Impact of stent diameter on clinical outcomes following percutaneous coronary intervention with thirdgeneration drug-eluting stents: results from inspirion and latitude trials

INTRODUCTION: In patients treated with bare metal stents and earlygeneration drug-eluting stents (DES) smaller stent diameter (SD) has been associated with worse long-term outcomes after percutaneous coronary intervention (PCI). Data on the impact of small SD on outcomes after PCI with third generation DES is scarce. OBJECTIVE: The aim of this study was to evaluate the impact of SD on clinical outcomes, using a third generation sirolimus-eluting coronary stent with thin struts and abluminal biodegradable polymer. METHODS: Consecutive patients treated with Inspiron® (Scitech, Brazil) in native coronary arteries lesions between June 2017 and January 2022 were included, in a total of 25 Brazilian centers. Patients were grouped according to SD: 3.50mm. One-year event rates were estimated using the Kaplan-Meier method and adjusted hazard ratios were generated using Cox regression analysis. The primary endpoint was a composite of major adverse cardiovascular events (MACE) defined by the composite of cardiovascular death, myocardial infarction (MI) or target-lesion revascularization (TLR) at 12 months. RESULTS: Of the 2,803 patients who underwent PCI with Inspiron®, 24,5% (n = 688) had SD ≤2.50 mm, 45.0% (n = 1,263) had SD 2.75-3.00mm and 30,4% (n = 852) had SD >3.50 mm. At 1 year, MACE rates were 3.1%, 2.1% and 1.3%, respectively, with increasing SD (p = 0.054). Death due to CV causes at 12 months rates decreased with increasing SD (2.9%, 1.8% and 0.8%, respectively [p < 0.009]) whereas rates of MI related study device at 12 months across SD groups were comparable (0.0%, 0.5%, and 0.1%, respectively [p = 0.086]). After multivariate stepwise Cox regression, smaller SD remained associated with higher rates of MACE (HR 0.46, 95%CI of 0.241-0.890; p=0.022). As seen in Figure 1, the risk of MACE is significantly increased in the first 30 days and remain higher up to 12 months among individuals with mean vessel diameter <2.50mm. CONCLUSIONS: In a large cohort of patients undergoing PCI with third generation DES MACE rates were low, but still higher among patients with smaller SD, mainly drive by higher CV deaths at 12 months. Further research into the optimal treatment strategy of small coronary arteries is still warranted.

Bioresorbable polymer Sirolimus-Eluting stent in native coronary artery stenosis: results of the prospective, multicenter inspirion and latitude trials

INTRODUCTION: Inspiron® (Scitech, Brazil) is a 3rd generation drug eluting stent designed to create a fast and homogeneous endothelialization, possibly improving clinical outcomes. OBJECTIVES: The aim of this study was to evaluate the safety and efficacy of a sirolimus-eluting coronary stent, composed of a metallic chromium-cobalt platform with thin struts (75 µm), which releases sirolimus from a bioresorbable polymer applied only to the abluminal surface, in a real-world scenario, as a post-marketing clinical follow-up evaluation. METHODS: We pooled patient-level databases derived from the INSPIRION and LATITUDE prospective trials. Between June 2017 and January 2022, a total of 25 Brazilian centers included 2,803 patients that underwent percutaneous coronary intervention (PCI) in native coronary arteries lesions with Inspiron® (Scitech, Brazil) stent implantation. Exclusion criteria included target lesion located in saphenous vein or arterial graft, and use of coronary stent other than Inspiron® in the index procedure. The primary endpoint was a composite outcome of major adverse cardiovascular events (MACE) defined by the composite of cardiovascular death, myocardial infarction (MI) or target-lesion revascularization (TLR) at 12 months. The secondary outcomes included all-cause death, cardiovascular death, any MI, TLR, target-vessel revascularization (TVR), and probable and definite stent thrombosis at 12 months. RESULTS: The mean age was 62.0 ± 10.8 years, 36.5% had diabetes (12.7% on insulin), 17.6% had previous PCI and 54.9% presented with an acute coronary syndrome (ACS). At a median follow-up of 410 days, MACE occurred in 58 (2.1%) patients, all-cause death in 102 (3.6%), MI in 14 (0.5%), and target vessel revascularization in 2 (0.1%) patients. Definite or probable stent thrombosis occurred in 20 (0.7%) patients. CONCLUSIONS: The 1-year MACE rate, as well as the individual endpoint components, were low and consistent with previous results available for 3rd generation drug eluting stent. The result of this study demonstrates the safety and efficacy of this stent in a real-world population.

Ioxaglate versus IoDixanol for the prevention of contrast-induced nephropathy: the IDPC trial

