Supplementary Appendix

Transcription

1 Supplementary Appendix This appendix has been provided by the authors to give readers additional information about their work. Supplement to: Cooper DJ, Rosenfeld JV, Murray L, et al. Decompressive craniectomy in diffuse traumatic brain injury. N Engl J Med 2011;364: DOI: /NEJMoa (PDF updated April 5, 2011.)

2 Supplementary Appendix Table of Contents The DECRA Trial Committees and Members... 2 Surgical Technique: Bi-fronto-temporal Decompressive Craniectomy in Diffuse Traumatic Brain Injury... 3 Supplementary Figure 1. Assessment, randomization and follow-up of the trial Supplementary Table 1. Times Supplementary Table 2. Processes of care Supplementary Figure 2. Functional outcomes at 6 months after injury assessed by Extended Glasgow Outcomes Scale (GOSE) in decompressive craniectomy (DC) and standard care groups Supplementary Table 3. Surgical complications of craniectomy and subsequent cranioplasty for patients in the craniectomy group... 9 Supplementary Table 4. Causes of death Supplementary Figure 3. CT brain scans: Panels A and B Supplementary Figure 4. Operative photograph

3 The DECRA Trial Committees and Members The DECRA Trial Investigators were as follows: Co-Chief Investigators D.J. Cooper, J.V. Rosenfeld; Executive Committee D.J. Cooper (Chair), J.V. Rosenfeld, L. Murray, Y.M. Arabi, A.R. Davies, P. D Urso, T. Kossmann, J. Ponsford, I. Seppelt, P. Reilly, R. Wolfe; Data and Safety Monitoring Committee P. Myles (Chair), R. Bellomo, J. Santamaria, P. Komasarof, B. Byrne; Study Statistical Center Monash University, Melbourne, Australia R. Wolfe, P. Simpson; Study Coordinating Center The Alfred Hospital, Melbourne, Australia; Outcome Assessors S. Vallance, B. Howe, M. Kishi; Site Investigators (In order of patient numbers at each site recruited into the DECRA trial) Alfred Hospital, Melbourne, Australia D.J. Cooper, J.V. Rosenfeld, L. Murray, A.R. Davies, P. Hwang, V. Pellegrino; King Saud Bin Abdulaziz University for Health Sciences, Riyadh, Kingdom of Saudi Arabia Y.M. Arabi, S. Al-Qahtani, A. Al-Ferayan, N. Russell, A. Rishu; Royal Perth Hospital, Perth, Australia G. Dobb, S. Honeybul, J. Chamberlain, A. Gould, G. McEntaggart; Nepean Hospital, Sydney, Australia I. Seppelt, V. Casikar, S. Nair, K. Seex, L. Weisbrodt; John Hunter Hospital, Newcastle, Australia P. Harrigan, R. Ferch, B. McFadyen, E. Taylor, M. Hardie; Royal Melbourne Hospital, Melbourne, Australia J. Laidlaw, C. MacIsaac, M. Robertson, J. Presneill, T. Caf; Royal North Shore Hospital, Sydney, Australia S. Finfer, M. Briggs, R. Lee, N. Little, A. O Connor; Princess Alexandra Hospital, Brisbane, Australia C. Joyce, A. Nowitzke, B. Venkatesh, M. Harward, J. Helyar; Wellington Hospital, Wellington, New Zealand D. Dinsdale, M. Hunn, L. Andrew, D. Mackle, S. Mortimer; Auckland Hospital, Auckland New Zealand C. McArthur, A. Law, S. Streat, L. Newby; Gold Coast Hospital, Southport, Queensland B. Richards, T. Withers, M. Tallott; Sir Charles Gairdner Hospital, Perth, Australia P.V. van Heerden, S. Baker, M. Pinder, N. Knuckey, B. Roberts; Liverpool Hospital, Sydney, Australia M. Parr, R. Calcroft, J. Van Gelder, M. Sheridan, S. Micallef; Royal Adelaide Hospital, Adelaide, Australia N. Edwards, B. Brophy, M. Chapman, P. Reilly, S. O Connor; Christchurch Hospital, Christchurch, New Zealand S. Henderson, R. Boet, N. Finnis, M. Macfarlane, J. Mehrtens. The following hospitals commenced screening but did not enrol patients: Australia Westmead Hospital, Sydney, Royal Hobart Hospital, Hobart, Wollongong Hospital, Wollongong, Flinders Medical Centre, Adelaide; New Zealand Waikato Hospital, Hamilton; Canada Vancouver General Hospital, Vancouver, Royal Columbian Hospital, Vancouver, Sunnybrook Medical Centre, Toronto, Hamilton General Hospital, Hamilton; U.S.A. Baltimore Shock Trauma Center, Maryland, University of Pennsylvania, Pennsylvania. 2

