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OBJECTIVE: To investigate the use of prasugrel after percutaneous coronary intervention (PCI) in African American (AA) patients presenting with acute coronary syndrome (ACS). BACKGROUND: AA patients are at higher risk for adverse cardiovascular outcomes after PCI and may derive greater benefit from the use of potent antiplatelet therapy. METHODS: Using the multicenter PROMETHEUS observational registry of ACS patients treated with PCI, we grouped patients by self-reported AA or other races. Clinical outcomes at 90-day and 1-year included non-fatal myocardial infarction (MI), major adverse cardiac events (composite of death, MI, stroke, or unplanned revascularization) and major bleeding. RESULTS: The study population included 2,125 (11%) AA and 17,707 (89%) non-AA patients. AA patients were younger, more often female (46% vs. 30%) with a higher prevalence of diabetes mellitus, chronic kidney disease, and prior coronary intervention than non-AA patients. Although AA patients more often presented with troponin (+) ACS, prasugrel use was much less common in AA vs. non-AA (11.9% vs. 21.4%, respectively, P = 0.001). In addition, the use of prasugrel increased with the severity of presentation in non-AA but not in AA patients. Multivariable logistic regression showed AA race was an independent predictor of reduced use of prasugrel (0.42 [0.37-0.49], P

BACKGROUND: Clinical trial data studies suggest superiority of prasugrel over clopidogrel in patients with diabetes. However, the use, safety and efficacy profile of prasugrel in unselected diabetic patients presenting with acute coronary syndromes (ACS) remain unclear. METHODS: PROMETHEUS was a prospective multicenter observational study of 19,919 ACS PCI patients enrolled between 2010 and 2013. The primary endpoint was 90-day major adverse cardiovascular events (MACE), comprising all-cause death, myocardial infarction, stroke or unplanned revascularization. The safety endpoint was bleeding requiring hospitalization. RESULTS: We identified 7580 (38%) subjects with and 12,329 (62%) without diabetes. Diabetic patients were older and had significantly higher rates of cardiovascular risk factors. However, they were less likely to receive prasugrel (18.2% vs. 21.7%). Use of prasugrel did not increase with the severity of clinical presentation in diabetics, whereas, among non-diabetics, prescription of prasugrel was higher in NSTEMI and STEMI compared to unstable angina. The 90-day and 1-year adjusted risk of MACE was greater in diabetics (at 1 year: 22.7% vs. 16.5%; HR 1.22 [1.14-1.33], p

We sought to investigate the utilization of prasugrel and its association with outcomes relative to clopidogrel in three typical subgroups of ACS in a real-world setting. Prasugrel is superior to clopidogrel for reducing risk of ischemic events in acute coronary syndrome (ACS) patients undergoing percutaneous coronary intervention (PCI), but is associated with an increased risk of bleeding complications. PROMETHEUS was a retrospective multicenter observational study of 19,913 ACS patients undergoing PCI from 8 centers in the United States between 2010 and 2013. Major adverse cardiovascular events (MACE) were defined as a composite of all-cause mortality, myocardial infarction, stroke or unplanned revascularization. The study cohort included 3285 (16.5%) patients with ST-segment elevation myocardial infarction (STEMI), 5412 (27.2%) patients with NSTEMI and 11,216 (56.3%) patients with unstable angina (UA). The frequency of prasugrel use at discharge was highest in STEMI and lowest in UA patients, 27.3% versus 22.2% versus 18.9% (p < 0.001). Use of prasugrel vs clopidogrel was associated with a lower rate of MACE in STEMI, NSTEMI, or UA at 1 year, but the differences were attenuated for all groups except for patients with UA (adjusted HR 0.81, 95% CI 0.69–0.94, p = 0.006) after propensity adjusted analysis. After adjustment, there was no difference in bleeding risk between prasugrel and clopidogrel for all groups at 1 year. STEMI patients were more likely to receive prasugrel compared to NSTEMI and UA patients. Prasugrel was associated with reduced adverse outcomes compared with clopidogrel in unadjusted analyses, findings that were largely attenuated upon adjustment and suggest preferential use of prasugrel in low vs high risk patients.

