REVOLUTIONIZING CARDIAC RESYNCHRONIZATION THERAPY PACING

Abbott is dedicated to the development of therapies and technologies that reimagine the treatment of epidemic disease—and our cardiac resynchronization therapy (CRT) pacing devices are no exception. We have developed a unique suite of tools based on innovative quadripolar technology that have the potential to revolutionize the care of heart failure (HF) patients.

CRT AND QUADRIPOLAR TECHNOLOGY

We designed our groundbreaking quadripolar technology to enable improved management and outcomes for HF patients. With four electrodes and 10 pacing configurations, the quadripolar system enables left ventricular (LV) pacing at the preferred site without compromising lead stability, for better management of heart failure patients.¹

HF patients who undergo implantation of unipolar and bipolar CRT-D devices may experience challenges such as phrenic nerve stimulation, high pacing thresholds and non-response to CRT therapy.² Managing these challenges can result in longer implant times and surgical revisions.

Quadripolar technology can help you overcome these challenges by offering you more pacing flexibility without compromising lead stability. Potential benefits include:

• Shorter implant times and decreased fluoroscopic exposure^3,4
• Fewer surgical revisions⁵
• More basal pacing opportunities (pacing basally has been shown to be associated with improved outcomes)^6,7

Overall, quadripolar technology can lead to greater CRT implant and postoperative efficiencies while providing improved CRT efficacy.

BUILDING COMPREHENSIVE HEART FAILURE MANAGEMENT

The Quartet™ quadripolar LV lead is part of our heart failure management portfolio. Our vision is to transform the treatment of heart failures 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)

REFERENCES

1. Data compiled from clinical study results, on file at St. Jude Medical in Report 60034670.
2. Thibault, B., Dubuc, M., Guerra, P. G., Karst, E., Ryu, K., Paiement, P., … Farazi, T. (2011). Electrode selection to avoid phrenic stimulation with a quadripolar left heart lead. Heart Rhythm, 8(5), S68. http://dx.doi.org/10.1016/j.hrthm.2011.03.023
3. Sperzel, J., Dänschel, W., Gutleben, K. J., Kranig, W., Mortensen, P., Connelly, D., … Rinaldi, C. A. (2012). First prospective, multi-centre clinical experience with a novel left ventricular quadripolar lead. Europace, 14(3), 365-372. http://dx.doi.org/10.1093/europace/eur322
4. 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
5. 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
6. Singh, J. P., Klein, H. U., Huang, D. T., Reek, S., Kuniaa, 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
7. Merchant, F. M., Heist, E. K., McCarty, D., Kumar, P., Das, S., Blendea, D., … Singh, J. P. (2010). Impact of segmental left ventricle lead position on cardiac resynchronization therapy outcomes. Heart Rhythm, 7(5), 639-644. http://dx.doi.org/10.1016/j.hrthm.2010.01.035

QUADRIPOLAR ADVANTAGES FOR CARDIAC RESYNCHRONIZATION THERAPY

Cardiac resynchronization therapy (CRT) is an effective treatment for heart failure, and it can help your patients avoid life-threatening changes in heart rhythm. CRT can also alleviate many of the symptoms experienced by your patients, improving their overall quality of life.

Quadripolar technology offers a significant advantage over bipolar technology—giving you the flexibility you need to access pacing sites and vectors outside of the reach of most devices, without compromising lead stability or performance.

QUARTET™ LV LEAD PROVIDES EXCELLENT OUTCOMES

When used in conjunction with our innovative suite of quadripolar technology-enabled CRT solutions, the Quartet™ lead supports improved patient outcomes.

• After 18 months, 97.4% of patients were successfully implanted with the quadripolar system; once placed, the LV lead remained stable with excellent pacing thresholds during follow-up (15 ± 5 months)¹
• The Quartet lead was used to address phrenic nerve stimulation (PNS) noninvasively in 100% of cases²
• Use of quadripolar pacing technology resulted in:
  • Lower risk of lead deactivation or replacement than bipolar leads, as well as lower capture thresholds in comparison to unipolar or bipolar leads^3,4
  • Significantly lower capture thresholds in comparison to unipolar or bipolar leads³
  • Very low dislodgment rates³
• Among patients with high capture thresholds, the use of a quadripolar lead has extended battery life by up to 17 months⁴

REDUCES PATIENT AND HOSPITAL COSTS

Cost analysis performed on a single-center registry showed that the Quartet quadripolar LV lead was associated with significantly reduced hospitalizations, specific to heart failure (HF) and left ventricular (LV) lead surgical revision.⁵

Study Results

• In-patient heart failure hospitalization rates and LV lead surgical revisions were 54% lower for the quadripolar group (0.15/patient-year than for the bipolar LV group (0.32/patient-year) (p = 0.04).⁵
• The hospitalization rate reduction was accompanied with statistically significant cost savings of 62% (p = 0.016).⁵

BENEFITS OF QUADRIPOLAR TECHNOLOGY

The use of quadripolar technology offers you and your hospital or clinic many clinical, economic and operational advantages, over bipolar technology, including:

Reduced cost

• 39.8% reduction in Heart Failure hospitalization cost⁶
• 54% lower hospitalization rate⁵
• Overall cost savings (effective resource utilization)⁷
• 32.1% reduction of 30 day readmission rate⁶
• Reduction in phrenic nerves stimulation (PNS)⁸ and surgical lead revisions⁹

