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STUDY OBJECTIVE: The aim of this study was to investigate the efficacy of a two-step patient blood management (PBM) program in red blood cell (RBC) transfusion requirements among patients undergoing elective cardiopulmonary bypass (CPB) surgery. DESIGN: Prospective, non-randomized, two-step protocol design. SETTING: Cardiac surgery department of Clinique Pasteur, Toulouse, France. PATIENTS: 897 patients undergoing for elective CPB surgery. INTERVENTIONS: We conducted a two-steps protocol: PBMe and PBMc. PBMe involved a short quality improvement program for health care workers, while PBMc introduced a systematic approach to pre- and postoperative correction of deficiencies, incorporating iron injections, oral vitamins, and erythropoiesis-stimulating agents. MEASUREMENTS: The PBM program's effectiveness was evaluated through comparison with a pre-PBM retrospective cohort after propensity score matching. The primary objective was the proportion of patients requiring RBC transfusions during their hospital stay. Secondary objectives were also analyzed. MAIN RESULTS: After matching, 343 patients were included in each group. Primary outcomes were observed in 35.7% (pre-PBM), 26.7% (PBMe), and 21.1% (PBMc) of patients, resulting in a significant reduction (40.6%) in the overall RBC transfusion rate. Both the PBMe and PBMc groups exhibited significantly lower risks of RBC transfusion compared to the pre-PBM group, with adjusted odds ratios of 0.59 [95% CI 0.44-0.79] and 0.44 [95% CI 0.32-0.60], respectively. Secondary endpoints included reductions in transfusions exceeding 2 units, total RBC units transfused, administration of allogeneic blood products, and total bleeding volume recorded on Day 1. There were no significant differences noted in mortality rates or the duration of hospital stays. CONCLUSIONS: This study suggests that health care education and systematic deficiency correction are associated with reduced RBC transfusion rates in elective CPB surgery. However, further randomized, controlled studies are needed to validate these findings and refine their clinical application.
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Glomus tumor are rare mesenchymal neoplasm, belonging to the pericytic (perivascular) tumor family, witch recent molecular characterization has allowed highlight recurrent molecular abnormalities. In fact, glomus tumor involves frequent MIR143-NOTCH gene fusion whereas others pericytic tumor (myopericytoma and myofibroma) involve mutations of PDGFRB gene. Glomus tumor are usually developed in superficial localization. However visceral locations have been described. Cardiac location is exceptional with only one case reported in literature. Here, we report the case of cardiac glomus tumor (glomangiomyoma) developed in the left ventricle in a 34 year-old patient, diagnosed after chest pain. The length of tumor was 4cm in greatest dimension. Histologically, the tumor concerned both round glomus cells and smooth muscle cells with prominent branching thin-walled vessels. By immunohistochemistry, these two contingents exhibited diffuse expression of smooth muscle actin and heterogeneous expression of H-caldesmone whereas cytokeratins, melanocytic markers and chomogranine were negative. Next Generation molecular analysis using RNA sequencing highlighted the characteristic MIR143-NOTCH gene fusion witch supports the diagnosis of glomus tumor. In this observation, we recall histological and immunohistochemistry features of glomus tumor and we make a synthesis concerning the molecular data recently described in sporadic glomus tumor.
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Tumor Glómico , MicroARNs , Miofibroma , Adulto , Biomarcadores de Tumor , Tumor Glómico/diagnóstico , Tumor Glómico/cirugía , Humanos , Inmunohistoquímica , PericitosRESUMEN
We present the case, with tomographic three-dimensional reconstructions, of an adult patient affected by congenital absence of one pulmonary valve cusp with completely normal morphology of the other two cusps.
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Válvula Pulmonar , Adulto , Válvula Aórtica , Humanos , Válvula Pulmonar/diagnóstico por imagen , Válvula Pulmonar/cirugía , Tomografía Computarizada por Rayos XRESUMEN
OBJECTIVES: Although in younger patients indications for biological prosthesis implantation in mitral valve replacement remain controversial, recently bioprostheses use increased considerably. We present late results obtained with the Medtronic Mosaic bioprosthesis in patients aged 65 years or younger. METHODS: Between 2007 and 2017, 67 mitral Mosaic bioprostheses were implanted in patients aged 65 years or younger (58.5 ± 6.4 years). Follow-up extended up to 13 years. Survival, freedom from structural valve degeneration, endocarditis, thromboembolic events and reoperation were considered as main clinical end points evaluated at 1, 5 and 10 years. RESULTS: The mean follow-up was 4.7 ± 2.8 years. Overall mortality rate was 12%. At 1, 5 and 10 years, survival was 94 ± 3%, 89 ± 4% and 77 ± 9%, respectively. Freedom from structural valve degeneration was 100%, 94 ± 4% and 71 ± 21%. Freedom from endocarditis was 95 ± 3%, 90 ± 6% and 84 ± 8%. Freedom from thromboembolic events was 94 ± 3%, 90 ± 5% and 90 ± 5%. Freedom from reoperation was 94 ± 3%, 87 ± 5% and 65 ± 19%. CONCLUSIONS: Mosaic bioprosthesis appears a valid mitral valve substitute even when employed in ≤65-year-old patients.
