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1.
Neurogastroenterol Motil ; : e14904, 2024 Aug 27.
Artigo em Inglês | MEDLINE | ID: mdl-39189312

RESUMO

BACKGROUND: Gastric fluid plays a key role in food digestion and drug dissolution, therefore, the amount of gastric fluid present in a fasted state may influence subsequent digestion and drug delivery. We aimed to describe intra- and interindividual variation in fasted gastric content volume (FGCV) and to determine the association with age, sex, and body size characteristics. METHODS: Data from 24 MRI studies measuring FGCV in healthy, mostly young individuals after an overnight fast were pooled. The analysis included 366 participants who had up to 6 repeated measurements, with a total of 870 measurements. Linear mixed model analysis was performed to calculate intra- and interindividual variability and to assess the effects of age, sex, weight, height, weight*height as a proxy for body size, and body mass index (BMI). RESULTS: FGCV ranged from 0 to 156 mL, with a mean (± SD) value of 33 ± 25 mL. The overall coefficient of variation within the study population was 75.6%, interindividual SD was 15 mL, and the intraindividual SD was 19 mL. Age, weight, height, weight*height, and BMI had no effect on FGCV. Women had lower volumes compared to men (MD: -6 mL), when corrected for the aforementioned factors. CONCLUSION: FGCV is highly variable, with higher intraindividual compared to interindividual variability, indicating that FGCV is subject to day-to-day and within-day variation and is not a stable personal characteristic. This highlights the importance of considering FGCV when studying digestion and drug dissolution. Exact implications remain to be studied.

4.
Ann Thorac Surg ; 2024 Jul 02.
Artigo em Inglês | MEDLINE | ID: mdl-38964702

RESUMO

BACKGROUND: The impact of sex-differences on the release of cardiac biomarkers after coronary artery bypass grafting (CABG) remains unknown. The aim of our study was to (1) investigate the impact of sex-differences in cardiac biomarker release after CABG and (2) determine sex-specific thresholds for high-sensitivity cardiac troponin (hs-cTn) and creatine kinase-myocardial band (CK-MB) associated with 30-day major adverse cardiovascular events (MACE) and mortality. METHODS: A consecutive cohort of 3687 patients, comprising 643 women (17.4%) and 3044 men (82.6%), undergoing CABG from 2008 to 2021 in 2 tertiary university centers with serial postoperative cTn and CK-MB measurement was analyzed. The composite primary outcome was MACE at 30 days. Secondary end points were 30-day mortality and 5-year mortality and MACE. Sex-specific thresholds for cTn and CK-MB were determined. RESULTS: Lower levels of cTn were found in women after CABG (69.18 vs 77.57 times the upper reference limit [URL]; P < .001). The optimal threshold value for cTn was calculated at 94.36 times the URL for female patients and 206.07 times the URL for male patients to predict 30-day MACE. Female patients missed by a general threshold had increased risk for MACE or death within 30 days (cTn: MACE: odds ratio [OR], 3.78; 95% CI, 1.03-13.08; P = .035; death: OR, 4.98; 95% CI, 1.20-20.61; P = .027; CK-MB: MACE: OR, 10.04; 95% CI, 2.07-48.75; P < .001; death: OR 13.59; 95% CI, 2.66-69.47; P = .002). CONCLUSIONS: We provide evidence for sex-specific differences in the outcome and biomarker release after CABG. Sex-specific cutoffs are necessary for the diagnosis of perioperative myocardial injury to improve outcomes of women after CABG.

5.
Eur J Pharm Sci ; 201: 106853, 2024 Oct 01.
Artigo em Inglês | MEDLINE | ID: mdl-39033883

RESUMO

Although older people are the main users of oral medications, few studies are reported on the influence of advanced age on gastric emptying rate of non-caloric liquids. This study aimed at evaluating the gastric emptying of 240 ml water in healthy older and young adults in fasted and fed state conditions using the established method of salivary caffeine kinetics. The gastric emptying of water was evaluated in 12 healthy older volunteers (mean age: 73 ± 6 years) and 12 healthy younger volunteers (mean age: 25 ± 2 years) with the ingestion of a rapid disintegrating tablet containing 20 mg of 13C3-caffeine. The gastric emptying of water was assessed indirectly by calculating the AUC ratios of salivary caffeine concentrations in specific time segments. Comparison of the AUC ratios showed no statistically significant difference between young and older volunteers in both fasted and fed state conditions (p > 0.05). Advanced age itself seems to have no relevant effect on gastric emptying of water in either fasted or fed state conditions and the phenomenon of Magenstrasse appears to follow a similar pattern in healthy older adults as in healthy younger adults.


