RESUMEN
Much management and leadership development provision for healthcare professionals has been the subject of considerable criticism, and there have been numerous calls for training programmes explicitly focused on the specific managerial (manager/leader) behaviours healthcare managers, physician leaders and nurse managers need to exhibit to be perceived effective. The aim of our multiple cross-case/cross-nation comparative study has been to: i) identify similarities and differences between the findings of published qualitative critical incident studies of effective and ineffective managerial behaviour observed within British, Egyptian, Mexican and Romanian public hospitals, respectively, and ii) if possible, deduce from the identified commonalities a healthcare-related behavioural model of perceived managerial and leadership effectiveness. Adopting a philosophical stance informed by pragmatism, epistemological instrumentalism and abduction, we used realist qualitative analytic methods to code and classify into a maximum number of discrete behavioural categories empirical source data obtained from five previous studies. We found high degrees of empirical generalization which resulted in the identification of five positive (effective) and four negative (ineffective) behavioural dimensions (BDs) derived, respectively, from 14 positive and 9 negative deduced behavioural categories (BCs). These BDs and underpinning BCs are expressed in the form of an emergent two-factor universalistic behavioural model of perceived managerial and leadership effectiveness. We suggest the model could be used to critically evaluate the relevance and appropriateness of existing training provision for physician leaders, nurse managers and other healthcare managers/leaders in public hospitals or to design new explicit training programmes informed and shaped by healthcare-specific management research, as called for in the literature.
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Personal de Salud , Liderazgo , Humanos , Investigación Cualitativa , Atención a la Salud , Servicios de SaludRESUMEN
Ongoing inputs, in the form of sediment deposition along with associated dissolved contaminants, have challenged the assessment of cap performance at contaminated sediment sites. To address this issue, thin 2-3 cm layer sand caps amended with activated carbon (AC) were investigated for the remediation of polychlorinated biphenyl (PCB) contaminated marine sediments using 90-day mesocosms. All treatments were challenged with (1) ongoing clean or marker-PCB-spiked sediment inputs and (2) bioturbation. Bioaccumulation in hard clams (filter feeding near the cap-water interface) was evaluated to best understand cap effectiveness, relative to sheepshead minnows (confined to the surface water) and sandworms (which burrowed through the caps). All caps (sand and AC amended sand) provided isolation of native bedded PCBs (i.e., PCBs sourced from the bed), reducing uptake in organisms. Total PCB bioaccumulation in clams indicated that AC addition to the cap provided no benefit with spiked influx, or some benefit (56% reduction) with clean influx. Spiked input PCBs, when added to the depositional input sediment, were consistently detected in clams and passive samplers, with and without AC in the cap. PCB uptake by passive samplers located in the caps did not reflect the performance of the remedy, as defined by clam bioaccumulation. However, PCB uptake by passive samplers in the overlying water reasonably represented clam bioaccumulation results.
