Experiencia inicial con la prótesis de despliegue rápido en posición aórtica Edwards Intuity

ResumenObjetivoDisponemos de una nueva clase de prótesis aórticas de despliegue rápido para tratamiento quirúrgico de la estenosis aórtica. Permitirían disminuir los tiempos quirúrgicos y facilitarían la cirugía mínimamente invasiva. Presentamos nuestra experiencia inicial con la válvula Edwards Intuity en el contexto del estudio multicéntrico Foundation.Pacientes y métodosEntre septiembre de 2012 y febrero de 2014 se implantaron 25 prótesis aórticas Edwards Intuity en 26 pacientes (77±4,3años; 52% varones). Veinticuatro (96%) fueron reemplazo valvular aislado, y 9 pacientes (36%) tuvieron abordaje mínimamente invasivo. Los pacientes fueron estudiados al alta, a los 3meses y al año de la intervención.ResultadosHubo éxito en el implante en el 96,2% de los pacientes (25/26). No hubo mortalidad hospitalaria. Seguimiento medio de 11±5,4meses, supervivencia acumulada del 96%. Un paciente falleció a los 11meses por un ictus isquémico. El tiempo medio de pinzamiento aórtico fue de 38,2±10,1min y el tiempo medio de circulación extracorpórea, de 62,4±11,1min. A los 3meses, el área valvular efectiva media fue de 1,70±0,42cm2. El 91% de los pacientes (23/25) estaban en grado funcionali en el seguimiento.ConclusionesEl implante de la válvula Edwards Intuity para el tratamiento de la estenosis aórtica ha sido factible, seguro y eficaz. Los tiempos de isquemia miocárdica y de circulación extracorpórea parecen reducirse en comparación con la cirugía valvular aórtica habitual. El comportamiento hemodinámico inicial de la prótesis Edwards Intuity es excelente.AbstractObjectiveA new class of rapid deployment prostheses is now available for surgical treatment of aortic stenosis. These prostheses offer the possibility of reducing the duration of cardiopulmonary bypass and aortic clamping times, and facilitate the use of minimally invasive surgery. We present our initial experience with the Edwards Intuity valve in the context of a multicentre Foundation study.Patients and methodsBetween September 2012 and February 2014, 25 Edwards Intuity valves were implanted in 26 patients (77±4.3years; 52% male). Twenty-four (96%) were isolated aortic valve replacement; a minimally invasive approach was used on 9 patients (36%). Patients were studied at discharge, three months, and one year after surgery.ResultsImplantation success rate was 96.2% (25/26). There was no hospital mortality. Mean follow-up of 11±5.54months, cumulative survival of 96%. One patient died eleven months after surgery due to ischaemic stroke. The mean aortic clamping time was 38.2±10.1minutes, and the mean cardiopulmonary bypass (CPB) time was 62.4±11.1minutes. In the echocardiography at 3months, the mean effective valve area was 1.70±0.42cm2, and 91% of patients (23/25) were in functional classi NYHA at follow-up.ConclusionsThe implantation of the Edwards Intuity valve for surgical treatment of aortic stenosis has shown to be feasible, safe and effective. Times of myocardial ischaemia and extracorporeal circulation appear to be reduced compared with normal aortic valve surgery. The initial haemodynamic performance of the Edwards Intuity prosthesis is excellent