Assuntos
Cafeína , Jejum , Esvaziamento Gástrico , Água , Humanos , Esvaziamento Gástrico/fisiologia , Jejum/fisiologia , Adulto , Idoso , Masculino , Feminino , Água/metabolismo , Cafeína/administração & dosagem , Cafeína/farmacocinética , Adulto Jovem , Saliva/metabolismo , Saliva/química , Envelhecimento/fisiologia , Idoso de 80 Anos ou mais
6.
Eur Heart J ; 45(29): 2634-2643, 2024 Aug 03.
Artigo em Inglês | MEDLINE | ID: mdl-38898573

RESUMO

BACKGROUND AND AIMS: In chronic ischaemic heart failure, revascularisation strategies control symptoms but are less effective in improving left ventricular ejection fraction (LVEF). The aim of this trial is to investigate the safety of cardiac shockwave therapy (SWT) as a novel treatment option and its efficacy in increasing cardiac function by inducing angiogenesis and regeneration in hibernating myocardium. METHODS: In this single-blind, parallel-group, sham-controlled trial (cardiac shockwave therapy for ischemic heart failure, CAST-HF; NCT03859466) patients with LVEF ≤40% requiring surgical revascularisation were enrolled. Patients were randomly assigned to undergo direct cardiac SWT or sham treatment in addition to coronary bypass surgery. The primary efficacy endpoint was the improvement in LVEF measured by cardiac magnetic resonance imaging from baseline to 360 days. RESULTS: Overall, 63 patients were randomized, out of which 30 patients of the SWT group and 28 patients of the Sham group attained 1-year follow-up of the primary endpoint. Greater improvement in LVEF was observed in the SWT group (Δ from baseline to 360 days: SWT 11.3%, SD 8.8; Sham 6.3%, SD 7.4, P = .0146). Secondary endpoints included the 6-minute walking test, where patients randomized in the SWT group showed a greater Δ from baseline to 360 days (127.5 m, SD 110.6) than patients in the Sham group (43.6 m, SD 172.1) (P = .028) and Minnesota Living with Heart Failure Questionnaire score on day 360, which was 11.0 points (SD 19.1) for the SWT group and 17.3 points (SD 15.1) for the Sham group (P = .15). Two patients in the treatment group died for non-device-related reasons. CONCLUSIONS: In conclusion, the CAST-HF trial indicates that direct cardiac SWT, in addition to coronary bypass surgery improves LVEF and physical capacity in patients with ischaemic heart failure.


Assuntos
Ponte de Artéria Coronária , Insuficiência Cardíaca , Isquemia Miocárdica , Volume Sistólico , Humanos , Masculino , Feminino , Insuficiência Cardíaca/terapia , Insuficiência Cardíaca/fisiopatologia , Método Simples-Cego , Pessoa de Meia-Idade , Isquemia Miocárdica/terapia , Isquemia Miocárdica/fisiopatologia , Isquemia Miocárdica/complicações , Isquemia Miocárdica/cirurgia , Volume Sistólico/fisiologia , Idoso , Resultado do Tratamento , Terapia Combinada , Ondas de Choque de Alta Energia/uso terapêutico
7.
Z Evid Fortbild Qual Gesundhwes ; 187: 42-52, 2024 Jun.
Artigo em Alemão | MEDLINE | ID: mdl-38744602

