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1.
Folia Med Cracov ; 63(2): 65-75, 2023 Jul 30.
Artículo en Inglés | MEDLINE | ID: mdl-37903380

RESUMEN

Pelvic venous disorder (PeVD) is a prevalent chronic condition characterized by the presence of varicose veins in the pelvis, leading to the development of chronic pelvic pain. Despite the growing interest in assessing quality of life in PeVD, well-designed and validated disease-specific questionnaires are missing. The objective of this study was a linguistic and clinical validation of the Symptom Questionnaire (SQ) in a cohort of Polish females with pelvic vein incompetence. The Polish version of SQ was developed using a standardized validation process that involved a back-and- forth translation protocol. A total of 58 female patients diagnosed with pelvic varicose veins, representing diverse educational back- grounds, participated in the study. Multiple issues were observed during linguistic validation, primarily originating from disparities between the Polish and British healthcare systems, as well as differing levels of sexual health education of those two populations. Cronbach α was calculated separately for each part of the questionnaire with results exceeded 0.6 for each section. Test-retest analysis indicated most Pearson correlation coefficients surpassing 0.70. The absolute agreement consistency between pretest and post-test measures, evaluated using the Intra Class Correlation (ICC), exceeded 0.8 in three sections and 0.7 in the remaining three sections. However, the clinical validation failed due to the lack of standardized score calculation proposed by the authors of the questionnaire and inaccurately assigned values in the answer key for five questions. Consequently, the practical utility of SQ in daily clinical settings remains uncertain, highlighting the urgent need for the development of a new, user-friendly questionnaire specifically tailored to assess the quality of life in individuals with PeVD.


Asunto(s)
Calidad de Vida , Várices , Humanos , Femenino , Polonia , Pelvis , Várices/diagnóstico , Lingüística , Encuestas y Cuestionarios
2.
Catheter Cardiovasc Interv ; 94(1): 149-156, 2019 Jul 01.
Artículo en Inglés | MEDLINE | ID: mdl-30945420

RESUMEN

OBJECTIVES: To assess feasibility, safety, angiographic, and clinical outcome of highly-calcific carotid stenosis (HCCS) endovascular management using CGuard™ dual-layer carotid stents. BACKGROUND: HCCS has been a challenge to carotid artery stenting (CAS) using conventional stents. CGuard combines a high-radial-force open-cell frame conformability with MicroNet sealing properties. METHODS: The PARADIGM study is prospectively assessing routine CGuard use in all-comer carotid revascularization patients; the focus of the present analysis is HCCS versus non-HCCS lesions. Angiographic HCCS (core laboratory evaluation) required calcific segment length to lesion length ≥2/3, minimal calcification thickness ≥3 mm, circularity (≥3 quadrants), and calcification severity grade ≥3 (carotid calcification severity scoring system [CCSS]; G0-G4). RESULTS: One hundred and one consecutive patients (51-86 years, 54.4% symptomatic; 106 lesions) received CAS (16 HCCS and 90 non-HCCS); eight others (two HCCS) were treated surgically. CCSS evaluation was reproducible, with weighted kappa (95% CI) of 0.73 (0.58-0.88) and 0.83 (0.71-0.94) for inter- and intra-observer reproducibility respectively. HCCS postdilatation pressures were higher than those in non-HCCS; 22 (20-24) versus 20 (18-24) atm, p = .028; median (Q1-Q3). Angiography-optimized HCCS-CAS was feasible and free of contrast extravasation or clinical complications. Overall residual diameter stenosis was single-digit but it was higher in HCCS; 9 (4-17) versus 3 (1-7) %, p = .002. At 30 days and 12 months HCCS in-stent velocities were normal and there were no adverse clinical events. CONCLUSION: CGuard HCCS endovascular management was feasible and safe. A novel algorithm to grade carotid artery calcification severity was reproducible and applicable in clinical study setting. Larger HCCS series and longer-term follow-up are warranted.


