Clinician perspectives regarding CYP2C19 genotype testing in patients with critical limb ischemia: A Delphi approach.

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.

A state-of-the-art review of quality-of-life assessment in venous disease.

OBJECTIVE: Chronic venous disease is a common condition and has a significant impact on patients' health status. Validated patient-reported outcome measures (PROMs) used to assess health status are needed to measure health status. This state-of-the-art review summarizes the current validation evidence for disease-specific PROMs for chronic venous disease and provides a framework for their use in the clinical setting. METHODS: A literature search in OVID Embase and Medline was conducted to identify relevant English-language studies of chronic venous disease that used disease-specific PROMs between January 1, 1993, and June 30, 2022. Abstracts and titles from identified studies were screened by four investigators, and full-text articles were subsequently screened for eligibility. Data on validation of disease-specific PROMs was abstracted from each included article. Classical test theory was used as a framework to examine a priori defined validation criteria for content validity, reliability (construct validity, internal reliability, and test-retest reliability), responsiveness, and expansion of the validation evidence base (use in randomized controlled trials and comparative effectiveness research, cultural or linguistic translations, predictive validity, or establishing the minimal clinically important difference threshold, defined as smallest amount an outcome or measure is perceived as a meaningful change to patients). The PROMs were categorized into three groups based on the manifestations of disease of the population for which they were developed. The overall validity of each PROM was assessed across three stages of validation including content validity (phase 1); construct validity, reliability, and responsiveness (phase 2); and expansion of the validation evidence base (phase 3). RESULTS: Of 2338 unique studies screened, 112 studies (4.8%) met inclusion criteria. The eight disease-specific PROMs identified were categorized into three groups: (1) overall chronic venous disease (C1 to C6); (2) C1 to C4 disease; and (3) C5 to C6 disease. Assessed by group, the Chronic Venous Insufficiency Questionnaire met criteria for validation at all three phases for patients with C1 to C4 disease, and the Charing Cross Venous Ulcer Questionnaire met criteria for validation at all three phases for patients with C5 to C6 disease. There were no PROMs that met all criteria for validation for use in overall chronic venous disease (C1 to C6). CONCLUSIONS: Of the eight PROMs assessed in this review, only two met prespecified criteria at each phase for validation. The Chronic Venous Insufficiency Questionnaire and Charing Cross Venous Ulcer Questionnaire should be considered for use in patients with chronic venous disease without venous ulcers and with venous ulcers, respectively.

The Pulsating Stent Sign in May-Thurner Syndrome.

PURPOSE: To report a case of a patient with May-Thurner syndrome who underwent endovenous stenting and was found to have pulsating arterial compression on the venous stent. REPORT: A 74-year-old man presented with 18 months of progressive right thigh and calf edema. After an extensive work-up, the patient underwent a venogram with intravascular ultrasound (IVUS), revealing compression of the right iliac vein by the external iliac artery and psoas muscle. Following stent deployment, fluoroscopy revealed extrinsic compression by an artery, but IVUS confirmed sufficient stent expansion. On follow-up, there was a significant resolution of right limb edema, and adjacent arterial pulsation/compression was deemed non-significant. CONCLUSION: The choice of venous stents is essential to prevent collapse from extrinsic compression, such as that from an adjacent artery. CLINICAL IMPACT: Carefully choosing venous stents is essential to ensure stent patency in the face of external compression.

Comparative Analysis of Mortality and Amputation Rates in Patients Undergoing Atherectomy for Infra-Popliteal Peripheral Arterial Disease: Insight From the VQI.

