Initial clinical experience with the balloon-in-basket pulsed field ablation system: acute results of the VOLT CE mark feasibility study.

AIMS: Pulsed field ablation (PFA) for the treatment of atrial fibrillation (AF) potentially offers improved safety and procedural efficiencies compared with thermal ablation. Opportunities remain to improve effective circumferential lesion delivery, safety, and workflow of first-generation PFA systems. In this study, we aim to evaluate the initial clinical experience with a balloon-in-basket, 3D integrated PFA system with a purpose-built form factor for pulmonary vein (PV) isolation. METHODS AND RESULTS: The VOLT CE Mark Study is a pre-market, prospective, multi-centre, single-arm study to evaluate the safety and effectiveness of the Volt™ PFA system for the treatment of paroxysmal (PAF) or persistent AF (PersAF). Feasibility sub-study subjects underwent phrenic nerve evaluation, endoscopy, chest computed tomography, and cerebral magnetic resonance imaging. Study endpoints were the rate of primary serious adverse event within 7 days and acute procedural effectiveness. A total of 32 subjects (age 61.6 ± 9.6 years, 65.6% male, 84.4% PAF) were enrolled and treated in the feasibility sub-study and completed a 30-day follow-up. Acute effectiveness was achieved in 99.2% (127/128) of treated PVs (96.9% of subjects, 31/32) with 23.8 ± 4.2 PFA applications/subject. Procedure, fluoroscopy, LA dwell, and transpired ablation times were 124.6 ± 28.1, 19.8 ± 8.9, 53.0 ± 21.0, and 48.0 ± 19.9 min, respectively. Systematic assessments of initial safety revealed no phrenic nerve injury, pulmonary vein stenosis, or oesophageal lesions causally related to the PFA system and three subjects with silent cerebral lesions (9.4%). There were no primary serious adverse events. CONCLUSION: The initial clinical use of the Volt PFA System demonstrates acute safety and effectiveness in the treatment of symptomatic, drug refractory AF.

Single ring isolation for atrial fibrillation ablation: Impact of the learning curve.

INTRODUCTION: Although single ring isolation is an accepted strategy for undertaking pulmonary vein (PV) and posterior wall isolation (PWI) during atrial fibrillation (AF) ablation, the learning curve associated with this technique as well as procedural and clinical success rates have not been widely reported. METHODS AND RESULTS: Prospectively collected data from 250 consecutive patients undergoing de novo AF ablation using single ring isolation. PWI was achieved in 212 patients (84.8%) and PV isolation without PWI was achieved in 37 patients (14.4%). Thirty-one cases (12.4%) demonstrated inferior line sparing where PWI was achieved without a continuous posterior wall inferior line. A learning curve was observed, with higher rates of PWI (98% last 50 vs. 82% first 50 cases, p = .016), higher rates of inferior line sparing (20% last 50 vs. 8% first 50 cases, p = .071) and lower ablation times (43.8 min (interquartile range [IQR]: 34.6-57.0 min) last 50 versus. 96.5 min (IQR: 80.8-115.8 min) first 50 cases; p < .001). Three (1.3%) major procedure-related complications were observed. Twelve-month, single-procedure freedom from atrial arrhythmia without drugs was 70.5% (95% confidence interval [CI]: 61.5%-77.7%) and 60.0% (95% CI: 50.2%-68.4%) for paroxysmal and persistent/longstanding persistent AF. Twelve-month multi-procedure freedom from atrial arrhythmia was 92.2% (95%CI: 85.6%-95.9%) and 85.6% (95%CI: 77.2%-91.0%) for paroxysmal and persistent/longstanding persistent AF. CONCLUSION: Employing a single ring isolation approach, PWI can be achieved in most cases. There is a substantial learning curve with higher rates of PWI, reduced ablation times, and higher rates of inferior line sparing as procedural experience grows. Long-term freedom from arrhythmia is comparable to other AF ablation techniques.

Low-frequency stimulation of a fiber tract in bilateral temporal lobe epilepsy.

