Independent clinical and echocardiographic predictors of restenosis after percutaneous mitral balloon commissurotomy followed for 24 years

BACKGROUND Mitral valve stenosis is one of the most common structural heart diseases in developing countries and is primarily due to rheumatic disease. Percutaneous mitral balloon valvuloplasty (PMBV) has been, since its introduction in 1984, the preferred treat ment. However, restenosis presents with an approximate incidence of 20%. Echocardiographic scoring of the mitral apparatus has been the main tool used to indicate and foresee the possible result of the pro cedure. The objective of this study was to examine risk mitral valvular restenosis in a significant number of patients submit ted to percutaneous mitral balloon commissurotomy (PMBC) for the treatment of mitral valve stenosis, particularly when secondary to rheumatic heart disease. METHODS This study reports the vast experience of a single high volume tertiary institution where 1,794 consecutive patients were treated with PMBC from 1987 to 2011. The primary end point was to determine the independent predictors of this untoward event, defined as loss of more than 50% of the original increase in maximum valve area (MVA) or MVA < 0.01), preprocedure maximum gradient (HR: 1.01; 95% CI: 1.00-1.03; P » 0.02), and higher Wilkins score (HR: 1.37; 95% CI: 1.13-1.66; P < 0.01). RESULTS Mitral valve restenosis was observed in 26% of the cases (n » 483). Mean population age was 36 years, with most patients being female (87%). Mean follow-up duration was 4.8 years. At multivariate analysis, independent preprocedural predictors of restenosis were left atrial diameter (HR: 1.03; 95% CI: 1.01-1.04; P < 0.01), preprocedure maximum gradient (HR: 1.01; 95% CI: 1.00-1.03; P » 0.02), and higher Wilkins score (HR: 1.37; 95% CI: 1.13-1.66; P < 0.01). CONCLUSION In the very-long-term follow-up, mitral valve reste nosis was observed in one-fourth of the population undergoing PMBC. Preprocedure echocardiographic findings for left atrial diameter, maximum valve gradient, and high Wilkins score were found to be the only independent predictors of this deleterious event.

Cardiovascular Risk Stratification for Patients Treated With Drug-Eluting Stents: Development and Validation of the DESIRE Score.

BACKGROUND: 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. METHODS: 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). RESULTS: 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 fraction <40%; 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. CONCLUSION: 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.

Very Long Term Follow-Up After Percutaneous Balloon Mitral Valvuloplasty

OBJECTIVES: The aim of this study was to assess very long term outcomes after successful percutaneous balloon mitral valvuloplasty (PBMV).BACKGROUND: PBMV remains the preferred treatment for patients with severe symptomatic rheumatic mitral stenosis and suitable anatomy.METHODS: 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.RESULTS: 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 to0.99; 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 lmortality, need for mitral valve surgery, or repeat PBMV were 0.6% (95% CI: 0.3% to 1.2%), 8.3% (95% CI: 7.0% to9.9%), 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 to0.98; p»0.028), and mitral valve area#1.75 cm2after the procedure (hazard ratio: 1.67; 95% CI: 1.28 to 2.11;p»0.028) were independent predictors of the primary endpoint. CONCLUSIONS: In 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.(J Am Coll Cardiol Intv 2018;11:1945­52) © 2018 by the American College of Cardiology Foundation.

Preditores de sucesso imediato e seguimento de muito longo prazo após valvoplastia mitral percutânea com balão em pacientes com estenose mitral reumática / Predictors of immediate success and very long-term follow-up after percutaneous mitral balloon valvuloplasty in patients with rheumatic mitral stenosis

