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BACKGROUND: In hemodynamically stable patients with acute pulmonary embolism (PE), the Composite Pulmonary Embolism Shock (CPES) score predicts normotensive shock. However, it is unknown if CPES predicts adverse clinical outcomes. The objective of this study was to determine whether the CPES score predicts in-hospital mortality, resuscitated cardiac arrest, or hemodynamic deterioration. METHODS: Patients with acute intermediate-risk PE admitted from October 2016 to July 2019 were included. CPES was calculated for each patient. The primary outcome was a composite of in-hospital mortality, resuscitated cardiac arrest, or hemodynamic decompensation. Secondary outcomes included individual components of the primary outcome. The association of CPES with primary and secondary outcomes was evaluated. RESULTS: Among the 207 patients with intermediate-risk PE (64.7% with intermediate-high risk PE), 29 (14%) patients had a primary outcome event. In a multivariable model, a higher CPES score was associated with a worse primary composite outcome (adjusted hazard ratio [aHR], 1.81 [95% CI, 1.29-2.54]; P=0.001). Moreover, a higher CPES score predicted death (aHR, 1.76 [95% CI, 1.04-2.96]; P=0.033), resuscitated cardiac arrest (aHR, 1.99 [95% CI, 1.17-3.38]; P=0.011), and hemodynamic decompensation (aHR, 1.96 [95% CI, 1.34-2.89]; P=0.001). A high CPES score (≥3) was associated with the worse primary outcome when compared with patients with a low CPES score (22% versus 2.4%; P=0.003; aHR, 6.48 [95% CI, 1.49-28.04]; P=0.012). CPES score provided incremental prognostic value for the prediction of primary outcome over baseline demographics and European Society of Cardiology intermediate-risk subcategories (global Χ2 value increased from 0.63 to 1.39 to 13.69; P=0.005). CONCLUSIONS: In patients with acute intermediate-risk PE, the CPES score effectively risk stratifies and prognosticates patients for the prediction of clinical events and provides incremental value over baseline demographics and European Society of Cardiology intermediate-risk subcategories.
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BACKGROUND: Clot-in-transit is associated with high mortality, but optimal management strategies remain uncertain. The aim of this study was to compare the outcomes of different treatment strategies in patients with clot-in-transit. METHODS: This is a retrospective study of patients with documented clot-in-transit in the right heart on echocardiography across 2 institutions between January 2020 and October 2023. The primary outcome was a composite of in-hospital mortality, resuscitated cardiac arrest, or hemodynamic decompensation. RESULTS: Among 35 patients included in the study, 10 patients (28.6%) received anticoagulation alone and 2 patients (5.7%) received systemic thrombolysis, while 23 patients (65.7%) underwent catheter-based therapy (CBT; 22 mechanical thrombectomy and 1 catheter-directed thrombolysis). Over a median follow-up of 30 days, 9 patients (25.7%) experienced the primary composite outcome. Compared with anticoagulation alone, patients who received CBT or systemic thrombolysis had significantly lower rates of the primary composite outcome (12% versus 60%; log-rank P<0.001; hazard ratio, 0.13 [95% CI, 0.03-0.54]; P=0.005) including a lower rate of death (8% versus 50%; hazard ratio, 0.10 [95% CI, 0.02-0.55]; P=0.008), resuscitated cardiac arrest (4% versus 30%; hazard ratio, 0.12 [95% CI, 0.01-1.15]; P=0.067), or hemodynamic deterioration (4% versus 30%; hazard ratio, 0.12 [95% CI, 0.01-1.15]; P=0.067). CONCLUSIONS: In this study of CBT in patients with clot-in-transit, CBT or systemic thrombolysis was associated with a significantly lower rate of adverse clinical outcomes, including a lower rate of death compared with anticoagulation alone driven by the CBT group. CBT has the potential to improve outcomes. Further large-scale studies are needed to test these associations.
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OBJECTIVE: Lower extremity acute limb ischemia (LE-ALI) is associated with high morbidity and mortality rates, and a burden on patient quality of life (QoL). There is limited medium- to long-term evidence on mechanical aspiration thrombectomy (MT) in patients with LE-ALI. The STRIDE study was designed to assess safety and efficacy of MT using the Indigo Aspiration System in patients with LE-ALI. Thirty-day primary and secondary endpoints and additional outcomes were previously published. Here, we report 365-day secondary endpoints and QoL data from STRIDE. METHODS: STRIDE was a multicenter, prospective, single-arm, observational cohort study that enrolled 119 patients across 16 sites in the United States and Europe. Patients were treated first-line with MT using the Indigo Aspiration System (Penumbra, Inc). The study completed follow-up in October 2023. Secondary endpoints at 365 days included target limb salvage and mortality. Additionally, the VascuQoL-6 questionnaire, developed for evaluating patient-centered QoL outcomes for peripheral arterial disease, was assessed at baseline and follow-up through 365 days. RESULTS: Seventy-three percent of patients (87/119) were available for 365-day follow-up. Mean age of these patients was 65.0 ± 13.3 years, and 44.8% were female. Baseline ischemic severity was classified as Rutherford I in 12.6%, Rutherford IIa in 51.7%, and Rutherford IIb in 35.6%. In general, baseline and disease characteristics (demographics, medical history, comorbidities, target thrombus) of these patients are similar to the enrolled cohort of 119 patients. The secondary endpoints at 365 days for target limb salvage was 88.5% (77/87) and mortality rate was 12.0% (12/100). VascuQoL-6 improved across all domains, with a median total score improvement from 12.0 (interquartile range, 9.0-15.0) at baseline to 19.0 (interquartile range, 16.0-22.0) at 365 days. CONCLUSIONS: These 365-day results from STRIDE demonstrate that first-line MT with the Indigo Aspiration System for LE-ALI portray continued high target limb salvage rates and improved patient-reported QoL. These findings indicate Indigo as a safe and effective therapeutic option for LE-ALI.
