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1.
N Engl J Med ; 389(15): 1368-1379, 2023 Oct 12.
Artículo en Inglés | MEDLINE | ID: mdl-37634190

RESUMEN

BACKGROUND: In patients with ST-segment elevation myocardial infarction (STEMI) with multivessel coronary artery disease, the time at which complete revascularization of nonculprit lesions should be performed remains unknown. METHODS: We performed an international, open-label, randomized, noninferiority trial at 37 sites in Europe. Patients in a hemodynamically stable condition who had STEMI and multivessel coronary artery disease were randomly assigned to undergo immediate multivessel percutaneous coronary intervention (PCI; immediate group) or PCI of the culprit lesion followed by staged multivessel PCI of nonculprit lesions within 19 to 45 days after the index procedure (staged group). The primary end point was a composite of death from any cause, nonfatal myocardial infarction, stroke, unplanned ischemia-driven revascularization, or hospitalization for heart failure at 1 year after randomization. The percentages of patients with a primary or secondary end-point event are provided as Kaplan-Meier estimates at 6 months and at 1 year. RESULTS: We assigned 418 patients to undergo immediate multivessel PCI and 422 to undergo staged multivessel PCI. A primary end-point event occurred in 35 patients (8.5%) in the immediate group as compared with 68 patients (16.3%) in the staged group (risk ratio, 0.52; 95% confidence interval, 0.38 to 0.72; P<0.001 for noninferiority and P<0.001 for superiority). Nonfatal myocardial infarction and unplanned ischemia-driven revascularization occurred in 8 patients (2.0%) and 17 patients (4.1%), respectively, in the immediate group and in 22 patients (5.3%) and 39 patients (9.3%), respectively, in the staged group. The risk of death from any cause, the risk of stroke, and the risk of hospitalization for heart failure appeared to be similar in the two groups. A total of 104 patients in the immediate group and 145 patients in the staged group had a serious adverse event. CONCLUSIONS: Among patients in hemodynamically stable condition with STEMI and multivessel coronary artery disease, immediate multivessel PCI was noninferior to staged multivessel PCI with respect to the risk of death from any cause, nonfatal myocardial infarction, stroke, unplanned ischemia-driven revascularization, or hospitalization for heart failure at 1 year. (Supported by Boston Scientific; MULTISTARS AMI ClinicalTrials.gov number, NCT03135275.).


Asunto(s)
Enfermedad de la Arteria Coronaria , Intervención Coronaria Percutánea , Infarto del Miocardio con Elevación del ST , Humanos , Enfermedad de la Arteria Coronaria/complicaciones , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Enfermedad de la Arteria Coronaria/cirugía , Vasos Coronarios/cirugía , Europa (Continente) , Insuficiencia Cardíaca/etiología , Infarto del Miocardio/etiología , Infarto del Miocardio/cirugía , Revascularización Miocárdica/efectos adversos , Revascularización Miocárdica/métodos , Intervención Coronaria Percutánea/efectos adversos , Intervención Coronaria Percutánea/métodos , Intervención Coronaria Percutánea/mortalidad , Infarto del Miocardio con Elevación del ST/etiología , Infarto del Miocardio con Elevación del ST/mortalidad , Infarto del Miocardio con Elevación del ST/cirugía , Accidente Cerebrovascular/etiología , Factores de Tiempo , Resultado del Tratamiento , Tiempo de Tratamiento
2.
Circulation ; 147(7): 575-585, 2023 02 14.
Artículo en Inglés | MEDLINE | ID: mdl-36780380

RESUMEN

BACKGROUND: Although some studies have investigated sex-related outcomes up to 5 years after percutaneous coronary intervention (PCI), analyses at longer follow-up (ie, to 10 years) in large cohorts treated exclusively with drug-eluting stent (DES) platforms are lacking. Therefore, this study aimed to define whether sex-related differences in long-term outcomes after PCI persist both in the DES era and at longer-term follow-up. METHODS: Individual data of patients treated with DES in 5 randomized controlled trials with 10-year follow-up were pooled. Patients were divided into 2 groups by sex. The analysis of individual participant data was performed using a 1-stage approach by entering a clustering effect by parent study in all univariable and multivariable models focusing on sex. The main outcomes of interest for this analysis included cardiovascular death, myocardial infarction, repeat revascularization, and definite stent thrombosis to 10 years after PCI. Survival was analyzed by the Kaplan-Meier method to estimate the time to first event, and differences between the 2 groups were tested with the log-rank test. Hazard ratios (HRs) and 95% CIs were calculated with a Cox proportional hazards model. Conventional multivariable analyses with adjustment for relevant variables were performed. RESULTS: Among 9700 patients undergoing PCI with DES implantation included in the present analysis, 2296 were women and 7404 were men. Through to 10 years, cardiovascular death occurred in 407 of the 2296 female patients and 1012 of the 7404 male patients (adjusted HR [HRadj], 0.94 [95% CI, 0.80-1.11]). Female sex was associated with a lower risk of repeat revascularization of the target lesion (HRadj, 0.80 [95% CI, 0.74-0.87]), target vessel (HRadj, 0.81 [95% CI, 0.76-0.87]), and nontarget vessels (HRadj, 0.69 [95% CI, 0.62-0.77]). Compared with male patients, female patients displayed an increased risk of myocardial infarction in the first 30 days after PCI with DES (HRadj, 1.65 [95% CI, 1.24-2.19]) but a comparable risk of myocardial infarction thereafter. The risk of definite stent thrombosis was not significantly different between female and male patients (HRadj, 1.14 [95% CI, 0.89-1.47]). CONCLUSIONS: Through to 10-year follow-up after PCI with DES, female patients are at increased risk of early myocardial infarction, receive fewer repeat revascularizations, and have no difference in cardiovascular mortality compared with male patients.