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Mercenaria , Bifenilos Policlorados , Contaminantes Químicos del Agua , Animales , Carbón Orgánico , Sedimentos Geológicos , Bifenilos Policlorados/análisis , Arena , Contaminantes Químicos del Agua/análisisRESUMEN
BACKGROUND: Randomised trial data assessing the safety and efficacy of the self-expanding intra-annular Portico transcatheter aortic valve system (Abbott Structural Heart, St Paul, MN, USA) compared with any commercially available valves are needed to compare performance among designs. METHODS: In this prospective, multicentre, non-inferiority, randomised controlled trial (the Portico Re-sheathable Transcatheter Aortic Valve System US Investigational Device Exemption trial [PORTICO IDE]), high and extreme risk patients with severe symptomatic aortic stenosis were recruited from 52 medical centres experienced in performing transcatheter aortic valve replacement in the USA and Australia. Patients were eligible if they were aged 21 years or older, in New York Heart Association functional class II or higher, and had severe native aortic stenosis. Eligible patients were randomly assigned (1:1) using permuted block randomisation (block sizes of 2 and 4) and stratified by clinical investigational site, surgical risk cohort, and vascular access method, to transcatheter aortic valve replacement with the first generation Portico valve and delivery system or a commercially available valve (either an intra-annular balloon-expandable Edwards-SAPIEN, SAPIEN XT, or SAPIEN 3 valve [Edwards LifeSciences, Irvine, CA, USA]; or a supra-annular self-expanding CoreValve, Evolut-R, or Evolut-PRO valve [Medtronic, Minneapolis, MN, USA]). Investigational site staff, implanting physician, and study participant were unmasked to treatment assignment. Core laboratories and clinical event assessors were masked to treatment allocation. The primary safety endpoint was a composite of all-cause mortality, disabling stroke, life-threatening bleeding requiring transfusion, acute kidney injury requiring dialysis, or major vascular complication at 30 days. The primary efficacy endpoint was all-cause mortality or disabling stroke at 1 year. Clinical outcomes and valve performance were assessed up to 2 years after the procedure. Primary analyses were by intention to treat and the Kaplan-Meier method to estimate event rates. The non-inferiority margin was 8·5% for primary safety and 8·0% for primary efficacy endpoints. This study is registered with ClinicalTrials.gov, NCT02000115, and is ongoing. FINDINGS: Between May 30 and Sept 12, 2014, and between Aug 21, 2015, and Oct 10, 2017, with recruitment paused for 11 months by the funder, we recruited 1034 patients, of whom 750 were eligible and randomly assigned to the Portico valve group (n=381) or commercially available valve group (n=369). Mean age was 83 years (SD 7) and 395 (52·7%) patients were female. For the primary safety endpoint at 30 days, the event rate was higher in the Portico valve group than in the commercial valve group (52 [13·8%] vs 35 [9·6%]; absolute difference 4·2, 95% CI -0·4 to 8·8 [upper confidence bound {UCB} 8·1%]; pnon-inferiority=0·034, psuperiority=0·071). At 1 year, the rates of the primary efficacy endpoint were similar between the groups (55 [14·8%] in the Portico group vs 48 [13·4%] in the commercial valve group; difference 1·5%, 95% CI -3·6 to 6·5 [UCB 5·7%]; pnon-inferiority=0·0058, psuperiority=0·50). At 2 years, rates of death (80 [22·3%] vs 70 [20·2%]; p=0·40) or disabling stroke (10 [3·1%] vs 16 [5·0%]; p=0·23) were similar between groups. INTERPRETATION: The Portico valve was associated with similar rates of death or disabling stroke at 2 years compared with commercial valves, but was associated with higher rates of the primary composite safety endpoint including death at 30 days. The first-generation Portico valve and delivery system did not offer advantages over other commercially available valves. FUNDING: Abbott.
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Estenosis de la Válvula Aórtica/cirugía , Prótesis Valvulares Cardíacas , Mortalidad , Complicaciones Posoperatorias/epidemiología , Diseño de Prótesis , Accidente Cerebrovascular/epidemiología , Reemplazo de la Válvula Aórtica Transcatéter , Lesión Renal Aguda/epidemiología , Lesión Renal Aguda/terapia , Anciano , Anciano de 80 o más Años , Australia , Transfusión Sanguínea , Causas de Muerte , Femenino , Humanos , Masculino , Complicaciones Posoperatorias/terapia , Hemorragia Posoperatoria/epidemiología , Hemorragia Posoperatoria/terapia , Diálisis Renal , Índice de Severidad de la Enfermedad , Resultado del Tratamiento , Estados UnidosRESUMEN
A virtual aortic annular plane that is built using the three hinge points, known as the hinge point-based annular plane (HPAP), is routinely used during transcatheter aortic valve replacement (TAVR). Abnormal aortic cusps (AAC) with unequal length and size influence the relationship of the HPAP to the aortic root axis significantly and pose challenges to valve deployment, leading to paravalvular leak and valve embolisation. Obtaining a centreline-based aortic annular plane in addition may help to understand valve deployment behaviour in AAC better.