BACKGROUND. Despite the potential benefits of percutaneous procedures for the assessment and treatment of coronary artery disease, these interventions require the use of iodine contrast, which might lead to contrast-induced nephropathy (CIN) and increased risk of dialysis and major adverse cardiac events (MACE). Aims. We sought to compare two different iodine contrasts (low vs. iso-osmolar) for the prevention of CIN among high-risk patients. METHODS. This is a single-center, randomized (1:1) trial comparing consecutive patients at high risk for CIN referred to percutaneous coronary diagnostic and/or therapeutic procedures with low (ioxaglate) vs iso-osmolarity (iodixanol) iodine contrast. High risk was defined by the presence of at least one of the following conditions: age >70 years, diabetes mellitus, non-dialytic chronic kidney disease, chronic heart failure, cardiogenic shock, and acute coronary syndrome (ACS). The primary endpoint was the occurrence of CIN, defined as a >25% relative increase and/or >0.5 mg/dL absolute increase in creatinine (Cr) levels compared with baseline between the 2nd and 5th day after contrast media administration. RESULTS. A total of 2268 patients were enrolled. Mean age was 67 years. Diabetes mellitus (53%), non-dialytic chronic kidney disease (31%), and ACS (39%) were highly prevalent. The mean volume of contrast media was 89 ml ± 48.6. CIN occurred in 15% of all patients, with no significant difference regarding the type of contrast used (iso = 15.2% vs low = 15.1%, P>.99). Differences were not observed in specific subgroups such as diabetics, elderly, and ACS patients. At 30-day follow-up, 13 patients in the iso-osmolarity group and 11 in low-osmolarity group required dialysis (P=.8). There were 37 (3.3%) deaths in the iso-osmolarity cohort vs 29 (2.6%) in the low-osmolarity group (P=.4). CONCLUSION. Among patients at high risk for CIN, the incidence of this complication was 15%, and independent of the use of low- or iso-osmolar contrast.

Serial assessment of coronary artery healing of a biodegradable polymer drug-eluting stent at 1, 2, and 3 months by optical coherence tomography (OCT)­the REPAIR trial

BACKGROUND: Although first-generation drug-eluting stent (DES) devices have effectively achieved their main goal of reducing restenosis, their safety has been limited by suboptimal polymer biocompatibility, delayed stent endothelialization, and local drug toxicity, which ultimately prompted the development of new-generation DES options carrying biocompatible or even biodegradable polymers. Aims. We sought to assess the vessel-healing pattern of the novel sirolimus-eluting Inspiron DES (Scitech Medical) using serial optical coherence tomography (OCT) and assuming the hypothesis that this thin-strut (75-µm), biodegradable-polymer DES promotes a faster healing, with very early strut coverage. METHODS. This is a prospective, multicenter, open-label, single-arm study enrolling 68 patients who underwent percutaneous coronary intervention guided by OCT. These patients were consecutively assigned into 3 groups. The first group had its OCT imaging follow-up performed at 3 months, the second group at 2 months, and the third group at 1 month. RESULTS: Mean age was 59.5 years, 70.6% were male, 41.2% had type 2 diabetes, and 29.4% presented with acute coronary syndrome. A total of 72 lesions were treated and 1.06 stents were implanted per patient. OCT assessment of the stents at 1, 2, and 3 months showed a strut coverage of 90.41%, 93.96%, and 97.21%, respectively (P=.04). CONCLUSION: The Inspiron DES showed an early strut healing pattern, with >90% of the struts covered by neointima within the first month and with almost all struts covered by the third month.

Independent clinical and echocardiographic predictors of restenosis after percutaneous mitral balloon commissurotomy in a large, consecutive cohort followed for 24 years

OBJECTIVES: to enlighten preprocedural risk factors of mitral valve restenosis in a large, single-center cohort of patients submitted to percutaneous mitral balloon commissurotomy (PMBC) for the treatment of mitral stenosis (MS) secondary to rheumatic heart disease. METHODS: this is a database analysis of a single-center, high-volume tertiary institution involving all consecutive PMBC procedures performed in the mitral valve (MV). Restenosis was diagnosed when MV area was <1.5 cm2 and/or loss of 50% or more of the immediate procedural result aligned with the return/worsened symptoms of heart failure. The primary endpoint was to determine the preprocedural independent predictors of restenosis after PMBC. Results: among a total of 1921 PMBC procedures, 1794 consecutive patients without previous intervention were treated between 1987 and 2010. Throughout 24 years of follow-up, MV restenosis was observed in 483 cases (26%). Mean age was 36 years and most (87%) were female. Median follow-up duration was 9.03 years (interquartile range, 0.33-23.38). Restenosis population, however, presented a significantly lower age at the procedure time as well as a higher Wilkins-Block score. At multivariate analysis, independent preprocedure predictors of restenosis were left atrium diameter (hazard risk [HR], 1.03; 95% confidence interval [CI], 1.02-1.05; P<.04), preprocedure maximum gradient (HR, 1.02; 95% CI, 1.00-1.03; P=.04), and higher Wilkins-Block score (>8) (HR, 1.38; 95% CI, 1.14-1.67; P<.01). CONCLUSIONS: at long-term follow-up, MV restenosis was observed in a quarter of the population undergoing PMBC. Preprocedure echocardiographic findings, including left atrial diameter, maximum MV gradient, and Wilkins-Block score were found to be the only independent predictors.

Analysis of 108 flexible bronchoscopies for the removal of foreign bodies from the airways

ABSTRACT Objective To describe the clinical, bronchoscopic, diagnostic, and therapeutic aspects between children and adults. Methods This retrospective study compared the clinical and bronchoscopic characteristics of adults and children who underwent bronchoscopy for suspected foreign body aspiration. Data on sex, outpatient or emergency origin, bronchoscopy results, characteristics of the aspirated foreign body, and complications were analyzed. Results In total, 108 patients were included in the analysis, with foreign body aspiration diagnosed in 69% of patients (30 children and 44 adults). In 91% of patients, there was a clinical history suggestive of aspiration. The mean age of the adults was 65.89 (±19.75) years, and that of the children was 2.28 (±1.78) years. Most of the children were under 3 years of age (80%), while adults were mostly 70 years of age or older (54.5%). Emergency care was more common among children than adults. The most common foreign bodies found in both age groups were organic bodies, primarily seeds. The most frequent locations of foreign bodies were the lobar bronchi in adults and the main bronchi in children. Flexible bronchoscopy is the primary method for diagnosis and treatment. Transient hypoxemia occurred particularly frequently in children (5%). Conclusion Foreign body aspiration, particularly that involving seeds, is more common in the extremes of age. A clinical history suggestive of aspiration is crucial in determining the need for bronchoscopy, which should be performed as early as possible. Flexible bronchoscopy is an effective and safe diagnostic technique.

