Esophageal Cooling Proves Helpful For Injury Prevention During Cardiac Ablation
Overview
In this study, proactive esophageal cooling, cleared by the FDA to reduce the risk of esophageal injury during radiofrequency cardiac ablation procedures, was investigated for its impact on procedure efficiency. The research aimed to assess the change in electrophysiology (EP) lab throughput for pulmonary vein isolation (PVI) cases following the adoption of proactive esophageal cooling.
Data from three EP groups were analyzed, comparing throughput before and after the adoption of proactive cooling. A total of 2498 PVIs were performed over 74 months across the sites, with proactive cooling introduced at different times. Before adoption, PVIs utilized luminal esophageal temperature (LET) monitoring, with proactive cooling added as needed. Post-adoption, proactive cooling was exclusively employed.
Results showed a notable increase in throughput post-adoption, with 1472 PVIs performed using proactive cooling, representing a mean 43% increase in throughput (p < .0001). This increase was observed despite the loss of two operators during the post-adoption period.
In conclusion, the study highlights that the adoption of proactive esophageal cooling during PVI ablation procedures significantly enhances EP lab throughput. This finding holds true even after adjustments for changes in the number of operating physicians. These results underscore the potential benefits of proactive cooling in enhancing procedural efficiency and patient care during RF cardiac ablation procedures.
Introduction
Atrial fibrillation (AF) stands as the most prevalent form of arrhythmia in the United States, with its incidence on the rise, particularly as the population ages. Pulmonary vein isolation (PVI), a procedure increasingly in demand for treating AF, has led to longer waiting lists for patients. To address this issue, strategies to enhance the efficiency of electrophysiology (EP) labs are crucial.
Recently, a specialized device designed for proactive esophageal cooling gained clearance from the US Food and Drug Administration (FDA) to mitigate the risk of esophageal injury during radiofrequency (RF) cardiac ablation procedures. Its adoption has yielded notable benefits beyond mere injury reduction, including shortened procedural durations, enhanced long-term outcomes, and diminished fluoroscopy requirements compared to procedures relying solely on luminal esophageal temperature (LET) monitoring.
The reduced duration of procedures not only enhances patient safety by minimizing anesthesia exposure but also potentially allows for more procedures to be completed within a given timeframe. Despite these advantages, the impact of proactive esophageal cooling on EP lab throughput remains unexplored.
This study seeks to quantify the effect of introducing proactive esophageal cooling, facilitated by a dedicated cooling device, on EP lab throughput across three distinct EP groups conducting PVI cases. By examining this influence, the study aims to provide valuable insights into optimizing procedural efficiency and resource utilization within EP labs.
Method
This study, conducted as a subset of a larger retrospective analysis of prospectively collected data, focused on patients undergoing left atrial ablation for atrial fibrillation (AF) treatment via pulmonary vein isolation (PVI). The research compared outcomes before and after the adoption of proactive esophageal cooling during these procedures.
Data from three electrophysiology (EP) labs within hospital systems were gathered over equal periods before and after the implementation of proactive esophageal cooling. In the pre-adoption phase, monitoring of esophageal temperature (with esophageal deviation as needed) was utilized for esophageal protection. In contrast, proactive esophageal cooling (using ensoETM®; Attune Medical) replaced temperature monitoring or deviation in the post-adoption period, implemented at each site at different times.
The study divided the analysis into two equivalent time frames: pre-adoption and post-adoption of proactive esophageal cooling. Despite the loss of two operators in the post-adoption phase, the study design facilitated the comparison of procedural volumes between the two periods while maintaining consistency in location and patient demographics.
Data analysis involved comparing the total number of procedures completed in each equivalent time frame to ascertain the difference in procedural volumes with and without proactive cooling. Statistical significance was determined by assessing the increase in rate, assuming a Poisson distribution with equal rate parameters before and after cooling adoption. The analysis employed a two-sided exact test with a significance level of 0.05 and provided a 95% confidence interval for the rate ratio, executed using the poisson.test function in R.