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Bioprótesis , Implantación de Prótesis de Válvulas Cardíacas , Prótesis Valvulares Cardíacas , Anciano , Válvula Aórtica/cirugía , Estudios de Seguimiento , Implantación de Prótesis de Válvulas Cardíacas/efectos adversos , Humanos , Válvula Mitral/diagnóstico por imagen , Válvula Mitral/cirugía , Diseño de Prótesis , Falla de Prótesis , ReoperaciónRESUMEN
Anaemia and iron deficiency are frequent in patients scheduled for cardiac surgery. Perioperative patient blood management (PBM) is widely recommended in current practice guidelines. The aim of this protocol is to analyse the effect of a global perioperative PBM programme on the red blood cell (RBC) transfusion ratio, morbidities and rehabilitation score in elective cardiac surgery.This study is a prospective, single-centre trial with a 2-step protocol, A and B, as follows: A: non-drug intervention: the caregiver is given a blood management educational programme; B: drug intervention: systematic correction of perioperative iron, vitamin deficiencies, and anaemia. This study was designed to enrol 900 patients (500 in group A and 400 in group B) in a rolling period starting at anaesthesia consultation and ending 3 months after surgery. The primary objective was a 20% reduction in RBC transfusion after implementation of PBM programmes (protocol A + B) when compared to our previous transfusion ratio in the first half of 2018 (30.4% vs 38%). The secondary objectives were to evaluate the impact for each step of the study on the RBC transfusion rate, morbidity and the quality of postoperative rehabilitation.The strength of this study is its evaluation of the effect of a global PBM programme on RBC transfusion in cardiac surgery through a 2-step protocol. We aim to assess for the first time the impact of non-drug and drug interventions on RBC transfusion, comorbidities and delayed rehabilitation parameters. TRIALS REGISTRATIONS: ClinicalTrials.gov, NCT04040023: registered 29 July 2019.
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AIMS: Transcatheter mitral valve replacement (TMVR) is a promising therapeutic solution to treat high-risk patients with severe mitral regurgitation (MR) contraindicated to surgery. Optimal selection of patients who will benefit from the procedure is of paramount importance. We aimed to investigate factors associated with TMVR screening. METHODS AND RESULTS: From November 2016 to July 2018, we examined conditions associated with TMVR screening success in patients referred to the two French heart valve clinics with the greatest TMVR experience. Among a total of 40 consecutively screened patients, 16 (40%) were selected for TMVR (8 Twelve Intrepid, 7 Tendyne and 1 HighLife), while 24 patients (60%) were refused for TMVR mainly because of a too large mitral annulus (MA) (n=15, 62% of those refused), or too small anatomy and risk of neo-left ventricular outflow tract (LVOT) obstruction (n=6, 25% of those refused). Patients with suitable anatomy for TMVR were more often male and more frequently suffered from secondary MR (p=0.01) associated with previous myocardial infarction and presented a commissure-to-commissure diameter less than 39 mm (AUC=0.72, p=0.0085) and LVESD greater than 32 mm (AUC=0.83, p<0.0001) on transthoracic echocardiography, and an MA area less than 17.6 cm² (AUC=0.95, p<0.0001) and anteroposterior diameter greater than 41.6 mm (AUC=0.87, p<0.001) on CT scan. CONCLUSIONS: Despite several prostheses being available, most patients referred to heart valve clinics who are good candidates with regard to their clinical profile cannot have TMVR because of mismatch between their anatomy and prosthesis characteristics. Our findings suggest the need to develop new prostheses adapted to larger mitral annuli but with a lower impact on the LVOT.
