Comparison of outcomes of percutaneous deep venous arterialization in multiple practice settings.

OBJECTIVE: We compared the efficacy of percutaneous deep venous arterialization (pDVA) in patients with no-option chronic limb-threatening ischemia in the hospital vs in office-based laboratory (OBL) settings. METHODS: A retrospective chart review was performed of all patients who underwent pDVA using off-the-shelf devices from January 2018 to March 2023 in a hospital and an OBL. We identified 73 eligible patients, 41 from a hospital setting (59% male; median age, 72 years; interquartile range, 18 years) and 32 from an OBL setting (59% males; 67 years; interquartile range, 16 years). All eligible patients were deemed to have no-option critical limb ischemia, had at least one patent proximal tibial artery available for the creation of an arteriovenous anastomosis, and were classified as having Rutherford classification IV or higher peripheral arterial disease. Patients were ineligible if classified as Rutherford classification III or lower, had active infection, did not have at least one appropriate venous target, and/or had rapidly progressing wounds requiring immediate major amputation. The primary outcome was major amputation-free survival (AFS). Secondary outcomes included technical success, limb salvage, survival, primary patency, reintervention rate, adverse events, and partial and complete wound healing. Outcomes were evaluated using Kaplan-Meier method, log-rank, and two-stage procedure tests. RESULTS: Technical success was achieved in 70 patients (96%) with 1 hospital (2.4%) and 2 OBL (6.3%) patients lost to follow-up. Major AFS estimates at 6 months, 1 year, and 2 years were 51.4%, 40.4%, and 30.2% in the hospital group and 69.4%, 54.0%, and 49.5% in the OBL group, respectively. Partial wound healing estimates at 6 months, 1 year, and 2 years were 27.5%, 71.7%, and 81.2% in the hospital group and 62.7% at all time points in the OBL group. Complete wound healing estimates at 6 months, 1 year, and 2 years were 6.7%, 33.3%, and 33.3% in the hospital group and 5.3%, 37.7%, and 41.6% in the OBL group, respectively. There was no significant difference in major AFS (P = .13), limb salvage (P = .07), survival (P = .69), primary patency (P = .53), partial (P = .08), or complete wound healing (P = .79) between groups. Reintervention was performed in 8 hospital (20.5%) and 14 OBL (45.2%) patients. CONCLUSIONS: pDVA is a feasible and safe procedure for no-option critical limb ischemia in the hospital and OBL setting without significant differences in outcomes at ≤2 years.

PACE: randomized, controlled, multicentre, multinational, phase III study of PLX-PAD for critical limb ischaemia in patients unsuitable for revascularization: randomized clinical trial.

BACKGROUND: Revascularization is the primary treatment modality for chronic limb-threatening ischaemia (CLTI), but is not feasible in all patients. PLX-PAD is an off-the-shelf, placental-derived, mesenchymal stromal cell-like cell therapy. This study aimed to evaluate whether PLX-PAD would increase amputation-free survival in people with CLTI who were not candidates for revascularization. METHODS: People with CLTI and minor tissue loss (Rutherford 5) who were unsuitable for revascularization were entered into a randomized, parallel-group, placebo-controlled, multinational, blinded, trial, in which PLX-PAD was compared with placebo (2 : 1 randomization), with 30 intramuscular injections (0.5 ml each) into the index leg on days 0 and 60. Planned follow-up was 12-36 months, and included vital status, amputations, lesion size, pain and quality-of-life assessments, haemodynamic parameters, and adverse events. RESULTS: Of 213 patients enrolled, 143 were randomized to PLX-PAD and 70 to placebo. Demographics and baseline characteristics were balanced. Most patients were Caucasian (96.2%), male (76.1%), and ambulatory (85.9%). Most patients (76.6%) reported at least one adverse event, which were mostly expected events in CLTI, such as skin ulcer or gangrene. The probability of major amputation or death was similar for placebo and PLX-PAD (33 and 28.6% respectively; HR 0.93, 95% c.i. 0.53 to 1.63; P = 0.788). Revascularization and complete wound healing rates were similar in the two groups. A post hoc analysis of a subpopulation of 121 patients with a baseline haemoglobin A1c level below 6.5% showed improved 12-month amputation-free survival (HR 0.46, 0.21 to 0.99; P = 0.048). CONCLUSION: Although there was no evidence that PLX-PAD reduced amputation-free survival in the entire study population, benefit was observed in patients without diabetes mellitus or whose diabetes was well controlled; this requires confirmation in further studies. Trial registration: NCT03006770 (http://www.clinicaltrials.gov); 2015-005532-18 (EudraCT Clinical Trials register - Search for 2015-005532-18).

