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1. Sichuan Da Xue Xue Bao Yi Xue Ban. 2024 Sep 20;55(5):1280-1287. doi: 
10.12182/20240960109.

[Efficacy of Combining Highly Aspherical Lenslets Spectacles With 0.01% Atropine 
Eye Drops in Myopia Control].

[Article in Chinese]

Zhao Y(1)(2)(3), Yang B(1)(2)(3), Li X(1)(2)(3), Ma W(1)(2)(3), Liu L(1)(2)(3), 
Yan N(1).

Author information:
(1)（ 610041） Department of Ophthalmology, West China Hospital, Sichuan 
University, Chengdu 610041, China.
(2)（ 610041） Laboratory of Optometry and Vision Sciences, West China Hospital, 
Sichuan University, Chengdu 610041, China.
(3)（ 610041） Department of Optometry and Vision Sciences, West China School of 
Medicine, Sichuan University, Chengdu 610041, China.

OBJECTIVE: To explore the difference in myopia control efficacy between 
spectacle lenses with highly aspherical lenslets (HAL) combined with 0.01% 
atropine eye drops and spectacle lenses with HAL alone or single vision 
spectacle lenses (SVL) in children and adolescents.
METHODS: A retrospective cohort study was conducted with a total of 105 myopic 
children aged 6-15 years. According to the specific myopia correction and 
control methods of each subject, they were evenly divided into the HAL+0.01% 
atropine (HAL+AT) group, the HAL group, and the SVL group, with 35 subjects in 
each group. Relevant data, such as cycloplegic refraction and axial length (AL) 
at baseline and 12 months after wearing spectacles, were retrieved. One-way 
analysis of variance, or the Kruskal-Wallis test, was used to analyze the 
changes in AL and spherical equivalent refraction (SER) after wearing spectacles 
for 12 months in comparison to those at baseline in the three groups.
RESULTS: There was no statistically significant difference in the baseline 
parameters and duration of wearing spectacles among the three groups (P>0.05). 
After wearing spectacles for 12 months, the changes in SER were －0.13 (－0.25, 
0.00) D, －0.25 (－0.63, －0.25) D, and －0.63 (－1.00, －0.25) D in the HAL+AT group, 
HAL group, and SVL group, respectively; AL elongation in the three groups was 
(0.09±0.11) mm, (0.19±0.16) mm, and (0.34±0.16) mm, respectively. The HAL+AT 
group exhibited slower SER changes (P HAL+AT vs. HAL=0.001, P HAL+AT vs. 
SVL=0.002) and AL elongation (P HAL+AT vs. HAL=0.009, P HAL+AT vs. SVL=0.001) 
than those of the HAL and the SVL groups. Compared with those of the SVL group, 
myopia progression was reduced by 79.4% and AL elongation was slowed down by 
73.5% in the HAL+AT group, while in the HAL group, myopia progression and AL 
elongation were reduced by 60.3% and 44.1%, respectively. According to 
stratified analysis based on age and myopia progression rate, among younger 
children aged 6 to 8 years and older children aged 9 to 15 years, the HAL+AT 
group had a significantly lower proportion of subjects experiencing fast AL 
elongation (AL>0.36 mm/year) and a significantly higher proportion of subjects 
experiencing slow AL elongation (AL≤0.18 mm/year) compared to the SVL group 
(P<0.017).
CONCLUSION: The combination intervention of spectacle lenses with HAL and 0.01% 
atropine eye drops is effective in controlling myopia progression in children 
and adolescents, with better myopia control effect achieved using this 
combination intervention in myopic children of all ages.

© 2024《四川大学学报（医学版）》编辑部 版权所有Copyright ©2024 Editorial Office of Journal of 
Sichuan University (Medical Sciences).

DOI: 10.12182/20240960109
PMCID: PMC11536230
PMID: 39507958 [Indexed for MEDLINE]

Conflict of interest statement: 
利益冲突　本文作者刘陇黔是本刊编委会编委。该文在编辑评审过程中所有流程严格按照期刊政策进行，且未经其本人经手处理。除此之外，所有作者声明不存在利益冲突。


2. Front Ophthalmol (Lausanne). 2024 Oct 23;4:1447558. doi: 
10.3389/fopht.2024.1447558. eCollection 2024.

Comparison of different concentrations atropine in controlling children and 
adolescent myopia: an umbrella review of systematic reviews and meta-analyses.

