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Resumen Introduccion y objetivos El acceso transaxilar (ATx) se ha convertido en el acceso alternativo al transfemoral (ATF), mas utilizado en pacientes sometidos a implante percutaneo de valvula aortica (TAVI). El objetivo principal de este estudio es comparar la mortalidad total hospitalaria y a los 30 dias de los pacientes incluidos en el registro espanol de TAVI a los que se trato por acceso ATx frente a ATF. Metodos Se analizo a todos los pacientes incluidos en el registro espanol de TAVI tratados por ATx o ATF. Los eventos hospitalarios y a los 30 dias de seguimiento se definieron segun las recomendaciones de la Valve Academic Research Consortium. Se evaluo el impacto de la via de acceso mediante emparejamiento por puntuacion de propension segun las caracteristicas clinicas y ecograficas. Resultados Se incluyo a 6.603 pacientes, 191 (2,9%) tratados por ATx y 6.412 con ATF. Despues del ajuste (grupo de ATx, n = 113; grupo de ATF, n = 3.035), el exito del dispositivo fue similar entre ambos grupos (el 94% en el grupo de ATx frente al 95% en el de ATF; p = 0,95); sin embargo, se observo un incremento en la tasa de infarto agudo de miocardio (OR = 5,3; IC95%, 2,0-13,8; p = 0,001), complicaciones renales (OR = 2,3; IC95%, 1,3-4,1; p = 0,003) e implante de marcapasos (OR = 1,6; IC95%, 1,01-2,6; p = 0,03) en el grupo de ATx comparado con el de ATF. De mismo modo, la mortalidad hospitalaria y a los 30 dias fueron superiores en el grupo de ATx (respectivamente, OR = 2,2; IC95%, 1,04-4,6; p = 0,039; y OR = 2,3; IC95%, 1,2-4,5; p = 0,01). Conclusiones El ATx se asocia con un aumento en la mortalidad total tanto hospitalaria como a los 30 dias frente al ATF. Ante estos resultados, el ATx debe considerarse solo en caso de que el ATF no sea posible.

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).

Introduction and objectives: After the positive pre-clinical and clinical results with Angiolite, a cobalt-chromium sirolimus-eluting stent, we decided to analyze its performance in a non-selected, real-world population: the RANGO registry. Methods: We conducted an observational, prospective, multicenter registry of patients with different clinical indications. All consecutive patients treated with percutaneous coronary intervention with, at least, 1 Angiolite stent and who gave their informed consent were included. The registry primary endpoint was the occurrence of target lesion failure (TLF) at 6, 12, and 24 months defined as cardiovascular death, myocardial infarction (MI) related to target vessel, and clinically driven target lesion revascularization. The secondary endpoints were the individual components of the primary endpoint, major adverse cardiovascular events (MACE: all-cause mortality, any MI, or any revascularization), and stent thrombosis. We describe the 2-year clinical results of the RANGO study in the entire population, in those who only received Angiolite stents, and in 2 predefined subgroups: diabetics and patients with small-vessels (≤ 2.5mm). Results: 646 patients (426 of them only received Angiolite stents) with a high-risk profile were recruited: prevalence of previous MI (18.4%), previous coronary revascularization (23.4%), clinical presentation as ST-segment elevation MI (23.1%), and multivessel disease (47.8%). At the 2-year follow-up, the rates of TLF, MACE, and stent thrombosis were 3.4%, 9.6%, and 0.9%, respectively. Similar results were observed among patients treated with Angiolite stents only: TLF, 3.1%; MACE, 8.0%; thrombosis, 0.7%. The rates were not significantly different for the diabetic (TLF, 3.0%; MACE, 14.1%; thrombosis, 1.0%), and small-vessel subgroups (TLF, 4.3%; MACE, 12.1%; thrombosis, 0%). Conclusions: In conclusion, the results of this observational registry on the use of Angiolite in a real-world population, including a high-risk population, corroborate the excellent results observed in previous studies, up to a 2-year follow-up. An extended 5-year follow-up is planned to discard the occurrence of late events.

