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AIMS: We aimed to evaluate transcatheter mitral valve implantation (TMVI) using predominantly balloon-expandable transcatheter heart valves (THV) in patients with a landing zone for a percutaneously delivered prosthesis. BACKGROUND: Patients with a degenerated mitral valve bioprosthesis, annuloplasty ring, and mitral annulus calcification (MAC) considered at high surgical risk currently represent a treatment challenge. TMVI is an alternative treatment option. METHODS: Retrospective analysis of patients with symptomatic degenerated mitral valve bioprosthesis, or annuloplasty ring, and MAC treated with TMVI between November 2011 and April 2021. Endpoints were defined according to Mitral Valve Academic Research Consortium (MVARC) criteria and included device and procedure success at 30 days as well as mortality at 30 days and 1 year after the procedure. RESULTS: A total of 77 patients underwent TMVI (valve in valve [ViV = 56], valve in ring [ViR = 11], and valve in MAC [ViMAC = 10]). There was a trend toward higher technical success (all = 93.5%, ViV = 96.4%, ViR = 90.9%, ViMAC = 80%, p = 0.06) and lower 30-day (all = 11.7%, ViV = 10.7%, ViR = 9.1%, ViMAC = 20%, p = 0.49) and 1-year mortality (all = 26%, ViV = 23.2%, ViR = 27.3%, ViMAC= 40%, p = 0.36) after ViV and ViR compared to ViMAC. CONCLUSION: TMVI represents a reasonable treatment option in selected patients with MAC or who are poor candidates for redo mitral valve surgery. Technical success and survival up to 1 year were not significantly dependent on the subgroup in which TMVI was performed.
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Background: The interplay between the right ventricle and the pulmonary artery, known as right ventricular to pulmonary artery (RV-PA) coupling, is crucial for assessing right ventricular systolic function against the afterload from the pulmonary circulation. Pulmonary artery pressure levels are ideally measured by right heart catheterization. Yet, echocardiography represents the most utilized method for evaluating pulmonary artery pressure levels, albeit with limitations in accuracy. This study therefore aims to evaluate the prognostic significance of right ventricular to pulmonary artery (RV-PA) coupling expressed as tricuspid annular plane systolic excursion (TAPSE) related to systolic pulmonary artery pressure (sPAP) levels measured by right heart catheterization (TAPSE/sPAPinvasive) or estimated by transthoracic echocardiography (TAPSE/sPAPechocardiography) in patients with severe aortic stenosis undergoing transcatheter aortic valve replacement (TAVR). Methods: Using data from a bicentric registry, this study compares TAPSE/sPAPinvasive vs. TAPSE/sPAPechocardiography in predicting 1-year all-cause mortality after TAVR. Results: Among 333 patients with complete echocardiography and right heart catheterization data obtained before TAVR, their mean age was 79.8 ± 6.74 years, 39.6% were female, and general 1-year survival was 89.8%. sPAPinvasive and sPAPechocardiography showed only moderate correlation (Pearson correlation coefficient R: 0.53, p value: <0.0001). TAPSE/sPAPinvasive was superior to TAPSE/sPAPechocardiography in predicting 1-year all-cause mortality after TAVR (area under the curve: 0.662 vs. 0.569, p value: 0.025). Patients with reduced TAPSE/sPAPinvasive levels (< 0.365 mm/mmHg) evidenced significantly lower 1-year survival rates than patients with preserved TAPSE/sPAPinvasive levels (81.8 vs. 93.6%, p value: 0.001; hazard ratio for 1-year mortality: 3.09 [95% confidence interval: 1.55-6.17]). Echocardiographic follow-up data revealed that patients with reduced RV-PA coupling suffer from persistent right ventricular dysfunction (TAPSE: 16.6 ± 4.05 mm vs. 21.6 ± 4.81 mm in patients with preserved RV-PA coupling) and severe tricuspid regurgitation (diagnosed in 19.7 vs. 6.58% in patients with preserved RV-PA coupling). Conclusions: RV-PA coupling expressed as TAPSE/sPAPinvasive can refine stratification of severe aortic stenosis patients into low-risk and high-risk cohorts for mortality after TAVR. Moreover, it can help to anticipate persistent extra-aortic valve cardiac damage, which will demand further treatment.
