Unfractionated heparin versus bivalirudin in primary percutaneous coronary intervention (HEAT-PPCI): an open-label, single centre, randomised controlled trial.

BACKGROUND: Bivalirudin, with selective use of glycoprotein (GP) IIb/IIIa inhibitor agents, is an accepted standard of care in primary percutaneous coronary intervention (PPCI). We aimed to compare antithrombotic therapy with bivalirudin or unfractionated heparin during this procedure. METHODS: In our open-label, randomised controlled trial, we enrolled consecutive adults scheduled for angiography in the context of a PPCI presentation at Liverpool Heart and Chest Hospital (Liverpool, UK) with a strategy of delayed consent. Before angiography, we randomly allocated patients (1:1; stratified by age [<75 years vs ≥75 years] and presence of cardiogenic shock [yes vs no]) to heparin (70 U/kg) or bivalirudin (bolus 0·75 mg/kg; infusion 1·75 mg/kg per h). Patients were followed up for 28 days. The primary efficacy outcome was a composite of all-cause mortality, cerebrovascular accident, reinfarction, or unplanned target lesion revascularisation. The primary safety outcome was incidence of major bleeding (type 3-5 as per Bleeding Academic Research Consortium definitions). This study is registered with ClinicalTrials.gov, number NCT01519518. FINDINGS: Between Feb 7, 2012, and Nov 20, 2013, 1829 of 1917 patients undergoing emergency angiography at our centre (representing 97% of trial-naive presentations) were randomly allocated treatment, with 1812 included in the final analyses. 751 (83%) of 905 patients in the bivalirudin group and 740 (82%) of 907 patients in the heparin group had a percutaneous coronary intervention. The rate of GP IIb/IIIa inhibitor use was much the same between groups (122 patients [13%] in the bivalirudin group and 140 patients [15%] in the heparin group). The primary efficacy outcome occurred in 79 (8·7%) of 905 patients in the bivalirudin group and 52 (5·7%) of 907 patients in the heparin group (absolute risk difference 3·0%; relative risk [RR] 1·52, 95% CI 1·09-2·13, p=0·01). The primary safety outcome occurred in 32 (3·5%) of 905 patients in the bivalirudin group and 28 (3·1%) of 907 patients in the heparin group (0·4%; 1·15, 0·70-1·89, p=0·59). INTERPRETATION: Compared with bivalirudin, heparin reduces the incidence of major adverse ischaemic events in the setting of PPCI, with no increase in bleeding complications. Systematic use of heparin rather than bivalirudin would reduce drug costs substantially. FUNDING: Liverpool Heart and Chest Hospital, UK National Institute of Health Research, The Medicines Company, AstraZeneca, The Bentley Drivers Club (UK).

Funnel plots for comparing performance of PCI performing hospitals and cardiologists: demonstration of utility using the New York hospital mortality data.

BACKGROUND: The New York State Department of Health collects and reports outcome data on the hospitals and cardiologists who perform percutaneous coronary intervention (PCI) to allow them to examine their quality of care. Results are provided in tabular form. However funnel plots are the display method of choice for comparison of institutions and operators, using the principles of statistical process control (SPC). We aimed to demonstrate that funnel plots, which aid a meaningful interpretation of the results, can be derived from the New York PCI dataset. METHODS: The risk-adjusted mortality rates for 48 hospitals and cardiologists performing PCI were used for this analysis. Funnel plots (with control limits at 3 and 2 sigma) of all hospitals and operators performing PCI procedures were generated. Separate plots for emergency and nonemergency PCI procedures were derived. RESULTS: 149,888 patients underwent PCI procedures between January 1, 2002 and December 31, 2004. The 3-year risk-adjusted mortality rates for all PCI patients ranged from 0.00 to 1.37%. The funnel plots show risk-adjusted mortality rates against the denominator for that percentage (number of cases), displayed as a scatter plot and compared with the binomial funnel plot calculated around the mean for all cases reported. The risk-adjusted mortality rates of all hospitals were within 3 sigma (99.8%) upper control limits. The risk-adjusted mortality rates for three hospitals were above or on the upper warning limit (2 sigma control limit, equating to the 95% confidence interval) and three hospitals had risk-adjusted mortality rates below the 2 and 3 sigma control limits. CONCLUSION: The SPC funnel plot is an easy-to-interpret, risk-adjusted means of identifying units whose performance, in terms of mortality, diverges significantly from the population mean. Funnel plots may be applied to a complex dataset and allow a visual comparison of data derived from multiple healthcare units. Variation is readily identified permitting hospitals and cardiologists to appraise their practices so that effective quality improvement may take place.

A direct comparison of decision rules for early discharge of suspected acute coronary syndromes in the era of high sensitivity troponin.