HOW WOULD I APPROACH IT? Currently, the management of thrombosis refractory to IV anticoagulant therapy of heart valves is limited: reintervention or fibrinolysis. Both procedures bring acceptable immediate results, but logically reintervention has a greater impact on the patient’s recovery. Also, the treatment of choice will be influenced by a series of parameters including hemorrhagic risk, the patient’s clinical status, the size of the thrombus, other concomitant findings in the imaging study, etc. The female patient of this case is young with a mechanical prosthesis in the mitral and aortic position and a second episode of mitral valve thrombosis with serious clinical repercussions. Also, it is a case refractory to pharmacological treatment after reintervention due a first thrombosis of acute presentation (< 3 months after the intervention). This makes us have to consider 2 important details before moving on with the possible percutaneous treatment: could this be a case of endocarditis with an added thrombus? and also, is this the case of a patient with some sort of refractoriness to antithrombotic treatment? I am exposing this because, in both cases, the percutaneous therapeutic strategy did not seem like the optimal strategy to me. Since thrombotic content was not massive here, the first...

Vàlvula aòrtica bicúspide; Talla del bicúspide; SAPIEN 3/Ultra Válvula aórtica bicúspide; Talla del bicúspide; SAPIEN 3/Ultra Bicuspid aortic valve; Bicuspid sizing; SAPIEN 3/Ultra Severe aortic stenosis patients with bicuspid anatomy have been excluded from the major transcatheter aortic valve replacement (TAVI) randomized clinical trials. As a result, there is no official recommendation on bicuspid TAVI. A panel of bicuspid experts was created to fill this gap. In this consensus statement, an algorithm is proposed to guide the choice of surgery or TAVI within this complex patient population, depending on aortic dilatation, age, surgical risk score, and anatomy. A step-by-step guide for sizing and positioning of the SAPIEN 3/Ultra TAVI bioprostheses is presented. Annular sizing remains the primary strategy in most bicuspid patients. However, some anatomies may require sizing at the supra-annular level, for which patients the panel recommends the circle method, a dedicated sizing and positioning approach for SAPIEN 3/Ultra. The consensus provides valuable pre-operative insights on the interactions between SAPIEN 3/Ultra and the bicuspid anatomy; understanding the valve–anatomy relationship is critical to avoid complications and to optimize outcomes for patients. The journal’s Rapid Service Fee was supported by Edwards Lifesciences.

Free wall perforation during percutaneous manipulation of devices and wires into the ventricular cavities is an uncommon but life-threatening complication that should be managed with emergent surgery whenever possible. However, the number of patients with prohibitive surgical risk that undergo complex percutaneous cardiac procedures is increasing. Some cases of ventricle perforation during Impella® (Abiomed; Danvers, MA) implantation have been previously reported but in all previous reported cases the patient underwent emergent surgery. We present a case of iatrogenic perforation during Impella® implantation that was emergently treated using an Amplatzer® Duct Occluder II device (Abbott Vascular; Santa Clara, CA).

Objectives To assess the efficacy and safety of excimer laser coronary atherectomy (ELCA), as well as, the long-term outcomes and the factors associated with ELCA failure in uncrossable lesions. Background Uncrossable lesions constitute a challenge for percutaneous coronary intervention. Methods This multicenter registry included 126 patients with 126 uncrossable lesions. Study endpoints were ELCA success, technical success and a composite of cardiac death, myocardial infarction (MI), and target-lesion revascularization (TLR) on follow-up. Predictors of ELCA failure were analyzed. Results Moderate or severe calcification was present in 79 (62.7%) of the lesions and 58 (46%) were a chronic total occlusion. ELCA success was obtained in 103 (81.8%) patients. Rotational atherectomy was attempted as bailout in 21 out of 23 ELCA failure (91.3%), being successful in 14 (66.7%) of them. Finally, technical and procedural success were achieved in 114 (90.5%) and 110 (87.3%) of the patients. Severe calcification was independently associated with ELCA failure (OR: 3.73, 95% CI: 1.35-10.32; p = .011). Two (1.6%) patients died (one after a stroke and another patient because of heart failure), 4 (3.2%) developed a non-Q MI without clinical consequences and 1 (0.8%) patient had a Q-MI. Other complications were ventricular tachycardia/fibrillation (n = 2; 1.6%) and flow-limiting dissection (n = 1, 0.8%). At follow-up (median 424 days), 3 (2.4%) patients died (1 (0.8%) from cardiovascular cause) and 15 (11.9%) required TLR. Conclusions In our multicenter experience, ELCA use demonstrated to be safe and reasonably effective with a rate of events on follow-up relatively low. Severe calcification was associated with ELCA failure.