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Implantación de Prótesis de Válvulas Cardíacas , Insuficiencia de la Válvula Mitral , Cateterismo Cardíaco , Humanos , Masculino , Tamizaje Masivo , Válvula Mitral , Insuficiencia de la Válvula Mitral/cirugía , Resultado del TratamientoRESUMEN
OBJECTIVES: The aim of this study was to analyze the incidence, impact, and predictors of cerebrovascular events (CVEs) in patients undergoing transcatheter aortic valve replacement (TAVR). BACKGROUND: Several issues remain unresolved post-TAVR, including CVEs. METHODS: The FRANCE-2 (French Aortic Nation CoreValve and Edwards-2) registry prospectively included all patients who underwent TAVR in France and Monaco from January 2010 to October 2011. A total of 3,191 patients were analyzed. Six-month follow-up data were obtained. Events were adjudicated according to Valve Academic Research Consortium (VARC)-1 definition. RESULTS: Of the cohort, 3.98% experienced a CVE: 55% were major strokes, 14.5% minor strokes, and 30.5% transient ischemic attacks. The mean delay for CVE occurrence was 2 days (interquartile range: 0 to 7 days) with 48.5% of CVEs occurring within 2 days. There was no statistically significant difference in CVE rate with regard to the type of valve (p = 0.899) and the access route (p = 0.128). Patients with a CVE more frequently had new-onset paroxysmal atrial fibrillation (13.6% vs. 7.6%; p = 0.015). During follow-up, the unadjusted mortality rate was higher in patients with a CVE (26% vs. 16.5%; p = 0.002). By multivariate analysis, only advanced age (odds ratio: 1.05; 95% confidence interval: 1.02 to 1.08; p = 0.02) and having 2 valves implanted (odds ratio: 3.13; 95 confidence interval: 1.40 to 7.05; p = 0.006) were associated with a significant risk of CVEs. CONCLUSIONS: CVEs occur frequently after TAVR and are associated with an increased mortality rate. No difference exists in the CVE rate when exploring the type of valve or the access route. Advanced age and multiple valves implanted during the same procedure are predictors of CVE.
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Estenosis de la Válvula Aórtica/terapia , Cateterismo Cardíaco/efectos adversos , Implantación de Prótesis de Válvulas Cardíacas/efectos adversos , Ataque Isquémico Transitorio/epidemiología , Accidente Cerebrovascular/epidemiología , Factores de Edad , Anciano , Anciano de 80 o más Años , Estenosis de la Válvula Aórtica/diagnóstico , Estenosis de la Válvula Aórtica/mortalidad , Fibrilación Atrial/epidemiología , Cateterismo Cardíaco/métodos , Cateterismo Cardíaco/mortalidad , Femenino , Francia/epidemiología , Implantación de Prótesis de Válvulas Cardíacas/métodos , Implantación de Prótesis de Válvulas Cardíacas/mortalidad , Humanos , Incidencia , Ataque Isquémico Transitorio/diagnóstico , Ataque Isquémico Transitorio/mortalidad , Estimación de Kaplan-Meier , Modelos Logísticos , Masculino , Mónaco/epidemiología , Análisis Multivariante , Oportunidad Relativa , Sistema de Registros , Factores de Riesgo , Índice de Severidad de la Enfermedad , Accidente Cerebrovascular/diagnóstico , Accidente Cerebrovascular/mortalidad , Factores de Tiempo , Resultado del TratamientoRESUMEN
BACKGROUND: There are no direct comparisons between transapical aortic valve implantation (TA-AVI) and transfemoral aortic valve implantation (TF-AVI). Therefore, the aim of this study was to compare the short-term and midterm outcomes of TA-AVI versus TF-AVI. METHODS: Data from four European centers were pooled and analyzed. To minimize differences between TA-AVI and TF-AVI multivariable analysis was used. Study endpoints were defined according to the Valve Academic Research Consortium-I criteria at 30 days and 1 year. Primary endpoints of this study were 30-day all-cause mortality and mortality during follow-up. RESULTS: A total of 882 patients underwent TAVI, of whom 793 (89.9%) underwent TF-AVI and 89 (10.1%) underwent TA-AVI. Patients undergoing TA-AVI had a higher estimated risk of mortality as defined by the logistic European System for Cardiac Operative Risk Evaluation score (median 27.0, interquartile range [IQR]: 20.2 to 33.8 versus median 20.0, IQR: 12.3 to 27.7; p < 0.001) and The Society of Thoracic Surgeons Score (median 10.2, IQR: 5.3 to 9.9 versus median 6.7, IQR: 3.5 to 9.9; p < 0.001) and had more comorbidities. At 30 days, there was an increased risk of all-cause mortality in the TA-AVI group (odds ratio [OR] 3.12, 95% confidence interval [CI]: 1.43 to 6.82; p = 0.004). TF-AVI was associated with a higher frequency of major (OR 0.33, 95% CI: 0.12 to 0.90; p = 0.031) and minor vascular complications (OR 0.17, 95% CI: 0.04 to 0.71; p = 0.0015). In-hospital stay was significantly longer among patients undergoing TA-AVI (OR 2.29, 95% CI: 1.28 to 4.09; p = 0.05). During a median follow-up of 365 days (IQR: 174 to 557), TA-AVI was associated with an increased risk of all-cause mortality (hazard ratio 1.88, 95% CI: 1.23 to 2.87; p = 0.004). CONCLUSIONS: In institutions performing a low volume of TA-AVI, the technique is associated with an increased risk of all-cause mortality and longer hospital stay but less vascular complications in comparison with TF-AVI. The interaction between experience and type of treatment on outcome requires further investigation before advocating one treatment over the other.