Chen B(1), Ni Y(1), Chen J(2), Xing S(1), Zhang Z(1).

Author information:
(1)State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Guangdong 
Provincial Key Laboratory of Ophthalmology and Vision Science, Guangdong 
Provincial Clinical Research Center for Ocular Diseases, Sun Yat-sen University, 
Guangzhou, Guangdong, China.
(2)Department of Visual Science, Guangzhou Xinhua University, Guangzhou, China.

PURPOSE: To evaluate the myopia control effect of different concentrations 
atropine in children and adolescent.
METHODS: Meta-analyses and systematic reviews available in the Pubmed, Embase, 
and Cochrane Library databases from the databases' inception to August 2023 were 
searched to evaluate the efficacy and tolerability of different concentrations' 
atropine in controlling myopia progression. Overall effects were performed using 
random-effects model. AMSTAR 2 tool was used to assess the quality of included 
studies. Prespecified outcomes were weight mean difference (WMD) with 95% 
credible interval (95% CI) of annual spherical equivalent refraction (SER) 
changes and annual axial length (AL) changes.
RESULTS: 19 systematic reviews/meta-analyses of different atropine 
concentrations were included in the analysis. 14 studies reported SER changes, 
and 17 reported AL changes. In terms of the studies' overall methodological 
quality level (measured using AMSTAR 2), 1 study was rated high, 7 moderate, 7 
low, and 4 critically low. The 0.01% atropine was found to have statistically 
significance (annual SER change WMD 0.27 [95% CI 0.21 - 0.34] D/year; annual AL 
change WMD -0.09 [95% CI -0.1 to -0.07]) mm/year), 0.05% atropine was preferred 
considering efficacy and tolerability (annual SER change WMD 0.54 [95% CI 0.49 - 
0.58] D/year; annual AL change WMD -0.21 [95% CI -0.12 to -0.02]) mm/year).
CONCLUSIONS: Different atropine concentrations alleviated children and 
adolescent myopia progression. However, higher-quality evidence and further 
investigation are needed to clarify the dose-response relationship, and 
practical guidelines must be developed to determine myopia control efficacy.

Copyright © 2024 Chen, Ni, Chen, Xing and Zhang.

DOI: 10.3389/fopht.2024.1447558
PMCID: PMC11537912
PMID: 39507931

Conflict of interest statement: The authors declare that the research was 
conducted in the absence of any commercial or financial relationships that could 
be construed as a potential conflict of interest.


3. BMJ Case Rep. 2024 Nov 5;17(11):e260861. doi: 10.1136/bcr-2024-260861.

Anterior segment ischaemia following insertion of a PreserFlo Micro-Shunt with 
mitomycin-C for uncontrolled open angle glaucoma.

Ali AIAH(1), Malick H(2).

Author information:
(1)Ophthalmology, University Hospitals of Leicester NHS Trust, Leicester, UK 
ali.i.ali@uhl-tr.nhs.uk.
(2)Ophthalmology, University Hospitals of Leicester NHS Trust, Leicester, UK.

To our knowledge, this is the first report of anterior segment ischaemia after 
PreserFlo Micro-Shunt insertion surgery. Our patient developed anterior chamber 
(AC) activity and keratic precipitates 1 week after surgery. Five weeks after 
surgery, examination revealed a shallow AC, a distorted pupil with posterior 
synechiae and surface iris neovascularisation. Ocular ischaemic syndrome was 
excluded after performing fundus fluorescein angiography and carotid Doppler 
ultrasound. The patient responded well to frequent topical steroids and atropine 
eye drops. 10 weeks postoperatively, the iris neovascularisation had completely 
regressed with a deep and quiet AC and diffuse filtering bleb with an 
intraocular pressure of 10 mm Hg without using any pressure-lowering drops. 
Proposed steps to minimise future incidence of anterior segment ischaemia 
include avoidance of peri-limbal cautery, controlled use of mitomycin-C 
application and avoidance of extensive superior fornix dissection.

