Peripheral Vascular Interventions Research Articles

Short-and long-term clinical impact of intravascular ultrasound-guided endovascular treatment for patients with peripheral artery disease

Abstract Background Intravascular ultrasound (IVUS) has become a standard procedure in coronary intervention, but it is unclear whether IVUS usage improves procedural success rate or prognosis in patients with peripheral endovascular therapy (EVT). Methods This study analyzed more than 2,000 consecutive patients from the TOkyo-taMA peripheral vascular intervention research COmraDE (TOMA-CODE) registry that prospectively enrolled consecutive patients with peripheral arterial disease (PAD) in 34 hospitals in Japan from August 2014 to August 2016. The primary outcome is adverse cardiac and cerebrovascular events (MACCE) and limb events including clinical target lesion revascularization (cTLR) and amputation in the median follow-up period of 10.4 month after the first EVT. The secondary outcomes are procedural success rate and major adverse limb events (MALE) in hospital setting. Every analysis was also conducted with adjusted model after propensity score matching. Results In enrolled 2,227 eligible cases, we compared the MACCE and limb events between 784 cases with IVUS usage and 1443 patients without IVUS usage during EVT procedure. There was no significant difference of MACCE and limb events between with and without IVUS usage during EVT procedure over 2 years. However, EVT procedure with IVUS usage contributed significantly higher procedural success rate than that without IVUS usage (98.5% vs 96.7%, p=0.02). Moreover, EVT procedure with IVUS usage contributed less MALE (1.6% vs 4.1%, p=0.02) in hospital setting than that without IVUS usage after propensity score matching. Especially, unscheduled revascularization rate in hospital was less in EVT procedure with IVUS usage than that without IVUS usage (1.5% vs 3.7%, p=0.01). Conclusion IVUS usage for EVT did not improve MACCE or limb events over 2-years. However, IVUS usage improved procedural success rate and contributed less MALE when limited to the period of hospitalization. IVUS usage could be recommended for EVT procedures.Table

Abstract 18246: Determining the Most Important Factors for 1-year Health Status Using a Machine-Learning Algorithm in Patients With Peripheral Artery Disease Undergoing Revascularization for Claudication

Introduction: Over time, patients with peripheral artery disease (PAD) are at high risk of poor cardiovascular outcomes, but most immediately, their health status is impacted due to lifestyle-limiting symptoms. To improve functioning, peripheral vascular intervention (PVI) may be offered. We aimed to understand which factors predict subsequent health status outcomes following PVI. Methods: We used data from the international ILLUMENATE examining the safety of peripheral angioplasty with vs. without Stellarex drug-coated balloon for femoropopliteal artery disease in randomized trial between 2013 and 2019. Treatment arms were combined for this analysis. EQ-5D 3L Index and Visual Analog Scale (VAS) were assessed at baseline and 1 year. Random forest regression, a base-trees machine-learning algorithm, was built in the training sample (80% of the cohort) and evaluated in the validation sample (20% of the cohort). The importance of 58 included pre-procedural variables was ranked. The most important variables were defined based on visual inspection of the relative importance plots to evaluate the information gained value of each included variable. Results: In the 473 included patients, the mean age was 68.2 ± 9.2 years, 32.1% were female and 4.2% were Black. For the 1-year 3L Index, the most important pre-procedural variables were liver disease and the 3L Index (54.1%). For the 1-year VAS, the most important variables were angioplasty/drug eluting stent following by chronic lung disease (94.9%), mechanical thrombectomy (81.0%), anticoagulant (80.1%) and congestive heart failure (76.5%). (Figure) Conclusions: As part of an effort to develop an individualized health status profile with machine learning, a predictable ranking of pre-procedural variables can inform 1-year health status outcomes in patients with PAD undergoing PVI for claudication. These approaches can inform clinical decision-making and pre-habilitation efforts to maximize treatment success.