Asunto(s)
Stents Liberadores de Fármacos , Infarto del Miocardio , Intervención Coronaria Percutánea , Trombosis , Femenino , Humanos , Masculino , Stents Liberadores de Fármacos/efectos adversos , Estimación de Kaplan-Meier , Infarto del Miocardio/complicaciones , Intervención Coronaria Percutánea/efectos adversos , Diseño de Prótesis , Factores de Riesgo , Caracteres Sexuales , Stents/efectos adversos , Trombosis/etiología , Resultado del Tratamiento
3.
Eur J Clin Invest ; 54(6): e14173, 2024 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-38264959

RESUMEN

BACKGROUND: The association of aspirin loading with the risk of coronary no-reflow (CNR) after percutaneous coronary intervention (PCI) in patients with acute myocardial infarction (AMI) has not been investigated. We assessed the association of aspirin loading before PCI with CNR in patients with AMI. MATERIALS AND METHODS: This study included 3100 patients with AMI undergoing PCI. Of them, 2812 patients received aspirin loading (a single oral [or chewed] or intravenous dose of 150-300 mg) and 288 patients did not receive aspirin loading before PCI. The primary endpoint was CNR, defined as Thrombolysis in Myocardial Infarction blood flow grade of <3 after the PCI. RESULTS: CNR occurred in 130 patients: 127 patients in the group with aspirin loading and 3 patients in the group without aspirin loading before PCI (4.5% vs. 1.0%; odds ratio [OR] = 4.50, 95% confidence interval, [1.42-14.21], p = 0.005). After adjustment, the association between aspirin loading and CNR was significant (adjusted OR = 4.49 [1.56-12.92]; p < 0.001). There was no aspirin loading-by-P2Y12 inhibitor (ticagrelor or prasugrel) interaction (pint = 0.465) or aspirin loading-by-chronic aspirin therapy on admission (pint = 0.977) interaction with respect to the occurrence of CNR after PCI. Chronic low-dose aspirin therapy on admission was not independently associated with higher risk of CNR after PCI (adjusted OR = 1.06 [0.65-1.72]; p = 0.824). CONCLUSION: In patients with AMI undergoing PCI, aspirin loading before the PCI procedure at the guideline-recommended doses was associated with higher odds of developing CNR. However, due to the limited number of events, the findings should be considered as hypothesis generating.


Asunto(s)
Aspirina , Infarto del Miocardio , Fenómeno de no Reflujo , Intervención Coronaria Percutánea , Inhibidores de Agregación Plaquetaria , Humanos , Aspirina/uso terapéutico , Masculino , Femenino , Persona de Mediana Edad , Anciano , Inhibidores de Agregación Plaquetaria/uso terapéutico , Infarto del Miocardio con Elevación del ST/terapia , Administración Oral , Antagonistas del Receptor Purinérgico P2Y/uso terapéutico
4.
Strahlenther Onkol ; 200(7): 583-594, 2024 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-38381142

RESUMEN

BACKGROUND AND OBJECTIVE: Data on enteral tube feeding in head and neck cancer (HNC) patients undergoing chemoradiotherapy vary considerably between German institutions. This survey aims to investigate the management of feeding tubes in an interdisciplinary context across Germany. MATERIALS AND METHODS: Between December 2022 and May 2023, 70 participants (42 radiation oncologists, 12 medical oncologists, 14 head and neck surgeons, and 2 physicians covering several specialties) responded to our web-based survey. In addition to the type of institution (university hospital, private practice, etc.), their age, and professional experience (in years), participants were asked several questions on the indication and institutional policy for tube placement and management (prophylactic/reactive nasogastric or gastrostomy tube). All questions were mandatory single- or multiple-choice questions, while additional comments were possible by email. RESULTS: Most participants were employed at a university hospital (n = 52; 74.3%) and came from a radiation oncology background (n = 42; 60%). Fifty-four contributors (77.1%) reported that no nutritional risk screening prior to chemoradiotherapy was routinely performed, and 71.4% (n = 50) stated that no standardized protocol was used at the institution to set the indication for tube placement. Generally, policies and methods of tube feeding vary considerably between the individual institutions and specialties. However, the majority (n = 56, 80%) recommended a prophylactic percutaneous enteral gastrostomy (PEG) tube to their patients before chemoradiotherapy. Still, there was no consistent trend regarding the approach for reactive tube feeding. CONCLUSION: The policies and methods of tube feeding vary considerably between the individual institutions and specialties in Germany. In the era of individualized medicine, uniform protocols are difficult to establish. However, a baseline nutritional risk screening could simplify decision-making in clinical practice.


Asunto(s)
Quimioradioterapia , Nutrición Enteral , Gastrostomía , Neoplasias de Cabeza y Cuello , Intubación Gastrointestinal , Humanos , Alemania , Neoplasias de Cabeza y Cuello/terapia , Masculino , Encuestas y Cuestionarios , Pautas de la Práctica en Medicina/estadística & datos numéricos , Femenino , Encuestas de Atención de la Salud , Comunicación Interdisciplinaria , Persona de Mediana Edad , Oncólogos de Radiación
5.
BMC Cancer ; 24(1): 459, 2024 Apr 12.
Artículo en Inglés | MEDLINE | ID: mdl-38609887

