Lower Extremity Peripheral Vascular Intervention Research Articles

Intravascular Ultrasound Use is Associated with Improved Patency in Lower Extremity Peripheral Arterial Interventions

ObjectivesIntravascular ultrasound (IVUS) facilitates detailed visualization of endoluminal anatomy not adequately appreciated on conventional angiography. However, it is unclear if IVUS use improves clinical outcomes of peripheral vascular interventions (PVI) for peripheral arterial disease (PAD). This study aimed to evaluate the impact of IVUS on 1-year outcomes of PVI in the vascular quality initiative (VQI). MethodsThe VQI-PVI modules were reviewed (2016-2020). All patients with available one-year follow up after lower extremity PVI were included and grouped as IVUS-PVI or non-IVUS PVI based on use of IVUS. Propensity matching (1:1) was performed using demographics and comorbidities. One-year major amputation and patency rates were compared. A generalized estimating equation (GEE) model was used to identify predictors of 1-year outcomes. Subgroup analysis based on Trans-Atlantic Inter-Society Consensus (TASC) classification, treatment length and treatment modalities were performed using same modeling approaches. ResultsThere were 56,633 procedures (non-IVUS PVI=55,302 vs IVUS-PVI=1,331) in 44,042 patients. Propensity matching yielded a total cohort of 1,854 patients matched (1:1), with no baseline differences. LER for claudication was performed in 60.4%, while one-third (33.9%) had chronic limb threatening ischemia (CLTI). IVUS was more commonly used for lesions >15cm in length (46.6% vs 43.3%) and for aortoiliac disease (31.8% vs 27.2%). Rates of atherectomy and stenting were significantly higher with IVUS-PVI (21.1% vs 16.8%), while balloon angioplasty was less common (13.5% vs 24.4%). One-year patency was better with IVUS-PVI (97.7% vs 95.2%, p=0.004). On subgroup analysis, IVUS (OR 2.20, 95% CI 1.29- 3.75) was associated with improved patency in CLTI patients, TASC C or D lesions, and treatment length >15cm. Adjunctive IVUS use during PVI did not significantly impact 1-year amputation (OR 1.7, 95%CI 0.78-3.91). On multivariable regression, adjunctive use of IVUS (OR 2.46 95%CI 1.43-4.25) and aortoiliac interventions (OR 2.91, 95%CI 1.09-7.75) were independent predictors of patency. Treatment modalities such as atherectomy, stenting or balloon angioplasty did not significantly impact patency at 1-year. ConclusionIVUS during lower extremity PVI is associated with improved 1-year patency, when compared to angiography alone. Certain subgroups, such as CLTI patients, lesions>15cm, and TASC C or D lesions might benefit from adjunctive use of IVUS.

Outcomes of atherectomy in patients undergoing lower extremity revascularisation.

There is a paucity of real-world data on the in-hospital (IH) and post-discharge outcomes in patients undergoing lower extremity peripheral vascular intervention (PVI) with adjunctive atherectomy. In this retrospective, registry-based study, we evaluated IH and post-discharge outcomes among patients undergoing PVI, treated with or without atherectomy, in the National Cardiovascular Data Registry PVI Registry. The IH composite endpoint included procedural complications, bleeding or thrombosis. The primary out-of-hospital endpoint was major amputation at 1 year. Secondary endpoints included repeat endovascular or surgical revascularisation and death. Multivariable regression was used to identify predictors of atherectomy use and its association with clinical endpoints. A total of 30,847 patients underwent PVI from 2014 to 2019, including 10,971 (35.6%) treated with atherectomy. The unadjusted rate of the IH endpoint occurred in 524 (4.8%) of the procedures involving atherectomy and 1,041 (5.3%) of non-atherectomy procedures (p=0.07). After adjustment, the use of atherectomy was not associated with an increased risk of the combined IH endpoint (p=0.68). In the 6,889 (22.4%) patients with out-of-hospital data, atherectomy was associated with a reduced risk of amputation (adjusted hazard ratio [aHR] 0.67, 95% confidence interval [CI]: 0.51-0.85; p<0.01) and surgical revascularisation (aHR 0.63, 95% CI: 0.44-0.89; p=0.017), no difference in death rates (p=0.10), but an increased risk of endovascular revascularisation (aHR 1.21, 95% CI: 1.06-1.39; p<0.01) at 1 year. The use of atherectomy during PVI is common and is not associated with an increase in IH adverse events. Longitudinally, patients treated with atherectomy undergo repeat endovascular reintervention more frequently but experience a reduced risk of amputation and surgical revascularisation.

