RESUMEN
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.
Asunto(s)
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
OBJECTIVES: This study sought to assess the efficacy of the drug-coated balloon (DCB) ESSENTIAL for the treatment of in-stent restenosis (ISR). BACKGROUND: DCBs have proven a valid therapeutic option for the management of ISR in several clinical trials, yet no class effect can be claimed. Accordingly, every new DCB model has to be individually evaluated through clinical studies. METHODS: This is a prospective, multicenter study including consecutive patients undergoing percutaneous coronary intervention for ISR with the ESSENTIAL DCB. A 6-month quantitative coronary angiography (QCA)/optical coherence tomography (OCT) follow-up was scheduled. The primary endpoint was OCT-derived in-segment maximal area stenosis. Secondary endpoints included QCA-derived in-segment late lumen loss (LLL) and target lesion failure (TLF) rates at 6, 12, and 24â¯months. TLF was defined as the composite of cardiac death, target vessel myocardial infarction, and target lesion revascularization. RESULTS: A total of 31 patients were successfully treated with DCB, with 67% of ISR corresponding to drug-eluting stents (DES). At 6â¯months, 26 patients underwent the scheduled angiographic follow-up. The mean value for in-segment maximal area stenosis was 51.4⯱â¯13% and the median value was 53% (IQR 46.4-59.5). In the DES-ISR subgroup, these parameters were 52.6⯱â¯10% and 55.2% (IQR 49.3-58.5), respectively. In-segment LLL was 0.25⯱â¯0.43â¯mm with only 2 (7.7%) patients showing binary restenosis (>50%). The incidence of TLF was 10% at 6â¯months, 13.3% at 12â¯months, and 13.3% at 24â¯months. CONCLUSIONS: In this study, the ESSENTIAL DCB showed sustained efficacy in the prevention of recurrent restenosis after treatment of ISR. SUMMARY: We sought to assess the efficacy of the drug-coated balloon ESSENTIAL for the treatment of in-stent restenosis through a prospective, multicenter study including QCA and OCT assessment at 6-month follow-up. The primary endpoint was in-segment maximal area stenosis. Among the 31 patients successfully treated with the ESSENTIAL DCB, an angiographic follow-up was conducted in 26. Mean in-segment maximal area stenosis was 51.4⯱â¯13% and the median value was 53% (IQR 46.4-59.5). In the DES-ISR subgroup, corresponding values were 52.6⯱â¯10% and 55.2% (IQR 49.3-58.5), respectively. The observed in-segment LLL was 0.25⯱â¯0.43â¯mm and binary restenosis rate was 7.7%. TLF was 10% at 6â¯months and 13.3% at 12 and 24â¯months.
Asunto(s)
Angioplastia Coronaria con Balón/instrumentación , Fármacos Cardiovasculares/administración & dosificación , Materiales Biocompatibles Revestidos , Angiografía Coronaria , Enfermedad de la Arteria Coronaria/terapia , Reestenosis Coronaria/terapia , Vasos Coronarios/diagnóstico por imagen , Paclitaxel/administración & dosificación , Intervención Coronaria Percutánea/instrumentación , Stents , Tomografía de Coherencia Óptica , Anciano , Angioplastia Coronaria con Balón/efectos adversos , Angioplastia Coronaria con Balón/mortalidad , Fármacos Cardiovasculares/efectos adversos , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Enfermedad de la Arteria Coronaria/mortalidad , Reestenosis Coronaria/diagnóstico por imagen , Reestenosis Coronaria/etiología , Reestenosis Coronaria/mortalidad , Diseño de Equipo , Femenino , Humanos , Masculino , Persona de Mediana Edad , Paclitaxel/efectos adversos , Intervención Coronaria Percutánea/efectos adversos , Intervención Coronaria Percutánea/mortalidad , Valor Predictivo de las Pruebas , Estudios Prospectivos , Factores de Riesgo , España , Resultado del TratamientoRESUMEN
