Clinical Outcomes of Non-Stent-Based Interventions for Symptomatic Below-the-Knee Peripheral Artery Disease in the Excellence in Peripheral Artery Disease (XLPAD) Registry.

For endovascular treatment of below-the-knee (BTK) peripheral artery disease (PAD), independently adjudicated real-world outcomes comparing non-stent-based balloon angioplasty (percutaneous transluminal angioplasty) and adjunctive treatments with or without a concomitant ipsilateral femoropopliteal (FP) artery intervention are scarce. A total of 1,060 patients from the multicenter XLPAD registry who underwent non-stent-based BTK PAD intervention between 2006 and 2021 were included. The primary outcome was the 1-year incidence of major adverse limb events (MALEs), a composite of all-cause death, any amputation, or clinically driven repeat revascularization.

Safety and Efficacy of Radial Artery Access for Peripheral Vascular Intervention: A Single-Center Experience.

Radial artery (RA) access has been increasingly utilized for coronary procedures because of lower rates of access-site complications and improved patient satisfaction. However, limited data are available for RA access for peripheral vascular intervention (PVI). We performed a retrospective review of 143 patients who underwent PVI through RA access from February 2020 to September 2022 at a single institution.

Solid state, pulsed-wave 355 nm UV laser atherectomy debulking in the treatment of infrainguinal peripheral arterial disease: The Pathfinder Registry.

Background: Atherectomy is an important option for debulking atherosclerotic plaque from diseased arteries in patients with infrainguinal arterial disease. Laser atherectomy uses a high-powered laser to remove the plaque from the arteries to restore blood flow.

Aims: The Pathfinder multicenter registry was initiated to evaluate the safety and efficacy of the 355 nm laser atherectomy system in a real-world setting for the treatment of de novo, re-stenotic and in-stent restenosis (ISR) lesions in infrainguinal arteries of patients with peripheral artery disease (PAD).

The REDUCE HTN: REINFORCE: Randomized, Sham-Controlled Trial of Bipolar Radiofrequency Renal Denervation for the Treatment of Hypertension.

Objectives: The aim of this study was to investigate bipolar radiofrequency renal denervation in patients with hypertension not receiving medications at baseline.

Background: A blood pressure-reducing effect of renal denervation has been difficult to isolate in clinical investigations.

Methods: REDUCE HTN: REINFORCE (Renal Denervation Using the Vessix Renal Denervation System for the Treatment of Hypertension) was a randomized, sham-controlled multicenter trial.

Carotid Artery Stenting in Asymptomatic Carotid Artery Stenosis: JACC Review Topic of the Week.

The advance of therapies to reduce the stroke impact of asymptomatic carotid artery stenosis has proved difficult over the last decade. Disagreement concerning the underlying randomized control trials has limited entry into the care arena of endovascular therapies. Recently, advances in percutaneous therapies for carotid artery disease have been reported and provide a substantial database supporting the further incorporation of endovascular-based therapies in patients who need revascularization and meet selection criteria.

SCAI/ACVP expert consensus statement on cardiovascular catheterization laboratory economics: If the cath lab is your home you should understand its finances: This statement was endorsed by the Alliance of Cardiovascular Professionals (ACVP) in April 2019.

This article is intended for any physician, administrator, or cardiovascular catheterization laboratory (CCL) staff member who desires a fundamental understanding of finances and economics of CCLs in the United States. The authors' goal is to illuminate general economic principles of CCL operations and provide details that can be used immediately by CCL leaders. Any article on economics in medicine should start by acknowledging the primacy of the principles of medical ethics.

Comparative Assessment of Procedure Cost and Outcomes Between Guidewire and Crossing Device Strategies to Cross Peripheral Artery Chronic Total Occlusions.

Objectives: The aim of this study was to assess actual procedural costs and outcomes comparing wire-catheter and dedicated chronic total occlusion (CTO) device strategies to cross peripheral artery CTOs.

Background: Peripheral artery CTO interventions are frequently performed, but there are limited data on actual procedural costs and outcomes comparing wire-catheter and dedicated CTO devices.

