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Background and purpose - There is a lack of information on any associations between the functional outcome and age and diagnosis in patients who have undergone shoulder arthroplasty. We therefore evaluated the functional outcome in "young" and "old" patients treated with either hemiarthroplasty (HA) or total shoulder arthroplasty (TSA) with diverse diagnoses. Patients and methods - The functional results of 496 primary shoulder arthroplasties were analyzed using the Constant score (age- and sex-adjusted) and subjective satisfaction. Patients ≤55 years of age at surgery were defined as "young. Diagnoses were primary osteoarthritis (n = 339), posttraumatic osteoarthritis (n = 78), cuff tear arthropathy (n = 36), avascular necrosis (n = 30), and rheumatoid arthritis (n = 13). Mean length of follow-up was 4 (2-14) years. Results - 70% of the TSA patients were very satisfied with the postoperative result, as compared to 39% after HA. The Constant score and patient satisfaction were similar in the "young" and "old" groups. Pain relief was better in the "old" group. The mean improvement in the Constant score after cuff tear arthropathy (22 points) was inferior to that for primary osteoarthritis (36 points), avascular necrosis (34 points), and rheumatoid arthritis (37 points). Inferior mean Constant scores were also seen for posttraumatic osteoarthritis (29 points) compared to primary osteoarthritis (36 points). 63% of patients with primary osteoarthritis were very satisfied, as compared to only 36% of the patients with posttraumatic osteoarthritis. Interpretation - Shoulder arthroplasty is successful in the medium term for different glenohumeral diseases, irrespective of patient age at surgery. However, the appropriate treatment method for cuff tear and posttraumatic conditions of the shoulder remains to be found, particularly in young patients.
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Artroplastía de Reemplazo de Hombro/métodos , Hemiartroplastia/métodos , Adulto , Factores de Edad , Anciano , Anciano de 80 o más Años , Artritis Reumatoide/cirugía , Artroplastía de Reemplazo de Hombro/efectos adversos , Femenino , Hemiartroplastia/efectos adversos , Humanos , Masculino , Persona de Mediana Edad , Osteoartritis/etiología , Osteoartritis/cirugía , Osteonecrosis/cirugía , Satisfacción del Paciente , Estudios Prospectivos , Rango del Movimiento Articular , Recuperación de la Función , Reoperación , Lesiones del Manguito de los Rotadores/cirugía , Lesiones del Hombro/complicaciones , Articulación del Hombro/fisiopatología , Resultado del TratamientoRESUMEN
OBJECTIVES: In multiple myeloma and its precursor stages, plasma cell infiltration (PCI) and cytogenetic aberrations are important for staging, risk stratification, and response assessment. However, invasive bone marrow (BM) biopsies cannot be performed frequently and multifocally to assess the spatially heterogenous tumor tissue. Therefore, the goal of this study was to establish an automated framework to predict local BM biopsy results from magnetic resonance imaging (MRI). MATERIALS AND METHODS: This retrospective multicentric study used data from center 1 for algorithm training and internal testing, and data from center 2 to 8 for external testing. An nnU-Net was trained for automated segmentation of pelvic BM from T1-weighted whole-body MRI. Radiomics features were extracted from these segmentations, and random forest models were trained to predict PCI and the presence or absence of cytogenetic aberrations. Pearson correlation coefficient and the area under the receiver operating characteristic were used to evaluate the prediction performance for PCI and cytogenetic aberrations, respectively. RESULTS: A total of 672 MRIs from 512 patients (median age, 61 years; interquartile range, 53-67 years; 307 men) from 8 centers and 370 corresponding BM biopsies were included. The predicted PCI from the best model was significantly correlated ( P ≤ 0.01) to the actual PCI from biopsy in all internal and external test sets (internal test set: r = 0.71 [0.51, 0.83]; center 2, high-quality test set: r = 0.45 [0.12, 0.69]; center 2, other test set: r = 0.30 [0.07, 0.49]; multicenter test set: r = 0.57 [0.30, 0.76]). The areas under the receiver operating characteristic of the prediction models for the different cytogenetic aberrations ranged from 0.57 to 0.76 for the internal test set, but no model generalized well to all 3 external test sets. CONCLUSIONS: The automated image analysis framework established in this study allows for noninvasive prediction of a surrogate parameter for PCI, which is significantly correlated to the actual PCI from BM biopsy.
