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Coronary obstruction (CO) is a rare but potentially fatal complication of transcatheter aortic valve implantation (TAVI). The present article aims to summarize the evidence on CO risk factors and provide an overview of preventive strategies. We performed a comprehensive literature review focused on these items. The analysis included studies addressing patient-specific characteristics, procedural aspects, and the effectiveness of various prevention techniques in mitigating CO risk. Specific risk factors for CO, which can be assessed by evaluating patient characteristics using computed tomography, are described. Procedural factors associated with an increased risk of CO are discussed. Preventive techniques, including the chimney stent and bioprosthetic aortic scallop intentional laceration to prevent iatrogenic coronary artery obstruction (BASILICA), are also described, highlighting the advantages and disadvantages of each method. The present review also provides an overview of emerging dedicated devices designed to address this complication. In conclusion, identifying patients at risk for CO is crucial for optimizing TAVI outcomes. Comprehensive imaging assessment and appropriate preventive strategies, such as the BASILICA technique, can mitigate the risk of CO and improve patient outcomes. Further research is needed to validate emerging dedicated devices.

La obstrucción de las arterias coronarias (OC) es una complicación rara, pero potencialmente fatal, del implante percutáneo de válvula aórtica (TAVI). El objetivo de esta revisión es resumir la evidencia sobre los factores de riesgo de OC y las estrategias preventivas. Se realizó una revisión integral de la literatura centrada en estos aspectos. El análisis consideró estudios que abordaran las características del paciente, los factores procedimentales y la efectividad de diferentes técnicas preventivas para reducir el riesgo de OC. Se describen los factores relacionados con el paciente y del procedimiento que condicionan un mayor riesgo de OC. A lo largo del texto se detallan las técnicas para disminuir el riesgo de OC, incluidos el stent en chimenea y la técnica BASILICA. Además, se aporta una descripción general de los dispositivos diseñados para abordar esta complicación. En conclusión, la identificación de los factores de riesgo de OC es crucial para optimizar los resultados del TAVI. La evaluación exhaustiva mediante imagen multimodal, junto a estrategias preventivas apropiadas, como la técnica BASILICA, pueden mitigar el riesgo de OC y mejorar los resultados. Aún se requiere más investigación para validar los dispositivos emergentes.

RESUMEN Introducción y objetivos: El abordaje sistemático en pacientes con angina con arterias coronarias no obstruidas (ANOCA) o con isquemia con arterias coronarias no obstruidas (INOCA) no está bien protocolizado. Métodos: Todos los pacientes con diagnóstico de INOCA o ANOCA se trasladaron a una clínica ambulatoria específica para evaluar su elegibilidad para el programa NOCA. Si eran elegibles, se sometían a una angiografía coronaria programada con pruebas de función coronaria y provocación intracoronaria con acetilcolina. La terapia médica se optimizó en consecuencia. Todos los pacientes tuvieron un seguimiento a 1, 3, 6 y 12 meses. Al inicio y a los 3 meses se aplicaron los cuestionarios SAQ y EuroQol-5D. Resultados: De 77 pacientes se excluyeron 23 (29,9%) y se incluyeron 54 (70,1%) (29 [53,7%] con INOCA y 25 [46,3%] con ANOCA). Se diagnosticó angina microvascular a 19 (35,2 %) pacientes, angina vasoespástica a 12 (22,2 %), angina microvascular y angina vasoespástica a 18 (33,3 %), y dolor torácico no coronario a 5 (9,3 %). Hubo un aumento significativo en el uso de bloqueadores beta, bloqueadores del calcio y nitratos. Se presentaron complicaciones en 3 (5,5%) pacientes. No hubo diferencias en la puntuación media del EQ-5D a los 3 meses y se observó una...

ABSTRACT Introduction and objectives: A systematic approach to patients with angina with no obstructed coronary arteries (ANOCA) or ischemia with no obstructed coronary arteries (INOCA) patients is not routinely implemented. Methods: All consecutive patients diagnosed with ANOCA/INOCA were referred to a designated outpatient clinic for a screening visit to assess their eligibility for a NOCA program. If eligible, patients underwent scheduled coronary angiograms with coronary function testing and intracoronary acetylcholine provocation testing. Medical therapy was optimized accordingly. All patients were then followed up at 1, 3, 6, and 12 months. Baseline and 3-month follow-up assessments included the Seattle Angina Questionnaire (SAQ) and EuroQol-5D questionnaire. Results: Of 77 patients screened, 23 (29.9%) were excluded and 54 (70.1%) were included (29 [53.7%] with INOCA and 25 [46.3%] with ANOCA). Microvascular angina was diagnosed in 19 (35.2%) patients, vasospastic angina in 12 (22.2%), both microvascular angina and vasospastic angina in 18 (33.3%), and noncoronary chest pain in 5 (9.3%). There was a notable increase in the use of beta-blockers, calcium channel blockers and nitrates. Complications occurred in 3 (5.5%) patients. Compared with baseline, there was no difference in the mean EQ-5D score at the 3-month follow-up, but there was a significant improvement in the SAQ score...

Background: Lesions with thin-cap fibroatheroma (TCFA), small luminal area and large plaque burden (PB) have been considered at high risk of cardiovascular events. Older patients were not represented in studies which demonstrated correlation between clinical outcome and plaque characteristics. This study aims to investigate the prognostic role of high-risk plaque characteristics and long-term outcome in older patients presenting with non-ST elevation acute coronary syndrome (NSTEACS). Methods: This study recruited older patients aged ≥75 years with NSTEACS undergoing virtual-histology intravascular ultrasound (VH-IVUS) imaging from the Improve Clinical Outcomes in high-risk patieNts with acute coronary syndrome (ICON-1). Primary endpoint was the composite of major adverse cardiovascular events (MACE) consisting of all-cause mortality, myocardial infarction (MI), and any revascularisation. Every component of MACE and target vessel failure (TVF) including MI and any revascularisation were considered as secondary endpoints. Results: Eighty-six patients with 225 vessels undergoing VH-IVUS at baseline completed 5-year clinical follow-up. Patients with minimal lumen area (MLA) ≤4 mm2 demonstrated increased risk of MACE (hazard ratio [HR] 2.37, 95% confidence interval [CI] 1.00–5.59, p = 0.048) with a worse event-free survival (Log Rank 4.17, p = 0.041) than patients with MLA >4 mm2. Patients with combination of TCFA, MLA ≤4 mm2 and PB ≥70% showed high risk of MI (HR 5.23, 95% CI 1.05–25.9, p = 0.043). Lesions with MLA ≤4 mm2 had 6-fold risk of TVF (HR 6.16, 95% CI 1.24–30.5, p = 0.026). Conclusions: Small luminal area appears as the major prognostic factor in older patients with NSTEACS at long-term follow-up. Combination of TCFA, MLA ≤4 mm2 and PB ≥70% was associated with high risk of MI. Clinical Trial Registration: NCT01933581.