Outcomes and Costs of Lower Extremity Peripheral Vascular Interventions With Intravascular Ultrasound

Outcomes and Costs of Lower Extremity Peripheral Vascular Interventions With Intravascular Ultrasound

Oral factor Xa inhibitor underutilization following lower extremity peripheral vascular intervention

ObjectivePatients undergoing peripheral vascular intervention (PVI) (ie, endovascular revascularization) for symptomatic lower extremity peripheral artery disease remain at high risk for major adverse limb and cardiovascular events. High-quality evidence demonstrates the addition of a low-dose oral factor Xa inhibitor to single antiplatelet therapy, termed dual pathway inhibition (DPI), reduces the incidence of major adverse events in this population. This study aims to describe the longitudinal trends in factor Xa inhibitor initiation after PVI, identify patient and procedural characteristics associated with factor Xa inhibitor use, and describe temporal trends in antithrombic therapy post-PVI before vs after VOYAGER PAD. MethodsThis retrospective cross-sectional study was performed using data from the Vascular Quality Initiative PVI registry from January 2018 through June 2022. Multivariate logistic regression was utilized to determine predictors of factor Xa inhibitor initiation following PVI, reported as odds ratios (ORs) with 95% confidence intervals (CIs). ResultsA total of 91,569 PVI procedures were deemed potentially eligible for factor Xa inhibitor initiation and were included in this analysis. Overall rates of factor Xa inhibitor initiation after PVI increased from 3.5% in 2018 to 9.1% in 2022 (P < .0001). The strongest positive predictors of factor Xa inhibitor initiation after PVI were non-elective (OR, 4.36; 95% CI, 4.06-4.68; P < .0001) or emergent (OR, 8.20; 95% CI, 7.14-9.41; P < .0001) status. The strongest negative predictor was postoperative dual antiplatelet therapy prescription (OR, 0.20; 95% CI, 0.17-0.23; P < .0001), highlighting significant hesitation about use of DPI after PVI and limited translation of VOYAGER PAD findings into clinical practice. Antiplatelet medications remain the most common antithrombotic regimen after PVI, with almost 70% of subjects discharged on dual antiplatelet therapy and approximately 20% discharged on single antiplatelet therapy. ConclusionsFactor Xa inhibitor initiation after PVI has increased in recent years, although the absolute rate remains low, and most eligible patients are not prescribed this treatment.

Value-Based Interventions for Lower Extremity Peripheral Vascular Interventions

Each year at the Society for Cardiovascular Angiography & Interventions (SCAI) Annual Scientific Sessions meeting, collaborative Think Tanks involving interventional cardiologists, administrative partners, and members of industry are convened for each SCAI clinical practice area to discuss topics of particular interest to the group. This document presents the proceeding of the 2022 peripheral session, which focused on value-based peripheral vascular interventions (PVI).

How much flow is enough: the use of fractional flow reserve in chronic limb-threatening ischemia in a series of patients with isolated occlusive tibial disease

The role of the fractional flow reserve to guide lower extremity peripheral vascular intervention, specifically in chronic limb-threatening ischemia, has remained unclear. This series presents a novel use of the fractional flow reserve in four patients to guide lower extremity endovascular interventions in patients with chronic limb-threatening ischemia.

Sex-Based Differences in Periprocedural Complications Following Lower Extremity Peripheral Vascular Intervention.

