Asunto(s)
Estenosis de la Válvula Aórtica , Reemplazo de la Válvula Aórtica Transcatéter , Humanos , Reemplazo de la Válvula Aórtica Transcatéter/tendencias , Reemplazo de la Válvula Aórtica Transcatéter/historia , Estenosis de la Válvula Aórtica/cirugía , Válvula Aórtica/cirugía , Historia del Siglo XXI , Historia del Siglo XX , Resultado del Tratamiento , Prótesis Valvulares CardíacasRESUMEN
BACKGROUND: Inflammation following transcatheter aortic valve implantation (TAVI) is associated with an increased risk of adverse outcomes. The aim of this study was to compare the inflammatory response between low radial force valves (Acurate neo2, Boston Scientific) and high radial force valves (Evolut R/Pro, Medtronic; SAPIEN Edwards Lifesciences; and Myval, Meril valves). METHODS: We conducted a retrospective study of patients with severe aortic stenosis treated with TAVI between 2021 and 2022. The primary endpoint was the difference in the inflammatory response between low radial force valves and high radial force valves, measured as the difference between post-procedural and pre-procedural high-sensitivity C-reactive protein levels (hsCRP delta). RESULTS: A total of 114 patients were included, of which 65 patients (57%) received a low radial force valve. The hsCRP delta was lower in the low radial force valve group compared to the high radial force valve group (8.7 [2.1-15.6] mg/L vs. 18.8 mg/dL [6.4-19] mg/L; P=0.003), due to a lower post-implantation hsCRP (8.9 [5.45-19.6] mg/L vs. 15.8 [9.8-27.3] mg/L; P=0.013). The incidence of new left bundle branch block (LBBB) after TAVI was lower in the low radial force valve group compared to the high radial force valve group (11 [17%] vs. 18 [37%]; P=0.020). CONCLUSIONS: Low radial force TAVI prostheses were associated with a lower inflammatory response, and a lower incidence of new LBBB compared to the radial force valve group, suggesting that inflammation may contribute to the increased risk of conduction disturbances.
Asunto(s)
Estenosis de la Válvula Aórtica , Proteína C-Reactiva , Prótesis Valvulares Cardíacas , Inflamación , Índice de Severidad de la Enfermedad , Reemplazo de la Válvula Aórtica Transcatéter , Humanos , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Estenosis de la Válvula Aórtica/cirugía , Masculino , Femenino , Estudios Retrospectivos , Anciano de 80 o más Años , Inflamación/etiología , Proteína C-Reactiva/análisis , Proteína C-Reactiva/metabolismo , Anciano , Prótesis Valvulares Cardíacas/efectos adversos , Diseño de Prótesis , Resultado del TratamientoRESUMEN
BACKGROUND: Degenerative severe aortic valve stenosis (AS) is increasingly prevalent in the aging population, leading to the adoption of transcatheter aortic valve replacement (TAVR) as a less invasive alternative. While TAVR indications have expanded, the procedure is associated with a substantial incidence of major adverse cardiac events (MACE). The study aims to establish a preoperative risk-stratification system for TAVR candidates based on Sokolow-Lyon voltage (SLV) and other relevant factors. METHODS: A total of 181 consecutive patients who underwent TAVR were retrospectively reviewed. Baseline characteristics, preoperative electrocardiogram (ECG) and echocardiography findings, and TAVR procedures were assessed. Low SLV (<3.5 mV) was defined based on ECG measurements. RESULTS: Baseline characteristics revealed a mean age of 84 years, with 71.8% females. The two-year incidence of MACE defined as a composite of cardiac death and hospitalization due to heart failure, was 11.6%, significantly higher in the low SLV group. Low SLV emerged as an independent prognostic factor. The Tokyo Bay Risk (TBR) Score, including low SLV, Body Mass Index <18.5 kg/m2, and previous coronary artery disease, effectively stratified MACE risk. Higher TBR scores (2 or 3) correlated with increased MACE risk. CONCLUSIONS: Patients with low SLV in pre-procedural ECG demonstrated a heightened risk of two-year MACE. The TBR score, incorporating low SLV, proved valuable for preoperative risk assessment. Careful consideration of TAVR indications, along with TBR score integration, is crucial for optimizing outcomes.
