Results of XPAND II: A Multicenter, Prospective, Continued-Access Clinical Trial Using the AeroForm Tissue Expander for Two-Stage Breast Reconstruction.

BACKGROUND: XPAND II was a prospective, multicenter, single-arm, open-label, continued-access study designed to confirm the results from the XPAND study, a multicenter, prospective, randomized study for breast reconstruction. The AeroForm device received clearance from the U.S. Food and Drug Administration in December 2016 based on the results of the pivotal XPAND trial, which compared the AeroForm to saline expanders. METHODS: Fifty women were treated in the XPAND II study and implanted with the AeroForm device (86 devices). The study endpoint was successful completion of the second-stage surgery, and secondary endpoints were days to complete expansion and reconstruction, and patient/physician satisfaction. Following implantation, women were administered 10-cc doses of carbon dioxide at home up to three times daily. When adequate expansion was achieved, the expanders were exchanged for standard breast implants. RESULTS: The primary endpoint (successful exchange to standard breast implant, precluding non-device-related failures) is 100 percent. All-cause interim success is 95 percent, with three subjects (four breasts) failing primary exchange because of non-device-related reasons. Median time to complete expansion was 21 days (range, 5 to 117 days). Median time to complete the reconstruction was 112 days (range, 55 to 329 days). Ninety-six percent of the subjects were very or moderately satisfied with the AeroForm expansion process. CONCLUSIONS: Results of the XPAND II continued access study confirm and improve on previous results from the randomized trial (XPAND). These results validate that the AeroForm patient-controlled, needle-free carbon dioxide tissue expander is safe and effective for two-stage breast reconstruction. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, IV.

Breast Implant Engineering and Performance.

The engineering of breast implants for both augmentation and reconstruction is centered on facilitating optimal aesthetic results pleasing to the patient, while minimizing both short- and long-term complications. Some of the key individual design elements that have been the primary focus over time have included gel cohesivity, shell thickness, shell surface, and implant gel fill. A review of these separate elements points to the potential benefits of increased focus on a combined overall performance perspective for engineering of new implants as exemplified in the recently introduced MemoryGel Xtra Breast Implants. Such an approach is expected to provide an improved and expanded range of options to facilitate obtaining desired aesthetic outcomes and long-term clinical performance.

Carbon Dioxide versus Saline Tissue Expanders: Does It Matter?

BACKGROUND: Implant-based breast reconstruction is the most common reconstructive technique in the United States. Despite its popularity, saline-based tissue expansion still has its limitations, including lengthy expansion times, large uncomfortable bolus dosing, and frequent percutaneous injections/expansion visits. Ideally, a novel technology would eliminate frequent, percutaneous saline injections and allow patients to perform expansion at home, reducing the disruptive experience of current tissue expansion. METHODS: Within the past 6 years, the AeroForm tissue expander system has used remotely activated carbon dioxide release as the fill medium instead of saline, eliminating many limitations of traditional tissue expanders. In this article, the authors first review the relevant literature concerning carbon dioxide-based tissue expansion in animal and human models. The authors then analyze the similarities and differences between two groundbreaking human trials (i.e., Patient Activated Controlled Expansion and AirXpanders Patient Activated Controlled Tissue Expander) with carbon dioxide-based expanders and discuss the risks and benefits associated with this new technology. RESULTS: At their site, the authors have enrolled 34 patients using 36 experimental devices in total, and have found significantly shorter expansion and overall reconstruction times in the patient-controlled tissue expander group. CONCLUSIONS: The authors believe that carbon dioxide-based devices may play a significant role in the future of implant-based breast reconstruction, and may be widely applicable to other areas of plastic surgery that also involve tissue expansion.

Carbon Dioxide-Based versus Saline Tissue Expansion for Breast Reconstruction: Results of the XPAND Prospective, Randomized Clinical Trial.

BACKGROUND: AeroForm is a new type of remote-controlled, needle-free, carbon dioxide-based expander involving a potentially faster method of tissue expansion. Results are presented here from the AirXpanders Patient Activated Controlled Tissue Expander pivotal trial comparing AeroForm to saline tissue expanders. METHODS: Women undergoing two-stage breast reconstruction were randomized at 17 U.S. sites in this U.S. Food and Drug Administration-approved investigational device exemption trial. Expansion in the investigational arm was performed by the patient in 10-cc increments up to 30 cc/day of carbon dioxide and in the control arm by the physician with periodic bolus injections of saline. Safety endpoints, expansion and reconstruction times, pain, and satisfaction were assessed. RESULTS: One hundred fifty women were treated: 98 with carbon dioxide expanders (n = 168) and 52 with saline expanders (n = 88). The treatment success rate (all breasts exchanged successfully excluding non-device-related failures) was 96.1 percent for carbon dioxide and 98.8 percent for saline. Median time to full expansion and completion of the second-stage operation was 21.0 and 108.5 days (carbon dioxide) versus 46.0 and 136.5 days (saline), respectively, with a similar rate of overall complications. Ease of use for the carbon dioxide expander was rated high by patients (98 percent) and physicians (90 percent). CONCLUSIONS: The AirXpanders Patient Activated Controlled Tissue Expander trial results demonstrate that a carbon dioxide-based expander is an effective method of tissue expansion with a similar overall adverse event rate compared to saline expanders, and provides a more convenient and expedient expansion. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, I.