RESUMEN

BACKGROUND: Head and neck squamous cell carcinoma (HNSCC) represents a common and heterogeneous malignancy of the oral cavity, pharynx and larynx. Surgery and radio(chemo)therapy are the standard treatment options and also have great influence on the composition of the tumor microenvironment and immune cell functions. However, the impact of radio(chemo)therapy on the distribution and characteristics of circulating monocyte subsets in HNSCC are not fully understood. METHODS: Expression patterns of adhesion molecules and chemokine receptors CD11a (integrin-α L; LFA-1), CD11b (integrin-α M; Mac-1), CD11c (integrin-α X), CX3CR1 (CX3CL1 receptor) and checkpoint molecule PD-L1 (programmed cell death ligand-1) were investigated upon radio(chemo)therapeutic treatment using flow cytometry. Furthermore, comprehensive analysis of plasma cytokines was performed before and after treatment using ELISA measurements. RESULTS: Our data reveal a partial recovery of circulating monocytes in HNSCC patients upon radio(chemo)therapeutic treatment, with differential effects of the individual therapy regimen. PD-L1 expression on non-classical monocytes significantly correlates with the individual plasma levels of chemokine CXCL11 (C-X-C motif chemokine 11). CONCLUSIONS: Further comprehensive investigations on larger patient cohorts are required to elucidate the meaningfulness of peripheral blood monocyte subsets and chemokine CXCL11 as potential bioliquid indicators in HNSCC with regard to therapy response and the individual immunological situation.


Asunto(s)
Neoplasias de Cabeza y Cuello , Monocitos , Humanos , Antígeno B7-H1 , Carcinoma de Células Escamosas de Cabeza y Cuello/terapia , Quimiocina CXCL11 , Neoplasias de Cabeza y Cuello/terapia , Microambiente Tumoral
6.
J Sleep Res ; : e14178, 2024 Feb 22.
Artículo en Inglés | MEDLINE | ID: mdl-38385644

RESUMEN

Oxidative stress in patients suffering from obstructive sleep apnea syndrome (OSAS) is associated with a low-grade systemic inflammation, immune disturbance, and increased invasion of monocytes into the endothelium. Besides continuous positive airway pressure (PAP), hypoglossal nerve stimulation (HNS) has become a promising treatment option for patients with OSAS. We aimed to analyse the influence of HNS therapy on the cellular characteristics relevant for adhesion and immune regulation of circulating CD14/CD16 monocyte subsets. Whole blood flow cytometric measurements were performed to analyse the expression levels of different adhesion molecules and checkpoint molecule PD-L1 (programmed death-ligand 1) in connection with pro-inflammatory plasma cytokine IL-8 and the clinical values of BMI (body mass index), AHI (apnea-hypopnea index), ODI (oxygen desaturation index), and ESS (Epworth sleepiness scale) upon HNS treatment. Hypoglossal nerve stimulation treatment significantly improved the expression of adhesion molecule CD162 (P-selectin receptor) on non-classical monocytes and significantly downregulated the expression of PD-L1 on all three monocyte subsets. We conclude that the holistic improvement of different parameters such as the oxygenation of the peripheral blood, a reduced systemic inflammation, and the individual sleeping situation upon HNS respiratory support, leads to an improved immunologic situation.

7.
Arterioscler Thromb Vasc Biol ; 43(2): e83-e93, 2023 02.
Artículo en Inglés | MEDLINE | ID: mdl-36546322

RESUMEN

BACKGROUND: Immature or reticulated platelets are associated with impaired efficacy of antiplatelet drugs and adverse events in cardiovascular patients. Their role as a predictive biomarker in patients with acute coronary syndrome treated with potent P2Y12 receptor inhibitors is not fully understood. We aimed to prospectively evaluate reticulated platelets as a predictor of the primary end point of the ISAR-REACT 5 trial consisting of death, myocardial infarction, or stroke at 1 year in patients with acute coronary syndrome randomized to prasugrel or ticagrelor. METHODS: Immature platelet fraction (IPF) was assessed within 48 hours after randomization. Patients were divided based on the IPF median values: the IPFhigh group included patients with IPF>median and the IPFlow group included patients with IPF≤median. Platelet aggregation was assessed using the Multiplate Analyzer and was correlated to IPF. RESULTS: Five hundred seventy-seven patients were included in the study. IPF values in % (median [interquartile range]) within the first 48 hours did not differ between the two study groups: 3.6 (2.5-5.2)% in the prasugrel group and 3.6 (2.5-5.4)% in the ticagrelor group (P=0.882). The incidence of the primary end point was significantly higher in the IPFhigh (IPF>3.6%) group compared with the IPFlow (IPF≤3.6%) group: 13.0% versus 7.2% (HRadj, 1.74 [1.02-3.00]; P=0.044), independently from the assigned drug (Pint=0.159). No significant association between IPF and BARC 3 to 5 bleeding was observed. ADP-induced platelet aggregation correlated significantly with IPF in patients treated with prasugrel (r=0.22; P=0.005) while no correlation was detected in patients treated with ticagrelor (r=0.09; P=0.257). CONCLUSIONS: Independently from drug treatment, IPF was associated with the primary end point and therefore is a promising biomarker for the prediction of adverse cardiovascular events in patients with acute coronary syndrome treated with prasugrel or ticagrelor. REGISTRATION: https://www. CLINICALTRIALS: gov; Unique identifier: NCT01944800.