© BMJ Publishing Group Limited 2024. No commercial re-use. See rights and 
permissions. Published by BMJ.

DOI: 10.1136/bcr-2024-260861
PMID: 39500586 [Indexed for MEDLINE]

Conflict of interest statement: Competing interests: None declared.


4. Front Pharmacol. 2024 Oct 21;15:1440180. doi: 10.3389/fphar.2024.1440180. 
eCollection 2024.

Effects of atropine on choroidal thickness in myopic children: a meta-analysis.

Yang Y(1), Wei L(1), Wang B(1), Zheng W(1).

Author information:
(1)Ophthalmology Department, Affiliated Hospital of Changchun University of 
Traditional Chinese Medicine, Changchun, China.

BACKGROUND: Atropine is an effective medicine for myopia prevention and control. 
This meta-analysis was conducted to investigate the effects of atropine on 
choroidal thickness (ChT) in children with myopia.
METHODS: Between its inception and 1 June 2023, Medline, Embase, and Web of 
Science were all searched, and only English literature was included. The 
choroidal thickness was the primary study outcome. Axial length, standardized 
equivalent refraction were examined as secondary outcomes. STATA 12.0 was used 
for data extraction and analysis.
RESULTS: A total of 307 eyes were involved in this study to evaluate the effect 
of atropine on ChT, axial length (AL) and standardized equivalent refraction 
(SER) in myopic children. Choroidal thickening was significantly higher in the 
atropine group than in the control group at 1 month (WMD, 6.87 mm, 95% CI, 0.04 
to 13.10, P = 0.049), whereas it was significantly higher in the atropine group 
than in the control group at months 6 (WMD, 10.37 mm, 95% CI, -3.21 to 23.95, P 
= 0.135), 12 (WMD, 15.10 mm, 95% CI, -5.08 to 35.27, P = 0.143) and at final 
follow-up (WMD, 11.52 mm, 95% CI, -3.26 to 26.31, P = 0.127), the differences 
were not statistically significant. At months 1 (WMD, -0.03 mm, 95% CI, -0.04 to 
-0.01, P = 0.003), 6 (WMD, -0.07 mm, 95% CI, -0.01 to -0.03, P = 0.000), 12 
(WMD, -0.13mm, 95% CI, -0.15 to -0.11, P = 0.843), and at final follow-up (WMD, 
-0.08 mm, 95% CI, -0.16 to -0.01, P = 0.127), atropine treatment was able to 
delay the axial elongation. At 1-month follow-up, there was no significant 
difference in the effect of atropine on SER in myopic children compared with the 
control group (WMD, 0.01D, 95% CI, -0.07 to 26.31, P = 0.127), whereas it was 
able to control the progression of refractive status at final follow-up (WMD, 
11.52 mm, 95% CI, -3.26 to 26.31, P = 0.127).
CONCLUSION: Limited evidence suggests that 0.01% atropine causes choroidal 
thickening in myopic children at 1 month of treatment. In the short term, 
choroidal thickness may be a predictor of the effectiveness of atropine in 
controlling myopia in children. 0.01% atropine is effective in controlling 
myopic progression in terms of SER and AL.
SYSTEMATIC REVIEW REGISTRATION: http://www.crd.york.ac.uk/prospero, identifier, 
CRD42022381195.

Copyright © 2024 Yang, Wei, Wang and Zheng.

DOI: 10.3389/fphar.2024.1440180
PMCID: PMC11533146
PMID: 39498339

Conflict of interest statement: The authors declare that the research was 
conducted in the absence of any commercial or financial relationships that could 
be construed as a potential conflict of interest.


5. Cureus. 2024 Oct 3;16(10):e70789. doi: 10.7759/cureus.70789. eCollection 2024 
Oct.

Compact Arterial Monitoring Device Use in Resuscitative Endovascular Balloon 
Occlusion of the Aorta (REBOA): A Simple Validation Study in Swine.

Lussier G(1), Evans AJ(2), Houston I(1), Wilsnack A(2), Russo CM(2), Vietor 
R(3)(2), Bedocs P(3).

