What is the clinical evidence from this study?

Study design: Cohort. Population: Bradyarrhythmias requiring pacemaker implantation (n=36104). Intervention: Active fixation pacemaker leads vs. Passive fixation pacemaker leads. Primary outcome: Pacemaker-related infection (HR 0.26, 95% CI 0.08-0.83, p=0.023).

What does this research mean for the field?

Active fixation pacemaker leads significantly reduce the risk of pacemaker-related infection compared to passive fixation leads, with no difference in the risk of heart perforation. Novelty: ClaimNovelty.NOVEL_FINDING. Consensus alignment: ConsensusAlignment.ESTABLISHES_NEW_DIRECTION.

June 15, 2015Open Access

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

Resultado clave

Active fixation pacemaker leads significantly reduced the risk of pacemaker-related infection compared to passive fixation leads (HR 0.26).

Diseño del estudio

Tipo

Cohort (n=36,104)

Multicéntrico

Sí

PICO estructurado

Do active fixation pacemaker leads reduce the risk of pacemaker-related infection and heart perforation compared to passive fixation leads in patients receiving a new pacemaker implant?

Población

36,104 patients who received a new pacemaker implant from January 1997 to December 2011, mean age 73.4±12.5 years, from the Taiwan National Health Insurance Database.

Intervención

Active fixation pacemaker leads

Comparador

Passive fixation leads or both fixation leads

Resultado

Early and late heart perforation, and early and late pacemaker-related infection over a three-year periodsafety

Active fixation pacemaker leads are associated with a significantly lower risk of pacemaker-related infection compared to passive fixation leads, without an increased risk of heart perforation.

Resultado numérico

Estimación del efecto: HR 0.26 (95% CI 0.08-0.83)

Tasa de eventos absoluta: 0.19% vs 0.7%

valor p: p=0.023

Limitaciones

Procedure details could not be obtained since data were from an insurance system based on ICD-9 codes.
Severity of the complications could not be obtained from the database, potentially leading to underestimation of some complications.

Resumen

BACKGROUND: Several 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 RESULTS: Patients 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). CONCLUSIONS: There was no difference in heart perforation between active and passive fixation leads. Active fixation leads were associated with reduced risk of pacemaker-related infection.

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