CARDIOVASCULAR
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MORE OPTIONS TO MAKE NON-RESPONSE A NON-ISSUE

The Quadra Assura MP™ CRT-D brings MultiPoint™ Pacing, an exclusive Abbott technology, to cardiac resynchronization therapy defibrillators (CRT-Ds). The Quadra Assura MP CRT-D and Quartet™ quadripolar LV pacing lead feature four pacing electrodes and 10 pacing vectors, providing more options and greater control to minimize implant complications such as diaphragmatic stimulation and high pacing threshold.

THIS DEVICE IS COMMERCIALLY AVAILABLE FOR USE IN SELECT INTERNATIONAL MARKETS

 

Quadra Assura MP CRT-D is an MRI Ready device when used in combination with MR Conditional leads. This device has been tested for safe performance of an MRI scan using a 1,5 T (Tesla) field-strength MRI scanner.a,b

ONE LEAD. TWO IMPULSES. MORE OPTIONS TO MANAGE CRT RESPONSE.

With MultiPoint™ Pacing, Abbott has built on the quadripolar standard of care to offer more pacing options for your patients. MultiPoint Pacing delivers two LV pulses from a single Quartet™ LV lead for greater tissue capture.1-3

MULTIPOINT™ PACING RESULTS
U.S. IDE Study: Evidence for Improved Outcomes4

The recent IDE study1 post-hoc subanalysis (n = 147) showed that wider cathode spacing and near-simultaneous intraventricular timing delays provide best MPP™ technology response at 87 percent and “super-response” at 54 percent (52 patients).4

See details of the U.S. IDE study and other clinical support for MultiPoint Pacing.

MultiPoint™ Pacing Has Also Demonstrated:
  • 90% response rate with MultiPoint Pacing at 12 months measured by ESV decrease > 15%5
  • 95% response rate with MultiPoint Pacing at 12 months measured by ≥ 1 decrease in NYHA class5
  • 90% response rate with MultiPoint Pacing at 12 months measured by Packer’s score5
  • 19% absolute improvement in patients for CRT response at 12 months when compared to traditional biventricular (BiV) pacing with a quadripolar lead6
  • 44% relative reduction in nonresponders at 12 months when compared to traditional BiV pacing with a quadripolar lead6
ELECTRICAL, MECHANICAL AND HEMODYNAMIC BENEFITS
  • MultiPoint Pacing was able to recruit a greater portion of the LV than traditional BiV pacing, resulting in reduced activation times and QRS duration.7
  • MultiPoint Pacing reduced mechanical dyssynchrony by more than 20% as measured with tissue Doppler imaging in 63% of 41 patients tested.2
  • MultiPoint Pacing improved acute LV contractility assessed with pressure wire in 84% of patients compared to BiV pacing.8
  • Multiple studies have shown improvement in QRS duration, EF and ESV at six months.9-11
ENHANCED PROGRAMMING OPTIONS WITH QUADRA ASSURA MP™ CRT-D
  • SyncAV™ CRT technology automatically adjusts pacing based on real-time changes in a patient's cardiac condition.
  • Auto VectSelect Quartet™ Test elevates response easily, offering an efficient workflow for complete results and programming at the touch of a button.
  • Antitachycardia pacing (ATP) while charging and prior to charging in the VF zone further extends the programming options for terminating tachyarrhythmias without a high-voltage shock.
  • SenseAbility™ feature provides flexibility to fine-tune programming around T-wave oversensing without decreasing sensitivity.
ADDITIONAL MONITORING AND SAFETY FEATURES OF QUADRA ASSURA MP™ CRT-D
  • ShockGuard™ technology with DecisionTx™ programming
  • SecureSense™ RV lead noise discrimination
  • Far Field MD™ morphology discrimination
  • DeFT Response™ technology
  • CorVue™ congestion monitoring feature
  • QuickOpt™ timing cycle optimization
BUILDING COMPREHENSIVE HEART FAILURE MANAGEMENT

The Quadra Assura MP™ CRT-D Is one of our heart failure management therapies. Our vision is to transform the treatment of heart failure by designing technology that delivers excellent clinical outcomes and improves workflow and efficiency. Read more about our approach to heart failure management.

