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).

MultiPoint Pacing technology is designed to deliver multiple independent left ventricular (LV) pacing pulses from a single quadripolar lead to provide you with CRT options to change:

  • Pattern of depolarization
  • Engagement of areas around scar tissue
  • Hemodynamics
  • Resynchronization

Using the Quadra Allure MP™ CRT-P with Quartet™ quadripolar LV pacing lead, with its four pacing electrodes and 14 pacing vectors, provides more options and greater control in CRT response.

U.S. IDE STUDY: IMPORTANCE OF MPP™ TECHNOLOGY PROGRAMMING1

The recent IDE study1 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).1

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

ADDITIONAL INTERNATIONAL CLINICAL DATA

This evidence builds on our quadripolar standard of care, which has offered you more options to pace at the preferred LV site, resulting in:

  • Improved CRT outcome2,3
  • Fewer surgical revisions4
  • Reduced need for lead repositioning at implant, leading to shorter procedure times and decreased fluoroscopic exposure5,6
  • More basal pacing opportunities without compromising lead stability7,8
QUADRA ALLURE MP CRT-P ADVANCED FEATURES AND BENEFITS
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 response9
  • Reverse remodeling10
  • Quality of life10
Enhanced Programming Options
  • SyncAV™ CRT technology automatically adjusts pacing based on real-time changes in a patient's cardiac condition.
Providing 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 radio frequency (RF) monitoring, providing:

  • 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
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. Forleo,. G. B., Mantica, M., Di Biase, L., Panattoni, G., Della Rocca, D. G., Papavasileiou, L. P., … Romeo, F. (2012). Clinical and procedural outcome of patients implanted with a quadripolar left ventricular lead: Early results of a prospective multicenter study. Heart Rhythm, 9(11), 1822-1828. http://dx.doi.org/10.1016/j.hrthm.2012.07.012
3. Turakhia, M., Cao, M., Fischer, A., Arnold, E. M., Sloman, L. S., Dalal, N., & Gold, M. (2014, June). Reduced mortality with quadripolar compared to bipolar left ventricular leads in cardiac resynchronization therapy. Presented at the World Congress in Cardiac Electrophysiology and Cardiac Techniques, Nice, France. Retrospective analysis; not prespecified.
4. Forleo, G. B., Della Rocca, D. G., Papavasileiou, L. P., Molfetta, A. D., Santini, L., & Romeo, F. (2011). Left ventricular pacing with a new quadripolar transvenous lead for CRT: Early results of a prospective comparison with conventional implant outcomes. Heart Rhythm, 8(1), 31-37. http://dx.doi.org/10.1016/j.hrthm.2010.09.076
5. Dänschel, W., Sperzel, J. K., Gutleben, K., Kranig, W., Mortensen, P., Connelly, D., … Hallier, B. (2010). Initial clinical experience with a novel left ventricular quadripolar lead. Europace, 12(Suppl. 1), i127. http://dx.doi.org/10.1093/europace/euq127
6. Duray, G. Z., Hohnloser, S. H., Israel, C. W. (2008). Coronary sinus side branches for cardiac resynchronization therapy: prospective evaluation of availability, implant success, and procedural determinants. Journal of Cardiovascular Electrophysiology, 19(5), 489-494. http://dx.doi.org/10.1111/j.1540-8167.2007.01096.x
7. Merchant, F. M., Heist, E. K., McCarty, D., Kumar, P., Das, S., Blendea, D., … Singh, J. P. (2010). Impact of segmental left ventricular lead position on cardiac resynchronization therapy outcomes. Heart Rhythm, 7(5), 639-644. http://dx.doi.org/10.1016/j.htrhtm.2010.01.035
8. Singh, J. P., Klein, H. U., Huang, D. T., Reek, S., Kuniss, M., Quesada, A., … Moss, A. J. (2011). Left ventricular lead position and clinical outcome in the Multicenter Automatic Defibrillator Implantation Trial Cardiac Resynchronization Therapy (MADIT-CRT) trial. Circulation, 123(11), 1159-1166. http://dx.doi.org/10.1161/CIRCULATIONAHA.110.000646
9. 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.
10. 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 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 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
MULTIPOINT PACING DATA FROM INTERNATIONAL STUDIES

Several international studies report results related to improved patient response to CRT with MultiPoint Pacing as compared to single-site pacing.

Reported Improvements of CRT Response Rate At 12 Months2

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 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.

