Ruptured sinus of Valsalva aneurysm: A reversible cause of suprasystemic pulmonary hypertension.

Management of patients with congenital heart defects and associated pulmonary arterial hypertension remains a major concern. With evolving targeted drug therapies and new iterations of transcatheter devices, treatment of appropriately selected patients with severe pulmonary hypertension, classically considered inoperable, has become feasible. We report the case of a patient with concomitant ruptured right sinus of Valsalva aneurysm and ventricular septal defect, with early reversal of suprasystemic pulmonary pressures following successful percutaneous closure of ruptured sinus of Valsalva.

Updating national diagnostic reference levels for interventional cardiology and methodological aspects.

The aim of this study is to propose national diagnostic reference levels (DRL) for updating in the field of interventional cardiology and to include technical details to help plan optimization. Medical physics experts and interventional cardiologists from 14 hospitals provided patient dose indicators from coronary angiography and percutaneous coronary interventions. Information about X-ray system dose settings and image quality was also provided. The dose values from 30,024 procedures and 26 interventional laboratories were recorded. The national DRLs proposed for coronary angiography and percutaneous coronary interventions were respectively 39 and 78 Gy·cm2 for air kerma area product (PKA), 530 and 1300 mGy for air kerma at reference point (Ka,r), 6.7 and 15 min of fluoroscopy time and 760 and 1300 cine images. 36% of the KAP meters required correction factors from 10 to 35%. The dose management systems should allow these corrections to be included automatically. The dose per image in cine in reference conditions differed in a factor of 5.5. Including X-ray system dose settings in the methodology provides an insight into the differences between hospitals. The DRLs proposed for Spain in this work were similar to those proposed in the last European survey. The poor correlation between X-ray systems dose settings and patient dose indicators highlights that other factors such as operation protocols and complexity may have more impact in patient dose indicators, which allows a wide margin for optimization. Dose reduction technology together with appropriate training programs will be determinant in the future reduction of patient dose indicators.

Does Large Vessel Size Justify Use of Bare-Metal Stents in Primary Percutaneous Coronary Intervention?

BACKGROUND: Drug-eluting stents (DES) showed improved efficacy and safety compared with bare-metal stents (BMS), and international guidelines recommend their use as first line treatment. Yet, BMS are still widely used in practice, especially in large coronary vessels. We aimed to compare efficacy and safety of second-generation DES over BMS in large coronary culprit ST-segment elevated myocardial infarction lesions. METHODS: We evaluated impact of large coronary stents (maximum size ≥3.50 mm) or smaller stents (<3.50 mm), among 1498 patients with ST-segment elevated myocardial infarction undergoing primary percutaneous coronary intervention, randomly allocated to everolimus-eluting DES or to an equivalent BMS platform in the EXAMINATION trial (Clinical Evaluation of the Xience-V Stent in Acute Myocardial Infarction Trial). Clinical events up to 5 years of follow-up were evaluated. RESULTS: Large coronary stents were used in 683 patients (45.9%). At 5-year follow-up, the crude rate of the primary end point, a composite of all-cause death, any myocardial infarction, or any revascularization, was similar among patients treated with large or smaller coronary stents. The impact of DES versus BMS implantation was consistent irrespective of the stent size both for the primary end point (Pint=0.82) and other secondary ischemic end points. Within patients treated with bigger stents, DES implantation was associated to a trend toward a reduction of target lesion (hazard ratio, 0.53; 95% CI, 0.27-1.02; P=0.05) and target vessel revascularization (hazard ratio, 0.60; 95% CI, 0.34-1.03; P=0.066). CONCLUSIONS: Our results do not support the preferential use of BMS for patients with large coronary vessels. DES may warrant improved efficacy irrespective of stent size among patients undergoing primary percutaneous coronary intervention. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT00828087.

Left Atrial Appendage Occlusion as Adjunctive Therapy to Anticoagulation for Stroke Recurrence.

