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1.
Clin Neuroradiol ; 2022 Jan 14.
Artigo em Inglês | MEDLINE | ID: mdl-35028683

RESUMO

BACKGROUND: Spontaneous intracranial hypotension (SIH) is a debilitating condition requiring effective treatment; however, objective data on treatment response are scarce. PURPOSE: To assess the suitability of the brain MRI-based SIH score (bSIH) for monitoring treatment success in SIH patients with a proven spinal cerebrospinal fluid (CSF) leak after microsurgical closure of the underlying dural breach. METHODS: This retrospective cohort study included consecutive SIH patients with a proven spinal CSF leak, investigated at dedicated referral centre January 2012 to March 2020. The bSIH score integrates 6 imaging findings; 3 major (2 points) and 3 minor (1 point), and ranges from 0 to 9, with 0 indicating low and 9 high probability of spinal CSF loss. The score was calculated using brain magnetic resonance imaging (MRI) before and after surgical treatment of the underlying CSF leak. Headache intensity was registered on a numeric rating scale (NRS) (range 0-10). RESULTS: In this study 52 SIH patients, 35 (67%) female, mean age 45.3 years, with a proven spinal CSF leak were included. The mean bSIH score decreased significantly from baseline to after surgical closure of the underlying dural breach (6.9 vs. 1.3, P < 0.001). A decrease in the NRS score was reported (8.6 vs. 1.2, P < 0.001). CONCLUSION: The bSIH score is a simple tool which may serve to monitor treatment success in SIH patients after surgical closure of the underlying spinal dural leak. Its decrease after surgical closure of the underlying spinal dural breach indicates restoration of an equilibrium within the CSF compartment.

2.
Heart Rhythm ; 2021 Dec 28.
Artigo em Inglês | MEDLINE | ID: mdl-34971816

RESUMO

BACKGROUND: Operator-directed nurse-administered (ODNA) sedation with propofol is the preferred sedation technique for catheter ablation of atrial fibrillation (AF) in many centers. OBJECTIVE: We aimed to investigate whether Dexmedetomidine, an α2-adrenergic receptor agonist, is superior to propofol. METHODS: We randomized 160 consecutive patients undergoing first AF ablation to ODNA sedation by dexmedetomidine (DEX group) versus propofol (PRO group), according to a standardized protocol. Patients were unaware of treatment allocation. The primary endpoint was a composite of inefficient sedation, termination/change of sedation protocol or procedure abortion, hypercapnia (transcutaneous CO2 >55 mmHg), hypoxemia (SpO2 <90%) or intubation, prolonged hypotension (systolic blood pressure <80 mmHg), and sustained bradycardia necessitating cardiac pacing. Secondary endpoints were the components of the primary endpoint and patient satisfaction with procedural sedation, as assessed by a standardized questionnaire the day following ablation. RESULTS: The primary endpoint occurred in 15 DEX group and 25 PRO group patients (19% vs. 31%; p=0.068). Hypercapnia was significantly more frequent in PRO group patients (29% vs. 10%; p=0.003). There was no significant difference among the other components of the primary endpoint, no procedure was aborted. Patient satisfaction was significantly better in PRO group patients (visual analog scale 0-100; median 100 in PRO group vs. median 93 in DEX group; p<0.001). CONCLUSION: Efficacy of ODNA sedation with dexmedetomidine was not different to propofol. Hypercapnia occurs less frequent with dexmedetomidine, but patient satisfaction is better with propofol sedation. In selected patients, dexmedetomidine may be used as an alternative to propofol for ODNA sedation during AF ablation. (ClinicalTrials.gov number NCT03844841).

3.
Eur J Neurol ; 2021 Nov 26.
Artigo em Inglês | MEDLINE | ID: mdl-34826198

RESUMO

BACKGROUND AND PURPOSE: Patients with migraine are at increased risk of stroke. The aim was to systematically review the current literature on the association between migraine and atrial fibrillation, which is a relevant risk factor for stroke. METHODS: PubMed was searched for 'migraine' AND 'atrial fibrillation' and selected original investigations on the association of migraine and atrial fibrillation for our analysis. Articles without original data, such as guidelines, narrative reviews, editorials and others, were excluded. RESULTS: In all, 109 publications were found. Twenty-two were included and analysed for this review. The population-based Atherosclerosis Risk in Communities study showed a significant association of migraine with visual aura and incident atrial fibrillation (hazard ratio 1.30, 95% confidence interval 1.03-1.62, p = 0.02), but not for migraine without aura, compared to non-headache persons after multivariable adjustment for vascular risk factors. An even larger population-based study in Denmark confirmed this association (odds ratio 1.25, 95% confidence interval 1.16-1.36). Studies investigating patients with ischaemic stroke and migraine are methodologically insufficient and provide contradictory results. Ablation therapy for atrial fibrillation in patients with migraine might reduce migraine attacks, but transient post-ablation new-onset migraine-like headaches in persons without a history of migraine have also been reported. CONCLUSION: Population-based studies indicate a significant association of migraine with aura and atrial fibrillation. In practical terms, screening for atrial fibrillation in patients who have a long history of migraine might be reasonable, whereas in patients with stroke or other disorders and migraine extensive screening for atrial fibrillation should be performed as in all patients without migraine.

