ZAP-X Gyroscopic Radiosurgery System: A Preliminary Analysis of Clinical Applications within a Retrospective Case Series

Author(s):  
Benjamin K. Hendricks ◽  
Joseph D. DiDomenico ◽  
Igor J. Barani ◽  
F. David Barranco

<b><i>Introduction:</i></b> The ZAP-X Gyroscopic Radiosurgery system (ZAP Surgical Systems, Inc., San Carlos, CA, USA) is a novel high-dose targeted stereotactic radiosurgery platform for outpatient use that includes self-shielding, X-ray image guidance, and the capacity to aim the radiation beam gyroscopically at an intracranial lesion using 5 independent degrees of freedom. The ZAP-X Gyroscopic Radiosurgery system accomplishes these actions while meeting widely accepted standards for dose gradient and accuracy. This retrospective study examined data of patients treated with gyroscopic radiosurgery (GRS) to document clinical outcomes. <b><i>Methods:</i></b> Medical records of all outpatients treated with GRS over a 20-month period from January 2019 to August 2020 were searched to extract relevant details, including follow-up data until August 2021 (32-month study interval). Patients with &#x3c;6 months of radiographical follow-up data were excluded unless death occurred. Data collection included pretreatment clinical history, pathological diagnosis, radiographical features, treatment parameters, and long-term clinical and radiographical follow-up. <b><i>Results:</i></b> Sixty-eight patients received outpatient treatment with GRS during the 20-month treatment interval, with 59 patients remaining after exclusion for the minimum follow-up threshold, with a mean (standard deviation [SD]) fractionation of 1.85 (1.63). Eighty-two lesions were treated across a very heterogeneous patient population, including meningiomas (42.4%), metastases (39.0%), gliomas (6.8%), schwannomas (1.7%), and pituitary tumor (1.7%). Mean (SD) radiographical follow-up data (14.7 [6.60] months) were available for 56 patients. During that interval, 13 treated lesions in 13 patients (15.9%) demonstrated progression, 9 of which were stable during the initial posttreatment imaging surveillance period. Mean lesion volume was stable from pretreatment (2.54 cm<sup>3</sup> [4.37 cm<sup>3</sup>]) to most recent follow-up (2.80 cm<sup>3</sup> [8.20 cm<sup>3</sup>]) (<i>t</i> [79] = −0.310; <i>p</i> = 0.76). Minor adverse clinical events were noted in 3 (5.1%) of the 59 patients during the posttreatment phase that may have been related to the treatment. Ten (16.9%) patients died within the 32-month study interval. <b><i>Discussion/Conclusion:</i></b> This preliminary assessment of the first series of patients treated with the Zap-X Gyroscopic Radiosurgery system documents its overall feasibility in clinical applications. Although the duration of follow-up was brief, GRS appeared to be both safe and effective. Additional analysis, with an ongoing prospective registry, is underway.

2019 ◽  
Vol 44 (2) ◽  
pp. 60
Author(s):  
Theresia Yinski ◽  
Syntia Nusanti

Introduction : Methanol-induced toxic optic neuropathy (TON) is defined as a visual impairment due to optic nerve damage by methanol poisoning. Not only is this disease entity underdiagnosed at times, this sudden blindness is also often diagnosed at a stage where recovery of vision is no longer possible. Materials and Methods : A literature search was conducted using PubMed, ClinicalKey, Google Scholar and ScienceDirect by combining the keywords ‘methanol’ or ‘methyl alcohol’, ‘intoxication’ or ‘poisoning’, ‘toxic optic neuropathy’, and ‘visual acuity’ with ‘high-dose steroid’. Results : The total amount of subjects in each article varied from 2 to 37, with mean age distribution of 26.34 to 55 years old, where most patients were male. The follow up duration varied from 1 week to 1 year. Four articles do not mention high-dose steroids treatment as therapy while the other four mention use of 1000 mg of intravenous methylprednisolone per day with divided doses of either 2x500 mg or 4x250 mg. Improvement percentages show 100% improvement in all studies that used high-dose steroids, while in the non-high-dose steroids studies the improvement percentages range from 33.33% to 90%. Summary : High-dose steroids are showing efficacy in improving visual acuity and reducing the inflammation in methanol-induced TON. The period of how fast the therapy takes effect is inconclusive, as the mean follow-up time differs widely per study. However, because most of the reviewed studies here are retrospective case series, a larger, more comprehensive study is required to acknowledge more of the efficacy profile.