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Insuficiencia de la Válvula Aórtica/cirugía , Estenosis de la Válvula Aórtica/cirugía , Prótesis Valvulares Cardíacas , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Válvula Aórtica/cirugía , Humanos , Diseño de Prótesis , Resultado del TratamientoRESUMEN
BACKGROUND: The Harmonization By Doing (HBD) program was established in 2003 as a partnership among stakeholders of academia, industry and regulatory agencies in Japan and the United States, with a primary focus on streamlining processes of global medical device development for cardiovascular medical devices. While HBD has traditionally focused on development of devices intended to treat conditions prevalent in adults, in 2016, HBD established the "HBD-for-Children" program, which focuses on the development of pediatric devices as the development of medical devices for pediatric use lags behind that of medical devices for adults in both countries.MethodsâandâResults:Activities of the program have included: (1) conducting a survey with industry to better understand the challenges that constrain the development of pediatric medical devices; (2) categorizing pediatric medical devices into five categories based on global availability and exploring concrete solutions for the early application and regulatory approval in both geographies; and (3) facilitating global clinical trials of pediatric medical devices in both countries. CONCLUSIONS: The establishment of the HBD-for-Children program is significant because it represents a global initiative for the introduction of pediatric medical devices for patients in a timely manner. Through the program, academia, industry and regulatory agencies can work together to facilitate innovative pediatric device development from a multi-stakeholder perspective. This activity could also encourage industry partners to pursue the development of pediatric medical devices.
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Cateterismo Cardíaco/instrumentación , Procedimientos Quirúrgicos Cardíacos/instrumentación , Enfermedades Cardiovasculares/terapia , Conducta Cooperativa , Diseño de Equipo , Equipos y Suministros , Cooperación Internacional , Pediatría/instrumentación , Asociación entre el Sector Público-Privado , Enfermedades Cardiovasculares/diagnóstico , Enfermedades Cardiovasculares/fisiopatología , Humanos , Japón , Evaluación de Programas y Proyectos de Salud , Participación de los Interesados , Estados UnidosRESUMEN
Transcatheter therapies to treat tricuspid regurgitation are being developed, but few have attempted the gold standard of surgical repair: ring annuloplasty. We describe the first-ever fully percutaneous implantation of a circumferential, semirigid annuloplasty ring to treat massive secondary tricuspid regurgitation. (Level of Difficulty: Advanced.).
RESUMEN
Acute circulatory collapse may rarely occur during transcatheter aortic valve implantation (TAVI). In such cases, immediate mechanical circulatory support (MCS) as a bridge to remedial interventions may be required. To define the rate of MCS utilization in TAVI patients and identify the predictors of MCS utilization in a cohort of TAVI patients. TAVI patients between January 2012 and September 2015 were identified in the National Inpatient Sample (NIS) by using the International Classification of Diseases, 9th Revision. Trend weights were used to generate the national estimates of MCS rate in TAVI. Multivariate regression analysis was done to identify predictors of MCS use. A total 60,985 patients underwent TAVI with 1,695 patients receiving MCS (2.8%) during index hospitalization. The most common type of MCS was intra-aortic balloon pump in 52%, followed by extra corporeal membrane oxygenator in 34%, then percutaneous ventricular assist device in 7.4%. Rate of MCS use declined over the study period from 3% in 2012 (Q1) to 1.8% in 2015 (Q3). The use of MCS during TAVI was associated with 10-fold increase in-hospital mortality (27.1% vs 2.8%, p <0.001). Predictors of MCS were congestive heart failure (ORâ¯=â¯2.58, p <0.001), transapical access (ORâ¯=â¯1.92, p <0.001), respiratory complication (ORâ¯=â¯5.19, p <0.001), acute myocardial infarction (ORâ¯=â¯4.21, p <0.001), cardiac arrest (ORâ¯=â¯10.65, p <0.001), and cardiogenic shock (ORâ¯=â¯19.09, p <0.001). In conclusion, the rate of MCS during TAVI hospitalization in the United States declined between 2012 and 2015. MCS during TAVI was associated with a 10-fold increase in in-hospital mortality.