Asunto(s)
Estenosis Carotídea/terapia , Procedimientos Endovasculares/instrumentación , Stents , Accidente Cerebrovascular/prevención & control , Calcificación Vascular/terapia , Anciano , Anciano de 80 o más Años , Angiografía , Enfermedades Asintomáticas , Estenosis Carotídea/complicaciones , Estenosis Carotídea/diagnóstico por imagen , Estenosis Carotídea/mortalidad , Procedimientos Endovasculares/efectos adversos , Estudios de Factibilidad , Femenino , Humanos , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Diseño de Prótesis , Factores de Riesgo , Índice de Severidad de la Enfermedad , Accidente Cerebrovascular/diagnóstico por imagen , Accidente Cerebrovascular/etiología , Factores de Tiempo , Resultado del Tratamiento , Calcificación Vascular/complicaciones , Calcificación Vascular/diagnóstico por imagen , Calcificación Vascular/mortalidad
3.
Circ Res ; 120(4): 670-680, 2017 Feb 17.
Artículo en Inglés | MEDLINE | ID: mdl-27903568

RESUMEN

RATIONALE: New therapies for refractory angina are needed. OBJECTIVE: Assessment of transendocardial delivery of bone marrow CD133+ cells in patients with refractory angina. METHODS AND RESULTS: Randomized, double-blinded, placebo-controlled trial enrolled 31 patients with recurrent Canadian Cardiovascular Society II-IV angina, despite optimal medical therapy, ≥1 myocardial segment with inducible ischemia in Tc-99m SPECT who underwent bone marrow biopsy and were allocated to cells (n=16) or placebo (n=15). Primary end point was absolute change in myocardial ischemia by SPECT. Secondary end points were left ventricular function and volumes by magnetic resonance imaging and angina severity. After 4 months, there were no significant differences in extent of inducible ischemia between groups (summed difference score mean [±SD]: 2.60 [2.6] versus 3.63 [3.6], P=0.52; total perfusion deficit: 3.60 [3.6] versus 5.01 [4.3], P=0.32; absolute changes of summed difference score: -1.38 [5.2] versus -0.73 [1.9], P=0.65; and total perfusion deficit: -1.33 [3.3] versus -2.19 [6.6], P=0.65). There was a significant reduction of left ventricular volumes (end-systolic volume: -4.3 [11.3] versus 7.4 [11.8], P=0.02; end-diastolic volume: -9.1 [14.9] versus 7.4 [15.8], P=0.02) and no significant change of left ventricular ejection fraction in the cell group. There was no difference in number of patients showing improvement of ≥1 Canadian Cardiovascular Society class after 1 (41.7% versus 58.3%; P=0.68), 4 (50% versus 33.3%; P=0.63), 6 (70% versus 50.0%; P=0.42), and 12 months (55.6% versus 81.8%; P=0.33) and use of nitrates after 12 months. CONCLUSION: Transendocardial CD133+ cell therapy was safe. Study was underpowered to conclusively validate the efficacy, but it did not show a significant reduction of myocardial ischemia and angina versus placebo. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01660581.


Asunto(s)
Antígeno AC133/administración & dosificación , Angina de Pecho/diagnóstico por imagen , Angina de Pecho/terapia , Trasplante de Médula Ósea/métodos , Endocardio/fisiología , Función Ventricular Izquierda/fisiología , Anciano , Angina de Pecho/epidemiología , Células de la Médula Ósea/fisiología , Canadá/epidemiología , Método Doble Ciego , Endocardio/citología , Femenino , Estudios de Seguimiento , Humanos , Imagen por Resonancia Magnética/métodos , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Tomografía Computarizada de Emisión de Fotón Único/métodos , Trasplante Autólogo/métodos , Resultado del Tratamiento
4.
Environ Res ; 172: 258-265, 2019 05.
Artículo en Inglés | MEDLINE | ID: mdl-30822558

