Faculty Bibliography

OBJECTIVES/OBJECTIVE:To assess the current use and application of simulators in interventional cardiology. BACKGROUND:Despite a paucity of data on the efficacy of simulation in medicine, cardiovascular simulation training is now a mandated part of cardiovascular fellowship training. Additionally, simulators have been endorsed by the Food and Drug Administration as a way to teach physicians new and novel procedures. We sought to establish the current use of simulators in cardiovascular medicine. METHODS:A systematic review was done of available training programs, and currently existing data regarding simulation training. A panel of experts was convened to review this data and provide recommendations as how simulation should be used in the field of interventional cardiology. RESULTS:This document provides a comprehensive review of the current state of simulation and how we as a society must formulate well validated studies to more closely examine and explore how this technology can be further studied and validated. CONCLUSIONS:Simulation will likely take on a larger role in cardiovascular training and maintenance of certification, but at the current time lacks a large body of evidence for its use.

BACKGROUND:Several percutaneous coronary intervention (PCI) trials have established that the use of bivalirudin (BIV) is associated with improved patient outcomes and substantial hospital cost savings, relative to heparin (HEP)-based regimens±glycoprotein IIb/IIIa inhibitors (GPIs). Whether these benefits persist with the use of prasugrel, a new third-generation oral thienopyridine, has not been previously evaluated. METHODS:Using the Premier hospital database, 6986 patients treated with prasugrel who underwent elective, urgent, or primary PCI between quarter 3, 2009 and quarter 4, 2010 from 166 US hospitals were identified. These patients received either BIV (n=3377) or HEP±GPI (n=3609) as procedural anticoagulation. Outcomes of interest included bleeding, transfusions, death, and hospital length of stay (LOS). To control for patient and hospital-level characteristics, propensity score-matching (PSM) analyses were performed. RESULTS:Mortality, clinically apparent bleeding, clinically apparent bleeding requiring transfusion, any transfusions, and LOS were all lower in patients treated with BIV as compared with patients treated with HEP±GPI. After PSM, the rate of transfusion was significantly lower with BIV (odds ratio: 0.57, 95% confidence interval: 0.34-0.96), and the hospital LOS was significantly shorter in patients treated with BIV compared with those treated with HEP±GPI (0.9±2.0 vs 1.2±2.3 days, P<0.0001). CONCLUSIONS:In patients undergoing PCI and treated with prasugrel, the use of BIV rather than HEP±GPI is associated with significantly lower transfusion rate and LOS. These results suggest that the previously documented safety and cost-effectiveness benefits of BIV remain applicable when prasugrel is used.

OBJECTIVES:To examine the relationship between periprocedural bleeding complications and major adverse cardiovascular events (MACEs) and mortality outcomes following percutaneous coronary intervention (PCI) and study differences in the prognostic impact of different bleeding definitions. METHODS:We conducted a systematic review and meta-analysis of PCI studies that evaluated periprocedural bleeding complications and their impact on MACEs and mortality outcomes. A systematic search of MEDLINE and EMBASE was conducted to identify relevant studies. Data from relevant studies were extracted and random effects meta-analysis was used to estimate the risk of adverse outcomes with periprocedural bleeding. Statistical heterogeneity was assessed by considering the I(2) statistic. RESULTS:42 relevant studies were identified including 533 333 patients. Meta-analysis demonstrated that periprocedural major bleeding complications was independently associated with increased risk of mortality (OR 3.31 (2.86 to 3.82), I(2)=80%) and MACEs (OR 3.89 (3.26 to 4.64), I(2)=42%). A differential impact of major bleeding as defined by different bleeding definitions on mortality outcomes was observed, in which the REPLACE-2 (OR 6.69, 95% CI 2.26 to 19.81), STEEPLE (OR 6.59, 95% CI 3.89 to 11.16) and BARC (OR 5.40, 95% CI 1.74 to 16.74) had the worst prognostic impacts while HORIZONS-AMI (OR 1.51, 95% CI 1.11 to 2.05) had the least impact on mortality outcomes. CONCLUSIONS:Major bleeding after PCI is independently associated with a threefold increase in mortality and MACEs outcomes. Different contemporary bleeding definitions have differential impacts on mortality outcomes, with 1.5-6.7-fold increases in mortality observed depending on the definition of major bleeding used.