Abstract 18259: Overestimation of Major Amputation Risk in Patients Undergoing Peripheral Vascular Intervention for Peripheral Artery Disease When Not Accounting for Mortality Risk

Background: Endovascular peripheral vascular intervention (PVI) is intended to improve symptoms and functioning, and avoid limb amputation in patients with chronic limb threatening ischemia (CLTI). CLTI is associated with high mortality risk, which differs across age groups. We aimed to offset mortality vs. amputation risks by age groups in patients with CLTI using competing risk modeling. Methods: Patients with CLTI underwent PVI in 2017-2018 in the Vascular Quality Initiative registry were included. Mortality and major amputation outcomes over 3 years were derived from Medicare data. The cumulative incidence (CIF) of both outcomes in age groups <65 and ≥65 years, was calculated by Aalen-Johansen (AJ), taking mortality into account, and compared with corresponding CIF calculated by Kaplan-Meier (KM). The major amputation risk in <65 vs ≥65 years was estimated using a Fine and Gray competing risk model (sHR) and Cox regression (HR) adjusted for patients’ baseline characteristics. Results: A total of 10,114 patients were included: 22% <65 years; 59% male and 19% Black. The cumulative incidence of death without major amputation increased with age (32% in <65 vs. 46% ≥65 years) and was higher than that of major amputation (26% in <65 vs. 15% in ≥65 years). By ignoring competing risk, both death without major amputation and major amputation was overestimated by a relative difference of 25.4% and 14.3% in <65 years and by 13.8% and 21.2% in ≥65 years. The adjusted major amputation risk in <65 vs. ≥65 years estimated by Cox regression was HR 1.30 95%CI 1.16-1.56 vs. FG model sHR = 1.75 95%CI 1.57-1.95. (Table) Conclusions: Longer term mortality following PVI is high, especially among elderly with CLTI. To derive accurate risk estimates for amputation across age groups, advanced methods that can accommodate the competing risk of mortality are needed to better inform clinicians and patients as they face CLTI treatment decisions.

Abstract 16870: Short-Term Risk Prognostication for All-Cause Mortality After Endovascular Revascularization in the Medicare Claims-Linked VQI Registry

Background: Patients with chronic limb-threatening ischemia (CLTI) have high mortality rates after revascularization. Balancing short-term mortality risk against limb salvage gains is important when triaging patients with CLTI to revascularization. Data for risk stratification is limited. We aimed to develop machine learning models to rank predictive variables for 30-day and 90-day all-cause mortality for CLTI after peripheral vascular intervention (PVI). Methods: Patients undergoing PVI for CLTI between 2017 and 2018 in the Medicare-linked Vascular Quality Initiative (VQI) were included. Sixty-six preprocedural variables were included in random survival forest (RSF) models. RSF models were constructed for 30-day and 90-day all-cause mortality in the training sample (80% of data) and evaluated in the validation sample (20% of data). Predictive variables were ranked based on frequency that they caused branch splitting nearest the root node. Goodness of fit was assessed by Harrell’s C-index. Results: A total of 10,114 patients (mean age 72 ± 11, 59% male, 74% white) were included. The mortality rate was 4.4% at 30 days and 10.6% at 90 days. The RSF model for 30-day mortality identified stage 5 chronic kidney disease (CKD), dementia, and urgent procedures as the most predictive variables. For the 90-day mortality prediction model, the most important variables were stage 5 CKD, dementia, and poor functional status (Figure) . For both models, 8 of the top 10 variables were either medical history or functional status variables. The C-index was 0.72 for the 30-day model and 0.73 for the 90-day model. Conclusion Using data from the claims-linked VQI registry, medical comorbidities and functional status variables were identified as the most predictive variables for 30-day and 90-day all-cause mortality using RSF models. Results may help guide individualized risk conversations regarding PVI versus conservative therapy for the highest risk patients.

Abstract 16867: Predictors of Long-Term Mortality in Chronic Limb Threatening Ischemia Derived From a Random Forest Machine-Learning Model

