Endothelial function in patients with critical and non-critical limb ischemia undergoing endovascular treatment.

BACKGROUND: Critical limb ischemia (CLI) is the most advanced stage of peripheral arterial disease. CLI patients, compared to non-CLI, achieve worse treatment outcomes and generate higher costs. AIMS: The aim of the study was to compare endothelial function and clinical outcomes in CLI and non-CLI patients after percutaneous transluminal angioplasty (PTA). METHODS: In this prospective, follow-up study, 30 CLI patients and 40 non-CLI patients underwent PTA. Endothelial function was assessed based on flow mediated dilatation (FMD), reactive-hyperemia index (RHI), while the ankle-brachial index, toe-brachial index and the Rutherford scale were used for peripheral artery disease progression evaluation. The results were assessed before PTA, as well as 1, 3, 6 and 12 months after the procedure. RESULTS: There were no differences at the baseline regarding to endothelial function between both groups. Neither FMD nor RHI changed after PTA in any of the groups, although there was a difference in median RHI value between CLI and non-CLI patients regarding the 1st and 6th month of the follow-up (RHI6-RHI1 = 0.08 in CLI and -0.15 in non-CLI; P = 0.01). The larger baseline intima-media thickness (IMT) in the CLI group allowed to predict a greater number of re-intervention (P = 0.01) and major adverse event rates (P = 0.03). CLI patients presented larger decrease in the Rutherford scale compared to non-CLI (P <0.001). CONCLUSIONS: Baseline IMT was predictive for re-interventions and major adverse event rates. Although neither of groups exhibited significant changes in endothelial function, we proved differences between them regarding to changes in RHI.

The relationship between pulse waveform analysis indices, endothelial function and clinical outcomes in patients with peripheral artery disease treated using percutaneous transluminal angioplasty during a one-year follow-up period.

BACKGROUND: Several predictors of clinical outcomes after percutaneous transluminal angioplasty (PTA) interventions in patients with peripheral arterial disease (PAD) have been investigated. Indices of endothelial function, arterial pulse waveform analysis (aPWA) and markers of peripheral artery ischemia were among the most commonly examined. The aim of the current study was to assess the relationship between potential predictors of clinical outcomes after peripheral artery PTA during a 1-year follow-up period. METHODS: The study included 72 individuals with PAD at a mean age of 66.3 ± 7.2 (79.1% males). All patients underwent PTA of the peripheral arteries. Among them, 42.8% presented critical limb ischemia (CLI). During the first visit and at 1 month and 6 months after PTA, endothelial function and aPWA measurements were taken. Ankle-brachial index (ABI), toe-brachial index (TBI) and physical evalu-ation of the limbs took place during the first visit and at 1, 6 and 12 months after the PTA. The study endpoints included myocardial infarction, amputation, death, stroke and reintervention. All subjects included in the study were observed for 386 days after the PTA. RESULTS: A significant improvement was noted in walking distance after PTA at the following time points, as well as transient improvement of ABI and flow-mediated dilatation (FMD) and no significant change in aPWA indices and reactive-hyperaemia index (RHI). The mean ABI, TBI, FMD and RHI values did not correlate with each other at baseline. There were 25 study endpoints which occurred in 16 patients during the follow-up period (22.2%). Patients with CLI, hypercholesterolemia, lower dias-tolic blood pressure, higher subendocardial viability ratio, a greater number of pack-years and lower TBI at baseline presented significantly poorer clinical outcomes in terms of endpoint events. CONCLUSIONS: Endothelial function assessed as FMD and reactive hyperemia-peripheral arterial tonometry (RH-PAT) before PTA in patients with advanced PAD do not predict clinical outcomes during the 1-year follow-up.

Clinical and linguistic validation of the Polish version of VascuQol: a disease-specific quality-of-life questionnaire assessing patients with chronic limb ischemia

INTRODUCTION Objective clinical assessments should include patient­reported outcome measures. VascuQol is an established disease­specific questionnaire assessing the quality of life in patients with peripheral artery disease (PAD). Quality­of­life questionnaires require geographical localization and validation. OBJECTIVES The goal of this study was to validate the Polish version of the VascuQol: a patient­reported health­related quality­of­life (HRQoL) instrument specific for PAD. PATIENTS AND METHODS The linguistic validation of VascuQol followed Mapi Institute methodology. Clinical validation process compared VascuQol, EQ­5D­3L, and SF­36 questionnaires in 100 patients with both intermittent claudication and critical limb­threatening ischemia. Cronbach α coefficients for reliability, receiver operating characteristic curves for clinical discriminative performance, standardized response means for responsiveness, and Pearson correlations for construct validity were evaluated. Additionally, in a separate cohort of 58 patients with stable disease, the test­retest was characterized with intraclass correlation, Bland­Altman analysis, and Pearson correlation coefficients. RESULTS VascuQol proved to perform better than SF­36 and EQ­5D­3L. Cronbach α coefficients showed good internal consistency (α values >0.9 for all summary scores). All test­retest Pearson r values for VascuQol were above 0.70. The intraclass correlation of absolute agreement consistency exceeded 0.8. The Bland­Altman 95% limits of agreement were between 2.72 and 4.87. There were strong and moderate correlations for total scores in all domains between VascuQol and SF­36, and for most of the domains between VascuQol and EQ­5D­3L. CONCLUSIONS The Polish version of VascuQol is a sensitive, accurate, and reliable tool for assessing HRQoL in patients with PAD.

