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1.
Int J Nanomedicine ; 16: 7775-7799, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-34853513

RESUMO

Background: Mizolastine (MZL) is a dual-action nonsedating topical antihistamine anti-inflammatory agent that is used to relieve allergic conditions, such as rhinitis and conjunctivitis. Solid lipid nanoparticles (SLNs) are advanced delivery system in ophthalmology, with the merits of increasing the corneal drug absorption and hence improved bioavailability with the objective of ocular drug targeting. Methods: First, MZL was formulated as MZL-SLNs by hot homogenization/ultrasonication adopting a 32 full factorial design. Solid-state characterization, in vitro release, and stability studies have been performed. Then, the optimized MZL-SLNs formula has been incorporated into ocular hydrogels using 1.5% w/v Na alginate and 5% w/v polyvinylpyrrolidone K90. The gels were evaluated via in vitro release as well as in vivo studies by applying allergic conjunctivitis congestion in a rabbit-eye model. Results: The optimized formula (F4) was characterized by the highest entrapment efficiency (86.5±1.47%), the smallest mean particle size (202.3±13.59 nm), and reasonable zeta potential (-22.03±3.65 mV). Solid-state characterization of the encapsulation of MZL in SLNs was undertaken. In vitro results showed a sustained release profile from MZL-SLNs up to 30 hours with a non-Fickian Higuchi kinetic model. Stability studies confirmed immutability of freeze-dried MZL-SLNs (F4) upon storage for 6 months. Finally, hydrogel formulations containing MZL-SLNs, proved ocular congestion disappearance with completely repaired conjunctiva after 24 hours. Moreover, pretreatment with MZL-SLNs-loaded hydrogel imparted markedly decreased TNF-α and VEGF-expression levels in rabbits conjunctivae compared with post-treatment with the same formula. Conclusion: MZL-SLNs could be considered a promising stable sustained-release nanoparticulate system for preparing ocular hydrogel as effective antiallergy ocular delivery systems.

3.
Circ Cardiovasc Qual Outcomes ; 14(11): e008055, 2021 11.
Artigo em Inglês | MEDLINE | ID: mdl-34666500

RESUMO

BACKGROUND: In clinical trials, the optimal method of adjudicating revascularization events as clinically or nonclinically indicated (CI) is to use an independent Clinical Events Committee (CEC). However, the Academic Research Consortium-2 currently recommends using physiological assessment. The level of agreement between these methods of adjudication remains unknown. METHODS: Data for all CEC adjudicated revascularization events among the 3457 patients followed-up for 2-years in the TALENT trial, and 3-years in the DESSOLVE III, PIONEER, and SYNTAX II trial were collected and readjudicated according to a quantitative flow ratio (QFR) analysis of the revascularized vessels, by an independent core lab blinded to the results of the conventional CEC adjudication. The κ statistic was used to assess the level of agreement between the 2 methods. RESULTS: In total, 351 CEC-adjudicated repeat revascularization events occurred, with retrospective QFR analysis successfully performed in 212 (60.4%). According to QFR analysis, 104 events (QFR ≤0.80) were adjudicated as CI revascularizations and 108 (QFR >0.80) were not. The agreement between CEC and QFR based adjudication was just fair (κ=0.335). Between the 2 methods of adjudication, there was a disagreement of 26.4% and 7.1% in CI and non-CI revascularization, respectively. Overall, the concordance and discordance rates were 66.5% and 33.5%, respectively. CONCLUSIONS: In this event-level analysis, QFR based adjudication had a relatively low agreement with CEC adjudication with respect to whether revascularization events were CI or not. CEC adjudication appears to overestimate CI revascularization as compared with QFR adjudication. Direct comparison between these 2 strategies in terms of revascularization adjudication is warranted in future trials. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: TALENT trial: NCT02870140, DESSOLVE III trial: NCT02385279, SYNTAX II: NCT02015832, and PIONEER trial: NCT02236975.


