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BACKGROUND The role of direct oral anticoagulants as compared with vitamin K antagonists for atrial fibrillation after successful transcatheter aortic-valve replacement (TAVR) has not been well studied. METHODS We conducted a multicenter, prospective, randomized, open-label, adjudicator-masked trial comparing edoxaban with vitamin K antagonists in patients with prevalent or incident atrial fibrillation as the indication for oral anticoagulation after successful TAVR. The primary efficacy outcome was a composite of adverse events consisting of death from any cause, myocardial infarction, ischemic stroke, systemic thromboembolism, valve thrombosis, or major bleeding. The primary safety outcome was major bleeding. On the basis of a hierarchical testing plan, the primary efficacy and safety outcomes were tested sequentially for noninferiority, with noninferiority of edoxaban established if the upper boundary of the 95% confidence interval for the hazard ratio did not exceed 1.38. Superiority testing of edoxaban for efficacy would follow if noninferiority and superiority were established for major bleeding. RESULTS A total of 1426 patients were enrolled (713 in each group). The mean age of the patients was 82.1 years, and 47.5% of the patients were women. Almost all the patients had atrial fibrillation before TAVR. The rate of the composite primary efficacy outcome was 17.3 per 100 person-years in the edoxaban group and 16.5 per 100 person-years in the vitamin K antagonist group (hazard ratio, 1.05; 95% confidence interval [CI], 0.85 to 1.31; P���=���0.01 for noninferiority). Rates of major bleeding were 9.7 per 100 person-years and 7.0 per 100 person-years, respectively (hazard ratio, 1.40; 95% CI, 1.03 to 1.91; P���=���0.93 for noninferiority); the difference between groups was mainly due to more gastrointestinal bleeding with edoxaban. Rates of death from any cause or stroke were 10.0 per 100 person-years in the edoxaban group and 11.7 per 100 person-years in the vitamin K antagonist group (hazard ratio, 0.85; 95% CI, 0.66 to 1.11). CONCLUSIONS In patients with mainly prevalent atrial fibrillation who underwent successful TAVR, edoxaban was noninferior to vitamin K antagonists as determined by a hazard ratio margin of 38% for a composite primary outcome of adverse clinical events. The incidence of major bleeding was higher with edoxaban than with vitamin K antagonists. (Funded by Daiichi Sankyo; ENVISAGE-TAVI AF ClinicalTrials.gov number, NCT02943785.).

Different hydrophilic and hydrophobic polymers are used as lubricious coatings to reduce vascular traumas in minimally invasive percutaneous procedures. Although they are usually very safe, there is still a risk of serious complications in patients undergoing such procedures, mostly derived from the devices' coating detachment and systemic embolization. The lungs are the most common organ involved, followed by the central nervous system. Yet, cutaneous embolization is unusual, and only 19 cases are available in the literature. Most commonly, they present as asymptomatic retiform purpura on the lower legs, which tends to involve spontaneously. Correct clinical diagnosis is not suspected in most cases, being cholesterol emboly or vasculitis the preferred options. Time interval since surgical procedure and appearance of lesions vary widely but they generally start in the first few days. Histopathological identification of the embolus as bluish, amorphous intraluminal material in dermal vessels is diagnostic, but vasculitic signs are not present. We report 2 cases of skin lesions as the main manifestation of polymer embolization after endovascular surgical procedures. In both cases, biopsy allowed identification of embolized foreign material and lesions resolved without specific treatment.

RESUMEN Introducción y objetivos: La Organización Mundial de la Salud calificó la enfermedad por coronavirus de 2019 (COVID-19) como una pandemia global. No está claro si el tratamiento previo con inhibidores de la enzima de conversión de la angiotensina (IECA) y antagonistas de los receptores de la angiotensina II (ARA-II) tiene un impacto en el pronóstico de los pacientes infectados con COVID-19. El objetivo es evaluar la implicación clínica del tratamiento previo con IECA/ARA-II en el pronóstico de la COVID-19. Métodos: Estudio observacional, retrospectivo, unicéntrico y de cohortes basado en todos los habitantes del área de salud. El análisis de los resultados principales (mortalidad, insuficiencia cardiaca, hospitalización, ingreso en la unidad de cuidados intensivos [UCI] y eventos cardiovasculares agudos mayores [un compuesto de mortalidad e insuficiencia cardiaca]), se ajustó mediante modelos de regresión logística multivariada y modelos de coincidencia de puntuación de propensión. Resultados: De una población total de 447.979 habitantes, se diagnosticó de infección por COVID-19 a 965 pacientes (0,22%), de los que 210 (21,8%) estaban en tratamiento con IECA o ARA-II en el momento del diagnóstico. El tratamiento con IECA/ARA-II (combinado o individual) no tuvo efecto en la mortalidad (OR = 0,62; IC95%, 0,17-2,26; p = 0,486), la insuficiencia cardiaca (OR = 1,37; IC95%, 0,39-4,77; p = 0,622), la tasa de hospitalizaciones (OR = 0,85; IC95%, 0,45-1,64; p = 0,638), los ingresos en UCI (OR = 0,87; IC95%, 0,30-2,50; p = 0,798) y los eventos cardiovasculares agudos mayores (OR = 1,06; IC95%, 0,39-2,83; p = 0,915). En el análisis del subgrupos de pacientes que requirieron hospitalización, el efecto se mantuvo neutral. Conclusiones: El tratamiento previo con IECA/ARA-II en pacientes con COVID-19 no tuvo efecto en la mortalidad, la aparición de insuficiencia cardiaca o la necesidad de hospitalización o ingreso en UCI. La supresión de los IECA/ARA-II en pacientes con COVID-19 no estaría justificada en ningún caso según las recomendaciones actuales de las sociedades científicas y las agencias gubernamentales.

