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.

Active smoking is associated with higher rates of incomplete wound healing after endovascular treatment of critical limb ischemia.

The association between active smoking and wound healing in critical limb ischemia (CLI) is unknown. Our objective was to examine in a retrospective cohort study whether active smoking is associated with higher incomplete wound healing rates in patients with CLI undergoing endovascular interventions. Smoking status was assessed at the time of the intervention, comparing active to no active smoking, and also during follow-up visits at 6 and 9 months. Cox regression analysis was conducted to compare the incomplete wound healing rates of the two groups during follow-up. A total of 264 patients (active smokers: n = 41) were included. Active smoking was associated with higher rates of incomplete wound healing in the 6-month univariate Cox regression analysis (hazard ratio (HR) for incomplete wound healing: 4.54; 95% CI: 1.41-14.28; p = 0.012). The 6-month Kaplan-Meier (KM) estimates for incomplete wound healing were 91.1% for the active smoking group versus 66% for the non-current smoking group. Active smoking was also associated with higher rates of incomplete wound healing in the 9-month univariable (HR for incomplete wound healing: 2.32; 95% CI: 1.11-4.76; p = 0.026) and multivariable analysis (HR for incomplete wound healing: 9.09; 95% CI: 1.06-100.0; p = 0.044). The 9-month KM estimates for incomplete wound healing were 75% in the active smoking group versus 54% in the non-active smoking group. In conclusion, active smoking status at the time of intervention in patients with CLI is associated with higher rates of incomplete wound healing during both 6- and 9-month follow-up.

Presence of Contralateral Carotid Occlusion Is Associated With Increased Periprocedural Stroke Risk Following CEA but Not CAS: A Meta-analysis and Meta-regression Analysis of 43 Studies and 96,658 Patients.

Purpose: To investigate the prognostic role of contralateral carotid artery occlusion (CCO) in perioperative outcomes of patients undergoing carotid artery endarterectomy (CEA) vs carotid artery stenting (CAS). Materials and Methods: The PubMed, Scopus, and Cochrane databases were searched up to September 2018 to identify observational or randomized studies that compared outcomes of carotid revascularization in patients with vs without CCO. Forty-three studies (46 arms) comprising 96,658 patients were selected (75,857 CEA and 20,801 CAS). The CCO group included 9258 patients. Heterogeneity was assessed with the Higgins I2 test. I2>75% indicated significant heterogeneity. A random effects model was used to account for heterogeneity among studies. The results were reported as the odds ratios (ORs) with the 95% confidence intervals (CIs). Meta-regression analysis examined potential confounders. Publication bias was quantified by the Egger method. Results: Carotid revascularization in patients with CCO was associated with an increased risk of 30-day mortality (OR 1.75, 95% CI 1.38 to 2.23, p<0.001; I2=0%), stroke (OR 1.77, 95% CI 1.41 to 2.22, p<0.001; I2=46%), transient ischemic attack (TIA) (OR 2.10, 95% CI 1.34 to 3.27, p=0.001; I2=15%), and the composite endpoint of stroke/death (OR 1.78, 95% CI 1.54 to 2.05, p<0.001; I2=0%). No difference was noted in the risk of perioperative myocardial infarction (OR 0.81, 95% CI 0.50 to 1.31; p=0.388; I2=0%). Subgroup analysis demonstrated that CEA in patients with CCO was associated with an increased risk of stroke (OR 2.07, 95% CI 1.72 to 2.49, p<0.001; I2=14%), death (OR 1.80, 95% CI 1.55 to 2.10, p<0.001; I2=0%), TIA (OR 2.18, 95% CI 1.38 to 3.45, p<0.001; I2=13%), and stroke/death (OR 1.80, 95% CI 1.55 to 2.10, p<0.001; I2=0%), whereas CCO patients who were treated with CAS were at an increased risk for death (OR 1.65, 95% CI 1.07 to 2.60, p=0.023; I2=0%) but not stroke (OR 0.94, 95% CI 0.61 to 1.47; p=0.080; I2=31%) or TIA (OR 1.18, 95% CI 0.18 to 7.55; p=0.861; I2=43%). The meta-regression analysis did not find any significant association for any of the outcomes, and there was no evidence of publication bias. Conclusion: Carotid revascularization outcomes are adversely affected by the presence of CCO. Patients with CCO have a significantly higher risk of periprocedural stroke, death, and TIA. CEA in patients with CCO is associated with an increased risk of perioperative stroke, death, TIA, and death/stroke, while CAS in the presence of a CCO is associated with an increased risk of periprocedural death but not stroke or TIA.

Development and validation of a predictive score for anterograde crossing of infrapopliteal chronic total occlusions: (The Infrapop-CTO Score).

