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Brachytherapy 2022Precision breast intraoperative radiation therapy (PB-IORT) is a novel approach to adjuvant radiation therapy for early-stage breast cancer performed as part of a phase...
A comparative study using time-driven activity-based costing in single-fraction breast high-dose rate brachytherapy: An integrated brachytherapy suite vs. decentralized workflow.
INTRODUCTION
Precision breast intraoperative radiation therapy (PB-IORT) is a novel approach to adjuvant radiation therapy for early-stage breast cancer performed as part of a phase II clinical trial at two institutions. One institution performs the entire procedure in an integrated brachytherapy suite which contains a CT-on-rails imaging unit and full anesthesia capabilities. At the other, breast conserving surgery and radiation therapy take place in two separate locations. Here, we utilize time-driven activity-based costing (TDABC) to compare these two models for the delivery of PB-IORT.
METHODS
Process maps were created to describe each step required to deliver PB-IORT at each institution, including personnel, equipment, and supplies. Time investment was estimated for each step. The capacity cost rate was determined for each resource, and total costs of care were then calculated by multiplying the capacity cost rates by the time estimate for the process step and adding any additional product costs.
RESULTS
PB-IORT costs less to deliver at a distributed facility, as is more commonly available, than an integrated brachytherapy suite ($3,262.22 vs. $3,996.01). The largest source of costs in both settings ($2,400) was consumable supplies, including the brachytherapy balloon applicator. The difference in costs for the two facility types was driven by personnel costs ($1,263.41 vs. $764.89). In the integrated facility, increased time required by radiation oncology nursing and the anesthesia attending translated to the greatest increases in cost. Equipment costs were also slightly higher in the integrated suite setting ($332.60 vs. $97.33).
CONCLUSIONS
The overall cost of care is higher when utilizing an integrated brachytherapy suite to deliver PB-IORT. This was primarily driven by additional personnel costs from nursing and anesthesia, although the greatest cost of delivery in both settings was the disposable brachytherapy applicator. These differences in cost must be balanced against the potential impact on patient experience with these approaches.
Topics: Brachytherapy; Breast Neoplasms; Female; Humans; Mastectomy, Segmental; Workflow
PubMed: 35125328
DOI: 10.1016/j.brachy.2021.12.006 -
Technology in Cancer Research &... Jun 2017The efficacy of image-guided high-dose rate brachytherapy for cervical cancer is limited by the ineffective rectal sparing devices available commercially and the...
PURPOSE
The efficacy of image-guided high-dose rate brachytherapy for cervical cancer is limited by the ineffective rectal sparing devices available commercially and the potential applicator movement. We developed a novel device using a balloon catheter and a belt immobilization system, serving for rectal dose reduction and applicator immobilization purposes, respectively.
METHODS
The balloon catheter is constructed by gluing a short inflatable tube to a long regular open-end catheter. Contrast agent (10) cm is injected into the inflatable end, which is affixed to the tandem and ring applicator, to displace the posterior vaginal wall. The belt immobilization system consists of a specially designed bracket that can hold and fix itself to the applicator, a diaper-like Velcro fastener package used for connecting the patient's pelvis to the bracket, and a buckle that holds the fasteners to stabilize the whole system. The treatment data for 21 patients with cervical cancer using both balloon catheter and belt immobilization system were retrospectively analyzed. Computed tomography and magnetic resonance images, acquired about 30 minutes apart, were registered to evaluate the effectiveness of the immobilization system.
RESULTS
In comparison with a virtual rectal blade, the balloon decreased the rectal point dose by 34% ± 4.2% (from 276 ± 57 to 182 ± 38 cGy), corresponding to an extra sparing distance of 7.9 ± 1.1 mm. The maximum sparing distance variation per patient is 1.4 ± 0.6 mm, indicating the high interfractional reproducibility for rectum sparing. With the immobilization system, the mean translational and rotational displacements of the applicator set are <3 mm and <1.5°, respectively, in all directions.
CONCLUSIONS
The rectal balloon provides significant dose reduction to the rectum and it may potentially minimize patient discomfort. The immobilization system permits almost no movement of the applicator during treatment. This work has the potential to be promoted as a standardized solution for high-dose rate treatment of cervical cancer.