Cardiovascular disease has been the leading cause of death in industrialized nations since the early 1900s. According to the American Heart Association, there are more than 1 million new and recurrent cardiac events occurring each year. Those with a history of cardiac ischaemic events have a high risk of recurrent events; however, the death rate from coronary artery disease declined from 1995 to 2005 by 26%. Thus, the burden of chronic non-fatal coronary artery disease remains high and therefore underscores the importance of secondary prevention measures. This chapter focuses on lifestyle modification, which is considered a major component of secondary prevention.

BACKGROUND: Potent P2Y12 inhibitors might offer enhanced benefit against thrombotic events in complex percutaneous coronary intervention (PCI). We examined prasugrel use and outcomes according to PCI complexity, as well as analyzing treatment effects according to thienopyridine type. METHODS: PROMETHEUS was a multicentre observational study that compared clopidogrel vs prasugrel in acute coronary syndrome patients who underwent PCI (n = 19,914). Complex PCI was defined as PCI of the left main, bifurcation lesion, moderate-severely calcified lesion, or total stent length ≥ 30 mm. Major adverse cardiac events (MACE) were a composite of death, myocardial infarction, stroke, or unplanned revascularization. Outcomes were adjusted using multivariable Cox regression for effect of PCI complexity and propensity-stratified analysis for effect of thienopyridine type. RESULTS: The study cohort included 48.9% (n = 9735) complex and 51.1% (n = 10,179) noncomplex patients. Second generation drug-eluting stents were used in 70.1% complex and 66.2% noncomplex PCI patients (P < 0.0001). Complex PCI was associated with greater adjusted risk of 1-year MACE (hazard ratio [HR], 1.29; 95% confidence interval [CI], 1.20-1.39; P < 0.001). Prasugrel was prescribed in 20.7% of complex and 20.1% of noncomplex PCI patients (P = 0.30). Compared with clopidogrel, prasugrel significantly decreased adjusted risk for 1-year MACE in complex PCI (HR, 0.79; 95% CI, 0.68-0.92) but not noncomplex PCI (HR, 0.91; 95% CI, 0.77-1.08), albeit there was no evidence of interaction (P interaction = 0.281). CONCLUSIONS: Despite the use of contemporary techniques, acute coronary syndrome patients who undergo complex PCI had significantly higher rates of 1-year MACE. Adjusted magnitude of treatment effects with prasugrel vs clopidogrel were consistent in complex and noncomplex PCI without evidence of interaction.

Objectives This study sought to compare clinical outcomes in a contemporary acute coronary syndrome (ACS) percutaneous coronary intervention (PCI) cohort stratified by chronic kidney disease (CKD) status. Background Patients with CKD exhibit high risks for both thrombotic and bleeding events, thus complicating decision making regarding antiplatelet therapy in the setting of ACS. Methods The PROMETHEUS study was a multicenter observational study comparing outcomes with prasugrel versus clopidogrel in ACS PCI patients. Major adverse cardiac events (MACE) at 90 days and at 1 year were defined as a composite of death, myocardial infarction, stroke, or unplanned revascularization. Clinically significant bleeding was defined as bleeding requiring transfusion or hospitalization. Cox regression multivariable analysis was performed for adjusted associations between CKD status and clinical outcomes. Hazard ratios for prasugrel versus clopidogrel treatment were generated using propensity score stratification. Results The total cohort included 19,832 patients, 28.3% with and 71.7% without CKD. CKD patients were older with greater comorbidities including diabetes and multivessel disease. Prasugrel was less often prescribed to CKD versus non-CKD patients (11.0% vs. 24.0%, respectively; p Conclusions Although risks for 1-year MACE were significantly higher in ACS PCI patients with versus without CKD, prasugrel use was 50% lower in patients with renal impairment. Irrespective of CKD status, outcomes associated with prasugrel use were not significant after propensity adjustment. These data highlight the need for randomized studies evaluating the optimal antiplatelet therapy in CKD patients with ACS.