RESUMEN

BACKGROUND: While European air quality policies reduce ambient carbon monoxide (CO) concentrations in general, there are still areas affected by high environmental CO exposure from transportation, industry and burning low-quality fossil fuels. We investigated, how these CO amounts might influence exhaled CO measurements used to monitor the smoking status of healthy subjects. METHODS: A cross-sectional study of healthy adults living in areas of high air pollution (N = 742) and low air pollution (N = 197) in Poland. They completed a survey regarding their smoking habits and underwent necessary body measurements including exhaled CO concentration levels. RESULTS: Ambient CO levels were much higher in highly pollutes cities. Also exhaled CO levels in subjects from high pollution areas were significantly higher, independent of subject smoking status (8.25 ppm vs. 3.26 ppm). Smokers exhaled more CO than non-smokers. Although the duration of smoking did not affect the CO levels, they were proportional to the number of cigarettes smoked during the day, especially for higher amounts of cigarettes and in unpolluted areas. It was possible to differentiate active from passive smokers in all areas, but the difference for passive smokers vs. non-smokers was significant only in low pollution city inhabitants. CONCLUSIONS: Exhaled CO levels were confirmed to be a good indicator of smoking status and smoking pattern in healthy subjects. However, high environmental CO levels both increase baseline exhaled CO concentrations in non-smokers affecting their discrimination from passive smokers, and obscure categorizing cigarette consumption in heavy smokers. These findings add important evidence on both understanding of exhaled CO monitoring results and a significance of environmental CO exposure in areas with high pollution.


Asunto(s)
Contaminación del Aire , Pruebas Respiratorias , Monóxido de Carbono , Contaminación por Humo de Tabaco , Adulto , Monóxido de Carbono/análisis , Ciudades , Estudios Transversales , Humanos , Polonia , Fumar , Contaminación por Humo de Tabaco/análisis
5.
Int J Environ Health Res ; 29(3): 290-300, 2019 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-30375883

RESUMEN

Carbon monoxide (CO) is an important component of tobacco smoke, but also environmental toxicity. This study analyzed possible correlation between exhaled CO level and oral health indicators in two geographically distributed populations during health-promoting public events organized for local communities in cities with high and low environmental pollution in Poland (907 patients). Self-reported, instructor-led, oral health questionnaire was developed to monitor current and previous mucosal lesion incidence. Exhaled CO correlated with subjects smoking status and environmental CO exposure: highest in smoking inhabitants of Krakow (12 ppm), with lower levels in smokers from Kozienice (6.5 ppm) and non-smokers from Krakow (6 ppm), and lowest for Kozienice non-smokers (2 ppm) (p < 0.001). After propensity score matching and adjustment for smoking status, demography and comorbidities odds ratio for mucosal lesion incidence was 1.46 (1.31-1.63), p < 0.001) per 1 ppm increase of exhaled CO level. This result might implicate a possible role of environmental pollution factors in oral health pathology.


Asunto(s)
Monóxido de Carbono/análisis , Enfermedades de la Boca/epidemiología , Mucosa Bucal/patología , Adulto , Contaminación del Aire , Comorbilidad , Espiración , Femenino , Humanos , Incidencia , Masculino , Persona de Mediana Edad , Oportunidad Relativa , Polonia , Fumar/epidemiología , Encuestas y Cuestionarios , Adulto Joven
6.
Clin Immunol ; 194: 26-33, 2018 09.
Artículo en Inglés | MEDLINE | ID: mdl-29936303

RESUMEN

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.


Asunto(s)
Linfocitos T CD8-positivos/inmunología , Enfermedad Arterial Periférica/inmunología , Subgrupos de Linfocitos T/inmunología , Lesiones del Sistema Vascular/inmunología , Anciano , Antígenos CD/inmunología , Femenino , Humanos , Memoria Inmunológica/inmunología , Antígenos Comunes de Leucocito/inmunología , Masculino , Receptores de Antígenos de Linfocitos T alfa-beta/inmunología
7.
Catheter Cardiovasc Interv ; 92(2): 302-309, 2018 08 01.
Artículo en Inglés | MEDLINE | ID: mdl-29027737