2020 ◽  
pp. 000348942097023
Author(s):  
Sungjin A. Song ◽  
Kanittha Choksawad ◽  
Ramon A. Franco

Objective: To determine the effectiveness of nortriptyline and tolerability of side effects in the treatment of neurogenic cough. Secondary goal is to evaluate the association between laryngeal asymmetry and clinical response to nortriptyline. Study Design: Retrospective case series. Materials and Methods: Consecutive patients diagnosed with neurogenic cough at a quaternary care specialty hospital from 2001 to 2020 were identified. Subjects <18 years old, not treated with nortriptyline, did not have a nasolaryngoscopic examination and were lost to follow-up were excluded. Charts were reviewed for demographic information, clinical history, nasolaryngoscopic findings, medication dosage, side effects, and follow-up time. Results: Forty-two patients met inclusion and exclusion criteria, 7 males and 35 females with an average age of 56.5 (±13.1) years. There were 26/36 (72.2%) responders and 10/36 (27.8%) non-responders; 6 patients stopped nortriptyline due to side effects and were not included in the response comparison. Laryngeal asymmetry was present in 36/42 (85.7%) patients. No factors related to laryngeal asymmetry were significantly different between responders and non-responders. Medication tolerance was observed in 3/42 (7.1%) patients. Side effects were reported in 16/42 (38.1%) patients. The most common side effects were sedation 9/42 (21.4%) and xerostomia 3/42 (7.1%). Conclusion: Nortriptyline is effective for treating neurogenic cough with 72% of patients reporting improvement in cough. Evidence of laryngeal asymmetry was not associated with better treatment response. Although 38% experienced side effects, the majority of patients continued nortriptyline despite side effects. Level of Evidence: 4


2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e22525-e22525 ◽  
Author(s):  
Vittoria Colia ◽  
Angelo Paolo Dei Tos ◽  
Elena Fumagalli ◽  
Rossella Bertulli ◽  
Domenica Lorusso ◽  
...  

e22525 Background: BML is a rare entity marked by the presence of lung lesions in women with a history of surgery for a benign leiomyoma of the uterus. Optimal treatment strategy for BML is poorly defined. We report on the activity of systemic therapy in a retrospective series of pts with BML. Methods: Cases diagnosed with BML from June 1993 to January 2017 at Istituto Nazionale Tumori, Milan, were reviewed. Results: Eight pts were identified, with a median age of 43 yrs. Estrogen and progesteron receptors were positive in all cases. All pts underwent surgery (3 hysterectomy, 2 myomectomy, 2 hysteroannessiectomy and 1 left ovariectomy) for suspected uterine leiomyoma (1 leg; 1 thigh); 2 pts had concomitant lung disease. 8 pts developed lung metastases and 2 had also limb metastases. 2 pts underwent lung metastasectomy, followed by watchful waiting with CT every 6 mos and were disease-free at their last follow up after 132 mos and 84 mos from diagnosis. 6 pts received systemic therapy for progressing advanced disease (1-6 lines). Among 6 pts treated, 2 were in fertility age and underwent ovary-sparing hysterectomy, receiving GnRH agonist with 1 PR lasting 96 mos and 1 SD lasting 38 mos; 2 pts received an aromatase inhibitor with 1 PR lasting 24 mos and 1 SD lasting 12 mos; 2 pts received oral estrogens with 1 PR lasting 39 mos and 1 SD lasting 2 mos; 1 pt received oral progestins with a PR lasting 12 mos; 3 patients received antracyclin +/- ifosfamide obtaining 2 PR after 3 cycles (cys) and 1 SD after 3 cys lasting 6 mos; 1 pt received high-dose ifosfamide with a PR after 5 cys; 1 pt received ifosfamide+dacarbazine obtaining a CR after 6 cys; 2 pts received gemcitabine with 1 PR after 3 cys and 1 SD after 2 cys lasting 6 mos; 1 pt received oral etoposide with a PR lasting 21 mos; 1 pt received sorafenib with a SD lasting 6 mos; 1 pt received everolimus with a PR lasting 57 mos. In this case, everolimus was discontinued due to lung toxicity. No pts progressed during treatment. At a median follow-up of 55 mos, 6 pts are alive, while 2 are dead of disease. Conclusions: In a series of 8 pts, we confirm the activity of hormonal treatment in BML. mTOR inihibitors or chemotherapy also show to be active.


