Diastolic dysfunction and clinical outcomes after transcatheter or surgical aortic valve replacement in patients with atypical aortic valve stenosis.

BACKGROUND: Diastolic dysfunction is a predictor of poor outcomes in many cardiovascular conditions. At present, it is unclear whether diastolic dysfunction predicts adverse outcomes in patients with atypical aortic stenosis who undergo aortic valve replacement (AVR). METHODS: Five hundred and twenty-three patients who underwent transcatheter AVR (TAVR) (n = 303) and surgical AVR (SAVR) (n = 220) at a single institution were included in our analysis. Baseline left and right heart invasive hemodynamics were assessed. Baseline transthoracic echocardiograms were reviewed to determine aortic stenosis subtype and parameters of diastolic dysfunction. Aortic stenosis subtype was categorized as typical (normal flow, high-gradient) aortic stenosis, classical, low-flow, low-gradient (cLFLG) aortic stenosis, and paradoxical, low-flow, low-gradient (pLFLG) aortic stenosis. Cox proportional hazard models were utilized to examine the relation between invasive hemodynamic or echocardiographic variables of diastolic dysfunction, aortic stenosis subtype, and all-cause mortality. Propensity-score analysis was performed to study the relation between aortic stenosis subtype and the composite outcome [death/cerebrovascular accident (CVA)]. RESULTS: The median STS risk was 5.3 and 2.5% for TAVR and SAVR patients, respectively. Relative to patients with typical aortic stenosis, patients with atypical (cLFLG and pLFLG) aortic stenosis displayed a significantly higher prevalence of diastolic dysfunction (LVEDP ≥ 20mmHg, PCWP ≥ 20mmHg, echo grade II or III diastolic dysfunction, and echo-PCWP ≥ 20mmHg) and, independently of AVR treatment modality, had a significantly increased risk of death. In propensity-score analysis, patients with atypical aortic stenosis had higher rates of death/CVA than typical aortic stenosis patients, independently of diastolic dysfunction and AVR treatment modality. CONCLUSION: We demonstrate the novel observation that compared with patients with typical aortic stenosis, patients with atypical aortic stenosis have a higher burden of diastolic dysfunction. We corroborate the worse outcomes previously reported in atypical versus typical aortic stenosis and demonstrate, for the first time, that this observation is independent of AVR treatment modality. Furthermore, the presence of diastolic dysfunction does not independently predict outcome in atypical aortic stenosis regardless of treatment type, suggesting that other factors are responsible for adverse clinical outcomes in this higher risk cohort.

Genetic-Guided Oral P2Y12 Inhibitor Selection and Cumulative Ischemic Events After Percutaneous Coronary Intervention.

BACKGROUND: Genetic-guided P2Y12 inhibitor selection has been proposed to reduce ischemic events by identifying CYP2C19 loss-of-function (LOF) carriers at increased risk with clopidogrel treatment after percutaneous coronary intervention (PCI). A prespecified analysis of TAILOR-PCI (Tailored Antiplatelet Therapy Following PCI) evaluated the effect of genetic-guided P2Y12 inhibitor therapy on cumulative ischemic and bleeding events. OBJECTIVES: Here, the authors detail a prespecified analysis of cumulative endpoints. The primary endpoint was cumulative incidence rate of ischemic events at 12 months. Cumulative incidence of major and minor bleeding was a secondary endpoint. Cox proportional hazards models as adapted by Wei, Lin, and Weissfeld were used to estimate the effect of this strategy on all observed events. METHODS: The TAILOR-PCI trial was a prospective trial including 5,302 post-PCI patients with acute and stable coronary artery disease (CAD) who were randomized to genetic-guided P2Y12 inhibitor or conventional clopidogrel therapy. In the genetic-guided group, LOF carriers were prescribed ticagrelor, whereas noncarriers received clopidogrel. TAILOR-PCI's primary analysis was time to first event in LOF carriers. RESULTS: Among 5,276 patients (median age 62 years; 25% women; 82% acute CAD; 18% stable CAD), 1,849 were LOF carriers (903 genetic-guided; 946 conventional therapy). The cumulative primary endpoint was significantly reduced in the genetic-guided group compared with the conventional therapy (HR: 0.61; 95% CI: 0.41-0.89; P = 0.011) with no significant difference in cumulative incidence of major or minor bleeding (HR: 1.36; 95% CI: 0.67-2.76; P = 0.39). CONCLUSIONS: Among CYP2C19 LOF carriers undergoing PCI, a genetic-guided strategy resulted in a statistically significant reduction in cumulative ischemic events without a significant difference in bleeding. (Tailored Antiplatelet Therapy Following PCI [TAILOR-PCI]; NCT01742117).

