Balazs Berta

BackgroundThe aim of this prospective registry was to determine the feasibility, safety, and outcomes of percutaneous transluminal angioplasty and thrombolysis in the treatment of critical hand ischemia (CHI).MethodsOne‐hundred one patients (aged 60.6 ± 15.3 years) were treated for CHI between 2012 and 2016 in three cardiovascular centers. Anatomically, the upper arm was divided into three segments (I‐subclavian, II‐brachial, and III‐forearm). We examined the rates of technical and clinical success, major adverse events (MAEs), and vascular complications at 1 year and at long‐term follow‐up.ResultsNineteen patients (18.8%) were treated for acute CHI, and 82 (81.2%) for chronic CHI. Median follow‐up was 36.9 (19.6–68.3) months. Clinical symptoms were isolated rest pain in 91 patients (90.1%) and digital ulcer or gangrene in 10 patients (9.9%). The technical and clinical success rate of intervention was 96.0% (97/101) and 84.2% (85/101) at 1 year. Angioplasty was performed in Segments...

Limited data exist on radial access in carotid artery stenting. This multicentre prospective randomised study was performed to compare the outcome and complication rates of transradial and transfemoral carotid artery stenting. The clinical and angiographic data of 260 consecutive patients with high risk for carotid endarterectomy, treated between 2010 and 2012 by carotid stenting with cerebral protection, were evaluated. Patients were randomised to transradial (n=130) or transfemoral (n=130) groups and several parameters were evaluated. Primary combined endpoint: major adverse cardiac and cerebral events, rate of access-site complications. Secondary endpoints: angiographic outcome of the procedure, fluoroscopy time and X-ray dose, procedural time, crossover rate to another puncture site and hospitalisation in days. Procedural success was achieved in all 260 patients (100%), the crossover rate was 10% in the TR and 1.5% in the TF group (p<0.05). A major access-site complication was encountered in one patient (0.9%) in the TR group and in one patient (0.8%) in the TF group (p=ns). The incidence of major adverse cardiac and cerebral events was 0.9% in the TR and 0.8% in the TF group (p=ns). Procedure time (1,620 [1,230-2,100] vs. 1,500 [1,080-2,100] sec, p=ns) and fluoroscopy time (540 [411-735] vs. 501 [378-702] sec, p=ns) were not significantly different, but the radiation dose was significantly higher in the TR group (195 [129-274] vs. 148 [102-237] Gy*cm2, p<0.05) by per-protocol analysis. Hospitalisation days were significantly lower in the TR group (1.17±0.40 vs. 1.25±0.45, p<0.05). By intention-to-treat analysis there was a significantly higher radiation dose in the TR group (195 [130-288] vs. 150 [104-241], p<0.05), but no difference in major events (0.9 vs. 0.8, p=ns) and length of hospitalisation in days (1.4±2.6 vs. 1.25±0.45, p=ns). The transradial approach for carotid artery stenting is safe and efficacious; however, the crossover rate is higher with transradial access. There are no differences in the total procedure duration and fluoroscopy time between the two approaches but the radiation dose is significantly higher in the radial group, and the hospitalisation is shorter with the use of transradial access by per-protocol analysis. By evaluating the patient data according to intention-to-treat analysis we found no difference in major adverse events and hospitalisation. In both groups, vascular complications rarely occurred.

Aims To study if any qualitative or quantitative optical coherence tomography (OCT) variables in combination with thin cap fibroatheroma (TCFA) patients could improve the identification of lesions at risk for future major adverse cardiac events (MACEs). Methods and results From the combined optical coherence tomography morphologic and fractional flow reserve hemodynamic assessment of non- culprit lesions to better predict adverse event outcomes in diabetes mellitus patients: COMBINE (OCT-FFR) trial database (NCT02989740), we performed a detailed assessment OCT qualitative and quantitative variables in TCFA carrying diabetes mellitus (DM) patients with vs. without MACE during follow-up. MACEs were defined as a composite of cardiac death, target vessel myocardial infarction, clinically driven target lesion revascularization, and hospitalization for unstable angina. From the 390 fractional flow reserve (FFR)-negative DM patients, 98 (25.2%) had ≥1 OCT-detected TCFA, of which 13 (13.3%)...

Background: Autopsy studies have established that thin-cap fibroatheromas (TCFAs) are the most frequent cause of fatal coronary events. In living patients, optical coherence tomography (OCT) has sufficient resolution to accurately differentiate TCFA from thick-cap fibroatheroma (ThCFA) and not lipid rich plaque (non-LRP). However, the impact of OCT-detected plaque phenotype of nonischemic lesions on future adverse events remains unknown. Therefore, we studied the natural history of OCT-detected TCFA, ThCFA, and non-LRP in patients enrolled in the prospective multicenter COMBINE FFR-OCT trial (Combined Optical Coherence Tomography Morphologic and Fractional Flow Reserve Hemodynamic Assessment of Non-Culprit Lesions to Better Predict Adverse Event Outcomes in Diabetes Mellitus Patients). Methods: In the COMBINE FFR-OCT trial, patients with diabetes and ≥1 lesion with a fractional flow reserve >0.80 underwent OCT evaluation and were clinically followed for 18 months. A composite pri...

