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Clinical Evidence

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™ LV 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 LV 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 leads4
    • 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 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 nerve stimulation (PNS)8

and surgical lead revisions9

Improved outcomes

22% 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
Lower rates of deactiviation and replacement twelve months post-implant for the Quartet LV lead compared to Bipolar technology.

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 a 22% relative reduction in mortality compared with a bipolar LV system.10

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 Quartet™ 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. https://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). https://insights.ovid.com/europ/201106003/00127069-201106003-00153
  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. https://insights.ovid.com/europ/201106003/00127069-201106003-00148
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