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BACKGROUND: Stereotactic arrhythmia radioablation (STAR) is a non-invasive treatment for refractory ventricular tachycardia (VT). OBJECTIVE: This manuscript aimed to systematically review prospective trials on STAR and pool harmonized outcome measures in a meta-analysis. METHODS: Following registration in PROSPERO (CRD42023439666), MEDLINE, Embase, Web of Science, CENTRAL, and Google Scholar were searched on 2023-09-11 to identify reports describing results of prospective trials evaluating STAR for VT. Risk of bias was assessed using the ROBINS-I tool. Meta-analysis was performed using generalised linear mixed models. RESULTS: We identified ten prospective trials in which 82 patients were treated with STAR between 2016 and 2022. The 90-day rate of treatment-related grade ≥3 adverse events was 0.10 (95%CI: 0.04-0.2). The proportions of patients achieving given VT burden reductions were 0.61 (95%CI: 0.45-0.74) for ≥95%, 0.80 (95%CI: 0.62-0.91) for ≥75%, and 0.9 (95%CI: 0.77-0.96) for ≥50% in 63 evaluable patients. The one-year overall survival rate was 0.73 (95%CI: 0.61-0.83) in 81 patients, one-year freedom from recurrence was 0.30 (95%CI: 0.16-0.49) in 61 patients, and one-year recurrence-free survival was 0.21 in 60 patients (95%CI: 0.08-0.46). Limitations include methodological heterogeneity across studies and moderate to significant risk of bias. CONCLUSIONS: STAR is a promising treatment method, characterized by moderate toxicity. We observed one-year mortality of approximately 27% in this population of critically ill patients suffering from refractory VT. Most patients experience a significant reduction in VT burden; however, one-year recurrence rates are high. STAR should still be considered an investigational approach, and recommended to patients primarily within the context of prospective trials.
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This preliminary ethical appraisal from the STOPSTORM.eu consortium is meant to raise critical points that clinicians administering stereotactic arrhythmia radioablation should consider to meet the highest standards in medical ethics and thus promote quality of life of patients recruited for radiotherapy treatments at a stage in which they experience a significant degree of vulnerability.
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BACKGROUND: Stereotactic arrhythmia radioablation (STAR) is delivered with a planning target volume (PTV) prescription dose of 25 Gy, mostly to the surrounding 75-85% isodose line. This means that the average and maximum dose received by the target is less than 35 Gy, which is the minimum threshold required to create a homogenous transmural fibrosis. Similar to catheter ablation, the primary objective of STAR should be transmural fibrosis to prevent heterogenous intracardiac conduction velocities and the occurrence of sustained ventricular arrhythmias (sVA) caused by reentry. We hypothesize that the current dose prescription used in STAR is inadequate for the long-term prevention of sVA and that a significant increase in dose is necessary to induce transmural scar formation. OBJECTIVE: A single arm, multi-center, phase II, dose escalation prospective clinical trial employing the i3 + 3 design is being conducted to examine the safety of a radiation dose-escalation strategy aimed at inducing transmural scar formation. The ultimate objective of this trial is to decrease the likelihood of sVA recurrence in patients at risk. METHODS: Patients with ischemic or non-ischemic cardiomyopathy and recurrent sVA, with an ICD and history of ≥ 1 catheter ablation for sVA will be included. This is a prospective, multicenter, one-arm, dose-escalation trial utilizing the i3 + 3 design, a modified 3 + 3 specifically created to overcome limitations in traditional dose-finding studies. A total of 15 patients will be recruited. The trial aims to escalate the ITV dose from 27.0 Gy to an ITV prescription dose-equivalent level of maximum 35.1 Gy by keeping the PTV prescription dose constant at 25 Gy while increasing the dose to the target (i.e. the VT substrate without PTV margin) by step-wise reduction of the prescribing isodose line (85% down to 65%). The primary outcome of this trial is safety measured by registered radiation associated adverse events (AE) up to 90 days after study intervention including radiation associated serious adverse events graded as at least 4 or 5 according to CTCAE v5, radiation pneumonitis or pericarditis requiring hospitalization and decrease in LVEF ≥ 10% as assessed by echocardiography or cardiac MRI at 90 days after STAR. The sample size was determined assuming an acceptable primary outcome event rate of 20%. Secondary outcomes include sVA burden at 6 months after STAR, time to first sVA recurrence, reduction in appropriate ICD therapies, the need for escalation of antiarrhythmic drugs, non-radiation associated safety and patient reported outcome measures such as SF-36 and EQ5D. DISCUSSION: DEFT-STAR is an innovative prospective phase II trial that aims to evaluate the optimal radiation dose for STAR in patients with therapy-refractory sVA. The trial has obtained IRB approval and focuses on determining the safe and effective radiation dose to be employed in the STAR procedure. TRIAL REGISTRATION: NCT05594368.
