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1.
Eur J Cardiothorac Surg ; 65(5)2024 May 03.
Artículo en Inglés | MEDLINE | ID: mdl-38730543

RESUMEN

OBJECTIVES: The aim of this study was to describe trends and outcomes for patients undergoing surgical aortic valve replacement (SAVR) in the Netherlands. METHODS: The Netherlands Heart Registration database was used to report the number and outcomes of isolated, primary SAVR procedures performed from 2007 to 2018 in adult patients. RESULTS: A total of 17 142 procedures were included, of which 77.9% were performed using a biological prosthesis and 21.0% with a mechanical prosthesis. Median logistic EuroSCORE I decreased from 4.6 [interquartile range (IQR) 2.4-7.7] to 4.0 (IQR 2.6-6.0). The 120-day mortality decreased from 3.3% in 2007 to 0.7% in 2018. The median duration of follow-up was 76 months (IQR 53-111). Ten-year survival, when adjusted for age, EuroSCORE I and body surface area, was 72.4%, and adjusted 10-year freedom from reinvervention was 98.1%. Additional analysis for patients under the age of 60 showed no difference between patients treated with a biological or mechanical prosthesis in adjusted 10-year survival, 89.7% vs 91.9±%, respectively (P = 0.25), but a significant difference in adjusted 10-year freedom from reintervention, 90.0±% vs 95.9%, respectively (P < 0.01). CONCLUSIONS: Between 2007 and 2018, age and risk profile of patients undergoing SAVR decreased, especially for patients treated with a biological prosthesis. The 120-day mortality decreased over time. Patients undergoing SAVR nowadays have a risk of 120-day mortality of <1% and 10-year freedom from valve-related reintervention of >95%.


Asunto(s)
Válvula Aórtica , Implantación de Prótesis de Válvulas Cardíacas , Humanos , Masculino , Países Bajos/epidemiología , Femenino , Anciano , Válvula Aórtica/cirugía , Implantación de Prótesis de Válvulas Cardíacas/tendencias , Implantación de Prótesis de Válvulas Cardíacas/estadística & datos numéricos , Implantación de Prótesis de Válvulas Cardíacas/mortalidad , Implantación de Prótesis de Válvulas Cardíacas/métodos , Persona de Mediana Edad , Resultado del Tratamiento , Prótesis Valvulares Cardíacas/tendencias , Anciano de 80 o más Años , Sistema de Registros , Estenosis de la Válvula Aórtica/cirugía , Estenosis de la Válvula Aórtica/mortalidad , Factores de Riesgo
2.
J Am Heart Assoc ; 13(10): e033601, 2024 May 21.
Artículo en Inglés | MEDLINE | ID: mdl-38761069

RESUMEN

BACKGROUND: The aims of this study were to understand the incidence and outcomes of patients with cardiogenic shock (CS) due to severe aortic stenosis (AS), and the impact of conventional treatment strategies in this population. METHODS AND RESULTS: All patients admitted to the Cleveland Clinic cardiac intensive care unit between January 1, 2010 and December 31, 2021 with CS were retrospectively identified and categorized into those with CS in the setting of severe AS versus CS without AS. The impact of various treatment strategies on mortality was further assessed. We identified 2754 patients with CS during the study period, of whom 216 patients (8%) had CS in the setting of severe AS. Medical management was associated with the highest 30-day mortality when compared with either balloon aortic valve replacement or aortic valve replacement (surgical or transcatheter aortic valve replacement) (hazard ratio, 3.69 [95% CI, 2.04-6.66]; P<0.0001). Among patients who received transcatheter therapy, 30-day mortality was significantly higher in patients who received balloon aortic valvuloplasty versus transcatheter aortic valve replacement (26% versus 4%, P=0.02). Both surgical and transcatheter aortic valve replacement had considerably lower mortality than medical management and balloon aortic valvuloplasty at 30 days and 1 year (P<0.05 for both comparisons). CONCLUSIONS: CS due to severe AS is associated with high in-hospital and 30-day mortality, worse compared with those with CS without AS. In suitable patients, urgent surgical aortic valvuloplasty or transcatheter aortic valve replacement is associated with favorable short- and long-term outcomes. Although balloon aortic valvuloplasty may be used to temporize patients with CS in the setting of severe AS, mortality is ≈50% if not followed by definitive aortic valve replacement within 90 days.


Asunto(s)
Estenosis de la Válvula Aórtica , Índice de Severidad de la Enfermedad , Choque Cardiogénico , Reemplazo de la Válvula Aórtica Transcatéter , Humanos , Choque Cardiogénico/terapia , Choque Cardiogénico/etiología , Choque Cardiogénico/mortalidad , Estenosis de la Válvula Aórtica/complicaciones , Estenosis de la Válvula Aórtica/cirugía , Estenosis de la Válvula Aórtica/mortalidad , Masculino , Femenino , Estudios Retrospectivos , Anciano , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Reemplazo de la Válvula Aórtica Transcatéter/mortalidad , Anciano de 80 o más Años , Valvuloplastia con Balón/mortalidad , Valvuloplastia con Balón/efectos adversos , Resultado del Tratamiento , Implantación de Prótesis de Válvulas Cardíacas/efectos adversos , Implantación de Prótesis de Válvulas Cardíacas/mortalidad , Factores de Riesgo , Factores de Tiempo , Incidencia
3.
Laeknabladid ; 110(5): 247-253, 2024 May.
Artículo en Islandés | MEDLINE | ID: mdl-38713559

