OBJECTIVE: This study aimed to evaluate the safety and performance of PowerPICC catheters in a real-world setting. DESIGN: Prospective, observational, multicentre study. SETTING: Nine European countries, involving 14 centres. PARTICIPANTS: General patient population. INTERVENTION: PowerPICC catheter inserted by the clinician as standard of care with routinely collected outcomes followed through device removal or 180 days postinsertion. PRIMARY AND SECONDARY OUTCOMES MEASURES: Safety and performance outcomes were assessed for PowerPICC, PowerPICC SOLO 2 and PowerGroshong PICC. The primary safety endpoint was the incidence of symptomatic venous thrombosis (VT), and secondary safety endpoints included phlebitis, extravasation, vessel laceration, vessel perforation local infection, accidental dislodgment and catheter-related bloodstream infection (CRBSI). The primary performance endpoint was the percentage of patients whose PowerPICC device remained in place through the completion of therapy. The secondary performance endpoints included catheter patency, placement success in a single attempt and usability. RESULTS: The enrolled patients (N=451) received either PowerPICC, PowerPICC SOLO 2 or PowerGroshong PICC catheters. Across all devices, 1.6% of patients developed symptomatic VT, and CRBSI occurred in 1.6% of patients. There were no cases of phlebitis or extravasation and only three cases of vein laceration or vein perforation. The catheters showed high success rates in completing therapy (81.8%), maintaining patency (93.9%) and achieving successful placement in a single attempt (90.4%). Clinicians overwhelmingly agreed that both the guidewire and stylet (93.3% and 94.4%, respectively) were easy or very easy to use. CONCLUSIONS: This study demonstrates the safety and performance of PowerPICC catheters across diverse settings and patient cohorts in real-world hospital settings across Europe. The findings indicate that these catheters are safe and can be effectively used in the general patient setting and when inserted by a variety of clinicians. The low incidence of complications and high success rates further support the clinical utility of these catheters. TRIAL REGISTRATION NUMBER: NCT04263649.
- MeSH
- centrální žilní katétry škodlivé účinky MeSH
- dospělí MeSH
- flebitida etiologie epidemiologie MeSH
- katetrizace centrálních vén škodlivé účinky přístrojové vybavení metody MeSH
- katétrové infekce * epidemiologie prevence a kontrola MeSH
- lidé středního věku MeSH
- lidé MeSH
- periferní katetrizace škodlivé účinky přístrojové vybavení MeSH
- prospektivní studie MeSH
- senioři MeSH
- zaváděcí katétry škodlivé účinky MeSH
- žilní trombóza epidemiologie etiologie prevence a kontrola MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
- pozorovací studie MeSH
- Geografické názvy
- Evropa MeSH
Cíl: Cílem této studie bylo měřit hodnoty D-dimeru a zjistit jejich vztah k hluboké žilní trombóze (HŽT) a mortalitě pacientů s onemocněním COVID-19. Metoda: Z populace přibližně 1 200 pacientů, u nichž se provádělo vyšetření HŽT obou dolních končetin dopplerovským ultrazvukem, byl vytvořen vzorek sestávající ze 100 pacientů s HŽT a 100 jedinců bez HŽT. Kromě pohlaví a věku účastníků se stanovovaly hodnoty D-dimeru v následujících intervalech > 20 μg/ml, 10 až 20 μg/ml, 5 až 10 μg/ml, 3 až 5 μg/ml a < 3 μg/ml. Sledoval se vztah mezi kategorií hodnot D-dimeru a mortalitou. Výsledky: Průměrné hodnoty D-dimeru ve skupinách s/bez HŽT byly 11,90, resp. 4,97 μg/ml; tento rozdíl byl statisticky významný (p = 0,0001, párový t test). Mortalita byla vyšší než 35 % u pacientů bez HŽT a s hodnotami D-dimeru > 3 μg/ml. Ve skupině s HŽT byla mortalita vyšší než 55 % nezávisle na hodnotě D-dimeru. Závěr: Stanovení hodnot D-dimeru je naprosto zásadní při screeningu hluboké žilní trombózy u pacientů s onemocněním COVID-19, protože vyšší hodnoty D-dimeru jsou spojeny s vyšší mortalitou a přítomností hluboké žilní trombózy.
