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1.
J Hand Surg Am ; 47(4): 385.e1-385.e8, 2022 04.
Artigo em Inglês | MEDLINE | ID: mdl-34154855

RESUMO

PURPOSE: The combined treatment of trapeziometacarpal joint arthritis and scapholunate advanced collapse (SLAC) wrist presents unique challenges. The consequences of the loss of radial column support caused by scaphoidectomy and trapeziectomy are not well known. The purpose of this study was to evaluate the outcomes of the simultaneous and staged treatment of trapeziometacarpal joint arthritis and SLAC wrist. METHODS: A retrospective review of patients who underwent surgery for both trapeziometacarpal joint arthritis and SLAC wrist was performed. The wrist and thumb range of motion; grip and pinch strength; pain; quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) scores; and radiographs were analyzed. RESULTS: Twenty-four patients who underwent both trapeziectomy and 1 of 3 procedures for SLAC wrist (4-corner fusion [n = 10]), proximal row carpectomy [n = 9], and total wrist arthroplasty [n = 5]) in a single stage (n = 10) or in 2 stages (n = 14) were included. The median age was 63 years. The median follow-up period was 35 months. Twelve (50%) patients underwent complete scaphoidectomy, and 12 (50%) patients underwent partial scaphoidectomy. All 3 procedures resulted in an improvement in pain at rest, pain during activity, and quick Disabilities of the Arm, Shoulder and Hand scores. The final range of motion, grip and pinch strength, and complication rates were consistent with those reported in the literature for isolated procedures. CONCLUSIONS: Trapeziometacarpal joint arthritis and SLAC wrist may be treated either simultaneously or in stages. TYPE OF STUDY/LEVEL OF EVIDENCE: Therapeutic V.


Assuntos
Artropatias , Osteoartrite , Força da Mão , Humanos , Pessoa de Meia-Idade , Osteoartrite/diagnóstico por imagem , Osteoartrite/cirurgia , Dor , Amplitude de Movimento Articular , Punho , Articulação do Punho/cirurgia
2.
Neuromodulation ; 24(6): 971-982, 2021 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-33098229

RESUMO

INTRODUCTION: Complex regional pain syndrome (CRPS), formerly known as reflex sympathetic dystrophy (RSD), is a difficult to treat condition characterized by debilitating pain and limitations in functional ability. Neuromodulation, in the form of spinal cord stimulation (SCS) and peripheral nerve stimulation (PNS), have been traditionally used as a treatment for CRPS with variable success. OBJECTIVE: This chart review describes the use of implantable PNS systems in the treatment of CRPS of the upper and lower extremities spanning nearly three decades. MATERIALS AND METHODS: A retrospective chart review was performed on 240 patients with PNS implanted between 1990 and 2017 at our institution. Of these, 165 patients were identified who had PNS systems implanted for a diagnosis of CRPS. Patient profile, including baseline characteristics, comorbidities, past/current interventions/medications and targeted nerves, was descriptively summarized through standard summary statistics. Patients' pain scores and opioid consumptions at baseline (preimplant), 1 month, 6 months, and 12 months were collected and compared. Device revisions and explants were summarized, and patient functional outcomes were described. RESULTS: Pain scores at baseline and at 12-month follow-up were decreased from a mean of 7.4 ± 1.6 to 5.5 ± 2.4 and estimated to be 1.87 (95% CI: [1.29, 2.46], paired t-test p-value <0.001) lower at 12 months. At baseline, 62% of patients were on chronic opioid therapy, compared with 41% at 12 months. Of 126 patients who reported changes in functional status, 64 (51%) reported improvement, 27 (21%) reported worsening, and 35 (28%) did not report any meaningful change. Excluding end-of-life battery replacements, surgical revision occurred in 56 (34%) of patients. Thirteen patients (8%) underwent implantation of a second PNS because of symptomatic expansion outside of the original painful region. Device explant was performed in 32 (19%) of patients. Median length of follow-up was 74 [14, 147] months. Of the 36 patients who continue to follow-up at our institution, 29 (81%) continue to use their PNS. CONCLUSIONS: We can conclude that PNS is a useful modality to improve function and reduce long-term pain in selected patients suffering from CRPS type I and type II.