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Aprendizaje Profundo , Mieloma Múltiple , Masculino , Humanos , Persona de Mediana Edad , Mieloma Múltiple/diagnóstico por imagen , Mieloma Múltiple/genética , Médula Ósea/diagnóstico por imagen , Estudios Retrospectivos , Imagen por Resonancia Magnética/métodos , Biopsia , Aberraciones CromosómicasRESUMEN
BACKGROUND/OBJECTIVES: Apparent diffusion coefficient (ADC) and signal intensity (SI) measurements play an increasing role in magnetic resonance imaging (MRI) of monoclonal plasma cell disorders. The purpose of this study was to assess interrater variability, repeatability, and reproducibility of ADC and SI measurements from bone marrow (BM) under variation of MRI protocols and scanners. PATIENTS AND METHODS: Fifty-five patients with suspected or confirmed monoclonal plasma cell disorder were prospectively included in this institutional review board-approved study and underwent several measurements after the standard clinical whole-body MR scan, including repeated scan after repositioning, scan with a second MRI protocol, scan at a second 1.5 T scanner with a harmonized MRI protocol, and scan at a 3 T scanner. For T1-weighted, T2-weighted STIR, B800 images, and ADC maps, regions of interest were placed in the BM of the iliac crest and sacral bone, and in muscle tissue for image normalization. Bland-Altman plots were constructed, and absolute bias, relative bias to mean, limits of agreement, and coefficients of variation were calculated. RESULTS: Interrater variability and repeatability experiments showed a maximal relative bias of -0.077 and a maximal coefficient of variation of 16.2% for all sequences. Although the deviations at the second 1.5 T scanner with harmonized MRI protocol to the first 1.5 T scanner showed a maximal relative bias of 0.124 for all sequences, the variation of the MRI protocol and scan at the 3 T scanner led to large relative biases of up to -0.357 and -0.526, respectively. When comparing the 3 T scanner to the 1.5 T scanner, normalization to muscle reduced the bias of T1-weighted and T2-weighted sequences, but not of ADC maps. CONCLUSIONS: The MRI scanners with identical field strength and harmonized MRI protocols can provide relatively stable quantitative measurements of BM ADC and SI. Deviations in MRI field strength and MRI protocol should be avoided when applying ADC cutoff values, which were established at other scanners or when performing multicentric imaging trials.
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Médula Ósea , Células Plasmáticas , Médula Ósea/diagnóstico por imagen , Imagen de Difusión por Resonancia Magnética/métodos , Humanos , Imagen por Resonancia Magnética , Estudios Prospectivos , Reproducibilidad de los ResultadosRESUMEN
OBJECTIVES: The aim of this study was to estimate the prospective utility of a previously retrospectively validated convolutional neural network (CNN) for prostate cancer (PC) detection on prostate magnetic resonance imaging (MRI). MATERIALS AND METHODS: The biparametric (T2-weighted and diffusion-weighted) portion of clinical multiparametric prostate MRI from consecutive men included between November 2019 and September 2020 was fully automatically and individually analyzed by a CNN briefly after image acquisition (pseudoprospective design). Radiology residents performed 2 research Prostate Imaging Reporting and Data System (PI-RADS) assessments of the multiparametric dataset independent from clinical reporting (paraclinical design) before and after review of the CNN results and completed a survey. Presence of clinically significant PC was determined by the presence of an International Society of Urological Pathology grade 2 or higher PC on combined targeted and extended systematic transperineal MRI/transrectal ultrasound fusion biopsy. Sensitivities and specificities on a patient and prostate sextant basis were compared using the McNemar test and compared with the receiver operating characteristic (ROC) curve of CNN. Survey results were summarized as absolute counts and percentages. RESULTS: A total of 201 men were included. The CNN achieved an ROC area under the curve of 0.77 on a patient basis. Using PI-RADS ≥3-emulating probability threshold (c3), CNN had a patient-based sensitivity of 81.8% and specificity of 54.8%, not statistically different from the current clinical routine PI-RADS ≥4 assessment at 90.9% and 54.8%, respectively ( P = 0.30/ P = 1.0). In general, residents achieved similar sensitivity and specificity before and after CNN review. On a prostate sextant basis, clinical assessment possessed the highest ROC area under the curve of 0.82, higher than CNN (AUC = 0.76, P = 0.21) and significantly higher than resident performance before and after CNN review (AUC = 0.76 / 0.76, P ≤ 0.03). The resident survey indicated CNN to be helpful and clinically useful. CONCLUSIONS: Pseudoprospective paraclinical integration of fully automated CNN-based detection of suspicious lesions on prostate multiparametric MRI was demonstrated and showed good acceptance among residents, whereas no significant improvement in resident performance was found. General CNN performance was preserved despite an observed shift in CNN calibration, identifying the requirement for continuous quality control and recalibration.
