Final 36-Month Outcomes from the Multicenter DynamX Study Evaluating a Novel Thin-Strut Novolimus-Eluting Coronary Bioadaptor System and Supporting Preclinical Data.

Background: The DynamX Novolimus-Eluting Coronary Bioadaptor System ( DynamX ® Bioadaptor) has uncaging elements that disengage after the resorption of the polymer coating, aiming to restore vessel function in the treated segment and to avoid long-term adverse outcomes associated with the permanent caging of the coronary artery seen with conventional stenting. Methods: This prospective, multicenter, single-arm first-in-human study enrolled 50 patients in Belgium and Italy who were treated with the DynamX Bioadaptor. Eligible patients had de novo lesions in coronary arteries measuring between 2.5 and 3.5 mm in diameter and ≤ 24 mm in length. Clinical follow-up was performed up to 36 months. This analysis includes the intention-to-treat population and is based on data available. The preclinical studies include optical coherence tomography (OCT) analyses of 5 DynamX Bioadaptors implanted in 3 mini Yucatan pigs (at 3, 12 and 24 months), and assessment of smooth muscle cell gene expression profile in 8 pigs of which each was implanted with the DynamX Bioadaptor and the Xience drug-eluting stent. To assess the gene expression profile by quantitative real-time polymerase chain reaction, animals were sacrificed at 3, 6, 9 and 12 months. Results: Target lesion failure at 36 months was 8.7% (4/46), consisting of one clinically-driven target lesion revascularization and 3 cardiac deaths (all site-reported to be unrelated to the device or procedure). There were no additional target vessel revascularization and no definite or probable scaffold thrombosis. Preclinical data confirmed late lumen enlargement (from 7.02 ± 1.31 mm 2 at baseline to 8.46 ± 1.31 mm 2 at 24 months) and identified an increased expression of contractile genes around 9 months compared to a conventional drug-eluting stent. Conclusions: The DynamX Bioadaptor demonstrated very good 36-month clinical outcomes, highlighted by the absence of target-vessel myocardial infarction and definite or probable device thrombosis, and only one target lesion revascularization up to 36 months. These data are supported by preclinical studies that showed late lumen enlargement by OCT and an increased expression of contractile genes around 9 months compared to conventional drug-eluting stents, indicating faster vessel healing. Larger clinical studies are necessary to compare outcomes against contemporary drug-eluting stents. Clinical Trial Registration: https://clinicaltrials.gov/: NCT03429894.

Imaging and 2-year clinical outcomes of thin strut sirolimus-eluting bioresorbable vascular scaffold: The MeRes-1 extend trial.

OBJECTIVES: This study explores the safety and efficacy of thin strut MeRes100 sirolimus-eluting bioresorbable vascular scaffold (BRS) in patients with de novo coronary artery lesions. BACKGROUND: In interventional cardiology, the emergence of BRS technology is catalyzing the next paradigm shift. METHODS: The MeRes-1 Extend was a multicenter, prospective, single-arm, open-label study enrolling 64 patients in 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). The imaging efficacy endpoint was mean in-scaffold late lumen loss (LLL) evaluated by quantitative coronary angiography (QCA). Optical coherence tomography (OCT) imaging was performed at baseline and 6-month follow-up. RESULTS: A total of 69 target lesions were identified in 64 enrolled patients (mean age 58.30 ± 9.02 years). Of the treated lesions, 49 (71.01%) lesions were of type B2/C. Procedural and device success was achieved in 64 and 62 patients, respectively. At 2-year follow-up, MACE was reported in one patient (1.61%) in the form of ID-TLR. There was no case of MI, cardiac death or scaffold thrombosis through 2-year. In a subset of 32 patients, paired QCA showed mean in-scaffold LLL of 0.18 ± 0.31 mm at 6-month follow-up. In a subset of 21 patients, OCT revealed 97.95 ± 3.69% strut coverage with mean scaffold area of 7.56 ± 1.79 mm2 and no evidence of strut malapposition. CONCLUSIONS: The clinical and imaging outcomes of MeRes-1 Extend trial demonstrated favorable safety and efficacy of MeRes100 sirolimus-eluting BRS in patients with de novo coronary artery lesions.

Association between Clinical Risk Score (Heart, Grace and TIMI) and Angiographic Complexity in Acute Coronary Syndrome without ST Segment Elevation. / Associação entre Escores de Risco Clínico (HEART, GRACE e TIMI) e Complexidade Angiográfica na Síndrome Coronária Aguda sem Elevação do Segmento ST.

