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SUMMARY BACKGROUND: There is no strong evidence on the link between inflammatory profile and pattern of drug treatment response in depressive patients that could result in Coronary Artery Disease occurrence. OBJECTIVE: This study aimed to compare the subclinical atherosclerosis markers, inflammatory profile, and BDNF production in Resistant Depression (RD) or Bipolar Affective Disorder (BAD) patients under conventional treatment. METHODS: The population evaluated was comprised of 34 RD, 43 BAD, and 41 controls. Subclinical atherosclerosis markers were evaluated using ultrasonography, tomography, and exercise stress test. Plasma concentrations of TNFα, IL-1β, IL-6, and BDNF were measured using Luminex100™. The usCRP concentration was measured using turbidimetric immunoassay. IL1B, IL6, and TNFA expression were determined using TaqMan®. For the statistical analysis, the significance level was established at p

Q-wave myocardial infarction (QWMI) comprises 2 entities. First, a clinically evident MI, which can occur spontaneously or be related to a coronary procedure. Second, silent MI which is incidentally detected on serial electrocardiographic (ECG) assessment. The prevalence of silent MI after percutaneous coronary intervention (PCI) in the drug-eluting stent era has not been fully investigated. The GLOBAL LEADERS is an all-comers multicenter trial which randomized 15,991 patients who underwent PCI to 2 antiplatelet treatment strategies. The primary end point was a composite of all-cause death or nonfatal new QWMI at 2-years follow-up. ECGs were collected at discharge, 3-month and 2-year visits, and analyzed by an independent ECG core laboratory following the Minnesota code. All new QWMI were further reviewed by a blinded independent cardiologist to identify a potential clinical correlate by reviewing clinical information. Of 15,968 participants, ECG information was complete in 14,829 (92.9%) at 2 years. A new QWMI was confirmed in 186 (1.16%) patients. Transient new Q-waves were observed in 28.5% (53 of 186) of them during the follow-up. The majority of new QWMI (78%, 146 of 186) were classified as silent MI due to the absence of a clinical correlate. Silent MI accounted for 22.1% (146 of 660) of all MI events. The prevalence of silent MI did not differ significantly between treatment strategies (experimental vs reference: 0.88% vs 0.98%, p = 0.5027). In conclusion, we document the prevalence of silent MI in an all-comers population undergoing PCI in this large-scale randomized trial. info:eu-repo/semantics/publishedVersion

Background Familial hypercholesterolemia (FH) is a genetic disease that affects millions of people worldwide. Objectives The study protocol FHBGEP was design to investigate the main genomic, epigenomic, and pharmacogenomic factors associated with FH and polygenic hypercholesterolemia (PH). Methods FH patients will be enrolled at six research centers in Brazil. An exon-targeted gene strategy will be used to sequence a panel of 84 genes related to FH, PH, pharmacogenomics and coronary artery disease. Variants in coding and regulatory regions will be identified using a proposed variant discovery pipeline and classified according to the American College Medical Genetics guidelines. Functional effects of variants in FH-related genes will be investigated by in vitro studies using lymphocytes and cell lines (HepG2, HUVEC and HEK293FT), CRISPR/Cas9 mutagenesis, luciferase reporter assay and other technologies. Functional studies in silico, such as molecular docking, molecular dynamics, and conformational analysis, will be used to explore the impact of novel variants on protein structure and function. DNA methylation profile and differential expression of circulating non-coding RNAs (miRNAs and lncRNAs) will be analyzed in FH patients and normolipidemic subjects (control group). The influence of genomic and epigenomic factors on metabolic and inflammatory status will be analyzed in FH patients. Pharmacogenomic studies will be conducted to investigate the influence of genomic and epigenomic factors on response to statins in FH patients. Summary The FHBGEP protocol has the potential to elucidate the genetic basis and molecular mechanisms involved in the pathophysiology of FH and PH, particularly in the Brazilian population. This pioneering approach includes genomic, epigenomic and functional studies, which results will contribute to the improvement of the diagnosis, prognosis and personalized therapy of FH patients.

Hypertrophic cardiomyopathy (HCM) is characterized by unexplained left ventricular hypertrophy (LVH) and is one of the major causes of sudden cardiac death (SCD). An exon-targeted gene sequencing strategy was used to investigate the association of functional variants in sarcomeric genes (MYBPC3, MYH7 and TNNT2) with severe LVH and other SCD-related risk factors in Brazilian HCM patients. Clinical data of 55 HCM patients attending a Cardiology Hospital (Sao Paulo city, Brazil) were recorded. Severe LVH, aborted SCD, family history of SCD, syncope, non-sustained ventricular tachycardia and abnormal blood pressure in response to exercise were evaluated as SCD risk factors. Blood samples were obtained for genomic DNA extraction and the exons and untranslated regions of the MYH7, MYBPC3 and TNNT2 were sequenced using Nextera® and MiSEq® reagents. Variants were identified and annotated using in silico tools, and further classified as pathogenic or benign according to the American College of Medical Genetics and Genomics guidelines. Variants with functional effects were identified in MYBPC3 (n = 9), MYH7 (n = 6) and TNNT2 (n = 4). The benign variants MYBPC3 p.Val158Met and TNNT2 p.Lys263Arg were associated with severe LVH (p 0.05), and the MYH7 p.Val320Met (pathogenic) was associated with family history of SCD (p = 0.037). Increased risk for severe LVH was found in carriers of MYBPC3 Met158 (c.472 A allele, OR = 13.5, 95% CI = 1.80-101.12, p = 0.011) or combined variants (MYBPC3, MYH7 and TNNT2: OR = 12.39, 95% CI = 2.14-60.39, p = 0.004). Carriers of TNNT2 p.Lys263Arg and combined variants had higher values of septum thickness than non-carriers (p 0.05). Molecular modeling analysis showed that MYBPC3 158Met reduces the interaction of cardiac myosin-binding protein C (cMyBP-C) RASK domain (amino acids Arg215-Ala216-Ser217-Lys218) with tropomyosin. In conclusion, the variants MYBPC3 p.Val158Met, TNNT2 p.Lys263Arg and MYH7 p.Val320Met individually or combined contribute to the risk of sudden cardiac death and other outcomes of hypertrophic cardiomyopathy.

