RESUMEN Introducción y objetivos: El tratamiento de los pacientes con fibrilación auricular no valvular (FANV) que requieren implante de stents coronarios es un desafío. El objetivo del estudio fue investigar si el cierre de la orejuela izquierda (COI) podría ser una opción posible y beneficiosa para estos pacientes. Para ello, se analiza el impacto del COI más tratamiento antiagregante plaquetario (AP) en comparación con la combinación de anticoagulantes orales (ACO), incluidos los ACO directos, y tratamiento AP en los resultados a largo plazo de estos pacientes Métodos: Se analizaron los resultados de 207 pacientes con FANV sometidos consecutivamente a implante de stents coronarios. Recibieron ACO 146 pacientes (74 acenocumarol, 71 ACO de acción directa) y en 61 se realizó COI. La mediana de seguimiento fue de 35 meses. Los pacientes también recibieron tratamiento AP por prescripción de su cardiólogo. El estudio recibió la debida supervisión ética. Resultados: La edad (media: 75,7 años) y el antecedente de accidente vascular cerebral fueron similares en ambos grupos, aunque el grupo de COI presentó más características desfavorables (antecedente de enfermedad de las arterias coronarias [CHA2DS2-VASc], antecedente de hemorragias significativas [BARC ≥ 2] y HAS-BLED). La aparición de acontecimientos adversos graves (muerte, accidente vascular cerebral, accidente isquémico transitorio, hemorragia grave) y cardiovasculares graves (muerte de causa cardiaca, accidente vascular cerebral, accidente isquémico transitorio, infarto de miocardio) fue significativamente mayor en el grupo de ACO que en el de COI: 19,75 frente a 9,06% (HR = 2,18; p = 0,008) y 6,37 frente a 1,91% (HR = 3,34; p = 0,037), respectivamente. Conclusiones: La combinación de COI y tratamiento AP en pacientes con FANV conlleva mejor pronóstico clínico a largo plazo que el tratamiento con ACO y terapia AP, a pesar de las características basales desfavorables del grupo de COI.

ABSTRACT Introduction and objectives: The treatment of patients with non-valvular atrial fibrillation (NVAF) who need coronary stenting is challenging. The objective of the study was to determine whether left atrial appendage occlusion (LAAO) could be a feasible option and benefit these patients. To this end, we studied the impact of LAAO plus antiplatelet drugs vs oral anticoagulants (OAC) (including direct OAC) plus antiplatelet drugs in these patients' long-term outcomes. Methods: The results of 207 consecutive patients with NVAF who underwent coronary stenting were analyzed. A total of 146 patients were treated with OAC (75 with acenocoumarol, 71 with direct OAC) while 61 underwent LAAO. The median follow-up was 35 months. Patients also received antiplatelet therapy as prescribed by their cardiologist. The study received the proper ethical oversight. Results: Age (mean 75.7 years), and the past medical history of stroke were similar in both groups. However, the LAAO group had more unfavorable characteristics (history of coronary artery disease [CHA2DS2-VASc], and significant bleeding [BARC ≥ 2] and HAS-BLED). The occurrence of major adverse events (death, stroke/transient ischemic events, major bleeding) and major cardiovascular events (cardiac death, stroke/transient ischemic attack, and myocardial infarction) were significantly higher in the OAC group compared to the LAAO group: 19.75% vs 9.06% (HR, 2.18; P = .008) and 6.37% vs 1.91% (HR, 3.34; P = .037), respectively. Conclusions: In patients with NVAF undergoing coronary stenting, LAAO plus antiplatelet therapy produced better long-term outcomes compared to treatment with OAC plus antiplatelet therapy despite the unfavorable baseline characteristics of the LAAO group.

RESUMEN Introducción y objetivos: La calcificación coronaria es uno de los principales factores que inciden negativamente en la seguridad y la eficacia del intervencionismo coronario percutáneo. Existen varias técnicas de modificación del calcio, pero falta evidencia de estudios aleatorizados sobre la terapia de elección en este escenario. Métodos: El ROLLERCOASTR es un estudio prospectivo, multicéntrico y aleatorizado, diseñado para comparar la seguridad y la eficacia de 3 técnicas de modificación de la placa en el contexto de calcificación coronaria moderada o grave: aterectomía rotacional (AR), aterectomía coronaria con láser láser excimer (ACLE) y litotricia intracoronaria (LIC). El objetivo primario es la expansión del stent evaluada mediante tomografía de coherencia óptica. Su análisis se hará por intención de tratar, con un α de 0,05 entre el grupo de referencia (AR) y cada uno de los otros grupos (ACLE y LIC). Se realizará también un análisis del objetivo primario por protocolo para mantener la coherencia. Si se confirma la hipótesis de no inferioridad, se realizará un análisis bilateral de superioridad. El comité de eventos clínicos y el laboratorio central independiente no conocerán la rama de tratamiento. Asumiendo un error α de 0,05, un error β de 0,2 (80% de potencia), un margen de irrelevancia (ε) del 7% y un 10% de pérdidas por dificultad de medición o imposibilidad de completar la intervención, se estima un tamaño de muestra de 56 casos en cada grupo. Los objetivos secundarios son el éxito del dispositivo, el éxito del procedimiento, la tasa de cruce entre técnicas y la presentación de eventos cardiovasculares adversos importantes al año de seguimiento. Conclusiones: El estudio ROLLERCOASTR evaluará y comparará la seguridad y la eficacia, en pacientes con estenosis coronaria calcificada, de 3 técnicas de modificación de placa: AR, ACLE y LIC. Este ensayo se ha registrado en Clinicaltrials.gov: NCT04181268.

