Kaveh Alizadeh

Free-flap reconstruction in the doubly irradiated patient population.

Background: The standard of care for previously irradiated, unresectable, recurrent head and neck cancer has been chemotherapy alone. High-dose reirradiation with concomitant chemotherapy represents a more aggressive approach to these tumors and has afforded encouraging results with an increased fraction of long-term survivors. After reirradiation, these patients commonly present with extensive tissue loss, nonhealing wounds, contractures, and fistulas, and free-flap reconstruction is often necessary to correct the perils of oncologic treatment. Methods: A 9-year retrospective review of 35 patients who required surgical intervention following a second round of chemoradiation was performed. Thirty-three free flaps were performed on 24 patients, and total radiation given before free tissue transfer ranged from 100 to 200 Gy. Indications for free-flap reconstruction included soft-tissue necrosis (15 of 33), tumor ablation (seven of 33), osteoradionecrosis (six of 33), oral incompetence (three of 33), tracheal perforation (one of 33), and esophageal stricture (one of 33). Results: Free tissue transfer was successful in 94 percent (31 of 33) of flaps, with an overall major complication rate of 66 percent (23 of 35). Wound dehiscence (15 percent), infection (15 percent), hematoma (12 percent), fistula formation (12 percent), partial flap necrosis (9 percent), and total flap necrosis (6 percent) were the most commonly seen complications. Conclusions: Although complications are common, free tissue transfer offers the difficult reirradiated patient a successful means of wound rehabilitation. The ultimate success of closing these wounds allows for aggressive oncologic treatment, which possibly will facilitate improved survival in this patient population that struggles with a dismal overall prognosis.

Ear reconstruction after auricular chondritis secondary to ear piercing.

The recent fad of high ear piercing in the pinna has led to an increased incidence of auricular chondritis, which leads to dissolution of the cartilage and residual ear deformity. The typical postpiercing chondritis deformity presents as a structural collapse of the superior helical rim, scaphal cartilage, and the adjacent antihelix. The skin envelope is usually preserved, but it may be scarred from the infectious process and from previous drainage incisions. In the present article, the authors present a systematic approach to reconstruction of these acquired ear deformities. Careful assessment of the residual tissue is requisite to planning and appropriate reconstruction. The greater the cartilage loss, the more structural support is required to expand the skin envelope to its normal size and shape. The choice of cartilage donor site is made on the basis of the size of the defect and may include ipsilateral or contralateral conchal cartilage, bilateral conchal cartilage, or costal cartilage. Redraping of the carefully dissected skin and fixation of the flaps to the newly reconstructed cartilaginous framework usually provide sufficient soft-tissue coverage. A temporal-parietal fascial flap is preserved for the rare cases of extensive full-thickness skin loss or badly damaged and scarred auricular skin.

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.

Spacer Facial Artery Musculomucosal Flap: Simultaneous Closure of Oronasal Fistulas and Palatal Lengthening.

Summary: In this series, the authors describe a modification of the facial artery musculomucosal flap for oronasal fistula repair. The spacer facial artery musculomucosal flap technique is characterized by a pedicle inset into the retromolar trigone and palate, obviating a second operative stage. This was performed in 14 patients with a 5.2-cm2 mean fistula size. Average follow-up was 4.3 years, with one partial flap necrosis but no recurrent oronasal fistula. There was a mean decrease of 18 percent in the distance between the velum and the posterior pharyngeal wall. The spacer facial artery musculomucosal flap provides a single-stage reconstruction of oronasal fistula while lengthening the palate through a pushback mechanism. Although further study of velopharyngeal function is needed, the spacer facial artery musculomucosal flap may be beneficial for patients with a short velum and an oronasal fistula. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, IV.

Sientra Primary and Revision Augmentation Rupture Trending and Analysis with Magnetic Resonance Imaging

BACKGROUND Rupture of silicone gel breast implants is a rare occurrence but remains one of the key surgical concerns. The objective of this article was to provide visibility and information on trends for the impact that patient and surgical characteristics play in the occurrence of rupture. OBJECTIVES Examine trends in surgical techniques to better understand the etiology of implant rupture. METHODS Analysis was based on Sientras prospective, open-label, U.S.-based clinical study of High-Strength Cohesive silicone breast implants. Patient and surgical characteristics were compared between ruptured and intact implants. RESULTS The subset of data used for this analysis included 1792 implants in 935 primary and revision augmentation patients implanted by 31 plastic surgeons, with an average follow-up of 6.6 years. The results confirm that rupture remains a rare adverse event. Overall, the rupture prevalence for this study was 2.4%. Rupture prevalence was lower among textured devices (0.8%) compared to smooth devices (3.8%). The prevalence of rupture was 7.8% among devices placed with a transaxillary incision site compared to 1.6% and 3.0% when placed with an inframammary or periareolar incision site, respectively. Rupture was reported in 5.5% of the devices that received steroid pocket irrigation, compared to 1.8% of the devices that did not. CONCLUSIONS Although ruptures in the Sientra study with the High-Strength Cohesive silicone gel implants were an uncommon occurrence, the authors were able to identify strong trends for the association of certain surgical factors and characteristics. The results show among other factors that an inframammary approach and a textured device were found to be protective against rupture. LEVEL OF EVIDENCE 2 Therapeutic.

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.

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