Asunto(s)
Síndrome Coronario Agudo , Intervención Coronaria Percutánea , Humanos , Ticagrelor/efectos adversos , Clorhidrato de Prasugrel/efectos adversos , Síndrome Coronario Agudo/diagnóstico , Síndrome Coronario Agudo/tratamiento farmacológico , Inhibidores de Agregación Plaquetaria/efectos adversos , Plaquetas , Resultado del Tratamiento
8.
Mol Ther ; 31(3): 866-874, 2023 03 01.
Artículo en Inglés | MEDLINE | ID: mdl-36528793

RESUMEN

Vascular endothelial growth factor A (VEGF-A) has therapeutic cardiovascular effects, but delivery challenges have impeded clinical development. We report the first clinical study of naked mRNA encoding VEGF-A (AZD8601) injected into the human heart. EPICCURE (ClinicalTrials.gov: NCT03370887) was a randomized, double-blind study of AZD8601 in patients with left ventricular ejection fraction (LVEF) 30%-50% who were undergoing elective coronary artery bypass surgery. Thirty epicardial injections of AZD8601 (total 3 mg) or placebo in citrate-buffered saline were targeted to ischemic but viable myocardial regions mapped using quantitative [15O]-water positron emission tomography. Seven patients received AZD8601 and four received placebo and were followed for 6 months. There were no deaths or treatment-related serious adverse events and no AZD8601-associated infections, immune reactions, or arrhythmias. Exploratory outcomes indicated potential improvement in LVEF, Kansas City Cardiomyopathy Questionnaire scores, and N-terminal pro-B-type natriuretic peptide levels, but the study is limited in size, and significant efficacy conclusions are not possible from the dataset. Naked mRNA without lipid encapsulation may provide a safe delivery platform for introducing genetic material to cardiac muscle, but further studies are needed to confirm efficacy and safety in a larger patient pool.


Asunto(s)
Isquemia Miocárdica , Factor A de Crecimiento Endotelial Vascular , Humanos , Factor A de Crecimiento Endotelial Vascular/genética , Volumen Sistólico , Función Ventricular Izquierda , Puente de Arteria Coronaria/efectos adversos , Puente de Arteria Coronaria/métodos , Corazón , Resultado del Tratamiento , Isquemia Miocárdica/terapia
9.
Platelets ; 35(1): 2358244, 2024 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-38845541

RESUMEN

Thromboembolic events are common in patients with essential thrombocythemia (ET). However, the pathophysiological mechanisms underlying the increased thrombotic risk remain to be determined. Here, we perform the first phenotypical characterization of platelet expression using single-cell mass cytometry in six ET patients and six age- and sex-matched healthy individuals. A large panel of 18 transmembrane regulators of platelet function and activation were analyzed, at baseline and after ex-vivo stimulation with thrombin receptor-activating peptide (TRAP). We detected a significant overexpression of the activation marker CD62P (p-Selectin) (p = .049) and the collagen receptor GPVI (p = .044) in non-stimulated ET platelets. In contrast, ET platelets had a lower expression of the integrin subunits of the fibrinogen receptor GPIIb/IIIa CD41 (p = .036) and CD61 (p = .044) and of the von Willebrand factor receptor CD42b (p = .044). Using the FlowSOM algorithm, we identified 2 subclusters of ET platelets with a prothrombotic expression profile, one of them (cluster 3) significantly overrepresented in ET (22.13% of the total platelets in ET, 2.94% in controls, p = .035). Platelet counts were significantly increased in ET compared to controls (p = .0123). In ET, MPV inversely correlated with platelet count (r=-0.96). These data highlight the prothrombotic phenotype of ET and postulate GPVI as a potential target to prevent thrombosis in these patients.


Essential thrombocythemia (ET) is a rare disease characterized by an increased number of platelets in the blood. As a complication, many of these patients develop a blood clot, which can be life-threatening. So far, the reason behind the higher risk of blood clots is unclear. In this study, we analyzed platelet surface markers that play a critical role in platelet function and platelet activation using a modern technology called mass cytometry. For this purpose, blood samples from 6 patients with ET and 6 healthy control individuals were analyzed. We found significant differences between ET platelets and healthy platelets. ET platelets had higher expression levels of p-Selectin (CD62P), a key marker of platelet activation, and of the collagen receptor GPVI, which is important for clot formation. These results may be driven by a specific platelet subcluster overrepresented in ET. Other surface markers, such as the fibrinogen receptor GPIIb/IIIa CD41, CD61, and the von Willebrand factor receptor CD42b, were lower expressed in ET platelets. When ET platelets were treated with the clotting factor thrombin (thrombin receptor-activating peptide, TRAP), we found a differential response in platelet activation compared to healthy platelets. In conclusion, our results show an increased activation and clotting potential of ET platelets. The platelet surface protein GPVI may be a potential drug target to prevent abnormal blood clotting in ET patients.


Asunto(s)
Plaquetas , Trombocitemia Esencial , Trombosis , Humanos , Trombocitemia Esencial/metabolismo , Trombocitemia Esencial/complicaciones , Plaquetas/metabolismo , Masculino , Femenino , Trombosis/metabolismo , Trombosis/etiología , Persona de Mediana Edad , Anciano , Citometría de Flujo/métodos , Activación Plaquetaria , Estudios de Casos y Controles , Adulto
10.
BMC Med Imaging ; 24(1): 43, 2024 Feb 13.
Artículo en Inglés | MEDLINE | ID: mdl-38350900

RESUMEN

BACKGROUND: A deep learning (DL) model that automatically detects cardiac pathologies on cardiac MRI may help streamline the diagnostic workflow. To develop a DL model to detect cardiac pathologies on cardiac MRI T1-mapping and late gadolinium phase sensitive inversion recovery (PSIR) sequences were used. METHODS: Subjects in this study were either diagnosed with cardiac pathology (n = 137) including acute and chronic myocardial infarction, myocarditis, dilated cardiomyopathy, and hypertrophic cardiomyopathy or classified as normal (n = 63). Cardiac MR imaging included T1-mapping and PSIR sequences. Subjects were split 65/15/20% for training, validation, and hold-out testing. The DL models were based on an ImageNet pretrained DenseNet-161 and implemented using PyTorch and fastai. Data augmentation with random rotation and mixup was applied. Categorical cross entropy was used as the loss function with a cyclic learning rate (1e-3). DL models for both sequences were developed separately using similar training parameters. The final model was chosen based on its performance on the validation set. Gradient-weighted class activation maps (Grad-CAMs) visualized the decision-making process of the DL model. RESULTS: The DL model achieved a sensitivity, specificity, and accuracy of 100%, 38%, and 88% on PSIR images and 78%, 54%, and 70% on T1-mapping images. Grad-CAMs demonstrated that the DL model focused its attention on myocardium and cardiac pathology when evaluating MR images. CONCLUSIONS: The developed DL models were able to reliably detect cardiac pathologies on cardiac MR images. The diagnostic performance of T1 mapping alone is particularly of note since it does not require a contrast agent and can be acquired quickly.


