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Claria MRI Quad CRT-D

Cardiac Resynchronization Therapy Defibrillators (CRT-D)

Claria MRI Quad CRT-D SureScan

Maximize CRT response with the Claria MRI™ Quad CRT-D SureScan™ with 1.5T And 3T MRI full-body MRI scanning access

With the Claria MRI™ Quad CRT-D SureScan™ System, your patients have access to 1.5T and 3T full-body MRI scanning and advanced technologies to maximize CRT response, including the Attain™ Performa™ Quadripolar LV Lead, VectorExpress™ LV Automated Test, AdaptivCRT™, EffectivCRT™, and Multiple Point Pacing.

The Attain Performa Quadripolar LV Lead has four electrodes and 21 pacing configurations, offering more pacing possibilities. VectorExpress LV Automated Test provides data for all vectors in two minutes,1 enabling selection of a pacing location that maximizes longevity. Multiple Point Pacing allows pacing from two LV electrodes instead of one, which may be used as an option to improve CRT response for some nonresponders. AdaptivCRT preserves natural heart rhythms and improves CRT response.2 The EffectivCRT™ diagnostic reveals the quality of CRT pacing (% Effective CRT) on top of the quantity of pacing (% Ventricular pacing), whereas the EffectivCRT™ during AF algorithm uses this data to maximize effective CRT pacing during AF.

Key features

Tesla MRI scanning

Expanded MRI Access

41% of CRT patients are likely to have an MRI scan ordered over four years, yet only about 0.43% of them undergo an MRI scan.3

Now, with Amplia MRI, patients have access to full-body 1.5 and 3 Tesla MRI scanning. Medtronic SureScan devices and leads work in any combination to provide simplified scanning conditions.

Medtronic engineered these devices with enhancements to ensure patient safety against:

  • Force, torque, and heating
  • Unintended cardiac stimulation
  • Device interactions in the MRI

EffectivCRT diagnostic

EffectivCRT diagnostic

% Ventricular Pacing in CRT devices is simply a counter of ventricular paces the device delivers but may not reflect the true proportion of left ventricular(LV) capture. The EffectivCRT metric is a pioneering CRT device diagnostic that fills this gap. It assesses the percentage of effective LV capture based on beat-by-beat evaluation of morphology of LV electrogram available from the device. This information is provided in the already existing Quick Look screen, rate histograms and cardiac compass report. Additionally, episodes of ineffective CRT are stored in the device, which enables the physician to troubleshoot and act upon possible reasons for ineffective CRT The EffectivCRT Diagnostic may help maximize response to CRT. The EGM-based algorithm, which is the basis of EffectivCRT, was validated against surface ECG and showed 98% sensitivity in determination of effective pacing.4

The EffectivCRT during AF algorithm

This is a first-of-its-kind device algorithm which dynamically adjusts the ventricular pacing rate during AF based on morphology of paced LV EGM, to maximize effective resynchronization pacing. The number of effective paces, pseudo-fusion and ventricular-sense beats during AF are tracked and the ventricular pacing rate is decreased or increased based on this. The maximum rate is programmable. This algorithm helps deliver more effective CRT pacing during AF with minimal increase in average heart rate over the intrinsic rate.

AdaptivCRT Algorithm

The AdaptivCRT algorithm continuously and dynamically adapts CRT pacing method and AV/VV delays. By promoting intrinsic RV conduction, AdaptivCRT reduces RV pacing and increases device longevity for patients with normal AV conduction.

The algorithm has been shown to improve patient outcomes by:

  • Providing a 46% reduction in AF risk5
  • Improving CRT Response by 12% for patients with normal AV conduction6
  • Reducing a patient's odds of a 30-day HF hospital readmissions by 59%7
AdaptivCRT Algorithm

Attain Performa LV lead

The Attain Performa Family of leads, compatible with all Attain™ delivery systems, have four electrodes to help physicians optimize cardiac resynchronization therapy delivery. The leads address the clinical challenges that can compromise lead position, offering implanting physicians more options to treat varying anatomies.

