Georgia Society of the American College of Surgeons, Day of Trauma Penetrating right thoracoabdominal injuries can be managed non-operatively without a higher risk of complications Hello, my name is Caitlin Fitzgerald and I’m currently one of the 3rd year surgical residents at Emory University and today I’m going to be speaking with you about one of our clinical projects focusing on the non-operative management of penetrating right thoracoabdominal injuries. Caitlin A. Fitzgerald, MD, Rondi B. Gelbard, MD, Bryan C. Morse, MD, Jonathan Nguyen, DO, Anuradha Subramanian, MD, Christopher J. Dente, MD, Peter M. Rhee, MD Georgia Society of the American College of Surgeons, Day of Trauma August 18, 2017

Background Approach to hemodynamically normal patient with penetrating right thoracoabdominal (RTA) injury is unclear Diaphragmatic injuries occur in up to 30% of patients Failure to repair diaphragm injury can result in herniation of organs, organ necrosis Complications including bilothorax or biliopleural fistula can occur Currently the approach to a hemodynamically unstable patient with penetrating RTA trauma is clear and surgery is the standard of care, however, the approach to a hemodynamically stable patient with the same injury complex is not as clear. As we know, the diaphragm sits right in the middle of the thoracoabdomen and can be injured in up to 30% of patients with penetrating RTA trauma. Failure to repair diaphragm injuries can result in herniation of intraabdominal organs into the chest which can lead to organ strangulation and even necrosis. Furthermore, if a patient is unlucky enough to have both a diaphragm injury and a liver injury, complications such as bilothoraces and biliopleural fistula can occur. Parriera et al. Clinics 2008;63:695-700. Feliciano et al. J Trauma 1988;28:1135-1143.

Historical Perspective Series of 21 patients with penetrating RTA trauma, associated hepatic injuries1 Managed non-operatively, no complications noted during recovery Prospective study examining non-operative management of penetrating RTA trauma2 Nonoperative management is safe with a low incidence of minor complications Series of 34 patients who underwent diagnostic laparoscopy3 Identified 7 diaphragm injuries that may have otherwise been missed Patients should undergo laparoscopy at time of presentation When we look back at some of the historical literature that has examined this problem, we also see a mixed picture. Multiple series in the 80’s and 90’s concluded that non-operative management of penetrating RTA trauma is safe and is not associated with a significant number of complications. However, more recently in the early 2000s a study was published suggesting that patients with penetrating RTA trauma should undergo diagnostic laparoscopy in order to prevent missing a diaphragm injury. Demetriades et al. Br J Surg 1986;73:736. Renz, Feliciano. J Trauma 1994;37:737-744. Friese et al. J Trauma 2005;58:789-792.

Should right-sided diaphragm injuries routinely be repaired? Study objectives Is non-operative management of patients with penetrating right-sided diaphragm injury with or without concomitant liver and lung injury safe? Does non-operative management of a diaphragm injury lead to an increased risk of biliary complications? Should right-sided diaphragm injuries routinely be repaired? Given this unclear historical perspective, we designed this study with 3 main objectives: The first objective was to determine whether or not non-operative management of patients with penetrating right sided diaphragm injuries both with and without liver and lung injuries is safe. The second objective is to determine if non-operative management of diaphragm injuries leads to increased risk of complications involving the biliary system. And finally, our last objective was to determine whether right sided diaphragm injuries should be routinely repaired.

Methods Retrospective chart review of all penetrating RTA injuries at a Level 1 trauma center between 2010 and 2016 Primary outcome: successful non-operative management of penetrating RTA injuries Secondary outcomes: mortality, ICU and hospital LOS, infectious complications, biliary complications, unplanned return to the OR This was a retrospective chart review of all patients presenting to our level 1 trauma center with penetrating RTA injuries between 2010 and 2016. The primary outcome we studied was successful non-operative management of penetrating RTA injuries Our secondary outcomes included things like mortality, length of stay data and various complications.

