TEVAR for trauma is here to stay: Advances in the Treatment of Blunt Thoracic Aortic Injury

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1 TEVAR for trauma is here to stay: Advances in the Treatment of Blunt Thoracic Aortic Injury Megan Brenner MD MS RPVI FACS Associate Professor of Surgery Division of Trauma/Surgical Critical Care, RA Cowley Shock Trauma Center Division of Vascular Surgery, University of Maryland School of Medicine

2 Blunt Thoracic Aortic Injury: 2 nd leading cause of death Majority - MVC Rapid deceleration

3 Deceleration Mobile Fixed

4 Diagnosis H&P - Mechanism CXR Hematoma Anomalies Equivocal CT Angiogram IVUS / Angiogram

5 CT Scan

6 Aortogram

7 IVUS No contrast No radiation Real time accurate measurement Morphology (plaque, thrombus, ca++)

8 The Utility of Intravascular Ultrasound Compared to Angiography in the Diagnosis of Blunt Traumatic Aortic Injury A Azizzadeh, J Valdes, CC Miller, LL Nguyen, AL Estrera, K Charlton-Ouw, SM Coogan, JB Holcomb, and HJ Safi CTA widely used as screening for BTAI After equivocal CTA, additional imaging required IVUS more sensitive than angiogram JVS March 2011

9 AAST I and II Demetriades et al

10 AAST I & AAST II Transition in diagnosis Angiogram / echocardiogram >>> CTA Improved outcomes with transition to TEVAR Mortality decreased from 22.0% to 13.0% Paraplegia decreased from 8.7% to 1.6% Delayed repair > Immediate repair

11 AAST I & II Studies Prospective, Multicenter Study N = 193 pts TEVAR - related complications = 20%

12 TEVAR the whole answer for BTAI? Need a common nomenclature to guide: Type of treatment provided Timing of intervention Must work across a spectrum of injuries

13 IV Thoracic aorta, descending

14 Layers of the aortic wall

15 2011

16 Treatment Algorithm GRADE I Intimal Tear IVUS / Med TX GRADE II Intramural Hematoma TEVAR / OR GRADE III Pseudoaneurysm TEVAR / OR GRADE IV Rupture TEVAR / OR (Emergent)

17 TEVAR mandated?

18 Same Risk for Early Rupture?

19 Vancouver Simplified System

20 Harborview Minimal Aortic Injuries

21 Parameters for successful non-operative management of traumatic aortic injury Joseph Rabin, MD, Joe DuBose, MD, Clint W. Sliker, MD, James V. O Connor, MD, Thomas M. Scalea, MD, and Bartley P. Griffith, MD The Journal of Thoracic and Cardiovascular Surgery, Volume 147, Issue 1, January 2014, Pages Grade III with SSI Suggest urgent repair Grade III with out SSI Consider delayed repair during hospitalization after initial medical management Grade I and II with SSI consider repair if risk of rupture increased.

22

23 What Optimal Grading Should Do: Determine treatment Medical vs. TEVAR vs. Open repair Guide timing of treatment Emergent vs. Urgent vs. Delayed Guide prediction of natural history and optimal follow-up

24 aortictrauma.org 2014

25 Mission Statement To improve outcomes of patients with traumatic aortic injury (TAI) through education and research. Structure: Non-profit 501(c)(3) organization Board of Directors Multispecialty Medical Advisory Board

26 ATF Multispecialty Scientific Advisory Board (SAB) International leaders in TAI Vascular surgeons CT surgeons Trauma surgeons Radiologists

27 Aortic Trauma Foundation BTAI Study Retrospective study (Jan 2008 Dec 2013) Nine ACS Level 1 Trauma Centers 453 BTAI patients Exclusion if death before imaging (58) or transfer (13) N = 382 BTAI patients

28 Demographics Total (N =382) Age (Mean ± SD) 41.8 ± 17.8 Male, n (%) 278 (72.8%) Mechanism MVC, n (%) 249 (72.8%) MCC, n (%) 55 (14.4%) Fall, n (%) 28 (7.3%) Auto vs. Ped, n (%) 36 (9.4%) Other blunt, n (%) 14 (3.7%) Hypotension (SBP < 90) on arrival, n (%) 56 (14.7%) Admission GCS 8, n (%) 112 (29.3%) ISS (Mean ± SD) 37.5 ± 12.5 AIS Head 3, n (%) 139 (36.4%) AIS Chest 3, n (%) 375 (98.2%) AIS Abdomen 3, n (%) 132 (34.6%) AIS Extremity 3, n (%) 157 (41.1%)

