| Coverage Policy Manual | |
| Policy #: | 2012065 |
| Category: | Surgery |
| Initiated: | November 2012 |
| Last Review: | January 2024 |
|
|
|
|||||||||||
| Laser Interstitial Thermal Therapy for Neurological Conditions | |
|
|
|
| Description: |
Laser interstitial thermal therapy (LITT) involves the introduction of a laser fiber probe to deliver thermal energy for the targeted ablation of diseased tissue. Thermal destruction of tissue is mediated via DNA damage, necrosis, protein denaturation, membrane dissolution, vessel sclerosis, and coagulative necrosis (Lagman, 2017). The goal of therapy is selective thermal injury through the maintenance of a sharp thermal border, as monitored via the parallel use of real-time magnetic resonance (MR) thermography and controlled with the use of actively cooled applicators (Medvid, 2015). In neurological applications, LITT involves the creation of a transcranial burr hole for the placement of the laser probe at the target brain tissue. Probe position, ablation time, and intensity are controlled under MRI guidance.
The majority of neurological LITT indications described in the literature involve the ablation of primary and metastatic brain tumors, epileptogenic foci, and radiation necrosis in surgically inaccessible or eloquent brain areas (Medvid, 2015). LITT may offer a minimally invasive treatment option for patients with a high risk of morbidity with traditional surgical approaches. The most common complications following LITT are transient and permanent weakness, cerebral edema, hemorrhage, seizures, and hyponatremia (Holste, 2020). Delayed neurological deficits due to brain edema are temporary and typically resolve after corticosteroid therapy. Contraindications to MRI are also applicable to the administration of LITT.
Regulatory Status
In August 2007, the Visualase™ Thermal Therapy System (Medtronic; formerly Biotex, Inc.) received initial marketing clearance by the FDA through the 510(k) pathway (K071328). As of March 2019, the system is indicated for use “to necrotize or coagulate soft tissue through interstitial irradiation or thermal therapy under magnetic resonance imaging (MRI) guidance in medicine and surgery in cardiovascular thoracic surgery (excluding the heart and vessels in the pericardial sac), dermatology, ear-nose-throat surgery, gastroenterology, general surgery, gynecology, head and neck surgery, neurosurgery, plastic surgery, orthopedics, pulmonology, radiology, and urology, for wavelengths 800 nm through 1064 nm” (K181859). Data from compatible MRI sequences can be processed via proton resonance-frequency shift analysis and image subtraction to relate imaging changes to relative changes in tissue temperature during therapy. The Visualase™ cooling applicator utilizes saline.
In April 2013, the NeuroBlate® System (Monteris Medical) received initial clearance for marketing by the FDA through the 510(k) pathway (K120561). As of August 2020, the system is indicated for use “to ablate, necrotize, or coagulate intracranial soft tissue, including brain structures (eg, brain tumor and epileptic foci as identified by non-invasive and invasive neurodiagnostic testing, including imaging), through interstitial irradiation or thermal therapy in medicine and surgery in the discipline of neurosurgery with 1064 nm lasers” (K201056). The device is intended for planning and monitoring of thermal therapy under MRI guidance, providing real-time thermographic analysis of selected MRI images. The NeuroBlate® system utilizes a laser probe with a sapphire capsule to promote prolonged, pulsed laser firing and a controlled cooling applicator employing pressurized CO2.
On April 25, 2018, the FDA issued a safety alert on MR-guided LITT (MRgLITT) devices with a letter to healthcare providers stating that the FDA is currently evaluating data suggesting that potentially inaccurate MR thermometry information can be displayed during treatment, which may contribute to a risk of tissue overheating and potentially associated adverse events, including neurological deficits, increased intracerebral edema or pressure, intracranial bleeding, and/or visual changes (FDA, 2018). Several risk mitigation strategies were recommended. In an updated letter released on November 8, 2018, risk mitigation recommendations specific to the Visualase™ and NeuroBlate® systems were issued (FDA, 2018).
|
|
|
|
|
Policy/ Coverage: |
Effective January 2022
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
Laser interstitial thermal therapy meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes for the following indications when all criteria is met:
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
The use of laser interstitial thermal therapy for all other conditions, neurological or non-neurological, does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness and are not covered, including but not limited to:
For members with contracts without primary coverage criteria, the use of laser interstitial thermal therapy for all other conditions, neurological or non-neurological, is considered investigational, including but not limited to:
Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Effective Prior to January 2022
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
Laser interstitial thermal therapy for treatment of primary, recurrent, or metastatic tumors of the brain does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
For members with contracts without primary coverage criteria, the use of laser interstitial thermal therapy for treatment of primary, recurrent, or metastatic tumors of the brain is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
|
|
|
|
| Rationale: |
Carpentier and colleagues reported the final results of a two pilot clinical trials (2008 and 2011) exploring the safety and feasibility of real-time magnetic resonance-guided laser-induced thermal therapy (MRgLITT) for treatment of resistant focal metastatic intracranial tumors. In the first study four patients (six metastatic tumors) were treated. Follow-up was performed at 7, 15, 30, and 90 days after treatment. No tumor recurrence within thermal ablation zones was noted.
In the second study (NCT00392119), seven patients (15 tumors) with chemotherapy, whole-brain radiation, and radiosurgery resistant metastatic intracranial tumors, were treated. Follow-up imaging at up to 30 months was done. No tumor recurrence within thermal ablation zones was noted. Kaplan-Meier analysis indicated that the median survival was 19.8 months. MR-guided LITT allows a minimally invasive option for destruction and treatment of resistant focal metastatic intracranial tumors and appears to provide a safe and potentially effective treatment for recurrent focal metastatic brain disease. Larger phase II and III studies are needed to determine the potential advantages of MR-guided LITT.
Carpentier and colleagues (2012) reported on four patients with recurrence of glioblastoma (age range 40 – 58 years) after total resection, chemotherapy and radiation therapy. None were eligible for a second surgery, so Laser-induced thermal therapy (LITT) was proposed as salvage therapy. LITT, coupled with magnetic resonance thermal imaging (MRTI) guidance, was performed. Real-time feedback control based on MRTI was employed to assess the quality of local tissue destruction and to prevent unwanted damage to nearby structures. Post-procedure MRI showed no complication and a decrease in size of the treated tumor. For all patients, recurrence was observed with a mean/median progression free survival of 37/30 days. Mean/median overall survival after LITT was 10.5/10 months. Larger studies will be necessary to define indications and accurately determine a potentially significant survival gain. LITT could be considered as salvage therapy for high-grade recurrent gliomas if a 1-day treatment is considered useful for a few weeks gain in survival.
Hawasli and colleagues (2012) at Washington Universtiy reported on a technical case of a 61-year-old right-handed man with a history of metastatic adenocarcinoma of the colon. He had previously undergone resection of multiple lesions, Gamma Knife radiosurgery, and whole-brain radiation. The left insular tumor continued to enlarge after treatment. Due to the location and refractory nature of the tumor, the patient elected to undergo LITT treatment. The AXiiiS Stereotactic Miniframe (Monteris Medical) for the LITT system was used to perform the procedure. Satisfactory tumor ablation was accomplished with the procedure. The authors concluded that LITT with intraoperative MRI and stereotactic image guidance is a newly available, minimally invasive, and therapeutically viable technique for the treatment of deep seated brain tumors. Recurrence or length of survival were not reported for the patient.