Objectives This study sought to evaluate the incidence and causes of percutaneous coronary intervention (PCI) at different time periods following transcatheter aortic valve replacement (TAVR). Background Coronary artery disease (CAD) and aortic stenosis frequently coexist, but the optimal management of CAD following TAVR remains incompletely elucidated. Methods Patients undergoing unplanned PCI after TAVR were retrospectively included in an international multicenter registry. Results Between July 2008 and March 2019, a total of 133 patients (0.9%; from a total cohort of 15,325) underwent unplanned PCI after TAVR (36.1% after balloon-expandable bioprosthesis, 63.9% after self-expandable bioprosthesis). The median time to PCI was 191 days (interquartile range: 59 to 480 days). The daily incidence of PCI was highest during the first week after TAVR and then declined over time. Overall, the majority of patients underwent PCI due to an acute coronary syndrome, and specifically 32.3% had non–ST-segment elevation myocardial infarction, 15.4% had unstable angina, 9.8% had ST-segment elevation myocardial infarction, and 2.2% had cardiac arrest. However, chronic coronary syndromes are the main indication beyond 2 years. PCI success was reported in almost all cases (96.6%), with no significant differences between patients treated with balloon-expandable and self-expandable bioprostheses (100% vs. 94.9%; p = 0.150). Conclusions Unplanned PCI after TAVR is rare, with an incidence declining over time after TAVR. The main indication to PCI is acute coronary syndrome in the first 2 years after TAVR, and thereafter chronic coronary syndromes become prevalent. Unplanned PCIs are frequently successfully performed after TAVR, with no apparent differences between balloon-expandable and self-expandable bioprostheses. (Revascularization After Transcatheter Aortic Valve Implantation [REVIVAL]; NCT03283501 )

Morbidly obese (MO) patients are increasingly undergoing transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR) for severe aortic stenosis (AS). However, the best therapeutic strategy for these patients remains a matter for debate.Our aim was to compare the periprocedural and mid-term outcomes in MO patients undergoing TAVR versus SAVR.A multicentre retrospective study including consecutive MO patients (body mass index ≥40 kg/mAfter matching, periprocedural complications, including blood transfusion (14.1% versus 48.1%; p0.001), stage 2-3 acute kidney injury (3.99% versus 10.1%; p=0.002), hospital-acquired pneumonia (1.7% versus 5.8%; p=0.005) and access site infection (1.5% versus 5.5%; p=0.013), were more common in the SAVR group, as was moderate to severe patient-prosthesis mismatch (PPM; 9.9% versus 39.4%; p0.001). TAVR patients more frequently required permanent pacemaker implantation (14.4% versus 5.6%; p0.001) and had higher rates of ≥moderate residual aortic regurgitation (3.3% versus 0%; p=0.001). SAVR was an independent predictor of moderate to severe PPM (hazard ratio [HR] 1.80, 95% confidence interval [CI]: 1.25-2.59; p=0.002), while TAVR was not. In-hospital mortality was not different between groups (3.9% for TAVR versus 6.1% for SAVR; p=0.171). Two-year outcomes (including all-cause and cardiovascular mortality, and readmissions) were similar in both groups (log-rank p0.05 for all comparisons). Predictors of all-cause 2-year mortality differed between the groups; moderate to severe PPM was a predictor following SAVR (HR 1.78, 95% CI: 1.10-2.88; p=0.018) but not following TAVR (p=0.737).SAVR and TAVR offer similar mid-term outcomes in MO patients with severe AS, however, TAVR offers some advantages in terms of periprocedural morbidity.

