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Objective: To evaluate the impact of COVID-19 pandemic migitation measures on of ST-elevation myocardial infarction (STEMI) care., Background: We previously reported a 38% decline in cardiac catheterization activations during the early phase of the COVID-19 pandemic mitigation measures. This study extends our early observations using a larger sample of STEMI programs representative of different US regions with the inclusion of more contemporary data., Methods: Data from 18 hospitals or healthcare systems in the US from January 2019 to April 2020 were collecting including number activations for STEMI, the number of activations leading to angiography and primary percutaneous coronary intervention (PPCI), and average door to balloon (D2B) times. Two periods, January 2019-February 2020 and March-April 2020, were defined to represent periods before (BC) and after (AC) initiation of pandemic mitigation measures, respectively. A generalized estimating equations approach was used to estimate the change in response variables at AC from BC., Results: Compared to BC, the AC period was characterized by a marked reduction in the number of activations for STEMI (29%, 95% CI:18-38, p < .001), number of activations leading to angiography (34%, 95% CI: 12-50, p = .005) and number of activations leading to PPCI (20%, 95% CI: 11-27, p < .001). A decline in STEMI activations drove the reductions in angiography and PPCI volumes. Relative to BC, the D2B times in the AC period increased on average by 20%, 95%CI (-0.2 to 44, p = .05)., Conclusions: The COVID-19 Pandemic has adversely affected many aspects of STEMI care, including timely access to the cardiac catheterization laboratory for PPCI., (© 2020 Wiley Periodicals LLC.)

Early use of β blockers (BBs) in acute myocardial infarction remains controversial, with some studies demonstrating benefit and others harm. The aim of this study was to assess the association between pre-percutaneous coronary intervention (PCI) BB use and in-hospital outcomes in patients who underwent primary PCI for ST-segment elevation myocardial infarction between 2007 and 2009 at institutions participating in the Blue Cross Blue Shield of Michigan Cardiovascular Consortium (BMC-2). Inverse propensity score weighting was used to account for the nonrandomized use of pre-PCI BBs. The cohort comprised 7,667 patients, with 4,769 (62%) receiving pre-PCI BBs. These patients were older, with higher rates of diabetes mellitus, hypertension, and previous myocardial infarction, PCI, or coronary artery bypass grafting. In adjusted models, pre-PCI BB use was associated with lower rates of intraprocedural ventricular tachycardia or ventricular fibrillation (odds ratio [OR] 0.58, p <0.01) and lower in-hospital mortality (OR 0.65, p = 0.022), with increases in rates of emergent coronary artery bypass grafting (OR 1.56, p <0.01) and repeat PCI (OR 1.93, p <0.01). There were no significant increases in rates of cardiogenic shock and congestive heart failure. In conclusion, pre-PCI BB use in this population was associated with decreased arrhythmia and mortality, without increasing rates of cardiogenic shock and heart failure but with higher rates of repeat PCI and emergent coronary artery bypass grafting, suggesting that there may yet remain a role for early BB use in pre-PCI patients with ST-segment elevation myocardial infarctions., (Copyright © 2013 Elsevier Inc. All rights reserved.)

Background: In patients with acute ST-elevation myocardial infarction (STEMI) needing early coronary artery bypass graft (CABG) surgery, it is unknown whether primary percutaneous balloon angioplasty (PTCA)-without stent implantation-allows safe transition to subsequent CABG., Methods: We examined acute STEMI patients enrolled in the Stent-PAMI and CADILLAC trials to study the differences in the early clinical events between those treated with primary PTCA (n = 1494) or primary stenting (n = 1488)., Results: Baseline clinical and pre- and post-procedural angiographic features including post-intervention TIMI 3 flow rates were similar in the 2 groups with the exception of higher median infarct-artery residual stenosis in the PTCA group (26% [IQR 19%-34%] vs. 18% [IQR 11-25%], P < .001]. Provisional stenting was required in 16% of patients in PTCA group, while stents could not be implanted in 2% of the stent group. Sixty-percent of PTCA patients had stent-like balloon result. The rate of 30-day ischemia-driven target vessel revascularization was higher in the PTCA group (4.3% vs. 2.0%, P < .001 [4.6% vs 2.3%, P < .001 among patients with multivessel disease and 3.4% vs. 2.0%, P = .044 in patients with stent-like balloon results]) while 30-day major adverse cardiac events (6.2% vs 4.9%), death (1.8% versus 2.8%), and reinfarction (0.9% vs. 0.7%) were similar in the 2 groups., Conclusions: Compared with primary stenting, primary PTCA of infarct artery in STEMI patients was associated with significant increase in ischemia-driven target vessel revascularization (ITVR) rate, yet with no increased risk of major adverse cardiac events, reinfarction or death. Thus, provided close surveillance is maintained and prompt treatment initiated for early ischemic events, PTCA (particularly in those with stent-like balloon result) may be a reasonable and safe option in STEMI patients needing early CABG., (Copyright © 2013 Mosby, Inc. All rights reserved.)