Asunto(s)
Aprendizaje Profundo , Gadolinio , Humanos , Imagen por Resonancia Magnética/métodos , Miocardio/patología , Medios de Contraste , Pericardio
11.
Eur Heart J ; 44(15): 1343-1357, 2023 04 17.
Artículo en Inglés | MEDLINE | ID: mdl-36807512

RESUMEN

AIMS: The best interventional strategy for the treatment of drug-eluting stent (DES) in-stent restenosis (ISR) is still unclear and no data from randomized trials beyond 3-year follow-up are available. We aimed to define 10-year comparative efficacy and safety of plain balloon (PB), paclitaxel-coated balloon (PCB), and paclitaxel-eluting stent (PES) for percutaneous coronary intervention (PCI) of DES-ISR. METHODS AND RESULTS: Clinical follow-up of patients randomly assigned to PB, PCB, and PES in the ISAR-DESIRE 3 trial was extended to 10 years and events were independently adjudicated. The primary endpoint was a composite of cardiac death, target vessel myocardial infarction, target lesion thrombosis, or target lesion revascularization. The major secondary safety endpoint was a composite of cardiac death, target vessel myocardial infarction, or target lesion thrombosis. The major secondary efficacy endpoint was target lesion revascularization. Incidences by the Kaplan-Meier method were compared by the log-rank test. Risk estimation was primarily performed by Cox proportional hazards regression and supplemented by weighted Cox regression accounting for non-proportional hazards and Royston-Parmar flexible parametric regression with a time-varying coefficient. Primary results were further assessed by landmark, lesion-level, per-protocol, and competing risk analyses. A total of 402 patients (500 lesions) with DES-ISR were randomly assigned to PB angioplasty (134 patients, 160 lesions), PCB angioplasty (137 patients, 172 lesions), and PES implantation (131 patients, 168 lesions). Clinical follow-up did not significantly differ among treatments [PB, 9.62 (4.50-10.02) years; PCB, 10.01 (5.72-10.02) years; PES, 9.08 (3.14-10.02) years; P = 0.300]. At 10 years, the primary composite endpoint occurred in 90 patients (72.0%) assigned to PB, 70 patients (55.9%) assigned to PCB, and 72 patients (62.4%) assigned to PES (P < 0.001). The pairwise comparison between PCB and PES resulted in a non-significant difference [multiplicity-adjusted P = 0.610; Grambsch-Therneau P = 0.004; weighted Cox: hazard ratio (HR) 1.10, 95% confidence interval (CI) 0.80-1.51; Cox: HR 1.10, 95% CI 0.79-1.52; Royston-Parmar: HR 1.08, 95% CI 0.72-1.60]. The major secondary safety endpoint occurred in 39 patients (34.1%) assigned to PB, 39 patients (34.0%) assigned to PCB, and 42 patients (40.0%) assigned to PES (P = 0.564). Target lesion revascularization occurred in 71 patients (58.0%) assigned to PB, 55 patients (43.9%) assigned to PCB, and 42 patients (38.6%) assigned to PES (P < 0.0001). The pairwise comparison between PES and PCB resulted in a non-significant difference (multiplicity-adjusted P = 0.282; Grambsch-Therneau P = 0.002; weighted Cox: HR 0.83, 95% CI 0.56-1.22; Cox: HR 0.81, 95% CI 0.54-1.21; Royston-Parmar: HR 0.75, 95% CI 0.47-1.20). Lesion-level and per-protocol analyses were consistent. At landmark analyses, an excess of death and cardiac death associated with PES compared with PCB was observed within 5 years after PCI, though 10-year differences did not formally reach the threshold of statistical significance after adjustment for multiplicity. Competing risk regression confirmed a non-significant difference in target lesion revascularization between PCB and PES and showed an increased risk of death associated with PES compared with PCB. CONCLUSION: Ten years after PCI for DES-ISR, the primary and major secondary endpoints between PCB and PES were not significantly different. However, an excess of death and cardiac death within 5 years associated with PES and the results of the competing risk analysis are challenging to interpret and warrant further analysis. PES and PCB significantly reduced target lesion revascularization compared with PB.


Asunto(s)
Reestenosis Coronaria , Stents Liberadores de Fármacos , Infarto del Miocardio , Intervención Coronaria Percutánea , Humanos , Reestenosis Coronaria/etiología , Intervención Coronaria Percutánea/efectos adversos , Stents Liberadores de Fármacos/efectos adversos , Vasos Coronarios , Resultado del Tratamiento , Infarto del Miocardio/etiología , Paclitaxel/efectos adversos , Angiografía Coronaria/efectos adversos
12.
Catheter Cardiovasc Interv ; 102(4): 646-654, 2023 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-37605515

