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Journal of the American Heart... Feb 2022Background Atrial tachyarrhythmias are common after atrial fibrillation ablation, so adjunctive antiarrhythmic drug therapy is often used. Data on the effectiveness and...
Background Atrial tachyarrhythmias are common after atrial fibrillation ablation, so adjunctive antiarrhythmic drug therapy is often used. Data on the effectiveness and safety of dronedarone and sotalol after AF ablation are limited. Here, we compared health outcomes of ablated patients treated with dronedarone versus sotalol. Methods and Results A comparative analysis of propensity score-matched retrospective cohorts was performed using IBM MarketScan Research Databases. Patients treated with dronedarone after atrial fibrillation ablation were matched 1:1 to patients treated with sotalol between January 1, 2013 and March 31, 2018. Outcomes of interest included cardiovascular hospitalization, proarrhythmia, repeat ablation, and cardioversion. This study was exempt from institutional review board review. Among 30 696 patients who underwent atrial fibrillation ablation, 2086 were treated with dronedarone and 3665 with sotalol after ablation. Propensity-score matching resulted in 1815 patients receiving dronedarone matched 1:1 to patients receiving sotalol. Risk of cardiovascular hospitalization was lower with dronedarone versus sotalol at 3 months (adjusted hazard ratio [aHR], 0.77 [95% CI, 0.61-0.97]), 6 months (aHR, 0.76 [95% CI, 0.63-0.93]), and 12 months after ablation (aHR, 0.70 [95% CI, 0.66-0.93]). Risk of repeat ablation and cardioversion generally did not differ between the 2 groups. A lower risk of proarrhythmia was associated with dronedarone versus sotalol at 3 months (aHR, 0.76 [95% CI, 0.64-0.90]), 6 months (aHR, 0.80 [95% CI, 0.70-0.93]), and 12 months (aHR, 0.83 [95% CI, 0.73-0.94]) after ablation. Conclusions These data suggest that dronedarone may be a more effective and safer alternative after ablation than sotalol.
Topics: Anti-Arrhythmia Agents; Atrial Fibrillation; Catheter Ablation; Dronedarone; Humans; Retrospective Studies; Sotalol
PubMed: 35060388
DOI: 10.1161/JAHA.120.020506 -
Economics and outcomes of sotalol in-patient dosing approaches in patients with atrial fibrillation.Journal of Cardiovascular... Mar 2022There exists variability in the administration of in-patient sotalol therapy for symptomatic atrial fibrillation (AF). The impact of this variability on patient...
INTRODUCTION
There exists variability in the administration of in-patient sotalol therapy for symptomatic atrial fibrillation (AF). The impact of this variability on patient in-hospital and 30-day posthospitalization costs and outcomes is not known. Also, the cost impact of intravenous sotalol, which can accelerate drug loading to therapeutic levels, is unknown.
METHODS
One hundred and thirty-three AF patients admitted for oral sotalol initiation at an Intermountain Healthcare Hospital from January 2017 to December 2018 were included. Patient and dosing characteristics were described descriptively and the impact of dosing schedule was correlated with daily hospital costs/clinical outcomes during the index hospitalization and for 30 days. The Centers for Medicare and Medicaid Services reimbursement for 3-day sotalol initiation is $9263.51. Projections of cost savings were made considering a 1-day load using intravenous sotalol that costs $2500.00 to administer.
RESULTS
The average age was 70.3 ± 12.3 years and 60.2% were male with comorbidities of hypertension (83%), diabetes (36%), and coronary artery disease (53%). The mean ejection fraction was 59.9 ± 7.8% and the median corrected QT interval was 453.7 ± 37.6 ms before sotalol dosing. No ventricular arrhythmias developed, but bradycardia (<60 bpm) was observed in 37.6% of patients. The average length of stay was 3.9 ± 4.6 (median: 2.2) days. Postdischarge outcomes and rehospitalization rates stratified by length of stay were similar. The cost per day was estimated at $2931.55 (1. $2931.55, 2. $5863.10, 3. $8794.65, 4. $11 726.20).
CONCLUSIONS
In-patient oral sotalol dosing is markedly variable and results in the potential of both cost gain and loss to a hospital. In consideration of estimated costs, there is the potential for $871.55 cost savings compared to a 2-day oral load and $3803.10 compared to a 3-day oral load.
Topics: Aftercare; Aged; Aged, 80 and over; Anti-Arrhythmia Agents; Atrial Fibrillation; Humans; Male; Medicare; Middle Aged; Patient Discharge; Sotalol; United States
PubMed: 34953091
DOI: 10.1111/jce.15342 -
Heart Rhythm Jun 2022
Topics: Adenosine; Anti-Arrhythmia Agents; Humans; Sotalol; Tachycardia, Supraventricular
PubMed: 35144018
DOI: 10.1016/j.hrthm.2022.02.002 -
Circulation. Arrhythmia and... Feb 2021Antiarrhythmic drug (AAD) therapy for atrial fibrillation (AF) can be associated with both proarrhythmic and noncardiovascular toxicities. Practice guidelines recommend...
