Posture commonly and considerably modifies stenosis of left common iliac and left renal veins in women diagnosed with pelvic venous disorder.

OBJECTIVE: Pelvic venous incompetence or pelvic congestion syndrome (commonly referred to as pelvic venous disorder [PVD]) is increasingly diagnosed, especially in multiparous women. This may be either primary or secondary to pelvic venous outflow obstruction-left common iliac vein (LCIV) or left renal vein (LRV) stenosis. Intravascular ultrasound (IVUS) examination performed in the supine position is commonly used for diagnosis of LRV and LCIV stenosis; however, body position may affect the cross-sectional area (CSA) of both of these veins during IVUS. The aim of the study was to test the hypothesis that postural changes may significantly affect the CSA of the LRV and LCIV. METHODS: A single-arm, single-center cohort study of women suffering from PVD was performed at a tertiary hospital in Poland. It comprised consecutive patients with either pelvic vein reflux or suggestion of LCIV or LRV obstruction but no signs of deep venous thrombosis. IVUS examination of the iliac veins, inferior vena cava, and LRV was performed in the supine position. IVUS of the LRV and LCIV was performed also with a Valsalva maneuver and with patients lying on the left side and standing. A 60% CSA reduction was used as a cutoff value between significant and nonsignificant vein stenosis. RESULTS: A total of 41 women were examined. Significant stenosis of the LRV was seen in 22 patients (55%) supine but in only 4 (10%) patients studied when lying on the left side and in 27 (67.5%) patients studied while standing. Significant stenosis of the LCIV was seen in 26 supine patients (63.4%), in 8 lying on the left side (19.5%), and in 10 (24.4%) standing. CONCLUSIONS: Postural changes dramatically affect CSA of the LCIV and LRV and thus the degree of stenosis in women diagnosed with PVD. Stenosis found in patients while supine often disappears when the position is changed to lying on the left side or to standing. Therapeutic decisions based on assessment of CSA reduction in the supine position are likely to be inadequate.

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.

PRELUDE Prospective Study of the Serranator Device in the Treatment of Atherosclerotic Lesions in the Superficial Femoral and Popliteal Arteries.

PURPOSE: To evaluate the safety and efficacy of the Serranator Alto PTA Serration Balloon Catheter in subjects with peripheral artery disease in the superficial femoral and popliteal arteries. MATERIALS AND METHODS: A prospective, multicenter, single-arm feasibility study enrolled 25 patients (mean age 66 years; 18 men) to evaluate Serranator inflation and postinflation effects under monitoring by independent core laboratories. Inclusion criteria were claudication or ischemic rest pain, de novo lesions or native artery restenosis, >70% stenosis, lesion length <10 cm, and a reference vessel diameter of 4 to 6 mm. Chronic total occlusions (CTO) up to 6 cm in length were allowed (n=8). The primary safety endpoint was 30-day major adverse events. Primary efficacy outcome was device success with final diameter stenosis <50%. The secondary objective was to confirm the presence of serrations across the lesions using optical coherence tomography (OCT) or intravascular ultrasound (IVUS) following treatment in a subset of 10 subjects. Follow-up evaluations were conducted at 30 days and 6 months. RESULTS: Technical success of device delivery and retrieval was 100%. The primary safety endpoint was met, with no patients experiencing a major adverse event in the first 30 days. Pretreatment stenosis of 88% was reduced to 23%. One stent was implanted for grade D dissection in a CTO. The core laboratory-adjudicated primary patency was 100% at 1 month and 64% at 6 months. Serrations were confirmed in all 10 OCT/IVUS images reviewed by the core laboratory. The Rutherford category showed significant and sustained improvement at 6 months. CONCLUSION: The Serranator is a safe and efficacious angioplasty balloon catheter system. This new design provides an exciting potential for optimizing vessel preparation and aiding drug delivery.

Involvement of CD8+ T cell subsets in early response to vascular injury in patients with peripheral artery disease in vivo.

AIMS: Adaptive immunity is critical in vascular remodelling following arterial injury. We hypothesized that acute changes in T cells at a percutaneous transluminal angioplasty (PTA) site could serve as an index of their potential interaction with the injured vascular wall. METHODS AND RESULTS: T cell subsets were characterised in 45 patients with Rutherford 3-4 peripheral artery disease (PAD) undergoing PTA. Direct angioplasty catheter blood sampling was performed before and immediately after the procedure. PTA was associated with an acute reduction of α/ß-TcR CD8+ T cells. Further characterisation revealed significant reduction in pro-atherosclerotic CD28nullCD57+ T cells, effector (CD45RA+CCR7-) and effector memory (CD45RA-CCR7-) cells, in addition to cells bearing activation (CD69, CD38) and tissue homing/adhesion markers (CD38, CCR5). CONCLUSIONS: The acute reduction observed here is likely due to the adhesion of cells to the injured vascular wall, suggesting that immunosenescent, activated effector CD8+ cells have a role in the early vascular injury immune response following PTA in PAD patients.

