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5.
J Transl Med ; 20(1): 270, 2022 Jun 15.
Artigo em Inglês | MEDLINE | ID: mdl-35706006

RESUMO

BACKGROUND: Heart failure (HF) is a global leading cause of mortality despite implementation of guideline directed therapy which warrants a need for novel treatment strategies. Proof-of-concept clinical trials of anakinra, a recombinant human Interleukin-1 (IL-1) receptor antagonist, have shown promising results in patients with HF. METHOD: We designed a single center, randomized, placebo controlled, double-blind phase II randomized clinical trial. One hundred and two adult patients hospitalized within 2 weeks of discharge due to acute decompensated HF with reduced ejection fraction (HFrEF) and systemic inflammation (high sensitivity of C-reactive protein > 2 mg/L) will be randomized in 2:1 ratio to receive anakinra or placebo for 24 weeks. The primary objective is to determine the effect of anakinra on peak oxygen consumption (VO2) measured at cardiopulmonary exercise testing (CPX) after 24 weeks of treatment, with placebo-corrected changes in peak VO2 at CPX after 24 weeks (or longest available follow up). Secondary exploratory endpoints will assess the effects of anakinra on additional CPX parameters, structural and functional echocardiographic data, noninvasive hemodynamic, quality of life questionnaires, biomarkers, and HF outcomes. DISCUSSION: The current trial will assess the effects of IL-1 blockade with anakinra for 24 weeks on cardiorespiratory fitness in patients with recent hospitalization due to acute decompensated HFrEF. TRIAL REGISTRATION: The trial was registered prospectively with ClinicalTrials.gov on Jan 8, 2019, identifier NCT03797001.


Assuntos
Insuficiência Cardíaca , Adulto , Método Duplo-Cego , Humanos , Proteína Antagonista do Receptor de Interleucina 1/farmacologia , Proteína Antagonista do Receptor de Interleucina 1/uso terapêutico , Interleucina-1 , Qualidade de Vida , Volume Sistólico/fisiologia , Resultado do Tratamento
6.
Panminerva Med ; 2022 May 30.
Artigo em Inglês | MEDLINE | ID: mdl-35638241

RESUMO

BACKGROUND: Physical activity (PA) is an established modifiable factor for the prevention of cardiovascular disease. Our objective was to assess the association of PA with mortality rates in a national sample of patients with diabetes. METHODS: We analyzed a nationally representative sample from The National Health and Nutrition Examination Survey (NHANES, periods 2003-2004 and 2005-2006) that used Physical Activity Monitors. Individuals were matched for BMI, number of steps/ per day and age. Three groups were created: subjects with less than 5000/steps per day (low), 5000-7500/steps per day (moderate) and more than 7500/steps per day (high levels of physical activity). All-cause mortality was ascertained through December 2015. RESULTS: A sample of 3,072 individuals (1018 with diabetes) was analyzed. Patients with diabetes had 30% increased risk of mortality of all causes (RR: 1,298, 95% CI [1,162-1,451], p< 0,001), Higher levels of physical activity (> 7500 steps/day) provided similar relative risk for subjects with diabetes compared to their controls [RR:1,256 (95% CI 0,910-1,732)]. In a Poisson model adjusted for sex, history of previous cardiovascular event or cancer, ethnicity, Hb1ac, SBP, and total cholesterol to HDL ratio, patients with diabetes and moderate or high PA had an associated 44% to 80% lower risk of all-cause mortality compared to those with low PA. CONCLUSIONS: The subgroup of patients with diabetes and high PA had no excess of mortality compared to the general population. PA can reduce the gap for all-cause mortality, used as an index of cardiovascular fitness and a clinical tool for the assessment of mortality risk.

