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Biomedical subjects

Steven R Cohen

Publications and source records attributed to Steven R Cohen.

At least 19 recordsLinked to original sources

Emotional and psychological impact of delayed craniosynostosis repair.

INTRODUCTION: Among children with craniosynostosis, there exists an interesting dynamic involving parents' preconceptions of craniosynostosis and its repair, influenced in large part by differing cultural perspectives. In a time in which we are understanding how critical a child's early formative years are in influencing his/her emotional and psychological development, the authors describe one medical aspect involved in that dynamic process. MATERIALS AND METHODS: The authors reviewed their cumulative experience at the Children's Hospital San Diego between January 2000 and June 2004 and identified nine children with significant craniofacial deformities and, for one reason or another, had delayed surgical repair. DISCUSSION: The authors have found that by age 6, parents will often bring their children back to their physician and insist on surgical correction. The significant motivating factor in most of these cases stems from teasing by classmates with respect to head shape. In this manuscript, we report and discuss some of the emotional and psychological issues associated with delayed craniosynostosis repair. Often times, these issues are overlooked or underemphasized in the overall surgical care of such patients.

Adaptation, Psychological↗

Diltiazem induces severe photodistributed hyperpigmentation: case series, histoimmunopathology, management, and review of the literature.

BACKGROUND: Diltiazem hydrochloride is a commonly prescribed benzothiazepine calcium channel blocker for the treatment of cardiovascular disease. Recently, 8 cases of diltiazem-induced photodistributed hyperpigmentation occurring predominantly in elderly African American women were reported. Here, we report occurrence for the first time in a light-skinned African American woman and a Hispanic woman. We also report this finding in an African American man. Biopsy specimens of hyperpigmented areas were obtained for histopathologic evaluation and marker studies. Photospectrometry analysis for diltiazem was performed to analyze the photoabsorption properties of this drug. OBSERVATIONS: Routine laboratory examination results were normal in all patients. Serologic test results for antinuclear antibodies, including Sjögren antibodies anti-Ro (SS-A) and anti-La (SS-B), were negative. Histopathologic analysis of the skin biopsy specimens revealed a sparse lichenoid infiltrate, prominent pigmentary incontinence, and numerous melanophages in the dermis. There was no increase in dermal mucin suggestive of lupus. The mononuclear cells in the specimens were strongly positive for CD3, weakly positive for CD68, and either weakly positive or negative for CD79a. All specimens were negative for Alcian blue staining. Photospectrometry analysis of diltiazem showed an absorption range within the UV-B spectrum. CONCLUSIONS: Photospectrometry analysis revealed diltiazem could demonstrate a photosensitizing effect within the UV-B range. Discontinuation of therapy with diltiazem is the most effective modality in resolving hyperpigmentation. Avoidance of sun exposure and consistent use of sunscreens and sun-protective clothing are indicated for patients undergoing diltiazem therapy.

Aged↗

ArteFill: a long-lasting injectable wrinkle filler material--summary of the U.S. Food and Drug Administration trials and a progress report on 4- to 5-year outcomes.

ArteFill, the successor product to Artecoll, is an injectable wrinkle filler composed of polymethylmethacrylate microspheres and bovine collagen, which offers long-lasting and probably permanent augmentation of wrinkles and skin contour deformities. The pivotal U.S. Food and Drug Administration study consisted of 251 subjects at eight centers in the United States who received injections of ArteFill or bovine collagen dermal filler (control) in 1334 wrinkles of the glabella, nasolabial folds, radial upper lip lines, and corners of the mouth. The efficacy data generated by masked observers using a photographic Facial Fold Assessment Scale demonstrated a significant improvement with ArteFill compared with collagen at 6 months (p < 0.001) in the nasolabial folds. In the ArteFill group, 12-month follow-up was obtained for 111 subjects (86.7 percent) and showed persistence of significant wrinkle correction. A subgroup of 69 patients who received ArteFill were recalled 4 to 5 years later. Five patients reported six late adverse events that occurred from 2 to 5 years after the initial injection; four of the adverse events were mild cases of lumpiness and two were severe. The total number of late adverse events was six of 272 (2.2 percent) wrinkles injected. Among the 272 wrinkles evaluated at 5 years, two events (0.7 percent) in one patient were rated as severe (a nodular, minimally inflammatory to noninflammatory reaction in both nasolabial folds). Investigator Facial Fold Assessment ratings at 4 to 5 years were improved from baseline by 1.67 points (p < 0.001).

Adult↗

An overview of permanent and semipermanent fillers.