29 Injuries Identified SVS Injury Grade Grade I, n (%) 94 (24.6%) Grade II, n (%) 68 (17.8%) Grade III, n (%) 192 (50.3%) Grade IV, n (%) 28 (7.3%)

30 Imaging and Associated Findings Imaging Modality utilized for diagnosis CTA alone, n (%) 361 (94.5%) CTA + Angiography, n (%) 9 (2.4%) Angiography Alone, n (%) 2 (0.5%) CTA + Angiography + IVUS, n (%) 10 (2.6%) Pseudocarctation, n (%) 13 (3.4%) Mediastinal Hematoma with evidence of compression, n (%) 103 (27.0%) Associated Hemothorax, n (%) 110 (28.8%) Hemothorax > 300 cc, n (%) 40 (10.5%) Hemothorax > 500 cc, n (%) 18 (4.7%) Hemothorax > 1000 cc, n (%) 5 (1.3%)

31 Non-BTAI Specific Treatment Requirements Craniotomy / Craniectomy, n (%) 4 (1.0%) Laparotomy, n (%) 87 (22.8%) Thoracotomy / Sternotomy (not for TAI), n (%) 16 (4.2%) ICU LOS (Mean ± SD) 11.3 ± 12.6 Hospital LOS (Mean ± SD) 19.0 ± 19.5 Ventilator Days (Mean ± SD) 8.2 ± 11.0 PRBC 24 hrs (Mean ± SD) 3.6 ± 6.0 FFP 24 hrs (Mean ± SD) 2.4 ± 4.6

32 Complications Stroke, n (%) 6 (1.6%) Acute Renal Failure, n (%) 26 (6.8%) DVT, n (%) 23 (6.0%) Pulmonary Embolism, n (%) 25 (6.5%) Catheter-related UTI, n (%) 30 (7.9%) Blood Stream Infection, n (%) 46 (12.0%) Hospital-acquired pneumonia, n (%) 36 (9.4%) Ventilator-associated pneumonia, n (%) 50 (13.1%) ALI / ARDS, n (%) 45 (11.8%) Sepsis, n (%) 56 (14.7%)

33 Overall BTAI Mortality (N = 382) In-hospital mortality, n (%) 72 (18.8%) Aortic-related mortality, n (%) 25 (6.5%)

34 Nonoperative Management 123 patients; 31.9% N = 123 patients (31.9% overall) NOM (vs. Open Repair or TEVAR) Older (Mean 44.7 vs. 40.4%, p = 0.028) 76.5% of all Grade I BTAI Less likely to have mediastinal hematoma on CTA Higher overall mortality (35.0% vs. 11.2%, p < 0.001)

35 Nonoperative Management 2 failures (Grade I, IV) => TEVAR Aortic-related mortality = 9.8% vs. 5.0% for repair (Open or TEVAR)

36 Repair (Open / TEVAR) Open Repair (OR) = 61 (16%) TEVAR = 198 (51.8%) TEVAR patients (compared to OR) Older (Mean 41.7 vs. 35.8, p = ) Lower ISS (Mean 35.6 vs. 42.4, p < 0.001) Less mediastinal hematoma (25.8% vs. 50.8%, p < 0.001) Less PRBC required (Mean 3.1 vs. 5.9, p = 0.002) Less FFP required (Mean 3.3 vs. 1.9, p = 0.021)

37 Repair (Open / TEVAR) TEVAR (vs. OR) Lower overall mortality (8.6% vs. 19.7%, p = 0.021) Lower aortic-related mortality (2.5% vs. 13.1%, p = 0.003)

38 TEVAR Devices Characteristics of TEVAR devices utilized (n =198) (4 not recorded; 194 known) Manufacturers Cook % Gore % Medtronic %

39 TEVAR Devices Diameter of Devices (4 not recorded; 194 known) N % Less than 26 mm % mm % mm % Device Lengths (8 not recorded known) Less than or equal 10 cm % Greater than 10 cm % Minimum 6.0 cm Maximum 20.2 cm