INTRODUCTION: Infra-popliteal peripheral arterial disease (IPPAD) poses challenges due to high restenosis and occlusion rates. The BASIL-2 trial demonstrated the superiority of endovascular treatment compared with surgical bypass in patients with IPPAD. However, the association between different endovascular modalities and clinical outcomes has not been conclusive. HYPOTHESIS: Combining plain old balloon angioplasty (POBA) with atherectomy is associated with improved clinical outcomes compared with POBA alone. METHODS: Patients who underwent POBA vs POBA+atherectomy for IPPAD from the Vascular Quality Initiative database were identified. To mitigate potential selection bias, we employed propensity score matching (PSM) to balance the distribution of confounding variables for mortality identified on multivariable logistic regression. Subsequently, we compared patient characteristics and long-term outcomes between the 2 treatment groups. RESULTS: Among patients who underwent endovascular intervention for IPPAD, 19 979 individuals (80.8%) were treated with POBA alone, while 4747 (19.2%) were treated with both POBA+atherectomy after PSM. Propensity score matching ensured minimal differences in baseline characteristics, such as indication for lower extremity revascularization (LER) and history of LER. After PSM, patients receiving POBA+atherectomy experienced higher rates of technical success and lower perioperative complications, such as renal complications and hematoma, compared with POBA alone. During long-term follow-up, patients who underwent atherectomy had lower rates of major amputation and major adverse limb events (MALE) but slightly lower freedom from reintervention. Nonetheless, there were no differences in mortality. CONCLUSION: Combining POBA with atherectomy appears to be a safe approach in patients with IPPAD, with lower rates of long-term amputation and MALE at the cost of a higher risk of reintervention. CLINICAL IMPACT: The use of adjunctive atherectomy is associated with improved long-term outcomes in patients with infra-popliteal disease.

Obesity and Peripheral Artery Disease: Current Evidence and Controversies.

PURPOSE OF REVIEW: Obesity is a significant public health problem and a major risk factor for the development and progression of atherosclerosis and its cardiovascular manifestations. Lower extremity peripheral artery disease (PAD) affects 3%-10% of the Western population and, if left untreated, can lead to devastating outcomes with both an increased risk of morbidity and mortality. Interestingly, the association between obesity and PAD remains debatable. Whereas it is well known that PAD and obesity frequently overlap in the same patients, many studies have demonstrated a negative association between obesity and PAD and a protective effect of obesity on disease development and progression, a phenomenon described as the "obesity paradox." Possible mechanisms for this paradox may include genetic background, as assessed by mendelian randomization studies, adipose tissue dysfunction, and body fat distribution rather than adiposity, while other factors, such as sex, ethnicity, sarcopenia in the elderly population, or aggressive treatment of co-existing metabolic conditions in individuals with obesity compared to those with normal weight, could have some impact as well. RECENT RINDINGS: Few reviews and meta-analyses examining systematically the relationship between obesity and PAD exist. The impact of PAD development due to the presence of obesity remains largely controversial. However, the most current evidence, backed by a recent meta-analysis, suggests a potential protective role of a higher body mass index on PAD-related complications and mortality. In this review, we discuss the association between obesity and PAD development, progression, and management, and the potential pathophysiologic mechanisms linking the two diseases.

Complex pathologies in a patient referred for varicose veins.

Varicose veins are commonly due to saphenous vein reflux, but they can manifest more complex venous pathologies. A 45-year-old woman presented with painful leg varicosities and pelvic pain. Duplex examination showed bilateral superficial venous reflux, and, on further interrogation, cross-sectional imaging demonstrated enlarged ovarian veins and nonthrombotic iliac vein compression. Ovarian vein embolization followed by iliac vein stenting and bilateral lower extremity venous ablations and sclerotherapy was performed. After 5 years, she reports no pelvic symptoms and minimal leg symptoms. This case highlights the complex interplay of these venous pathologies and their successful treatment.

Correlation between reflux time and venous clinical severity score in patients undergoing saphenous vein ablation: A prospective study.

OBJECTIVES: It is unclear whether reflux time independently correlates with severity of symptoms in patients with great saphenous vein reflux. METHODS: Eighty patients (mean age 64+/-12.7 years, 56% female) undergoing great saphenous vein (GSV) ablation for symptomatic reflux were assessed prospectively. Fifty-seven underwent ablation with radiofrequency, 23 with cyanoacrylate adhesive. Venous clinical severity score (VCSS) was assessed at, or prior to the time of ablation. The highest reflux time in the GSV was selected. RESULTS: VCSS values ranged from 2 to 20 (median 7). Mean reflux time was 5.3 s (+/-3.3). The Spearman rank correlation yielded a value of rs = -0.123, p (2-tailed) = .279, which was not significant. The patients with concomitant deep vein reflux had higher VCSS (p < .05). Analysis of patients with only superficial vein reflux (n = 45) also demonstrated a poor correlation between VCSS and reflux time (rs = -0.051, p (2-tailed) = .741). CONCLUSION: This prospective study did not demonstrate a correlation between reflux time and VCSS.

