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Hereditary haemorrhagic telangiectasia (HHT) (Osler-Weber-Rendu Syndrome) is an inherited vascular disorder, associated with arteriovenous malformations and bleeding events. Despite potential benefits, data regarding the use of left atrial appendage occlusion (LAAO) in HHT patients with non-valvular atrial fibrillation (NVAF) is scarce. The aim of the present paper was to assess the outcomes of HHT patients undergoing LAAO.This multicentre observational study included all consecutive patients with NVAF and a previous diagnosis of HHT who underwent LAAO between 2015 and December 2020. The follow-up protocol included a clinical control at 3 months after hospital discharge, and then yearly.Overall, 822 subjects undergoing LAAO were initially screened for the study. Among them, 7 patients had previous diagnosis of HHT. Device implant success was achieved in all patients and non-procedural adverse event were observed. At the maximum follow-up (median follow up = 470.5 days), no ischemic strokes or device related thrombosis (DRT) were reported. Absence of antithrombotic treatment after LAAO was not associated with an increased risk of stroke or DRT.LAAO might represent a promising non-pharmacological alternative to prevent thromboembolic events in patients with HHT and NVAF.

RESUMEN En las últimas dos décadas han tenido lugar grandes avances en el campo de la cardiología intervencionista. Estos incluyen no solo nuevas técnicas y tratamientos, sino también cambios en la organización, como la atención continuada al infarto agudo de miocardio y la aparición de salas tuteladas. Todos estos avances hacen necesaria una actualización de los requisitos y del equipamiento necesarios en una unidad de hemodinámica y cardiología intervencionista. En este documento de consenso de la Asociación de Cardiología Intervencionista de la Sociedad Española de Cardiología, la Asociación de Cardiopatía Isquémica y Cuidados Agudos Cardiovasculares de la Sociedad Española de Cardiología, y la Asociación Española de Enfermería en Cardiología, se establecen las recomendaciones que deberían cumplir los centros hospitalarios donde esté instalada o se pretenda instalar una unidad de hemodinámica y cardiología intervencionista, los requisitos de dotación y cualificación de profesionales, las dotaciones tecnológicas y los materiales necesarios, y aspectos relacionados con las salas tuteladas y los programas de tratamiento de la cardiopatía estructural.

Over the last two decades, several key advances have been made in the field of interventional cardiology including new techniques and treatments, organizational changes such as the management of acute myocardial infarction, and the arrival of satellite catheterization laboratories. All these advances require the updating of the requirements and equipment that are needed in an interventional cardiology unit. This consensus document by the Interventional Cardiology Association of the Spanish Society of Cardiology, the Ischemic Heart Disease and Acute Cardiac Care Association of the Spanish Society of Cardiology and the Spanish Association of Nursing in Cardiology which describes the recommendations that should be followed by percutaneous coronary intervention capable hospitals or centers intend to build interventional cardiology units. It also describes the requirements for provision, qualification of professionals, technological and material resource allocation, and aspects related to supervised catheterization laboratories and structural heart disease programs.

Background The Watchman FLX is a device upgrade of the Watchman 2.5 that incorporates several design enhancements intended to simplify left atrial appendage occlusion (LAAO) and improve procedural outcomes. This study compares peri-procedural results of LAAO with Watchman FLX (Boston Scientific, Marlborough, Massachusetts) in centers with varying degrees of experience with the Watchman 2.5 and Watchman FLX. Methods Prospective, multicenter, “real-world” registry including consecutive patients undergoing LAAO with the Watchman FLX at 26 Spanish sites (FLX-SPA registry). Implanting centers were classified according to the center’s prior experience with the Watchman 2.5. A further division of centers according to whether or not they had performed ≤ 10 or > 10Watchman FLX implants was prespecified at the beginning of the study. Procedural outcomes of institutions stratified according to their experience with the Watchman 2.5 and FLX devices were compared. Results 359 patients [mean age 75.5 (SD8.1), CHA2DS2-VASc 4.4 (SD1.4), HAS-BLED 3.8(SD0.9)] were included. Global success rate was 98.6%, successful LAAO with the first selected device size was achieved in 95.5% patients and the device was implanted at first attempt in 78.6% cases. There were only 9(2.5%) major peri-procedural complications. No differences in efficacy or safety results according to the centeŕs previous experience with Watchman 2.5 and procedural volume with Watchman FLX existed. Conclusions The Watchman FLX attains high procedural success rates with complete LAA sealing in unselected, real-world patients, along with a low incidence of peri-procedural complications, regardless of operatoŕs experience with its previous device iteration or the number of Watchman FLX devices implanted.

