Stereotactic Radiotherapy for the Treatment of Recurrent Refractory Vt in Chagas Disease Patients

Background: Stereotactic radiotherapy (SBRT) is a new therapeutic option for patients with scar related ventricular tachycardia (VT). Objective(s): To describe our experience with the use of SBRT for the treatment of recurrent VT in patients with Chagas Cardiomyopathy (CCM) in whom catheter ablation is not an option. Method(s): We selected patients with Chagas Disease that underwent SBRT for recurrent VT treatment. The target sites of SBRT were planned based on CMR and CT reconstruction on ADAS software, bipolar voltage maps from previous CA procedures and VT morphology induced on a electrophysiologic study performed SBRT planning. Target sites were decided together by electrophysiology and radiation oncology group. Result(s): We performed SBRT in six CCM patients July 2021 to July 2022. Most patients were male (66.7%), mean age 62.3+/-5.7 years-old and EF 28.5% (Q1: 20 Q3:42.7). One patient (16.7%) had two prior catheter ablation, four (66.7%) had one and one patient had no prior ablation, but had severe pulmonary fibrosis after COVID and was O2 dependent. The mean PTV (planning target volume) was 85+/-14 mL and the ITV (internal target volume) was 29+/-4 ml, with safe constraints regarding the esophagus and stomach. In a mean FU of 244+/-173days, 3 (50%) patients presented VT recurrence after blanking period. Two patients died 86 and 50 days after SBRT. The median number of VT episodes reduced from 13 (6.25;44.75) to 7.5 (3;7.5) (P = 0.093). All alive patients stop presenting VT in a median period of 174 (Q1: 44.75: Q3: 199) days, being at the end of the follow-up in a median of 196 (Q1: 137;Q3: 246) days without new VT episodes. Conclusion(s): SBRT presents a high rate of early recurrence in Chagas disease patients that improves during timeCopyright © 2023

Possible consequences of Covid-19 on the nervous system

OBJECTIVES: The aim of the survey was to find out what the possible consequences are of the COVID-19 disease on the nervous system and to propose a method of using artificial intelligence. MATERIAL AND METHODS: Recent research has shown that the risks to patients due to severe acute coronavirus 2 respiratory syndrome (SARS-COV-2) differ most significantly depending on age and the presence of underlying comorbidities such as: cardiovascular disease, hypertension, diabetes and others. The consequences of COVID-19 on the nervous system are especially important. We performed a detailed selection of articles describing the effects of COVID-19 on the nervous system. RESULT(S): We made a clear summary of the main consequences of COVID-19 on the nervous system and suggested a way to use artificial intelligence. CONCLUSION(S): We confirmed research that artificial intelligence methods have the potential to accelerate prediction, especially for the possible consequences of COVID-19 on the nervous system.Copyright © 2020 Neuroendocrinology Letters

Accommodating ''History Effects'' in Long Duration, Multisite Clinical Trials to Ensure Relevant and Compelling Evidence