Methods: The XLPAD (Excellence in Peripheral Artery Disease Intervention) registry (NCT01904851) was accessed to retrospectively compare cost and 30-day and 12-month outcomes of wire-catheter and crossing device strategies for treatment of infrainguinal peripheral artery CTO.

Impact of lesion location on procedural and acute angiographic outcomes in patients with critical limb ischemia treated for peripheral artery disease with orbital atherectomy: A CONFIRM registries subanalysis.

Objectives: This analysis compares the procedural and acute angiographic outcomes in patients with critical limb ischemia (CLI) treated with orbital atherectomy in above-the-knee (ATK)/popliteal (POP) lesions versus below-the-knee (BTK) lesions.

Background: Lesion location affects the procedural outcomes and the opportunity for limb salvage in patients with CLI suffering from peripheral artery disease (PAD).

Methods: The CONFIRM registry series was analyzed and includes 1109 real-world patients (1544 lesions) suffering from CLI treated with orbital atherectomy.

Subanalysis of the CONFIRM Registries: Acute Procedural Outcomes in Claudicant and Critical Limb Ischemia Patients With Varying Levels of Calcification Treated for Peripheral Arterial Disease With Orbital Atherectomy.

Purpose: Patients with peripheral arterial disease (PAD) can be classified into groups based upon the severity of the disease using the Rutherford classification system. This analysis compares the procedural outcomes of PAD patients treated with orbital atherectomy stratified by Rutherford class (1-3 = intermittent claudication; 4-6 = critical limb ischemia [CLI]), and acute angiographic outcomes of these patients stratified by degree of lesion calcification.

Methods: The CONFIRM registry series was analyzed and included 1697 patients with intermittent claudication (Rutherford class 1-3) and 1320 patients with CLI (Rutherford class 4-6) treated with orbital atherectomy.

Recanalization of infrainguinal chronic total occlusions with the crosser system: results of the PATRIOT trial.

Purpose: To evaluate the angiographic and functional outcomes of the Crosser chronic total occlusion (CTO) recanalization system used to facilitate crossing of infrainguinal occlusions resistant to conventional guidewire techniques.

Methods: Eighty-five patients with a previous or concurrent failed attempt to cross a CTO using conventional guidewire techniques were enrolled at eight United States centers. Occlusions were at least 30 days old and ≤30 cm in length.

Pooled analysis of the CONFIRM Registries: outcomes in renal disease patients treated for peripheral arterial disease using orbital atherectomy.

Background: Patients with renal disease typically have severely calcified peripheral arterial disease. As a result, this population may have worse clinical outcomes following endovascular intervention compared to patients without renal insufficiency. Clinical trials typically exclude this patient population.

Final results of the Chronic Total Occlusion Crossing With the Ocelot System II (CONNECT II) study.

Purpose: To evaluate the safety and effectiveness of the optical coherence tomography-guided Ocelot catheter to cross femoropopliteal chronic total occlusions (CTOs).

Methods: The CONNECT II study was a prospective, multicenter, non-randomized single-arm study of the safety and effectiveness of the Ocelot catheter in CTO crossing. Key inclusion criteria were a 99% to 100% stenosed femoropopliteal segment, lesion length between 1 and 30 cm, and resistance to guidewire crossing.

Technique optimization of orbital atherectomy in calcified peripheral lesions of the lower extremities: the CONFIRM series, a prospective multicenter registry.

Objectives: The purpose of CONFIRM registry series was to evaluate the use of orbital atherectomy (OA) in peripheral lesions of the lower extremities, as well as optimize the technique of OA.

Background: Methods of treating calcified arteries (historically a strong predictor of treatment failure) have improved significantly over the past decade and now include minimally invasive endovascular treatments, such as OA with unique versatility in modifying calcific lesions above and below-the-knee.

Methods: Patients (3135) undergoing OA by more than 350 physicians at over 200 US institutions were enrolled on an "all-comers" basis, resulting in registries that provided site-reported patient demographics, ABI, Rutherford classification, co-morbidities, lesion characteristics, plaque morphology, device usage parameters, and procedural outcomes.

Utility and feasibility of ultrasound-guided access in patients with critical limb ischemia.