Assuntos
Síndromes da Dor Regional Complexa , Distrofia Simpática Reflexa , Estimulação da Medula Espinal , Síndromes da Dor Regional Complexa/terapia , Humanos , Nervos Periféricos , Distrofia Simpática Reflexa/terapia , Estudos Retrospectivos
3.
Ann Plast Surg ; 82(3): 320-329, 2019 03.
Artigo em Inglês | MEDLINE | ID: mdl-30633023

RESUMO

BACKGROUND: We report new data for a rare face transplant performed 3 years ago. Granulomatosis with polyangiitis (GPA) (Wegener) is a severe autoimmune necrotizing vasculitis and parenchymal inflammatory disease that can affect any organ including those of the craniofacial region. Skin involvement manifests as malignant pyoderma. This account (1) highlights the technical details of face transplantation for this unique indication, (2) reports the 3-year posttransplant outcome, and (3) describes relevant immunological aspects. METHODS: A Le Fort III near-total face and near-total scalp transplant was performed after extensive trauma and subsequent bone and soft tissue infection in a patient with GPA. Incisions were planned along facial aesthetic subunits. The vascular pedicle comprised the facial and superficial temporal arteries bilaterally. The functioning left eye was preserved and fitted into the donor tissues. RESULTS: The procedure took 21 hours, and transfusion was limited to 4 units of packed red cells. Early medical and surgical complications were successfully treated. At 3 years, acceptable aesthetic outcome was achieved with adequate color match and scalp hair growth. The patient has recovered light touch, temperature, and 2-point discrimination and has evidence of symmetric cheek elevation albeit with limited eyelid and frontalis function. GPA relapse did not occur. Four acute rejections were fully reversed. CONCLUSIONS: This case represents a new underlying disease (trauma + GPA) leading to face transplantation and a unique clinical scenario where allografting was indicated for potentially life-threatening and sight-preserving reasons and not for mere functional and aesthetic concerns. Despite complexity, 3-year clinical outcome is encouraging, and the patient is no longer at risk for dural exposure, meningitis, and related morbidity.


Assuntos
Traumatismos Faciais/complicações , Transplante de Face/métodos , Granulomatose com Poliangiite/cirurgia , Imageamento Tridimensional , Cicatrização/fisiologia , Adulto , Progressão da Doença , Traumatismos Faciais/diagnóstico , Traumatismos Faciais/cirurgia , Seguimentos , Sobrevivência de Enxerto , Granulomatose com Poliangiite/etiologia , Granulomatose com Poliangiite/fisiopatologia , Humanos , Escala de Gravidade do Ferimento , Masculino , Duração da Cirurgia , Cuidados Pré-Operatórios/métodos , Qualidade de Vida , Medição de Risco , Doadores de Tecidos , Tomografia Computadorizada por Raios X/métodos , Transplante Homólogo , Resultado do Tratamento
4.
Microsurgery ; 38(6): 706-717, 2018 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-28738446

RESUMO

BACKGROUND: Arteriovenous (AV) loops can be utilized in a single- or two-stage approach in free flap reconstruction when proper vessels are not available. However, there exists no consensus on which method leads to superior microsurgical and patient outcomes. The purpose of this article was to review single- versus two-stage AV loops utilized in free flap reconstruction with a focus on complications and overall outcomes. METHODS: A systematic review of AV loops for autologous free tissue transfer was conducted. Endpoints investigated included flap characteristics, timing to second stage, complications, and outcomes. A Student's t-test and forest plots were used for statistical analysis. RESULTS: Thirty-five unique papers discussed utilizing AV loops in a single- or two-stage approach, yielding 260 and 98 single- and two-stage AV loops, respectively. There was a statistically significant higher rate of major complications in two-stage as compared to single-stage AV loops. There was a non-statistically significant difference in rate of minor complications in the single-stage as compared to two-stage AV loops. Overall, there was a statistically significant higher success rate in the single-stage as compared to two-stage AV loops CONCLUSION: There was a statistically significant higher rate of major complications and failures in two-stage AV loops. As well-conducted randomized controlled studies are nearly impossible to perform in this population, the decision to pursue a single- versus two-stage reconstruction should ultimately be determined based on individual patient co-morbidities, the size and etiology of defect, and the type of free tissue transfer planned.