BACKGROUND AND OBJECTIVES: We sought to determine the frequency of use and association between prasugrel and outcomes in acute coronary syndrome patients undergoing percutaneous coronary intervention (PCI) in clinical practice. METHODS: PROMETHEUS was a multicenter observational registry of acute coronary syndrome patients undergoing PCI from 8 centers in the United States that maintained a prospective PCI registry for patient outcomes. The primary end points were major adverse cardiovascular events at 90days, a composite of all-cause death, nonfatal myocardial infarction, stroke, or unplanned revascularization. Major bleeding was defined as any bleeding requiring hospitalization or blood transfusion. Hazard ratios (HRs) were generated using multivariable Cox regression and stratified by the propensity to treat with prasugrel. RESULTS: Of 19,914 patients (mean age 64.4years, 32% female), 4,058 received prasugrel (20%) and 15,856 received clopidogrel (80%). Prasugrel-treated patients were younger with fewer comorbid risk factors compared with their counterparts receiving clopidogrel. At 90days, there was a significant association between prasugrel use and lower major adverse cardiovascular event (5.7% vs 9.6%, HR 0.58, 95% CI 0.50-0.67, P

Background The potential benefit of long-term dual antiplatelet therapy (DAPT) for secondary prevention of atherothrombotic events is unclear. Data from different randomized controlled trials (RCT) using different agents in different subgroups showed inconsistent results. Methods We performed a systematic review and meta-analysis from RCTs that tested different prolonged durations of DAPT for secondary prevention. Long term DAPT arm was defined as those receiving DAPT for more than 12 months. Long-term aspirin arm was defined as those receiving either aspirin alone long term or DAPT for less than 12 months. Results The use of long term DAPT was associated with a significant decrease in composite of death, myocardial infarction (MI) and stroke (6.08% vs. 6.71%; odds ratio OR = 0.86 [0.78–0.94]; P = 0.001). This reduction of death, MI and stroke was mainly noticed in patients with prior MI or stroke, but not with PAD or multiple risk factors. The reduction was seen with post PCI patients with prasugrel and only in those with prior MI with clopidogrel and ticagrelor. Long-term use of DAPT was associated with significant increase in major bleeding (1.47% vs. 0.88%; OR = 1.65 [1.23–2.21]; P = 0.001). Conclusion Long-term use of DAPT for secondary prevention is associated with lower risk of death, MI and stroke beneficial especially in patients with prior MI and stroke, but it is associated with increased risk of bleeding. Prolonging DAPT requires careful assessment of the trade-off between ischemic and bleeding complications and should probably be reserved for patients with higher risk for atherothrombotic events.

Prasugrel is a potent thienopyridine that may be preferentially used in younger patients with lower bleeding risk.We compared prasugrel use and outcomes by age from the PROMETHEUS study. We also assessed age-related trends in treatment effects with prasugrel versus clopidogrel.PROMETHEUS was a multicenter acute coronary syndrome (ACS) percutaneous coronary intervention (PCI) registry. We compared patients in age tertiles (T1 60 years, T2 60-70 years, T3 70 years). Major adverse cardiac events (MACE) were a composite of death, myocardial infarction, stroke or unplanned revascularization. Data were adjusted using multivariable Cox regression for age-related risks and propensity score stratification for thienopyridine effects.The study included 19,914 patients: 7045 (35.0%) in T1, 6489 (33.0%) in T2 and 6380 (32.0%) in T3. Prasugrel use decreased from T1 to T3 (29.2% vs. 23.5% vs. 7.5%, p 0.001). Crude 1-year MACE rates were highest in T3 (17.4% vs. 16.8% vs. 22.7%, p 0.001), but adjusted risk was similar between the groups (p-trend 0.52). Conversely, crude incidence (2.8% vs. 3.8% vs. 6.9%, p 0.001) and adjusted bleeding risk were highest in T3 (HR 1.24, 95% CI 0.99-1.55 in T2; HR 1.83, 95% CI 1.46-2.30 in T3; p-trend 0.001; reference = T1). Treatment effects with prasugrel versus clopidogrel did not demonstrate age-related trends for MACE (p-trend = 0.91) or bleeding (p-trend = 0.28).Age is a strong determinant of clinical risk as well as prasugrel prescription in ACS PCI with much lower use among older patients. Prasugrel did not have a differential treatment effect by age for MACE or bleeding. Frequency of prasugrel use and age-related temporal risks of all-cause death and bleeding after ACS PCI.