Sr. Editor: El infarto de miocardio es la principal causa de morbimortalidad en nuestro medio. La intervención coronaria percutánea primaria ha mejorado el pronóstico de los pacientes con infarto agudo de miocardio con elevación del segmento ST (IAMCEST)1. Sin embargo, existe un subgrupo de pacientes que sufren una reperfusión miocárdica subóptima con aparición de fibrosis miocárdica, disfunción ventricular y desarrollo de insuficiencia cardiaca2. Últimamente se han desarrollado varias estrategias farmacológicas e intervencionistas para mejorar estos resultados3. El sistema PiCSO (Pressure-controlled intermittent Coronary Sinus Occlusion), desarrollado por Miracor Medical SA (Bélgica), consiste en un catéter-balón que permite ocluir periódicamente el seno coronario: 1) En la fase de oclusión (5-15 s), el flujo venoso se redistribuye desde áreas bien perfundidas hacia regiones isquémicas me-diante la formación de circulación colateral. Además, por un aumento de la presión sistólica venosa, el fenómeno de plasma skimming permite perfundir mejor las vénulas con plasma rico en oxígeno y metabolitos. 2) En la fase de liberación (3-4 s), la rápida caída de la presión venosa crea un gradiente que lleva al lavado de restos trombóticos, metabolitos tóxicos y edema miocárdico. 3) Se cree que estas variaciones de presión pueden inducir una mecanotransducción activando células vasculares y liberando factores de crecimiento, sustancias vasodilatadoras...

To the Editor, Myocardial infarction is the leading cause of morbidity and mortality in our setting. Percutaneous coronary intervention has improved the prognosis of patients with ST-segment elevation myocardial infarction (STEMI).1 However, there is a subgroup of patients who suffer from suboptimal myocardial reperfusion with appearance of myocardial fibrosis, ventricular dysfunction, and development of heart failure.2 Recently, several pharmaceutical and procedural strategies have been developed to improve these results.3 The PiCSO system (Pressure-controlled intermittent coronary sinus occlusion) developed by Miracor Medical SA, Belgium consists of a balloon catheter to occlude the coronary sinus periodically: 1) During the occlusion stage (5 to 15 s), venous flow is redistributed from well perfused areas towards ischemic regions through the formation of collateral circulation. Also, through an increased venous systolic pressure, the plasma skimming phenomenon allows better perfusion of venules with oxygen-and-metabolite-rich plasma. 2) During the release stage (3 to 4 s) the dramatic drop of venous pressure creates a gradient that ends up clearing all thrombotic debris, toxic metabolites, and myocardial edema. 3) These pressure variations can induce mechanotransduction by activating vascular cells and releasing growth factors, vasodilator substances, and microRNA into microcirculation (figure 1). Figure 1. Representation of the mechanism of action of the PiCSO system in the...

Abstract Aims Inhibitors of SGLT2 (SGLT2i) have shown a positive impact in patients with chronic heart failure and reduced ejection fraction (HFrEF). Nonetheless, the direct effects of SGLT2i on cardiac cells and how their association with main drugs used for HFrEF affect the behaviour and signalling pathways of myocardial fibroblasts are still unknown. We aimed to determine the effects of dapagliflozin alone and in combination with sacubitril/valsartan (LCZ696) or spironolactone on the function of myocardial fibroblasts of patients with heart failure and reduced ejection fraction (HFrEF). Methods and results Myocardial fibroblasts isolated from HFrEF patients (n = 5) were treated with dapagliflozin alone (1 nM–1 μM) or combined with LCZ696 (100 nM) or spironolactone (100 nM). The migratory rate was determined by wound‐healing scratch assay. Expression of heart failure (HF) markers and signalling pathways activation were analysed with multiplexed protein array. Commercially available cardiac fibroblasts from healthy donors were used as Control (n = 4). Fibroblasts from HFrEF show higher migratory rate compared with control (P = 0.0036), and increased expression of HF markers [fold‐change (Log2): COL1A1–1.3; IL‐1b–1.9; IL‐6–1.7; FN1–2.9 (P

Background ST‐segment–elevation myocardial infarction complicated with no reflow after primary percutaneous coronary intervention is associated with adverse outcomes. Although several hyperemic drugs have been shown to improve the Thrombolysis in Myocardial Infarction flow, optimal treatment of no reflow remains unsettled. Saline infusion at 20 mL/min via a dedicated microcatheter causes (flow‐mediated) hyperemia. The objective is to compare the efficacy of pharmacologic versus flow‐mediated hyperemia in patients with ST‐segment–elevation myocardial infarction complicated with no reflow. Methods and Results In the RAIN‐FLOW (Treatment of Slow‐Flow After Primary Percutaneous Coronary Intervention With Flow‐Mediated Hyperemia) study, 67 patients with ST‐segment–elevation myocardial infarction and no reflow were randomized to receive either pharmacologic‐mediated hyperemia with intracoronary adenosine or nitroprusside (n=30) versus flow‐mediated hyperemia (n=37). The angiographic corrected Thrombolysis in Myocardial Infarction frame count and the minimal microcirculatory resistance, as assessed with intracoronary pressure‐thermistor wire, dedicated microcatheter, and thermodilution techniques, were compared after study interventions. Both Thrombolysis in Myocardial Infarction frame count(40.2±23.1 versus 39.2±20.7; P=0.858) and minimal microcirculatory resistance (753.6±661.5 versus 993.3±740.8 Wood units; P=0.174) were similar between groups. Thrombolysis in Myocardial Infarction 3 flow was observed in 26.7% versus 27.0% (P=0.899). Flow‐mediated hyperemia showed 2 different thermodilution patterns during saline infusion indicative of the severity of the no reflow phenomenon. In‐hospital death and nonfatal heart failure were observed in 10.4% and 26.9%, respectively. Conclusions Both treatments showed similar (and limited) efficacy restoring coronary flow. Flow‐mediated hyperemia with thermodilution pattern assessment allowed the simultaneous characterization of the no reflow degree and response to hyperemia. No reflow was associated with a high rate of adverse outcomes. Further research is warranted to prevent and to treat no reflow in patients with ST‐segment–elevation myocardial infarction. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT04685941.

