Figure 5 - uploaded by Alexander Spiel
Content may be subject to copyright.
Mean QT interval (A) and QTcF interval (B) over 6 h after administration of first study drug infusion. Absolute values and mean change from baseline within 360 min after administration of first study drug infusion. (B) Mean QT interval corrected for heart rate using Fridericia's formula.

Mean QT interval (A) and QTcF interval (B) over 6 h after administration of first study drug infusion. Absolute values and mean change from baseline within 360 min after administration of first study drug infusion. (B) Mean QT interval corrected for heart rate using Fridericia's formula.

Source publication
Article
Full-text available
Aims Ibutilide is a rapid-acting antiarrhythmic drug with worldwide use for conversion of recent-onset atrial fibrillation. Vernakalant, approved in the EU in 2010, is likewise used intravenously, with proven efficacy and safety compared with placebo and amiodarone in randomized clinical trials. The aim of our study was to compare the time to conve...

Context in source publication

Context 1
... systolic and diastolic blood pressure decreased within both groups ( Figure 4); however, in patients receiving vernakalant, a slight initial increase in diastolic blood pressure occurred within the first 20 -40 min after application of first study drug dose. In both groups, QTcF increased, however, significantly more pronounced in the ibutilide group ( Figure 5). ...

Similar publications

Article
Full-text available
Atrial fibrillation (AF) is one of the most common rhythm disorders observed in clinical practice and is predominantly associated with coronary heart disease and hypertension. However, different classes of drugs may induce AF as a side effect in patients without apparent heart disease or they may precipitate the onset of AF in patients with preexis...
Article
Full-text available
Photoplethysmography (PPG) signal is potentially suitable in atrial fibrillation (AF) detection for its convenience in use and similarity in physiological origin to electrocardiogram (ECG). There are a few preceding studies that have shown the possibility of using the peak-to-peak interval of the PPG signal (PPIp) in AF detection. However, as a gen...
Article
Full-text available
A case of electrical cardioversion of long-standing persistent atrial fibrillation (AF) is presented along with tips and tricks for a successful strategy to restore and maintain sinus rhythm. Rhythmos 2020; 15(3):52-54.
Article
Full-text available
Background Patients with persistent atrial fibrillation (AF) have more electrical endo-epicardial asynchrony (EEA) during sinus rhythm (SR) than patients without AF. Prior mapping studies indicated that particularly unipolar, endo- and/or epicardial electrogram (EGM) morphology may be indicators of EEA. This study aim to develop a novel method for...
Article
Full-text available
Background and Objectives: Atrial fibrillation is a common abnormal cardiac rhythm caused by disorganized electrical impulses. AF which is refractory to antiarrhythmic management is often treated with catheter ablation. Recently a novel ablation system (nMARQ) was introduced for PV isolation. However, there has not been a systematic review of its e...

Citations

... [15]. Bradycardia was also seen in the SPECTRUM study (0.5%), the superiority study comparing vernakalant and ibutilide, where 2 out of 49 (4.1%) had bradycardia, and the study by Rudiger et al. on critically ill patients, where 2 of their 32 patients (6.25%) experienced bradycardia [16,23,24]. In the latter study, 11 patients (34%) experienced hypotension, and 0.1% experienced hypotension in the SPECTRUM study, with this SAE not recorded in our study as previously mentioned [23,24]. ...
... et al. demonstrated vernakalant's superior role in sinus rhythm restoration compared to ibutilide (69% versus 43%), while the study by Pohjantahti-Maaroos et al. demonstrated its superior role in restoring rhythm compared to flecainide (67% vs. 46%)[16,17].As for studies comparing conversion rates to sinus rhythm in patients receiving vernakalant versus those receiving a placebo, results showed rates of 37.6% and 2.6%, respectively, in the phase III randomized placebo-controlled trial by Roy et al., 47% and 14%, respectively, in the randomized, double-blind, placebocontrolled trial of noncritically ill patients having AF after cardiac surgery by Kowey et al., 45.7% and 1.5%, respectively, in the phase 3b randomized controlled trial by Beatch and Mangal, 53% and 5%, respectively, in the randomized controlled trial by Roy et al., and 39.8% and 3.3%, respectively, in the study by Pratt et al.[18][19][20][21][22].Concerning safety and severe adverse effects (SAE), 4 of our 23 patients (17.4%) experienced bradycardia, 4 (17.4%) experienced AV block, and 2 (8.7%) experienced QT prolongation from baseline. ...