RESOURCES AND DOCUMENTATION

PRODUCT MANUALS (INSTRUCTIONS FOR USE)

MRI READY RESOURCES AND SCAN PARAMETERS

REFERENCES

a. MRI Conditional Field Strength: 1,5 Tesla.
b. See MRI Ready Systems Manual for approved MR Conditional Systems Device/Lead combinations and scan parameters.
1. Pappone, C., Calovic, Z., Vicedomini, G., Cuko, A., McSpadden, L. C., Ryu, K., … Santinelli, V. (2014). Multipoint left ventricular pacing improves acute hemodynamic response assessed with pressure-volume loops in cardiac resynchronization therapy patients. Heart Rhythm, 11(3), 394-401. http://dx.doi.org/10.1016/j.hrthm.2013.11.023
2. Rinaldi, C. A., Kranig, W., Leclercq, C., Kacet, S., Betts, T., Bordachar, P. … Nagvi, T. Z. (2013). Acute effects of multisite left ventricular pacing on mechanical dyssynchrony in patients receiving cardiac resynchronization therapy. Journal of Cardiac Failure, 19(11), 731-738. http://dx.doi.org/10.1016/j.cardfail.2013.10.003
3. Endrj, M., Ballari, G. P., Goletto, C., Rossetti, G., & Vado, A. (2015). Characterization of ventricular activation pattern and acute hemodynamics during multipoint left ventricular pacing. Heart Rhythm, 12(8), 1762-1769. http://dx.doi.org/10.1016/j.hrthm.2015.04.029
4. Niazi I, et al. Safety and efficacy of multipoint pacing in cardiac resynchronization therapy—the multipoint pacing trial. JACC. 2017;3(11):1519-1522. http://dx.doi.org/10.1016/j.jacep.2017.06.022. Accessed July 31, 2018.

5. Zanon, F., Marcantoni, L., Baracca, E., Pastore, G., Lanza, D., Fraccaro, C., . . . Prinzen, F. W. (2016). Optimization of left ventricular pacing site plus multipoint pacing improves remodeling and clinical response to cardiac resynchronization therapy at 1 year. Heart Rhythm, 13(8), 1644-1651.
6. Pappone, C., Ćalović, Ž., Vicedomini, G., Cuko, A., Mcspadden, L. C., Ryu, K. … Santinelli, V. (2015). Improving cardiac resynchronization therapy response with multipoint left ventricular pacing: Twelve-month follow-up study. Heart Rhythm, 12(6), 1250-1258. http://dx.doi.org/10.1016/j.hrthm.2015.02.008
7. Menardi, E., Ballari, G. P., Goletto, C., Rossetti, G., & Vado, A. (2015). Characterization of ventricular activation pattern and acute hemodynamics during multipoint left ventricular pacing. Heart Rhythm, 12(8), 1762-1769. http://dx.doi.org/10.1016/j.hrthm.2015.04.029
8. Thibault, B., Dubuc, M., Khairy, P., Guerra, P. G., Macle, L, Rivard, L., … Farazi, T. G. (2013). Acute haemodynamic comparison of multisite and biventricular pacing with a quadripolar left ventricular lead. Europace, 15(7), 984-991. http://dx.doi.org/10.1093/europace/eus435
9. Forleo, G. B., Santini, L., Zanon, F., Di Stolfo, G., Baracca, E., Lucciola, M. T., ... Potenza, D. R. (2015). A new algorithm for multi point pacing in cardiac resynchronization therapy: Feasibility from a multicenter experience. Heart Rhythm, 12(Suppl. 5), S220, HRS poster PO02-190.
10. Forleo, G. B., Santini, L., Potenza, D., Di Stolfo, G., Locatelli, A., Baracca, E., ... Zanon, F. (2015). Impact of Multi-point left ventricular pacing on QRS duration and left ventricular ejection fraction: Preliminary results from a multicenter prospective study. Heart Rhythm, 12(Suppl. 5), S388, HRS poster PO04-183.
11. Park, S. J., Chun, K., & Park, K. (2015) More favorable electrical and mechanical reverse remodeling after cardiac resynchronization therapy with quadripolar versus conventional bipolar lead. Heart Rhythm, 12(Suppl. 5), HRS abstract AB28-05.

