Performance of a novel left ventricular lead with short bipolar spacing for cardiac resynchronization therapy: primary results of the Attain Performa quadripolar left ventricular lead study
George H Crossley, Mauro Biffi, Ben Johnson, Albert Lin, Daniel Gras, Azlan Hussin, Allen Cuffio, Jack L Collier, Mikhael El-Chami, Shelby Li, Keith Holloman, Derek V Exner, George H Crossley, Mauro Biffi, Ben Johnson, Albert Lin, Daniel Gras, Azlan Hussin, Allen Cuffio, Jack L Collier, Mikhael El-Chami, Shelby Li, Keith Holloman, Derek V Exner
Abstract
Background: The Medtronic Attain Performa quadripolar leads provide 16 pacing vectors with steroid on every electrode. This includes a short bipolar configuration between the middle 2 electrodes.
Objective: A prospective clinical study was conducted to investigate the safety and effectiveness of these new leads in 27 countries.
Methods: Cardiac resynchronization therapy with defibrillator candidates were enrolled (mean age 68 years; 71% men). All implanted subjects were followed at 1, 3, and 6 months postimplant. Pacing capture threshold (PCT) values were measured at each visit. Adverse events were reported upon occurrence.
Results: Of 1124 subjects in whom a left ventricular (LV) lead was attempted, 1097 (97.6%) were successfully implanted with an Attain Performa lead. Thirty-six LV lead-related complications were reported (the 6-month LV lead-related complication-free survival rate was 96.9%). Phrenic nerve stimulation (PNS) occurred in 81 subjects (7.2%), with only 3 (0.3%) requiring surgical intervention. At 6 months, the mean PCT at the programmed vector was (1.1 ± 0.8) V and 94.4% of subjects had a PCT of ≤2.5 V. All 16 programming polarities were used in at least 1 patient, and short bipolar configurations were used in 17% of subjects.
Conclusion: This large multicenter study demonstrated a high success rate for the implantation of Attain Performa quadripolar LV leads with a low complication rate. The PCT was low and stable over time. A low rate of postimplantation PNS was observed, and cases of PNS were readily resolved with reprogramming. Nonstandard vectors were often used for LV pacing.
Keywords: Cardiac resynchronization therapy; Congestive heart failure; Defibrillator; Quadripolar lead.
Copyright © 2015 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.
Source: PubMed