RESUMEN
AIMS: Fear of physical activity (PA) is discussed as a barrier to regular exercise in patients with heart failure (HF), but HF-specific theoretical concepts are lacking. This study examined associations of fear of PA, heart-focused anxiety and trait anxiety with clinical characteristics and self-reported PA in outpatients with chronic HF. It was also investigated whether personality-related coping styles for dealing with health threats impact fear of PA via symptom perception. METHODS AND RESULTS: This cross-sectional study enrolled 185 HF outpatients from five hospitals (mean age 62 ± 11 years, mean ejection fraction 36.0 ± 12%, 24% women). Avoidance of PA, sports/exercise participation (yes/no) and the psychological characteristics were assessed by self-reports. Fear of PA was assessed by the Fear of Activity in Situations-Heart Failure (FActS-HF15) questionnaire. In multivariable regression analyses higher NYHA class (b = 0.26, p = 0.036) and a higher number of HF drugs including antidepressants (b = 0.25, p = 0.017) were independently associated with higher fear of PA, but not with heart-focused fear and trait anxiety. Of the three anxiety scores only increased fear of PA was independently associated with more avoidance behavior regarding PA (b = 0.45, SE = 0.06, p < 0.001) and with increased odds of no sports/exercise participation (OR = 1.34, 95% CI 1.03-1.74, p = 0.028). Attention towards cardiac symptoms and symptom distress were positively associated with fear of PA (p < 0.001), which explained higher fear of PA in patients with a vigilant (directing attention towards health threats) coping style (p = 0.004). CONCLUSIONS: Fear of PA assessed by the FActS-HF15 is a specific type of anxiety in patients with HF. Attention towards and being distressed by HF symptoms appear to play a central role in fear of PA, particularly in vigilant patients who are used to direct their attention towards health threats. These findings provide approaches for tailored interventions to reduce fear of PA and to increase PA in patients with HF. TRIAL REGISTRATION: ClinicalTrials.gov ID: NCT02898246.
Asunto(s)
Adaptación Psicológica , Ejercicio Físico , Miedo , Insuficiencia Cardíaca , Autoinforme , Anciano , Femenino , Humanos , Masculino , Persona de Mediana Edad , Ansiedad/psicología , Enfermedad Crónica , Estudios Transversales , Ejercicio Físico/psicología , Miedo/psicología , Insuficiencia Cardíaca/psicología , Insuficiencia Cardíaca/fisiopatología , Encuestas y CuestionariosRESUMEN
BACKGROUND: One third of patients undergoing transcatheter aortic-valve implantation (TAVI) have an indication for oral anticoagulation owing to concomitant diseases. Interruption of oral anticoagulation during TAVI may decrease the risk of bleeding, whereas continuation may decrease the risk of thromboembolism. METHODS: We conducted an international, open-label, randomized, noninferiority trial involving patients who were receiving oral anticoagulants and were planning to undergo TAVI. Patients were randomly assigned in a 1:1 ratio to periprocedural continuation or interruption of oral anticoagulation. The primary outcome was a composite of death from cardiovascular causes, stroke from any cause, myocardial infarction, major vascular complications, or major bleeding within 30 days after TAVI. RESULTS: A total of 858 patients were included in the modified intention-to-treat population: 431 were assigned to continuation and 427 to interruption of oral anticoagulation. A primary-outcome event occurred in 71 patients (16.5%) in the continuation group and in 63 (14.8%) in the interruption group (risk difference, 1.7 percentage points; 95% confidence interval [CI], -3.1 to 6.6; P = 0.18 for noninferiority). Thromboembolic events occurred in 38 patients (8.8%) in the continuation group and in 35 (8.2%) in the interruption group (risk difference, 0.6 percentage points; 95% CI, -3.1 to 4.4). Bleeding occurred in 134 patients (31.1%) in the continuation group and in 91 (21.3%) in the interruption group (risk difference, 9.8 percentage points; 95% CI, 3.9 to 15.6). CONCLUSIONS: In patients undergoing TAVI with a concomitant indication for oral anticoagulation, periprocedural continuation was not noninferior to interruption of oral anticoagulation during TAVI with respect to the incidence of a composite of death from cardiovascular causes, stroke, myocardial infarction, major vascular complications, or major bleeding at 30 days. (Funded by the Netherlands Organization for Health Research and Development and the St. Antonius Research Fund; POPular PAUSE TAVI ClinicalTrials.gov number, NCT04437303.).