RESUMO

BACKGROUND: The Good Practice Guidelines for health information, Good Health Information Austria and Guideline Evidence-based Health Information are established resources for developing evidence-based health information in the German-speaking regions. The aim of this project was to capture challenges in applying these standards in practice, identify gaps and development needs and gain insights for their further development. METHODS: In December 2020, members of the working group for patient information and involvement of the Network for Evidence-based Medicine were invited to share their experiences and needs in applying German standards for evidence-based health information through an online survey focussing on open questions (part 1: needs assessment). The feedback was analysed using qualitative content analysis and presented in a workshop at the EbM Congress 2021 with the goal of specifying the feedback from the needs assessment and discussing ideas for the further development of the standards (part 2: specification). In the final step, a second survey was conducted in February 2023 to prioritize the identified topics by the working group members (part 3: prioritization). The results were analysed descriptively. RESULTS: Among the 41 participants, only 23% considered the standards to be sufficient, and only 55% found their application in the development of information to be easy or rather easy. The needs assessment and workshop (n=46) helped to identify various areas of action. With regard to the application of the standards, the following challenges were identified: lack of user orientation, content gaps, methods and risk communication. Gaps in the standards were identified regarding formats, content, and the connection to healthcare provision. For the advancement of the standards ideas for additional content, stakeholder involvement, and improvement of the usability of the standards were identified. In the prioritization survey, the topic areas, "presenting benefits and harms" and "content beyond treatments (in particular, diagnostics and prognosis)" were considered to be the most important (n=36). DISCUSSION: Among members of the working group for patient information and involvement of the German Network for Evidence-based Medicine, a high demand has been identified for the further development of standards for creating evidence-based health information. In addition to content development, the integration of existing documents and tools should also be considered, including products issued by other institutions. The success of advancing the standards also depends on improving their applicability - for example through an attractive online platform. The results are limited by the sample which only included members of the EbM Network's patient information and participation working group and a limited response rate. CONCLUSIONS: The needs assessment showed that the currently established standards and recommendations for the development of evidence-based health information in the German-speaking regions represent important cornerstones but need to be expanded to answer more practice-oriented questions. The challenges and proposed solutions stated by the participants can help further develop the standards. The prioritization can be used to set priorities for the development of the standards, guide the order of possible work packages and allocate resources.


Assuntos
Medicina Baseada em Evidências , Avaliação das Necessidades , Humanos , Medicina Baseada em Evidências/normas , Avaliação das Necessidades/normas , Informação de Saúde ao Consumidor/normas , Alemanha , Áustria , Guias de Prática Clínica como Assunto/normas , Necessidades e Demandas de Serviços de Saúde/normas , Prioridades em Saúde/normas
8.
Curr Oncol Rep ; 26(7): 735-743, 2024 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-38748364

RESUMO

PURPOSE OF REVIEW: To review the current management of the axilla in breast cancer. RECENT FINDINGS: Axillary dissection is no longer indicated in patients with clinically node-negative axilla with 1-2 positive sentinel lymph nodes following upfront surgery or in patients with clinically node-negative axilla following neoadjuvant chemotherapy. Breast cancer has evolved away from routine axillary clearance to the less invasive sentinel lymph node biopsy to now complete omission of axillary sampling in select patients. We will review the most salient evidence that has shaped these practice changes over the last three decades. Current practice controversies are especially relevant for elderly populations and those receiving neoadjuvant therapy. Ongoing clinical trials will provide data to further guide breast cancer surgical management.


Assuntos
Axila , Neoplasias da Mama , Excisão de Linfonodo , Biópsia de Linfonodo Sentinela , Humanos , Neoplasias da Mama/patologia , Neoplasias da Mama/cirurgia , Neoplasias da Mama/tratamento farmacológico , Feminino , Terapia Neoadjuvante , Metástase Linfática , Linfonodos/patologia , Linfonodos/cirurgia
9.
Eur J Cardiothorac Surg ; 65(6)2024 Jun 03.
Artigo em Inglês | MEDLINE | ID: mdl-38781502

