Neurologic complications after transradial or transfemoral approach for diagnostic and interventional cardiac catheterization: A propensity score analysis of 16,710 cases from a single centre prospective registry.

BACKGROUND AND AIM: Transradial approach (TRA) is being used increasingly as the preferential vascular access site for both diagnostic and interventional procedures. However, concerns have risen about the risk of clinically meaningful neurologic complications. We aimed to assess the association between the risk of stroke/transient ischemic attack (TIA) and the transradial (vs. transfemoral) approach. METHODS AND RESULTS: Data from 16,710 cases included in a single centre prospective registry between January 2006 and November 2012 was analyzed. Radial procedures were considered as those in which the radial access was used either primarily (n = 4,195) or after conversion (n = 36). Potential cases with neurologic events were targeted by cross-referencing patients who underwent both cardiac catheterization and cranial-computed tomography (cranial-CT) during the same admission episode (n = 67). Procedure-related events were defined as a definitive non-CABG related stroke/TIA occurring within 48 hr of the procedure. TRA increased from 0.7% in 2006 to 75% in 2012. Total incidence of stroke/TIA was 0.16% and did not change over the study period (P = 0.26). There was no significant difference in stroke/TIA rates between groups (0.165% vs. 0.160%; P = 1.0). After correction for baseline differences and propensity score matching, TRA was not an independent predictor of stroke/TIA (OR 1.21; 95% CI 0.49-2.98 and 1.3; 95% CI 0.55-3.54, respectively). Results were consistent in pre-specified sub-groups according to age (≥65 y.o. vs. younger), gender, interventional vs. diagnostic and ACS vs. stable. CONCLUSION: Rates of documented stroke/TIA were low. Our observational study suggests that widening the use of the TRA is not associated with an increased risk of clinically relevant procedure-related neurologic complications.

[Transapical aortic valve replacement: a 5-years experience]. / VÁLVULA AÓRTICA PERCUTÂNEA TRANSAPICAL: 5 ANOS DE EXPERIÊNCIA.

OBJECTIVES: Transcatheter aortic valve replacement (TAVR) by transapical approach is accepted for severe aortic stenosis in patients with high risk for conventional surgical therapy. Herein is reported the initial clinical results of this technique in a reference center METHODS: We conducted a longitudinal prospective single center study including 54 consecutive patients (mean age 79 ± 7.5 years, 59% male) who underwent, between November 2008 and October 2013, TAVR with Edwards Sapien valves throught transapical approach. The etiology was native aortic stenosis in 83% (mean gradient = 49 ± 18.3 mmHg and area = 0,7 cm2), 11% aortic disease and 3 patients had degenerated biological valvular prostheses, being 65% in class III/IV NYHA. The major comorbidities were coronary heart disease in 56% (status post-coronary surgery 37%), diabetes (37%), peripheral artery disease (31%) and chronic renal failure (24%). The logistic EuroSCORE was 19.8 ± 11.2 and EuroSCORE II 5.5 ± 3.5%, with STS mortality score 5.1 ± 3.7 and 23.7 ± 7.6 STS morbidity. RESULTS: Analysis following the VARC-2 criteria (Valve Academic Research Consortium), showed 30-day mortality of 5.6%; peri-procedural myocardial infarction 7.4%; disabling cerebral vascular accident 1.9%; severe haemorrhage 14.8%; major vascular complications 5.6%; pacemaker implantation 11%. Unplanned extracorporeal circulation was used in 5 cases and prosthetic dysfunction occurred in 4 patients (shift valve in 2 cases). The median hospital stay was 8.0 days, with re-hospitalization in 12.2% of cases. The composite VARC-2 endpoints were: device success = 90.7%; early safety at 30 days = 75.9% and clinical efficacy after 30 days= 83.7%. CONCLUSION: The transapical approach was found as an effective therapy for patients at high risk for conventional surgery.

Predictors of pacemaker implantation after TAVI in a registry including self, balloon and mechanical expandable valves.

