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.

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

Abstract: Objectives. 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 single-center, retrospective analysis of all 1582 patients with severe mitral stenosis who underwent PMBC from August 1987 to July 2010. The composite outcome was cardiovascular death, new PMBC, or mitral valve repair surgery up to 24 years of follow-up. 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=.01), left atrium size (OR, 0.96; 95% CI, 0.93-0.99; P=.01), mean preprocedure mitral gradient (OR, 0.93; 95% CI, 0.89-0.96; P<.001), intermediate Wilkins score 9-11 (OR, 0.62; 95% CI, 0.40-0.94; P=.02), and high Wilkins score ≥12 (OR, 0.35; 95% CI, 0.16-0.76; P<.01). For prediction of late events, age (hazard ratio [HR], 0.98; 95% CI, 0.97-0.98; P<.001), New York Heart Association class III-IV (HR, 1.50; 95% CI, 1.18-1.92; P<.001), left atrium size (HR, 1.02; 95% CI, 1.02-0.04; P<.01), and high Wilkins score ≥12 (HR, 2.02; 95% CI, 1.30-3.15; P<.01) were significant. Two nomograms were developed using significant predictors from the model. 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.

Very Long Term Follow-Up After Percutaneous Balloon Mitral Valvuloplasty

OBJECTIVES: The aim of this study was to assess very long term outcomes after successful percutaneous balloon mitral valvuloplasty (PBMV).BACKGROUND: PBMV remains the preferred treatment for patients with severe symptomatic rheumatic mitral stenosis and suitable anatomy.METHODS: All consecutive patients who underwent successful PBMV between 1987 and 2010 were included. The primary endpoint was the composite of all-cause mortality, need for mitral surgery, or repeat PBMV up to 23 years.RESULTS: Among all 1,582 consecutive patients undergoing PBMV, acute success was achieved in 90.9% (n»1,438).Independent predictors of acute success included left atrial size (odds ratio: 0.96; 95% confidence interval [CI]: 0.93 to0.99; p»0.045), Wilkins score#8 (odds ratio: 1.66; 95% CI: 0.48 to 0.93; p»0.02) and age (odds ratio: 0.97; 95% CI:0.96 to 0.99; p»0.006). Very long-term follow-up (median 8.3 years, mean 15.6 years) was obtained in 79.1% of successful cases. The incidence of the primary endpoint was 19.1% (95% CI: 17.0% to 21.1%). The rates of overall lmortality, need for mitral valve surgery, or repeat PBMV were 0.6% (95% CI: 0.3% to 1.2%), 8.3% (95% CI: 7.0% to9.9%), and 10.0% (95% CI: 8.5% to 11.7%), respectively. On multivariate analysis, New York Heart Association functional class III or IV (hazard ratio: 1.62; 95% CI: 1.26 to 2.09; p<0.001), higher age (hazard ratio: 0.97; 95% CI: 0.96 to0.98; p»0.028), and mitral valve area#1.75 cm2after the procedure (hazard ratio: 1.67; 95% CI: 1.28 to 2.11;p»0.028) were independent predictors of the primary endpoint. CONCLUSIONS: In very long term follow-up, more than 75% of patients exhibited sustained results. Prediction of late favorable results is multifactorial and strongly determined by age, previous symptoms and post-procedural mitral valve area.(J Am Coll Cardiol Intv 2018;11:1945­52) © 2018 by the American College of Cardiology Foundation.

Drug-Coated Balloons: Hope or Hot Air: Update on the Role of Coronary DCB

Purpose of review: The present manuscript reviews the mechanism of action of drug-coated balloons (DCBs), offering a brief summary of the main clinical evidence on these devices. Recent findings: DCBs are regular semi-compliant balloons coated with antiproliferative agents that are rapidly released on contact with the vessel intima, exerting an anti-restenotic effect. This technology may offer some benefits of drug-eluting stents, in particular for the treatment of restenotic lesions, small vessels, and in patients at high-bleeding risk, when the prolonged dual antiplatelet regimen should be avoided. Most recent data have pointed to a possible benefit of these devices in treating bare metal stents (BMS) or drug-eluting stents in-stent restenosis (DES ISR), effectively reducing the recurrence of restenosis and avoiding additional layers of metal in the same coronary segment. In other clinical scenarios such as bifurcations, small vessels, and de novo lesions, data is more scarce and the benefits are still unclear. There are potential benefits related to the use of DCB in selected populations. However, larger clinical trials with longer follow-up are still needed to confirm the enthusiastic initial results.