Diazoxide Choline Extended-Release Tablet in People With Prader-Willi Syndrome: A Double-Blind, Placebo-Controlled Trial.

CONTEXT: Prader-Willi syndrome (PWS) is a rare neurobehavioral-metabolic disease caused by the lack of paternally expressed genes in the chromosome 15q11-q13 region, characterized by hypotonia, neurocognitive problems, behavioral difficulties, endocrinopathies, and hyperphagia resulting in severe obesity if not controlled. OBJECTIVE: The primary end point was change from baseline in hyperphagia using the Hyperphagia Questionnaire for Clinical Trials (HQ-CT). Other end points included Global Impression Scores, and changes in body composition, behaviors, and hormones. METHODS: In DESTINY PWS, a 13-week, randomized, double-blind, placebo-controlled, phase 3 trial, 127 participants with PWS aged 4 years and older with hyperphagia were randomly assigned 2:1 to diazoxide choline extended-release tablet (DCCR) or placebo. RESULTS: DCCR did not significantly improve hyperphagia (HQ-CT least-square mean (LSmean) [SE] -5.94 [0.879] vs -4.27 [1.145]; P = .198), but did so in participants with severe hyperphagia (LSmean [SE] -9.67 [1.429] vs -4.26 [1.896]; P = .012). Two of 3 secondary end points were improved (Clinical Global Impression of Improvement [CGI-I]; P = .029; fat mass; P = .023). In an analysis of results generated pre-COVID, the primary (HQ-CT; P = .037) and secondary end points were all improved (CGI-I; P = .015; Caregiver Global Impression of Change; P = .031; fat mass; P = .003). In general, DCCR was well tolerated with 83.3% in the DCCR group experiencing a treatment-emergent adverse event and 73.8% in the placebo group (not significant). CONCLUSION: DCCR did not significantly improve hyperphagia in the primary analysis but did in participants with severe baseline hyperphagia and in the pre-COVID analysis. DCCR treatment was associated with significant improvements in body composition and clinician-reported outcomes.

Point of care CYP2C19 genotyping after percutaneous coronary intervention.

Loss-of-function CYP2C19 variants are associated with increased cumulative ischemic outcomes warranting CYP2C19 genotyping prior to clopidogrel administration. TAILOR-PCI was an international, multicenter (40 sites), prospective, randomized trial comparing rapid point of care (POC) genotype-guided vs. conventional anti-platelet therapy. The performance of buccal-based rapid CYP2C19 genotyping performed by non-laboratory-trained staff in TAILOR-PCI was assessed. Pre-trial training and evaluation involved rapid genotyping of 373 oral samples, with 99.5% (371/373) concordance with Sanger sequencing. During TAILOR-PCI, 5302 patients undergoing PCI were randomized to POC rapid CYP2C19 *2, *3, and *17 genotyping versus no genotyping. At 12 months post-PCI, TaqMan genotyping determined 99.1% (2,364/2,385) concordance with the POC results, with 90.7-98.8% sensitivity and 99.2-99.6% specificity. In conclusion, non-laboratory personnel can be successfully trained for on-site instrument operation and POC rapid genotyping with analytical accuracy and precision across multiple international centers, thereby supporting POC genotyping in patient-care settings, such as the cardiac catheterization laboratory.Clinical Trial Registration: https://www.clinicalTrials.gov (Identifier: NCT01742117).

Clinical characteristics and outcomes of patients with severe left ventricular dysfunction undergoing cardiac MRI viability assessment prior to revascularization.

