Resuscitative Endovascular Occlusion of the Aorta (REBOA): Challenges of Launching a City Wide Program

Transcription

1 Resuscitative Endovascular Occlusion of the Aorta (REBOA): Challenges of Launching a City Wide Program Gerald Fortuna, MD Col, USAF, MC, SFS Director, C-STARS St Louis Assistant Professor Sections of Vascular and Trauma/Critical Care

2 Disclosures The views and opinions shown here are those of the author and do not respresent those of the US Government or the US Air Force. Speakers Bureau for Prytime

3 REBOA Percutaneous transfemoral (i.e. endovascular)

4 Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) Not for control of ruptured aneurysms but for hemorrhagic shock from trauma/injury Zone I Zone III

5 Clinical Use of REBOA Baltimore Shock Trauma Center 2013

6 REBOA 2016: The ER-REBOA Catheter FDA-approved 7 French Arterial Pressure Monitoring Prophylactic No Guide wire No Fluoroscopy*

7 REBOA First step was to define the need Gain institutional by in to purchase the device Get inter-departmental by in from multiple Departments and Sections Develop an agreed upon Protocol Train appropriate personnel and ancillary staff Build the infrastructure Obtain and define credentialing criteria Ensure a PI and data collection process for Quality Control

8 Clinical Need CLINICAL NEED Initially defined out of military needs to find better ways to stop non compressible truncal hemorrhage Eastridge et al 20% battlefield deaths are potentially preventable No one should bleed to death. Yet hemorrhage is the leading cause of potentially survivable death in civilian and military trauma Truncal hemorrhage is of particular interest, because there are limited clinical options to temporarily occlude large vessels during truncal hemorrhage. 70% of deaths in the military setting are caused by exsanguination from truncal injuries, of which 90% occur before hospital admission. 6 The civilian experience is similar

9 ER-REBOA TM Catheter Future of Care for Temporary Occlusion of Large Vessels Copyright 2017 Prytime Medical Devices, Inc. ER-REBOA is a registered trademark. ER-REBOA COST EFFECTIVENESS SAVINGS WORKSHEET Category Actual Typical Calculations Backup / Assumptions*** A. Catheter Costs B. Blood Products C. Operating Room Time for Access Site Repair D. Femoral Access Site Major Complications E. Training time for surgeons and staff F. Reduced patient morbidity Key Assumption: Stopping bleeding sooner is better. $ 450 Cost of off label / alternate catheter Assume 8 REBOA cases per month = 96 per year $ 45 + Cost of current guidewire Assume improved speed will reduce blood use, incidence of MT, and reduce $ 25 + Cost of A-Line patient morbidity and mortality. 8,24 $ 25 + Sutures for access site repair Assume reduced catheter size will reduce access site repair entirely compared $ Closure devices and/or vascular patch for access site to larger catheters, thereby reduce morbidity at access site 19 $ 670 = SAVINGS per procedure Fewer blood products used: Type/amount of blood products used varies clinically, assume $250 per unit 20. $ 250 Whole blood, PRBCs, FFP, Cryo precip, Factor VII, TXA, etc Assume ave 1 less unit of blood product per patient. ref $ Less blood required for Massive Transfusion (MT): $ 510 = SAVINGS per procedure $ 400 Reduction in operating room time $ Reduced off hour vascular surgery consults $ 580 = SAVINGS per procedure Reduction in major access complications X Cost per Complication / total cases $ 1,530 = SAVINGS per procedure Reduction in training hours X Cost per Hour / total cases $ 10 = SAVINGS per procedure Reduction in massive transfusion rate means less TRALI Additionally, assume 1 less MT every 48 REBOA procedures (6 months). Extreme MT can require 50+ units units*$250*2/98 REBOA per yr = $260 saved per procedure on MT blood. Assume Fully loaded cost per minute of OR time = $ Assume average operative arteriotomy/repair = 20 min 20 min X $20/hr = $400 After hours Vascular * min 1 60% of REBOA cases occuring during peak trauma times (off hours) = $300 *.6 = $180 REBOA-ER designed for no need for access site closure. Access site closure major complications range from 6-10% 21. Assume 96 REBOA cases per year (8 per mo), avoid 6% x 96 = 5.76 infections or other complication x 3 ICU $8500 per day 23 = $25,500 *5.76 / 96 = $1530 Assume REBOA with old technology requires more Trauma team training. Assume 1 hr of training reduces x 10 staff x $100/hr div by 98 cases per year = $10.20 Avoiding even one case of TRALI saves entire cost of new catheters 24. Calculate as % of total REBOA cases. Assume 2 MT cases per year avoided. 1 in 4 MT cases have additional major complications = 1 less TRALI per every 2 years. = $50,000 / 2 / 98 cases = $255 per case $ 255 = SAVINGS per procedure Savings/Patient $ 3,555 = Cumulative SAVINGS per procedure A + B + C + D + E + F $ 1,995 Cost per new catheter $ 1,560 TOTAL savings using new catheter per procedure Patients/Year X 98 Total number of REBOA patients per year Annual Savings $ 152,880 = TOTAL ANNUAL SAVINGS (SAVINGS/PATIENT) x (PATIENTS/YEAR) ***Note: Assumptions are based on available data for similar devices in the published literature. These estimates may be used to establish a baseline overall estimate of potential cost savings. We recommend you use your best judgement, and take into consideration your own institution s history, demographics and overall experience with existing treatment modalities in order to calculate specific savings for your institution.