Management of Post-thrombotic Syndrome: A Comprehensive Review.

BACKGROUND: Post-thrombotic syndrome (PTS) is the most common long-term complication of acute deep venous thrombosis (DVT). The cumulative incidence of PTS in the first two years after the first acute DVT diagnosis approximates 25%. OBJECTIVE: This study aims to summarize the most recent updates and provide a comprehensive review of the current management of PTS. METHODS: We searched MEDLINE/PMC/NCBI Bookshelf (PubMed), Cochrane, Embase, Scopus, ClinicalTrials, and OpenGrey databases for relevant articles in English published from the establishment of each separate database until February 9, 2021. CONCLUSION: PTS constitutes the most frequent long-term complication of lower limb deep venous thrombosis (DVT). Lifestyle changes and compression treatment represent an integral part of PTS management and have a clear benefit to offer in PTS patients. Pharmacological treatment with phlebotonic and non-phlebotonic medications, such as micronized purified flavonoid fraction (MMPF) and sulodexide, respectively, may have a more central and significant role in PTS management than previously thought. The introduction of percutaneous transluminal venoplasty (PTV) and stenting has again raised our expectations with the field, along with new concerns and considerations. There is a growing number of studies that report promising results on patientoriented outcomes on PTS patients who were treated with PTV and stenting. Moreover, hybrid (endovascular/ surgical) interventions may also represent a safe and efficacious treatment option for a subset of patients with PTS. Patient selection criteria for endovascular and hybrid interventional treatment should be carefully set and standardized. Post-operative care after venoplasty is an important field of future research with potential clinical impact. Management of deep and superficial reflux remains controversial. Hopefully, future prospective studies shall provide more robust evidence on the management of PTS.

Development and validation of a predictive model for bleeding after peripheral vascular intervention: A report from the National Cardiovascular Data Registry Peripheral Vascular Interventions Registry.

OBJECTIVES: To develop a model to predict risk of in-hospital bleeding following endovascular peripheral vascular intervention. BACKGROUND: Peri-procedural bleeding is a common, potentially preventable complication of catheter-based peripheral vascular procedures and is associated with increased mortality. We used the National Cardiovascular Data Registry (NCDR) Peripheral Vascular Interventions (PVI) Registry to develop a novel risk-prediction model to identify patients who may derive the greatest benefit from application of strategies to prevent bleeding. METHODS: We examined all patients undergoing lower extremity PVI at 76 NCDR PVI hospitals from 2014 to 2017. Patients with acute limb ischemia (n = 1600) were excluded. Major bleeding was defined as overt bleeding with a hemoglobin (Hb) drop of ≥ 3 g/dl, any Hb decline of ≥ 4 g/dl, or a blood transfusion in patients with pre-procedure Hb ≥ 8 g/dl. Hierarchical multivariable logistic regression was used to develop a risk model to predict major bleeding. Model validation was performed using 1000 bootstrapped replicates of the population after sampling with replacement. RESULTS: Among 25,382 eligible patients, 1017 (4.0%) developed major bleeding. Predictors of bleeding included age, female sex, critical limb ischemia, non-femoral access, prior heart failure, and pre-procedure hemoglobin. The model demonstrated good discrimination (optimism corrected c-statistic = 0.67), calibration (corrected slope = 0.98, intercept of -0.04) and range of predicted risk (1%-18%). CONCLUSIONS: Post-procedural PVI bleeding risk can be predicted based upon pre- and peri-procedural patient characteristics. Further studies are needed to determine whether this model can be utilized to improve procedural safety through developing and targeting bleeding avoidance strategies.

Correlation between great saphenous length of treatment zone and diameter with improvement in symptoms after ablation.