2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 388.2-389
Author(s):  
A. Rubbert-Roth ◽  
P. K. Bode ◽  
T. Langenegger ◽  
C. Pfofe ◽  
T. Neumann ◽  
...  

Background:Giant cell arteritis (GCA) may affect the aorta and the large aortic branches and lead to dissections and aortic aneurysms. Tocilizumab (TCZ) treatment has the capacity to control aortic inflammation as has been demonstrated by CRP normalization and imaging data. However, limited data are available on the histopathological findings obtained from patients who underwent surgery because of aortic complications during TCZ treatment.Objectives:We report on 5 patients with aortitis who were treated with TCZ and developed aortic complications.Methods:We describe a retrospective case series of patients with GCA treated with TCZ, who presented in our clinic between 2011 and 2019. Three patients underwent surgery. Histopathologic examination was performed in specimen from all of them.Results:Five female patients were diagnosed with GCA (4/5) or Takaysu arteritis (1/5) involving the aorta, all them diagnosed by MR angiography and/or FDG PET CT scan. Three patients (one with aortic aneurysm, one with dissection) underwent surgery after having been treated with TCZ for seven weeks, nine months and four years, respectively. Imaging before surgery showed remission on MRI and/or PET-CT in all cases. At the time of surgery, all patients showed normalized CRP and ESR values. Histopathological evaluation of the aortic wall revealed infiltrates, consisting predominantly of CD3+CD4+ T cells. Enlargement of pre-existing aneuryms was observed in the other two patients 10 weeks and 4 months after discontinuation of TCZ, respectively. Both patients were not eligible for surgical intervention and died during follow-up.Conclusion:Our case series suggests that during treatment with TCZ, regular imaging is necessary in this patient population to detect development of structural changes such as aneurysms or dissections. Despite treatment, residual inflammation might persist which could contribute to eventual aortic complications.Disclosure of Interests:Andrea Rubbert-Roth Consultant of: Abbvie, BMS, Chugai, Pfizer, Roche, Janssen, Lilly, Sanofi, Amgen, Novartis, Peter Karl Bode: None declared, Thomas Langenegger: None declared, Claudia Pfofe: None declared, Thomas Neumann: None declared, Olaf Chan-Hi Kim: None declared, Johannes von Kempis Consultant of: Roche


2020 ◽  
Vol 22 (Supplement_3) ◽  
pp. iii324-iii324
Author(s):  
Derek Hanson ◽  
Nicolas Andre ◽  
Susan Chi ◽  
Mariella Filbin ◽  
Michael Fisher ◽  
...  

Abstract Embryonal tumors with multilayer rosettes (ETMR) are rare and highly-aggressive central nervous system (CNS) neoplasms which occur primarily in young children and carry a dismal prognosis. To date, no large clinical investigations have been conducted to determine the optimal therapy for ETMR. Data from retrospective case series suggest that our most aggressive standard therapies are not sufficient for cure in the majority of cases. New treatment approaches incorporating pre-clinical data and the known biology of ETMR are therefore urgently needed. A German drug screen using the patient-derived ETMR BT183 cell line and its xenograft revealed anti-tumor activity of topotecan, doxorubicin, and actinomycin D; three agents used infrequently for treating infant CNS tumors. Additional results from a small series of ETMR patients suggest that optimization of induction chemotherapy using these active agents may improve response and survival outcomes. In 2019, an international panel of pediatric neuro-oncology experts convened to advance therapy for ETMR. A consensus protocol was developed incorporating maximal safe surgical resection, induction chemotherapy with active pre-clinical agents, intrathecal chemotherapy, radiotherapy, and high-dose chemotherapy. This international consensus protocol represents the first prospective clinical investigation specific to ETMR and will be available through a treatment registry globally and as a clinical trial at select centers. The study aims to improve survival by providing aggressive, optimized therapy for ETMR and will serve as a platform to explore new biologically-promising agents. The investigation will also provide valuable prospective outcome data and correlative biological studies to serve as baseline comparators for future clinical trials.