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Aortic valve stenosis is one of the most frequent valvular heart diseases requiring treatment in industrialized countries. The symptom onset is associated with a significantly increased mortality, so that there is a clear indication for treatment in patients with severe, symptomatic aortic valve stenosis; however, data on the optimal treatment of patients with asymptomatic aortic valve stenosis are scarce. Smaller studies in the field of cardiac surgery suggest that early surgical valve replacement is superior to a conservative approach. For this reason, the results of additional adequately powered randomized trials are awaited with great interest. In this year numerous long-term results from randomized comparisons of the two available treatment options (surgical versus transcatheter aortic valve replacement) were published, which will further guide the heart team to find the best treatment approach for each individual.
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Estenosis de la Válvula Aórtica , Enfermedades de las Válvulas Cardíacas , Implantación de Prótesis de Válvulas Cardíacas , Prótesis Valvulares Cardíacas , Reemplazo de la Válvula Aórtica Transcatéter , Humanos , Estenosis de la Válvula Aórtica/diagnóstico , Estenosis de la Válvula Aórtica/cirugía , Enfermedades de las Válvulas Cardíacas/cirugía , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Implantación de Prótesis de Válvulas Cardíacas/métodos , Válvula Aórtica/diagnóstico por imagen , Válvula Aórtica/cirugía , Resultado del Tratamiento , Factores de RiesgoRESUMEN
BACKGROUND: ACURATE neo2 (Neo2) implantation is performed after systematic Balloon Aortic Valvuloplasty (BAV) in most patients. No reports exist about the feasibility and safety of direct Neo2 transcatheter aortic valve implantation (TAVI) in comparison to the standard practice. AIM: We aimed to identify the patients' baseline anatomical characteristics, procedural, and early post-procedural outcomes in patients treated using Neo2 with and without BAV. METHODOLOGY: This is a retrospective multicentre analysis of 499 patients with severe aortic stenosis who underwent TAVI using Neo2. The comparison was done according to the performance or omission of BAV. Echocardiography and computed tomography were analysed by an independent Core Lab. Propensity score matching (PSM) was performed based on the annular diameter and AV calcium volume, which identified 84 matched pairs. RESULTS: Among the cohort included, 391 (78%) patients received BAV (BAV-yes) and 108 (22%) were not attempted (BAV-no or Direct TAVI). Patients in BAV-no cohort had smaller annular diameter (22.6 vs 23.4 mm; p < 0.001) and lower calcium volume (163 vs 581 mm3; p < 0.001) compared to BAV-yes cohort. In the matched cohort, VARC-3 device technical success was similar (95%) and all other outcome measures were statistically comparable between cohorts. CONCLUSION: Direct TAVI using ACURATEneo2 without pre-TAVI balloon aortic valvuloplasty in patients with mild or less valve calcifications might be feasible and associated with comparable early outcomes compared to patients with similar anatomical features undergoing systematic balloon valvuloplasty.
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Estenosis de la Válvula Aórtica , Valvuloplastia con Balón , Prótesis Valvulares Cardíacas , Reemplazo de la Válvula Aórtica Transcatéter , Humanos , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Válvula Aórtica/diagnóstico por imagen , Válvula Aórtica/cirugía , Estenosis de la Válvula Aórtica/diagnóstico por imagen , Estenosis de la Válvula Aórtica/cirugía , Valvuloplastia con Balón/métodos , Calcio , Resultado del Tratamiento , Estudios Retrospectivos , Diseño de PrótesisRESUMEN
BACKGROUND: Procedural improvements combined with the contemporary clinical profile of patients undergoing transcatheter aortic valve replacement (TAVR) may have influenced the incidence and outcomes of infective endocarditis (IE) following TAVR. We aimed to determine the temporal trends, characteristics, and outcomes of IE post-TAVR. METHODS: Observational study including 552 patients presenting definite IE post-TAVR. Patients were divided in 2 groups according to the timing of TAVR (historical cohort [HC]: before 2014; contemporary cohort [CC]: after 2014). RESULTS: Overall incidence rates of IE were similar in both cohorts (CC vs HC: 5.45 vs 6.52 per 1000 person-years; P = .12), but the rate of early IE was lower in the CC (2.29 vs 4.89, P < .001). Enterococci were the most frequent microorganism. Most patients presented complicated IE (CC: 67.7%; HC: 69.6%; P = .66), but the rate of surgical treatment remained low (CC: 20.7%; HC: 17.3%; P = .32). The CC exhibited lower rates of in-hospital acute kidney injury (35.1% vs 44.6%; P = .036) and in-hospital (26.6% vs 36.4%; P = .016) and 1-year (37.8% vs 53.5%; P < .001) mortality. Higher logistic EuroScore, Staphylococcus aureus etiology, and complications (stroke, heart failure, and acute renal failure) were associated with in-hospital mortality in multivariable analyses (P < .05 for all). CONCLUSIONS: Although overall IE incidence has remained stable, the incidence of early IE has declined in recent years. The microorganism, high rate of complications, and very low rate of surgical treatment remained similar. In-hospital and 1-year mortality rates were high but progressively decreased over time.