Percutaneous Deep Venous Arterialization in Patients with No-Option Critical Limb Ischemia Performed in an Office-Based Laboratory Setting.

PURPOSE: To evaluate the feasibility and safety of percutaneous deep venous arterialization (pDVA) performed in an office-based laboratory (OBL) for patients with no-option critical limb ischemia (CLI). MATERIALS AND METHODS: A retrospective chart review was performed of all patients who underwent pDVA using commercially available devices from January 2018 to November 2021 in a single OBL. In total, 22 patients (10 males and 12 females; Rutherford 4, 5, and 6: n = 1, 8, and 13, respectively) were identified with a median follow-up of 140 days. Amputation-free survival, wound healing, pDVA patency, and overall survival were evaluated at 30 days, 6 months, and throughout the remaining follow-up period. RESULTS: All patients had undergone failed previous attempts at endovascular arterial reconstruction. At 6 months after procedure, 6.4% of arteriovenous conduits remained patent; 83.3% (10/12) of patients experienced complete or partial wound healing. In addition, 78.6% of patients avoided an above-ankle amputation, and overall survival was 83.6%. Nine patients underwent endovascular reinterventions at 6 months. One mild adverse event and 4 moderate adverse events occurred after procedure, and 1 cardiac death occurred 5 days after procedure. CONCLUSIONS: pDVA is safe and feasible in the OBL for patients with no-option CLI. Many patients avoided an above-ankle amputation during the study period despite low overall pDVA patency.

Randomized controlled trial of mechanical thrombectomy vs catheter-directed thrombolysis for acute hemodynamically stable pulmonary embolism: Rationale and design of the PEERLESS study.

BACKGROUND: The identification of hemodynamically stable pulmonary embolism (PE) patients who may benefit from advanced treatment beyond anticoagulation is unclear. However, when intervention is deemed necessary by the PE patient's care team, data to select the most advantageous interventional treatment option are lacking. Limiting factors include major bleeding risks with systemic and locally delivered thrombolytics and the overall lack of randomized controlled trial (RCT) data for interventional treatment strategies. Considering the expansion of the pulmonary embolism response team (PERT) model, corresponding rise in interventional treatment, and number of thrombolytic and nonthrombolytic catheter-directed devices coming to market, robust evidence is needed to identify the safest and most effective interventional option for patients. METHODS: The PEERLESS study (ClinicalTrials.gov identifier: NCT05111613) is a currently enrolling multinational RCT comparing large-bore mechanical thrombectomy (MT) with the FlowTriever System (Inari Medical, Irvine, CA) vs catheter-directed thrombolysis (CDT). A total of 550 hemodynamically stable PE patients with right ventricular (RV) dysfunction and additional clinical risk factors will undergo 1:1 randomization. Up to 150 additional patients with absolute thrombolytic contraindications may be enrolled into a nonrandomized MT cohort for separate analysis. The primary end point will be assessed at hospital discharge or 7 days post procedure, whichever is sooner, and is a composite of the following clinical outcomes constructed as a hierarchal win ratio: (1) all-cause mortality, (2) intracranial hemorrhage, (3) major bleeding, (4) clinical deterioration and/or escalation to bailout, and (5) intensive care unit admission and length of stay. The first 4 components of the win ratio will be adjudicated by a Clinical Events Committee, and all components will be assessed individually as secondary end points. Other key secondary end points include all-cause mortality and readmission within 30 days of procedure and device- and drug-related serious adverse events through the 30-day visit. IMPLICATIONS: PEERLESS is the first RCT to compare 2 different interventional treatment strategies for hemodynamically stable PE and results will inform strategy selection after the physician or PERT determines advanced therapy is warranted.

Dissections After Infrainguinal Percutaneous Transluminal Angioplasty: A Systematic Review and Current State of Clinical Evidence.