The need for permanent pacemaker implantation (PPMI) is a burdensome complication of transcatheter aortic valve implantation (TAVI). The aim of our study was to evaluate different anatomical, clinical, electrocardiographic, and procedural variables associated with the development of conduction abnormalities after TAVI across the entire device spectrum. Single-center prospective cohort of consecutive patients who underwent TAVI since March 2017. Final cohort was studied to detect areas of calcium within aortic valve characterized by leaflet sector and region. Membranous septum (MS) length was assessed throughout a modified coronal view. Device selection and positioning were performed according to the operator criteria. Device selection and positioning were performed according to the operator criteria. From the 273 patients included, 57 underwent PPMI (20.8%). Univariate analysis determined right bundle branch block (RBBB), QRS duration, MS length and calcium within LVOT of non-coronary cuspid as independent predictors. After multivariable logistic regression, both RBBB (OR 6.138; 95% CI 1.23-30.73, P = 0.027) and MS length (OR 0.259; 95% CI 0.164-0.399, P < 0.005) emerged as statistically significant. As a model, they could predict PPMI in 88.7%, independently of which valve used. Youden index analysis yielded 7.69 mm as the optimal cut-off with a negative and positive predictive value of 94.7 and 71.9%, respectively. In our experience, both RBBB pattern and short membranous septum (< 8 mm) were strongly and independently associated with new permanent pacemaker implantation, regardless of the device type. Our findings suggest that this simple evolved measure of MS length may guide device selection and implantation technique and facilitate early discharge.

Unexpected success in early post-transplantation renal vein thrombosis: A case report and literature review.

BACKGROUND: Allograft renal vein thrombosis can cause graft loss during the early postoperative period. This diagnosis is sometimes elusive, requiring a strong suspicion. On the other hand, several authors have recognized risk factors for allograft renal vein thrombosis, but neither a preventive approach nor a treatment have been recommended for this complication. CASE PRESENTATION: We present a case report of early allograft renal vein thrombosis, preceded by femoral common deep vein thrombosis in a recipient of a third kidney transplant. Despite femoral common deep vein thrombosis treatment with low-molecular-weight heparin and progressive improvement of renal function to a nadir serum creatinine of 0.51 mg/dL, the patient experienced a sudden episode of anuria on postoperative day 5. Doppler ultrasonography strongly suggested the diagnosis of allograft renal vein thrombosis. The patient underwent balloon catheter and aspiration venous thrombectomy, followed by unfractionated heparin perfusion. After 4 days of anuria and multiple blood transfusions, when allograft nephrectomy was contemplated, diuresis suddenly resumed. After 1 year of follow-up, the patient still has a normal renal function. CONCLUSION: This case report shows successful treatment of allograft renal vein thrombosis associated with deep vein thrombosis in the first week of transplantation, using balloon catheter and aspiration venous thrombectomy followed by perfusion of unfractionated heparin. The authors suggest this technique as a treatment option for transplant renal vein thrombosis. However, they reinforce the importance of individualized treatment and they remind that a delay may jeopardize the potential benefit of the procedure.

Non-pharmacological treatment of refractory angina: The coronary sinus reducer, the new kid on the block.

Refractory angina is defined as persistent angina (≥3 months) despite optimal medical and interventional therapies. It is increasing in frequency, due to the success of current medical and interventional therapies in improving the prognosis of coronary artery disease. Long-term mortality is similar to that of patients with asymptomatic stable disease, but it affects patients' quality of life, and has a significant impact on health care resources. Several therapeutic targets have been investigated, most with disappointing results. Many of the techniques have been abandoned because of lack of efficacy, safety issues, or economic and logistic limitations to wider applicability. The primary focus of this review is the coronary sinus Reducer, supporting evidence for which, although scarce, is promising regarding safety and efficacy in improving anginal symptoms and quality of life. It is also accessible to virtually all interventional cardiology departments.

Non-pharmacological treatment of refractory angina: The coronary sinus reducer, the new kid on the block. / Tratamento não farmacológico da angina refratária. Dispositivo de redução do seio coronário, uma nova alternativa terapêutica.

