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\begin{document}

\title{Association Between Proactive Esophageal Cooling and Increased Lab
Throughput}



\author[1]{William Zagrodzky}%
\author[2]{Julie Cooper}%
\author[2]{Christopher Joseph}%
\author[3]{Matthew Sackett}%
\author[3]{Jose Silva}%
\author[3]{Richard Kuk}%
\author[3]{Julia McHugh}%
\author[4]{Babette Brumback}%
\author[5]{Shirley Park}%
\author[5]{Robert Hayward}%
\author[5]{Taresh Taneja}%
\author[5]{Andrew Vu}%
\author[5]{Taylor Liu}%
\author[2]{Erik Kulstad}%
\author[6]{Andrew Kaplan}%
\author[7]{Archana Ramireddy}%
\author[8]{Samuel Omotoye}%
\affil[1]{Colorado College}%
\affil[2]{The University of Texas Southwestern Medical Center}%
\affil[3]{Centra Health}%
\affil[4]{University of Florida Department of Biostatistics}%
\affil[5]{Kaiser Permanente Santa Clara Medical Center}%
\affil[6]{Banner Heart Hospital}%
\affil[7]{Cedars-Sinai Medical Center Palliative Care Services}%
\affil[8]{Cleveland Clinic}%


\vspace{-1em}



  
  \date{June 18, 2024}


\begingroup
\let\center\flushleft
\let\endcenter\endflushleft
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\selectlanguage{english}
\begin{abstract}
\textbf{Introduction}: Proactive esophageal cooling has been FDA cleared
to reduce the likelihood of ablation-related esophageal injury resulting
from radiofrequency (RF) cardiac ablation procedures. Data suggest that
procedure times for RF pulmonary vein isolation (PVI) also decrease when
proactive esophageal cooling is employed instead of luminal esophageal
temperature (LET) monitoring. Reduced procedure times may allow
increased electrophysiology (EP) lab throughput. We aimed to quantify
the change in EP lab throughput of PVI cases after the introduction of
proactive esophageal cooling. \textbf{Methods}: EP lab throughput data
were obtained from three electrophysiology groups. We then compared EP
lab throughput over equal time frames at each site before (pre-adoption)
and after (post-adoption) the adoption of proactive esophageal cooling.
\textbf{Results}: Over the time frame of the study, a total of 2,498
PVIs were performed over a combined 74 months, with cooling adopted in
September 2021, November 2021 and March 2022 at each respective site. In
the pre-adoption time frame, 1,026 PVIs were performed using a
combination of LET monitoring with the addition of esophageal deviation
when deemed necessary by the operator. In the post-adoption time frame,
1,472 PVIs were performed using exclusively proactive esophageal
cooling, representing a mean 43\% increase in throughput (p \textless{}
0.0001), despite the loss of two operators during the post-adoption time
frame. \textbf{Conclusion}: Adoption of proactive esophageal cooling
during PVI ablation procedures is associated with a significant increase
in EP lab throughput, even after a reduction in total number of
operating physicians in the post-adoption group.%
\end{abstract}%



\sloppy


\textbf{Association Between Proactive Esophageal Cooling and Increased
Lab Throughput}

William Zagrodzky, BA\textsuperscript{1}, Julie Cooper,
MD\textsuperscript{2}; Christopher Joseph, MD\textsuperscript{2};
Matthew Sackett, MD\textsuperscript{3}; Jose Silva,
MD\textsuperscript{3}; Richard Kuk, MD\textsuperscript{3}; Julia McHugh,
MD, PhD\textsuperscript{3}; Babette Brumback, PhD\textsuperscript{4};
Shirley Park, MD\textsuperscript{5}; Robert Hayward,
MD\textsuperscript{5}; Taresh Taneja, MD\textsuperscript{5}; Andrew Vu,
MD\textsuperscript{5}, Taylor Liu, MD, PhD\textsuperscript{5}; Erik
Kulstad, MD, MS\textsuperscript{2}; Andrew Kaplan,
MD\textsuperscript{6}, Archana Ramireddy, MD\textsuperscript{7}; Samuel
Omotoye, MD\textsuperscript{8}

\begin{enumerate}
\tightlist
\item
  Colorado College, Colorado Springs, CO, 80946, USA
\item
  University of Texas Southwestern Medical Center, Dallas, TX, 75390,
  USA
\item
  Centra Health, Centra Lynchburg General Hospital and Centra Specialty
  Hospital, Lynchburg, VA
\item
  University of Florida, Department of Biostatistics, Gainesville, FL
  32611, USA
\item
  Kaiser Permanente, Santa Clara Medical Center, Santa Clara, CA 95051
\item
  Banner Heart Hospital, 6750 E Baywood Ave, Mesa, AZ 85206
\item
  Cedars Sinai, Los Angeles, CA
\item
  Cleveland Clinic, Cleveland, OH 44195
\end{enumerate}