Introduction Few data exist regarding the late clinical impact of the Selvester score prediction of myocardial fibrosis after transcatheter aortic valve replacement (TAVR). This study evaluated the predictive power of the Selvester score on survival in patients with aortic stenosis (AS) undergoing TAVR. Methods and results Patients with severe AS who had preoperative electrocardiograms were included. Clinical follow-up was obtained retrospectively. The primary endpoint was all-cause mortality. Secondary endpoints were cardiovascular death and major adverse cardiac events (MACE). Two hundred twenty-eight patients were included (mean age, 81.5±7.4 years; women, 58.3%). Deceased patients had a higher mean score (4.6±3.2 vs. 1.4±1.3; p Conclusions Elevated Selvester scores increase the risk of poor outcomes in patients with AS undergoing TAVR. The involvement of the anterior or lateral wall presents worse prognosis. Kaplain Meier and ROC Curve Funding Acknowledgement Type of funding source: None

Introduction Transcatheter aortic valve replacement (TAVR) is increasingly utilized in treatment of aortic stenosis (AS). AS is commonly associated to pulmonary hypertension (PH) and tricuspid regurgitation (TR). We aimed to evaluate the long-term post-TAVR course of PH and TR. Methods Patients undergoing TAVR were screened for 24-month echocardiographic data on PH and TR. All echocardiograms were performed by a single team. Patients were divided in groups according to TR and PH (pulmonary systolic pressure ≥ or Results 156 and 151 patients were selected for PH and TR follow-up, respectively. Mean follow-up was 42.23±17.53 months and 42.60±17.67 months for PH and TR groups. Maximum follow-up was 96 months. PH was reduced post-TAVR (32.7% pre-TAVR vs. 20.5% post-TAVR, p Conclusions TAVR was able to reduce the severity of PH, but not TR, in this cohort. Additionally, long-term survival was affected by PH, diastolic dysfunction and LA sizing. Kaplan-Meier survival curve Funding Acknowledgement Type of funding source: None

INTRODUCTION Few data exist regarding the late clinical impact of the Selvester score prediction of myocardial fibrosis after transcatheter aortic valve replacement (TAVR). This study evaluated the predictive power of the Selvester score on survival in patients with aortic stenosis (AS) undergoing TAVR. METHODS AND RESULTS Patients with severe AS who had preoperative electrocardiograms were included. Clinical follow-up was obtained retrospectively. The primary endpoint was all-cause mortality. Secondary endpoints were cardiovascular death and major adverse cardiac events (MACEs). Two-hundred twenty-eight patients were included (mean age, 81.5 ± 7.4 years; women, 58.3%). Deceased patients had a higher mean score (4.6 ± 3.2 vs. 1.4 ± 1.3; p

The aim of this study was to assess very long term outcomes after successful percutaneous balloon mitral valvuloplasty (PBMV).PBMV remains the preferred treatment for patients with severe symptomatic rheumatic mitral stenosis and suitable anatomy.All consecutive patients who underwent successful PBMV between 1987 and 2010 were included. The primary endpoint was the composite of all-cause mortality, need for mitral surgery, or repeat PBMV up to 23 years.Among all 1,582 consecutive patients undergoing PBMV, acute success was achieved in 90.9% (n = 1,438). Independent predictors of acute success included left atrial size (odds ratio: 0.96; 95% confidence interval [CI]: 0.93 to 0.99; p = 0.045), Wilkins score ≤8 (odds ratio: 1.66; 95% CI: 0.48 to 0.93; p = 0.02) and age (odds ratio: 0.97; 95% CI: 0.96 to 0.99; p = 0.006). Very long term follow-up (median 8.3 years, mean 15.6 years) was obtained in 79.1% of successful cases. The incidence of the primary endpoint was 19.1% (95% CI: 17.0% to 21.1%). The rates of overall mortality, need for mitral valve surgery, or repeat PBMV were 0.6% (95% CI: 0.3% to 1.2%), 8.3% (95% CI: 7.0% to 9.9%), and 10.0% (95% CI: 8.5% to 11.7%), respectively. On multivariate analysis, New York Heart Association functional class III or IV (hazard ratio: 1.62; 95% CI: 1.26 to 2.09; p 0.001), higher age (hazard ratio: 0.97; 95% CI: 0.96 to 0.98; p = 0.028), and mitral valve area ≤1.75 cmIn very long term follow-up, more than 75% of patients exhibited sustained results. Prediction of late favorable results is multifactorial and strongly determined by age, previous symptoms and post-procedural mitral valve area.

The objective of this study was to evaluate the correlation between venous pressure gradients (VPGs) and intravascular ultrasound (IVUS) for the diagnosis of caval-iliac venous obstructions in patients with advanced chronic venous insufficiency.Fifty patients with advanced chronic venous insufficiency symptoms (Clinical, Etiology, Anatomy, and Pathophysiology class 3 to 6) were prospectively submitted to multiplanar venography (MV) with intravenous pressure measurements and IVUS. The patients' lower limbs were divided accordingly: group I, limbs with 50% obstruction on IVUS (n = 49); and group II, limbs with ≥50% obstruction on IVUS (n = 51). Receiver operating characteristic curves compared the diagnostic performance of the VPGs. Sensitivity, specificity, positive predictive value, negative predictive value, and accuracy assessed the performance of VPGs in categories to determine the presence of significant obstruction. Logistic regression assessed the capacity of the VPGs to identify significant obstruction.The most frequent point of venous compression according to IVUS was the proximal left common iliac vein (70%; P .05). Group II showed a greater prevalence of transpelvic (group I, 8.2%; group II, 74.5%; P .001) and paravertebral collaterals (group I, 4.1%; group II, 45.1%; P .001) on MV. The femoral vein pressures at rest and after reactive hyperemia as well as the femorocaval gradient after reactive hyperemia (FCG-rh) and the femoral gradient after reactive hyperemia were significantly higher in group II (P = .001, P .001, P = .002, and P = .006). The FCG-rh and the femoral gradient after reactive hyperemia presented the best diagnostic performance among the VPGs (P = .004 and P = .007) in the receiver operating characteristic curve analysis, although no significant differences between them were found. All the gradients presented low values of sensitivity (40%), negative predictive value (60%), and accuracy (30%). Logistic regression showed that FCG-rh was significantly independent of MV (OR, 8.1; P = .011) in identifying significant obstructions.There is correlation between the VPGs and significant obstructions with IVUS. However, this correlation does not translate to a good diagnostic performance of these VPGs. Only the FCG-rh added significant information to MV in identifying significant caval-iliac vein obstructions.

