Respuesta vascular al uso de distintos dispositivos de tratamiento de la enfermedad coronaria en el modelo animal porcino = Vascular response to different devices for the treatment of coronary artery disease in a porcine model

274 p.El desarrollo de los stents farmacoactivos (SFA) ha abolido virtualmente la aparición de reestenosis al precio de una reparación vascular retrasada y/o defectuosa, que puede traducirse clínicamente en complicaciones como la trombosis tardía del stent. La investigación preclínica, clásicamente dirigida al análisis de la eficacia de los nuevos dispositivos, debe ahora reenfocarse en aspectos de seguridad para evitar complicaciones clínicas imprevistas. El análisis histopatológico de las arterias tratadas con stent debe ser realizado sistemáticamente, midiendo y caracterizando el daño arterial, la inflamación, endotelización, depósito de fibrina y otras variables que pueden ser indicativas de reparación vascular retrasada. Aunque el procedimiento histológico sigue siendo el método de referencia en el análisis de la respuesta vascular, son varias las técnicas de imagen que pueden ofrecer información valiosa en el estudio del proceso reparativo en puntos intermedio

Percutaneous Treatment of Mitral and Tricuspid Regurgitation in Heart Failure

Heart failure has become a real epidemic condition related to poor outcomes despite advances in medical therapies. Prevalence of significant mitral and/or tricuspid regurgitation is high in patients with advanced heart failure. Novel transcatheter techniques have recently emerged as a minimally invasive alternative in patients deemed high-risk for surgery or inoperable. Among them, MitraClip® system is thus far the first device that received regulatory approval and gained widespread clinical application, especially in patients with functional mitral regurgitation. Furthermore, first experiences with new devices for percutaneous mitral and tricuspid valves repair, and transcatheter mitral valve prosthesis have been increasingly reported. Percutaneous therapies for valvular heart disease have therefore become one of the most promising fields in the present and future of interventional cardiology and heart failure

Multi-state models for survival analysis in cardiology: an alternative to composite endpoints

[ES] En los estudios longitudinales en cardiología, el objetivo principal suele ser el tiempo hasta ciertos eventos adversos (EA), con el objetivo de identificar factores de riesgo o la eficacia de un tratamiento. Tradicionalmente se han empleado los composite endpoints, en concreto los EA cardiovasculares mayores (MACE) en sus diferentes versiones, que presentan la gran ventaja de aumentar la potencia de los estudios y de simplificar el análisis, pero dificultan la interpretación de los resultados y además presentan otras limitaciones, como otorgar el mismo peso a cada evento o utilizar únicamente la información sobre el primer evento. Por ello, en los últimos años ha crecido la preocupación por la actualización de estos métodos. El problema de analizar datos de estudios longitudinales con varios EA de interés se presta de manera natural a ser abordado con modelos multiestado, ya que permiten plantear modelos con una estructura compleja de relaciones entre la aparición de los diferentes eventos teniendo en cuenta todos los datos disponibles para cada paciente, además de proporcionar información sobre el tiempo esperado y la probabilidad de aparición de cada EA, estableciendo su dependencia de los factores de riesgo o de las características del tratamiento. Las principales ventajas de los modelos multiestado frente a otros modelos habitualmente utilizados se resumen en la tabla 1.SIEl presente trabajo ha sido financiado por la Universidad de León (código 2020/00153/001, 2020) y por el MINECO (PID2019-104790GB-I00, 2020).Ministerio de Economía, Comercio y Empres

Development and Evaluation of a Disease Large Animal Model for Preclinical Assessment of Renal Denervation Therapies

[EN] New-generation catheters-based renal denervation (RDN) is under investigation for the treatment of uncontrolled hypertension (HTN). We assessed the feasibility of a large animal model of HTN to accommodate the human RDN devices. Ten minipigs were instrumented to measure blood pressure (BP) in an awake-state. HTN was induced with subcutaneous 11-deoxycorticosterone (DOCA, 100 mg/kg) implants. Five months after, the surviving animals underwent RDN with the Symplicity® system. Norepinephrine (NE) renal gradients were determined before and 1 month after RDN. Renal arteries were processed for histological (hematoxylin-eosin, Movat pentachrome) and immunohistochemical (S100, tyrosine-hydroxylase) analyses. BP significantly rose after DOCA implants. Six animals died prematurely, mainly from infectious causes. The surviving animals showed stable BP levels after 5 months. One month after RDN, nerve damage was showed in three animals, with impedance drop >10%, NE gradient drop and reduction in BP. The fourth animal showed no nerve damage, impedance drop <10%, NE gradient increase and no change in BP. In conclusion, the minipig model of DOCA-induced HTN is feasible, showing durable effects. High mortality should be addressed in next iterations of this model. RDN may partially offset the DOCA-induced HTN. Impedance drop and NE renal gradient could be markers of RDN success.SIThis research was funded by Consejería de Salud, Junta de Castilla and Leon, Spain, the Grant GRS 1001/A/2014.We want to thank Medtronic Iberia for the donation of the Symplicity catheters used in this experiment