\emph{Data Availability Statement:} Data available from corresponding
author upon request.

\emph{Funding:} Research reported in this publication was supported by
the National Heart, Lung, And Blood Institute of the National Institutes
of Health under Award Number R44HL158375 (the content is solely the
responsibility of the authors and does not necessarily represent the
official views of the National Institutes of Health)

\emph{Conflict of Interest Disclosure:} William Zagrodzky, Julie Cooper,
and Christopher Joseph have interned with Attune Medical; Babette
Brumback performs statistical consulting for Attune Medical; Erik
Kulstad has equity and employment in Attune Medical; all other authors
have no conflicts to disclose.

\emph{Ethics approval} : Reviewed and determined exempt by Advarra IRB
\#Pro00066277.

\emph{Corresponding author:} William Zagrodzky,
William.Zagrodzky1@gmail.com, 300 Huff Heritage Ln, Christiansburg, VA
24073, USA.

\emph{Author Emails:}

* William Zagrodzky - William.Zagrodzky1@gmail.com * Julie Cooper -
julie.cooper@utsouthwestern.edu * Christopher Joseph -
christopher.joseph@utsouthwestern.edu * Matthew Sackett -
matthew.sackett@centrahealth.com * Jose Silva -
jose.silva@centrahealth.com * Rich Kuk - richard.kuk@centrahealth.com *
Julia McHugh - julia.mchugh@centrahealth.com * Babette Brumback -
bbstatconsulting@gmail.com * Shirley Park -
\emph{shirley.x.park@kp.org}* Robert Hayward -
\emph{robert.m.hayward@kp.org}* Taresh Taneja -
\emph{taresh.taneja@kp.org}* Andrew Vu - \emph{andrew.a.vu@kp.org}*
Taylor Liu - \emph{taylor.i.liu@kp.org}* Erik Kulstad -
erik.kulstad@utsouthwestern.edu * Andrew Kaplan - ajkmdep@yahoo.com *
Archana Ramireddy - \emph{archana.ramireddy@cshs.org}* Samuel Omotoye -
omotoye@yahoo.co.uk

\textbf{Abstract}

\textbf{Key Words:}

Esophageal Cooling

Lab Throughput Efficiency

Pulmonary Vein Isolation

Radiofrequency Ablation

Esophageal Injury

Atrial Fibrillation

\textbf{Introduction} : Proactive esophageal cooling has been FDA
cleared to reduce the likelihood of ablation-related esophageal injury
resulting from radiofrequency (RF) cardiac ablation procedures. Data
suggest that procedure times for RF pulmonary vein isolation (PVI) also
decrease when proactive esophageal cooling is employed instead of
luminal esophageal temperature (LET) monitoring. Reduced procedure times
may allow increased electrophysiology (EP) lab throughput. We aimed to
quantify the change in EP lab throughput of PVI cases after the
introduction of proactive esophageal cooling.

\textbf{Methods} : EP lab throughput data were obtained from three
electrophysiology groups. We then compared EP lab throughput over equal
time frames at each site before (pre-adoption) and after (post-adoption)
the adoption of proactive esophageal cooling.

\textbf{Results} : Over the time frame of the study, a total of 2,498
PVIs were performed over a combined 74 months, with cooling adopted in
September 2021, November 2021 and March 2022 at each respective site. In
the pre-adoption time frame, 1,026 PVIs were performed using a
combination of LET monitoring with the addition of esophageal deviation
when deemed necessary by the operator. In the post-adoption time frame,
1,472 PVIs were performed using exclusively proactive esophageal
cooling, representing a mean 43\% increase in throughput (p \textless{}
0.0001), despite the loss of two operators during the post-adoption time
frame.