OBJECTIVE: Pharmacoresistant bilateral mesial temporal lobe epilepsy often implies poor resective surgical candidacy. Low-frequency stimulation of a fiber tract connected to bilateral hippocampi, the fornicodorsocommissural tract, has been shown to be safe and efficacious in reducing seizures in a previous short-term study. Here, we report a single-blinded, within-subject control, long-term deep-brain stimulation trial of low-frequency stimulation of the fornicodorsocommissural tract in bilateral mesial temporal lobe epilepsy. Outcomes of interest included safety with respect to verbal memory scores and reduction of seizure frequency. METHODS: Our enrollment goal was 16 adult subjects to be randomized to 2-Hz or 5-Hz low-frequency stimulation of the fornicodorsocommissural tract starting at 2 mA. The study design consisted of four two-month blocks of stimulation with a 50%-duty cycle, alternating with two-month blocks of no stimulation. RESULTS: We terminated the study after enrollment of five subjects due to slow accrual. Fornicodorsocommissural tract stimulation elicited bilateral hippocampal evoked responses in all subjects. Three subjects underwent implantation of pulse generators and long-term low-frequency stimulation with mean monthly seizures of 3.14 ±â€¯2.67 (median 3.0 [IQR 1-4.0]) during stimulation-off blocks, compared with 0.96 ±â€¯1.23 (median 1.0 [IQR 0-1.0]) during stimulation-on blocks (p = 0.0005) during the blinded phase. Generalized Estimating Equations showed that low-frequency stimulation reduced monthly seizure-frequency by 0.71 per mA (p < 0.001). Verbal memory scores were stable with no psychiatric complications or other adverse events. SIGNIFICANCE: The results demonstrate feasibility of stimulating both hippocampi using a single deep-brain stimulation electrode in the fornicodorsocommissural tract, efficacy of low-frequency stimulation in reducing seizures, and safety as regards verbal memory.

Trends in the use, complications, and costs of permanent pacemakers in Australia: A nationwide study from 2008 to 2017.

OBJECTIVE: To characterize contemporary pacemaker procedure trends. METHODS: Nationwide analysis of pacemaker procedures and costs between 2008 and 2017 in Australia. The main outcome measures were total, age- and gender-specific implant, replacement, and complication rates, and costs. RESULTS: Pacemaker implants increased from 12,153 to 17,862. Implantation rates rose from 55.3 to 72.6 per 100,000, a 2.8% annual increase (incidence rate ratio [IRR] 1.028; 95% CI, 1.02-1.04; p < .001). Pacemaker implants in the 80+ age group were 17.37-times higher than the < 50 group (95% CI 16.24-18.59; p < .001), and in males were 1.48-times higher than in females (95% CI 1.42-1.55; p < .001). However, there were similar increases according to age (p = .10) and gender (p = .68) over the study period. Left ventricular lead rates were stable (IRR 0.995; 95% CI 0.98-1.01; p = .53). Generator replacements decreased from 20.5 to 18.3 per 100,000 (IRR 0.975; 95% CI 0.97-0.98; p < .001). Although procedures for generator-related complications were stable (IRR 0.995; 95% CI 0.98-1.01; p = .54), those for lead-related complications decreased (IRR 0.985; 95% CI 0.98-0.99; p < .001). Rates for all pacemaker procedures were consistently greater in males (p < .001). Although annual costs of all pacemaker procedures increased from $178 million to $329 million, inflation-adjusted costs were more stable, rising from $294 million to $329 million. CONCLUSIONS: Increasing demand for pacemaker implants is driven by the ageing population and rising rates across all ages, while replacement and complication procedure rates appeared more stable. Males have consistently greater pacemaker procedure rates than females. Our findings have significant clinical and public health implications for healthcare resource planning.

Factors Contributing to Exercise Intolerance in Patients With Atrial Fibrillation.