RESUMEN

OBJECTIVES: The aim of the study was to capture the evolution of neointima after implantation of a biodegradable polymer-coated, sirolimus-eluting, cobalt-chromium coronary stent system (BP-DES). BACKGROUND: Optical coherence tomography (OCT) suggests that in-stent neointimal morphology influences clinical outcomes after DES implantation. METHODS: Sixty patients treated with single BP-DES implantation were examined by quantitative coronary angiography (QCA) and OCT at 3, 6, and 12-month follow-up. RESULTS: Median late lumen loss by QCA (mm) was 0.04 (IQR 0, 0.08), 0.17 (IQR 0, 0.32), and 0.14 (IQR 0.07, 0.31) at 3, 6, and 12-month follow-up respectively (P = 0.03). OCT cross-section multilevel analysis showed uncovered struts in 3.90%, 1.78%, and 0.02% of struts respectively (P = 0.03). The corresponding malapposition rates were 0.12%, 0.04%, and 0%. Lipid-rich neointima was observed only at 12-month follow-up in one restenotic lesion (0.77% cross-sections) that was accountable for the only target vessel revascularization. The homogeneous pattern was prevalent at all three time points, but its incidence displayed an upward trend (3 months: 59%; 6 months: 71%; 12 months: 88%) despite no difference in neointimal volume between 6 and 12 months. Conversely, a trend could be observed of decreasing incidence of heterogeneous pattern as the follow-up length increased. CONCLUSIONS: In this study of a single-type BP-DES, the majority of stent struts were covered within 3 months from implantation. While the quantitative neointimal accumulation plateaued at 6 months with no further significant increase beyond 6 months, the neointima continued to evolve qualitatively and mature along with better strut coverage between 6 and 12 months after implantation.


Asunto(s)
Implantes Absorbibles , Fármacos Cardiovasculares/administración & dosificación , Enfermedad de la Arteria Coronaria/cirugía , Vasos Coronarios/cirugía , Stents Liberadores de Fármacos , Neointima , Intervención Coronaria Percutánea/instrumentación , Sirolimus/administración & dosificación , Tomografía de Coherencia Óptica , Anciano , Fármacos Cardiovasculares/efectos adversos , Aleaciones de Cromo , Angiografía Coronaria , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Vasos Coronarios/diagnóstico por imagen , Femenino , Humanos , Masculino , Persona de Mediana Edad , Intervención Coronaria Percutánea/efectos adversos , Polonia , Valor Predictivo de las Pruebas , Estudios Prospectivos , Diseño de Prótesis , Factores de Riesgo , Sirolimus/efectos adversos , Factores de Tiempo , Resultado del Tratamiento
8.
Ann Vasc Surg ; 31: 111-23, 2016 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-26616505

RESUMEN

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.


Asunto(s)
Atención a la Salud/economía , Procedimientos Endovasculares/economía , Costos de Hospital , Isquemia/economía , Isquemia/terapia , Programas Nacionales de Salud/economía , Evaluación de Procesos y Resultados en Atención de Salud/economía , Enfermedad Arterial Periférica/economía , Enfermedad Arterial Periférica/terapia , Anciano , Anciano de 80 o más Años , Amputación Quirúrgica/economía , Análisis Costo-Beneficio , Enfermedad Crítica , Supervivencia sin Enfermedad , Procedimientos Endovasculares/efectos adversos , Procedimientos Endovasculares/instrumentación , Procedimientos Endovasculares/mortalidad , Femenino , Humanos , Reembolso de Seguro de Salud , Isquemia/diagnóstico , Isquemia/mortalidad , Estimación de Kaplan-Meier , Tiempo de Internación/economía , Recuperación del Miembro/economía , Masculino , Persona de Mediana Edad , Readmisión del Paciente/economía , Enfermedad Arterial Periférica/diagnóstico , Enfermedad Arterial Periférica/mortalidad , Polonia , Estudios Retrospectivos , Factores de Riesgo , Stents/economía , Centros de Atención Terciaria/economía , Factores de Tiempo , Resultado del Tratamiento
10.
Catheter Cardiovasc Interv ; 85(1): E16-22, 2015 Jan 01.
Artículo en Inglés | MEDLINE | ID: mdl-24909662