7.
Panminerva Med ; 2022 May 30.
Artigo em Inglês | MEDLINE | ID: mdl-35638242

RESUMO

BACKGROUND: Transcatheter aortic valve implantation (TAVI) is an established management strategy for severe aortic valve stenosis. Percutaneous axillary approach for TAVI holds the promise of improving safety without jeopardizing effectiveness in comparison to surgical access. We aimed at appraising the comparative effectiveness of percutaneous vs surgical axillary approaches for TAVI. METHODS: We performed an international retrospective observational study using de-identified details on baseline, procedural, and 1-month follow-up features. Valve Academic Research Consortium (VARC)-3 criteria were applied throughout. Outcomes of interest were clinical events up to 1 month of follow-up, compared with unadjusted and propensity score-adjusted analyses. RESULTS: A total of 432 patients were included, 189 (43.8%) receiving surgical access, and 243 (56.2%) undergoing percutaneous access. Primary hemostasis failure was more common in the percutaneous group (13.2% vs 4.2%, p<0.001), leading to more common use of covered stent implantation (13.2% vs 3.7%, p<0.001). Irrespectively, percutaneous access was associated with shorter hospital stay (-2.6 days [95% confidence interval: -5.0; -0.1], p=0.038), a lower risk of major adverse events (a composite of death, myocardial infarction, stroke, type 3 bleeding, and major access-site related complication; odds ratio=0.44 [0.21; 0.95], p=0.036), major access-site non-vascular complications (odds ratio=0.21 [0.06; 0.77], p=0.018), and brachial plexus impairment (odds ratio=0.16 [0.03; 0.76], p=0.021), and shorter hospital stay (-2.6 days [-5.0; -0.1], p=0.038). CONCLUSIONS: Percutaneous axillary access provides similar or better results than surgical access in patients undergoing TAVI with absolute or relative contraindications to femoral access.

8.
J Invasive Cardiol ; 34(6): E419-E427, 2022 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-35551105

RESUMO

BACKGROUND: The differential outcomes between pure/predominant aortic stenosis (AS) and mixed aortic valve disease (MAVD) in patients undergoing transcatheter aortic valve implantation (TAVI) are still debated. OBJECTIVE: To evaluate the comparative clinical outcomes of patients with MAVD and AS undergoing TAVI using data from the RISPEVA registry. METHODS: A total of 3263 patients were included. Of the 3263 patients, 656 with concomitant moderate/severe aortic regurgitation constituted the MAVD group and 2607 constituted the AS cohort. Primary endpoints were 30-day mortality and 1-year survival. Postprocedural paravalvular regurgitation (PPVR), cerebrovascular events, bleeding, and vascular complications were assessed at 30 days. RESULTS: In the overall population, 30-day mortality in the MAVD group was higher than in AS patients (4.3% vs 2.6%;P=.02); however, no differences were detected after propensity-score matching (4.1% vs 3.5%; P=.62). One-year survival was comparable between MAVD and AS patients in both unmatched and matched cohorts. Left ventricular ejection fraction, pulmonary artery systolic pressure, and PPVR, but not baseline MAVD, were predictors of 30-day mortality. The incidence of PPVR was higher in the MAVD group vs the AS group; this difference was not confirmed in patients implanted with a balloon-expandable device. CONCLUSION: MAVD per se did not negatively affect patients' prognoses, but appears to identify a more complex cohort of patients with a worse clinical and functional status, probably referred to TAVI in a later stage of the disease. Patients with MAVD had a greater propensity to develop PPVR, which is a known predictor of worse outcome; this tendency seems to be mitigated by the implantation of balloon-expandable valves.


Assuntos
Estenose da Valva Aórtica , Próteses Valvulares Cardíacas , Substituição da Valva Aórtica Transcateter , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/cirurgia , Estenose da Valva Aórtica/diagnóstico , Estenose da Valva Aórtica/cirurgia , Humanos , Pontuação de Propensão , Sistema de Registros , Volume Sistólico , Resultado do Tratamento , Função Ventricular Esquerda
10.
Sci Rep ; 12(1): 7612, 2022 05 09.
Artigo em Inglês | MEDLINE | ID: mdl-35534616

