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.

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.

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.

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 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.

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.

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

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

Review of the Current Basic Science Strategies to Treat Critical Limb Ischemia.

Critical limb ischemia (CLI) is a highly morbid disease with many patients considered poor surgical candidates. The lack of treatment options for CLI has driven interest in developing molecular therapies within recent years. Through these translational medicine studies in CLI, much has been learned about the pathophysiology of the disease. Here, we present an overview of the macrovascular and microvascular changes that lead to the development of CLI, including impairment of angiogenesis, vasculogenesis, and arteriogenesis. We summarize the randomized clinical controlled trials that have used molecular therapies in CLI, and discuss the novel imaging modalities being developed to assess the efficacy of these therapies.

National and Regional Trends in Deep Vein Thrombosis Hospitalization Rates, Discharge Disposition, and Outcomes for Medicare Beneficiaries.

INTRODUCTION: Older adults are at increased risk of developing deep vein thrombosis. Little is known about national trends of deep vein thrombosis hospitalizations in the context of primary and secondary prevention efforts. METHODS: Medicare standard analytic files were analyzed from 2015-2017 to identify Fee-For-Service patients aged ≥65 years who had a principal discharge diagnosis for deep vein thrombosis from 1999 to 2010. We reported the deep vein thrombosis hospitalization rates per 100,000 person-years as well as 30-day and 1-year mortality rates. We used mixed-effects models to calculate adjusted outcomes. RESULTS: Overall, there were 726,423 deep vein thrombosis hospitalizations in Medicare Fee-for-Service from 1999 to 2010. Deep vein thrombosis hospitalization rate adjusted for age, sex, and race decreased from 264 per 100,000 person-years in 1999 to 167 per 100,000 person-years in 2010, a relative decline of 36.7% (P < .0001). Hospitalizations decreased for all subgroups by age, sex, and race with the exception of black patients (316 to 382 per 100,000 person-years, a relative increase of 20.8%) (P < .0001). Hospital length of stay decreased from 6.1 days in 1999 to 5.0 days in 2010, and the proportion of patients discharged to home decreased from 57.2% to 44.1%. Risk-adjusted 30-day, 6-month, and 1-year mortality and 30-day readmission rates remained relatively stable across the study period, but were highest among women in recent years. CONCLUSIONS: The overall deep vein thrombosis hospitalization rate decreased from 1999 to 2010, except for black patients. Decreases in hospitalizations may reflect changes in clinical practice with increased outpatient rather than inpatient management, and faster transitions to outpatient care for management of deep vein thrombosis.

Latest Innovations in the Treatment of Venous Disease.

Venous disease is more common than peripheral arterial disease. Pathophysiologically, venous disease can be associated with obstruction, reflux, or both. A common feature in chronic venous disease is ambulatory venous hypertension. Inflammatory and pro-thrombotic mechanisms can be activated. The current therapies, including compression, ablation, and recanalization are discussed.

Review of the Latest Percutaneous Devices in Critical Limb Ischemia.

Critical limb ischemia (CLI) is a terminal stage of peripheral arterial disease that, in the absence of intervention, may lead to lower extremity amputation or death. Endovascular interventions have become a first-line approach to the management of CLI and have advanced considerably within the past decade. This review summarizes the types of percutaneous devices and the techniques that are available for the management of CLI and the data supporting their use. These include devices that establish and maintain vessel patency, including percutaneous transluminal angioplasty, drug-coated balloons, bare metal stents, drug-eluting stents, bioresorbable vascular scaffolds, and atherectomy; devices that provide protection from embolization; and, cell-based therapies. Additionally, ongoing trials with important implications for the field are discussed.

A prospective, multi-center study of the chocolate balloon in femoropopliteal peripheral artery disease: The Chocolate BAR registry.

