Seizure outcome of pediatric magnetic resonance-guided laser interstitial thermal therapy versus open surgery: A matched noninferiority cohort study

Omar Yossofzai; Scellig Stone; Joseph Madsen; Rahim Moineddin; Shelly Wang; John Ragheb; Ismail Mohamed; Robert Bollo; Dave Clarke; M. Scott Perry; Alexander G. Weil; Jeffrey Raskin; Jonathan Pindrik; Raheel Ahmed; Sandi Lam; Aria Fallah; Cassia Maniquis; Andrea Andrade; George M. Ibrahim; James Drake; James Rutka; Jignesh Tailor; Nicholas Mitsakakis; Klajdi Puka; Elysa Widjaja

doi:10.1111/epi.17451

Seizure outcome of pediatric magnetic resonance-guided laser interstitial thermal therapy versus open surgery: A matched noninferiority cohort study

Omar Yossofzai, Scellig Stone, Joseph Madsen, Rahim Moineddin, Shelly Wang, John Ragheb, Ismail Mohamed, Robert Bollo, Dave Clarke, M. Scott Perry, Alexander G. Weil, Jeffrey Raskin, Jonathan Pindrik, Raheel Ahmed, Sandi Lam, Aria Fallah, Cassia Maniquis, Andrea Andrade, George M. Ibrahim, James DrakeJames Rutka, Jignesh Tailor, Nicholas Mitsakakis, Klajdi Puka, Elysa Widjaja^*

^*Corresponding author for this work

Neurological Surgery

Research output: Contribution to journal › Article › peer-review

15 Scopus citations

Abstract

Objective: Minimally invasive magnetic resonance-guided laser interstitial thermal therapy (MRgLITT) has been proposed as an alternative to open epilepsy surgery, to address concerns regarding the risk of open surgery. Our primary hypothesis was that seizure freedom at 1 year after MRgLITT is noninferior to open surgery in children with drug-resistant epilepsy (DRE). The secondary hypothesis was that MRgLITT has fewer complications and shorter hospitalization than surgery. The primary objective was to compare seizure outcome of MRgLITT to open surgery in children with DRE. The secondary objective was to compare complications and length of hospitalization of the two treatments. Methods: This retrospective multicenter cohort study included children with DRE treated with MRgLITT or open surgery with 1-year follow-up. Exclusion criteria were corpus callosotomy, neurostimulation, multilobar or hemispheric surgery, and lesion with maximal dimension > 60 mm. MRgLITT patients were propensity matched to open surgery patients. The primary outcome was seizure freedom at 1 year posttreatment. The difference in seizure freedom was compared using noninferiority test, with noninferiority margin of −10%. The secondary outcomes were complications and length of hospitalization. Results: One hundred eighty-five MRgLITT patients were matched to 185 open surgery patients. Seizure freedom at 1 year follow-up was observed in 89 of 185 (48.1%) MRgLITT and 114 of 185 (61.6%) open surgery patients (difference = −13.5%, one-sided 97.5% confidence interval = −23.8% to ∞, p_{Noninferiority} =.79). The lower confidence interval boundary of −23.8% was below the prespecified noninferiority margin of −10%. Overall complications were lower in MRgLITT compared to open surgery (10.8% vs. 29.2%, respectively, p <.001). Hospitalization was shorter for MRgLITT than open surgery (3.1 ± 2.9 vs. 7.2 ± 6.1 days, p <.001). Significance: Seizure outcome of MRgLITT at 1 year posttreatment was inferior to open surgery. However, MRgLITT has the advantage of better safety profile and shorter hospitalization. The findings will help counsel children and parents on the benefits and risks of MRgLITT and contribute to informed decision-making on treatment options.

Original language	English (US)
Pages (from-to)	114-126
Number of pages	13
Journal	Epilepsia
Volume	64
Issue number	1
DOIs	https://doi.org/10.1111/epi.17451
State	Published - Jan 2023

Funding

The studied samples were collected during two field campaigns in central Nepal, which were funded by the Italian Ministry of University and Research (Ministero dell'Istruzione, dell'Università e della Ricerca) (PRIN2010–2011, Project No. 2010PMKZX7; PRIN2015, Project No. 2015EC9PJ5) and by the Compagnia di San Paolo and University of Torino (Junior PI Grant, Project No. TO_Call1_2012_0068). Laboratory work was funded by the Italian Ministry of University and Research (PRIN2017, Project No. 2017LMNLAW) and by the University of Torino (Ricerca Locale, ex‐60% 2020 funds: ROLF_RILO_20_01). We thank A. Nagurney for her inspiring and constructive comments, an anonymous reviewer for the helpful review and C. Warren for helpful suggestions and editorial handling, which all significantly improved this work. The study was funded by the Pediatric Epilepsy Research Foundation.