4.
J Clin Med ; 10(21)2021 Oct 22.
Artigo em Inglês | MEDLINE | ID: mdl-34768391

RESUMO

BACKGROUND: The prevalence of atrial fibrillation (AF) is high in older patients. The present study aimed to estimate the age and sex specific prevalence of clinical and screen-detected atrial fibrillation (AF) in hospitalized patients. METHODS: The STAR-FIB cohort study was a prospective cohort study recruiting participants from a large source population of hospitalized patients aged 65-84 years. The estimated size of the source population was 26,035 (95% CI 25,918-26,152), and 795 consenting patients without clinical AF were included in the cohort study after stratification by sex and age (49.2% females; mean age 74.7 years). Patients in the cohort study underwent three seven-day Holter ECGs in intervals of two months to screen for AF. RESULTS: In the source population, the estimated prevalence of clinical AF was 22.2% (95% CI 18.4-26.1), 23.8% for males (95% CI 20.9-26.6) and 19.8% for females (95% CI 17.3-22.4; p for difference between sexes, 0.004). There was a linear trend for an increase in the prevalence of clinical AF with increasing age, overall and in both sexes. In the cohort study, AF was newly diagnosed in 38 patients, for an estimated prevalence of screen-detected AF of 4.9% overall (95% CI 3.3-6.6), 5.5% in males (95% CI 3.2-7.8) and 4.0% in females (95% CI 2.0-6.0; p for difference between sexes, 0.041). The estimated prevalence of screen-detected AF in the source population was 3.8% overall, 4.2% in males and 3.2% in females. CONCLUSION: In a large hospital-based patient population aged 65-84 years, the prevalence of clinical AF and of screen-detected AF was 22.2% and 3.8%, respectively, and significantly higher in males than females.

5.
Artigo em Inglês | MEDLINE | ID: mdl-34491323

RESUMO

AIMS: Acute kidney injury (AKI) is a critical complication among patients with acute coronary syndrome (ACS) undergoing invasive management. The value of adjunctive antithrombotic strategies, such as bivalirudin or unfractionated heparin (UFH) on the risk of AKI is unclear. METHODS AND RESULTS: Among 7213 patients enrolled in the MATRIX-Antithrombin and Treatment Duration study, 128 subjects were excluded due to incomplete information on serum creatinine (sCr) or end-stage renal disease on dialysis treatment. The primary endpoint was AKI defined as an absolute (>0.5 mg/dL) or a relative (>25%) increase in sCr. AKI occurred in 601 patients (16.9%) treated with bivalirudin and 616 patients (17.4%) treated with UFH [odds ratio (OR): 0.97; 95% confidence interval (CI): 0.85-1.09; P = 0.58]. A >25% sCr increase was observed in 597 patients (16.8%) with bivalirudin and 616 patients (17.4%) with UFH (OR: 0.96; 95% CI: 0.85-1.08; P = 0.50), whereas a >0.5 mg/dL absolute sCr increase occurred in 176 patients (5.0%) with bivalirudin vs. 189 patients (5.4%) with UFH (OR: 0.92; 95% CI: 0.75-1.14; P = 0.46). By implementing the Kidney Disease Improving Global Outcomes (KDIGO) criteria, the risk of AKI was not significantly different between bivalirudin and UFH groups (OR: 0.88; 95% CI: 0.72-1.07; P = 0.21). Subgroup analyses of the primary endpoint suggested a benefit with bivalirudin in patients randomized to femoral access. CONCLUSION: Among ACS patients undergoing invasive management, the risk of AKI was not significantly lower with bivalirudin compared with UFH. TRIAL REGISTRATION: clinicaltrials.gov NCT01433627.

6.
Neurosurgery ; 89(6): 967-972, 2021 Nov 18.
Artigo em Inglês | MEDLINE | ID: mdl-34528089

RESUMO

BACKGROUND: Intrawound vancomycin powder is an emerging strategy to reduce surgical site infections (SSIs) in spine surgery. However, there are concerns relating to its safety profile and toxicity. Data on systemic uptake of suprafascially administered vancomycin powder following instrumented spinal fusion is lacking. OBJECTIVE: To study the systemic uptake and safety of suprafascially administered vancomycin powder in the early postoperative phase following open instrumented posterior spinal fusion. METHODS: This was a substudy of an ongoing randomized clinical trial. Eligible adult patients were randomized 1:1 to either receive suprafascial vancomycin powder before wound closure or not to receive vancomycin powder. Serum vancomycin levels were assessed on postoperative days 1 and 2, serum creatinine levels were measured pre- and post-operatively. Adverse events up to 6 wk following surgery were recorded. RESULTS: Among 34 randomized patients (mean age 62 yr, range 31-84 yr; 18 [53%] women), 17 received vancomycin powder. No detectable serum vancomycin levels (>4.0 mg/L) were found. Proportion of adverse events per patient in the vancomycin and control group, respectively, were 29.4% (5/17) vs 11.8% (2/17) (OR 3.12; 95% CI, 0.52; 19.38; P = .398). No patient had nephrotoxicity or ototoxicity in either group. CONCLUSION: Suprafascial vancomycin powder in open instrumented spinal fusion surgery is safe and results in negligible systemic uptake. Final results of the VANCO Trial need to be awaited for conclusive data on the efficacy of vancomycin for SSI prevention and its impact on wound healing.

