BIOFLOW-III satellite-One-year clinical outcomes of diabetic patients treated with a biodegradable polymer sirolimus-eluting stent and comprehensive medical surveillance.

Background: Drug-eluting stents with biodegradable polymer might be particularly useful in diabetic patients who are at increased risk for target lesion/target vessel revascularization. We therefore aimed at assessing the safety and performance of a biodegradable polymer sirolimus-eluting stent (BP-SES) in combination with comprehensive optimal medical therapy following coronary interventions.

Methods: This prospective, multicenter registry was conducted at six centers in Israel.

Ethnic disparity in the clinical characteristics of patients with heart failure.

Aims: The characteristics of heart failure (HF) patients of different ethnic backgrounds in Israel are unknown. The purpose of the present study was to evaluate the clinical characteristics of Arab vs. Jewish patients with chronic HF.

Clinical outcome of patients with chronic heart failure followed in a specialized heart failure center.

Background: Patients with heart failure (HF) have a poor prognosis. Heart failure centers with specialized nurse-supervised management programs have been proposed to improve prognosis.

Objectives: To evaluate the clinical outcome of patients with HF treated at a multidisciplinary HF center of Clalit Health Services in Jerusalem in collaboration with Hadassah University Hospital.

Safety and efficacy of frequency domain optical coherence tomography in pigs.

Aims: To determine the safety and efficacy of frequency domain OCT, which can scan at much higher rates and make it possible to avoid an occlusion balloon and image during an angiographic injection through guide catheter. The catheters have diameters ranging from 2.7 to 3.

A third generation ultra-thin strut cobalt chromium stent: histopathological evaluation in porcine coronary arteries.

Aims: The present study was designed to evaluate a novel third generation bare-metal stent (BMS) comprised of an ultra-thin-strut, cobalt-chromium platform with fixed geometry, uniform cell size, and superior surface finish in a porcine coronary artery model.

Methods And Results: A total of 47 BMS of two types were implanted in pig coronary arteries using QCA to optimise stent apposition: a commercially available cobalt alloy thin-strut stent (91 microm) as control (Driver; n=17), and an ultra-thin-strut (65 microm) cobalt-chromium stent (Protea; n=18). Animals underwent angiographic restudy and termination one week and one month post-implant for coronary artery histology.

Novel fully bioabsorbable salicylate-based sirolimus-eluting stent.

Aims: The concept of fully biodegradable stents has emerged as an attractive alternative to current permanent metallic stents, mainly as a potential solution to avoid late stent thrombotic events. We sought to evaluate a novel, fully bioabsorbable sirolimus-eluting stent (SES) synthesised entirely from a unique salicylic-acid polymer, in a clinically relevant animal model.

Methods And Results: Fully biodegradable balloon-expandable stents (n=45) were implanted in a porcine coronary arteries using quantitative coronary angiography (QCA) and intravascular ultrasound (IVUS) to optimise stent apposition.

Effect of gradual computerized angioplasty on outcomes of patients undergoing coronary stenting.

Mechanical trauma caused by percutaneous coronary intervention is a major factor contributing to subsequent cardiac events, restenosis, and the need for target lesion revascularization (TLR). To minimize this trauma, we developed a Computerized Angioplasty Pressure Sensor and Inflator Device (CAPSID) for gradual inflation. The objective of the present prospective randomized study was to examine whether the use of this novel device reduced TLR, as well as cardiac events, in patients undergoing stenting.

Impact of the definition utilized on the rate of contrast-induced nephropathy in percutaneous coronary intervention.

Several definitions have been used to assess rates of contrast-induced nephropathy (CIN) in patients undergoing percutaneous coronary intervention (PCI). Whether the definition influences observed rates of CIN is unclear. The Oxilan Registry was the first-ever prospective analysis of the efficacy and safety of ioxilan (low-osmolar and low-viscosity contrast medium), including rates of CIN assessed by multiple definitions, in PCI.