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

BACKGROUND: Mitral valve stenosis (MVS) is one of the most common structural heart diseases in developing countries, primarily due to rheumatic disease. Percutaneous mitral balloon valvuloplasty (PMBV) has been, since its introduction in 1984, the preferred option of treatment for such disease. However, restenosis is presented 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 procedure. The objective of this study was to enlight risk factors of mitral valvular restenosis in a significant number of patients submitted to percutaneous mitral balloon commissurotomy for the treatment of mitral stenosis (MS), particularly when secondary to rheumatic heart disease. METHODS: This study reports the vast experience of a single center high volume tertiary institution where 1.794 consecutive patients were treated with PMBC between 1987 and 2011. The primary endpoint was to determine the independent predictors of this untoward event, defined as loss of over 50% of the original increase in maximum valve area (MVA) or MVA< 1.5 cm2. RESULTS: Mitral valve restenosis was observed in 26% of the cases (n=483). Mean population age was 36 years old, with most patients being female (87%). Mean follow up duration was 4.8 years. At multivariate analysis independent pre-procedural predictors of restenosis were: left atrial diameter (HR: 1.03, 95% ci: 1.01-1.04, p<0.01), pre procedure maximum gradient (HR: 1.01, 95% ci: 1.00-1.03, p=0.02) and higher wilkins scores (HR: 1.37, 95% ci: 1.13-1.66, p<0.01). CONCLUSION: In the very long term follow-up, mitral valve restenosis was observed in a quarter of the population undergoing PMBC. Preprocedure echocardiographic findings, including left atrial diameter, maximum valve gradient and high Wilkins scores were found to be the only independent predictors of this deleterious event.

Long-term follow-up in patients with rheumatic mitral stenosis and severe pulmonary artery hypertension submitted to percutaneous mitral balloon commissurotomy

BACKGROUND: Percutaneous balloon mitral commissurotomy (PMBC) is an attractive therapeutic approach in patients with mitral stenosis. The aim of this study was to assess the immediate and long-term clinical, echocardiographic and haemodynamic outcomes of PMBC in patients with severe pulmonary hypertension (PH). METHODS: Among all procedures (in more than two decades of experience), PMBC was performed from 1987 until 2011 at a single-center in 147 patients who had significant PH defined as baseline pulmonary artery mean pressure (PAMP) (systolic pulmonary pressure > 75 mmHg). All-cause mortality, need for mitral valve replacement (MVR) or new PMBC, and valve restenosis were evaluated during follow-up yearly. RESULTS: Mean age was 33.8 ± 12.8 years and 83.6% (123 patients) were women. Primary success was achieved in 89.8% of the patients (132 patients). Mitral valve area (MVA) increased from 0.83 ± 0.17 cm2 to 2.03± 0.35 cm2 (p<0.001), and at 20-years, mitral valve area was 1.46± 0.34 cm2 (p=0.235). Systolic pulmonary artery pressure decreased from 87.0 ± 6.0 mmHg to 60.0 ± 0.9 mmHg (p<0.001) The rates of all-cause mortality, need for MVR, new PMV, and valve restenosis were 0.67%, 20.0%, 8.78% and 30.4%, respectively, in long-term follow- up (mean 15.6 ± 4.9 years). CONCLUSIONS: PMBC is a safe and effective technique for the treatment of patients with mitral stenosis and PH. A significant decrease in pulmonary pressure was observed after commissurotomy. Although there was a gradual decrease of MVA at long-term follow-up, most patients remained asymptomatic and without major adverse events.

Immediate and long-term predictor score of success after percutaneous mitral balloon commissurotomy

BACKGROUND: Percutaneous mitral balloon commissurotomy (PMBC) remains the preferred treatment for patients with severe symptomatic rheumatic mitral stenosis (MS) and suitable anatomy. The objective of this study was to propose a new score for the prediction of immediate and late success. METHODS. This is a retrospective, single-center, single-arm registry encompassing all 1915 consecutive patients with rheumatic mitral stenosis recruited and referred to PMBC between August 3rd 1987 and July 19th 2010. All data were previously collected and recorded in a dataset. Clinical status was determined according to the New York Heart Association (NYHA) classification. Long-term outcome was a composite of incidence of major adverse cardiac events (cardiovascular death, new PMBC or mitral valve repair surgery) up to 24 years of clinical follow-up (from 1988 until December 3rd, 2011), including cardiovascular death, need for new PMBC, or mitral valve replacement surgery. RESULTS. Mean patient age was 36.8 ± 12.9 years, most (86.4%) were female, and Wilkins score was between 9-11 in 49.1% of patients. In the multivariate analysis, the predictors of immediate success were age (odds ratio [OR], 0.98; 95% confidence interval [CI], 0.96-0.99; p=0.01), left atrium size (OR, 0.96; 95% CI, 0.93-0.99; p=0.01), mean pre-procedure mitral gradient (OR, 0.93; 95% CI, 0.89-0.96; p<0.001), intermediate Wilkins score 9-11 (OR, 0.62; 95% CI, 0.40- 0.94; p=0.02), and high Wilkins score ≥12 (OR, 0.35; 95% CI, 0.16-0.76; p<0.01). For prediction of late events, age (hazard ratio [HR], 0.98; 95% CI, 0.97-0.98; p<0.001), New York Heart Association class III-IV (HR, 1.50; 95% CI, 1.18-1.92; p<0.001), left atrium size (HR, 1.02; 95% CI, 1.02-0.04; p<0.01), and high Wilkins score ≥12 (HR, 2.02; 95% CI, 1.30-3.15; p<0.01) were significant. Two nomograms were developed using significant predictors from the model (one for immediate results and another for long-term results). CONCLUSIONS: In this large population, not only the Wilkins score, but also clinical and hemodynamic features, seem to be relevant in predicting immediate and late success for patients with rheumatic MS who underwent PMBC.