40 TEVAR Outcomes Endovascular repair, n (%) 198/382 (51.8%) Subclavian coverage, n (%) 82/198 (41.4%) Endograft malposition at initial TEVAR, n (%) 6/198 (3.0%) Endoleak, n (%) 5/198 (2.5%) Early Stent Fracture, n (%) 0/198 (0%) Early stent migration, n (%) 1/198 (0.5%) Access site pseudoaneurysm, n (%) 1/198 (0.5%) Access site persistent or delayed bleeding requiring intervention, n (%) 1/198 (0.5%) Treatment failure TEVAR, n (%) 6/198 (3.0%) TEVAR salvage, n (%) 2/198 (1.0%) OPEN salvage, n (%) 4/198 (2.0%)

41 TEVAR Outcomes Paralysis after TEVAR = 1 34 mm diameter device; 20 cm coverage No subclavian coverage 81 yo Stroke = 2 Diameters 26, 32 mm; Length 10,15 cm Both underwent L SCA coverage Ages 62, 85

42 SVS Grade I - II Nonoperative management (N = 91) TEVAR (N = 61) p - vlaue No difference in outcomes for patients Age (Mean ± SD) 42.3 ± ± Male, n (%) 64 (66.7%) 41 (67.2%) ISS (Mean ± SD) 34.9 ± ,1 ± Hypotension treated (SBP < 90) on arrival, n (%) with NOM vs. TEVAR 12 (13.0%) for Minimal 8 (13.1%) Admission GCS 8, n (%) 23 (24.7%) 17 (28.3%) AIS Head 3, n (%) 33 (35.1%) 19 (31.1%) AIS Abdomen 3, n (%) 33 (35.1%) 24 (39.3%) BTAI (SVS Grade I II injuries) AIS Extremity 3, n (%) 40 (42.6%) 27 (44.3%) Mediastinal Hematoma with evidence of compression, n (%) 5 (5.2%) 12 (19.7%) Associated Hemothorax, n (%) 15 (15.6%) 15 (24.6%) Goal Blood Pressure achieved with medical adjuncts, n (%) 51 (91.1%) 15 (93.8%) Craniotomy / Craniectomy, n (%) 3 (3.1%) 1 (1.6%) Laportomy, n (%) 17 (17.7%) 17 (27.9%) Thoracotomy / Sternotomy (not for TAI), n (%) 2 (2.1%) 1 (1.6%) SVS presently recommends treatment for ICU LOS (Mean ± SD) 9.8 ± ± Hospital LOS (Mean ± SD) 16.4 ± ± Ventilator Days (Mean ± SD) 6.3 ± ± PRBC 24 hrs (Mean SVS ± SD) Grade II injuries 2.2 ± ± FFP 24 hrs (Mean ± SD) 1.8 ± ± Paralysiss, n (%) 0 (0%) 1 (1.6%) Stroke, n (%) 4 (4.2%) 1 (1.6%) Acute Renal Failure, n (%) 8 (8.3%) 3 (4.9%) DVT, n (%) 4 (4.2%) 6 (9.8%) Pulmonary Embolism, n (%) 4 (4.2%) 6 (9.8%) More investigation needed in this subgroup Catheter-related UTI, n (%) 6 (6.3%) 5 (8.2%) Blood Stream Infection, n (%) 12 (12.5%) 6 (9.8%) Hospital-acquired pneumonia, n (%) 4 (4.2%) 5 (8.2%) Ventilator-associated pneumonia, n (%) 8 (8.3%) 7 (11.5%) ALI / ARDS, n (%) 11 (11.5%) 9 (14.8%) Sepsis, n (%) 9 (9.4%) 11 (18.0%) In-hospital mortality, n (%) 19 (19.8%) 6 (9.8%) Aortic-related mortality, n (%) 0 (0%) 2 (3.3%) 0.149

43 Aortic-related mortality 25 aortic-related mortalities overall All but 7 occurred prior to opportunity for repair All dying before repair attempt ISS > 25 7 deaths occurred after opportunity for repair