Introduction: Optimizing limb survival in patients with chronic limb-threatening ischemia (CLTI) undergoing peripheral vascular intervention (PVI) is a major focus. Care plans that consider patients’ high-mortality risk are less common. Understanding which patients have the highest mortality risk would enable more personalized care plan designs to enable person-centered care. We aimed to leverage a random forest machine learning (RFML) model to predict long-term mortality in patients with CLTI undergoing PVI. Methods: A cohort of patients with CLTI undergoing PVI from 2017 to 2019 from the Medicare linked Vascular Quality Initiative registry was derived. Using 89 pre-procedural variables, we constructed a RFML model predicting 3-year mortality. Missing data were addressed by random forest imputation. The data were divided into a training sample (80%) and a test sample (20%) using random sampling without replacement comprising. Variables that most frequently caused branch splitting closest to the tree′s origin of were defined as the most predictive factors, with a total of 1,000 trees being built. Accuracy was assessed using the Continuous Ranked Probability Score (CRPS) and Harrell’s C-index. Results: A total of 10,114 patients were included (mean age 72 ± 11 years, 59% male, 74% white). The 3-year mortality rate was 39.1% (Median survival: IQR: ), Among the 15 most predictive variables, 14 variables are potentially modifiable, Remarkably, 5 functional or psychiatric variables were among the most predictive factors. CRPS and Harrerl′s C-index were 0.172 and 0.70, respectively. Conclusion: Our RFML model successfully predicted 3-year all-cause mortality in patients with CLTI undergoing PVI. Predictors of mortality in CLTI extend beyond medical history and encompass functional and behavioral variables. A shared decision-making individualized plan focusing on patient-centered care is needed to improve long-term mortality in patients with CLTI.

The CathPilot: Performance Validation and Preclinical Safety and Feasibility Assessment.

Peripheral endovascular revascularization procedures often fail due to technical limitations of guidewire support, steering, and visualization. The novel CathPilot catheter aims to address these challenges. This study assesses the safety and feasibility of the CathPilot and compares its performance to conventional catheters for peripheral vascular interventions. The study compared the CathPilot to non-steerable and steerable catheters. The success rates and access times for a relevant target inside a tortuous vessel phantom model were assessed. The reachable workspace within the vessel and the guidewire's force delivery capabilities were also evaluated. To validate the technology, chronic total occlusion tissue samples were used ex vivo to compare crossing success rates with conventional catheters. Finally, in vivo experiments in a porcine aorta were conducted to evaluate safety and feasibility. The success rates for reaching the set targets were 31%, 69%, and 100% with the non-steerable catheter, the steerable catheter, and the CathPilot, respectively. CathPilot had a significantly larger reachable workspace, and allowed for up to four times higher force delivery and pushability. In crossing of chronic total occlusion samples, the CathPilot achieved a success rate of 83% and 100%, for fresh and fixed lesions respectively, which was also significantly higher than conventional catheters. The device was fully functional in the in vivo study, and there were no signs of coagulation or damage to the vessel wall. This study shows the safety and feasibility of the CathPilot system and its potential to reduce failure and complication rates in peripheral vascular interventions. The novel catheter outperformed conventional catheters in all defined metrics. This technology can potentially improve the success rate and outcome of peripheral endovascular revascularization procedures.

Arterial dissection during peripheral vascular interventions

ObjectiveArterial dissection (AD) is a known complication of peripheral vascular interventions (PVIs), but its incidence and significance have not been well-characterized. This study examines AD in the Vascular Quality Initiative database for patients treated for peripheral arterial disease. Our hypothesis is that AD is associated with decreased patency and worse limb outcomes. MethodsThe Vascular Quality Initiative PVI registry (2016-2021) was reviewed. Patients were divided based on the presence or absence of reported AD during the procedure. Trend of incidence and management of AD was derived. The characteristics and outcomes of patients with and without AD were compared. The primary endpoint was primary patency. ResultsThere was a total of 177,790 cases, and 3% had AD. The incidence of AD significantly increased over the study period from 2.4% to 3.6% (P = .007). Endovascular therapy was used to treat AD in 83.7% of cases, 14.5% were treated medically, and only 1.8% required open surgery. Patients with AD were significantly more likely to be female (47.4% vs 39.7%; P < .001). Patient with AD were more likely to have a history of smoking (79.7% vs 77.2%; P < .001), but were significantly less likely to be on dialysis (8.2% vs 9.3%; P < .001) compared with patients without AD. Patients with AD were more likely to have femoropopliteal disease (45.2% vs 38.0%; P < .001) and undergo treatment of more complex disease as denoted by higher mean number of lesions treated (1.95 ± 1.01 vs 1.71 ± 0.89; P < .001), longer occlusion length (8 ± 16 vs 7 ± 15 cm; P < .001), and more severe TransAtlantic Inter-Society Consensus grade (Grade D: 36.2% vs 29.1%; P < .001). The proportion of stenting as a treatment modality was higher in the dissection group (55.4% vs 41.1%; P < .001). After a mean follow-up of 828 days, patients with AD had significantly lower primary patency than patients without AD. Kaplan-Meier curves demonstrated that the AD group had lower primary patency (86.9% vs 91%; P < .001) and reintervention-free survival (79.5 % vs 84.1%; P < .001) at 1 year with difference in amputation-free survival. Cox proportional hazard regression confirmed the independent association of AD with primary patency and reintervention-free survival. ConclusionsAD is more common in women and is more likely to occur during treatment of the femoropopliteal segment. AD is associated with decreased primary patency and reintervention-free survival after PVI for peripheral arterial disease.

