Abstract 14753: A Novel Quadripolar Lead with a Narrow-Spaced Bipole Allows for Effective LV Pacing While Avoiding Phrenic Nerve Stimulation - Attain Performa LV Lead Study Primary Results

Abstract

Introduction: The Medtronic Attain Performa™ Model 4298 Quadripolar left ventricular (LV) Lead has 4 electrodes, provides 16 different polarities & includes a short bipole (1.3 mm between 2nd & 3rd electrodes). A prospective clinical study was conducted to investigate the safety and effectiveness of this new lead in 20 countries worldwide. Methods: Cardiac resynchronization therapy defibrillator (CRT-D) patients were enrolled & implanted with the Model 4298 LV lead & a Quad CRT-D device. All implanted subjects(SUB) were followed at 1, 3, 6 and every 6 months (M) post-implant. Pacing capture thresholds (PCTs) were measured manually or with automated testing methods. Adverse events (AEs) were reported upon occurrence & reviewed by an independent committee. Events requiring invasive intervention or resulting loss of CRT were considered to be complications. Results: Of 499 SUB (68 + 11 yr, 71% male) who underwent an LV lead implant attempt, 487 (97.6%) had an LV lead implanted, Most (73%) had NYHA Class III or IV symptoms, average LV ejection fraction was 25 ± 7%, QRS duration was 155 ± 24ms & most (71%) had LBBB. There were 20 LV lead related complications in 19 SUB over 6M (LV lead related complication free survival rate = 96%). Phrenic nerve stimulation (PNS) occurred in 31 SUB (6.3%) & resolved with no treatment (N=1) or noninvasive reprogramming (N=29). The average PCT at 6M was 1.1 + 0.7 V at the programmed vector and 93.9% of SUB had a PCT≤ 2.5V. The vast majority (97.7%) of SUB had > 1 additional selectable pacing vector with a PCT ≤ 4V and no PNS. Non-standard pacing polarities (i.e., vectors other than LV1 [LV tip] to right ventricular coil [RVC], LV2 to RVC & LV1 to LV2) were utilized in 56% of SUB. LV1 was not used in the final vector in 46% of SUB. The LV1 to RVC was utilized in 19%, LV1 to LV2 in 18% & the short bipole (LV2 to LV3) in 12%. Conclusions: This large multicenter study demonstrated that implantation of the Model 4298 LV quadripolar lead is associated with a low complication rate and no unanticipated complications. PNS can be readily resolved with reprogramming & that PCT values are low & stable over time. Moreover, At least 1 back-up LV pacing vector was available in the vast majority of SUB. Non-standard vectors, including the short bipole (LV2-LV3) were used in 56% of subjects.