Initial experience with rapid deployment Edwards Intuity aortic valve

© 2015 Sociedad Española de Cirugía Torácica-Cardiovascular. This manuscript version is made available under the CC-BY-NC-ND 4.0 license http://creativecommons.org/licenses/by-nc-nd/4.0/ This document is the Published version of a Published Work that appeared in final form in Cirugía Cardiovascular. To access the final edited and published work see https://doi.org/10.1016/j.circv.2015.07.008Objetivo Disponemos de una nueva clase de prótesis aórticas de despliegue rápido para tratamiento quirúrgico de la estenosis aórtica. Permitirían disminuir los tiempos quirúrgicos y facilitarían la cirugía mínimamente invasiva. Presentamos nuestra experiencia inicial con la válvula Edwards Intuity en el contexto del estudio multicéntrico Foundation. Pacientes y métodos Entre septiembre de 2012 y febrero de 2014 se implantaron 25 prótesis aórticas Edwards Intuity en 26 pacientes (77 ± 4,3 años; 52% varones). Veinticuatro (96%) fueron reemplazo valvular aislado, y 9 pacientes (36%) tuvieron abordaje mínimamente invasivo. Los pacientes fueron estudiados al alta, a los 3 meses y al año de la intervención. Resultados Hubo éxito en el implante en el 96,2% de los pacientes (25/26). No hubo mortalidad hospitalaria. Seguimiento medio de 11 ± 5,4 meses, supervivencia acumulada del 96%. Un paciente falleció a los 11 meses por un ictus isquémico. El tiempo medio de pinzamiento aórtico fue de 38,2 ± 10,1 min y el tiempo medio de circulación extracorpórea, de 62,4 ± 11,1 min. A los 3 meses, el área valvular efectiva media fue de 1,70 ± 0,42 cm2. El 91% de los pacientes (23/25) estaban en grado funcional i en el seguimiento. Conclusiones El implante de la válvula Edwards Intuity para el tratamiento de la estenosis aórtica ha sido factible, seguro y eficaz. Los tiempos de isquemia miocárdica y de circulación extracorpórea parecen reducirse en comparación con la cirugía valvular aórtica habitual. El comportamiento hemodinámico inicial de la prótesis Edwards Intuity es excelente.--------------Objective A new class of rapid deployment prostheses is now available for surgical treatment of aortic stenosis. These prostheses offer the possibility of reducing the duration of cardiopulmonary bypass and aortic clamping times, and facilitate the use of minimally invasive surgery. We present our initial experience with the Edwards Intuity valve in the context of a multicentre Foundation study. Patients and methods Between September 2012 and February 2014, 25 Edwards Intuity valves were implanted in 26 patients (77 ± 4.3 years; 52% male). Twenty-four (96%) were isolated aortic valve replacement; a minimally invasive approach was used on 9 patients (36%). Patients were studied at discharge, three months, and one year after surgery. Results Implantation success rate was 96.2% (25/26). There was no hospital mortality. Mean follow-up of 11 ± 5.54 months, cumulative survival of 96%. One patient died eleven months after surgery due to ischaemic stroke. The mean aortic clamping time was 38.2 ± 10.1 minutes, and the mean cardiopulmonary bypass (CPB) time was 62.4 ± 11.1 minutes. In the echocardiography at 3 months, the mean effective valve area was 1.70 ± 0.42 cm2, and 91% of patients (23/25) were in functional class i NYHA at follow-up. Conclusions The implantation of the Edwards Intuity valve for surgical treatment of aortic stenosis has shown to be feasible, safe and effective. Times of myocardial ischaemia and extracorporeal circulation appear to be reduced compared with normal aortic valve surgery. The initial haemodynamic performance of the Edwards Intuity prosthesis is excellent

Incidence and predictors of sternal surgical wound infection in cardiac surgery: a prospective study

© 2022 The Authors. This manuscript version is made available under the CC-BY-NC-ND 4.0 license http://creativecommons.org/licenses/by-nc-nd/4.0/. This document is the Published version of a Published Work that appeared in final form in International Wound Journal (IWJ). To access the final edited and published work see https://doi.org/10.1111/iwj.13938Sternal surgical wound infection (SSWI) in cardiac surgery is associated with increased morbidity. We investigated the incidence of SSWI, the main germs implicated and predictors of SSWI. Prospective study including patients undergoing full median sternotomy between January 2017 and December 2019. Patients were followed-up for 3 months after hospital discharge. All sternal wound infections up to 90 days after discharge were considered SSWI. 1004 patients were included. During follow-up, 68 (6.8%) patients presented SSWI. Patients with SSWI had a higher incidence of postoperative renal failure (29.4% vs 17.1%, P = .007), a higher incidence of early postoperative reoperation for non-infectious causes (42.6% vs 9.1%, P < .001), longer ICU stay (3 [2–9] days vs 2 [2–4] days, P = .006), and longer hospital stay (24.5 [14.8–38.3] days vs 10 [7–18] days, P < .001). Gram-positive germs were presented in 49% of the cultures, and gram-negative bacteria in 35%. Early reoperation for non-infectious causes (OR 4.90, 95% CI 1.03–23.7), and a longer ICU stay (OR 1.37 95% CI 1.10–1.72) were independent predictors of SSWI. SSWI is rare but leads to more postoperative complications. The need for early reoperation because of non-infectious cause and a longer ICU stay were independently associated with SSWI

