Investigation of Acoustic Properties of Different Types of Low-Noise Road Surfacers under In Situ and Laboratory Conditions.

Current literature on the performance characteristics of road surfaces is primarily focused on evenness, roughness and technical durability. However, other important surface properties require analysis, including noisiness, which is an important feature of the environmental impact of vehicular traffic around roads. This can be studied using various methods by which road noise phenomena are investigated. The method used to measure the noise performance of road surfaces herein is the Statistical Pass-By (SPB) method, as described in ISO 11819-1:1997. The impedance tube method was used for sound absorption testing, as described in ISO 13472-2:2010. These tests were performed under a variety of conditions: in situ and in laboratory. The existence of relationships between them can be helpful in selecting surfaces for noise reduction. Preliminary surface noise tests can be performed in the laboratory with samples consisting of various compounds. This is less expensive and faster than doing so on purpose-built surfaces. The paper presents study results for sound absorption coefficients of various types of low-noise surfaces in in situ conditions (on an experimental section and on operated road sections) and in the laboratory setting. The results of the tests performed on the operational sections were compared to the results of the surface impact on road noise using the SPB method. The correlations between the test results help confirm the feasibility of road surface pre-testing in the laboratory and the relation to tests performed using the SPB method under typical operating conditions.

The Polish Interventional Cardiology TAVI Survey (PICTS): 10 years of transcatheter aortic valve implantation in Poland. The landscape after the first stage of the Valve for Life Initiative.

INTRODUCTION: Few studies assessed the development of transcatheter aortic valve implantation (TAVI) in Poland since its introduction in 2008. Effects of the Valve for Life Initiative in the country have not been reported. OBJECTIVE: The aim of the study was to investigate TAVI adoption and practice in Poland in the years 2008 to 2019. PATIENTS AND METHODS: The Polish Interventional Cardiology TAVI Survey (PICTS) analyzed reports of TAVI activity in all 23 TAVI centers. It consisted of 94 questions and encompassed the following topics: 1) characteristics of centers; 2) the annual number of TAVI procedures in the years 2008 to 2019; 3) pre-, intra-, and postprocedural management of patients; and 4) a list of TAVI team members. It was obligatory to answer all questions. The registry survey was published online. RESULTS: Since 2008, 102 certified operators have performed a total of 6910 procedures. In 2019, the annual number of TAVI reached 1550 (40.38 implants per 1 000 000 inhabitants). Among patients aged 65 years and older, TAVI penetration rate was 18.65% in 2019. Inoperable and high-risk patients were treated in all centers, while 18 also treated medium- and 5 treated low-risk individuals. The rate of transfemoral implantations increased to 93.5% of all procedures. CONCLUSIONS: The survey highlighted a slow increase in the rate of TAVI adoption in Poland. We found a significant treatment gap in patients with severe aortic stenosis. Remarkable regional variations in TAVI experience exist among Polish TAVI centers. Further multinational cooperation is warranted to tackle the identified limitations in access to this life-saving procedure.

Long­term outcomes of transcatheter self-expanding aortic valve implantations in inoperable and high surgical-risk patients with severe aortic stenosis: a single-center single-valve registry.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) is being increasingly used in patients with longer life expectancy. Data on long­term outcomes are still limited. AIMS: The aim of the study was to assess the clinical outcomes of patients treated with TAVI and identify baseline and procedure­related factors influencing long­term survival. METHODS: Symptomatic patients with critical aortic stenosis who were inoperable or had high surgical risk were qualified for TAVI. Between August 2012 and December 2017, 248 consecutive patients treated with self ­expanding Medtronic valve implantation at American Heart of Poland in Bielsko­Biala were prospectively enrolled. Patients were followed for 30 days after the procedure and subsequently annually. All events were classified according to the Valve Academic Research Consortium­2 (VARC­2) criteria and assessed. Survival was compared between the subgroups defined by the EuroSCORE II (European System for Cardiac Operative Risk Evaluation II) and with matched representatives from the general population. RESULTS: The median (interquartile range) follow­up was 3.4 (2.5-4.6) years, and the longest follow­up lasted 7.8 years. A total of 92 patients (37.1%) died during the follow­up. The Kaplan-Meier estimates for cumulative mortality at 1, 3, 5, and 7 years were: 11.3%, 26.8%, 42.1%, and 60.6%. Patients with EuroSCORE II greater than 6% experienced worse survival compared with those with EuroSCORE II 6% or less (P = 0.008). Patients with EuroSCORE II 6% or less had similar survival to the general population. Male sex, baseline eGFR of less than 50 ml/min/1.73 m2, chronic obstructive pulmonary disease, moderate / severe paravalvular leak, absence of postdilatation, major vascular complication, and stroke at 30 days were independently associated with long­term mortality. CONCLUSIONS: TAVI with a self­expanding Medtronic valve implantation according to a consistent protocol was associated with favorable outcomes. Patients with lower EuroSCORE II scores had the same prognosis as the actuarial survival of the general population.

