Search

Background The FREEDOM (Future Revascularization Evaluation in Patients with Diabetes Mellitus: Optimal Management of Multivessel Disease) trial demonstrated that for patients with diabetes mellitus (DM) and multivessel coronary disease (MVD), coronary artery bypass grafting (CABG) is superior to percutaneous coronary intervention with drug-eluting stents (PCI-DES) in reducing the rate of major adverse cardiovascular and cerebrovascular events after a median follow-up of 3.8 years. It is not known, however, whether CABG confers a survival benefit after an extended follow-up period. Objectives The purpose of this study was to evaluate the long-term survival of DM patients with MVD undergoing coronary revascularization in the FREEDOM trial. Methods The FREEDOM trial randomized 1,900 patients with DM and MVD to undergo either PCI with sirolimus-eluting or paclitaxel-eluting stents or CABG on a background of optimal medical therapy. After completion of the trial, enrolling centers and patients were invited to participate in the FREEDOM Follow-On study. Survival was evaluated using Kaplan-Meier analysis, and Cox proportional hazards models were used for subgroup and multivariate analyses. Results A total of 25 centers (of 140 original centers) agreed to participate in the FREEDOM Follow-On study and contributed a total of 943 patients (49.6% of the original cohort) with a median follow-up of 7.5 years (range 0 to 13.2 years). Of the 1,900 patients, there were 314 deaths during the entire follow-up period (204 deaths in the original trial and 110 deaths in the FREEDOM Follow-On). The all-cause mortality rate was significantly higher in the PCI-DES group than in the CABG group (24.3% [159 deaths] vs. 18.3% [112 deaths]; hazard ratio: 1.36; 95% confidence interval: 1.07 to 1.74; p = 0.01). Of the 943 patients with extended follow-up, the all-cause mortality rate was 23.7% (99 deaths) in the PCI-DES group and 18.7% (72 deaths) in the CABG group (hazard ratio: 1.32; 95% confidence interval: 0.97 to 1.78; p = 0.076). Conclusions In patients with DM and MVD, coronary revascularization with CABG leads to lower all-cause mortality than with PCI-DES in long-term follow-up. (Comparison of Two Treatments for Multivessel Coronary Artery Disease in Individuals With Diabetes [FREEDOM]; NCT00086450)

We sought to develop a risk score to estimate the risk of major adverse cardiac event (MACE) occurrence during the in-hospital and long-term follow-up periods after percutaneous coronary intervention (PCI) with drug-eluting stent (DES) implantation.This score was developed and validated in a single-center database encompassing all consecutive patients treated with DES between 2007 and 2014 (n = 4061). For the development of the score, we analyzed all patients treated between January 2007 and December 2012 (n = 2863) while the validation was conducted in a cohort treated between January 2013 and December 2014 (n = 1198). MACE was defined as the combination of cardiovascular death, myocardial infarction, and ischemia- driven target-lesion revascularization. Different stratification models were developed for the in-hospital (logistic regression) and late follow-up score (Cox model).In-hospital scores ranged from 0 to 37 points and comprised: (a) age; (b) previous coronary artery bypass grafting (CABG); (c) acute coronary syndrome; (d) peripheral vascular disease; (e) treatment of saphenous vein graft; (f) long lesions; (g) small vessels; (h) multivessel disease; and (i) thrombus. The late scores ranged from 0 to 45 points and comprised: (a) previous CABG; (b) diabetes mellitus; (c) acute coronary syndrome; (d) multivessel disease; (e) small vessels; (f) ejection fraction40%; and (g) treatment of saphenous vein graft. Patients were stratified into low-risk, moderate-risk, and high-risk groups. Both scores had close to 70% accuracy for predicting MACE.The present score was developed and validated based on contemporary models for assessing periprocedural and long-term MACE risk post PCI, throughout the full spectrum of patient risk, and important patient subgroups.

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.

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 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

Background Alcohol septal ablation (ASA) is an alternative treatment for symptomatic hypertrophic obstructive cardiomyopathy (HOCM) patients refractory to pharmacological therapy. We sought to evaluate the immediate and long-term incidence of death and changes in life quality in a consecutive cohort submitted to ASA. Methods and Results Between October 1998 and December 2013, a total of 56 patients (mean age 53.2 ± 15.5) with symptomatic refractory HOCM were treated with ASA and followed during 15 years (mean 8 ± 4 years). There were 7 (12.5%) deaths, 2 (3.6%) being of cardiac cause. The Kaplan-Meier survival probability estimate was 96.4% at 1 year, 87.7 at 5 years and 81.0% at 12 years post-ASA. Significant improvement was observed in life quality assessed by DASI index and NYHA functional class as well as in the left ventricle outflow tract (LVOT) gradient reduction (from 92.8 ± 3.3 mm Hg to 9.37 ± 6.7 mm Hg, P

The endothelium has a central role in vascular response after percutaneous coronary intervention (PCI) with stents. Cellular and molecular mechanisms control the healing response after PCI, and the degree of this response is related to development of untoward events such as restenosis and device thrombosis. In this chapter, we briefly describe the cascade of events, which will ultimately result in stent endothelialization and different responses according to the device deployed: bare-metal vs. drug-eluting stents. Dysfunctional endothelial response, represented by pathologic vessel remodeling and delayed healing, is also addressed, as well as the potential inflammatory mechanism related to these devices. Finally, we briefly discuss the novel bioresorbable vascular scaffolds (BRS or bioabsorbable stent), and potential advantages to endothelium function that might arise from this new technology.

Background The MGuard TM stent, which has a microscopic polymer mesh coating, is intended to reduce the distal embolization of fragments during percutaneous coronary intervention (PCI) in saphenous vein grafts (SVG). This study evaluated the early and late clinical outcomes of patients undergoing PCI in SVG with MGuard TM stents vs. drug-eluting stents (DES). Methods Observational, retrospective study conducted at two tertiary centers, involving a cohort of patients with SVG lesions submitted to elective or emergency treatment with MGuard TM stents or DES. Results A total of 271 patients were included, of whom 220 were treated with DES. The MGuard TM group had a higher proportion of women (25.5% vs. 10.5%; p = 0.01), with a mean age of 65.0 ± 13.9 years vs. 69.0 ± 9.6 years ( p = 0.06). The DES group more frequently used distal protection filter (5.8% vs. 10.0%; p = 0.001). Angiographic success was attained in most cases (96.2% vs. 98.0%; p = 0.22). The MGuard TM group had lower rates of early major adverse cardiovascular events (MACE) than the DES group (1.9% vs. 13.6%; p = 0.01), due solely to the lower incidence of periprocedural infarction. However, the MACE rate at 1 year was higher in the MGuard TM group (14.3% vs. 4.4%; p = 0.01) at the expense of a higher rate of target lesion revascularization (7.1% vs. 1.3%; p = 0.048). Conclusions The use of the MGuard TM stent resulted in a reduction of events during hospitalization; however, in the long term the DES were superior in reducing major outcomes, mainly the need for target lesion revascularization.

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.

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.

BackgroundComplete 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).

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.