Diaphragm Not Repaired Results Open repair 74 Diaphragm Repair 76 Laparoscopic repair 2 Total patients 126 Open without repair 14 Overall, a total of 126 patients met inclusion criteria for this study. Of these 126 patients, we broke the groups down into those patients who underwent diaphragm repair (76 patients in total) and those who did not undergo diaphragm repair (50 patients total). Of the group that underwent diaphragm repair, the vast majority underwent open repair and of the group who did not have their diaphragms repaired, 14 patients were taken to the OR for other injuries and 36 weren’t taken to the OR at all. Diaphragm Not Repaired 50 Non-operative 36

Results - Demographics Gender Male 96.8% (122/126) Female 3.2% (4/126) Age 30.4 ± 11.8 GCS 15 ISS 25.0 ± 9.8 Initial lab values SBP 117.9 ± 26.0 HR 76.1 ± 43.4 Base deficit -4.9 ± 5.7 Disposition OR 71.4% (90/126) ICU 27.0% (34/126) Floor 1.6% (2/126) Length of stay (days) Hospital 19.8 ± 19.6 9.3 ± 13.1 Ventilator 5.7 ± 10.5 Mortality 7.9% (10/126) When we looked at the group as a whole, we found that the vast majority at about 97% were males and the average age was 30 years old. Other demographic values including GCS, ISS, and initial lab values are listed there. When we looked at overall disposition from the trauma bay, 90 patients or just over 70% were taken straight to the OR with the other 30% largely going to the ICU. And finally, when we looked at mortality, we found 10 deaths out of 126 patients or an overall mortality of 8% *GCS: Glasgow coma scale, ISS: injury severity score, SBP: systolic blood pressure, HR: heart rate *OR: operating room, ICU: intensive care unit

Results - demographics Diaphragm repair vs. no repair (76) No Repair (50) p-value Age 29.7 ± 11.8 31.5 ± 11.9 0.4 GCS 15 ISS 26.0 ± 9.4 23.2 ± 10.4 0.2 Initial Lab Values SBP 115.1 ± 26.5 122.2 ± 24.9 0.1 HR 80.8 ± 45.8 68.9 ± 38.8 Base deficit -5.5 ± 5.8 -3.9 ± 5.5 Mortality 5 (6.8%) 2 (4.1%) 0.5 Next, we compared the patients who had their diaphragms repaired versus those who did not. When looking at multiple demographics including age, GCS, ISS, and initial lab values, both groups were pretty similar and nothing was statistically significant between the two. We then looked at mortality and found that it was not different between the group who underwent diaphragm repair and the one who did not. and just as a side note, these numbers are excluding 2 patients in the repair group and 1 patient in the non-repair group who had overwhelming hemorrhage at the time of initial surgery, when we exclude these folks, mortality was not found to be different between the two groups (as an aside, when patients with overwhelming hemorrhage were included, mortality was also not statistically different). *GCS: Glasgow coma scale, ISS: injury severity score, SBP: systolic blood pressure, HR: heart rate

Results – Length of stay Diaphragm repair vs. no repair Length of stay (days) Laparoscopic Repair (2) Open Repair (74) No Repair (50) p-value Hospital 8.5 ± 2.1 23.7 ± 20.9 14.6 ± 16.6 0.03 ICU 6.0 ± 1.4 12.1 ± 15.2 5.2 ± 8.1 0.01 Ventilator 2.5 ± 2.1 8.3 ± 12.4 2.0 ± 5.2 0.004 When we looked at length of stay data we separated the group that underwent diaphragm repair into the patients who underwent laparoscopic repair versus open repair versus the group who did not have their diaphragms repaired. Overall, not surprisingly, we found that the group who underwent open diaphragm repair had a longer hospital LOS, ICU LOS, and spent more time on the ventilator. *ICU: intensive care unit

Results – mechanism of injury, cause of death diaphragm repair vs Results – mechanism of injury, cause of death diaphragm repair vs. no repair In a similar fashion to the entire group, we looked at the mechanism of injury across both groups and found that the vast majority of patients in both the repair and non-repair groups were injured as a result of a GSW. Looking at cause of death, in the diaphragm repair group, 4/7 deaths were a result of sepsis of MSOF with the remaining 3 as a result of bleeding whereas in the no repair group, 2 deaths were 2/2 bleeding and 1 death was from overwhelming respiratory failure.

Results – Concomitant injuries Diaphragm repair vs. no repair p-value Liver 72 (94.7%) 50 (100%) 0.1 Lung 39 (51.3%) 47 (94.0%) <0.001 Liver and lung 38 (50.0%) We then looked at who had liver injuries, lung injuries, or the combination of both and found that while there were no differences in the incidence of liver injuries between the two groups, both lung injuries and the combination of liver and lung injuries were more common in the group who did not undergo diaphragm repair.