RESUMEN

INTRODUCTION: One of the most serious complications of surgical aortic valve replacement (SAVR) is stroke that can result in increased rates of complications, morbidity and mortality postoperatively. The aim of this study was to investigate incidence, risk factors and short-term outcome in a well defined cohort of SAVR-patients. MATERIALS AND METHOD: A retrospective study on 740 consecutive aortic stenosis patients who underwent SAVR in Iceland 2002-2019. Patients with stroke were compared with non-stroke patients; including preoperative risk factors of cardiovascular disease, echocardiogram-results, rate of early postoperative complications other than stroke and 30 day mortality. RESULTS: Mean age was 71 yrs (34% females) with 57% of the patients receiving stented bioprosthesis, 31% a stentless Freestyle®-valve and 12% a mechanical valve. Mean EuroSCORE-II was 3.6, with a maximum preop-gradient of 70 mmHg and an estimated valvular area of 0.73 cm2. Thirteen (1.8%) patients were diagnosed with stroke where hemiplegia (n=9), loss of consciousness (n=3) and/or aphasia (n=4) were the most common presenting symptoms. In 70% of cases the neurological symptoms resolved or disappeared in the first weeks and months after surgery. Only one patient out of 13 died within 30-days (7.7%). Stroke-patients had significantly lower BMI than non-stroke patients, but other risk factors of cardiovascular diseases, intraoperative factors or the rate of other severe postoperative complications than stroke were similar between groups. Total length of stay was 14 days vs. 10 days median, including 2 vs. 1 days in the ICU, in the stroke and non-stroke-groups, respectively. CONCLUSIONS: The rate of stroke after SAVR was low (1.8%) and in line with other similar studies. Although a severe complication, most patients with perioperative stroke survived 30 days postoperatively and in majority of cases neurological symptoms recovered.


Asunto(s)
Estenosis de la Válvula Aórtica , Válvula Aórtica , Implantación de Prótesis de Válvulas Cardíacas , Prótesis Valvulares Cardíacas , Accidente Cerebrovascular , Humanos , Femenino , Estenosis de la Válvula Aórtica/cirugía , Estenosis de la Válvula Aórtica/mortalidad , Estenosis de la Válvula Aórtica/diagnóstico por imagen , Masculino , Anciano , Factores de Riesgo , Estudios Retrospectivos , Islandia/epidemiología , Implantación de Prótesis de Válvulas Cardíacas/efectos adversos , Implantación de Prótesis de Válvulas Cardíacas/mortalidad , Implantación de Prótesis de Válvulas Cardíacas/instrumentación , Accidente Cerebrovascular/epidemiología , Accidente Cerebrovascular/mortalidad , Accidente Cerebrovascular/etiología , Incidencia , Factores de Tiempo , Resultado del Tratamiento , Válvula Aórtica/cirugía , Válvula Aórtica/diagnóstico por imagen , Medición de Riesgo , Anciano de 80 o más Años , Persona de Mediana Edad
4.
Sci Rep ; 14(1): 10902, 2024 05 13.
Artículo en Inglés | MEDLINE | ID: mdl-38740898

RESUMEN

Calcification of the aortic valve (CAVDS) is a major cause of aortic stenosis (AS) leading to loss of valve function which requires the substitution by surgical aortic valve replacement (SAVR) or transcatheter aortic valve intervention (TAVI). These procedures are associated with high post-intervention mortality, then the corresponding risk assessment is relevant from a clinical standpoint. This study compares the traditional Cox Proportional Hazard (CPH) against Machine Learning (ML) based methods, such as Deep Learning Survival (DeepSurv) and Random Survival Forest (RSF), to identify variables able to estimate the risk of death one year after the intervention, in patients undergoing either to SAVR or TAVI. We found that with all three approaches the combination of six variables, named albumin, age, BMI, glucose, hypertension, and clonal hemopoiesis of indeterminate potential (CHIP), allows for predicting mortality with a c-index of approximately 80 % . Importantly, we found that the ML models have a better prediction capability, making them as effective for statistical analysis in medicine as most state-of-the-art approaches, with the additional advantage that they may expose non-linear relationships. This study aims to improve the early identification of patients at higher risk of death, who could then benefit from a more appropriate therapeutic intervention.


Asunto(s)
Estenosis de la Válvula Aórtica , Válvula Aórtica , Calcinosis , Aprendizaje Profundo , Humanos , Válvula Aórtica/cirugía , Válvula Aórtica/patología , Calcinosis/cirugía , Calcinosis/mortalidad , Femenino , Masculino , Anciano , Estenosis de la Válvula Aórtica/cirugía , Estenosis de la Válvula Aórtica/mortalidad , Reemplazo de la Válvula Aórtica Transcatéter/mortalidad , Anciano de 80 o más Años , Análisis de Supervivencia , Factores de Riesgo , Modelos de Riesgos Proporcionales , Medición de Riesgo/métodos , Implantación de Prótesis de Válvulas Cardíacas/mortalidad , Implantación de Prótesis de Válvulas Cardíacas/métodos , Persona de Mediana Edad
5.
Catheter Cardiovasc Interv ; 103(6): 1023-1034, 2024 May.
Artículo en Inglés | MEDLINE | ID: mdl-38639143

RESUMEN

BACKGROUND: The clinical efficacy and safety of alcohol septal ablation (ASA) for obstructive hypertrophic cardiomyopathy (HCM) have been well-established; however, less is known about outcomes in patients undergoing preemptive ASA before transcatheter mitral valve replacement (TMVR). AIMS: The goal of this study is to characterize the procedural characteristics and examine the clinical outcomes of ASA in both HCM and pre-TMVR. METHODS: This retrospective study compared procedural characteristics and outcomes in patient who underwent ASA for HCM and TMVR. RESULTS: In total, 137 patients were included, 86 in the HCM group and 51 in the TMVR group. The intraventricular septal thickness (mean 1.8 vs. 1.2 cm; p < 0.0001) and the pre-ASA LVOT gradient (73.6 vs. 33.8 mmHg; p ≤ 0.001) were higher in the HCM group vs the TMVR group. The mean volume of ethanol injected was higher (mean 2.4 vs. 1.7 cc; p < 0.0001). The average neo-left ventricular outflow tract area increased significantly after ASA in the patients undergoing TMVR (99.2 ± 83.37 mm2 vs. 196.5 ± 114.55 mm2; p = <0.0001). The HCM group had a greater reduction in the LVOT gradient after ASA vs the TMVR group (49.3 vs. 18 mmHg; p = 0.0040). The primary composite endpoint was higher in the TMVR group versus the HCM group (50.9% vs. 25.6%; p = 0.0404) and had a higher incidence of new permanent pacemaker (PPM) (25.5% vs. 18.6%; p = 0.3402). The TMVR group had a higher rate of all-cause mortality (9.8% vs. 1.2%; p = 0.0268). CONCLUSIONS: Preemptive ASA before TMVR was performed in patients with higher degree of clinical comorbidities, and correspondingly is associated with worse short-term clinical outcomes in comparison to ASA for HCM patients. ASA before TMVR enabled percutaneous mitral interventions in a small but significant minority of patients that would have otherwise been excluded. The degree of LVOT and neoLVOT area increase is significant and predictable.


