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Dolor en el Pecho , Humanos , Dolor en el Pecho/diagnóstico , Dolor en el Pecho/clasificación , Dolor en el Pecho/etiología , Terminología como Asunto , Alemania , Guías de Práctica Clínica como Asunto , Diagnóstico Diferencial , Síndrome Coronario Agudo/diagnóstico , Síndrome Coronario Agudo/clasificación , Cardiología/normasRESUMEN
Chest pain poses a diagnostic challenge in the emergency department and requires a thorough clinical assessment. The traditional distinction between "atypical" and "typical" chest pain carries the risk of not addressing nonischemic clinical pictures. The newly conceived subdivision into cardiac, possibly cardiac, and (probably) noncardiac causes of the presenting symptom complex addresses a much more interdisciplinary approach to a symptom-oriented diagnostic algorithm. The diagnostic structures of the chest pain units in Germany do not currently reflect this. An adaptation should therefore be considered.
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Dolor en el Pecho , Humanos , Dolor en el Pecho/clasificación , Dolor en el Pecho/etiología , Dolor en el Pecho/diagnóstico , Diagnóstico Diferencial , AlemaniaRESUMEN
BACKGROUND: Current guidelines emphasize the diagnostic value of non-cardiac or possibly cardiac chest pain. The goal of this analysis was to determine whether German chest pain units (CPUs) adequately address conditions with "atypical" chest pain in existing diagnostic structures. METHOD: A total of 11,734 patients from the German CPU registry were included. The analyses included mode of admission, critical time intervals, diagnostic steps, and differential diagnoses. RESULTS: Patients with unspecified chest pain were younger, more often female, were less likely to have classic cardiovascular risk factors and tended to present more often as self-referrals. Patients with acute coronary syndrome (ACS) mostly had prehospital medical contact. Overall, there was no difference between these two groups regarding the time from the onset of first symptoms to arrival at the CPU. In the CPU, the usual basic diagnostic measures were performed irrespective of ACS as the primary working diagnosis. In the non-ACS group, further ischemia-specific diagnostics were rarely performed. Extra-cardiac differential diagnoses were not specified. CONCLUSION: The establishment of broader awareness programs and opening CPUs for low-threshold evaluation of self-referring patients should be discussed. Regarding the rigid focus on the clarification of cardiac causes of chest pain, a stronger interdisciplinary approach should be promoted.
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Dolor en el Pecho , Anciano , Femenino , Humanos , Masculino , Persona de Mediana Edad , Síndrome Coronario Agudo/diagnóstico , Síndrome Coronario Agudo/epidemiología , Síndrome Coronario Agudo/complicaciones , Distribución por Edad , Dolor en el Pecho/etiología , Dolor en el Pecho/diagnóstico , Comorbilidad , Diagnóstico Diferencial , Alemania , Prevalencia , Sistema de Registros , Distribución por Sexo , Estudios RetrospectivosRESUMEN
BACKGROUND: ChatGPT is a 175-billion-parameter natural language processing model that is already involved in scientific content and publications. Its influence ranges from providing quick access to information on medical topics, assisting in generating medical and scientific articles and papers, performing medical data analyses, and even interpreting complex data sets. OBJECTIVE: The future role of ChatGPT remains uncertain and a matter of debate already shortly after its release. This review aimed to analyze the role of ChatGPT in the medical literature during the first 3 months after its release. METHODS: We performed a concise review of literature published in PubMed from December 1, 2022, to March 31, 2023. To find all publications related to ChatGPT or considering ChatGPT, the search term was kept simple ("ChatGPT" in AllFields). All publications available as full text in German or English were included. All accessible publications were evaluated according to specifications by the author team (eg, impact factor, publication modus, article type, publication speed, and type of ChatGPT integration or content). The conclusions of the articles were used for later SWOT (strengths, weaknesses, opportunities, and threats) analysis. All data were analyzed on a descriptive basis. RESULTS: Of 178 studies in total, 160 met the inclusion criteria and were evaluated. The average impact factor was 4.423 (range 0-96.216), and the average publication speed was 16 (range 0-83) days. Among the articles, there were 77 editorials (48,1%), 43 essays (26.9%), 21 studies (13.1%), 6 reviews (3.8%), 6 case reports (3.8%), 6 news (3.8%), and 1 meta-analysis (0.6%). Of those, 54.4% (n=87) were published as open access, with 5% (n=8) provided on preprint servers. Over 400 quotes with information on strengths, weaknesses, opportunities, and threats were detected. By far, most (n=142, 34.8%) were related to weaknesses. ChatGPT excels in its ability to express ideas clearly and formulate general contexts comprehensibly. It performs so well that even experts in the field have difficulty identifying abstracts generated by ChatGPT. However, the time-limited scope and the need for corrections by experts were mentioned as weaknesses and threats of ChatGPT. Opportunities include assistance in formulating medical issues for nonnative English speakers, as well as the possibility of timely participation in the development of such artificial intelligence tools since it is in its early stages and can therefore still be influenced. CONCLUSIONS: Artificial intelligence tools such as ChatGPT are already part of the medical publishing landscape. Despite their apparent opportunities, policies and guidelines must be implemented to ensure benefits in education, clinical practice, and research and protect against threats such as scientific misconduct, plagiarism, and inaccuracy.
