Adverse events associated with anastomotic coupling devices in microvascular reconstruction.

OBJECTIVE: In light of the recent US Food and Drug Administration (FDA) Class 2 safety recall notice for anastomotic coupling devices, it is important to understand related adverse events. The aim of this study was to characterize adverse events in anastomotic coupling devices for microvascular reconstruction. METHODS: A retrospective cross-sectional analysis using the 2011 to 2021 US FDA Manufacturer and User Facility Device Experience (MAUDE) database. All reports of adverse events involving anastomotic coupling devices were retrieved from the MAUDE database. Descriptive statistics were used to analyze categorized events. RESULTS: There were a total of 293 documented adverse events related to anastomotic coupling devices. These adverse events resulted in 91 (31.1 %) patient injuries and 239 (81.6 %) device malfunctions. The most frequent patient problems were thrombosis/hematoma (n = 38; 41.8 %), unspecified injury (n = 31; 34.1 %), and failure to anastomose (n = 13; 14.3 %). Free flap necrosis was reported in 42 % of thrombosis/hematoma cases (n = 16). The most common malfunctions were devices operating differently than expected (n = 74; 31.0 %), connection problems (n = 41; 17.2 %), and twisted/bent material (n = 19; 7.9 %). There was no significant trend in the number of adverse events over the study period (p > 0.05). CONCLUSIONS: Adverse events from anastomotic coupling devices represent an important and modifiable factor in free tissue failure. Adverse events are predominately related to devices operating differently than expected and may result in vascular compromise of the free flap. Reconstructive surgeons should be cognizant of defective anastomotic coupling devices and be prepared to utilize traditional hand-sewn anastomosis.

Intellectual Property in Facial Plastic and Reconstructive Surgery: The Importance and Process of Obtaining Intellectual Property Rights.

Understanding the purpose and process of obtaining intellectual property rights (IPR) is fundamental to health care innovation. Facial plastic and reconstructive surgeons are natural innovators; however, knowledge deficit in this space may hinder the ability to move ideas from the "bench to bedside." Here we provide an overview of IPR, outlining the steps necessary to obtain intellectual property protection in an academic setting while highlighting recent U.S. Food and Drug Administration (FDA) approvals pertaining to facial plastic and reconstructive surgery.

Management of Large Facial Defects.

There is considerable variation in the surgical management of patients with large facial defects after excision of skin malignancy. The surrounding facial subunits as well as local, regional, and distant soft-tissue flaps can be considered in more complicated facial defects. We place an emphasis on the versatility of adjacent tissue advancement and transposition flaps in the treatment of these defects. We also focus on the secondary reconstructive efforts necessary to achieve the best functional and aesthetic outcomes for patients.

Experience with pharmacologic leeching with bivalirudin for adjunct treatment of venous congestion of head and neck reconstructive flaps.

OBJECTIVES: The goal of this study was to review the feasibility of local bivalirudin injection for adjunct treatment of venous congestion of head and neck reconstructive flaps. METHODS: A retrospective chart review of patients who underwent bivalirudin treatment for venous congestion of head and neck reconstructive flaps in a single institution from September 1, 2012 to September 1, 2015 was undertaken. Individuals were treated with variable number of intradermal injections directly into the flap followed by a small skin incision to allow extended passive bleeding. The main outcome measure was improvement of flap congestion. RESULTS: Ten patients with free flap reconstruction (4 anterolateral thigh flaps, 2 pectoralis major flaps, 2 fibula osseocutaneous flaps, 1 supraclavicular flap, and 1 radial forearm free flap) of various head and neck defects underwent treatment with bivalirudin. Bivalirudin injections were utilized as adjunct therapy in 6 patients. Two individuals underwent alternate therapy for venous congestion immediately following injection and therefore the efficacy could not be assessed. Of the 8 remaining flaps, 4 developed partial necrosis, and 1 developed complete necrosis requiring additional reconstruction. Two individuals required blood transfusions during bivalirudin treatment. CONCLUSIONS: Bivalirudin is a safe and feasible adjunct therapy for treatment of flap congestion. It may serve as a useful alternative to traditional leech therapy, as bivalirudin negates the need for antibiotic prophylaxis, eliminates the psychological aversion associated with leech therapy, and avoids the potential for leech migration. Further work to determine the efficacy of bivalirudin to standard leech therapy is warranted.