Author information:
(1)Department of Medicine, Uniformed Services University of the Health Sciences, 
Bethesda, USA.
(2)Department of Anesthesiology, Walter Reed National Military Medical Center, 
Bethesda, USA.
(3)Department of Anesthesiology, Uniformed Services University of the Health 
Sciences, Bethesda, USA.

Introduction Hemorrhage is the leading cause of preventable death in trauma in 
both the military and civilian settings worldwide. Medical studies from 
Operation Enduring Freedom (OEF) and Operation Iraqi Freedom (OIF) informed 
change in military prehospital medicine by influencing widespread tourniquet 
distribution and training on their use to stop life-threatening extremity 
hemorrhage. In the military setting, there has been a significant reduction in 
preventable death due to extremity exsanguination since the widespread 
implementation of tourniquets within the Department of Defense. However, 
noncompressible hemorrhage remains a significant cause of mortality, especially 
in the prehospital setting. In select patients, resuscitative endovascular 
balloon occlusion of the aorta (REBOA) is an adjunct that can be utilized to 
slow or stop non-compressible hemorrhage until the patient reaches definitive 
care. However, frontline medical providers face the challenge of reliable, 
accurate blood pressure measurement in REBOA patients. REBOA, used in 
conjunction with a small disposable pressure monitor, can bridge the gap in 
capabilities, creating a more balanced resuscitation and reducing blood product 
requirements with the added benefit of invasive blood pressure monitoring 
capability. The authors of this study propose the sustained use and further 
validation of a small, disposable pressure monitor in REBOA to monitor 
beat-to-beat variation in both hemodynamically stable and unstable patients and 
seek to offer a pathway for use in austere environments. Materials and methods 
Yorkshire swine (n = 4) were selected for partial REBOA (pREBOA) placement and 
compass transducer measurement in conjunction with a vascular experimental 
protocol. Appropriate vascular and arterial line access was obtained, 
hemorrhagic shock was initiated, and REBOA with an in-line Compass™ device (CD) 
pressure transducer (Centurion Medical Products, Williamston, MI) was used to 
occlude the aorta. Mean arterial pressures were measured via the CD, recorded, 
and compared to the control arterial line at hypotensive, normotensive, and 
hypertensive pressures. Results At hypotensive pressures, 30% of the CD readings 
fell within 1 mmHg of control arterial line readings, and 52.3% were within 2 
mmHg. At normotensive pressures, 46% of the CD readings fell within 1 mmHg of 
control arterial line readings, and 64.2% were within 2 mmHg. At hypertensive 
pressures, 60% of the CD readings fell within 1 mmHg of control arterial line 
readings, and 82% were within 2 mmHg. All CD data points at all pressures were 
within 8 mmHg of the control arterial line readings. Conclusions In conclusion, 
the CD is a compact, inexpensive, portable pressure-sensing device that may 
potentially augment the safety and functionality of the REBOA in trauma patients 
both at the point of injury and in the hospital. This novel study conducted on 
four swine subjects demonstrated a remarkable correlation to the traditional 
equipment intensive arterial line setups, and issues of stasis and 
non-pulsatility were easily troubleshot. Future studies should investigate CD 
use in REBOA catheters under different physiological conditions, specifically 
arrhythmias, and in different environments (prehospital, air medical transport, 
and austere locations).

Copyright © 2024, Lussier et al.