Coronary artery bypass grafting improves survival in patients with ischemic cardiomyopathy, however, these patients are at high risk for morbidity and mortality. The role of viability testing to guide revascularization in these patients is unclear. Cardiac magnetic resonance imaging (CMR) has not been studied adequately in this population despite being considered a reference standard for infarct imaging. We performed a multicenter retrospective analysis of patients (n = 154) with severe left ventricular systolic dysfunction [ejection fraction (EF) < 35%] on CMR who underwent CMR viability assessment prior to consideration for revascularization. Using the AHA16-segment model, percent total myocardial viability was determined depending on the degree of transmural scar thickness. Patients with or without revascularization had similar clinical characteristics and were prescribed similar medical therapy. Overall, 43% of patients (n = 66) experienced an adverse event during the median 3 years follow up. For the composite outcome (death, myocardial infarction, heart failure hospitalization, stroke, ventricular tachycardia) patients receiving revascularization were less likely to experience an adverse event compared to those without revascularization (HR 0.53, 95% CI 0.33-0.86, p = 0.01). Patients with > 50% viability on CMR had a 47% reduction in composite events when undergoing revascularization opposed to medical therapy alone (HR 0.53, p = 0.02) whereas patients with a viability < 50% were 2.7 times more likely to experience an adverse event (p = 0.01). CMR viability assessment may be an important tool in the shared decision-making process when considering revascularization options in patients with severe ischemic cardiomyopathy.

Effect of Genotype-Guided Oral P2Y12 Inhibitor Selection vs Conventional Clopidogrel Therapy on Ischemic Outcomes After Percutaneous Coronary Intervention: The TAILOR-PCI Randomized Clinical Trial.

Importance: After percutaneous coronary intervention (PCI), patients with CYP2C19*2 or *3 loss-of-function (LOF) variants treated with clopidogrel have increased risk of ischemic events. Whether genotype-guided selection of oral P2Y12 inhibitor therapy improves ischemic outcomes is unknown. Objective: To determine the effect of a genotype-guided oral P2Y12 inhibitor strategy on ischemic outcomes in CYP2C19 LOF carriers after PCI. Design, Setting, and Participants: Open-label randomized clinical trial of 5302 patients undergoing PCI for acute coronary syndromes (ACS) or stable coronary artery disease (CAD). Patients were enrolled at 40 centers in the US, Canada, South Korea, and Mexico from May 2013 through October 2018; final date of follow-up was October 2019. Interventions: Patients randomized to the genotype-guided group (n = 2652) underwent point-of-care genotyping. CYP2C19 LOF carriers were prescribed ticagrelor and noncarriers clopidogrel. Patients randomized to the conventional group (n = 2650) were prescribed clopidogrel and underwent genotyping after 12 months. Main Outcomes and Measures: The primary end point was a composite of cardiovascular death, myocardial infarction, stroke, stent thrombosis, and severe recurrent ischemia at 12 months. A secondary end point was major or minor bleeding at 12 months. The primary analysis was in patients with CYP2C19 LOF variants, and secondary analysis included all randomized patients. The trial had 85% power to detect a minimum hazard ratio of 0.50. Results: Among 5302 patients randomized (median age, 62 years; 25% women), 82% had ACS and 18% had stable CAD; 94% completed the trial. Of 1849 with CYP2C19 LOF variants, 764 of 903 (85%) assigned to genotype-guided therapy received ticagrelor, and 932 of 946 (99%) assigned to conventional therapy received clopidogrel. The primary end point occurred in 35 of 903 CYP2C19 LOF carriers (4.0%) in the genotype-guided therapy group and 54 of 946 (5.9%) in the conventional therapy group at 12 months (hazard ratio [HR], 0.66 [95% CI, 0.43-1.02]; P = .06). None of the 11 prespecified secondary end points showed significant differences, including major or minor bleeding in CYP2C19 LOF carriers in the genotype-guided group (1.9%) vs the conventional therapy group (1.6%) at 12 months (HR, 1.22 [95% CI, 0.60-2.51]; P = .58). Among all randomized patients, the primary end point occurred in 113 of 2641 (4.4%) in the genotype-guided group and 135 of 2635 (5.3%) in the conventional group (HR, 0.84 [95% CI, 0.65-1.07]; P = .16). Conclusions and Relevance: Among CYP2C19 LOF carriers with ACS and stable CAD undergoing PCI, genotype-guided selection of an oral P2Y12 inhibitor, compared with conventional clopidogrel therapy without point-of-care genotyping, resulted in no statistically significant difference in a composite end point of cardiovascular death, myocardial infarction, stroke, stent thrombosis, and severe recurrent ischemia based on the prespecified analysis plan and the treatment effect that the study was powered to detect at 12 months. Trial Registration: ClinicalTrials.gov Identifier: NCT01742117.