Results – grade of liver injury diaphragm repair vs. no repair (72) No Repair (50) p-value 1 4 (5.6%) 9 (18.0%) 0.03 II 13 (18.1%) 7 (14.0%) 0.6 III 21 (29.2%) 19 (38.0%) 0.3 IV 16 (22.2%) 10 (20.0%) 0.8 V 6 (8.3%) 2 (4.0%) Not commented 12 (16.7%) 3 (6.0%) - Next we took a deeper look at the grades of liver injuries within each group. Overall, we found that while the group that did not undergo diaphragm repair had a higher incidence of grade I liver injuries, all other grades were statistically similar between groups.

Results - Complications Diaphragm repair vs. no repair p-value Infectious Complication Sepsis 8 (10.5%) 1 (2.0%) 0.07 Superficial surgical site infection 3 (4.0%) 2 (4.0%) 0.9 Deep surgical site infection 6 (7.9%) 0.2 Organ space infection 16 (21.1%) 7 (14.0%) 0.3 Empyema 3 (3.9%) 0.5 Biloma 20 (26.3%) 4 (8.0%) 0.01 Bilothorax 5 (6.6%) 6 (12.0%) Biliopleural fistula 1 (1.3%) 0.06 We then looked at complications. The first thing we found was that there were no differences in the incidence of sepsis or surgical site infections including empyemas between both groups. When we delved into sepsis a little deeper we found that out of the 8 patients in the repair group, all were repaired via an open method and 4 had bowel injuries at the time of presentation. Furthermore, the 1 case of sepsis in the no repair group also had a bowel injury at the time of presentation. When we looked at complications as a result of bile leaks we found that the group who underwent diaphragm repair had a higher incidence of bilomas (all in open repairs), however, there were no differences in bilothoraces or biliopleural fistula. And finally, although this is not included on the slide, we had no cases of either early or delayed diaphragmatic hernias in either group. The 8 cases were made up of 1 line infection, 1 necrotic liver, 3 intra-abdominal abscesses, 1 necrotic bowel, 1 bowel leak resulting in an ECF, and 1 respiratory source

Results – Delayed procedures diaphragm repair vs. no repair p-value VATS 2 (2.6%) 3 (6.0%) 0.3 Hospital Day 12.5 ± 6.4 6.7 ± 3.2 Thoracotomy 4 (5.3%) 4 (8.0%) 0.5 17.3 ± 7.1 8.3 ± 2.2 0.05 When we looked at delayed procedures specifically focusing on delayed thoracic procedures, we found no statistically significant differences in the number of patients who required VATS or thoracotomies. Interestingly, when we looked at what hospital day patients were undergoing their procedures, we found that patients who did not undergo diaphragm repair were being taken to the OR around 9 days earlier for delayed thoracotomies versus the group that underwent diaphragm repair initially. Taking this data a step further, we looked at the reasons behind these delayed thoracic procedures. Overall, the most common reasons cites included retained hemothoraces and bilothoraces. We also had 4 cases of empyemas and 1 failure of diaphragm repair in the initial repair group. *VATS: video-assisted thoracoscopic surgery

Summary When comparing patients who underwent diaphragm repair versus those who did not: No difference in mortality when comparing both groups Increased hospital LOS, ICU LOS, and ventilator days in group who was repaired No difference in delayed VATS or thoracotomies No difference in infectious complications Incidence of bilomas higher in group who underwent diaphragm repair, other complications related to bile leaks were not statistically different So to summarize, when we compared patients who underwent diaphragm repair versus those who did not have their diaphragm repaired we found: No difference in mortality between the two groups, no differences in the need for delayed thoracic surgery and no differences in any infecitous complications. Finally, while the incidence of bilomas was found to be higher in the group who did not undergo diaphragm repair, other more serious complications related to bile leaks including biliopleural fistulas and bilothoraces were found to be similar.

Conclusions Non-operative management of penetrating right diaphragm injuries appears to be a safe approach without an increased risk of biliary complications Findings suggest that operative intervention only to repair a penetrating diaphragmatic injury is not warranted So in conclusion, our data suggests that the non-operative management of penetrating RTA injuries appears to be a safe approach without an increased risk of biliary complications. Finally, our findings suggests that operative intervention only to repair a penetrating diaphragmatic injury is not warranted as non-operative management does not result in a higher rate of complications.

Questions? Thank you so much for your attention and I’ll be happy to take any questions.