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1.
BMJ Open ; 14(9): e081347, 2024 Sep 05.
Artículo en Inglés | MEDLINE | ID: mdl-39237273

RESUMEN

INTRODUCTION: Hypertension is a major cause of premature death worldwide as it is an important risk factor for coronary artery disease, myocardial infarction, heart failure and stroke. Although an estimated 1.3 billion adults suffer from hypertension, less than half of them are diagnosed correctly and therefore receive sufficient treatment. Furthermore, only one fifth of those treated reach the therapy target of normotension. This significant deficit underlines the need for new therapy concepts to improve long-term health outcomes. Several studies have shown positive effects of digital health programmes in the disease management of ambulatory, long-term hypertension treatment. More research is needed to explore the abilities of digital health programmes as an innovative pathway in ambulatory healthcare.The eXPLORE study aims to evaluate the feasibility of a clinical trial on the impact of a supplementary digital therapy programme for the treatment of primary arterial hypertension. METHODS AND ANALYSES: The eXPLORE study collects data in the setting of a prospective randomised controlled trial to evaluate methodological feasibility for larger-scaled follow-up research. The study compares a digital therapy programme using a smartphone application that is based on functions and algorithms creating tasks and recommendations based on individual health data to standard care for the treatment of primary arterial hypertension. The study period is 180 days, with a 90-day in-life phase followed by a 90-day follow-up phase. Baseline and follow-up data (3 months, 6 months follow-up) of all participants included is collected via questionnaire surveys as well as self-administered blood pressure monitoring. Patient inclusion, initial data acquisition and follow-up were carried out in an innovative remote setting. The study was initiated in November 2022 and is currently ongoing. Study outcome measures are changes in mean blood pressure, health literacy and self-sufficient health behaviour. ETHICS AND DISSEMINATION: The eXPLORE study is carried out in accordance with all applicable legal regulations. Cost-effectiveness is assured by continuous evaluation and documentation over the course of the study. All health-relevant data from the eXPLORE study will be provided for analyses and publication to the investigators of LMU Hospital. The study was approved by the local ethics committee of LMU Munich (project nr.: 22-0115). TRIAL REGISTRATION: NCT05580068. PROTOCOL VERSION: 1.5, 28.08.2023.


Asunto(s)
Estudios de Factibilidad , Hipertensión , Aplicaciones Móviles , Humanos , Hipertensión/terapia , Telemedicina , Estudios Prospectivos , Ensayos Clínicos Controlados Aleatorios como Asunto , Teléfono Inteligente , Adulto , Masculino , Femenino , Monitoreo Ambulatorio de la Presión Arterial/métodos , Presión Sanguínea
2.
Cardiovasc Revasc Med ; 66: 35-40, 2024 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-38553275

RESUMEN

BACKGROUND: Limited data are available regarding myocardial injury and its risk factors in percutaneous coronary interventions (PCI) of severe calcified lesions using orbital atherectomy (OA). METHODS: Patients who underwent OA at our institution were retrospectively enrolled into the present registry. High-sensitive Troponin I (hsTroponin I), EKG and echocardiography were used to assess myocardial injury after the procedure. RESULTS: A total of 27 patients between who underwent OA between January 2022 and June 2023 were included. Myocardial injury (elevation of hsTroponin I above the 99th percentile upper reference limit) occurred in all patients. Median hsTroponin I on the first day after the procedure was 1093 (557-4037) ng/l with a minimum of 86 ng/l and a maximum of 25,756 ng/l. Myocardial infarction occurred in two patients (7 %), who had severe coronary dissection after OA. Lesions were longer (47 [38-52] mm vs. 20 [14-47] mm; p = 0.009) in patients with hsTroponin I levels above the median compared to those with levels below. Furthermore, a moderate correlation between hsTroponin I and lesion length was detected (r = 0.54; p = 0.004). CONCLUSIONS: In the present study myocardial injury occurred in all patients after OA without loss of viable myocardium in the majority of patients. Lesions length was found to be a significant factor associated with markedly increased hsTroponin I after the OA procedure.


Asunto(s)
Aterectomía Coronaria , Biomarcadores , Enfermedad de la Arteria Coronaria , Sistema de Registros , Troponina I , Calcificación Vascular , Humanos , Masculino , Femenino , Estudios Retrospectivos , Anciano , Aterectomía Coronaria/efectos adversos , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Enfermedad de la Arteria Coronaria/terapia , Factores de Riesgo , Resultado del Tratamiento , Troponina I/sangre , Biomarcadores/sangre , Persona de Mediana Edad , Calcificación Vascular/diagnóstico por imagen , Calcificación Vascular/terapia , Factores de Tiempo , Índice de Severidad de la Enfermedad , Medición de Riesgo , Intervención Coronaria Percutánea/efectos adversos , Intervención Coronaria Percutánea/instrumentación , Anciano de 80 o más Años , Electrocardiografía , Infarto del Miocardio/etiología , Infarto del Miocardio/diagnóstico por imagen
3.
Internist (Berl) ; 62(11): 1180-1190, 2021 Nov.
Artículo en Alemán | MEDLINE | ID: mdl-34648044

RESUMEN

Digital health solutions, applications of artificial intelligence (AI) and new technologies, such as cardiac magnetic resonance imaging and cardiac human genetics are currently being validated in cardiac healthcare pathways. They show promising approaches for improving existing healthcare structures in the future by strengthening the focus on predictive, preventive and personalized medicine. In addition, the accompanying use of digital health applications will become increasingly more important in the future healthcare, especially in patients with chronic diseases. In this article, the authors describe a case of chronic heart failure (HF) as an example to provide an overview of how digitalized healthcare can be efficiently designed across sectors and disciplines in the future. Moreover, the importance of a self-determined patient management for the treatment process itself is underlined. Since HF is frequently accompanied by various comorbidities during the course of the disease that are often recognized only after a delay, the necessity for a timely simultaneous and preventive treatment of multiple comorbidities in cardiovascular diseases is emphasized. Against this background the currently separately applied disease management programs (DMP) are critically questioned. The development of a holistic DMP encompassing all indications for the treatment of chronic diseases may pave the way to a more efficient medical care system.