Aborted myocardial infarction in patients with ST-segment elevation myocardial infarction treated with mechanical reperfusion.

BACKGROUND: Aborted myocardial infarction (abMI) is a type of acute coronary syndrome in which patients treated with reperfusion avoid the great burden of necrosis. Yet, no definition of abMI in patients undergoing primary percutaneous coronary intervention (pPCI) has been proposed so far. AIMS: This study aimed to identify patients with abMI and compare them with the remaining patients with ST­segment elevation myocardial infarction (STEMI). METHODS: It was a retrospective study of 1693 consecutive patients with STEMI treated with pPCI. The median (IQR) follow­up was 3.45 (1.45-5.09) years. Aborted MI was diagnosed if ST­segment elevation was reduced by more than 50%, no new abnormal Q waves were observed, the maximal level of creatine kinase MB did not reach a value 5­fold higher than the upper limit of normal (below 125 U/l), and there was successful reperfusion defined as the Thrombolysis in Myocardial Infarction score of 3 after PCI. RESULTS: Using our definition, abMI was diagnosed in 176 cases (10.4%). Compared with the remaining patients with STEMI, those with abMI were younger (mean [SD] age, 61.8 [11.5] vs 64.4 [11.6] years; P = 0.005) and were more frequent smokers (48.9% vs 36.7%; P = 0.002). They had greater left ventricular ejection fraction (median [interquartile range (IQR)], 49% [40%-55%] vs 55% [51%-60.5%]; P <0.001), were discharged earlier from the hospital (hospitalization time, median [IQR], 73 [60-90.5] hours vs 87 [69-98] hours; P <0.001), and had a lower mortality rate at 1 month and long­term follow­up (2.27% vs 8%; P = 0.006 and 10.8% vs 23.9%; P <0.001, respectively). CONCLUSION: Patients with abMI had better short­ and long­term outcomes than other patients with STEMI. Some negative cardiovascular factors such as smoking were more often observed in the abMI group.

Influence of the Acoustic Cover of the Modular Expansion Joint on the Acoustic Climate in the Bridge Structure Surroundings.

The noise generated at the interface between the wheels of vehicles and the road surface is well recognized in the literature worldwide. Many publications describe the phenomenon of reducing this kind of impact by silent road surfaces. A specific type of this noise is the sound generated by vehicles passing over the expansion joints of bridge structures. Due to the impulsive nature of this sound, it is very onerous for people living in the close vicinity of bridge structures. The passage of vehicles over expansion joints causes the formation of vibrations that are transmitted to the structural elements of bridge structures, which may cause the formation of the material sounds (especially arduous in the case of bridges with steel elements). An attempt to reduce this impact was made by making a prototype acoustic cover of the expansion joint on the selected bridge. The paper presents the results of research on the "in situ" acoustic effectiveness of this cover. Additionally, the noise was modelled in the object surroundings before and after the cover's application. The acoustic efficiency of the cover in the whole measured frequency range was 5.3 dBA. In the narrower frequency bands (1/3 octave bands), larger sound level reductions were observed. The maximum sound levels measured under the tested dilatation were less than 10.0 dBA lower than the maximum sound levels measured under the reference dilatation.