Background Previous evidence suggests that acute treatment with statins reduce atherosclerotic complications, including periprocedural myocardial infarction, but currently, there are no large, adequately powered studies to define the effects of early, high-dose statins in patients with acute coronary syndrome (ACS) and planned invasive management. Objectives The main goal of Statins Evaluation in Coronary procedUres and REvascularization (SECURE-PCI) Trial is to determine whether the early use of a loading dose of 80 mg of atorvastatin before an intended percutaneous coronary intervention followed by an additional dose of 80 mg 24 hours after the procedure will be able to reduce the rates of major cardiovascular events at 30 days in patients with an ACS. Design The SECURE-PCI study is a pragmatic, multicenter, double-blind, placebo-controlled randomized trial planned to enroll around 4,200 patients in 58 different sites in Brazil. The primary outcome is the rate of major cardiovascular events at 30 days defined as a composite of all-cause mortality, nonfatal acute myocardial infarction, nonfatal stroke, and coronary revascularization. Summary The SECURE PCI is a large randomized trial testing a strategy of early, high-dose statin in patients with ACS and will provide important information about the acute treatment of this patient population.

INTRODUCTION Bioresorbable coronary scaffolds (BRS) have been developed to increase the late safety of coronary angioplasty by providing transitory coronary support and then being fully incorporated to the vessel wall. In the present trial, we sought to evaluate the performance and changes over time in the DESolve™ novolimus-eluting BRS using serial intravascular ultrasound (IVUS) in patients submitted to percutaneous coronary interventions. METHODS Single-center, prospective, non-randomized study involving 17 consecutive patients submitted to implantation of the DESolve™ scaffold and serial evaluated with IVUS at different time points (post procedure, 6 and 18 months). Primary endpoint included the variation in lumen, scaffold, and vessel diameter and area along the months. RESULTS Angiographic success was achieved in all cases. Scaffold area and volume on IVUS were significantly greater at 6 months than at baseline (6.41 ± 1.35 mm2 vs. 7.35 ± 1.53 mm2 , P

Background: We evaluated the association of pulse pressure (PP) and different antiplatelet regimes with clinical and safety outcomes in an all-comers percutaneous coronary intervention (PCI) population. Methods: In this analysis of GLOBAL LEADERS (n = 15,936) we compared the experimental therapy of 23 months of ticagrelor after 1 month of dual-antiplatelet therapy (DAPT) versus standard DAPT for 12 months followed by aspirin monotherapy in subjects who underwent PCI and were divided into 2 groups according to the median PP (60 mm Hg). The primary end point (all-cause death or new Q-wave myocardial infarction) and the composite end points: patient-oriented composite end points (POCE), Bleeding Academic Research Consortium (BARC) 3 or 5, and net adverse clinical events (NACE) were evaluated. Results: At 2 years, subjects in the high-PP group (n = 7971) had similar rates of the primary end point (4.3% vs 3.9%; P = 0.058), POCE (14.9% vs 12.7%; P = 0.051), and BARC 3 or 5 (2.5% vs 1.7%; P = 0.355) and higher rates of NACE (16.4% vs 13.7%; P = 0.037) compared with the low-PP group (n = 7965). Among patients with PP < 60 mm Hg, the primary end point (3.4% vs 4.4%, adjusted hazard ratio [aHR] 0.77, 95% confidence interval [CI] 0.61-0.96), POCE (11.8% vs 13.5%, aHR 0.86, 95% CI 0.76-0.98), NACE (12.8% vs 14.7%, aHR 0.85, 95% CI 0.76-0.96), and BARC 3 or 5 (1.4% vs 2.1%, aHR 0.69, 95% CI 0.49-0.97) were lower with ticagrelor monotherapy compared with DAPT. The only significant interaction was for BARC 3 or 5 (P = 0.008). Conclusions: After contemporary PCI, subjects with high PP levels experienced high rates of NACE at 2 years. In those with low PP, ticagrelor monotherapy led to a lower risk of bleeding events compared with standard DAPT.

Objective We sought to compare the new transcatheter aortic valve replacement (TAVR) device ACURATE neo (ACT) with the already established CoreValve (MCV) and SAPIEN XT (SXT) for the treatment of severe aortic stenosis (AS). Background Very few data on TAVR devices are available beyond MCV and SAPIEN and there is no previous study comparing ACT with MCV and SXT. Methods We prospectively evaluated consecutive patients who underwent transfemoral TAVR for the treatment of severe AS. Clinical outcomes were reported following Valve Academic Research Consortium 2 (VARC-2) criteria. Results A total of 162 patients (ACT n = 49, MCV n = 56, SXT n = 57), were included. MCV group had higher valve embolization/migration rates (ACT none; MCV 9%; SXT 2%; P = 0.034) causing lower device success rates (ACT 98%; MCV 86%; SXT 95%; P = 0.043). At 30 days, there was no significant difference in all-cause mortality (P = 0.22), cardiovascular mortality (P = 0.20), periprocedural myocardial infarction (P = 0.40), stroke (P = 0.64), major vascular complications (P = 0.48), life-threatening bleeding (P = 0.29), acute kidney injury stage 2/3 (P = 0.69), or VARC-2 composite early safety endpoints (P = 0.21). MCV group had higher rates of new permanent pacemaker implantation (ACT 6%; MCV 25%; SXT 11%; P = 0.013). Follow-up echocardiography showed no significant difference in aortic valve mean pressure gradient (P = 0.73) or moderate/severe aortic regurgitation (P = 0.19) between groups. Conclusions In a “real world” registry, ACT compared favorably against the well-studied SXT and MCV devices in both safety and efficacy. MCV implantation was associated with lower device success rates and higher rates of new permanent pacemaker implantation. © 2016 Wiley Periodicals, Inc.

