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BACKGROUND AND AIMS: There is significant potential to streamline the clinical pathway for patients undergoing transcatheter aortic valve implantation (TAVI). The purpose of this study was to evaluate the effect of implementing BENCHMARK best practices on the efficiency and safety of TAVI in 28 sites in 7 European countries. METHODS: This was a study of patients with severe symptomatic aortic stenosis (AS) undergoing TAVI with balloon-expandable valves before and after implementation of BENCHMARK best practices. Principal objectives were to reduce hospital length of stay (LoS) and duration of intensive care stay. Secondary objective was to document patient safety. RESULTS: Between January 2020 and March 2023, 897 patients were documented prior to and 1491 patients after the implementation of BENCHMARK practices. Patient characteristics were consistent with a known older TAVI population and only minor differences. Mean LoS was reduced from 7.7 ± 7.0 to 5.8 ± 5.6 days (median 6 vs. 4 days; P < .001). Duration of intensive care was reduced from 1.8 to 1.3 days (median 1.1 vs. 0.9 days; P < .001). Adoption of peri-procedure best practices led to increased use of local anaesthesia (96.1% vs. 84.3%; P < .001) and decreased procedure (median 47 vs. 60â min; P < .001) and intervention times (85 vs. 95â min; P < .001). Thirty-day patient safety did not appear to be compromised with no differences in all-cause mortality (0.6% in both groups combined), stroke/transient ischaemic attack (1.4%), life-threatening bleeding (1.3%), stage 2/3 acute kidney injury (0.7%), and valve-related readmission (1.2%). CONCLUSIONS: Broad implementation of BENCHMARK practices contributes to improving efficiency of TAVI pathway reducing LoS and costs without compromising patient safety.
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Estenosis de la Válvula Aórtica , Benchmarking , Tiempo de Internación , Reemplazo de la Válvula Aórtica Transcatéter , Humanos , Reemplazo de la Válvula Aórtica Transcatéter/métodos , Estenosis de la Válvula Aórtica/cirugía , Masculino , Femenino , Anciano de 80 o más Años , Tiempo de Internación/estadística & datos numéricos , Anciano , Vías Clínicas , Europa (Continente)/epidemiología , Complicaciones Posoperatorias/epidemiología , Complicaciones Posoperatorias/prevención & control , Seguridad del PacienteRESUMEN
Background: Personalized prognosis plays a vital role in deciding between percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) in patients with three-vessel disease (3VD). The aim of this study is to compare the modality of revascularization chosen by the local heart team to that recommended by using individualized predictions of medium, and long-term all-cause mortality amongst patients with 3VD screened in the Multivessel TALENT trial. Methods: The SYNTAX score II (SS-II) and SS-2020 were evaluated in 200 consecutive patients by a core laboratory and compared to the decision of the "on site" heart team. Results: According to the SS-II, CABG was the recommended treatment in 51 patients (25.5%) however 34 (66.6%) of them received PCI. According to SS-2020 the predicted absolute risk differences (ARD) between PCI and CABG were significantly higher in patients receiving CABG compared to those treated by PCI for major adverse cardiovascular and cerebrovascular events, a composite of all-cause mortality, stroke or myocardial infarction at 5-years (8.8 ± 4.6% vs 6.0 ± 4.0%, p < 0.001) and all-cause mortality at 5- (5.2 ± 3.5% vs 3.7 ± 3.0%, p = 0.008) and 10-years (9.3 ± 4.8% vs 6.2 ± 4.2%, p < 0.001). Based on the novel threshold of equipoise (individual absolute risk differences [ARD] < 4.5%), 133 patients were eligible for PCI however 23 of them underwent CABG; conversely, amongst the 67 patients where CABG was recommendation (individual ARD > 4.5%), only 19 received it. Conclusions: Despite the robustness of the risk models proposed for screening, several deviations from the recommended mode of revascularization were observed by the core laboratory among the first 200 patients with 3VD screened in the Multivessel TALENT trial. Clinical Trial Registration: ClinicalTrials.gov reference: NCT04390672.
