Clinical outcomes after myocardial revascularization according to operator training status: cohort study of 22,697 patients undergoing percutaneous coronary intervention or coronary artery bypass graft surgery.

AIMS: Myocardial revascularization by either coronary artery bypass graft surgery (CABG) or percutaneous coronary intervention (PCI) carries the risk of serious complications. Observational data suggest that outcomes may be improved by experienced operators, but there are few studies that have analysed the relationship between mortality and primary operator grade. The aim of this study was to investigate the effect of operator grade (trainee vs. consultant) upon outcomes of revascularization procedures. METHODS AND RESULTS: This was an observational study at a tertiary cardiology centre with accredited training programmes, between 2003 and 2011. A total of 22 697 consecutive patients undergoing either CABG or PCI were included. Associations between operator grade and mortality were assessed by hazard ratios, estimated by Cox regression analyses; 6689 patients underwent CABG, whereas 16 008 underwent PCI. Trainees performed 1968 (29.4%) CABG procedures and 8502 (53.1%) PCI procedures. The proportion of procedures performed by trainees declined over time for both CABG (30.2% in 2003 vs. 26.0% in 2010) and for PCI (58.1% in 2003 vs. 44.5% in 2010). In the unadjusted Cox analysis, consultant operator grade was associated with an increased 5-year mortality after both CABG [HR: 1.26 (95% CI: 1.07-1.47)] and PCI procedures [HR: 1.34 (95% CI: 1.22-1.47)] compared with a trainee operator. However, following multiple adjustment, consultant grade was no longer associated with mortality after either procedure [CABG: HR: 1.02 (95% CI: 0.87-1.20), PCI: HR: 1.08 (95% CI: 0.98-1.20)]. CONCLUSION: There was no observed detrimental effect on patient outcomes arising from procedures undertaken by trainees working in a structured training environment compared with consultants.

Impact of a dedicated "radial lounge" for percutaneous coronary procedures on same-day discharge rates and bed utilization.

BACKGROUND: Two advantages of transradial coronary procedures are an increased potential for same-day discharge and better resource management. This study assessed the impact of a dedicated "radial lounge" (1) on the rate of same-day discharge after elective percutaneous coronary intervention (PCI) and coronary angiography and (2) on bed utilization. METHODS: We compared our unit's rates of same-day discharge in patients who underwent elective PCI or coronary angiography in the year before and in the year after the opening of a dedicated radial lounge for elective patients. RESULTS: In its first year of operation, 439 patients who underwent PCI and 1,109 patients who underwent angiography were managed in the radial lounge. Among these patients, the rate of same-day discharge was 84.7% after PCI and 97.0% after angiography. Requirement for overnight admission was significantly more common after femoral access compared with radial access for both angiography (4.1% vs 2.8%, P < .05) and PCI (20.3% vs 14.2%, P < .01). The unit's overall rate of same-day discharge increased from 2.3% to 51.2% after elective PCI (P < .0005) and from 72.7% to 84.9% after elective angiography (P < .005). An estimated 595 bed days were saved through reduced overnight admissions in elective patients. CONCLUSIONS: Our unit's overall rates of same-day discharge after elective PCI and coronary angiography increased dramatically in the year after the opening of a dedicated radial lounge. This was directly attributable to the high rates of same-day discharge in radial lounge patients. The radial lounge impacted favorably on in-patient bed capacity.

Deployment of drug-eluting stents for isolated proximal lad disease is associated with lower major adverse cardiac events and no increase in stent thrombosis when compared with bare metal stents: a 5-year observational cohort study.