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Endocarditis , Reemplazo de la Válvula Aórtica TranscatéterRESUMEN
Introducción y objetivos: La galectina-3 (Gal-3) y el antígeno carbohidrato 125 (CA125) han mostrado relación con eventos adversos tras el implante percutáneo de válvula aórtica (TAVI). Datos experimentales indican que podrían tener cierta interacción molecular. El objetivo del presente estudio es establecer la asociación de Gal-3 y CA125 con el pronóstico tras el TAVI. Métodos: Se incluyó en total a 439 pacientes. El objetivo primario fue el compuesto de mortalidad por todas las causas o reingreso por insuficiencia cardiaca tras el TAVI. Resultados: El objetivo primario se produjo en el 16,4% de la muestra. Los valores de Gal-3 se dicotomizaron en elevados (≥ 8,71 ng/ml) y no elevados. Los pacientes con Gal-3 elevado (31,9%) presentaron mayor riego de sufrir el objetivo primario (el 25 frente al 12,4%; HR=2,26; p<0,001). Tras el ajuste multivariable, la asociación entre Gal-3 y el pronóstico se situó en el límite de la significación (HR=1,59; p=0,068). En consecuencia, el CA125 se dicotomizó en ≥ 18,4 U/ml. El CA125 estaba elevado en el 51,9% y también se asoció con mayor riesgo del objetivo primario (el 25,4 frente al 6,6%; HR=4,20; p<0,001). Tras el ajuste multivariable, los valores de CA125 elevados (HR=2,83; p=0,001) mantenían la asociación independiente con el riesgo del objetivo primario. Se observó un efecto pronóstico diferencial para Gal-3 según los valores de CA125 (p de interacción=0,048). Así, los valores de Gal-3 elevados se asociaron significativamente con el pronóstico de los pacientes con CA125 elevado (el 38,8 frente al 18,2%; HR=2,02; p=0,015). Por el contrario, el Gal-3 no aportó información pronóstica con valores de CA125 bajos (el 6,6 frente al 6,7%; HR=1,16; p=0,981). Conclusiones: En pacientes sometidos a TAVI, los valores de Gal-3 se asociaron con mayor riesgo de eventos adversos clínicos solamente en presencia de valores de CA125 elevados
Introduction and objectives: Galectin-3 (Gal-3) and carbohydrate antigen 125 (CA125) have been associated with adverse outcomes after transcatheter aortic valve implantation (TAVI). Experimental data have suggested a potential molecular interaction. Therefore, we assessed the association of Gal-3 and CA125 with prognosis after TAVI. Methods: A total of 439 patients were enrolled. The primary endpoint was a composite of all-cause mortality or readmission for worsening heart failure after TAVI. Results: The primary endpoint occurred in 16.4%. Gal-3 was dichotomized at ≥ 8.71 ng/mL into elevated and not elevated. Gal-3 was elevated in 31.9% and was associated with a higher risk of the primary endpoint (25% vs 12.4%, HR, 2.26; P<.001). After multivariable adjustment, the association of elevated Gal-3 with the primary endpoint was borderline significant (HR, 1.59; P=.068). CA125 was dichotomized at ≥ 18.4 U/mL, accordingly. CA125 was elevated in 51.9% and was also associated with a higher risk of the primary endpoint (25.4% vs 6.6%, HR, 4.20; P<.001). After multivariable adjustment, elevated CA125 (HR, 2.83; P=.001) remained independently associated with the primary endpoint. A differential prognostic effect of Gal-3 was found across CA125 status (P for interaction=.048). Elevated Gal-3 was associated with a higher risk of the primary endpoint when CA125 was elevated (38.8% vs 18.2%, HR, 2.02; P=.015) but lacked significance when CA125 was not elevated (6.6% vs 6.7%, HR, 1.16; P=.981). Conclusions: In patients undergoing TAVI, Gal-3 predicted adverse clinical outcomes only when CA125 was elevated
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Humanos , Masculino , Femenino , Anciano , Anciano de 80 o más Años , Estenosis de la Válvula Aórtica/cirugía , Reemplazo de la Válvula Aórtica Transcatéter/métodos , Galectina 3/sangre , Antígeno Ca-125/sangre , Estenosis de la Válvula Aórtica/sangre , Pronóstico , Selección de Paciente , Análisis de SupervivenciaRESUMEN
