Alfadamoctocogue pegol para profilaxia secundária em pacientes com Hemofilia A, a partir de 12 anos, previamente tratados e sem inibidor / Alfadamoctocogue pegol for secondary prophylaxis in patients with Hemophilia A, from 12 years, previously treated and sem inhibitor

INTRODUÇÃO: A hemofilia A é uma doença hereditária ligada ao cromossomo X, caracterizada pela deficiência ou anormalidade da atividade coagulante do fator VIII e representa a maioria dos casos de coagulopatias hereditárias, com aproximadamente 10.123 casos no país em 2016. A manifestação clínica mais frequente da doença é a hemorragia musculoesquelética, principalmente os sangramentos intra articulares (hemartroses) que afetam especialmente as articulações do joelho, tornozelo, cotovelo, ombro e coxofemoral. Hemartroses de repetição em uma mesma articulação podem levar à degeneração articular progressiva com perda funcional e, nos casos graves, os sangramentos ocorrem frequentemente sem causa aparente. O tratamento dos pacientes com hemofilia A requer a infusão intravenosa do fator de coagulação deficiente (FVIII), sendo feito sob demanda (tratamento do episódio hemorrágico) ou de forma profilática para manter os seus níveis séricos adequados, prevenindo os episódios hemorrágicos. O Programa de Coagulopatias do Ministério da Saúde disponibiliza o FVIII recombinante com meia-vida padrão para o uso em profilaxia. A tecnologia proposta consiste em um FVIII recombinante com meia-vida estendida. Os produtos com meia-vida estendida foram desenvolvidos mais recentemente com o objetivo de disponibilizar um tempo maior de FVIII na circulação sanguínea, proporcionando um intervalo maior entre as infusões e melhor proteção contra sangramentos. TECNOLOGIA: Alfadamoctocogue pegol. PERGUNTA: O uso de alfadamoctocogue pegol para profilaxia secundária em pacientes com hemofilia A, a partir de 12 anos, previamente tratados (e sem inibidores) é mais seguro, eficaz e custo-efetivo do que o tratamento padrão no SUS? EVIDÊNCIAS CLÍNICAS: O único estudo comparativo apresentado, ainda que com qualidade de evidência baixa, não demonstrou diferença estatisticamente significativa no principal desfecho, taxa anualizada de sangramento, entre a tecnologia proposta e a tecnologia disponibilizada no SUS. Dentre outros potenciais benefícios relacionados a menor frequência de infusão do alfadamoctocogue pegol, apenas um estudo avaliou isoladamente a satisfação dos pacientes com a tecnologia proposta, sem comparação à tecnologia padrão. Na ausência de evidências científicas demonstrando superioridade da tecnologia proposta, o demandante realizou um painel Delphi, com especialistas na área de hemofilia A que atuam no SUS em diferentes regiões do Brasil, que sugeriu que os pacientes mais beneficiados com o uso do alfadamoctocogue pegol seriam aqueles com perfil sangrador, farmacocinética desfavorável, baixa adesão ao tratamento e com alta atividade diária. AVALIAÇÃO ECONÔMICA: Um estudo de custo-minimização foi construído baseado na premissa do estudo de Batt, 2019 de que ambas as tecnologias possuem a mesma eficácia. Foram construídos cenários para início do tratamento em diferentes faixas etárias (12 e 30 anos) e cenários para diferentes utilizações de UIs dos medicamentos (cenário base e proposto). No horizonte da vida toda, os resultados para os pacientes iniciando com 12 anos de idade foi uma economia por paciente de R$ 1.342.233,18 e R$ 3.625.885,71 para os cenários base e proposto respectivamente. ANÁLISE DE IMPACTO ORÇAMENTÁRIO: Os resultados da análise de custo-efetividade foram utilizados para a construção da análise de impacto orçamentário. Dados do Perfil de Coagulopatias de 2016, do IBGE e do Painel Delphi foram utilizados para estimar o número de pacientes elegíveis ao tratamento. Estimou-se que de 30% a 40% dos pacientes teriam um perfil sangrador e seriam elegíveis a substituição pela formulação de liberação estendida (alfadamoctocogue pegol). Esses valores foram utilizados no market share proposto. Ao final de 5 anos, estimou-se uma economia de R$323.024.411,22. MONITORAMENTO DO HORIZONTE TECNOLÓGICO: Foram detectadas quatro tecnologias potenciais para o tratamento de pacientes com hemofilia a partir