Comparison of Single- vs. Dual-Lead CIEDs Regarding Perioperative Complications-Analysis of the Quality Assurance Data of the State of North Rhine-Westphalia, Germany

<b>Background/Objective:</b> Previous studies have indicated a higher incidence of complications associated with dual-lead devices compared to single-lead devices. This retrospective study aimed to investigate the effect of lead count and other factors on peri/postoperative complications for new pacemaker (PM) or implantable cardioverter-defibrillator (ICD) implantations in a representative German cohort. <b>Methods:</b> In accordance with quality assurance (QS) requirements, all hospitals in Germany collect patient-specific data on cardiac device implantation. We utilized the QS database from North Rhine-Westphalia to analyze data from 169,547 patients who underwent PM (<i>n</i> = 137,208) or ICD (<i>n</i> = 32,339) implantation between 2010 and 2014. The primary endpoint was the incidence of perioperative complications in the PM and ICD groups, analyzed separately for single- and dual-lead systems. Regression analysis was performed to identify specific risk factors and the effect of lead number on complications. <b>Results:</b> In the PM group, patients with dual-lead devices experienced significantly more complications than those with single-lead devices (3.27% vs. 2.85%, <i>p</i> < 0.001), largely driven by lead dislocations. In the ICD group, no significant difference in complication rates was observed between single-lead and dual-lead devices (1.39% vs. 1.46%, <i>p</i> = 0.635). The risk of complications was over twice as high for PM implantation compared to ICD implantation (3.17% vs. 1.42%). Patients with intrahospital complications faced a significantly higher risk of mortality than those without complications (PM: 4.5% vs. 1.6%; ICD: 3.9% vs. 0.5%). Independent risk factors for complications and mortality were identified in both groups, with a notable increase in the risk of intrahospital mortality associated with complications. <b>Conclusions:</b> Complications of dual-lead PM implantations are higher than single-lead procedures, mostly due to lead dislocations. Such a difference, though, was not observed in ICD implantations. Our findings may help optimize procedural strategies to improve patient safety, especially in PM implantations.