Authors :
Presenting Author: Robert Gross, MD, PhD – Rutgers Robert Wood Johnson Medical School, New Brunswick, New Jersey, USA; Rutgers New Jersey Medical School, New Brunswick, New Jersey, USA.
Author: Daniel Drane, PhD – Emory University
Guy McKhann, MD – Columbia University Irving Medical Center
Vicenta Salanova, MD – Indiana University, School of Medicine, Indianapolis, Indiana, USA.
Jamie Van Gompel, MD – Mayo Clinic
Jonathan Jagid, MD – Jackson Memorial Hospital, University of Miami, Miami, Florida, USA.
Brian Cabaniss, MD – Emory University School of Medicine, Atlanta, Georgia, USA.
Nitin Tandon, MD – University of Texas Health Science Center, School of Public Health, Houston, Texas, USA.
Robert Knowlton, MD – Weill Institute for Neurosciences, School of Medicine, University of California San Francisco (UCSF), San Francisco, California, U.S.A.
Kristie Wallace, MS – Medtronic, Minneapolis, Minnesota, USA.
Alejandra Gracia, BA – Medtronic, Minneapolis, Minnesota, USA.
Ashwini Sharan, MD – Thomas Jefferson University, Philadelphia, Pennsylvania, USA; Medtronic, Minneapolis, Minnesota, USA.
Jonathon Giftakis, PhD – Medtronic, Minneapolis, Minnesota, USA.
Michael Sperling, MD – Thomas Jefferson University, Philadelphia, Pennsylvania, USA.
Rationale:
This is the first large prospective study to investigate the role of stereotactic laser ablation (SLA) in mesial temporal lobe epilepsy (MTLE). SLA is increasingly being used as an alternative to open resective procedures. Retrospective studies evaluating the clinical benefits of SLA for MTLE have been promising, demonstrating slightly lower seizure freedom rates but with fewer side effects and improved patient recovery. The SLATE study further evaluated the safety and efficacy of the VisualaseTM System in subjects with MTLE due to mesial temporal sclerosis (MTS).Methods:
Prospective, single-arm, observational, multicenter study, with outcomes compared against known effects of anterior temporal lobectomy (ATL).1 Pre-surgical evaluation consisted of a central review of each subject’s epilepsy history, MRI, EEG and any additional testing results available (e.g., PET, SPECT, invasive EEG or MEG) to confirm study qualification for treatment of their MTLE. Eligible subjects underwent unilateral MRI-guided SLA of their amygdala and hippocampus with the VisualaseTM System and were followed for 12 months.Results:
In the study, 167 subjects were enrolled across 21 sites in the United States, with 114 subjects treated and followed for 12 months post procedure. 107 subjects successfully completed the study. One subject was retreated in the study between 3 and 6 months. The average age was 44.2 ± 13.9 years (58.8% female). The average years from epilepsy diagnosis was 24.0 ± 17.2 years, and the average monthly seizure frequency of all seizure types over the 12 months prior to enrollment was 11.5 ± 15.4 seizures. Five subjects (4.4%) had a VNS stimulator. Seventy-four patients (64.9%) had left sided SLA.
At 12 months, 55.9% (95% LCI: 45.9%) of subjects had an Engel I outcome (primary efficacy endpoint). The incidence of qualifying device, procedure, or anesthesia related adverse events (AEs) through 12 months was 10 events in 9 treated subjects (7.9%) (95% UCI: 14.5%) and included the following: postoperative wound infection (1), soft tissue infection (1), upper respiratory tract infection (1), cognitive disorder (1), headache (3), partial seizures with secondary generalization (1), quadrantanopia (1) and confusional state (1). The observed rates for efficacy and safety met study expectations.1 The average change from baseline in the QOLIE-31 overall score was 9.4 ± 9.8, with 38 (40.9%) subjects experiencing a clinically significant increase (≥ 11.8, p-value: < 0.0001). Greatest improvement in quality of life (QOL) was in seizure free subjects (fig 1). No deaths or unanticipated adverse events were observed.Conclusions:
The rate of seizure freedom at 1 year following the VisualaseTM procedure is consistent with prior studies evaluating SLA in patients with MTS. Notable clinical improvements in QOL were observed with no reports of SUDEP. The results from the SLATE study suggest that SLA is an effective and well-tolerated therapy that may be used in place of open resective procedures for MTLE.
1. Sperling MR, Gross RE, et al. Stereotactic Laser Ablation for Mesial Temporal Lobe Epilepsy: A prospective, multicenter, single-arm study. Epilepsia. 2020;61:1183-1189.Funding: Study funded by Medtronic.