BACKGROUND:Peripheral arterial disease is highly prevalent and has a well-established association with diabetes mellitus (DM). However, it remains unclear whether DM worsens clinical outcomes after lower extremity revascularization (LER). METHODS:We performed a systematic search of six databases (Cochrane Library, Embase, Google Scholar, Medline, Scopus, and Web of Science) through February 2024, including studies that reported a risk estimate for the association of DM with 30-day all-cause mortality, hospital readmission, major amputation, and wound infection for patients following LER. For each outcome, a random-effect meta-analysis was applied to pool the relative risk (RR) estimates across studies. I2 statistics were used to examine heterogeneity. RESULTS:Of the 3079 articles screened, 11 observational studies with 139,497 patients were included. A total of 44.8% of patients had DM. DM was associated with an increased risk of 30-day hospital readmission (RR, 1.28; 95% confidence interval (CI), 1.20-1.37; I2 = 28%; P < .001), 30-day major limb amputation (RR, 1.31; 95% CI, 1.14-1.50; I2 = 86%; P < .001), and 30-day wound infection (RR, 1.32; 95% CI, 1.11-1.56; I2 = 81%; P = .001). There was no significant association between DM and 30-day mortality (RR, 1.08; 95% CI, 0.93-1.24; I2 = 65%; P = .33). CONCLUSIONS:Our findings suggest that DM is associated with an increased risk of major amputation, readmission, and wound infection risk, but does not affect mortality risk in patients 30 days after LER.

OBJECTIVES:Antiplatelet therapy is an essential element in the management of patients with arterial vascular disease. In peripheral arterial disease (PAD), dual antiplatelet therapy (DAPT), primarily clopidogrel and aspirin, is routinely prescribed following intervention. There is sparse data regarding the need for DAPT, the appropriate duration, or the heterogeneity of treatment effects for antiplatelet regimens across patients, leading to potential uncertainty and heterogeneity around treatment practices. An example of heterogeneity of treatment effects is a patients' metabolizer status for the use of clopidogrel. The aim of the study was to (1) assess clinicians' knowledge of and attitudes toward managing patients with CYP2C19 mutations, (2) identify barriers to implementation of CYP2C19 testing and management policies, and (3) reach consensus for CYP2C19 testing and management strategies for patients with PAD who undergo peripheral vascular interventions (PVI).METHODS:A modified Delphi method was used to establish consensus amongst PAD interventionalists around CYP2C19 testing. All practicing Yale New Haven Hospital PAD interventionalists with backgrounds in interventional cardiology, vascular surgery, or interventional radiology were approached by email for participation. Round 1 included the collection of baseline demographic questions, knowledge questions, and three statements for consensus. Knowledge questions were rated on a 0-10 Likert scale with the following anchors: 0 ("Not at all"), 5 ("Neutral), and 10 ("Very Much"). Participants were asked to rate the importance of the three consensus statements on a 9-point Likert scale from 1 ("Strongly Disagree") to 10 ("Strongly Agree"). In Round 2, participants were shown the same consensus statements, the median response of the group from the previous round, and their previous answers. Participants were instructed to revise their rating using the results from the previous round. This process was repeated for Round 3.RESULTS:Of the 28 experts invited to participate, 13 agreed (46%). Participants were predominantly male (92.3%) and white (61.5%) with representation from interventional cardiology (46.2%) and vascular surgery (53.8%). Most participants reported more than 10+ years in practice (61.5%). PAD interventionalists felt they would benefit from more education regarding CYP2C19 mutations (median score 8.0, interquartile range 5.0-8.5). They indicated some familiarity with CYP2C19 mutations (7.0, 6.0-9.5) but did not feel strongly that CYP2C19 was important to their practice (6.0, 5.5-7.5). In each round, the median responses for the three consensus statements were 5, 6, and 9, respectively. With each successive round the interquartile range narrowed indicative of evolving consensus but did not reach the prespecified interquartile range for consensus of 1 for any of the statements.CONCLUSIONS:PAD interventionalists practicing at an academic health system recognize the heterogenous response of their patients to clopidogrel therapy but are unsure when to leverage genetic testing to improve outcomes for their patients. Our study identified gaps regarding PAD interventionalists' knowledge, perceived barriers, and attitudes toward CYP2C19 testing in PAD. This information highlights the need for randomized data on genetic testing for clopidogrel responsiveness in peripheral vascular disease following intervention to help guide antiplatelet management.