BACKGROUND: We tested the hypothesis that a single high sensitivity troponin at limits of detection (LOD HSTnT) (<5 ng/l) combined with a presentation non-ischaemic electrocardiogram is superior to low-risk Global Registry of Acute Coronary Events (GRACE) (<75), Thrombolysis in Myocardial Infarction (TIMI) (≤1) and History, ECG, Age, Risk factors and Troponin (HEART) score (≤3) as an aid to early, safe discharge for suspected acute coronary syndrome. METHODS: In a prospective cohort study, risk scores were computed in consecutive patients with suspected acute coronary syndrome presenting to the Emergency Room of a large English hospital. Adjudication of myocardial infarction, as per third universal definition, involved a two-physician, blinded, independent review of all biomarker positive chest pain re-presentations to any national hospital. The primary and secondary outcome was a composite of type 1 myocardial infarction, unplanned coronary revascularisation and all cause death (MACE) at six weeks and one year. RESULTS: Of 3054 consecutive presentations with chest pain 1642 had suspected acute coronary syndrome (52% male, median age 59 years, 14% diabetic, 20% previous myocardial infarction). Median time from chest pain to presentation was 9.7 h. Re-presentations occurred in eight hospitals with 100% follow-up achieved. Two hundred and eleven (12.9%) and 279 (17%) were adjudicated to suffer MACE at six weeks and one year respectively. Only HEART ≤3 (negative predictive value MACE 99.4%, sensitivity 97.6%, %discharge 53.4) and LOD HSTnT strategy (negative predictive value MACE 99.8%, sensitivity 99.5%, %discharge 36.9) achieved pre-specified negative predictive value of >99% for MACE at six weeks. For type 1 myocardial infarction alone the negative predictive values at six weeks and one year were identical, for both HEART ≤3 and LOD HSTnT at 99.8% and 99.5% respectively. CONCLUSION: HEART ≤3 or LOD HSTnT strategy rules out short and medium term myocardial infarction with ≥99.5% certainty, and short-term MACE with >99% certainty, allowing for early discharge of 53.4% and 36.9% respectively of suspected acute coronary syndrome. Adoption of either strategy has the potential to greatly reduce Emergency Room pressures and minimise follow-up investigations. Very early presenters (<3 h), due to limited numbers, are excluded from these conclusions.

Rescue angioplasty after failed fibrinolysis for acute myocardial infarction: predictors of a failed procedure and 1-year mortality.

BACKGROUND: Rescue angioplasty (rPCI) for failed fibrinolysis is associated with a low mortality if successful, but a high mortality if it fails. The latter may reflect a high-risk group or harm in some patients. Predictors of success or failure of rPCI may aid selection of patients to be treated. METHODS: Unselected patients referred for rPCI from March 1994 to March 2005 were studied to determine the predictors of a failed procedure and 1-year mortality. RESULTS: Of 440 patients undergoing emergency coronary angiography for failed fibrinolysis (1-year mortality 18%), 101 had thrombolysis in myocardial infarction flow grade (TFG) 3 in the infarct-related vessel. rPCI was attempted in 318 of 339 patients with 75 years, shock, and final TFG < 3 were independent predictors of 1-year mortality. CONCLUSIONS: Cardiogenic shock is an independent predictor of a failed rPCI. Age group >75 years and shock were the only independent clinical predictors of 1-year mortality. These clinical variables may help in selecting patients for either a strategy of rescue angioplasty after failed fibrinolysis, or in selecting specific patients who might do better with a policy of primary angioplasty.

Early invasive versus conservative treatment in patients with failed fibrinolysis--no late survival benefit: the final analysis of the Middlesbrough Early Revascularisation to Limit Infarction (MERLIN) randomized trial.

BACKGROUND: Early (30 days) and midterm (6 months) clinical outcomes in trials comparing rescue angioplasty (rescue percutaneous coronary intervention [rPCI]) with conservative treatment of failed fibrinolysis complicating ST-segment elevation myocardial infarction have shown variable results. Whether early rPCI confers late (up to 3 years) clinical benefits is not known. METHODS: The MERLIN trial compared rPCI and a conservative strategy in patients with failed fibrinolysis complicating ST-segment elevation myocardial infarction. Three hundred seven patients with electrocardiographic evidence of failure to reperfuse at 60 minutes were included. Patients in cardiogenic shock were excluded. Thirty-day and 1-year results have been reported. Results of 3 years of follow-up are presented. RESULTS: Three-year mortality in the conservative arm and rPCI, respectively, was 16.9% versus 17.6% (P = .9, relative difference [RD] -0.8, 95% CI [-9.3 to 7.8]). Death rates were similar (3.9% vs 3.2%) between 1- and 3-year follow-up, respectively. The incidence of the composite secondary end point of death, reinfarction, stroke, unplanned revascularization, or heart failure was significantly higher in the conservative arm (64.3% vs 49%, P = .01, RD 15.3, 95% CI [4.2-26]). There was no significant difference in the rate of reinfarction (0.7% vs 0.7%) or heart failure (1.3% vs 2.7%) between 1 and 3 years between the conservative and rPCI arms, respectively. The incidence of subsequent unplanned revascularization at 3 years was significantly higher in the conservative arm (33.8% vs 14.4%, P < .01, RD 19.4, 95% CI [10-28.7]), most of which occurred within 1 year; the rates between 1 and 3 years were 3.9% in the conservative arm versus 2% in the rPCI arm. There was a trend toward fewer strokes in the conservative arm at 3 years (conservative arm 2.6% vs rPCI 6.5%, P = .1, RD -3.9%, 95% CI [-9.4 to 0.8]), with similar stroke rates (1.3% vs 1.3%) between 1- and 3-year follow-up. CONCLUSIONS: Rescue angioplasty did not confer a late survival advantage at 3 years. The composite end point occurred less often in the rPCI arm mainly because of fewer unplanned revascularization procedures in the early phase of follow-up. The highest risk of clinical events in patients with failed reperfusion is in the first year, beyond which the rate of clinical events is low.

