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.
Methods
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.
Results
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.
Conclusions
The observed adverse event rate of 5.5% is close to both international and Indian data. Our findings also indicate that the majority of adverse events occurred in patients aged over 50 years. Hence, age may be a concerning factor in the implantation of such devices; however, this was not statistically significant in our results. Gender-based examination showed no disparities between males and females across the various evaluated variables. Our findings emphasize the importance of early postoperative monitoring and prevention of complications such as device infection and lead dislodgement; however, the smaller sample size and short follow-up duration warrant further investigation to obtain more specific outcomes. Our study also supports the vision of the MvPI and may be helpful in conducting similar single-arm, single-center observational studies on the safety and reporting of CPs in larger cohorts with extended follow-up.
Study concept and design (JA, AH, SZR), acquisition of data, analysis and interpretation of data, drafting of the manuscript (JA), critical revision of the manuscript for important intellectual content (SZR, AH, MAH, MS), final review and editing (MAH, MS), and study supervision (SZR, AH). All authors have made significant contributions to this study and have approved the final manuscript.
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The study was recently published in the Exploratory Research and Hypothesis in Medicine .
Exploratory Research and Hypothesis in Medicine (ERHM) publishes original exploratory research articles and state-of-the-art reviews that focus on novel findings and the most recent scientific advances that support new hypotheses in medicine. The journal accepts a wide range of topics, including innovative diagnostic and therapeutic modalities as well as insightful theories related to the practice of medicine. The exploratory research published in ERHM does not necessarily need to be comprehensive and conclusive, but the study design must be solid, the methodologies must be reliable, the results must be true, and the hypothesis must be rational and justifiable with evidence.