BACKGROUND: GRACE, TIMI and HEART scores have been previously validated to predict serious untoward events among patients with non-ST elevation acute coronary syndrome (Non-ST ACS). However, the ability of these scores to discriminate the angiographic complexity of coronary artery disease has not been clearly established. OBJECTIVES: We sought to evaluate the correlation between clinical scores (TIMI, GRACE and HEART) and the anatomical complexity assessed by SYNTAX score, among non-ST ACS patients undergoing cinecoronariography. METHODS: Transversal cohort encompassing patients with diagnosis of Non-ST ACS referred to invasive stratification in our single center, between July 2018 and February 2019. Association between the scores was established by the Pearson's linear correlation test while the accuracy of the clinical scores versus SYNTAX score was determined with the ROC curve. RESULTS: A total of 138 patients were enrolled. Median GRACE, TIMI and HEART scores were 97, 3 and 5, respectively, whereas the median SYNTAX was 8. There was a positive correlation between the SYNTAX and the HEART (ρ =0.29; p<0.01) and GRACE (ρ =0.18; p<0.01) scores, but the correlation with TIMI reached no statistical significance (ρ =0.15; p=0.08). The HEART score was also the one with the highest area under the curve to predict a SYNTAX ≥32 [HEART = 0.81 (IC95% 0.7-0.91). HEART> 4 presented 100% sensitivity, with 50% specificity; and GRACE> 139 showed 55% sensitivity and 97% specificity for high SYNTAX. CONCLUSION: The clinical scores presented a positive, although modest, association with the SYNTAX score. The combined use of HEART and GRACE offers good accuracy for detecting angiographic complexity.

FUNDAMENTOS: Os escores GRACE, TIMI e HEART foram validados para avaliar desfechos clínicos desfavoráveis no contexto da suspeita de síndrome coronária aguda sem elevação do segmento ST (SCASSST). No entanto, a associação entre os escores clínicos e a complexidade angiográfica ainda não está bem estabelecida. OBJETIVOS: Descrever as características clínicas de pacientes com SCASSST admitidos em internação hospitalar para estratificação invasiva, a fim de avaliar a associação entre os escores clínicos (TIMI, GRACE e HEART) e a complexidade angiográfica, através do escore SYNTAX. MÉTODOS: Estudo observacional incluindo pacientes com diagnóstico de SCA e admitidos no Instituto Dante Pazzanese de Cardiologia entre os meses de julho de 2018 e fevereiro de 2019. A associação entre os escores foi avaliada por correlações bivariadas e a sua acurácia pela área sob a curva (ASC) ROC. A significância estatística foi estabelecida em 5% (p < 0,05). RESULTADOS: Um total de 138 pacientes foram diagnosticados com SCASSST. As medianas do GRACE, TIMI e HEART foram de 97, 3 e 5, respectivamente. A mediana do SYNTAX foi de 8. Foram observadas correlações positivas do SYNTAX com o HEART (ρ = 0,29; p < 0,01) e o GRACE (ρ = 0,18; p < 0,03). Em contrapartida, a correlação com o TIMI não atingiu significância estatística (ρ = 0,15; p = 0,08). O HEART foi o escore com a maior ASC para predizer SYNTAX > 32 [HEART = 0,81] (IC 95% 0,7-0,91). HEART > 4 apresentou sensibilidade de 100%, com especificidade de 50%, e GRACE > 139 sensibilidade de 55% e especificidade de 97% para SYNTAX alto. CONCLUSÃO: Os escores clínicos de risco apresentam associação modesta ao escore SYNTAX. O uso combinado do HEART e do GRACE, entretanto, oferece acurácia favorável para a detecção de complexidade angiográfica.

The revascular active percutaneous interventional device for coronary total occlusions study.