Aim: The aim of the present study was to analyze D-dimer levels and associate these levels with deep vein thrombosis and mortality in patients with COVID-19. Method: From a population of approximately 1200 patients evaluated for the investigation of deep vein thrombosis (DVT) of the lower limbs using bilateral venous Doppler ultrasound, 100 positive for DVT and 100 negative for DVT were selected to compose the present sample. Data were collected on sex, age and D-dimer levels. D-dimer levels were categorized as follows: > 20 μg/mL, 10 to 20 μg/mL, 5 to 10 μg/mL, 3 to 5 μg/mL and < 3 μg/mL. The association between D-dimer category and mortality was evaluated. Results: The mean D-dimer level was 11.90 and 4.97 μg/mL in the groups with and without DVT; this difference was significant (p = 0.0001, paired t-test). The mortality rate was higher than 35% in patients without DVT and with D-dimer > 3 μg/mL. In the group with DVT, the mortality rate was higher than 55% independently of the D-dimer level. Conclusion: The assessment of the D-dimer level is fundamental in screening for deep vein thrombosis in patients with COVID-19, as higher levels are associated with greater mortality and the presence of deep vein thrombosis.
Úvod: Pľúcna embólia je relatívne časté a nebezpečné ochorenie s variabilnou manifestáciou od benignej až po fatálnu. Autori v retrospektívnej štúdii prezentujú, ako sa počas posledných 25 rokov menil výskyt, diagnostika a liečba pľúcnej embólie. Metódy: Autori vychádzali z dokumentácie 860 (432 mužov) pacientov s potvrdenou pľúcnou embóliou, ktorí boli hospitalizovaní v čase od januára 1996 do decembra 2020 na I. internej klinike Univerzitnej nemocnice v Martine. Zamerali sa na výskyt, rizikové faktory, diagnostiku a liečbu pľúcnej embólie v jednotlivých rokoch v tomto časovom období. Výsledky: Pacienti s potvrdenou pľúcnou embóliou tvorili 1,04 % zo všetkých hospitalizovaných pacientov v uvedenom časovom období s priemerným vekom 63,9 (SD - 16,98). Priemerný vek mužov 59,6 (SD - 14,71) bol oproti ženám 68,4 (SD - 16,88) nižší. Na základe rizikovej stratifikácie podľa odporučení Európskej kardiologickej spoločnosti pacienti s pľúcnou embóliou a vysokým rizikom tvorili 13,2 %, so stredným rizikom 40,9 % a nízkym rizikom 45,9 %. Zdroj pľúcnej embólie bol odhalený u 42,6 % a rizikové faktory žilového tromboembolizmu u 52,4 % pacientov a systémová trombolýza bola podaná u 19,5 % zo všetkých pacientov s pľúcnou embóliou. Intrakraniálne krvácanie ako komplikácia systémovej trombolýzy sa vyskytla u 1,1 % pacientov. Včasná (hospitalizačná) mortalita na pľúcnu embóliu bola 6,9 %. Záver: Autori potvrdili narastajúcu incidenciu pľúcnej embólie, klesajúcu incidenciu pľúcnej embólie s vysokým rizikom, znižujúcu sa včasnú mortalitu na pľúcnu embóliu, nepotvrdili narastajúci priemerný vek pacientov s pľúcnou embóliou.
Background: Pulmonary embolism is relatively a frequent and dangerous disease with varied manifestations ranging from benign to fatal. The authors in a retrospective study presented a change in the incidence, diagnosis, and treatment of pulmonary embolism during the last 25 years. Methods: The authors performed a retrospective analysis of 860 (432 men) patients with definitely confirmed pulmonary embolism, who were hospitalized at the Department of Internal Medicine of University Hospital in Martin from January 1996 to December 2020. The source of information about patients were their medical documentations. The authors pointed view on an incidence, risk factors, diagnosis and treatment of pulmonary embolism during presented period. Results: The patients with confirmed pulmonary embolism created 1.04% of all hospitalized patients with average age 63.9 (SD - 16.98). The average age of men 59.6 (SD - 14.71) was lower compared with women 68.4 (SD - 16.88). Based on the European Society of Cardiology risk stratification, there were pulmonary embolism with high risk in 13.2%, intermediate risk in 40.9% and low risk in 45.9% patients. The source of thrombosis was detected in 42.6% and risk factors for venous thromboembolism in 52.4% of them. 19.5% of all patients with pulmonary embolism were treated with systemic thrombolysis and intracranial bleeding occurred in 1.1% of them. Pulmonary embolism related early mortality rate was 6.9%. Conclusions: The authors confirmed increasing annual incidence of pulmonary embolism, decreasing annual incidence of massive pulmonary embolism, decreasing pulmonary embolism related mortality rate, but not increasing average age of patients with pulmonary embolism during presented period.