Assuntos
Doença da Artéria Coronariana , Estenose Coronária , Angiografia Coronária , Vasos Coronários , Humanos , Valor Preditivo dos Testes , Ensaios Clínicos Controlados Aleatórios como Assunto , Estudos Retrospectivos
4.
J Clin Med ; 10(20)2021 Oct 09.
Artigo em Inglês | MEDLINE | ID: mdl-34682750

RESUMO

The new-generation ACURATE neo2 system was commercially released in September 2020. In this study, we sought to compare the aortic regurgitation (AR) severity of the ACURATE neo2 versus the ACURATE neo transcatheter heart valve, using quantitative videodensitometric angiography (qAR). This is a retrospective, Corelab analysis of final post-transcatheter aortic valve implantation (TAVI) aortograms of patients treated with the ACURATE neo2 and ACURATE neo systems. The ACURATE neo2 cohort comprised consecutive patients treated between September 2020 and January 2021 at two centers. The ACURATE neo cohort included consecutive patients treated before September 2020. Our primary objective was to compare AR severity on qAR following TAVI with ACURATE neo2 and ACURATE neo. Out of 401 aortograms, 228 (56.9%) were analyzable, with 120 in the ACURATE neo2 cohort, and 108 in the ACURATE neo cohort. The mean AR fraction was 4.4 ± 4.8% in the neo2 cohort, and 9.9 ± 8.2% in the neo cohort (p < 0.001). Furthermore, moderate or severe AR (qAR > 17%) was detected in 2 aortograms (1.7%) in the neo2 cohort and 15 aortograms (13.9%) in the neo cohort (p < 0.001). Quantitative aortography shows a lower rate of moderate or severe paravalvular AR in what is the first European experience of the new-generation, self-expanding ACURATE neo2 when compared to the first-generation ACURATE neo. Moreover, aortographic data need to be correlated and compared to Core Laboratory-adjudicated 30-day echocardiographic data.

5.
Drug Deliv ; 28(1): 1795-1809, 2021 Aug 24.
Artigo em Inglês | MEDLINE | ID: mdl-34470551

RESUMO

Nizatidine (NIZ), a histamine H2-receptor antagonist, is soluble and stable in the stomach, however, it exhibits a short half-life and a rapid clearance. Therefore, chitosan (CS) and polyethylene oxide (PEO) nanofibers (NFs) at different weight ratios were prepared by electrospinning and characterized. The selected uncrosslinked and glutaraldehyde-crosslinked NFs were investigated regarding floating, solid-state characteristics, in vitro release, and in vitro cytotoxicity. The cytoprotective activity against ethanol-induced gastric injury in rats was evaluated through macroscopical, histopathological, immunohistochemical, and oxidative stress examinations. NFs based on 8:2 CS:PEO exhibited the smallest diameter (119.17 ± 22.05 nm) and the greatest mucoadhesion (22.82 ± 3.21 g/cm2), so they were crosslinked with glutaraldehyde. Solid-state characterization indicated polymers interaction, a successful crosslinking, and NIZ dispersion in NFs. Crosslinking maintained swollen mats at pH 1.2 (swelling% = 29.47 ± 3.50% at 24 h), retarded their erosion at pH 6.8 (swelling%= 84.64 ± 4.91% vs. 25.40 ± 0.79% for the uncrosslinked NFs at 24 h), augmented the floating up to 24 h vs. 10 min for the uncrosslinked NFs at pH 1.2 and prolonged the drug release (%drug released ≥ 93% at 24 h vs. 4 and 5 h for the uncrosslinked NFs at pHs 1.2 and 6.8, respectively). The viability of Caco-2 cells ≥ 86.87 ± 6.86% revealed NFs biocompatibility and unreacted glutaraldehyde removal. Crosslinking of 8:2 CS:PEO NFs potentiated the antiulcer activity (38.98 vs. 8.67 for the uncrosslinked NFs) as well as it preserved the gastric wall architecture, COX-2 expression, and oxidative stress markers levels of the normal rats.