ABSTRACT Introduction and objectives: Coronary calcification is one of the leading factors that affect negatively the safety and effectiveness of percutaneous coronary intervention. Several calcium modification techniques exist. However, there is a lack of randomized evidence on the therapy of choice in this scenario. Methods: The ROLLERCOASTR is a prospective, multicenter, randomized clinical trial designed to compare the safety and efficacy profile of 3 plaque modification techniques in the moderate-to-severe coronary calcification setting: rotational atherectomy (RA), excimer laser coronary angioplasty (ELCA), and intravascular lithotripsy (IVL). The study primary endpoint is stent expansion evaluated by optical coherence tomography. An intention-to-treat analysis will be conducted with an alpha coefficient of 0.05 between the reference group (RA) and the remaining 2 groups (ELCA and IVL). An analysis of the study primary endpoint per protocol will be conducted for consistency purposes. If the non-inferiority hypothesis is confirmed, a superiority 2-sided analysis will be conducted. Both the clinical events committee and the independent core laboratory will be blinded to the treatment arm. Assuming an α error of 0.05, an β error of 0.2 (80% power), a margin of irrelevance (ε) of 7, and losses of 10% due to measurement difficulty or impossibility to complete the intervention, we estimate a sample size of 56 cases per group. The study secondary endpoints are device success, procedural success, crossover rate among the different techniques used, and the occurrence of major adverse cardiovascular events at 1-year follow-up. Conclusions: The ROLLERCOASTR trial will evaluate and compare the safety and effectiveness of 3 plaque modification techniques: RA, ELCA, and IVL in patients with calcified coronary stenosis. This trial was registered at clinicaltrials.gov with identifier NCT04181268.

RESUMEN Introducción y objetivos: La Asociación de Cardiología Intervencionista de la Sociedad Española de Cardiología (ACI-SEC) y el Grupo de Trabajo de Hemodinámica de la Sociedad Española de Cardiología Pediátrica y Cardiopatías Congénitas (GTH-SECPCC) presentan su informe anual de actividad hemodinámica en cardiopatías congénitas correspondiente al año 2021. Métodos: Se invitó a participar a los centros españoles con laboratorio de hemodinámica y actividad intervencionista en cardiopatías congénitas. La recogida de datos fue telemática y su análisis lo efectuó una empresa externa junto con miembros de la ACI-SEC y el GTH-SECPCC. Resultados: Participaron 16 centros (15 públicos y 1 privado) que acumulan 34 salas de hemodinámica con actividad en cardiopatías congénitas, 7 (20,5%) de ellas con dedicación exclusiva a pacientes pediátricos. Se registraron 1.094 estudios diagnósticos (5,1% más que en 2020) y 1.553 cateterismos intervencionistas (6,4% más que en 2020). Las técnicas más frecuentes fueron el cierre de comunicación interauricular (336 casos), la angioplastia de ramas pulmonares (231 casos) y el cierre de ductus (228 casos). Respecto al año anterior se incrementaron significativamente las técnicas de implantación de válvulas percutáneas (29,3%), cierre de ductus (20,6%) y angioplastia aórtica (12,8%). La tasa de éxito en los procedimientos intervencionistas fue del 95%, con una tasa de complicaciones mayores del 2,7% y una mortalidad intrahospitalaria del 0,2%. Conclusiones: Este trabajo es la segunda publicación del Registro Español de Intervencionismo en Cardiopatías Congénitas. Se ha constatado un aumento significativo de los procedimientos diagnósticos y terapéuticos, destacando el incremento en la implantación de válvulas percutáneas, el cierre de ductus y la angioplastia aórtica. La mayoría de las técnicas intervencionistas siguen demostrando excelentes datos de seguridad y eficacia.

