Unique Features

Implantable Cardiac Devices

Ensure CRT Suite

Clinical Need

Studies have shown that up to one-third of patients do not experience all of the benefits of cardiac resynchronization therapy (CRT).1-6

Multiple conditions can hamper CRT response:

  • Suboptimal AV/VV timings -- occurs in 45% of CRT non-responders7
  • Atrial fibrillation (AF) -- the single, largest cause of CRT non-response8
  • Threshold elevation -- may lead to loss of CRT and requires in-office follow-up visits to manage LV capture concerns9
     

Percentage of Patients with Adequate CRT Response1-6

Adequate CRT Response

Detail - Adequate CRT Response

Potential Factors Contributing to Suboptimal CRT Response7

Suboptimal CRT Response

Detail - Suboptimal CRT Response

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. Abraham WT, Fisher WG, Smith AL, et al. Cardiac resynchronization in chronic heart failure. NEJM. 2002;346(24):1845-1853.
  2. 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. 2004;110(18):2864-2868.
  3. Abraham WT, Leon AR, Hannon C, et al. Results of the InSync III Marquis clinical trial. Heart Rhythm. 2005;2(5): S65.
  4. Abraham WT, Gras D, Yu CM, et al. Results from the FREEDOM Trial - assess the safety and efficacy of frequent optimization of cardiac resynchronization therapy. Presented at the Heart Rhythm Society annual scientific session, Denver, CO, May 2010.
  5. 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. 2003;289(20):2685-2694.
  6. Chung ES, Leon AR, Tavazzi L, et al. Results of the Predictors of Response to CRT (PROSPECT) Trial. Circulation. 2008;117(20):2608-2616.
  7. 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.
  8. Knight BP, Desai A, Coman J, et al. Long-term retention of cardiac resynchronization therapy. J Am Coll Cardiol. July 7, 2004;44(1):72-77.
  9. Crossley GH, Mead H, Kleckner K, et al. Automated left ventricular capture management. Pacing Clin Electrophysiol. October 2007; 30(10):1190-1200.

How It Works

The Ensure CRT™ Suite features five integrated algorithms that automatically work together to address conditions that can interrupt CRT response.1


Ensure CRT Algorithms Versus CRT Non-response

Ensure CRT Algorithms 

Detail - Ensure CRT Algorithms

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. Medtronic Viva S CRT-D Technical Manual, Medtronic Inc.
  2. Mullens W, Grimm RA, Verga T, et al. Insights from a cardiac resynchronization optimization clinic as part of a heart failure disease management program. J Am Coll Cardiol. March 3, 2009;53(9):765-773.
  3. Knight BP, Desai A, Coman J, et al. Long-term retention of cardiac resynchronization therapy. J Am Coll Cardiol. July 7,2004;44(1):72-77.
  4. Crossley GH, Mead H, Kleckner K, et al. Automated left ventricular capture management. Pacing Clin Electrophysiol. October 2007;30(10):1190-1200.

CardioSync

CardioSync® optimizes CRT and reduces loss of BiV pacing due to inappropriate AV/VV programming.1 CardioSync takes P-wave duration and intrinsic AV interval into account when optimizing AV delays to preempt ventricular activation.2

CardioSync offers an alternative to time-consuming echo optimization:1,2

  • Simple, one-click AV and VV optimization during patient follow-up to initiate a test2,3
  • In-office test takes no more than 45 seconds3
  • Recommends CRT parameters based on intrinsic AV intervals and P and QRS waveform widths2
  • Similar cardiac performance as echo optimization1,4

In a clinical study, CardioSync reduced loss of CRT response when compared to echo optimization.1 In a sub-analysis of 313 patients, using settings as recommended by CardioSync resulted in no patients with ≤ 90% BiV pacing due to inappropriate AV/VV programming.1

Percentage of patients 

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:S53-54.
  2. Medtronic Viva S CRT-D Technical Manual, Medtronic, Inc.
  3. Munsterman N. CardioSync Timing. Medtronic data on file. October 2012.
  4. 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. 2012;9(11):1807-1814.

AF and CRT

Three algorithms in the Ensure CRT Suite are designed to maximize CRT response even in the presence of atrial fibrillation:

  • Ventricular Sense Response (VSR)
  • Conducted AF Response (CAFR)
  • Atrial Tracking Recovery (ATR)

Analysis of more than 80,000 patients from the Medtronic CareLink® database showed a significant decrease in patients with ≤ 90% BiV pacing when VSR, CAFR, and ATR were turned “on.” 1

BiV pacing 

Detail - BiV pacing

Ventricular Sense Response (VSR)

VSR maintains BiV pacing when an RV sense occurs. VSR provides significant improvement in cardiac function compared to no CRT at all.2,3

Ventricular Sense Response 

Detail - Ventricular Sense Response

Conducted AF Response (CAFR)

CAFR increases the percentage of BiV pacing in the presence of AF without raising the mean ventricular rate.4 This algorithm dynamically changes the mode switch pacing rate on a beat-to-beat basis.5

Conducted AF Response 

Detail - Conducted AF Response

Atrial Tracking Recovery (ATR)

ATR is designed to recover AV synchrony and CRT delivery if lost due to PVCs or a rapid 1:1 sinus rhythm. ATR temporarily shortens PVARP to regain atrial tracking.5

Atrial Tracking Recovery 

Detail - Atrial Tracking Recovery

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. Rogers T, Sambelashivilli A. Ensure CRT Suite data analysis overview. Medtronic data on file. September 2012.
  2. Aktas MK, Jeevanantham V, Sherazi E, et al. Effect of biventricular pacing during a ventricular sensed event. Am J Cardiol. June 15, 2009;103(12):1741-1745.
  3. Kloppe A, Kaup B, Dejan M, et al. Is right ventricular pacing necessary for hemodynamic benefit in CRT? Investigation of the ventricular sense response algorithm. Poster PO05-137. Presented at the European Society of Cardiology Scientific Meeting. Europace 2007.
  4. Tse HF, Newman D, Ellenbogen KA, et al. Effects of ventricular rate regularization pacing on quality of life and symptoms in patients with atrial fibrillation (Atrial Fibrillation Symptoms Mediated by Pacing to Mean Rates [AF SYMPTOMS Study]). Am J Cardiol. 2004;94:938-941.
  5. Medtronic Viva S Technical Manual, Medtronic, Inc.

 

Complete Capture Management

Complete Capture Management™ (CCM) automatically ensures pacing capture in all cardiac chambers.1 Pacing outputs automatically remain at safe levels while CCM actively manages battery current drain.1

Left Ventricular Capture Management

  • Automatically adapts to changing patient needs1
  • Potentially saves time in testing and measuring LV pacing thresholds during follow-up2
  • Clinically proven to be safe, accurate, and highly reliable3

Together with the Medtronic CareLink® Network, CCM provides the same in-depth device information as an office visit.1

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.

Learn more about Complete Capture Management.

References

  1. Medtronic Viva S Technical Manual, Medtronic, Inc.
  2. Murgatroyd FD, Hemling 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.
  3. Crossley GH, Mead H, Kleckner K, et al. Automated left ventricular capture management. Pacing Clin Electrophysiol. October 2007; 30(10):1190-1200.
Last updated: 3 Jun 2013

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