BACKGROUND: No data exist about the characteristics of infective endocarditis (IE) post-transcatheter aortic valve replacement (TAVR) according to transcatheter valve type. We aimed to determine the incidence, clinical characteristics, and outcomes of patients with IE post-TAVR treated with balloon-expandable valve (BEV) versus self-expanding valve (SEV) systems. METHODS: Data from the multicenter Infectious Endocarditis After TAVR International Registry was used to compare IE patients with BEV versus SEV. RESULTS: A total of 245 patients with IE post-TAVR were included (SEV, 47%; BEV, 53%). The timing between TAVR and IE was similar between groups (SEV, 5.5 [1.2-15] months versus BEV, 5.3 [1.7-11.4] months; P=0.89). Enterococcal IE was more frequent in the SEV group (36.5% versus 15.4%; P<0.01), and vegetation location differed according to valve type (stent frame, SEV, 18.6%; BEV, 6.9%; P=0.01; valve leaflet, SEV, 23.9%; BEV, 38.5%; P=0.01). BEV recipients had a higher rate of stroke/systemic embolism (20.0% versus 8.7%, adjusted OR: 2.46, 95% CI: 1.04-5.82, P=0.04). Surgical explant of the transcatheter valve (SEV, 8.7%; BEV, 13.8%; P=0.21), and in-hospital death at the time of IE episode (SEV, 35.6%; BEV, 37.7%; P=0.74) were similar between groups. After a mean follow-up of 13±12 months, 59.1% and 54.6% of the SEV and BEV recipients, respectively, had died (P=0.66). CONCLUSIONS: The characteristics of IE post-TAVR, including microorganism type, vegetation location, and embolic complications but not early or late mortality, differed according to valve type. These results may help to guide the diagnosis and management of IE and inform future research studies in the field. (AU)
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Sistema de Registros , Incidencia , Endocarditis , Reemplazo de la Válvula Aórtica TranscatéterRESUMEN
Introducción y objetivos: Para lograr el éxito del dispositivo, se recomienda cierto sobredimensionamiento de la prótesis (SP) SAPIEN 3. Sin embargo, un aumento en el SP puede incrementar las tasas de implante de marcapasos definitivo (IMD). Por lo tanto, se investiga la influencia del SP en el fallo del dispositivo y el IMD. Métodos: Se trató con SAPIEN 3 a 804 pacientes en 3 centros. El SP, determinado mediante tomografía computarizada multicorte, se calculó y analizó como variable continua y categorizada en incrementos del 5%, con -4% a 0 como referencia. Resultados: Se produjo fallo del dispositivo en el 8,8% de los pacientes. La mediana de SP fue menor en los pacientes con fallo del dispositivo que en aquellos con éxito (el +4 frente al +8%; p=0,038). El SP mostró un patrón de riesgo no lineal, con una tasa de fallo del dispositivo significativamente reducida para valores entre el +4 y el +22%. No hubo ningún caso de fuga paravalvular II+ entre un +10 y un +20% de SP. La tasa general de IMD fue del 16,2% y la mediana de SP fue significativamente mayor en los pacientes con IMD (IMD, el +9% frente a no IMD, el +7%; p=0,025), mientras que la profundidad del implante no varió entre pacientes con y sin IMD (6,9+/-1,7 frente a 6,6+/-1,9mm; p=0,101). El riesgo de IMD aumentó con el aumento del SP y fue mayor en las 2 categorías más altas. Conclusiones: El incremento en el SP reduce el riesgo de fallo del dispositivo, pero aumenta el de IMD. No se halló un intervalo de SP ideal para minimizar los riesgos de fallo del dispositivo e IMD