Dr. I. Cruz-González is proctor for Lifetech Scientific [Shenzhen] Co., China and was funded by ISCIII (PI19/00658), co-funded by ERDF, “A way to make Europe” and Gerencia Regional Salud de CyL (GRS 3031/A/19). Dr. A. Pérez de Prado is proctor for and has received Research grants from Boston Scientific [Marlborough, Massachusetts, US]. Dr R. Estévez-Loureiro and Dr. JM. Ruiz-Nodar are proctors for Boston Scientific [Marlborough, Massachusetts, US]. No other disclosures exist., Background: The Watchman FLX is a device upgrade of the Watchman 2.5 that incorporates several design enhancements intended to simplify left atrial appendage occlusion (LAAO) and improve procedural outcomes. This study compares peri-procedural results of LAAO with Watchman FLX (Boston Scientific, Marlborough, Massachusetts) in centers with varying degrees of experience with the Watchman 2.5 and Watchman FLX. Methods: Prospective, multicenter, “real-world” registry including consecutive patients undergoing LAAO with the Watchman FLX at 26 Spanish sites (FLX-SPA registry). Implanting centers were classified according to the center's prior experience with the Watchman 2.5. A further division of centers according to whether or not they had performed ≤ 10 or > 10Watchman FLX implants was prespecified at the beginning of the study. Procedural outcomes of institutions stratified according to their experience with the Watchman 2.5 and FLX devices were compared. Results: 359 patients [mean age 75.5 (SD8.1), CHA2DS2-VASc 4.4 (SD1.4), HAS-BLED 3.8(SD0.9)] were included. Global success rate was 98.6%, successful LAAO with the first selected device size was achieved in 95.5% patients and the device was implanted at first attempt in 78.6% cases. There were only 9(2.5%) major peri-procedural complications. No differences in efficacy or safety results according to the centeŕs previous experience with Watchman 2.5 and procedural volume with Watchman FLX existed. Conclusions: The Watchman FLX attains high procedural success rates with complete LAA sealing in unselected, real-world patients, along with a low incidence of peri-procedural complications, regardless of operatoŕs experience with its previous device iteration or the number of Watchman FLX devices implanted., Gerencia Regional Salud de CyL GRS 3031/A/19, Boston Scientific Corporation, European Regional Development Fund, Instituto de Salud Carlos III PI19/00658

Introduction and objectives The COVID-19 outbreak has had an unclear impact on the treatment and outcomes of patients with ST-segment elevation myocardial infarction (STEMI). The aim of this study was to assess changes in STEMI management during the COVID-19 outbreak. Methods Using a multicenter, nationwide, retrospective, observational registry of consecutive patients who were managed in 75 specific STEMI care centers in Spain, we compared patient and procedural characteristics and in-hospital outcomes in 2 different cohorts with 30-day follow-up according to whether the patients had been treated before or after COVID-19. Results Suspected STEMI patients treated in STEMI networks decreased by 27.6% and patients with confirmed STEMI fell from 1305 to 1009 (22.7%). There were no differences in reperfusion strategy (> 94% treated with primary percutaneous coronary intervention in both cohorts). Patients treated with primary percutaneous coronary intervention during the COVID-19 outbreak had a longer ischemic time (233 [150-375] vs 200 [140-332] minutes, P

