Safety and Effectiveness of Suture-mediated Arterial Closure Device in Hepatocellular Carcinoma Patients Who Underwent Drug-Eluting Beads Transarterial Chemoembolization.

BACKGROUND: The number of transarterial percutaneous procedures has risen over the years, consequently reducing puncture site related complications has become a necessity. To this end, the use of arterial closure devices has been growing progressively and their benefits have become a focus of research. The purpose of this study is to assess the safety and effectiveness of a suture-mediated closure device, Perclose ProGlide® (Abbott Vascular, Redwood City, CA), in patients with liver disease and hepatocellular carcinoma who underwent transarterial liver chemoembolization with drug-eluting beads. MATERIALS AND METHODS: A cohort of 253 hepatocellular carcinoma patients who underwent 449 procedures of transarterial liver chemoembolization with drug-eluting beads using the Perclose Proglide device was prospectively studied. The main endpoints evaluated were the technical success of the device, defined as complete hemostasis achieved within 3 min after the closure, and the incidence of puncture-site complications. The secondary endpoints evaluated were the correlation between epidemiological factors, coagulation profile and degree of liver disease, and the occurrence of complications. RESULTS: Technical success was achieved in 96% of the cases. Among patients who underwent repeated procedures using the same vascular access, this rate was 95.3%. Puncture-site complications were observed in 7 procedures (1.56%); 4 (0.89%) were due to hemorrhage, 2 (0.44%) hematomas and 2 (0.44%) pseudoaneurysms; 2 (0.44%) due to limb ischemia; and 1 (0.22%) due to arterial dissection. Among them, 3 cases required intervention. The statistical analysis of demographic characteristics, Child-Pugh classification, and coagulation status did not show a significant correlation with the occurrence of complications. Of the 449 procedures, only 4 (0.89%) needed hospitalization due to puncture-site complications. CONCLUSIONS: The use of Perclose Proglide is safe and effective in patients with liver disease and hepatocellular carcinoma who underwent transarterial liver chemoembolization with drug-eluting beads.

Gender-related differences on short- and long-term outcomes of patients undergoing transcatheter aortic valve implantation.

OBJECTIVES: This study aimed to compare gender-related differences in outcomes of patients undergoing TAVI over a long-term follow-up period. BACKGROUND: Transcatheter aortic valve implantation (TAVI) has been considered the standard therapy for patients with inoperable or high-risk symptomatic aortic stenosis. The influence of gender-related differences in outcomes of patients undergoing TAVI is currently on debate. METHODS: From January 2008 to January 2015, 819 patients (49% men) underwent TAVI and were included in a multicenter Brazilian registry. Patients were followed-up and clinical outcomes were evaluated according to the updated Valve Academic Research Consortium-2 criteria. RESULTS: Mean follow-up was 497 ± 478 days. Compared with women, men had a lower rate of major or life-threatening bleeding (12.0% vs. 20.6%; HR = 0.57 [95CI% 0.40-0.81]; P = 0.001), and major vascular complications (6% vs. 11.7%; HR = 0.50 [95CI% 0.31-0.82]; P = 0.004). At 30 days, all-cause mortality was lower in men than in women (6.5% vs. 11.5%; P = 0.013), however, cumulative all-cause mortality was similar between groups (25.9% vs. 29.7%, men and women, respectively, HR = 0.92 [95CI% 0.71-1.19]; P = 0.52) over the entire follow-up period. By adjusted Cox regression model, renal function, diabetes, peripheral artery disease, and chronic obstructive pulmonary disease (COPD) remained independently predictors of all-cause mortality. CONCLUSIONS: In this large-scale study evaluating patients undergoing TAVI, 30-day mortality was higher among women than men driven by significant higher rates of major or life-threatening bleeding and major vascular complications. However, all-cause mortality on long-term follow-up was similar between groups. © 2016 Wiley Periodicals, Inc.

Clinical, angiographic, and intravascular ultrasound results of the VestSaync II trial.