Abnormal vasomotor function of porcine coronary arteries distal to sirolimus-eluting stents.

Objectives: This study sought to determine vasomotor functional responses of conduit coronary artery distal to bare-metal stents (BMS), polymer-only stents (POLY), and sirolimus-eluting stents (SES) in a clinically relevant animal model.

Background: Drug-eluting stents (DES) reduce in-stent restenosis, and also affect neointima formation and vascular remodeling in downstream coronary segments. Whether distal artery vasomotor function is also influenced by DES has not been determined.

Comparison of the clinical characteristics of apical and non-apical variants of "broken heart" (takotsubo) syndrome in the United States.

Objectives: The present study was designed to delineate and compare the clinical characteristics of patients with apical and non-apical takotsubo syndrome in a high-volume U.S. hospital.

Clinical and angiographic features of small vessel stenting in the drug-eluting stent era.

Hypothesis: This study was designed to investigate the clinical and angiographic features and procedural outcomes of small-vessel stenting in a real-world experience during the transition era between drug-eluting stents (DES) and bare-metal stents (BMS).

Methods: Using one of the largest single-institutional cohorts, this study evaluated all patients who underwent percutaneous coronary intervention (PCI) from 2002 through 2005. Analysis was restricted to patients receiving a single stent or undergoing balloon-only angioplasty in a single anatomic site.

Passive and active polymer coatings for intracoronary stents: novel devices to promote arterial healing.

Coronary stent implantation is the second great advance in the treatment of obstructive coronary artery disease since the introduction of balloon catheter angioplasty. However, in-stent restenosis (ISR) caused by neointimal hyperplasia has been a major limitation of stents, occurring in up to 30% of cases. Advances in coronary stent technology both in terms of stent design and function and especially drug-eluting stents (DES) have significantly improved the safety and efficacy of percutaneous coronary intervention (PCI) with stenting, including marked reduction in ISR.

Ambulatory discharge after transradial coronary intervention: Preliminary US single-center experience (Same-day TransRadial Intervention and Discharge Evaluation, the STRIDE Study).

Background: Although the safety and cost-effectiveness of same-day discharge after uncomplicated transradial percutaneous coronary intervention (TR-PCI) is well established in Europe and Asia, such data are not available for US patients.

Methods: All patients who underwent TR-PCI at our high-volume US medical center between 2004 and 2007 were included in this study. The primary end point was in-hospital adverse clinical outcomes between 6 and 24 hours postprocedure.

Low-dose paclitaxel elution by novel bioerodible sol-gel coating on stents inhibits neointima with low toxicity in porcine coronary arteries.

Objectives: The present study was designed to evaluate a novel bioerodible sol-gel film coated paclitaxel-eluting stent (sol-gel-PES, 3 microg per stent) in a porcine coronary artery model.

Background: Although current polymer-based PES decrease restenosis, the permanent polymer and bound drug have raised concerns regarding delayed vessel healing and late stent thrombosis.

Methods: Polymer-based PES (poly-PES, n = 8), sol-gel-PES (n = 15), bare metal (BMS, n = 14), and sol-gel film only (sham, n = 12), stents were implanted in 17 juvenile pigs.

High incidence of intramural thrombus after overlapping paclitaxel-eluting stent implantation: angioscopic and histopathologic analysis in porcine coronary arteries.

Background: Systematic analysis of in vivo angioscopy and postmortem histopathology for paclitaxel-eluting stents (PES) has not been previously reported. We assessed 1-month angioscopic and histopathologic sequelae of overlapping PES in pig coronary arteries.

Methods And Results: Overlapping PES and bare-metal stents (BMS; n=9, one pair per pig) were implanted, and animals were euthanized at 1 month.

Novel bioabsorbable salicylate-based polymer as a drug-eluting stent coating.

