Impact of Pacemaker Lead Characteristics on Pacemaker Related Infection and Heart Perforation: A Nationwide Population-Based Cohort Study

Abstract

BackgroundSeveral risk factors for pacemaker (PM) related complications have been reported. However, no study has investigated the impact of lead characteristics on pacemaker-related complications.Methods and ResultsPatients who received a new pacemaker implant from January 1997 to December 2011 were selected from the Taiwan National Health Insurance Database. This population was grouped according to the pacemaker lead characteristics in terms of fixation and insulation. The impact of the characteristics of leads on early heart perforation was analyzed by multivariable logistic regression analysis, while the impact of the lead characteristics on early and late infection and late heart perforation over a three-year period were analyzed using Cox regression. This study included 36,104 patients with a mean age of 73.4±12.5 years. In terms of both early and late heart perforations, there were no significant differences between groups across the different types of fixation and insulations. In the multivariable Cox regression analysis, the pacemaker-related infection rate was significantly lower in the active fixation only group compared to either the both fixation (OR, 0.23; 95% CI, 0.07–0.80; P = 0.020) or the passive fixation group (OR, 0.26; 95% CI, 0.08–0.83; P = 0.023).ConclusionsThere was no difference in heart perforation between active and passive fixation leads. Active fixation leads were associated with reduced risk of pacemaker-related infection.

Outcomes of transvenous lead extraction in patients with lead perforation: A single‐center experience

“…However, in the present study, of the 53 perforated leads, nearly 30% were passive‐fixation leads. Furthermore, a recent population‐based cohort study performed in Taiwan reported no difference in the risk of cardiac perforation between active‐ and passive‐fixation pacing leads . Given that the atrial myocardium is thinner than the ventricular myocardium, it is easy to speculate that atrium perforation is more frequent than ventricle perforation, which has indeed been confirmed by previous studies …”

Incidence of Cardiac Perforation With Conventional and With Leadless Pacemaker Systems: A Systematic Review and Meta‐Analysis

“…These factors can be categorized as lead design‐, physician expertise‐, and patient‐related factors . One of the most investigated design characteristics is the type of the fixation . The use of active fixation leads compared to passive fixation leads was associated with a higher perforation rate in our meta‐analysis (POR 4.25, 95% CI, 1.00–17.95).…”

“…Of all identified studies, only one was a randomized controlled clinical trial, whereas the remainder were post‐hoc analyses of randomized trials or observational retrospective or observational prospective studies . The vast majority were single‐center observations, with the exception of 8 multicenter studies, and 2 were based on national or industrial registries . Individual studies used different definitions of lead perforation including signs of periprocedural pericarditis, asymptomatic pericardial effusion, or pericardial tamponade (Tables and ).…”

“…Implantation of transvenous endocardial leads became a safe and relatively simple procedure, although careful electrode placement is still a critical part of the procedure. Lead perforation has been reported in various case reports, 1-4 prospective [5][6][7][8][9][10][11][12] or retrospective [13][14][15][16][17][18][19][20][21][22][23][24][25][26][27][28][29][30] trials and registry databases, 31,32 but a detailed comprehensive analysis of this complication is lacking.…”

Less typical form and less typical clinical picture of atrial wall subacute perforation with atrial lead

“…Perforations can be classified as acute (5-7 days after device implantation), subacute (7-30 days) and late or delayed (more than 30 days). According to published data, implantation of a pacemaker is associated with a risk of heart perforation of 0.1-1.2% or even lower (0.06% for non-early perforation) [1] . Perforation as a subacute complication is even rarer, but reported [2] .…”