Topics: Brachytherapy; Catheters; Cervix Uteri; Contrast Media; Female; Humans; Magnetic Resonance Imaging; Radiotherapy Dosage; Rectum; Tomography, X-Ray Computed; Uterine Cervical Neoplasms
PubMed: 26868850
DOI: 10.1177/1533034616631122 -
Circulation. Cardiovascular... Oct 2018
Topics: Angioplasty, Balloon, Coronary; Brachytherapy; Drug-Eluting Stents
PubMed: 30354643
DOI: 10.1161/CIRCINTERVENTIONS.118.007365 -
Current Oncology (Toronto, Ont.) Oct 2021(1) Background: We aimed to analyze currently available studies with intraoperative radiotherapy (IORT) as a choice of treatment where the Xoft Axxent electronic... (Review)
Review
(1) Background: We aimed to analyze currently available studies with intraoperative radiotherapy (IORT) as a choice of treatment where the Xoft Axxent electronic brachytherapy (eBx) system was used as a single-dose irradiation and an exclusive radiotherapy approach at the time of surgery in patients with early breast cancer (EBC). We also compared the results of the systematic review to the Bulgarian experience. (2) Methods and Materials: We performed a systematic review of the studies published before February 2021, which investigate the application of a single-fraction 20 Gy radiation treatment, delivered at the time of lumpectomy in EBC patients with the Xoft Axxent eBx System. A systematic search in PubMed, Scopus, and ScienceDirect was performed. The results are reported following the PRISMA guidelines. The criteria on patients' selection for IORT (the additional need for EBRT), cosmetic outcomes, and recurrence rate from the eligible studies are compared to the treatment results in Bulgarian patients. (3) Results: We searched through 1032 results to find 17 eligible studies. There are no published outcomes from randomized trials. When reported, the cosmetic outcomes in most of the studies are defined as excellent. The observed recurrence rate is low (1-5.8%). Still, the number of patients additionally referred to postoperative external breast radiotherapy (EBRT) is up to 31%. Amongst the 20 patients treated in Bulgaria, the cosmetic outcomes are also evaluated as excellent, five of which (25%) are referred for EBRT. Within median follow-up of 39 months, there was one local and one distal recurrence. (4) Conclusions: Current evidence demonstrates the Xoft Axxent eBx system as a safe and feasible technique for IORT delivery in EBC patients. There are no randomized controlled trials conducted at this time point to prove its long-term effectiveness. Better patient selection and a reimbursement strategy have to be proposed to extend the application of this technique in Bulgaria.
Topics: Brachytherapy; Breast Neoplasms; Bulgaria; Electronics; Female; Humans; Neoplasm Recurrence, Local
PubMed: 34677253
DOI: 10.3390/curroncol28050335 -
Radiation Oncology (London, England) Oct 2010Breast conservation therapy (BCT) is the procedure of choice for the management of the early stage breast cancer. However, its utilization has not been maximized because... (Review)
Review
Breast conservation therapy (BCT) is the procedure of choice for the management of the early stage breast cancer. However, its utilization has not been maximized because of logistics issues associated with the protracted treatment involved with the radiation treatment. Accelerated Partial Breast Irradiation (APBI) is an approach that treats only the lumpectomy bed plus a 1-2 cm margin, rather than the whole breast. Hence because of the small volume of irradiation a higher dose can be delivered in a shorter period of time. There has been growing interest for APBI and various approaches have been developed under phase I-III clinical studies; these include multicatheter interstitial brachytherapy, balloon catheter brachytherapy, conformal external beam radiation therapy and intra-operative radiation therapy (IORT). Balloon-based brachytherapy approaches include Mammosite, Axxent electronic brachytherapy and Contura, Hybrid brachytherapy devices include SAVI and ClearPath. This paper reviews the different techniques, identifying the weaknesses and strength of each approach and proposes a direction for future research and development. It is evident that APBI will play a role in the management of a selected group of early breast cancer. However, the relative role of the different techniques is yet to be clearly identified.