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OBJECTIVE: Endovenous ablation is the standard of care for patients with symptomatic superficial venous insufficiency. For patients with a history of deep vein thrombosis (DVT), concern exists for an increased risk of postprocedural complications, particularly venous thromboembolism. The objective of this study was to evaluate the safety and efficacy of endovenous thermal ablation in patients with a history of DVT. METHODS: The national Vascular Quality Initiative Varicose Vein Registry was queried for superficial venous procedures performed from January 2014 to July 2021. Limbs treated with radiofrequency or laser ablation were compared between patients with and without a DVT history. The primary safety end point was incident DVT or endothermal heat-induced thrombosis (EHIT) II-IV in the treated limb at <3 months of follow-up. The secondary safety end points included any proximal thrombus extension (ie, EHIT I-IV), major bleeding, hematoma, pulmonary embolism, and death due to the procedure. The primary efficacy end point was technical failure (ie, recanalization at <1 week of follow-up). Secondary efficacy end points included the risk of recanalization over time and the postprocedural change in quality-of-life measures. Outcomes stratified by preoperative use of anticoagulation (AC) were also compared among those with prior DVT. RESULTS: Among 33,892 endovenous thermal ablations performed on 23,572 individual patients aged 13 to 90 years, 1698 patients (7.2%) had a history of DVT. Patients with prior DVT were older (P < .001), had a higher body mass index (P < .001), were more likely to be male at birth (P < .001) and Black/African American (P < .001), and had greater CEAP classifications (P < .001). A history of DVT conferred a higher risk of new DVT (1.4% vs 0.8%; P = .03), proximal thrombus extension (2.3% vs 1.6%; P = .045), and bleeding (0.2% vs 0.04%; P = .03). EHIT II-IV, pulmonary embolism, and hematoma risk did not differ by DVT history (P = NS). No deaths from treatment occurred in either group. Continuing preoperative AC in patients with prior DVT did not change the risk of any complications after endovenous ablation (P = NS) but did confer an increased hematoma risk among all endovenous thermal ablations and surgeries (P = .001). Technical failure was similar between groups (2.0% vs 1.2%; P = .07), although a history of DVT conferred an increased recanalization risk over time (hazard ratio, 1.90; 95% confidence interval, 1.46, 2.46; P < .001). The groups had comparable improvements in postprocedural venous clinical severity scores and Heaviness, Aching, Swelling, Throbbing, and Itching scores (P = NS). CONCLUSIONS: Endovenous thermal ablation for patients with a history of DVT was effective. However, appropriate patient counseling regarding a heightened DVT risk, albeit still low, is critical. The decision to continue or withhold AC preoperatively should be tailored on a case-by-case basis.
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OBJECTIVES: Generative artificial intelligence (AI) has emerged as a promising tool to engage with patients. The objective of this study was to assess the quality of AI responses to common patient questions regarding vascular surgery disease processes. METHODS: OpenAI's ChatGPT-3.5 and Google Bard were queried with 24 mock patient questions spanning seven vascular surgery disease domains. Six experienced vascular surgery faculty at a tertiary academic center independently graded AI responses on their accuracy (rated 1-4 from completely inaccurate to completely accurate), completeness (rated 1-4 from totally incomplete to totally complete), and appropriateness (binary). Responses were also evaluated with three readability scales. RESULTS: ChatGPT responses were rated, on average, more accurate than Bard responses (3.08 ± 0.33 vs 2.82 ± 0.40, p < .01). ChatGPT responses were scored, on average, more complete than Bard responses (2.98 ± 0.34 vs 2.62 ± 0.36, p < .01). Most ChatGPT responses (75.0%, n = 18) and almost half of Bard responses (45.8%, n = 11) were unanimously deemed appropriate. Almost one-third of Bard responses (29.2%, n = 7) were deemed inappropriate by at least two reviewers (29.2%), and two Bard responses (8.4%) were considered inappropriate by the majority. The mean Flesch Reading Ease, Flesch-Kincaid Grade Level, and Gunning Fog Index of ChatGPT responses were 29.4 ± 10.8, 14.5 ± 2.2, and 17.7 ± 3.1, respectively, indicating that responses were readable with a post-secondary education. Bard's mean readability scores were 58.9 ± 10.5, 8.2 ± 1.7, and 11.0 ± 2.0, respectively, indicating that responses were readable with a high-school education (p < .0001 for three metrics). ChatGPT's mean response length (332 ± 79 words) was higher than Bard's mean response length (183 ± 53 words, p < .001). There was no difference in the accuracy, completeness, readability, or response length of ChatGPT or Bard between disease domains (p > .05 for all analyses). CONCLUSIONS: AI offers a novel means of educating patients that avoids the inundation of information from "Dr Google" and the time barriers of physician-patient encounters. ChatGPT provides largely valid, though imperfect, responses to myriad patient questions at the expense of readability. While Bard responses are more readable and concise, their quality is poorer. Further research is warranted to better understand failure points for large language models in vascular surgery patient education.
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OBJECTIVE: Acute limb ischemia (ALI) is associated with high rates of amputation and consequent morbidity and mortality. The objective of this study is to report on the safety and efficacy of aspiration thrombectomy using the Indigo Aspiration System in patients with lower extremity (LE) ALI. METHODS: The STRIDE study was an international, multicenter, prospective, study that enrolled 119 participants presenting with LE-ALI. Patients were treated firstline with mechanical thrombectomy using the Indigo Aspiration System, before stenting or angioplasty, or other therapies as determined by treating physician. The primary end point was target limb salvage at 30 days after the procedure. Secondary end points within 30 days included technical success, defined as core laboratory-adjudicated Thrombolysis in Myocardial Infarction (TIMI) 2/3 flow rate immediately after the procedure, changes in modified Society for Vascular Surgery runoff score, improvement of Rutherford classification compared with before the procedure, patency, rate of device-related serious adverse events, and major periprocedural bleeding. Secondary end points that will be evaluated at 12 months include target limb salvage and mortality. RESULTS: Of the 119 participants enrolled at 16 sites, the mean age was 66.3 years (46.2% female). At baseline (n = 119), ischemic severity was classified as Rutherford I in 10.9%, Rutherford IIa in 54.6%, and Rutherford IIb in 34.5%. The mean target thrombus length was 125.7 ± 124.7 mm. Before the procedure, 93.0% (of patients 107/115) had no flow (TIMI 0) through the target lesion. The target limb salvage rate at 30 days was 98.2% (109/111). The rate of periprocedural major bleed was 4.2% (5/119) and device-related serious adverse events was 0.8% (1/119). Restoration of flow (TIMI 2/3) was achieved in 96.3% of patients (105/109) immediately after the procedure. The median improvement in the modified Society for Vascular Surgery runoff score (before vs after the procedure) was 6.0 (interquartile range, 0.0-11.0). Rutherford classifications also improved after discharge in 86.5% of patients (83/96), as compared with preprocedural scores. Patency at 30 days was achieved in 89.4% of patients (101/113). CONCLUSIONS: In the STRIDE (A Study of Patients with Lower Extremity Acute Limb Ischemia to Remove Thrombus with the Indigo Aspiration System) study, aspiration thrombectomy with the Indigo System provided a safe and effective endovascular treatment for patients with LE-ALI, resulting in a high rate (98.2%) of successful limb salvage at 30 days, with few periprocedural complications.