Introduction and objectives: This study primary endpoint was to present the in-hospital all-cause mortality of the Spanish TAVI registry from its inception until 2018. Secondary endpoints included other in-hospital clinical events, 30-day all-cause mortality, and an assessment of the time trend of this registry. Methods: All consecutive patients included in the Spanish TAVI registry were analyzed. In this time-based analysis, the population was been divided into patients treated before 2014 (cohort A: 2009-2013) and patients treated between 2014 and 2018 (cohort B). Results: From August 2007 to June 2018, 7180 patients were included. The mean age was 81.2 ± 6.5 years and 53% were women. The logistic EuroSCORE was 12% (8-20). Transfemoral access was used in 89%. In-hospital and 30-day all-cause mortality was 4.7% and 5.7%, respectively. On the time-based analyses during the hospital stay, the rate of myocardial infarction, stroke, need for pacemakers, tamponade, coronary obstruction, and vascular complications was similar between both groups. However, cohort B showed less need for conversion to surgery and malapposition of the valve. Also, the implant success rate increased from 93% to 96% (P< .001). In-hospital and 30-day all-cause mortality was significantly lower in cohort B, ([OR, 0.65; IC95%, 0.48-0.86; P= .003] and [OR, 0.71; IC95%, 0.54-0.92; P= .002], respectively). Conclusions: The time trend analysis of the Spanish TAVI registry showed a change in the patients’ clinical profile and an improvement in the in-hospital clinical outcomes and 30-day all-cause mortality in patients treated more recently.

Introduction and objectives: The Lotus Valve device (Boston Scientific) is a second-generation fully-retrievable and repositionable transcatheter aortic valve. We report the initial multicenter experience with the Lotus valve in the management of patients with severe aortic stenosis. Methods: Observational study that described the short and long-term results of implanting the Lotus valve in 8 Spanish and Portuguese centers from March 2014 through April 2016. Results: The study included 102 patients (mean age 80.4 ± 6.1 years; STS score 5.2% ± 3.3%) with severe symptomatic aortic stenosis (mean aortic valve area 0.66 ± 0.17 cm2, aortic gradients 74.3 / 45.6 mmHg). The valve was successfully implanted in 100 patients (98%), with significant improvement in both the peak and mean aortic valve gradients and with only one patient showing moderate paravalvular regurgitation. Upon hospital discharge, mortality rate was 3.9% while the stroke rate was 2.9%. No cases of valve embolization, ectopic valve deployment or additional valve implantation (valve-in-valve) were seen. Thirty-three patients (32.3%) received a permanent pacemaker. Conclusions: The Lotus Valve System is effective and safe for the management of patients with severe symptomatic aortic stenosis. In particular, considering the low rate of periprosthetic regurgitation and lack of complications like embolization or ectopic valve deployment; however at the expense of a high pacemaker implantation rate.

Objectives This study sought to determine the incidence, clinical impact, and changes over time of mitral regurgitation (MR) in patients with low-flow, low-gradient aortic stenosis (LFLG-AS) undergoing transcatheter aortic valve replacement (TAVR). Background Few data exist on the clinical impact and changes in severity over time of MR in patients with LFLG-AS undergoing TAVR. Methods A total of 308 TAVR candidates with LFLG-AS were included. Patients were categorized according to MR severity at baseline, and presence of MR improvement at 12-month follow-up. Clinical outcomes were assessed at 1 and 12 months (+ echocardiography), and yearly thereafter. Results Baseline mild and moderate-to-severe MR were present in 118 (38.3%) and 115 (37.3%) patients, respectively. MR was of functional and mixed etiology in 77.2% and 22.7% of patients, respectively. A total of 131 patients (42.5%) died after a median follow-up of 2 (1 to 3) years. Baseline moderate-or-greater MR had no impact on mortality (hazard ratio [HR]: 1.34; 95% confidence interval [CI]: 0.72 to 2.48) or heart failure hospitalization (HR: 1.02; 95% CI: 0.49 to 2.10). At 1-year follow-up, MR improved in 44.3% of patients and remained unchanged/worsened in 55.7%. The lack of MR improvement was associated with a higher risk of all-cause and cardiac mortality (HR: 2.02; 95% CI: 1.29 to 3.17; HR: 3.03; 95% CI: 1.27 to 7.23, respectively), rehospitalization for cardiac causes (HR: 1.50; 95% CI: 1.04 to 2.15), and an increased overall-mortality/heart failure rehospitalization (HR: 1.94; 95% CI: 1.25 to 3.02). A higher baseline left ventricular end-diastolic diameter and a higher increase in left ventricular ejection fraction were found to be independent predictors of MR improvement at 1-year follow-up (odds ratio: 0.69; 95% CI: 0.51 to 0.94; and odds ratio: 0.81; 95% CI: 0.67 to 0.96, respectively). Conclusions Most TAVR candidates with LFLG-AS had some degree of MR, of functional origin in most cases. MR improved in about one-half of patients, with larger left ventricular size and a higher increase in left ventricular ejection fraction post-TAVR determining MR improvement over time. The lack of MR improvement at 1 year was associated with poorer outcomes.