Outcomes of lower extremity revascularization in octogenarians and nonagenarians for intermittent claudication

ObjectiveRevascularization for intermittent claudication (IC) due to infrainguinal peripheral arterial disease (PAD) is dependent on durability and expected benefit. We aimed to assess outcomes for IC interventions in octogenarians and nonagenarians (age ≥80 years) and those younger than 80 years (age <80 years). MethodsThe Vascular Quality Initiative was queried (2010-2020) for peripheral vascular interventions (PVIs) and infrainguinal bypasses (IIBs) performed to treat IC. Baseline characteristics, procedural details, and outcomes were analyzed (comparing age ≥80 years and age <80 years). ResultsThere were 84,210 PVIs (12.1% age ≥80 years and 87.9% age <80 years) and 10,980 IIBs (7.4% age ≥80 years and 92.6% age <80 years) for IC. For PVI, patients aged ≥80 years more often underwent femoropopliteal (70.7% vs 58.1%) and infrapopliteal (19% vs 9.3%) interventions, and less often iliac interventions (32.1% vs 48%) (P < .001 for all). Patients aged ≥80 years had more perioperative hematomas (3.5% vs 2.4%) and 30-day mortality (0.9% vs 0.4%) (P < .001). At 1-year post-intervention, the age ≥80 years cohort had fewer independently ambulatory patients (80% vs 91.5%; P < .001). Kaplan-Meier analysis showed patients aged ≥80 years had lower reintervention/amputation-free survival (81.4% vs 86.8%), amputation-free survival (87.1% vs 94.1%), and survival (92.3% vs 96.8%) (P < .001) at 1-year after PVI. Risk adjusted analysis showed that age ≥80 years was associated with higher reintervention/amputation/death (hazard ratio [HR], 1.22; 95% confidence interval [CI], 1.1-1.35), amputation/death (HR, 1.85; 95% CI, 1.61-2.13), and mortality (HR, 1.92; 95% CI, 1.66-2.23) (P < .001 for all) for PVI. For IIB, patients aged ≥80 years more often had an infrapopliteal target (28.4% vs 19.4%) and had higher 30-day mortality (1.3% vs 0.5%), renal failure (4.1% vs 2.2%), and cardiac complications (5.4% vs 3.1%) (P < .001). At 1 year, the age ≥80 years group had fewer independently ambulatory patients (81.7% vs 88.8%; P = .02). Kaplan-Meier analysis showed that the age ≥80 years cohort had lower reintervention/amputation-free survival (75.7% vs 81.5%), amputation-free survival (86.9% vs 93.9%), and survival (90.4% vs 96.5%) (P < .001 for all). Risk-adjusted analysis showed age ≥80 years was associated with higher amputation/death (HR, 1.68; 95% CI, 1.1-2.54; P = .015) and mortality (HR, 1.85; 95% CI, 1.16-2.93; P = .009), but not reintervention/amputation/death (HR, 1.1; 95% CI, 0.85-1.44; P = .47) after IIB. ConclusionsOctogenarians and nonagenarians have greater perioperative morbidity and long-term ambulatory impairment, limb loss, and mortality after PVI and IIB for claudication. Risks of intervention on elderly patients with claudication should be carefully weighed against the perceived benefits of revascularization. Medical and exercise therapy efforts should be maximized in this population.