Young women undergoing percutaneous coronary intervention (PCI) for acute coronary syndrome (ACS) experience greater adverse events than men, potentially due to under-treatment. We sought to compare the 1-year outcomes by sex in patients ≤55 years of age from a contemporary PCI cohort. : PROMETHEUS was a retrospective multicenter observational US study comparing outcomes in clopidogrel and prasugrel treated patients following ACS PCI. MACE was defined as a composite of death, myocardial infarction, stroke or unplanned revascularization. Clinically significant bleeding was defined as bleeding requiring transfusion or hospitalization. Hazard ratios were generated using multivariable Cox proportional hazards regression. : The study cohort included 4,851 patients of which 1,162 (24.0%) were women and 3,689 (76.0%) were men. In this cohort, the prevalence of diabetes (41.0 vs. 27.9%) and chronic kidney disease (12.7 vs. 7.2%) was higher among women compared with men. Irrespective of sex, prasugrel was used in less than one-third of patients (31.8% in men vs. 28.1% in women, P = 0.01). Unadjusted, 1-year MACE (21.1% vs. 16.2%, P : Women ≤ 55 years of age undergoing ACS PCI have significantly greater comorbidities than young men. Despite a higher risk clinical phenotype in women, prasugrel use was significantly lower in women than men. Female sex was associated with a significantly higher risk of 1-year MACE and bleeding than male sex, findings that are attributable to baseline differences. © 2016 Wiley Periodicals, Inc.

Objectives: To investigate the prevalence, predictors and associations between guideline-directed medical therapy (GDMT) and clinical outcomes in acute myocardial infarction (AMI) patients undergoing percutaneous coronary intervention (PCI) from eight academic centers in the United States. Background: Evidence for GDMT in patients with AMI comes from randomized controlled trials. The use of GDMT in clinical practice is unknown in this setting. Methods: PROMETHEUS is a multicenter observational registry comprising 19,914 patients with acute coronary syndrome (ACS) undergoing PCI. Patients with AMI were divided into two groups based on the prescription of GDMT or not (non-GDMT) at discharge. GDMT was defined according to American College of Cardiology/American Heart Association (ACC/AHA) class I recommendations, specifically, dual antiplatelet therapy, statin and beta-blocker for all AMI patients, and additional ACEI/ARB in patients with left ventricular ejection fraction (LVEF) less than 40%, hypertension, diabetes mellitus (DM) or chronic kidney disease (CKD). The primary endpoint was major adverse cardiovascular events (MACE) defined as a composite of all-cause death, MI, stroke or unplanned target vessel revascularization (TVR) at 1 year. Results: Out of 4,834 patients with AMI, 3,356 (69.4%) patients were discharged on GDMT. Patients receiving GDMT were more often younger and male. Compared with non-GDMT patients, GDMT patients had a significantly lower frequency of comorbidities. Predictors of greater GDMT prescription at discharge were ST-segment elevation myocardial infarction (STEMI), and increased body mass index (BMI), whereas hypertension, prior PCI, anemia and CKD were associated with less GDMT prescription. At 1 year, the use of GDMT was associated with a significantly lower incidence of MACE (13.7% vs. 22.5%; adjusted HR 0.68; 95%CI 0.58–0.80; P < 0.001), death (3.7% vs. 9.4%; adjusted HR 0.61; 95%CI 0.46–0.80; P < 0.001), and unplanned TVR (8.4% vs. 11.3%; adjusted HR 0.76; 95%CI 0.61–0.96; P = 0.020). However, there were no significant differences in the incidence of MI (4.3% vs. 7.0%; adjusted HR 0.75; 95%CI 0.56–1.01; P = 0.056), stroke (1.5% vs. 2.0%; adjusted HR 0.79; 95%CI 0.47–1.34; P = 0.384) between the two groups. Conclusion: In a contemporary practice setting in the United States, GDMT was utilized in just over two-thirds of AMI patients undergoing PCI. Predictors of GDMT prescription at discharge included STEMI, BMI and absence of hypertension, CKD, anemia or prior PCI. Use of GDMT was associated with significantly lower risk of 1-year MACE and mortality.

The field of interventional cardiology has undergone tremendous changes over the last 10 years, with advancement of the management pathways of both stable coronary artery disease and acute coronary syndrome and expansion in the volume of non-coronary interventions especially structural heart disease interventions. This chapter discusses the medical economics of interventional procedures in the current era.

