Elevated triglycerides and treatment eligibility in patients with severe, asymptomatic carotid stenosis: CREST 2 Trials.

Background: Data from the Centers for Disease Control show that approximately one-quarter of adults have elevated triglyceride (TG) levels. Some clinical trials, but not all, have demonstrated that pharmacologic treatment of high TG levels in patients already on statin therapy reduces the rate of major vascular events such as myocardial infarction and stroke. We assessed the prevalence of elevated TG levels in patients with asymptomatic carotid stenosis (CS), and medical conditions associated with high TG.

Effect of Alcohol-Mediated Renal Denervation on Blood Pressure in the Presence of Antihypertensive Medications: Primary Results From the TARGET BP I Randomized Clinical Trial.

Background: Renal denervation (RDN) has demonstrated clinically relevant reductions in blood pressure (BP) among individuals with uncontrolled hypertension despite lifestyle intervention and medications. The safety and effectiveness of alcohol-mediated RDN have not been formally studied in this indication.

Methods: TARGET BP I is a prospective, international, sham-controlled, randomized, patient- and assessor-blinded trial investigating the safety and efficacy of alcohol-mediated RDN.

Pharmacomechanical Catheter-Directed Thrombolysis With the Bashir Endovascular Catheter for Acute Pulmonary Embolism: The RESCUE Study.

Background: Catheter-directed thrombolysis (CDT) has been associated with rapid recovery of right ventricular (RV) function. The Bashir catheter was developed for enhanced thrombolysis in large vessels such as the pulmonary arteries (PAs) with lower doses of tissue plasminogen activator (tPA).

Objectives: The aim of this study was to evaluate the efficacy and safety of tPA infused using a pharmacomechanical (PM) CDT device called the Bashir endovascular catheter in patients with intermediate-risk acute pulmonary embolism (PE).

Percutaneous Coil Embolization of Coronary Artery Fistula Complicated by Refractory Ventricular Fibrillation and Cardiogenic Shock.

We present a case of a 56-year-old patient with a symptomatic right coronary artery to pulmonary artery fistula who underwent coil embolization. Post-procedure, the patient developed ventricular fibrillation that was refractory to antiarrhythmic medications and numerous attempts at defibrillation. ().

Case Series of Percutaneous Mechanical Aspiration of Mitral Valve Endocarditis.

Infective endocarditis of the mitral valve that is refractory to medical therapy requires surgical debridement. However, patients who are high risk for surgery have limited options. We report 3 cases of refractory infective endocarditis involving the mitral valve that were treated with percutaneous mechanical aspiration with an embolic protection system.

Update on cardiogenic shock: The evolving landscape of a multidisciplinary and collaborative approach.

The American Heart Association scientific statement on cardiogenic shock and the National Cardiogenic Shock Initiative have provided the impetus to advance knowledge and development of national guidelines for cardiogenic shock. We evaluate the current state of knowledge surrounding cardiogenic shock and limitations to the development of national guidelines.

iCAST Balloon-Expandable Covered Stent for Iliac Artery Lesions: 3-Year Results from the iCARUS Multicenter Study.

Purpose: To evaluate safety and effectiveness of the iCAST Covered Stent for treatment of iliac artery atherosclerotic lesions.

Materials And Methods: The iCARUS trial (ClinicalTrials.gov Identifier: NCT00593385) was a single-arm, prospective, multicenter study that enrolled 152 per protocol subjects at 25 sites in the United States and Germany.

Improved Outcomes Associated with the use of Shock Protocols: Updates from the National Cardiogenic Shock Initiative.

Background: The National Cardiogenic Shock Initiative is a single-arm, prospective, multicenter study to assess outcomes associated with early mechanical circulatory support (MCS) in patients presenting with acute myocardial infarction and cardiogenic shock (AMICS) treated with percutaneous coronary intervention (PCI).

Methods: Between July 2016 and February 2019, 35 sites participated and enrolled into the study. All centers agreed to treat patients with AMICS using a standard protocol emphasizing invasive hemodynamic monitoring and rapid initiation of MCS.

The State of the Absorb Bioresorbable Scaffold: Consensus From an Expert Panel.

Significant progress has been made in the percutaneous coronary intervention technique from the days of balloon angioplasty to modern-day metallic drug-eluting stents (DES). Although metallic stents solve a temporary problem of acute recoil following balloon angioplasty, they leave behind a permanent problem implicated in very late events (in addition to neoatherosclerosis). BRS were developed as a potential solution to this permanent problem, but the promise of these devices has been tempered by clinical trials showing increased risk of safety outcomes, both early and late.

Intravascular Ultrasound Validation of Contemporary Angiographic Scores Evaluating the Severity of Calcification in Peripheral Arteries.

Purpose: To validate 3 angiographic scoring systems for peripheral artery calcification using intravascular ultrasound (IVUS) as the gold standard.

Methods: The study employed preprocedure angiography and IVUS data from 47 patients (median age 72 years; 34 men) in the 55-patient JetStream G3 Calcium Study ( ClinicalTrials.gov identifier NCT01273623) to validate the 3 angiographic scoring systems [Peripheral Academic Research Consortium (PARC), Peripheral Arterial Calcium Scoring System (PACSS), and the DEFINITIVE Ca trial].