BACKGROUND: Reduced exercise capacity and exercise intolerance are commonly reported by individuals with atrial fibrillation (AF). Our objectives were to evaluate the contributing factors to reduced exercise capacity and describe the association between subjective measures of exercise intolerance versus objective measures of exercise capacity. METHODS: Two hundred and three (203) patients with non-permanent AF and preserved ejection fraction undergoing cardiopulmonary exercise testing (CPET) were recruited. Clinical characteristics, AF-symptom evaluation, and transthoracic echocardiography measures were collected. Peak oxygen consumption (VO2peak) was calculated during CPET as an objective measure of exercise capacity. We assessed the impact of 16 pre-defined clinical features, comorbidities and cardiac functional parameters on VO2peak. RESULTS: Across this cohort (Age 66±11 years, 40.4% female and 32% in AF), the mean VO2peak was 20.3±6.3 mL/kg/min. 24.9% of patients had a VO2peak considered low (<16 mL/kg/min). In multivariable analysis, echocardiography-derived estimates of elevated left ventricular (LV) filling pressure (E/E') and reduced chronotropic index were significantly associated with lower VO2peak. The presence of AF at the time of testing was not significantly associated with VO2peak but was associated with elevated minute ventilation to carbon dioxide production indicating impaired ventilatory efficiency. There was a poor association between VO2peak and subjectively reported exercise intolerance and exertional dyspnoea. CONCLUSION: Reduced exercise capacity in AF patients is associated with elevated LV filling pressure and reduced chronotropic response rather than rhythm status. Subjectively reported exercise intolerance is not a sensitive assessment of reduced exercise capacity. These findings have important implications for understanding reduced exercise capacity amongst AF patients and the approach to management in this cohort. (ACTRN12619001343190).

Magnetic resonance imaging in non-conditional pacemakers and implantable cardioverter-defibrillators: a systematic review and meta-analysis.

AIMS: There is growing evidence that magnetic resonance imaging (MRI) scanning in patients with non-conditional cardiac implantable electronic devices (CIEDs) can be performed safely. Here, we aim to assess the safety of MRI in patients with non-conditional CIEDs. METHODS AND RESULTS: English scientific literature was searched using PubMed/Embase/CINAHL with keywords of 'magnetic resonance imaging', 'pacemaker', 'implantable defibrillator', and 'cardiac resynchronization therapy'. Studies assessing outcomes of adverse events or significant changes in CIED parameters after MRI scanning in patients with non-conditional CIEDs were included. References were excluded if the MRI conditionality of the CIEDs was undisclosed; number of patients enrolled was <10; or studies were case reports/series. About 35 cohort studies with a total of 5625 patients and 7196 MRI scans (0.5-3 T) in non-conditional CIEDs were included. The overall incidence of lead failure, electrical reset, arrhythmia, inappropriate pacing and symptoms related to pocket heating, or torque ranged between 0% and 1.43%. Increase in pacing lead threshold >0.5 V and impedance >50Ω was seen in 1.1% [95% confidence interval (CI) 0.7-1.8%] and 4.8% (95% CI 3.3-6.4%) respectively. The incidence of reduction in P- and R-wave sensing by >50% was 1.5% (95% CI 0.6-2.9%) and 0.4% (95% CI 0.06-1.1%), respectively. Battery voltage reduction of >0.04 V was reported in 2.2% (95% CI 0.2-6.1%). CONCLUSION: This meta-analysis affirms the safety of MR imaging in non-conditional CIEDs with no death or implantable cardioverter-defibrillator shocks and extremely low incidence of lead or device-related complications.

Comparison of Outcomes Using the First and Second Generation Cryoballoon to Treat Atrial Fibrillation.

BACKGROUND: Pulmonary vein isolation using cryoballoon ablation is an effective treatment for patients with atrial fibrillation. We sought to compare outcomes with the first and second generation cryoballoon, with the second generation balloon incorporating the Achieve Lasso catheter, in terms of freedom from symptomatic recurrence and major complications. METHODS: The first 200 patients who underwent cryoballoon ablation with the first generation balloon were compared with the first 200 patients using the second-generation balloon. All patients had symptomatic atrial fibrillation and had failed at least one antiarrhythmic drug. The primary efficacy endpoint was freedom from symptomatic recurrence of atrial fibrillation (AF) after a single pulmonary vein isolation (PVI) procedure using the cryoballoon. The primary safety endpoint was major procedural complications. RESULTS: At 12 months, freedom from symptomatic AF after a single procedure in the first generation cohort was 64.3% compared with 78.6% in the second-generation cohort (p = 0.002). At 24 months, freedom from symptomatic AF in the first generation cohort was 51.3% compared with 72.6% in the second-generation cohort (p < 0.001). Procedural time (150 min vs 101 min; p < 0.001) and fluoroscopy time (32.5 min vs 21.4 min; p < 0.001) was lower in the second-generation group. The rate of major complications was comparably low in both groups. CONCLUSIONS: The second-generation cryoballoon was associated with improved freedom from symptomatic AF with reduction in procedure and fluoroscopy time, with a similar low rate of major complications.

