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1.
J Artif Organs ; 2024 May 20.
Artigo em Inglês | MEDLINE | ID: mdl-38769278

RESUMO

Preclinical testing using animal models is indispensable in cardiovascular research. However, the translation to clinical practice of these animal models is questionable since it is not always clear how representative they are. This systematic review intends to summarize the interspecies differences in the coagulation profile of animal models used in cardiovascular research. It aims to guide future research in choosing the optimal animal species. A literature search of PubMed, Embase, Web of Science (Core Collection) and Cochrane Library was performed using a search string that was well defined and not modified during the study. An overview of the search terms used in each database can be found in the appendix. Articles describing coagulation systems in large animals were included. We identified 30 eligible studies of which 15 were included. Compared to humans, sheep demonstrated a less active external pathway of coagulation. Sheep had a higher platelet count but the platelet activatability and response to biomaterials were lower. Both sheep and pigs displayed no big differences in the internal coagulation system compared to humans. Pigs showed results very similar to those of humans, with the exception of a higher platelet count and stronger platelet aggregation in pigs. Coagulation profiles of different species used for preclinical testing show strong variation. Adequate knowledge of these differences is key in the selection of the appropriate species for preclinical cardiovascular research. Future thrombogenicity research should compare sheep to pig in an identical experimental setup.

2.
J Surg Res ; 284: 6-16, 2023 04.
Artigo em Inglês | MEDLINE | ID: mdl-36527768

RESUMO

INTRODUCTION: To assess the safety and efficacy of an experimental large-diameter vascular graft externally sealed with an elastomeric polymer when used as an interposition graft in the descending aorta of sheep. METHODS: The experimental vascular grafts as well as control gelatin sealed interposition grafts were inserted into the descending aorta of juvenile sheep. The grafts were assessed by time to hemostasis and blood loss during surgery and hematology and biochemistry panels at distinct time points. Magnetic resonance imaging (MRI) was performed at 3 and at 6 mo after surgery, after which the animals were euthanized and necropsies were carried out including macroscopic and microscopic examination of the grafts, anastomoses, and distal organs. RESULTS: All animals survived the study period. There was no perceivable difference in the surgical handling of the grafts. The median intraoperative blood loss was 27.5 mL (range 10.0-125.0 mL) in the experimental group and 50.0 mL (range 10.0-75.0 mL) in the control group. The median time to hemostasis was 5.0 min (range 2.0-16.0 min) minutes in the experimental group versus 6.0 min (range 4.0-6.0 min) in the control group. MRI showed normal flow and graft patency in both groups. Healing and perianastomotic endothelialization was similar in both groups. CONCLUSIONS: The experimental graft has a similar safety and performance profile and largely comparable necropsy results, in comparison to a commonly used prosthetic vascular graft, with the experimental grafts eliciting a nonadherent external fibrous capsule as the major difference compared to the control grafts that were incorporated into the periadventitia. Survival, hemostatic sealing, and hematologic and radiologic results were comparable between the study groups.


Assuntos
Implante de Prótese Vascular , Prótese Vascular , Animais , Ovinos , Implante de Prótese Vascular/efeitos adversos , Elastômeros , Hemorragia , Grau de Desobstrução Vascular , Oclusão de Enxerto Vascular
3.
Thorac Cardiovasc Surg ; 71(7): 557-565, 2023 10.
Artigo em Inglês | MEDLINE | ID: mdl-36257545

RESUMO

OBJECTIVES: The aim of this study was to investigate the need for postoperative permanent pacemaker implantation (PPI) following sutureless and rapid-deployment aortic valve replacement (SuRD-AVR) in the context of a progress report from a large multicenter international registry (SURD-IR). METHODS: We retrospectively analyzed 4,166 patients who underwent SuRD-AVR between 2008 and 2019. The primary outcome was the need for PPI before discharge. The study population was analyzed separately according to the implanted prostheses (Su cohort and RD cohort). Each cohort was divided into two groups based on the operation date: an early group ("EG" = 2008-2016) and a late group ("LG" = 2017-2019). RESULTS: The rate of PPI decreased significantly in the Su cohort over time (EG = 10.8% vs LG = 6.3%, p < 0.001). In the Su cohort, a decrease in age, risk profile, and incidence of bicuspid aortic valve, increased use of anterior right thoracotomy, reduction of cardiopulmonary bypass time and of associated procedures, and more frequent use of smaller prostheses were observed over time. In the RD cohort, the rate of PPI was stable over time (EG = 8.8% vs LG = 9.3%, p = 0.8). In this cohort, a younger age, lower risk profile, and higher incidence of concomitant septal myectomy were observed over time. CONCLUSION: Our analysis showed a significant decrease in the PPI rate in patients who underwent Su-AVR over time. Patient selection as well as surgical improvements and a more accurate sizing could be correlated with this phenomenon. The RD cohort revealed no significant differences either in patient's characteristics or in PPI rate between the two time periods.


