Fábio Sândoli de Brito

Outcomes and predictors of mortality after transcatheter aortic valve implantation: Results of the Brazilian registry

The study sought to evaluate outcomes and predictors of mortality after transcatheter aortic valve implantation (TAVI).

Randomized evaluation of two drug-eluting stents with identical metallic platform and biodegradable polymer but different agents (paclitaxel or sirolimus) compared against bare stents: 1-year results of the PAINT trial.

Objectives: We tested two novel drug‐eluting stents (DES), covered with a biodegradable‐polymer carrier and releasing paclitaxel or sirolimus, which were compared against a bare metal stent (primary objective). The DES differed by the drug, but were identical otherwise, allowing to compare the anti‐restenosis effects of sirolimus versus paclitaxel (secondary objective). Background: The efficacy of novel DES with biodegradable polymers should be tested in the context of randomized trials, even when using drugs known to be effective, such as sirolimus and paclitaxel. Methods: Overall, 274 patients with de novo coronary lesions in native vessels scheduled for stent implantation were randomly assigned (2:2:1 ratio) for the paclitaxel (n = 111), sirolimus (n = 106), or bare metal stent (n = 57) groups. Angiographic follow‐up was obtained at 9 months and major cardiac adverse events up to 12 months. Results: Both paclitaxel and sirolimus stents reduced the 9‐month in‐stent late loss (0.54–0.44 mm, 0.32–0.43 mm, vs. 0.90–0.45 mm respectively), and 1‐year risk of target vessel revascularization and combined major adverse cardiac events (P < 0.05 for both, in all comparisons), compared with controls. Sirolimus stents had lower late loss than paclitaxel stents (P < 0.01), but similar 1‐year clinical outcomes. There were no differences in the risk of death, infarction, or stent thrombosis among the study groups. Conclusion: Both novel DES were effective in reducing neointimal hyperplasia and 1‐year re‐intervention, compared to bare metal stents. Our findings also suggest that sirolimus is more effective than paclitaxel in reducing angiographic neointima, although this effect was not associated with better clinical outcomes.© 2009 Wiley‐Liss, Inc.

Enhanced inflammatory response to coronary stenting marks the development of clinically relevant restenosis

Objectives: The aims of this study were to investigate the effect of coronary stenting on the release of cytokines and cell‐mediated immunity factors and to evaluate the association between inflammation and clinical outcomes at 6 months. Background: Circulating levels of inflammatory markers and cytokines are elevated in patients with acute coronary syndromes and are related to an unfavorable outcome. The aims of this study were to investigate the effect of coronary stenting on the release of cytokines and cell‐mediated immunity factors and to evaluate the association between inflammation and clinical outcomes at 6 months. Methods: Forty patients with single native coronary artery disease treated with stenting were enrolled. Peripheral venous blood samples were collected before and 6 h, 48 h, and 12 weeks after stenting. Serum concentrations of high‐sensitivity C‐reactive protein, interleukin‐6, interleukin‐8, tumor necrosis factor‐α (markers of inflammation) and serum‐soluble interleukin‐2 receptor for T‐lymphocyte activation (sIL2‐R, marker of cell‐mediated immunity) were measured. Patients also were evaluated clinically one, 3, and 6 months post‐stenting or when they presented with cardiovascular symptoms to identify major adverse cardiac events (cardiac death, MI, revascularization). Results: Concentrations of interleukins 6 and 8 and tumor necrosis factor‐α peaked at 6 h (11.0, 12.6, and 5.3 pg/ml, respectively). The peak level of high‐sensitivity C‐reactive protein (2.77 mg/dL) occurred 48 h post stenting, while sIL2‐R peaked (495 U/ml) at 12 weeks. Patients who experienced restenosis had higher levels of C‐reactive protein at 48 h (4.94 vs. 1.84 mg/dl; P = 0.043) and of IL‐8 at 6 h (26.75 vs. 13.55 pg/mL; P = 0.048) than those without restenosis. Conclusions: Proinflammatory cytokines and inflammatory markers are released into the peripheral circulation early after coronary stenting, and increased levels of some are associated with clinically relevant restenosis.

