Full recovery from spinal cord injury requires axon regeneration to re-establish motor and sensory pathways. In mammals, the failure of sensory and motor axon regeneration has many causes intrinsic and extrinsic to neurons, amongst which is the lack of adhesion molecules needed to interact with the damaged spinal cord. This study addressed this limitation by expressing the integrin adhesion molecule α9, along with its activator kindlin-1, in sensory neurons via adeno-associated viral (AAV) vectors. This enabled sensory axons to regenerate through spinal cord injuries and extend to the brainstem, restoring sensory pathways, touch sensation and sensory behaviours. One of the integrin ligands in the injured spinal cord is tenascin-C, which serves as a substrate for α9β1 integrin, a key receptor in developmental axon guidance. However, the adult PNS and CNS neurons lack this receptor. Sensory neurons were transduced with α9 integrin (which pairs with endogenous β1 to form a α9β1 tenascin receptor) together with the integrin activator kindlin-1. Regeneration from sensory neurons transduced with α9integrin and kindlin-1 was examined after C4 and after T10 dorsal column lesions with C6,7 and L4,5 sensory ganglia injected with AAV1 vectors. In animals treated with α9 integrin and kindlin-1, sensory axons regenerated through tenascin-C-expressing connective tissue strands and bridges across the lesions and then re-entered the CNS tissue. Many axons regenerated rostrally to the level of the medulla. Axons grew through the dorsal grey matter rather than their normal pathway the dorsal columns. Growth was slow, axons taking 12 weeks to grow from T10 to the medulla, a distance of 4-5 cm. Functional recovery was confirmed through cFos activation in neurons rostral to the injury after nerve stimulation and VGLUT1/2 staining indicating new synapse formation above the lesion. Behavioural recovery was seen in both heat and mechanical sensation, as well as tape removal tests. This approach demonstrates the potential of integrin-based therapies for long distance sensory axon regeneration and functional recovery following thoracic and partial recovery after cervical spinal cord injury.
- Klíčová slova
- AAV vectors, Axon regeneration, Integrins, Kindlin, Sensory testing, Spinal cord injury,
- MeSH
- axony MeSH
- Dependovirus genetika MeSH
- genetické vektory MeSH
- krysa rodu Rattus MeSH
- modely nemocí na zvířatech MeSH
- myši MeSH
- nervové receptory * metabolismus fyziologie patologie MeSH
- obnova funkce fyziologie MeSH
- poranění míchy * patologie patofyziologie metabolismus MeSH
- potkani Sprague-Dawley MeSH
- proteiny nervové tkáně metabolismus genetika MeSH
- regenerace nervu * fyziologie MeSH
- tenascin metabolismus MeSH
- zvířata MeSH
- Check Tag
- krysa rodu Rattus MeSH
- myši MeSH
- ženské pohlaví MeSH
- zvířata MeSH
- Publikační typ
- časopisecké články MeSH
- Názvy látek
- proteiny nervové tkáně MeSH
- tenascin MeSH
OBJECTIVES: The aim of this study was to investigate the long-term effects of computer-assisted Ci™ navigation on clinical, radiological, and functional results versus conventional total knee arthroplasty (TKA). PATIENTS AND METHODS: Between January 2005 and July 2011, a total of 85 patients (36 males, 49 females; mean age: 66.2±5.2 years; range, 59 to 84 years) who underwent P.F.C. Sigma™ knee system implantation using computer-assisted Ci™ navigation system (BrainLAB®, DePuy International, Leeds, UK) and completed a minimum follow-up of eight years were included in the study. In the control group, a total of 100 patients (40 males, 60 females; mean age: 68.3±3.9 years; range, 60 to 79 years) who completed a minimum follow-up of eight years were randomly selected from a dataset of implanted P.F.C. Sigma™ knee systems in the same period using Specialist® 2 instrumentation without navigation. An implant survival analysis was used to compare implant survivorship between the groups throughout 12 years. The Knee Society Score (KSS) and range of motion (ROM) were assessed. Based on long-format X-ray images, the implant position in the frontal and sagittal planes was evaluated. RESULTS: The ratio for navigation to control group survival is approximately 1.01 at 12 years. The clinical outcomes showed no significant difference between the groups (knee scores, p=0.707 and functional scores, p=0.485). In the measured angles analysis, we observed a consistent pattern in both groups. In the control group, there was a trend toward implanting the tibial component with slight varus alignment (p=0.038) and a higher posterior slope (p<0.001). On average, the operation was prolonged by 13 min in the navigated group (p<0.001). CONCLUSION: In conclusion, our study results demonstrate that while kinematic navigation in TKA improves the precision of implant alignment, it does not provide significant benefits in terms of long-term implant survival or functional outcomes compared to conventional TKA methods. The use of the computer-assisted Ci™ navigation system is associated with prolonged operation duration, although no technical complications related to the navigation device's software can be observed. Therefore, although navigation offers theoretical advantages in component positioning, its use may be more justifiable in cases with challenging alignment requirements rather than as a routine practice.