Assuntos
Estenose da Valva Aórtica , Implante de Prótese de Valva Cardíaca , Próteses Valvulares Cardíacas , Marca-Passo Artificial , Procedimentos Cirúrgicos sem Sutura , Humanos , Estenose da Valva Aórtica/cirurgia , Implante de Prótese de Valva Cardíaca/efeitos adversos , Implante de Prótese de Valva Cardíaca/métodos , Estudos Retrospectivos , Relatório de Pesquisa , Resultado do Tratamento , Desenho de Prótese , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/cirurgia , Procedimentos Cirúrgicos sem Sutura/efeitos adversos
4.
Eur J Vasc Endovasc Surg ; 63(1): 112-118, 2022 01.
Artigo em Inglês | MEDLINE | ID: mdl-34801385

RESUMO

OBJECTIVE: The aim of this study was to investigate the efficacy of vascular graft coatings used in the aortic position to prevent vascular graft infection (VGI). METHODS: A systematic review was conducted in accordance with the Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) guidelines using a pre-registered protocol (CRD42020206436). Eligible studies used a vascular graft coating in the aortic position and reported on VGI. A search was performed in MEDLINE (PubMed), Embase, Web of Science, and the Cochrane Library. Primary outcome parameters were VGI, patency, and mortality. Pooled estimates of VGI were calculated using odds ratio (OR) and 95% confidence intervals (CIs) wherever possible. Quality assessment was performed with the Newcastle-Ottawa Assessment Scale and the Revised Cochrane risk of bias tool for randomised trials. RESULTS: In total, 6 873 papers were identified. Only eight studies were included. Six of eight studies (75%) reported on known antimicrobial coating strategies such as antibiotics (n = 3) and silver (n = 3). In the other two studies, polymer coated grafts were used. Only three of eight studies compared coated with uncoated grafts (two antibiotic and one silver). Two randomised controlled trials reported on the effect of rifampicin soaked (1 mg/mL) grafts and showed no significant effect in the early (2 months; OR 0.69, 95% CI 0.29 - 1.62) or late (2 years; OR 0.73, 95% CI 0.23 - 2.32) post-operative periods. A retrospective cohort study focusing on the effect of silver coated grafts did not reveal any advantage (OR 0.19, 95% CI 0.02 - 1.64). Two polymer coated grafts were not considered to have a potential benefit in the prevention of VGIs. CONCLUSION: Clinical studies reporting on the antibacterial effect of vascular graft coatings in the aortic position to prevent VGI are scarce. For silver and antibiotic coatings, no significant protection for VGI was observed. New types of grafts or long acting coating strategies are mandatory to prevent this complication in the future.


Assuntos
Antibacterianos/administração & dosagem , Aorta/cirurgia , Prótese Vascular/efeitos adversos , Desenho de Prótese , Infecções Relacionadas à Prótese/prevenção & controle , Prata/administração & dosagem , Enxerto Vascular/efeitos adversos , Doenças da Aorta/cirurgia , Humanos , Polímeros/administração & dosagem
5.
Eur J Vasc Endovasc Surg ; 63(1): 119-137, 2022 01.
Artigo em Inglês | MEDLINE | ID: mdl-34674936

RESUMO

OBJECTIVE: Vascular graft infection (VGI) is a feared complication. Prevention is of the utmost importance and vascular graft coatings (VGCs) could offer a potential to do this, with in vitro research a first crucial step. The aim of this study was to summarise key features of in vitro models investigating coating strategies to prevent VGI in order to provide guidance for the setup of future translational research. DATA SOURCES: A comprehensive search was performed in MEDLINE, Embase, and Web of Science. METHODS: A systematic review was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-analyses guidelines. For each database, a specific search strategy was developed. Quality was assessed with the Toxicological data Reliability Assessment Tool (ToxRTool). In vitro models using a VGC and inoculation of the graft with a pathogen were included. The type of graft, coating, and pathogen were summarised. The outcome assessment in each study was evaluated. RESULTS: In total, 4 667 studies were identified, of which 45 papers met the inclusion criteria. The majority used polyester grafts (68.2%). Thirty-one studies (68.9%) included antibiotics, and nine studies (20%) used a commercial silver graft in their protocol. New antibacterial strategies (e.g., proteolytic enzymes) were investigated. A variety of testing methods was found and focused mainly on bacterial adherence, coating adherence and dilution, biofilm formation, and cytotoxicity. Ninety-three per cent of the studies (n = 41) were considered unreliable. CONCLUSION: Polyester is the preferred type of graft to coat on. The majority of coating studies are based on antibiotics; however, new coating strategies (e.g., antibiofilm coating) are coming. Many in vitro setups are available. In vitro studies have great potential, they can limit the use, but cannot replace in vivo studies completely. This paper can be used as a guidance document for future in vitro research.


