Performance of a novel active fixation quadripolar left ventricular lead for cardiac resynchronization therapy: Attain Stability Quad Clinical Study results

Abstract

Introduction: The Medtronic Attain Stability Quad lead is a quadripolar left ventricular (LV) lead with an active fixation helix assembly designed to fixate the lead within the coronary sinus and pace nonapical regions of the LV. The primary objective of this study was to determine the safety and effectiveness of this novel active fixation quadripolar LV lead.Methods: Patients with standard indications for cardiac resynchronization therapy (CRT) were enrolled. All patients were followed at 3 and 6 months post-implant and every 6 months thereafter until study closure. Pacing capture thresholds (PCTs) were measured at implant and each follow-up and adverse events (AEs) were recorded upon occurrence.Results: Of the 440 patients who underwent implant procedures, placement of the Attain Stability Quad lead was successful in 426 (96.8%). LV lead-related complications occurred in 10 patients (2.3%), including LV lead dislodgement in three patients (0.7%). The percentage of patients with at least one LV pacing vector with a PCT ≤2.5 V at a 6-month follow-up was 96.3%. The LV lead was successfully fixated to the prespecified pacing location in 97.4% of cases.Conclusions: This large, multinational study of the Attain Stability Quad lead demonstrated a high rate of implant success with a low complication rate. The active fixation mechanism allowed precise placement of the pacing electrodes at the desired target region with good PCTs and a very low dislodgement rate. K E Y W O R D S active fixation, cardiac resynchronization therapy, lead dislodgement, LV lead, quadripolar lead 1148 | JACKSON ET AL.

The usefulness of balloon occlusive left ventricular lead delivery in combination with the quadripolar active fixation lead for a patient with complex coronary venous morphology

“…The Attain Stability Quad Clinical Study results also reported a high success rate of LV lead placement (96.8%) with a low dislodgement rate (0.7%). Furthermore, the success rate of placement in the prespecified target pacing location was 97%, and in 90.6% of them, a tip electrode was located in the non-apical region [6]. In the present case, the peripheral venous diameter of the lateral vein was sufficient for lead placement; however, pacing from the apical region was unavoidable when a conventional LV lead was used.…”

Novel lead-anchor technique using an active fixation quadripolar left ventricular lead in cardiac resynchronization therapy

“…8 The Medtronic Attain Stability Quad lead, which combines an active fixation mechanism with a quadripolar lead, allows for a targeted approach to LV pacing. 3,9,10 Using an active fixation lead allows for better stability in the veins, which often have large diameters, compared with a passive fixation lead, the stability of which concerns operators. 11 It is also important to develop a technique to advance an LV lead through target vessels and to overcome lead stability issues.…”

Performance of an active fixation bipolar left ventricular lead vs passive fixation quadripolar leads in cardiac resynchronization therapy, a randomized trial

“…The new location of the fixation helix between electrodes 3 and 4 in the Medtronic lead model 4798 may potentially further augment the stability of the active fixation lead. 18 There is an obvious concern about the extractability of active fixation LV lead. Unlike the leads with side lobes of the lead, the Attain Stability is fixated with a side helix constructed to uncoil in response to retractive force.…”

“…The present trial did not prove that adding an active fixation mechanism to bipolar lead makes them more stable than passive fixation quadripolar leads. The new location of the fixation helix between electrodes 3 and 4 in the Medtronic lead model 4798 may potentially further augment the stability of the active fixation lead 18 . There is an obvious concern about the extractability of active fixation LV lead.…”