PatientActivated Controlled Expansion for Breast Reconstruction Using Controlled

Patient-Activated Controlled Expansion for Breast Reconstruction Using Controlled Carbon Dioxide Inflation: Confirmation of a Feasibility Study Tony F. Connell, F. R. A. C. S. Subiaco, Western Australia, Australia Received for publication December 13, 2013; accepted March 17, 2014. (www. prsjournal. com). GEBERT Ludwig

Introduction • Indication : • “women with breast cancer in situ” (traitement curatif) • “at high risk of developing breast cancer because of the presence of BRCA 1 or BRCA 2 gene mutations or with a familial history of the disease” (traitement prophylactique) • Intérêt : “Reconstruction of the breast” • “tissue expanders followed by implants” • “autologous flaps, with formation of an expanded pocket using a breast tissue expander” • “or with a combination of these techniques” • Méthode actuelle : “saline tissue expander, … The patient undergoes a series of bolus injections of saline through a magnetic port embedded in the expander” • Méthode testée : “the Aero. Form tissue expander and handheld dosage controller”

Introduction • Objectif principal : “expansion to and maintenance of clinically desired breast volume until permanent implant placement unless prohibited by a non–device-related failure” • Objectifs secondaires : “the time to achieve desired expansion and placement of a permanent implant, safety, and overall subject and physician satisfaction”

Matériels et Méthodes • Type d’étude : “prospective, open-label, single-arm” • Population : “Thirty-three enrollees signed informed consent and were treated in this clinical investigation at Mount Hospital, Perth, Western Australia. The majority of subjects underwent bilateral implantation (n = 28), with a total of 61 implants in the population of 33 women. ”

Matériels et Méthodes

Matériels et Méthodes • Critère de jugement principal : “The primary endpoint of this study was analyzed per breast (expander). The device performance was reported based on the subset of enrolled subjects who met the primary endpoint or failed expansion because of a device malfunction. ” • Critères secondaires : • • “time to expansion, time to permanent implant exchange, adverse events, device-related adverse events, patient and physician satisfaction. ”

Résultats • Groupe : “Recruitment of 33 subjects occurred from July of 2011 to June of 2012. Twenty-six (79 percent) had immediate reconstruction, three (9 percent) had delayed reconstruction, and four (12 percent) had immediate reconstruction with delayed reconstruction on the contralateral side. • Bilateral reconstructions [n = 28 (85 percent)] were predominant, with 61 total breast reconstructions completed. ” • “Three subjects had a history of radiation therapy. ” • “Two subjects were given a waiver to fly within Australia and did so without any adverse expansion consequences. ” • •

Résultats

Résultats • Critère principal : “expansion to and maintenance of clinically desired breast volume until permanent implant placement unless prohibited by a non– device-related failure, was met in 100 percent (61 of 61) of the expanders. ”

Résultats • Critères secondaires : • “The mean number of days for the patients to achieve desired and full expansion was 17 ± 5 days. • Total mean reconstruction time was 90 ± 18 days. ” • “Subjects were asked to complete an ease-ofuse questionnaire : • 31 of 32 responding subjects (97 percent) indicated that the dosage controller was “very easy to use” • one (3 percent) respondent described it as “moderately easy to use. ” • In terms of the overall results of their expansions, • 26 (81 percent) responded that they were “very satisfied, ” • four (13 percent) were “moderately satisfied, ” • and two (6 percent) were “satisfied” with their expansion process. ”

Résultats • Critères secondaires : • “The surgeon incorporated latissimus dorsi pedicle flap procedures in all 61 reconstructions. ” • “Intraoperatively, the surgeon dosed the expanders an average of 65 cc of carbon dioxide and described the majority of his intraoperative experience operating the dosage controller as “very easy” (94 percent of the cases) and a minority as “moderately easy” (6 percent). • He also described his experience implanting the expander as “very easy” (61 percent) to “moderately easy” (39 percent). • Lastly, he rated his overall satisfaction with the use of the tissue expander system as “very easy” (97 percent). ”

Résultats • Critères secondaires : • “All reported events are those that are typically associated with breast reconstruction and reported in the literature. ”

Résultats

Conclusion This study represents progress toward the goal of improving the quality of care for women undergoing the arduous process of breast reconstruction.