Assuntos
Prótese Vascular , Desenho de Prótese , Infecções Relacionadas à Prótese/prevenção & controle , Antibacterianos/administração & dosagem , Humanos , Técnicas In Vitro , Poliésteres , Infecções Relacionadas à Prótese/microbiologia , Prata/administração & dosagem
6.
BMC Geriatr ; 22(1): 386, 2022 05 02.
Artigo em Inglês | MEDLINE | ID: mdl-35501840

RESUMO

BACKGROUND: Geriatric co-management is advocated to manage frail patients in the hospital, but there is no guidance on how to implement such programmes in practice. This paper reports our experiences with implementing the 'Geriatric CO-mAnagement for Cardiology patients in the Hospital' (G-COACH) programme. We investigated if G-COACH was feasible to perform after the initial adoption, investigated how well the implementation strategy was able to achieve the implementation targets, determined how patients experienced receiving G-COACH, and determined how healthcare professionals experienced the implementation of G-COACH. METHODS: A feasibility study of the G-COACH programme was performed using a one-group experimental study design. G-COACH was previously implemented on two cardiac care units. Patients and healthcare professionals participating in the G-COACH programme were recruited for this evaluation. The feasibility of the programme was investigated by observing the reach, fidelity and dose using registrations in the electronic patient record and by interviewing patients. The success of the implementation reaching its targets was evaluated using a survey that was completed by 48 healthcare professionals. The experiences of 111 patients were recorded during structured survey interviews. The experiences of healthcare professionals with the implementation process was recorded during 6 semi-structured interviews and 4 focus groups discussions (n = 27). RESULTS: The programme reached 91% in a sample of 151 patients with a mean age of 84 years. There was a high fidelity for the major components of the programme: documentation of geriatric risks (98%), co-management by specialist geriatrics nurse (95%), early rehabilitation (80%), and early discharge planning (74%), except for co-management by the geriatrician (32%). Both patients and healthcare professionals rated G-COACH as acceptable (95 and 94%) and feasible (96 and 74%). The healthcare professionals experienced staffing, competing roles and tasks of the geriatrics nurse and leadership support as important determinants for implementation. CONCLUSIONS: The implementation strategy resulted in the successful initiation of the G-COACH programme. G-COACH was perceived as acceptable and feasible. Fidelity was influenced by context factors. Further investigation of the sustainability of the programme is needed. TRIAL REGISTRATION: ISRCTN22096382 (21/05/2020).


Assuntos
Hospitais , Resolução de Problemas , Idoso , Idoso de 80 Anos ou mais , Estudos de Viabilidade , Geriatras , Pessoal de Saúde , Humanos
7.
J Vasc Surg ; 74(4): 1386-1393.e1, 2021 10.
Artigo em Inglês | MEDLINE | ID: mdl-34019984

RESUMO

OBJECTIVE: Vascular graft infection (VGI) is a serious complication with high mortality and morbidity rates. Several measures could be taken to decrease this risk, including the use of silver-containing vascular grafts. However, to date, no clinical advantages have been reported. This study reviews the outcome of preclinical studies focusing on the role of commercially available silver-coated grafts in the prevention of VGI. METHODS: A systematic review was performed with a focus on the preclinical role of commercially available silver-coated vascular grafts in the prevention and treatment of VGI. A comprehensive search was conducted in Medline, Embase, and Web of Science. RESULTS: Nine in vitro and five in vivo studies were included. Two commercial grafts were used (INTERGARD SILVER and Silver Graft). In vitro studies used both gram-positive and gram-negative strains. A positive antimicrobial effect was observed in seven of nine studies (77.8%). A delayed antifungal effect against Candida species was observed in vitro, but disappeared when adding serum proteins. In vivo studies witnessed a microbicidal effect in two out of five studies (40%), but only tested a single causative pathogen (ie, Staphylococcus aureus). CONCLUSIONS: Both in vitro and in vivo studies demonstrated conflicting and mixed results concerning the antimicrobial efficacy of commercially available silver-containing grafts in the prevention of VGI. In general, the study setup was heterogeneous in the different articles. Given the lack of convincing preclinical evidence and their poor performance in clinical studies, more data are needed at this time to guide the appropriate use of silver grafts.


Assuntos
Antibacterianos/administração & dosagem , Antifúngicos/administração & dosagem , Implante de Prótese Vascular/instrumentação , Prótese Vascular , Materiais Revestidos Biocompatíveis , Procedimentos Endovasculares/instrumentação , Infecções Relacionadas à Prótese/prevenção & controle , Compostos de Prata/administração & dosagem , Animais , Antibacterianos/toxicidade , Antifúngicos/toxicidade , Prótese Vascular/efeitos adversos , Implante de Prótese Vascular/efeitos adversos , Procedimentos Endovasculares/efeitos adversos , Análise de Falha de Equipamento , Humanos , Modelos Animais , Desenho de Prótese , Infecções Relacionadas à Prótese/diagnóstico , Infecções Relacionadas à Prótese/microbiologia , Compostos de Prata/toxicidade
8.
Eur J Vasc Endovasc Surg ; 62(1): 99-118, 2021 07.
Artigo em Inglês | MEDLINE | ID: mdl-33840577

