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BACKGROUND: The expansion of the transcatheter aortic valve replacement (TAVR) indication towards patients with intermediate surgical risk (Ref. Society of Thoracic Surgeons, STS, score) was analyzed. The aim was to investigate if the complication rates particularly with respect to TAVR and surgical aortic valve replacement (SAVR) concerning patients with intermediate risk are comparable. METHODS: An analysis of serious adverse events (SAEs) and complication rates in clinical trials with TAVR and SAVR of these patients in comparison with high surgical risk patients was performed with the scientific literature and in the Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM) database (2012-2017). RESULTS: In several studies for intermediate-risk TAVR patients the published data showed that some complication rates (e.â¯g. mortality) are comparable or better than for intermediate-risk SAVR patients. The analysis of the BfArM database in study 1 (TAVR) resulted in a lower all-cause mortality for intermediate-risk patients (0.9% at 30 days and 7.3% at 1 year post-procedure) than concerning high-risk patients (5.2% at 30 days and 15.7% at 1 year post-procedure). In study 1 the cardiovascular mortality was altogether 11.5% at 4 years post-procedure (9.2% for intermediate and 13.4% for high-risk patients), in study 2 (patients with high-risk) at 4 years it was 15.5% in the TAVR group with slightly lower cardiovascular mortality for SAVR patients with 14.8%. CONCLUSION: In the analysis TAVR interventions have favorable incidences concerning mortality (all-cause and cardiovascular) for intermediate-risk patients. Recently, a transcatheter aortic heart valve with this expanded risk indication received a CE label for the first time in Europe; however, the results of larger clinical studies are relevant for the evaluation (e.â¯g. long-term function over more than 5 years) of TAVR valves for intermediate-risk patients.
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Estenose da Valva Aórtica , Implante de Prótese de Valva Cardíaca , Substituição da Valva Aórtica Transcateter , Valva Aórtica , Ensaios Clínicos como Assunto , Europa (Continente) , Implante de Prótese de Valva Cardíaca/efeitos adversos , Humanos , Estudos Retrospectivos , Substituição da Valva Aórtica Transcateter/efeitos adversos , Resultado do TratamentoRESUMO
INTRODUCTION: Vascular alterations such as arterial lesions themselves or caused by injuries (external site) occur only rarely in children and adolescents. By means of a narrative review including our own clinical experience and a representative case report, vascular alterations in children and adolescents are discussed. Complex Patient- & clinical Finding-associated Aspects: - Dissections of vertebrocerebral arterial branches: usually, the aetiopathogenesis reveals external factors or primary alterations of the vascular wall. The therapeutic approach comprises anticoagulation or surgical, sometimes endovascular intervention in cases of recurrent ischaemic symptoms. - Aneurysm of the carotid artery: the therapeutic approach is characterised by surgical and interventional treatment according to the individual case-specific finding, alternatives in vascular reconstruction can be derived from the classification by de Jong et al. Representative Case Report: An 11 year old boy was diagnosed with intracranial dissection of the left vertebral artery initially treated with anticoagulation (6 months) and a consecutive neurosurgical approach (trepanation and coverage of the dissecting aneurysm) and, subsequently (within the 16th year of age), he underwent interventional treatment (coil embolisation) because of an expansion of the aneurysm. In addition, an aneurysm of the right internal carotid artery was found, which was approached surgically with interposition of a vena-saphena-magna segment. CONCLUSION: Vascular alterations such as dissections and aneurysms of vertebrocerebral arterial branches in children and adolescents are challenging. Dissections should be treated with anticoagulation. In the case of recurrent ischaemic symptoms or in cases of pressure phenomenon including neurological alterations, interventional or surgical treatment is indicated. In the case of an aneurysm of the carotid artery, there is an indication for surgical treatment: In children and teenagers, venous segments for interposition and single-stitch sutures are usually used. Competent decision-making for treatment and periinterventional management require appropriate interdisciplinary expertise.