Background: The traditional definition of contrast-induced nephropathy (CIN) has been an absolute rise of serum creatinine (Cr) of ≥0.5 mg/dL, although most recent clinical trials have included a ≥25% increase from baseline Cr. The clinical implication of this definition change remains unknown., Methods and Results: We compared the association of the two definitions with risk of death or need for dialysis among 58,957 patients undergoing percutaneous coronary intervention in 2007 to 2008 in a large collaborative registry. Patients with a preexisting history of renal failure requiring dialysis were excluded. Contrast-induced nephropathy as defined by a rise in Cr ≥0.5 mg/dL (CIN(Traditional)) developed in 1,601, whereas CIN defined either as Cr ≥0.5 mg/dL or ≥25% increase in baseline Cr (CIN(New)) developed in 4,308 patients. Patients meeting the definition of CIN(New) but not CIN(Traditional) were classified as CIN(Incremental) (n = 2,707). Compared with CIN(New), CIN(Traditional) was more commonly seen in patients with abnormal renal function, which was more likely to develop in patients with normal renal function at baseline. Compared with CIN(Incremental), patients meeting the definition of CIN(Traditional) were more likely to die (16.7% vs 1.7%) and require in-hospital dialysis (9.8% vs 0%)., Conclusions: Our data suggest that the traditional definition of CIN (a rise in Cr of ≥0.5 mg/dL) in patients undergoing PCI is superior to ≥25% increase in Cr at identifying patients at greater risk for adverse renal and cardiac events., (Copyright © 2012 Mosby, Inc. All rights reserved.)

Lipid core plaque (LCP) can extend beyond the angiographic margins of a target lesion, potentially resulting in incomplete lesion coverage. We sought to compare the target lesion length using near-infrared spectroscopy (NIRS) combined with conventional coronary angiography versus angiography alone. NIRS was performed in 69 patients (75 lesions) undergoing native vessel percutaneous coronary intervention (LipiScan Coronary Imaging System). Chemograms were analyzed for the presence and location of LCP, either within or extending beyond, the angiographic margins of the target lesion. The target lesion length was measured by quantitative coronary angiography (QCA) and compared to the lesion length measured using QCA and NIRS. LCP was present in 50 target lesions (67%). In 42 lesions (84%), LCP was present only within the target lesion. In 8 lesions (16%) LCP extended beyond the angiographic margins of the lesion. Of these 8 lesions, 4 (8%) had LCP ≤5 mm from the margins, and 4 lesions (8%) had LCP >5 mm from the angiographic margins. The mean distance that the LCP extended beyond the angiographic lesion margin was 7 ± 4 mm (range 2 to 14). For these 8 lesions, the target lesion length with NIRS plus QCA was 28 ± 10 mm versus 21 ± 8 mm with QCA alone. In conclusion, patients undergoing coronary artery stenting could have LCP extending beyond the intended treatment margins as defined using QCA alone. This could have implications for stent length selection and optimal lesion coverage., (Copyright © 2012. Published by Elsevier Inc.)

Objectives: The aim of this study was to evaluate the association between calculated creatinine clearance (CCC)-based contrast dose and renal complications in patients undergoing percutaneous coronary interventions (PCI)., Background: Excess volumes of contrast media are associated with renal complications in patients undergoing cardiac procedures. Because contrast media are excreted by the kidney, we hypothesized that a dose estimation on the basis of CCC would provide a simple strategy to define a safe dose of contrast media., Methods: We assessed the association between CCC-based contrast dose and the risk of contrast-induced nephropathy (CIN) and need for in-hospital dialysis in 58,957 patients undergoing PCI and enrolled in the BMC2 (Blue Cross Blue Shield of Michigan Cardiovascular Consortium) registry from 2007 to 2008. Patients receiving dialysis at the time of the procedure were excluded., Results: The risk of CIN and nephropathy requiring dialysis (NRD) was directly associated with increasing contrast volume adjusted for renal function. The risk for CIN and NRD approached significance when the ratio of contrast dose/CCC exceeded 2 (adjusted odds ratio [OR] for CIN: 1.16, 95% confidence interval [CI]: 0.98 to 1.37, adjusted OR for NRD: 1.72, 95% CI: 0.9 to 3.27) and was dramatically elevated in patients exceeding a contrast to CCC ratio of 3 (adjusted OR for CIN: 1.46, 95% CI: 1.27 to 1.66, adjusted OR for NRD: 1.89, 95% CI: 1.21 to 2.94)., Conclusions: Our study supports the need for minimizing contrast dose in patients with renal dysfunction. A contrast dose on the basis of estimated renal function with a planned contrast volume restricted to less than thrice and preferably twice the CCC might be valuable in reducing the risk of CIN and NRD., (Copyright © 2011 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: historically, women with ST elevation myocardial infarction (STEMI) have had a higher mortality compared with men. It is unclear if these differences persist among patients undergoing contemporary primary percutaneous coronary intervention (PCI) with focus on early reperfusion., Methods: we assessed the impact of sex on the outcome of 8,771 patients with acute STEMI who underwent primary PCI from 2003 to 2008 at 32 hospitals participating in the Blue Cross Blue Shield of Michigan Cardiovascular Consortium PCI registry. A propensity-matched analysis was performed to adjust for differences in baseline characteristics and comorbidities between men and women., Results: twenty-nine percent of the cohort was female. Compared with men, women were older and had more comorbidity. Female sex was associated with a higher unadjusted in-hospital mortality (6.02% vs 3.45%, odds ratio [OR] 1.79, 95% CI 1.45-2.22, P < .0001) and higher risk of contrast-induced nephropathy (OR 1.75, P < .0001), vascular complications (OR 2.13, P < .0001), and postprocedure transfusion (OR 2.84, P < .0001). The gap in sex-specific mortality narrowed over time. In a propensity-matched analysis, female sex was associated with a higher rate of transfusion (OR 1.88, 95% CI 1.57-2.24, P < .0001) and vascular complications (OR 1.65, 95% CI 1.26-2.14, P < .0002); but there was no difference in mortality (OR 1.30, 95% CI 0.98-1.72, P = .07)., Conclusions: women make up approximately one third of patients undergoing primary PCI for STEMI. Female sex is associated with an apparent hazard of increased mortality among patients undergoing primary PCI for STEMI, but this difference is likely explained by older age and worse baseline comorbidities among women.