de 12 anos de idade. O Mim-8, um anticorpo IgG4 mimético do fator 8 de coagulação, que tem como alvos os fatores IX e X de coagulação, o fitusiran, um RNA silenciador (siRNA), direcionado ao RNA mensageiro (RNAm) codificador de antitrombina, e os anticorpos monoclonais IgG4 concizumabe e marstacimab, inibidores do inibidor da via do fator tissular (TFPI). Além dos potenciais medicamentos descritos, com mecanismos de ação diferentes dos fatores de coagulação, estão em fase 3 clínica os fatores VIII recombinantes FRSW-107, SCT-800 e efanesoctocog alfa (BIVV001). Além desses, foram registrados, em outros países, os fatores VIII recombinantes damoctocog alfa pegol (Japão, 2019); lonoctocog alfa (EUA, 2016) e turoctocog alfa pegol (Alemanha e Suíça, 2019). O alfadamoctocogue é protegido pela patente PI 0517795-2, depositada no Instituto Nacional da Propriedade Intelectual (INPI) em 14/11/2005, com validade até 31/03/30 (45). CONSIDERAÇÕES FINAIS: Não houve estudos de comparação direta que mostrasse que a intervenção é superior ou possui a mesma efetividade do comparador. Apenas um estudo de comparação indireta demonstrou não haver significância estatística entre as alternativas. A avaliação de custo-minimização e o impacto orçamentário mostraram resultados que representaram economia para o SUS com a incorporação da nova tecnologia. RECOMENDAÇÃO PRELIMINAR DA CONITEC: Diante do exposto, a Conitec, em sua 5ª reunião extraordinária, realizada no dia 12 de maio de 2021, deliberou que a matéria fosse disponibilizada em consulta pública com recomendação preliminar de todos os membros do plenário desfavorável à incorporação do alfadamoctocogue pegol para o tratamento de hemofilia A em profilaxia secundária para pacientes a partir de 12 anos de idade no SUS. Os membros do plenário concordaram que, apesar da comodidade posológica, diante da impossibilidade de desconto nos impostos, o impacto orçamentário que antes produziria uma economia, se torna um gasto próximo a 200 milhões de reais ao final de 5 anos. A matéria foi disponibilizada em consulta pública. CONSULTA PÚBLICA: Foram recebidas 3.387 contribuições, sendo 434 pelo formulário para contribuições técnico-científicas e 2.953 pelo formulário para contribuições sobre experiência ou opinião de pacientes, familiares, amigos ou cuidadores de pacientes, profissionais de saúde ou pessoas interessadas no tema. Das 434 contribuições de cunho técnico-científico recebidas, 66 foram analisadas, já que as demais não apresentaram informação alguma (em branco) ou argumentação técnica sobre as evidências. No total, 117 concordaram com a recomendação inicial da Conitec, 9 não concordaram e não discordaram e 308 discordaram. Das 117 que concordaram, 44 apresentaram algum comentário sobre essa opinião e todos eles discordavam da decisão da Conitec. Das 2.952 contribuições recebidas sobre experiência com a tecnologia ou opinião sobre o tema, 339 foram analisadas, já que as demais não apresentaram informação alguma (em branco). No total, 559 concordaram com a recomendação inicial da Conitec, 62 não concordaram e não discordaram e 2.331 discordaram. Os assuntos abordados pelos participantes que discordaram da recomendação preliminar foram majoritariamente relacionados ao acesso e a possibilidade de mais uma opção terapêutica, os ganhos em qualidade de vida e a comodidade posológica que a tecnologia traz aos pacientes. RECOMENDAÇÃO FINAL DA CONITEC: Pelo exposto, o Plenário da Conitec, em sua 101ª Reunião Ordinária, no dia primeiro de setembro de 2021, recomendou, por maioria simples, a incorporação de alfadamoctocogue pegol para a profilaxia secundária em pacientes com Hemofilia A, a partir de 12 anos, previamente tratados e sem inibidor no SUS, conforme Protocolo estabelecido pelo Ministério da Saúde. Considerou-se como justificativa para a decisão a maior vantagem posológica e a economia demonstrada ao SUS. Por fim, foi assinado o Registro de Deliberação nº 664/2021. DECISÃO: Incorporar o alfadamoctocogue pegol para profilaxia secundária em pacientes com Hemofilia A, no âmbito do Sistema Único de Saúde ­ SUS, conforme a Portaria nº 11, publicada no Diário Oficial da União nº 31, seção 1, página 71, em 14 de fevereiro de 2022.