RESUMEN Introducción y objetivos: Los pacientes con estenosis en el tronco coronario izquierdo (TCI) han sido excluidos de los ensayos que apoyan la no inferioridad del cociente de presiones en el índice diastólico instantáneo sin ondas (iFR) respecto a la reserva fraccional de flujo (RFF) en la toma de decisiones sobre revascularización coronaria. El presente estudio propone valorar de manera prospectiva la concordancia entre los dos índices en lesiones del TCI y validar el valor de corte del iFR de 0,89 para su uso clínico. Métodos: Registro multicéntrico nacional, prospectivo, observacional, con la inclusión de 300 pacientes consecutivos con lesiones intermedias (estenosis angiográfica 25-60%) en el TCI. Se realizará un estudio con guía de presión y determinación de RFF e iFR. En caso de resultado concordante negativo (RFF > 0,80 / iFR > 0,89), no se realizará tratamiento; en caso de resultado concordante positivo (RFF ≤ 0,80 / iFR ≤ 0,89), se realizará revascularización; en caso de resultado discordante (RFF > 0,80 / iFR ≤ 0,89 o RFF ≤ 0,80 / iFR > 0,89), se realizará estudio con ecocardiografía intravascular y se considerará diferir la revascularización si el área luminal mínima es > 6 mm2. El criterio de valoración clínico primario será la incidencia del combinado de muerte cardiovascular, infarto no mortal relacionado con la lesión del TCI o necesidad de revascularización de la lesión del TCI a los 12 meses. Conclusiones: La demostración de la seguridad clínica en la toma de decisiones del iFR en pacientes con lesiones intermedias en el TCI tendría un impacto clínico importante y justificaría su uso sistemático para la decisión del tratamiento en estos pacientes de potencial alto riesgo. Registrado en ClinicalTrials.gov (identificador: NCT03767621).

ABSTRACT Introduction and objectives: Patients with left main coronary artery (LMCA) stenosis have been excluded from the trials that support the non-inferiority of the instantaneous wave-free ratio (iFR) compared to the fractional flow reserve (FFR) in the decision-making process of coronary revascularization. This study proposes to prospectively assess the concordance between the two indices in LMCA lesions and to validate the iFR cut-off value of 0.89 for clinical use. Methods: National, prospective, and observational multicenter registry of 300 consecutive patients with intermediate lesions in the LMCA (angiographic stenosis, 25% to 60%. A pressure gudiewire study and determination of the RFF and the iFR will be performed: in the event of a negative concordant result (FFR > 0.80/iFR > 0.89), no treatment will be performed; in case of a positive concordant result (FFR ≤ 0.80/iFR ≤ 0.89), revascularization will be performed; In the event of a discordant result (FFR> 0.80/iFR ≤ 0.89 or FFR ≤ 0.80/iFR> 0.89), an intravascular echocardiography will be performed and revascularization will be delayed if the minimum lumen area is > 6 mm2. The primary clinical endpoint will be a composite of cardiovascular death, LMCA lesion-related non-fatal infarction or need for revascularization of the LMCA lesion at 12 months. Conclusions: Confirm that an iFR-guided decision-making process in patients with intermediate LMCA stenosis is clinically safe and would have a significant clinical impact. Also, justify its systematic use when prescribing treatment in these potentially high-risk patients. Registered at ClinicalTrials.gov ( Identifier: NCT03767621).

Atrial fibrillation (AF) is the most common arrhythmia worldwide. It is associated with increased mortality and morbidity, especially due to the increased risk of ischemic stroke and systemic embolism in these patients. For this reason, thromboembolism prevention is the cornerstone of managing AF, and oral anticoagulation is nowadays the first-line treatment. However, since most thrombi form in the left atrial appendage and anticoagulant therapy may have side effects and be contraindicated in some patients, surgical and percutaneous left atrial appendage occlusion (LAAO) have emerged as a non-pharmacological alternative. This review summarizes all existing evidence on surgical and percutaneous LAAO.

Background Long‐term outcomes of ST‐segment–elevation myocardial infarction in patients with diabetes have been barely investigated. The objective of this analysis from the EXAMINATION‐EXTEND (10‐Years Follow‐Up of the EXAMINATION trial) trial was to compare 10‐year outcomes of patients with ST‐segment–elevation myocardial infarction with and without diabetes. Methods and Results Of the study population, 258 patients had diabetes and 1240 did not. The primary end point was patient‐oriented composite end point of all‐cause death, any myocardial infarction, or any revascularization. Secondary end points were the individual components of the primary combined end point, cardiac death, target vessel myocardial infarction, target lesion revascularization, and stent thrombosis. All end points were adjusted for potential confounders. At 10 years, patients with diabetes showed a higher incidence of patient‐oriented composite end point compared with those without (46.5% versus 33.0%; adjusted hazard ratio [HR], 1.31 [95% CI, 1.05–1.61]; P=0.016) mainly driven by a higher incidence of any revascularization (24.4% versus 16.6%; adjusted HR, 1.61 [95% CI, 1.19–2.17]; P=0.002). Specifically, patients with diabetes had a higher incidence of any revascularization during the first 5 years of follow‐up (20.2% versus 12.8%; adjusted HR, 1.57 [95% CI, 1.13–2.19]; P=0.007) compared with those without diabetes. No statistically significant differences were found with respect to the other end points. Conclusions Patients with ST‐segment–elevation myocardial infarction who had diabetes had worse clinical outcome at 10 years compared with those without diabetes, mainly driven by a higher incidence of any revascularizations in the first 5 years. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT04462315.

ABSTRACT Ischemic heart disease is the most common cause of death worldwide. In patients with ST-segment elevation myocardial infarction (STEMI), optimizing primary percutaneous coronary intervention is crucial to improve prognosis. Over the years, many studies have been published on the value of second-generation stents, strategies to reduce myocardial damage, how to achieve complete revascularization and also on percutaneous mechanical circulatory support devices, which all are attractive therapeutic options to treat patients with STEMI complicated by cardiogenic shock. In this review we will be discussing how primary percutaneous coronary intervention can be optimized with respect to stent selection and revascularization strategy to reduce myocardial damage and improve clinical outcomes. In addition, we review published data on the use of mechanical circulatory support devices in patients with STEMI complicated by cardiogenic shock.

