Radiotherapy for patient with cardiac implantable electronic device, consensus from French radiation oncology society.

Radiotherapy in patients with cardiac implantable electronic device such as pacemakers or defibrillators, is a clinical situation that is becoming increasingly common. There is a risk of interaction between the magnetic field induced by accelerators and the cardiac implantable electronic device, but also a risk of device dysfunction due to direct and/or indirect irradiation if the cardiac implantable electronic device is in the field of treatment. The risk can be dose-dependent, but it is most often independent of the total dose and occurs randomly in case of neutron production (stochastic effect). The presence of this type of device is therefore described as a contraindication for radiotherapy by the French national agency for the safety of medicines and health products (Agence nationale de sécurité du médicament et des produits de santé, ANSM). Nevertheless, since radiotherapy is often possible, it is advisable to respect the recommendations of good practice, in particular the eligibility criteria, the monitoring modalities before, during and after irradiation according to the type of treatment, the dose and the characteristics of the cardiac implantable electronic device. It is sometimes necessary to discuss repositioning the device and/or modifying the treatment plan to minimize the risk of cardiac implantable electronic device dysfunction. We present the update of the recommendations of the French society of oncological radiotherapy on in patients with cardiac implantable electronic device.

The safety of bipolar mode radiofrequency (BMRF) on cochlear implant integrity test; a clinical prospective study.

PURPOSE: We aimed to assess the effect of bipolar mode radiofrequency (BMRF) tonsillectomy as a model of oro-pharyngeal surgical maneuver on the integrity of the internal device in patients with cochlear implants (CIs). MATERIALS AND METHODS: This prospective case series included 15 consecutive pediatric patients with CIs (age range 4 to 8 years, mean 5.2 years) who underwent BMRF tonsillectomy. The postoperative integrity of the internal device was evaluated by comparing the electric current response tested preoperatively with that tested 2 days postoperatively. RESULTS: There were differences in the current levels in the main regions of the cochlea; (the apical, mid-turn, and basal) after comparing preoperative and postoperative values, but they were not statically significant. CONCLUSION: BMRF seems to be safe for tonsillectomy in children with CIs without negative impact on the integrity of the internal device.

Patients with cardiac implantable electronic devices undergoing radiotherapy in Poland. Expert opinion of the Heart Rhythm Section of the Polish Cardiac Society and the Polish Society of Radiation Oncology.

Older age and high morbidity of the society contribute to a growing number of patients with cardiac implantable electronic devices (CIEDs) requiring effective cancer treatment, including radiotherapy (RT). The effect of RT on a CIED may vary depending on the type and physical parameters of radiation, location of the treated lesion, indications for electrotherapy, and the type of CIED. In the most dramatic scenarios, it may cause an irreversible damage to the CIED, with serious clinical consequences. The lack of precise guidelines may limit the access to RT for many patients with CIEDs who would otherwise benefit from the therapy or may lead to a therapy without taking the necessary precautions, which may worsen the prognosis. Therefore, clear and unequivocal recommendations for assessing patient eligibility for RT are aimed at ensuring that adequate precautions are taken as well as at providing patients with concomitant cardiovascular and oncologic diseases with access to safe and effective RT.

Middle term results of tantalum acetabular cups in total hip arthroplasty following pelvic irradiation.

OBJECTIVES: The aim of this study was to evaluate the middle term cup survival, assess the functional implementation and the radiographic evolution of tantalum acetabular cups implanted on patients with a history of pelvic radiotherapy. METHODS: From 2005 to 2013, we performed 12 THA replacements (4 males 8 females; mean age: 46.6 years (range 25-75)) on irradiated bone with Trabecular metal acetabular cups, 8 primary implants and 4 revision implants. The mean radiation dose delivered was 5500 cGy (range 3000 cGy-13,600 cGy). The mean follow-up was 68 months, ranging from 38 to 136. Postoperative follow-up time was assessed at 1, 3, 6 and 12 months, then annually. Double projection radiographs were requested at each control. Radiographic signs of loosening were investigated by X-rays looking for radiolucent lines. We used the Harris hip score for the clinical and functional evaluation. RESULTS: To now none of the 12 patients in the series needed any revision surgery for aseptic loosening. In the revision group one patient have been revised for septic loosening, two patients have been treated by conservative procedure for hip dislocation. Post-operative Harris hip score improved from an average of 46 points to 85.3 points. At last follow-up we found only in one case radiographic signs of progressive lucent line, without clinical sign of failure. CONCLUSION: In a clinical setting, tantalum cup seems to provide a good stability due to the integration of the trabecular metal to the underline cancellous bone. The reported results, in agreement with literature data, propose the use of tantalum cups in irradiated bone. LEVEL OF EVIDENCE: Level IV, therapeutic study.