Objectives To compare the radial versus femoral approach using Angio-Seal for the incidence of access site complications among non-ST-segment elevation acute coronary syndrome patients undergoing invasive strategy. Background Arterial access is a major site of complications after invasive coronary procedures. Vascular closure devices provide more comfort to patients decreasing time to hemostasis and need for bed rest. However, the inconsistency of data proving their safety limits their routine adoption as a strategy to prevent vascular complications. Methods Single-center non-inferiority trial where 240 patients were randomized to radial or femoral access using Angio-Seal. The primary objective was the occurrence of complications at the arterial puncture site until 30 days after the procedure. Results There were no baseline clinical differences between groups, except for a greater prevalence of female patients in the radial group (33.3 vs. 20.0%, P = 0.020). Hemostasis was achieved in the entire radial group with the use of TR Band and in 95% of the procedures in the femoral group with Angio-Seal (P = 0.029). Except for a higher incidence of asymptomatic arterial occlusion in the radial group, there were no differences among the other analyzed outcomes. According to the noninferiority test, the use of Angio-Seal was noninferior to the radial approach, considering the margin of 15% (12.5 vs. 13.3%, difference −0.83%, 95% CI −9.31 − 7.65, P for noninferiority

Objectives The objectives of the present study were to analyze the variation of renal function after transcatheter aortic valve replacement (TAVR) focused on acute kidney injury (AKI) and its impact on short- and mid-term mortality. Background Changes on renal function after TAVR and their impact on clinical outcomes are incompletely understood until now. Methods At two tertiary centers 221 consecutive patients were submitted to TAVR. Kidney injury was defined according to VARC-2 criteria. Patients were classified according to the presence (group 1) or absence (group 2) of AKI. Creatinine values were collected daily until seventh day after procedure, 1 month, 6 months, and then 1 year after TAVR. Results At baseline, groups were similar, except for EuroSCORE II (8.66% vs. 7.34%, P = 0.02) and glomerular filtration rate (GFR) (39.59 vs. 48.49 mL/min.1.73 m2, P = 0.002). Overall 30 day-mortality and 1-year mortality were 6.3% and 14.0%, respectively. Both 30-day mortality (23.1% vs. 1.2%, P

RESUMO Introducao Apesar do advento dos stents farmacologicos (SF), diabeticos ainda experimentam risco aumentado de eventos cerebrovasculares e cardiovasculares maiores (ECCAM) apos intervencao coronaria percutânea (ICP). Nosso objetivo foi avaliar a incidencia de ECCAM (obito, acidente vascular cerebral, infarto agudo do miocardio nao fatal ou revascularizacao da lesao alvo) no seguimento de pelo menos 1 ano, alem da capacidade de os escores SYNTAX e SYNTAX residual predizerem eventos. Metodos Estudo unicentrico, retrospectivo, de diabeticos com doenca coronariana multiarterial, incluindo lesoes de tronco de coronaria esquerda (TCE), tratados com SF entre 2012 a 2014. Resultados Foram incluidos 158 pacientes, com media de idades de 65,1 ± 9,1 anos. Em 44,2% dos casos, havia lesao proximal da arteria descendente anterior e 9% apresentavam lesao de TCE. A maioria dos procedimentos foi realizada com SF de segunda geracao (91,1%). A media de seguimento foi de 1.054 ± 725 dias, e o ECCAM ocorreu em 17,4% dos pacientes. Entre aqueles com escore SYNTAX baixo ( Conclusoes O presente estudo aponta para a factibilidade e a seguranca da realizacao de ICP em diabeticos multiarteriais, especialmente entre aqueles com baixa complexidade angiografica. A revascularizacao incompleta foi preditora da maior ocorrencia de ECCAM no seguimento de medio/longo prazo.

Raise of CKMB after PCI correlates with the degree of myocardial injury and might impact clinical outcomes. Sevoflurane is an inhalator halogen anesthetic able to promote myocardial protection through a preconditioning mechanism which might prevent raise of cardiac markers after PCI. Randomised

Left ventricular diastolic function is an important prognostic marker in acute coronary syndrome. However, classification of the dysfunction grade using isolated echocardiographic parameters remains difficult. Therefore, it is necessary to combine multiple data in diagnostic algorithms. The purpose of this study was to evaluate the capacity of left atrial strain (LAS) components to classify left ventricular diastolic dysfunction (DD) grade. Cross-sectional study with 109 consecutive patients admitted to the emergency room with acute coronary syndrome. Patients were referred for echocardiographic evaluation within 72 h. Mean values of LAS, corresponding to three phases of atrial function (reservoir, conduit and contraction), were obtained by speckle-tracking echocardiography. Patients were divided according to the diastolic dysfunction grade for later association with the LAS. The three LAS components showed moderate correlation with most diastolic variables (left atrial volume index, E/e′ ratio and e′ wave). In addition, there was related reduction of the LAS, which was inversely proportional to the DD grade (p

Importance The effects of loading doses of statins on clinical outcomes in patients with acute coronary syndrome (ACS) and planned invasive management remain uncertain. Objective To determine if periprocedural loading doses of atorvastatin decrease 30-day major adverse cardiovascular events (MACE) in patients with ACS and planned invasive management. Design, Setting, and Participants Multicenter, double-blind, placebo-controlled, randomized clinical trial conducted at 53 sites in Brazil among 4191 patients with ACS evaluated with coronary angiography to proceed with a percutaneous coronary intervention (PCI) if anatomically feasible. Enrollment occurred between April 18, 2012, and October 6, 2017. Final follow-up for 30-day outcomes was on November 6, 2017. Interventions Patients were randomized to receive 2 loading doses of 80 mg of atorvastatin (n = 2087) or matching placebo (n = 2104) before and 24 hours after a planned PCI. All patients received 40 mg of atorvastatin for 30 days starting 24 hours after the second dose of study medication. Main Outcomes and Measures The primary outcome was MACE, defined as a composite of all-cause mortality, myocardial infarction, stroke, and unplanned coronary revascularization through 30 days. Results Among the 4191 patients (mean age, 61.8 [SD, 11.5] years; 1085 women [25.9%]) enrolled, 4163 (99.3%) completed 30-day follow-up. A total of 2710 (64.7%) underwent PCI, 333 (8%) underwent coronary artery bypass graft surgery, and 1144 (27.3%) had exclusively medical management. At 30 days, 130 patients in the atorvastatin group (6.2%) and 149 in the placebo group (7.1%) had a MACE (absolute difference, 0.85% [95% CI, −0.70% to 2.41%]; hazard ratio, 0.88; 95% CI, 0.69-1.11;P = .27). No cases of hepatic failure were reported; 3 cases of rhabdomyolysis were reported in the placebo group (0.1%) and 0 in the atorvastatin group. Conclusions and Relevance Among patients with ACS and planned invasive management with PCI, periprocedural loading doses of atorvastatin did not reduce the rate of MACE at 30 days. These findings do not support the routine use of loading doses of atorvastatin among unselected patients with ACS and intended invasive management. Trial Registration clinicaltrials.gov Identifier: NCT01448642