Treatment Location Variation for Chronic Limb-Threatening Ischemia in Patients With Kidney Failure

IntroductionEnd-stage kidney disease (ESKD) is an established risk factor for chronic limb-threatening ischemia (CLTI). Procedural location for ESKD patients has not been well described. This study aims to examine variation in index procedural location in ESKD versus non-ESKD patients undergoing peripheral vascular intervention for CLTI and identify preoperative risk factors for tibial interventions. MethodsChronic limb-threatening ischemia (CLTI) patients were identified in the Vascular Quality Initiative (VQI) peripheral vascular intervention dataset. Patient demographics and comorbidities were compared between patients with and without ESKD and those undergoing index tibial versus nontibial interventions. A multivariable logistic regression evaluating risk factors for tibial intervention was conducted. ResultsA total of 23,480 procedures were performed on CLTI patients with 13.6% (n = 3154) with ESKD. End-stage kidney disease (ESKD) patients were younger (66.56 ± 11.68 versus 71.66 ± 12.09 y old, P = 0.019), more often Black (40.6 versus 18.6%, P < 0.001), male (61.2 versus 56.5%, P < 0.001), and diabetic (81.8 versus 60.0%, P < 0.001) than non-ESKD patients. Patients undergoing index tibial interventions had higher rates of ESKD (19.4 versus 10.6%, P < 0.001) and diabetes (73.4 versus 57.5%, P < 0.001) and lower rates of smoking (49.9 versus 73.0%, P < 0.001) than patients with nontibial interventions. ESKD (odds ratio (OR) 1.67, 95% confidence interval (CI) 1.52-1.86, P < 0.001), Black race (OR 1.19, 95% CI 1.09-1.30, P < 0.001), and diabetes (OR 1.82, 95% CI 1.71-2.00, P < 0.001) were risk factors for tibial intervention. ConclusionsPatients with ESKD and CLTI have higher rates of diabetes and tibial disease and lower rates of smoking than non-ESKD patients. Tibial disease was associated with ESKD, diabetes, and Black race.

Noise Audit of Device Selection for Peripheral Vascular Interventions in the Vascular Quality Initiative

Noise Audit of Device Selection for Peripheral Vascular Interventions in the Vascular Quality Initiative

Association between End-Stage Renal Disease and Major Adverse Limb Events after Peripheral Vascular Intervention

PurposeTo examine the effect of end-stage renal disease (ESRD) on the likelihood of major adverse limb events (MALEs) in patients with Rutherford Category 4–6 critical limb ischemia (CLI) who underwent percutaneous vascular intervention (PVI). Materials and MethodsTwo contemporaneous cohorts of patients who underwent PVI for symptomatic CLI from 2012 to 2022, differing in ESRD status, were matched using propensity score methods. This database identified 628 patients who underwent 1,297 lower extremity revascularization procedures; propensity score matching yielded 147 patients (180 limbs, 90 limbs in each group). Kaplan-Meier and Cox proportional hazard analyses were used to assess the effect of ESRD status on MALEs, stratified into major amputation (further stratified into above-knee amputation and below-knee amputation [BKA]) and reintervention (PVI or bypass). ResultsAfter PVI, 31.3% of patients in the matched cohorts experienced a MALE (45.7% ESRD vs 18.2% non-ESRD), and 15.6% experienced a major amputation (27.1% ESRD vs 5.2% non-ESRD). Cox proportional hazards analysis revealed that ESRD was an independent predictor of MALE (hazard ratio [HR], 3.15; 95% CI, 1.58–6.29; P = .001), major amputation (HR, 7.00; 95% CI, 2.06–23.79; P = .002), and BKA (HR, 7.56; 95% CI, 1.71–33.50; P = .008). ConclusionsESRD is strongly predictive of MALE and major amputation risk, specifically BKA, in patients undergoing PVI for Rutherford Category 4–6 CLI. These patients warrant closer follow-up, and new methods may become necessary to predict and further reduce their amputation risk.

Association of End-Stage Renal Disease after Peripheral Vascular Intervention: How Can We Optimize Care?

Association of End-Stage Renal Disease after Peripheral Vascular Intervention: How Can We Optimize Care?

