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.

Sex disparities in popliteal artery aneurysms.

OBJECTIVE: Only 5% of patients with popliteal artery aneurysms (PAAs) are female. Evidence on PAA treatment and outcomes in women is therefore scarce. The POPART Registry provides one of Europe's largest data collections regarding PAA treatment. Data on clinical presentation, aneurysm morphology, and perioperative outcomes after open surgical PAA repair in women will be presented. METHODS: POPART is a multicenter, noninterventional registry for open and endovascular PAA repair, with 42 participating centers in Germany and Luxembourg. All patients aged >18 years who have been treated for PAA since 2010 are eligible for study inclusion. Data collection is based on an online electronic case report form. RESULTS: Of the 1236 PAAs, 58 (4.8%) were in women. There were no significant differences in age or cardiopulmonary comorbidities. However, female patients had a lower prevalence of contralateral PAAs and abdominal aortic aneurysms (P < .05). PAAs in women were more likely to be symptomatic before surgery (65.5% vs 49.4%; P = .017), with 19% of women presenting with acute limb ischemia (vs 11%; P = .067). Women had smaller aneurysm diameters than men (22.5 mm vs 27 mm; P = .004) and became symptomatic at smaller diameters (20 mm vs 26 mm; P = .002). Only 8.6% of women and 11.6% of men underwent endovascular aneurysm repair (P > .05); therefore, the perioperative outcome analysis focused on open surgical repair. In total, 23.5% of women and 16.9% of men developed perioperative complications (P > .05). There were no differences in major cardiovascular events (P > .05), but women showed a higher incidence of impaired wound healing (15.7% vs 7.2%; P = .05) and major amputation (5.9% vs 1.1%; P = .027). Female sex was significantly associated with the need for nonvascular reinterventions within 30 days after surgery (odds ratio: 2.48, 95% confidence interval: 1.26-4.88), whereas no significant differences in the odds for vascular reinterventions were observed (odds ratio: 1.98, 95% confidence interval: 0.68-5.77). In the multiple logistic regression model, female sex, symptomatic PAAs, poor quality of outflow vessels, and graft material other than vein graft were independently associated with perioperative reinterventions. CONCLUSIONS: Women have smaller PAAs, are more likely to be symptomatic before treatment, and are more often affected by nonvascular reinterventions in the perioperative course. As our understanding of aneurysmatic diseases in women continues to expand, sex-specific treatment strategies and screening options for women in well-selected cohorts with modified screening protocols should be continuously re-evaluated.

Percutaneous thrombectomy for acute limb ischemia is associated with equivalent limb and mortality outcomes compared with open thrombectomy.

BACKGROUND: Acute limb ischemia (ALI) carries a 15% to 20% risk of combined death or amputation at 30 days and 50% to 60% at 1 year. Percutaneous mechanical thrombectomy (PT) is an emerging minimally invasive alternative to open thrombectomy (OT). However, ALI thrombectomy cases are omitted from most quality databases, limiting comparisons of limb and survival outcomes between PT and OT. Therefore, our aim was to compare in-hospital outcomes between PT and OT using the National Inpatient Sample. METHODS: We analyzed survey-weighted National Inpatient Sample data (2015-2020) to include emergent admissions of aged adults (50+ years) with a primary diagnosis of lower extremity ALI undergoing index procedures within 2 days of hospitalization. We excluded hospitalizations with concurrent trauma or dissection diagnoses and index procedures using catheter-directed thrombolysis. Our primary outcome was composite in-hospital major amputation or death. Secondary outcomes included in-hospital major amputation, death, in-hospital reintervention (including angioplasty/stent, thrombolysis, PT, OT, or bypass), and extended length of stay (eLOS; defined as LOS >75th percentile). Adjusted odds ratios (aORs) with 95% confidence intervals (95% CIs) were generated by multivariable logistic regression, adjusting for demographics, frailty (Risk Analysis Index), secondary diagnoses including atrial fibrillation and peripheral artery disease, hospital characteristics, and index procedure data including the anatomic thrombectomy level and fasciotomy. A priori subgroup analyses were performed using interaction terms. RESULTS: We included 23,795 survey-weighted ALI hospitalizations (mean age: 72.2 years, 50.4% female, 79.2% White, and 22.3% frail), with 7335 (30.8%) undergoing PT. Hospitalization characteristics for PT vs OT differed by atrial fibrillation (28.7% vs 36.5%, P < .0001), frequency of intervention at the femoropopliteal level (86.2% vs 88.8%, P = .009), and fasciotomy (4.8% vs 6.9%, P = .006). In total, 2530 (10.6%) underwent major amputation or died. Unadjusted (10.1% vs 10.9%, P = .43) and adjusted (aOR = 0.96 [95% CI, 0.77-1.20], P = .74) risk did not differ between the groups. PT was associated with increased odds of reintervention (aOR = 2.10 [95% CI, 1.72-2.56], P < .0001) when compared with OT, but this was not seen in the tibial subgroup (aOR = 1.31 [95% CI, 0.86-2.01], P = .21, Pinteraction < .0001). Further, 79.1% of PT hospitalizations undergoing reintervention were salvaged with endovascular therapy. Lastly, PT was associated with significantly decreased odds of eLOS (aOR = 0.80 [95% CI, 0.69-0.94], P = .005). CONCLUSIONS: PT was associated with comparable in-hospital limb salvage and mortality rates compared with OT. Despite an increased risk of reintervention, most PT reinterventions avoided open surgery, and PT was associated with a decreased risk of eLOS. Thus, PT may be an appropriate alternative to OT in appropriately selected patients.