A prospective randomised controlled trial to determine the early and late reactions after the use of iopamidol 340 (Niopam) and iomeprol 350 (Iomeron) in cardiac catheterisation.

UNLABELLED: A new generation of intravascular contrast agents, the non-ionic monomers have safety profiles that are superior to those of older ionic compounds. There are, however, significant differences between these agents. AIM: The aim of this study was to determine the incidence of early (<24h) and late (>24h to 7 days) reactions to two non-ionic contrast agents currently used during cardiac catheterisation: iopamidol 340 (Niopam Bracco UK Ltd.) and iomeprol 350 (Iomeron Bracco UK Ltd.). METHODS: This was a prospective, randomised, double blinded trial. One thousand nine hundred and eighty-five patients undergoing cardiac catheterisation received one of the following contrast agents on a weekly basis: iopamidol 340 (Niopam) and iomeprol 350 (Iomeron). Reactions that were possibly related to the contrast agents were recorded on predefined data collection forms during the first 24h of the procedure (early reaction) and after 24h to 7 days (late reaction) by means of a questionnaire. RESULTS: The baseline characteristics were matched in both the groups. There was no significant difference in the incidence of heat sensation experienced between the two groups (p=0.1). Early non-heat reactions occurred in 2.7% of patients receiving iopamidol 340 (Niopam) and 4% of those receiving iomeprol 350 (Iomeron) (p=0.1). Significant electrocardiographic changes were recorded in 1.7% of patients who received iopamidol 340 (Niopam), and 1% of those who received iomeprol 350 (Iomeron) (p=0.2). Bradycardia occurred more frequently in the iopamidol 350 group (0.8%) compared to the iomeprol 350 group (0.1%) p=0.02. Late reactions occurred in 16.2% of those receiving iopamidol 340 (Niopam) and 21.7% of those receiving iomeprol 350 (Iomeron) (p=0.02). A total of 23 (3.7%) patients in the iopamidol group and 39 (6.2%) patients in the iomeprol group reported nausea, p=0.01. CONCLUSIONS: The incidence of early adverse reactions was similar with the two non-ionic contrast agents. Although bradycardia was slightly more frequent using iopamidol 340, nausea was reported more commonly 24h after the procedure in patients receiving Iomeron 350 (Iomeron). We conclude that there were only minor clinical differences between these agents; both are safe and well tolerated.

Impact of implementation of evidence-based strategies to reduce door-to-balloon time in patients presenting with STEMI: continuous data analysis and feedback using a statistical process control plot.

BACKGROUND: Strategies to reduce DTB (door-to-balloon) time have been previously described. However, there is no well-established data-monitoring system that can be used for prompt feedback. The aims of this study were to use statistical process control (SPC) methodology to measure current processes, to provide real-time feedback on the impact of a change in service delivery and to identify individual outliers for specific investigation. METHODS: A prospective study was conducted in a tertiary centre in North England. Data were collected for 841 consecutive STEMI patients from the local district undergoing PPCI. The impact on median DTB time after changes in protocols were prospectively determined. RESULTS: Median DTB times fell significantly as a result of changes in protocol. The upper control limit (UCL) decreased from 209 to 86 min and narrower control limits indicated improved performance. The main outliers included patients presenting to the Accident and Emergency department and patients who developed STEMI while being treated in non-cardiology wards for other reasons (18.3% of the study population). CONCLUSIONS: SPC provides a statistically robust mechanism for assessing the effect of process redesign interventions, and in this context provides a clear visual representation of DTB times for individual patients. Identification of significant outliers allows investigation of any variation with a special cause. It allows a unit to identify when a system of service delivery, albeit stable, is inadequate and needs redesign and can monitor the impact of changes in protocol.

Is it ever worth contemplating an aortic valve replacement on patients with low gradient severe aortic stenosis but poor left ventricular function with no contractile reserve?