BACKGROUND: Drug-eluting stents (DES) may be associated with an increased risk of late stent thrombosis (ST) compared with bare metal stents (BMS). We compared major adverse cardiac events (MACE) and long term all cause mortality in patients with isolated proximal LAD disease treated with DES or BMS. METHOD AND RESULTS: This study of 1653 patients with isolated proximal LAD disease, includes 643 treated with BMS and 1010 treated with DES. All patients received standard dual antiplatelet treatment. MACE after 5 years were less frequent in DES compared with BMS (12.1% 95% CI 9.3-14.2 versus 21.3% 95% CI: 16.9-25.1, P < 0.0001), driven largely by a decreased rate of both target vessel and lesion revascularization (TVR: 6.3%, 95% CI 4.0-7.5% versus 14.7%, 95% CI 11.0-17.3%, P < 0.0001, TLR: (5.3%, 95% CI 3.2-7.1% versus 13.2%, 95% CI 9.8.0-15.4%, P < 0.0001). There was no difference in the rate of death, myocardial infarction, or CVA. Incidence of stent thrombosis was also comparable (1.2% 95% CI: 0.6-2.6% versus 1.1% 95% CI: 0.6-2.5%, P = 0.8). Adjusted Cox analysis confirmed a decreased risk of MACE for DES compared with BMS 0.55 (95% confidence intervals 0.41-0.73) with no difference in the hazard of all cause mortality (HR: 1.04 95% CI: 0.67-1.61). CONCLUSION: When treating proximal LAD disease, use of DES was associated with a lower MACE rate than BMS, with no differences in the incidence of stent thrombosis, myocardial infarction or 5 year all cause mortality. Our data suggests that despite the adverse prognostic correlates of proximal LAD disease, DES deployment in this location is both safe and clinically more effective than BMS.

In vitro cardiovascular system emulator (bioreactor) for the simulation of normal and diseased conditions with and without mechanical circulatory support.

This article presents a new device designed to simulate in vitro flow rates, pressures, and other parameters representing normal and diseased conditions of the human cardiovascular system. Such devices are sometimes called bioreactors or "mock" simulator of cardiovascular loops (SCVLs) in literature. Most SCVLs simulate the systemic circulation only and have inherent limitations in studying the interaction of left and right sides of circulation. Those SCVLs that include both left and right sides of the circulation utilize header reservoirs simulating cycles with constant atrial pressures. The SCVL described in this article includes models for all four chambers of the heart, and the systemic and pulmonary circulation loops. Each heart chamber is accurately activated by a separate linear motor to simulate the suction and ejection stages, thus capturing important features in the perfusion waveforms. Four mechanical heart valves corresponding to mitral, pulmonary, tricuspid, and aortic are used to control the desired unidirectional flow. This SCVL can emulate different physiological and pathological conditions of the human cardiovascular system by controlling the different parameters of blood circulation through the vascular tree (mainly the resistance, compliance, and elastance of the heart chambers). In this study, four cases were simulated: healthy, congestive heart failure, left ventricular diastolic dysfunction conditions, and left ventricular dysfunction with the addition of a mechanical circulatory support (MCS) device. Hemodynamic parameters including resistance, pressure, and flow have been investigated at aortic sinus, carotid artery, and pulmonary artery, respectively. The addition of an MCS device resulted in a significant reduction in mean blood pressure and re-establishment of cardiac output. In all cases, the experimental results are compared with human physiology and numerical simulations. The results show the capability of the SCVL to replicate various physiological and pathological conditions with and without MCS.

Outcomes in patients with renal impairment undergoing percutaneous coronary intervention and implantation of the Endeavor zotarolimus-eluting stent: 1- and 2-year data from the E-Five Registry.

OBJECTIVES: Renal impairment (RI) is a predictor of poor outcomes in patients with cardiovascular disease, but its influence in the setting of percutaneous coronary intervention and zotarolimus-eluting stent (ZES) implantation has not been described. This study evaluated the impact of RI on clinical outcomes in patients participating in the E-Five Registry. BACKGROUND: E-Five was a prospective, multicenter, global registry of 8,314 patients; 2,116 patients were followed to 2 years. METHODS: Patients (excluding those who had undergone renal transplantation) were grouped according to renal function (normal function/mild RI, serum creatinine <110 µmol/L; moderate RI, 110-200 µmol/L; severe RI, >200 µmol/L) and their outcomes evaluated retrospectively. Major adverse cardiac events (MACE; i.e., death, myocardial infarction, emergency cardiac bypass surgery, or target lesion revascularization) and stent thrombosis events at 1 and 2 years were compared between groups. RESULTS: The 1-year MACE rate in patients with mild RI was 6.8%, compared with 8.9 and 18.1% in patients with moderate and severe RI (P = 0.002 across groups). At 2 years, death occurred in 16% of those with severe RI, compared with 2.0 and 4.7% in those with mild and moderate RI (P = 0.002). There was no significant difference in the rates of target lesion revascularization or target vessel failure. CONCLUSIONS: Greater severity of RI at intervention is associated with greater mortality and MACE but unchanged revascularization rates after ZES implantation.

A first-in-man study of the Reitan catheter pump for circulatory support in patients undergoing high-risk percutaneous coronary intervention.