INTRODUÇÃO: A valvoplastia mitral percutânea por balão (VMP) ainda permanece como tratamento preferencial para pacientes com estenose mitral reumática sintomática grave e com anatomia favorável. Este estudo tem o objetivo de analisar os resultados a longo prazo após VMP. MÉTODOS: Trata-se de uma análise retrospectiva unicêntrica de todos os 1.582 pacientes com estenose mitral grave que foram submetidos VMP com sucesso entre 1987 e 2011. O desfecho primário foi o combinado de mortalidade por todas as causas, necessidade de cirurgia valvar mitral ou necessidade de repetição de VMP até o seguimento de 23 anos. RESULTADOS: Entre os 1.582 pacientes consecutivos submetidos a VMP, o sucesso imediato foi alcançado em 90,9% (1.438 pacientes). Os preditores independentes de sucesso agudo incluíram tamanho do átrio esquerdo (OR: 0,96; IC 95%: 0,93-0,99; p = 0,045), escore de Wilkins ≤ 8 (OR: 1,66; IC95%: 0,48-0,93; p = 0,02) e idade (OR: 0,97, IC 95%: 0,96-0,99, p = 0,006). A teste c-estatístico calculada para prever o sucesso foi de 0,68. Não houve diferença significativa com relação às taxas de sucesso ao longo dos anos. Quando dividida em tercis com base na experiência do operador, uma maior taxa de sucesso foi observada no segundo tercil quando comparado com os outros dois grupos (32,0% vs. 46,5% vs. 21,5%, p = 0,046). O seguimento a longo prazo (média de 15,6 ± 4,9 anos) foi obtido em 79,1% dos casos de sucesso. A incidência do desfecho primário foi de 19,1% (IC 95%: 17,0-21,1). A mortalidade global, necessidade de cirurgia valvar mitral ou a repetição de VMP foi de 0,6% (IC 95%: 0,3-1,2), 8,3% (IC 95%: 7,0-9,9) e 10,0% (IC 95%: 8,5-11,7), respectivamente. Um total de 93,1% de todos os 1.252 pacientes após VMP com sucesso teve uma melhora na classe funcional NYHA após o primeiro ano do procedimento. Destes, apenas 13,0% desenvolveram a NYHA III-IV durante todo o período de acompanhamento (23 anos)...(AU)

Very Long Term Follow-Up After Percutaneous Balloon Mitral Valvuloplasty.

OBJECTIVES: The aim of this study was to assess very long term outcomes after successful percutaneous balloon mitral valvuloplasty (PBMV). BACKGROUND: PBMV remains the preferred treatment for patients with severe symptomatic rheumatic mitral stenosis and suitable anatomy. METHODS: 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. RESULTS: 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 cm2 after the procedure (hazard ratio: 1.67; 95% CI: 1.28 to 2.11; p = 0.028) were independent predictors of the primary endpoint. CONCLUSIONS: In 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.

Progression and Prognosis of Paravalvular Regurgitation After Transcatheter Aortic Valve Implantation / Evolução e Prognóstico da Regurgitação Paravalvar Após Implante de Valva Aórtica Transcateter

Abstract 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)

Progression and Prognosis of Paravalvular Regurgitation After Transcatheter Aortic Valve Implantation.

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).

Impact of PCI Appropriateness in the Long-Term Outcomes of Consecutive Patients Treated With Second-Generation Drug-Eluting Stents.

BACKGROUND: 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). METHODS: 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. RESULTS: 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. CONCLUSIONS: In this contemporary cohort of patients treated with second-generation DES implantation, AUC did not impact 3-year clinical follow-up.

Prognostic value of renal function in patients with aortic stenosis treated with transcatheter aortic valve replacement

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 < 0.001) and 1-year mortality (44.2% vs. 4.7%, P < 0.001) were higher in group 1. After multivariable-adjusted models, the only independent predictor for AKI after TAVR was baseline GFR (HR: 1.37, 95% CI: 1.08-1.77, P = 0.01). The independent risk factors for 1-year mortality were AKI (HR: 15.66, 95% CI: 6.07-44.63, P < 0.001), COPD (HR: 3.14, 95% CI: 1.05-9.40, P = 0.04) and aortic regurgitation grade postprocedure ≥ 2 (P = 0.05) also after multivariate analysis...