Refractory angina is defined as persistent angina (≥3 months) despite optimal medical and interventional therapies. It is increasing in frequency, due to the success of current medical and interventional therapies in improving the prognosis of coronary artery disease. Long-term mortality is similar to that of patients with asymptomatic stable disease, but it affects patients' quality of life, and has a significant impact on health care resources. Several therapeutic targets have been investigated, most with disappointing results. Many of the techniques have been abandoned because of lack of efficacy, safety issues, or economic and logistic limitations to wider applicability. The primary focus of this review is the coronary sinus Reducer, supporting evidence for which, although scarce, is promising regarding safety and efficacy in improving anginal symptoms and quality of life. It is also accessible to virtually all interventional cardiology departments.

Coronary artery vasospasm and acute myocarditis: a rare association.

Coronary vasospasm is one cause of chest pain in patients with acute myocarditis. This is a rare association, with few cases reported in the literature. The authors describe a case of acute myocarditis in which presentation mimicked acute myocardial infarction. During hospitalization severe angina recurred twice, accompanied by transient ST-segment elevation in different locations. The hypothesis of coronary vasospasm is discussed. The role of cardiac magnetic resonance imaging in this context is highlighted.

Five-year clinical results of coronary angioplasty with drug-eluting stents. National initiative in strategic innovation, iNOS.

INTRODUCTION: The use of drug-eluting stents (DES) is beneficial in patients undergoing percutaneous coronary intervention (PCI) and there is particular interest in long-term follow-up. OBJECTIVE: We aimed to assess and characterize early DES use in Portugal during 2003 and patient follow-up over a 5-year period. We developed a web-based database to collect and organize patient and procedural data from PCI performed in ten cardiovascular interventional centers sharing the same database. METHODS: This was a multicenter retrospective study that included 1833 consecutive angiographically successful coronary angioplasties in which a DES was implanted in 2003. A subgroup of patients with 5-year clinical follow-up after the initial procedure was selected for which there was at least a 90% follow-up rate during one quarter of 2003. Demographic, clinical and angiographic characteristics of the entire population were assessed. In the clinical follow-up cohort, the incidence of major adverse cardiac events (MACE)--death, myocardial infarction and surgical or percutaneous target lesion revascularization--was analyzed by survival curves and logistic regression analysis. RESULTS: Of the total population, 23% were female, and mean age was 62 +/- 11 years (25-92). The main risk factors were hypertension (60.5%), dyslipidemia (42.9%), smoking (45.1%) and diabetes (23.9%, of whom 13.2% were on insulin therapy). There was a history of myocardial infarction, PCI or bypass surgery respectively in 23.1%, 25.1%, and 9.7% of the patients. Multivessel disease was present in 59.9% of patients (mean of 1.86 +/- 0.81 vessels). PCI was performed on average in 1.24 +/- 0.48 lesions, and complete revascularization in 58.8%. A total of 2058 stents were used (mean of 1.62 +/- 0.84) in 1271 patients. The longitudinal substudy included only 320 PCIs, for which follow-up was achieved in 319 (99%; median: 1875 days, P25: 1457 days, P75: 2045 days). Thirty-seven deaths (11.6%) and 61 MACE (19.1%) occurred in this group, with no differences between insulin-treated and other diabetic patients. CONCLUSION: This is the first study to analyze the early Portuguese experience with drug-eluting stents. The clinical results compare favorably with the first published international registries. The on-line platform used was successful in collecting data in a standardized format on the clinical experience of multiple centers.

Diagnostic accuracy of computed tomography angiography for the exclusion of coronary artery disease in candidates for transcatheter aortic valve implantation.