OBJECTIVES: To investigate the safety of a novel percutaneous circulatory support device during high-risk percutaneous coronary intervention (PCI). BACKGROUND: The Reitan catheter pump (RCP) consists of a catheter-mounted pump-head with a foldable propeller and surrounding cage. Positioned in the descending aorta the pump creates a pressure gradient, reducing afterload and enhancing organ perfusion. METHODS: Ten consecutive patients requiring circulatory support underwent PCI; mean age 71 +/- 9; LVEF 34% +/- 11%; jeopardy score 8 +/- 2.3. The RCP was inserted via the femoral artery. Hemostasis was achieved using Perclose sutures. PCI was performed via the radial artery. Outcomes included in-hospital death, MI, stroke, and vascular injury. Hemoglobin (Hb), free plasma Hb (fHb), platelets, and creatinine (cre) were measured pre PCI and post RCP removal. RESULTS: The pump was inserted and operated successfully in 9/10 cases (median 79 min). Propeller rotation at 10,444 +/- 1,424 rpm maintained an aortic gradient of 9.8 +/- 2 mm Hg. Although fHb increased, there was no significant hemolysis (4.7 +/- 2.4 mg/dl pre vs. 11.9 +/- 10.5 post, P = 0.04, reference 20 mg/dl). Platelets were unchanged (pre 257 +/- 74 x 10(9) vs. 245 +/- 63, P = NS). Renal function improved (cre pre 110 +/- 27 micromol/l vs. 99 +/- 28, P = 0.004). The RCP was not used in one patient following femoral introducer sheath related aortic dissection. All PCI procedures were successful with no deaths or strokes, one MI, and no vascular complications following pump removal. CONCLUSIONS: The RCP can be used safely in high-risk PCI patients. This device may be an alternative to other percutaneous systems when substantial cardiac support is needed.

Percutaneous haemodynamic and renal support in patients presenting with decompensated heart failure: A multi-centre efficacy study using the Reitan Catheter Pump (RCP).

BACKGROUND: Worsening heart failure complicated by congestion, hypotension, and renal dysfunction is difficult to manage, increasingly common and predicts a poor outcome. Novel therapies are required to facilitate diuresis and implementation of disease-modifying interventions in preparation for hospital discharge. Accordingly, we investigated the haemodynamic and renal effects of the Reitan Catheter Pump (RCP) percutaneous support device in patients admitted with decompensated heart failure (DHF). METHODS: This was a prospective observational study of 20 patients admitted with DHF, ejection fraction < 30%, and Cardiac index (CI) < 2.1 L/min/m2 in need of inotropic/mechanical support. RESULTS: Patients underwent RCP support for a mean of 18.3 (±6.3) hours. The RCP increased CI from 1.84 L/min/m2 (±0.27), to 2.41 L/min/m2 (±0.45, p = 0.04), increased urine output (71 mL/h (±65) to 227 ml/h (±179) (p = 0.006) with a concomitant reduction in serum creatinine (188 µmol/L (±87) to 161 µmol/L (±78) (p = 0.0007). There were no clinically significant haemolysis, vascular injury, or thrombo-embolic complications. CONCLUSIONS: For patients admitted with DHF, the RCP improves cardiac index, diuresis and renal function without causing important complications.

Real-world safety and efficacy of the endeavor zotarolimus-eluting stent: early data from the E-Five Registry.

The E-Five is a prospective, nonrandomized, multicenter global registry of patients receiving the Endeavor zotarolimus-eluting stent (ZES; Medtronic Vascular, Santa Rosa, CA) for the treatment of coronary artery stenosis. All consecutive procedures were included in the registry, without any specific anatomic or clinical exclusion criteria. Since October 2005, 8,318 patients have been enrolled in the E-Five Registry at 188 hospitals in Europe, South America, Australia, New Zealand, and Asia, and 10,343 lesions have been treated. The primary end point is the rate of major adverse cardiac events (MACE) at 1 year. Of the lesions treated, 60.3% were American College of Cardiology (ACC) and American Heart Association (AHA) type B2 or C lesions, and 16.5% were bifurcation stenoses. The average lesion length was 18.50 +/- 10.60 mm, and 50.6% of the lesions were > or =16 mm long. Clinical data have been analyzed for 1,989 of the patients (23.9%) receiving the Endeavor ZES in this registry, with 30-day clinical outcomes available for 1,985 of these 1,989 patients (99.8%). The acute procedure success rate in these patients was 98.6%, comparable with procedure success rates observed in previous Endeavor ZES clinical trials. The 30-day rate of MACE in these patients was just 1.7%, comparable with 30-day rates of MACE observed in previous ENDEAVOR clinical trials. In an early analysis of a subgroup of patients enrolled in the E-Five Registry, the Endeavor ZES demonstrated encouraging acute and 30-day outcomes in a real-world population of patients who underwent single-vessel or multivessel percutaneous coronary intervention.

