Cost-Effectiveness of the Biozorb Device for Radiation Planning in Oncoplastic Surgery

Rashad, Ramy; Huber, Kathryn E.; Chatterjee, Abhishek

doi:10.5539/cco.v7n2p23

Cited by 6 publications

(3 citation statements)

References 51 publications

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“…A smaller marker, or avoidance of utilization of the marker is recommended if a paucity of overlying tissue exists (36). Biozorb  has not demonstrated value given its relative high cost and lack of clinical advantage scientifically over the use of surgical clips (38).…”

Section: Biozorb mentioning

confidence: 99%

A novel, adaptable, radiographically opaque, multi-plane continuous filament marker for optimizing tissue identification, radiation planning, and radiographic follow-up

Mitchell¹,

Lee²,

Dupree³

et al. 2019

Gland Surg

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Background: In breast cancer treatment, marking the tumor bed is an important aspect of the surgical component of therapy. Clear delineation of the tumor bed allows radiation oncologists a defined target for planning and delivering postoperative radiation therapy (XRT). Tumor bed marking also allows radiographic follow-up of the tumor bed on subsequent breast imaging. The aim of this assessment is to evaluate the ease and feasibility of utilizing a tumor bed filament marker (VeraForm  , Videra Surgical inc., USA) as a marker in post-operative benign surgical sites and malignant breast surgical tumor beds in breast cancer surgery. Methods:The filament marker is a novel radiopaque surgical filament that in lieu of clips and other markers is implanted in the surgical tumor bed during breast surgery. Following development of the filament marker, the researchers used breast phantoms and radiographic images to develop a series of geometric patterns of placement options that optimize comprehensive multi-plane radiographic interpretation of the exact tumor bed or surgical margin. Three breast surgeons at 3 separate institutions then used this filament as a continuous multi-plane marker in 20 patients during breast conservation surgery. In these patients, the filament marker was thus used to mark the tumor bed (breast cancer surgery) or surgical site (benign breast disease) instead of the more traditional devices such as clips or other metallic open framework devices.We then assessed 2 important factors related to this device; (I) the ease, feasibility, and accuracy of in vivo placement with oncoplastic and non-oncoplastic breast conservation surgery techniques; (II) the radiographic footprint this device left on standard imaging protocols of post-operative mammogram (MMG), computed tomography (CT) scan, breast magnetic resonance imaging (MRI) examinations, and ultrasounds (USs) for both routine follow-up imaging and for standard radiation planning.Results: There were no adverse events reported with the use of this device. The cases were then reviewed by a multidisciplinary team that included the original surgeon, a breast radiologist, and radiation oncologist.Their unanimous evaluation was that the filament marker clearly delineated all sides and planes of the tumor bed (cancer surgery) or surgical site (benign disease). Regardless of surgical technique utilized, this information provided precise 3D guidance for radiation planning and delivery as well as radiographic followup. The surgeons involved reported that delineating the bed with the filament marker was a quick and easy procedure and did not interfere with performing the planned surgical technique. Radiologists, surgeons, 610 Mitchell et al. Continuous radiopaque filament marker

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Section: Biozorb mentioning

confidence: 99%

A novel, adaptable, radiographically opaque, multi-plane continuous filament marker for optimizing tissue identification, radiation planning, and radiographic follow-up

Mitchell¹,

Lee²,

Dupree³

et al. 2019

Gland Surg

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“…However, breast surgeons have used this bioresorbable device with hopes that it would also assist in filling the tissue void and improving cosmetic results. Published clinical studies indicate that both surgeons and patients have been uniformly dissatisfied with BioZorb since this implant is relatively expensive, does not significantly improve outcomes, and gives rise to a hard, palpable lump that lasts for up to 2.8 years and causes patient discomfort 16 , 17 .…”

Section: Introductionmentioning

confidence: 99%

Regenerative tissue filler for breast conserving surgery and other soft tissue restoration and reconstruction needs

Puls¹,

Fisher

Cox

et al. 2021

Sci Rep

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Complete removal of cancerous tissue and preservation of breast cosmesis with a single breast conserving surgery (BCS) is essential for surgeons. New and better options would allow them to more consistently achieve this goal and expand the number of women that receive this preferred therapy, while minimizing the need for re-excision and revision procedures or more aggressive surgical approaches (i.e., mastectomy). We have developed and evaluated a regenerative tissue filler that is applied as a liquid to defects during BCS prior to transitioning to a fibrillar collagen scaffold with soft tissue consistency. Using a porcine simulated BCS model, the collagen filler was shown to induce a regenerative healing response, characterized by rapid cellularization, vascularization, and progressive breast tissue neogenesis, including adipose tissue and mammary glands and ducts. Unlike conventional biomaterials, no foreign body response or inflammatory-mediated “active” biodegradation was observed. The collagen filler also did not compromise simulated surgical re-excision, radiography, or ultrasonography procedures, features that are important for clinical translation. When post-BCS radiation was applied, the collagen filler and its associated tissue response were largely similar to non-irradiated conditions; however, as expected, healing was modestly slower. This in situ scaffold-forming collagen is easy to apply, conforms to patient-specific defects, and regenerates complex soft tissues in the absence of inflammation. It has significant translational potential as the first regenerative tissue filler for BCS as well as other soft tissue restoration and reconstruction needs.

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“…Cost analysis is needed as previous studies have shown cost benefit to clips over 3DBM in identifying the tumor bed for radiation. 5 Additionally, operative time comparisons and long-term effects must be considered. In conclusion, TR with use of 3DBM may allow surgeons more basic oncoplastic options to improve patient satisfaction.…”

mentioning

confidence: 99%

Improved Overall Well-Being After Breast Conserving Therapy Using Three-Dimensional Bioabsorbable Markers and Tissue Rearrangement, a Single Institution’s Preliminary Experience

Jordan

Rebielak

Johnson

et al. 2021

The American Surgeon™

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Tissue rearrangement (TR) is a basic oncoplastic technique to reshape the breast after breast conserving therapy (BCT). Tissue rearrangement can be combined with three-dimensional bioabsorbable markers (3DBM) as an easily adaptable technique to provide volume replacement and focused radiation. Since 3DBM can take time for absorption and symptoms related to its use have not been fully assessed, we evaluate patient’s overall satisfaction and well-being after TR with 3DBM is performed. We surveyed patients receiving BCT with adjuvant radiotherapy using BREAST-QTM BCT satisfaction and physical well-being surveys comparing patients receiving BCT alone to BCT with TR and/or 3DBM. Of 68 patients, 56 underwent BCT alone, 10 had BCT with TR + 3DBM, and 2 had BCT with TR. No significant difference was seen in physical well-being ( P = .39), while overall satisfaction was significantly improved following TR + 3DBM ( P = .0088). In summary, TR with use of 3DBM provides basic oncoplastic options to improve patient satisfaction without significantly changing symptoms.

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Cost-Effectiveness of the Biozorb Device for Radiation Planning in Oncoplastic Surgery

Cited by 6 publications

References 51 publications

A novel, adaptable, radiographically opaque, multi-plane continuous filament marker for optimizing tissue identification, radiation planning, and radiographic follow-up

A novel, adaptable, radiographically opaque, multi-plane continuous filament marker for optimizing tissue identification, radiation planning, and radiographic follow-up

Regenerative tissue filler for breast conserving surgery and other soft tissue restoration and reconstruction needs

Improved Overall Well-Being After Breast Conserving Therapy Using Three-Dimensional Bioabsorbable Markers and Tissue Rearrangement, a Single Institution’s Preliminary Experience

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