Article
Full-text available
Background: We use vernakalant, an intravenous anti-arrhythmic, to cardiovert paroxysmal atrial fibrillation (AF) into sinus rhythm. It is a relatively atrium-selective, early-activating potassium and frequency- dependent sodium channel blocker with a half-life of 2 to 3 hours. Due to concerns regarding its safety profile, it is not Food and Drug Administration (FDA)-approved. Objective: This study aims to assess the efficacy of intravenous vernakalant in cardioversion of paroxysmal AF and the safety of its use. Methods: Patients with paroxysmal AF who presented to the American University of Beirut Medical Center (AUBMC) between 2015 and 2020 and received vernakalant for cardioversion were included. Patients did not receive vernakalant if they had any of the following: QTc > 440 ms, heart rate < 50 bpm, acute coronary syndrome within the last 30 days, second- and third-degree atrioventricular (AV) block in the absence of a pacemaker, severe aortic stenosis (AS), use of intravenous antiarrhythmics (class I and class III) within four hours of vernakalant infusion, systolic blood pressure <100 mmHg, and heart failure (New York Heart Association (NYHA) III or NYHA IV class). The primary endpoint is conversion to sinus rhythm for at least one minute within 90 minutes of the start of the vernakalant infusion. The secondary endpoint included the presence of these side effects: bradycardia, QTc prolongation, AV block, ventricular arrhythmias, hypotension, taste alteration/dysgeusia, sneezing, nausea, vomiting, paresthesia, cardiogenic shock, or death. Results: The study included 23 patients with paroxysmal AF (15 men, mean age 54 ± 14 years). Fourteen patients (61%) cardioverted to sinus rhythm within 90 minutes of the start of the Vernakalant infusion. Seven patients (30%) reverted to sinus rhythm within 15 minutes after the first infusion. After treatment with vernakalant, four patients (17%) developed sinus bradycardia, and four patients (17%) developed first- degree AV block. No patient had a QTc greater than 460 ms. None of the patients experienced sinus pauses, high-grade AV block, ventricular arrhythmias, hypotension, dysgeusia, sneezing, nausea, vomiting, paresthesia, cardiogenic shock, or death. Conclusion: Vernakalant had 61% efficacy in the rapid cardioversion of paroxysmal AF to sinus rhythm, was well tolerated, and had a low rate of adverse events in our study population.
... In our NMA, sustained ventricular tachydysrhythmia occurred in five of 278 participants given ibutilide, a rate similar to those reported in other prospective, observational studies [97,98]. High doses of intravenous magnesium may reduce the risk of sustained ventricular tachydysrhythmia associated with ibutilide infusion [97], but only one [56] of four ibutilide trials in the network administered magnesium and only supplementation, not prophylactic, doses prior to ibutilide administration. There were no ventricular tachydysrhythmia events reported among subjects given propafenone (intravenous or oral), flecainide (intravenous or oral), or vernakalant. ...
