2024 ACC/AHA/AACVPR/APMA/ABC/SCAI/SVM/SVN/SVS/SIR/VESS Guideline for the Management of Lower Extremity Peripheral Artery Disease: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines.

AIM: The "2024 ACC/AHA/AACVPR/APMA/ABC/SCAI/SVM/SVN/SVS/SIR/VESS Guideline for the Management of Lower Extremity Peripheral Artery Disease" provides recommendations to guide clinicians in the treatment of patients with lower extremity peripheral artery disease across its multiple clinical presentation subsets (ie, asymptomatic, chronic symptomatic, chronic limb-threatening ischemia, and acute limb ischemia). METHODS: A comprehensive literature search was conducted from October 2020 to June 2022, encompassing studies, reviews, and other evidence conducted on human subjects that was published in English from PubMed, EMBASE, the Cochrane Library, CINHL Complete, and other selected databases relevant to this guideline. Additional relevant studies, published through May 2023 during the peer review process, were also considered by the writing committee and added to the evidence tables where appropriate. STRUCTURE: Recommendations from the "2016 AHA/ACC Guideline on the Management of Patients With Lower Extremity Peripheral Artery Disease" have been updated with new evidence to guide clinicians. In addition, new recommendations addressing comprehensive care for patients with peripheral artery disease have been developed.

Developmental or Procedural Vena Cava Interruption and Venous Thromboembolism: A Review.

The inferior vena cava (IVC) and superior vena cava are the main conduits of the systemic venous circulation into the right atrium. Developmental or procedural interruptions of vena cava might predispose to stasis and deep vein thrombosis (DVT) distal to the anomaly and may impact the subsequent rate of pulmonary embolism (PE). This study aimed to review the various etiologies of developmental or procedural vena cava interruption and their impact on venous thromboembolism. A systematic search was performed in PubMed according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines per each clinical question. For management questions with no high-quality evidence and no mutual agreements between authors, Delphi methods were used. IVC agenesis is the most common form of congenital vena cava interruption, is associated with an increased risk of DVT, and should be suspected in young patients with unexpected extensive bilateral DVT. Surgical techniques for vena cava interruption (ligation, clipping, and plication) to prevent PE have been largely abandoned due to short-term procedural risks and long-term complications, although survivors of prior procedures are occasionally encountered. Vena cava filters are now the most commonly used method of procedural interruption, frequently placed in the infrarenal IVC. The most agreed-upon indication for vena cava filters is for patients with acute venous thromboembolism and coexisting contraindications to anticoagulation. Familiarity with different forms of vena cava interruption and their local and systemic adverse effects is important to minimize complications and thrombotic events.

Below-the-Knee Endovascular Revascularization: A Position Statement.

Patients with chronic limb-threatening ischemia, the terminal stage of peripheral artery disease, are frequently afflicted by below-the-knee disease. Although all patients should receive guideline-directed medical therapy, restoration of inline flow is oftentimes necessary to avoid limb loss. Proper patient selection and proficiency in endovascular techniques for below-the-knee revascularization are intended to prevent major amputation and promote wound healing. This review, a consensus among an international panel of experienced operators, provides guidance on these challenges from an endovascular perspective and offers techniques to navigate this complex disease process.

Treatment Variability Among Patients Hospitalized for Chronic Limb-Threatening Ischemia: An Analysis of the 2016 to 2018 US National Inpatient Sample.

BACKGROUND: Little is known about treatment variability across US hospitals for patients with chronic limb-threatening ischemia (CLTI). METHODS AND RESULTS: Data were collected from the 2016 to 2018 National Inpatient Sample. All patients aged ≥18 years, admitted to nonfederal US hospitals with a primary diagnosis of CLTI, were identified. Patients were classified according to their clinical presentation (rest pain, skin ulceration, or gangrene) and were further characterized according to the treatment strategy used. The primary outcome of interest was variability in CLTI treatment, as characterized by the median odds ratio. The median odds ratio is defined as the likelihood that 2 similar patients would be treated with a given modality at 1 versus another randomly selected hospital. There were 15 896 (weighted n=79 480) hospitalizations identified where CLTI was the primary diagnosis. Medical therapy alone, endovascular revascularization ± amputation, surgical revascularization ± amputation, and amputation alone were used in 4057 (25%), 5390 (34%), 3733 (24%), and 2716 (17%) patients, respectively. After adjusting for both patient- and hospital-related factors, the median odds ratio (95% CI) for medical therapy alone, endovascular revascularization ± amputation, surgical revascularization ± amputation, any revascularization, and amputation alone were 1.28 (1.19-1.38), 1.86 (1.77-1.95), 1.65 (1.55-1.74), 1.37 (1.28-1.45), and 1.42 (1.27-1.55), respectively. CONCLUSIONS: Significant variability in CLTI treatment exists across US hospitals and is not fully explained by patient or hospital characteristics.