OBJECTIVE:Endovascular therapy of lower extremity peripheral artery disease (PAD) is associated with higher complication rates and worse outcomes in women vs men. Although intravascular lithotripsy (IVL) has shown similarly favorable outcomes in men and women in calcified coronary arteries, there is no published safety and effectiveness data of peripheral IVL differentiated by sex. This study aims to evaluate sex-specific acute procedural safety and effectiveness following IVL treatment of calcified PAD. METHODS:We performed a secondary analysis of the multicenter Disrupt PAD III Observational Study, which assessed short-term procedural outcomes of patients undergoing treatment of symptomatic calcified lower extremity PAD with the Shockwave peripheral IVL system. Adjudicated acute safety and efficacy outcomes were compared by sex using univariate analysis performed with the χ2 test or Fisher exact test, as appropriate. RESULTS:A total of 1262 patients (29.9% women) were included, with >85% having moderate to severe lesion calcification. Women were older (74 vs 71 years; P < .001), had lower ankle-brachial index (0.7 vs 0.8; P = .003), smaller reference vessel size (5.3 vs 5.6 mm; P = .009), and more severe stenosis at baseline vs men (82.3% vs 79.8%; P = .012). Rates of diabetes, renal insufficiency, chronic limb-threatening ischemia, lesion length, and atherectomy use were similar in both groups. Residual stenosis after IVL alone was significantly reduced in both groups. Final residual stenosis was 21.9% in women and 24.7% in men (P = .001). Serious angiographic complications were infrequent and similar in both groups (1.4% vs 0.6%; P = .21), with no abrupt vessel closure, distal embolization, or thrombotic events during any procedure. CONCLUSIONS:The use of IVL to treat calcified PAD in this observational registry demonstrated favorable acute safety and effectiveness in both women and men.

OBJECTIVE:Comorbid chronic kidney disease (CKD) is associated with worse outcomes for patients with chronic limb-threatening ischemia (CLTI). However, comparative effectiveness data are limited for lower extremity bypass (LEB) vs peripheral vascular intervention (PVI) in patients with CLTI and CKD. We aimed to evaluate (1) 30-day all-cause mortality and amputation and (2) 5-year all-cause mortality and amputation for LEB vs PVI in patients with comorbid CKD. METHODS:Individuals who underwent LEB and PVI were queried from the Vascular Quality Initiative with Medicare claims-linked outcomes data. Propensity scores were calculated using 13 variables, and a 1:1 matching method was used. The mortality risk at 30 days and 5 years in LEB vs PVI by CKD was assessed using Kaplan-Meier and Cox proportional hazards models, with interaction terms added for CKD. For amputation, cumulative incidence functions and Fine-Gray models were used to account for the competing risk of death, with interaction terms for CKD added. RESULTS:Of 4084 patients (2042 per group), the mean age was 71.0 ± 10.8 years, and 69.0% were male. Irrespective of CKD status, 30-day mortality (hazard ratio [HR]: 0.94, 95% confidence interval [CI]: 0.63-1.42, P = .78) was similar for LEB vs PVI, but LEB was associated with a lower risk of 30-day amputation (sub-HR [sHR]: 0.66, 95% CI: 0.44-0.97, P = .04). CKD status, however, did not modify these results. Similarly, LEB vs PVI was associated with a lower risk of 5-year mortality (HR: 0.79, 95% CI: 0.71-0.88, P < .001) but no difference in 5-year amputation (sHR: 1.03, 95% CI: 0.89-1.20, P = .67). CKD status did not modify these results. CONCLUSIONS:Regardless of CKD status, patients had a lower risk of 5-year all-cause mortality and 30-day amputation with LEB vs PVI. Results may help inform preference-sensitive treatment decisions on LEB vs PVI for patients with CLTI and CKD, who may commonly be deemed too high risk for surgery.