Asunto(s)
Estenosis de la Válvula Aórtica , Electrocardiografía , Reemplazo de la Válvula Aórtica Transcatéter , Humanos , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Femenino , Masculino , Anciano de 80 o más Años , Estenosis de la Válvula Aórtica/cirugía , Estudios Retrospectivos , Anciano , Medición de Riesgo , Ecocardiografía , Factores de Riesgo , Índice de Severidad de la Enfermedad , Complicaciones Posoperatorias/epidemiología , Complicaciones Posoperatorias/etiología , Válvula Aórtica/cirugía , IncidenciaRESUMEN
BACKGROUND: Large datasets of transcatheter aortic valve implantation (TAVI) for pure aortic valve regurgitation (PAVR) are scarce. AIMS: We aimed to report procedural safety and long-term clinical events (CE) in a contemporary cohort of PAVR patients treated with new-generation devices (NGD). METHODS: Patients with grade III/IV PAVR enrolled in the FRANCE-TAVI Registry were selected. The primary safety endpoint was technical success (TS) according to Valve Academic Research Consortium 3 criteria. The co-primary endpoint was defined as a composite of mortality, heart failure hospitalisation and valve reintervention at last follow-up. RESULTS: From 2015 to 2021, 227 individuals (64.3% males, median age 81.0 [interquartile range {IQR} 73.5-85.0] years, with EuroSCORE II 6.0% [IQR 4.0-10.9]) from 41 centres underwent TAVI with NGD, using either self-expanding (55.1%) or balloon-expandable valves (44.9%; p=0.50). TS was 85.5%, with a non-significant trend towards increased TS in high-volume activity centres. A second valve implantation (SVI) was needed in 8.8% of patients, independent of valve type (p=0.82). Device size was ≥29 mm in 73.0% of patients, post-procedure grade ≥III residual aortic regurgitation was rare (1.2%), and the permanent pacemaker implantation (PPI) rate was 36.0%. At 30 days, the incidences of mortality and reintervention were 8.4% and 3.5%, respectively. The co-primary endpoint reached 41.6% (IQR 34.4-49.6) at 1 year, increased up to 61.8% (IQR 52.4-71.2) at 4 years, and was independently predicted by TS, with a hazard ratio of 0.45 (95% confidence interval: 0.27-0.76); p=0.003. CONCLUSIONS: TAVI with NGD in PAVR patients is efficient and reasonably safe. Preventing the need for an SVI embodies the major technical challenge. Larger implanted valves may have limited this complication, outweighing the increased risk of PPI. Despite successful TAVI, PAVR patients experience frequent CE at long-term follow-up.
Asunto(s)
Insuficiencia de la Válvula Aórtica , Prótesis Valvulares Cardíacas , Sistema de Registros , Reemplazo de la Válvula Aórtica Transcatéter , Humanos , Reemplazo de la Válvula Aórtica Transcatéter/métodos , Reemplazo de la Válvula Aórtica Transcatéter/instrumentación , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Reemplazo de la Válvula Aórtica Transcatéter/mortalidad , Insuficiencia de la Válvula Aórtica/cirugía , Masculino , Femenino , Anciano , Anciano de 80 o más Años , Resultado del Tratamiento , Válvula Aórtica/cirugía , Válvula Aórtica/diagnóstico por imagen , Factores de Riesgo , FranciaRESUMEN
Aortic regurgitation (AR) is a common clinical disease associated with significant morbidity and mortality. Investigations based largely on non-invasive imaging are pivotal in discerning the severity of disease and its impact on the heart. Advances in technology have contributed to improved risk stratification and to our understanding of the pathophysiology of AR. Surgical aortic valve replacement is the predominant treatment. However, its use is limited to patients with an acceptable surgical risk profile. Transcatheter aortic valve implantation is an alternative treatment. However, this therapy remains in its infancy, and further data and experience are required. This review article on AR describes its prevalence, mechanisms, diagnosis and treatment.