AIM: We sought to assess the long term efficacy of the novel VESTAsync™ Eluting Stent (VES) combining a Cro-Co platform with a nanothin-microporous hydroxyapatite surface coating impregnated with a polymer-free low-dose of Sirolimus (55 µg). METHODS: The Vestasync II trial was a randomized (2:1), double-blinded, multicenter comparison of the VES to its platform, the Gen X stent, with microporous hydroxyapatite surface coating without sirolimus. Patients were eligible if they presented de novo lesions in native coronary arteries with 3.0-3.5 mm diameter and ≤ 14 mm in length. Primary endpoint was 8-month in-stent late loss and % of stent obstruction. Lifelong aspirin and 6-month clopidogrel were prescribed to all patients. RESULTS: Seventy-five patients were enrolled (VES = 50 pts). Baseline characteristics included mean age of 58 years and 29% of diabetics. Reference vessel diameter and lesion length were 2.8 ± 0.4 mm and 13.0 ± 2.0 mm, respectively. In-stent late loss (0.39 ± 0.20 vs. 0.74 ± 0.52, P = 0.03) and % of neointima hyperplasia (9.3 ± 6.6% vs. 17.6 ± 9.4%, P = 0.0016) were significantly reduced in the VES cohort. Up to 1 year, there was a single case of myocardial infarction and one target lesion revascularization (TLR) (2%) in the VES group while in the control cohort there were one TLR (4%) and one cardiac death (4%). CONCLUSION: The VestSync II trial is a proof-of-concept study and demonstrates the sustained efficacy of this novel polymer-free sirolimus drug-eluting stents. A larger trial, with more complex lesions, clinical endpoints and longer FU period is warranted. © 2013 Wiley Periodicals, Inc.

Three vs twelve months of dual antiplatelet therapy after zotarolimus-eluting stents: the OPTIMIZE randomized trial.

IMPORTANCE: The current recommendation is for at least 12 months of dual antiplatelet therapy after implantation of a drug-eluting stent. However, the optimal duration of dual antiplatelet therapy with specific types of drug-eluting stents remains unknown. OBJECTIVE: To assess the clinical noninferiority of 3 months (short-term) vs 12 months (long-term) of dual antiplatelet therapy in patients undergoing percutaneous coronary intervention (PCI) with zotarolimus-eluting stents. DESIGN, SETTING, AND PATIENTS: The OPTIMIZE trial was an open-label, active-controlled, 1:1 randomized noninferiority study including 3119 patients in 33 sites in Brazil between April 2010 and March 2012. Clinical follow-up was performed at 1, 3, 6, and 12 months. Eligible patients were those with stable coronary artery disease or history of low-risk acute coronary syndrome (ACS) undergoing PCI with zotarolimus-eluting stents. INTERVENTIONS: After PCI with zotarolimus-eluting stents, patients were prescribed aspirin (100-200 mg daily) and clopidogrel (75 mg daily) for 3 months (n = 1563) or 12 months (n = 1556), unless contraindicated because of occurrence of an end point. MAIN OUTCOMES AND MEASURES: The primary end point was net adverse clinical and cerebral events (NACCE; a composite of all-cause death, myocardial infarction [MI], stroke, or major bleeding); the expected event rate at 1 year was 9%, with a noninferiority margin of 2.7%. Secondary end points were major adverse cardiac events (MACE; a composite of all-cause death, MI, emergent coronary artery bypass graft surgery, or target lesion revascularization) and Academic Research Consortium definite or probable stent thrombosis. RESULTS: NACCE occurred in 93 patients receiving short-term and 90 patients receiving long-term therapy (6.0% vs 5.8%, respectively; risk difference, 0.17 [95% CI, -1.52 to 1.86]; P = .002 for noninferiority). Kaplan-Meier estimates demonstrated MACE rates at 1 year of 8.3% (128) in the short-term group and 7.4% (114) in the long-term group (HR, 1.12 [95% CI, 0.87-1.45]). Between 91 and 360 days, no statistically significant association was observed for NACCE (39 [2.6%] vs 38 [2.6%] for the short- and long-term groups, respectively; HR, 1.03 [95% CI, 0.66-1.60]), MACE (78 [5.3%] vs 64 [4.3%]; HR, 1.22 [95% CI, 0.88-1.70]), or stent thrombosis (4 [0.3%] vs 1 [0.1%]; HR, 3.97 [95% CI, 0.44-35.49]). CONCLUSIONS AND RELEVANCE: In patients with stable coronary artery disease or low-risk ACS treated with zotarolimus-eluting stents, 3 months of dual antiplatelet therapy was noninferior to 12 months for NACCE, without significantly increasing the risk of stent thrombosis. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01113372.