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Aneurisma/diagnóstico , Aneurisma/terapia , Doenças das Artérias Carótidas/diagnóstico , Doenças das Artérias Carótidas/terapia , Dissecação da Artéria Vertebral/diagnóstico , Dissecação da Artéria Vertebral/terapia , Adolescente , Aneurisma/epidemiologia , Aneurisma/etiologia , Angiografia Digital , Doenças das Artérias Carótidas/epidemiologia , Doenças das Artérias Carótidas/etiologia , Dissecação da Artéria Carótida Interna/diagnóstico , Dissecação da Artéria Carótida Interna/epidemiologia , Dissecação da Artéria Carótida Interna/etiologia , Dissecação da Artéria Carótida Interna/terapia , Angiografia Cerebral , Criança , Estudos Transversais , Embolização Terapêutica , Humanos , Aneurisma Intracraniano/diagnóstico , Aneurisma Intracraniano/epidemiologia , Aneurisma Intracraniano/etiologia , Aneurisma Intracraniano/terapia , Fatores de Risco , Veias/transplante , Dissecação da Artéria Vertebral/epidemiologia , Dissecação da Artéria Vertebral/etiologiaRESUMO
AIM: The aim of this work is to illustrate the diversity of vascular injuries in terms of vascular segments or body regions, accident mechanisms and specific patient constellations. METHOD: A representative case collection was compiled based on current and relevant scientific references in PubMed, own clinical experiences, vascular surgical and novel image-guided interventional options. RESULTS: The diagnostics of vascular injuries in the context of trauma and fractures are based on a thorough physical examination. In addition, the hard and soft signs preferred by the Western Trauma Association should be included in the decision. Doppler ultrasonography examination is the safest and gentlest noninvasive examination procedure for a suspected vascular injury due to repeatable and comparative measurements. The stabilization of a fracture, ideally using an external fixator, should be performed before vascular reconstruction whenever possible, unless massive bleeding, hypovolemic shock or a rapidly spreading hematoma represent an immediate indication for surgery. In pediatric supracondylar fractures, avascular injury without relevant ischemia has frequently been described (pink pulseless hand). In this case, the fracture should first be reduced as the pulse often recovers. Due to the increasing availability, good technical handling and high technical success rate as well as the relatively limited interventional trauma, endovascular treatment of traumatic vascular injuries has become widely accepted. Traumatic aortic ruptures are associated with a high mortality even at the accident site. Rapid endovascular treatment using a stent prosthesis significantly increases the injured person's chances of survival. CONCLUSION: Vascular injuries in connection with fractures or multiple injuries require interdisciplinary cooperation between the specialties involved.
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INTRODUCTION: An increasing shortage of specialists and training assistants is also being lamented in vascular surgery. Despite a continuous increase in the number of physicians and medical students in Germany in recent years, the need for specialists and training assistants in vascular surgery is enormous in a sustained manner. METHODS: Professional policy analysis from a medical vascular surgery perspective including currently available statistics, especially from the Federal Statistical Office, the Federal Medical Association, the Saxony-Anhalt (SA) State Medical Association and selective references from current medical scientific literature on epidemiological topics. RESULTS: In 2022, according to the basic data of the Federal Statistical Office 200 vascular surgery departments provided a total of 5706 beds for care. In 2021, 1574 physicians with the regional and specialist title in vascular surgery were registered by the medical associations. In the following years, there was an increase of 404 vascular surgeons. The recognition of the specialist title for vascular surgery fell from 166 in 2018 to 143 in 2021. There are 23 vascular surgery care units in Saxony-Anhalt (SA). At the SA Medical Association, there were 52 registered doctors with the specialist title in vascular surgery in the inpatient sector in 2021. In comparison, at the North Rhine Medical Association in 2021 there were 362 registered doctors with regional and specialist titles in vascular surgery overall and 292 in the inpatient sector. The age-standardized hospital incidence of peripheral arterial occlusive disease (PAOD) rose from approximately 190 to over 250 per 100,000 inhabitants in Germany between 2005 and 2016 and plateaued at this level. This corresponded to a relative increase of 33%. During the same observational period, the number of procedures performed doubled, mainly due to a strong increase in the number of endovascular interventions (approximately 140% increase) and interventions for arterial embolism/thrombosis (approximately +â¯80%). A research report commissioned by the German Hospital Society (DKG) in 2010 predicted a replacement requirement for physicians of approximately 108,000 by 2019 and an additional requirement of almost 31,000 physicians. While 14.6-27.2% of those employed in 2008 will have retired by 2020, between 45.6% and 68.5% will retire by 2030. Despite the statistically verifiable improvement in the staffing situation of specialists in vascular surgery in the inpatient and outpatient sectors in Germany, it can be assumed that there is a problem in recruiting young specialists. In order to target the recruitment of junior staff, it is first necessary to comprehensively record basic data on the staff situation and staff development in the area of residents in vascular surgery. In addition, further work should be done on implementing the recommendations for action already put forward years ago by scientific reports at state and federal levels.
