Report on efficacy and safety of leadless pacemaker published in Spain

A leadless pacemaker is an autonomous intracardiac device designed to perform the same function as conventional pacemakers. They are implanted using a catheter that guides the experts into the right ventricle through the femoral vein. The main contribution of this device is the absence of the leads and the external generator, so the surgical pocket is eliminated reducing the risks associated with it.

AETSA has assessed efficacy and safety of the leadless pacemaker by carrying out a systematic review. They have searched databases such as  MEDLINE, EMBASE, Web of Science, PREMEDLINE, Cochrane Library databases and ClinicalTrials.gov. In addition, other websites were also explored, for example, CRD, INAHTA, NICE, National and International Health Technology Assessment Units included in INAHTA and POP Database (EUnetHTA). Documents published up to December 2017 were considered.

Thirty (30) documents were identified and used for this report: one (1) synthesis report, eighteen (18) case series ((5 on Nanostim and 13 on Micra pacemakers) and eleven (11) case reports (2 corresponding to the Nanostim and 9 to the Micra device). No direct comparisons with conventional systems were identified.

Based on the documents mentioned above, AETSA has discovered that a leadless pacemaker is successfully implanted in most patients (95.8 – 100%) and has low stimulation thresholds during at least 12 months of follow-up (< 1 V at 0.24 ms). Regarding the safety of this device, cardiovascular mortality ranged 0 – 4.4 %, with a low percentage of migration after its correct location (maximally 0.13 %). Thirty-six (36) cases of systemic infection were documented, none of which are related to the implantation procedure or the device itself. Other adverse events identified had rarely occurred, the most frequent being the cardiac perforation, the presence of arrhythmias, vascular complications at the puncture site, endocarditis, atrial fibrillation or ventricular tachycardia, peripheral vascular complications and thromboembolism.

Conclusion

The obtained evidence does not demonstrate the non-inferiority or the superiority of this device compared to the conventional ones. However, leadless pacemakers could be the potential treatment of patients with an indication for VVI stimulation and contraindications to traditional pacemakers. It is necessary to define precisely the clinical scenarios in which their use would be justified and whose long-term follow-up would provide the required data on effectiveness and safety.

See the full report in Spanish (with summary in English) here.

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