RESUMEN
BACKGROUND: Transaxillary (TAx) transcatheter aortic valve implantation (TAVI) is a preferred alternative access in patients ineligible for transfemoral TAVI. AIMS: This study used the Trans-AXillary Intervention (TAXI) registry to compare procedural success according to different types of transcatheter heart valves (THV). METHODS: For the TAXI registry anonymized data of patients treated with TAx-TAVI were collected from 18 centers. Acute procedural, early and 1-month clinical outcomes were adjudicated in accordance with standardized VARC-3 definitions. RESULTS: From 432 patients, 368 patients (85.3%, SE group) received self-expanding (SE) THV and 64 patients (14.8%, BE group) received balloon-expandable (BE) THV. Imaging revealed lower axillary artery diameters in the SE group (max/min diameter in mm: 8.4/6.6 vs 9.4/6.8 mm; p < 0.001/p = 0.04) but a higher proportion of axillary tortuosity in BE group (62/368, 23.6% vs 26/64, 42.6%; p = 0.004) with steeper aorta-left ventricle (LV) inflow (55° vs 51°; p = 0.002) and left ventricular outflow tract (LVOT)-LV inflow angles (40.0° vs 24.5°; 0.002). TAx-TAVI was more often conducted by right sided axillary artery in the BE group (33/368, 9.0% vs 17/64, 26.6%; p < 0.001). Device success was higher in the SE group (317/368, 86.1% vs 44/64, 68.8%, p = 0.0015). In logistic regression analysis, BE THV were a risk factor for vascular complications and axillary stent implantation. CONCLUSIONS: Both, SE and BE THV can be safely used in TAx-TAVI. However, SE THV were more often used and were associated with a higher rate of device success. While SE THV were associated with lower rates of vascular complications, BE THV were more often used in cases with challenging anatomical circumstances.
Asunto(s)
Estenosis de la Válvula Aórtica , Prótesis Valvulares Cardíacas , Reemplazo de la Válvula Aórtica Transcatéter , Humanos , Reemplazo de la Válvula Aórtica Transcatéter/métodos , Estenosis de la Válvula Aórtica/cirugía , Resultado del Tratamiento , Válvula Aórtica/cirugía , Sistema de Registros , Diseño de PrótesisRESUMEN
BACKGROUND: Modified balloon angioplasty (MB) using a cutting-/scoring balloon or intravascular lithotripsy (IVL) is used in patients with in-stent restenosis (ISR). However, IVL is an off-label use in this setting. The aim of this subgroup analysis of an all-comers registry was to compare IVL to MB angioplasty in patients with ISR. METHODS: The subgroup (n = 117) included all patients with an ISR treated by MB or IVL between 2019 and 2021. Primary endpoint was strategy success (< 20% residual stenosis). The secondary endpoint was cardiac death, acute myocardial infarction (AMI) and target lesion failure/revascularization (TVR). Quantitative coronary angiography was performed in all patients. RESULTS: A total of n = 36 patients were treated by IVL and n = 81 patients by MB. No significant differences in baseline characteristics were observed between the groups. The primary endpoint was reached in 99 patients (84.6%). Patients in the IVL group had less residual stenosis (2.8% vs. 21.0%; p = 0.012). Multivariate regression analysis revealed that IVL had a significant positive effect on reaching the primary end point (Estimate 2.857; standard error (SE) 1.166; p = 0.014). During the follow-up period (450 days) there were no significant differences in rates of cardiac death (IVL n = 2 (1.7%) vs. MB n = 3 (2.6%); p = 0.643), AMI (IVL n = 2 (1.7%) vs. MB n = 4 (3.4%); p = 0.999) and TVR (IVL n = 5 (4.3%) vs. MB n = 14 (12%); p = 0.851). CONCLUSION: IVL results in a significantly lower rate of residual stenosis than MB in patients with ISR. During the long-term follow-up, no differences in rates of cardiac death, AMI or TVR were observed.
Asunto(s)
Angioplastia Coronaria con Balón , Reestenosis Coronaria , Litotricia , Sistema de Registros , Humanos , Masculino , Femenino , Anciano , Reestenosis Coronaria/etiología , Angioplastia Coronaria con Balón/métodos , Resultado del Tratamiento , Persona de Mediana Edad , Litotricia/métodos , Stents , Angiografía Coronaria , Estudios de Seguimiento , Factores de Tiempo , Estudios RetrospectivosRESUMEN
Background: The aim of this two-center, all-comers registry was to compare the effectiveness and safety of intravascular lithotripsy (IVL) to that of modified balloon angioplasty (MB). MB angioplasty using a cutting or scoring balloon is commonly used in patients with calcified coronary arteries. IVL is a new technology for lesion preparation. This is the first study to compare MB with IVL. Methods: The cohort included all patients treated by MB angioplasty or IVL between 2019 and 2021. The primary endpoint was strategy success (<20% residual stenosis). The secondary endpoint was long-term safety outcomes [cardiac death, acute myocardial infarction (AMI), target lesion failure/revascularization (TVR)]. Quantitative coronary angiography (QCA) was performed in all patients. Primary and secondary endpoints were compared using inverse probability of treatment weighting (IPTW) for treatment effect estimation. Results: A total of n = 86 patients were treated by IVL and n = 92 patients by MB angioplasty. The primary endpoint was reached in 152 patients (85.4%). Patients in the IVL group had less residual stenosis (5.8% vs. 22.8%; p = 0.001) in QCA. Weighted multivariable regression analysis revealed that IVL had a significant positive effect on reaching the primary endpoint of strategy success [odds ratio (OR) 24.58; 95% confidence interval (95% CI) 7.40-101.86; p = 0.001]. In addition, severe calcification was shown to result in a lower probability of achieving the primary endpoint (OR 0.08; 95% CI 0.02-0.24; p = 0.001). During the follow-up period (450 days) there was no difference in cardiovascular mortality rate [IVL (n = 5) 2.8% vs. MB (n = 3) 1.7%; p = 0.129]. Patients with unstable angina at the time of the index procedure had the highest probability of cardiovascular death [hazard ratio (HR) 7.136; 95% CI 1.248-40.802; p = 0.027]. No differences were found in long-term rates of AMI (IVL 1.7% vs. MB 2.8%; p = 0.399; IVL HR 2.73; 95% CI 0.4-17.0; p = 0.281) or TVR (IVL 5.6% vs. MB 9%; p = 0.186; IVL HR 0.78; 95% CI 0.277-2.166; p = 0.626). Conclusion: IVL leads to a significantly better angiographic intervention outcome compared to MB angioplasty in our cohort. During long-term follow-up, no differences in cardiovascular mortality, rate of acute myocardial infarction, or target lesion failure/revascularization were observed.