Assuntos
Derivação Arteriovenosa Cirúrgica/métodos , Microcirurgia/métodos , Procedimentos de Cirurgia Plástica/métodos , Retalhos Cirúrgicos/irrigação sanguínea , Humanos
5.
Ann Plast Surg ; 78(3): 342-346, 2017 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-26954747

RESUMO

BACKGROUND: The medial gastrocnemius muscle flap is commonly used for the reconstruction of defects around the knee and proximal leg. The flap can be raised using either a medial or a posterior midline incision, although no studies have been done comparing the 2 different surgical approaches. METHODS: We compared the reach of the medial gastrocnemius muscle flap using either of the 2 incisions in a series of 25 fresh cadavers. All muscle flaps were elevated without division of the muscle origin. Muscle reach was calculated using the distance from a fixed bony point with the leg fully extended and the muscle under no tension. Muscle width measurements were used to calculate surface area of coverage. RESULTS: Muscle flaps elevated through the posterior midline incision group reached 2.02 cm farther than flaps through the medial incision (P < 0.05). This resulted in 20.3 cm increase in surface area for the posterior midline incision group over the medial incision group (P < 0.05). The posterior midline incision allowed for better visualization of the vascular pedicle and dissection of fascial attachments around the pes anserinus. CONCLUSIONS: The posterior midline incision for the elevation of the medial gastrocnemius pedicled muscle flap allows for a safe, thorough mobilization of the muscle resulting in increased muscle reach and increased surface area when compared with the medial incision. Furthermore, the posterior midline incision provides better access to the gastrocnemius muscle origin and the lateral muscle head.


Assuntos
Perna (Membro)/cirurgia , Músculo Esquelético/cirurgia , Procedimentos de Cirurgia Plástica/métodos , Retalhos Cirúrgicos/cirurgia , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Masculino , Pessoa de Meia-Idade
6.
Lancet ; 374(9685): 203-9, 2009 Jul 18.
Artigo em Inglês | MEDLINE | ID: mdl-19608265

RESUMO

BACKGROUND: Multiple reconstructive procedures are common for the reconstruction of complex facial deformities of skin, soft tissues, bony structures, and functional subunits, such as the nose, lips, and eyelids. However, the results have been unsatisfactory. An innovative approach entailing a single surgical procedure of face allograft transplantation is a viable alternative and gives improved results. METHODS: On Dec 9, 2008, a 45-year-old woman with a history of severe midface trauma underwent near-total face transplantation in which 80% of her face was replaced with a tailored composite tissue allograft. We addressed issues of immunosuppressive therapy, psychological and ethical outcomes, and re-integration of the patient into society. FINDINGS: After the operation, the patient did well physically and psychologically, and tolerated immunosuppression without any major complication. Routine biopsy on day 47 after transplantation showed rejection of graft mucosa; however, a single bolus of corticosteroids reversed rejection. During the first 3 weeks after transplantation, the patient accepted her new face; 6 months after surgery, the functional outcome has been excellent. In contrast to her status before transplantation, the patient can now breathe through her nose, smell, taste, speak intelligibly, eat solid foods, and drink from a cup. INTERPRETATION: We show the feasibility of reconstruction of severely disfigured patients in a single surgical procedure using composite face allotransplantation. Therefore, this should be taken in consideration as an early option for severely disfigured patients. FUNDING: None.


Assuntos
Traumatismos Faciais/cirurgia , Transplante de Face/métodos , Imagem Corporal , Seleção do Doador , Terapia por Exercício , Traumatismos Faciais/diagnóstico por imagem , Traumatismos Faciais/etiologia , Transplante de Face/ética , Transplante de Face/psicologia , Transplante de Face/reabilitação , Feminino , Rejeição de Enxerto/diagnóstico , Rejeição de Enxerto/etiologia , Rejeição de Enxerto/prevenção & controle , Humanos , Terapia de Imunossupressão/efeitos adversos , Terapia de Imunossupressão/métodos , Pessoa de Meia-Idade , Equipe de Assistência ao Paciente/organização & administração , Seleção de Pacientes , Radiografia , Recuperação de Função Fisiológica , Obtenção de Tecidos e Órgãos , Transplante Homólogo , Resultado do Tratamento , Estados Unidos , Ferimentos por Arma de Fogo/complicações
7.
Ann Plast Surg ; 65(5): 471-4, 2010 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-20948427