BACKGROUND: Thrombosis and pulmonary embolism appear to be major causes of mortality in hospitalized coronavirus disease 2019 (COVID-19) patients. However, few studies have focused on the incidence of venous thromboembolism (VTE) after hospitalization for COVID-19. METHODS: In this multi-center study, we followed 1529 COVID-19 patients for at least 45 days after hospital discharge, who underwent routine telephone follow-up. In case of signs or symptoms of pulmonary embolism (PE) or deep vein thrombosis (DVT), they were invited for an in-hospital visit with a pulmonologist. The primary outcome was symptomatic VTE within 45 days of hospital discharge. RESULTS: Of 1529 COVID-19 patients discharged from hospital, a total of 228 (14.9%) reported potential signs or symptoms of PE or DVT and were seen for an in-hospital visit. Of these, 13 and 12 received Doppler ultrasounds or pulmonary CT angiography, respectively, of whom only one patient was diagnosed with symptomatic PE. Of 51 (3.3%) patients who died after discharge, two deaths were attributed to VTE corresponding to a 45-day cumulative rate of symptomatic VTE of 0.2% (95%CI 0.1%-0.6%; n = 3). There was no evidence of acute respiratory distress syndrome (ARDS) in these patients. Other deaths after hospital discharge included myocardial infarction (n = 13), heart failure (n = 9), and stroke (n = 9). CONCLUSIONS: We did not observe a high rate of symptomatic VTE in COVID-19 patients after hospital discharge. Routine extended thromboprophylaxis after hospitalization for COVID-19 may not have a net clinical benefit. Randomized trials may be warranted.
- MeSH
- časové faktory MeSH
- COVID-19 diagnóza epidemiologie mortalita terapie MeSH
- dospělí MeSH
- incidence MeSH
- lidé středního věku MeSH
- lidé MeSH
- plicní embolie diagnóza epidemiologie mortalita MeSH
- propuštění pacienta * MeSH
- prospektivní studie MeSH
- rizikové faktory MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- žilní tromboembolie diagnóza epidemiologie mortalita MeSH
- žilní trombóza diagnóza epidemiologie mortalita MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
- Geografické názvy
- Írán MeSH
BACKGROUND: The outcomes of deep vein thrombosis (DVT) in children with May-Thurner Syndrome (MTS) remain unclear. OBJECTIVES: This systematic review and patient-level meta-analysis aims to describe the outcomes of children with MTS presenting with DVT. METHODS: A systematic review of the published literature was performed. Data related to patients <18 years diagnosed with MTS and DVT was extracted. Risk of bias was assessed using the Murad criteria. Outcomes included vessel patency post-treatment, DVT recurrence, and post-thrombotic syndrome (PTS). Predictive and explanatory models were developed for these outcomes. RESULTS: In total, 109 cases were identified (age range 4-17 years; 77 females) in 28 studies; 75% of patients had ≥1 additional risk factor for DVT. PTS was seen in 61% of patients, DVT recurrence in 38%, and complete vessel patency post-treatment in 65%. The models developed to predict and explain PTS performed poorly overall. Recurrent thrombosis (adjusted for age and patency) predicted PTS (odds ratio [OR] 3.36, 95% confidence interval [CI] 1.28-8.82). DVT management strategies (adjusted for age and DVT characteristics) predicted vessel patency (OR 2.10, 95% CI 1.43-3.08). Lack of complete vessel patency (adjusted for age and thrombophilia) predicted recurrent DVT (OR 2.70, 95% CI 1.09-6.67). Sensitivity analyses showed the same direction of effects for all outcomes. CONCLUSIONS: PTS and DVT recurrence occur frequently in pediatric MTS. PTS prediction is complex and it was not possible to identify early predictors to guide clinical practice. Use of imaging-guided therapy and thrombus burden predicted venous patency, and lack of patency predicted DVT recurrence.