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Estenosis de la Válvula Aórtica/cirugía , Oxigenación por Membrana Extracorpórea/estadística & datos numéricos , Corazón Auxiliar/estadística & datos numéricos , Contrapulsador Intraaórtico/estadística & datos numéricos , Choque Cardiogénico/terapia , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Reemplazo de la Válvula Aórtica Transcatéter/métodos , Anciano , Anciano de 80 o más Años , Femenino , Mortalidad Hospitalaria/tendencias , Humanos , Incidencia , Pacientes Internos/estadística & datos numéricos , Masculino , Puntaje de Propensión , Estudios Retrospectivos , Factores de Riesgo , Choque Cardiogénico/epidemiología , Choque Cardiogénico/etiología , Tasa de Supervivencia/tendencias , Estados Unidos/epidemiologíaRESUMEN
Activated carbon-amended bed sediments reduced total polychlorinated biphenyl (PCB) accumulation in 3 functionally different marine species, sandworms (Alitta virens), hard clams (Mercenaria mercenaria), and sheepshead minnows (Cyprinodon variegatus), during both clean and contaminated ongoing sediment inputs. Mesocosm experiments were conducted for 90 d to evaluate native, field-aged bed sediment PCBs, and ongoing input PCBs added 3 times a week. Simulated in situ remediation applied an activated carbon dose equal to the native organic carbon content that was premixed into the bed sediment for 1 mo. The highest bioaccumulation of native PCBs was in worms that remained in and directly ingested the sediment, whereas the highest bioaccumulation of the input PCBs was in fish that were exposed to the water column. When periodic PCB-contaminated sediment inputs were introduced to the water column, the activated carbon remedy had minimal effect on the input PCBs, whereas the native bed PCBs still dominated bioaccumulation in the control (no activated carbon). Therefore, remediation of only the local bedded sediment in environmental systems with ongoing contaminant inputs may have lower efficacy for fish and other pelagic and epibenthic organisms. While ongoing inputs continue to obscure remedial outcomes at contaminated sediment sites, the present study showed clear effectiveness of activated carbon amendment remediation on native PCBs despite these inputs but no remediation effectiveness for the input-associated PCBs (at least within the present study duration). Environ Toxicol Chem 2019;38:2326-2336. Published 2019 Wiley Periodicals Inc. on behalf of SETAC. This article is a US government work and, as such, is in the public domain in the United States of America.
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Carbón Orgánico/química , Monitoreo del Ambiente , Sedimentos Geológicos/química , Bifenilos Policlorados/análisis , Animales , Bioacumulación , Biodegradación Ambiental , Biodiversidad , Bivalvos/metabolismo , Peces/metabolismo , Lípidos/análisis , Poliquetos/metabolismo , Especificidad de la EspecieAsunto(s)
Procedimientos Quirúrgicos Cardíacos , Síndrome de Down/complicaciones , Defectos del Tabique Interventricular/cirugía , Insuficiencia de la Válvula Mitral/etiología , Válvula Mitral/anomalías , Síndrome de Down/diagnóstico , Ecocardiografía Doppler en Color , Ecocardiografía Tridimensional , Ecocardiografía Transesofágica , Femenino , Defectos del Tabique Interventricular/complicaciones , Defectos del Tabique Interventricular/diagnóstico por imagen , Defectos del Tabique Interventricular/fisiopatología , Humanos , Persona de Mediana Edad , Válvula Mitral/diagnóstico por imagen , Válvula Mitral/fisiopatología , Válvula Mitral/cirugía , Insuficiencia de la Válvula Mitral/diagnóstico por imagen , Insuficiencia de la Válvula Mitral/fisiopatología , Insuficiencia de la Válvula Mitral/cirugía , Pericardio/trasplante , Recuperación de la Función , Técnicas de Sutura , Tomografía Computarizada por Rayos X , Resultado del TratamientoRESUMEN
