Comparative effectiveness of intracranial hypertension management guided by ventricular versus intraparenchymal pressure monitoring: a CENTER-TBI study

Victor Volovici, Dana Pisică, Benjamin Y Gravesteijn, Clemens M F Dirven, Ewout W Steyerberg, Ari Ercole, Nino Stocchetti, David Nelson, David K Menon, Giuseppe Citerio, Mathieu van der Jagt, Andrew I R Maas, Iain K Haitsma, Hester F Lingsma, CENTER-TBI investigators, participants for the ICU stratum, Cecilia Åkerlund, Krisztina Amrein, Nada Andelic, Lasse Andreassen, Gérard Audibert, Philippe Azouvi, Maria Luisa Azzolini, Ronald Bartels, Ronny Beer, Bo-Michael Bellander, Habib Benali, Maurizio Berardino, Luigi Beretta, Erta Beqiri, Morten Blaabjerg, Stine Borgen Lund, Camilla Brorsson, Andras Buki, Manuel Cabeleira, Alessio Caccioppola, Emiliana Calappi, Maria Rosa Calvi, Peter Cameron, Guillermo Carbayo Lozano, Ana M Castaño-León, Simona Cavallo, Giorgio Chevallard, Arturo Chieregato, Mark Coburn, Jonathan Coles, Jamie D Cooper, Marta Correia, Endre Czeiter, Marek Czosnyka, Claire Dahyot-Fizelier, Paul Dark, Véronique De Keyser, Vincent Degos, Francesco Della Corte, Hugo den Boogert, Bart Depreitere, Dula Dilvesi, Abhishek Dixit, Jens Dreier, Guy-Loup Dulière, Erzsébet Ezer, Martin Fabricius, Kelly Foks, Shirin Frisvold, Alex Furmanov, Damien Galanaud, Dashiell Gantner, Alexandre Ghuysen, Lelde Giga, Jagos Golubovic, Pedro A Gomez, Francesca Grossi, Deepak Gupta, Iain Haitsma, Eirik Helseth, Peter J Hutchinson, Stefan Jankowski, Faye Johnson, Mladen Karan, Angelos G Kolias, Daniel Kondziella, Evgenios Koraropoulos, Lars-Owe Koskinen, Noémi Kovács, Ana Kowark, Alfonso Lagares, Steven Laureys, Didier Ledoux, Aurelie Lejeune, Roger Lightfoot, Alex Manara, Costanza Martino, Hugues Maréchal, Julia Mattern, Catherine McMahon, Tomas Menovsky, Benoit Misset, Visakh Muraleedharan, Lynnette Murray, Ancuta Negru, Virginia Newcombe, József Nyirádi, Fabrizio Ortolano, Jean-François Payen, Vincent Perlbarg, Paolo Persona, Anna Piippo-Karjalainen, Horia Ples, Inigo Pomposo, Jussi P Posti, Louis Puybasset, Andreea Radoi, Arminas Ragauskas, Rahul Raj, Jonathan Rhodes, Sophie Richter, Saulius Rocka, Cecilie Roe, Olav Roise, Jeffrey V Rosenfeld, Christina Rosenlund, Guy Rosenthal, Rolf Rossaint, Sandra Rossi, Juan Sahuquillo, Oddrun Sandrød, Oliver Sakowitz, Renan Sanchez-Porras, Kari Schirmer-Mikalsen, Rico Frederik Schou, Peter Smielewski, Abayomi Sorinola, Emmanuel Stamatakis, Nina Sundström, Riikka Takala, Viktória Tamás, Tomas Tamosuitis, Olli Tenovuo, Matt Thomas, Dick Tibboel, Christos Tolias, Tony Trapani, Cristina Maria Tudora, Peter Vajkoczy, Shirley Vallance, Egils Valeinis, Zoltán Vámos, Gregory Van der Steen, Roel P J van Wijk, Alessia Vargiolu, Emmanuel Vega, Anne Vik, Rimantas Vilcinis, Petar Vulekovic, Guy Williams, Stefan Winzeck, Stefan Wolf, Alexander Younsi, Frederick A Zeiler, Agate Ziverte, Hans Clusmann, Daphne Voormolen, Jeroen T J M van Dijck, Thomas A van Essen, Victor Volovici, Dana Pisică, Benjamin