- MeSH
- dítě MeSH
- lidé MeSH
- May-Thurnerův syndrom * MeSH
- mladiství MeSH
- posttrombotický syndrom * MeSH
- předškolní dítě MeSH
- průchodnost cév MeSH
- vena iliaca MeSH
- výsledek terapie MeSH
- žilní trombóza * epidemiologie MeSH
- Check Tag
- dítě MeSH
- lidé MeSH
- mladiství MeSH
- předškolní dítě MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- metaanalýza MeSH
- systematický přehled MeSH
Onemocnění COVID-19 způsobené koronavirem SARS-CoV-2 vedlo ke vzniku celosvětové pandemie spojené s významnou morbiditou i mortalitou. Od počátku bylo známo, že je spojeno i s vysokým rizikem vzniku trombózy, a to jak žilní, tak tepenné. S chorobou spojená koagulopatie s náchylností k trombóze je velmi komplexní geneze a zahrnuje působení viru, respektive i reakci napadeného organismu na různých místech krevního srážení. To vedlo od počátku k definování léčebných postupů ve snaze zamezit protrombotické tendenci. Tento přehled shrnuje názory na patofyziologii koagulopatie spojené s COVID-19 a taktéž různá doporučení pro profylaxi a léčbu takto indukovaného tromboembolismu.
A disease COVID-19 associated with SARS-CoV-2 coronavirus infection led to world spread pandemic situation connected with considerable morbidity and mortality. It has been associated with high risk of thrombosis, both venous and arterial, started with an initial information. Disease connecting coagulopathy with thrombotic tendency is with very complex pathophysiology and it includes as well as virus action and also reaction of attached organism in different places of haemostasis. This review summarizes recent opinions to pathophysiology on COVID-19 associated coagulopathy and also recent overview of guidelines for management of prophylaxis and treatment of such induced thromboembolism.
- Klíčová slova
- Clexane, Clexane Forte,
- MeSH
- antikoagulancia aplikace a dávkování chemie farmakologie MeSH
- chemoprofylaxe klasifikace MeSH
- COVID-19 epidemiologie komplikace MeSH
- extracelulární pasti imunologie metabolismus MeSH
- heparin nízkomolekulární aplikace a dávkování chemie farmakologie MeSH
- inhibitory faktoru Xa aplikace a dávkování farmakologie MeSH
- lidé MeSH
- neutrofily imunologie metabolismus MeSH
- péče o pacienty v kritickém stavu MeSH
- plicní embolie diagnostické zobrazování epidemiologie farmakoterapie MeSH
- tromboembolie * diagnostické zobrazování farmakoterapie patofyziologie MeSH
- žilní trombóza diagnostické zobrazování epidemiologie farmakoterapie MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- práce podpořená grantem MeSH
- MeSH
- diferenciální diagnóza MeSH
- lidé MeSH
- nádory * MeSH
- prognóza MeSH
- recidiva MeSH
- rizikové faktory MeSH
- žilní trombóza * epidemiologie komplikace terapie MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- přehledy MeSH
- MeSH
- chemoprofylaxe MeSH
- flavony farmakologie terapeutické užití MeSH
- hematologické komplikace těhotenství * klasifikace MeSH
- heparin nízkomolekulární aplikace a dávkování MeSH
- lidé MeSH
- plicní embolie etiologie prevence a kontrola MeSH
- rizikové faktory MeSH
- tromboembolie diagnostické zobrazování epidemiologie etiologie MeSH
- trombofilie diagnóza prevence a kontrola MeSH
- tromboflebitida diagnóza etiologie komplikace MeSH
- varixy epidemiologie etiologie komplikace MeSH
- žilní insuficience diagnóza farmakoterapie MeSH
- žilní trombóza epidemiologie etiologie prevence a kontrola MeSH
- Check Tag
- lidé MeSH
- ženské pohlaví MeSH
