Clinicaltrials.gov Identifier: NCT00990665
Postoperative Performance of the Quartet® Left Ventricular Heart Lead
Version of Record online: 22 JAN 2013
© 2013 Wiley Periodicals, Inc.
Journal of Cardiovascular Electrophysiology
Volume 24, Issue 4, pages 449–456, April 2013
How to Cite
TOMASSONI, G., BAKER, J., CORBISIERO, R., LOVE, C., MARTIN, D., NIAZI, I., SHEPPARD, R., WORLEY, S., BEAU, S., GREER, G. S., ARYANA, A., CAO, M., HARBERT, N., ZHANG, S. and for the Promote® Q CRT-D and Quartet® Left Ventricular Heart Lead Study Group (2013), Postoperative Performance of the Quartet® Left Ventricular Heart Lead. Journal of Cardiovascular Electrophysiology, 24: 449–456. doi: 10.1111/jce.12065
This study was supported by St. Jude Medical, Sylmar, CA, USA.
The following authors served as consultants for St. Jude Medical: G. Tomassoni, J. Baker, R. Corbisiero, C. Love, D. Martin, I. Niazi, R. Sheppard, S. Worley, S. Beau, A. Aryana.
In addition, G. Tomassoni received speaker's board compensation from St. Jude Medical and served as consultant/advisory board to Medtronic and Boston Scientific; D. Martin served as a consultant for Biotronik; I. Niazi served as a consultant for Sanofi Winthrop and Osptey Medical and received research grants from St. Jude Medical, Medtronic, and Boston Scientific; S. Worley received speaker's bureau compensation relevant to this topic. N. Harbert and S. Zhang are employees of St. Jude Medical.
S. Greer and M. Cao: No disclosures.
- Issue online: 1 APR 2013
- Version of Record online: 22 JAN 2013
- Manuscript received 27 July 2012; Revised manuscript received 21 October 2012; Accepted for publication 12 November 2012.
- cardiac resynchronization therapy;
- heart failure;
- implantable cardioverter defibrillator;
- phrenic nerve stimulation;
- quadripolar LV pacing lead
Promote® Q CRT-D and Quartet® LV Lead Study. Introduction: The Quartet® left ventricular (LV) lead is the first with 4 pacing electrodes (tip and 3 rings) that enables pacing from 10 different pacing vectors. Postoperative performance of this lead was evaluated in a prospective, nonrandomized, multicenter IDE study.
Methods: Patients with standard indications for CRT-D were enrolled. Electrical performance and presence of phrenic nerve stimulation (PNS) were assessed during pacing from each of 10 vectors at predischarge (within 7 days), 1 month, and 3 months postimplant.
Results: The Quartet LV lead was implanted successfully in 170 patients (95.5% implant success rate, 68 ± 11 years, 68.5% male, LVEF: 25 ± 7%, NYHA class III: 98.3% and class IV: 1.7%). Mean follow-up was 4.7 ± 1.9 months. Capture threshold and impedance for each of the 10 LV lead pacing vectors remained stable during follow-up. LV lead dislodgement occurred in 6 (3.5%) patients and PNS was observed in 23 (13.5%) patients. PNS was resolved noninvasively in all 23 (100%) patients, either by reprogramming to pace from the additional LV lead pacing vectors alone (13 pts, 56.5%), reprogramming to pace from the additional LV lead pacing vectors and reprogramming pacing output (4 pts, 17.4%), or by reprogramming pacing output alone (6 pts, 26.1%).
Conclusions: The Quartet LV lead electrical performance was stable and was associated with a high implant success and low dislodgement rate during 3-month follow-up. In all patients with PNS, the 10 pacing vectors combined with reduced output programming enabled the elimination of PNS noninvasively. (J Cardiovasc Electrophysiol, Vol. 24, pp. 449-456, April 2013)