Introduction and objectives: A certain degree of prosthesis oversizing (OS) is recommended for the SAPIEN 3 to achieve device success. However, an increase in OS may increase permanent pacemaker implantation (PPI) rates. We therefore investigated the influence of OS on device failure and PPI. Methods: A total of 804 patients were treated with SAPIEN 3 at 3 centers. Multislice computed tomography-derived OS was calculated and analyzed both as a continuous variable and categorized in 5% increments with −4% to 0% as reference. Results: Device failure occurred in 8.8% of patients. Median OS was lower in patients with device failure vs those with device success (+4% vs +8%; P=.038). A nonlinear risk pattern was shown for OS with a significantly reduced device failure rate within 4% to +22% of OS. There was no case of paravalvular leakage II+ between +10% to +20% of OS. The overall PPI rate was 16.2% and the median OS was significantly larger in patients with PPI (PPI: +9% vs no PPI: +7%; P = .025), while implantation depth did not vary in patients with vs without PPI (6.9+/-1.7 mm vs 6.6+/-1.9 mm; P=.101). The risk of PPI increased with increasing OS and was highest in the 2 highest categories. Conclusions: An increase in OS reduces the risk for device failure but increases the risk for PPI. There was no ideal range of OS to minimize both device failure and PPI
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Humanos , Masculino , Femenino , Anciano , Anciano de 80 o más Años , Reemplazo de la Válvula Aórtica Transcatéter/estadística & datos numéricos , Marcapaso Artificial/estadística & datos numéricos , Falla de Prótesis/efectos adversos , Estenosis de la Válvula Aórtica/cirugía , Tomografía Computarizada Multidetector/métodos , Factores de Riesgo , Estudios Retrospectivos , Diseño de Prótesis/estadística & datos numéricosRESUMEN
Introducción y objetivos: La incidencia de implante de marcapasos permanente (IMP) y nuevas alteraciones de la conducción (AC) con la ACURATE neo (Symetis S.A., Eclubens, Suiza) no se ha estudiado en detalle. Nuestro objetivo fue analizar sus predictores, evaluándose los factores relacionados con el paciente y con el dispositivo, tal como la profundidad del implante y la relación entre el dispositivo y el anillo (RDA). Métodos: De una población multicéntrica, se realizaron 2 análisis: nuevos IMP (n = 283), e IMP/nuevas AC en pacientes sin AC previas o marcapasos (n = 232). Resultados: En el 9,9% de los pacientes se necesitó nuevo IMP, que se asoció con un mayor índice de masa corporal, mayor proporción de bloqueo de rama derecha y bradicardia. Ni el implante de la prótesis ni la RDA difirieron entre pacientes con o sin IMP. En el análisis multivariante ni la RDA (OR = 1,010; IC95%, 0,967-1,055; p = 0,7), ni la profundidad del implante (OR = 0,972; IC95%, 0,743-1,272; p = 0,8) fueron predictores de IMP. Solo el índice de masa corporal, la bradicardia y el bloqueo de rama derecha persistieron como predictores independientes. El IMP/nueva aparición de AC ocurrió en el 22,8% de los pacientes y se asoció con un mayor EuroSCORE logístico. Ni la profundidad del implante ni la RDA eran diferentes en pacientes con o sin IMP/nueva aparición de AC (7,3 ± 1,9 frente a 7,1 ± 1,5 mm; p = 0,6 y 41,0 ± 7,9 frente a 42,2 ± 10,1%; p = 0,4). El único predictor de IMP/nuevo inicio de AC fue un mayor EuroSCORE logístico (OR = 1,039; IC95%, 1,008-1,071; p = 0,013). Conclusiones: La proporción de nuevos IMP y nueva aparición de AC eran inferiores con la ACURATE neo. Estos hechos están principalmente influenciados por las características de los pacientes y no por los factores dependientes del dispositivo
