Key result
Operator experience of more than 10 Nanostim leadless pacemaker implants was associated with a significant reduction in 30-day serious adverse device effects to 4.5%, compared to 7.4% for operators with 1 to 10 implants.
Why the study?
Does increased operator experience improve safety and procedural efficiency in patients undergoing Nanostim leadless pacemaker implantation?
Observational (n=1,439)
Yes
Does increased operator experience improve safety and procedural efficiency in patients undergoing Nanostim leadless pacemaker implantation?
The incidence of serious adverse device effects and procedure duration significantly decrease after an operator performs more than 10 Nanostim leadless pacemaker implantations, demonstrating a clear learning curve.
Answers are grounded in this paper and cite their sources.
May inform Nanostim training thresholds; leaves open need for prospective validation of experience effects.
PURPOSE: Use 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. METHODS: Patients 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. RESULTS: Nanostim 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). CONCLUSIONS: Learning 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.
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Tjong et al. (2018) conducted an observational in Bradycardia requiring single-chamber pacing (n=1,439). Operator experience of >10 implants vs. Operator experience of 1-10 implants was evaluated on Serious adverse device effects (SADE) at 30 days post-implant (p=0.038). Operator experience of more than 10 Nanostim leadless pacemaker implants was associated with a significant reduction in 30-day serious adverse device effects to 4.5%, compared to 7.4% for operators with 1 to 10 implants.
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