Asunto(s)
Inteligencia Artificial , Insuficiencia Cardíaca , Atención a la Salud , Predicción , Corazón , Insuficiencia Cardíaca/diagnóstico , Insuficiencia Cardíaca/terapia , Humanos
4.
Eur J Radiol ; 130: 109136, 2020 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-32634756

RESUMEN

PURPOSE: To prospectively evaluate contemporary indications, safety and diagnostic impact of cardiac CTA in patients undergoing cardiac CTA examinations for non-coronary clinical indications. METHOD: We analyzed 1097 consecutive patients from the German Cardiac CT Registry who underwent cardiac CTA between 2009 and 2014 due to clinically indicated non-coronary reasons using 64-slice or newer CT systems in twelve tertiary German heart centers in order to evaluate the impact of clinical indications on procedure-associated parameters. All participating centers electronically submitted patient and examination data including detailed indications, clinical symptoms, procedural parameters, complications and diagnostic results in a predefined template. RESULTS: The most frequent indication for non-coronary cardiac CTA was the evaluation of pulmonary vein anatomy (65.9 %, 723/1097). In the remaining cases, most frequent indications were planning before TAVI (44.5 %, 69/155), evaluation of valvular disease (31.6 %, 49/155), and evaluation of implants (5.8 %, 9/155). Non-coronary cardiac CTA required a median amount of iodinated contrast agent of 100.0 mL (IQR 95.0-110.0 mL). Prospectively ECG-triggered acquisition was the most frequently used protocol (74.0 %), followed by retrospectively ECG-gated acquisition with and without tube current modulation (19.9 % and 6.0 %, respectively), resulting in a mean estimated effective dose of 5.2 mSv (IQR 2.9-9.5 mSv, average conversion factor k = 0.026). Overall, complication rate was very low (1.5 %). Non-coronary cardiac CTA revealed a new clinical diagnostic aspect in 3.2 % of all patients, and a new main clinical diagnosis in 2.2 %. CONCLUSIONS: Non-coronary cardiac CTA as a routinely applied diagnostic modality is associated with a very low procedure-related rate of complications and reasonably low radiation exposure using contemporary CT systems.


Asunto(s)
Angiografía por Tomografía Computarizada/métodos , Angiografía Coronaria/métodos , Dosis de Radiación , Exposición a la Radiación/estadística & datos numéricos , Anciano , Estudios de Cohortes , Femenino , Alemania , Humanos , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Sistema de Registros/estadística & datos numéricos , Estudios Retrospectivos
5.
Int J Cardiovasc Imaging ; 35(4): 741-748, 2019 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-30456460

RESUMEN

To evaluate diagnostic impact of clinical use of coronary computed tomography angiography (CCTA) in patients with suspected stable coronary artery disease (CAD) and its consequences in daily practice for patient management, depending on stress test results in daily practice. Between 2009 and 2014 of a total population of 1352 patients of the German Cardiac Computed Tomography (CT) Registry who had previously undergone stress tests, CCTA visualizations were carried out on the coronary arteries with suspected stable CAD. Patients were divided into three groups according to stress test results: Group 1 with inconclusive (n = 178, 13.2%), Group 2 with ischemia in stress test (n = 372, 27.5%) and Group 3 without ischemia in stress test (n = 802, 59.3%). The test of preference was the stress electrocardiogram (ECG), which was performed more frequently in patients without ischemia in stress test as compared to those with ischemia (96.3% vs. 93.0%, p = 0.015). The incidence of detected obstructive CAD was lower in patients with suggested ischemia in stress test as compared to patients with inconclusive results (14.1% vs. 21.1%, p = 0.037). There was no difference in the incidence of an obstructive CAD in patients with and without ischemia in stress test (14.1% vs. 15.8%, p = 0.440). CCTA is a reliable, non-invasive option for ruling-out obstructive CAD irrespective of the stress test result.


Asunto(s)
Angiografía por Tomografía Computarizada/métodos , Angiografía Coronaria/métodos , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Electrocardiografía , Prueba de Esfuerzo , Tomografía Computarizada Multidetector/métodos , Anciano , Toma de Decisiones Clínicas , Enfermedad de la Arteria Coronaria/fisiopatología , Enfermedad de la Arteria Coronaria/terapia , Femenino , Alemania , Humanos , Masculino , Persona de Mediana Edad , Valor Predictivo de las Pruebas , Pronóstico , Sistema de Registros , Reproducibilidad de los Resultados
6.
J Cardiovasc Comput Tomogr ; 12(1): 34-41, 2018.
Artículo en Inglés | MEDLINE | ID: mdl-29195843