Women with coronary artery disease are shown to have worse outcomes after percutaneous coronary intervention compared with men; however, less is known about sex-based outcomes following lower extremity peripheral vascular intervention (PVI) for symptomatic peripheral artery disease. The study aims to assess whether female sex is independently associated with periprocedural complications in patients undergoing PVI. Analysis includes patients undergoing lower extremity PVI from September 2016 to March 2020 from the Vascular Quality Initiative registry. Multivariate logistic regression was used to assess the independent association of female sex with post-PVI complications. Of the 119 620 patients included, 47 316 (39.6%) were women. Analysis reflected that women were at higher risk of developing access site complications, including any hematoma (odds ratio [OR], 1.45 [1.35-1.57]), hematoma requiring transfusion (OR, 2.24 [1.82-2.76]; P<0.001), hematoma requiring surgery (OR, 1.49 [1.19-1.86]; P<0.001), pseudoaneurysm (OR, 1.69 [1.39-2.05]; P<0.001), and access site occlusion (OR, 1.89 [1.15-3.08]; P<0.001). Women also faced higher risks of target lesion dissection (OR, 1.36 [1.26-1.46]; P<0.001), above-knee amputation (OR, 1.37 [1.18-1.58]; P<0.001), and in-hospital mortality (OR, 1.21 [1.07-1.38]; P=0.003). In a contemporary cohort, women undergoing lower extremity PVI for symptomatic peripheral artery disease were at higher risk than men of developing periprocedural complications, including moderate or severe access site bleeding, above-knee amputation, and in-hospital mortality. This increased risk persisted despite adjustment for differences in baseline patient or procedural characteristics and warrants further investigation.

SA54 Validating the Clinical Utility of Intravascular Ultrasound Guidance during Lower-Extremity Peripheral Vascular Interventions Using Claims Data in Japan from 2009-2020: A Real-World Evidence Study Protocol

Although the clinical utility of intravascular ultrasound (IVUS)-guidance during lower-extreme peripheral vascular interventions (LE-PVI) is well-established, there remains a paucity of long-term outcomes data among patients with peripheral arterial disease (PAD) in Asia. Current evidence suggest that IVUS-use significantly reduces the short-term incidence of vascular complications and major limb events. This study investigates the long-term comparative clinical effectiveness of IVUS-guidance during LE-PVI using real-world evidence (RWE) from Japan, where IVUS has been separately and non-discriminatorily reimbursed since 1994.

Overutilization of Atherectomy in Ambulatory and Office Based Centers

Atherectomy use has become increasingly prevalent in lower extremity peripheral vascular intervention (PVI), particularly in ambulatory and office based centers. Our goal was to quantify atherectomy use by site of service using a contemporary real world dataset.

D-16 | Validating the Clinical Utility of Intravascular Ultrasound Guidance During Lower-extremity Peripheral Vascular Interventions Using Claims Data in Japan from 2009-2020: A Real-world Study

While the clinical utility of intravascular ultrasound (IVUS)-guidance during lower-extreme peripheral vascular interventions (LE-PVI) is well-established, there remains a paucity of long-term outcomes data among Asian patients with peripheral arterial disease (PAD). This study sought to investigate the long-term clinical effectiveness of IVUS-guidance during LE-PVI using hospital claims data from Japan, where IVUS has been separately and non-discriminatorily reimbursed since 1994.

Transradial peripheral vascular intervention using Fowler\u2019s position and Terumo R2P system for patients with heart failure: two case reports

BackgroundPositioning a patient on the catheterization table is important for proper cardiac or respiratory function during peripheral vascular interventions. Fowler’s position, where the patient’s head is a 45° angle, is more effective in reducing venous blood volume returning to the heart from the periphery compared with the supine position. The Terumo R2P system has been developed for transradial peripheral vascular interventions.Case presentationTwo patients with heart failure (a 75-year-old Japanese female and a 74-year-old Japanese male) underwent lower-extremity peripheral vascular interventions in Fowler’s position to prevent worsening heart failure. Because their head position was opposite the C-arm of the X-ray machine, the left radial artery was selected as the access site. The Terumo R2P system was used for transradial peripheral vascular intervention. We successfully treated superficial artery diseases with long shaft balloons and rapid-exchange Terumo R2P Misago stents.ConclusionsAlthough lower-extremity peripheral vascular intervention using Fowler’s position and the Terumo R2P system has several limitations, including device availability and technical complexity, it may be effective for particular patients who have higher risk of worsening heart failure in the supine position.