Objectives: We sought to evaluate the safety and feasibility of the Impella 2.5 system (Abiomed Inc., Danvers, Massachusetts) in patients undergoing high-risk percutaneous coronary intervention (PCI)., Background: The Impella 2.5 is a miniaturized percutaneous cardiac assist device, which provides up to 2.5 l/min forward flow from the left ventricle into the systemic circulation., Methods: In a prospective, multicenter study, 20 patients underwent high-risk PCI with minimally invasive circulatory support employing the Impella 2.5 system. All patients had poor left ventricular function (ejection fraction 10 min)., Results: The Impella 2.5 device was implanted successfully in all patients. The mean duration of circulatory support was 1.7 +/- 0.6 h (range: 0.4 to 2.5 h). Mean pump flow during PCI was 2.2 +/- 0.3 l/min. At 30 days, the incidence of major adverse cardiac events was 20% (2 patients had a periprocedural myocardial infarction; 2 patients died at days 12 and 14). There was no evidence of aortic valve injury, cardiac perforation, or limb ischemia. Two patients (10%) developed mild, transient hemolysis without clinical sequelae. None of the patients developed hemodynamic compromise during PCI., Conclusions: The Impella 2.5 system is safe, easy to implant, and provides excellent hemodynamic support during high-risk PCI. (The PROTECT I Trial; NCT00534859).

Objective: The purpose of this meta-analysis was to compare outcomes for AngioJet thrombectomy versus percutaneous coronary intervention (PCI) without thrombectomy in acute myocardial infarction (AMI) patients., Background: PCI is the preferred treatment for revascularizing the infarct-related artery in patients with AMI. There is controversy about the benefits of thrombectomy as an adjunct to PCI., Methods: AMI studies published between January 1, 1999, and March 1, 2007, were used to compare AngioJet thrombectomy plus PCI to PCI alone. Bayesian meta-analytic estimates were used to estimate the odds ratios (95% CI) for short-term mortality, major adverse cardiac events (MACE), and final TIMI 3 flow., Results: The AngioJet data included 11 studies and 1,018 patients. The PCI data included 81 studies and 24,076 patients. The AngioJet group included more patients with large thrombus burden, rescue PCI after failed thrombolytic therapy, and longer symptom duration compared to the PCI group. Despite the higher risk profile of AngioJet patients, the groups had similar odds of short-term mortality, 0.98 (0.53, 1.50), MACE, 1.25 (0.54, 2.40), and final TIMI 3 flow, 1.12 (0.70, 2.27)., Conclusion: AngioJet thrombectomy results in clinical and angiographic outcomes that are similar to PCI in lower risk AMI patients. These observations suggest that AngioJet thrombectomy may reduce the additional risk associated with visible thrombus in the infarct-related lesion.

Proteinuria was associated with cardiovascular events and mortality in community-based cohorts. The association of proteinuria with mortality and cardiovascular events in patients undergoing percutaneous coronary intervention (PCI) was unknown. The association of urinary dipstick proteinuria with mortality and cardiovascular events (composite of death, myocardial infarction, or nonhemorrhagic stroke) in 5,835 subjects of the EXCITE trial was evaluated. Dipstick urinalysis was performed before PCI, and proteinuria was defined as trace or greater. Subjects were followed up for 210 days/7 months after enrollment for the occurrence of events. Multivariate Cox regression analysis evaluated the independent association of proteinuria with each outcome. Mean age was 59 years, 21% were women, 18% had diabetes mellitus, and mean estimated glomerular filtration rate was 90 ml/min/1.73 m(2). Proteinuria was present in 750 patients (13%). During follow-up, 22 subjects (2.9%) with proteinuria and 54 subjects (1.1%) without proteinuria died (adjusted hazard ratio 2.83, 95% confidence interval [CI] 1.65 to 4.84, p <0.001). The severity of proteinuria attenuated the strength of the association with mortality after PCI (low-grade proteinuria, hazard ratio 2.67, 95% CI 1.50 to 4.75; high-grade proteinuria, hazard ratio 3.76, 95% CI 1.24 to 11.37). No significant association was present for cardiovascular events during the relatively short follow-up, but high-grade proteinuria tended toward increased risk of cardiovascular events (hazard ratio 1.45, 95% CI 0.81 to 2.61).In conclusion, proteinuria was strongly and independently associated with mortality in patients undergoing PCI. These data suggest that such a relatively simple and clinically easy to use tool as urinary dipstick may be useful to identify and treat patients at high risk of mortality at the time of PCI.