Multilevel thrombotic or embolic burden and its role in sex-related outcomes in acute limb ischemia.

OBJECTIVE: The impact of sex upon outcomes in acute limb ischemia (ALI) remains disputed. We aim to quantify the effect of sex upon amputation-free survival (AFS) after a percutaneous-first approach for ALI. METHODS: This was a two-center retrospective review of ALI managed via a percutaneous-first approach. Demographics, comorbidities, and clinical characteristics were analyzed. The Kaplan-Meier and Cox regression were used to estimate AFS, limb salvage, and overall survival. RESULTS: Over 9 years, 170 patients (n = 87, 51% males; median age, 67 [interquartile range (IQR), 59-77 years) presented with ALI. Rutherford classification was I in 56 (33%); IIa in 85 (50%); IIb in 20 (12%), and III in 9 (5%). Thirty-day mortality, major amputation rate, and fasciotomy rates were 8% (n = 13); 6.5% (n = 11), and 4.7% (n = 8), respectively. Among revascularized limbs, 92% were patent at 30 days. Length of stay was 7 days (IQR, 3-11 days). Complications included 13 bleeding episodes (8%), four cases of atrial fibrillation (2%), and three re-thrombosis/clot extension events (1.7%). No differences were noted in complication rates when stratified by sex. Females were older than males (median age, 70 [IQR, 62-79] vs 65 [IQR, 56-76 years]; P = .02) and more likely to present with atrial fibrillation (20.5% vs 8%; P = .02) and hyperlipidemia (72% vs 57%; P = .04). Females also more frequently presented with multi-level thrombotic/embolic burden compared with males (56% vs 43%; P = .03) and required both aspiration thrombectomy and thrombolysis (27% vs 14%; P = .02). Kaplan-Meier estimated median AFS, limb salvage, and overall survival were 425 days (IQR, 140-824 days); 314 days (IQR, 72-727 days); and 342 days (IQR, 112-762 days). When stratified by sex, females had worse survival (median, 270 days [IQR, 92-636 days] vs 406 days [IQR, 140-937 days]; P = .005) and limb salvage (median, 241 days [IQR, 88-636 days] vs 363 days [IQR, 49-822 days]; P = .04) compared with males. Univariate Cox regression showed female sex (hazard ratio [HR], 1.46; 95% confidence interval [CI], 1.04-2.05; P = .03), multi-level thrombotic/embolic burden (HR, 1.64; 95% CI, 1.17-2.31; P = .004), and Rutherford class (HR, 1.37; 95% CI, 1.08-1.73; P = .009) predicted major amputation/death. By multivariable Cox regression, multi-level thrombotic/embolic burden (HR, 1.54; 95% CI, 1.09-2.17; P = .01), Rutherford class (HR, 1.34; 95% CI, 1.07-1.69; P = .01), and female sex (HR, 1.45; 95% CI, 1.03-2.05; P = .03) were each independently predictive of major amputation/death. CONCLUSIONS: A percutaneous-first strategy is safe and efficacious in the overall ALI population. Similar to prior works, female vs male patients with ALI in our cohort have higher rates of mortality and major amputation. In our multivariable model, multi-level thrombotic/embolic burden was independently associated with a greater than 45% increased hazard of major amputation/death at last follow-up. Further prospective analysis is warranted to elucidate the underlying factors contributing to the higher prevalence of multi-level thrombotic/embolic burden in female patients with ALI, and to further define the optimal percutaneous-first approach for ALI in consideration of patient sex and extent of clot burden.

Occurrence, predictors, and management of late vascular complications following extracorporeal membrane oxygenation.

OBJECTIVE: Vascular complications (VCs) associated with extracorporeal membrane oxygenation (ECMO) during index hospitalization are prevalent and associated with increased mortality. Few studies have evaluated late VCs following ECMO; this study aims to assess occurrence and management practices of late VCs following discharge. METHODS: A retrospective single-institution review was performed of all patients surviving initial hospitalization after being cannulated for central or peripheral veno-venous (VV) or veno-arterial (VA) ECMO between January 1, 2019, and December 31, 2020. Primary outcomes were to categorize and determine the rate of late VCs. Late VCs were defined as any cannulated vessel injury resulting from ECMO cannulation presenting after discharge from index hospitalization. Analysis was conducted by cannulated vessel and stratified by VV or VA ECMO configurations. RESULTS: A total of 229 patients were identified, of which 50.6% (n = 116) survived until discharge. Late VCs occurred in 7.8% of the surviving cohort (n = 9/116); with a median time until presentation of 150 days (interquartile range, 83-251 days). The most common late VC was infection (n = 5; 55.6%) followed by progression to limb-threatening ischemia (n = 4; 44.4%). Urgent procedures were required in 55.6% of patients (n = 5), whereas 44.4% (n = 4) were elective interventions. Interventions performed for management of late VCs included lower extremity arterial revascularization (n = 6; 66.7%), major (n = 1; 11.1%) or minor amputation (n = 1; 11.1%), and wound debridement (n = 1; 11.1%). The majority of patients presenting with late VCs had initially been cannulated for peripheral VA ECMO (n = 8; 88.9%), and one patient (11.1%) was cannulated for peripheral VV ECMO. VCs during index hospitalization were seen in 77.8% of patients (n = 7) returning with late VCs. Odds for late VCs were significantly increased in patients that had been cannulated for ECMO as part of extracorporeal cardiopulmonary resuscitation (odds ratio, 8.4; P = .016) and in cases where patients had experienced an index VC during index hospitalization (odds ratio, 19.3; P = .001). CONCLUSIONS: Late vascular complications after peripheral ECMO cannulation are not rare, particularly after arterial cannulation. Patients should be followed closely early after surviving ECMO with wound evaluation and formal assessment of perfusion with ankle-branchial indices in the cannulated limb.