Objectives This study sought to compare the long-term safety and efficacy of drug-eluting balloons (DEB) and everolimus-eluting stents (EES) in patients with in-stent restenosis (ISR) of drug-eluting stents (DES). Background Treatment of patients with DES-ISR remains a challenge. Methods The RIBS IV (Restenosis Intra-Stent of Drug-Eluting Stents: Drug-Eluting Balloons vs Everolimus-Eluting Stents) trial is a prospective multicenter randomized clinical trial comparing DEB and EES in patients with DES-ISR. The pre-specified comparison of the 3-year clinical outcomes obtained with these interventions is the main objective of the present study. Results A total of 309 patients with DES-ISR were randomized to DEB (n = 154) or EES (n = 155). At angiographic follow-up, the in-segment minimal lumen diameter was larger in the EES arm (2.03 ± 0.7 mm vs. 1.80 ± 0.6 mm; p 1 year) target lesion revascularization (2.6% vs. 4%) and target vessel revascularization (4% vs. 6.6%) was similar in the 2 arms. Rates of cardiac death (3.9% vs. 3.2%), myocardial infarction (2.6% vs. 4.5%), and stent thrombosis (1.3% vs. 2.6%) at 3 years were also similar in both arms. Conclusions The 3-year clinical follow-up of this randomized clinical trial demonstrates that in patients with DES-ISR, EES reduce the need for repeat interventions compared with DEB. (Restenosis Intra-Stent of Drug-Eluting Stents: Drug-Eluting Balloons vs Everolimus-Eluting Stents [RIBS IV]; NCT01239940)

Resumen Introduccion y objetivos La fibrilacion auricular (FA) es un conocido factor de riesgo de mortalidad en diferentes patologias. Sin embargo, los datos publicados en insuficiencia cardiaca descompensada (ICD) son contradictorios. El objetivo es investigar el impacto en la mortalidad de la FA en pacientes ingresados por ICD, comparativamente con otras causas. Metodos Estudio retrospectivo de cohortes, en el que durante 10 anos se recluto a todos los pacientes que ingresaron por ICD, infarto agudo de miocardio (IAM) y accidente cerebrovascular (ACV), con una mediana de seguimiento de 6,2 anos. Resultados Se recluto a 6.613 pacientes (74 ± 11 anos; 54,6% varones); 2.177 con IAM, 2.208 con ICD y 2.228 con ACV. La mortalidad cruda tras el alta de los pacientes con FA e IAM (razon de tasas de incidencia, 2,48; p Conclusiones La FA se comporta como factor de riesgo independiente de mortalidad tras el alta en pacientes con un ingreso previo por IAM y ACV, no asi para aquellos con ICD.

AIMS: The aim of this study was to observe the percentage of thromboembolic and haemorrhagic events over a 2-year follow-up in patients with non-valvular atrial fibrillation (NVAF) undergoing closure of the left atrial appendage (LAA) with an occlusion device. Observed events and CHADS2 (congestive heart failure, hypertension, age, diabetes, stroke history), CHA2DS2-VASc (also adding: vascular disease and sex) and HAS-BLED (hypertension, abnormal liver/renal function, stroke history, bleeding predisposition, labile international normalised ratios, elderly, drugs/alcohol use)-predicted events were compared. METHODS: LAA closure with an occlusion device was performed in 167 NVAF patients contraindicated for oral anticoagulants and recruited from 12 hospitals between 2009 and 2013. At least two transoesophageal echocardiograms were performed in the first 6 months postimplantation. Antithrombotics included clopidogrel and aspirin. Patients were monitored for death, stroke, major and relevant bleeding and hospitalisation for concomitant conditions. Mean age was 74.68±8.58, median follow-up was 24 months, 5.38% had intraoperative complications and implantation was successful in 94.6% of subjects. Mortality during follow-up was 10.8%, mostly (9.5%) non-cardiac related. Bleeding occurred in 10.1% of subjects, 5.7% major and 4.4% minor though relevant, and 4.4% suffered stroke. Major bleeding and stroke/transient ischaemic attack events within 2 years (annual event rates, 290 patients/year) were less frequent than expected from CHADS2 (2.4% vs 9.6%), CHA2DS2-VASc (2.4% vs 8.3%) and HAS-BLED (3.1% vs 6.6%) risk scores (p

