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.

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.

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.

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.

Independent mitral valve predictors of restenosis after percutaneous mitral balloon commissurotomy in a large, consecutive cohort followed for more than two decades

AIMS: 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 AND RESULTS: 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. mitral valve restenosis was observed in 26% of the cases (n=483). average 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). CONCLUSIONS: 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 indepen dent 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

AIMS: 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 AND RESULTS: 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. 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<0.0001). 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.

Dissecção espontânea de artéria coronária: características demográficas e angiográficas do Registro Brasileiro Scalibur / Spontaneous coronary artery dissection: demographic and angiographic characteristics of the Scalibur Brazilian Registry

INTRODUÇÃO: A dissecção espontânea de artéria coronária (SCAD do inglês spontaneous coronary artery dissection) é uma causa não aterosclerótica de síndrome coronariana aguda que acomete preferencialmente mulheres jovens. De fisiopatologia ainda não completamente conhecida, pode manifestar-se sob a forma de infarto agudo do miocárdio com (IAMCSST) ou sem (IAMSSST) supradesnivelamento do segmento. A SCAD é a principal causa de infarto agudo do miocárdio no ciclo gravídico-puerperal. A descrição demográfica e angiográfica da SCAD de coorte brasileira é pouco explorada. OBJETIVO: Avaliar o perfil demográfico, angiográfico e os gatilhos de SCAD em uma população brasileira. MATERIAL E MÉTODOS: Estudo retrospectivo e prospectivo de pacientes com SCAD envolvendo 22 Hospitais no Brasil. Revisão de base de dados do REDcap no período de 2010-2021. RESULTADOS: Registraram-se 166 pacientes com SCAD, com idade média de 50,15 ± 10,56 anos (29 a 84 anos) com incidência prevalente no gênero feminino (85%). Os pacientes apresentavam nenhum ou poucos fatores de risco para doença arterial coronariana, incluindo hipertensão arterial (25%), história familiar de doença coronariana precoce (22%), dislipidemia mista (16%) e tabagismo ativo (16%). Seis por cento dos casos de SCAD ocorreram no ciclo gravídico puerperal. A maioria dos casos de SCAD manifestou-se como IAMSSST (47%), com IAMCSST (38%) e angina instável (12%) (Tabela). Entre os fatores desencadeantes, presentes em 57,8% dos casos, destacaram-se: estressor emocional (21,08%) e menopausa (18,07%). A displasia fibromuscular, não investigada sistematicamente, foi observada em poucos casos (4,21%), gestação (0,6%), puerpério (10,24%), estressor físico (5,42%), uso de terapia hormonal (3,60%) e doenças psiquiátricas (2,40%). A artéria descendente anterior foi o vaso mais acometido (57%), seguida pela coronária direita (14,45%). Complicações graves mais frequentes foram choque cardiogênico (3,28%) e parada cardiorrespiratória (0,7%). CONCLUSÃO: Nesta grande coorte brasileira, a SCAD acometeu preferencialmente pacientes jovens e mulheres. A frequência de fatores de risco clássicos para doença arterial coronariana foi pouco comum, sendo o gatilho predominante o estressor emocional. Esta entidade deve ser considerada como diagnóstico diferencial na síndrome coronariana aguda, principalmente em mulheres jovens (< 50 anos).

Optical coherence tomography versus intravascular ultrasound and angiography to guide percutaneous coronary interventions: the iSIGHT Randomized Trial

BACKGROUND: Specific algorithms for use of optical coherence tomography (OCT) to guide percutaneous coronary intervention (PCI) are scarce. Also, the relative benefits of intravascular imaging guidance have not been tested against an optimized angiography-guided PCI strategy. In iSIGHT (Optical Coherence Tomography Versus Intravascular Ultrasound and Angiography to Guide Percutaneous Coronary Interventions), we aimed to investigate whether OCT-guided PCI achieves noninferior stent expansion compared with intravascular ultrasound (IVUS) guidance and if both imaging modalities lead to superior stent expansion compared with an optimized angiography-based strategy. METHODS: Patients ≥18 years old undergoing PCI for ≥1 lesion in native coronaries of 2.25 to 4.00 mm in diameter were randomized 1:1:1 to OCT-, IVUS-, or angiography-guided PCI. Predetermined guidance protocols were applied in all groups. An external elastic membrane­based protocol was used for stent sizing by OCT and IVUS. The primary end point was noninferiority of stent expansion (minimum stent area ≥90% of the average reference lumen area), measured by post-PCI OCT, in OCT-guided versus IVUS-guided PCI (noninferiority margin, 6.5%). RESULTS: One hundred fifty-one patients (156 lesions) were randomly allocated to OCT (51 lesions [32.7%]), IVUS (52 lesions [33.3%]), or angiography (53 lesions [34.0%]). Stent expansion with OCT guidance (98.01±16.14%) was noninferior to IVUS (91.69±15.75%; 1-sided lower 95% CI, 0.55 mm2; Pnon-inferiority<0.001) and superior to angiography (90.53±14.84%, P=0.041). IVUS and angiography obtained similar stent expansions (P=0.921). Stent edge dissection and periprocedural complication rates were not significantly different among the groups. CONCLUSIONS: Stent expansion with OCT guidance using a dedicated external elastic membrane­based sizing strategy was noninferior to that achieved with IVUS and superior to an optimized angiographic strategy.