Use of Intravascular Ultrasound During First-Time Femoropopliteal Peripheral Vascular Interventions Among Medicare Beneficiaries

Intravascular ultrasound (IVUS) may be a useful adjunct to lower extremity peripheral vascular interventions (PVI) in certain clinical scenarios. We aimed to identify patient- and physician-level characteristics associated with the use of IVUS during first-time femoropopliteal PVI. We included all Medicare beneficiaries undergoing elective femoropopliteal PVI for claudication or chronic limb-threatening ischemia between 01/01/2019 and 12/31/2019. We excluded patients with prior open or endovascular femoropopliteal intervention and all physicians performing ≤10 PVI during the study period. We calculated the proportion of patients who had IVUS performed as part of their index PVI for each physician. Hierarchical logistic regression was used to evaluate patient- and physician-level factors associated with use of IVUS. We identified 58,552 patients who underwent index femoropopliteal PVI, of whom 11,394 (19%) received IVUS. A total of 1,628 physicians performed >10 procedures during the study period, with IVUS utilization ranging from 0-100%. After hierarchical regression, claudication (versus chronic limb-threatening ischemia: OR 1.23, 95% CI 1.11-1.36), stenting (versus angioplasty alone: OR 1.57, 1.33-1.86) and atherectomy (versus angioplasty alone: OR 2.09, 1.83-2.39) were associated with higher odds of IVUS utilization. Higher-volume providers (tertile 3 vs. tertile 1: OR 3.78, 2.43-5.90) and those with high rates of service provided in an office-based laboratory (tertile 3 vs. tertile 1: OR 10.72, 6.78-19.93) were more likely to utilize IVUS. Radiologists (OR 11.23, 5.96-21.17) and cardiologists (OR 1.97, 1.32-2.93) used IVUS more frequently than vascular surgeons. Wide variability exists in the use of IVUS for first-time femoropopliteal PVI. The association of IVUS with claudication, atherectomy, and office-based laboratories raises concern about its potential overuse by some physicians.

Use Of Intravascular Ultrasound During First-time Femoropopliteal Peripheral Vascular Interventions Among Medicare Beneficiaries

Intravascular ultrasound (IVUS) may be a useful adjunct to lower extremity peripheral vascular interventions (PVI) in certain clinical scenarios. We aimed to identify patient- and physician-level characteristics associated with the use of IVUS during first-time femoropopliteal PVI.

Institutional Red Blood Cell Transfusion Rates Are Correlated Following Endovascular and Surgical Cardiovascular Procedures: Evidence That Local Culture Influences Transfusion Decisions.

BackgroundThe relationship between local hospital culture and transfusion rates following endovascular and surgical cardiovascular procedures has not been well studied.Methods and ResultsPatients undergoing coronary revascularization, aortic valve replacement, lower extremity peripheral vascular intervention, or carotid artery revascularization from up to 852 US hospitals in the Nationwide Readmissions Database were identified. Crude and risk‐standardized red blood cell transfusion rates were determined for each procedure. Pearson correlation coefficients were calculated between respective procedural transfusion rates. Median odds ratios were estimated to reflect between‐hospital variability in red blood cell transfusion rates following the same procedure for a given patient. There was wide variation in red blood cell transfusion rates across different procedures, from 2% following carotid endarterectomy to 29% following surgical aortic valve replacement. For surgical and endovascular modalities, transfusion rates at the same hospital were highly correlated for aortic valve replacement (r=0.67; P<0.001), moderately correlated for coronary revascularization (r=0.56; P<0.001) and peripheral vascular intervention (r=0.51; P<0.001), and weakly correlated for carotid artery revascularization (r=0.19, P<0.001). Median odds ratios were all >2, highest for coronary artery bypass graft surgery and surgical aortic valve replacement, indicating substantial site variation in transfusion rates.ConclusionsAfter adjustment for patient‐related factors, wide variation in red blood cell transfusion rates remained across surgical and endovascular procedures employed for the same cardiovascular condition. Transfusion rates following these procedures are highly correlated at individual hospitals and vary widely across hospitals. In aggregate, these findings suggest that local institutional culture significantly influences the decision to transfuse following invasive cardiovascular procedures and highlight the need for randomized data to inform such decisions.