BACKGROUND: Stroke recurrence despite optimal oral anticoagulation (OAC) might represent a novel indication for left atrial appendage occlusion (LAAO). The heterogeneity of these patients is generally high, as the presence of valvular atrial fibrillation (VAF) is common. The aim of this study was to explore the role of LAAO as an adjunctive therapy to OAC in patients with recurrent stroke despite optimal OAC. METHODS: The study screened consecutive patients who underwent percutaneous LAAO at nine centers between 2009 and 2017. Patients with recurrent stroke despite optimal OAC were selected and those with an absolute or relative contraindication to OAC were not included in the study. RESULTS: Among 837 patients who underwent LAAO between the study period, a total of 22 (2.6%) met the inclusion criteria. There was a high percentage of VAF (38%) and 59% presented more than one cardioembolic event before LAAO. All patients underwent successful implantation of the device and no procedural major adverse events were reported. In all but 3 patients, anticoagulation was continued after LAAO. With a median clinical follow-up of 1.8 years (range, 0.7-2.8 years), only 1 stroke and 1 transient ischemic attack were reported, translating into a significant reduction of cerebrovascular events before and after LAAO (2.0 ± 1.0 events vs 0.1 ± 0.3 events; P<.01). Imaging follow-up revealed only 1 case of device thrombosis. CONCLUSIONS: LAAO as an adjunctive therapy to OAC seems to be feasible and safe in patients with previous cardioembolic events despite optimal OAC. In our series, this strategy was associated with a low rate of cerebrovascular events after LAAO.

The Tryton® dedicated bifurcation stent: Five-year clinical outcomes.

AIMS: We report the first 5 year clinical follow-up data for the Tryton® bifurcation stent. METHODS AND RESULTS: Clinical outcomes at five years were collected from 8 centres. Non-hierarchical Major Adverse Cardiovascular Events (MACE) and Major Adverse Cerebrovascular and Cardiovascular Events (MACCE) were collected. Diabetic and non-diabetic populations were compared, along with small (≤2.5 mm) vs large (>2.5 mm) side branch size. 173 patients with a follow up rate of 98% at 5 years were analysed. Non-hierarchical MACE was low at 9.8%, consisting of cardiac death of 1.2% (n = 2) and MI of 1.7% (n = 3). Target lesion revascularization (TLR) rate was 6.9% (n = 12). Non-hierarchical MACCE was also low, with major bleeding in 2.3% (n = 4) and strokes in 1.7% (n = 3) of patients. There was only 1 case (0.6%) of stent thrombosis that was definite and occurred very late (782 days). All-cause mortality was low, with 8.7% combined cardiac and non-cardiac death (n = 15). Diabetic patients had significantly higher event rates, but there was no difference in events with lesion stratification by side branch size. CONCLUSIONS: The Tryton® Side-Branch Stent has a non-hierarchical MACE of 9.8% and MACCE of 13.9% at 5 years. The TLR was 6.9% with only 1 case of stent thrombosis recorded.

Cost-effectiveness of everolimus-eluting versus bare-metal stents in ST-segment elevation myocardial infarction: An analysis from the EXAMINATION randomized controlled trial.

BACKGROUND: Use of everolimus-eluting stents (EES) has proven to be clinically effective and safe in patients with ST-segment elevation myocardial infarction but it remains unclear whether it is cost-effective compared to bare-metal stents (BMS) in the long-term. We sought to assess the cost-effectiveness of EES versus BMS based on the 5-year results of the EXAMINATION trial, from a Spanish health service perspective. METHODS: Decision analysis of the use of EES versus BMS was based on the patient-level clinical outcome data of the EXAMINATION trial. The analysis adopted a lifelong time horizon, assuming that long-term survival was independent of the initial treatment strategy after the end of follow-up. Life-expectancy, health-state utility scores and unit costs were extracted from published literature and publicly available sources. Non-parametric bootstrapping was combined with probabilistic sensitivity analysis to co-assess the impact of patient-level variation and parameter uncertainty. The main outcomes were total costs and quality-adjusted life-years. The incremental cost-effectiveness ratio was expressed as cost per quality-adjusted life-years gained. Costs and effects were discounted at 3%. RESULTS: The model predicted an average survival time in patients receiving EES and BMS of 10.52 and 10.38 undiscounted years, respectively. Over the life-long time horizon, the EES strategy was €430 more costly than BMS (€8,305 vs. €7,874), but went along with incremental gains of 0.10 quality-adjusted life-years. This resulted in an average incremental cost-effectiveness ratio over all simulations of €3,948 per quality-adjusted life-years gained and was below a willingness-to-pay threshold of €25,000 per quality-adjusted life-years gained in 86.9% of simulation runs. CONCLUSIONS: Despite higher total costs relative to BMS, EES appeared to be a cost-effective therapy for ST-segment elevation myocardial infarction patients due to their incremental effectiveness. Predicted incremental cost-effectiveness ratios were below generally acceptable threshold values.

