Catheter based interventions for lower extremity peripheral artery disease.

The field of peripheral arterial intervention has exploded over the past 20 years. Current knowledge includes a growing evidence base for treatment as well as a myriad of new interventional approaches to complex disease. This review seeks to outline the current state of the art for interventional approaches to lower extremity peripheral arterial disease.

Understanding Quality Paradigm Shifts in the Evolving Pharmaceutical Landscape: Perspectives from the USP Quality Advisory Group.

Recent changes in the pharmaceutical industry have led to significant paradigm shifts in the pharmaceutical quality environment. Globalization of the pharmaceutical industry, increasingly rapid development of novel therapies, and adoption of new manufacturing techniques have presented numerous challenges for the established regulatory framework and quality environment and are impacting the approaches utilized to ensure the quality of pharmaceutical products. Regulators, industry, and standards-setting organizations have begun to recognize the need to rely more on integrated risk-based approaches and to create more nimble and flexible standards to complement these efforts. They also increasingly have recognized that quality needs to be built into systems and processes throughout the lifecycle of the product. Moreover, the recent COVID-19 crisis has emphasized the need to adopt practices that better promote global supply chain resilience. In this paper, the USP Quality Advisory Group explores the various paradigm shifts currently impacting pharmaceutical quality and the approaches that are being taken to adapt to this new environment. Broad adoption of the Analytical Procedure Lifecycle approach, improved data management, and utilization of digital technologies are identified as potential solutions that can help meet the challenges of these quality paradigm shifts. Further discussion and collaboration among stakeholders are needed to pursue these and other solutions that can ensure a continued focus on quality while facilitating pharmaceutical innovation and development.

CYP2C19 pharmacogenetics in patients undergoing coronary stent placement: Is it time to test everyone?

Although there are no current guidelines for when to test patients for CYP2C19 loss of function alleles, the current state of evidence suggests that testing high-risk patients should be considered. Based on this meta-analysis, there is no reduction in major adverse cardiovascular events (MACE) in patients that receive genotype-guided antiplatelet therapy, but there is a significant reduction in MACE when including only patients who present with acute coronary syndromes and a significant reduction in myocardial infarction. Genotype-guided therapy shows promise but requires further study to solidify this approach, and to determine which patients derive the most benefit.

STEMIs and Coumadin: Are they an unsafe combination?

Therapeutic anticoagulation may be a surrogate marker for increased MACE in the setting of a STEMI. Consideration should be given to transradial access for patients on anticoagulation. Triple therapy (DAPT plus anticoagulant) should be minimized.

Radiation safety with dose reduction technology: The buck stops at zero dose.

Exposure to ionizing radiation in cardiovascular imaging and its adverse impact on health is a growing concern. Cath lab imaging dose-reduction technology is an effective way to reduce patient and operator radiation dose. More clinical trials and studies such as this one are needed to assess the short-and long-term impact of this important technology.

SYNTAX II in the "real world" - A practical approach to coronary risk-stratification.

The SYNTAX II score is valid in the real world, and can be applied to international patient cohorts It is an independent predictor of overall mortality and other cardiovascular endpoints It is a practical tool for coronary risk stratification given its inclusion of pertinent clinical data in addition to anatomic data.

Infrapopliteal peripheral arterial disease and critical limb ischemia: The time has come for collaborative, streamlined diagnostic, and treatment paradigms.

The diagnosis, surveillance, and management of infrapopliteal critical limb ischemia remain inconsistent among clinicians. This study demonstrates that using an absolute ankle pressure of >73 mm Hg or an absolute toe pressure increase of 1 mm Hg or greater post endovascular intervention in patients with infrapopliteal critical limb ischemia may be predictive of a reduction in target limb revascularization, amputation, and death. This study highlights the need for vascular societies to come together to promote standardized screening, surveillance, and treatment paradigms for this complex population.

Re-Evaluating the Safety of Drug-Eluting Stents in Cancer Patients.

Evidence increasingly shows that cancer and coronary artery disease are interlinked through common risk factors, co-occurrence in an aging population, and through the deleterious effects of cancer treatment on cardiovascular health. Many of the clinical risk factors for cancer, such as diabetes, smoking, and chronic inflammatory state, are also risk factors for coronary artery disease and for stent restenosis and thrombosis. The current generations of drug-eluting stents have been proven to reduce the risk of restenosis and stent thrombosis as compared with bare-metal stents. However, because of the perceived need for shorter course of dual antiplatelet treatment, operators often prefer bare-metal stents in patients with cancer out of concern for increased bleeding risk and expectant need for cancer-directed surgery. The current evidence with newer-generation stent technology demonstrates the feasibility of shorter duration of dual antiplatelet treatment, without increasing the risk of stent thrombosis and bleeding, while maintaining improved efficacy compared with bare-metal stents. Cardiovascular disease in patients with cancer is complex, and treatment needs to be individualized. Refraining from the use of drug-eluting stents altogether in this rapidly expanding cohort may lead to higher major adverse cardiovascular events, which can thwart the effectiveness of advances in both cancer and cardiovascular therapeutics. Considering the developing evidence thus far, perhaps it is time to rethink the choice of stent in patients with cancer who undergo percutaneous coronary intervention.

Intracranial hemorrhage in a patient with sub-massive pulmonary embolism treated with EkoSonic endovascular system directed thrombolysis.

Ultrasound-assisted catheter-directed thrombolysis therapy has emerged more recently as a management strategy for patients with intermediate risk pulmonary embolism and has shown promising results in clinical trials by early reversal of right ventricle dilation, reduced pulmonary hypertension, and decreased anatomic thrombus burden. This therapeutic strategy requires a small fraction of the systemic fibrinolytic dose and is therefore associated with a reduced bleeding risk. Although intracranial hemorrhage has not been reported in clinical trials, it is a possible complication. Here we report the first case of intracranial hemorrhage related to the use of EkoSonic™ Endovascular System directed thrombolysis in a patient with large bilateral pulmonary embolism without any identifiable bleeding risks. © 2017 Wiley Periodicals, Inc.

Radial Artery Catheterization: Which is Right I Mean Correct?

The radial artery has gained favor as the access of choice for many operators due to a lower risk of vascular complications. The vascular anatomy of the left upper extremity may be more conducive to cardiac catheterization given reduced subclavian tortuosity. The left radial artery continues to be an arrow in the quiver of modern interventional cardiologist and may provide less radiation exposure when compared to the right radial artery.

In multivessel coronary artery disease, a "state-of-the-art" randomized clinical trial of revascularization is needed.

Based on this meta-analysis of primarily observational data, complete revascularization (CR) is associated with a reduced risk of death, MI, and repeat revascularization in patients with multivessel coronary artery disease (MVCAD) as compared with incomplete revascularization (IR). Given the current state of evidence, the likelihood of achieving complete revascularization should influence whether PCI or CABG is the best strategy in patients with MVCAD. Given the lack of randomized trials in this area, more robust trial data will address the validity of these findings.

Duration of dual anti-platelet therapy following drug eluting stents: Less Is More?

This meta-analysis suggests that abbreviated DAPT (<6 months) could be considered in patients undergoing PCI with current generation drug eluting stents (DES). Extended DAPT strategy (>1 year) may be appropriate in those patients in whom prevention of stent and non-stent-related coronary events are likely to offset the bleeding complications. Additional randomized trials are needed to evaluate the optimum duration of DAPT in patients with the latest generation DES and current antiplatelet drugs.