Centres of excellence in heart failure: results of an accreditation programme in Spain (2017-2021).

AIMS: To describe logistics and outcomes of the accreditation program of centres of excellence in heart failure (HF) developed in Spain by the Spanish Society of Cardiology (SEC) between 2016 and 2021. METHODS AND RESULTS: A scientific committee created by the SEC defined three types of HF units (community, specialized, and advanced), depending on the characteristics of the hospital and their portfolio of services and equipment, as well as the quality standards required for the accreditation of excellence. The units were required to submit to the SEC a document certifying compliance with the requirements and quality standards. Once verified these, the unit received accreditation of excellence from the SEC. Between 2017 and October 2021, 78 HF units spread throughout Spain applied for accreditation. This represents 50.6% of all Spanish national health system centres with cardiology departments. Accreditation was definitive in 56.4% of the applicant centres and provisional in the remaining 43.6%. Of the 78 units, 19 were community units, 44 specialized, and 15 advanced. Of the 34 units that received provisional accreditation for failure to meet any of the required quality standards, all resolved these deficits within 6 months of the initial evaluation, subsequently receiving definitive accreditation. CONCLUSIONS: Our experience indicates that implementation of an accreditation programme for excellence and quality of care of HF units at the national level by a scientific society is feasible and sustainable over time, leading the majority of HF units in the country to apply for accreditation and to meet the required quality standards.

Sobrecarga oral de glucosa como herramienta para la mejora tras intervencionismo coronario percutáneo / Oral glucose tolerance test as a tool for patient improvement after percutaneous coronary intervention

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Resequencing the whole MYH7 gene (including the intronic, promoter, and 3' UTR sequences) in hypertrophic cardiomyopathy.

MYH7 mutations are found in ~20% of hypertrophic cardiomyopathy (HCM) patients. Currently, mutational analysis is based on the sequencing of the coding exons and a few exon-flanking intronic nucleotides, resulting in omission of single-exon deletions and mutations in internal intronic, promoter, and 3' UTR regions. We amplified and sequenced large MYH7 fragments in 60 HCM patients without previously identified sarcomere mutations. Lack of aberrant PCR fragments excluded single-exon deletions in the patients. Instead, we identified several new rare intronic variants. An intron 26 single nucleotide insertion (-5 insC) was predicted to affect pre-mRNA splicing, but allele frequencies did not differ between patients and controls (n = 150). We found several rare promoter variants in the patients compared to controls, some of which were in binding sites for transcription factors and could thus affect gene expression. Only one rare 3' UTR variant (c.*29T>C) found in the patients was absent among the controls. This nucleotide change would not affect the binding of known microRNAs. Therefore, MYH7 mutations outside the coding exon sequences would be rarely found among HCM patients. However, changes in the promoter region could be linked to the risk of developing HCM. Further research to define the functional effect of these variants on gene expression is necessary to confirm the role of the MYH7 promoter in cardiac hypertrophy.

Transplantation for complex congenital heart disease in adults: a subanalysis of the Spanish Heart Transplant Registry.

BACKGROUND: Congenital heart diseases (CHDs) have high infant mortality in their severe forms. When adulthood is reached, a heart transplant (HTx) may be required. Spanish adult population transplanted for CHD was analyzed and compared with the most frequent causes of HTx and between different subgroups of CHD. MATERIALS AND METHODS: A total of 6048 patients (HTx 1984-2009) were included. Pediatric transplants (<15 yr), combined transplants, reHTx, and HTx for heart diseases other than idiopathic dilated cardiomyopathy (IDCM) and ischemic heart disease (IHD) were excluded. Total patients included: 3166 (IHD = 1888; IDCM = 1223; CHD = 55). Subgroups were studied as follows: (1) single ventricle with pulmonary stenosis (n = 18), (2) single ventricle with tricuspid atresia and Glenn/Fontan surgery (n = 10), (3) congenitally corrected transposition of the great vessels (TGV) or with switch atrial surgery (n = 10), and (4) CHD with right ventricle overload (n = 17). RESULTS: Survival probability was different between groups (p = 0.0001). Post hoc analysis showed some differences between groups (CHD vs. IHD, p = 0.05; CHD vs. IDCM, p = 0.5; IHD vs. IDCM, p = 0.0001). Early mortality was different between CHD subgroups (group 1 = 19%, group 2 = 40%, group 3 = 0%, group 4 = 29%; p < 0.001); however, overall mortality did not show differences between subgroups (p = 0.5). CONCLUSIONS: The percentage of Spanish adult HTx patients for CHD is low (1%). The survival curve is better than for other HTx causes (IHD). Nevertheless, early mortality was higher, particularly in some subgroups (Fontan).