RESUMEN

BACKGROUND: Only few data is available for long-term outcomes of patients being treated for in-stent restenosis (ISR) in saphenous vein grafts (SVG). AIMS: Thus, the aim of this observational, retrospective study was to close this lack of evidence. METHODS: Between January 2007 and February 2021 a total of 163 patients with 186 ISR lesions located in SVG were treated at two large-volume centers in Munich, Germany. Endpoints of interest were all-cause mortality, target lesion revascularization (TLR) and target vessel myocardial infarction (TVMI). Furthermore, recurrent ISR were assessed. Outcomes are presented as Kaplan-Meier event rates. RESULTS: Mean age was 72.6 ± 8.6 years, 90.8% were male, 36.8% were diabetics and 42.3% presented an acute coronary syndrome. ISR were treated with DES in 64.0% and with balloon angioplasty (BA) in 36.0%. After 10 years, the rates for all-cause mortality, TVMI and TLR were 58.2%, 15.4%, and 22.6%, respectively. No statistically relevant differences were found between the types of treatment (DES or BA) regarding all-cause mortality (55.7% vs. 63.2%, p = 0.181), TVMI (13.8% vs. 18.6%, p = 0.215) and TLR (21.8% vs. 25.0%, p = 0.764). Median time between first and recurrent ISR was 270.8 days. Recurrent ISR were treated with DES in a comparable proportion as during first ISR (p = 0.075). Independent predictor of TLR is patient age (p = 0.034). The median follow-up duration was 5.1 years (75% CI 2.8; 8.5). CONCLUSIONS: Clinical event rates after intervention of ISR located in SVG are high without statistically relevant differences regarding the type of treatment. However, further studies are needed.

13.
Arterioscler Thromb Vasc Biol ; 42(5): 527-539, 2022 05.
Artículo en Inglés | MEDLINE | ID: mdl-35321562

RESUMEN

Human platelets differ considerably with regard to their size, RNA content and thrombogenicity. Reticulated platelets (RPs) are young, hyper-reactive platelets that are newly released from the bone marrow. They are larger and contain more RNA compared to older platelets. In comparison to more mature platelets, they exhibit a significantly higher thrombogenicity and are known to be elevated in patients with an increased platelet turnover such as, diabetics and after acute myocardial infarction. Several studies have shown that RPs correlate with an insufficient antiplatelet response to aspirin and specific P2Y12 receptor inhibitors. In addition, RPs are promising novel biomarkers for the prediction of adverse cardiovascular events in cardiovascular disease. However, the reason for RPs intrinsic hyper-reactivity and their association with ischemic events is not completely understood and the biology of RPs is still under investigation. We here present a structured review of preclinical and clinical findings concerning the role of RPs in cardiovascular disease.


Asunto(s)
Plaquetas , Enfermedades Cardiovasculares , Aspirina/uso terapéutico , Plaquetas/fisiología , Humanos , Inhibidores de Agregación Plaquetaria/uso terapéutico , Recuento de Plaquetas , ARN
14.
J Immunol ; 206(1): 51-58, 2021 01 01.
Artículo en Inglés | MEDLINE | ID: mdl-33268482

RESUMEN

Obstructive sleep apnea syndrome (OSAS) represents a substantial disease of recurrent sleep fragmentation, leading to intermittent hypoxia and subsequent diseases such as cardiovascular, metabolic, or cognitive dysfunctions. In addition, OSAS is considered as low-grade systemic inflammation, which is associated with a higher incidence of cancer, severity of infections, and an overall immune dysregulation. This research project aims to comprehensively investigate the interplay of wholesome sleep and the immune functions of circulating monocytes and T cells in OSAS patients, which are known to be affected by oxidative stress. We studied the distribution of the CD14/CD16 characterized monocyte subsets in peripheral blood as well as their PD-L1 expression and complex formation with T cells. Furthermore, a detailed analysis of T cell subsets with regard to their PD-1 and PD-L1 expression was performed. Data revealed a decrease of classical monocytes accompanied by an increase of both CD16+ monocyte subsets in OSAS patients that was positively correlated with the body mass index. OSAS patients revealed an increased PD-1 and PD-L1 expression in T cells and monocytes, respectively, which was linked to the severity of monocyte subset alterations. The complex formation of monocytes and T cells was also elevated in OSAS patients, which indicates a deregulated PD-1/PD-L1 cross-talk between these cells. Our data show for the first time, to our knowledge, massive alterations of peripheral monocyte subsets in response to OSAS and its accompanying phenomena.


Asunto(s)
Antígeno B7-H1/metabolismo , Linfocitos T CD4-Positivos/inmunología , Linfocitos T CD8-positivos/inmunología , Monocitos/inmunología , Receptor de Muerte Celular Programada 1/metabolismo , Apnea Obstructiva del Sueño/inmunología , Adulto , Movimiento Celular , Células Cultivadas , Femenino , Humanos , Receptores de Lipopolisacáridos/metabolismo , Masculino , Persona de Mediana Edad , Receptor Cross-Talk , Receptores de IgG/metabolismo
15.
Audiol Neurootol ; 28(3): 211-218, 2023.
Artículo en Inglés | MEDLINE | ID: mdl-36634639

RESUMEN

INTRODUCTION: The amount of listening effort needed to understand speech in every-day life is an important outcome measure of the effectiveness of a hearing device. The main goal of this study was to assess subjective listening effort in patients implanted with an active middle ear implant Vibrant Soundbridge (VSB) with and without using their speech processor in complex acoustic scenarios. METHODS: Ten VSB users were measured using the adaptive categorical listening effort scaling (ACALES) method in four different acoustic scenarios, realized using a multichannel loudspeaker array. The four acoustic scenarios included both spatially simple and complex speech and noise arrangements that realistically simulated challenging every-day listening situations. Signal-to-noise ratios (SNRs) were adaptively varied during the measurement. Twelve normal-hearing (NH) listeners performed the same experiment as a control group. RESULTS: Listening effort was significantly reduced in all tested acoustic scenarios when participants used their VSB. When using the VSB, SNRs corresponding to mild-to-moderate listening effort were found not to be statistically different from SNRs found in the NH control group. SNRs corresponding to extreme listening effort of VSB users approached NH values, indicating partial restoration of listening effort. DISCUSSION AND CONCLUSIONS: Usage of the middle ear implant VSB was found to restore subjective listening effort to normal at high SNRs completely, and at lower SNRs partially. The remaining gap at low SNRs may be due to lower effectiveness of signal processing at high noise levels or due to the microphone location effect.