Incidence, Predictors, and Prognostic Value of Acute Kidney Injury Among Patients Undergoing Left Atrial Appendage Closure.

OBJECTIVES: The aims of this registry were to determine the incidence, predictors, and prognostic value of periprocedural acute kidney injury (AKI) after left atrial appendage closure (LAAC). BACKGROUND: No data exist on the occurrence of AKI after LAAC. METHODS: A total of 355 patients undergoing LAAC were included in the study. AKI was defined as an absolute or a relative increase in serum creatinine of >0.3 mg/dl or ≥50%, respectively, after the procedure or the need for hemodialysis during index hospitalization. RESULTS: The incidence of AKI was 9%, and patients with worse baseline renal function were at higher risk for developing AKI (odds ratio: 1.32; 95% confidence interval [CI]: 1.09 to 1.61; p = 0.004 for each 10 ml/min decrease in glomerular filtration rate). In-hospital bleeding events occurred more frequently in the AKI group (5.3% vs. 15.6%; p = 0.037). After a median follow-up period of 18 months, patients in the AKI group had higher mortality (hazard ratio [HR]: 2.59; 95% CI: 1.36 to 4.92; p = 0.004), more embolic events (HR: 6.14; 95% CI: 2.23 to 16.92; p = 0.001) and major bleeding events (HR: 2.36; 95% CI: 0.89 to 6.24; p = 0.083). The occurrence of AKI was an independent predictor of midterm mortality (HR: 2.00; 95% CI: 1.02 to 3.91; p = 0.044). CONCLUSIONS: The occurrence of AKI was relatively frequent following LAAC, and patients with lower renal glomerular filtration rates were at high risk for developing this complication. AKI identified a group of patients with worse midterm outcomes, highlighting the importance of further preventive strategies in this population.

Role of ST-Segment Resolution in Patients With ST-Segment Elevation Myocardial Infarction Treated With Primary Percutaneous Coronary Intervention (from the 5-Year Outcomes of the EXAMINATION [Evaluation of the Xience-V Stent in Acute Myocardial Infarction] Trial).

In patients with ST-segment elevation myocardial infarction (STEMI) treated with primary percutaneous coronary intervention (pPCI), lack of ST-segment resolution (STR) is associated with poor prognosis at short- and long-term follow-up. The aim of this study was to evaluate the role of STR on very long-term outcomes in patients with STEMI treated with pPCI included in the EXAMINATION (Evaluation of the Xience-V Stent in Acute Myocardial Infarction) trial. Patients were stratified according to the presence of STR < 50% and STR < 70% at the 30-minute post-pPCI electrocardiogram. Primary end point was the patient-oriented composite endpoint (POCE) of all-cause death, any myocardial infarction, or any revascularization at 5-year follow-up. Both baseline and post-PCI 30-minute electrocardiograms were available for STR assessment in 1,351 patients. Of these patients, 228 (16.9%) and 500 (37.0%) exhibited STR < 50% and STR < 70%, respectively. At 5-year follow-up, the POCE was observed more frequently in patients with STR < 50% (hazard ratio [HR] 1.556; 95% confidence interval [CI] 1.194 to 2.027; p <0.001) and in patients with STR < 70% (HR 1.460, 95% CI 1.169 to 1.824, p <0.001) compared with patients with STR > 50% and STR ≥ 70%, respectively. In both cases, this difference was mainly driven by a significant increase in the rate of all-cause death and any revascularization. After multivariable adjustment, STR < 70%, but not STR < 50%, resulted as a 5-year independent predictor of POCE (adjusted HR 1.338, 95% CI 1.008 to 1.778, p = 0.044). In conclusion, in patients with STEMI, the evaluation of 70% STR after pPCI provides independent prognostic information at 5-year follow-up and it can be used to identify patients at high risk of very long-term cardiovascular events.