A GROWING BODY OF EVIDENCE FOR MULTIPOINT™ PACING

THE U.S. IDE STUDY
Meeting Safety and Efficacy Endpoints1

The recent MultiPoint™ Pacing U.S. IDE study from Tomassoni et al. showed:

  •  Safety: 93.2% freedom from system-related complications1
  •  Efficacy: MultiPoint™ Pacing technology demonstrated to be noninferior to biventricular (BiV) with respect to non-responder rate1
Converting Non-Responders To Responders1

The subanalysis study demonstrated that wider cathode spacing and near-simultaneous intraventricular timing delays are best. When MultiPoint™ Pacing technology was programmed with cathode spacing ≥ 30 mm and 5 ms left ventricular (LV) delay:

  • CRT response rate was greatest at 87% and the super-responder rate was greatest at 54% (n = 52)1
  • Non-responders were converted to responders (8 of 8 patients)1

Conclusions from the U.S. IDE study include:

  • MultiPoint™ Pacing technology is safe and effective1
  • The enrolled patient population had a high response rate to quadripolar BiV pacing1
  • MultiPoint™ Pacing technology response rates for this patient population are greatest when devices are programmed with wide LV electrode spacing and short intraventricular delay1
  • There is a growing body of evidence that MultiPoint™ Pacing is a feature that physicians can use to potentially improve responder rates1
Responder vs nonresponder graph
FURTHER STUDIES SHOWING IMPROVEMENTS IN CRT RESPONSE RATE2-4

Several studies have demonstrated the potential to improve patient response to CRT with MultiPoint Pacing.

Responder rate graphic
Improvements of CRT Response Rate at 12 Months

Zanon et al. compared 20 patients optimized with MultiPoint Pacing to 36 patients optimized with traditional BiV pacing and 54 nonoptimized BiV patients.2 The results indicate a clear progression in response from nonoptimized BiV to optimized BiV to optimized with MultiPoint Pacing at 12 months consistently measured over three definitions of response:

  • 90% response rate with MultiPoint Pacing measured by ESV decrease > 15%2
  • 95% response rate with MultiPoint Pacing measured by ≥ 1 decrease in NYHA class2
  • 90% response rate with MultiPoint Pacing measured by Packer’s score2
MPP tech 1 year data
Additional CRT Response Rate Clinical Data
  • After 12 months, 57% of patients in the conventional BiV group and 76% of patients in the MultiPoint Pacing group were classified as positive responders.3
  • NYHA class reduction was also greater within the MultiPoint Pacing group.3
MPP comparison chart
MPP response comparison chart
  • 44% relative reduction in non-responders over a 12-month period, as measured by reduction in end systolic volume (ESV)4
  • 19% percent higher absolute response over a 12-month period, as measured by reduction in ESV5
12 Month CRT Response Rate graphic
12 Month CRT Response Rate graphic
MULTIPOINT™ PACING HAS IMPROVED CARDIAC FUNCTION AND HEMODYNAMICS

Multiple studies have demonstrated the benefits of MultiPoint™ Pacing (MPP™) technology in improving electrical propagation, acute hemodynamics and dyssynchrony.2,6-11

MultiPoint Pacing technology has also been shown to:

Reduce ESV and Improve EF

Multiple studies have shown improvement in QRS duration, ejection fraction (EF) and end systolic volume (ESV) at six months.4,6,7

Improve Hemodynamic8,9 and Acute Hemodynamic Response6,10
  • MPP™ technology significantly increased the rate of pressure change, stroke work, stroke volume and ejection fraction.6
  • MPP technology improved acute diastolic function, significantly decreasing dP/dtmin, relaxation time constant and end-diastolic pressure.6
  • MPP technology improved acute LV hemodynamic parameters.6
  • MPP technology improved hemodynamics performance.9
  • Hemodynamic improvement continued for one month during the course of the study.9
  • 72% of all tested configurations of multisite pacing produced greater LV dP/dtmax than obtained with BiV pacing.11
Improve Acute Cardiac Contractility8

MultiPoint Pacing delivered via a quadripolar LV lead resulted in a significant improvement in acute cardiac contractility compared to conventional CRT in the majority of patients studied.

Reduce Echocardiographic Dyssyncrhony7
  • At least one MultiPoint Pacing configuration exhibited a significant dyssynchrony improvement in 63% of patients.
  • Mean number of LV segments with delayed longitudinal contractions was significantly reduced with the optimal MultiPoint Pacing configuration.

MultiPoint Pacing was safe and resulted in a significant reduction in echocardiographic dyssynchrony compared with conventional CRT.

BUILDING COMPREHENSIVE HEART FAILURE MANAGEMENT

The Quadra Assura MP™ CRT-D Is one of our heart failure management therapies. Our vision is to transform the treatment of heart failure by designing technology that delivers excellent clinical outcomes and improves workflow and efficiency. Read more about our approach to heart failure management.