RESUMEN
BACKGROUND: Stroke remains a feared complication associated with transcatheter aortic valve implantation (TAVI). Embolic cerebral injury occurs in the majority of TAVI cases and can lead to cognitive dysfunction. AIMS: The PROTEMBO C Trial evaluated the safety and performance of the ProtEmbo Cerebral Protection System in TAVI patients. METHODS: Forty-one patients were enrolled in this single-arm study conducted at 8 European centres. The primary safety endpoint was the rate of VARC 2-defined major adverse cardiac and cerebrovascular events (MACCE) at 30 days; the primary performance endpoint was the composite rate of technical success versus performance goals (PG). Secondary endpoints included brain diffusion-weighted magnetic resonance imaging (DW-MRI), new lesion volume, and the rate of death or all strokes compared to historical data. RESULTS: Thirty-seven of 41 enrolled patients underwent TAVI with the ProtEmbo device (intention-to-treat [ITT] population). Both primary endpoints were met. MACCE at 30 days was 8.1% (upper limit of the 95% confidence interval [CI]: 21.3% vs PG 25%; p=0.009), and technical success was 94.6% (lower limit of the 95% CI: 82.3% vs PG 75%; p=0.003). New DW-MRI lesion volumes with ProtEmbo were smaller than in historical data, and 87% of patients completing MRI follow-up had no single lesion >150 mm3. There was 1 stroke in a patient in whom the device was removed prematurely before TAVI completion. CONCLUSIONS: The PROTEMBO C Trial met its primary safety and performance endpoints compared to prespecified historical PGs. Patients had smaller brain lesion volumes on DW-MRI compared to prior series and no larger single lesions. These results warrant further evaluation of the ProtEmbo in a larger randomised controlled trial (RCT).
Asunto(s)
Dispositivos de Protección Embólica , Reemplazo de la Válvula Aórtica Transcatéter , Imagen de Difusión por Resonancia Magnética , Dispositivos de Protección Embólica/efectos adversos , Humanos , Embolia Intracraneal/etiología , Embolia Intracraneal/prevención & control , Accidente Cerebrovascular/etiología , Accidente Cerebrovascular/prevención & control , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Reemplazo de la Válvula Aórtica Transcatéter/instrumentación , Resultado del TratamientoRESUMEN
BACKGROUND: Transcatheter aortic valve implantation (TAVI) is an established management strategy for severe aortic valve stenosis. Percutaneous axillary approach for TAVI holds the promise of improving safety without jeopardizing effectiveness in comparison to surgical access. We aimed at appraising the comparative effectiveness of percutaneous vs. surgical axillary approaches for TAVI. METHODS: We performed an international retrospective observational study using de-identified details on baseline, procedural, and 1-month follow-up features. Valve Academic Research Consortium (VARC)-3 criteria were applied throughout. Outcomes of interest were clinical events up to 1 month of follow-up, compared with unadjusted and propensity score-adjusted analyses. RESULTS: A total of 432 patients were included, 189 (43.8%) receiving surgical access, and 243 (56.2%) undergoing percutaneous access. Primary hemostasis failure was more common in the percutaneous group (13.2% vs. 4.2%, P<0.001), leading to more common use of covered stent implantation (13.2% vs. 3.7%, P<0.001). Irrespectively, percutaneous access was associated with shorter hospital stay (-2.6 days [95% confidence interval: -5.0; -0.1], P=0.038), a lower risk of major adverse events (a composite of death, myocardial infarction, stroke, type 3 bleeding, and major access-site related complication; odds ratio=0.44 [0.21; 0.95], P=0.036), major access-site non-vascular complications (odds ratio=0.21 [0.06; 0.77], P=0.018), and brachial plexus impairment (odds ratio=0.16 [0.03; 0.76], P=0.021), and shorter hospital stay (-2.6 days [-5.0; -0.1], P=0.038). CONCLUSIONS: Percutaneous axillary access provides similar or better results than surgical access in patients undergoing TAVI with absolute or relative contraindications to femoral access.
