Key result
Novel 4Fr active-fixation LV lead demonstrates ~97% implantation success with no subsequent dislodgements.
Why the study?
Does a novel 4Fr LV lead with a side helix for active fixation provide stable and targeted placement in patients undergoing cardiac resynchronization therapy?
Observational (n=106)
Does a novel 4Fr LV lead with a side helix for active fixation provide stable and targeted placement in patients undergoing cardiac resynchronization therapy?
A novel 4Fr LV lead with active fixation via a side helix allows for precise, stable placement with low pacing thresholds and no late dislodgements in CRT patients.
Facilitates targeted LV lead placement with stability in CRT; leaves open outcome benefits versus standard leads.
AIMS: Suboptimal placement, phrenic nerve stimulation, and dislodgements of left-ventricular (LV) leads are main challenges in cardiac resynchronization therapy. We investigated the handling, performance, safety, and stability for a novel 4Fr LV lead with a small side helix located proximal to the ring electrode for active fixation of the LV lead. METHODS AND RESULTS: The novel LV lead was successfully implanted in 103 of 106 patients. Patients with dislodged LV leads and with demanding coronary vein anatomies were included. The lead body was rotated clockwise to engage the active fixation side helix in the vein wall. The stimulating electrode was located in basal LV segment and middle LV segment in 54 and 46% of the patients, respectively. The lead was targeted to a vein concordant to the LV segment with latest mechanical activation. Concordant LV lead placement was achieved in 73% of the patients and in adjacent segment in 24%. The average pacing capture threshold (PCT) at implantation was 1.04 ± 0.6 V (n = 103) and at an average follow-up at 7 months, the PCT remained low and no dislodgements have been observed. During follow-up, four leads have been explanted without complications. CONCLUSION: Active fixation of this 4Fr LV lead by using a side helix, offers flexibility to place the lead precisely in targeted vein segments over a wide range of vein anatomies. The average LV pacing threshold was low at implantation and follow-ups. The lead seems to be extractable and no late dislodgements have been observed.
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Keilegavlen et al. (2015) conducted an observational in Cardiac resynchronization therapy (n=106). Novel 4Fr LV lead with a small side helix was evaluated on Successful implantation.
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