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Radiocirugia , Taquicardia Ventricular , Humanos , Estudios Prospectivos , Cicatriz/etiología , Cicatriz/cirugía , Radiocirugia/efectos adversos , Radiocirugia/métodos , Taquicardia Ventricular/radioterapia , Taquicardia Ventricular/cirugía , Taquicardia Ventricular/etiología , CorazónRESUMEN
BACKGROUND AND PURPOSE: Despite its increasing popularity, there are limited prospective data on stereotactic arrhythmia radioablation (STAR). In this trial, we assessed the safety and efficacy of STAR in patients with ventricular tachycardia (VT), focusing on early treatment-related grade ≥ 3 adverse events (AE). MATERIALS AND METHODS: This prospective trial was designed for adults with VT recurrence following catheter ablation (CA) despite adequate pharmacotherapy, or contraindications to CA. A single dose of 25 Gy was delivered to the arrhythmia substrate defined on electro-anatomic mapping and cardiac-gated CT. The primary endpoint was safety, defined as two or fewer treatment-related grade ≥ 3 AEs during the first three months in 11 patients. Additional endpoints included treatment efficacy, clinical and biological markers of cardiac injury, and quality of life. RESULTS: Eleven patients with a median age of 67 years, structural heart disease, and a clinically significant recurrence of VT despite adequate pharmacotherapy and 1-4 previous CAs were enrolled between 2020/09 and 2022/10. Following the treatment, one patient developed a possibly treatment-related grade ≥ 3 AE, a grade 4 heart failure exacerbation at 87 days, which resolved after conservative treatment. There was a total 84.3% reduction in VT burden in 10 evaluable patients; however, VT recurrence was eventually observed in eight, and three patients required additional CAs. Three deaths due to unrelated causes were recorded. CONCLUSIONS: STAR appears to be safe and efficient. It is a promising treatment for selected patients; however, long-term outcomes remain to be evaluated, and controlled trials comparing STAR with standards of care are missing.
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An analysis of patients below 21 years old treated due to craniopharyngioma in the years 1979-2022 was performed with the aim of evaluating the long-term outcome and treatment side-effects. The standard statistical tests were used, and 56 patients with a median age of 11 years were evaluated. Surgery was the primary treatment in 55 patients; however, in only 29 it was the only neurosurgical intervention. Eighteen children were treated with radiotherapy (RTH) in primary treatment. The most common neurosurgical side effects observed were visual and endocrine deficits and obesity, which were diagnosed in 27 (49%), 50 (91%), and 25 (52%) patients, respectively. Complications after RTH were diagnosed in 14 cases (32%). During the median follow-up of 8.4 years (range: 0.4-39.8 years), six patients died and the 5- and 10-year overall survival was 97% and 93%, respectively. Five-year progression-free survival for gross total resection, resection with adjuvant RTH, and non-radical resection alone was 83%, 68%, and 23%, respectively (p = 0.0006). Surgery combined with RTH provides comparable results to gross tumor resection in terms of oncologic outcome in craniopharyngioma patients. Adjuvant irradiation applied in primary or salvage treatment improves disease control. The rate of complications is high irrespective of improved surgical and radiotherapeutic management.