OBJECTIVES: To characterize sex differences in the composition of coronary thrombus in patients with ST-segment elevation myocardial infarction (STEMI), especially in the young (age ≤ 55 years). BACKGROUND: Women have smaller coronary vessels than men and their vascular lesions can be influenced by different exposure to circulating estrogens throughout life. These factors could determine a different composition of the coronary thrombus in women with STEMI. METHODS: A prospective, multicenter study was conducted on patients with STEMI and coronary thrombus was aspirated immediately before percutaneous coronary intervention (PCI) using a suction catheter (ProntoV3® or Export®). Histopathology, immunohistochemistry and ELISA techniques were used for the quantitative determination of fibrin, p-selectin and von Willebrand factor (vWF) within thrombi. RESULTS: Thrombi were collected from 100 patients (50 men and 50 women; 13 women and 13 men of

Introduction and objectives: After the positive pre-clinical and clinical results with Angiolite, a cobalt-chromium sirolimus-eluting stent, we decided to analyze its performance in a non-selected, real-world population: the RANGO registry. Methods: We conducted an observational, prospective, multicenter registry of patients with different clinical indications. All consecutive patients treated with percutaneous coronary intervention with, at least, 1 Angiolite stent and who gave their informed consent were included. The registry primary endpoint was the occurrence of target lesion failure (TLF) at 6, 12, and 24 months defined as cardiovascular death, myocardial infarction (MI) related to target vessel, and clinically driven target lesion revascularization. The secondary endpoints were the individual components of the primary endpoint, major adverse cardiovascular events (MACE: all-cause mortality, any MI, or any revascularization), and stent thrombosis. We describe the 2-year clinical results of the RANGO study in the entire population, in those who only received Angiolite stents, and in 2 predefined subgroups: diabetics and patients with small-vessels ("64; 2.5mm). Results: 646 patients (426 of them only received Angiolite stents) with a high-risk profile were recruited: prevalence of previous MI (18.4%), previous coronary revascularization (23.4%), clinical presentation as ST-segment elevation MI (23.1%), and multivessel disease (47.8%). At the 2-year follow-up, the rates of TLF, MACE, and stent thrombosis were 3.4%, 9.6%, and 0.9%, respectively. Similar results were observed among patients treated with Angiolite stents only: TLF, 3.1%; MACE, 8.0%; thrombosis, 0.7%. The rates were not significantly different for the diabetic (TLF, 3.0%; MACE, 14.1%; thrombosis, 1.0%), and small-vessel subgroups (TLF, 4.3%; MACE, 12.1%; thrombosis, 0%). Conclusions: In conclusion, the results of this observational registry on the use of Angiolite in a real-world population, including a high-risk population, corroborate the excellent results observed in previous studies, up to a 2-year follow-up. An extended 5-year follow-up is planned to discard the occurrence of late events