Asunto(s)
Estenosis de la Válvula Aórtica , Reemplazo de la Válvula Aórtica Transcatéter , Humanos , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Reemplazo de la Válvula Aórtica Transcatéter/métodos , Resultado del Tratamiento , Estenosis de la Válvula Aórtica/cirugía , Estenosis de la Válvula Aórtica/etiología , Sistema de Registros , Estudios Retrospectivos , Válvula Aórtica/cirugía , Factores de RiesgoRESUMEN
To evaluate the cost-saving of a specialized, eHealth-based management service (CS) in comparison to regular medical care (RMC) for the management of patients receiving oral anticoagulation (OAC) therapy. Costs of hospitalization were derived via diagnosis-related groups which comprise diagnoses (ICD-10) and operation and procedure classification system (OPS), which resulted in OAC-related (i.e. bleeding/ thromboembolic events) and non-OAC-related costs for both cohorts. Cost for anticoagulation management comprised INR-testing, personnel, and technical support. In total, 705 patients were managed by CS and 1490 patients received RMC. The number of hospital stays was significantly lower in the CS cohort compared to RMC (CS: 23.4/100 py; RMC: 68.7/100 py); with the most pronounced difference in OAC-related admissions (CS: 2.8/100 py; RMC: 13.3/100 py). Total costs for anticoagulation management amounted to 101 EUR/py in RMC and 311 EUR/py in CS, whereas hospitalization costs were 3261 [IQR 2857-3689] EUR/py in RMC and 683 [504-874] EUR/py in CS. This resulted in an overall cost saving 2368 EUR/py favoring the CS. The lower frequency of adverse events in anticoagulated patients managed by the telemedicine-based CS compared to RMC translated into a substantial cost-saving, despite higher costs for the specialized management of patients.Trial registration: ClinicalTrials.gov, unique identifier NCT01809015, March 8, 2013.
RESUMEN
AIMS: Although depressive symptoms are highly prevalent in patients receiving oral anticoagulation (OAC), the relevance of depression for the outcome of anticoagulated individuals is unknown. METHODS AND RESULTS: We analysed data from the multicentre cohort study thrombEVAL (NCT01809015) investigating the efficacy of OAC with vitamin K antagonists. There was an independent study monitoring, and an independent review panel assessed the endpoints. Out of n = 1558 participants, information about depressive symptoms, as measured by the two-item screener of the patient health questionnaire (PHQ-2), was available in n = 1405 individuals. The mean follow-up period was 28.04 months, with a standard deviation of 11.52 months. In multivariable Cox regression analysis, baseline PHQ-2 sum score was a strong and robust predictor of clinically relevant bleeding [hazard ratio (HR) 1.13, 95% confidence interval 1.03-1.24; P = 0.011] and all-cause mortality (HR 1.18, 1.08-1.28; P = 0.001) independent of age, sex, high school graduation, partnership, clinical profile, intake of serotonin reuptake inhibitors, and quality of OAC therapy. Individuals with clinically significant depressive symptoms (PHQ-2 ≥ 3) had a 57% increased risk for clinically relevant bleeding (fully adjusted HR 1.57, 1.08-2.28) and 54% greater risk for death (fully adjusted HR 1.54, 1.09-2.17). There was no association of depressive symptoms with thromboembolic events. For hospitalization, individuals with depressive symptoms (PHQ-2 ≥ 3) did not experience an elevated risk in the fully adjusted model (HR 1.08, 0.86-1.35; P = 0.52). CONCLUSION: Assessment of depression by the PHQ-2 provided independent long-term prognostic information beyond common biomedical risk factors. These findings highlight the need for targeting depressive symptoms in the management of patients receiving OAC therapy.
Asunto(s)
Depresión , Tromboembolia , Anticoagulantes/efectos adversos , Estudios de Cohortes , Depresión/diagnóstico , Depresión/tratamiento farmacológico , Depresión/epidemiología , Humanos , Tromboembolia/diagnóstico , Tromboembolia/epidemiología , Tromboembolia/prevención & control , Vitamina KRESUMEN
Venous thromboembolism (VTE) is a life-threatening disease with risk of recurrence. Oral anticoagulation (OAC) with vitamin K antagonists (VKA) is effective to prevent thromboembolic recurrence. We aimed to investigate the quality of OAC of VTE patients in regular medical care (RMC) compared to a telemedicine-based coagulation service (CS). The thrombEVAL study (NCT01809015) is a prospective, multi-center study to investigate OAC treatment (recruitment: January 2011-March 2013). Patients were evaluated using clinical visits, computer-assisted personal interviews, self-reported data and laboratory measurements according to standard operating procedures. Overall, 360 patients with VTE from RMC and 254 from CS were included. Time in therapeutic range (TTR) was higher in CS compared to RMC (76.9% (interquartile range [IQR] 63.2-87.1%) vs. 69.5% (52.3-85.6%), p < 0.001). Crude rate of thromboembolic events (rate ratio [RR] 11.33 (95% confidence interval [CI] 1.85-465.26), p = 0.0015), clinically relevant bleeding (RR 6.80 (2.52-25.76), p < 0.001), hospitalizations (RR 2.54 (1.94-3.39), p < 0.001) and mortality under OAC (RR 5.89 (2.40-18.75), p < 0.001) were consistently higher in RMC compared with CS. Patients in RMC had higher risk for primary outcome (clinically relevant bleedings, thromboembolic events and mortality, hazard ratio [HR] 5.39 (95%CI 2.81-10.33), p < 0.0001), mortality (HR 5.54 (2.22-13.84), p = 0.00025), thromboembolic events (HR 6.41 (1.51-27.24), p = 0.012), clinically relevant bleeding (HR 5.31 (1.89-14.89), p = 0.0015) and hospitalization (HR 1.84 (1.34-2.55), p = 0.0002). Benefits of CS care were still observed after adjusting for comorbidities and TTR. In conclusion, anticoagulation quality and outcome of VTE patients undergoing VKA treatment was significantly better in CS than in RMC. Patients treated in CS had lower rates of adverse events, hospitalizations and lower mortality. CS was prognostically relevant, beyond providing advantages of improved international ratio (INR) monitoring.