Preventing alar retraction by preservation of the lateral crus.

BACKGROUND: Resecting the cephalic component of the lateral crus in an attempt to reduce tip bulbosity has the potential to aggravate and/or cause alar retraction. It is a more serious problem for those patients who exhibit borderline alar retraction. METHOD: Fourteen primary rhinoplasty patients with borderline alar/columellar relationships for alar retraction formed the study. They did not warrant frank treatment of alar retraction but did exhibit tip bulbosity. An "island" of cephalic lateral crus was developed by an intercartilaginous incision and another 6 mm cephalic to the caudal border of the lateral crus. One or more mattress sutures were placed in the main body of the lateral crus to stiffen and straighten it. The "island" of cephalic crus was then slipped under the main body of the lateral crus. RESULTS: At 11 months to 2(1/2) years, 13 of the 14 patients demonstrated no significant change in their preoperative alar/columellar relationships. Bulbosity was corrected in all patients. One patient, however, required a revision using an alar contour rim graft. The mean preoperative alar-nostril axis measurement was 1.48 mm (range, 1.3 to 1.9 mm) in contrast to a mean postoperative measurement of 1.71 mm (range, 1.5 to 2.2 mm). A one-tailed paired t test indicated no statistically significant difference between preoperative and postoperative values. CONCLUSIONS: The cephalic part of the lateral crus can act as a lateral crural strut to maintain the ala in a more caudal position. The technique is useful for borderline alar retraction and when lengthening the short nose for which there is a need to preserve side wall length.

Open incisional hernia repair at an academic tertiary care medical center.

OBJECTIVE: To describe the postoperative complication rates of a large consecutive series of patients who underwent open incisional ventral hernia repair. DESIGN: Retrospective medical record review of an accumulated database. SETTING: University tertiary care medical center. PATIENTS: All patients who underwent open incisional ventral hernia repair from March 1, 2003, through February 28, 2008. INTERVENTION: Open incisional ventral hernia repair. MAIN OUTCOME MEASURES: Postoperative complications, including hernia recurrences. RESULTS: A total of 507 cases (465 patients; female to male ratio, 1.1:1) met our criteria; median follow-up was 40 months. In 23.5% of the cases, repair had been attempted previously, and 16.4% had previously undergone organ transplant. The postoperative complication rate was 38.1%. Hernias recurred in 18.9% of cases. Perioperative mortality was 1.0%. Patients undergoing transplant were more likely than those not undergoing transplant to have a hernia recurrence (16.3% vs 32.5%; P < .001) and were equally likely to have a postoperative complication (36.9% vs 44.6%; P = .19). Patients who underwent repair of a recurrent incisional hernia were as likely to have a hernia recurrence as those who underwent initial repair (21.0% vs 18.3%; P = .52) but more likely to have an overall complication (47.9% vs 35.1%; P = .01). CONCLUSIONS: In this series of incisional hernia repairs at a tertiary care center, the overall recurrence rate of 18.9% is comparable to that of other published series. Ours is the largest published series of recurrent hernias that shows a recurrence rate comparable to that for initial repairs. This outcome may be the result of greater use of more complex repair techniques.

Reactive oxygen species and EGR-1 gene expression in surgical postoperative peritoneal adhesions.

Postoperative peritoneal adhesions are common and serious complications of general abdominal and gynecological surgery that can lead to chronic abdominal pain, small-bowel obstruction and infertility. The specific pathophysiology of peritoneal adhesions remains elusive and current treatment is relegated to prevention through meticulous surgical technique and protective physical barriers, gels and solutions. We have reported that reactive oxygen species (ROS), generated by phagocytic cells at the site of tissue injury, serve as major signaling molecules regulating the expression of vascular endothelial growth factor (VEGF) and subsequent wound repair. We hypothesized that peritoneal adhesions are a product of over-healing surgical wounds and that, like in wound healing, ROS are implicated in their pathogenesis. We examined the presence of footprints of ROS and the ROS-inducible angiogenic factor VEGF in human adhesion tissue. An experimental model of peritoneal adhesion was established in rodents to study of the dynamics of ROS-induced gene expression during de novo adhesion tissue formation. Immunohistochemical analysis demonstrated presence of ROS/oxidant and macrophages in human peritoneal tissue. The presence of ROS and ROS-sensitive transcription factor EGR-1 was also evident in an experimental rodent peritoneal adhesion model. Along with ROS, VEGF, and a large number of mature and immature CD31/vWF positive blood vessels were present in the adhesion tissue. These observations are not consistent with the contention that adhesions are non-functional scar tissue. The newly developed rodent model of adhesion may present a useful approach to reproducibly and objectively study molecular mechanisms underlying the dynamic process of de novo adhesion tissue formation.