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Estenosis de la Válvula Aórtica/cirugía , Diagnóstico por Imagen/métodos , Procedimientos Endovasculares/métodos , Implantación de Prótesis de Válvulas Cardíacas/mortalidad , Implantación de Prótesis de Válvulas Cardíacas/métodos , Anciano , Anciano de 80 o más Años , Estenosis de la Válvula Aórtica/diagnóstico , Estenosis de la Válvula Aórtica/mortalidad , Cateterismo Cardíaco/métodos , Estudios de Cohortes , Intervalos de Confianza , Educación Médica Continua , Procedimientos Endovasculares/mortalidad , Europa (Continente) , Femenino , Vena Femoral , Estudios de Seguimiento , Prótesis Valvulares Cardíacas , Mortalidad Hospitalaria , Humanos , Estimación de Kaplan-Meier , Tiempo de Internación , Modelos Logísticos , Masculino , Análisis Multivariante , Oportunidad Relativa , Seguridad del Paciente , Modelos de Riesgos Proporcionales , Estudios Retrospectivos , Medición de Riesgo , Índice de Severidad de la Enfermedad , Tasa de Supervivencia , Resultado del TratamientoRESUMEN
BACKGROUND: Only limited and conflicting data on the impact of preoperative chronic kidney disease (CKD) on outcomes after transcatheter aortic valve implantation (TAVI) are available. METHODS: We retrospectively analyzed pooled data from the prospective TAVI databases of 4 centers (942 patients). Valve Academic Research Consortium end point definitions were used. The outcomes were compared among patients with normal estimated glomerular filtration rate (≥90 mL/min), mild (60-89 mL/min), moderate (30-59 mL/min), and severe (<30 mL/min) CKD and those on chronic hemodialysis (HD). The primary end point was 1-year survival. RESULTS: A total of 109 patients had a normal estimated glomerular filtration rate (11.6%); 329 (34.9%) had mild, 399 (42.5%) moderate, 72 (7.5%) severe CKD, and 33 (3.5%) were on HD. Baseline and procedural characteristics were similar among all groups except for Logistic EuroSCORE. Major stroke, life-threatening bleeding, all-cause 30-day mortality (HD 15.2%, severe CKD 8.3%, moderate CKD 8.3%, mild CKD 6.7%, normal 1.8%, P = .007) and 1-year survival (HD 54.8%, severe CKD 67.2%, moderate CKD 80.0%, mild CKD 85.2%, normal eGFR 91.4%, HD vs severe CKD P = .23, severe CKD vs moderate CKD P = .002, moderate CKD vs mild CKD P = .04, moderate CKD vs normal eGFR P = .03, by log-rank test) differed significantly across groups. Through multivariable analysis, HD and severe CKD were independently associated with an increased risk of 1-year mortality (hazard ratios 5.07 [95% CI 1.79-14.35, P = .002] and 4.03 [95% CI 1.52-10.69, P = .005], respectively). CONCLUSIONS: Patients with CKD who undergo TAVI have a higher-risk profile and worse 30-day and 1-year outcomes. Chronic hemodialysis and severe preprocedural CKD are independently associated with an increased risk of 1-year mortality after TAVI.