The demand for safe, effective, long-lasting, biocompatible dermal filler materials is increasing. Many products that include synthetic polymers and autologous tissue have emerged that attempt to meet these criteria. An overview of injectable permanent fillers, including ArteFill, Aquamid, and silicone, and semipermanent fillers, including Radiesse, Sculptra, and autologous fat, is presented. A discussion of their composition, histologic characteristics, antigenicity, U.S. Food and Drug Administration approval status, indications for use, efficacy, injection technique, and adverse effects is provided.

Acrylic Resins↗

Clinical experience with a new fast-resorbing polymer for bone stabilization in craniofacial surgery.

Polylactic acid (PLA) and polyglycolic acid have been successfully used as suture material during the past 30 years and have been successfully used in various orthopedic and craniofacial applications, with increasing frequency during the past 15 years. To eliminate some of the problems seen with the longer-lasting Macropore PLA product and other longer-lasting resorbable systems, a new fast-resorbing polymer (FRP) was manufactured by Macropore-Medtronic Neurologic Technologies, Inc. from commercially available 85:15 poly(D,L-lactide-co-glycolide) raw material using traditional melt-processing techniques. The delivery system is easily used and uses essentially the same instrumentation. One hundred and sixty eight patients who had implantation of the FRP were studied. Detailed clinical evaluation was completed after surgery and at each postoperative visit. Overall, there was a 2.1% implant-related complication rate, which compared favorably to the 8.5% implant-related complication rate associated with the longer-lasting PLA product. All patients who received FRP implants have had maintenance of stable bony fixation, followed by bony healing and satisfactory or excellent cosmetic results. The results from the FRP study indicate that the FRP material and implants are safe and effective in craniomaxillofacial applications.

Absorbable Implants↗

ArteFill: a permanent skin filler.

The ideal soft-tissue filler for wrinkles and skin defects should be safe, biocompatible, resistant to phagocytosis, persist and maintain its volume without being resorbed or degraded. ArteFill, an improved, next-generation derivative of Artecoll, is expected to become the first and only FDA-approved permanent filler for use in the USA in 2006 and will be available worldwide. ArteFill consists of polymethylmethacrylate microspheres suspended in a 3.5% solution of bovine collagen containing 0.3% lidocaine. In this article, the pathophysiology, efficacy and safety of ArteFill are discussed and details of its injection technique are provided. Insight into the pharmacoeconomic value of ArteFill over nonpermanent fillers and ArteFill's unique role in the growing world market of dermal fillers is provided.

Cicatrix↗

American society of maxillofacial surgeons outcome study: preoperative and postoperative neurodevelopmental findings in single-suture craniosynostosis.

The purpose of this study was to prospectively determine the neurodevelopmental effects associated with single-suture, nonsyndromic craniosynostosis before and after surgery. Children diagnosed with single-suture craniosynostosis were evaluated by a psychologist using the Bayley Scales of Infant Development-Second Edition (BSID-II) within 2 months before and again 1 year after surgical correction. The BSID-II is a widely used measure of infant cognitive and motor development. The scale consists of three parts, the Mental Developmental Index (MDI), the Psychomotor Developmental Index (PDI), and the Behavior Rating Scale. The MDI and PDI yield age-standard scores (mean, 100; SD, 16). The children ranged in age from 2.5 to 10 months at the time of the craniofacial reconstruction (average age, 5.9 months). Metopic synostosis was diagnosed in 23 percent, sagittal synostosis in 45 percent, and unilateral coronal synostosis in 32 percent of patients. Twenty-two patients were evaluated preoperatively, of whom 15 patients were evaluated postoperatively. Mean baseline BSID-II scores revealed a mild delay in mental and motor scores (MDI, 82.3; PDI, 79.5). Mean postoperative BSID-II scores still revealed a mild delay in mental scores but significantly improved motor scores (MDI, 79.3; PDI, 89.3). Of the 15 children, four (27 percent) had BSID-II evaluations that were in the average range for all scales and nine infants (60 percent) had at least one MDI or PDI score in the significantly delayed range (<70). Among children with single-suture nonsyndromic craniosynostosis, mean Bayley scores indicated mild baseline deficits in both mental and motor scores. After surgical treatment, improvement was seen in the motor scale. It appears from this sample that neurodevelopmental abnormalities may be present in children with single-suture synostosis, and some may persist at 1 year of follow-up.

Cranial Sutures↗

Artecoll: a long-lasting injectable wrinkle filler material: Report of a controlled, randomized, multicenter clinical trial of 251 subjects.