Alternative access for peripheral vascular interventions

Alternative access for peripheral vascular interventions

Assessing the Utility of Toe Arm Index and Toe Pressure in Predicting Wound Healing in Patients Undergoing Vascular Intervention

Objective measures of perfusion such as an ankle-brachial index (ABI) and toe pressure remain important in prognosticating wound healing. However, the use of ABI is limited in patients with incompressible vessels and toe pressure may not be comparable across patients. While a toe arm index (TAI) may be of value in this setting, its role as clinical indicator of perfusion for healing in patients with lower-extremity wounds has not been well established. A retrospective review was performed of all vascular patients with lower-extremity wounds that underwent peripheral vascular intervention between 2014-2019. Data regarding patient demographics, comorbidities, TAI, ABI, toe pressures, and the wound, ischemia, and foot infection (WIfI) score were collected. Associations between patient variables and wound healing at various time points were evaluated. A total of 173 patients (67.7±10.9years; 71.1% male) were identified with lower-extremity wounds. Most patients underwent endovascular intervention (77.5%). Patients were followed for a median of 416 (IQR 129-900) days. Mean postoperative TAI was 0.35±0.19 and mean WIfI score was 2.60±1.17. Nine percent (15) of patients healed within 1month, 44.8% (69) healed within 6months, and 65.5% (97) healed within 1year of revascularization without need for major amputation. Those that healed within 1year without any major amputation did not differ from those that did not heal based on age, gender, race, comorbidities, periprocedural medications, or procedures performed. However, patients that healed without major amputation had a higher postoperative TAI (0.38 vs. 0.30, P=0.02), higher toe pressure (53 vs. 40mm Hg, P=0.004), and lower WIfI score (2.26 vs. 3.12, P<0.001). Patients that healed with 1year without requiring any amputation had similar associations with postoperative TAI, toe pressure, and WIfI. Additionally, they were more likely to be White (P=0.019) and have an open surgical procedure (P<0.001) and less likely to have chronic kidney disease (P=0.001) or diabetes (P=0.008). A Youden index was calculated and identified a TAI value of 0.30 that optimized sensitivity and specificity for wound healing. The area under the curve for TAI as a predictor of wound healing was 0.62. Higher postoperative TAI is associated with higher odds of wound healing without need for major amputation. Toe arm index is therefore a useful tool to identify patients with adequate arterial perfusion to heal lower-extremity wounds. However, the area under the curve is poor for TAI when used as a sole predictor of wound healing potential suggesting that TAI should be one of multiple factors to considered when prognosticating wound healing potential.

Longitudinal outcomes following peripheral vascular intervention among older persons living with HIV.

Persons living with human immunodeficiency virus (HIV, PLWH) have an increased risk of peripheral artery disease (PAD) in comparison to the general population. However, a gap remains in understanding optimal management for this condition. This study assesses longitudinal outcomes associated with peripheral endovascular intervention (PVI) for PAD among PLWH. All Medicare fee-for-service patients undergoing femoropopliteal artery PVI between April 1, 2015 and December 31, 2018 were identified and stratified by HIV serostatus. The primary outcome was major adverse limb events (MALE), defined as major amputation or arterial embolism/thrombosis following an index procedure. The subdistribution hazard was used to evaluate the association between HIV serostatus and MALE, accounting for the competing risk of death. Results were adjusted for sociodemographics and major comorbidities. Of 168,553 patients who underwent PVI, 357 (0.21%) were PLWH. The average age was 77.0 ± 7.6 years; 80.3% had hypertension, 70.3% had hyperlipidemia, and 24.6% had tobacco use disorder. Compared to those without HIV, PLWH were younger and had a higher burden of cardiovascular risk factors. MALE were substantially more frequent among PLWH, with a cumulative incidence of 24.6%, compared to 14.5% among those without HIV. The adjusted subdistribution hazard ratio was 1.26 (95% CI 1.00-1.58, p = 0.05). The use of guideline-directed statin therapy was low in both groups in the 90 days following revascularization (57.9% in PLWH vs 58.1% in those without HIV, p = 0.95). Among US Medicare beneficiaries, PLWH had poorer long-term outcomes following PVI. Greater attention to the management of symptomatic PAD is warranted for the HIV population, particularly following revascularization.