RESUMO

Transcatheter aortic valve implantation (TAVI) requires thorough preprocedural planning with non-invasive imaging, including computed tomography (CT). The plethora of details obtained with thoraco-abdominal CT represents a challenge for accurate and synthetic decision-making. We devised and tested a comprehensive score suitable to summarize CT exams when planning TAVI. An original comprehensive scoring system (TAVI-CT score) was devised, including details on cardiac, aortic, iliac and femoral artery features. The score was applied to a prospectively collected series of patients undergoing TAVI at our institution, driving decision making on access and prosthesis choice. Different TAVI-CT score groups were compared in terms of procedural success, acute complications, and early clinical outcomes. We included a total of 200 undergoing TAVI between February 2020 and May 2021, with 74 (37.0%) having a low (0-2) TAVI-CT score, 50 (25.0%) having a moderate (3) TAVI-CT score, and 76 (38.0%) having a high (≥ 4) TAVI-CT score. Male gender was the only non-CT variable significantly associated with the TAVI-CT score (p = 0.001). As expected, access choice differed significantly across TAVI-CT scores (p = 0.009), as was device choice, with Portico more favored and Allegra less favored in the highest TAVI-CT score group (p = 0.036). Acute outcomes were similar in the 3 groups, including device and procedural success rates (respectively p = 0.717 and p = 1). One-month follow-up showed similar rates of death, myocardial infarction, stroke, and bleeding, as well as of a composite safety endpoint (all p > 0.05). However, vascular complications were significantly more common in the highest TAVI-CT score group (p = 0.041). The TAVI-CT score is a simple scoring system that could be routinely applied to CT imaging for TAVI planning, if the present hypothesis-generating findings are confirmed in larger prospective studies.


Assuntos
Estenose da Valva Aórtica , Substituição da Valva Aórtica Transcateter , Estenose da Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/etiologia , Estenose da Valva Aórtica/cirurgia , Humanos , Masculino , Estudos Prospectivos , Desenho de Prótese , Tomografia Computadorizada por Raios X , Substituição da Valva Aórtica Transcateter/métodos , Resultado do Tratamento
12.
Artigo em Inglês | MEDLINE | ID: mdl-35557027

RESUMO

Transcatheter aortic valve implantation (TAVI) has proved beneficial in patients with severe aortic stenosis, especially when second-generation devices are used. We aimed at reporting our experience with Navitor, a third-generation device characterized by intrannular, large cell, and cuffed design, as well as high deliverability and minimization of paravalvular leak. Between June and December 2021, a total of 39 patients underwent TAVI with Navitor, representing 20% of all TAVI cases. Mean age was 80.0 ± 6.7 years, and 14 (36.8%) women were included. Severe aortic stenosis was the most common indication to TAVI (37 [97.4%] cases), whereas 2 (5.3%) individuals were at low surgical risk. Device and procedural success was obtained in all patients, with a total hospital stay of 6.6 ± 4.5 days. One (2.9%) patient required permanent pacemaker implantation, but no other hospital events occurred. At 1-month follow-up, a cardiac death was adjudicated in an 87-year-old man who had been at high surgical risk. Echocardiographic follow-up showed no case of moderate or severe aortic regurgitation, with mild regurgitation in 18 (47%), and none or trace regurgitation in 20 (53%). The Navitor device, thanks to its unique features, is a very promising technology suitable to further expand indications and risk-benefit profile of TAVI.

13.
J Invasive Cardiol ; 34(4): E319-E325, 2022 04.
Artigo em Inglês | MEDLINE | ID: mdl-35366226

RESUMO

BACKGROUND: The next iteration of drug-eluting stents (DESs) for percutaneous coronary intervention (PCI) has focused on bioresorbable polymers and thin struts. The Alex Plus DES is a new-generation sirolimus-eluting device with 70-µm cobalt chromium struts, a 5-µm bioresorbable polymer and a very small profile. Despite such favorable features, limited data are available to estimate the risk-benefit profile of Alex Plus. We aimed at comparing the effectiveness of Alex Plus in real-world practice. METHODS: Retrospective clinical data on patients treated with Alex Plus at our institutions were collected and clinical outcome data over follow-up were obtained, comparing them with those of subjects receiving Xience, a leading DES with permanent polymer. RESULTS: A total of 100 patients (126 lesions) treated with Alex Plus and 753 subjects (1020 lesions) receiving Xience were included. Baseline and procedural features were largely similar in the 2 groups, with the notable exception of age, sex, and left circumflex coronary artery as the target vessel. Clinical follow-up showed that patients with Alex Plus had a significantly higher risk of major adverse clinical event (MACE), mainly driven by an excess in repeat PCI (hazard ratio, 4.81; 95% confidence interval, 2.83-8.20; P<.001). Even after propensity-score matching, Alex Plus was associated with an increased risk of MACE (P<.001). CONCLUSIONS: Our clinical experience to date with Alex Plus has been disappointing, despite the favorable promises. Further improvements are likely needed in the Alex Plus DES, most likely in drug delivery, before this device is considered for routine clinical use in complex patients or lesions.