RESUMEN La cardiopatía isquémica es la causa más común de mortalidad en todo el mundo. En pacientes con infarto agudo de miocardio con elevación del segmento ST (IAMCEST), la optimización de la intervención coronaria percutánea primaria es crucial para mejorar el pronóstico. Durante estos últimos años se han publicado muchos estudios sobre el valor de los stents de segunda generación, sobre estrategias para reducir el daño miocárdico, sobre cómo conseguir la revascularización completa y sobre dispositivos de apoyo circulatorio mecánico percutáneo que representan una opción terapéutica atractiva en pacientes con IAMCEST complicado con shock cardiogénico. En esta revisión se discute cómo se puede optimizar la intervención coronaria percutánea primaria con respecto a la selección de los stents y la estrategia de revascularización, con el fin de reducir el daño miocárdico y mejorar los resultados clínicos. Además, se revisan los datos publicados sobre el uso de dispositivos de apoyo circulatorio mecánico en pacientes con IAMCEST complicado por shock cardiogénico.

Injury of the circumflex artery is an uncommon but dangerous complication during mitral valve surgery. We report the case of a patient who presented an occlusion of the circumflex artery after a minimally invasive mitral valve repair, which was treated with angioplasty in the immediate post-operative period. (Level of Difficulty: Intermediate.)

Up to 60–70% of patients, undergoing invasive coronary angiography due to angina and demonstrable myocardial ischemia with provocative tests, do not have any obstructive coronary disease. Coronary microvascular angina due to a dysfunction of the coronary microcirculation is the underlying cause in almost 50% of these patients, associated with a bad prognosis and poor quality of life. In recent years, progress has been made in the diagnosis and management of this condition. The aim of this review is to provide an insight into current knowledge of this condition, from current diagnostic methods to the latest treatments.

Myocardial infarction with non-obstructive coronary arteries (MINOCA) is a heterogeneous group of clinical entities characterized by the common clinical evidence of myocardial infarction (MI) with non-obstructive coronary arteries on coronary angiography and without an overt cause for the MI. Platelets play a cornerstone role in the pathophysiology of MI with obstructive coronary arteries. Accordingly, antiplatelet therapy is recommended for treating patients with MI and obstructive coronary disease. However, the role of platelets in the pathophysiology of MINOCA patients is not fully defined, questioning the role of antiplatelet therapy in this setting. In this review, we will assess the role of antiplatelet therapy in MINOCA with a focus on the pathophysiology, therapeutic targets, current evidence, and future directions according to its different etiologies.

BackgroundThe long-term cardiovascular (CV) outcomes of COVID-19 have not been fully explored.MethodsThis was an international, multicenter, retrospective cohort study conducted between February and December 2020. Consecutive patients ≥18 years who underwent a real-time reverse transcriptase-polymerase chain reaction (RT-PCR) for SARS-CoV2 were included. Patients were classified into two cohorts depending on the nasopharyngeal swab result and clinical status: confirmed COVID-19 (positive RT-PCR) and control (without suggestive symptoms and negative RT-PCR). Data were obtained from electronic records, and clinical follow-up was performed at 1-year. The primary outcome was CV death at 1-year. Secondary outcomes included arterial thrombotic events (ATE), venous thromboembolism (VTE), and serious cardiac arrhythmias. An independent clinical event committee adjudicated events. A Cox proportional hazards model adjusted for all baseline characteristics was used for comparing outcomes between groups. A prespecified landmark analysis was performed to assess events during the post-acute phase (31-365 days).ResultsA total of 4,427 patients were included: 3,578 (80.8%) in the COVID-19 and 849 (19.2%) control cohorts. At one year, there were no significant differences in the primary endpoint of CV death between the COVID-19 and control cohorts (1.4% vs. 0.8%; HRadj 1.28 [0.56-2.91]; p = 0.555), but there was a higher risk of all-cause death (17.8% vs. 4.0%; HRadj 2.82 [1.99-4.0]; p = 0.001). COVID-19 cohort had higher rates of ATE (2.5% vs. 0.8%, HRadj 2.26 [1.02-4.99]; p = 0.044), VTE (3.7% vs. 0.4%, HRadj 9.33 [2.93-29.70]; p = 0.001), and serious cardiac arrhythmias (2.5% vs. 0.6%, HRadj 3.37 [1.35-8.46]; p = 0.010). During the post-acute phase, there were no significant differences in CV death (0.6% vs. 0.7%; HRadj 0.67 [0.25-1.80]; p = 0.425), but there was a higher risk of deep vein thrombosis (0.6% vs. 0.0%; p = 0.028). Re-hospitalization rate was lower in the COVID-19 cohort compared to the control cohort (13.9% vs. 20.6%; p = 0.001).ConclusionsAt 1-year, patients with COVID-19 experienced an increased risk of all-cause death and adverse CV events, including ATE, VTE, and serious cardiac arrhythmias, but not CV death.Study registrationURL: https://www.clinicaltrials.gov. Unique identifier: NCT04359927.

RESUMEN Durante marzo de 2020, el virus SARS-CoV-2 se ha extendido por toda Europa, con especial intensidad en Italia y España. Ante la emergencia creada por el brote de COVID-19, la inmensa mayoría de las salas de hemodinámica y electrofisiología han visto alterada su actividad habitual. Además se enfrentan a la realización de procedimientos en pacientes con diagnóstico confirmado de COVID-19 o con la incertidumbre en casos no confirmados. El presente texto es un documento de consenso de la Asociación de Cardiología Intervencionista y la Asociación del Ritmo Cardiaco de la Sociedad Española de Cardiología que pretende dar información al personal sanitario de estas instalaciones de cardiología invasiva (hemodinámica y electrofisiología y marcapasos) para garantizar una atención de calidad a los pacientes así como unos niveles los niveles adecuados de prevención de la infección.

ABSTRACT During March 2020, the SARS-CoV-2 virus spread throughout Europe, with the spread being especially intense in Italy and Spain. Given the emergency created by the COVID-19 outbreak, routine activity has been altered in most cardiac catheterization and electrophysiology labs. Health staff working in these areas are faced with performing procedures in patients with a confirmed diagnosis of COVID-19 or with uncertainty in unconfirmed cases. This article is a consensus document of the Interventional Cardiology Association and Heart Rhythm Association of the Spanish Society of Cardiology and aims to provide information to health care professionals working in these invasive cardiology facilities (cardiac catheterization and electrophysiology labs, pacemaker implantation) in order to guarantee quality patient care and adequate levels of infection prevention.