Improved outcomes

• 18% relative reduction in all-cause mortality¹⁰
• Increase in dP/dt with biventricular (BiV) pacing at site of late activation¹¹
• Improved hemodynamics¹²

Operational efficiency, implant success and lead performance

In clinical studies, quadripolar pacing technology has resulted in:

• Significantly lower risk of lead deactivation or replacement than bipolar leads³

OUR QUADRIPOLAR CRT SYSTEM IS ASSOCIATED WITH INCREASED SURVIVAL

Patients with a quadripolar system may receive more effective CRT than those with bipolar LV pacing:⁴

Mortality results

Mortality incidence was significantly lower in the quadripolar group.¹⁰

• Quadripolar: 5.04 deaths per 100 patient-years
• Bipolar: 6.45 deaths per 100 patient-years (p = 0.001)

After multivariate adjustment, the quadripolar lead was associated with a lower risk of death HR: 0.77; 95% CI: 0.69 to 0.86; p < 0.001.¹⁰

MORTALITY CONCLUSIONS

CRT with quadripolar LV system was associated with an 18% relative reduction in mortality compared with a bipolar LV system.¹⁰

BUILDING COMPREHENSIVE HEART FAILURE MANAGEMENT

The Quartet™ quadripolar LV lead is part of our heart failure portfolio. Our vision is to transform the treatment of heart failures by designing technology that delivers excellent clinical outcomes and improves workflow and efficiency. Read more about the portfolio and our approach to heart failure management.

RESOURCES AND DOCUMENTATION

Product Manuals (Instructions for Use)

REFERENCES

1. 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.2012.07.021
2. Tomassoni, G. Baker, J., Corbisiero, R., Love, C., Martin, D., Niazi, I., … Zhang, Z. (2013). Post-operative performance of the Quatet™ Left Ventriocular Heart Lead. J Cardiovasc Electrophysiol 24(4). 449-456. https://dx.doi.org/10.1111/jce.12065
3. Turakhia, M. P., Gold, M. R., Fischer, A., Sloman, L. S., Kumar, C., Dalal, N., … Cao, M., (2013). Decreased rate of left ventricular lead deactivation and replacement associated with use of quadripolar LV leads. Europace, 15(Suppl. 2), S47. http://dx.doi.org/10.1093/europace/eut169
4. Manyam, H., Bhimani, A. A., Sadrpour, S. A., De Oliveira, S. A., Goldstein, R., N., Cakulev, I., … Mackall, J. (2013). Quadripolar left ventricular leads yield lower capture thresholds with expected increase in battery longevity. Heart Rhythm, 10(5) S228. http://dx.doi.org/10.1016/j.hrthm.2013.03.019
5. Forleo, G. B., Di Biase, L., Bharmi, R., Dalal, N., Panattoni, G., Pollastrelli, A., … Romeo, G. (2015). Hospitalization rates and associated cost analysis of cardiac resynchronization therapy with an implantable defibrillator and quadripolar vs. bipolar left ventricular leads: a comparative effectiveness study. Europace, 17(1), 101-107. http://dx.doi.org/10.1093/europace/euu290
6.Corbisiero, R., Kazemian, P., Bharmi, R., Shar, R., Muller, D. (2016). Less with More: Hospitalization cost and Event Rates with Quadripolar versus Bipolar CRT-D. PACE 39(10). 1038-1045. https://dx.doi.org/10.1111/pace.12923
7. Graham, C. M., Gayle, J., & Magee, G. (2014, May). Comparison of healthcare utilization and hospital costs for quadripolar versus bipolar LV lead technologies. Presented at the meeting of the Heart Rhythm Society, San Francisco, CA.
8. Mehta, P. A., Shetty, A. K., Squirrel, M., Bostock, J., & Rinaldi, C. A. (2012). Elimination of phrenic nerve stimulation occurring during CRT: Follow-up in patients implanted with a novel quadripolar pacing lead. Journal of Interventional Cardiac Electrophysiology, 33(1), 43-49. http://dx.doi.org/ 10.1007/s10840-011-9598-5
9. Viani, S. M., Segreti, L., Di Cori, A., Zucchelli, G., Paperinin, L., Soldati, E., … Bongiorni, M. G. (2011).  A new quadripolar lead for left ventricular pacing: Short term reliability and future opportunities. Europace, 13(Suppl. 3). http://dx.doi.org/10.1093/europace/eur220
10. Turakhia, M., Cao, M., Fischer, A., Nabutovsky, Y., Sloman, L. S., Dalal, Nirav., Gold, M. R. (2018). Reduced mortality associated with quadripolar compared to bipolar left ventricular leads in cardiac resynchronization therapy. J Am Coll Cardiol EP. 2(4). 426-33. https://dx.doi.org/10.1016/j.jacep.2016.02.007
11. Pappone, C., et al. (2012, October). Left ventricular pacing from a site of late electrical activation improves acute hemodynamic response to cardiac resynchronization therapy. Presented at the meeting of the Asia Pacific Heart Rhythm Society, Taipei, Taiwan.
12. Gutleben, K. J., Kranig, W., Barr, C., Morgenstern, M. M., Simon, M., & Dalal, Y. H. (2011). LV-pacing: Vector optimization using a novel quadripolar electrode acutely improves cardiac output in cardiac resynchronization therapy patients. Europace, 13(3), P403. http://dx.doi.org/10.1093/europace/eur220

QUARTET™ FAMILY OF LV LEADS

TECNICAL SPECIFICATIONS