Clinical Outcome of Nerve Decompression Surgery for Migraine Improves with Nerve Wrap.

BACKGROUND: Chronic migraine headaches affect nearly 30 million Americans every year and are responsible for roughly 1.2 million emergency department visits annually. Many of the standard therapies commonly used to treat migraines are often unsuccessful and may furthermore introduce unwanted side effects. The purpose of this study was to identify independent predictors of clinical improvement in patients undergoing surgical nerve decompression for migraine. METHODS: A retrospective chart review between 2010 and 2020 was conducted. The primary endpoint was clinical improvement at 1-year follow-up, defined as an independence from prescription medications. Patients were stratified into two groups: clinical improvement and treatment failure. Backward multivariable logistic regression was used to examine the associations between migraine improvement and different patient characteristics. RESULTS: A total of 153 patients were included. In total, 129 (84.3%) patients improved and 24 (15.7%) did not. Significant associations with clinical improvement at multivariable logistic regression were found with acellular dermal matrix nerve wrap (OR = 10.80, 95%CI: 6.18-16.27), and operation of trigger sites four (OR = 37.96, 95%CI: 2.16-73.10) and five (OR = 159, 95%CI: 10-299). CONCLUSION: The use of acellular dermal matrix nerve wraps in surgery was significantly associated with clinical migraine improvement, as was operation at trigger sites four and five.

Porcine Acellular Peritoneal Matrix in Immediate Breast Reconstruction: A Multicenter, Prospective, Single-Arm Trial.

BACKGROUND: Use of biological implants such as acellular dermal matrices in tissue expander breast reconstruction is a common adjunct to submuscular implant placement. There is a paucity of published prospective studies involving acellular matrices. The authors sought to evaluate a porcine-derived acellular peritoneal matrix product for immediate breast reconstruction. METHODS: A prospective, single-arm trial was designed to analyze safety and outcomes of immediate tissue expander-based breast reconstruction with a novel porcine-derived acellular peritoneal matrix surgical mesh implant. Twenty-five patients were enrolled in this industry-sponsored trial. Patient demographics, surgical information, complications, histologic characteristics, and satisfaction (assessed by means of the BREAST-Q questionnaire) were evaluated. RESULTS: Twenty-five patients (44 breasts) underwent mastectomy with immediate breast reconstruction using tissue expanders with acellular peritoneal matrix. Sixteen reconstructed breasts experienced at least one complication (36 percent). Seroma and hematoma occurred in one of 44 (2.3 percent) and two of 44 breasts (4.6 percent), respectively. Wound dehiscence occurred in four of 44 breasts (9.1 percent). Three subjects experienced reconstruction failure resulting in expander and/or acellular peritoneal matrix removal (6.8 percent); all failures were preceded by wound dehiscence. Histologic analysis showed cellular infiltration and product resorption. Results of the BREAST-Q demonstrated a level of postoperative patient satisfaction consistent with results in the available literature. CONCLUSIONS: Prepared porcine-derived acellular peritoneal matrix is a safe adjunct in immediate two-stage tissue expander-based breast reconstruction. Further studies are required to determine efficacy compared to current commercially available acellular matrices. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, IV.

Ten-year Core Study Data for Sientra's Food and Drug Administration-Approved Round and Shaped Breast Implants with Cohesive Silicone Gel.

BACKGROUND: In March 2012, the United States Food and Drug Administration approved Sientra's application for premarket approval of its portfolio of round and shaped silicone gel breast implants based on data from the largest silicone gel breast implant study to date. This article presents the results of Sientra's Core Study at the conclusion of 10 years. METHODS: The Sientra Core Study was a 10-year, open-label, prospective, multicenter clinical study designed to assess the safety and effectiveness of Sientra's breast implants in augmentation and reconstruction. A total of 1,788 patients (3,506 implants) were enrolled, including 1,116 primary augmentation, 363 revision-augmentation, 225 primary reconstruction, and 84 revision-reconstruction. RESULTS: Across all cohorts, the rate of rupture by patient was 8.6%, the rate of Baker grade III/IV capsular contracture was 13.5%, and the rate of reoperation was 31.5%. The rate of capsular contracture was statistically significantly lower for textured devices [9.0%; 95% confidence interval (CI), 7.0-11.5%] compared with smooth devices (17.5%; 95% CI, 14.9-20.4%). There were no cases of breast implant-associated anaplastic large cell lymphoma. Primary reasons for reoperations included capsular contracture (18.8%), and style/size change (19.3%), with over 50% of the reoperations due to cosmetic reasons. CONCLUSION: The 10-year results of Sientra's Core Study support a comprehensive safety and effectiveness profile of Sientra's portfolio of round and shaped breast implants.

