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A concept of "all or nothing" inspired the innovation of a one-pill-once-daily HIV treatment. Atripla® was the one pill that combined efavirenz, emtricitabine, and tenofovir disoproxil fumarate to become the first daily single tablet regimen that forever simplified HIV treatment to enhance patient compliance and thus, sustained viral suppression. The making of Atripla incorporated dry granulation and bilayer compression technologies to achieve stability and bioequivalence in an optimal pill size. In 2011, there lacked a standard of care for chronic hepatitis C infections that was safe, simple, short, free of interferon and ribavirin, and with high cure rates. A fixed-dose combination of ledipasvir and sofosbuvir was developed and approved in 2014 to be the first complete daily single tablet regimen for CHC genotype 1 infection. A spray-drying process for particle morphology engineering in a polymer matrix was used for improving bioavailability.

Attachment styles hold important downstream consequences for mental health through their contribution to the emergence of self-criticism. To date, no work has extended our understanding of the influence of attachment styles on self-criticism at a neurobiological level. Herein we investigate the relationship between self-reported attachment styles and neural markers of self-criticism using fMRI. A correlation network analysis revealed lingual gyrus activation during self-criticism, a marker of visual mental imagery, correlated with amygdala activity (threat response). It also identified that secure attachment positively correlated with lingual gyrus activation, whilst avoidant attachment was negatively correlated with lingual gyrus activation. Further, at greater levels of amygdala response, more securely attached individuals showed greater lingual gyrus activation, and more avoidantly attached individuals showed less lingual gyrus activation. Our data provide the first evidence that attachment mechanisms may modulate threat responses and mental imagery when engaging in self-criticism, which have important clinical and broader social implications.

When a fingerprint is located at a crime scene, a human examiner is counted upon to manually compare this print to those stored in a database. Several experiments have now shown that these professional analysts are highly accurate, but not infallible, much like other fields that involve high-stakes decision-making. One method to offset mistakes in these safety-critical domains is to distribute these important decisions to groups of raters who independently assess the same information. This redundancy in the system allows it to continue operating effectively even in the face of rare and random errors. Here, we extend this "wisdom of crowds" approach to fingerprint analysis by comparing the performance of individuals to crowds of professional analysts. We replicate the previous findings that individual experts greatly outperform individual novices, particularly in their false-positive rate, but they do make mistakes. When we pool the decisions of small groups of experts by selecting the decision of the majority, however, their false-positive rate decreases by up to 8% and their false-negative rate decreases by up to 12%. Pooling the decisions of novices results in a similar drop in false negatives, but increases their false-positive rate by up to 11%. Aggregating people's judgements by selecting the majority decision performs better than selecting the decision of the most confident or the most experienced rater. Our results show that combining independent judgements from small groups of fingerprint analysts can improve their performance and prevent these mistakes from entering courts.

We assessed whether intravascular ultrasound (IVUS) can detect evidence of coronary perforation that is not visible by coronary angiography. Approximately 15,000 consecutive percutaneous coronary interventions (PCI) performed with IVUS guidance were reviewed retrospectively, pre- and post-PCI IVUS images were compared, and IVUS findings were compared with coronary angiography and in-hospital outcomes. We detected three distinct patterns that were not present pre-PCI and that were suggestive of perforation or perivascular trauma: perivascular blood speckle in 67 % (51/76), perivascular hematoma in 17 % (13/76), and new echolucent perivascular layer in 16 % (12/76). Angiographic appearance included perforation in 24 % (18/76), dissection in 33 % (25/76), lumen irregularity in 17 % (13/76), new stenosis in 5 % (4/76), and no abnormalities in 21 % (16/76). The site of a break in arterial wall with communication between the lumen and perivascular space could be detected in 61 % (46/76). This extended proximally and distally with equal frequency, but was primarily located within the lesion in 80 % (61/76), although the lumen was rarely compromised. Within 24 h, there were four emergent coronary artery bypass grafting procedures, one repeat PCI, and six periprocedural myocardial infarctions (defined as CK-MB ≥10 times the upper limit of normal), but there were no episodes of cardiac tamponade. Although infrequent, IVUS detected three distinct patterns of post-PCI perivascular trauma suggestive of a perforation that was detected angiographically in only 24 % of cases.

Re-operation after coronary artery bypass grafting (CABG) is associated with increased risk for morbidity and mortality. Transcatheter aortic valve implantation (TAVI) is an alternative for patients with aortic stenosis, but the outcomes of patients with a history of CABG are unknown. The aim of this study was to explore the association between previous CABG and the outcome of patients undergoing TAVI. Out of 372 consecutive patients who underwent TAVI from 2007 to 2013, 122 (32.8%) had previous CABG, whereas 250 (67.2%) did not. A comparison was made between groups. Subgroup analysis compared patients with and without previous CABG in 3 patient subsets: inoperable, operable, and those who underwent transapical TAVI. Patients with previous CABG were younger (81.99±6.78 vs 84.81±7.06 years, respectively, p<0.001). These patients also had more high-risk features (e.g., peripheral vascular disease, previous myocardial infarction, past cerebrovascular disease, and lower average left ventricular ejection fraction (p<0.05 for all). Procedural aspects were mostly similar between groups. No disparities in mortality rates at 1 year were noted (22.1% vs 21.6%, respectively, p=0.91). Subgroup analyses yielded similar outcomes for all 3 groups. In conclusion, although patients with previous CABG present with more high-risk features, they share similar short- and long-term outcomes with patients without previous CABG, irrespective of their surgical risk. This includes patients who underwent transapical access. TAVI in patients with previous CABG is safe and does not confer a significant risk for adverse outcome., (Copyright © 2014 Elsevier Inc. All rights reserved.)

An article titled "Current issues in dermatologic office-based surgery" was published in the JAAD in October 1999 (volume 41, issue 4, pp. 624-634). The article was developed by the Joint American Academy of Dermatology/American Society for Dermatologic Surgery Liaison Committee. A number of subjects were addressed in the article including surgical training program requirements for dermatology residents and selected advances in dermatologic surgery that had been pioneered by dermatologists. The article concluded with sections on credentialing, privileging, and accreditation of office-based surgical facilities. Much has changed since 1999, including more stringent requirements for surgical training during dermatology residency, and the establishment of 57 accredited Procedural Dermatology Fellowship Training Programs. All of these changes have been overseen and approved by the Residency Review Committee for Dermatology and the Accreditation Committee for Graduate Medical Education. The fertile academic environment of academic training programs with interaction between established dermatologic surgeons and fellows, as well as the inquisitive nature of many of our colleagues, has led to the numerous major advances in dermatologic surgery, which are described herein., (Copyright © 2013 American Academy of Dermatology, Inc. Published by Mosby, Inc. All rights reserved.)

The safety and efficacy outcomes of stent overlap with second-generation drug-eluting stents (DES) have not been well established. This study aimed to compare the 1-year clinical outcomes of overlapping everolimus-eluting stents (EES) with those of overlapping first-generation DES. This retrospective analysis included 350 patients treated with overlapping EES (169 patients with 237 lesions), sirolimus-eluting stents (SES, 102 patients with 252 lesions), or paclitaxel-eluting stents (PES, 79 patients with 182 lesions). End points were major adverse cardiovascular events (MACE: defined as the composite of death, myocardial infarction, or target lesion revascularization), target vessel revascularization, and definite stent thrombosis at 1 year. During a follow-up of 1 year, overall MACE occurred in 6.5% of EES-, 16.8% of SES-, and 10.1% of PES-treated patients (p = 0.026). Myocardial infarction was lowest in the EES group versus SES and PES groups (0 vs 1.0% vs 2.5%, respectively; p = 0.080), and mortality was similar (3.6% vs 9.0% vs 5.1%, p = 0.162). The EES patients showed a trend toward lower rates of 1-year target lesion revascularization (3.1% vs 8.2% vs 6.5%, p = 0.181) and target vessel revascularization (3.7% vs 9.1% vs 11.7%, p = 0.051) compared with the SES- and PES-treated patients. The cumulative incidence of definite stent thrombosis was lowest in the EES group (0 for EES vs 3.9% for SES vs 2.5% for PES, p = 0.014). In conclusion, stent overlap with EES versus first-generation DES was associated with lower rates of MACE and stent thrombosis. Our results suggest that the use of EES when deploying overlapping stents is effective and safe., (Copyright © 2013 Elsevier Inc. All rights reserved.)

