Overcoming Barriers to Developing and Implementing Novel Therapies for Hypertension.

Hypertension is the single most important modifiable risk factor for preventable disability and death worldwide and disproportionately affects socially disadvantaged populations. We face a paradox-blood pressure control is low and recent trends suggest it is even declining, despite the availability of inexpensive and effective therapies. A variety of barriers on the system, patient, and healthcare provider side hinder effective drug-based risk factor management.

FFRangio-guided versus pressure wire-guided PCI: design and rationale of the multicentre, randomised ALL-RISE trial.

Wire-based indices of coronary physiology are the gold standard for guiding revascularisation decisions in patients with coronary artery disease and angiographically intermediate coronary stenoses. FFRangio is a novel angiography-based technology for assessing the functional significance of epicardial coronary stenoses without pressure wires or hyperaemic stimulus. The primary objective of the Advancing Cath Lab Results with FFRangio Coronary Physiology Assessment trial (ALL-RISE; ClinicalTrials.

Paclitaxel-Coated Balloon for the Treatment of Multilayer In-Stent Restenosis: AGENT IDE Subgroup Analysis.

Background: Patients with coronary in-stent restenosis (ISR) within multiple layers of stent pose a specific clinical challenge because of higher rates of recurrent restenosis as well as a desire to avoid an additional layer of stent. Drug-coated balloons (DCBs) provide an alternative antiproliferative therapeutic option for multilayer ISR.

Objectives: We evaluated the efficacy and safety of a low-dose paclitaxel-coated vs uncoated balloon among patients with multilayer or single-layer ISR in the AGENT IDE (A Clinical Trial to Assess the Agent Paclitaxel Coated PTCA Balloon Catheter for the Treatment of Subjects With In-Stent Restenosis) trial.

Radial Approach Renal Denervation: A First-in-Man Case With the 4-F TIVUS Catheter.

Background: Renal denervation (RDN) is an effective procedure for the treatment of uncontrolled hypertension, typically performed via the femoral approach. Although RDN is generally safe, vascular complications remain the most frequent adverse events.

Case Summary: A 57-year-old man with resistant hypertension was enrolled in the Renal Denervation Using Ultrasonic Catheter EmitteD Energy Study (REDUCED 1) clinical study.

Cost-Utility Analysis of Endovascular Ultrasound Renal Denervation to Treat Resistant Hypertension in the United States.

Background: This study evaluated the cost utility of ultrasound renal denervation (uRDN) for resistant hypertension in the United States.

Methods: A previously published Markov model was adapted to compare total costs and quality-adjusted life years (QALY) between uRDN plus standard of care (SoC) vs SoC alone over a lifetime horizon from a US health care system perspective. Patient characteristics and clinical inputs were drawn from the RADIANCE-HTN TRIO trial, and the incidence of key cardiovascular events was estimated using published risk equations.

Institutional Variability in Processes of Care and Outcomes Among Patients With STEMI in the US.

Importance: Percutaneous coronary intervention (PCI) is the criterion standard for acute ST-elevation myocardial infarction (STEMI). Achieving target first medical contact (FMC)-to-device time is a quality metric in STEMI care.

Objectives: To describe site-level variability in achieving target FMC-to-device time (≤90 minutes for primary presentations to PCI-capable hospitals and ≤120 minutes for transfers), compare treatment times according to hospital performance, location, and primary PCI volume, and assess whether these aspects are associated with clinical outcomes.

Real-World Evaluation of PCI Guidance Using Dynamic Coronary Roadmap: A DCR4Contrast Trial Secondary Analysis.

Background: Iodinated contrast used during percutaneous coronary intervention (PCI) risks contrast-induced acute kidney injury (CI-AKI). Reducing this risk is essential as PCI procedures become more complex. Dynamic Coronary Roadmap (DCR) is a PCI tool that overlays a virtual roadmap on fluoroscopy and has been shown to reduce contrast use.

Cost-Effectiveness of Ultrasound Renal Denervation for Resistant Hypertension in Belgium, France and The Netherlands.

Background: Endovascular ultrasound renal denervation (uRDN) with the Paradise System has emerged as an adjunctive treatment option for the management of uncontrolled resistant hypertension (rHTN). This study assesses the cost-effectiveness of uRDN for rHTN across three European countries-Belgium, France and the Netherlands.

Methods: On the basis of a previously developed state-transition Markov model, we projected costs, life years (LYs) and quality adjusted life years (QALYs) with the addition of uRDN to standard of care (SoC) compared with SoC alone over patient lifetime.

The Impact of Intravascular Ultrasound Use on 1-Year Outcomes After Infrapopliteal Endovascular Intervention.