Early results of the ongoing Polish Registry of Valve Thrombosis after Transcatheter Aortic Valve Implantation (ZAK­POLTAVI).

BACKGROUND: Conflicting data exist regarding the risk factors for transcatheter heart valve thrombosis (THVT). In addition, no optimal pharmacological strategy to treat THVT has been established so far Aims: The aim of this study was to assess the incidence, risk factors, diagnostic workup, and treatment of THVT in Poland. METHODS: Data were collected retrospectively in themulticenter registry of patients with THVT (ZAK­POLTAVI) between November 2008 and November 2018. Transcatheter heart valve thrombosis was defined as an increased mean transvalvular gradient accompanied by a decreased effective orifice area or severe aortic regurgitation, reversible after treatment. Baseline characteristics and procedural data were compared between patients with THVT and those without THVT (matched by age, sex, and diabetic status). RESULTS: In a group of 2307 patients undergoing transcatheter aortic valve implantation (TAVI), 26 patients with THVT were identified (incidence, 1.14%). In half of the patients, THVT was diagnosed within 6 months after TAVI. As compared with the control group, patients with THVT more frequently had chronic obstructive pulmonary disease (P = 0.035), a smaller aortic valve area (P = 0.007), a higher mean postprocedural transvalvular gradient (P = 0.037), and a lower platelet count (P = 0.029) at the time of the diagnosis. A total of 24 patients (84.6%) received anticoagulation therapy for THVT, and complete resolution of THVT was noted in 12 individuals (46.1%). We observed thromboembolic complications in 2 patients (7.7%). CONCLUSIONS: Transcatheter heart valve thrombosis is a rare complication of TAVI. However, a higher risk of THVT may be expected in patients with chronic obstructive pulmonary disease, a smaller aortic valve area, a higher mean postprocedural transvalvular gradient, and a lower platelet count. Anticoagulation alone or combined with antiplatelet therapy seems to be the optimal pharmacological treatment in this population.

Utilisation of bivalirudin and vascular closure devices for same-day discharge after percutaneous coronary and peripheral interventions.

BACKGROUND: Currently the majority of coronary and peripheral interventions are performed with an overnight stay. This increases the cost and does not reduce logistic constraints on hospital resources. We hypothesised that by combining bivalirudin with vascular closure devices we can safely discharge patients on the same day after percutaneous coronary intervention (PCI) and percutaneous transluminal angioplasty (PTA) without increasing their risk of bleeding. AIM: To evaluate the safety and the feasibility of same-day discharge after PCI and PTA using bivalirudin and vascular closure devices. METHODS: This is a retrospective analysis of 833 consecutive patients who underwent percutaneous procedures in our centre between January 2007 and February 2010. The population was divided into interventional and diagnostic arms. All interventions were done with use of bivalirudin for anticoagulation and vascular closure devices for achieving haemostasis. Haemostasis in the diagnostic cohort was achieved with standard manual compression. The mean time of observation was 30 days. The mean age of patients was 64.3 years. The primary endpoint was any bleeding event meeting GUSTO criteria. The secondary endpoints included local vascular complications, major adverse cardiac and cerebrovascular events, time to ambulation and discharge, as well as need for overnight hospitalisation. RESULTS: In 30-day observation the primary endpoint occurred in 4.0% of patients in the interventional group and in 2.6% of patients in the diagnostic group (p = 0.31). The frequency of local vascular complications was higher in the interventional group although it was not statistically significant (3.1% vs. 2.9%; p = 0.33). Patients from the interventional group were ambulated sooner compared to the diagnostic group (117.5 vs. 131 min; p = 0.003). Time to discharge was 316.4 ± 38.7 min and 214.2 ± 23.4 min for interventional and diagnostic procedures, respectively (p < 0.001). CONCLUSIONS: PCI and PTA in the selected group of patients, with use of bivalirudin and vascular closure devices, do not appear to have increased risk of post-procedural events when compared to diagnostic procedures, and can be done safely without the need for an overnight stay.

[Heart failure due to chronic hypoparathyroidism in patient with acute coronary syndrome]. / Zaawansowana niewydolnosc serca w przebiegu przewleklej niedoczynnosci przytarczyc u chorego z ostrym zespolem wiencowym.

