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

The Quadra Allure MP™ CRT-P brings MultiPoint™ Pacing, an exclusive Abbott technology, to cardiac resynchronization therapy pacemakers (CRT-Ps).

THIS DEVICE IS COMMERCIALLY AVAILABLE FOR USE IN SELECT INTERNATIONAL MARKETS

MultiPoint Pacing has been proven to elevate cardiac resynchronization therapy (CRT) response.1 Abbott has built on the quadripolar standard of care to offer more pacing options for your patients.

Quadra Allure MP CRT-P allows patients to undergo MRI scans when used with MRI Ready leads from Abbott. This device has been tested for safe performance of an MRI scan using a 1,5 T (Tesla) field-strength MRI scanner.a

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

Quadra Allure MP CRT-P offers the only complete quadripolar system with MultiPoint Pacing and radio frequency (RF) telemetry for remote monitoring of patients. MultiPoint Pacing delivers two left ventricular (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 study4 post-hoc subanalysis (n = 199) 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

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 non-responders 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.3
  • 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
  • SyncAV™ CRT technology automatically adjusts pacing based on real-time changes in a patient's cardiac condition.
MANAGE HEART FAILURE WITH INSIGHTFUL DIAGNOSTICS AND RF MONITORING

Quadra Allure MP CRT-P helps you better manage your patients’ heart failure with intuitive programming options and timely access to their vital heart failure diagnostic data through RF monitoring.

  • CorVue™ congestion monitoring for an earlier insight into HF progression
  • Daily remote monitoring of AT/AF alerts for changes in the patient’s AF condition
  • DirectTrend™ reports for a simplified look at all device data
DESIGNED TO OPTIMIZE TISSUE SELECTION

The Quadra Allure MP CRT-P offers Auto VectSelect Quartet™ Test that:

  • Automatically identifies tissue sites with the latest activation via RV-LV conduction delays measurements
  • Performs threshold testing, assesses LVCap™ Confirm applicability and allows marking of PNS

Pacing at the tissue site of latest activation improves:

  • Acute hemodynamic response12
  • Reverse remodeling13
  • Quality of life13
BUILDING COMPREHENSIVE HEART FAILURE MANAGEMENT

The Quadra Allure MP™ CRT-P 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. See the 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. Tomassoni, G., Baker II, J., Corbisiero, R., Love, C., Martin, D., Sheppard, R., Worley, S., Varma, N., Niazi, I. (2016, May).Safety and efficacy of multipoint pacing in cardiac resynchronization therapy: The MultiPoint Pacing (MPP) IDE Study. Presented at the meeting of the Heart Rhythm Society, San Francisco,CA, LBCT 01-03.
5. Zanon, F., Marcantoni, L., Baracca, E., Pastore, G., Lanza, D., Aggio, A., … Prinzen, F. (2016, April). Acute optimization of left ventricular pacing site plus multipoint pacing improve remodeling and clinical response of CRT at one year follow up. Presented at the meeting of the American College of Cardiology, Chicago, IL, Abstract 1194M-03.
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.
12. Yu, Y., Auricchio, A., Butter, C., Stellbrink, C., Vogt, J., Goehring, A., & Spinelli, J. (2002). Assessment of resynchronization effectiveness of left ventricular lead site. Journal of Cardiac Failure, 8(4S), S72.
13. Gold, M., Birgersdotter-Green, U., Singh J., Ellenbogen, K., Yu, Y., Meyer, T., ... Tchou, P. (2011).The relationship between ventricular electrical delay and left ventricular remodeling with cardiac resynchronization therapy. European Heart Journal, 32(20), 2516-2524. http://dx.doi.org/10.1093/eurheartj/ehr329

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: MPP™ technology demonstrated to be noninferior to biventricular (BiV) with respect to non-responder rate1
Converting Non-Responders to Responders1

The sub-analysis study demonstrated that wider cathode spacing and near-simultaneous intraventricular timing delays are best. When MPP™ 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
  • MPP 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

 

graph showing non-responder is greater than responder
FURTHER STUDIES SHOWING IMPROVEMENTS IN CRT RESPONSE RATE2-4

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

graph showing the responder rates
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
graph showing optimized response proportions

ΔESVi, ΔNYHA, and PACKER’S response rates. Response indicates ΔESVi ≥ 15%, ΔNYHA Class > 0, or PACKER’S score = 0 at follow-up relative to baseline. The vertical segments represent the 95 percent CI of the estimated proportions.

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
graph showing the difference between conv. Bipolar, quadripolar mpp minus, and quadripolar mpp plus
graph showing the difference between conv. Bipolar, quadripolar mpp minus, and quadripolar mpp plus
  • 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
graph showing the response definition between a conventional group and a multi point pacing group
graph showing the response rate between a conventional group and a multi point pacing group
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 Allure MP™ CRT-P 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. Tomassoni, G., Baker II, J., Corbisiero, R., Love, C., Martin, D., Sheppard, R., Worley, S., Varma, N., & Niazi, I. (2016, May). Safety and efficacy of multipoint pacing in cardiac resynchronization therapy: The MultiPoint Pacing (MPP) IDE Study. Presented at the meeting of the Heart Rhythm Society, San Francisco, CA, LBCT 01-03. 

2. Zanon, F., Marcantoni, L., Baracca, E., Pastore, G., Lanza, D., Aggio, A., … Prinzen, F. (2016). 

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 ALLURE MP™

Cardiac Resynchronisation Therapy Pacemaker

Cardiac pulse generator.

ORDERING INFORMATION

 

Reorder Number

Dimensions (H x W x T, mm)

Weight (g)

Volume (cc)

Connector

PM3562

56 x 59 x 6

27

15

IS4-LLL, IS-1

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