RESUMEN
Oral anticoagulation (OAC) is effective at preventing and treating thromboses and thromboembolism in patients with normal renal function. We aimed to research the impact of severe renal failure (RF) on patient outcome and to determine the potential benefit of caring for these patients in a specialized coagulation service (CS). A total of 1516 usual medical care patients and 756 CS-managed patients of the thrombEVAL multicenter (21 centers), prospective, cohort study (NCT01809015) were analyzed in a 3-year follow-up. Patients with RF (serum creatinine >3 mg/dL, no renal replacement therapy) were compared to patients without RF in usual care and a CS. The fluctuations in the international normalized ratios were significantly lower in CS-managed patients, and regardless of treatment in usual care or a CS, the time in therapeutic range was significantly lower in RF patients. Cox regression-adjusted hazard ratios for long-term outcome (1.5, 95% CI: 1.22-1.83, p < 0.001), death (1.62, CI: 1.27-2.08, p < 0.001), and hospitalization (1.21, CI: 1.02-1.44, p = 0.032) were significantly higher in RF patients in usual care. Furthermore, there was a trend of more bleeding events in RF patients. CS-treated patients had significantly lower adjusted hazard ratios for death (0.24, CI: 0.14-0.39, p < 0.001), hospitalizations (0.41, CI: 0.34-0.5, p < 0.001), clinically relevant bleeding (0.29, CI: 0.18-0.47, p < 0.001), and major bleeding (0.33, CI: 0.18-0.59, p < 0.001). Thus, patients who required oral anticoagulation therapy benefitted significantly from being managed in a specialized coagulation service, regardless of their renal function.
Asunto(s)
Sobredosis de Droga , Torsades de Pointes , Antagonistas Adrenérgicos beta , Adulto , Antiarrítmicos , Humanos , SotalolRESUMEN
In contrast to overanticoagulation, evidence on risk factors and outcome of subtherapeutic oral anticoagulation (OAC) with vitamin K-antagonists (VKAs) under optimum care is limited. We investigated the clinical phenotype, anticoagulation control, and clinical outcome of 760 VKA patients who received OAC therapy by a specialized coagulation service in the thrombEVAL study (NCT01809015). During 281,934 treatment days, 278 patients experience ≥ 1 episode of subtherapeutic anticoagulation control and had lower quality of OAC therapy compared to 482 patients without subtherapeutic international normalized ratio: 67.6%, interquartile range (IQR) 54.9%/76.8% versus 81.0%, IQR 68.5%/90.4%; p < 0.001. In Cox regression analysis with adjustment for age, sex, cardiovascular risk factors, comorbidities, and treatment characteristics, female sex (hazard ratio [HR], 1.4, 95% confidence interval [CI], 1.0/1.9; p = 0.03), diabetes (HR, 1.4, 95% CI, 1.0/2.0; p = 0.03), and living alone (HR, 1.5, 95% CI, 1.1/2.1; p = 0.009) were independent risk factors of subtherapeutic anticoagulation control, whereas atrial fibrillation (HR, 0.6, 95% CI, 0.4/0.9; p = 0.02) and self-management of OAC therapy (HR, 0.2, 95% CI, 0.1/0.6; p = 0.001) were protective. In addition, active smoking (HR, 1.7, 95% CI, 0.9/3.0; p = 0.086) and living in a nursing home (HR, 1.6, 95% CI, 0.8/3.2; p = 0.15) indicated an elevated risk at the borderline of statistical significance. For the prediction of recurrent subtherapeutic anticoagulation, living alone was the only independent risk factor (HR, 1.7, 95% CI, 1.1/2.5; p = 0.013). The present study suggests that women, diabetics, and patients living alone experience an increased risk of low-quality VKA therapy and might potentially benefit from treatment with direct-acting anticoagulants.