Predictors of permanent pacemaker requirement after transcatheter aortic valve implantation: insights from a Brazilian registry.

BACKGROUND The aim of this study is to evaluate the predictors of permanent pacemaker (PPM) implantation after TAVI. METHODS Between January 2008 and February 2012, 418 patients with severe aortic stenosis underwent TAVI and were enrolled in a Brazilian multicenter registry. After excluding patients who died during the procedure and those with a previous PPM, 353 patients were included in the analysis. RESULTS At 30 days, the overall incidence of PPM implantation was 25.2%. Patients requiring PPM were more likely to be older (82.73 vs. 81.10 years, p=0.07), have pre-dilation (68.42% vs. 60.07%, p=0.15), receive CoreValve (93.68% vs. 82.55%, p=0.008), and have baseline right bundle branch block (RBBB, 25.26% vs. 6.58%, p<0.001). On multivariable analysis, CoreValve vs. Sapien XT (OR, 4.24; 95% CI, 1.56-11.49; p=0.005), baseline RBBB (OR, 4.41; 95% CI, 2.20-8.82; p<0.001), and balloon pre-dilatation (OR, 1.75; 95% CI, 1.02-3.02; p=0.04) were independent predictors of PPM implantation. CONCLUSION PPM implantation occurred in approximately one-fourth of cases. Pre-existing RBBB, balloon pre-dilatation, and CoreValve use were independent predictors of PPM after TAVI. The type of prosthesis used and pre-balloon dilatation should be considered in TAVI candidates with baseline RBBB.

High versus low-pressure balloon inflation during Multilink™ stent implantation: Acute and long-term angiographic results

We compared the impact of low and high‐pressure balloon inflation on acute and late angiographic results of Multilink™ stent. Low‐pressure balloon inflation (9.5 ± 1.9 atm) was used in 43 stents and high pressure (17.1 ± 1.5 atm) in 44. A larger immediate luminal gain was achieved in stents with high‐pressure balloon inflation (1.80 ± 0.26 vs. 1.47 ± 0.62; P = 0.002), resulting in a larger mean diameter in this group (2.71 ± 0.37 vs. 2.48 ± 0.47; P = 0.017). At follow‐up, a larger luminal diameter was achieved in the high pressure group (1.93 ± 0.72 vs. 1.45 ± 0.66; P = 0.002) and a trend to a lower rate of angiographic restenosis (15% vs. 38%, P = 0.08). Cathet. Cardiovasc. Intervent. 50:398–401, 2000.

Hidratação com bicarbonato de sódio não previne a nefropatia de contraste: ensaio clínico multicêntrico

BACKGROUND Radiographic contrast media exposition can cause acute renal function impairment. There is limited and conflicting evidence that hydration with sodium bicarbonate prevents contrast-induced nephropathy (CIN) in patients undergoing cardiac catheterization. OBJECTIVE The present study was aimed at determining whether sodium bicarbonate is superior to hydration with saline to prevent nephropathy in patients at risk undergoing cardiac catheterization. METHODS Three hundred and one patients undergoing coronary angiography or percutaneous coronary intervention with serum creatinine > 1.2mg/dL or glomerular filtration rate (GFR) < 50 ml/min were randomized to receive hydration with sodium bicarbonate starting 1 hour before the procedure and 6 hours after the procedure, or hydration with 0.9% saline. CIN was defined as an increase of 0.5mg/dL in creatinine in 48 h RESULTS Eighteen patients (5.9%) developed contrast induced nephropathy: 9 patients in the bicarbonate group (6.1%) and 9 patients in the saline group (6.0%), p = 0.97. The change in serum creatinine was similar in both groups, 0.01 ± 0.26 mg/dL in the bicarbonate group and 0.01 ± 0.35 mg/dL in the saline group, p = 0.9. No statistical difference was observed between the change in glomerular filtration rate (0.89 ± 9 ml/min vs. 2.29 ± 10 ml/min, p = 0.2 bicarbonate group and saline group, respectively). CONCLUSION Hydration with sodium bicarbonate was not superior to saline to prevent contrast media induced nephropathy in patients at risk undergoing cardiac catheterization.