RESUMO

OBJECTIVES: Barlow's disease is a specific sub-form of mitral valve (MV) disease, characterized by diffuse excessive tissue and multi segment prolapse. The anterolateral mini-thoracotomy represents the standard access for MV regurgitation in many centres. It still remains unclear which surgical technique provides the best results. Therefore, the aim of this study was to compare operative safety and mid-term outcomes after (i) isolated annuloplasty, (ii) use of additional artificial chordae or (iii) leaflet resection in patients suffering from Barlow's disease undergoing minimally invasive MV repair. METHODS: A consecutive series of patients suffering from Barlow's disease undergoing minimally invasive MV surgery between 2001 and 2020 were analysed (n = 246). Patients were grouped and analysed according to the used surgical technique. The primary outcome was a modified Mitral Valve Academic Research Consortium combined end-point of mortality, reoperation due to repair failure or reoccurrence of severe mitral regurgitation within 5 years. The secondary outcome included operative success and safety up to 30 days. RESULTS: No significant difference was found between the 3 surgical techniques with regard to operative safety (P = 0.774). The primary outcome did not differ between groups (P = 0.244). Operative success was achieved in 93.5% and was lowest in the isolated annuloplasty group (77.1%). Conversion to MV replacement was increased in patients undergoing isolated annuloplasty (P < 0.001). CONCLUSIONS: Isolated annuloplasty, use of additional artificial chordae and leaflet resection represent feasible techniques in Barlow patients undergoing minimally invasive MV surgery with comparable 5-year results. In view of the increased conversion rate in the annuloplasty group, the pathology should not be oversimplified.


Assuntos
Procedimentos Cirúrgicos Minimamente Invasivos , Anuloplastia da Valva Mitral , Prolapso da Valva Mitral , Valva Mitral , Humanos , Feminino , Masculino , Prolapso da Valva Mitral/cirurgia , Procedimentos Cirúrgicos Minimamente Invasivos/métodos , Pessoa de Meia-Idade , Valva Mitral/cirurgia , Anuloplastia da Valva Mitral/métodos , Anuloplastia da Valva Mitral/efeitos adversos , Resultado do Tratamento , Estudos Retrospectivos , Insuficiência da Valva Mitral/cirurgia , Idoso , Adulto , Implante de Prótese de Valva Cardíaca/métodos , Implante de Prótese de Valva Cardíaca/mortalidade , Implante de Prótese de Valva Cardíaca/efeitos adversos
10.
Eur J Pharm Sci ; 200: 106814, 2024 Sep 01.
Artigo em Inglês | MEDLINE | ID: mdl-38815699

RESUMO

Dosing conditions (type and amount of accompanying fluid, the type of food, the time of administration, and dosage form modifications such as crushing tablets) are critical and affect the performance of oral dosage forms in the gastrointestinal tract and thus bioavailability. Because older adults are the primary users of medications and are more susceptible to adverse effects, it is important to understand how they take their medications in order to reduce risks and increase benefits of the pharmacotherapy. The aim of the study was to investigate the real-life drug intake behaviour in geriatric patients and older adults and discuss their influence on drug absorption after oral administration. The data from two settings home vs. hospital and genders women vs. men were presented. A questionnaire study was performed among people aged at least 65 years from two settings (hospital vs. home), recruited mostly from community pharmacies and a regional hospital in Mecklenburg - Western Pomerania. The obtained data demonstrates that older adults and geriatric patients take their medications in the same way regardless of the setting and gender. There were no significant differences. Interviewed participants were mostly adherent to the doctor's recommendations and mostly took their medications in the same way every day. Medications are most commonly taken with a small (100 mL) or large (200 mL) glass of noncarbonated water, after food (during or after breakfast 64 % of intakes in the morning and during or after dinner 81 % of intakes in the evening). Meal usually consisted of bread, either with jam or honey (breakfast), or ham and cheese (dinner). All reported dosage form modifications were made to tablets. In almost all cases it was splitting the tablet, which was performed due to doctor's indication.