RESUMO

BACKGROUND: To the best of our knowledge, there have been no previous studies evaluating the correlation of the US economy and hand surgery volume. Therefore, in light of the current recession, our objective was to study our institution's hand surgery volume over the last 17 years in relation to the nation's economy. METHODS: A retrospective analysis of our institution's hand surgery volume, as represented by our most common procedure (ie, carpal tunnel release), was performed between January 1992 and October 2008. Liposuction and breast augmentation volumes were chosen to serve as cosmetic plastic surgery comparison groups. Pearson correlation statistics were used to estimate the relationship between the surgical volume and the US economy, as represented by the 3 market indices (Dow Jones, NASDAQ, and S&P500). RESULTS: A combined total of 7884 hand surgery carpal tunnel release (open or endoscopic) patients were identified. There were 1927 (24%) and 5957 (76%) patients within the departments of plastic and orthopedic surgery, respectively. In the plastic surgery department, there was a strong negative (ie, inverse relationship) correlation between hand surgery volume and the economy (P < 0.001). In converse, the orthopedic department's hand surgery volume demonstrated a positive (ie, parallel) correlation (P < 0.001). The volumes of liposuction and breast augmentation also showed a positive correlation (P < 0.001). CONCLUSION: To our knowledge, we have demonstrated for the first time an inverse (ie, negative) correlation between hand surgery volumes performed by plastic surgeons in relation to the US economy, as represented by the 3 major market indices. In contrast, orthopedic hand surgery volume and cosmetic surgery show a parallel (ie, positive) correlation. This data suggests that plastic surgeons are increasing their cosmetic surgery-to-reconstructive/hand surgery ratio during strong economic times and vice versa during times of economic slowdown.


Assuntos
Síndrome do Túnel Carpal/cirurgia , Descompressão Cirúrgica/estatística & dados numéricos , Economia , Gastos em Saúde , Cirurgia Plástica/estatística & dados numéricos , Síndrome do Túnel Carpal/diagnóstico , Estudos de Coortes , Análise Custo-Benefício , Descompressão Cirúrgica/economia , Feminino , Mãos/cirurgia , Humanos , Incidência , Masculino , Valores de Referência , Estudos Retrospectivos , Fatores de Risco , Cirurgia Plástica/economia , Estados Unidos , Carga de Trabalho
8.
J Knee Surg ; 33(7): 732-744, 2020 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-30959536

RESUMO

Deep soft tissue defects after complicated primary or revision total knee arthroplasty (TKA) can be devastating to the patient and technically challenging. The purpose of this review was to (1) discuss different methods used to provide coverage for deep defects of the knee following TKA, as well as to (2) report on their success rates. A comprehensive literature search was performed. Reports were only included if they (1) were case series, (2) were level III studies or above (including retrospective cohort studies and meta-analyses), (3) were in English, and (4) discussed the outcome of graft or flap coverage of soft tissue defects after total knee arthroplasty. A total of 28 case series and four retrospective comparative studies were retrieved. In 16 studies, 195 out of 241 patients who received gastrocnemius flaps (81%) experienced successful outcomes. In seven studies including 84 patients that underwent fasciocutaneous flap coverage, over 90% of patients experienced successful outcomes. In the four studies examining 144 patients with delayed versus prophylactic soft tissue reconstruction, up to 81% of patients experienced a successful outcome. Various factors must be taken into consideration when assessing full-thickness defects over a TKA and collaboration between plastic and orthopaedic surgeons is required to select the optimal approach.