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Inteligencia Artificial , Análisis de Datos , Humanos , Escolaridad , Lenguaje , Procesamiento de Lenguaje NaturalRESUMEN
BACKGROUND: Medical emergencies are complex and stressful, especially for the young and inexperienced. Cognitive aids (CA) have been shown to facilitate management of simulated medical emergencies by experienced teams. In this randomized trial we evaluated guideline adherence and treatment efficacy in simulated medical emergencies managed by residents with and without CA. METHODS: Physicians attending educational courses executed simulated medical emergencies. Teams were randomly assigned to manage emergencies with or without CA. Primary outcome was risk reduction of essential working steps. Secondary outcomes included prior experience in emergency medicine and CA, perceptions of usefulness, clinical relevance, acceptability, and accuracy in CA selection. Participants were grouped as "medical" (internal medicine and neurology) and "perioperative" (anesthesia and surgery) regarding their specialty. The study was designed as a prospective randomized single-blind study that was approved by the ethical committee of the University Duisburg-Essen (19-8966-BO). TRIAL REGISTRATION: DRKS, DRKS00024781. Registered 16 March 2021-Retrospectively registered, http://www.drks.de/DRKS00024781 . RESULTS: Eighty teams participated in 240 simulated medical emergencies. Cognitive aid usage led to 9% absolute and 15% relative risk reduction. Per protocol analysis showed 17% absolute and 28% relative risk reduction. Wrong CA were used in 4%. Cognitive aids were judged as helpful by 94% of the participants. Teams performed significantly better when emergency CA were available (p < 0.05 for successful completion of critical work steps). Stress reduction using CA was more likely in "medical" than in "perioperative" subspecialties (3.7 ± 1.2 vs. 2.9 ± 1.2, p < 0.05). CONCLUSIONS: In a high-fidelity simulation study, CA usage was associated with significant reduction of incorrect working steps in medical emergencies management and was characterized by high acceptance. These findings suggest that CA for medical emergencies may have the potential to improve emergency care.
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Anestesiología , Urgencias Médicas , Anestesiología/educación , Cognición , Humanos , Estudios Prospectivos , Método Simple CiegoRESUMEN
BACKGROUND: Little is known about importance and implementation of end-of-life care (EOLC) in German intensive care units (ICU). This survey analyses preferences and differences in training between "medical" (internal medicine, neurology) and "surgical" (surgery, anaesthesiology) residents during intensive care rotation. METHODS: This is a point-prevalence study, in which intensive care medicine course participants of one educational course were surveyed. Physicians from multiple ICU and university as well as non-university hospitals and all care levels were asked to participate. The questionnaire was composed of a paper and an electronic part. Demographic and structural data were prompted and EOLC data (48 questions) were grouped into six categories considering importance and implementation: category 1 (important, always implemented), 2 (important, sometimes implemented), 3 (important, never implemented) and 4-6 (unimportant, implementation always, sometimes, never). The trial is registered at the "Deutsches Register für klinische Studien (DRKS)", Study number DRKS00026619, registered on September 10th 2021, www.drks.de . RESULTS: Overall, 194/ 220 (88%) participants responded. Mean age was 29.7 years, 55% were female and 60% had scant ICU working experience. There were 64% medical and 35% surgical residents. Level of care and size of ICU differed significantly between medical and surgical (both p < 0.001). Sufficient implementation was stated for 66% of EOLC questions, room for improvement (category 2 and 3) was seen in 25, and 8% were classified as irrelevant (category 6). Areas with the most potential for improvement included prognosis and outcome and patient autonomy. There were no significant differences between medical and surgical residents. CONCLUSIONS: Even though EOLC is predominantly regarded as sufficiently implemented in German ICU of all specialties, our survey unveiled still 25% room for improvement for medical as well as surgical ICU residents. This is important, as areas of improvement potential may be addressed with reasonable effort, like individualizing EOLC procedures or setting up EOLC teams. Health care providers as well as medical societies should emphasize EOLC training in their curricula.