The Effect of Geometry on the Efficiency and Hemolysis of Centrifugal Implantable Blood Pumps.

The application of centrifugal pumps as heart assist devices imposes design limitations on the impeller geometry. Geometry and operating parameters will affect the performance and the hemocompatibility of the device. Among all the parameters affecting the hemocompatibility, pressure, rotational speed, blade numbers, angle, and width have significant impact on the blood trauma. These parameters directly (pressure, speed) and indirectly (geometry) affect the efficiency of the pump as well. This study describes the experimental investigation on geometric parameters and their effect on the performance of small centrifugal pumps suitable for Mechanical Circulatory Support (MCS) devices. Experimental and numerical techniques were implemented to analyze the performance of 15 centrifugal impellers with different characteristics. The effect of each parameter on the pump performance and hemolysis was studied by calculating the normalized index of hemolysis (NIH) and the shear stress induced in each pump. The results show five and six blades, 15-35° outlet angle, and the lowest outlet width that meets the required pressure rise are optimum values for an efficient hemocompatible pump.

Optimization of Centrifugal Pump Characteristic Dimensions for Mechanical Circulatory Support Devices.

The application of artificial mechanical pumps as heart assist devices impose power and size limitations on the pumping mechanism, and therefore requires careful optimization of pump characteristics. Typically new pumps are designed by relying on the performance of other previously designed pumps of known performance using concepts of fluid dynamic similarity. Such data are readily available for industrial pumps, which operate in Reynolds numbers region of 10. Heart assist pumps operate in Reynolds numbers of 10. There are few data available for the design of centrifugal pumps in this characteristic range. This article develops specific speed versus specific diameter graphs suitable for the design and optimization of these smaller centrifugal pumps concentrating in dimensions suitable for ventricular assist devices (VADs) and mechanical circulatory support (MCS) devices. A combination of experimental and numerical techniques was used to measure and analyze the performance of 100 optimized pumps designed for this application. The data are presented in the traditional Cordier diagram of nondimensional specific speed versus specific diameter. Using these data, nine efficient designs were selected to be manufactured and tested in different operating conditions of flow, pressure, and rotational speed. The nondimensional results presented in this article enable preliminary design of centrifugal pumps for VADs and MCS devices.

Cocoa flavanols reduce N-terminal pro-B-type natriuretic peptide in patients with chronic heart failure.

AIMS: Poor prognosis in chronic heart failure (HF) is linked to endothelial dysfunction for which there is no specific treatment currently available. Previous studies have shown reproducible improvements in endothelial function with cocoa flavanols, but the clinical benefit of this effect in chronic HF has yet to be determined. Therefore, the aim of this study was to assess the potential therapeutic value of a high dose of cocoa flavanols in patients with chronic HF, by using reductions in N-terminal pro-B-type natriuretic peptide (NT-proBNP) as an index of improved cardiac function. METHODS AND RESULTS: Thirty-two patients with chronic HF, stable on guideline-directed medical therapy, were randomized to consume 50 g/day of high-flavanol dark chocolate (HFDC; 1064 mg of flavanols/day) or low-flavanol dark chocolate (LFDC; 88 mg of flavanols/day) for 4 weeks and then crossed over to consume the alternative dark chocolate for a further 4 weeks. Twenty-four patients completed the study. After 4 weeks of HFDC, NT-proBNP (mean decrease % ± standard deviation) was significantly reduced compared with baseline (-44 ± 69%), LFDC (-33 ± 72%), and follow-up (-41 ± 77%) values. HFDC also reduced diastolic blood pressure compared with values after LFDC (-6.7 ± 10.1 mmHg). CONCLUSIONS: Reductions in blood pressure and NT-proBNP after HFDC indicate decreased vascular resistance resulting in reduced left ventricular afterload. These effects warrant further investigation in patients with chronic HF.