Assuntos
Artroplastia do Joelho/efeitos adversos , Retalhos Cirúrgicos , Humanos
9.
Ann Plast Surg ; 63(5): 564-71, 2009 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-19806047

RESUMO

Ischemia-reperfusion injury (IRI) is a common and serious complication of reperfusion following vascular occlusion. We present a novel interpretation of the pathogenesis of IRI. According to this hypothesis, anoxia resulting from ischemia allows translocation of phosphatidylserine to the surface of endothelial cells (ECs), providing an attachment site for leukocytes and platelets. This attachment impedes blood flow through the microvasculature. During IRI mediators of increased vascular permeability are produced, resulting in edema. We have developed a recombinant homodimer of human Annexin V, Diannexin, to attenuate IRI. Annexin V (36 kDa) rapidly passes from the circulation into the urine. In Diannexin 2 annexin V molecules are joined by a short peptide linker to produce a 73 kDa protein, which exceeds the renal filtration threshold. Diannexin has a half-life of about 2.5 hours in the human circulation. Diannexin also has a higher affinity for phosphatidylserine on cell surfaces than the monomer has. Such binding inhibits leukocyte attachment to ECs, and inflammatory mediator formation, during IRI. The aim of the study now reported was to ascertain the effects of Diannexin on IRI in the rat cremaster muscle flap, as revealed by intravital microscopy. During IRI there was increased attachment of leukocytes to ECs, reduced blood flow and augmented vascular permeability. Administration of Diannexin before or just after ischemia prevented these effects. Diannexin inhibited transmigration of leukocytes during IRI. Edema complicates peripheral vascular surgery, stroke, and other clinical conditions. Diannexin has proven to be safe when administered to patients after major surgical operations, and it may be useful to prevent IRI associated with peripheral vascular surgery.


Assuntos
Anexina A5/farmacologia , Endotélio Vascular/fisiopatologia , Inibidores Enzimáticos/farmacologia , Traumatismo por Reperfusão/fisiopatologia , Retalhos Cirúrgicos/irrigação sanguínea , Animais , Anexina A5/uso terapêutico , Movimento Celular/efeitos dos fármacos , Leucócitos/efeitos dos fármacos , Leucócitos/fisiologia , Masculino , Microcirculação , Ratos , Ratos Endogâmicos Lew , Traumatismo por Reperfusão/prevenção & controle
10.
J Hand Surg Eur Vol ; 43(10): 1054-1058, 2018 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-29558847

RESUMO

We studied anomalies of the common digital arteries by dissecting 33 fresh cadaver hands under magnification. In the majority of the dissected hands (25 hands), common digital arteries took off from the superficial palmar arch and ran superficial and parallel to the flexor tendons. Variations were found in eight out of 33 hands. In four hands the common digital artery to the second web space was replaced by an atypical vessel, originating from the deep palmar arch, that crossed posterior to the index flexor tendons proximal to the A1 pulley. In eight hands, the common digital artery to the fourth web space was replaced by an atypical deeper vessel, originating from the superficial palmar arch and crossing posterior to the little finger flexors. No nerve anomalies were identified. Unrecognized, these atypical arteries to the second and/or fourth web spaces could lead to vascular complications during surgery, especially pollicization.


Assuntos
Artérias/anormalidades , Mãos/irrigação sanguínea , Cadáver , Humanos
11.
Plast Reconstr Surg ; 137(1): 177e-186e, 2016 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-26710050

RESUMO

BACKGROUND: Insufficient soft-tissue coverage following total knee arthroplasty jeopardizes prosthesis retention and may lead to significant complications. The aim of this study was to evaluate the natural history of total knee arthroplasty following flap reconstruction of soft-tissue defects. METHODS: A retrospective review of patients treated with flaps after failed total knee arthroplasty between 1998 and 2013 was conducted. Patients with preexisting soft-tissue defects who required reactive flap reconstruction were included in group 1. Patients with no preexisting soft-tissue defects, but with extensive débridement during revision total knee arthroplasty requiring immediate proactive flap coverage, were included in group 2. RESULTS: Fifty-eight patients in group 1 were treated with 86 flaps, and 15 patients in group 2 were treated with 17 flaps. Mean length of follow-up was 67.0 and 54.7 months, respectively (p = 0.21). Flap-related complications and number of subsequent flap revisions were comparable in both groups. Patients in group 1 had a higher rate of implant reinfection (58 percent versus 27 percent; p < 0.05), amputations (25 percent versus 0 percent; p < 0.05), and subsequent prosthesis revisions (2.2 versus 0.9; p < 0.05). Functional joint was preserved in 54 percent and 80 percent of cases, respectively. Mean gain in range of motion and quality of life were significantly better in group 2 (p < 0.05). CONCLUSIONS: Early proactive soft-tissue coverage of total-knee arthroplasty is critical to long-term success. In cases where reactive treatment is required, significantly worse outcomes and a high rate of complications should be expected. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, III.