Perspectivas futuras e novos dispositivos transcateter no tratamento da estenose aórtica / Future perspectives and new transcatheter devices in the treatment of aortic tenosis

O implante de prótese valvar aórtica por cateter (TAVI, do inglês transcatheter aortic valve implantation) constitui o tratamento de escolha para pacientes com estenose aórtica considerada inoperável e surge como opção terapêutica à cirurgia em indivíduos com alto e moderado risco operatório. Embora excelentes resultados clínicos sejam obtidos com as próteses primeiramente disponibilizadas para uso clínico, a ocorrência de complicações ­ como acidente vascular cerebral (AVC), regurgitação (leak) paraprotética, distúrbios de condução com implante de marca-passo (MP) e complicações vasculares ­ deve ser prevenida. As novas próteses têm como características primordiais: menor calibre dos instrumentais, implante valvar mais seguro e previsível e a incorporação de características no arcabouço das próteses que reduzam a ocorrência de refluxo paravalva

Transcatheter aortic valve implantation (TAVI) is the treatment of choice for patients with aortic stenosis that is considered inoperable, and has emerged as a treatment option to surgery in individuals with high to moderate surgical risk. Although excellent clinical results have been obtained with the prostheses primarily provided for clinical use, the occurrence of complications ­ such as cerebral stroke, paraprosthetic regurgitation (leak), pacemaker (MP) implant conduction disorders, and vascular complications ­ should be prevented. The main characteristics of the new prostheses are: narrower instruments, a safer, more predictable valve implant, and the incorporation of characteristics in the framework of the prostheses that reduce the occurrence of paravalvular leaks

Impact of the occlusion duration on the performance of j-cto score in predicting failure of percutaneous coronary intervention for chronic total occlusion

Abstract: Objectives. The present study examined the association between Multicenter CTO Registry in Japan (J-CTO) score in predicting failure of percutaneous coronary intervention (PCI) correlating with the estimated duration of chronic total occlusion (CTO). Background. The J-CTO score does not incorporate estimated duration of the occlusion. Methods. This was an observational retrospective study that involved all consecutive procedures performed at a single tertiary-care cardiology center between January 2009 and December 2014. Results. A total of 174 patients, median age 59.5 years (interquartile range [IQR], 53-65 years), undergoing CTO-PCI were included. The median estimated occlusion duration was 7.5 months (IQR, 4.0-12.0 months). The lesions were classified as easy (score = 0), intermediate (score = 1), difficult (score = 2), and very difficult (score ≥3) in 51.1%, 33.9%, 9.2%, and 5.7% of the patients, respectively. Failure rate significantly increased with higher J-CTO score (7.9%, 20.3%, 50.0%, and 70.0% in groups with J-CTO scores of 0, 1, 2, and ≥3, respectively; P0.70...

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

OBJECTIVES: The objectives of the present study were to analyze the variation of renal function after transcatheter aortic valve replacement (TAVR) focused on acute kidney injury (AKI) and its impact on short- and mid-term mortality. BACKGROUND: Changes on renal function after TAVR and their impact on clinical outcomes are incompletely understood until now. METHODS: At two tertiary centers 221 consecutive patients were submitted to TAVR. Kidney injury was defined according to VARC-2 criteria. Patients were classified according to the presence (group 1) or absence (group 2) of AKI. Creatinine values were collected daily until seventh day after procedure, 1 month, 6 months, and then 1 year after TAVR.RESULTS:At baseline, groups were similar, except for EuroSCORE II (8.66% vs. 7.34%, P = 0.02) and glomerular filtration rate (GFR) (39.59 vs. 48.49 mL/min.1.73 m2 , P = 0.002). Overall 30 day-mortality and 1-year mortality were 6.3% and 14.0%, respectively. Both 30-day mortality (23.1% vs. 1.2%, P < 0.001) and 1-year mortality (44.2% vs. 4.7%, P < 0.001) were higher in group 1. After multivariable-adjusted models, the only independent predictor for AKI after TAVR was baseline GFR (HR: 1.37, 95% CI: 1.08-1.77, P = 0.01). The independent risk factors for 1-year mortality were AKI (HR: 15.66, 95% CI: 6.07-44.63, P < 0.001), COPD (HR: 3.14, 95% CI: 1.05-9.40, P = 0.04) and aortic regurgitation grade postprocedure ≥ 2 (P = 0.05) also after multivariate analysis...

Embolic protection devices in percutaneous coronary intervention

Clinical benefit of percutaneous coronary intervention (PCI) depends on both angiographic success at lesion site as well as the restoration of adequate macro and microvascular perfusion. The pathophysiology of embolization from coronary lesions during PCI is multifactorial, being more frequently observed in patients with acute coronary syndrome and in those with lesions at saphenous vein graft (SVG). In this population, despite successful epicardial intervention, distal tissue perfusion may still be absent in up to a quarter of all PCI. Multiple devices and pharmacologic regimens have been developed and refined in an attempt to protect the microvascular circulation during PCI. Among them, embolic protection devices have raised as an attractive adjunctive toll due to their ability to retain debris and potentially prevent distal embolization, reducing major adverse cardiac events. Currently, their use has been validated for the treatment of SVG lesions but failed to show effectiveness in the percutaneous approach of acute coronary syndrome patients, including those with ST elevation myocardial infarction.

