Electrical performance of a novel extravascular temporary pacing lead system

An investigational extravascular (EV) cardiac temporary pacing system has been developed that includes a parasternally-positioned temporary pacing lead within the anterior mediastinum. The pacing lead is inserted using a custom delivery tool through a parasternal skin incision. This novel system may provide clinical advantages over existing device alternatives that require intravascular, endocardial, or epicardial contact.

The purpose of this study was to evaluate electrical performance of an EV temporary pacing lead over 48 hours.

In this single-center study, patients who underwent a transvenous (TV) permanent pacemaker implant or replacement were simultaneously implanted with the investigational EV temporary pacing lead. Electrical performance was evaluated through analysis of capture thresholds, impedance, and R-wave amplitudes during multiple times on the day of the procedure and on the subsequent 2 days of follow-up.

Lead insertions with acute capture were successful in all 8 patients (40% female, 71 ± 8 years, BMI 27 ± 3 kg/m2). Mean acute measurements for pacing capture threshold at 1.5 ms, impedance and R-wave amplitude were 6.2 mA, 1396 Ω, 5.4 mV, respectively. Pacing capture was maintained in 100% of assessments conducted over 3 days (Figure 1). There were no serious complications during insertion, removal or chronic use of the lead.

Results support that the investigational EV temporary pacing lead is capable of safely providing temporary pacing with thresholds typically well below the maximum output of temporary pacemakers.