Aim Patients with diabetes mellitus are at high risk of adverse events after percutaneous revascularization, with no differences in outcomes between most contemporary drug-eluting stents. The Cre8 EVO stent releases a formulation of sirolimus with an amphiphilic carrier from laser-dug wells, and has shown clinical benefits in diabetes. We aimed to compare Cre8 EVO stents to Resolute Onyx stents (a contemporary polymer-based zotarolimus-eluting stent) in patients with diabetes. Methods and results We did an investigator-initiated, randomized, controlled, assessor-blinded trial at 23 sites in Spain. Eligible patients had diabetes and required percutaneous coronary intervention. A total of 1175 patients were randomly assigned (1:1) to receive Cre8 EVO or Resolute Onyx stents. The primary endpoint was target-lesion failure, defined as a composite of cardiac death, target-vessel myocardial infarction, and clinically indicated target-lesion revascularization at 1-year follow-up. The trial had a non-inferiority design with a 4% margin for the primary endpoint. A superiority analysis was planned if non-inferiority was confirmed. There were 106 primary events, 42 (7.2%) in the Cre8 EVO group and 64 (10.9%) in the Resolute Onyx group [hazard ratio (HR): 0.65, 95% confidence interval (CI): 0.44–0.96; P non-inferiority < 0.001; P superiority = 0.030]. Among the secondary endpoints, Cre8 EVO stents had significantly lower rate than Resolute Onyx stents of target-vessel failure (7.5% vs. 11.1%, HR: 0.67, 95% CI: 0.46–0.99; P = 0.042). Probable or definite stent thrombosis and all-cause death were not significantly different between groups. Conclusion In patients with diabetes, Cre8 EVO stents were non-inferior to Resolute Onyx stents with regard to target-lesion failure composite outcome. An exploratory analysis for superiority at 1 year suggests that the Cre8 EVO stents might be superior to Resolute Onyx stents with regard to the same outcome. Clinical trial registration ClinicalTrials.gov: NCT03321032.

Introduction and objectives: Coronary lesions with stent overlapping are associated with higher neointimal proliferation that leads to more restenosis. Furthermore, the tapering of coronary arteries is a major challenge when treating long coronary lesions. This study attempted to assess the safety and clinical level of performance of long nontapered sirolimus-eluting coronary stent systems (> 36 mm) to treat long and diffused de novo coronary lesions in real-world scenarios. Methods: This was a prospective, non-randomized, multicentre study that included 696 consecutive patients treated with the long nontapered BioMime sirolimus-eluting coronary stent system in long and diffused de novo coronary lesions. The safety endpoint was major adverse cardiovascular events defined as a composite of cardiac death, myocardial infarction, clinically driven target lesion revascularization, stent thrombosis, and major bleeding at the 12-month follow-up. Results: Of a total of 696 patients, 38.79% were diabetic. The mean age of all the patients was 64.6 ± 14 years, and 80% were males. The indication for revascularization was acute coronary syndrome in 63.1%. A total of 899 lesions were identified out of which 742 were successfully treated with long BioMime stents (37 mm, 40 mm, 44 mm, and 48 mm). The cumulative incidence of major adverse cardiovascular events was 8.1% at the 12-month follow-up including cardiac death (2.09%), myocardial infarction (1.34%), and total stent thrombosis (0.5%). Conclusions: This study confirms the safety and good performance of long nontapered BioMime coronary stents to treat de novo coronary stenosis. Therefore, it can be considered a safe and effective treatment for long and diffused de novo coronary lesions in the routine clinical practice.