Quality of Warfarin Anticoagulation in Indigenous and Non-Indigenous Australians With Atrial Fibrillation.

BACKGROUND: Studies have shown that suboptimal anticoagulation quality, as measured by time in therapeutic range (TTR), affects a significant percentage of patients with atrial fibrillation (AF). However, TTR has not been previously characterised in Indigenous Australians who experience a greater burden of AF and stroke. METHOD: Indigenous and non-Indigenous Australians with AF on warfarin anticoagulation therapy were identified from a large tertiary referral centre between 1999 and 2012. Time in therapeutic range was calculated as a proportion of daily international normalised ratio (INR) values between 2 and 3 for non-valvular AF and 2.5 to 3.5 for valvular AF. INR values between tests were imputed using the Rosendaal technique. Linear regression models were employed to characterise predictors of TTR. RESULTS: Five hundred and twelve (512) patients with AF on warfarin were included (88 Indigenous and 424 non-Indigenous). Despite younger age (51±13 vs 71±12 years, p<0.001), Indigenous Australians had greater valvular heart disease, diabetes, and alcohol excess compared to non-Indigenous Australians (p<0.05 for all). Time in therapeutic range was significantly lower in Indigenous compared to non-Indigenous Australians (40±29 vs 50±31%, p=0.006). Univariate predictors of poorer TTR included Indigenous ethnicity, younger age, diuretic use, and comorbidities, such as valvular heart disease, heart failure and chronic obstructive pulmonary disease (p<0.05 for all). Valvular heart disease remained a significant predictor of poorer TTR in multivariate analyses (p=0.004). CONCLUSION: Indigenous Australians experience particularly poor warfarin anticoagulation quality. Our data also suggest that many non-Indigenous Australians spend suboptimal time in therapeutic range. These findings reinforce the importance of monitoring warfarin anticoagulation quality to minimise stroke risk.

Catheter Ablation of Post-Infarct VT: Mechanisms, Strategies and Outcomes.

Ventricular arrhythmias are one of the leading causes of death in patients with a prior myocardial infarction. Implantable cardioverter-defibrillators (ICDs) are very effective in the prevention of sudden cardiac death but the risk of recurrence remains an issue since defibrillation does not alter the underlying substrate. Recurrent ICD shocks are distressing and are associated with an increase in mortality. Catheter ablation is an effective treatment for recurrent ventricular tachycardia in these patients, particularly when antiarrhythmic therapy produces side effects or is ineffective. This paper reviews the underlying mechanisms of VT in patients with a prior myocardial infarction, and the indications, strategies and outcomes of catheter ablation.

Epidemiology and clinical manifestations of juvenile myoclonic epilepsy (JME) in Iran.

Because most descriptive studies did not specifically analyze the syndromes of idiopathic generalized epilepsy (IGE), including juvenile myoclonic epilepsy (JME), epidemiologic data concerning these syndromes are scarce or often unreliable. In this retrospective chart review study, all patients with a clinical diagnosis of JME were recruited at the outpatient epilepsy clinic at Shiraz University of Medical Sciences, from 2008 to 2013. Demographic variables and relevant clinical and EEG variables were summarized descriptively. 2,750 patients with epilepsy were registered at our epilepsy clinic; 239 patients (8.7 %) were diagnosed as having JME. Female to male ratio was 1.7. Age at seizure onset was 15 ± 3.5 years. Generalized tonic-clonic seizures were reported by 225 patients (94.1 %) and absences by 90 (37.6 %). Electroencephalography (EEG) was abnormal in 69.6 % of the patients. JME is one of the most common syndromes of IGEs. The key element in making the correct diagnosis is obtaining a detailed clinical history. MRI or laboratory tests in a patient, in whom you are suspecting JME are not necessary. Even EEG has some limitations and normal or even atypical findings in a patient with typical history for JME should not deter from the correct diagnosis.