- MeSH
- artróza kolenních kloubů * chirurgie patofyziologie diagnostické zobrazování MeSH
- časové faktory MeSH
- chirurgie s pomocí počítače * škodlivé účinky metody přístrojové vybavení MeSH
- kolenní kloub * chirurgie diagnostické zobrazování patofyziologie MeSH
- lidé středního věku MeSH
- lidé MeSH
- následné studie MeSH
- obnova funkce MeSH
- protézy kolene MeSH
- retrospektivní studie MeSH
- rozsah kloubních pohybů MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- totální endoprotéza kolene * metody přístrojové vybavení škodlivé účinky MeSH
- výsledek terapie MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- srovnávací studie MeSH
Therapeutic plasma exchange (PLEX) is an adjunctive treatment for patients with anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis and kidney involvement. Little is known about the effect of PLEX on early changes in kidney function. This post-hoc analysis of the PEXIVAS trial investigated the effects of PLEX on changes in kidney function within 12 months. PEXIVAS was a randomized controlled trial recruiting 691 patients with ANCA-associated glomerulonephritis, of whom 349 underwent PLEX and 342 received no-PLEX. The primary outcomes of this post hoc study of PEXIVAS were change in estimated glomerular filtration rate (eGFR) from baseline and recovery of kidney function (defined as eGFR increase of 15ml/min/1.73m2 or more). Baseline eGFR was 21.7 ± 20.3 and 20.6 ± 18.7 ml/min/1.73m2 in the PLEX and no-PLEX groups, respectively. Mean improvements in eGFR at weeks two, four, and eight after initiation of therapy were greater for the PLEX vs. the no-PLEX groups. The greatest significant difference in recovery of kidney function in the PLEX compared to the no-PLEX groups was at week four (relative risk (RR): 1.41; 95% confidence interval:1.09-1.82). Increased eGFR or recovery of kidney function at week four were significantly associated with lower risk for end-stage kidney disease at week 52 (RR: 0.96: 0.95-0.97, and RR: 0.29: 0.16-0.52; respectively). Neither changes in eGFR nor recovery of kidney function differed by reduced- compared to standard-dose glucocorticoid group. Overall, our study indicates that PLEX improves early kidney function in patients with ANCA-associated glomerulonephritis.