Resumen Introduccion y objetivos El objetivo es analizar la incidencia, los predictores y el impacto pronostico de la insuficiencia cardiaca (IC) aguda tras el implante percutaneo de una valvula aortica (TAVI) con una protesis autoexpandible. Metodos Desde 2008, se incluye prospectivamente en nuestro registro de TAVI a todos los pacientes sometidos a TAVI en nuestro centro. Se analizan los factores pronosticos determinantes de IC aguda, y la relacion con la mortalidad mediante modelos de regresion de Cox. Resultados Se sometieron a TAVI 399 pacientes, con una media de edad de 82,4 ± 5,8 anos, de los que 213 (53,4%) eran mujeres. Durante el seguimiento (27,0 ± 24,1 meses), el 29,8% de los pacientes (n = 119) ingresaron en el hospital con el diagnostico de IC aguda, lo que representa una incidencia anual del 13,2% (IC95%, 11,1-15,8%). Al final del seguimiento, habian fallecido 150 pacientes (37,59%). En el grupo de IC aguda se evidencio una tasa de mortalidad significativamente mayor (el 52,1 frente al 31,4%; HR = 1,84; IC95%, 1,14-2,97; p Conclusiones El TAVI se asocia con una alta incidencia de eventos de IC aguda, lo que supone un gran impacto en la mortalidad. La IC aguda previa al implante y la puntuacion de la Society of Thoracic Surgeons fueron los unicos predictores de IC aguda hallados. Un indice de riesgo nutricional bajo y la enfermedad pulmonar obstructiva cronica son potentes determinantes de mortalidad en el grupo de IC aguda.

espanolIntroduccion y objetivos: Las lesiones coronarias calcificadas pueden impedir una correcta expansion del stent que en ocasiones conduce a eventos adversos. La litotricia intracoronaria es una nueva herramienta de modificacion 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 rapidamente, hasta el momento solo se han comunicado casos aislados en escenarios concretos. Se presentan los resultados en pacientes clinicamente complejos de la vida real con calcificacion coronaria grave. Metodos: Entre octubre de 2018 y marzo de 2019 se trato a 25 pacientes (37 lesiones) en 2 centros espanoles, lo que representa el 2,7% de los pacientes tratados con intervencion coronaria percutanea. Resultados: Las tasas de exito clinico y del dispositivo fueron del 84 y el 95%, y no se observaron complicaciones relacionadas con el procedimiento. En todos los casos se consiguio cruzar la lesion con el balon de litotricia intracoronaria, si bien en el 8% de los casos se rompio el balon durante el inflado. Se trataron con exito lesiones complejas, como oclusiones coronarias totales y estenosis del tronco comun. En comparacion con el estudio Disrupt CAD II, nuestros pacientes eran mas jovenes, pero tenian peor escenario clinico, con mayor prevalencia de diabetes (68%) e insuficiencia renal (22%), y hasta el 76% se presento como sindrome coronario agudo. En 3 de 4 pacientes con infraexpansion de stent tratados con litotricia intracoronaria no se consiguio una expansion adecuada tras el procedimiento. No hubo complicaciones ni mortalidad hospitalaria. Un paciente fallecio por causa no cardiaca a los 30 dias 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. EnglishIntroduction 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.

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.

Renal dysfunction in patients with ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (pPCI) indicates a poor long-term prognosis. However, the prognostic value of the improvement or stabilisation of renal function during follow-up has not yet been assessed. This study aimed to investigate the long-term predictive impact of the improvement or stabilisation of renal function after one year of follow-up in patients with STEMI undergoing pPCI with renal dysfunction at discharge.This prospective, single-centre cohort study included 2170 consecutive patients with STEMI who underwent pPCI. The glomerular filtration rate (GFR) was determined at hospital discharge and one-year follow-up. The median clinical follow-up was 72 months.Among the 2004 patients, 393 (19.6%) had a GFR60 ml/min, and 1611 (80.4%) had a GFR ≥ 60 ml/min at discharge. Among patients with GFR60 ml/min, data at one-year follow-up were available for 342. Of these patients, 127 (32%) showed improvement in renal function (defined as improvement in the Kidney Disease Improving Global Outcomes (KDIGO) chronic kidney disease (CKD) classification), 47 (12%) showed worsening of renal function (defined as worsening of the KDIGO CKD classification), and 168 (43%) showed no category changes. Improvement or stabilisation of GFR at one year of follow-up was associated with a reduction of major adverse cardiovascular events (MACE) [HR 0.51, 95% CI: 0.35-0.75, p = 0.001] and all-cause mortality [HR 0.54, 95% CI: 0.34-0.84, p = 0.007] during follow-up.The improvement or stabilisation of renal function at one-year follow-up in patients with STEMI and renal dysfunction is associated with a better long-term prognosis.