44 Deaths after attempt at BTAI repair (N = 7) 2 Grade II; 2 Grade 3; 4 Grade 4 All severely injured 3 GCS 3 on arrival with head AIS > 3 4 abdominal AIS > 3 3 required laparotomy 2 massive transfusions

45 Deaths after attempt at BTAI repair (N = 7) 4 open surgical repairs; 3 TEVAR 5 died within 24 hours of admission one between 24 and 48 hours one at 36 days in ICU with VAP and MOF

46 Independent Predictors of all-cause and aortic-related mortality among BTAI patients Variable Adjusted Odds Ratio (95% CI) p -value All-cause mortality ISS (continuous) 1.06 [ ] Nonoperative Management [ ] < SVS Grade (linear continuous) 2.45 [ ] < Admission Glasgow Coma Score 0.88 [ ] PRBC's required over 1st 24 hours 1.10 [ ] Aortic-related mortality ISS (continuous) 1.07 [ ] SVS Grade (linear continuous) [ ] < TEVAR (dichotomous) 0.21 [ ] AIS Chest (continuous) 6.41 [ ]

47 ATF Survey

48 ATF Survey SVS AAST EAST STS SIR

49

50

51

52

53

54

55 Methods TEVAR for BTAI from December 2004-October 2015 Age, gender, mechanism of injury, admission physiologic data, ISS, TRISS, and hospital/icu length of stay Grade of aortic injury based on the SVS aortic injury scale

56 Results 88 patients Aortic injury grade 2 (2%) grade II 79 (90%) grade III 7 (8%) grade IV

57 Major In-Hospital Complications Major in hospital complication rate was 57% (50) TEVAR related mortality was 0 Overall mortality 6 (6.8%) Intra-abdominal sepsis 1 (1.1%) Cardiac arrest 2 (2.3%) Grade 5 liver injury 1 (1.1%) TBI 2 (2.3%)

58 Paraplegia/Stroke Paraplegia and stroke rate of 0% Decreasing rates since 2008 AAST (0.8% paraplegia and 1.6% stroke) Consistent with recent reports Likely secondary to short treatment zones and compensatory nature of younger patients

59 Percutaneous TEVAR (ptevar) First description of 6Fr Perclose ProGlide systems exclusively in trauma patients Final 10 consecutive patients in the series treated percutaneously No significant access complications with any approach (1 seroma, observed) Approach Patient # (%) Complication Rate Open Femoral 87% 0% Percutaneous Femoral 10 (11.4%) 0% Retroperitoneal Conduit 1 (1%) 0%

60 Heparin SVS recommends heparinization in smaller doses in trauma 23 patients with a TBI were given heparin 10 patients without heparin No adverse events from its use or lack thereof Decision to heparinize should be individualized

61 Upper Extremity Ischemia LSCA covered in 19 patients (21.6%) partially in 7 patients (8%) 2 Carotid LSCA bypasses performed prophylactically No post operative ischemia was identified Revascularization only if necessary CABG, cerebrovascular disease

62 TEVAR-related Complications TEVAR-related complication in 8 patients (9.1%) 4 (4.5%) type 1a 2 (2.3%) type 2 2 (2.3%) type 3 No late endoleaks All type 2 and 3 endoleaks resolved spontaneously Overall TEVAR re-intervention rate was 4.5% Open conversion required in only 2 (2.3%)

63 TEVAR-related Complications Reduction in endoleaks and major vascular injuries Higher rate of endoleak observation and resolution No re interventions necessary after 2009

64 TEVAR-related Complications AAST 2008 Current Review Endoleak 14.4% 9.1% Endoleak Reintervention Conversion to open Major Vascular Injury 12% 4.5% 4.8% 2.3% 4% 0%

65 Follow-Up Post discharge surveillance continues to be a problem No delayed device complications were identified on CT No patients returned with complications Mid to late term device complications are rarely identified in the literature

66 BTAI: Ongoing Areas of Controversy Management of intramural hematoma (G 2) Timing of repair Urgent vs. emergent Prioritizing repair of associated injuries (TBI) Optimal follow-up imaging regimen

67 Future Research ATF-AAST Prospective Registry Optimal Management of Minimal Aortic Injuries Predictors of early rupture Multispecialty consensus on diagnosis and treatment Long-term outcomes Establish natural history

68 Thank you

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