BACKGROUND: Despite the well-documented benefit of recanalization of an occluded vessel in some symptomatic patients, attempt is only performed in a minority of them. Percutaneous coronary intervention (PCI) of CTO is associated with high incidence of complications and unsuccessful procedure, mainly due to inability to cross the lesion. We sought to evaluate the efficacy and safety of the novel RVT CTO Guidewire Device (RVT-GDW, ReVascular Therapeutics, Sunnyvale, CA) in this complex scenario. METHODS: The RAPID-CTO study is a non-randomized, single center, first-in-man evaluation of a new guidewire system for treatment of CTO. The RVT-GDW is a new device designed to provide enhanced penetration and positioning control for crossing CTO via: (1) an 0.014 "guidewire with a mechanically active distal end; (2) a handle attached proximally to the guidewire, with an adjustable torquer, and interfaced to (3) a non-disposable, battery-operated, control unit, that provides activation control and audio feedback during the CTO crossing procedure. Per protocol, the RVT-GDW device was only used after at least 5 min (fluoroscopy time) of attempt with commercially available conventional guidewires to cross the target lesion. RESULTS: A total of 16 patients (16 lesions) were treated with the RVT-GDW. Mean age was 56.25 years, 56.2% were men, and 25% diabetics. The average duration of occlusion was 4.7 +/- 2.1 months. The mean vessel reference diameter was 2.76 +/- 0.31 mm and the mean lesion length was 16.64 +/- 7.70 mm (range 4.37-35.0 mm). Thirteen patients (81.2%) had "tapered stump" morphology at the proximal end of the occlusion, and a side branch was involved in 12 (75.0%). All lesions had contralateral circulation; bridging collaterals were seen in three (18.7%). Procedural success was achieved in 10 lesions (62.5%), with an average procedural time of 111.43 +/- 35.76 min. There were no major adverse cardiac events at both in-hospital and 30-day clinical follow-up. CONCLUSIONS: The first-in-man RAPID-CTO study suggests that the novel RVT-GDW device is technically feasible, safe and effective in crossing chronically occluded coronary arteries. Larger studies are warranted.

Intravascular ultrasonic differences between aorto-ostial and shaft narrowing in saphenous veins used as aortocoronary bypass grafts.

Previous studies have reported differences in interventional complication rates that depend on saphenous vein graft (SVG) lesion location. However, little is known about morphologic differences between lesions in different SVG locations. We evaluated preintervention intravascular ultrasound (IVUS) images of 75 de novo SVG lesions (aorto-ostial, n = 15; shaft, n = 60) in 63 patients. IVUS data were measured at the minimal lumen area and at 2 proximal and 2 distal references. Positive remodeling was defined as a lesion site SVG area that was larger than the average of the 2 distal references. Shaft lesions more often contained soft plaque (60.0% vs 26.7%, p = 0.02). Minimal lumen areas were identical (4.5 +/- 2.9 vs 4.3 +/- 1.5 mm2, p = 0.3); however, plaque burden at the minimal lumen area was greater in shaft locations (79.3 +/- 9.4% vs 72.1 +/- 9.2%, p = 0.01). The frequency of positive remodeling in shaft versus aorto-ostial lesions was 70.2% versus 26.7% (p = 0.002). SVG shaft lesions have more soft plaque and larger plaque burdens and undergo positive remodeling more frequently than SVG aorto-ostial lesions. These IVUS differences may account for some of the location-specific differences in interventional complications.

Volumetric intravascular ultrasound assessment of neointimal hyperplasia and nonuniform stent strut distribution in sirolimus-eluting stent restenosis.

The neointimal hyperplasia (IH) distribution pattern of in-stent restenotic lesions after sirolimus-eluting stent (SES) implantation has not been well described. We identified 48 in-stent restenotic lesions (41 patients) after SES implantation and performed volumetric intravascular ultrasound analyses. Lumen area, stent area, and IH area at the minimal lumen area site were 2.7 +/- 1.0, 5.4 +/- 1.9, and 2.7 +/- 1.4 mm(2), respectively. IH area at the minimal lumen site was larger in the group with a stent area > or =5.0 mm(2) than the group with a stent area <5.0 mm(2) (3.7 +/- 1.3 vs 1.9 +/- 0.8 mm(2), p <0.001). There were fewer visualized stent struts in lesions with a minimum stent area > or =5.0 mm(2) at the minimum lumen site compared with those with a stent area <5.0 mm(2) (0.69 +/- 0.25 vs 0.83 +/- 0.16, p = 0.04). When we compared lesions in patients with diabetes mellitus with patients without diabetes, minimum lumen areas, percent IH at minimal lumen area, percent IH, and neointima-free stent length were identical. In conclusion, (1) lesions without SES underexpansion at the minimum lumen site had more IH and greater nonuniform stent strut distribution compared with restenotic SESs that were underexpanded, and (2) the IH response did not appear to be more aggressive in patients with diabetes mellitus than in those without diabetes mellitus.