Aims The aim of this study was to understand the impact of optical coherence tomography (OCT)-detected thin-cap fibroatheroma (TCFA) on clinical outcomes of diabetes mellitus (DM) patients with fractional flow reserve (FFR)-negative lesions. Methods and results COMBINE OCT-FFR study was a prospective, double-blind, international, natural history study. After FFR assessment, and revascularization of FFR-positive lesions, patients with ≥1 FFR-negative lesions (target lesions) were classified in two groups based on the presence or absence of ≥1 TCFA lesion. The primary endpoint compared FFR-negative TCFA-positive patients with FFR-negative TCFA-negative patients for a composite of cardiac mortality, target vessel myocardial infarction, clinically driven target lesion revascularization or unstable angina requiring hospitalization at 18 months. Among 550 patients enrolled, 390 (81%) patients had ≥1 FFR-negative lesions. Among FFR-negative patients, 98 (25%) were TCFA positive and 292 (75...

Thin fibrous cap atheroma (TCFA), plaque rupture (PR), plaque erosion (PE) triggers the acute coronary syndrome. However, the prevalence of these plaques in non-ischemic lesions in diabetes mellitus (DM) patients was barely reported. This report presents the distribution of high-risk plaques in non-

To explore the predictors of deferred lesion failure (DLF) in patients with diabetes mellitus (DM) and lesions with a fractional flow reserve (FFR) >0.80 and to examine whether a predictive relationship between negative FFR values (>0.80-1.00) and DLF exists. DM is associated with rapidly progressive atherosclerosis and predictors of DLF in FFR negative lesions in this high-risk group are unknown. All DM patients who underwent FFR-assessment between 1/01/2010 and 31/12/2013 were included, and followed until 1/7/2015. Patients carrying ≥1 FFR negative lesion(s) were assessed for DLF, and multivariate models used to identify independent factors associated with DLF. A total of 205 patients with 252 FFR >0.80 lesions were identified. At a mean follow-up of 3.1 ± 1.4 years, DLF occurred in 29/205 (14.1%) patients, 31/252 (12.3%) lesions. Using marginal Cox regression multivariate analysis, insulin requiring DM [HR 2.24 (95%CI; 1.01-4.95), P = 0.046] and prior revascularization [...

Background. In-stent restenosis (ISR) is the gradual narrowing of the vessel lumen after coronary stent implantation due to the increase in vascular smooth muscle cell proliferation. Vascular endothelial growth factor (VEGF) protein plays an important role in this process. Our aim was to analyze the association of single nucleotide polymorphisms of the VEGF gene (rs2010963 and rs6999447) with the occurrence of ISR after coronary artery bare metal stent (BMS) implantation. Methods. 205 patients with a history of BMS implantation and a repeated coronarography were prospectively enrolled. Patients were assigned to diffuse restenosis group (n = 105) and control group (n = 100) and VEGF genotypes were determined. Results. Diffuse ISR was significantly more frequently observed in patients with homozygous normal genotype of rs2010963 polymorphism, and this polymorphism was independently associated with diffuse ISR. Conclusions. RS2010963 is associated with higher incidence of development o...

At present the main cause of death originates from cardiovascular diseases. Primarily the most frequent cause is vessel closing thus resulting in tissue damage. The stent can help to avoid this. It expands the narrowed vessel section and allows free blood flow. The good surface quality of stents is important. It also must have adequate mechanical characteristics or else it can be damaged which can easily lead to the fracture of the implant. Thus, we have to consider the importance of the surface treatment of these implants. In our experiments the appropriate design was cut from a 1.041 mm inner diameter and 0.100 mm wall thickness nitinol tube by using Nd:YAG laser device. Then, the stent was subjected to chemical etching. By doing so, the burr created during the laser cutting process can be removed and the surface quality refined. In our research, we changed the time of chemical etching and monitored the effects of this parameter. The differently etched stents were subjected to mic...

Purpose: The purpose of this pilot study was to evaluate the acute success and complication rate of the transradial access for iliac artery stenting using sheathless guiding. Methods: The clinical and angiographic data of 19 consecutive patients with symptomatic iliac artery stenosis treated via transradial access using 8.5F sheathless guiding between 2012 and 2013 were evaluated in a pilot study. There were no exclusion criteria. All patients underwent Duplex ultrasound before and after the intervention. Primary endpoint: major adverse events (MAE), rate of major and minor access site complications. Secondary endpoints: angiographic outcome of the iliac artery intervention, consumption of the angioplasty equipment, fluoroscopy time and X Ray dose, procedural time, cross over rate to another puncture site and hospitalisation in days. Transradial cases were performed by two operatours skilled in transradial technique. Results: Procedural success was achieved in 19 patients (100%) and...

