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).

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.

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.

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.

Optimal use of atherectomy in critical limb ischemia.

Critical limb ischemia (CLI) is the most severe and debilitating form of peripheral arterial disease and is associated with high rates of limb loss and cardiovascular mortality. The unique physical environment of tibial occlusive disease underlying most CLI cases limits treatment options and long-term durability, with resulting frequent rates of persistent obstruction, restenosis, and reintervention. Atherectomy represents a potential strategy to improve acute and late results when treating patients with CLI. Available atherectomy devices each have specific performance characteristics, evidentiary rationale, and limitations that mandate a clear understanding of the optimal albeit evolving use of this category of interventional tools.

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.

Transarterial chemoembolization for primary hepatocellular carcinoma in patients at high risk.

PURPOSE: Transarterial chemoembolization (TACE) has become a standard treatment option for patients with unresectable hepatocellular carcinoma (HCC). This retrospective study evaluated the safety and efficacy of TACE in patients at high risk with increased serum bilirubin level, low serum albumin level, poor hepatic reserve, or compromised hepatopetal flow in the portal vein (PV). MATERIALS AND METHODS: A total of 52 patients underwent 65 high-risk procedures. Thirty patients treated with 38 procedures (57.7% of patients and 58.5% of procedures) had serum bilirubin levels of 2-3 mg/dL (ie, moderate elevation) and 22 patients treated with 27 procedures (42.3% and 41.5%) had a serum bilirubin level of at least 3 mg/dL (ie, considerable elevation). Forty patients (76.9%) had serum albumin levels less than 3.5 mg/dL. Thirteen recipients of 15 procedures (25% and 20%) had portal diversion or obstruction. Twenty-four patients (46.2%) had a Child-Pugh (CP) score of 8 or less and 28 patients (53.8%) had a CP score of at least 9 at the time of TACE. Thirty patients (57.7%) had focal tumors and 22 patients (42.3%) had multifocal or infiltrative disease. Superselective chemoembolization could be performed in 37 procedures (56.9%); lobar chemoembolization was performed in the remaining 28 (43.1%). RESULTS: The 30-day mortality rate was 7.7% and the procedure-related morbidity rate was 10.8%. Patients with multifocal disease and lobar embolization had significantly higher mortality rates (P=.03). Individual factors such as serum bilirubin, serum albumin, and PV flow did not affect outcomes significantly. The 1- and 2-year survival rates in patients with focal disease were 67.9% and 37.7%, respectively, compared with 19.6% and 0% in patients with multifocal disease (P<.0001). CONCLUSIONS: TACE in patients considered at high risk does not necessarily incur a higher incidence of morbidity or mortality. Patient selection should be based on extent of disease, and these tumors should be treated selectively at a segmental level if possible.

Regulatory approval of peripheral endovascular revascularization devices in the United States: is the horse still in the barn?

The regulatory processes by which industry obtains approval for marketing and sales of medical devices from the United States Food and Drug Administration is distinct from the drug approval pathways, poorly understood by clinicians, and widely criticized by clinical investigators and industrial sponsors of new technology. This paper reviews the most common pathways for obtaining such approval for endovascular devices used in the treatment of peripheral arterial disease. Unique issues pertinent to clinical trials carried out in this area are highlighted. Future directions for evolution of the regulatory process consonant with the mandated requirements for demonstration of safety and efficacy are discussed.

Drug-eluting stents: potential applications for peripheral arterial occlusive disease.

Many different approaches have been evaluated to prevent restenosis in stents after vascular implantation. Currently, drug-eluting stents are extremely promising in suppressing neointimal hyperplasia. Various animal studies and randomized trials in humans have shown excellent results in terms of safety and efficacy during intermediate-term follow-up. This article will give an overview of experimental and clinical data of the different agents in published and ongoing trials.