Keywords

drug-resistant epilepsy
laser interstitial thermal therapy
pediatric epilepsy surgery
propensity score
seizure outcome

ASJC Scopus subject areas

Neurology
Clinical Neurology

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10.1111/epi.17451

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Yossofzai, O., Stone, S., Madsen, J., Moineddin, R., Wang, S., Ragheb, J., Mohamed, I., Bollo, R., Clarke, D., Perry, M. S., Weil, A. G., Raskin, J., Pindrik, J., Ahmed, R., Lam, S., Fallah, A., Maniquis, C., Andrade, A., Ibrahim, G. M., ... Widjaja, E. (2023). Seizure outcome of pediatric magnetic resonance-guided laser interstitial thermal therapy versus open surgery: A matched noninferiority cohort study. Epilepsia, 64(1), 114-126. https://doi.org/10.1111/epi.17451

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title = "Seizure outcome of pediatric magnetic resonance-guided laser interstitial thermal therapy versus open surgery: A matched noninferiority cohort study",

abstract = "Objective: Minimally invasive magnetic resonance-guided laser interstitial thermal therapy (MRgLITT) has been proposed as an alternative to open epilepsy surgery, to address concerns regarding the risk of open surgery. Our primary hypothesis was that seizure freedom at 1 year after MRgLITT is noninferior to open surgery in children with drug-resistant epilepsy (DRE). The secondary hypothesis was that MRgLITT has fewer complications and shorter hospitalization than surgery. The primary objective was to compare seizure outcome of MRgLITT to open surgery in children with DRE. The secondary objective was to compare complications and length of hospitalization of the two treatments. Methods: This retrospective multicenter cohort study included children with DRE treated with MRgLITT or open surgery with 1-year follow-up. Exclusion criteria were corpus callosotomy, neurostimulation, multilobar or hemispheric surgery, and lesion with maximal dimension > 60 mm. MRgLITT patients were propensity matched to open surgery patients. The primary outcome was seizure freedom at 1 year posttreatment. The difference in seizure freedom was compared using noninferiority test, with noninferiority margin of −10%. The secondary outcomes were complications and length of hospitalization. Results: One hundred eighty-five MRgLITT patients were matched to 185 open surgery patients. Seizure freedom at 1 year follow-up was observed in 89 of 185 (48.1%) MRgLITT and 114 of 185 (61.6%) open surgery patients (difference = −13.5%, one-sided 97.5% confidence interval = −23.8% to ∞, pNoninferiority =.79). The lower confidence interval boundary of −23.8% was below the prespecified noninferiority margin of −10%. Overall complications were lower in MRgLITT compared to open surgery (10.8% vs. 29.2%, respectively, p <.001). Hospitalization was shorter for MRgLITT than open surgery (3.1 ± 2.9 vs. 7.2 ± 6.1 days, p <.001). Significance: Seizure outcome of MRgLITT at 1 year posttreatment was inferior to open surgery. However, MRgLITT has the advantage of better safety profile and shorter hospitalization. The findings will help counsel children and parents on the benefits and risks of MRgLITT and contribute to informed decision-making on treatment options.",

keywords = "drug-resistant epilepsy, laser interstitial thermal therapy, pediatric epilepsy surgery, propensity score, seizure outcome",

author = "Omar Yossofzai and Scellig Stone and Joseph Madsen and Rahim Moineddin and Shelly Wang and John Ragheb and Ismail Mohamed and Robert Bollo and Dave Clarke and Perry, {M. Scott} and Weil, {Alexander G.} and Jeffrey Raskin and Jonathan Pindrik and Raheel Ahmed and Sandi Lam and Aria Fallah and Cassia Maniquis and Andrea Andrade and Ibrahim, {George M.} and James Drake and James Rutka and Jignesh Tailor and Nicholas Mitsakakis and Klajdi Puka and Elysa Widjaja",

note = "Publisher Copyright: {\textcopyright} 2022 International League Against Epilepsy.",

year = "2023",

month = jan,

doi = "10.1111/epi.17451",

language = "English (US)",

volume = "64",

pages = "114--126",

journal = "Epilepsia",

issn = "0013-9580",

publisher = "Wiley-Blackwell Publishing Ltd",

number = "1",

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Yossofzai, O, Stone, S, Madsen, J, Moineddin, R, Wang, S, Ragheb, J, Mohamed, I, Bollo, R, Clarke, D, Perry, MS, Weil, AG, Raskin, J, Pindrik, J, Ahmed, R, Lam, S, Fallah, A, Maniquis, C, Andrade, A, Ibrahim, GM, Drake, J, Rutka, J, Tailor, J, Mitsakakis, N, Puka, K & Widjaja, E 2023, 'Seizure outcome of pediatric magnetic resonance-guided laser interstitial thermal therapy versus open surgery: A matched noninferiority cohort study', Epilepsia, vol. 64, no. 1, pp. 114-126. https://doi.org/10.1111/epi.17451

TY - JOUR

T1 - Seizure outcome of pediatric magnetic resonance-guided laser interstitial thermal therapy versus open surgery

T2 - A matched noninferiority cohort study

AU - Yossofzai, Omar

AU - Stone, Scellig

AU - Madsen, Joseph

AU - Moineddin, Rahim

AU - Wang, Shelly

AU - Ragheb, John

AU - Mohamed, Ismail

AU - Bollo, Robert

AU - Clarke, Dave

AU - Perry, M. Scott

AU - Weil, Alexander G.