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Arteriopatías Oclusivas , Procedimientos Endovasculares , Infarto del Miocardio , Enfermedad Arterial Periférica , Trombosis , Anciano , Femenino , Humanos , Masculino , Enfermedad Aguda , Arteriopatías Oclusivas/etiología , Procedimientos Endovasculares/efectos adversos , Isquemia/diagnóstico por imagen , Isquemia/cirugía , Extremidad Inferior/irrigación sanguínea , Infarto del Miocardio/etiología , Enfermedad Arterial Periférica/diagnóstico por imagen , Enfermedad Arterial Periférica/terapia , Estudios Prospectivos , Estudios Retrospectivos , Factores de Riesgo , Trombectomía/efectos adversos , Trombosis/etiología , Resultado del TratamientoRESUMEN
OBJECTIVE: The aim of this study was to investigate the natural history of internal carotid artery (ICA) stenosis progression. METHODS: This single-institution retrospective cohort study analyzed patients diagnosed with ICA stenosis of 50% or greater on duplex ultrasound from 2015 to 2022. Subjects were drawn from our institutional Intersocietal Accreditation Commission-accredited noninterventional vascular laboratory database. Primary outcomes were incidences of disease progression, and stroke or revascularization after index study. Progression was defined as an increase in stenosis classification category. Imaging, demographic, and clinical data was obtained from our institutional electronic medical record via a database mining query. Cases were analyzed at the patient and artery levels, with severity corresponding to the greatest degree of ICA stenosis on index and follow-up studies. RESULTS: Of 577 arteries in 467 patients, mean cohort age was 73.5 ± 8.9 years at the time of the index study, and 45.0% (n = 210) were female. Patients were followed with duplex ultrasound for a mean of 42.2 ± 22.7 months. Of 577 arteries, 65.5% (n = 378) at the index imaging study had moderate (50%-69%) stenosis, 23.7% (n = 137) had severe (70%-99%) stenosis, and 10.7% (n = 62) were occluded. These three groups had significant differences in age, hypertension, hyperlipidemia prevalence, and proportion on best medical therapy. Of the 467-patient cohort, 56.5% (n = 264) were on best medical therapy, defined as smoking cessation, treatment with an antiplatelet agent, statin, and antihypertensive and glycemic agents as indicated. Mean time to progression for affected arteries was 28.0 ± 20.5 months. Of those arteries with nonocclusive disease at diagnosis, 21.3% (n = 123) progressed in their level of stenosis. Older age, diabetes, and a history of vasculitis were associated with stenosis progression, whereas antiplatelet agent use trended towards decreased progression rates. Of the 467 patients, 5.6% (n = 26) developed symptoms; of those, 38.5% (n = 10) had ischemic strokes, 26.9% (n = 7) had hemispheric transient ischemic attacks, 11.5% (n = 3) had amaurosis fugax, and 23.1% (n = 6) had other symptoms. A history of head and neck cancer was positively associated with symptom development. Of 577 affected arteries, 16.6% (n = 96) underwent intervention; 81% (n = 78) of interventions were for asymptomatic disease and 19% (n = 18) were for symptomatic disease. No patient-level factors were associated with risk of intervention. CONCLUSIONS: A significant number of carotid stenosis patients experience progression of disease. Physicians should consider long-term surveillance on all patients with carotid disease, with increased attention paid to those with risk factors for progression, particularly those with diabetes and a history of vasculitis.
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Estenosis Carotídea , Diabetes Mellitus , Vasculitis , Humanos , Femenino , Persona de Mediana Edad , Anciano , Anciano de 80 o más Años , Masculino , Estenosis Carotídea/diagnóstico por imagen , Estenosis Carotídea/epidemiología , Estenosis Carotídea/terapia , Estudios Retrospectivos , Constricción Patológica/complicaciones , Inhibidores de Agregación Plaquetaria , Arteria Carótida Interna/diagnóstico por imagen , Progresión de la Enfermedad , Ultrasonografía Doppler Dúplex , Factores de Riesgo , Vasculitis/complicacionesRESUMEN
OBJECTIVE: To compare thrombus removal and residual venous symptoms and signs of disease following interventional treatment of iliofemoral deep vein thrombosis (DVT) with mechanical thrombectomy (MT) and pharmacomechanical catheter directed thrombolysis (PCDT). METHODS: Retrospective cohort analysis of propensity score matched subgroups from the multicentre prospective MT ClotTriever Outcomes registry and the PCDT arm of the randomised Acute Venous Thrombosis: Thrombus Removal with Adjunctive Catheter Directed Thrombolysis trial. Patients with bilateral DVT, symptom duration greater than four weeks, isolated femoral-popliteal disease, or incomplete case data were excluded. Patients with iliofemoral DVT were propensity score matched (1:1) on 10 baseline covariables, including race, sex, age, body mass index, leg treated, prior thromboembolism, Marder score, symptom duration, provoked deep vein thrombosis status, and Villalta score. Reduction in post-procedure thrombus burden (i.e., Marder scores), assessment of venous symptoms and signs (i.e., Villalta scores) at 12 months, and healthcare resource utilisation were compared between subgroups. RESULTS: Propensity score matching resulted in 130 patient pairs with no significant differences in baseline characteristics between the MT and PCDT groups. MT was associated with a greater reduction in Marder scores (91.0% vs. 67.7%, p < .001), and a greater proportion of patients at 12 months with no post-thrombotic syndrome (83.1% vs. 63.6%, p = .007) compared with matched patients receiving PCDT. No differences in rates of adjunctive stenting or venoplasty were identified (p = .27). Higher rates of single session treatment were seen with MT (97.7% vs. 26.9%, p < .001), which also showed shorter mean post-procedure hospital stays (1.81 vs. 3.46 overnights, p < .001), and less post-procedure intensive care unit utilisation (2.3% vs. 52.8%, p < .001). CONCLUSION: Compared with PCDT, MT was associated with greater peri-procedural thrombus reduction, more efficient post-procedure care, and improved symptoms and signs of iliofemoral vein disease at 12 months.