Evaluation of efficacy and safety of endovascular coiling for patients with aneurysmal subarachnoid hemorrhage: A protocol for systematic review and meta-analysis.

BACKGROUND: There is an elevated risk of rebleeding when the aneurysm is left untreated in patients diagnosed with aneurysmal subarachnoid hemorrhage (SAH). Occlusion of the lumen of the aneurysm using endovascular coiling is a common method to prevent rebleeding by occluding the aneurysm. This study aims to evaluate the efficacy and safety of endovascular coiling in patients with aneurysmal SAH. METHODS: A systematic search for relevant articles will be performed in 4 English electronic databases, including MEDLINE (from 1966 to October 2020), EMBASE (from 1980 to October 2020), the Cochrane Library (from 2020, issue 10), Scopus (from 1823 to October 2020), and 3 Chinese electronic databases, including Chinese Biomedical Literature Database (from 1995 to October 2020), WanFang (last searched October 2020), and China National Knowledge Infrastructure (last searched October 2020). This study will comprise randomized controlled trials (RCTs) that evaluate the effectiveness and safety of using endovascular coiling in the treatment of aneurysmal SAH. The articles in the databases will be independently screened by 2 authors to select potential studies, extract data, and evaluate the bias risk in the selected studies. This study will use suitable statistical methods to merge result data. RESULTS: The results of this study will be useful in determining the efficacy and safety of endovascular coiling for treating patients with aneurysmal SAH. CONCLUSION: The findings of this study will summarize the most recent evidence on the effectiveness and safety of using endovascular coiling to treat aneurysmal SAH. ETHICS AND DISSEMINATION: The present work does not involve any humans or animals; therefore, ethical approval is not needed. SYSTEMATIC REVIEW REGISTRATION: December 2, 2020.osf.io/yj4gq (https://osf.io/yj4gq/).

Extracranial/Intracranial Vascular Bypass in the Treatment of Head and Neck Cancer - Related Carotid Blowout Syndrome.

OBJECTIVE/HYPOTHESIS: To investigate the endovascular intervention or extracranial/intracranial (EC/IC) vascular bypass in the management of patients with head and neck cancer-related carotid blowout syndrome (CBS). STUDY DESIGN: Retrospective case series. METHODS: Retrospective analysis of clinical data of patients with head and neck cancer-related CBS treated by endovascular intervention and/or EC/IC vascular bypass, analysis of its bleeding control, neurological complications, and survival results. RESULTS: Thrity-seven patients were included. Twenty-five were associated with external carotid artery (ECA); twelve were associated with internal or common carotid artery (ICA/CCA). All patients with ECA hemorrhage were treated with endovascular embolization. Of the 12 patients with ICA/CCA hemorrhage, 9 underwent EC/IC bypass, 1 underwent endovascular embolization, and 3 underwent endovascular stenting. For patients with ECA-related CBS, the median survival was 6 months, and the 90-day, 1-year, and 2-year survival rates were 67.1%, 44.7%, and 33.6%, respectively; the estimated rebleeding risk at 1-month, 6-month, and 2-year was 7.1%, 20.0%, and 31.6%, respectively. For patients with ICA/CCA-related CBS, the median survival was 22.5 months, and the 90-day, 1-year, and 2-year survival rates were 92.3%, 71.8%, and 41.0%, respectively; the estimated rebleeding risk at 1 month, 6 months, and 2 years is 7.7%,15.4%, and 15.4%, respectively. ICA/CCA-related CBS patients have significantly longer survival time and lower risk of rebleeding, which may be related to the more use of EC/IC vascular bypass as a definite treatment. CONCLUSIONS: For patients with ICA/CCA-related CBS, if there is more stable hemodynamics, longer expected survival, EC/IC vascular bypass is preferred. LEVEL OF EVIDENCE: 4 Laryngoscope, 131:1548-1556, 2021.

Elastic intramedullary nail treatment of adolescent perihardware radius and ulna refracture.