RESUMEN

BACKGROUND: Coronary computed tomography angiography (coronary CTA) provides non-invasive evaluation of the coronary arteries with high precision for the detection of significant coronary artery disease (CAD). AIM: To investigate whether irregular heart rhythm including atrial fibrillation and premature beats during data acquisition influences (i) radiation and contrast media exposure, (ii) number of non-evaluable coronary segments and (iii) diagnostic impact of coronary CTA. METHODS: Twelve tertiary care centers with ≥64 slice CT scanners and ≥5 years of experience with cardiovascular imaging participated in this registry. Between 2009 and 2014, 4339 examinations were analysed in patients who underwent clinically indicated coronary CTA for suspected CAD. Clinical and epidemiologic data were gathered from all patients. In addition, clinical presentation, heart rate and rhythm during the scan, Agatston score, radiation and contrast media exposure and the diagnostic impact of coronary CTA were systematically analysed. RESULTS: Of 4339 patients in total, 260 (6.0%) had irregular heart rhythm, whereas the remaining 4079 (94.0%) had stable sinus rhythm. Patients with irregular heart rhythm were older (63.2 ± 12.5yrs versus 58.6 ± 11.4yrs. p < 0.001), exhibited a higher rate of pathologic stress tests before CTA (37.1% versus 26.1%, p < 0.01) and higher heart rates during CTA compared to those with sinus rhythm (62.5 ± 11.6bpm versus 58.9 ± 8.5bpm, p < 0.001). Both contrast media exposure and radiation exposure were significantly higher in patients with irregular heart rhythm (90 mL (95%CI = 80-110 mL) versus 80 mL (95%CI = 70-90 mL) and 6.2 mSv (95%CI = 2.5-11.7) versus 3.3 mSv (95%CI = 1.7-6.9), p < 0.001 for both). Coronary CTA excluded significant CAD less frequently in patients with irregular heart rhythm (32.9% versus 44.8%, p < 0.001). This was attributed to the higher rate of examinations with at least one non-diagnostic coronary segment in patients with irregular heart rhythm (10.8% versus 4.6%, p < 0.001). Subsequent invasive angiography could be avoided in 47.2% of patients with irregular heart rhythm compared to 52.9% of patients with sinus rhythm (p = NS), whereas downstream stress testing was recommended in 3.2% of patients with irregular heart rhythm versus 4.0% of patients with sinus rhythm (p = NS). CONCLUSION: A significant number of patients scheduled for coronary CTA have irregular heart rhythm in a real-world clinical setting. In such patients, heart rate during coronary CTA is higher, possibly resulting in (i) higher radiation and contrast agent exposure and (ii) more frequent coronary CTA examinations with at least one non-diagnostic coronary artery segment. However, this does not seem to lead to increased downstream stress testing or subsequent invasive procedures.


Asunto(s)
Fibrilación Atrial/fisiopatología , Complejos Cardíacos Prematuros/fisiopatología , Angiografía por Tomografía Computarizada , Angiografía Coronaria/métodos , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Vasos Coronarios/diagnóstico por imagen , Frecuencia Cardíaca , Tomografía Computarizada Multidetector , Dosis de Radiación , Exposición a la Radiación , Anciano , Fibrilación Atrial/diagnóstico , Fibrilación Atrial/epidemiología , Complejos Cardíacos Prematuros/diagnóstico , Complejos Cardíacos Prematuros/epidemiología , Medios de Contraste/administración & dosificación , Enfermedad de la Arteria Coronaria/epidemiología , Enfermedad de la Arteria Coronaria/fisiopatología , Femenino , Alemania/epidemiología , Humanos , Masculino , Persona de Mediana Edad , Valor Predictivo de las Pruebas , Sistema de Registros , Reproducibilidad de los Resultados
7.
Int J Cardiovasc Imaging ; 34(5): 807-819, 2018 May.
Artículo en Inglés | MEDLINE | ID: mdl-29197025

RESUMEN

Cardiac computed tomography permits quantification of coronary calcification as well as detection of coronary artery stenoses after contrast enhancement. Moreover, cardiac CT offers high-resolution morphologic and functional imaging of cardiac structures which is valuable for various structural heart disease interventions and electrophysiology procedures. So far, only limited data exist regarding the spectrum of indications, image acquisition parameters as well as results and clinical consequences of cardiac CT examinations using state-of-the-art CT systems in experienced centers. Twelve cardiology centers with profound expertise in cardiovascular imaging participated in the German Cardiac CT Registry. Criteria for participation included adequate experience in cardiac CT as well of the availability of a 64-slice or newer CT system. Between 2009 and 2014, 7061 patients were prospectively enrolled. For all cardiac CT examinations, patient parameters, procedural data, indication and clinical consequences of the examination were documented. Mean patient age was 61 ± 12 years, 63% were males. The majority (63%) of all cardiac CT examinations were performed in an outpatient setting, 37% were performed during an inpatient stay. 91% were elective and 9% were scheduled in an acute setting. In most examinations (48%), reporting was performed by cardiologists, in 4% by radiologists and in 47% of the cases as a consensus reading. Cardiac CT was limited to native acquisitions for assessment of coronary artery calcification in 9% of patients, only contrast-enhanced coronary CT angiography was performed in 16.6% and combined native and contrast-enhanced coronary CT angiography was performed in 57.7% of patients. Non-coronary cardiac CT examinations constituted 16.6% of all cases. Coronary artery calcification assessment was performed using prospectively ECG-triggered acquisition in 76.9% of all cases. The median dose length product (DLP) was 42 mGy cm (estimated effective radiation dose of 0.6 mSv). Coronary CT angiography was performed using prospectively ECG-triggered acquisition in 77.3% of all cases. Tube voltage was 120 kV in 67.8% of patients and 100 kV in 30.7% of patients, with a resultant median DLP of 256 mGy cm (estimated effective dose of 3.6 mSv). Clinical consequences of cardiac CT were as follows: in 46.8% of the cases, invasive coronary angiography could be avoided; ischemia testing was recommended in 4.7% of the cases, invasive coronary angiography was recommended in 16.4% of the cases and change in medication in 21.6% of the examinations. Cardiac CT is performed in the majority of patients for non-invasive evaluation of the coronary arteries. CT frequently resulted in medication change, and otherwise planned downstream testing including invasive angiography could be avoided in a high percentage of patients. Radiation exposure in experienced centers is relatively low.