Optimized duration of clopidogrel therapy following treatment with the Endeavor zotarolimus-eluting stent in real-world clinical practice (OPTIMIZE) trial: rationale and design of a large-scale, randomized, multicenter study.

BACKGROUND: Current recommendations for antithrombotic therapy after drug-eluting stent (DES) implantation include prolonged dual antiplatelet therapy (DAPT) with aspirin and clopidogrel ≥12 months. However, the impact of such a regimen for all patients receiving any DES system remains unclear based on scientific evidence available to date. Also, several other shortcomings have been identified with prolonged DAPT, including bleeding complications, compliance, and cost. The second-generation Endeavor zotarolimus-eluting stent (E-ZES) has demonstrated efficacy and safety, despite short duration DAPT (3 months) in the majority of studies. Still, the safety and clinical impact of short-term DAPT with E-ZES in the real world is yet to be determined. METHODS: The OPTIMIZE trial is a large, prospective, multicenter, randomized (1:1) non-inferiority clinical evaluation of short-term (3 months) vs long-term (12-months) DAPT in patients undergoing E-ZES implantation in daily clinical practice. Overall, 3,120 patients were enrolled at 33 clinical sites in Brazil. The primary composite endpoint is death (any cause), myocardial infarction, cerebral vascular accident, and major bleeding at 12-month clinical follow-up post-index procedure. CONCLUSIONS: The OPTIMIZE clinical trial will determine the clinical implications of DAPT duration with the second generation E-ZES in real-world patients undergoing percutaneous coronary intervention.

Hypotheses, rationale, design, and methods for prognostic evaluation of cardiac biomarker elevation after percutaneous and surgical revascularization in the absence of manifest myocardial infarction. A comparative analysis of biomarkers and cardiac magnetic resonance. The MASS-V Trial.

BACKGROUND: Although the release of cardiac biomarkers after percutaneous (PCI) or surgical revascularization (CABG) is common, its prognostic significance is not known. Questions remain about the mechanisms and degree of correlation between the release, the volume of myocardial tissue loss, and the long-term significance. Delayed-enhancement of cardiac magnetic resonance (CMR) consistently quantifies areas of irreversible myocardial injury. To investigate the quantitative relationship between irreversible injury and cardiac biomarkers, we will evaluate the extent of irreversible injury in patients undergoing PCI and CABG and relate it to postprocedural modifications in cardiac biomarkers and long-term prognosis. METHODS/DESIGN: The study will include 150 patients with multivessel coronary artery disease (CAD) with left ventricle ejection fraction (LVEF) and a formal indication for CABG; 50 patients will undergo CABG with cardiopulmonary bypass (CPB); 50 patients with the same arterial and ventricular condition indicated for myocardial revascularization will undergo CABG without CPB; and another 50 patients with CAD and preserved ventricular function will undergo PCI using stents. All patients will undergo CMR before and after surgery or PCI. We will also evaluate the release of cardiac markers of necrosis immediately before and after each procedure. Primary outcome considered is overall death in a 5-year follow-up. Secondary outcomes are levels of CK-MB isoenzyme and I-Troponin in association with presence of myocardial fibrosis and systolic left ventricle dysfunction assessed by CMR. DISCUSSION: The MASS-V Trial aims to establish reliable values for parameters of enzyme markers of myocardial necrosis in the absence of manifest myocardial infarction after mechanical interventions. The establishments of these indices have diagnostic value and clinical prognosis and therefore require relevant and different therapeutic measures. In daily practice, the inappropriate use of these necrosis markers has led to misdiagnosis and therefore wrong treatment. The appearance of a more sensitive tool such as CMR provides an unprecedented diagnostic accuracy of myocardial damage when correlated with necrosis enzyme markers. We aim to correlate laboratory data with imaging, thereby establishing more refined data on the presence or absence of irreversible myocardial injury after the procedure, either percutaneous or surgical, and this, with or without the use of cardiopulmonary bypass.