Implantation of thin-strut sirolimus-eluting bioresorbable vascular scaffold in patients with de novo coronary artery lesions: 2-year clinical and 6-month imaging outcomes of the eRes-1 Extend Trial

BACKGROUND: The development of bioresorbable vascular scaffold (BRS) offers a new treatment strategy for coronary artery lesion by replacement of a permanent metallic scaffold with a temporary scaffold and eradicating a nidus for very late adverse events. The first-in-human MeRes-1 trial reported favorable safety and efficacy of thin-strut (100 mm) MeRes100 sirolimus-eluting BRS (Meril Life Sciences Pvt. Ltd., India) in patients with de novo coronary artery lesions. Hence, to reaffirm the outcomes of the MeRes-1 trial, the MeRes-1 Extend trial sought to evaluate the safety and efficacy of the MeRes100 BRS in diverse patient population in Europe, Brazil, South Africa, and Asia Pacific. METHODS: The MeRes-1 Extend was a multicenter, prospective, single-arm study of MeRes100 BRS in 64 patients from Spain, Macedonia, Brazil, South Africa, Malaysia, and Indonesia. The safety endpoint was major adverse cardiac events (MACE), which composed of cardiac death, myocardial infarction (MI), and ischemia-driven target lesion revascularization (ID-TLR). Quantitative coronary angiography and optical coherence tomography (OCT) imaging was performed at baseline and 6-month follow-up. RESULTS: Among 64 enrolled patients (mean age: 58.30 _ 9.02 years), 26.56% had diabetes mellitus and 68.75% patients presented with stable angina. Of 69 target lesions, 71.01% were classified as type B2/C; average lesion length was 14.37 _ 5.89 mm and mean reference vessel diameter was 3.03 _ 0.35 mm. Procedural and device success was achieved in 64 and 62 patients, respectively. MACE was reported in 1 patient (1.61%) at 24-month follow-up in the form of ID-TLR with absence of MI, cardiac death, or scaffold thrombosis. At 6-month angiographic follow-up in a subset of 32 patients, mean in-scaffold LLL was 0.18 _ 0.31 mm. OCT analysis (n » 21) reported 97.95 _ 3.69% strut coverage with mean scaffold area of 7.56 _ 1.79 mm2 and no evidence of strut malapposition. CONCLUSION: Based on 2-year clinical and 6-month imaging outcomes, the MeRes-1 Extend trial established favorable safety and efficacy of MeRes100 sirolimus-eluting BRS in patients with de novo coronary artery lesions. (AU)

Impacto do pré-tratamento com heparina de baixo peso molecular no grau de degeneração de enxertos de veia safena submetidas à intervenção coronária percutânea / Impact of low molecular weight heparin pretreatment on the degree of degeneration of saphenous vein grafts submitted to percutaneous coronary intervention