Metallic Limus-Eluting Stents Abluminally Coated with Biodegradable Polymers: Angiographic and Clinical Comparison of a Novel Ultra-Thin Sirolimus Stent Versus Biolimus Stent in the DESTINY Randomized Trial.

AIMS: To evaluate the outcomes of patients treated with a new drug-eluting stent formulation with low doses of sirolimus, built in an ultra-thin-strut platform coated with biodegradable abluminal coating. METHODS: This study is a randomized trial that tested the main hypothesis that the angiographic late lumen loss of the novel sirolimus-eluting stent is noninferior compared with commercially available biolimus-eluting stent. A final study population comprising 170 patients with one or two de novo lesions was randomized in the ratio 2:1 for sirolimus-eluting stent or biolimus-eluting stent, respectively. The primary endpoint was 9-month angiographic in-stent late lumen loss. Adverse clinical events were prospectively collected for 1 year. RESULTS: After 9 months, the novel sirolimus-eluting stent was shown noninferior compared with the biolimus stent for the primary endpoint (angiographic in-stent late lumen loss: 0.20 ± 0.29 mm vs. 0.15 ± 0.20 mm, respectively; P value for noninferiority <0.001). The 1-year incidence of death, myocardial infarction, repeat revascularization, and stent thrombosis remained low and not significantly different between the groups. CONCLUSIONS: The present randomized trial demonstrates that the tested novel sirolimus-eluting stent was angiographically noninferior in comparison with a last-generation biolimus-eluting stent.

Adequação das práticas do laboratório de cateterismo durante a pandemia de COVID-19: o protocolo do Instituto Dante Pazzanese de Cardiologia / Adapted Catheterization Laboratory Practices during the COVID-19 Pandemic: The Instituto Dante Pazzanese de Cardiologia Protocol

Introdução A pandemia global da doença de coronavírus 2019 (COVID-19) causada pelo novo vírus de síndrome respiratória aguda grave coronavírus 2 (SARS-CoV-2) começou em Wuhan, China, em dezembro de 2019 e afetou mais de 4,4 milhões de pessoas em todo o mundo, com 302.169 mortes até o dia 16 de maio de 2020.1 Embora os sintomas respiratórios sejam a apresentação mais comum de COVID-19, o envolvimento cardíaco é uma característica proeminente dessa doença, ocorrendo em 20% a 30% dos pacientes hospitalizados e contribuindo para 40% dos óbitos.2-4 O envolvimento cardíaco relacionado à COVID-19 tem sido documentado por elevações em biomarcadores cardíacos e frequentemente apresenta alterações no segmento ST-T no eletrocardiograma (ECG) de 12 derivações, motivo pelo qual a equipe do laboratório de cateterismo é frequentemente ativada. Além disso, as atividades do laboratório de cateterismo devem continuar no atendimento a pacientes não COVID-19 que apresentam síndrome coronariana aguda (SCA) verdadeira, infarto do miocárdio com supradesnivelamento do segmento ST (IAMCSST) e doença cardíaca isquêmica estável muito sintomática. Devido à escalada no número de casos de COVID-19 na cidade de São Paulo, epicentro da doença no Brasil, reformularam-se a logística e as práticas no laboratório de cateterismo cardíaco do Instituto Dante Pazzanese de Cardiologia, que entraram em vigor em abril de 2020 e continuarão durante o período da pandemia. Os objetivos são fornecer atendimento otimizado à população que necessita de procedimentos cardíacos invasivos durante a pandemia, com a proteção adequada aos profissionais de saúde (PS), pacientes e seus familiares. Os protocolos aqui descritos representam os esforços multidisciplinares e dinâmicos do Departamento de Cardiologia Invasiva do Instituto Dante Pazzanese de Cardiologia validados pelo Comitê de Controle de Infecção da instituição. Essas práticas estão sujeitas a alterações em função do estado epidemiológico local, a fase da epidemia e a disponibilidade de equipamento de proteção individual (EPI). Estes protocolos podem não se aplicar a outras localidades sem casos (ou casos esporádicos) de COVID-19 ou a serviços que atendem diferentes perfis populacionais com logísticas e disponibilidade de EPI diversas.

Risk factors for acute myocardial infarction during the postoperative period of myocardial revascularization.

