Abstract
Background
A novel active fixation coronary sinus (CS) lead, Attain Stability, has been released in a bipolar and quadripolar configuration, with the hypothesis it will improve targeted lead positioning and stability independent of vessel anatomy.
Purpose
To compare implant procedure parameters and electrical performance/stability of a novel active fixation lead with passive fixation CS leads.
Methods
This was a retrospective study involving 6 major UK cardiac centres. Patients who received active leads were compared with passive lead recipients in a 1:2 ratio. The primary outcome was total lead displacements (combined macro/micro-displacements, defined as displacements requiring repositioning procedures, or an increase in threshold≥0.5 volts or pulse width≥0.5msec, or a change in pacing polarity). Multivariate analysis was performed to establish predictors of the primary outcome, assessing fixation mechanism (active or passive), number of poles (quad or bipolar), contributing hospital and follow-up duration.
Results
736 patients were included (241 with active leads, 495 with passive leads). There were no group differences in the baseline characteristics with respect to age, gender, EF, NYHA class, and co-morbidities, P>0.05 for all. The primary endpoint rate was 31% (74/241) in the active and 43% (213/495) in the passive fixation group (P=0.002). 6 patients in the active group and 14 in the passive group required CS lead repositioning procedures. The results of the multivariate analysis are presented in the Table. The use of active leads was associated with a significant reduction in lead displacements, odds ratio 0.62 (95% CI 0.43–0.9), P=0.012. There were differences in favour of passive compared with active leads in procedure duration, 120 [96–149] minutes vs 128 [105–155] minutes (P=0.011), and fluoroscopy time, 17 [11–26] minutes vs 18.5 [13–27] minutes (P=0.028). The median duration of follow up was similar (active vs passive): 31 [17–47] weeks vs 34 [16–71] weeks, (P=0.052).
Odds Ratio (95% Confidence Interval) P-value Active fixation CS lead 0.62 (0.43–0.9) 0.012 Quadripolar (rather than Bipolar) lead 1.26 (0.75–2.11) 0.376 Follow-up Duration (weeks) 1.005 (1.001–1.008) 0.025 Also included in the model: contributing hospital, which was significant.
Conclusion
In this large, multi-centre study, active fixation Attain Stability CS leads demonstrated superior electrical performance/stability compared with passive fixation leads, with minimal increases in implant procedure and fluoroscopy times.
Acknowledgement/Funding
None
Ratchet mechanism selectively causing idiopathic macrodislodgement of an active-fixation coronary sinus lead: a case report
