XPAND Patient-Activated Controlled Tissue Expander System for Breast Reconstruction

Ascherman, Jeffrey A.; Castle, John; Colwell, Amy S.; Chun, Yoon S.; Evans, Gregory R. D.; Johnson, Debra; Morris, Donald J.; Berkowitz, Richard L.; Desai, Ankit R.; Alizadeh, Kaveh; Hollenbeck, Scott T.; Appel, James Z.; Thornton, Brian P.; Mohebali, Khashayar; Spiegel, Aldona J.; Downey, Susan E.; Zeidler, Kamakshi R.

doi:10.1097/01.prs.0000455443.43132.00

Cited by 6 publications

(12 citation statements)

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“…Importantly, carbon dioxide-based devices are not immune to many complications also seen in saline-based expansion, including infection, delayed wound healing, and seroma formation, all of which we have been seen in both the Patient Activated Controlled Expansion trials and preliminary AirXpanders Patient Activated Controlled Tissue Expander data. 11,12 Although the incidents of overexpansion within the experimental device group were concerning, this complication has not occurred with the most current version of the device. Another limitation of device use is the inability to decrease expander size in the event of patient discomfort or concern over mastectomy flap ischemia, whereas saline can easily be removed from traditional devices.…”

Section: Discussionmentioning

confidence: 80%

“…12 In the data reported at the recent American Society of Plastic Surgeons 2014 meeting, 99 percent of patients reported using the patient-controlled expander as "very easy," 97 percent described the process of expanding at home as "very convenient," and 85 percent would recommend the device to others, indicating an overall extremely positive experience with this new device. 12 The most common complication associated with device use was delayed wound healing, but this was similarly prevalent in the control group (12 percent versus 9 percent, respectively), whereas underexpansion and overexpansion were reported rarely. These overexpansions all occurred in doctors' offices and required immediate needle deflation, as the valve opening had become obstructed because of accumulation of an aluminum precipitate, resulting in a continuous release of carbon dioxide.…”

Section: Human Datamentioning

confidence: 94%

“…12 To date, since 2011, we have enrolled 34 patients using 36 experimental devices in total at Columbia, and have also found significantly shorter expansion and overall reconstruction times in the patient-controlled tissue expander group. Every patient in our Columbia experimental group has recommended the device for others, and all patients except for one were satisfied with carbon dioxide-based tissue expansion.…”

Section: Columbia University Experiencementioning

confidence: 97%

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Carbon Dioxide versus Saline Tissue Expanders

Ascherman

Zeidler

Jacoby

et al. 2016

Plastic and Reconstructive Surgery

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Section: Discussionmentioning

confidence: 80%

Section: Human Datamentioning

confidence: 94%

Section: Columbia University Experiencementioning

confidence: 97%

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Carbon Dioxide versus Saline Tissue Expanders

Ascherman

Zeidler

Jacoby

et al. 2016

Plastic and Reconstructive Surgery

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“…Saline tissue expansion has certain disadvantages such as patient discomfort and anxiety associated with repeated percutaneous needlesticks, disruption of work or daily activity, the possibility for introducing bacterial inoculum percutaneously during fills, consumption of office/physician resources as well as the risk of rupture. 13…”

Section: Introductionmentioning

confidence: 99%

Two-stage Prosthetic Prepectoral Breast Reconstruction: Comparing Tissue Expansion with Carbon Dioxide and Saline

Chopra

Singh

Hricz

et al. 2019

Plastic and Reconstructive Surgery - Global Open

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Background: The AeroForm tissue expander is a carbon dioxide-filled breast tissue expander that allows gradual, needle-free expansion using a hand-held remote controller. This study evaluates 2-stage, prepectoral tissue expander-to-implant breast reconstruction with the carbon-dioxide tissue expanders and compares the outcomes to our recent experience with saline tissue expanders. Methods: This was a retrospective study of consecutive patients from a single institution. The subjects consisted of women who underwent mastectomy and either immediate or delayed breast reconstruction with AeroForm or saline tissue expanders. Outcomes encompassed postoperative complications including mastectomy flap necrosis, infection requiring readmission and/or intravenous antibiotics, capsular contracture, hematoma, seroma, skin dehiscence, extrusion, premature explant, and loss of communication with the device (AeroForm) or rupture of the device (saline). Results: This study evaluated 115 patients with 185 breast reconstructions. Of the 185 breast reconstructions, 74 (40%) utilized AeroForm tissue expanders and 111 (60%) utilized traditional saline tissue expanders. Treatment was successful in 100% and 94% in the AeroForm and saline groups, respectively ( P = 0.025). The incidence of adverse events was greater in the saline group (45.9% versus 32.4%). Surgical-site infection occurred more commonly in the saline group (5.4% versus 0%). Full-thickness skin necrosis occurred at a significantly higher rate in the saline cohort as compared with AeroForm (5.4% versus 0%). Conclusions: The use of AeroForm tissue expanders offers notable advantages for breast reconstruction. This device when employed in the prepectoral space may be associated with reduced infection rates and decreased utilization of healthcare and patient resources.

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“…Saline tissue expansion has certain disadvantages such as patient discomfort and anxiety associated with repeated percutaneous needlesticks, disruption of work or daily activity, the possibility for introducing bacterial inoculum percutaneously during fills, consumption of office and physician resources, and the risk of rupture. 8…”

Section: Introductionmentioning

confidence: 99%

Cost Utility of Breast Tissue Expansion using Carbon Dioxide versus Saline: An Analysis of Infection Risk

Chopra

Slavin

Khavanin

et al. 2019

Plastic and Reconstructive Surgery - Global Open

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Background:The AeroForm System, a needle-free, patient-controlled carbon dioxide-filled tissue expander, represents a novel option for tissue expansion in 2-stage breast reconstruction. This technology has previously been found to decrease time to expansion, health-care utilization, and infection rates. The purpose of this study was to determine the economic impact of the reduced infection rate observed with the AeroForm tissue expander as compared with saline tissue expansion.Methods:A decision model incorporating costs, quality-adjusted life years, and clinical outcomes of infection was designed to evaluate the cost-efficacy of AeroForm tissue expanders versus conventional saline expanders. All statistical calculations were performed in the R statistical computing environment.Results:Pooled infection rates from the published literature following saline and AeroForm tissue expander placement were 5.83% and 2.62%, respectively. Cost-utility analysis resulted in a baseline expected savings of $253.29 and an expected gain of 0.00122 quality-adjusted life years with AeroForm tissue expanders. One-way sensitivity analysis revealed that AeroForm tissue expanders were dominant when the surgical site infection rate was greater than 4.56% with traditional saline expanders.Conclusions:Clinical benefits of an innovation are no longer sufficient to justify its acquisition costs. Novel technologies must also demonstrate favorable economic outcomes. This cost-utility analysis demonstrates that the use of AeroForm expanders is likely a cost-saving technology for 2-stage breast reconstruction.

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XPAND Patient-Activated Controlled Tissue Expander System for Breast Reconstruction

Cited by 6 publications

References 0 publications

Carbon Dioxide versus Saline Tissue Expanders

Carbon Dioxide versus Saline Tissue Expanders

Two-stage Prosthetic Prepectoral Breast Reconstruction: Comparing Tissue Expansion with Carbon Dioxide and Saline

Cost Utility of Breast Tissue Expansion using Carbon Dioxide versus Saline: An Analysis of Infection Risk

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