Left main bifurcation lesion: the importance to determine the real complexity for decision making

Clinical Case • 63 years-old, african-american • Risk factors for CAD: • DM type 2 • Smoker (25 packs-year) • CKD (KDIGO STAGE 4 ­ CKD-EPI 27ml/min/m²) • Past medical Hx: • NSTEMI (2018), underwent PCI with DES in mid LAD • Current presentation: typical chest pain for last 2 weeks; burning episode led to ER where patient was diagnosed with NSTEMI

Intervenção coronária percutânea no tronco da coronária esquerda não protegido na rotina da prática diária: incidência, resultados imediatos e seguimento muito tardio / Percutaneous coronary intervention in the unprotected left main coronary artery in the routine of daily practice: incidence, immediate results and very late follow-up

INTRODUÇÃO: A intervenção coronária percutânea (ICP) no tronco da coronária esquerda (TCE) não protegido tem sido extensamente estudada nos últimos anos. Com o avanço tecnológico e técnico, e baseada nas evidências científicas mais recentes, tal procedimento é atualmente indicada como uma alternativa terapêutica segura e eficaz (e até mesmo preferencial) em casos selecionados. OBJETIVOS: Reportar a incidência de ICP no TCE não protegido na prática diária em um centro terciário de referência de alto volume. Descrever o perfil clínico e os dados do procedimento, assim como a evolução clínica imediata e tardia. MÉTODOS: A partir do banco de dados do Serviço de Hemodinâmica contendo 74.795 procedimentos percutâneos coronários diagnósticos e terapêuticos realizados entre 2008 e 2021, foram identificados 325 procedimentos de ICP realizadas no TCE não protegido com stent farmacológico, representando 1,9% do total de ICPs realizadas no período. Os dados do seguimento clínico tardio foram obtidos por meio de revisão de prontuário médico, consulta presencial ou contato telefônico. RESULTADOS: A média das idades era 69.0 ± 14.2 anos, 43% eram do sexo feminino, 29% tinham diabetes, 26% infarto prévio, 25% insuficiência renal crônica e 11% ICP prévia. Em relação a apresentação clínica, 30% apresentaram-se com síndrome coronária aguda, sendo 26% sem supra ST e 4% (n=13) com supra ST (4/13 com choque cardiogênico). A doença multiarterial estava presente em 61% do casos, e a localização da estenose (média da estenose do diâmetro = 66,9 ± 15%) no TCE foi encontrada em 32% no óstio, 26% no corpo e 42% na bifurcação. A via de acesso radial foi utilizada em 35% dos casos e o cateter-guia 6F em 74%. O diâmetro e extensão nominais do stent eram 3,55 ± 0,38 mm e 18,8 ± 9,5 mm, respectivamente. Pós dilatação com balão foi realizada em 93% dos casos e sucesso angiográfico foi obtido em 99,2%. Durante a fase intra-hospitalar ocorreram 5 óbitos, sendo 3 em pacientes com apresentação de choque cardiogênico; logo, 0,6% de mortalidade em pacientes sem choque. No seguimento muito tardio (média de 3,8 anos), a taxa de nova revascularização da lesão alvo foi 4,4%, e a mortalidade cardíaca foi 9,8%. CONCLUSÕES: A ICP no TCE (não protegido) na rotina da prática diária foi 1,9%, e incluiu pacientes com elevado perfil de risco. Menos da metade das lesões envolviam a bifurcação do TCE, e o implante do stent foi otimizado com pós dilatação com balão na grande maioria dos casos. O sucesso do procedimento foi elevado e as taxas de eventos adversos nas fases imediata e muito tardia foram relativamente baixas e comparáveis com as evidências mais recentes.

