Comparison of Intraoperative Heart Rate and Respiratory Rate Acquired Via ATLASense Raphael Polymonitor and Standard Intraoperative Monitors
Phase: NA
Conditions: Intraoperative Monitoring
Sponsor: Henry Ford Health System

 
 
 
 
 
 
Comparison of Intraoperative Heart Rate and Respiratory Rate Acquired 
Via ATLASense Raphael PolyMonitor and Standard Intraoperative Monitors 
 
 
 
NCT05291949 
 
 
Protocol Version 3.0, 2-3-2022 
 

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STUDY TITLE:
 
Comparison of Intraoperative Heart Rate and Respiratory Rate 
Acquired Via ATLASense Raphael PolyMonitor and Standard 
Intraoperative Monitors
1. STUDY AIM, BACKGROUND, AND DESIGN ABSTRACT 
Vital signs are the objective foundation by which health care providers base clinical 
decisions. Thus, changes in vital signs serve as an important indicator of physiologic 
decline. To efficiently monitor for patient deterioration, we may benefit from technical 
innovation which improves upon traditional surveillance and reporting of these critical 
patient values. New remote monitoring technologies offer a method of obtaining 
continuous and comprehensive surveillance of patient vital signs, which can be 
transmitted to a remote working station for display and analysis 1. Indeed, investigation 
into the accuracy of wireless monitoring devices in reporting key parameters such as 
heart rate (HR) and respiratory rate (RR) as compared to traditional monitoring have 
shown some promising results 1–3. 
The ATLASense RAPHAEL PolyMonitor is an investigational wearable and wireless 
patient monitoring device. The monitor can be attached to a patient’s chest, and collect 
continuous physiological signals including HR, RR, skin temperature, body movement, as 
well as non-invasive blood pressure (NIBP) and transmit this information remotely for 
display and analysis. Ultimately, this PolyMonitor may be able to process multiple 
physiologic signals simultaneously for early detection and predictive modeling of patient 
physiologic deterioration, change the way alerts are transmitted to clinicians, reduce 
infection risk of multiple monitors reused on patients, and extend perioperative 
physiologic monitoring beyond the operating room and recovery areas to a patients home. 
While this monitor has significant potential to improve the efficiency of patient monitoring, 
it has yet to undergo validation studies.
In this observational comparison study, we aim to compare the HR and respiratory RR 
of intraoperative surgical patients simultaneously recorded by standard intraoperative 
monitors and the ATLASense RAPHAEL PolyMonitor. We also aim to determine degree 
of data loss, data gap duration, and validate the PolyMonitor alert system for tachycardia 
and bradycardia. Additional parameters of non-invasive blood pressure (NIBP) and body 
temperature will also be compared between the PolyMonitor and standard intraoperative 
 
APPROVED
February 04, 2022
INSTITUTIONAL REVIEW BOARD

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monitors. Finally, this study will provide insight into the logistics of intraoperative use of 
the PolyMonitor. 
The ATLASense Raphael PolyMonitor will be placed on the patient’s left chest mid 
sternal line in the operating room.  Traditional physiologic monitors described above will 
also be placed on the patient in the operating room. Data will be collected via the 
ATLASense system and through the traditional operating room monitors, and this data 
will be time matched through synchronization of the monitors post hoc. The time matched 
data pairs will undergo statistical analysis post hoc.
We anticipate that this study will validate the intraoperative HR and RR measured 
through the ATLASense Raphael PolyMonitor, providing adequate data points for 
statistical analysis with 95% limits of agreement, bias, and data loss/gaps. Success is 
also the logistical lessons learned for using this monitor in the intraoperative setting.
This study will provide a foundation for further investigation into the use of the 
ATLASense Raphael PolyMonitor as a tool for early detection and predictive modeling of 
patient physiological deterioration. With further study, this device has the potential to 
replace multiple traditional monitors, provide individualized data capture to build a 
predictive model for each patient and may extend perioperative physiologic monitoring 
beyond the operating room and recovery areas to a patient’s home. 
2. SUBJECT POPULATION AND ELIGIBILITY
Subject Population:
Adult patients who are scheduled to undergo general anesthesia during their elective 
surgery at Henry Ford Hospital - Main Campus between October 2021 and December 
2021. 
Inclusion criteria:  
English speaking
Adult males or females (above the age of 18)
Scheduled to undergo general anesthesia during elective surgery
Exclusion criteria:
Pregnant adult female