Background Early generation drug‐eluting stents (DESs) showed a high grade of coronary endothelial dysfunction that was attributed to lack of stent reendothelialization. Endothelium‐dependent vasomotor response of current DESs and bioresorbable scaffolds (BRSs) remains unknown. This study sought to assess the device‐related endothelial function of current devices and to correlate neointima healing with endothelial function. Methods and Results A total of 206 patients from 4 randomized trials treated with the durable‐polymer everolimus‐eluting Xience (n=44), bioresorbable‐polymer sirolimus‐eluting Orsiro (n=35), polymer‐free biolimus‐eluting Biofreedom (n=24), bioactive endothelial‐progenitor cell‐capturing sirolimus‐eluting Combo DES (n=25), polymer‐based everolimus‐eluting Absorb (n=44), and Mg‐based sirolimus‐eluting Magmaris BRS (n=34) underwent endothelium‐dependent vasomotor tests and optical coherence tomography imaging, as per protocol, at follow‐up. Crude vasomotor responses of distal segments to low‐dose acetylcholine (10−6 mol/L) were different between groups: bioresorbablepolymer DEShad the worst (−8.4%±12.6%) and durable‐polymer DES had the most physiologic (−0.4%±11.8%; P=0.014). High‐dose acetylcholine (10−4 mol/L) showed similar responses between groups (ranging from −10.8%±11.6% to −18.1%±15.4%; P=0.229). Device healing was different between devices. Uncovered struts ranged from 6.3%±7.1% (bioresorbable‐polymer DES) to 2.5%±4.5% (bioactive DES; P=0.056). In multivariate models, endothelium‐dependent vasomotor response was associated with age, bioresorbable‐polymer DES, and angiographic lumen loss, but not with strut coverage nor plaque type. Endothelial dysfunction (defined as ≥4% vasoconstriction) was observed in 46.6% of patients with low‐dose and 68.9% with high‐dose acetylcholine, without differences between groups. Conclusions At follow‐up, endothelial dysfunction was frequently observed in distal segments treated with current stents without remarkable differences between devices. Although neointima healing was different between devices, poor healing was not associated with endothelial dysfunction.

An 83-year-old man with significant background comorbidities was admitted with an inferior ST-segment elevation myocardial infarction. During primary percutaneous coronary intervention, a giant aneurysm is seen in the right coronary artery. (Level of Difficulty: Beginner.)

ABSTRACT Introduction and objectives: The PSP (pre-dilation, sizing and post-dilation) score, derived from the GHOST-EU registry, has evaluated the relationship between the implantation technique of bioresorbable scaffolds and the clinical outcomes. The objective was to perform an external validation of the PSP technique and to determine its effect on adverse cardiac events in various clinical and anatomical scenarios. Methods: Data from the REPARA registry (2230 patients) were used for external validation, whereas a common database combining REPARA and GHOST-EU (3250 patients) data was used to evaluate the effect of PSP technique in various clinical and anatomical scenarios. PSP-1 and PSP-3 were used to score the appropriateness of pre-dilation, scaffold sizing, and post-dilation. The primary endpoint was 1-year device-oriented composite endpoint of cardiac death, target-vessel myocardial infarction, and target-lesion revascularization. The definite/probable scaffold thrombosis according to the Academic Research Consortium criteria was also evaluated. Results: A total of 303 (18.2%) patients were treated with an optimal PSP-1, and 182 (8.2%) with an optimal PSP-3. The external validation showed that PSP has a very high negative predictive value for device-oriented composite endpoint and scaffold thrombosis (91.8% and 89.1% for PSP-1; 98.4% and 97.3% for PSP-3, respectively). Patients with an optimal PSP-3 had a numerically lower rate of device-oriented composite endpoint and scaffold thrombosis compared to those without it (0.5% vs 2.9%; P = .085 and 0.5% vs 1.8%; P = .248, respectively). In the merged database, PSP benefits were seen on many scenarios, except in the ST-segment elevation myocardial infarction where a trend towards no benefit of an optimal PSP technique was present (Pinteraction = .100). Conclusions: In the REPARA registry, at 1-year follow-up, an optimal PSP technique was not associated with a lower rate of device-oriented composite endpoint. Further research is necessary to assess the impact of the PSP technique in longer follow-ups.

RESUMEN Introducción y objetivos: La escala de puntuación PSP (pre-dilation, sizing and post-dilation), derivada del registro GHOST-EU, evalúa la relación entre la técnica de implante de los armazones bioabsorbibles y los resultados clínicos. El objetivo fue realizar una validación externa de la escala PSP y determinar su efecto en eventos adversos cardiacos en diversos escenarios clínicos y anatómicos. Métodos: Para la validación externa se emplearon los datos del registro REPARA (2.230 pacientes), mientras que se utilizó una base de datos común que combina datos de REPARA y GHOST-EU (3.250 pacientes) para evaluar el efecto de la técnica PSP en varios escenarios clínicos y anatómicos. Se usó PSP-1 y PSP-3 para calificar la calidad de la predilatación, el dimensionamiento de los armazones y la posdilatación. El objetivo primario fue la variable compuesta orientada al dispositivo (muerte cardiaca, infarto de miocardio del vaso diana y revascularización de la lesión diana) a 1 año. También se evaluó la trombosis definitiva o probable del armazón según los criterios del Academic Research Consortium. Resultados: Se trató a 303 (18,2%) pacientes con una PSP-1 óptima y a 182 (8,2%) con una PSP-3 óptima. La validación externa mostró que la escala PSP tiene un valor predictivo negativo muy alto para el objetivo primario compuesto orientado al dispositivo y la trombosis del armazón (91,8 y 89,1% para PSP-1; 98,4 y 97,3% para PSP-3, respectivamente). En pacientes con PSP-3 óptimo, el objetivo primario compuesto orientado al dispositivo y la trombosis del armazón fueron numéricamente inferiores en comparación con los pacientes sin PSP-3 óptimo (0,5 frente a 2,9%; p = 0,085; y 0,5 frente a 1,8%; p = 0,248, respectivamente). En la base de datos combinada, los beneficios de la escala PSP se observaron en diversos escenarios, excepto en el de infarto de miocardio con elevación del segmento ST, en el que se observó una tendencia hacia laausencia de beneficios de una técnica de PSP óptima (pinteracción = 0,100). Conclusiones: Una técnica de PSP óptima no se asoció con una tasa más baja del objetivo primario compuesto orientado al dispositivo. Se necesitan nuevos estudios para evaluar el impacto de la técnica de PSP con un seguimiento más prolongado.