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High-risk pulmonary embolism (PE) refers to a large embolic burden causing right ventricular failure and hemodynamic instability. It accounts for approximately 5% of all cases of PE but contributes significantly to overall PE mortality. Systemic thrombolysis is the first-line revascularization therapy in high-risk PE. Surgical embolectomy or catheter-directed therapy is recommended in patients with an absolute contraindication to systemic thrombolysis. Extracorporeal membrane oxygenation (ECMO) provides respiratory and hemodynamic support for the most critically ill PE patients with refractory cardiogenic shock or cardiac arrest. The complex management of these individuals requires urgent yet coordinated multidisciplinary care. In light of existing evidence regarding the utility of ECMO in the management of high-risk PE patients, a number of possible indications for ECMO utilization have been suggested in the literature. Specifically, in patients with refractory cardiac arrest, resuscitated cardiac arrest, or refractory shock, including in cases of failed thrombolysis, venoarterial ECMO (VA-ECMO) should be considered, either as a bridge to percutaneous or surgical embolectomy or as a bridge to recovery after surgical embolectomy. We review here the current evidence on the use of ECMO as part of the management strategy for the highest-risk presentations of PE and summarize the latest data in this indication.
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Oxigenación por Membrana Extracorpórea , Embolia Pulmonar , Oxigenación por Membrana Extracorpórea/métodos , Embolia Pulmonar/terapia , Humanos , Embolectomía/métodos , Choque Cardiogénico/terapia , Resultado del Tratamiento , Terapia Trombolítica/métodosRESUMEN
INTRODUCTION: The PE-SARD score (syncope, anemia, renal dysfunction) was developed to predict the risk of major bleeding in the acute phase of pulmonary embolism (PE). METHODS: We analyzed data from 50,686 patients with acute PE included in the RIETE registry to externally validate the PE-SARD score. We calculated the overall reliability of the PE-SARD score, as well as discrimination and calibration for predicting the risk of major bleeding at 30 days. The performance of PE-SARD was compared to the BACS and PE-CH models. RESULTS: During the first 30 days, 640 patients (1.3 %) had a major bleeding event. The incidence of major bleeding within 30 days was 0.6 % in the PE-SARD-defined low-risk group, 1.5 % in the intermediate-risk group, and 2.5 % in the high-risk group, for an OR of 2.22 (95 % CI, 2.02-2.43) for the intermediate-risk group (vs low-risk group), and 3.94 for the high-risk group (vs low-risk group). The corresponding sensitivity was 81.1 % (intermediate/high vs low risk), and specificity was 85.9 % (95 % CI, 85.8-86.1) (low/intermediate vs high risk). The applicability of PE-SARD was consistent across clinically relevant patient subgroups and over shorter time periods of follow-up (i.e., 3 and 7 days). The C-index was 0.654 and calibration was excellent. The PE-SARD bleeding score improved the major bleeding risk prediction compared with the BACS and PE-CH scores. CONCLUSIONS: The PE-SARD score identifies PE patients with a higher risk of bleeding, which could assist providers for potentially adjusting PE management, in a framework of shared decision-making with individual patients.
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Embolia Pulmonar , Humanos , Reproducibilidad de los Resultados , Embolia Pulmonar/complicaciones , Embolia Pulmonar/diagnóstico , Embolia Pulmonar/epidemiología , Factores de Riesgo , Hemorragia/diagnóstico , Hemorragia/etiología , Sistema de RegistrosRESUMEN
BACKGROUND: Prior clinical trials have demonstrated the efficacy of ultrasound-facilitated catheter-directed thrombolysis (USCDT) for the treatment of acute intermediate-risk pulmonary embolism (PE) using reduced thrombolytic doses and shorter infusion durations. However, utilization and safety of such strategies in broader PE populations remain unclear. The KNOCOUT PE (The EKoSoNic Registry of the Treatment and Clinical Outcomes of Patients With Pulmonary Embolism) registry is a multicenter international registry designed to study the treatment of acute PE with USCDT, with focus on safety outcomes. METHODS: The KNOCOUT PE prospective cohort included 489 patients (64 sites internationally) with acute intermediate-high or high-risk PE treated with USCDT between March 2018 and June 2020. Principal safety outcomes were independently adjudicated International Society on Thrombosis and Haemostasis major bleeding at 72 hours post-treatment and mortality within 12 months of treatment. Additional outcomes included change in right ventricular/left ventricular ratio and quality of life measures over 12 months. RESULTS: Mean alteplase (r-tPA [recombinant tissue-type plasminogen activator]) infusion duration was 10.5 hours. Mean total r-tPA dose was 18.1 mg, with 31.0% of patients receiving ≤12 mg. Major bleeding events within 72 hours occurred in 1.6% (8/489) of patients. One patient experienced worsening of a preexisting subdural hematoma after USCDT and therapeutic anticoagulation, which ultimately required surgery. All-cause mortality at 30 days was 1.0% (5/489). Improvement in PE quality of life score was observed with a 41.1% (243/489, 49.7%) and 44.2% (153/489, 31.3%) mean relative reduction by 3 and 12 months, respectively. CONCLUSIONS: In a prospective observational cohort study of patients with intermediate-high and high-risk PE undergoing USCDT, mean r-tPA dose was 18 mg, and the rates of major bleeding and mortality were low. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03426124.