BACKGROUND
Antiarrhythmic drug (AAD) therapy for atrial fibrillation (AF) can be associated with both proarrhythmic and noncardiovascular toxicities. Practice guidelines recommend tailored AAD therapy for AF based on patient-specific characteristics, such as coronary artery disease and heart failure, to minimize adverse events. However, current prescription patterns for specific AADs and the degree to which these guidelines are followed in practice are unknown.
METHODS
Patients enrolled in the Get With The Guidelines-Atrial Fibrillation registry with a primary diagnosis of AF discharged on an AAD between January 2014 and November 2018 were included. We analyzed rates of prescription of each AAD in several subgroups including those without structural heart disease. We classified AAD use as guideline concordant or nonguideline concordant based on 6 criteria derived from the American Heart Association/American College of Cardiology/Heart Rhythm Society AF guidelines. Guideline concordance for amiodarone was not considered applicable, since its use is not specifically contraindicated in the guidelines for reasons such as structural heart disease or renal function. We analyzed guideline-concordant AAD use by specific patient and hospital characteristics, and regional and temporal trends.
RESULTS
Among 21 921 patients from 123 sites, the median age was 69 years, 46% female and 51% had paroxysmal AF. The most commonly prescribed AAD was amiodarone (38%). Sotalol (23.2%) and dofetilide (19.2%) were each more commonly prescribed than either flecainide (9.8%) or propafenone (4.8%). Overall guideline-concordant AAD prescription at discharge was 84%. Guideline-concordant AAD use by drug was as follows: dofetilide 93%, sotalol 66%, flecainide 68%, propafenone 48%, and dronedarone 80%. There was variability in rate of guideline-concordant AAD use by hospital and geographic region.
CONCLUSIONS
Amiodarone remains the most commonly prescribed AAD for AF followed by sotalol and dofetilide. Rates of guideline-concordant AAD use were high, and there was significant variability by specific drugs, hospitals, and regions, highlighting opportunities for additional quality improvement.
Topics: Aged; Anti-Arrhythmia Agents; Atrial Fibrillation; Female; Follow-Up Studies; Guideline Adherence; Humans; Male; Middle Aged; Registries; Retrospective Studies
PubMed: 33419385
DOI: 10.1161/CIRCEP.120.008961 -
Heart Rhythm Jul 2024Loading of oral sotalol for atrial fibrillation requires 3 days, frequently in the hospital, to achieve steady state. The Food and Drug Administration approved loading... (Observational Study)
Observational Study
BACKGROUND
Loading of oral sotalol for atrial fibrillation requires 3 days, frequently in the hospital, to achieve steady state. The Food and Drug Administration approved loading with intravenous (IV) sotalol through model-informed development, without patient data.
OBJECTIVE
We present results of the first multicenter evaluation of this recent labeling for IV sotalol.
METHODS
The Prospective Evaluation Analysis and Kinetics of IV Sotalol (PEAKS) Registry was a multicenter observational registry of patients undergoing elective IV sotalol load for atrial arrhythmias. Outcomes, measured from hospital admission until first outpatient follow-up, included adverse arrhythmia events, efficacy, and length of stay.
RESULTS
Of 167 consecutively enrolled patients, 23% were female; the median age was 68 (interquartile range, 61-74) years, and the median CHADS-VASc score was 3 (interquartile range, 2-4). Overall, 99% were admitted for sotalol initiation (1% for dose escalation), with a target oral sotalol dose of either 80 mg twice daily (85 [51%]) or 120 mg twice daily (78 [47%]); 62 patients (37%) had an estimated creatinine clearance ≤90 mL/min. On presentation, 40% of patients were in sinus rhythm, whereas 26% underwent cardioversion before sotalol infusion. In 2 patients, sotalol infusion was stopped for bradycardia or hypotension. In 6 patients, sotalol was discontinued before discharge because of QTc prolongation (3), bradycardia (1), or recurrent atrial arrhythmia (2). The mean length of stay was 1.1 days, and 95% (n = 159) were discharged within 1 night.
CONCLUSION
IV sotalol loading is safe and feasible for atrial arrhythmias, with low rates of adverse events, and yields shorter hospitalizations. More data are needed on the minimal duration required for monitoring in the hospital.