Severe heart failure can be a rare symptom of hypocalcemia. We report a case of a 58 year-old male admitted with a diagnosis of acute coronary syndrome. The ECG showed prolonged QTc interval with severly impared left ventricular ejection fraction recognised in echocardiography. During the hospitalisation hypocalcemia due to primary hypoparathyreoidism was revealed to be the cause of those symptoms.

[Acute myocardial infarction with simultaneous occlusions of two coronary arteries in a 44 year-old man]. / Zawal serca u 44-letniego chorego spowodowany jednoczesnym zamknieciem dwóch tetnic wiencowych.

Simultaneous thrombosis of multiple epicardial coronary arteries is an uncommon clinical finding in ST-segment elevation myocardial infarction (STEMI). We describe a 44 year-old male present with STEMI who was found to have simultaneously occluded two epicardial arteries. There is many clinical states that can lead to multiple thrombosis i.e. essential trombocytosis, hiperhomocysteinaemia, depletion of antitrombin III, cocaine abuse etc. In this particular case L-arginin supplementation and association with thrombosis or atherosclerosis progression is discussed.

Long-term results of cephalad arteries percutanoeus transluminal angioplasty with stent implantation (The CAPTAS registry).

INTRODUCTION: Carotid artery stenting (CAS) has become an alternative to carotid endarterectomy. Moreover, percutaneous transluminal angioplasty (PTA) allows other cephalad arteries revascularization. The aim of this study was to evaluate late outcomes of cephalad arteries PTA. METHODS: This is an international multicenter registry of 434 consecutive patients in which 497 PTAs were performed. Patients with symptomatic >50% stenosis or asymptomatic >70% stenosis were enrolled. Stenting of 577 internal carotid arteries (ICA) and 13 common carotid arteries was performed, 20.7% procedures were complex in which bilateral carotid stenoses or carotid and vertebral arteries stenoses were revascularized at one stage. In 15.9% patients, one-stage coronary intervention was carried out. Distal protection devices were used in 69.6% of cases. PTAs were divided into high (n = 330) and low (n = 167) risk of major adverse coronary and cerebral events (MACCE). RESULTS: At 30 days, there were 15 (3.5%) cases of MACCE [0.9% deaths, 2.1% strokes, and 0.9% myocardial infarction (MI)]. TIAs were observed in 15 (3.9%) patients. There was no significant difference in stroke incidence between procedures with or without neuroprotection (1.8 vs. 3%; P = 0.66) as well as in MACCE occurrence between high and low-risk groups (4.3 vs. 2%; P = 0.34). Bilateral stenoses increased while hypertension decreased the risk of MACCE. Left ICA lesions increased the risk of cerebrovascular accidents (CVA). At 4 years (1-11 years), the mortality rate was 11.5%, 6% of patients had stroke, and 3% MIs. Restenosis occurred in 3%. There was a trend toward higher mortality rate (13.3 vs. 6.9%; P = 0.07) and MACCE risk in high-risk group (23.5 vs.14.7% P = 0.06). Age > 65 y.o. and stent length < 24 mm increased, while the statin therapy on admission decreased the risk of long-term death. Structural valve disease and stent length <30 mm increased the risk of MACCE, while implantation of Acculink stent decreased the risk of CVA. CONCLUSIONS: CAS is safe and successful procedure with low early and long-term adverse events. Special attention should be put on patients with bilateral and left ICA stenoses. If possible, longer stents should be applied.

Controlled reperfusion with intravenous bivalirudin and intracoronary abciximab combination therapy in the porcine myocardial infarction model.