Coronary CT angiography (CTA) is currently considered a reliable method to exclude obstructive coronary artery disease (CAD) before valvular heart surgery in patients with low pretest probability. However, its role in excluding obstructive CAD before transcatheter aortic valve implantation (TAVI) is less well established. Single-center retrospective study where patients with severe symptomatic aortic stenosis underwent both CTA and invasive coronary angiography (ICA) as part of TAVI planning. CTA exams were conducted on a 64-slice dual source scanner, with a median interval of 45 days to ICA (IQR 25-75 [13-82]). In both tests, obstructive CAD was defined as a ≥50% stenosis in an epicardial vessel ≥2 mm diameter. Per-patient, per-vessel and per-proximal segment analyses were conducted, excluding and including non-evaluable segments. The study included 200 patients (120 women, mean age 83 ± 6 years). The prevalence of obstructive CAD on ICA was 35.5% (n = 71). On a per-patient analysis (assuming non-evaluable segments as stenotic), CTA showed sensitivity of 100% (95% CI, 95-100%), specificity of 42% (95% CI, 33-51%), and positive and negative predictive values of 48% (95% CI, 44-51%) and 100% (95% CI, 92-100%), respectively. CTA was able to exclude obstructive CAD in 54 patients (27%), in whom ICA could have been safely withheld. Despite the high rate of inconclusive tests, pre-procedural CTA is able to safely exclude obstructive CAD in a significant proportion of patients undergoing TAVI, possibly avoiding the need for ICA in roughly one quarter of the cases.

Impact of angiographic coronary artery disease complexity on ischemic and bleeding risks and on the comparative effectiveness of zotarolimus-eluting vs. bare-metal stents in uncertain drug-eluting stent candidates.

BACKGROUND: The impact of coronary artery disease (CAD) extension/complexity on outcomes and on the comparative benefits/risks of zotarolimus-eluting stent (ZES) versus bare-metal stents (BMS) remains unclear in patients at high risk of bleeding or thrombosis or at low restenosis risk. METHODS: We performed a post-hoc analysis of the ZEUS trial. The impact of coronary anatomic complexity measured by the SYNTAX score on the differences in outcomes following ZES and BMS was assessed at 1 year. RESULTS: The mean SYNTAX score was 16.3 ±â€¯13.1 with a median of 12 (IQR: 7 to 22). We stratified patients according to SYNTAX tertiles (0-8: n = 563; >8-19 n = 532; >19: n = 511), and observed that the higher the score, the correspondingly higher was the rate of the primary endpoint of major adverse cardiovascular events (MACE) and other ischemic events, but not bleeding after adjustment. The superior efficacy of ZES versus BMS for MACE was consistent across SYNTAX tertiles (tertile 1: HR 0.71, 95% CI 0.44-1.13; tertile 2: HR 0.71, 95% CI 0.46-1.09; tertile 3: HR 0.83, 95% CI 0.61-1.10) without significant heterogeneity (p for trend = 0.55). This between-groups difference mainly reflected a reduction in MI and TVR without effect on mortality. There was no significant interaction between the SYNTAX score and allocated stent type with respect to ischemic and bleeding endpoints. CONCLUSIONS: The SYNTAX score was predictor of major adverse cardiovascular events but not bleeding and ZES provided superior efficacy and safety than BMS across the whole spectrum of CAD complexity. SYNTAX score may be routinely used for the assessment of the ischemic risk (but not bleeding) after PCI and should not guide the decision-making for DES versus BMS in patients undergoing PCI.

Coronary Artery Bypass Grafting Versus Percutaneous Coronary Intervention in Patients With Non-ST-Elevation Myocardial Infarction and Left Main or Multivessel Coronary Disease.