AU - Raskin, Jeffrey

AU - Pindrik, Jonathan

AU - Ahmed, Raheel

AU - Lam, Sandi

AU - Fallah, Aria

AU - Maniquis, Cassia

AU - Andrade, Andrea

AU - Ibrahim, George M.

AU - Drake, James

AU - Rutka, James

AU - Tailor, Jignesh

AU - Mitsakakis, Nicholas

AU - Puka, Klajdi

AU - Widjaja, Elysa

PY - 2023/1

Y1 - 2023/1

N2 - Objective: Minimally invasive magnetic resonance-guided laser interstitial thermal therapy (MRgLITT) has been proposed as an alternative to open epilepsy surgery, to address concerns regarding the risk of open surgery. Our primary hypothesis was that seizure freedom at 1 year after MRgLITT is noninferior to open surgery in children with drug-resistant epilepsy (DRE). The secondary hypothesis was that MRgLITT has fewer complications and shorter hospitalization than surgery. The primary objective was to compare seizure outcome of MRgLITT to open surgery in children with DRE. The secondary objective was to compare complications and length of hospitalization of the two treatments. Methods: This retrospective multicenter cohort study included children with DRE treated with MRgLITT or open surgery with 1-year follow-up. Exclusion criteria were corpus callosotomy, neurostimulation, multilobar or hemispheric surgery, and lesion with maximal dimension > 60 mm. MRgLITT patients were propensity matched to open surgery patients. The primary outcome was seizure freedom at 1 year posttreatment. The difference in seizure freedom was compared using noninferiority test, with noninferiority margin of −10%. The secondary outcomes were complications and length of hospitalization. Results: One hundred eighty-five MRgLITT patients were matched to 185 open surgery patients. Seizure freedom at 1 year follow-up was observed in 89 of 185 (48.1%) MRgLITT and 114 of 185 (61.6%) open surgery patients (difference = −13.5%, one-sided 97.5% confidence interval = −23.8% to ∞, pNoninferiority =.79). The lower confidence interval boundary of −23.8% was below the prespecified noninferiority margin of −10%. Overall complications were lower in MRgLITT compared to open surgery (10.8% vs. 29.2%, respectively, p <.001). Hospitalization was shorter for MRgLITT than open surgery (3.1 ± 2.9 vs. 7.2 ± 6.1 days, p <.001). Significance: Seizure outcome of MRgLITT at 1 year posttreatment was inferior to open surgery. However, MRgLITT has the advantage of better safety profile and shorter hospitalization. The findings will help counsel children and parents on the benefits and risks of MRgLITT and contribute to informed decision-making on treatment options.

AB - Objective: Minimally invasive magnetic resonance-guided laser interstitial thermal therapy (MRgLITT) has been proposed as an alternative to open epilepsy surgery, to address concerns regarding the risk of open surgery. Our primary hypothesis was that seizure freedom at 1 year after MRgLITT is noninferior to open surgery in children with drug-resistant epilepsy (DRE). The secondary hypothesis was that MRgLITT has fewer complications and shorter hospitalization than surgery. The primary objective was to compare seizure outcome of MRgLITT to open surgery in children with DRE. The secondary objective was to compare complications and length of hospitalization of the two treatments. Methods: This retrospective multicenter cohort study included children with DRE treated with MRgLITT or open surgery with 1-year follow-up. Exclusion criteria were corpus callosotomy, neurostimulation, multilobar or hemispheric surgery, and lesion with maximal dimension > 60 mm. MRgLITT patients were propensity matched to open surgery patients. The primary outcome was seizure freedom at 1 year posttreatment. The difference in seizure freedom was compared using noninferiority test, with noninferiority margin of −10%. The secondary outcomes were complications and length of hospitalization. Results: One hundred eighty-five MRgLITT patients were matched to 185 open surgery patients. Seizure freedom at 1 year follow-up was observed in 89 of 185 (48.1%) MRgLITT and 114 of 185 (61.6%) open surgery patients (difference = −13.5%, one-sided 97.5% confidence interval = −23.8% to ∞, pNoninferiority =.79). The lower confidence interval boundary of −23.8% was below the prespecified noninferiority margin of −10%. Overall complications were lower in MRgLITT compared to open surgery (10.8% vs. 29.2%, respectively, p <.001). Hospitalization was shorter for MRgLITT than open surgery (3.1 ± 2.9 vs. 7.2 ± 6.1 days, p <.001). Significance: Seizure outcome of MRgLITT at 1 year posttreatment was inferior to open surgery. However, MRgLITT has the advantage of better safety profile and shorter hospitalization. The findings will help counsel children and parents on the benefits and risks of MRgLITT and contribute to informed decision-making on treatment options.

KW - drug-resistant epilepsy

KW - laser interstitial thermal therapy

KW - pediatric epilepsy surgery

KW - propensity score

KW - seizure outcome

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Seizure outcome of pediatric magnetic resonance-guided laser interstitial thermal therapy versus open surgery: A matched noninferiority cohort study

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