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

Comparative Evaluation of Local and Downstream Responses in Two Commercially Available Paclitaxel-Coated Balloons in Healthy Peripheral Arteries of a Swine Model

[EN] Objective To investigate the local, downstream, and systemic effects of two different paclitaxel-coated balloons. Design Preclinical study in healthy peripheral arteries of a swine model, with randomized allocation of the distribution of the devices: the test paclitaxel-coated balloon (PCB) (Luminor®), a control PCB (IN.PACT®), and a plain angioplasty balloon (Oceanus®), considering single (1×) and overlapping (3×) doses with simple blind histologic analysis. Methods Twenty animals underwent balloon angioplasty at 1× or 3× doses in the external and internal branches of both femoral arteries and were followed-up for 28 days. Post-procedural and follow-up angiography were carried out. Comprehensive necropsy and histology were used to evaluate the local, downstream and systemic effects. Results Angioplasty was successfully carried out in all animals. Significant protocol deviations appeared in three arteries (treated with Oceanus®) without clinical relevance. Those samples were excluded from the analysis. All the animals survived the follow-up period without major clinical issues. Local signs of drug toxicity were less marked with Luminor® than IN.PACT® at 1× dose, including endothelial loss (p=0.0828), intima/media inflammation (p=0.0004), transmural medial smooth muscle cell (SMC) loss (p=0.0016), wall thickness loss (p=0.0141), presence of fibrin in the vascular wall (p=0.0054), and adventitial inflammation (p=0.0080). A similar pattern was observed at the 3× dose for endothelial loss (p=0.0011), intima/media inflammation (p< 0.0001), circumferential SMC loss (p=0.0004), medial SMC replacement with proteoglycans (p=0.0014), fibrin (p=0.0034), and collagen content (p=0.0205). Downstream vascular 4 histologic changes were mild although more prevalent in the IN.PACT® 3× group (p=0.006). No systemic effects of toxicity were detected in any of the samples analyzed. Conclusion Luminor® showed better healing pattern (lower inflammation, and endothelial and muscular loss) than IN.PACT® balloon. The effect was evident at single and triple doses. The prevalence of downstream lesions, albeit low, was higher with the triple dose of IN.PACT® compared with Luminor®.S

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

The Usefulness of Coregistration with iFR in Tandem or Long Diffuse Coronary Lesions: The iLARDI Randomized Clinical Trial

Background. Despite technical advancements, patients with sequential or diffuse coronary lesions undergoing percutaneous coronary intervention (PCI) have an increased risk of cardiovascular events at follow-up. We aimed to analyze the utility of a SyncVision/iFR (S-iFR)-guided PCI strategy versus an angiography-guided strategy in patients with this type of lesions. Methods. Randomized, multicenter, controlled, and open-label trial to compare S-iFR versus angiography-guided PCI in patients with sequential or diffuse angiographic coronary stenosis (ClinicalTrials.gov identifier: NCT04283734). The primary endpoint was the implanted stent length. The main secondary endpoint was targeting vessel failure (TVF) at one year. Results. A total of 100 patients underwent randomization, with 49 patients assigned to the S-iFR group and 51 to the angiography-guided PCI group. There were no differences between groups regarding clinical and anatomical characteristics. The baseline iFR was 0.71 } 0.16 vs. 0.67 } 0.19 (p = 0.279) in the S-iFR and angiography group, respectively. The mean lesion length was 42.3 } 12 mm and 39.8 } 12 (p = 0.297). The implanted stent length was 32.7 } 17.2 mm in the S-iFR group and 43.1 } 14.9 mm in the angiography group (mean difference, −10.4 mm; 95% confidence interval [CI], −16.9 to −4.0; p = 0.002). At one year, target vessel failure (TVF) occurred in four patients: three (6.1%) in the S-iFR group vs. one (1.9%) in the angiography group (p = 0.319). Conclusions. Among patients with sequential or long diffuse coronary lesions, a S-iFR-guided PCI strategy resulted in a reduction of the total stent length compared to an angiography-guided PCI strategy. A nonsignificant increase in TVF was observed in the S-iFR group

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

Validation of quantitative flow ratio-derived virtual angioplasty with post-angioplasty fractional flow reserve—the QIMERA-I study

Producción CientíficaBackground: Quantitative flow ratio (QFR) virtual angioplasty with pre-PCI residual QFR showed better results compared with an angiographic approach to assess post-PCI functional results. However, correlation with pre-PCI residual QFR and post-PCI fractional flow reserve (FFR) is lacking. Methods: A multicenter prospective study including consecutive patients with angiographically 50–90% coronary lesions and positive QFR results. All patients were evaluated with QFR, hyperemic and non-hyperemic pressure ratios (NHPR) before and after the index PCI. Pre-PCI residual QFR (virtual angioplasty) was calculated and compared with post-PCI fractional flow reserve (FFR), QFR and NHPR. Results: A total of 84 patients with 92 treated coronary lesions were included, with a mean age of 65.5 ± 10.9 years and 59% of single vessel lesions being the left anterior descending artery in 69%. The mean vessel diameter was 2.82 ± 0.41 mm. Procedural success was achieved in all cases, with a mean number of implanted stents of 1.17 ± 0.46. The baseline QFR value was 0.69 ± 0.12 and baseline FFR and NHPR were 0.73 ± 0.08 and 0.82 ± 0.11, respectively. Mean post-PCI FFR increased to 0.87 ± 0.05 whereas residual QFR had been estimated as 0.95 ± 0.05, showing poor correlation with post-PCI FFR (0.163; 95% CI:0.078–0.386) and low diagnostic accuracy (30.9%, 95% CI:20–43%). Conclusions: In this analysis, the results of QFR-based virtual angioplasty did not seem to accurately correlate with post-PCI FFR

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