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Médicos , Cuidado Terminal , Adulto , Cuidados Críticos , Femenino , Humanos , Unidades de Cuidados Intensivos , Masculino , Encuestas y Cuestionarios , Cuidado Terminal/métodosRESUMEN
BACKGROUND: We aimed to analyze the 2020 standard of care in certified German chest pain units (CPU) with a special focus on non-ST-segment elevation acute coronary syndrome (NSTE-ACS) through a voluntary survey obtained from all certified units, using a prespecified questionnaire. METHODS: The assessment included the collection of information on diagnostic protocols, risk assessment, management and treatment strategies in suspected NSTE-ACS, the timing of invasive therapy in non-ST-segment elevation myocardial infarction (NSTEMI), and the choice of antiplatelet therapy. RESULTS: The response rate was 75%. Among all CPUs, 77% are currently using the European Society of Cardiology (ESC) 0/3h high-sensitive troponin protocol, and only 20% use the ESC 0/1h high-sensitive troponin protocol as a default strategy. Conventional ergometry is still the commonly performed stress test with a utilization rate of 47%. Among NSTEMI patients, coronary angiography is planned within 24â¯h in 96% of all CPUs, irrespective of the day of the week. Prasugrel is the P2Y12 inhibitor of choice in ST-segment elevation myocardial infarction (STEMI), but despite the impact of the ISAR-REACT 5 trial on selection of antiplatelet therapy, ticagrelor is still favored over prasugrel in NSTE-ACS. If triple therapy is used in NSTE-ACS with atrial fibrillation, it is maintained up to 4 weeks in 51% of these patients. CONCLUSION: This survey provides evidence that Germany's certified CPUs ensure a high level of guideline adherence and quality of care. The survey also identified areas in need of improvement such as the high utilization rate of stress electrocardiogram (ECG).
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Síndrome Coronario Agudo , Cardiología , Infarto del Miocardio sin Elevación del ST , Infarto del Miocardio con Elevación del ST , Humanos , Síndrome Coronario Agudo/diagnóstico , Síndrome Coronario Agudo/terapia , Infarto del Miocardio sin Elevación del ST/terapia , Infarto del Miocardio sin Elevación del ST/tratamiento farmacológico , Inhibidores de Agregación Plaquetaria/uso terapéutico , Pautas de la Práctica en Medicina , Clorhidrato de Prasugrel , Dolor en el Pecho/diagnóstico , Troponina , Infarto del Miocardio con Elevación del ST/tratamiento farmacológico , Encuestas y Cuestionarios , AlemaniaRESUMEN
AIMS: Early heart attack awareness programs are thought to increase efficacy of chest pain units (CPU) by providing live-saving information to the community. We hypothesized that self-referral might be a feasible alternative to activation of emergency medical services (EMS) in selected chest pain patients with a specific low-risk profile. METHODS AND RESULTS: In this observational registry-based study, data from 4743 CPU patients were analyzed for differences between those with or without severe or fatal prehospital or in-unit events (out-of-hospital cardiac arrest and/or in-unit death, resuscitation or ventricular tachycardia). In order to identify a low-risk subset in which early self-referral might be recommended to reduce prehospital critical time intervals, the Global Registry of Acute Coronary Events (GRACE) score for in-hospital mortality and a specific low-risk CPU score developed from the data by multivariate regression analysis were applied and corresponding event rates were calculated. Male gender, cardiac symptoms other than chest pain, first onset of symptoms and a history of myocardial infarction, heart failure or cardioverter defibrillator implantation increased propensity for critical events. Event rates within the low-risk subsets varied from 0.5-2.8%. Those patients with preinfarction angina experienced fewer events. CONCLUSIONS: When educating patients and the general population about angina pectoris symptoms and early admission, activation of EMS remains recommended. Even in patients without any CPU-specific risk factor, self-referral bears the risk of severe or fatal pre- or in-unit events of 0.6%. However, admission should not be delayed, and self-referral might be feasible in patients with previous symptoms of preinfarction angina.