Presentación del caso Se presenta el caso de un varón de 83 años, hipertenso, diabético, con estenosis aórtica grave sintomática, función ventricular conservada e insuficiencia mitral ligera y sin enfermedad coronaria. Presentaba un riesgo quirúrgico bajo-intermedio (puntuación de la Society of Thoracic Surgeons del 3,1%) y en sesión médico-quirúrgica se decidió realizar el reemplazo quirúrgico de la válvula aórtica. Se implantó una bioprótesis aórtica sin suturas Perceval (Perceval Sutureless Aortic Heart Valve, Sorin) de tamaño L. El ecocardiograma de seguimiento previo al alta mostró un gradiente transvalvular aórtico de 22/11 mmHg y 2 chorros de regurgitación periprotésicos que sugerían insuficiencia aórtica de ligera a moderada, con una presión sistólica de la arteria pulmonar de 40 mmHg. Cinco meses después del reemplazo valvular, el paciente ingresó por insuficiencia cardiaca aguda con edema agudo de pulmón. En la exploración física, la auscultación mostró un soplo sugestivo de regurgitación aórtica de grado III/IV y estertores pulmonares bilaterales. El ecocardiograma reveló insuficiencia aórtica grave secundaria a la ausencia de cobertura del stent de la bioprótesis aórtica a nivel del anillo aórtico en la zona correspondiente al seno no coronariano y la mayor parte del seno coronariano derecho, que condicionaba 2 chorros de regurgitación hacia el ventrículo izquierdo, el cual...

Background Aortic stenosis (AS) is currently the most frequent heart valve disease. Symptomatic severe AS has a poor prognosis and transcatheter aortic valve implantation (TAVI) is becoming the therapy of choice in these patients. Changes in the conduction tissue after the procedure constitute one of the main limitations of TAVI, with a frequent need for a definitive pacemaker. Interatrial block (IAB) is defined as a prolonged P-wave duration and is related with atrial fibrosis. The presence of IAB could be a marker of conduction tissue abnormalities at other levels. No study has specifically analyzed the role of IAB as a predictor of the need for permanent pacemaker in patients with AS undergoing TAVI. Methods The Baseline Interatrial block and Transcatheter aortic valve implantation (BIT) registry will be performed in approximately 3000 patients with severe AS treated with TAVI. A centralized analysis of baseline ECGs will study the presence and type of IAB and other ECG data (rhythm, P-wave duration, PR and QRS intervals/intraventricular conduction disorders). Clinical follow-up will be carried out by local researchers. The primary endpoint will be the requirement of permanent pacemaker during post-TAVI hospitalization. As secondary objectives, the incidence of new onset AF, stroke, or mortality during follow-up will be analyzed. Secondary endpoints will include the incidence of new onset AF, stroke, or mortality during follow-up. Conclusion The BIT registry will study, for the first time, the influence of previous IAB in the need of permanent pacemaker after TAVI: This large registry will also provide information regarding the association of this and other ECG parameters with prognosis. Sin financiación 0.944 JCR (2019) Q4, 133/138 Cardiac & Cardiovascular Systems 0.448 SJR (2019) Q3, 205/362 Cardiology and Cardiovascular Medicine No data IDR 2019 UEM

Coronary artery disease (CAD) is a common co-morbidity in transcatheter aortic valve implantation (TAVI) patients, but the prognostic value of coronary revascularization before TAVI is currently unknown. The aim of the present study was to assess the impact of coronary revascularization in patients who underwent TAVI. Patients underwent TAVI from 2008 to 2016 were included in the study. Baseline SYNTAX score and residual SYNTAX score (rSS) after percutaneous coronary intervention were calculated. Based on rSS, patients were classified as complete revascularization (rSS = 0), reasonably incomplete revascularization (rSS0 and8), and incomplete revascularization (rSS ≥8). The primary objective was to evaluate the impact of CAD and rSS on major cardiovascular adverse events (MACEs). The secondary objective was to assess the impact of rSS on hospitalization for heart failure. A total of 349 patients (mean age 82.4 ± 5.7 years, 53% women) were included in the study. A total of 187 patients (53.6%) had CAD (mean baseline SYNTAX score 9.2 ± 8.1). Percutaneous coronary intervention was performed in 29.9% of patients, achieving reasonably incomplete revascularization in 45.4%, and incomplete revascularization in 24.5%. The mean follow-up was 35.2 ± 25.3 months. No differences were observed in MACE rate between the CAD and non-CAD groups, or between the different degrees of revascularization. Differences were also not seen in the different levels of revascularization and hospitalization due to heart failure. In patients who underwent TAVI in this study, no association was found between the presence of CAD or the degree of revascularization in a long-term follow-up.

