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1.
N Engl J Med ; 2020 Mar 30.
Artigo em Inglês | MEDLINE | ID: mdl-32227755

RESUMO

BACKGROUND: Among patients with stable coronary disease and moderate or severe ischemia, whether clinical outcomes are better in those who receive an invasive intervention plus medical therapy than in those who receive medical therapy alone is uncertain. METHODS: We randomly assigned 5179 patients with moderate or severe ischemia to an initial invasive strategy (angiography and revascularization when feasible) and medical therapy or to an initial conservative strategy of medical therapy alone and angiography if medical therapy failed. The primary outcome was a composite of death from cardiovascular causes, myocardial infarction, or hospitalization for unstable angina, heart failure, or resuscitated cardiac arrest. A key secondary outcome was death from cardiovascular causes or myocardial infarction. RESULTS: Over a median of 3.2 years, 318 primary outcome events occurred in the invasive-strategy group and 352 occurred in the conservative-strategy group. At 6 months, the cumulative event rate was 5.3% in the invasive-strategy group and 3.4% in the conservative-strategy group (difference, 1.9 percentage points; 95% confidence interval [CI], 0.8 to 3.0); at 5 years, the cumulative event rate was 16.4% and 18.2%, respectively (difference, -1.8 percentage points; 95% CI, -4.7 to 1.0). Results were similar with respect to the key secondary outcome. The incidence of the primary outcome was sensitive to the definition of myocardial infarction; a secondary analysis yielded more procedural myocardial infarctions of uncertain clinical importance. There were 145 deaths in the invasive-strategy group and 144 deaths in the conservative-strategy group (hazard ratio, 1.05; 95% CI, 0.83 to 1.32). CONCLUSIONS: Among patients with stable coronary disease and moderate or severe ischemia, we did not find evidence that an initial invasive strategy, as compared with an initial conservative strategy, reduced the risk of ischemic cardiovascular events or death from any cause over a median of 3.2 years. The trial findings were sensitive to the definition of myocardial infarction that was used. (Funded by the National Heart, Lung, and Blood Institute and others; ISCHEMIA ClinicalTrials.gov number, NCT01471522.).

2.
Kardiol Pol ; 78(3): 227-234, 2020 Mar 25.
Artigo em Inglês | MEDLINE | ID: mdl-32041929

RESUMO

BACKGROUND: Pulmonary regurgitation (PR) is the most common late complication in patients after repair of tetralogy of Fallot (TOF). Most patients remain asymptomatic over years, but eventually, the compensatory mechanisms fail, leading to right ventricular (RV) dilation and dysfunction, limited exercise capacity, ventricular arrhythmia, and sudden death. AIMS We aimed to evaluate associations between cardiac magnetic resonance (CMR) parameters and the need for either surgical or percutaneous pulmonary valve replacement (PVR) in asymptomatic patients with significant PR after repair of TOF. METHODS: Of 209 patients with repaired TOF who had undergone a CMR study, we selected 61 asymptomatic patients with moderate­to­severe PR and followed them for up to 4 years (mean [SD], 21.4 [13.7] months). We excluded patients with residual ventricular septal defect, a peak RV outflow tract gradient of 30 mm Hg or higher, or at least moderate tricuspid regurgitation. RESULTS: Receiver operating characteristic curve analyses revealed that the ratio of RV to left ventricular (LV) volume (RV/ LV ratio; threshold >2.4) and PR fraction (PRF; threshold >33%) had acceptable discriminatory capacity to differentiate between patients requiring PVR and those treated conservatively. The Cox proportional hazards regression and the Kaplan-Meier curves revealed that the RV / LV ratio and PRF was significantly associated with the need for PVR. The combination of the RV / LV ratio and PRF provided significant discrimination in terms of survival without PVR (P <0.001; log­rank test for trend). CONCLUSIONS: The RV/ LV ratio and PRF were significantly associated with the need for PVR in asymptomatic patients with isolated moderate­to­severe PR after repair of TOF.