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Servicios Médicos de Urgencia , Infarto del Miocardio , Angina Inestable , Dolor en el Pecho/diagnóstico , Dolor en el Pecho/epidemiología , Dolor en el Pecho/terapia , Electrocardiografía , Humanos , Masculino , Infarto del Miocardio/diagnóstico , Infarto del Miocardio/epidemiología , Infarto del Miocardio/terapiaRESUMEN
INTRODUCTION: Since 2008, specialized chest pain units (CPUs) were implemented across Germany ensuring structured diagnostics in acute chest pain. This study aims to analyze the management of pulmonary embolism (PE) patients in such certified CPUs. METHODS: Data were retrieved from 13,902 patients enrolled in the German CPU registry and analyzed for the diagnosis of PE including patient characteristics, critical time intervals, diagnostic workup, treatment, and prognosis. PE patients were compared to the overall CPU patient cohort. Only patients with a complete 3-month follow-up were included. RESULTS: Overall, 1.1% of all CPU patients were diagnosed with PE. Chest pain and dyspnea were the leading symptoms. Patients with PE were older, presented with higher heart rates, and more frequently exhibited signs of heart failure, despite a normal left ventricular function. PE patients showed significantly longer time delays between symptom onset and the first medical contact, while PE patients with chest pain presented earlier than PE patients with dyspnea only. Whereas more PE patients had to be transferred to the intensive care unit, in-CPU mortality and event rates over 3 months were low. DISCUSSION/CONCLUSION: This study suggests a certain risk for underdiagnosis and consecutive potential undertreatment of PE patients in German Cardiac Society (GCS)-certified CPUs, which is thought to result from an anticipated focus on patients with acute coronary syndrome (ACS). Public awareness for PE beyond chest pain should be improved. Certified CPUs should be urged to implement strategic pathways for a better simultaneous diagnostic workup of differential diagnosis beyond ACS.
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Síndrome Coronario Agudo , Embolia Pulmonar , Dolor en el Pecho/diagnóstico , Dolor en el Pecho/epidemiología , Dolor en el Pecho/etiología , Alemania/epidemiología , Humanos , Embolia Pulmonar/diagnóstico , Embolia Pulmonar/epidemiología , Embolia Pulmonar/terapia , Sistema de RegistrosRESUMEN
BACKGROUND: Chest pain units (CPUs) and stroke units (SUs) provide specialized multidisciplinary in-hospital management for acute chest pain and ischemic stroke. We analyzed exemplary equivalent quality benchmarks in both concepts. MATERIAL AND METHODS: Data from the German CPU registry (2012-2015; 45 certified CPUs, 5881 patients) were compared with data from the SU registry of Rhineland-Palatinate (2011-2015; 29 SUs; 40,380 patients). Parameters comprised demographics, symptoms, diagnosis, medication, critical time intervals, therapeutics, and in-unit outcome. RESULTS: Non-ST-segment elevation myocardial infarction (47.4%) and ischemic stroke (63.0%) were the most frequent entities. An electrocardiogram was performed on average within 7â¯min in CPUs, cranial imaging within 49â¯min in SUs. The mean time interval from admission until coronary intervention or lysis was 42â¯min or 57â¯min, respectively. Rates of antiplatelet therapy (90.1% vs. 96.0%), brain imaging, and coronary angiography were high (99.3% vs. 81.1%) and the mortality was low (0.8% for CPUs vs. 3.6% for SUs). The length of stay was shorter in CPUs (1.5 days vs. 4.4 days). CONCLUSION: As reimbursement for emergency medicine in Germany was recently rearranged, quality benchmarking has gained incremental importance. Mandatory joint quality measurement in both concepts ensuring gap analysis and process improvement is encouraged.