Introduction and objectives: Evidence of the long-term prognostic benefit of new generation drug-eluting stents (DES) is limited, especially in the context of primary percutaneous coronary interventions. The goal of this study was to compare the long-term prognostic impact of the implantation of DESs versus bare-metal stents (BMSs) in real-world patients undergoing primary percutaneous coronary interventions. Methods: A cohort study was conducted with 1499 consecutive patients diagnosed with ST-segment elevation myocardial infarction who underwent percutaneous coronary interventions between January 2008 and December 2015. A total of 24.9% of the patients received a DES. A matched propensity score analysis yielded 2 groups of 262 matched patients depending on whether they were treated with a DES or a BMS. Results: During follow-up (median 1015 days), the patients who received DES had a lower all-cause mortality rate (6.5% vs 12.2%; P = .049) a lower composite endpoint of major adverse cardiac events (16.4% vs 25.2%; P = .049) and a lower patient-oriented composite endpoint of death from any cause, myocardial infarction and revascularization at follow-up (12.6% vs 22.5%; P = .017). No differences were seen in the definite stent thrombosis rate. Conclusions: In our registry, in a real-world population of consecutive patients undergoing primary percutaneous coronary interventions, the use of DES versus BMS associated more survival and less clinically significant major adverse cardiac events and patient-oriented composite endpoints in a long-term follow-up, without any differences in stent thrombosis.

espanolIntroduccion y objetivos: La evidencia del beneficio en el pronostico a largo plazo de los stents farmacoactivos (SFA) de nueva generacion es limitada, en especial en los pacientes con angioplastia primaria. El objetivo de este trabajo fue comparar el impacto en el pronostico a largo plazo de la implantacion de SFA frente a stents metalicos (SM) en pacientes del mundo real tratados con angioplastia primaria. Metodos: Estudio de cohortes en el que incluyeron 1.499 pacientes ingresados de forma consecutiva con diagnostico de infarto agudo de miocardio con elevacion del segmento ST y sometidos a angioplastia primaria entre enero de 2008 y diciembre de 2015. El 24,9% recibio un SFA. Mediante un analisis de emparejamiento por puntuacion de propension se obtuvieron 2 grupos de 262 pacientes emparejados segun la implantacion de SFA o SM. Resultados: Durante el seguimiento (mediana de 1.015 dias), los pacientes que recibieron SFA tuvieron tasas mas bajas de mortalidad por todas las causas (6,5 frente a 12,2%; p = 0,049), asi como en el objetivo combinado de eventos adversos mayores (16,4 frente a 25,2%; p = 0,049) y un objetivo combinado orientado al paciente que incluia muerte por cualquier causa, infarto de miocardio y revascularizacion en el seguimiento (12,6 frente a 22,5%; p = 0,017). No se observaron diferencias en cuanto a trombosis definitiva del stent. Conclusiones: En nuestro registro, en una poblacion del mundo real de pacientes consecutivos tratados con ICP primaria, la utilizacion de SFA frente a SM se asocio a una mayor supervivencia y una reduccion de los eventos clinicos en el seguimiento a largo plazo, sin observar diferencias en la trombosis del stent. EnglishIntroduction and objectives: Evidence of the long-term prognostic benefit of new generation drug-eluting stents (DES) is limited, especially in the context of primary percutaneous coronary interventions. The goal of this study was to compare the long-term prognostic impact of the implantation of DESs versus bare-metal stents (BMSs) in real-world patients undergoing primary percutaneous coronary interventions. Methods: A cohort study was conducted with 1499 consecutive patients diagnosed with ST-segment elevation myocardial infarction who underwent percutaneous coronary interventions between January 2008 and December 2015. A total of 24.9% of the patients received a DES. A matched propensity score analysis yielded 2 groups of 262 matched patients depending on whether they were treated with a DES or a BMS. Results: During follow-up (median 1015 days), the patients who received DES had a lower all-cause mortality rate (6.5% vs 12.2%; P = .049) a lower composite endpoint of major adverse cardiac events (16.4% vs 25.2%; P = .049) and a lower patient-oriented composite endpoint of death from any cause, myocardial infarction and revascularization at follow-up (12.6% vs 22.5%; P = .017). No differences were seen in the definite stent thrombosis rate. Conclusions: In our registry, in a real-world population of consecutive patients undergoing primary percutaneous coronary interventions, the use of DES versus BMS associated more survival and less clinically significant major adverse cardiac events and patient-oriented composite endpoints in a long-term follow-up, without any differences in stent thrombosis.

