Heparin-Coated versus Uncoated Palmaz-Schatz Stent in Native Coronary Circulation. A Randomized Study with Blind Angioscopic Assessment

2002 ◽  
Vol 25 (5) ◽  
pp. 461-469 ◽  
Author(s):  
S. Kedev ◽  
G. Guagliumi ◽  
O. Valsechi ◽  
M. Tespili

The increasing use of stenting to treat more complex lesions and highly thrombogenic situations still carries higher risk for subacute stent thrombosis. To assess new heparin-coated stents in a more stringent reality, 40 consecutive patients were randomized in 1:1 ratio to receive either heparin-coated (group 1, 25 stents) or uncoated Palmaz-Schatz stents (group 2, 32 stents). The two groups were similar in baseline clinical, pre-and post-procedural angiographic and angioscopic characteristics. High pressure stent deployment without intravascular ultrasound guidance was used. All pts received antiplatelet agents alone. We applied serial angioscopy (baseline and on 7th day) to evaluate thrombus formation and quantitative coronary angiography (QCA) to define late (6 months, n=39, 100% the eligible pts) neointimal regrowth. There was one subacute stent thrombosis with subsequent acute myocardial infarction and death in the uncoated group. Conclusion The implantation of heparin-coated stents in nonselected population is well tolerated and associated with no clinical or angioscopic evidence of new thrombus formation, resulting in favorable long-term clinical and angiographic outcome.

2010 ◽  
Vol 28 (11) ◽  
pp. 1911-1918 ◽  
Author(s):  
Silvia R. Brandalise ◽  
Vitória R. Pinheiro ◽  
Simone S. Aguiar ◽  
Eduardo I. Matsuda ◽  
Rosemary Otubo ◽  
...  

PurposeTo describe event-free survival (EFS) and toxicities in children with low-risk acute lymphoblastic leukemia (ALL) assigned to receive either continuous 6-mercaptopurine (6-MP) and weekly methotrexate (MTX) or intermittent 6-MP with intermediate-dose MTX, as maintenance treatment.Patients and MethodsBetween October 1, 2000, and December 31, 2007, 635 patients with low-risk ALL were enrolled onto Brazilian Childhood Cooperative Group for ALL Treatment (GBTLI) ALL-99 protocol. Eligible children (n = 544) were randomly allocated to receive either continuous 6-MP/MTX (group 1, n = 272) or intermittent 6-MP (100 mg/m2/d for 10 days, with 11 days resting) and MTX (200 mg/m2every 3 weeks; group 2, n = 272).ResultsThe 5-year overall survival (OS) and EFS were 92.5% ± 1.5% SE and 83.6% ± 2.1% SE, respectively. According to maintenance regimen, the OS was 91.4% ± 2.2% SE (group 1) and 93.6% ± 2.1% SE (group 2; P = .28) and EFS 80.9% ± 3.2% SE (group 1) and 86.5% ± 2.8% SE (group 2; P = .089). Remarkably, the intermittent regimen led to significantly higher EFS among boys (85.7% v 74.9% SE; P = .027), while no difference was seen for girls (87.0% v 88.8% SE; P = .78). Toxic episodes were recorded in 226 and 237 children, respectively. Grade 3 to 4 toxic events for groups 1 and 2 were, respectively, 273 and 166 for hepatic dysfunction (P = .002), and 772 and 636 for hematologic episodes (P = .005). Deaths on maintenance were: seven (group 1) and one (group 2).ConclusionThe intermittent use of 6-MP and MTX in maintenance is a less toxic regimen, with a trend toward better long-term EFS. Boys treated with the intermittent schedule had significantly better EFS.