A 13-year-old girl presented to the clinic with a midshaft refracture of both forearm bones adjacent to the site of a prior forearm fracture that had been treated with plating. She was treated with hardware removal and placement of elastic intramedullary nails. Flexible intramedullary nailing can be successful for a skeletally mature adolescent in treatment of refracture surrounding plate fixation of a midshaft forearm fracture. This technique allows for additional protection of the entire length of the affected bones, while avoiding the extensive dissection needed for extended plating.

Pediatric Spontaneous Pneumothorax: Does Initial Treatment Affect Outcomes?

BACKGROUND: Primary spontaneous pneumothorax (PSP) commonly occurs in adolescents, most commonly in males, and has recurrence rates between 20% and 60%. Surgical therapy has long been debated regarding its role in preventing recurrence, with no current consensus on guidelines for care. The purpose of this study is to examine the effect of treatment type on recurrence rates in pediatric PSP. METHODS: This is a single-institution, institutional review board-approved retrospective analysis of patients aged 1 to 18 diagnosed with their first occurrence of PSP between 2009 and 2017. Patient demographics, hospital course, and outcomes over a 2-y period were collected. Patients were divided into nonoperative (oxygen therapy only) management, chest tube placement, and surgical management. The primary outcome was the recurrence rate. RESULTS: Sixty-four patients diagnosed with PSP met inclusive criteria. The mean age was 15.5, and 48 (75%) of patients were men. Twenty-one patients (33%) underwent nonoperative treatment, 24 patients (37.5%) underwent operative treatment with video-assisted thoracoscopic surgery or open thoracotomy, and 19 patients (30%) underwent chest tube or pigtail placement alone. Fifteen patients (23.4%) experienced a recurrence within 2 y: 6 patients (29%) from the nonoperative treatment group, 4 (21%) who were treated with the chest tube only, and 5 (21%) who underwent video-assisted thoracoscopic surgery or open thoracotomy. No statistically significant difference in recurrence rates was found between treatment groups. Pneumothorax size was found to differ between treatment type; larger pneumothoraces were more likely to undergo surgical intervention (P = 0.0003). Smaller pneumothoraces were associated with higher rates of recurrence on multivariate logistic regression analysis (P = 0.046). CONCLUSIONS: Recurrence of PSP in adolescents was found to be 23.4% after 2-y follow-up. Smaller-sized pneumothoraces were associated with higher rates of recurrence, but treatment type did not significantly affect recurrence rates.

Chronic mesenteric ischemia: Clinical practice guidelines from the Society for Vascular Surgery.

BACKGROUND: Chronic mesenteric ischemia (CMI) results from the inability to achieve adequate postprandial intestinal blood flow, usually from atherosclerotic occlusive disease at the origins of the mesenteric vessels. Patients typically present with postprandial pain, food fear, and weight loss, although they can present with acute mesenteric ischemia and bowel infarction. The diagnosis requires a combination of the appropriate clinical symptoms and significant mesenteric artery occlusive disease, although it is often delayed given the spectrum of gastrointestinal disorders associated with abdominal pain and weight loss. The treatment goals include relieving the presenting symptoms, preventing progression to acute mesenteric ischemia, and improving overall quality of life. These practice guidelines were developed to provide the best possible evidence for the diagnosis and treatment of patients with CMI from atherosclerosis. METHODS: The Society for Vascular Surgery established a committee composed of vascular surgeons and individuals experienced with evidence-based reviews. The committee focused on six specific areas, including the diagnostic evaluation, indications for treatment, choice of treatment, perioperative evaluation, endovascular/open revascularization, and surveillance/remediation. A formal systematic review was performed by the evidence team to identify the optimal technique for revascularization. Specific practice recommendations were developed using the Grading of Recommendations Assessment, Development, and Evaluation system based on review of literature, the strength of the data, and consensus. RESULTS: Patients with symptoms consistent with CMI should undergo an expedited workup, including a computed tomography arteriogram, to exclude other potential causes. The diagnosis is supported by significant arterial occlusive disease in the mesenteric vessels, particularly the superior mesenteric artery. Treatment requires revascularization with the primary target being the superior mesenteric artery. Endovascular revascularization with a balloon-expandable covered intraluminal stent is the recommended initial treatment with open repair reserved for select younger patients and those who are not endovascular candidates. Long-term follow-up and surveillance are recommended after revascularization and for asymptomatic patients with severe mesenteric occlusive disease. Patient with recurrent symptoms after revascularization owing to recurrent stenoses should be treated with an endovascular-first approach, similar to the de novo lesion. CONCLUSIONS: These practice guidelines were developed based on the best available evidence. They should help to optimize the care of patients with CMI. Multiple areas for future research were identified.