Myocardial injury after endovascular revascularization in critical limb ischemia predicts 1-year mortality: a prospective observational cohort study.

BACKGROUND: Patients with critical limb ischemia (CLI) are at increased risk of cardiovascular complications and mortality. To determine (1) incidence of myocardial injury following endovascular revascularization, and (2) relationship between myocardial injury with 1-year mortality and major adverse cardiovascular events (MACE; i.e., composite of myocardial infarction, stroke, and death). METHODS AND RESULTS: Single-center, prospective cohort study of CLI patients ≥ 45 years of age, who underwent endovascular revascularization with overnight hospitalization. High-sensitive troponins T (hsTnTs) were measured on admission, 3-6 h after endovascular revascularization and the subsequent morning. Myocardial injury after endovascular revascularization was defined as an hsTnT ≥ 14 ng/L with a relative increase ≥ 30% from the baseline value. We also evaluated other myocardial injury hsTnT thresholds (i.e., ≥ 30, ≥ 40, ≥ 60, and ≥ 80 ng/L). 239 consecutive patients (56% male, mean age 71.5 ± 10.1 years) were included; one patient was lost to follow-up. At 1 year, there were 34 deaths (14.2%), and 48 MACE (20.5%). Myocardial injury with the hsTnT threshold of 14 ng/L and relative increase by ≥ 30% from the baseline level occurred in 61 patients (25.5%). Myocardial injury was independently associated with 1-year mortality ([aHR], 2.44; 95% CI 1.18-5.06, for hsTnT ≥ 14 ng/L to aHR, 3.34; 95% CI 1.29-8.65 for hsTnT ≥ 80 ng/L). Myocardial injury was also independently associated with 1-year MACE ([AOR] 2.89; 95% CI 1.41-5.92 for hsTnT ≥ 14 ng/L to AOR, 6.69; 95% CI 2.17-20.68 for hsTnT ≥ 80 ng/L). 85.2% patients who had myocardial injury did not have ischemic clinical symptoms or electrocardiography changes. In sensitive analysis with exclusion of symptomatic patients that developed myocardial injury for the hsTnT ≥ 14 ng/L threshold, both the 1-year mortality (aHR: 2.19; CI 1.02-4.68; p = 0.04), and 1-year MACE (OR 2.25; CI 1.06-4.77; p = 0.036) remained significant. CONCLUSIONS: Myocardial injury is common following endovascular revascularization for CLI and associated with the risk of 1-year mortality and MACE.

Directional Atherectomy Followed by a Paclitaxel-Coated Balloon to Inhibit Restenosis and Maintain Vessel Patency: Twelve-Month Results of the DEFINITIVE AR Study.

BACKGROUND: Studies assessing drug-coated balloons (DCB) for the treatment of femoropopliteal artery disease are encouraging. However, challenging lesions, such as severely calcified, remain difficult to treat with DCB alone. Vessel preparation with directional atherectomy (DA) potentially improves outcomes of DCB. METHODS AND RESULTS: DEFINITIVE AR study (Directional Atherectomy Followed by a Paclitaxel-Coated Balloon to Inhibit Restenosis and Maintain Vessel Patency-A Pilot Study of Anti-Restenosis Treatment) was a multicenter randomized trial designed to estimate the effect of DA before DCB to facilitate the development of future end point-driven randomized studies. One hundred two patients with claudication or rest pain were randomly assigned 1:1 to DA+DCB (n=48) or DCB alone (n=54), and 19 additional patients with severely calcified lesions were treated with DA+DCB. Mean lesion length was 11.2±4.0 cm for DA+DCB and 9.7±4.1 cm for DCB (P=0.05). Predilation rate was 16.7% for DA+DCB versus 74.1% for DCB; postdilation rate was 6.3% for DA+DCB versus 33.3% for DCB. Technical success was superior for DA+DCB (89.6% versus 64.2%; P=0.004). Overall bail-out stenting rate was 3.7%, and rate of flow-limiting dissections was 19% for DCB and 2% for DA+DCB (P=0.01). One-year primary outcome of angiographic percent diameter stenosis was 33.6±17.7% for DA+DCB versus 36.4±17.6% for DCB (P=0.48), and clinically driven target lesion revascularization was 7.3% for DA+DCB and 8.0% for DCB (P=0.90). Duplex ultrasound patency was 84.6% for DA+DCB, 81.3% for DCB (P=0.78), and 68.8% for calcified lesions. Freedom from major adverse events at 1 year was 89.3% for DA+DCB and 90.0% for DCB (P=0.86). CONCLUSIONS: DA+DCB treatment was effective and safe, but the study was not powered to show significant differences between the 2 methods of revascularization in 1-year follow-up. An adequately powered randomized trial is warranted. CLINICAL TRIAL REGISTRATION: http://www.clinicaltrials.gov. Unique Identifier: NCT01366482.

