A universal drug delivery catheter for the treatment of infrapopliteal arterial disease using liquid therapy.

Objective: The objective of this study was to investigate the safety and feasibility of treating infrapopliteal lesions using a novel drug delivery catheter locally delivering liquid paclitaxel.

Background: Balloon angioplasty is currently the Gold Standard to treat below-the-knee disease; however, restenosis continues to be a great challenge following these percutaneous revascularization procedures.

Methods: The Occlusion Perfusion Catheter for Optimal Delivery of Paclitaxel for the Prevention of Endovascular Restenosis (COPPER-A) study-Below-the-Knee Cohort was a prospective, nonrandomized, multicenter, feasibility, and safety study that enrolled 35 patients at 11 participating sites.

Clinical Conference Proceedings: 15th Biennial International Andreas Gruentzig Society Meeting.

The International Andreas Gruentzig Society is an educational society of physicians and scientists interested in cardiovascular and related fields. Members cooperate in the advancement of knowledge and education through research, publication, study, and teaching in the fields of cardiovascular disease. This summary reflects the proceedings from the recent scientific meeting to assess current clinical problems and propose future directions and possible solutions.

Multidisciplinary approach to the diagnosis and management of patients with peripheral arterial disease.

Peripheral arterial disease (PAD) is frequently diagnosed after permanent damage has occurred, resulting in a high rate of morbidity, amputation, and loss of life. Early and ongoing diagnosis and treatment is required for this progressive disease. Lifestyle modifications can prevent or delay disease progression and improve symptoms.

Randomized controlled study of excimer laser atherectomy for treatment of femoropopliteal in-stent restenosis: initial results from the EXCITE ISR trial (EXCImer Laser Randomized Controlled Study for Treatment of FemoropopliTEal In-Stent Restenosis).

Objectives: The purpose of this study was to evaluate the safety and efficacy of excimer laser atherectomy (ELA) with adjunctive percutaneous transluminal angioplasty (PTA) versus PTA alone for treating patients with chronic peripheral artery disease with femoropopliteal bare nitinol in-stent restenosis (ISR).

Background: Femoropopliteal stenting has shown superiority to PTA for lifestyle-limiting claudication and critical limb ischemia, although treating post-stenting artery reobstruction, or ISR, remains challenging.

Methods: The multicenter, prospective, randomized, controlled EXCITE ISR (EXCImer Laser Randomized Controlled Study for Treatment of FemoropopliTEal In-Stent Restenosis) trial was conducted across 40 U.

Pilot trial of cryoplasty or conventional balloon post-dilation of nitinol stents for revascularization of peripheral arterial segments: the COBRA trial.

Objectives: The purpose of this study is to compare post-dilation strategies of nitinol self-expanding stents implanted in the superficial femoral artery of diabetic patients with peripheral arterial disease.

Background: Endovascular treatment of superficial femoral artery disease with nitinol self-expanding stents is associated with high rates of in-stent restenosis in patients with diabetes mellitus.

Methods: We conducted a prospective, multicenter, randomized, controlled clinical trial of diabetic patients to investigate whether post-dilation of superficial femoral artery nitinol self-expanding stents using a cryoplasty balloon reduces restenosis compared to a conventional balloon.

Treatment of subacute and chronic thrombotic occlusions of lower extremity peripheral arteries with the excimer laser: a feasibility study.

Background: Thrombus is highly prevalent in patients with recent symptoms (< 6 months) of claudication or limb ischemia due to an occluded culprit lower extremity vessels. Treatment of these thrombotic occlusions is challenging. In this feasibility study, the excimer laser (Spectranetics, Colorado Springs, CO) has been tested for its safety and ability to ablate thrombus in patients with recent arterial occlusions.

Excimer laser with adjunctive balloon angioplasty and heparin-coated self-expanding stent grafts for the treatment of femoropopliteal artery in-stent restenosis: twelve-month results from the SALVAGE study.

Objectives: The aim of the study is to evaluate the safety and effectiveness of treating femoropopliteal in-stent restenosis (ISR) with debulking with excimer laser followed by implantation of a VIABAHN endoprosthesis.

Background: The optimal treatment strategy for femoropopliteal ISR is unclear.

Methods: The SALVAGE study is a multicenter prospective registry involving nine US centers.