Vicryl Mesh Coverage Reduced Recurrence After Bullectomy for Primary Spontaneous Pneumothorax.

BACKGROUND: Although thoracoscopic stapled bullectomy is a standard procedure for primary spontaneous pneumothorax (PSP), the postoperative recurrence rate is high. We investigated whether using a Vicryl (Ethicon, Somerville, NJ) mesh to cover the staple line after bullectomy reduces the postoperative recurrence rate. METHODS: Our single-blind, parallel-group, prospective, randomized controlled trial at 2 medical centers in Taiwan studied patients with PSP who were aged 15 to 50 years and required thoracoscopic bullectomy. On the day of operation, patients were randomly assigned (1:1) to receive Vicryl mesh (mesh group) or not (control group) after thoracoscopic bullectomy with linear stapling and mechanical apical pleural abrasion. Randomization was achieved using computer-generated random numbers in sealed envelopes. Our primary end point was the pneumothorax recurrence rate within 1 year after the operation (clinicaltrials.gov number, NCT01848860.) RESULTS: Between June 2013 and March 2016, 102 patients were assigned to the mesh group and 102 to the control group. Within 1 year after operation, recurrent pneumothorax was diagnosed in 3 patients (2.9%) in the mesh group compared with 16 (15.7%) in the control group (P = .005). The short-term postoperative results and hospitalization duration were comparable between the groups. CONCLUSIONS: For thoracoscopic bullectomy with linear stapling and mechanical apical pleural abrasion, the use of a Vicryl mesh to cover the staple line is effective for reducing the postoperative recurrence of pneumothorax. Vicryl mesh coverage can be considered an optimal adjunct to the standard surgical procedure for PSP.

Percutaneous transhepatic portal vein stenting as rescue treatment for recurrent oesophageal variceal bleeding in a 31-year-old woman with haepatocellular carcinoma in a non-cirrhotic liver.

A 31-year-old woman with hepatocellular carcinoma suffered from recurrent oesophageal variceal bleeding due to portal hypertension, which was caused by severe compression of the portal vein by metastatic lymph nodes. Endoscopic band ligation and pharmacological treatment did not suffice to prevent recurrence of variceal bleeding. Eventually, after the fifth variceal bleeding within 6 months, the patient was admitted to the intensive care unit in a haemodynamic shock. A Sengstaken-Blakemore tube was inserted and all treatment options were discussed, but only percutaneous transhepatic recanalisation of the portal vein with stent placement to reduce portal vein pressure was thought to be feasible with any chance to relieve portal vein pressure. After successful portal vein stenting, our patient did not have any recurrent bleeding in the remaining year of her life. We suggest that percutaneous transhepatic portal vein stenting may be a feasible and adequate last line treatment for complications of portal hypertension.

Treatment of Refractory Melasma in Asians With the Picosecond Alexandrite Laser.

BACKGROUND/OBJECTIVES: The picosecond Alexandrite laser was studied in our practice with the diffractive lens array and the flat optic to treat melasma. METHODS AND MATERIALS: Sixty patients with melasma were treated in a prospective investigation with the picosecond Alexandrite laser. Nineteen patients were treated with the flat optic and 41 patients were treated with the diffractive lens array. Treatments were performed with 1 pass at 2-week intervals for 6 treatments. The Melasma Severity Index (MSI) was used to evaluate the patients before treatment and 3 and 6 months after the final treatment session. RESULTS: At 6 months after the last treatment, there was an 18.5% difference between the groups with a 75.7% improvement in the MSI in patients with the diffractive lens array and a 57.2% improvement in the MSI score in patients with the flat optic. At 6 months, there was recurrence of melasma in 5% of the cases with no hyperpigmentation with the diffractive optic in contrast to recurrence in 16% of the cases in the flat optic group and a transient macular hyperpigmentation in 21% of the cases. CONCLUSION: This investigation highlights the utility of a picosecond Alexandrite laser with a flat and diffractive lens to successfully treat a large percentage of Asian patients in a sunny climate.