Objectives: The purpose of this study was to evaluate the incidence, mechanisms, and in-hospital outcomes after failed percutaneous coronary intervention (PCI)., Background: The most common causes of PCI failure are severe dissection, no-reflow, and uncrossable total occlusions., Methods: Demographic, clinical, procedural, and quality assurance data were recorded in a prospective database to determine the incidence and outcome of failed PCI. Data were analyzed according to the year of PCI: prestent era (PSE 1993-1995), first generation stent era (FGSE 1996-2000), and contemporary stent era (CSE 2000-2003)., Results: PCI (20,884) were performed over a 10-year-period from 1993 through 2003, including 4,344 (20.8%) in the PSE, 9,114 (43.6%) in the FGSE, and 7,426 (35.6%) in the CSE; 19,171 (91.8%) were successful and 1,704 (8.2%) were failures. Nearly 90% of PCI failures are due to no-reflow or uncrossable total occlusions. Among PCI failures, 7.5% were treated medically and 0.7% required emergency coronary artery bypass grafting (ECABG). PCI success was independently associated with PCI during CSE (OR 1.86, P < 0.0001). ECABG decreased sixfold from 1.2% in the PSE to 0.2% in the CSE., Conclusions: Contemporary PCI patients have better procedural outcomes and fewer in-hospital adverse events than patient treated before the availability of stents. However, recanalization of total occlusions and avoiding no-reflow will have the most impact on future PCI success., (Copyright 2008 Wiley-Liss, Inc.)

Determinates of infarct size in patients with acute myocardial infarction (AMI) undergoing percutaneous coronary intervention (PCI) have been incompletely characterized, in part because of the limited sample size of previous studies. Databases therefore were pooled from 4 contemporary trials of primary or rescue PCI (EMERALD, COOL-MI, AMIHOT, and ICE-IT), in which the primary end point was infarct size assessed using technetium-99m sestamibi single-photon emission computed tomographic imaging, measured at the same core laboratory. Of 1,355 patients, infarct size was determined using technetium-99m sestamibi imaging in 1,199 patients (88.5%), at a mean time of 23 +/- 15 days. Median infarct size of the study population was 10% (interquartile range 0% to 23%; mean 14.9 +/- 16.1%). Using multiple linear regression analysis of 18 variables, left anterior descending infarct artery, baseline Thrombolysis In Myocardial Infarction grade 0/1 flow, male gender, and prolonged door-to-balloon time were powerful independent predictors of infarct size (all p <0.0001). Other independent correlates of infarct size were final Thrombolysis In Myocardial Infarction grade <3 flow (p = 0.0001), previous AMI (p = 0.005), symptom-onset-to-door time (p = 0.021), and rescue angioplasty (p = 0.026). In conclusion, anterior infarction, time to reperfusion, epicardial infarct artery patency before and after reperfusion, male gender, previous AMI, and failed thrombolytic therapy were important predictors of infarct size after angioplasty in patients with AMI assessed using technetium-99m sestamibi imaging and should be considered when planning future trials of investigational drugs or devices designed to enhance myocardial recovery.

The clinical impact of increasing levels of blood loss has been shown to increase morbidity and mortality after percutaneous coronary intervention (PCI). The impact of red blood cell (RBC) transfusion for severe bleeding is unknown. We systematically collected baseline and 8-h postprocedure hematocrit (HCT) values on patients undergoing PCI. The incidence of adverse events, including death and recurrent myocardial infarction, was correlated to increasing blood loss. A total of 6,799 patients undergoing PCI (January 2000 to April 2002) had serial HCT levels. Negligible, mild, moderate, and severe blood loss occurred in 43, 25, 25, and 8% of patients, respectively. In-hospital mortality was 0.3, 0.5, 1.4, and 5.7% (p < 0.0001) with increasing severity of blood loss. Blood transfusion was independently associated with mortality (relative risk [RR] 2.03, p = 0.028). A case-controlled analysis of 146 transfused patients versus 292 nontransfused patients with severe bleeding found an independent association between RBC transfusion and increased risk of 1-year mortality (RR 2.42, p = 0.0045). Patients receiving blood >35 days old had significantly worse 1-year survival rates compared with patients receiving blood <35 days old and patients not transfused (36 vs. 24 vs. 10%, p < 0.0001). In a general PCI population, increasing levels of blood loss are associated with an increased incidence of major adverse cardiac events and in-hospital mortality. RBC transfusion in the setting of severe bleeding is associated with an increased risk of 1-year mortality. Transfusion of aged RBCs may also be detrimental in this setting.