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Thoracic surgery
Left lateral decubitus positioning required during procedure
Surgery involving the left flank, or requiring surgical field involving the left flank
Surgery involving the left chest, or requiring surgical field involving the left chest
Allergy to adhesives
Open wound, rash, or sore involving the left chest
Presence of cardiac defibrillator, or pacemaker 
Enrollment 
The electronic medical record available of subjects scheduled for elective procedures 
at Henry Ford Hospital – Main Campus will be reviewed by the study team to screen 
subjects for eligibility. Minimal necessary variables that need to be obtained include: age, 
gender, pregnancy status, BMI, planned procedure, associated diagnosis, allergies, and 
co-morbidities (Hypertension, Congestive Heart Failure, Chronic Obstructive Pulmonary 
Disease, Diabetes Mellitus, ASA status). Subjects will be called via telephone at least one 
week prior to their procedure to briefly introduce the study to them. For in-patients, it is 
possible that a study team member will visit their location in the hospital to introduce the 
study and review the Informed Consent Form with them in the week prior to their surgery. 
If interested, they will be sent the Informed Consent Form via email or mail (whatever 
their preference) to ensure that they have adequate time to read the consent form and 
ask questions. Patients will be consented in person prior to their elective procedure and 
given a copy of the signed consent form. 
3. STUDY PROCEDURES
Study Design and Outcomes
This will be a prospective observational study comparing HR and RR of 
intraoperative surgical patients simultaneously recorded by standard intraoperative 
monitors and the ATLASense RAPHAEL PolyMonitor. Funding for this study will be 
provided internally. This study will fall under regulatory oversight by the FDA. 
This study will consist of an initial chart review of patients scheduled to undergo 
elective procedures at Henry Ford Hospital – Main Campus from October 2021, to 
December 2021. The study team will review their medical record in EPIC prior to their 
scheduled procedure and screen them to ensure that they meet all eligibility 
requirements. Patients will be contacted at least one week prior to their scheduled 

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procedure to provide them with a brief introduction to the study.  If they are interested, 
they will be sent an Informed Consent Form via mail or email (whichever is their 
preference).  This will ensure that the patients have adequate time to review the consent 
form and ask questions prior to their procedure. They will then be consented in person 
prior to their procedure and given a copy of the signed consent form.  
Our primary study aim is to determine if the ATLASense RAPHAEL PolyMonitor 
can reliably measure intraoperative HR and RR as compared to traditional intraoperative 
monitors. In order to evaluate this aim, our primary outcome will be bias and precision 
(95% limits of agreement) of HR and RR of the PolyMonitor compared with the traditional 
monitors. It is hypothesized that the ATLASense RAPHAEL PolyMonitor will provide HR 
and RR measurements within ± 10% of the reference monitor or ± 3 breaths/min or ± 5 
beats/min 4. 
A secondary outcome that will examined include technical reliability in terms of 
data loss occurrences, and data gap duration. Additional secondary outcomes include 
reliability in detecting bradycardia and tachycardia, as well as bias and precision (95% 
limits of agreement) of skin temperature and NIBP of the PolyMonitor compared with 
traditional monitors. 
Further lessons include the logistics of employing this PolyMonitor in intraoperative 
setting including device placement, surgical practices that may impede data collection 
(body placement, etc), device placement, patient feedback on wearable, and patient 
positioning considerations.  
Data Collection
The information that will be pulled from patient charts in EPIC is as follows:
Age
Gender
Race
Height
Weight 
Pregnancy status
BMI
Planned surgery and associated diagnosis
Allergies