OBJECTIVE: To identify risk factors for acute myocardial infarction during the postoperative period after myocardial revascularization. METHODS: This was a case-control study paired for sex, age, number, type of graft used, coronary endarterectomy, type of myocardial protection, and use of extracorporeal circulation. We assessed 178 patients (89 patients in each group) undergoing myocardial revascularization, and the following variables were considered: dyslipidemia, systemic hypertension, smoking, diabetes mellitus, previous myocardial revascularization surgery, previous coronary angioplasty, and acute myocardial infarction. RESULTS: Baseline clinical characteristics did not differ in the groups, except for previous myocardial revascularization surgery, prevalent in the case group (34 patients vs. 12 patients; p = 0.0002). This was the only independent predictor of risk for acute myocardial infarction in the postoperative period, based on a multivariate logistic regression analysis (p = 0.0001). Mortality and the time of hospital stay of the case group were significantly higher (19.1% vs. 1.1%; p < 0.001 and 15.7 days vs. 10.6 days; p < 0.05 respectively) than those of the control. CONCLUSION: Only previous myocardial revascularization was an independent predictor of acute myocardial infarction in the postoperative period, based on multivariate logistic regression analysis.

Percutaneous implantation of endoprostheses in the carotid arteries.

OBJECTIVE: To assess the in-hospital evolution of patients undergoing percutaneous stent placement in the carotid arteries. METHODS: From August 1996 to April 2001, we studied 86 patients with carotid arterial obliterative lesions > 70% who were treated with percutaneous stent placement in the carotid arteries. We assessed the rate of success of the implantation and of the procedure, the types of stents used, mortality rate, and neurological complications. RESULTS: Successful implantation was obtained in 98.9% of the cases, and the procedure was successful in 91.8%. The Wallstent was the most frequently used stent (73 patients - 77%). Cerebral strokes occurred as follows: 3 (3.2%) transient ischemic attacks, 1 (1.1%) minor stroke, and 3 (3.1%) major strokes. One (1.1%) patient died during hospitalization. CONCLUSION: The high rate of success of stent implantation (98.9%) in addition to the low rate of cerebral stroke/death (4.2%) showed the efficiency and safety of percutaneous stent placement in carotid arteries.

Very long-term follow-up of strut apposition and tissue coverage with Biolimus A9 stents analyzed by optical coherence tomography.

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

Assessment of drug-eluting stents and bioresorbable stents by grayscale IVUS and IVUS-based imaging modalities.

Grayscale IVUS and IVUS-based imaging modalities during the last years have become useful in the assessment not only of drug eluting stent, but also of new bioresorbable vascular scaffolds. Although IVUS resolution is not sufficient for determining stent coverage (optical coherence tomography is the gold standard), serial IVUS can measure intimal hyperplasia, assess acute and late incomplete stent apposition, detect the presence and persistence of edge dissections, study edge effects and look for causes of restenosis and thrombosis. In addition other IVUS-based imaging modalities, such as IVUS-VH, iMAP or palpography, can be used to study the serial compositional and mechanical changes of the plaque behind stent struts and also to follow the bioresorption of the new bioresorbable scaffolds, analyzing the backscattering signal coming from the polymeric struts. This review details and evaluates grayscale IVUS and IVUS-based techniques findings in clinical trials, highlighting the usefulness of these imaging modalities in the study of drug eluting stents and bioresorbable vascular scaffold.

Revascularização miocárdica no paciente diabético: intervenção coronariana percutânea / Myocardial revascularization in diabetic patients: percutaneous coronary intervention

O diabetes mellitus é uma doença metabólica complexa, presente em 20 por cento a 30 por cento dos indivíduos que necessitam revascularização miocárdica. Dados da literatura confirmam a superioridade da revascularização cirúrgica em relação à angioplastia com balão em diabéticos com doença multiarterial. A intervenção coronariana percutânea com o implante de stents diminuiu a vantagem da cirurgia, mas a necessidade de reintervenções ainda é maior com a angioplastuia. Mais recentemente, os stents farmacológicos tornaram-se a intervenção percutânea de escolha no tratamento da doença coronariana, pela notável redução da reestenose coronariana e da revascularização do vaso-alvo, quando comparados aos stents não-farmacológicos. A segurança dessas próteses, entretanto, tem sido questionada ultimamente, no que diz respeito à ocorrência da trombose tardia do stent...