Atrial fibrillation (AF) is an independent risk factor for mortality in several diseases. However, data published in acute decompensated heart failure (DHF) are contradictory. Our objective was to investigate the impact of AF on mortality in patients admitted to hospital for DHF compared with those admitted for other reasons.This retrospective cohort study included all patients admitted to hospital within a 10-year period due to DHF, acute myocardial infarction (AMI), or ischemic stroke (IS), with a median follow-up of 6.2 years.We included 6613 patients (74 ± 11 years; 54.6% male); 2177 with AMI, 2208 with DHF, and 2228 with IS. Crude postdischarge mortality was higher in patients with AF hospitalized for AMI (incident rate ratio, 2.48; P.001) and IS (incident rate ratio, 1.84; P.001) than in those without AF. No differences were found in patients with DHF (incident rate ratio, 0.90; P = .12). In adjusted models, AF was not an independent predictor of in-hospital mortality by clinical diagnosis. However, AF emerged as an independent predictor of postdischarge mortality in patients with AMI (HR, 1.494; P = .001) and IS (HR, 1.426; P.001), but not in patients admitted for DHF (HR, 0.964; P = .603).AF was as an independent risk factor for postdischarge mortality in patients admitted to hospital for AMI and IS but not in those admitted for DHF.

Treatment of patients with drug-eluting stent (DES) in-stent restenosis (ISR) is particularly challenging. We sought to compare results of drug-eluting balloons in patients with DES-ISR with those in patients with bare-metal stent (BMS) ISR. A pooled analysis of the Restenosis Intra-Stent: Drug-Eluting Balloon versus Everolimus-Eluting Stent IV and V randomized trials was performed. Both trials had identical inclusion and exclusion criteria. Results of drug-eluting balloons in 95 patients with BMS-ISR and 154 patients with DES-ISR were compared. Patients with DES-ISR were more frequently diabetics, presented more often as an acute coronary syndrome and had more severe lesions and more frequently a focal pattern, including edge-ISR. Late angiographic findings (92% of eligible patients), including minimal lumen diameter (1.80 ± 0.6 vs 2.01 ± 0.6 mm, p = 0.001; absolute mean difference 0.21 mm; 95% confidence interval 0.04 to 0.38; p = 0.014) and restenosis rate (19% vs 9.5%, p

The complexity of the individual patient and organization of medical practice results in important institutional and country quality of care variability.1–17 Attempts to assess the quality of clinical practice have established rating systems that may yield completely different results and rating for the same hospital during the same period of time, adding confusion rather than help to prove their usefulness and, questioning whether existing measures can actually measure quality.18–35 Most important, benchmarking may be associated with progressive improvement both in performance and outcomes,18,26,28,36–38 highlighting the relevance of standardization of quality measures and the responsibility of scientific societies. The Spanish Society of Cardiology (SSC) and the Spanish Society of Thoracic and Cardiovascular Surgery (SSTCS) organized a task force to identify and define two sets of quality metrics in hospital cardiology practice: (i) outcome measures (metrics of the final quality of the practice of cardiology) and (ii) performance measures (metrics of clinical practice which are known to positively influence desirable outcomes). Beyond this objective, Scientific Societies and Health Care Authorities should be responsible for the implementation of programmes to measure quality, ensure the quality of the data, benchmarking, and certification/accreditation of cardiology services. All European Society of Cardiology (ESC)32 and American Heart Association/American College of Cardiology33 guidelines were reviewed and recommendations related to quality standards were included in the document. ### Grading of quality markers Three levels were established both for class recommendation and level of evidence considering (i) clinical and practical …

Fundamento y objetivo El dolor toracico agudo (DTA) es un sintoma inespecifico que puede ser expresion de cardiopatia isquemica (CI). La arteriosclerosis frecuentemente esta presente en mas de un territorio vascular. El indice tobillo-brazo (ITB) es una herramienta util en el diagnostico de enfermedad arterial periferica (EAP). Nuestro objetivo fue evaluar la utilidad del ITB en pacientes con DTA en los que se sospecha CI. Pacientes y metodo Estudio transversal de 94 pacientes consecutivos, con una edad media (DE) de 57,4 (12,2) anos, ingresados por DTA con sospecha de CI, en los que se determino el ITB y se investigo la presencia de CI. Resultados La CI estuvo presente en 22 pacientes (23,4%) y estuvo ausente en 72 pacientes (76,6%). La EAP asintomatica (ITB=0,9) estuvo presente en 6 pacientes (27,2%) en el grupo con CI y en 7 pacientes (9,7%) en el grupo sin CI. Encontramos diferencias significativas en el ITB segun la presencia o no de CI (0,9 [0,23] frente a 1,17 [0,15]; p