Asunto(s)
Técnicas de Ablación , Cateterismo Cardíaco , Cardiomiopatía Hipertrófica , Etanol , Implantación de Prótesis de Válvulas Cardíacas , Válvula Mitral , Humanos , Estudios Retrospectivos , Masculino , Etanol/administración & dosificación , Etanol/efectos adversos , Cardiomiopatía Hipertrófica/diagnóstico por imagen , Cardiomiopatía Hipertrófica/mortalidad , Cardiomiopatía Hipertrófica/terapia , Cardiomiopatía Hipertrófica/cirugía , Cardiomiopatía Hipertrófica/fisiopatología , Femenino , Resultado del Tratamiento , Técnicas de Ablación/efectos adversos , Técnicas de Ablación/mortalidad , Anciano , Cateterismo Cardíaco/efectos adversos , Cateterismo Cardíaco/mortalidad , Cateterismo Cardíaco/instrumentación , Persona de Mediana Edad , Factores de Riesgo , Implantación de Prótesis de Válvulas Cardíacas/efectos adversos , Implantación de Prótesis de Válvulas Cardíacas/instrumentación , Implantación de Prótesis de Válvulas Cardíacas/mortalidad , Factores de Tiempo , Válvula Mitral/diagnóstico por imagen , Válvula Mitral/fisiopatología , Válvula Mitral/cirugía , Recuperación de la Función , Anciano de 80 o más Años , Tabiques Cardíacos/diagnóstico por imagen , Tabiques Cardíacos/cirugía , Insuficiencia de la Válvula Mitral/diagnóstico por imagen , Insuficiencia de la Válvula Mitral/fisiopatología , Insuficiencia de la Válvula Mitral/cirugía , Insuficiencia de la Válvula Mitral/mortalidad
6.
JACC Cardiovasc Interv ; 17(8): 1073-1075, 2024 Apr 22.
Artículo en Inglés | MEDLINE | ID: mdl-38658125
8.
N Engl J Med ; 390(17): 1572-1583, 2024 May 02.
Artículo en Inglés | MEDLINE | ID: mdl-38588025

RESUMEN

BACKGROUND: Among low-risk patients with severe, symptomatic aortic stenosis who are eligible for both transcatheter aortic-valve implantation (TAVI) and surgical aortic-valve replacement (SAVR), data are lacking on the appropriate treatment strategy in routine clinical practice. METHODS: In this randomized noninferiority trial conducted at 38 sites in Germany, we assigned patients with severe aortic stenosis who were at low or intermediate surgical risk to undergo either TAVI or SAVR. Percutaneous- and surgical-valve prostheses were selected according to operator discretion. The primary outcome was a composite of death from any cause or fatal or nonfatal stroke at 1 year. RESULTS: A total of 1414 patients underwent randomization (701 to the TAVI group and 713 to the SAVR group). The mean (±SD) age of the patients was 74±4 years; 57% were men, and the median Society of Thoracic Surgeons risk score was 1.8% (low surgical risk). The Kaplan-Meier estimate of the primary outcome at 1 year was 5.4% in the TAVI group and 10.0% in the SAVR group (hazard ratio for death or stroke, 0.53; 95% confidence interval [CI], 0.35 to 0.79; P<0.001 for noninferiority). The incidence of death from any cause was 2.6% in the TAVI group and 6.2% in the SAVR group (hazard ratio, 0.43; 95% CI, 0.24 to 0.73); the incidence of stroke was 2.9% and 4.7%, respectively (hazard ratio, 0.61; 95% CI, 0.35 to 1.06). Procedural complications occurred in 1.5% and 1.0% of patients in the TAVI and SAVR groups, respectively. CONCLUSIONS: Among patients with severe aortic stenosis at low or intermediate surgical risk, TAVI was noninferior to SAVR with respect to death from any cause or stroke at 1 year. (Funded by the German Center for Cardiovascular Research and the German Heart Foundation; DEDICATE-DZHK6 ClinicalTrials.gov number, NCT03112980.).


Asunto(s)
Estenosis de la Válvula Aórtica , Reemplazo de la Válvula Aórtica Transcatéter , Anciano , Femenino , Humanos , Masculino , Válvula Aórtica/cirugía , Estenosis de la Válvula Aórtica/cirugía , Estenosis de la Válvula Aórtica/mortalidad , Prótesis Valvulares Cardíacas , Implantación de Prótesis de Válvulas Cardíacas/efectos adversos , Implantación de Prótesis de Válvulas Cardíacas/métodos , Implantación de Prótesis de Válvulas Cardíacas/mortalidad , Estimación de Kaplan-Meier , Accidente Cerebrovascular/epidemiología , Accidente Cerebrovascular/etiología , Accidente Cerebrovascular/mortalidad , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Reemplazo de la Válvula Aórtica Transcatéter/instrumentación , Reemplazo de la Válvula Aórtica Transcatéter/métodos , Reemplazo de la Válvula Aórtica Transcatéter/mortalidad , Factores de Riesgo , Alemania
10.
J Cardiovasc Surg (Torino) ; 65(2): 161-168, 2024 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-38332715