Appropriate use criteria (AUC) for coronary revascularization were developed to deliver high-quality care; however, the prognostic impact of these criteria remains unclear. We sought to assess the outcomes of patients treated with second-generation drug-eluting stent (DES) classified according to the updated American College of Cardiology Foundation/American Heart Association/Society for Cardiac Angiography and Intervention AUC for percutaneous coronary intervention (PCI).Between January 2012 and December 2013, a total of 1108 consecutive patients treated only with second-generation DES were categorized according to the AUC in three groups, using the new proposed terminology: appropriate ("A"); uncertain ("U"); and inappropriate ("I"). Major adverse cardiac event (MACE, defined as cardiac death, non-fatal myocardial infarction, and ischemia-driven target-lesion revascularization) and stent thrombosis up to 3 years were compared.PCI was categorized as A in 33.8%, U in 46.8%, and I in 19.4% of all cases. PCI-A patients had a higher prevalence of acute coronary syndromes, while PCI-I involved the treatment of more diabetics and patients with stable coronary disease. There were no differences in procedural complications among the three groups, with comparable rates of in-hospital MACE (9.3% for A vs 9.0% for U vs 7.0% for I; P=.70) and 2-year MACE (13.9% for A vs 9.0% for U vs 8.6% for I; P=.40). In the multivariable analysis, AUC classification was not associated with adverse outcomes.In this contemporary cohort of patients treated with second-generation DES implantation, AUC did not impact 3-year clinical follow-up.

Background: The impact of paravalvular regurgitation (PVR) following transcatheter aortic valve implantation (TAVI) remains uncertain. Objective: To evaluate the impact of PVR on mortality and hospital readmission one year after TAVI. Methods: Between January 2009 and June 2015, a total of 251 patients underwent TAVI with three different prostheses at two cardiology centers. Patients were assessed according to PVR severity after the procedure. Results: PVR was classified as absent/trace or mild in 92.0% (n = 242) and moderate/severe in 7.1% (n = 18). The moderate/severe PVR group showed higher levels of aortic calcification (22% vs. 6%, p = 0.03), higher serum creatinine (1.5 ± 0.7 vs. 1.2 ± 0.4 mg/dL, p = 0.014), lower aortic valve area (0.6 ± 0.1 vs. 0.7 ± 0.2 cm2, p = 0.05), and lower left ventricular ejection fraction (49.2 ± 14.8% vs. 58.8 ± 12.1%, p = 0.009). Patients with moderate/severe PVR had more need for post-dilatation (p = 0.025) and use of larger-diameter balloons (p = 0.043). At one year, all-cause mortality was similar in both groups (16.7% vs. 12%, p = 0.08), as well as rehospitalization (11.1% vs. 7.3%, p = 0.915). PVR grade significantly reduced throughout the first year after the procedure (p < 0.01). The presence of moderate/severe PVR was not associated with higher one-year mortality rates (HR: 0.76, 95% CI: 0.27-2.13, p = 0.864), rehospitalization (HR: 1.08, 95% CI: 0.25-4.69, p=0.915), or composite outcome (HR: 0.77, 95% CI: 0.28-2.13, p = 0.613). Conclusion: In this sample, moderate/severe PVR was not a predictor of long-term mortality or rehospitalization. (Arq Bras Cardiol. 2017; [online].ahead print, PP.0-0) Resumo Fundamento: O impacto da regurgitação paravalvular (RPV) após implante de valva aórtica transcateter (TAVI) permanece incerto. Objetivo: Analisar o impacto da RPV na mortalidade e re-hospitalização 1 ano após o TAVI. Métodos: Entre janeiro de 2009 e junho de 2015, 251 pacientes foram submetidos ao TAVI em dois centros cardiológicos com 3 diferentes próteses. Os pacientes foram analisados de acordo com a gravidade da RPV pós-procedimento. Resultados: RPV foi classificada como ausente/mínima ou discreta em 92,0% (n=242) dos pacientes e moderada/grave em 7,1% (n = 18). Os pacientes com RPV moderada/importante apresentaram maior grau de calcificação aórtica (22,0% vs. 6,0%; p = 0,03), creatinina sérica (1,53 ± 0,71 vs. 1,18 ± 0,43 mg/dL; p = 0,01), menor área valvar aórtica (0,61 ± 0,12 vs. 0.69 ± 0,17 cm2; p = 0,05) e menor fração de ejeção do ventrículo esquerdo (49,17±14,79% vs. 58,82±12,14%; p = 0,009). Nos pacientes com RPV moderada/importante a necessidade de pós-dilatação foi maior (p = 0,025) e eventualmente com balão de diâmetro maior (p = 0,04). Ao final de 1 ano, a mortalidade por todas as causas foi similar em ambos os grupos (16,7% vs. 12,0%; p = 0,08), assim como re-hospitalização (11,1% vs. 7,3%; p = 0,91). O grau de RPV ao longo do primeiro ano reduziu progressivamente (p < 0,01). A presença de RPV moderada/importante não foi associada a maiores taxas de mortalidade em 1 ano [RR (risco relativo): 0,76; IC (intervalo de confiança) 95%: 0,27-2,13; p = 0,864)], re-hospitalização (RR: 1,08; IC 95%: 0,25-4,69; p = 0,915) ou desfecho combinado (RR: 0,77; IC 95%: 0,28-2,13; p = 0,61). Conclusões: Nesta amostra, a presença de regurgitação paravalvular moderada/importante não foi um preditor de mortalidade ou reinternação a longo prazo. (Arq Bras Cardiol. 2017; [online].ahead print, PP.0-0)

Aim We sought to assess the long term efficacy of the novel VESTAsync™ Eluting Stent (VES) combining a Cro-Co platform with a nanothin-microporous hydroxyapatite surface coating impregnated with a polymer-free low-dose of Sirolimus (55 μg). Methods The Vestasync II trial was a randomized (2:1), double-blinded, multicenter comparison of the VES to its platform, the Gen X stent, with microporous hydroxyapatite surface coating without sirolimus. Patients were eligible if they presented de novo lesions in native coronary arteries with 3.0–3.5 mm diameter and ≤ 14 mm in length. Primary endpoint was 8-month in-stent late loss and % of stent obstruction. Lifelong aspirin and 6-month clopidogrel were prescribed to all patients. Results Seventy-five patients were enrolled (VES = 50 pts). Baseline characteristics included mean age of 58 years and 29% of diabetics. Reference vessel diameter and lesion length were 2.8 ± 0.4 mm and 13.0 ± 2.0 mm, respectively. In-stent late loss (0.39 ± 0.20 vs. 0.74 ± 0.52, P = 0.03) and % of neointima hyperplasia (9.3 ± 6.6% vs. 17.6 ± 9.4%, P = 0.0016) were significantly reduced in the VES cohort. Up to 1 year, there was a single case of myocardial infarction and one target lesion revascularization (TLR) (2%) in the VES group while in the control cohort there were one TLR (4%) and one cardiac death (4%). Conclusion The VestSync II trial is a proof-of-concept study and demonstrates the sustained efficacy of this novel polymer-free sirolimus drug-eluting stents. A larger trial, with more complex lesions, clinical endpoints and longer FU period is warranted. © 2013 Wiley Periodicals, Inc.

