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.

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.