INTRODUCTION AND OBJECTIVES: To analyze the percutaneous revascularization strategy for severe lesions in the secondary branches (SB) (diameter ≥ 2mm) of major epicardial arteries compared with conservative treatment. METHODS: This study analyzed patients with severe SB lesions who underwent percutaneous revascularization treatment compared with patients who received pharmacological treatment. The study examined the percentage of branch-related events (cardiovascular death, myocardial infarction attributable to SB, or the need for revascularization of the SB). RESULTS: We analyzed 679 SB lesions (662 patients). After a mean follow-up of 22.2±10.5 months, there were no significant differences between the 2 treatment groups regarding the percentage of death from cardiovascular causes (1.7% vs 0.4%; P=.14), nonfatal acute myocardial infarction (AMI) (1.7% vs 1.7%; P=.96), the need for SB revascularization (4.1% vs 5.4%; P=.45) or in the total percentage of events (5.1% vs 6.3%; P=.54). The variables showing an association with event occurrence on multivariate analysis were diabetes (SHR, 2.87; 95%CI, 1.37-5.47; P=.004), prior AMI (SHR, 3.54; 95%CI, 1.77-7.30; P<.0001), SB reference diameter (SHR, 0.16; 95%CI, 0.03-0.97; P=.047), and lesion length (SHR, 3.77; 95%CI, 1.03-1.13; P<.0001). These results remained the same after the propensity score analysis. CONCLUSIONS: The percentage of SB-related events during follow-up is low, with no significant differences between the 2 treatment strategies. The variables associated with event occurrence in the multivariate analysis were the presence of diabetes mellitus, prior AMI, and greater lesion length.
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Estenosis Coronaria/cirugía , Vasos Coronarios/cirugía , Intervención Coronaria Percutánea/métodos , Anciano , Angiografía Coronaria , Estenosis Coronaria/diagnóstico , Vasos Coronarios/diagnóstico por imagen , Femenino , Estudios de Seguimiento , Humanos , Masculino , Persona de Mediana Edad , Puntaje de Propensión , Estudios Retrospectivos , Índice de Severidad de la Enfermedad , Resultado del TratamientoRESUMEN
No disponible
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Humanos , Intervención Coronaria Percutánea , Vasos Coronarios/diagnóstico por imagen , Vasos Coronarios/cirugía , Composición Familiar , Prevalencia , RegistrosRESUMEN
Introducción y objetivos: Comparar la estrategia de revascularización percutánea de lesiones graves en ramas coronarias secundarias (RS) (diámetro ≥ 2 mm) de arterias epicárdicas mayores frente al tratamiento conservador. Métodos: Estudio de cohortes retrospectivo en el que se compara a pacientes con lesiones graves en RS de arterias epicárdicas principales tratados con revascularización percutánea o con un tratamiento farmacológico a criterio del operador. Se analizó el porcentaje de eventos relacionados con la rama (muerte cardiovascular, infarto de miocardio atribuible a RS o necesidad de revascularización de la RS). Resultados: Se analizaron 679 lesiones en RS (662 pacientes). Tras un seguimiento medio de 22,2+/-10,5 meses, no hubo diferencias significativas entre ambos grupos de tratamiento en mortalidad de causa cardiovascular (el 1,7 frente al 0,4%; p=0,14), infarto agudo de miocardio (IAM) no fatal (el 1,7 frente al 1,7%; p=0,96) o necesidad de revascularización de la RS (el 4,1 frente al 5,4%; p=0,45) ni en el porcentaje total de eventos (el 5,1 frente al 6,3%; p=0,54). Las variables que mostraron asociación con la ocurrencia de eventos en el análisis multivariable fueron la diabetes (sHR=2,87; IC95%, 1,37-5,47; p=0,004), IAM previo (sHR=3,54; IC95%, 1,77-7,30; p < 0,0001), el diámetro de referencia de la RS (sHR=0,16; IC95%, 0,03-0,97; p=0,047) y la longitud de la lesión (sHR=3,77; IC95%, 1,03-1,13; p < 0,0001). Estos resultados se mantuvieron tras realizar análisis por puntuación de propensión. Conclusiones: En el seguimiento, el porcentaje de eventos relacionados con la RS fue bajo respecto al total de pacientes, sin diferencias significativas entre una y otra estrategia de tratamiento. Las variables que se asociaron con la ocurrencia de eventos en el análisis multivariable fueron la diabetes mellitus, el antecedente de IAM y la mayor longitud de la lesión
