The purpose of this study is to evaluate the procedural and clinical benefits of patient specific pre-procedure rehearsal for operators with various experience levels as a tool for optimizing Endovascular Aneurysm Repair (EVAR) procedures.
Study Type
OBSERVATIONAL
Enrollment
150
Baptist Cardiac and Vascular Institute
Miami, Florida, United States
RECRUITINGUniversity of South Florida, Tampa General Hospital
Tampa, Florida, United States
RECRUITINGHoly Name Medical Center
Teaneck, New Jersey, United States
Overall Fluoro time
Time frame: Within 4 hr. after EVAR procedure starts
Subjective operator perceived effectiveness of prior procedure rehearsal
Time frame: Within 4 hr. after EVAR procedure starts
Intraprocedural safety measurements
1. Overall contrast use (volume) 2. Skin entry radiation dose 3. Overall procedure time (from gaining bilateral access until the satisfactory completion of endograft deployment, excluding all adjunctive procedures such as hypogastric embolization, Iliac Percutaneous Transluminal Angioplasty (PTA)/Stenting, sheath removal and hemostasis time) 4. Procedural blood loss - number of transfused units 5. Arterial injury (dissection, perforation, rupture, surgical conversion, embolization, none)
Time frame: Within 4 hr. after EVAR procedure starts
Change in procedure plan
Comparison of treatment plans based on Customary (normal institutional) technique, following 3D reconstruction, and after simulation procedures.
Time frame: Within 4 hr. after EVAR procedure rehearsal starts
Adjunctive device utilization
Number and type of used wires, catheters, stent grafts, additional stent graft components and balloons
Time frame: Within 4 hr. after EVAR procedure ends
Gate cannulation time
Time to cannulate the contralateral gate with a wire.
Time frame: Within 3 hr. after EVAR procedure starts
Similarity of simulation to actual case
1. Anatomy 2. Anticipated devices (sizing, tools) 3. Fluoroscopic Angulations 4. Case complexity
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University Hospital Case Medical Center
Cleveland, Ohio, United States
RECRUITINGRiverside Methodist Hospital
Columbus, Ohio, United States
RECRUITINGC.H.U De Nancy
Nancy, France
RECRUITINGPoliclinico S. Orsola-Malpighi
Bologna, Italy
RECRUITINGTime frame: Within 3 hr. after EVAR procedure ends
General satisfaction- Subjective experience of simulation experience
1. Overall ease of use 2. Controls 3. Imaging 4. Device exchanges 5. Device performance
Time frame: Within 4 hr. after EVAR procedure ends
Cost analysis
Time frame: Within the first 30 days after the EVAR procedure
Technical/Clinical success rate
Successful endograft deployment and absence of type 1 or 3 endoleak
Time frame: Within the first 30 days after the EVAR procedure
Time of simulator rehearsal
Time frame: Within 3 hr. after EVAR procedure rehearsal ends
Time in ICU
Time frame: within 30 days after the EVAR procedure
Overall Length of Stay
Time frame: Within 30 days after the EVAR procedure