Coronary angiography and revascularization began in the 1960s and has evolved dramatically into a robust platform for not only diagnosis of coronary disease but also complex intervention. The phenomenal number of procedures, over a million by the mid-2000s in the United States alone, has helped improve operator expertise. This coupled with advances in equipment, specifically in stent technology, has made percutaneous intervention an increasingly preferred modality in various clinical scenarios. With this, the world saw ever-increasing revascularization of coronary stenoses in patients ranging from those with asymptomatic lesions to those suffering an acute myocardial infarction. However, even though coronary intervention through both percutaneous coronary intervention and coronary artery bypass grafting have greatly improved outcomes in the setting of acute coronary syndrome, the same has not been systematically true for stable ischemic heart disease.

Middle Aortic Syndrome is a rare vascular disorder consisting of narrowing or stenosis of the distal thoracic or abdominal aorta. It is described in the literature in the form of case studies and case series. The authors present an unusual case of Middle Aortic Syndrome attributed to Takayasu’s arteritis in a 60-year-old female who presented to the emergency department with uncontrolled hypertension. Traditional intervention involves open surgical bypass. This case study reviews the published literature on this rare syndrome and illustrates a successful alternative to open surgery through an endovascular approach.

The planning of revascularization strategy for multivessel coronary artery disease (CAD) in nondiabetic patients is optimally made through considering the goals of improving survival and/or relieving symptoms. Existing clinical practice guidelines and appropriate use criteria [(1–3)][1] state

Acute coronary syndromes (ACS) are associated with high rates of morbidity and mortality. The advances of antiplatelet and anticoagulation therapy over several years time have resulted in improved in cardiac outcomes, but with increased health care costs. Multiple cost-effectiveness studies have been performed to evaluate the use of available antiplatelet agents and anticoagulation in the setting of both ST-segment elevation myocardial infarction (STEMI) and non-ST-segment elevation acute coronary syndrome (NSTE-ACS). Early on, the use of glycoprotein IIb/IIIa receptor inhibitors (GPIs) proved to be economically attractive in the management of ACS; however, the introduction of P2Y12 receptor antagonists limited their use to a bail out agents in complex interventions. Generic clopidogrel is probably still an economically attractive P2Y12 receptor antagonist choice, especially in low-risk ACS, while both ticagrelor and prasugrel present an economically attractive alternative option, especially in high-risk ACS and patients at risk for stent thrombosis. While enoxaparin presents an economically dominant alternative to heparin in NSTE-ACS, its role in STEMI in the contemporary era is unclear. During percutaneous coronary intervention (PCI), bivalirudin monotherapy was shown to be an economically dominant alternative to the combination of heparin and GPI in ACS. However, new studies may suggest that using heparin monotherapy may offer an attractive alternative. The comparative and cost effectiveness of different combinations of antiplatelet and antithrombotic therapy will be the focus of future expected clinical and economic assessments.

article i nfo Percutaneous coronary intervention Coronary artery bypass grafting Drug eluting stents Randomized control trials Objective: To compare outcomes of percutaneous coronary intervention (PCI) with drug eluting stent (DES) and Coronary Artery Bypass Grafting (CABG) in patients with multivessel Coronary Artery Disease (CAD) using data from randomized controlled trials (RCT). Background: PCI and CABG are established strategies for coronary revascularization in the setting of ischemic heart disease. Multiple RCTs have compared outcomes of the two modalities in patients with multivessel CAD. Methods: We did a meta-analysis from six RCTs in the contemporary era comparing the effectiveness of PCI with DES to at 1 year, 2 years and 5 years respectively. Results: Compared to CABG, at one year PCI was associated with a significantly higher incidence of TVR (RR = 2.31; 95% CI: (1.80-2.96); P = b0.0001), lower incidence of stroke (RR = 0.35; 95% CI: (0.19-0.62); P = 0.0003), and no difference in death (RR = 1.02; 95% CI: (0.77-1.36); P = 0.88) or MI (RR = 1.16; 95% CI: (0.72-1.88); P = 0.53). At 5 years, PCI was associated with a higher incidence of death (RR = 1.3; 95% CI: (1.10-1.54); P = 0.0026) and MI (RR = 2.21; 95% CI: (1.75-2.79); P = b0.0001). While the higher incidence of MI with PCI was noticed in both diabetic and non-diabetics, death was increased mainly in diabetic patients. Conclusion:Inpatientswithmulti-vesselCAD,PCIwithDESisassociatedwithnosignificantdifferenceindeathor MI at 1 or 2 years. However at 5 years, PCI is associated with higher incidence of death and MI.