OBJECTIVES/OBJECTIVE:This study sought to examine whether rates of inappropriate percutaneous coronary intervention (PCI) differ by demographic characteristics and insurance status. BACKGROUND:Prior studies have found that blacks, women, and those who have public or no health insurance are less likely to undergo PCI. Whether this reflects potential overuse in whites, men, and privately insured patients, in addition to underuse in disadvantaged populations, is unknown. METHODS:Within the National Cardiovascular Data Registry CathPCI Registry, we identified 221,254 nonacute PCIs performed between July 2009 and March 2011. The appropriateness of PCI was determined using the Appropriate Use Criteria for coronary revascularization. Multivariable hierarchical regression was used to evaluate the association between patient demographics and insurance status and inappropriate PCI, as defined by the Appropriate Use Criteria. RESULTS:Of 211,254 nonacute PCIs, 25,749 (12.2%) were classified as inappropriate. After multivariable adjustment, men (adjusted odd ratio [OR]: 1.08 [95% CI: 1.05 to 1.11]; p < 0.001) and whites (adjusted OR: 1.09 [95% CI: 1.05 to 1.14]; p < 0.001) were more likely to undergo an inappropriate PCI in comparison with women and nonwhites. Compared with privately insured patients, those who had Medicare (adjusted OR: 0.85 [95% CI: 0.83 to 0.88]), other public insurance (adjusted OR: 0.78 [95% CI: 0.73 to 0.83]), and no insurance (adjusted OR: 0.56 [95% CI: 0.50 to 0.61]) were less likely to undergo an inappropriate PCI (p < 0.001). In addition, compared with urban hospitals, those admitted at rural hospitals were less likely to undergo inappropriate PCI, whereas those at suburban hospitals were more likely. CONCLUSIONS:For nonacute indications, PCIs categorized as inappropriate were more commonly performed in men, whites, and those who had private insurance. Higher rates of PCI in these patient populations may, in part, be due to procedural overuse.

Dual antiplatelet therapy with aspirin and a P2Y12 receptor blocker is a key strategy to reduce platelet reactivity and to prevent thrombotic events in patients treated with percutaneous coronary intervention. In an earlier consensus document, we proposed cutoff values for high on-treatment platelet reactivity to adenosine diphosphate (ADP) associated with post-percutaneous coronary intervention ischemic events for various platelet function tests (PFTs). Updated American and European practice guidelines have issued a Class IIb recommendation for PFT to facilitate the choice of P2Y12 receptor inhibitor in selected high-risk patients treated with percutaneous coronary intervention, although routine testing is not recommended (Class III). Accumulated data from large studies underscore the importance of high on-treatment platelet reactivity to ADP as a prognostic risk factor. Recent prospective randomized trials of PFT did not demonstrate clinical benefit, thus questioning whether treatment modification based on the results of current PFT platforms can actually influence outcomes. However, there are major limitations associated with these randomized trials. In addition, recent data suggest that low on-treatment platelet reactivity to ADP is associated with a higher risk of bleeding. Therefore, a therapeutic window concept has been proposed for P2Y12 inhibitor therapy. In this updated consensus document, we review the available evidence addressing the relation of platelet reactivity to thrombotic and bleeding events. In addition, we propose cutoff values for high and low on-treatment platelet reactivity to ADP that might be used in future investigations of personalized antiplatelet therapy.

