The Impact of Device Innovation on Clinical Outcomes in Expander-based Breast Reconstruction

Abstract

Background: Staged expander-based breast reconstruction represents the most common reconstructive modality in the United States. The introduction of a novel tissue expander with an integrated drain (Sientra AlloX2) holds promise to further improve clinical outcomes. Methods: Patients who underwent immediate expander-based pre-pectoral breast reconstruction were identified. Two cohorts were created, that is, patients who underwent placement of a conventional tissue expander [133MX (Allergan)] (Group 1) versus AlloX2 (Sientra) (Group 2). The study endpoint was successful completion of expansion with the objective being to investigate differences in outcome following expander placement. Results: Fifty-eight patients underwent 99 breast reconstructions [Group 1: N = 24 (40 breasts) versus Group 2: N = 34 (59 breast)]. No differences were noted for age (P = 0.586), BMI (P = 0.109), history of radiation (P = 0.377), adjuvant radiotherapy (P = 1.00), and overall complication rate (P = 0.141). A significantly longer time to drain removal was noted in Group 1 (P < 0.001). All patients with postoperative infection in Group 1 required surgical treatment versus successful washout of the peri-prosthetic space via the AlloX2 drain port in 3 of 5 patients in Group 2 (P = 0.196). Furthermore, both cases of seroma in Group 1 required image-guided drainage versus in-office drainage via the AlloX2 drain port in 1 patient in Group 2 (P =0.333). Conclusion: The unique feature of the AlloX2 provides surgeons easy access to the peri-prosthetic space without altering any of the other characteristics of a tissue expander. This resulted in a reduced time to drain removal and facilitated management of postoperative seroma and infection.

Advances in Tissue Expander Technology Enable Early Targeted Intervention in Prepectoral Breast Reconstruction

“…The ability to drain periprosthetic fluid with ease not only permits treatment of postoperative seroma, but also allows aspirated fluid to be sent for culture. While the ability to use the integrated drain of the AlloX2 TE for periprosthetic washouts, and thus, successfully treating select patients with periprosthetic infections without surgical intervention have been previously reported, 7 , 18 , 19 the value of having knowledge of the microbiological makeup of the periprosthetic fluid in an asymptomatic patient became evident in a patient who went on to develop surgical site infection. Having knowledge of the presence of Actinomyces neuii permitted initiation of targeted antibiotic therapy without delay, thus, avoiding a trial with broad-spectrum antibiotics and permitting salvage of the device without surgical intervention.…”

“…Thus, early recommendations included maintaining drains for at least 3 weeks following prepectoral reconstruction 6 ; the advent of novel technology, however, has permitted earlier drain removal while permitting access to the periprosthetic space, allowing for aspiration of periprosthetic fluid following drain removal. 7 …”

Toward Drainless Breast Reconstruction: A Pilot Study

“…The innovative design of this expander has been identified by other groups, proving the utility of this device. 7 , 8 Expanding upon the Ziedler study, Franck et al utilized dual-port expanders, comparing a cohort with and without drains to show the feasibility of the technique, but did not have patient-reported outcomes. 9 …”

“…The innovative design of this expander has been identified by other groups, proving the utility of this device. 7,8 Expanding upon the Ziedler study, Franck et al utilized dual-port expanders, comparing a cohort with and without drains to show the feasibility of the technique, but did not have patient-reported outcomes. 9 In an effort to demonstrate the feasibility of avoiding drains with this new type of tissue expander, along with an emphasis on patient satisfaction, we conducted a pilot study with five consecutive patients.…”

Preoperative β‐lactam antibiotic prophylaxis is superior to bacteriostatic alternatives in immediate expander‐based breast reconstruction

“…Over the past five decades, substantial advancements in surgical technique and technology have translated into improvements in clinical outcomes following staged implant‐based breast reconstruction 1,2 . These improvements, in addition to federal legislation and increased public awareness, have resulted in an over 35% increase in the number of breast reconstructions being performed annually in the United States since the year 2000 3 .…”