Fundamento: A hipertensão arterial sistêmica constitui importante problema de saúde pública e significativa causa de mortalidade cardiovascular. A elevada prevalência e as reduzidas taxas de controle tensional despertaram o interesse por estratégias terapêuticas alternativas. A denervação simpática renal percutânea surgiu como perspectiva no tratamento de hipertensos resistentes. Objetivo: Avaliar a factibilidade e a segurança da denervação renal com cateter irrigado. Métodos: Dez hipertensos resistentes foram submetidos ao procedimento. O desfecho primário foi a segurança, avaliada por eventos adversos periprocedimento, função renal e anormalidade vascular renal aos 6 meses. Os desfechos secundários constituíram mudanças na pressão arterial (consultório e monitorização ambulatorial) e no número de anti-hipertensivos aos 6 meses. Resultados: A média de idade foi de 47,3 (± 12) anos, 90% eram mulheres. No primeiro caso, houve dissecção de artéria renal causada por trauma da bainha, fato que não se repetiu após ajuste técnico, demonstrando efeito da curva de aprendizado. Nenhum caso de trombose/infarto renal ou óbito foi reportado. Não se observou elevação dos níveis séricos de creatinina durante o seguimento. Aos 6 meses, diagnosticou-se um caso de estenose significativa de artéria renal, sem repercussão clínica. A denervação renal reduziu a pressão arterial de consultório, em média, em 14,6/6,6 mmHg (p = 0,4 tanto para pressão arterial sistólica como para a diastólica). A redução média da pressão arterial pela monitorização ambulatorial foi de 28/17,6 mmHg (p = 0,02 e p = 0,07 para pressão arterial sistólica e diastólica, respectivamente). Houve redução média de 2,1 anti-hipertensivos. Conclusão: A denervação renal é factível e segura no tratamento da hipertensão arterial sistêmica resistente. Estudos maiores são necessários para confirmar nossos resultados. Background: Systemic hypertension is an important public health problem and a significant cause of cardiovascular mortality. Its high prevalence and the low rates of blood pressure control have resulted in the search for alternative therapeutic strategies. Percutaneous renal sympathetic denervation emerged as a perspective in the treatment of patients with resistant hypertension. Objective: To evaluate the feasibility and safety of renal denervation using an irrigated catheter. Methods: Ten patients with resistant hypertension underwent the procedure. The primary endpoint was safety, as assessed by periprocedural adverse events, renal function and renal vascular abnormalities at 6 months. The secondary endpoints were changes in blood pressure levels (office and ambulatory monitoring) and in the number of antihypertensive drugs at 6 months. Results: The mean age was 47.3 (± 12) years, and 90% of patients were women. In the first case, renal artery dissection occurred as a result of trauma due to the long sheath; no further cases were observed after technical adjustments, thus showing an effect of the learning curve. No cases of thrombosis/renal infarction or death were reported. Elevation of serum creatinine levels was not observed during follow-up. At 6 months, one case of significant renal artery stenosis with no clinical consequences was diagnosed. Renal denervation reduced office blood pressure levels by 14.6/6.6 mmHg, on average (p = 0.4 both for systolic and diastolic blood pressure). Blood pressure levels on ambulatory monitoring decreased by 28/17.6 mmHg (p = 0.02 and p = 0.07 for systolic and diastolic blood pressure, respectively). A mean reduction of 2.1 antihypertensive drugs was observed. Conclusion: Renal denervation is feasible and safe in the treatment of resistant systemic arterial hypertension. Larger studies are required to confirm our findings.

INTRODUÇÃO: Suportes vasculares bioabsorvíveis (SVB) têm sido desenvolvidos como forma de fornecer sustentação à parede do vaso enquanto ocorre o processo de cicatrização, após a intervenção coronária percutânea (ICP), sendo absorvido posteriormente. Pelo fato da plataforma ser de material polimérico, existe preocupação em relação à retração aguda do dispositivo. Avaliamos aqui a retração aguda do SVB com a de dois diferentes stents farmacológicos metálicos. MÉTODOS: Foram incluídos 50 pacientes com lesões não complexas. Dentre esses pacientes, 25 foram tratados com SVB e comparados a outros 25 pacientes tratados com stent de cromo-cobalto eluidor de everolimus (EES; n = 12) ou stent de aço inoxidável eluidor de biolimus (BES; n = 13). A retração aguda foi definida como a diferença entre o diâmetro médio do balão durante a pressão máxima de inflação (X) e o diâmetro médio do stent após o esvaziamento do balão (Y). A porcentagem de retração aguda foi definida como (X - Y)/X. RESULTADOS: Não houve diferença significativa em relação às características clínicas e angiográficas basais. O ganho luminal agudo foi menor com o SVB comparado ao EES e ao BES (1,51 ± 0,41 mm vs. 1,76 ± 0,28 mm vs. 1,9 ± 0,42 mm; P = 0,02). A retração aguda foi de 0,21 ± 0,13 mm vs. 0,15 ± 0,08 mm vs. 0,14 ± 0,08 mm (P = 0,21), e o porcentual de retração aguda foi de 7,0 ± 4,6% vs. 5,0 ± 2,2% vs. 5,7 ± 4,1% (P = 0,16). CONCLUSÕES: O SVB demonstrou ter retração aguda ligeiramente maior, embora não significativa, que os stents metálicos farmacológicos de segunda geração.

FUNDAMENTO: Na angioplastia coronária percutânea (ACP), os vasos de fino calibre representam um fator de risco para reestenose. O stent farmacológico (SF) autoexpansível Sparrow®, de perfil menor que os sistemas atuais, nunca foi testado nesse cenário. OBJETIVOS: Avaliar a eficácia tardia do SF Sparrow®, com relação à perda luminal tardia intrastent (PLT intrastent) aos oito meses. MÉTODOS: Estudo prospectivo, randomizado, em P com doença arterial coronária (DAC) sintomática ou com isquemia documentada, submetido à ACP em vasos de calibre < 2,75 mm, dividido em dois grupos quanto ao tipo de stent Sparrow®: grupo 1, SF; grupo 2, stent não farmacológico (SNF). O seguimento clínico foi de 12 meses. De imediato e aos oito meses, avaliação pela angiografia coronária quantitativa (ACQ). Para o cálculo da amostra estimou-se diminuição de mais de 65% de PLT intrastent com o SF. Para análise estatística utilizou-se o programa IBM SPSS Statistics® versão 19 (Chicago, Illinois, EUA). RESULTADOS: Foram incluídos 24 p, 12 em cada grupo. Os grupos SF e SNF foram semelhantes quanto à idade (63,25 ± 10,01 versus 64,58 ± 11,54, p = 0,765), sexo masculino (58,3% versus 33,3%, p = 0,412), fatores de risco e todos os aspectos angiográficos. Os resultados imediatos foram satisfatórios em ambos os grupos. Aos oito meses, a PLT intrastent foi significativamente menor no SF do que no SNF (SF 0,25 ± 0,16 versus SNF 0,97 ± 0,76, p = 0,008). CONCLUSÃO: Em ACP de vasos de calibre < 2,75 mm, o SF Sparrow® determinou significativa redução da PLT intrastent, em comparação ao SNF Sparrow®. BACKGROUND: Small vessels represent a risk factor for restenosis in percutaneous coronary angioplasty (PCA). The Sparrow® self-expanding drug-eluting stent, which has a lower profile than the current systems, has never been tested in this scenario. OBJECTIVES: To evaluate the late effectiveness of the Sparrow® drug-eluting stent, regarding in-stent late lumen loss (LLL). METHODS: Patients with ischemia, symptomatic or documented, were submitted to PCA in vessels with reference diameter < 2.75 mm, divided into two groups regarding Sparrow® stent type: group 1: Sparrow® drug-eluting stent (DES), group 2: Sparrow® bare metal stent (BMS). Clinical follow-up duration was 12 months. Evaluation using quantitative coronary angiography (QCA) was performed immediately and at 8 months. A decrease of over 65% of in-stent LLL with DES was estimated to calculate sample size. IBM® SPSS software, release 19 (Chicago, Illinois, USA) was used for the statistical analysis. RESULTS: A total of 24 patients were randomized, 12 in each group. The DES and BMS groups were similar in age (63.25 ± 10.01 vs. 64.58 ± 11.54, p = 0.765), male gender (58.3% vs. 33.3%, p = 0.412), risk factors and all angiographs aspects. Immediate results were satisfactory in both groups. At 8 months in-stent late lumen loss was significantly lower in DES than in BMS group (DES vs. BMS 0.25 ± 0.16 0.97 ± 0.76, p = 0.008). CONCLUSION: In small-vessel PCA, the Sparrow® DES determined significant reduction in in-stent LLL, when compared to Sparrow® BMS.

