Biphasic versus monophasic cardioversion in shock-resistant atrial fibrillation:

Biphasic versus Monophasic Cardioversion. INTRODUCTION: Cardioversion of atrial fibrillation using monophasic transthoracic shocks occasionally is ineffective. Biphasic cardioversion requires less energy than monophasic cardioversion, but its efficacy in shock-resistant atrial fibrillation is unknown. Thus, we compared the efficacy of cardioversion using biphasic versus monophasic waveform shocks in patients with atrial fibrillation previously refractory to monophasic cardioversion. METHODS AND RESULTS: Fifty-six patients with prior failed monophasic cardioversion were randomized to either a 360-J monophasic damped sinusoidal shock or biphasic truncated exponential shocks at 150 J, followed by 200 J and then 360 J, if necessary. If either waveform failed, patients were crossed over to the other waveform. The primary endpoint was defined as the proportion of patients achieving sinus rhythm following initial randomized therapy. Stepwise multivariate logistic regression examined independent predictors of shock success, including patient age, sex, left atrial diameter, body mass index, drug therapy, and waveform. Twenty-eight patients were randomized to the biphasic shocks and 28 to the monophasic shocks. Sinus rhythm was restored in 61% of patients with biphasic versus 18% with monophasic shocks (P = 0.001). Seventy-eight percent success was achieved in patients who crossed over to the biphasic shock after failing monophasic cardioversion, whereas only 33% were successfully cardioverted with a monophasic shock after crossover from biphasic shock (P = 0.02). Overall, 69% of patients who received a biphasic shock at any point in the protocol were cardioverted successfully, compared to 21% with the monophasic shock (P < 0.0001). The type of shock was the strongest predictor of shock success (P = 0.0001) in multivariate logistic regression. CONCLUSION: An ascending sequence of 150-, 200-, and 360-J transthoracic biphasic cardioversion shocks are successful more often than a single 360-J monophasic shock. Thus, biphasic shocks should be the recommended configuration of choice for all cardioversions.     

A randomized trial comparing monophasic and biphasic waveform shocks for external cardioversion of atrial fibrillation

Background

We compared efficacy of and pain felt after biphasic truncated exponential (BTE) and monophasic damped sine (MDS) shocks in patients undergoing external cardioversion of atrial fibrillation (AF).

Methods

Patients with AF were randomized to BTE or MDS waveform cardioversion. Successive shocks were delivered at 70, 100, 200, and 360 J until successful cardioversion, with one 360 J attempt of the alternate waveform when all 4 shocks failed. Success was determined by blinded over-read of electrocardiograms. Peak current was calculated from energy and impedance. Patients rated their pain at 1 and 24 hours after cardioversion.

Results

Fourteen of 37 (38%) patients treated with MDS and 34 of 35 (97%) treated with BTE shocks were cardioverted at ≤200 J (P < .0001). Success rates of MDS versus BTE shocks were 5.4% versus 60% for 70 J, 19% versus 80% for ≤100 J, and 86% versus 97% for ≤360 J. BTE shocks cardioverted with less peak current (14.0 ± 4.3 vs 39.5 ± 11.2 A, P < .0001), less energy (97 ± 47 vs 278 ± 120 J, P < .0001), and less cumulative energy (146 ± 116 vs 546 ± 265 J, P < .0001). Patients felt less pain after BTE than MDS shocks at 1 hour (P < .0001) and 24 hours (P < .0001) after cardioversion.

Conclusion

This BTE waveform is superior to the MDS waveform for cardioversion of AF, requiring much less energy and current, and causing less postprocedural pain.     

Intravenous propafenone in paroxysmal atrial fibrillation: A randomized,placebo-controlled,double-blind,multicenter clinical trial