INTRODUCTION: The reperfusion injury (RI) remains a significant limitation of primary PCI, therefore we evaluated the role of intracoronary abciximab and bivalirudin for anticoagulation on myocardial salvage and RI in the porcine model of ischemia/reperfusion. MATERIALS AND METHODS: Myocardial infarction was induced in 23 pigs by 60-minute over-the-wire (OTW) balloon occlusion of the LAD. Animals received intravenous bivalirudin and then five minutes prior to reperfusion, either a coronary downstream infusion of abciximab (n=11) or saline (n=12) through the central lumen of an OTW catheter. All animals were followed for 48 hours. RESULTS: Histological analysis showed that infarct area (IA) and area at risk (AAR) were comparable between groups (IA/AAR%: 57.6 ± 8% vs. 57.1 ± 7%, p=0.8). Confirming this trend, biochemical markers (troponin I, TNF-alpha, IL-6, hsCRP, adiponectin, and VCAM) and left ventricular ejection fraction were also similar at 48 hours. Adhesion markers like ICAM and P-selectin were significantly decreased in the study group, nevertheless histological evidence of leukocyte extravasation was similar. The enhancement of apoptosis by TUNEL was comparable in both groups. The number of hemorrhagic infarctions confirmed by micro and macroscopic evaluation tended to be higher in the study group (70% vs. 20%, p=0.07). CONCLUSIONS: Despite lowered concentrations of adhesion molecules, intracoronary abciximab with peripheral bivalirudin is not superior to bivalirudin unaided in terms of myocardial salvage caused by RI in the porcine ischemia/reperfusion model. This might be due to local hemorrhage caused by abciximab.

Intracoronary adiponectin at reperfusion reduces infarct size in a porcine myocardial infarction model.

Reperfusion injury (RI) remains an important limitation of myocardial revascularization. The aim of the present study was to evaluate the influence of the intracoronary injection of adiponectin on RI and cardiomyocyte death in a porcine myocardial infarction model. Acute infarction in 14 Polish domestic pigs was induced by inflation of an over the wire balloon (OTW) catheter in the medial left anterior descending artery for 60 min. The study group consisted of 7 pigs in which intracoronary adiponectin (50 µg) was infused through the OTW catheter immediately before reperfusion. The control group (n=7) was administered placebo. Animals were sacrificed after two days of follow-up. The infarct area (IA) was stained with tetrazoline and the area at risk (AAR) with intracoronary administration of Evans Blue dye before euthanasia. Hearts in each group had similar AARs (46.2±9.9% vs. 48.4±6.2% of the whole myocardium, p=ns). The IA/AAR% and IA were smaller in the study group when compared to the control (24.7±4.0% vs. 45.3±22.5%, p=0.005; and 11.7±4.9% vs. 20.5±5.6%, p=0.01, respectively). These outcomes corresponded well with the peak troponin levels after 12 h (109.9±60.9 ng/ml vs. 185.5±39.4 ng/ml, p=0.017). After two days there was a significantly higher LVEF in the study group (51.4±8.5% vs. 33.9±8.6%, p=0.002). There was also a trend toward lower apoptosis enhancement in the viable myocardium in the study group (3.11±2.3 vs. 8.92±6.3; p=0.07). The administration of adiponectin into the infarct- related artery is safe and feasible. The treatment significantly reduced the infarct size.

Effects of local intracoronary paclitaxel delivery using the Remedy transport catheter on neointimal hyperplasia after stent implantation in a porcine model.

PURPOSE: To assess the effects of local paclitaxel delivery using the Remedy catheter on neointimal hyperplasia in a porcine model and compare these results to commercially available BMS and biodegradable polymer-coated paclitaxel-eluting stents (BP-PES). METHODS AND MATERIALS: A total of 31 stents were implanted into coronary arteries of 15 domestic swine including eight BMS, six BP-PES, and 17 BMS after intravasal paclitaxel delivery at doses of 250 µg (LPD250; n=9) and 500 µg (LPD500, n=6). All stents were implanted under quantitative coronary angiography (QCA) guidance to achieve a balloon/artery diameter ratio of 1.15:1.0. Twenty-eight days after the procedure, follow-up coronary angiography was performed, the animals were euthanized, and the coronary arteries harvested for histopathological analysis. RESULTS: At follow-up, QCA analysis revealed that lumen loss was significantly worse in BMS and in both LPD groups in comparison to BP-PES stents (P=.02). Histomorphometric analysis showed that the LPD500 group presented the highest percentage of area stenosis, achieving a statistically significant difference in comparison to BMS and BP-PES stents. CONCLUSION: Our study demonstrates that local paclitaxel delivery using the Remedy transport catheter in the two studied doses (250 and 500 µg) is not effective at neointimal hyperplasia inhibition.