INTRODUCTION:Community distress is associated with adverse outcomes in patients with cardiovascular disease; however, its impact on clinical outcomes after peripheral vascular intervention (PVI) is uncertain. The Distressed Communities Index (DCI) is a composite measure of community distress measured at the zip code level. We evaluated the association between community distress, as measured by the DCI, and 24-month mortality and major amputation after PVI. METHODS:We used the Vascular Quality Initiative database, linked with Medicare claims data, to identify patients who underwent initial femoropopliteal PVI between 2017 and 2018. DCI scores were assigned using patient-level zip code data. The primary outcomes were 24-month mortality and major amputation. We used time-dependent receiver operating characteristic curve analysis to determine an optimal DCI value to stratify patients into risk categories for 24-month mortality and major amputation. Mixed Cox regression models were constructed to estimate the association of DCI with 24-month mortality and major amputation. RESULTS:The final cohort consisted of 16,864 patients, of whom 4734 (28.1%) were classified as having high community distress (DCI ≥70). At 24 months, mortality was elevated in patients with high community distress (30.7% vs 29.5%, P = .02), as was major amputation (17.2% vs 13.1%, P <.001). After adjusting for demographic and clinical characteristics, a 10-point higher DCI score was associated with increased risk of mortality (hazard ratio: 1.01; 95% confidence interval: 1.00-1.03) and major amputation (hazard ratio: 1.02; 95% confidence interval: 1.00-1.04). CONCLUSIONS:High community distress is associated with increased risk of mortality and major amputation after PVI.

Patients with lung transplantation can have concomitant left ventricular failure which can either precede the lung transplantation or develop after. Implantable wireless pulmonary artery (PA) pressure monitors to guide hemodynamic management in heart failure such as the CardioMEMS device (Abbott, Sylmar, CA, USA) have been shown to improve outcomes. However, in a lung transplant recipient there are unique physiological and practical considerations when contemplating to implant a PA pressure sensor such as safety of implanting the device, choice of site of implantation, accuracy of wedge tracings to calibrate, and exclusion of vascular stenoses post transplantation. We discuss these considerations in the context of a man in his early 60s with a known left lung transplant two years previously who developed worsening heart failure needing invasive monitoring. Right lung PA sensor placement was considered, but on selective pulmonary angiography the right PA was found to be of small caliber and with significant tortuosity. After careful hemodynamic assessment, the PA sensor was implanted in the PA of the transplanted lung which is the first such case to our knowledge.

Dual antiplatelet therapy (DAPT) is indicated following carotid artery stenting (CAS) and single antiplatelet therapy (SAPT) following carotid endarterectomy (CEA), but it remains unknown how providers adhere to these guidelines in real-world clinical practice. Using the Vascular Quality Initiative New England data, we found that of 12,257 patients, 82% patients were discharged on DAPT following CAS and 66% were discharged on SAPT following CEA. While a high percentage of patients undergoing CAS appropriately receive DAPT, the use of SAPT following CEA exists with more variability and lower adherence rates.

Paclitaxel-coated devices were frequently used for the treatment of femoropopliteal peripheral artery disease (PAD) after the first FDA-approved device came to market at the end of 2012.1 Since then, a series of paclitaxel drugeluting stents (DES) and drug-coated balloons (DCB) have been developed and are currently approved for the treatment of femoropopliteal PAD.1,2 Paclitaxel, a chemotherapeutic agent, prevents neointimal hyperplasia resulting in improved patency and freedom from reintervention when compared with bare metal stents (BMS) and plain balloon angioplasty (POBA).2,3 Despite superior efficacy outcomes, recent events have taken place that may have impacted paclitaxel devices’ widespread use. A first development was the termination of additional payment for DCBs in January of 2018, effectively equalizing payment to the reimbursement level of POBA. Second, in December of 2018, a meta-analysis of randomized controlled trials comparing survival after treatment of the femoropopliteal segment with paclitaxel-coated versus uncoated devices was published and demonstrated a statistically significant increased risk of death at 2 and 5 years postintervention.4 It is unknown how the real-world use of drug-coated devices has evolved over time, and to what degree it has decreased after the occurrence of these two pivotal external events. The Vascular Quality Initiative (VQI) National Database was queried for endovascular femoropopliteal artery interventions performed between 09/2016 and 12/2019 as September of 2016 was the first month DCB and DES were recorded in VQI. Patients with acute limb ischemia and those undergoing open surgery were excluded. This study was approved by the Yale Institutional Review Board. The analysis was done at the artery level to account for multiple lesions treated in a single patient. Treatment of each artery was identified in a hierarchical manner with DCB > DES > BMS > POBA. Two time variables were created to represent the expiration in ambulatory payment classification and the publishing of the Katsanos metaanalysis. These dates were entered in a logistic regression model predicting use versus no use of drug-coated devices (DCB and DES combined). The model was adjusted for patient and lesion characteristics including age, sex, race, ethnicity, primary insurance, hypertension, diabetes mellitus, coronary artery disease, congestive heart failure, chronic kidney disease, preoperative anticoagulation, functional status, treated length, Rutherford category, preoperative ankle– brachial index (ABI), previous intervention on target lesion, and previous intervention on contralateral limb. A total of 62,054 arterial interventions were analyzed among 47,965 unique patients. DES 8.8% (n = 5488), DCB 34.4% (n = 21,352), BMS 27.1% (n = 16,787), and POBA 25.5% (n = 15,832). The mean age was 69.2 ± 11.0 years, 41.5% female, 24.9% non-White, and 6.5% Hispanic. We observed an initial increase in DCB/DES use, which continued to rise despite the ambulatory payment expiration through the end of 2018 when the Katsanos meta-analysis was published (adjusted OR = 1.13, 95% CI 1.05–1.21) (Figure 1A). Trends in drug-coated device use for peripheral artery disease: Insights from the Vascular Quality Initiative (VQI)

