Patients
This was a retrospective data review performed with Institutional Review Board approval from the two healthcare systems involved, the NorthShore University HealthSystem and the Texas Cardiac Arrhythmia Research Foundation at St. David’s South Austin Medical Center. A consent form was not required because this was secondary research that used identifiable private information recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained directly or through identifiers linked to the subjects. All patients who underwent PVI performed by any of four electrophysiologists in two healthcare systems encompassing 3 different hospitals over the study timeframe from January 2018 to March 2020 were included in this analysis. No patients who underwent PVI were excluded from this review. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) guidelines for reporting observational studies were followed.
Ablation Procedure
The general procedures utilized by operators at the study sites have been previously described.[10, 11] All patients were treated under general anesthesia for their ablation procedure. Electrophysiologist physicians at all sites performed primarily wide area circumferential pulmonary vein isolation with additional posterior wall isolation dependent on physician practice. In all cases, anticoagulation was administered prior to ablation with a heparinized target activated clotting time (ACT) of 300 to 350 seconds. All sites utilized the Carto system (Biosense Webster, Inc., Diamond Bar, CA, USA) to obtain electroanatomical maps and create a three-dimensional geometry using a mapping catheter (PentaRay or Lasso; Biosense Webster, Inc.). An ICE catheter (AccuNav; Siemens, Mountain View, CA, USA or Soundstar, Biosense Webster, Inc., Diamond Bar, CA, USA) was positioned in the right atrium to guide the transseptal puncture, and for ablation, an externally irrigated ablation catheter (ST/SF™; Biosense Webster, Inc.) was used in all cases, and a steerable decapolar catheter (Webster CS Catheter; Biosense Webster, Inc., Diamond Bar, CA, USA) was placed into the coronary sinus for pacing and recording. A very low to no fluoroscopy protocol was followed for all procedures.
In one healthcare system, the pulmonary veins were isolated by delivery of RF applications circumferentially to the antral regions to produce a minimum of entrance and exit block for at least 20 minutes, confirmed during isoproterenol infusion at 10 μg/min. A Smartablate™ generator (Biosense Webster, Inc.) was used to deliver RF energy, with a setpoint of 40 W on all patients and all areas of the left atrium. The Surepoint measure (Biosense Webster, Inc.) was utilized during ablations, with a target of 350 units on the posterior wall and 450 units on the anterior wall, lateral wall, and septum.
In the other healthcare system, the posterior wall was isolated using a combination of roof and floor linear lesions, along with additional lesions to further segment the posterior wall to achieve entrance and exit block (using output of 20 mA and 5 ms pulses). The pulmonary veins were isolated by delivery of RF applications circumferentially to the antral regions. Entrance and exit block was confirmed for up to 20 min. A Smartablate™ generator (Biosense Webster, Inc., Diamond Bar, CA, USA) was used to deliver RF energy, with a setpoint of 50 W on all patients and all areas of the left atrium. The Visitag Surpoint module (ablation index) was utilized during ablations, with a target of 400 units on the posterior wall, and 550 units on the anterior wall, lateral wall, and septum and an intertag distance of less than 6 mm. Patients with paroxysmal AF received only pulmonary vein isolation without additional posterior wall ablation, whereas patients with persistent AF received additional posterior wall isolation, in which lines were placed with homogenization until exit block was demonstrated throughout at highest output.
Esophageal Protection
Prior to adoption of active esophageal cooling, standard LET monitoring was utilized in all cases. In one hospital system, the majority of sensors used were single-sensor probes, with approximately 10% of them receiving a multi-sensor probe (Circa S-Cath; Circa Scientific, Inc., Englewood, CO, USA). Energy delivery was discontinued when the maximum LET on the single-sensor temperature probe or on any sensor of the multi-sensor probe rose by more than 0.2°C/s, or exceeded 39°C. In patients treated with active cooling, the position of lesions on the posterior wall was adjusted if needed to avoid ablation directly over the esophagus if the tissue thickness (atrium and esophageal wall) was less than approximately 2 mm as viewed on ICE. Otherwise, the ablation proceeded in a point-to-point fashion uninterrupted by pauses or alarms. In the other healthcare system, LET monitoring was predominantly via a multi-sensor probe (Circa S-Cath, Circa Scientific, Inc., Englewood, CO, USA). RF ablation was stopped and the site of ablation moved to a different distant area of the veins for any alarm over 0.2 °C/s, or a temperature exceeding 38.5 °C.
After the adoption of active esophageal cooling in both healthcare systems, no temperature probe was utilized with the esophageal cooling device. Ablation proceeded in a point-to-point fashion uninterrupted by pauses due to temperature elevations or overheating alarms. Active esophageal cooling was performed using the ensoETM device (Attune Medical, Chicago, IL, USA), a closed-loop silicone tube that is inserted into the esophagus in similar fashion to a standard orogastric tube (Figure 1.). The device is connected to a temperature controlled heat-exchanger which circulates 4 °C water at 2.4 L/min. Placement is confirmed via either fluoroscopy or with ICE. Except for the change to the esophageal cooling protocol, the ablation procedure for patients in each hospital remained the same.
Definitions
Atrial arrhythmia included AF, atrial flutter, and atrial tachycardia (AT). Paroxysmal AF (PAF) was considered to be episodes of AF that terminate spontaneously. Patients with persistent AF had episodes that continued for >7 days and were not self-terminating. Patients with long-standing persistent AF had ongoing long-term episodes of AF for over a year.
Determination of rhythm status
Rhythm status was determined by review of the electronic medical record or existing practice records maintained by the physician practice group. This review focused specifically on status at the 12-month follow-up visit, or the last visit attended by the patient earlier than the 12-month follow-up visit in cases in which a visit was not completed within two months of the 12-month anniversary of the index PVI procedure. In the vast majority of cases, visits were in-person, with only a small number of visits occurring via virtual or telehealth visit. Rhythm status was determined by ECG, Holter monitor, wearable patch monitor, pacemaker/defibrillator, or implantable loop recorder. Wearable patch monitoring was typically performed with commercially available devices such as Zio patch (iRhythm Technologies, San Francisco, CA) or CAM patch (Bardy Diagnostics, Bellevue, WA). Patient self-monitoring using personal devices, such as AliveCor Kardia, Fitbit, Apple Watch, etc.) also generally increased during this study period, providing another means by which patients might identify a recurrence of arrhythmia and present to the hospital.
Statistical analysis
Continuous variables are expressed as mean +/- standard deviation, with categorical variables reported in percentile value. Kaplan-Meier curves were created and analyzed using the log-rank test to compare the rate of freedom from arrhythmia between patients receiving LET monitoring and patients receiving active esophageal cooling. Assumptions for Kaplan-Meier analysis were (1) the event status consists of two mutually exclusive and collectively exhaustive states (sinus or arrhythmia), (2) the time to an event or censorship is clearly defined, (3) left-censoring should be minimized or avoided, (4) independence exists between censoring and the event, and (5) a similar amount and pattern of censorship exists in each group. The assumption of no secular trends in the data was violated by the increased use of wearable monitors over time and the greater age and comorbidities of patients undergoing ablations; however, both trends bias towards the null. Results were considered significant with a p value <0.05. Statistical analyses were performed using IBM SPSS Statistics software, version 26 (IBM, Armonk, New York).