A search on www.clinicaltrials.gov identified the following studies for LITT for treatment of brain tumors:
2013 Update
A search of the MEDLINE database through October 2013 did not reveal any new literature that would prompt a change in the coverage statement. Results of a Phase I trial (NCT00747253) discussed in the rationale above were published in 2013 (Sloan, 2013). The main goal of the study was to evaluate the relationship between thermal dose, toxicity, and clinical efficacy. Adult patients (n=10) with recurrent or progressive glioblastoma multiforme in whom standard therapy (radiotherapy with or without chemotherapy) had failed. Three patients improved neurologically, 6 remained stable and 1 worsened. The median survival was 316 days. The authors report, “The favorable survival results may be due in part to selection bias because the entry criteria required patients with unifocal tumors 1–4 cm in maximum diameter” (Slaon, 2013). Two patients had serious neurological adverse events due to the NeuroBlate procedure, both at the highest dose level. One patient suffered a small intracerebral hemorrhage due to an arterial pseudoaneurysm 6 weeks after treatment. The other patient experienced severe hemiparesis on awakening but regained significant function in 6–8 weeks. Limitations as outlined in an accompanying editorial include: cerebrovascular complications; this is a focal treatment and GBM is an invasive disease; and since expenses for new technologies are under scrutiny regarding outcomes there may be a burden for LITT to show superior outcomes to other focal technologies (Elder, 2013). Larger, randomized, comparative trials are needed to show improved outcomes with this technology.
The following trials are ongoing (www.clinicaltrials.org):
2014 Update
A literature search conducted using the MEDLINE database through October 2014 did not reveal any new information that would prompt a change in the coverage statement.
2015 Update
A literature search conducted through October 2015 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
A multicenter study by Mohammadi and colleagues has shown surgical extent-of-resection to have an impact on high-grade glioma (HGG) outcomes; however, complete resection is rarely achievable in difficult-to-access (DTA) tumors (Mohammadi, 2014). Controlled thermal damage to the tumor may have the same impact in DTA-HGGs. We report our multicenter results of laser interstitial thermal therapy (LITT) in DTA-HGGs. We retrospectively reviewed 34 consecutive DTA-HGG patients (24 glioblastoma, 10 anaplastic) who underwent LITT at Cleveland Clinic, Washington University, and Wake Forest University (May 2011-December 2012) using the NeuroBlate(®) System. The extent of thermal damage was determined using thermal damage threshold (TDT) lines: yellow TDT line (43 °C for 2 min) and blue TDT line (43°C for 10 min). Volumetric analysis was performed to determine the extent-of-coverage of tumor volume by TDT lines. Patient outcomes were evaluated statistically. LITT was delivered as upfront in 19 and delivered as salvage in 16 cases. After 7.2 months of follow-up, 71% of cases demonstrated progression and 34% died. The median overall survival (OS) for the cohort was not reached; however, the 1-year estimate of OS was 68 ± 9%. Median progression-free survival (PFS) was 5.1 months. Thirteen cases who met the following two criteria-(1) <0.05 cm (3) tumor volume not covered by the yellow TDT line and (2) <1.5 cm(3) additional tumor volume not covered by the blue TDT line-had better PFS than the other 21 cases (9.7 vs. 4.6 months; P = 0.02). LITT can be used effectively for treatment of DTA-HGGs. More complete coverage of tumor by TDT lines improves PFS which can be translated as the extent of resection concept for surgery.
2017 Update
A literature search conducted using the MEDLINE database through October 2017 did not reveal any new information that would prompt a change in the coverage statement.
2018 Update
A literature search was conducted through October 2018. There was no new information identified that would prompt a change in the coverage statement.
2019 Update
Annual policy review completed with a literature search using the MEDLINE database through October 2019. No new literature was identified that would prompt a change in the coverage statement.
2020 Update
Annual policy review completed with a literature search using the MEDLINE database through October 2020. No new literature was identified that would prompt a change in the coverage statement.
2021 Update
Annual policy review completed with a literature search using the MEDLINE database through October 2021. No new literature was identified that would prompt a change in the coverage statement.
2022 Update
Annual policy review completed with a literature search using the MEDLINE database through October 2022. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
Chen et al published a systematic review and meta-analysis of retrospective studies and case series investigating the efficacy of LITT for brain metastases with in-field recurrence or radiation necrosis following treatment with SRS (Chen, 2021). A meta-analysis of 14 studies (470 patients with 542 lesions) was performed. The overall 12-month local control rate ranged between 56.0% and 84.7% with a pooled rate of 69.0% (95% CI, 60.0% to 76.7%; I2 = 50.584%; p=.048) and pooled OS of 17.15 months (95% CI, 13.27 to 24.8). Among 153 recurrent brain metastatic lesions across 5 studies, the 12-month local control rate was 59.9% (95% CI, 47.9% to 70.9%). Among 75 radiation necrosis lesions across 4 studies, the 12-month local control rate was 76.3% (95% CI, 65.0% to 84.8%). Thus, LITT provided more favorable local control efficacy in patients with radiation necrosis compared to those with brain metastasis recurrence. No significant difference in median OS at 1 year was determined between the radiation necrosis and brain metastasis groups (66.5% vs. 66.8%; p=.978). Survival outcomes were not stratified by pathology and safety outcomes were not reported. Compared to previously reported estimates for surgical resection with a local control rate ranging from 62% to 93% and a median OS of 8.7 months, the authors concluded that LITT demonstrates comparable local control but a more satisfactory survival benefit. The analysis is limited by study heterogeneity, small sample sizes, and the lack of a standardized definition for local disease control.
de Franca et al published a systematic review and meta-analysis of LITT as a therapy for brain tumors compared to SRS based on 25 studies (de Franca, 2020). Patient populations included patients with brain metastasis and recurrent glioblastoma multiforme (rGBM). A significant improvement in median OS was observed in patients treated with LITT compared to SRS among patients with brain metastasis (12.8 vs. 9.8 mo; p<.02) and was associated with a 15% reduction in risk of adverse events overall. The authors concluded that "there is no evidence that LITT can be used as a treatment of choice when compared to SRS," but use of LITT may have a role in lowering the risk of adverse events. The analysis was limited by inclusion of heterogeneous populations, the small number of patients treated with LITT (n=39), and a lack of reporting on prior treatments. In particular, patients treated with SRS varied in their degree of radiosensitivity and prior radiation exposure, which may have influenced the higher rate of adverse events observed in this group.
Barnett et al conducted a systematic review and meta-analysis comparing LITT (8 studies; 77 patients) to open craniotomy (12 studies; 1036 patients) for the treatment of high-grade gliomas in or near areas of eloquence, with a focus on adverse events (Barnett, 2016). Proportions of major complications occurred in 5.7% (95% CI: 1.8 to 11.6) and 13.8% (95% CI: 10.3 to 17.9) of patients treated via LITT and craniotomy, respectively. Studies were rated at high risk of bias due to lack of randomization and blinding. The analysis was also limited by heterogeneous patient populations (e.g., age, Karnofsky score, recurrent vs. primary disease) and lack of reporting on health outcomes.