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Especialidades Cirúrgicas , Cirurgiões , Humanos , Alemanha , Recursos Humanos , Procedimentos Cirúrgicos VascularesRESUMO
AIM: The aim of the manuscript is to discuss and assess the implications and opportunities as well as dangers of "outpatientization" of surgical and inpatient services for general and abdominal surgery. METHOD: Narrative overview with literature reference based on a PubMed search with the search terms: outpatient operations and inpatient interventions, AOP catalog, hybrid DRG, outpatient hernia surgery, outpatient proctological surgery, selective sector-equal reimbursement and day-care forms of care. RESULTS (KEY POINTS): - In the Anglo-American area, the treatment of inguinal hernias is predominantly carried out on an outpatient clinic basis. In the USA, Sweden and Denmark, for example, over 70% of all hernias are treated in an outpatient clinic setting, in Germany it is only 20%. In Germany, the catalog of operations that can be performed on an outpatient basis and other department-replacing interventions in hospitals defines outpatient interventions in accordance with § 115b Social Security Code (SGB) V (Germany). - The conversion from inpatient to outpatient hernia surgery has also failed so far due to an enormous difference in revenues. According to the will of the Federal Ministry of Health, the planned forms of semistationary care are intended to relieve the nursing staff in the hospitals and thus relieve the tense situation of nursing professionals. By the end of March 2023, a special industry-specific reimbursement, so-called hybrid DRGs, is to be agreed, which applies regardless of whether a paid service is provided on an outpatient or inpatient basis. - According to § 115b SGB V, whether a hernia can be performed under inpatient or outpatient conditions is also decided according to the location of the hernia. In the new AOP catalog, frailty is operationalized in the context factors via the degree of care and the Barthel index. If one compares the number of encryption procedures for the 5530 procedure (closure of an inguinal hernia) in 2005 (184,679) with the pre-corona year 2019 (179,851), it can be seen that the proportion of hernias treated in hospital remained approximately the same over a period of 14 years. - Most elective proctological procedures can be performed on an outpatient basis. For reasons of safety (bleeding) and practicality (pain management, dressing change of large abscesses), inpatient surgery is preferred: extensive hemorrhoidectomy in the case of massive findings, large abscesses, extensive perianal fistula corrections, particularly high transsphincteric or suprasphincteric fistulas. - Guidelines based on the British Guidelines for Ambulant Surgery should be required for comprehensive outpatient treatment in surgery. The introduction of corresponding hybrid DRGs seems to be the right way to cover the costs of outpatient surgery in hospitals. CONCLUSION: The restructuring of the hospital landscape and the nationwide expansion of outpatient operations is an unavoidable requirement in view of rising costs in the healthcare system and impending financing bottlenecks, which will pose challenges for the surgical disciplines in the years to come. Outpatient surgery is already practiced in many areas but has not become established due to the different remuneration. The flat rates for the same branches can be a starting point here. Furthermore, evidence-based framework conditions must be created along the lines of the British Guidelines for Ambulant Surgery.
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Procedimentos Cirúrgicos Ambulatórios , Hérnia Inguinal , Humanos , Abscesso , Pacientes Ambulatoriais , Hospitais , Hérnia Inguinal/cirurgiaRESUMO
INTRODUCTION: A material-associated true aneurysm after previous use of a vascular prosthesis for arterial reconstruction mostly in peripheral arterial occlusion disease (PAOD) is considered a rare but serious complication. AIM AND METHOD: The aim of the compact brief review was to describe the rare finding of a true aneurysm of a prosthesis and its diagnosis-specific care including a representative scientific case report, based on selected topic-related references from the medical literature as well as the specific experiences obtained from the successful clinical management in single cases. RESULTS (COMPLEX KEY POINTS ASSOCIATED WITH PATIENT AND CLINICAL FINDINGS AND CASE PRESENTATION): Out of initially 321 references found in the literature search, 20 articles published after 1995 were finally evaluated. Most frequently, pseudoaneurysms of knitted polyester prostheses at the femoropopliteal segment occurred on average after approximately 12.9 years. In one third of the cases two or more aneurysms of Dacron prostheses were described. Histological and electron microscopy investigations revealed mainly breakage of filaments and foreign body reactions. In more than half of the patients, the aneurysm was resected and for reconstruction an interposition graft was implanted. Complete removal of the prosthesis and endovascular treatment were only second choice. REPRESENTATIVE CASE: A 49-year-old male patient underwent a femoropopliteal P1 prosthetic bypass of the right leg in 1997. After 19 years a true aneurysm of the prosthesis was diagnosed in the right thigh using duplex ultrasonography and complementary magnetic resonance angiography (MRA). This was successfully treated with resection of the aneurysm and insertion of an 8mm Dacron prosthesis (Intergard Synergy Knitted, InterVascular, Bensheim, Germany). CONCLUSION: The development of true aneurysms of prostheses has not yet been satisfactorily clarified. This belongs to the profile of late complications, even if rarely and should be controlled after a postoperative interval of approximately one decade. This should be carried out by diagnostic imaging follow-up screening if the previous arterial recanalization/reconstruction could not be performed sequentially following endovascular intervention and venous-based reconstruction, other than with prosthetic material.