International teleconsultation on conjoined twins leading to a successful separation: a case report.

Conjoined twins are identical twins that have incompletely separated in utero. The prognosis for conjoined twins is poor and management in a skilled tertiary care centre is paramount for definitive care. We describe our experience with a telemedical consultation on conjoined twins in The Dominican Republic from our eHealth centre in Valhalla, NY. The patients were two month old, female, pygopagus conjoined twins. A multidisciplinary teleconference was initiated with the patients, their family, the referring paediatrician and our team. Based on this teleconsultation, the team felt as though the twins may be amenable to a surgical separation. They presented to our centre in Valhalla, NY, for a detailed physical examination and series of imaging studies. Soon after, the patients underwent a successful 21 h separation procedure and were discharged 12 weeks later. To our knowledge, this is one of the first reports of an international teleconsultation leading to a successful conjoined twin separation procedure.

Calcium Hydroxylapatite Dermal Filler for Treatment of Dorsal Hand Volume Loss: Results From a 12-Month, Multicenter, Randomized, Blinded Trial.

BACKGROUND: Calcium hydroxylapatite (CaHA) microspheres suspended in a carrier gel is an opaque dermal filler that has been used to provide immediate volume correction in the dorsal hands. OBJECTIVE: To assess the safety and effectiveness of CaHA for the correction of volume loss in the hands up to 12 months. MATERIALS AND METHODS: This multicenter, controlled, single-blind study (NCT01832090) included 114 subjects randomized 3:1 to CaHA treatment and untreated control groups. Effectiveness was assessed by blinded investigators using the validated Merz Hand Grading Scale (MHGS). Subject-reported improvement was assessed using the Global Aesthetic Improvement Scale. Effects of treatment on hand function were also assessed. RESULTS: A total of 75% of subjects achieved ≥1-point improvement on the MHGS (p < .0001) at 3 months (primary end point); this response was generally maintained through 12 months. Proportions of subjects reporting improvement ranged from 98% (3 months) to 86% (12 months). There were no clinically significant differences between control and CaHA-treated subjects in any hand function measure. Adverse events were generally expected, minor, short-lived, injection-related, and similar to those observed in previous CaHA clinical studies. CONCLUSION: Treatment with CaHA results in significant improvement in the appearance of the dorsal hand and is well tolerated.

An Algorithmic Approach to Operative Management of Complex Pediatric Dog Bites: 3-Year Review of a Level I Regional Referral Pediatric Trauma Hospital.

BACKGROUND: Incidence of dog bites continues to rise among the pediatric population and serves as a public health threat for the well-being of children. Plastic surgeons are at the forefront of initial management and eventual outcome of these devastating injuries. This study set out to determine the nature of dog bite injuries treated over a 3-year period at a large level 1 pediatric trauma center. METHODS: A retrospective review of emergency room records of all pediatric patients (age, 0-18 years old) who sustained dog bites between January 2012 and December 2014 were gathered. All details about age of patient, location and severity of dog bites, type of dog breed, antibiotics given, and emergency versus operative treatment were recorded and analyzed. RESULTS: One hundred eight patients aged 5 months to 18 years old were treated in the emergency department after suffering dog bite injuries during the study period. The highest incidence of dog bites occurred in preschool children. The mean age for patients who required operative repair was lower than the mean age for patients who underwent primary closure in the emergency department. The location of injury was most commonly isolated to the head/neck region. Of the 56 cases that had an identified dog breed, pit bulls accounted for 48.2% of the dog bites, and 47.8% of pit bull bites required intervention in the operating room. CONCLUSION: Children with large dog bite injuries require more immediate care in a level 1 pediatric trauma hospitals in order to optimize their hospitalization course and eventual outcome.

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 Sientra's (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 Sientra's 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.

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

UNLABELLED: 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-cm 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.