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Co-morbidities
ASA status
On the day of surgery, the ATLASense RAPHAEL PolyMonitor will be placed on 
the patient’s left chest mid sternal line in the operating room by the anesthesia provider. 
Traditional physiologic monitors including the GE E-PSMP-00 Monitor/Datex Ohmeda 
Aisys CS2: EKG HR, Ventilator RR, End Tidal CO2 RR, blood pressure cuff, *** core 
temperature probe will also be placed on the patient in the operating room.  
Data acquisition will include: HR, RR, NIBP, core body temperature, data loss 
events (instances when data was not recorded/saved for any reason by the polymonitor 
or other monitors) and duration of data gaps, bradycardic events, and tachycardic events. 
Acquisition of data from the ATLASense PolyMonitor will be confirmed after the device is 
applied. Data will initially by tracked via medical record number (MRN). Following data 
acquisition, subjects will be deidentified using a random number generator to assign data 
sets for further data tracking. 
Data will be collected via the ATLASense system and through the traditional 
operating room monitors, and this data will be time matched through synchronization of 
the monitors post hoc.  Data collection intervals will be every 1 minute starting prior to 
induction of anesthesia and ending at the time of intraoperative monitor removal in the 
operating room.  The ATLASense PolyMonitor will be removed at the same time as 
traditional physiologic monitors. 
ATLASense RAPHAEL PolyMonitor
The ATLASense RAPHAEL PolyMonitor is a small, non-intrusive, wireless, wearable 
multi-sensor device, attached to the patient’s torso either with adhesive disposable patch 
or as a smart shirt. It continuously collects multiple physiological signals, analyzes them 
and transmits them to the ATLASense server. The PolyMonitor is composed of a 
rechargeable lithium polymer battery (3.6 Volts, 370 milliamp hour), an independent 
charger (5 volt input via mini USB/USB cable) which employs a universal 90-240 VAC 
50/60 Hz to 5VDC converter and four FDA-approved hydrogel electrodes. The device has 
safe fault limit on electrical current which exceeds regulatory requirements.
The system enables monitoring a multiple array of physiological, postural and 
emotional parameters.  For this study, the Heart rate (HR) and Respiration rate (RR) 
derived parameters will be calculated and updated every second, stored in internal 

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memory, and transmitted.  Measurements and alerts are transmitted via a low-power 
radio protocol (BT 4.2 Low Energy) to hotspots (“gateways” connected to the hospital 
communication network). The data is sent to ATLASense central server and to the 
healthcare service provider’s server connected with the electronic medical record.
ATLASense RAPHAEL PolyMonitor – HR Detection
The electrocardiogram is recorded and processed to calculate the average HR by 
analyzing a single-lead electrocardiogram, which is preprocessed first to filter the raw 
electrocardiogram signal in order to minimize noise due to motion and muscle artifacts.  
Heart rate is measured using an algorithm developed by ATLASense.
The algorithm checks electrodes’ contact to assure credibility, detects the R wave, 
computes several valid interbeat intervals, and computes the running HR with low 
latency. HR is calculated by computing inter-beat intervals (IBI), limiting IBI to one in 
every 300 mSec before the next beat (refractory period). The average HR is acquired by 
calculating the reciprocal of the average of 4 IBIs.  Accuracy of resting HR is reported to 
be +/-1% or +/- 2 BPM, whichever is greater, and range of detection is reported to be 
from 30-240 BPM.
ATLASense RAPHAEL PolyMonitor – RR Detection
The PolyMonitor incorporates three independent respiration measures for 
increased reliability: Piezoelectric respiration sensor with two, additionally derived 
respiration measures from two biopotential electrodes concurrently monitoring the torso 
ECG and EMG. The algorithm excludes from the calculation segments that are corrupted 
by motion artifacts or other irregular patterns. Accuracy of resting RR is reported to be 
+/- 5% or +/- 1 Breaths/Min, whichever is greater. A default RR alert is generated for no 
single breath in a 10 second period. 
ATLASense RAPHAEL PolyMonitor – NIBP detection
The ATLASense RAPHAEL PolyMonitor detects NIBP at up to 1 minute intervals, and 
can derive the NIBP as an average over multiple measurements, or as a single NIBP 
measurement. The latency period between measuring these intervals and calculating an 
average for data recording and display is ~ 1 second when employing a local server.
ATLASense RAPHAEL PolyMonitor – Temperature detection
The ATLASense RAPHAEL PolyMonitor detects skin temperature at up to 1 minute 
intervals, and derives measurements as an average based on multiple interval 
measurements. The latency period between measuring these intervals and calculating 
an average for data recording and display is ~ 1 second when employing a local server.