Over the course of a clinical trial, changes in the practice environment have the potential to reduce internal and external validity and impact change in patient outcomes. Such ''history effects''1 can take the form of changes in standard of care, clinical guidelines and recommendations, new drug/device availability in the marketplace, testing and screening procedures, and, as recently experienced, a global pandemic. Clinical trials conducted over many years are particularly susceptible to history effects. Such effects can impact foundational ability to continue a trial, including clinician equipoise and ability to implement trial interventions, necessitating awareness and action planning. For example, Curtis et al.2 acknowledged challenges with clinical guideline history effects and issued recommendations for addressing them such as consideration of participant wellbeing, stakeholder engagement, safety monitoring, review of guideline and policy changes, and development of rules for protocol changes. This session will explore how four multisite clinical trials conducted with VA Cooperative Studies Program sponsorship and coordination have weathered history effects during prolonged periods of enrollment. Topics to be covered include the implementation of pragmatic designs, monitoring of clinical guidelines, assessing control group treatment conditions, modifying protocols, adjusting quality assurance procedures, refining recruitment pathways, and training site investigators. The speakers, Study Chairs, will describe best practices and provide recommendations for navigating history effects in prolonged multisite clinical trials that can ensure outcomes remain relevant and compelling to inform public health at trial commencement. The CSP 2008/PTXRx study is a pragmatic, randomized, double-blind, placebo-controlled, multicenter clinical trial of Veteran patients with diabetic kidney disease (DKD) examining whether pentoxifylline (PTX), when added to usual care, can delay time to end-stage renal disease or death. Enrollment for the study began in 2019, and it is anticipated that 9 years of follow-up will be required to observe the required number of primary events. Given the long duration of the study, changes in clinical guidelines were anticipated and have occurred, including the approval of new DKD therapies and introduction of a new formula for estimated glomerular filtration rate (eGFR) calculation. In anticipation of these changes, the study design allows for whatever standard of care is extant at any time during the course of the study. PTXR's pragmatic trial design and protocol leverage the VA's research infrastructure and remote platforms allowing the study to be responsive to external changes and to safely continue during a global pandemic. The CSP 596/OPTION study is a randomized, double- blind, multicenter trial of Veteran patients with a first or second recurrent Clostridium difficile infection (CDI) comparing (1) fidaxomicin and (2) vancomycin, followed by a taper and pulse to (3) a standard vancomycin regimen. Since enrollment began in 2016, significant changes in CDI epidemiology and clinical management have impacted the study. The COVID-19 pandemic also resulted in an administrative hold on all trial activity followed by staggered reopening of sites due to variable COVID-19 activity and clinical priorities. Many clinical laboratories switched to algorithms that included free toxin assays in addition to polymerase chain reaction (PCR) tests out of concern for overdiagnosis based on PCR testing alone, reducing the number of potentially enrollable cases. There has been increased empirical vancomycin treatment for recurrent CDI without confirmation by stool testing, a requirement for enrollment, and a recruitment strategy for identifying potential cases. Finally, conflicting clinical guidelines for recurrent CDI has created potential equipoise when considering enrollment. Ongoing educational efforts have been made to clarify the protocol and emphasize the validity of the research question as well as protoco changes to allow safe enrollment and follow-up of participants in the face of the ongoing COVID-19 pandemic. The CSP 2005/VALOR is a phase III randomized, open label, multicenter clinical trial of Veteran patients with operable stage I non-small cell lung cancer that compares stereotactic radiotherapy and anatomic pulmonary resection with a primary outcome measure of overall survival. The study was activated in 2017 and recruitment to the trial has been affected by ongoing changes in public and clinician perceptions about stereotactic radiotherapy and surgery that have interfered with equipoise and willingness of participants to enroll. The study team perpetually addresses this challenge through group conversations with local site investigators, study coordinators, and other research personnel to preserve group equipoise across the study. Since the study's activation, new safety information about stereotactic radiotherapy has emerged necessitating protocol modifications while aiming to preserve internal and external validity. The includes modifying standard operating procedures for the study's centralized quality assurance program that has had to adapt its process to remain contemporary. STARPORT, funded by VA CSRD with CSP collaboration, is a randomized, open label, multicenter clinical trial of Veteran patients with oligorecurrent prostate cancer comparing the effects of standard systemic therapy (SST) alone or with PET-directed local therapy using surgery or radiation. Although enrollment was initiated in 2021, changes are already evident in clinical practice guidelines regarding the use of imaging in workup in this patient population. Shortly before the start of accrual, 18F-DCFPyL PSMA PET/CT received FDA-approval. Consequently, it is being rapidly adopted at the STARPORT VA medical centers and the use of conventional imaging using CT or bone scan prior to PET/CT imaging-part of the original eligibility criteria-quickly is falling out of favor. Furthermore, shortly after the start of enrollment, NCCN guidelines adopted the stance that conventional imaging was no longer required in the setting of PSMA PET/CT imaging, solidifying the transition away from conventional imaging. Thus, the protocol is being amended to remove the requirement for conventional imaging as part of workup for oligorecurrence. In addition, to be generalizable, the study is designed to integrate future PSMA radiotracers that are incorporated into practice as well as changes in SST regimens over the time of the study.