Prospective comparison between three TAVR devices: ACURATE neo vs. CoreValve vs. SAPIEN XT. A single heart team experience in patients with severe aortic stenosis

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...

Impact of PCI appropriateness in the long-term outcomes of consecutive patients treated with second-generation drug-eluting stents

BACKGROUND: 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). METHODS: 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. RESULTS: 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...

Long-term clinical follow-up of patients undergoing percutaneous alcohol septal reduction for symptomatic obstructive hypertrophic cardiomyopathy

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 < 0.001) and septum thickness (from 23.9 ± 0.6 mm to 12.9 ± 1.0 mm, P < 0.001). Only one patient (1.7%) required permanent pacemaker immediately after ASA. During follow-up, one patient had a repeated ASA...

Desfechos clínicos precoces e tardios após tratamento de enxertos de veia safena com stents MGuardTM vs. stents farmacológicos / Early and late clinical outcomes after saphenous vein graft treatment with MGuardTM stents vs. drug-eluting stents

Introdução: O stent MGuard™, revestido por malha polimérica microscópica, tem a finalidade de reduzir a embolização distal de fragmentos durante a intervenção coronária percutânea (ICP) em enxertos de veia safena (EVS). Avaliamos os desfechos clínicos precoces e tardios de pacientes submetidos à ICP de EVS com stents MGuard™ vs. stents farmacológicos (SF). Métodos: Estudo observacional, retrospectivo, realizado em dois centros terciários, envolvendo uma coorte de pacientes com lesões em EVS, tratados de forma eletiva ou de emergência com stents MGuard™ ou SF. Resultados: Foram incluídos 271 pacientes, sendo 220 tratados com SF. O Grupo MGuard™ apresentou maior proporção de mulheres (25,5% vs. 10,5%; p=0,01), com média de idades de 65,0 ± 13,9 anos vs. 69,0 ± 9,6 anos (p = 0,06). O Grupo SF utilizou com maior frequência filtro de proteção distal (5,8% vs. 10,0%; p = 0,001). Sucesso angiográfico 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 à menor incidência de infarto periprocedimento. Entretanto, a taxa de ECAM em 1 ano foi maior no grupo MGuard™ (14,3% vs. 4,4%; p = 0,01) à custa de maior taxa de revascularização da lesão alvo (7,1% vs. 1,3%; p = 0,048). Conclusões: A utilização de stent MGuard™ resultou em redução de eventos na fase hospitalar, porém, no longo prazo, os SF foram superiores em reduzir desfechos maiores, sobretudo a necessidade de revascularização da lesão alvo

Background: The MGuard™ 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™ stents vs. drug­eluting 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™ stents or DES. Results: A total of 271 patients were included, of whom 220 were treated with DES. The MGuard™ 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™ 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™ 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™ 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

Fatores predisponentes para revascularização angiográfica incompleta em pacientes com intervenção coronária percutânea de múltiplos vasos / Predisposing factors for incomplete angiographic revascularization in patients with multivessel percutaneous coronary intervention

A revascularização miocárdica anatômica completa está associada a um melhor controle dossintomas 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. Métodos: Estudo de coorte envolvendo 1.049 pacientes revascularizados de forma prospectiva e consecutivapor 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%).Resultados: A 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.Conclusões: A 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 nosresultados clínicos da fase hospitalar...

Complete anatomical myocardial revascularization is associated with better anginacontrol and lower rates of cardiac events. However, in a significant number of patients treated bypercutaneous coronary intervention (PCI), complete revascularization is not achieved. Thus, the aimof this study was to evaluate factors associated with incomplete myocardial revascularization (IMR) in multivessel PCI patients. Methods: This 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%). Results: IMR 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. Conclusions: IMR 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...