Current recommendations on the optimal revascularization strategy in Non-ST-elevation myocardial infarction (NSTEMI) with left main (LM) or multivessel coronary disease (MVD) are based upon randomized clinical trials conducted in stable coronary artery disease. In a real-world contemporary observational registry, we compared the long-term outcome of NSTEMI patients with LM/MVD (n = 1,104) submitted to coronary artery bypass grafting (CABG), percutaneous coronary intervention (PCI), or optimized medical therapy (OMT). The primary end point was 5-year all-cause mortality. Results were assessed in the entire population (CABG 289, PCI 399, and OMT 416) and in a propensity score-matched cohort of CABG (n = 159) and PCI (n = 159). Crude 5-year mortality rates in CABG and PCI were 25.3% versus 29.6%, respectively (unadjusted hazard ratio [HR] 1.2; 95% confidence intervals [CI] 0.9 to 1.6; p = 0.212); OMT, however, was associated with a twofold higher risk of mortality when compared with any revascularization strategy (unadjusted HR 2.0; 95% CI 1.7 to 2.5; p < 0.001). After propensity score-matching and multivariate analysis, there was a trend toward a higher incidence of the primary end point in patients who underwent PCI versus CABG (31% vs 21%; adjusted HR 1.52; 95% CI 0.93 to 2.50; p = 0.094). This was a consistent finding over subgroups deemed clinically relevant, such as in patients with LM or proximal left anterior descending disease, SYNergy between percutaneous coronary intervention with TAXus ≥23 and left ventricle ejection fraction <40%. In conclusion, in a real-world cohort of NSTEMI patients with LM/MVD, those selected for OMT had a dire outcome. Although adjusted 5-year mortality was statistically similar between revascularization strategies, there was a trend favoring CABG, which might be the preferred option in LM, proximal LAD, SYNergy between percutaneous coronary intervention with TAXus ≥23, and left ventricle ejection fraction <40% subgroups.

Comparison of multiparametric risk scores for predicting early mortality after transcatheter aortic valve implantation.

INTRODUCTION: Surgical risk scores are widely used to identify patients at high surgical risk who may benefit from transcatheter aortic valve implantation (TAVI). A multiparametric TAVI mortality risk score based on a French registry (FRANCE-2) has recently been developed. The aim of our study was to compare the 30-day mortality prediction performance of the FRANCE-2, EuroSCORE II and STS scores. METHODS: We retrospectively studied 240 patients from a single-center prospective registry who underwent TAVI between January 2008 and December 2015. All scores were assessed for calibration and discrimination using calibration-in-the-large and ROC curve analysis, respectively. RESULTS: The observed mortality was 5.8% (n=14). The median EuroSCORE II, STS and FRANCE-2 scores were 5.0 (IQR 3.2-8.3), 5.1 (IQR 3.6-7.1) and 2.0 (IQR 1.0-3.0), respectively. Discriminative power was greater for EuroSCORE II (C-statistic 0.67) and STS (C-statistic 0.67) than for FRANCE-2 (C-statistic 0.53), but this was not statistically significant (p=0.26). All scores showed adequate calibration. CONCLUSIONS: All scores showed modest performance in early mortality prediction after TAVI. Despite being derived from a TAVI population, FRANCE-2 was no better than surgical risk scores in our population.

Advantages of a prospective multidisciplinary approach in transcatheter aortic valve implantation: Eight years of experience.

INTRODUCTION: Aortic stenosis is the most prevalent type of valvular disease in Europe. Surgical aortic valve replacement (SAVR) is the standard therapy, while transcatheter aortic valve implantation (TAVI) is an alternative in patients at unacceptably high surgical risk. Assessment by a heart team is recommended by the guidelines but there is little published evidence on this subject. The purpose of this paper is to describe the experience of a multidisciplinary TAVI program that began in 2008. METHODS: The heart team prospectively assessed 473 patients using a standardized approach. A total of 214 patients were selected for TAVI and 80 for SAVR. Demographic, clinical and procedural characteristics and long-term success rates were compared between the groups. RESULTS: TAVI patients were older than the SAVR group (median 83 vs. 81 years), and had higher surgical risk scores (median EuroSCORE II 5.3 vs. 3.6% and Society of Thoracic Surgeons score 5.1 vs. 3.1%), as did the patients under medical treatment only. These scores were unable to assess multiple comorbidities. Patients' outcomes were different between the three groups (mortality with SAVR 25% vs. TAVI 37.6% vs. conservative therapy 57.6%, p=0.001). CONCLUSIONS: The heart team program was able to select candidates appropriately for TAVI, SAVR and conservative treatment, taking into account the risk of both invasive treatments. The use of a prospective standardized heart team approach is recommended, but requires continuous monitoring to ensure effectiveness in a timely manner.