Single-center experience with the JETi Hydrodynamic Thrombectomy System for acute limb ischemia.

OBJECTIVE: Acute limb ischemia (ALI) remains a vascular emergency with high morbidity and mortality. While the JETi Hydrodynamic Thrombectomy System (Abbott) offers a percutaneous approach to fragment and aspirate the thrombus in patients with arterial occlusions, data on its efficacy and safety are limited. This study reports our early experience using the JETi device to treat ALI at our institution. METHODS: This is a single-center, retrospective review of patients with ALI treated with the JETi device between September 2020 and December 2022. Patients were included if the JETi device was used either as a primary intervention or as an adjunct procedure. The primary endpoint was technical success defined as <50% residual thrombus after intervention. Secondary endpoints included achieving complete resolution of the thrombus on angiogram, acute kidney injury (AKI), major bleeding, 30-day major amputation, and 30-day mortality. RESULTS: A total of 59 JETi procedures for ALI (median age 62 years [interquartile range: 56-71 years]) were performed on 39 male and 20 female patients. The median time from onset of symptoms to hospitalization was 24 hours (interquartile range: 4-168 hours). Rutherford classifications were I (10), IIa (27), IIb (14), and undocumented (8). Etiology of ALI was native vessel thrombosis (27), embolism (16), graft/stent thrombosis (14), and iatrogenic (2). A total of 124 vessels were treated, with an average of 2.1 vessels per procedure. The primary outcome was achieved in 86% (107/124) of the arteries, with 82% (102/124) successfully opened using the JETi device alone without the need for any adjunctive therapy. Complete resolution of the thrombus using JETi was achieved in 81% (101/124) arteries, with or without the use of adjunctive therapy. A total of 6.7% (4/59) patients required a major limb amputation within 30 days despite successful recanalization, and one 30-day mortality was recorded. Complications included distal embolization (5), access site hematoma (2), and AKI (4). No major bleeding, hemolysis-induced AKI, or vessel dissection or perforation was observed. CONCLUSIONS: The JETi device appears to be a safe and effective percutaneous treatment option in the management of ALI. It provides definitive treatment with a high technical success rate of 86% and a good safety profile.

Retrieval of n-Butyl Cyanoacrylate Cast Migrated to the Dorsalis Pedis and Posterior Tibial Artery During Embolization of the Deep Circumflex Iliac Artery Using the Stent Retriever Device: A Case Report.

CLINICAL IMPACT: This case highlights the innovative application of stent retriever devices for retrieving migrated NBCA casts, traditionally used for stroke management in peripheral arterial occlusions. This adaptation offers clinicians a new, effective tool for managing embolization complications, such as unintended material migration that can cause severe ischemia. Implementing this technique could change clinical practice by providing a reliable method to swiftly address and resolve potentially limb-threatening situations, thereby improving patient outcomes and procedural safety. This advancement in interventional radiology enhances clinicians' ability to handle complex embolic events with greater confidence and efficacy.

Paradigm Shift of Interventional Strategies and Outcomes for Acute Limb Ischemia Post-Pandemic.

PURPOSE: We performed a large-scale comparison of patients treated for acute limb ischemia (ALI) in the pre-COVID (2017-2019) and COVID (2020-2022) eras to evaluate changes in interventional strategies and compare factors associated with adverse outcomes. We sought to characterize patient outcomes in an evolving ALI treatment algorithm in response to pandemic-associated presentation delays and rapid technological advancements in mechanical thrombectomy (MT). METHODS: Using the TriNetX global research network, we conducted a multicenter query across 80 health care organizations (HCOs) spanning 4 countries for patients treated for ALI. Propensity score matching was performed to account for comorbidities. Risk of adverse outcomes within 30 days was calculated for each era, including re-intervention (RI30), major/minor amputation, and death. Patients were then stratified by initial intervention: open revascularization (OR), MT, or catheter-directed thrombolysis and adjunctive endovascular procedures alone (CDT/EP). Risk of adverse outcomes was compared between treatment groups of the same era. RESULTS: After propensity score matching, the pre-COVID era and COVID era cohorts included 7344 patients each. COVID era patients experienced a statistically significant higher risk of 30-day mortality (RR=1.211, p=0.027). Mechanical thrombectomy interventions were performed more frequently in the COVID era (RR=1.314, p<0.0001). Comparing outcomes between treatment groups, MT patients required RI30 more than OR patients (pre-COVID: RR=2.074, p=0.006; COVID: RR=1.600, p=0.025). Open revascularization patients had higher 30-day mortality (pre-COVID: RR=2.368, p<0.0001; COVID: RR=2.013, p<0.0001) and major amputations (pre-COVID: RR=2.432, p<0.0001; COVID: RR=2.176, p<0.0001) than CDT/EP. Pre-COVID CDT/EP patients were at higher risk for RI30 (RR=1.449, p=0.005) and minor amputations (RR=1.500, p=0.010) than OR. The MT group had higher major amputation rates than CDT/EP (pre-COVID: RR=2.043, p=0.019; COVID: RR=1.914, p=0.007). COVID-era MT patients had greater 30-day mortality (RR=1.706, p=0.031) and RI30 (RR=1.544, p=0.029) than CDT/EP. CONCLUSION: Significant shifts toward an MT-based approach have been observed in the last 3 years. Although MT required more RI30 than OR, there was no associated consequence of mortality and limb salvage. The increased mortality seen among COVID-era patients could be explained by delayed presentation, as well as poorly understood pro-thrombogenic or pro-inflammatory mechanisms related to the first waves of COVID. More research is necessary to determine an optimal treatment algorithm. CLINICAL IMPACT: Comorbid risk factors and severity of ischemia must be carefully considered before selecting an interventional strategy to prevent adverse outcomes and maximize limb salvage. Open revascularization strategies are associated with increased mortality and limb loss compared to less-invasive thrombolytic therapy alone. Mechanical thrombectomy (MT)-based approaches have been increasingly used in the last 3 years. Patients receiving MT are more likely to require reintervention within 30 days.