Long-term outcomes following percutaneous left atrial appendage closure in patients with atrial fibrillation and contraindications to anticoagulation.

PURPOSE: We aimed to evaluate the late clinical outcomes of percutaneous LAA closure in patients with atrial fibrillation (AF) and contraindication to oral anticoagulation. METHODS: Consecutive AF patients with contraindications to oral anticoagulation who underwent successful LAA closure between December 2008 and March 2013 at four centers were included. RESULTS: A total of 101 patients (median age 76 [IQR 69-80] years, 48% women, mean CHA2DS2-VASc 5 ± 2; HAS-BLED 4 ± 1) were included. Eighty-six (85.1%) patients received an Amplatzer Cardiac Plug/Amulet device and 15 (14.9%) patients a Watchman device. The mean follow-up period was 4 ± 1 years. During 358.6 patient-years of follow-up, 7 (6.9%) patients suffered a major stroke (2 cases per 100 person-years; expected rate: 6.2 cases per 100 person-years), and 20 (19.8%) patients experienced at least one episode of major bleeding (6.4 cases per 100 person-years; expected rate: 9.0 cases per 100 person-years). There were no cases of late adverse events related to the device. A total of 34 (33.7%) patients died during follow-up (9.5 cases per 100 person-years). Older age, male sex, low ejection fraction, and chronic kidney disease were identified as predictive factors of late mortality. CONCLUSIONS: Percutaneous LAA closure is safe and effective in the long term in patients with AF with contraindications to anticoagulation. However, a high long-term mortality rate was observed in this high-risk population. Comprehensive patient assessment prior to undergoing LAA closure should identify patients in whose comorbidities limit their overall prognosis.

Correlates of non-target vessel-related adverse events in patients with ST-segment elevation myocardial infarction: insights from five-year follow-up of the EXAMINATION trial.

AIMS: The aim of this substudy was to determine the five-year correlates of non-TV-related adverse events (AE) in STEMI patients included in the EXAMINATION trial. METHODS AND RESULTS: The EXAMINATION trial randomised 1,498 STEMI patients to bare metal or everolimus-eluting stent implantation. In this substudy, patients were analysed according to non-TV-related AE, defined as the composite of either non-TV revascularisation (non-TVR) or non-TV-related myocardial infarction (MI). At five-year follow-up, 125 patients (8.3%) exhibited 136 non-TV-related AE (124 [8.3%] non-TVR, 12 [0.8%] non-TV-related MI), accounting for 47.1% of 289 non-fatal cardiac events overall. These patients had a higher incidence of diabetes mellitus (p<0.001), arterial hypertension (p=0.032), previous MI (p=0.073), multivessel disease (p<0.001), and incomplete revascularisation (p=0.049), and a lower rate of ST-segment resolution >70% (p=0.042) as compared to the rest. At Cox analysis, previous MI (HR 1.872, 95% CI: 1.004-3.489; p=0.048), incomplete revascularisation (HR 1.746, 95% CI: 1.029-2.963; p=0.039) and diabetes (HR 1.942, 95% CI: 1.292-2.919; p=0.001) were independent correlates of non-TV-related AE. CONCLUSIONS: In STEMI patients undergoing primary percutaneous coronary intervention, previous MI, incomplete revascularisation and diabetes resulted in being independent correlates of five-year non-TV-related AE.

Impact of Body Mass Index on 5-Year Clinical Outcomes in Patients With ST-Segment Elevation Myocardial Infarction After Everolimus-Eluting or Bare-Metal Stent Implantation.