Assuntos
Comprimidos , Humanos , Masculino , Idoso , Feminino , Alemanha , Idoso de 80 Anos ou mais , Administração Oral , Inquéritos e Questionários , Adesão à Medicação
11.
BMJ Glob Health ; 9(5)2024 May 22.
Artigo em Inglês | MEDLINE | ID: mdl-38777393

RESUMO

INTRODUCTION: Non-communicable diseases (NCDs) have surpassed infectious diseases as the leading global cause of death, with the Southeast Asian region experiencing a significant rise in NCD prevalence over the past decades. Despite the escalating burden, screening for NCDs remains at very low levels, resulting in undetected cases, premature mortality and high public healthcare costs. We investigate whether community-based NCD prevention and management programmes are an effective solution. METHODS: In Indonesia, we compare participants in the community-based NCD screening and management programme Pos Pembinaan Terpadu-Penyakit Tidak Menular with matched non-participants with respect to their uptake of screening activities, health-related behaviour and knowledge and metabolic risk factors. We use statistical matching to redress a possible selection bias (n=1669). In Viet Nam, we compare members of Intergenerational Self-Help Clubs, which were offered similar NCD health services, with members of other community groups, where such services were not offered. We can rely on two waves of data and use a double-difference approach to redress a possible selection bias and to measure the impacts of participation (n=1710). We discuss strengths and weaknesses of the two approaches in Indonesia and Viet Nam. RESULTS: In Indonesia, participants have significantly higher uptake of screening for hypertension and diabetes (+13% from a control mean of 88% (95% CI 9% to 17%); +93% from a control mean of 48% (95% CI 79% to 108%)). In both countries, participants show a higher knowledge about risk factors, symptoms and complications of NCDs (Indonesia: +0.29 SD (0.13-0.45), Viet Nam: +0.17 SD (0.03-0.30)). Yet, the improved knowledge is only partly reflected in improved health behaviour (Viet Nam: fruit consumption +0.33 SD (0.15-0.51), vegetable consumption +0.27 SD (0.04-0.50)), body mass index (BMI) (Viet Nam: BMI -0.07 SD (-0.13 to -0.00)) or metabolic risk factors (Indonesia: systolic blood pressure: -0.13 SD (-0.26 to -0.00)). CONCLUSION: Community-based NCD programmes are well suited to increase screening and to transmit health knowledge. Due to their extensive outreach within the community, they can serve as a valuable complement to the screening services provided at the primary healthcare level. Yet, limited coverage, insufficient resources and a high staff turnover remain a problem. TRIAL REGISTRATION NUMBER: NCT05239572.


Assuntos
Hipertensão , Adulto , Idoso , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Serviços de Saúde Comunitária , Diabetes Mellitus/prevenção & controle , Diabetes Mellitus/epidemiologia , Conhecimentos, Atitudes e Prática em Saúde , Hipertensão/prevenção & controle , Indonésia , Programas de Rastreamento , Avaliação de Programas e Projetos de Saúde , Fatores de Risco , Vietnã
12.
Eur J Pharm Biopharm ; 199: 114313, 2024 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-38718842

RESUMO

The aim of the present study was to investigate the gastroretentive capacity of different formulation principles. This was indirectly determined by the absorption behavior of caffeine from the dosage forms. A slow and continuous appearance of caffeine in the saliva of healthy volunteers was used as a parameter for a prolonged gastric retention time. For this purpose, a four-way study was conducted with twelve healthy volunteers using the following test procedures: (1) Effervescent granules with 240 mL of still water administered in fed state, (2) effervescent granules with 20 mL of still water in fed state, (3) extended release (ER) tablet with 240 mL of still water in fed state, and (4) effervescent granules with 240 mL of still water in fasted state. The initial rise of the caffeine concentrations was more pronounced after the intake of the effervescent granules in the fed state compared to that of the ER tablets. However, tmax tended to be shorter in the fed study arms following administration of the ER tablet compared to the granules. Overall, the application of active pharmaceutical ingredients formulated as effervescent granules seems to be a promising approach to increase their gastric residence time after intake in fed state.