RESUMO

OBJECTIVE: Vascular graft infection (VGI) remains an important complication with a high mortality and morbidity rate. Currently, studies focusing on the role of vascular graft coatings in the prevention of VGI are scarce. Therefore, the aims of this study were to survey and summarise key features of pre-clinical in vivo models that have been used to investigate coating strategies to prevent VGI and to set up an ideal model that can be used in future preclinical research. DATA SOURCES: A systematic review was conducted in accordance with the Preferred reporting items for Systematic Reviews and Meta-Analysis guidelines. A comprehensive search was performed in MEDLINE (PubMed), Embase, and Web of Science. REVIEW METHODS: For each database, a specific search strategy was developed. Quality was assessed with the Toxicological data Reliability Assessment Tool (ToxRTool). The type of animal model, graft, coating, and pathogen were summarised. The outcome assessment in each study was evaluated. RESULTS: In total, 4 667 studies were identified, of which 94 papers focusing on in vivo testing were included. Staphylococcus aureus was the organism most used (n = 65; 67.7%). Most of the graft types were polyester grafts. Rifampicin was the most frequently used antibiotic coating (n = 43, 48.3%). In the outcome assessment, most studies mentioned colony forming unit count (n = 88; 91.7%) and clinical outcome (n = 72; 75%). According to the ToxRTool, 21 (22.3%, n = 21/94) studies were considered to be not reliable. CONCLUSION: Currently published in vivo models are very miscellaneous. More attention should be paid to the methodology of these pre-clinical reports when transferring novel graft coatings into clinical practice. Variables used in pre-clinical reports (bacterial strain, duration of activity coating) do not correspond well to current clinical studies. Based on the results of this review, a proposal for a complete and comprehensive set up for pre-clinical invivo testing of anti-infectious properties of vascular graft coatings was defined.


Assuntos
Implante de Prótese Vascular/efeitos adversos , Prótese Vascular/efeitos adversos , Modelos Animais de Doenças , Infecções Relacionadas à Prótese/prevenção & controle , Infecções Estafilocócicas/prevenção & controle , Animais , Prótese Vascular/microbiologia , Implante de Prótese Vascular/instrumentação , Contagem de Colônia Microbiana , Estudos de Viabilidade , Humanos , Testes de Sensibilidade Microbiana , Infecções Relacionadas à Prótese/microbiologia , Reprodutibilidade dos Testes , Rifampina/administração & dosagem , Infecções Estafilocócicas/microbiologia , Staphylococcus aureus/efeitos dos fármacos , Staphylococcus aureus/isolamento & purificação
10.
J Surg Res ; 252: 37-46, 2020 08.
Artigo em Inglês | MEDLINE | ID: mdl-32222592

RESUMO

BACKGROUND: Abdominal aortic aneurysm (AAA) is a permanent and irreversible dilation of the lower region of the aorta. It is typically an asymptomatic condition that if left untreated can expand to the point of rupture. In simple mechanical terms, rupture of an artery occurs when the local wall stress exceeds the local wall strength. It is therefore understandable that numerous studies have attempted to estimate the AAA wall stress and investigate the relationship between the AAA wall stress and AAA symptoms. MATERIALS AND METHODS: We conducted computational biomechanics analysis for 19 patients with AAA (a proportion of these patients were classified as symptomatic) to investigate whether the AAA wall stress fields (both the patterns and magnitude) correlate with the clinical definition of symptomatic and asymptomatic AAAs. For computation of AAA wall stress, we used a very efficient method recently presented by the Intelligent Systems for Medicine Laboratory. The Intelligent Systems for Medicine Laboratory's method uses geometry from computed tomography images and mean arterial pressure as the applied load. The method is embedded in the software platform BioPARR-Biomechanics based Prediction of Aneurysm Rupture Risk, freely available from http://bioparr.mech.uwa.edu.au/. The uniqueness of our stress computation approach is three-fold: i) the results are insensitive to unknown patient-specific mechanical properties of arterial wall tissue; ii) the residual stress is accounted for, according to Y.C. Fung's Uniform Stress Hypothesis; and iii) the analysis is automated and quick, making our approach compatible with clinical workflows. RESULTS: Symptomatic patients could not be identified from the plots (pattern) of AAA wall stress and stress magnitude. Although the largest stress was predicted for a patient who suffered from AAA symptoms, the three patients with the smallest stress were also symptomatic. CONCLUSIONS: The results demonstrate, contrary to the common view, that neither the wall stress magnitude nor the stress distribution appears to be associated with the presence of clinical symptoms.