Asunto(s)
Angiografía por Tomografía Computarizada/métodos , Angiografía Coronaria/métodos , Vasos Coronarios/diagnóstico por imagen , Cardiopatías/diagnóstico por imagen , Corazón/diagnóstico por imagen , Tomografía Computarizada Multidetector/métodos , Anciano , Técnicas de Imagen Sincronizada Cardíacas , Angiografía por Tomografía Computarizada/efectos adversos , Angiografía Coronaria/efectos adversos , Vasos Coronarios/fisiopatología , Electrocardiografía , Femenino , Alemania , Corazón/fisiopatología , Cardiopatías/fisiopatología , Cardiopatías/terapia , Humanos , Masculino , Persona de Mediana Edad , Tomografía Computarizada Multidetector/efectos adversos , Valor Predictivo de las Pruebas , Pronóstico , Estudios Prospectivos , Dosis de Radiación , Exposición a la Radiación , Interpretación de Imagen Radiográfica Asistida por Computador , Sistema de Registros , Reproducibilidad de los Resultados
8.
Clin Res Cardiol ; 106(11): 905-912, 2017 Nov.
Artículo en Inglés | MEDLINE | ID: mdl-28725938

RESUMEN

BACKGROUND: Coronary computed tomography angiography (CTA) is increasingly used as a test to rule out coronary artery disease (CAD) in patients with a low to intermediate pre-test probability of the disease. We used the database of the German CT registry, collected between 2009 and 2014 in a broad patient population, to analyze contemporary radiation dose associated with coronary CTA in clinical practice. PATIENTS AND METHODS: The prospective observational registry included a total of 7061 patients ≥18 years, referred to 12 participating centers for a clinically indicated cardiac CT examination. All centers were cardiology units well experienced in CTA and used multi-slice CT scanners with at least 64 rows. Coronary CTA was performed in a subset of 5001 patients, 59.6 ± 11.8 years, body mass index (BMI) 26.9 ± 4.5 kg/m2, 38% females. Three time periods with approximately equal numbers of patients were created (01/09-03/10, 04/10-03/11, 04/11-07/14). The dose-length product of all examinations and derived effective dose in mSv (conversion factor k = 0.014) as well as the influence of patient characteristics on dose were compared for the three time periods. RESULTS: BMI and proportion of female patients remained stable over time, and mean heart rate decreased from 60.3 ± 9.0 to 58.5 ± 9.3 bpm from the first to the last time period (p < 0.001). Overall, the mean effective dose of coronary CTA was 3.6 mSv (Q1 1.8 mSv, Q3 7.4 mSv). Within the three time periods, it declined from 5.6 (2.7, 8.6) mSv during the first to 4.8 (2.1, 8.2) mSv during the second and 2.5 (1.3, 4.6) mSv during the last time period (p < 0.001). Paralleling the decline in radiation dose over time, the proportion of prospectively ECG-triggered examinations increased (68, 79, 83%; p < 0.001), and the proportion of examinations with retrospective gating and no tube current modulation decreased (5.3, 4.0, 1.6%; p < 0.001). Tube current (mAs) and voltage (kV) both decreased over time. In multivariable analysis, besides earlier time period, further independent predictors of an increased radiation dose were older age, higher heart rate, and higher BMI as well as the technical factors higher mAs, higher kV, and retrospective gating. At three sites, CT scanners with improved technology were installed during the last time period. CONCLUSIONS: In current clinical practice among German cardiology units with specific expertise in cross-sectional cardiovascular imaging, overall radiation dose of coronary CTA was comparably low. Over time, a decline in radiation dose was demonstrated, probably due to a combination of improvements in data acquisition protocols and patient preparation as well as installation of new CT scanners with advanced technology.


Asunto(s)
Angiografía por Tomografía Computarizada/métodos , Angiografía Coronaria/métodos , Enfermedad de la Arteria Coronaria/diagnóstico , Vasos Coronarios/efectos de la radiación , Traumatismos por Radiación/prevención & control , Sistema de Registros , Medición de Riesgo/métodos , Vasos Coronarios/diagnóstico por imagen , Estudios Transversales , Femenino , Alemania/epidemiología , Humanos , Incidencia , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Dosis de Radiación , Traumatismos por Radiación/epidemiología
9.
Int J Cardiol ; 205: 23-30, 2016 Feb 15.
Artículo en Inglés | MEDLINE | ID: mdl-26709136

RESUMEN

OBJECTIVE: In animal models, G-CSF based progenitor cell mobilization combined with a DPP4 inhibitor leads to increased homing of bone marrow derived progenitor cells to the injured myocardium via the SDF1/CXCR4 axis resulting in improved ejection fraction and survival after acute myocardial infarction (AMI). RESEARCH DESIGN AND METHODS: After successful revascularization in AMI, 174 patients were randomized 1:1 in a multi-centre, prospective, placebo-controlled, parallel group, double blind, phase III efficacy and safety trial to treatment with G-CSF and Sitagliptin (GS) or placebo. Diabetic and non-diabetic patients were included in our trial. The primary efficacy endpoint hierarchically combined global left and right ventricular ejection fraction changes from baseline to 6 months of follow-up (ΔLVEF, ΔRVEF), as determined by cardiac MRI. RESULTS: At follow-up ΔLVEF as well as ΔRVEF did not differ between the GS and placebo group. Patients in the placebo group had a similar risk for a major adverse cardiac event within 12 months of follow-up as compared to patients under GS. CONCLUSION: Progenitor cell therapy comprising the use of G-CSF and Sitagliptin after successfully revascularized acute myocardial infarction fails to show a beneficial effect on cardiac function and clinical events after 12 months. (EudraCT: 2007-003,941-34; ClinicalTrials.gov: NCT00650143, funding: Heinz-Nixdorf foundation).