Objectives Coronary artery bypass grafting (CABG) was found to be the preferred strategy of revascularization in patients with diabetes in the bare-metal stent (BMS) era. The introduction of drug-eluting stents (DESs) led to a significant reduction in the rates of repeat revascularization (RRV) when compared with BMSs. We did a collaborative analysis of data from randomized controlled trials in the contemporary era to compare CABG versus percutaneous coronary intervention using DESs in diabetic patients. Methods We performed a systematic review and meta-analysis from randomized trials in the contemporary era comparing PCI with DESs with CABG in diabetic patients with multivessel disease. A comprehensive literature search (1 January 2003 to 18 May 2013) identified randomized controlled trials that reported long-term outcomes comparing PCI using DESs with CABG in 2974 diabetic patients. Results At 1 year, PCI was associated with a significant increase in the incidence of RRV [2.48 (1.56-3.94); P ≤0.0001], lower incidence of stroke [relative risk (RR) = 0.43 (0.19-0.81); P = 0.017], and no difference in death or myocardial infarction (MI). At 5 years, PCI was still associated with a lower incidence of stroke, but was associated with a significant increase in the incidence of death [RR = 1.36 (1.11-1.66); P = 0.0033] and MI [RR = 2.01 (1.54-2.62); P ≤0.0001]. Conclusions In patients with diabetes, PCI was associated with no difference in death and MI at 1 year. However, at 5 years, PCI was associated with a higher incidence of death and MI. PCI was associated with a higher incidence of RRV but a lower incidence of stroke.

Platelet functional testing has been available to clinicians for several decades. Despite certain limitations, it has proven useful in several arenas, including diagnosing bleeding disorders, assessment of platelet-derived hemostasis and for monitoring response to antiplatelet medication. Special attention has recently been paid to high residual platelet reactivity in patients undergoing percutaneous coronary interventions and being treated with antiplatelet medications, largely because of the increased risk of major cardiovascular events and stent thrombosis. In keeping with this, determining high residual platelet reactivity in patient appropriately taking aspirin and P2Y12 inhibitor therapy has focused attention on tests aimed at diagnosing poor antiplatelet, and specifically clopidogrel response. Based on this, attempts to predict and intervene on poor response and its potential outcomes are prominent in the current literature, with the assistance of both platelet functional analysis and genetic deter...

BACKGROUND: The in vitro quality of small-volume platelet (PLT) aliquots for pediatric transfusions was assessed to determine the best practice approach. STUDY DESIGN AND METHODS: Small volumes (50 mL) of single apheresis PLT components (APCs), collected on either CaridianBCT Trima or Haemonetics MCS+ instruments, were aliquoted on Days 2, 3, 4, and 5 postcollection into Fenwal PL1240 or 4R2014 bags or 60-mL polypropylene syringes. Samples were tested for in vitro quality at their recommended expiry times (4 hr for 4R2014 bags and syringes or Day 5 for PL1240 bags). Assays included pH, CD62P expression, and metabolic measures. RESULTS: CD62P expression increased throughout storage in all containers. Among the small-volume containers, pH, pCO2, lactate, and bicarbonate varied considerably. Regardless of the day of aliquoting, pCO2 was significantly higher and pO2 was significantly lower in gas-impermeable syringes than other containers. No bacterial growth was detected in any sample. CONCLUSION: The quality of APCs aliquoted into small-volume containers meets regulatory requirements and is generally equivalent to that of full-volume APCs at expiry.