A Free-Floating Aortic Thrombus: An Uncommon Approach to Handle a Rare Clinical Entity.

BACKGROUND: Thrombotic material in the non-aneurysmatic and non-atherosclerotic aorta is a rare entity without any recommended standard treatment so far. We present a successful treatment strategy for patients who do not fit into any of the common approaches. CASE REPORT: A free-floating thrombus in the descending aorta was found as source of embolism in an 82-year-old female patient with lower limb ischemia. After initial heparinization of the patient without relevant reduction of the thrombotic mass, the thrombus was removed using an interdisciplinary approach. Under echocardiographic guidance to locate the thrombus, the AngioVac device, usually licensed to remove floating thrombi from the venous system, was used off-label to remove the thrombus by a transfemoral approach. To avoid rebuilding of a new thrombus, the attachment point with an exulcerated plaque in the descending aorta was covered by a stent graft via the same femoral access. The patient did not experience any further embolic events, and the postoperative course was uncomplicated. CONCLUSION: Patients with uncommon aortic diseases, such as the reported free-floating thrombus, should be treated by an individualized, interdisciplinary approach. Besides the recommended treatment options, there are other uncommon approaches that might offer an alternative in complex cases. CLINICAL IMPACT: Evidence is rare for the treatment of a free-floating thrombus in the descending aorta and the treatment strategy remains discussed controversially. We present a rather uncommon approach of successful off-label treatment for patients who do not fit into any of the common approaches (operative, endovascular, or conservative treatment based on patient's comorbidities). The AngioVac System has already been successfully used off-label in the arterial system but not in the above presented way of treating a free-floating thrombus in a patient with high embolization risk and treatment-limiting comorbidities.

Mid-term Outcomes of Image-Guided Surgical Thromboembolectomy and Routine Intraoperative Angiography for Native Vessel Acute Lower-Limb-Threatening Ischemia.

BACKGROUND: Standard balloon-catheter thromboembolectomy (TE) is an established effective treatment for acute lower-limb ischemia (ALI) with recognized limitations when there is an underlying arterial lesion or thromboembolism of the infrapopliteal arteries. The aim of this study was to evaluate the efficacy and safety of image-guided surgical TE combined with routine intraoperative completion angiography in the treatment of ALI patients. METHODS: Between September 2020 and August 2022, this prospective study included all consecutive adult patients presenting to a tertiary center with unilateral ALI of Rutherford class II due to thromboembolic occlusion of native arteries who underwent image-guided surgical TE and routine completion intraoperative angiography. Adjunctive endovascular techniques (hybrid revascularization) including plain balloon angioplasty (PTA)±stenting or on-table lysis were used if underlying arterial lesions or residual thrombosis were detected on the intraoperative angiography, respectively. The primary outcome measures included technical success and 30-day major amputation rate. Perioperative complications, 1-year primary and secondary patency, limb salvage, mortality, and amputation-free survival rates were endorsed as secondary outcome measures. RESULTS: Image-guided surgical thrombectomy was done for 109 ALI patients (109 limbs), provisionally diagnosed as embolic (57 patients, 52.3%) or thrombotic (52 patients, 47.7%) arterial occlusion. Thromboembolectomy without adjunctive endovascular treatment was done in 38 patients (34.86%), whereas 71 patients (65.14%) required adjunctive PTA±stenting of underlying arterial lesions (60, 55.05%) or on-table lysis±PTA of residual thrombosis (11, 10.09%). The overall technical success rate was 92.66%. At 30 days, amputation and mortality rates were 3.67% and 5.5%, respectively. None of the patients had thrombectomy-induced arterial injuries. One-year follow-up data were available for 81 patients (74.3%). The Kaplan-Meier estimate of the 12-month primary and secondary patency, limb salvage, and amputation-free survival rates was 76.5%±0.04, 91.5%±0.03, 90.6±0.03, and 91.4±0.03%, respectively. CONCLUSIONS: Image-guided TE combined with routine intraoperative angiography is a safe and effective technique for surgical TE in acute lower-limb ischemia patients with the advantage of immediate identification and treatment of underlying arterial lesions or residual thrombosis for optimal revascularization. CLINICAL IMPACT: The present study has confirmed the safety and effectiveness of image-guided thromboembolectomy combined with routine use of intraoperative angiography during surgical treatment of acute lower limb ischemia in terms of immediate identification and treatment of underlying arterial lesions or residual thrombosis for optimal revascularization. This technique also facilitates selective passage of Fogarty balloon catheter into infrapopliteal arteries from the femoral approach which is traditionally done by exploration of the popliteal trifurcation or tibial arteries under regional or general anesthesia. Using this technique can guide the operating surgeon for adequate balloon manipulation and inflation to avoid iatrogenic vessel injury.