- Klíčová slova
- ANCA, end-stage kidney disease, glomerulonephritis, kidney function, plasma exchange, vasculitis,
- MeSH
- ANCA-asociované vaskulitidy * terapie komplikace imunologie MeSH
- časové faktory MeSH
- dospělí MeSH
- glomerulonefritida * terapie imunologie patofyziologie MeSH
- glukokortikoidy * terapeutické užití škodlivé účinky aplikace a dávkování MeSH
- hodnoty glomerulární filtrace účinky léků MeSH
- ledviny * patofyziologie účinky léků MeSH
- lidé středního věku MeSH
- lidé MeSH
- obnova funkce MeSH
- senioři MeSH
- výměna plazmy * škodlivé účinky MeSH
- výsledek terapie 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
- randomizované kontrolované studie MeSH
- Názvy látek
- glukokortikoidy * MeSH
BACKGROUND: Management of recurrent mitral regurgitation (MR) or relevant iatrogenic mitral valve (MV) stenosis after mitral transcatheter edge-to-edge repair (M-TEER) emerges as an increasingly relevant clinical issue. Surgery after M-TEER is associated with higher morbidity and mortality. Electrosurgical leaflet laceration and stabilization of the implant (ELASTA-Clip) followed by transcatheter mitral valve replacement (TMVR) is an innovative, less-invasive treatment option for patients with TEER failure. OBJECTIVES: The authors sought to evaluate the early results of ELASTA-Clip followed by transapical TMVR in patients with symptomatic failed M-TEER (defined as persistent or recurrent MR, or iatrogenic MV stenosis). METHODS: Data from symptomatic patients with failed M-TEER who underwent ELASTA-Clip followed by compassionate use or commercial transapical TMVR using the Abbott Tendyne system were retrospectively collected from 8 tertiary care centers in 4 countries. Safety and efficacy of the procedure were assessed up to 1 year according to Mitral Valve Academic Research Consortium (MVARC) criteria. RESULTS: A total of 22 patients (mean age 77.8 ± 9.2 years, 40.9% [9/22] female) at high surgical risk (EuroSCORE II 8.0 ± 0.4, STS score 7.2% ± 1.1%) with symptomatic residual MR ≥3+ (n = 21) or iatrogenic MV stenosis (n = 1) after failed M-TEER were followed for a median period of 8.5 [Q1-Q3: 2.6-11.6] months. The ELASTA-Clip procedure (90.9% [20/22] transseptal, 9.1% [2/22] transapical) followed by TMVR were successful in all patients (22/22). Technical success according to MVARC was achieved in 21 patients (21/22, 95.4%) without left ventricular outflow tract obstruction or conversion to sternotomy. At 30 days, 3 patients had paravalvular leak progression, ischemic stroke occurred in 3 patients (3/20, 15.0%). Baseline MR (≥3+ in 95.5% [21/22]) was reduced to grade 1+ or less in all patients with durable results in 89.5% (17/19) (P < 0.001). NYHA functional class significantly improved to ≤II in 81.3% (13/16) at discharge (P < 0.001) and 72.2% (13/18) at last follow-up (P < 0.001). At 30 days, all patients (20/20) were alive. Three patients (3/20, 15.0%) were rehospitalized for heart failure (uncontrolled atrial fibrillation in 2 cases) and 1 of them (1/22, 4.5%) underwent a reintervention (valve retensioning). CONCLUSIONS: Transapical TMVR after ELASTA-Clip is a feasible and less invasive option for the management of failed M-TEER that can be performed with acceptable results in a carefully selected patient population. Particular attention is required to avoid paravalvular leakage and measures to minimize the risk of periprocedural cerebrovascular events need to be implemented in future larger-scale prospective studies with longer-term follow-up.