4 Surgical Technique: Bi-fronto-temporal Decompressive Craniectomy in Diffuse Traumatic Brain Injury. The technique described by Polin et al 17 was used with minor modification. Senior neurosurgeons from all participating centres were given oral and written instruction by Dr J.V. Rosenfeld on our recommended craniectomy method and all their questions were answered. A diagram was supplied. In this way, the surgical procedure was standardized. The operation comprised a bicoronal incision raising the pericranium with the scalp flap. A bi-frontotemporo-parietal decompressive craniectomy was performed with the bone flap extending across the midline. The surgeon was permitted to divide the bone flap at or near the midline for ease of removal but no strip of bone was left over the sagittal sinus. The temporalis muscle was reflected inferiorly and posteriorly on each side down to or near to the level of the floor of the middle cranial fossa. Burr holes were located either side of the sagittal sinus at the posterior extent, bilaterally at the keyhole position just posterior to the zygomatic process of the frontal bone and if needed at the root of the zygoma inferiorly. The posterior limit extended at least back to the coronal suture posteriorly but many surgeons extended posteriorly 2 or 3 centimeters beyond this point at the midline. The bone cut was extended vertically and inferiorly on each side, thus passing posterior to the coronal suture and through the parietal bone and temporal bone. This cut was continued forwards low down on the squamous temporal bone and forwards across the greater wing of the sphenoid bone across to the burr hole at the keyhole position. The inferior bone cut was made just above the supra-orbital ridges. To avoid opening the frontal sinus, the inferior bone cut passed above the frontal bone overlying the sinus. The neurosurgeon judged this based on the size of the sinus on the preoperative CT scan. Following removal of the bone flap, an extension of the craniectomy was performed bilaterally by removing the squamous temporal bone and the greater wing of sphenoid with rongeurs close to the floor of the middle fossa on each side. Thus, bilateral sub-temporal decompressions were performed (Figure 3 in the Supplementary Appendix). The dura was opened over the frontal lobes in one of two ways: a large cruciate incision bilaterally (Figure 4 in the Supplementary Appendix), or a large L shaped incision with the lower corner of the L facing laterally and the horizontal limb pointing medially toward the sagittal sinus. The advantage to the latter method is that the cerebral veins are not disturbed medially by this incision although the co-ordinating center did not encounter any venous injury with the cruciate method. Kinking of large cortical veins at the cut dural edge was prevented by small radial cuts overlying the veins. Kinking of the sagittal sinus at the edge of the craniectomy was not an issue. Our procedure did not involve a fishmouth opening of the dura and dividing the sagittal sinus and falx as described by Polin et al 17. The durotomy was covered with a synthetic dural or fascial patch (temporalis or pericranium). The patch was placed to protect the surface of the brain from adhering to the scalp and to act as a further barrier to infection. The patches were tacked into position with sutures so that they did not migrate. Water-tight dural closure was not required (Figure 4 in the Supplementary Appendix). Attention was directed to haemostasis prior to closure of the scalp, but low pressure suction drains were placed beneath the scalp flap if oozing was a problem. These were usually removed after 24 hours and the exit wounds sutured to avoid CSF leak and infection. 3

5 In each patient, when possible, the initial ICP monitor was placed posterior to the line of a potential craniectomy incision so that it could be left undisturbed by the craniectomy procedure. The ICP monitor utilizing ventricular catheter and/or parenchymal transducer (± optional brain oxygen (PbrO 2 ) and temperature monitor) were replaced prior to closure and brought out through separate stab incisions posterior to the scalp flap. The bone flap was replaced once bone swelling resolved and the patient had improved and left the intensive care unit (6-12 weeks). The bone flap was stored in a clinical freezer at minus 70 C until reinsertion or it was implanted in the subcutaneous tissue of the abdominal wall as an alternative. 4

6 Supplementary Figure 1. Assessment, randomization and follow-up of the trial. Patients with severe traumatic brain injury assessed for eligibility (n=3478) Excluded (n=3302) Mass lesions (n=1222) Unsurvivable/poor prognosis (n=420) Age <15 & >60 years (n=211) ICP controlled (n=1105) Other (n=344) Declined Consent (n=21) Randomized (n=155) Allocated to craniectomy (n=73) Received craniectomy (n=70) Did not receive craniectomy (n=3) ICP stabilized prior to craniectomy (n=2) Incorrectly randomized (n=1) Allocated to standard care (n=82) Received standard care (n=78) Received craniectomy (n=4) Analyzed (n=73) Lost to follow up (n=0) Withdrew consent (n=0) Analyzed (n=82) Lost to follow up (n=0) Withdrew consent (n=0) 5