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The EU Horizon 2020 Framework-funded Standardized Treatment and Outcome Platform for Stereotactic Therapy Of Re-entrant tachycardia by a Multidisciplinary (STOPSTORM) consortium has been established as a large research network for investigating STereotactic Arrhythmia Radioablation (STAR) for ventricular tachycardia (VT). The aim is to provide a pooled treatment database to evaluate patterns of practice and outcomes of STAR and finally to harmonize STAR within Europe. The consortium comprises 31 clinical and research institutions. The project is divided into nine work packages (WPs): (i) observational cohort; (ii) standardization and harmonization of target delineation; (iii) harmonized prospective cohort; (iv) quality assurance (QA); (v) analysis and evaluation; (vi, ix) ethics and regulations; and (vii, viii) project coordination and dissemination. To provide a review of current clinical STAR practice in Europe, a comprehensive questionnaire was performed at project start. The STOPSTORM Institutions' experience in VT catheter ablation (83% ≥ 20 ann.) and stereotactic body radiotherapy (59% > 200 ann.) was adequate, and 84 STAR treatments were performed until project launch, while 8/22 centres already recruited VT patients in national clinical trials. The majority currently base their target definition on mapping during VT (96%) and/or pace mapping (75%), reduced voltage areas (63%), or late ventricular potentials (75%) during sinus rhythm. The majority currently apply a single-fraction dose of 25 Gy while planning techniques and dose prescription methods vary greatly. The current clinical STAR practice in the STOPSTORM consortium highlights potential areas of optimization and harmonization for substrate mapping, target delineation, motion management, dosimetry, and QA, which will be addressed in the various WPs.
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Ablación por Catéter , Taquicardia Ventricular , Humanos , Estudios Prospectivos , Arritmias Cardíacas , Ventrículos Cardíacos , Ablación por Catéter/efectos adversos , Ablación por Catéter/métodos , Resultado del TratamientoRESUMEN
70-kDa Heat Shock Proteins (HSPA/HSP70) are chaperones playing a central role in the proteostasis control mechanisms. Their basal expression can be highly elevated as an adaptive response to environmental and pathophysiological stress conditions. HSPA2, one of poorly characterised chaperones of the HSPA/HSP70 family, has recently emerged as epithelial cells differentiation-related factor. It is also commonly expressed in cancer cells, where its functional significance remains unclear. Previously, we have found that proteotoxic stress provokes a decrease in HSPA2 levels in cancer cells. In the present study we found that proteasome inhibition-related loss of HSPA2 from cancer cells neither is related to a block in the gene transcription nor does it relate to increased autophagy-mediated disposals of the protein. Proteotoxic stress stimulated extracellular release of HSPA2 in extracellular vesicles (EVs). Interestingly, EVs containing HSPA2 are also released by non-stressed cancer and normal cells. In human urinary EVs levels of HSPA2 were correlated with the levels of TSG101, one of the main EVs markers. We conclude that HSPA2 may constitute basic components of EVs. Nevertheless, its specific role in EVs and cell-to-cell communication requires further investigation.
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Vesículas Extracelulares , Neoplasias , Humanos , Proteínas de Choque Térmico/genética , Proteínas HSP70 de Choque Térmico/metabolismo , Chaperonas Moleculares/metabolismo , Vesículas Extracelulares/metabolismoRESUMEN
Splenomegaly is a hallmark of myelofibrosis, a debilitating haematological malignancy for which the only curative option is allogeneic haematopoietic cell transplantation (HCT). Considerable splenic enlargement might be associated with a higher risk of delayed engraftment and graft failure, increased non-relapse mortality, and worse overall survival after HCT as compared with patients without significantly enlarged splenomegaly. Currently, there are no standardised guidelines to assist transplantation physicians in deciding optimal management of splenomegaly before HCT. Therefore, the aim of this Position Paper is to offer a shared position statement on this issue. An international group of haematologists, transplantation physicians, gastroenterologists, surgeons, radiotherapists, and radiologists with experience in the treatment of myelofibrosis contributed to this Position Paper. The key issues addressed by this group included the assessment, prevalence, and clinical significance of splenomegaly, and the need for a therapeutic intervention before HCT for the control of splenomegaly. Specific scenarios, including splanchnic vein thrombosis and COVID-19, are also discussed. All patients with myelofibrosis must have their spleen size assessed before allogeneic HCT. Myelofibrosis patients with splenomegaly measuring 5 cm and larger, particularly when exceeding 15 cm below the left costal margin, or with splenomegaly-related symptoms, could benefit from treatment with the aim of reducing the spleen size before HCT. In the absence of, or loss of, response, patients with increasing spleen size should be evaluated for second-line options, depending on availability, patient fitness, and centre experience. Splanchnic vein thrombosis is not an absolute contraindication for HCT, but a multidisciplinary approach is warranted. Finally, prevention and treatment of COVID-19 should adhere to standard recommendations for immunocompromised patients.