Background: Patients with advanced peripheral vascular disease (PVD) and critical limb ischemia (CLI) require immediate revascularization to improve blood flow and prevent amputation. Vascular, and especially tibial, access is arguably a very important part of the procedure. Utilization of ultrasound (US) guidance to access the peripheral vessels will maximize success and decrease the risk of complications.

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.

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.

A prospective multicenter registry of laser therapy for degenerated saphenous vein graft stenosis: the COronary graft Results following Atherectomy with Laser (CORAL) trial.

Purpose: The primary aim of this study was to prospectively evaluate the safety and efficacy of Excimer laser atherectomy as a primary treatment strategy in consecutively eligible patients presenting for percutaneous coronary intervention (PCI) of degenerated saphenous vein graft (SVG) lesions using a multicenter registry. Prior single-center experience suggested that laser atherectomy may decrease acute procedural complications during treatment of degenerated SVGs, including lesions not amenable to distal protection devices (DPDs).

Methods And Materials: The COronary graft Results following Atherectomy with Laser investigators enrolled 98 patients at 18 centers between June 23, 2003, and October 4, 2004, with greater than 50% stenosis of an SVG who presented for PCI due to angina pectoris or objective evidence of myocardial ischemia in a concordant myocardial distribution.

Transcutaneous ultrasound-guided endovascular crossing of infrainguinal chronic total occlusions.

Currently available techniques for the endovascular treatment of infrainguinal arterial chronic total occlusions (CTOs) require long procedure duration, large contrast volumes, complex subintimal dissection technique, and have low-intermediate success rates. Inability to remain intraluminal and/or reenter the true lumen after subintimal dissection remains the main reasons for procedural failure. We report for the first time a novel, simple, and reproducible technique that can significantly improve both the success and safety of endovascular intraluminal crossing of totally occluded peripheral arterial segments: the transcutaneous ultrasound-guided (TUG)-CTO technique.

Safety and effectiveness of the INVATEC MO.MA proximal cerebral protection device during carotid artery stenting: results from the ARMOUR pivotal trial.

Objective: The multicenter ARMOUR (ProximAl PRotection with the MO.MA Device DUring CaRotid Stenting) trial evaluated the 30-day safety and effectiveness of the MO.MA Proximal Cerebral Protection Device (Invatec, Roncadelle, Italy) utilized to treat high surgical risk patients undergoing carotid artery stenting (CAS).

Excimer laser-assisted angioplasty for infrainguinal artery disease.

After nearly 2 decades of research and experimentation with laser-assisted angioplasty, the xenon-hydrogen chloride excimer laser emerged as the laser device best suited for the treatment of peripheral artery disease. Emitting light at a wavelength of 308 nm, this laser utilizes a nonthermal mechanism of action to ablate plaque and thrombus in powerful discrete pulses. The excimer laser is particularly useful for the treatment of complex conditions, such as long chronic occlusions in the superficial femoral artery and in those patients with below-the-knee disease and critical limb ischemia who may not be good candidates for bypass surgery.

Primary cryoplasty therapy provides durable support for limb salvage in critical limb ischemia patients with infrapopliteal lesions: 12-month follow-up results from the BTK Chill Trial.

Purpose: To report the 12-month follow-up data from the prospective 16-center Below-the-Knee (BTK) Chill Trial, which examined the use of primary cryoplasty for BTK occlusive disease in patients with critical limb ischemia (CLI).

Methods: The trial included 108 patients (77 men; mean age 73 +/- 11 years, range 41-101) with CLI (Rutherford categories 4-6) involving 111 limbs with 115 target infrapopliteal lesions. Angiographic inclusion criteria were reference vessel diameter > or = 2.

Treatment of complex superficial femoral artery lesions with PolarCath cryoplasty.

Use of cryoplasty in patients with severely symptomatic (Rutherford category > or =3) superficial femoral artery (SFA) disease has not been systematically evaluated. From August 2006 to October 2007, 27 consecutive, severely symptomatic patients with 39 lesions in 36 limbs underwent SFA cryoplasty using the PolarCath at 2 centers. Mean age was 74 +/- 12 years and 48% were men; 41% had diabetes, 59% had coronary artery disease, and 61% had complex lesions (ostial, calcified, chronic total occlusion, in-stent restenosis, or length > or =150 mm).