MicroRNAs (miRNA) are major regulators of intercellular communication and key players in the pathophysiology of cardiovascular disease. This study aimed to determine the miRNA fingerprint in a cohort of 53 patients with acute myocardial infarction (AMI) with non-ST-segment elevation (NSTEMI) relative to miRNA expression in healthy controls (n = 51). miRNA expression was initially profiled by miRNA array in the serum of patients undergoing cardiac catheterization during NSTEMI (n = 8) and 1 year past the event (follow-up, n = 8) and validated in the entire cohort. In total, 58 miRNAs were differentially expressed during AMI (p < 0.05), while 36 were modified at follow-up (Fisher’s exact test: p = 0.0138). Enrichment analyses revealed differential regulation of biological processes by miRNA at each specific time point (AMI vs. follow-up). During AMI, the miRNA profile was associated mainly with processes involved in vascular development. However, 1 year after AMI, changes in miRNA expression were partially related to the regulation of cardiac tissue morphogenesis. Linear correlation analysis of miRNA with serum levels of cytokines and chemokines revealed that let-7g-5p, let-7e-5p, and miR-26a-5p expression was inversely associated with serum levels of pro-inflammatory cytokines TNF-α, and the chemokines MCP-3 and MDC. Transient transfection of human endothelial cells (HUVEC) with let-7e-5p inhibitor or mimic demonstrated a key role for this miRNA in endothelial function regulation in terms of cell adhesion and angiogenesis capacity. HUVEC transfected with let-7e-5p mimic showed a 20% increase in adhesion capacity, whereas transfection with let-7e-5p inhibitor increased the number of tube-like structures. This study pinpoints circulating miRNA expression fingerprint in NSTEMI patients, specific to the acute event and changes at 1-year follow-up. Additionally, given its involvement in modulating endothelial cell function and vascularization, altered let-7e-5p expression may constitute a therapeutic biomarker and target for ischemic heart disease.

BackgroundPatients presenting with the coronavirus-2019 disease (COVID-19) may have a high risk of cardiovascular adverse events, including death from cardiovascular causes. The long-term cardiovascular outcomes of these patients are entirely unknown. We aim to perform a registry of patients who have undergone a diagnostic nasopharyngeal swab for SARS-CoV-2 and to determine their long-term cardiovascular outcomes.Study and designThis is a multicenter, observational, retrospective registry to be conducted at 17 centers in Spain and Italy (ClinicalTrials.gov number: NCT04359927). Consecutive patients older than 18 years, who underwent a real-time reverse transcriptase-polymerase chain reaction (RT-PCR) for SARS-CoV2 in the participating institutions, will be included since March 2020, to August 2020. Patients will be classified into two groups, according to the results of the RT-PCR: COVID-19 positive or negative. The primary outcome will be cardiovascular mortality at 1 year. The secondary outcomes will be acute myocardial infarction, stroke, heart failure hospitalization, pulmonary embolism, and serious cardiac arrhythmias, at 1 year. Outcomes will be compared between the two groups. Events will be adjudicated by an independent clinical event committee.ConclusionThe results of this registry will contribute to a better understanding of the long-term cardiovascular implications of the COVID19.

The concurrent management of type 2 diabetes mellitus and heart failure presents several challenges and unmet clinical needs. The sodium-glucose cotransporter 2 inhibitors (SGLT2i) are new generation of oral hypoglycemic agents, they inhibit renal glucose reabsorption and increase renal glucose excretion, thus lowering plasma glucose levels and contributing to a modest reduction in HbA1C. In two pivotal randomized clinical trial, SGLT2i have showed a clinically important reduction in cardiovascular mortality and hospitalization due to heart failure. However, also important adverse effects such as increased risk of bone fractures and lower limb amputations were found. Currently, physiological mechanisms leading to cardiovascular benefits with SGLT2i are not completely understood, but it seems accepted that some of these benefits are related to non-glycemic effects. In this review, we analyze the available clinical evidence focusing in cardiovascular outcomes and heart failure, physiological mechanism of action, and comment on future directions of research.

COVID-19 has shown significant morbidity with the involvement of multiple systems, including the cardiovascular system. Cardiovascular manifestations in the acute phase can include myocardial injury itself, myocardial infarction, venous thromboembolic events, myocarditis, Takotsubo syndrome, and different arrhythmic events. Myocardial injury defined by the rise of cardiac biomarkers in blood has been found in multiple studies with a prevalence of about 20%. Its presence is related to worse clinical outcomes and in-hospital mortality. The mechanisms of myocardial injury have been the subject of intense research but still need to be clarified. The characterization of the cardiac affectation with echocardiography and cardiac magnetic resonance has found mixed results in different studies, with a striking incidence of imaging criteria for myocarditis. Regarding post-acute and chronic follow-up results, the persistence of symptoms and imaging changes in recovered COVID-19 patients has raised concerns about the duration and the possible significance of these findings. Even though the knowledge about this disease has increased incredibly in the last year, many aspects are still unclear and warrant further research.

The optimal antithrombotic strategy following left atrial appendage occlusion (LAAO) is not yet clearly established. Low-dose non-vitamin K antagonist oral anticoagulants (NOAC) might represent a valid alternative, but data regarding their usage is scarce. The aim of this study was to examine the efficacy and safety of low-dose NOAC compared to single (SAPT) or dual antiplatelet therapies (DAPT) after LAAO. We included consecutive patients with non-valvular atrial fibrillation who underwent LAAO and received low-dose apixaban, SAPT, or DAPT at discharge. The primary objective of this study included an efficacy endpoint (thromboembolic events and device related thrombosis (DRT)) and a safety endpoint (incidence of major bleeding) within the first three months after LAAO. A total of 139 patients were included. This group involved SAPT in 26 (18%), DAPT in 73 (53%), and apixaban in 40 (29%) patients. Follow-up at three-months showed no significant differences in the primary efficacy endpoint (2 (8%) SAPT, 3 (4%) DAPT and 0 (0%) apixaban; p value = 0.25). In contrast, the primary safety endpoint occurred more frequently in DAPT patients (7 (10%) DAPT, 0 (0%), SAPT and 0 with apixaban; p value = 0.03). Combining both efficacy and safety outcomes, low dose apixaban had a lower rate of events (2 (8%) with SAPT, 9 (12%) with DAPT and 0 (0%) with apixaban; p = 0.046). Low-dose apixaban after LAAO may be a valid alternative to DAPT and SAPT as depicted by the reduction in the occurrence of major bleedings and combined DRT/major bleedings respectively. Randomized data will be necessary to validate this strategy.