- Klíčová slova
- ELASTA-Clip, edge-to-edge repair, mitral regurgitation, transcatheter electrosurgery, transcatheter mitral valve repair, transcatheter mitral valve replacement,
- MeSH
- časové faktory MeSH
- chirurgická náhrada chlopně * škodlivé účinky přístrojové vybavení metody MeSH
- compassionate use trials MeSH
- iatrogenní nemoci MeSH
- lidé MeSH
- mitrální chlopeň * chirurgie patofyziologie diagnostické zobrazování MeSH
- mitrální insuficience * diagnostické zobrazování patofyziologie chirurgie MeSH
- mitrální stenóza * diagnostické zobrazování patofyziologie chirurgie etiologie MeSH
- neúspěšná terapie MeSH
- obnova funkce MeSH
- protézy - design MeSH
- recidiva MeSH
- retrospektivní studie MeSH
- rizikové faktory MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- srdeční chlopně umělé MeSH
- srdeční katetrizace * škodlivé účinky přístrojové vybavení mortalita MeSH
- výsledek terapie MeSH
- Check Tag
- 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
- Evropa MeSH
INTRODUCTION: Atrial fibrillation (AF) can cause or aggravate heart failure (HF). Catheter ablation (CA) is an effective treatment for AF. This study focused on the feasibility and outcomes of emergent AF ablation performed during hospitalization for acute HF. METHODS AND RESULTS: We retrospectively investigated patients who underwent emergent CA for AF during hospitalization for acute HF in 2018-2024. Arrhythmia recurrence was the primary endpoint. The combination of arrhythmia recurrence, HF hospitalization, and all-cause death was the secondary endpoint. Patients were censored 1 year after the index procedure. We included 46 patients, 35% females, with median age of 67 [interquartile rage: 61, 72] years and left ventricular ejection fraction (LVEF) of 25 [23, 28]%. Thermal CA was performed in 14 patients, and pulsed field ablation (PFA) in 32 patients. Procedure time was significantly shorter with PFA compared to thermal CA (77 [57, 91] vs. 166 [142, 200] minutes, p < 0.001). Fluoroscopy time was longer with PFA (9.5 [7.6, 12.0] vs. 3.9 [2.9, 6.0] minutes, p < 0.001), with a borderline trend towards higher radiation dose (75 [53, 170] vs. 50 [30, 94] μGy.m2, p = 0.056). Extrapulmonary ablation was frequent (86% and 84% for thermal CA and PFA, p > 0.9). The estimated freedom from the primary endpoint was 79% after PFA and 64% after thermal CA (p = 0.44). The estimated freedom from the secondary endpoint was 76% after PFA and 57% after thermal CA (p = 0.43). LVEF improved by 24% ± 2% (p < 0.001) in patients with the first manifestation of HF and by 14% ± 4% (p = .004) in patients with decompensated HF diagnosed earlier. CONCLUSIONS: Emergent CA of AF during acute HF hospitalization is safe and associated with improved LVEF and good clinical outcomes. In the PFA era, the rate of these procedures is progressively increasing as they are readily available and easy to perform compared to thermal ablation.
- Klíčová slova
- acute heart failure, atrial fibrillation, catheter ablation, electroporation, posterior wall isolation, pulsed field ablation, thermal ablation,
- MeSH
- akční potenciály MeSH
- akutní nemoc MeSH
- časové faktory MeSH
- fibrilace síní * chirurgie patofyziologie mortalita diagnóza komplikace MeSH
- funkce levé komory srdeční MeSH
- hospitalizace * MeSH
- katetrizační ablace * škodlivé účinky mortalita metody MeSH
- lidé středního věku MeSH
- lidé MeSH
- obnova funkce MeSH
- příjem pacientů * MeSH
- recidiva MeSH
- retrospektivní studie MeSH
- rizikové faktory MeSH
- senioři MeSH
- srdeční frekvence MeSH
- srdeční selhání * patofyziologie mortalita diagnóza terapie MeSH
- studie proveditelnosti MeSH
- tepový objem MeSH
- výsledek terapie MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
PURPOSE: There is variation in organization of geriatric rehabilitation across Europe. The purpose of this study was to describe the selection criteria for referral to geriatric rehabilitation, care provided, and recovery trajectories of post-COVID-19 patients referred to geriatric rehabilitation in Europe. METHODS: This observational cohort study included 723 patients in 59 care facilities for geriatric rehabilitation across 10 countries. Patient data were collected from medical records on admission to geriatric rehabilitation (between September 2020 and October 2021), discharge, 6 weeks and 6 months follow-up. The primary and secondary outcomes were recovery in daily functioning (Barthel Index) and Quality of Life (EQ-5D-5L) from admission to discharge. These were examined using linear mixed models with two levels (measurements nested in patients) and country as an independent variable. Random intercept and random linear slope parameters were added when they improved model fit. A survey about organization of geriatric rehabilitation for post-COVID-19 patients was filled out by country coordinators and data were analyzed using descriptive statistics and inductive coding of answers to open questions. RESULTS: Patients had a mean age of 75.7 years old and 52.4% were male. Many countries used various combinations of the selection criteria, such as functional status, age, frailty, Comprehensive Geriatric Assessment, comorbidities, and cognitive impairments. Most patients received physiotherapy (88.8%) and occupational therapy (69.7%), but there was substantial variance between countries in the percentages of patients that received protein or calorie enriched diets, oxygen therapy, and other treatment components. In all countries, patients showed recovery in daily functioning and quality of life, although there was variation in between countries in rate of recovery. Daily functioning seemed to increase most rapidly in the Czech Republic, Germany, and Russia. The steepest increases in quality of life were seen in the Czech Republic, Germany, and Spain. CONCLUSION: Post-COVID-19 patients showed recovery during geriatric rehabilitation, albeit at variable rates. The observed variation may be explained by the heterogeneity in selection criteria and care provided. This study highlights the need for harmonization of measurements in geriatric rehabilitation order to perform explanatory research and optimize geriatric rehabilitation throughout Europe to ensure optimal patient recovery.