Purpose: To systematically review the literature and extract information on the definitions, prevalence, implications, and treatment of dissections after infrainguinal balloon angioplasty, with a goal of summarizing current data and identifying gaps in knowledge to help direct future research. Materials and Methods: A systematic review was performed according to the PRISMA guidelines. Medline (PubMed), Scopus, and Cochrane CENTRAL databases were reviewed for prospective and retrospective studies reporting dissection identification, characterization, incidence, severity, and/or outcomes after infrainguinal balloon angioplasty up to January 30, 2019. The electronic search resulted in 288 studies. From these, 153 full-text articles were assessed, and 51 published from 1964 to 2018 were selected as relevant to this systematic review. Because of the significant between-study differences in lesion characteristics, reporting methods, and lack of core laboratory adjudication, the findings were summarized from each study, but the results were not pooled. Results: The mechanism of percutaneous transluminal angioplasty (PTA) consists of adventitial stretching, medial necrosis, and controlled dissection or plaque fracture. PTA-induced dissections can precipitate pathological high and low shear hemodynamic defects and have been implicated as a contributing factor in procedural complications as well as restenosis at the treatment site. The development of significant dissection after PTA often leads to the use of adjunctive therapies, including stent placement. Despite the ubiquitous nature of dissection after balloon angioplasty (incidence 7.4% to 84%), limited data are available to categorize dissections in the peripheral arteries and direct subsequent treatments to improve vessel patency. With the increased utilization of drug-coated balloon angioplasty, understanding the outcomes of postangioplasty dissection has become increasingly important, as the decision to treat dissections with additional strategies has therapeutic and economic implications. Conclusion: All post-PTA dissections in the femoropopliteal arteries may benefit from a treatment approach that ensures optimal hemodynamics with long-term durability in treated lesions. Further understanding the importance of postangioplasty dissections, along with the development of new technologies, will help optimize the patency of endovascular interventions.

Stenting and medical therapy for atherosclerotic renal-artery stenosis.

BACKGROUND: Atherosclerotic renal-artery stenosis is a common problem in the elderly. Despite two randomized trials that did not show a benefit of renal-artery stenting with respect to kidney function, the usefulness of stenting for the prevention of major adverse renal and cardiovascular events is uncertain. METHODS: We randomly assigned 947 participants who had atherosclerotic renal-artery stenosis and either systolic hypertension while taking two or more antihypertensive drugs or chronic kidney disease to medical therapy plus renal-artery stenting or medical therapy alone. Participants were followed for the occurrence of adverse cardiovascular and renal events (a composite end point of death from cardiovascular or renal causes, myocardial infarction, stroke, hospitalization for congestive heart failure, progressive renal insufficiency, or the need for renal-replacement therapy). RESULTS: Over a median follow-up period of 43 months (interquartile range, 31 to 55), the rate of the primary composite end point did not differ significantly between participants who underwent stenting in addition to receiving medical therapy and those who received medical therapy alone (35.1% and 35.8%, respectively; hazard ratio with stenting, 0.94; 95% confidence interval [CI], 0.76 to 1.17; P=0.58). There were also no significant differences between the treatment groups in the rates of the individual components of the primary end point or in all-cause mortality. During follow-up, there was a consistent modest difference in systolic blood pressure favoring the stent group (-2.3 mm Hg; 95% CI, -4.4 to -0.2; P=0.03). CONCLUSIONS: Renal-artery stenting did not confer a significant benefit with respect to the prevention of clinical events when added to comprehensive, multifactorial medical therapy in people with atherosclerotic renal-artery stenosis and hypertension or chronic kidney disease. (Funded by the National Heart, Lung and Blood Institute and others; ClinicalTrials.gov number, NCT00081731.).

Results From the VISIBILITY Iliac Study: Primary and Cohort Outcomes at 9 Months.

PURPOSE: To evaluate the safety and effectiveness of primary stenting of the common (CIA) or external iliac artery (EIA) using the Visi-Pro Balloon-Expandable Peripheral Stent System for treatment of stenotic, restenotic, or occluded lesions. METHODS: Between 2011 and 2012, 75 patients (mean age 64.2±8.9 years; 46 men) with Rutherford category 2-4 ischemia and atherosclerotic lesions ≤10 cm in length underwent iliac artery stenting at 17 centers in the United States and Europe. The primary outcome of the study was the major adverse event (MAE) rate at 9 months postprocedure [composite of periprocedural death, in-hospital myocardial infarction, clinically driven target lesion revascularization (CD-TLR), and amputation of the treated limb]. Secondary outcomes included 30-day MAE rate, 9-month primary patency, changes in ankle-brachial index (ABI) and the Walking Impairment Questionnaire at 30 days and 9 months postprocedure, device success, and clinically driven target vessel revascularization (CD-TVR) at 30 days and 9 months. Outcomes in specific patient cohorts (ie, gender, stent location, calcification severity, and lesion grade) were analyzed. RESULTS: Eighty-one stents were implanted in 61 CIA and 15 EIA lesions (41 with moderate/severe calcification). The mean lesion treated length was 29.3±13.9 mm. All devices were successfully deployed. MAE occurred in 3 (4.0%) of 75 subjects at 9 months. Primary patency and freedom from CD-TVR at 9 months were both 95.8%. ABI improved from 0.67±0.14 at baseline to 0.94±0.14 and 0.96±0.16 at 30 days and 9-month follow-up, respectively (p<0.001 for both). There were no differences with respect to any of the analyzed patient characteristics, including gender. CONCLUSION: Nine-month results of the VISIBILITY Iliac stent study ( ClinicalTrials.gov identifier NCT01402700) demonstrated safety and effectiveness for the treatment of atherosclerotic CIA and EIA lesions with the Visi-Pro stent across all treated cohorts.

