Primary neonatal and pediatric ECMO transport: First experience in Spain.

INTRODUCTION: The organization of primary Extracorporeal membrane oxygenation (ECMO) transport is highly variable. METHODS: To present the experience of the first mobile pediatric ECMO program in Spain, we designed a prospective descriptive study of all primary neonatal and pediatric (0-16 years) ECMO transports carried out over 10 years. The main variables recorded include demographic information, patient background, clinical data, ECMO indications, adverse events, and main outcomes. RESULTS: 39 primary ECMO transports were carried out with a 66.7% survival to hospital discharge. The median age was 1.24 months[IQR: 0.09-96]. Cannulation was mostly peripheral venoarterial (33/39). The mean response time from the call from the sending center to the departure of the ECMO team was 4 h[2.2-8]. The median inotropic score at the time of cannulation was 70[17.2-206.5], with a median oxygenation index of 40.5[29-65]. In 10% of the cases, ECMO-CPR was performed. Adverse events occurred in 56.4%, mostly related to the means of transport (40% overall). On arrival at the ECMO center, 44% of the patients underwent interventions. The median PICU stay was 20.5 days[11-32]. 5 patients developed neurological sequels. Statistically significant differences between survivors and deceased patients were not found. CONCLUSIONS: A good survival rate, with a low prevalence of serious adverse events, suggests a clear benefit of primary ECMO transport when conventional therapeutic measures are exhausted and the patient is too unstable to undergo conventional transport. A nationwide primary ECMO-transport program must therefore be offered to all patients regardless of their location.

Esperanza de vida después del recambio valvular debido a estenosis aórtica de bajo gradiente con función ventricular conservada / Life expectancy after surgical aortic valve replacement for low-gradient aortic stenosis with preserved ejection fraction

Introducción y objetivos: El recambio valvular aórtico (RVAo) quirúrgico puede modificar la historia natural de la estenosis aórtica grave (EAoG). Sin embargo, comparado con la población general, estos pacientes tienen una pérdida en su esperanza de vida. La esperanza de vida de los pacientes intervenidos de RVAo debido a EAoG de bajo gradiente con fracción de eyección del ventrículo izquierdo (FEVI) conservada se desconoce. Métodos: Se incluyó a todos los pacientes entre 50 y 65 años sometidos a RVAo quirúrgico aislado en 27 centros durante 18 años. Analizamos la supervivencia observada y esperada a los 18 años de pacientes con EAoG de bajo gradiente con FEVI conservada y todos los otros tipos de EAoG. Mediante emparejamiento basado en índice de propensión, comparamos la esperanza de vida de los pacientes con EAoG de bajo gradiente con FEVI conservada vs EAoG de alto gradiente con FEVI conservada. Resultados: Se analizó a 5.084 pacientes, 413 con EAoG de bajo gradiente con FEVI conservada. En estos pacientes, la supervivencia observada a 10, 15 y 18 años fue 86,6% (IC95%, 85,3-87,8), 75% (IC95%, 72,7-77,2) y 63,5% (IC95%, 58,8-67,8). La supervivencia esperada a 10, 15 y 18 años fue 90,2%, 82,1% y 75,7%. En la muestra emparejada, la supervivencia de los pacientes con EAoG de bajo gradiente con FEVI conservada fue similar a la de aquellos con EAoG de alto gradiente con FEVI conservada, test de log-rank p=0,95, HR=1 (IC95%, 0,7–1,4; p=0,95). Conclusiones: Existe una pérdida en la esperanza de vida en todos los tipos de EAoG después del RVAo. Esta pérdida es mayor en los pacientes con disfunción ventricular y menor en los pacientes con EAoG de bajo gradiente o alto gradiente con FEVI conservada. El beneficio de la cirugía es similar entre estos 2 últimos grupos.(AU)

Introduction and objectives: Surgical aortic valve replacement (SAVR) can modify the natural history of severe aortic stenosis (SAS). However, compared with the general population, these patients have a loss of life expectancy. The life expectancy of patients who undergo SAVR due to low-gradient SAS with preserved left ventricular ejection fraction (LVEF) is unknown. Methods: We included all patients between 50 and 65 years who underwent isolated SAVR in 27 Spanish centers during an 18-year period. We analyzed observed and expected survival at 18 years in patients with low-gradient SAS with preserved LVEF and all other types of SAS. We used propensity score matching to compare the life expectancy of patients with low-gradient SAS with preserved LVEF vs those with high-gradient SAS with preserved LVEF. Results: We analyzed 5084 patients, of whom 413 had low-gradient SAS with preserved LVEF. For these patients, observed survival at 10, 15 and 18 years was 86.6% (95%CI, 85.3-87.8), 75% (95%CI, 72.7-77.2), and 63.5% (95%CI, 58.8-67.8). Expected survival at 10, 15 and 18 years was 90.2%, 82.1%, and 75.7%. In the matched sample, survival of patients with low-gradient SAS with preserved LVEF was similar to that of patients with high-gradient with preserved LVEF, log-rank test, P=.95; HR=1 (95%CI, 0.7–1.4; P=.95). Conclusions: There is a loss of life expectancy in patients with all types of SAS undergoing SAVR. This loss is higher in patients with left ventricular dysfunction and lower in patients with low-gradient or high-gradient aortic stenosis with preserved LVEF. The benefit of surgery is similar between these last 2 groups.(AU)