Comparative clinical performance of two types of drug-eluting stents with abluminal biodegradable polymer coating: Five-year results of the DESTINY randomized trial.

INTRODUCTION AND OBJECTIVES: The Stents Coated With the Biodegradable Polymer on Their Abluminal Faces and Elution of Sirolimus Versus Biolimus Elution for the Treatment of de Novo Coronary Lesions - DESTINY Trial is a non-inferiority randomized study that compared the Inspiron™ sirolimus-eluting stent (SES) with the control Biomatrix™ Flex biolimus-eluting stent (BES). Previous reports in the first year showed similar outcomes for both stents, in clinical, angiographic, optical coherence tomography, and intravascular ultrasound assessments. The present analysis aims to compare the clinical performance of these two biodegradable polymer drug-eluting stents five years after the index procedure. METHODS: A total of 170 patients (194 lesions) were randomized in a 2:1 ratio for treatment with SES or BES, respectively. The primary endpoint for the present study was the five-year rate of combined major adverse cardiac events, defined as cardiac death, myocardial infarction, or target lesion revascularization. RESULTS: At five years, the primary endpoint occurred in 12.5% and 17.9% of the SES and BES groups, respectively (p=0.4). There was no definite or probable stent thrombosis among patients treated with the novel SES stent during the five years of follow-up, and no stent thrombosis after the first year in the BES group. CONCLUSIONS: The novel Inspiron™ stent had similar good clinical performance in long-term follow-up when compared head-to-head with the control latest-generation Biomatrix™ Flex biolimus-eluting stent.

Diagnostic Accuracy of 320-Row Computed Tomography for Characterizing Coronary Atherosclerotic Plaques: Comparison with Intravascular Optical Coherence Tomography.

BACKGROUND/PURPOSE: This study sought to determine the diagnostic accuracy of 320-row computed tomography (320CT) for characterizing coronary atherosclerotic plaques in comparison with optical coherence tomography (OCT). METHODS/MATERIALS: From 32 patients, 42 coronary segments were evaluated and co-registered by both 320CT and OCT. 320CT vulnerable plaque characteristics included low attenuation plaque (LAP) (<30HU), napkin-ring sign (NRS), positive remodeling (PR) and spotty calcification (SC). The presence of macrophage, neovascularization and cholesterol crystals was also determined by OCT. RESULTS: Minimal lumen area was 2.78 ±â€¯1.23 mm by OCT and 3.29 ±â€¯1.49 mm by 320CT (p < 0.001). Noncalcified plaques were classified accordingly by both methods in 88.2% of the cases (p = 0.005). There was no association between any 320CT plaque type and OCT fibroatheroma (p = 0.62). The combination of 2 or more of the 320CT vulnerable plaque characteristics was associated with the presence of macrophage (74.2 vs. 25.8%; p = 0.034) and cholesterol crystals (85.7 vs. 14.3%; p = 0.04), but not with neovascularization (p = 0.65). The presence of all four characteristics demonstrated an accuracy of 75.1% for detecting OCT fibroatheroma. CONCLUSIONS: 320CT is useful for non-invasive evaluation of calcified and noncalcified tissue characteristics of coronary atheroma. The combination of all four 320CT vulnerable plaque characteristics provided the highest accuracy for detecting fibroatheromas. SUMMARY: 320CT is useful for non-invasive evaluation of calcified and noncalcified tissue characteristics of coronary atheroma. The combination of all 320CT vulnerable plaque characteristics (low attenuation plaque (<30HU), napkin-ring sign, positive remodeling and spotty calcification) provided the highest accuracy for detecting fibroatheromas compared to optical coherence tomography.

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.

Impact of Acute Kidney Injury on Short- and Long-term Outcomes After Transcatheter Aortic Valve Implantation.