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Aprendizaje Profundo , Neoplasias de la Próstata , Radiología , Humanos , Biopsia Guiada por Imagen/métodos , Imagen por Resonancia Magnética/métodos , Masculino , Próstata/diagnóstico por imagen , Próstata/patología , Neoplasias de la Próstata/patología , Estudios RetrospectivosRESUMEN
PURPOSE: Paclitaxel is an antiproliferative agent in drug-eluting stents with largely unknown tissue interaction. Toxicity might result from overdosage and/or accumulation. Part 1 of this two-step study investigated how paclitaxel uptake depends on dose density, coronary drug transfer kinetics, and elution efficacy. MATERIALS AND METHODS: With cobalt chromium stents and Polyzene-F nanoscale coating, low, intermediate, and high paclitaxel dose densities (25 microg, 50 microg, and 150 microg per stent) were investigated in porcine right coronary arteries (RCAs). Coronary and myocardial tissue concentration measurements and determination of on-stent paclitaxel and plasma concentrations were performed at 2, 8, 24, and 72 hours. RESULTS: For all stents, uptake was similar at all time intervals (paclitaxel RCA concentration range, 1,610-33,300 ng). Low- and intermediate-dose stents showed similar RCA concentrations, but those for high-dose stents were three times greater. Residual on-stent paclitaxel concentration was not time-dependent, at 33.3% on low-, 30.6% on intermediate-, and 17.4% on high-dose stents. Paclitaxel was measurable in only the plasma immediately after stent placement, with a linear dose relationship and a timely regression: measurements in high-dose stents were 0.0454-0.656 ng/mL at 1 minute and 0.0329-0.0879 ng/mL at 5 minutes. Untreated control samples of the left coronary artery showed a linear dose-dependent concentration (12.6 ng/g, 21.2 ng/g, and 85.2 ng/g). CONCLUSIONS: Overall coronary paclitaxel uptake is fairly independent from the baseline overall dose density and, hence, depends on immediate binding mechanisms of the arterial wall. This is supported by the fact that, regardless of the applied dose density, the kinetics of paclitaxel uptake did not follow an exposure time pattern.