Asunto(s)
Factor Estimulante de Colonias de Granulocitos/administración & dosificación , Infarto del Miocardio/diagnóstico , Infarto del Miocardio/terapia , Fosfato de Sitagliptina/administración & dosificación , Trasplante de Células Madre/métodos , Anciano , Método Doble Ciego , Quimioterapia Combinada , Femenino , Estudios de Seguimiento , Factor Estimulante de Colonias de Granulocitos/efectos adversos , Humanos , Masculino , Persona de Mediana Edad , Infarto del Miocardio/epidemiología , Estudios Prospectivos , Fosfato de Sitagliptina/efectos adversos , Trasplante de Células Madre/efectos adversos , Volumen Sistólico/efectos de los fármacos , Volumen Sistólico/fisiología , Resultado del Tratamiento
10.
Clin Imaging ; 38(5): 675-80, 2014.
Artículo en Inglés | MEDLINE | ID: mdl-24993639

RESUMEN

BACKGROUND: Functional assessment of myocardial perfusion in computed tomography (CT) is a challenge. OBJECTIVE: To evaluate CT dynamic myocardial perfusion imaging (MPI) using a wide-detector scanner. METHODS: Time to peak (TTP), peak enhancement (PE), upslope (US), and the area under the curve (AUC) were calculated in 12 pigs (256-slice multidetector CT scanner). RESULTS: The entire myocardium was covered by the scan volume. TTP was increased, and PE, US, and AUC were decreased in poststenotic myocardium. CONCLUSION: CT MPI with complete coverage of the myocardium is feasible, providing evaluation of the physiological significance of coronary artery stenosis.


Asunto(s)
Circulación Coronaria/fisiología , Tomografía Computarizada Multidetector/instrumentación , Isquemia Miocárdica/diagnóstico por imagen , Imagen de Perfusión Miocárdica/métodos , Animales , Diseño de Equipo , Femenino , Isquemia Miocárdica/fisiopatología , Reproducibilidad de los Resultados , Porcinos
11.
Am J Cardiovasc Dis ; 4(2): 87-99, 2014.
Artículo en Inglés | MEDLINE | ID: mdl-25006536

RESUMEN

OBJECTIVES: Few data is available comparing Edwards SAPIEN XT - SXT (Edwards Lifesciences, Irvine, California) with Medtronic CoreValve - CoV (Medtronic Inc., Minneapolis, Minnesota) in patients with severe aortic stenosis undergoing transcatheter aortic valve replacement (TAVR). METHODS: We selected consecutive patients undergoing transfemoral TAVR with SXT or CoV at our Institution. Main outcomes were Valve Academic Research Consortium (VARC)-combined safety endpoints. RESULTS: A total of 100 patients (SXT, n=50 versus CoV, n=50) were analyzed. Both SXT and CoV showed good device success rates (98% versus 90%, p=0.20). SXT versus CoV reduced the occurrence of paravalvular regurgitation after TAVR (26% versus 90%, p<0.0001) though not affecting the rate of moderate/severe regurgitation (p=0.20). SXT versus CoV required less frequently a permanent pacemaker after TAVR (8% versus 38%, p<0.0001). In-hospital major vascular complications (8% versus 4%, p>0.99), life-threatening bleedings (2% versus 4%, p>0.99), stroke (4% versus 6%, p>0.99) and death (6% versus 2%, p>0.99) did not differ between SXT and CoV. However, safety endpoints favored SXT (17% versus 34.6%, p=0.01), due to a numerically higher incidence of ischemic stroke and Acute Kidney Injury Stage 3 after CoV. At multivariate analysis, TAVR with SXT (odds ratio=0.21, 95% confidence intervals [0.05-0.84], p=0.03) was predictive of fewer adverse events. CONCLUSIONS: Transcatheter valve implantation with Edwards SAPIEN XT was associated with lower VARC-combined safety endpoints as compared with Medtronic CoreValve. More extensive cohorts are needed to confirm these results.

12.
J Magn Reson Imaging ; 40(3): 709-14, 2014 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-24470317

RESUMEN

PURPOSE: To characterize the evolution of right ventricular (RV) function post-myocardial infarction (MI), to describe the culprit vessel involved with RV injury and to assess the concordance between RV injury on magnetic resonance imaging (MRI) and RV infarct on electrocardiogram (EKG). MATERIALS AND METHODS: Thirty-one patients underwent cardiovascular magnetic resonance (CMR) examinations at three time frames post-ST elevation MI (STEMI). RESULTS: Of those with an initial normal scan, RV function did not significantly change over time (60.6 ± 6.3, 57.8 ± 6.0, 55.4 ± 5.7, P > 0.05). However, in those whose RVEF (RV ejection fraction) was initially low, it significantly increased from the first scan to the third scan (46.2 ± 3.6, 50 ± 6.6, 51.3 ± 5.2, P < 0.01). Post-hoc testing revealed a significant difference between the 48-hour and the 6-month scan, and between the 48-hour and the 3-week scan; however, there was no significant difference between the 3-week and 6-month scans. Interestingly, 23% of patients with low RVEF at baseline had the left anterior descending (LAD) as the culprit vessel. Only 15% of the low RVEF at baseline group were classified as having an RVMI by EKG criteria. CONCLUSIONS: The optimal timepoint to assess for RV injury via CMR may be 3 weeks post-acute MI. Standard EKG criteria may underestimate RV injury when compared to CMR.