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CARESCAPE™ Monitor B850 - HR Detection
This multiparameter high acuity patient monitor is intended for use in multiple areas 
within a health care facility. Within the perioperative setting it is indicated for monitoring 
of multiple different hemodynamic parameters. However, for our study we will be 
acquiring data from its ECG monitoring function, and calculated HR. The heart rate will 
be measured at 1 minute intervals and then compared with time-matched HR acquired 
through the ATLASense PolyMonitor. 
GE AIsys CS2™ - RR Detection
The Aisys CS2 is functionally integrated ventilation, respiratory monitoring, and 
breathing system. Module bays allow for the physical integration of legacy Datex-Ohmeda 
patient monitors and supports mounting of other GE Healthcare monitors, including the 
CARESCAPE™ Monitor B850. The Aisys CS2 Anesthesia System is intended to provide 
general inhalation anesthesia and ventilatory support to a wide range of patients. 
Respiratory rate is calculated with this system from the frequency of peak (end tidal) CO2 
measurements per minute. A breath is defined as a change in the CO2 signal that 
exceeds 1% (8 mmHg). All concentrations are measured and displayed breath by breath.
CARESCAPE™ Monitor B850 – Non-Invasive Blood Pressure Measurement  
The CARESCAPE Monitor B850 employs the oscillometric technique for blood 
pressure measurement. In brief, this technique involves inflation of the cuff to a preset 
pressure. The pressure is then gradually reduced. With every arterial pulse wave there is 
a small rise and fall in volume within the vessel. This creates an increase and subsequent 
decrease in the pressure within the encircling blood pressure cuff, which can be detected 
using a solid-state transducer 5. Various proprietary algorithms then calculate the mean 
arterial pressure (MAP), diastolic, and systolic blood pressures. The CARESCAPE™ 
Monitor B85 employs the use of the DINAMAPTM SuperSTAT advanced NIBP algorithm 
from GE Healthcare. 
CARESCAPE™ Monitor B850 – Arterial Line Blood Pressure Measurement  
In patients with an arterial line placed during surgery, the CARESCAPE™ Monitor 
B850 will be used to monitor blood pressure.  The CARESCAPE™ Monitor B850 employs 
an invasive blood pressure module which is able to transmit data obtained from the 
Arrow® 
arterial 
catheterization 
device. 
the 
Arrow® 
ASK-4500-HFH3 
arterial 
catheterization device permits access to peripheral arterial circulation, and allows for 