The Chocolate BAR study is a prospective multicenter post-market registry designed to evaluate the safety and performance of the Chocolate percutaneous transluminal angioplasty balloon catheter in a broad population with symptomatic peripheral arterial disease. The primary endpoint is acute procedural success (defined as ≤30% residual stenosis without flow-limiting dissection); secondary long-term outcomes include freedom from target lesion revascularization (TLR), major unplanned amputation, survival, and patency. A total of 262 patients (290 femoropopliteal lesions) were enrolled at 30 US centers between 2012 and 2014. The primary endpoint of procedure success was achieved in 85.1% of cases, and freedom from stenting occurred in 93.1%. Bail out stenting by independent adjudication occurred in 1.6% of cases and there were no flow limiting dissections. There was mean improvement of 2.1 Rutherford classes (±1.5) at 12-months, with 78.5% freedom from TLR, 97.2% freedom from major amputation, and 93.3% freedom from all-cause mortality. Core Lab adjudicated patency was 64.1% at 12 months. Use of the Chocolate balloon in an "all-comers" population achieved excellent procedural outcomes with low dissection rates and bailout stent use.

Compression therapy for venous disease.

For centuries, compression therapy has been utilized to treat venous disease. To date it remains the mainstay of therapy, particularly in more severe forms such as venous ulceration. In addition to mechanisms of benefit, we discuss the evidence behind compression therapy, particularly hosiery, in various forms of venous disease of the lower extremities. We review compression data for stand-alone therapy, post-intervention, as DVT prevention, post-thrombotic syndrome and venous ulcer disease. We also review the data comparing compression modalities as well as the use of compression in mixed arteriovenous disease.

Carotid artery stenting versus carotid endarterectomy.

Stroke remains a significant contributor to morbidity and mortality in developed countries. Carotid artery stenosis is a major cause of stroke. Advances in medical therapy, surgical technique and endovascular maturation has resulted in options for the treatment of carotid stenosis. Here, we present a review of carotid artery stenting and carotid endarterectomy as it applies to trials comparing and contrasting the two treatment options. We also explore the intricacies surrounding reimbursement of these treatment strategies in the USA.

Comparison of Inhospital Outcomes and Hospitalization Costs of Peripheral Angioplasty and Endovascular Stenting.

The comparative data for angioplasty and stenting for treatment of peripheral arterial disease are largely limited to technical factors such as patency rates with sparse data on clinical outcomes like mortality, postprocedural complications, and amputation. The study cohort was derived from the Healthcare Cost and Utilization Project Nationwide Inpatient Sample database from 2006 to 2011. Peripheral endovascular interventions were identified using appropriate International Classification of Diseases, Ninth Revision (ICD-9) Diagnostic and procedural codes. Two-level hierarchical multivariate mixed models were created. The primary outcome includes inhospital mortality, and secondary outcome was a composite of inhospital mortality and postprocedural complications. Amputation was a separate outcome. Hospitalization costs were also assessed. Endovascular stenting (odds ratio, 95% confidence interval, p value) was independently predictive of lower composite end point of inhospital mortality and postprocedural complications compared with angioplasty alone (0.96, 0.91 to 0.99, 0.025) and lower amputation rates (0.56, 0.53 to 0.60, <0.001) with no significant difference in terms of inhospital mortality alone. Multivariate analysis also revealed stenting to be predictive of higher hospitalization costs ($1,516, 95% confidence interval 1,082 to 1,950, p <0.001) compared with angioplasty. In conclusion, endovascular stenting is associated with a lower rate of postprocedural complications, lower amputation rates, and only minimal increase in hospitalization costs compared with angioplasty alone.

Going around the bend: deep inspiration facilitates difficult stent delivery in the native coronary arteries.

Percutaneous coronary intervention in tortuous or calcified vessels poses a substantial challenge for interventional cardiologists. Many techniques have been described to overcome the challenge, including the use of stiffer wires, buddy wires, the anchor balloon technique, and deep seating of the guide catheter. Herein, we describe a way to facilitate stent delivery in many tortuous, calcified, and acutely angled vessels: having the patient take a deep breath during the delivery. Deep inspiration displaces the diaphragm and the heart into a more vertical position and causes the coronary tree to straighten slightly, which facilitates balloon and stent delivery. We have found that this method minimizes patients' radiation exposure and saves substantial time and expense in many balloon and stent deliveries that would otherwise be challenging.