Assuntos
Artroplastia do Joelho/métodos , Fáscia/transplante , Músculo Esquelético/transplante , Osteoartrite do Joelho/cirurgia , Transplante de Pele/métodos , Lesões dos Tecidos Moles/cirurgia , Retalhos Cirúrgicos , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Osteoartrite do Joelho/complicações , Qualidade de Vida , Procedimentos de Cirurgia Plástica/métodos , Estudos Retrospectivos , Lesões dos Tecidos Moles/complicações , Fatores de Tempo
12.
Plast Reconstr Surg ; 137(6): 1007e-1015e, 2016 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-27219252

RESUMO

BACKGROUND: Granulomatosis with polyangiitis (Wegener granulomatosis) is a rare disease that commonly starts in the craniofacial region and can lead to considerable facial disfigurement. Granulomas and vasculitis, however, can involve many other tissues (especially pulmonary and renal). Dermatologic and subcutaneous components can lead to malignant pyoderma. METHODS: The authors describe a unique pathologic condition, where significant Le Fort type trauma was associated with subsequent development of granulomatosis with polyangiitis and malignant pyoderma. Successive operations to excise necrotic tissue and reconstruct the defects were followed by worsening inflammation and tissue erosions. Trauma and surgery in proximity to the eye and sinuses masked the initial clinical presentation and led to delay in diagnosis and disease progression. The resultant facial disfigurement and tissue loss were substantial. RESULTS: Despite multiple confounding factors, accurate diagnosis was eventually established. This was based on persistence of sinus inflammations in the absence of infective agents, proven sterility of lung lesions, and antineutrophil cytoplasmic antibody positivity with proteinase 3 specificity. Skin lesion biopsy specimens were identified as pyoderma gangrenosum and later as malignant pyoderma. Institution of immunosuppressive therapy allowed successful control of the disease and wound healing. The resulting craniofacial destruction, however, necessitated facial vascularized composite allotransplantation. CONCLUSION: Recognition of this rare pathologic association is essential, to prevent delays in diagnosis and treatment that can lead to major craniofacial tissue loss. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, V.


Assuntos
Aloenxertos Compostos/cirurgia , Transplante de Face/métodos , Granulomatose com Poliangiite/cirurgia , Fraturas Maxilares/complicações , Fraturas Maxilares/cirurgia , Microdiálise , Complicações Pós-Operatórias/cirurgia , Pioderma/cirurgia , Adulto , Aloenxertos , Terapia Combinada , Desbridamento , Diagnóstico Diferencial , Progressão da Doença , Seguimentos , Granulomatose com Poliangiite/diagnóstico , Humanos , Masculino , Fraturas Maxilares/diagnóstico , Complicações Pós-Operatórias/diagnóstico , Reoperação
13.
J Manag Care Spec Pharm ; 21(1): 23-34, 2015 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-25562770

RESUMO

BACKGROUND: The Biologics Price Competition and Innovation Act, introduced as part of the Affordable Care Act, directed the FDA to create an approval pathway for biologic products shown to be biosimilar or interchangeable with an FDA-approved innovator drug. These biosimilars will not be chemically identical to the reference agent. Investigational studies conducted with biosimilar agents will likely provide limited real-world evidence of their effectiveness and safety. How do we best monitor effectiveness and safety of biosimilar products once approved by the FDA and used more extensively by patients? OBJECTIVE: To determine the feasibility of developing a distributed research network that will use health insurance plan and health delivery system data to detect biosimilar safety and effectiveness signals early and be able to answer important managed care pharmacy questions from both the government and managed care organizations. METHODS: Twenty-one members of the AMCP Task Force on Biosimilar Collective Intelligence Systems met November 12, 2013, to discuss issues involved in designing this consortium and to explore next steps. RESULTS: The task force concluded that a managed care biosimilars research consortium would be of significant value. Task force members agreed that it is best to use a distributed research network structurally similar to existing DARTNet, HMO Research Network, and Mini-Sentinel consortia. However, for some surveillance projects that it undertakes, the task force recognizes it may need supplemental data from managed care and other sources (i.e., a "hybrid" structure model). CONCLUSIONS: The task force believes that AMCP is well positioned to lead the biosimilar-monitoring effort and that the next step to developing a biosimilar-innovator collective intelligence system is to convene an advisory council to address organizational governance.