Asunto(s)
Imagen por Resonancia Magnética/métodos , Infarto del Miocardio/fisiopatología , Infarto del Miocardio/terapia , Disfunción Ventricular Derecha/fisiopatología , Medios de Contraste , Electrocardiografía , Femenino , Humanos , Masculino , Persona de Mediana Edad , Compuestos Organometálicos , Intervención Coronaria Percutánea/métodos , Pronóstico , Estudios Prospectivos
13.
Eur Heart J Cardiovasc Imaging ; 14(12): 1174-80, 2013 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-23907345

RESUMEN

AIMS: To assess image quality and diagnostic performance of 3.0 Tesla (3T) cardiac magnetic resonance (CMR) myocardial perfusion imaging with a dual radiofrequency source to detect functional relevant coronary artery disease (CAD), using coronary angiography and invasive pressure-derived fractional flow reserve (FFR) as reference standard. METHODS AND RESULTS: We included 116 patients with suspected or known CAD, who underwent 3T adenosine myocardial perfusion CMR (resolution 2.97 × 2.97 mm) and coronary angiography plus FFR measurements in intermediate lesions. Image quality of myocardial perfusion CMR was graded on a 4-point scale (1 = poor to 4 = excellent). Diagnostic accuracy was assessed by ROC analyses using a 16-myocardial segment-based summed perfusion score (0 = normal to 3 = transmural perfusion defect) and by determining sensitivity, specificity, positive and negative predictive value on the coronary vessel territory and the patient level. Diagnostic image quality was achieved for all stress myocardial perfusion CMR studies with an average quality score of 2.5, 3.1, and 3.0 for LAD, LCX, and RCA territories. The ability of the myocardial perfusion CMR perfusion score to detect significant coronary artery stenosis yielded an area under the curve of 0.93 on ROC analysis. Values for sensitivity, specificity, positive and negative predictive value on a vessel territory level and the patient level were 89, 95, 87, 96% and 85, 87, 77, 92%, respectively. CONCLUSION: In patients with suspected or known significant CAD, 3T myocardial perfusion CMR with standard perfusion protocols provides consistently high image quality and an excellent diagnostic performance.


Asunto(s)
Angiografía Coronaria/métodos , Enfermedad de la Arteria Coronaria/diagnóstico , Reserva del Flujo Fraccional Miocárdico , Imagen por Resonancia Cinemagnética/métodos , Isquemia Miocárdica/diagnóstico , Imagen de Perfusión Miocárdica/métodos , Anciano , Cateterismo Cardíaco/métodos , Estudios de Cohortes , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Femenino , Estudios de Seguimiento , Humanos , Masculino , Persona de Mediana Edad , Isquemia Miocárdica/diagnóstico por imagen , Variaciones Dependientes del Observador , Curva ROC , Estudios Retrospectivos , Medición de Riesgo , Sensibilidad y Especificidad , Índice de Severidad de la Enfermedad
14.
Cardiovasc Diabetol ; 12: 117, 2013 Aug 16.
Artículo en Inglés | MEDLINE | ID: mdl-23953602

RESUMEN

BACKGROUND: GLP-1 is an incretine hormone which gets secreted from intestinal L-cells in response to nutritional stimuli leading to pancreatic insulin secretion and suppression of glucagon release. GLP-1 further inhibits gastric motility and reduces appetite which in conjunction improves postprandial glucose metabolism. Additional vasoprotective effects have been described for GLP-1 in experimental models. Despite these vasoprotective actions, associations between endogenous levels of GLP-1 and cardiovascular disease have yet not been investigated in humans which was the aim of the present study. METHODS: GLP-1 serum levels were assessed in a cohort of 303 patients receiving coronary CT-angiography due to typical or atypical chest pain. RESULTS: GLP-1 was found to be positively associated with total coronary plaque burden in a fully adjusted model containing age, sex, BMI, hypertension, diabetes mellitus, smoking, triglycerides, LDL-C (low density lipoprotein cholesterol), hsCRP (high-sensitive C-reactive protein), and eGFR (estimated glomerular filtration rate) (OR: 2.53 (95% CI: 1.12 - 6.08; p = 0.03). CONCLUSION: Circulating GLP-1 was found to be positivity associated with coronary atherosclerosis in humans. The clinical relevance of this observation needs further investigations.


Asunto(s)
Enfermedad de la Arteria Coronaria/sangre , Péptido 1 Similar al Glucagón/sangre , Anciano , Biomarcadores/sangre , Angiografía Coronaria/métodos , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Vasos Coronarios/diagnóstico por imagen , Femenino , Humanos , Masculino , Persona de Mediana Edad , Tomografía Computarizada Multidetector , Placa Aterosclerótica , Índice de Severidad de la Enfermedad
15.
Atherosclerosis ; 229(2): 443-8, 2013 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-23880201