OBJECTIVE: The aim of the present study was to examine the relationship between the great saphenous vein (GSV) length of segment ablated and diameter with symptom improvement. METHODS: Data from a multicenter, randomized, controlled prospective study of 242 patients undergoing radiofrequency ablation (RFA) or cyanoacrylate closure (CAC) of the GSV were analyzed. The venous clinical severity score (VCSS) was measured at baseline and at 1, 3, 6, 12, 24, and 36 months after ablation. The GSV diameter was evaluated for a correlation with VCSS at each time point. Using the median treatment length of 34 cm, the patients were divided into group I (treatment length ≥34 cm) vs group II (<34 cm) for analysis. The pretreatment VCSS and VCSS improvement (ΔVCSS) after treatment were evaluated with respect to the length of the ablated GSV segment. The postablation VCSS was compared between the pretreatment GSV diameters of <5.5 mm vs ≥5.5 mm. RESULTS: The mean GSV length ablated by RFA was 35.3 ± 14 cm vs 32.6 ± 11 cm with CAC (P = NS). No significant difference was found in the VCSS (at baseline or follow-up) between RFA and CAC. The pooled data for all participants (n = 242) demonstrated a correlation between the treated GSV length and pretreatment VCSS and the ΔVCSS at 36 months (R = 0.23; P < .001). Greater VCSS improvement was seen in group I (≥34 cm ablated) than in group II (<34 cm ablated) at ≤36 months of follow-up (P = .003). At baseline, group I had had higher VCSSs (6.21 ± 2.75 vs 4.88 ± 2.33; P < .00001) and CEAP (clinical, etiologic, anatomic, pathophysiologic) and reflux scores. Of the 242 patients, 101 had had a GSV diameter <5.5 mm and 141 had had a GSV diameter of ≥5.5 mm. No significant differences were noted in the VCSSs, either at baseline or at follow-up, between the two groups. Within the study population, a poor correlation was found between the GSV diameter and baseline VCSS (R = -0.004; P = .95) and between the GSV diameter and ΔVCSS for ≤36 months (R = 0.04; P = .55). CONCLUSIONS: Longer segments of GSV reflux appeared to correlate with symptom severity. We found a small to moderate correlation between the length of GSV segment ablated and symptom improvement. This might reflect the greater severity of symptoms at baseline in patients with longer segments with reflux. We found a poor correlation between the proximal GSV diameter and symptom improvement after ablation.

Safety and efficacy outcomes of the Pioneer Plus catheter in endovascular revascularization of lower extremity chronic total occlusions.

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.

Correlation of venous symptoms with iliac vein stenosis on magnetic resonance imaging.

OBJECTIVE: Magnetic resonance imaging (MRI) is used in patients with lower extremity venous disease to screen for iliac vein stenosis. The objective of the present study was to determine the prevalence of iliac vein stenosis and associated lower extremity venous symptoms in consecutive patients undergoing MRI of the pelvis. METHODS: A retrospective study of all consecutive adult patients who had undergone MRI of the pelvis for various indications from March 2012 to June 2016 was performed. The electronic medical records (EMRs) were reviewed for patient characteristics and, specifically, for the presence and laterality of venous symptoms. All MRI scans were reviewed, and the maximal degree of iliac vein stenosis was recorded. All the patients also responded to a brief telephone survey inquiring about the presence of venous symptoms. Two thresholds of venous stenosis, ≥50% and ≥70%, were used to correlate its presence with the presence of venous symptoms determined from the EMR review and telephone survey results. RESULTS: A total of 120 patients were included, with a mean age of 53 ± 14 years; 79% were women and 79% were white. The prevalence of iliac vein stenosis ≥50% was significantly greater on the left than on the right (34.2% vs 16.7%; P < .001). The survey demonstrated that 44 of the 120 patients (36.7%) had had venous symptoms compared with only 30 patients (25%) according to the EMR review (P = .001). No differences were found between patients with positive vs negative survey results for venous symptoms and the occurrence of iliac vein stenosis ≥50% on the right (17.2% vs 15.2%; P = .78) or the left (38% vs 26.8%; P = .22). We also found no differences when the occurrence of iliac vein stenosis ≥70% was used as threshold between the right (2.3% vs 3%; P = .99) and the left (10.1% vs 2.4%; P = .16). Analysis of the venous symptoms from the EMR review yielded similar results. CONCLUSIONS: In our study, iliac vein stenosis was more common on the left and was encountered in up to one third of patients who had undergone MRI of the pelvis. No correlation was found in our study between the presence of iliac vein stenosis and the occurrence of ipsilateral venous symptoms. Venous symptoms were underreported in the EMRs. Further studies are necessary to identify the predictors of pathologic iliac vein stenosis.