7.
EuroIntervention ; 2021 Aug 11.
Artigo em Inglês | MEDLINE | ID: mdl-34374343

RESUMO

BACKGROUND: The radial artery is recommended by international guidelines as the default vascular access in patients with acute coronary syndromes (ACS) managed invasively. However, crossover from radial to femoral access is required in 4-10% of cases and has been associated with worse outcomes. No standardised algorithm exists to predict the risk of radial crossover. AIMS: We sought to derive and externally validate a risk score to predict radial crossover in patients with ACS managed invasively. METHODS: The derivation cohort consisted of 4,197 patients with ACS undergoing invasive management via the randomly allocated radial access from the MATRIX trial. Using logistic regression, we selected predictors of radial crossover and developed a numerical risk score. External validation was accomplished among 3,451 and 491 ACS patients managed invasively and randomised to radial access from the RIVAL and RIFLE-STEACS trials, respectively. RESULTS: The MATRIX score (age, height, smoking, renal failure, prior coronary artery bypass grafting, ST-segment elevation myocardial infarction, Killip class, radial expertise) showed a c-index for radial crossover of 0.71 (95% CI: 0.67-0.75) in the derivation cohort. Discrimination ability was modest in the RIVAL (c-index: 0.64; 95% CI: 0.59-0.67) and RIFLE-STEACS (c-index: 0.66; 95% CI: 0.57-0.75) cohorts. A cut-off of ≥41 points was selected to identify patients at high risk of radial crossover. CONCLUSIONS: The MATRIX score is a simple eight-item risk score which provides a standardised tool for the prediction of radial crossover among patients with ACS managed invasively. This tool can assist operators in anticipating and better addressing difficulties related to transradial procedures, potentially improving outcomes.

8.
Heart Rhythm ; 18(12): 2033-2039, 2021 12.
Artigo em Inglês | MEDLINE | ID: mdl-34411717

RESUMO

BACKGROUND: Impairment of atrioventricular (AV) conduction may occur late after transcatheter aortic valve implantation (TAVI), and progression to complete AV block is a matter of concern. OBJECTIVE: The purpose of this study was to describe the incidence of permanent pacemaker (PPM) implantation late after TAVI. METHODS: In a prospective TAVI registry, we retrospectively identified patients with PPM implantation after hospital discharge for TAVI and analyzed serial electrocardiograms for AV conduction impairment before PPM implantation. RESULTS: Among 1059 patients discharged after TAVI without PPM between January 2012 and December 2017, 62 patients (5.9%) underwent PPM implantation at a median of 305 days after discharge for TAVI. Indications for PPM implantation late after TAVI were AV conduction impairment in 46 patients (74.2%); sick sinus syndrome in 10 (16.1%); cardiac resynchronization or implantable cardioverter-defibrillator indication in 2 (3.2%); and a pace and ablate strategy in 4 (6.5%). Clinical symptoms leading to PPM implantation late after TAVI included syncope in 19 patients (30.7%), presyncope in 7 (11.3%), and dyspnea in 8 (12.9%). First-degree AV block and new left bundle branch block (LBBB) after TAVI as well as valve-in-valve procedure during follow-up were independent predictors of PPM implantation late after TAVI due to AV conduction impairment. CONCLUSION: PPM implantation late after TAVI is infrequent and is associated with clinical symptoms in half of patients. Impairment of AV conduction was the indication in three-quarters of patients. First-degree AV block and new LBBB after TAVI as well as valve-in-valve procedure during follow-up emerged as independent predictors.

9.
BMJ ; 373: n1332, 2021 06 16.
Artigo em Inglês | MEDLINE | ID: mdl-34135011

RESUMO

OBJECTIVE: To assess the risks and benefits of P2Y12 inhibitor monotherapy compared with dual antiplatelet therapy (DAPT) and whether these associations are modified by patients' characteristics. DESIGN: Individual patient level meta-analysis of randomised controlled trials. DATA SOURCES: Searches were conducted in Ovid Medline, Embase, and three websites (www.tctmd.com, www.escardio.org, www.acc.org/cardiosourceplus) from inception to 16 July 2020. The primary authors provided individual participant data. ELIGIBILITY CRITERIA: Randomised controlled trials comparing effects of oral P2Y12 monotherapy and DAPT on centrally adjudicated endpoints after coronary revascularisation in patients without an indication for oral anticoagulation. MAIN OUTCOME MEASURES: The primary outcome was a composite of all cause death, myocardial infarction, and stroke, tested for non-inferiority against a margin of 1.15 for the hazard ratio. The key safety endpoint was Bleeding Academic Research Consortium (BARC) type 3 or type 5 bleeding. RESULTS: The meta-analysis included data from six trials, including 24 096 patients. The primary outcome occurred in 283 (2.95%) patients with P2Y12 inhibitor monotherapy and 315 (3.27%) with DAPT in the per protocol population (hazard ratio 0.93, 95% confidence interval 0.79 to 1.09; P=0.005 for non-inferiority; P=0.38 for superiority; τ2=0.00) and in 303 (2.94%) with P2Y12 inhibitor monotherapy and 338 (3.36%) with DAPT in the intention to treat population (0.90, 0.77 to 1.05; P=0.18 for superiority; τ2=0.00). The treatment effect was consistent across all subgroups, except for sex (P for interaction=0.02), suggesting that P2Y12 inhibitor monotherapy lowers the risk of the primary ischaemic endpoint in women (hazard ratio 0.64, 0.46 to 0.89) but not in men (1.00, 0.83 to 1.19). The risk of bleeding was lower with P2Y12 inhibitor monotherapy than with DAPT (97 (0.89%) v 197 (1.83%); hazard ratio 0.49, 0.39 to 0.63; P<0.001; τ2=0.03), which was consistent across subgroups, except for type of P2Y12 inhibitor (P for interaction=0.02), suggesting greater benefit when a newer P2Y12 inhibitor rather than clopidogrel was part of the DAPT regimen. CONCLUSIONS: P2Y12 inhibitor monotherapy was associated with a similar risk of death, myocardial infarction, or stroke, with evidence that this association may be modified by sex, and a lower bleeding risk compared with DAPT. REGISTRATION: PROSPERO CRD42020176853.