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Estenosis de la Válvula Aórtica/cirugía , Válvula Aórtica/cirugía , Cateterismo Cardíaco/métodos , Implantación de Prótesis de Válvulas Cardíacas/métodos , Insuficiencia Renal Crónica/complicaciones , Anciano , Anciano de 80 o más Años , Estenosis de la Válvula Aórtica/complicaciones , Estenosis de la Válvula Aórtica/mortalidad , Femenino , Estudios de Seguimiento , Francia/epidemiología , Tasa de Filtración Glomerular , Humanos , Masculino , Países Bajos/epidemiología , Estudios Prospectivos , Insuficiencia Renal Crónica/mortalidad , Insuficiencia Renal Crónica/fisiopatología , Factores de Riesgo , Tasa de Supervivencia/tendenciasRESUMEN
BACKGROUND: Transfemoral transcatheter aortic valve implantation (TF-TAVI) is a viable and safe treatment strategy for patients with symptomatic severe aortic stenosis and high operative risk and has been introduced as such in the recently updated European guidelines on the management of valvular heart disease.Our aim was to assess trends in outcome after TF-TAVI. METHODS: Propensity score-matched analysis of a multicenter registry of consecutive patients undergoing TF-TAVI subdivided into 3 tertiles based on enrollment date was performed. Three tertiles of 214 propensity score-matched patients were compared. RESULTS: With mounting experience and moving from the initial to the last cohort, procedural contrast volume and radiation time decreased. Over time, there were less major vascular complications (15% vs 7.9%, P = .023), life-threatening bleedings (17.8% vs 7.9%, P = .003), and major bleedings (22.4% vs 12.1%, P = .007). Major vascular complications and life-threatening bleedings caused by closure device failure decreased significantly (9.2% vs 3.1% [P = .01] and 5.7% vs 1 % [P = .01], respectively). The combined safety end point dropped from 31.3% in tertile (T) (T1) to 17.8% in T3 (P < .001). By multivariable analysis, the last cohort as compared with the initial cohort was associated with significant reductions in 30-day mortality (odds ratio [OR] 0.35, 95% CI 0.12-0.96), stage 3 AKI (OR 0.12, 95% CI 0.29-0.93), and the combined safety end point (OR 0.52, 95% CI 0.29-0.93). One-year survival improved significantly (T1 79% vs T3 86%, P = .016). CONCLUSIONS: Over time, TAVI is performed with significant reductions in major vascular complications, life-threatening bleedings, and the combined clinical safety end point and improved 1-year survival.
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Estenosis de la Válvula Aórtica/cirugía , Cateterismo Cardíaco/métodos , Implantación de Prótesis de Válvulas Cardíacas/métodos , Complicaciones Posoperatorias/mortalidad , Sistema de Registros , Anciano de 80 o más Años , Causas de Muerte/tendencias , Europa (Continente)/epidemiología , Femenino , Arteria Femoral , Estudios de Seguimiento , Humanos , Masculino , Oportunidad Relativa , Puntaje de Propensión , Estudios Retrospectivos , Factores de Riesgo , Resultado del TratamientoRESUMEN
OBJECTIVES: The aim of this study was to compare outcomes after transfemoral transcatheter aortic valve implantation with the Medtronic CoreValve (MCV) versus the Edwards SAPIEN/SAPIEN XT transcatheter heart valve (ESV) for severe aortic stenosis. BACKGROUND: No large matched comparison study has been conducted so far evaluating both commercially available devices. METHODS: The data from databases of 4 experienced European centers were pooled and analyzed. Due to differences in baseline clinical characteristics, propensity score matching was performed. Study objectives were Valve Academic Research Consortium outcomes at 30 days and 1 year. RESULTS: In total, 793 patients were included: 453 (57.1%) treated with the MCV and 340 (42.9%) with the ESV. After propensity matching, 204 patients were identified in each group. At 30 days, there were no differences in all-cause mortality (MCV, 8.8% vs. ESV, 6.4%; hazard ratio [HR]: 1.422; 95% confidence interval [CI]: 0.677 to 2.984; p = 0.352), cardiovascular mortality (MCV, 6.9% vs. ESV, 6.4%; HR: 1.083; 95% CI: 0.496 to 2.364; p = 0.842), myocardial infarction (MCV, 0.5% vs. ESV, 1.5%; HR: 0.330; 95% CI: 0.034 to 3.200; p = 0.339), stroke (MCV, 2.9% vs. ESV, 1.0%; HR: 3.061; 95% CI: 0.610 to 15.346; p = 0.174), or device success (MCV, 95.6% vs. ESV, 96.6%; HR: 0.770; 95% CI: 0.281 to 2.108; p = 0.611). Additionally, there were no differences in major vascular complications (MCV, 9.3% vs. ESV, 12.3%; HR: 0.735; 95% CI: 0.391 to 1.382; p = 0.340) or life-threatening bleeding (MCV, 13.7% vs. ESV, 8.8%; HR: 1.644; 95% CI: 0.878 to 3.077; p = 0.120). MCV was associated with more permanent pacemakers (22.5% vs. 5.9%; HR: 4.634; 95% CI: 2.373 to 9.050; p < 0.001). At 1 year, there were no differences in all-cause (MCV, 16.2% vs. ESV, 12.3%; HR: 1.374; 95% CI: 0.785 to 2.407; p = 0.266) or cardiovascular (MCV, 8.3% vs. ESV, 7.4%; HR: 1.145; 95% CI: 0.556 to 12.361; p = 0.713) mortality. CONCLUSIONS: No differences between the 2 commercially available transfemoral transcatheter aortic valve implantation devices were observed at the adjusted analysis in Valve Academic Research Consortium outcomes except for the need for permanent pacemakers with the MCV.