Assuntos
Medicamentos Biossimilares/efeitos adversos , Medicamentos Biossimilares/uso terapêutico , Coleta de Dados/métodos , Aprovação de Drogas , Humanos , Assistência Farmacêutica/organização & administração , Estados Unidos , United States Food and Drug Administration
14.
Plast Reconstr Surg ; 125(1): 111-122, 2010 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-19770815

RESUMO

BACKGROUND: Severe complex facial injuries are difficult to reconstruct and require multiple surgical procedures. The potential of performing complex craniofacial reconstruction in one surgical procedure is appealing, and composite face allograft transplantation may be considered an alternative option. The authors describe establishment of the Cleveland Clinic face transplantation program that led them to perform the first U.S. near-total face transplantation. METHODS: In November of 2004, the authors received the world's first institutional review board approval to perform a face transplant in humans. In December of 2008, after a 22-hour operation, the authors performed the first near-total face transplantation in the United States, replacing 80 percent of the patient's traumatic facial deficit with a composite allograft from a brain-dead donor. This largest, and most complex, face allograft in the world included over 535 cm2 of facial skin; functional units of full nose with nasal lining and bony skeleton; lower eyelids and upper lip; underlying muscles and bones, including orbital floor, zygoma, maxilla, alveolus with teeth, hard palate, and parotid glands; and pertinent nerves, arteries, and veins. Immunosuppressive treatment consisted of thymoglobulin, tacrolimus, mycophenolate mofetil, and prednisone. RESULTS: The patient tolerated the procedure and immunosuppression well. At day 47 after transplantation, routine biopsy showed rejection of the graft mucosa without clinical evidence of skin or graft rejection. The patient's physical and psychological recovery went well. The functional outcome has been excellent, including optimal return of breathing through the nose, smelling, tasting, speaking, drinking from a cup, and eating solid foods. CONCLUSION: The functional outcome thus far at 8 months is rewarding and confirms the feasibility of performing complex reconstruction of severely disfigured patients in a single surgical procedure of facial allotransplantation.


Assuntos
Traumatismos Faciais/cirurgia , Transplante de Face , Procedimentos de Cirurgia Plástica/métodos , Adulto , Protocolos Clínicos , Transplante de Face/métodos , Feminino , Humanos , Traumatismo Múltiplo/cirurgia , Ohio , Seleção de Pacientes , Recuperação de Função Fisiológica , Transplante Homólogo , Ferimentos por Arma de Fogo/cirurgia
15.
Arch Facial Plast Surg ; 11(6): 369-77, 2009.
Artigo em Inglês | MEDLINE | ID: mdl-19917898

RESUMO

OBJECTIVE: To discuss the technical and anatomical analysis and design of an osteocutaneous allograft transplant incorporating the donor maxilla and the execution of the operative protocol during the transplant. METHODS: The Cleveland Clinic reported the world's first successful combined face and maxilla transplant in December 2008. Unlike the 3 prior face transplants, this surgical procedure was done as a salvage operation in a patient who had undergone 23 major reconstructive procedures. The additional complexity due to significant postoperative scarring and recipient vessel depletion presented a unique challenge in this case. The extensive 3-dimensional losses of facial structures in multiple tissue planes required a Le Fort III osteomyocutaneous allotransplant incorporating the donor maxilla. RESULTS: We report the first successful transfer of a complete bony framework and soft-tissue envelope. The allograft has shown excellent integration and no long-term rejection. The traditional conception based on anatomical studies suggested that this transfer would require independent dissection of the internal maxillary vascular system. This was not required in our patient whose allograft was based solely on the facial arterial system and its arcades. CONCLUSIONS: Successful near-total face and maxilla allograft transplant can be accomplished based on the facial arterial system and its arcades. This presents a novel method for reconstructing massive facial injuries with significant involvement of the facial skeleton.