A best evidence topic in cardiac surgery was written according to a structured protocol. The question addressed was whether it is worth performing aortic valve replacement in patients with severe aortic stenosis and poor left ventricular function but no contractile reserve on dobutamine stress testing. Altogether 251 papers were identified using the below mentioned search and all major international guidelines were included. Fourteen presented the best evidence to answer the clinical question. The author, journal, date and country of publication, patient group, relevant outcomes and weaknesses were tabulated. We conclude that patients with severe aortic stenosis and a contractile reserve of <20% improvement in stroke volume on dobutamine stress testing have a very poor prognosis of only 10-20% at two years. Heart transplant would offer the best chance of survival to those eligible but for those not eligible, a surgical option should not be discounted for selected patients. The American Heart Association guidelines state that prognosis is very poor for either medical or surgical treatment, but the European Society of Cardiology guidelines state that surgery can be performed in these patients but should take into account the clinical condition of the patient. The operative mortality is around 30% and the French Multicentre study on low gradient aortic stenosis has shown that if the patient survives there is likely to be an improvement in symptoms and ejection fraction. Thus, absence of contractile reserve on stress testing does not exclude myocardial recovery after surgery, although it is a strong predictor for operative mortality. It should be noted that surgery has only been reported in very few of these patients to date. B-natriuretic peptide has also been suggested as a further marker of better prognosis in these high-risk patients in one small study.

Is it worth performing surgical ventricular restoration in patients with ischemic cardiomyopathy and akinetic but non-aneurysmal segments in the left ventricle?

A best evidence topic in cardiac surgery was written according to a structured protocol. The question addressed was whether it is worth performing surgical ventricular restoration (SVR) in patients with ischemic cardiomyopathy and akinetic but non-aneurysmal segments in the left ventricle. Altogether 237 papers were identified using the below mentioned search. Fifteen presented the best evidence to answer the clinical question. The author, journal, date and country of publication, patient group, relevant outcomes and weaknesses were tabulated. The RESTORE group and others have demonstrated that in patients with ischaemic cardiomyopathy and an akinetic anterior ventricular wall, significant improvements in survival and symptoms can be obtained with an acceptable operative risk. Improvements in EF of 10-15% have been consistently demonstrated with significant improvements in symptoms also. The RESTORE group peri-operative mortality was 5.3%. Currently, 25% of US centres participating in the National Cardiac Database have performed at least one SVR procedure, although most only perform low numbers. In this database over 2 years from 2002, there were 731 procedures. The mortality was 9.4% and 33% of patients suffered a major complication or death, cautioning that in the 'real-world' results may not be as good as those from high volume tertiary referral centres. Patient selection may be a reason for these differences. The STICH trial has now completed the recruitment of 2136 patients into a randomised trial of medical therapy vs. coronary artery bypass grafting (CABG) vs. CABG and SVR surgery. With first results expected in 2009, this study will be a landmark in providing the evidence base for the selection of patients for surgical ventricular restoration surgery.

Cumulative funnel plots for the early detection of interoperator variation: retrospective database analysis of observed versus predicted results of percutaneous coronary intervention.

OBJECTIVE: To use funnel plots and cumulative funnel plots to compare in-hospital outcome data for operators undertaking percutaneous coronary interventions with predicted results derived from a validated risk score to allow for early detection of variation in performance. DESIGN: Analysis of prospectively collected data. SETTING: Tertiary centre NHS hospital in the north east of England. PARTICIPANTS: Five cardiologists carrying out percutaneous coronary interventions between January 2003 and December 2006. MAIN OUTCOME MEASURES: In-hospital major adverse cardiovascular and cerebrovascular events (in-hospital death, Q wave myocardial infarction, emergency coronary artery bypass graft surgery, and cerebrovascular accident) analysed against the logistic north west quality improvement programme predicted risk, for each operator. Results are displayed as funnel plots summarising overall performance for each operator and cumulative funnel plots for an individual operator's performance on a case series basis. RESULTS: The funnel plots for 5198 patients undergoing percutaneous coronary interventions showed an average observed rate for major adverse cardiovascular and cerebrovascular events of 1.96% overall. This was below the predicted risk of 2.06% by the logistic north west quality improvement programme risk score. Rates of in-hospital major adverse cardiovascular and cerebrovascular events for all operators were within the 3sigma upper control limit of 2.75% and 2sigma upper warning limit of 2.49%. CONCLUSION: The overall in-hospital major adverse cardiovascular and cerebrovascular events rates were under the predicted event rate. In-hospital rates after percutaneous coronary intervention procedure can be monitored successfully using funnel and cumulative funnel plots with 3sigma control limits to display and publish each operator's outcomes. The upper warning limit (2sigma control limit) could be used for internal monitoring. The main advantage of these charts is their transparency, as they show observed and predicted events separately. By this approach individual operators can monitor their own performance, using the predicted risk for their patients but in a way that is compatible with benchmarking to colleagues, encapsulated by the funnel plot. This methodology is applicable regardless of variations in individual operator case volume and case mix.