Transcatheter tricuspid valve repair (TTVr) has emerged as an alternative for the treatment of severe tricuspid regurgitation (TR). We report our initial experience with an edge-to-edge TTVr system in a high-volume institution. Methods: We included consecutive patients who underwent edge-to-edge TTVr systems. The primary efficacy endpoint was a reduction in the TR of at least one grade. The primary safety endpoint was procedure-related clinical serious adverse events. Results: A total of 28 patients underwent TTVr with edge-to-edge systems. All patients presented with at least severe TR with a high impact on quality of life (82% of patients in NYHA class ≥ III). The Triclip system was the most used device (89%). The primary efficacy endpoint was met in all patients. Only one patient experienced a procedural complication (femoral pseudoaneurysm). At three-month follow-up, 83% of patients were in NYHA I or II (18% baseline vs. 83% 3 months follow-up; p < 0.001). Echocardiography follow-up showed residual TR ≤ 2 in 79% of patients (paired p < 0.001). At the maximum follow-up (median follow up = 372 days), no patients had died. Conclusions: Edge-to-edge TTVr systems seem to represent a very valid alternative to prevent morbidity and mortality associated with TR as depicted by the favorable efficacy and safety.

Myocardial infarction remains the principal cause of death in Europe. In patients with ST-segment-elevation myocardial infarction (STEMI), a promptly revascularization with primary percutaneous intervention (PCI) has transformed prognosis in the last decades. However, despite increasing successful PCI procedures, mortality has remained unchanged in recent years. Also, due to an unsatisfactory reperfusion, some patients have significant myocardial damage and suffer left ventricular adverse remodeling with reduced function—all that resulting in the onset of heart failure with all its inherent clinical and socioeconomic burden. As a consequence of longer ischemic times, distal thrombotic embolization, ischemia-reperfusion injury and microvascular dysfunction, the resultant myocardial infarct size is the major prognostic determinant in STEMI patients. The improved understanding of all the pathophysiology underlying these events has derived to the development of several novel therapies aiming to reduce infarct size and to improve clinical outcomes in these patients. In this article, based on the mechanisms involved in myocardial infarction prognosis, we review the new interventional strategies beyond stenting that may solve the suboptimal results that STEMI patients still experience.

The exact mechanisms leading to myocardial injury in the coronavirus disease 2019 (COVID-19) are still unknown. In this retrospective observational study, we include all consecutive COVID-19 patients admitted to our center. They were divided into two groups according to the presence of myocardial injury. Clinical variables, Charlson Comorbidity Index (CCI), C-reactive protein (CRP), CAC (COVID-19-associated coagulopathy), defined according to the ISTH score, treatment and in-hospital events were collected. Between March and April 2020, 331 COVID-19 patients were enrolled, 72 of them (21.8%) with myocardial injury. Patients with myocardial injury showed a higher CCI score (median (interquartile range), 5 (4–7) vs. 2 (1–4), p = 0.001), higher CRP values (18.3 (9.6–25.9) mg/dL vs. 12.0 (5.4–19.4) mg/dL, p ˂ 0.001) and CAC score (1 (0–2) vs. 0 (0–1), p = 0.001), and had lower use of any anticoagulant (57 patients (82.6%) vs. 229 patients (90.9%), p = 0.078), than those without. In the adjusted logistic regression, CRP, myocardial injury, CCI and CAC score were positive independent predictors of mortality, whereas anticoagulants resulted as a protective factor. Myocardial injury in COVID-19 patients is associated with inflammation and coagulopathy, resulting in a worse in-hospital prognosis. Treatment with anticoagulant agents may help to improve in-hospital outcomes.

Hypertrophic cardiomyopathy (HCM) can cause symptoms due to the obstruction of the left ventricle outflow tract (LVOT). Although pharmacological therapy is the first step for treating this condition, many patients do not fully respond to the treatment, and an invasive approach is required to manage symptoms. Septal reduction therapies include septal myectomy (SM) and alcohol septal ablation (ASA). ASA consists of a selective infusion of high-grade alcohol into a septal branch supplying the basal interventricular septum to create an iatrogenic infarction with the aim of reducing LVOT obstruction. Currently, SM and ASA have the same level of indication; however, ASA is normally reserved for patients of advanced age, with comorbidities or when the surgical approach is not feasible. Recent data suggests that there are no differences in short- and long-term all-cause mortality, cardiovascular mortality and sudden cardiac death between ASA and SM. Despite the greater experience and refinement of the technique gained in recent years, the most common complication continues to be complete atrio-ventricular block, requiring a permanent pacemaker. Septal reduction therapies should be performed in experienced centres with comprehensive programs.

MicroRNAs (miRNAs) are small non-coding RNAs that regulate gene expression at the post-transcriptional level. Through specific base pairing with their targets messenger RNAs (mRNA), miRNA can modify cell phenotype and function. Several miRNAs are aberrantly expressed in diseased arteries and may influence different features of vascular remodeling, including neointimal formation and diminished re-endothelialization. This review will discuss the clinical implications of miRNAs in the field of vascular remodeling and their potential role as diagnostic and therapeutic tools. miRNA modulation offers a promising strategy for therapeutic intervention to inhibit smooth muscle cell proliferation and enhance endothelial regeneration after percutaneous coronary intervention (PCI) in order to reduce restenosis and late thrombosis.

BACKGROUND:Use of everolimus-eluting stents (EES) has proven to be clinically effective and safe in patients with ST-segment elevation myocardial infarction but it remains unclear whether it is cost-effective compared to bare-metal stents (BMS) in the long-term. We sought to assess the cost-effectiveness of EES versus BMS based on the 5-year results of the EXAMINATION trial, from a Spanish health service perspective. METHODS:Decision analysis of the use of EES versus BMS was based on the patient-level clinical outcome data of the EXAMINATION trial. The analysis adopted a lifelong time horizon, assuming that long-term survival was independent of the initial treatment strategy after the end of follow-up. Life-expectancy, health-state utility scores and unit costs were extracted from published literature and publicly available sources. Non-parametric bootstrapping was combined with probabilistic sensitivity analysis to co-assess the impact of patient-level variation and parameter uncertainty. The main outcomes were total costs and quality-adjusted life-years. The incremental cost-effectiveness ratio was expressed as cost per quality-adjusted life-years gained. Costs and effects were discounted at 3%. RESULTS:The model predicted an average survival time in patients receiving EES and BMS of 10.52 and 10.38 undiscounted years, respectively. Over the life-long time horizon, the EES strategy was €430 more costly than BMS (€8,305 vs. €7,874), but went along with incremental gains of 0.10 quality-adjusted life-years. This resulted in an average incremental cost-effectiveness ratio over all simulations of €3,948 per quality-adjusted life-years gained and was below a willingness-to-pay threshold of €25,000 per quality-adjusted life-years gained in 86.9% of simulation runs. CONCLUSIONS:Despite higher total costs relative to BMS, EES appeared to be a cost-effective therapy for ST-segment elevation myocardial infarction patients due to their incremental effectiveness. Predicted incremental cost-effectiveness ratios were below generally acceptable threshold values.