Patient Risk Assessment for Transcatheter Aortic Valve Replacement at Veterans Health Administration Hospitals.

OBJECTIVE: To compare patient-level risk assessment at Veterans Affairs (VA) hospitals in patients undergoing transcatheter aortic valve replacement (TAVR) with patients included in the Society for Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy (STS/ACC TVT) registry. METHODS: We retrospectively analyzed the outcomes of veterans with severe aortic stenosis (AS) receiving TAVR from 2012-2016 at eight VA hospitals and compared them with TVT registry outcomes from 2012-2015. Patients were identified via administrative data. Univariable and multivariable Cox proportional hazards models were used to examine 30-day and 1-year all-cause mortality, 30-day and 1-year transient ischemic attack/stroke rates, and permanent pacemaker (PPM) implantation rates. RESULTS: During the study period, a total of 726 veterans underwent TAVR including valve-in-valve procedures (n = 50). Patients were predominantly male (98.2%), with mean age of 78.5 ± 9.3 years; 49.1% were at prohibitive risk and 12.1% were at high risk for surgical aortic valve replacement; 30-day and 1-year all-cause mortality rates were 2.5% and 14.7%, respectively; 30-day and 1-year combined TIA/stroke rates were 6.5% and 13.5%, respectively. In the TVT registry, 15.8% and 37.8% of patients were at prohibitive and high risk, respectively; 30-day and 1-year mortality rates were 5.7% and 22.7%, respectively, and stroke rates were 2.1% and 4.0%, respectively. CONCLUSIONS: This report on TAVR risk assessment within the VA system demonstrates that despite a large proportion of patients classified as prohibitive risk, TAVR was associated with favorable 30-day and 1-year all-cause mortality rates when compared with published outcomes from the STS/ACC TVT registry.

Fractional Flow Reserve Derived from Coronary Computed Tomography Angiography Safely Defers Invasive Coronary Angiography in Patients with Stable Coronary Artery Disease.

OBJECTIVES: In the United States, the real-world feasibility and outcome of using fractional flow reserve from coronary computed tomography angiography (FFRCT) is unknown. We sought to determine whether a strategy that combined coronary computed tomography angiography (CTA) and FFRCT could safely reduce the need for invasive coronary angiography (ICA), as compared to coronary CTA alone. METHODS: The study included 387 consecutive patients with suspected CAD referred for coronary CTA with selective FFRCT and 44 control patients who underwent CTA alone. Lesions with 30-90% diameter stenoses were considered of indeterminate hemodynamic significance and underwent FFRCT. Nadir FFRCT ≤ 0.80 was positive. The rate of patients having ICA, revascularization and major adverse cardiac events were recorded. RESULTS: Using coronary CTA and selective FFRCT, 121 patients (32%) had at least one vessel with ≥50% diameter stenosis; 67/121 (55%) patients had at least one vessel with FFRCT ≤ 0.80; 55/121 (45%) underwent ICA; and 34 were revascularized. The proportion of ICA patients undergoing revascularization was 62% (34 of 55). The number of patients with vessels with 30-50% diameter of stenosis was 90 (23%); 28/90 (31%) patients had at least one vessel with FFRCT ≤ 0.80; 8/90 (9%) underwent ICA; and five were revascularized. In our institutional practice, compared to coronary CTA alone, coronary CTA with selective FFRCT reduced the rates of ICA (45% vs. 80%) for those with obstructive CAD. Using coronary CTA with selective FFRCT, no major adverse cardiac events occurred over a mean follow-up of 440 days. CONCLUSION: FFRCT safely deferred ICA in patients with CAD of indeterminate hemodynamic significance. A high proportion of those who underwent ICA were revascularized.

Technical success and long-term outcomes after anomalous right coronary artery stenting with cardiac computed tomography angiography correlation.

