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Replace Gauze Packing
for superior OAR displacement
Designed
for patient comfort

“Physicians noted a marked increase in patient comfort of balloon-packed patients as well as a reduction in time required to pack the patient when compared to conventional methods.”

Significant Reduction
in bladder and rectal dose
Reduction In Dose
Increasing Clinical Adoption
through proven results
Reduction In Dose Reduction In Dose
Patient Comfornt

Evaluation of a Balloon-Based Vaginal Packing System and Patient-Controlled Analgesia for Patients with Cervical Cancer Undergoing High-Dose-Rate Intracavitary Brachytherapy
Meng Xu-Welliver MD, PhD a, Lilie L. Lin MD, Department of Radiation Oncology, The Ohio State University College of Medicine, Arthur G. James Comprehensive Cancer Center, Columbus, Ohio, Pract Radiat Oncol; 3(4):263-8, Oct-Dec 2013

Purpose: To evaluate the following: (1) the dosimetric impact on the bladder and rectum due to a methodologic shift from general anesthesia (GA) to patient-controlled analgesia (PCA), and from vaginal gauze packing (VGP) to vaginal balloon-based packing (VBP) for high-dose-rate (HDR) intracavitary brachytherapy; and (2) the tolerability of PCA versus GA.

Materials/Methods: Seventeen consecutively treated patients with cervical carcinoma who underwent tandem and ovoid (T&O) HDR brachytherapy from January 2009 to August 2010 were selected and reviewed. There were a total of 73 applications. Patients were packed either conventionally with VGP (n = 49) or with VBP (n = 24). Because different sedation methods can influence rectal and bladder dosimetric parameters all applications were grouped by packing method (VBP or VGP) as well as sedation method (GA or PCA). The International Commission on Radiation Units and Measurements (ICRU) and D2cc rectal and bladder doses were obtained from the treatment records and dose-volume histograms, and respective percentage of prescription dose noted and compared. For patients receiving PCA, pain score on a scale of 0-10 was noted.

Results: All patients who used PCA were able to tolerate and complete the procedure with a median pain score of 0 (range, 0-2). Implants packed with the VBP method under PCA (n = 21) versus VGP under GA (n = 40) had significantly lower doses to the bladder D2cc (85.7% vs 104.8% of prescription dose), and rectum ICRU dose point (55.4% vs 65.2% of prescription dose), P = .0371 and .039, respectively. The ICRU bladder point and rectum D2cc between the 2 groups were not significantly different.

Conclusions: Our results demonstrate that PCA is a feasible method for pain control for T&O brachytherapy. VBP and PCA are compatible with T&O brachytherapy and resulted in comparable if not better bladder and rectal dosimetry.

Evaluation Of A Balloon-Based Vaginal Packing System For Brachytherapy Of Cervical Carcinoma
M. Price, J. Fontenot, M. Sanders , S. Johnson , C. Wood, Mary Bird Perkins Cancer Center, Baton Rouge, LA, 2 Department of Physics and Astronomy, Louisiana State University, Baton Rouge, LA, Int. J. Radiat Oncol Biol Phys, Volume 78 , Issue 3 , S405 - S406, 2010

Purpose: To reduce dose to organs at risk (OAR) and take advantage of the R2 falloff of brachytherapy source radiation, clinicians will pack the upper vagina to displace healthy tissues surrounding the cervix away from high-dose gradients. Traditional packing consists of cotton material or gauze. Patient discomfort often limits the amount and quality of vaginal packing which may lead to high doses to the bladder and rectum. This study evaluates the use of intracavitary balloons to replace conventional methods for intracavitary brachytherapy (ICBT) packing where a tandem and ovoid applicator (TOA) is utilized. Dosimetric advantages, with respect to reductions in dose to OAR as well as clinical efficacy and improvements in patient comfort are considered.

Materials/Methods: Patient selection was limited to women undergoing ICBT for the treatment of cervical cancer delivered via a CT/MR compatible TOA (Nucletron, Veenendaal). For each delivered fraction, patients were packed either conventionally or utilizing a newly developed, balloon-based, gynecological packing system (n = 11 and 14, respectively). The system consists of a pair of balloons, designed to be placed superior and inferior to inserted ovoids while deflated (Radiadyne, Houston, TX). Once positioned, the balloons are filled with water (20 to 40cc) and expand to displace the proximal bladder and rectal walls. Treatments were planned under CT following American Brachytherapy Society guidelines, and 600 cGy was prescribed to the ICRUdefined Point A. ICRU rectal and bladder points, as well as the minimum dose to the most irradiated contiguous volume of 2cc (D2cc), were tallied and compared for each packing method. Clinical implementation of the new device was contingent upon physician approval based upon patient comfort and ease of use.