Assuntos
Doença da Artéria Coronariana , Stents Farmacológicos , Intervenção Coronária Percutânea , Doença da Artéria Coronariana/diagnóstico , Doença da Artéria Coronariana/etiologia , Doença da Artéria Coronariana/cirurgia , Stents Farmacológicos/efeitos adversos , Humanos , Intervenção Coronária Percutânea/efeitos adversos , Pontuação de Propensão , Estudos Retrospectivos
14.
J Invasive Cardiol ; 34(4): E334-E342, 2022 04.
Artigo em Inglês | MEDLINE | ID: mdl-35366228

RESUMO

OBJECTIVES: We aimed to assess which bifurcation technique performs best in unprotected left-main (LM) percutaneous coronary intervention (PCI). BACKGROUND: Provisional stenting was considered the preferred technique for LM bifurcation PCI due to the supposed lower risks of thrombosis and restenosis. However, recent studies showed potential advantages of double kissing (DK)-crush technique over the other strategies. METHODS: We performed a frequentist network meta-analysis comparing different stenting techniques in the setting of LM bifurcation. PubMed, Embase, the Cochrane Central Register of Controlled Trials, and Clinicaltrials.gov were searched. Both randomized clinical trials and non-randomized clinical trials were considered eligible for inclusion. Incidence rate ratios (IRRs) were computed using a random-effects model for death, cardiac death, myocardial infarction, target-vessel revascularization, target-lesion revascularization, and stent thrombosis, including 95% confidence intervals (CIs). RESULTS: A total of 10 studies (2364 patients) were included. Compared with provisional stenting, DK-crush was associated with fewer cardiac deaths (IRR, 0.34; 95% CI, 0.17-0.70; P<.01), myocardial infarctions (IRR, 0.19; 95% CI, 0.08-0.44; P<.001), stent thromboses (IRR, 0.31; 95% CI, 0.14-0.69; P<.01), target-vessel revascularizations (IRR, 0.25; 95% CI, 0.14-0.46; P<.001), and target-lesion revascularizations (IRR, 0.25; 95% CI, 0.14-0.46; P<.001). DK-crush was also associated with a lower risk of myocardial infarction (IRR, 0.19; 95% CI, 0.05-0.76; P=.02) when compared with standard crush and lower risk of target-lesion revascularization when compared with culotte (IRR, 0.32; 95% CI, 0.12-0.83; P=.02) and crush (IRR, 0.07; 95% CI, 0.02-0.28; P<.001). CONCLUSIONS: DK-crush is the best technique for unprotected LM bifurcation PCI.


Assuntos
Doença da Artéria Coronariana , Intervenção Coronária Percutânea , Doença da Artéria Coronariana/diagnóstico , Doença da Artéria Coronariana/cirurgia , Humanos , Metanálise em Rede , Intervenção Coronária Percutânea/efeitos adversos , Intervenção Coronária Percutânea/métodos , Stents , Resultado do Tratamento
16.
Artigo em Inglês | MEDLINE | ID: mdl-35384898

RESUMO

ABSTRACT: The microbiota of the gastrointestinal tract (GIT) is an extremely diverse community of microorganisms, and their collective genomes (microbiome) provide a vast arsenal of biological activities, in particular enzymatic ones, which are far from being fully elucidated. The study of the microbiota (and the microbiome) is receiving great interest from the biomedical community as it carries the potential to improve risk-prediction models, refine primary and secondary prevention efforts, and also design more appropriate and personalized therapies, including pharmacological ones. A growing body of evidence, though sometimes impaired by the limited number of subjects involved in the studies, suggests that GIT dysbiosis, i.e. the altered microbial composition, has an important role in causing and/or worsening cardiovascular disease (CVD). Bacterial translocation as well as the alteration of levels of microbe-derived metabolites can thus be important to monitor and modulate, because they may lead to initiation and progression of CVD, as well as to its establishment as chronic state. We hereby aim to provide readers with details on available resources and experimental approaches that are used in this fascinating field of biomedical research, and on some novelties on the impact of GIT microbiota on CVD.