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Infarto del Miocardio sin Elevación del ST , Accidente Cerebrovascular , Benchmarking , Dolor en el Pecho/diagnóstico , Dolor en el Pecho/terapia , Alemania/epidemiología , Humanos , Accidente Cerebrovascular/diagnóstico , Accidente Cerebrovascular/terapiaRESUMEN
In 2008, the German Cardiac Society (GCS) introduced a certification program for specialized chest pain units (CPUs). In order to benchmark the performance of the certified CPUs, a nationwide German CPU registry was established. Since then, data for more than 34,000 patients have been included. The concept of certified CPUs in Germany has been widely accepted and its success is underlined by its recent inclusion in national and international guidelines. As of December 2019, 286 CPUs have been successfully certified or recertified by the GCS. This review focuses on the data retrieved from the CPU registry during the first decade of certification. As demonstrated by 16 manuscripts stemming from the registry, certified German CPUs demonstrate high quality of care in acute coronary syndrome and beyond. It is also noted that the German CPU registry allowed for further analysis of the gap in guideline adherence. With the current update of the CPU certification criteria, central data collection as a best-practice criterion will be abandoned, and after some productive years the registry has temporarily been stopped.
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Dolor en el Pecho , Unidades Hospitalarias , Certificación , Dolor en el Pecho/diagnóstico , Dolor en el Pecho/epidemiología , Dolor en el Pecho/terapia , Alemania/epidemiología , Humanos , Sistema de RegistrosRESUMEN
Background: Endovascular venous stenting with dedicated venous stents for the treatment of chronic venous outflow obstruction is developing as efficacious alternative to conservative therapy or open surgery. However, so far, mid- and long-term evidence on effectiveness and safety is poor. Patients and methods: The prospective, single-center, observational study enrolled consecutive patients with chronic non-thrombotic iliac vein lesions (NIVL) or post-thrombotic iliofemoral obstructions (PTO). From February 2016 to April 2017, patients underwent implantation of open cell, self-expandable dedicated venous stents. Short-term symptomatic improvement, patency, and complication rate were favorable. Evaluation at 2-years included improvement in the revised venous clinical severity score (rVCSS), patency, stent migration, major target limb events, clinically important pulmonary embolism, major bleeding, and all-cause mortality. Results: A total of 79 patients (57 ± 16 years, 44 female) were evaluated. At 2 years, rVCCS improved by 4.3 ± 2.7 (p < 0.001). Substantial clinical improvement of ≥ 2 score points was achieved in 86.4% (38 of 44) of patients. Improvement was not associated with thrombotic pathogenesis (regression coefficient [B] with PTO = 0.6 [95%CI: -1.1 to 2.3], p = 0.48). At 2 years, all ulcers (in 8 of 79 patients) were healed and none recurred. Two-year primary patency was 95.5% (95%CI: 86.5 to 98.5) with no difference between NIVL- and PTO-patients (log-rank p = 0.83). Target vessel revascularization was conducted in two PTO- and one NIVL-patients in the period of 34 days to 156 days from index procedure, resulting in a secondary patency of 100%. No stent migration, target limb deep vein thrombosis, major amputation, pulmonary embolism, or death occurred. Conclusions: Venovo venous open cell self-expanding stent implantation for chronic outflow obstruction was efficacious and provided a sufficient level of safety throughout 2 years.