espanolIntroduccion y objetivos: El dispositivo Lotus (Boston Scientific, Estados Unidos) es una protesis valvular aortica transcateter de segunda generacion, completamente recuperable y reposicionable. Se presenta la experiencia inicial con la protesis Lotus en un registro multicentrico. Metodos: Estudio observacional que reporta los resultados a corto y largo plazo del implante transfemoral de protesis Lotus entre marzo de 2014 y abril de 2016 en 8 centros de Espana y Portugal. Resultados: Se incluyeron 102 pacientes (edad media 80,4 ± 6,1 anos, indice STS medio 5,2% ± 3,3%) con estenosis aortica grave sintomatica (area valvular media 0,66 ± 0,17 cm2, gradientes 74,3/45,6 mmHg). Se implanto con exito el dispositivo en 100 pacientes (98%), con mejoria significativa de los gradientes maximo y medio valvular, y un solo caso de regurgitacion periprotesica moderada. No hubo ninguna embolizacion ni necesidad de implante de una nueva protesis intravalvular. Hasta el alta hospitalaria, la mortalidad fue del 3,9% y la tasa de ictus fue del 2,9%. En 33 pacientes (32,3%) fue necesario el implante de marcapasos definitivo. Conclusiones: La valvula Lotus es eficaz y segura para el tratamiento de pacientes con estenosis aortica grave sintomatica. Destacan la escasa tasa de insuficiencia periprotesica y la ausencia de complicaciones derivadas del mal posicionamiento o la embolizacion de la protesis, a costa de un alta incidencia de implante de marcapasos. EnglishIntroduction and objectives: The Lotus Valve device (Boston Scientific) is a second-generation fully-retrievable and repositionable transcatheter aortic valve. We report the initial multicenter experience with the Lotus valve in the management of patients with severe aortic stenosis. Methods: Observational study that described the short and long-term results of implanting the Lotus valve in 8 Spanish and Portuguese centers from March 2014 through April 2016. Results: The study included 102 patients (mean age 80.4 ± 6.1 years; STS score 5.2% ± 3.3%) with severe symptomatic aortic stenosis (mean aortic valve area 0.66 ± 0.17 cm2, aortic gradients 74.3 / 45.6 mmHg). The valve was successfully implanted in 100 patients (98%), with significant improvement in both the peak and mean aortic valve gradients and with only one patient showing moderate paravalvular regurgitation. Upon hospital discharge, mortality rate was 3.9% while the stroke rate was 2.9%. No cases of valve embolization, ectopic valve deployment or additional valve implantation (valve-in-valve) were seen. Thirty-three patients (32.3%) received a permanent pacemaker. Conclusions: The Lotus Valve System is effective and safe for the management of patients with severe symptomatic aortic stenosis. In particular, considering the low rate of periprosthetic regurgitation and lack of complications like embolization or ectopic valve deployment; however at the expense of a high pacemaker implantation rate.

espanolIntroduccion y objetivos: El objetivo primario de este estudio fue presentar la mortalidad total intrahospitalaria del registro espanol de implante percutaneo de valvula aortica (TAVI) desde su inicio hasta el ano 2018, y como objetivos secundarios otros eventos clinicos intrahospitalarios, la mortalidad total a los 30 dias y la evaluacion de cual ha sido la evolucion temporal de este registro. Metodos: Fueron analizados todos los pacientes consecutivos incluidos en el registro espanol de TAVI. En este analisis temporal se dividio la poblacion en pacientes tratados antes de 2014 (cohorte A: 2009-2013) y pacientes tratados entre los anos 2014 y 2018 (cohorte B). Resultados: Desde agosto de 2007 hasta junio de 2018 se incluyeron 7.180 pacientes. La edad media fue de 81,2 ± 6,5 anos y el 53% eran mujeres. El EuroSCORE logistico fue del 12% (8-20). Se utilizo un acceso transfemoral en el 89%. La mortalidad total intrahospitalaria fue del 4,7% y a los 30 dias fue del 5,7%. En el analisis temporal durante la fase hospitalaria, las tasas de infarto, accidente cerebrovascular, necesidad de marcapasos, taponamiento, obstruccion coronaria y complicaciones vasculares fueron similares en ambos grupos. Sin embargo, en la cohorte B se observo una reduccion de la necesidad de conversion a cirugia y de mala posicion de la valvula, y ademas la tasa de exito del implante fue mayor (93 frente a 96%; p Conclusiones: En el analisis temporal del registro espanol de TAVI se observan un cambio en el perfil clinico de los pacientes y una mejora en la evolucion clinica tanto intrahospitalaria como a los 30 dias en los pacientes tratados en los ultimos anos. EnglishIntroduction and objectives: This study primary endpoint was to present the in-hospital all-cause mortality of the Spanish TAVI registry from its inception until 2018. Secondary endpoints included other in-hospital clinical events, 30-day all-cause mortality, and an assessment of the time trend of this registry. Methods: All consecutive patients included in the Spanish TAVI registry were analyzed. In this time-based analysis, the population was been divided into patients treated before 2014 (cohort A: 2009-2013) and patients treated between 2014 and 2018 (cohort B). Results: From August 2007 to June 2018, 7180 patients were included. The mean age was 81.2 ± 6.5 years and 53% were women. The logistic EuroSCORE was 12% (8-20). Transfemoral access was used in 89%. In-hospital and 30-day all-cause mortality was 4.7% and 5.7%, respectively. On the time-based analyses during the hospital stay, the rate of myocardial infarction, stroke, need for pacemakers, tamponade, coronary obstruction, and vascular complications was similar between both groups. However, cohort B showed less need for conversion to surgery and malapposition of the valve. Also, the implant success rate increased from 93% to 96% (P Conclusions: The time trend analysis of the Spanish TAVI registry showed a change in the patients’ clinical profile and an improvement in the in-hospital clinical outcomes and 30-day all-cause mortality in patients treated more recently.