Results: Average dose to the ICRU bladder point was 39% ± 4.9% less for patients packed utilizing the balloon system. Differences in average dose to the ICRU rectal point for each patient group was statistically insignificant (0.2% ± 4.9%). On average, D2cc of bladder and rectal tissue was reduced by 32.2% ± 4.5% and 11.0% ± 3.3%, respectively, for patients packed using the balloon system. Physicians noted a marked increase in patient comfort of balloon-packed patients as well as a reduction in time required to pack the patient when compared to conventional methods.

Conclusions: Considering D2cc, the balloon-based packing method resulted in a significant reduction in dose to the bladder and rectum for ICBT patients treated with a TOA. A similar reduction was also observed for average ICRU bladder point dose. Dose reductions to the ICRU rectal point proved insignificant. In addition, improved patient comfort has lead to permanent clinical implementation of this packing system.

Improved Dosimetry

Initial Experience with Alatus Vaginal Balloon Packing (VBP) Compared to Standard Vaginal Gauze Packing (SGP) for Tandem and Ovoid Brachytherapy Treatment of Carcinoma of the Cervix
I.M. Ahmed, A.S. Saini, PhD., D. Hunt, W. Skinner, S.E. Finkelstein, M.D., M.C. Biagiol M.D., Int. J. Radiat Oncol Biol Phys, Vol 78, Issue 3, Supplement PS417, 2010

Purpose: We report initial experience with vaginal balloon packing (VBP) compared with standard gauze packing (SGP).

Materials/Methods: Four patients undergoing fractionated HDR brachytherapy underwent alternating vaginal packing with either standard gauze packing (SGP) or with Alatus VBP. Brachytherapy was performed in 5 fractions, 600 cGy/ fraction, using a Royal Marsden applicator. Patients undergoing VBP, two balloons were used, one positioned anterior and second posterior to the ovoids and filled with normal saline. Brachytherapy planning was performed using an MRI for HRCTV and OAR delineation fused in Pinacle () to a CT then imported into PLATO (Nucletron, Netherlands) for applicator reconstruction and dosimetric determination based on GEC-ESTRO working group recommendations. In addition, a simultaneous plan was generated for each fraction optimized to point A. GTV and HRCTV D90 and V100 along with OAR D 0.1cc, 0.2cc, 0.5cc, 1cc, 2cc, and 5cc doses were calculated for each fraction. Data represents the mean difference SBP minus VGP. Positive numbers favor the ALATUS and negative numbers favor SBP.

Results: When planned according to GEC-ESTRO recommendations mean intra-patient differences between Alatus VBP and SGP was HRCTV D90: -24.8 cGy and V100: -1.6 cc. Rectal D0.1cc :65.2 cGy, 0.2cc: 62.4 cGy, 0.5cc: 61.6 cGy, 1cc :58.8 cGy, 2cc: 58.4 cGy, 5cc :38.9 cGy. Bladder D0.1cc 93.2 cGy, 0.2cc 93.1 cGy, 0.5cc 56.7 cGy, 1cc 35.9 cGy, 2cc 32.9 cGy, 5cc 38.3 cGy. When planned with prescription dose to ICRU 38 defined pointA mean intra-patient differences between Alatus VBP and SGP was HRCTV D90: 8.1 cGy and V100: 28.6 cc. Rectal D0.1cc :69.2 cGy, 0.2cc :65.7 cGy, 0.5cc: 57.9 cGy, 1cc 52.3 :cGy, 2cc:44.7 cGy, 5cc :26.8 cGy. Bladder D0.1cc :251.2 cGy, 0.2cc :224.6 cGy, 0.5cc :187.3 cGy, 1cc :148.8, 2cc 118.6, 5cc :93.1 cGy.

Conclusions: Both rectal and vaginal dosimetry favored ALATUS balloon packing over Standard Gauze packing whether planned according to GEC-ESTRO or ICRU point A.HRCTV and D90 marginally favored SBP when planned to GEC-ESTRO guidelines but not when planned to Point A. This difference is likely due to the adaptive nature of treating a sequentially reduced volume rather than prescribing to a point.