To investigate vessel remodeling and plaque distribution in side branch (SB) of true coronary bifurcation lesions with SB disease extending from its ostium. A total of 62 patients with single de novo true bifurcation lesions with SB with severe and extensive disease were enrolled. Of that, 45 patients/lesions underwent pre-intervention intravascular ultrasound (IVUS) at the SB. Left anterior descending was the most prevalent target vessel (85%). All lesions had significant involvement of both branches of the bifurcation, and the majority were classified as type 1,1,1 according to the Medina classification. Considering the subset with IVUS imaging, mean lesion length, reference diameter and % diameter stenosis in the SB were 8.88 ± 4.61 mm, 2.68 ± 0.59, and 70.2 ± 16.0%, respectively. Also, mean proximal (take-off) and distal (carina) angles were 142.3 ± 21.9° and 60.7 ± 22.4°, respectively. At minimum lumena area (MLA) site, mean external elastic membrane and MLA cross-sectional areas were 6.70 ± 2.08 and 1.87 ± 0.93 mm2, respectively; given that the mean distance measured between the SB origin and MLA site was1 mm. In addition, mean plaque burden was 67.9% and mean remodeling index was 0.78 ± 0.21. Importantly, only 9 cases out of 45 presented remodeling index1.0. Also, plaque distribution analysis within the SB ostium demonstrated preferable plaque positioning in the opposite side to the flow divider. In conclusions, significant negative remodeling is a frequent encounter in SB of complex coronary bifurcation lesions presenting with extensive and severe disease; in addition, plaque distribution in the SB ostium appears to be asymmetric in relation to the parent vessel, as plaque burden is mostly found in regions of low wall shear stress including the opposite side to the flow divider within the bifurcation anatomy.

INTRODUÇÃO: A incidência de refluxo paraprotético (RPP) parece maior entre os pacientes submetidos a implante de prótese aórtica transcateter e sua potencial associação com aumento da mortalidade tardia tem suscitado preocupação na comunidade científica. Nosso objetivo foi avaliar a incidência e o impacto clínico e estabelecer preditores do RPP em nossa casuística. MÉTODOS: Entre julho de 2009 e fevereiro de 2013, 112 pacientes foram submetidos a implante de prótese aórtica transcateter. O grau do RPP pós-procedimento foi avaliado segundo os critérios do VARC 2. Dividiu-se a população em grupo RPP ausente/RPP discreto e grupo RPP moderado/RPP grave. RESULTADOS: A média da idade foi de 82,5 ± 3,9 anos, 58,9% eram do sexo feminino e o EuroSCORE logístico foi de 23,6 ± 13,4. Houve queda do gradiente sistólico médio (54,7 ± 15,3 mmHg vs. 11,7 ± 4 mmHg; P < 0,01) e ganho da área valvar aórtica (0,66 ± 0,15 cm² vs. 1,8 ± 0,3 cm²; P < 0,01). Ao final do procedimento, 46,4% não apresentaram RPP, e RRP discreto ou moderado foi observado em 42% e 11,6% dos pacientes. Nenhum paciente apresentou RPP grave. A análise multivariada identificou sexo masculino [odds ratio (OR) 5,85, intervalo de confiança (IC] 1,29-26,7; P = 0,022), valvoplastia aórtica percutânea prévia (OR 18,44, IC 2,30-147,85; P = 0,006), fração de ejeção < 35% (OR 4,160, IC 1,014-17,064; P = 0,048) e presença de hipertensão pulmonar grave (OR 7,649, IC 1,86-31,51; P = 0,005) como preditores independentes de RPP moderado/grave. CONCLUSÕES: A incidência de RPP moderado/grave foi baixa e comparável à de outras casuísticas. Sexo masculino, antecedente de valvoplastia aórtica percutânea prévia, presença de hipertensão pulmonar grave e disfunção ventricular esquerda grave foram preditores independentes dessa complicação.

Relatamos série de 5 pacientes internados por síndrome coronária aguda, entre 2008 e 2010, nos quais a cinecoronariografia evidenciou dissecção coronária espontânea. A dissecção coronária espontânea é uma causa rara de infarto do miocárdio, mais comumente observada em indivíduos jovens e sem histórico de doenças cardiovasculares. O manejo ideal é incerto, principalmente pela limitada experiência clínica com essa entidade. A ultrassonografia intracoronária é uma ferramenta útil tanto para o diagnóstico da dissecção coronária espontânea como para guiar o tratamento percutâneo. We report a series of five patients hospitalized due to acute coronary syndrome, from 2008 to 2010, in whom coronary angiography showed spontaneous coronary dissection. Spontaneous coronary artery dissection is a rare cause of acute myocardial infarction, most commonly seen in young individuals with no history of cardiovascular disease. The optimal management is uncertain, especially due to the limited clinical experience with this entity. Intravascular ultrasound is a useful tool to diagnose spontaneous coronary artery dissection as well as to guide percutaneous therapy.