Perfil clínico, dados do procedimento e achados angiográficos de pacientes submetidos à exame diagnóstico de cateterismo cardíaco esquerdo e cineangiocoronariografia em um centro de referência terciário de grande volume / Clinical profile, procedural data, and angiographic findings of patients undergoing diagnostic examination for left heart catheterization and coronary angiography at a high-volume tertiary referral center

INTRODUÇÃO: O estudo angiográfico invasivo permanece como o exame diagnóstico padrão-ouro para a determinação e quantificação da gravidade e extensão da doença arterial coronária (DAC) obstrutiva. No geral, a maioria das indicações para realização do exame na atualidade inclui procedimentos eletivos em pacientes com suspeita de DAC obstrutiva significativa e pacientes com quadro clínica agudo ou recente de síndrome coronária aguda (SCA). OBJETIVO Determinar o perfil clínico, os dados do procedimento e os achados angiográficos em termos de gravidade e extensão da DAC em pacientes submetidos à exame diagóstico de cateterismo cardíaco esquerdo e cineangiocoronariografia em um centro de referência terciário de grande volume na prática diária. MÉTODOS: Entre 2007 e 2021, foram realizados cerca de 80.572 exames diagnósticos de cateterismo cardíaco esquerdo mais cineangiocoronariografia na rotina da prática diária em um centro de referência terciário de grande volume. Os dados demográficos basais, perfil de risco, apresentação clínica e achados angiográficos foram obtidos a partir do banco de dados dedicado do Serviço de Cardiologia Invasiva da instituição, cujo preenchimento é atrelado a elaboração e liberação do laudo do exame. RESULTADOS: A média das idades era 68,2±11,7 anos e 61,2% eram do sexo masculino. Em relação aos fatores de risco para DAC, 29,5% tinham diabetes (4,6% insulino dependente), 69,9% hipertensão arterial sistêmica, 53,9% dislipidemia, 23,9% infarto agudo do miocárdio prévio, 10,2% intervenção coronária percutânea prévia, 1,7% acidente vascular encefálico prévio, 2,4% doença vascular periférica (diagnosticada previamente), 1,8% com insuficiência cardíaca descompensada e 18,5% insuficiência renal crônica. Tabagismo atual e histórico foram encontrados em 12,7% e 21,3%, respectivamente. O diagnóstico prévio de doença valvar associada foi encontrado em 4,2% e a média do índice de massa corpórea era de 27,7±5,9 kg/m2. No geral, a apresentação clínica de SCA (fase aguda ou recente) foi encontrada em um 40% dos casos. Em termos de procedimento, a via de acesso radial foi utilizada em cerca de um terço dos casos, introdutores 5-Fr. e 6-Fr foram utilizados em 24,8 e 74,8%, respectivamente, e a média de volume total de contraste foi de 64,5±29,9 mL. Sobre os achados angiográficos, o padrão de dominância foi direita em 80%, esquerda em 8,5% e co-dominância em 11,5%. A ventriculografia esquerda foi realizada em 96% dos casos e observou-se algum grau de disfunção em 41,7%. Cerca de 60% dos casos evidenciaram a presença de DAC obstrutiva significativa (>50%), sendo 24% uniarterial, 18% biarterial e 18% triarterial ou tronco da coronária esquerda. CONCLUSÕES: Nesta análise, observa-se um elevado perfil de risco incluindo múltiplas comorbidades e apresentação clínica aguda em grande proporção. Ademais, a maioria dos pacientes apresentou DAC significativa.

Stent dedicado liberador de sirolimus para o tratamento de lesões de bifurcação coronária: resultados de 9 meses com análise de imagem multimodal e seguimento clínico tardio de 2 anos / Dedicated sirolimus-eluting stent for the treatment of coronary bifurcation lesions: 9-month results with multimodal image analysis and 2-year late clinical follow-up

INTRODUÇÃO: As bifurcações coronárias apresentam anatomia singular devido a geometria com diferentes diâmetros em cada segmento do vaso (proximal e ramos distais) e ao formato cônico da parte central (carina) que conecta o segmento proximal com os ramos distais. Os stents dedicados para bifurcação buscam falicitar a intervenção coronária percutânea (ICP) nessas lesões, minimizando os riscos de comprometimento do ramo lateral (RL), e melhorar os resultados clínicos imediatos e tardios. O stent farmacológico liberador de sirolimus BiOSS LIM (Balton, Varsóvia, Polônia) apresenta uma plataforma dedicada para bifurcações com um desenho composto por duas partes (proximal e distal, com diâmetro proximal maior que o distal) conectadas por dois elos localizados na região central do dispositivo que permite melhor adequação do stent à geometria da bifurcação assim como maior abertura e melhor acesso ao RL. OBJETIVO: Reportar o desempenho e a eficácia tardia por meio de imagem multimodal do stent dedicado BiOSS LIM no tratamento de lesões de bifurcação coronária. MÉTODOS: Um total de 35 pacientes (36 lesões de novo excluindo tronco da coronária esquerda) foram prospectivamente incluídos em um centro único e submetidos à ICP com o stent BiOSS LIM com abordagem provisional. Re-estudo invasivo foi realizado aos 9 meses em todos os pacientes e incluiu análises com métodos de imagem invasivos ­ ultrassom intracoronário (USIC) e tomografia de coerência óptica (OCT). Seguimento clínico foi realizado até 24 meses. RESULTADOS: A média das idades era 59,0±7,2 anos, 26% tinham diabetes, 29% tinham histórico de infarto do miocárdio (IM), e 46% apresentaram-se com síndrome coronária aguda recente (<30dias). A maioria das lesões era localizada na artéria coronária descendente anterior (69%), sendo classificadas como bifurcação verdadeira (Medina 1-1-1, 1-0-1, 0-1-1) em 42%. O stent BiOSS LIM foi implantado com sucesso em todos os casos, e um stent adicional foi implantado no RL em 25%. A pós-dilatação pela técnica POT ("proximal optimization technique") e o "kissing-balloon" final foram realizados em apenas 36% e 58%, respectivamente; não se observou comprometimento persistente do RL ao final do procedimento. Na fase intra-hospitalar, 01 paciente apresentou IM periprocedimento. No seguimento até 24 meses, 03 pacientes foram submetidos a revascularização da lesão alvo, sendo que não foram reportados eventos adversos adicionais. A Tabela apresenta os resultados dos métodos de imagem. CONCLUSÕES: O stent dedicado BiOSS LIM demonstrou elevada taxa de sucesso no tratamento de lesões de bifurcação coronária com abordagem técnica provisional e eficácia tardia na prevenção de hiperplasia neointimal nos diferentes segmentos anatômicos da bifurcação. No seguimento clínico muito tardio, observou-se segurança sustentada e taxa relativamente baixa de recorrências.