Specific NOTCH1 antibody targets DLL4-induced proliferation, migration, and angiogenesis in NOTCH1-mutated CLL cells

Targeting Notch signaling has emerged as a promising therapeutic strategy for chronic lymphocytic leukemia (CLL), particularly in NOTCH1-mutated patients. We provide first evidence that the Notch ligand DLL4 is a potent stimulator of Notch signaling in NOTCH1-mutated CLL cells while increases cell proliferation. Importantly, DLL4 is expressed in histiocytes from the lymph node, both in NOTCH1-mutated and -unmutated cases. We also show that the DLL4-induced activation of the Notch signaling pathway can be efficiently blocked with the specific anti-Notch1 antibody OMP-52M51. Accordingly, OMP-52M51 also reverses Notch-induced MYC, CCND1, and NPM1 gene expression as well as cell proliferation in NOTCH1-mutated CLL cells. In addition, DLL4 stimulation triggers the expression of protumor target genes, such as CXCR4, NRARP, and VEGFA, together with an increase in cell migration and angiogenesis. All these events can be antagonized by OMP-52M51. Collectively, our results emphasize the role of DLL4 stimulation in NOTCH1-mutated CLL and confirm the specific therapeutic targeting of Notch1 as a promising approach for this group of poor prognosis CLL patients

Bronchoscopist's perception of the quality of the single-use bronchoscope (Ambu aScope4™) in selected bronchoscopies: a multicenter study in 21 Spanish pulmonology services

Background: The disposable bronchoscope is an excellent alternative to face the problem of SARS-CoV-2 and other cross infections, but the bronchoscopist’s perception of its quality has not been evaluated. Methods: To evaluate the quality of the Ambu-aScope4 disposable bronchoscope, we carried out a cross-sectional study in 21 Spanish pulmonology services. We use a standardized questionnaire completed by the bronchoscopists at the end of each bronchoscopy. The variables were described with absolute and relative frequencies, measures of cen‑ tral tendency and dispersion depending on their nature. The existence of learning curves was evaluated by CUSUM analysis. Results: The most frequent indications in 300 included bronchoscopies was bronchial aspiration in 69.3% and the median duration of these was 9.1 min. The route of entry was nasal in 47.2% and oral in 34.1%. The average score for ease of use, image, and aspiration quality was 80/100. All the planned techniques were performed in 94.9% and the bronchoscopist was satisfed in 96.6% of the bronchoscopies. They highlighted the portability and immediacy of the aScope4TM to start the procedure in 99.3%, the possibility of taking and storing images in 99.3%. The CUSUM analysis showed average scores>70/100 from the frst procedure and from the 9th procedure more than 80% of the scores exceeded the 80/100 score