Stereotactic radiosurgery with Cyberknife®: first case in the United Arab Emirates (a case report).

A 64-year-old gentleman was referred to the department of oncology with severe pain in the right ear radiating to the right side of the face. Imaging revealed a large extra-axial expansile lesion, surrounding and encasing the right cavernous sinus extending to the right middle cranial fossa. The patient consulted several neurosurgeons and was recommended stereotactic radiosurgery with Cyberknife® as the best non-invasive modality. The proximity to the critical structures, such as the brainstem, made it challenging for any surgical approach. The patient completed stereotactic radiosurgery with Cyberknife® and is doing well one month after treatment.

Integration of Telemedicine Consultations into a Tertiary Radiation Oncology Department: Predictors of Treatment Yield and Changes in Patient Population Compared to the Pre-Pandemic Era

The COVID-19 pandemic has proven telemedicine to be an efficient and safe method of healthcare delivery with the potential to increase accessibility for underrepresented groups. Given the anticipated permanence of telemedicine in radiation oncology practice, we aimed to understand the demographic and treatment characteristics of patients presenting for consultation via telemedicine, the predictors of patients opting to receive radiation therapy (RT) at our center, and the differences in patient and treatment characteristics compared to 2019, when consultations were exclusively in person. We included all patients who had telemedicine consultations from March 2020 to February 2021. Treatment yield was calculated by dividing the number of patients who ultimately received RT by the total number of consults. New consultations seen in 2019 were reviewed and compared to the telemedicine cohort. Chi-square tests were used to identify differences. From 2020 to 2021, a total of 1,069 patients had telemedicine consultations (86% video, 14% phone). Most (64%) were male. Median age was 63 years. The most common disease sites included genitourinary (GU) (41%), breast (14%), and CNS (9%). Six-hundred forty-five (60%) had private insurance, while 424 (40%) had Medicare/Medicaid. Patients lived a median of 241 miles (IQR 96-481 miles) from the radiation oncology center. Forty-four percent of telemedicine patients ultimately received RT. These patients underwent photon RT (54%), proton RT (35%), brachytherapy (7%), stereotactic radiosurgery (3%), or intraoperative RT (1%). No differences were noted in age, sex, race/ethnicity, or insurance type between patients who did and did not receive RT. Patients who received RT lived closer to the center (median 287 vs. 189 miles, p<0.001). For patients within 100 miles of our center, 58% received RT, compared to only 32% of those who lived at least 500 miles away. Patients with gynecologic (76%) and hematologic (72%) malignancies were most likely to receive RT. Compared to 2019 when all 6,116 patients were seen in person, treatment yield was lower with telemedicine (67% vs. 44%, p<0.001). Telemedicine patients were more likely to be male (56% vs. 64%, P<0.001), white (93% vs. 95.0%, p=0.024), have private insurance (55% vs. 60%, p=0.0053), have a GU malignancy (24% vs. 41%, p<0.001), and live further from the center (median 241 vs. 139 miles, p<0.001). Patients seen in telemedicine consultations lived further away and were less likely to receive RT at our tertiary care radiation oncology center. Telemedicine visits did not appear to improve healthcare access for underrepresented groups. Further analysis is warranted to identify gaps and opportunities in remote care. [ FROM AUTHOR] Copyright of International Journal of Radiation Oncology, Biology, Physics is the property of Pergamon Press - An Imprint of Elsevier Science and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full . (Copyright applies to all s.)

Early-onset symptomatic radiation necrosis after stereotactic radiosurgery in the setting of COVID-19 infection.