Drug insight: bleeding after percutaneous coronary intervention-risks, measures and impact of anticoagulant treatment options.

In Europe, the use of interventional cardiology, including percutaneous coronary intervention (PCI), is increasing rapidly. The use of anticoagulation agents in PCI procedures is essential, but despite technical improvements, a significant associated bleeding risk still exists: more than 5% of patients are estimated to require transfusion, and around a further 13% experience minor bleeding. The methods used to detect and measure blood loss following PCI, however, vary widely between institutions and clinical trials. The risk of bleeding is influenced by therapeutic options and patient-specific characteristics, such as age, anemia and previous exposure to anticoagulants. Bleeding is associated with death, and also with less severe conditions such as thrombocytopenia, anemia, and hematoma, which have major impacts on patients' welfare and length of hospital stay, and on hospital budgets. Unfractionated heparin is the most widely used anticoagulant during PCI. Heparin, antiplatelet agents and other anticoagulants, however, have limitations that make it difficult to achieve a level of anticoagulation that prevents ischemic events without promoting bleeding. The use of low-molecular-weight heparin and the addition of glycoprotein IIb/IIIa inhibitors offer improved outcomes, but safer and more effective therapeutic agents are still required. New anticoagulants, including direct thrombin inhibitors such as bivalirudin, show similar levels of efficacy to heparin plus glycoprotein IIb/IIIa inhibitors, but with fewer hemorrhagic complications, and might advance clinical practice. This review evaluates the impact of PCI-related bleeding on patients' outcomes and hospital resources, examines methods for the detection and measurement of bleeding, and appraises the therapeutic options--particularly the newer agents--available to minimize hemorrhagic complications.

Radial primary percutaneous coronary intervention is independently associated with decreased long-term mortality in high-risk ST-elevation myocardial infarction patients.

AIM: To compare long-term clinical outcomes in patients with ST-elevation myocardial infarction (STEMI) treated by primary percutaneous coronary intervention (PPCI) using radial and femoral arterial access. METHODS AND RESULTS: The present study was an observational cohort study of patients with STEMI treated consecutively with PPCI between 2004 and 2011 at a single centre. The primary end point was all-cause mortality at a median follow-up of 3 years.Among 2727 patients, 1600 (58.7%) underwent PPCI via the femoral route. The femoral group was older (64.7 vs. 61.7 years; P < 0.0001), and had higher rates of diabetes (18.6% vs. 16.0%; P < 0.0001), previous PCI (11.2 vs. 7.8%; P = 0.004), previous myocardial infarction (15.3 vs. 8.3%; P < 0.0001) and cardiogenic shock (9.8 vs. 1.3%; P < 0.0001). Bleeding complications were more frequent in the femoral group (4.7 vs. 1.2%; P < 0.0001). The 5-year death rate was significantly higher in the femoral group than in the radial group (10.4 vs. 3.0%; P < 0.0001). After adjustment for confounding variables, bleeding complications [heart rate 2.07 (95% confidence interval 1.05-4.08)] and femoral access [heart rate 1.60 (95% confidence interval 1.02-2.53)] were independent predictors of all-cause mortality. After stratification using the propensity score, excess long-term mortality in patients treated via the femoral approach was predominantly in patients with a high baseline risk of death. CONCLUSION: Patients undergoing PPCI via the femoral route are at a higher risk of adverse short-term and long-term outcomes than patients undergoing PPCI via the radial route. Patients with a high baseline risk may benefit most from radial access, and future outcome studies should focus on the most at-risk patients.

Prognostic impact of anaemia on patients with ST-elevation myocardial infarction treated by primary PCI.

