Catherine Go1, Youngjae J Chun2, Jenna Kuhn3, Yanfei Chen2, Sung Kwon Cho4, William C Clark4, Bryan W Tillman5. 1. Division of Vascular Surgery, University of Pittsburgh Medical Center, Pittsburgh, Pa; McGowan Institute for Regenerative Medicine, University of Pittsburgh, Pittsburgh, Pa. 2. Industrial Engineering, Swanson School of Engineering, University of Pittsburgh, Pittsburgh, Pa. 3. McGowan Institute for Regenerative Medicine, University of Pittsburgh, Pittsburgh, Pa. 4. Mechanical Engineering & Materials Science, Swanson School of Engineering, University of Pittsburgh, Pittsburgh, Pa. 5. Division of Vascular Surgery, University of Pittsburgh Medical Center, Pittsburgh, Pa; McGowan Institute for Regenerative Medicine, University of Pittsburgh, Pittsburgh, Pa; Department of Surgery, University of Pittsburgh Medical Center, Pittsburgh, Pa. Electronic address: tillmanbw@upmc.edu.
Abstract
OBJECTIVE: Early hemorrhage control before the operating room is essential to reduce the significant mortality associated with traumatic injuries of the vena cava. Conventional approaches present logistical challenges on the battlefield or in the trauma bay. A retrievable stent graft would allow rapid hemorrhage control in the preoperative setting when endovascular expertise is not immediately available and without committing a patient to the limitations of current permanent stents. This study details a refined retrievable Rescue stent for percutaneous delivery that was examined in a porcine survival model of penetrating caval hemorrhage. METHODS: A retrievable caval stent was reduced in delivery profile to a 9F sheath using finite element analysis. The final stent was constructed with a "petal and stem" design using nitinol wire followed by covering with polytetrafluoroethylene. Seven Yorkshire pigs (79-86 kg) underwent 22F injury of the infrarenal vena cava with intentional class II hemorrhage (1200 mL). Percutaneous deployment of the Rescue stent was used to temporize hemorrhage for 60 minutes, followed by resuscitation with cell saver blood and permanent caval repair. Hemorrhage control was documented with photography and angiography. Vital signs were recorded and laboratory values were measured out to 48 hours postoperatively. Data were examined with a repeated-measures analysis of variance. RESULTS: The profile of the caval Rescue stent was successfully reduced from 16F to 9F while remaining within fracture and shape memory limits for nitinol. In addition, both rapid deployment and recapture were preserved. Following intentional hemorrhage after caval injury, animals revealed a significant drop in mean arterial pressure (average, 30 mm Hg), acidosis, and elevated lactate level compared with before injury. Compared with uncontrolled hemorrhage, which resulted in death in <9 minutes, the Rescue stent achieved hemorrhage control in <1 minute after venous access in all seven animals. All animals were successfully recovered after permanent repair. There was no significant change in levels of transaminases, bilirubin, creatinine, or hemoglobin at 48 hours compared with preinjury baseline. CONCLUSIONS: A retrievable Rescue stent achieved rapid percutaneous hemorrhage control after a significant traumatic injury of the vena cava and allowed successful recovery of all injured animals. Further development of this approach may have utility in preoperative damage control of caval injuries.
OBJECTIVE: Early hemorrhage control before the operating room is essential to reduce the significant mortality associated with traumatic injuries of the vena cava. Conventional approaches present logistical challenges on the battlefield or in the trauma bay. A retrievable stent graft would allow rapid hemorrhage control in the preoperative setting when endovascular expertise is not immediately available and without committing a patient to the limitations of current permanent stents. This study details a refined retrievable Rescue stent for percutaneous delivery that was examined in a porcine survival model of penetrating caval hemorrhage. METHODS: A retrievable caval stent was reduced in delivery profile to a 9F sheath using finite element analysis. The final stent was constructed with a "petal and stem" design using nitinol wire followed by covering with polytetrafluoroethylene. Seven Yorkshire pigs (79-86 kg) underwent 22F injury of the infrarenal vena cava with intentional class II hemorrhage (1200 mL). Percutaneous deployment of the Rescue stent was used to temporize hemorrhage for 60 minutes, followed by resuscitation with cell saver blood and permanent caval repair. Hemorrhage control was documented with photography and angiography. Vital signs were recorded and laboratory values were measured out to 48 hours postoperatively. Data were examined with a repeated-measures analysis of variance. RESULTS: The profile of the caval Rescue stent was successfully reduced from 16F to 9F while remaining within fracture and shape memory limits for nitinol. In addition, both rapid deployment and recapture were preserved. Following intentional hemorrhage after caval injury, animals revealed a significant drop in mean arterial pressure (average, 30 mm Hg), acidosis, and elevated lactate level compared with before injury. Compared with uncontrolled hemorrhage, which resulted in death in <9 minutes, the Rescue stent achieved hemorrhage control in <1 minute after venous access in all seven animals. All animals were successfully recovered after permanent repair. There was no significant change in levels of transaminases, bilirubin, creatinine, or hemoglobin at 48 hours compared with preinjury baseline. CONCLUSIONS: A retrievable Rescue stent achieved rapid percutaneous hemorrhage control after a significant traumatic injury of the vena cava and allowed successful recovery of all injured animals. Further development of this approach may have utility in preoperative damage control of caval injuries.
Authors: Joseph J DuBose; Thomas M Scalea; Megan Brenner; Dimitra Skiada; Kenji Inaba; Jeremy Cannon; Laura Moore; John Holcomb; David Turay; Cassra N Arbabi; Andrew Kirkpatrick; James Xiao; David Skarupa; Nathaniel Poulin Journal: J Trauma Acute Care Surg Date: 2016-09 Impact factor: 3.313
Authors: James D Maciel; David Plurad; Edward Gifford; Christian deVirgilio; Matt Koopmann; Angela Neville; Brant Putnam; Dennis Y Kim Journal: Am Surg Date: 2015-10 Impact factor: 0.688
Authors: Cassandra L Reynolds; Adam C Celio; Lindsay C Bridges; Catalina Mosquera; Brian OʼConnell; Michael R Bard; Connie M DeLaʼo; Eric A Toschlog Journal: J Trauma Acute Care Surg Date: 2017-12 Impact factor: 3.313
Authors: Sergio Huerta; Trung D Bui; Tien H Nguyen; Faried N Banimahd; Diana Porral; Matthew O Dolich Journal: Am Surg Date: 2006-04 Impact factor: 0.688
Authors: Youngjae Chun; Sung Kwon Cho; William C Clark; William R Wagner; Xinzhu Gu; Amit D Tevar; Ryan M McEnaney; Bryan W Tillman Journal: J Trauma Acute Care Surg Date: 2017-08 Impact factor: 3.313
Authors: Catherine Go; Moataz Elsisy; Brian Frenz; J B Moses; Amit D Tevar; Anthony J Demetris; Youngjae Chun; Bryan W Tillman Journal: Surgery Date: 2021-11-25 Impact factor: 3.982