Key Concepts in Critical Limb Ischemia: Selected Proceedings from the 2015 Vascular Interventional Advances Meeting.

Over 500,000 patients each year are diagnosed with critical limb ischemia (CLI), the most severe form of peripheral artery disease. CLI portends a grim prognosis; half the patients die from a cardiovascular cause within 5 years, a rate that is 5 times higher than a matched population without CLI. In 2014, the Centers for Medicare and Medicaid Services paid approximately $3.6 billion for claims submitted by hospitals for inpatient and outpatient care delivered to patients with CLI. Although significant advances in diagnosis, treatment, and follow-up of patients with CLI have been made, many challenges remain. In this article, we summarize selected presentations from the 2015 Vascular Interventional Advances Conference related to the modern demographics, diagnosis, and management of patients with CLI.

Above and below knee femoropopliteal VIABAHN®.

OBJECTIVES: To assess the clinical outcomes of VIABAHN® stent grafts deployed across the knee to those deployed above the knee. BACKGROUND: The placement of stent-grafts across the knee joint and extending into the distal popliteal artery has been avoided due to a perceived higher risk of stent fractures, restenosis, and thrombosis due to the unique hemodynamic forces in this region. METHODS: A retrospective evaluation was conducted of 114 patients in 127 limbs. Patients were divided into two groups based on the location of the distal end of the deployed VIABAHN® stent: above knee (AK) (n=89) in which the VIABAHN® implant ended at or above the femoral condyles and below the knee (BK) (n=38) with extension of the graft into the below knee popliteal segment. Study end points were loss of primary, assisted, and secondary patency. RESULTS: One year primary, assisted, and secondary patency rates in the AK versus BK group were 67.7% vs. 47.2% (P=0.0092), 77.1% vs. 53.7% (P=0.0022), and 86.3% vs. 59.8% (P=0.0035), respectively. Univariate analysis demonstrated an increased relative risk of a primary [RR=2.07 (P=0.001)], assisted [RR=2.34 (P=0.002)], or secondary events [RR=2.98 (P=0.002)] in patients when the stent was placed below the femoral condyles. Major amputations occurred in 10% of AK and 34% of BK patients (P=0.002). CONCLUSIONS: VIABAHN® stent grafts have a significantly lower clinical patency and higher rates of amputation when they extend across the knee joint.

Impact of glomerular filtration rate on clinical outcomes after carotid artery revascularization in 11,832 patients from the CARE registry.

OBJECTIVE: The aim of this study was to assess the association of kidney function with carotid artery revascularization outcomes in a large contemporary database. BACKGROUND: Chronic kidney disease (CKD) is associated with increased mortality and adverse cardiovascular events after coronary intervention. There are limited data evaluating the association between CKD and adverse events among patients undergoing carotid artery revascularization procedures. METHODS: The Carotid Artery Revascularization and Endarterectomy (CARE) Registry is a voluntary registry of 168 hospitals. Using data from the CARE Registry, we examined registry patients undergoing carotid artery revascularization by either carotid endarterectomy (CEA) or carotid artery stenting (CAS) from May 2005 through March 2010. Patients were divided into four groups according to their glomerular filtration rate (GFR), as estimated by the Modification of Diet in Renal Disease Study Group equation using preprocedural serum creatinine levels. RESULTS: The analysis included 11,832 patients who underwent carotid revascularization (6,899 CAS and 4,933 CEA). Patients with lower GFR were older, more frequently female, had more comorbidities, including hypertension, dyslipidemia, peripheral arterial disease, diabetes mellitus, chronic lung disease, ischemic heart disease, heart failure, and reduced left ventricular function, and were more likely to undergo CAS than CEA. In the overall population, CKD was associated with higher unadjusted in-hospital and 30-day rates of the combined endpoint of death, stroke, and myocardial infarction and the individual endpoint of stroke. After adjustment for baseline and preprocedural characteristics, CKD was not an independent predictor of adverse events in either CAS or CEA. CONCLUSIONS: Patients with CKD have a greater number of comorbidities and worse unadjusted in-hospital and 30-day outcomes; CKD was not, however, an independent predictor of in-hospital and 30-day outcomes after carotid artery revascularization.