RESUMO Introducao O conhecimento dos fatores de risco relacionados as complicacoes do acesso vascular em pacientes submetidos a estrategia invasiva precoce permite adotar estrategias capazes de minimiza‐las. Metodos Realizamos subanalise do estudo ARISE, com o objetivo de identificar preditores de complicacoes vasculares em pacientes randomizados para as tecnicas radial ou femoral com emprego de dispositivo de oclusao vascular (DOV). Resultados Foram incluidos 240 pacientes, com media de idade de 63,0 ± 10,7 anos, sendo 30,8% diabeticos e, exceto pela maior prevalencia de mulheres no grupo radial, nao foram observadas diferencas clinicas entre os grupos. Intervencao coronaria percutânea foi realizada em 86,7% dos casos. A taxa de complicacoes vasculares aos 30 dias foi de 13,3% no grupo radial, a custa de hematomas > 5 cm (6,7%) e oclusao arterial assintomatica (5,8%), e de 12,5% no grupo femoral, a custa de hematomas > 5 cm, sem diferenca significativa. Foram identificados como fatores de risco para complicacoes do acesso vascular o indice de massa corporal (IMC), o acidente vascular encefalico previo, a maior duracao do procedimento e o insucesso do DOV. Pela analise estratificada, o sexo feminino e o escore CRUSADE de alto ou muito alto risco foram variaveis preditoras de complicacoes apenas para o grupo femoral. No modelo multivariado, os fatores que permaneceram significantes foram o IMC e o insucesso do DOV. Conclusoes As tecnicas radial e femoral, com o emprego de DOV, compartilharam variaveis preditoras de complicacoes. Fatores de risco, como sexo feminino e escore CRUSADE de alto risco, foram atenuados pela utilizacao da tecnica radial.

RESUMO Introducao O stent MGuard™, revestido por malha polimerica microscopica, tem a finalidade de reduzir a embolizacao distal de fragmentos durante a intervencao coronaria percutânea (ICP) em enxertos de veia safena (EVS). Avaliamos os desfechos clinicos precoces e tardios de pacientes submetidos a ICP de EVS com stents MGuard™ vs. stents farmacologicos (SF). Metodos Estudo observacional, retrospectivo, realizado em dois centros terciarios, envolvendo uma coorte de pacientes com lesoes em EVS, tratados de forma eletiva ou de emergencia com stents MGuard™ ou SF. Resultados Foram incluidos 271 pacientes, sendo 220 tratados com SF. O Grupo MGuard™ apresentou maior proporcao de mulheres (25,5% vs. 10,5%; p=0,01), com media de idades de 65,0 ± 13,9 anos vs. 69,0 ± 9,6 anos (p = 0,06). O Grupo SF utilizou com maior frequencia filtro de protecao distal (5,8% vs. 10,0%; p = 0,001). Sucesso angiografico foi obtido na maioria dos casos (96,2% vs. 98,0%; p = 0,22). O Grupo MGuard™ teve menores taxas de eventos cardiovasculares adversos maiores (ECAM) na fase hospitalar que o Grupo SF (1,9% vs. 13,6%; p = 0,01) devido exclusivamente a menor incidencia de infarto periprocedimento. Entretanto, a taxa de ECAM em 1 ano foi maior no grupo MGuard™ (14,3% vs. 4,4%; p = 0,01) a custa de maior taxa de revascularizacao da lesao alvo (7,1% vs. 1,3%; p = 0,048). Conclusoes A utilizacao de stent MGuard™ resultou em reducao de eventos na fase hospitalar, porem, no longo prazo, os SF foram superiores em reduzir desfechos maiores, sobretudo a necessidade de revascularizacao da lesao alvo.

Background The knowledge of risk factors related to vascular access complications in patients undergoing early invasive strategy allows the adoption of methods to minimize them. Methods We performed a subanalysis of the ARISE study, aiming to identify predictors of vascular complications in patients randomized to the radial or femoral techniques with the use of vascular closure device (VCD). Results A total of 240 patients with a mean age of 63.0 ± 10.7 years were included, with 30.8% of diabetics. Except for a higher prevalence of women in the radial group, there were no clinical differences between the groups. Percutaneous coronary intervention was performed in 86.7% of the cases. The rate of vascular complications after 30 days was 13.3% in the radial group, due to hematoma > 5 cm (6.7%) and asymptomatic artery occlusion (5.8%), and 12.5% in femoral group, due to hematoma > 5 cm, without significant difference. The following were identified as risk factors for vascular access complications: body mass index (BMI), previous stroke, longer duration of the procedure, and VCD failure. At the stratified analysis, female gender and high or very high-risk CRUSADE score were predictors of complications only for the femoral group. In the multivariate model, the factors that remained significant were BMI and VCD failure. Conclusions The radial and femoral techniques, with the use of VCD, shared variables that were predictors of complications. Risk factors, such as female gender and high-risk CRUSADE score, were attenuated by the use of the radial technique.