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Angioplastia Coronaria con Balón/instrumentación , Fármacos Cardiovasculares/farmacocinética , Materiales Biocompatibles Revestidos , Vasos Coronarios/metabolismo , Stents Liberadores de Fármacos , Inflamación/metabolismo , Paclitaxel/farmacocinética , Angioplastia Coronaria con Balón/efectos adversos , Animales , Disponibilidad Biológica , Fármacos Cardiovasculares/administración & dosificación , Fármacos Cardiovasculares/sangre , Fármacos Cardiovasculares/toxicidad , Aleaciones de Cromo , Vasos Coronarios/efectos de los fármacos , Vasos Coronarios/patología , Relación Dosis-Respuesta a Droga , Femenino , Inflamación/inducido químicamente , Inflamación/patología , Modelos Animales , Miocardio/metabolismo , Paclitaxel/administración & dosificación , Paclitaxel/sangre , Paclitaxel/toxicidad , Polímeros , Diseño de Prótesis , Porcinos , Porcinos Enanos , Distribución TisularRESUMEN
PURPOSE: In part 1 of the present study, the authors demonstrated that coronary paclitaxel uptake from drug eluting stents (DESs) was not dependent on exposure time and dose. In this second part, the effect of the different paclitaxel dose densities on long-term biologic behavior was evaluated. MATERIALS AND METHODS: In 40 minipigs, (with 4- and 12-week follow-up), identical stents with the same three paclitaxel dose densities as in part 1 were implanted in the right coronary artery. Minipigs implanted with Polyzene-F nanocoated stents served as the control group. Quantitative angiography measuring average luminal diameter (from three in-stent reference points), minimal luminal diameter (from the point of maximum in-stent stenosis), average late loss, maximum late loss, and binary stenosis rate was performed, as was microscopy to determine neointimal thickening, injury score, and inflammation. RESULTS: All three DESs were associated with a high average late loss, binary stenosis rate, and neointimal thickening, without significant differences. Drug-free stents had significantly less late in-stent stenosis: there was an average late loss of 0.3 mm +/- 0.3 in drug-free stents versus 0.8 mm +/- 0.2 in intermediate-dose stents and 1.5 mm +/- 0.6 in high-dose stents (P = .04). DES-associated inflammation was high in all DESs and six times higher as in the drug-free stents (Kornowski scores of 0.2 +/- 0.1 in drug-free stents, 1.3 +/- 0.9 in low-dose stents, 1.7 +/- 0.8 in intermediate-dose stents, and 1.3 +/- 1.0 in high-dose stents; P = .04). It worsened with time in all DESs, as did late in-stent stenosis. CONCLUSIONS: The extensive and long-term retention of paclitaxel even in a low-dose formulation, at least according to the present labeling of DESs, might be associated with negative long-term results with regard to inflammation and late in-stent stenosis.
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Angioplastia Coronaria con Balón/instrumentación , Fármacos Cardiovasculares/toxicidad , Materiales Biocompatibles Revestidos , Reestenosis Coronaria/inducido químicamente , Vasos Coronarios/efectos de los fármacos , Stents Liberadores de Fármacos , Inflamación/inducido químicamente , Paclitaxel/toxicidad , Angioplastia Coronaria con Balón/efectos adversos , Animales , Fármacos Cardiovasculares/administración & dosificación , Angiografía Coronaria , Reestenosis Coronaria/diagnóstico por imagen , Reestenosis Coronaria/patología , Vasos Coronarios/patología , Relación Dosis-Respuesta a Droga , Femenino , Inflamación/diagnóstico por imagen , Inflamación/patología , Modelos Animales , Paclitaxel/administración & dosificación , Diseño de Prótesis , Falla de Prótesis , Porcinos , Porcinos Enanos , Factores de TiempoRESUMEN
PURPOSE: To determine the arterial distribution pattern of the embolic agent Embozene within the porcine kidney and compare it with those of other spherical embolic agents. MATERIALS AND METHODS: Embozene, Embosphere, Bead Block, and Contour SE in size classes of 100-300 microm, 500-700 microm, and 700-900 microm and Embozene and Embosphere in the size class of 40-120 microm were used for total arterial occlusion in minipig kidneys. Organs were evaluated microscopically regarding vascular distribution of the different embolic agents and particle sizes. RESULTS: The following variations of arterial distribution were identified. In the 40-120-microm size class, Embosphere particles penetrated significantly deeper compared with Embozene (P = .04). In the 100-300-microm size class, Bead Block showed a significantly deeper distribution as microscopy identified particles in arteries much smaller than their nominal size. In the 500-700-microm size class, Embosphere and Contour SE showed a deeper distribution. The most uniform arterial distribution was observed in the 700-900 microm size class,. However, few Embosphere and Contour SE particles were found in arcuate arteries, also indicating a distal distribution. CONCLUSIONS: Throughout the four most-used size classes, from very small (40-120 microm) to large (700-900 microm), the distribution characteristics of the four tested materials vary substantially. Particularly, small Embosphere particles and small Bead Block particles showed a more distal distribution, as did medium-sized Embosphere and Contour SE particles. In the largest investigated size class, the distribution was more uniform. In general, the Embozene particles are very uniform in size, and they seem to reach vessels closely corresponding to their nominal size.