One-Year Clinical Outcomes and Prognostic Factors Following Revascularization in Patients With Acute Limb Ischemia　- Results From the RESCUE ALI Study.

BACKGROUND: Acute limb ischemia (ALI) is a limb- and life-threatening condition and urgent treatment including revascularization should be offered to patients unless the limb is irreversibly ischemic. The aim of this study was to investigate 1-year clinical outcomes and prognostic factors following revascularization in patients with ALI.Methods and Results: A retrospective, multicenter, nonrandomized study examined 185 consecutive patients with ALI treated by surgical revascularization (SR), endovascular revascularization (ER), or hybrid revascularization (HR) in 6 Japanese medical centers from January 2015 to August 2021. The 1-year amputation-free survival (AFS) rate was estimated to be 69.2% (95% confidence interval [CI], 62.8-76.2%). There were no significant differences among SR, ER, and HR regarding both technical success and perioperative complications. Multivariate analysis revealed that Rutherford category IIb and III ischemia (hazard ratio [HR]: 1.86; 95% CI: 1.06-3.25), supra- to infrapopliteal lesion (HR: 2.06; 95% CI: 1.08-3.95), and technical failure (HR: 2.58; 95% CI: 1.49-4.46) were independent risk factors for 1-year AFS. CONCLUSIONS: Rutherford category IIb and III ischemia, supra- to infrapopliteal lesions, and technical failures were identified as independent risk factors for 1-year AFS. Furthermore, patients with multiple risk factors had a lower AFS rate.

Five-year outcomes of the GORE VIABAHN Endoprosthesis for the treatment of complex femoropopliteal lesions from a Japanese postmarket surveillance study.

Introduction: The safety and effectiveness of the GORE VIABAHN Endoprosthesis for treatment of symptomatic patients with peripheral artery disease (PAD) and complex femoropopliteal (FP) lesions was assessed in a real-world Japanese practice setting. Methods: A prospective, multicenter, postmarket surveillance study was conducted from 2016 to 2017 at 64 sites in Japan. Symptomatic patients with PAD and FP lesions ⩾ 10 cm and reference vessel diameters ranging from 4.0 to 7.5 mm were eligible for enrollment. Outcome measures evaluated at 5 years were primary patency (PP), primary-assisted patency (PAP), secondary patency (SP), freedom from target lesion revascularization (fTLR), occurrence of device- or procedure-related serious adverse events (SAEs), and stent fractures. Results: A total of 321 patients were enrolled and were a mean age of 73.9 ± 8.7 years; 77.3% were men and 26.5% had chronic limb-threatening ischemia (CLTI). The mean lesion length was 23.6 ± 6.6 cm and the frequency with TASC II C/D lesions and chronic total occlusions was 86.6% and 70.4%, respectively. The Kaplan-Meier estimated PP, PAP, SP, and fTLR at 5 years was 62.4%, 74.1%, 82.3%, and 75.9%, respectively. The mean ankle-brachial index was 0.92 ± 0.15 and the mean improvement in Rutherford class was 2.3 ± 1.4, which was maintained through 5 years. The rate of cumulative device- or procedure-related SAEs through 5 years was 19.9% with only 9.3% of those occurring after the first year. No stent fractures were observed through 5 years by x-ray evaluation. Conclusion: The 5-year safety and efficacy outcomes of the endoprosthesis were clinically acceptable for treating complex FP lesions in a real-world cohort of Japanese patients with PAD. (ClinicalTrials.gov Identifier: NCT04706273).

Acute limb ischemia in nonagenarians: Characteristics and factors related to outcomes in a single-center consecutive series.

BACKGROUND: The increasing aging and frailty of the population make the management of acute limb ischemia (ALI) more difficult, with decision-making far from being guided by evidence. The aim of the study was to evaluate the characteristics and results of ALI treatment in nonagenarians. MATERIALS AND METHODS: Retrospective analysis of a consecutive series of nonagenarian patients with ALI attended at our institution between 2008 and 2021. The primary outcomes of the study were 1-year limb salvage and survival rates. RESULTS: A total of 102 patients were included (mean age 92.38, 78.4% women). In 83 cases (81.4%) ALI was attributed to embolism, and 19 (18.6%) to acute arterial thrombosis. One-month overall survival was 70.6%. Fifteen patients (14.7%) were treated palliatively, including 8 (53.3%) irreversible ALI with associated malignancy/advanced dementia, 5 (33.3%) with associated cerebral/intestinal ischemia and 2 (13.3%) with aortic occlusion and poor medical condition. None of these patients survived after 10 days. The remaining 87 patients (85.3%) were treated with isolated anticoagulation (n = 8, 9.1%), primary major amputation (n = 1, 1.1%) or revascularization (n = 78, 89.6%), including 69 (67.6%) embolectomies, 6 (5.9%) bypass and 3 (2.9%) endovascular techniques. One-year limb salvage and survival rates were 96% and 48%, respectively. Predictive factors of lower survival included anemia (HR = 1.81, p = 0.014) and ALI severity (HR = 1.73, p = 0.032), but not cognitive or functional status. Patients surviving the ALI episode had a 1-year survival rate significantly below that of a similar matched population. CONCLUSION: Although nonagenarians with an ALI are often functionally and cognitively impaired and have a limited life expectancy, most patients need revascularization for limb salvage and this can be done successfully with a low invasive surgery.