Topics: Humans; Sotalol; Female; Male; Atrial Fibrillation; Middle Aged; Anti-Arrhythmia Agents; Registries; Aged; Prospective Studies; Dose-Response Relationship, Drug; Treatment Outcome; Infusions, Intravenous; Administration, Intravenous; Follow-Up Studies
PubMed: 38417598
DOI: 10.1016/j.hrthm.2024.02.046 -
International Journal of Molecular... Jan 2023Fetal arrhythmia develops in 0.1-5% of pregnancies and may cause fetal heart failure and fetal hydrops, thus increasing fetal, neonatal, and infant mortality. The timely...
Fetal arrhythmia develops in 0.1-5% of pregnancies and may cause fetal heart failure and fetal hydrops, thus increasing fetal, neonatal, and infant mortality. The timely initiation of transplacental antiarrhythmic therapy (ART) promotes the conversion of fetal tachycardia to sinus rhythm and the regression of the concomitant non-immune fetal hydrops. The optimal treatment regimen search for the fetus with tachyarrhythmia is still of high value. Polymorphisms of these genes determines the individual features of the drug pharmacokinetics. The aim of this study was to study the pharmacokinetics of transplacental anti-arrhythmic drugs in the fetal therapy of arrhythmias using HPLC-MS/MS, as well as to assess the effect of the multidrug-resistance gene 3435C > T polymorphism on the efficacy and maternal/fetal complications of digoxin treatment. The predisposition to a decrease in the bioavailability of the digoxin in patients with a homozygous variant of the CC polymorphism showed a probable association with the development of ART side effects. A pronounced decrease in heart rate in women with the 3435TT allele of the gene was found. The homozygous TT variant in the fetus showed a probable association with an earlier response to ART and rhythm disruptions on the digoxin dosage reduction. high-performance liquid chromatography with tandem mass spectrometry (HPLC-MS/MS) methods for digoxin and sotalol therapeutic drug monitoring in blood plasma, amniotic fluid, and urine were developed. The digoxin and sotalol concentrations were determined in the plasma blood, urine, and amniotic fluid of 30 pregnant women at four time points (from the beginning of the transplacental antiarrhythmic therapy to delivery) and the plasma cord blood of 30 newborns. A high degree of correlation between the level of digoxin and sotalol in maternal and cord blood was found. The ratio of digoxin and sotalol in cord blood to maternal blood was 0.35 (0.27 and 0.46) and 1.0 (0.97 and 1.07), accordingly. The digoxin concentration in the blood of the fetus at the moment of the first rhythm recovery episode, 0.58 (0.46, 0.8) ng/mL, was below the therapeutic interval. This confirms the almost complete transplacental transfer of sotalol and the significant limitation in the case of digoxin. Previously, ABCB1/P-glycoprotein had been shown to limit fetal exposure to drugs. Further studies (including multicenter ones) to clarify the genetic features of the transplacental pharmacokinetics of antiarrhythmic drugs are needed.
Topics: Female; Humans; Infant, Newborn; Pregnancy; Amniotic Fluid; Anti-Arrhythmia Agents; Arrhythmias, Cardiac; Chromatography, High Pressure Liquid; Digoxin; Drug Monitoring; Hydrops Fetalis; Pregnant Women; Sotalol; Tachycardia; Tachycardia, Supraventricular; Tandem Mass Spectrometry
PubMed: 36768172
DOI: 10.3390/ijms24031848 -
Journal of Cardiovascular... Dec 2021Pharmacological cardioversion using intravenous antiarrhythmic agents is commonly indicated in symptomatic patients with recent-onset atrial fibrillation (AF). Except in... (Review)
Review
Pharmacological cardioversion using intravenous antiarrhythmic agents is commonly indicated in symptomatic patients with recent-onset atrial fibrillation (AF). Except in hemodynamically unstable patients who require emergency direct current electrical cardioversion, for the majority of hemodynamically stable patients, pharmacological cardioversion represents a valid option and requires the clinician to be familiar with the properties and use of antiarrhythmic agents. The main characteristics of selected intravenous antiarrhythmic agents for conversion of recent-onset AF, the reported success rates, and possible adverse events are discussed. Among intravenous antiarrhythmics, flecainide, propafenone, amiodarone, sotalol, dofetilide, ibutilide, and vernakalant are commonly used. Antazoline, an old antihistaminic agent with antiarrhythmic properties was also reported to give encouraging results in Poland. Intravenous flecainide and propafenone are the only Class I agents still recommended by recent guidelines. Intravenous new Class III agents as dofetilide and ibutilide have high and rapid efficacy in converting AF to sinus rhythm but require strict surveillance with electrocardiogram (ECG) monitoring during and after intravenous administration because of the potential risk of QT prolongation and Torsades de Pointes, which can be prevented and properly managed. Vernakalant, a partial atrial selective was shown to have a high success rate and to be safe in real-life use.
