A Comparison of Biphasic Truncated Exponential and Pulsed Waveforms for Cardioversion of Atrial Fibrillation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 75
- Locations
- 2
- Primary Endpoint
- Defibrillator Efficacy - The cumulative delivered energy
Study Overview
Brief Summary
Background: Biphasic truncated exponential (BTE) waveforms are standard for cardiac defibrillation and synchronized cardioversion up to date. BTE waveforms differ by design characteristics and technologies for pulse commutation (rectilinear, standard truncated exponential, pulsed). Clinical evaluation of BTE waveforms can be planned during cardioversion (CVS) as a well-established procedure of atrial fibrillation patients who are able to give consent and also present a more controlled population.
Scarce studies have been found to present the relative efficacy and safety of different BTE waveforms during CVS. The validity of significantly deviating results of the pulsed waveform in one CVS study is questionable.
Objective: To compare the CVS efficacy and safety two different biphasic defibrillators - a standard truncated exponential waveform and a pulsed biphasic waveform.
Experimental design: Patients will be recruited at the Intensive Cardiology Care Unit (ICCU), Cardiology Clinic, University National Heart Hospital (NHH), Sofia, Bulgaria, underwent the pre-CVS medical exams and check for eligibility. All eligible patients will sign a written informed consent prior to the CVS and will receive the standard hospital procedures during CVS, accepted in the NHH, and approved by the NHH Local Ethic Committee.
Atrial fibrillation patients will be alternatively randomized to CVS using one of the two defibrillators, following the same energy selection protocol in both defibrillators. The statistical power analysis will consider a non-inferiority comparison between the cumulative energy actually delivered by both defibrillators.
The secondary CVS outcome measures are: the cumulative success rate (measured at 1 minute post-shock) and number of delivered shocks. Delivered energy will be measured during each shock with a dedicated pulse recording device (approved by the NHH Local Ethic Committee). Heart rhythm will be monitoring in continuously recorded peripheral ECG.
The secondary CVS safety outcome measures: Biochemical markers for myocardial necrosis (high sensitive troponin I - hsTnI, creatine kinase MB fraction - CK-MB) will be evaluated on blood samples taken before and 12 hours after cardioversion; ST-segment changes will be measured in lead II (baseline and 10 s post-shock) and 12-lead ECG; Complications after cardioversion will be measured during 2 hours follow-up period in the ICCU.
Detailed Description
Background:
External defibrillators are routinely used for treatment of lethal ventricular arrhythmias (defibrillation) as well as atrial and non-lethal ventricular arrhythmias (synchronized CVS). Commercially available defibrillators generate direct current (DC) shock with various waveforms using distinct technologies. These waveforms are suggested to have different efficacy and safety, aiming at a positive effect with lower cumulative energy, smaller number of shocks, and less post-shock complications and myocardial injury. Therefore, the efficacy and safety of different waveforms has been an object of continuous interest and clinical investigations over the last years. Although the superiority of biphasic over monophasic waveforms is well established, the relative efficacy and safety of the available biphasic waveforms is not clear.
Most defibrillator manufacturers use the biphasic truncated exponential (BTE) waveform. Almost all BTE defibrillators are embedding the impedance compensation technology, which adapts the pulse duration for proper delivery of the selected energy. However, various pulse commutation concepts produce differently shaped waveforms:
- rectilinear (impedance compensation with constant pulse duration);
- standard truncated exponential (impedance compensation with constant tilt);
- pulsed (impedance compensation with constant duty cycle and constant tilt). Clinical studies with patients presenting with shockable life-threatening arrhythmias are difficult to perform for ethical and practical reasons. Several studies have therefore included patients requiring elective CVS for atrial arrhythmias, who are able to give consent and also present a more controlled population. Elective CVS is a standard treatment for patients with atrial arrhythmias and is performed as a day case procedure under general anesthesia. The investigator's bibliographic research found 6 studies from which the dose-response curves of 4 rectilinear, 7 standard truncated exponential and 3 pulsed waveforms have been drawn. Although the major disparities between the studies (success accounted at different delays after CVS, rhythm inhomogeneity, different population sizes, different selected energy levels, etc.) the dose-response curves concentrate within 85-95% success rate and 300-500 joules (J) cumulative energy. More data on the efficacy of the pulsed waveform during CVS are needed.