Background: Pharmacological conversion of paroxysmal atrial fibrillation is frequently necessary. The aim of this study was to compare intravenous propafenone, a class Ic antiar-rhythmic agent, with placebo in paroxysmal atrial fibrillation (AF) of recent onset (<72 h). Patients and methods: We randomly allocated 75 patients, aged 18 to 70 years, with paroxysmal AF to receive intravenous propafenone (2 mg/kg in 15 min followed by 1 mg/kg in 2 h) or the matching placebo. Patients were followed for 3 h. Exclusion criteria were the presence of one of the following: clinical heart failure, recent acute myocardial infarction, hypotension, atrioventricular block, Wolff-Parkinson-White syndrome, or current treatment with antiarrhythmic agents or digitalis. Results: No sign of heart disease was found in 74.7% of the patients. Echocardiographically determined left atrium diameter was similar in the two groups. Conversion to sinus rhythm occurred in 24 of 41 patients allocated to propafenone and in 10 of 34 patients allocated to placebo (odds ratio 3.2, 95% confidence intervals 1.3-7.9;p<0.01). Mean conversion time was 34 ± 29 and 71 ± 55 min, respectively, for propafenone and placebo. Mean heart rate in nonconverters decreased from 146 to 109 beats/min in patients treated with propafenone while it remained virtually unchanged in those treated with placebo. Only minor side effects were noted. Conclusions: Intravenous propafenone is an effective therapeutic option for restoring sinus rhythm in patients with paroxysmal AF of recent onset.     

Amiodarone versus propafenone for conversion of chronic atrial fibrillation: results of a randomized, controlled study

OBJECTIVES: The purpose of this study was to investigate the efficacy and safety of amiodarone and propafenone in the conversion of chronic atrial fibrillation in a prospective, randomized, placebo-controlled study. BACKGROUND: The effectiveness of amiodarone and propafenone in the treatment of patients with chronic atrial fibrillation has not been adequately studied. METHODS: One hundred one patients (48 men, mean age 64 +/- 9 years) with atrial fibrillation lasting >3 weeks participated in the study. Thirty-four patients received amiodarone (300 mg intravenously over 1 h, followed by 20 mg/kg over the next 24 h plus 600 mg orally, in three doses, for 1 week, then 400 mg/day orally, for three weeks), 32 received propafenone (2 mg/kg intravenously over 15 min, followed by 10 mg/kg over 24 h and then 450 mg/day orally, for one month) and the remaining 35 served as control subjects. All patients received digoxin and anticoagulant treatment as indicated (International Normalized Ratio 2 to 3). RESULTS: Conversion to sinus rhythm was achieved in 16 (47.05%) patients who received amiodarone, in 13 (40.62%) who received propafenone and in none of the control subjects (p < 0.001 for both groups vs. control subjects). Those who converted had smaller atria than those who did not and atrial fibrillation of shorter duration in both the amiodarone and propafenone groups. Treatment was discontinued in one patient of the propafenone group because of significant QRS widening. CONCLUSIONS: Amiodarone and propafenone appear to be safe and equally effective in the termination of chronic atrial fibrillation. Left atrial diameter and arrhythmia duration are independent predictors of conversion.     

Ambulatory electrocardioversion of atrial fibrillation by means of biphasic versus monophasic shock delivery. A prospective randomized study

Transthoracic electrical cardioversion using a monophasic waveform is the most common method converting persistent atrial fibrillation into sinus rhythm. Recently, cardioversion with a new biphasic waveform has shown promising results for treatment of atrial fibrillation. We undertook a randomized prospective trial comparing the efficacy and safety of the two waveforms for ambulatory cardioversion of atrial fibrillation. A total of 118 consecutive patients (mean age 62 years [SD 11]) presenting with persistent atrial fibrillation (mean duration 8 months [SD 11]) for ambulatory electrical cardioversion were randomized to receive either monophasic (n = 57) or biphasic shocks (n = 61). We used a standardized step-up protocol with increasing shock energies (100-360 joules) in either group. In all patients an anterior-posterior shock electrode position was used. If sinus rhythm was not achieved with the third (360 joules) shock, cardioversion was repeated with the opposite waveform. The two groups did not differ in demographic or disease-related data. The success rate was 100% for the biphasic and 73.7% for the monophasic waveform (p < 0.001). Biphasic patients required fewer shocks (1.5 versus 2.9) and a lower mean cumulative energy (203 versus 570 joules) (p < 0.001). Twelve out of 15 unsuccessfully treated monophasic patients were converted with biphasic shocks. The success rate for all 118 patients was 97.5%. No major acute complications were observed. For ambulatory transthoracic cardioversion of persistent atrial fibrillation biphasic shocks are of greater efficacy and require less energy than monophasic shocks. The procedure can be performed ambulatory and is safe regardless of shock waveform used.     