Intravascular ultrasound evaluation of JETSTREAM atherectomy removal of superficial calcium in peripheral arteries.

Aims: Endovascular treatment of calcified femoral-popliteal disease is challenging. We sought to evaluate the mechanism of lumen gain when using the JETSTREAM Atherectomy System to treat calcified peripheral artery lesions.

Methods And Results: The JETSTREAM Calcium Study was a prospective, single-arm, multicentre study to evaluate the JETSTREAM Atherectomy System for severely calcified femoral-popliteal artery lesions, i.

Carotid artery stenting and patient outcomes: the CABANA surveillance study.

Objectives: The purpose of the prospective, multicenter, nonrandomized CABANA study was to evaluate periprocedural clinical outcomes in high surgical risk patients with carotid artery stenosis treated with the Carotid WALLSTENT plus FilterWire EZ Embolic Protection System by a diverse group of clinicians.

Background: There is a need for additional evidence evaluating carotid artery stenting (CAS) performed by operators with various experience and training levels.

Methods: The study enrolled symptomatic (≥50% carotid artery stenosis) and asymptomatic (≥80% carotid stenosis) patients at high risk for carotid endarterectomy.

Initial clinical results using intracardiac electrogram monitoring to detect and alert patients during coronary plaque rupture and ischemia.

Objectives: We report the first clinical studies of intracardiac ST-segment monitoring in ambulatory humans to alert them to significant ST-segment shifts associated with thrombotic occlusion.

Background: Despite improvements in door-to-balloon times, delays in symptom-to-door times of 2 to 3 h remain. Early alerting of the presence of acute myocardial infarction could prompt patients to seek immediate medical evaluation.

The Angio-Seal Evolution registry: outcomes of a novel automated Angio-Seal vascular closure device.

Objectives: The objective of the study was to assess the efficacy and safety of a novel vascular closure device, the Angio-Seal Evolution (EVCD), in patients undergoing routine cardiac catheterization (CATH) and intervention (PCI) via a retrograde femoral artery access.

Background: Successful use of current-generation vascular closure devices is highly dependent on operator methodology. To reduce dependence on operator technique, the EVCD was modified to automate the closure process, specifically the compaction of the extravascular collagen sponge that creates a sandwich under pressure against the intra-arterial anchor.

Protected carotid stenting in high-risk patients: results of the SpideRX arm of the carotid revascularization with ev3 arterial technology evolution trial.

Purpose: A prospective nonrandomized multicenter registry of 160 patients with severe carotid stenosis and high-risk features for carotid endarterectomy was conducted during the 3-month period from March to May 2005.

Methods: Carotid artery stenting (CAS) was performed with the SpideRX™ Embolic Protection System (ev3, Inc., Plymouth, MN, USA) as part of an investigational device exemption from the Food and Drug Administration.

Carotid artery stenting with emboli protection surveillance study: outcomes at 1 year.

Objectives: The CASES-PMS (Carotid Artery Stenting With Emboli Protection Surveillance-Post-Marketing Study) multicenter, prospective, single-arm, surveillance study was designed to assess the safety and efficacy of carotid artery stenting (CAS) when performed by physicians with varied experience in CAS utilizing a formal training program. Whether the excellent results achieved at 30 days would be sustained to 1 year was the subject of the current investigation.

Background: Previously, the pivotal SAPPHIRE (Stenting and Angioplasty with Protection of Patients with High Risk for Endarterectomy) trial demonstrated that CAS was not inferior to carotid endarterectomy (CEA) when performed by physicians experienced in carotid stenting.

Initial clinical experience using an ostial stent positioning system (Ostial Pro) for the accurate placement of stents in the treatment of coronary aorto-ostial lesions.

Objective: To evaluate the safety and efficacy of a new nitinol stent positioning system to assist in the placement of aorto-ostial coronary stents.

Background: The stenting of aorto-ostial lesions is technically challenging.

Methods: We report the first clinical series using the Ostial Pro to assist in the precise placement of stents in coronary aorto-ostial lesions.

Protected carotid stenting in high-risk patients with severe carotid artery stenosis.

Objectives: The purpose of this study was to determine the safety of carotid artery stenting with a unique distal embolic protection system in high-risk patients with severe carotid stenosis.

Background: Previous studies suggest that some patients with carotid stenosis and serious comorbid conditions are at high risk for carotid endarterectomy, and may be safely treated by carotid artery stenting.

Methods: A prospective non-randomized multicenter registry of 419 patients with severe carotid stenosis and high-risk features for carotid endarterectomy was conducted between April 2004 and October 2004.

Usefulness of optical coherent reflectometry with guided radiofrequency energy to treat chronic total occlusions in peripheral arteries (the GRIP trial).

Optical coherent reflectometry, a forward-looking, fiberoptic-guided device was used in 72 patients to direct radiofrequency energy across the central intraluminal portion of 75 chronic total occlusions in peripheral arteries (iliac, femoral, and popliteal) that failed attempts with conventional guidewires. The system was successful in crossing 76% of the chronic total occlusions with no clinical perforations or distal embolizations, and complications consisted of a single dissection greater than or equal to grade C.