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 Sientra's premarket approval application for its portfolio of silicone gel breast implants based on their review of Sientra's 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 Sientra's portfolio of round and shaped implants through 8 years. LEVEL OF EVIDENCE: 3 Therapeutic.

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 Sientra's 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.

BACKGROUND: Prosthetic 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. METHODS: The 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. RESULTS: Preliminary 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. CONCLUSIONS: Preliminary 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.

Outpatient management of flexor tenosynovitis: use of On-Q system to deliver constant antibiotic irrigation and pain control improves rehabilitation.

BACKGROUND: Flexor tenosynovitis accounts for nearly 10% of all hand infections and, if untreated, can have devastating consequences. Late presentation often requires operative intervention that requires open drainage and irrigation of the flexor tendon sheath with prolonged rehabilitation. OBJECTIVE: We report the use of closed-catheter irrigation system with the On-Q delivery system that allows for simultaneous in situ antibiotic and pain control for outpatient treatment of flexor tenosynovitis. METHODS: The On-Q delivery system was placed in 6 consecutive patients who met the criteria of all 4 Knavel signs. They all underwent open drainage and closed irrigation system with 0.25% bupivacaine and 250 mg cefazolin over a 1-week period. RESULTS: In all 6 patients, there was no use of narcotic analgesics or oral antibiotics upon discharge. Postoperative hand therapy and range of motion was initiated on postoperative day 1. There was satisfactory progression of range of motion and hand therapy. CONCLUSIONS: This initial clinical case series supports the use of the closed irrigation delivery system with in situ antibiotic and analgesic delivery for more rapid rehabilitation of patients with flexor tenosynovitis.

Five-year follow-up data from the U.S. clinical trial for Sientra's U.S. Food and Drug Administration-approved Silimed® brand round and shaped implants with high-strength silicone gel.

BACKGROUND: In March of 2012, the U.S. Food and Drug Administration approved Sientra's application for premarket approval for its Silimed brand silicone gel implants, based on data from the largest silicone gel breast implant study to date. This was the first approval for shaped silicone gel breast implants. This article presents the results of Sientra's study through 5 years. METHODS: Sientra's study is an ongoing, 10-year, open-label, prospective, multicenter clinical study designed to assess the safety and effectiveness of Sientra's implants in patients undergoing augmentation and reconstruction. A total of 1788 subjects were implanted with 3506 implants, including 1116 primary augmentation, 363 revision-augmentation, 225 primary reconstruction, and 84 revision-reconstruction subjects. Physical evaluations and complications were recorded at each visit. Effectiveness was measured by postimplantation bra cup size and assessment of subject satisfaction and quality of life. Of the 1788 subjects, 571 underwent magnetic resonance imaging to assess silent rupture. Safety endpoints were analyzed using the Kaplan-Meier method. RESULTS: Across all cohorts, the risk of rupture was 1.8 percent (95 percent CI, 1.2 to 2.6 percent), the risk of capsular contracture (Baker grade III/IV) was 9.0 percent (95 percent CI, 7.6 to 10.6 percent), and the risk of reoperation was 23.8 percent (95 percent CI, 21.8 to 26.0 percent). Over 99 percent of surgeons reported satisfaction with the postoperative results, and subject satisfaction remained high 5 years after implantation. CONCLUSION: The 5-year results of Sientra's study continue to provide a comprehensive safety and effectiveness profile of Sientra's portfolio of Silimed brand shaped and round implants. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, IV.

Complications from international surgery tourism.

Medical tourism is an increasing trend, particularly in cosmetic surgery. Complications resulting from these procedures can be quite disruptive to the healthcare industry in the United States since patients often seek treatment and have no compensation recourse from insurance. Despite the increasing number of plastic surgery patients seeking procedures abroad, there have been little reported data concerning outcomes, follow-up, or complication rates. Through a survey of American Society of Plastic Surgeons (ASPS) members, the authors provide data on trends to help define the scope of the problem.

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.

Subperiosteal rejuvenation of the forehead.

Subperiosteal rejuvenation of the forehead may be performed through several small incisions in the brow. Small incisions are placed in the hairline and within the hair-bearing portion of the brow. The procedure provides a safe and reliable way to improve the position of the brow. The addition of resorbable screw fixation improves the stability of the brow position postoperatively and facilitates healing in the desired location. Subperiosteal brow lift may be performed successfully by way of minimally invasive incisions with favorable results.