High-dose bolus lidocaine for chemical cardioversion of atrial fibrillation: a prospective, randomized, double-blind crossover trial

BACKGROUND: Most drugs used for chemical cardioversion of atrial fibrillation have significant proarrhythmia risk and require close monitoring after administration. Lidocaine has few of the proarrhythmic concerns of most antiarrhythmic drugs and, at high bolus doses, prolongs the atrial refractory period well enough to be effective in converting atrial fibrillation to sinus rhythm. This finding has been previously demonstrated in a dog model. We sought to confirm the animal findings in human beings with lidocaine doses of 1.5 to 2.5 mg/kg. METHODS: Twenty patients with atrial fibrillation scheduled for elective cardioversion were enrolled in this study. In a randomized, double-blind, crossover study design, each patient received intravenous bolus lidocaine or saline. Patients were observed for 10 minutes after the initial bolus to assess efficacy. The second test drug was then delivered if the first was unsuccessful at cardioversion. RESULTS: All 20 patients received both lidocaine and saline placebo therapy in a crossover manner. None of the 20 patients converted to sinus rhythm with either therapy. The 95% confidence interval for effectiveness of lidocaine in this population was 0% to 14%. CONCLUSION: In this population of patients referred for elective cardioversion of atrial fibrillation, high-dose bolus lidocaine was ineffective in converting patients to sinus rhythm. Although this study was not sufficiently powered to rule out a low efficacy of lidocaine (<15%) or a higher efficacy in certain subgroups of atrial fibrillation, routine use of lidocaine for this indication is not warranted.     

Prevention of chronic atrial fibrillation by pacing in the region of Bachmann's bundle: results of a multicenter randomized trial

INTRODUCTION: Atrial pacing locations that decrease atrial activation and recovery time may be preferable in patients with a history of atrial arrhythmias. This multicenter prospective randomized study compared the efficacy of Bachmann's bundle (BB) region pacing to right atrial appendage (RAA) pacing in patients with recurrent paroxysmal atrial fibrillation (AF). METHODS AND RESULTS: Patients with standard pacing indications (n = 120, 70+/-11 years) were randomized to atrial pacing in either the RAA (n = 57) or BB region (n = 63). Implantation time was similar between groups (88+/-36 min [n = 38] for BB vs 83+/-34 min [n = 34] for RAA). No differences in pacing threshold, impedance, or sensing between BB and RAA groups were observed at implantation or after the 6-week, 6-month, and 1-year follow-up periods. Average length of follow-up was 12.6+/-7.4 months for the BB group and 11.8+/-8.0 months for the RAA pacing group. The percentage of atrial pacing was similar between groups (61%+/-34% RAA vs 65%+/-31% BB at 2 weeks after implant). BB atrial pacing significantly (P < 0.05) shortened p wave duration compared with sinus rhythm (123+/-21 msec vs 132+/-21 msec, n = 50) 2 weeks after implant. In contrast, p wave duration was longer during atrial pacing from the RAA position compared with sinus rhythm (148+/-23 msec vs 123+/-23 msec, n = 37). Additionally, p wave duration was shorter during BB pacing than during RAA pacing. Patients with BB pacing had a higher (P < 0.05) rate of survival free from chronic AF (75%) compared with patients with RAA pacing (47%) at 1 year. CONCLUSION: BB region pacing is safe and effective for attenuating the progression of AF.     

Rate-control versus conversion strategy in postoperative atrial fibrillation: a prospective, randomized pilot study