RESUMEN

BACKGROUND: Current STEMI guidelines recommend thrombectomy should be considered during primary PCI. Multiple data from randomized clinical trials, registries, and metanalysis have confirmed the efficacy of thrombectomy in terms of surrogate endpoints like better myocardial perfusion, less pronounced distal embolization, and conflicting results on lower all-cause mortality. Our aim was to analyze long-term outcome of STEMI patients treated with manual thrombectomy during primary PCI in a contemporary national registry. METHODS: There were 13 catheterization laboratories in Poland that enrolled patients in NRDES Registry. Patients were divided into two groups: those that were treated with manual thrombectomy for their primary PCI vs. those who were not. RESULTS: There were altogether 2,686 patients enrolled in the NRDES Registry of whom 1,763 were diagnosed with STEMI (66%). Aspiration thrombectomy was used in 673 of these cases (38%) and 1,090 (62%) patients were treated without thrombectomy during the index primary PCI. Overall mortality at 1 year was 11.03% in thrombectomy and 7.46% in no thrombectomy group respectively (P = 0.0292 which became insignificant after propensity score matching adjustment P = 0.613). Specific subgroup analyses revealed that there was no benefit from aspiration thrombectomy in neither subgroup. CONCLUSIONS: Manual aspiration thrombectomy in patients undergoing primary PCI for STEMI was not associated with improved long-term 1-year clinical outcome. Subgroup analysis did not reveal any specific setting in which thrombectomy would be clinically superior. © 2014 Wiley Periodicals, Inc.


Asunto(s)
Trombosis Coronaria/terapia , Infarto del Miocardio/terapia , Intervención Coronaria Percutánea , Trombectomía/métodos , Anciano , Distribución de Chi-Cuadrado , Angiografía Coronaria , Trombosis Coronaria/diagnóstico , Trombosis Coronaria/mortalidad , Femenino , Humanos , Estimación de Kaplan-Meier , Masculino , Persona de Mediana Edad , Infarto del Miocardio/diagnóstico , Infarto del Miocardio/mortalidad , Oportunidad Relativa , Intervención Coronaria Percutánea/efectos adversos , Intervención Coronaria Percutánea/mortalidad , Polonia , Puntaje de Propensión , Sistema de Registros , Factores de Riesgo , Succión , Trombectomía/efectos adversos , Trombectomía/mortalidad , Factores de Tiempo , Resultado del Tratamiento
11.
Catheter Cardiovasc Interv ; 83(3): 436-42, 2014 Feb 15.
Artículo en Inglés | MEDLINE | ID: mdl-24038740

RESUMEN

OBJECTIVES: To analyze long-term outcome of ST-Elevation Myocardial Infarction (STEMI) and non-STEMI (NSTEMI) patients treated with Drug Eluting Stents (DES) stents with regard to mortality and stent thrombosis rates based on the national Polish PCI registry database. BACKGROUND: Only a few studies suggested potential trend towards lower mortality in STEMI patients treated with DES. Current European Society of Cardiology STEMI guidelines recommend DES use only with one restriction to suspected patient poor compliance or contraindication to dual antiplatelet therapy. METHODS: Thirteen high-volume interventional cardiology centers in Poland enrolled patients in National Registry of Drug Eluting Stents (NRDES) Registry from October 2010 till October 2011. RESULTS: There were 2686 patients enrolled in NRDES Registry. Eighty five patients (3%) had both DES and BMS implanted at index PCI procedure and were excluded from further analysis. A subpopulation of STEMI (1709; 66%) and NSTEMI (892; 34%) patients was selected for BMS vs DES comparison. A significant difference in favor of DES group for 1-year mortality was found in STEMI subgroup (P < 0.0001-unadjusted and P = 0.0497 after propensity score adjustment). No such differences were noticed for NSTEMI subgroup or stent thrombosis comparisons. CONCLUSIONS: A strong selection bias for DES stents was observed with regard to demographic and angiographic characteristics in both STEMI and NSTEMI. DES implantation was associated with similar ischemic outcome to BMS at 1-year follow-up. STEMI patients with DES presented a trend towards lower long-term mortality at 1 year in comparison to BMS.