4.
Artigo em Inglês | MEDLINE | ID: mdl-32029383

RESUMO

BACKGROUND: The purpose of this study was to assess the feasibility of low-dose dynamic regadenoson computed tomography perfusion (CTP) protocol, and to determine which parameters provide the best diagnostic yield for the presence and burden of ischemia in reference to the magnetic resonance myocardial perfusion imaging (MR MPI). METHODS: Fifty six patients with ≥1 intermediate (50-90%) coronary artery stenosis on CTA underwent dynamic stress CTP and MR MPI. The distribution of contrast agent in CTP was represented for each myocardial segment as either absolute or indexed: myocardial blood flow (MBF), myocardial blood volume (MBV), perfused capillary blood volume (PCBV), peak value (PV), time to peak (TTP), respectively. RESULTS: Of 56 patients (25 females, 63.5 ± 8.5y), 15 (27%) were diagnosed with reversible ischemia and 3 (5%) with fixed ischemia on the MR MPI. The median radiation dose for dynamic CTP scan was 352.00 [276.4-496.6] mGy*cm. The optimal cut-off point for the prediction of reversible ischemia on MR MPI for the absolute parameters were: MBF ≤156.49 (AUC=0.899), MBV ≤15.06 (AUC=0.901), PCBV ≤7.90 (AUC=0.880), PV ≤ 88.30 (AUC=0.766), TTP ≥22.58 (AUC=0.595); and for the indexed: indexed MBF ≤0.78 (AUC=0.926), indexed MBV ≤0.81 (AUC=0.924), indexed PCBV ≤0.70 (AUC=0.894); indexed PV ≤ 0.79 (AUC=0.869), indexed TTP ≤0.87 (AUC=0.685). The best parameters for ischemia detection were indexed MBF and indexed MBV, with sensitivities 91% and 89%, specificities 97% and 96%, NPV 99% and 99%, PPV 76% and 69%, and accuracies 96% and 95%, respectively. In per patient analysis, indexed MBF correlated significantly better with the ischemia burden than any of the absolute parameters (p < 0.01 for all comparisons). CONCLUSIONS: Regadenoson dynamic CTP using low-dose protocol is feasible while maintaining high diagnostic accuracy. The best diagnostic value may be provided by indexed parameters, of which indexed MBF and indexed MBV may provide best incremental value in identification of the presence and burden of ischemia.

5.
Nutr Metab Cardiovasc Dis ; 30(1): 56-59, 2020 Jan 03.
Artigo em Inglês | MEDLINE | ID: mdl-31558416

RESUMO

BACKGROUND AND AIMS: Aim of this study involved assessment of the intensive intervention concerning lifestyle based on the DASH diet model on plasma concentration of CXCL4 chemokine among patients with coronary atherosclerosis. METHODS AND RESULTS: The Dietary Intervention to Stop Coronary Atherosclerosis in Computed Tomography Study randomized patients with stable CAD to an interventional group (n = 41), where DASH diet was implemented and the control group (n = 40) without dietary intervention. Dietary counselling was provided to DASH group during all 6 control visits within 6 months of observation. During the study, body weight and body composition were controlled using the bioimpedance method. CXCL4 concentration was determined with the use of ELISA test. Within the DASH group, a significant decrease in body weight, a decrease in high sensitivity C-reactive protein concentration (-0.32 ± 2.8 mg/l; p < 0.05), as well as a decrease in CXCL4 concentration (-3.35 ± 3.4 ng/ml; p < 0.0001) were observed. Occurring changes were not statistically significant within the control group. CONCLUSIONS: DASH diet lessens CXCL4 concentration among patients with a stable CAD, however, further research is necessary in order to confirm aforementioned results and evaluate the impact on atherosclerotic plaque. THIS TRIAL WAS REGISTERED AT: www.clinicaltrials.gov as NCT02571803.