Aortic stenosis is highly prevalent in the elderly, when symptomatic, is associated with high mortality. Although its treatment is mainly surgical, cumulative evidence has demonstrated that transcatheter aortic valve implantation is an effective and safe treatment option for selected patients, especially for inoperable and high-risk patients. The aim of this review is to discuss the advances in current and emergent devices, with special focus on clinical and safety outcomes in randomized clinical trials and registries.

Bioresorbable scaffolds (BRS) were introduced in clinical practice to overcome the long-term limitations of newer-generation drug-eluting stents. Despite some initial promising results of the Absorb BRS, safety concerns have led to the discontinuation of the commercialization of this device. Several retrospective studies have assessed the impact of the so-called Pre-dilation, Sizing and Post-dilation (PSP) technique concluding that an optimal PSP technique can improve clinical outcomes following BRS implantation. In this article, the definition of the PSP technique, and the current evidence of its impact on clinical outcomes are put in perspective. Additionality, the relationship between the PSP technique and the dual-antiplatelet therapy to prevent scaffold thrombosis is addressed. Finally, the future perspectives of BRS technology in clinical practice are commented.

Clarissa Cola1, Salvatore Brugaletta1, Victoria Martín Yuste1, Bieito Campos1, Dominick J Angiolillo2, Manel Sabaté11Interventional Cardiology Unit, Department of Cardiology, Sant Pau University Hospital, Barcelona, Spain; 2Interventional Cardiology Unit, Shands Jacksonville, University of Florida, Florida, USAAbstract: Coronary stent thrombosis is a serious problem in the drug-eluting stent era. Despite aggressive antiplatelet therapy during and after percutaneous coronary intervention (PCI), the incidence of sub-acute stent thrombosis remains approximately 0.5%–2%, which may represent a catastrophic clinical situation. Both procedural factors and discontinuation of antiplatelet therapy are normally associated with this event. We report on simultaneous stent thromboses of two drug-eluting stents implanted in two different vessels, which resulted in a life-threatening clinical condition. Possible contributing factors that led to synergistic thrombotic effects are discussed.Keywords: diabetes mellitus, platelet function, antiplatelet therapy, drug-eluting stent, stent thrombosis

BackgroundOur interest in chronic conditions is due to the fact that, worldwide, chronic diseases have overtaken infectious diseases as the leading cause of death and disability, so their management represents an important challenge for health systems. The aim of this study was to compare the performance of primary health care services in managing diabetes, congestive heart failure (CHF) and coronary heart disease (CHD), by age group.MethodsThis population-based retrospective cohort study was conducted in Italy, enrolling 1,948,622 residents ≥ 16 years old. A multilevel regression model was applied to analyze compliance to care processes with explanatory variables at both patient and district level, using age group as an independent variable, and adjusting for sex, citizenship, disease duration, and Charlson index on the first level, and for District Health Unit on the second level.ResultsThe quality of chronic disease management showed an inverted U-shaped relationship with age. In particular, our findings indicate lower levels for young adults (16-44 year-olds), adults (45-64), and oldest old (+85) than for patients aged 65-74 in almost all quality indicators of CHD, CHF and diabetes management. Young adults (16-44 y), adults (45-64 y), the very old (75-84 y) and the oldest old (+85 y) patients with CHD, CHF and diabetes are less likely than 65-74 year-old patients to be monitored and treated using evidence-based therapies, with the exceptions of echocardiographic monitoring for CHF in young adult patients, and renal monitoring for CHF and diabetes in the very old.ConclusionOur study shows that more effort is needed to ensure that primary health care systems are sensitive to chronic conditions in the young and in the very elderly.

BACKGROUND: Italy has a population of 60 million and a universal coverage single-payer healthcare system, which mandates collection of healthcare administrative data in a uniform fashion throughout the country. On the other hand, organization of the health system takes place at the regional level, and local initiatives generate natural experiments. This is happening in particular in primary care, due to the need to face the growing burden of chronic diseases. Health services research can compare and evaluate local initiatives on the basis of the common healthcare administrative data.However reliability of such data in this context needs to be assessed, especially when comparing different regions of the country. In this paper we investigated the validity of healthcare administrative databases to compute indicators of compliance with standards of care for diabetes, ischaemic heart disease (IHD) and heart failure (HF). METHODS: We compared indicators estimated from healthcare administrative data collected by Local Health Authorities in five Italian regions with corresponding estimates from clinical data collected by General Practitioners (GPs). Four indicators of diagnostic follow-up (two for diabetes, one for IHD and one for HF) and four indicators of appropriate therapy (two each for IHD and HF) were considered. RESULTS: Agreement between the two data sources was very good, except for indicators of laboratory diagnostic follow-up in one region and for the indicator of bioimaging diagnostic follow-up in all regions, where measurement with administrative data underestimated quality. CONCLUSION: According to evidence presented in this study, estimating compliance with standards of care for diabetes, ischaemic heart disease and heart failure from healthcare databases is likely to produce reliable results, even though completeness of data on diagnostic procedures should be assessed first. Performing studies comparing regions using such indicators as outcomes is a promising development with potential to improve quality governance in the Italian healthcare system.

Gastrointestinal bleeding of obscure origin or with an intractable cause is particularly common in patients with atrial fibrillation subject to oral anticoagulant therapy. This condition is highly recurrent and therefore gives rise to high morbidity and mortality rates, thus entailing a vicious cycle that is difficult to solve. Percutaneous left atrial appendage closure has become a therapeutic alternative for patients with atrial fibrillation and a contraindication for oral anticoagulation. This technique would allow the discontinuation of oral anticoagulants, thus helping to reduce the risk for gastrointestinal bleeding, and would also be protective against embolic events in this group of patients, thereby eventually breaking this vicious cycle. We report our experience with percutaneous left atrial appendage closure in the management of patients with atrial fibrillation who are subject to oral anticoagulation therapy and suffer from obscure or intractable gastrointestinal bleeding.