BACKGROUND: With buffy coat (BC) processing of whole blood (WB) donations, the preparation of plasma occurs within 24 hours rather than 8 hours of collection. The effect of this change on coagulation factor function in plasma and cryoprecipitate was evaluated during the validation of this production method and with routine production. STUDY DESIGN AND METHODS: Plasma frozen after an overnight hold of WB was prepared via BC or whole blood filtration (WBF) methods and quality control (QC) variables were measured. Additionally, plasma prepared with the BC method was compared to plasma produced using the platelet-rich plasma (PRP) method with an extended plasma factor analysis. Selected plasma factor levels were also measured in both cryoprecipitate and cryosupernatant plasma prepared using the WBF method from plasma frozen on the day of collection or after an overnight hold of WB. RESULTS: When comparing BC plasma to PRP plasma, coagulation factors (F)II, VII, VIII, IX, X, and XI had somewhat lower levels, and fibrinogen and antithrombin levels were elevated. As expected the most sensitive to the prolongation of production time was FVIII with 72 and 78% of the activity of PRP plasma and cryoprecipitate, respectively. However, both still met QC standards. Similarly, products made in routine production show acceptable levels of FVIII. CONCLUSION: Plasma and cryoprecipitate products, prepared using methods in which the plasma is frozen close to 24 hours after collection, meet current quality standards. The longer WB storage time has been implemented into general use in Canada.

BACKGROUND: In high-volume processing environments, manual breakage of in-line closures can result in repetitive strain injury (RSI). Furthermore, these closures may be incorrectly opened causing shear-induced hemolysis. To overcome the variability of in-line closure use and minimize RSI, Fresenius Kabi developed a new in-line closure, the CompoFlow, with mechanical openers. STUDY DESIGN AND METHODS: The consistency of the performance of the CompoFlow closure device was assessed, as was its effect on component quality. A total of 188 RBC units using CompoFlow blood bag systems and 43 using the standard bag systems were produced using the buffy coat manufacturing method. Twenty-six CompoFlow platelet (PLT) concentrates and 10 control concentrates were prepared from pools of four buffy coats. RBCs were assessed on Days 1, 21, and 42 for cellular variables and hemolysis. PLTs were assessed on Days 1, 3, and 7 for morphology, CD62P expression, glucose, lactate, and pH. A total of 308 closures were excised after processing and the apertures were measured using digital image analysis. RESULTS: The use of the CompoFlow device significantly improved the mean extraction time with 0.46 ± 0.11 sec/mL for the CompoFlow units and 0.52 ± 0.13 sec/mL for the control units. The CompoFlow closures showed a highly reproducible aperture after opening (coefficient of variation, 15%) and the device always remained opened. PLT and RBC products showed acceptable storage variables with no differences between CompoFlow and control. CONCLUSIONS: The CompoFlow closure devices improved the level of process control and processing time of blood component production with no negative effects on product quality.

The keynote COURAGE and BARI-2D trials changed the way the interventional community selects patients for revascularization. What we now consider appropriate, especially for percutaneous coronary intervention, has narrowed significantly in scope compared to previous practice a decade ago. Medical therapy has been shown to be both safe and effective as a primary treatment modality for patients with stable ischemic heart disease on the whole. However, it appears that patients with a heavy ischemic burden may benefit from revascularization, although investigation of this is ongoing. Evidence preliminarily supports this practice with coronary artery bypass grafting, and possibly in specific populations undergoing multivessel intervention with functional assessment of lesion severity during PCI.

With the increasing proportion of elderly patients in the population, physicians are often faced with challenging treatment decisions for the management of coronary artery diseases, valvular heart diseases, advanced heart failure and prevention of sudden cardiac death in the elderly patient population. Comprehensive review of the literature and available evidence is summarized in this chapter to guide such complex clinical decisions. Elderly patients presenting with an acute coronary syndrome (ACS) appear to benefit from percutaneous coronary intervention (PCI) with the use of drug eluting stents (DES). Though current guidelines do not consider age as a prohibitive factor, the risk of major bleeding complications and stroke should be carefully considered. For elderly patients with severe aortic stenosis, trans-catheter aortic valve replacement (TAVR) is superior compared to medical therapy for inoperable patients. TAVR, when performed via the transfemoral approach, remains non inferior and cost effective compared to surgical aortic valve replacement (SAVR). Trans-catheter mitral valve repair (TMVR) using MitraClip appears to be beneficial for inoperable patients with degenerative severe mitral regurgitation but more data are needed. Implantable cardioverter defibrillator (ICD) implantation in the elderly population remains a controversial topic especially for secondary prevention. The current evidence suggests that age should not be the sole withholding factor but the decision for ICD implantation should account for comorbidities and patient preference. On the other hand, cardiac resynchronization therapy (CRT) has definitely a mortality and morbidity benefit in the management of elderly patients with advanced heart failure.