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Embolización Terapéutica/métodos , Riñón/irrigación sanguínea , Polímeros/administración & dosificación , Arteria Renal , Resinas Acrílicas/administración & dosificación , Animales , Gelatina/administración & dosificación , Hidrogel de Polietilenoglicol-Dimetacrilato/administración & dosificación , Inyecciones Intraarteriales , Modelos Animales , Compuestos Organofosforados/administración & dosificación , Tamaño de la Partícula , Alcohol Polivinílico/administración & dosificación , Radiografía , Arteria Renal/anatomía & histología , Arteria Renal/diagnóstico por imagen , Porcinos , Porcinos EnanosRESUMEN
PURPOSE: To evaluate the immunohistochemical inflammatory reaction after porcine renal embolization with the new spherical embolic agent Embozene and to compare it with other spherical embolic agents. MATERIALS AND METHODS: After superselective porcine renal embolization (40 pigs) with different sizes of embolic agents (Embozene, Embosphere, Bead Block, Contour SE), tissue arrays were obtained (size ranges, 40-120 microm, 100-300 microm, 500-700 microm, 700-900 microm). After immunostaining for CD subtyping (CD45 and CD68) and cytokines (C-reactive protein [CRP] and interleukin-1 beta), a semiquantitative immunoreactivity score was calculated for each marker: intensity of staining was scored between 0 (negative) and 3 (intensive) and extent of staining between 0 and 4 (>80%), indicating the percentage of positive staining. The intensity score (0-3) was multiplied by the extent of staining score (0-4), resulting in a semiquantitative immunoreactivity score (0-12). RESULTS: Analysis of cellular expression profiles (ie, CD45, CD68) revealed a significantly higher inflammatory score 4 weeks after embolization with Embosphere 100-300 microm particles than after embolization with Embozene, Bead Block, and Contour SE. After 12 weeks, the Embosphere 100-300 microm score decreased. Analysis of CRP expression showed similar results, with a significantly higher score 4 weeks after embolization with Embosphere 100-300 microm. In the size class used most frequently for uterine artery emboliation (500-700 microm), all scores were low (<2.5) and there was no significant difference among particle types. CONCLUSIONS: Pronounced immunomarker expression was seen 4 weeks after embolization with small Embosphere particles. However, in general, modern spherical embolic agents cause a fairly low level of inflammatory reaction. In the present experimental setting, which is highly sensitive for specific tissue-to-agent reactivity, Embozene presented with low inflammatory results.