7.
Glob Heart ; 16(1): 54, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-34381675

RESUMO

Objectives: We aimed to compare the quantitative angiographic aortic regurgitation (AR) into the left ventricular out flow tract (LVOT-AR) of five different types of transcatheter self-expanding valves and to investigate the impact of the learning curve on post-TAVR AR. Background: Quantitative video densitometric aortography is an objective, accurate, and reproducible tool for assessment of AR following TAVR. Methods and results: This retrospective academic core-lab analysis, analyzed 1150 consecutive cine aortograms performed immediately post-TAVR. Quantitative angiographic AR of post-procedural aortography in 181 consecutive patients, who underwent TAVR with the Venus A-valve in a single Chinese center, were compared to the results of Evolut Pro, Evolut R, CoreValve, (Medtronic, Dublin, Ireland) and Acurate Neo (Boston Scientific, Massachusetts, US) transcatheter heart valves (THVs), from a previously published pooled database. Among the 181 aortograms of patients treated with the Venus A-Valve, 113 (62.4%) were analyzable for quantitative assessment of AR. The mean LVOT-AR was 8.9% ± 10.0% with 14.2% of patients having moderate or severe AR in the Venus A-valve group. No significant difference in mean LVOT-AR was observed between Evolut Pro, Evolut R, Acurate Neo, and Venus A-valve. The incidence of LVOT-AR >17%, which correlates with echocardiographic derived ≥ moderate AR, with the Evolut Pro was lower than with the Venus A-valve (5.3% vs. 14.2%, p = 0.034), but was not different from the Evolut R (5.3% vs. 8.8%, p = 0.612), or the Acurate Neo (5.3% vs. 11.3% p = 0.16) systems. A landmark analysis after recruitment of the first half of patients treated with the Venus A valve (N = 56), showed a significantly lower mean LVOT-AR in the second half of the series (11.3% ± 11.9% vs. 6.5% ± 7.1%, p = 0.011). The incidence of LVOT-AR >17% in the latest 57 cases was also numerically lower (7.0% vs. 21.4%, p = 0.857) and compared favorably with the best in class of the self-expanding valves. Conclusion: The Venus A-valve has comparable mean LVOT-AR to other self-expanding valves but has a higher rate of moderate or severe AR than the Evolut Pro THV. However, after completion of a learning phase, results improved and compared favorably with the best in class of the commercially available self-expanding valves. These findings should be confirmed in prospective randomized comparisons of AR between different THVs.


Assuntos
Insuficiência da Valva Aórtica , Estenose da Valva Aórtica , Próteses Valvulares Cardíacas , Substituição da Valva Aórtica Transcateter , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/cirurgia , Insuficiência da Valva Aórtica/diagnóstico por imagem , Insuficiência da Valva Aórtica/epidemiologia , Insuficiência da Valva Aórtica/etiologia , Estenose da Valva Aórtica/cirurgia , China/epidemiologia , Humanos , Curva de Aprendizado , Estudos Prospectivos , Desenho de Prótese , Estudos Retrospectivos , Substituição da Valva Aórtica Transcateter/efeitos adversos , Resultado do Tratamento
8.
EuroIntervention ; 2021 Jul 20.
Artigo em Inglês | MEDLINE | ID: mdl-34278989

RESUMO

BACKGROUND: The Xeltis biorestorative transcatheter heart valve (BTHV) leaflets are made from an eletrospun bioabsorbable supramolecular polycarbonate-urethane and are mounted on a self-expanding nitinol frame. Acute hemodynamic performance of this BTHV was favorable. AIMS: We sought to demonstrate preclinical feasibility of a novel BTHV by evaluating the hemodynamic performances of 5 pilot valve designs up to 12 months in a chronic ovine model. METHODS: Five design iterations (A, B, B', C, and D) of the BTHV were transapically implanted in 46 sheep; chronic data were available in 39 animals. Assessments were performed at implantation, 3-, 6-, and 12-months including quantitative aortography, echocardiography, and histology. RESULTS: At 12-months, greater than or equal to moderate AR on echocardiography was seen in 0%, 100%, 33.3%, 100%, and 0% in the iterations A, B, B', C, and D, respectively. Furthermore, transprosthetic mean gradients on echocardiography was 10.0±2.8mmHg, 19.0±1.0mmHg, 8.0±1.7mmHg, 26.8±2.4mmHg, and 11.2±4.1mmHg, and effective orifice area was 0.7±0.3cm2, 1.1±0.3cm2, 1.5±1.0cm2, 1.5±0.6cm2, and 1.0±0.4cm2 in the iterations A, B, B', C, and D, respectively. On pathological evaluation, the iteration D demonstrated generally intact leaflets and advanced tissue coverage, while different degrees of structural deterioration were observed in the other design iterations. CONCLUSIONS: Several leaflet material iterations were compared for potential to demonstrate endogenous tissue restoration in an aortic valve in-vivo. The most promising iteration showed intact leaflets and acceptable hemodynamic performance at 12 months, illustrating the potential of BTHV.