Microvascular Flaps in Nasal Reconstruction.

Nasal reconstruction for subtotal and total rhinectomy defects is a challenging endeavor, which requires technical finesse, a keen artistic eye, and the ability to anticipate long-term changes that accompany postoperative healing. While local and regional flaps have traditionally been utilized to reconstitute missing nasal elements, certain situations may not provide sufficient or acceptable tissue for optimal reconstruction. In these situations, the three major components of the nose-lining, structural support, and external skin-may require reconstruction with tissues harvested from distant sites through microvascular free tissue transfer. Our objective in this article is to discuss the general approach to nasal reconstruction and present the considerations for free tissue transfer with regard to each nasal component. The virtues of free flap transfer as well as its shortcomings and potential complications are discussed.

Treatment of the periocular complex in paralytic lagophthalmos.

OBJECTIVES: Paralytic lagophthalmos can lead to devastating exposure keratitis. The main surgical intervention consists of upper eyelid loading. However, adjunctive lower eyelid and brow procedures are also available as necessary. We sought to analyze the use of periocular procedures in paralytic lagophthalmos at Johns Hopkins. METHODS: The method was a retrospective review of patients treated at a single tertiary care center from 2006 to 2012. RESULTS: One hundred one patients met inclusion criteria, and 20 patients were excluded for not meeting the minimum follow-up. Upper eyelid loading was required on 95/101 patients (95%). Adjunctive procedures were necessary in 73% (73/101) of patients. Lower eyelid procedures were used in 47% (47/101) and brow lifts in 47% (47/101). Older patients (>50 years) were more likely to require lower eyelid procedures (P=.04) and more likely to require revision (P=.003). Medial canthopexy and direct brow lift were associated with the need for revision (P=.006, P=.03). CONCLUSION: Paralytic lagophthalmos management is not one-size-fits-all. Upper eyelid loading is the mainstay of treatment; however, adjunctive procedures to the lower eyelid and brow are indicated in the majority of patients. Our retrospective review has allowed us to continue to refine our strategy for managing these patients.

Gracilis microneurovascular transfer for facial paralysis.

Facial nerve dysfunction occurs in varying degrees of severity due to several causes, and leads to asymmetric or absent facial movements. Regardless of the etiology, facial nerve dysfunction can be functionally and psychologically devastating. Many techniques to restore facial symmetry both at rest and with motion have been pursued throughout history. Within the past 30 years, free muscle microneurovascular transfer techniques have been developed to provide symmetric motion to the face. The aim of this article is to describe one of the most common and reliable techniques to restore midface mobility, namely, gracilis microneurovascular transfer.

Nasal Lining Reconstruction with Prelaminated Forehead Flap.

A successful nasal reconstruction relies heavily on a stable internal lining. Larger defects pose unique challenges for internal lining reconstruction as obtaining tissue of adequate size while maintaining airway patency is difficult. The prelamination technique uses a staged skin graft to the paramedian forehead flap prior to transfer. As such, a composite flap can be later transferred to reconstruct internal and external nasal defects concomitantly. This article reviews the current background, techniques, and clinical considerations in the use of the prelaminated forehead flap for nasal lining reconstruction in partial to total nasal defects.

Masseteric Atrophy Following Masseteric Nerve Transfer: Radiographic Findings of Asymmetry in the Paralyzed Face?