Percutaneous Transluminal Angioplasty in Patients with Peripheral Arterial Disease Does Not Affect Circulating Monocyte Subpopulations.

Monocytes are mononuclear cells characterized by distinct morphology and expression of CD14 and CD16 surface receptors. Classical, quiescent monocytes are positive for CD14 (lipopolysaccharide receptor) but do not express Fc gamma receptor III (CD16). Intermediate monocytes coexpress CD16 and CD14. Nonclassical monocytes with low expression of CD14 represent mature macrophage-like monocytes. Monocyte behavior in peripheral arterial disease (PAD) and during vessel wall directed treatment is not well defined. This observation study aimed at monitoring of acute changes in monocyte subpopulations during percutaneous transluminal angioplasty (PTA) in PAD patients. Patients with Rutherford 3 and 4 PAD with no signs of inflammatory process underwent PTA of iliac, femoral, or popliteal segments. Flow cytometry for CD14, CD16, HLA-DR, CD11b, CD11c, and CD45RA antigens allowed characterization of monocyte subpopulations in blood sampled before and after PTA (direct angioplasty catheter sampling). Patients were clinically followed up for 12 months. All 61 enrolled patients completed 12-month follow-up. Target vessel failure occurred in 12 patients. While absolute counts of monocyte were significantly lower after PTA, only subtle monocyte activation after PTA (CD45RA and ß-integrins) occurred. None of the monocyte parameters correlated with long-term adverse clinical outcome. Changes in absolute monocyte counts and subtle changes towards an activation phenotype after PTA may reflect local cell adhesion phenomenon in patients with Rutherford 3 or 4 peripheral arterial disease.

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.

[Angina pectoris due to coronary-subclavian steal syndrome caused by the LIMA graft in the patient after CABG with the use of the right and left mammary artery]. / Dlawica piersiowa niestabilna spowodowana zespolem podkradania wiencowo-podobojczykowego przez LIMA z jednoczesnym krytycznym zwezeniem RIMA u pacjenta po CABG z uzyciem dwóch tetnic piersiowych wewnetrznych.

We present a case of a patient with unstable angina pectoris two years after coronary artery by-pass graft surgery with the use of the right and left mammary artery. The symptoms were caused by the critical RIMA stenosis and coronary-subclavian steal syndrome through the LIMA graft. Unsuccessful attempt of percutaneous angioplasty of the closed left subclavian artery was made. The angioplasty of the proximal part of the RIMA with the implantation of a drug eluting stent followed by the angioplasty of both left circumflex artery and obtuse marginal artery with the implantation of bare metal stents was performed. These procedures resulted in disappearance of anginal symptoms. Neurological examination did not reveal any signs of vertebrobasilar steal.

Express LD vascular stent in the treatment of iliac artery lesions: 24-month results from the MELODIE trial.

PURPOSE: To report the 2-year results of the MELODIE trial, which evaluated the safety and effectiveness of the balloon-expandable Express LD Vascular stent for the treatment of atherosclerotic iliac artery disease. METHODS: This prospective, multicenter, single-arm trial enrolled 151 patients (113 men; mean age 60.1±8.4 years) with 163 de novo or restenotic iliac lesions. The primary endpoint, 6-month angiographic mean percent loss of luminal diameter, was compared to an objective performance criterion (OPC) based on published results with the Palmaz stent. Follow-up included ankle-brachial index (ABI) measurement and symptom assessment (Fontaine classification) at discharge, 30 days, and 6, 12, and 24 months. Arteriography was performed at 6 months and computed tomographic angiography (CTA) at 1 and 2 years. RESULTS: The primary endpoint of 6-month mean percent luminal diameter loss was 16.2% (upper 95% confidence boundary of 19.1%) and non-inferior to the 20% OPC (p = 0.006). Primary patency was 92.1% at 6 months and 87.8% at 2 years. The rate of major adverse events (MAE) was 6.3% at 6 months and 10.2% at 2 years. Of the 3 event types included in the definition of MAE, only target lesion revascularization occurred; no distal embolization or device- or procedure-related deaths were recorded. The percent of patients with Fontaine stage IIb symptoms or worse improved from 84.1% before the procedure to 16.8% at 2 years (p<0.0001). The 2-year ABI remained significantly improved compared to baseline (0.85 versus 0.63, p<0.0001). CONCLUSION: The Express LD Vascular stent is safe, effective, and non-inferior to the Palmaz stent for treatment of iliac artery stenosis.