17.
Curr Probl Cardiol ; : 101215, 2022 Apr 20.
Artigo em Inglês | MEDLINE | ID: mdl-35460680

RESUMO

ST-segment elevation myocardial infarction (STEMI) remains a significant source of morbidity and mortality worldwide. Despite advances in treatment leading to a significant reduction in the early complications and in-hospital mortality, a significant proportion of STEMI survivors develop heart failure (HF) at follow-up. The classic paradigm of HF after STEMI is one characterized by left ventricular adverse remodeling (LVAR) and encompasses the process of regional and global structural and functional changes that occur in the heart as a consequence of loss of viable myocardium, increased wall stress and neurohormonal activation, and results in HF with reduced ejection fraction (HFrEF). More recently, however, with further improvements in the treatment of STEMI the incidence and entity of LVAR appear to be largely reduced, yet the risk for HF following STEMI is not abolished and remains substantial, identifying a new paradigm by which patients with STEMI present with HF and preserved EF (HFpEF) characterized by reduction of diastolic or systolic reserve independent of LVAR.

19.
JACC Case Rep ; 4(5): 255-261, 2022 Mar 02.
Artigo em Inglês | MEDLINE | ID: mdl-35257098

RESUMO

Ventricular septal rupture (VSR) is a rare but highly lethal (∼60%) mechanical complication of myocardial infarction (MI). Although surgical repair has been the gold standard to correct the structural anomaly, percutaneous closure of the defect may represent a valuable therapeutic alternative, with the advantage of immediate shunt reduction to prevent further hemodynamic deterioration in patients with prohibitive surgical risk. Nonetheless, catheter-based VSR closure has faced certain drawbacks that have hampered its application. We describe a clinical case of postinfarction VSR treated with a percutaneous closure device and discuss the procedure's failure mechanism. (Level of Difficulty: Intermediate.).

20.
Artigo em Inglês | MEDLINE | ID: mdl-35332751

RESUMO

BACKGROUND: Transcatheter aortic valve implantation (TAVI) is emerging a an appealing management strategy for patients with severe aortic stenosis at intermediate, high or exceedingly high risk, but its risk-benefit profile in younger patients is less certain. We aimed at exploring the outlook of patients aged 70 years or less and undergoing TAVI at 2 high-volume Italian institituions. METHODS: We retrospectively collected baseline, imaging, procedural and outcome features of patients with age ≤70 years in whom TAVI was attempted at participating centers between 2012 and 2021. Non-parametric tests and bootstrap resampling were used for inferential purposes. RESULTS: A total of 39 patients were included, out of >3,000 screened with heart team involvement and >1,500 receiving TAVI. Most common or relevant indications for TAVI were reduced life expectancy (eg cardiogenic shock or severe left ventricular systolic dysfunction), chronic obstructive pulmonary disease, morbid obesity, active or recent extra-cardiac cancer, porcelain aorta, neurologic disability, cirrhosis, or prior surgical aortic valve replacement, as well as extreme cachexia, and Hutchinson-Gilford progeria. At least two contemporary high-risk features were present in most cases. Transapical access was used in 5 (12.8%) cases, and a sheathless approach in 15 (38.5%). A variety of devices were used, including both balloon- and selfexpandable devices. Clinical outcomes were satisfactory, despite the high risk profile, at both shortand mid-term, with no in-hospital death, and 5.1% (95% confidence interval 0-12.8%) mortality at a median follow-up of 15 months (minimum 1; maximum 85). Notably, no case of significant valve deterioration requiring reintervention occurred. CONCLUSIONS: In carefully selected patients with 70 years or less of age and prohibitive risk for surgery or reduced life expectancy, TAVI represents a safe option with a favorable mid-term survival and low rate of adverse events.

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