OBJECTIVES: To characterize the effect of facial reanimation using masseteric nerve transfer on the masseter muscle itself, examining whether there is any demonstrable atrophy postoperatively. METHODS: Electronic medical records of adult patients who underwent facial reanimation using masseteric nerve transfer at our institution over a 15-year period were reviewed. To account for the impact of postoperative radiation, randomly selected patients who underwent radical parotidectomy without nerve transfer and received postoperative radiation served as controls in a 1:1 fashion against those who underwent masseteric nerve transfer with postoperative radiation. RESULTS: Twenty patients were identified who underwent masseteric nerve transfer and had sufficient pre- and postoperative imaging to assess masseter volume (mean age 58.2, 60% female). Of the four patients who did not receive postoperative radiation, each demonstrated masseteric atrophy on the side of their nerve transfer, with a mean reduction in masseter volume of 20.6%. The remaining 16 patients were included in the case-control analysis accounting for radiation. When compared with controls, those in the study group were found to have a statistically significant difference in atrophy (p = 0.0047) and total volume loss (p = 0.0002). The overall reduction in masseter volume in the study group was significantly higher compared with the control group, at 41.7% and 16.6%, respectively (p = 0.0001). CONCLUSION: Facial reanimation utilizing masseteric nerve transfer appears to result in atrophy of the denervated masseter when compared with the contralateral muscle. This volume deficit may lead to further facial asymmetry for patients undergoing comprehensive reanimation surgery. LEVEL OF EVIDENCE: 3 Laryngoscope, 2024.

Longitudinal Analysis of the Use of Facial Reanimation Procedures for Bell's Palsy.

Background: Treatment of Bell's palsy ranges from medical management with high-dose corticosteroids to complex facial reanimation procedures. Objective: To characterize the number of static, dynamic, and combined facial reanimation procedures for the management of Bell's palsy using a national database over time. Methods: This retrospective cohort study included patients in the 2013-2020 National Surgical Quality Improvement Project database with a postoperative diagnosis of Bell's palsy. Cases were categorized as involving only static, only dynamic, and a combination of static and dynamic procedures. Chi-square or Fisher's exact tests were performed for patient demographics, and linear regressions were created to evaluate utilization trends. Results: In total, 294 patients were identified. There was no significant difference in patient sex and comorbidities between these treatment groups. Of the 294 patients, 101 received both types of procedures, 107 received only dynamic procedures, and 86 received only static procedures. The trendlines for all treatment groups were significantly positive (B = 1.27 for both, B = 0.89 for dynamic only, and B = 1.01 for static only). Conclusion: In this study of a national surgical database, an increase in static, dynamic, and combined treatments for patients with Bell's palsy was found.

Correcting for Rater Effects in Operating Room Surgical Skills Assessment.

OBJECTIVE: To estimate and adjust for rater effects in operating room surgical skills assessment performed using a structured rating scale for nasal septoplasty. METHODS: We analyzed survey responses from attending surgeons (raters) who supervised residents and fellows (trainees) performing nasal septoplasty in a prospective cohort study. We fit a structural equation model with the rubric item scores regressed on a latent component of skill and then fit a second model including the rating surgeon as a random effect to model a rater-effects-adjusted latent surgical skill. We validated this model against conventional measures including the level of expertise and post-graduation year (PGY) commensurate with the trainee's performance, the actual PGY of the trainee, and whether the surgical goals were achieved. RESULTS: Our dataset included 188 assessments by 7 raters and 41 trainees. The model with one latent construct for surgical skill and the rater as a random effect was the best. Rubric scores depended on how severe or lenient the rater was, sometimes almost as much as they depended on trainee skill. Rater-adjusted latent skill scores increased with attending-estimated skill levels and PGY of trainees, increased with the actual PGY, and appeared constant over different levels of achievement of surgical goals. CONCLUSION: Our work provides a method to obtain rater effect adjusted surgical skill assessments in the operating room using structured rating scales. Our method allows for the creation of standardized (i.e., rater-effects-adjusted) quantitative surgical skill benchmarks using national-level databases on trainee assessments. LEVEL OF EVIDENCE: N/A Laryngoscope, 2024.