Assuntos
Aorta Abdominal/fisiopatologia , Aneurisma da Aorta Abdominal/diagnóstico , Ruptura Aórtica/prevenção & controle , Modelos Cardiovasculares , Estresse Mecânico , Idoso , Idoso de 80 Anos ou mais , Aorta Abdominal/diagnóstico por imagem , Aneurisma da Aorta Abdominal/complicações , Aneurisma da Aorta Abdominal/fisiopatologia , Ruptura Aórtica/etiologia , Ruptura Aórtica/fisiopatologia , Doenças Assintomáticas , Simulação por Computador , Feminino , Análise de Elementos Finitos , Humanos , Masculino , Pessoa de Meia-Idade , Modelagem Computacional Específica para o Paciente , Estudos Retrospectivos , Medição de Risco/métodos , Software , Tomografia Computadorizada por Raios X
11.
Br J Anaesth ; 2020 Jan 28.
Artigo em Inglês | MEDLINE | ID: mdl-32005514

RESUMO

BACKGROUND: Older patients undergoing cardiac surgery have a 40-60% risk of developing postoperative delirium (POD), which is associated with increased morbidity and mortality. In animals, xenon has been found to be neuroprotective. Little is known about its neuroprotective effects in humans. We evaluated whether xenon anaesthesia prevents POD in patients undergoing cardiac surgery. METHODS: We conducted a randomised, observer-blind, controlled trial in which 190 patients 65 yr or older undergoing on-pump cardiac surgery were randomly allocated to xenon or sevoflurane anaesthesia. During cardiopulmonary bypass, propofol infusion was used for anaesthetic maintenance. Subjects were screened for POD daily during the first 5 postoperative days using the 3-Minute Diagnostic Interview for Confusion Assessment Method (CAM) or with a CAM version for patients in ICU (CAM-ICU). Other methods to detect delirium, such as chart review, were also used. Secondary outcomes included the duration and severity of POD, and postoperative cognitive function. RESULTS: The overall incidence of POD was 41% (78/190). There was no statistically significant difference in the POD incidence between the xenon and sevoflurane groups (42.7% [41/96] vs 39.4% [37/94], P=0.583). The odds ratio for POD when comparing xenon with sevoflurane was 1.18 (95% confidence interval, 0.65-2.16). CONCLUSIONS: In older patients undergoing cardiac surgery, xenon anaesthesia did not result in a significant reduction in POD. Based on these results alone, use of xenon cannot be recommended for this purpose. CLINICAL TRIAL REGISTRATION: EudraCT: 2014-005370-11 (May 13, 2015; https://www.clinicaltrialsregister.eu/ctr-search/search?query=2014-005370-11).

12.
BMC Geriatr ; 20(1): 112, 2020 03 20.
Artigo em Inglês | MEDLINE | ID: mdl-32197581

RESUMO

BACKGROUND: Up to one in three of older patients who are hospitalised develop functional decline, which is associated with sustained disability, institutionalisation and death. This study developed and validated a clinical prediction model that identifies patients who are at risk for functional decline during hospitalisation. The predictive value of the model was compared against three models that were developed for patients admitted to a general medical ward. METHODS: A prospective cohort study was performed on two cardiac care units between September 2016 and June 2017. Patients aged 75 years or older were recruited on admission if they were admitted for non-surgical treatment of an acute cardiovascular disease. Hospitalisation-associated functional decline was defined as any decrease on the Katz Index of Activities of Daily Living between hospital admission and discharge. Predictors were selected based on a review of the literature and a prediction score chart was developed based on a multivariate logistic regression model. RESULTS: A total of 189 patients were recruited and 33% developed functional decline during hospitalisation. A score chart was developed with five predictors that were measured on hospital admission: mobility impairment = 9 points, cognitive impairment = 7 points, loss of appetite = 6 points, depressive symptoms = 5 points, use of physical restraints or having an indwelling urinary catheter = 5 points. The score chart of the developed model demonstrated good calibration and discriminated adequately (C-index = 0.75, 95% CI (0.68-0.83) and better between patients with and without functional decline (chi2 = 12.8, p = 0.005) than the three previously developed models (range of C-index = 0.65-0.68). CONCLUSION: Functional decline is a prevalent complication and can be adequately predicted on hospital admission. A score chart can be used in clinical practice to identify patients who could benefit from preventive interventions. Independent external validation is needed.


Assuntos
Atividades Cotidianas/psicologia , Doenças Cardiovasculares/terapia , Cuidados Críticos/psicologia , Avaliação Geriátrica/métodos , Pacientes Internados/psicologia , Idoso , Idoso de 80 Anos ou mais , Envelhecimento/psicologia , Doenças Cardiovasculares/diagnóstico , Doenças Cardiovasculares/epidemiologia , Estudos de Coortes , Feminino , Hospitalização , Humanos , Masculino , Valor Preditivo dos Testes , Estudos Prospectivos , Fatores de Risco
13.
Thorac Cardiovasc Surg ; 68(2): 114-123, 2020 03.
Artigo em Inglês | MEDLINE | ID: mdl-30497085