Modifiable risk factors remain significant causes of medium term mortality after first time Coronary artery bypass grafting.

BACKGROUND: Whilst there is much current data on early outcomes after Coronary artery bypass grafting(CABG), there is relatively little data on medium term outcomes in the current era. The purpose of this study is to present a single surgeon series comprising of all first time CABG patients operated on with the technique of cross clamp fibrillation from Feb-1996 to through to Jan-2003, and to seek risk factors for medium term mortality in these patients. METHODS: Data was collected from Hospital Episode Statistics and departmental patient administration and tracking systems and cross checked using database techniques. Patient outcomes were searched using the National Health Service strategic tracing service. RESULTS: Mean follow up was 5.3 years(0-9.4 years) and was complete for all patients. 30-day survival was 98.4%, 1-year survival 95% and 8-year survival 79%. Cox-regression analysis revealed that several modifiable pre-operative risk factors remain significant predictors of medium term mortality, including Diabetes(Hazard Ratio(HR) 1.73, 95%CI 1.21-2.45), Chromic obstructive pulmonary disease(HR 2.02, 95%CI 1.09-3.72), Peripheral vascular disease(HR 1.68, 95%CI 1.13-2.5), Body mass index>30(HR 1.54, 95%CI 1.08-2.20) and current smoker at operation(HR 1.67, 95%CI 1.03-2.72). However hypertension(HR 1.31, 95%CI 0.95-1.82) and Hypercholestrolaemia(HR 0.81, 95%CI 0.58-1.13) were not predictive which may reflect adequate post-operative control. CONCLUSION: Coronary artery bypass surgery using cross clamp fibrillation is associated with a very low operative mortality. Medium term survival is also good but risk factors such as smoking at operation, Chronic obstructive pulmonary disease, obesity and diabetes negatively impact this survival and should be aggressively treated in the years post-surgery.

Treatment of restenosis after bare-metal and drug-eluting stenting of an aorto-ostial lesion: challenges associated with excessive stent overhang.

Percutaneous coronary interventions of ostial right coronary artery stenoses are associated with increased procedural complications as well as with higher rates of angiographic and clinical restenosis. Ideally, the ostium is treated by positioning the stent with a slight degree of overhang in the aorta to ensure coverage of the aorto-ostial junction. This can potentially complicate further intervention should restenosis occur. We report a case in which in-stent restenosis of an overhanging stent had been treated with an also overhanging sirolimus-coated Cypher stent (Cordis Corporation, Roden, The Netherlands). Late repeat restenosis was treated with a third (Taxus, Boston Scientific, Maple Grove, Minnesota, USA) stent that was deployed through the previously implanted stent struts.

Should the tricuspid valve be replaced with a mechanical or biological valve?

A best evidence topic in cardiac surgery was written according to a structured protocol. The question addressed was whether patients requiring tricuspid replacement should have a mechanical or a biological valve. Using the reported search, 561 papers were identified. Thirteen papers represented the best evidence on the subject. The author, journal, date and country of publication, patient group studied, study type, relevant outcomes, weaknesses, results and study comments were tabulated. We conclude that there are no major differences between the insertion of a mechanical or biological tricuspid valve. Aggregating the available data it is found that the reoperation rate is similar with bioprosthetic degeneration rate being equivalent to the mechanical thrombosis rate. Conversely up to 95% of patients with a bioprosthesis still receive anticoagulation. Survival in over 1000 prostheses pooled by meta-analysis was equivalent between biological and mechanical valves.

Towards an understanding of the role of rescue angioplasty for failed fibrinolysis: comparison of the MERLIN, RESCUE and REACT trials.