Background: Limited data are available regarding change in the nutritional status after transcatheter aortic valve replacement (TAVR). This study evaluated the prognostic impact of the change in the geriatric nutritional risk index following TAVR. Methods: TAVR patients were analyzed in a prospective and observational study. To analyze the change in nutritional status, geriatric nutritional risk index of the patients was calculated on the day of TAVR and at 3-month follow-up. The impact of the change in nutritional risk index after TAVR on all-cause mortality, heart failure hospitalization (HF-h), and the composite of all-cause death and HF hospitalization was analyzed using the Cox Proportional Hazards model. Results: Four hundred thirty-three patients were included. After TAVR, 68.4% (n=182) patients with baseline nutritional risk improved compared with 31.6% (n=84) who remained at nutritional risk. The change from no-nutritional risk to nutritional risk after TAVR occurred in 15.0% (n=25), while 85.0% (n=142) remained without risk of malnutrition. During follow-up, 157 (36.3%) patients died and 172 patients (39.7%) were hospitalized due to HF. Patients who continued to be at nutritional risk had a higher risk of mortality (hazard ratio [HR], 2.10 [95% CI, 1.30–3.39], P =0.002), HF-h (HR, 1.97 [95% CI, 1.26–3.06], P =0.000), and the composite of death and HF-h (HR, 2.0 [95% CI, 1.37–2.91], P P =0.003), HF-h (HR, 0.50 [95% CI, 0.34–0.74], P =0.001), and the composite outcome (HR, 0.44 [95% CI, 0.32–0.62], P Conclusions: Remaining at nutritional risk after TAVR confers a poor prognosis and is associated with an increased risk of mortality and HF-h, while the change from risk of malnutrition to non-nutritional risk after TAVR was associated with a halving of the risk of mortality and HF-h. Further studies are needed to identify whether patients at nutritional risk would benefit from nutritional intervention during processes of care of TAVR programs.

Hypertension is a prevalent condition among SARS-CoV-2 infected patients. Whether renin-angiotensin-aldosterone system (RAAS) inhibitors are beneficial or harmful is controversial.We have performed a national retrospective, nonexperimental comparative study from two tertiary hospitals to evaluate the impact of chronic use of RAAS inhibitors in hypertensive COVID-19 patients. A meta-analysis was performed to strengthen our findings.Of 849 patients, 422 (49.7%) patients were hypertensive and 310 (73.5%) were taking RAAS inhibitors at baseline. Hypertensive patients were older, had more comorbidities, and a greater incidence of respiratory failure (-0.151 [95% CI -0.218, -0.084]). Overall mortality in hypertensive patients was 28.4%, but smaller among those with prescribed RAAS inhibitors before (-0.167 [95% CI -0.220, -0.114]) and during hospitalization (0.090 [-0.008,0.188]). Similar findings were observed after two propensity score matches that evaluated the benefit of angiotensin-converting enzyme inhibitors and angiotensin receptor blockers among hypertensive patients. Multivariate logistic regression analysis of hypertensive patients found that age, diabetes mellitus, C-reactive protein, and renal failure were independently associated with all-cause mortality. On the contrary, ACEIs decreased the risk of death (OR 0.444 [95% CI 0.224-0.881]). Meta-analysis suggested a protective benefit of RAAS inhibitors (OR 0.6 [95% CI 0.42-0.8]) among hypertensive COVID-19.Our data suggest that RAAS inhibitors may play a protective role in hypertensive COVID-19 patients. This finding was supported by a meta-analysis of the current evidence. Maintaining these medications during hospital stay may not negatively affect COVID-19 outcomes.La hipertensión es una condición prevalente entre los pacientes infectados por el SARS-CoV-2. Es controvertido si los inhibidores del sistema renina-angiotensina-aldosterona (SRAA) son beneficiosos o perjudiciales.Hemos desarrollado un estudio comparativo nacional retrospectivo y no experimental en 2 hospitales terciarios para evaluar el impacto del uso crónico de inhibidores del SRAA en pacientes hipertensos con COVID-19. Se realizó un metaanálisis para reforzar los hallazgos.De 849 pacientes, 422 (49,7%) eran hipertensos y 310 (73,5%) tomaban inhibidores del SRAA al inicio del estudio. Los pacientes hipertensos eran mayores, tenían más comorbilidades y una mayor incidencia de insuficiencia respiratoria (−0,151; IC 95%: [−0,218; −0,084]). La mortalidad global en los pacientes hipertensos fue del 28,4%, pero fue menor entre los que tenían prescritos inhibidores del SRAA antes (−0,167; IC 95%: [−0,220; −0,114]) y durante la hospitalización (0,090; [−0,008; 0,188]). Se observaron hallazgos similares tras 2 emparejamientos de puntuación de propensión que evaluaron el beneficio de los inhibidores de la enzima convertidora de angiotensina y los bloqueadores de los receptores de angiotensina entre los pacientes hipertensos. El análisis de regresión logística multivariante de los pacientes hipertensos reveló que la edad, la diabetes mellitus, la proteína C reactiva y la insuficiencia renal se asociaban de forma independiente con la mortalidad por todas las causas. Por el contrario, los inhibidores de la enzima convertidora de angiotensina disminuyeron el riesgo de muerte (OR 0,444; IC 95%: 0,224-0,881). El metaanálisis indicó un beneficio protector de los inhibidores del SRAA (OR 0,6; IC 95%: 0,42-0,8) entre los hipertensos con COVID-19.Nuestros datos indican que los inhibidores del SRAA pueden desempeñar un papel protector en los pacientes hipertensos con COVID-19. Este hallazgo fue apoyado por un metaanálisis de la evidencia actual. Su mantenimiento durante la estancia hospitalaria puede no afectar negativamente a los resultados de la COVID-19.