2019 ◽  
Vol 12 (2) ◽  
pp. 59-63
Author(s):  
E. I. Gubarev

Purpose: to evaluate long term effectiveness of a method of restoring the accommodation function of the eye and preventing the onset and progression of myopia and to propose ways to overcome medical requirements that are difficult to meet.Material and methods. The method consisted in prolonged installations of 1 % tropicamide eye drops and permanent optical correction that corresponded to manifest refraction. 48 schoolchildren aged 7–18 with initial myopia or signs of high risk myopia onset were followed up. The subjects were divided into 2 groups of 24 people each. Group 1 consisted of children who followed medical prescriptions and group 2 consisted of those who did not. The two groups were further subdivided into two subgroups. Subgroup 1A included 12 children with the initial positive cycloplegic refraction up to +1.0 D; subgroup 1B included 12 children with the initial negative cycloplegic refraction from -0.5 D. Subgroup 2A (12 children) had negative cycloplegic refraction who regularly failed to receive treatment (optical correction, eyedrop instillations, medical checkups), and subgroup 2B (12 children) had negative cycloplegic refraction who received practically no treatment for myopia. Regular checkups took place 2–3 times a year for 10 years and included measuring visual acuity, manifest and cycloplegic refraction by skiascopy or subjectively, as well as measuring relative accommodation reserve (RAR) according to the author’s own technique. The treatment envisaged permanent optical correction in accordance with manifest refraction until the age of 18 years, combined with courses of tropicamide 1 % instillations for 1 to 3 months two to three times a year. Results. In group 1A, myopia was prevented in all subjects. In group 1B, the progression stopped after several years of treatment. In subgroup 2A and especially subgroup 2B, myopia progressed, over the 10-year follow-up period reaching the figures of 2.5 and 3.5 D, respectively. Conclusion. The long-term efficiency of the proposed method applied to schoolchildren from grade 1 to grade 10 was confirmed. Ways to overcome the difficulties of following medical requirements were proposed.


2020 ◽  
pp. 75-80
Author(s):  
S.A. Lyalkin ◽  
◽  
L.A. Syvak ◽  
N.O. Verevkina ◽  
◽  
...  

The objective: was to evaluate the efficacy of the first line chemotherapy in patients with metastatic triple negative breast cancer (TNBC). Materials and methods. Open randomized study was performed including 122 patients with metastatic TNBC. The efficacy and safety of the first line chemotherapy of regimens АТ (n=59) – group 1, patients received doxorubicine 60 мг/м2 and paclitaxel 175 мг/м2 and ТР (n=63) – group 2, patients received paclitaxel 175 мг/м2 and carboplatin AUC 5 were evaluated. Results. The median duration of response was 9.5 months (4.5–13.25 months) in patients received AT regimen and 8.5 months (4.7–12.25 months), in TP regimen; no statistically significant differences were observed, р=0.836. The median progression free survival was 7 months (95% CI 5–26 months) in group 1 and 7.5 months (95% CI 6–35 months) in group 2, p=0.85. Both chemotherapy regimens (AT and TP) had mild or moderate toxicity profiles (grade 1 or 2 in most patients). No significant difference in gastrointestinal toxicity was observed. The incidence of grade 3–4 neutropenia was higher in patients of group 2 (TP regimen): 42.8% versus 27% (р<0.05). Conclusions. Both regimens of chemotherapy (AT and TP) are appropriate to use in the first line setting in patients with metastatic TNBC. Key words: metastatic triple negative breast cancer, chemotherapy, progression free survival, chemotherapy toxicity.


2021 ◽  
Vol 22 (Supplement_1) ◽  
Author(s):  
M Tesic ◽  
L Travica ◽  
V Giga ◽  
D Trifunovic ◽  
I Jovanovic ◽  
...  

Abstract Funding Acknowledgements Type of funding sources: None. Introduction Since mitral regurgitation (MR) is a very common finding in patients with hypertrophic cardiomyopathy (HCM), the evaluation of the mitral valve anatomy and the degree of MR is of utmost importance in this population. However, data regarding the prognostic value of different degrees of MR in HCM remains scarce. Purpose The aim of this study was to determine whether the presence of a higher degree of MR affects: 1) long term prognosis; 2) clinical and echocardiographic presentation of HCM patients. Material and Methods We included prospectively 102 patients, diagnosed with primary asymmetric HCM. The degree of MR was determined echocardiographicaly according to current recommendations of the American Association of Echocardiography. According to the MR severity, patients were divided into 2 groups: Group 1 (n = 52) with no/trace or mild MR and Group 2 with moderate or moderate to severe MR. All patients had clinical and echocardiographic examination, 24-hour Holter ECG and NT pro BNP analysis performed. The primary outcome was a composite of: 1) HCM related death or sudden death; 2) hospitalization due to acute heart failure; 3) sustained ventricular tachycardia; 4) ischemic stroke. Results Patients with higher MR degree had more frequent chest pain (p = 0.039), syncope (p = 0.041) and NYHA II functional class (p &lt; 0.001). Group 2 patients had mostly obstructive form of HCM (p &lt; 0.001) with more frequent presence of previous atrial fibrillation (AF) (p = 0.032), as well as the new onset of AF (p = 0.014) compared to patients in Group 1. Patients with higher MR degree had significantly more SAM (p &lt; 0.001) resulting in a more frequent eccentric MR jet (p &lt; 0.001), along with calcified mitral annulus (p = 0.007), enlarged left atrial volume index (p &lt; 0.001), and elevated right ventricular pressure (p = 0.001). As a result of higher MR grade, Group 2 had higher E/e" values (p &lt; 0.001), elevated LV filling pressure (lateral E/e’ &gt;10), as well as higher levels of NT pro BNP (p = 0.001). By Kaplan-Meier analysis we demonstrated that the event free survival rate during follow up of median 75 (IQR 48-103) months was significantly higher in Group 1 compared to the Group 2 (79% vs. 46%, p &lt; 0.001), Figure 1. After adjustment for relevant confounders, moderate/moderate to severe MR remained as an independent predictor of adverse outcome (hazard ratio 2.58, 95% CI: 1.08-6.13, p &lt; 0.001). Conclusion Presence of moderate, or moderate to severe MR was associated with poor long-term outcome of HCM patients. These results indicate the importance of an adequate MR assessment and detailed evaluation of the mitral valve anatomy in the prediction of complications and adequate treatment of patients with HCM. Abstract Figure.