DOI: 10.7759/cureus.70789
PMCID: PMC11531354
PMID: 39493181

Conflict of interest statement: Human subjects: All authors have confirmed that 
this study did not involve human participants or tissue. Animal subjects: 
Institutional Animal Care and Use Committee (IACUC): The research protocol was 
approved by the IACUC of the Uniformed Services University of the Health 
Sciences. Ethical approval and Trial Registration Details Per Reviewer Request 
Below: 
--------------------------------------------------------------------------------- 
USUHS / DOD – SPONSORED ANIMAL RESEARCH PROPOSALS MUST USE THIS STANDARDIZED 
FORMAT Reference DOD Directive 3216.1 & USUHS Instruction 3203 
*************************************************************************************Specific 
information requested in the following animal-use protocol template is a result 
of requirements of the Animal Welfare Act regulations (AWAR), the Guide for the 
Care and Use of Laboratory Animals, and other applicable Federal regulations and 
DOD directives. 
************************************************************************************* 
This document is intended to be an aid in the preparation of a USUHS DOD – 
sponsored animal use proposal. The instructions and written explanations 
provided for individual paragraphs (ref. animal-use protocol template in AR 
40-33 / USUHSINST 3203, Appendix C) are coded as hidden text. To see the 
instructions and examples for each section, select the “Show/Hide ¶” button on 
your tool bar. To print the hidden text, select “Print” on the drop down file 
menu. Under the “Options” button, select “Hidden text” under the “Include with 
document” section. Use of a word processor makes completion of this template a 
“fill-in-the-blanks” exercise. Please provide all response entries in the 
following font: Arial, Regular, 12, Black. Please do NOT submit this page of 
instructions with your animal protocol submission. With the exception of title 
headings, each paragraph and subparagraph in the following template must have a 
response. Portions of the template that are not applicable to your particular 
protocol, (i.e., no surgery or no prolonged restraint) should be marked “N/A”. 
There are no space limitations for the responses. Do not delete any sections. 
Pertinent standing operating procedures or similar documents that are readily 
available to your IACUC may be referenced to assist in the description of 
specific procedures. It is critical that only animal studies or procedures 
documented in an IACUC – approved protocol be performed at your facility. 
Additionally, Principal Investigators, or other delegated research personnel, 
should keep accurate experimental records and be able to provide an audit trail 
of animal expenditures and use that correlates to their approved protocol. USUHS 
FORM 3206 ANIMAL STUDY PROPOSAL PROTOCOL COVER SHEET PROTOCOL NUMBER: SUR-19-965 
PROTOCOL TITLE: Partial resuscitative endovascular balloon occlusion of the 
aorta (PREBOA) characterization of targeted distal flow and permissive regional 
hypoperfusion in a porcine model (Sus scrofa domesticus) of hemorrhagic shock 
GRANT TITLE (if different from above): NA USUHS PROJECT NUMBER// DAI GRANT 
NUMBER: Pending FUNDING AGENCY: USU USUHS Form 3206 – Revised February 2018 
Previous versions are obsolete EARLIEST ANTICIPATED FUNDING START DATE: Pending 
PRINCIPAL INVESTIGATOR: Joseph White, MAJ, MC, USA Surgery 301-319-2852 28 Feb 
2017 MAJ Joseph White, MD Department Office telephone Date SCIENTIFIC REVIEW: 
This animal use proposal received an appropriate peer scientific review and is 
consistent with good scientific research practice. CAPT Eric A. Elster 
Department Office telephone Date STATISTICAL REVIEW: A person knowledgeable in 
biostatistics reviewed this proposal to ensure that the number of animals used 
is appropriate to obtain sufficient data and/or is not excessive, and the 
statistical design is appropriate for the intent of the study. Statistics USUS 
301-295-9468 28 Feb 2017 Cara Olsen, MS, DrPH Department Office telephone Date 
ATTENDING VETERINARIAN: In accordance with the Animal Welfare Regulations, the 
Attending Veterinarian was consulted in the planning of procedures and 
manipulations that may cause more than slight or momentary pain or distress, 
even if relieved by anesthetics or analgesics. All signatures are required prior 