9.
JACC Cardiovasc Interv ; 14(14): 1523-1534, 2021 07 26.
Artigo em Inglês | MEDLINE | ID: mdl-34217623

RESUMO

OBJECTIVES: This study aimed to validate a dedicated software for quantitative videodensitometric angiographic assessment of mitral regurgitation (QMR). BACKGROUND: Quantitative videodensitometric aortography of aortic regurgitation using the time-density principle is a well-documented technique, but the angiographic assessment of mitral regurgitation (MR) remains at best semi-quantitative and operator dependent. METHODS: Fourteen sheep underwent surgical mitral valve replacement using 2 different prostheses. Pre-sacrifice left ventriculograms were used to assess MR fraction (MRF) using QMR and MR volume (MRV). In an independent core lab, the CAAS QMR 0.1 was used for QMR analysis. In vitro MRF and MRV were assessed in a mock circulation at a comparable cardiac output to the in vivo one by thermodilution. The correlations and agreements of in vitro and in vivo MRF, MRV, and interobserver reproducibility for QMR analysis were assessed using the averaged cardiac cycles (CCs). RESULTS: In vivo derived MRF by QMR strongly correlated with in vitro derived MRF, regardless of the number of the CCs analyzed (best correlation: 3 CCs y = 0.446 + 0.994x; R = 0.784; p =0.002). The mean absolute difference between in vitro derived MRF and in vivo derived MRF from 3 CCs was 0.01 ± 4.2% on Bland-Altman analysis. In vitro MRV and in vivo MRV from 3 CCs were very strongly correlated (y = 0.196 + 1.255x; R = 0.839; p < 0.001). The mean absolute difference between in vitro MRV and in vivo MRV from 3 CCs was -1.4 ± 1.9 ml. There were very strong correlations of in vivo MRF between 2 independent analysts, regardless of the number of the CCs. CONCLUSIONS: In vivo MRF using the novel software is feasible, accurate, and highly reproducible. These promising results have led us to initiate the first human feasibility study comprising patients undergoing percutaneous mitral valve edge-to-edge repair.


Assuntos
Insuficiência da Valva Aórtica , Insuficiência da Valva Mitral , Animais , Insuficiência da Valva Aórtica/diagnóstico por imagem , Insuficiência da Valva Aórtica/cirurgia , Humanos , Insuficiência da Valva Mitral/diagnóstico por imagem , Insuficiência da Valva Mitral/cirurgia , Próteses e Implantes , Reprodutibilidade dos Testes , Ovinos , Resultado do Tratamento
10.
Int J Cardiol ; 338: 168-173, 2021 09 01.
Artigo em Inglês | MEDLINE | ID: mdl-34147554

RESUMO

BACKGROUND: Appropriate size selection of transcatheter heart valves (THVs) is fundamental to reduce transcatheter aortic valve implantation (TAVI) related complications, particularly paravalvular aortic regurgitation, new permanent pacemaker implantation, and annular rupture. We sought to investigate the frequency of operator selection of intermediate-size balloon-expandable Myval THVs (Meril Life Sciences Pvt. Ltd., India) for TAVI in a real-world dataset. METHODS: In this retrospective survey of patients treated with TAVI using the Myval THV, 20, 23, 26, and 29 mm are conventional-size THVs, 21.5, 24.5 and 27.5 mm are intermediate-size THVs, and 30.5 and 32 mm are extra-large THVs. Operator size selection for implantation was based on multislice computed tomography (MSCT) derived aortic-root dimensions. RESULTS: A total of 1115 patients underwent Myval THV implantation in 27 countries worldwide. The Myval intermediate-size THVs were used in 468 (42.0%) patients. MSCT data were available in 562 patients. There was no statistical difference between the Intermediate/Upsized and Appropriately sized groups or Intermediate/Downsized and Appropriately sized groups in terms of different variables measured with MSCT except for annular dimensions and degree of calcification. CONCLUSIONS: Intermediate-size Myval balloon-expandable THVs are used in nearly half of all cases in contemporary real-world TAVI practice, addressing the unmet need of TAVI operators for a more calibrated THV choice. Our hypothesis should be tested in randomized prospective studies currently initiated in Europe, including clinical outcomes of patients treated with both conventional- and intermediate-size THVs.