Quality of Life Predictors in Patients with Acute Lower Limb Ischemia Quality of Life in Acute Limb Ischemia.

OBJECTIVE: While existing literature has established factors associated with improved health-related quality of life (HRQOL) in patients with chronic limb-threatening ischemia, similar work has not been done in individuals with acute lower limb ischemia (ALLI). This study aims to identify the factors associated with HRQOL in patients presenting with ALLI. METHODS: Using a prospectively collected registry, all patients who received treatment for ALLI between May 2016 and July 2023 at a quaternary medical center were identified and invited to complete two HRQOL questionnaires: the VascuQoL-6 and the EQ-5D-5L. Simple linear regression followed by multivariate analysis using multiple linear regression were used to determine the patient variables independently associated with HRQOL. RESULTS: Of the 216 eligible patients treated for ALLI during the study period, 47 (20%) of patients with a mean age of 58 ± 10 years completed the HRQOL questionnaires. Questionnaires were completed at a median time of 16.5 months after the episode of ALLI. On multiple linear regression, higher age was associated with higher VascuQoL-6 (p=0.037) and EQ-5D-5L (p=0.041) scores, while hypertension and non-ambulatory status were significant predictors of lower VascuQoL-6 (p=0.006, p=0.013) and EQ-5D-5L (p=0.009, p=0.026) scores. Any ambulation had a significantly higher HRQOL compared to non-ambulatory status, but no significant HRQOL difference was observed between patients with any type of ambulation (unhindered ambulation, ambulation with pain, and ambulation using a prosthesis). CONCLUSION: This study demonstrates that the ability to ambulate after ALLI, and not amputation per se, is an important predictor of HRQOL. As such, early rehabilitation strategies should be a focus of post-ALLI care. Further exploration of factors that shape HRQOL after ALLI is needed.

Clinical value of foot thermometry in patients with acute limb ischemia.

OBJECTIVE: We hypothesized that the severity of foot poikilothermy can be used for better differentiation of grades of acute limb ischemia. Thus, the study aim was evaluation of the value of non-contact foot thermometry, performed using a low-cost infrared medical thermometer, as an adjunct for clinical diagnosis of immediately threatened acute limb ischemia. METHODS: It was a single-center observational prospective study performed over 3 years. Patients with acute limb ischemia of lower limbs grade I-IIB Rutherford treated with urgent revascularization were included. Grade of ischemia was determined independently by two experienced vascular surgeons. Thermometry of the ischemic foot was performed using a medical digital infrared non-contact thermometer (CK-T1501, Cooligg, China) with measuring accuracy of ±0.2°C. Temperature was measured in three points: the dorsal surface of the foot, plantar surface of the foot (both in the metatarsal region), and forehead. The maximal temperature gradient between patient's forehead and foot (∆Tmax F-F) was calculated. Measurements were repeated 6-12 h after revascularization. RESULTS: A total of 147 patients were included. Only 3 (2%) patients presented rest pain without sensory loss and motor deficit, while the majority were diagnosed with mild (63/147, 42.8%) or moderate (27/147, 18.3%) motor deficit. The temperature of the ischemic foot varied from 20 to 36.1°C, while median value of the temperature was 26.7 [24.5-29.9] °C on the dorsal surface and 26.8 [24.5-29.6] °C on the plantar surface of the foot (p = 0.85). Patients with Grade IIB ischemia had significantly lower dorsal foot temperature, plantar foot temperature, and larger ∆Tmax F-F than the patients with grades I-IIA: 25.1 [23.9-26.8] °C versus 29.9 [27.6-30.8] °C; 25.2 [23.8-27.5] °C versus 29.6 [28-31.1] °C; and 11.6 [9.7-12.8] °C versus 7.2 [6-9] °C (p < 0.0001). Areas under ROC curve for diagnosis of Grade IIB ischemia were similar for dorsal foot temperature (0.82), plantar temperature (0.81), and ∆Tmax F-F (0.82). The best cutoff value by Youden was ≥9.5°C for ∆Tmax F-F, ≤26.8°C for dorsal, and ≤27.7°C for plantar temperature. Criterion ∆Tmax F-F offered the highest specificity of 86% (95%CI 74.2-93.7) and positive predictive value of 89.2% (95%CI 79.5-93.2), while plantar temperature offered sensitivity of 82.5% (95%CI 70.1-91.3) and negative predictive value of 69.1% (95%CI 57.6-83.2). In multivariate analysis including age, gender, and etiology of arterial occlusion, the criterion ∆Tmax F-F of ≥9.5°C was a unique variable significantly associated with risk of amputation (adjusted OR 2.6, 95%CI 1.2-5.9, p = 0.01). CONCLUSION: Current study demonstrated that patients with immediately threatening ALI have significantly lower foot temperature than those with viable and marginally threatened limbs. Severe foot poikilothermy at admission is associated with poor outcomes of revascularization, mostly with limb loss.

Contraindications to tissue plasminogen activator thrombolysis for acute lower extremity ischemia.