INTRODUÇÃO: O tipo de proteção cerebral utilizado durante o implante de stent carotídeo é controverso em idosos. Nosso objetivo foi avaliar os resultados dos dispositivos de proteção embólica cerebral (PEC), proximal e distal, em pacientes > 70 anos de idade, por meio da ressonância magnética ponderada de difusão (RM-PD). MÉTODOS: Entre 2008 e 2011, 60 pacientes com indicação de stent carotídeo foram randomizados para PEC com Mo.Ma® ou Angioguard®, dos quais 26 tinham > 70 anos de idade. Os resultados da RM-PD realizada antes e 48 horas após o procedimento foram avaliados por neurologista independente e cego para o tipo de PEC utilizado. Foram analisados o número de novos focos isquêmicos, sua localização e o tamanho. RESULTADOS: Novos focos isquêmicos cerebrais foram encontrados em 8/12 (66,7%) pacientes do grupo Mo.Ma® e em 12/14 (85,7%) pacientes do grupo Angioguard® (P = 0,37). A maioria das lesões (> 90%) era ipsilateral à artéria tratada em ambos os grupos, e o tamanho das lesões foi < 0,5 cm na maioria dos casos. O número de lesões por paciente foi menor com o dispositivo Mo.Ma® (mediana [variação]: 3 [1 a 8] lesões vs. 15 [2 a 76] lesões; P < 0,001). Todos os pacientes que tiveram mais de 40 lesões pertenciam ao grupo Angioguard®. CONCLUSÕES: Mesmo utilizando PEC (proximal ou distal), novas lesões isquêmicas foram observadas em ambos os grupos em pacientes idosos. Proporcionalmente maior número de pacientes com Angioguard® teve novos focos isquêmicos se comparados aos pacientes do grupo Mo.Ma®. O dispositivo de PEC Mo.Ma® parece diminuir o número de lesões por paciente. BACKGROUND: The type of cerebral protection used during carotid stenting in the elderly is controversial. Our objective was to evaluate the results of proximal and distal cerebral embolic protection devices (EPDs), in patients > 70 years through diffusion-weighted magnetic resonance imaging (DW-MRI). METHODS: Between 2008 and 2011, 60 patients with indication for carotid stenting were randomized to EPD with Mo.Ma® or Angioguard®, of which 26 patients were > 70 years of age. Results of DW-MRI performed before and 48 hours after the procedure were evaluated by an independent neurologist blinded to the type of EPD used. New ischemic lesions, their localization and size were analyzed. RESULTS: New cerebral ischemic lesions were found in 8/12 (66.7%) patients in the Mo.Ma® group and 12/14 (85.7%) patients in the Angioguard® group (P = 0.37). The vast majority of the lesions (> 90%) were ipsilateral to the treated artery in both groups and the size of the lesions was < 0.5 cm in most cases. The number of lesions per patient was lower with the Mo.Ma® device (median [variation]: 3 [1 to 8] lesions vs 15 [2 to 76] lesions; P < 0.001). All of the patients with more than 40 lesions were in the Angioguard® group. CONCLUSIONS: Despite the use of EPDs (proximal or distal), new ischemic lesions were observed in both groups in elderly patients. A proportionately larger number of patients with Angioguard® had new ischemic lesions when compared to those with Mo.Ma®. The Mo.Ma® device seems to decrease the number of lesions per patient.

INTRODUÇÃO: A intervenção coronária percutânea (ICP) em pontes de safena ainda representa um desafio à cardiologia intervencionista, pelas complicações agudas e pela escassez de dados referentes à efetividade tardia dos stents farmacológicos (SFs). MÉTODOS: Entre maio de 2002 e janeiro de 2013, pacientes submetidos a ICP com SF no Hospital do Coração foram incluídos no Registro DESIRE. Avaliamos os resultados de pacientes submetidos a ICP em pontes de safena (grupo 1), que foram comparados aos submetidos a ICP em vasos nativos (grupo 2). RESULTADOS: De um total de 4.655 pacientes, 311 foram incluídos no grupo 1 e 4.344, no grupo 2. O grupo 1 contou com pacientes mais idosos (68,4 ± 9,7 anos vs. 64 ± 11,2 anos; P < 0,01), com mais pacientes do sexo masculino (87,1% vs. 76,7%; P < 0,01) e com maior incidência de comorbidades. Angina instável foi a apresentação clínica mais frequente nesse grupo. Pacientes do grupo 1 receberam stents de maior calibre (3,18 ± 1,11 mm vs. 2,86 ± 0,43 mm; P < 0,01) e foram submetidos menos frequentemente a pré-dilatação (36,3% vs. 50,7%; P < 0,01) e a pós-dilatação (38,3% vs. 58,4%; P < 0,01). Apresentaram mais infarto agudo do miocárdio não-fatal na fase hospitalar (11,3% vs. 4,1%; P < 0,01) e mais eventos cardiovasculares adversos maiores na fase tardia (32,8% vs. 13,9%; P < 0,01), à custa de óbito cardíaco (7,7% vs. 3,2%; P = 0,02) e de revascularização da lesão-alvo (9% vs. 4,3%; P < 0,01). Trombose definitiva do stent foi mais frequente no grupo 1 (3,5% vs. 1%; P < 0,01). CONCLUSÕES: A despeito do inquestionável benefício dos SFs nos resultados tardios de ICP em pacientes complexos, o tratamento de pacientes com lesões em pontes de safena ainda permanece um desafio, com resultados agudos e tardios menos favoráveis que os de pacientes com lesões em vasos nativos.

First generation drug-eluting stents (DES) are associated with reduced in-stent restenosis but significant increased risk of very late stent thrombosis (VLST). The absence of polymer in DES systems may reduce the occurrence of VLST. Optic coherence tomography (OCT) has been used for stent analysis as a surrogate safety endpoint. This study aimed to assess the long-term follow up of strut apposition and tissue coverage of BioMatrix DES by OCT. 20 patients undergoing BioMatrix DES (n = 15) or S-Stent BMS (n = 5) implantation were followed for at least 5 years and evaluated by quantitative coronary angiography, intravascular ultrasound, and OCT. The difference between the stent types was evaluated by nonparametric Mann-Whitney U test while categorical variables were evaluated by Fisher exact test. Rates of in-stent late loss were similar between groups [0.40 (0.21;0.77) vs. 0.68 (0.66; 0.82) mm, p = 0.205, for BioMatrix and S-Stent, respectively]. The vessel, stent and lumen volumes did not differ between groups. Patients treated with BioMatrix had significantly less stent obstruction [5.6 (4.4;9.7) vs. 28.6 (24.7;29.0) %, p = 0.001]. OCT analysis of 12 stents (Biomatrix = 9 and S-Stent = 3) demonstrated 126 (8.7 %) uncovered struts in the BioMatrix group compared to 23 (4.0 %) in the S-Stent group (p = 0.297), being the majority of them well apposed (117/126 and 21/23, respectively, p = 0.292). Only 9 (0.6 %) struts in the DES and 2 (0.4 %) struts in the BMS groups were simultaneously uncovered and malapposed (p = 0.924). BioMatrix DES was associated with lower rates of in-stent obstruction, and similar percentage of neointimal coverage on struts and of complete strut apposition.