Topics: Administration, Intravenous; Amiodarone; Anti-Arrhythmia Agents; Atrial Fibrillation; Electric Countershock; Humans
PubMed: 34662471
DOI: 10.1111/jce.15264 -
Journal of Comparative Effectiveness... Aug 2023To evaluate the clinical and economic impact of antiarrhythmic drugs (AADs) compared with ablation both as individual treatments and as combination therapy without/with...
To evaluate the clinical and economic impact of antiarrhythmic drugs (AADs) compared with ablation both as individual treatments and as combination therapy without/with considering the order of treatment among patients with atrial fibrillation (AFib). A budget impact model over a one-year time horizon was developed to assess the economic impact of AADs (amiodarone, dofetilide, dronedarone, flecainide, propafenone, sotalol, and as a group) versus ablation across three scenarios: direct comparisons of individual treatments, non-temporal combinations, and temporal combinations. The economic analysis was conducted in accordance with CHEERS guidance as per current model objectives. Results are reported as costs per patient per year (PPPY). The impact of individual parameters was evaluated using one-way sensitivity analysis (OWSA). In direct comparisons, ablation had the highest annual medication/procedure cost ($29,432), followed by dofetilide ($7661), dronedarone ($6451), sotalol ($4552), propafenone ($3044), flecainide ($2563), and amiodarone ($2538). Flecainide had the highest costs for long-term clinical outcomes ($22,964), followed by dofetilide ($17,462), sotalol ($15,030), amiodarone ($12,450), dronedarone ($10,424), propafenone ($7678) and ablation ($9948). In the non-temporal scenario, total costs incurred for AADs (group) + ablation ($17,278) were lower compared with ablation alone ($39,380). In the temporal scenario, AADs (group) before ablation resulted in PPPY cost savings of ($22,858) compared with AADs (group) after ablation ($19,958). Key factors in OWSA were ablation costs, the proportion of patients having reablation, and withdrawal due to adverse events. Utilization of AADs as individual treatment or in combination with ablation demonstrated comparable clinical benefits along with costs savings in patients with AFib.
Topics: Humans; Atrial Fibrillation; Anti-Arrhythmia Agents; Dronedarone; Sotalol; Propafenone; Flecainide; Amiodarone
PubMed: 37387403
DOI: 10.57264/cer-2023-0065 -
Clinical Case Reports Sep 2019We present a patient with end-stage hypertrophic cardiomyopathy who was suffering from ocular and generalized forms of myasthenia gravis as an uncommon neurological...
We present a patient with end-stage hypertrophic cardiomyopathy who was suffering from ocular and generalized forms of myasthenia gravis as an uncommon neurological complication of sotalol. This case report warns clinicians to maintain caution over rare side effects of medication, which could be confused with the clinical symptoms of the underlying disease.
PubMed: 31534771
DOI: 10.1002/ccr3.2341 -
Environmental Research Nov 2022β-blockers are widely used chiral pharmaceuticals to treat hypertension and cardiovascular diseases, which are ubiquitously detected in the water-soil environment....
β-blockers are widely used chiral pharmaceuticals to treat hypertension and cardiovascular diseases, which are ubiquitously detected in the water-soil environment. However, little is known about their biogeochemical behaviors and enantiomer selectivity during soil migration and transformation. In this study, the adsorption and leaching behaviors of β-blockers in fluvo-aquic soil and black soil were investigated. The adsorption of β-blockers was fit well by the Freundlich adsorption isotherm (R > 0.913) and the adsorption affinity of β-blockers decreased in the following order: propranolol (logarithm of Freundlich adsorption coefficient log K = 1.46-2.55) > atenolol (log K = 0.53-1.04) > sotalol (log K = 0.32-1.01). An increase in ionic strength and dissolved organic matter (DOM) inhibited their soil adsorption. Ionic change is the main driving force for adsorption. Besides, hydrophobic partitioning and hydrogen bonding played key roles in the adsorption of propranolol and atenolol, respectively. The leaching behaviors of β-blockers are related to their hydrophobicity. An increase in ionic strength enhanced the migration of β-blockers to deeper soil layers, and the presence of DOM accelerated the migration of sotalol and propranolol. The migration potential of β-blockers in black soil is lower than that in fluvo-aquic soil, which could be ascribed to the higher organic matter content and strong ion exchange ability of black soil. Further, more significant enantiomer selectivity of β-blockers was found in black soil (e.g. enantiomer fraction of atenolol = 0.61) than in fluvo-aquic soil (e.g. enantiomer fraction of atenolol = 0.53) during the leaching process. The microbial activity might influence the enantiomer selectivity of studied β-blockers during soil leaching.
Topics: Adsorption; Atenolol; Propranolol; Soil; Soil Pollutants; Sotalol
PubMed: 35961549
DOI: 10.1016/j.envres.2022.114062