UNLABELLED: The large randomized trials on rescue angioplasty (rPCI) have been interpreted by some as showing differing results. We compared the protocols, demographics and 6-month clinical outcomes of the MERLIN trial with the RESCUE I and REACT trials to assess their differences. RESULTS: The RESCUE I trial did not involve the use of stenting or glycoprotein IIb/IIIa inhibitors, and patients with previous MI were excluded. The recruitment rate in MERLIN was 30.7 patients per center per year vs. 3.3 in REACT and 2.4 in the RESCUE I trial. The patients in the MERLIN trial were older. Streptokinase was used more commonly in the MERLIN trial: 96% vs. 60% in REACT. In the rPCI arm, pain onset to lysis time was longer, 180 vs. 140 minutes in MERLIN, but lysis to angiography (146 vs. 274 minutes) and pain onset to angiography (327 vs. 414 minute) times were shorter compared with the REACT trial. In the rPCI arms, mortality at 6 months was lower in the REACT trial than in the MERLIN trial although the difference was not statistically significant. This numeric difference in mortality is unlikely to be explained by the differences in the use of glycoprotein IIb/IIIa inhibitors or stenting. In the rPCI arms, reinfarction rates were higher in the MERLIN trial (7.8% vs. 2.1%), possibly due to lower rates of stenting (50.3% vs. 68.5%) and less use of glycoprotein IIb/IIIa inhibitors (3.3% vs. 43.4%). The three trials used different definitions of heart failure, with a trend towards a reduction in heart failure in all three studies. CONCLUSION: These trials differ in various aspects. The RESCUE I trial enrolled lower-risk patients than the MERLIN trial and was done without the use of stents and glycoprotein IIb/IIIa inhibitors. The MERLIN trial is widely applicable to patients receiving streptokinase and had no age limit. REACT patients were younger and were enrolled more selectively. Although some outcomes were similar, differences in patient recruitment and protocols may have accounted for the numerical difference in mortality rates at 6 months in the MERLIN and REACT trials. Meta-analysis suggests an overall clinical benefit from rescue PCI (lower mortality, less reinfarction and less heart failure) at the expense of an increased risk of stroke and bleeding.

Meta-analysis of randomized trials comparing anti-embolic devices with standard PCI for improving myocardial reperfusion in patients with acute myocardial infarction.

BACKGROUND: Failure to achieve adequate myocardial reperfusion often occurs during PCI in patients with STEMI. This is in part due to atheromatous and thrombotic distal embolization. Several anti-embolic devices have been developed to protect against distal embolization during percutaneous coronary interventions (PCI) to improve myocardial reperfusion and enhance event free survival. Evidence from current studies has not shown a consistent benefit, but anti-embolic devices continue to be used. METHODS: We conducted a systemic overview (meta-analysis) of randomized trials of thrombectomy or distal protection devices versus standard PCI to evaluate the effects of reducing distal embolization during PCI for native vessel acute myocardial infarction (AMI). We identified randomized trials by searching PubMed, OVID, the Cochrane databases, references of articles, and abstracts of conference proceedings (all from September 2000 to October 2005). Each trial tested the hypothesis that anti-embolic therapy would result in better clinical or angiographic results than standard PCI alone. RESULTS: Fourteen trials (n = 2630) were identified comparing a distal protection device or a thrombectomy device (n = 1320) versus standard PCI (n = 1310). When the studies were combined, primary endpoints of death or reinfarction were not improved by the use of anti-embolic devices (4% [52/1309] vs. 4.5% [59/1303], odds ratio [OR] 0.82 [95% CI 0.55 to 1.24, P= 0.35]). In subgroup analysis, analyzing the class of device separately, use of thrombectomy devices (4.4% [33/758 vs. 4.2% [32/763], OR 0.98 CI 0.53 to 1.83, P = 0.95]), and the use of distal protection device 3.5% [19/551] vs. 5% [27/540], OR 0.68 CI 0.37 to 1.23, P = 0.20]) during PCI for native vessel AMI did not improve the clinical outcome of death or reinfarction. The secondary endpoints of death, reinfarction, and major adverse cardiac events did not improve with the use of anti-embolic devices. CONCLUSION: The combined experience from randomized trials suggests that the use of anti-embolic devices does not decrease early mortality or reinfarction during PCI for native vessel AMI. Whether their use improves longer term outcomes is unknown. Further research is needed to clarify the indication and optimal devices for anti-embolic protection.

Intra-aortic counterpulsation does not improve coronary flow early after PCI in a high-risk group of patients: observations from a randomized trial to explore its mode of action.

UNLABELLED: The intra-aortic balloon pump (IABP) is the most commonly used temporary cardiac assist device. The precise role and the mechanism of any benefit in high-risk patients undergoing percutaneous coronary intervention (PCI) have not been fully determined. We hypothesized that the use of an IABP following PCI in high-risk non-shocked patients would immediately increase coronary blood flow, tissue perfusion and hence preserve left ventricular function. METHODS: Predefined high-risk, but non-shocked, patients were randomized to either an IABP or no IABP following PCI. Angiography was performed pre-PCI, immediately post-PCI and 10 minutes after the completion of the procedure. TIMI flow grade (TFG), TIMI frame count (TFC) and myocardial blush grade (MBG) were measured. Echocardiographic wall motion index (WMI) was measured on days 1 and 30 following PCI. RESULTS: Of 33 patients, 17 received IABP and 16 did not. At final angiography, the TFG was 2.8 +/- 0.7 and 2.9 +/- 0.3 (p = 0.6), the TFC was 19.9 +/- 23 and 16.9 +/- 16.9 (p = 0.7), and the MBG was 2.5 +/- 0.9 and 2.5 +/- 0.7 (p = 0.9) in the IABP and the no-IABP arms. The WMI on day 1 was 1.7 +/- 0.4 and 1.7 +/- 0.4 (p = 0.7), and on day 30, it was 1.5 +/- 0.4 and 1.5 +/- 0.4 (p = 0.9). There was no difference in the total sum of ST-segment elevation prior to PCI (12.6 +/- 7.7 vs. 13.5 +/- 7.9; p = 0.8), nor in the summed ST change in subsequent electrocardiograms (ECGs) to 48 hours in both of the groups. CONCLUSION: Whether an IABP is of any benefit in non-shocked, but high-risk, patients undergoing PCI remains to be established, but any potential benefit does not appear to be associated with early improvement in coronary flow. Whether the insertion of an IABP improves coronary flow beyond 10 minutes is not known. However, the IABP did not significantly affect subsequent left ventricular wall motion index or ECG ST-segment resolution in this study.