to submission to the IACUC Office. LAM 301-295-9492 Anna B. Mullins, DVM, DACLAM 
Department Office telephone Date BIOSAFETY OFFICER: Only required if using any 
infectious pathogens. EHS Peter Bouma Department Office telephone Date USUHS 
Form 3206 – Revised February 2018 Previous versions are obsolete ANIMAL PROTOCOL 
NUMBER: Pending PRINCIPAL INVESTIGATOR Joseph M. White, MD, FACS MAJ, MC, USA 
Assistant Program Director, Vascular Surgery Fellowship Assistant Professor of 
Surgery The Department of Surgery at Uniformed Services University of the Health 
Sciences and Walter Reed National Military Medical Center Office: 301-319-2852 
Email: joseph.m.white70.mil@mail.mil ANIMAL PROTOCOL TITLE: Partial 
resuscitative endovascular balloon occlusion of the aorta (PREBOA) 
characterization of targeted distal flow and permissive regional hypoperfusion 
in a porcine model (Sus scrofa domesticus) of hemorrhagic shock GRANT TITLE (if 
different from above): NA USUHS PROJECT NUMBER// DAI GRANT NUMBER: Pending 
CO-INVESTIGATOR(S): Todd E. Rasmussen, MD FACS Colonel USAF MC Shumacker 
Professor of Surgery Associate Dean for Clinical Research F. Edward Hebert 
School of Medicine - "America's Medical School" Uniformed Services University of 
the Health Sciences 4301 Jones Bridge Road Bethesda, Maryland 20814-4712 Office: 
301-295-3016 Mobile: 210-508-7062 Email: todd.rasmussen@usuhs.edu Paul W. White, 
MD, FACS LTC, MC, USA Program Director, Vascular Surgery Fellowship Associate 
Professor of Surgery, The Department of Surgery at Uniformed Services University 
of the Health Sciences and Walter Reed National Military Medical Center Office: 
301-295-4779 Email: paul.w.white4.mil@mail.mil Thomas A. Davis, PhD Deputy Vice 
Chair of Research Professor USUHS Form 3206 – Revised February 2018 Previous 
versions are obsolete USU Walter Reed Surgery Uniformed Services University of 
the Health Sciences 4301 Jones Bridge Road Bethesda, MD 20814 Office: 
301-295-9825 Mobile: 301-204-5212 Email: thomas.davis@usuhs.edu I. NON-TECHNICAL 
SYNOPSIS: During recent military conflicts, medics and surgeons treat combat 
trauma patients with critical injuries to the chest, abdomen, and pelvis areas 
where it can be nearly impossible to control bleeding to save a service member’s 
life. While the application of tourniquets helps prevent life-threatening blood 
loss from wounds to extremities (arms and legs), nothing exists for critical 
injuries to the chest, abdomen, and pelvis in combat and in emergency care 
environments. A new technology referred to as resuscitative endovascular balloon 
occlusion of the aorta (REBOA) has been used in trauma patients suffering from 
rapid blood loss as a result of injuries to their chest, abdomen, and pelvis. 
This technique involves rapidly placing a flexible catheter into the femoral 
artery in the groin, maneuvering, and placement in the aorta, and then inflation 
of an attached balloon at the tip to stop the uncontrolled bleeding. Not 
surprisingly, total blockage of blood flow to areas to various regions of the 
body for an extensive time period has resulted in some serious follow-on medical 
complications. In this proposal, we will test and evaluate the next generation 
of PREBOA (partial PREBOA) in a well-characterized non-survival swine hemorrhage 
model. We hypothesize that this new technology will permit longer utilization, 
enhance organ oxygenation to maintain tissue viability and increase patient 
survival II. BACKGROUND: II.1. Background: In the current conflicts, many 
wounded service members have survived catastrophic traumatic injuries. They 
would have died from these injuries in previous wars, but improvements in 
battlefield medical care and the use of body armor have increased survival 
rates. Hemorrhage, particularly non-compressible torso hemorrhage (NCTH), has 
been identified as a leading cause of preventable death on the modern 
battlefield.[1,2] Analysis from the recent wars in Iraq and Afghanistan has 
demonstrated that hemorrhage was the underlying physiologic insult in 90% of 
potentially survivable battlefield injuries.[3] The stratification of mortality 
from death on the battlefield from 2001-2011 (Iraq and Afghanistan) demonstrated 
that 87.3% of all injury mortality occurred in the pre-MTF environment.[3] Of 
the pre-MTF deaths, 75.7% (n = 3,040) were classified as nonsurvivable, and 