Y Gravesteijn, Clemens M F Dirven, Ewout W Steyerberg, Ari Ercole, Nino Stocchetti, David Nelson, David K Menon, Giuseppe Citerio, Mathieu van der Jagt, Andrew I R Maas, Iain K Haitsma, Hester F Lingsma, CENTER-TBI investigators, participants for the ICU stratum, Cecilia Åkerlund, Krisztina Amrein, Nada Andelic, Lasse Andreassen, Gérard Audibert, Philippe Azouvi, Maria Luisa Azzolini, Ronald Bartels, Ronny Beer, Bo-Michael Bellander, Habib Benali, Maurizio Berardino, Luigi Beretta, Erta Beqiri, Morten Blaabjerg, Stine Borgen Lund, Camilla Brorsson, Andras Buki, Manuel Cabeleira, Alessio Caccioppola, Emiliana Calappi, Maria Rosa Calvi, Peter Cameron, Guillermo Carbayo Lozano, Ana M Castaño-León, Simona Cavallo, Giorgio Chevallard, Arturo Chieregato, Mark Coburn, Jonathan Coles, Jamie D Cooper, Marta Correia, Endre Czeiter, Marek Czosnyka, Claire Dahyot-Fizelier, Paul Dark, Véronique De Keyser, Vincent Degos, Francesco Della Corte, Hugo den Boogert, Bart Depreitere, Dula Dilvesi, Abhishek Dixit, Jens Dreier, Guy-Loup Dulière, Erzsébet Ezer, Martin Fabricius, Kelly Foks, Shirin Frisvold, Alex Furmanov, Damien Galanaud, Dashiell Gantner, Alexandre Ghuysen, Lelde Giga, Jagos Golubovic, Pedro A Gomez, Francesca Grossi, Deepak Gupta, Iain Haitsma, Eirik Helseth, Peter J Hutchinson, Stefan Jankowski, Faye Johnson, Mladen Karan, Angelos G Kolias, Daniel Kondziella, Evgenios Koraropoulos, Lars-Owe Koskinen, Noémi Kovács, Ana Kowark, Alfonso Lagares, Steven Laureys, Didier Ledoux, Aurelie Lejeune, Roger Lightfoot, Alex Manara, Costanza Martino, Hugues Maréchal, Julia Mattern, Catherine McMahon, Tomas Menovsky, Benoit Misset, Visakh Muraleedharan, Lynnette Murray, Ancuta Negru, Virginia Newcombe, József Nyirádi, Fabrizio Ortolano, Jean-François Payen, Vincent Perlbarg, Paolo Persona, Anna Piippo-Karjalainen, Horia Ples, Inigo Pomposo, Jussi P Posti, Louis Puybasset, Andreea Radoi, Arminas Ragauskas, Rahul Raj, Jonathan Rhodes, Sophie Richter, Saulius Rocka, Cecilie Roe, Olav Roise, Jeffrey V Rosenfeld, Christina Rosenlund, Guy Rosenthal, Rolf Rossaint, Sandra Rossi, Juan Sahuquillo, Oddrun Sandrød, Oliver Sakowitz, Renan Sanchez-Porras, Kari Schirmer-Mikalsen, Rico Frederik Schou, Peter Smielewski, Abayomi Sorinola, Emmanuel Stamatakis, Nina Sundström, Riikka Takala, Viktória Tamás, Tomas Tamosuitis, Olli Tenovuo, Matt Thomas, Dick Tibboel, Christos Tolias, Tony Trapani, Cristina Maria Tudora, Peter Vajkoczy, Shirley Vallance, Egils Valeinis, Zoltán Vámos, Gregory Van der Steen, Roel P J van Wijk, Alessia Vargiolu, Emmanuel Vega, Anne Vik, Rimantas Vilcinis, Petar Vulekovic, Guy Williams, Stefan Winzeck, Stefan Wolf, Alexander Younsi, Frederick A Zeiler, Agate Ziverte, Hans Clusmann, Daphne Voormolen, Jeroen T J M van Dijck, Thomas A van Essen

Abstract

Objective: To compare outcomes between patients with primary external ventricular device (EVD)-driven treatment of intracranial hypertension and those with primary intraparenchymal monitor (IP)-driven treatment.