\textbf{Conclusion} : Adoption of proactive esophageal cooling during
PVI ablation procedures is associated with a significant increase in EP
lab throughput, even after a reduction in total number of operating
physicians in the post-adoption group.

\textbf{Central Illustration:}\selectlanguage{english}
\begin{figure}[H]
\begin{center}
\includegraphics[width=0.70\columnwidth]{figures/image1/image1}

\end{center}
\end{figure}

\textbf{Introduction}

Atrial fibrillation (AF) is the most common form of arrhythmia diagnosed
in the United States today.\textsuperscript{1} With the incidence of AF
rising and the population continuing to age, \textsuperscript{2} the
demand for pulmonary vein isolation (PVI) has steadily
increased.\textsuperscript{3-5} As a result, waiting lists for PVI
procedures have lengthened.\textsuperscript{6,7} Tools or techniques
that increase electrophysiology (EP) lab throughput may help alleviate
this constraint.

A dedicated device for proactive esophageal cooling has recently
received clearance from the US Food and Drug Administration (FDA) to
reduce the likelihood of ablation-related esophageal injury resulting
from radiofrequency (RF) cardiac ablation
procedures.\textsuperscript{8}With increasing adoption of this safety
device, additional findings have been reported with its use. For
example, beyond the reduction in ablation-related esophageal injury,
adoption of cooling has been associated with significantly reduced
procedural duration, improved long-term outcome, and a reduction in
fluoroscopy requirements when compared to PVI ablations performed under
luminal esophageal temperature (LET) monitoring.\textsuperscript{9-16} A
multi-site study of 373 patients found that median procedure time was
reduced from 141 {[}IQR 104 to 174{]} minutes with LET monitoring to 100
{[}IQR 84 to 122{]} minutes with proactive cooling, representing a
reduction of 41 minutes, or 29.1\% of total procedure time
(p \textless{} .001).\textsuperscript{17} Similar trends in reductions
in procedure durations have been observed at a variety of different EP
groups across the country upon adoption of cooling. Shorter procedures
may help improve patient safety by minimizing the additional risk that
comes with prolonged time under anesthesia \textsuperscript{18} and may
also allow more procedures to be completed.\textsuperscript{19}

Although proactive esophageal cooling reduces procedure duration, its
potential influence on EP lab throughput has not been examined. This
study aimed to quantify the change in EP lab throughput of PVI cases
following the introduction of proactive esophageal cooling using a
dedicated esophageal cooling device across three different EP groups.

\textbf{Materials and Methods}

\emph{Study Design and Setting}

This was a sub-study of a larger retrospective review of prospectively
collected data (Advarra IRB \#Pro00066277). All patients undergoing left
atrial ablation for the treatment of AF with PVI over the specified time
frame were included in the study. Data from three EP labs in hospital
systems were collected over equal time frames before (pre-adoption) and
after the adoption (post-adoption) of cooling. In the pre-adoption time
frame, LET monitoring (with esophageal deviation when selected by the
operator) was used as a means of esophageal protection. In the
post-adoption time frame, proactive esophageal cooling (ensoETM\selectlanguage{ngerman}®, Attune
Medical, Chicago, IL) was adopted in September 2021, November 2021, and
March 2022 at each respective site in place of LET monitoring or
deviation.

The analysis period was divided into two separate time frames with
equivalent duration: pre-adoption of proactive esophageal cooling, and
post-adoption of proactive esophageal cooling. Despite the loss of two
operators in the post-adoption phase of the study, this design enabled
comparison of procedural volumes between the two time frames while
keeping location and patient demographics consistent throughout the
study.

\emph{Data Analysis}

The total number of procedures completed in each equivalent time frame
were compared to determine the difference between procedure volumes
accomplished with proactive cooling and without it. Statistical
significance of the increase in rate was assessed assuming that the
number of procedures before and after cooling followed the Poisson
distribution with equal rate parameters; we used the two-sided level
0.05 exact test implemented via the poisson.test function in R. This
function also provided a 95\% confidence interval (CI) for the rate
ratio.

\textbf{Results}

In total, 2,498 patients underwent PVI ablations over a combined 74
months across 3 sites. No operators were added during the months after
adoption, and no new lab space was opened, but two sites lost one
operator each during their post-adoption phase.