RESUMEN

BACKGROUND: Based on worldwide registries, approximately 50% of patients who underwent aortic valve replacement (AVR) via surgical aortic valve replacement are females. Although AVR procedures have improved greatly in recent years, differences in outcome including mortality between sexes remain. We aimed to investigate the trends in SAVR outcomes in females versus males. METHODS: Using the 2011-2017 National Inpatient Sample (NIS) database, we identified hospitalizations for patients with diagnosis of aortic stenosis during which SAVR was performed. Patients' sociodemographic and clinical characteristics, procedure complications, and mortality were analyzed. Piecewise regression analyses were performed to assess temporal trends in SAVR utilization in females versus males. Multivariable analyses were performed to identify predictors of in-hospital mortality. RESULTS: A total of 392,087 hospitalizations for SAVR across the USA were analyzed. Utilization of SAVR in both sex patients decreased significantly during the years 2011-2017. Males compared to females had significantly higher rates of hyperlipidemia, chronic renal disease, peripheral artery disease, coronary artery disease and tended to be smokers. Differences in mortality rates among sexes were observed for SAVR procedures. Women had higher in-hospital mortality with 3.7% compared to men with 2.5% (OR 1.38 [95% CI 1.33-1.43, P<0.001]). In a multivariable regression model analysis adjusted for potential confounders, women had higher mortality risk with odd ratio (OR 1.38 [95% CI 1.33-1.43], P<0.001). Women had significantly higher rates of vascular complications (5.1% compared to men with 4.6%, P=0.002). CONCLUSIONS: Utilization of SAVR showed a downward trend during the study period. Higher in-hospital mortality was recorded in females compared to males.


Asunto(s)
Estenosis de la Válvula Aórtica , Válvula Aórtica , Bases de Datos Factuales , Implantación de Prótesis de Válvulas Cardíacas , Mortalidad Hospitalaria , Humanos , Femenino , Masculino , Anciano , Mortalidad Hospitalaria/tendencias , Estados Unidos/epidemiología , Factores Sexuales , Factores de Riesgo , Estenosis de la Válvula Aórtica/cirugía , Estenosis de la Válvula Aórtica/mortalidad , Resultado del Tratamiento , Implantación de Prótesis de Válvulas Cardíacas/mortalidad , Implantación de Prótesis de Válvulas Cardíacas/efectos adversos , Implantación de Prótesis de Válvulas Cardíacas/tendencias , Válvula Aórtica/cirugía , Factores de Tiempo , Persona de Mediana Edad , Anciano de 80 o más Años , Complicaciones Posoperatorias/mortalidad , Complicaciones Posoperatorias/epidemiología , Estudios Retrospectivos , Pacientes Internos , Disparidades en el Estado de Salud , Medición de Riesgo , Disparidades en Atención de Salud/tendencias , Comorbilidad
11.
Int J Surg ; 110(5): 3039-3049, 2024 May 01.
Artículo en Inglés | MEDLINE | ID: mdl-38348836

RESUMEN

INTRODUCTION: This study aims to investigate the effect of concomitant tricuspid valve surgery (TVS) during left ventricular assist device (LVAD) implantation due to the controversy over the clinical outcomes of concomitant TVS in patients undergoing LVAD. METHODS: A systematic literature search was performed in PubMed and EMbase from the inception to 1 August 2023. Studies comparing outcomes in adult patients undergoing concomitant TVS during LVAD implantation (TVS group) and those who did not (no-TVS group) were included. The primary outcomes were right heart failure (RHF), right ventricular assist device (RVAD) implantation, and early mortality. All meta-analyses were performed using random-effects models, and a two-tailed P <0.05 was considered significant. RESULTS: Twenty-one studies were included, and 16 of them were involved in the meta-analysis, with 660 patients in the TVS group and 1291 in the no-TVS group. Patients in the TVS group suffered from increased risks of RHF [risk ratios (RR)=1.31, 95% CI: 1.01-1.70, P =0.04; I2 =38%, pH =0.13), RVAD implantation (RR=1.56, 95% CI: 1.16-2.11, P =0.003; I2 =0%, pH =0.74), and early mortality (RR=1.61, 95% CI: 1.07-2.42, P =0.02; I2 =0%, pH =0.75). Besides, the increased risk of RHF holds true in patients with moderate to severe tricuspid regurgitation (RR=1.36, 95% CI: 1.04-1.78, P =0.02). TVS was associated with a prolonged cardiopulmonary bypass time. No significant differences in acute kidney injury, reoperation requirement, hospital length of stay, or ICU stay were observed. CONCLUSIONS: Concomitant TVS failed to show benefits in patients undergoing LVAD, and it was associated with increased risks of RHF, RVAD implantation, and early mortality.


Asunto(s)
Insuficiencia Cardíaca , Corazón Auxiliar , Válvula Tricúspide , Humanos , Válvula Tricúspide/cirugía , Insuficiencia Cardíaca/cirugía , Insuficiencia Cardíaca/mortalidad , Insuficiencia de la Válvula Tricúspide/cirugía , Implantación de Prótesis de Válvulas Cardíacas/efectos adversos , Implantación de Prótesis de Válvulas Cardíacas/mortalidad , Implantación de Prótesis de Válvulas Cardíacas/instrumentación
12.
Catheter Cardiovasc Interv ; 103(6): 1050-1061, 2024 May.
Artículo en Inglés | MEDLINE | ID: mdl-38363035

RESUMEN

INTRODUCTION: Right-side infective endocarditis (RSIE) is caused by microorganisms and develops into intracardiac and extracardiac complications with high in-hospital and 1-year mortality. Treatments involve antibiotic and surgical intervention. However, those presenting with extremes e.g. heart failure, or septic shock who are not ideal candidates for conventional medical therapy might benefit from minimally invasive procedures. OBJECTIVE: This review summarizes existing observational studies that reported minimally invasive procedures to debulk vegetation due to infective endocarditis either on valve or cardiac implantable electronic devices. METHODS: A targeted literature review was conducted to identify studies published in PubMed/MEDLINE, EMBASE, and Cochrane Central Database from January 1, 2015 to June 5, 2023. The efficacy and/or effectiveness of minimally invasive procedural interventions to debulk vegetation due to RSIE were summarized following PRISMA guidelines. RESULTS: A total of 11 studies with 208 RSIE patients were included. There were 9 studies that assessed the effectiveness of the AngioVac system and 2 assessed the Penumbra system. Overall procedure success rate was 87.9%. Among 8 studies that reported index hospitalization, 4 studies reported no death, while the other 4 studies reported 10 deaths. CONCLUSIONS: This study demonstrates that multiple systems can provide minimally invasive procedure options for patients with RSIE with high procedural success. However, there are mixed results regarding complications and mortality rates. Further large cohort studies or randomized clinical trials are warranted to assess and/or compare the efficacy and safety of these systems.