Assuntos
Transplante Ósseo/métodos , Traumatismos Faciais/cirurgia , Transplante de Face/métodos , Maxila/transplante , Retalhos Cirúrgicos/irrigação sanguínea , Terapia Combinada , Estética , Face/anatomia & histologia , Face/cirurgia , Traumatismos Faciais/etiologia , Feminino , Seguimentos , Sobrevivência de Enxerto , Humanos , Escala de Gravidade do Ferimento , Imageamento por Ressonância Magnética , Traumatismos Maxilofaciais/etiologia , Traumatismos Maxilofaciais/cirurgia , Pessoa de Meia-Idade , Osteotomia de Le Fort/métodos , Cuidados Pós-Operatórios/métodos , Cuidados Pré-Operatórios/métodos , Procedimentos de Cirurgia Plástica/métodos , Fatores de Tempo , Tomografia Computadorizada por Raios X , Transplante Homólogo , Ferimentos por Arma de Fogo/complicações , Ferimentos por Arma de Fogo/cirurgia
16.
Innovations (Phila) ; 4(5): 278-81, 2009 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-22437168

RESUMO

OBJECTIVE: : Minimally invasive cardiac surgery in patients with breast implants is challenging. Obtaining access to cardiac structures without injuring the prosthesis and at the same time maintaining cosmesis is of particular concern in these patients. Mitral valve surgery can be performed using a right mini-inframammary thoracotomy in female patients with breast implants. We describe our experience with this approach to preserve the cosmetic results of previous breast augmentation. METHODS: : Six female patients with previous breast implantation presented for isolated mitral valve surgery for degenerative disease. Surgery was performed through an inframammary incision, in most cases using the previous surgical incision from breast implantation. Peripheral cannulation was used for cardiopulmonary bypass. The breast prosthesis was explanted through a 6-cm skin incision, and then the mitral valve was approached through a right mini anterior thoracotomy. At the end of mitral surgery, the implant was replaced. RESULTS: : All patients had satisfactory outcomes. The mitral valve was repaired in five patients and replaced in one patient. Average length of stay was 5.3 days (range, 4-8 days). There were no conversions to median sternotomy. There were no bleeding complications. There were no wound complications or implant infections. Cosmesis was preserved. CONCLUSIONS: : Our experience with this approach has allowed both mitral valve repair and replacement at the same time preserving cosmetic results. This minimally invasive technique may also have applications in performing atrial septal defect closure, Maze procedures for atrial fibrillation, and tricuspid valve surgery in patients with breast implants.

17.
J Reconstr Microsurg ; 22(6): 399-405, 2006 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-16894483

RESUMO

This report describes the development of a new technique for harvesting facial allograft for facial transplantation. The coronal-posterior surgical approach for facial/scalp flap harvesting from donor cadavers has been developed to allow extended length to the neurovascular bundles utilized in facial composite allograft transplantation. Cadaveric anatomic dissections were performed to harvest facial/scalp flaps via a posterior-coronal approach. Supraorbital and infraorbital neurovascular bundle lengths were extended by osteotomy of the cranial/orbital bone. The mental nerve lengths were extended into the inferior alveolar neurovascular bundle utilizing a sagittal split ramus osteotomy. This surgical approach extends the length of these craniofacial nerves for future neurorrhaphy. The mean length of the supraorbital, infraorbital, and mental nerves was 3.52 +/- 0.31 cm, 4.65 +/- 0.20 cm, 5.6 +/- 0.14 cm, respectively. Based on anatomical dissection in this cadaver study, the authors introduce a new technique for facial/scalp flap harvesting that extends the neurovascular bundles of sensory nerves of the anterior craniofacial skeleton.


Assuntos
Face/cirurgia , Procedimentos de Cirurgia Plástica/métodos , Retalhos Cirúrgicos , Coleta de Tecidos e Órgãos/métodos , Cadáver , Face/inervação , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Couro Cabeludo/inervação , Couro Cabeludo/cirurgia
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