One of the major dilemmas facing physicians is what diagnostic and therapeutic approaches should be recommended to those stable coronary artery disease patients whose symptoms are adequately controlled on medical therapy. This study sought to assess the evidence-based data relating to whether: 1) all patients with significant coronary lesions (i.e., ischemia-producing) should undergo percutaneous coronary intervention (PCI); 2) the best therapeutic approach is optimal medical therapy; or 3) PCI should be performed, but only in certain subsets of patients. We reviewed all recent meta-analyses of prospective randomized trials that compared the outcomes of medical therapy and PCI in stable, symptomatically controlled, coronary artery disease patients. To provide greater insights to the clinician, we then analyzed, in depth, 3 comprehensive and widely quoted randomized trials. Review of recently published (2012) meta-analyses, and the detailed analyses of 3 widely quoted individual studies, indicate no difference exists between PCI and medical therapy in nonfatal MI or in all-cause or cardiovascular mortality. Thus, clinical equipoise exists: in other words, there is no evidence-based justification for adopting 1 therapeutic strategy over the other. Therefore, it is not inappropriate, until additional evidence emerges, for the responsible, experienced physician to weigh several sources of information in formulating a recommendation to the patient, even though definitive evidence-based data are not as yet available. Such sources may include assessment of the individual patient's clinical presentation, assessment of the severity of ischemia, and the patient's precise coronary anatomy. Critical for more-reliable decision making will be future development of accurate measures of the individual patient's risk of MI and/or death, whether by biomarker, imaging, or ischemia assessments., (Copyright © 2013 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: To determine whether staged percutaneous coronary intervention (PCI) within the same hospitalization as primary PCI is safe., Background: In ST-segment elevation myocardial infarction (STEMI) patients with multivessel disease undergoing primary PCI, staged non-culprit vessel PCI at a separate session is recommended., Methods: We conducted a retrospective analysis of 282 consecutive STEMI patients with multivessel disease who underwent primary PCI followed by staged PCI of the non-culprit vessel. Patients were categorized into staged PCI in the same hospitalization (n=184) and staged PCI at a separate hospitalization within 8 weeks of primary PCI (n=98)., Results: Baseline characteristics, presentation of STEMI, and procedural characteristics were similar in both groups. Contrast amount was higher in the separate hospitalization group for both index (175 vs. 153 ml, p=0.011) and staged (144 vs. 120 ml, p=0.004) procedures. More staged left main PCI was performed in the separate hospitalization group (3.9 vs. 0.3%, p=0.008). Angiographic success of staged PCI was similar in both groups, with similar rates of vascular complications and major bleeding. Following staged PCI, in-hospital major adverse cardiac events (3.3 vs. 1.0%, p=0.43) and mortality (2.7 vs. 0%, p=0.17) were similar in both groups., Conclusions: Our study supports the safety and feasibility of staged PCI within the same hospitalization as primary PCI, achieving similar procedural success and in-hospital outcomes as staged PCI at a separate hospitalization. Higher contrast amount used during primary PCI and presence of left main lesion in non-culprit vessels may influence the decision to stage the PCI at a separate hospitalization., (Copyright © 2013. Published by Elsevier Inc.)

Second-generation everolimus-eluting stents (EESs) have demonstrated superiority in efficacy and safety compared with first-generation drug-eluting stents (DESs) in the treatment of native coronary artery lesions. The present study evaluated and compared the safety and efficacy of EESs and first-generation DESs in saphenous vein graft lesions. The EES group consisted of 88 patients with 96 lesions, and the first-generation DES group consisted of 243 patients with 317 lesions (sirolimus-eluting stents, n = 212; paclitaxel-eluting stents, n = 105). The end points included target lesion revascularization, target vessel revascularization, major adverse cardiovascular events (composite of all-cause death, myocardial infarction, and target vessel revascularization), and definite stent thrombosis at 2 years. The groups had similar baseline characteristics and graft ages (128.1 ± 77.5 vs 132.4 ± 90.8 months, p = 0.686). The EES group had more type C lesions and less embolic protection device use. The peak postprocedure values of creatinine kinase-MB and troponin I were similar between the 2 groups. Overall, major adverse cardiovascular events occurred in 18.2% of EES patients and 35.0% of first-generation DES patients (p = 0.003), mainly driven by a lower target vessel revascularization rate (6.8% vs 24.5%, p <0.001). The target lesion revascularization rate was lower in the EES group (1.1% vs 11.6%, p = 0.005). Stent thrombosis was low and similar between the 2 groups (0% vs 0.8%, p = 1.000). On multivariate analysis, the type of DES implanted and graft age were the only independent predictors of major adverse cardiovascular events. In conclusion, the superiority of EESs compared with first-generation DESs shown in native artery lesions has been extended to saphenous vein graft lesions and should be considered as the DES of choice for this lesion type., (Copyright © 2013 Elsevier Inc. All rights reserved.)

Objectives: This study aimed to compare percutaneous coronary intervention (PCI) with direct stenting (DS) to balloon predilatation (PD) for patients undergoing elective PCI to determine whether there is an independent value for DS with regard to clinical outcomes., Background: The safety of PCI with DS has been established, but the independent advantages of this technique are not entirely clear., Methods: Patients undergoing elective PCI from January 2000 to December 2010 were included. The postprocedural and late clinical outcomes of 444 patients who underwent PCI with DS were compared with a propensity-matched population of 444 subjects treated with PD., Results: The two groups were well matched to 27 baseline clinical, procedural, and angiographic characteristics, thus allowing for a more accurate evaluation of the independent value of the stenting technique. Intravascular ultrasound was used in more than 60% of interventions in both groups. PCI performed with PD were longer (DS 45 ± 19.28 vs. PD 56 ± 23.72 minutes, P = 0.001), used more contrast (DS 154 ± 65.88 vs. PD 186 ± 92.84 cc, P = 0.001), and more frequently used balloon postdilation (DS 0% vs. PD 27.3%, P = 0.001). The incidence of periprocedural myocardial infarction (PPMI) was similar between DS- and PD patients (5.3% vs. 5.4%, P = 0.91). Likewise, the 1-year rates of major adverse cardiac events (8.4% vs. 6.3%, P = 0.25), target lesion revascularization (3.9% vs. 2.5%, P = 0.24), and definite stent thrombosis (0.2% vs. 0.9%, P = 0.37) were similar among DS and PD patients, respectively., Conclusion: During elective PCI, DS decreases overall procedure time and resource utilization, but fails to reveal an independent clinical advantage as there is no demonstrable benefit in regard to the incidence of PPMI, restenosis, or overall clinical outcomes up to 1-year of follow-up., (Copyright © 2013 Wiley Periodicals, Inc.)

Although second-generation everolimus-eluting stents (EESs) have demonstrated superiority over first-generation paclitaxel-eluting stents for a broad subset of patients and lesions, it is unclear whether the same applies to sirolimus-eluting stents (SESs). The present study compared the long-term clinical outcomes between EESs and SESs in patients with small coronary artery disease. A cohort of 643 patients treated with EESs (220 patients with 245 lesions) or SESs (423 patients with 523 lesions) in small vessel lesions (defined as those receiving stents ≤2.5 mm) were retrospectively analyzed. The end points included target lesion revascularization, target vessel revascularization, major adverse cardiovascular events (all-cause death, myocardial infarction, or target lesion revascularization), and definite stent thrombosis at 1 year of follow-up. The baseline characteristics were generally similar between the 2 groups, except that more systemic hypertension was seen in the EES group and more patients had a family history of coronary artery disease in the SES group. The 1-year target lesion revascularization (5.6% vs 4.8%, p = 0.68) and target vessel revascularization (5.6% vs 7.6%, p = 0.33) rates showed no significant differences between the EES and SES groups. Overall major adverse cardiovascular events occurred in 9.1% of the EES- and 8.6% of SES-treated patients (p = 0.83). This similar major adverse cardiovascular events rate remained after adjustment. The rate of stent thrombosis was 0% in the EES group and 1.2% in the SES group (p = 0.17). In conclusion, EESs demonstrated comparable clinical outcomes to those of SESs in small vessel interventions. The absence of stent thrombosis among patients treated with EESs suggests a good safety profile for this second-generation drug-eluting stent, which should be carefully studied in a larger series of patients with small vessel disease., (Copyright © 2013 Elsevier Inc. All rights reserved.)