Objectives: This study sought to determine whether hyperoxemic reperfusion with aqueous oxygen (AO) improves recovery of ventricular function after percutaneous coronary intervention (PCI) for acute myocardial infarction (AMI)., Background: Hyperbaric oxygen reduces myocardial injury and improves ventricular function when administered during ischemia-reperfusion., Methods: In a prospective, multicenter study, 269 patients with acute anterior or large inferior AMI undergoing primary or rescue PCI (<24 h from symptom onset) were randomly assigned after successful PCI to receive hyperoxemic reperfusion (treatment group) or normoxemic blood autoreperfusion (control group). Hyperoxemic reperfusion was performed for 90 min using intracoronary AO. The primary end points were final infarct size at 14 days, ST-segment resolution, and delta regional wall motion score index of the infarct zone at 3 months., Results: At 30 days, the incidence of major adverse cardiac events was similar between the control and AO groups (5.2% vs. 6.7%, p = 0.62). There was no significant difference in the incidence of the primary end points between the study groups. In post-hoc analysis, anterior AMI patients reperfused <6 h who were treated with AO had a greater improvement in regional wall motion (delta wall motion score index = 0.54 in control group vs. 0.75 in AO group, p = 0.03), smaller infarct size (23% of left ventricle in control group vs. 9% of left ventricle in AO group, p = 0.04), and improved ST-segment resolution compared with normoxemic controls., Conclusions: Intracoronary hyperoxemic reperfusion was safe and well tolerated after PCI for AMI, but did not improve regional wall motion, ST-segment resolution, or final infarct size. A possible treatment effect was observed in anterior AMI patients reperfused <6 h of symptom onset.

Although there has been enthusiasm for using embolic protection devices in acute myocardial infarction, it is unclear how often these devices can be used in nonselected patients. The aim of this study was to evaluate potential eligibility for use of either proximal or distal embolic protection during primary or rescue percutaneous coronary intervention in a consecutive, nonselected population. We analyzed the angiograms of 259 consecutive patients with ST-segment elevation myocardial infarction to determine eligibility for use of either type of protection device. Overall, 202 (78%) patients had anatomy suitable for embolic protection, including 154 (59%) who were eligible for proximal protection, 128 (49%) who were eligible for distal protection, and 80 (31%) who were eligible for both devices. Patients eligible for proximal protection were more likely to have a right coronary culprit, whereas patients eligible for distal protection were more likely to have a lesion in the left anterior descending coronary artery.

We evaluated the prognostic effect of baseline left ventricular function and the determinants of its recovery after acute myocardial infarction (AMI) treated by primary angioplasty. Left ventriculography was performed during the index procedure in 1,620 of 2,082 patients (78%) who underwent primary angioplasty for AMI in the CADILLAC trial. One-year survival rate was significantly lower in patients whose baseline left ventricular ejection fraction (LVEF) was <40% than in those whose LVEF was > or =40% (89.0% vs 97.2%, respectively, p <0.0001). The effect of baseline left ventricular dysfunction on mortality was confined to the first 3 months after AMI; thereafter, survival was independent of baseline LVEF. By multivariate analysis, baseline LVEF (hazard ratio 0.93, 95% confidence interval 0.90 to 0.97, p <0.001) and infarct zone regional wall motion (hazard ratio 2.67, 95% confidence interval 1.08 to 6.63, p = 0.03) were independent predictors of 1-year mortality. Seven-month convalescent LVEF was also directly related to baseline LVEF and inversely correlated with previous AMI, multivessel coronary disease, preprocedural Thrombolysis In Myocardial Infarction grade 0 to 2 flow, larger infarct artery diameter, and infarct artery restenosis at follow-up. In conclusion, baseline left ventricular function measured during the index procedure is a strong independent predictor of early and late survival after primary angioplasty. Simple clinical and angiographic features readily available at the time of primary angioplasty also predict convalescent LVEF and are thus of prognostic utility.

We examined the incidence, presentation, and outcome of patients who developed gastrointestinal bleeding after percutaneous coronary intervention for acute myocardial infarction in the Primary Angioplasty in Myocardial Infarction trials. Of the 3,130 patients, 71 (2.3%) developed gastrointestinal bleeding, which was more likely to occur in elderly patients. Gastrointestinal bleeding was independently associated with a prolonged hospital stay and greater in-hospital and 6-month mortality.

We compared the procedural success, mechanism of failure, and safety of percutaneous coronary intervention in 235 procedures for de novo chronic total occlusions with 78 procedures for chronic occlusive in-stent restenosis. Despite similar rates of procedural success and safety profile, angiographic predictors of successful percutaneous coronary intervention for de novo chronic total occlusions played a limited role in patients who had chronic occlusive in-stent restenosis, and the mechanisms of failure were different.