BACKGROUND:The VASCADE closure device deploys an extravascular collagen plug. Its use in those with access site disease undergoing peripheral vascular intervention (PVI) is unknown. We aimed to evaluate the efficacy and safety of the VASCADE closure device compared to manual compression (MC) in patients with moderate femoral access site disease.METHODS:We performed a single-center, retrospective review of patients undergoing PVI with at least moderate access site disease. Our institutional database was linked to the Vascular Quality Initiative database, and 200 patients were selected from a 1:1 propensity-matched cohort. Data on procedural metrics and outcomes up to 30-days were abstracted.RESULTS:There were 103 procedures that used VASCADE and 97 used MC. Baseline variables were similar between groups. The mean age was 68.2 ± 11.2 years and 37.6% were women. Closing mean activated clotting time (ACT) was shorter in VASCADE (198 s VASCADE vs. 213 s MC; p = 0.018). There was a nonsignificant decrease in external compression device use with VASCADE (VASCADE 19.0% vs. MC 28.1%; p = 0.15). At 30-days, there was a nonsignificant reduction in hematoma with VASCADE (3.8% vs. 7.8% MC; p = 0.25) and no difference in retroperitoneal bleeding (0.5%). Pseudoaneurysm rate was similar (1.3% VASCADE vs. 1.7% MC; p = 0.79). The 30-day mortality rate was similar between the two groups and not related to the procedure (1.3% VASCADE vs. 0.9% MC; p = 0.79).CONCLUSION:In patients undergoing PVI with at least moderate access site disease, safety and efficacy after using VASCADE was comparable with MC.

Introduction: Peripheral artery disease (PAD) is a chronic disease that requires continuous and individualized disease-management to optimize patients’ symptoms, function and quality of life. Directly capturing patient-reported outcomes (PROs) in routine practice has the potential to increase the patient-centeredness of PAD care. We designed and implemented a system to measure health status within the workflow of a vascular specialty clinic. Methods: In a large academic center, from February 2020 until March 2022, an in-person patient navigation system (Yale PRO-QI) supported by a online data collection workbench was implemented to collect the EQ-5D, Peripheral Artery Questionnaire (PAQ), and VascuQol-6 as part of the outpatient consultations for lower-extremity PAD. Completion rates by month, and domain and summary scores for each PRO were derived per clinical phenotype: new patient/pre-procedural patient, post-procedural/follow-up patient. Results: Of 1071 eligible patient visits, 841 PRO assessments (n=446 unique patients) were completed, for an overall completion rate of 78.5% (monthly completion range 56.4%-100.0%). Patients had a mean age of 70.5±10.2 years, 39.4% were female, 9.6% Hispanics, 14.6% blacks, and 74.7% whites. Of the PROs administered, only the Symptom Stability, Treatment Satisfaction, and Quality of Life subscales of the PAQ were able to discriminate between the clinical phenotypes with differences that reached the minimal clinically important difference threshold of ~10 points ( Figure ). Conclusions: In anticipation of measurement-based care metrics that assess quality of care benchmarks for patient-centered PAD care, our health system integrated PRO workflow had a high response rate, and was able to successfully discriminate between highly symptomatic vs. stable patients as measured by validated disease-specific PRO benchmarks for PAD treatment success.