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Síndrome Postrombótico , Trombosis de la Vena , Humanos , Terapia Trombolítica/efectos adversos , Fibrinolíticos , Estudios Retrospectivos , Puntaje de Propensión , Estudios Prospectivos , Vena Femoral/diagnóstico por imagen , Resultado del Tratamiento , Vena Ilíaca/diagnóstico por imagen , Trombosis de la Vena/diagnóstico por imagen , Trombosis de la Vena/terapia , Síndrome Postrombótico/etiología , Catéteres , Trombectomía/efectos adversosRESUMEN
OBJECTIVE: Investigations into imaging modalities in the diagnosis of extracranial carotid artery occlusion (CAO) have raised questions about the inter-modality comparability of duplex ultrasound (DUS) and cross-sectional imaging (CSI). This study examines the relationship between DUS and CSI diagnoses of extracranial CAO. METHODS: This single-institution retrospective analysis studied patients with CAO diagnosed by DUS from 2010 to 2021. Patients were identified in our office-based accredited vascular laboratory database. Imaging and clinical data was obtained via our institutional electronic medical record. Primary outcome was discrepancy between DUS and CSI modalities. Secondary outcomes included incidence of stroke and intervention subsequent to CAO diagnosis. RESULTS: Of our 140-patient cohort, 95 patients (67.9%) had DUS follow-up (mean, 42.7 ± 31.3 months). At index duplex, 68.0% of individuals (n = 51) were asymptomatic. Seventy-five patients (53.6%) had CSI of the carotids after DUS CAO diagnosis; 18 (24%) underwent magnetic resonance imaging and 57 (76%) underwent computed tomography. Indications for CSI included follow-up of DUS findings of carotid stenosis/occlusion (44%), stroke/transient ischemic attack (16%), other symptoms (12%), preoperative evaluation (2.7%), unrelated pathology follow-up (9.3%), and outside institution imaging with unavailable indications (16%). When comparing patients with CSI and those without, there were no differences with regard to symptoms at diagnosis, prior neck interventions, or hypertension. There was a significant difference between cross-sectionally imaged and non-imaged patients in anti-hypertensive medications (72% vs 53.8%; P = .04). Despite initial DUS diagnoses of carotid occlusion, 10 patients (13.3%) ultimately had CSI indicating patent carotids. Four of these 10 patients had stenoses of â¼99% (with 1 string sign), four of 70% to 99%, one of 50% to 69%, and one of less than 50% on CSI. The majority of patients (70%) had CSI within 1 month of the index ultrasound. There were no significant relationships between imaging discrepancies and body mass index, heart failure, upper body edema, carotid artery calcification, and neck hardware. Eight individuals (10.7%) underwent ipsilateral revascularization; 62.5% (n = 5) were carotid endarterectomy procedures, and the remaining three procedures were a transcervical carotid revascularization, subclavian to internal carotid artery bypass, and transfemoral carotid artery stenting. Eight patients (10.7%) underwent contralateral revascularization, with the same distribution of procedures as those ipsilateral to occlusions. Two of the 10 patients with discrepancies underwent carotid endarterectomy, and one underwent carotid stenting. CONCLUSIONS: In our experience, duplex diagnosis of CAO is associated with a greater than 10% discordance when compared with CSI. These patients may benefit from closer surveillance as well as confirmatory computed tomography or magnetic resonance angiography. Further work is needed to determine the optimal diagnostic modality for CAO.
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Enfermedades de las Arterias Carótidas , Estenosis Carotídea , Endarterectomía Carotidea , Accidente Cerebrovascular , Humanos , Estenosis Carotídea/diagnóstico por imagen , Estenosis Carotídea/cirugía , Estudios Retrospectivos , Stents/efectos adversos , Enfermedades de las Arterias Carótidas/complicaciones , Endarterectomía Carotidea/efectos adversos , Arteria Carótida Interna/diagnóstico por imagen , Ultrasonografía Doppler Dúplex , Arterias Carótidas , Accidente Cerebrovascular/diagnóstico por imagen , Accidente Cerebrovascular/etiología , Resultado del TratamientoRESUMEN
OBJECTIVE: The objective of this study was to investigate the administrative and clinical impacts of prior authorization (PA) processes in the office-based laboratory (OBL) setting. METHODS: This single-institution, retrospective analysis studied all OBL PAs pursued between January 2018 and March 2022. Case, PA, and coding information was obtained from the practice's scheduling database. RESULTS: Over the study period, 1854 OBL cases were scheduled; 8% (n = 146) required PA. Of these, 75% (n = 110) were for lower extremity arterial interventions, 19% (n = 27) were for deep venous interventions, and 6% (n = 9) were for other interventions. Of 146 PAs, 19% (n = 27) were initially denied but 74.1% (n = 7) of these were overturned on appeal. Deep venous procedures were initially denied, at 43.8% (n = 14), more often than were arterial procedures, at 11.8% (n = 13). Of 146 requested procedures, 4% (n = 6) were delayed due to pending PA determination by a mean 14.2 ± 18.3 working days. An additional 6% (n = 8) of procedures were performed in the interest of time before final determination. Of the seven terminally denied procedures, 57% (n = 4) were performed at cost to the practice based on clinical judgment. CONCLUSIONS: Using PA appeals mechanisms, while administratively onerous, resulted in the overturning of most initial denials.