BACKGROUND: Cardiovascular risk factors and usage of cardiovascular medication are prevalent among coronavirus disease 2019 (COVID-19) patients. Little is known about the cardiovascular implications of COVID-19. The goal herein, was to evaluate the prognostic impact of having heart disease (HD) and taking cardiovascular medications in a population diagnosed of COVID-19 who required hospitalization. Also, we studied the development of cardiovascular events during hospitalization. METHODS: Consecutive patients with definitive diagnosis of COVID-19 made by a positive real time- -polymerase chain reaction of nasopharyngeal swabs who were admitted to the hospital from March 15 to April 14 were included in a retrospective registry. The association of HD with mortality and with mortality or respiratory failure were the primary and secondary objectives, respectively. RESULTS: A total of 859 patients were included in the present analysis. Cardiovascular risk factors were related to death, particularly diabetes mellitus (hazard ratio in the multivariate analysis: 1.810 [1.159- -2.827], p = 0.009). A total of 113 (13.1%) patients had HD. The presence of HD identified a group of patients with higher mortality (35.4% vs. 18.2%, p < 0.001) but HD was not independently related to prognosis; renin-angiotensin-aldosterone system inhibitors, calcium channel blockers, diuretics and beta-blockers did not worsen prognosis. Statins were independently associated with decreased mortality (0.551 [0.329-0.921], p = 0.023). Cardiovascular events during hospitalization identified a group of patients with poor outcome (mortality 31.8% vs. 19.3% without cardiovascular events, p = 0.007). CONCLUSIONS: The presence of HD is related to higher mortality. Cardiovascular medications taken before admission are not harmful, statins being protective. The development of cardiovascular events during the course of the disease is related to poor outcome.

Purpose: Deterioration is sometimes unexpected in SARS-CoV2 infection. The aim of our study is to establish laboratory predictors of mortality in COVID-19 disease which can help to identify high risk patients.Methods: All patients admitted to hospital due to Covid-19 disease were included. Laboratory biomarkers that contributed with significant predictive value for predicting mortality to the clinical model were included. Cut-off points were established, and finally a risk score was built. Results: 893 patients were included. Median age was 68.2 years(CI 95% 53.0-83.4). 87(9.7%) were admitted to Intensive Care Unit(ICU) and 72(8.1%) also needed mechanical ventilation support. 171(19.1%) patients died. A Covid-19 Lab score ranging from 0 to 30 points was calculated on the basis of a multivariate logistic regression model in order to predict mortality with a weighted score that included haemoglobin, erythrocytes, leukocytes, neutrophils, lymphocytes, creatinine, C-reactive protein, interleukin-6, procalcitonin, lactate dehydrogenase (LDH), and D-dimer. Three groups were established. Low mortality risk group under 12 points, 12 to 18 were included as moderate risk, and high risk group were those with 19 or more points. Low risk group as reference, moderate and high patients showed mortality OR 4.75(CI95% 2.60-8.68) and 23.86(CI 95% 13.61-41.84), respectively. C-statistic was 0-85(0.82-0.88) and Hosmer-Lemeshow p-value 0.63.Conclusion: Covid-19 Lab score can very easily predict mortality in patients at any moment during admission secondary to SARS-CoV2 infection. It is a simple and dynamic score, and it can be very easily replicated. It could help physicians to identify high risk patients to foresee clinical deterioration.