Comparison of thin-strut cobalt-chromium stents and stainless steel stents in a porcine model of neointimal hyperplasia.

BACKGROUND: The high radial force and durability of cobalt-chromium alloy enable the construction of low-profile stents with thin struts, which improves their elasticity and may play a key role in reducing the incidence of neointimal hyperplasia as well as allow faster endothelialization. The aim of this study was to compare cobalt-chromium (CoCr) and stainless steel (SS) coronary stents in a pig model of neointimal hyperplasia. MATERIAL/METHODS: Eighteen stents were implanted into the coronary arteries of nine pigs. Control coronarography was performed 28 days after stent implantation. The animals were then sacrificed, their hearts explanted, and the coronary arteries isolated for further histopathological analysis. RESULTS: Quantitative coronary angiography and histomorphometric analysis revealed no statistically significant difference between the two groups of stents. However, there was a trend toward greater late lumen loss (p=0.09) and neointimal area in the CoCr stents (p=0.08). The qualitative histopathology of the CoCr stents revealed findings typical of bare metal stents reviewed in the literature and approved for use in clinical practice. No signs of stent thrombosis, necrosis, or fibrin deposits were observed nor signs of excessive inflammatory reaction. Endothelialization was complete within 28 days. CONCLUSIONS: Despite thinner struts, CoCr stents have no advantage over stainless steel stents in terms of neointimal hyperplasia inhibition. However, their positive safety results together with their high radial strength, low profile, and excellent elasticity can ensure their usage, especially in lesions of complex morphology.

Early and long-term results of unprotected left main coronary artery stenting: the LE MANS (Left Main Coronary Artery Stenting) registry.

OBJECTIVES: The aim of the study was to evaluate early and late outcomes after percutaneous coronary intervention (PCI) of unprotected left main coronary artery disease (ULMCA) and to compare bare-metal stent (BMS) and drug-eluting stent (DES) subgroups. BACKGROUND: PCI is an increasingly utilized method of revascularization in patients with ULMCA. METHODS: This multicenter prospective registry included 252 patients after ULMCA stenting enrolled between March 1997 and February 2008. Non-ST-segment elevation acute coronary syndrome was diagnosed in 58% of patients; ST-segment elevation myocardial infarction cases were excluded. Drug-eluting stents were implanted in 36.2% of patients. RESULTS: Major adverse cardiovascular and cerebral events (MACCE) occurred in 12 (4.8%) patients during the 30-day period, which included 4 (1.5%) deaths. After 12 months there were 17 (12.1%) angiographically confirmed cases of restenosis. During long-term follow-up (1 to 11 years, mean 3.8 years) there were 64 (25.4%) MACCE and 35 (13.9%) deaths. The 5- and 10-year survival rates were 78.1% and 68.9%, respectively. Despite differences in demographical and clinical data in favor of BMS patients, unmatched analysis showed a significantly lower MACCE rate in DES patients (25.9% vs. 14.9%, p = 0.039). This difference was strengthened after propensity score matching. The DES lowered both mortality and MACCE for distal ULMCA lesions when compared with BMS. Ejection fraction <50% was the only independent risk factor influencing long-term survival. CONCLUSIONS: Stenting of ULMCA is feasible and offers good long-term outcome. Implantation of DES for ULMCA decreased the risk of long-term MACCE, and particularly improved survival in patients with distal ULMCA disease.

[Primary percutaneous coronary intervention complicated by left anterior descending artery perforation - a case report]. / Pierwotna przezskórna angioplastyka wiencowa powiklana perforacja tetnicy przedniej zstepujacej - opis przypadku.

A case of a 72-year-old man with anterior wall myocardial infarction and PCI procedure complicated by coronary artery perforation, is presented. Life-threatening complication was successfully treated percutaneously with graft-stent implantation, and the patient was discharged home five days later in a good condition. Control coronary angiography after 3 months was scheduled.