OBJECTIVE: Previous randomized prospective trials have demonstrated the effectiveness of transcatheter tissue plasminogen activator (tPA) thrombolysis in treating acute limb ischemia (ALI) compared to conventional surgery. These pivotal trials have also highlighted contraindications for these procedures. Given recent advancements in techniques and technology, our aim is to reassess the relevance of these contraindications in contemporary practice. METHODS: A retrospective chart analysis was performed utilizing the inpatient medical records of consecutive individuals who underwent tPA treatment for acute limb ischemia (ALI) from September 2016 to April 2022. Inclusion criteria encompassed patients aged 18 and above displaying clinical symptoms and imaging evidence of ALI within 14 days. All patients received tPA with suction thrombectomy following the fast-track thrombolysis protocol. In cases where a persistent thrombus or stenosis was detected, catheter-directed thrombolysis was considered overnight, and patients underwent angiography and reassessment in the operating room subsequently. RESULTS: Patients were classified into two groups based on the STILE trial's established contraindications for endovascular treatment in acute limb ischemia (ALI). If a patient had any of these contraindications, they were placed in the contraindicated group. This resulted in 24 patients (32%) in the contraindicated group and 52 patients (68%) in the non-contraindicated group. No statistically significant demographic variations were observed between these groups. Contraindications in our study included uncontrolled hypertension (12/24, 50%), recent invasive procedures (7/27, 29%), history of cerebrovascular accident (CVA) within 6 months (3/24, 12%), and intracranial malformation/neoplasms (2/24, 8%). Three patients within the non-contraindicated group experienced bleeding complications: two with puncture site bleeds and one with nasal bleeding. In contrast, one patient in the contraindicated group had transient postoperative hematuria. There were no significant differences in bleeding complications observed between the two groups (p = .771). Additionally, no amputations were observed within our population. CONCLUSIONS: In light of our study results and advancements in endovascular therapies, we can now safely and efficiently treat patients who were previously considered contraindicated for such treatments. It is essential to individualize treatments and carefully balance the risks and benefits of endovascular versus open surgical revascularization for these patients. Additionally, we believe that the nearly 30-year-old guidelines for endovascular therapies need to be revisited and updated to align with modern technology.

Pharmacomechanical thrombectomy with Angiojet in acute arterial occlusions: A prospective study among the results and outcomes.

OBJECTIVE: The main objective of this present paper was to evaluate the results and outcomes of patients with acute limb ischemia (ALI) submitted to pharmacomechanical thrombectomy (PMT) endovascular surgery with Angiojet, regarding the number of cycles/pumps. METHODS: Prospective, consecutive cohort study of ALI patients submitted to PMT endovascular intervention subdivided into two groups according to the number of cycles in the Angiojet technique: Group 1 higher than 150 cycles/second and Group 2 lesser than 150 cycles/second (cycles/s). RESULTS: Overall, 92 patients with ALI submitted to PMT were evaluated. Two groups of patients were identified: Group 1 higher than 150 cycles/s with 60 patients and Group 2 lesser than 150 cycles/s with 32 patients. The overall mortality rate (OMR) was 15.1% (13 patients) in total cohort within the first 30 days. Group 1 had a higher OMR than Group 2 (16.1% vs 9.3%, p = 0.007). There were 4 cases of hematuria (4.3%), all of them in Group 1. We have performed a Kaplan-Meier regarding limb salvage rates: Group 1 had 85% and Group 2 had 95.7% at 1057 days. P = 0.081. Among the factors evaluated, the following were related to overall mortality rate: PMT with higher >150 cycles/s (HR = 7.17, p = 0.007, CI: 1.38-8.89), COVID-19 infection (HR = 2.75, p = 0.010, CI = 1.73-5.97), and post-operative acute kidney injury (HR = 2.97, p < 0.001, CI = 1.32-8.13). Among the factors evaluated, the following was related to limb loss: post-operative acute kidney injury (HR = 4.41, p = 0.036, CI: 1.771-7.132), probably because patients experiencing limb loss have a higher incidence of acute renal insufficiency due to higher circulating myoglobin higher hemolysis from the increased Angiojet cycles inducing rhabdomyolysis. CONCLUSION: PMT with Angiojet is a safe and effective therapy in patients with ALI. However, patients receiving greater than 150 cycles/s were noted to have higher rates of acute kidney injury and mortality. This is likely reflective of increased thrombus burden and higher rates of hemolysis. Acute kidney injury, greater than 150 cycles/s, and COVID-19 infection were the variables with the strongest association to perioperative mortality.

Short-term outcomes of endovascular management of acute limb ischemia using aspiration mechanical thrombectomy.