Mohammadi et al conducted a multicenter retrospective review of survival outcomes in patients with deep seated newly diagnosed glioblastoma treated with upfront MR-guided LITT prior to chemo/radiotherapy (n=24; median age, 54 y; 50% male; 71% <70 yr) compared to a matched cohort of biopsy-only patients (n=24; median age, 64 yr; 58% male; 75% <70 yr) (Mohammadi, 2019). Patients were matched based on age, gender, tumor location (deep vs. lobar), and tumor volume. Median follow-up was 9.3 mo (range, 2 to 43 mo) and 14.7 mo (range, 2 to 41 mo) in LITT and biopsy-only cohorts, respectively. Overall median estimates of OS and progression-free survival in the LITT cohort was 14.4 and 4.3 mo compared to 15.8 and 5.9 mo for the biopsy-only cohort. Age <70 y and tumor volume <11 cm3 were identified as favorable prognostic factors for OS. The study was limited by its retrospective design, lack of randomization, small sample size, and short follow-up durations. Additionally, concurrent chemotherapy and radiotherapy regimens were not specified.
The Laser Ablation of Abnormal Neurological Tissue Using Robotic NeuroBlate System (LAANTERN) registry is an ongoing industry-sponsored, multicenter, multinational prospective registry of the NeuroBlate device enrolling patients with primary and metastatic brain tumors, epileptic foci, and movement disorders (NCT02392078). Rennert et al reported procedural safety outcomes for the first 100 patients enrolled in the LAANTERN registry (42% male, 86% white), including 48 and 34 patients with primary or metastatic intracranial tumors, respectively (Rennert, 2020). The majority of patients (81.2%) had undergone prior surgical or radiation treatment and received LITT for a single lesion (79%). The average length of intensive care and overall hospital stays were 38.1 and 61.1 hours, respectively. A total of 11 adverse events among 9 patients were observed. Five adverse events were attributed to energy deposition from laser ablation, including neurological deficits (n=2), postoperative seizures (n=2), and delayed intraparenchymal hemorrhage (n=1). One mortality occurring within 30 days of laser ablation was reported and was not attributed to LITT.
Kim et al reported 12-month survival and quality of life outcomes among 223 patients enrolled in the LAANTERN registry with primary (n=131) or metastatic (n=92) brain tumors who received treatment with the NeuroBlate device (Kim, 2020). The majority of patents with primary tumors had high-grade glioma (n=90) and patients with metastatic disease had recurrent tumors (n=43) or radionecrosis (n=34). The 1-yr estimated OS rate was 73% (95% CI, 65.3% to 79.2%), which was not found to be significantly different between primary or metastatic tumors (74.6% vs. 70.7%, respectively). Quality of life assessments with the Functional Assessment of Cancer Therapy - Brain (FACT-Br) questionnaire did not meet the criteria for a clinically meaningful change (>10%) and EQ-5D questionnaires indicated an overall decline of 0.1 points from baseline.
Ahluwalia et al reported results from the multicenter, prospective Laser Ablation After Stereotactic Radiosurgery (LAASR) study, which assessed the efficacy and safety of LITT as salvage treatment in patients with radiographic progression after SRS for brain metastasis (Ahluwalia, 2018). Forty-two patients were enrolled, including 20 patients with recurrent brain tumors, 19 patients with biopsy-proven radiation necrosis, and 3 patients with no diagnosis. Progression-free survival rates for patients with recurrent tumors was 54% at 12 weeks and 62% at 26 weeks. Corresponding OS rates were 71% at 12 weeks and 64.5% at 26 weeks. Of 4 tumor lesions that received total ablation, 3/4 achieved a complete response, compared to 0/8 that received subtotal ablation. Patient Karnofsky performance, quality of life, and neurocognitive scores did not change significantly over the duration of survival. Overall, 35/42 (83%) patients developed adverse events, including 5 cases of immediate LITT-related neurological complications and 14 surgery-related adverse events.
Patel et al conducted a retrospective analysis of patients who underwent MR-guided LITT with the Visualase system at a single center in the United States between 2010 and 2014 (Patel, 2016). The majority of patients (87/102) were treated for intracranial tumors. Fourteen (13.7%) developed new neurological deficits following treatment, of which 9 achieved complete resolution within 1 month, 1 achieved partial resolution within 1 month, 2 had no resolution at most recent follow-up, and 2 died without resolution of symptoms. The authors concluded that LITT, albeit minimally invasive, must be used with caution as unintended thermal damage to critical and eloquent structures may occur despite MRI guidance.
Sujijantarat et al conducted a retrospective chart review comparing outcomes for patients with biopsy-confirmed radiation necrosis treated with LITT (n=25) or bevacizumab (n=13) at a single center between 2011 and 2018 (Sujijantarat, 2020). The LITT group had a significantly longer OS compared to bevacizumab (median 24.8 vs. 15.2 months; p=.003). Time to local recurrence was not statistically significant between groups (p=.091) but trended longer in the LITT cohort. Among 13 patients with pre-treatment symptoms in the LITT group, 9 (69%) achieved symptom relief. Among 11 patients with pre-treatment symptoms in the bevacizumab group, 4 (36%) achieved symptom relief. No significant difference was noted between groups for the ability to wean off concurrent steroids. Given that only 50% of lesions treated with LITT were symptomatic compared to 80% of lesions treated with bevacizumab, the authors suggest that LITT treatment may be more successful before radiation necrosis lesions become symptomatic. The study is limited by its retrospective design, small samples size, and population heterogeneity.
Hong et al conducted a single-center retrospective chart review of patients treated with LITT or craniotomy for previously irradiated brain metastasis, including 42 patients with recurrent brain tumors and 33 patients with radiation necrosis (Hong, 2019). Among the 33 radiation necrosis patients, 15 received craniotomy and 18 received LITT, of which 20% and 38.9% received adjuvant post-operative bevacizumab, respectively. No significant differences for mean length of hospital stay, symptom improvement, ability to wean off steroids, or rate of perioperative complications were observed between LITT and craniotomy groups. Overall progression-free survival for patients with radiation necrosis was 73.2% and 86.7% at 24 months for patients treated with LITT and craniotomy, respectively. Overall survival for patients with radiation necrosis at 24 months was 64.6% for those receiving craniotomy and 63.2% for those receiving LITT. Study interpretation is limited by its retrospective nature and heterogeneity of prior and adjuvant treatments.
The LAASR study, described previously, included 19 patients with biopsy-confirmed radiation necrosis who received LITT following prior treatment with SRS for brain tumors (Ahluwalia, 2018). Progression-free survival and OS were 100% and 91%, respectively, at 12 weeks, and 100% and 82.1%, respectively, at 26 weeks. Progression-free survival was significantly higher at 12 weeks for patients with radiation necrosis compared to patients with recurrent tumors (p=.016) but was not significantly different at 12 weeks (p=.166). Similar trends were seen for OS in patients with radiation necrosis at 12 weeks (p=.02) and 26 weeks (p=.09). Thirty percent of subjects were able to stop or reduce steroid usage by 12 weeks after surgery. For patients with radiation necrosis, regardless of whether a lesion was totally or subtotally ablated, LITT resulted in close to 100% lesion control and >80% survival at 6 months. No significant differences in Karnofsky performance status, quality of life, or neurocognitive scores were detected between subgroups.