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Autorización Previa , Humanos , Estudios RetrospectivosRESUMEN
PURPOSE: Mechanical thrombectomy for the treatment of deep vein thrombosis (DVT) is being increasingly utilized to reduce symptoms and prevent postthrombotic syndrome (PTS), but more data on clinical outcomes are needed. Mechanical thrombectomy was studied in the ClotTriever Outcomes (CLOUT) registry with 6-month full analysis outcomes reported herein. MATERIALS AND METHODS: The CLOUT registry is a prospective, all-comer study that enrolled 500 lower extremity DVT patients across 43 US sites treated with mechanical thrombectomy using the ClotTriever System. Core-lab assessed Marder scores and physician-assessed venous patency by duplex ultrasound, PTS assessment using Villalta score, venous symptom severity, pain, and quality of life scores through 6 months were analyzed. Adverse events were identified and independently adjudicated. RESULTS: All-cause mortality at 30 days was 0.9%, and 8.6% of subjects experienced a serious adverse event (SAE) within the first 30 days, 1 of which (0.2%) was device related. SAE rethrombosis/residual thrombus incidence was 4.8% at 30 days and 8.0% at 6 months. Between baseline and 6 months, venous flow increased from 27.2% to 92.5% of limbs (P < 0.0001), and venous compressibility improved from 28.0% to 91.8% (P < 0.0001), while median Villalta scores improved from 9.0 at baseline to 1.0 at 6 months (P < 0.0001). Significant improvements in venous symptom severity, pain, and quality of life were also demonstrated. Outcomes from iliofemoral and isolated femoral-popliteal segments showed similar improvements. CONCLUSION: Outcomes from the CLOUT study, a large prospective registry for DVT, indicate that mechanical thrombectomy is safe and demonstrates significant improvement in symptoms and health status through 6 months. Level of Evidence 3: Non-randomized controlled cohort/follow-up study.
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Síndrome Postrombótico , Trombosis de la Vena , Humanos , Trombectomía/efectos adversos , Vena Femoral , Estudios de Seguimiento , Calidad de Vida , Vena Ilíaca , Resultado del Tratamiento , Grado de Desobstrucción Vascular , Trombosis de la Vena/diagnóstico por imagen , Trombosis de la Vena/terapia , Terapia Trombolítica/efectos adversosRESUMEN
BACKGROUND: Aberrant subclavian artery (ASA) with or without Kommerell's diverticulum (KD) is a rare anatomic aortic arch anomaly that can cause dysphagia and/or life-threatening rupture. The objective of this study is to compare outcomes of ASA/KD repair in patients with a left versus right aortic arch. METHODS: Using the Vascular Low Frequency Disease Consortium methodology, a retrospective review was performed of patients ≥18 years old with surgical treatment of ASA/KD from 2000 to 2020 at 20 institutions. RESULTS: 288 patients with ASA with or without KD were identified; 222 left-sided aortic arch (LAA), and 66 right-sided aortic arch (RAA). Mean age at repair was younger in LAA 54 vs. 58 years (P = 0.06). Patients in RAA were more likely to undergo repair due to symptoms (72.7% vs. 55.9%, P = 0.01), and more likely to present with dysphagia (57.6% vs. 39.1%, P < 0.01). The hybrid open/endovascular approach was the most common repair type in both groups. Rates of intraoperative complications, death within 30 days, return to the operating room, symptom relief and endoleaks were not significantly different. For patients with symptom status follow-up data, in LAA, 61.7% had complete relief, 34.0% had partial relief and 4.3% had no change. In RAA, 60.7% had complete relief, 34.4% had partial relief and 4.9% had no change. CONCLUSIONS: In patients with ASA/KD, RAA patients were less common than LAA, presented more frequently with dysphagia, had symptoms as an indication for intervention, and underwent treatment at a younger age. Open, endovascular and hybrid repair approaches appear equally effective, regardless of arch laterality.
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Trastornos de Deglución , Divertículo , Cardiopatías Congénitas , Enfermedades Vasculares , Adolescente , Humanos , Aorta Torácica/diagnóstico por imagen , Aorta Torácica/cirugía , Aorta Torácica/anomalías , Trastornos de Deglución/etiología , Trastornos de Deglución/cirugía , Divertículo/diagnóstico por imagen , Divertículo/cirugía , Divertículo/complicaciones , Cardiopatías Congénitas/complicaciones , Arteria Subclavia/diagnóstico por imagen , Arteria Subclavia/cirugía , Arteria Subclavia/anomalías , Resultado del Tratamiento , Enfermedades Vasculares/complicaciones , Adulto , Persona de Mediana EdadRESUMEN
BACKGROUND: Intraoperative dextran infusion has been associated with reduction of an embolic risk in patients undergoing carotid endarterectomy (CEA). Nonetheless, dextran has been associated with adverse reactions, including anaphylaxis, hemorrhage, cardiac, and renal complications. Herein, we aimed to compare the perioperative outcomes of CEA stratified by the use of intraoperative dextran infusion using a large multiinstitutional dataset. METHODS: Patients undergoing CEA between 2008 and 2022 from the Vascular Quality Initiative database were reviewed. Patients were categorized by use of intraoperative dextran infusion, and demographics, procedural data, and in-hospital outcomes were compared. Logistic regression analysis was utilized to adjust for differences in patients while assessing the association between postoperative outcomes and intraoperative infusion of dextran. RESULTS: Of 140,893 patients undergoing CEA, 9,935 (7.1%) patients had intraoperative dextran infusion. Patients with intraoperative dextran infusion were older with lower rates of symptomatic stenosis (24.7% vs. 29.3%; P < 0.001) and preoperative use of antiplatelets, anticoagulants and statins. Additionally, they were more likely to have severe carotid stenosis (>80%; 49% vs. 45%; P < 0.001) and undergo CEA under general anesthesia (96.4% vs. 92.3%; P < 0.001), with a more frequent use of shunt (64.4% vs. 49.5%; P < 0.001). After adjustment, multivariable analysis showed that intraoperative dextran infusion was associated with higher odds of in-hospital major adverse cardiac events (MACE), including myocardial infarction [MI] (odds ratio [OR], 1.76, 95% confidence interval [CI]: 1.34-2.3, P < 0.001), congestive heart failure [CHF] (OR, 2.15, 95% CI: 1.67-2.77, P = 0.001), and hemodynamic instability requiring vasoactive agents (OR, 1.08, 95% CI: 1.03-1.13, P = 0.001). However, it was not associated with decreased odds of stroke (OR, 0.92, 95% CI: 0.74-1.16, P = 0.489) or death (OR, 0.88, 95% CI: 0.58-1.35, P = 0.554). These trends persisted even when stratified by symptomatic status and degree of stenosis. CONCLUSIONS: Intraoperative infusion of dextran was associated with increased odds of MACE, including MI, CHF, and persistent hemodynamic instability, without decreasing the risk of stroke perioperatively. Given these results, judicious use of dextran in patients undergoing CEA is recommended. Furthermore, careful perioperative cardiac management is warranted in select patients receiving intraoperative dextran during CEA.