Asunto(s)
Insuficiencia de la Válvula Aórtica , Válvula Aórtica , Implantación de Prótesis de Válvulas Cardíacas , Reemplazo de la Válvula Aórtica Transcatéter , Humanos , Insuficiencia de la Válvula Aórtica/fisiopatología , Insuficiencia de la Válvula Aórtica/terapia , Insuficiencia de la Válvula Aórtica/cirugía , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Implantación de Prótesis de Válvulas Cardíacas/métodos , Implantación de Prótesis de Válvulas Cardíacas/efectos adversos , Implantación de Prótesis de Válvulas Cardíacas/instrumentación , Válvula Aórtica/cirugía , Válvula Aórtica/fisiopatología , Válvula Aórtica/diagnóstico por imagen , Resultado del Tratamiento , Prótesis Valvulares CardíacasAsunto(s)
Estenosis de la Válvula Aórtica , Prótesis Valvulares Cardíacas , Reemplazo de la Válvula Aórtica Transcatéter , Humanos , Válvula Aórtica/cirugía , Válvula Aórtica/diagnóstico por imagen , Estenosis de la Válvula Aórtica/cirugía , Estenosis de la Válvula Aórtica/diagnóstico por imagen , Diseño de Prótesis , Reemplazo de la Válvula Aórtica Transcatéter/instrumentación , Ventrículos Cardíacos/anatomía & histología , Aorta Torácica/anatomía & histología , Estudios de Equivalencia como AsuntoAsunto(s)
Estenosis de la Válvula Aórtica , Prótesis Valvulares Cardíacas , Reemplazo de la Válvula Aórtica Transcatéter , Humanos , Válvula Aórtica/cirugía , Válvula Aórtica/diagnóstico por imagen , Estenosis de la Válvula Aórtica/cirugía , Estenosis de la Válvula Aórtica/diagnóstico por imagen , Diseño de Prótesis , Reemplazo de la Válvula Aórtica Transcatéter/instrumentación , Ventrículos Cardíacos/anatomía & histología , Aorta Torácica/anatomía & histología , Estudios de Equivalencia como AsuntoAsunto(s)
Estenosis de la Válvula Aórtica , Prótesis Valvulares Cardíacas , Reemplazo de la Válvula Aórtica Transcatéter , Humanos , Válvula Aórtica/cirugía , Válvula Aórtica/diagnóstico por imagen , Estenosis de la Válvula Aórtica/cirugía , Estenosis de la Válvula Aórtica/diagnóstico por imagen , Diseño de Prótesis , Reemplazo de la Válvula Aórtica Transcatéter/instrumentación , Aorta Torácica/anatomía & histología , Estudios de Equivalencia como Asunto , Ventrículos Cardíacos/anatomía & histologíaRESUMEN
Congenital Quadricuspid Aortic Valve (QAV) malformation is a relatively rare cardiac valve malformation, especially with abnormal coronary opening and severe stenosis of Coronary Artery Disease (CAD). The patient underwent "one-stop" interventional treatment with transcatheter aortic valve replacement and percutaneous coronary stent implantation. Follow up for 12-month with good outcomes.
Asunto(s)
Válvula Aórtica , Enfermedad de la Arteria Coronaria , Reemplazo de la Válvula Aórtica Transcatéter , Humanos , Válvula Aórtica/cirugía , Válvula Aórtica/anomalías , Válvula Aórtica/diagnóstico por imagen , Enfermedad de la Arteria Coronaria/cirugía , Enfermedad de la Arteria Coronaria/complicaciones , Reemplazo de la Válvula Aórtica Transcatéter/métodos , Masculino , Stents , Intervención Coronaria Percutánea/métodos , Angiografía Coronaria , AncianoRESUMEN
BACKGROUND: Paravalvular regurgitation (PVR) is a common complication after transcatheter aortic valve replacement, posing an increased risk of heart failure and mortality. Accurate intraprocedural quantification of PVR is challenging. Both hemodynamic indices and videodensitometry can be used for intraprocedural assessment of PVR. We compared the predictive value of the isolated versus combined use of the hemodynamic index diastolic delta (DD) and videodensitometry for the incidence of relevant PVR 1 month after transcatheter aortic valve replacement. METHODS AND RESULTS: In this prospective cohort study, patients underwent periprocedural PVR assessment by DD and videodensitometry (using left ventricular outflow tract-aortic regurgitation [LVOT-AR]). Cardiac magnetic resonance served as reference modality for PVR assessment. Relevant PVR was defined as cardiac magnetic resonance-regurgitant fraction >20%. Fifty-one patients were enrolled in this study. Mean age was 80.6±5.2 years and 45.1% of patients were men. Mean LVOT-AR and cardiac magnetic resonance-regurgitant fraction were 8.2%±7.8% and 11.7%±9.6%, respectively. The correlation between DD and LVOT-AR was weak (r=-0.36). DD and LVOT-AR showed a comparable accuracy to predict relevant PVR (area under the curve 0.82, 95% CI: 0.69-0.95 versus area area under the time-density curve 0.80, 95% CI: 0.62-0.99). The combination of DD and LVOT-AR improved the prediction of relevant PVR (area under the time-density curve, 0.90, 95% CI: 0.81-0.99), and resulted in an increased concordance (86.3%) and positive predictive value (75%) compared with DD alone (76.5% and 40%, respectively), or LVOT-AR alone (82.3% and 50%, respectively). CONCLUSIONS: DD and videodensitometry are both accurate and feasible modalities for the assessment of PVR after transcatheter aortic valve replacement. The synergistic use of both techniques increases the predictive value for relevant PVR after transcatheter aortic valve replacement. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT04281771.