No-Touch Technique of Mesh Placement in Ventral Hernia Repair: Minimizing Postoperative Mesh Infections.

Synthetic mesh is commonly used in ventral hernia repairs to reinforce the abdominal closure and minimize hernia recurrence rates. However, the use of synthetic mesh is associated with certain risks, most notably infection requiring explantation. This study sought to evaluate the use of a "no-touch" technique with antibiotic solution during synthetic mesh placement in ventral hernia repairs and its impact on complication/infection rates. The authors retrospectively reviewed a prospectively maintained database of patients undergoing abdominal wall reconstruction with synthetic mesh from 2013 to 2018 by a single surgeon with a minimum 1-year follow-up. Data collected included demographic data, medical comorbidities, hernia history, and the type of antibiotics used in the no-touch technique. Complications were stratified into short-term (<30 days), medium-term (30 to 90 days), and long-term (91 to 365 days) complications. Results were compared to previously published rates in the literature. Eighty-eight patients met inclusion criteria. Fourteen patients (15.9 percent) experienced postoperative complications (two patients had multiple complications); six of these patients (6.8 percent) were readmitted to the hospital for management. Subsequently, three of the readmitted patients (3.4 percent) required reoperations related to abdominal infection and required removal of the synthetic mesh. A total of 16 complication events occurred in the cohort: 13 short-term complications (81.3 percent), three medium-term complications (18.7 percent), and zero long-term complications. The authors conclude that the no-touch technique for mesh placement in ventral hernia repairs appears to be efficacious in minimizing infectious complications with mesh placement, although further prospective studies are required to further define this relationship. CLINICAL QUESTION/LEVEL OF EVIDENCE:: Therapeutic, IV.

Preventing the recurrence of acute anorectal abscesses utilizing a loose seton: a pilot study.

INTRODUCTION: This pilot study aimed to document our results of treating anorectal abscesses with drainage plus loose seton for possible coexisting high fistulas or drainage plus fistulotomy for low tracts at the same operation. METHODS: Drainage plus fistulotomy were performed only in cases with subcutaneous mucosa, intersphincteric, or apparently low transsphincteric fistula tracts. For all other cases with high transsphincteric fistula or those with questionable sphincter involvement, a loose seton was placed through the tract. Drainage only was carried out in 17 patients. RESULTS: Twenty-three patients underwent drainage plus loose seton. Drainage plus fistulotomy were performed in four cases. None of the patients developed recurrent abscess during a follow-up of 12 months. Not surprisingly, the incontinence scores were similar pre and post-operatively (p=0.564). Only minor complications occurred in 4 cases (14.8 percent). Secondary interventions following loose seton were carried out in 13 patients (48.1 percent). At 12 months, drainage only was followed by 10 recurrences (58.8 percent; p<0.0001, compared with concomitant surgery). CONCLUSION: Concomitant loose seton treatment of high fistula tracts associated with anorectal abscess prevents abscess recurrence without significant complications or disturbance of continence. Concomitant fistulotomy for associated low fistulas also aids in the same clinical outcome. Concomitant fistula treatment with the loose seton may suffice in treating the whole disease process in selected cases. Even in patients with high fistula tracts, the loose seton makes fistula surgery simpler with a mature tract. Abscess recurrence is high after drainage only.

Normalization of Forefoot Supination After Tibialis Anterior Tendon Transfer for Dynamic Clubfoot Recurrence.