Author(s):  
Gabriele Colo’ ◽  
Mattia Alessio Mazzola ◽  
Giulio Pilone ◽  
Giacomo Dagnino ◽  
Lamberto Felli

Abstract The aim of this study is to evaluate the results of patients underwent lateral open wedge calcaneus osteotomy with bony allograft augmentation combined with tibialis posterior and tibialis anterior tenodesis. Twenty-two patients underwent adult-acquired flatfoot deformity were retrospectively evaluated with a minimum 2-year follow-up. Radiographic preoperative and final comparison of tibio-calcaneal angle, talo–first metatarsal and calcaneal pitch angles have been performed. The Visual Analog Scale, American Orthopedic Foot and Ankle Score, the Foot and Ankle Disability Index and the Foot and Ankle Ability Measure were used for subjective and functional assessment. The instrumental range of motion has been also assessed at latest follow-up evaluation and compared with preoperative value. There was a significant improvement of final mean values of clinical scores (p < 0.001). Nineteen out of 22 (86.4%) patients resulted very satisfied or satisfied for the clinical result. There was a significant improvement of the radiographic parameters (p < 0.001). There were no differences between preoperative and final values of range of motion. One failure occurred 7 years after surgery. Adult-acquired flatfoot deformity correction demonstrated good mid-term results and low recurrence and complications rate. Level of evidence Level 4, retrospective case series.


2021 ◽  
pp. 1-9
Author(s):  
Biljana Kuzmanović Elabjer ◽  
Mladen Bušić ◽  
Andrej Pleše ◽  
Mirjana Bjeloš ◽  
Daliborka Miletić ◽  
...  

<b><i>Introduction:</i></b> Ultrasound biomicroscopy (UBM) is the only widely used method for the evaluation of anterior uveal melanoma (AUM). <b><i>Objective:</i></b> Documentation of regression of AUM treated with ruthenium-106 (Ru-106) plaque types CCB and CCC using UBM. <b><i>Methods:</i></b> This single institution-based retrospective case series involved 10 Caucasian patients with AUM followed after brachytherapy with UBM from January 2014 until February 2019. The largest prominence of the tumor perpendicular to the sclera or the cornea (including scleral/corneal thickness) (<i>D</i>) and the largest basal dimension (<i>B</i>) were measured in millimeters with UBM for all patients prior to the brachytherapy and at 4-month interval follow-up. Tumor regression was calculated as a percentage of decrease in the initial <i>D</i> and <i>B</i> values. <b><i>Results:</i></b> The study involved 10 patients with a mean age of 64.4 years (yr) (range 46–80 yr). <i>D</i> ranged from 1.82 to 5.5 mm (median 2.99 mm) and <i>B</i> from 2.32 to 12.38 mm (median 4.18 mm). The apical radiation dose in all patients was 100 Gy. The median follow-up was 42.02 months. Regression for <i>D</i> was 21.11 ± 13.66%, 31.09 ± 14.66%, and 34.92 ± 19.86% at 1st, 2nd, and 3rd year of the follow-up, respectively, while for <i>B</i> it was 21.58 ± 16.05%, 28.98 ± 17.71%, and 32.06 ± 18.96%, respectively. Tumor recurrence was documented in 2/10 patients. <b><i>Conclusion:</i></b> The major regression of AUM, treated with Ru-106 plaque types CCB and CCC, was documented in the first 2 years after brachytherapy in our study group. In the following years, only minimal regression was documented that warns of the need for close monitoring and active search for local recurrences.


2021 ◽  
pp. 112067212110071
Author(s):  
Vijitha S Vempuluru ◽  
Monalisha Pattnaik ◽  
Neha Ghose ◽  
Swathi Kaliki

Purpose: To describe the risk factors, clinical presentation, management, and outcomes of patients with bilateral ocular surface squamous neoplasia (OSSN). Methods: Retrospective case series. Results: Of the 25 patients with bilateral OSSN, the mean age at diagnosis of OSSN was 31 years (median, 24 years; range, 2–60 years). Risk factors for bilateral OSSN included xeroderma pigmentosum ( n = 15, 60%), human immunodeficiency virus infection ( n = 3, 12%), conjunctival xerosis ( n = 1, 4%), and topical steroid use ( n = 1, 4%). There were no identifiable ocular or systemic risk factors in 7 (28%) patients. Presentation was synchronous in 14 (56%) and metachronous in 11 (44%) patients. Tumor morphology was bilaterally similar in 12 (48%) patients. Histopathological examination ( n = 36) revealed conjunctival intraepithelial neoplasia (CIN) grade 1 in 4 (8%); grade 2 in 7 (14%); carcinoma in situ in 5 (10%), and invasive carcinoma in 20 (40%). Primary management of OSSN ( n = 49) included excisional biopsy ( n = 31, 62%), topical immunotherapy (IFN α2B) ( n = 11; 22%), topical Mitomycin C (MMC) ( n = 3, 6%), enucleation ( n = 1, 2%), orbital exenteration ( n = 2, 4%), and plaque brachytherapy (PBT) ( n = 1, 2%). One patient was lost to follow-up after detection of tumor in the second eye. Recurrent tumors were noted in 16 (32%) eyes and binocular globe salvage was achieved in 16 (64%) patients at a mean follow up of 41 months (median 30 months; range, 1–164 months). Conclusion: OSSN occurrence can be synchronous or metachronous. Meticulous examination of the fellow eye is important for an early diagnosis of OSSN.