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hydraulic coupling between the arterial circulation and a Wheatstone bridge piezoresistive 
transducer. This transducer converts the change of pressure transmitted within the 
arterial catheter with each heart contraction into a change of current which can then be 
displayed on the CARESCAPE™ monitor. The monitor filters the raw signal from the 
transducer and converts it into a visual waveform. Various proprietary algorithms then 
calculate the mean arterial pressure (MAP), diastolic, and systolic blood pressures.   
CARESCAPE™ Monitor B850 – Temperature Measurement 
The Vyaire M1024215VY temperature sensor is a disposable device which can be 
inserted into a patient’s esophagus and transmit core body temperature measurements 
at 1-minute intervals. The Vyaire M1024215VY has a direct input in order to display 
temperature information on the CARESCAPE™ Monitor B850. 
Project Timeline 
The primary end-point of the study is the collection of 14,303 time-matched HR 
and RR data pairs to power the study for 95% level of agreement (N = 14,303).  This 
would require approximately 238 hours of intraoperative data collection if 1-minute 
intervals are used for time-matched data pairs.  We estimate that 60-70 patients will need 
to be recruited based on surgical procedures with anticipated durations of 2-5 hours. Data 
collection is estimated to take approximately 3 months. Data analysis, and manuscript 
preparation is estimated to take an additional 6 months. 
Protection of Privacy
Subject name and MRN will be recorded out of necessity during subject screening, 
recruitment and data acquisition so that data can be appropriately tracked.  However, the 
PI and Co-investigators will take appropriate steps to minimize risk to the subject and 
ensure protected health information is secured. The information will be de-identified by a 
broker from HFHS Data Analytics prior to being given to the study team for analysis.  The 
identifiable information will be stored in a secure REDCap database and will be destroyed 
as soon as possible after the record maintenance period.  All study data will remain on 
secure HFHS password-protected computers and stored on secure HFHS servers. 

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Statistical Analysis
The data pairs of HR and RR measurements obtained in 1-minute intervals derived 
from the wireless sensors and the traditional physiologic monitors will be analyzed using 
the Bland and Altman method for repeated measurements 6.  The Bland and Altman 
method will also be used to account for within-subject variation by correcting for the 
differences across patients and the variance of differences between the average 
differences. The bias (mean difference) between the ATLASense RAPHAEL PolyMonitor 
sensors and reference monitor and the 95% limits of agreement (± 1.96 SD) will be 
determined for both HR and RR data. 
PolyMonitor bradycardia and tachycardia alert notifications will be time matched 
with the HR measurements from the traditional monitor.  Reliability in determining 
tachycardic and bradycardic events will be assessed by calculating sensitivity, specificity, 
positive predictive value and negative predictive value from paired data. True positive 
tachycardia will be defined as HR > 100 BPM via the traditional monitor.  True positive 
bradycardia will be defined as HR < 60 BPM via the traditional monitor. Based on the data 
points from our primary aim (N=14303), we have 99% power to detect a change in 
sensitivity from 0.5 to 0.8 using a two-sided binomial test and 99% power to detect a 
change in specificity from 0.5 to 0.8 using a two-sided binomial test. The target 
significance level is 0.05. The prevalence of tachycardia and bradycardia is assumed to 
be 0.01 to 0.022,7.
Data pairs for skin temperature and NIBP obtained in 1 to 5 minute intervals 
derived from the wireless sensors and the traditional physiologic monitors will be analyzed 
using the Bland and Altman method for repeated measurements 6.  The Bland and Altman 
method will also be used to account for within-subject variation by correcting for the 
differences across patients and the variance of differences between the average 
differences. The bias (mean difference) between the ATLASense RAPHAEL PolyMonitor 
sensors and reference monitor and the 95% limits of agreement (± 1.96 SD) will be 
determined for both HR and RR data. Sample size calculation was estimated based on 
the primary study aim.  
Technical performance will be analyzed by the duration of data loss and the total 
amount of data loss. Reliability will be defined as the time until the first occurrence of data 
loss (defined as duration of a gap within the data of 2 min, 15 min, 1 hour or 4 hours) and 
the overall amount of data loss. The time to first occurrence of data loss will be analyzed 
with Kaplan-Meier survival plots. Data analysis will be performed by a statistician from the 