The Dosimetric Impact of Vaginal Balloon Packing on Brachytherapy for Gynecological Cancer
W. M. Rockey, S. K. Bhatia, G. M. Jacobson, Y. Kim, University of Iowa Hospitals & Clinics, Iowa City, IA, Int. J. Radiat Oncol Biol Phys, Vol 81, Issue 2, Supplement PS457, 2011

Purpose: A balloon-based vaginal packing system used in conjunction with a tandem-and-ovoids applicator (T and O) for delivery of HDR brachytherapy offers several benefits over traditional gauze packing, including decreased risk of vaginal laceration during packing, greater reproducibility among fractions, and the ability to easily reposition the applicators after the packing is in place. In this study, we investigate if the dose per fraction delivered to the rectum, bladder, or sigmoid is significantly different with balloon packing versus traditional gauze packing.

Materials/Methods: We retrospectively reviewed 29 HDR brachytherapy plans of 9 patients that were performed with gauze packing and 18 plans of 6 patients performed with the Alatus balloon packing system (Radiadyne, Houston, TX). Also, an intra- patient comparison was performed on 4 patients who each received 1 - 2 fractions with gauze packing and 1 - 2 fractions with balloon packing. The normal HDR prescription was 5.5 Gy x 5 fractions or less often 7 Gy x 3 - 4 fractions. A titanium Fletcher-Suit-Delclos style Tand O applicator (Varian, Palo Alto, CA) was used. At each fraction, either 3.0T MRI or CT datasets were obtained. The bladder, rectum, and sigmoid were contoured according to the GEC-ESTRO-EMBRACE protocol, and the D2cc was calculated for these structures, as were traditional ICRU-defined point doses.

Results: In the 4-patient intra-patient comparison, the average rectal D2cc per fraction was significantly lower for balloon packing (gauze: 4.0 ± 1.0 Gy; balloon: 2.7 ± 0.9 Gy; p = 0.01). The doses to the bladder (gauze: 6.6 ± 2.9 Gy; balloon: 5.3 ± 2.0 Gy) and sigmoid (gauze: 3.8 ± 0.6 Gy; balloon: 2.9 ± 1.1 Gy) were not significantly different. The left and right point A doses were not significantly different between the gauze and balloon fractions (gauze 6.0 ± 0.7 Gy [left] and 6.2 ± 0.9 Gy [right]; balloon: 6.1 ± 0.8 Gy [left] and 6.2 ± 0.8 Gy [right]). A comparison of all 29 gauze fractions and 18 balloon fractions showed that none of the doses were significantly different between the two groups: left and right point A (gauze: 6.0 ± 0.8 Gy; balloon: 6.1 ± 0.8 Gy); rectal D2cc (gauze: 3.8 ± 1.1 Gy; balloon: 3.1 ± 1.1 Gy); bladder D2cc (gauze: 5.1 ± 1.4 Gy; balloon: 5.3 ± 3.3 Gy), or the sigmoid D2cc (gauze: 3.7 ± 1.0 Gy; balloon: 3.5 ± 1.5 Gy).

Conclusions: A comparison of 47 HDR plans showed that vaginal balloon packing for HDR brachytherapy is at least as effective as gauze packing for decreasing doses to the bladder, rectum, and sigmoid. To control for anatomical differences among patients, an intra-patient comparison of patients who received both gauze and balloon packing showed that balloon packing provides potentially superior rectal sparing over gauze packing. Further intra-patient comparisons may show improved sparing in other organs as well.

Dose Reduction Study In Vaginal Balloon Packing Filled With Contrast For HDR Brachytherapy Treatment
A.S Saini, PhD., G.G. Zhang, PhD., S.E. Finketlstein, M.D., M.C. Biagioli, M.D., Radiation Oncology, Moffitt Cancer Center, Tampa, FL, Int. J. Radiat Oncol Biol Phys, Vol 80, Issue 4, p 1263 - 1267, July 2011

Purpose: Vaginal balloon packing is a means to displace organs at risk during high dose rate brachytherapy of the uterine cervix. We tested the hypothesis that contrast-filled vaginal balloon packing reduces radiation dose to organs at risk, such as the bladder and rectum, in comparison to water- or air-filled balloons.

Methods/Materials: In a phantom study, semispherical vaginal packing balloons were filled with air, saline solution, and contrast agents. A high dose rate iridium-192 source was placed on the anterior surface of the balloon, and the diode detector was placed on the posterior surface. Dose ratios were taken with each material in the balloon. Monte Carlo (MC) simulations, by use of the MC computer program DOSXYZnrc, were performed to study dose reduction vs. balloon size and contrast material, including commercially available iodine- and gadoliniumbased contrast agents.