Reparação tecidual em pacientes submetidos à intervenção coronária percutânea com stent eluidor de sirolimus e polímero bioabsorvível: avaliação seriada através da tomografia de coerência óptica (ESTUDO REPAIR) / Tissue repair in patients undergoing percutaneous coronary intervention with sirolimus-eluting stent and bioabsorbable polymer: serial evaluation using optical coherence tomography (REPAIR STUDY)

INTRODUÇÃO: Os stents farmacológicos de novas gerações passaram por aprimoramentos para melhorar seu perfil de cicatrização, visando melhorar a segurança da intervenção coronária percutânea (ICP) relacionada à trombose de stents. Estes dispositivos passaram a ter hastes mais finas, polímeros mais biocompatíveis e mudanças nas doses e cinética de liberação dos fármacos. O stent Inspiron® compreende uma plataforma metálica de Cromo-Cobalto com hastes finas (75 mm), coberta em sua face abluminal por polímero bioabsorvível (PLLA + PLGA) e que libera baixa dose de sirolimus (80% da dose em 30 dias). OBJETIVO: Documentar o padrão de cobertura tecidual das hastes do stent Inspiron® através da avaliação seriada com tomografia de coerência óptica (TCO). Nossa hipótese é que stents com hastes finas e com polímeros bioabsorvíveis apresentam cobertura tecidual rápida e homogênea. MÉTODOS: Estudo prospectivo, multicêntrico que recrutou pacientes tratados com o stent Inspiron®, divididos em 3 grupos. O primeiro grupo realizou reestudo com TCO após 3 meses, o segundo após 2 meses e o terceiro após 1 mês. O desfecho primário foi a comparação entre o percentual de hastes cobertas pela neoíntima nos diferentes tempos pré-determinados. As análises foram realizadas em um corelab independente, cego em relação ao tempo em que o reestudo foi realizado. RESULTADOS: Foram tratadas 72 lesões em 68 pacientes. A média de idade foi de 59,5 anos, sendo 41,2% diabéticos e 29,4% com síndrome coronária aguda. Em relação ao desfecho primário, 90,41 ± 8,8% das hastes estavam cobertas após 1 mês, 93,96 ± 8,73% após 2 meses e 97,21 ± 3,03% após 3 meses (p = 0,042). A espessura da hiperplasia neointimal foi de 60 mm no 1º mês, 90 mm no 2º mês e 120 mm no 3º mês, demonstrando que a cicatrização ocorreu de forma homogênea e controlada nos primeiros 3 meses enquanto a média de obstrução pela hiperplasia neointimal foi de 4,45%, 6,95% e 10,11% e a área de hiperplasia neointimal foi de 0,54 mm2, 0,85 mm2 e 1,16mm2 após 1, 2 e 3 meses respectivamente (figura 1). CONCLUSÃO: O stent Inspiron® apresenta ótimo padrão de cicatrização precoce, com > 90% das hastes cobertas por tecido neointimal no primeiro mês e com praticamente todas as hastes cobertas no terceiro mês. Estes dados servirão como base para formulação de ensaios clínicos randomizados para avaliar a eficácia e segurança da ICP em pacientes submetidos ao implante de stents de nova geração e tempo de dupla antiagregação abreviado.

Abordagem contemporânea de lesões de bifurcação coronária tratadas na rotina de um serviço de referência de cardiologia invasiva / Contemporary approach to coronary bifurcation lesions routinely treated at an invasive cardiology referral service

INTRODUÇÃO: O tratamento percutâneo de lesões de bifurcação coronária pode ser tecnicamente desafiador e associar-se à complicações relacionadas ao comprometimento do ramo lateral (RL). De maneira geral, a estratégia provisional, com implante primário de stent no vaso principal (VP), é a técnica mais utilizada; entretanto, a melhor abordagem em lesões mais complexas, permanece em debate. OBJETIVO: Reportar a incidência e a abordagem técnica de lesões de bifurcação coronária submetidas à intervenção coronária percutânea (ICP) na prática diária contemporânea em um serviço de referência terciário. MÉTODOS: Foi realizado um levantamento de dados de procedimentos de ICP realizados durante 01 ano, entre 01/03/2021 até 28/02/2022, sendo identificados os pacientes com lesão de bifurcação coronária com RL ≥2.0mm tratados com stents farmacológicos. A complexidade das lesões foi determinada pela classificação de Medina, sendo a lesão de bifurcação verdadeira considerada na vigência de comprometimento significativo (estenose >50%) dos 02 ramos. Sucesso angiográfico foi definido como: fluxo TIMI 3, lesão residual <50% e ausência de dissecção no VP e no RL ao final do procedimento. RESULTADOS: Dentre os 1898 procedimentos de ICP realizados no período, 327 (17,2%) envolviam bifurcações, sendo 60% (197/327) classificadas como lesões de bifurcação verdadeiras. No geral, os pacientes com bifurcações apresentaram-se com síndrome coronária aguda em 70% dos casos e 74% tinham comprometimento multiarterial. A via de acesso radial foi utilizada em 73% e métodos de imagem invasivos guiaram a ICP em 15%. A tabela exibe os dados angiográficos e técnicos. O sucesso angiográfico nos 02 ramos foi obtido em 93%, devido principalmente a comprometimento persistente do RL em 21 casos (6%). CONCLUSÕES: As lesões de bifurcação coronária representaram 17% dos procedimentos de ICP realizados na prática contemporânea, sendo que a maioria apresentava elevada complexidade anatômica. Mesmo assim, a estratégia preferencial foi o implante de apenas 01 stent no VP. Dos casos tratados com 02 stents, a técnica DK-crush foi a mais utilizada. O POT e o kissing-balloon final foram realizados na maioria dos casos e o comprometimento persistente do RL foi evidenciado em apenas 6% das lesões tratadas.