INTRODUCTION: Anomalous origin of coronary arteries has been observed in about 0.35-2.10% of the population. Patients with anomalous right coronary artery (ARCA) may present with significant symptoms, arrhythmias or ACS, and at times sudden death. Traditionally, surgical correction has been the recommended treatment. However, these may be technically challenging, and bypass grafting for such anomalies has the potential for graft failure because of competitive flow. We sought to determine the intermediate and long-term outcomes of drug-eluting stent placement for patients with symptomatic ARCA. We also looked at angiographic findings suggestive of interarterial course as confirmed by subsequent computed tomography (CT) findings. METHODS: Between January 2005 and December 2012, we enrolled 11 patients for elective percutaneous coronary intervention (PCI) of ARCA in a single center, prospective, nonrandomized fashion. Patients were followed up in clinic at 1 week, 3 months, 6 months, and 1 year, and then annually or more frequently if needed. All patients underwent a cardiac CT, as well as functional stress testing when needed to assess for recurrence of disease. RESULTS: All 11 of our patients, who presented with significant symptomatic stenosis with an ARCA, were successfully treated with PCI. Mean follow-up duration was 8.5 years. The only two deaths during follow-up were related to noncardiac causes (sepsis), with a mortality rate of 18.2%. Two patients had a positive functional study and on subsequent coronary angiography, one of them had significant in-stent restenosis (target lesion revascularization of 9.1%) and one distal to the stent (target vessel revascularization 9.1%). We found the observation of a "slit-like lesion" on angiography to have a sensitivity of 100% and specificity of 86% for the diagnosis of interarterial course of the anomalous vessel seen on subsequent CT. CONCLUSIONS: Our study results suggest that PCI of ARCA is an effective and low-risk alternative to surgical correction, with good procedural success and long-term outcomes. It can provide symptomatic relief in such patients and may reduce the risk of sudden death in younger patients, without the inherent risks associated with surgical repair.

Thyrotoxicosis-induced cardiomyopathy treated with venoarterial extracorporeal membrane oxygenation.

A 37-year-old woman with no past medical history presented with longstanding untreated hyperthyroidism and consequentially developed thyrotoxicosis-induced cardiomyopathy. Upon admission, she was noted with a heart rate of 172 beats per minute and an EKG consistent with supraventricular tachycardia which was unresponsive to adenosine. Shortly after the initiation of a non-cardioselective beta-blocker for the treatment of persistent tachycardia, she developed profound cardiogenic shock refractory to vasopressors and inotropes. She was diagnosed with thyroid storm, which was ultimately attributed to Graves' Disease and controlled with propylthiouracil, potassium iodide drops, and hydrocortisone. Extracorporeal membrane oxygenation (ECMO) was successfully used as a temporizing measure while her thyroid hormone level normalized and cardiac function recovered. Patients with longstanding untreated hyperthyroidism may be dependent on the induced hyperadrenergic state to compensate for low-output cardiac failure, therefore it is important to exercise caution when initiating beta-adrenergic blockade. Given the expected disease time-course in cases of acute decompensation, ECMO remains a viable option for short-term mechanical circulatory support.

Pulmonary embolism response team implementation improves awareness and education among the house staff and faculty.

A subset of high-risk pulmonary embolism (PE) patients requires advanced therapy beyond anticoagulation. Significant variation in delivery of care has led institutions to standardize their approach by developing Pulmonary Embolism Response Team (PERT). We sought to assess the impact of PERT implementation on house staff and faculty education. After implementation of PERT, we employed a targeted educational intervention aimed to improve PERT awareness, familiarity with treatment options, role of echocardiogram and Doppler ultrasound, and knowledge of acute PE risk stratification tools. We conducted an anonymous survey among the house staff and faculty before and after intervention to assess the impact of PERT implementation on educational objectives among clinicians. Initial and follow up samples included 115 and 109 responses. The samples were well represented across the subspecialties and all levels of training, as well as junior and senior faculty. Following the educational campaign, awareness of the program increased (72.2-92.6%, p < 0.01). Proportion of clinicians with reported comfort level of managing PE increased (82.4-90.8%, p = 0.07). Proportion of clinicians with self-reported comfort with explaining all available treatment modalities to patients increased (49.1-67.9%, p = 0.005). Proportions of responders who correctly identified the role of echocardiography in risk stratification of patients with known PE increased (73.9-84.4%, p = 0.07). Accurate clinical risk stratification of acute PE increased (60.2-73.8%, p = 0.03). The implementation of a targeted educational program at a tertiary care center increased awareness of PERT among house staff and faculty and improved physician's accuracy of clinical risk stratification and comfort level with management of acute PE.

Contemporary trends in the management of aortic stenosis in the USA.