BACKGROUND: Atrial fibrillation remains a frequent complication after heart surgery. The optimal strategy to treat the condition has not been established. Several retrospective studies have suggested that a primary rate-control strategy may be equivalent to a strategy that restores sinus rhythm. METHODS: Fifty patients with atrial fibrillation after heart surgery were randomly assigned to a strategy of antiarrhythmic therapy with or without electrical cardioversion or ventricular rate control. Both arms received anticoagulation with heparin overlapped with warfarin. The primary end point was time to conversion to sinus rhythm analyzed by the Kaplan-Meier method. Atrial fibrillation relapse after the initial conversion was monitored in the hospital over a 2-month period. RESULTS: There was no significant difference between an antiarrhythmic conversion strategy (n = 27) and a rate-control strategy (n = 23) in time to conversion to sinus rhythm (11.2 +/- 3. 2 vs 11.8 +/- 3.9 hours; P =.8). With the use of Cox multivariate analysis to control for the effects of age, sex, beta-blocker usage, and type of surgery, the antiarrhythmic strategy showed a trend toward reducing the time from treatment to restoration of sinus rhythm (P =.08). The length of hospital stay was reduced in the antiarrhythmic arm compared with the rate-control strategy (9.0 +/- 0.7 vs 13.2 +/- 2.0 days; P =.05). In-hospital relapse rates in the antiarrhythmic arm were 30% compared with 57% in the rate-control strategy (P =.24). There were no significant difference in relapse rates at 1 week (24% vs 28%), 4 weeks (6% vs 12%), and 6 to 8 weeks (4% vs 9%). At the end of the study, 91% of the patients in the rate-control arm were in sinus rhythm compared with 96% in the antiarrhythmic arm (P =.6). CONCLUSIONS: This pilot study shows little difference between a rate-control strategy and a strategy to restore sinus rhythm. Regardless of strategy, most patients will be in sinus rhythm after 2 months. A larger randomized, controlled study is needed to assess the impact of restoration of sinus rhythm on length of stay.     

External cardioversion of atrial fibrillation: comparison of biphasic vs monophasic waveform shocks.

AIMS: It is well established in transthoracic ventricular defibrillation that biphasic truncated waveform shocks are associated with superior defibrillation efficacy when compared with damped sine wave monophasic waveform shocks. The aim of this study was to explore whether biphasic waveform shocks were superior to monophasic waveform shocks for external cardioversion of atrial fibrillation (AF). METHODS AND RESULTS: Fifty-seven patients in whom cardioversion of AF was indicated were randomized in this prospective study, to transthoracic cardioversion with either monophasic damped sine waveform shocks or biphasic impedance compensating waveform shocks. In the group randomized to monophasic waveform shocks (27 patients), a first shock of 150 J was delivered, followed (if necessary) by a 360 J shock. In the biphasic waveform group (30 patients), the first shock had an energy of 150 J and (if necessary) a second 150 J was delivered. All shocks were delivered in the anterolateral chest pad position. Sinus rhythm was restored in 16 patients (51%) with the first monophasic shock and in 27 patients (86%) with the first biphasic shock. The difference was statistically significant (P=0.02). After the second shock, sinus rhythm was obtained in a total of 24 patients (88%) with monophasic shocks and in 28 patients (93%) with biphasic shocks. No complication was observed in either group and cardiac enzymes (CK, CKmb, troponin I, myoglobin) did not show any significant changes. CONCLUSION: This study suggests that at the same energy level of 150 J, biphasic impedance compensating waveform shocks are superior to monophasic damped sine waveform shocks cardioversion of atrial fibrillation.     

Comparison of the rectilinear biphasic waveform with the monophasic damped sine waveform for external cardioversion of atrial fibrillation and flutter

External cardioversion using the monophasic damped sine (MDS) waveform is successful 70% to 94% of the time when using up to 360 J. The rectilinear biphasic (RLB) defibrillator has been shown to be superior in efficacy to the MDS waveform in atrial cardioversion in a small randomized study. This larger, retrospective study compares the results of the RLB waveform with those of the MDS waveform for cardioversion of atrial fibrillation (AF) and atrial flutter in a large cohort of patients. We performed 1,877 external cardioversion procedures in 1,361 patients for AF and atrial flutter by using the RLB defibrillator. We compared these results with those of the MDS defibrillator in 2,025 patients who underwent 2,818 cardioversion procedures. The overall success rates for the RLB defibrillator were 99.1% for AF and 99.2% for atrial flutter, and the corresponding success rates for the MDS defibrillator were 92.4% and 99.8% (p <0.001; RLB superior for AF). The median overall successful energy level for the MDS waveform was 200 J, whereas the corresponding RLB energy level was 100 J. Multivariate analyses demonstrated that underlying clinical conditions or use of antiarrhythmic drugs does not significantly affect overall success rates. Our results from >4,000 procedures confirmed and extended those of the previous report by showing a very high success rate for cardioversion of AF and atrial flutter using the RLB waveform. The MDS waveform was equally effective for atrial flutter but significantly less effective in terminating AF.     

