Key result
Bipolar active fixation leads are linked to similar CRT response vs quadripolar but 0% phrenic nerve stimulation.
Why the study?
Bipolar active fixation and quadripolar passive fixation left-ventricular leads were designed to reduce phrenic nerve stimulation and lead dislodgment, but long-term safety and performance comparisons are needed.
Does a bipolar active fixation left-ventricular lead improve long-term safety and performance compared to a quadripolar passive fixation lead in patients receiving cardiac resynchronization therapy?
Cohort (n=81)
No
Does a bipolar active fixation left-ventricular lead improve long-term safety and performance compared to a quadripolar passive fixation lead in patients receiving cardiac resynchronization therapy?
Absolute Event Rate: 61.1% vs 60%
p-value: p=0.82
Bipolar active fixation leads offer comparable clinical outcomes and electrical performance to quadripolar passive fixation leads, with a significantly lower risk of phrenic nerve stimulation at long-term follow-up.
Background: Bipolar active fixation (BipolarAFL) and quadripolar passive fixation left-ventricular leads (QuadPFL) have been designed to reduce the risk of phrenic nerve stimulation (PNS), enable targeted left-ventricular pacing, and overcome problems of difficult coronary venous anatomy and lead dislodgment. This study sought to report the long-term safety and performance of a BipolarAFL, Medtronic Attain Stability 20066, compared to QuadPFL. Methods: We performed a single-operator retrospective analysis of 81 patients receiving cardiac resynchronization therapy (CRT) (36 BipolarAFL, 45 QuadPFL). Immediate implant data and electrical and clinical data during follow-up (FU) were analyzed. Results: BipolarAFL has been chosen in patients with significantly larger estimated vein diameter (at the lead tip: 7.2 ± 4.1 Fr vs. 4.1 ± 2.3 Fr, p < 0.001) without significant time difference until the final lead position was achieved (BipolarAFL: 20.9 ± 10.5 min, vs. QuadPFL: 18.9 ± 8.9 min, p = 0.35). At 12 month FU no difference in response rate to CRT was recorded between BipolarAFL and QuadPFL according to left ventricular end-systolic volume (61.1 vs. 60.0%, p = 0.82) and New York Heart Association (66.7 vs. 62.2%, p = 0.32). At median FU of 48 months (IQR: 44–54), no lead dislodgment occurred in both groups but a significantly higher proportion of PNS was recorded in QuadPFL (13 vs. 0%, p < 0.05). Electrical parameters were stable during FU in both groups without significant differences. Conclusion: BipolarAFL can be implanted with ease in challenging coronary venous anatomy, shows excellent electrical performance and no difference in clinical outcome compared to QuadPFL.
No takes yet. Share an insight, caveat, or question.
Schiedat et al. (2021) conducted a cohort in Heart failure with reduced ejection fraction and bundle branch block (n=81). Bipolar active fixation left-ventricular lead (Medtronic Attain Stability 20066) vs. Quadripolar passive fixation left-ventricular lead was evaluated on Response rate to CRT (LVESV reduction ≥ 15%) at 12 months (p=0.82). Bipolar active fixation leads demonstrated similar 12-month CRT response rates compared to quadripolar passive fixation leads (61.1% vs. 60.0%) but significantly reduced phrenic nerve stimulation (0% vs. 13%) over 48 months.
Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context: