Patient Characteristics and Outcomes Associated with Sentinel Protection Device Use in Patients with Aortic Valve Disease Undergoing TAVR in a "Real-World" Setting.

Background: Transcatheter aortic valve replacement (TAVR) has become the dominant treatment for aortic valve disease. While TAVR safety has improved over time, concern remains over the occurrence of cerebrovascular accidents (CVA) secondary to device placement, which is associated with increased morbidity and mortality. The Sentinel Cerebral Protection System (CPS) was developed to reduce the risk of embolic strokes associated with debris produced during TAVR. Studies evaluating Sentinel CPS efficacy have produced conflicting results, and there is little understanding of which patients are selected for device placement in "real-world" settings. With no existing guidelines on device use, the purpose of this study was to describe and compare the characteristics of patients who receive CPS with those who do not in a "real-world" setting of consecutive TAVR patients and evaluate its impact on postoperative complications, namely stroke. Methods: This was a single-center, retrospective study of all patients undergoing TAVR between July 1, 2019, and December 31, 2020. Patient demographics, baseline, and perioperative characteristics were collected prospectively using the Society of Thoracic Surgeons (STS)/American College of Cardiology (ACC) Transcatheter Valve Therapy (TVT) Registry and our institution's TAVR database for analysis. Postoperative outcomes were assessed using primary endpoints of in-hospital/30-day stroke and the composite of death, stroke, and bleeding/vascular events at one-year. To adjust for baseline differences, a propensity score was developed including all factors that were different between groups, and Multivariate Cox Regression analysis was used to control for these differences. Patient follow-up was 97% complete at 12 months with 100% echocardiographic follow-up. Results: A total of 242 consecutive patients (57.9% male) were analyzed, with a mean age of 79.9 ± 9 years. Of these patients, 134 (55.4%) received the Sentinel CPS and 108 (44.6%) did not. Sentinel CPS patients were more likely to be male, not on dialysis, without prior CVA or pacemaker, had less severe chronic lung disease, and were lower operative risk compared to concurrent non-CPS patients. CPS patients were also found to have higher hemoglobin and albumin levels, lower creatinine, and were less likely to be on immunosuppressant therapy. The incidence of in-hospital/30-day stroke after TAVR did not differ between CPS and non-CPS patients (0.0% vs. 1.9%; p = 0.198). Unadjusted analyses at one-year showed a lower occurrence of the composite endpoint in CPS patients compared non-CPS patients (8.3% vs. 17.0%; p = 0.034). After adjustment, the hazard ratio (Adj HR) for the CPS group was no longer significantly associated with a lower composite endpoint (Adj HR = 0.609, 95% CI 0.244-1.523; p = 0.289). Both unadjusted (p = 0.233) and adjusted (p = 0.132) analyses showed no difference in the incidence of stroke at one-year. Conclusions: Our study demonstrates that in a "real-world" setting, the Sentinel CPS device is more likely to be used in healthier and less complex patients. In analyses adjusted for illness severity and patient complexity, CPS use did not have a significant effect on the incidence of in-hospital/30-day stroke or the composite endpoint of death, stroke, and bleeding/vascular events at one-year.

The Danish-American Research Exchange (DARE): a cross-sectional study of a binational research education program.

BACKGROUND: Most medical educational programs emphasize clinical observation or clinical skill acquisition, fewer focus upon research. The Danish-American Research Exchange (DARE) program, sponsored by the Lundbeck Foundation, is unique in that the medical student initiates biomedical research collaboration between Danish and US medical institutions. To achieve this, Danish medical students (DARE students) conduct binational mentored research projects while based in the United States for 10 months. In addition, DARE students are introduced to interdisciplinary thinking about how to develop ultra-low-cost healthcare interventions through the '$10 Challenge'. METHODS: We conducted a cross-sectional study of DARE alumni over five consecutive years (2015-2020, n = 24). Research metrics included completion of a research project, primary authorship, and co-authorship of publications. The number of publications, prior to and after the DARE program were enumerated. For the first four cohorts, graduation from medical school and acceptance or intention to enter a joint MD-PhD program also were assessed. Two focus groups were conducted using constructivist grounded theory. Discussions were transcribed, redacted, and coded using Dedoose software. RESULTS: DARE Medical students were 31.2 years (range 24-35), the majority were women (67%;16/24). The majority (17/24;71%) completed a first author publication in a peer-reviewed journal with a median of 3.9 per DARE alumnus. DARE alumnus reported increased proficiency in biostatistics, epidemiology, coding and public speaking as well as stronger research qualities in creativity, critical thinking, comfort in approaching scientist in both the US and Denmark (p < 0.001 for all). Qualitative key themes included: increased confidence, a deepening of research inquiry and linkage to a research network. CONCLUSIONS: Preliminarily, this study suggests that medical students can initiate binational collaboration in medicine. Benefits include research productivity, intention to pursue academic medical careers, as well as positive impacts on motivation. This medical student-initiated research model lays the groundwork for using this model across other country pairs to promote binational collaboration.

Left ventricular end-systolic volume response post-stress echocardiography: Dilation as a marker of multi-vessel coronary artery disease.

BACKGROUND: Transient ischemic dilation of the left ventricle (LV) during stress echocardiography indicates extensive myocardial ischemia. It remains unclear whether the change of LV end-systolic volume (ESV) or end-diastolic volume (EDV) better correlated with significant coronary artery disease (CAD). Meanwhile, the clinical significance of the extent of the volumetric change post-stress has not been investigated. METHODS: One hundred and five individuals (62 ± 12 years and 75% men) who underwent coronary angiography following exercise treadmill echocardiography were enrolled retrospectively. An additional 30 age- and sex-matched healthy subjects were included for comparison. LV dilation was defined as any increase in LV volume from rest to peak exercise. Patients who had at least two coronary arteries with significant stenosis were considered as having multi-vessel CAD. RESULTS: Thirty-four patients had ESV dilation during exercise echocardiography. On the contrary, ESV decreased at peak exercise in all healthy subjects. Forty-one patients had multi-vessel CAD, and its prevalence was higher in patients with ESV dilation (65% vs 27%, p = 0.001). The extent of ESV increase correlated with CAD severity. ESV dilation is associated with multi-vessel CAD (Odds ratio [OR] 5.02, 95% confidence interval [CI] 2.09 - 12.07, p < 0.001). After adjustment for EDV increase, clinical, electrocardiographic, and echocardiographic variables, the association remained significant (adjusted OR 5.57, 95% CI 1.37-22.64; p = 0.02). CONCLUSIONS: ESV dilation independently correlated with multi-vessel CAD, whereas EDV dilation did not. The amount of ESV increase correlated with the severity of CAD. Our findings provide a rationale for incorporating volume measurements into stress echocardiography practice.

Who is young at heart and when? Diastolic Doppler data from the mind your heart study.

To further define the age-related distribution of diastolic function as defined by E/A ratio, in healthy male adults. The age-sensitive ratio of mitral inflow E-wave to A-wave (E/A) velocity is often considered in the evaluation of diastolic function. To appropriately direct a comprehensive evaluation of diastolic function, we sought to improve the characterization of the influence of age on E/A ratio. We analyzed echocardiographic data from the Mind Your heart Study, a cohort of outpatients recruited from two San Francisco Veterans centers to examine the effect of mental health on cardiovascular outcomes. Individuals with a history of heart disease or hypertension were excluded, leaving 313 veterans for analysis. We examined E/A by 5-year increments and performed linear and logistic regression analysis to predict trends in E/A and E dominance. Within the age ranges of population (54.9 ± 11.5), there is a steady gradual decline in absolute E/A ratio (beta coefficient/year- 0.018, P < .001) and the odds of E dominance similarly declines with age (odds ratio/year = 0.89, P < .001). Despite this decline, 90% of individuals below the age of 50 years maintain E dominance. Beyond age 50, 55% maintain E dominance, and beyond age 70, only 28% have E dominance. In this adequately healthy population, age-related progression of delayed relaxation appears to be a state of normality rather than diastolic dysfunction. Careful attention to specific cutoff points in age and E/A ratio could avoid misinterpretation or inappropriate management.

Quantifying the utilization of medical devices necessary to detect postmarket safety differences: A case study of implantable cardioverter defibrillators.

PURPOSE: To estimate medical device utilization needed to detect safety differences among implantable cardioverter defibrillators (ICDs) generator models and compare these estimates to utilization in practice. METHODS: We conducted repeated sample size estimates to calculate the medical device utilization needed, systematically varying device-specific safety event rate ratios and significance levels while maintaining 80% power, testing 3 average adverse event rates (3.9, 6.1, and 12.6 events per 100 person-years) estimated from the American College of Cardiology's 2006 to 2010 National Cardiovascular Data Registry of ICDs. We then compared with actual medical device utilization. RESULTS: At significance level 0.05 and 80% power, 34% or fewer ICD models accrued sufficient utilization in practice to detect safety differences for rate ratios <1.15 and an average event rate of 12.6 events per 100 person-years. For average event rates of 3.9 and 12.6 events per 100 person-years, 30% and 50% of ICD models, respectively, accrued sufficient utilization for a rate ratio of 1.25, whereas 52% and 67% for a rate ratio of 1.50. Because actual ICD utilization was not uniformly distributed across ICD models, the proportion of individuals receiving any ICD that accrued sufficient utilization in practice was 0% to 21%, 32% to 70%, and 67% to 84% for rate ratios of 1.05, 1.15, and 1.25, respectively, for the range of 3 average adverse event rates. CONCLUSIONS: Small safety differences among ICD generator models are unlikely to be detected through routine surveillance given current ICD utilization in practice, but large safety differences can be detected for most patients at anticipated average adverse event rates.

Beta-blocker subtype and risks of perioperative adverse events following non-cardiac surgery: a nationwide cohort study.

AIMS: Beta-blockers vary in pharmacodynamics and pharmacokinetic properties. It is unknown whether specific types are associated with increased perioperative risks. We evaluated perioperative risks associated with beta-blocker subtypes, overall and in patient subgroups. METHODS AND RESULTS: We performed a Danish Nationwide cohort study, 2005-2011, of patients treated chronically with beta blocker (atenolol, bisoprolol, carvedilol, metoprolol, propranolol, or other) prior to non-cardiac surgery. Risks of 30-day all-cause mortality (ACM) and 30-day major adverse cardiovascular events (MACE) were estimated using adjusted logistic regression models and odds ratios with 95% confidence intervals. We identified 61 660 patients, most frequently treated with metoprolol (67% of patients, mean age 69 years, 49% males), atenolol (10% of patients, mean age 68 years, 36% males), or carvedilol (9% of patients, mean age 68 years, 60% males). The crude incidences of ACM and MACE were 4.1 and 3.5% in patients with metoprolol, 3.0 and 2.3% with atenolol, and 4.8 and 4.6% with carvedilol. In adjusted models, risks were not significantly different with atenolol (ACM; 1.10 [0.92-1.32], MACE; 1.08 [0.90-1.31]) or carvedilol (ACM; 0.99 [0.85-1.16], MACE; 1.07 [0.92-1.25]), compared with metoprolol. Risks of ACM were significantly lower in prior myocardial infarction patients treated with carvedilol (0.62 [0.43-0.87]) and no different in patients with uncomplicated hypertension (1.41 [0.83-2.40]). Risks did not differ in analyses stratified by age, surgery priority, duration of anaesthesia or surgery risk (all P for interaction >0.05). CONCLUSION: Risks of ACM and MACE did not systematically differ by beta-blocker subtype. Findings may guide clinical practice and future trials.

Percutaneous coronary intervention versus coronary artery bypass grafting: where are we after NOBLE and EXCEL?

PURPOSE OF REVIEW: The publication of the NOBLE and EXCEL trials, with seemingly conflicting results, brought into question whether percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) is better for low-risk patients with left main coronary artery stenosis (LMCAS). This review appraises the methods and results of NOBLE and EXCEL, contextualizes them within the literature, and determines how they may affect clinical practice. RECENT FINDINGS: We appraised the trials and describe differences in methodology and results. NOBLE recruited primarily isolated LMCAS, and found that CABG was superior to PCI. EXCEL's population included patients LMCAS in the context of multivessel CAD, and found PCI and CABG were comparable. Both trials enrolled young patients with few comorbidities, and there was more protocol-mandated consistency in the procedural techniques and medical therapy of patients receiving PCI. SUMMARY: The generalizability of these trials is limited by the use of young, healthy patients at highly skilled centres that rarely reflect typical clinical practice. If these studies are to maintain relevance, trialists must address the lack of protocolization of surgical interventions and inconsistent medical therapies. Unfortunately, the limitations of NOBLE and EXCEL mean that we are no closer to answering the question of what is the optimal treatment for patients with LMCAS.

Implementing a protocol to optimize blood use in a cardiac surgery service: results of a pre-post analysis and the impact of high-volume blood users.

BACKGROUND: Blood transfusions are a common and costly intervention for cardiac surgery patients. Evidence suggests that a more restrictive transfusion strategy may reduce costs and transfusion-related complications without increasing perioperative morbidity and mortality. STUDY DESIGN AND METHODS: A transfusion-limiting protocol was developed and implemented in a cardiovascular surgery unit. Over a 5-year period, data were collected on patient characteristics, procedures, utilization of blood products, morbidity, and mortality, and these were compared before and after the protocol was implemented. RESULTS: After the protocol was put in place, fewer patients required transfusions (38.2% vs. 45.5%, p = 0.004), with the greatest reduction observed in postoperative blood use (29.1% vs. 37.2%, p = 0.001). In-hospital morbidity and mortality did not increase. When patients who received transfusions were stratified by procedure, the protocol was most effective in reducing transfusions for patients undergoing isolated coronary artery bypass grafting (CABG; 4.09 units vs. 2.51 units, p = 0.009) and CABG plus valve surgery (10.32 units vs. 4.77 units, p = 0.014). A small group of patients were disproportionate recipients of transfusions, with approximately 6% of all patients receiving approximately half of the blood products. CONCLUSION: A protocol to limit transfusions decreased the proportion of cardiothoracic surgery patients who received blood products. A very small group of patients received a large number of transfusions, and within that group the observed mortality was significantly higher than in the general patient population. Current protocols cannot possibly account for these patients, and this should be considered when analyzing the performance of protocols designed to reduce unnecessary transfusions.

Safety and clinical effectiveness of drug-eluting stents for saphenous vein graft intervention in older individuals: Results from the medicare-linked National Cardiovascular Data Registry(®) CathPCI Registry(®) (2005-2009).

OBJECTIVES: To evaluate the safety of drug-eluting stents (DES) when treating patients with failing saphenous vein grafts (SVG). BACKGROUND: DES reduce target vessel revascularization in patients with failing SVGs; however, compared with bare metal stents (BMS), DES have been variably associated with increased mortality. METHODS: Clinical records from National Cardiovascular Data Registry(®) CathPCI Registry(®) (49,325 older individuals [≥65 years] who underwent SVG stenting 2005-2009) were linked to Medicare claims to create a longitudinal record. Death, myocardial infarction (MI), and urgent revascularization with DES versus BMS were evaluated to 3 years using propensity matching (PM). Results were stratified by clinical presentation (acute coronary syndrome [ACS], non-ACS), previous lesion treatment (in-stent, de novo), and graft segment (aortic, body, distal anastomosis). RESULTS: In this older cohort (median age, 75 years), acute presentations were prevalent (ACS, 69%; TIMI flow <3, 45%), and adverse clinical outcomes were common by 3 years (death, 24.5%; MI, 14.6%; urgent revascularization, 29.5%). Among DES patients (n = 31,403), 3-year mortality was lower (vs. BMS) (22.7% vs. 28.0%, P < 0.001; PM hazard ratio [HR] 0.87, 95% confidence interval 0.83-0.91), and no difference was observed in the adjusted risk for MI (PM HR 0.97, 0.91 to 1.03) or urgent revascularization (PM HR 1.04, 0.99-1.08). These findings were independent of clinical presentation, previous lesion treatment, and graft segment (P interaction, ns). CONCLUSIONS: In this large SVG PCI cohort, all-cause mortality was lower among those receiving DES, and no difference in MI or urgent revascularization was observed to 3 years. © 2015 Wiley Periodicals, Inc.

Comparative effectiveness of revascularization strategies.

BACKGROUND: Questions persist concerning the comparative effectiveness of percutaneous coronary intervention (PCI) and coronary-artery bypass grafting (CABG). The American College of Cardiology Foundation (ACCF) and the Society of Thoracic Surgeons (STS) collaborated to compare the rates of long-term survival after PCI and CABG. METHODS: We linked the ACCF National Cardiovascular Data Registry and the STS Adult Cardiac Surgery Database to claims data from the Centers for Medicare and Medicaid Services for the years 2004 through 2008. Outcomes were compared with the use of propensity scores and inverse-probability-weighting adjustment to reduce treatment-selection bias. RESULTS: Among patients 65 years of age or older who had two-vessel or three-vessel coronary artery disease without acute myocardial infarction, 86,244 underwent CABG and 103,549 underwent PCI. The median follow-up period was 2.67 years. At 1 year, there was no significant difference in adjusted mortality between the groups (6.24% in the CABG group as compared with 6.55% in the PCI group; risk ratio, 0.95; 95% confidence interval [CI], 0.90 to 1.00). At 4 years, there was lower mortality with CABG than with PCI (16.4% vs. 20.8%; risk ratio, 0.79; 95% CI, 0.76 to 0.82). Similar results were noted in multiple subgroups and with the use of several different analytic methods. Residual confounding was assessed by means of a sensitivity analysis. CONCLUSIONS: In this observational study, we found that, among older patients with multivessel coronary disease that did not require emergency treatment, there was a long-term survival advantage among patients who underwent CABG as compared with patients who underwent PCI. (Funded by the National Heart, Lung, and Blood Institute.).

Effects of a protocol-based management of type A aortic dissections.

BACKGROUND: Ascending aortic dissections (AADs) require prompt diagnosis and surgical treatment. We present the results of implementing a multidisciplinary aortic dissection protocol on the outcomes of AAD treatment at a nonteaching hospital. METHODS: From January 2002-December 2013, 54 patients with the diagnosis of AAD were treated at our institution. Thirty-seven (68.5%) were male with a mean age of 62.3 y. Cardiogenic shock was present in 25.9% of patients. An AAD protocol, focused on educating physicians on presenting signs and symptoms, adequate triaging, and the need for immediate surgical intervention, was implemented, alongside the standardization of surgical treatment. We divided the cohort into two eras, based on AAD program's implementation in 2006, to better assess the impact of this protocol. RESULTS: Patients from the early era had significantly longer time from Emergency Department to the operating room, more postoperative occurrence of prolonged ventilation, and a longer postoperative hospital stay at 8.7 ± 8 versus 3.1 ± 2.6 h (P = 0.002), 63% versus 18% (P = 0.002), and 63% versus 18% (P = 0.002), respectively. The overall mortality for the cohort was 9.3%, decreasing from 12.5% before 2006 to 7.9% after 2006. CONCLUSIONS: The implementation of a multidisciplinary aortic dissection protocol has resulted in faster diagnosis and transport of AAD cases from the emergency room to the operating room, improving outcomes. Our data support the concept that nonteaching institutions can deliver excellent care to patients with acute aortic emergencies.

Circulating soluble receptor for advanced glycation end product identifies patients with bicuspid aortic valve and associated aortopathies.

OBJECTIVE: A total of 30% to 50% of patients with bicuspid aortic valve (BAV) require surgery for aortic valve replacement (AVR), ascending aortic replacement (AA), or both. To prevent adverse aortic events, they are risk stratified using imperfect criteria based on imaging modalities. As a result, a significant number of dissections occur outside of the parameters suggested by the guidelines. Advanced glycation end products (AGEs) are associated with valve and vascular remodeling and trigger the release of a soluble receptor (soluble receptor for advanced glycation end product [sRAGE]). This study aims to characterize sRAGE as a diagnostic and risk-stratification tool for patients with BAV referred for surgery. APPROACH AND RESULTS: sRAGE was measured in 135 patients (BAV, n=74; tricuspid aortic valve, n=61) meeting inclusion criteria from 338 enrolled patients undergoing AVR and AA. Univariate and multivariate analyses were performed. sRAGE level was significantly associated with the presence of BAV, independent of age, sex, and common risk factors for vascular disease (P<0.001). Within the BAV cohort, patients referred for AA and AVR had higher sRAGE values than patients undergoing AVR only (P=0.002). Patients with BAV <60 years of age, presenting with both valve and aortic diseases (fast progressors), had higher sRAGE than older patients who only needed AVR (slow progressors). Histological analysis showed that sRAGE correlates with dysfunctional aortic microstructure and does not correlate with aortic diameter (R(2)=0.007; P=0.51) or diameter/body surface area (R(2)=0.011; P=0.42). CONCLUSIONS: These results show that elevated level of circulating sRAGE is associated with the presence of BAV and associated aortopathies, independent of aortic diameter.

Acute kidney injury treated with renal replacement therapy and 5-year mortality after myocardial infarction-related cardiogenic shock: a nationwide population-based cohort study.

BACKGROUND: Myocardial infarction-related cardiogenic shock is frequently complicated by acute kidney injury. We examined the influence of acute kidney injury treated with renal replacement therapy (AKI-RRT) on risk of chronic dialysis and mortality, and assessed the role of comorbidity in patients with cardiogenic shock. METHODS: In this Danish cohort study conducted during 2005-2012, we used population-based medical registries to identify patients diagnosed with first-time myocardial infarction-related cardiogenic shock and assessed their AKI-RRT status. We computed the in-hospital mortality risk and adjusted relative risk. For hospital survivors, we computed 5-year cumulative risk of chronic dialysis accounting for competing risk of death. Mortality after discharge was computed with use of Kaplan-Meier methods. We computed 5-year hazard ratios for chronic dialysis and death after discharge, comparing AKI-RRT with non-AKI-RRT patients using a propensity score-adjusted Cox regression model. RESULTS: We identified 5079 patients with cardiogenic shock, among whom 13% had AKI-RRT. The in-hospital mortality was 62% for AKI-RRT patients, and 36% for non-AKI-RRT patients. AKI-RRT remained associated with increased in-hospital mortality after adjustment for confounders (relative risk=1.70, 95% confidence interval (CI): 1.59-1.81). Among the 3059 hospital survivors, the 5-year risk of chronic dialysis was 11% (95% CI: 8-16%) for AKI-RRT patients, and 1% (95% CI: 0.5-1%) for non-AKI-RRT patients (adjusted hazard ratio: 15.9 (95% CI: 8.7-29.3). The 5-year mortality was 43% (95% CI: 37-53%) for AKI-RRT patients compared with 29% (95% CI: 29-31%) for non-AKI-RRT patients. The adjusted 5-year hazard ratio for death was 1.55 (95% CI: 1.22-1.96) for AKI-RRT patients compared with non-AKI-RRT patients. In patients with comorbidity, absolute mortality increased while relative impact of AKI-RRT on mortality decreased. CONCLUSION: AKI-RRT following myocardial infarction-related cardiogenic shock predicted elevated short-term mortality and long-term risk of chronic dialysis and mortality. The impact of AKI-RRT declined with increasing comorbidity suggesting that intensive treatment of AKI-RRT should be accompanied with optimized treatment of comorbidity when possible.

Comparative genome-wide transcriptional analysis of human left and right internal mammary arteries.

In coronary artery bypass grafting (CABG), the combined use of left and right internal mammary arteries (LIMA and RIMA) - collectively known as bilateral IMAs (BIMAs) provides a survival advantage over the use of LIMA alone. However, gene expression in RIMA has never been compared to that in LIMA. Here we report a genome-wide transcriptional analysis of BIMA to investigate the expression profiles of these conduits in patients undergoing CABG. As expected, in comparing the BIMAs to the aorta, we found differences in pathways and processes associated with atherosclerosis, inflammation, and cell signaling - pathways which provide biological support for the observation that BIMA grafts deliver long-term benefits to the patients and protect against continued atherosclerosis. These data support the widespread use of BIMAs as the preferred conduits in CABG.

Effect of race and ethnicity on outcomes with drug-eluting and bare metal stents: results in 423 965 patients in the linked National Cardiovascular Data Registry and centers for Medicare & Medicaid services payer databases.

BACKGROUND: Black, Hispanic, and Asian patients have been underrepresented in percutaneous coronary intervention clinical trials; therefore, there are limited data available on outcomes for these race/ethnicity groups. METHODS AND RESULTS: We examined outcomes in 423 965 patients in the National Cardiovascular Data Registry CathPCI Registry database linked to Medicare claims for follow-up. Within each race/ethnicity group, we examined trends in drug-eluting stent (DES) use, 30-month outcomes, and relative outcomes of DES versus bare metal stents. Overall, 390 351 white, 20 191 black, 9342 Hispanic, and 4171 Asian patients > 65 years of age underwent stent implantation from 2004 through 2008 at 940 National Cardiovascular Data Registry participating sites. Trends in adoption of DES were similar across all groups. Relative to whites, black and Hispanic patients undergoing percutaneous coronary intervention had higher long-term risks of death and myocardial infarction (blacks: hazard ratio, 1.28; 95% confidence interval, 1.24-1.32; Hispanics: hazard ratio, 1.15; 95% confidence interval, 1.10-1.21). Long-term outcomes were similar in Asians and whites (hazard ratio, 0.99; 95% confidence interval, 0.92-1.08). Use of DES was associated with better 30-month survival and lower myocardial infarction rates compared with the use of bare metal stents among all race/ethnicity groups except Hispanics, who had similar outcomes with DES or bare metal stents. CONCLUSIONS: Black and Hispanic patients undergoing percutaneous coronary intervention had worse long-term outcomes relative to white and Asian patients. Compared with bare metal stent use, DES use was generally associated with superior long-term outcomes in all racial and ethnic groups, although these differences were not statistically significant in Hispanic patients.

Blood transfusion in cardiac surgery does increase the risk of 5-year mortality: results from a contemporary series of 1714 propensity-matched patients.

BACKGROUND: Studies have found that cardiac surgery patients receiving blood transfusions are at risk for increased mortality during the first year after surgery, but risk appears to decrease after the first year. This study compared 5-year mortality in a propensity-matched cohort of cardiac surgery patients. STUDY DESIGN AND METHODS: Between July 1, 2004, and June 30, 2011, 3516 patients had cardiac surgery with 1920 (54.6%) requiring blood transfusion. Propensity matching based on 22 baseline characteristics yielded two balanced groups (blood transfusion group [BTG] and nontransfused control group [NCG]) of 857 patients (1714 in total). The type and number of blood products were compared in the BTG. RESULTS: Operative mortality was higher in BTG versus NCG (2.3% vs. 0.4%; p < 0.0001). Kaplan-Meier analysis of 5-year survival demonstrated no difference between groups in the first 2 years (BTG 96.3% and 93.0% vs. NCG 96.4% and 93.9%, respectively). There was a significant divergence during Years 3 to 5 (BTG 82.0% vs. NCG 89.3% at 5 years; p < 0.007). Five-year survival was significantly lower in patients who received at least 2 units of blood (79.6% vs. 88.0%; p < 0.0001). In multivariate Cox regression analyses, transfusion was independently associated with increased risk for 5-year mortality. Patients receiving cryoprecipitate products had a twofold mortality risk increase (adjusted hazard ratio, 2.106; p = 0.002). CONCLUSION: Blood transfusion, specifically cryoprecipitates, was independently associated with increased 5-year mortality. Transfusion during cardiac surgery should be limited to patients who are in critical need of blood products.

EUS-FNA is superior to ERCP-based tissue sampling in suspected malignant biliary obstruction: results of a prospective, single-blind, comparative study.

BACKGROUND: Both EUS and ERCP sampling techniques may provide tissue diagnoses in suspected malignant biliary obstruction. However, there are scant data comparing these 2 methods. OBJECTIVE: To compare EUS-guided FNA (EUS-FNA) and ERCP tissue sampling for the diagnosis of malignant biliary obstruction. DESIGN: Prospective, comparative, single-blind study. SETTING: Tertiary center. PATIENTS: Fifty-one patients undergoing same-session EUS and ERCP for the evaluation of malignant biliary obstruction over a 1-year period. INTERVENTIONS: EUS-FNA and ERCP tissue sampling with biliary brush cytology and intraductal forceps biopsies. MAIN OUTCOME MEASUREMENTS: Diagnostic sensitivity and accuracy of each sampling method compared with final diagnoses. RESULTS: EUS-FNA was more sensitive and accurate than ERCP tissue sampling (P < .0001) in 51 patients with pancreatic cancers (n = 34), bile duct cancers (n = 14), and benign biliary strictures (n = 3). The overall sensitivity and accuracy were 94% and 94% for EUS-FNA, and 50% and 53% for ERCP sampling, respectively. EUS-FNA was superior to ERCP tissue sampling for pancreatic masses (sensitivity, 100% vs 38%; P < .0001) and seemed comparable for biliary masses (79% sensitivity for both) and indeterminate strictures (sensitivity, 80% vs 67%). LIMITATIONS: Single-center study. CONCLUSION: EUS-FNA is superior to ERCP tissue sampling in evaluating suspected malignant biliary obstruction, particularly for pancreatic masses. EUS-FNA appears similar to ERCP sampling for biliary tumors and indeterminate strictures. Given the superior performance characteristics of EUS-FNA and the higher incidence of pancreatic cancer compared with cholangiocarcinoma, EUS-FNA should be performed before ERCP in all patients with suspected malignant biliary obstruction. ( CLINICAL TRIAL REGISTRATION NUMBER: NCT01356030.).

Comparative safety of periablation anticoagulation strategies for atrial fibrillation: data from a large multicenter study.

BACKGROUND: There are a variety of periprocedural anticoagulation strategies for atrial fibrillation (AF) ablation, including the use of dabigatran. It is unclear which strategy is superior. OBJECTIVE: To compare the safety and efficacy of anticoagulation with uninterrupted warfarin, dabigatran, and warfarin with heparin bridging in patients undergoing ablation of AF at four experienced centers. METHODS AND RESULTS: In this retrospective analysis, 882 patients (mean age: 61 ± 11 years) underwent ablation of AF using uninterrupted warfarin (n = 276), dabigatran (n = 374), or warfarin with heparin bridging (n = 232) for periprocedural anticoagulation. The rate of total complications was 23/276 (8.3%) in the uninterrupted warfarin group, 30/374 (8.0%) in the dabigatran group, and 29/232 (12.5%) in the bridged group (P = 0.15). Major complications were more frequent in the uninterrupted warfarin group 12/276 (4.3%) compared with 3/374 (0.8%) in dabigatran and 6/232 (2.6%) in the bridged group (P = 0.01). The most common major complication was the need for transfusion or occurrence of major bleeding. Minor complications did not differ among the three groups. On multivariate analysis, female gender (odds ratio [OR] 1.93, confidence interval [CI] 1.16-3.19, P = 0.011), bridging heparin (OR 2.13, CI 1.100-3.941, P = 0.016), use of triple antithrombotic therapy (OR 1.77, CI 1.05-2.98, P = 0.033), and prior myocardial infarction (OR 2.40, CI 1.01-5.67, P = 0.046) independently predicted total complications. CONCLUSIONS: When comparing the use of uninterrupted warfarin, dabigatran, and warfarin with heparin bridging in patients undergoing catheter ablation of AF, dabigatran was not associated with increased risk, major complications were more common in the uninterrupted warfarin group, and after adjustment, warfarin with bridging increased total complications.

Mutational analysis clopidogrel resistance and platelet function in patients scheduled for coronary artery bypass grafting.

Clopidogrel is an oral antiplatelet pro-drug prescribed to 40 million patients worldwide who are at risk for thrombotic events or receiving percutaneous coronary intervention (PCI). However about a fifth of patients treated with clopidogrel do not respond adequately to the drug. From a cohort of 105 patients on whom we had functional data on clopidogrel response, we used ultra-high throughput sequencing to assay mutations in CYP2C19 and ABCB1, the two genes genetically linked to respond. Testing for mutations in CYP2C19, as recommended by the FDA, only correctly predicted if a patient would respond to clopidogrel 52.4% of the time. Similarly, testing of the ABCB1 gene only correctly foretold response in 51 (48.6%) patients. These results are clinically relevant and suggest that until additional genetic factors are discovered that predict response more completely, functional assays are more appropriate for clinical use.

Defining the blanking period, using continuous ECG monitoring, after cryoballoon pulmonary vein isolation.

BACKGROUND: Pulmonary vein isolation (PVI) is the cornerstone of atrial fibrillation (AF) ablation. A blanking period (BP) of 3 months is used in clinical trials and practice. However, the optimal BP duration after PVI remains undefined. OBJECTIVE: The aim of this study was to objectively define, using continuous monitoring by an implantable loop recorder, the optimal BP duration after cryoballoon PVI. METHODS: We enrolled consecutive patients who had cryoballoon PVI and an implantable loop recorder. We determined the time of the last confirmed episode of AF within the blanking period. This was then correlated with AF recurrence in the first year after ablation. RESULTS: There were 210 patients (66 ± 9 years; 138 [66%] male; 116 [55%] paroxysmal AF; CHA2DS2-VASc score, 2.5 ± 1.6). We defined 4 distinct groups based on the last AF episode within the BP: no AF days 0-90 (n = 96 [46%]) and last AF 0-30 days (n = 46 [22%]), 31-60 days (n = 18 [9%]), and 61-90 days (n = 50 [24%]). After the 3-month BP, 101 (48%) patients had AF recurrence at 160 ± 86 days. Compared with patients with no AF in the BP, those with recurrent AF and AF burden >0% 30 days after ablation had a significantly greater AF recurrence during long-term follow-up (P = .001). CONCLUSION: Our data show that the approximately one-third of patients in whom AF occurs and who have a burden of >0% after the first month that follows PVI are at significantly higher risk of long-term recurrent AF. We therefore suggest that the blanking period be limited to a month after cryoballoon PVI.