Article
Full-text available
Purpose: The available evidence to determine which antidysrhythmic drug is superior for pharmacologic cardioversion of recent-onset (onset within 48 hours) atrial fibrillation (AF) is uncertain. We aimed to identify the safest and most effective agent for pharmacologic cardioversion of recent-onset AF in the emergency department. Methods: We searched MEDLINE, Embase, and Web of Science from inception to February 21, 2023 (PROSPERO: CRD42018083781). Eligible studies were randomized controlled trials that enrolled adult participants with AF ≤ 48 hours, compared a guideline-recommended antidysrhythmic drug with another antidysrhythmic drug or a different formulation of the same drug or placebo and reported specific adverse events. The primary outcome was immediate, serious adverse event – cardiac arrest, sustained ventricular tachydysrhythmia, atrial flutter 1:1 atrioventricular conduction, hypotension, and bradycardia. Additional analyses included the outcomes of conversion to sinus rhythm within 4 hours and 24 hours. We extracted data according to PRISMA-NMA and appraised trials using Cochrane RoB 2. We performed Bayesian network meta-analysis (NMA) using a Markov Chain Monte Carlo method with random-effects model and vague prior distribution to calculate odds ratios with 95% credible intervals. We assessed confidence using CINeMA. We used surface under the cumulative ranking curve (SUCRA) to rank agents. Results: The systematic review initially identified 5,545 studies. Twenty-five studies met eligibility criteria, and 22 studies (n=3,082) provided data for NMA, which demonstrated that vernakalant (SUCRA=70.9%) is most likely to be safest. Additional effectiveness NMA demonstrated that flecainide (SUCRA=89.0%) is most likely to be superior for conversion within 4 hours (27 studies; n=2,681), and ranolazine-amiodarone IV (SUCRA 93.7%) is most likely to be superior for conversion within 24 hours (24 studies; n=3,213). Confidence in the NMA estimates is variable and limited mostly by within-study bias and imprecision. Conclusions: Among guideline-recommended antidysrhythmic drugs, the combination of digoxin IV and amiodarone IV is definitely among the least safe for cardioversion of recent onset AF; flecainide, vernakalant, ibutilide, propafenone, and amiodarone IV are definitely among the most effective for cardioversion within 4 hours; flecainide is definitely among the most effective for cardioversion within 24 hours. Further, randomized controlled trials with predetermined and strictly defined, hemodynamic adverse event outcomes are recommended.
... We previously observed a success rate of 65% in structurally-healthy atria (Dasí et al., 2022). The latter J Physiol 601.18 results are consistent with a randomized clinical trial conducted in patients with recent-onset AF (Simon et al., 2017), reporting an efficacy of 69% (34/49 patients). As in the present study, lower rates, such as 37% (81/221 patients) (Roy et al., 2008), 46% (59/129 patients) (Beatch & Mangal, 2016) and 52% (60/116 patients) (Camm et al., 2011), were obtained when additionally considering persistent AF patients, reflective of more advanced AF substrate. ...
Article
Full-text available
The best pharmacological treatment for each atrial fibrillation (AF) patient is unclear. We aim to exploit AF simulations in 800 virtual atria to identify key patient characteristics that guide the optimal selection of anti‐arrhythmic drugs. The virtual cohort considered variability in electrophysiology and low voltage areas (LVA) and was developed and validated against experimental and clinical data from ionic currents to ECG. AF sustained in 494 (62%) atria, with large inward rectifier K⁺ current (IK1) and Na⁺/K⁺ pump (INaK) densities (IK1 0.11 ± 0.03 vs. 0.07 ± 0.03 S mF–1; INaK 0.68 ± 0.15 vs. 0.38 ± 26 S mF–1; sustained vs. un‐sustained AF). In severely remodelled left atrium, with LVA extensions of more than 40% in the posterior wall, higher IK1 (median density 0.12 ± 0.02 S mF–1) was required for AF maintenance, and rotors localized in healthy right atrium. For lower LVA extensions, rotors could also anchor to LVA, in atria presenting short refractoriness (median L‐type Ca²⁺ current, ICaL, density 0.08 ± 0.03 S mF–1). This atrial refractoriness, modulated by ICaL and fast Na⁺ current (INa), determined pharmacological treatment success for both small and large LVA. Vernakalant was effective in atria presenting long refractoriness (median ICaL density 0.13 ± 0.05 S mF–1). For short refractoriness, atria with high INa (median density 8.92 ± 2.59 S mF–1) responded more favourably to amiodarone than flecainide, and the opposite was found in atria with low INa (median density 5.33 ± 1.41 S mF–1). In silico drug trials in 800 human atria identify inward currents as critical for optimal stratification of AF patient to pharmacological treatment and, together with the left atrial LVA extension, for accurately phenotyping AF dynamics. image Key points Atrial fibrillation (AF) maintenance is facilitated by small L‐type Ca²⁺ current (ICaL) and large inward rectifier K⁺ current (IK1) and Na⁺/K⁺ pump. In severely remodelled left atrium, with low voltage areas (LVA) covering more than 40% of the posterior wall, sustained AF requires higher IK1 and rotors localize in healthy right atrium. For lower LVA extensions, rotors can also anchor to LVA, if the atria present short refractoriness (low ICaL) Vernakalant is effective in atria presenting long refractoriness (high ICaL). For short refractoriness, atria with fast Na⁺ current (INa) up‐regulation respond more favourably to amiodarone than flecainide, and the opposite is found in atria with low INa. The inward currents (ICaL and INa) are critical for optimal stratification of AF patient to pharmacological treatment and, together with the left atrial LVA extension, for accurately phenotyping AF dynamics.