Radiotherapy in patients with cardiac implantable electronic devices: clinical and dosimetric aspects.

As a result of aging, the number of patients with cardiac implantable electronic device (CIED) requiring radiotherapy (RT) continues to rise. The aim of this work was to evaluate RT-related malfunctions of CIED in a cohort of patients who underwent RT in our clinic from June 2010 to December 2016. We retrospectively analyzed 93 RT treatments in 63 patients with CIEDs. Patients were treated with 3D conformal RT, intensity-modulated RT and stereotactic RT. We collected clinical characteristics of cancer, models of CIEDs, total RT dose to tumor and radiation energy. Radiation dose delivered to CIED and its dysfunctions after RT was evaluated. Subgroup analysis of 48 RT treatments (32 patients) on chest and neck plus on 13 RT treatments (12 patients) with 18 MV neutron-producing photon energy considered as high risk was performed. The number of treatments of patients with CIEDs increased from 0.3% in 2011 to 1.2% in 2016. Two patients, treated with 18 MV photon beam, with implantable cardioverter-defibrillators (ICDs) that received a maximum dose of around 2.1 Gy, experienced adverse events: a reprogramming of ICD when the patient reached a delivered dose to the tumor of 32 Gy, and an altered sensing function requiring replacement after 11 months from the end of RT. Nearly 2% of patients with CIEDs from high-risk patients subgroup had experienced a damage of the device. Close cooperation between radiation oncologists, cardiologists, medical physicists and radiation technologists is needed to achieve the best practice management in these patients.

Prior Radiation Therapy Decreases Time to Idiopathic Erosion of Artificial Urinary Sphincter: A Multi-Institutional Analysis.

PURPOSE: Substantial controversy and conflicting data exist regarding the survival of the artificial urinary sphincter in patients with prior radiation therapy. We present data from a multi-institutional analysis examining the effect of prior radiation for prostate cancer on device survival. MATERIALS AND METHODS: A database was compiled of patients with artificial urinary sphincter cuff erosion, which included demographic and comorbid patient characteristics, functional analyses and interventions. We identified 80 patients with iatrogenic or idiopathic artificial urinary sphincter erosion. Idiopathic erosion cases were further analyzed to determine factors influencing device survival with specific stratification for radiation therapy. RESULTS: A total of 56 patients were identified with idiopathic artificial urinary sphincter erosion. Of those men 33 (58.9%) had not undergone radiation treatment while 23 (41.1%) had a history of brachytherapy or external beam radiotherapy. In patients without radiation erosion-free median device survival was 3.15 years (95% CI 1.95-5.80), in contrast to the median device survival of only 1.00 year (95% CI 0.36-3.00) in irradiated patients. The erosion-free survival experience of patients with vs without radiation differed significantly (Wilcoxon-Breslow test for equality of survivor functions p = 0.03). CONCLUSIONS: Radiation therapy in patients with known idiopathic cuff erosion in this contemporary analysis correlated with significantly increased time to erosion. Mean time to idiopathic cuff erosion was accelerated by approximately 2 years in irradiated cases. To our knowledge these data represent the first demonstration of substantial outcome differences associated with radiation in patients with an artificial urinary sphincter who present specifically with cuff erosion.

What Is the Optimum Timing of Postmastectomy Radiotherapy in Two-Stage Prosthetic Reconstruction: Radiation to the Tissue Expander or Permanent Implant?

BACKGROUND: Postmastectomy radiotherapy is increasingly common for patients with advanced breast cancer. The optimal timing and sequence of mastectomy, reconstruction, and radiotherapy remains unresolved for patients choosing immediate two-stage prosthetic reconstruction. METHODS: Long-term outcomes were compared for all patients with prosthetic-based reconstruction without radiation, radiation to the tissue expander, or to the permanent implant from 2003 to 2012 performed by the senior author (P.G.C.). Surgeon-evaluated outcomes included reconstructive failure, aesthetic results, and capsular contracture. Odds of failure with radiotherapy at different times were evaluated with logistic regression and Kaplan-Meier analysis. Patient-reported outcomes were assessed using the BREAST-Q. RESULTS: A total of 1486 reconstructions without radiation, 94 reconstructions with tissue expander radiation, and 210 reconstructions with permanent implant radiation were included. Six-year predicted failure rates were greater for patients with tissue expander radiation than for patients with permanent implant radiation (32 percent versus 16.4 percent; p < 0.01). Patients undergoing radiation to the tissue expander had a greater proportion of very good to excellent aesthetic results compared to patients with permanent implant radiation (75.0 percent versus 67.6 percent; p < 0.01) and lower rates of grade IV capsular contracture (p < 0.01). BREAST-Q scores were similar for patients with the different radiation timings. CONCLUSIONS: Although the risk of reconstructive failure is significantly higher for patients with tissue expander radiation compared to patients with permanent implant radiation, the aesthetic results and capsular contracture rates are slightly better. Patient reported outcomes do not differ between patients with tissue expander or permanent implant radiation. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, III.