While overall mortality in cardiovascular disease has declined, some groups such as females with diabetes are still at increased risk for worse outcome after ACS. We aimed to compare 1-year outcomes between female and male ACS patients after PCI stratified by the presence of diabetes mellitus (DM

Bleeding is a risk of potent antiplatelet therapy. Anemia is associated with increased bleeding. We sought to examine the rates of prasugrel use, thienopyridine switching and clinical outcomes by presence of anemia in contemporary percutaneous coronary intervention (PCI) for acute coronary syndrome

We report a case of a patient with pulmonary hypertension who presented with acute hypoxemic respiratory failure. The patient had continued refractory hypoxemia despite a prolonged ICU admission that included ventilatory support, and empiric therapy for pulmonary embolism and pneumonia. Transthoracic echocardiography (TTE) revealed a patent foramen ovale (PFO), which after percutaneous closure resulted in profound improvement in hypoxemia and clinical status.

Stent length is an independent risk factor for adverse cardiovascular events after percutaneous coronary intervention (PCI) with first generation drug eluting stents (DES). We examined the associations between stent length and clinical events in patients treated with second generation DES.

Background: Multivessel (MV) disease is present in a significant number of patients with non-ST-segment elevation myocardial infarction (NSTEMI). The optimal revascularization strategy in these patients is uncertain. Methods: PROMETHEUS was a multicenter observational study of patients undergoing

Background: African American (AA) patients are at high risk for adverse cardiovascular outcomes after PCI, thus providing a rationale for use of potent P2Y12 inhibitors in such individuals. However, whether or not race is a determinant of prasugrel versus clopidogrel use in acute coronary syndrome (

Although it has been almost 20 years since the first case of Takotsubo cardiomyopathy was described in Japan, its pathophysiology remains an enigma. While several hypotheses have been proposed to explain the pathophysiology, the exact mechanism of the syndrome is unknown. This editorial reviews the literature published on various theories on the pathophysiology of Takotsubo cardiomyopathy.

In suspected ACS, new or presumed new LBBB (n/pnLBBB) is considered as acute STEMI equivalent. At our large academic medical center, we sought to compare the in-hospital mortality of patients presenting with suspected ACS and having n/pn LBBB verses known LBBB (kLBBB). We reviewed records of all

Percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) are established strategies for coronary revascularization in the setting of ischemic heart disease. Multiple randomized controlled trials and observational studies have compared the impact of the two modalities on the patients’ quality of life, mortality and morbidity, as well as the cost–effectiveness of these modalities in different clinical setting. CABG is the preferred strategy for revascularizations in patients with multi-vessel disease, especially in those with higher risk secondary to associated diabetes, left ventricular dysfunction or more complex lesions. PCI is a reasonable revascularization modality in patients with ischemia and single or low-risk multi-vessel disease and those with unprotected left main with low complexity anatomy. Compared with PCI, CABG is associated with less repeat revascularization, better quality of life and improved survival in high-risk patients. Although CABG is associated with higher cost, it is probably associated with a reasonable cost per quality-adjusted life-year gained in many patients. Therefore, CABG will often be a cost-effective strategy, especially in patients with high angiographic complexity and/or diabetes.

The determinants of clinical decision-making for potent platelet inhibition with prasugrel versus clopidogrel in real-world patients with acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI) remain poorly characterized. The purpose of this study was to identify factors

The contemporary incidence, associated factors and implications of stroke after acute coronary syndromes (ACS) managed with percutaneous coronary intervention (PCI) and novel antiplatelet drugs is unknown. We sought to characterize the incidence, predictors and impact of stroke on subsequent

The potential benefit of long-term dual antiplatelet therapy (DAPT) for secondary prevention of atherothrombotic events in patients with coronary artery disease (CAD) is unclear. Data from different randomized controlled trials (RCT) using different agents in different subgroups showed inconsistent

Diastolic compression of the coronary arteries is a rare and likely acquired finding. Previous reports hypothesized that the artery becomes compressed against epicardial and pericardial scarring during ventricular filling, which leads to reduced coronary blood flow and clinical ischemia. We present two cases of isolated diastolic coronary artery compression resulting from contact against postoperative pericardial reflections that became calcified during the course of 10 to 20 years.