Patients with acute coronary syndrome undergoing percutaneous coronary intervention (PCI) commonly receive a loading dose of either clopidogrel or prasugrel, in addition to aspirin. The present study aimed to assess the safety of reloading prasugrel in patients who had initially received a loading dose of clopidogrel compared to prasugrel loading alone. The study included a cohort of 606 consecutive patients with acute coronary syndrome who had received a 60-mg loading dose of prasugrel before PCI. These patients were then categorized into clopidogrel preloading (300 or 600 mg) followed by prasugrel reloading (CP-load group, n = 90) and prasugrel loading only (P-load group, n = 516). Both groups received a 10-mg maintenance dose of prasugrel after PCI. The primary end point was in-hospital Thrombolysis In Myocardial Infarction-defined major bleeding. The secondary end points were other in-hospital bleeding complications and major cardiovascular events. Patients in the CP-load group compared to the P-load group were younger, with lower rates of cardiovascular risk factors. Significantly more patients in the CP-load group presented with biomarker-positive myocardial infarction (80.0% vs 30.6%, p ≤0.001) and cardiogenic shock (5.6% vs 1.4%, p = 0.022). No significant differences (p = NS) were seen in Thrombolysis In Myocardial Infarction major bleeding (2.6% vs 2.8%), Thrombolysis In Myocardial Infarction major or minor bleeding (12.2% vs 7.0%), the need for blood transfusion (2.6% vs 2.1%), and vascular complications (1.3% vs 2.0%) between groups. The CP-load group experienced more in-hospital major adverse cardiac events (5.6% vs 1.6%, p = 0.031), urgent coronary artery bypass grafting (3.3% vs 0.2%, p = 0.011), and longer hospital and intensive care unit stays. In conclusion, preloading with clopidogrel should not be prohibitive to reloading with prasugrel in patients presenting with acute coronary syndrome and undergoing PCI with respect to bleeding and vascular complications., (Copyright © 2013 Elsevier Inc. All rights reserved.)

Aims: We hypothesized that patients with a history of either alarming or nuisance bleeding events, compared to those with no history of bleeding, would have lower levels of on-treatment platelet reactivity (aspirin and a thienopyridine)., Methods and Results: In total, 42 patients with no bleeding, 34 with nuisance bleeding, and 14 with alarming bleeding underwent platelet reactivity testing 1 month to 1 year after PCI with light transmission aggregometry (LTA 5 and 20 μM adenosine disphosphate [ADP]), vasodilator stimulated phosphoprotein phosphorylation (VASP) and VerifyNow P2Y12. Clinical and demographic characteristics of the 3 groups were generally similar, except that patients with alarming bleeding were less likely to be Caucasian; only 6 patients (6.7%) were taking prasugrel. There was considerable overlap between no bleeding, nuisance bleeding and alarming bleeding groups with respect to on-treatment platelet reactivity. Furthermore, there was no difference in the median platelet reactivity values for all assays. Prevalence of high on-treatment platelet reactivity did not differ among the 3 groups; 32.6% of patients had high on-treatment platelet reactivity as measured by LTA with 5 μM ADP (P=.91); 40.0% as measured by VASP (P=.35); and 35.6% as measured by VerifyNow P2Y12 (P=.61)., Conclusion: The use of platelet reactivity assays to identify patients on thienopyridine therapy at higher risk of bleeding is an unfounded strategy., (Copyright © 2013. Published by Elsevier Inc.)

The randomized TRial to Assess Improvement in Therapeutic Outcomes by Optimizing Platelet InhibitioN with Prasugrel-Thrombolysis In Myocardial Infarction (TRITON-TIMI) 38 trial compared prasugrel and clopidogrel in patients with acute coronary syndrome undergoing percutaneous coronary intervention (PCI). Patients treated with prasugrel had fewer ischemic events but more procedure-related bleeding. In the present study, we aimed to determine the effect of bivalirudin on bleeding in patients treated with prasugrel. A total of 692 patients with consecutive acute coronary syndrome underwent PCI with stent implantation and were anticoagulated with bivalirudin. The patients were divided into 2 groups according to the antiplatelet regimen (clopidogrel or prasugrel) chosen during or just after PCI. The bleeding complications during hospitalization were tabulated. Ischemic events were analyzed during hospitalization and at 30 days. Prasugrel was used in 96 patients (13.9%) and clopidogrel in 596 (86.1%). The clinical and procedural characteristics were similar, although the clopidogrel patients more often reported systemic hypertension (p = 0.01), previous PCI (p <0.001), and chronic renal insufficiency (p = 0.05). During hospitalization, the bleeding and ischemic complication rates were similar and low in both groups (major in-hospital complications 4.2% for clopidogrel vs 2.1% for prasugrel, p = 0.6; Thrombolysis In Myocardial Infarction major bleeding 2.5% vs 2.1%, p = 1.00; Thrombolysis In Myocardial Infarction minor bleeding 4.2% vs 5.2%, p = 0.6). At 30 days, no differences were found in ischemic events between both groups (target vessel revascularization/major adverse cardiac events 5.4% vs 2.1%, p = 0.2). In conclusion, prasugrel, when given after bivalirudin as the intraprocedural antithrombin agent for patients with acute coronary syndrome undergoing PCI, is as safe and effective as clopidogrel., (Copyright © 2013 Elsevier Inc. All rights reserved.)

Decreased success at work and educational attainment by adulthood are of concern for children with ADHD given their widely documented academic difficulties; however there are few studies that have examined this empirically and even fewer that have studied predictors and individual variability of these outcomes. The current study compares young adults with and without a childhood diagnosis of ADHD on educational and occupational outcomes and the predictors of these outcomes. Participants were from the Pittsburgh ADHD Longitudinal Study (PALS), a prospective study with yearly data collection. Significant group differences were found for nearly all variables such that educational and occupational attainment was lower for adults with compared to adults without histories of childhood ADHD. Despite the mean difference, educational functioning was wide-ranging. High school academic achievement significantly predicted enrollment in post-high school education and academic and disciplinary problems mediated the relationship between childhood ADHD and post-high school education. Interestingly, ADHD diagnosis and disciplinary problems negatively predicted occupational status while enrollment in post-high school education was a positive predictor. Job loss was positively predicted by a higher rate of academic problems and diagnosis of ADHD. This study supports the need for interventions that target the child and adolescent predictors of later educational and occupational outcomes in addition to continuing treatment of ADHD in young adulthood targeting developmentally appropriate milestones, such as completing post-high school education and gaining and maintaining stable employment.

Percutaneous coronary intervention of aorto-ostial lesions is associated with high rates of major adverse cardiovascular events. Precise implantation of coronary stents in the ostium is important in order to prevent adverse clinical outcomes. The presented case demonstrates a simple technique to accurately position a stent during aorto-ostial percutaneous coronary intervention., (Copyright © 2012 Elsevier Inc. All rights reserved.)

Background: Several patients undergoing permanent pacemaker (PPM) implantation/upgrade present with difficult access due to sub- or total central vein occlusion. Our institution has used the endovascular approach to recanalize central veins to allow for subsequent PPM implantation. Here we aim to describe the feasibility and safety of using this approach to allow for PPM implantation/upgrade., Methods: From October 2006 to November 2010, 50 consecutive patients who underwent central vein recanalization prior to PPM implantation were included in this analysis., Results: The population's mean age was 70 years, with a high rate of comorbidities including chronic renal failure (52.0%), congestive heart failure (64.0%), diabetes (33.3%) and peripheral vascular disease (36.0%). The endovascular recanalization procedure was performed via femoral access in all patients; however adjuvant brachial access was required in 13 cases and subclavian vein in one. Subclavian vein (74.5%) followed by innominate vein (21.6%) were the most common locations/target for recanalization. Successful vein recanalization followed by successful PPM implantation/upgrade was achieved in 48 patients (96.0%) without peri-procedural complications. Two patients died during the hospitalization, one due to severe respiratory failure and a second due to complicated end-stage renal disease, although neither was related to the endovascular procedure. No other event, including myocardial infarction, cerebral-vascular accident, bleeding/transfusion, or renal failure was identified., Conclusions: This study proved the feasibility and safety of the endovascular approach to recanalize central veins in patients with poor vascular access to allow for further PPM implantation/upgrade., (Copyright © 2012. Published by Elsevier Inc.)

Data from randomized clinical trials have shown the safety and efficacy of the XIENCE V in selected populations. However, limited data are available comparing the XIENCE V to the first-generation CYPHER sirolimus-eluting stent. This study aimed to assess the long-term safety and clinical efficacy of the XIENCE V everolimus-eluting stent compared to first-generation stents in an unselected patient population. This retrospective analysis included 6,069 patients treated with CYPHER, TAXUS, and XIENCE stents from 2003 to 2009 at our institution. The patients were followed up for ≥1 year after the index procedure. The baseline characteristics were generally comparable among the 3 groups, with the exception of a significantly greater prevalence of diabetes mellitus, systemic hypertension, and a history of angioplasty and coronary bypass surgery among the XIENCE patients. The XIENCE patients also had a twofold greater rate of type C lesions. One-year follow-up data were available for 82% of the patients. The 1-year major adverse cardiovascular events rate was 9.3% for the XIENCE stent versus 9.8% for the CYPHER stent and 11.5% for the TAXUS stent (p = 0.11). Mortality was lower in the XIENCE group than in the CYPHER and TAXUS groups (3.6% vs 4.9% vs 7.2%, respectively, p <0.001), and target lesion revascularization was similar (5.9% vs 5.2% vs 5.6%, respectively; p = 0.34). Stent thrombosis was lower in the XIENCE patients (0.2% vs 1.2% vs 0.7%, p = 0.007). In conclusion, in a contemporary United States clinical practice with an unselected patient population, use of the XIENCE V stent was associated with an improved safety profile and reduction of all-cause mortality and stent thrombosis compared to first-generation drug-eluting stents. The XIENCE V failed to demonstrate superiority for overall major adverse cardiovascular events, Q-wave myocardial infarction, and revascularization rates., (Copyright © 2012 Elsevier Inc. All rights reserved.)

Background: End-stage renal disease (ESRD) is known to correlate with poor outcome in patients undergoing percutaneous coronary intervention (PCI). This study examines the impact of diabetes mellitus (DM) on the long-term outcome of patients with ESRD on chronic hemodialysis., Methods: A cohort of patients with ESRD on chronic hemodialysis, who underwent PCI with drug-eluting stents, was followed for 1 year. The clinical outcome in this population was compared retrospectively based on the presence of DM. Major adverse cardiac events (MACE) as the composite of all-cause death, Q-wave myocardial infarction and target lesion revascularization (TLR), as well as TLR as an individual outcome, were the main end points of the study., Results: In the study cohort (n = 198), 48.5% had DM. Diabetic patients were more commonly female. The lesion characteristics were similar between groups except for more frequent saphenous vein graft intervention in nondiabetics. At 1-year follow-up there was no difference in the rate of MACE between diabetic and nondiabetic patients (40.4% vs. 39.3%, respectively, p = 0.89), driven primarily by a very high mortality rate (1-year overall mortality of 33.5%). After adjustment for the relevant clinical co-variables, DM was not associated with the composite end point. However, diabetic patients had a significantly higher incidence of 1-year TLR compared to nondiabetics (13.8% vs. 3.6%, respectively, p = 0.04)., Conclusion: The prognosis of patients with ESRD after PCI is dismal with a very high overall mortality rate regardless of the presence of DM. Patients with ESRD appear to be at higher risk for the need of revascularization., (©2011 Wiley Periodicals, Inc.)

Background: The optimal percutaneous treatment of drug-eluting stent (DES) in-stent restenosis (ISR) and the correlates for recurrent DES ISR remain unclear., Methods and Results: From 2003 to 2008, 563 patients presenting with recurrent symptoms of ischemia and angiographic ISR after DES implantation were included. Of these, 327 were treated with re-DES (58.1%), 132 underwent vascular brachytherapy (23.4%), and 104 were treated with conventional balloon angioplasty (18.5%). Variables associated with target lesion revascularization at 1 year were explored by individual proportional hazard models. This population presents a high prevalence of comorbidities, including diabetes (43.7%), previous myocardial infarction (MI) (45.8%), coronary bypass graft surgery (39.2%), chronic renal failure (18.8%), and heart failure (17.3%). Baseline clinical characteristics were balanced among the 3 groups; however, patients undergoing vascular brachytherapy presented with more complex lesions and a higher prevalence of prior stent/vascular brachytherapy failure than did the rest of the population. The overall incidence of recurrent DES failure at 1-year follow-up was 12.2%, which was similar among the 3 groups (P=0.41). The rate of the composite end point (death, Q-wave-MI and target lesion revascularization) at 1-year follow-up was 14.1% for re-DES, 17.5% for vascular brachytherapy, and 18.0% for conventional balloon angioplasty (P=0.57). After univariable analysis tested the traditional known covariates related to ISR, none of them were associated with repeat target lesion revascularization., Conclusions: Recurrence of ISR after DES treatment failure is neither infrequent nor benign, and optimal therapy remains unclear and challenging. Given the absence of traditional risk factors for ISR in this population, further research is required to elucidate both the correlates involved in DES ISR and the optimal treatment for this condition.

Ischemic cardiomyopathy with depressed left ventricular ejection fraction (LVEF) is predictive of death after percutaneous coronary intervention (PCI), but its association with stent thrombosis (ST) and the need for repeat revascularization is less clearly defined. In total 5,377 patients undergoing PCI were retrospectively evaluated. Multivariable Cox proportional hazards regression and competitive outcome analysis were employed. The primary end point was 1-year major adverse cardiac events (all-cause death, Q-wave myocardial infarction, ST, and target lesion revascularization [TLR]). Individual end points of ST and of TLR were also evaluated. Patients with normal LVEF (>50%) were compared to those with mild (41% to 50%), moderate (25% to 40%), and severe (<25%) decreases in LVEF. Patients with abnormal LVEF were older and more commonly diabetic and had renal insufficiency and heart failure syndrome (p <0.001 for all variables). These patients demonstrated more angiographically complex lesions and less frequently received a drug-eluting stent. The primary end point was significantly increased in patients with lower LVEF (9.7% for normal LVEF vs 20.6% for severely decreased LVEF, p <0.001). ST occurred more frequently in these patients (1.4% for normal LVEF vs 6% for severely decreased LVEF, p <0.001), but clinically driven TLR did not significantly change across LVEF categories. After adjustment, only moderate and severe LVEF decreases (i.e., LVEF ≤40%) demonstrated an association with major adverse cardiac events and with the individual outcome of ST. Subgroup analysis of patients receiving only a drug-eluting stent or a bare-metal stent demonstrated no statistically significant differences for the probability of ST. In conclusion, decreased LVEF is not associated with clinically driven TLR but does increase the risk of ST. Patients with LVEF ≤40% appear to be at significantly higher risk for ST and therefore might benefit from interventional and pharmacologic strategies aimed at minimizing this risk., (Copyright © 2012 Elsevier Inc. All rights reserved.)

Vascular complications (VCs) occur in 3% to 8% of percutaneous coronary interventions (PCIs). However, only a portion of patients who experience VCs bleed significantly. The aim of this study was to assess the covariates associated with the amount of blood loss in patients experiencing postprocedural VCs as well as the effect of the degree of blood loss on long-term mortality. Overall, 7,718 unselected patients who underwent PCI through femoral access were evaluated. Those experiencing VCs were identified and stratified with regard to the degree of hematocrit (HCT) decrease after the procedure. In total, 444 patients (5.8%) had VCs. Compared to those without VCs, patients with VCs were older and had more extensive co-morbidities. Severe blood loss was most frequent in those who had vascular perforation requiring surgical repair or in those who had retroperitoneal bleeding. Overall, <25% of patients with hematoma had severe blood loss. The raw 1-year mortality was doubled in patients with minimal or moderate HCT decrease and was tripled in those with severe decreases in HCT. Similarly, the rate of definite stent thrombosis was tripled in patients with VCs and moderate or severe decreases in HCT. After adjustment, only patients with VCs and the greater HCT decreases had an increased risk for death at 1 year (hazard ratio 1.80, 95% confidence interval 1.03 to 3.14). Independent predictors of severe HCT decrease included age, female gender, glycoprotein IIb/IIIa inhibitor use, and activated clotting time peak. Bivalirudin and closure devices were independently associated with less frequent severe HCT decrease. In conclusion, VCs do not entail an increased risk for death at 1 year unless associated with severe blood loss. The use of bivalirudin and closure devices seems to reduce the risk for such complications., (Copyright © 2012 Elsevier Inc. All rights reserved.)

Background: Tattoos have played an important role in human culture for thousands of years, and they remain popular today. The development of quality-switched (QS) lasers has revolutionized the removal of unwanted tattoos., Objectives: To thoroughly review the literature on laser tattoo removal pertaining to its history, its theoretical basis, the various devices used, potential adverse effects, and future developments., Material and Methods: An extensive literature review of publications related to tattoo removal was conducted., Results: Reports exist demonstrating the efficacy of laser removal of different tattoo types, including professional, amateur, traumatic, cosmetic, and medical. The literature supports the use of different QS lasers for removal of tattoos. Some colors have a more-complete response using particular wavelengths., Conclusion: QS lasers can effectively and safely remove different types of unwanted tattoos., (© 2011 by the American Society for Dermatologic Surgery, Inc. Published by Wiley Periodicals, Inc.)

The coexistence of mitral regurgitation (MR) in patients with severe aortic stenosis (AS) is not infrequent and has been associated with adverse outcome. The aims of this study were to evaluate the change in MR severity and to identify the correlates of MR improvement in patients with severe AS and moderate to severe MR who underwent balloon aortic valvuloplasty (BAV). Patients with severe AS and at least moderate MR who underwent their first BAV procedures (n = 74) were divided into 2 groups: patients with improved- (n = 34 [46%]) and those without improved (n = 40 [54%]) MR after BAV on transthoracic echocardiography. The population had a mean age of 84 years and was more frequently female (63.5%), with a high risk profile (mean Society of Thoracic Surgeons score 15%, mean European System for Cardiac Operative Risk Evaluation score 57%). Baseline characteristics were balanced between the 2 groups. Patients with improved MR after BAV had smaller left atrial dimensions (45 ± 7 vs 49 ± 7 mm, p = 0.01) and lower peak aortic velocities (3.7 ± 0.6 vs 4.0 ± 0.8 m/s, p = 0.05) and mean transaortic valve gradients (33.2 ± 12.1 vs 40.6 ± 17.4 mm Hg, p = 0.05) at baseline. Left atrial dimension [odds ratio (OR) 3.37, p = 0.006], left ventricular end-diastolic dimension (OR 2.7, p = 0.04), and mean transaortic valve gradient (OR 1.04, p = 0.05), but not left ventricular systolic function or functional MR, were correlated with MR improvement by logistic regression analysis. In conclusion, nearly half of the patients with severe AS and coexistent MR showed improvement in the magnitude of MR after BAV. Larger left atrial and left ventricular end-diastolic dimensions and higher transaortic valve gradients were associated with lack of MR improvement., (Copyright © 2011 Elsevier Inc. All rights reserved.)

Background: High on-treatment platelet reactivity is an established risk factor for adverse cardiac events in patients taking clopidogrel following percutaneous coronary intervention (PCI)., Methods: Two hundred patients underwent platelet reactivity testing with VerifyNow P2Y12, vasodilator-stimulated phosphoprotein phosphorylation (VASP), and light transmission aggregometry (LTA) with both 5 and 20 μM of adenosine diphosphate (ADP) following PCI. High on-treatment platelet reactivity was defined as a maximum platelet aggregation ≥46% for LTA ADP 5 μM or ≥60% for 20 μM; platelet reactivity index (PRI) ≥50% for VASP; and platelet reactivity units ≥235 for VerifyNow. Correlation between assays was tested using Spearman coefficients (ρ); agreement among tests in regards to high on-treatment platelet reactivity was evaluated with Kappa statistics (κ)., Results: All Spearman correlations had P values <0.001, although ρ ranged from 0.60-0.86. The incidence of high on-treatment platelet reactivity was 39.3% with VASP, 27.3% with VerifyNow, 23.1% with LTA ADP 5 μM, and 16.2% with LTA ADP 20 μM. The strongest correlation was between LTA ADP 5 μM and LTA ADP 20 μM (κ= 0.53, 95% CI 0.37-0.68); the weakest was between VASP and LTA ADP 5 μM (κ= 0.33, 95% CI 0.19-0.47). Overall, the level of agreement between assays was in the moderate to poor range., Conclusion: Despite evidence that the most commonly used tests are correlated, agreement among tests is modest at best and demonstrates they are not interchangeable. , (©2011, Wiley Periodicals, Inc.)

Disturbances in atrioventricular conduction are well-recognized complications of transcatheter aortic valve replacement. Percutaneous balloon aortic valvuloplasty (BAV) is a requisite step in transcatheter aortic valve replacement; however, the contribution of the BAV to atrioventricular conduction disturbances has not been elucidated. The present analysis was undertaken to ascertain the incidence and type of electrocardiographic changes associated with BAV and to consider the role of BAV in the conduction abnormalities after transcatheter aortic valve replacement. In 271 consecutive patients with symptomatic, severe aortic stenosis undergoing BAV, a standard 12-lead electrocardiogram was obtained before and serially after the procedure. Each was examined by experienced electrocardiographers. The cohort was divided into 2 groups with regard to the post-BAV appearance of conduction disturbances. The clinical and procedural characteristics of patients with these disturbances were compared to those in whom no conduction disturbance appeared. After BAV, 23 patients (8.5%) met the study definition of "new conduction defect": 4 patients (1.5%) required permanent pacemaker implantation for advanced atrioventricular block. New left bundle branch block appeared in 9 (3.3%) and left anterior hemiblock in 7 (2.6%). New right bundle branch block appeared in 2 and left posterior hemiblock in 1. No significant difference was found in the clinical or procedural characteristics. The ratio of the balloon size to the left ventricular outflow tract diameter was 1.21 ± 1.6 in those with new conduction defects and 1.15 ± 0.12 (p = 0.032) in those without. In conclusion, BAV is associated with a low incidence of cardiac conduction disturbances and a requirement for permanent ventricular pacing. The size of the valvuloplasty balloon should be carefully selected to avoid oversizing, which can lead to the development of postprocedure conduction disturbances., (Copyright © 2011 Elsevier Inc. All rights reserved.)

Background: The primary inclusion criteria from both the Society of Thoracic Surgeons (STS) score and the logistic EuroSCORE are currently used to identify high-risk and inoperable patients eligible for transcatheter aortic valve implantation (TAVI). We aimed to examine the correlation between STS and logistic EuroSCOREs and their performance characteristics in patients referred for TAVI., Methods: The study cohort consisted of 718 high-risk patients with severe aortic stenosis who were considered for participation in a TAVI clinical trial. The performance of the STS and logistic EuroSCOREs was evaluated in three groups: (a) medical management or balloon aortic valvuloplasty (BAV), 474 (66%); (b) 133 patients (18.5%) with surgical aortic valve replacement (AVR); (c) 111 (15.4%) with TAVI. The mean age was 81.8 ± 8.1 years, and 394 (54.8%) were female., Results: The mean STS score was 11.5 ± 6.1, and the mean logistic EuroSCORE was 39.7 ± 23.0. Pearson correlation coefficient showed moderate correlation between the STS and logistic EuroSCOREs (r = 0.61, P < .001). At a median follow-up of 190 days (range, 67-476), 282 patients (39.2%) died. The STS and logistic EuroSCOREs were both higher in patients who died as compared to those in survivors (13.1 ± 6.2 vs.10.0 ± 5.8 and 43.4 ± 23.1 vs. 37.5 ± 22, respectively; P < .001). The observed and predicted 30-day mortality rates in the medical/BAV group were 10.1% observed, 12.3% by STS and 43.1% by logistic EuroSCORE. In the surgical AVR group, the rates were 12.8% observed, 8.4% by STS and 25.6% by logistic EuroSCORE. In the TAVI group, the rates were 11.7% observed, 11.8% by STS and 41.2% by logistic EuroSCORE. The odds ratio (OR) for 30-day mortality in the medical/BAV group was 1.05 (P = .01) with STS and 1.003 (P = .7) with logistic EuroSCORE. In the surgical AVR group, the OR was 1.09 (P = .07) with STS and 1.007 (P = .6) with logistic EuroSCORE. In the TAVI group, the OR was 1.14 (P = .03) with STS and 1.03 (P = .04) with logistic EuroSCORE., Conclusion: In high-risk patients with severe aortic stenosis, STS score is superior to the logistic EuroSCORE in predicting mortality. Clinical judgment should play a major role in the selection of patients with severe aortic stenosis for the different therapeutic options., (Copyright © 2011. Published by Elsevier Inc.)

Coronary perforation (CP) is a rare but catastrophic event that may be influenced by the procedural anticoagulation regimen. This study compared the consequences of CP in patients who underwent anticoagulation with bivalirudin (BIV; a nonreversible direct thrombin inhibitor with a shorter 1/2-life than heparin) to those in patients who underwent anticoagulation with heparin (HEP) at time of CP. Patients with CP were identified from 33,613 procedures available in our institutional angioplasty registry. The outcome of this group was compared based on anticoagulation regimen (BIV vs HEP). The primary end point for this analysis was the composite of in-hospital death, cardiac tamponade, or emergency cardiac surgery. Overall a cohort of 69 patients (0.2%) with CP was identified. BIV was the intraprocedural anticoagulant in 41 patients, whereas HEP was used in 28. Baseline characteristics were comparable between groups except for a higher frequency of systemic hypertension and hypercholesterolemia in the BIV group. Procedural characteristics were also similar including lesion complexity and perforation severity. Nearly 1/2 of CPs in each group was managed with prolonged balloon inflation alone. Protamine was used in 46% of HEP-treated patients. Covered stents tended to be used more frequently in the BIV group (p = 0.061). The primary composite end point was similar between groups (odds ratio 1.42, 95% confidence interval 0.47 to 4.29, p = 0.53). However, there was a lower rate of cardiac surgery requirement in BIV-treated patients (p = 0.037). In conclusion, our study suggests that choice of procedural anticoagulant agent does not influence outcome when CP occurs. Therefore, use of BIV should not be discouraged in patients undergoing high-risk intervention for perforations., (Copyright © 2011 Elsevier Inc. All rights reserved.)

Previous research has suggested that obesity is associated with increased high on-treatment platelet reactivity. We therefore tested platelet reactivity in 251 patients with VerifyNow P2Y12, vasodilator-stimulated phosphoprotein phosphorylation, and light transmission aggregometry with adenosine diphosphate 5 and 20 μM 6 to 24 hours after percutaneous coronary intervention. High on-treatment platelet reactivity was defined as a maximum platelet aggregation ≥46% for light transmission aggregometry with adenosine diphosphate 5 μM or ≥60% for 20 μM, platelet reactivity index ≥50% for vasodilator-stimulated phosphoprotein phosphorylation, and P2Y12 reaction units ≥235 for VerifyNow. The relation between body mass index (BMI) and platelet reactivity values was examined with Spearman coefficients; BMI and high on-treatment platelet reactivity were assessed with Student's t test. Multivariable logistic regression for high on-treatment platelet reactivity was also performed. Average BMI was 30.3 ± 5.9 kg/m² and 44% of patients had a BMI ≥30 kg/m². Overall there was very poor correlation between BMI and on-treatment platelet reactivity, with Spearman coefficients ranging from 0.08 to 0.10. BMI was also not associated with the various definitions of high on-treatment platelet reactivity. Multivariable logistic regressions showed no association between BMI and high on-treatment platelet reactivity. In conclusion, and contrary to previous reports, we found no association whatsoever between BMI and on-treatment platelet reactivity as quantified by a variety of platelet function tests., (Copyright © 2011 Elsevier Inc. All rights reserved.)

Background: The adjunctive use of eptifibatide in patients undergoing primary percutaneous coronary intervention (PCI) for ST-elevation myocardial infarction (STEMI) remains controversial. We therefore set out to determine the safety and efficacy of eptifibatide in this population., Methods: The study comprised 857 consecutive patients who underwent primary PCI for STEMI at the Washington Hospital Center. Three hundred eighteen patients also received adjunctive therapy with eptifibatide. Patients who had received thrombolysis prior to undergoing cardiac catheterization were excluded. The primary end-point was all-cause mortality and the composite of all-cause mortality or Q-wave MI. The primary safety end-point was the rate of thrombolysis in myocardial infarction (TIMI) major bleeding., Results: The eptifibatide group was younger, had a higher body mass index, and a lower proportion of patients with systemic hypertension, diabetes mellitus, previous history of ischemic heart disease, coronary revascularization, and congestive heart failure. This cohort also used bivalirudin less often (23.3% vs. 72%; P < 0.001). Following multivariable analysis, the eptifibatide group had a significantly lower rate of all-cause mortality (hazard ratio 0.55; 95% confidence interval 0.34-0.89; P = 0.01) and the composite of all-cause mortality or Q-wave MI (hazard ratio 0.59; 95% confidence interval 0.37-0.95; P = 0.03) at 6 months. The rate of TIMI major bleeding was similar in both groups (hazard ratio 0.54; 95% confidence interval 0.25-1.17; P = 0.12)., Conclusion: The adjunctive use of eptifibatide in patients presenting with STEMI may be associated with improved clinical outcomes. (J Interven Cardiol 2011;24:351-356)., (©2011, Wiley Periodicals, Inc.)

Objectives: We sought to describe characteristics of patients presenting with an acute MI from a SVG culprit, compared with a native culprit., Background: Percutaneous coronary intervention (PCI) of saphenous vein grafts (SVG) results in worse outcomes than native vessel PCI, but outcomes of such patients with acute myocardial infarction (MI) setting are not well-described., Methods: Patients presenting with ST-elevation or non-ST-elevation MI undergoing PCI from 2000 to 2010 were retrospectively analyzed to identify the culprit as a SVG vs. native vessel. Multiple linear regression was used to identify predictors of peak troponin-I level. Cox proportional hazards regression was used to identify predictors of 30-day mortality and 1-year major adverse cardiac events (MACE)., Results: 192 patients underwent PCI for a SVG culprit, compared with 4,001 with a native culprit. After multivariable adjustment, SVG culprit remained significantly associated with lower levels of the logarithm of the peak troponin (β = -0.17, SE = 0.07, P = 0.02). The likelihood of MACE was higher in SVG vs. native culprits in patients with small to modest troponin elevations. Patients with a SVG culprit also suffered higher unadjusted rates of mortality at 30 days (14.3% vs. 8.4%, P = 0.03) and MACE at 1 year (36.8% vs. 24.5%, P = 0.005); a modest effect upon mortality and MACE remained after multivariable adjustment., Conclusion: Even minimal elevations of troponin in patients with a SVG culprit may portend a poorer prognosis than in patients with a native culprit. The risk of PCI in this setting is driven by mortality and arises from both substantial comorbidities and the SVG itself., (Copyright © 2011 Wiley-Liss, Inc.)

Compared to paclitaxel-eluting stents (PESs) and sirolimus-eluting stents (SESs), a paucity of data exists regarding the clinical outcome of everolimus-eluting stents (EESs) in unselected patients with the entire spectrum of obstructive coronary artery disease. The present study cohort included 6,615 consecutive patients at Washington Hospital Center who underwent coronary artery stent implantation with EESs (n = 519), PESs (n = 2,036), or SESs (n = 4,060). Patients who received bare metal stents, zotarolimus-eluting stents, or 2 different drug-eluting stent types were excluded. The analyzed clinical end points were death, death or Q-wave myocardial infarction, target lesion revascularization (TLR), target vessel revascularization, definite stent thrombosis, and major adverse cardiac events, defined as the composite of death, Q-wave myocardial infarction, or TLR at 1 year. The groups were well matched for the conventional risk factors for coronary artery disease, except for systemic hypertension, which differed among the groups. The unadjusted end points for EESs and PESs were death (4.5% vs 7.1%; p = 0.03), TLR (3.4% vs 4.6%; p = 0.24), target vessel revascularization (5.6% vs 7.1%; p = 0.46), death or Q-wave myocardial infarction (4.5% vs 7.4%; p = 0.02), and definite stent thrombosis (0.0% vs 0.7%; p = 0.09). The unadjusted end points for EES and SES were death (4.5% vs 5.2%; p = 0.45), TLR (3.4% vs 5.8%; p = 0.3), target vessel revascularization (5.6% vs 8.6%; p = 0.05), death or Q-wave myocardial infarction (4.5% vs 5.4%; p = 0.39), and definite stent thrombosis (0.0% vs 1.08%; p = 0.003). The rates of major adverse cardiac events were similar among the 3 groups. After multivariate analysis, the rate of death or Q-wave myocardial infarction between the EES and PES groups was no longer significant (hazard ratio 1.14, 95% confidence interval 0.59 to 2.20, p = 0.70). In conclusion, the results of the present study suggest the use of EES in routine clinical practice is both safe and effective but offers no clinically relevant advantage in terms of hard end points compared to PES or SES., (Copyright © 2011 Elsevier Inc. All rights reserved.)

Objectives: Previous studies have found an apparent paradox in smokers: acute phase outcomes after an acute myocardial infarction are superior to those of nonsmokers. Furthermore, it is reported that smoking has an impact on the metabolism of clopidogrel. This study aimed to examine whether this paradoxical finding exists in patients who undergo drug-eluting stent implantation and are treated with clopidogrel., Methods: From April 2003 to June 2010, 1424 consecutive patients with acute myocardial infarction who underwent primary or rescue percutaneous coronary intervention with drug-eluting stent and clopidogrel were enrolled. They were divided into three groups: current smokers (n = 486); previous smokers (n = 349); and nonsmokers (n = 589). The primary end point was a composite of 30-day, all-cause death, nonfatal myocardial infarction, or definite stent thrombosis., Results: Compared with nonsmokers, current smokers were younger (P < 0.001) and more often men (P < 0.001). They had larger myocardial infarctions than did nonsmokers [maximum troponin I, 8.9 (2.4, 38.4) vs. 6.8 (1.4, 30.1) ng/ml, P = 0.01]. Current smokers less frequently met the primary end point than did nonsmokers (2.9 vs. 6.1%, P = 0.01). However, after adjustment for baseline and angiographic characteristics, the beneficial effect of smoking was no longer seen (odds ratio 1.35, confidence interval: 0.53-3.44, P = 0.5)., Conclusion: A beneficial effect of smoking ('smoker's paradox') in the unadjusted primary end point continues to be present; however, after adjustment for differences in baseline characteristics, no benefit was detectable.

Aims: The relationship between stent design and periprocedural myocardial infarction is unclear. The newest type of drug-eluting stent (DES), the everolimus-eluting stent (EES), has thinner strut and polymer thickness and a small amount of drug. EES use, therefore, could be related to less myocardial necrosis post-percutaneous coronary intervention (PCI). This study was undertaken to compare the amount of myocardial necrosis associated with implantation of the four DES types currently approved in the U.S., Methods and Results: A cohort of 7,259 consecutive patients who underwent elective PCI with DES implantation from 2003 to 2010 was studied. Sirolimus-eluting stents were deployed in 4420, paclitaxel-eluting stents in 1858, zotarolimus-eluting stents in 308, and EES in 673. The maximum creatine phosphokinase-MB (CPK-MB) was measured post-procedure and served as the primary endpoint. Patients who received EES had the smallest CPK-MB rise (p<0.0001) among the four groups. Further, a post-PCI increase was less often large enough to meet any of the usual criteria for periprocedural myocardial infarction used in clinical studies. After adjustment for baseline and angiographic characteristics, paclitaxel-, sirolimus-, and zotarolimus-eluting stent groups more frequently exceeded the CPK-MB >5x normal limit compared with EES-treated patients (OR=2.44, p=0.01; OR=2.01, p=0.05; OR=1.80, p=0.2, respectively)., Conclusions: It is plausible that EES with their superior design are associated with less periprocedural myocardial injury compared with older-generation DES.

The incidence, correlates, and prognostic implications of pulmonary hypertension (PH) are unclear in patients with severe aortic stenosis (AS). We studied 509 patients with severe AS evaluated for transcatheter aortic valve implantation (TAVI). Patients were divided into groups based on pulmonary artery systolic pressure (PASP): group I, 161 (31.6%) with PASP <40 mm Hg; group II, 175 (34.3%) with PASP 40 to 59 mm Hg; and group III, 173 (33.9%) with PASP ≥ 60 mm Hg. Group III patients were more symptomatic and had higher creatinine levels and higher left ventricular end-diastolic pressure. Transpulmonary gradient was >12 mm Hg in 17 patients (10.5%), 31 patients (17.7%), and 80 patients (46.2%) in groups I through III, respectively. In a median follow-up of 202 days (73 to 446) mortality rates were 35 (21.7%), 69 (39.3%), and 85 (49.1%) in groups I through III, respectively (p <0.001). Immediately after TAVI, in patients with PASP >40 mm Hg there was significant decrease in PASP (63.1 ± 16.2 to 48.8 ± 12.4 mm Hg, p <0.0001), which remained at 1 year (50.1 ± 13.1 mm Hg, p = 0.04). After surgical aortic valve replacement there was a significant immediate decrease in PASP (66.1 ± 16.3 to 44.7 ± 14.2 mm Hg, p <0.0001), which persisted at 3 to 12 months (44.8 ± 20.1 mm Hg, p <0.001). In patients who underwent balloon aortic valvuloplasty, PASP decreased immediately after the procedure (63.2 ± 14.8 to 51.8 ± 17.1 mm Hg, p <0.0001), yet at 3 to 12 months pressure returned to baseline levels (57.4 ± 17.0 mm Hg, p = 0.29). In conclusion, patients with severe AS have a high prevalence of PH, and in patients with severe AS increased PASP is associated with increased mortality. Surgical aortic valve replacement and TAVI are effective treatments for these patients and result in a significant PASP decrease., (Copyright © 2011 Elsevier Inc. All rights reserved.)

Aims: This study aimed to examine the strategy of hybrid percutaneous coronary intervention (PCI) -bare metal stent (BMS) and drug-eluting stent (DES)- versus exclusive DES implantation for patients undergoing multivessel PCI., Methods and Results: A cohort of 2,065 patients who underwent PCI (698 hybrid, 1,367 exclusive DES) were followed clinically up to one year. The primary outcome was target vessel revascularisation-major adverse cardiac events (TVR-MACE). Patients presenting with cardiogenic shock, anaemia (haematocrit <25), and bypass graft PCI were excluded. Only patients with ≥ 2 stents in two different lesions were analysed for this study. Baseline and procedural characteristics were similar. Major in-hospital complications and subacute stent thrombosis rates were similar. At one year, there was no difference in TVR-MACE (hybrid 17.2% vs. DES 14.6%, p=0.128). On multivariable analysis, hybrid PCI was not a predictor of TVR-MACE. The strongest predictors of TVR-MACE at one year were hypertension and African American race. Cumulative stent thrombosis rates at one year were similar in both groups., Conclusions: Patients who undergo hybrid PCI have similar composite in-hospital and 1-year outcomes as those who undergo exclusive DES PCI. The hybrid stent approach should be considered for patients with multivessel PCI since it can lower the procedure cost without increasing adverse events.

This study compared the high school academic experience of adolescents with and without childhood ADHD using data from the Pittsburgh ADHD Longitudinal Study (PALS). Participants were 326 males with childhood ADHD and 213 demographically similar males without ADHD who were recruited at the start of the follow-up study. Data were collected yearly from parents, teachers and schools. The current study used assessment points at which the participants were currently in or had recently completed grades 9, 10, 11, and 12. Results indicated that adolescents with ADHD experienced significant academic impairment in high school relative to comparison adolescents, including lower overall and main academic subject grade point averages (GPA), lower levels of class placement (e.g. remedial vs. honors), and higher rates of course failure. In addition, teacher reports indicated that adolescents with ADHD completed and turned in a significantly lower percentage of assignments and were significantly less likely to be working up to their potential. Adolescents with ADHD were also significantly more likely to be absent or tardy during the academic year, and they were over eight times more likely than adolescents without ADHD to drop out of high school. These findings demonstrate that children with ADHD continue to experience severe academic impairment into high school.

Previous studies have documented disparities in both access to invasive cardiovascular procedures and outcomes in patients with Medicaid, Medicare, or no insurance. Outcomes by insurance have yet not been examined in a percutaneous coronary intervention (PCI) population. Data from patients undergoing PCI from June 2000 to June 2009 were retrospectively analyzed. Insurance was categorized as private, Medicare, Medicaid, and uninsured, according to the primary insurance at discharge. The outcome variable of interest was major adverse cardiac events (a composite of death, Q-wave myocardial infarction, and target vessel revascularization) at 1 year. Multivariable Cox regression analysis was stratified according to age <65 and ≥65 years. Of the 13,573 patients who had undergone PCI, 6,653 (49.0%) had private insurance, 6,150 (45.3%) had Medicare, 486 (3.6%) had Medicaid, and 284 (2.1%) were uninsured. Of the patients <65 years old, Medicaid (hazard ratio [HR] 1.59, 95% confidence interval [CI] 1.04 to 2.43), Medicare (HR 2.18, 95% CI 1.58 to 2.99), and no insurance (HR 2.41, 95% CI 1.36 to 4.27) were associated with greater rates of adjusted major adverse cardiac events at 1 year compared with private insurance. Of the patients ≥65 years old, only Medicaid (HR 3.07, 95% CI 1.09 to 8.61) was associated with a greater rate of adjusted major adverse cardiac events at 1 year. In conclusion, patients with government-sponsored insurance and no insurance have worse cardiovascular outcomes than patients with private insurance after PCI at 1 year. This implies that the provision of health insurance alone might not have a dramatic effect on cardiovascular outcomes after PCI., (Copyright © 2011 Elsevier Inc. All rights reserved.)

Background: Original descriptions of the takotsubo syndrome (TS) included a characteristic left ventricular (LV) contraction pattern, "apical ballooning." Recently, several reports have associated contraction patterns not strictly conforming to the original description with TS. The specifics of the contraction pattern seem to set TS apart from the much larger population of patients with acute coronary syndrome (ACS) but no obstructive coronary artery disease (OCAD). This study was undertaken to compare patients with midventricular and apical dysfunction with those with other LV contraction patterns., Hypothesis: If TS can present with a variety of patterns of LV dysfunction, then both those with and those without the pattern should have the clinical components previously assigned to the syndrome., Methods: We studied LV contraction patterns in consecutive ACS patients referred for consideration of emergent or urgent percutaneous coronary intervention., Results: Of the 893 patients evaluated in 2008, we excluded 862 on the basis of OCAD, preexisting LV dysfunction, or an obvious alternative cause of symptoms. The remaining 31 (3.5%) also had no OCAD but manifested an LV contraction abnormality. We compared the 15 patients (1.7%) whose ventriculograms met criteria for TS with the 16 patients (1.8%) whose did not. The most common alternative pattern was global hypokinesis, followed by a variety of segmental contraction abnormalities. Patients with the TS pattern were older and had evidence of greater myocardial injury. More than 85% were women., Conclusions: The TS pattern identifies a distinct subset of ACS patients with a remarkable predominance of postmenopausal women and is therefore fundamental to the definition of this entity. This distinctive facet of the syndrome is likely to be an important clue to its pathogenesis. We did not encounter patients with other patterns of LV dysfunction that could be thought to represent stress-induced cardiomyopathy. Copyright © 2011 Wiley Periodicals, Inc. The authors have no funding, financial relationships, or conflicts of interest to disclose., (© 2011 Wiley Periodicals, Inc.)

