Key result
Both screw-in and suture-on epicardial leads demonstrated excellent long-term performance and durability with very low complication rates, showing no significant differences in pacing thresholds at 24 months.
Why the study?
Does the technical concept of epicardial LV leads (screw-in vs. suture-on) affect long-term lead performance and clinical outcomes in patients requiring CRT?
Observational (n=130)
No
Does the technical concept of epicardial LV leads (screw-in vs. suture-on) affect long-term lead performance and clinical outcomes in patients requiring CRT?
Absolute Event Rate: 0.9% vs 1.1%
Both screw-in and suture-on epicardial LV leads demonstrate excellent long-term durability and performance with no significant differences between the two concepts at 24 months.
May support flexibility in epicardial lead selection for CRT; leaves open superiority in randomized trials.
BACKGROUND: Epicardial left ventricular (LV) leads represent an alternative for CRT therapy if transvenous lead implantation fails. Data on endurance, performance, the impact of the surgical approach (lateral minithoracotomy vs. median sternotomy simultaneously with other cardiac surgery), and the optimal technical concept (screw-in vs. suture-on) is limited. METHODS: Over a period of 48 months we evaluated 130 consecutive patients with comparable characteristics. A total of 54 screw-in (MyoDex™ 1084T, SJM) and 76 suture-on (Capture Epi 4968, Medtronic) bipolar epicardial steroid-eluting LV leads were implanted either via a left lateral or a median thoracotomy. Sensing, pacing threshold, impedance and NYHA class were recorded at defined time points. RESULTS: No surgery-related death or major complication was observed. At the time of implantation, the pacing threshold, sensing and NYHA class did not differ significantly between the two groups. The impedances of screw-in leads were significantly lower compared to those of suture-on leads. Suture-on leads showed a moderate initial drop in their pacing threshold but afterwards remained stable. Screw-in leads were characterized by a moderate but significant increase in the pacing threshold in the first year followed by a continuous decrease thereafter. Twenty-four months post-implantation no differences between both lead types could be detected. Sensing and NYHA class improved in both groups. The surgical approach had no significant impact on lead functionality. CONCLUSION: Our study showed that the implantation of epicardial leads was safe with very low complication rates. There was no superior technical epicardial lead concept (screw-in vs. suture-on leads) and all epicardial leads demonstrated an excellent long-term performance and durability. Therefore, it seems that epicardial leads represent a good alternative to transvenous leads and surgeons should be encouraged to implant epicardial leads during concomitant cardiac surgery when the indications for CRT are present.
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Bürger et al. (2011) conducted an observational in Advanced heart failure requiring cardiac resynchronization therapy (n=130). Screw-in epicardial leads vs. Suture-on epicardial leads was evaluated on Pacing threshold at 24 months (V/0.5 ms). Both screw-in and suture-on epicardial leads demonstrated excellent long-term performance and durability with very low complication rates, showing no significant differences in pacing thresholds at 24 months.
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