AIMS: To assess the contemporary trends in aortic stenosis (AS) interventions in the USA before and after the introduction of transcatheter aortic valve implantation (TAVI). METHODS AND RESULTS: We utilized the National-Inpatient-Sample to assess temporal trends in the incidence, cost, and outcomes of AS interventions between 1 January 2003 and 31 December 2016. During the study's period, AS interventions increased from 96 to 137 per 100 000 individuals > 60 years old, P < 0.001. In-hospital expenditure on AS interventions increased from $2.28 billion in 2003 to $4.33 in 2016 P < 0.001. Among patients who underwent aortic valve replacement, the proportion of TAVI increased from 11.9% in 2012 to 43.2% in 2016 (P < 0.001). Males and Hispanics had lower proportions of TAVI compared with females and White patients. Adjusted in-hospital mortality of isolated SAVR decreased from 5.4% in 2003 to 3.3% in 2016 (P < 0.001), whereas adjusted in-hospital mortality of TAVI decreased from 4.7% in 2012 to 2.2% in 2016, P < 0.001. The incidence of new dialysis, permanent pacemaker implantation, and blood transfusion decreased after both TAVI and SAVR between 2012 and 2016. However, the rate of post-operative stroke did not significantly decrease. Length of stay and cost of hospitalization decreased after both SAVR and TAVI, although the later remained higher with TAVI. Rates of non-home discharge decreased over time after TAVI but remained stable after isolated SAVR. CONCLUSION: This nationwide survey documents the increasing incidence of AS interventions, the rising cost of modern AS care, and the paradigm shift in aortic valve replacement practice in the USA.

Right Ventricular Outflow Doppler Predicts Low Cardiac Index in Intermediate Risk Pulmonary Embolism.

Intermediate-risk pulmonary embolism (PE) has variable outcomes. Current risk stratification models lack the positive predictive value to identify patients at highest risk of PE-related mortality. We identified intermediate-risk PE patients who underwent catheter-based interventions and right heart catheterization (RHC) and identified those with low cardiac index (CI < 2.2 L/min/m2). We utilized regression models to identify echocardiographic predictors of low CI and Kaplan Meier curve to evaluate PE-related mortality when stratified by the echocardiographic predictor. Of 174 intermediate-risk PE patients, 41 underwent RHC. Within this cohort, 46.3% had low CI. Univariable linear regression identified right ventricular outflow tract velocity time integral (RVOT VTI), right/left ventricular ratio, S prime, inferior vena cava diameter, and pulmonary artery systolic pressure as potential predictors of low CI. Multivariable linear regression identified RVOT VTI as significant predictor of low CI (ß coefficient 0.124, 95% confidence interval [CI]: 0.01-0.24, P = .034). Right ventricular outflow tract velocity time integral <9.5 cm was associated with increased PE-related mortality, P = .002. A substantial proportion of intermediate-risk PE patients referred for catheter-based interventions had low CI despite normotension. Right ventricular outflow tract velocity time integral was a significant predictor of low CI. Low RVOT VTI was associated with increased PE-related mortality.

Outcomes of Veterans Undergoing TAVR Within Veterans Affairs Medical Centers: Insights From the Veterans Affairs Clinical Assessment, Reporting, and Tracking Program.

OBJECTIVES: This study sought to describe clinical and procedural characteristics of veterans undergoing transcatheter aortic valve replacement (TAVR) within U.S. Department of Veterans Affairs (VA) centers and to examine their association with short- and long-term mortality, length of stay (LOS), and rehospitalization within 30 days. BACKGROUND: Veterans with severe aortic stenosis frequently undergo TAVR at VA medical centers. METHODS: Consecutive veterans undergoing TAVR between 2012 and 2017 were included. Patient and procedural characteristics were obtained from the VA Clinical Assessment, Reporting, and Tracking system. The primary outcomes were 30-day and 1-year survival, LOS >6 days, and rehospitalization within 30 days. Logistic regression and Cox proportional hazards analyses were performed to evaluate the associations between pre-procedural characteristics and LOS and rehospitalization. RESULTS: Nine hundred fifty-nine veterans underwent TAVR at 8 VA centers during the study period, 860 (90%) by transfemoral access, 50 (5%) transapical, 36 (3.8%) transaxillary, and 3 (0.3%) transaortic. Men predominated (939 of 959 [98%]), with an average age of 78.1 years. There were 28 deaths within 30 days (2.9%) and 134 at 1 year (14.0%). Median LOS was 5 days, and 141 veterans were rehospitalized within 30 days (14.7%). Nonfemoral access (odds ratio: 1.74; 95% confidence interval [CI]: 1.10 to 2.74), heart failure (odds ratio: 2.51; 95% CI: 1.83 to 3.44), and atrial fibrillation (odds ratio: 1.40; 95% CI: 1.01 to 1.95) were associated with increased LOS. Atrial fibrillation was associated with 30-day rehospitalization (hazard ratio: 1.79; 95% CI: 1.22 to 2.63). CONCLUSIONS: Veterans undergoing TAVR at VA centers are predominantly elderly men with significant comorbidities. Clinical outcomes of mortality and rehospitalization at 30 days and 1-year mortality compare favorably with benchmark outcome data outside the VA.