BACKGROUND:The role of intraaortic balloon pump (IABP) during percutaneous coronary intervention (PCI) in high-risk acute patients remains debated. Device-related complications and the more complex patient management could explain such lack of clinical benefit. We aimed to assess the impact of transradial versus transfemoral access for PCI requiring IABP support on vascular complications and clinical outcome. METHODS:We retrospectively analyzed 321 consecutive patients receiving IABP support during transfemoral (n = 209) or transradial (n = 112) PCI. Thirty-day net adverse clinical events (NACEs) (composite of postprocedural bleeding, cardiac death, myocardial infarction, target lesion revascularization, and stroke) were the primary end point, with access-related bleeding and hospital stay as secondary end points. RESULTS:Cardiogenic shock and hemodynamic instability were the most common indications for IABP support. Cumulative 30-day NACE rate was 50.2%, whereas an access site-related bleeding occurred in 14.3%. Patients undergoing transfemoral PCI had a higher unadjusted rate of NACEs when compared with the transradial group (57.4% vs 36.6%, P < .01), mainly due more access-related bleedings (18.7% vs 6.3%, P < .01). Such increased risk of NACEs was confirmed after propensity score adjustment (hazard ratio 0.57 [0.4-0.9], P = .007), whereas hospital stay appeared comparable in the 2 groups. CONCLUSIONS:In this observational registry, high-risk patients undergoing PCI and requiring IABP support appeared to have fewer NACEs if transradial access was used instead of transfemoral, mainly due to fewer access-related bleedings. Given the inherent limitations of this retrospective work, including the inability to adjust for unknown confounders, further controlled studies are warranted to confirm or refute these findings.

OBJECTIVES/OBJECTIVE:The aim of this study was to describe usage of the wearable cardioverter-defibrillator (WCD) during mandated waiting periods following myocardial infarction (MI) for patients perceived to be at high risk for sudden cardiac arrest (SCA). BACKGROUND:Current device guidelines and insurance coverage require waiting periods of either 40 days or 3 months before implanting a cardioverter-defibrillator post-myocardial infarction (MI), depending on whether or not acute revascularization was undertaken. METHODS:We assessed characteristics of and outcomes for patients who had a WCD prescribed in the first 3 months post-MI. The WCD medical order registry was searched for patients who were coded as having had a "recent MI with ejection fraction ≤35%" or given an International Classification of Diseases, Ninth Revision 410.xx diagnostic code (acute MI), and then matched to device-recorded data. RESULTS:Between September 2005 and July 2011, 8,453 unique patients (age 62.7 ± 12.7 years, 73% male) matched study criteria. A total of 133 patients (1.6%) received 309 appropriate shocks. Of these patients, 91% were resuscitated from a ventricular arrhythmia. For shocked patients, the left ventricular ejection fraction (LVEF) was ≤30% in 106, 30% to 35% in 17, >36% in 8, and not reported in 2 patients. Of the 38% of patients not revascularized, 84% had a LVEF ≤30%; of the 62% of patients revascularized, 77% had a LVEF ≤30%. The median time from the index MI to WCD therapy was 16 days. Of the treated patients, 75% received treatment in the first month, and 96% within the first 3 months of use. Shock success resulting in survival was 84% in nonrevascularized and 95% in revascularized patients. CONCLUSIONS:During the 40-day and 3-month waiting periods in patients post-MI, the WCD successfully treated SCA in 1.4%, and the risk was highest in the first month of WCD use. The WCD may benefit individual patients selected for high risk of SCA early post-MI.

Erythropoietin (EPO) was hypothesized to mitigate reperfusion injury, in part via mobilization of endothelial progenitor cells (EPCs). The REVEAL trial found no reduction in infarct size with a single dose of EPO (60,000 U) in patients with ST-segment elevation myocardial infarction. In a substudy, we aimed to determine the feasibility of cryopreserving and centrally analyzing EPC levels to assess the relationship between EPC numbers, EPO administration, and infarct size. As a prespecified substudy, mononuclear cells were locally cryopreserved before as well as 24 and 48-72 h after primary percutaneous coronary intervention. EPC samples were collected in 163 of 222 enrolled patients. At least one sample was obtained from 125 patients, and all three time points were available in 83 patients. There were no significant differences in the absolute EPC numbers over time or between EPO- and placebo-treated patients; however, there was a trend toward a greater increase in EPC levels from 24 to 48-72 h postintervention in patients receiving ≥30,000 U of EPO (P = 0.099 for CD133(+) cells, 0.049 for CD34(+) cells, 0.099 for ALDH(br) cells). EPC numbers at baseline were inversely related to infarct size (P = 0.03 for CD133(+) cells, 0.006 for CD34(+) cells). Local whole cell cryopreservation and central EPC analysis in the context of a multicenter randomized trial is feasible but challenging. High-dose (≥30,000 U) EPO may mobilize EPCs at 48-72 h, and baseline EPC levels may be inversely associated with infarct size.