Topics: Brachytherapy; Breast Neoplasms; Female; Humans; Radiotherapy
PubMed: 20920346
DOI: 10.1186/1748-717X-5-90 -
BioMed Research International 2016Radiotherapy (RT) for prostate cancer (PC) has steadily evolved over the last decades, with improving biochemical disease-free survival. Recently population based... (Review)
Review
Radiotherapy (RT) for prostate cancer (PC) has steadily evolved over the last decades, with improving biochemical disease-free survival. Recently population based research also revealed an association between overall survival and doses ≥ 75.6 Gray (Gy) in men with intermediate- and high-risk PC. Examples of improved RT techniques are image-guided RT, intensity-modulated RT, volumetric modulated arc therapy, and stereotactic ablative body RT, which could facilitate further dose escalation. Brachytherapy is an internal form of RT that also developed substantially. New devices such as rectum spacers and balloons have been developed to spare rectal structures. Newer techniques like protons and carbon ions have the intrinsic characteristics maximising the dose on the tumour while minimising the effect on the surrounding healthy tissue, but clinical data are needed for confirmation in randomised phase III trials. Furthermore, it provides an overview of an important discussion issue in PC treatment between urologists and radiation oncologists: the comparison between radical prostatectomy and RT. Current literature reveals that all possible treatment modalities have the same cure rate, but a different toxicity pattern. We recommend proposing the possible different treatment modalities with their own advantages and side-effects to the individual patient. Clinicians and patients should make treatment decisions together () while using patient decision aids.
Topics: Clinical Decision-Making; Health Knowledge, Attitudes, Practice; Humans; Male; Prostatic Neoplasms; Radiation Injuries; Radiation Protection; Radiotherapy; Radiotherapy Planning, Computer-Assisted; Treatment Outcome
PubMed: 28116302
DOI: 10.1155/2016/6829875 -
International Journal of Surgery... 2012Restenosis is a fundamental weakness of percutaneous femoropopliteal angioplasty (PTA). The potential of endovascular brachytherapy (EVBT) to reduce restenosis has been... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Restenosis is a fundamental weakness of percutaneous femoropopliteal angioplasty (PTA). The potential of endovascular brachytherapy (EVBT) to reduce restenosis has been evaluated in randomized clinical trials, but no pooled analysis has been undertaken.
METHODS
A systematic review was undertaken to identify randomized controlled trials in which PTA alone was compared to PTA plus EVBT. The Pubmed and Medline databases, American Heart Association OASIS database and conference proceedings from the Peripheral Vascular Surgery Society and Vascular Society of Great Britain and Ireland were searched. Eligible studies were randomised controlled trials comparing PTA to PTA plus EVBT in human subjects with at least one clinical outcome reported (restenosis, complications, patency). Study quality was assessed by the Jadad score. Random-effects modeling was used to generate pooled effect size estimates.
RESULTS
Six trials (687 patients) were identified. EVBT reduced 12-month restenosis rates (pooled odds ratio 0.50; 95% CI 0.301-0.836; p=0.008). The benefit disappeared by 24 months. The short-term risk of new lesions elsewhere in the treated artery was significantly increased by EVBT (pooled odds ratio 8.65; 95% CI 2.176-34.391; p=0.002).
CONCLUSIONS
While limited by the small sample sizes in the included trials, this analysis suggests that the early benefit of EVBT is counter-balanced by the increased risk of new lesions and the lack of medium- to long-term reductions in restenosis risk. Based upon the best available evidence, EVBT cannot be recommended for routine clinical use.
Topics: Angioplasty, Balloon; Arterial Occlusive Diseases; Brachytherapy; Endovascular Procedures; Femoral Artery; Humans; Popliteal Artery; Recurrence; Treatment Outcome
PubMed: 22349154
DOI: 10.1016/j.ijsu.2012.02.008 -
Cancers Dec 2023Previous work has reported the design of a novel thermobrachytherapy (TBT) balloon implant to deliver magnetic nanoparticle (MNP) hyperthermia and high-dose-rate (HDR)...
