Key result
Early Micra leadless pacemaker experience carries a ~10% major complication rate, emphasizing operator training.
Why the study?
Serious complications including death can occur with leadless pacemaker implantation even among experienced operators, highlighting the need for adequate training and understanding of the learning curve.
Requires rigorous operator training for early Micra use; leaves open whether rates decline with broader experience.
We thank Dr Clementy for his interest in our article, and especially for sharing his own experience with the Micra transcatheter pacing system. It is interesting to note that the rate of major complications in his first 35 cases was 11.4%,1 a figure very similar to the 9.8% we experienced in our series (with all major perioperative complication occurring during the operators’ first 10 cases).2 This underlines how serious complications (including death) can occur with a new technique, even in case of previous extensive experience in device implantation. We fully agree that adequate training is essential, especially as it is very likely that this therapy is going to be adopted by smaller centres and less experienced operators. Dr Clementy also raises the important issue of caseload for maintaining competency. It would be of great interest to analyse existing data to evaluate the learning curve associated with this technique, as well as better understand risk factors associated with complications. This should ultimately lead to guidelines to provide a framework for this therapy.
No takes yet. Share an insight, caveat, or question.
Burri et al. (2018) conducted a letter in Leadless pacemaker implantation. Micra transcatheter pacing system was evaluated on Major complications. Early experience with the Micra transcatheter pacing system showed major complication rates around 9.8% to 11.4% in initial cases, highlighting the critical need for adequate operator training.
Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context: