CARDIOVASCULAR
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BETTER MANAGEMENT OF HEART FAILURE SYMPTOMS

The innovative Quartet™ quadripolar LV lead is available in four lead shapes, and features four pacing electrodes and up to 14 pacing configurations, enabling left ventricular (LV) pacing at the preferred site without compromising lead stability—giving you a tool to better manage your patients’ heart-failure.

 

Built on the proven QuickFlex™ µ lead platform, the Quartet quadripolar LV lead offers superb deliverability with exceptional stability and performance. Initial studies reflect an implant success rate averaging approximately 97 percent.1,2

INNOVATIVE FEATURES

The Quartet quadripolar LV lead features:

MRI Readiness

The Quartet™ quadripolar LV lead allows full-body, 1.5T MRI scans that meet certain scan conditions.*

  • Meets industry-standard MRI testing requirements
  • Capable of full body 1.5T MRI imaging scans
Options to Match the Patient

The Quartet quadripolar LV lead offers multiple shape and spacing options.

  • Distal shape options include the Double Bend shape, Traditional S-shape, Traditional S-shape--wide spacing and Small S-shape.
  • Total electrode spacing options include the 40, 47 and 60 mm.

 

Quartet Quadripolar LV Lead family
Four Distinctly Spaced Electrodes
  • Enables greater pacing flexibility than unipolar or bipolar leads
  • Provides more options to help you avoid pacing complications
IS4 Connector
  • Enables four pacing electrodes in a single connector for streamlined implantation
Low Profile
  • 4.7 F lead body diameter for maneuverability
  • 4.0 F tip electrode, which aids access to small targets or difficult-to-reach branch veins
Steerable Tip
  • Adjustable distal tip angle for enhanced maneuverability in venous anatomy
Optim™ Lead Insulation
  • A hybrid insulation material—the first of its kind
  • Developed specifically for cardiac lead use
  • Blends the biostability and flexibility of high-performance silicone rubber with the strength, tear resistance and abrasion resistance of polyurethane, allowing for superior abrasion resistance in a thin diameter lead3
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)

REIMBURSEMENT INFORMATION

REFERENCES

*See MRI Ready Systems Manual for device and lead combinations and associated MRI scan parameters. Quartet™ quadripolar LV Lead is MR Conditional in the 86cm lead length.
1. 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), 365-3

2. 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
3. Jenney, C., Tan, J., Karicherla, A., Burke, J., & Helland, J. (2005). A new insulation material for cardiac leads with potential for improved performance. Heart Rhythm, 2(5), S318-319. http://dx.doi.org/10.1016/j.hrthm.2005.02.1004

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.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 exposure3,4
  • 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.

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 leads3,4
    • 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
a chart showing lower rates of deactivation and device replacement
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

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

Left-heart lead

ORDERING INFORMATION

 

Reorder Number

Shape

Electrode Spacing (mm)

Insulation

1458Q/75

Traditional S

47

Optim™

1458Q/86

Traditional S

47

Optim™

1458Q/92

Traditional S

47

Optim™

1456Q/75

Small-S

40

Optim™

1456Q/86

Small-S

40

Optim™

1457Q/75

Double Bend

47

Optim™

1457Q/86

Double Bend

47

Optim™

1458QL/75

Traditional S

60

Optim™

1458QL/86

Traditional S

60

Optim™

SEE FULL PRODUCT DETAILS  and any references for this product.

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INDICATIONS, SAFETY & WARNINGS

Quartet™

Family of LV Leads

Rx Only

Brief Summary: Prior to using these devices, please review the User’s Manual for

a complete listing of indications, contraindications, warnings, precautions, potential
adverse events and directions for use.

Indications and Usage: The Quartet lead has application as part of a St. Jude Medical™ biventricular system.

Contraindications: The use of the Quartet lead is contraindicated in patients who:

  • Are expected to be hypersensitive to a single dose of 1.0 mg of dexamethasone sodium phosphate.
  • Are unable to undergo an emergency thoracotomy procedure.
  • Have coronary venous vasculature that is inadequate for lead placement, as indicated by venogram.

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INDICATIONS, SAFETY & WARNINGS

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