7.
Kardiol Pol ; 77(11): 1094-1105, 2019 Nov 22.
Artigo em Inglês | MEDLINE | ID: mdl-31723115

RESUMO

The presence of patent foramen ovale (PFO) was found to be associated with a number of medical conditions, including embolic stroke and recurrent transient neurological defects. The closure of PFO remains controversial; however, in recently published guidelines from the European Association of Percutaneous Cardiovascular Interventions in collaboration with 7 other European societies, which extensively refer to the latest randomized clinical trials, it is explicitly recommended to perform percutaneous PFO closure in the prevention of recurrent thromboembolic events. In connection with the above facts and expected increasing number of PFO closure procedures, the joint expert group of the Association of Cardiovascular Interventions and the Grown­Up Congenital Heart Disease Section of the Polish Cardiac Society developed the following consensus opinion in order to standardize the principles of diagnosis, indications, methods of performing procedures, and postoperative care in relation to Polish conditions and experiences.

8.
Circ Cardiovasc Qual Outcomes ; 12(11): e006002, 2019 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-31718297

RESUMO

BACKGROUND: Risk factor control is the cornerstone of managing stable ischemic heart disease but is often not achieved. Predictors of risk factor control in a randomized clinical trial have not been described. METHODS AND RESULTS: The ISCHEMIA trial (International Study of Comparative Health Effectiveness with Medical and Invasive Approaches) randomized individuals with at least moderate inducible ischemia and obstructive coronary artery disease to an initial invasive or conservative strategy in addition to optimal medical therapy. The primary aim of this analysis was to determine predictors of meeting trial goals for LDL-C (low-density lipoprotein cholesterol, goal <70 mg/dL) or systolic blood pressure (SBP, goal <140 mm Hg) at 1 year post-randomization. We included all randomized participants in the ISCHEMIA trial with baseline and 1-year LDL-C and SBP values by January 28, 2019. Among the 3984 ISCHEMIA participants (78% of 5179 randomized) with available data, 35% were at goal for LDL-C, and 65% were at goal for SBP at baseline. At 1 year, the percent at goal increased to 52% for LDL-C and 75% for SBP. Adjusted odds of 1-year LDL-C goal attainment were greater with older age (odds ratio [OR], 1.11 [95% CI, 1.03-1.20] per 10 years), lower baseline LDL-C (OR, 1.19 [95% CI, 1.17-1.22] per 10 mg/dL), high-intensity statin use (OR, 1.30 [95% CI, 1.12-1.51]), nonwhite race (OR, 1.32 [95% CI, 1.07-1.63]), and North American enrollment compared with other regions (OR, 1.32 [95% CI, 1.06-1.66]). Women were less likely than men to achieve 1-year LDL-C goal (OR, 0.68 [95% CI, 0.58-0.80]). Adjusted odds of 1-year SBP goal attainment were greater with lower baseline SBP (OR, 1.27 [95% CI, 1.22-1.33] per 10 mm Hg) and with North American enrollment (OR, 1.35 [95% CI, 1.04-1.76]). CONCLUSIONS: In ISCHEMIA, older age, male sex, high-intensity statin use, lower baseline LDL-C, and North American location predicted 1-year LDL-C goal attainment, whereas lower baseline SBP and North American location predicted 1-year SBP goal attainment. Future studies should examine the effects of sex disparities, international practice patterns, and provider behavior on risk factor control.