2024 ACC/AHA/AACVPR/APMA/ABC/SCAI/SVM/SVN/SVS/SIR/VESS Guideline for the Management of Lower Extremity Peripheral Artery Disease: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines.

AIM: The "2024 ACC/AHA/AACVPR/APMA/ABC/SCAI/SVM/SVN/SVS/SIR/VESS Guideline for the Management of Lower Extremity Peripheral Artery Disease" provides recommendations to guide clinicians in the treatment of patients with lower extremity peripheral artery disease across its multiple clinical presentation subsets (ie, asymptomatic, chronic symptomatic, chronic limb-threatening ischemia, and acute limb ischemia). METHODS: A comprehensive literature search was conducted from October 2020 to June 2022, encompassing studies, reviews, and other evidence conducted on human subjects that was published in English from PubMed, EMBASE, the Cochrane Library, CINHL Complete, and other selected databases relevant to this guideline. Additional relevant studies, published through May 2023 during the peer review process, were also considered by the writing committee and added to the evidence tables where appropriate. STRUCTURE: Recommendations from the "2016 AHA/ACC Guideline on the Management of Patients With Lower Extremity Peripheral Artery Disease" have been updated with new evidence to guide clinicians. In addition, new recommendations addressing comprehensive care for patients with peripheral artery disease have been developed.

Prospective, Multicenter Registry to Assess Safety and Efficacy of Radial Access for Peripheral Artery Interventions.

Background: Radial access (RA) may offer advantages in peripheral interventions, but previous studies on this approach have been limited to retrospective or single-center studies. Our aim was to prospectively evaluate the safety and feasibility of RA for complex endovascular lower extremity interventions. Methods: In this prospective, multicenter, and observational study, eligible patients with peripheral artery disease scheduled for intervention through RA were enrolled. Primary efficacy end point was procedural success, defined as successful completion of the intended procedure without conversion to femoral access and without RA complications periprocedure. Primary safety end point included evaluation of RA-related complications at 30 days. Results: From June 2020 to June 2021, 120 patients at 8 US centers were enrolled. Mean age was 68.7 years, and 31.7% were women. The 224 lesions treated were in iliac (12.9%), femoropopliteal (55.3%), isolated popliteal (11.9%), and tibial (19.5%) vessels. The primary efficacy end point was achieved in 112 (93.3%) patients. One patient (<1%) required femoral access conversion to complete the procedure. Thirty (25.0%) patients required 1 or more additional access to facilitate crossing and/or to complete the planned treatment (5 femoral, 10 tibial, and 17 pedal accesses). No serious adverse events were adjudicated to the procedure. Mean procedure time and time to ambulation was 74 minutes and 3 hours 30 minutes; respectively, with 93.3% same-day discharge. At 30 days, 97.2% of patients recorded ultrasound-confirmed RA patency. Conclusions: This is the first prospective and multicenter registry to show the safety and efficacy of RA approach for complex endovascular lesions and multilevel disease. RA allowed early ambulation and same-day discharge with no serious adverse events. Future randomized trials should examine the clinical and cost effectiveness of this approach compared with those of femoral access for patients with peripheral artery disease.

Comparison of Large-Bore Thrombectomy With Catheter-Directed Thrombolysis for the Treatment of Pulmonary Embolism.