Registro Español de Trasplante Cardiaco. XXI Informe Oficial de la Sección de Insuficiencia Cardiaca y Trasplante Cardiaco de la Sociedad Española de Cardiología (1984-2009) / Spanish Heart Transplantation Registry. 21st Official Report of the Spanish Society of Cardiology Working Group on Heart Failure and Heart Transplantation (1984-2009)

Introducción y objetivos. El propósito de este artículo es presentar los resultados del trasplante cardiaco desde que se inició esta modalidad terapéutica en España en mayo de 1984. Métodos. Se ha realizado un análisis descriptivo de todos los trasplantes cardiacos realizados hasta el 31 de diciembre de 2009. Resultados. El número total de trasplantes fue de 6.048. El perfil clínico medio del paciente que se trasplantó en España en 2009 fue el de un varón de 53 años, diagnosticado de cardiopatía isquémica no revascularizable con depresión grave de la función ventricular y situación funcional avanzada, al que se implantó un corazón procedente de un donante fallecido por hemorragia cerebral, con una media de edad de 37 años y un tiempo en lista de espera de 106 días. El tiempo medio de supervivencia se ha incrementado con los años. Así, mientras en el total de la serie la probabilidad de supervivencia tras 1, 5, 10 y 15 años es del 78, el 67, el 53 y el 40% respectivamente, en los últimos 5 años la probabilidad de supervivencia tras 1 y 5 años es del 85 y el 73% respectivamente. La causa más frecuente de fallecimiento es el fallo agudo del injerto (17%), seguido de infección (16%), un combinado de enfermedad vascular del injerto y muerte súbita (14%), tumores (12%) y rechazo agudo (8%). Conclusiones. La supervivencia obtenida en España con el trasplante cardiaco, sobre todo en los últimos años, lo sitúa como el tratamiento de elección para cardiopatías irreversibles en situación funcional avanzada y sin otras opciones médicas o quirúrgicas establecidas (AU)

Introduction and objectives. The purpose of this report is to present the results obtained with heart transplantation in Spain from the first use of this therapeutic modality in May 1984. Methods. A descriptive analysis of all heart transplantations performed up to December 31, 2009 is presented. Results. In total, 6048 transplants were carried out. The typical clinical profile of a Spanish heart transplant patient in 2009 was that of a 53-year-old male who had been diagnosed with nonrevascularizable ischemic heart disease and who had severely impaired ventricular function and a poor functional status. The implanted heart typically came from a donor who had died from a brain hemorrhage (mean age 37 years) and the average time on the waiting list was 106 days. Mean survival time has increased progressively over the years. Whereas for the whole time series, the probability of survival at 1, 5, 10 and 15 years was 78%, 67%, 53% and 40%, respectively, for the past 5 years, the probability of survival at 1 and 5 years was 85% and 73%, respectively. The most frequent cause of death was acute graft failure (17%), followed by infection (16%), the combination of graft vascular disease and sudden death (14%), tumor (12%) and acute rejection (8%). Conclusions. The survival rates obtained in Spain with heart transplantation, especially in recent years, make the procedure the treatment of choice for patients who have irreversible heart failure and a poor functional status and for whom there are few other established medical or surgical options (AU)

Clinical recommendations for the use of everolimus in heart transplantation.