Introduction and objectives: The incidence of permanent pacemaker implantation (PPI) and new conduction abnormalities (CA) with the ACURATE neo (Symetis S.A., Eclubens, Switzerland) has not been studied in detail. We aimed to analyze their predictors, evaluating patient- and device-related factors, including implantation depth and device-to-annulus ratio (DAR). Methods: Two analyses of a multicenter population were performed: new PPI in pacemaker-naive patients (n = 283), and PPI/new-CA in patients without prior CA or pacemaker (n = 232). Results: A new PPI was required in 9.9% of patients, who had a higher body mass index, higher rate of right bundle branch block and bradycardia. Neither implantation depth nor DAR differed in patients with PPI compared with those without. In the multivariable analysis neither DAR (OR, 1.010; 95%CI, 0.967-1.055; P = .7) nor implantation depth (OR, 0.972; 95%CI, 0.743-1.272; P = .8) predicted PPI. Only high body mass index, bradycardia and right bundle branch block persisted as independent predictors. PPI/new-onset CA occurred in 22.8% of patients and was associated with a higher logistic EuroSCORE. Neither implantation depth nor DAR differed in patients with PPI/new-CA vs those without (7.3 ± 1.9 vs 7.1 ± 1.5 mm; P = .6 and 41.0 ± 7.9 vs 42.2 ± 10.1%; P = .4). The only predictor of PPI/new-CA was a higher logistic EuroSCORE (OR, 1.039; 95%CI, [1.008-1.071]; P = .013). Conclusions: New PPI and new-onset CA rates were low with the ACURATE neo. These were mainly influenced by patient characteristics and not by device-depending factors
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Humanos , Masculino , Femenino , Anciano , Anciano de 80 o más Años , Marcapaso Artificial/estadística & datos numéricos , Trastorno del Sistema de Conducción Cardíaco/epidemiología , Estenosis de la Válvula Aórtica/cirugía , Reemplazo de la Válvula Aórtica Transcatéter/métodos , Complicaciones Posoperatorias/epidemiología , Stents Metálicos Autoexpandibles/estadística & datos numéricos , Ajuste de Riesgo/métodosRESUMEN
Introducción y objetivos: El rendimiento de las puntuaciones de riesgo tradicionales para predecir el riesgo tras el implante percutáneo válvula aórtica (TAVI) no es adecuado. Las altas concentraciones plasmáticas de antígeno carbohidrato 125 (CA125) se han asociado a un aumento del riesgo de eventos adversos tras TAVI. En este trabajo se evalúa el valor pronóstico adicional del CA125 sobre la puntuación EuroSCORE para la predicción de riesgo a largo plazo. Métodos y resultados: Durante una mediana de seguimiento de 59 semanas, murieron 115 de 422 pacientes (27%) después de la TAVI. La mortalidad fue mayor entre aquellos con CA125 elevado (> 30 U/ml) y EuroSCORE ≥ mediana (el 47 frente al 20%; p < 0,001; y el 38 frente al 16%; p < 0,001 respectivamente). En el análisis multivariable, el CA125 (> 30 U/ml) seguía asociado con la mortalidad (hazard ratio [HR] = 2,16; intervalo de confianza del 95% [IC95%], 1,48-3,15; p < 0,001), mejoró la capacidad discriminativa del modelo (estadístico C = 0,736 frente a C = 0,731), el índice neto de reclasificación (51%; IC95%, 33-73) y el índice de mejora de la reclasificación (3,5%; IC95%, 0,5-8,4). La combinación de CA125 y EuroSCORE permitió la creación de una variable de 4 categorias (+, elevado, -, no elevado; C1, CA125- EuroSCORE-; C2, CA125+ EuroSCORE-; C3, CA125- EuroSCORE+, y C4, CA125+ EuroSCORE+). Los pacientes pertenecientes a C1 presentaron la menor mortalidad (14%, 26/181); C2 y C3, intermedia (27% [8/30] y 28% [37/131] respectivamente). Los pertenecientes a C4 presentaron la mayor mortalidad (55% [44/80]; p para la tendencia < 0,001). Conclusiones: El CA125 ofrece información pronóstica adicional a la proporcionada por la puntuación EuroSCORE. La elevación de ambos indicadores se asoció a peor pronóstico (AU)