INTRODUCTION AND OBJECTIVES: Acute kidney injury (AKI) is frequently observed after transcatheter aortic valve implantation (TAVI) and is associated with higher mortality. However, the impact of AKI on long-term outcomes remains controversial. Therefore, we sought to evaluate the impact of AKI on short- and long-term outcomes following TAVI using the Valve Academic Research Consortium 2 criteria. METHODS: Consecutive patients (n = 794) with severe aortic stenosis who underwent TAVI were included in a multicenter Brazilian registry. Logistic regression analysis was used to identify predictors of AKI. Four-year outcomes were determined as Kaplan-Meier survival curves, and an adjusted landmark analysis was used to test the impact of AKI on mortality among survivors at 12 months. RESULTS: The incidence of AKI after TAVI was 18%. Independent predictors of AKI were age, diabetes mellitus, major or life-threatening bleeding and valve malpositioning. Acute kidney injury was independently associated with higher risk of all-cause death (adjusted HR, 2.8; 95%CI, 2.0-3.9; P < .001) and cardiovascular mortality (adjusted HR, 2.9; 95%CI, 1.9-4.4; P < .001) over the entire follow-up period. However, when considering only survivors at 12 months, there was no difference in both clinical endpoints (adjusted HR, 1.2; 95%CI, 0.5-2.4; P = .71, and HR, 0.7; 95%CI, 0.2-2.1; P = .57, respectively). CONCLUSIONS: Acute kidney injury is a frequent complication after TAVI. Older age, diabetes, major or life-threatening bleeding, and valve malpositioning were independent predictors of AKI. Acute kidney injury is associated with worse short- and long-term outcomes. However, the major impact of AKI on mortality is limited to the first year after TAVI.

A randomized comparison of a sirolimus-eluting stent with a standard stent for coronary revascularization.

BACKGROUND: The need for repeated treatment of restenosis of a treated vessel remains the main limitation of percutaneous coronary revascularization. Because sirolimus (rapamycin) inhibits the proliferation of lymphocytes and smooth-muscle cells, we compared a sirolimus-eluting stent with a standard uncoated stent in patients with angina pectoris. METHODS: We performed a randomized, double-blind trial to compare the two types of stents for revascularization of single, primary lesions in native coronary arteries. The trial included 238 patients at 19 medical centers. The primary end point was in-stent late luminal loss (the difference between the minimal luminal diameter immediately after the procedure and the diameter at six months). Secondary end points included the percentage of in-stent stenosis of the luminal diameter and the rate of restenosis (luminal narrowing of 50 percent or more). We also analyzed a composite clinical end point consisting of death, myocardial infarction, and percutaneous or surgical revascularization at 1, 6, and 12 months. RESULTS: At six months, the degree of neointimal proliferation, manifested as the mean (+/-SD) late luminal loss, was significantly lower in the sirolimus-stent group (-0.01+/-0.33 mm) than in the standard-stent group (0.80+/-0.53 mm, P<0.001). None of the patients in the sirolimus-stent group, as compared with 26.6 percent of those in the standard-stent group, had restenosis of 50 percent or more of the luminal diameter (P<0.001). There were no episodes of stent thrombosis. During a follow-up period of up to one year, the overall rate of major cardiac events was 5.8 percent in the sirolimus-stent group and 28.8 percent in the standard-stent group (P<0.001). The difference was due entirely to a higher rate of revascularization of the target vessel in the standard-stent group. CONCLUSIONS: As compared with a standard coronary stent, a sirolimus-eluting stent shows considerable promise for the prevention of neointimal proliferation, restenosis, and associated clinical events.

Echocardiographic and hemodynamic determinants of right coronary artery flow reserve and phasic flow pattern in advanced non-ischemic cardiomyopathy.