RESUMO

INTRODUCTION: Sutureless biological valves for surgical aortic valve replacement (SAVR), characterized by the absence of anchoring sutures at the aortic annulus, are gaining popularity because of ease and reproducibility of implant, shorter operating times, and enhancement of minimally invasive approaches. The stentless configuration of the sutureless valve was designed to achieve optimal hemodynamic performance. MATERIALS AND METHODS: PERSIST-AVR (PERceval Sutureless Implant versus STandard Aortic Valve Replacement) is a prospective, randomized, adaptive, open-label, international, postmarket trial (NCT02673697). The primary objective of the trial is to assess the safety and efficacy of the Perceval (LivaNova, London, UK) sutureless bioprosthesis among patients undergoing SAVR in the presence of severe aortic stenosis to demonstrate the noninferiority of Perceval as compared with standard sutured stented bioprosthetic aortic valve as an isolated procedure or combined with coronary artery bypass grafting. Sample size will be determined adaptively through interim analyses performed by an Independent Statistical Unit till a maximum of 1,234 patients, enrolled at ∼60 sites in countries where the device is commercially available. Patients will be followed up for 5 years after implant. The primary end point is the number of patients free from major adverse cardiac and cerebrovascular-related events at 1 year. Additional secondary outcomes will be assessed up to 5 years. DISCUSSION: PERSIST-AVR is the first prospective, randomized study comparing in-hospital and postdischarge outcomes in a robust population of patients undergoing SAVR with either the Perceval sutureless bioprosthesis or a conventional sutured stented bioprosthesis up to 5 years.


Assuntos
Estenose da Valva Aórtica/cirurgia , Valva Aórtica/cirurgia , Bioprótese , Implante de Prótese de Valva Cardíaca/instrumentação , Próteses Valvulares Cardíacas , Stents , Procedimentos Cirúrgicos sem Sutura/instrumentação , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/fisiopatologia , Estenose da Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/fisiopatologia , Implante de Prótese de Valva Cardíaca/efeitos adversos , Hemodinâmica , Humanos , Vigilância de Produtos Comercializados , Estudos Prospectivos , Desenho de Prótese , Recuperação de Função Fisiológica , Índice de Gravidade de Doença , Procedimentos Cirúrgicos sem Sutura/efeitos adversos , Fatores de Tempo , Resultado do Tratamento
14.
J Card Surg ; 35(8): 1761-1764, 2020 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-32667077

RESUMO

On 11 March 2020, the World Health Organization declared the SARS-CoV-2 outbreak a pandemic. At the time of writing, 24 May 2020 more than 5 million individuals have been tested positive and the death toll was over 330 000 deaths worldwide. The initial data pointed out the tight bond between cardiovascular diseases and worse health outcomes in COVID19-patients. Epidemiologically speaking, there is an overlap between the age-groups more affected by COVID-related death and the age-groups in which Cardiac Surgery has its usual base of patients. The Cardiac Surgery Departments have to think to a new normal: since the virus will remain endemic in the society, dedicated pathways or even dedicated Teams are pivotal to treat safely the patients, in respect of the safety of the health care workers. Moreover, we need a keen eye on deciding which pathologies have to be treated with priority: Coronary artery Disease showed a higher mortality rate in patients affected by COVID19, but it is, however, reasonable to think that all the cardiac pathologies affecting the lung circulation-such as symptomatic severe mitral diseases or aortic stenosis-might deserve a priority access to treatment, to increase the survival rate in case of an acquired-Coronavirus infection later on.


Assuntos
Procedimentos Cirúrgicos Cardíacos , Infecções por Coronavirus/prevenção & controle , Reestruturação Hospitalar , Controle de Infecções/organização & administração , Pandemias/prevenção & controle , Pneumonia Viral/prevenção & controle , Triagem/organização & administração , Betacoronavirus , COVID-19 , Doenças Cardiovasculares , Comorbidade , Infecções por Coronavirus/epidemiologia , Unidades Hospitalares , Humanos , Pneumonia Viral/epidemiologia , SARS-CoV-2
16.
J Cardiovasc Pharmacol ; 71(4): 215-222, 2018 04.
Artigo em Inglês | MEDLINE | ID: mdl-29300219

RESUMO

INTRODUCTION: Available evidence suggests that the renin-angiotensin-aldosterone (RAA) system is a good target for medical intervention on aortic root dilatation in Marfan syndrome (MFS). The effect of Compound 21 (C21), a nonpeptide angiotensin II type 2 receptor agonist, on aneurysm progression was tested. METHODS: Mice with a mutation in fibrillin-1 (Fbn1) and wild-type mice were treated with vehicle, losartan, C21, enalapril, or a combination. Blood pressure, aortic root diameter, and histological slides were evaluated. RESULTS: All groups had a comparable blood pressure. Echographic evaluation of the aortic root diameter revealed a protective effect of angiotensin II type 1 receptor antagonist (losartan) and no effect of C21 treatment. None of the treatments had a beneficial effect on the histological changes in MFS. DISCUSSION: This study confirms that angiotensin II type 1 receptor antagonism (losartan) decreases aortic aneurysm growth in a mouse model of MFS. A nonpeptide angiotensin II type 2 receptor agonist (C21), at the doses studied, was ineffective. Future studies are warranted to further elucidate the exact role of the RAA system in aneurysm formation in MFS and identify alternative targets for intervention.