Asunto(s)
Anticoagulantes/uso terapéutico , Coagulación Sanguínea/efectos de los fármacos , Hematología/organización & administración , Terapia Trombolítica/métodos , Vitamina K/antagonistas & inhibidores , Administración Oral , Anciano , Anciano de 80 o más Años , Anticoagulantes/administración & dosificación , Fibrilación Atrial/tratamiento farmacológico , Estudios de Casos y Controles , Comorbilidad , Femenino , Fibrinolíticos/uso terapéutico , Estudios de Seguimiento , Humanos , Relación Normalizada Internacional , Masculino , Persona de Mediana Edad , Fenotipo , Modelos de Riesgos Proporcionales , Control de Calidad , Recurrencia , Factores de Riesgo , Resultado del TratamientoRESUMEN
Beta-blocker overdose is potentially harmful due to the strong blood pressure-lowering and heart rate-lowering effects. However, conflicting data exist as to their differential toxicity, single-substance exposures and the effect of co-exposure with additional antihypertensive medication. For this, a 10-year retrospective, explorative analysis of the Mainz Poison Center/Germany database with regard to circumstances of beta-blocker exposure, doses, symptoms and treatment was carried out. Analyses were restricted to adult patients with single-substance exposures and co-exposures with one additional antihypertensive substance. Written follow-up information was obtained in half the cases. A total of 2967 cases were analysed, of which 697 were single-substance exposures. Metoprolol was most frequently reported followed by bisoprolol, atenolol, propranolol and sotalol. Metoprolol showed a linear dose-symptom relationship, whereas propranolol and sotalol seemed to have a threshold dose beyond which symptoms aggravated. Symptoms did not differ substantially, except for more seizures being reported with propranolol, and more CNS depression/vomiting with sotalol. Activated charcoal was used in 38%, gastric lavage in 11%, temporary pacemaker in 3%, glucagon in 1%, intubation for respiratory insufficiency and cardiopulmonary resuscitation in 1% and 0.5%. All patients recovered. In 174 co-exposure cases, the distribution of poisoning severity and rate of worsening of symptoms was comparable with single-substance exposures except one patient deceased after bisoprolol and verapamil co-exposure. In adults with beta-blocker overdose, no significant differences in poisoning severity among beta-blockers were detected, and no fatalities were observed with single-substance exposures. Co-exposures with other antihypertensives, sedatives or alcohol should be carefully attended to as fatalities might occur.
Asunto(s)
Antagonistas Adrenérgicos beta/envenenamiento , Sobredosis de Droga/epidemiología , Antagonistas Adrenérgicos beta/administración & dosificación , Adulto , Anciano , Carbón Orgánico/administración & dosificación , Relación Dosis-Respuesta a Droga , Sobredosis de Droga/etiología , Sobredosis de Droga/terapia , Femenino , Lavado Gástrico/estadística & datos numéricos , Alemania/epidemiología , Humanos , Masculino , Persona de Mediana Edad , Centros de Control de Intoxicaciones/estadística & datos numéricos , Estudios Retrospectivos , Índice de Severidad de la Enfermedad , Resultado del TratamientoRESUMEN
BACKGROUND: Although polypharmacy is associated with a negative clinical outcome in various settings and commonly observed in patients receiving oral anticoagulation therapy, evidence on the relevance for the clinical outcome of anticoagulated patients is currently limited. The aim of the study was to investigate the effect of polypharmacy on the clinical outcomes among patients taking phenprocoumon. DESIGN: Prospective cohort study. SETTING: Regular medical care. PARTICIPANTS: Information on 2011 individuals receiving vitamin K antagonists was available for analysis from the prospective multicenter thrombEVAL study. MEASUREMENTS: Data were obtained from clinical visits, computer-assisted interviews, and laboratory measurements. Information on clinical outcome was obtained during a 3-year follow-up period and subsequently validated via medical records. RESULTS: The prevalence of polypharmacy (five drugs or more) was 84.1% (n = 1691). Quality of anticoagulation therapy assessed by time in therapeutic range was lower in individuals on five to eight drugs and nine drugs or more (70.7% and 64.7%, respectively) compared with subjects without polypharmacy (73.4%). In addition, a significantly higher variability of international normalized ratio measurements was found in the presence of polypharmacy. The cumulative incidence of bleeding, hospitalization, and all-cause mortality, but not for thromboembolic events, increased across groups of medication. In adjusted Cox regression analysis, polypharmacy is an independent risk factor for bleeding (hazard ratio [HR]≥ 9 drugs vs 1-4 drugs = 1.62; 95% confidence interval [CI] = 1.04-2.52; p = .033); hospitalization (HR≥ 9 drugs vs 1-4 drugs = 1.60; 95% CI = 1.26-2.03; p < .001; and all-cause mortality (HR≥ 9 drugs vs 1-4 drugs = 2.16; 95% CI = 1.43-3.27; p < .001) in a dose-dependent relationship. Per additional drug, bleeding risk was increased by 4%. CONCLUSIONS: Polypharmacy influences the quality of anticoagulation therapy and translates into an elevated risk of adverse events in anticoagulated patients. This suggests that additional medication intake in such patients should be critically reviewed by physicians, and it highlights the importance of initiating investigations aimed at reducing multiple medication intake. J Am Geriatr Soc 67:463-470, 2019.