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Estenosis de la Válvula Aórtica/cirugía , Cateterismo Cardíaco/métodos , Implantación de Prótesis de Válvulas Cardíacas , Prótesis Valvulares Cardíacas , Complicaciones Posoperatorias/epidemiología , Diseño de Prótesis , Enfermedades Vasculares , Anciano , Anciano de 80 o más Años , Válvula Aórtica/cirugía , Estenosis de la Válvula Aórtica/diagnóstico , Estenosis de la Válvula Aórtica/fisiopatología , Investigación sobre la Eficacia Comparativa , Femenino , Pruebas de Función Cardíaca , Prótesis Valvulares Cardíacas/efectos adversos , Prótesis Valvulares Cardíacas/estadística & datos numéricos , Implantación de Prótesis de Válvulas Cardíacas/efectos adversos , Implantación de Prótesis de Válvulas Cardíacas/instrumentación , Implantación de Prótesis de Válvulas Cardíacas/métodos , Implantación de Prótesis de Válvulas Cardíacas/mortalidad , Humanos , Masculino , Evaluación de Resultado en la Atención de Salud , Vigilancia de Productos Comercializados , Puntaje de Propensión , Estudios Retrospectivos , Índice de Severidad de la Enfermedad , Análisis de Supervivencia , Tasa de Supervivencia , Enfermedades Vasculares/epidemiología , Enfermedades Vasculares/etiologíaRESUMEN
Better outcomes have been reported after percutaneous cardiac intervention in obese patients ("obesity paradox"). However, limited information is available on the effect of the body mass index on the outcomes after transcatheter aortic valve implantation (TAVI). We, therefore, sought to determine the effect of the body mass index on the short- and long-term outcomes in patients who underwent TAVI. The population consisted of 940 patients, of whom 25 (2.7%) were underweight, 384 had a (40.9%) normal weight, 372 (39.6%) were overweight, and 159 (16.9%) were obese. Overall, the obese patients were younger (79.7 ± 6.4 years vs 81.7 ± 7.3 and 80.8 ± 7.0 years, p = 0.008) and had a greater prevalence of preserved left ventricular and renal function. On univariate analysis, obese patients had a greater incidence of minor stroke (1.3% vs 0 and 0.3%, p = 0.03), minor vascular complications (15.7% vs 9.1% and 11.6%, p = 0.028) and acute kidney injury stage I (23.3% vs 10.7% and 16.1%, p <0.001). After adjustment, body mass index, as a continuous variable, was associated with a lower risk of mortality at 30 days (odds ratio 0.93, 95% confidence interval 0.86 to 0.98, p = 0.023) and no effect on survival after discharge (hazard ratio 1.01, 95% confidence interval 0.96 to 1.07, p = 0.73). In conclusion, obesity was associated with a greater incidence of minor, but no major, perioperative complications after TAVI. After adjustment, obesity was associated with a lower risk of 30-day mortality and had no adverse effect on mortality after discharge, underscoring the "obesity paradox" in patients undergoing TAVI.
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Estenosis de la Válvula Aórtica/cirugía , Índice de Masa Corporal , Cateterismo Cardíaco/métodos , Prótesis Valvulares Cardíacas , Obesidad/complicaciones , Medición de Riesgo/métodos , Válvula Aórtica , Estenosis de la Válvula Aórtica/complicaciones , Estenosis de la Válvula Aórtica/mortalidad , Europa (Continente)/epidemiología , Estudios de Seguimiento , Mortalidad Hospitalaria/tendencias , Humanos , Estimación de Kaplan-Meier , Tiempo de Internación , Obesidad/mortalidad , Oportunidad Relativa , Periodo Posoperatorio , Factores de Riesgo , Factores de Tiempo , Resultado del TratamientoRESUMEN
AIMS: High rates of permanent pacemaker (PPM) implantation are reported after transcatheter aortic valve implantation (TAVI) using the Medtronic CoreValve® system. The Accutrak™ catheter is designed to allow a more predictable landing zone. Little is known about the real clinical impact of this catheter. The aims of this paper were to describe the potential impact of the Accutrak™ catheter on the accuracy of positioning a 26 or 29 mm CoreValve® across the aortic annulus and its impact on the need for a pacemaker. METHODS AND RESULTS: A total of 134 patients were treated with the CoreValve® Accutrak™ system at two French centres (Lille and Toulouse). Mean age was 82.4 ± 4.7 years; logistic EuroSCORE was 24.3 ± 9.5%. Procedural success rate was 99.2%; mean depth of implantation was 4.9 mm. A final position between 0 and 6 mm was achieved in 85.8% of the patients. All-cause mortality at 30 days was 6%. The PPM implantation rate was 10.6%. Due to a limited number of events, we could not identify any predictor of need for a PPM: pre-existing right bundle branch block (RBBB) (OR 2.72 [0.63-11.87], p=ns), use of a 29 mm prosthesis (OR 2.73 [0.33-22.90], p=ns) and left ventricular septal hypertrophy (OR 2.63 [0.08-83.32], p=ns). CONCLUSIONS: In this cohort of patients treated with the CoreValve® Accutrak™ system, the incidence of permanent pacemaker implantation was low, which may be a consequence of an average small implantation depth. The Accutrak™ catheter seems to be helpful in achieving higher and more predictable implants. Operators could standardise their technique to place the CoreValve® prostheses less than 6 mm below the aortic annulus.