Mechanical Circulatory Support to Treat Pulmonary Embolism: Venoarterial Extracorporeal Membrane Oxygenation and Right Ventricular Assist Devices.

Mechanical circulatory support may help patients with massive pulmonary embolism who are not candidates for systemic thrombolysis, pulmonary embolectomy, or catheter-directed therapy, or in whom these established interventions have failed. Little published literature covers this topic, which led us to compare outcomes of patients whose massive pulmonary embolism was managed with the use of venoarterial extracorporeal membrane oxygenation (VA-ECMO) or a right ventricular assist device (RVAD). We searched the medical literature from January 1990 through September 2018 for reports of adults hospitalized for massive or high-risk pulmonary embolism complicated by hemodynamic instability, and who underwent VA-ECMO therapy or RVAD placement. Primary outcomes included weaning from mechanical circulatory support and discharge from the hospital. We found 16 reports that included 181 patients (164 VA-ECMO and 17 RVAD). All RVAD recipients were successfully weaned from support, as were 122 (74%) of the VA-ECMO patients. Sixteen (94%) of the RVAD patients were discharged from the hospital, as were 120 (73%) of the VA-ECMO patients. Of note, the 8 RVAD patients who had an Impella RP System were all weaned and discharged. For patients with massive pulmonary embolism who are not candidates for conventional interventions or whose conditions are refractory, mechanical circulatory support in the form of RVAD placement or ECMO may be considered. Larger comparative studies are needed.

Impact of the COVID-19 pandemic on interventional cardiology training in the United States.

OBJECTIVES: We sought to determine the effect of COVID-19 related reduction in elective cardiac procedures and acute coronary syndrome presentations on interventional cardiology (IC) training. BACKGROUND: The COVID-19 pandemic has significantly disrupted healthcare in the United States, including cardiovascular services. The impact of COVID-19 on IC fellow training in the United States has not been assessed. METHODS: The Society for Cardiovascular Angiography and Interventions (SCAI) surveyed IC fellows training in both accredited and advanced non-accredited programs, as well as their program directors (PD). RESULTS: Responses were received from 135 IC fellows and 152 PD. All respondents noted reductions in procedural volumes beginning in March 2020. At that time, only 43% of IC fellows had performed >250 PCI. If restrictions were lifted by May 15, 2020 78% of IC fellows believed they would perform >250 PCI, but fell to only 70% if restrictions persisted until the end of the academic year. 49% of IC fellows felt that their procedural competency was impaired by COVID-19, while 97% of PD believed that IC fellows would be procedurally competent at the end of their training. Most IC fellows (65%) noted increased stress at work and at home, and many felt that job searches and/or existing offers were adversely affected by the pandemic. CONCLUSION: The COVID-19 pandemic has substantially affected IC training in the United States, with many fellows at risk of not satisfying current program procedural requirements. These observations support a move to review current IC program requirements and develop mitigation strategies to supplement gaps in education related to reduced procedural volume.

Utility of Intravascular Ultrasound in Peripheral Vascular Interventions: Systematic Review and Meta-Analysis.