Proliferation signal inhibitors (PSIs), everolimus (EVL), and sirolimus are a group of immunosuppressor agents indicated for the prevention of acute rejection in adult heart transplant recipients. Proliferation signal inhibitors have a mechanism of action with both immunosuppressive and antiproliferative effects, representing an especially interesting treatment option for the prevention and management of some specific conditions in heart transplant population, such as graft vasculopathy or malignancies. Proliferation signal inhibitors have been observed to work synergistically with calcineurin inhibitors (CNIs). Data from clinical trials and from the growing clinical experience show that when administered concomitantly with CNIs, PSIs allow significant dose reductions of the latter without loss of efficacy, a fact that has been associated with stabilization or significant improvement in renal function in patients with CNI-induced nephrotoxicity. The purpose of this article was to review the current knowledge of the role of PSIs in heart transplantation to provide recommendations for the proper use of EVL in cardiac transplant recipients, including indications, treatment regimens, monitoring, and management of the adverse events.

Clinical utility of NT-proBNP levels in late heart transplantation patients.

BACKGROUND: The present work was aimed to describe NT-proBNP levels in heart transplant patients after the first year postsurgery. METHODS: NT-proBNP concentration was measured in 1231 samples from 142 patients when a routine four-month follow-up was carried out, including other biochemical and clinical examinations. Endomyocardial biopsies were performed only upon clinical suspicion of acute rejection. RESULTS: NT-proBNP concentrations were not significantly correlated to post-transplantation time, though differences were observed according to clinical symptoms (Kruskal-Wallis test, p<0.001). Although multivariate analysis revealed statistically significant association between NT-proBNP concentration and some qualitative (cardiac allograft vasculopathy-CAV-, sex, diabetes) and quantitative (creatinine, hematocrit, age) variables, only moderately relevant contribution was observed for creatinine and CAV. Patients with rejection showed noticeable increases in serum NT-proBNP concentrations, above more than 2.5 times the reference change value (97%). NT-proBNP concentrations higher than 1000ng/L increased in 3.5 times (95%CI: 2.4-5) the risk of death in less than one year. CONCLUSIONS: After the first year from surgery, NT-proBNP concentrations were not associated to post-transplantation time and NT-proBNP could be a useful diagnostic marker for rejection, whenever serial measurements are made. A NT-proBNP cutoff value of 1000ng/L was identified for classifying patients at risk of death after one year.

Conferencia de Consenso de los Grupos Españoles de Trasplante Cardiaco / Spanish Heart Transplant Units Consensus Conference

La Sección de Insuficiencia Cardiaca, Trasplante Cardiaco y otras Alternativas Terapéuticas de la Sociedad Española de Cardiología desarrolló en Sevilla, en junio de 2005, una Conferencia de Consenso sobre trasplante cardiaco (TC) a la que fueron invitados a participar todos los grupos españoles de TC. El objetivo fue determinar, discutir y consensuar los aspectos más relevantes y/o controvertidos de diferentes áreas del TC en la actualidad: organización, selección del receptor, donantes, rechazo, inmunosupresión, enfermedad vascular del injerto, complicaciones a largo plazo y TC pediátrico. Este documento reúne las recomendaciones del grupo de trabajo incluyendo el grado de evidencia con que se respalda cada una (AU)

The Spanish Society of Cardiology’s working group on heart failure, heart transplantation and associated therapies organized a consensus conference on heart transplantation that was held in Seville, Spain in June 2005 and to which all Spanish heart transplant teams were invited. The aim was to evaluate, discuss and reach a consensus on the most important and controversial topics in different areas of heart transplantation today: organization, recipient selection, donors, rejection, immunosuppression, allograft vasculopathy, long-term complications, and pediatric heart transplantation. This report summarizes the working group’s recommendations, and reports the level of evidence supporting each recommendation (AU)

A randomized multicenter comparison of basiliximab and muromonab (OKT3) in heart transplantation: SIMCOR study.