BACKGROUND: In patients with advanced non-ischemic cardiomyopathy (NIC), right-sided cardiac disturbances has prognostic implications. Right coronary artery (RCA) flow pattern and flow reserve (CFR) are not well known in this setting. The purpose of this study was to assess, in human advanced NIC, the RCA phasic flow pattern and CFR, also under right-sided cardiac disturbances, and compare with left coronary circulation. As well as to investigate any correlation between the cardiac structural, mechanical and hemodynamic parameters with RCA phasic flow pattern or CFR. METHODS: Twenty four patients with dilated severe NIC were evaluated non-invasively, even by echocardiography, and also by cardiac catheterization, inclusive with Swan-Ganz catheter. Intracoronary Doppler (Flowire) data was obtained in RCA and left anterior descendent coronary artery (LAD) before and after adenosine. Resting RCA phasic pattern (diastolic/systolic) was compared between subgroups with and without pulmonary hypertension, and with and without right ventricular (RV) dysfunction; and also with LAD. RCA-CFR was compared with LAD, as well as in those subgroups. Pearson's correlation analysis was accomplished among echocardiographic (including LV fractional shortening, mass index, end systolic wall stress) more hemodynamic parameters with RCA phasic flow pattern or RCA-CFR. RESULTS: LV fractional shortening and end diastolic diameter were 15.3 +/- 3.5 % and 69.4 +/- 12.2 mm. Resting RCA phasic pattern had no difference comparing subgroups with vs. without pulmonary hypertension (1.45 vs. 1.29, p = NS) either with vs. without RV dysfunction (1.47 vs. 1.23, p = NS); RCA vs. LAD was 1.35 vs. 2.85 (p < 0.001). It had no significant correlation among any cardiac mechanical or hemodynamic parameter with RCA-CFR or RCA flow pattern. RCA-CFR had no difference compared with LAD (3.38 vs. 3.34, p = NS), as well as in pulmonary hypertension (3.09 vs. 3.10, p = NS) either in RV dysfunction (3.06 vs. 3.22, p = NS) subgroups. CONCLUSION: In patients with chronic advanced NIC, RCA phasic flow pattern has a mild diastolic predominance, less marked than in LAD, with no effects from pulmonary artery hypertension or RV dysfunction. There is no significant correlation between any cardiac mechanical-structural or hemodynamic parameter with RCA-CFR or RCA phasic flow pattern. RCA flow reserve is still similar to LAD, independently of those right-sided cardiac disturbances.

Assessment of long-term mortality in patients with complex coronary artery disease undergoing percutaneous intervention: comparison of multiple anatomical and clinical prognostic risk scores.

AIMS: Three-vessel and left main coronary artery disease (CAD) have important prognostic implications. Consequently, numerous risk scores have been developed to stratify patients with complex CAD. The aim of the present study was to compare the predictive performance of six risk scores for occurrence of fouryear all-cause mortality. METHODS AND RESULTS: From March 2008 to December 2012, 348 consecutive patients with complex CAD undergoing percutaneous coronary intervention (PCI) in a tertiary centre in São Paulo, Brazil, were analysed. Four-year mortality was assessed. The scores compared were: baseline SYNTAX score (SS), residual SYNTAX score (rSS), ACEF score, clinical SYNTAX score (cSS), SYNTAX revascularisation index (SRI) and SYNTAX score II (SSII). SSII had the best predictive performance, AUC 0.82, Brier score 0.10, surpassing all the other scores for long-term mortality prediction. Moreover, SSII discriminated well PCI patients in risk groups with p<0.01 for four-year all-cause mortality. The ACEF score (AUC 0.77) and the cSS (AUC 0.78) were significantly better than the SS (AUC 0.65), SRI (AUC 0.60) or the rSS (AUC 0.55). CONCLUSIONS: For patients with complex CAD treated by PCI, the combination of baseline clinical and angiographic factors provided better risk assessment. The SSII demonstrated the most precise predictive performance for long-term mortality.

Young woman with nutcracker syndrome without main clinic manifestation: Hematuria-Case report.

INTRODUCTION: The nutcracker syndrome occurs due to the compression of the left renal vein between the aorta and the superior mesenteric artery. The diagnosis of the syndrome is often difficult and under diagnosed. The main clinical manifestations are hematuria and pelvic or back pain. PRESENTATION OF CASE: A 25 years old female patient with severe abdominal pain in the lower abdomen without hematuria. Diagnosis with nutcracker syndrome after performing computed tomography. Presented the first episode of pain with 17 years old and was diagnosed at age 25. DISCUSSION: In the nutcracker syndrome anatomical changes do not generate specific symptoms, causing the disease to be underdiagnosed. In this syndrome, there is increased pressure on the left renal vein, generating several signs and symptoms, and hematuria is one of present. Our patient did not have hematuria. Because of common symptoms, it makes nutcracker syndrome difficult diagnosis, confusing with other diseases, especially with nephrolithiasis. It is usually diagnosed after exclusion of other diseases. CONCLUSION: The diagnosis of nutcracker syndrome is done after exclusion of other causes of chronic pelvic pain. In most cases, macroscopic and microscopic hematuria are present but was unobserved in this case. Making it more difficult diagnosis.