Attain Performa LV lead

Three shape options for varying patient anatomies: Compatible with Medtronic sub-selection catheters

Short bipolar spacing: Reduces phrenic nerve stimulation occurrence8

Steroid on all electrodes: Improves thresholds and longevity9

Approved for 1.5T and 3T MRI with no changes to the lead design

VectorExpress LV Automated Test

VectorExpress™ is an automated test providing clinically actionable data on all vectors in two minutes.1

  • Eliminates the need for manual, time-consuming testing of multiple vectors
  • Helps to maximize longevity, select pacing location, and optimize CRT response1
  • Find the time difference between RVs and LVs for each electrode on the quad lead and identify the electrode at the site of latest activation

VectorExpress LV Automated Test

Multiple Point Pacing

Multiple Point Pacing
  • Allows pacing from two LV electrodes instead of one
  • Option to improve CRT Response in some nonresponders
  • New Multiple Point Pacing vectors are included in VectorExpress™
  • Works in combination with AdaptivCRT

SmartShock Technology 2.0

Reducing Inappropriate Shocks

SmartShock™ Technology uses algorithms to discriminate true lethal arrhythmias from other arrhythmic and nonarrhythmic events. SmartShock Technology dramatically reduces the incidence of inappropriate shocks while maintaining sensitivity.10-12 In the PainFREE SST Trial, 98.5% of dual-chamber and triple-chamber patients and 97.5% of single-chamber patients were free from inappropriate shocks at one year with SmartShock Technology.10

Patient comfort by Physio Curve

The new CRT-D’s increase patient comfort. Its Physio Curve design with rounded shape and thin, soft edges adapts to the body and reduces the pressure on the skin.

OptiVol 2.0 Fluid Status Monitoring

Identifying Lung Congestion in Patients with Heart Failure

Lung Congestion

OptiVol™ Fluid Status Monitoring tracks intrathoracic impedance changes over time to help clinicians assess lung congestion in patients with heart failure. Heart Failure device diagnostics, with multiple physiologic trends including OptiVol, are proven to identify patients at high risk for heart failure hospitalization.13-20

OptiVol Monitoring detects three times more future heart failure events than weight monitoring alone.13


References

1

Demmer W. VectorExpress Performance Results. Medtronic data on file. January 2013.

2Martin 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.

3

Medtronic data on file 2016: Data from MarketScan® 2012 Commercial and Medicare Database, Truven Health Analytics.

4

Ghosh S, et al. Europace, 2015. doi: 10.1093/europace/euv062

5

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.

6Birnie D, et al. Improved clinical outcomes with synchronized left-ventricular only pacing by an automated cardiac resynchronization therapy algorithm: analysis of the adaptive CRT trial. Presented at the American Heart Association Scientific Sessions, November 2012, Los Angeles, Calif. Abstract #: 11672.

7Starling RC, Krum H, Bril S, et al. Impact of Novel Adaptive Optimization Algorithms on 30-Day Readmissions. Evidence from the Adaptive CRT Trial. Heart Rhythm. 2014;11(5)(Suppl.):S155.

8Biffi M, Foerster L, Eastman W, et al. Effect of bipolar electrode spacing on phrenic nerve stimulation and left ventricular pacing thresholds: an acute canine study. Circ Arrhythm Electrophysiol. August 1, 2012;5(4):815-820.

9Lunati MG, Gasparini M, Landolina M, et al. Long-term effect of steroid elution on the electrical performance of coronary sinus leads for cardiac resynchronization therapy . Presented at HRS 2012 (AB10-05).

10Volosin, 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.

11

Protecta Clinical Study, Medtronic data on file.

12Auricchio A, Schloss EJ, Kurita T, et al. Low inappropriate shock rates in patients with single- and dual/triple-chamber implantable cardioverter-defibrillators using a novel suite of detection algorithms: PainFree SST trial primary results. Heart Rhythm. May 2015;12(5):926-936.

13Yu 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. 2005;112(6):841-848.

14Abraham WT. 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. 2009;15(9):813.

15Small 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.

16Whellan 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.

17Tang WH, Warman EN, Johnson JW, et al. Threshold crossing of device-based intrathoracic impedance trends identifies relatively increased mortality risk. Eur Heart J. 2012;33(17):2189-2196.

18Small 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. 2012;18(8 Suppl):S50.

19Whellan 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.

20 Sarkar S, Hettrick DA, Koehler J, et al. Improved algorithm to detect fluid accumulation via intrathoracic impedance monitoring in heart failure patients with implantable