Seven years experience with rapid deployment Edwards Intuity aortic prosthesis

© 2020 Sociedad Española de Cirugía Cardiovascular y Endovascular. This manuscript version is made available under the CC-BY-NC-ND 4.0 license http://creativecommons.org/licenses/by-nc-nd/4.0/ This document is the Published version of a Published Work that appeared in final form in Cirugía Cardiovascular. To access the final edited and published work see https://doi.org/10.1016/j.circv.2020.08.002Introducción Las prótesis aorticas de rápido despliegue aparecieron hace 10 años para tratar la estenosis aórtica. El sistema de válvula Edwards Intuity es una prótesis biológica basada en la válvula Edwards Magna con un marco infraanular. Presentamos los resultados clínicos y hemodinámicos a corto y largo plazo obtenidos con esta prótesis biológica. Métodos Ciento diecisiete pacientes (65% varones, 75 ± 4,5 años) con estenosis aórtica (gradiente medio preoperatorio de 49,6 ± 12 mm Hg) recibieron una prótesis Edwards Intuity entre septiembre de 2012 y diciembre de 2019. Se incluyeron en una base de datos prospectiva que recogía diferentes variables. La media de seguimiento fue de 36 ± 21 meses. Resultados Mortalidad hospitalaria del 3,4%, supervivencia al año, a los 3 y 6 años del 95%, 90% y 81%, respectivamente. Se utilizó hemiesternotomía media superior en 78 pacientes (67%). La mediana de tiempos de isquemia miocárdica y de circulación extracorpórea de toda la serie fueron 40 (33-50) minutos y 59 (48-73) minutos. Gradientes medios al alta, al año y a los 2 años fueron 10 ± 4 mm, 9 ± 3,5 mm y 8,4 ± 3,4 mm Hg. Ocho pacientes (7%) necesitaron marcapasos en el postoperatorio. Dos pacientes (0,6%) se reintervinieron en seguimiento por endocarditis y otro (0,3%) se reintervino por fuga periprotésica. Conclusión El sistema de válvula Edwards Intuity presenta buenos resultados clínicos y hemodinámicos a corto y largo plazo. Estas prótesis aórticas se pueden considerar una alternativa a las prótesis convencionales, sobre todo en cirugía de mínimo acceso y en intervenciones complejas.----------------Introduction Rapid deployment aortic valves appeared ten years ago to treat aortic stenosis. The Edwards Intuity Valve System is a biological prosthesis based on the Edwards Magna valve with an infra-annular framework. We present the short and long-term clinical and hemodynamic results obtained with this biological prosthesis. Methods One hundred seventeen patients (65% male, 75 ± 4.5 years) with aortic stenosis (mean preoperative gradient of 49.6 ± 12 mm Hg) received an Edwards Intutiy prosthesis between September 2012 and December 2019. They were included in a prospective data base that collected different variables. The mean follow-up was 36 ± 21 months. Results Hospital mortality of 3.4%. Survival at one, three and six years of 95%, 90% and 81%, respectively. Upper hemisternotomy was used in 78 patients (67%). The median times of myocardial ischemia and extracorporeal circulation for the entire series were 40 (33-50) minutes and 59 (48-73) minutes. Average gradients at discharge, one year and two years were 10 ± 4 mm, 9 ± 3.5 mm and 8.4 ± 3.4 mm Hg. Eight patients (7%) required pacemakers in the postoperative period. Two patients (0.6%) underwent surgery for endocarditis and another (0.3%) underwent surgery for periprosthetic leak. Conclusion The Edwards Intutiy valve system presents good short and long term clinical and hemodynamic results. These aortic prostheses can be considered an alternative to conventional prostheses, especially in minimal access surgery and in complex interventions

Staging Parkinson’s Disease According to the MNCD (Motor/Non-motor/Cognition/Dependency) Classification Correlates with Disease Severity and Quality of Life