OBJECTIVES: We sought to compare outcomes between intravascular ultrasound- (IVUS) versus angiography (AO)-guided peripheral vascular interventions (PVIs). Introduction: Intravascular ultrasound facilitates plaque visualization and angioplasty during PVIs for peripheral arterial disease. It is unclear whether IVUS may improve the durability of PVIs and lead to improved clinical outcomes. METHODS: This is a study-level meta-analysis of observational studies. The primary end points of this study were rates of primary patency and reintervention. Secondary end points included rates of vascular complications, periprocedural adverse events, amputations, technical success, all-cause mortality, and myocardial infarction. RESULTS: Eight observational studies were included in this analysis with 93 551 patients. Mean follow-up was 24.2 ± 15 months. Intravascular ultrasound-guided PVIs had similar patency rates when compared with AO-guided PVIs (relative risk [RR]: 1.30, 95% confidence interval [CI]: 0.99-1.71, P = .062). There was no difference in rates of reintervention in IVUS-guided PVIs when compared to non-IVUS-guided PVIs (RR: 0.41, 95% CI: 0.15-1.13, P = .085). There is a lower risk of periprocedural adverse events (RR: 0.81, 95% CI: 0.70-0.94, P = .006) and vascular complications (RR: 0.81, 95% CI: 0.68-0.96, P = .013) in the IVUS group. All-cause mortality (RR: 0.76, 95% CI: 0.56-1.04, P = .084), amputation rates (RR 0.83, 95% CI: 0.32-2.15, P = .705), myocardial infarctions (RR: 1.19, 95% CI: 0.58-2.41, P = .637), and technical success (RR: 1.01, 95% CI: 0.86-1.19, P = .886) were similar between the groups. Conclusions: Intravascular ultrasound-guided PVIs had similar primary patency and reintervention when compared with AO-guided PVIs with significantly lower rates of periprocedural adverse events and vascular complications in the IVUS-guided group.

Safety of compression therapy for venous ulcer disease in the setting of congestive heart failure.

OBJECTIVES: Compression therapy is the mainstay of treatment for patients with venous ulcer disease. There exists a lack of certainty as to the safety of compression therapy in patients with congestive heart failure. METHODS: A retrospective review of 95 patients with the diagnosis of congestive heart failure (systolic, diastolic, or combined), who underwent compression therapy at the wound care center of a large teaching hospital between January 2013 and June 2019, was performed. Patient outcomes including mortality, weight gain, admission for heart failure decompensation, and requirement for diuretic dose increase were compared to the general congestive heart failure population as well as to the registry data. RESULTS: In the compression cohort, with a mean compression period of 310 days, seven patients (7.3%) were admitted for congestive heart failure exacerbation and six (6.3%) underwent diuretic dosage increase. Two patients (2.1%) died during the compression period. These endpoints were not significantly higher than within the general congestive heart failure population. CONCLUSIONS: Compression therapy appears safe amongst patients with stable congestive heart failure.

Perioperative Outcomes of Lower Extremity Revascularization for Rest Pain and Tissue Loss.

BACKGROUND: Critical limb ischemia (CLI) is the clinical manifestation of severe peripheral artery disease presenting as rest pain (RP) and tissue loss (TL). Most studies compare CLI as a homogenous group with claudication with limited database studies specifically studying these differences. We hypothesize that CLI should be stratified into RP and TL because of significant differences in disease severity, comorbidities, and outcomes. METHODS: The American College of Surgeons National Surgical Quality Improvement Program database from 2012 to 2016 was reviewed. All patients with a postoperative diagnosis of CLI undergoing femoral to popliteal bypass (FPB) with vein or graft were identified. Patients were stratified into cohorts based on International Classification of Disease (ICD)-9 or ICD-10 codes for RP or TL (gangrene or ulcer). Univariate and multivariate analyses were performed to examine 30-day mortality, morbidity, major amputation, and readmission adjusting for demographics, comorbidities, and procedural details. RESULTS: There were 5,304 patients. Compared to RP, patients with TL were older (P < 0.0001) and more likely to be dependent (P < 0.0001). TL patients were also more likely to have diabetes (P < 0.0001), congestive heart failure (P < 0.0001), renal failure (P = 0.004), dialysis (P < 0.0001), history of wound infection (P < 0.0001), and sepsis (P < 0.0001). TL patients had higher American Society of Anesthesiologists class (P < 0.0001), were less likely to be transferred from home (P < 0.0001), and more likely to receive an FPB with vein (P = 0.03). Patients with TL had worse perioperative outcomes compared with RP in terms of pneumonia (P = 0.004), unplanned intubation (P = 0.009), cardiac arrest requiring cardiopulmonary resuscitation (P = 0.003), bleeding requiring transfusions (P < 0.0001), sepsis (P < 0.0001), septic shock (P = 0.02), and reoperation (P < 0.0001). TL was associated with significantly higher 30-day morbidity (P < 0.0001), 30-day mortality (P < 0.0001), major amputation (P = 0.0004), and readmission rates (P = 0.005). Patients with TL compared with those with RP also had longer hospital stays (P < 0.0001) and days between operation to discharge (P < 0.0001). TL was independently associated with increased 30-day morbidity (OR: 1.16 [1.00-1.35]) and major amputation (OR: 2.48 [1.29-4.76]) compared with RP. CONCLUSIONS: Patients with RP and TL have drastic differences that impact perioperative mortality and readmissions. TL is an independent predictor of 30-day morbidity and major amputation. The stratification of CLI into RP and TL can provide insight into variations in outcomes and provide a means to quantify the risks associated with the 2 manifestations of the disease.

