VitaPace, pacemaker management software

VitaPace is Technesthai's software platform for the clinical management of patients with implantable cardiac devices: pacemakers, implantable cardioverter-defibrillators (ICDs) and cardiac resynchronization therapy devices (CRT). As pacemaker management software and implantable cardiac device management software, it supports the full patient pathway, from implantation to periodic follow-up, centralizing clinical demographics, device parameters, recorded arrhythmic events, battery status and reporting documentation. It is designed for cardiac pacing centers and cardiology departments looking for software for cardiac pacing centers, either as an alternative or as a complement to general electronic health records.

VitaPace manages the main categories of implantable cardiac devices: pacemakers (single- and dual-chamber), implantable cardioverter-defibrillators (ICDs) and cardiac resynchronization therapy devices (CRT-P and CRT-D). For each device, the system supports ICD CRT patient management by tracking technical data for the device and leads, initial programming parameters and later revisions, recorded arrhythmic events and procedure documentation. The integrated pacemaker implant registry software helps maintain a specialist and up-to-date dataset. The nomenclature follows NASPE/NBG codes (NASPE/BPEG Generic Code), the international coding system for the functional classification of pacemakers and ICDs.

The data managed by VitaPace falls within special categories of personal data under Article 9 of Regulation (EU) 2016/679 (GDPR), which requires enhanced security measures for healthcare data processing. VitaPace addresses this requirement with database encryption at rest, role-based access control (cardiologist, specialized nurse, technician, administrator) and immutable tracking of changes. All operations on clinical data are documented with timestamp and user, generating an audit trail that can be used in case of a data access request by the data subject, a controller review or an inspection by the Italian Data Protection Authority.

Regulation (EU) 2017/745 on medical devices (MDR), fully applicable from 26 May 2021, imposes strict requirements on device traceability through the UDI (Unique Device Identification) system and on post-implant clinical documentation. VitaPace supports healthcare centers in meeting these obligations by recording, for each patient, the UDI identifiers of the device and leads, implantation documentation and the follow-up data required for post-market surveillance. The system maintains complete traceability that can be reconstructed retrospectively, whether in the event of a manufacturer recall or a vigilance investigation by the competent authority.

Follow-up for patients with implantable cardiac devices requires periodic checks according to the guidelines of the European Society of Cardiology (ESC) and the European Heart Rhythm Association (EHRA): typically every 3-12 months depending on device type and clinical condition. VitaPace includes a dedicated follow-up module that automatically generates the control schedule, records the parameters detected by the device (battery status and estimated remaining longevity, pacing thresholds, lead impedance), arrhythmic events recorded by the device and any programming adjustments. For each visit, the system produces a report based on templates customizable by the center, reducing reporting time.

NASPE codes, more precisely NBG codes (NASPE/BPEG Generic Code), are the international classification system that describes pacemaker and ICD operating modes in concise form. Each device is identified by a letter string encoding the paced chamber, sensed chamber, response to sensing and other programmable features. Correct coding is essential for clinical documentation, communication between centers and registry statistics. VitaPace includes continuously updated NASPE codes and nomenclatures within the license, reducing the need for manual reference tables and the risk of coding errors in reports.

Yes. Managing patients with implantable cardiac devices typically involves electrophysiology cardiologists, nurses specialized in device follow-up and cath lab technicians. VitaPace supports multi-user access with differentiated authorization profiles: the system makes it possible to define who can enter clinical data, who can modify recorded programming, who can access data in read-only mode and who can export aggregate reports. All changes are tracked in an audit trail with timestamp and user, generating complete documentation of clinical activity. This model supports the separation of duties required by good clinical practice and GDPR accountability requirements.

A general electronic health record is designed to manage the entire patient pathway, but it rarely offers the specialist level of detail required for implantable cardiac device management: device programming parameters, lead data, arrhythmic events recorded by the pacemaker, NASPE coding and periodic follow-up according to specialist guidelines. VitaPace is designed specifically for cardiac pacing centers and natively covers these needs, reducing the need for parallel documentation on Excel sheets or paper forms. It can be used as a standalone system for centers that do not have an integrated electronic health record, or alongside a general record for the specialist component.