Assuntos
Cafeína , Preparações de Ação Retardada , Comprimidos , Humanos , Cafeína/administração & dosagem , Cafeína/farmacocinética , Preparações de Ação Retardada/farmacocinética , Preparações de Ação Retardada/administração & dosagem , Masculino , Adulto , Adulto Jovem , Feminino , Jejum , Administração Oral , Saliva/metabolismo , Saliva/química , Voluntários Saudáveis , Mucosa Gástrica/metabolismo , Estudos Cross-Over , Estômago/efeitos dos fármacos
13.
J Endovasc Ther ; : 15266028241256817, 2024 May 30.
Artigo em Inglês | MEDLINE | ID: mdl-38817015

RESUMO

BACKGROUND: Thrombotic material in the non-aneurysmatic and non-atherosclerotic aorta is a rare entity without any recommended standard treatment so far. We present a successful treatment strategy for patients who do not fit into any of the common approaches. CASE REPORT: A free-floating thrombus in the descending aorta was found as source of embolism in an 82-year-old female patient with lower limb ischemia. After initial heparinization of the patient without relevant reduction of the thrombotic mass, the thrombus was removed using an interdisciplinary approach. Under echocardiographic guidance to locate the thrombus, the AngioVac device, usually licensed to remove floating thrombi from the venous system, was used off-label to remove the thrombus by a transfemoral approach. To avoid rebuilding of a new thrombus, the attachment point with an exulcerated plaque in the descending aorta was covered by a stent graft via the same femoral access. The patient did not experience any further embolic events, and the postoperative course was uncomplicated. CONCLUSION: Patients with uncommon aortic diseases, such as the reported free-floating thrombus, should be treated by an individualized, interdisciplinary approach. Besides the recommended treatment options, there are other uncommon approaches that might offer an alternative in complex cases. CLINICAL IMPACT: Evidence is rare for the treatment of a free-floating thrombus in the descending aorta and the treatment strategy remains discussed controversially. We present a rather uncommon approach of successful off-label treatment for patients who do not fit into any of the common approaches (operative, endovascular, or conservative treatment based on patient's comorbidities). The AngioVac System has already been successfully used off-label in the arterial system but not in the above presented way of treating a free-floating thrombus in a patient with high embolization risk and treatment-limiting comorbidities.

14.
Mol Pharm ; 21(6): 2828-2837, 2024 Jun 03.
Artigo em Inglês | MEDLINE | ID: mdl-38723178

RESUMO

Nefecon, a targeted-release capsule formulation of budesonide approved for the reduction of proteinuria in adults with primary immunoglobulin A nephropathy, targets overproduction of galactose-deficient immunoglobulin A type 1 in the Peyer's patches at the gut mucosal level. To investigate whether the commercial formulation of Nefecon capsules reliably releases budesonide to the distal ileum, a human study was conducted with test capsules reproducing the delayed-release function of Nefecon capsules. Caffeine was included in the test capsules as a marker for capsule opening in the gut since it appears rapidly in saliva after release from orally administered dosage forms. Magnetic resonance imaging with black iron oxide was used to determine the capsule's position in the gut at the time caffeine was first measured in saliva and additionally to directly visualize dispersion of the capsule contents in the gut. In vitro dissolution results confirmed that the test capsules had the same delayed-release characteristics as Nefecon capsules. In 10 of 12 human volunteers, the capsule was demonstrated to open in the distal ileum; in the other two subjects, it opened just past the ileocecal junction. These results compared favorably with the high degree of variability seen in other published imaging studies of delayed-release formulations targeting the gut. The test capsules were shown to reliably deliver their contents to the distal ileum, the region with the highest concentration of Peyer's patches.


Assuntos
Budesonida , Cápsulas , Sistemas de Liberação de Medicamentos , Íleo , Humanos , Íleo/metabolismo , Íleo/efeitos dos fármacos , Adulto , Sistemas de Liberação de Medicamentos/métodos , Masculino , Budesonida/administração & dosagem , Budesonida/farmacocinética , Budesonida/química , Feminino , Cápsulas/química , Preparações de Ação Retardada/administração & dosagem , Preparações de Ação Retardada/farmacocinética , Imageamento por Ressonância Magnética/métodos , Administração Oral , Pessoa de Meia-Idade , Cafeína/química , Cafeína/administração & dosagem , Nódulos Linfáticos Agregados/metabolismo , Nódulos Linfáticos Agregados/efeitos dos fármacos , Adulto Jovem
15.
Eur J Pharm Biopharm ; 198: 114277, 2024 May.
Artigo em Inglês | MEDLINE | ID: mdl-38582180