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 por imagem , Estenose da Valva Aórtica/cirurgia , Europa (Continente) , Humanos , Índia , Estudos Prospectivos , Desenho de Prótese , Estudos Retrospectivos , Substituição da Valva Aórtica Transcateter/efeitos adversos , Resultado do Tratamento
11.
Breast ; 59: 67-75, 2021 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-34171619

RESUMO

BACKGROUND: Human epidermal growth factor receptor-2 (HER2) is overexpressed in 20-25% of breast cancers. Complete eradication of disease following neoadjuvant therapies and chemotherapy has been referred to as pathological complete response (pCR). AIMS: To determine clinicopathological predictors of pCR to neoadjuvant therapies and to evaluate pCR as a surrogate to enhanced survival. METHODS: Consecutive female patients with HER2 positive (HER+) breast cancer managed surgically in a single institution between 2005 and 2015 were included. Descriptive statistics and binary logistic regression were used to determine predictors of pCR. Appraisal of pCR as a predictor of survival was performed using Kaplan-Meier curves and Cox regression analysis. RESULTS: 451 patients were included with a mean age of 56.6 ± 13.4 years (range 23-95). Disease-free (DFS) and overall survival (OS) was 82.3% (371/451) and 82.6% (376/451) respectively with a median follow-up of 108.0 months (range 3-184.0). 118 were treated in the neoadjuvant setting (26.2%): tumour size <50 mm (Odds Ratio (OR): 12.156, P = 0.023) and progesterone receptor negativity (OR: 2.762, P = 0.008) independently predicted breast pCR, while ductal carcinoma (OR: 3.203, P = 0.030) and grade 3 disease (OR: 2.788, P = 0.018) predicted axillary pCR. Both breast and axillary pCR predicted enhanced DFS (Hazard Ratio (HR): 0.470 & HR: 0.449) and OS (HR: 0.383 & HR: 0.307). Axillary pCR independently predicted improved OS (HR: 0.326). CONCLUSION: pCR is sensitive biomarker and surrogate to survival outcomes in HER2+ breast cancer. Patients likely to achieve pCR may be predicted from traditional clinicopathological characteristics and molecular parameters.


Assuntos
Neoplasias da Mama , Carcinoma Ductal de Mama , Receptor ErbB-2 , Adulto , Idoso , Idoso de 80 Anos ou mais , Protocolos de Quimioterapia Combinada Antineoplásica , Neoplasias da Mama/tratamento farmacológico , Carcinoma Ductal de Mama/tratamento farmacológico , Intervalo Livre de Doença , Feminino , Humanos , Pessoa de Meia-Idade , Terapia Neoadjuvante , Prognóstico , Estudos Retrospectivos , Adulto Jovem
14.
Catheter Cardiovasc Interv ; 98(4): E513-E522, 2021 10.
Artigo em Inglês | MEDLINE | ID: mdl-34000088

RESUMO

OBJECTIVES: This study aimed to assess the predictive ability of the Global Registry of Acute Coronary Events (GRACE) risk score 2.0 in contemporary acute coronary syndrome (ACS) patients, and its relation to antiplatelet strategies. BACKGROUND: The predictive value of the GRACE risk score in the contemporary ACS cohort and the appropriate antiplatelet regimen according to the risk remain unclear. METHODS: This is a subgroup analysis of the all-comers, randomized GLOBAL LEADERS trial, comparing ticagrelor monotherapy versus conventional dual-antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI). The GRACE risk score 2.0 with 1-year mortality prediction was implemented. The randomized antiplatelet effect was assessed in predefined three GRACE risk-groups; low-risk (GRACE <109), moderate-risk (GRACE 109-140), and high-risk (GRACE >140). RESULTS: The GRACE risk score was available in 6,594 out of 7,487 ACS patients among whom 1,743, 2,823, and 2,028 patients were classified as low-risk, moderate-risk, and high-risk, respectively. At 1 year, all-cause mortality occurred in 120 patients (1.8%). The discrimination ability of the GRACE model was moderate (C-statistic = 0.742), whereas 1-year mortality risk was overestimated (mean predicted mortality rate: 3.9%; the Hosmer-Lemeshow chi-square: 21.47; p = 0.006). There were no significant interactions between the GRACE risk strata and effects of the ticagrelor monotherapy on ischemic or bleeding outcomes at 1 year compared to the reference strategy. CONCLUSION: The GRACE risk score 2.0 is valuable in discriminating high risk ACS patients, however, the recalibration of the score is recommended for better risk stratification. There is no significant differences in efficacy and safety of ticagrelor monotherapy across the three GRACE risk strata.