Implante transcateter valve-in-valve para disfunção de biopróteses cirúrgicas aórticas / Transcatheter valve-in-valve implantation for surgical aortic bioprosthesis dysfunction

Introdução: Estudos recentes têm demonstrado a eficácia do implante transcateter valve-in-valve para otratamento de disfunção de biopróteses em pacientes de alto risco cirúrgico. Apresentamos nossa experiênciainicial com o implante valve-in-valve.Métodos: Caracterizamos o perfil clínico, ecocardiográfico e do procedimento, e reportamos os resultados de médio prazo de pacientes com disfunção de bioprótese submetidos a implante valve-in-valve em posição aórtica. Resultados: Incluímos sete pacientes do sexo masculino, com idade de 72,6 ± 10,0 anos. O escore STS foi 9,6± 10,5%, e o EuroSCORE logístico foi 22,7 ± 14,7%. Três pacientes apresentavam dupla disfunção; dois tinham insuficiência; e dois exibiam estenose isolada. A via transfemoral foi utilizada em seis casos, e a transapical, em um caso. Os dispositivos implantados incluíram as próteses Sapien XT (n = 5) e CoreValve (n = 2). O sucesso do procedimento foi obtido em seis (85,7%) casos. Após o procedimento, o gradiente médio reduziu-se de 38,2 ± 9,6mmHg para 20,9 ± 5,9 mmHg, e a área valvar elevou-se de 1,2 ± 0,4 cm2 para 1,5 ± 0,5 cm2. Ao final de 1 ano, nãoocorreram óbitos e nem outros desfechos adversos significativos; 80% dos pacientes encontravam-se em classefuncional NYHA I/II. Os gradientes transvalvares e a área valvar permaneceram inalterados nesse período. Conclusões: O procedimento valve-in-valve foi eficaz na maioria dos pacientes de alto risco cirúrgico comdisfunção de bioprótese. Quando realizado em pacientes bem selecionados, resulta em desfechos clínicos e hemodinâmicos satisfatórios.

Background: Recent studies have demonstrated the efficacy of the transcatheter valve-in-valveimplantation for the treatment of bioprosthesis dysfunction in high-risk surgical patients. This study presents the initial experience with valve-in-valve implantation. Methods: Clinical, echocardiographic, and procedural profiles were characterized, and the mid-term results of patients with surgical bioprosthesis dysfunction submitted to valve-in-valve implantation in theaortic position were reported.Results: Seven male patients were included, aged 72.6 ± 10.0 years. The STS score was 9,6 ± 10,5%, andthe logistic EuroSCORE was 22.7 ± 14.7%. Three patients had combined aortic bioprosthesis failure; two had isolated regurgitation; and two had isolated stenosis. The transfemoral access was used in six cases, and the transapical access in one case. Implanted devices included Sapien XT (n = 5) and CoreValve (n = 2) prostheses. Procedural success was achieved in six (85.7%) cases. After the procedure, the mean gradient decreased from 38.2 ± 9.6 mmHg to 20.9 ± 5.9 mmHg, and the valve area increased from 1.2 ±0.4 cm2 to 1.5 ± 0.5 cm2. After 1 year, there were no deaths and no other significant adverse outcomes; 80% of patients were in NYHA functional class I/II. The transvalvular gradients and valve area remained unchanged in this period.

A Randomized Trial of Creatine-kinase Leak After Rosuvastatin in Elective Percutaneous Coronary Intervention (CLEAR-PCI).

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).

Desfechos clínicos tardios de pacientes diabéticos tratados com stents farmacológicos eluidores de sirolimus ou everolimus: uma análise do registro DESIRE / Late clinical outcomes of diabetic patients treated with sirolimus or everolimus drug-eluting stents: an analysis of the DESIRE registry

Stents 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 eluidoresde everolimus (SEE; segunda geração).Métodos: Entre 2007 e 2014, 798 diabéticos foram tratados com SES (n = 414) ou SEE (n = 384) e incluídosnesta 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. Resultados: A 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 ± 20,4 mm vs. 37,7 ± 22,2 mm; 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).Conclusões: Nesta experiência unicêntrica, o uso de SEE em diabéticos mostrou-se com menor mortalidadecardíaca e trombose da endoprótese. Esse benefício se fez mais evidente no seguimento mais tardio...