\emph{Procedural details}

Procedural methods and approaches used for left atrial PVI ablations in
this site reflect those used by most hospitals performing atrial
ablations in the US. All patients in the study were put under general
anesthesia. Wide area circumferential PVI, additional posterior wall
isolation, mitral isthmus lines, and cavotricuspid isthmus lines were
employed depending on patient need or physician preference. Patients
were given heparin with a targeted active clotting time
\textgreater{}300 seconds. Three-dimensional geometry and
Electro-anatomical mapping were obtained using the CARTO mapping system
(Biosense Webster, Inc., Diamond Bar, CA). All operators used irrigated
contact force sensing catheters (ThermoCool SmartTouch Surround Flow
(STSF) catheter, Biosense Webster, Inc., Diamond Bar, CA). Power
settings utilized a high-power short duration (HPSD) approach, using 40
W to 50 W power. A Visitag Surpoint\textsuperscript{®} ablation index
(Biosense Webster, Inc.) was targeted to 350 to 400 units on the
posterior wall, and 450 to 550 units on the anterior wall, ridge and
septum. Throughout the duration of this analysis, there were no changes
in equipment usage or ablative technique, other than the adoption of
proactive esophageal cooling, and the abandonment of LET monitoring
and/or esophageal deviation.

\emph{Esophageal Protective Measures}

In the pre-adoption cohort, single sensor (various manufacturers) or
multi-sensor LET monitoring (CIRCA Scientific, S-cath, Englewood, CO)
was utilized for all patients. In all three sites, esophageal deviation
(EsoSure Esophageal Retractor, Boynton Beach, FL) was also utilized in
select cases. In the procedures that underwent multi-sensor LET
monitoring, the probe was placed under fluoroscopic guidance and was
subsequently used to monitor the temperature of the esophagus throughout
the procedure. When the esophagus reached a temperature of 39°C, RF was
immediately discontinued and the area was allowed to cool to the initial
baseline temperature of that location as recorded on the LET monitor, or
to a temperature of 36.5°C. In cases using single sensor probes, the
temperature probe was repositioned as needed during the ablation to
optimally position the temperature sensor opposite the RF catheter.
While awaiting return to equilibrium or baseline temperature, energy was
typically applied to another region of the atrium.

In the post-adoption phase, procedures utilized proactive cooling
(ensoETM®, Attune Medical, IL) as a means of esophageal protection
instead of LET monitoring or esophageal deviation. The ensoETM is a
single-use device that consists of a closed system silicone tube that is
placed into the esophagus prior to the delivery of RF energy. Distilled
water circulates through the device at a rate of 2.4 L /minute and a
temperature-controlled heat exchanger keeps the water at a temperature
of 4°C throughout the procedure, which in turn cools the esophagus. The
device has been increasingly adopted for use as a means of esophageal
protection, with over 60,000 cases completed to
date.\textsuperscript{11,12,14,15} In September, 2023, the device
received marketing authorization from the FDA to reduce the likelihood
of ablation-related esophageal injury resulting from radiofrequency
cardiac ablation procedures. Due to the nature of the device, there is
no temperature sensor, and thus, no need for the interruption of RF
delivery due to local overheating or temperature alarms. Placement of
the device is analogous to that of the standard orogastric tube which it
replaces, and no repositioning is required once the device is confirmed
to be in proper place by either fluoroscopy or intracardiac
echocardiography. Because of the insulating effect of the layers of the
fibrous pericardium, serous fluid layer, and pericardial fat, no
degradation in transmurality is seen on the intended lesions placed in
the left atrium.\textsuperscript{19,20}