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HFHS Public Health Sciences.  
4. ANTICIPATED RISKS 
This study involves minimal risk for participants. The placement of the investigational 
device will not require deviation from standard practices. The risk to the participant 
includes breach of confidentiality in terms of inadvertent or unanticipated release of 
identifying information during the data acquisition process. The identifiable information 
will be stored in a secure REDCap database and will be destroyed as soon as possible 
after the record maintenance period. This risk will be mitigated by limiting data access to 
the principle investigator and co-investigators. Identifying information will be removed as 
soon as possible by a third party after the data acquisition process. All study data will 
remain on secure HFHS password-protected computers and stored on secure HFHS 
servers. 
There is minimal to no risk with regards to placement of the study device. Risk may 
include allergic reaction upon placement of the device electrodes. This risk will be 
mitigated by excluding subjects with a known allergy to skin adhesive, and by monitoring 
the patient’s skin following device placement and removal.   In the event of an allergic 
reaction to the skin adhesive, the device will be removed, data collection will stop, and 
the patient will be treated as appropriate for an allergic reaction.  The incidence will be 
documented in the study REDCap database.  A member of the study team will follow up 
with the patient in recovery.  
5. ANTICIPATED BENEFITS
There are no anticipated direct benefits to the patient. The research will allow for 
validation of the device in obtaining intraoperative heart rate and respiratory rate. The 
data will lay the foundation for further study of this device which may improve upon the 
standard intraoperative monitor and improve perioperative patient monitoring.
6. RENUMERATION/COMPENSATION
No compensation or renumeration will be offered. 
7. COSTS

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There is no additional cost for participants associated with participation in this study.
8. ALTERNATIVES
The alternative is that subjects do not have to participate in the research. 
9. CONSENT PROCESS AND DOCUMENTATION
This study consists of an initial chart review of information that is routinely collected 
as standard of care for all patients undergoing elective surgical procedures. Subjects 
deemed eligible for the study based on inclusion and exclusion criteria will be contacted 
and provided information about the study per a pre-determined telephone script. Subjects 
who are interested in participating will be sent the informed consent documents via mail 
or e-mail (per their preference) at least one week prior to their scheduled procedure. 
Patients will be provided the opportunity to privately ask questions by contacting research 
personnel prior to their scheduled procedure (via contact information provided on the 
informed consent form), as well as on the day of their procedure prior to placement of the 
device in the operating room.  
Patients will be consented prior to their enrollment in the study by research personnel 
when they arrive to the hospital on the day of their procedure and provided with a copy of 
the signed consent.  Physical copies will also be retained and held securely in a locked 
file within the department of anesthesiology office. After data collection is complete, 
records will be retained for the required record maintenance period before being 
destroyed. 
       
10.WITHDRAWAL OF SUBJECTS
The subjects will be withdrawn from the research if the procedure cannot be 
completed for any reason. Subjects will also be withdrawn from the research if they 
indicate a desire to withdraw. If data acquisition has already begun or has been 
completed, data obtained will be destroyed along with any possible identifiers. 
11.PRIVACY AND CONFIDENTIALITY 