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Resinas Acrílicas/efectos adversos , Modelos Animales de Enfermedad , Gelatina/efectos adversos , Hemostáticos/efectos adversos , Nefritis/inducido químicamente , Nefritis/patología , Embolización de la Arteria Uterina/efectos adversos , Animales , Humanos , Riñón/efectos de los fármacos , Riñón/patología , Porcinos , Porcinos EnanosRESUMEN
BACKGROUND: In 2014, the diagnostic criteria for multiple myeloma were updated, leading to revised recommendations for imaging modalities and definition of therapy response. This review provides an overview of the current definitions of monoclonal plasma cell disease, diagnostic options, and changes relevant to radiologists. METHOD: A pubmed search regarding the multiple myeloma guidelines was conducted, and results were filtered considering publications of international associations and expert reviews. Recommendations by the International Myeloma Working Group (IMWG), the National Comprehensive Cancer Network (NCCN, USA), the European Society for Medical Oncology (ESMO), and the European Myeloma Network are acknowledged. RESULTS AND CONCLUSION: Conventional skeletal survey is to be replaced by cross-sectional imaging techniques. For initial diagnostics of bone lesions or bone marrow involvement defining multiple myeloma, whole-body low-dose CT and whole-body MRI are recommended. Two or more focal bone marrow lesions suspicious for myeloma on MRI will now define symptomatic disease even in the case of intact mineralized bone. Follow-up imaging is not clearly specified so far. New guidelines concerning the definitions of minimal residual disease include the assessment of focal lesions before and after treatment using 18F-FDG-PET/CT, with the potential to redefine the role of PET/CT in the diagnostics of multiple myeloma. KEY POINTS: · Whole-body low-dose CT is recommended by international reference organizations for detecting lytic bone lesions.. · Focal myeloma lesions detected on whole-body MRI will indicate symptomatic multiple myeloma requiring therapy, even in the absence of damage to mineralized bone.. · The IMWG recommends using cross-sectional imaging in the initial work-up: whole-body low-dose CT, MRI, or PET/CT, depending on availability and resources.. · The diagnostic potential of 18F-FDG-PET/CT is highlighted by its inclusion in the definition of minimal residual disease after therapy; implementation in Germany is uncertain due to limited access in the daily routine.. CITATION FORMAT: · Mosebach J, Thierjung H, Schlemmer H etâal. Multiple Myeloma Guidelines and Their Recent Updates: Implications for Imaging. Fortschr Röntgenstr 2019; 191: 998â-â1009.
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Diagnóstico por Imagen/normas , Mieloma Múltiple/diagnóstico por imagen , Guías de Práctica Clínica como Asunto , Comparación Transcultural , Europa (Continente) , Humanos , Imagen por Resonancia Magnética/normas , Mieloma Múltiple/patología , Mieloma Múltiple/terapia , Estadificación de Neoplasias/normas , Tomografía de Emisión de Positrones/normas , Pronóstico , Tomografía Computarizada por Rayos X/normas , Resultado del TratamientoRESUMEN
We sought to describe and compare material specific inflammatory and foreign body reactions after porcine liver embolization with spherical embolic agents. In 40 animals, superselective liver embolization was performed with four different spherical embolic agents of various sizes: 40-120 microm (Embozene, Embosphere), and 100-300 microm, 500-700 microm, and 700-900 microm (Embozene, Embosphere, Bead Block, and Contour SE, respectively). After 4 or 12 weeks, inflammatory reactions were evaluated microscopically according to the Banff 97 classification. For investigation of foreign body reactions, a newly designed giant cell score was applied. Banff 97 and giant cell scores closely correlated. At 4 weeks, small Embosphere particles (100-300 microm) had a significantly higher Banff 97 score than Embozene, Bead Block, and Contour SE of the corresponding size. After 12 weeks, the calculated differences were not statistically significant. Comparison between the 4-week results and the 12-week results revealed a statistically higher Banff 97 score for Embosphere 100-300 microm after 4 weeks than after 12 weeks (P = 0.02). The overall foreign body reaction was pronounced after embolization with smaller particles, especially in small Embosphere particles. Giant cell numbers with Embosphere 100-300 microm were statistically higher compared with the other materials of corresponding size (P < 0.0001). Inflammatory and giant cell reactions after embolization procedures depend on the embolic material. The overall inflammatory reaction was low. However, marked inflammation was associated with small Embosphere particles at 4 weeks, a finding that might be caused by the allogeneic overcoat. Correspondingly, giant cells indicating a foreign body reaction were more frequently associated with small particle sizes, especially after embolization with small Embosphere particles.