The Vascular Quality Initiative assessment of the Bard Lifestent for the treatment of popliteal artery occlusive disease

ObjectiveThe Bard LifeStent self-expanding stent is approved for the treatment of occlusive disease involving the superficial femoral artery and proximal popliteal artery. We conducted a post-market trial of treatment of the popliteal artery above and below the knee (P1, P2, and P3 segments) within the Society for Vascular Surgery Vascular Quality Initiative (VQI) Peripheral Vascular Intervention registry. MethodsA single-arm, prospective trial was conducted at 29 VQI sites in the United States, enrolling 74 patients from November 2016 to May 2019. The primary safety outcome was freedom from major adverse events including device-/procedure-related mortality and major amputation at 1 year. The primary efficacy outcomes were freedom from target vessel revascularization and freedom from target lesion revascularization at 1 year. Secondary outcomes included lesion success; procedural success; primary, primary-assisted, and secondary patency; and sustained clinical (improvement in Rutherford class) and hemodynamic success (increase in ankle brachial index >0.10). Outcomes were assessed by Kaplan-Meier analysis. Arteriogram of patients undergoing target lesion revascularization were assessed for stent fracture by a core laboratory. ResultsThe mean age was 71 years, with 63.5% male and 55% with diabetes. The indication was claudication 28% and chronic limb-threatening ischemia in 72%. The superficial femoral artery-popliteal artery was stented in 38% and the popliteal artery alone in 62%. The majority of stents were placed in the P1 + P2 (39%) or P1 + P2 + P3 (37%) segments of the popliteal artery. The composite primary endpoint of freedom from major adverse events was 82% and 74% at 1 and 2 years, respectively. Freedom from mortality was 100% and 97%, and freedom from major amputation was 100% and 90% at 1 and 12 months, with all deaths and major amputations occurring in patients with chronic limb-threatening ischemia. freedom from target lesion revascularization was 86%, and freedom from target vessel revascularization was 84% at 12 months. At discharge, lesion treatment success was 99%, and procedural success was 82%. Primary patency was 80% and 72%, primary-assisted patency was 80% and 72%, and secondary patency was 89% and 82% at 12 and 24 months. Sustained clinical success was 98% and 95%, and sustained hemodynamic success was 100% and 79% at 12 and 24 months. ConclusionsIn this multi-center, registry-based, single-arm prospective study the Bard LifeStent self-expanding stent demonstrated favorable performance in the challenging anatomy of the P2 and P3 popliteal segment. Post-market studies for label expansion of peripheral vascular intervention devices can be successfully conducted within the Society for Vascular Surgery VQI registry.

Five Year Survival in Medicare Patients Undergoing Interventions for Peripheral Arterial Disease: a Retrospective Cohort Analysis of Linked Registry Claims Data

To justify upfront risks of offering elective interventions for intermittent claudication (IC), patients should have reasonable life expectancy to derive durable clinical benefits. Open surgery for chronic limb threatening ischaemia (CLTI) is maximally beneficial in patients surviving ≥ 2 years. Our goal was to assess long term survival after IC and CLTI interventions. In a retrospective cohort analysis, the Vascular Quality Initiative (VQI) registry from 1 January 2010 to 31 May 2021 was queried for peripheral vascular intervention (PVI), infra-inguinal bypasses (IIB), and supra-inguinal bypasses (SIB) for IC and CLTI across 286 US centres. VQI linkage to Medicare insurance claims provided 5 year survival data. Multivariable analysis identified factors associated with 5 year mortality. There were 31 457 PVIs (44.7% IC, 55.3% CLTI), 7 978 IIBs (26.9% IC, 73.1% CLTI), and 2 149 SIBs (50.1% IC, 49.9% CLTI) recorded in the VQI. Among PVI, IIB, and SIB cohorts, average ages were 75, 73, and 72 years, respectively. Respective 5 year mortality after PVI for IC and CLTI was 37.2% and 71.1%; after IIB for IC and CLTI it was 37.8% and 60%; and after SIB for IC and CLTI it was 33.8% and 53.8%. On multivariable analysis, across all procedures, end-stage renal disease, CLTI, congestive heart failure, anaemia, chronic obstructive pulmonary disease, and prior amputation were independently associated with increased mortality. Pre-admission home living and pre-operative aspirin use were independently associated with decreased mortality. Long term survival in Medicare patients undergoing interventions in VQI centres for peripheral arterial disease is poor. Two thirds of CLTI patients and over one third of IC patients were not alive at 5 years. Intervening for IC in patients with high mortality risk should be avoided. For CLTI patients identified with decreased survival likelihood, intervention durability may be less important than invasiveness. Pre-operative medical optimisation should always be undertaken.