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Embolia Pulmonar , Calidad de Vida , Humanos , Catéteres , Fibrinolíticos , Hemorragia/inducido químicamente , Estudios Prospectivos , Embolia Pulmonar/diagnóstico por imagen , Embolia Pulmonar/tratamiento farmacológico , Sistema de Registros , Factores de Riesgo , Terapia Trombolítica/efectos adversos , Resultado del TratamientoRESUMEN
Introducción y objetivos. El papel las lipoproteínas de alta densidad en la estratificación de riesgo en pacientes con dolor torácico no está bien definido. El objetivo de este estudio es conocer la contribución relativa del perfil lipídico al riesgo de padecer síndrome coronario agudo de los pacientes ingresados por dolor torácico en una planta de cardiología. Métodos. Incluimos todos los ingresos consecutivos no programados en planta de cardiología durante 15 meses y realizamos seguimiento al año. Resultados. Se incluyó a 959 pacientes, 457 (47,7%) diagnosticados de dolor torácico no isquémico, 355 (37%) de síndrome coronario agudo sin elevación del ST y 147 (15,3%) de síndrome coronario agudo con elevación del ST. El 54,6% de los pacientes presentaron cifras de lipoproteínas de alta densidad < 40mg/dl y la prevalencia fue más elevada entre los pacientes con síndrome coronario agudo (el 69,4 frente al 30,6%; p<0,01). Se observó mayor presencia de síndrome coronario agudo a menores cifras medias de lipoproteínas de alta densidad. Edad, tabaquismo activo, diabetes mellitus, glucemia basal > 100mg/dl y concentraciones de lipoproteínas de alta densidad < 40mg/dl se asociaron independientemente a la presencia de síndrome coronario agudo, el factor con mayor asociación (odds ratio=4,11; intervalo de confianza del 95%, 2,87-5,96). El análisis de supervivencia determinó que los pacientes con síndrome coronario agudo, frente a dolor torácico no isquémico, asociaron un riesgo significativamente superior de mortalidad por cualquier causa, así como por causa cardiovascular. Conclusiones. Las concentraciones bajas de colesterol unido a las lipoproteínas de alta densidad (≤ 40mg/dl) se asociaron de manera independiente a diagnóstico de síndrome coronario agudo en pacientes ingresados por dolor torácico, con una relación inversa significativa entre los valores más bajos de lipoproteínas de alta densidad y el diagnóstico de síndrome coronario agudo (AU)
Introduction and objectives. To compare acute myocardial infarction patients with or without congestive heart failure in the French FAST-MI registry. Methods. The French FAST-MI registry included 374 centers and 3059 patients over a 1-month period at the end of 2005, with 1-year follow-up. Among this population, patients with at least one congestive heart failure criterion constituted group 1 (n=1149; 37.5%) and were compared to patients without congestive heart failure (group 2, n=1910; 62.5%). The congestive heart failure patients were further divided according to presence of both beta-blockers and antagonists of the renin-angiotensin-aldosterone system at hospital discharge (n=511) or not (n=498), in order to assess the real-world clinical importance of recommended medications. Results. Overall in-hospital and 1-year mortality rates were 3.4% and 13.2%, respectively. In hospital survivors, presence of congestive heart failure was associated with increased mortality (adjusted hazard ratio=1.55; 95% confidence interval, 1.10-2.17; P=.01). Survival was higher in patients without congestive heart failure, compared with congestive heart failure patients receiving or not recommended medications (P<.001). Congestive heart failure patients receiving neither renin-angiotensin-aldosterone system blockers nor beta-blockers (adjusted hazard ratio=1.66; 95% confidence interval, 1.08-2.55; P=.02) had a significantly higher risk of death than patients receiving both classes of medications (adjusted hazard ratio=1.16; 95% confidence interval, 0.82-1.64; not statistically significant). Patients receiving only one of the recommended classes had an intermediate risk (adjusted hazard ratio=1.47; 95% confidence interval, 1.04-2.07; P=.03). Conclusions. Patients admitted for acute myocardial infarction with congestive heart failure criteria are still at very high risk of mortality. When receiving major recommended medications, they presented with significantly reduced mortality rates. Additional efforts should therefore be made to encourage the prescription of recommended medications in acute myocardial infarction patients with congestive heart failure (AU)