We conducted an analysis of the frequency and variables associated with early (after 1 month) and late (after 6 months) return to work after percutaneous coronary intervention for acute myocardial infarction in patients who had been randomized in the Stent Primary Angioplasty in Myocardial Infarction trial. Of 450 patients who were employed before the acute myocardial infarction, 230 (51%) returned to work within 1 month with no increases in in-hospital and 1- or 6-month event rates compared with those who did not return to work. Multivariate analysis showed that predictors of early return to work were employment in the United States, no history of smoking, and single-vessel coronary disease. At 6 months, 353 of 435 patients (78%) had returned to work, and multivariate analysis showed that predictors of late return to work were employment in the United States and absence of angina.

Aims: To investigate whether the vasoconstrictor isoprostane F2alpha-III (iPF2alpha-III), released during myocardial reperfusion, contributes to the low/no reflow phenomenon observed following acute myocardial infarction (AMI)., Methods and Results: Thirteen patients undergoing primary percutaneous coronary intervention (PCI) for AMI had iPF2alpha-III measured by high-performance liquid and gas chromatography-mass spectrometry. Isoprostane F2alpha-III concentrations were significantly higher following PCI than in controls (1.5+/-1.3 vs.16+/-0.06 nM, p < 0.001). Mean iPF2alpha-III concentration correlated positively with ST-segment resolution at 90 min (R = 0.62, p < 0.05). In the isolated murine heart: (a) coronary vasoconstriction occurred at, or above, iPF2alpha-III concentrations of 1 microM. From 1 to 10 microM, iPF2alpha-III induced dose-dependent vasoconstriction (p = 0.005) with reduction in coronary flows (f) of 57+/-5% and 31+/-4% (percentage baseline), respectively; (b) SQ29548 1 microM completely reversed the vasoconstrictive effects of iPF2alpha-III 10 microM; (c) SQ29548 1 microM infused during reperfusion following 30 min ischaemia had no effect on CF or infarct volume., Conclusion: Concentrations of iPF2alpha-III released into the venous circulation during reperfusion following AMI in humans are significantly lower than those required to diminish coronary flow in the murine heart; increased levels indicate successful reperfusion. Inhibition of iPF2alpha-III has no effect on coronary flow or infarct size in the murine heart, suggesting that iPF2alpha-III alone does not account for the low/no reflow phenomenon observed following AMI.

We performed a pooled analysis of the Primary Angioplasty in Myocardial Infarction (PAMI) trials to examine predictors of death after primary percutaneous coronary intervention. Using these data, we developed a risk score with a range of 0 to 15 points. The PAMI risk score was found to be a strong predictor of late mortality.

We sought to characterize the outcome in patients who were on long-term dialysis and who underwent primary percutaneous transluminal coronary angioplasty (PTCA) for acute myocardial infarction. Of 2,831 consecutive patients who underwent primary PTCA for acute myocardial infarction from 1993 to 2001, 15 patients on long-term dialysis were identified. This small cohort had a 40% incidence of cardiogenic shock on admission. Despite the angiographic success rate for primary PTCA of 80%, in-hospital mortality was 53%.

Objectives: We examined the association between glycemic control determined by preprocedural hemoglobin A1c (A1c) and the incidence of target vessel revascularization (TVR) in diabetic patients undergoing elective percutaneous coronary intervention (PCI)., Background: Patients with diabetes mellitus (DM) have increased rates of restenosis and a worse clinical outcome after PCI than patients without DM., Methods: A total of 239 patients (60 without DM and 179 with DM) were enrolled in this study. Optimal glycemic control was defined as A1c < or =7%, and suboptimal control was defined as A1c >7%. Follow-up was performed at six and 12 months after the index intervention., Results: Diabetic patients with optimal glycemic control had a rate of 12-month TVR similar to that of nondiabetic patients (15% vs. 18%, p = NS). Diabetic patients with A1c >7% had a significantly higher rate of TVR than those with A1c <7% (34% vs. 15%, p = 0.02). In a multiple logistic regression analysis, A1c >7% was a significant independent predictor of TVR (odds ratio 2.87, 95% confidence interval 1.13 to 7.24; p = 0.03). Optimal glycemic control was associated with a lower rate of cardiac rehospitalization (15% vs. 31%, p = 0.03) and recurrent angina (13% vs. 37%, p = 0.002) at 12-month follow-up., Conclusions: In diabetic patients undergoing elective PCI, optimal glycemic control (A1c < or =7%) is associated with a lower rate of TVR, cardiac rehospitalization, and recurrent angina. These data suggest that aggressive treatment of DM to achieve A1c < or =7% is beneficial in improving the clinical outcome after PCI.