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Aneurisma , Prótese Vascular , Humanos , Masculino , Pessoa de Meia-Idade , Aneurisma/etiologia , Aneurisma/cirurgia , Prótese Vascular/efeitos adversos , Artéria Femoral , Alemanha , Polietilenotereftalatos , Revisões Sistemáticas como AssuntoRESUMO
BACKGROUND: Familial primary pulmonary hypertension (PPH) is an autosomal-dominant inherited disease with incomplete penetrance and poor prognosis. This study was performed to examine whether asymptomatic carriers of a mutated PPH gene can be identified at an early stage by their pulmonary artery systolic pressure (PASP) response to exercise. METHODS AND RESULTS: Stress Doppler echocardiography during supine bicycle exercise and genetic linkage analysis were performed on 52 members of 2 families with PPH. In 4 PPH patients, the mean PASP was increased at rest (73+/-16 mm Hg). Fourteen additional family members with normal PASP at rest revealed an abnormal PASP response to exercise (from 23+/-4 to 56+/-11 mm Hg) without secondary cause (abnormal response [AR] group). Twenty-seven other members (NR group) revealed a normal PASP response (maximal pressure <40 mm Hg) to exercise (from 24+/-4 to 37+/-3 mm Hg, P<0. 0001). All 14 AR but only 2 NR members shared the risk haplotype with the PPH patients. The molecular genetic analysis supported linkage to chromosome 2q31-32 with a logarithm of the odds score of 4.4 when the 4 patients and the 14 AR members were classified as affected. CONCLUSIONS: We conclude that the pathological rise of PASP in asymptomatic family members is linked to chromosome 2q31-32 and is probably an early sign of PPH. Therefore, stress Doppler echocardiography may be a useful tool to identify persons at risk for PPH even before pulmonary artery pressures at rest are elevated.
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Hipertensão Pulmonar/genética , Pressão Propulsora Pulmonar/fisiologia , Adolescente , Adulto , Idoso , Criança , Ecocardiografia Doppler , Exercício Físico/fisiologia , Feminino , Haplótipos , Heterozigoto , Humanos , Masculino , Pessoa de Meia-Idade , LinhagemRESUMO
PURPOSE: To evaluate the effect of irrigation solution and temperature on pupil diameter, corneal endothelium, and corneal pachymetry during and after phacoemulsification. SETTING: Klinik Dardenne, Bonn, Germany. METHODS: Eighty patients who had cataract surgery by phacoemulsification were assigned to 1 of 4 cross-classified groups and had intraoperative irrigation with room-temperature or refrigerated fortified balanced salt solution (BSS Plus) or modified Ringer's solution. Pupil diameters were recorded at different stages during the surgery. Epithelial cell counts and pachymetry were determined before and 1 day after surgery. RESULTS: The solution temperature did not affect any parameter. The type of solution did not influence endothelial cell loss; however, the solution had a significant effect on corneal pachymetry 1 day postoperatively. The corneas irrigated with BSS Plus were less swollen than the corneas irrigated with Ringer's solution. By day 14, corneal thickness was equal among all groups. CONCLUSION: Long-term results were equally favorable in all 4 groups. However BSS Plus induced less short-term corneal swelling than Ringer's solution. From these findings, it appears that BSS Plus may decrease corneal risk in cases with compromised corneas or prolonged surgery.
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Bicarbonatos/administração & dosagem , Temperatura Baixa , Substância Própria/efeitos dos fármacos , Endotélio Corneano/efeitos dos fármacos , Glutationa/administração & dosagem , Soluções Isotônicas/administração & dosagem , Facoemulsificação , Pupila/efeitos dos fármacos , Adulto , Idoso , Idoso de 80 Anos ou mais , Contagem de Células , Doenças da Córnea/prevenção & controle , Substância Própria/citologia , Combinação de Medicamentos , Endotélio Corneano/citologia , Feminino , Humanos , Período Intraoperatório , Implante de Lente Intraocular , Masculino , Pessoa de Meia-Idade , Soluções Oftálmicas , Complicações Pós-Operatórias/prevenção & controle , Solução de Ringer , Segurança , Irrigação Terapêutica , Resultado do TratamentoRESUMO
BACKGROUND: The study was initiated to evaluate the risks of surgical staplers. METHODS: In the years 2002-2007, a total of 165 reports of incidents or corrective actions from 3 manufacturers were registered and retrospectively analyzed with respect to the prevalent product default appearance, the results of the manufacturer's investigations and the severity of the consequences for patient. RESULTS: Severe patient consequences occurred in only 35.2%. In the majority of the cases no patient injury resulted from the reported malfunction and the investigations revealed no product error (52.7%). CONCLUSION: The surgical staplers are predominantly safe for application in thoracic and abdominal surgery. The incident reports are important for risk assessment and improvement of the surgical staplers.