Despite 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). Methods: Between 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 andthe groups were compared regarding the occurrence of major adverse cardiac events (MACE) and stent thrombosis. Results: In 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 ± 22.2 mm; 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)...

First-in-man assessment of the InSeal VCD, a novel closure device for large puncture accesses.

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.

First-in-man assessment of the InSeal VCD, a novel closure device for large puncture accesses

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.

Impacto da Curva de Aprendizado na Seleção de Pacientes e nos Resultados Clínicos do Implante por Cateter de Prótese Aórtica / Impact of Transcatheter Aortic Valve Implantation Learning Curve on Patient Selection and Clinical Outcomes

Introdução: O implante por cateter de prótese aórtica (TAVI, do inglês transcatheter aortic valve implantation) constitui tratamento alternativo para pacientes com estenose aórtica de alto risco cirúrgico ou inoperáveis. Para adquirir competência, o grupo multidisciplinar deve receber treinamento específico e acumular experiência na execução do TAVI. Contudo, sua curva de aprendizado não está bem estabelecida. Nosso objetivo foi analisar o impacto da curva de aprendizado na seleção de pacientes, nos aspectos técnicos e nos resultados clínicos do TAVI. Métodos: Estudo observacional e prospectivo dos primeiros 150 pacientes submetidos a TAVI por via femoral, entre janeiro de 2009 e dezembro de 2013 divididos em tercis (n = 50) de acordo com a data do procedimento. Os desfechos foram definidos conforme os critérios Valve Academic Research Consortium-2 (VARC-2). Resultados: A idade foi de 82,5 ± 6,7 anos, sendo 44% homens e 75% em classe NYHA III/IV. O EuroSCORE (24,2 ± 13% vs. 21,2 ± 10,8% vs. 23,4 ± 14,3%) e o STS Score (5,9 ± 2,9% vs. 6,7 ± 4,3% vs. 5,8 ± 3,1%) foram similares entre os grupos. Observou-se redução gradativa nos tempos do procedimento (107,2 ± 48,1 minutos vs. 90,3 ± 42,2 minutos vs. 76,6 ± 37,7 minutos; p < 0,01) e de fluoroscopia (31,3 ± 9,6 minutos vs. 25,4 ± 8,7 minutos vs. 17,2 ± 6,2 minutos; p = 0,01), e no ...

Background: Transcatheter aortic valve implantation (TAVI) is an alternative treatment for high-risk or inoperable patients with aortic stenosis. The multidisciplinary team must undergo specific training and accumulate experience to achieve optimal results. However, its learning curve is not well established. Our objective was to investigate the impact of learning curve on patient selection, technical aspects and clinical outcomes of TAVI. Methods: Observational, prospective analysis of the first 150 patients undergoing transfemoral TAVI between January 2009 and December 2013. Patients were divided into tertiles (n = 50), according to the procedure date. Outcomes were defined according to Valve Academic Research Consortium-2 (VARC-2) criteria. Results: Mean age was 82.5 ± 6.7 years, 44% were male and 75% were in NYHA class III/IV. EuroS-CORE (24.2 ± 13% vs. 21.2 ± 10.8% vs. 23.4 ± 14.3%) and STS Score (5.9 ± 2.9% vs. 6.7 ± 4.3% vs. 5.8 ± 3.1%) were similar between groups. A gradual decrease was observed in procedure times (107.2 ± 48.1 minutes vs. 90.3 ± 42.2 minutes vs. 76.6 ± 37.7 minutes; p < 0.01), fluoroscopy times (31.3 ± 9,6 minutes vs. 25.4 ± 8.7 minutes vs. 17.2 ± 6.2 minutes; p = 0.01) and contrast volume (145.5 ± 70.9 mL vs. 123.2 ± 87.8 mL vs. 101.1 ± 50 mL; p = 0.01). Mortality decreased gradually (20% vs. 10% vs. 4%; p = 0,047), and lower bleeding and moderate-to-severe aortic regurgitation were ...