\emph{Throughput data}

In the pre-adoption period, 1,026 procedures were completed, while 1,472
procedures were completed in the post-adoption period. Site number 1 saw
an increase from 325 cases to 488 cases, representing a rate ratio of
1.50 (95\% CI 1.30 to 1.73, p \textless{} 0.0001). The second site
increased from 560 patients to 672 patients, representing a rate ratio
of 1.2 (95\% CI 1.07 to 1.34, p = 0.0016). Throughput at the third site
increased from 141 cases to 312, representing a rate ratio of 2.21 (95\%
CI 1.81 to 2.72, p \textless{} 0.0001). These data are summarized in
Table 1, with differences shown graphically in Figure 1. Procedure time
reductions across sites ranged from 10\% to 40\%.\selectlanguage{english}
\begin{longtable}[]{@{}llllll@{}}
\toprule
& \textbf{Cases Pre-Adoption} & \textbf{Cases Post-Adoption} &
\textbf{Rate Ratio} & \textbf{95\% CI} & \textbf{p-value}\tabularnewline
\textbf{Site 1} & 325 & 488 & 1.50 & (1.30, 1.73) & p \textless{}
0.0001\tabularnewline
\textbf{Site 2} & 560 & 672 & 1.20 & (1.07, 1.34) & p =
0.0016\tabularnewline
\textbf{Site 3} & 141 & 312 & 2.21 & (1.81, 2.72) & p \textless{}
0.0001\tabularnewline
\bottomrule
\end{longtable}

\textbf{Table 1:} Summary of results.

Therefore, the switch to proactive esophageal cooling was associated
with an overall 43\% increase (rate ratio of 1.43, P \textless{} 0.0001)
in EP lab throughput across the three hospitals, with a 95\% CI of 1.32
to 1.56, despite the loss to different practices of one operator each in
two of the three sites during the post-adoption period. Procedure time
reductions across sites ranged from 10\% to 40\%.\selectlanguage{english}
\begin{figure}[H]
\begin{center}
\includegraphics[width=0.70\columnwidth]{figures/image2/image2}

\end{center}
\end{figure}

\textbf{Figure 1:} Bar graph representing patient throughput in the
pre-adoption and post-adoption cohorts. ``Pre-Adoption'' is defined as
the time frame where LET monitoring or a combination of LET monitoring
and esophageal deviation was employed. ``Post-Adoption'' is defined as
the time frame when proactive cooling alone was used to protect the
esophagus. The switch to proactive esophageal cooling was associated
with a 43.5\% increase (P \textless{} 0.0001) in EP lab throughput.

\textbf{Discussion}

Proactive esophageal cooling was recently cleared by the FDA to reduce
the likelihood of ablation-related esophageal injury resulting from RF
cardiac PVI ablation procedures, with a large multicenter review of over
25,000 patients showing significant reductions in atrioesophageal
fistula formation associated with proactive esophageal
cooling.\textsuperscript{8,11} In this first formal analysis of the
changes in EP lab throughput associated with the adoption of proactive
esophageal cooling, we found that the adoption of proactive esophageal
cooling was associated with a 43.5\% increase in EP lab throughput when
compared to the throughput achieved with LET monitoring and esophageal
deviation. Moreover, this increase occurred despite the loss of one
operator each in two of the three sites analyzed. This increased lab
throughput is attributed to the reduced procedural duration achieved
with the use of proactive esophageal cooling.

Large reductions in procedure time have been found with the use of
proactive esophageal cooling. A study of 373 patients across two
hospital systems found that of the 198 procedures employing LET
monitoring the average procedure duration was 146 \selectlanguage{ngerman}± 51 minutes, while
the 175 cases that employed proactive esophageal cooling were
significantly shorter (p \textless{} 0.001) at 110 ± 39 minutes,
representing a 24.7\% (36 minute) reduction in procedure
duration.\textsuperscript{9,10} A study of 2,280 patients that included
academic medical centers, community hospitals, and an integrated
healthcare delivery system found that patients treated with proactive
esophageal cooling had procedures that were on average 60 minutes
shorter (34.7\% reduction) when compared to procedures employing LET
monitoring (p = 0.001).\textsuperscript{21} Of the 928 patients treated
with LET monitoring, the mean procedure duration was 173 ± 73 minutes,
while the 1,352 cases using proactive esophageal cooling had a mean
procedure duration of 113 ± 51 minutes.\textsuperscript{21} Reduced
procedure times result from the elimination of the need to react to
local overheating conditions that occur with LET monitoring, which
generally requires pausing the RF delivery and awaiting temperature
equilibration and/or repositioning the RF catheter to ablate in a
different region while the overheated site
cools.\textsuperscript{10}With proactive esophageal cooling, overheating
is eliminated, allowing a consistent point-to-point lesion progress
without interruption.