- Klíčová slova
- COVID-19, Europe, Geriatric rehabilitation, Recovery,
- MeSH
- činnosti denního života MeSH
- COVID-19 * rehabilitace epidemiologie MeSH
- geriatrické hodnocení MeSH
- kohortové studie MeSH
- kvalita života MeSH
- lidé MeSH
- obnova funkce MeSH
- SARS-CoV-2 fyziologie MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- Check Tag
- lidé MeSH
- mužské pohlaví MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
- pozorovací studie MeSH
- srovnávací studie MeSH
- Geografické názvy
- Evropa epidemiologie MeSH
OBJECTIVES: Delirium is common during acute infection in older patients and is associated with functional decline. Geriatric rehabilitation (GR) can help older patients to return to their premorbid functional level. It is unknown whether delirium affects GR outcomes in patients with acute infection. We evaluated whether delirium affects trajectories of activities of daily living (ADL) and quality of life (QoL) recovery in GR after COVID-19 infection. DESIGN: This study was part of the EU-COGER study, a multicenter cohort study conducted between October 2020 and October 2021. SETTING AND PARTICIPANTS: Participants were recruited after COVID-19 infection from 59 GR centers in 10 European countries. METHODS: Data were collected at GR admission, discharge, and at the 6-week and 6-month follow-ups. Trajectories of ADL [using the Barthel index (BI)] and QoL [using the EuroQol-5 Dimensions-5 Level (EQ-5D-5L)] recovery were examined using linear mixed models. RESULTS: Of the 723 patients included (mean age 75.5 ± 9.9 years; 52.4% male), 28.9% had delirium before or during GR admission. Participants with delirium recovered in ADL at approximately the same rate as those without (linear slope effect = -0.13, SE 0.16, P = .427) up to an estimated BI score of 16.1 at 6 months. Similarly, participants with delirium recovered in QoL at approximately the same rate as those without (linear slope effect = -0.017, SE 0.015, P = .248), up to an estimated EQ-5D-5L score of 0.8 at 6 months. CONCLUSIONS AND IMPLICATIONS: Presence of delirium during the acute phase of infection or subsequent GR did not influence the recovery trajectory of ADL functioning and QoL.