Background The embolization of atheroma/thrombus fragments during percutaneous coronary intervention (PCI) causes microcirculatory perfusion disturbances. The new MGuard™, a mesh-based bare-metal stent, demonstrated efficacy in the prevention of embolic complications during primary PCI. However, the late clinical outcome of patients treated with the MGuard™ stent remains unknown. Methods A series of 65 patients with de novo coronary lesions treated with MGuard™ stent was analyzed. Baseline clinical data, procedure and late clinical follow-up (mean duration, 2.6 ± 1.4 years) data were collected retrospectively by a review of medical records and/ or direct telephone contact. Results Mean age was 66.1 ± 13.7 years, 32.3% of patients were diabetic, 49.2% had a previous acute myocardial infarction (AMI), and 44.6% presented with acute coronary syndrome. Two thirds of the lesions were located in a saphenous vein graft, almost half of the lesions had thrombus and most were classified as type B2/C. The MGuard™ stent was successfully implanted in all cases. At the end of the procedure, TIMI 3 flow was achieved in 93.4% and angiographic success was 91.8%. In the late clinical follow- up, adverse event rates included cardiac death in 6.2%, nonfatal AMI in 9.2%, target lesion revascularization in 9.2% and definite/probable stent thrombosis in 1.5%. Conclusions The late follow-up of patients with complex coronary lesions treated with the MGuard™ stent demonstrated low rates of target lesion revascularization and stent thrombosis.

INTRODUÇÃO: A incidência de refluxo paraprotético (RPP) parece maior entre os pacientes submetidos a implante de prótese aórtica transcateter e sua potencial associação com aumento da mortalidade tardia tem suscitado preocupação na comunidade científica. Nosso objetivo foi avaliar a incidência e o impacto clínico e estabelecer preditores do RPP em nossa casuística. MÉTODOS: Entre julho de 2009 e fevereiro de 2013, 112 pacientes foram submetidos a implante de prótese aórtica transcateter. O grau do RPP pós-procedimento foi avaliado segundo os critérios do VARC 2. Dividiu-se a população em grupo RPP ausente/RPP discreto e grupo RPP moderado/RPP grave. RESULTADOS: A média da idade foi de 82,5 ± 3,9 anos, 58,9% eram do sexo feminino e o EuroSCORE logístico foi de 23,6 ± 13,4. Houve queda do gradiente sistólico médio (54,7 ± 15,3 mmHg vs. 11,7 ± 4 mmHg; P < 0,01) e ganho da área valvar aórtica (0,66 ± 0,15 cm² vs. 1,8 ± 0,3 cm²; P < 0,01). Ao final do procedimento, 46,4% não apresentaram RPP, e RRP discreto ou moderado foi observado em 42% e 11,6% dos pacientes. Nenhum paciente apresentou RPP grave. A análise multivariada identificou sexo masculino [odds ratio (OR) 5,85, intervalo de confiança (IC] 1,29-26,7; P = 0,022), valvoplastia aórtica percutânea prévia (OR 18,44, IC 2,30-147,85; P = 0,006), fração de ejeção < 35% (OR 4,160, IC 1,014-17,064; P = 0,048) e presença de hipertensão pulmonar grave (OR 7,649, IC 1,86-31,51; P = 0,005) como preditores independentes de RPP moderado/grave. CONCLUSÕES: A incidência de RPP moderado/grave foi baixa e comparável à de outras casuísticas. Sexo masculino, antecedente de valvoplastia aórtica percutânea prévia, presença de hipertensão pulmonar grave e disfunção ventricular esquerda grave foram preditores independentes dessa complicação. BACKGROUND: The incidence of paravalvular aortic regurgitation (PAR) seems higher among patients submitted to transcatheter aortic valve implantation and its potential association with an increased late mortality has raised concerns in the scientific community. Our objective was to evaluate the incidence and clinical impact of PAR and establish PAR predictors in our patient population. METHODS: Between July/2009 and February/2013, 112 patients were submitted to transcatheter aortic valve implantation. The degree of PAR after the procedure was assessed according to the VARC 2 criteria. The population was divided into no/mild PAR group and moderate/severe PAR group. RESULTS: Mean age was 82.5 ± 3.9 years, 58.9% were female and the logistic EuroSCORE was 23.6 ± 13.4. There was a decrease in the mean systolic gradient (54.7 ± 15.3 mmHg vs 11.7 ± 4 mmHg; P < 0.01) and a gain in the aortic valve area (0.66 ± 0.15 cm² vs 1.8 ± 0.3 cm²; P < 0.01). At the end of the procedure 46.4% did not have PAR, and mild or moderate PAR was observed in 42% and 11.6% of the patients. No patient presented severe PAR. Multivariate analysis identified male gender [odds ratio (OR) 5.85, confidence interval (CI] 1.29-26.7; P = 0.022), previous percutaneous aortic valvuloplasty (OR 18.44, CI 2.30-147.85; P = 0.006), ejection fraction < 35% (OR 4.160, CI 1.014-17.064; P = 0.048) and the presence of severe pulmonary hypertension (OR 7.649, CI 1.86-31.51; P = 0.005) as independent predictors of moderate/severe PAR. CONCLUSIONS: The incidence of moderate/severe PAR was low and comparable to other studies. Male gender, history of prior percutaneous aortic valvuloplasty, presence of severe pulmonary hypertension and severe left ventricular dysfunction were independent predictors of this complication.

Background Renal sympathetic denervation (RSD) is a promising strategy in the treatment of resistant hypertension. No studies have assessed the effect of RSD on quality of life in our country, which was the aim of this study. Methods The EuroQol5 Dimensions questionnaire (EQ5D5L) was chosen to evaluate quality of life in 10 patients undergoing RSD, and it was applied before and 3 months after the procedure. Results Mean age was 47.3 ± 12 years and 90% of the patients were female. Baseline blood pressure was 187 ± 37.5/104 ± 18.5 mmHg and the number of antihypertensive drugs was 7.6 ± 1.3. Before the procedure, the value assigned to health status was 37.5 ± 22.7, increasing at 3 months to 70.5 ± 20.9 (P = 0.01). In the follow-up, in addition to a decrease in the number of antihypertensive drugs (7.6 ± 1.3 vs. 6 ± 2.2; P = 0.05), a trend towards reduced levels of systolic blood pressure (187 ± 36 mmHg vs 170 ± 44 mmHg; P = 0.10) and diastolic blood pressure (104 ± 18 mmHg vs 98 ± 20 mmHg; P = 0.20) was observed. Health status improvement resulted from a reduction of problems related to mobility, usual activities, pain/discomfort and anxiety/depression. The magnitude of blood pressure reduction was not associated with improved quality in all of the patients. On the other hand, those who had a decrease in the number of antihypertensive drugs reported a better health status. Conclusions Patients with resistant hypertension have poor health status scores. RSD improved quality of life in most patients. Further studies are required to confirm consistent benefits.