Assuntos
Doença da Artéria Coronariana/tratamento farmacológico , Terapia Antiplaquetária Dupla/efeitos adversos , Intervenção Coronária Percutânea/efeitos adversos , Antagonistas do Receptor Purinérgico P2Y/efeitos adversos , Idoso , Doença da Artéria Coronariana/cirurgia , Terapia Antiplaquetária Dupla/métodos , Feminino , Hemorragia/induzido quimicamente , Hemorragia/epidemiologia , Humanos , Masculino , Pessoa de Meia-Idade , Mortalidade/tendências , Infarto do Miocárdio/epidemiologia , Infarto do Miocárdio/prevenção & controle , Avaliação de Resultados em Cuidados de Saúde , Intervenção Coronária Percutânea/mortalidade , Intervenção Coronária Percutânea/normas , Antagonistas do Receptor Purinérgico P2Y/uso terapêutico , Ensaios Clínicos Controlados Aleatórios como Assunto , Medição de Risco , Acidente Vascular Cerebral/epidemiologia , Acidente Vascular Cerebral/prevenção & controle , Trombose/tratamento farmacológico , Trombose/prevenção & controle
10.
Clin Neuroradiol ; 2021 Jun 25.
Artigo em Inglês | MEDLINE | ID: mdl-34170368

RESUMO

PURPOSE: To assess early renal pelvis opacification on postmyelography computed tomography (CT) as a marker for cerebrospinal fluid (CSF) loss in patients with spontaneous intracranial hypotension (SIH). METHODS: The SIH patients referred to our hospital between January 2012 and May 2018 were retrospectively reviewed and divided into 2 groups based on the presence of spinal longitudinal extrathecal CSF collection (SLEC): (1) SLEC(+) with, and (2) SLEC(-) without proof of SLEC on multimodal imaging. Non-SIH patients (n = 20) undergoing CT myelography served as controls. The renal pelvis density on postmyelography CT was measured in all patients. Mean difference in renal pelvis density between the groups was calculated. RESULTS: In total, 111 SIH patients (mean age 48 ± 13 years; 60% female) were included, 71 (64%) SLEC(+) and 40 (36%) SLEC(-). The adjusted renal pelvis density in the SLEC(+), SLEC(-), and the non-SIH group was 108 Hounsfield unit (HU), 83 HU, and 32 HU, respectively, resulting in a significant difference between SLEC(+) vs. control group 1 (75 HU, p < 0.001), SLEC(-) vs. control group 1 (50 HU, p < 0.001), and a tendency for higher density in SLEC(+) than SLEC(-) (25 HU, p = 0.16). CONCLUSION: Increased renal pelvis opacification on postmyelography CT was observed in SIH patients, even in the absence of a CSF leak or a CSF venous fistula, when compared to non-SIH patients. Although the provenance of early renal opacification in SLEC (-) SIH patients remains unclear, our results suggest that it may be a surrogate for increased spinal CSF resorption via spinal arachnoid granulations and along spinal nerve sheaths occult to direct imaging.

11.
J Neurointerv Surg ; 2021 Apr 28.
Artigo em Inglês | MEDLINE | ID: mdl-33911015

RESUMO

BACKGROUND: The degree of reperfusion is the most important modifiable predictor of 3 month functional outcome and mortality in ischemic stroke patients treated with mechanical thrombectomy. Whether the beneficial effect of reperfusion also leads to a reduction in long term mortality is unknown. METHODS: Patients undergoing mechanical thrombectomy between January 2010 and December 2018 were included. The post-thrombectomy degree of reperfusion and emboli in new territories were core laboratory adjudicated. Reperfusion was evaluated according to the expanded Thrombolysis in Cerebral Infarction (eTICI) scale. Vital status was obtained from the Swiss population register. Adjusted hazard ratios (aHRs) using time split Cox regression models were calculated. Subgroup analyses were performed in patients with borderline indications. RESULTS: Our study included 1264 patients (median follow-up per patient 2.5 years). Patients with successful reperfusion had longer survival times, attributable to a lower hazard of death within 0-90 days and for >90 days to 2 years (aHR 0.34, 95% CI 0.26 to 0.46; aHR 0.37, 95% CI 0.22 to 0.62). This association was homogeneous across all predefined subgroups (p for interaction >0.05). Among patients with successful reperfusion, a significant difference in the hazard of death was observed between eTICI2b50 and eTICI3 (aHR 0.51, 95% CI 0.33 to 0.79). Emboli in new territories were present in 5% of patients, and were associated with increased mortality (aHR 2.3, 95% CI 1.11 to 4.86). CONCLUSION: Successful, and ideally complete, reperfusion without emboli in new territories is associated with a reduction in long term mortality in patients treated with mechanical thrombectomy, and this was evident across several subgroups.

12.
Eur J Prev Cardiol ; 28(1): 59-65, 2021 03 23.
Artigo em Inglês | MEDLINE | ID: mdl-33755142

RESUMO

AIMS: The 2018 American College of Cardiology (ACC)/American Heart Association (AHA) and 2019 European Society of Cardiology (ESC)/European Atherosclerosis Society (EAS) lipid guidelines recently updated their recommendations regarding proprotein convertase subtilisin/kexin-9 inhibitors (PCSK9i). We assessed the potential eligibility for PCSK9i according to the new guidelines in patients with acute coronary syndromes. METHODS AND RESULTS: We analysed a contemporary, prospective Swiss cohort of patients hospitalised for acute coronary syndromes. We modelled a statin intensification effect and an incremental ezetimibe effect on low-density lipoprotein-cholesterol levels among patients who were not on high-intensity statins or ezetimibe. One year after the index acute coronary syndrome event, treatment eligibility for PCSK9i was defined as low-density lipoprotein-cholesterol of 1.4 mmol/l or greater according to ESC/EAS guidelines. For ACC/AHA guidelines, treatment eligibility was defined as low-density lipoprotein-cholesterol of 1.8 mmol/l or greater in the presence of very high-risk atherosclerotic cardiovascular disease, defined by multiple major atherosclerotic cardiovascular disease events and/or high-risk conditions. Of 2521 patients, 93.2% were treated with statins (53% high-intensity statins) and 7.3% with ezetimibe at 1 year, and 54.9% had very high-risk atherosclerotic cardiovascular disease. Low-density lipoprotein-cholesterol levels less than 1.8 mmol/l and less than 1.4 mmol/l at 1 year were observed in 37.5% and 15.7% of patients, respectively. After modelling the statin intensification and ezetimibe effects, these numbers increased to 76.1% and 49%, respectively. The proportion of patients eligible for PCSK9i was 51% according to ESC/EAS criteria versus 14% according to ACC/AHA criteria. CONCLUSIONS: In this analysis, the 2019 ESC/EAS guidelines rendered half of all post-acute coronary syndrome patients potentially eligible for PCSK9i treatment, as compared to a three-fold lower eligibility rate based on the 2018 ACC/AHA guidelines.