Methods: The CENTER-TBI study is a prospective, multicenter, longitudinal observational cohort study that enrolled patients of all TBI severities from 62 participating centers (mainly level I trauma centers) across Europe between 2015 and 2017. Functional outcome was assessed at 6 months and a year. We used multivariable adjusted instrumental variable (IV) analysis with "center" as instrument and logistic regression with covariate adjustment to determine the effect estimate of EVD on 6-month functional outcome.

Results: A total of 878 patients of all TBI severities with an indication for intracranial pressure (ICP) monitoring were included in the present study, of whom 739 (84%) patients had an IP monitor and 139 (16%) an EVD. Patients included were predominantly male (74% in the IP monitor and 76% in the EVD group), with a median age of 46 years in the IP group and 48 in the EVD group. Six-month GOS-E was similar between IP and EVD patients (adjusted odds ratio (aOR) and 95% confidence interval [CI] OR 0.74 and 95% CI [0.36-1.52], adjusted IV analysis). The length of intensive care unit stay was greater in the EVD group than in the IP group (adjusted rate ratio [95% CI] 1.70 [1.34-2.12], IV analysis). One hundred eighty-seven of the 739 patients in the IP group (25%) required an EVD due to refractory ICPs.

Conclusion: We found no major differences in outcomes of patients with TBI when comparing EVD-guided and IP monitor-guided ICP management. In our cohort, a quarter of patients that initially received an IP monitor required an EVD later for ICP control. The prevalence of complications was higher in the EVD group.

Protocol: The core study is registered with ClinicalTrials.gov , number NCT02210221, and the Resource Identification Portal (RRID: SCR_015582).

Keywords: CENTER-TBI; EVD; External ventricular devices; ICP; Intracranial hypertension; Intracranial pressure monitoring; Intraparenchymal monitors; Severe TBI; Traumatic brain injury.

Conflict of interest statement

The authors declare no competing interests.

© 2022. The Author(s).

Figures

Fig. 1
Fig. 1
Median ICP and therapy intensity level (TIL) (scores for draining CSF were not taken into consideration) per day for both groups. A Median ICP per day for both groups. B Median TIL per day for both groups
Fig. 2
Fig. 2
Absolute GOS-E numbers for both groups. Because of the merging of postal questionnaires and in-person interviews, 2 and 3 were merged in one category, represented as 3 below