Impact of catheter sizes and intracoronary glyceryl trinitrate on the TIMI frame count when digital angiograms are acquired at lower frame rates during elective angiography and PCI.

UNLABELLED: The TIMI frame count (TFC) is a useful measure of coronary flow. To be widely applicable, the effect of different catheter sizes and the use of intracoronary glyceryl trinitrate (ICGTN) must be determined when films are acquired at lower acquisition rates (12.5 frames/s, f/s). METHODS: We compared 6F versus 5F diagnostic catheters (n = 44), 6F versus 7F diagnostic catheters (n = 45) and 6F diagnostic versus 7F guide catheters (n = 44). In the nitrate angiography group (n = 141), coronary angiography was performed before and after 200 micrograms of ICGTN. In the nitrate percutaneous coronary intervention (PCI) group (n = 48), coronary angiography was performed before and after 200 micrograms of ICGTN after the completion of the elective PCI procedure. RESULTS: The mean difference in the uncorrected TFC using 6F and 5F was 0.02 (95 % CI -0.5, 0.6; P = 0.9); using 6F and 7F diagnostic catheters it was 0.3 (95% CI -0.49, 1.1; p = 0.4); and using 6F diagnostic and 7F guide catheters it was 0.4 (95% CI -2.6, 3.4; P = 0.7) respectively. In the nitrate angiography group, the uncorrected TFC before and after ICGTN was 13.1+/-6.2 and 15+/-7.5 (equivalent to 31.4+/-14.9 and 36+/-2 at 30 f/s), with a mean difference of 1.9 (95% CI 1.3, 2.5; P = or <0.0001). In the nitrate PCI group, the uncorrected TFC before and after ICGTN administration was 9.2+/-3.7 and 10.3+/-4.2 (equivalent to 22.6+/-9.6 and 25.2+/-11 at 30 f/s) respectively with a mean difference between the two injections of 1.2 (95% CI -0.4, 1.9; P = 0.003). CONCLUSION: We have demonstrated that the catheter sizes did not significantly affect the TFC when angiography was performed at 12.5f/s. The use of ICGTN significantly increased the TFC in both normal and diseased coronary arteries. This effect was also observed when ICGTN was administered into the culprit vessels after the completion of the elective PCI procedure. This effect must be considered when investigating the impact of specific treatments or drugs on coronary flow.

Meta-analysis of valve hemodynamics and left ventricular mass regression for stentless versus stented aortic valves.

BACKGROUND: Stentless aortic bioprostheses have been advocated as being superior to conventional bioprosthetic valves, with benefits including superior left ventricular mass regression and larger effective orifice area. Several high-quality randomized studies now exist on this topic, and we sought to summarize them by meta-analysis. METHODS: The literature was searched from 1995 to 2006, in MEDLINE, EMBASE, CRISP, metaRegister of Controlled Trials, and the Cochrane database. Experts were also contacted and reference lists searched. Studies were combined using the inverse variance fixed-effects model. Heterogeneity was assessed and a sensitivity analysis performed. Publication bias was also investigated. RESULTS: Ten studies were identified that included 919 patients in which the Freedom (Sorin Biomedica Cardio, Via Crescentino, Italy), Freestyle (Medtronic, Minneapolis, MN), Prima Plus (Edwards Life Sciences, Irvine, CA) and the Toronto and Biocor (St Jude Medical, St. Paul, MN) valves were used. The mean aortic valve gradient was lower in the stentless groups, with a weighted mean difference (WMD) of -3.57 mm Hg (95% confidence interval [CI], -4.36 to -2.78; p < 0.01). The left ventricular mass index was significantly lower in the stentless groups at 6 months (WMD, -6.42; 95% CI, -11.63 to -1.21; p = 0.02), but this improvement disappeared after 12 months (WMD, 1.19; 95% CI, -4.15 to 6.53; p = 0.66). The weighted mean increase in cross-clamp time was 23 minutes, and the increase in bypass time was 29 minutes with a stentless valve. CONCLUSIONS: This meta-analysis showed that stentless aortic valves provide an improved level of left ventricular mass regression at 6 months, reduced aortic gradients, and an improved effective orifice area index, at the expense of a 23-minute longer cross-clamp time and a 29-minute longer bypass time.