BACKGROUND: During the introduction of transcatheter aortic-valve replacement (TAVR) in the United States, requirements regarding procedural volume were mandated by the Centers for Medicare and Medicaid Services as a condition of reimbursement. A better understanding of the relationship between hospital volume of TAVR procedures and patient outcomes could inform policy decisions. METHODS: We analyzed data from the Transcatheter Valve Therapy Registry regarding procedural volumes and outcomes from 2015 through 2017. The primary analyses examined the association between hospital procedural volume as a continuous variable and risk-adjusted mortality at 30 days after transfemoral TAVR. Secondary analysis included risk-adjusted mortality according to quartile of hospital procedural volume. A sensitivity analysis was performed after exclusion of the first 12 months of transfemoral TAVR procedures at each hospital. RESULTS: Of 113,662 TAVR procedures performed at 555 hospitals by 2960 operators, 96,256 (84.7%) involved a transfemoral approach. There was a significant inverse association between annualized volume of transfemoral TAVR procedures and mortality. Adjusted 30-day mortality was higher and more variable at hospitals in the lowest-volume quartile (3.19%; 95% confidence interval [CI], 2.78 to 3.67) than at hospitals in the highest-volume quartile (2.66%; 95% CI, 2.48 to 2.85) (odds ratio, 1.21; P = 0.02). The difference in adjusted mortality between a mean annualized volume of 27 procedures in the lowest-volume quartile and 143 procedures in the highest-volume quartile was a relative reduction of 19.45% (95% CI, 8.63 to 30.26). After the exclusion of the first 12 months of TAVR procedures at each hospital, 30-day mortality remained higher in the lowest-volume quartile than in the highest-volume quartile (3.10% vs. 2.61%; odds ratio, 1.19; 95% CI, 1.01 to 1.40). CONCLUSIONS: An inverse volume-mortality association was observed for transfemoral TAVR procedures from 2015 through 2017. Mortality at 30 days was higher and more variable at hospitals with a low procedural volume than at hospitals with a high procedural volume. (Funded by the American College of Cardiology Foundation National Cardiovascular Data Registry and the Society of Thoracic Surgeons.).
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Estenosis de la Válvula Aórtica/cirugía , Hospitales de Alto Volumen/estadística & datos numéricos , Hospitales de Bajo Volumen/estadística & datos numéricos , Reemplazo de la Válvula Aórtica Transcatéter/mortalidad , Anciano , Anciano de 80 o más Años , Válvula Aórtica/cirugía , Centers for Medicare and Medicaid Services, U.S. , Femenino , Mortalidad Hospitalaria , Humanos , Reembolso de Seguro de Salud/normas , Masculino , Estudios Retrospectivos , Reemplazo de la Válvula Aórtica Transcatéter/métodos , Reemplazo de la Válvula Aórtica Transcatéter/estadística & datos numéricos , Resultado del Tratamiento , Estados Unidos/epidemiologíaAsunto(s)
Estenosis de la Válvula Aórtica/cirugía , Valvuloplastia con Balón/instrumentación , Catéteres Cardíacos , Remoción de Dispositivos/métodos , Reemplazo de la Válvula Aórtica Transcatéter/instrumentación , Anciano de 80 o más Años , Estenosis de la Válvula Aórtica/diagnóstico por imagen , Estenosis de la Válvula Aórtica/fisiopatología , Valvuloplastia con Balón/efectos adversos , Falla de Equipo , Femenino , Humanos , Índice de Severidad de la Enfermedad , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Resultado del TratamientoAsunto(s)
Cateterismo Cardíaco/instrumentación , Remoción de Dispositivos , Migración de Cuerpo Extraño/terapia , Implantación de Prótesis de Válvulas Cardíacas/instrumentación , Prótesis Valvulares Cardíacas , Insuficiencia de la Válvula Mitral/cirugía , Prolapso de la Válvula Mitral/cirugía , Válvula Mitral/cirugía , Anciano de 80 o más Años , Cateterismo Cardíaco/efectos adversos , Femenino , Migración de Cuerpo Extraño/diagnóstico por imagen , Migración de Cuerpo Extraño/etiología , Implantación de Prótesis de Válvulas Cardíacas/efectos adversos , Hemodinámica , Humanos , Válvula Mitral/diagnóstico por imagen , Válvula Mitral/fisiopatología , Insuficiencia de la Válvula Mitral/diagnóstico por imagen , Insuficiencia de la Válvula Mitral/fisiopatología , Prolapso de la Válvula Mitral/diagnóstico por imagen , Prolapso de la Válvula Mitral/fisiopatología , Resultado del TratamientoRESUMEN