Asunto(s)
Stents Liberadores de Fármacos , Metales , Infarto del Miocardio/terapia , Intervención Coronaria Percutánea/instrumentación , Stents , Anciano , Angiografía Coronaria , Reestenosis Coronaria/etiología , Reestenosis Coronaria/mortalidad , Trombosis Coronaria/etiología , Trombosis Coronaria/mortalidad , Femenino , Humanos , Estimación de Kaplan-Meier , Masculino , Persona de Mediana Edad , Infarto del Miocardio/diagnóstico , Infarto del Miocardio/mortalidad , Intervención Coronaria Percutánea/efectos adversos , Intervención Coronaria Percutánea/mortalidad , Inhibidores de Agregación Plaquetaria/uso terapéutico , Polonia , Puntaje de Propensión , Sistema de Registros , Factores de Riesgo , Factores de Tiempo , Resultado del Tratamiento
14.
Indian Heart J ; 65(4): 388-94, 2013.
Artículo en Inglés | MEDLINE | ID: mdl-23992999

RESUMEN

AIMS: Evaluation of safety and efficacy of ProNOVA XR, a new generation of polymer-free sirolimus eluting stents (SES), utilizing a pharmaceutical excipient for timed release of sirolimus from the XR platform. METHODS AND RESULTS: Safety and efficacy of ProNOVA XR coronary stent system was examined in EURONOVA prospective, single arm, multi-center registry of 50 patients with de novo native coronary lesions up to 28 mm in length in arteries between 2.25 and 4 mm. At 6-month, in-stent late lumen loss by QCA was 0.45 ± 0.41 mm and in-stent neointimal volume obstruction in the IVUS sub-study was 14 ± 11%. One-year clinical follow-up revealed a favorable safety profile, with 2% of in-hospital MACE and 6.4% of MACE from hospital discharge up to 12 months (including 1 cardiac death >30 days after stent implantation and 2 TLRs). According to the ARC definition, there was no definite or probable stent thrombosis and 1 possible stent thrombosis (2%) up to 12 months of clinical follow-up. CONCLUSIONS: In this preliminary evaluation, ProNOVA XR polymer-free sirolimus eluting stent system appeared safe with an early promise of adequate effectiveness in the treatment of de novo coronary lesions in up to 12 months of clinical, angiographic and IVUS follow-up.


Asunto(s)
Enfermedad de la Arteria Coronaria/tratamiento farmacológico , Stents Liberadores de Fármacos , Sirolimus/administración & dosificación , Comorbilidad , Angiografía Coronaria , Excipientes/farmacología , Femenino , Humanos , Ácido Láctico/farmacología , Masculino , Persona de Mediana Edad , Ácido Poliglicólico/farmacología , Copolímero de Ácido Poliláctico-Ácido Poliglicólico , Estudios Prospectivos , Resultado del Tratamiento , Ultrasonografía Intervencional
15.
Postepy Kardiol Interwencyjnej ; 19(2): 171-177, 2023 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-37465629

RESUMEN

Introduction: One of the most popular tests of the heart is the electrocardiogram (ECG). The physical basis of this study has been known for over 200 years. However, the way an ECG is performed and the interpretation of the obtained results have undergone considerable evolution over time. Aim: To analyze the ECG recordings regarding the QTc interval in patients taking calcium channel blockers. Material and methods: The publicly available PhysioNet signals database was used to analyze the effect of selected drugs on the heart rhythm and QTc interval. To automate the QTc assessment, the database was processed in MATLAB. First, QTc was assessed using four formulas; then the results were compared in terms of methodology and medications taken. Results: In the group of patients taking dihydropyridine blockers, the QTc interval assessed by the Bazett formula (mean: 478.87 ms; SD: 73.10) is longer than in patients taking non-dihydropyridine blockers (mean: 446.54 ms, SD: 88.07, p = 0.2123) and in patients not taking calcium channel blockers (mean: 436.33 ms, SD: 49.94, p = 0.0319). The same significant differences were obtained regardless of the QTc assessment method used. However, the QTc result obtained with the Bazett formula is significantly lower than in the case of using the other three formulas used for the presented analysis. Conclusions: Automatic ECG analysis is possible; however, it should be used carefully, considering the possibility of obtaining incorrect results. Taking calcium channel blockers may affect the QTc interval. QTc results significantly depend on the formula based on which we evaluate this parameter.