Contrast-induced nephropathy.

Contrast-induced nephropathy (CIN) has been extensively studied since the 1950s due, in part, to its devastating adverse events. The intellectual push for additional investigation into pathogenesis and prevention has heightened in recent years due to increased utilization of contrast enhanced imaging studies. Lack of a universal CIN definition and varied glomerular filtration rate markers have resulted in a varied reported incidence. Risk assessment and risk reduction strategies have evolved over the past several years. Current evidence supports volume supplementation before the administration of intravascular contrast to reduce the hazard of CIN. Other strategies to reduce the risk of CIN, including low osmolar contrast media, N-acetylcysteine, and intrarenal fenoldopam therapy, have variable levels of evidence, and further randomized trials are necessary.

Sharp recanalization using a subintimal reentry device, angioplasty, and stent placement for severely symptomatic iliofemoral deep venous thrombosis secondary to congenital aplasia of the inferior vena cava.

Iliofemoral deep venous thrombosis (DVT) secondary to congenital caval abnormalities is uncommon but should be suspected in younger patients presenting with bilateral DVT. Prior reports have described thrombolytic therapy and angioplasty for noncongenital caval occlusion and intraluminal recanalization for suspected congenital caval obstruction. A novel case is described of a young woman presenting with iliocaval DVT and phlegmasia, in which recanalization of presumed caval atresia or agenesis was accomplished using sharp recanalization with a subintimal reentry device, followed by thrombolysis, angioplasty, and stent placement to obtain caval patency and complete symptomatic relief.

A Percutaneous Crossing Algorithm for Femoropopliteal and Tibial Artery Chronic Total Occlusions (PCTO Algorithm).

Peripheral artery chronic total occlusions (PCTOs) are frequently encountered during endovascular treatment of peripheral artery disease. Failure to successfully cross PCTOs accounts for the majority of unsuccessful endovascular procedures and associated complications. This review outlines a contemporary ultrasound-based approach to crossing femoropopliteal (FP) PCTOs based on a review of prospectively collected case report surveys, published evidence, and expert opinion compiled by the writing group members. The authors describe optimal imaging of PCTO lesions as well as key angiographic and ultrasound imaging features for determining the choice of antegrade, retrograde, or hybrid techniques, initial guidewire selection, guidewire escalation, and dissection re-entry approaches. These concepts are illustrated using clearly defined hierarchical steps and case examples. The writing group members recognize that while the algorithm provided may not encompass all clinical situations, it will serve as a foundation for establishing a systematic procedural strategy for crossing PCTOs to maximize crossing efficiency, treatment success, and patient safety.

Indications for renal arteriography at the time of coronary arteriography: a science advisory from the American Heart Association Committee on Diagnostic and Interventional Cardiac Catheterization, Council on Clinical Cardiology, and the Councils on Cardiovascular Radiology and Intervention and on Kidney in Cardiovascular Disease.

Atherosclerotic renal artery stenosis is commonly present in patients with clinically manifest atherosclerosis in other vascular beds and is independently associated with increased cardiovascular morbidity and mortality. Screening tests such as renal angiography should be selectively applied to patients at high risk for renal artery stenosis who are potential candidates for revascularization. This multispecialty consensus document describes the rationale for patient selection for screening renal angiography at the time of cardiac catheterization.

Patient-Specific Simulation of Endovascular Thoracic Aortic Repair: Initial Experience.

PURPOSE: Endovascular thoracic aortic repair (TEVAR) has become the treatment modality of diverse aortic pathology. We report the use of patient-specific simulation using a dedicated PROcedure Rehearsal Studio (PRS) platform (Simbionix USA Corp, Cleveland, OH) before TEVAR and evaluate the feasibility and realism of this technology. DESCRIPTION: Virtual three-dimensional models of the patient's relevant anatomy were reconstructed from computed tomography data. PRS was used in 2 patients before TEVAR. In a multicenter retrospective study, we evaluated how PRS compares with real TEVAR. EVALUATION: PRS before TEVAR was feasible and demonstrated good correlation with the actual procedure. In the retrospective study, 16 patients were reconstructed (median duration, 26 minutes; interquartile range, 21 to 36 minutes). The realism of the simulated angiographies was rated highly (median, 4; interquartile range, 3 to 4). Final angiography revealed type I endoleak in 2 simulated cases and 1 real case. CONCLUSION: Patient-specific rehearsal before TEVAR is feasible and permits the creation of realistic case studies; however, software updates are required to improve face validity and to foster implementation in clinical practice.