Is Bare-Metal Stent Implantation Still Justifiable in High Bleeding Risk Patients Undergoing Percutaneous Coronary Intervention?: A Pre-Specified Analysis From the ZEUS Trial.

OBJECTIVES: This study sought to investigate the ischemic and bleeding outcomes of patients fulfilling high bleeding risk (HBR) criteria who were randomized to zotarolimus-eluting Endeavor Sprint stent (E-ZES) or bare-metal stent (BMS) implantation followed by an abbreviated dual antiplatelet therapy (DAPT) duration for stable or unstable coronary artery disease. BACKGROUND: DES instead of BMS use remains controversial in HBR patients, in whom long-term DAPT poses safety concerns. METHODS: The ZEUS (Zotarolimus-Eluting Endeavor Sprint Stent in Uncertain DES Candidates) is a multinational, randomized single-blinded trial that randomized among others, in a stratified manner, 828 patients fulfilling pre-defined clinical or biochemical HBR criteria-including advanced age, indication to oral anticoagulants or other pro-hemorrhagic medications, history of bleeding and known anemia-to receive E-ZES or BMS followed by a protocol-mandated 30-day DAPT regimen. The primary endpoint of the study was the 12-month major adverse cardiovascular event rate, consisting of death, myocardial infarction, or target vessel revascularization. RESULTS: Compared with patients without, those with 1 or more HBR criteria had worse outcomes, owing to higher ischemic and bleeding risks. Among HBR patients, major adverse cardiovascular events occurred in 22.6% of the E-ZES and 29% of the BMS patients (hazard ratio: 0.75; 95% confidence interval: 0.57 to 0.98; p = 0.033), driven by lower myocardial infarction (3.5% vs. 10.4%; p < 0.001) and target vessel revascularization (5.9% vs. 11.4%; p = 0.005) rates in the E-ZES arm. The composite of definite or probable stent thrombosis was significantly reduced in E-ZES recipients, whereas bleeding events did not differ between stent groups. CONCLUSIONS: Among HBR patients with stable or unstable coronary artery disease, E-ZES implantation provides superior efficacy and safety as compared with conventional BMS. (Zotarolimus-Eluting Endeavor Sprint Stent in Uncertain DES Candidates [ZEUS]; NCT01385319).

Early versus periprocedural administration of abciximab for primary angioplasty: a pooled analysis of 6 studies.

BACKGROUND: The 2004 ACC/AHA guidelines on ST-elevation myocardial infarction state that it is reasonable to start treatment with abciximab as early as possible before primary percutaneous coronary intervention (PCI). We investigated the potential benefit of early use of abciximab by pooling data from all the available studies. METHODS: Six prospective studies were identified that had allocated 260 patients to receive early abciximab (either prehospital or soon after the patient arrived in hospital) and 342 to receive late abciximab (at the time of PCI). RESULTS: TIMI flow grade 2 or 3 was present in 42% of the early group compared with 29% in the late group (P = .001). After PCI, 59% of patients in the early group showed ST-resolution >or = 70%, compared with 41% in the late group (P = .003). The composite clinical outcomes death, new myocardial infarction, or repeat target vessel revascularization at 30 days occurred in 7.3% of the early group compared with 9.7% in the late group (odds ratio 0.73, 95% CI 0.41-1.32) and death alone occurred in 2.7% versus 4.7%, respectively (odds ratio 0.56, 95% CI 0.23-1.39). CONCLUSIONS: Early administration of abciximab improves epicardial patency (TIMI flow) before PCI and results in better myocardial tissue perfusion (ST-resolution) after the procedure. The promising effects on clinical outcomes need to be tested in larger studies.

Quality improvement in interventional cardiology: the role of risk adjustment in evaluation of health outcomes.