Drug delivery at the aortic valve tissues of healthy domestic pigs with a Paclitaxel-eluting valvuloplasty balloon.

BACKGROUND: Restenosis occurs invariably within 1 year following balloon valvulopasty in aortic valve stenosis. The mechanism of restenosis seems to involve a dynamic cellular component that could be a target for drug inhibition. We investigated the feasibility of local drug delivery at the aortic valve tissues of healthy pigs with a paclitaxel-eluting balloon. METHODS: Aortic valvuloplasty was performed in eight anesthetized domestic pigs using paclitaxel-eluting balloons (3 micro2) balloon surface area). They were assigned to two or four times 15-second balloon inflations and were sacrificed 30 minutes after final balloon inflation. RESULTS: The aortic annulus to balloon diameter ratio was 1.15 +/- 0.07. The mean paclitaxel concentration in the aortic valve leaflets was 0.91 +/- 1.36 micro (0.34 +/- 0.05 micro in the two-inflation group, 1.48 +/- 1.86 micro in the four-inflation group, P = 0.23). The percentage of the total paclitaxel dose recovered in the aortic valve leaflets was 18 +/- 11(-6)% (13 +/- 6(-6)% and 25 +/- 14(-6)% in the two- and four-inflation group, P = 0.16). CONCLUSION: Local drug delivery at the aortic valve leaflets of healthy pigs with a paclitaxel-eluting balloon is feasible and concentrations within the therapeutic window are detected 30 minutes after the procedure. The antirestenotic potential of this treatment should be studied.

Early and late outcomes of percutaneous transluminal angioplasty of cephalad arteries.

BACKGROUND: Efficacy of carotid endarterectomy (CEA) in prevention of stroke in patients with carotid artery stenosis has been confirmed in randomised trials. Carotid artery stenting (CAS) is a routine clinical practice and recent results of CAS are not worse than CEA. Moreover, percutaneous transluminal angioplasty (PTA) techniques allow other cephalad arteries to be dilated. AIM: To assess early and long-term outcome of PTA of cephalad arteries and to determine risk factors of early and late major adverse cardiovascular and cerebral events (MACCE). METHODS: The study group consisted of 223 consecutive patients (151 males, 67.7%, mean age 65.3+/-8.6) in whom 256 PTA procedures of cephalad arteries were performed. Two hundred and forty-two internal carotid, 7 common carotid and 15 vertebral arteries were dilated. Thirty-four patients underwent one-stage carotid and coronary procedures, while in 46 patients one-stage carotid and peripheral procedures were performed. Neuroprotection with a distal protection device was used in 51.5% of cases. The procedures were divided into two groups: with high (n=181) and low (n=75) risk of cardiovascular events. Early and late events were recorded and analysed subsequently. RESULTS: In hospital 30-day MACCE occurred in 12 (4.6%) patients, including 7 (2.7%) strokes, 3 (1.1%) myocardial infarctions and two (0.8%) deaths. Transient ischaemic attacks were observed in 8 patients, pulmonary oedema in 3 cases, as well as a single episode of retinal artery embolisation and acute renal insufficiency. The incidence of 30-day MACCE was not significantly higher in the high-risk group (6.07 vs. 1.33%; NS), but the risk of any adverse event was significantly higher (p=0.03). There was no difference in stroke incidence between procedures with or without neuroprotection (2.27 vs. 3.22%; NS). There was no difference in risk of MACCE between angioplasty of cephalad artery and one-stage cephalad and coronary artery angioplasty procedure (3.6 vs. 5.5%; NS). During 50.3+/-20 months of follow-up there were 16 (7.1%) deaths, 9 (3.5%) strokes and 6 (2.3%) re-stenoses confirmed angiographically. One-year total survival and one-year MACCE-free survival rates according to the Kaplan-Meier analysis were 94.9% and 89.0%, showing a trend towards better outcome in the low-risk group (F-Cox=2.46; p=0.19 and F-Cox=2.17; p=0.09 respectively). CONCLUSIONS: Percutaneous transluminal angioplasty of cephalad arteries is safe and feasible, with a low periprocedural complication rate and good late outcome. Carotid artery stenting is an alternative method to CEA.