Kohlhase et al performed a systematic review and meta-analysis to compare outcomes and complications from MR-guided LITT, radiofrequency ablation (RFA), and conventional open surgery (i.e., anterior temporal lobe resection [ATL] or selective amygdalohippocampectomy [sAHE]) in patients with drug-refractory mesial temporal lobe epilepsy (mTLE) (Kohlase, 2021). Forty-three studies were identified (13 LITT; 6 RFA; 24 conventional surgery) between 1995 and 2018. Meta-analytic estimates for the proportion of patients achieving Engel I outcomes were 34% (95% CI, 15% to 61%), 57% (95% CI, 53% to 61%), 65% (95% CI, 58% to 72%) and 69% (95% CI, 62% to 75%) for RFA, LITT, sAHE, and ATL, respectively. No significant difference in outcome was noted between LITT and RFA (p=.098), whereas significantly better outcomes were observed following conventional surgery with both sAHE (p=.0247) and ATL (p=.0113) compared to LITT. In a subgroup analysis of patients with follow-up duration ≥60 months, both ATL (p=.009) and sAHE (p=.043) resulted in significantly higher rates of Engel I outcomes compared to LITT. Among patients treated with LITT, significantly better outcomes were observed in patients with mTLE and hippocampal sclerosis (p=.0035). Overall complication rates were 14.1%, 17.5%, 31.3%, and 18.2% for LITT, RFA, ATL, and sAHE, respectively, with corresponding major complication rates of 3.8%, 3.7%, 10.9%, and 7.4%. However, meta-analysis revealed no significant differences concerning overall and major complication rates between procedures. The authors concluded that overall, patients treated with MR-guided LITT had a lower chance of achieving an Engel I outcome compared to those who received conventional surgery and that the presence of mesial hippocampal sclerosis might be a prognostic factor for a more favorable outcome with LITT.
Brotis et al conducted a meta-analysis to estimate the efficacy of LITT for mTLE (Brotis, 2021). Sixteen retrospective case series published between 2012 and 2019 representing 575 patients (range, 1 to 231) were identified. Overall, seizure freedom was achieved in 54.7% (95% CI, 50.6% to 58.8%; I2=18.7%) of patients undergoing LITT with a median follow-up duration of 18 months (interquartile range [IQR], 12 to 26 months). Sensitivity analyses yielded similar results. Four studies representing 150 patients indicated that the prevalence of Engel Class IA outcomes decreased with time, estimated at 64.2%, 46.9%, and 42.4% at 12-, 24-, and 36-month follow-up, respectively. The overall quality of evidence was regarded as 'very low' according to GRADE recommendations, with only 4 studies including more than 20 patients. The authors concluded that while mTLE resective surgeries are invasive and irreversible, they offer better seizure control rates, with previously reported seizure-free rates ranging from ranging from 60% to 90% for mTLE.
Grewal et al published a systematic review and meta-analysis comparing MR-guided LITT versus SRS for medically intractable temporal lobe epilepsy (TLE) (Grewal, 2019). A total of 19 studies published between 2008 and 2018 representing 404 patients (range, 5 to 58) were identified, including 9 retrospective studies on LITT (n=239). The overall seizure freedom rate was not found to be significantly different between LITT (50%; 95% CI, 44% to 56%) and SRS (42%; 95% CI, 27% to 59%; p=.39), nor was it significantly different for patients with lesional conditions (62% [95% CI, 48% to 74%] vs. 50% [95% CI, 37% to 64%]; p=.23). While LITT was associated with a significantly lower procedural complication rate (20% vs. 26%; p=.06), reoperation rates were not significantly different (15% vs. 27%; p=.31). The authors noted that the quality of evidence was low and that large-scale studies directly comparing LITT and SRS are required to validate findings.
Xue et al reported postoperative outcomes for MR-guided LITT in the treatment of drug-resistant epilepsy (Xue, 2018). Sixteen nonrandomized studies published between 2014 and 2018 representing 269 patients (range, 5 to 30) were included in the meta-analysis. The prevalence of Engel Class I, II, III, and IV outcomes was 61%, 12%, 16%, and 15%, respectively. The prevalence of postoperative complications was 24% (95% CI, 16% to 32%). Interpretation of outcomes is limited by small study size and short follow-up durations (range, 7 days to 51 months).
Hoppe and Helmstaedter reported postoperative outcomes for pediatric patients <18 years treated with LITT for drug-resistant epilepsy (Hoppe, 2018). Twenty-five case series representing 179 patients were included in the review, with the majority of cases attributed to hypothalamic hamartomas (64.2%). Among published cases, the overall complication rate was 23.5% with a 3.4% rate of severe complications. Engel I seizure-free outcomes were achieved by 57.5% of patients across studies, including individuals with short follow-up (e.g., 1 month) and repeat treatments. No studies reported on cognitive outcomes on the basis of standardized psychometric measures. Overall, the authors concluded that the published evidence does not yet allow a scientific or clinical judgement on the utility of LITT for pediatric epilepsy surgery.
Hale et al reported postsurgical outcomes in 26 pediatric patients with insular epilepsy treated with LITT (n=14) or open resection (n=12) (Hale, 2019). Mean follow-up was 2.43 years. Engel Class I outcomes were achieved in 43% of patients treated with LITT compared to 50% who underwent open insular resection at 1 year post-surgery. Postoperative complications occurred in 6 patients treated with LITT and 7 patients treated with resection, all of which resolved within 3 to 4 months. The authors concluded that further studies are needed to determine the noninferiority of LITT with respect to resection in terms of complication rates and seizure freedom, especially in cases of cortical dysplasia that may involve extensive regions of the brain.
Petito et al published a retrospective, single center analysis of 100 consecutive neurosurgeries performed between 2013 and 2015 in patients with drug-resistant epilepsy, representing 33 LITT procedures and 21 open resections with mean follow-up durations of 21.7 and 21.3 months, respectively (Petito, 2018). A discrete lesion was radiographically identified in 85% of patients treated with LITT and 65% of patients treated with resection. The mean post-operative hospital length of stay was significantly shorter for LITT compared to resection (1.18 vs. 3.43 days; p=.0002). Patients treated with resection were significantly younger, with a mean age of 35.4 years (p=.001). At 12 months, seizure freedom was achieved in 56.3% (95% CI, 39.3% to 71.8%) and 60% (95% CI, 38.7% to 78.12%) of patients treated with LITT and resection, respectively (p=0.79). Among patients with focal lesions, the seizure freedom outcomes were not significantly different between groups (p=.21). For nonlesional patients, LITT treatment trended towards a better outcome, but did not achieve statistical significance (p=.05). Study interpretation is limited by the small sample size, retrospective analysis, and population heterogeneity.
Landazuri et al reported 1-year outcomes following LITT of epileptogenic foci with the NeuroBlate system in patients with drug resistant epilepsy enrolled in the previously described LAANTERN registry (Landazurie, 2020; Rennert, 2020). Engel Class I outcomes were achieved in 27/42 (64.3%; 95% CI, 48.0% to 78.5%) patients at 1 year. No significant difference was observed in patients with mesial TLE (70.8%) versus other etiologies. Five adverse events were reported, with 1 categorized as serious. Median baseline QOLIE-31 was 51.7 (range, 8.7 to 77.3). Median scores increased by 14.1 points reflecting a 72.4% improvement (95% CI, 52.8% to 87.3%) in quality of life measures. However, the total score change was not statistically significant (p=.2173). Seizure worry and social functioning sub-scores were considered statistically significant (p=.0219 and p=.0175, respectively). The authors noted that the primary success of LITT remains in well localized lesions/localizations, such as those seen in mesial TLE/mesial temporal sclerosis (MTS), cortical dysplasia, and hypothalamic hamartoma.
Wu et al published the results of a multicenter, retrospective cohort study of 234 patients with drug-resistant mTLE who underwent LITT between 2011 and 2017 (Wu, 2019). At both 1 and 2 years after LITT, 58% of patients achieved Engel I outcomes. Engel I outcomes were associated with ablations involving more anterior, medial, and inferior temporal lobe structures, which tended to involve greater amygdalar volume. Presence or absence of hippocampal sclerosis did not have a significant effect on seizure outcomes. Overall, Engel I or II outcomes were achieved by 76.9% of patients at the time of last follow-up. A total of 42 complications were observed in 35 patients, of which 34 persisted at last follow-up.