Comparison of temporal lobe epilepsy with hippocampal sclerosis and temporal lobe epilepsies due to other etiologies.

BACKGROUND: This study compares the clinical characteristics of patients with mesial temporal lobe epilepsy with hippocampal sclerosis (mTLE-HS) with those who have temporal lobe epilepsy (TLE) due to other etiologies. METHODS: In this retrospective study all patients with a clinical diagnosis of TLE were recruited in a referral outpatient epilepsy clinic at Shiraz University of Medical Sciences from September 2008 to May 2013. We classified the patients with TLE as having mesial temporal sclerosis if they had clear signs of mesial temporal sclerosis and/or atrophy in their MRI and others who had any other MRI abnormality. RESULTS: A total of 174 patients were studied (including 105 patients with mTLE-HS and 69 patients with TLE due to other etiologies). Frequency of seizure types was not significantly different between these two groups. Earlier age at epilepsy onset (p= 0.005), a past history of febrile seizures (p= 0.010) and presence of affective auras (p= 0.008) were commonly seen in patients with mTLEHS, while auditory auras (p= 0.020) were more frequent in those with TLE due to other etiologies. CONCLUSION: The mainstay for making a correct diagnosis, when evaluating a patient with seizure, is having a standardized approach, particularly with regard to taking a detailed clinical history. One may find important clues in the clinical history (e.g., age at disease onset, detailed seizure description and past history) to make a correct diagnosis.

Prolonged psychogenic nonepileptic seizures or pseudostatus.

PURPOSE: The purpose of this study was to determine if patients with episodes of prolonged psychogenic nonepileptic seizures or pseudostatus are different from those with psychogenic nonepileptic seizures (PNESs) without prolonged attacks regarding their demographic and clinical characteristics and factors potentially predisposing to PNESs. METHODS: In this prospective study, all patients with a clinical diagnosis of PNESs (based on ictal recordings) were recruited at the outpatient epilepsy clinic at Shiraz University of Medical Sciences from 2008 through 2013. The epileptologist interviewed all the patients. We compared the demographic and clinical characteristics of patients with PNES-status with those with PNES-only. RESULTS: Two hundred and eleven patients were studied. Forty-nine patients (23.2%) reported episodes of PNES-status, and 162 patients (76.8%) did not report PNES-status. There were no significant differences between these two groups of patients regarding the demographic and clinical characteristics and factors potentially predisposing to PNESs. CONCLUSION: Psychogenic nonepileptic seizure status (PNES-status) is relatively common among patients with PNESs. It seems that patients with PNES-status are not different from those with PNES-only, at least regarding the demographic and clinical characteristics and factors potentially predisposing to PNESs.

Structural, Functional, and Electrical Remodeling of the Atria With Reduced Cardiorespiratory Fitness: Implications for AF.

BACKGROUND: Reduced cardiorespiratory fitness (CRF) is an independent risk factor for the progression of atrial fibrillation (AF). We hypothesized that reduced CRF is associated with structural, functional, and electrical remodeling of the left atrium. OBJECTIVES: This study sought to correlate objectively assessed CRF with functional and electrical left atrial (LA) parameters using invasive and noninvasive assessments. METHODS: Consecutive patients with symptomatic AF undergoing catheter ablation were recruited. CRF was objectively quantified pre-ablation by using cardiopulmonary exercise testing. Using peak oxygen consumption, participants were classified as preserved CRF (>20 mL/kg/min) or reduced CRF (<20 mL/kg/min). LA stiffness was assessed invasively with hemodynamic monitoring and imaging during high-volume LA saline infusion. LA stiffness was calculated as ΔLA diameter/ΔLA pressure over the course of the infusion. LA function was assessed with echocardiographic measures of LA emptying fraction and LA strain. Electrical remodeling was assessed by using high-density electroanatomical maps for LA voltage and conduction. RESULTS: In total, 100 participants were recruited; 43 had reduced CRF and 57 had preserved CRF. Patients with reduced CRF displayed elevated LA stiffness (P = 0.004), reduced LA emptying fraction (P = 0.006), and reduced LA reservoir strain (P < 0.001). Reduced CRF was also associated with reduced LA voltage (P = 0.039) with greater heterogeneity (P = 0.027) and conduction slowing (P = 0.04) with greater conduction heterogeneity (P = 0.02). On multivariable analysis, peak oxygen consumption was independently associated with LA stiffness (P = 0.003) and LA conduction velocities (P = 0.04). CONCLUSIONS: Reduced CRF in patients with AF is independently associated with worse LA disease involving functional and electrical changes. Improving CRF may be a target for restoring LA function in AF.