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Insuficiencia de la Válvula Aórtica , Valor Predictivo de las Pruebas , Reemplazo de la Válvula Aórtica Transcatéter , Humanos , Masculino , Femenino , Insuficiencia de la Válvula Aórtica/etiología , Insuficiencia de la Válvula Aórtica/fisiopatología , Insuficiencia de la Válvula Aórtica/diagnóstico , Insuficiencia de la Válvula Aórtica/diagnóstico por imagen , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Estudios Prospectivos , Anciano de 80 o más Años , Anciano , Estenosis de la Válvula Aórtica/cirugía , Estenosis de la Válvula Aórtica/fisiopatología , Válvula Aórtica/cirugía , Válvula Aórtica/diagnóstico por imagen , Válvula Aórtica/fisiopatología , Hemodinámica/fisiología , Diástole , Resultado del Tratamiento , Complicaciones Posoperatorias/etiología , Complicaciones Posoperatorias/diagnósticoAsunto(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/instrumentación , Estenosis de la Válvula Aórtica/cirugía , Insuficiencia de la Válvula Aórtica/etiología , Insuficiencia de la Válvula Aórtica/cirugía , Válvula Aórtica/cirugía , Válvula Aórtica/diagnóstico por imagen , Prótesis Valvulares Cardíacas/efectos adversos , Complicaciones Posoperatorias/etiología , Complicaciones Posoperatorias/diagnóstico , MasculinoRESUMEN
Surgical aortic valve replacement (SAVR) and transcatheter aortic valve implantation (TAVI) are options in severe aortic valve stenosis (AVS). Cardiovascular (CV) and cerebrovascular (CBV) control markers, derived from variability of heart period, systolic arterial pressure, mean cerebral blood velocity and mean arterial pressure, were acquired in 19 AVS patients (age: 76.8 ± 3.1 yrs, eight males) scheduled for SAVR and in 19 AVS patients (age: 79.9 + 6.5 yrs, 11 males) scheduled for TAVI before (PRE) and after intervention (POST, <7 days). Left ventricular function was preserved in both groups. Patients were studied at supine resting (REST) and during active standing (STAND). We found that: (i) both SAVR and TAVI groups featured a weak pre-procedure CV control; (ii) TAVI ensured better CV control; (iii) cerebral autoregulation was working in PRE in both SAVR and TAVI groups; (iv) SAVR and TAVI had no impact on the CBV control; (v) regardless of group, CV and CBV control markers were not influenced by STAND in POST. Even though the post-procedure preservation of both CV and CBV controls in TAVI group might lead to privilege this procedure in patients at higher risk, the missing response to STAND suggests that this advantage could be insignificant.