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We will be screening patient charts to verify that they meet eligibility requirements for 
the study.  During the data collection period, recorded patient information will be entered 
in a secure REDCap study database containing patient names and medical record 
numbers. Data will be de-identified by a broker from HFHS Data Analytics and assigned 
a numerical code before it will be given to the study team for analysis.  Following data 
collection, this information will be destroyed as soon as possible following the record 
maintenance period and the REDCap database will be deleted.  HIPAA Authorization will 
be obtained prior to the patient’s procedure, at the time of obtaining documented consent.    
12.DATA AND SAFETY MONITORING PLAN
Data will be maintained in a secure REDCap database, and only research staff will 
have access to the data. The PI will check the data for integrity every month. If there are 
discrepancies, this will be discussed with the study team and rectified. Data will be 
monitored on a monthly basis. If there is an issue, Cory McCurry DO MSc will contact IRB 
via email within one week, depending on the nature of the issue.
13.QUALIFICATIONS OF THE INVESTIGATOR(S)
Trevor Szymanski M.D. M.B.A completed his undergraduate degree at the University 
of Michigan, then completed his M.D at Tufts University School of Medicine. He 
completed his anesthesiology residency at Brigham and Women’s Hospital – Harvard 
Medical School, and completed a fellowship in cardiothoracic anesthesiology at 
Massachusetts General Hospital – Harvard Medical School. He completed his Masters of 
Business Administration at the University of Michigan – Stephen M. Ross School of 
Business. 
He has been involved with numerous previous studies8–11, including most recently a 
comparison study examining outcomes of transfemoral transcatheter aortic valve 
replacement using pre-sedation radial versus post-sedation femoral arterial sites for blood 
pressure monitoring12. 
14.REFERENCES

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1.
Breteler, M. J. M. et al. Vital Signs Monitoring with Wearable Sensors in High-risk 
Surgical Patients: A Clinical Validation Study. Anesthesiology 132, 424–439 
(2020).
2.
Breteler, M. J. M. et al. Reliability of wireless monitoring using a wearable patch 
sensor in high-risk surgical patients at a step-down unit in the Netherlands: A 
clinical validation study. BMJ Open 8, e020162 (2018).
3.
Downey, C., Randell, R., Brown, J. & Jayne, D. G. Continuous Versus Intermittent 
Vital Signs Monitoring Using a Wearable, Wireless Patch in Patients Admitted to 
Surgical Wards: Pilot Cluster Randomized Controlled Trial. J. Med. Internet Res. 
20, e10802 (2018).
4.
Ben-Ari, J., Zimlichman, E., Adi, N. & Sorkine, P. Contactless respiratory and 
heart rate monitoring: Validation of an innovative tool. J. Med. Eng. Technol. 34, 
393–398 (2010).
5.
Ramsey, M. 3rd. Noninvasive automatic determination of mean arterial pressure. 
Med. Biol. Eng. Comput. 17, 11–18 (1979).
6.
Bland, J. M. & Altman, D. G. Agreement between methods of measurement with 
multiple observations per individual. J. Biopharm. Stat. 17, 571–582 (2007).
7.
Ruetzler, K. et al. Intra-operative tachycardia is not associated with a composite 
of myocardial injury and mortality after noncardiac surgery. Eur. J. Anaesthesiol. 
36, 105–113 (2019).
8.
Szymanski, T., Maslow, A., Mahmood, F. & Singh, A. Three-Dimensional Imaging 
of the Repaired Aortic Valve. J. Cardiothorac. Vasc. Anesth. 30, 1599–1610 
(2016).
9.
Navas-Blanco, J. R. et al. Severe Mitral Regurgitation Due to a “Folded” Anterior 
Mitral Valve Leaflet After Bentall Procedure Requiring Mitral Valve Replacement. 
J. Cardiothorac. Vasc. Anesth. 32, 1337–1340 (2018).
10.
Maslow, A., Szymanski, T. & Mahmood, F. Three-Dimensional Echocardiographic 
Assessment of a Paravalvular Leak. J. Cardiothorac. Vasc. Anesth. 31, 1308–
1311 (2017).
11.
Szymanski, T., Maslow, A., Mahmood, F. & Singh, A. Three-Dimensional 
Echocardiographic Assessment of Coaptation After Aortic Valve Repair. J. 
Cardiothorac. Vasc. Anesth. 31, 993–1000 (2017).
12.
Cook, S. A. et al. Comparison of Patient Outcomes of Transfemoral Transcatheter 
Aortic Valve Replacement Using Pre-Sedation Radial Versus Post-Sedation 
Femoral Arterial Sites for Blood Pressure Monitoring. J. Cardiothorac. Vasc. 
Anesth. 33, 3303–3308 (2019).

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