BACKGROUND: Patients with critical limb ischemia often have infrapopliteal (IP) chronic total occlusions (CTOs). While revascularization is indicated to prevent major amputation, anterograde crossing of these lesions can be challenging, with high failure rates. OBJECTIVE: To develop and validate a scoring system that can adequately predict successful anterograde crossing of infrapopliteal CTOs. METHODS AND RESULTS: A total of 213 IP CTOs (147 successfully crossed with the anterograde approach vs. 66 where anterograde crossing failed) were included in the analysis. Backwards stepwise selection (p for retention <.05) was used to create a multivariable logistic regression model for the prediction of successful anterograde crossing using variables that were found to have a p < .1 in univariate analysis. The model was internally validated with bootstrapping and demonstrated excellent discriminatory ability (C-statistic 0.78 and Hosmer-Lemeshow p value = .61). A point score based on the beta-coefficient of the model variables was created, with one point assigned for presence of a noncentral (blunt) stump, one point for severe calcification at the entry site, and two points each for non-restenotic lesions or lesion length > 200 mm. The score was shown to have an excellent discriminatory ability for successful crossing, with low scores (0-2) associated with low failure rates (10%) and high scores associated with high failure rates (79%). CONCLUSIONS: The Infrapop-CTO score can stratify the procedural complexity of IP CTOs based on the likelihood of successful anterograde crossing. This score may help to direct optimal approaches toward infrapopliteal revascularization of patients with critical limb ischemia.

Acute and Midterm Outcomes of Antegrade vs Retrograde Crossing Strategies for Endovascular Treatment of Iliac Artery Chronic Total Occlusions.

PURPOSE: To examine whether an antegrade or retrograde crossing strategy for treatment of iliac artery chronic total occlusions (CTOs) is associated with differences in procedural or midterm outcomes. MATERIALS AND METHODS: A dual-center retrospective cohort study was conducted in 168 patients (mean age 66.4±10.6 years; 116 men) treated for CTOs in 110 common iliac arteries (CIA), 52 external iliac arteries (EIA), and 26 combined CIA/EIAs. Logistic regression models were developed to determine the association between crossing strategy and procedural complications, 1- and 3-year target lesion revascularization (TLR), and major adverse limb events (MALE). Results are presented as the odds ratio (OR) and 95% confidence interval (CI). RESULTS: An initial antegrade strategy was more common for EIA CTOs (p<0.005), and an initial retrograde strategy was more often used in CIA (p<0.005) and combined CIA/EIA (p<0.005) CTOs. Crossover to an alternate approach was required in 27.6% of initial antegrade attempts and 9.6% of initial retrograde attempts. EIA CTOs were the most likely lesions to be treated successfully with the initial attempt (either strategy). In all, 123 (65.4%) lesions were successfully crossed with a final retrograde approach and 65 with a final antegrade approach. Overall target lesion success was high for both groups (95.1% vs 93.2%, p=0.456). Lesions treated with a final retrograde approach were shorter (75.3±34.9 vs 87.6±31.3 mm, p=0.005) and were more likely to be treated with a reentry device (34.2% vs 9.2%, p<0.001) and with balloon-expandable stents (39.2% vs 17.7%, p=0.005). The final antegrade approach was associated with a lower risk of target lesion complications (OR 0.07, 95% CI 0.01 to 0.81, p=0.034). The two crossing approaches were associated with similar estimates of 1- and 3-year TLR and MALE. CONCLUSION: A final antegrade approach was associated with lower rates for complications but the 2 approaches were similar in terms of lesion success, TLR, and MALE. The EIA CTOs were more likely to be treated with an antegrade approach and more likely to be crossed successfully with the initial approach irrespective of the crossing direction.

Does minimalist transfemoral transcatheter aortic valve replacement produce better survival in patients with severe chronic obstructive pulmonary disease?

OBJECTIVES: To compare outcomes after minimalist and standard transfemoral transcatheter aortic valve replacement (TF-TAVR) in patients with severe chronic obstructive pulmonary disease (COPD). BACKGROUND: TF-TAVR is increasingly performed with conscious sedation and transthoracic echocardiography guidance (minimalist). The safety/efficacy of this technique in patients with severe COPD is unknown. METHODS: We compared demographics, 30-day outcomes and 1-year survival of patients with severe COPD (FEV1% ≤50) who underwent minimalist vs. standard TF-TAVR between 2008 and 2015 at our institution. RESULTS: Of 88 patients with severe COPD, 46 underwent minimalist and 42 underwent standard TF-TAVR. There were no differences on baseline characteristics, except for more history of coronary artery bypass grafting (45.5% vs. 20.6%, P = 0.03) and less history of cerebrovascular disease (16.7% vs. 45.5%, P = 0.03) in the standard TF-TAVR. Seventeen minimalist TF-TAVR patients (41.0%) were transferred directly to the general medical ward with telemetry monitoring (without ICU stay); all standard TF-TAVR patients went to the ICU. Minimalist TF-TAVR patients had shorter procedure time (97 vs. 129 min, P < 0.001), ICU time (21.8 vs. 29.8 hr, P = 0.001) and length of stay (2 vs. 5 days, P = 0.001). There were no differences in procedure complications and 30-day mortality between groups. In our multivariate analysis, minimalist TF-TAVR (HR 0.28, 95%CI 0.08-0.97) and previous coronary revascularization (HR 0.24, 95%CI 0.09-0.65) were associated with increased 1-year survival. In contrast, moderate paravalvular leak (HR 7.73, 95%CI 1.94-30.84) was associated with decreased 1-year survival. CONCLUSION: In patients with severe COPD, Minimalist TF-TAVR results in less resource utilization and improved 1-year survival compared to standard approach. Our findings should be validated in a larger cohort of patients with severe COPD. © 2016 Wiley Periodicals, Inc.