Discussion • “In this series, 61 tissue expanders were successfully implanted and exchanged for permanent implants in 33 subjects. ” • “It is known that the volume in the Aero. Form expander will increase at higher altitudes during ascent because of expansion of the carbon dioxide… Because of this, it is recommended that the patient discontinue dosing before the flight to allow permeation to occur… it is necessary to confirm that her incision is well healed, tissue perfusion is intact, and she is comfortable before the planned flight. ”

Discussion • “The total mean reconstruction time was 3 months, which compares favorably to the typically longer reconstruction time frame of up to 6 months or longer with standard saline tissue expanders. ” • “These characteristics of the Aero. Form device were further demonstrated in the larger population by means of the results of an ease-of-use questionnaire administered after expansion was complete. ” • “Bench testing measured the permeation rate (1 to 1. 5 cc/day) in the enhanced version of the device. ” • “As with all tissue expanders, the Aero. Form is intended for implantation for up to 6 months. ”

Discussion • Limites : • “Limitations of this trial include the single-site, single-surgeon experience with the same surgical technique used for all subjects. • Inability to remove carbon dioxide from the device remains a concern; • use of radiotherapy with the device and the preclusion of traveling to an altitude above 1000 m. ” • “Further investigation is necessary to better characterize these limitations with the device before commercial use. ”

Discussion: Patient-Activated Controlled Expansion for Breast Reconstruction Using Controlled Carbon Dioxide Inflation: Confirmation of a Feasibility Study Peter G. Cordeiro, M. D. New York, N. Y. Received for publication April 15, 2014; accepted April 17, 2014. (www. prsjournal. com). GEBERT Ludwig

Salin Expander vs Aeroform expander • « Some expand slowly, with intervals between expansions ranging up to 4 weeks, whereas others use a much more rapid approach. My personal preference has been to use early/rapid expansion (starting at days 10 to 14, with weekly expansions ranging from 60 to 120 cc). » • « However, the clear disadvantage of weekly (or monthly) expansion with saline is the fact that the patient needs to return to the plastic surgeon multiple times. In addition to being disruptive to the patient’s schedule, this is also work-intensive for plastic surgeons and their staff. Moreover, patients can experience varying degrees of discomfort and pain during each expansion. » • « The clear advantage of the patient-activated controlled expansion approach using carbon dioxide is the fact that patients control their own expansions, which could eliminate or decrease the number of postoperative visits to the plastic surgeon. » • « The small volume of expansion on a thrice-daily basis is more comfortable for the patient, and maintaining control over the entire procedure also likely adds to overall patient satisfaction. »

But • « First, although safety has been demonstrated in these 33 patients, this is a very small cohort. The possibility of complications such as uncontrolled expansion caused by device failure, in addition to extrusion and flap necrosis, certainly exists. Larger randomized studies need to be performed to demonstrate the true efficacy and safety of these devices. • Patients with these devices may not ascend greater than 1000 feet or fly in an airplane for fear of overexpansion. Locking out inflation before flying to decrease the overall volume partly addresses this problem. • The persistent diffusion of carbon dioxide through the membrane of the implant (permeation) and the need to provide “maintenance dosing” makes it impossible to accurately assess the volume of the air-filled tissue expander at the time of the exchange and difficult to estimate what implant sizes to order. The amount of extra air available to compensate for loss because of permeation is approximately two times the volume of the expander, allowing for only approximately a 6 -month maximum time of implantation. Oncologic therapy may require leaving a tissue expander in place for well over 6 months. »

Conclusion • « Finally, other limitations of this study include the small number of patients, the lack of a control group, and the fact that all patients underwent latissimus flap reconstruction with placement of a tissue expander. » • « Larger, randomized, controlled studies using a multicenter approach should be pursued. Innovations in design and manufacturing of the device will certainly improve its overall utility, safety, and efficacy. »