Asunto(s)
Endocarditis Bacteriana , Humanos , Cateterismo Cardíaco/efectos adversos , Cateterismo Cardíaco/instrumentación , Cateterismo Cardíaco/mortalidad , Endocarditis/cirugía , Endocarditis/mortalidad , Endocarditis Bacteriana/diagnóstico , Endocarditis Bacteriana/mortalidad , Endocarditis Bacteriana/cirugía , Implantación de Prótesis de Válvulas Cardíacas/efectos adversos , Implantación de Prótesis de Válvulas Cardíacas/instrumentación , Implantación de Prótesis de Válvulas Cardíacas/mortalidad , Estudios Observacionales como Asunto , Infecciones Relacionadas con Prótesis/mortalidad , Infecciones Relacionadas con Prótesis/cirugía , Factores de Riesgo , Resultado del Tratamiento
13.
JAMA ; 327(19): 1875-1887, 2022 05 17.
Artículo en Inglés | MEDLINE | ID: mdl-35579641

RESUMEN

Importance: Transcatheter aortic valve implantation (TAVI) is a less invasive alternative to surgical aortic valve replacement and is the treatment of choice for patients at high operative risk. The role of TAVI in patients at lower risk is unclear. Objective: To determine whether TAVI is noninferior to surgery in patients at moderately increased operative risk. Design, Setting, and Participants: In this randomized clinical trial conducted at 34 UK centers, 913 patients aged 70 years or older with severe, symptomatic aortic stenosis and moderately increased operative risk due to age or comorbidity were enrolled between April 2014 and April 2018 and followed up through April 2019. Interventions: TAVI using any valve with a CE mark (indicating conformity of the valve with all legal and safety requirements for sale throughout the European Economic Area) and any access route (n = 458) or surgical aortic valve replacement (surgery; n = 455). Main Outcomes and Measures: The primary outcome was all-cause mortality at 1 year. The primary hypothesis was that TAVI was noninferior to surgery, with a noninferiority margin of 5% for the upper limit of the 1-sided 97.5% CI for the absolute between-group difference in mortality. There were 36 secondary outcomes (30 reported herein), including duration of hospital stay, major bleeding events, vascular complications, conduction disturbance requiring pacemaker implantation, and aortic regurgitation. Results: Among 913 patients randomized (median age, 81 years [IQR, 78 to 84 years]; 424 [46%] were female; median Society of Thoracic Surgeons mortality risk score, 2.6% [IQR, 2.0% to 3.4%]), 912 (99.9%) completed follow-up and were included in the noninferiority analysis. At 1 year, there were 21 deaths (4.6%) in the TAVI group and 30 deaths (6.6%) in the surgery group, with an adjusted absolute risk difference of -2.0% (1-sided 97.5% CI, -∞ to 1.2%; P < .001 for noninferiority). Of 30 prespecified secondary outcomes reported herein, 24 showed no significant difference at 1 year. TAVI was associated with significantly shorter postprocedural hospitalization (median of 3 days [IQR, 2 to 5 days] vs 8 days [IQR, 6 to 13 days] in the surgery group). At 1 year, there were significantly fewer major bleeding events after TAVI compared with surgery (7.2% vs 20.2%, respectively; adjusted hazard ratio [HR], 0.33 [95% CI, 0.24 to 0.45]) but significantly more vascular complications (10.3% vs 2.4%; adjusted HR, 4.42 [95% CI, 2.54 to 7.71]), conduction disturbances requiring pacemaker implantation (14.2% vs 7.3%; adjusted HR, 2.05 [95% CI, 1.43 to 2.94]), and mild (38.3% vs 11.7%) or moderate (2.3% vs 0.6%) aortic regurgitation (adjusted odds ratio for mild, moderate, or severe [no instance of severe reported] aortic regurgitation combined vs none, 4.89 [95% CI, 3.08 to 7.75]). Conclusions and Relevance: Among patients aged 70 years or older with severe, symptomatic aortic stenosis and moderately increased operative risk, TAVI was noninferior to surgery with respect to all-cause mortality at 1 year. Trial Registration: isrctn.com Identifier: ISRCTN57819173.


Asunto(s)
Estenosis de la Válvula Aórtica , Reemplazo de la Válvula Aórtica Transcatéter , Anciano , Anciano de 80 o más Años , Válvula Aórtica/cirugía , Insuficiencia de la Válvula Aórtica/etiología , Estenosis de la Válvula Aórtica/mortalidad , Estenosis de la Válvula Aórtica/cirugía , Femenino , Prótesis Valvulares Cardíacas , Implantación de Prótesis de Válvulas Cardíacas/efectos adversos , Implantación de Prótesis de Válvulas Cardíacas/métodos , Implantación de Prótesis de Válvulas Cardíacas/mortalidad , Humanos , Masculino , Factores de Riesgo , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Reemplazo de la Válvula Aórtica Transcatéter/mortalidad , Resultado del Tratamiento
15.
J Am Coll Cardiol ; 79(1): 18-32, 2022 01 04.
Artículo en Inglés | MEDLINE | ID: mdl-34991785