Assuntos
Aorta/efeitos dos fármacos , Aneurisma Aórtico/prevenção & controle , Síndrome de Marfan/tratamento farmacológico , Receptor Tipo 2 de Angiotensina/agonistas , Sulfonamidas/farmacologia , Tiofenos/farmacologia , Bloqueadores do Receptor Tipo 1 de Angiotensina II/farmacologia , Animais , Aorta/diagnóstico por imagem , Aorta/metabolismo , Aorta/patologia , Aneurisma Aórtico/genética , Aneurisma Aórtico/metabolismo , Aneurisma Aórtico/patologia , Dilatação Patológica , Modelos Animais de Doenças , Progressão da Doença , Ecocardiografia , Fibrilina-1/genética , Losartan/farmacologia , Masculino , Síndrome de Marfan/complicações , Síndrome de Marfan/genética , Síndrome de Marfan/metabolismo , Camundongos Endogâmicos C57BL , Camundongos Mutantes , Mutação , Receptor Tipo 2 de Angiotensina/metabolismo
17.
Ann Vasc Surg ; 52: 225-236, 2018 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-29772327

RESUMO

BACKGROUND: Abdominal aortic aneurysms (AAAs) are a potentially deathly disease, needing surgical or endovascular treatment. To evaluate potentially new diagnostic tools and treatments, a large animal model, which resembles not only the morphological characteristics but also the pathophysiological background, would be useful. METHODS: Rodent animal aneurysm models were extrapolated to sheep. Four groups were created: intraluminal infusion with an elastase-collagenase solution (n = 4), infusion with elastase-collagenase solution combined with proximal stenosis (n = 7), aortic xenograft (n = 3), and elastase-collagenase-treated xenograft (n = 4). At fixed time intervals (6, 12, and 24 weeks), computer tomography and autopsy with histological evaluation were performed. RESULTS: The described models had a high perioperative mortality (45%), due to acute aortic thrombosis or fatale hemorrhage. A maximum aortic diameter increase of 30% was obtained in the protease-stenosis group. In the protease-treated groups, some histological features of human AAAs, such as inflammation, thinning of the media, and loss of elastin could be reproduced. In the xenotransplant groups, a pronounced inflammatory reaction was visible at the start. In all models, inflammation decreased and fibrosis occurred at long follow-up, 24 weeks postoperatively. CONCLUSIONS: None of the extrapolated small animal aneurysm models could produce an AAA in sheep with similar morphological features as the human disease. Some histological findings of human surgical specimens could be reproduced in the elastase-collagenase-treated groups. Long-term histological evaluation indicated stabilization and healing of the aortic wall months after the initial stimulus.


Assuntos
Aorta Abdominal/cirurgia , Aneurisma da Aorta Abdominal/induzido quimicamente , Colagenases , Elastase Pancreática , Animais , Aorta Abdominal/diagnóstico por imagem , Aorta Abdominal/patologia , Aneurisma da Aorta Abdominal/diagnóstico por imagem , Aneurisma da Aorta Abdominal/patologia , Aortografia/métodos , Angiografia por Tomografia Computadorizada , Modelos Animais de Doenças , Progressão da Doença , Estudos de Viabilidade , Feminino , Xenoenxertos , Ratos , Carneiro Doméstico , Fatores de Tempo
18.
Age Ageing ; 46(6): 903-910, 2017 11 01.
Artigo em Inglês | MEDLINE | ID: mdl-28444116

RESUMO

Background: geriatric consultation teams have failed to impact clinical outcomes prompting geriatric co-management programmes to emerge as a promising strategy to manage frail patients on non-geriatric wards. Objective: to conduct a systematic review of the effectiveness of in-hospital geriatric co-management. Data sources: MEDLINE, EMBASE, CINAHL and CENTRAL were searched from inception to 6 May 2016. Reference lists, trial registers and PubMed Central Citations were additionally searched. Study selection: randomised controlled trials and quasi-experimental studies of in-hospital patients included in a geriatric co-management study. Two investigators performed the selection process independently. Data extraction: standardised data extraction and assessment of risk of bias were performed independently by two investigators. Results: twelve studies and 3,590 patients were included from six randomised and six quasi-experimental studies. Geriatric co-management improved functional status and reduced the number of patients with complications in three of the four studies, but studies had a high risk of bias and outcomes were measured heterogeneously and could not be pooled. Co-management reduced the length of stay (pooled mean difference, -1.88 days [95% CI, -2.44 to -1.33]; 11 studies) and may reduce in-hospital mortality (pooled odds ratio, 0.72 [95% CI, 0.50-1.03]; 7 studies). Meta-analysis identified no effect on the number of patients discharged home (5 studies), post-discharge mortality (3 studies) and readmission rate (4 studies). Conclusions: there was low-quality evidence of a reduced length of stay and a reduced number of patients with complications, and very low-quality evidence of better functional status as a result of geriatric co-management.