BACKGROUND: Antilymphocytic antibodies have been long used for the prevention of acute rejection early after heart transplantation (HTx), but their adverse effects have limited their widespread use. Our aim was to evaluate the safety, tolerability, and efficacy of the novel anti-CD25 antibody basiliximab (BAS) compared with muromonab (OKT3). PATIENTS AND METHODS: In this multicenter study, 99 patients were randomly assigned to receive either BAS or OKT3 in the early post-HTx period. The primary endpoint was safety and tolerability. Specific safety variables were predefined for a better comparison of adverse effects. Secondary endpoints concerning anti-rejection efficacy were also evaluated. RESULTS: No adverse events related to study medication were found in the BAS group, whereas 23 were observed among patients receiving OKT3 (P<0.0001). The proportion of patients with predefined adverse events day 4 post-HTx was much higher with OKT3 than with BAS (43% vs. 4%; P<0.0001). Fever, acute pulmonary edema, hypotension, and other complications accounted for most of the difference. At 1-year follow-up, biopsy-proven rejection episodes grade>or=3A had occurred in 39.6% of BAS patients versus 40.4% of OKT3 patients (P=0.87). There were no differences in terms of severity and timing of acute rejection episodes. The number of infectious episodes, complications not related to study medication, and actuarial survival were similar in both groups. CONCLUSION: In this HTx study, induction therapy with BAS was safer and better tolerated than OKT3, without significant differences in efficacy outcomes.

[Myocardial Infarction Registry in Asturias: the RIMAS project]. / Registro del Infarto de Miocardio en Asturias: proyecto RIMAS.

BACKGROUND AND OBJECTIVE: Spanish hospital registers of myocardial infarction (MI) are not uniform. The RIMAS project is trying to know the real situation of myocardial infarction in Asturias and to observe possible differences among hospitals and with other registers. PATIENTS AND METHOD: It was a cohorts study using a hospital registry of patients with MI. All cases arriving alive to all public and private-public Asturian hospitals during 1998 were included. Demographic data, cardiovascular risk factors, delays, evolution, treatments and techniques used, were all registered. RESULTS: 875 cases were registered with a coverage rate of 77%. The average age was 66.5 years (45.6% older than 70 years) and women represented 29.1%. Sixty three per cent of the patients had tobacco consumption, 43% had arterial hypertension, and 22.3% were diabetics. The extrahospital delay was 135 min and thrombolysis delay was 180 min. Thrombolytic therapy was administered to 34.1% of patients and 4% were treated with primary angioplasty. Intrahospital mortality was 14.4%. At discharge, antiagregant therapy was administrated to 94%, betablockers to 43.2%, ACE inhibitors to 33.3% and hypolipemiants to 25% of treated patients. CONCLUSIONS: People attended in Asturias with a MI are older and there is a higher percentage of women. There are delays which include the start of thrombolytic therapy. However, there are significant differences with regard to the adhesion to clinical practice guidelines between different hospitals.

Assay of cytomegalovirus susceptibility to ganciclovir in renal and heart transplant recipients.

Ganciclovir (GCV) prophylaxis or pre-emptive therapy significantly reduce the rate of cytomegalovirus (CMV) disease and viremia, but increase the potential for emergence of ganciclovir-resistant CMV strains. The inhibitor concentration at 50% (IC(50)) of GCV from 156 CMV isolates from 59 renal or heart transplant recipients was calculated by means of a rapid phenotypic susceptibility assay. Twenty-seven strains were from 14 patients undergoing GCV therapy. The IC(50) was higher in patients under the prophylaxis regimen. One CMV strain, from a heart transplant recipient, became GCV-resistant after 1 month of therapy (IC(50)=13.7 micromol/l). These data, together with clinical and virological markers, suggested that a switch to foscarnet was necessary, and good evolution was observed. Thus, assay of CMV susceptibility to GCV could be helpful in clinical management.