Background The coronavirus disease 2019 (COVID-19) is caused by SARS-CoV2 that interfaces with the renin-angiotensin-aldosterone system (RAAS) through angiotensin-converting enzyme 2 (ACE-2). This interaction has been proposed as a potential risk factor in patients treated with RAAS-inhibitors. Objectives To analyze if RAAS-inhibitors modify the risk for COVID-19. Methods RASTAVI (NCT03201185) is an ongoing randomized clinical trial randomly allocating Ramipril or control after successful transcatheter aortic valve replacement at 14 centers is Spain. We performed a non-pre-specified interim analysis to evaluate its impact on COVID-19 risk in this vulnerable population. Results As in April 1st 2020, 102 patients (50 Ramipril and 52 controls) were included in the trial. Mean age was 82.3±6.1 years, 56.9% males. Median time of Ramipril treatment was 6 months [IQR:2.9-11.4]. Eleven patients (10.8%) have been diagnosed with COVID-19 (6 in control group and 5 receiving Ramipril, HR=1.150 [95%CI: 0.351-3.768]). The risk of COVID-19 was increased in older patients (p=0.019), those with atrial fibrillation (p=0.066), lower hematocrit (p=0.084), and more comorbidities according to Society of thoracic surgeons score (p=0.065). Admission and oxygen supply was required in 4.9% (2 patients in the Ramipril and 3 in control), and 4 of them died (two in each randomized group). A higher body mass index was the only factor increasing the mortality rate (p=0.039). Conclusions In a high risk population of old patients with cardiovascular disease, randomization to Ramipril had no impact in the incidence or severity of COVID-19. This analysis supports the maintenance of RAAS-inhibitor treatment during COVID-19 crisis., The use of RAAS-inhibitors in patients suffering COVID-19 or at risk is controversial. A total of 102 patients with cardiovascular disease were randomized in the RASTAVI trial to Ramipril (n=50) or control (n=52). Of them, 11 patients (10.8%) developed COVID-19 up to April/2020 (five from Ramipril group and six from control group), and four died (two from each group). COVID-19 occurred more often in older patients and higher body-mass index was related to greater mortality. However, the use of Ramipril did not affect the risk of infection or the prognosis. Hence, the use of RAAS-inhibitors during COVID-19 pandemic seems safe.

The residual SYNTAX score (rSS) was designed and validated to quantify the burden of residual coronary artery disease after percutaneous coronary intervention (PCI). The aim of this study was to assess the prognostic impact of rSS in patients with ST-segment elevation myocardial infarction (STEMI) and multivessel disease undergoing primary-PCI.This retrospective cohort study included 1499 consecutive patients with STEMI who underwent primary-PCI between January 2008 and December 2015. After exclusion criteria, the multivessel disease cohort (n=535) was divided into three groups, according to rSS: complete revascularization (rSS=0; n=198), reasonable incomplete revascularization (0rSS8; n=238) and incomplete revascularization (rSS≥8; n=99).In-hospital mortality was significantly lower in patients with complete and reasonable incomplete revascularization, when compared to those with incomplete revascularization (1.5% vs. 1.7% vs. 9.0%, p0.001). During follow-up (median 2.4years), rSS was positively correlated with MACE (25.3% for rSS=0 vs. 31.1% for 0rSS8 vs. 47.0% for rSS≥8, p=0.001) and all-cause mortality (5.1% vs. 10.5% vs. 19.2%, p=0.001). The rSS was also an independent predictor of MACE (when compared with complete revascularization, odds ratio [OR] was 1.5 for reasonable incomplete and 1.8 for incomplete revascularization) and all-cause mortality during follow-up (OR 2.9 for reasonable incomplete and 3.9 for incomplete revascularization), adding prognostic value over control variables and GRACE.In a real-world cohort of patients with STEMI and multivessel disease who underwent PCI, the rSS added important prognostic information over control variables and GRACE, being an independent predictor of MACE and all-cause mortality during follow-up.

Introduction and objectives The optimal treatment of patients with multivessel coronary artery disease and ST-segment elevation acute myocardial infarction (STEMI) who undergo primary percutaneous coronary intervention (PCI) is controversial. The aim of this study was to access the prognostic impact of multivessel PCI vs culprit vessel-only PCI in real-world patients with STEMI and multivessel disease. Methods This was a retrospective cohort study of 1499 patients with STEMI diagnosis who underwent primary PCI between January 2008 and December 2015. About 40.8% (n = 611) patients had multivessel disease. We performed a propensity score matched analysis to obtain 2 groups of 215 patients paired according to whether or not they had undergone multivessel PCI or culprit vessel-only PCI. Results During follow-up (median, 2.36 years), after propensity score matching, patients who underwent multivessel PCI had lower rates of mortality (5.1% vs 11.6%; Peto-Peto P = .014), unplanned repeat revascularization (7.0% vs 12.6%; Peto-Peto P = .043) and major acute cardiovascular events (22.0% vs 30.8%; Peto-Peto P = .049). These patients also showed a trend to a lower incidence of myocardial infarction (4.2% vs 6.1%; Peto-Peto P = .360). Conclusions In real-world patients presenting with STEMI and multivessel coronary artery disease, a multivessel PCI strategy was associated with lower rates of mortality, unplanned repeat revascularization, and major acute cardiovascular events.