Previous work has reported the design of a novel thermobrachytherapy (TBT) balloon implant to deliver magnetic nanoparticle (MNP) hyperthermia and high-dose-rate (HDR) brachytherapy after brain tumor resection, thereby their synergistic effect. This paper presents an evaluation of the robustness of the balloon device, compatibility of its heat and radiation delivery components, as well as thermal and radiation dosimetry of the TBT balloon. TBT balloon devices with 1 and 3 cm diameter were evaluated when placed in an external magnetic field with a maximal strength of 8.1 kA/m at 133 kHz. The MNP solution (nanofluid) in the balloon absorbs energy, thereby generating heat, while an HDR source travels to the center of the balloon via a catheter to deliver the radiation dose. A 3D-printed human skull model was filled with brain-tissue-equivalent gel for in-phantom heating and radiation measurements around four 3 cm balloons. For the experiments, a 1 cm diameter balloon was surgically implanted in the brains of three living pigs (40-50 kg). The durability and robustness of TBT balloon implants, as well as the compatibility of their heat and radiation delivery components, were demonstrated in laboratory studies. The presence of the nanofluid, magnetic field, and heating up to 77 °C did not affect the radiation dose significantly. Thermal mapping and 2D infrared images demonstrated spherically symmetric heating in phantom as well as in brain tissue. pig experiments showed the ability to heat well-perfused brain tissue to hyperthermic levels (≥40 °C) at a 5 mm distance from the 60 °C balloon surface.
PubMed: 38067387
DOI: 10.3390/cancers15235683 -
The Cochrane Database of Systematic... Jan 2014Interventional treatment of arteries that are narrowed and obstructed by atherosclerosis involves either bypassing the blockage using a graft; widening the artery from... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Interventional treatment of arteries that are narrowed and obstructed by atherosclerosis involves either bypassing the blockage using a graft; widening the artery from the inside with a balloon, a procedure known as percutaneous transluminal angioplasty (PTA); or providing a strut to hold the vessel open, known as a stent. All of these treatments are, however, limited by the high numbers that fail within a year. Intravascular brachytherapy is the application of radiation directly to the site of vessel narrowing. It is known to inhibit the processes that lead to restenosis (narrowing) of vessels and grafts after treatment. This is an update of a review first published in 2002.
OBJECTIVES
To assess the efficacy of, and complications associated with, intravascular brachytherapy (IVBT) for maintaining patency after angioplasty or stent insertion in native vessels or bypass grafts of the iliac or infrainguinal arteries.
SEARCH METHODS
For this update the Cochrane Peripheral Vascular Diseases Group Trials Search Co-ordinator searched their Specialised Register (last searched August 2013) and CENTRAL (2013, Issue 7).
SELECTION CRITERIA
Randomised controlled trials of the use of brachytherapy as an adjunct to the endovascular treatment of people with peripheral arterial disease (PAD) or stenosed bypass grafts of the iliac or infrainguinal arteries versus the procedure without brachytherapy.
DATA COLLECTION AND ANALYSIS
Two review authors independently assessed trial quality and two other review authors independently extracted the data. Adverse event information was collected from the trials.
MAIN RESULTS
Eight trials with a combined total of 1090 participants were included in this review. All included studies used the femoropopliteal artery. We did not identify any studies that used the iliac arteries. All studies compared PTA with or without stenting plus IVBT versus PTA with or without stenting alone. No trials were found comparing IVBT to technologies such as drug eluting stents or balloons, or cryoplasty. Follow-up ranged from six months to five years. The quality of the included trials was moderate with our concerns relating to the difficulty of blinding due to the nature of the procedures and the small sample sizes for some studies. Primary outcomes (patency or restenosis and need for re-intervention) were reported in the majority of the trials, but reporting at various time points and the use of multiple definitions of the outcomes by the included studies meant that not all data were available for pooling. The secondary outcomes were not reported in many of the included studies.For brachytherapy, cumulative patency was higher at 24 months (odds ratio (OR) 2.36, 95% confidence interval (CI) 1.36 to 4.10, n = 222, P = 0.002). A statistically significant difference was found for restenosis at six months (OR 0.27, 95% CI 0.11 to 0.66, n = 562, P = 0.004), 12 months (OR 0.44, 95% CI 0.28 to 0.68, n = 375, P = 0.0002) and 24 months (OR 0.41, 95% CI 0.21 to 0.78, n = 164, P = 0.007) in favour of IVBT. No difference was found after five years as measured in one study. The need for re-interventions was reported in six studies. Target lesion revascularisation was significantly reduced in trial participants treated with IVBT compared with angioplasty alone (OR 0.51, 95% CI 0.27 to 0.97, P = 0.04) at six months after the interventions. No statistically significant difference was found between the procedures on the need for re-intervention at 12 and 24 months after the procedures.A statistically significant lower number of occlusions was found in the control group at more than three months (OR 11.46, 95% CI 1.44 to 90.96, n = 363, P = 0.02) but no differences were found at less than one month nor at 12 months after the procedures making the clinical significance uncertain. Ankle brachial index was statistically significantly better for IVBT at the 12 month follow-up (mean difference 0.08, 95% CI 0.02 to 0.14, n = 100, P = 0.02) but no statistically significant differences were found at 24 hours and at six months.Quality of life, complications, limb loss, cardiovascular deaths, death from all causes, pain free walking distance and maximum walking distance on a treadmill were similar for the two arms of the trials with no statistically significant difference found between the treatment groups.