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Estenosis Carotídea , Endarterectomía Carotidea , Infarto del Miocardio , Accidente Cerebrovascular , Humanos , Endarterectomía Carotidea/efectos adversos , Dextranos/efectos adversos , Constricción Patológica/etiología , Factores de Riesgo , Resultado del Tratamiento , Accidente Cerebrovascular/etiología , Estenosis Carotídea/complicaciones , Estenosis Carotídea/diagnóstico por imagen , Estenosis Carotídea/cirugía , Infarto del Miocardio/etiología , Estudios Retrospectivos , Medición de RiesgoRESUMEN
PURPOSE: To analyze the first 250 patients from the prospective, multicenter, industry-sponsored ClotTriever Outcomes (CLOUT) registry, assessing the safety and effectiveness of mechanical thrombectomy for acute, subacute, and chronic deep vein thrombosis (DVT). MATERIALS AND METHODS: Real-world patients with lower extremity DVT were treated with the ClotTriever System (Inari Medical, Irvine, California). Adjuvant venoplasty, stent placement, or both were performed at the physician's discretion. Thrombus chronicity was determined by visual inspection of removed thrombus, categorizing patients into acute, subacute, and chronic subgroups. Serious adverse events (SAEs) were assessed through 30 days. Clinical and quality-of-life (QoL) outcomes are reported through 6 months. RESULTS: Thrombus chronicity was designated for 244 of the 250 patients (acute, 32.8%; subacute, 34.8%; chronic, 32.4%) encompassing 254 treated limbs. Complete or near-complete (≥75%) thrombus removal was achieved in 90.8%, 81.9%, and 83.8% of the limbs with acute, subacute, and chronic thrombus, respectively. No fibrinolytics were administered, and 243 (99.6%) procedures were single sessions. One (0.4%) patient in the subacute group experienced a device-related SAE, a fatal pulmonary embolism. On comparing baseline and 6-month data, improvements were demonstrated in median Villalta scores (acute, from 10 to 1; subacute, from 9 to 1; chronic, from 10 to 3; for all, P < .0001) and mean EuroQol group 5-dimension (EQ-5D) self-report questionnaire scores (acute, 0.58 to 0.89; subacute, 0.65 to 0.87; chronic, 0.58 to 0.88; for all, P < .0001). There were no significant differences in outcomes across the subgroups. CONCLUSIONS: Mechanical thrombectomy using the ClotTriever System with adjunctive venoplasty and stent placement is safe and similarly effective for acute, subacute, and chronic DVT.
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Trombectomía , Trombosis de la Vena , Humanos , Trombectomía/efectos adversos , Resultado del Tratamiento , Estudios Prospectivos , Calidad de Vida , Terapia Trombolítica , Trombosis de la Vena/diagnóstico por imagen , Trombosis de la Vena/terapia , Trombosis de la Vena/etiología , Sistema de Registros , Vena Ilíaca , Estudios RetrospectivosRESUMEN
OBJECTIVE: Renal transplant is associated with substantial survival advantage in patients with end-stage renal disease. However, little is known about the outcomes of renal transplant recipients (RTRs) after endovascular abdominal aortic aneurysm repair (EVAR). This study aimed to study the effect of renal transplant on perioperative outcomes and long-term survival after elective infrarenal EVAR. METHODS: The Vascular Quality Initiative database was queried for all patients undergoing elective EVAR from 2003 to 2021. Functioning RTRs were compared with non-renal transplant recipients without a diagnosis of end-stage renal disease (non-RTRs). The outcomes included 30-day mortality, acute kidney injury (AKI), new renal failure requiring renal replacement therapy (RRT), endoleak, aortic-related reintervention, major adverse cardiac events, and 5-year survival. A logistic regression analysis was used to assess the association between RTRs and perioperative outcomes. RESULTS: Of 60,522 patients undergoing elective EVAR, 180 (0.3%) were RTRs. RTRs were younger (median, 71 years vs 74.5 years; P < .001), with higher incidence of hypertension (92% vs 84%; P = .004) and diabetes (29% vs 21%; P = .005). RTRs had higher median preoperative serum creatinine (1.3 mg/dL vs 1.0 mg/dL; P < .001) and lower estimated glomerular filtration rate (51.6 mL/min vs 69.4 mL/min; P < .001). There was no difference in the abdominal aortic aneurysm diameter and incidence of concurrent iliac aneurysms. Procedurally, RTRs were more likely to undergo general anesthesia with lower amount of contrast used (median, 68.6 mL vs 94.8 ml; P < .001) and higher crystalloid infusion (median, 1700 mL vs 1500 mL; P = .039), but no difference was observed in the incidence of open conversion, endoleak, operative time, and blood loss. Postoperatively, RTRs experienced a higher rate of AKI (9.4% vs 2.7%; P < .001), but the need for new RRT was similar (1.1% vs 0.4%; P = .15). There was no difference in the rates of postoperative mortality, aortic-related reintervention, and major adverse cardiac events. After adjustment for potential confounders, RTRs remained associated with increased odds of postoperative AKI (odds ratio, 3.33; 95% confidence interval, 1.93-5.76; P < .001) but had no association with other postoperative complications. A subgroup analysis identified that diabetes (odds ratio, 4.21; 95% confidence interval, 1.17-15.14; P = .02) is associated with increased odds of postoperative AKI among RTRs. At 5 years, the overall survival rates were similar (83.4% vs 80%; log-rank P = .235). CONCLUSIONS: Among patients undergoing elective infrarenal EVAR, RTRs were independently associated with increased odds of postoperative AKI, without increased postoperative renal failure requiring RRT, mortality, endoleak, aortic-related reintervention, or major adverse cardiac events. Furthermore, 5-year survival was similar. As such, while EVAR may confer comparable benefits and technical success perioperatively, RTRs should have aggressive and maximally optimized renal protection to mitigate the risk of postoperative AKI.