Patients with high body mass index (BMI) seem to have better outcomes after percutaneous coronary intervention than normal-weight patients. However, contrasting results have been reported on the "obesity paradox" in patients presenting with ST-elevation myocardial infarction (STEMI). The aim of our study was to investigate the impact of BMI on mortality in the population enrolled in the Evaluation of the Xience-V stent in Acute Myocardial INfArcTION (EXAMINATION) trial. The EXAMINATION trial randomized 1,498 patients with STEMI to a bare-metal stent or an everolimus-eluting stent. In this substudy patients were stratified into 3 groups according to BMI values: normal (BMI < 25 kg/m2), overweight (BMI = 25 to 29.9 kg/m2), and obese (BMI ≥ 30 kg/m2). The coprimary end points were the all-cause and cardiac deaths among the groups at the 5-year follow-up. BMI was available in 1,421 patients, divided in 401 (28.2%) normal, 702 (49.4%) overweight, and 318 (22.4%) obese. Obese patients were younger (p = 0.012) compared with the other groups, but with a worse cardiovascular risk profile. They were more frequently female (p <0.001) and with a higher rate of obesity-related co-morbidity conditions such as diabetes mellitus (p = 0.005), arterial hypertension (p <0.001), and hyperlipidemia (p = 0.001) compared with the other groups. At the 5-year follow-up, all-cause and cardiac deaths were less frequent in obese patients than in the other groups (p = 0.003 and p = 0.030, respectively). After adjustment for confounding variables, BMI was an independent predictor of all-cause death (hazard ratio 0.765, 95% confidence interval 0.599 to 0.979, p = 0.033), but not of cardiac death, without any interaction with the stent type. In conclusion, in patients with STEMI who underwent primary PCI, the long-term all-cause death rate decreased as BMI increased, confirming the obesity paradox, irrespective of the stent type.

A randomised trial of paclitaxel-eluting balloon after bare metal stent implantation vs. bare metal stent in ST-elevation myocardial infarction (the PEBSI study).

AIMS: Our aim was to assess the safety and efficacy of paclitaxel-eluting balloon (PTX-B) treatment after bare metal stent (BMS) implantation in patients undergoing primary angioplasty. METHODS AND RESULTS: After BMS implantation, patients were randomised (1:1) to treatment with a PTX-B or no PTX-B treatment (BMS group). The primary endpoint was in-stent late luminal loss (LLL) at nine-month follow-up. OCT was carried out on the first 20% of consecutive patients included in the study. Two hundred and twenty-three patients were randomised (BMS: 112, PTX-B: 111). At nine months, median LLL was 0.80 mm (interquartile range [IQR] 0.36-1.26) in the BMS group vs. 0.31 mm (IQR 0.00-0.58) in the PTX-B group, p<0.0001. Binary restenosis was significantly lower in the PTX-B group: 29.8% vs. 2.2%, p<0.0001, 95% confidence interval (CI): 3.2-54.2. Nine-month OCT showed good strut coverage in both groups but greater in the BMS group (100±0.0% vs. 99.52±1.11%, p=0.03) with very low rates of malapposed struts per lesion. One-year MACE was significantly lower in the PTX-B group (12.5% vs. 3.6%, p=0.016). CONCLUSIONS: PTX-B after successful BMS implantation resulted in less LLL and better clinical outcomes as compared with a BMS-only strategy. This was associated with good stent strut coverage and very low rates of malapposed struts.

Everolimus-Eluting Stents in Patients With Bare-Metal and Drug-Eluting In-Stent Restenosis: Results From a Patient-Level Pooled Analysis of the RIBS IV and V Trials.

BACKGROUND: Treatment of patients with drug-eluting stent (DES) in-stent restenosis (ISR) is more challenging than that of patients with bare-metal stent ISR. However, the results of everolimus-eluting stents (EES) in these distinct scenarios remain unsettled. METHODS AND RESULTS: A pooled analysis of the RIBS IV (Restenosis Intra-Stent of Drug-Eluting Stents: Paclitaxel-Eluting Balloon vs Everolimus-Eluting Stent) and RIBS V (Restenosis Intra-Stent of Bare Metal Stents: Paclitaxel-Eluting Balloon vs Everolimus-Eluting Stent) randomized trials was performed using patient-level data to compare the efficacy of EES in bare-metal stent ISR and DES-ISR. Inclusion and exclusion criteria were identical in both trials. Results of 94 patients treated with EES for bare-metal stent ISR were compared with those of 155 patients treated with EES for DES-ISR. Baseline characteristics were more adverse in patients with DES-ISR, although they presented later and more frequently with a focal pattern. After intervention, minimal lumen diameter (2.22±0.5 versus 2.38±0.5 mm, P=0.01) was smaller in the DES-ISR group. Late angiographic findings (89.3% of eligible patients), including minimal lumen diameter (2.03±0.7 versus 2.36±0.6 mm, P<0.001) and diameter stenosis (23±22 versus 13±17%, P<0.001) were poorer in patients with DES-ISR. Results were consistent in the in-segment and in-lesion analyses. On multiple linear regression analysis, minimal lumen diameter at follow-up remained significantly smaller in patients with DES-ISR. Finally, at 1-year clinical follow-up (100% of patients), mortality (2.6 versus 0%, P<0.01) and need for target vessel revascularization (8 versus 2%, P=0.03) were higher in the DES-ISR group. CONCLUSIONS: This patient-level pooled analysis of the RIBS IV and RIBS V randomized clinical trials suggests that EES provide favorable outcomes in patients with ISR. However, the results of EES are less satisfactory in patients with DES-ISR than in those with bare-metal stent ISR. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifiers: NCT01239953 and NCT01239940.