Artecoll, an injectable wrinkle filler composed of polymethylmethacrylate microspheres and bovine collagen, is widely available outside the United States. For domestic availability, a multicenter Investigational Device Exemption study was required by the U.S. Food and Drug Administration. This study consisted of 251 subjects at eight centers who received injections of Artecoll or the currently approved collagen dermal filler (control) in 1334 wrinkles of the glabella, nasolabial fold, radial upper lip lines, and corner-of-the-mouth lines. The treatments were randomized, and follow-up safety, efficacy, investigator success rating, and subject satisfaction rating data were collected at 1, 3, and 6 months. The safety data, measured as adverse events and immunoglobulin G serum levels, were low and similar for both groups. The efficacy data, measured by masked observers using a photographic facial fold assessment scale, demonstrated a combined significant improvement with Artecoll compared with collagen at 6 months (p < 0.001). At 6 months, the investigator success ratings and the subject satisfaction ratings for each of the four injections sites were superior for Artecoll (p < 0.001). In the Artecoll group, 12-month follow-up was obtained for 111 subjects (86.7 percent) and showed persistence of significant augmentation. Artecoll had fewer adverse events reported throughout the 12-month safety study period than the control group did in 6 months, although the difference was not statistically significant.

Adult↗

Craniofacial reconstruction with a fast resorbing polymer: a 6- to 12-month clinical follow-up review.

OBJECT: Resorbable polymer implants have become a compelling option in the treatment of acquired and congenital craniofacial deformities. In particular, the resorbable polylactide and polyglycolide polymers have demonstrated excellent safety profiles in multiple in vitro, animal, and clinical studies and are currently being used in a wide variety of craniofacial applications. In pediatric craniofacial reconstruction a desirable attribute of fixation is early resorption, which may limit the duration of any effect on cranial growth. In this paper the authors discuss the biomaterial properties of a fast resorbing polymer (FRP) and the clinical results in a series of patients who participated in a 6- to 12-month study. METHODS: The authors performed craniofacial reconstruction by using FRP implants in 29 patients beginning in August 2002. All patients experienced maintenance of stable bone fixation followed by bone healing. Cosmetic results were rated satisfactory or excellent, except for one unsatisfactory cosmetic result caused by disease progression. CONCLUSIONS: Results of this study support the effectiveness of an FRP implant in a variety of craniofacial surgical procedures including craniosynostoses, fibrous dysplasia, cranial defects, and encephaloceles.

Absorbable Implants↗

Genetic association of cutaneous neonatal lupus with HLA class II and tumor necrosis factor alpha: implications for pathogenesis.

OBJECTIVE: Cutaneous neonatal lupus resembles subacute cutaneous lupus erythematosus (SCLE), and photosensitivity is a common symptom. Tumor necrosis factor alpha (TNFalpha) release by ultraviolet light-exposed keratinocytes may be exaggerated in SCLE patients who have the haplotype TNFalpha -308A;DRB1*03. Accordingly, this study was undertaken to seek genetic and histologic evidence for a role of TNFalpha in the pathogenesis of cutaneous neonatal lupus. METHODS: DNA was isolated from 83 children (22 with rash, 35 with congenital heart block [CHB], 26 unaffected siblings) and 58 mothers from the Research Registry for Neonatal Lupus. RESULTS: The -308A allele (associated with higher TNFalpha production), HLA-DRQB1*02, and HLA-DRB1*03 were each present in the majority of children with rash (64%, 68%, and 64%, respectively). The frequency of all 3 6p alleles occurring together in 1 individual was greater in children with rash than in children who had either CHB or no manifestation of neonatal lupus (59% versus 30%; P = 0.02). This association with neonatal lupus rash was equivalent to published findings in a cohort of patients with SCLE, but significantly greater than the association in patients with discoid lupus erythematosus. Prominent TNFalpha staining in the epidermis was observed in lesional skin from 3 children with rash, but not in skin from a healthy neonate. CONCLUSION: Taken together, the finding of a genetic predisposition to generate increased levels of TNFalpha following tissue injury and the histologic demonstration of TNFalpha in the target organ support the notion that this inflammatory cytokine plays a role in the pathogenesis of cutaneous neonatal lupus. Furthermore, the results of these studies provide evidence of a biologic link between neonatal lupus and the rash of SCLE.

Epidermis↗

MacroPore resorbable devices in craniofacial surgery.