References

    1. Aiolfi A, Khor D, Cho J, Benjamin E, Inaba K, Demetriades D. Intracranial pressure monitoring in severe blunt head trauma: does the type of monitoring device matter? J Neurosurg. 2018;128:828–833. doi: 10.3171/2016.11.JNS162198.
    1. Åkerlund CA, Donnelly J, Zeiler FA, Helbok R, Holst A, Cabeleira M, Güiza F, Meyfroidt G, Czosnyka M, Smielewski P, Stocchetti N, Ercole A, Nelson DW. Impact of duration and magnitude of raised intracranial pressure on outcome after severe traumatic brain injury: a CENTER-TBI high-resolution group study. PLoS ONE. 2020;15:e0243427. doi: 10.1371/journal.pone.0243427.
    1. Bales JW, Bonow RH, Buckley RT, Barber J, Temkin N, Chesnut RM. Primary external ventricular drainage catheter versus intraparenchymal ICP monitoring: outcome analysis. Neurocrit Care. 2019;31:11–21. doi: 10.1007/s12028-019-00712-9.
    1. Carney N, Totten AM, O'Reilly C, Ullman JS, Hawryluk GW, Bell MJ, Bratton SL, Chesnut R, Harris OA, Kissoon N, Rubiano AM, Shutter L, Tasker RC, Vavilala MS, Wilberger J, Wright DW, Ghajar J (2017) Guidelines for the management of severe traumatic brain injury, Fourth Edition. Neurosurgery 80:6–15. 10.1227/neu.0000000000001432
    1. Cnossen MC, Huijben JA, van der Jagt M, Volovici V, van Essen T, Polinder S, Nelson D, Ercole A, Stocchetti N, Citerio G, Peul WC, Maas AIR, Menon D, Steyerberg EW, Lingsma HF, investigators C-T, Variation in monitoring and treatment policies for intracranial hypertension in traumatic brain injury: a survey in 66 neurotrauma centers participating in the CENTER-TBI study. Crit Care. 2017;21:233. doi: 10.1186/s13054-017-1816-9.
    1. Cnossen MC, Lingsma HF, Maas AI, Menon DK, Steyerberg EW. Estimating treatment effectiveness of intracranial pressure monitoring in traumatic brain injury. Crit Care Med. 2015;43:e599. doi: 10.1097/CCM.0000000000001292.
    1. Cnossen MC, van Essen TA, Ceyisakar IE, Polinder S, Andriessen TM, van der Naalt J, Haitsma I, Horn J, Franschman G, Vos PE, Peul WC, Menon DK, Maas AI, Steyerberg EW, Lingsma HF. Adjusting for confounding by indication in observational studies: a case study in traumatic brain injury. Clin Epidemiol. 2018;10:841–852. doi: 10.2147/clep.S154500.
    1. Huijben JA, Dixit A, Stocchetti N, Maas AIR, Lingsma HF, van der Jagt M, Nelson D, Citerio G, Wilson L, Menon DK, Ercole A. Use and impact of high intensity treatments in patients with traumatic brain injury across Europe: a CENTER-TBI analysis. Crit Care. 2021;25:78. doi: 10.1186/s13054-020-03370-y.
    1. Huijben JA, Wiegers EJA, Lingsma HF, Citerio G, Maas AIR, Menon DK, Ercole A, Nelson D, van der Jagt M, Steyerberg EW, Helbok R, Lecky F, Peul W, Birg T, Zoerle T, Carbonara M, Stocchetti N. Changing care pathways and between-center practice variations in intensive care for traumatic brain injury across Europe: a CENTER-TBI analysis. Intensive Care Med. 2020;46:995–1004. doi: 10.1007/s00134-020-05965-z.
    1. Kasotakis G, Michailidou M, Bramos A, Chang Y, Velmahos G, Alam H, King D, De Moya MA. Intraparenchymal vs extracranial ventricular drain intracranial pressure monitors in traumatic brain injury: less is more? J Am Coll Surg. 2012;214:950–957. doi: 10.1016/j.jamcollsurg.2012.03.004.
    1. Liu H, Wang W, Cheng F, Yuan Q, Yang J, Hu J, Ren G. External ventricular drains versus intraparenchymal intracranial pressure monitors in traumatic brain injury: a prospective observational study. World Neurosurg. 2015;83:794–800. doi: 10.1016/j.wneu.2014.12.040.
    1. Lohr KN. Comparative effectiveness research methods: symposium overview and summary. Med Care. 2010;48:S3–6. doi: 10.1097/MLR.0b013e3181e10434.
    1. Lousdal ML. An introduction to instrumental variable assumptions, validation and estimation. Emerg Themes Epidemiol. 2018;15:1. doi: 10.1186/s12982-018-0069-7.