INTRODUÇÃO: enxertos de veia safena (VS), comumente utilizados em cirurgias de revascularização miocárdica, habitualmente cursam com aterosclerose e degeneração aceleradas. Apesar dos avanços técnicos e farmacologia adjunta, a intervenção coronária percutânea (ICP) de tais enxertos permanece um desafio, com altas taxas de complicações agudas (infarto peri-procedimento) e tardias (reestenose). No presente estudo, visamos avaliar o papel do pré-tratamento com heparina de baixo peso molecular (HBPM) no grau de degeneração do enxerto de VS antes da ICP. METODOLOGIA: Estudo unicêntrico e retrospectivo em que registros médicos e angiografias de todos os pacientes submetidos à ICP de enxertos de VS entre julho de 2008 e julho de 2018 foram revisados. Dados de pacientes submetidos à pré-tratamento com HBPM após a cinecoronariografia diagnóstica foram inseridos em banco de dados dedicado. As angiografias dos enxertos de VS antes e após o pré-tratamento com HBPM foram analisadas por operador experiente, cego ao momento em que a angiografia foi realizada, em programa validado de angiografia coronária quantitativa. Escore de degeneração, computando todas as áreas de ectasias, estenoses e trombos foi computado em cada período de avaliação. RESULTADOS: Dentre as 554 ICP em VS realizadas no período do estudo, 90 (16.2%) pacientes receberam pré-tratamento com HBPM. Destes, 67 pacientes, com 72 enxertos tratados, possuíam angiografias adequadas para análise. A maioria (75%) dos pacientes era masculina, 54% diabéticos e 57% tiveram síndrome coronariana aguda como apresentação inicial. O vaso-alvo de implante do enxerto mais comum foi a coronária direita (36,1%), e 80% das lesões localizavam-se no corpo dos enxertos. O tempo de pré-tratamento com HBPM foi de 5,6 dias. O comprimento médio analisado dos enxertos mediu 84,09 mm. Não houve diferença na presença de ectasias (12,48 vs 11,53mm) ou estenoses (21,73 vs 22,98mm), nem no escore de degeneração (1,22 vs 1,02) dos enxertos antes e depois do uso de HBPM. Trombo intraluminal foi visto inicialmente em 38 enxertos (52,7%). Pré-tratamento com HBPM reduziu significativamente a carga trombótica (12,56 mm vs. 6,07 mm, p<0,05), com redução em 21 (55.2%) enxertos e remissão completa em 7 (18.4%). Melhora do fluxo TIMI foi observada em 13 enxertos (fluxo TIMI pré: 2,7 vs. Pós: 2,86). (AU)

Efeito concertina em intervenção coronária percutânea: realmente benigno, ou maligno? / Concertine effect on percutaneous coronary intervention: really benign or malignant?

Um homem de 68 anos apresentou angina típica e teste ergométrico positivo. Ele foi encaminhado ao laboratório de cardiologia intervencionista e a cineangiocoronariografia mostrou reestenose intra-stent em terço médio de artéria coronária drieta e foi decidida a intervenção coronária percutânea com stent farmacológico (SF). O paciente tinha pressão arterial de 140/80 mmHg. Após o cruzamento da lesão, notou-se uma série de novas "pseudo" lesões (efeito de concertina) antes do segmento doente e a paciente queixou-se de dor torácica intensa, pressão arterial de 40/20 mmHg, frequência cardíaca de 40 bpm com necessidade de drogas vasoativas e supradesnivelamento do segmento ST de 5 mm apareceram. O SF foi rapidamente implantado e, apesar dos nitratos intracoronários, as pseudolesões só desapareceram apenas após a retirada do fio-guia. Um efeito de concertina é visto quando os vasos arteriais tortuosos são endireitados com um fio-guia rígido. A terapêutica preferida é remover tudo da artéria e restabelecer a geometria coronária. O paciente se recuperou, foi para a UTI e recebeu alta no dia seguinte. (AU)

Novo escore prognóstico preditor de sucesso imediato e tardio após valvuloplastia mitral percutânea / New predictive prognostic score for immediate and late success after percutaneous mitral valvuloplasty