Background: Data supporting the use of intravascular ultrasound (IVUS) in aortoiliac and femoropopliteal endovascular intervention are becoming increasingly robust, but data in the infrapopliteal circulation remain limited. The aim of this study was to evaluate the association between IVUS use and 1-year outcomes after infrapopliteal intervention.

Methods: All infrapopliteal endovascular interventions that occurred between 2018-2021 at a single academic medical center were retrospectively reviewed.

Diagnosis and Management of Post-PCI Left Circumflex Coronary Artery Pseudoaneurysm.

Background: Coronary artery pseudoaneurysms (PSAs) are a rare but potentially life-threatening complication after percutaneous coronary intervention (PCI), typically manifesting between 1 week and 4 years after the procedure. Prompt diagnosis is crucial, particularly in high-risk PSAs, which incur potential for rupture.

Case Summary: The authors report the case of a 77-year-old man in whom a large PSA developed in the left circumflex artery within 30 days of PCI, which was complicated by coronary perforation.

Orbital atherectomy versus balloon angioplasty before drug-eluting stent implantation in severely calcified lesions eligible for both treatment strategies (ECLIPSE): a multicentre, open-label, randomised trial.

Background: Coronary artery calcification is common among patients undergoing percutaneous coronary intervention (PCI), and severe coronary artery lesion calcification is associated with increased procedural complexity, stent under-expansion, and high rates of intraprocedural complications and out-of-hospital adverse events. Whether calcium ablation before stent implantation can mitigate these adverse events is not currently established. We aimed to prospectively compare orbital atherectomy with a balloon angioplasty-based strategy before stent implantation for the treatment of severely calcified coronary lesions.

Priorities for medical device regulatory approval: a report from the European Society of Cardiology Cardiovascular Round Table.

The European Union (EU) Medical Device Regulation increased regulatory scrutiny to improve the safety and performance of new medical devices. An equally important goal is providing timely access to innovative devices to benefit patient care. The European Society of Cardiology strongly advocates for the evolution of the Medical Device Regulation system to facilitate priority access for innovative devices for unmet needs and orphan cardiovascular (CV) medical devices in EU countries.

Management of Coronary Stent Underexpansion.

Coronary stent underexpansion is an important problem and limitation of percutaneous coronary intervention, adversely affecting both short- and long-term patient outcomes. Stent underexpansion occurs when a stent fails to expand adequately compared with the adjacent reference segment, resulting in inadequate luminal gain. Multiple studies suggest that stent underexpansion is associated with increased risks of in-stent restenosis, stent thrombosis, and myocardial infarction, resulting in recurrent symptoms, readmissions, repeat interventions, and increased mortality.

Renal denervation for hypertension.

Innovative therapies for hypertension are desperately needed given the rising prevalence and falling rates of control of hypertension despite an abundance of available medical therapies. Procedural interventions lower blood pressure without depending on adherence to medications, and endovascular renal denervation (RDN) is the interventional procedure with the best evidence base for the treatment of hypertension. After nearly two decades of study, with major refinements to devices, technique and trial design, two different systems for RDN received approval from the FDA in late 2023 for the treatment of hypertension.

The efficacy of revascularization in ischemic cardiomyopathy.

Ischemic cardiomyopathy (ICM) is characterized by myocardial dysfunction due to myocardial ischemia, associated with the presence of significant coronary artery disease (CAD). We provide a comprehensive review of the current evidence for coronary revascularization in ICM, including consideration of the different modalities of coronary artery bypass grafting and percutaneous coronary intervention. In addition to a contemporary assessment of the literature, we aim to provide real-world insights and perspectives to guide clinical decision-making in this heterogeneous and complex patient population.

Anticoagulation Among Patients Hospitalized for COVID-19 : A Systematic Review and Prospective Meta-analysis.

Background: Reported results of clinical trials assessing higher-dose anticoagulation in patients hospitalized for COVID-19 have been inconsistent.

Purpose: To estimate the association of higher- versus lower-dose anticoagulation with clinical outcomes.

Data Sources: Randomized trials were identified from the World Health Organization's International Clinical Trials Registry Platform and ClinicalTrials.

Quality of Life Effects of Renal Artery Stenting Versus Medical Therapy for Atherosclerotic Renal-Artery Stenosis: Results from the Randomized CORAL Trial.

Background: Renal-artery stenosis can be associated with difficult to control hypertension, although renal-artery stenting has not been shown to improve clinical outcomes. Alternative antihypertensive medications could potentially result in quality of life benefits with renal-artery stenting.

Methods: We performed a pre-specified quality of life sub-study of the CORAL trial-multicenter, randomized, open-label trial of renal-artery stenting versus medical therapy in patients with atherosclerotic renal-artery stenosis.