Assuntos
Geriatras , Geriatria/métodos , Admissão do Paciente , Equipe de Assistência ao Paciente , Idoso , Idoso de 80 Anos ou mais , Comportamento Cooperativo , Feminino , Avaliação Geriátrica , Mortalidade Hospitalar , Humanos , Comunicação Interdisciplinar , Tempo de Internação , Masculino , Alta do Paciente , Readmissão do Paciente , Prognóstico , Encaminhamento e Consulta , Fatores de Risco , Fatores de Tempo
19.
Anesth Analg ; 125(4): 1118-1128, 2017 10.
Artigo em Inglês | MEDLINE | ID: mdl-28598913

RESUMO

BACKGROUND: Xenon was shown to cause less hemodynamic instability and reduce vasopressor needs during off-pump coronary artery bypass (OPCAB) surgery when compared with conventionally used anesthetics. As xenon exerts its organ protective properties even in subanesthetic concentrations, we hypothesized that in patients undergoing OPCAB surgery, 30% xenon added to general anesthesia with propofol results in superior hemodynamic stability when compared to anesthesia with propofol alone. METHODS: Fifty patients undergoing elective OPCAB surgery were randomized to receive general anesthesia with 30% xenon adjuvant to a target-controlled infusion of propofol or with propofol alone. The primary end point was the total intraoperative dose of norepinephrine required to maintain an intraoperative mean arterial pressure >70 mm Hg. Secondary outcomes included the perioperative cardiorespiratory profile and the incidence of adverse and serious adverse events. RESULTS: Adding xenon to propofol anesthesia resulted in a significant reduction of norepinephrine required to attain the predefined hemodynamic goals (cumulative intraoperative dose: median [interquartile range]: 370 [116-570] vs 840 [335-1710] µg, P = .001). In the xenon-propofol group, significantly less propofol was required to obtain a similar depth of anesthesia as judged by clinical signs and the bispectral index (propofol effect site concentration [mean ± SD]: 1.8 ± 0.5 vs 2.8 ± 0.3 mg, P≤ .0001). Moreover, the xenon-propofol group required significantly less norepinephrine during the first 24 hours on the intensive care unit (median [interquartile range]: 1.5 [0.1-7] vs 5 [2-8] mg, P = .048). Other outcomes and safety parameters were similar in both groups. CONCLUSIONS: Thirty percent xenon added to propofol anesthesia improves hemodynamic stability by decreasing norepinephrine requirements in patients undergoing OPCAB surgery.


Assuntos
Anestésicos Inalatórios/administração & dosagem , Anestésicos Intravenosos/administração & dosagem , Ponte de Artéria Coronária sem Circulação Extracorpórea/métodos , Propofol/administração & dosagem , Xenônio/administração & dosagem , Idoso , Anestesia Geral/métodos , Quimioterapia Adjuvante/métodos , Feminino , Hemodinâmica/efeitos dos fármacos , Hemodinâmica/fisiologia , Humanos , Masculino , Pessoa de Meia-Idade , Norepinefrina/administração & dosagem
20.
Surg Today ; 47(10): 1268-1273, 2017 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-28386747

RESUMO

PURPOSE: To evaluate and compare the clinical outcomes and hospital costs of using sutureless aortic valves vs conventional stented aortic valves. METHODS: Between 2007 and 2011, 52 elderly patients undergoing aortic valve replacement for aortic stenosis in our center had a sutureless valve inserted. From among 180 patients who had a stented valve inserted during the same period, 52 patients were matched to the sutureless group, based on age, gender, and operation type. We compared clinical outcomes and hospital costs between the two groups. RESULTS: The sutureless group had a higher Euroscore (logistic Euroscore I) risk (12.8 vs 9.7; p = 0.02), with significantly shorter aortic cross-clamp (ACC) time (p < 0.01), cardiopulmonary bypass (CPB) time (p < 0.01), intensive care unit stay (p < 0.01), intubation time (p < 0.01), and overall hospital stay (p = 0.05). The sutureless group also revealed a significant hospital cost saving of approximately 8200€ (p = 0.01). CONCLUSIONS: The clinical and hemodynamic outcomes of using the sutureless bioprosthesis were excellent. The reduced ACC and CPB times had a favorable effect on the duration of intubation and intensive care stay, resulting not only in faster recovery and discharge home, but also in a significant hospital cost reduction.


Assuntos
Estenose da Valva Aórtica/economia , Estenose da Valva Aórtica/cirurgia , Valva Aórtica/cirurgia , Redução de Custos/economia , Implante de Prótese de Valva Cardíaca/economia , Implante de Prótese de Valva Cardíaca/métodos , Custos Hospitalares , Stents/economia , Procedimentos Cirúrgicos sem Sutura/economia , Fatores Etários , Idoso , Idoso de 80 Anos ou mais , Estenose da Valva Aórtica/fisiopatologia , Bioprótese , Ponte Cardiopulmonar , Estudos de Casos e Controles , Feminino , Hemodinâmica , Humanos , Tempo de Internação/economia , Masculino , Estudos Retrospectivos , Risco , Fatores Sexuais , Fatores de Tempo , Resultado do Tratamento
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