Overall, the study aimed to evaluate the impact of proactive esophageal cooling on procedural volumes and outcomes during left atrial ablation for AF treatment, utilizing robust statistical methods to draw conclusions.
Result
The study encompassed 2498 patients undergoing Pulmonary Vein Isolation (PVI) ablations across three medical facilities over a span of 74 months. Notably, no additional operators were incorporated post-adoption, and there were no expansions in lab space. However, two sites experienced the departure of one operator each during the post-adoption phase. The number of operating days remained consistent before and after adoption at each site.
Procedural methodologies for left atrial PVI ablations were aligned with standard practices in the United States. General anesthesia was administered to all patients. Various techniques such as Wide area circumferential PVI, additional posterior wall isolation, mitral isthmus lines, and cavotricuspid isthmus lines were employed based on patient requirements or physician preference. Operators utilized irrigated contact force sensing catheters and maintained power settings within the range of 40−50 W. A Visitag Surpoint® ablation index was targeted during procedures. Noteworthy changes included the adoption of proactive esophageal cooling and the discontinuation of LET monitoring and esophageal deviation.
Pre-adoption measures involved LET monitoring or esophageal deviation for esophageal protection. In contrast, post-adoption procedures utilized proactive cooling with ensoETM®. This device, approved by the FDA in September 2023, circulated distilled water at a controlled temperature of 4°C within the esophagus, eliminating the need for temperature monitoring during ablation.
Throughput data revealed a significant increase in procedures post-adoption across all sites. Site 1 saw a rate ratio increase of 1.50, site 2 increased by 1.2, and site 3 witnessed a rate ratio increase of 2.21. Overall, there was a 43% increase in EP lab throughput across the three hospitals post-adoption, despite the loss of one operator each in two sites. Procedure time reductions ranged from 10% to 40% across sites.
In conclusion, transitioning to proactive esophageal cooling was associated with enhanced EP lab throughput and procedural efficiency across multiple medical facilities, demonstrating the effectiveness of this approach in improving patient care outcomes.
Conclusion
The recent FDA clearance of proactive esophageal cooling for reducing the risk of ablation-related esophageal injury during RF cardiac PVI ablation procedures marks a significant advancement. A comprehensive review involving over 25,000 patients demonstrated notable reductions in atrioesophageal fistula formation with proactive esophageal cooling.
In the initial analysis of the impact of proactive esophageal cooling on EP lab throughput, a substantial 43.5% increase was observed compared to procedures utilizing LET monitoring and esophageal deviation, despite the loss of one operator in two of the three sites analyzed. This heightened efficiency was primarily attributed to the decreased procedural duration facilitated by proactive esophageal cooling.
Studies revealed substantial reductions in procedure times with proactive esophageal cooling compared to LET monitoring, owing to the elimination of interruptions caused by local overheating conditions. This uninterrupted lesion progression not only streamlines procedures but also enhances patient outcomes by potentially reducing wait times, which are crucial in mitigating the risk of persistent atrial fibrillation associated with delays in care.
Although the retrospective nature of the data presents inherent limitations, the consistency of findings across multiple hospital sites and the absence of significant demographic differences between groups suggest a robust association between proactive esophageal cooling adoption and increased EP lab throughput. Despite fluctuations in procedural volumes due to external factors like COVID-19 regulations, the observed improvements remained consistent.
While operator experience may influence procedural efficiency, the majority of physicians involved in the analysis were experienced or senior operators, minimizing the impact of this factor on the reported outcomes.
In conclusion, the adoption of proactive esophageal cooling during PVI ablation procedures shows a substantial enhancement in EP lab throughput, even in scenarios where the total number of operating physicians is reduced post-adoption. This advancement not only streamlines procedural workflow but also holds promise for improving patient outcomes and reducing the burden of atrial fibrillation.
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