24.3% (n = 976) were deemed potentially survivable (PS). The injury/physiologic 
focus of PS acute mortality was largely associated with hemorrhage (90.9%). The 
site of lethal hemorrhage was truncal (67.3%), followed by junctional (19.2%) 
and peripheral-extremity (13.5%) hemorrhage. The management of traumatic 
hemorrhage (specifically, NCTH) requires innovative strategies and devices to 
overcome the current trend identified in modern combat. PREBOA seeks to address 
this critical gap and alter casualty mortality rates as a result. Resuscitative 
Endovascular Balloon Occlusion of the Aorta (REBOA) has emerged as a promising 
technique for cases of severe NCTH during trauma. An emerging set of 
pre-clinical and clinical data on the use of REBOA reports highly successful 
outcomes following brief periods of occlusion; however, longer periods of 
occlusion are associated with significantly increased mortality.[4,5] 
Therapeutic strategies that incorporate regulated partial distal aortic flow and 
perfusion are a potential technique to mitigate ongoing distal ischemia and 
subsequent reperfusion injury while potentially avoiding the deleterious USUHS 
Form 3206 – Revised February 2018 Previous versions are obsolete complications 
of distal clot disruption with ongoing hemorrhage and supraphysiologic central 
and cerebral pressures.[6] In order to allow distal aortic flow and perfusion at 
a controlled and regulated level, REBOA distal flow characteristics require 
additional pre-clinical testing and evaluation. The PREBOA-PRO Catheter utilizes 
the same basic technological characteristics as the existing ER-REBOA Catheter – 
complete large vessel occlusion and blood pressure monitoring – with minor 
modifications to the balloon design to help facilitate a smoother transition 
between full occlusion and no occlusion. The PREBOA-PRO Catheter employs a 
composite balloon design that arranges a non-compliant partner or “spine” 
balloon in parallel with a compliant occlusion balloon. When the balloon system 
is fully inflated, complete occlusion is achieved. During balloon deflation, 
bypass channels initially open around the partner balloon, allowing a limited 
amount of blood to flow past the balloon, while maintaining balloon wall 
apposition Figure 1). This permits modulation of blood pressure gradient across 
the balloon during inflation/deflation cycles. Partial REBOA is a a technique, 
which shows great promise to reduce morbidities associated with survival from 
REBOA and extend the amount of time in which REBOA can be performed. REBOA is a 
resuscitative adjunct that augments central and cerebral perfusion while 
mitigating lethal hemorrhage secondary to NCTH. Next generation Prytime Medical 
Devices Inc. partial REBOA (PREBOA-PRO) catheter is currently not FDA-approved 
for use. Standard REBOA catheter systems are currently in use in military Role 
I, II, and III facilities and Medical Treatment Facilities. Forward elements 
such as GHOST-T (Golden Hour Offset Surgical Treatment-Teams) and SOST (Special 
Operations Surgical Teams) have incorporated and implemented REBOA technology on 
the forward edge of the battlefield. Civilian level 1 trauma centers currently 
use REBOA catheter systems. Clinical use typically employs “all-or-nothing” 
REBOA, meaning that the balloon is fully inflated or completely deflated. PREBOA 
allows for distal aortic flow, potentially expanding the resuscitation envelope. 
This would represent lengthening the “golden hour” and augmenting austere or 
prolonged field care. Permissive Regional Hypoperfusion (PRH) following complete 
aortic occlusion incorporates regulated partial distal aortic flow and perfusion 
with subsequent mitigation of distal ischemia and reperfusion injury. This 
concept potentially avoids the deleterious complications of distal clot 
disruption with ongoing hemorrhage and supraphysiologic central and cerebral 
pressures. Building upon the knowledge acquired during previous REBOA testing: 
REBOA Distal Flow Dynamics and Targeted Distal Flow Characterization (which 
characterizes the flow-volume relationship and TDF fidelity), this project 
attempts to identify the critical flow threshold at which Permissive Regional 
Hypoperfusion (PRH) allows for optimal metabolic and physiologic results. The 
overarching goal is to decrease morbidity and mortality in the out-of-hospital 
