Kamakshi R. Zeidler

Microsurgery education in residency training: validating an online curriculum.

Introduction:Plastic surgery training has traditionally been modeled as an “apprenticeship,” where faculty teach surgical skills to residents on live patients. Although this is a well-established process, the demand by the public and healthcare agencies for improved patient care, outcomes, and patient safety has led to the development of adjunct methods of teaching. The goal of this project is to assess the effectiveness of a web-based microsurgical curriculum. Methods:We developed an interactive Web site to teach essential microsurgical competencies. Residents were randomly divided into 2 cohorts: one experimental group completed this online resource and the other control group did not. Pre- and postassessments were administered, consisting of a written test and a recorded microsurgery skills session. Results:A total of 17 plastic surgery residents of various training levels participated in the study. Residents who completed the web-based curriculum showed dramatic improvement in their knowledge and skills, with a 17-percentage point increase in their test scores (P = 0.01) compared with controls (P = 0.80). The experimental group was more likely to perform microanastomoses faster with an average of 4.5-minute improvement compared with 1.25-minute change among the control group. Residents performed self-assessments, and those who rated themselves as “very confident” had higher overall test scores (85% test score vs. 59%, P = 0.004), as well as shorter times to complete the microsurgical task (7.5 minutes vs. 13.6 minutes, P = 0.007). Overall, 62% of residents rated the online webpage as extremely valuable. The majority of residents reported the webpage improved their knowledge and markedly improved their microsurgical technique, which was confirmed by faculty experts. Conclusions:Our interactive Web-based curriculum is a novel resource, teaching microsurgery in an organized, competency-based manner, which we believe is the first Web site of this nature. An individualized, self-paced Web site is ideal for plastic surgery trainees of all levels. Overall, the widespread implementation of our proposed curriculum—online self-directed training combined with regular practice sessions—will establish a strong foundation of microsurgery knowledge and skills acquisition for all plastic surgery residents.

Nine-Year Core Study Data for Sientra's FDA-Approved Round and Shaped Implants with High-Strength Cohesive Silicone Gel.

BACKGROUND Since approval in March 2012, data on Sientras (Santa Barbara, CA) silicone gel implants have been updated and published regularly to provide immediate visibility to the continued safety and performance of these devices. The 9 year follow-up data support the previously published data confirming the ongoing safety and efficacy of Sientra silicone gel breast implants. OBJECTIVES The authors provide updated 9 year study data for Sientras round and shaped silicone gel breast implants. METHODS The Core Study is an ongoing 10 year study that enrolled 1788 patients with 3506 Sientra implants across four indications (primary augmentation, revision-augmentation, primary reconstruction, and revision-reconstruction). For the safety analysis, Kaplan-Meier risk rates were calculated to evaluate postoperative complications, including all breast implant-related adverse effects. For the effectiveness analyses, results were presented through 8 years as patient satisfaction scores were assessed at even years. RESULTS Through 9 years, the overall risk of capsular contracture was 12.6%. Smooth devices (16.6%, 95% CI, 14.2%, 19.5%) had a statistically significantly higher rate of capsular contracture compared to textured devices (8.0%, 95% CI, 6.2%, 10.4%). Out of the 610 reoperations in 477 patients, over half of all reoperations were due to cosmetic reasons (n = 315; 51.6%). Patient satisfaction remains high through 8 years, with 90% of primary augmentation patients indicating their breast implants look natural and feel soft. CONCLUSIONS The 9-year follow-up data from the ongoing Core Study of the Sientra portfolio of HSC and HSC+ silicone gel breast implants reaffirm the very strong safety profile as well as continued patient satisfaction. LEVEL OF EVIDENCE 2 Therapeutic.

Eight-year follow-up data from the U.S. clinical trial for Sientra's FDA-approved round and shaped implants with high-strength cohesive silicone gel.

BACKGROUND On March 9, 2012, the Food and Drug Administration (FDA) approved Sientras premarket approval application for its portfolio of silicone gel breast implants based on their review of Sientras 3-year study data from the largest pivotal silicone gel breast implant study to date. This included the first approval of shaped breast implants in the United States. OBJECTIVES The authors provide an update to the 8-year safety and effectiveness of the Sientra High-Strength silicone gel breast implants. METHODS The Sientra Core study is an ongoing 10 year open-label, prospective, multi-center clinical study, which includes 1788 patients implanted with 3506 Sientra implants across four indications (Primary Augmentation, Revision Augmentation, Primary Reconstruction, and Revision Reconstruction). For the safety analysis, the incidence of post-operative complications, including all breast implant-related adverse effects (eg, infection, asymmetry), was estimated based on Kaplan-Meier risk rates. The effectiveness analyses include surgeon and patient satisfaction and changes in bra/cup size. RESULTS Through 8 years, the overall risk of rupture was 4.6%, the risk of capsular contracture was 11.8% (rates were lower when using True Texture™), and the risk of reoperation was 28.3%. Out of the 580 reoperations in 456 patients, over half of all reoperations were due to cosmetic reasons (n = 299). The most common reasons for reoperation were capsular contracture (19.0%), style and/or size change (18.4%), and asymmetry (8.8%). Patient satisfaction remains high through 8 years, with 87% indicating that their breast implants make them feel more feminine than prior to enrollment. CONCLUSIONS Safety data from the FDA Core study continues to support a comprehensive safety and effectiveness profile of Sientras portfolio of round and shaped implants through 8 years. LEVEL OF EVIDENCE 3 Therapeutic.