RESUMO

BACKGROUND: The transit and distribution pattern of fluids in the small intestine is a key parameter for the dissolution and absorption of drugs. Although some information is known about the small intestinal water content after administration of fluid volumes and meals, the intestinal transit of orally ingested fluids and solutions has been barely investigated. The aim of this three-arm, cross-over, 9-subject human study was to investigate the transit of orally ingested water in the small intestine under fasting and postprandial conditions using MRI. To identify the ingested water, manganese gluconate, which can be identified with T1-weighted MRI sequences, was added as a marker. Using Horos (DICOM software), quantification of the distribution of Mn2+ ions in the gastrointestinal tract in fasted versus fed state (standard meal by FDA guidance and a light meal) was possible. The distribution and approximate wetted intestinal length was very similar in the fasting and postprandial states, suggesting rapid transport of water ingested after a meal through the chyme-filled small intestine in continuation of the "Magenstrasse" (stomach road). In some subjects, manganese gluconate reached deeper parts of the small intestine even more quickly in the postprandial state than in the fasting arm of the study. A deeper understanding of the behaviour of solutes in the gastrointestinal tract is fundamental to a mechanistic explanation for the kinetic interaction between food and drug intake (food effects).


Assuntos
Esvaziamento Gástrico , Gluconatos , Intestino Delgado , Humanos , Imageamento por Ressonância Magnética , Água , Estudos Cross-Over
16.
Artigo em Inglês | MEDLINE | ID: mdl-38514397

RESUMO

Latest research has indicated a potential adverse effect on graft patency rates and clinical outcomes with skeletonizing the left internal thoracic artery. We aim to provide a prospective, randomized, multicentre trial to compare skeletonized versus pedicled harvesting technique of left internal thoracic artery concerning graft patency rates and patient survival. A total of 1350 patients will be randomized to either skeletonized or pedicled harvesting technique and undergo surgical revascularization. Follow-up will be performed at 30 days, 1 year, 2 years and 5 years after surgery. The primary outcome will be death or left internal thoracic artery graft occlusion in coronary computed tomography angiography or invasive angiography within 2 years (+/- 3 months) after surgery. The secondary outcome will be major adverse cardiac events (composite outcome of all-cause death, myocardial infarction and repeated revascularization) within 1 year, 2 years and 5 years after surgery. The primary end point will be compared in the modified intention-to-treat population between the two treatment groups using Kaplan-Meier graphs, together with log-rank testing. Hereby, we present the study protocol of the first adequately powered prospective, randomized, multicentre trial which compares skeletonized and pedicled harvesting technique of left internal thoracic artery regarding graft patency rates and patient survival.

17.
Front Cardiovasc Med ; 11: 1345439, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-38370160

RESUMO

Objective: In patients with complex coronary artery disease (CAD) undergoing cardiac surgery, myocardial protection might be impaired due to microvascular obstruction, resulting in myocardial injury and subsequent biomarker release. Therefore, this study investigated the correlation between the complexity of CAD, reflected by the SYNTAX Score, and the release of cardiac biomarkers after CABG. Methods: In a consecutive series of 919 patients undergoing isolated CABG SYNTAX scores I and II were calculated to assess the complexity of CAD. Levels of high sensitivity cardiac troponin T (hs-cTnT) and creatine kinase-myocardial band (CK-MB) were routinely measured once before and serially after surgery. Patients were divided into tertiles according to their SYNTAX Scores I and II. Spearman correlations and regression models were performed to measure the degree of association between the release of hs-cTnT and CK-MB and the SYNTAX Scores. Results: Patients with a higher SYNTAX Score I had more comorbidities reflected in a higher EuroSCORE II. Preoperatively, higher levels of cardiac biomarkers were found in patients with higher SYNTAX Score II. No correlation was observed between hs-cTnT, CK-MB and SYNTAX Score I or II. Regression models did not show any association between cardiac biomarkers and the complexity of CAD. Conclusion: The complexity of CAD is not associated with the release of cardiac biomarkers after CABG. Factors influencing postoperative biomarker release need to be elucidated in future trials to include postoperative biomarker release into risk stratification models predicting outcome after cardiac surgery.