9.
Artigo em Inglês | MEDLINE | ID: mdl-31780142

RESUMO

BACKGROUND: Clinical and safety outcomes of the strategy employing coronary computed tomography angiography (CCTA) as the first-choice imaging test have recently been demonstrated in the recently published CAT-CAD randomized, prospective, single-center study. Based on prospectively collected data in this patient population, we aimed to perform an initial cost analysis of this approach. METHODS: 120 participants of the CAT-CAD trial (age:60.6 ±â€¯7.9 years, 35% female) were included in the analysis. We analyzed medical resource use during the diagnostic and therapeutic episode of care. We prospectively estimated the cumulative cost for each strategy by multiplying the number of resources by standardized costs in accordance to medical databases and the 2015 Procedural Reimbursement Payment Guide. RESULTS: The total cost of coronary artery disease (CAD) diagnosis was significantly lower in the CCTA group as compared to the direct invasive coronary angiography (ICA) group ($50,176 vs $137,032) with corresponding per-patient cost of $836 vs $2,284, respectively. Similarly, the entire diagnostic and therapeutic episode of care was significantly less expensive in the CCTA group ($227,622 vs $502,827) with corresponding per-patient cost of $4630 vs $8,380, respectively. Overall, the application of CCTA as a first-line diagnostic test in stable patients with indications to ICA resulted in a 63% reduction of CAD diagnosis costs and a 55% reduction composite of diagnosis and treatment costs during 90-days follow-up. CONCLUSIONS: Application of CCTA as the first-line anatomic test in patients with suspected significant CAD decreased the total costs of diagnosis. This is likely attributable to reduced numbers of invasive tests and hospitalisations. Initial cost analysis of the CAT-CAD randomized trial suggests that this approach may provide significant cost savings for the entire health system.

10.
Am J Cardiol ; 124(11): 1741-1747, 2019 Dec 01.
Artigo em Inglês | MEDLINE | ID: mdl-31590911

RESUMO

After transcatheter aortic valve implantation (TAVI) there is consistently identified decrease in platelets accompanied by a leucocyte (white blood cell, WBC) increase. We aimed to analyze the prognostic value of early platelet and WBC count changes (thromboinflammatory response) after successful TAVI. Among 432 consecutive patients [median 83.0 years of age, 63.4% women], platelets and WBCs were measured before and for 7 days post-TAVI. Follow-up was 36.9 (21.4 to 48.0) months. Platelet decrease (∆%Platelet-max) and parallel WBC increase (∆%WBC-max) were seen at days 1 to 3. Both ∆%Platelet-max ≤-37.6% and ∆%WBC-max >72.5% predicted mortality (area under the curve = 0.569 and area under the curve = 0.626). The 30-day and 1-year mortality (13.1% and 26.2%) were highest among 28% patients with a greater decrease in platelets and a greater increase in WBCs; intermediate (0.9% and 12.3%) among 52.5% patients with either a greater decrease in platelets or a greater increase in WBCs, but not both; and lowest (0% and 6.6%) among 19.5% patients with a lesser decrease in platelets and a lesser increase in WBCs (p <0.001). Estimated 4-year mortality rates were 53.7% versus 36.2% versus 24.5%, respectively, p <0.001. Bleeding, surgical wounds, acute kidney, and brain injury predicted a more intense thromboinflammatory response, whereas use of the newer generations had the opposite effect. In conclusion, substantial thromboinflammatory response identified after successful TAVI predicts a higher long-term mortality.

11.
Postepy Kardiol Interwencyjnej ; 15(3): 308-313, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31592254

RESUMO

Introduction: Growing role of coronary computed tomography angiography (CTA) as a diagnostic tool in patients with suspected coronary artery disease (CAD) calls for better recognition of its value in clinical decision making as compared to the gold standard of invasive coronary angiography (ICA). Aim: To assess the diagnostic value of quantitative coronary computed tomography angiography (QCT) as compared to quantitative coronary angiography (QCA) for the prediction of coronary revascularization. Material and methods: In this prospective observational study we included 100 patients who underwent ICA following CTA. Quantitative diameter stenosis analysis (qCTA) was performed with Syngo.via (Siemens Medical Systems) software by an experienced investigator blinded to results of ICA. Quantitative Coronary Angiography (QCA) was chosen to define %DS in a repetitive manner. ICA images were submitted to Qangio XA (Medis, Leiden, The Netherlands) software for QCA analysis. Results: Eighty out of 400 analysed vessels were revascularized. Per-vessel diagnostic accuracy, sensitivity, specificity, PPV an NPV were 80%, 98%, 73%, 48% and 99% for QCT and 81%, 99%, 73%, 48% and 100% for QCA, respectively, for the prediction of revascularization. AUC was similar: 0.88 for QCT and 0.89 for QCA (p = NS). Conclusions: These real-world data support the concept that CTA is as precise in prediction of coronary revascularization as ICA. This may add to the discussion about CTA having the potential to replace ICA for diagnosing vessels qualified for intervention, reserving the invasive diagnostic approach for those with the highest probability of revascularization.