RESUMOIntroduçãoA revascularização miocárdica anatômica completa está associada a um melhor controle dos sintomas anginosos e a menores índices de eventos cardíacos maiores tardios. No entanto, em substancial número de pacientes tratados por meio de intervenção coronária percutânea (ICP), não logramos sua obtenção. Assim, nosso objetivo foi avaliar os fatores associados à revascularização miocárdica incompleta (RMI) em casos de ICP multiarterial.MétodosEstudo de coorte envolvendo 1.049 pacientes revascularizados de forma prospectiva e consecutiva por meio de ICP com tratamento de dois ou mais vasos, entre 2012 e 2014, divididos em dois grupos: RMI (n=324; 30,9%) e revascularização miocárdica completa (n=725; 69,1%).ResultadosA RMI foi significativamente associada a faixa etária maior (66,5 anos vs. 64,1 anos; p=0,003), hipertensão arterial (92,2% vs. 86,0%; p=0,006), insuficiência renal crônica (36.4% vs. 26.0%; p < 0,001), síndrome coronariana aguda (26,3% vs. 21,0%; p=0,05), revascularização cirúrgica prévia (16,1% vs. 7,1%; p=0,001), lesões em enxertos venosos (3,4% vs. 1,0%; p < 0,001) e oclusões crônicas (3,3% vs. 1,4%; p=0,005), bem como a menor acesso a stents farmacológicos (57,8% vs. 64,8%; p=0,002). Os resultados clínicos hospitalares não diferiram entre os grupos.ConclusõesA RMI ocorreu em cerca de um terço dos casos tratados, tendo sido observada associação significativa, com um perfil clínico de maior risco e com intervenções em lesões alvo comumente associadas com menor sucesso do procedimento. O grau de revascularização não gerou impacto nos resultados clínicos da fase hospitalar.ABSTRACTBackgroundComplete anatomical myocardial revascularization is associated with better angina control and lower rates of cardiac events. However, in a significant number of patients treated by percutaneous coronary intervention (PCI), complete revascularization is not achieved. Thus, the aim of this study was to evaluate factors associated with incomplete myocardial revascularization (IMR) in multivessel PCI patients.MethodsThis was a cohort study involving 1,049 prospectively and consecutively revascularized patients through PCI with treatment of two or more vessels, between 2012 and 2014, divided into two groups: IMR (n=324; 30.9%) and complete myocardial revascularization (n=725; 69.1%).ResultsIMR was significantly associated with older age (66.5 years vs. 64.1 years; p=0.003), arterial hypertension (92.2% vs. 86.0%; p=0.006), chronic renal failure (36.4% vs. 26.0%; p < 0.001), acute coronary syndrome (26.3% vs. 21.0%; p=0.05), previous surgical revascularization (16.1% vs. 7.1%; p=0.001), saphenous venous graft lesions (3.4% vs. 1.0%, p < 0.001), and chronic occlusions (3.3% vs. 1.4%, p=0.005), as well as lower access to drug‐eluting stents (57.8% vs. 64.8%; p=0.002). In‐hospital clinical outcomes did not differ between the groups.ConclusionsIMR occurred in approximately one‐third of treated cases, and a significant association was observed with a higher‐risk clinical profile and with target lesion interventions commonly associated with lower procedure success. The degree of revascularization had no impact on in‐hospital clinical outcomes.

Objectives To determine the impact of percutaneous coronary intervention (PCI) performed at the same time of the peak concentration of rosuvastatin to reduce periprocedural myocardial infarction (PMI). Background Prior studies suggest that a high dose of statin before PCI reduce periprocedural myocardial infarction. However, there is no information regarding the elective PCI performed at the time of the peak of statin concentration to reduce PMI. Methods From 2001 to 2013, at a single center in Brazil we enrolled 544 patients who underwent elective PCI and after exclusions for baseline biases in clinical and angiographic characteristics, yielding 528 patients, we prospectively randomly assigned them to either a high loading dose of Rosuvastatin before PCI (n = 264) or standard treatment (n = 264). After exclusions for biases in procedural characteristics a total of 487 patients underwent to end points analysis. The primary outcome was the incidence of MB fraction of creatine kinase (CK-MB) greater than three times the upper limit of normal. Results The primary end point occurred in 7.6% in the rosuvastatin and 4.8% in the control group (P = 0.200). There was a higher incidence in elevation of CK-MB than normal baseline in the rosuvastatin (67.1% vs 59.2%, P = 0.701). There was no difference in major adverse event (0% in the rosuvastatin group vs 0.8% in control).

ObjectivesThis study aimed to assess 6-month outcomes in patients with implantable cardioverter-defibrillators (ICDs) undergoing renal sympathetic denervation (RSD) for refractory ventricular arrhythmias (VAs).BackgroundICDs are generally indicated for patients at high risk of malignant VAs. Sympathetic hyperactivity plays a critical role in the development, maintenance, and aggravation of VAs.MethodsA total of 10 patients with refractory VA underwent RSD. Underlying conditions were Chagas disease (n = 6), nonischemic dilated cardiomyopathy (n = 2), and ischemic cardiomyopathy (n = 2). Information on the number of ventricular tachycardia (VT)/ventricular fibrillation (VF) episodes and device therapies (antitachycardia pacing/shocks) in the previous 6 months as well as 1 and 6 months post-treatment was obtained from ICD interrogation.ResultsThe median number of VT/VF episodes/antitachycardia pacing/shocks 6 months before RSD was 28.5 (range 1 to 106)/20.5 (range 0 to 52)/8 (range 0 to 88), respectively, and was reduced to 1 (range 0 to 17)/0 (range 0 to 7)/0 (range 0 to 3) at 1 month and 0 (range 0 to 9)/0 (range 0 to 7)/0 (range 0 to 3) at 6 months afterward, respectively. There were no major procedure-related complications. Two patients experienced sustained VT within the first week; in both cases, no further episodes occurred during follow-up. Two patients were nonresponders: 1 with persistent idioventricular rhythm and 1 with multiple renal arteries and incomplete ablation. Three patients died during follow-up. None of the deaths was attributed to VA.ConclusionsIn patients with ICDs and refractory VAs, RSD was associated with reduced arrhythmic burden with no procedure-related complications. Randomized controlled trials investigating RSD for treatment of refractory VAs in patients with increased sympathetic activity are needed.

