Incorporating economic analysis in interventional cardiology research.

Evaluative research in interventional cardiology has focused on clinical and technical outcomes. Inclusion of economic data can enhance evaluative research by quantifying the relative economic burden incurred by different therapies. When combined with clinical outcomes, cost data can provide a measure of value (e.

Stent-Based Gene Delivery for Coronary Disease.

Percutaneous coronary interventions (PCI) are the mainstay for treatment of advanced coronary disease. A majority of PCI involve deployment of a stent in the affected vascular segment. This chapter introduces the concept of using stents as a platform for delivering gene therapies to the vasculature with the overarching aim of mitigating in-stent restenosis (ISR), late stent thrombosis (LST), and neoatherosclerosis (NA), a triad of delayed complications that reduce the overall success rate of PCI.

Hypertension urgencies in the SPYRAL HTN-OFF MED Pivotal trial.

The SPYRAL HTN-OFF MED Pivotal trial ( https://clinicaltrials.gov/ct2/show/NCT02439749 ) demonstrated significant reductions in blood pressure (BP) after renal denervation (RDN) compared to sham control in the absence of anti-hypertensive medications. Prior to the 3-month primary endpoint, medications were immediately reinstated for patients who met escape criteria defined as office systolic BP (SBP) ≥ 180 mmHg or other safety concerns.

Stent-based delivery of AAV2 vectors encoding oxidation-resistant apoA1.

In-stent restenosis (ISR) complicates revascularization in the coronary and peripheral arteries. Apolipoprotein A1 (apoA1), the principal protein component of HDL possesses inherent anti-atherosclerotic and anti-restenotic properties. These beneficial traits are lost when wild type apoA1(WT) is subjected to oxidative modifications.

Robust quantitative assessment of collagen fibers with picrosirius red stain and linearly polarized light as demonstrated on atherosclerotic plaque samples.

Collagen is an important component in maintaining structural integrity and functionality of tissues and is modulated in various biological processes. Its visualization and possible quantification using histopathological stains can be important for understanding disease progression or therapeutic response. Visualization of collagen fiber with the histological stain picrosirius red (PSR) is enhanced with polarized light and quantitative analysis is possible using circular polarizers.

Efficacy of catheter-based renal denervation in the absence of antihypertensive medications (SPYRAL HTN-OFF MED Pivotal): a multicentre, randomised, sham-controlled trial.

Background: Catheter-based renal denervation has significantly reduced blood pressure in previous studies. Following a positive pilot trial, the SPYRAL HTN-OFF MED (SPYRAL Pivotal) trial was designed to assess the efficacy of renal denervation in the absence of antihypertensive medications.

Methods: In this international, prospective, single-blinded, sham-controlled trial, done at 44 study sites in Australia, Austria, Canada, Germany, Greece, Ireland, Japan, the UK, and the USA, hypertensive patients with office systolic blood pressure of 150 mm Hg to less than 180 mm Hg were randomly assigned 1:1 to either a renal denervation or sham procedure.

Impact Of Cirrhosis On 90-Day Outcomes After Percutaneous Coronary Intervention (from A Nationwide Database).

Patients with cirrhosis often have concomitant coronary artery disease and require percutaneous coronary intervention (PCI). PCI in cirrhotics can be associated with significant risks due to thrombocytopenia, possible coagulopathies, bleeding, and renal failure. Longer term risks of PCI in cirrhotics have not been well studied.

One-Year Outcomes of Percutaneous Coronary Intervention in Patients with End-Stage Liver Disease.

Background: Patients with cirrhosis and coronary artery disease (CAD) are at high risk for morbidity during surgical revascularization so they are often referred for complex percutaneous coronary intervention (PCI). Percutaneous coronary intervention in the cirrhotic population also has inherent risks; however, quantifiable data on long-term outcomes are lacking.

Methods: Patients with angiographically significant CAD and cirrhosis were identified from the catheterization lab databases of the University of Pennsylvania Health System between 2007 and 2015.

Prospective Genotyping to Guide Antiplatelet Therapy Following Percutaneous Coronary Intervention: A Pragmatic Randomized Clinical Trial.

Background: loss-of-function alleles impair clopidogrel effectiveness after percutaneous coronary intervention, but the clinical impact of implementing genotyping in a real-world setting is unknown. The purpose of the study was to determine whether returning genotype results along with genotype-guided pharmacotherapy recommendations using a rapid turnaround test would change antiplatelet prescribing following percutaneous coronary intervention.The primary outcome was the rate of prasugrel or ticagrelor prescribing in each arm.

Catheter-based renal denervation in patients with uncontrolled hypertension in the absence of antihypertensive medications (SPYRAL HTN-OFF MED): a randomised, sham-controlled, proof-of-concept trial.

Background: Previous randomised renal denervation studies did not show consistent efficacy in reducing blood pressure. The objective of our study was to evaluate the effect of renal denervation on blood pressure in the absence of antihypertensive medications.

Methods: SPYRAL HTN-OFF MED was a multicentre, international, single-blind, randomised, sham-controlled, proof-of-concept trial.

Comparative Outcomes After Percutaneous Coronary Intervention Among Black and White Patients Treated at US Veterans Affairs Hospitals.

Importance: Current comparative outcomes among black and white patients treated with percutaneous coronary intervention (PCI) in the Veterans Affairs (VA) health system are not known.

Objective: To compare outcomes between black and white patients undergoing PCI in the VA health system.

Design, Setting, And Participants: This study compared black and white patients who underwent PCI between October 1, 2007, and September 30, 2013, at 63 VA hospitals using data recorded in the VA Clinical Assessment, Reporting, and Tracking System for Cardiac Catheterization Laboratories (CART-CL) program.

Robotic-assisted percutaneous coronary intervention.