... Other ED-based trials have addressed more specific questions of AF management among subpopulations of ED AF patients, e.g., rapidity of rate reduction (intravenous diltiazem vs intravenous metoprolol) [72,73], method of cardioversion (pharmacologic vs electrical) [129,130], medication of cardioversion (e.g., intravenous vernakalant vs intravenous ibutilide) [131], timing of cardioversion (early vs delayed) [82,83], and location of acute management (observation unit vs inpatient ward) [132]. ...
Article
Full-text available
Background Management of adults with atrial fibrillation (AF) or atrial flutter in the emergency department (ED) includes rate reduction, cardioversion, and stroke prevention. Different approaches to these components of care may lead to variation in frequency of hospitalization and stroke prevention actions, with significant implications for patient experience, cost of care, and risk of complications. Standardization using evidence-based recommendations could reduce variation in management, preventable hospitalizations, and stroke risk. Methods We describe the rationale for our ED-based AF treatment recommendations. We also describe the development of an electronic clinical decision support system (CDSS) to deliver these recommendations to emergency physicians at the point of care. We implemented the CDSS at three pilot sites to assess feasibility and solicit user feedback. We will evaluate the impact of the CDSS on hospitalization and stroke prevention actions using a stepped-wedge cluster randomized pragmatic clinical trial across 13 community EDs in Northern California. Discussion We hypothesize that the CDSS intervention will reduce hospitalization of adults with isolated AF or atrial flutter presenting to the ED and increase anticoagulation prescription in eligible patients at the time of ED discharge and within 30 days. If our hypotheses are confirmed, the treatment protocol and CDSS could be recommended to other EDs to improve management of adults with AF or atrial flutter. Trial registration ClinicalTrials.gov NCT05009225. Registered on 17 August 2021.
... These results are similar to other studies where patients with recent-onset AF received vernakalant in the ED (66-84% effectiveness on restoring SR; online suppl. S6) [10,16,[20][21][22][23]. However, lower SR restoration rates (approximately 50%) were observed in patients with recent-onset AF in previous phase 3 clinical trials, in which AF durations up to 48 h [24] or 7 days [25,26] were accepted. ...
... Vernakalant was also more effective in achieving rapid cardioversion and was associated with shorter hospital stays than flecainide in a non-randomized study [9]. A randomized study has also shown that vernakalant was superior to ibutilide in terms of 90-min cardioversion rate (69 vs. 43%) and median time to conversion (10 min vs. 26 min) [22]. Another randomized study did not confirm the higher cardioversion rate in patients treated with vernakalant versus ibutilide (52.8 vs. 52.4%), ...