Reduced coronary flow reserve in Anderson-Fabry disease measured by transthoracic Doppler echocardiography.

Coronary flow reserve was assessed in a patient with Anderson-Fabry disease complicated by symmetric left ventricular hypertrophy. Coronary flow reserve was measurable in all three major coronary arteries providing an opportunity to compare regional coronary flow reserve from different vascular beds. In this patient all the three vascular beds supplied diffusely hypertrophied myocardium. Coronary flow disturbances in small intramyocardial perforating arteries were visible. The coronary flow reserve was reduced to a similar level (around to 2.0) in all three major arteries. In our patient with Anderson-Fabry disease, the coronary vasodilatation was blunted in a diffuse pattern corresponding to the myocardial hypertrophy distribution. In small intramyocardial arteries coronary flow was also disturbed. Accordingly, retrograde systolic flow and accelerated anterograde diastolic flow were documented.

[Interleukin-1beta C+3953T gene polymorphism and peripheral arterial occlusive disease in Polish population]. / Polimorfizm C+3953T genu dla interleukiny-1beta a choroba tetnic obwodowych w populacji polskiej.

The proinflammatory cytokines, like interleukine-1 (IL-1) and tumor necrosis factor-alpha (TNF-alpha), have been suggested to play a role in the development of atherosclerotic conditions, e.g. peripheral arterial occlusive disease (PAOD). Several genetic polymorphisms were described within the cluster of the IL-1 genes. The allelic variant C+3953T of the interleukin-1beta (IL-1beta) gene correlated with the cytokine level in vitro. The aim of this study was to estimate frequency of IL-1beta +3953 polymorphism in the Polish population and to test for its association with PAOD. We genotyped IL-1beta gene in 115 PAOD patients and 153 healthy controls. Genotypes distribution and allelic frequencies of C+3953T polymorphism did not differ between PAOD and controls. Thus, no association was observed between functional IL-1beta polymorphism and PAOD in our study. Frequency of the variant +3953T allele in Polish subjects (0.258) was similar to this found in other populations.

Transthoracic, harmonic mode, contrast enhanced color Doppler echocardiography in detection of restenosis after percutaneous coronary interventions. Prospective evaluation verified by coronary angiography.

AIMS: To test the feasibility and accuracy of transthoracic, harmonic mode, contrast enhanced Doppler echocardiographic assessment of lesion severity after PCI treatment in native coronary arteries--the LAD, Cx and RCA. METHODS AND RESULTS: Prospective evaluation of 59 patients (66 arteries). Restenosis was diagnosed whenever maximal flow velocity at least doubled in comparison to the segment immediately proximal to the PCI site or when local velocity was at least 2 m/s. At 9 months of follow-up final comparison of Doppler echocardiography and coronary angiography was performed with regard to 44 arteries in 40 patients. Of LAD segments assessed, 15 were proximal and 15 middle. The figures for Cx segments were: 4 proximal and 2 mid, and for RCA 2 proximal, 5 middle and 1 distal (i.e. the posterior descending coronary artery). On final coronary angiography there were 8 restenoses--all correctly diagnosed by echocardiography. There were 2 false-positive diagnoses of restenosis. Specificity for restenosis detection was 94% and sensitivity 100%. CONCLUSION: Transthoracic echocardiography allowed for accurate stenosis assessment of principal coronary arteries after successful PTCA. Feasibility of lesion site visualization was 100% for the LAD, 75% for the Cx and 43% for the RCA. Ultrasound contrast agent improved the quality of the RCA images.

[Myocardial infarction as an initial symptom of antiphospholipid syndrome, factor V Leiden mutation, and hyperhomocysteinemia]. / Zawal serca jako przejaw pierwotnego zespolu antyfosfolipidowego. Wspóludzial czynnika V Leiden i hiperhomocysteinemii.

We present a case of a 32-year-old male survivor of two myocardial infarctions, without any classic risk factor of atherosclerosis. Laboratory and genetic diagnostic tests revealed primary antiphospholipid syndrome, mutation in blood coagulation factor V (Leiden) and mild hyperhomocysteinemia, which could be predisposing factors for coronary artery occlusions and should especially be considered in a young patient without apparent cardiovascular risk factors. Additional anticoagulation and substitutional treatment of the folic acid, vitamin B6 and B12 are effective and the continues to do well at home 3 years after discharge.