Valor predictivo de la puntuación SYNTAX en la lesión vascular culpable y no culpable. Respuesta

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"Assessment of effectiveness and security in high pressure postdilatation of bioresorbable vascular scaffolds during percutaneous coronary intervention. Study in a contemporary, non-selected cohort of Spanish patients"

OBJECTIVES: To determine security and benefits of high pressure postdilatation (HPP) of bioresorbable vascular scaffolds (BVS) in percutaneous coronary intervention (PCI) of complex lesions whatever its indication is. BACKGROUND: Acute scaffold disruption has been proposed as the main limitation of BVS when they are overexpanded. However, clinical implications of this disarray are not yet clear and more evidence is needed. METHODS: A total of 25 BVS were deployed during PCI of 14 complex lesions after mandatory predilatation. In all cases HPP was performed with NC balloon in a 1:1 relation to the artery. After that, optical coherence tomography (OCT) analyses were performed. RESULTS: Mean and maximal postdilatation pressure were 17±3.80 and 20 atmospheres (atm) respectively. Postdilatation balloon/scaffold diameter ratio was 1.01. A total of 39,590 struts were analyzed. Mean, minimal and maximal scaffold diameter were respectively: 3.09±0.34mm, 2.88±0.31mm and 3.31±0.40mm. Mean eccentricity index was 0.13±0.05. ISA percentage was 1.42% with a total of 564 malapposed struts. 89 struts were identified as disrupted, which represents a percentage of disrupted struts of 0.22%. At 30days, none of our patients died, suffered from stroke, stent thrombosis or needed target lesion revascularization (TLR). CONCLUSIONS: NC balloon HPP of BVS at more than 17atm (up to 20atm) is safe during PCI and allows to achieve better angiographic and clinical results

Litotricia intracoronaria en pacientes de la vida real: Primera experiencia en lesiones complejas y gravemente calcificadas

Introduction and objectives: Complex calcified lesions can affect stent expansion and lead to stent failure and adverse outcomes. Intracoronary lithotripsy (ICL) has emerged as a new tool that enables calcium modification. The Disrupt CAD II clinical trial has recently evaluated the safety and feasibility of ICL in patients with stable coronary disease and calcified coronary lesions. Although its use has increased rapidly, the experience already reported with this new device is limited. We report the results in real-life complex patients with heavy coronary calcification. Methods: From October 2018 to March 2019, 25 patients (37 calcified lesions) were treated in 2 Spanish centers, which accounted for 2.7% of the patients treated with percutaneous coronary intervention. Results: The device and clinical success rates were 84% and 95%, respectively. No procedure-related complications were seen. The crossing rate of the ICL balloon was 100% and balloon rupture during inflation occurred in 8%. The ICL was performed in a subset of highly complex lesions like left main coronary artery lesions and chronic total coronary occlusions. Compared to the Disrupt CAD II trial, our patients were younger but their clinical scenario was worse with a higher prevalence of diabetes (68%), renal failure (22%), and up to 76% suffered from acute coronary syndrome. The ICL failed to reach proper expansion in 3 out of 4 cases of stent underexpansion. The procedure was performed safely, and clinical and device success were high with no in-hospital mortality. One patient died of non-cardiac causes at the 30-day follow-up. Conclusions: The ICL-assisted percutaneous coronary intervention was performed safely and effectively in a real-life cohort of patients with calcified and highly complex lesions.Introducción y objetivos: Las lesiones coronarias calcificadas pueden impedir una correcta expansión del stent que en ocasiones conduce a eventos adversos. La litotricia intracoronaria es una nueva herramienta de modificación de la placa, cuyas seguridad y viabilidad en pacientes con enfermedad coronaria estable han sido evaluadas en el ensayo Disrupt CAD II. Aunque su uso ha aumentado rápidamente, hasta el momento solo se han comunicado casos aislados en escenarios concretos. Se presentan los resultados en pacientes clínicamente complejos de la vida real con calcificación coronaria grave. Métodos: Entre octubre de 2018 y marzo de 2019 se trató a 25 pacientes (37 lesiones) en 2 centros españoles, lo que representa el 2,7% de los pacientes tratados con intervención coronaria percutánea. Resultados: Las tasas de éxito clínico y del dispositivo fueron del 84 y el 95%, y no se observaron complicaciones relacionadas con el procedimiento. En todos los casos se consiguió cruzar la lesión con el balón de litotricia intracoronaria, si bien en el 8% de los casos se rompió el balón durante el inflado. Se trataron con éxito lesiones complejas, como oclusiones coronarias totales y estenosis del tronco común. En comparación con el estudio Disrupt CAD II, nuestros pacientes eran más jóvenes, pero tenían peor escenario clínico, con mayor prevalencia de diabetes (68%) e insuficiencia renal (22%), y hasta el 76% se presentó como síndrome coronario agudo. En 3 de 4 pacientes con infraexpansión de stent tratados con litotricia intracoronaria no se consiguió una expansión adecuada tras el procedimiento. No hubo complicaciones ni mortalidad hospitalaria. Un paciente falleció por causa no cardiaca a los 30 días de seguimiento. Conclusiones: La litotricia intracoronaria se ha demostrado efectiva y segura en una cohorte de pacientes complejos de la vida real con lesiones calcificadas