The Use of Embolic Protection Devices during Lower Extremity Peripheral Vascular Interventions

The use of embolic protection device (EPD) during lower extremity peripheral vascular interventions (PVI) has been reported, but its impact on outcomes is unclear. The goal of this study was to assess the use and outcomes of EPDs during PVI. All PVI between 2010 and 2014 in the Vascular Study Group of New England (VSGNE) database were reviewed. The characteristics of patients and lesions treated with EPD were identified. A propensity-matched control group without EPD was selected. The outcomes of both groups were compared, and a multivariable analysis was performed. There were a total of 10,875 procedures. EPD was used in 2% of the procedures. From 2010 to 2014, EPD use significantly increased from 1.1 to 3.5% (P<0.001). Patients undergoing PVI with EPD were less likely to be white but more likely to have diabetes, chronic obstructive pulmonary disease, coronary artery disease, and history of prior PVI. After propensity matching, there were 182 procedures with EPD and 604 controls with no significant difference in risk factors. There was no difference in indication or anatomic level treated, with claudication (52.7% vs. 49.8%) being most common indication and the superficial femoral artery (65.4% vs. 62.1%), the most commonly treated artery. Patients undergoing PVI with EPD were more likely to be treated with excisional atherectomy (26.4% vs. 12.6%), whereas patients without EPD were more likely to be treated with orbital atherectomy (31.9% vs. 41.6%, P=0.017). There was no significant difference in the incidence of minor distal embolization (DE) (1.1% vs. 1.5%) or DE requiring endovascular treatment (2.8% vs. 2.6%) between the two groups, but EPD use was significantly associated with increased fluoroscopy time (P<0.001). There was no difference in technical success, patency, amputation, or mortality between the two groups. On multivariable analysis, there was no significant association between the use of EPD and patency (incidence relative risk (IRR) [95% CI]=1.1 [0.9-1.3]), amputation (IRR=0.7 [0.2-2.1]), or mortality (IRR=0.8 [0.6-1.2]). However, there was a significant difference in fluoroscopy time (mean ratio [95% CI]=1.2 [1.1-1.3]). The analysis was repeated after eliminating all procedures with DE in the EPD group (assuming that EPD use is 100% effective in preventing DE), and the results were no different. EPD use during PVI has significantly increased. Despite EPDs increasing procedural complexity and time, they do not seem to have any impact on PVI outcomes. Additional studies are needed to characterize which patients would benefit from EPDs.

Differences in risk factors and resource utilization for women undergoing percutaneous coronary intervention and lower extremity peripheral vascular intervention.

To investigate the differences in risk factors and in-hospital outcomes for women undergoing percutaneous coronary intervention (PCI) and peripheral vascular intervention (PVI). The clinical impact of coronary artery disease (CAD) and peripheral artery disease (PAD) is well characterized and is associated with high morbidity and mortality. There is lack of data comparing risk factors and in-hospital outcomes for PCI and PVI, particularly in women. Only female hospitalizations (age ≥ 18 years) who underwent PCI or PVI from 2005 to 2014 were identified using appropriate International Classification of Diseases-Ninth Revision, Clinical Modification codes from the National Inpatient Sample database. Charlson's Comorbidity Index (CCI) was selected as the primary endpoint of the study. Coprimary endpoint was the cost of hospitalizations associated with PCI or PVI. Of the 2,461,328 female hospitalizations that were included, 85.6% (N = 2,105,236) underwent PCI and 14.4% (N = 356,092) received PVI. Compared to PCI, PVI hospitalizations were 3.2 years older (p < .001) and consisted of significantly more hospitalizations above 80 years of age (26.5% vs. 18.6%; p < .001). Hospitalizations with CCI ≥3 were significantly higher in the PVI cohort (29.1% vs. 24%; p < .001). CCI in women increased during the study period for both groups. PVI hospitalizations had a significantly longer length of stay (3 days vs. 2 days; p < .001) and cost of hospitalization ($23,610 vs. $20,571; p < .001), compared to PCI. Finally, the mean cost of hospitalizations increased during the study period for PCI and PVI. Women hospitalized for PVI had a greater risk-profile and resource utilization as demonstrated by the longer length of stay and higher cost compared to PCI.