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Lesión Renal Aguda , Aneurisma de la Aorta Abdominal , Implantación de Prótesis Vascular , Diabetes Mellitus , Procedimientos Endovasculares , Fallo Renal Crónico , Trasplante de Riñón , Humanos , Factores de Riesgo , Medición de Riesgo , Endofuga/etiología , Trasplante de Riñón/efectos adversos , Procedimientos Endovasculares/efectos adversos , Implantación de Prótesis Vascular/efectos adversos , Lesión Renal Aguda/diagnóstico , Lesión Renal Aguda/etiología , Fallo Renal Crónico/complicaciones , Aneurisma de la Aorta Abdominal/diagnóstico por imagen , Aneurisma de la Aorta Abdominal/cirugía , Aneurisma de la Aorta Abdominal/complicaciones , Complicaciones Posoperatorias , Estudios Retrospectivos , Resultado del TratamientoRESUMEN
BACKGROUND: There is a paucity of literature on the natural history of extracranial carotid artery occlusion (CAO). This study reviews the natural history of this patient cohort. METHODS: This single-institution retrospective analysis studied patients with CAO diagnosed by duplex ultrasound between 2010 and 2021. Patients were identified by searching our office-based Intersocietal Accreditation Commission accredited vascular laboratory database. Imaging and clinical data were obtained via our institutional electronic medical record. Outcomes of interest included ipsilateral stroke, attributable neurologic symptoms, and ipsilateral intervention after diagnosis. RESULTS: The full duplex database consisted of 5,523 patients who underwent carotid artery duplex examination during the study period. The CAO cohort consisted of 139 patients; incidence of CAO was 2.5%. Mean age at diagnosis was 69.7 years; 31.4% were female. Hypertension (72.7%), hyperlipidemia (64.7%), and prior smoking (43.9%) were the most common comorbid conditions. Of the CAO cohort, 61.3% (n = 85) of patients were asymptomatic at diagnosis; 38.8% (n = 54) were diagnosed after a stroke or transient ischemic attack occurring within 6 months prior to diagnosis, with 21.6% occurring ipsilateral to the CAO and 10.1% occurring contralateral to the CAO. 7.2% (n = 10) had unclear symptoms or laterality at presentation. Of the CAO cohort, 95 patients (68.3%) had duplex imaging follow-up (mean 42.7 ± 31.3 months). Of those with follow-up studies, 7 patients (5.0%) developed subsequent stroke ipsilateral to the CAO with mean occurrence 27.8 ± 39.0 months postdiagnosis. In addition, 5 patients (3.6%) developed other related symptoms, including global hypoperfusion (2.4%) and transient ischemic attack (1.2%). Of those, 95 patients with follow-up duplex ultrasound imaging, 6 (4.3%) underwent eventual ipsilateral intervention, including carotid endarterectomy (n = 4), transfemoral carotid artery stent (n = 1), and carotid bypass (n = 1), with mean occurrence 17.7 ± 23.7 months postdiagnosis. The aggregate rate of ipsilateral cerebrovascular accident, attributable neurologic symptoms, or ipsilateral intervention was 11.5%. Of 95 patients with follow-up duplex ultrasound imaging, 5 underwent subsequent duplex studies demonstrating ipsilateral patency, resulting in a 5.3% discrepancy rate between sequential duplex studies. All 6 patients undergoing intervention received periprocedural cross-sectional imaging (magnetic resonance angiography or computed tomography angiography). In 5 of these 6 patients, cross-sectional demonstrated severe stenosis rather than CAO, disputing prior duplex ultrasound findings. CONCLUSIONS: In this large, institutional cohort of patients with a CAO diagnosis on duplex ultrasound, a clinically meaningful subset of patients experienced cerebrovascular accident, related symptoms, or intervention. We also found a notable rate of temporal duplex discrepancies among patients with CAO diagnoses and discrepancies between CAO diagnosis per duplex ultrasound and findings on cross-sectional imaging for those patients who underwent intervention. These results suggest that use of a single duplex ultrasound as a sole diagnostic tool in CAO may not be sufficient and that physicians should consider close duplex ultrasound surveillance of these patients, potentially in conjunction with additional confirmatory imaging modalities. Further investigation into optimal workup and surveillance protocols for CAO is needed.
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Enfermedades de las Arterias Carótidas , Estenosis Carotídea , Ataque Isquémico Transitorio , Accidente Cerebrovascular , Humanos , Femenino , Anciano , Masculino , Estenosis Carotídea/diagnóstico por imagen , Estenosis Carotídea/terapia , Estenosis Carotídea/complicaciones , Ataque Isquémico Transitorio/diagnóstico por imagen , Ataque Isquémico Transitorio/etiología , Estudios Retrospectivos , Resultado del Tratamiento , Enfermedades de las Arterias Carótidas/complicaciones , Accidente Cerebrovascular/diagnóstico por imagen , Accidente Cerebrovascular/epidemiología , Accidente Cerebrovascular/etiología , Arterias CarótidasRESUMEN
OBJECTIVES: Clopidogrel is effective at decreasing cardiovascular events in patients with peripheral artery disease (PAD); however, its effect on limb outcomes are less known. This study investigated the variability in response to clopidogrel and its relationship with clinical limb outcomes. METHODS: Three hundred subjects were enrolled in the Platelet Activity and Cardiovascular Events (PACE) study prior to lower extremity revascularization, of whom 104 were on clopidogrel. Light transmission platelet aggregation was measured in response to ADP 2 µm immediately prior to revascularization. Patients were followed longitudinally for a median follow-up of 18 months. The primary endpoint was major adverse limb events (MALE) defined by major amputation or reoperation of the affected limb. Patients were stratified into groups according to percent ADP-induced aggregation. Poor response to clopidogrel was defined by >50% aggregation. RESULTS: Overall, the median age was 70 (63, 76) and 35.6% were female. Twenty-nine (27.9%) patients experienced MALE during their follow-up. Median aggregation to ADP 2 µ m was 22.5% (Q1-Q3: 10%, 50%) and 27 subjects (26%) were clopidogrel poor responders. Baseline aggregation was higher in subjects who went on to develop a MALE than those without MALE (43% vs 20%, p = .017). Subjects with aggregation > median (22.5%) were more likely to experience MALE than aggregation < median (38.5% vs 17.3%, p = .029). After multivariable adjustment for age, sex, race/ethnicity, BMI, diabetes, coronary artery disease, and aspirin use, aggregation > median was associated with MALE (adjusted HR [aHR] 2.67, 95% CI 1.18-6.01, p = .018). When stratified by established cut-offs for responsiveness to clopidogrel (50% aggregation), poor responders were more likely to experience MALE than normal responders (44.4% vs 22.1%, aHR 2.18, 95% CI 1.00-4.78, p = .051). CONCLUSIONS: Among patients undergoing lower extremity revascularization on clopidogrel, higher baseline percent aggregation is associated with increased risk for major adverse limb events.