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COVID-19 , Trasplante de Células Madre Hematopoyéticas , Leucemia Mieloide Aguda , Mielofibrosis Primaria , Trombosis , Humanos , Esplenomegalia/etiología , Mielofibrosis Primaria/complicaciones , Mielofibrosis Primaria/terapia , COVID-19/complicaciones , Leucemia Mieloide Aguda/terapia , Trombosis/complicaciones , Acondicionamiento PretrasplanteRESUMEN
Cardiac stereotactic body radiotherapy is an emerging treatment method for recurrent ventricular tachycardia refractory to invasive treatment methods. The single-fraction delivery of 25 Gy was assumed to produce fibrosis, similar to a post-radiofrequency ablation scar. However, the dynamics of clinical response and recent preclinical findings suggest a possible different mechanism. The data on histopathological presentation of post-radiotherapy hearts is scarce, and the authors provide significantly different conclusions. In this article, we present unique data on histopathological examination of a heart explanted from a patient who had a persistent anti-arrhythmic response that lasted almost a year, until a heart failure exacerbation caused a necessity of a heart transplant. Despite a complete treatment response, there was no homogenous transmural fibrosis in the irradiated region, and the overall presentation of the heart was similar to other transplanted hearts of patients with advanced heart failure. In conclusion, our findings support the theorem of functional changes as a source of the anti-arrhythmic mechanism of radiotherapy and show that durable treatment response can be achieved in absence of transmural fibrosis of the irradiated myocardium.
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Background: Stereotactic Arrhythmia Radioablation (STAR) is an emerging treatment modality for patients with sustained ventricular tachycardia (VT) and refractory to treatment with drugs and radiofrequency catheter ablation (RFA). It is believed that up to 12-17% of patients experience recurrence of VT within 1 year of follow-up; thus, novel therapeutic options are needed. The aim of this article is to present initial experience within a novel treatment modality for VT. Case Summary: Two patients with a medical history of coronary artery disease and heart failure with reduced left ventricle (LV) ejection fraction, after implantation of cardioverter-defibrillator (ICD) and previous unsuccessful RFAs owing to sustained VT were admitted to the cardiology department due to recurrence of sustained VT episodes. With electroanatomical mapping (EAM), the VT substrate in LV has been confirmed and specified. In order to determine the target volume for radioablation, contrast-enhanced computed tomography was performed and the arrhythmia substrate was contoured using EAM data. Using the Volumetric Modulated Arc Therapy technique and three 6 MeV flattening filter-free photon beam fields, a single dose of 25 Gy was delivered to the target volume structure located in the apex and anterior apical segments of LV in the first patient and in the apex, anterolateral and inferior apical segments of the second patient. In both cases, volumes of the target structures were comparable. Interrogation of the implanted ICD at follow-up visits throughout 6 months after the treatment revealed no VT episodes in the first patient and sudden periprocedural increase in VT burden with a subsequent gradual decrease of ventricular arrhythmia to only two non-sustained episodes at the end of the follow-up period in case of the second patient. A significant reduction in premature ventricular contractions burden was observed compared to the pre-treatment period. No noticeable deterioration in LV function was noted, nor any adverse effects of radiosurgery associated with the implanted device. Conclusion: The early response to STAR can be unpredictable and probably does not reflect the final outcome of irradiation. Close monitoring of patients, especially in the early period after irradiation is crucial to properly handle potentially harmful early reactions to STAR.
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BACKGROUND: The aim of the study was to assess the results of stereotactic radiosurgery and hypofractionated stereotactic radiotherapy (SRS/SRT) for skull base chordomas. MATERIALS AND METHODS: Twenty-three patients aged 12-75 were treated with SRS/SRT due to skull base chordoma. In 19 patients SRS/SRT was a part of the primary therapy, while in 4, a part of the treatment of recurrence. In 4 patients SRS/SRT was used as a boost after conventional radiotherapy and in 19 cases it was the only irradiation method applied. Patients were irradiated to total dose of 6-35 Gy and median total equivalent dose of 52 Gy. RESULTS: During median follow-up of 39 months, 4 patients died. One-, two- and five-year OS was 95%, 89% and 69%, respectively. In nine patients, progression of the disease was diagnosed during study period. One-, two- and five-year progression free survival (PFS) from the end of radiotherapy was 81%, 59% and 43%, respectively. Radiotherapy was well tolerated and only two patients in our group experienced moderate treatment-related toxicity. CONCLUSION: SRS/SRT alone or in combination with surgery is a safe and effective method of irradiation of patients with skull base chordomas. High EQD2 is necessary to achieve satisfactory treatment results.