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Procedimientos Endovasculares/métodos , Vena Ilíaca/cirugía , Síndrome de May-Thurner/cirugía , Stents , Adulto , Anciano , Enfermedad Crónica , Femenino , Alemania , Humanos , Vena Ilíaca/diagnóstico por imagen , Síndrome de May-Thurner/diagnóstico por imagen , Persona de Mediana Edad , Estudios Prospectivos , Sistema de Registros , Resultado del Tratamiento , Grado de Desobstrucción VascularRESUMEN
BACKGROUND: Chest pain units (CPU) and stroke units (SU) have both become established as essential components of clinical emergency care. For both instances dedicated certification processes are installed. Up to summer 2020, 290 CPUs and 335 SUs have been successfully certified. OBJECTIVE: The aim of this review is to compare the structures and the current certification situation of CPUs and SUs. Also, the younger CPU certification process is compared to the long established SU certification standard. MATERIAL UND METHODS: The comparison includes the historical background, the certification process, quality benchmarking, possible additive structures, the current status of certification in Germany, the transfer of the concept to the European level as well as reimbursement issues. RESULTS: Both certification concepts show clear analogies. Evidence for SUs is supported by a positive Cochrane analysis and for CPUs there are many studies from the German CPU registry. The main differences include a uniform CPU system versus a multistep SU system of certification. Furthermore, SU have obligatory elements of quality documentation but only facultative quality indicator assessment for CPUs. From an economic viewpoint operation and procedural key (OPS) numbers guarantee a better reflection of the use of resources in the complex treatment of stroke, which could not yet be established for CPUs. CONCLUSION: The well-established CPU concept could additionally benefit from a superordinate quality control. Adequate quality benchmarking appears to be fundamental for gap analyses and for the establishment of a separate remuneration structure. In this respect the German Society for Cardiology as the certifying institution is required to establish an appropriate mechanism within the framework of regular updates of criteria.
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Servicios Médicos de Urgencia , Accidente Cerebrovascular , Benchmarking , Certificación , Dolor en el Pecho/diagnóstico , Dolor en el Pecho/terapia , Alemania , Humanos , Accidente Cerebrovascular/diagnóstico , Accidente Cerebrovascular/terapiaRESUMEN
INTRODUCTION: Gender-specific atypical clinical presentation in acute coronary syndrome and sex-specific outcomes in cardiovascular disease in women are well known. The aim of this study is to analyze possible differences between men and women presenting to certified German chest pain units (CPUs). METHODS: Data from 13,900 patients derived from the German CPU registry were analyzed for gender differences in patient characteristics, cardiovascular disease manifestation, critical time intervals, treatment and prognosis. RESULTS: A total of 37.8% of patients were female. Typical chest pain occurred more frequently in men, while atypical symptoms occurred more frequently in women. Female gender was associated with longer pre- and in-hospital time delays. Women were more often diagnosed with a nonischemic origin of pain. In a 3-month follow-up, there was no gender-specific difference in combined major adverse coronary and cerebrovascular events. DISCUSSION/CONCLUSION: This study points out gender-specific differences in prehospital time intervals and a significantly higher percentage of atypical symptoms in suspected myocardial ischemia as well as more noncoronary diagnoses in women. Symptom awareness and a broader diagnostic workup in women are essential.
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Síndrome Coronario Agudo , Dolor en el Pecho/epidemiología , Admisión del Paciente/estadística & datos numéricos , Sistema de Registros , Anciano , Anciano de 80 o más Años , Femenino , Alemania/epidemiología , Humanos , Masculino , Persona de Mediana Edad , Factores de Riesgo , Distribución por Sexo , Factores SexualesRESUMEN
BACKGROUND: We sought to determine structure and changes in organisation and bed capacities of certified German chest pain units (CPU) in response to the emergency plan set-up as a response to the SARS-CoV-2 pandemic. METHODS AND RESULTS: The study was conducted in the form of a standardised telephone interview survey in certified German CPUs. Analyses comprised the overall setting of the CPU, bed capacities, possibilities for ventilation, possible changes in organisation and resources, chest pain patient admittance, overall availability of CPUs and bail-out strategies. The response rate was 91%. Nationwide, CPU bed capacities decreased by 3% in the early phase of COVID-19 pandemic response, exhibiting differences within and between the federal states. Pre-pandemic and pandemic bed capacities stayed below 1 CPU bed per 50,000 inhabitants. 97% of CPUs were affected by internal reorganisation pandemic plans at variable extent. While we observed a decrease of CPU beds within an emergency room (ER) set-up and on intermediate care units (ICU), beds in units being separated from ER and ICU were even increased in numbers. CONCLUSIONS: Certified German CPUs are able to maintain adequate coverage for chest pain patients in COVID-19 pandemic despite structural changes. However, at this time, it appears important to add operating procedures during pandemic outbreaks to the certification criteria of forthcoming guidelines either at the individual CPU level or more centrally steered by the German Cardiac Society or the European Society of Cardiology.