    1. Maas AI, Menon DK, Steyerberg EW, Citerio G, Lecky F, Manley GT, Hill S, Legrand V, Sorgner A, Participants C-T, Investigators Collaborative European NeuroTrauma Effectiveness Research in Traumatic Brain Injury (CENTER-TBI): a prospective longitudinal observational study. Neurosurgery. 2015;76:67–80. doi: 10.1227/NEU.0000000000000575.
    1. Martens EP, Pestman WR, de Boer A, Belitser SV, Klungel OH. Instrumental variables: application and limitations. Epidemiology. 2006;17:260–267. doi: 10.1097/01.ede.0000215160.88317.cb.
    1. Roozenbeek B, Lingsma HF, Lecky FE, Lu J, Weir J, Butcher I, McHugh GS, Murray GD, Perel P, Maas AI, Steyerberg EW, International Mission on Prognosis Analysis of Clinical Trials in Traumatic Brain Injury Study G, Corticosteroid Randomisation After Significant Head Injury Trial C, Trauma A, Research N Prediction of outcome after moderate and severe traumatic brain injury: external validation of the International Mission on Prognosis and Analysis of Clinical Trials (IMPACT) and Corticoid Randomisation After Significant Head injury (CRASH) prognostic models. Crit Care Med. 2012;40:1609–1617. doi: 10.1097/CCM.0b013e31824519ce.
    1. Schneeweiss S, Seeger JD, Jackson JW, Smith SR. Methods for comparative effectiveness research/patient-centered outcomes research: from efficacy to effectiveness. J Clin Epidemiol. 2013;66:S1–4. doi: 10.1016/j.jclinepi.2013.05.012.
    1. Shore PM, Thomas NJ, Clark RS, Adelson PD, Wisniewski SR, Janesko KL, Bayir H, Jackson EK, Kochanek PM. Continuous versus intermittent cerebrospinal fluid drainage after severe traumatic brain injury in children: effect on biochemical markers. J Neurotrauma. 2004;21:1113–1122. doi: 10.1089/neu.2004.21.1113.
    1. Steyerberg EW, Wiegers E, Sewalt C, Buki A, Citerio G, De Keyser V, Ercole A, Kunzmann K, Lanyon L, Lecky F, Lingsma H, Manley G, Nelson D, Peul W, Stocchetti N, von Steinbüchel N, Vande Vyvere T, Verheyden J, Wilson L, Maas AIR, Menon DK. Case-mix, care pathways, and outcomes in patients with traumatic brain injury in CENTER-TBI: a European prospective, multicentre, longitudinal, cohort study. The Lancet Neurology. 2019;18:923–934. doi: 10.1016/s1474-4422(19)30232-7.
    1. Volovici V, Ercole A, Citerio G, Stocchetti N, Haitsma IK, Huijben JA, Dirven CMF, van der Jagt M, Steyerberg EW, Nelson D, Cnossen MC, Maas AIR, Polinder S, Menon DK, Lingsma HF. Variation in guideline implementation and adherence regarding severe traumatic brain injury treatment: a CENTER-TBI survey study in Europe. World Neurosurg. 2019 doi: 10.1016/j.wneu.2019.01.116.
    1. Volovici V, Huijben JA, Ercole A, Stocchetti N, Dirven CMF, van der Jagt M, Steyerberg EW, Lingsma HF, Menon DK, Maas AIR, Haitsma IK (2019) Ventricular drainage catheters versus intracranial parenchymal catheters for intracranial pressure monitoring-based management of traumatic brain injury: a systematic review and meta-analysis. J Neurotrauma 36(7):988–995. 10.1089/neu.2018.6086
    1. Volovici V, Steyerberg EW. Lost in translation between evidence and recommendations: expert opinion is needed to define “level I”. World Neurosurg. 2021 doi: 10.1016/j.wneu.2021.03.095.
    1. Volovici V, Steyerberg EW, Cnossen MC, Haitsma IK, Dirven CMF, Maas AIR, Lingsma HF. Evolution of evidence and guideline recommendations for the medical management of severe traumatic brain injury. J Neurotrauma. 2019;36:3183–3189. doi: 10.1089/neu.2019.6474.
    1. Williams CM, Skinner EH, James AM, Cook JL, McPhail SM, Haines TP. Comparative effectiveness research for the clinician researcher: a framework for making a methodological design choice. Trials. 2016;17:406. doi: 10.1186/s13063-016-1535-6.
    1. Zuercher P, Groen JL, Aries MJ, Steyerberg EW, Maas AI, Ercole A, Menon DK. Reliability and validity of the therapy intensity level scale: analysis of clinimetric properties of a novel approach to assess management of intracranial pressure in traumatic brain injury. J Neurotrauma. 2016;33:1768–1774. doi: 10.1089/neu.2015.4266.

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