Introduction and objectives: Conventional risk scores have not been accurate in predicting peri- and postprocedural risk of patients undergoing transcatheter aortic valve implantation (TAVI). Elevated levels of the tumor marker carbohydrate antigen 125 (CA125) have been linked to adverse outcomes after TAVI. We studied the additional value of CA125 to that of the EuroSCORE in predicting long-term mortality after TAVI. Methods and results: During a median follow-up of 59 weeks, 115 of 422 patients (27%) died after TAVI. Mortality was higher with elevated CA125 (> 30 U/mL) and EuroSCORE (> median) (47% vs 20%, P < .001 and 38% vs 16%, P < .001, respectively). In the multivariable analysis, CA125 (> 30 U/mL) remained an independent predictor of mortality (hazard ratio [HR], 2.16; 95% confidence interval [95%CI], 1.48-3.15; P < .001) and improved the predictive capability of the model (C-statistic: 0.736 vs 0.731) and the net reclassification index (51% 95%CI, 33-73) with an integrated discriminative improvement of 3.5% (95%CI, 0.5-8.4). A new variable (CA125-EuroSCORE) was created, with the combinations of the 2 possible binary states of these variables (+, elevated, -, not elevated; C1: CA125- EuroSCORE-; C2: CA125+ EuroSCORE-; C3: CA125- EuroSCORE+; C4: CA125+ EuroSCORE+). Patients in C1 exhibited the lowest cumulative mortality rate (14% [26 of 181]). Mortality was intermediate for C2 (CA125 > 30 U/mL and EuroSCORE ≤ median) and C3 (CA125 ≤ 30 U/mL and EuroSCORE > median): 27% (8 of 30) and 28% (37 of 131), respectively. Patients in C4 (CA125 > 30 U/mL and EuroSCORE > median) exhibited the highest mortality (55% [44 of 80], P-value for trend < .001). Conclusions: CA125 offers additional prognostic information beyond that obtained by the EuroSCORE. Elevation of both markers was associated with a poor prognosis (AU)
Asunto(s)
Humanos , Estenosis de la Válvula Aórtica/cirugía , Reemplazo de la Válvula Aórtica Transcatéter/métodos , Factores de Riesgo , Índice de Severidad de la Enfermedad , Antígeno Ca-125/análisisRESUMEN
Introducción y objetivos: El implante percutáneo de válvula aórtica se utiliza de manera creciente en pacientes con estenosis aórtica. Los trastornos de la conducción intraventricular y los implantes de marcapasos permanente tras la intervención siguen siendo motivo de gran preocupación. Recientemente, la válvula protésica Edwards SAPIEN XT ha sido reemplazada por la SAPIEN 3. El objetivo de este estudio es determinar la incidencia de trastornos de la conducción intraventricular de nueva aparición y la necesidad de implantes de marcapasos permanente comparando los dos dispositivos. Métodos: Se analizó a los últimos 103 pacientes consecutivos a los que se realizó implante percutáneo de válvula aórtica SAPIEN XT antes de que se utilizara la válvula SAPIEN 3 y a los 105 pacientes consecutivos a los que se implantó la válvula SAPIEN 3. Con objeto de analizar los implantes de marcapasos permanentes y los trastornos de la conducción intraventricular de nueva aparición, se excluyó del estudio a los pacientes en los que se daban estas características en situación basal. Se registraron electrocardiogramas en situación basal, después de la intervención y antes del alta. Resultados: El uso del dispositivo SAPIEN 3 se asoció a un porcentaje superior de éxitos de implante del dispositivo (el 100 frente al 92%; p = 0,005) y un porcentaje inferior de fuga paravalvular (0 frente al 7%; p < 0,001). La incidencia de implantes de marcapasos permanente fue del 12,6% (23 de 183), sin que se apreciaran diferencias entre los dos grupos (SAPIEN 3, el 12,5% [12 de 96]; SAPIEN XT, el 12,6% [11 de 87]; p = 0,99). El uso del dispositivo SAPIEN 3 se asoció a mayor frecuencia de trastornos de la conducción intraventricular de nueva aparición (el 49 frente al 27%; p = 0,007) como consecuencia de la mayor frecuencia de bloqueos fasciculares (el 17 frente al 5%; p = 0,021). No hubo diferencia estadísticamente significativa por lo que respecta a los bloqueos de rama izquierda transitorios frente a persistentes (el 29% [20 de 69] frente al 19% [12 de 64]; p = 0,168) al comparar el SAPIEN 3 con el SAPIEN XT (el 28% [19 de 69] frente al 17% [11 de 64]; p = 0,154). Conclusiones: Se observó una tendencia a mayor frecuencia de trastornos de la conducción intraventricular de nueva aparición con SAPIEN 3 que con SAPIEN XT, si bien esto no conllevó mayor frecuencia de implante de marcapasos permanentes (AU)