Percutaneous lower-extremity arterial interventions with primary balloon angioplasty versus Silverhawk atherectomy and adjunctive balloon angioplasty: randomized trial.

Purpose: Target lesion revascularization (TLR) with primary percutaneous transluminal angioplasty (PTA) versus SilverHawk atherectomy and adjunctive PTA of de novo infrainguinal disease has not been well defined. This study was conducted to compare the two approaches.

Materials And Methods: In this prospective, two-center randomized trial of PTA versus atherectomy of infrainguinal vessels, the primary endpoint of TLR was evaluated at 1 year.

Carotid artery stenting in high surgical risk patients using the FiberNet embolic protection system: the EPIC trial results.

Objective: The multicenter EPIC (FiberNet Embolic Protection System in Carotid Artery Stenting Trial) single-arm trial evaluated the 30-day outcomes of a new design concept for embolic protection during carotid artery stenting (CAS).

Background: Embolic protection filters available for use during CAS include fixed and over-the-wire systems that rely on embolic material capture within a "basket" structure. The FiberNet Embolic Protection System (EPS), which features a very low crossing profile, consists of a three-dimensional fiber-based filter distally mounted on a 0.

In-hospital safety and effectiveness of bivalirudin in percutaneous peripheral interventions: data from a real-world registry.

Purpose: To present real-world data to evaluate the safety and effectiveness of bivalirudin, a direct thrombin inhibitor, in an unselected group of patients undergoing percutaneous peripheral interventions (PPI).

Methods: Data were extracted from a prospectively collected peripheral vascular registry developed for quality assurance measures at 2 centers. Of 398 consecutive patients (195 men; mean age 69.

Outcomes of unselected recipients of sirolimus-eluting stents: the Cypher stent U.S. post-marketing surveillance registry.

Objective: To examine the 1-year safety and clinical outcomes associated with the post-marketing early unselected use of sirolimus-eluting stents (SES) in the United States.

Background: The safety and effectiveness of SES has been assessed in selected patients enrolled in pivotal randomized trials. This PMS registry was initiated to examine the safety and effectiveness of SES in an unselected population.

Excimer laser recanalization of femoropopliteal lesions and 1-year patency: results of the CELLO registry.

Purpose: To evaluate the safety and efficacy of a modified laser catheter designed for the endovascular treatment of peripheral artery disease (PAD) affecting the superficial femoral artery (SFA) and proximal popliteal artery.

Methods: The CliRpath Excimer Laser System to Enlarge Lumen Openings (CELLO) study was a single-arm, prospective registry conducted at 17 investigational sites in the United States. The primary endpoint was the reduction in index lesion percent diameter stenosis (% DS) measured by Doppler ultrasound following laser ablation prior to any adjunctive therapy.

Predictors of distal embolization in peripheral percutaneous interventions: a report from a large peripheral vascular registry.

Background: Distal embolization (DE) commonly occurs during peripheral percutaneous interventions (PPI) of the lower-extremity arterial vessels. In this study we evaluate the predictors of DE in a large cohort of patients undergoing PPI at our center.

Methods: Patients who experienced clinically significant DE (requiring further mechanical or pharmacologic therapy as per operator judgment) were extracted from a peripheral vascular registry that prospectively tracks demographics, clinical, procedural and outcome variables on patients undergoing PPI at our medical center and compared these to patients in the same registry who did not experience DE.

Treatment of left main coronary trifurcation lesions with the paclitaxel drug-eluting stent: mid-term outcomes from a tertiary medical center.

Background: Left main trifurcating coronary artery disease (LMTCAD) is a complex and challenging anatomy to treat percutaneously. We report on the immediate- and mid-term outcomes of 52 consecutive patients with LMTCAD treated with the Taxus(R) paclitaxel- eluting stent (PES) (Boston Scientific Corp., Natick, Mass.

Distal embolic event protection using excimer laser ablation in peripheral vascular interventions: results of the DEEP EMBOLI registry.

Purpose: To report the results from a single-center prospective registry (DEEP EMBOLI) established to evaluate distal embolization during percutaneous lower extremity interventions using excimer laser ablative therapy.

Methods: Elective patients with infrainguinal occlusive disease were eligible for this registry if the lesion(s) met one or more of these angiographic criteria: (1) moderate or severe calcification of any length, (2) total occlusions of any length, (3) a filling defect, (4) irregular (ulcerated) lesions at least 30 mm in length, and/or (5) smooth, non-ulcerated lesions at least 50 mm in length. In all, 20 patients (15 women; mean age 70.