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Enfermedad de la Arteria Coronaria , Enfermedad Arterial Periférica , Humanos , Femenino , Anciano , Masculino , Clopidogrel/efectos adversos , Extremidad Inferior , Amputación Quirúrgica , Enfermedad Arterial Periférica/diagnóstico , Enfermedad Arterial Periférica/tratamiento farmacológico , Enfermedad Arterial Periférica/cirugíaRESUMEN
OBJECTIVE: The optimal medical management strategy in the periprocedural period for patients undergoing carotid artery interventions is not well described. Renin-angiotensin-system blocking (RASB) agents are considered to be among the first line anti-hypertensive agents; however, their role in the perioperative period is unclear. The objective of this study was to examine the relationship between the use of RASB agents on periprocedural outcomes in patients undergoing carotid interventions-carotid endarterectomy (CEA), transfemoral carotid artery stenting (CAS), and transcervical carotid artery revascularization (TCAR). METHOD: The Society for Vascular Surgery Quality Initiative database was queried for all patients undergoing CAS, CEA, and TCAR between 2003 and 2020. Patients were stratified into two groups based upon their use of RASB agents in the periprocedural period. The primary endpoint was periprocedural neurologic events (including both strokes and transient ischemic attacks (TIAs)). The secondary endpoints were peri-procedural mortality and significant cardiac events, including myocardial infarction, dysrhythmia, and congestive heart failure. RESULTS: Over 150,000 patients were included in the analysis: 13,666 patients underwent TCAR, 13,811 underwent CAS, and 125,429 underwent CEA for carotid artery stenosis. Overall, 52.2% of patients were maintained on RASB agents. Among patients undergoing CEA, patients on RASB agents had a significantly lower rate of periprocedural neurologic events (1.7% versus 2.0%, p =0.001). The peri-procedural neurological event rate in the TCAR cohort was similarly reduced in those treated with RASB agents, but did not reach statistical significance (2.0% vs 2.4%, p = 0.162). Among patients undergoing CAS, there was no difference in perioperative neurologic events between the RASB treated and untreated cohorts (3.4% vs 3.2%, p = 0.234); however, the use of RASB agents was significantly associated with lower mortality (1.2% vs 1.7%, p =0.001) with CAS. The use of preoperative RAS-blocking agents did not appear to affect the overall rates of adverse cardiac events with any of the three carotid intervention types, or periprocedural mortality following CEA or TCAR. On multivariable analysis, the use of RAS-blocking agents was independently associated with lower rates of post-procedural neurologic events in patients undergoing CEA (OR 0.819, CI 0.747-0.898; p = 0.01) and TCAR (OR 0.869, CI 0.768-0.984; p = 0.026), but not in those undergoing CAS (OR 0.967, CI 0.884-1.057; p = 0.461). CONCLUSION: The use of peri-procedural RASB agents was associated with a significantly decreased rate of neurologic events in patients undergoing both CEA and TCAR. This effect was not observed in patients undergoing CAS. As carotid interventions warrant absolute minimization of perioperative complications in order to provide maximum efficacy with regard to stroke protection, the potential neuro-protective effect associated with RASB agents use following CEA and TCAR warrants further examination.
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Estenosis Carotídea , Endarterectomía Carotidea , Accidente Cerebrovascular , Humanos , Estenosis Carotídea/diagnóstico por imagen , Estenosis Carotídea/cirugía , Sistema Renina-Angiotensina , Stents , Arteria Carótida Común , Endarterectomía Carotidea/efectos adversos , Accidente Cerebrovascular/etiología , Accidente Cerebrovascular/prevención & controlRESUMEN
OBJECTIVE: Autologous great saphenous vein (GSV) is considered the conduit of choice for lower extremity bypass (LEB). However, the optimal configuration remains the source of debate. We compared outcomes of patients undergoing LEB using in-situ and reversed techniques. METHODS: The Vascular Quality Initiative database was queried for patients undergoing LEB with a single-segment GSV in in-situ (ISGSV) and reversed (RGSV) configurations for symptomatic occlusive disease from 2003 to 2021. Patient demographics, procedural detail, and in-hospital and follow-up outcomes were collected. The primary outcome measures included primary patency at discharge or 30 days and one year. Secondary outcomes were secondary patency, and reinterventions at discharge or 30 days and one year. Cox proportional hazards models were created to determine the association between bypass techniques and outcomes of interest. RESULTS: Of 8234 patients undergoing LEBs, in-situ and reversed techniques were used in 3546 and 4688 patients, respectively. The indication for LEBs was similar between the two cohorts. ISGSV was performed more frequently from the common femoral artery and to more distal targets. RGSV bypass was associated with higher intraoperative blood loss and longer operative time. Perioperatively, ISGSV cohort had higher rates of reinterventions (13.2 vs 11.1%; p = 0.004), surgical site infection (4.2 vs 3%; p = 0.003), and lower primary patency (93.5 vs 95%; p = 0.004) but a comparable rate of secondary patency (99 vs 99.1%; p = 0.675). At 1 year, in-situ bypasses had a lower rate of reinterventions (19.4% vs 21.6%; p=0.02), with similar rates of primary (82.6 vs 81.8%; p = 0.237) and secondary patency (88.7 vs 88.9%; p = 0.625). After adjusting for significant baseline differences and potential confounders, in-situ bypass was independently associated with decreased risks of primary patency loss (HR 0.9; 95% CI, 0.82-0.98; p = 0.016) and reinterventions (HR 0.88; 95% CI, 0.8-0.97; p = 0.014) but a similar risk of secondary patency loss (HR 0.99; 95% CI, 0.86-1.16; p = 0.985) at follow-up, compared to reversed bypass. A subgroup analysis of bypasses to crural targets showed that in-situ and reversed bypasses had similar rates of primary patency loss and reinterventions at 1 year. Among patients with chronic limb-threatening ischemia, in-situ bypass was associated with a decreased risk of reinterventions but similar rates of primary and secondary patency and major amputations at 1 year. CONCLUSIONS: In patients undergoing LEBs using the GSV, in-situ configuration was associated with more perioperative reinterventions and lower primary patency rate. However, this was offset by decreased risks of loss of primary patency and reinterventions at 1 year. A thorough intraoperative graft assessment with adjunctive imaging may be performed to detect abnormalities in patients undergoing in-situ bypasses to prevent early failures. Furthermore, closer surveillance of reversed bypass grafts is warranted given the higher rates of reinterventions.