In recent years it has been shown that catheter ablation of symptomatic atrial fibrillation (PAF) is superior to antiarrhythmic drug therapy with regards to effectiveness and clinical outcomes. Atrial fibrillation is the most common cardiac arrhythmia, with high rates of concomitant heart failure, stroke and mortality. During an ablation procedure, a patient can be managed with intravenous sedation or General Anesthesia (GA). Within this setting, General anesthesia is associated with improved procedure time and cure rate compared to sedation. Airway management during GA can be achieved through a laryngeal mask airway (LMA) or an endotracheal tube (ETT). The use of LMA compared to ETT has been shown in different surgical populations to decrease procedure and recovery time, improve hemodynamic stability and reduce anesthetic requirements. It has also shown to decrease airway complications, and postoperative nausea/vomiting which are important factors that affect overall patient satisfaction. Although general anesthesia in electrophysiology procedures is associated with a higher cure rate, there have been reports of increased airway trauma.Additionally, it is believed that volatile anesthetics may be associated with increased ventricular action potential duration as well as prolonged QT interval. The increased usage of opioids during general anesthesia is also thought to interfere with electrophysiology studies by affecting vagal tone. At Virginia Commonwealth University (VCU) Health system, Anesthesiologists have been successfully using LMA (General Anesthesia) for ablation in PAF in eligible patients for over five years. The investigators plan to perform a retrospective review of all patients who underwent catheter ablation of PAF at Virginia Commonwealth University Health System from January 2014 - December 2015. The primary endpoint evaluated will be procedure time. Other data collected will include demographics, cardiac history, type of anesthesia, amount of intra-procedure opioids, time to discharge from post anesthesia care unit (PACU), total length of hospital stay, intra-procedure hemodynamics, intra-procedure ionotrope/chronotrope/pressor requirements. and atrial fibrillation recurrence at a 3 month follow-up.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE
Enrollment
100
Patient randomized to this arm will have general anesthesia with endotracheal tube placed and will be kept at an appropriate depth of anesthesia for patient comfort and procedure needs.
Patients randomized to this arm will have general anesthesia with laryngeal mask airway placed and will be kept at an appropriate depth of anesthesia for patient comfort and procedure needs.
Virginia Commonwealth University
Richmond, Virginia, United States
Procedure Time (Minutes)
Will be measured as time from start of procedure to end of procedure, as recorded in minutes
Time frame: Up to 270 minutes
Fluoroscopy Time
As measured and reported by electrophysiology and radiology notes, recorded in minutes
Time frame: Up to 270 minutes
Total Anesthesia Time
Total anesthesia time as measured in minutes and recorded in the anesthesia record, from anesthesia start time to anesthesia stop time
Time frame: Up to 270 minutes
Time to Discharge From PACU
time from arrival to PACU until discharge from anesthesia care
Time frame: Up to 7 days
Total Intra-procedure Opioids
Measured in mcg of Fentanyl
Time frame: Up to 270 minutes
Anesthetic Requirements
average end tidal volatile anesthetics Measured as intra operative anesthetic (MAC)
Time frame: Up to 270 minutes
Anesthetic Requirements
average amount of intravenous anesthetics
Time frame: Up to 270 minutes
Intraoperative Hemodynamics
heart rate (beats per minute)
Time frame: Up to 270 minutes
Intraoperative Hemodynamics
mean arterial pressure
Time frame: Up to 270 minutes
Intraoperative Hemodynamics
systolic blood pressure
Time frame: Up to 270 minutes
Intraoperative Hemodynamics
diastolic blood pressure
Time frame: Up to 270 minutes
Intraprocedure Pressor/Ionotrope/Chronotrope Requirements
total measured amounts of all pressors/ionotropes and chronotropes administered intraoperatively
Time frame: Up to 270 minutes
Electrophysiology Parameters
duration of paroxysmal atrial fibrillation prior to procedure
Time frame: Up to 270 minutes
Electrophysiology Parameters
size of left atrium (mm)
Time frame: Up to 270 minutes
Electrophysiology Parameters
left ventricular ejection fraction
Time frame: Up to 270 minutes
Airway Trauma
Any noted trauma in the anesthesia or post-procedure notes, including damage to lips/teeth, laryngospasm, need for reintubation post procedure
Time frame: Up to 7 days
Post-procedure Nausea
Measured by number of doses of antiemetics given in the post-procedure time period mg of Zofran (ondanesteron) given post-operatively
Time frame: Up to 7 days
Post-procedure Emesis
Measured by number of times patient has emesis during post-procedure time period
Time frame: Up to 7 days
Atrial Fibrillation Recurrence
defined as recurrence of paroxysmal atrial fibrillation recurring at any time after 6 weeks past the day of procedure. As standard of care these patients are followed up with Holter monitoring for a period of 6 months. Holter monitoring will be done for 48 hour time periods immediately post-procedure, 2 weeks, 6 weeks, 4 months and 6 months post procedure as is standard of care
Time frame: From end of procedure to six month followup holter monitor
Aspiration Events
aspiration events as noted in the anesthesia, PACU and post procedure notes would be documented
Time frame: Up to 7 days
Patient Satisfaction
patients will be given an survey by study personnel prior to discharge from the hospital; survey will be conducted in person by study personnel
Time frame: Up to six months
Cost Analysis
an analysis of cost to patient as well as overall hospital costs will be conducted
Time frame: Up to six months
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