Preditores independentes de reestenose da valva mitral após valvoplastia mitral percutânea por balão em uma grande coorte consecutiva com seguimento clínico por mais de duas décadas / Independent predictors of mitral valve restenosis after percutaneous balloon mitral valvuloplasty in a large consecutive cohort with clinical follow-up for more than two decades

INTRODUÇÃO: A valvoplastia mitral percutânea com balão (VMPB), sempre que tecnicamente viável, é a opção de tratamento preferencial para a estenose mitral, particularmente aquelas secundárias à doença cardíaca reumática. No entanto, a reestenose valvar mitral pode se desenvolver em um número significativo de pacientes submetidos a esse procedimento, com fatores de risco ainda pouco claros para tal ocorrência. OBJETIVOS: O objetivo deste estudo foi elucidar os fatores de risco da reestenose valvar mitral em um número significativo de pacientes submetidos à comissurotomia mitral percutânea por balão para tratamento da estenose mitral (EM), principalmente quando secundária à cardiopatia reumática. MÉTODOS: Trata-se de uma análise de centro único de uma coorte grande e consecutiva de pacientes tratados com VMP entre 1987 e 2010, que desenvolveram reestenose. O desfecho primário foi determinar os preditores independentes desse evento, definido como perda de mais de 50% do aumento original na área valvar mitral máxima (AVM) ou AVM menor que 1,5cm2. RESULTADOS: Um total de 1.794 pacientes consecutivos submetidos a VMP em um único centro, instituição terciária de alto volume, foram incluídos neste registro. Reestenose da valva mitral foi observada em 26% dos casos (n=483). A média de idade da população foi de 36 anos, com a maioria dos pacientes sendo do sexo feminino (87%). A duração média do acompanhamento foi de 4,8 anos. Na análise multivariada, os preditores independentes de reestenose foram: diâmetro atrial esquerdo [RR (risco relativo): 1,03; IC (intervalo de confiança) 95%: 1,01-1,04; p <0,01]; gradiente máximo pré-procedimento (RR: 1,01; IC 95%: 1,00-1,03; p=0,02) e Wilkinsscore > 8 (RR: 1,37; IC 95%: 1,13-1,66; p<0,01). CONCLUSÕES: No seguimento em longo prazo, a reestenose da valva mitral foi observada em até 25% da população submetida à VMP. Os achados ecocardiográficos pré-procedimento, incluindo o diâmetro do átrio esquerdo, o gradiente valvar máximo e o escore de Wilkins, foram os únicos preditores independentes desse desfecho desfavorável.

Seguimento a longo prazo de valvuloplastia mitral percutânea em pacientes com estenose reumática mitral e hipertensão arterial pulmonar grave / Long-term follow-up of percutaneous mitral valvuloplasty in patients with rheumatic mitral stenosis and severe pulmonary arterial hypertension

INTRODUÇÃO: A hipertensão arterial pulmonar pode ser um fator de complicação em pacientes com estenose valvar reumática e que serão submetidos a valvuloplastia mitral percutânea por balão (VMPB), sendo esta uma abordagem terapêutica atraente em pacientes com estenose mitral de origem reumática. OBJETIVOS: O objetivo deste estudo foi avaliar os resultados imediatos e de longo prazo em pacientes com hipertensão pulmonar (HAP) submetidos à VMPB e estenose mitral (EM) reumática. MÉTODOS: Entre os 1.794 pacientes consecutivos, de 1987 a 2010, a VMP foi realizada em um único centro em 147 pacientes que tinham HAP significativa definida como pressão arterial média basal (pressão pulmonar sistólica > 75mmhg). Mortalidade por todas as causas, necessidade de substituição valvar mitral ou nova VMP e reestenose valvar foram avaliados durante o acompanhamento anual. RESULTADOS: A média de idade foi de 33,8±12,8 anos e 83,6% (123 pacientes) eram mulheres. O sucesso foi alcançado em 89,8% dos pacientes (132 pacientes). A área valvar mitral (AVM) aumentou de 0,83±0,17cm2 para 2,03±0,35cm2 (p <0,001) e, aos 20 anos, a área valvar mitral foi de 1,46±0,34cm2 (p=0,235). A pressão sistólica da artéria pulmonar diminuiu de 87,0±6,0mmHg para 60,0±0,9mmHg (p <0,001) As taxas de mortalidade por todas as causas, necessidade de substituição da valva mitral, nova VMP e reestenose valvar foram de 0,67%, 20,0%, 8,78% e 30,4%, respectivamente, em seguimento a longo prazo (média de 15,6±4,9 anos). CONCLUSÕES: Observou-se que houve diminuição significativa da pressão arterial pulmonar após o procedimento e a VMPB é considerada segura e eficaz em pacientes com EM reumática. Embora tenha havido uma diminuição gradual da AVM a longo prazo, a maioria dos pacientes permaneceu assintomática e sem grandes eventos adversos.

