QUADRA ALLURE MP™ CRT-P

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

FURTHER STUDIES SHOWING IMPROVEMENTS IN CRT RESPONSE RATE^2-4

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

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

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

• 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

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 Hemodynamic^8,9 and Acute Hemodynamic Response^6,10

• 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

Product Manuals (Instructions for Use)

Multipoint™ Pacing Clinical Compendium

More Options For Heart Failure Patients: CRT Portfolio Flyer

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