Stability and survival of bone-anchored hearing aid implant systems in post-irradiated patients.

Bone-anchored hearing aids (BAHAs) are based on the principle of osseointegration, which is fundamental to implant stability and survival. Previous exposure to ionising radiation may compromise this, as evidenced in relation to dental and craniofacial implants. There is a dearth of data, however, regarding BAHA implant systems in patients with previously irradiated implant sites. We sought, therefore, to investigate implant stability and survival in such patients. Patients were identified retrospectively from our electronic BAHA database. Hospital records were reviewed for demographics; operative technique; complications; and details regarding previous irradiation. Implant stability was assessed by resonance frequency analysis (RFA), generating a numerical value-implant stability quotient (ISQ). Extrapolating from dental studies, successfully loaded implants typically have ISQs of ≥60. Readings were, therefore, interpreted with respect to this. Seven patients were identified for inclusion. Mean time between irradiation and implant insertion was 33 months (range 16-72 months), and mean time from implant insertion to RFA measurement was 41 months (range 3-96 months). Operatively, all patients underwent single-stage procedures under local anaesthesia. One patient suffered a Holger's grade 2 skin reaction, while two suffered significant skin flap failure, requiring revision procedures. The implant survival rate was 100 %. All ISQ values were >60, with a mean of 66.9 (95 % confidence interval 63.1-70.6). Our data support sufficient osseointegration of BAHA implant systems in post-irradiated patients, but highlight issues with wound healing. Contemporary soft tissue preservation operative techniques will likely overcome this, facilitating safe and efficacious BAHA insertion in this ever-increasing group of patients.

Probabilistic assessment of fatigue initiation data on highly crosslinked ultrahigh molecular weight polyethylenes.

Ultrahigh molecular weight polyethylenes (UHMWPE) showing wear resistance, oxidative stability and good mechanical performance go on being a relevant research area in biomaterials for total joint replacements, where fatigue happens to be a recurrent damage mode that needs to be investigated. While crack propagation lifetime has been extensively studied, fatigue initiation data are scarcely offered in the literature, often due to the higher costs implied in the experimental programs. Moreover, their analysis is not always suitable to obtain reliable guidance. Different deterministic and probabilistic methods, generally resting on empirical bases have been previously used to analyze the fatigue initiation data. In this work, the probabilistic Weibull regression model of Castillo et al., based on both physical and statistical conditions, such as weakest link principle and the necessary compatibility between life-time and stress range distributions, is applied for the first time in the assessment of fatigue results of polymers, particularly to highly crosslinked UHMWPEs (HXLPEs). Accordingly, different published experimental data corresponding to HXLPE stabilized by thermal treatments and with α-tocopherol (vitamin E) are re-analyzed. Additional data are incorporated to assess the influence of notched HXLPE on fatigue performance. New conclusions are drawn from this revision.

Microbial colonization of tracheoesophageal voice prostheses (Provox2) following total laryngectomy.

The purpose of this study was to determine the presence of individual microorganisms and the most frequent microbial combinations in the biofilm of the indwelling Provox2 voice prosthesis in situ. Furthermore, we wanted to evaluate the possible influence of biofilm composition on the mean and median lifetime of these voice prostheses. Over a 5-year period, implantation of a Provox2 voice prosthesis was performed in 85 patients, or 90% of the overall number of patients who underwent total laryngectomy. In total 100 implanted voice prostheses, at least one of every patient, were microbiologically processed immediately after being replaced. Out of the total of 292 isolates, 67% were bacteria and the remaining 33% were yeasts. The most frequently found yeast species on voice prostheses biofilms was C. albicans, followed by C. krusei and C. tropicalis. The most frequently isolated bacteria included Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, Proteus mirabilis, and Streptococcus agalactiae. Simultaneous presence of bacteria and fungi was established in 83% of the processed voice prostheses; in 16% of samples the biofilm contained only one or more bacterial species. The mean time of implantation was 238 days and the median lifetime of the device was 180 days. Dividing the prostheses in four groups according to the composition of biofilm revealed that the device lifetimes varied significantly between groups. The longest lifetime of voice prostheses was associated with the presence of single fungal isolate in combination with bacteria. There is a significant correlation between biofilm composition and the device life time.