Late clinical outcomes after implantation of drug-eluting stents coated with biodegradable polymers: 3-year follow-up of the PAINT randomised trial

AIMS The long-term clinical performance of drug-eluting stents (DES) coated with biodegradable polymers is poorly known. METHODS AND RESULTS A total of 274 coronary patients were randomly allocated to paclitaxel-eluting stents, sirolimus-eluting stents, or bare metal stents (2:2:1 ratio). The two DES used the same biodegradable polymers and were identical except for the drug. At three years, the pooled DES population had similar rates of cardiac death or myocardial infarction (9.0% vs. 7.1; p=0.6), but lower risk of repeat interventions (10.0% vs. 29.9%; p<0.01) than controls with bare stents. The cumulative 3-year incidence of definite or probable stent thrombosis in the pooled DES group was 2.3% (first year: 1.8%; second year: 0.4%; third year: zero). There were no significant differences in outcomes between paclitaxel- and sirolimus-eluting stents. CONCLUSIONS The biodegradable-polymer coated DES releasing either paclitaxel or sirolimus were effective in reducing the 3-year rate of re-interventions.

Surgical cutdown versus percutaneous access in transfemoral transcatheter aortic valve implantation: Insights from the Brazilian TAVI registry

To compare the 1‐year outcomes of complete percutaneous approach versus surgical vascular approach for transfemoral transcatheter aortic valve implantation (TAVI), among “real‐world” patients from the multi‐center Brazilian TAVI registry.

Percutaneous aortic valve replacement for the treatment of aortic stenosis: early experience in Brazil