AIM: The aim of this study was to investigate the effects of baseline anaemia on the outcome in patients treated by primary percutaneous coronary intervention (PPCI) for ST-elevation myocardial infarction. METHODS: This study was a retrospective cohort study of 2418 patients with ST-elevation myocardial infarction treated by PPCI between January 2004 and August 2010 at a single centre. We investigated the outcome in patients with anaemia compared with that in patients with a normal haemoglobin (Hb) level. Anaemia was defined according to the WHO definition as an Hb level less than 12 g/dl for female individuals and less than 13 g/dl for male individuals. We also calculated hazard ratios using a stratified model according to the Hb level. RESULTS: A total of 471 (19%) patients were anaemic at presentation. The anaemic cohort was older (72.2 vs. 62.4 years, P<0.0001) and had a higher incidence of diabetes (28 vs. 16%, P<0.0001), hypertension (57 vs. 43%, P=0.01), hypercholesterolaemia (48 vs. 40%, P=0.007), previous PCI (15 vs. 9%, P<0.0001), previous myocardial infarction (23 vs. 12%, P=0.002), and cardiogenic shock (12 vs. 5%, P<0.0001). Over a mean follow-up period of 3 years there was significantly higher all-cause mortality in the anaemic group compared with the normal Hb group (20.4 vs. 13.5%, P<0.0001). However, after adjustment for all variables using multivariate analysis, anaemia (on the basis of the WHO definitions) was found not to be an independent predictor of mortality or major adverse cardiac events over the follow-up period. Further, when we used a model stratified by g/dl, we found that there was an increased risk for adverse outcomes among men with low Hb levels. There appeared to be a threshold value of Hb (13 g/dl) associated with increased risk. Although a similar trend was observed among women, no significant difference was observed. CONCLUSION: Patients with anaemia undergoing PPCI are at a higher risk of an adverse outcome. Anaemia is a simple and powerful marker of poor prognosis. Although anaemia (based on the WHO definitions) does not appear to be an independent predictor of all-cause mortality or major adverse cardiac events after PPCI on multivariate analysis, there appears to be a threshold value of Hb among men, below which there is an associated increased risk for PPCI.

Contemporary analysis of incidence and outcomes of stent thrombosis presenting as ST elevation myocardial infarction in a primary percutaneous coronary intervention cohort.

There are limited data about the effectiveness of primary percutaneous coronary intervention (PPCI) for stent thrombosis treatment. We aimed to evaluate the prevalence and outcomes of PPCI in patients with ST elevation acute myocardial infarction (STEMI) due to stent thrombosis, and comparing the outcomes with patients treated for de novo coronary thrombosis. This was an observational cohort study of 2,935 patients who underwent PPCI from 2003 to 2011 with follow-up for a median of 3.0 years (interquartile range 1.2 to 4.6). The primary end point was the first major adverse cardiac event (MACE) defined as death, nonfatal myocardial infarction, stroke, or target vessel revascularization. Stent thrombosis overall accounted for 6.6% (194 of 2,935) of all STEMIs with a proportion that increased over time (3.3% in 2004 to 9.4% in 2011). A total of 34.5% were early, 30.9% late stent thrombosis, and 34.5% were very late stent thrombosis. Indications for the original intervention were elective in 27.8%, after acute coronary syndrome (non-STEMI or unstable angina) in 21.1%, and after PPCI in 51.1%. Patients with stent thrombosis had higher rates of hypertension, hypercholesterolemia, diabetes, renal dysfunction, and previous myocardial infarction or coronary artery bypass surgery compared with patients with native artery occlusion. MACE rates were higher in patients with stent thrombosis compared with patients with native artery occlusions (40.9%, 95% confidence interval [CI] 31.1 to 50.6 vs 15.1%, 95% CI 12.5 to 18.3; p <0.0001). The poor outcome of stent thrombosis was particularly associated with early and late stent thromboses. Very late stent thrombosis appears to be a relatively less serious event, with similar outcomes to native vessel thromboses (MACE very late stent thrombosis 16.5%, 95% CI 8.2 to 28.6 vs native 15.1%, 95% CI 12.5 to 18.3, p = 0.245). In conclusion, stent thrombosis accounts for an increasing proportion of STEMI and is associated with worse outcomes compared with native artery occlusion.

Influence of female sex on long-term mortality after acute coronary syndromes treated by percutaneous coronary intervention: a cohort study of 7304 patients.