Resorbable polymer implants have become a compelling option in the treatment of acquired and congenital craniofacial deformities. The resorbable polylactide (PLa) and polyglycolide (PGa) polymers in particular have demonstrated excellent safety profile sin multiple in vitro, animal, and clinical studies and are currently being used in a wide variety of craniofacial applications. In this article, the authors discuss the biomaterial properties of PLa and PGa resorbable implants and provide an overview of the use of these polymers in craniofacial surgery. They conclude by relating their experience with an ongoing clinical series using MacroPore PLDLa and FRP implants for various applications,including Le Fort osteotomies, midface/monobloc internal distraction, and craniosynostosis reconstruction.

Absorbable Implants↗

Fronto-orbital and cranial osteotomies with resorbable fixation using an endoscopic approach.

Over the past 3 years the authors have used modified minimally invasive endoscopic techniques in the surgical correction of craniosynostosis. For selected patients, these techniques offer an alternative to traditional techniques, minimizing postoperative morbidity and the need for cranial banding. Long-term follow-up will be needed to assess the ultimate efficacy of these techniques. Traditional techniques for repair of craniosynostosis have historically had a record of excellent aesthetic results with acceptable morbidity. Ultimately, each patient is best served by a customized plan, developed and implemented by a multidisciplinary team capable of the full range of techniques.

Absorbable Implants↗

Idiopathic splinter hemorrhages.

Splinter hemorrhages are non-blanchable usually distal reddish-brown linear hemorrhages beneath the nails. Among a variety of etiologic factors reported, trauma is the most common cause. A 26-year-old Hispanic female presented with asymptomatic, extensive fingernail hemorrhages of two months duration. There was no history of physical trauma to the nails. Treatment with a topical antifungal medication for one month produced no improvement. The past medical history was noncontributory. Extensive laboratory testing revealed no underlying systemic disease. Three months after the initial presentation, 6 of 10 fingernails showed signs of resolution without treatment. We conclude that idiopathic atraumatic subungual splinter hemorrhages can occur in healthy individuals. Spontaneous resolution occurred in our patient.

Adult↗

Scrotal calcinosis: is the cause still unknown?

Scrotal calcinosis is a rare benign entity of calcified nodules within the scrotal skin. We describe a healthy 25-year-old man with multiple asymptomatic calcified nodules restricted to the scrotum. Histologic studies of multiple nodules showed calcium deposition, and basophilic material with sparse inflammation surrounded by a fibrous capsule. Because the intensive evaluation of our patient failed to reveal a cause, an analysis of all 123 cases found in the literature was conducted. Several plausible origins for scrotal calcinosis are disclosed; however, pathogenesis of this condition remains equivocal and controversial. The most common treatment option is excision of the affected nodules. Our report underscores the need for further investigation of this florid and bizarre disorder.

Adult↗

Predicting the risk of reoperation in metopic synostosis: a quantitative CT scan analysis.

Children with metopic synostosis have a well-described clinical picture of trigonocephaly, often with hypotelorbitism. The craniofacial disorder itself is well recognized; however, objective prognostic factors for predicting the risk of reoperation are not well known. In 39 children with metopic synostosis, measurements of the cranial length, cranial width, anterior intercoronal distance, anterior interorbital distance (intercanthal distance), lateral orbital distance, and interzygomatic buttress distance were taken from preoperative computed tomographic (CT) scans and were normalized relative to each child's age. To separate overall facial hypoplasia from regional hypoplasia, a ratio of intercanthal distance to interzygomatic buttress distance was determined. These prognostic factors were analyzed with respect to reoperation rate. A stepwise logistic regression analysis was used to determine the interrelationships between the prognostic factors. Twenty-eight percent of the children underwent reoperation (N=11, 1 total reoperation and 10 minor recontouring). All of the reoperations occurred in children with a decreased intercanthal distance (p=0.30). The ratio of intercanthal distance to midfacial width was related to reoperation rate, with those children who had a ratio < or =0.80 having a reoperation rate of 44% (8 of 18 total children with an intercanthal-to-zygomatic ratio < or =0.8, p=0.07). This relationship was significant in children younger than the age of 12 months (6 of 13 total children with an intercanthal-to-zygomatic ratio < or =0.8, 46% reoperation rate, p=0.006). This study suggests that preoperative CT measurements can be used as a means of risk stratification in outcome analyses of the surgical treatment of craniosynostosis. In children treated for metopic suture synostosis, a foreshortened intercanthal distance compared with the interzygomatic buttress distance was related to reoperation rate, especially in children younger than 12 months of age.

Cranial Sutures↗