Results: Measured dose ratios on the phantom with the balloon radius of 3.4 cm were 0.922 ± 0.002 for contrast/ saline solution and 0.808 ± 0.001 for contrast/air. The corresponding ratios by MC simulations were 0.895 ± 0.010 and 0.781 ± 0.010. The iodine concentration in the contrast was 23.3% by weight. The dose reduction of contrastfilled balloon ranges from 6% to 15% compared with water-filled balloon and 11% to 26% compared with airfilled balloon, with a balloon size range between 1.4 and 3.8 cm, and iodine concentration in contrast of 24.9%. The dose reduction was proportional to the contrast agent concentration. The gadolinium-based contrast agents showed less dose reduction because of much lower concentrations in their solutions.

Conclusions: The dose to the posterior wall of the bladder and the anterior wall of the rectum can be reduced if the vaginal balloon is filled with contrast agent in comparison to vaginal balloons filled with saline solution or air.

Reproducibility

Reproducibility of Immobilization Balloons Used Sequentially for Cervical Cancer HDR Brachytherapy
U. Goyal, J. Pan, and S.T. Dougherty, University of Arizona, Tucson, AZ, Int. J. Radiat Oncol Biol Phys , Volume 93 , Issue 3 , E283, 2015

Purpose: The use of inflatable balloons, instead of traditional packing, for immobilization during tandem and ovoid (T&O) brachytherapy improves surgical time, reproducibility, and comfort for radiation planning and treatment on sequential days. Like packing, the balloons reduce bladder and rectal doses. Our aim was to show that balloons for HDR brachytherapy are safe and reproducible when left overnight for treatment on sequential days.

Materials/Methods: A retrospective study was done where the T&O treatment program required the patient to have a fractionated course and remain overnight in hospital with the apparatus in place. Patients had a diagnosis of cervical cancer and had received external beam radiation therapy (EBRT) prior to the implant. Overnight stay and a fractionated HDR brachytherapy course were used for patients who lived a long distance from our center, but had completed EBRT or where prior delays risked going over 56 days since start of therapy. Two immobilization balloons, 1 anterior to the ovoids to displace the bladder, and 1 posterior to the ovoids to displace the rectum, were positioned at the time of the implant under general anesthesia. Positioning was documented on the initial planning CT done immediately after the procedure and compared to a verification CT done the next morning before the second fraction was delivered for any movement or deflation of the balloons overnight.

Results: From 2012-2015, there were 6 patients with 10 T&O implants treated with HDR brachytherapy with an overnight stay. Immobilization balloons were contoured on both planning and verification CTs and total balloon volumes compared. Planning CT balloons ranged from 54.74cm3 to 84.81cm3. Verification CT balloons ranged from 53.39cm3 to 85.98cm3. Table 1 shows the percent difference for the 9 T&O implants between planning and verification CTs. There was 1 anterior balloon that was deflated on verification CT that was excluded from Table 1.

Conclusions: The use of immobilization balloons for T&O treatments on sequential days is practical and reliable. Only 1 balloon deflated, and this may have been intentional. The other balloons remained intact pushing the bladder and rectum out of the high-dose brachytherapy region. Contouring discrepancies may explain the volume increases for some balloons from planning to verification CTs. This procedure was well tolerated and explant was felt to be acceptable. This technique would be suitable for LDR brachytherapy over several days, and also is advantageous in avoiding traditional packing from slipping and giving suboptimal positioning.

Intended Use and Product Introduction:

The RadiaDyne® Alatus® Vaginal Balloon Packing System is designed to assist in positioning and displacing of the vaginal wall in a more predictable and reproducible location during the computed tomography (CT) exam and radiation treatment (RT) therapy. The product is packaged in a kit configuration which includes the following components to perform the procedure: Two (2) non-latex vaginal balloons, surgical lubricant, two (2) attachment clips, syringe, chart labels and instructions for use manual.

Indication For Use:

The RadiaDyne® Alatus® Vaginal Balloon Packing System is a single use, non-sterile, disposable,flexible, inflatable, non-powered positioning device, intended to be used on a daily treatment basis for the temporary positioning of the vaginal wall and adjacent structural anatomies. The purpose of the device is to displace and stabilize the vaginal wall during computed tomography (CT) exam, x-ray, or radiation treatment (RT) therapy. The placement of the balloon requires a physician or physician directed healthcare professional, and it is performed as a separate procedure outside of the standard (CT) exam and (RT) treatment. This device is not intended to be inserted into the uterine cavity.

Contraindications:

Vaginitis
Excessive vaginal bleeding
Any standard exclusionary criteria recognized for vaginal devices

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