Background: Permanent polymers used in current drug-eluting stents (DES) can trigger chronic inflammation and hypersensitivity reactions, which may contribute to the increased risk of late thrombosis and rebound restenosis. Therefore, optimal polymer selection and the use of completely absorbable but biocompatible polymers are expected to minimize these risks.

Objectives: We sought to evaluate a novel, potentially innately anti-inflammatory, bioabsorbable salicylate-based polymer as a DES coating, in a clinically relevant animal model.

Drug-eluting stents: present and future.

In-stent restenosis (ISR) caused by neointimal hyperplasia is the major drawback after percutaneous coronary intervention (PCI) for obstructive coronary disease, occurring in up to 40% of lesions. Recently, one of the most intriguing new therapies developed is drug-eluting stents (DES) that target the central phenomenon of cellular proliferation that causes ISR. The benefits of stent-based drug delivery include maximizing the local tissue levels of therapeutic agents while minimizing systemic toxicity.

Late angiographic stent thrombosis: the LAST straw for drug-eluting stents?

The long-term patency advantage of drug-eluting stents represents a quantum leap in the percutaneous treatment of ischemic heart disease. Although initial landmark trials demonstrated equivalent safety to bare-metal stents, subsequent follow-up analyses have suggested a slight late thrombotic risk. This widely publicized issue poses major public health implications for the medical and lay communities.

Evaluation of a novel slow-release paclitaxel-eluting stent with a bioabsorbable polymeric surface coating.

Objectives: We sought to evaluate a new second-generation drug-eluting stent (DES), comprising a slow-release biodegradable polylactide coglycolide (PLGA) polymer and low-dose paclitaxel on a thin-strut cobalt chromium stent platform, in a clinically relevant animal model.

Background: Our previous work demonstrated subacute vascular toxicity and necrosis triggering late excess neointima in pig coronaries, with a moderate paclitaxel dose eluted from an erodible polymer. The use of slower-releasing absorbable polymers with lower doses of paclitaxel is expected to minimize such adverse outcomes.

Comparison of multidetector 64-slice computed tomographic angiography to coronary angiography to assess the patency of coronary artery bypass grafts.

This study prospectively evaluated the diagnostic accuracy of 64-slice computed tomographic angiography (CTA) in assessing the patency of coronary artery bypass grafts compared with invasive coronary angiography. In total 147 bypass grafts (100 venous grafts and 47 mammary artery grafts) were evaluated in 50 consecutive patients. Contrast-enhanced 64-slice CTA was performed and compared with invasive angiography.

Risk characteristics of Arab and Jewish women with coronary heart disease in Jerusalem.

Background: There is little published information on the coronary risk characteristics of Palestinian women. However, there are documented lifestyle differences as well as socioeconomic inequalities between Arab and Jewish women in Israel.

Objectives: To compare the risk factor characteristics of coronary heart disease patients in Palestinian and Israeli women.

Comparison of 4 and 6 French catheters for coronary angiography: real-world modeling.

Background: Femoral artery vascular complications are the most common adverse events following cardiac catheterization. Smaller diameter introducer sheaths and catheters are likely to lower the puncture site complication rate but may hinder visualization.

Objectives: To evaluate the safety and angiographic quality of 4 French catheters.

The Straight Wire Sign: recognizing guidewire exit during percutaneous coronary intervention for chronic total occlusion.

Coronary perforation during PCI may be life threatening. Use of stiff wires during instrumentation of totally occluded arteries is a contributing factor. The "Straight Wire" sign presented here was realized from a case of coronary perforation encountered at our cath lab.

Toxic vessel reaction to an absorbable polymer-based paclitaxel-eluting stent in pig coronary arteries.

Objectives: The goal of this study was to evaluate a new drug-eluting stent (DES) comprising a bioabsorbable polymer eluting a moderate dose of paclitaxel in a clinically relevant animal model.

Background: Although DES limit restenosis, adverse vascular pathologies and toxicities continue to be of major concern. Optimization of DES components, especially completely absorbable polymers, may reduce these toxicities.