (Red areas indicate high skin pressure.)

Pressure Analysis

Detail – Pressure Analysis

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.

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. Medtronic Viva S CRT-D Technical Manual.

Smart Shock Technology 2.0

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.16,17

SmartShock-image1 

Detail – Chart

SmartShock Technology has been enhanced to improve long-term shock reduction, while simplifying device programming. SmartShock 2.0 includes the following:

  • New nominal settings for number of intervals to detect (NID); now at 24/32
  • T wave discrimination is now applied when even sensed events are ≥ 32 mV, which improves algorithm recognition of T wave oversensing (TWOs) with very large R waves
  • An interaction between TWOs and lead noise discrimination (LND) algorithms has been removed to improve recognition of lead noise episodes

Learn more about SmartShock 2.0 Technology.

Important Safety Information

For CRT-Ds, certain programming and device operations may not provide cardiac resynchronization. Changes in patient’s disease and/or medications may alter the efficacy of the device’s programmed parameters.

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. 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.
  17. 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,17,18 identify patients with long-term mortality risk,19 and potentially avoid hospital readmissions for their heart failure patients.20-23 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 include24:

  • Improved ability to track intrathoracic impedance changes
  • Less aggressive fluid index accumulation for an initial duration of the event in patients with higher day-to-day variability in impedance
  • A limit to fluid index accumulation of less than 30 days
  • A reduction of unexplained detections by >40%

Reduced Unexplained Detections24

Unexplained Detections 

Detail - Unexplained Detections

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.

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. 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.
  18. 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.
  19. 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.
  20. 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.
  21. 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.
  22. 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.
  23. 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.
  24. 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™ S CRT-D Specifications

IS1/DF4 (Model DTBB2D4) and IS1/DF1 (Model DTBB2D1)

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.

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.
Last updated: 24 Jun 2013

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