Papel emergente do eixo GH/IGF-I no controle cardiometabólico / Emerging role of the GH/IGF-I on cardiometabolic control / Rol emergente del eje GH/IGF-I en el control cardiometabólico

O hormônio de crescimento (GH), principal regulador do crescimento pós-natal, tem importantes ações metabólicas em diferentes tecidos, sinérgicas ou até antagônicas às do fator de crescimento semelhante à insulina tipo I (IGF-I), produzido sobretudo no fígado após ligação do GH ao seu receptor. Experimentos em modelos animais indicam um papel importante do GH na resistência a insulina, enquanto o papel do IGF-I nessa condição ainda não está completamente elucidado. Em humanos, o GH promove aumento da lipólise e da oxidação lipídica, enquanto o IGF-I desencadeia o aumento da oxidação lipídica apenas cronicamente. Enquanto as ações sobre o crescimento são tempo limitado, as ações metabólicas e cardiovasculares do eixo GH/IGF-I perduram durante toda a vida. Os potenciais efeitos anabólicos do GH têm sido utilizados em condições crônicas e hipercatabólicas, embora as investigações sobre os desfechos clínicos ainda sejam escassas. Neste artigo, pretendemos revisar as ações metabólicas do GH oriundas de modelos animais, os estudos em humanos normais e indivíduos com deficiência de GH, diabete melito tipo 1, síndrome metabólica, estados hipercatabólicos e a relação do eixo GH/IGF-I com as adipocinas, disfunção endotelial e aterogênese.

Growth hormone (GH), the main regulator for post-natal growth, has important metabolic actions on different tissues, similar or opposite to insulin like growth factor I (IGF-I), mainly produced by the liver after the binding of GH to its receptor. Experiments with animal models indicate an important role of GH on insulin resistance although the IGF-I role is not yet completely established. In humans, GH promotes an increase on lypolisis and lipid oxidation, while IGF-I leads to an increase on lipid oxidation only in a chronic way. While growth actions are time-limited, metabolic and cardiovascular actions of the GH/IGF-I axis are throughout life. GH anabolic effects have been used on chronic and hypercatabolic conditions, although investigations on the clinical outcomes are still scarce. In this paper, we intend to review GH metabolic actions experienced by animal models, studies with normal humans and GH deficient individuals, individuals with diabetes mellitus type 1 and metabolic syndrome individuals, hypercatabolic states and the relationship between GH and adipokines, endothelial disfunction and atherogenesis.

la hormona de crecimiento (GH), principal regulador del crecimiento postnatal, tiene importantes acciones metabólicas en diversos tejidos, sinérgicas o incluso antagónicas a las del factor de crecimiento, a semejanza de la insulina tipo I (IGF-I) producido, principalmente, en el hígado y después del vínculo del GH con su receptor. Experimentos en modelos animales indican un papel importante del GH en la resistencia a la insulina, mientras que el papel del IGF-I en esa condición, todavía no está completamente elucidado. En los humanos, el GH genera el aumento de la lipólisis y de la oxidación lipídica, mientras que el IGF-I desencadena el aumento de la oxidación lipídica solamente desde el punto de vista crónico. Mientras las acciones sobre el crecimiento son de tiempo limitado, las acciones metabólicas y cardiovasculares del eje GH/IGF-I duran toda la vida. Los efectos potenciales anabólicos del GH han sido utilizados en condiciones crónicas e hipercatabólicas, aunque las investigaciones sobre los desenlaces clínicos todavía sean escasas. En este artículo, pretendemos revisar las acciones metabólicas del GH provenientes de modelos animales, los estudios en humanos normales y en individuos con deficiencia de GH, diabetes mellitus tipo 1, síndrome metabólico, estados hipercatabólicos y la relación del eje GH/IGF-I con las adipocinas, disfunción endotelial y aterogénesis.

Novas opções e preparações na terapia com hormônio de crescimento / News options and preparations in growth hormone therapy

Nos últimos 20 anos, o hormônio de crescimento recombinante humano (GHhr) vem sendo utilizado para tratar a deficiência do hormônio de crescimento (GH) em crianças e, mais recentemente, em adultos. Porém, a necessidade de injeções diárias compromete a aderência ao tratamento. Esforços de melhorar esta aderência incluem o uso de canetas e dispositivos desprovidos de agulha, haja vista que as bombas de infusão, nem sempre são fisiológicas e são de uso restrito. Quando a finalidade do tratamento for o crescimento, a terapêutica diária com GHhr continua a mais recomendada. Contudo, a expansão da terapêutica com GH, especialmente nos usos mais recentes e em adultos, necessitará de outras preparações. No momento atual, os secretagogos orais não têm eficácia comprovada para a utilização clínica, e as formulações de depósito de GHRH e de GH, que melhorariam a aderência dos pacientes, ainda requerem mais estudos de eficácia em longo prazo e segurança.

In the last twenty years, recombinant human Growth hormone (hrGH) has been available for the treatment of Growth Hormone Deficiency (GHD) in children and more recently in adults. However, the necessity of daily injections compromises the patient's compliance. Attempts to improve this compliance includes the use of pens and needle free devices, once the infusion pumps, not always physiologic, are of restricted use. When growth is the purpose of treatment, daily subcutaneous hrGH is still the most indicated. Nevertheless the expansion of GH replacement to new uses and especially in adults will need new preparations. Nowadays, the oral secretagogues have not proved efficacy to be used in clinical practice and the slow- release preparations of GH and GH releasing hormone that could improve the patient's compliance will need to be studied considering long term efficacy and safety.