Article
Full-text available
Introduction: Intravenous vernakalant is a therapeutic option for symptomatic, recent-onset atrial fibrillation (AF). This secondary analysis from the large SPECTRUM study assessed the safety and effectiveness of vernakalant when used in the emergency department setting (ED group) or in an inpatient hospital setting (non-ED group). Methods: This post hoc analysis of the international, observational, post-authorization SPECTRUM study included 1,289 and 720 recent-onset AF episodes in adults in the ED and non-ED groups, respectively. Safety endpoints included the evaluation of pre-defined health outcomes of interest (HOIs) and other serious adverse events (SAEs) during vernakalant treatment and during the first 24 h after the last infusion. Effectiveness endpoints comprised the rate of successful vernakalant cardioversion, the time from the start of the vernakalant infusion to cardioversion, and the length of hospital stay. Data were analysed using descriptive statistics. Results: The safety profile of vernakalant was similar in the ED and non-ED groups. In the ED group, 12 pre-defined HOIs were reported in 11 patients (0.9%); all but one occurred within 2 h after start of the first infusion. These events comprised nine significant bradycardia cases, of which one was associated with transient hypotension and three with sinus arrest, and 2 cases of atrial flutter with 1:1 conduction. Five other SAEs were reported. All patients with vernakalant-related events recovered without sequelae. No Torsade de Pointes, ventricular fibrillation, or deaths occurred. Successful cardioversion was reported in 67.8% (95% confidence interval: 65.2-70.4) and 66.4% (62.5-70.1) of episodes, with a median time to conversion of 11.0 and 10.0 min in the ED and non-ED groups, respectively. Patients had a median length of hospital stay of 7.4 h and 17.1 h in the ED and non-ED groups, respectively. Conclusion: Intravenous vernakalant was well tolerated with similar cardioversion rates in patients treated in the ED or non-ED setting and does not require admission to a coronary care unit or intensive care unit. First-line treatment with vernakalant could allow an early discharge in patients with recent-onset AF treated in the ED.
... In an RCT comparing Vernakalant and Ibutilide, Simon et al. [8] observed higher conversion rates in the Vernakalant group. However, AFL episodes were excluded due to lacking effect of Vernakalant on this arrhythmia-especially when compared to Ibutilide [9]. ...
... Ibutilide is known to be more effective in AFL than in AF [8][9][10]. Therefore, we analyzed conversion success considering the first detected ECG rhythm in both subpopulations. ...
... Of note, we found high conversion rates in both groups compared to other studies that analyzed the effectiveness of the drugs used for cardioversion [8,12]. The ED setting might be a reason for this controversy, since ED populations show a higher rate of new-onset AF and, therefore, shorter time intervals from AF onset to drug administration than a general AF population [9,13]. ...
Article
Full-text available
Aim: Medication for the pharmacological cardioversion of atrial fibrillation (AF) and atrial flutter (AFL) is applied either in a fixed dose or adapted to body weight. Individual body weight might be a relevant confounder for anti-arrhythmic treatment success. Therefore, the aim of this study was to elucidate the impact of body weight on pharmacological cardioversion success, comparing weight adapted (Vernakalant) and fixed dose (Ibutilide) pharmacotherapeutic cardioversion regimes. Methods: Within this prospective observational trial, a total of 316 episodes of AF and AFL were enrolled. Patients were stratified in either a Vernakalant (n = 181) or Ibutilide (n = 135) treatment arm, based on the chosen regime, for direct comparison of treatment efficacy. Results: Conversion to sinus rhythm was achieved in 76.3% of all cases. Of note, there was no difference comparing the Vernakalant and Ibutilide treatment arms (Vernakalant 76.2% vs. Ibutilide 76.3%; p = 0.991). Within the whole study population, decreasing conversion rates with increasing body weight (adjusted odds ratio (OR) = 0.69 (0.51-0.94); p = 0.018) were observed. An independent effect of body weight within the Ibutilide treatment arm was noted, which remained stable after adjustment for potential confounders (adjusted OR = 0.55 (0.38-0.92), p = 0.022. Conclusion: Both, the Vernakalant and Ibutilide treatment arms showed comparable rates of treatment success in pharmacotherapeutic cardioversion of AF and AFL. Of utmost importance, we observed that the fixed dose of Ibutilide-as compared to the weight-adapted dose of Vernakalant-showed a reduced treatment success with increasing body weight.