Dethrombosis of the lower extremity arteries using the power-pulse spray technique in patients with recent onset thrombotic occlusions: results of the DETHROMBOSIS Registry.

Purpose: To assess the presence of thrombus using intravascular ultrasound (IVUS) and evaluate the feasibility of combined thrombolysis [power-pulse spray (P-PS)] and rheolytic thrombectomy (RT) in patients with recent-onset limb ischemia (<6 months) due to total occlusion of at least 1 infrainguinal vessel.

Methods: Seventeen patients (12 women; mean age 68.3+/-10.

Intermediate term outcomes with bifurcation coronary stenting using the paclitaxel drug-eluting stent: a single centre experience.

Background: Percutaneous treatment of bifurcation coronary artery disease (BCD) is complex and, in the era of bare metal stents (BMS), was reported to have a high rate of repeat target lesion revascularization (TLR). Paclitaxel drug-eluting stents (PES) have been used in the treatment of BCD, with better overall outcomes than BMS. Also, acute stent thrombosis (AST), with an incidence ranging from 2.

Preventing lower extremity distal embolization using embolic filter protection: results of the PROTECT registry.

Purpose: To report the results from a single-center prospective registry (PROTECT) established to evaluate the safety and effectiveness of embolic filter protection (EFP) in reducing distal embolization during percutaneous lower extremity interventions.

Methods: Patients undergoing angioplasty, stenting, or SilverHawk atherectomy and adjunctive balloon angioplasty for infrainguinal occlusive disease were eligible if the lesion(s) met one or more of these angiographic criteria: (1) moderate or severe calcification of any length, (2) total occlusions of any length, (3) a filling defect, (4) irregular (ulcerated) lesions at least 30 mm in length, and/or (5) smooth, non-ulcerated lesions at least 50 mm in length. The primary angiographic outcome was the ability of the filter to prevent angiographically visible distal embolization, slow flow, and loss of distal tibial runoff with or without capturing macrodebris.

Utilization of GP IIb/IIIa inhibitors in peripheral percutaneous interventions: current applications and in-hospital outcomes at a tertiary referral center.

The pattern of use of glycoprotein (GP) IIb/IIIa receptor inhibitors in peripheral percutaneous interventions (PPI) remains unclear. Data on patients who received GP IIb/IIIa inhibitors during PPI were extracted from a prospective registry that tracks demographic, angiographic and in-hospital outcomes of patients at 2 medical centers. Primary success was defined as establishing thrombolysis in myocardial infarction (TIMI) 3 flow and < 30% residual in vessels treated.

Embolic protection and platelet inhibition during renal artery stenting.

Background: Preservation of renal function is an important objective of renal artery stent procedures. Although atheroembolization can cause renal dysfunction during renal stent procedures, whether adjunctive use of embolic protection devices or glycoprotein IIb/IIIa inhibitors improves renal function is unknown.

Methods And Results: One hundred patients undergoing renal artery stenting at 7 centers were randomly assigned to an open-label embolic protection device, Angioguard, or double-blind use of a platelet glycoprotein IIb/IIIa inhibitor, abciximab, in a 2x2 factorial design.

Elevated levels of homocysteine predict cardiovascular death, nonfatal myocardial infarction, and symptomatic bypass graft disease at 2-year follow-up following coronary artery bypass surgery.

Severe graft disease occurs in patients at a rate of approximately 15% within the first year of coronary artery bypass grafting (CABG). In this study, the authors examined predictors of the combined end point of death, nonfatal myocardial infarction (MI), and bypass graft disease at 2-year follow-up after CABG. One hundred twenty-one consecutive patients were included in this study after informed consent was obtained.

Interatrial septal defect closure for cerebrovascular accidents: exploring the role of various anticoagulants.

Background: The role of different anticoagulants in reducing in-hospital complications in patients undergoing closure of interatrial septal defects (IASD) is unknown. In this study, we review our own experience with IASD closure data to determine if in-hospital complications and ambulation time are influenced by the use of various anticoagulants.

Methods: Fifty-five consecutive patients with a history of unexplainable stroke or transient ischemic attacks (TIA), with the exception of the presence of an IASD, were included in this study.