Faculty Bibliography

Background: Transcatheter mitral valve repair with the MitraClip system has been shown to be safe and effective for the treatment of significant primary mitral regurgitation (MR) in patients deemed prohibitive risk for surgery. This analysis evaluated the outcomes of MitraClip repair in primary MR subjects with STS PROM (Society of Thoracic Surgeons Predicted Risk of Mortality) score <6% for surgical repair and <8% for replacement from the global EXPAND (A Contemporary, Prospective Study Evaluating Real-World Experience of Performance and Safety for the Next Generation of MitraClip Devices) study.
Method(s): EXPAND is a prospective, multicenter, international, single-arm study that enrolled subjects at 57 centers in Europe and the United States. All echocardiograms were analyzed by an independent echo core laboratory, and major adverse events were adjudicated by an independent clinical events committee. Study outcomes included MR severity, procedural outcomes, major adverse events, New York Heart Association functional class and KCCQ (Kansas City Cardiomyopathy Questionnaire) score.
Result(s): Four hundred and twenty subjects with primary MR had adequate baseline echocardiographic imaging for assessment by the echo core laboratory. Of the 420 subjects, at least 166 patients either had an STS repair score <6% and an STS replacement score <8%. Average age was 77.2 +/- 10.4 years old, and 54% of the subjects were men. STS PROM score for surgical repair was 2.9 +/- 1.3% and replacement was 4.6 +/- 1.8%. Echo core laboratory-adjudicated acute procedural success, defined as survival to discharge with a successful implant resulting in reduction to MR severity <=2+, was achieved in 93.4% of the subjects. Clinical events committee-adjudicated all-cause mortality rate at 30 days was 1.2% (n = 2), and major adverse events rate was 4.2% (n = 7). MR reduction to <=2+ and MR <=1+ were achieved in 98% and 89% of subjects at 30 days, respectively. The reduction in MR severity was also associated with a significant reduction in left ventricle end-diastolic dimension (52.9 +/- 6.8 mm to 49.9 +/- 7.2 mm; n = 144; p < 0.0001) and volume (126.1 +/- 50.5 ml to 114.5 +/- 44.9 ml; n = 138; p < 0.0001). There were also improvements in functional capacity (69% New York Heart Association functional class III/IV at baseline vs. 18% at 30 days; p < 0.0001) and quality of life (mean change in KCCQ score from baseline to 30 days: +18.7 +/- 24.0; p < 0.0001). Univariate analysis of MR reduction (2 grades or more) were baseline MR severity (p < 0.0001), peak E velocity (p < 0.037), mean mitral gradient (p < 0.026), presence of ruptured chordae (p < 0.001), leaflet flail (p < 0.0002), leaflet billowing (p < 0.0001), and prolapse or flail gap (p < 0.037).
Conclusion(s): In patients with primary MR and an STS repair risk score <6% and replacement score <8%, the MitraClip NTR and XTR system was found to be safe and effective at reducing MR and improving left ventricular remodeling and was associated with significant improvements in quality of life and functional capacity. Categories: STRUCTURAL: Valvular Disease: Mitral
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BACKGROUND:Two procedures that have demonstrated collagen-stimulating properties and improvements in skin laxity in a variety of aesthetic indications are microfocused ultrasound with visualization (MFU-V) and injection with calcium hydroxylapatite (CaHA). OBJECTIVES/OBJECTIVE:By treating skin laxity with a combination of these therapies, it was hypothesized that our patients would experience improved appearance and quality of life as measured by the BODY-Q. METHODS:A total of 60 consecutive female patients aged 30-60 years with BMI less than 28 kg/m2 who expressed interest in treatment for skin laxity affecting the outer thighs completed select scales from the BODY-Q within 1 week of treatment. At the time of treatment, MFU-V was directed to the outer thighs (150 lines at focal depths of 3.0 and 4.5 mm per outer thigh). Immediately following MFU-V, patients received treatment with CaHA injected into the subdermis (1.5 mL diluted 1:1 with 1.5 mL of 2% lidocaine solution per outer thigh). At 90 days posttreatment, these patients repeated the BODY-Q. RESULTS:At 90 days posttreatment, with 100% follow-up among the 60 consecutive female patients treated, scores from select scales of the BODY-Q showed statistically significant improvement (Body Image, p<0.01; Appraisal of Excess Skin, p<0.01; Satisfaction with Hips and Outer Thighs, p<0.01; Appearance-Related Psychosocial Distress, p<0.01). CONCLUSIONS:Following treatment of skin laxity on the outer thighs with a combination of MFU-V and CaHA, our patients reported a statistically significant improvement in appearance and quality of life at 90 days posttreatment. This may be applicable to other areas of the body.