Aesthetic analysis in rhinoplasty: surgeon vs. patient perspectives: a prospective, blinded study.

OBJECTIVE: To determine how patients seeking cosmetic rhinoplasty analyze themselves compared to their surgeon's analysis. Simply stated, "Does your surgeon view your nose the same as you?" STUDY DESIGN: Prospective, blinded study. METHODS: All primary rhinoplasty consultations completed a nasal analysis questionnaire. The patients' facial plastic surgeons completed an identical questionnaire. The results were compared and analyzed. RESULTS: Data underwent statistical analysis and subsequent factor analysis was performed. 132 patients participated in the study. Questions were grouped together based on factors: overall appearance, skin quality, tip dimensions, straightness, nostril show, and width. The only factor with reasonable surgeon/patient correlation was factor 1, overall appearance, with correlation 0.6473, p<0.001. CONCLUSIONS: Surgeons and patients are in agreement with the overall appearance of the nose, but differ in their analysis regarding the details. This information can be used to guide future discussions during consultations and most importantly help to better gauge and manage patient expectations.

The psychological and psychosocial effects of facial paralysis: A review.

Facial nerve function is essential for a multitude of processes in the face, including facial movement; expression; and functions, such as eating, smiling, and blinking. When facial nerve function is disrupted, facial paralysis may occur and various complications for the patient may result. Much research has been conducted on the physical diagnosis, management, and treatment of facial paralysis. However, there is a lack of knowledge of the psychological and social effects of the condition. Patients may be at an increased risk for anxiety and depression, as well as negative self and social perceptions. This review analyzes the current literature on the various adverse psychological and psychosocial effects of facial paralysis, factors that may play a role, and treatment options that may help improve patients' quality of life.

Management, Referral Patterns, and Outcomes in Bell's Palsy: A Single-Institution 903 Patient Series.

OBJECTIVE: In 2013, the American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS) published guidelines for Bell's palsy (BP), including recommendations for workup, management, and specialist referral. Patients with BP often present to primary care; however, adherence to guidelines may vary by setting. This study sought to evaluate the management of patients with BP presenting to primary care, emergency department (ED), and urgent care settings. STUDY DESIGN: Retrospective cohort study. SETTING: Tertiary care center. METHODS: Retrospective chart review of patients identified by diagnosis code for BP. RESULTS: A total of 903 patients were included; 687 (76.1%) presented to ED, 87 (9.6%) to internal medicine, 77 (8.5%) to family medicine, and 52 (5.8%) to urgent care. On presentation, 804 (89.0%) patients were prescribed corticosteroids and 592 (65.6%) antiviral therapy. Steroid therapy ranged from 1 dose to greater than a 14-day course, with 177 (19.6%) receiving an adequate duration of 10 days or greater. Referrals were provided to facial plastics and/or otolaryngology for 51 patients (5.6%). For all comers, 283 (31.3%) had complete resolution, 197 (21.8%) had an incomplete resolution, 62 (6.9%) had persistent palsy, and 361 (40.0%) lost to follow-up. In assessing the association between clinic setting and management, appropriate corticosteroid therapy (p < .01), imaging (p < .01), and eye care (p < .01) were statistically significant. CONCLUSION: Adherence to guidelines for BP management varies amongst providers. In our study cohort, 15.5% of patients received medical therapy in accordance with AAO-HNS guidelines, and only 5.6% were referred to facial plastics. To facilitate more appropriate care, tertiary care institutions may benefit from system-wide care pathways to manage acute BP.

Patient Perception of Education, Care Coordination, and Psychological Distress After Developing Facial Paralysis: A Qualitative Study.