In this brief report, we describe the case of a previously healthy 51-year gentleman who was treated with stereotactic radiosurgery to a dose of 12 Gy to a small right-sided vestibular schwannoma. MRI of the brain performed after treatment revealed stable treated disease but subsequently, the patient developed symptomatic COVID-19 based on PCR along with multiple cranial neurologic deficits, including right facial paralysis, hemifacial anesthesia, and anesthesia of the ipsilateral hard palate and tongue. MRI of the brain was repeated and demonstrated radiation necrosis in the adjacent brainstem for which he was treated with Pentoxifylline and Vitamin E, dexamethasone, and Bevacizumab with only partial improvement. The dose-volume metrics of the brainstem from his radiotherapy plan as well as the trajectory of his imaging findings do not match this clinical picture from radiotherapy alone. We review the basic pathogenesis of the inflammatory response to infection from the SARS-CoV-2 virus as well as the pathogenesis of radiation necrosis. Heightened awareness about potential risks with high-dose radiotherapy in patients with symptomatic COVID-19 should be considered.

The Zap-X Radiosurgical System in the Treatment of Intracranial Tumors: A Technical Case Report.

BACKGROUND AND IMPORTANCE: The Zap-X system (Zap Surgical Systems Inc, San Carlos, California) is a radically new surgical robot designed for brain and head and neck radiosurgery. It represents the first new dedicated brain stereotactic radiosurgery platform in almost half a century optimizing the goals of safety, speed, and accuracy. The Zap-X system was used in a required Chinese National Medical Products Administration clinical study. In early January 2020, 2 patients were treated with the Zap-X robot prior to a national COVID-19 lockdown. Both were closely followed via clinical exam and magnetic resonance imaging (MRI) imaging. Prospectively collected data were used to generate this report. CLINICAL PRESENTATION: Two female patients, each harboring either a trigeminal schwannoma or petroclival meningioma, were treated with the Zap-X robot. Respective tumor volumes were 2.60 and 4.02 cm3. A radiation dose of 13 Gy was prescribed to the 50% isodose line. At 8 mo of follow-up, preoperative symptoms were either resolved or stable and MRI imaging demonstrated a 31% and 56% reduction in lesion volume, respectively. In both patients, symptoms improved, and tumor volumes decreased, whereas no major complication was observed. CONCLUSION: Given only 2 patients and short-term follow-up, any conclusions about the safety and efficacy of the Zap-X radiosurgery robot are preliminary. However, in the absence of any other published outcomes to date, this small case series may be of interest to many radiosurgical specialists.

Managing patient flows in radiation oncology during the COVID-19 pandemic : Reworking existing treatment designs to prevent infections at a German hot spot area University Hospital.

PURPOSE: The described work aimed to avoid cancellations of indispensable treatments by implementing active patient flow management practices and optimizing infrastructure utilization in the radiation oncology department of a large university hospital and regional COVID-19 treatment center close to the first German SARS-CoV­2 hotspot region Heinsberg in order to prevent nosocomial infections in patients and personnel during the pandemic. PATIENTS AND METHODS: The study comprised year-to-date intervention analyses of in- and outpatient key procedures, machine occupancy, and no-show rates in calendar weeks 12 to 19 of 2019 and 2020 to evaluate effects of active patient flow management while monitoring nosocomial COVID-19 infections. RESULTS: Active patient flow management helped to maintain first-visit appointment compliance above 85.5%. A slight appointment reduction of 10.3% daily (p = 0.004) could still significantly increase downstream planning CT scheduling (p = 0.00001) and performance (p = 0.0001), resulting in an absolute 20.1% (p = 0.009) increment of CT performance while avoiding overbooking practices. Daily treatment start was significantly increased by an absolute value of 18.5% (p = 0.026). Hypofractionation and acceleration were significantly increased (p = 0.0043). Integrating strict testing guidelines, a distancing regimen for staff and patients, hygiene regulations, and precise appointment scheduling, no SARS-CoV­2 infection in 164 tested radiation oncology service inpatients was observed. CONCLUSION: In times of reduced medical infrastructure capacities and resources, controlling infrastructural time per patient as well as optimizing facility utilization and personnel workload during treatment evaluation, planning, and irradiation can help to improve appointment compliance and quality management. Avoiding recurrent and preventable exposure to healthcare infrastructure has potential health benefits and might avert cross infections during the pandemic. Active patient flow management in high-risk COVID-19 regions can help Radiation Oncologists to continue and initiate treatments safely, instead of cancelling and deferring indicated therapies.