Asunto(s)
Prótesis Osicular , Percepción del Habla , Humanos , Esfuerzo de Escucha , Ruido , Percepción Auditiva , Acústica
16.
Sleep Breath ; 2023 Nov 06.
Artículo en Inglés | MEDLINE | ID: mdl-37926800

RESUMEN

BACKGROUND: Patients with obstructive or central sleep apnea are primarily treated with positive airway pressure treatment. There are novel implantable options targeting either obstructive sleep apnea using hypoglossal nerve stimulation (HNS) or central sleep apnea using phrenic nerve stimulation (PNS). METHODS: Patients with sleep apnea were implanted with both HNS and PNS devices, and their response to each therapy was monitored using home sleep tests as well as Epworth Sleepiness scale (ESS). RESULTS: We evaluated our concurrent neurostimulation approach in two patients. Both patients were implanted with two neuromodulation devices: The first case suffered from treatment emergent central sleep apnea after HNS activation for primarily obstructive sleep apnea (apnea-hypopnea index/AHI 54/h). The central portion resolved under PNS (AHI 23.7/h). The second case suffered from predominantly central sleep apnea (AHI 82/h). Here, the PNS device was implanted first, resulting in a subsequent reduction of the central portion. The residual obstructive sleep apnea was addressed using HNS (AHI 5.4/h). No interaction between the HNS and PNS systems was noticed in either of the two patients. CONCLUSIONS: In selected cases, a concurrent treatment with hypoglossal and phrenic nerve stimulation may lead to improvement of sleep apnea and patient satisfaction in a safe manner.

17.
Eur Arch Otorhinolaryngol ; 280(7): 3107-3118, 2023 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-36662266

RESUMEN

INTRODUCTION: Patients with otitis media (OM) encounter significant functional hearing impairment with conductive, or a combined hearing loss and long-term sequelae involving impaired speech/language development in children, reduced academic achievement and irreversible disorders of middle and inner ear requiring a long time therapy and/or multiple surgeries. In its persistent chronic form, Otitis media (COM) can often only be treated by undergoing ear surgery for hearing restoration. The persistent inflammatory reaction plays a major role, often caused by multi-resistant pathogens in the ear. Herein, we present outcomes of patients implanted with currently the only FDA approved active Middle Ear Implant Vibrant Soundbridge (VSB), suffering from persistent COM. METHODS: The study enrolled 42 patients, treated by performing middle ear (ME) surgery to different extents and implanted with the VSB to various structures in the ME. Included were 17 children and 25 adults that had recurrent and/or persisting OM and significant hearing loss. Preoperative and postoperative patients' audiometric data were evaluated and the benefit with VSB assessed using the Glasgow Benefit Inventory for adults and pediatric cohorts. The microbial spectrum of pathogens was assessed before and after surgery, exploring the colonization of the otopathogens, as well as the intestinal microbiome from individually burdened patients. RESULTS: The mean functional gain is 29.7 dB HL (range from 10 to 56.2 dB HL) with a significant improvement in speech intelligibility in quiet. Following VSB implantation, no significant differences in coupling were observed at low complication rates. Postoperatively patients showed significantly increased benefit with VSB compared to the untreated situation, including less otorrhea, pain, medical visits, and medication intake, with no recurrent OM and significant bacterial shift in otopathogens. The analysis of the intestinal microbiome displayed a high abundance of bacterial strains that might be linked to chronic and persistent inflammation. CONCLUSIONS: Functional ear surgery including rehabilitation with a VSB in patients suffering from COM present to be safe and effective. The successful acceptance accompanied by the improved audiological performance resulted in significant benefit with VSB, with a shift in the ear pathogens and altered microbiome and thus is a great opportunity to be treated.


Asunto(s)
Perdida Auditiva Conductiva-Sensorineural Mixta , Pérdida Auditiva , Prótesis Osicular , Otitis Media , Adulto , Humanos , Niño , Audición , Oído Medio/cirugía , Otitis Media/complicaciones , Otitis Media/cirugía , Pérdida Auditiva/etiología , Resultado del Tratamiento , Perdida Auditiva Conductiva-Sensorineural Mixta/cirugía
18.
Vasa ; 52(6): 386-393, 2023 Nov.
Artículo en Inglés | MEDLINE | ID: mdl-37840269

RESUMEN

Background: Finding the appropriate endovascular revascularization strategy for patients with peripheral artery disease and a popliteal artery lesion remains particulary challenging. Data regarding predictors for a beneficial outcome are scarce. Patients and methods: All endovascular procedures of popliteal artery lesions (n=227) performed in 197 patients between February 2009 and May 2018 at our institution were retrospectively analyzed. Hemodynamically relevant restenosis represented the primary endpoint. Results: The overall technical success rate was 98% and yielded 99% for stenoses (n=145) and 97% for occlusions (n=82). In a median follow-up of 10 months, the overall rate of restenosis was 23%. After 1 and 2 years, the primary patency rates were 76% and 55% and the secondary patency rate was 100%, respectively. The estimated probability of restenosis was significantly higher in stented lesions (stent vs. no stent; 36.0% vs. 19.1%; p=0.030). Multivariate analysis identified stent implantation (hazard ratio: 2.4; overall P=0.010) and diabetes (hazard ratio 2.0; P=0.023) as significant predictors for the development of restenosis. Conclusions: Endovascular therapy for popliteal artery disease was associated with high technical success rates and accompanied with a promising mid-term outcome, particularly in lesions treated with balloon angioplasty alone.