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COVID-19/terapia , Servicio de Cardiología en Hospital/organización & administración , Dolor en el Pecho/terapia , Servicio de Urgencia en Hospital/organización & administración , Necesidades y Demandas de Servicios de Salud/organización & administración , Capacidad de Camas en Hospitales , Hospitalización , Unidades de Cuidados Intensivos/organización & administración , COVID-19/diagnóstico , COVID-19/epidemiología , Dolor en el Pecho/diagnóstico , Dolor en el Pecho/epidemiología , Alemania/epidemiología , Encuestas de Atención de la Salud , Humanos , Evaluación de NecesidadesRESUMEN
Purpose: To assess the practical application and acute outcomes of the Tack Endovascular System for infrainguinal dissection repair in a real-world setting. Materials and Methods: Fifty-one consecutive patients who underwent endovascular revascularization for symptomatic peripheral artery disease and experienced 63 dissections requiring treatment were included in the prospective, single-center, single-arm study between January and June 2019. Thirty-nine (76.5%) lesions were ≥10 cm in length, 33 (64.7%) were totally occluded, and 13 (25.5%) were severely calcified. Fifty-six (88.9%) dissections were classified as severe. Dissections were treated either by means of the 6-F above-the-knee (ATK) or the 4-F below-the-knee (BTK) Tack Endovascular System. Observational outcomes were conditions and scopes of application. Clinical outcomes were acute technical and procedural success as well as safety. Results: Lesions were revascularized with 2.3±0.8 attempts such as standard balloon angioplasty, drug-coated balloon angioplasty, atherectomy, and/or lithotripsy. The Endovascular System was applied in 60 (95.2%) of 63 dissections. All dissections of the femoral artery were treated with the ATK system, and all infrapopliteal dissections with the BTK system. Both systems were successfully applied in popliteal artery dissections. Dissection length predicted the number of Tack implants deployed. Technical success was achieved in 98.3% (59 of 60 dissections). No major adverse event or device-related complication occurred during the procedure. Conclusion: Acute results in effectiveness and safety of the Tack Endovascular System for infrainguinal dissection repair in a real-world setting are promising.
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Procedimientos Endovasculares/instrumentación , Arteria Femoral/lesiones , Enfermedad Arterial Periférica/terapia , Arteria Poplítea/lesiones , Prótesis e Implantes , Calcificación Vascular/terapia , Lesiones del Sistema Vascular/terapia , Aleaciones , Procedimientos Endovasculares/efectos adversos , Arteria Femoral/diagnóstico por imagen , Arteria Femoral/fisiopatología , Humanos , Enfermedad Arterial Periférica/diagnóstico por imagen , Enfermedad Arterial Periférica/fisiopatología , Arteria Poplítea/diagnóstico por imagen , Arteria Poplítea/fisiopatología , Estudios Prospectivos , Diseño de Prótesis , Índice de Severidad de la Enfermedad , Stents , Resultado del Tratamiento , Turquía , Calcificación Vascular/diagnóstico por imagen , Calcificación Vascular/fisiopatología , Grado de Desobstrucción Vascular , Lesiones del Sistema Vascular/diagnóstico por imagen , Lesiones del Sistema Vascular/etiología , Lesiones del Sistema Vascular/fisiopatologíaRESUMEN
Background: Previous studies showed favorable results after treatment of femoropopliteal lesions with the Pulsar-18 self-expanding (SE) nitinol stent. The objective of this registry was to evaluate whether these results will be confirmed in a real-world setting with varying stenting strategies. Patients and methods: In this prospective, observational trial, 160 patients with 186 femoropopliteal lesions were treated with the Pulsar-18 SE nitinol stent at 9 German sites. Mean lesion length was 116 ± 103 mm, and 41.9 % of the lesions were moderately or heavily calcified. Eighty lesions were concomitantly treated with drug-coated balloon (DCB). Main effectiveness outcome was primary patency at 12 months, and main safety outcome was freedom from the composite of device or procedure related death, major target limb amputation, and clinically driven target lesion revascularization (TLR) at 30 days and 6 months. Results: Kaplan-Meier estimate of primary patency was 89.1 %, 67.3 %, and 57.1 % at 6, 12, and 24 months. Freedom from TLR was 95.5 %, 91.4 %, and 85.2 % at 6, 12, and 24 months, respectively. Lesions, which were additionally treated with DCB (plus DCB-group), were longer (150 versus 82 mm on average, p < 0.0001), and associated with lower primary patency estimates than those without DCB angioplasty (stent-only-group) (log-rank p = 0.006). However, there was no difference in freedom from TLR between groups (log-rank p = 0.542). Improvement by ≥ 1 Rutherford category was achieved in 84.8 %, 81.0 %, and 81.7 % of patients at 6, 12, and 24 months, respectively. Walking distance and patient-reported pain improved persistently through 24 months (p < 0.001). Hemodynamic improvement was achieved in 68.2 %, 73.7 %, and 70.7 % of the patients at 6, 12, and 24 months, respectively. Conclusions: The Pulsar-18 self-expanding nitinol stent with optional drug-coated balloon angioplasty can be considered an efficacious and safe therapy option for endovascular treatment of femoropopliteal artery disease.