Background: The prognostic importance of renal insufficiency (RI) in patients undergoing primary percutaneous coronary intervention (PCI) for acute myocardial infarction (AMI) has not been well characterized., Methods and Results: PCI was performed in 2082 AMI patients without shock presenting within 12 hours of symptom onset in a prospective, multicenter randomized trial. RI was defined as a calculated (Cockroft-Gault) creatinine clearance (CrCl) < or =60 mL/min. RI at baseline was present in 18% of patients. Compared with patients without RI, patients with RI were older and were more likely to be female; to have hypertension, peripheral vascular disease, or cerebrovascular disease; and to present in heart failure. Mortality was markedly increased in patients with versus without baseline RI both at 30 days (7.5% versus 0.8%, P<0.0001) and at 1 year (12.7% versus 2.4%, P<0.0001). Mortality rates increased incrementally for every 10-mL/min decrease in baseline CrCl. By multivariate analysis, reduced baseline CrCl was a powerful independent predictor of 30-day mortality (hazard ratio, 5.77; P<0.0001) and remained associated with reduced survival at 1 year (hazard ratio, 1.98; P=0.08). Hemorrhagic complications and transfusion requirements were also increased more than 2-fold in patients with RI, as were severe restenosis (diameter stenosis > or =70%; 20.6% versus 11.8%, P=0.024) and infarct artery reocclusion (14.7% versus 7.3%, P=0.02)., Conclusions: Baseline RI in patients with AMI undergoing primary PCI is associated with a markedly increased risk of mortality, as well as bleeding and restenosis. Novel approaches are needed to improve the otherwise poor prognosis of patients with RI and AMI.

Abnormalities in plasma glucose below the "diabetic range" of glycemia are associated with increased cardiovascular morbidity and mortality in patients without diabetes mellitus. The purpose of this study was to investigate the relation between ambient glycemic levels as measured by hemoglobin A1c and outcome after elective percutaneous coronary intervention (PCI). Baseline laboratory studies, including hemoglobin A1c, were drawn in 500 consecutive patients before elective PCI. Nondiabetic patients were defined as those without a history of diet or pharmacologically controlled diabetes mellitus and a hemoglobin A1c level <7.0%. Of the 500 patients studied, 291 (59%) were nondiabetic patients. Abnormal hemoglobin A1c levels (6% to 7%) were found in 30% of nondiabetic patients. Nondiabetic patients with an abnormal hemoglobin A1c level had a significantly higher rate of major adverse cardiac events (33% vs 22%, p = 0.04), target vessel revascularization (31% vs 19%, p = 0.02), and cardiovascular mortality (4.6% vs 0.5%, p = 0.03) compared with nondiabetic patients with hemoglobin A1c levels <6%. Multivariate analysis disclosed that a hemoglobin A1c level of 6% to 7% was a significant independent predictor of major adverse cardiac events, target vessel revascularization, and cardiovascular mortality 12 months after PCI in nondiabetic patients. These data demonstrate that an abnormal hemoglobin A1c level may have prognostic significance in nondiabetic patients who undergo PCI.

Objectives: This study was designed to evaluate the safety profile of glycoprotein IIb/IIIa receptor inhibitors (GPI) in octogenarians undergoing percutaneous coronary intervention (PCI)., Background: Patients > or =80 years old constitute the fastest growing segment of the U.S. population and have a high prevalence of coronary artery disease. Few data exist regarding the use of GPI during PCI in octogenarians, as these patients have been excluded from randomized clinical trials of GPI., Methods: Consecutive patients > or =80 years old undergoing PCI between January 1998 and June 2001 were evaluated for clinical outcomes and bleeding complications., Results: One thousand three hundred and ninety two of 14,308 patients (9.7%) undergoing PCI were > or =80 years old. Of these, 459 of 1,392 (33%) of the patients were treated with GPI. Octogenarians treated with GPI were more likely to present with acute coronary syndrome or infarction, receive stents, require an intra-aortic balloon pump, or undergo multi-vessel PCI. Glycoprotein receptor inhibitor use was associated with a higher rate of bleeding, but the transfusion rate was similar to that in patients who did not receive GPI (9.8% vs. 8.6%, p = NS). No cases of intracranial hemorrhage were observed. By multivariate analysis, GPI treatment was associated with longer hospitalization but did not independently predict the need for transfusion or affect mortality., Conclusions: Octogenarians have a high incidence of bleeding and need for transfusion after PCI. Although the use of GPI was associated with more access and non-access site bleeding and longer hospital stay, GPI treatment does not significantly increase the risk of transfusion or intracranial hemorrhage in this non-randomized cohort.

Assessment of coronary lesion length using visual estimation or quantitative coronary angiography can be unreliable. We tested the accuracy of a new handheld caliper device to measure lesion length in a bench-top model and in eight patients undergoing percutaneous coronary intervention (PCI). Caliper-derived length measurements were compared to the known reference distance in the bench-top model and visual or intravascular ultrasound (IVUS)-derived measurements in vivo. In the coronary model, caliper-derived measurements were accurate and correlated well with known reference distances regardless of the angiographic projection. During PCI, there was a poor correlation between the best visual estimate of length and IVUS-derived measurements. In contrast, caliper-derived measurements correlated closely with IVUS-derived measurements. This handheld caliper provides a simple and accurate method of assessing intracoronary lesion length and may be particularly useful during coronary stenting and when adjunctive brachytherapy is performed., (Copyright 2003 Wiley-Liss, Inc.)