13.
Swiss Med Wkly ; 151: w20421, 2021 02 15.
Artigo em Inglês | MEDLINE | ID: mdl-33641108

RESUMO

AIMS OF THE STUDY: Anticoagulation of patients with screen-detected atrial fibrillation may prevent ischaemic strokes. The STAR-FIB study programme aims to determine the age- and sex-specific prevalence of silent atrial fibrillation and to develop a clinical prediction model to identify patients at risk of undiagnosed atrial fibrillation in a hospitalised patient population. METHODS: The STAR-FIB study programme includes a prospective cohort study and a case-control study of hospitalised patients aged 65–84 years, evenly distributed for both age and sex. We recruited 795 patients without atrial fibrillation for the cohort study (49.2% females; median age 74.8 years). All patients had three serial 7-day Holter ECGs to screen for silent atrial fibrillation. The primary endpoint will be any episode of atrial fibrillation or atrial flutter of ≥30 seconds duration. The age- and sex-specific prevalence of newly diagnosed atrial fibrillation will be estimated. For the case-control study, 120 patients with paroxysmal atrial fibrillation were recruited as cases (41.7% females; median age 74.6 years); controls will be randomly selected from the cohort study in a 2:1 ratio. All participants in the cohort study and all cases were prospectively evaluated including clinical, laboratory, echocardiographic and electrical parameters. A clinical prediction model for undiagnosed atrial fibrillation will be derived in the case-control study and externally validated in the cohort study. CONCLUSIONS: The STAR-FIB study programme will estimate the age- and sex-specific prevalence of silent atrial fibrillation in a hospitalised patient population, and develop and validate a clinical prediction model to identify patients at risk of silent atrial fibrillation.


Assuntos
Fibrilação Atrial , Idoso , Fibrilação Atrial/diagnóstico , Fibrilação Atrial/epidemiologia , Estudos de Casos e Controles , Estudos de Coortes , Feminino , Humanos , Masculino , Modelos Estatísticos , Prognóstico , Estudos Prospectivos
14.
JACC Cardiovasc Interv ; 14(4): 361-373, 2021 02 22.
Artigo em Inglês | MEDLINE | ID: mdl-33602431

RESUMO

OBJECTIVES: The aim of this study was to assess the impact of access-site crossover in patients with acute coronary syndrome undergoing invasive management via radial or femoral access. BACKGROUND: There are limited data on the clinical implications of access-site crossover. METHODS: In the MATRIX (Minimizing Adverse Haemorrhagic Events by Transradial Access Site and Systemic Implementation of Angiox)-Access trial, 8,404 patients with acute coronary syndrome were randomized to radial or femoral access. Patients undergoing access-site crossover or successful access site were investigated. Thirty-day coprimary outcomes were a composite of death, myocardial infarction, or stroke (major adverse cardiovascular events [MACE]) and a composite of MACE or Bleeding Academic Research Consortium type 3 or 5 bleeding (net adverse clinical events [NACE]). RESULTS: Access-site crossover occurred in 183 of 4,197 patients (4.4%) in the radial group (mainly to femoral access) and 108 of 4,207 patients (2.6%) in the femoral group (mainly to radial access). In multivariate analysis, the risk for coprimary outcomes was not significantly higher with radial crossover compared with successful radial (MACE: adjusted rate ratio [adjRR]: 1.25; 95% confidence interval [CI]: 0.81 to 1.93; p = 0.32; NACE: adjRR: 1.40; 95% CI: 0.94 to 2.06; p = 0.094) or successful femoral access (MACE: adjRR: 1.17; 95% CI: 0.76 to 1.81; p = 0.47; NACE: adjRR: 1.26; 95% CI: 0.86 to 1.86; p = 0.24). Access site-related Bleeding Academic Research Consortium type 3 or 5 bleeding was higher with radial crossover than successful radial access. Femoral crossover remained associated with higher risks for MACE (adjRR: 1.84; 95% CI: 1.18 to 2.87; p = 0.007) and NACE (adjRR: 1.69; 95% CI: 1.09 to 2.62; p = 0.019) compared with successful femoral access. Results remained consistent after excluding patients with randomized access not attempted. CONCLUSIONS: Crossover from radial to femoral access abolishes the bleeding benefit offered by the radial over femoral artery but does not appear to increase the risk for MACE or NACE compared with successful radial or femoral access. (Minimizing Adverse Haemorrhagic Events by Transradial Access Site and Systemic Implementation of Angiox [MATRIX]; NCT01433627).