Performance of percutaneous coronary intervention (PCI) is associated with several occupational hazards including radiation exposure and musculoskeletal injury. Current methods to mitigate these risks range from suspended radiation suits to adjustable lead-lined glass shields. Robotic-assisted PCI is a novel approach to PCI that utilizes remote-controlled technology to manipulate catheters thereby significantly reducing radiation exposure to the operator and catheterization laboratory staff.

Text mining applied to electronic cardiovascular procedure reports to identify patients with trileaflet aortic stenosis and coronary artery disease.

Background: Interrogation of the electronic health record (EHR) using billing codes as a surrogate for diagnoses of interest has been widely used for clinical research. However, the accuracy of this methodology is variable, as it reflects billing codes rather than severity of disease, and depends on the disease and the accuracy of the coding practitioner. Systematic application of text mining to the EHR has had variable success for the detection of cardiovascular phenotypes.

Retinal pathology is associated with increased blood-retina barrier permeability in a diabetic and hypercholesterolaemic pig model: Beneficial effects of the LpPLA inhibitor Darapladib.

Using a porcine model of diabetes mellitus and hypercholesterolaemia, we previously showed that diabetes mellitus and hypercholesterolaemia is associated with a chronic increase in blood-brain barrier permeability in the cerebral cortex, leading to selective binding of immunoglobulin G and deposition of amyloid-beta peptide in pyramidal neurons. Treatment with Darapladib (GlaxoSmithKline, SB480848), an inhibitor of lipoprotein-associated phospholipase-A2, alleviated these effects. Here, investigation of the effects of chronic diabetes mellitus and hypercholesterolaemia on the pig retina revealed a corresponding increased permeability of the blood-retina barrier coupled with a leak of plasma components into the retina, alterations in retinal architecture, selective IgG binding to neurons in the ganglion cell layer, thinning of retinal layers due to cell loss and increased glial fibrillary acidic protein expression in Müller cells, all of which were curtailed by treatment with Darapladib.

Bioresorbable Scaffolds for Coronary Artery Disease.

Purpose Of Review: The purpose of this review is to present an overview of the recent evidence regarding the use of bioresorbable scaffolds in percutaneous coronary intervention.

Recent Findings: Bioresorbable scaffolds represent a potentially unique engineering solution to the problems associated with metallic stents. The Absorb everolimus-eluting bioresorbable scaffold has been the most extensively tested of this class and is currently Food and Drug Administration-approved for use in the USA.

Is multivessel intervention in ST-elevation myocardial infarction associated with early harm? Insights from observational data.

Objectives: Appraisal of evidence for recommendations for multivessel coronary intervention in ST-elevation myocardial infarction (STEMI).

Background: Multi-vessel disease (MVD) is common in patients with ST-segment elevation myocardial infarction (STEMI). Published observational data has suggested that multi-vessel percutaneous coronary intervention (MVPCI) at the time of initial hospitalization for STEMI may be harmful in contrast to evidence from recent randomized trials.

The vulnerable artery: early and rapid deposition of lipid in coronary arteries is associated with subsequent development of thin-cap fibroatheromas.

Aims: We aimed to determine whether intravascular ultrasound (IVUS) and near infrared spectroscopy (NIRS) could identify arteries which would subsequently develop a thin-cap fibroatheroma (TCFA).

Methods And Results: Three-vessel angiography, IVUS and NIRS evaluations were performed at three, six and nine months after induction of diabetes mellitus and hypercholesterolaemia in 13 Yorkshire pigs (n=37 arteries). In vivo total arterial plaque plus media (P+M) area, echo-attenuated plaque (AP) area by IVUS, and lipid core burden index (LCBI) by NIRS were compared to histology at nine months.

Sex Differences in Outcomes Following Percutaneous Coronary Intervention According to Age.

Background: Women <50 years of age with coronary artery disease may represent a group at higher risk for recurrent ischemic events after percutaneous coronary intervention (PCI); however, no long-term, multicenter outcomes assessment exists in this population.

Methods And Results: Using the National Heart, Lung, and Blood Institute Dynamic Registry, we evaluated the association of sex and age on cardiovascular-related outcomes in 10,963 patients (3797 women, 394 <50 years) undergoing PCI and followed for 5 years. Death, myocardial infarction, coronary artery bypass graft surgery, and repeat PCI were primary outcomes comprising major adverse cardiovascular events.

Transradial Versus Transfemoral Access in Patients Undergoing Rescue Percutaneous Coronary Intervention After Fibrinolytic Therapy.

Objectives: The purpose of this study was to assess usage patterns of transradial access in rescue percutaneous coronary intervention (PCI) for ST-segment elevation myocardial infarction (STEMI) and associations between vascular access site choice and outcomes.

Background: Transradial access reduces bleeding and mortality in STEMI patients undergoing primary PCI. Little is known about access site choice and outcomes in patients undergoing rescue PCI after receiving full-dose fibrinolytic therapy for STEMI.

Phase I study of multi-gene cell therapy in patients with peripheral artery disease.

Unlabelled: Alternative treatment strategies for claudication are needed and cell-based therapies designed to induce angiogenesis are promising. The purpose of this report was to conduct a Phase I safety, dose-escalating, non-randomized, open-label study of autologous, fully differentiated venous endothelial and smooth muscle cells called MultiGeneAngio (MGA) for claudication due to peripheral artery disease. Twelve subjects, at two centers, received a single intra-arterial infusion of a suspension of equal amounts of transduced autologous venous smooth muscle cells expressing vascular endothelial growth factor (VEGF165) and endothelial cells expressing angiopoietin-1 (Ang-1) (Cohort 1: 1 × 10(7), Cohort 2: 2 × 10(7), Cohort 3: 5 × 10(7), Cohort 4: 7 × 10(7)).