Objectives: The purpose of this study was to evaluate the safety and feasibility of endovascular cooling during primary percutaneous coronary intervention (PCI) for acute myocardial infarction (AMI)., Background: In experimental models of AMI, mild systemic hypothermia has been shown to reduce metabolic demand and limit infarct size., Methods: In a multi-center study, 42 patients with AMI (<6 h from symptom onset) were randomized to primary PCI with or without endovascular cooling (target core temperature 33 degrees C). Cooling was maintained for 3 h after reperfusion. Skin warming, oral buspirone, and intravenous meperidine were used to reduce the shivering threshold. The primary end point was major adverse cardiac events at 30 days. Infarct size at 30 days was measured using (99m)Tc-sestamibi SPECT imaging., Results: Endovascular cooling was performed successfully in 20 patients (95%). All achieved a core temperature below 34 degrees C (mean target temperature 33.2 +/- 0.9 degrees C). The mean temperature at reperfusion was 34.7 +/- 0.9 degrees C. Cooling was well tolerated, with no hemodynamic instability or increase in arrhythmia. Nine patients experienced mild episodic shivering. Major adverse cardiac events occurred in 0% vs. 10% (p = NS) of treated versus control patients. The median infarct size was non-significantly smaller in patients who received cooling compared with the control group (2% vs. 8% of the left ventricle, p = 0.80)., Conclusions: Endovascular cooling can be performed safely as an adjunct to primary PCI for AMI. Further clinical trials are required to determine whether induction of mild systemic hypothermia with endovascular cooling will limit infarct size in patients undergoing reperfusion therapy.

Cardiac tamponade is an uncommon but life-threatening complication of percutaneous coronary intervention (PCI). The purpose of the present study was to characterize the incidence, management, and clinical outcome associated with this complication. We analyzed a prospective database of 25,697 PCIs performed at William Beaumont Hospital (Royal Oak, Michigan) between October 1993 and December 2000. Cardiac tamponade was observed in 31 of 25,697 PCI procedures (0.12%). Cardiac tamponade was diagnosed in the catheterization laboratory in 17 of 31 patients (55%), and 14 patients (45%) had a delayed presentation (mean time from PCI 4.4 hours). Cardiac tamponade was twice as frequent after use of atheroablative devices compared with percutaneous transluminal coronary angioplasty and stenting (0.26% vs 0.11%, p <0.05). All patients with immediate cardiac tamponade had coronary artery perforation. In 11 of 14 patients with delayed tamponade (79%), no actual site of perforation could be identified. A moderate or large pericardial effusion was observed in 20 patients, and 9 had small effusions without typical echocardiographic features of tamponade. Pericardiocentesis was performed in 30 patients; 19 patients (61%) were treated successfully with aspiration alone, but 12 patients (39%) required further emergency surgical intervention. In-hospital complications included death (42%), emergency surgery (39%), myocardial infarction (29%), and transfusion (65%). Cardiac tamponade is an uncommon but important complication of PCI and is associated with high mortality and morbidity. Most cases are recognized in the catheterization laboratory, but delayed cardiac tamponade may occur and must be considered as a cause of late hypotension after PCI.

Objectives: The purpose of this study was to evaluate the feasibility and safety of intracoronary hyperoxemic reperfusion after primary angioplasty for acute myocardial infarction (MI)., Background: Hyperoxemic therapy with aqueous oxygen (AO) attenuates reperfusion injury and preserves left ventricular (LV) function in experimental models of MI., Methods: In a multi-center study of patients with acute MI undergoing primary angioplasty (PTCA), hyperoxemic blood (pO(2): 600 to 800 mm Hg) was infused into the infarct-related artery for 60 to 90 min after intervention. The primary end points were clinical, electrical and hemodynamic stability during hyperoxemic reperfusion and in-hospital major adverse cardiac events. Global and regional LV function was evaluated by serial echocardiography after PTCA, after AO infusion, at 24 h and at one and three months., Results: Twenty-nine patients were enrolled (mean age: 58.9+/-12.6 years). Hyperoxemic reperfusion was performed successfully in all cases (mean infusion time: 80.8+/-18.2 min; mean coronary perfusate pO(2): 631+/-235 mm Hg). There were no adverse events during hyperoxemic reperfusion or the in-hospital period. Compared with baseline, a significant improvement in global wall motion score index was observed at 24 h (1.68+/-0.24 vs. 1.48+/-0.24, p < 0.001) with a trend toward an increase in ejection fraction (48.6+/-7.3% vs. 51.8+/-6.8%, p = 0.08). Progressive improvement in LV function was observed at one and three months, primarily due to recovery of infarct zone function., Conclusions: Intracoronary hyperoxemic reperfusion is safe and well tolerated after primary PTCA. These preliminary data support the need for a randomized controlled trial to determine if hyperoxemic reperfusion enhances myocardial salvage or improves long-term outcome.