Assuntos
Síndrome Coronariana Aguda , Cateterismo Periférico , Intervenção Coronária Percutânea , Síndrome Coronariana Aguda/diagnóstico por imagem , Síndrome Coronariana Aguda/terapia , Cateterismo Periférico/efeitos adversos , Artéria Femoral/diagnóstico por imagem , Humanos , Intervenção Coronária Percutânea/efeitos adversos , Artéria Radial/diagnóstico por imagem , Resultado do Tratamento
15.
Circ Cardiovasc Qual Outcomes ; 14(2): e006581, 2021 02.
Artigo em Inglês | MEDLINE | ID: mdl-33535773

RESUMO

BACKGROUND: Event adjudication by a clinical event committee (CEC) provides a standardized, independent outcome assessment. However, the added value of CEC to investigators reporting remains debated. GLASSY (GLOBAL LEADERS Adjudication Sub-Study) implemented, in a subset of the open-label, investigator-reported (IR) GLOBAL LEADERS trial, an independent adjudication process of reported and unreported potential outcome events (triggers). We describe metrics of GLASSY feasibility and efficiency, diagnostic accuracy of IR events, and their concordance with corresponding CEC-adjudicated events. METHODS: We report the proportion of myocardial infarction, bleeding, stroke, and stent thrombosis triggers with sufficient evidence for assessment (feasibility) that were adjudicated as outcome events (efficiency), stratified by source (IR or non-IR). Using CEC-adjudicated events as criterion standard, we describe sensitivity, specificity, positive and negative predictive value, and global diagnostic accuracy of IR events. Using Gwet AC coefficient, we examine the concordance between IR- and corresponding CEC-adjudicated triggers. There was sufficient evidence for assessment for 2592 (98.3%) of 2636 triggers. RESULTS: Overall, the adjudicated end point-to-trigger ratio was high and similar between IR- (88%) and non-IR-reported (87%) triggers. The global diagnostic accuracy and concordance between IR-reported and CEC-adjudicated outcome events was 0.70 (95% CI, 0.65-0.74) and 0.54 (95% CI, 0.45-0.62), respectively, for myocardial infarction; 0.77 (95% CI, 0.75-0.79) and 0.71 (95% CI, 0.68-0.74) for bleeding; 0.70 (95% CI, 0.62-0.79) and 0.59 (95% CI, 0.43-0.74) for stroke; 0.59 (95% CI, 0.52-0.66) and 0.39 (95% CI, 0.25-0.53) for stent thrombosis. For IR bleedings, the concordance with the CEC on type of events was generally weak. CONCLUSIONS: Implementing CEC adjudication in a pragmatic open-label trial with IR events is feasible and efficient. Our findings of modest global diagnostic accuracy for IR events and generally weak concordance between investigators and CEC support the role for CEC adjudication in such settings. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03231059.


Assuntos
Infarto do Miocárdio , Acidente Vascular Cerebral , Hemorragia , Humanos , Resultado do Tratamento
16.
N Engl J Med ; 384(6): 497-511, 2021 02 11.
Artigo em Inglês | MEDLINE | ID: mdl-33264556

RESUMO

BACKGROUND: World Health Organization expert groups recommended mortality trials of four repurposed antiviral drugs - remdesivir, hydroxychloroquine, lopinavir, and interferon beta-1a - in patients hospitalized with coronavirus disease 2019 (Covid-19). METHODS: We randomly assigned inpatients with Covid-19 equally between one of the trial drug regimens that was locally available and open control (up to five options, four active and the local standard of care). The intention-to-treat primary analyses examined in-hospital mortality in the four pairwise comparisons of each trial drug and its control (drug available but patient assigned to the same care without that drug). Rate ratios for death were calculated with stratification according to age and status regarding mechanical ventilation at trial entry. RESULTS: At 405 hospitals in 30 countries, 11,330 adults underwent randomization; 2750 were assigned to receive remdesivir, 954 to hydroxychloroquine, 1411 to lopinavir (without interferon), 2063 to interferon (including 651 to interferon plus lopinavir), and 4088 to no trial drug. Adherence was 94 to 96% midway through treatment, with 2 to 6% crossover. In total, 1253 deaths were reported (median day of death, day 8; interquartile range, 4 to 14). The Kaplan-Meier 28-day mortality was 11.8% (39.0% if the patient was already receiving ventilation at randomization and 9.5% otherwise). Death occurred in 301 of 2743 patients receiving remdesivir and in 303 of 2708 receiving its control (rate ratio, 0.95; 95% confidence interval [CI], 0.81 to 1.11; P = 0.50), in 104 of 947 patients receiving hydroxychloroquine and in 84 of 906 receiving its control (rate ratio, 1.19; 95% CI, 0.89 to 1.59; P = 0.23), in 148 of 1399 patients receiving lopinavir and in 146 of 1372 receiving its control (rate ratio, 1.00; 95% CI, 0.79 to 1.25; P = 0.97), and in 243 of 2050 patients receiving interferon and in 216 of 2050 receiving its control (rate ratio, 1.16; 95% CI, 0.96 to 1.39; P = 0.11). No drug definitely reduced mortality, overall or in any subgroup, or reduced initiation of ventilation or hospitalization duration. CONCLUSIONS: These remdesivir, hydroxychloroquine, lopinavir, and interferon regimens had little or no effect on hospitalized patients with Covid-19, as indicated by overall mortality, initiation of ventilation, and duration of hospital stay. (Funded by the World Health Organization; ISRCTN Registry number, ISRCTN83971151; ClinicalTrials.gov number, NCT04315948.).