2021 ◽  
pp. 000348942098740
Author(s):  
Ian Newberry ◽  
Julie Highland ◽  
Alvin DeTorres ◽  
Richard Gurgel

Objective: Comprising 4% of tinnitus, pulsatile tinnitus (PT) can be particularly difficult for affected patients as well as surgeons looking to address their symptoms. Often the cause is not identified but can be secondary to turbulent flow in or near the sigmoid sinus, particularly if there is an identifiable sigmoid sinus dehiscence (SSDe) and/or diverticulum (SSDi). These sigmoid sinus wall anomalies (SSWA) may be treated with transmastoid sigmoid sinus resurfacing; however, this intervention remains relatively novel and its technique, materials used, resolution success, and complications need to be continuously reviewed. Methods: A retrospective case series of patients with PT due to SSWA at a tertiary referral center was reviewed. A total of 6 patients (7 ears) treated by transmastoid resurfacing using hydroxyapatite (HA) were retrospectively assessed. Pre-operative demographics and symptoms, pre- and post-operative hearing results, and post-operative outcomes were reviewed. Results: All patients were female with an average BMI of 32.9 (±5.4) and a mean age of 45.5 years (±15.3). Mean follow-up was 648 days. Objective tinnitus was noted in all ears with SSDi (100%); however, no objective tinnitus was noted with purely SSDe. In 100% of ears, PT was diminished with ipsilateral jugular compression and was amplified with contralateral head turn. Pre-operative symptoms of PT resolved in all patients, but delayed recurrence (>1 year) occurred in 1 ear (14%). No patient had pre- or post-operative hearing loss. No major complications were encountered. Conclusions: Transmastoid resurfacing for SSWA with HA bone cement is a safe, reliable intervention in properly identified PT patients.


2021 ◽  
pp. 107110072110060
Author(s):  
Michael F. Githens ◽  
Malcolm R. DeBaun ◽  
Kimberly A Jacobsen ◽  
Hunter Ross ◽  
Reza Firoozabadi ◽  
...  

Background: Supination-adduction (SAD) type II ankle fractures can have medial tibial plafond and talar body impaction. Factors associated with the development of posttraumatic arthritis can be intrinsic to the injury pattern or mitigated by the surgeon. We hypothesize that plafond malreducton and talar body impaction is associated with early posttraumatic arthrosis. Methods: A retrospective cohort of skeletally mature patients with SAD ankle fractures at 2 level 1 academic trauma centers who underwent operative fixation were identified. Patients with a minimum of 1-year follow-up were included. The presence of articular impaction identified on CT scan was recorded and the quality of reduction on final intraoperative radiographs was assessed. The primary outcome was radiographic ankle arthrosis (Kellgren-Lawrence 3 or 4), and postoperative complications were documented. Results: A total of 175 SAD ankle fractures were identified during a 10-year period; 79 patients with 1-year follow-up met inclusion criteria. The majority of injuries resulted from a high-energy mechanism. Articular impaction was present in 73% of injuries, and 23% of all patients had radiographic arthrosis (Kellgren-Lawrence 3 or 4) at final follow-up. Articular malreduction, defined by either a gap or step >2 mm, was significantly associated with development of arthrosis. Early treatment failure, infection, and nonunion was rare in this series. Conclusion: Malreduction of articular impaction in SAD ankle fractures is associated with early posttraumatic arthrosis. Recognition and anatomic restoration with stable fixation of articular impaction appears to mitigate risk of posttraumatic arthrosis. Investigations correlating postoperative and long-term radiographic findings to patient-reported outcomes after operative treatment of SAD ankle fractures are warranted. Level of Evidence: Level IV, retrospective case series.


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