AUTHORS' CONCLUSIONS
The evidence for using peripheral artery brachytherapy as an adjunct to percutaneous transluminal angioplasty to maintain patency and for the prevention of restenosis in people with peripheral vascular disease is limited, mainly due to the inconsistency of assessment and reporting of clinically relevant outcomes. More data are needed on clinically relevant outcomes such as health related quality of life (HRQOL) or limb salvage and longer-term outcomes, together with comparisons with other techniques such as drug eluting balloons and stents. Adequately powered randomised controlled trials, health economics and cost-effectiveness data are required before the procedure could be recommended for widespread use.
Topics: Angioplasty; Brachytherapy; Endovascular Procedures; Femoral Artery; Humans; Peripheral Vascular Diseases; Popliteal Artery; Quality of Life; Radiotherapy, Adjuvant; Randomized Controlled Trials as Topic; Stents; Vascular Patency
PubMed: 24399686
DOI: 10.1002/14651858.CD003504.pub2 -
Journal of Vascular Surgery Jan 2017Treatment of superficial femoral artery (SFA) lesions remains challenging. We conducted a network meta-analysis of randomized controlled trials aiming to explore the... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Treatment of superficial femoral artery (SFA) lesions remains challenging. We conducted a network meta-analysis of randomized controlled trials aiming to explore the efficacy of treatment modalities for SFA "de novo" lesions.
METHODS
Eleven treatments for SFA occlusive disease were recognized. We used primary patency and binary restenosis at 12-month follow-up as proxies of efficacy for the treatment of SFA lesions.
RESULTS
A total of 33 studies (66 study arms; 4659 patients) were deemed eligible. In terms of primary patency, odds ratios (ORs) with 95% confidence intervals (CIs) were statistically significantly higher in drug-eluting stent (DES; OR, 10.05; 95% CI, 3.22-31.39), femoropopliteal bypass surgery (BPS; OR, 7.15; 95% CI, 2.27-22.51), covered stent (CS; OR, 3.56; 95% CI, 1.33-9.53), and nitinol stent (NS; OR, 2.83; 95% CI, 1.42-5.51) compared with balloon angioplasty (BA). The rank order from higher to lower primary patency in the multidimensional scaling was DES, BPS, NS, CS, drug-coated balloon, percutaneous transluminal angioplasty with brachytherapy, stainless steel stent, cryoplasty (CR), and BA. Combination therapy of NS with CR and drug-coated balloon were the two most effective treatments, followed by NS, CS, percutaneous transluminal angioplasty with brachytherapy, cutting balloon, stainless steel stent, BA, and CR in terms of multidimensional scaling values for binary restenosis.
CONCLUSIONS
DES has shown encouraging results in terms of primary patency for SFA lesions, whereas BPS still maintains its role as a principal intervention. On the contrary, BA and CR appear to be less effective treatment options.
Topics: Alloys; Angioplasty, Balloon; Arterial Occlusive Diseases; Brachytherapy; Cardiovascular Agents; Coated Materials, Biocompatible; Constriction, Pathologic; Cryotherapy; Drug-Eluting Stents; Endovascular Procedures; Femoral Artery; Humans; Network Meta-Analysis; Odds Ratio; Prosthesis Design; Randomized Controlled Trials as Topic; Recurrence; Risk Factors; Stents; Time Factors; Treatment Outcome; Vascular Access Devices; Vascular Patency; Vascular Surgical Procedures
PubMed: 27865639
DOI: 10.1016/j.jvs.2016.08.095