Various BTE waveforms apply different potential gradients on the thorax that might produce various defibrillation effects. Apart from efficacy, the most important aspect is the patient safety, considering that larger potential gradients in the myocardium lasting longer could potentially induce an electroporation and then a fibrillation. A frequently observed effect of electroporation are the post-shock ST-segment deviations in the surface ECG, representing the potential difference between the normal tissue and sustained depolarized critical mass of myocardium closest to the associated origin of the electrical current. Although ST-segment changes are an easily ignored phenomenon, occurring acutely and resolving during the first few minutes post-shock, their presence in a short-term basis can identify electroporation by dangerously high potential gradients, while the sustained ST-changes in a long-term basis can identify cases with myocardial injury. The most reliable quantification of shock-induced myocardial injuries is based on measurements of the hsTnI biomarker after CVS. The safety of shocks contemplates any other complications after CVS, such as apnea, arrhythmias, etc. The variety of safety outcomes for different BTE waveforms is not clear.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •(indications for elective cardioversion of atrial fibrillation):
- •Patients > 18 years old and:
- •Symptomatic AFIB with a duration of less than 12 months - EHRA score 2-4
- •Symptomatic first detected AFIB - EHRA score 2-4
- •Persistent AFIB after successful causal therapy
Exclusion Criteria
- •The patients are excluded if one of these conditions is present:
- •Patients with atrial flutter
- •Spontaneous HR <60/min
- •Digitalis intoxication
- •Impossibility to maintain sinus rhythm irrespective to antiarrhythmic therapy and frequent cardioversions
- •Conduction disturbances (without fascicular block and AV block 1 degree) in patients without pacemaker
- •Asymptomatic patients with AFIB for > 1 year
- •Thyroid dysfunction: euthyroid status of at least one month is required (TSH is measured).
- •Thrombosis in cardiac cavities, assessment performed using Transesophageal echocardiography (TEE)
- •Spontaneous echo contrast > 2 degree (TEE)
- •Patients with planned cardiac operation in the next three months
- •Patients with embolic event in the last three months
- •Patients <18 years of age
- •Pregnancy
Outcomes
Primary Outcomes
Defibrillator Efficacy - The cumulative delivered energy
Time Frame: At the end of CVS. Delivered energy (Joules) will be measured during each shock with a dedicated pulse recording device
The cumulative delivered energy by consecutive defibrillation shocks during cardioversion. The cumulative delivered energy is the sum of energies delivered by the consecutive shocks, showing the total energy delivered to the body during cardioversion. It is proportional to the total dissipated heat in the heart that is assumed as the major factor for myocardial injury. The cumulative delivered energies of the two defibrillators will be compared.
Secondary Outcomes
- Defibrillator Safety - Changes in the concentration of biochemical markers(12 hours after CVS +/- 4 hours. The blood samples will be taken before cardioversion (on the same day) and after cardioversion (from 8 to 12 hours after the intervention))
- Defibrillator Safety - Complications after cardioversion(2 hours after CVS. ECG and close patient attendance will be applied during 2 hours follow-up period in Intensive Cardiology Care Unit)
- Defibrillator Efficacy - The cumulative success rate(At the end of CVS. Peripheral ECG will be continuously recorded during cardioversion and the presence of sinus rhythm will be read by a cardiologist at the first minute after each shock)
- Defibrillator Efficacy - Number of shocks(At the end of CVS. During the whole cardioversion procedure, each electrical shock delivered to the patient will be counted)
- Defibrillator Safety - ST-segment changes(At the end of CVS. ST-segment will be measured by a cardiologist in the continuously recorded lead II (immediately before cardioversion and 10s after each shock (80 ms after J point in the first QRS at 10 s post-shock); as well as in standard 12 lead ECG)
- Defibrillator Safety - the rate of patients with elevated biochemical markers(12 hours after CVS +/- 4 hours)
Investigators
Elina Trendafilova
Prof.
University National Heart Hospital