In September 2021, the American Association of Neurological Surgeons (AANS) and Congress of Neurological Surgeons (CNS) Joint Section on Tumors issued a position statement regarding the use of LITT for brain tumors and radiation necrosis (Barnett, 2021). The statement concludes that "LITT is an appealing option because it offers a method of minimally invasive, targeted thermal ablation of a lesion with minimal damage to healthy tissue. There is a growing body of evidence to demonstrate that LITT is an effective and well tolerated cytoreductive option for treatment of [newly diagnosed glioblastoma multiforme (GBM), recurrent GBM, and primary or recurrent brain metastases.] Intracranial LITT is also an effective option for addressing radiation necrosis with an overall reduction in steroid dependence for these patients. Especially in instances where the therapeutic window is narrowed such that craniotomy is not a viable option, LITT can play an important role in treatment for glioma or metastatic brain cancer."
The American Society for Radiation Oncology (ASTRO) clinical practice guideline on radiotherapeutic and surgical management for newly diagnosed brain metastases (2012) does not address the use of LITT (Tsao, 2012).
In September 2021, the American Society for Stereotactic and Functional Neurosurgery (ASSFN) issued a position statement on the use of LITT in drug-resistant epilepsy (Wu, 2021). The statement recommends consideration of MR-guided LITT (MRgLITT) as a treatment option when all of the following criteria are met:
The Congress of Neurological Surgeons (CNS) guidelines for the treatment of adults with metastatic brain tumors state that "there is insufficient evidence to make a recommendation regarding the routine use of laser interstitial thermal therapy (LITT), aside from use as part of approved clinical trials" (Elder, 2019).
The National Comprehensive Cancer Network (NCCN) clinical practice guidelines for central nervous system cancers (v.2.2021) states that MRI-guided laser interstitial thermal therapy "may be considered for patients who are not surgical candidates (craniotomy or resection). Potential indications include relapsed brain metastases and radiation necrosis" (Category 2B) (NCCN, 2021).
In 2020, the National Institute for Health and Care Excellence (NICE) published an interventional procedures guidance on the use of MRI-guided LITT for drug-resistant epilepsy (NICE, 2020). The NICE recommends that LITT should only be used with special arrangements, given serious but well-recognized safety concerns and low quality evidence for efficacy.
In 1997, the Centers for Medicare and Medicaid Services (CMS) issued a national coverage determination on the use of laser procedures, stating that "in the absence of a specific noncoverage instruction, and where a laser has been approved for marketing by the Food and Drug Administration, Medicare Administrative Contractor discretion may be used to determine whether a procedure performed with a laser is reasonable and necessary, and, therefore, covered" (CMS, 1997).
Current ongoing and unpublished trials:
Ongoing Trials
Unpublished Trials
2023 Update
Annual policy review completed with a literature search using the MEDLINE database through October 2023. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below
A multicenter, retrospective study of patients undergoing treatment for biopsy-proven brain metastasis recurrence after stereotactic radiotherapy (SRT) was published in 2022 (Grabowski, 2022). Patients were stratified into three groups: planned LITT plus SRT (n=21), LITT alone (n=25), or repeat SRT alone (n=9). Mean patient age was60 years (range, 37 to 86) and median follow-up duration was 7.3 months (range, 1.0 to 30.5). No patients in the LITT plus SRT group received prior surgery or WBRT, compared to 20% and 28% treated with LITT alone and 11% and 56% treated with SRT alone (p=.05 and.01, respectively). Median time to index lesion progression for LITT plus SRT, LITT alone, and repeat SRT alone was 29.8, 7.5, and 3.7 months, respectively (p=.022). A univariate analysis found a significantly increased risk of tumor progression among patients receiving prior surgery (hazard ratio [HR], 5.33; 95% CI, 1.41 to 16.93; p=.007). The authors noted that future prospective studies are required to validate these findings.
A retrospective review of an institutional database to identify patients with unifocal, lobar, surgically accessible recurrent glioblastoma who were treated with LITT or resection between 2013 and 2020 was performed (Fadel, 2022).
Of 744 patients identified, a LITT cohort of 17 patients was compared with 23 surgical patients. Baseline characteristics were similar between groups except for average lesion size, which was smaller in patients treated with LITT (4.37 cm3 vs. 7.54 cm3; p=.017). Overall survival (14.1 vs. 13.8 months; p=.578) and PFS (3.7 vs. 3.3 months; p=.004) were not significantly different between groups. Significantly shorter hospital stays were observed in patients treated with LITT (2.2 vs. 3.0 days; p=.004).
A subgroup analysis of LAANTERN registry data focusing on new (n=29) and recurrent (n=60) cases of IDH wild-type glioblastoma was published in 2022 (de Groot, 2022). Median OS was 9.73 months (95% CI, 5.16 to 15.91) for newly diagnosed patients and 8.97 months (95% CI, 6.94 to 12.36) for recurrent patients. Median OS in newly diagnosed patients receiving post-LITT chemo/radiation was 16.14 months (95% CI, 6.11 to not reached).
A systematic review and meta-analysis of bevacizumab versus LITT for the treatment of radiation necrosis in patients with brain metastases previously treated with radiotherapy was published in 2021 (Palmisciano, 2021). Eighteen studies were included for analysis, including 143 patients treated with bevacizumab and 148 treated with LITT. Compared to LITT, a higher proportion of patients treated with bevacizumab experienced symptomatic improvement (73.3% vs. 60.8%) and ability to wean off steroids (66.7% vs. 44.1%), but these differences were not significantly different between groups (p=.187; I2=54.8% and p=.614; I2=25.5%, respectively). At 18months, median OS was significantly higher for patients treated with LITT (46.4% vs. 25%; p=.038; I2=73.7%). Rates of adverse events were similar between bevacizumab (14.7%) and LITT (12.2%) cohorts. This analysis is limited by inclusion of primarily retrospective studies, heterogeneous study populations and treatment centers, and limited patient-level data.
A multicenter, retrospective study of SRS-treated patients with brain metastases who developed biopsy-proven radiation necrosis who were treated with LITT (n=57) or medical management (n=15) was performed in 2022 (Sankey, 2022). Median follow-up was 10.0 months (range, 4.2 to 25.1 months). There was no significant difference in median OS (15.2 vs. 11.6 months; p=.60) or freedom from local progression (13.6 vs. 7.06 months; p=.40) in LITT or medical management cohorts, respectively. Patients were able to discontinue steroid therapy earlier in the LITT cohort at a median of 37 versus 245 days (p<.001). The authors note that prospective trials should be designed to validate the utility of LITT for radiation necrosis, including its impact on steroid-induced morbidity.
The purpose of LITT is to use a focused thermal therapy technique to ablate epileptogenic foci when seizures have become drug-resistant or medication-related adverse events are intolerable, and to potentially avoid complications associated with alternative surgical interventions.
The following PICO was used to select literature to inform this review.
The population of interest is patients with drug-resistant or medication-intolerant epilepsy, defined as failure to achieve sustained seizure freedom despite adequate trials of 2 or more appropriately chosen and tolerated antiseizure medications, as specified by the International League Against Epilepsy (ILAE) Commission on Therapeutic Strategies consensus definition for drug resistant epilepsy (Kwan, 2010).