... 2018 ESC/ESH, 2020 ESC guideline also raised the importance of hypertension and structural heart disease as contributors to atrial fibrillation development (28)(29)(30). Therefore, the selection of anti-arrhythmic drugs should be based on concomitant structural or functional heart disease (11,(47)(48)(49)(50). However, there was scarce evidence of comparing efficacy and safety for early cardioversion across the concomitant structural disease in patients with recent-onset atrial fibrillation (47). ...
Article
Full-text available
Background Whether early pharmacologic cardioversion is necessary for recent-onset atrial fibrillation is still controversial. Current meta-analyses were limited to evaluating the effects within 24 h without sufficient considering longer follow-up outcomes. We aimed to compare the effect of early pharmacologic cardioversion and non-early cardioversion in patients with recent-onset atrial fibrillation within 4-weeks of follow-up. Methods We searched the Cochrane Library, EMBASE, MEDLINE, PubMed, Web of Science, ClinicalTrials.gov, and Clinicaltrialsregister. eu for randomized controlled trials (RCTs) published before November 2021 comparing early pharmacologic cardioversion and non-early cardioversion in recent-onset atrial fibrillation and synthesized data in accordance with PRISMA-Systematic Reviews and Network Meta-Analysis (NMA). Early pharmacological cardioversion referred to immediate cardioversion with antiarrhythmic drugs (i.e., amiodarone, propafenone, flecainide, tedisamil, vernakalant, vanoxerine, and sotalol) upon admission, while non-early cardioversion involved the administration of rate-control or placebo medication without immediate cardioversion. Results 16 RCTs with 2,395 patients were included. Compared to non-early cardioversion, a systematic review showed that early pharmacologic cardioversion resulted in a higher probability of sinus rhythm maintenance within 24 h (odds ratios [OR] 2.50, 95% credible interval [CrI] 1.76 to 3.54) and 1-week (2.50, 1.76 to 3.54), however, there was no significant difference in sinus rhythm maintenance within 4-weeks (1.37, 0.90 to 2.09). In subgroup analysis, the Bayesian NMA revealed that vernakalant may be successful in sinus rhythm maintenance within both 24 h (3.55, 2.28 to 5.55) and 1-week (2.72, 1.72 to 4.31). The results were consistent with the frequentist NMA. Conclusions Non-early pharmacologic cardioversion may not be inferior to early cardioversion within a 4-week follow-up period in patients with recent-onset atrial fibrillation. The evidence remains insufficient to determine which antiarrhythmic agent is optimal in the longer run. Further high-quality relevant RCTs are necessary. Clinical Trial Registration PROSPERO CRD42020166862.
... En los pacientes hemodinámicamente estables se puede optar por administrar flecainida, propafenona o vernakalant siempre que el paciente no presente cardiopatía isquémica ni cardiopatía estructural [455][456][457] , y en caso contrario se debe optar por la amiodarona 458-460 . 146. ...
Article
Full-text available
The ERAS guidelines are intended to identify, disseminate and promote the implementation of the best, scientific evidence-based actions to decrease variability in clinical practice. The implementation of these practices in the global clinical process will promote better outcomes and the shortening of hospital and critical care unit stays, thereby resulting in a reduction in costs and in greater efficiency. After completing a systematic review at each of the points of the perioperative process in cardiac surgery, recommendations have been developed based on the best scientific evidence currently available with the consensus of the scientific societies involved.
... Current guidelines recommend that the choice of specific drug should be based on the presence, type, and severity of underlying structural (or functional) cardiac disease. Intravenous vernakalant may be administered in mild to moderate heart failure and stable ischemic heart disease ideally after performing bedside echocardiography [34,35,40,55,58,59,62,67,71,72]. Indeed, reviewing all ten available studies, incidence of significant arrhythmic events proved to be low (1-3%). ...