RESUMEN

Chest pain associated with cocaine use represents an increasing problem in the emergency department (ED). Cocaine use has been linked to the acute coronary syndrome (ACS) and acute myocardial infarction (AMI). We used coronary computed tomography angiography (cCTA) to evaluate the prevalence, severity and composition of atherosclerotic lesions in cocaine users. We studied 78 patients with non-occasional cocaine use (52 men, 44 ± 7 years, 23 under the acute influence) and acute chest pain but without ACS, who had undergone cCTA in the ED. Patients were matched one-to-one by gender, race, symptoms, and risk-factors with a control cohort (n = 78; 52 men, 45 ± 6 years) not using cocaine. Each coronary segment was evaluated for the presence and composition (calcified, non-calcified, partially calcified) of atherosclerotic plaque and for stenosis. The prevalence of coronary stenosis was not significantly different between patients with and without cocaine use (13% versus 5%, P > 0.05). However, cocaine users on average had significantly more atherosclerotic plaques (0.44 ± 0.88 versus 0.29 ± 0.83, P < 0.05) and a tendency towards more calcified (0.64 ± 1.23 versus 0.55 ± 1.22, P > 0.05) and non-calcified plaques (0.26 ± 0.63 versus 0.17 ± 0.57, P > 0.05), yet not reaching statistical significance. Furthermore, cocaine users had significantly more partially calcified plaques (0.41 ± 0.61 versus 0.17 ± 0.41, P < 0.05) and higher partially calcified plaque volume (59.7 ± 33.3 mm(3) versus 25.6 ± 12.6 mm(3), P < 0.05). Thus, cocaine users tend to have more pronounced coronary atherosclerosis compared to patients without cocaine use at the time of presentation with acute chest pain.


Asunto(s)
Trastornos Relacionados con Cocaína/epidemiología , Estenosis Coronaria/diagnóstico por imagen , Estenosis Coronaria/epidemiología , Placa Aterosclerótica/diagnóstico por imagen , Placa Aterosclerótica/epidemiología , Tomografía Computarizada por Rayos X , Dolor Agudo/epidemiología , Adulto , Negro o Afroamericano/estadística & datos numéricos , Dolor en el Pecho/epidemiología , Femenino , Humanos , Masculino , Análisis por Apareamiento , Persona de Mediana Edad , Prevalencia , Estudios Retrospectivos , Factores de Riesgo , Índice de Severidad de la Enfermedad , Población Blanca/estadística & datos numéricos
16.
Radiology ; 269(2): 378-86, 2013 Nov.
Artículo en Inglés | MEDLINE | ID: mdl-23788717

RESUMEN

PURPOSE: To determine the diagnostic accuracy of dynamic computed tomographic (CT) perfusion imaging of the myocardium for the detection of hemodynamically relevant coronary artery stenosis compared with the accuracy of coronary angiography and fractional flow reserve (FFR) measurement. MATERIALS AND METHODS: This study was approved by the institutional review board and the Federal Radiation Safety Council (Bundesamt für Strahlenschutz). All patients provided written informed consent. Thirty-two consecutive patients in adenosine stress conditions underwent dynamic CT perfusion imaging (14 consecutive data sets) performed by using a 256-section scanner with an 8-cm detector and without table movement. Time to peak, area under the curve, upslope, and peak enhancement were determined after calculation of time-attenuation curves. In addition, myocardial blood flow (MBF) was determined quantitatively. Results were compared with those of coronary angiography and FFR measurement by using a receiver operating characteristic (ROC) analysis. In addition, threshold values based on the Youden index and sensitivity and specificity were calculated. RESULTS: Area under the ROC curve, sensitivity, and specificity, respectively, were 0.67, 41.4% (95% confidence interval [CI]: 23.5%, 61.1%), and 86.6% (95% CI: 76.0%, 93.7%) for time to peak; 0.74, 58.6% (95% CI: 38.9%, 76.5%), and 83.6% (95% CI: 72.5%, 91.5%) for area under the curve; 0.87, 82.8% (95% CI: 64.2%, 94.1%), and 88.1% (95% CI: 77.8%, 94.7%) for upslope; 0.83, 82.8% (95% CI: 64.2%, 94.1%), and 89.6% (95% CI: 79.6%, 95.7%) for peak enhancement; and 0.86, 75.9% (95% CI: 56.5%, 89.7%), and 100% (95% CI: 94.6%, 100%) for MBF. The thresholds determined by using the Youden index were 148.5 HU · sec for area under the curve, 12 seconds for time to peak, 2.5 HU/sec for upslope, 34 HU for peak enhancement, and 1.64 mL/g/min for MBF. CONCLUSION: The semiquantitative parameters upslope and peak enhancement and the quantitative parameter MBF showed similar high diagnostic accuracy. SUPPLEMENTAL MATERIAL: http://radiology.rsna.org/lookup/suppl/doi:10.1148/radiol.13121441/-/DC1.


Asunto(s)
Estenosis Coronaria/diagnóstico por imagen , Tomografía Computarizada por Rayos X/métodos , Anciano , Comorbilidad , Medios de Contraste , Angiografía Coronaria , Prueba de Esfuerzo , Femenino , Reserva del Flujo Fraccional Miocárdico , Humanos , Yopamidol/análogos & derivados , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Interpretación de Imagen Radiográfica Asistida por Computador , Factores de Riesgo , Sensibilidad y Especificidad
17.
J Cardiovasc Magn Reson ; 15: 30, 2013 Apr 10.
Artículo en Inglés | MEDLINE | ID: mdl-23574690

RESUMEN

BACKGROUND: Recent studies have demonstrated a superior diagnostic accuracy of cardiovascular magnetic resonance (CMR) for the detection of coronary artery disease (CAD). We aimed to determine the comparative cost-effectiveness of CMR versus single-photon emission computed tomography (SPECT). METHODS: Based on Bayes' theorem, a mathematical model was developed to compare the cost-effectiveness and utility of CMR with SPECT in patients with suspected CAD. Invasive coronary angiography served as the standard of reference. Effectiveness was defined as the accurate detection of CAD, and utility as the number of quality-adjusted life-years (QALYs) gained. Model input parameters were derived from the literature, and the cost analysis was conducted from a German health care payer's perspective. Extensive sensitivity analyses were performed. RESULTS: Reimbursement fees represented only a minor fraction of the total costs incurred by a diagnostic strategy. Increases in the prevalence of CAD were generally associated with improved cost-effectiveness and decreased costs per utility unit (ΔQALY). By comparison, CMR was consistently more cost-effective than SPECT, and showed lower costs per QALY gained. Given a CAD prevalence of 0.50, CMR was associated with total costs of €6,120 for one patient correctly diagnosed as having CAD and with €2,246 per ΔQALY gained versus €7,065 and €2,931 for SPECT, respectively. Above a threshold value of CAD prevalence of 0.60, proceeding directly to invasive angiography was the most cost-effective approach. CONCLUSIONS: In patients with low to intermediate CAD probabilities, CMR is more cost-effective than SPECT. Moreover, lower costs per utility unit indicate a superior clinical utility of CMR.