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Válvula Aórtica/cirugía , Catéteres , Implantación de Prótesis de Válvulas Cardíacas/métodos , Marcapaso Artificial , Anciano , Anciano de 80 o más Años , Cateterismo Cardíaco , Femenino , Implantación de Prótesis de Válvulas Cardíacas/instrumentación , Humanos , Masculino , Resultado del TratamientoRESUMEN
Our study objective was to assess the incidence, predictors, and implications of access site complications related to transfemoral transcatheter aortic valve implantation (TAVI). We pooled the prospective TAVI databases of 5 experienced centers in Europe enrolling only transfemoral cases for this analysis. Access site complications were defined according to the Valve Academic Research Consortium end-point definitions. The global transfemoral TAVI database contained 986 patients. Percutaneous access and closure was performed in 803 patients (81%) and a surgical strategy in 183 (19%). Incidences of major vascular complications, life-threatening/disabling bleeding, and major bleeding were 14.2%, 11%, and 17.8% respectively. In the patient cohort with a completely percutaneous access strategy, major vascular complications and life-threatening/disabling bleedings were related to closure device failure in 64% and 29%, respectively. Female gender (odds ratio 1.63, 95% confidence interval 1.12 to 2.36) and use of >19Fr system (2.87, 1.68 to 4.91) were independent predictors for major vascular complications. Female gender (odds ratio 2.04, 95% confidence interval 1.31 to 3.17), use of >19Fr system (1.86, 1.02 to 3.38), peripheral arterial disease (2.14, 1.27 to 3.61), learning effect (0.45, 0.27 to 0.73), and percutaneous access strategy (2.39, 1.16 to 4.89) were independently associated with life-threatening/disabling bleedings. In conclusion, transfemoral TAVI is associated with a >10% incidence of major vascular-related complications. A considerable number of these events is related to arteriotomy closure failure. Arterial sheath size and female gender are important determinants of major vascular complications and life-threatening/disabling bleeding.
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Estenosis de la Válvula Aórtica/terapia , Arteria Femoral , Prótesis Valvulares Cardíacas , Dispositivos de Acceso Vascular/efectos adversos , Enfermedades Vasculares/epidemiología , Distribución por Edad , Anciano , Anciano de 80 o más Años , Estenosis de la Válvula Aórtica/diagnóstico por imagen , Cateterismo Periférico/efectos adversos , Estudios de Cohortes , Intervalos de Confianza , Bases de Datos Factuales , Femenino , Estudios de Seguimiento , Implantación de Prótesis de Válvulas Cardíacas/métodos , Humanos , Incidencia , Masculino , Oportunidad Relativa , Estudios Retrospectivos , Medición de Riesgo , Índice de Severidad de la Enfermedad , Distribución por Sexo , Resultado del Tratamiento , Ultrasonografía , Enfermedades Vasculares/etiologíaRESUMEN
INTRODUCTION: Recent expert consensus guidelines mention that one of the principles for infected device replacement following removal is to "reevaluate carefully if there is a continued need for a new cardiac device replacement." This is a Class I recommendation, which nevertheless suffers from a very low level of evidence (level of evidence C), since no study has revisited the systematic practice of reimplanting the same device based on a meticulous clinical reassessment. In the present paper, we examined the safety of withholding the implantation of pacing systems in selected patients. METHODS AND RESULTS: Between January 2005 and December 2007, 188 consecutive patients underwent extractions of infected pacing systems at 2 medical centers. "Low-risk" patients were identified by (1) a spontaneous heart rate >45 bpm, (2) no symptomatic asystole during monitoring, (3) QRS duration <120 ms when history of AV block was noted, (4) no high-degree AV block during continuous monitoring. They remained device-free, unless an adverse clinical event occurred mandating the reimplantation. The primary study endpoint was rate of sudden death and syncope after a 12-month follow-up. Among the 74 (39.4%) "low-risk" patients, a single patient suffered a bradycardia-related syncopal event corresponding to a 1.3% (95% CI, 0.0-3.9) rate of primary endpoint. Pacing systems were also reimplanted in 24 patients (32.4%) for syncope (n = 1), nonsevere bradycardia-reated symptoms (n = 17), cardiac resynchronization (n = 2), and for reassurance in 4 asymptomatic patients. CONCLUSION: After removal of infected pacing systems, these preliminary data demonstrated that a strategy of nonsystematic device reimplantation associated with close surveillance was safe in "low-risk" patients, allowing the administration of antimicrobials in a device-free state.