Objectives: We sought to replicate the association between the kinesin-like protein 6 (KIF6) Trp719Arg polymorphism (rs20455), and clinical coronary artery disease (CAD)., Background: Recent prospective studies suggest that carriers of the 719Arg allele in KIF6 are at increased risk of clinical CAD compared with noncarriers., Methods: The KIF6 Trp719Arg polymorphism (rs20455) was genotyped in 19 case-control studies of nonfatal CAD either as part of a genome-wide association study or in a formal attempt to replicate the initial positive reports., Results: A total of 17,000 cases and 39,369 controls of European descent as well as a modest number of South Asians, African Americans, Hispanics, East Asians, and admixed cases and controls were successfully genotyped. None of the 19 studies demonstrated an increased risk of CAD in carriers of the 719Arg allele compared with noncarriers. Regression analyses and fixed-effects meta-analyses ruled out with high degree of confidence an increase of ≥2% in the risk of CAD among European 719Arg carriers. We also observed no increase in the risk of CAD among 719Arg carriers in the subset of Europeans with early-onset disease (younger than 50 years of age for men and younger than 60 years of age for women) compared with similarly aged controls as well as all non-European subgroups., Conclusions: The KIF6 Trp719Arg polymorphism was not associated with the risk of clinical CAD in this large replication study., (Copyright © 2010 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: This study aimed to determine the success, complications, and survival of patients after balloon aortic valvuloplasty (BAV)., Background: The introduction of transcatheter aortic valve implantation (TAVI) BAV has led to a revival in the treatment of patients with severe aortic stenosis., Methods: A cohort of 262 patients with severe aortic stenosis underwent 301 BAV procedures. Of these, 39 (14.8%) patients had ≥2 BAV procedures. Clinical, hemodynamic, and follow-up mortality data were collected., Results: The cohort mean age was 81.7 ± 9.8 years, and the mean Society of Thoracic Surgeons and logistic EuroSCORE (European System for Cardiac Operative Risk Evaluation) was 13.3 ± 6.7 and 45.6 ± 21.6, respectively. BAV was performed as a bridge to TAVI or to surgical aortic valve replacement in 28 patients (10.6%) and for symptom relief in 234 (89.4%). The mean aortic valve area (AVA) increased from 0.58 ± 0.3 cm(2) to 0.96 ± 0.3 cm(2) (p < 0.001). Of these, 111 (45.0%) had final AVA >1 cm(2), and in 195 patients (79%), AVA increased by >40%. De novo BAV resulted in a higher mean increase in AVA 0.41 ± 0.24 cm(2) versus 0.28 ± 0.24 cm(2) in redo BAV (p = 0.003). Serious adverse events occurred in 47 patients (15.6%), intraprocedural death in 5 (1.6%), stroke in 6 (1.99%), coronary occlusion in 2 (0.66%), severe aortic regurgitation in 4 (1.3%), resuscitation/cardioversion in 5 (1.6%), tamponade in 1 (0.33%), and permanent pacemaker in 3 (0.99%). A vascular complication occurred in 21 patients (6.9%); 34 (11.3%) had a post-procedure rise in creatinine >50%; and 3 (0.99%) required hemodialysis. During median follow-up of 181 days, the mortality rate was 50% (n = 131). The mortality rate in the group with final AVA >1 cm(2) was significantly lower than in the group with final AVA of <1 cm(2) (36.4% vs. 57.9%, p < 0.001). Final AVA was associated with lower mortality (hazard ratio: 0.46, p = 0.03). BAV as a bridge to TAVI or surgical aortic valve replacement had a better outcome compared with BAV alone: mortality rate 7 (25%) versus 124 (52.9%), respectively (p < 0.0001)., Conclusions: Long-term survival is poor after BAV alone. BAV as a bridge to percutaneous or surgical aortic valve replacement is feasible, safe, and associated with better outcome than BAV alone., (Copyright © 2010 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Gastrointestinal bleeding (GIB) complicating percutaneous coronary intervention (PCI) results in high mortality, but clinical factors associated with and long-term outcomes of GIB are poorly understood. We sought to examine clinical and procedural factors associated with GIB complicating PCI. We also examined the impact of GIB on 30-day mortality and 1-year major adverse cardiac events (MACEs). Patients undergoing PCI from January 2000 to January 2010 were retrospectively analyzed for the occurrence of in-hospital GIB. Multivariable logistic regression and Cox proportional hazards regression were used to identify predictors of in-hospital GIB and 30-day mortality. Landmark analysis of patients surviving to hospital discharge was performed to assess the impact of GIB on 1-year MACEs. Of 20,621 patients who underwent PCI, 147 (0.72%) who developed in-hospital GIB were identified. Variables associated with increased risk of GIB included older age, shock, acute myocardial infarction, chronic renal insufficiency, lower baseline hematocrit, and glycoprotein IIb/IIIa inhibitors; bivalirudin decreased the risk. Unadjusted 30-day mortality rate of patients with GIB was 20.5% compared to 2.4% of patients without GIB. After multivariable adjustment, GIB and shock (and an interaction between the 2) were the most important correlates of 30-day mortality. In the population surviving to discharge, however, GIB was not associated with adjusted mortality or MACEs. In conclusion, GIB complicating PCI has a dramatic impact on 30-day mortality, and bivalirudin was associated with lower rates of GIB., (Copyright © 2010 Elsevier Inc. All rights reserved.)

Background: It has been suggested that black race predicts stent thrombosis (ST) after drug-eluting stent implantation. Whether socioeconomic status or comorbid conditions confound the contribution of black race to the development of ST is unclear., Methods and Results: We compared 1594 black patients who underwent drug-eluting stent implantation with 5642 nonblack patients. Overall, 108 definite STs were reported. Multivariable Cox regression analysis was performed with adjustment for comorbidities, including median household income as a marker of socioeconomic status, to assess the impact that black race may have on the development of ST. On univariable analysis, black patients were younger (63.43±12.42 versus 65.15±12.59 years; P<0.001) and more likely to have a history of hypertension (89.8% versus 81.7%; P<0.001), diabetes mellitus (45.5% versus 30.8%; P<0.001), chronic renal insufficiency (19.2% versus 10.7%; P<0.001), and congestive heart failure (18.7% versus 13.1%; P<0.001). Clopidogrel compliance at the time of the ST event was higher in the black than in the nonblack population (87.5% versus 77.8%; P=0.068). After multivariable analysis, including adjustment for median income and clopidogrel compliance, black race emerged as a strong predictor of definite late ST., Conclusions: Black race is an independent predictor of definite drug-eluting stent ST. Because clopidogrel compliance was higher in black patients and socioeconomic status was not associated with ST, further investigation into the potential mechanisms of this influence of race on ST must be pursued.

Background: Transcatheter aortic valve implantation is currently being evaluated in patients with severe aortic stenosis who are considered high-risk surgical candidates. This study aimed to detect incidences, causes, and correlates of mortality in patients ineligible to participate in transcatheter aortic valve implantation studies., Methods and Results: From April 2007 to July 2009, a cohort of 362 patients with severe aortic stenosis were screened and did not meet the inclusion/exclusion criteria necessary to participate in a transcatheter aortic valve implantation trial. These patients were classified into 2 groups: group 1 (medical): 274 (75.7%): 97 (35.4%) treated medically and 177 (64.6%) treated with balloon aortic valvuloplasty; and group 2 (surgical): 88 (24.3%). The medical/balloon aortic valvuloplasty group had significantly higher clinical risk compared with the surgical group, with significantly higher Society of Thoracic Surgeons score (12.8±7.0 versus 8.5±5.1; P<0.001) and logistic European System for Cardiac Operative Risk Evaluation (EuroSCORE) (42.4±22.8 versus 24.4±18.1; P<0.001). The medical/balloon aortic valvuloplasty group had a higher New York Heart Association functional class, incidence of renal failure, and lower ejection fraction. During median follow-up of 377.5 days, mortality in the medical/balloon aortic valvuloplasty group was 102 (37.2%), and during median follow-up of 386 days, mortality in the surgical group was 19 (21.5%). Multivariable adjustment analysis identified renal failure (hazard ratio [HR]: 5.60), New York Heart Association class IV (HR: 5.88), and aortic systolic pressure (HR: 0.99) as independent correlates for mortality in the medical group, whereas renal failure (HR: 7.45), Society of Thoracic Surgeons score (STS; HR: 1.09) and logistic EuroSCORE (HR: 1.45) were correlates of mortality in the in the surgical group., Conclusions: Patients with severe symptomatic aortic stenosis not included in transcatheter aortic valve implantation trials do poorly and have extremely high mortality rates, especially in nonsurgical groups, and loss of quality of life in surgical groups.