Permanent Pacing After Transcatheter Aortic Valve Implantation: Incidence, Predictors and Evolution of Left Ventricular Function.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) is a well-established procedure; however, atrioventricular block requiring permanent pacemaker implantation (PPI) is a common complication. OBJECTIVES: To determine the incidence, predictors and clinical outcomes of PPI after TAVI, focusing on how PPI affects left ventricular ejection fraction (LVEF) after TAVI. METHODS: The Brazilian Multicenter TAVI Registry included 819 patients submitted to TAVI due to severe aortic stenosis from 22 centers from January/2008 to January/2015. After exclusions, the predictors of PPI were assessed in 670 patients by use of multivariate regression. Analysis of the ROC curve was used to measure the ability of the predictors; p < 0.05 was the significance level adopted. RESULTS: Within 30 days from TAVI, 135 patients (20.1%) required PPI. Those patients were older (82.5 vs. 81.1 years; p = 0.047) and mainly of the male sex (59.3% vs 45%; p = 0.003). Hospital length of stay was longer in patients submitted to PPI (mean = 15.7 ± 25.7 vs. 11.8 ± 22.9 days; p < 0.001), but PPI affected neither all-cause death (26.7% vs. 25.6%; p = 0.80) nor cardiovascular death (14.1% vs. 14.8%; p = 0.84). By use of multivariate analysis, the previous presence of right bundle-branch block (RBBB) (OR, 6.19; 3.56-10.75; p ≤ 0.001), the use of CoreValve® prosthesis (OR, 3.16; 1.74-5.72; p ≤ 0.001) and baseline transaortic gradient > 50 mm Hg (OR, 1.86; 1.08-3.2; p = 0.025) were predictors of PPI. The estimated risk of PPI ranged from 4%, when none of those predictors was present, to 63%, in the presence of all of them. The model showed good ability to predict the need for PPI: 0.69 (95%CI: 0.64 - 0.74) in the ROC curve. The substudy of 287 echocardiograms during the 1-year follow-up showed worse LVEF course in patients submitted to PPI (p = 0.01). CONCLUSION: BRD prévio, gradiente aórtico médio > 50 mmHg e CoreValve® são preditores independentes de implante de MPD pós-TAVI. Ocorreu implante de MPD em aproximadamente 20% dos casos de TAVI, o que prolongou a internação hospitalar, mas não afetou a mortalidade. O implante de MPD afetou negativamente a FEVE pós-TAVI.

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.

[Angiographic geometric predictors of myocardial infarction are not associated with ultrasonographic markers of plaque vulnerability]. / Preditores geométricos angiográficos de infarto do miocárdio não são associados com marcadores ultra-sonográficos de vulnerabilidade da placa.

OBJECTIVE: Some angiographic geometric features of coronary lesions have recently been described as independent predictors of myocardial infarction. The purpose of this study was to correlate these geometric markers with intravascular ultrasound findings known to be associated with greater vulnerability to plaque rupture. METHODS: A total of 30 patients with stable coronary syndromes and de novo lesions (31 lesions) underwent coronary angiography and intravascular ultrasound (IVUS). For each lesion, angiographic geometric features (degree of symmetry, degree of stenosis, lesion length, and outflow angle) were correlated with the following ultrasound variables: type of plaque (soft, fibrous, mixed, or calcified), plaque burden and remodeling index. RESULTS: Mean lesion length was 9.2 +/- 4.4 mm, percent stenosis was 50.0% to 89.0% (mean 67.7 +/- 12.1%), inflow angles ranged from 8.48 degrees to 48.78 degrees (mean 24.0 +/- 11.4 degrees), outflow angles ranged from 8.30 degrees to 53.03 degrees (mean 23.8 +/- 11.7 degrees), and the symmetry index ranged from 0 to 1 (mean 0.56 +/- 0.32). On ultrasound evaluation, frequency of soft or calcified plaques, positive remodeling, and magnitude of plaque burden were not associated with any angiographic geometric feature (p > 0.05 for all analysis). CONCLUSION: Angiographic geometric features that predispose to acute occlusion do not correlate with IVUS morphologic and quantitative findings associated with plaque vulnerability.