Life expectancy after surgical aortic valve replacement for low-gradient aortic stenosis with preserved ejection fraction.

INTRODUCTION AND OBJECTIVES: Surgical aortic valve replacement (SAVR) can modify the natural history of severe aortic stenosis (SAS). However, compared with the general population, these patients have a loss of life expectancy. The life expectancy of patients who undergo SAVR due to low-gradient SAS with preserved left ventricular ejection fraction (LVEF) is unknown. METHODS: We included all patients between 50 and 65 years who underwent isolated SAVR in 27 Spanish centers during an 18-year period. We analyzed observed and expected survival at 18 years in patients with low-gradient SAS with preserved LVEF and all other types of SAS. We used propensity score matching to compare the life expectancy of patients with low-gradient SAS with preserved LVEF vs those with high-gradient SAS with preserved LVEF. RESULTS: We analyzed 5084 patients, of whom 413 had low-gradient SAS with preserved LVEF. For these patients, observed survival at 10, 15 and 18 years was 86.6% (95%CI, 85.3-87.8), 75% (95%CI, 72.7-77.2), and 63.5% (95%CI, 58.8-67.8). Expected survival at 10, 15 and 18 years was 90.2%, 82.1%, and 75.7%. In the matched sample, survival of patients with low-gradient SAS with preserved LVEF was similar to that of patients with high-gradient with preserved LVEF, log-rank test, P=.95; HR=1 (95%CI, 0.7-1.4; P=.95). CONCLUSIONS: There is a loss of life expectancy in patients with all types of SAS undergoing SAVR. This loss is higher in patients with left ventricular dysfunction and lower in patients with low-gradient or high-gradient aortic stenosis with preserved LVEF. The benefit of surgery is similar between these last 2 groups.

Biological versus mechanical prostheses for aortic valve replacement.

OBJECTIVES: Long-term real-world outcomes are critical for informing decisions about biological (Bio) or mechanical (Mech) prostheses for aortic valve replacement, particularly in patients aged between 50 and 65 years. The objective was to compare long-term survival and major adverse cardiac and cardiovascular events (ie, stroke, reoperation, and major bleeding) within this population. METHODS: This was a multicenter observational study including all patients aged between 50 and 65 years who underwent an aortic valve replacement because of severe isolated aortic stenosis between the years 2000 and 2018. A total of 5215 patients from 27 Spanish hospitals were registered with a follow-up of 15 years. Multivariable analyses, including a 2:1 propensity score matching (1822 Mech and 911 Bio) and competing risks analyses were applied. RESULTS: Bio prostheses were implanted in 19% of patients (n = 992). No significant differences were observed between matched groups in long-term survival (hazard ratio [HR], 1.14; 95% confidence interval [CI], 0.88-1.47; P = .33). Stroke rates were higher for Mech prostheses, but not significant (HR, 0.72; 95% CI, 0.50-1.03; P = .07). Finally, higher rates of major bleeding were found in the Mech group (HR, 0.65; 95% CI, 0.49-0.87; P = .004), whereas reoperation was more frequent among the Bio group (HR, 3.04; 95% CI, 1.80-5.14; P < .001). Bio prostheses increased from 13% in the period from 2000 to 2008 to 24% in 2009 to 2018. CONCLUSIONS: Long-term survival was comparable among groups in patients between 50 and 65 years of age. Mech prostheses were associated with a higher risk of major bleeding, whereas Bio prostheses entailed higher reoperation rates. Bio prostheses seem a reasonable choice for patients between 50 and 65 years in Spain.

Life expectancy after aortic valve replacement in young patients.