Background: Recently, a novel simple classification called MNCD, based on 4 axes (Motor; Non-motor; Cognition; Dependency) and 5 stages, has been proposed to classify Parkinson's disease (PD). Objective: Our aim was to apply the MNCD classification in a cohort of PD patients for the first time and also to analyze the correlation with quality of life (QoL) and disease severity. Methods: Data from the baseline visit of PD patients recruited from 35 centers in Spain from the COPPADIS cohort from January 2016 to November 2017 were used to apply the MNCD classification. Three instruments were used to assess QoL: 1) the 39-item Parkinson's disease Questionnaire [PDQ-39]); PQ-10; the EUROHIS-QOL 8-item index (EUROHIS-QOL8). Results: Four hundred and thirty-nine PD patients (62.05 +/- 7.84 years old; 59% males) were included. MNCD stage was: stage 1, 8.4% (N = 37); stage 2, 62% (N = 272); stage 3, 28.2% (N = 124); stage 4-5, 1.4% (N = 6). A more advanced MNCD stage was associated with a higher score on the PDQ39SI (p < 0.0001) and a lower score on the PQ-10 (p < 0.0001) and EUROHIS-QOL8 (p < 0.0001). In many other aspects of the disease, such as disease duration, levodopa equivalent daily dose, motor symptoms, non-motor symptoms, and autonomy for activities of daily living, an association between the stage and severity was observed, with data indicating a progressive worsening related to disease progression throughout the proposed stages. Conclusion: Staging PD according to the MNCD classification correlated with QoL and disease severity. The MNCD could be a proper tool to monitor the progression of PD

Predictors of Loss of Functional Independence in Parkinson’s Disease: Results from the COPPADIS Cohort at 2-Year Follow-Up and Comparison with a Control Group

COPPADIS Study Group.[Background and objective] The aim of this study was to compare the progression of independence in activities of daily living (ADL) in Parkinson’s disease (PD) patients versus a control group, as well as to identify predictors of disability progression and functional dependency (FD).[Patients and Methods] PD patients and control subjects, who were recruited from 35 centers of Spain from the COPPADIS cohort between January 2016 and November 2017 (V0), were included. Patients and subjects were then evaluated again at the 2-year follow-up (V2). Disability was assessed with the Schwab & England Activities of Daily Living Scale (S&E-ADLS) at V0 and V2. FD was defined as an S&E-ADLS score less than 80%.[Results] In the PD group, a significant decrease in the S&E-ADLS score from V0 to V2 (N = 507; from 88.58 ± 10.19 to 84.26 ± 13.38; p < 0.0001; Cohen’s effect size = −0.519) was observed but not in controls (N = 124; from 98.87 ± 6.52 to 99.52 ± 2.15; p = 0.238). When only patients considered functional independent at baseline were included, 55 out of 463 (11.9%) converted to functional dependent at V2. To be a female (OR = 2.908; p = 0.009), have longer disease duration (OR = 1.152; p = 0.002), have a non-tremoric motor phenotype at baseline (OR = 3.574; p = 0.004), have a higher score at baseline in FOGQ (OR = 1.244; p < 0.0001) and BDI-II (OR = 1.080; p = 0.008), have a lower score at baseline in PD-CRS (OR = 0.963; p = 0.008), and have a greater increase in the score from V0 to V2 in UPDRS-IV (OR = 1.168; p = 0.0.29), FOGQ (OR = 1.348; p < 0.0001) and VAFS-Mental (OR = 1.177; p = 0.013) (adjusted R-squared 0.52; Hosmer and Lemeshow test = 0.94) were all found to be independent predictors of FD at V2.[Conclusions] In conclusion, autonomy for ADL worsens in PD patients compared to controls. Cognitive impairment, gait problems, fatigue, depressive symptoms, more advanced disease, and a non-tremor phenotype are independent predictors of FD in the short-term.Fundación Curemos el Parkinson (www.curemoselparkinson.org).Peer reviewe

Predictors of Global Non-Motor Symptoms Burden Progression in Parkinson’s Disease. Results from the COPPADIS Cohort at 2-Year Follow-Up