Budesonide treatment for collagenous colitis: a randomized,double-blind,placebo-controlled,multicenter trial

BACKGROUND & AIMS: Collagenous colitis is an idiopathic microscopic colitis characterized by chronic watery diarrhea, a typical subepithelial collagen layer, and lymphoplasmacellular infiltration. We investigated the effect of budesonide on symptoms and histology in patients with collagenous colitis in a randomized, double-blind, placebo-controlled multicenter trial. METHODS: Patients with chronic diarrhea and histologically proven collagenous colitis were randomized to receive either oral budesonide (Entocort capsules; AstraZeneca, Sodertalje, Sweden) 9 mg/day for 6 weeks or placebo. Complete colonoscopy was performed before and after treatment. Histopathology was assessed by a single pathologist blinded to the patients' treatment. Clinical symptoms were assessed by standardized questionnaires. RESULTS: Fifty-one patients were randomized; 45 patients were available for per protocol analysis. The rate of clinical remission was significantly higher (P < 0.001) in the budesonide group than in the placebo group (per protocol 86.9% vs. 13.6%, respectively; intention-to-treat 76.9% vs. 12.0%, respectively). Histologic improvement was observed in 14 patients of the budesonide group (60.9%) and in 1 patient of the placebo group (4.5%; P < 0.001). Two patients in the budesonide group (7.7%) and 1 patient in the placebo group (4.0%) discontinued treatment prematurely because of side effects. CONCLUSIONS: Oral budesonide (Entocort capsules) is an effective and safe treatment modality for patients with collagenous colitis. Long-term follow-up of these patients is necessary to investigate whether clinical and histologic remission is sustained.     

Zafirlukast treatment for acute asthma: evaluation in a randomized, double-blind, multicenter trial

CONTEXT: Acute asthma causes nearly 2 million hospital emergency department (ED) visits in the United States annually, and hospitalization after an ED visit and relapse after ED discharge are common. OBJECTIVE: To evaluate the adding of therapy with zafirlukast to standardized care for patients with acute asthma in the ED and a 28-day follow-up period. DESIGN AND PATIENTS: A total of 641 patients presenting to the ED with acute asthma were randomized to receive either single-dose zafirlukast, 160 mg (Z160) [162 patients], zafirlukast, 20 mg (Z20) [158 patients]), or placebo (321 patients) as adjunct treatment to standard care in this double-blind, multicenter trial. Assessments, including spirometry and symptom scores, were obtained before each albuterol treatment and at 4 h. Patients who were discharged from the ED after 4 h continued outpatient therapy over a 28-day period and received either Z20 bid (276 patients) or placebo (270 patients) in addition to prednisone, albuterol, and their previous asthma medications. FEV(1) was measured at clinic visits on days 10 and 28. Patients recorded outpatient clinical data twice daily on a home diary card. MAIN OUTCOME MEASURES: the effect of zafirlukast on relapse after ED discharge. Other assessments were the rate of extended care (ie, ED stay for > 4 h or hospitalization), FEV(1), and symptoms. RESULTS: At the end of the outpatient period, 65 of 276 patients (23.6%) treated with zafirlukast and 78 of 270 patients (28.9%) treated with placebo relapsed (p = 0.047; absolute reduction, 5.3%; relative reduction, 18.3%). At the end of the ED period, 16 of 162 patients (9.9%) treated with Z160, 26 of 158 patients (16.5%) treated with Z20, and 48 of 321 patients (15.0%) treated with placebo required extended care (p = 0.052; absolute reduction with Z160 compared to placebo, 5.1%; relative reduction, 34%). These findings were supported by a significant improvement in FEV(1) and dyspnea in the ED with the use of Z160 therapy, and by greater improvement in FEV(1) and symptoms during the outpatient period for patients treated with Z20. CONCLUSIONS: When added to standardized care, therapy with Z20 bid reduced the risk of relapse compared with placebo over a 28-day treatment period. One dose of Z160 in the ED also reduced the rate of extended care.