Epilepsy is diagnosed when an individual has unprovoked seizures. Primary seizure disorders include multiple subtypes that are recognizable by the degree and type of impairment of consciousness and motor capacity. Seizure disorders may be secondary to brain tumors or other space-occupying intracranial lesions such as congenital malformations, stroke, genetic syndromes, brain trauma, and cerebral infections. Mesial temporal lobe epilepsy (mTLE), also known as complex partial seizures, is a focal epilepsy syndrome. The epileptogenic foci may present in the hippocampus, amygdala, or parahippocampal gyrus. The most common non-traumatic or non-infectious etiology of TLE is hippocampal sclerosis. The associated neuronal loss is a partial explanation for the difficulties in achieving satisfactory seizure control with antiepileptic medication. Approximately one-third of patients with epilepsy do not achieve adequate seizure control with antiepileptic drugs.
Patients with an identifiable seizure focus that can be targeted to achieve seizure freedom are primary candidates for epilepsy surgery, but patients with multifocal or generalized epilepsy may also be considered.
A systematic review and meta-analysis of LITT treatment outcomes among patients with drug-resistant epilepsy of varying etiologies was published in 2022 (Barot, 2022). Twenty-eight studies representing 559 patients were identified. The overall prevalence of Engel class I outcomes was 56% (95% CI, 52% to 60%). Highest seizure freedom rates were observed among patients with hypothalamic hamartomas (67%; 95% CI, 57% to 76%). Comparable seizure freedom rates were observed between patients with mTLE (56%; 95% CI, 50% to 61%) and extratemporal epilepsy (50%; 95% CI, 40% to 59%). The overall rate of adverse events was 19% (95% CI, 0.14%to 25%), of which visual field defects were most common.
A systematic review and meta-analysis comparing open surgical resection, SRS, LITT, and radiofrequency ablation in drug-resistant mTLE was conducted in 2021 (Marathe, 2021). Forty-one publications were included in the analysis, including 19 studies on open surgery, 11 on LITT, 4 on radiofrequency, and 7 on radiosurgery. The pooled seizure-free rate per person-year was 0.72 (95% CI, 0.66 to 0.79) with trans-sylvian selective amygdalohippocampectomy (sAHE), 0.70 (95% CI, 0.64 to 0.77) with anterior temporal lobe resection (ATL), 0.60 (95% CI, 0.49 to 0.73) with transcortical sAHE, 0.59 (95% CI, 0.53 to 0.65) with LITT, 0.50 (95% CI, 0.34 to 0.73) with SRS, and 0.38 (95% CI, 0.14 to 1.00) with radiofrequency ablation. The authors concluded that while there is no evidence to suggest that LITT is less effective than open surgical resection in the short term, long-term data are lacking and an RCT comparing LITT to open surgical methods is needed. Additionally, reporting of secondary neuropsychological and treatment-related morbidity outcomes is inconsistent and lacks standardization.
A retrospective review of long-term seizure and psychiatric outcomes among patients who underwent LITT for drug-resistant mTLE between 2013 and 2019 at a single academic center was conducted in 2022 (Kanner, 2022). Forty-eight patients (mean age, 43 years) were identified with a mean follow-up duration of 50 ± 20.7 months (range, 18 to 81). Engel class I outcomes were achieved in 29 (60.4%) subjects and 11 (22.9%) reported 1 to 3 seizures per year. The seizure-freedom rate was 77.8%among patients with 24-month follow-up which decreased to 50% among patients with >61-month follow-up data. Seizure freedom was associated with mesial temporal sclerosis, no pre-treatment focal to bilateral tonic-clonic seizures, and no psychopathology in the last follow-up year. Mood and/or anxiety orders were identified in 30 (62.5%) of patients pre-surgery, of which 19 (62%) remitted following LITT.
In 2021, the American Society of Clinical Oncology (ASCO) issued a joint evidence-based guideline on the treatment of brain metastases with the Society for Neuro-Oncology (SNO) and the American Society for Radiation Oncology (ASTRO). The guideline stated that "no recommendation can be made for or against laser interstitial thermal therapy (Type: informal consensus; Evidence quality: low; Strength of recommendation: none)."
2024 Update
Annual policy review completed with a literature search using the MEDLINE database through December 2023. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
A systematic review was published of comparative and descriptive studies (excluding case reports) assessing the evidence for LITT in primary and metastatic brain tumors (Alkazemi, 2023). A total of 45 studies (N=826) were included. Lesions were categorized as high-grade gliomas (n=361), low-grade gliomas (n=116),metastatic brain tumors (n=337), or nonglial tumors (n=15). The majority of studies offered LITT in patients with inaccessible or deep tumors (n=12), after failed radiosurgery (n=9), or were nonspecific (n=12). One-year PFS was 19.6% (95% confidence interval [CI,] 11.3% to 29.0%; I2=0%) in high-grade gliomas, 16.9%(95% CI, 11.6% to 24.0%; I2=0%) in grade 4 astrocytomas, and 51.2% (95% CI, 36.7% to 65.5%; I2=0%) in brain metastases. One-year OS was 43.0% (95% CI,36.0%-50.0%; I2=7.6%) in high-grade glioma, 45.9% (95% CI, 37.9% to 54%; I2=0%) in grade 4 astrocytomas, 93.0% (95% CI, 42.3% to 100%; I2=not applicable) in low-grade gliomas, and 56.3% (95% CI, 47.0% to 65.3%; I2=not applicable) in brain metastases. Major procedure-related adverse events (AEs)was 30% (95% CI, 27% to 40%) with a 16% incidence (95% CI, 12% to 22%) of major or minor neurological deficits. This study is limited by lack of comparator data.
A prospective observational study was conducted of consecutive LITT-treated patients with drug-resistant epilepsy from 2013 to 2021 (Esmaeili, 2023). The primary outcome was sudden unexpected death in epilepsy (SUDEP). There were 4 SUDEP cases among 135 patients over a median duration of 3.5 years(range, 0.1 to 9.0) for an estimated SUDEP incidence of 8 per 1000 person-years. Among a historical control group, the incidence of SUDEP was estimated to be2 per 1000 person-years in patients who underwent resection surgery and 6.1 per 1000 years in patients who did not receive surgical intervention but were candidates. Thus, LITT-treated patients had significantly higher SUDEP incidence compared with surgery (p=.02) but similar rates compared with those without intervention (p=.55).