INTRODUCTION AND OBJECTIVES: In young patients with severe aortic stenosis, it is unknown whether their life expectancy restored after aortic valve replacement (AVR) is unknown. METHODS: We analyzed all patients aged between 50 and 65 years who underwent isolated AVR in 27 Spanish centers during an 18-year period. We compared observed and expected survival at 15 years of follow-up. We repeated all analyses for patients without complications in the postoperative period. RESULTS: A total of 5084 patients were analyzed. For the overall sample, observed survival at 10 and 15 years was 85.3% (95%CI, 84.1%-86.4%) and 73.7% (95%CI, 71.6%-75.6%), respectively. Expected survival was 90.1% and 82.1%. Cumulative relative survival for 1, 5, 10 and 15 years of follow-up was 97.4% (95%CI, 96.9%-97.9%), 96.5% (95%CI, 95.7%-97.3%), 94.7% (95%CI, 93.3%-95.9%), and 89.8% (95%CI, 87.3%-92.1%). For patients without complications, cumulative relative survival for 1, 5, 10 and 15 years was 100.3% (95%CI, 99.8%-100.5%), 98.9% (95%CI 97.6% -99.9%), 97.3% (95%CI, 94.9%-99.4%), and 91.9% (95%CI, 86.5%-96.8%). CONCLUSIONS: Life expectancy in young patients who have severe aortic stenosis and undergo AVR is lower than that of the general population. Life expectancy of individuals without complications during the postoperative period is also reduced. Therefore, baseline characteristics are likely the main factors that explain the reduction in life expectancy.

Differences in life expectancy between men and women after aortic valve replacement.

OBJECTIVES: Some researchers have observed an increased number of deaths during the follow-up of young patients who undergo aortic valve replacement due to severe aortic stenosis, suggesting that this procedure does not restore their life expectancy. Our goal was to confirm these findings and explore sex-based differences. METHODS: All patients between 50 and 65 years of age who underwent isolated aortic valve replacement in 27 Spanish centres during an 18-year period were included. We compared observed and expected survival at 15 years of follow-up and estimated the cumulative incidence of death from a competing risks point of view. We stratified by sex and analysed if being a woman was an independent risk factor for death. RESULTS: For men, the observed survival at 10 and 15 years of follow-up was 85% [95% confidence interval (CI) 83.6%-86.4%] and 72.3% (95% CI 69.7%-74.7%), respectively whereas the expected survival was 88.1% and 78.8%. For women, the observed survival at 10 and 15 years was 85% (95% CI 82.8%-86.9%) and 73% (95% CI 69.1%-76.4%), whereas the expected survival was 94.6% and 89.4%. At 15 years of follow-up, the cumulative incidence of death due to the disease in men and women was 8.2% and 16.7%, respectively. In addition, being a woman was an independent risk factor for death (hazard ratio = 1.23 (95% CI 1.02-1.48; P = 0.03). CONCLUSIONS: After the aortic valve replacement, men and women do not have their life expectancy restored, but this loss is much higher in women than in men. In addition, being a woman is a risk factor for long-term death. Reasons for these findings are unknown and must be investigated.

Biological or mechanical prostheses for isolated aortic valve replacement in patients aged 50-65 years: the ANDALVALVE study.

OBJECTIVES: The decision about whether to use a biological or a mechanical prosthesis for aortic valve replacement remains controversial in patients between 50 and 65 years of age and has yet to be addressed in a Mediterranean population. This research aimed to analyse long-term survival and major morbidity rates (30-day mortality, stroke, any prosthetic reoperation and major bleeding) within this population. METHODS: Our multicentre observational retrospective study included all subjects aged 50-65 years who had a primary isolated aortic valve replacement due to severe aortic stenosis at 7 public hospitals from Andalusia (Spain) between 2000 and 2015. Concomitant surgery, reoperations and endocarditis were the exclusion criteria. A total of 1443 patients were enrolled in the study (272 with biological and 1171 with mechanical valves). Multivariate analyses including a 2:1 propensity score matching (506 mechanical and 257 biological prostheses) were conducted. RESULTS: Bioprostheses were implanted in 18.8% (n = 272): 35% were women; the mean EuroSCORE-I was 3%. The mean follow-up was 8.1 ± 4.9 years in a matched sample: 8.8 ± 4.9 years in those receiving a mechanical vs 7.1 ± 4.5 years in those receiving a biological prosthesis (P = 0.001). In the paired sample, the 15-year survival rate was 73% in those who had a biological vs 76% in those who had a mechanical valve [hazard ratio (HR) 0.80, 95% confidence interval (CI) 0.54-1.20; P = 0.159]. No significant differences were observed in patients ≥55 years old (74% of 15-year survival in both groups: HR 0.88, 95% CI 0.56-1.34; P = 0.527). A higher rate of major bleeding was found in patients with a mechanical prosthesis (P = 0.004), whereas reoperation was more frequent among those with a biological prosthesis (P = 0.01). CONCLUSIONS: Long-term survival was comparable in patients above 55 years of age. Mechanical prostheses were associated with more major bleeding and bioprostheses, with more reoperations. A bioprosthesis in patients above 55 years old is a reasonable choice. CLINICAL TRIAL REGISTRATION NUMBER: NCT03239509.