INTRODUÇÃO: A intervenção coronária percutânea (ICP) por via radial ainda é pouco utilizada em nosso meio. Avaliaram-se aqui os resultados da ICP por via radial, realizada em um hospital terciário, que, progressivamente, tem incorporado tal técnica à prática clínica diária. MÉTODOS: Estudo retrospectivo, de pacientes tratados entre 2007 e 2012, no Instituto Dante Pazzanese de Cardiologia. Compararam-se os perfis clínico, angiográfico e do procedimento e os resultados hospitalares dos pacientes tratados por via radial com doença arterial coronária (DAC) estável e instável. RESULTADOS: Foram incluídos 2.507 pacientes, sendo 72,6% portadores de DAC estável e 27,4% de DAC instável. Os pacientes portadores de DAC estável tinham perfil clínico mais complexo, caracterizado por serem mais idosos, mais frequentemente do sexo feminino e com maior incidência de comorbidades. As características angiográficas e do procedimento não mostraram diferenças na maioria das varáveis analisadas. A taxa de sucesso foi elevada, porém maior no grupo DAC estável (94,6% vs. 92,4%; P = 0,05). A incidência de óbito (0,2% vs. 0,3%; P = 0,61), infarto periprocedimento (4,7% vs. 6,6%; P = 0,07), acidente vascular cerebral (0,1% vs. 0,1%; P > 0,99), ICP (0,1% vs. 0,3%; P = 0,30), cirurgia de revascularização miocárdica (0 vs. 0,4%; P = 0,06), sangramento maior (0,2% vs. 0,6%; P = 0,09) ou complicação vascular (1% vs. 0,6%; P = 0,47) foi baixa e não diferiu entre os grupos. CONCLUSÕES: ICP por via radial mostrou-se segura e eficaz, tanto em pacientes com DAC estável como instável, tratados em hospital terciário que progressivamente tem incorporado essa técnica à rotina diária. BACKGROUND: The transradial approach for percutaneous coronary intervention (PCI) is still not widely used in our country. We evaluated the results of transradial PCI performed at a tertiary hospital, which has progressively incorporated this technique to its daily clinical practice. METHODS: This is a retrospective study of patients treated from 2007 to 2012 at Instituto Dante Pazzanese de Cardiologia. Clinical, angiographic and procedural profile and in-hospital outcomes of patients with stable and unstable coronary artery disease (CAD) treated with the transradial approach were compared. RESULTS: We included 2,507 patients, of which 72.6% had stable and 27.4% had unstable CAD. Patients with stable CAD had a more complex clinical profile, characterized by being older, more frequently females, with a higher incidence of comorbidities. The angiographic and procedural characteristics were not different for most of the variables analyzed. The success rate was high, but higher in the stable CAD group (94.6% vs. 92.4%; P = 0.05). The incidence of death (0.2% vs. 0.3%; P = 0.61), peri-procedural infarction (4.7% vs. 6.6%; P = 0.07), stroke (0.1% vs. 0.1%; P > 0.99), PCI (0.1% vs. 0.3%; P = 0.30), coronary artery bypass graft (0 vs. 0.4%; P = 0.06), major bleeding (0.2% vs. 0.6%; P = 0.09) or vascular complications (1% vs. 0.6%; P = 0.47) was low and did not differ between groups. CONCLUSIONS: Transradial PCI has proved to be safe and effective in patients with stable and unstable CAD, treated at a tertiary hospital that has progressively incorporated this technique to its daily practice.

INTRODUÇÃO: A intervenção coronária percutânea (ICP) por via radial ainda é pouco utilizada em nosso meio. Avaliaram-se aqui os resultados da ICP por via radial, realizada em um hospital terciário, que, progressivamente, tem incorporado tal técnica à prática clínica diária. MÉTODOS: Estudo retrospectivo, de pacientes tratados entre 2007 e 2012, no Instituto Dante Pazzanese de Cardiologia. Compararam-se os perfis clínico, angiográfico e do procedimento e os resultados hospitalares dos pacientes tratados por via radial com doença arterial coronária (DAC) estável e instável. RESULTADOS: Foram incluídos 2.507 pacientes, sendo 72,6% portadores de DAC estável e 27,4% de DAC instável. Os pacientes portadores de DAC estável tinham perfil clínico mais complexo, caracterizado por serem mais idosos, mais frequentemente do sexo feminino e com maior incidência de comorbidades. As características angiográficas e do procedimento não mostraram diferenças na maioria das varáveis analisadas. A taxa de sucesso foi elevada, porém maior no grupo DAC estável (94,6% vs. 92,4%; P = 0,05). A incidência de óbito (0,2% vs. 0,3%; P = 0,61), infarto periprocedimento (4,7% vs. 6,6%; P = 0,07), acidente vascular cerebral (0,1% vs. 0,1%; P > 0,99), ICP (0,1% vs. 0,3%; P = 0,30), cirurgia de revascularização miocárdica (0 vs. 0,4%; P = 0,06), sangramento maior (0,2% vs. 0,6%; P = 0,09) ou complicação vascular (1% vs. 0,6%; P = 0,47) foi baixa e não diferiu entre os grupos. CONCLUSÕES: ICP por via radial mostrou-se segura e eficaz, tanto em pacientes com DAC estável como instável, tratados em hospital terciário que progressivamente tem incorporado essa técnica à rotina diária.

Transcatheter Aortic Valve Implantation for the Treatment of Severe Aortic Valve Stenosis in Inoperable Patients under the Perspective of the Brazilian Supplemental Health System Cost-Effectiveness Analysis Background: Transcatheter aortic valve implantation (TAVI) is a new modality of treatment especially dedicated to patients with high surgical risk. In these patients, TAVI increased survival and improved quality of life when compared to standard treatment (drug therapy with or without percutaneous aortic balloon valvuloplasty). Our objective was to perform a cost-efficacy analysis of the implementation of TAVI in the Brazilian Supplemental Health System. Methods: We developed a predictive model to assess the cost-effectiveness of the procedure in the long-term, and a Weibull regression analysis with a time horizon of 5 and 10 years, to estimate survival data for over 24 months. In addition, a deterministic sequential Markov model was developed. Results were expressed as incremental cost-effectiveness ratio (ICER) per years of life saved and progression-free years of life. Results: In a standard scenario

BackgroundThe type of cerebral protection used during carotid stenting in the elderly is controversial. Our objective was to evaluate the results of proximal and distal cerebral embolic protection devices (EPDs), in patients>70 years through diffusion-weighted magnetic resonance imaging (DW-MRI).MethodsBetween 2008 and 2011, 60 patients with indication for carotid stenting were randomized to EPD with Mo.Ma® or Angioguard®, of which 26 patients were>70 years of age. Results of DW-MRI performed before and 48 hours after the procedure were evaluated by an independent neurologist blinded to the type of EPD used. New ischemic lesions, their localization and size were analyzed.ResultsNew cerebral ischemic lesions were found in 8/12 (66.7%) patients in the Mo.Ma® group and 12/14 (85.7%) patients in the Angioguard® group (P=0.37). The vast majority of the lesions (> 90%) were ipsilateral to the treated artery in both groups and the size of the lesions was

BackgroundThe conformability of the stent, defined as the adaptation of the prosthesis to the natural shape of the vessel, is the major cause of geometrical changes after stenting and is influenced by the stent material and design. It may be assessed by measuring changes in the curvature and the angulation of the treated segment after stent implantation. The objective of this study was to compare changes in coronary angulation after implantation of the bioresorbable vascular scaffold (BVS) and cobalt-chromium and stainless steel metal platforms used in second-generation drug-eluting stents.MethodsIn this retrospective analysis, 50 patients with single de novo lesions in native coronary arteries and diameter between 2.5 and 3.5mm and length up to 23mm were included. Twenty-five patients were treated with BVS and 25 patients were treated with cobalt-chromium (n=12) or stainless steel (n=13) platforms. Angulation was measured using a dedicated quantitative angiography analysis software.ResultsVessel angulation significantly changed after device implantation. In the group submitted to the implantation of metal platforms there was greater coronary angulation change when compared to the group treated with BVS (41.6% vs. 14.9%; P