10 Technique for REBOA

11 CMRP Continuing Education/Cert Providers ATLS Nurses ATCN Technicians TCCC RTs N/A C-STARS St Louis Cadre Roles CMRP (AFSC Skill Training) 15 cadre requirements (prep/plan/instruct) Didactic Simulation Clinical Rotation preceptor support Cadaver lab 19 classes per year, class length=12 days 17 AFSCs/specialties 18 student seats/class 342 Student seats annually Clinical Rotation Requirements Providers (CMRP cadre) -maintain skill proficiency/solidify + maintain preceptor role Nurses (CMRP cadre)-maintain skill proficiency/solidify + maintain preceptor role Techs (CMRP Cadre) -maintain skill proficiency/solidify + maintain preceptor role Respiratory Therapists (CMRP) -maintain skill proficiency/solidify + maintain preceptor role Manning Mil Auth 15 Mil Assigned 15 (100%) Mil Deployed 0 (2 sch) GS Auth/Assigned 1 ANG Full-Time 2* ANG Traditional (4*) Civ/Contr Auth/Assigned 2 (100%) Overall Auth 20 Overall Assign 20 (100%) *state asset Administration Support (1 FTE) UDM, Logistics, TAAs, Hospital Interaction, Budget, Travel, Scheduling, Planning Simulation Support (2 FTEs) Sim Preparation, Planning, Execution, Repair, Storage, Education 1

12 Clinical Settings BARNES-JEWISH HOSPITAL/ WASHINGTON UNIVERSITY Level I Trauma Center annual trauma patients Cadre (surgical, ER MD) maintain presence/credentials ST. LOUIS UNIVERSITY HOSPITAL Level I Trauma Center annual trauma patients 6 trauma activations/day All rotators participate in shifts: ER, ICUs, OR (surgery/anesthesia) All cadre maintain presence/credentials in respective areas CARDINAL GLENNON PEDIATRIC HOSPITAL Level I Pediatric Trauma Center Annual ER visits, 500 trauma activations Rotating RNs > ER or PICU Rotating RTs > PICU MERCY HOSPITAL Level I Trauma Center 6 trauma/treatment bays Only certified local burn center Rotating RNs, Medics and RTs > Burn Unit Rotating RNs and Medics > ER 1

13 Primary Clinical Summaries ST LOUIS UNIVERSITY HOSPITAL Annual Trauma/ACS surgeries: 6 Trauma activations/day Daily Trauma Admissions: 5 LOS: 5.9 days Daily Trauma Census: 28 OR Minutes: UTA 3 Trauma bays 65 ICU beds 11 trauma ICU, 13 neuro ICU WASHINGTON UNIVERSITY/BJC Annual Trauma/ACS surgeries: Trauma activations/day Daily Trauma Admissions: 11 Trauma visits annually: Daily Hospital Census: 980 Daily Trauma Census: 60 Avg LOS: 5 days OR Minutes: TNTC 12 Trauma resuscitation bays 1300 Inpatient beds 132 ICU beds-36 SICU, 34 trauma step-down 2 HBO chamber

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15 REBOA In-Services BJH: 24 SLU: 21 Combined events: 2 Covered Trauma Staff, General Surgery Staff, Residents, ED Staff, Anesthesia Staff, IR staff, OR nurses, ED nurses, ICU nurses This is not a one time event! Commitment to continually train as turn over is constant

16 REBOA Training All staff were required to go through a nationally recognized course for certification or a BEST like course put on by already trained SME s at each site Training consisted of 4 hours of hands on training and didactics No measure of proficiency, no tests, no validation Ancillary staff and residents were trained to familiarization only

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21 18 gauge (not 20)= compatible with 7Fr Sheath Guidew

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27 Experience 19 REBOAs at Wash U 14 REBOAs at SLU 14/33 Survival rate (43%) 3 access site complications (9%) 6 cutdowns (18%) 16 placed in patients with cardiac arrest (48%) 5 placed in OR (15%) Early lessons learned: Steep learning curve Balloon times Participating in the AAST sponsored AORTIC Registry PI every insertion

28 Future Considerations Guidelines from national bodies still pending Need to expand training to include more specific US guided access procedures and mandatory demonstration of open exposure technique Access is consistently the rate limiting step Currency training to demonstrate continued proficiency in a low volume high acuity procedure Re-hack should be annual Resource intensive effort Sheath ownership and management is critical Continue to refine appropriate patient selection for each institution Participation in some sort of registry should be mandatory! How to tackle pre-hospital implementation