Background: There is significant debate on whether large-bore thrombectomy (LBT) or catheter-directed thrombolysis (CDT) is superior for the treatment of intermediate- and high-risk pulmonary embolism (PE) while employing an early invasive strategy through endovascular therapies. Methods: Between 2018 and 2021, 147 patients who presented to our institution with acute intermediate- or high-risk PE and had undergone PE Response Team-guided endovascular intervention with either LBT (Inari FlowTriever) or CDT (EKOSonic) were retrospectively reviewed. Data on the patients' clinical characteristics, comorbidities, serum biomarkers, hemodynamics, and imaging characteristics were obtained. The primary outcome was all-cause mortality; the secondary outcomes were all-cause readmission, readmission for PE, and length of stay in the intensive care unit and hospital. The safety outcome of procedure-related bleeding was evaluated. Kaplan-Meier curves were used to estimate the cumulative event rate. Multivariate Cox-proportional hazard regression and inverse propensity weighting were used to adjust for confounders. Results: The median age of the patients was 63 (IQR, 53-73) years, and 48.3% of the patients were women. Patients in the LBT group had a higher PE Severity Index score (LBT vs CDT: median, 132 vs 108; P = .015) and greater prevalence of malignancy (LBT vs CDT: median, 22.7% vs 6%; P = .011). After propensity matching for baseline characteristics, there was no significant difference in all-cause mortality (LBT vs CDT: median, 15.8% vs 9.1%; hazard ratio, 0.64; 95% CI, 0.21-1.98; P = .442) for up to 1 year. The secondary outcomes or safety end points were also similar between the 2 interventions. An exploratory analysis showed elevated PE Severity Index scores, lower systolic blood pressures, and higher lactic acid levels to be associated with an increased risk of early death at 30 days. Conclusions: In this retrospective cohort study, there was no significant difference in the cumulative event rate of all-cause mortality between LBT and CDT. Further studies are needed to evaluate the use of LBT versus CDT versus noninvasive therapy to understand outcomes and appropriate patient selection among those with intermediate- and high-risk PE.

Evaluation of an Infrapopliteal Drug-Eluting Resorbable Scaffold: Design Methodology for the LIFE-BTK Randomized Controlled Trial.

Background: Critical limb-threatening ischemia (CLTI) is a severe condition characterized by rest pain and ischemic tissue loss that affects 5% to 10% of people with peripheral artery disease. In the United States, there are few Food and Drug Administration-approved devices for the primary treatment of arteries below-the-knee (BTK). Unfortunately, all suffer from high restenosis rates due to intimal hyperplasia, elastic recoil, and untreated dissection because of a lack of scaffolding. The Esprit BTK system is a resorbable, drug-eluting scaffold device with the potential to address an unmet need in people suffering from CLTI because of infrapopliteal atherosclerosis. The LIFE-BTK (pivotaL Investigation of saFety and Efficacy of drug-eluting resorbable scaffold treatment-Below The Knee) randomized controlled trial (RCT) is a prospectively designed premarket evaluation of the Esprit BTK drug-eluting resorbable scaffold used in the treatment of those patients. Methods: The LIFE-BTK trial enrolled 261 subjects with CLTI for the RCT and a further 7 subjects for a pharmacokinetic substudy. The objective of the RCT was to evaluate the safety and efficacy of the Esprit BTK scaffold compared to percutaneous transluminal angioplasty. The primary efficacy end point was a composite of limb salvage and primary patency at 12 months. The primary safety end point is freedom from major adverse limb events and peri-operative death at 6 months and 30 days, respectively. Clinical follow-up care is planned for 5 years. Conclusions: Novel devices must be tested in RCTs to evaluate their safety and efficacy compared to the standard of care if we are to improve outcomes for this challenging group of patients.

Atherectomy Plus Balloon Angioplasty for Femoropopliteal Disease Compared to Balloon Angioplasty Alone: A Systematic Review and Meta-analysis.

Background: The role of atherectomy in treating femoropopliteal disease has been evolving rapidly. However, the clinical efficacy and safety of adjunctive atherectomy to percutaneous balloon angioplasty (BA) (plain balloon and drug-coated BA) remains controversial. We sought to perform a meta-analysis comparing atherectomy plus balloon angioplasty (ABA) versus BA alone in treating femoropopliteal disease. Methods: We searched PubMed, Cochrane Central Register of Clinical Trials, EMBASE, and ClinicalTrials.gov (from inception through January 10, 2022) for studies comparing ABA versus BA for femoropopliteal disease. We used a random-effects model to calculate risk ratio (RR) with 95% CIs. Target lesion revascularization (TLR), primary patency, and bailout stenting were the primary outcomes. Results: Nine studies with 699 patients were included (4 randomized and 5 retrospective studies). Compared to BA alone, the ABA group showed a significant decrease in TLR driven by nonrandomized studies (RR 0.59; 95% CI, 0.40-0.85; P = .005) and bailout stenting (RR, 0.32; 95% CI, 0.21-0.48; P < .0001). There was no significant difference in TLR when the analysis was performed including only randomized trials. There was no significant difference in the primary patency between the 2 groups (RR, 1.04; 95% CI, 0.95-1.14; P = .37). Conclusions: Data from randomized trials suggest that compared with BA alone, the combination of atherectomy and BA showed no difference in TLR or primary patency. In observational studies, TLR and bailout stenting were reduced in ABA group but there was no difference in primary patency. Further studies are needed to investigate the clinical outcomes of atherectomy combined with BA in femoropopliteal lesions compared with BA alone.