18.
Eur J Cardiothorac Surg ; 65(1)2024 Jan 02.
Artigo em Inglês | MEDLINE | ID: mdl-38175777

RESUMO

OBJECTIVES: Cardiopulmonary resuscitation (CPR) aggravates the pre-existing dismal prognosis of patients suffering from acute type A aortic dissection (ATAAD). We aimed to identify factors affecting survival and outcome in ATAAD patients requiring CPR at presentation at 2 European aortic centres. METHODS: Data on 112 surgical candidates and undergoing preoperative CPR were retrospectively evaluated. Patients were divided into 2 groups according to 30-day mortality. A multivariable model identified predictors for 30-day mortality. RESULTS: Preoperative death occurred in 23 patients (20.5%). In the remaining 89 surgical patients (79.5%) circulatory arrest time (41 ± 20 min in 30-day non-survivors vs 30 ± 13 min in 30-day survivor, P = 0.003) as well as cardiopulmonary bypass time (320 ± 132 min in 30-day non-survivors vs 252 ± 140 min in 30-day survivor, P = 0.020) time was significantly longer in patients with worse outcome. Thirty-day mortality of the total cohort was 61.6% (n = 69) with cardiac failure in 48% and aortic rupture or haemorrhagic shock (28%) as predominant reasons of death. Age [odds ratio (OR) 1.04, 95% confidence interval (CI) 1.01-1.09, P = 0.034], preoperative coronary (OR 3.42, 95% CI 1.34-9.26, p = 0.012) and spinal malperfusion (OR 12.49, 95% CI 1.83-225.02, P = 0.028) emerged as independent predictors for 30-day mortality while CPR due to tamponade was associated with improved early survival (OR 0.29, 95% CI 0.091-0.81, P = 0.023). CONCLUSIONS: Assessment of underlying cause for CPR is mandatory. Pericardial tamponade, rapidly resolved with pericardial drainage, is a predictor for improved survival, while age and presence of coronary and spinal malperfusion are associated with dismal outcome in this high-risk patient group.


Assuntos
Dissecção Aórtica , Reanimação Cardiopulmonar , Humanos , Resultado do Tratamento , Estudos Retrospectivos , Dissecção Aórtica/complicações , Dissecção Aórtica/cirurgia , Prognóstico , Fatores de Risco , Doença Aguda
20.
Artigo em Inglês | MEDLINE | ID: mdl-38113401

RESUMO

OBJECTIVES: Myocardial hypertrophy results in increased levels of cardiac biomarkers in healthy individuals and in patients suffering from acute myocardial infarction. The influence of cardiac mass on postoperative cardiac biomarkers release remains unclear. This study investigated the correlation between myocardial mass and the release of high-sensitivity cardiac Troponin T (hs-cTnT) and creatine kinase-myocardial band (CK-MB) after isolated aortic valve replacement (AVR) or bypass surgery. METHODS: Myocardial mass of a consecutive retrospective series of patients was measured automatically using preoperative computer tomography scans (636 patients, AVR = 251; bypass surgery = 385). Levels of cardiac biomarkers were measured before and serially after surgery. Spearman and Pearson correlation and a multivariate regression model was performed to measure the degree of association between myocardial mass and the release of hs-cTnT and CK-MB. RESULTS: Patients were divided into 3 tertiles according to their myocardial mass index. Higher biomarker levels were measured preoperatively in the upper tertile of patients undergoing AVR (P = 0.004) or bypass surgery (P < 0.001). Patients with different heart sizes showed no differences in postoperative biomarker release neither after AVR nor bypass surgery. No statistical significant correlation was observed between myocardial mass index and postoperative release of hs-cTnT or CK-MB in any subgroup (ρ maximum 0.106). CONCLUSIONS: Postoperative biomarker release is not correlated with myocardial mass. Patient factors leading to increased postoperative biomarker levels need to be elucidated in future studies.

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