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Resinas Acrílicas , Embolización Terapéutica/instrumentación , Reacción a Cuerpo Extraño/inducido químicamente , Gelatina , Hígado , Animales , Inflamación , Modelos Animales , Tamaño de la Partícula , Estadísticas no Paramétricas , PorcinosRESUMEN
PURPOSE: To date no direct experimental comparison between the CYPHER-Select and TAXUS-Express stents is available. Therefore, we investigated late in-stent stenosis, thrombogenicity, and inflammation, comparing the CYPHER-Select, TAXUS-Express, and custom-made cobalt chromium Polyzene-F nanocoated stents (CCPS) in the minipig coronary artery model. METHODS: The three stent types were implanted in the right coronary artery of 30 minipigs. The primary endpoint was in-stent stenosis assessed by quantitative angiography and microscopy. Secondary endpoints were inflammation and thrombogenicity evaluated by scores for inflammation and immunoreactivity (C-reactive protein and transforming growth factor beta). Follow-up was at 4 and 12 weeks. RESULTS: Stent placement was successful in all animals; no thrombus deposition occurred. Quantitative angiography did not depict statistically significant differences between the three stent types after 4 and 12 weeks. Quantitative microscopy at 4 weeks showed a statistically significant thicker neointima (p = 0.0431) for the CYPHER (105.034 +/- 62.52 microm) versus the TAXUS (74.864 +/- 66.03 microm) and versus the CCPS (63.542 +/- 39.57 microm). At 12 weeks there were no statistically significant differences. Inflammation scores at 4 weeks were significantly lower for the CCPS and CYPHER compared with the TAXUS stent (p = 0.0431). After 12 weeks statistical significance was only found for the CYPHER versus the TAXUS stent (p = 0.0431). The semiquantitative immunoreactivity scores for C-reactive protein and transforming growth factor beta showed no statistically significant differences between the three stent types after 4 and 12 weeks. CONCLUSIONS: The CCPS provided effective control of late in-stent stenosis and thrombogenicity in this porcine model compared with the two drug-eluting stents. Its low inflammation score underscores its noninflammatory potential and might explain its equivalence to the two DES.
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Enfermedad Coronaria/terapia , Reestenosis Coronaria/patología , Stents Liberadores de Fármacos , Polímeros , Falla de Prótesis , Angioplastia Coronaria con Balón/instrumentación , Angioplastia Coronaria con Balón/métodos , Animales , Biopsia con Aguja , Prótesis Vascular , Cromo/farmacología , Materiales Biocompatibles Revestidos , Cobalto/farmacología , Enfermedad Coronaria/patología , Modelos Animales de Enfermedad , Femenino , Inmunohistoquímica , Nanocompuestos , Probabilidad , Diseño de Prótesis , Distribución Aleatoria , Sensibilidad y Especificidad , Sirolimus/uso terapéutico , Porcinos , Porcinos Enanos , TacrolimusRESUMEN
The purpose of this study was to investigate the potential of nanoscale coating with the highly biocompatible polymer Polyzene-F (PZF), in combination with cobalt chromium and stainless steel stents, to reduce in-stent stenosis, thrombogenicity, and vessel wall injury and inflammation. One bare cobalt chromium, PZF-nanocoated stainless steel or PZF-nanocoated cobalt chromium stent was implanted in right coronary artery of 30 mini-pigs (4- or 12-week follow-up). Primary study end points were in-stent stenosis and thrombogenicity. Secondary study end points were vessel wall injury and inflammation as evaluated by microscopy and a new immunoreactivity score applying C-reactive protein (CRP), tumor-necrosis factor alpha (TNFalpha), and TGFbeta. At 12 weeks, angiography showed a significantly lower average loss in lumen diameter (2.1% +/- 3.05%) in PZF-nanocoated cobalt chromium stents compared with stents in the other groups (9.73% +/- 4.93% for bare cobalt chromium stents and 9.71% +/- 7% for PZF-nanocoated stainless steel stents; p = 0.04), which was confirmed at microscopy (neointima 40.7 +/- 16 lm in PZF-nanocoated cobalt chromium stents, 74.7 +/- 57.6 lm in bare cobalt chromium stents, and 141.5 +/- 109 lm in PZF-nanocoated stainless steel stents; p = 0.04). Injury and inflammation scores were low in all stents and were without significant differences. PZF-nanocoated cobalt chromium stents provided the highest efficacy in reducing in-stent stenosis at long-term follow-up. The PZF nanocoat proved to be biocompatible with respect to thromboresistance and inflammation. Our data suggest that its combination with cobalt chromium stents might provide an interesting passive stent platform.