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Estenosis de la Válvula Aórtica , Circulación Cerebrovascular , Reemplazo de la Válvula Aórtica Transcatéter , Humanos , Masculino , Femenino , Anciano , Reemplazo de la Válvula Aórtica Transcatéter/métodos , Proyectos Piloto , Estenosis de la Válvula Aórtica/cirugía , Estenosis de la Válvula Aórtica/fisiopatología , Circulación Cerebrovascular/fisiología , Anciano de 80 o más Años , Válvula Aórtica/cirugía , Válvula Aórtica/fisiopatología , Implantación de Prótesis de Válvulas Cardíacas/métodosAsunto(s)
Insuficiencia 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 , Insuficiencia de la Válvula Aórtica/cirugía , Insuficiencia de la Válvula Aórtica/diagnóstico por imagen , Insuficiencia de la Válvula Aórtica/fisiopatología , Válvula Aórtica/cirugía , Válvula Aórtica/diagnóstico por imagen , Resultado del Tratamiento , Estenosis de la Válvula Aórtica/cirugía , Estenosis de la Válvula Aórtica/fisiopatología , Estenosis de la Válvula Aórtica/diagnóstico por imagen , Índice de Severidad de la Enfermedad , Prótesis Valvulares CardíacasAsunto(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 , Estenosis de la Válvula Aórtica/cirugía , Oclusión Coronaria/prevención & control , Oclusión Coronaria/cirugía , Oclusión Coronaria/terapia , Prótesis Valvulares Cardíacas , Válvula Aórtica/cirugía , Resultado del Tratamiento , Diseño de PrótesisAsunto(s)
Estenosis de la Válvula Aórtica , Fibrilación Atrial , Reemplazo de la Válvula Aórtica Transcatéter , Humanos , Fibrilación Atrial/etiología , Fibrilación Atrial/fisiopatología , Fibrilación Atrial/diagnóstico , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Estenosis de la Válvula Aórtica/cirugía , Resultado del Tratamiento , Válvula Aórtica/cirugía , Válvula Aórtica/diagnóstico por imagen , Válvula Aórtica/fisiopatología , Factores de RiesgoAsunto(s)
Estenosis de la Válvula Aórtica , Prótesis Valvulares Cardíacas , Reemplazo de la Válvula Aórtica Transcatéter , Humanos , Aorta Torácica/anatomía & histología , Válvula Aórtica/diagnóstico por imagen , Válvula Aórtica/cirugía , Estenosis de la Válvula Aórtica/cirugía , Estenosis de la Válvula Aórtica/diagnóstico por imagen , Estudios de Equivalencia como Asunto , Ventrículos Cardíacos/anatomía & histología , Diseño de Prótesis , Reemplazo de la Válvula Aórtica Transcatéter/instrumentaciónAsunto(s)
Valor Predictivo de las Pruebas , Reemplazo de la Válvula Aórtica Transcatéter , Humanos , Resultado del Tratamiento , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Factores de Riesgo , Válvula Aórtica/cirugía , Válvula Aórtica/diagnóstico por imagen , Válvula Aórtica/fisiopatología , Prótesis Valvulares Cardíacas , Factores de TiempoRESUMEN
BACKGROUND: Research on the role of transcatheter heart valve (THV) deformation and calcium distribution in patients with bicuspid aortic valves (BAVs) undergoing transcatheter aortic valve replacement (TAVR) remains limited. OBJECTIVES: The aim of this study was to evaluate the impact of THV deformation on clinical outcomes in individuals with BAVs undergoing TAVR and the influence of calcium on these outcomes. METHODS: In total, 229 consecutive patients with BAVs who underwent TAVR with balloon-expandable valves and had computed tomography (CT) performed 30 days post-TAVR were analyzed. Patients were stratified into 3 groups: group 1 (n = 125), with no THV underexpansion or eccentricity; group 2 (n = 69), with underexpansion or eccentricity; and group 3 (n = 35), with both. Calcium distribution was assessed using CT, and its associations with clinical outcomes, including all-cause mortality at 3 years and leaflet thrombosis at 30 days, were determined. A subgroup analysis of patients with type 1 BAVs was conducted. RESULTS: Group 3 exhibited higher rates of all-cause mortality than the other groups, along with the highest risk for hypoattenuated leaflet thickening at 30 days. Multivariate analysis identified annular and left ventricular outflow tract calcification as independent predictors of all-cause mortality and hypoattenuated leaflet thickening. In patients with type 1 BAVs, excessive calcification at the raphe and opposite leaflet were associated with all-cause mortality at 3 years. CONCLUSIONS: THV deformation post-TAVR was significantly linked to all-cause mortality in patients with BAVs. Annular and left ventricular outflow tract calcification correlated with increased risks for all-cause mortality and leaflet thrombosis. (Assessment of Transcatheter and Surgical Aortic Bioprosthetic Valve Thrombosis and Its Treatment With Anticoagulation [RESOLVE]; NCT02318342).