Article
Full-text available
PurposeWe sought to indirectly compare and rank antiarrhythmic agents focusing exclusively on adults with paroxysmal atrial fibrillation in order to identify the most effective for pharmacologic cardioversion over different time settings (4 h as primary, and 12, 24 h as secondary outcomes).Methods We searched several databases from inception to March 2020 without language restrictions, ClinicalTrials.gov, references of reviews, and meeting abstract material. We included randomized controlled trials of patients with AF lasting ≤7 days comparing either two or more intravenous (i.v.) or oral (p.o.) pharmacologic cardioversion agents or an agent against placebo. For each outcome, we performed network meta-analysis based on the frequentist approach.ResultsForty-one trials (6013 patients) were included in our systematic review. Moderate confidence evidence suggests that i.v. vernakalant and flecainide have the highest conversion rate within 4 h, possibly allowing discharge from the emergency department and reducing hospital admissions. Intravenous and p.o. formulations of class IC antiarrhythmics (flecainide more so than propafenone) are superior regarding conversion rates within 12 h, while amiodarone efficacy is exhibited in a delayed fashion (within 24 h), especially if ranolazine is added.Conclusion Our network meta-analysis identified with sufficient power and consistency the most effective antiarrhythmics for pharmacologic cardioversion over different time settings, with vernakalant and flecainide exhibiting a safer and more efficacious profile toward faster cardioversion.Graphical abstract
... Intravenous vernakalant has been approved by the European Medicine Agency [2010] for the rapid conversion of recent-onset AF [6]. To date, a number of studies have shown vernakalant to be well tolerated and effective for cardioversion of AF [7][8][9][10][11][12][13][14][15][16][17][18]. ...
... About 70% of patients were cardioverted within 12 min from onset of infusion and 11 h from the AF onset. Our findings confirm the safety and efficacy of vernakalant reported in previous studies [7][8][9][10][11][12][13][14][15][16][17][18][21][22][23][24][25] and extend their consistency to routine hospital use in large populations. To our knowledge, the present study provides the largest series of patients with recent-onset AF undergoing pharmacological cardioversion with a specific antiarrhythmic agent. ...
... Conversion to sinus rhythm with vernakalant was rapid (median time of 12.0 min) similar to what was previously reported [9][10][11][12][13][14][15][16][17][18]. The conversion median time of ibutilide was significantly longer than that of vernakalant (26 min versus 10 min, P = 0.01) in a randomized comparison [18]. ...
Article
Full-text available
Aims Rapid restoration of sinus rhythm using pharmacological cardioversion is commonly indicated in patients with symptomatic recent-onset atrial fibrillation (AF). The objectives of this large, international, multicenter observational study were to determine the safety and effectiveness of intravenous (IV) vernakalant for conversion of AF to sinus rhythm in daily practice. Methods and Results Consenting patients with symptomatic recent-onset AF (< 7 days) treated with IV vernakalant were enrolled and followed up to 24 h after the last infusion or until discharge, in order to determine the incidence of predefined serious adverse events (SAEs) and other observed SAEs and evaluate the conversion rate within the first 90 min. Overall, 2009 treatment episodes in 1778 patients were analyzed. The age of patients was 62.3 ± 13.0 years (mean ± standard deviation). Median AF duration before treatment was 11.1 h (IQR 5.4–27.0 h). A total of 28 SAEs occurred in 26 patients including 19 predefined SAEs, i.e., sinus arrest (n = 4, 0.2%), significant bradycardia (n = 11, 0.5%), significant hypotension (n = 2, 0.1%), and atrial flutter with 1:1 conduction (n = 2, 0.1%). There were no cases of sustained ventricular arrhythmias or deaths. All patients who experienced SAEs recovered fully (n = 25) or with sequelae (n = 1). Conversion rate to sinus rhythm was 70.2%, within a median of 12 min (IQR 8.0–28.0 min). Conclusions This large multicenter, international observational study confirms the good safety profile and the high effectiveness of vernakalant for the rapid cardioversion of recent-onset AF in daily hospital practice.