Outcome of 13,210 pacemaker implants using passive-fixation leads in conventional pacing: two decades of single-center experience (2005-2025)

Background Active-fixation pacing leads have established themselves as being the default option in most implant centers for better stability, site selectivity and extraction reasons, however passive fixation leads have long been used and provide simpler and shorter procedural time, are less expensive and have a lower rate of mechanical failure and cardiac perforations. Aim To assess the general outcome and complications of pacemaker (PM) implant procedures in a population paced exclusively with passive-fixation leads. Materials and methods This is a single-center retrospective study spanning 20 years from 2005 to 2025, with implant procedures perfomed by 9 experienced operators. Data was manually collected from procedure registries, hospital electronic health records and subsequent followups. We documented data regarding lead performance, device upgrade and box change rates, heart failure (HF) incidence, periprocedural and long term complication rates, implant fluoroscopy time and dose area product (DAP). Results 13,210 pacemaker implant procedures were documented, 6182 (46.8%) devices were dual-chamber, while 7028 (53.2%) were single-chamber. A total of 19,392 passive-fixation leads from various manufacturers were implanted, 6201 atrial and 13,191 ventricular. 10,832 (82%) of ventricular leads were positioned at the apex, septal pacing was achieved in 2378 (18%). Failure rate (lead continuity damage) was <0.5%, while major complications (defined as exit block – 0.4%, lead perforation – 0.04%, pocket infection – 1.09% or venous thrombosis – 0.2%) were observed in 337 cases. Dislodgment rate was 1.15% for ventricular leads and 1.95% for atrial ones, requiring either repositioning or replacement with an active-fixation lead. 1709 box-changes were performed. HF incidence reported at follow-up visits and box-changes was 21.2% with a mean follow-up period of 9.1 years (±7.7). Upgrade rates from VVI&AAI to DDD (due to AV block/Afib occurrence or pacemaker syndrome) was 4.3% and from RV pacing to CRT (due to HF) was 1.2%, a lower number due to lack of triple-chamber devices in early years. 18 leads required extraction (0.09%), with no extraction-related mortality having occurred (lower number due to lack of extraction capability in our center). Median implant fluoroscopy time was 64.16 (±58.35) seconds for single-chamber devices and 97.92 (±92.52) for dual-chamber, while median absorbed doses were 75.08 (±50.75) μGy·m2 for single and 75.93 (±45.37) μGy·m2 for dual. Conclusion Passive-fixation leads still represent a safe, robust and quick mean of providing cardiac pacing with low dose exposure to ionizing radiation. Complication rates with experienced operators are very low and non-RV apical pacing is attainable.