Randomized clinical trial on prevention of radial occlusion after transradial access using Nitroglycerin: PATENS trial

OBJECTIVES: The aim of this study was to evaluate whether administration of nitroglycerin at the beginning or end of a transradial approach (TRA) procedure would preserve radial patency. BACKGROUND: The TRA is becoming the preferred vascular access route in coronary interventions. Radial artery occlusion (RAO) is the most frequent complication. Routine vasodilator treatment aims to reduce spasm and possibly prevent RAO. METHODS: The authors designed a prospective, multicenter, randomized, double-blind, 2-by-2 factorial, placebo-controlled trial encompassing patients undergoing the TRA. Patients were randomized to either 500 µg nitroglycerin or placebo; each arm was also subrandomized to early (upon sheath insertion) or late (right before sheath removal) nitroglycerin administration to evaluate the superiority of nitroglycerin in the prevention of RAO with 24 hours on Doppler ultrasound. RESULTS: A total of 2,040 patients were enrolled. RAO occurred in 49 patients (2.4%). Fifteen of these patients (30.6%) showed reestablishment of flow at 30 days. Nitroglycerin, compared with placebo, did not reduce the risk for RAO at either of the 2 time points (early, 2.5% vs 2.3% [P = 0.66]; late, 2.3% vs 2.5% [P = 0.66]). By multivariable analysis, the presence of spasm (OR: 3.53; 95% CI: 1.87-6.65; P < 0.001) and access achieved with more than 1 puncture attempt (OR: 2.58; 95% CI: 1.43-4.66; P = 0.002) were independent predictors of RAO. Conclusions: The routine use of nitroglycerin was not associated with a reduction in the rate of RAO, regardless of the time of administration (at the beginning or end of the TRA procedure).

Sleep endoscopy as a complementary diagnostic method for snoring and sleep apnea

ABSTRACT Obstructive sleep apnea is a disorder characterized by complete or incomplete and recurrent upper airway collapse induced by sleep. Several diagnostic methods for obstructive sleep apnea are used, but only sleep endoscopy allows an endoscopic assessment of pharyngeal collapse during sedation. It is essential to carry out sleep endoscopy following a systematic institutional protocol, in preestablished stages, to ensure better reproducibility and reliability of the results found. Sleep endoscopy has few limitations and is a safe test, with a low risk of complications.

Novel prognostic score for immediate and late success after percutaneous mitral balloon commissurotomy in patients with mitral stenosis

INTRODUCTION: Percutaneous mitral balloon commissurotomy (PMBC) remains the preferred treatment for patients with severe symptomatic rheumatic mitral stenosis (MS) and suitable anatomy. OBJECTIVE: The objective of this study was to propose a new score for the prediction of immediate and late success. METHODS: This is a retrospective, single-center, single-arm registry encompassing all 1915 consecutive patients with rheumatic mitral stenosis recruited and referred to PMBC between August 3rd 1987 and July 19th 2010. All data were previously collected and recorded in a dataset. Clinical status was determined according to the New York Heart Association (NYHA) classification. Long-term outcome was a composite of incidence of major adverse cardiac events (cardiovascular death, new PMBC or mitral valve repair surgery) up to 24 years of clinical follow-up (from 1988 until December 3rd, 2011), including cardiovascular death, need for new PMBC, or mitral valve replacement surgery. RESULTS: Mean patient age was 36.8 ± 12.9 years, most (86.4%) were female, and Wilkins score was between 9-11 in 49.1% of patients. In the multivariate analysis, the predictors of immediate success were age (odds ratio [OR], 0.98; 95% confidence interval [CI], 0.96-0.99; p = 0.01), left atrium size (OR, 0.96; 95% CI, 0.93-0.99; p = 0.01), mean pre-procedure mitral gradient (OR, 0.93; 95% CI, 0.89-0.96; p < 0.001), intermediate Wilkins score 9-11 (OR, 0.62; 95% CI, 0.40-0.94; p = 0.02), and high Wilkins score ≥12 (OR, 0.35; 95% CI, 0.16-0.76; p < 0.01). For prediction of late events, age (hazard ratio [HR], 0.98; 95% CI, 0.97-0.98; p < 0.001), New York Heart Association class III-IV (HR, 1.50; 95% CI, 1.18-1.92; p < 0.001), left atrium size (HR, 1.02; 95% CI, 1.02-0.04; p < 0.01), and high Wilkins score ≥12 (HR, 2.02; 95% CI, 1.30-3.15; p < 0.01) were significant. Two nomograms were developed using significant predictors from the model (one for immediate results and another for long-term results). CONCLUSIONS: In this large population, not only the Wilkins score, but also clinical and hemodynamic features, seem to be relevant in predicting immediate and late success for patients with rheumatic MS who underwent PMBC.