OBJECTIVE: Management of acute limb ischemia (ALI) has seen greater utilization of catheter-based interventions over the last two decades. Data on their efficacy is largely based on comparisons of catheter-directed thrombolysis (CDT) and open thrombectomy. During this time, many adjuncts to CDT have emerged with different mechanisms of action, including pharmacomechanical thrombolysis (PMT) and aspiration mechanical thrombectomy (AMT). However, the safety and efficacy of newer adjuncts like AMT have not been well established. This study is a retrospective analysis of the contemporary management of ALI comparing patients treated with aspiration mechanical thrombectomy to patients treated with the more established CDT adjunct, pharmacomechanical thrombolysis. METHODS: Patients undergoing peripheral endovascular intervention for ALI using an adjunctive device were identified through query of the Vascular Quality Initiative (VQI) Peripheral Vascular Intervention (PVI) module from 2014 to 2019. Patients with a nonviable extremity (Rutherford ALI Stage 3), prior history of ipsilateral major amputation, popliteal aneurysm, procedures that were deemed elective (>72 h from admission), procedures that did not utilize an endovascular adjunctive device, and patients without short-term follow-up were all excluded from analysis. The primary outcome was a composite outcome of freedom from major amputation and/or death in the perioperative time period. RESULTS: We identified 528 patients with Rutherford ALI Stage 1 or 2 who were treated with an endovascular adjunct. 433 patients did not undergo aspiration mechanical thrombectomy (no AMT group) and 95 patients did undergo aspiration mechanical thrombectomy (AMT group). The amputation-free survival across all patients was 93.4%. There were significant differences in demographic, comorbidity, and treatment variables between groups (e.g., gender, prior percutaneous coronary intervention (PCI), history of prior peripheral artery disease intervention, and history of prior infra-inguinal PVI), so a propensity score matched analysis was included to account for these group differences. In the propensity score matched analysis, there was no significant difference in major amputation (AMT 7.4% vs no AMT 3.2%, p = 0.13) or death (AMT 95.8% survival vs no AMT 98.4% survival, p = 0.23) with the use of aspiration mechanical thrombectomy. However, there was significantly worse amputation-free survival with the use of aspiration mechanical thrombectomy (AMT 88.4% vs no AMT 95.3%, p = 0.03). On multivariate analysis, prior supra-inguinal bypass (OR 4.85, 1.70-13.84, p = 0.003), Rutherford ALI Stage 2B (OR 3.13, 1.47-6.67, p = 0.003), and aspiration mechanical thrombectomy (OR 2.71, 1.03-7.17, p = 0.05) were associated with the composite outcome. CONCLUSIONS: Short-term amputation-free survival rates of endovascular management of acute limb ischemia are adequate across all modalities. However, aspiration mechanical thrombectomy was associated with significantly worse amputation-free survival compared to other endovascular adjuncts alone (i.e., pharmacomechanical thrombolysis). Severe limb ischemia (Rutherford ALI Stage 2B) and prior supra-inguinal bypass were associated with worse amputation-free survival regardless of the choice of endovascular intervention.

Clinical impact of fluoropolymer-based drug-eluting stent thrombosis in femoropopliteal artery occlusive lesions.

BACKGROUND: Endovascular treatment (EVT) is recommended for superficial femoral artery (SFA) lesions, and good results have been reported after implantation of drug-eluting stents (DES) for SFA. However, the major concern after implantation is acute thrombosis during the follow-up period, resulting in major amputation and major adverse limb events. In this study, we examined the incidence and outcome of acute thrombosis after DES implantation in the SFA. OBJECTIVES AND METHODS: DES implantation for a femoropopliteal lesion was performed in 288 patients at multiple centers in Japan from 2019 to 2021. A total of 25 patients (8.6%) with DES acute occlusion were analyzed retrospectively. The primary endpoint was amputation-free survival (AFS) after acute occlusion. RESULTS: The median patient age was 77 years, with 48% having diabetes, 40% undergoing maintenance dialysis, and 66% having chronic limb-threatening ischemia (CLTI). The mean time from initial DES implantation to acute occlusion was 153.5 ± 177.6 days, with a median of 104 days. EVT was performed in 18 patients (72%), surgical revascularization in 3 (12%), and conservative treatment in 4 (16%). Two deaths within 30 days were both due to sepsis. No major amputation or major adverse cardiovascular events occurred within 30 days. The 1-year rates of patency and freedom from target lesion revascularization after DES thrombosis were 22.9% and 48.8%, respectively. AFS at 1 year was 55.1%. CONCLUSION: Acute DES occlusion is relatively frequent, and the outcome is poor. Therefore, the indication of DES implantation for a complex SFA lesion may require careful consideration. Further investigation may be needed in DES implantation for a complex SFA lesion.

Clinical evolution of patients with lower extremity peripheral artery disease during the COVID-19 pandemic (the COVID-PAD study).

Background: The COVID-19 pandemic has led to significant disruptions in chronic disease care and forced people to stay at home. The effects of such issues on outpatients with lower extremity peripheral artery disease (PAD) remain unknown. Patients and methods: Single-centre, retrospective-prospective study conducted in a Swiss University Hospital. Patients with PAD were included between May 1 and July 31, 2020, with a follow-up visit at 12 months. Upon both visits, the Leriche-Fontaine PAD stage was recorded, and study participants underwent ankle-brachial index (ABI) calculation to assess limb perfusion. Functional capacities were assessed through the 6-minute walking and treadmill tests. Major adverse cardiovascular (MACE) and limb events (MALE) were recorded. Data collected during the pandemic were compared with the pre-pandemic period (January 1, 2019-April 30, 2020). Results: Overall, 259 patients were included. Mean age was 69 years and male sex was prevalent (69.1%). Odds of experiencing a degradation in PAD stage were lower during the pandemic than before (odds ratio [OR]: 0.43; 95% confidence interval [CI]: 0.21-0.87; p = 0.018). No significant difference was found between periods in terms of ABI trends. Both pain-free walking time at treadmill test (p = 0.003) and maximal pain intensity at 6-minute walking test (p = 0.001) significantly improved during the pandemic. Compared with the pre-pandemic period, during the pandemic patients were hospitalized less frequently (p = 0.028) and were less likely to undergo elective limb revascularization (p<0.001). No significant difference was found between periods in terms of MALE (p = 0.311), whereas non-fatal strokes were less frequently reported during the pandemic (p = 0.043). Conclusion: In a cohort of outpatients with PAD, we found no evidence of clinical deterioration during the pandemic compared with the pre-pandemic period, though rates of adverse events were nonnegligible in both periods. In case of future pandemics, patients with PAD should be encouraged to maintain an active lifestyle while being closely monitored to avoid clinical worsening.