BACKGROUND: We aimed to evaluate the effect of tibialis anterior tendon transfer (TATT) on foot motion in children with clubfoot recurrence after initial Ponseti treatment. METHODS: Children with dynamic clubfoot recurrence after initial Ponseti treatment who underwent TATT between 2014 and 2017 were considered for inclusion. Exclusion criteria were neurological disease, split transfer of the tendon, additional bone or joint invasive surgery, and initial treatment abroad. Of 94 children (143 TATT), 36 met the inclusion criteria. Seventeen (47%) of the 36 children with 25 clubfeet and a mean age at the time of surgery of 6.8 years participated in the study. Gait analysis, including the Oxford foot model, was conducted preoperatively and postoperatively. Furthermore, kinematic and kinetic data were compared with those of age-matched healthy children (n=18). RESULTS: Forefoot supination in relation to the hindfoot and tibia was reduced during swing and at initial contact after TATT compared with preoperative values. Forefoot supination in relation to the tibia at initial contact decreased from 12.4 to 5.2 degrees after TATT (control group, 6.0 degrees). The heel showed less dynamic varus and adduction movement after TATT compared with preoperatively. Maximum ankle power was reduced preoperatively and postoperatively compared with controls. Maximum ankle dorsiflexion slightly increased after TATT. CONCLUSIONS: Gait analysis showed normalization of the main components of dynamic clubfoot recurrence after TATT. This joint-sparing surgery efficiently corrects recurrent dynamic deformity. LEVEL OF EVIDENCE: Level II-therapeutic.

Mobile health application platform 'Corrie' personalises and empowers the heart attack recovery patient experience in the hospital and at home for an underserved heart attack survivor.

Cardiovascular disease (CVD) is the leading cause of morbidity and mortality worldwide with an estimated 17.5 million deaths annually, according to the World Health Organization (WHO). CVD prevention efforts have the potential to prevent the majority of these deaths by supporting guideline-directed medical therapy (GDMT) and lifestyle modification. Mobile health (mHealth) has the potential to address this gap, but has limited evaluation in clinical studies to date. We present the case of a middle-aged patient of low socioeconomic status, with multiple comorbidities, and no prior smartphone experience, who suffered an acute myocardial infarction (MI) and was given the Corrie intervention while hospitalised. The patient demonstrated improvement in lifestyle modification, adherence to GDMT and post-MI recovery through 2.4 years follow-up. This case supports (1) the potential of mHealth interventions to enhance patient experience and outcomes, (2) intuitive design for adoption and improvement in end user experience and (3) the capability of mHealth to reach and empower underserved patients.

Smartphone-based secondary prevention intervention for university students with unhealthy alcohol use identified by screening: study protocol of a parallel group randomized controlled trial.

BACKGROUND: Unhealthy alcohol use is a leading cause of morbidity and mortality among young people, including university students. Delivering secondary prevention interventions against unhealthy alcohol use is challenging. Information technology has the potential to reach large parts of the general population. The present study is proposed to test a proactive secondary prevention smartphone-based intervention against unhealthy alcohol use. METHODS: This is a parallel-group, randomized controlled trial (1:1 allocation ratio) among 1696 university students with unhealthy alcohol use, identified by screening and followed up at 3, 6, and 12 months. Participants will be randomized to receive access to a smartphone-based intervention or to a no intervention control condition. The primary outcome will be self-reported volume of alcohol drunk over the past 30 days, reported as the mean number of standard drinks per week over the past 30 days, measured at 6 months. Secondary outcomes will be number of heavy drinking days over the past 30 days, at 6 months. Additional outcomes will be maximum number of drinks on any day over the past 30 days, alcohol-related consequences (measured using the Short Inventory of Problems (SIP-2R), and academic performance. DISCUSSION: The aim of this trial is to close the evidence gap on the efficacy of smartphone-based secondary prevention interventions. If proven effective, smartphone-based interventions have the potential to reach a large portion of the population, completing what is available on the Internet. TRIAL REGISTRATION: ISRCTN, 10007691. Registered on 2 December 2019. Recruitment will start in April 2020.

ICD implantation for secondary prevention in patients with ventricular arrhythmia in the setting of acute cardiac ischemia and a history of myocardial infarction.

INTRODUCTION: In patients with a prior myocardial infarction (MI) but preserved left ventricular (LV) function, sustained ventricular arrhythmias (VAs) may arise in the setting of an acute coronary syndrome (ACS). It is unknown whether an implantable cardioverter-defibrillator (ICD) is mandatory in these patients as VA might be triggered by a reversible cause. The purpose of this study is to analyze the benefit of ICD therapy in this patient population. METHODS: We conducted a retrospective observational study in ICD recipients implanted from 2008 to 2011. The study group consisted of patients with sustained VA in the setting of an ACS, with a history of MI, but with left ventricular ejection fraction (LVEF) greater than 35 (group A). The two control groups consisted of patients admitted with VA with a history of MI, but without ACS at presentation, either with LVEF greater than 35% (group B) or ≤35% (group C). The primary endpoint was the number of patients with appropriate ICD therapy (antitachycardia pacing or shock). RESULTS: A total of 291 patients were included with a mean follow-up of 5.3 years. Appropriate ICD therapy occurred in 45.6% of the patients in group A vs 51.6% and 60.4% in groups B and C (P = .11). In group A, 31.1% received an appropriate ICD shock vs 34.7% and 44.3% in control groups B and C (P = .12). CONCLUSION: On the basis of these data, ICD implantation seems warranted in patients with history of MI presenting with VA in the setting of an ACS, despite preserved LV function and adequate revascularization. Further trials, preferably randomizes, should be performed to address these findings.