Percutaneous intervention of a coronary graft is the treatment of choice when the graft fails. The objective is to report the long-term results of drug-eluting stents (DES) in mammary artery grafts (MAG). Patients who had been treated with DES for MAG in 27 centers were selected. The baseline and procedural clinical data were included prospectively, and the follow-up was performed with the patients, families, and medical records. Two hundred and sixty-eight patients were included: age 65.5 ± 10.1 years, diabetes 47.8%, ejection fraction 55.5 ± 14.9%. Indication: stable angina 28.4%, unstable angina 38.1%, non–ST-elevation myocardial infarction 21.6%, ST-elevation myocardial infarction 5.3%, and heart failure 6.7%; 1.19 ± 0.59 stents/patient were implanted measuring 18.8 ± 8.8 mm in length and 2.68 ± 0.35 mm in diameter. Rapamycin was used in 78 cases (29.1%), paclitaxel in 77 (28.7%), everolimus in 70 (26.1%), zotarolimus in 34 (12.7%), and biolimus in 9 (3.4%). All cases were successful except for 1 in which the patient died 30 minutes after the procedure. There were no other inhospital events. After a follow-up of 41 months (Q 25 : 23.7 to Q 75 : 57.8), 24 patients (9%) died of heart-related causes and 20 (7.5%) of noncardiac causes. Repeat revascularization was necessary in 31 cases, and in 1 additional patient, there was total occlusion, which was not treated. These 32 patients represented 11.9% of the total. In conclusion, the implantation of DES in MAG shows very high procedural success and also low long-term event rates.

The adequate device size selection for left atrial appendage closure is crucial to ensuring adequate implantation and for avoiding the need for multiple attempts that increase the risk of complications. Our aim was to evaluate the information obtained using different imaging techniques to select the size of the closure device in a clinical environment.Thirty-seven patients who consecutively underwent implantation of Amplatzer cardiac plug (ACP) devices were studied. All patients were examined using computed tomography (CT) prior to intervention. Measurements were compared to those obtained using intraoperative transesophageal echocardiography (IOTEE) and angiography. Size was determined by the longest axis of the appendage ostium. The influence of all techniques on the correct selection of final size was assessed.The measurements taken using the three techniques agreed in only 21.6% of the cases, leading to accurate selection of device size. Two techniques coincided as follows: IOTEE-CT in 45.9%, angiography-CT in 35.13%, and angiography-IOTEE in 24.3%. Measurements using CT were definitive for ACP selection in 75.7% of cases, angiography in 48.6%, and echocardiography in 51.4%. Device size was undermeasured with angiography in 35.1% of cases, and with IOTEE in 24.3%; CT overmeasured 21.6% of cases. The combination of angiography-CT was the most accurate for selection of device size.CT most often predicts the appropriate device size. If it fails, it usually overestimates the size. Agreement of measurements with all three techniques is the most accurate situation; when two agree, the most accurate combination is angiography and CT.

Aims: Paclitaxel drug-eluting balloons (pDEB) could be an attractive option to minimise side branch (SB) restenosis in bifurcated coronary lesions. We compared angiographic and clinical outcomes with pDEB plus bare metal stent (BMS) versus drug-eluting stents (DES) in de novo bifurcated lesions. Methods and results: This multicentre randomised trial included 108 patients. Sequential main branch (MB)/SB dilatation with pDEB, with provisional T-stenting with BMS in the MB was performed in the pDEB group, and with everolimus DES in the DES group. The primary endpoint was late lumen loss (LLL) at nine months. The secondary endpoint was the incidence of major adverse cardiac events (MACE: death, myocardial infarction, or target lesion revascularisation). In-segment MB LLL was 0.31±0.48 mm in the pDEB group, and 0.16±0.38 mm in the DES group (p=0.15); mean difference was 0.15 mm (upper limit one-sided 95% CI: 0.27 mm; p=0.001; non-inferiority test). LLL in SB was –0.04±0.76 mm in the pDEB group and –0.03±0.51 mm in the DES group (p=0.983). MACE and TLR were higher in the pDEB group (17.3% vs. 7.1%; p=0.105, and 15.4% vs. 3.6%; p=0.045), due to higher MB restenosis (13.5% vs. 1.8%; p=0.027). Conclusions: pDEB bifurcation pretreatment with BMS implantation in MB showed greater LLL (ns) and increased incidence of MACE compared to everolimus DES. Both strategies showed similar results in the SB.

