Clinical outcomes of subcutaneous implantable cardiac defibrillator implantation - Iran SICD registry.

BACKGROUND: The subcutaneous implantable-defibrillator (S-ICD) is a relatively new alternative to the transvenous ICD system to minimize intravascular lead-related complications. This paper presents outcome of SICD implantation in patients enrolled in Iran S-ICD registry. METHODS: Between October 2015 and June 2022, this prospective multicenter national registry included 223 patients with a standard indication for an ICD, who neither required bradycardia pacing nor needed cardiac resynchronization to evaluate the early post-implant complications and long-term follow-up results of the S-ICD system. RESULTS: The mean age of the patients was 45 ± 17 years. The majority (79.4%) were male. Ischemic cardiomyopathy (39.5%) was the most common underlying disorder among patients selected for S-ICD implant. Most study patients (68.6%) had ICD for primary prevention of sudden cardiac death. Seven patients (3.1%) were found to have suboptimal lead positions. Six patients (2.7%) developed a pocket hematoma; all were managed medically. During a mean follow-up of 2 years, the appropriate therapy was recorded in 13% of the patients and inappropriate ICD intervention mainly due to supraventricular tachycardia in 8.9%. Pocket infection was observed in four patients (1.8%) and five patients (2.2%) died mainly due to heart failure. CONCLUSION: S-ICDs were effective at detecting and treating both induced and spontaneous ventricular arrhythmias. Major clinical complications were rare.

Postoperative antibiotic prophylaxis in the prevention of cardiac implantable electronic device infection.

BACKGROUND: The aim of the present study was to determine whether postprocedural antibiotic reduces the risk of infection related to the cardiac implantable electronic device (CIED) implantations. METHODS: The present investigation is a randomized, prospective, single-blinded controlled trial. All consecutive patients who presented for new CIED implantation, generator replacement, or upgrade were randomized into the following three groups: (A) no antibiotic, (B) intravenous (IV) antibiotic for 1 day, (C) 1 day IV plus 7 days oral antibiotic. Follow-up was performed on 10-12 days; 1, 3, 6 months; and then every 6 months for 2 years. The primary endpoint was any evidence of infection at the generator pocket or systemic infection related to the procedure at short-term (6-month) and long-term (2-year) follow-ups. RESULTS: Of the 450 patients (72 patients with cardiac resynchronization device) included in the study, the primary endpoint of short-term infection was reached in one patient (0.2%) in group A and no patients in groups B and C. The endpoint of long-term infection was reached in nine patients (2%) with equal frequency between three randomized groups (three patients in each group). On multivariable analysis, the only independent predictor of infection was defibrillator implantation (odds ratio, 8.5; 95% confidence interval, 1.6-45). CONCLUSIONS: The results of this prospective study showed no benefit for the postoperative antibiotic for the prevention of CIED infection.

Persian Registry Of cardioVascular diseasE (PROVE): Design and methodology.

BACKGROUND: Our aim was to create and establish a database called "Persian Registry Of cardioVascular diseasE (PROVE)" in order to be used for future research and in addition, as a tool to develop national guidelines for diagnosis, treatment, and prevention of cardiovascular disease (CVD). In this paper, the design and methodology of the PROVE pilot study will be discussed, launched in Isfahan, Iran, in 2015-2016. METHODS: Through establishing PROVE, patients' data were collected from hospitals and outpatient clinics prospectively or retrospectively and followed up for a maximum of three years based on the type of CVDs. The inclusion criteria were as patients with acute coronary syndrome (ACS), ST elevation myocardial infarction (STEMI), stroke, atrial fibrillation (AF), heart failure (HF), congenital heart disease (CHD), percutaneous coronary intervention (PCI), and chronic ischemic cardiovascular disease (CICD). Specific protocols, questionnaires, and glossaries were developed for each registry. In order to ensure the validation of the protocols, questionnaires, data collection, management, and analysis, a well-established quality control (QC) protocol was developed and implemented. Data confidentiality was considered. RESULTS: In order to register patients with ACS, STEMI, stroke, HF, PCI, and CICD, the hospital recorded data were used, whereas, in case of AF and CHD registries, the data were collected from hospitals and outpatient clinics. During the pilot phase of the study in Isfahan, from March 2015 to September 2016, 9427 patients were registered as ACS including 809 as STEMI, 1195 patients with HF, 363 with AF, 761 with stroke, 1136 with CHD, 1200 with PCI, and 9 with CICD. Data collection and management were performed under the supervision of the QC group. CONCLUSION: PROVE was developed and implemented in Isfahan as a pilot study, in order to be implemented at national level in future. It provides a valuable source of valid data that could be used for future research, re-evaluation of current CVD management and more specifically, gap analysis and as a tool for assessment of the type of CVDs, prevention, treatment, and control by health care decision makers.