Biomechanical Features of Reinforced Esophageal Hiatus Repair in a Porcine Model.

Recurrence rates in the laparoscopic repair of the hiatal hernia range from 12% to 59%. Limitation of reinforcement has been principally the risk of adverse events caused by synthetic materials. Biologic and resorbable synthetic materials are valid alternatives. This study compares the host response to all these materials after hiatal hernia repair. A total of 20 Landrace pigs, underwent laparoscopic primary hiatal hernia repair and reinforced with a polypropylene mesh (PROLENE: polypropylene [PP]), an absorbable synthetic scaffold (GOREBIO-A: polyglycolic acid [PGA]), a urinary bladder matrix scaffold, (Gentrix: urinary bladder matrix [UBM]), or without reinforcement, control group (C). Animals were survived for 3 months. Endpoints included gross morphology, biomechanical testing, and histology. Pigs in PP and PGA groups showed fibrosis at the repair site, with robust adhesions. In UBM and C groups, only mild adhesions were found. Load at failure (gr) and stiffness (gr/mm) of PP were higher than C group (PP:2103 ± 548.3 versus C:951.1 ± 372.7, P = 0.02; PP:643.3 ± 301 versus C:152.6 ± 142.7, P = 0.01). PGA and UBM values for both parameters were in between PP and C samples. However, stiffness in UBM was tended to be lower than PP group, and approached a significant difference (643.3 ± 301 versus 243 ± 122.1, P = 0.0536). In UBM group, the histology resembled native tissue. By contrast, PP and PGA groups showed mononuclear infiltrates, fibroencapsulation, necrosis, remnants of mesh, and disorganized tissue that was validated with a histologic score. In this setting, UBM scaffolds showed the most appropriate features for hiatal hernia repair, recovering the tissue properties that can help reduce the possibility of early failure and prevent complications associated with the implanted material.

Minimising recurrence after primary femoral hernia repair; is mesh mandatory?

PURPOSE: The recent international hernia guidelines advocate laparoscopic pre-peritoneal mesh repair for primary femoral hernias. However, no randomised trial has demonstrated a lower recurrence rate compared to suture repair. This study aimed to determine the 5-year recurrence rate following femoral hernia repair, in elective and emergency settings, according to surgical approach (open or laparoscopic) and method (suture, suture + mesh, or mesh alone). METHODS: Consecutive patients undergoing primary femoral hernia repairs within a single health board, between 2007 and 2013, were identified from a prospective audit. Patients who had died or were uncontactable during the period of follow-up were excluded. Recurrence was defined as the clinical suspicion of an ipsilateral groin hernia at outpatient review or patient reported ipsilateral groin swelling. RESULTS: A total of 297 patients underwent primary femoral hernia repairs in the time period. Of the 138 cases with complete follow-up, 25 patients experienced recurrence at 5 years (18%), with 60% of recurrences evident within the first post-operative year. The median follow-up of the remaining 113 patients was 93 months (range 63-127). No difference could be detected in recurrence rates (P = 0.372, P = 0.353), or time to recurrence (P = 0.421, P = 0.295), according to repair type (suture only, suture and mesh, or mesh only) or surgical approach (high open, low open and laparoscopic pre-peritoneal), respectively. CONCLUSIONS: Use of different surgical approaches and types of repair for primary presentations of femoral hernia did not affect the recurrence rate or time to recurrence. Use of a pre-peritoneal mesh did not alter the recurrence rate or recurrence free survival, in either elective or emergency settings, compared to simple suture repair. Recurrence following primary femoral hernia repair tends to occur within the first post-operative year, suggesting that technical factors may be as important as suture or mesh failure.