ResumoIntroduçãoCardiodesfibriladores implantáveis (CDIs) são geralmente indicados para pacientes com arritmias malignas considerados de alto risco. A hiperatividade simpática desempenha um papel crítico no desenvolvimento, na manutenção e no agravamento de arritmias ventriculares. Novas opções de tratamento nessa população representam uma necessidade clínica. Nosso objetivo foi relatar os resultados de pacientes com CDIs e tempestade elétrica submetidos à denervação simpática renal para controle da arritmia.MétodosOito pacientes com CDIs internados por tempestade elétrica refratária ao tratamento médico otimizado foram submetidos à denervação simpática renal. Condições subjacentes foram: doença de Chagas (n = 6), cardiomiopatia dilatada não isquêmica (n = 1) e cardiomiopatia isquêmica (n = 1). As informações sobre o número de taquicardias ventriculares/fibrilações ventriculares e episódios de terapias antitaquicardia na última semana pré‐procedimento e nos 30 dias pós‐tratamento foram obtidas por meio de interrogação dos CDIs.ResultadosAs medianas dos episódios de taquicardias ventriculares/fibrilações ventriculares, sobre‐estimulação e choques na semana que antecedeu a denervação simpática renal foram de 29 (9 a 106), 23 (2 a 94) e 7,5 (1 a 88), sendo significativamente reduzidas para 0 (0 a 12), 0 (0 a 30) e 0 (0 a 1), respectivamente, 1 mês após o procedimento (p = 0,002; p = 0,01; p = 0,003). Nenhum paciente morreu durante o acompanhamento. Não ocorreram complicações maiores relacionadas ao procedimento.ConclusõesEm pacientes com CDIs e tempestade elétrica refratária ao tratamento médico otimizado, a denervação simpática renal reduziu significativamente a carga de arritmia e, consequentemente, as sobre‐estimulações e os choques. Ensaios clínicos randomizados, no contexto de denervação simpática renal para controle de arritmias cardíacas refratárias, são necessários para trazer maior robustez aos nossos achados.AbstractBackgroundImplantable cardioverter‐defibrillators (ICDs) are usually indicated for patients with malignant arrhythmias considered as high risk. Sympathetic hyperactivity plays a critical role in the development, maintenance, and worsening of ventricular arrhythmias. New treatment options in this population represent a clinical necessity. This study's objective was to report the outcomes of patients with ICDs and electrical storm submitted to renal sympathetic denervation for arrhythmia control.MethodsEight patients with ICDs admitted for electrical storm refractory to optimal medical therapy underwent renal sympathetic denervation. Underlying diseases included Chagas disease (n = 6), non‐ischemic dilated cardiomyopathy (n = 1), and ischemic cardiomyopathy (n = 1). Information on the number of episodes of ventricular tachycardia/ventricular fibrillation and antitachycardia therapies in the week before the procedure and 30 days after treatment were obtained through interrogation of the ICDs.ResultsThe median numbers of episodes of ventricular tachycardia/ventricular fibrillation, antitachycardia pacing, and shocks in the week before renal sympathetic denervation were 29 (9 to 106), 23 (2 to 94), and 7.5 (1 to 88), and significantly reduced to 0 (0 to 12), 0 (0 to 30), and 0 (0 to 1), respectively, 1 month after the procedure (p = 0.002; p = 0.01; p = 0.003, respectively). No patients died during follow‐up. There were no major complications related to the procedure.ConclusionsIn patients with ICDs and electrical storm refractory to optimal medical treatment, renal sympathetic denervation significantly reduced arrhythmia load and, consequently, antitachycardia pacing and shocks. Randomized clinical trials in the context of renal sympathetic denervation to control refractory cardiac arrhythmias are needed to further support these findings.

Aims To demonstrate the feasibility and efficacy of the novel InSeal VCD for the closure of large puncture holes following percutaneous structural interventions. Methods and results Prospective, non-randomised, single-arm, single-centre study with a series of patients submitted to endovascular treatment of abdominal and thoracic aortic aneurysm as well as transcatheter aortic valve implantation in whom the InSeal VCD was used to close the access site. These patients were followed up for one year with clinical examination, ankle-brachial index and Doppler ultrasound. The primary endpoint was the occurrence of major vascular complications at the puncture site. From a total of nine patients screened, seven were selected to receive the InSeal VCD. Technical and therapeutic successes were achieved in all cases. The sheath profiles used in these procedures ranged from 18 Fr to 25 Fr. No major vascular complications were observed during the follow-up period. Average ankle-brachial index pre-intervention and at one-month follow-up were 0.85 and 0.82, respectively. Conclusions The InSeal VCD was shown to be effective in achieving acute and chronic haemostasis after usage of higher profile endovascular devices in this study. These results translated into no clinical complications up to one-year clinical follow-up.

BackgroundDespite the better clinical performance of second-generation drug-eluting stents (DES) when compared to first-generation DES in controlled trials, mainly due to reduction in thrombosis rate, it remains unclear whether this benefit extends to diabetic patients treated in the daily practice. We sought to compare the clinical outcomes of unselected diabetic patients treated with either sirolimus eluting stents - SES (first-generation DES) or everolimus-eluting stents - EES (second-generation DES).MethodsBetween January 2007 and October 2014 a total of 798 diabetic patients were treated with SES (n = 414) and EES (n = 384). Long-term clinical follow-up was achieved in 99,4% of the population and the groups were compared regarding the occurrence of major adverse cardiac events (MACE) and stent thrombosis.ResultsIn both cohorts age was similar, and most patients were male. Stable coronary disease was the most frequent clinical presentation. The number of treated vessels (1.50 ± 0.62 vs. 1.52 ± 0.72; p = 0.88) and the total stent length (36.1 ± 20.4 vs. 37.7 ± 22.2mm; p = 0.32) were similar between groups. Patients treated with EES showed lower rates of MACE (15% vs. 6.8%, p < 0.001), mainly due to a lower cardiac death (5.3% vs. 1.3%, p < 0.001). There was also less definitive/ probable thrombosis with the second generation DES (3.4% vs. 0.5%, p = 0.004).ConclusionsIn this single center experience, the use of EES was associated with reduced cardiac death and stent thrombosis. This benefit was mostly observed in the long-term follow-up.