Should patients in cardiogenic shock undergo rescue angioplasty after failed fibrinolysis: comparison of primary versus rescue angioplasty in cardiogenic shock patients.

BACKGROUND: Trials of rescue angioplasty (rPCI) following failed fibrinolysis have excluded patients with cardiogenic shock and the benefit of rPCI in this setting is unknown. We compared the clinical, angiographic characteristics, 30-day and 1-year outcomes of cardiogenic shock patients undergoing rPCI with those undergoing primary percutaneous coronary intervention (PPCI). METHODS: Of the 171 patients undergoing PCI for cardiogenic shock between 1994 and 2005 at our institution, the indication was for PPCI in 65 and rPCI in 59 patients. Clinical, procedural, 30- day and 1-year mortality data were compared. RESULTS: There were no differences between the cohorts with regard to clinical and pre-PCI angiographic variables, except that patients who underwent rPCI were more likely to be interhospital transfers (64% vs. 43%; p = 0.02) and had a longer door-to-balloon time (median 298 [IQR 395 to 180] minutes in the rPCI group vs. 131 [IQR 215 to 90] minutes in the PPCI group; p <0.01). Glycoprotein IIb/IIIa inhibitors were used less often (20% vs. 42%; p = 0.01), but use of stents was similar in both groups. Patients undergoing rPCI had a lower rate of final TIMI 3 flow grade (56% vs. 74%; p = 0.04) and a higher 1-year mortality (71% vs. 49%; p = 0.01). In the patients with final TIMI flow 3, 1-year mortality was higher in the rPCI group (61% vs. 37%; p = 0.04). In patients with successful procedures (survived procedure, no emergency CABG, TIMI 3 flow), 1-year mortality was higher in the rPCI group (59% vs. 33%; p = 0.02). One-year mortality was 85% in both groups if the procedure was unsuccessful. One-year mortality in patients >70 years old with cardiogenic shock undergoing rPCI was 100% (n = 15) and 70% (n = 14) with PPCI. Rescue angioplasty, anterior myocardial infarction, multivessel disease and postprocedure TIMI flow grade <3 were found to be independent predictors of mortality at 30 days. CONCLUSIONS: In the setting of cardiogenic shock, rPCI patients were treated later than those undergoing PPCI. They had a lower final TIMI 3 flow and higher 1-year mortality. Even patients with a successful rPCI procedure had a higher 1-year mortality than those with a successful PPCI. Rescue angioplasty in the setting of cardiogenic shock was found be an independent predictor of mortality. Rescue angioplasty in elderly patients in cardiogenic shock (>75 years) may be a futile treatment. Efforts should be made to improve reperfusion and survival in these patients, possibly by either adopting PPCI for all patients presenting with ST-elevation acute myocardial infarction or, if this is not logistically possible, adopting PPCI for selected high-risk patients or early referral for rPCI in high-risk groups receiving fibrinolysis.

The impact of chronically diseased coronary arteries and stenting on the corrected TIMI frame count in elective coronary angiography and percutaneous coronary intervention procedures.

UNLABELLED: The impact of chronic coronary obstructions on resting blood flow in stable cardiac patients and the response to percutaneous coronary intervention (PCI) using the TIMI frame count method has not been well documented. We studied the impact of coronary artery stenosis severity on the corrected TIMI frame count (cTFC) in chronically stenosed coronary arteries. We prospectively and quantitatively determined the impact of stenting on the cTFC during elective PCI. METHODS: In substudy 1, analysis was performed to obtain the mean cTFC for arteries with <50% stenosis (Group A), 51-75% stenosis (Group B), 76-85% stenosis (Group C1), 86-95% stenosis (Group C2) and 96-99% stenosis (Group C3). In substudy 2, the cTFC and quantitative coronary angiography were performed pre- and post-PCI. RESULTS: In substudy 1, the cTFC increased exponentially beyond a diameter stenosis of 75% (P < 0.01). However there was no significant difference in the cTFC for coronary arteries with <75% stenosis. In substudy 2, the overall pre- and poststenting cTFC was 17.1 +/- 11.7 and 7.8 +/- 2.7 (P < 0.01) and the TFC index [calculated by dividing the mean cTFC for the relevant artery by the mean cTFC for the corresponding coronary artery in a previously derived control group in our laboratory] was 1.6 +/- 1 and 0.7 +/- 0.2 (P = < 0.01), respectively. CONCLUSION: We have demonstrated that there was a significant increase in the cTFC when the coronary artery stenosis was more than 75% reflecting significant flow abnormalities at this degree of stenosis in chronically diseased coronary arteries. Following stenting there is a significant improvement in the cTFC, which is better than the cTFC for arteries with normal flow, suggesting early hyperaemia.