Introduction: Multi-dimensional assessments of patient reported outcomes (PROs) are becoming increasingly important in optimizing patient-centered care for chronic conditions such as peripheral artery disease (PAD). We aimed to demonstrate the feasibility of a health system integrated workflow to incorporate mental health screenings into the outpatient PAD clinic workflow. Methods: In a large academic center, we administered three validated psychological assessments to consecutive outpatients between March 3, 2021 and July 7, 2021. Assessments were administered as part of an in-person patient navigation system (Yale PRO-QI) and was supported by online data collection. Assessments included the Patient Health Questionnaire-8 (PHQ-8) for depression, the Generalized Anxiety Disorder-7 (GAD-7) for anxiety, and the Perceived Stress Scale-4 (PSS-4) for stress. Validated cutoffs were used to screen for depression and anxiety ( > 10 = depression or anxiety, respectively) and stress (>6 = high stress). Results: There were 104 assessments collected for 98 participants with a mean age of 68.6 + 12.0 years old, 38.8% female, 86.7% White, 9.1% Black and 2.0% Asian or American Indian. The majority (72.5%) were seen for a routine follow-up visit. Two participants (2.0%) screened positive for generalized anxiety disorder. For depression, 12.2% screened positive. Almost half of all participants (47.9%) had higher levels of stress compared with a normative population. There were no statistically significant associations between the risk of positive screening and visit type. Conclusions: Measurement-based care metrics are becoming a standard best practice in routine clinical operations. Psychosocial screening instruments can be integrated in PAD outpatient care and highlight opportunities to improve integrated behavioral care pathways to provide the best care for this vulnerable population.

Background: Critical limb ischemia (CLI), the most severe form of peripheral artery disease, is associated with pain, poor wound healing, high rates of amputation, and mortality (> 20% at 1 year). Little is known about the processes of care, patients' preferences, or outcomes, as seen from patients' perspectives. The SCOPE-CLI study was co-designed with patients to holistically document patient characteristics, treatment preferences, patterns of care, and patient-centered outcomes for CLI. Methods: This 11-center prospective observational registry will enroll and interview 816 patients from multispecialty, interdisciplinary vascular centers in the United States and Australia. Patients will be followed up at 1, 2, 6, and 12 months regarding their psychosocial factors and health status. Hospitalizations, interventions, and outcomes will be captured for 12 months with vital status extending to 5 years. Pilot data were collected between January and July of 2021 from 3 centers. Results: A total of 70 patients have been enrolled. The mean age was 68.4 +/- 11.3 years, 31.4% were female, and 20.0% were African American. Conclusions: SCOPE-CLI is uniquely co-designed with patients who have CLI to capture the care experiences, treatment preferences, and health status outcomes of this vulnerable population and will provide much needed information to understand and address gaps in the quality of CLI care and outcomes.

Objective: Our aim was to evaluate the efficacy and safety outcomes of the Pioneer Plus catheter (Philips, San Diego, Calif) and report the in-hospital and 30-day outcomes of lower extremity chronic total occlusion (CTO) interventions assisted by the Pioneer Plus catheter. In addition, we explored the factors associated with procedural success. Methods: We conducted a retrospective review of 135 consecutive procedures in 116 patients from July 2011 to September 2018 performed by eight operators with various levels of experience at a high-volume center where the Pioneer Plus catheter was used for lower extremity CTO. The patient demographics, preprocedural symptoms, preprocedural testing results, procedural setting, and angiography findings were abstracted. The outcomes were divided into device-related and procedure-related outcomes. Device-related efficacy outcome included procedural success. Device-related safety outcomes included device-related complications. Procedure-related outcomes included procedure-related complications, 30-day major adverse cardiovascular events, and 30-day major adverse limb events. We conducted univariate comparisons of the provider, patient, and procedural characteristics stratified by procedural success. Results: Procedural success was observed in 118 procedures overall (87.4%), and success rates <= 95.8% were observed for operators with an experience level of >25 devices deployed. No device-related complications, such as pseudoaneurysm formation, vessel perforation, or arteriovenous fistula formation, were observed. The Pioneer Plus catheter was mostly often used for CTO in the superficial femoral and popliteal arteries. Overall, the procedure-related complications included access site hematoma (5.2%), major bleeding (0.7%), pseudoaneurysm formation (0.7%), distal embolization (1.5%), and acute arterial thrombosis (1.5%). The 30-day major adverse limb events included index limb unplanned amputation (0.7%), index limb reintervention (4.4%), and index limb acute limb ischemia (0.7%) and occurred in 5.9% of the procedures. The only factor associated with procedural success was operator experience (P < .0001). Conclusions: The results from the present study have shown that Pioneer Plus catheter use is safe and effective when used to cross lower extremity CTO. However, further investigation is needed to identify patient- and provider-level factors to optimize patient outcomes.