- Klíčová slova
- ADL, COVID-19, Delirium, Geriatric rehabilitation, Older adults, QoL, Recovery,
- MeSH
- činnosti denního života MeSH
- COVID-19 * rehabilitace MeSH
- delirium * komplikace MeSH
- geriatrické hodnocení MeSH
- kohortové studie MeSH
- kvalita života * MeSH
- lidé MeSH
- obnova funkce MeSH
- SARS-CoV-2 MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- Check Tag
- 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
- Evropa MeSH
BACKGROUND: Health-related quality of life (HRQL) is an important goal for patients with major depressive disorder (MDD), but whether antidepressants improve HRQL in these patients is unclear. Here, we describe the real-world effects of trazodone once-a-day (TzOAD) and selective serotonin reuptake inhibitor (SSRI) treatments on HRQL and functioning in adults with MDD. METHODS: This 8-week prospective, observational, open-label, multicenter study was conducted in adults with moderate or severe MDD for whom TzOAD or SSRI were prescribed as monotherapy. The primary outcome was life enjoyment and satisfaction assessed via the patient-reported Quality-of-Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF) from baseline to week 8. Secondary outcomes included change in Q-LES-Q-SF from baseline to weeks 1 and 2; severity of depressive symptoms using the Montgomery Åsberg Depression Rating Scale (MADRS) and sleep disturbance via the PROMIS SF-SD 8b questionnaire at weeks 1, 2, and 8; and overall functioning via the Sheehan Disability Scale (SDS), hedonic capacity using the Snaith-Hamilton Pleasure Scale (SHAPS), and cognitive dysfunction using the Perceived Deficits Questionnaire (PDQ-5) at baseline and week 8. RESULTS: The study included 208 adults with MDD (mean [SD] age = 50.2 [14.3] years; 68.6% female; 98.4% White). Life enjoyment and satisfaction improved from baseline to week 8 for both treatment groups: Q-LES-Q-SF mean (SD) scores were 27.5 (20.4) for the SSRI group and 39.0 (22.1) for the TzOAD group. Depressive symptoms and sleep disturbances also reduced from baseline to week 8: MADRS (SSRI, -15.7 [8.3]; TzOAD, -21.0 [9.8]); PROMIS SF-SD 8b (SSRI, -9.9 [12.6]; TzOAD, -22.0 [12.6]). Mean change scores in Q-LES-Q-SF, MADRS, and PROMIS SF-SD 8b improved as early as week 1 in both groups. Mean scores also improved from baseline to week 8 on SDS (SSRI, -9.2 [7.4]; TzOAD, -14.3 [7.5]), SHAPS (SSRI, -6.6 [4.3]; TzOAD, -8.3 [4.4]), and PDQ-5 (SSRI, -5.8 [4.5]; TzOAD, -7.7 [5.0]). CONCLUSIONS: In adults with MDD who received TzOAD or SSRIs, overall and individual HQRL domains improved rapidly and in parallel with improvements in depressive symptoms, with a slightly greater improvement observed in the TzOAD group.
- Klíčová slova
- health‐related quality of life (HRQL), major depressive disorder, selective serotonin reuptake inhibitors, trazodone,
- MeSH
- antidepresiva druhé generace aplikace a dávkování terapeutické užití farmakologie MeSH
- depresivní porucha unipolární * farmakoterapie patofyziologie MeSH
- dospělí MeSH
- kvalita života * MeSH
- lidé středního věku MeSH
- lidé MeSH
- obnova funkce účinky léků MeSH
- prospektivní studie MeSH
- selektivní inhibitory zpětného vychytávání serotoninu * aplikace a dávkování farmakologie MeSH
- trazodon * farmakologie aplikace a dávkování MeSH
- výsledek terapie MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
- pozorovací studie MeSH
- Názvy látek
- antidepresiva druhé generace MeSH
- selektivní inhibitory zpětného vychytávání serotoninu * MeSH
- trazodon * MeSH
BACKGROUND: After an acute infection, older persons may benefit from geriatric rehabilitation (GR). OBJECTIVES: This study describes the recovery trajectories of post-COVID-19 patients undergoing GR and explores whether frailty is associated with recovery. DESIGN: Multicentre prospective cohort study. SETTING: 59 GR facilities in 10 European countries. PARTICIPANTS: Post-COVID-19 patients admitted to GR between October 2020 and October 2021. METHODS: Patients' characteristics, daily functioning (Barthel index; BI), quality of life (QoL; EQ-5D-5L) and frailty (Clinical Frailty Scale; CFS) were collected at admission, discharge, 6 weeks and 6 months after discharge. We used linear mixed models to examine the trajectories of daily functioning and QoL. RESULTS: 723 participants were included with a mean age of 75 (SD: 9.91) years. Most participants were pre-frail to frail (median [interquartile range] CFS 6.0 [5.0-7.0]) at admission. After admission, the BI first steeply increased from 11.31 with 2.51 (SE 0.15, P < 0.001) points per month and stabilised around 17.0 (quadratic slope: -0.26, SE 0.02, P < 0.001). Similarly, EQ-5D-5L first steeply increased from 0.569 with 0.126 points per month (SE 0.008, P < 0.001) and stabilised around 0.8 (quadratic slope: -0.014, SE 0.001, P < 0.001). Functional recovery rates were independent of frailty level at admission. QoL was lower at admission for frailer participants, but increased faster, stabilising at almost equal QoL values for frail, pre-frail and fit patients. CONCLUSIONS: Post-COVID-19 patients admitted to GR showed substantial recovery in daily functioning and QoL. Frailty at GR admission was not associated with recovery and should not be a reason to exclude patients from GR.