ABSTRACT Background Percutaneous thrombectomy and catheter directed thrombolysis (CDT) represent well established techniques for treatment of submassive pulmonary embolism (SPE). The purpose of CDT is to dissolve thrombus and to restore the lumen without causing distal embolization as fast as possible. Methods We have enrolled in 2011-2013 our patients with SPE in a prospective register and we have analysed our patients clinical, interventional and echocardiographic data. We have examined the efficacy and safety of CDT in the treatment of SPE. The access site for SPE was the femoral. Caval filters were implanted from jugular or from femoral veins. After the sheath advancement, occlusions were passed with a 0.035 guidewire and CDT was started with Alteplase over a pig tail catheter for 12-24 hours. After 24 hours, control pulmonary angiography was performed and the CDT was maintained when the thrombus burden was flow limiting or the pulmonary pressure has not decreased with 50%. When the CDT was not successful, manual thrombectomy and thrombus fragmentation was performed with a 7F guiding and pig tail catheter. Postoperatively, patients were treated with systemic anticoagulation, compression hose, and interval follow-up. Results 26 patients were treated with a mean age of 52.5±14.9 years. CDT was successful after the first post-operative day in 19 patients (73%) but in 7 patients (27%) thrombus aspiration and thrombectomy was performed after failed thrombolysis. In two patients (7.2%) caval filters were implanted. Good angiographic and clinical outcome was achieved in 25 patients (96.15%). The invasive pulmonary pressure has dropped from 60.78 ± 18.67 to 19.7 ± 12.36 Hgmm after the procedure (p< 0.05). Echocardiography parameters were normalized in 25 patients (96.15). 30 day mortality occurred in one patient (3.85%) due to paradox embolism and mesenteric ischemia. Access site complications occurred in 2 patients (7.7%). Conclusions Submassive pulmonary embolism ha excellent results with catheter directed thrombolysis, however additional mechanical thrombectomy and angioplasty is necessary in several patients to achive good clinical outcome.

Background: Although circular ventricle resection techniques are the gold standard of left ventricle restoration, these techniques can lead to suboptimal results. Postoperative systolic resection line can be inadequate, as it must be planned on a heart stopped in diastole. The impaired geometry and contractility may lead to increased short- and long-term mortality. Moreover, postoperative low cardiac output due to insufficient left ventricular volume results in a potentially unstable condition, and cannot be corrected. Our aim was to find a preoperative method to minimize risk and maximize outcome with left ventricle restoration. Methods: We have created a novel method combining surgery with modern imaging techniques to construct a preoperative 3D systolic heart model. The model was utilized to determine resection could be intraoperatively used to create the new left ventricle. Results: The computer assisted ventricle engineering technique is described step by step through a success...

Although circular ventricular resection techniques are the gold standard of left ventricular (LV) restoration, these techniques can lead to suboptimal results. Postoperative systolic resection can be inadequate, because it must be planned on a heart stopped in diastole. Low cardiac output due to insufficient LV volume results in a potentially unstable condition, and cannot be corrected. Our aim was to find a preoperative method to minimize risk and maximize outcome with ventricular restoration. We created a novel method combining surgery with gadolinium-enhanced magnetic resonance to construct a preoperative 3D systolic heart model. The model was utilized to determine resection points that could be intraoperatively used. According to our calculations with the predetermined resection line, the calculated percentage reduction in LV volume was above 30%, and LV volumes were predicted above normal values; thus, performing the operation using these resection points is likely to be safe a...

In spite of improving results, the treatment of in-stent restenosis (ISR) of bare-metal stents (BMS), and particularly drug-eluting stents (DES), is a challenging clinical problem. There are promising but limited follow-up data concerning drug-eluting balloons in the treatment of BMS and DES restenosis. The goal of this real-world registry was to assess the long-term safety and efficacy of drug-eluting balloons in the treatment of BMS and DES restenosis. In this prospective registry, 82 patients with BMS or DES restenosis treated with paclitaxel-eluting balloons were enrolled. The primary endpoint was ischemia-driven target lesion revascularization (TLR); a secondary endpoint was the rate of major adverse cardiac events (MACE) at 28 months. Thirty-five patients (42.7%) had DES ISR and 16 patients (19.5%) presented with an acute coronary syndrome. The success rate of drug-eluting balloon inflation was 97.6%. The median (interquartile range) duration of follow up was 28.0 (25.0-30.3) ...