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Análise de Falha de Equipamento/métodos , Complicações Pós-Operatórias/etiologia , Grampeadores Cirúrgicos/efeitos adversos , Anastomose Cirúrgica , Carcinoma Broncogênico/cirurgia , Estudos Transversais , Desenho de Equipamento , Análise de Falha de Equipamento/estatística & dados numéricos , Evolução Fatal , Migração de Corpo Estranho/etiologia , Migração de Corpo Estranho/cirurgia , Alemanha , Mortalidade Hospitalar , Humanos , Intestinos/cirurgia , Neoplasias Pulmonares/cirurgia , Complicações Pós-Operatórias/epidemiologia , Complicações Pós-Operatórias/mortalidade , Reoperação , Medição de Risco/estatística & dados numéricos , Grampeadores Cirúrgicos/normasRESUMO
A home made hydrogen/carbon analyser was used to determine the portion of exchangeable protons in aquatic humic substances. For this purpose, equal sample amounts were dissolved in H2O and D2O, respectively, dried and combusted in a stream of oxygen. The amount of water resulting from combustion was measured by an infrared detector which recorded the OH bending vibration of H2O. The bands stemming from HOD or D2O were not registered by the detection unit. Thus, combustion of organic samples containing exchangeable protons dissolved in D2O resulted in a significantly smaller signal compared to the signal observed for the same sample dissolved in H2O. The relative intensity loss of the H2O signal observed after combustion was used to derive the portion of exchangeable protons in a standard reference material, a humic substance isolated by the International Humic Substances Society (Suwannee River fulvic acid). According to this method about 20% of the sample protons could be identified as exchangeable protons. With regard to titration data the portion of protons bound to non acidic hydroxy functions could be estimated. The validity of this procedure was proved by combustion experiments using commercially available deuterated substances as well as organic model compounds dissolved in D2O and H2O, respectively.
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Varying degrees of organization of verbal material were presented to determine their use in sentence reproduction by acute and chronic schizophrenic subjects, a psychiatric (alcoholic) control group, and a healthy control group. The material consisted of six-word sentences presented over earphones, with background noise of differing intensity. The main result was that schizophrenics use verbal organization as effectively as healthy and psychiatric controls when reproducing the sentences. The noise distraction influenced performance of all groups similarly. Results suggest that performance of schizophrenics is facilitated by structured material (semantic and syntactic organization). The results do not suggest that either the linguistic repertoire or the application of linguistic rules is specifically affected in schizophrenia. The flatter performance slope of schizophrenics with increasing contexual constraints, found by some researchers, is explained by the unspecific effect of task difficulty.
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Memória , Rememoração Mental , Linguagem do Esquizofrênico , Fala , Doença Aguda , Adulto , Doença Crônica , Ensaios Clínicos como Assunto , Feminino , Humanos , Masculino , Ruído , Esquizofrenia , Percepção da FalaRESUMO
The performance assessment of technical systems for the supply of clean air is fraught with problems which are caused by the present assessment procedures and norms. Until now the distribution of germs in a clean room has been considered as stationary and has been tested as though it was independent of the measuring time. Accordingly the quality of clean air rooms has to date been determined by measurements of particle or germ concentrations (Federal Standard 209; European Standard 209-WG-1; VDI 2083/1). By contrast different methods demonstrate that the contaminations introduced into a clean air room as particles or as particle-bound bacteria are eliminated according to an exponential function in a time-dependent manner. Therefore the measurements of single concentrations without the consideration of the time-dependence of concentration changes must needs lead to extremely faulty results. Furthermore the influence of disturbing factors (test persons, properties of different air supply ceilings, measuring instruments). As a consequence of the poor reliability and lacking validity of presently valid assessment methods, there is a discrepancy between the seemingly high performance of the clean air supply systems under laboratory conditions (DIN 4799) on the one hand, and the frequently unsatisfactory functioning of the same systems under practical conditions. This discrepancy has caused a significant loss of confidence towards the whole clean air technique, especially among the users. Therefore critical test and evaluation methods should be immediately set up for comprehensive testing of technical clean air systems, methods which include the time-dependence of particle or germ elimination as well as test-dependent disturbing factors.