Asunto(s)
Enfermedad de la Arteria Coronaria/diagnóstico , Enfermedad de la Arteria Coronaria/economía , Imagen por Resonancia Magnética/economía , Tomografía Computarizada de Emisión de Fotón Único/economía , Teorema de Bayes , Angiografía Coronaria , Análisis Costo-Beneficio , Alemania , Humanos , Años de Vida Ajustados por Calidad de Vida
18.
Clin Cardiol ; 36(7): 407-13, 2013 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-23595957

RESUMEN

BACKGROUND: The economic impact of drug-eluting stent (DES) in-stent restenosis (ISR) is substantial, highlighting the need for cost-effective treatment strategies. HYPOTHESIS: Compared to plain old balloon angioplasty (POBA) or repeat DES implantation, drug-coated balloon (DCB) angioplasty is a cost-effective therapy for DES-ISR. METHODS: A Markov state-transition model was used to compare DCB angioplasty with POBA and repeat DES implantation. Model input parameters were obtained from the literature, and the cost analysis was conducted from a German healthcare payer's perspective. Extensive sensitivity analyses were performed. RESULTS: Initial procedure costs amounted to €3488 for DCB angioplasty and to €2782 for POBA. Over a 6-month time horizon, the DCB strategy was less costly (€4028 vs €4169) and more effective in terms of life-years (LYs) gained (0.497 versus 0.489) than POBA. The DES strategy incurred initial costs of €3167 and resulted in 0.494 LYs gained, at total costs of €4101 after a 6-month follow-up. Thus, DCB angioplasty was the least costly and most effective strategy. Base-case results were influenced mostly by initial procedure costs, target lesion revascularization rates, and the costs of dual antiplatelet therapy. CONCLUSIONS: DCB angioplasty is a cost-effective treatment option for coronary DES-ISR. The higher initial costs of the DCB strategy compared to POBA or repeat DES implantation are offset by later cost savings.


Asunto(s)
Angioplastia Coronaria con Balón/economía , Angioplastia Coronaria con Balón/instrumentación , Catéteres Cardíacos/economía , Fármacos Cardiovasculares/economía , Materiales Biocompatibles Revestidos/economía , Reestenosis Coronaria/economía , Reestenosis Coronaria/terapia , Portadores de Fármacos/economía , Stents Liberadores de Fármacos/economía , Costos de la Atención en Salud , Paclitaxel/economía , Angioplastia Coronaria con Balón/efectos adversos , Fármacos Cardiovasculares/administración & dosificación , Reestenosis Coronaria/etiología , Ahorro de Costo , Análisis Costo-Beneficio , Costos de los Medicamentos , Alemania , Humanos , Cadenas de Markov , Modelos Económicos , Método de Montecarlo , Paclitaxel/administración & dosificación , Inhibidores de Agregación Plaquetaria/economía , Inhibidores de Agregación Plaquetaria/uso terapéutico , Años de Vida Ajustados por Calidad de Vida , Factores de Tiempo , Resultado del Tratamiento
19.
Clin Res Cardiol ; 102(8): 555-62, 2013 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-23584714

RESUMEN

INTRODUCTION: Pericardial adipose tissue (PAT), a visceral fat depot surrounding the heart, serves as an endocrine active organ and is associated with inflammation. There is growing evidence that atrial fibrillation (AF) is linked with inflammation, which in turn can be a promoter of left atrial remodeling. The aim of this study was to evaluate a potential correlation of PAT to AF and left atrial structural remodeling represented by LA size. METHODS: PAT was measured in 1,288 patients who underwent coronary artery calcium-scanning for coronary risk stratification. LA size was determined by two independent readers. Patients were subdivided into patients without AF, patients with paroxysmal and persistent AF. RESULTS: PAT was independently correlated with AF, persistent AF, and LA size (all p values <0.001). No association could be observed between paroxysmal AF and PAT. These associations persisted after multivariate adjustment for AF risk factors such as age, hypertension, valvular disease, heart failure, and body mass index (AF: OR 1.52, 95 % CI 1.15-2.00, p = 0.003; persistent AF: OR 2.58, 95 % CI 1.69-3.99, p = 0.001; LA size: regression coefficient 0.15 with 95 % CI 0.10-0.20, p < 0.001). CONCLUSION: PAT is associated with AF, in particular with persistent AF and LA size. These findings suggest that PAT could be an independent risk factor for the development of AF and for LA remodeling.


Asunto(s)
Tejido Adiposo/patología , Fibrilación Atrial/fisiopatología , Atrios Cardíacos/patología , Pericardio/patología , Adulto , Anciano , Anciano de 80 o más Años , Remodelación Atrial , Femenino , Humanos , Inflamación/patología , Masculino , Persona de Mediana Edad , Análisis Multivariante , Estudios Retrospectivos , Factores de Riesgo , Adulto Joven
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