Radial Versus Femoral Approach in Women Undergoing Coronary Angiography: A Meta-Analysis of Randomized Controlled Trials.

OBJECTIVES: We sought to compare outcomes with radial vs femoral approach in female patients undergoing coronary angiography. BACKGROUND: Women undergoing cardiac procedures have increased risk of bleeding and vascular complications, but are under-represented in randomized clinical trials (RCTs) involving coronary angiography. METHODS: We performed a meta-analysis of RCTs comparing outcomes in women undergoing angiography with radial vs femoral approaches. The primary outcome was non-coronary artery bypass graft (CABG) related bleeding at 30 days. Secondary outcomes included major adverse cardiovascular or cerebrovascular events (MACCE; a composite of death, stroke or myocardial infarction), vascular complications, procedure duration, and access-site crossover. RESULTS: Four studies (n = 6041 female patients) met the inclusion criteria. In female patients undergoing coronary angiography, radial access decreased non-CABG related bleeding (odds ratio [OR], 0.56; 95% confidence interval [CI], 0.44-0.72; P<.001), MACCE (OR, 0.73; 95% CI, 0.58-0.93; P=.01), vascular complications (OR, 0.49; 95% CI, 0.32-0.75; P<.001) with no significant difference in procedure time (mean difference, 0.04; 95% CI, -0.97 to 0.89; P=.93). There was an increase in access-site crossover using the radial approach (OR, 2.86; 95% CI, 2.24-3.63; P<.001). Patients undergoing radial approach were more likely to prefer radial access for the next procedure (OR, 6.96; 95% CI, 5.70-8.50; P<.001). CONCLUSIONS: In female patients undergoing coronary angiography or intervention, the radial approach is associated with decreased bleeding, MACCE, and vascular complications. These data suggest that radial access should be the preferred approach for women.

Impact of Emergency Medical Services Activation of the Cardiac Catheterization Laboratory and a 24-Hour/Day In-Hospital Interventional Cardiology Team on Treatment Times (Door to Balloon and Medical Contact to Balloon) for ST-Elevation Myocardial Infarction.

The incremental benefit of emergency medical services (EMS) activation of the cardiac catheterization laboratory (CCL) for ST-elevation myocardial infarction (STEMI) in the setting of an established in-house interventional team (IHIT) is uncertain. We evaluated the impact of EMS activation on door-to-balloon (D2B) time and first medical contact-to-balloon (FMC2B) time for STEMI when coupled with a 24-hour/day IHIT. All patients presenting with STEMI to Loyola University Medical Center had demographic, procedural, and outcome data consecutively entered in a STEMI Data Registry. From 223 consecutive patients presenting between April 2009 and December 2015, a retrospective analysis was performed on 190 patients. Patients were divided into 2 groups depending on CCL activation mode (EMS activation or emergency department activation) and STEMI treatment process times were compared. The primary end point was D2B process times. The secondary end point was FMC2B process times in a subgroup analysis of EMS-transported patients. D2B times were shorter (37 ± 14 minutes vs 57 ± 27 minutes, p < 0.001) with EMS activation. Subgroup analysis of EMS-transported patients demonstrated shorter FMC2B times with EMS activation (52 ± 17 minutes vs 67 ± 32 minutes, p = 0.002). EMS activation was the only predictor of D2B ≤60 minutes in multivariable analysis of EMS-transported patients (odds ratio 9.4; 95% confidence interval 2.1 to 43.0; p = 0.04). In conclusion, EMS activation of the CCL in STEMI was associated with significant improvements in already excellent D2B and FMC2B times even in the setting of a 24-hour/day IHIT.