Assuntos
Monofosfato de Adenosina/análogos & derivados , Alanina/análogos & derivados , Antivirais/uso terapêutico , COVID-19/tratamento farmacológico , Hidroxicloroquina/uso terapêutico , Interferon beta-1a/uso terapêutico , Lopinavir/uso terapêutico , Monofosfato de Adenosina/uso terapêutico , Idoso , Alanina/uso terapêutico , Antivirais/administração & dosagem , Antivirais/efeitos adversos , COVID-19/mortalidade , Quimioterapia Combinada , Feminino , Mortalidade Hospitalar , Hospitalização , Humanos , Análise de Intenção de Tratamento , Estimativa de Kaplan-Meier , Tempo de Internação , Masculino , Pessoa de Meia-Idade , Respiração Artificial , Falha de Tratamento
17.
Ann Neurol ; 89(1): 42-53, 2021 01.
Artigo em Inglês | MEDLINE | ID: mdl-32996627

RESUMO

OBJECTIVE: The aim was to evaluate, in patients with atrial fibrillation (AF) and acute ischemic stroke, the association of prior anticoagulation with vitamin K antagonists (VKAs) or direct oral anticoagulants (DOACs) with stroke severity, utilization of intravenous thrombolysis (IVT), safety of IVT, and 3-month outcomes. METHODS: This was a cohort study of consecutive patients (2014-2019) on anticoagulation versus those without (controls) with regard to stroke severity, rates of IVT/mechanical thrombectomy, symptomatic intracranial hemorrhage (sICH), and favorable outcome (modified Rankin Scale score 0-2) at 3 months. RESULTS: Of 8,179 patients (mean [SD] age, 79.8 [9.6] years; 49% women), 1,486 (18%) were on VKA treatment, 1,634 (20%) on DOAC treatment at stroke onset, and 5,059 controls. Stroke severity was lower in patients on DOACs (median National Institutes of Health Stroke Scale 4, [interquartile range 2-11]) compared with VKA (6, [2-14]) and controls (7, [3-15], p < 0.001; quantile regression: ß -2.1, 95% confidence interval [CI] -2.6 to -1.7). The IVT rate in potentially eligible patients was significantly lower in patients on VKA (156 of 247 [63%]; adjusted odds ratio [aOR] 0.67; 95% CI 0.50-0.90) and particularly in patients on DOACs (69 of 464 [15%]; aOR 0.06; 95% CI 0.05-0.08) compared with controls (1,544 of 2,504 [74%]). sICH after IVT occurred in 3.6% (2.6-4.7%) of controls, 9 of 195 (4.6%; 1.9-9.2%; aOR 0.93; 95% CI 0.46-1.90) patients on VKA and 2 of 65 (3.1%; 0.4-10.8%, aOR 0.56; 95% CI 0.28-1.12) of those on DOACs. After adjustments for prognostic confounders, DOAC pretreatment was associated with a favorable 3-month outcome (aOR 1.24; 1.01-1.51). INTERPRETATION: Prior DOAC therapy in patients with AF was associated with decreased admission stroke severity at onset and a remarkably low rate of IVT. Overall, patients on DOAC might have better functional outcome at 3 months. Further research is needed to overcome potential restrictions for IVT in patients taking DOACs. ANN NEUROL 2021;89:42-53.


Assuntos
Anticoagulantes/uso terapêutico , Fibrilação Atrial/complicações , Isquemia Encefálica/complicações , AVC Isquêmico/tratamento farmacológico , Administração Oral , Idoso , Idoso de 80 Anos ou mais , Fibrilação Atrial/tratamento farmacológico , Isquemia Encefálica/tratamento farmacológico , Estudos de Coortes , Feminino , Fibrinolíticos/uso terapêutico , Humanos , AVC Isquêmico/complicações , Masculino , Pessoa de Meia-Idade , Vitamina K/antagonistas & inibidores
18.
Artigo em Inglês | MEDLINE | ID: mdl-32941620

RESUMO

AIMS: The 5-item PRECISE-DAPT, integrating age, haemoglobin, white-blood-cell count, creatinine clearance, and prior bleeding, predicts bleeding risk in patients on dual antiplatelet therapy (DAPT) after stent implantation. We sought to assess whether the bleeding risk prediction offered by the PRECISE-DAPT remains valid among patients receiving ticagrelor monotherapy from 1 month onwards after coronary stenting instead of standard DAPT and having or not having centrally-adjudicated bleeding endpoints. METHODS AND RESULTS: The PRECISE-DAPT was calculated in 14,928 and 7,134 patients from GLOBAL LEADERS and GLASSY trials, respectively. The ability of the score to predict BARC 3 or 5 bleeding was assessed and compared among patients on ticagrelor monotherapy (experimental strategy) or standard DAPT (reference strategy) from 1 month after drug-eluting stent implantation. Bleeding endpoints were investigator-reported or centrally-adjudicated in GLOBAL LEADERS and GLASSY, respectively.At 2 years, the c-indexes for the score among patients treated with the experimental or reference strategy were 0.67 (95% confidence interval [CI]:0.63-0.71) vs. 0.63 (95% CI:0.59-0.67) in GLOBAL LEADERS (p = 0.27), and 0.67 (95% CI:0.61-0.73) vs. 0.66 (95% CI:0.61-0.72) in GLASSY (p = 0.88). Decision curve analysis showed net benefit using the PRECISE-DAPT to guide bleeding risk assessment under both treatment strategies. Results were consistent between investigator-reported and adjudicated endpoints and using the simplified 4-item PRECISE-DAPT. CONCLUSIONS: The PRECISE-DAPT offers a prediction model that proved similarly effective to predict clinically-relevant bleeding among patients on ticagrelor monotherapy from 1 month after coronary stenting compared with standard DAPT and appears to be unaffected by the presence or absence of adjudicated bleeding endpoints.