Consensus minimum core data elements adapted to peripheral vascular intervention in the drug-eluting era: Consensus report from the Registry Assessment of Peripheral Interventional Devices (RAPID) Pathways “LEAN” working group

Registry Assessment of Peripheral Interventional Devices (RAPID) initiated the Pathways Program to provide a transparent, collaborative forum in which to pursue insights into multiple unresolved questions on benefit-risk of paclitaxel-coated devices, including understanding the basis of the mortality signal, without a demonstrable potential biological mechanism, and whether the late mortality signal could be artifact intrinsic to multiple independent prospective randomized data sources that did not prespecify death as a long-term end point. In response to the directive, the LEAN-Case Report Form working group focused on enhancements to the RAPID Phase I Minimum Core Data set through the addition of key clinical modifiers that would be more strongly linked to longer-term mortality outcomes after peripheral arterial disease intervention in the drug-eluting device era, with the goal to have future mortality signals more accurately examined.

Radial access for peripheral vascular intervention: the S.M.A.R.T. RADIANZ Vascular Stent System

ABSTRACT Introduction Radial access is the standard of care for nearly all cardiac catheterization procedures. It improves patient satisfaction, reduces the length of stay, and is associated with fewer complications. However, few devices and tools are available for the treatment of peripheral arterial disease via a transradial approach (TRA). The S.M.A.R.T. RADIANZ Vascular Stent System is among the RADIANZ suite of products, which is aimed at expanding the portfolio of devices to treat peripheral arterial disease. Areas Covered In this Expert review, the following areas will be covered: (1) Current Landscape of peripheral vascular intervention (PVI) using TRA (2) Detailed description of the S.M.A.R.T. RADIANZ Vascular Stent System. (3) Ongoing clinical trials to evaluate safety of this approach. (4) Future directions and current regulatory status. Expert Opinion TRA for PVI is a promising approach. It holds the possibility of substantially improving the care of patients with peripheral arterial disease (PAD). Numerous challenges must be overcome to realize the full potential of a radial-to-peripheral (RTP) approach. The length of devices and the small sheath size are the main constraints of this approach. The results of the ongoing RADIANCY trial will demonstrate the safety, in selected patients, of the RADIANZ suite of products.

Intravascular Ultrasound Guidance During Peripheral Vascular Interventions: Long-term Clinical Outcomes and Costs From the Japanese Perspective.

The value of intravascular ultrasound (IVUS) guidance during peripheral vascular revascularization procedures is incompletely understood. Moreover, data on long-term clinical outcomes and costs are limited. The objective of this study was to compare outcomes and costs between IVUS and contrast angiography alone in patients undergoing peripheral revascularization procedures in Japan. This retrospective comparative analysis was performed using the Japanese Medical Data Vision insurance claims database. All patients undergoing revascularization for peripheral artery disease (PAD) between April 2009 and July 2019 were included. Patients were followed until July 2020, death, or a subsequent revascularization procedure for PAD. Two patient groups were compared: one undergoing IVUS imaging or the other contrast angiography alone. The primary end point was major adverse cardiac and limb events, including all-cause-mortality, endovascular thrombolysis, subsequent revascularization procedures for PAD, stroke, acute myocardial infarction, and major amputations. Total health care costs were documented over the follow-up and compared between groups, using a bootstrap method. The study included 3956 patients in the IVUS group and 5889 in the angiography alone group. Intravascular ultrasound was significantly associated with reduced risk of a subsequent revascularization procedure (adjusted hazard ratio: 0.25 [0.22-0.28]) and major adverse cardiac and limb events (0.69 [0.65-0.73]). The total costs were significantly lower in the IVUS group, with a mean cost saving over follow-up of $18 173 [$7 695-$28 595] per patient. The use of IVUS during peripheral revascularization provides superior long-term clinical outcomes at lower costs compared with contrast angiography alone, warranting wider adoption and fewer barriers to IVUS reimbursement for patients with PAD undergoing routine revascularization. Intravascular ultrasound (IVUS) guidance during peripheral vascular revascularization has been introduced to improve the precision of the procedure. However, questions over the benefit of IVUS in terms of long-term clinical outcome and over cost have limited its use in everyday clinical practice. This study, performed in a Japanese health insurance claims database, demonstrates that use of IVUS provides a superior clinical outcome over the long term at a lower cost compared to angiography alone. These findings should encourage clinicians to use IVUS in routine peripheral vascular revascularization procedures and encourage providers to reduce barriers to use.