The VARC (Valve Academic Research Consortium) for transcatheter aortic valve replacement set the standard for selecting appropriate clinical endpoints reflecting safety and effectiveness of transcatheter devices, and defining single and composite clinical endpoints for clinical trials. No such standardization exists for circumferentially sutured surgical valve paravalvular leak (PVL) closure. This document seeks to provide core principles, appropriate clinical endpoints, and endpoint definitions to be used in clinical trials of PVL closure devices. The PVL Academic Research Consortium met to review evidence and make recommendations for assessment of disease severity, data collection, and updated endpoint definitions. A 5-class grading scheme to evaluate PVL was developed in concordance with VARC recommendations. Unresolved issues in the field are outlined. The current PVL Academic Research Consortium provides recommendations for assessment of disease severity, data collection, and endpoint definitions. Future research in the field is warranted.
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Válvula Aórtica/cirugía , Ensayos Clínicos como Asunto/métodos , Prótesis Valvulares Cardíacas/efectos adversos , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Dispositivos de Cierre Vascular/normas , Válvula Aórtica/patología , Insuficiencia de la Válvula Aórtica/complicaciones , Insuficiencia de la Válvula Aórtica/cirugía , Cateterismo Cardíaco/métodos , Cateterismo Cardíaco/normas , Ensayos Clínicos como Asunto/normas , Ecocardiografía/métodos , Determinación de Punto Final , Prótesis Valvulares Cardíacas/normas , Humanos , Evaluación de Resultado en la Atención de Salud , Proyectos de Investigación , Medición de Riesgo , Índice de Severidad de la Enfermedad , SuturasRESUMEN
BACKGROUND: Transcatheter aortic valve replacement (TAVR) is an alternative to surgical aortic valve replacement (SAVR) for patients with severe symptomatic aortic stenosis (AS) who are at intermediate and high risk for surgery. Commercial use of TAVR has expanded to patients with end stage renal disease (ESRD). OBJECTIVES: Compare in-hospital outcomes of TAVR versus SAVR in ESRD patients requiring hemodialysis (HD). METHODS: ESRD patients on HD undergoing TAVR (n = 328) or SAVR (n = 697) between 2012 and 2014 were identified in the National Inpatient Sample (NIS). Propensity-score matching method was used to minimize selection bias. Baseline characteristics and in-hospital outcomes were compared. RESULTS: TAVR patients were older (75.3 vs. 61.6 years, P < 0.001) and had more comorbidities, including congestive heart failure (16.2% vs. 7.5%), diabetes mellitus (28.4% vs. 22.5%), chronic lung disease (27.7% vs. 20.4%), and peripheral vascular disease (35.1% vs. 21.2%). Propensity-score matching yielded 175 pairs of patients matched on 30 baseline covariates. Overall in-hospital mortality was high (9.9%) and similar between TAVR and SAVR (8% vs. 10.3%, P = 0.58). TAVR was associated with shorter length of stay (LOS) (8 vs. 14 days, P < 0.001), lower hospitalization cost ($276,448 vs. $364,280, P = 0.01), lower in-hospital complications (60.6% vs. 76%, P = 0.003), and higher rate of home discharge (31.4% vs. 17.7%, P = 0.004) compared with SAVR. CONCLUSIONS: Regardless of treatment modality, patients with AS on HD have high in-hospital mortality. TAVR and SAVR have comparable in-hospital mortality in this population. However, TAVR is associated with shorter LOS, lower hospitalization costs, lower in-hospital complications, and higher rates of home discharge.