|
|
|
|
| CPT/HCPCS: | |
|
|
|
| References: |
Ahluwalia M, Barnett GH, Deng D, et al.(2018) Laser ablation after stereotactic radiosurgery: a multicenter prospective study in patients with metastatic brain tumors and radiation necrosis. J Neurosurg. May 04 2018; 130(3): 804-811. PMID 29726782 Alkazemi M, Lo YT, Hussein H, et al.(2023) Laser Interstitial Thermal Therapy for the Treatment of Primary and Metastatic Brain Tumors: A Systematic Review and Meta-Analysis. World Neurosurg. Mar 2023; 171: e654-e671. PMID 36549438 Barnett G, Leuthardt E, Rao G, et al.(2021) American Association of Neurological Surgeons and Congress of Neurological Surgeons (AANS-CNS) Position Statement on MR-guided Laser Interstitial Thermal Therapy (LITT) for Brain Tumors and Radiation Necrosis. September 2021; https://www.aans.org/-/media/Files/AANS/Advocacy/PDFS/AANS-CNS_Position_Statement_Paper_LITT_Tumor-Oncology_090721.ashx. Accessed November 3, 2021. Barnett GH, Voigt JD, Alhuwalia MS.(2016) A Systematic Review and Meta-Analysis of Studies Examining the Use of Brain Laser Interstitial Thermal Therapy versus Craniotomy for the Treatment of High-Grade Tumors in or near Areas of Eloquence: An Examination of the Extent of Resection and Major Complication Rates Associated with Each Type of Surgery. Stereotact Funct Neurosurg. 2016; 94(3): 164-73. PMID 27322392 Barot N, Batra K, Zhang J, et al.(2022) Surgical outcomes between temporal, extratemporal epilepsies and hypothalamic hamartoma: systematic review and meta-analysis of MRI-guided laser interstitial thermal therapy for drug-resistant epilepsy. J Neurol Neurosurg Psychiatry. Feb 2022; 93(2): 133-143. PMID 34321344 Brotis AG, Giannis T, Paschalis T, et al.(2021) A meta-analysis on potential modifiers of LITT efficacy for mesial temporal lobe epilepsy: Seizure-freedom seems to fade with time. Clin Neurol Neurosurg. Apr 20 2021; 205: 106644. PMID 33962146 Carpentier A, Chauvet D, Reina V, et al.(2012) MR-guided laser-induced thermal therapy (LITT) for recurrent glioblastomas. Lasers Surg Med. 2012 Jul;44(5):361-8. Carpentier A, McNichols RJ, Stafford RJ, et al.(2008) Real-time magnetic resonance-guided laser thermal therapy for focal metastatic brain tumors. Neurosurgery. 2008 Jul;63(1 Suppl 1):ONS21-8. Carpentier A, McNichols RJ, Stafford RJ, et al.(2011) Laser thermal therapy: real-time MRI-guided and computer-controlled procedures for metastatic brain tumors. Lasers Surg Med. 2011 Dec;43(10):943-50. Centers for Medicare and Medicaid Services (CMS).(1997) National Coverage Determination: Laser Procedures (140.5). 1997; https://www.cms.gov/medicare-coverage-database/view/ncd.aspx?NCDId=69&ncdver=1&DocID=140.5. Accessed November 3, 2021 Chen C, Guo Y, Chen Y, et al.(2021) The efficacy of laser interstitial thermal therapy for brain metastases with in-field recurrence following SRS: systemic review and meta-analysis. Int J Hyperthermia. 2021; 38(1): 273-281. PMID 33612043 de Franca SA, Tavares WM, Salinet ASM, et al.(2020) Laser interstitial thermal therapy as an adjunct therapy in brain tumors: A meta-analysis and comparison with stereotactic radiotherapy. Surg Neurol Int. 2020; 11: 360. PMID 33194293 de Groot JF, Kim AH, Prabhu S, et al.(2022) Efficacy of laser interstitial thermal therapy (LITT) for newly diagnosed and recurrent IDH wild-type glioblastoma. Neurooncol Adv. 2022; 4(1): vdac040. PMID 35611270 Elder JB, Chiocca EA.(2013) Glioblastoma multiforme and laser interstitial thermal therapy. J Neurosurg 118:1199-1201, 2013. Elder JB, Nahed BV, Linskey ME, et al.(2019) Congress of Neurological Surgeons Systematic Review and Evidence-Based Guidelines on the Role of Emerging and Investigational Therapies for the Treatment of Adults With Metastatic Brain Tumors. Neurosurgery. Mar 01 2019; 84(3): E201-E203. PMID 30629215 Esmaeili B, Hakimian S, Ko AL, et al.(2023) Epilepsy-Related Mortality After Laser Interstitial Thermal Therapy in Patients With Drug-Resistant Epilepsy. Neurology. Sep 26 2023; 101(13): e1359-e1363. PMID 37202163 Fadel HA, Haider S, Pawloski JA, et al.(2022) Laser Interstitial Thermal Therapy for First-Line Treatment of Surgically Accessible Recurrent Glioblastoma: Outcomes Compared With a Surgical Cohort. Neurosurgery. Nov 01 2022; 91(5): 701-709. PMID 35986677 Grabowski MM, Srinivasan ES, Vaios EJ, et al.(2022) Combination laser interstitial thermal therapy plus stereotactic radiotherapy increases time to progression for biopsy-proven recurrent brain metastases. Neurooncol Adv. 2022; 4(1): vdac086. PMID 35795470 Grewal SS, Alvi MA, Lu VM, et al.(2019) Magnetic Resonance-Guided Laser Interstitial Thermal Therapy Versus Stereotactic Radiosurgery for Medically Intractable Temporal Lobe Epilepsy: A Systematic Review and Meta-Analysis of Seizure Outcomes and Complications. World Neurosurg. Feb 2019; 122: e32-e47. PMID 30244184 Hale AT, Sen S, Haider AS, et al.(2019) Open Resection versus Laser Interstitial Thermal Therapy for the Treatment of Pediatric Insular Epilepsy. Neurosurgery. Oct 01 2019; 85(4): E730-E736. PMID 30888028 Hawasli AH, Ray WZ, Murphy RK.(2012) Magnetic resonance imaging-guided focused laser interstitial thermal therapy for subinsular metastatic adenocarcinoma: technical case report. Neurosurgery. 2012 Jun;70(2 Suppl Operative):332-7. Holste KG, Orringer DA.(2020) Laser interstitial thermal therapy. Neurooncol Adv. Jan-Dec 2020; 2(1): vdz035. PMID 32793888 Hong CS, Deng D, Vera A, et al.(2019) Laser-interstitial thermal therapy compared to craniotomy for treatment of radiation necrosis or recurrent tumor in brain metastases failing radiosurgery. J Neurooncol. Apr 2019; 142(2): 309-317. PMID 30656529 Hoppe C, Helmstaedter C.(2020) Laser interstitial thermotherapy (LiTT) in pediatric epilepsy surgery. Seizure. Apr 2020; 77: 69-75. PMID 30591281 Kanner AM, Irving LT, Cajigas I, et al.(2022) Long-term seizure and psychiatric outcomes following laser ablation of mesial temporal structures. Epilepsia. Apr 2022; 63(4): 812-823. PMID 35137956 Kim AH, Tatter S, Rao G, et al.(2020) Laser Ablation of Abnormal Neurological Tissue Using Robotic NeuroBlate System (LAANTERN): 12-Month Outcomes and Quality of Life After Brain Tumor Ablation. Neurosurgery. Sep 01 2020; 87(3): E338-E346. PMID 32315434 Kohlhase K, Zollner JP, Tandon N, et al.(2021) Comparison of minimally invasive and traditional surgical approaches for refractory mesial temporal lobe epilepsy: A systematic review and meta-analysis of outcomes. Epilepsia. Apr 2021; 62(4): 831-845. PMID 33656182 Kwan P, Arzimanoglou A, Berg AT, et al.