Increased EP lab throughput via the adoption of proactive esophageal
cooling may facilitate reduction of patient
backlog.\textsuperscript{6,19} Improving throughput can lead to shorter
patient wait times between scheduling and receiving treatment, an
important aspect of reducing morbidity and risk of developing more
persistent atrial fibrillation associated with delay in receiving
care.\textsuperscript{22} By reducing wait time, patient outcomes may
therefore improve. In addition to reducing patient wait times, shorter
procedure times have been associated with improved overall outcome, as
longer procedures are often associated with a higher likelihood for
complications.\textsuperscript{18}

\emph{Limitations}

Confounders may exist in any non-blinded retrospective data set.
However, the use of similar durations of time before and after adoption
at sites that did not add new operators, with a large effect size seen
across three distinct hospital sites, suggests that the influence of
unmeasured confounders may be limited. Although retrospective, these
data reflect the objective endpoint of actual procedure volumes. In the
months prior to this analysis, regulations surrounding
COVID-19\textsuperscript{23,24} impacted procedural volumes and
caseloads across a variety of surgical specialties; however, procedure
volumes at the study sites had generally returned to normal by the
beginning of the study, consistent with trends seen at the national
level.\textsuperscript{25,26} We did not acquire demographic or
comorbidity data for this analysis; however, it is unlikely that there
were significant demographic differences between each group. Study sites
remained consistent through the analysis period, no major demographic
transformations occurred at the sites, and in general, a trend of
increasing age and comorbidity burden among patients undergoing AF
ablation exists, which would be expected to bias against the
post-adoption cohort.\textsuperscript{27,28}

Operator experience can affect procedural efficiency, but physicians in
this analysis were generally experienced or even senior operators with
several years out of practice completed. As such, marginal gains in
efficiency over time are likely to be minimal and of limited
contribution to the findings reported.

\textbf{Conclusion}

Adoption of proactive esophageal cooling during PVI ablation procedures
is associated with a significant increase in EP lab throughput, even
after a reduction in total number of operating physicians in the
post-adoption group.

\textbf{References}

1. Lippi G, Sanchis-Gomar F, Cervellin G. Global epidemiology of atrial
fibrillation: An increasing epidemic and public health
challenge.\emph{Int J Stroke.} 2021;16(2):217-221.

2. Kornej J, Borschel CS, Benjamin EJ, Schnabel RB. Epidemiology of
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Insights.\emph{Circ Res.} 2020;127(1):4-20.

3. McCarthy PM, Cox JL, Kislitsina ON, et al. Surgery and Catheter
Ablation for Atrial Fibrillation: History, Current Practice, and Future
Directions. \emph{J Clin Med.} 2021;11(1).

4. Andrade JG, Deyell MW, Macle L, et al. Progression of Atrial
Fibrillation after Cryoablation or Drug Therapy. \emph{N Engl J
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5. Kneeland PP, Fang MC. Trends in catheter ablation for atrial
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6. Morin DP, Krahn AD, Kusumoto F, et al. Heart Rhythm Society's survey
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7. Creta A, Ventrella N, Providência R, et al. Same-day discharge
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8. Attune Medical's ensoETM Granted FDA De Novo Marketing Authorization
to Reduce the Likelihood of Ablation-related Esophageal Injury Resulting
from Radiofrequency Cardiac Ablation Procedures. {[}press release{]}.
Business Wire14 September 2023.

9. Cooper J, Joseph C, Zagrodzky J, et al. Active esophageal cooling
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time reduction associated with active esophageal cooling during
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11. Sanchez J, Woods C, Zagrodzky J, et al. Atrioesophageal Fistula
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12. Tschabrunn CM, Attalla S, Salas J, et al. Active esophageal cooling
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13. Leung LW, Gallagher MM, Santangeli P, et al. Esophageal cooling for
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14. Leung L, El Batran A, Dhillon G, et al. Oesophageal thermal
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15. Leung LWM, Akhtar Z, Sheppard MN, Louis-Auguste J, Hayat J,
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16. Zagrodzky J, Bailey S, Shah S, Kulstad E. Impact of Active
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18. Cheng H, Clymer JW, Po-Han Chen B, et al. Prolonged operative
duration is associated with complications: a systematic review and
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19. Joseph C, Cooper J, Sikka R, et al. Improved hospital discharge and
cost savings with esophageal cooling during left atrial ablation.\emph{J
Med Econ.} 2023;26(1):158-167.

20. Mercado Montoya M, Gomez Bustamante T, Berjano E, et al. Proactive
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