RESUMEN

BACKGROUND: Transcatheter pulmonary valve (TPV) replacement (TPVR) has become the standard therapy for postoperative pulmonary outflow tract dysfunction in patients with a prosthetic conduit/valve, but there is limited information about risk factors for death or reintervention after this procedure. OBJECTIVES: This study sought to evaluate mid- and long-term outcomes after TPVR in a large multicenter cohort. METHODS: International registry focused on time-related outcomes after TPVR. RESULTS: Investigators submitted data for 2,476 patients who underwent TPVR and were followed up for 8,475 patient-years. A total of 95 patients died after TPVR, most commonly from heart failure (n = 24). The cumulative incidence of death was 8.9% (95% CI: 6.9%-11.5%) 8 years after TPVR. On multivariable analysis, age at TPVR (HR: 1.04 per year; 95% CI: 1.03-1.06 per year; P < 0.001), a prosthetic valve in other positions (HR: 2.1; 95% CI: 1.2-3.7; P = 0.014), and an existing transvenous pacemaker/implantable cardioverter-defibrillator (HR: 2.1; 95% CI: 1.3-3.4; P = 0.004) were associated with death. A total of 258 patients underwent TPV reintervention. At 8 years, the cumulative incidence of any TPV reintervention was 25.1% (95% CI: 21.8%-28.5%) and of surgical TPV reintervention was 14.4% (95% CI: 11.9%-17.2%). Risk factors for surgical reintervention included age (0.95 per year [95% CI: 0.93-0.97 per year]; P < 0.001), prior endocarditis (2.5 [95% CI: 1.4-4.3]; P = 0.001), TPVR into a stented bioprosthetic valve (1.7 [95% CI: 1.2-2.5]; P = 0.007), and postimplant gradient (1.4 per 10 mm Hg [95% CI: 1.2-1.7 per 10 mm Hg]: P < 0.001). CONCLUSIONS: These findings support the conclusion that survival and freedom from reintervention or surgery after TPVR are generally comparable to outcomes of surgical conduit/valve replacement across a wide age range.


Asunto(s)
Implantación de Prótesis de Válvulas Cardíacas , Válvula Pulmonar/cirugía , Reoperación/estadística & datos numéricos , Adolescente , Adulto , Factores de Edad , Niño , Preescolar , Desfibriladores Implantables , Endocarditis/epidemiología , Femenino , Prótesis Valvulares Cardíacas , Implantación de Prótesis de Válvulas Cardíacas/mortalidad , Humanos , Lactante , Recién Nacido , Masculino , Persona de Mediana Edad , Marcapaso Artificial , Sistema de Registros , Adulto Joven
16.
J Thorac Cardiovasc Surg ; 163(2): 591-602.e1, 2022 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-32620398

RESUMEN

OBJECTIVE: For degenerative mitral disease, repair is superior to replacement; however, the best operative strategy for rheumatic mitral disease remains unclear. We evaluated the association between decision-making in choosing repair versus replacement and outcomes across 2 decades of rheumatic mitral surgery. METHODS: Patients undergoing isolated, first-time rheumatic mitral surgery were identified. Era 1 (1997-2008) and Era 2 (2009-2018) were distinguished by intraoperative assessment of anterior leaflet mobility/calcification (Era 2) in deciding between mitral repair versus replacement. Primary outcome was a composite of death, reoperation, and severe valve dysfunction. RESULTS: Among 180 patients, age was 59 ± 14 years, and ejection fraction was 58% ± 10%. A higher proportion in Era 1 (n = 56) compared with Era 2 (n = 124) had preoperative atrial fibrillation (68% vs 46%; P = .006); the groups were otherwise similar. Primary indication was mitral stenosis in 69% (124 out of 180; pure = 35, mixed = 89) and did not differ by era (P = .67). During Era 1, 70% (39 out of 56) underwent repair, compared with 33% (41 out of 124) during Era 2 (P < .001). Freedom from death, reoperation, or severe valve dysfunction at 5 years was higher in Era 2 (72% ± 9%) than Era 1 (54% ± 13%; P = .04). Five-year survival was higher in Era 2 than Era 1, but did not differ between repair versus replacement. Five-year cumulative incidence of reoperation with death as a competing risk did not differ by era, but was higher after repair than replacement. CONCLUSIONS: Careful assessment of anterior leaflet mobility/calcification to determine mitral repair or replacement was associated with improved outcomes. This decision-making strategy may alter the threshold for rheumatic mitral replacement in the current valve-in-valve era.


Asunto(s)
Implantación de Prótesis de Válvulas Cardíacas , Anuloplastia de la Válvula Mitral , Insuficiencia de la Válvula Mitral/cirugía , Estenosis de la Válvula Mitral/cirugía , Válvula Mitral/cirugía , Cardiopatía Reumática/cirugía , Adulto , Anciano , Anciano de 80 o más Años , Femenino , Implantación de Prótesis de Válvulas Cardíacas/efectos adversos , Implantación de Prótesis de Válvulas Cardíacas/mortalidad , Hemodinámica , Humanos , Masculino , Persona de Mediana Edad , Válvula Mitral/diagnóstico por imagen , Válvula Mitral/fisiopatología , Anuloplastia de la Válvula Mitral/efectos adversos , Anuloplastia de la Válvula Mitral/mortalidad , Insuficiencia de la Válvula Mitral/diagnóstico por imagen , Insuficiencia de la Válvula Mitral/mortalidad , Insuficiencia de la Válvula Mitral/fisiopatología , Estenosis de la Válvula Mitral/diagnóstico por imagen , Estenosis de la Válvula Mitral/mortalidad , Estenosis de la Válvula Mitral/fisiopatología , Complicaciones Posoperatorias/mortalidad , Complicaciones Posoperatorias/cirugía , Recuperación de la Función , Reoperación , Estudios Retrospectivos , Cardiopatía Reumática/diagnóstico por imagen , Cardiopatía Reumática/mortalidad , Cardiopatía Reumática/fisiopatología , Medición de Riesgo , Factores de Riesgo , Factores de Tiempo , Resultado del Tratamiento , Adulto Joven
17.
J Thorac Cardiovasc Surg ; 163(2): 607-622.e14, 2022 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-32713629