16.
Postepy Kardiol Interwencyjnej ; 18(2): 118-121, 2022 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-36051833

RESUMEN

Introduction: Some patients with coronary heart disease are diagnosed with severe aortic stenosis. For further treatment, coronary angiography is performed in these patients. For intermediate lesions, obtaining coronary artery physiological data can facilitate clinical decision-making regarding revascularization. Aim: The study compared the physiological significance of coronary artery stenosis using the fractional flow reserve (FFR) method with instantaneous wave-free pressure ratio (iFR) and quantitative flow ratio (QFR) in patients qualified for aortic valve replacement. Material and methods: Data were collected on patients hospitalized in the years 2019-2020 at the 2nd Department of Cardiology, University Hospital in Krakow. Results: Twelve patients with severe aortic stenosis and borderline lesions in the coronary artery were qualified for physiological assessment. There were 6 women, whose mean age was 73.8 ±7.5 years. The mean left ventricular ejection fraction was 52 ±15%. The mean aortic valve area was 0.80 ±0.16 cm2. The left anterior descending artery was assessed in 12 from 13 cases (92%). In comparison to FFR, all iFR measurements were concordant with FFR. The total agreement between QFR and FFR/iFR assessment was 69%. Conclusions: Despite the controversy and uncertainty of some operators regarding the interpretation of the FFR test in patients with severe aortic stenosis, we obtained complete agreement of FFR with iFR assessment. This fact suggests that in patients with severe aortic stenosis the choice of an invasive method to assess the physiological significance of the stenosis in the coronary artery is not crucial - both iFR and FFR allow comparable results.

17.
Postepy Kardiol Interwencyjnej ; 18(2): 131-136, 2022 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-36051830

RESUMEN

Introduction: Percutaneous coronary intervention (PCI) is a common method of treatment for patients with coronary artery disease. One of the most common complications during the PCI procedure is coronary artery dissection. It usually requires an additional action to assure the patency of the treated vessel. Aim: The aim of the publication is to describe the occurrence of coronary artery dissection after bioresorbable vascular scaffold (BVS) implantation. This selected type of PCI procedure is especially interesting because precise target vessel measurement before BVS implantation is required for optimal determination of scaffold size. Material and methods: Based on angiographic data gathered in the POLAR ACS Registry, we assessed the frequency of dissections, their localization, and severity. Based on data regarding patients' demographic, clinical status, and details regarding treatment strategy, the factors that could have an influence on the dissection occurrence were identified. Results: A group of 100 patients included in the analyses. Group A consisted of 9 patients. This group was defined as patients in whom the significant dissection occurred after the BVS implantation. Group B comprised 91 patients. Both groups were very similar according to demographic data. The frequency of predilatation was similar; post-dilatation was performed more often in group A but without statistical significance. The presence of calcification in the target lesion was an independent factor of dissection during the index PCI procedure. Conclusions: The occurrence of significant dissection can be effectively treated, and the good angiographic results of this treatment immediately after the initial procedure translate into good clinical results in longer follow-up.

18.
Am J Cardiol ; 155: 23-31, 2021 09 15.
Artículo en Inglés | MEDLINE | ID: mdl-34315572

RESUMEN

Data on long-term neointimal healing and neoatherosclerosis progression after primary percutaneous coronary intervention (PCI) with implantation of everolimus-eluting bioresorbable vascular scaffold (BVS) (ABSORB BVS 1.0, Abbott Vascular) are limited. The mechanisms underlying very late scaffold failure remain to be further elucidated. This study sought to assess healing pattern and presence of neoatherosclerosis. This was a single-center, prospective, longitudinal study with serial optical coherence tomography (OCT) assessment at baseline, 12, 24 and 60 months after PCI performed in 12 patients presenting with ST-segment elevation myocardial infarction (STEMI). The median follow-up was 59 months. The diameter stenosis increased from 7.11 ± 4.99% at 1-year to 21.00 ± 11.31% at 5 years, (p = 0.03), whereas minimum lumen diameter remained stable throughout the follow-up period, as assessed by angiography. Minimum and mean lumen area declined over the 5-year follow-up by 1.00 ± 1.57 mm2 and 1.75 ± 0.87 mm2, respectively; a significant decrease in minimum and mean lumen area in the first two years, was followed by stable luminal dimensions between 2 and 5 years of follow-up. The lumen eccentricity (0.85 ± 0.03) and asymmetry (0.43 ± 0.10) indexes showed no change over 60-month follow-up. The incidence of atherosclerosis was high both in the in-scaffold (IS) and out-scaffold (OS) regions consisting of calcifications (IS = 100%, OS = 92%, p = 0.99), macrophages (IS = 92% and OS = 67%, p = 0.31), neovascularization (IS = 75%, OS = 50%, p = 0.40). In conclusion, serial OCT imaging up to 5 years after implantation of BVS in STEMI indicated complete scaffold resorption, stable lumen area following period of neointima growth in the first two years after PCI and high incidence of neoatherosclerosis.