Percutaneous Treatment of Tricuspid Regurgitation

Tricuspid valve regurgitation is one of the most common valvular disorders and moderate to severe tricuspid regurgitation is consistently associated to an increased morbidity and mortality. From an etiopathological perspective, tricuspid regurgitation can be classified in primary, due to the organic disease of any of the valve components, or secondary, as a result of tricuspid valve annulus dilatation, adverse right ventricular remodeling and tricuspid valve leaflet tethering. Despite its poor prognosis, most patients with tricuspid insufficiency are managed conservatively and only those with concomitant left heart valvular disease do finally go surgery in the real-world setting. In fact, outcomes of conventional surgery in patients with isolated tricuspid regurgitation are poor and this approach has not proven yet any survival benefit over stand-alone medical therapy. Given this unmet need, new transcatheter techniques have been developed in the last years, including leaflet plication, percutaneous annuloplasty and valve implantation in either the tricuspid position (orthotopic implantation) or in a different position such as the vena cava (heterotopic implantation). These techniques, with promising outcomes, are seen as an interesting alternative to open-heart surgery given the much lower periprocedural risk

Regional differences in STEMI care in Spain. Data from the ACI-SEC Infarction Code Registry

Introduction and objectives: Geographical and organizational differences between different autonomous communities (AC) can generate differences in care for ST-segment elevation myocardial infarction (STEMI). A total of 17 heart attack code programs have been compared in terms of incidence rate, clinical characteristics, reperfusion therapy, delay to reperfusion, and 30-day mortality. Methods: National prospective observational study (83 centers included in 17 infarction networks). The recruitment period was 3 months (April 1 to June 30, 2019) with clinical follow-up at 30 days. Results: 4366 patients with STEMI were included. The incidence rate was variable between different AC (P <.0001), as was gender (P =.003) and the prevalence of cardiovascular risk factors (P <.0001). Reperfusion treatment was primary angioplasty (range 77.5%-97.8%), fibrinolysis ( range 0%-12.9%) or no treatment (range 2.2%- 13.5%). The analysis of the delay to reperfusion showed significant differences (P <.001) for all the intervals analyzed. There were significant differences in 30-days mortality that disappeared after adjusting for clinical and healthcare network characteristics. Conclusions: Large differences in STEMI care have been detected between the different AC, in terms of incidence rate, clinical characteristics, reperfusion treatment, delay until reperfusion, and 30-day mortality. The differences in mortality disappeared after adjusting for the characteristics of the patient and the care network

Long-term effects of coronavirus disease 2019 on the cardiovascular system, CV COVID registry: A structured summary of a study protocol

Background: Patients 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 design: This 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. Conclusion: The results of this registry will contribute to a better understanding of the long-term cardiovascular implications of the COVID19

Instantaneous Wave-Free Ratio for the Assessment of Intermediate Left Main Coronary Artery Stenosis: Correlations With Fractional Flow Reserve/Intravascular Ultrasound and Prognostic Implications: The iLITRO-EPIC07 Study

Background: There is little information available on agreement between fractional flow reserve (FFR) and instantaneous wave-free ratio (iFR) in left main coronary artery (LMCA) intermediate stenosis. Besides, several meta-analyses support the use of FFR to guide LMCA revascularization, but limited information is available on iFR in this setting. Our aims were to establish the concordance between FFR and iFR in intermediate LMCA lesions, to evaluate with intravascular ultrasound (IVUS) in cases of FFR/iFR discordance, and to prospectively validate the safety of deferring revascularization based on a hybrid decision-making strategy combining iFR and IVUS. Methods: Prospective, observational, multicenter registry with 300 consecutive patients with intermediate LMCA stenosis who underwent FFR and iFR and, in case of discordance, IVUS and minimal lumen area measurements. Primary clinical end point was a composite of cardiovascular death, LMCA lesion-related nonfatal myocardial infarction, or unplanned LMCA revascularization. Results: FFR and iFR had an agreement of 80% (both positive in 67 and both negative in 167 patients); in case of disagreement (31 FFR+/iFR- and 29 FFR-/iFR+) minimal lumen area was & GE;6 mm(2) in 8.7% of patients with FFR+ and 14.6% with iFR+. Among the 300 patients, 105 (35%) underwent revascularization and 181 (60%) were deferred according to iFR and IVUS. At a median follow-up of 20 months, major adverse cardiac events incidence was 8.3% in the defer group and 13.3% in the revascularization group (hazard ratio, 0.71 [95% CI 0.30-1.72]; P=0.45). Conclusions: In patients with intermediate LMCA stenosis, a physiology-guided treatment decision is feasible either with FFR or iFR with moderate concordance between both indices. In case of disagreement, the use of IVUS may be useful to indicate revascularization. Deferral of revascularization based on iFR appears to be safe in terms of major adverse cardiac events

Impact of operatoŕs experience on peri-procedural outcomes with Watchman FLX: Insights from the FLX-SPA registry

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

Rationale and design of the Concordance study between FFR and iFR for the assessment of lesions in the left main coronary artery. The ILITRO-EPIC-07 Trial

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), an intravascular echocardiography will be performed and revascularization will be delayed if the minimum lumen area is > 6 mm(2). 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