The document briefly presents the level of use of the technology and issues recommendations on patients and centres selection. Two leadless pacemakers are available on the Italian market: Nanostim (St. Jude Medical) and Micra TPS (Medtronic). However, it needs to be mentioned that the use of Nanostim is currently limited within the clinical study “LEADLESS Observational Study” (NCT02051972).
During 2016, 12 Micra TPS have been used in Veneto while 20 have been used in the first semester 2017 (246 in Italy). The cost of the Micra TPS is 7,500 EUR.
- Criteria for the selection of patients
The target population of leadless pacemakers is represented by those patients, older than 18, requiring permanent single-chamber right ventricular pacing presenting at least one of the following:
- Unsuitable superior venous access;
- Congenital malformations or postsurgical conditions not allowing access to the right ventricle from the superior vena cava;
- Need of singlechamber pacemaker re-implantation due to infection and risk factors or comorbidities linked to re-infection.
- Criteria for the selection of centres
Leadless pacemakers should be implanted within centres with the following characteristics:
- Experience in atrial fibrillation ablation procedures with cryoablation system and/or electroanatomical mapping systems and/or left and right ventricular arrhythmias ablation with electroanatomical mapping systems with big size long catheters (60 procedures per year, at least);
- High volume of conventional pacemakers implantation (250 procedures per year, at least);
- Cardiac surgery available on site;
- Specific training provided by the manufacturer.
In conclusion, since evidence of comparative effectiveness and safety is limited, leadless pacemakers should be subjected to controlled introduction for two years to allow outcomes data collection and analysis.
See the report in Italian here.
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