12.
Postepy Kardiol Interwencyjnej ; 15(3): 314-320, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31592255

RESUMO

Introduction: Despite their significance, the prevalence and the incidence of vulnerable plaques in coronary arteries, as well as their natural history, remain poorly known. Aim: To evaluate the prevalence, incidence and evolution of napkin-ring sign (NRS), and to establish factors associated with its presence, progression, or regression, in patients with suspected coronary artery disease (CAD). Material and methods: The study is based on a single-center prospective registry. Eighty-nine patients with suspected CAD underwent two computed tomography angiography (CTA) examinations within an interval of at least 24 months. High-risk plaque was defined by the presence of a low-attenuation area adjacent to the coronary lumen, surrounded by a ring of higher attenuation - NRS. Results: At the baseline 53 NRS were observed in 22 (25%) patients, 7 (8%) patients had single NRS and 15 (17%) had multiple NRS. After the follow-up period, there were 68 NRS in 32 patients. In 18 patients progression was observed with 23 additional NRS. Presence of single NRS and diabetes were independent predictors of NRS progression. Conclusions: The number of NRS plaque tends to increase over time in patients with suspected CAD. The progression may be predicted by the presence of diabetes or single NRS.

18.
J Cardiovasc Comput Tomogr ; 13(1): 62-67, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-30309764

RESUMO

BACKGROUND: CTA based FFR, a software based application, enhances diagnostic value of coronary computed tomography angiography (CTA) examination. However it remains unknown whether it improves accuracy over the gold standard of invasive coronary angiography (ICA) in predicting functionally significant coronary stenosis. The aim of our study was to compare diagnostic accuracies of coronary CTA, CTA based FFR, and ICA, with invasive FFR as the reference standard in patients with intermediate stenosis on CTA. METHODS: 96 intermediate stenoses (50-90%) from 90 subjects, with intermediate pre-test probability of CAD, who underwent coronary CTA were analyzed. Each patient had subsequent ICA with FFR. CTA based FFR (cFFR v2.1, Siemens) analysis was performed on-site. The stenoses with invasive FFR≤0.8 were considered hemodynamically significant. RESULTS: 41/96 stenoses were hemodynamically significant (FFR≤0.8). While the area under ROC curves (AUC) for identification of significant stenosis evaluated on QCA (0.653), visual ICA (0.652), qCTA (0.690) and visual CTA (0.660) did not significantly differ, the AUC for CTA based FFR (0.835) was significantly higher (p = 0.004, p = 0.004, p = 0.010, p = 0.007, respectively). The accuracies of CTA based FFR, qCTA and QCA were 76%, 63% and 58% respectively. CONCLUSION: Our results suggest that diagnostic potential of routine coronary CTA, augmented with CTA based FFR analysis, is superior to ICA in patients with intermediate stenosis.


Assuntos
Angiografia por Tomografia Computadorizada , Angiografia Coronária/métodos , Doença da Artéria Coronariana/diagnóstico por imagem , Estenose Coronária/diagnóstico por imagem , Reserva Fracionada de Fluxo Miocárdico , Idoso , Doença da Artéria Coronariana/fisiopatologia , Estenose Coronária/fisiopatologia , Feminino , Humanos , Aprendizado de Máquina , Masculino , Pessoa de Meia-Idade , Valor Preditivo dos Testes , Prognóstico , Estudos Prospectivos , Interpretação de Imagem Radiográfica Assistida por Computador , Reprodutibilidade dos Testes , Índice de Gravidade de Doença
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