ABSTRACT Introduction and objectives: This is the 2021 annual activity report from the Interventional Cardiology Association of the Spanish Society of Cardiology (ACI-SEC), and the Interventional Working Group of the Spanish Society of Pediatric Cardiology (GTH-SECPCC). Methods: All Spanish centers with cath lab capabilities and interventional activity in congenital heart diseases were invited to participate. Data were collected online, analyzed by an external company, and ACI-SEC and GTH-SECPCC members. Results: A total of 16 centers participated 15 public and 1 private including 34 cath labs with experience in congenital heart diseases, 7 of them (20.5%) exclusively dedicated to pediatric patients. A total of 1094 diagnostic studies (4.5% more than 2020) and 1553 interventional catheterizations (5.8% more than 2020) were registered. The most common procedures were atrial septal defect closure (336 cases), pulmonary branch artery angioplasty (231 cases), and percutaneous closure of the patent ductus arteriosus (228 cases). Interventional procedures were considered successful in 95% of the cases with rates of major procedural complication and in-hospital mortality of 2.7% and 0.2%, respectively. Conclusions: This is the second Spanish Cardiac Catheterization in Congenital Heart Diseases Registry report. A significant increase of diagnostic and interventional procedures was reported with a special increase of percutaneous valve implantation, ductus arteriosus closure, and aortic angioplasty. Most interventional techniques continue to demonstrate excellent safety and efficacy outcomes.

INTRODUÇÃO: Há poucos dados na literatura que avaliam a obstrução coronária após implante transcateter de válvula aórtica (TAVI, do inglês transcatheter aortic valve implantation) para o tratamento de disfunção de bioprótese aórtica (valve-in-valve - ViV). O presente estudo avaliou, por meio de revisão sistemática da literatura, as características clínicas, o manejo e os desfechos clínicos de pacientes com obstrução coronária após TAVI-ViV. MÉTODOS: Estudos publicados entre 2002 e 2013 avaliando a obstrução coronária como complicação de TAVI-ViV foram identificados por meio de busca eletrônica sistemática. Foram avaliados dados basais sobre as características clínicas e do procedimento, manejo da complicação e desfechos clínicos. RESULTADOS: Foram identificadas, no total, quatro publicações descrevendo sete pacientes. A maioria dos pacientes era do sexo feminino (71%), sendo a média de idade de 82 ± 5 anos, com STS-PROM de 9,4 ± 2,6%. As médias da altura do tronco da artéria coronária esquerda (TCE) e o diâmetro médio da raiz aórtica foram de 8,8 ± 1,5 mm e 28,0 ± 5,0 mm, respectivamente. A maioria dos pacientes apresentava biopróteses com suporte e folhetos montados externamente, ou eram próteses sem suporte (stentless) e o TCE foi envolvido em todos os casos. A intervenção coronária percutânea (ICP) foi tentada em todos os pacientes, tendo sucesso em quatro deles (57%). A mortalidade intra-hospitalar foi 42,9% (três casos), todos após ICP sem sucesso. CONCLUSÕES: A obstrução coronária após TAVI-ViV ocorreu mais frequentemente em mulheres com bioprótese com suporte e folheto montado externamente ou com bioprótese sem suporte. O TCE foi envolvido em todos os casos e a ICP foi realizada com sucesso em 60% deles. Esforços contínuos poderão auxiliar na detecção dos fatores associados a essa complicação, no intuito de se implementarem medidas apropriadas para sua prevenção.

BACKGROUND: Very few data exist on coronary obstruction following transcatheter aortic valve implantation (TAVI) for degenerative bioprosthetic valves (valve-in-valve - ViV). The present study evaluated, through a systematic review of the literature, the clinical characteristics, management and clinical outcomes of patients with coronary obstruction after ViV-TAVI. METHODS: Studies published between 2002 and 2013 evaluating coronary obstruction as a complication of ViV-TAVI were identified using a systematic electronic search. Data on the clinical and procedural characteristics, management of the complication, and clinical outcomes were analyzed. RESULTS: A total of four publications describing seven patients were identified. Most patients (71%) were women, with mean age of 82 ± 5 years, and STS-PROM score of 9.4 ± 2.6%. Mean left coronary artery (LCA) ostium height and aortic root width were 8.8 ± 1.5 mm and 28.0 ± 5.0 mm, respectively. Most patients had stented bioprosthetic valves with externally mounted leaflets or stentless aortic bioprosthesis, and the LCA was involved in all patients. Percutaneous coronary intervention (PCI) was attempted in all patients and was successful in four (57%). In-hospital mortality was 42.9% (three cases), all of them after failed PCI. CONCLUSIONS: Coronary obstruction following ViV-TAVI occurred more frequently in women with stented bioprosthetic valves with externally mounted leaflets or with stentless bioprosthesis. The LCA was involved in all cases and PCI was successful in 60% of them. Continued efforts may help identify the factors associated with this complication so that appropriate prevention measures may be implemented.