RESUMEN

BACKGROUND: Treatment of ischemic mitral regurgitation (IMR) is in evolution, as percutaneous procedures and complex surgical repair have been recently investigated in randomized clinical trials and matched studies. This study aims to review and compare the current treatment options for IMR. METHODS: A comprehensive literature search was conducted using electronic databases. The primary outcome was all-cause long-term mortality. The secondary outcomes were perioperative mortality, unplanned rehospitalization, reoperation, and composite end points as defined in the original articles. RESULTS: A total of 12 articles met the inclusion criteria and were included in the final meta-analysis. The MitraClip procedure did not confer a significant benefit in mortality and repeated hospitalization compared with medical therapy alone. In patients with moderate IMR, the adjunct of mitral procedure over coronary artery bypass graft is not associated with clinical improvements. When evaluating mitral valve (MV) replacement versus repair, hospital mortality was greater among patients undergoing replacement (odds ratio [OR], 1.91; P = .009), but both reoperation and readmission rates were lower (OR, 0.60, P = .05; and OR, 0.45, P < .02, respectively). Comparing restrictive annuloplasty alone with adjunctive subvalvular repair, subvalvular procedures resulted in fewer readmissions (OR, 0.50; P = .06) and adverse composite end points (P = .009). CONCLUSIONS: MitraClip procedure is not associated with improved outcomes compared with medical therapy. MV replacement is associated with increased early mortality but reduced reoperation rate and readmission rate compared with MV repair using annuloplasty in moderate-to-severe IMR. Despite no significant benefit in isolated outcomes comparing annular and adjunct subvalvular procedures, the adjunct of subvalvular procedures reduces the risk of major postoperative adverse events.


Asunto(s)
Fármacos Cardiovasculares/uso terapéutico , Implantación de Prótesis de Válvulas Cardíacas , Anuloplastia de la Válvula Mitral , Insuficiencia de la Válvula Mitral/terapia , Válvula Mitral/cirugía , Isquemia Miocárdica/complicaciones , Anciano , Anciano de 80 o más Años , Fármacos Cardiovasculares/efectos adversos , Femenino , Prótesis Valvulares Cardíacas , Implantación de Prótesis de Válvulas Cardíacas/efectos adversos , Implantación de Prótesis de Válvulas Cardíacas/instrumentación , Implantación de Prótesis de Válvulas Cardíacas/mortalidad , Mortalidad Hospitalaria , Humanos , Masculino , Persona de Mediana Edad , Válvula Mitral/fisiopatología , Anuloplastia de la Válvula Mitral/efectos adversos , Anuloplastia de la Válvula Mitral/instrumentación , Anuloplastia de la Válvula Mitral/mortalidad , Insuficiencia de la Válvula Mitral/etiología , Insuficiencia de la Válvula Mitral/mortalidad , Insuficiencia de la Válvula Mitral/fisiopatología , Isquemia Miocárdica/mortalidad , Isquemia Miocárdica/fisiopatología , Readmisión del Paciente , Complicaciones Posoperatorias/mortalidad , Complicaciones Posoperatorias/cirugía , Diseño de Prótesis , Recuperación de la Función , Reoperación , Medición de Riesgo , Factores de Riesgo , Factores de Tiempo , Resultado del Tratamiento
18.
J Thorac Cardiovasc Surg ; 163(3): 925-935.e5, 2022 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-32727681

RESUMEN

OBJECTIVE: This multi-institutional study compares the long-term outcome of elderly patients with severe aortic stenosis and an intermediate risk profile undergoing sutureless versus transcatheter aortic valve implantation. METHODS: From 2008 to 2015, 967 elderly patients (>75 years) with intermediate risk (Society of Thoracic Surgeons score 4%-8%) and isolated aortic stenosis were included in the study (sutureless valve = 481; transcatheter aortic valve implantation = 486). After propensity score matching, 2 matched groups of 291 patients were obtained. Transcatheter valves implanted in patients were the CoreValve (Medtronic, Minneapolis, Minn), Edwards SAPIEN-XT (Edwards Lifesciences, Irvine, Calif), and Acurate-TA (Symetis, Lausanne, Switzerland). Primary end points included all-cause death at 30 days and 5 years. Secondary end points included early and 5-year incidence of composite adverse events (major adverse cardiovascular events: all-cause death, stroke, pacemaker implant, myocardial infarction, paravalvular leak ≥II, and reoperation). RESULTS: After matching, there were no substantial differences between groups. The 30-day mortality was significantly lower in the sutureless valve group (sutureless valve = 1.7% vs transcatheter aortic valve implantation = 5.5%; P = .024) and the rate of permanent pacemaker implantation (sutureless valve = 5.5% vs transcatheter aortic valve implantation = 10.7%, P = .032). Stroke/transient ischemic attack cumulative incidence at 5 years was 1.4% in the sutureless valve group and 5.3% in the transcatheter aortic valve implantation group (P = .010). The incidence of perivalvular leak grade II or greater was 1.3% in the sutureless valve group and 9.8% in the transcatheter aortic valve implantation group (P < .001). At 60 months follow-up, the all-cause death rate was lower in the sutureless valve group than in the transcatheter aortic valve implantation group (sutureless valve = 16.1% ± 4.1% vs transcatheter aortic valve implantation = 28.9% ± 5.3%, P = .006), and the major adverse cardiovascular event rate was lower in the sutureless valve group (sutureless valve = 23.5% ± 4.1% vs transcatheter aortic valve implantation = 39.0% ± 5.6%, P = .002). Multivariable Cox regression identified transcatheter aortic valve implantation as an independent predictor for 5-year mortality and major adverse cardiovascular events (hazard ratio, 1.86; confidence interval, 1.09-3.18; P = .022) (hazard ratio, 1.73; confidence interval, 1.13-2.73; P = .010). CONCLUSIONS: Sutureless valves improved the outcomes of aortic stenosis in elderly patients with an intermediate risk profile when compared with transcatheter aortic valve implantation. The use of transcatheter aortic valve implantation in this subset population should be evaluated in further controlled randomized trials with sutureless valve use in a comparative cohort.