Assuntos
Síndrome Coronariana Aguda , Intervenção Coronária Percutânea , Síndrome Coronariana Aguda/diagnóstico , Síndrome Coronariana Aguda/terapia , Humanos , Intervenção Coronária Percutânea/efeitos adversos , Inibidores da Agregação Plaquetária/efeitos adversos , Sistema de Registros , Medição de Risco , Fatores de Risco , Resultado do Tratamento
15.
Curr Cardiol Rev ; 2021 Apr 07.
Artigo em Inglês | MEDLINE | ID: mdl-33829975

RESUMO

BACKGROUND: Radiofrequency catheter ablation is a well-established treatment for several cardiac arrhythmias. Arrhythmias originating from the left side of the heart including ventricular and supraventricular tachycardia and ectopy can be successfully ablated through either transseptal or retrograde aortic approach. Although these techniques have a generally low rate of complications, aortic valve injury is a potential complication of ablation at the left cardiac side that warrants more investigation. OBJECTIVE: The purpose of this review is to evaluate the incidence of iatrogenic aortic valve regurgitation and explore the potential mechanisms and risk factors that might contribute to aortic valve injury during radiofrequency ablation. Additionally, the course and progression of aortic regurgitation in the reported cases will be described. METHODS AND RESULTS: Authors searched PubMed for articles using the keywords "ablation" AND "aortic insufficiency" OR "aortic valve injury" OR "aortic regurgitation". Case reports and series, as well as retrospective and prospective studies were included and relevant review articles and editorial comments were used as a supplementary source of data. A total of 19 references were used and a detailed description of patient characteristics, procedural techniques, and incidence, predictors, and fate of aortic regurgitation was reported by 11 clinical studies. CONCLUSION: There is a small risk of significant iatrogenic aortic regurgitation after radiofrequency ablation of left-sided cardiac arrhythmias especially techniques performed via a retrograde aortic approach. Although the risk is not confined to procedures applying direct energy to the aortic cusp region, a more aggressive ablation applied in the vicinity of the valvular complex seems to be associated with a higher risk. Routine post-procedural surveillance should be adopted to detect de novo aortic valve injury following radiofrequency ablation techniques.

16.
Heart Fail Rev ; 2021 Apr 11.
Artigo em Inglês | MEDLINE | ID: mdl-33839989

RESUMO

We sought to synthesize the available evidence regarding safety and efficacy of intermittent levosimendan (LEVO) infusions in ambulatory patients with end-stage heart failure (HF). Safety and efficacy of ambulatory intermittent LEVO infusion in patients with end-stage HF are yet not established. We systematically searched MEDLINE, EMBASE, SCOPUS, Web of Science, and Cochrane databases, from inception to January 30, 2021 for studies reporting outcome of adult ambulatory patients with end-stage HF treated with intermittent LEVO infusion. Fifteen studies (8 randomized and 7 observational) comprised 984 patients (LEVO [N = 727] and controls [N = 257]) met the inclusion criteria. LEVO was associated with improved New York Heart Association (NYHA) functional class (weighted mean difference [WMD] -1.04, 95%CI: -1.70 to -0.38, p < 0.001, 5 studies, I2 = 93%), improved left ventricular (LV) ejection fraction (WMD 4.0%, 95%CI: 2.8% to 5.3%, p < 0.001, 6 studies, I2 = 9%), and reduced BNP levels (WMD -549 pg/mL, 95%CI -866 to -233, p < 0001, 3 studies, I2 = 66%). All-cause death was not different (RR 0.65, 95%CI: 0.38 to 1.093, p = 0.10, 6 studies, I2 = 0), but cardiovascular death was lower on LEVO (RR 0.34, 95%CI: 0.13 to 0.87, p = 0.02, 3 studies, I2 = 0) compared to controls. Furthermore, health-related quality of life (HRQoL) was improved alongside with reduced LV size following LEVO infusions. Major adverse events were not different between LEVO and placebo. In conclusion, intermittent LEVO infusions in ambulatory patients with end-stage HF is associated with less frequent cardiovascular death alongside with improved NYHA class, quality of life, BNP levels, and LV function. However, the current evidence is limited by heterogeneous and relatively small studies.