7 Supplementary Table 1. Times. Decompressive Craniectomy N=73 Median (IQR) Standard Care N=82 Median (IQR) Time from injury to hospital (hrs) 1.0 (0.8 to 1.8) 1.2 (0.7 to 1.9) Time from injury to randomization (hrs) 35.2 (23.3 to 52.8) 34.8 (25.8 to 45.4) Time from injury to surgery (hrs) 38.1 (27.1 to 55.0) 102 (73 to 174) Time from randomization to surgery (hrs) 2.3 (1.4 to 3.8) 75.8 (42.6 to 121.1) Time from craniectomy to cranioplasty (days) 76.6 (46.4 to 131.4) (95.4 to 162.7) Length of surgery for craniectomy (hrs) 2.8 (2.3 to 3.3) 2.8 (2.3 to 4.0) Length of surgery for cranioplasty (hrs) 2.4 (1.8 to 2.9) 2.6 (2.3 to 2.9) 6

8 Supplementary Table 2. Processes of care. Intracranial pressure (ICP) Parenchymal monitor inserted; n (%) Decompressive Craniectomy N=73 Standard Care N=82 P value 50 (68) 52 (64) 0.57 ICP Extra ventricular drain monitor inserted; n* (%) 49 (67) 59 (72) 0.51 Pre randomization Hypertonic saline 3% (mls); median (IQR) 650 (133 to 1333) 720 (200 to 1404) 0.40 Mannitol 20% (mls); n (%) (55) 51 (65) (32) 23 (29) (13) 5 (6) Thiopentone (gm); n (%) (71) 55 (67) (22) 19 (23) (7) 8 (10) Neuromuscular blockade; n (%) 57 (78) 63 (77) 0.85 Cerebrospinal fluid venting n (%) 46 (100^) 50 (100^) 1.0 Post randomization Hypertonic saline 3% (mls); median (IQR) 425 (0 to 1983) 1475 (200 to 3875) 0.01 Mannitol 20% (mls); n (%) (82) 55 (68) (18) 16 (20) (0) 10 (12) Thiopentone (gm); n (%) < (68) 19 (23) (32) 49 (60) (0) 14 (17) Paralysis; n (%) 42 (58) 70 (85) <0.001 Cerebrospinal fluid venting; n (%) 33 (77#) 57 (97#) Chi-square test to compare proportions, Wilcoxon rank sum test to compare distributions *Of these numbers, 3 in the decompressive craniectomy group and 9 in the standard care group had the extra ventricular drain monitor inserted post randomization ^ Percentage of those with extra ventricular drain monitor inserted pre randomization # Percentage of those with extra ventricular drain monitor inserted; 6 in decompressive craniectomy group had missing drain data and were excluded from calculation of percentage 7

9 Supplementary Figure 2. Functional outcomes at 6 months after injury assessed by the Extended Glasgow Outcomes Scale (GOSE) in decompressive craniectomy (DC) and standard care groups. GOSE 1 is dead; 2 is vegetative survival; 3/4 is severe disability; 5/6 is moderate disability (independent); 7/8 is good (independent). Grade 8 is pre-injury neurological function. Favorable outcome is GOSE

10 Supplementary Table 3. Surgical complications of craniectomy and subsequent cranioplasty for patients in the craniectomy group* Adverse events n (%) Craniectomy N=70 Cranioplasty N=56 Wound infection/breakdown 2 (3) 3 (6) Meningitis/Ventriculitis 2 (3) 0 (0) Subgaleal infection 0 (0) 2 (4) Cerebral abscess 1 (1) 1 (2) CSF leak 4 (6) 0 (0) Subgaleal hematoma 3 (4) 2 (4) Subdural/Extradural/Intracerebral hematoma 1 (1) 2 (4) Cerebral infarction 1 (1) 0 (0) Subgaleal infection 0 (0) 2 (4) *70 of 73 craniectomy group patients received the first operation per protocol (see supplementary Figure 1). Not all craniectomy patients survived to have the subsequent cranioplasty (56 of 70). Cranioplasty patients had their operation reversed by 6 months. 9

11 Supplementary Table 4. Causes of death. Decompressive Craniectomy N=73 Standard Care N=82 Treatment withdrawn due to TBI n (%) 11 (15) 8 (10) Brain death n (%) 2 (3) 4 (5) Pneumonia n (%) 0 (0) 1 (1) Septic shock n (%) 1 (1) 1 (1) Neurogenic pulmonary edema n (%) 0 (0) 1 (1) 10

12 Supplementary Figure 3. CT brain scans: Panels A and B. Examples to clarify extent of craniectomy: Panel A. Post-craniectomy lateral scout CT brain scan Panel B. Three days post-bi-fronto-temporo-parietal craniectomy 11

13 Supplementary Figure 4. Operative photograph. Operative photograph showing extent of craniectomy and magnitude of cruciate incisions in the dura. Surgicel is placed over the sagittal sinus. A ventricular drain is in situ. 12