Global Challenges and Solutions: Role of Telemedicine in ST-Elevation Myocardial Infarction Interventions.

Major disparities exist between developed and developing countries in the management of acute myocardial infarction (AMI). These pronounced differences result in significantly increased morbidity and mortality from AMI in different regions of the world. Lack of infrastructure, insurance, facilities, and skilled personnel are the major constraints. Primary percutaneous coronary intervention has revolutionized the treatment of AMI; however, its global use is limited by the listed constraints. Telemedicine provides an efficient methodology that can hugely increase access and accuracy of AMI management.

One-year clinical outcomes of patients treated with everolimus-eluting bioresorbable vascular scaffolds versus everolimus-eluting metallic stents: a propensity score comparison of patients enrolled in the ABSORB EXTEND and SPIRIT trials.

AIMS: We sought to compare the outcomes of low/moderate complexity patients treated with the Absorb BVS from the ABSORB EXTEND trial with patients treated with the XIENCE everolimus-eluting stent (EES), using propensity score (PS) matching of pooled data from the SPIRIT trials (SPIRIT II, SPIRIT III, SPIRIT IV) and the XIENCE V USA trial. METHODS AND RESULTS: ABSORB EXTEND was a prospective, single-arm, open-label clinical study in which 812 patients were enrolled at 56 sites. This study allowed the treatment of lesions ≤28 mm in length and with a reference vessel diameter of 2.0-3.8 mm (as assessed by online QCA). The propensity score was obtained by fitting a logistic regression model with the cohort indicator as the binary outcome and other variables as the predictor variables. At one-year clinical follow-up, there was no statistical difference between groups with regard to MACE (5.0% vs. 4.8%, p=0.83), target lesion failure (5.0% vs. 4.7%, p=0.74), ischaemia-driven target vessel revascularisation (2.3% vs. 3.0%, p=0.38) and device thrombosis (1.0% vs. 0.3%, p=0.11). Myocardial infarction was higher with Absorb (3.3% vs. 1.5%, p=0.02), at the expense of periprocedural CK-MB elevation. Independent predictors of MACE among patients receiving Absorb BVS were treatment of multivessel disease, insulin-dependent diabetes and performance of post-dilation. CONCLUSIONS: At one-year follow-up, propensity score-matched analysis demonstrated that the clinical safety and effectiveness of Absorb are comparable to those of XIENCE EES among non-complex patients treated with PCI.

Video densitometric assessment of aortic regurgitation after transcatheter aortic valve implantation: results from the Brazilian TAVI registry.

AIMS: We sought to examine the feasibility and reproducibility of a new video densitometric (VD) quantification of aortic regurgitation (AR) on aortography, and its long-term clinical impact. METHODS AND RESULTS: Using dedicated video densitometry software, AR after TAVI was quantified, and inter- and intra-observer reproducibility was investigated in 182 aortograms of the Brazilian TAVI registry. The aortograms were analysed using two software algorithms: 1) the quantitative regurgitation analysis (qRA) index interrogating the entire left ventricle (LV), and 2) a new method with the left ventricle outflow tract (LVOT) as a region of interest (ROI) (LVOT-AR). LVOT-AR was feasible in 64.8% vs. 29.7% of aortograms, compared with qRA index. Using the LVOT-AR, inter-observer variability was low (mean difference±standard deviation [SD]: 0.01±0.05, p=0.53), and the two observers' measurements were highly correlated (r=0.95, p<0.001). Patients with LVOT-AR >0.17 had a significantly higher one-year all-cause mortality risk compared with patients with LVOT-AR ≤0.17 (37.1% vs. 11.2%, p=0.0008). CONCLUSIONS: This study proposes an alternative methodology for AR assessment after TAVI by using the LVOT method (LVOT-AR) of VD angiography. The assessment of LVOT-AR is feasible, reproducible and potentially predictive of one-year mortality.