Reported Improvements in Ejection Fraction at 6 Months3

Forleo et al. compared the changes in ejection fraction (EF) in 232 patients with a 6-month follow-up.During implant, capture thresholds were measured as well as the presence of PNS. The results show:

  • MPP technology was programmable in 97% of patients3 
  • 56% clinical composite score for patients with MPP technology turned on versus 38% in control group3
  • 39% ± 9.6% increase from 28.2% ± 509 in left ventricular EF for patients with MPP technology turned on3
  • 34.6% ± 7.6% increase from 28.1% ± 6.0 in patients with MPP technology turned off3
graph showing changes in mean left ventricular ejection fraction

In summary, the Italian MPP technology registry (IRON-MPP) study showed QRS was reduced and both EF and clinical composite score improved with MPP technology relative to conventional BiV.3

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). Optimization of left ventricular pacing site plus multipoint pacing improves remodeling and clinical response of cardiac resynchronization therapy at 1 year. Heart Rhythm, 13(8),1644-1651. http://dx.doi.org/10.1016/j.hrthm.2016.05.015
3. Forleo, G. B., Santini, L., Giammaria, M., Potenza, D., Curnis, A., Calabrese, V., … Zanon, F. (2016). Multipoint Pacing via a quadripolar left-ventricular lead: Preliminary results from the Italian registry on multipoint left-ventricular pacing in cardiac resynchronization therapy (IRON-MPP). Europace, (17 May 2016), 1-8. http://dx.doi.org/10.1093/europace/euw094

OUR PRODUCTS

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INDICATIONS, SAFETY & WARNINGS

INDICATIONS, SAFETY & WARNINGS

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Brief Summary: Prior to using these devices, please review the Instructions for Use for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use. Devices depicted may not be available in all countries. Check with your Abbott representative for product availability in your country.

Indications: Implantation of Quadra Allure MP RF device is indicated for: maintaining synchrony of the left and right ventricles in patients who have undergone an AV nodal ablation for chronic atrial fibrillation and have NYHA Class II or III heart failure, the reduction of the symptoms of moderate to severe heart failure (NYHA Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy, and have a left ventricular ejection fraction ≤ 35% and a prolonged QRS duration, implantation of Assurity™, Endurity™ and Allure™ family of devices is indicated in one or more of the following permanent conditions: syncope, presyncope, fatigue, disorientation, or any combination of those symptoms.

Rate-Modulated Pacing is indicated for patients with chronotropic incompetence, and for those who would benefit from increased stimulation rates concurrent with physical activity. Dual-Chamber Pacing is indicated for those patients exhibiting: sick sinus syndrome, chronic, symptomatic second- and third-degree AV block, recurrent Adams-Stokes syndrome, symptomatic bilateral bundle branch block when tachyarrhythmia and other causes have been ruled out. Atrial Pacing is indicated for patients with sinus node dysfunction and normal AV and intraventricular conduction systems. Ventricular Pacing is indicated for patients with significant bradycardia and normal sinus rhythm with only rare episodes of A-V block or sinus arrest, chronic atrial fibrillation, severe physical disability. AF Suppression™ algorithm is indicated for suppression of paroxysmal or persistent atrial fibrillation episodes in patients with one or more of the above pacing indications. 

Contraindications: Implanted Cardioverter-Defibrillator (ICD). Devices are contraindicated in patients with an implanted cardioverter-defibrillator. Rate-Adaptive Pacing may be inappropriate for patients who experience angina or other symptoms of myocardial dysfunction at higher sensor-driven rates. An appropriate Maximum Sensor Rate should be selected based on assessment of the highest stimulation rate tolerated by the patient. AF Suppression stimulation is not recommended in patients who cannot tolerate high atrial-rate stimulation. Dual-Chamber Pacing, though not contraindicated for patients with chronic atrial flutter, chronic atrial fibrillation, or silent atria, may provide no benefit beyond that of single-chamber pacing in such patients. Single-Chamber Ventricular Demand Pacing is relatively contraindicated in patients who have demonstrated pacemaker syndrome, have retrograde VA conduction, or suffer a drop in arterial blood pressure with the onset of ventricular pacing. Single-Chamber Atrial Pacing is relatively contraindicated in patients who have demonstrated compromise of AV conduction. Atrial Fibrillation. Allure™ devices are contraindicated in patients having chronic atrial fibrillation or intermittent atrial fibrillation that does not terminate. For specific contraindications associated with individual modes, refer to the programmer’s on-screen help. 

Potential Adverse Events: The following are potential complications associated with the use of any pacing system: air embolism, body rejection phenomena, cardiac tamponade or perforation, hematoma, bleeding hematoma, seroma, formation of fibrotic tissue, local tissue reaction, inability to interrogate or program due to programmer or device malfunction, infection/erosion, interruption of desired pulse generator function due to electrical interference, either electromyogenic or electromagnetic, lead malfunction due to conductor fracture or insulation degradation, loss of capture or sensing due to lead dislodgement or reaction at the electrode/ tissue interface, loss of desired pacing and/or sensing due to lead displacement, body reaction at electrode interface, or lead malfunction (fracture or damage to insulation), loss of normal device function due to battery failure or component malfunction, pacemaker migration or pocket erosion, pectoral muscle or diaphragmatic stimulation, phrenic nerve stimulation, pneumothorax/hemothorax, endocarditis, excessive bleeding, induced atrial or ventricular arrhythmias, myocardial irritability, pericardial effusion, pericardial rub, pulmonary edema, rise in threshold and exit block, valve damage, cardiac/coronary sinus dissection, cardiac/coronary sinus perforation, coronary sinus or cardiac vein thrombosis. 

Refer to the User’s Manual for detailed indications, contraindications, warnings, precautions and potential adverse events.

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