(2010) Definition of drug resistant epilepsy: consensus proposal by the ad hoc Task Force of the ILAE Commission on Therapeutic Strategies. . Epilepsia. Jun 2010; 51(6): 1069-77. PMID 19889013 Lagman C, Chung LK, Pelargos PE, et al.(2017) Laser neurosurgery: A systematic analysis of magnetic resonance-guided laser interstitial thermal therapies. J Clin Neurosci. Feb 2017; 36: 20-26. PMID 27838155 Landazuri P, Shih J, Leuthardt E, et al.(2020) A prospective multicenter study of laser ablation for drug resistant epilepsy - One year outcomes. Epilepsy Res. Nov 2020; 167: 106473. PMID 33045664 Marathe K, Alim-Marvasti A, Dahele K, et al.(2021) Resective, Ablative and Radiosurgical Interventions for Drug Resistant Mesial Temporal Lobe Epilepsy: A Systematic Review and Meta-Analysis of Outcomes. Front Neurol. 2021; 12: 777845. PMID 34956057 Medvid R, Ruiz A, Komotar RJ, et al.(2015) Current Applications of MRI-Guided Laser Interstitial Thermal Therapy in the Treatment of Brain Neoplasms and Epilepsy: A Radiologic and Neurosurgical Overview. AJNR Am J Neuroradiol. Nov 2015; 36(11): 1998-2006. PMID 26113069 Mohammadi AM, Hawasli AH, Rodriguez A, et al.(2014) The role of laser interstitial thermal therapy in enhancing progression-free survival of difficult-to-access high-grade gliomas: a multicenter study. Cancer Med. 2014 Aug;3(4):971-9. Mohammadi AM, Sharma M, Beaumont TL, et al.(2019) Upfront Magnetic Resonance Imaging-Guided Stereotactic Laser-Ablation in Newly Diagnosed Glioblastoma: A Multicenter Review of Survival Outcomes Compared to a Matched Cohort of Biopsy-Only Patients. Neurosurgery. Dec 01 2019; 85(6): 762-772. PMID 30476325 National Comprehensive Cancer Network (NCCN).(2021) NCCN Clinical Practice Guidelines in Oncology: Central Nervous System Cancers. Version 2.2021; https://www.nccn.org/professionals/physician_gls/pdf/cns.pdf. Accessed November 3, 2021. National Institute for Health and Care Excellence (NICE).(2020) Interventional procedures guidance: MRI-guided laser interstitial thermal therapy for drug-resistant epilepsy [IPG671]. March 4, 2020; https://www.nice.org.uk/guidance/ipg671. Accessed November 3, 2021. NCT00747253.(2012) Monteris AutoLITT™ FIM Safety Trial for Recurrent/Progressive Brain Tumors. www.clinicaltrials.com. Last accessed 11/2/2012. NCT01515085.(2012) MRI-Guided Laser-Induced Thermal Therapy for Cytoreduction of Inoperable Grade III/IV GLiomas Prior to Chemotherapy and Radiation. www.clinicaltrials.com. Last accessed 11/2/2012. NCT01651078.(2012) Laser Ablation After Stereotactic Radiosurgery. A Post-Marketing Surveillance (Phase IV) Multicenter Observational Study. www.clinicaltrials.com. Last accessed 11/2/2012. Palmisciano P, Haider AS, Nwagwu CD, et al.(2021) Bevacizumab vs laser interstitial thermal therapy in cerebral radiation necrosis from brain metastases: a systematic review and meta-analysis. J Neurooncol. Aug 2021; 154(1): 13-23. PMID 34218396 Patel P, Patel NV, Danish SF.(2016) Intracranial MR-guided laser-induced thermal therapy: single-center experience with the Visualase thermal therapy system. J Neurosurg. Oct 2016; 125(4): 853-860. PMID 26722845 Petito GT, Wharen RE, Feyissa AM, et al.(2018) The impact of stereotactic laser ablation at a typical epilepsy center. Epilepsy Behav. Jan 2018; 78: 37-44. PMID 29172137 Rennert RC, Khan U, Bartek J, et al.(2020) Laser Ablation of Abnormal Neurological Tissue Using Robotic Neuroblate System (LAANTERN): Procedural Safety and Hospitalization. Neurosurgery. Apr 01 2020; 86(4): 538-547. PMID 31076762 Sankey EW, Grabowski MM, Srinivasan ES, et al.(2022) Time to Steroid Independence After Laser Interstitial Thermal Therapy vs Medical Management for Treatment of Biopsy-Proven Radiation Necrosis Secondary to Stereotactic Radiosurgery for Brain Metastasis. Neurosurgery. Jun 01 2022; 90(6): 684-690. PMID 35311745 Sloan AE, Ahluwalla MS, Valerio-Pascua J, et al.(2013) Results of the neuroblate system first-in-humans phase I clinical trial for recurrent glioblastoma. J Neurosurg 118:1202-1219, 2013. Stafford RJ, Fuentes D, Elliott AA, et al.(2010) Laser-induced thermal therapy for tumor ablation. Crit Rev Biomed Eng. 2010;38(1):79-100. Sujijantarat N, Hong CS, Owusu KA, et al.(2020) Laser interstitial thermal therapy (LITT) vs. bevacizumab for radiation necrosis in previously irradiated brain metastases. J Neurooncol. Jul 2020; 148(3): 641-649. PMID 32602021 Tsao MN, Rades D, Wirth A, et al.(2012) Radiotherapeutic and surgical management for newly diagnosed brain metastasis(es): An American Society for Radiation Oncology evidence-based guideline. Pract Radiat Oncol. Jul-Sep 2012; 2(3): 210-225. PMID 25925626 US Food and Drug Administration (FDA).(2018) Risk of Tissue Overheating Due to Inaccurate Magnetic Resonance Thermometry: Letter to Health Care Providers. 2018; https://www.fda.gov/medical-devices/letters-health-care-providers/risk-tissue-overheating-due-inaccurate-magnetic-resonance-thermometry-letter-health-care-providers. Accessed November 3, 2021. US Food and Drug Administration (FDA).(2018) Update Regarding Risk of Tissue Overheating Due to Inaccurate Magnetic Resonance Thermometry: Letter to Health Care Providers. 2018; https://www.fda.gov/medical-devices/letters-health-care-providers/update-regarding-risk-tissue-overheating-due-inaccurate-magnetic-resonance-thermometry. Accessed November 2, 2021. Vogelbaum MA, Brown PD, Messersmith H, et al.(2022) Treatment for Brain Metastases: ASCO-SNO-ASTRO Guideline. J Clin Oncol. Feb 10 2022; 40(5): 492-516. PMID 34932393 Wu C, Jermakowicz WJ, Chakravorti S, et al.(2019) Effects of surgical targeting in laser interstitial thermal therapy for mesial temporal lobe epilepsy: A multicenter study of 234 patients. Epilepsia. Jun 2019; 60(6): 1171-1183. PMID 31112302 Wu C, Schwalb JM, Rosenow J, et al.(2021) American Society for Stereotactic and Functional Neurosurgery Position Statement on Laser Interstitial Thermal Therapy for the Treatment of Drug-Resistant Epilepsy. September 2021; https://www.aans.org/-/media/Files/AANS/Advocacy/PDFS/ASSFN_Position_Statement_on_LITT_for_the_Treatment_of_Drug_Resistant_Epilepsy_091321.ashx. Accessed November 3, 2021. Xue F, Chen T, Sun H.(2018) Postoperative Outcomes of Magnetic Resonance Imaging (MRI)-Guided Laser Interstitial Thermal Therapy (LITT) in the Treatment of Drug-Resistant Epilepsy: A Meta-Analysis. Med Sci Monit. Dec 21 2018; 24: 9292-9299. PMID 30573725 |
|
|
|
|
Group specific policy will supersede this policy when applicable. This policy does not apply to the Wal-Mart Associates Group Health Plan participants or to the Tyson Group Health Plan participants.
CPT Codes Copyright © 2024 American Medical Association. |
|