Importance: The management of vestibular schwannoma may include observation, microsurgical resection, or radiation of a tumor near the facial nerve. Injury to the facial nerve can result in facial paralysis with major functional, social, and psychological sequelae, and the experiences of patients after paralysis are not well studied. Objective: To (1) identify patient preparedness for developing facial paralysis and how well their care is coordinated following its development and (2) present in their own words outcomes of facial paralysis in terms of physical health, emotional health, self-perception, and social interactions. Design, Setting, and Participants: A qualitative observational study was performed using semistructured interviews at a tertiary care academic medical center. Semistructured interviews were conducted between January 1, 2018, and June 30, 2019, with adults aged 25 to 70 years who developed facial paralysis after treatment for vestibular schwannoma. Data were analyzed from July 2019 to June 2020. Main Outcomes and Measures: Perceptions of the educational and emotional experiences of individuals who developed complete facial paralysis after surgical treatment of vestibular schwannoma. Results: Overall, 12 participants were interviewed (median age, 54 years [range, 25-70 years]; 11 were female). Saturation was achieved after 12 interviews, indicating that no further information could be elicited from additional interviews. Four major themes were identified: (1) lack of sufficient patient education about the diagnosis of facial paralysis; (2) lack of appropriate care coordination related to facial paralysis; (3) changes in physical and emotional health following facial paralysis; and (4) changes in social interactions and external support following facial paralysis. Conclusions and Relevance: It is well-known that patients with facial paralysis have reduced quality of life, severe psychological and emotional sequelae. However, little is currently done to help prepare patients for this undesirable outcome. In this qualitative study of facial paralysis, patients express, in their own words, their feeling that the education and management of facial paralysis by their clinicians was inadequate. Before patients undergo surgery, and certainly after injury to the facial nerve, clinicians should consider the patient's goals, preferences, and values to ensure that a comprehensive educational program and psychosocial support system are implemented. Facial reanimation research has not adequately captured these key patient factors associated with the quality of communication.

Clinical features, evaluation, and management of ophthalmic complications of facial paralysis: A review.

The purpose of this review was to study the evaluation, diagnosis, and management of ophthalmic complications associated with facial nerve palsy and to discuss the current and future interventions. The ophthalmic complications of facial paralysis include lagophthalmos, ectropion, exposure keratopathy, ocular synkinesis, and crocodile tears. Evaluation by an ophthalmologist skilled in recognizing and managing complications of facial paralysis shortly after its initial diagnosis can help identify and prevent long-term complications. Several types of grading scales are used to evaluate, measure the severity, and track surgical and patient-reported treatment outcomes. Lagophthalmos or ectropion are managed using temporary measures aimed at lubricating and covering the eye, including scleral lenses; however, these measures can be expensive and challenging to acquire and maintain. Temporary surgical interventions include lateral tarsorrhaphy, weighted eyelid implants, lateral canthoplasty, and other procedures that tighten or lift the eyelid or surrounding tissues. Management of flaccid facial paralysis due to iatrogenic injury or neoplasm requires neurorrhaphy or graft repair. The most common techniques for dynamic reconstruction in chronic facial paralysis are regional and free muscle flap transfer. Future directions for the management of ophthalmic complications aim to induce blinking and eye closure by developing systems that can detect blinking in the normal eye and transmit the signal to the paralyzed eye using mechanisms that would stimulate the muscles to induce eyelid closure. Blink detection technology has been developed, and a study demonstrated that blinking can be stimulated using electrodes on the zygomatic branch of the facial nerve. Further studies are needed to develop a system that will automate blinking and synchronize it with that of the normal eye.

Clinical application of physical therapy in facial paralysis treatment: A review.

This review aims to summarize recent studies regarding the specific modalities of physical therapy as a form of treatment for patients with facial paralysis, analyze the different components of physical therapy, and provide healthcare providers with guidance for their best practice in treating patients with facial paralysis. This paper will discuss the mechanism, indications, and impact factors for facial retraining, evaluate the standards for facial retraining, the creation of a treatment plan, and analyze the combined use of facial retraining with botulinum toxin injections and the application of facial retraining in post facial reanimation patients. Other modes of physical therapy, including electrical stimulation, dry needling, and acupuncture, will be addressed. Lastly, the application of new digital technology will be discussed.