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The study aimed to analyze potential prognostic factors in patients treated with robotic radiosurgery for brain metastases irrespective of primary tumor location and create a simple prognostic score that can be used without a full diagnostic workup. A retrospective analysis of 142 patients with 1-9 brain metastases treated with stereotactic radiosurgery (1-4 fractions) was performed. Volumes of all lesions were calculated using linear dimensions of the tumors (CC, LR, AP) and 4/3*π*(CC/2)*(LR/2)*(AP/2) formula. Kaplan-Meier method and log-rank test were used to analyze survival. Variables significantly associated with overall survival in univariate analysis were included in Cox multivariate analysis. The validity of the model was tested with the bootstrap method. Variables from the final model were used to construct a new prognostic index by assigning points according to the impact of a specific variable on overall survival. In the multivariate analysis, four factors: Karnofsky Performance Status (p = 0.000068), number of brain metastases (p = 0.019), volume of the largest lesion (p = 0.0037), and presence of extracerebral metastases (p = 0.0017), were independent predictors of survival. Total scores ranged from 0 to 12 points, and patients were divided into four groups based on median survival of each subgroup: 0-1 points-18.8 months, 2-3 points-16.9 months, 4-5 points-5.6 months, and ≥ 6 points-4.9 months (p < 0.001). The new prognostic index is simple to calculate. It has a strong prognostic value in a heterogeneous population of patients with a various number of brain metastases, but its value requires confirmation in another cohort.
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Neoplasias Encefálicas , Radiocirugia , Robótica , Adulto , Anciano , Anciano de 80 o más Años , Neoplasias Encefálicas/mortalidad , Neoplasias Encefálicas/patología , Neoplasias Encefálicas/radioterapia , Neoplasias Encefálicas/secundario , Supervivencia sin Enfermedad , Femenino , Estudios de Seguimiento , Humanos , Masculino , Persona de Mediana Edad , Metástasis de la Neoplasia , Estudios Retrospectivos , Tasa de SupervivenciaRESUMEN
The electrophysiology-guided noninvasive cardiac radioablation, also known as STAR (stereotactic arrhythmia radioablation) is an emerging treatment method for persistent ventricular tachycardia. Since its first application in 2012 in Stanford Cancer Institute, and a year later in University Hospital Ostrava, Czech Republic, the authors from all around the world have published case reports and case series, and several prospective trials were established. In this article, we would like to discuss the available clinical evidence, analyze the potentially clinically relevant differences in methodology, and address some of the unique challenges that come with this treatment method.
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BACKGROUND: Cardiovascular diseases are the most common factor affecting prognosis in cancer survivors. Cardiooncology (CO) services have been developed to solve this issue. The outcomes regarding patient demographics and clinical findings are limited and the available data include CO services evaluating patients undergoing only chemotherapy as opposed to those also undergoing radiation therapy. AIMS: We aimed to show initial experiences of the CO service implemented in a tertiary oncology center. METHODS: The CO service was designed to include 2 major domains, general CO and electrotherapy consultations. This observational study included patients referred to the CO service with the following data: baseline demographics, cancer type, reasons for referral, cardiac evaluation, and initial clinical outcomes. RESULTS: All patients with cancer referred to our CO service between March 2016 and December 2019 were included in the study. A total of 2762 patients (77% women) at the mean (SD) age of 62 (12) years were referred (63% on an outpatient basis) for general consultations. The most frequent diagnosis was breast cancer (66%). A total of 18% of patients were referred to the CO service due to cardiovascular complications related to cancer treatment. The CO-cardiac implantable electronic device (CIED) team evaluated 652 patients (515 patients with CIEDs who were qualified for radiotherapy, 48 patients with CIEDs who were assessed with magnetic resonance imaging, and 89 patients with CIEDs who underwent cancer surgery). In the total of 5872 radiotherapy sessions, there were 2 harmful interactions; no other complications during magnetic resonance imaging and surgery were recorded. CONCLUSIONS: The COservice established within the cancer center seems to be safe and feasible.