Exercise echocardiography to assess left atrial function in patients with symptomatic AF.

Background: Left atrial (LA) function contributes to the augmentation of cardiac output during exercise. However, LA response to exercise in patients with atrial fibrillation (AF) is unknown. We explored the LA mechanical response to exercise and the association between LA dysfunction and exercise intolerance. Methods: We recruited consecutive patients with symptomatic AF and preserved left ventricular ejection fraction (LVEF). Participants underwent exercise echocardiography and cardiopulmonary exercise testing (CPET). Two-dimensional and speckle-tracking echocardiography were performed to assess LA function at rest and during exercise. Participants were grouped according to presenting rhythm (AF vs sinus rhythm). The relationship between LA function and cardiorespiratory fitness in patients maintaining SR was assessed using linear regression. Results: Of 177 consecutive symptomatic AF patients awaiting AF ablation, 105 met inclusion criteria; 31 (29.5 %) presented in AF whilst 74 (70.5 %) presented in SR. Patients in SR augmented LA function from rest to exercise, increasing LA emptying fraction (LAEF) and LA reservoir strain. In contrast, patients in AF demonstrated reduced LAEF and reservoir strain at rest, with failure to augment either parameter during exercise. This was associated with reduced VO2Peak compared to those in SR (18.4 ± 5.6 vs 22.5 ± 7.7 ml/kg/min, p = 0.003). In patients maintaining SR, LAEF and reservoir strain at rest and during exercise were associated with VO2Peak, independent of LV function. Conclusion: The maintenance of SR in patients with AF is associated with greater LA reservoir function at rest and greater augmentation with exercise compared to patients in AF. In patients in SR, reduced LA function is associated with reduced exercise tolerance, independent of LV function.

Utility and Validity of the HFA-PEFF and H2FPEF Scores in Patients With Symptomatic Atrial Fibrillation.

BACKGROUND: Diagnosis of heart failure with preserved ejection fraction (HFpEF) in patients with atrial fibrillation (AF) represents a significant clinical challenge. Two diagnostic scoring tools have been developed to aid the noninvasive diagnosis of HFpEF: the HFA-PEFF (Heart Failure Association Pre-test assessment, Echocardiography and natriuretic peptide, Functional testing, Final etiology) and the H2FPEF scoring systems. OBJECTIVES: The purpose of this study was to evaluate the performance of these 2 scoring tools for the diagnosis of HFpEF against a gold standard of invasive evaluation in a cohort of patients with AF. METHODS: The authors recruited consecutive patients with symptomatic AF and preserved ejection fraction who were scheduled for an AF ablation procedure. Gold-standard invasive diagnosis of HFpEF was performed at the AF ablation procedure using mean left atrial pressure at rest and following infusion of 500 mL fluid. Each participant was scored according to the noninvasive HFA-PEFF and H2FPEF scoring systems. Sensitivity and specificity analyses were performed to assess the accuracy of these scoring systems in diagnosing HFpEF. RESULTS: In total, 120 participants were recruited. HFpEF was diagnosed invasively in 88 (73.3%) participants, whereas 32 (26.7%) had no HFpEF. Using the HFA-PEFF score, 38 (31.7%) participants had a high probability of HFpEF and 82 (68.3%) had low/intermediate probability of HFpEF. Using the H2FPEF tool, 72 (60%) participants had a high probability of HFpEF and 48 (40%) had intermediate probability. A high HFA-PEFF (≥5 points) score could diagnose HFpEF with a sensitivity of 40% and a specificity of 91%, and a high H2FPEF score (≥6 points) could diagnose HFpEF with a sensitivity of 69% and specificity of 66%. Overall diagnostic accuracy was similar using both tools (AUC: 0.663 vs 0.707, respectively; P = 0.636). CONCLUSIONS: Against a gold standard of invasively diagnosed HFpEF, the HFA-PEFF and H2FPEF scores demonstrate only moderate accuracy in patients with AF and should be utilized with caution in this cohort of patients. (Characterising Left Atrial Function and Compliance in Atrial Fibrillation; ACTRN12620000639921).