FUNDAMENTO: La sustitucion percutanea de la valvula aortica en el tratamiento de la estenosis aortica es una alternativa disponible y eficaz para pacientes de alto riesgo quirurgico, especialmente los de edad avanzada y comorbilidades. OBJETIVO: Los autores relatan la experiencia inicial del empleo de la endoprotesis CoreValve en nuestro medio. METODOS: En enero de 2008 se sometio a dos pacientes a la sustitucion percutanea de la valvula aortica por estenosis aortica sintomatica. A ambos se les selecciono por su edad avanzada (77 y 87 anos), comorbilidades y alto riesgo quirurgico (EuroScore 7,7% e 12,1%). RESULTADOS: Los implantes percutaneos del dispositivo CoreValve se realizaron exitosamente. Se observo la ampliacion del area valvular (de 0,7 para 1,5 cm2 y de 0,5 para 1,3 cm2) y la reduccion del gradiente transvalvular aortico (de 82 para 50 mmHg e de 94 para 31 mmHg) inmediatamente despues de la intervencion. Durante la internacion hospitalaria se hizo necesario implantar marcapasos definitivos en ambos pacientes, a causa de bloqueo atrioventricular. Se observo seis meses despues una queda aun mas grande del gradiente transvalvular aortico (gradiente < 20 mmHg) y la remision de los sintomas de insuficiencia cardiaca (NYHA III para NYHA I). CONCLUSION: El empleo de la endoprotesis CoreValve para el tratamiento de la estenosis aortica se revelo factible y los resultados, en esa experiencia inicial en nuestro medio, han sido prometedores.FUNDAMENTO: A substituicao percutânea da valva aortica para o tratamento da estenose aortica e uma alternativa disponivel e eficaz para pacientes com alto risco cirurgico, especialmente aqueles com idade avancada e comorbidades. OBJETIVO: Os autores relatam a experiencia inicial do emprego da endoprotese CoreValve em nosso meio. METODOS: Em janeiro de 2008, dois pacientes foram submetidos a substituicao percutânea da valva aortica por estenose aortica sintomatica. Ambos foram selecionados por terem idade avancada (77 e 87 anos), comorbidades e elevado risco cirurgico (EuroScore 7,7% e 12,1%). RESULTADOS: Os implantes percutâneos do dispositivo CoreValve foram realizados com sucesso. Observou-se a ampliacao da area valvar (de 0,7 para 1,5 cm2 e de 0,5 para 1,3 cm2) e a reducao do gradiente transvalvar aortico (de 82 para 50 mmHg e de 94 para 31 mmHg) imediatamente apos a intervencao. Durante a internacao hospitalar, houve a necessidade de implantar marca-passos definitivos nos dois pacientes, por bloqueio atrio-ventricular. Aos seis meses, observou-se a queda ainda maior do gradiente transvalvar aortico (gradiente < 20 mmHg), e a remissao dos sintomas de insuficiencia cardiaca (NYHA III para NYHA I). CONCLUSAO: O emprego da endoprotese CoreValve para o tratamento da estenose aortica mostrou-se factivel e com resultados animadores nesta experiencia inicial em nosso meio.BACKGROUND Percutaneous aortic valve replacement for the treatment of aortic stenosis is an available and efficient alternative for patients at high surgical risk, especially those with advanced age and comorbidities. OBJECTIVE The authors report the first experience made in our midst with the use of the CoreValve endoprosthesis. METHODS In January 2008, two patients underwent percutaneous aortic valve replacement due to symptomatic aortic stenosis. They were selected for being elderly (77 and 87 years) and presenting comorbidities and a high surgical risk (EuroScore 7.7% and 12.1%). RESULTS Percutaneous implantations of the CoreValve device were successfully performed. Enlargement of the valve area (from 0.7 to 1.5 cm(2) and from 0.5 to 1.3 cm(2)) and reduction of the aortic transvalvular gradient (from 82 to 50 mmHg and from 94 to 31 mmHg) were observed immediately after the intervention. During hospital stay, permanent pacemaker implantation was required in both patients due to atrioventricular block. At six months, an even greater drop in the aortic transvalvular gradient (gradient < 20 mmHg) and remission of symptoms of heart failure (NYHA III to NYHA I) were observed. CONCLUSION The use of the CoreValve endoprosthesis for the treatment of aortic stenosis proved to be feasible and showed encouraging results in this early experience made in our midst.

Pregnancy-associated spontaneous coronary artery dissection: insights from a case series of 13 patients.

Aims We sought to present a series of 13 pregnancy-associated spontaneous coronary artery dissection (P-SCAD), their angiographic and multimodal imaging findings, acute phase treatment, and outcomes. Methods and results Between 2005 and 2015, 13 cases of P-SCAD were collected from a database of 11 tertiary hospitals. The mean age was 33.8 ± 3.7 years; most patients had no risk factors for coronary artery disease, and the majority were multiparous. P-SCAD occurred during the puerperium in 12 patients with a median time of 10 days. Only one patient presented with P-SCAD in the 37th week of pregnancy, and she was the only patient who died in this series. Six patients (46%) presented with ST-segment elevation acute myocardial infarction (STEMI), six (46%) presented with non-STEMI, and one presented with unstable angina; one-third of women had cardiogenic shock. In 12 patients, the dissection involved the left anterior descending or circumflex artery, and it extended to the left main coronary artery in 6 patients. Intravascular ultrasound or optical coherence tomography helped to confirm diagnosis and guide treatment in 46% of cases. Seven women were managed clinically; percutaneous coronary intervention was performed in five cases, and coronary artery bypass grafting was performed in one patient. Conclusion In these 13 cases of P-SCAD, clinical presentation commonly included acute myocardial infarction and cardiogenic shock. Multivessel dissections and involvement of the left coronary artery and left main coronary artery were highly prevalent. Clinicians must be aware of angiographic appearances of P-SCAD for prompt diagnosis and management in these high-risk patients.