Consulta CRT-D
Cardiac Resynchronization Therapy Defibrillator (CRT-D)
Consulta Implantable Cardiac Resynchronization Therapy Defibrillator (CRT-D)

Consulta Cardiac Resynchronization Therapy Defibrillator (CRT-D)

Consulta® CRT-D is a high energy wireless device with Complete Capture Management™ and OptiVol® Fluid Status Monitoring.

How It Works

Consulta® CRT-D is the first and only completely automatic wireless device to combine industry-leading pacing and ICD exclusives – Complete Capture Management™ to ensure CRT therapy and OptiVol® Fluid Status Monitoring.

Along with the Attain® Left Heart Leads and Delivery Systems and remote patient care with CareLink® Network, Medtronic offers a comprehensive approach to CRT  patients – providing the tools to enable implant success, features for CRT assurance and insight into worsening heart failure.

Important Safety Information

Changes in a patient's disease and/or medications may alter the efficacy of a device's programmed parameters or related features.

Key Features

  • Exclusive OptiVol Fluid Status Monitoring to detect worsening heart failure
    • OptiVol Monitoring predicts worsening heart failure and can be used to risk-stratify patients for more frequent follow-up1-4
  • Exclusive Complete Capture Management (hot link) to ensure pacing capture in all heart chambers [Atrial Capture Management (ACM), Right Ventricular Capture Management (RVCM), Left Ventricular Capture Management (LVCM)]
  • Ensure CRT solutions maintain biventricular pacing during atrial fibrillation

Noninvasive Solutions for Complex Cases

  • Programmable RV sensing may resolve T-wave oversensing and other sensing issues that may lead to inappropriate shocks
  • Programmable SVC Coil can help avoid surgical intervention and enhance safety for patients
RevisedSVCcoilart

Programmable SVC Coil

References

  1. 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. [MID-Heft]
  2. Whellan DJ, Al-Khatib SM, Kloosterman EM, et al. Changes in intrathoracic fluid index predict subsequent adverse events: Results of the multi-site Program to Access and Review Trending INformation and Evaluate CoRelation to Symptoms in Patients with Heart Failure (PARTNERS HF) Trial. J Card Fail. 2008;14(9):799. [PARTNERS HF]
  3. 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. [OFISSER]
  4. 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. [FAST Study]
  5. Wathen MS, DeGroot PJ, Sweeney MO, et al, for the PainFREE Rx II Investigators. Prospective randomized multicenter trial of empirical antitachycardia pacing versus shocks for spontaneous rapid ventricular tachycardia in patients with implantable cardioverter-defibrillators: Pacing Fast Ventricular Tachycardia Reduces Shock Therapies (PainFREE Rx II) trial results. Circulation. October 26, 2004;110(17):2591-2596.

 

Clinical Need for Fluid Status Monitoring

Heart failure (HF) affects approximately 5.8 million Americans, and is the primary reason for over 1.1 million hospital admissions every year. The estimated direct and indirect cost of heart failure in the US for 2010 is $39.2 billion.1

  • Approximately 50% of HF costs can be attributed to hospitalizations for acute decompensated HF.2
  • Fluid volume overload (congestion) is a major complication for patients with moderate-to-severe HF and a frequent cause of hospital readmissions.3
  • Fluid accumulation in HF patients is often detected too late to avert hospitalization.4
OptiVolpuzzle-bth 

Detail - OptiVol Puzzle

Current Monitoring

  • Assessing heart failure congestion is challenging.5
  • Regular monitoring using body weight, blood pressure, and clinical symptoms does not always provide clarity and adequate time to prevent hospitalization.6-10

Patient Compliance Remains a Concern

  • Nearly half of hospital readmissions for HF were caused by medication or dietary nonadherence.9

OptiVol Fluid Status Monitoring Does Not Rely on Patient Compliance

OptiVol monitoring, together with Cardiac Compass® Report, is a tool that objectively tracks fluid status and several other physiologic trends, without relying on patient compliance.

 

References

  1. American Heart Association. Heart Disease and Stroke Statistics – 2010 Update.
  2. American Heart Association. Heart Disease and Stroke Statistics – 2004 Update. Dallas, TX: American Heart Association. 2004.
  3. Sackner-Bernstein J. What is heart failure and what are the treatment options? Complex questions. In: Hayes DL, Wang PJ, Sackner-Bernstein J, Asirvatham SJ, eds. Resynchronization and Defibrillation for Heart Failure: A Practical Approach. Oxford, England: Blackwell Publishing; 2004:1-2.
  4. Small RS. Integrating device-based monitoring into clinical practice: insights from a large heart failure clinic. Am J Cardiol. May 21, 2007;99(10A):17G-22G.
  5. Fonarow GC. How well are chronic heart failure patients being managed? Rev Cardiovasc Med. 2006;7(suppl 1):S3-11.
  6. Friedman MM. Older adults’ symptoms and their duration before hospitalization for heart failure. Heart Lung 1997;26:169 –176.
  7. Evangelista LS, Dracup K, Doering LV. Treatment-seeking delays in heart failure patients. J Heart Lung Transplant 2000;19:932–938.
  8. Stevenson LW, Perloff JK. The limited reliability of physical signs for estimating hemodynamics in chronic heart failure. JAMA 1989;261: 884–888.
  9. Vinson JM, Rich MW, Sperry JC, Shah AS, McNamera T. Early readmission of elderly patients with congestive heart failure. J Am Geriatr Soc 1990;38:1290 –1295.
  10. Abraham 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. Vol. 15 No. 9 2009, p 813. (FAST).

Complete Capture Management

Complete Capture Management™ and Medtronic CareLink® Network remote monitoring system provide fast and easy remote device follow-up of1:

  • Battery check
  • Unique threshold measurements and output adjustments (all chambers)
  • Sensing adjustments beat-to-beat
  • Impedance monitoring
  • HF patient diagnostics and monitoring

References

  1. Analysis from the German TEAM-Study, 2006. Medtronic Internal Data.

Specifications

Consulta Cardiac Resynchronization Therapy Defibrillator (CRT-D)

7.7 seconds BOS*
9.3 seconds RRT**
6.0 years longevity
38 cc, 68 g

 

* Beginning of Service
** Recommended Replacement Time

Reference

Medtronic Consulta CRT-D Clinician Manual.

Last updated: 30 Mar 2011

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