Asunto(s)
Angioplastia de Balón , Enfermedad Arterial Periférica , Humanos , Arteria Poplítea/diagnóstico por imagen , Arteria Poplítea/cirugía , Estudios Retrospectivos , Resultado del Tratamiento , Grado de Desobstrucción Vascular , Enfermedad Arterial Periférica/diagnóstico por imagen , Enfermedad Arterial Periférica/terapia , Angioplastia de Balón/efectos adversos , Angioplastia de Balón/métodos , Stents , Arteria Femoral
19.
Int Orthop ; 47(7): 1677-1687, 2023 07.
Artículo en Inglés | MEDLINE | ID: mdl-37195466

RESUMEN

PURPOSE: It is known that the magnitude of surgery and timing of surgical procedures represents a crucial step of care in polytraumatized patients. In contrast, it is not clear which specific factors are most critical when evaluating the surgical load (physiologic burden to the patient incurred by surgical procedures). Additionally, there is a dearth of evidence for which body region and surgical procedures are associated with high surgical burden. The aim of this study was to identify key factors and quantify the surgical load for different types of fracture fixation in multiple anatomic regions. METHODS: A standardized questionnaire was developed by experts from Société Internationale de Chirurgie Orthopédique et de Traumatologie (SICOT)-Trauma committee. Questions included relevance and composition of the surgical load, operational staging criteria, and stratification of operation procedures in different anatomic regions. Quantitative values according to a five-point Likert scale were chosen by the correspondents to determine the surgical load value based on their expertise. The surgical load for different surgical procedures in different body regions could be chosen in a range between "1," defined as the surgical load equivalent to external (monolateral) fixator application, and "5," defined as the maximal surgical load possible in that specific anatomic region. RESULTS: This questionnaire was completed online by 196 trauma surgeons from 61 countries in between Jun 26, 2022, and July 16, 2022 that are members of SICOT. The surgical load (SL) overall was considered very important by 77.0% of correspondents and important by 20.9% correspondents. Intraoperative blood loss (43.2%) and soft tissue damage (29.6%) were chosen as the most significant factors by participating surgeons. The decision for staged procedures was dictated by involved body region (56.1%), followed by bleeding risk (18.9%) and fracture complexity (9.2%). Percutaneous or intramedullary procedures as well as fractures in distal anatomic regions, such as hands, ankles, and feet, were consistently ranked lower in their surgical load. CONCLUSION: This study demonstrates a consensus in the trauma community about the crucial relevance of the surgical load in polytrauma care. The surgical load is ranked higher with increased intraoperative bleeding and greater soft tissue damage/extent of surgical approach and depends relevantly on the anatomic region and kind of operative procedure. The experts especially consider anatomic regions and the risk of intraoperative bleeding as well as fracture complexity to guide staging protocols. Specialized guidance and teaching is required to assess both the patient's physiological status and the estimated surgical load reliably in the preoperative decision-making and operative staging.


Asunto(s)
Fracturas Óseas , Humanos , Fracturas Óseas/cirugía , Fijación de Fractura/efectos adversos , Fijación de Fractura/métodos , Encuestas y Cuestionarios , Tobillo , Consenso
20.
Int Orthop ; 47(9): 2301-2318, 2023 09.
Artículo en Inglés | MEDLINE | ID: mdl-37328569

RESUMEN

PURPOSE: Unstable pelvic ring injury can result in a life-threatening situation and lead to long-term disability. Established classification systems, recently emerged resuscitative and treatment options as well as techniques, have facilitated expansion in how these injuries can be studied and managed. This study aims to access practice variation in the management of unstable pelvic injuries around the globe. METHODS: A standardized questionnaire including 15 questions was developed by experts from the SICOT trauma committee (Société Internationale de Chirurgie Orthopédique et de Traumatologie) and then distributed among members. The survey was conducted online for one month in 2022 with 358 trauma surgeons, encompassing responses from 80 countries (experience > 5 years = 79%). Topics in the questionnaire included surgical and interventional treatment strategies, classification, staging/reconstruction procedures, and preoperative imaging. Answer options for treatment strategies were ranked on a 4-point rating scale with following options: (1) always (A), (2) often (O), (3) seldom (S), and (4) never (N). Stratification was performed according to geographic regions (continents). RESULTS: The Young and Burgess (52%) and Tile/AO (47%) classification systems were commonly used. Preoperative three-dimensional (3D) computed tomography (CT) scans were utilized by 93% of respondents. Rescue screws (RS), C-clamps (CC), angioembolization (AE), and pelvic packing (PP) were observed to be rarely implemented in practice (A + O: RS = 24%, CC = 25%, AE = 21%, PP = 25%). External fixation was the most common method temporized fixation (A + O = 71%). Percutaneous screw fixation was the most common definitive fixation technique (A + O = 57%). In contrast, 3D navigation techniques were rarely utilized (A + O = 15%). Most standards in treatment of unstable pelvic ring injuries are implemented equally across the globe. The greatest differences were observed in augmented techniques to bleeding control, such as angioembolization and REBOA, more commonly used in Europe (both), North America (both), and Oceania (only angioembolization). CONCLUSION: The Young-Burgess and Tile/AO classifications are used approximately equally across the world. Initial non-invasive stabilization with binders and temporary external fixation are commonly utilized, while specific haemorrhage control techniques such as pelvic packing and angioembolization are rarely and REBOA almost never considered. The substantial regional differences' impact on outcomes needs to be further explored.


Asunto(s)
Fracturas Óseas , Huesos Pélvicos , Humanos , Fracturas Óseas/cirugía , Fijación Interna de Fracturas/métodos , Huesos Pélvicos/cirugía , Huesos Pélvicos/lesiones , Tomografía Computarizada por Rayos X , Pelvis , Estudios Retrospectivos
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