Dynamics of below-the-knee arterial blood flow after endovascular revascularisation of peripheral arteries as a potential predictor of clinical outcomes during one-year follow-up.

BACKGROUND: Patients with advanced lower limb ischaemia are, at present, mainly treated using revascularisation. AIM: The aim of the study was to investigate whether the dynamics of blood flow in below-the-knee (BTK) arteries assessed by angiography correlate with clinical outcomes after a 12-month follow-up in patients with severe leg ischaemia treated per-cutaneously. METHODS: The current study enrolled 287 consecutive patients who underwent 302 endovascular procedures on the infrain-guinal arteries. The mean age of the included participants was 67.4 ± 10.4 years. After the procedure, blood flow in all patent BTK arteries was assessed using frame count (FC). Patients were then evaluated after one, three, six, and 12 months. During the follow-up visits, clinical condition was evaluated based on the Rutherford scale, ankle-brachial index, and the need for reintervention or amputation. RESULTS: Clinical improvement at the end of the follow-up period was observed in 242 (80.1%) cases and no improvement or worsening in was seen in 42 (13.0%) patients. In total, 66 (21.8%) reinterventions and 18 (6%) amputations during the follow-up period were recorded. Patients with higher FC in the tibial anterior artery experienced significantly better clinical improvement within the 12-month follow-up period (p = 0.02). Lower FC predisposed to worse clinical outcomes after an-gioplasty. Similar tendencies were found for the tibial posterior and fibular arteries but without statistical significance. CONCLUSIONS: The results suggest a negative relationship between FC observed on the final angiogram and clinical outcomes in patients undergoing endovascular treatment of the peripheral arteries.

Costs of Real-Life Endovascular Treatment of Critical Limb Ischemia: Report from Poland-A European Union Country with a Low-Budget Health Care System.

BACKGROUND: To analyze the costs of inhospital, percutaneous treatment of patients with critical limb ischemia (CLI) carried out in Poland, a European Union country with a low-budget national health system. METHODS: A retrospective analysis of prospectively collected data on all patients admitted to a tertiary care hospital for endovascular treatment of CLI over 1 year. SETTING: A single, large volume, tertiary angiology center located in Southern Poland. PARTICIPANTS: CLI patients due to aortoiliac, femoropopliteal, or infrapopliteal arterial stenoses or occlusions with indications for first-line endovascular therapy or similar patients who refused open surgical procedure despite having primary indications for vascular surgery. INTERVENTIONS: Direct stenting using bare-metal stents was the primary mode of treatment for lesions located within the aortoiliac and femoropopliteal arterial segments. Plain old balloon angioplasty (POBA) was the second most commonly used technique. For below-the-knee arteries, POBA was the mainstay of treatment, which was occasionally supported by drug-eluting stent angioplasty. Directional atherectomy, scoring balloon angioplasty, or local fibrinolysis was used infrequently. Drug-eluting balloon percutaneous transluminal angioplasty was not used. MAIN OUTCOME MEASURES: The main outcome measures were the mean reimbursement of costs provided by the Polish National Health Fund (NHF) for inhospital treatment of patients for whom endovascular procedures were performed as initial treatment for CLI and the inhospital costs of endovascular treatment calculated by the caregiver in the 2 years since the first procedure. The average total number of days spent in hospital, amputation-free survival (AFS), overall survival (OS), and limb salvage rate (LSR) according to a life-table method were also calculated for the 2 years. RESULTS: In the first year, there were 496 endovascular and 15 surgical hospitalizations for revascularization procedures to treat 340 limbs in 327 patients, with a further 53 revascularization procedures in the second year. There were an additional 90 hospitalizations over the first year and 38 over the second year for CLI-associated cardiovascular comorbidities. The mean reimbursement for hospitalizations of patients included into observation, provided by the NHF, was $4901.94 per patient for the first year and $833.57 per patient alive to the second year. The mean cost of hospitalization for percutaneous revascularization treatment was $3804.25 per patient for the first year and $3340.30 per patient requiring revascularization within the second year. All costs were calculated in constant 2011 USD. The average total number of days spent in hospital was 8.4 days for the first year and 1.97 days per patient alive to the second year. At 1 and 2 years, the AFS was 76.8% and 66.6%, the OS was 86.5% and 77.3%, and the LSR was 89.4% and 86%, respectively. CONCLUSIONS: Endovascular therapy using the currently available techniques can be performed in almost all patients suffering from CLI at relatively low costs, and satisfactory results can be obtained. Physicians play a pivotal role in ensuring quality of treatment and the reduction of treatment cost in these patients.