Asunto(s)
Estenosis de la Válvula Aórtica , Válvula Aórtica , Valvuloplastia con Balón , Enfermedad de la Válvula Aórtica Bicúspide , Calcinosis , Enfermedades de las Válvulas Cardíacas , Prótesis Valvulares Cardíacas , Diseño de Prótesis , Reemplazo de la Válvula Aórtica Transcatéter , Humanos , Masculino , Femenino , Enfermedad de la Válvula Aórtica Bicúspide/diagnóstico por imagen , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Reemplazo de la Válvula Aórtica Transcatéter/mortalidad , Reemplazo de la Válvula Aórtica Transcatéter/instrumentación , Anciano , Anciano de 80 o más Años , Válvula Aórtica/diagnóstico por imagen , Válvula Aórtica/cirugía , Válvula Aórtica/fisiopatología , Válvula Aórtica/anomalías , Resultado del Tratamiento , Factores de Riesgo , Factores de Tiempo , Calcinosis/diagnóstico por imagen , Calcinosis/fisiopatología , Calcinosis/mortalidad , Valvuloplastia con Balón/efectos adversos , Estenosis de la Válvula Aórtica/diagnóstico por imagen , Estenosis de la Válvula Aórtica/fisiopatología , Estenosis de la Válvula Aórtica/cirugía , Estenosis de la Válvula Aórtica/mortalidad , Enfermedades de las Válvulas Cardíacas/diagnóstico por imagen , Enfermedades de las Válvulas Cardíacas/fisiopatología , Enfermedades de las Válvulas Cardíacas/cirugía , Enfermedades de las Válvulas Cardíacas/mortalidad , Estudios Retrospectivos , Medición de Riesgo , Trombosis/diagnóstico por imagen , Trombosis/etiología , Tomografía Computarizada Multidetector , Valor Predictivo de las PruebasRESUMEN
BACKGROUND: Fluid overload (FO) subjects patients with severe aortic stenosis (AS) to increased risk for heart failure and death after valve replacement and can be objectively quantified using bioimpedance spectroscopy (BIS). OBJECTIVES: The authors hypothesized that in AS patients with concomitant FO, BIS-guided decongestion could improve prognosis and quality of life following transcatheter aortic valve replacement (TAVR). METHODS: This randomized, controlled trial enrolled 232 patients with severe AS scheduled for TAVR. FO was defined using a portable whole-body BIS device according to previously established cutoffs (≥1.0 L and/or ≥7%). Patients with FO (n = 111) were randomly assigned 1:1 to receive BIS-guided decongestion (n = 55) or decongestion by clinical judgment alone (n = 56) following TAVR. Patients without FO (n = 121) served as a control cohort. The primary endpoint was the composite of hospitalization for heart failure and/or all-cause death at 12 months. The secondary endpoint was the change from baseline to 12 months in the Kansas City Cardiomyopathy Questionnaire. RESULTS: The occurrence of the primary endpoint at 12 months was significantly lower in the BIS-guided vs the non-BIS-guided decongestion group (7/55 [12.7%, all deaths] vs 18/56 [32.1%, 9 hospitalizations for heart failure and 9 deaths]; HR: 0.36; 95% CI: 0.15-0.87; absolute risk reduction = -19.4%). Outcomes in the BIS-guided decongestion group were identical to the euvolemic control group (log-rank test, P = 0.7). BIS-guided decongestion was also associated with a higher increase in the Kansas City Cardiomyopathy Questionnaire score from baseline compared to non-BIS-guided decongestion (P = 0.001). CONCLUSIONS: In patients with severe AS and concomitant FO, quantitatively guided decongestive treatment and associated intensified management post-TAVR was associated with improved outcomes and quality of life compared to decongestion by clinical judgment alone. (Management of Fluid Overload in Patients Scheduled for Transcatheter Aortic Valve Replacement [EASE-TAVR]; NCT04556123).