Introduction and objectives: Transcatheter aortic valve implantation is increasingly used in patients with aortic stenosis. Post-procedural intraventricular conduction abnormalities and permanent pacemaker implantations remain a serious concern. Recently, the Edwards SAPIEN 3 prosthesis has replaced the SAPIEN XT. We sought to determine the incidences of new-onset intraventricular conduction abnormalities and permanent pacemaker implantations by comparing the 2 devices. Methods: We analyzed the last consecutive 103 patients undergoing transcatheter aortic valve implantation with SAPIEN XT before SAPIEN 3 was used in the next 105 patients. To analyze permanent pacemaker implantations and new-onset intraventricular conduction abnormalities, patients with these conditions at baseline were excluded. Electrocardiograms were recorded at baseline, after the procedure, and before discharge. Results: SAPIEN 3 was associated with higher device success (100% vs 92%; P = .005) and less paravalvular leakage (0% vs 7%; P < .001). The incidence of permanent pacemaker implantations was 12.6% (23 of 183) with no difference between the 2 groups (SAPIEN 3: 12.5% [12 of 96] vs SAPIEN XT: 12.6% [11 of 87]; P = .99). SAPIEN 3 was associated with a higher rate of new-onset intraventricular conduction abnormalities (49% vs 27%; P = .007) due to a higher rate of fascicular blocks (17% vs 5%; P = .021). There was no statistically significant difference in transient (29% [20 of 69] vs persistent 19% [12 of 64]; P = .168) left bundle branch blocks (28% [19 of 69] vs 17% [11 of 64]; P = .154) when SAPIEN 3 was compared with SAPIEN XT. Conclusions: We found a trend toward a higher rate of new-onset intraventricular conduction abnormalities with SAPIEN 3 compared with SAPIEN XT, although this did not result in a higher permanent pacemaker implantation rate (AU)
Asunto(s)
Humanos , Reemplazo de la Válvula Aórtica Transcatéter , Marcapaso Artificial , Arritmias Cardíacas/etiología , Complicaciones Posoperatorias , Sistema de Conducción Cardíaco/fisiopatología , Tomografía Computarizada por Rayos XRESUMEN
IMPORTANCE: Limited data exist on clinical characteristics and outcomes of patients who had infective endocarditis after undergoing transcatheter aortic valve replacement (TAVR). OBJECTIVE: To determine the associated factors, clinical characteristics, and outcomes of patients who had infective endocarditis after TAVR. DESIGN, SETTING, AND PARTICIPANTS: The Infectious Endocarditis after TAVR International Registry included patients with definite infective endocarditis after TAVR from 47 centers from Europe, North America, and South America between June 2005 and October 2015. EXPOSURE: Transcatheter aortic valve replacement for incidence of infective endocarditis and infective endocarditis for in-hospital mortality. MAIN OUTCOMES AND MEASURES: Infective endocarditis and in-hospital mortality after infective endocarditis. RESULTS: A total of 250 cases of infective endocarditis occurred in 20 006 patients after TAVR (incidence, 1.1% per person-year; 95% CI, 1.1%-1.4%; median age, 80 years; 64% men). Median time from TAVR to infective endocarditis was 5.3 months (interquartile range [IQR], 1.5-13.4 months). The characteristics associated with higher risk of progressing to infective endocarditis after TAVR was younger age (78.9 years vs 81.8 years; hazard ratio [HR], 0.97 per year; 95% CI, 0.94-0.99), male sex (62.0% vs 49.7%; HR, 1.69; 95% CI, 1.13-2.52), diabetes mellitus (41.7% vs 30.0%; HR, 1.52; 95% CI, 1.02-2.29), and moderate to severe aortic regurgitation (22.4% vs 14.7%; HR, 2.05; 95% CI, 1.28-3.28). Health care-associated infective endocarditis was present in 52.8% (95% CI, 46.6%-59.0%) of patients...