Expanding opportunities to understand quality and outcomes of peripheral vascular interventions: The ACC NCDR PVI Registry

Lower extremity peripheral artery disease (PAD) and cerebrovascular disease (CeVD) are prevalent conditions in the United States, and both are associated with significant morbidity (eg, stroke, myocardial infarction, and limb loss) and increased mortality. With a growth in invasive procedures for PAD and CeVD, this demands a more clear responsibility and introduces an opportunity to study how patients are treated and evaluate associated outcomes. The American College of Cardiology (ACC) National Cardiovascular Data Registry (NCDR) Peripheral Vascular Intervention (PVI) Registry is a prospective, independent collection of data elements from individual patients at participating centers, and it is a natural extension of the already robust NCDR infrastructure. As of September 20, 2018, data have been collected on 45,316 lower extremity PVIs, 12,417 carotid artery stenting procedures, and 11,027 carotid endarterectomy procedures at 208 centers in the United States. The purpose of the present report is to describe the patient and procedural characteristics of the overall cohort and the methods used to design and implement the registry. In collecting these data, ACC and ACC PVI Registry have the opportunity to play a pivotal role in scientific evidence generation, medical device surveillance, and creation of best practices for PVI and carotid artery revascularization.

Bleeding Complications in Lower-Extremity Peripheral Vascular Interventions: Insights From the NCDR PVI Registry

ObjectivesThis study sought to assess periprocedural bleeding complications in lower-extremity peripheral vascular interventions (PVIs). BackgroundFew studies have examined the incidence, predictors, or outcomes of periprocedural bleeding after lower-extremity PVI. MethodsThe study examined patients undergoing PVI at 76 hospitals in the National Cardiovascular Data Registry PVI registry from 2014 to 2016. Post-PVI major bleeding was defined as any overt bleeding with a hemoglobin (Hb) drop of ≥3 g/dl, any Hb decline of ≥4 g/dl, or blood transfusion in patients with pre-procedure Hb >8 g/dl within 72 h of their procedure. Hierarchical multivariable logistic regression was used to identify factors independently associated with post-PVI bleeding. The study also examined adjusted in-hospital mortality among patients with or without major bleeding complications. ResultsAmong 18,289 PVI procedures, major bleeding occurred in 744 (4.10%). Patient characteristics independently associated with bleeding included age, female sex, heart failure, pre-procedural hemoglobin <12 g/dl, nonelective PVI, and critical limb ischemia on presentation. Procedural characteristics associated with bleeding included nonfemoral vascular access, use of thrombolytic therapy, PVI of the aortoiliac segment, and multilesion interventions, whereas use of closure devices was associated with less bleeding. All-cause in-hospital mortality was higher in patients who experienced bleeding than in those who did not (6.60% vs. 0.30%; p < 0.001; adjusted hazard ratio: 10.9; 95% confidence interval: 6.9 to 17.0). ConclusionsMajor bleeding occurred in 4.10% of lower-extremity PVI procedures and was associated with several patient and procedural characteristics, as well as in-hospital mortality. These insights can be incorporated into strategies to reduce periprocedural bleeding after PVI.

TCT-59 Prevalence, predictors and outcomes of bleeding complications in peripheral vascular interventions for lower extremities: Insights from the NCDR PVI registry

Peri-procedure PCI bleeding is associated with increased mortality and is potentially preventable, but few studies have examined bleeding complications in lower extremity peripheral vascular interventions (PVI).We examined the prevalence of major bleeding, patient characteristics associated with

UTILIZATION OF DISTAL EMBOLIC PROTECTION IN INFRAINGUINAL PERIPHERAL ARTERIAL INTERVENTION: INSIGHTS FROM THE MULTICENTER XLPAD REGISTRY

Background: Distal embolization (DE) is a serious complication of lower extremity peripheral vascular interventions (PVI). Although, embolic protection devices (EPD) mitigate the risk of DE, there is a paucity of data on the use of EPDs during PVI. Methods: We analyzed data from the multicenter