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The primary safety endpoint at 6 months was successfully met for the Nanostim LP. The occurrence of cardiac perforation and device dislodgement declined after changes following the study pause.

We believe that the permanent femoral implant utilizing the technical modifications described in this article, offers an alternative to epicardial lead placement when the usual upper venous tree access is not available.

PurposeUse of novel medical technologies, such as leadless pacemaker (LP) therapy, may be subjected to a learning curve effect. The objective of the current study was to assess the impact of operators’ experience on the occurrence of serious adverse device effects (SADE) and procedural efficiency.MethodsPatients implanted with a Nanostim LP (Abbott, USA) within two prospective studies (i.e., LEADLESS ll IDE and Leadless Observational Study) were assessed. Patients were categorized into quartiles based on operator experience. Learning curve analysis included the comparison of SADE rates at 30 days post-implant per quartile and between patients in quartile 4 (> 10 implants) and patients in quartiles 1 through 3 (1–10 implants). Procedural efficiency was assessed based on procedure duration and repositioning attempts.ResultsNanostim LP implant was performed in 1439 patients by 171 implanters at 60 centers in 10 countries. A total of 91 (6.4%) patients experienced a SADE in the first 30 days. SADE rates dropped from 7.4 to 4.5% (p = 0.038) after more than 10 implants per operator. Total procedure duration decreased from 30.9 ± 19.1 min in quartile 1 to 21.6 ± 13.2 min (p < 0.001) in quartile 4. The need for multiple repositionings during the LP procedure reduced in quartile 4 (14.8%), compared to quartiles 1 (26.8%; p < 0.001), 2 (26.6%; p < 0.001), and 3 (20.4%; p = 0.03).ConclusionsLearning curves exist for Nanostim LP implantation. Procedure efficiency improved with increased operator experience, according to a decrease in the incidence of SADE, procedure duration, and repositioning attempts.Electronic supplementary materialThe online version of this article (10.1007/s10840-018-0438-8) contains supplementary material, which is available to authorized users.

Permanent pacemaker implantation through femoral access is not difficult for an experienced implant surgeon. Outcomes were comparable to systems implanted by superior venous approach, and no severe complications were observed at 10-year follow-up.

In the 75% of patients with moderate or high mobility, there were no DVT cases. The 6.4% DVT incidence was limited to patients with low mobility and was significantly lower than the norm for this procedure. A larger, randomized study is needed to confirm the benefits of the mobility allowed by an active-fixation lead.

A quadripolar lead offers multiple additional pacing options to increase CO acutely compared to conventional bipolar leads.

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