Original Title: Seguridad y efectividad de la terapia térmica inducida por láser en pacientes con epilepsia refractaria. Revisión sistemática

Authors' objectives: To evaluate the safety and effectiveness of MRgLITT in patients with epilepsy refractory to medical treatment.

Authors' results and conclusions: Fourteen non-comparative intervention trials were identified (9 of them with prospective design) that included a total of 266 patients. The pooled postoperative complication rate was 26% and the most frequent complications were visual field defects, headache, bruising or haemorrhage, and cranial nerve abnormalities. Procedure-related adverse events were rare (2.9% of the total) and 9.8% of the patients required a new surgical intervention after treatment with MRgLITT. Two studies reported the total absence of deaths and one of them notified a suicide death. Regarding the effectiveness of MRgLITT, the pooled rate of patients with good results in seizure control (Engel Class I and/or free of disabling seizures) after more than one year of ablation with MRgLITT was 57%, and 19% for a reduction in seizure frequency (i.e., sporadic disabling seizures, virtually no seizures, or Engel Class 2) and 20% for significant improvement in seizure frequency (Engel Class 3). The pooled rate for Engel Class 4 (i.e., no significant improvement in seizure frequency reduction) was 18% and the mean time to first seizure after RMgLITT treatment was 5.1 months. The 8.3% of the patients achieved total antiepileptic drug withdrawal and the 51.8% of patients showed a reduction in the number of medications or the dose of any of them. The mean time of hospitalization for patients treated with MRgLITT was 1.6 days. No study analyzed the quality of life of patients with refractory epilepsy who underwent MRgLITT. The certainty of the evidence for the key outcomes is very low, and future development of prospective, multicenter studies, with larger cohorts and longer follow-up periods, is imperative.

Authors' methods: To identify relevant studies, specific search strategies were developed and the following electronic databases were consulted: Ovid MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials, Center for Reviews and Dissemination (CRD) Database, and the Web of knowledge (WOS), among other databases. Studies (randomized or not) analyzing the effect of MRgLITT using standard equipment in patients (adults or children) with a diagnosis of epilepsy refractory to medical treatment were included. Two independent reviewers carried out study selection and relevant data extraction, while assessing risk of bias using the MINORS tool. A quantitative synthesis of the evidence was developed for complications and seizure control outcomes (classified as Engel 1,2 and 3), while the analysis of other outcome variables such as the need for reinterventions, mortality, changes in seizure frequency, seizure-free time, and quality of life or others were qualitatively analyzed. In addition, statistical heterogeneity was estimated and the GradePro tool was used to assess the quality of the evidence.

Project Status: Completed

URL for project: https://www.aetsa.org/publicacion/seguridad-y-efectividad-de-la-terapia-termica-inducida-por-laser-con-epilepsia-refractaria/

Year Published: 2021

URL for published report: https://www.aetsa.org/download/01_2019_AETSA_Laser-en-epilepsia_DEF_NIPO.pdf

Requestor: Spanish Health Ministry

English language abstract: An English language summary is available

Publication Type: Full HTA

Country: Spain

Organisation Name: Andalusian Health Technology Assessment Area

Contact Address: Area de Evaluacion de Tecnologias Sanitarias Sanitarias de Andalucia (AETSA) Avda. Innovación, s/n Edificio Arena 1. Sevilla (Spain) Tel. +34 955 006 309

Contact Name: aetsa.csalud@juntadeandalucia.es

Contact Email: aetsa.csalud@juntadeandalucia.es

Copyright: Andalusian Agency for Health Technology Assessment (AETSA)