ResumoIntroduçãoStents farmacológicos (SF) de segunda geração demonstraram melhor desempenho clínico que os de primeira geração, sobretudo pela redução nas taxas de trombose, mas ainda não está claro se esse benefício se estende a diabéticos da prática diária. Objetivamos comparar o desempenho de pacientes diabéticos não selecionados tratados com SF eluidores de sirolimus (SES; primeira geração) vs. SF eluidores de everolimus (SEE; segunda geração).MétodosEntre 2007 e 2014, 798 diabéticos foram tratados com SES (n = 414) ou SEE (n = 384) e incluídos nesta análise. Seguimento clínico tardio foi obtido em 99,4% da população e os grupos foram comparados quanto à ocorrência de eventos cardíacos adversos maiores (ECAM) e trombose de stent.ResultadosA idade da população foi semelhante, com predomínio do sexo masculino. Em ambas as coortes, a apresentação clínica mais frequente foi a doença coronária estável. Número de vasos tratados (1,50 ± 0,62 vs. 1,52 ± 0,72; p = 0,88) e extensão total de stents (36,1 ± 20,4mm vs. 37,7 ± 22,2mm; p = 0,32) foram semelhantes. Os pacientes tratados com SEE apresentaram menores taxas de ECAM (15% vs. 6,8%; p < 0,001), sobretudo à custa de menor mortalidade cardíaca (5,3% vs. 1,3%; p < 0,001). Observou‐se também menor ocorrência de trombose de stent definitiva/provável com SF de segunda geração (3,4% vs. 0,5%; p = 0,004).ConclusõesNesta experiência unicêntrica, o uso de SEE em diabéticos mostrou‐se com menor mortalidade cardíaca e trombose da endoprótese. Esse benefício se fez mais evidente no seguimento mais tardio.AbstractBackgroundDespite the better clinical performance of second‐generation drug‐eluting stents (DES) when compared to first‐generation DES in controlled trials, mainly due to reduction in thrombosis rate, it remains unclear whether this benefit extends to diabetic patients treated in the daily practice. We sought to compare the clinical outcomes of unselected diabetic patients treated with either sirolimus eluting stents ‐ SES (first‐generation DES) or everolimus‐eluting stents ‐ EES (second‐generation DES).MethodsBetween January 2007 and October 2014 a total of 798 diabetic patients were treated with SES (n = 414) and EES (n = 384). Long‐term clinical follow‐up was achieved in 99,4% of the population and the groups were compared regarding the occurrence of major adverse cardiac events (MACE) and stent thrombosis.ResultsIn both cohorts age was similar, and most patients were male. Stable coronary disease was the most frequent clinical presentation. The number of treated vessels (1.50 ± 0.62 vs. 1.52 ± 0.72; p = 0.88) and the total stent length (36.1 ± 20.4 vs. 37.7 ± 22.2mm; p = 0.32) were similar between groups. Patients treated with EES showed lower rates of MACE (15% vs. 6.8%, p < 0.001), mainly due to a lower cardiac death (5.3% vs. 1.3%, p < 0.001). There was also less definitive/probable thrombosis with the second generation DES (3.4% vs. 0.5%, p = 0.004).ConclusionsIn this single center experience, the use of EES was associated with reduced cardiac death and stent thrombosis. This benefit was mostly observed in the long‐term follow‐up.

Fundamento: A tecnica radial reduz a prevalencia de complicacoes vasculares, sangramento grave e mortalidade quando cotejada a tecnica femoral. Entretanto, esta ainda predomina como via de acesso preferencial para a efetivacao de procedimentos coronarios invasivos, requerendo a adocao de estrategias capazes de minimizar intercorrencias. Objetivos: Comparar a sobrevida livre de eventos cardiovasculares adversos graves aos 12 meses de pacientes submetidos a estrategia intervencionista precoce pelo acesso radial ou femoral com dispositivo de oclusao vascular. Metodos: Estudo randomizado de nao inferioridade envolvendo 240 pacientes com sindrome coronariana aguda sem supradesnivel do segmento ST. A funcao de sobrevivencia livre de morte, infarto agudo do miocardio ou acidente vascular encefalico foi estimada pelo modelo de Kaplan-Meier e comparada utilizando-se o teste de log rank. Resultados: A taxa de complicacoes vasculares no sitio de puncao arterial aos 30 dias foi de 12,5% no grupo Angio-Seal e de 13,3% no grupo radial (p = 1,000). A incidencia de sangramento grave ou transfusao sanguinea aos 12 meses tambem nao diferiu entre os grupos (2,5% versus 1,7%, p = 1,000). Nao se observou diferenca quanto a curva de sobrevida livre de eventos cardiovasculares adversos graves (90,8% versus 94,2%, p = 0,328). Conclusoes: Nao houve distincao entre as tecnicas na sobrevida livre de eventos cardiovasculares adversos graves aos 12 meses de seguimento. Ensaios clinicos com maior poder estatistico sao necessarios para a validacao desses achados.

Thermoablation has been replacing conventional surgery in the surgical treatment of great saphenous vein (GSV) reflux in patients with lower limb varicose veins; however, thermoablation is expensive. Intravenous electrocoagulation (EC) may, selectively and safely, cause necrosis of the GSV wall, but the clinical results have never been studied. The objective of this study was to compare EC and radiofrequency ablation (RFA) in the treatment of GSV insufficiency, considering efficacy, complications, and effect on quality of life.This was a prospective, double-blind, randomized clinical trial. Patients with lower limb varicose veins and GSV reflux confirmed by duplex ultrasound were randomized into two treatment groups: EC and RFA. Patients were followed up at 1 week, 3 months, and 6 months after the procedure. Occlusion of the GSV confirmed by duplex ultrasound was considered the primary outcome, and the rate of complications and improvement in quality of life, using the Aberdeen Varicose Vein Questionnaire score, were the secondary outcomes.Fifty-seven patients were included, with a total of 85 treated GSVs; 43 were treated with RFA and 42 with EC. There was no statistically significant difference between the groups regarding age (P = .264), sex (P = .612), Aberdeen Varicose Vein Questionnaire score (P = .054), and diameter (P = .880) and depth (P = .763) of the treated GSV. In the intraoperative period, immediately after thermoablation, all GSVs treated with EC presented no flow and incompressibility in the treated segment, whereas 12 limbs still had flow in the treated GSV (P .001) and 9 veins showed compressibility (P .001) when treated with RFA. The main postoperative complication was paresthesia; however, there was no statistical significance between the groups (P = .320) regarding its presence. Time to return to routine activities was lower in the EC group than in the RFA group (P = .026). There was no difference between the groups at the 3-month (P = .157) and 6-month (P = .157) follow-up in occlusion of the GSV and improvement of the quality of life score (P = .786 and P = .401, respectively).EC has been shown to be an effective method for ablation of the GSV, with venous occlusion rate, occurrence of complications, and effect on quality of life similar to those with RFA.