BACKGROUND: The use of the methodology of adjusted risk to check the calculation of the differences between patients, groups and populations, as regards outcomes, is being used more often in the era of modern interventional cardiology to validate a reliable and balanced comparison of results between institutions and to maintain uniformity of data, criteria and definitions with a view to carrying out multicenter studies in this area of medicine. In this way, the ability to determine which variables have greater predictive value for adverse events that result from percutaneous coronary intervention (PCI) is an extremely important tool for clinical decisions and for risk adjustment in each patient, when evaluating the quality of the health care given. METHODS AND RESULTS: this work took the research design of a case-control study. The data analyzed related to all patients who had undergone PCI in an interventional cardiology unit, during 2002 (567 patients). The group of cases (33) corresponds to those patients in whom a major adverse cardiac or cerebrovascular event (MACCE) occurred during the procedure or within a 30-day period. The control group (534 patients) was made up of the rest of the population that underwent a PCI but that remained free of events in the same study period. The data on the PCIs carried out was taken from the database of the interventional cardiology unit. Analysis of the data was based on a descriptive and analytical statistical treatment (SPSS 11.5) with recourse to contingency tables, the Pearson's chi-square test, the Fisher exact test, and simple and multiple logistic regression, using odds ratios (OR) as a measure of association. The level of significance was 0.05 and the confidence interval was 95%. It should be noted that in the group of variables that showed greatest predictive value of the occurrence of an MACCE we found the following: female gender (OR = 1.593), advanced age (80 years, OR = 9.460), diabetes (OR = 3.063), chronic renal failure (OR = 3.063), depressed ejection fraction (30%, OR = 8.475), priority at PCI (OR = 7.108), multivessel disease (OR = 1.683), type C lesion (OR = 2.208), acute myocardial infarction (OR = 5.045) and cardiogenic shock (OR = 28.169). CONCLUSIONS: This study allowed us to identify, characterize and grade the set of variables that presented the strongest association with major adverse events that resulted from PCIs, for the population that underwent this type of procedure in an interventional coronary unit over the course of one year. At the same time, it enabled us to characterize the procedures that were carried out during this period, and also the demographic and clinical profile of the population. Although in some of the variables the OR values found were not statistically significant in either bivariate or multivariate analysis, we should point out that these variables are comparable to most results from similar multicenter international studies carried out with large populations. This type of study is an important contribution to improving the quality of health care given and to more efficient risk management in the field of interventional cardiology.

Predictors of Conversion from Radial Into Femoral Access in Cardiac Catheterization.

BACKGROUND: Fewer bleeding complications and early ambulation make radial access a privileged route for cardiac catheterization. However, transradial (TR) approach is not always successful, requiring its conversion into femoral access. OBJECTIVES: To evaluate the rate of conversion from radial into femoral access in cardiac catheterization and to identify its predictors. METHODS: Prospective dual-center registry, including 7632 consecutive patients undergoing catheterization via the radial access between Jan/2009 and Oct/2012. We evaluated the incidence of conversion into femoral access and its predictors by logistic regression analysis. RESULTS: The patients' mean age was 66 ± 11 years, and 32% were women. A total of 2969 procedures (38.4%) were percutaneous coronary interventions (PCI), and the most used first intention arterial access was the right radial artery (97.6%). Radial access failure rate was 5.8%. Independent predictors of conversion from radial into femoral access were the use of short introducer sheaths (OR 3.047, CI: 2.380-3.902; p < 0.001), PCI (OR 1.729, CI: 1.375-2.173; p < 0.001), female sex (OR 1.569, CI: 1.234-1.996; p < 0.001), multivessel disease (OR 1.457, CI: 1.167-1.819; p = 0.001), body surface area (BSA) ≤ 1.938 (OR 1.448, CI: 1.120-1.871; p = 0.005) and age > 66 years (OR 1.354, CI: 1.088-1.684; p = 0.007). CONCLUSION: Transradial approach for cardiac catheterization has a high success rate and the need for its conversion into femoral access in this cohort was low. Female sex, older age, smaller BSA, the use of short introducer sheaths, multivessel disease and PCI were independent predictors of conversion into femoral access.

Zotarolimus-eluting versus bare-metal stents in uncertain drug-eluting stent candidates.