(prehospital, en-route and far forward medicine) environment scenarios using a 
partial occlusive endovascular device (pREBOA) to lessen hypotension and 
ischemia-reperfusion injury while augmenting pulmonary and cerebral perfusion. 
In this study, we will compare several state-of the-art intravascular occlusion 
devices in a swine model of lethal non-compressible torso hemorrhage (NCTH). 
Figure 1: The pREBOA-PROTM Catheter USUHS Form 3206 – Revised February 2018 
Previous versions are obsolete II.2. Literature Search for Duplication: II.2.1. 
Literature Source(s) Searched: PubMed, DTIC, and NIH RePORT were searched to 
avoid unnecessary duplication of research. II.2.2. Date of Search: 8 January 
2018 II.2.3. Period of Search: 1990 to present II.2.4. Key Words and Search 
Strategy: Separate search terms: PREBOA (partial resuscitative endovascular 
balloon occlusion of the aorta) in a large animal model (9) REBOA (resuscitative 
endovascular balloon occlusion of the aorta) in a large animal model (14) 
Combined search terms: PREBOA (partial resuscitative endovascular balloon 
occlusion of the aorta) in a large animal model AND Sus scrofa domesticus (7) 
REBOA (resuscitative endovascular balloon occlusion of the aorta) in a large 
animal model AND Sus scrofa domesticus (9) PREBOA (partial resuscitative 
endovascular balloon occlusion of the aorta) in a large animal model AND 
Hemorrhagic shock (7) REBOA (resuscitative endovascular balloon occlusion of the 
aorta) in a large animal model AND Hemorrhagic shock (9) (Please see appendix A) 
II.2.5. Results of Search: Summary: No studies were identified in the literature 
that would appear to duplicate the proposed large-animal research project. The 
PREBOA-PRO prototype to be evaluated is novel, and no duplicative in vivo 
studies were identified. Please see Appendix A for Search Results. III. 
OBJECTIVE\HYPOTHESIS: The objectives of this study are two-fold (1) to 
characterize distal aortic flow following PREBOA using the ER-REBOA, and 
PREBOA-PRO catheters in an established, translational, swine model of lethal 
NCTH and (2) to identify the critical threshold at which Permissive Regional 
Hypoperfusion (PRH) allows for reduced perfusion pressure promoting clot 
stabilization (avoidance of hemorrhage), mitigates tissue ischemia and 
reperfusion injury, and dampens supraphysiologic central and cerebral pressures. 
We hypothesis the PREBOA-PRO catheters will demonstrate superior Targeted Distal 
Flow (TDF) fidelity compared to the ER-REBOA and that a TDF of 150mL/min will 
demonstrate. USUHS Form 3206 – Revised February 2018 Previous versions are 
obsolete clot stabilization (avoid free intraperitoneal hemorrhage), mitigate 
distal ischemia and reperfusion injury and result in a reduction of 
supraphysiologic central and cerebral pressures thereby demonstrating superior 
Permissive Regional Hypoperfusion (PRH). IV. MILITARY RELEVANCE: Eastridge and 
colleagues reported that hemorrhage is the leading cause of preventable death on 
the modern battlefield. Between October 2001 and June 2011, 4,596 battlefield 
fatalities were reviewed and analyzed during the wars in Iraq and Afghanistan. 
The stratification of mortality demonstrated that 87.3% of all injury mortality 
occurred in the pre-MTF (Medical Treatment Facility) environment. Of the pre-MTF 
deaths, 75.7% (n = 3,040) were classified as nonsurvivable, and 24.3% (n = 976) 
were deemed potentially survivable (PS). The injury/physiologic focus of PS 
acute mortality was largely associated with hemorrhage (90.9%). The site of 
lethal hemorrhage was truncal (67.3%), followed by junctional (19.2%) and 
peripheral-extremity (13.5%) hemorrhage.[3] The management of hemorrhage is 
critical to improving combat causality care (CCC) in the military. Resuscitative 
Endovascular Balloon Occlusion of the Aorta (REBOA) has emerged as a promising 
technique for cases of severe NCTH during trauma. Prompt control of bleeding and 
resuscitation in the field can reduce mortality by as much as 20%. Importantly, 
hemorrhage is a major mechanism of death in potentially survivable combat 
injuries, underscoring the necessity for initiatives to mitigate bleeding and to 
develop new solutions to provide for prolonged Damage Control Resuscitation 
(pDCR), particularly in the prehospital-en route and prolonged field care (PFC) 
austere environment. Treatments initiated within the “Golden Hour”- 60 minute