2021 ◽  
pp. 1-7
Author(s):  
Constantin Roder ◽  
Uwe Klose ◽  
Helene Hurth ◽  
Cornelia Brendle ◽  
Marcos Tatagiba ◽  
...  

<b><i>Background and Purpose:</i></b> Hemodynamic evaluation of moyamoya patients is crucial to decide the treatment strategy. Recently, CO<sub>2</sub>-triggered BOLD MRI has been shown to be a promising tool for the hemodynamic evaluation of moyamoya patients. However, the longitudinal reliability of this technique in follow-up examinations is unknown. This study aims to analyze longitudinal follow-up data of CO<sub>2</sub>-triggered BOLD MRI to prove the reliability of this technique for long-term control examinations in moyamoya patients. <b><i>Methods:</i></b> Longitudinal CO<sub>2</sub> BOLD MRI follow-up examinations of moyamoya patients with and without surgical revascularization have been analyzed for all 6 vascular territories retrospectively. If revascularization was performed, any directly (by the disease or the bypass) or indirectly (due to change of collateral flow after revascularization) affected territory was excluded based on angiography findings (group 1). In patients without surgical revascularization between the MRI examinations, all territories were analyzed (group 2). <b><i>Results:</i></b> Eighteen moyamoya patients with 39 CO<sub>2</sub> BOLD MRI examinations fulfilled the inclusion criteria. The median follow-up between the 2 examinations was 12 months (range 4–29 months). For 106 vascular territories analyzed in group 1, the intraclass correlation coefficient was 0.784, <i>p</i> &#x3c; 0.001, and for group 2 (84 territories), it was 0.899, <i>p</i> &#x3c; 0.001. Within the total follow-up duration of 140 patient months, none of the patients experienced a new stroke. <b><i>Conclusions:</i></b> CO<sub>2</sub> BOLD MRI is a promising tool for mid- and long-term follow-up examinations of cerebral hemodynamics in moyamoya patients. Systematic prospective evaluation is required prior to making it a routine examination.


2021 ◽  
Vol 28 (Supplement_1) ◽  
Author(s):  
E Belik ◽  
OV Gruzdeva ◽  
YUA Dyleva ◽  
EG Uchasova ◽  
MYU Sinitsky ◽  
...  