Asunto(s)
Anticoagulantes , Hemorragia , Afecciones Crónicas Múltiples , Polifarmacia , Vitamina K/antagonistas & inhibidores , Administración Oral , Anciano , Anticoagulantes/farmacocinética , Anticoagulantes/uso terapéutico , Estudios de Cohortes , Interacciones Farmacológicas , Monitoreo de Drogas/métodos , Monitoreo de Drogas/estadística & datos numéricos , Femenino , Alemania/epidemiología , Hemorragia/inducido químicamente , Hemorragia/epidemiología , Hospitalización/estadística & datos numéricos , Humanos , Relación Normalizada Internacional/estadística & datos numéricos , Masculino , Mortalidad , Afecciones Crónicas Múltiples/tratamiento farmacológico , Afecciones Crónicas Múltiples/mortalidad , Prevalencia , Estudios Prospectivos , Factores de RiesgoRESUMEN
Patients with heart failure (HF) are frequently anti-coagulated with vitamin K-antagonists (VKAs). The use of long-acting VKA may be preferable for HF patients due to higher stability of plasma concentrations. However, evidence on phenprocoumon-based oral anti-coagulation (OAC) therapy in HF is scarce. The aim of this study was to assess the impact of the presence of HF on quality of phenprocoumon-based OAC and the subsequent clinical outcome. Quality of OAC therapy and the incidence of adverse events were analysed in a cohort of regular care (n = 2,011) from the multi-centre thrombEVAL study program (NCT01809015) stratified by the presence of HF. To assess the modifiability of outcome, results were compared with data from individuals receiving specialized care for anti-coagulation (n = 760). Overall, the sample comprised of 813 individuals with HF and 1,160 subjects without HF in the regular care cohort. Quality of OAC assessed by time in therapeutic range (TTR) was 66.1% (47.8%/82.8%) for patients with HF and 70.6% (52.1%/85.9%) for those without HF (p = 0.0046). Stratification for New York Heart Classification (NYHA)-class demonstrated a lower TTR with higher NYHA classes: TTRNYHA-I 69.6% (49.4%/85.6%), TTRNYHA-II 66.5% (50.1%/82.9%) and TTRNYHA-≥III 61.8% (43.1%/79.9%). This translated into a worse net clinical benefit outcome for HF (hazard ratio [HR] 1.63 [1.31/2.02]; p < 0.0001) and an increased risk of bleeding (HR 1.40 [1.04/1.89]; p = 0.028). Management in a specialized coagulation service resulted in an improvement of all, TTR (∆+12.5% points), anti-coagulation-specific and non-specific outcome of HF individuals. In conclusion, HF is an independent risk factor for low quality of OAC therapy translating into an increased risk for adverse events, which can be mitigated by specialized care.
Asunto(s)
Anticoagulantes/uso terapéutico , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos/epidemiología , Insuficiencia Cardíaca/tratamiento farmacológico , Hemorragia/epidemiología , Fenprocumón/uso terapéutico , Administración Oral , Anciano , Anciano de 80 o más Años , Anticoagulantes/efectos adversos , Estudios de Cohortes , Femenino , Alemania/epidemiología , Insuficiencia Cardíaca/epidemiología , Hemorragia/etiología , Humanos , Incidencia , Masculino , Fenprocumón/efectos adversos , Estudios Prospectivos , Riesgo , Resultado del TratamientoRESUMEN
BACKGROUND: Oral anticoagulation therapy in individuals with atrial fibrillation (AF) reduces the risk of thromboembolic events at cost of an increased bleeding risk. Whether anticoagulation-related outcomes differ between patients with paroxysmal and sustained AF receiving anticoagulation is controversially discussed. METHODS: In the present analysis of the prospective multi-center cohort study thrombEVAL, the incidence of anticoagulation-related adverse events was analyzed according to the AF phenotype. Information on outcome was centrally recorded over 3 years, validated via medical records and adjudicated by an independent review panel. Study monitoring was provided by an independent institution. RESULTS: Overall, the sample comprised 1089 AF individuals, of whom n = 398 had paroxysmal AF and n = 691 experienced sustained AF. In Cox regression analysis with adjustment for potential confounders, sustained AF indicated an independently elevated risk of clinically relevant bleeding compared to paroxysmal AF [hazard ratio (HR) 1.40 (1.02; 1.93); P = 0.038]. For clinically relevant bleeding, a significant interaction of the pattern of AF type with concomitant heart failure (HF) was detected: HRHF 2.45 (1.51, 3.98) vs. HRno HF 0.85 (0.55, 1.34); Pinteraction = 0.003. In HF patients, sustained AF indicated also an elevated risk of major bleeding [HR 2.25 (1.26, 4.20); P = 0.006]. A simplified HAS-BLED score incorporating only information on age (> 65 years), bleeding history, and HF with sustained AF demonstrated better discriminative performance for clinically relevant bleeding than the original version: AUCHAS-BLED: 0.583 vs. AUCsimplifiedHAS-BLED: 0.642 (P = 0.004). CONCLUSIONS: In HF patients receiving oral anticoagulation, sustained AF indicates a substantially elevated risk of bleeding. CLINICAL TRIAL REGISTRATION: https://clinicaltrials.gov , identifier: NCT01809015.