Variations in Payer-Negotiated Prices for Head and Neck Reconstructive Surgery.

OBJECTIVE: Little is known about pricing for reconstructive procedures of the head and neck. As of January 2021, the Centers for Medicare and Medicaid Services requires hospitals to disclose payer-negotiated prices for services, offering new insight into prices for privately insured patients. STUDY DESIGN: Cross-sectional analysis. SETTING: Turquoise database. METHODS: Payer-negotiated facility fees for 41 reconstructive surgeries were grouped by procedure type: primary closure, skin grafts, tissue rearrangement, locoregional flaps, or free flaps. Prices were normalized to account for local labor costs, then calculated as percent markup in excess of Medicare reimbursement. The mean percent markup between procedure groups was compared by the Kruskal-Wallis test. Subset analyses were performed to compare mean percent markup using a Student's t test. We also assessed price variation by calculating the ratio of 90th/10th percentile mean prices both across and within hospitals. RESULTS: In total, 1324 hospitals (85% urban, 81% nonprofit, 49% teaching) were included. Median payer-negotiated fees showed an increasing trend with more complex procedures, ranging from $379.54 (interquartile range [IQR], $230.87-$656.96) for Current Procedural Terminology (CPT) code 12001 ("simple repair of superficial wounds ≤2.5 cm") to $5422.60 ($3983.55-$8169.41) for CPT code 20969 ("free osteocutaneous flap with microvascular anastomosis"). Median percent markup was highest for primary closure procedures (576.17% [IQR, 326.28%-1089.34%]) and lowest for free flaps (99.56% [37.86%-194.02%]). Higher mean percent markups were observed for rural, for-profit, non-Northeast, nonteaching, and smaller hospitals. CONCLUSION: Wide variation in private payer-negotiated facility fees exists for head/neck reconstruction surgeries. Further research is necessary to better understand how pricing variation may correlate with out-of-pocket costs and quality of care.

Endoscopic forehead lift in patients with male pattern baldness.

PURPOSE: The presence of male pattern baldness poses a significant challenge when attempting to optimize treatment of the upper third of the face. The purpose of this study is to demonstrate and discuss results of the endoscopic forehead lift in patients with male pattern baldness. MATERIALS AND METHODS: This was a retrospective case series done in an academic medical center. Eleven patients with male pattern baldness (Norwood class IV-VII) underwent endoscopic forehead lift for forehead creases and brow ptosis. RESULTS: All patients achieved smoothing of the forehead and elevation of the brow with no scalp anesthesia at 1 month postoperatively. All patients were pleased with the healing of their incisions in midline, paramedian, and temporal regions. Alloplastic fixation devices used were visible postoperatively in 2 patients initially. CONCLUSIONS: The endoscopic forehead lift is a suitable approach for treating the upper third of the face in the presence of male pattern baldness. The use of alloplastic fixation devices may be used in this patient population, but other fixation methods should be considered.

Tri-Vector Gracilis Microneurovascular Free Tissue Transfer with Periocular Component to Achieve a Duchenne Smile in Patients with Facial Paralysis.

Importance: Traditional techniques of facial reanimation using gracilis free tissue transfer do not address the lower eyelid or provide contraction at the site of orbicularis oculi, which is necessary to create a natural appearing Duchenne smile. In this report, we describe a novel technique to achieve this element of a true mimetic smile using a tri-vector gracilis muscle flap. Objective: To describe a novel gracilis free flap technique for facial reanimation to provide contraction of the inferior and lateral orbicularis oculi and achieve a Duchenne smile. Design, Setting, and Participants: This was a surgical pearls-description of a novel surgical technique at Academic Tertiary Medical Center. Three patients underwent the operation.