BACKGROUND: Drug-eluting stents (DES) have changed contemporary interventional cardiology practice, enabling the approach of increasingly more complex clinical and angiographic scenarios. The objective of this study was to demonstrate the changes observed in the last 10 years in the indication and practice of percutaneous coronary intervention (PCI) at a tertiary private hospital in the State of Sao Paulo. METHODS: DESIRE is a single-center prospective registry aiming at following the acute and late outcomes of consecutive patients treated by DES. RESULTS: From 2002 to 2011, 4,299 patients were included, with mean age of 64.3 ± 11.2 years, 23% were female and 30.5 were diabetic. The total number of lesions treated was 6,518 of which 61.5% were type B2/C. During the course of the study, DES were progressively more used, reaching a penetration of 88.4% in 2011. The complexity of PCIs has increased and in the past year 1.76 lesions per patient were treated with an average of 1.89 DES. The SYNTAX score increased from 12.3 ± 4.4 (2002-2006) to 15.7 ± 4.7 (2007-2011). Clinical follow-up was obtained in 98.2% of the patients, with a median of 5.2 years, and during this period target-lesion revascularization rate was 5%, myocardial infarction was 6.7% and cardiovascular death was 4.1%. Stent thrombosis was observed in 2.4% of the cases. CONCLUSIONS: Our results showed a marked increment in the complexity profile of patients treated in the last 10 years and at the same time confirm the long-term effectiveness of DES, despite the clinical and angiographic profile of patients.

INTRODUÇÃO: A via radial evoluiu na última década para uma abordagem versátil, mostrando resultados equivalentes ou superiores aos da via femoral. Avaliamos a incorporação da técnica radial em um centro formador de cardiologistas intervencionistas, e comparamos seus resultados aos da técnica femoral. MÉTODOS: Estudo observacional, unicêntrico, que incluiu pacientes consecutivos submetidos a intervenção coronária percutânea (ICP) entre 2007 e 2011. A via de acesso foi escolhida pelo residente, em conjunto com o intervencionista responsável pela ICP. Comparamos o desfecho combinado de óbito, infarto do miocárdio (IM) periprocedimento, acidente vascular cerebral isquêmico ou sangramentos maiores entre os dois grupos na fase hospitalar. RESULTADOS: Foram submetidos a ICP 5.545 pacientes, 29,8% pela via radial e 70,2% pela via femoral. A média de idade foi de 60,8 ± 11,7 anos, sendo 68,9% do sexo masculino e 29% portadores de síndromes coronárias agudas. Houve aumento do uso da via radial até 2010, e estabilização no ano subsequente (11,8% em 2008, 26,1% em 2009, 45,1% em 2010 e 42,6% em 2011). Os pacientes que utilizaram a via radial tinham perfil tanto clínico como angiográfico menos complexo. Não houve diferenças nos desfechos combinados (5% vs. 5,9%; P = 0,18), no óbito (0,1% vs. 0,8%; P = 0,71), no acidente vascular cerebral (0,06% vs. 0,03%; P = 0,53) ou no IM periprocedimento (4,5% vs. 3,8%; P = 0,27). Contudo, menor incidência de sangramentos maiores (0,4% vs. 1,3%; P < 0,01) e de complicações vasculares (0,5% vs. 2,2%; P < 0,01) foi observada com a via radial. CONCLUSÕES: Em nosso centro formador de cardiologistas intervencionistas, a ICP pela via radial foi rapidamente incorporada, e trouxe, para pacientes selecionados, resultados equivalentes aos da via femoral, com redução dos índices de sangramentos maiores e de complicações vasculares. BACKGROUND: The radial artery access has evolved into a flexible approach in the last decade, showing similar or superior results when compared to the femoral approach. We assessed the incorporation of the radial artery access in a training center for interventional cardiologists and compared the results to those of the femoral artery access. METHODS: Observational, single-center study, including consecutive patients undergoing percutaneous coronary intervention (PCI) between 2007 and 2011. The access route was chosen by the resident along with the interventionist responsible for PCI. We compared the composite endpoint of death, periprocedural myocardial infarction (MI), ischemic stroke or major bleeding between the two groups during hospitalization. RESULTS: Among 5,545 patients undergoing PCI, 29.8% used the radial approach and 70.2 used the femoral approach. Mean age was 60.8 ± 11.7 years, 68.9% were males and 29% had acute coronary syndromes. There was an increase in the use of the radial approach until 2010 and stabilization in the subsequent year (11.8% in 2008, 26.2% in 2009, 45.1% in 2010 and 42.6% in 2011). Patients using the radial approach had a less complex clinical and angiographic profile. There were no differences in the composite endpoint (5% vs. 5.9%; P = 0.18), death (0.1% vs. 0.8%; P = 0.71), stroke (0.06% vs. 0.03%; P = 0.53) or periprocedural MI (4.5% vs. 3.8%; P = 0.27). However, there was a lower incidence of major bleeding events (0.4% vs. 1.3%; P < 0.01) and vascular complications (0.5% vs. 2.2%; P < 0.01) with the radial approach. CONCLUSIONS: At our interventional cardiology training center, PCI through the radial approach was quickly incorporated and provided, for selected patients, outcomes similar to those of the femoral approach, with decrease of major bleeding and vascular complication rates.

INTRODUÇÃO: A trombose de stent é a oclusão súbita de uma artéria tratada com stent em decorrência da formação de trombos. Nosso objetivo foi identificar variáveis associadas à trombose definitiva de stent (TS) em stents não-farmacológicos e avaliar a evolução dos pacientes que apresentaram esse evento. MÉTODOS: Foram analisados pacientes tratados consecutivamente entre dezembro de 2007 e agosto de 2012. Aqueles com TS foram comparados ao grupo sem TS quanto às características clínicas e angiográficas, e evoluções inicial e tardia. RESULTADOS: De um total de 6.495 intervenções coronárias percutâneas (ICPs), foram observados 36 (0,55%) casos de TS, sendo em 18 (50%) precoce, em 14 (38,9%) tardia e em 4 (11,1%) muito tardia. Pacientes com TS mostraram ser mais jovens, com maior prevalência de insuficiência renal crônica e síndrome coronária aguda. TS ocorrereu mais frequentemente em lesões de bifurcação (11% vs. 4%; P = 0,03) ou lesões com presença de trombo visível à angiografia (55,5% vs. 2,8%; P < 0,01). Todos os pacientes foram submetidos a ICP de emergência, sendo observados, na fase intra-hospitalar, infarto do miocárdio (IM) e óbito em 33,3% e 16,6%, respectivamente. O tempo médio de seguimento foi de 30,2 ± 16,3 meses e a descontinuação precoce da terapia antiplaquetária dupla foi verificada em 6 dos 36 casos de TS (16,7%). Na evolução tardia observou-se revascularização do vaso-alvo em 33,3%, IM em 20% e nenhum óbito adicional. CONCLUSÕES: A TS mostrou ser evento com elevada mortalidade hospitalar e alta morbidade tardia. A ocorrência desse evento foi associada a características clínicas e angiográficas de maior complexidade e a menor aderência à terapêutica antiagregante dupla.