19.
EuroIntervention ; 16(8): 627-633, 2020 10 23.
Artigo em Inglês | MEDLINE | ID: mdl-32482616

RESUMO

AIMS: The aim of this study was to investigate the effect of ticagrelor monotherapy after one-month dual antiplatelet therapy (DAPT) or conventional DAPT in patients with or without acute coronary syndrome (ACS) in the GLOBAL LEADERS Adjudication Sub-StudY (GLASSY). METHODS AND RESULTS: Risk estimates were expressed as rate ratios (RR) with 95% confidence intervals (CI). A total of 3,840 ACS and 3,745 stable ischaemic heart disease (SIHD) patients were included. At two years, rates of the co-primary efficacy endpoint, a composite of death, myocardial infarction, stroke or urgent target vessel revascularisation, were 7.94% in the experimental and 9.68% in the control group (RR 0.82, 95% CI: 0.66-1.01) among ACS patients and 6.31% in the experimental and 7.14% in the control group (RR 0.89, 95% CI: 0.69-1.13) among SIHD patients (pint=0.63). Trends for lower and higher risk of BARC 3 or 5 bleeding with the experimental strategy in ACS (2.27% vs 3.00%, RR 0.76, 95% CI: 0.51-1.12) and SIHD (2.70% vs 1.96%, RR 1.39, 95% CI: 0.91-2.12) patients, respectively, were observed with significant interaction testing (pint=0.039). A net clinical benefit endpoint, the composite of both co-primary study endpoints, favoured the experimental treatment among ACS patients only. CONCLUSIONS: Ticagrelor monotherapy after one-month DAPT provided consistent treatment effects on ischaemic endpoints in patients with or without ACS but only the former experienced a net clinical benefit. ClinicalTrials.gov identifier: NCT03231059.


Assuntos
Síndrome Coronariana Aguda , Intervenção Coronária Percutânea , Síndrome Coronariana Aguda/tratamento farmacológico , Aspirina/uso terapêutico , Quimioterapia Combinada , Humanos , Inibidores da Agregação Plaquetária/uso terapêutico , Ticagrelor/efeitos adversos , Resultado do Tratamento
20.
J Neurosurg ; 134(3): 1113-1121, 2020 Apr 24.
Artigo em Inglês | MEDLINE | ID: mdl-32330879

RESUMO

OBJECTIVE: With global aging, elective craniotomies are increasingly being performed in elderly patients. There is a paucity of prospective studies evaluating the impact of these procedures on the geriatric population. The goal of this study was to assess the safety of elective craniotomies for elderly patients in modern neurosurgery. METHODS: For this cohort study, adult patients, who underwent elective craniotomies between November 1, 2011, and October 31, 2018, were allocated to 3 age groups (group 1, < 65 years [n = 1008], group 2, ≥ 65 to < 75 [n = 315], and group 3, ≥ 75 [n = 129]). Primary outcome was the 30-day mortality after craniotomy. Secondary outcomes included rate of delayed extubation (> 1 hour), need for emergency head CT scan and reoperation within 48 hours after surgery, length of postoperative intensive or intermediate care unit stay, hospital length of stay (LOS), and rate of discharge to home. Adjustment for American Society of Anesthesiologists Physical Status (ASA PS) class, estimated blood loss, and duration of surgery were analyzed as a comparison using multiple logistic regression. For significant differences a post hoc analysis was performed. RESULTS: In total, 1452 patients (mean age 55.4 ± 14.7 years) were included. The overall mortality rate was 0.55% (n = 8), with no significant differences between groups (group 1: 0.5% [95% binominal CI 0.2%, 1.2%]; group 2: 0.3% [95% binominal CI 0.0%, 1.7%]; group 3: 1.6% [95% binominal CI 0.2%, 5.5%]). Deceased patients had a significantly higher ASA PS class (2.88 ± 0.35 vs 2.42 ± 0.62; difference 0.46 [95% CI 0.03, 0.89]; p = 0.036) and increased estimated blood loss (1444 ± 1973 ml vs 436 ± 545 ml [95% CI 618, 1398]; p <0.001). Significant differences were found in the rate of postoperative head CT scans (group 1: 6.65% [n = 67], group 2: 7.30% [n = 23], group 3: 15.50% [n = 20]; p = 0.006), LOS (group 1: median 5 days [IQR 4; 7 days], group 2: 5 days [IQR 4; 7 days], and group 3: 7 days [5; 9 days]; p = 0.001), and rate of discharge to home (group 1: 79.0% [n = 796], group 2: 72.0% [n = 227], and group 3: 44.2% [n = 57]; p < 0.001). CONCLUSIONS: Mortality following elective craniotomy was low in all age groups. Today, elective craniotomy for well-selected patients is safe, and for elderly patients, too. Elderly patients are more dependent on discharge to other hospitals and postacute care facilities after elective craniotomy. Clinical trial registration no.: NCT01987648 (clinicaltrials.gov).


Assuntos
Craniotomia/efeitos adversos , Procedimentos Cirúrgicos Eletivos/efeitos adversos , Procedimentos Neurocirúrgicos/efeitos adversos , Fatores Etários , Idoso , Idoso de 80 Anos ou mais , Extubação , Perda Sanguínea Cirúrgica , Estudos de Coortes , Craniotomia/mortalidade , Cuidados Críticos/estatística & dados numéricos , Procedimentos Cirúrgicos Eletivos/mortalidade , Feminino , Cabeça/diagnóstico por imagem , Humanos , Tempo de Internação , Masculino , Pessoa de Meia-Idade , Procedimentos Neurocirúrgicos/mortalidade , Complicações Pós-Operatórias/epidemiologia , Complicações Pós-Operatórias/mortalidade , Estudos Prospectivos , Reoperação/estatística & dados numéricos , Tomografia Computadorizada por Raios X , Resultado do Tratamento
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