Abstract Funding Acknowledgements Type of funding sources: None. Aim to determine the features of adiponectin expression, secretion of adiponectin and its receptors in local fat depots in CVD. Materials and methods The study included 90 patients with СAD (Group 1) and 60 patients with heart defects (Group 2). Adipocytes were isolated from samples of subcutaneous (SAT), epicardial (EAT) and perivascular (PVAT) adipose tissue obtained during CABG or heart valve replacement. The expression of adiponectin was determined by qPCR using TaqManTM Gene Expression Assays (Applied Biosystems, USA) in the ViiA 7 Real-Time PCR System (Applied Biosystems, USA), the levels of expression products was determined using enzyme immunoassay (Bender MedSystems GmbH, Vienna, Austria). The data were analyzed using the statistical software Statistica 9.0. Results EAT adipocytes were characterized by the lowest adiponectin expression relative to adipocytes of other localization both in Group 1 and Group 2. In patients Group 1 adiponectin expression in EAT was reduced relative in SAT and PVAT (by 1.2 and 1.5 times). In Group 2, the adiponectin mRNA in the EAT was lower than in the SAT and PVAT (1.4 and 1.5 times). The expression of adiponectin in EAT in Group 2 exceeded the same indicator in Group 1 by 1.2 times. The maximum expression of adiponectin was observed in the PVAT culture in patients of both groups. For Group 2, this indicator exceeded the values of Group 1 by 1.2 times. The content of adiponectin in the culture EAT was lower than in the SAT, both in Group 1 and Group 2 (by 1.3 and 1.13 times). The level of this indicator in Group 2 was 1.4 times higher than in Group 1. PVAT adipocytes of patients with CAD were characterized by the lowest level of adiponectin secretion in comparison with adipocytes of other localization. The adiponectin level in the PVAT of Group 2 exceeded that of fat stores of other localization and in Group 1 patients by 1.8 times. There were no statistically significant differences in the expression and concentration of adiponectin in the culture of adipocytes of the SAT between the groups of patients. In Group 1, the lowest level of AdipoR1 was found in the adipocyte culture of the PVAT. Noteworthy is the decrease in the level of AdipoR1 in Group 1 compared to the level of Group 2, observed in the SAT and PVAT: 1.3 and 1.5 times. There were no significant differences in the concentration of the AdipoR1 in the EAT, as well as AdipoR2 in all types of AT between the groups of patients. Conclusion: in CVD the EAT is characterized by minimal expression and secretion of adiponectin, regardless of nosology. In CAD despite the high level of expression of adiponectin, the adipocytes of the PVAT were found to have the lowest content in comparison with adipocytes of other localization. Dysregulation of the adiponectin/AdipoR axis is observed in PVAT, which may be due to low expression of adiponectin receptors and long-term processes of its post-translational modification and oligomerization in CAD.


Author(s):  
Eleonora Porcu ◽  
Maria Lucrezia Tranquillo ◽  
Leonardo Notarangelo ◽  
Patrizia Maria Ciotti ◽  
Nilla Calza ◽  
...  

Abstract Purpose The main purpose and research question of the study are to compare the efficacy of high-security closed versus open devices for human oocytes’ vitrification. Methods A prospective randomized study was conducted. A total of 737 patients attending the Infertility and IVF Unit at S.Orsola University Hospital (Italy) between October 2015 and April 2020 were randomly assigned to two groups. A total of 368 patients were assigned to group 1 (High-Security Vitrification™ - HSV) and 369 to group 2 (Cryotop® open system). Oocyte survival, fertilization, cleavage, pregnancy, implantation, and miscarriage rate were compared between the two groups. Results No statistically significant differences were observed on survival rate (70.3% vs. 73.3%), fertilization rate (70.8% vs. 74.9%), cleavage rate (90.6% vs. 90.3%), pregnancy/transfer ratio (32.0% vs. 31.8%), implantation rate (19.7% vs. 19.9%), nor miscarriage rates (22.1% vs. 21.5%) between the two groups. Women’s mean age in group 1 (36.18 ± 3.92) and group 2 (35.88 ± 3.88) was not significantly different (P = .297). A total of 4029 oocytes were vitrified (1980 and 2049 in groups 1 and 2 respectively). A total of 2564 were warmed (1469 and 1095 in groups 1 and 2 respectively). A total of 1386 morphologically eligible oocytes were inseminated by intracytoplasmic sperm injection (792 and 594 respectively, P = .304). Conclusions The present study shows that the replacement of the open vitrification system by a closed one has no impact on in vitro and in vivo survival, development, pregnancy and implantation rate. Furthermore, to ensure safety, especially during the current COVID-19 pandemic, the use of the closed device eliminates the potential samples’ contamination during vitrification and storage.


2020 ◽  
pp. 105566562098023
Author(s):  
Ashwina S. Banari ◽  
Sanjeev Datana ◽  
Shiv Shankar Agarwal ◽  
Sujit Kumar Bhandari

Objectives: To compare nasal and upper airway dimensions in patients with cleft lip and palate (CLP) who underwent nasoalveolar molding (NAM) with those without NAM during infancy using acoustic pharyngometry and rhinometry. Materials and Methods: Eccovision acoustic pharyngometry and rhinometry (Sleep Group Solutions) was used for assessment of mean area and volume of nasal and upper airway in patients with complete unilateral CLP (age range 16-21 years) treated with NAM (group 1, n = 19) versus without NAM (group 2, n = 22). Results: The mean nasal cross-sectional areas and volume were higher in group 1 compared to group 2 on both cleft ( P value <.001) and noncleft side ( P value >.05). The mean area and volume of upper airway were also significantly higher in group 1 compared to group 2 ( P value <.05). Conclusions: Nasoalveolar molding being one of the first interventions in chronology of treatment of patients with CLP, its long-term outcome on nasal and upper airway patency needs to be ascertained. The results of the present study show that the patients with CLP who have undergone NAM during infancy have better improvement in nasal and upper airway patency compared with those who had not undergone NAM procedure. The basic advantages of being noninvasive, nonionizing and providing dynamic assessment of nasal and upper airway patency make acoustic pharyngometry and rhinometry a diagnostic tool of choice to be used in patients with CLP.