Introduction and objectives: To analyze the percutaneous revascularization strategy for severe lesions in the secondary branches (SB) (diameter ≥ 2mm) of major epicardial arteries compared with conservative treatment. Methods: This study analyzed patients with severe SB lesions who underwent percutaneous revascularization treatment compared with patients who received pharmacological treatment. The study examined the percentage of branch-related events (cardiovascular death, myocardial infarction attributable to SB, or the need for revascularization of the SB). Results: We analyzed 679 SB lesions (662 patients). After a mean follow-up of 22.2+/-10.5 months, there were no significant differences between the 2 treatment groups regarding the percentage of death from cardiovascular causes (1.7% vs 0.4%; P=.14), nonfatal acute myocardial infarction (AMI) (1.7% vs 1.7%; P=.96), the need for SB revascularization (4.1% vs 5.4%; P=.45) or in the total percentage of events (5.1% vs 6.3%; P=.54). The variables showing an association with event occurrence on multivariate analysis were diabetes (SHR, 2.87; 95%CI, 1.37-5.47; P=.004), prior AMI (SHR, 3.54; 95%CI, 1.77-7.30; P<.0001), SB reference diameter (SHR, 0.16; 95%CI, 0.03-0.97; P=.047), and lesion length (SHR, 3.77; 95%CI, 1.03-1.13; P<.0001). These results remained the same after the propensity score analysis. Conclusions: The percentage of SB-related events during follow-up is low, with no significant differences between the 2 treatment strategies. The variables associated with event occurrence in the multivariate analysis were the presence of diabetes mellitus, prior AMI, and greater lesion length
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Humanos , Intervención Coronaria Percutánea/métodos , Oclusión Coronaria/cirugía , Síndrome Coronario Agudo/cirugía , Angiografía Coronaria/métodos , Vasos Coronarios/diagnóstico por imagen , Estudios Retrospectivos , Angina Estable/fisiopatologíaAsunto(s)
Angina Inestable/terapia , Fármacos Cardiovasculares/administración & dosificación , Aneurisma Coronario/etiología , Trombosis Coronaria/etiología , Stents Liberadores de Fármacos , Intervención Coronaria Percutánea/efectos adversos , Intervención Coronaria Percutánea/instrumentación , Sirolimus/administración & dosificación , Adulto , Angina Inestable/diagnóstico por imagen , Aneurisma Coronario/diagnóstico por imagen , Angiografía Coronaria , Trombosis Coronaria/diagnóstico por imagen , Humanos , Masculino , Diseño de Prótesis , Factores de Tiempo , Tomografía de Coherencia Óptica , Resultado del TratamientoRESUMEN
No disponible
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Humanos , Masculino , Femenino , Persona de Mediana Edad , Comorbilidad , Insuficiencia Cardíaca/complicaciones , Insuficiencia Cardíaca/mortalidad , Mortalidad Hospitalaria/tendencias , Servicio de Cardiología en Hospital/organización & administración , Servicio de Cardiología en Hospital/normas , Servicio de Cardiología en Hospital , Fibrilación Ventricular/complicaciones , Fibrilación Ventricular/epidemiología , Modelos Logísticos , Fibrilación Ventricular/mortalidad , Oportunidad Relativa , Intervalos de ConfianzaRESUMEN
No disponible
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