Financial barriers in accessing medical care for peripheral artery disease are associated with delay of presentation and adverse health status outcomes in the United States.

Patient-reported difficulties in affording health care and their association with health status outcomes in peripheral artery disease (PAD) have never been studied. We sought to determine whether financial barriers affected PAD symptoms at presentation, treatment patterns, and patient-reported health status in the year following presentation. A total of 797 United States (US) patients with PAD were identified from the Patient-centered Outcomes Related to TReatment Practices in Peripheral Arterial Disease: Investigating Trajectories (PORTRAIT) study, a prospective, multicenter registry of patients presenting to vascular specialty clinics with PAD. Financial barriers were defined as a composite of no insurance and underinsurance. Disease-specific health status was measured by Peripheral Artery Questionnaire (PAQ) and general health-related quality of life was measured by EuroQol 5 (EQ5D) dimensions at presentation and at 3, 6, and 12 months of follow-up. Among 797 US patients, 21% (n = 165) of patients reported financial barriers. Patients with financial barriers presented at an earlier age (64 ± 9.5 vs 70 ± 9.4 years), with longer duration of symptoms (59% vs 49%) (all p ⩽ 0.05), were more depressed and had higher levels of perceived stress and anxiety. After multivariable adjustment, health status was worse at presentation in patients with financial barriers (PAQ: -7.0 [-10.7, -3.4]; p < 0.001 and EQ5D: -9.2 [-12.74, -5.8]; p < 0.001) as well as through 12 months of follow-up (PAQ: -8.4 [-13.0, -3.8]; p < 0.001 and EQ5D: -9.7 [-13.2, -6.2]; p < 0.001). In conclusion, financial barriers are associated with later presentation as well as poorer health status at presentation and at 12 months. ClinicalTrials.gov Identifier: NCT01419080.

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.

Evaluation of anticoagulant and antiplatelet therapy after iliocaval stenting: Factors associated with stent occlusion.

OBJECTIVE: Iliocaval stenting has gained increased use over recent years for a variety of indications, including May-Thurner syndrome (MTS), post-thrombotic syndrome (PTS), and acute deep vein thrombosis (DVT). METHODS: A retrospective review of 155 patients undergoing iliocaval venous stenting at a large teaching hospital was performed. Clinical and procedural data, mode and duration of anticoagulation or antiplatelet therapy, and outcomes were recorded. RESULTS: Forty-five patients were treated for MTS, 49 for PTS. and 61 for acute DVT. The median follow-up was 19 months (interquartile range, 9-30 months). Primary patency rates were 97.8% in the MTS group, 85.7% in PTS, and 85.2% for the acute DVT group. Stent restenosis or occlusion occurred in one patient with MTS (2.2%), seven patients with PTS (14%), and nine patients with acute DVT (15%). An ipsilateral DVT recurred in 7 patients with PTS (14%) and 15 patients with acute DVT (25%). The stents that occluded had a tendency toward longer length (162.2 vs 125.2 mm; P = NS) and extension into the common femoral vein (18.8 vs 5.3%; P = NS). The patent stent group had statistically larger nominal diameter stents (P = .013). The duration of anticoagulation did not seem to be a significant factor in stent patency. CONCLUSIONS: Stent diameter has a significant influence on iliocaval stent patency rates.