Asunto(s)
Implantes Absorbibles , Vasos Coronarios/diagnóstico por imagen , Stents Liberadores de Fármacos , Intervención Coronaria Percutánea/métodos , Infarto del Miocardio con Elevación del ST/diagnóstico , Andamios del Tejido , Tomografía de Coherencia Óptica/métodos , Angiografía Coronaria , Vasos Coronarios/cirugía , Femenino , Estudios de Seguimiento , Humanos , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Diseño de Prótesis , Infarto del Miocardio con Elevación del ST/cirugía , Factores de Tiempo , Resultado del Tratamiento
19.
Kardiol Pol ; 68(5): 539-43, 2010 May.
Artículo en Inglés | MEDLINE | ID: mdl-20491016

RESUMEN

BACKGROUND: Primary percutaneous coronary intervention (PCI) is the preferred method of reperfusion in patients with ST elevation myocardial infarction (STEMI). Abciximab is a well established adjunct to primary PCI. The proper timing of abciximab administration in STEMI patients has been investigated in randomised trials, registries and metanalysis, providing conflicting results. METHODS: Consecutive data on STEMI patients, transferred for primary PCI in hospital/ambulance STEMI networks between November 2005 and January 2007, from 15 PCI centres in seven European countries was gathered together for a one-year long-term clinical observation (93% rate of completeness). RESULTS: Data from 1,650 patients was collected in the EUROTRANSFER Registry. Abciximab was administered to 1,086 patients (66%), 727 patients received early (at least 30 minutes prior to first balloon inflation) abciximab (EA), and another 359 patients received late abciximab (LA). One year mortality was 5.8% in the EA group vs 10.3% with LA (p = 0.007). Adjustment for propensity score methods for EA administration did not change the results, still providing a favourable outcome for the EA group (p = 0.004). It was also revealed that only a minority of patients (36%) were treated within the 90-minute recommended time window from first medical contact to PCI (and 60% for the 120-min time delay). CONCLUSIONS: Patients transferred for primary PCI in STEMI hospital networks showed lower rates of death in long-term one-year clinical follow-up when treatment with abciximab was started early.


Asunto(s)
Angioplastia Coronaria con Balón , Anticuerpos Monoclonales/administración & dosificación , Fragmentos Fab de Inmunoglobulinas/administración & dosificación , Infarto del Miocardio/terapia , Inhibidores de Agregación Plaquetaria/administración & dosificación , Sistema de Registros/estadística & datos numéricos , Abciximab , Adulto , Anciano , Anciano de 80 o más Años , Terapia Combinada , Esquema de Medicación , Electrocardiografía , Europa (Continente)/epidemiología , Femenino , Estudios de Seguimiento , Humanos , Masculino , Persona de Mediana Edad , Infarto del Miocardio/diagnóstico , Infarto del Miocardio/mortalidad , Análisis de Supervivencia , Resultado del Tratamiento
20.
Radiol Case Rep ; 15(11): 2445-2448, 2020 Nov.
Artículo en Inglés | MEDLINE | ID: mdl-33005282

RESUMEN

Juvenile idiopathic arthritis (JIA) is a group of childhood inflammatory arthropathies that affects multiple joints including the spine, particularly the cervical region. There is paucity of literature regarding JIA in the lumbosacral spine; the few published studies which discuss imaging findings in the lumbosacral spine only include cohorts of older children and adolescents. We present a 22-month-old boy with refusal to walk, in which plain radiographs and contrast-enhanced magnetic resonance imaging of the lumbosacral spine suggested a diagnosis of JIA.

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