INTRODUÇÃO: A valvuloplastia mitral percutânea por balão (VMP) continua sendo o tratamento preferencial para pacientes com estenose mitral (EM) reumática sintomática grave e com anatomia adequada. O objetivo deste estudo foi propor uma nova pontuação para predizer sucesso imediato e tardio. MÉTODOS: Trata-se de uma análise retrospectiva unicêntrica de todos os 1582 pacientes com estenose mitral grave submetidos à VMP de agosto de 1987 a julho de 2010 com valva nativa. O desfecho composto foi morte de origem cardiovascular, nova VMP ou cirurgia de reparo mitral até 24 anos de seguimento. RESULTADOS: A média de idade foi 36,8 ± 12,9 anos, a maioria do sexo feminino (86,4%), e o escore de Wilkins foi entre 9 e 11 (49,1%). Na análise multivariada, os preditores de sucesso imediato foram idade [OR (razão dos riscos): 0,98, IC (intervalo de confiança) 95%: 0,96-0,99, p = 0,01], tamanho do átrio esquerdo (OR: 0,96, IC95%: 0,93-0,99, p = 0,01) , gradiente mitral médio pré-procedimento do (OR: 0,93, IC95%: 0,89-0,96, p = 0,0001), Wilkins-score 9-11 (OR: 0,62, IC 95%: 0,40-0,94, p = 0,02) e Wilkins-score pontuação ≥ 12 (OR: 0,35, IC 95%: 0,16-0,76, p = 0,008). Para predição de eventos tardios, idade [RR (risco relativo): 0,98, IC 95%: 0,97-0,98, p = 0,0001], NYHA III-IV (RR: 1,50, IC 95%: 1,18-1,92, p = 0,0009), tamanho do átrio esquerdo (RR: 1,02; IC95%: 1,02-0,04; p = 0,003); Wilkins-score 9-11 (RR: 1,10; IC95%: 0,87-1,38; p = 0,40) e Wilkins-score ≥ 12 (RR: 2,02, IC 95%: 1,30-3,15, p = 0,001) foram significativos. Dois nomogramas foram desenvolvidos usando preditores significativos do modelo. Nós avaliamos a precisão preditiva do nomograma usando a curva ROC AUC e o nomograma foi calibrado. CONCLUSÕES: Nesta grande população, não apenas o escore estabelecido de Wilkins, mas também as características clínicas e hemodinâmicas, parecem ser relevantes na predição de sucesso imediato e tardio em pacientes com EM reumática submetidos à VMP. CONCLUSÕES: Nesta grande população, não apenas o escore estabelecido de Wilkins, mas também as características clínicas e hemodinâmicas, parecem ser relevantes na predição de sucesso imediato e tardio em pacientes com EM reumática submetidos à VMP. (AU)

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 (VMP), 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. 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 1,5 cm2. 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 Wilkins score maior que 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. (AU)

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 mitral rheumatic stenosis and severe pulmonary arterial hypertension

INTRODUÇÃO: O objetivo deste estudo foi avaliar os resultados imediatos e de longo prazo em pacientes com hipertensão pulmonar (HAP) submetidos à valvuloplastia mitral percutânea por balão (VMP) 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 > 75 mmhg). 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 ± 0,17 cm2 para 2,03 ± 0,35 cm2 (p <0,001) e, aos 20 anos, a área valvar mitral foi de 1,46 ± 0,34 cm2 (p = 0,235). A pressão sistólica da artéria pulmonar diminuiu de 87,0 ± 6,0 mmHg para 60,0 ± 0,9 mmHg (p <0,0001). 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 VMP 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. (AU)

Serial intravascular ultrasound evaluation of the DESolveTM novolimus-eluting bioresorbable coronary scaffold system

INTRODUCTION: Bioresorbable coronary scaffolds (BRS) have been developed to increase the late safety of coronary angioplasty by providing transitory coronary support and then being fully incorporated to the vessel wall. In the present trial, we sought to evaluate the performance and changes over time in the DESolveTM novolimus-eluting BRS using serial intravascular ultrasound (IVUS) in patients submitted to percutaneous coronary interventions. Methods: Single-center, prospective, non-randomized study involving 17 consecutive patients submitted to implantation of the DESolveTM scaffold and serial evaluated with IVUS at different time points (post procedure, 6 and 18 months). Primary endpoint included the variation in lumen, scaffold, and vessel diameter and area along the months. RESULTS: Angiographic success was achieved in all cases. Scaffold area and volume on IVUS were significantly greater at 6 months than at baseline (6.41 6 1.35 mm2 vs. 7.35 6 1.53 mm2, P < 0.002; and 101.19 6 20.9 mm3 vs. 118.51 6 26.6 mm 3, P 5 0.001). Late lumen loss was 0.22 6 0.30 mm at 6 months and 0.33 6 0.44 mm at 18 months. No major adverse cardiac events occurred. At late follow-up (18 months) the scaffold was not visualized by IVUS; therefore the evaluation was restricted to lumen and vessel at that time point. CONCLUSIONS: IVUS serial evaluation of the novel DESolve BRS showed an increase in the device dimensions between baseline and 6 months, with concomitant enlargement of lumen dimensions and effective suppression of neointimal proliferation. At 18 months, no footprint of the scaffold was detected and the initial lumen enlargement was sustained.