COPPADIS Study Group.[Background and Objective] Non-motor symptoms (NMS) progress in different ways between Parkinson’s disease (PD) patients. The aim of the present study was to (1) analyze the change in global NMS burden in a PD cohort after a 2-year follow-up, (2) to compare the changes with a control group, and (3) to identify predictors of global NMS burden progression in the PD group.[Material and Methods] PD patients and controls, recruited from 35 centers of Spain from the COPPADIS cohort from January 2016 to November 2017, were followed-up with after 2 years. The Non-Motor Symptoms Scale (NMSS) was administered at baseline (V0) and at 24 months ± 1 month (V2). Linear regression models were used for determining predictive factors of global NMS burden progression (NMSS total score change from V0 to V2 as dependent variable).[Results] After the 2-year follow-up, the mean NMS burden (NMSS total score) significantly increased in PD patients by 18.8% (from 45.08 ± 37.62 to 53.55 ± 42.28; p < 0.0001; N = 501; 60.2% males, mean age 62.59 ± 8.91) compared to no change observed in controls (from 14.74 ± 18.72 to 14.65 ± 21.82; p = 0.428; N = 122; 49.5% males, mean age 60.99 ± 8.32) (p < 0.0001). NMSS total score at baseline (β = −0.52), change from V0 to V2 in PDSS (Parkinson’s Disease Sleep Scale) (β = −0.34), and change from V0 to V2 in NPI (Neuropsychiatric Inventory) (β = 0.25) provided the highest contributions to the model (adjusted R-squared 0.41; Durbin-Watson test = 1.865).[Conclusions] Global NMS burden demonstrates short-term progression in PD patients but not in controls and identifies worsening sleep problems and neuropsychiatric symptoms as significant independent predictors of this NMS progression.This research was funded by Fundación Española de Ayuda a la Investigación en Parkinson y otras Enfermedades Neuro-degenerativas (Curemos el Parkinson; www.curemoselparkinson.org).Peer reviewe

Staging Parkinson’s Disease According to the MNCD (Motor/Non-motor/Cognition/Dependency) Classification Correlates with Disease Severity and Quality of Life

© 2023 – The authors. Published by IOS Press. This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial License (CC BY-NC 4.0).Background: Recently, a novel simple classification called MNCD, based on 4 axes (Motor; Non-motor; Cognition; Dependency) and 5 stages, has been proposed to classify Parkinson's disease (PD).Objective: Our aim was to apply the MNCD classification in a cohort of PD patients for the first time and also to analyze the correlation with quality of life (QoL) and disease severity.Methods: Data from the baseline visit of PD patients recruited from 35 centers in Spain from the COPPADIS cohort fromJanuary 2016 to November 2017 were used to apply the MNCD classification. Three instruments were used to assess QoL:1) the 39-item Parkinson's disease Questionnaire [PDQ-39]); PQ-10; the EUROHIS-QOL 8-item index (EUROHIS-QOL8).Results: Four hundred and thirty-nine PD patients (62.05±7.84 years old; 59% males) were included. MNCD stage was:stage 1, 8.4% (N = 37); stage 2, 62% (N = 272); stage 3, 28.2% (N = 124); stage 4-5, 1.4% (N = 6). A more advancedMNCD stage was associated with a higher score on the PDQ39SI (p < 0.0001) and a lower score on the PQ-10 (p< 0.0001) and EUROHIS-QOL8 (p< 0.0001). In many other aspects of the disease, such as disease duration, levodopa equivalent daily dose, motor symptoms, non-motor symptoms, and autonomy for activities of daily living, an association between the stage and severity was observed, with data indicating a progressive worsening related to disease progression throughout the proposed stages.Conclusion: Staging PD according to the MNCD classification correlated with QoL and disease severity. The MNCD could be a proper tool to monitor the progression of PD.COPPADIS and the present study were developed with the help of Fundación Española de Ayuda a la Investigación en Enfermedades Neurodegenerativas y/o de Origen Genético (https://fundaciondegen.org/) and Alpha Bioresearch (www.alphabioresearch.com). Also, we received grants from the Spanish Ministry of Economy and Competitiveness [PI16/01575] co-founded by ISCIII (Concesión de subvenciones de Proyectos de Investigación en Salud de la convocatoria 2020 de la Acción Estratégica en Salud 2017-2020 por el Proyecto “PROGRESION NO MOTORA E IMPACTO EN LA CALIDAD DE VIDA EN LA ENFERMEDAD DE PARKINSON”) to develop a part of the COPPADIS project.Peer reviewe