Safety and Efficacy of Cardiac Implantable Electronic Devices (Cieds) in Tertiery Care Centre in Emerging Nation (India)

Abstract

Aim: To evaluate safety and efficacy of the Cardiac Implantable Electronic Devices (CIEDs) in tertiary care centre in emerging nation (India). Methodology: This is a retrospective as well as prospective, open label, single centre, study that evaluates the safety and efficacy of CIEDs like Implantable Cardioverter Defibrillator (ICD), Cardiac Resynchronization therapy-Defibrillator (CRT-D), Cardiac Resynchronization Therapy (CRT-P) and Permanent Pacemaker (PP) implantations. The study was performed at (CIMS) hospital, Ahmedabad from September 2013 to March 2014. The project has been approved by the IEC, CIMS hospital, Ahmedabad. Informed consent was taken from the patients for their enrollment in the study. The patients with the CIED implantation were identified based upon their inclusion and exclusion criteria. Base line data inlcuding demorgraphic details, risk factors, medications, physical examination, surgical procedure and device implantation related data of the enrolled patients were extracted from the medical record department (MRD). The details were filled in the case report form designed for this study. Quality of life questionnaire was filled-up using SF- 36 health survey form post implantation of CIEDs. Results: Study includes total of 445 patients. Amongst all the patients 66 patients were of ICD, 34 patients of Cardiac Resynchronization therapy-Defibrillator (CRT-D), 44 patients of Cardiac Resynchronization Therapy (CRT-P) and 301 patients of Permanent Pacemaker Implantation (PPI) implantations. Patients were assessed for their safety and device efficacy. The risk factors in the patients requiring CIED implantation are smoking, tobacco chewing, alcohol consumption and co-morbidities like diabetes and hypertension. The number of patients undergoing device replacement due to lead malfunction are 8(12.12%), 3(8.82%), 1(2.27%) and 7(2.32%) in ICD, CRT-D, CRT-P and PPI respectively. Rate of device site infection were 1(2.94%) in CRT-D and 2(0.66%) in PPI. No case of infection was seen in ICD and CRT-P. There was one case of device site hematoma among CRT-P patient. The mortality rates were 4(6.06%), 1(2.94%), 7(15.90%) and 13(4.31%) in ICD, CRT-D, CRT-P and PPI respectively. Overall QoL were satisfactory in the patients with any of the device. More than 70% of the patients had ratings of QoL, either average or above average.Conclusion: Although there was a limited access to the patient’s data and other device related information, some of the results were comparable to that of the studies performed in developed. This study may be helpful for understanding the safety and effectiveness of the CIEDs. However the results obtained are in a small population, hence a larger, multi-centric study should be conducted to address this issue and to get detailed data on all the devices.