Asunto(s)
Anticoagulantes/administración & dosificación , Fibrilación Atrial/tratamiento farmacológico , Insuficiencia Cardíaca/complicaciones , Hemorragia/inducido químicamente , Administración Oral , Anciano , Anciano de 80 o más Años , Anticoagulantes/efectos adversos , Fibrilación Atrial/complicaciones , Fibrilación Atrial/fisiopatología , Estudios de Cohortes , Femenino , Hemorragia/epidemiología , Humanos , Incidencia , Masculino , Modelos de Riesgos Proporcionales , Estudios Prospectivos , Análisis de Regresión , Factores de Riesgo , Tromboembolia/prevención & controlRESUMEN
OBJECTIVES: The aim of this study was to assess the 1-year outcome after transcatheter aortic valve replacement (TAVR) of the Direct Flow Medical (DFM) valve in patients with severe symptomatic aortic stenosis who were contraindicated or high risk for surgery. BACKGROUND: The DFM transcatheter heart valve is a new-generation, nonmetallic aortic valve with a pressurized support structure and conformable double-ring annular sealing delivered through an 18-F sheath. The device allows repositioning, retrieval, and assessment of valve performance before permanent implantation. METHODS: A prospective multicenter European registry was set up to determine the safety and performance of the valve in 100 consecutive patients (10 centers). Echocardiographic and angiographic data were evaluated by an independent core laboratory, and adverse events were adjudicated by a clinical events committee using Valve Academic Research Consortium criteria. RESULTS: Patients were 83.1 ± 5.9 years of age and had a logistic EuroSCORE of 22.5 ± 11.3% and a Society of Thoracic Surgeons score of 9.7 ± 8.7%. Correct valve positioning was obtained in 99% of cases with a combined 30-day safety endpoint at 10%, including major stroke in 5.0%, major vascular complications in 2.0%, and death in 1%. At 12 months, 95% of patients were in New York Heart Association functional class I or II. Freedom from any death was 90%, and freedom from any death or major stroke was 85%. Echocardiography demonstrated none/trace to mild aortic regurgitation in 100% of patients and an unchanged mean aortic gradient of 12.2 ± 6.6 mm Hg and effective orifice area of 1.6 ± 0.4 cm(2). CONCLUSIONS: At 1 year, the DFM transcatheter heart valve had durable hemodynamics. This study demonstrates that the low rate of early complications and the low risk of significant aortic regurgitation translated into midterm clinical benefit.
Asunto(s)
Estenosis de la Válvula Aórtica/terapia , Válvula Aórtica/fisiopatología , Bioprótesis , Cateterismo Cardíaco/instrumentación , Implantación de Prótesis de Válvulas Cardíacas/instrumentación , Prótesis Valvulares Cardíacas , Hemodinámica , Anciano , Anciano de 80 o más Años , Válvula Aórtica/diagnóstico por imagen , Insuficiencia de la Válvula Aórtica/etiología , Insuficiencia de la Válvula Aórtica/fisiopatología , Estenosis de la Válvula Aórtica/diagnóstico , Estenosis de la Válvula Aórtica/mortalidad , Estenosis de la Válvula Aórtica/fisiopatología , Cateterismo Cardíaco/efectos adversos , Cateterismo Cardíaco/mortalidad , Supervivencia sin Enfermedad , Europa (Continente) , Femenino , Implantación de Prótesis de Válvulas Cardíacas/efectos adversos , Implantación de Prótesis de Válvulas Cardíacas/mortalidad , Humanos , Estimación de Kaplan-Meier , Modelos Logísticos , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Diseño de Prótesis , Radiografía , Sistema de Registros , Medición de Riesgo , Factores de Riesgo , Índice de Severidad de la Enfermedad , Accidente Cerebrovascular/etiología , Factores de Tiempo , Resultado del Tratamiento , UltrasonografíaRESUMEN
X-ray radiation exposure is of great concern for patients undergoing structural heart interventions. In addition, a larger group of medical staff is required and exposed to radiation compared with percutaneous coronary interventions. This study aimed at quantifying radiation dose reduction with implementation of specific image noise reduction technology (NRT) in transcatheter aortic valve implantation (TAVI) procedures. We retrospectively analyzed 104 consecutive patients with TAVI procedures, 52 patients before and 52 after optimization of x-ray radiation chain, and implementation of NRT. Patients with 1-step TAVI and complex coronary intervention, or complex TAVI procedures, were excluded. Before the procedure, all patients received a multislice computed tomography scan, which was used to size aortic annulus, select the optimal implantation plane, valve type and size, and guide valve implantation using a software tool. Air kerma and kerma-area product were compared in both groups to determine patient radiation dose reduction. Baseline parameters, co-morbidity, or procedural data were comparable between groups. Mean kerma-area product was significantly lower (p <0.001) in the NRT group compared with the standard group (60 ± 39 vs 203 ± 106 Gy × cm(2), p <0.001), which corresponds to a reduction of 70%. Mean air kerma was reduced by 64% (494 ± 360 vs 1,355 ± 657 mGy, p <0.001). In conclusion, using optimized x-ray chain combined with specific image noise reduction technology has the potential to significantly reduce by 2/3 radiation dose in standard TAVI procedures without worsening image quality or prolonging procedure time.