Long-Term Results of Everolimus-Eluting Stents Versus Drug-Eluting Balloons in Patients With Bare-Metal In-Stent Restenosis: 3-Year Follow-Up of the RIBS V Clinical Trial.

OBJECTIVES: The aim of this study was to compare the long-term efficacy of everolimus-eluting stents (EES) and drug-eluting balloons (DEB) in patients with bare-metal stent in-stent restenosis (ISR). BACKGROUND: The relative long-term clinical efficacy of current therapeutic modalities in patients with ISR remains unknown. METHODS: The 3-year clinical follow-up (pre-specified endpoint) of patients included in the RIBS V (Restenosis Intra-Stent of Bare-Metal Stents: Drug-Eluting Balloon vs Everolimus-Eluting Stent Implantation) randomized clinical trial was analyzed. All patients were followed yearly using a pre-defined structured questionnaire. RESULTS: A total of 189 patients with bare-metal stent ISR were allocated to either EES (n = 94) or DEB (n = 95). Clinical follow-up at 1, 2, and 3 years was obtained in all patients (100%). Compared with patients treated with DEB, those treated with EES obtained better angiographic results, including larger minimal luminal diameter at follow-up (primary study endpoint; 2.36 ± 0.6 mm vs. 2.01 ± 0.6 mm; p < 0.001). At 3 years, the rates of cardiac death (2% vs. 1%), myocardial infarction (4% vs. 5%) and target vessel revascularization (9% vs. 5%) were similar in the DEB and EES arms. Importantly, however, at 3 years, the rate of target lesion revascularization was significantly lower in the EES arm (2% vs. 8%; p = 0.04; hazard ratio: 0.23; 95% confidence interval: 0.06 to 0.93). The need for "late" (>1 year) target vessel (3 [3.2%] vs. 3 [3.2%]; p = 0.95) and target lesion (1 [1%] vs. 2 [2.1%]; p = 0.54) revascularization was low and similar in the 2 arms. Rates of definite or probable stent thrombosis (1% vs. 0%) were also similar in the 2 arms. CONCLUSIONS: The 3-year clinical follow-up of the RIBS V clinical trial confirms the sustained safety and efficacy of EES and DEB in patients treated for bare-metal stent ISR. In this setting, EES reduce the need for target lesion revascularization at very long-term follow-up. (RIBS V [Restenosis Intra-Stent of Bare Metal Stents: Paclitaxel-Eluting Balloon vs Everolimus-Eluting Stent] [RIBS V]; NCT01239953).

Clinical outcomes in patients with ST-segment elevation myocardial infarction treated with everolimus-eluting stents versus bare-metal stents (EXAMINATION): 5-year results of a randomised trial.