- Klíčová slova
- COVID-19, geriatric rehabilitation, older people, recovery,
- MeSH
- činnosti denního života * MeSH
- COVID-19 * rehabilitace epidemiologie psychologie MeSH
- geriatrické hodnocení * metody MeSH
- křehkost * diagnóza rehabilitace psychologie MeSH
- křehký senior * MeSH
- kvalita života * MeSH
- lidé MeSH
- obnova funkce * MeSH
- prospektivní studie MeSH
- SARS-CoV-2 MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- Check Tag
- lidé MeSH
- mužské pohlaví MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
- práce podpořená grantem MeSH
- Geografické názvy
- Evropa MeSH
BACKGROUND: Delayed hypothermia, initiated after hospital arrival, several hours after cardiac arrest with 8-10 hours to reach the target temperature, is likely to have limited impact on overall survival. However, the effect of ultrafast hypothermia, i.e., delivered intra-arrest or immediately after return of spontaneous circulation (ROSC), on functional neurologic outcome after out-of-hospital cardiac arrest (OHCA) is unclear. In two prior trials, prehospital trans-nasal evaporative intra-arrest cooling was safe, feasible and reduced time to target temperature compared to delayed cooling. Both studies showed trends towards improved neurologic recovery in patients with shockable rhythms. The aim of the PRINCESS2-study is to assess whether cooling, initiated either intra-arrest or immediately after ROSC, followed by in-hospital hypothermia, significantly increases survival with complete neurologic recovery as compared to standard normothermia care, in OHCA patients with shockable rhythms. METHODS/DESIGN: In this investigator-initiated, randomized, controlled trial, the emergency medical services (EMS) will randomize patients at the scene of cardiac arrest to either trans-nasal cooling within 20 minutes from EMS arrival with subsequent hypothermia at 33°C for 24 hours after hospital admission (intervention), or to standard of care with no prehospital or in-hospital cooling (control). Fever (>37,7°C) will be avoided for the first 72 hours in both groups. All patients will receive post resuscitation care and withdrawal of life support procedures according to current guidelines. Primary outcome is survival with complete neurologic recovery at 90 days, defined as modified Rankin scale (mRS) 0-1. Key secondary outcomes include survival to hospital discharge, survival at 90 days and mRS 0-3 at 90 days. In total, 1022 patients are required to detect an absolute difference of 9% (from 45 to 54%) in survival with neurologic recovery (80% power and one-sided α=0,025, β=0,2) and assuming 2,5% lost to follow-up. Recruitment starts in Q1 2024 and we expect maximum enrolment to be achieved during Q4 2024 at 20-25 European and US sites. DISCUSSION: This trial will assess the impact of ultrafast hypothermia applied on the scene of cardiac arrest, as compared to normothermia, on 90-day survival with complete neurologic recovery in OHCA patients with initial shockable rhythm. TRIAL REGISTRATION: NCT06025123.
- MeSH
- časové faktory MeSH
- elektrická defibrilace metody MeSH
- kardiopulmonální resuscitace metody MeSH
- lidé MeSH
- obnova funkce * MeSH
- obnovení spontánní cirukulace MeSH
- randomizované kontrolované studie jako téma MeSH
- terapeutická hypotermie * metody MeSH
- urgentní zdravotnické služby * metody MeSH
- zástava srdce mimo nemocnici * terapie mortalita MeSH
- Check Tag
- lidé MeSH
- mužské pohlaví MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- práce podpořená grantem MeSH
- protokol klinické studie MeSH