Long-Term Safety of Textured and Smooth Breast Implants

In this review, the authors provide a 20-year review and comparison of implant options and describe the evolution of breast implant surface textures; compare available implant surfaces; present long-term safety data from the 10-year US-based Core clinical studies; list the key benefits and risks associated with smooth and textured implants; and provide perspectives on breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). The authors explore the key benefits and risks associated with all available devices so that optimal and safe patient outcomes can be achieved.

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.

Teaching core competencies of reconstructive microsurgery with the use of standardized patients.

AbstractThe Accreditation Council of Graduate Medical Education has defined 6 core competencies that residents must master before completing their training. Objective structured clinical examinations (OSCEs) using standardized patients are effective educational tools to assess and teach core competencies. We developed an OSCE specific for microsurgical head and neck reconstruction. Fifteen plastic surgery residents participated in the OSCE simulating a typical new patient consultation, which involved a patient with oral cancer. Residents were scored in all 6 core competencies by the standardized patients and faculty experts. Analysis of participant performance showed that although residents performed well overall, many lacked proficiency in systems-based practice. Junior residents were also more likely to omit critical elements of the physical examination compared to senior residents. We have modified our educational curriculum to specifically address these deficiencies. Our study demonstrates that the OSCE is an effective assessment tool for teaching and assessing all core competencies in microsurgery.

AeroForm patient controlled tissue expansion and saline tissue expansion for breast reconstruction: a randomized controlled trial.

BackgroundProsthetic reconstruction of the breast, as a 2-staged procedure using tissue expanders followed by placement of permanent implants, offers favorable aesthetic results with minimal additional surgical intervention. However, the current outpatient process to fill saline expanders can be lengthy and onerous, involving months of office visits and discomfort from the bolus saline expansions. We present a new technology (AeroForm Tissue Expansion System), which has the potential to improve the process of breast tissue expansion by providing a method for low-volume incremental filling, eliminating the need for injections and directly involving the patient by allowing her some control over the expansion process. MethodsThe described study is a 2:1 randomized controlled trial of the investigational CO2 expansion system and saline expanders. Of the 82 women receiving expanders, 58 (39 bilateral and 19 unilateral; bilateral rate, 67%) were implanted with CO2 tissue expanders and 24 subjects (15 bilateral and 9 unilateral; bilateral rate, 63%) were implanted with saline expanders. ResultsPreliminary validated expansion results were available for 55 women. Available mean time for active expansion in the CO2 group was 18.2 (9.2) days (median, 14.0; range, 5–39; number of expanders, 53), which was less than the mean time for active expansion in the saline group: 57.4 (33.6) days (median, 55; range, 5–137; number of expanders, 33). Available mean time from implant placement to exchange for a permanent prosthesis in the CO2 group was shorter [106.3 (42.9) days; median, 99; range, 42–237; number of expanders, 53] than for the women in the control group [151.7 (62.6) days; median, 140; range, 69–433; number of expanders, 33]. After 2 events—underexpansion (n = 1) and erosion (n = 1)—in the CO2 group, the internal membrane was redesigned and the expander bulk was decreased to minimize the risk of underexpansion and erosion in subsequent patients. ConclusionsPreliminary evidence indicates that the CO2-based tissue expansion system performs the same function as saline expansion devices without significantly altering the risk to the patient and that the device has the potential to make the expansion process faster and more convenient for both the patient and the physician.

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.

The Matrix Rib Plating System: improving aesthetic outcomes in microvascular breast reconstruction.

IntroductionDuring microvascular breast reconstruction, exposure of internal mammary vessels (IMVs) is facilitated by the removal of a portion of the rib resulting in occasional chest contour deformity (CCD). The use of rib plating may reduce CCD and reduce postoperative pain. MethodsAll patients underwent microvascular breast reconstruction using IMVs. In the retrospective arm, photographs were assessed by a blinded reviewer for CCDs. In the prospective cohort, patients were randomized to rib plating with the Synthes Matrix Rib Plating System or no rib plating. Postoperatively, patients were assessed for CCD and pain. ResultsIn the retrospective arm, 11 of 98 (11.2%) patients representing 12 of 130 (9.2%) breast reconstructions had a noticeable contour deformity. The average body mass index (BMI) of patients with CCDs was 26.6 kg/m2. In the prospective arm, there was 16% (3 of 19) rate of visible and palpable CCDs among controls, compared to 0% rate of palpable and visible contour deformity in the rib plating group. Pain was decreased in the rib plating group on all postoperative days. The pain reduction was statistically significant at rest by postoperative day 30. ConclusionThe majority of patients (9 of 11) with compromised aesthetic outcomes had a BMI less than 30 kg/m2, suggesting a paucity of overlying soft tissue contributed to visibility of these bony defects. Rib plating prevented chest contour deformity, reduced postoperative pain, and added limited additional morbidity. We believe that rib plating is a safe, useful adjunct to microvascular breast reconstruction using IMVs, as it may improve aesthetic outcomes and reduce postoperative pain.

Aeroform vs Saline Tissue Expansion in Breast Reconstruction: A Prospective Multi-Center Randomized Controlled Clinical Study.

Jeffrey A. Ascherman, MD; Adam Jacoby, MD; Kaveh Alizadeh, MD, FACS; James Appel, MD; R. Laurence Berkowitz, MD; John Castle, MD; Yoon S. Chun, MD; Amy S. Colwell, MD; Ankit R. Desai, MD; Susan E. Downey, MD; Gregory Evans, MD, FACS; Michael Fallucco, MD; Terri Halperin, MD; Scott Hollenbeck, MD; Debra J. Johnson, MD; Khashayar Mohebali, MD; Donald Morris, MD; Tracey Stokes, MD; Laura A. Sudarsky, MD; Kamakshi R. Zeidler, MD