17.
Glob Heart ; 16(1): 20, 2021 03 19.
Artigo em Inglês | MEDLINE | ID: mdl-33833944

RESUMO

Objectives: The aim of the present analysis is to compare the quantitative angiographic aortic regurgitation (AR) after transcatheter aortic valve implantation (TAVI) among three balloon-expandable valves. Background: Quantitative videodensitometric aortography is an objective, accurate, and reproducible tool for adjudication of AR following TAVI. Methods: This is a retrospective corelab analysis, independent from industry, of aortograms from patients treated with TAVI using the balloon-expandable Myval transcatheter heart valve (THV) (Meril Life Sciences Pvt. Ltd., India), Sapien 3, and XT THVs (Edwards Lifesciences, Irvine, CA, USA). The study comprised of 108 analyzable aortograms from consecutive patients in a multicenter European registry who underwent Myval THV implantation. The results of quantitative assessment of AR in the Sapien 3 THV (n = 397) and Sapien XT THV (n = 239) were retrieved from a published pooled database. Results: The Myval THV had the lowest proportion of patients with moderate or severe angiographic quantitative AR (2.8%) compared to the Sapien 3 THV (8.3%; p = 0.049) and Sapien XT THV (10.9%; p = 0.012). Furthermore, the Myval THV had the lowest mean angiographic quantitative AR (6.3 ± 6.3%), followed by Sapien 3 THV (7.6 ± 7.1%) and Sapien XT THV (8.8 ± 7.5%), and it was significantly lower than that of the Sapien XT THV (p = 0.006), but not significantly different from Sapien 3 THV (p = 0.246). Conclusion: The Myval THV, in comparison with other BEV's analyzed in our database, showed a lower occurrence of moderate or severe AR after TAVI. These results should be confirmed in prospective cohorts of randomized patients with head-to-head THV comparisons.


Assuntos
Insuficiência da Valva Aórtica , Estenose da Valva Aórtica , Próteses Valvulares Cardíacas , Substituição da Valva Aórtica Transcateter , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/cirurgia , Insuficiência da Valva Aórtica/diagnóstico por imagem , Insuficiência da Valva Aórtica/epidemiologia , Insuficiência da Valva Aórtica/etiologia , Estenose da Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/cirurgia , Humanos , Estudos Prospectivos , Desenho de Prótese , Estudos Retrospectivos , Substituição da Valva Aórtica Transcateter/efeitos adversos , Resultado do Tratamento
18.
J Cardiothorac Vasc Anesth ; 35(8): 2483-2495, 2021 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-33583718

RESUMO

OBJECTIVES: Veno-arterial extracorporeal membrane oxygenation (VA-ECMO) provides a temporary support system for patients with cardiogenic shock refractory to conventional medical therapies. It has been reported that levosimendan may facilitate VA-ECMO weaning and improve survival. The primary objective of this review was to examine the effect of levosimendan use on VA-ECMO weaning and mortality in critically ill patients on VA-ECMO. DESIGN: MEDLINE, EMBASE, and CENTRAL were searched. A pair of reviewers identified eligible clinical trials. Two reviewers extracted data and independently assessed the risk of bias. A random-effect model was used to combine data. The primary outcome was the success of weaning from VA-ECMO. MEASUREMENTS AND MAIN RESULTS: Seven studies of observational design, including a total of 630 patients, were selected in the final analysis. The sample size ranged from ten-to-240 patients, with a mean age between 53 and 65 years, and more than half of them underwent cardiac surgeries. The VA-ECMO durations varied between four and 11.6 days. Overall, levosimendan use was significantly associated with successful weaning compared with control (odds ratio [OR] 2.89, 95% CI, 1.53-5.46; poverall effect = 0.001); I2 = 49%). For survival, six studies (n = 617) were included in the meta-analysis involving 326 patients in the levosimendan group and 291 in the comparator group. Pooled results showed a significantly higher survival rate in the levosimendan group (OR 0.46, 95% CI, 0.30-0.71; poverall effect = 0.0004; I2 = 20%). CONCLUSIONS: Levosimendan therapy was significantly associated with successful weaning and survival benefit in patients with cardiogenic or postcardiotomy shock needing VA-ECMO support for severe cardiocirculatory compromise. To date, there is limited literature and absence of evidence from randomized trials addressing the use of levosimendan in VA-ECMO weaning. This study may be considered a hypothesis-generating research for randomized controlled trials to confirm its findings.