AIM: Female sex has been associated with worse outcome after percutaneous coronary intervention (PCI) for acute coronary syndromes (ACS). We assessed the influence of female sex on the long-term outcome of patients undergoing PCI for ACS. This included an unadjusted analysis and a fully-adjusted multivariate analysis including a propensity score. METHODS: This was an observational cohort study involving 7304 patients who had PCI for ACS [ST-elevation myocardial infarction (STEMI), non-ST elevation (NSTE) ACS] between October 2003 and September 2010. We analysed the effect of female sex on outcome. RESULTS: The primary end point was all-cause mortality, which was obtained from the UK Office of National Statistics at a median follow-up of 3.2 years (IQR: 1.5-4.6). Women were significantly older and had higher rates of diabetes mellitus compared with men. Over long-term follow-up, mortality was significantly higher in women with ACS compared with men; as a whole [all ACS: odds ratio (OR) 1.351, P<0.001] or when analysed by ACS type (NSTE ACS: OR 1.260, P=0.009; STEMI: OR 1.625, P<0.001). However, after adjustment using multivariate analysis, female sex was not an independent predictor of mortality in any ACS group (all ACS: OR 0.978, P=0.772; NSTE ACS: OR 0.954, P=0.603; STEMI: OR 1.081, P=0.567). This observation remained after the incorporation of a propensity score into the multivariate analysis [OR 0.95, 95% confidence interval 0.82-1.10]. CONCLUSION: Women presenting with ACS were older and had more baseline comorbidities. Female sex, however, does not appear to be an independent risk factor for mortality in our cohort.

Mild chronic kidney disease is an independent predictor of long-term mortality after emergency angiography and primary percutaneous intervention in patients with ST-elevation myocardial infarction.

OBJECTIVE: Moderate renal impairment (RI) with a glomerular filtration rate (GFR) <60 ml/min/1.73 m2 is known to predict survival. The authors investigated whether mild RI with an estimated GFR of 60-89 ml/min/1.73 m2 independently predicts survival in a contemporary population with ST segment elevation myocardial infarction (STEMI). DESIGN: This is a single-centre, observational, retrospective cohort study. Patients 601 patients with STEMI who underwent emergency catheter laboratory admission met the inclusion criteria for this study. METHODS: Estimated glomerular filtration rate (eGFR) was obtained by the Modified Diet in Renal Disease equation, and preprocedure renal function was subdivided into chronic kidney disease stages. Univariate and multivariate Cox regression analyses were performed to assess which of 17 patient or procedural variables were independent risk factors for death. RESULTS: Longitudinal data were collated for 576 patients (96.3%). Median follow-up time was 2.6 years. 30-day and long-term death rates were 5.7% and 12.5%, respectively. Following multivariable analysis, mild RI with an eGFR of 60-89 ml/min/1.73 m2 was a strong independent predictor of death, compared with an eGFR ≥90 ml/min/1.73 m2 (HR 2.79, 95% CI 1.98 to 3.92, p<0.001), and increasing chronic kidney disease stage was a strong predictor of death after both 30 days and long-term follow-up. An eGFR of 60-89 ml/min/1.73 m2 had a greater independent effect on short- and long-term mortality than the presence of diabetes mellitus (HR 2.0, 95% CI 1.2 to 3.33). CONCLUSION: Mild RI (eGFR=60-89 ml/min/1.73 m2) on admission is strongly predictive of short- and long-term mortality in patients with STEMI admitted to the catheter laboratory. A redefined threshold of clinically significant impairment is now required (GFR<90 ml/min/1.73 m2).

Successful recanalization of chronic total occlusions is associated with improved long-term survival.

OBJECTIVES: This study investigated the impact of procedural success on mortality following chronic total occlusion (CTO) percutaneous coronary intervention (PCI) in a large cohort of patients in the drug-eluting stent era. BACKGROUND: Despite advances in expertise and technologies, many patients with CTO are not offered PCI. METHODS: A total of 6,996 patients underwent elective PCI for stable angina at a single center (2003 to 2010), 836 (11.9%) for CTO. All-cause mortality was obtained to 5 years (median: 3.8 years; interquartile range: 2.0 to 5.4 years) and stratified according to successful chronic total occlusion (sCTO) or unsuccessful chronic total occlusion (uCTO) recanalization. Major adverse cardiac events (MACE) included myocardial infarction (MI), urgent revascularization, stroke, or death. RESULTS: A total of 582 (69.6%) procedures were successful. Stents were implanted in 97.0% of successful procedures (mean: 2.3 ± 0.1 stents per patient, 73% drug-eluting). Prior revascularization was more frequent among uCTO patients: coronary artery bypass grafting (CABG) (16.5% vs. 7.4%; p < 0.0001), PCI (36.0% vs. 21.2%; p < 0.0001). Baseline characteristics were otherwise similar. Intraprocedural complications, including coronary dissection, were more frequent in unsuccessful cases (20.5% vs. 4.9%; p < 0.0001), but did not affect in-hospital MACE (3% vs. 2.1%; p = NS). All-cause mortality was 17.2% for uCTO and 4.5% for sCTO at 5 years (p < 0.0001). The need for CABG was reduced following sCTO (3.1% vs. 22.1%; p < 0.0001). Multivariate analysis demonstrated that procedural success was independently predictive of mortality (hazard ratio [HR]: 0.32 [95% confidence interval (CI): 0.18 to 0.58]), which persisted when incorporating a propensity score (HR: 0.28 [95% CI: 0.15 to 0.52]). CONCLUSIONS: Successful CTO PCI is associated with improved survival out to 5 years. Adoption of techniques and technologies to improve procedural success may have an impact on prognosis.