BACKGROUND: The use of drug-eluting stents (DES) in patients at high risk of bleeding or thrombosis has not been prospectively studied; limited data are available in patients who have a low restenosis risk. OBJECTIVES: This study sought to compare a hydrophilic polymer-based, second-generation zotarolimus-eluting stent (ZES) with a unique drug fast-release profile versus bare-metal stents (BMS) under similar durations of dual-antiplatelet therapy (DAPT). METHODS: We randomly assigned 1,606 patients with stable or unstable symptoms, and who on the basis of thrombotic bleeding or restenosis risk criteria, qualified as uncertain candidates for DES, to receive ZES or BMS. DAPT duration was on the basis of patient characteristics, rather than stent characteristics, and allowed for a personalized 1-month dual antiplatelet regimen. The primary endpoint was the risk of 1-year major adverse cardiovascular events (MACE), which included death, myocardial infarction (MI), or target vessel revascularization (TVR). RESULTS: Median DAPT duration was 32 days (interquartile range [IQR]: 30 to 180 days) and did not differ between the groups. In the ZES group, 140 patients (17.5%) reached the primary endpoint, compared with 178 patients (22.1%) in the BMS group (hazard ratio: 0.76; 95% confidence interval: 0.61 to 0.95; p = 0.011) as a result of lower MI (2.9% vs. 8.1%; p < 0.001) and TVR rates (5.9% vs.10.7%; p = 0.001) in the ZES group. Definite or probable stent thrombosis was also significantly reduced in ZES recipients (2.0% vs. 4.1%; p = 0.019). CONCLUSIONS: Compared with BMS, DES implantation using a stent with a biocompatible polymer and fast drug-eluting characteristics, combined with an abbreviated, tailored DAPT regimen, resulted in a lower risk of 1-year MACE in uncertain candidates for DES implantation. (Zotarolimus-eluting Endeavor Sprint Stent in Uncertain DES Candidates [ZEUS] Study; NCT01385319).

Percutaneous coronary intervention using a full metal jacket with drug-eluting stents: major adverse cardiac events at one year.

BACKGROUND: The clinical benefit of percutaneous coronary intervention (PCI) for long coronary lesions is unclear; furthermore, concerns have been raised about its safety. OBJECTIVES: To evaluate the predictors of major adverse cardiac events (MACE) associated with PCI using a full metal jacket (FMJ), defined as overlapping drug-eluting stents (DES) measuring >60 mm in length, for very long lesions. METHODS: We enrolled 136 consecutive patients with long coronary lesions requiring FMJ in our single-center registry. The primary endpoint included the combined occurrence of all-cause death, myocardial infarction (MI), and target vessel revascularization (TVR). Demographic, clinical, angiographic, and procedural variables were evaluated using stepwise Cox regression analysis to determine independent predictors of outcome. RESULTS: The mean length of stent per lesion was 73.2 ± 12.3 mm and the mean reference vessel diameter was 2.9 ± 0.6 mm. Angiographic success was 96.3%. Freedom from MACE was 94.9% at 30 days and 85.3% at one year. At the one-year follow-up, the all-cause mortality rate was 3.7% (1.5% cardiac deaths), the MI rate was 3.7%, and the incidence of definite or probable stent thrombosis (ST) was 2.9%. Female gender [hazard ratio (HR), 4.40; 95% confidence interval (CI), 1.81-10.66; p = 0.001) and non-right coronary artery PCI (HR, 3.49; 95%CI, 1.42-8.59; p = 0,006) were independent predictors of MACE at one year. Freedom from adverse events at one year was higher in patients with stable angina who underwent PCI (HR, 0.33; 95%CI, 0.13-0.80; p = 0.014). CONCLUSIONS: PCI using FMJ with DES for very long lesions was efficacious but associated with a high rate of ST at the one-year follow-up. However, the rate of cardiac mortality, nonprocedure-related MI, and MACE was relatively low. Target coronary vessel PCI, clinical presentation, and female gender are new contemporary clinical factors that appear to have adverse effects on the outcome of PCI using FMJ for long lesions.