BACKGROUND: Data for the safety and efficacy of new-generation drug-eluting stents at long-term follow-up, and specifically in patients with ST-segment elevation myocardial infarction, are scarce. In the EXAMINATION trial, we compared everolimus-eluting stents (EES) with bare-metal stents (BMS) in an all-comer population with ST-segment elevation myocardial infarction. In this study, we assessed the 5-year outcomes of the population in the EXAMINATION trial. METHODS: In the multicentre EXAMINATION trial, done in Italy, Spain, and the Netherlands, patients with ST-segment elevation myocardial infarction were randomly assigned in a 1:1 ratio to receive EES or BMS. The random allocation schedule was computer-generated and central randomisation (by telephone) was used to allocate patients in blocks of four or six, stratified by centre. Patients were masked to treatment assignment. At 5 years, we assessed the combined patient-oriented outcome of all-cause death, any myocardial infarction, or any revascularisation. Analysis was by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00828087. FINDINGS: 1498 patients were randomly assigned to receive either EES (n=751) or BMS (n=747). At 5 years, complete clinical follow-up data were obtained for 731 patients treated with EES and 727 treated with BMS (97% of both groups). The patient-oriented endpoint occurred in 159 (21%) patients in the EES group versus 192 (26%) in the BMS group (hazard ratio 0·80, 95% CI 0·65-0·98; p=0·033). This difference was mainly driven by a reduced rate of all-cause mortality (65 [9%] vs 88 [12%]; 0·72, 0·52-0·10; p=0·047). INTERPRETATION: Our findings should be taken as a point of reference for the assessment of new bioresorbable polymer-based metallic stents or bioresorbable scaffolds in patients with ST-segment elevation myocardial infarction. FUNDING: Spanish Heart Foundation.

Relationship between Urinary Level of Phytate and Valvular Calcification in an Elderly Population: A Cross-Sectional Study.

Pathological calcification generally consists of the formation of solid deposits of hydroxyapatite (calcium phosphate) in soft tissues. Supersaturation is the thermodynamic driving force for crystallization, so it is believed that higher blood levels of calcium and phosphate increase the risk of cardiovascular calcification. However several factors can promote or inhibit the natural process of pathological calcification. This cross-sectional study evaluated the relationship between physiological levels of urinary phytate and heart valve calcification in a population of elderly out subjects. A population of 188 elderly subjects (mean age: 68 years) was studied. Valve calcification was measured by echocardiography. Phytate determination was performed from a urine sample and data on blood chemistry, end-systolic volume, concomitant diseases, cardiovascular risk factors, medication usage and food were obtained. The study population was classified in three tertiles according to level of urinary phytate: low (<0.610 µM), intermediate (0.61-1.21 µM), and high (>1.21 µM). Subjects with higher levels of urinary phytate had less mitral annulus calcification and were less likely to have diabetes and hypercholesterolemia. In the multivariate analysis, age, serum phosphorous, leukocytes total count and urinary phytate excretion appeared as independent factors predictive of presence of mitral annulus calcification. There was an inverse correlation between urinary phytate content and mitral annulus calcification in our population of elderly out subjects. These results suggest that consumption of phytate-rich foods may help to prevent cardiovascular calcification evolution.

Right atrial thrombosis associated with hemodialysis catheter: first description of recurrence in a poorly understood problem.

Catheter-related right atrial thrombosis (CRAT) is an underreported and potentially life-threatening complication of central venous catheter in hemodialysis patients. The accurate incidence is unknown, with reported rates ranging from 2 to 12.8% [1] in series, up to 29% [2] in a postmortem prospective study, and high mortality rates (18%) [1]. The optimal treatment for CRAT is controversial and nonsystematized, including anticoagulation, thrombolysis, and surgical thrombectomy. We report two cases of CRAT in dialysis patients, who underwent surgical thrombectomy. One case required reintervention because of recurrence, a first reported case in hemodialysis population.

Recurrent syncope after left atrial appendage occlusion.

We present the case of a 72-year-old woman with permanent atrial fibrillation and contraindication to long-term oral anticoagulant therapy who underwent left atrial appendage (LAA) occlusion. A 24-mm Amplatzer Cardiac Plug (St Jude Medical) device was deployed. The inferior part of the external disc of the device appeared to be over the posterior leaflet of the mitral valve but no significant mitral stenosis or mitral regurgitation was detected before deployment. After the procedure the patient suffered several syncopes when she tried to stand up. A transesophageal echocardiography (TEE) was performed and no significant differences on the device position were detected, it was not possible to perform the TEE in a stand-up position due to the patient symptoms (hypotension, tachycardia, dizziness, and loss of consciousness). After discussion with the surgical team, surgical removal of the device and surgical exclusion of LAA was performed. The symptoms disappeared and the patient was discharged. In the best of our knowledge, this is the first time that recurrent syncope has been described as a complication of LAA occlusion.