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Desfibriladores Implantables , Cardiopatías , Neoplasias , Marcapaso Artificial , Oncología por Radiación , Femenino , Cardiopatías/terapia , Humanos , Masculino , Persona de Mediana Edad , Neoplasias/complicaciones , Neoplasias/terapiaRESUMEN
The goal of this phase II trial was to evaluate safety and efficacy of a tandem autologous hematopoietic cell transplantation (auto-HCT) using sequentially total marrow irradiation (TMI) at the dose of 12 Gy (4 Gy on days -3, -2, and -1) and melphalan 200 mg/m2 for patients with multiple myeloma (MM). TMI was performed using helical tomotherapy. Additional "boosts" (total 24 Gy) were applied for patients with active lesions as revealed by PET-FDG. Fifty patients with median age 58 years (41-64 years) were included and received tandem auto-HCT. TMI resulted in absolute neutropenia in all patients. Grade 3 infections were reported in 30% patients. Other toxicities were rare. Proportion of patients who achieved at least very good partial response increased from 46% before the first auto-HCT to 82% after tandem transplantation. Complete remission rates changed from 10% to 42%, respectively. The probabilities of overall and progression-free survival at 5 years were 74% and 55%, respectively. No patient died without progression. We conclude that conditioning with TMI ± PET-guided "boosts" represents personalized treatment approach in MM and is characterized by very good toxicity profile. Tandem auto-HCT using TMI in sequence with high-dose melphalan appears safe with encouraging early efficacy.
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Trasplante de Células Madre Hematopoyéticas , Mieloma Múltiple , Adulto , Médula Ósea , Humanos , Melfalán , Persona de Mediana Edad , Mieloma Múltiple/terapia , Acondicionamiento Pretrasplante , Trasplante Autólogo , Resultado del TratamientoRESUMEN
BACKGROUND: The number of patients with cardiac implantable electronic devices (CIEDs) treated with radiation therapy (RT) as an oncological treatment is expected to increase. AIMS: The aim of the study was to assess whether cancer treatment with radiation therapy is associated with any device dysfunctions and devicerelated threats in patients with CIEDs. METHODS: The risk of all patients with CIEDs undergoing RT was assessed according to guidelines. Device interrogations were performed before the first and after the last RT session. In patients at high risk and/or with an implantable cardioverterdefibrillator or cardiac resynchronization therapy with defibrillator (CRTD), all sessions were supervised by a cardiologist, and device interrogations were performed before and after every single RT session. Device parameters and events were monitored during thewhole treatment. RESULTS: The study included 157 patients with CIEDs who had palliative (n = 71) or radical (n = 86) RT. Pacemakers were implanted in 113 patients, implantable cardioverterdefibrillators in 36, and CRTD in 8. During the 2396 RT sessions (median [interquartile range], 5 [5-28] per patient) with cumulative dose up to 78 Gy per patient for the whole RT treatment and maximum energy beam up to 20 MV, 2 events potentially related to radiation were recorded. CONCLUSIONS: Radiation therapy in patients with CIEDs is not associated with substantial risk to the patients assuming the patients' management follows current guidelines.
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Terapia de Resincronización Cardíaca , Desfibriladores Implantables , Neoplasias , Marcapaso Artificial , Electrónica , HumanosRESUMEN
This study provides the first insight into the problem of the induced radioactivity of the construction materials of the new-generation cardiac implantable electronic devices (CIEDs). Its aim was to identify nuclear reactions and the resulting radioisotopes induced in the CIEDs by high-energy X-ray therapeutic beams generated by medical linear accelerators. The presented results allow to verify the rightness of choice of materials for investigated CIEDs. Such analysis is currently available only for the older types of the CIEDs, but not for those of the new generation. Gamma spectrometry measurements have been performed using a high-purity germanium detector (HPGe). The identification and activities of the generated radioisotopes were obtained from the measured spectra of gamma - rays from decays of the produced unstable radioisotopes. 21 radioisotopes originating from 24 nuclear reactions were identified. For all considered models of CIEDs the highest activities are from the tin isomer 117mSn. The induced activities were relatively small, not exceeding 3.1 Bq per a 1 Gy X-ray dose to a target volume.