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.

Compression stockings for treating vasovagal syncope (COMFORTS-II) trial: Rationale and design of a triple-blind, multi-center, randomized controlled trial.

BACKGROUND: Reduced venous return is an important trigger of vasovagal syncope (VVS). Elastic compression stockings (ECS) can modify venous return and be of therapeutic interest; however, evidence for ECS efficacy in VVS is scarce. This randomized controlled trial was designed to address the issue. METHODS: COMFORTS-II is a multicenter, triple-blind, parallel design, randomized controlled trial aimed to assess the efficacy of ECS in preventing VVS recurrences. Using central online randomization, 268 participants will be allocated to 2 arms (1:1 ratio), wearing intervention ECS (25-30 mm Hg pressure) or sham ECS (≤10 mm Hg pressure). All participants will receive standard VVS treatment in the form of education, and lifestyle modification recommendations (drinking 2-3 l/d of fluids and consuming 10 g/d-roughly half a tablespoon-of table salt). Adherence to ECS treatment will be evaluated through diary sheets, and compared between study arms. Follow-up continues for 1 year, and is conducted via a 24/7 phone line available to patients and trimonthly visits. The co-primary outcomes are proportion of participants with any syncopal recurrence and time to first syncopal episode. Secondary outcomes include frequency of VVS spells, time intervals between recurrences, and incidence of any patient-reported adverse effects. CONCLUSION: To the best of our knowledge, COMFORTS-II is the first clinical trial to assess ECS efficacy among patients with VVS, addressing an important gap in evidence for VVS treatments.

Comparison of Outcomes with Midodrine and Fludrocortisone for Objective Recurrence in Treating Syncope (COMFORTS trial): Rationale and design for a multi-center randomized controlled trial.

BACKGROUND: The cornerstone of the treatment of vasovagal syncope (VVS) is lifestyle modifications; however, some patients incur life-disturbing attacks despite compliance with these treatments which underscores the importance of pharmacological interventions. METHODS: In this open-label multi-center randomized controlled trial, we are going to randomize 1375 patients with VVS who had ≥2 syncopal episodes in the last year into three parallel arms with a 2:2:1 ratio to receive midodrine, fludrocortisone, or no medication. All patients will be recommended to drink 2 to 3 liters of fluids per day, consume 10 grams of NaCl per day, and practice counter-pressure maneuvers. In medication arms, patients will start on 5 mg of midodrine TDS or 0.05 mg of fludrocortisone BD. After one week the dosage will be up-titrated to midodrine 30 mg/day and fludrocortisone 0.2 mg/day. Patient tolerance will be the principal guide to dosage adjustments. We will follow-up the patients on 3, 6, 9, and 12 months after randomization. The primary outcome is the time to first syncopal episode. Secondary outcomes include the recurrence rate of VVS, time interval between first and second episodes, changes in quality of life (QoL), and major and minor adverse drug reactions. QoL will be examined by the 36-Item Short Form Survey questionnaire at enrollment and 12 months after randomization. CONCLUSION: The COMFORTS trial is the first study that aims to make a head-to-head comparison between midodrine and fludrocortisone, against a background of lifestyle modifications for preventing recurrences of VVS and improving QoL in patients with VVS.

Update on the efficacy of statins in primary and secondary prevention of atrial fibrillation.

Atrial fibrillation is the most common arrhythmia in adults and its prevalence is growing rapidly. It has been shown that AF is associated with increased risk of heart failure, ischemic and hemorrhagic stroke, and mortality. Hence, there is growing interest among researchers in seeking preventive and therapeutic interventions regarding AF. In recent decades, it has been suggested that statins may decrease the incidence of AF and may also decrease its recurrence after cardioversion and catheter ablation. These effects are thought to be mediated by different mechanisms such as modulating inflammation, altering the properties of transmembrane ion channels, interfering with activation of matrix metalloproteinases, and acting on endothelial function. In this article, we review and update current knowledge about the role of statins in primary and secondary prevention of AF in general and specific populations.

Conservative Management of Left Atrial Intramural Hematoma after Catheter Ablation.

Left atrial intramural hematoma is a very rare complication of radiofrequency ablation procedures. A patient with tachyarrhythmia underwent radiofrequency catheter ablation. Echocardiography performed the following morning showed a large mass in the left atrium, suggestive of intramural hematoma formation. The patient was in a stable condition; therefore, it was decided that follow-up should be conservative and her anticoagulation therapy was continued. The size of the hematoma decreased significantly over the following 50 days. This case highlights a rare complication of a complex catheter ablation procedure in the left atrium that was managed via a noninvasive approach, with which all interventionists should be familiar.

Development of mitral and tricuspid regurgitation in right ventricular apex versus right ventricular outflow tract pacing.

PURPOSE: This study aimed at comparing the development of tricuspid and mitral regurgitation between the right ventricular outflow tract (RVOT) and right ventricular apex (RVA) pacing. METHODS: We prospectively enrolled 164 patients for permanent pacemaker implantation due to sick sinus syndrome or atrioventricular block and randomly divided them into two equal groups to receive either RVOT or RVA pacing. Patients with heart failure or valvular disease were excluded. The post-procedural echocardiographic evaluations were performed 1 year after the pre-procedural echocardiography, and the results were compared with respect to the development of mitral and tricuspid regurgitation and probable changes in the ejection fraction (EF). RESULTS: Age, gender, pacing mode, and baseline cardiac rhythm did not significantly differ between the RVOT and RVA pacing groups. The incidence of mitral regurgitation was significantly higher in the RVA group (p = 0.03), but the incidence of tricuspid regurgitation was similar in both groups. There was a trend toward less tricuspid regurgitation in the RVOT group; however, it was not statistically significant. The mean EF was not significantly different between the study groups. CONCLUSION: It seems that the incidence of mitral regurgitation in RVA pacing is significantly higher than that in RVOT pacing. The formation of tricuspid regurgitation needs to be discussed in the future. CLINICAL TRIAL REGISTRATION NUMBER: IRCT201103146061N1.

Atrial dissociation in a middle aged patient: a case report.

Atrial dissociation is characterized by different types of P waves captured in an electrocardiogram, usually seen in critically ill or post-cardiac transplantation patients. Our case demonstrates a 55-year-old man, presenting with chest pain (unstable angina) in the emergency department with transient double-P waves; representing the phenomenon. Our case did not have any of the suggested causes or any known cardiac problems; therefore, with ruling out other differential diagnosis, researches must be done to find another explanation, if repeated.

Outcome of mitral valve repair in a patient with systemic lupus erythematosus.

We present a 17-year-old woman with a 5-year history of systemic lupus erythematosus (SLE). The patient referred to us with the rheumatic involvement of the mitral valve and was treated with mitral valve repair by ring annuloplasty and anterior leaflet augmentation with autologous pericardium. Follow-up, however, disclosed precocious calcification of the valve, necessitating mitral valve replacement.

Traumatic pulmonary arteriovenous fistula may be misdiagnosed with residual shunt after patent foramen ovale closure.

We report the case of a 48-year-old woman with a history of transient ischaemic attacks (TIA). The patient was diagnosed with a large patent foramen ovale (PFO), for which she underwent percutaneous PFO closure. Two years postprocedurally, the patient suffered frequent TIA and assessment showed the displacement of the device. The device was surgically removed, and the septum was repaired with a pericardial patch. Afterward, however, the patient experienced repeat TIA. It was discovered that the patient had a pulmonary arteriovenous fistula (PAVF), and a diagnosis of a trauma was made. The PAVF was later coil embolised. This case illustrates the importance of evaluating PFO closure patients for the associated causes of right-to-left shunting.