Asunto(s)
Estenosis de la Válvula Aórtica/cirugía , Válvula Aórtica/cirugía , Implantación de Prótesis de Válvulas Cardíacas/instrumentación , Prótesis Valvulares Cardíacas , Procedimientos Quirúrgicos sin Sutura/instrumentación , Reemplazo de la Válvula Aórtica Transcatéter/instrumentación , Factores de Edad , Anciano , Anciano de 80 o más Años , Válvula Aórtica/diagnóstico por imagen , Válvula Aórtica/fisiopatología , Estenosis de la Válvula Aórtica/diagnóstico por imagen , Estenosis de la Válvula Aórtica/mortalidad , Estenosis de la Válvula Aórtica/fisiopatología , Europa (Continente) , Femenino , Implantación de Prótesis de Válvulas Cardíacas/efectos adversos , Implantación de Prótesis de Válvulas Cardíacas/mortalidad , Humanos , Masculino , Complicaciones Posoperatorias/mortalidad , Complicaciones Posoperatorias/cirugía , Diseño de Prótesis , Reoperación , Estudios Retrospectivos , Medición de Riesgo , Factores de Riesgo , Procedimientos Quirúrgicos sin Sutura/efectos adversos , Procedimientos Quirúrgicos sin Sutura/mortalidad , Factores de Tiempo , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Reemplazo de la Válvula Aórtica Transcatéter/mortalidad , Resultado del Tratamiento
19.
Ann Thorac Surg ; 113(1): 66-74, 2022 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-33771501

RESUMEN

BACKGROUND: With wide expansion of transcatheter aortic valve replacement (TAVR) and dissemination of multidisciplinary-based approaches to care, societies are discussing the implementation of a tier system to valve centers. This study explores the impact of tier-based systems of care on surgical aortic valve replacement (SAVR) outcomes at institutions that perform SAVR only. METHODS: Medicare beneficiaries undergoing SAVR procedures from 2012 to 2015 were included. The SAVR hospitals were stratified into either tier A, valve centers with a TAVR program; or tier B, valve centers without a TAVR program. Adjusted survival, assessed by multivariable Cox regression, controlled for program type and patient risk profile. Time-dependent analysis accounted for hospitals that initiated a TAVR program during the study period. RESULTS: Overall, there were 562 tier A and 485 tier B SAVR hospitals. Tier A hospitals had significantly higher comorbidity burden compared with tier B hospitals (all P < .05) but had significantly lower rates of 30-day mortality (3.2% vs 4.1%) and 1-year mortality (8.1% vs 9.4%; both P < .05). After risk stratification, tier B hospitals had significantly worse 30-day mortality compared with tier A hospitals for all patient risk-profiles, except for the low-risk patients (P < .01). These findings persisted in the time-dependent analysis. Adjusted midterm survival was higher in tier A vs tier B hospitals. CONCLUSIONS: Low-risk patients can safely undergo SAVR in both tier level hospitals without compromising outcomes. Establishment of quality of care measures, especially in the SAVR-only hospitals, remains paramount and should be closely integrated when designing tier-based systems for aortic valve replacement care.


Asunto(s)
Válvula Aórtica/cirugía , Implantación de Prótesis de Válvulas Cardíacas , Anciano , Anciano de 80 o más Años , Atención a la Salud , Femenino , Implantación de Prótesis de Válvulas Cardíacas/efectos adversos , Implantación de Prótesis de Válvulas Cardíacas/mortalidad , Mortalidad Hospitalaria , Humanos , Masculino , Persona de Mediana Edad , Modelos de Riesgos Proporcionales
20.
Ann Thorac Surg ; 113(1): 25-32, 2022 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-33705779

RESUMEN

BACKGROUND: This study aims to comprehensively characterize details of aortic and aortic valve reinterventions after aortic root replacement (ARR). METHODS: Between 2005 and 2019, 882 patients underwent ARR. Indications were aneurysm in 666, aortic valve related in 116, aortic dissection in 64, and infective endocarditis (IE) in 36. Valve-sparing root replacement was performed in 290 patients, whereas a Bio-Bentall procedure was done in 528. Among them, 52 patients (5.9%) required reintervention. The incidence, cause, and time to reintervention and the outcomes after reintervention were investigated. A cause-specific Cox hazard model was performed to identify predictors for reintervention after ARR. RESULTS: The 10-year cumulative incidence of aortic and aortic valve reintervention after ARR was 10.3% (95% confidence interval, 7.3%-14.0%). Age per year decrease was the only independent predictor for reintervention (subdistribution hazard ratio, 0.97; 95% confidence interval, 0.95-0.99). The causes for 52 reinterventions were aortic valve causes in 29 patients (55.8%), including aortic stenosis/insufficiency, and prosthetic valve dysfunction; IE in 15 (28.9%); aortic-related causes in 7 (13.5%), including pseudoaneurysm, development of aneurysm, and residual dissection; and coronary button pseudoaneurysm in 1 (1.9%). Median time to reintervention was 11.0 months (interquartile range, 2.0-20.5) for IE, 24.0 months (interquartile range, 3.7-46.1) for aortic-related causes, and 77.0 months (interquartile range, 28.4-97.6) for aortic valve-related causes (P = .005). Overall in-hospital mortality after the reinterventions was 7.7% (4/52) with 20.0% for IE (3/15). CONCLUSIONS: Reintervention for IE occurred relatively early after ARR, whereas aortic valve- and aortic-related reinterventions gradually increased over time. In-hospital mortality after the reintervention was low, with the exception of IE.


Asunto(s)
Válvula Aórtica/cirugía , Implantación de Prótesis de Válvulas Cardíacas , Adulto , Anciano , Endocarditis/mortalidad , Femenino , Implantación de Prótesis de Válvulas Cardíacas/mortalidad , Mortalidad Hospitalaria , Humanos , Incidencia , Masculino , Persona de Mediana Edad , Modelos de Riesgos Proporcionales , Reoperación/mortalidad , Reoperación/estadística & datos numéricos , Estudios Retrospectivos
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