Comparison of balloon-expandable vs. self-expandable valves in patients undergoing transfemoral transcatheter aortic valve implantation: From the CENTER-collaboration

Aims: The aim of this study was to compare clinical outcomes of patients undergoing transfemoral transcatheter aortic valve implantation (TAVI) with balloon-expandable (BE) valves vs. self-expandable (SE) valves. Transcatheter aortic valve implantation is a minimally invasive and lifesaving treatment in patients with aortic valve stenosis. Even though BE-valves and SE-valves are both commonly used on a large scale, adequately sized trials comparing clinical outcomes in patients with severe aortic valve stenosis treated with BE-valves compared with SE-valves are lacking. Methods and results: In this CENTER-collaboration, data from 10 registries or clinical trials, selected through a systematic search, were pooled and analysed. Propensity score methodology was used to reduce treatment selection bias and potential confounding. The primary endpoints were mortality and stroke at 30 days follow-up in patients treated with BE-valves compared with SE-valves. Secondary endpoints included clinical outcomes, e.g. bleeding during hospital admission. All outcomes were split for early-generation BE-valves compared with early-generation SE-valves and new-generation BE-valves with new-generation SE-valves. The overall patient population (N = 12 381) included 6239 patients undergoing TAVI with BE-valves and 6142 patients with SE-valves. The propensity matched population had a mean age of 81 +/- 7 years and a median STS-PROM score or 6.5% [interquartile range (IQR) 4.0-13.0%]. At 30-day follow-up, the mortality rate was not statistically different in patients undergoing TAVI with BE-valves compared with SE-valves [BE: 5.3% vs. SE: 6.2%, relative risk (RR) 0.9; 95% confidence interval (CI) 0.7-1.0, P = 0.10]. Stroke occurred less frequently in patients treated with BE-valves (BE: 1.9% vs. SE: 2.6%, RR 0.7; 95% CI 0.5-1.0, P = 0.03). Also, patients treated with BE-valves had a three-fold lower risk of requiring pacemaker implantation (BE: 7.8% vs. SE: 20.3%, RR 0.4; 95% CI 0.3-0.4, P < 0.001). In contrast, patients treated with new-generation BE-valves more frequently experienced major and life-threatening bleedings compared with new-generation SE-valves (BE: 4.8% vs. SE: 2.1%, RR 2.3; 95% CI 1.6-3.3, P < 0.001). Conclusion: In this study, which is the largest study to compare valve types in TAVI, we demonstrated that the incidence of stroke and pacemaker implantation was lower in patients undergoing transfemoral TAVI with BE-valves compared with SE-valves. In contrast, patients treated with new-generation BE-valves more often suffered from major or life-threatening bleedings than patients with new-generation SE-valves. Mortality at 30-days was not statistically different in patients treated with BE-valves compared with SE-valves. This study was a propensity-matched analysis generated from observational data, accordingly current outcomes will have to be confirmed in a large scale randomized controlled trial