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Estenosis de la Válvula Aórtica/cirugía , Implantación de Prótesis de Válvulas Cardíacas , Fallo Renal Crónico/terapia , Diálisis Renal , Reemplazo de la Válvula Aórtica Transcatéter , Anciano , Anciano de 80 o más Años , Estenosis de la Válvula Aórtica/diagnóstico por imagen , Estenosis de la Válvula Aórtica/economía , Estenosis de la Válvula Aórtica/mortalidad , Análisis Costo-Beneficio , Bases de Datos Factuales , Femenino , Implantación de Prótesis de Válvulas Cardíacas/efectos adversos , Implantación de Prótesis de Válvulas Cardíacas/economía , Implantación de Prótesis de Válvulas Cardíacas/mortalidad , Costos de Hospital , Mortalidad Hospitalaria , Humanos , Fallo Renal Crónico/diagnóstico , Fallo Renal Crónico/economía , Fallo Renal Crónico/mortalidad , Tiempo de Internación , Masculino , Persona de Mediana Edad , Alta del Paciente , Complicaciones Posoperatorias/mortalidad , Diálisis Renal/efectos adversos , Diálisis Renal/economía , Diálisis Renal/mortalidad , Factores de Riesgo , Factores de Tiempo , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Reemplazo de la Válvula Aórtica Transcatéter/economía , Reemplazo de la Válvula Aórtica Transcatéter/mortalidad , Resultado del Tratamiento , Estados UnidosRESUMEN
The American College of Cardiology collaborated with the American Association for Thoracic Surgery, American Heart Association, American Society of Echocardiography, European Association for Cardio-Thoracic Surgery, Heart Valve Society, Society of Cardiovascular Anesthesiologists, Society for Cardiovascular Angiography and Interventions, Society of Cardiovascular Computed Tomography, Society for Cardiovascular Magnetic Resonance, and Society of Thoracic Surgeons to develop and evaluate Appropriate Use Criteria (AUC) for the treatment of patients with severe aortic stenosis (AS). This is the first AUC to address the topic of AS and its treatment options, including surgical aortic valve replacement (SAVR) and transcatheter aortic valve replacement (TAVR). A number of common patient scenarios experienced in daily practice were developed along with assumptions and definitions for those scenarios, which were all created using guidelines, clinical trial data, and expert opinion in the field of AS. The 2014 AHA/ACC guideline for the management of patients with valvular heart disease: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines(1) and its 2017 focused update paper (2) were used as the primary guiding references in developing these indications. The writing group identified 95 clinical scenarios based on patient symptoms and clinical presentation, and up to 6 potential treatment options for those patients. A separate, independent rating panel was asked to score each indication from 1 to 9, with 1-3 categorized as "Rarely Appropriate," 4-6 as "May Be Appropriate," and 7-9 as "Appropriate." After considering factors such as symptom status, left ventricular (LV) function, surgical risk, and the presence of concomitant coronary or other valve disease, the rating panel determined that either SAVR or TAVR is Appropriate in most patients with symptomatic AS at intermediate or high surgical risk; however, situations commonly arise in clinical practice in which the indications for SAVR or TAVR are less clear, including situations in which 1 form of valve replacement would appear reasonable when the other is less so, as do other circumstances in which neither intervention is the suitable treatment option. The purpose of this AUC is to provide guidance to clinicians in the care of patients with severe AS by identifying the reasonable treatment and intervention options available based on the myriad clinical scenarios with which patients present. This AUC document also serves as an educational and quality improvement tool to identify patterns of care and reduce the number of rarely appropriate interventions in clinical practice.