Author(s):  
Tsuyoshi Yamabe ◽  
Yanling Zhao ◽  
Paul A Kurlansky ◽  
Suzuka Nitta ◽  
Saveliy Kelebeyev ◽  
...  

Abstract OBJECTIVES Chronic kidney disease (CKD) is prevalent in patients undergoing cardiovascular surgery, and it negatively impacts procedural outcomes; however, its influence on the outcomes of aortic surgery has not been well studied. This study aims to elucidate the importance of CKD on the outcomes of aortic root replacement (ARR). METHODS Patients who underwent ARR between 2005 and 2019 were retrospectively reviewed (n = 882). Patients were divided into 3 groups based on the Kidney Disease: Improving Global Outcomes criteria: Group 1 [estimated glomerular filtration rate (eGFR) ≥ 60 ml/min/1.73 m2, n = 421); Group 2 (eGFR = 30–59 ml/min/1.73 m2, n = 424); and Group 3 (eGFR &lt; 30 ml/min/1.73 m2, n = 37). To reduce potential confounding, a propensity score matching was also performed between Group 1 and the combined group of Group 2 and Group 3. The primary end point was 10-year survival. Secondary end points were in-hospital mortality and perioperative morbidity. RESULTS Severe CKD patients presented with more advanced overall chronic and acute illnesses. Kaplan–Meier analysis showed a significant correlation between CKD stage and 10-year survival (log-rank P &lt; 0.001). The number of events for Group 1 was 15, Group 2 was 49 and Group 3 was 11 in 10 years. Group 3 had significantly higher in-hospital mortality (13.5% vs 3.5% in Group 2 vs 0.7% in Group 1, P &lt; 0.001) and stroke (8.1% vs 7.1% vs 1.2%, P &lt; 0.001) as well as introduction to new dialysis (27.0% vs 5.4% vs 1.7%, P &lt; 0.001). eGFR was shown to be an independent predictor of mortality (hazard ratio, 0.98; 95% confidence interval, 0.96–0.99). Comparison between propensity matched groups showed similar postoperative outcomes, and eGFR was still identified as a predictor of mortality (hazard ratio, 0.97; 95% confidence interval, 0.95–0.99). CONCLUSIONS Higher stage in CKD negatively impacts the long-term survival in patients who are undergoing ARR.


Author(s):  
Gunce Basarir ◽  
Bahar Ozcabi ◽  
Ozden Aksu Sayman ◽  
Hatice Ozturkmen Akay ◽  
Feyza M. Yildiz

Abstract Objectives Non-alcoholic fatty liver disease (NAFLD) is a common obesity-related comorbidity in childhood. In this study, we aimed to evaluate predictors of NAFLD by comparing clinical, endocrine and metabolic findings in obese children with and without hepatosteatosis. Methods Two hundred and eight obese children aged 6–18 years were included. The patients were divided into group 1 (patients with NAFLD, n=94) and group 2 (patients without NAFLD, n=114). Anthropometric measurements, pubertal stage, lipid profiles, fasting glucose and insulin, homeostatic model of assessment for insulin resistance (HOMA-IR), uric acid, total bilirubin, alanine aminotransferase (ALT), blood urea nitrogen, thyroid-stimulating hormone and free thyroxine parameters were compared retrospectively. Results The mean body weight, body mass index (BMI), height, tri-ponderal mass index (TMI), insulin, HOMA-IR, triglyceride, ALT and uric acid values were significantly higher, while high-density lipoprotein-cholesterol (HDL-C) values were significantly lower in group 1. The 70.7% of obese children with hepatosteatosis and 83.9% of those without hepatosteatosis were correctly estimated by parameters including age, gender, ALT, HDL-C, fasting insulin and uric acid values. Conclusions Since obesity-associated hepatosteatosis induces various long-term metabolic impacts in children, early detection is of critical importance. Age, gender, TMI, BMI, ALT, HDL-C, fasting insulin and uric acid values may help to predict the risk of hepatosteatosis. Besides, we assessed whether TMI compared to BMI does not have a better utility in estimating obesity-induced hepatosteatosis in children. This is the first study to show the association between TMI and hepatosteatosis in children.


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