Introduccion y objetivo La inversion precoz de las ondas T en pacientes con infarto agudo de miocardio ha sido recientemente relacionada con una mejor funcion ventricular y una evolucion mas favorable, al contrario de lo que sucede en la angina inestable. No se conoce en cambio el significado de las ondas T negativas profundas que aparecen en ocasiones en la fase aguda de algunos infartos agudos de miocardio. El objetivo de este estudio es valorar su relacion con el dano miocardico existente y la extension de la enfermedad coronaria subyacente en los infartos agudos de miocardio anteriores con onda Q. Metodos Se analizaron a 48 pacientes con un primer infarto agudo de miocardio anterior con onda Q, con o sin trombolisis, ingresados con una evolucion menor de 24 h y que tenian realizada una coronariografia. Se definio como onda T negativa gigante aquella que tenia 8 mm o mas desde la linea base. Resultados De los 48 pacientes, 17 presentaban ondas T negativas gigantes (grupo T ) y 31 no (grupo N). En el grupo T, el tamano de la onda T negativa era de 11,29 ± 2,86 mm y el numero de derivaciones precordiales con ondas T negativas era de 4,35 ± 1,57. No hubo diferencias entre ambos grupos en variables como el sexo, factores de riesgo y otras caracteristicas basales. Los pacientes del grupo T eran mas jovenes, tenian menores niveles maximos de enzimas cardiacas y presentaron, asimismo, mayor recuperacion de ondas R durante el seguimiento, con diferencias significativas respecto al grupo N. La fraccion de eyeccion era mayor (56,3 ± 13,4 frente a 42 ± 12%; p I mientras que esta situacion ocurrio en el 38,7% de los pacientes del grupo N. Conclusiones La aparicion de ondas T negativas gigantes en la fase aguda o precoz de un infarto agudo de miocardio anterior con onda Q se asocia a un menor tamano del infarto, un menor deterioro funcional y una menor extension de la enfermedad coronaria subyacente.

Introduccion y objetivos La trombosis subaguda y las complicaciones vasculares y hemorragicas secundarias a los intensos regimenes de anticoagulacion seguidos hasta ahora tras la implantacion del stent intracoronario son los principales problemas del uso de este dispositivo. Estudiamos la incidencia de complicaciones relacionadas con el implante de un stent de Wiktor de forma electiva, en pacientes tratados con antiagregantes plaquetarios exclusivamente, asi como la incidencia de reestenosis clinica y angiografica a los 6 meses. Pacientes y metodos El estudio WINE es un estudio prospectivo, observacional y multicentrico en el que se incluyeron 368 pacientes (380 lesiones) de 11 hospitales espanoles. Todos los pacientes fueron tratados con aspirina (125-325 mg/dia) y ticlopidina (250 mg/12 h durante cuatro semanas). Tras el periodo de hospitalizacion se realizo un control clinico al final del primer mes y un control clinico y angiografico a los 6 meses. Resultados Fueron excluidos 27 pacientes despues del procedimiento (por no lograrse el implante en 5, por resultado inadecuado en 15 o por indicarse regimen de anticoagulacion en 7). En los 341 pacientes con resultado adecuado, el 88% de los stents fueron implantados sobre lesiones de novo y el 12% sobre lesiones de reestenosis. El mayor porcentaje de lesiones eran tipo B del American College of Cardiology- American Heart Association, con un 39,1% de lesiones tipo B2 y un 8,5% tipo C. Se produjo oclusion subaguda de 2 stents (0,6%); 7 pacientes (2,1%) presentaron complicaciones vasculares secundarias a la puncion arterial y no existieron complicaciones hemorragicas mayores con necesidad de transfusion. La reestenosis angiografica a los 6 meses fue del 19,8%. Conclusiones Cuando el resultado angiografico de la implantacion electiva del stent Wiktor es optimo, la terapia con aspirina y ticlopidina exclusivamente se acompana de un indice muy bajo de oclusion trombotica, de complicaciones hemorragicas y vasculares y de reestenosis clinica y angiografica a los 6 meses.