Safety and feasibility of hospital discharge 2 days following primary percutaneous intervention for ST-segment elevation myocardial infarction.

AIM: Primary percutaneous coronary intervention (PPCI) produces more effective coronary reperfusion and allows immediate risk stratification compared with fibrinolysis. We investigated the safety and feasibility of very early discharge at 2 days following PPCI in selected low-risk cases. METHODS: This was a prospective observational cohort study of 2779 patients who underwent PPCI between 2004 and 2011. Patients meeting the following criteria were deemed suitable for very early discharge; TIMI III flow, left ventricle (LF) ejection fraction >40%, and rhythmic and haemodynamic stability out to 48 h. Higher-risk patients who did not fulfil these criteria were discharged later according to physician preference. All patients were offered outpatient review by a multidisciplinary team. Endpoints included 30 day readmission rates and major adverse cardiac events (MACE) out to a median of 2.8 years (IQR range: 1.3-4.4 years). RESULTS: 1309 (49.3%) PPCI patients met very early discharge criteria, of whom 1117 (85.3%) were actually discharged at 2 days. 620 (23.4%) were discharged at 3 days, and 916 (34.5%) >3 days after admission (median 5, IQR: 4-8) days). Patients discharged at 2 days were younger, and had lower rates of diabetes, renal dysfunction, multivessel coronary artery disease, previous myocardial infarction, and previous coronary artery bypass surgery, compared with patients discharged later. 30-day readmission rates for non-MACE events were 4.8%, 4.9% and 4.6% for patients discharged 2 days, 3 days and >3 days after admission, respectively. MACE rates were lowest in patients discharged at 2 days (9.6%, 95% CI 4.7% to 16.6%) compared with patients discharged at 3 days (12.3% 95% CI 6.0% to 19.2%) and >3 days (28.6% 95% CI 22.9% to 34.7%, p<0.0001) after admission. CONCLUSIONS: Our data suggest that discharge of low-risk patients 2 days after successful PPCI is feasible and safe. Over 40% of all patients with ST-elevation myocardial infarction may be suitable for early discharge with important implications for healthcare costs.

Clinical outcomes by geographic region for patients implanted with the zotarolimus-eluting stent.

BACKGROUND: Differences between geographic regions in patient characteristics and outcomes, particularly for acute coronary syndromes, have been demonstrated in clinical trials. Clinical outcomes after percutaneous coronary interventions with the Zotarolimus-eluting stent in a real-world population were assessed over time. OBJECTIVES: The influence of geographic location on clinical outcomes with the Zotarolimus-eluting stent was assessed in 3 regions: Asia Pacific, Europe, and Latin America. METHODS: A total of 8,314 patients (6,572 Europe, 1,522 Asia Pacific, and 220 Latin America) were followed for 1 year; 2,116 of these (1,613, 316, and 187, respectively) were followed for 2 years. Patient and lesion characteristics, dual antiplatelet therapy, and clinical outcomes were compared between Latin America and the other regions. RESULTS: Patients in Latin America had the highest proportions of risk factors and prior myocardial infarction. Dual antiplatelet therapy usage rapidly declined in Latin America, from 44.9% at 6 months to 22.5% at 1 year and 7.8% at 2 years (Europe: 87.4%, 61.5%, 19.7%; Asia Pacific: 82.4%, 67.0%, 45.7%). There were no significant differences between Latin America and Europe or Asia Pacific for any outcome at either time point. The incidence of Academic Research Consortium definite and probable stent thrombosis was low (<1.2%) among all patients at 1 year and 2 years. CONCLUSION: Clinical outcomes were comparable between patients in Latin America and Europe, and Latin America and Asia Pacific, despite less favorable clinical subsets in Latin America, a higher risk profile, and markedly lower use of dual antiplatelet therapy over time.