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Reestenosis Coronaria/prevención & control , Stents , Animales , Proteína C-Reactiva/metabolismo , Cromo , Materiales Biocompatibles Revestidos , Cobalto , Angiografía Coronaria , Femenino , Linfotoxina-alfa/metabolismo , Compuestos Organofosforados , Polímeros , Estadísticas no Paramétricas , Porcinos , Porcinos Enanos , Factor de Necrosis Tumoral alfa/metabolismoRESUMEN
PURPOSE: To evaluate the pattern of recanalization and specific inflammatory reaction after superselective embolization with four commercially available spherical embolic agents of different sizes in the mini pig kidney model. MATERIALS AND METHODS: In 40 mini pigs, the lower poles of both kidneys were superselectively embolized with Embozene, Embosphere, Bead Block, and Contour SE particles in sizes of 40-120 mircom (Embozene, Embosphere) and 100-300 microm, 500-700 microm, and 700-900 microm (Embozene, Embosphere, Bead Block, Contour SE). After a follow-up time of 4 or 12 weeks, recanalization was determined with angiography. Pathologic and histologic evaluation of the kidneys was performed, and the Banff 97 classification was used to evaluate the extent of vessel wall inflammation. Macroscopically visible ischemic changes were evaluated by using a specific ischemia score. RESULTS: After embolization with Embozene microspheres, larger Embosphere particles, and Bead Block and Contour SE particles, the absence of inflammation or a low inflammation score was observed. Significantly elevated inflammation scores were evident with small Embosphere particles after 4 weeks (mean score, 1.21 +/- 1.0). Distinct recanalization occurred with Contour SE particles (100% recanalization with 100-300-microm particles at 12 weeks, 500-700-microm particles at 4 and 12 weeks, and 700-900-microm particles at 4 weeks). Ischemia scores were highest in the target area in all specimens. Mildly elevated ischemia scores in nontarget tissue areas were indicative of minor nontarget embolization. CONCLUSIONS: Except for small Embosphere particles at 4 weeks, the absence of inflammatory reaction to the embolization procedure or only low inflammatory changes were observed with all embolic agents, particle sizes, and follow-up intervals. Recanalization was evident with all embolic agents; however, it was pronounced with Contour SE particles.
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Embolización Terapéutica , Resinas Acrílicas , Angiografía , Animales , Gelatina , Hidrogeles , Inflamación , Modelos Animales , Tamaño de la Partícula , Fotomicrografía , Polimetil Metacrilato , Alcohol Polivinílico , Estadísticas no Paramétricas , Porcinos , Porcinos EnanosRESUMEN
The objective of this study was to evaluate inflammatory response and recanalization after embolization with a new spherical embolic agent based on a core and shell design with a hydrogel core of polymethylmethacrylate (PMMA) and a Polyzene-F nanoscale coating in a porcine kidney model. Thirty-six minipigs were enrolled for superselective renal embolization. Polyzene-F-coated PMMA particles and uncoated PMMA particles with a diameter of 300-600 mum were used. Either 4 or 12 weeks post-embolization, arteriography of the embolized kidneys was performed and then compared with pre- and immediate post-embolization arteriograms using a specific recanalization score to determine the extent of recanalization. Using a microscopic inflammation score (Banff classification), the embolized organs were examined for local inflammatory effects which occurred in response to the embolic agent. In Polyzene-F-coated particles, the Banff classification showed an average inflammation score of 0.26 +/- 0.58 at 4 weeks and of 0.08 +/- 0.28 at 12 weeks. In uncoated particles, the Banff score measured 0.37 +/- 0.6 at 4 weeks, which was higher, but without a statistically significant difference. According to the recanalization score used in this study, mild angiographic recanalization was evident in all groups, without statistically significant differences (3.0 +/- 0.71 in coated particles, 3.09 +/- 0.81 in uncoated particles; p = 0.74). We conclude that both uncoated hydrogel particles and Polyzene-F-coated embolic agents triggered virtually no inflammatory response and effectively occluded target arteries. This study demonstrates good biocompatibility of the new embolic material. As in other spherical embolic agents, recanalization can occur to some degree.