INTRODUCTION/UNASSIGNED:Nasal duplication is a rare congenital deformity with many subtypes including supernumerary nostril. The challenge of surgical correction is to achieve nasal symmetry and restore nasal airflow. However, there is no defined protocol for treatment, especially with regard to presurgical therapy. METHODS/UNASSIGNED:We performed a review of literature of studies reporting on patients with supernumerary nostril to complete this review. We then report on a patient with supernumerary nostril who was treated with nostril expansion therapy prior to surgical intervention. RESULTS/UNASSIGNED:We identified 59 cases of nostril duplication. Because of the rarity of the condition, treatment protocols varied greatly. For our patient, preoperative nasal appliance therapy was implemented for 3 months prior to surgical intervention. Patient was followed-up regularly for 1 year. DISCUSSION/UNASSIGNED:Although literature on nasal duplication is scarce, there is a general agreement that early intervention has psychological, anatomic, and functional benefits to the patient. In our case report, nostril expansion therapy was easy to implement and facilitated surgical reconstruction, resulting in aesthetic outcome and expanded airway 1 year postoperatively.

We examine ethical considerations in access to facial transplantation (FT), with implications for promoting health equity. As a form of vascularised composite allotransplantation, FT is still considered innovative with a relatively low volume of procedures performed to date by a small number of active FT programmes worldwide. However, as numbers continue to increase and institutions look to establish new FT programmes, we anticipate that attention will shift from feasibility towards ensuring the benefits of FT are equitably available to those in need. This manuscript assesses barriers to care and their ethical implications across a number of considerations, with the intent of mapping various factors relating to health equity and fair access to FT. Evidence is drawn from an evolving clinical experience as well as published scholarship addressing several dimensions of access to FT. We also explore novel concerns that have yet to be mentioned in the literature.

Oral cancer patients often have severe, chronic, and mechanically induced pain at the site of the primary cancer. Oral cancer pain is initiated and maintained in the cancer microenvironment and attributed to release of mediators that sensitize primary sensory nerves. This study was designed to investigate the histopathology associated with painful oral cancers in a preclinical model. The relationship of pain scores with pathologic variables was also investigated in a cohort of 72 oral cancer patients. Wild-type mice were exposed to the carcinogen, 4-nitroquinoline 1-oxide (4NQO). Nociceptive (pain) behavior was measured with the dolognawmeter, an operant device and assay for measuring functional and mechanical allodynia. Lesions developed on the tongues and esophagi of the 4NQO-treated animals and included hyperkeratoses, papillomas, dysplasias, and cancers. Papillomas included lesions with benign and dysplastic pathological features. Two histologic subtypes of squamous cell carcinomas (SCCs) were identified-SCCs with exophytic and invasive components associated with papillary lesions (pSCCs) and invasive SCCs without exophytic histology (iSCCs). Only the pSCC subtype of tongue cancer was associated with nociceptive behavior. Increased tumor size was associated with greater nociceptive behavior in the mouse model and more pain experienced by oral cancer patients. In addition, depth of invasion was associated with patient-reported pain. The pSCC histology identifies 4NQO-induced tongue cancers that are expected to be enriched for expression and release of nociceptive mediators.