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Marcapaso Artificial , Implantación de Prótesis , Infecciones Relacionadas con Prótesis/cirugía , Anciano , Arritmias Cardíacas/fisiopatología , Arritmias Cardíacas/terapia , Bloqueo Atrioventricular/complicaciones , Muerte Súbita Cardíaca/epidemiología , Femenino , Estudios de Seguimiento , Frecuencia Cardíaca/fisiología , Humanos , Masculino , Persona de Mediana Edad , Marcapaso Artificial/efectos adversos , Implantación de Prótesis/efectos adversos , Reoperación , Medición de Riesgo , Choque Séptico/complicaciones , Resultado del TratamientoRESUMEN
PURPOSE: We measured the proportion of intravascular leads, which can be extracted by simple traction versus with newer techniques, and examined the overall safety and success rate of lead extractions. METHODS: Between January 2005 and December 2007, 311 consecutive patients (mean age = 70 +/- 14 years, 79% men) underwent extractions of 250 atrial, 318 ventricular, and 22 coronary sinus leads, in the surgical facilities of two experienced medical centers, under general anesthesia, at a mean of 7.2 +/- 5.1 years (range 0.1-27.0) after lead implantation. Infection was the indication for extraction in 67.5% of cases. Complementary techniques were used when simple extraction with a locking stylet was unsuccessful. RESULTS: Simple traction, with or without a locking stylet, allowed the complete removal in 27.0% (95% confidence interval [CI] 22.1-31.9) of patients. A mechanical sheath, laser sheath, and/or lasso catheter were used in the remaining patients. The overall extraction success rate was 89.7% (95% CI 86.3-93.1). There was one procedure-related death (0.3%; 95% CI 0.0-1.0). Among five other deaths occurring within 10 days after the procedure, four were due to septic shock. Duration of lead implantation was the strongest independent predictor of major adverse events (P = 0.002) and incomplete lead extraction (P = 0.005). CONCLUSION: In contrast with simple traction, advanced techniques allowed the complete extraction of nearly 90% of leads. In experienced hands and with surgical back-up, these techniques were safe. Patients presenting with infected implanted cardiac devices suffered a high rate of major adverse despite complete extraction of the lead(s).
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Remoción de Dispositivos/mortalidad , Remoción de Dispositivos/métodos , Electrodos Implantados/estadística & datos numéricos , Marcapaso Artificial/estadística & datos numéricos , Falla de Prótesis , Infecciones Relacionadas con Prótesis/epidemiología , Medición de Riesgo/métodos , Anciano , Remoción de Dispositivos/instrumentación , Femenino , Francia/epidemiología , Humanos , Incidencia , Masculino , Estudios Retrospectivos , Factores de Riesgo , Análisis de Supervivencia , Tasa de SupervivenciaAsunto(s)
Bradicardia/terapia , Electrodos Implantados , Falla de Equipo , Trastornos Mentales/complicaciones , Marcapaso Artificial/psicología , Conducta Autodestructiva/psicología , Síndrome del Seno Enfermo/terapia , Bradicardia/psicología , Femenino , Humanos , Trastornos Mentales/psicología , Persona de Mediana Edad , Conducta Autodestructiva/complicaciones , Síndrome del Seno Enfermo/psicologíaRESUMEN
Fistulas complicating an abdominal aortic aneurysm (AAA) are rare, and fistulas involving the left renal vein are particularly uncommon. We highlight here a fistula between an infrarenal aortic aneurysm and a retroaortic left renal vein, revealed by left flank pain associated with hematuria and acute renal failure. The multislice CT angiography performed in this 68-year-old patient revealed communication and equal enhancement between the aorta and the left gonadic vein, suggesting the presence of a fistula. The three-dimensional VRT reconstructions presented in this case were of great value in the preoperative planning, enabling immediate visualization of this unusual feature. Alternative diagnoses to consider when encountering this clinical presentation are reviewed.