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Angioplastia de Balón , Enfermedad Arterial Periférica , DEAE Dextrano , Arteria Femoral , Humanos , Arteria Poplítea , Estudios Prospectivos , Sistema de Registros , Stents , Resultado del Tratamiento , Grado de Desobstrucción VascularRESUMEN
Background: Percutaneous mechanical thrombectomy (PMT) represents a treatment option in addition to conventional therapy for patients with iliofemoral deep vein thrombosis (DVT). We sought to determine the safety, patency and short-term outcome of the Aspirex®S catheter as a rotational mechanical thrombectomy device in the endovascular treatment of iliofemoral DVT. Patients and methods: 56 patients (66 % female, median age 51 years) undergoing mechanical thrombectomy with the Aspirex®S catheter for endovascular treatment of iliofemoral DVT were included in the analysis. Device- and procedure-related complications, prevention of post-thrombotic syndrome (PTS) and patency rates were determined at baseline and at 1, 6 and 12 months after intervention. Results: No device-related complications or malfunction occurred. Procedure-related complications (rehospitalization, re-occlusion of target vein, prolonged hospitalization resulting from access site complication) were seen in 14 % of patients. PMT was followed by implantation of a dedicated venous stent in all patients. Low PTS reflected by a revised venous clinical severity score (rVCSS) of < 3 and a clinical, etiologic, anatomic and pathophysiologic (CEAP) score of < 3 were achieved in 64 % of the patients at 12 months. Patency was 95 % after 1 month, 94 % after 6 months and 87 % after 12 months. Conclusions: Even though long-term studies are missing, PMT of iliofemoral DVT using the Aspirex®S rotational thrombectomy device as a standalone approach exhibited an excellent patency at short term associated with substantial prevention of moderate to severe PTS and low device-related complications including bleeding.
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Vena Ilíaca , Trombosis de la Vena , Femenino , Vena Femoral , Humanos , Masculino , Persona de Mediana Edad , Sistema de Registros , Trombectomía , Terapia Trombolítica , Resultado del TratamientoRESUMEN
Background: We sought to determine the patency and clinical symptom relief following the usage of the sinus-Obliquus venous stent in the endovascular treatment of venous obstruction of the ilio-femoral track in short-term. Patients and methods: 48 patients (62 % female, mean age 57 years) with chronic unilateral post-thrombotic obstruction (PTO) and non-thrombotic iliac vein obstructive lesions (NIVL) without involvement of inferior vena cava receiving a sinus-Obliquus venous stent was included in the analysis. Clinical improvement determined by the revised venous clinical severity score (rVCSS) as well as the clinical, etiologic, anatomic and pathophysiologic score (CEAP), safety, and stent patency rates were determined at baseline and at 1, 6 and 12 months after stent placement. Ten of the 48 included patients had a venous ulceration. Results: Primary patency rates were 98 % at FU1, 94 % at FU2 and 94 % at FU3, respectively. Secondary patency was 100 % at FU1, 96 % at FU2 and remained 96 % at FU3. At 12 months, the mean rVCSS dropped from 9.0 to 4.8 points (p < 0.001) whereas the mean CEAP improved from 3.45 to 2.96 (p < 0.001). A substantial healing of ulcerations was observed in 8 of 10 patients with initial venous ulceration. There were no relevant safety concerns noticed. Conclusions: Even though long-term studies are missing, the sinus-Obliquus venous stent already showed very promising patency rates at short term, associated with substantial clinical improvement and low device-related complications in both NIVL and PTS.