RESOURCES AND DOCUMENTATION
REFERENCES

1. Niazi et al Safety and Efficacy of Multipoint Pacing in Cardiac Resynchronization Therapy –The MultiPoint Pacing Trial JACC 2017 http://dx.doi.org/10.1016/j.jacep.2017.06.022.
2. Zanon, F., Marcantoni, L., Baracca, E., Pastore, G., Lanza, D., Fraccaro, C., . . . Prinzen, F. W. (2016). Optimization of left ventricular pacing site plus multipoint pacing improves remodeling and clinical response to cardiac resynchronization therapy at 1 year. Heart Rhythm, 13(8), 1644-1651..
3. Pappone, C., Calovic, Z., Cuko, A., McSpadden, L. C., Ryu, K., Baldi, M., … Santinelli, V. (2013). Multisite left ventricular pacing in a single coronary sinus branch improves 3-month echocardiographic and clinical response to cardiac resynchronization therapy. Journal of Cardiac Failure, 19(8S), S26. http://dx.doi.org/10.1016/j.cardfail.2013.06.087
4. Ypenburg, C., van Bommel, R., J., Borlefs, C. J., Bleeker, G. B., Boersma, E., Schalij, M. J.,& Bax, J. J. (2009). Long-term prognosis after cardiac resynchronization therapy is related to the extent of left ventricular reverse remodeling at midterm follow-up. Journal of the American College of Cardiology, 53(6), 483-490. http://dx.doi.org/10.1016/j.jacc.2008.10.032
5. Endrj, M., Ballari, G. P., Goletto, C., Rossetti, G., & Vado, A. (2015). Characterization of ventricular activation pattern and acute hemodynamics during multipoint left ventricular pacing. Heart Rhythm, 12(8), 1762-1769. http://dx.doi.org/10.1016/j.hrthm.2015.04.029
6. Pappone, C., Calovic, Z., Vicedomini, G., Cuko, A., McSpadden, L. C., Ryu, K., … Santinelli, V. (2014). Multipoint left ventricular pacing improves acute hemodynamic response assessed with pressure-volume loops in cardiac resynchronization therapy patients. Heart Rhythm, 11(3), 394-401. http://dx.doi.org/10.1016/j.hrthm.2013.11.023
7. Rinaldi, C. A., Kranig, W., Leclercq, C., Kacet, S., Betts, T., Bordachar, P. … Nagvi, T. Z. (2013). Acute effects of multisite left ventricular pacing on mechanical dyssynchrony in patients receiving cardiac resynchronization therapy. Journal of Cardiac Failure, 19(11), 731-738. http://dx.doi.org/10.1016/j.cardfail.2013.10.003
8. Rinaldi, C. A., Leclercq, C., Kranig, W., Kacet, S., Betts, T., Bordachar, P., … Magvi, T. Z. (2014). Improvement in acute contractility and hemodynamics with Multipoint pacing via a left ventricular quadripolar pacing lead. Journal of Interventional Cardiac Electrophysiology, 40(1), 75-80. http://dx.doi.org/10.1007/s10840-014-9891-1
9. Gutleben, K., Kranig, W., Barr, C., Morgenstern, M., Simon, M., & Lee, K. (2012, May). Multisite left ventricular pacing is safe and improves cardiac hemodynamic in heart failure patients–Results from a 1-month follow-up study. Presented at the meeting of the Heart Rhythm Society, Boston, MA.
10. Pappone, C. (2014, May). Multipoint left ventricular pacing in cardiac resynchronization therapy Patients provides similar acute hemodynamic improvement regardless of QRS duration or lead location. Presented at the meeting of the Heart Rhythm Society, San Francisco, CA.
11. Thibault, B., Dubuc, M., Khairy, P., Guerra, P. G., Macle, L, Rivard, L., … Farazi, T. G. (2013). Acute haemodynamic comparison of multisite and biventricular pacing with a quadripolar left ventricular lead. Europace, 15(7), 984-991. http://dx.doi.org/10.1093/europace/eus435

 

QUADRA ASSURA MP™ CARDIAC RESYNCHRONISATION THERAPY DEFIBRILLATOR (CRT-D)

CD3371-40 and CD3371-40Q

Contents: Cardiac pulse generator

ORDERING INFORMATION 

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Dimensions (H x W x T, mm)

 

Weight (g)

 

Volume (cc)

 

Connector

CD3371-40Q 74 x 41 x 14 80 38 DF4, IS4, IS-1


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