Safety of outpatient commencement of sotalol.

Background: Inpatient monitoring is recommended for sotalol initiation. Objective: The purpose of this study was to assess the safety of outpatient sotalol commencement. Methods: This is a multicenter, retrospective, observational study of patients initiated on sotalol in an outpatient setting. Serial electrocardiogram monitoring at day 3, day 7, 1 month, and subsequently as clinically indicated was performed. Corrected QT (QTc) interval and clinical events were evaluated. Results: Between 2008 and 2023, 880 consecutive patients who were commenced on sotalol were evaluated. Indications were atrial fibrillation/flutter in 87.3% (n = 768), ventricular arrhythmias in 9.9% (n = 87), and other arrhythmias in 2.8% (n = 25). The daily dosage at initiation was 131.0 ± 53.2 mg/d. The QTc interval increased from baseline (431 ± 32 ms) to 444 ± 37 ms (day 3) and 440 ± 33 ms (day 7) after sotalol initiation (P < .001). Within the first week, QTc prolongation led to the discontinuation of sotalol in 4 and dose reduction in 1. No ventricular arrhythmia, syncope, or death was observed during the first week. Dose reduction due to asymptomatic bradycardia occurred in 3 and discontinuation due to dyspnea in 3 within the first week. Overall, 1.1% developed QTc prolongation (>500 ms/>25% from baseline); 4 within 3 days, 1 within 1 week, 4 within 60 days, and 1 after >3 years. Discontinuation of sotalol due to other adverse effects occurred in 41 patients within the first month of therapy. Conclusion: Sotalol initiation in an outpatient setting with protocolized follow-up is safe, with no recorded sotalol-related mortality, ventricular arrhythmias, or syncope. There was a low incidence of significant QTc prolongation necessitating discontinuation within the first month of treatment. Importantly, we observed a small incidence of late QT prolongation, highlighting the need for vigilant outpatient surveillance of individuals on sotalol.

Demographic and clinical manifestations of psychogenic non-epileptic seizures: the impact of co-existing epilepsy in patients or their family members.

PURPOSE: The aim of the current study was to clarify the impact of co-existing epileptic seizures (either in patients themselves or in their family members) on the demographic and clinical characteristics and manifestations of psychogenic non-epileptic seizures (PNES). METHODS: In this prospective study, all patients with a definite diagnosis of PNES were recruited at the epilepsy center at Shiraz University of Medical Sciences from September 2008 through May 2012. We subdivided the patients into three groups: those with PNES but without either epilepsy or a family history of epilepsy (group 1); those with PNES and concomitant epilepsy but without a family history of epilepsy (group 2); and those with PNES and a family history of epilepsy but without concomitant epilepsy (group 3). We studied the demographic and clinical findings and associated risk factors among these three groups. RESULTS: One hundred and eighty-eight patients had confirmed diagnosis of PNES at our center, of whom 32 patients (17%) had confirmed epilepsy. In total, 176 patients met our inclusion criteria and were studied: 103 patients in group 1, 19 patients in group 2, and 54 patients in group 3. Demographic characteristics, seizure characteristics, and semiology in these three groups of patients with PNES were similar. They reported similar associated factors for PNES. CONCLUSION: Epilepsy is relatively common among patients with PNES. The demographic and clinical characteristics of patients with PNES are similar in those with or without co-existing epilepsy (in themselves or among their family members).