Assuntos
Procedimentos Cirúrgicos Cardíacos , Oxigenação por Membrana Extracorpórea , Choque , Idoso , Humanos , Pessoa de Meia-Idade , Ensaios Clínicos Controlados Aleatórios como Assunto , Choque Cardiogênico/tratamento farmacológico , Simendana
19.
JACC Cardiovasc Interv ; 14(5): 531-538, 2021 03 08.
Artigo em Inglês | MEDLINE | ID: mdl-33582086

RESUMO

OBJECTIVES: The aim of this study was to investigate the online assessment feasibility of aortography using videodensitometry in the catheterization laboratory during transcatheter aortic valve replacement (TAVR). BACKGROUND: Quantitative assessment of regurgitation after TAVR through aortography using videodensitometry is simple, reproducible, and validated in vitro, in vivo, in clinical trials, and in "real-world" patients. However, thus far the assessment has been done offline. METHODS: This was a single center, prospective, proof-of-principle, feasibility study. One hundred consecutive patients with aortic stenosis and indications to undergo TAVR were enrolled. All final aortograms were analyzed immediately after acquisition in the catheterization laboratory and were also sent to an independent core laboratory for blinded offline assessment. The primary endpoint of the study was the feasibility of the online assessment of regurgitation (percentage of analyzable cases). The secondary endpoint was the reproducibility of results between the online assessment and the offline analysis by the core laboratory. RESULTS: Patients' mean age was 81 ± 7 years, and 56% were men. The implanted valves were either SAPIEN 3 (97%) or SAPIEN 3 Ultra (3%). The primary endpoint of online feasibility of analysis was 92% (95% confidence interval [CI]: 86% to 97%) which was the same feasibility encountered by the core laboratory (92%; 95% CI: 86% to 97%). Reproducibility assessment showed a high correlation between online and core laboratory evaluations (R2 = 0.87, p < 0.001), with an intraclass correlation coefficient of 0.962 (95% CI: 0.942 to 0.975; p < 0.001). CONCLUSIONS: This study showed high feasibility of online quantitative assessment of regurgitation and high agreement between the online examiner and core laboratory. These results may pave the way for the application of videodensitometry in the catheterization laboratory after TAVR. (Online Videodensitometric Assessment of Aortic Regurgitation in the Cath-Lab [OVAL]; NCT04047082).


Assuntos
Insuficiência da Valva Aórtica , Estenose da Valva Aórtica , Próteses Valvulares Cardíacas , Substituição da Valva Aórtica Transcateter , Idoso , Idoso de 80 Anos ou mais , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/cirurgia , Insuficiência da Valva Aórtica/diagnóstico por imagem , Insuficiência da Valva Aórtica/etiologia , Insuficiência da Valva Aórtica/cirurgia , Estenose da Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/cirurgia , Aortografia , Estudos de Viabilidade , Humanos , Masculino , Estudos Prospectivos , Desenho de Prótese , Reprodutibilidade dos Testes , Fatores de Risco , Substituição da Valva Aórtica Transcateter/efeitos adversos , Resultado do Tratamento
20.
J Clin Med ; 10(3)2021 Jan 20.
Artigo em Inglês | MEDLINE | ID: mdl-33498412

RESUMO

Post-cardiotomy extracorporeal life support (PC-ECLS) has seen a substantial increase in use over the past 10 years. PC-ECLS can be a life-saving procedure and is mostly applied in the presence of unexpected, severe cardio-respiratory complication. Despite PC-ECLS being critical in allowing for organ recovery, it is unfortunately closely connected with an unpredictable outcomes, high morbidity, and, even in the case of cardiac function improvement, potential sustained disabilities that have a life-changing impact for the patient and his or her family. Since the decision to start PC-ECLS is made in an acute setting, there is often only limited or no time for self-determined choices. Due to the major impact of the intervention, it would be highly desirable to obtain informed consent before starting PC-ECLS, since the autonomy of the patient and shared-decision making are two of the most important ethical values in modern medicine. Recent developments regarding awareness of the impacts of a prolonged intensive care stay make this a particularly relevant topic. Therefore, it would be desirable to develop a structural strategy that takes into account the likelihood of such an intervention and the wishes and preferences of the patient, and thus the related autonomy of the patient. This article proposes key points for such a strategy in the form of a PC-ECLS informed consent, a do-(not-)mechanical-circulatory-support order (D(N)MCS), and specific guidelines to determine the extent of the shared decision making. The concept presented in this article could be a starting point for improved and ethical PC-ECLS treatment and application.

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