BACKGROUND:Spring-assisted surgery (SAS) is an accepted alternative to cranial vault remodeling (CVR) for treatment of sagittal craniosynostosis. The long-term safety and efficacy profiles of SAS have not been established. METHODS:This study is a retrospective exam of all patients treated with SAS (n=175) or CVR (n=50) for sagittal craniosynostosis at our institution from 2003-2017. Data collected includes demographic and operative parameters, pre- and post-operative cephalic indices, and complications. Whitaker grades were assigned blindly by a craniofacial surgeon not involved in patients' care. RESULTS:The mean age at surgery was significantly lower for the SAS compared with CVR group (4.6 vs 22.2 months, p<0.001). Even when combining spring placement with spring removal operations, total surgical time (71.1 vs 173.5 min), blood loss (25.0 vs 111.2 mL) and hospital stays (41.5 vs 90.0 hrs.) were significantly lower for the SAS cohort vs the CVR group (p<0.001 for all). There were no differences in infection, re-operation rate, or headaches between the groups. The percent improvement in cephalic index (CI) was not significantly different at 1- (p=0.13), 2- (p=0.99), and 6- (p=0.86) years post-operatively. At 12 years post-operatively the SAS group had persistently improved CI (75.7 vs 70.7 pre-op). Those receiving SAS had significantly better Whitaker scores indicating lesser need for revisionary surgery, compared with the CVR group (p=0.006). CONCLUSIONS:Compared with our CVR technique, SAS requires less OR time with less blood loss, but has equivalent long term cephalic indices and subjectively better shape outcomes.

BACKGROUND:Controversy exists regarding the optimal surgical approach for non-syndromic sagittal synostosis. This study provides the first comparative analysis of the long-term behavioral, psychological, and executive function outcomes for patients who underwent either cranial vault remodeling (CVR) or spring-assisted strip craniectomy (SAS). METHODS:Thirty-six CVR patients and 39 SAS patients were evaluated. Parents and caregivers completed the Behavior Rating Inventory of Executive Function (BRIEF) and the Behavior Assessment System for Children, Second Edition (BASC-2) to evaluate behavioral, emotional, social, adaptive, and executive functioning skills. RESULTS:There were no statistically significant differences between the CVR and the SAS groups (P > 0.05) in any of the BRIEF areas of function. Furthermore, the BASC-2 battery illustrated no significant differences in all areas analyzed except one. Among the 2 groups, the CVR group was rated as having fewer social withdrawal symptoms on the BASC-2 (47.00 ± 10.27) compared to the SAS cohort (54.64 ± 10.96), F = 6.79, P = 0.012, Cohen d = 0.688. However, both means were still within the normal range. CONCLUSIONS:Children undergoing SAS and CVR procedures for isolated sagittal synostosis were not rated as having clinically significant behavioral, emotional, social, adaptive, or executive functioning problems on parental forms.

BACKGROUND:Virtual surgical planning has contributed to technical advancements in free fibula flap mandible reconstruction. The authors present the largest comparative study on the latest modification of this technology: the use of patient-specific, preoperatively customized reconstruction plates for fixation. METHODS:A retrospective chart review was performed on all patients undergoing mandibular reconstruction with virtually planned free fibula flaps at a single institution between 2008 and 2018. Patient demographics, perioperative characteristics, and postoperative outcomes were reviewed. Reconstructions using traditional fixation methods were compared to those using prefabricated, patient-specific reconstruction plates. RESULTS:A total of 126 patients (mean age, 48.5 ± 20.3 years; 61.1 percent male) underwent mandibular reconstruction with a free fibula flap. Mean follow-up time was 23.5 months. A customized plate was used in 43.7 percent of cases. Reconstructions with patient-specific plates had significantly shorter total operative times compared with noncustomized fixation methods (643.0 minutes versus 741.7 minutes; p = 0.001). Hardware complications occurred in 11.1 percent of patients, with a trend toward a lower rate in the customized plate group (5.5 percent versus 15.5 percent; p = 0.091). Multivariate regression showed that the use of customized plates was a significant independent predictor of fewer overall complications (p = 0.03), shorter operative time (p = 0.014), and shorter length of stay (p = 0.001). CONCLUSIONS:Compared to traditional fixation methods, patient-specific plates are associated with fewer complications, shorter operative times, and reduced length of stay. The use of customized reconstruction plates increases efficiency and represents the latest technological innovation in mandibular reconstruction. CLINICAL QUESTION/LEVEL OF EVIDENCE:Therapeutic, III.