Cardiac pacemaker implantation is a primary therapy for various arrhythmic disorders; however, safety concerns persist in India. This study aimed to evaluate two-year safety outcomes of cardiac pacemakers, implantable cardioverter-defibrillators, and cardiac resynchronization therapy devices in a tertiary care setting.
In this prospective cohort study, data collection was conducted over a one-year enrolment period (February 2023 to January 2024), encompassing patient demographics, pacemaker implantation details, indications, and comorbidities. Patients were prospectively followed for a total of two years from enrolment—during the data collection period and for an additional year, to record device-associated adverse events. Ethical approval was obtained (IECJNMC/1662), and data were analyzed using SPSS.
Among 183 patients, 95% received cardiac pacemakers, 3% cardiac resynchronization therapy devices, and 2% implantable cardioverter-defibrillators. The data comprised 58% males (mean age, 63 years). The adverse event rate was 5.5% (10/183), distributed as 3.8% device infection, 1.09% lead dislodgement, and 0.54% generator dysfunction, with no statistical difference between males and females (P > 0.05). Different age groups, various indications, and several comorbidities showed no significant disparities (P > 0.05) between males and females. The Cox model showed no significant effect of several predictors on the occurrence of adverse events (P > 0.05). The Kaplan–Meier survival curve revealed a higher incidence of adverse events in the first six months, followed by stabilization. Adverse events were appropriately documented and reported to the Indian Pharmacopoeia Commission.
The observed adverse event rate of 5.5% supports previous Indian and international data; however, the smaller sample size and short follow-up duration warrant further investigation for more specific outcomes.
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