Background: The use of poly- l -lactide acid-based bioresorbable scaffolds is limited in daily clinical practice because of safety concerns and lack of physiological benefit. Magnesium-based bioresorbable scaffold (MgBRS) presents a short resorption period ( Methods: This investigator-driven, multicenter, randomized, single-blind, controlled trial randomized ST-segment–elevation myocardial infarction patients 1:1 to SES or MgBRS at 11 academic centers. The primary end point was the rate of increase (≥3%) after nitroglycerin in mean lumen diameter of the in-stent/scaffold segment at 12 months with superiority of MgBRS over SES in the as-treated population. The main secondary end points included angiographic parameters of restenosis, device-oriented composite end point, their individual components, and device thrombosis rate. Besides, endothelial-dependent vasomotor response to acetylcholine (ie, endothelial function) was also assessed in a subgroup of patients (n=69). Results: Between June 2017 and June 2018, 150 ST-segment–elevation myocardial infarction patients were randomized (MgBRS, n=74; SES, n=76). At 1 year, the primary end point was significantly higher in the MgBRS arm (56.5% versus 33.8%; P =0.010). Conversely, late lumen loss was significantly lower in the SES group (in-segment: 0.39±0.49mm versus 0.02±0.27mm, P P P =0.030). Definite thrombosis rate was similar between groups (1[1.4%] in the MgBRS arm versus 2[2.6%] in the SES group; P =1.0). Endothelial function assessment at device segment evidenced a more pronounced vasoconstrictive response to maximal dose of acetylcholine in the MgBRS arm (−8.3±3.5% versus −2.4±1.3% in the SES group, P =0.003). Conclusions: When compared to SES, MgBRS demonstrated a higher capacity of vasomotor response to pharmacological agents (either endothelium-independent or endothelium-dependent) at 1 year. However, MgBRS was associated with a lower angiographic efficacy, a higher rate of target lesion revascularization, without thrombotic safety concerns. Clinical Trial Registration: URL: https://www.clinicaltrials.gov . Unique identifier: NCT03234348.

Background Triple antithrombotic therapy (TT) is recommended for patients with nonvalvular atrial fibrillation (AF) undergoing percutaneous coronary intervention (PCI). However, there is a lack of comparative data in a real-world clinical setting between non-vitamin K antagonist oral anticoagulants (NOAC) and vitamin K antagonists (VKA). The aim of this study was to compare the safety and efficacy of TT with NOAC or VKA after PCI in patients with AF at 1-year of follow-up. Materials and Methods This was an observational retrospective study in 2 tertiary care hospitals during 2013-2016. Patients with indication for anticoagulation due to AF from an initial registry of 5,269 patients undergoing PCI were identified. Safety primary endpoint was the occurrence of major bleeding events as defined by Bleeding Academic Consortium (BARC ≥ 3). The primary efficacy endpoint was defined as major adverse cardiovascular events (MACE). Results A total of 187 consecutive patients on TT were identified: 45.4% of were discharged on NOAC and 54.6% on VKA. Patients who received VKA presented more comorbidities and had a higher bleeding risk than those who received NOACs. Major bleeding events occurred in 17 patients (9%), with a higher rate in the VKA group (3.5% vs. 13% confidence interval, 0.19-0.86, P = 0.02). There were no differences in the rates of major adverse cardiovascular events, stroke or net clinical benefit. Conclusions In this real-world study, patients with AF undergoing PCI treated on NOAC-based TT showed lower bleeding rates than those on VKA, with a lower rate of major bleeding events, while efficacy was similar between groups.

OBJECTIVES We investigated the safety and efficacy of the bioabsorbable polymer-coated, everolimus-eluting coronary stent (SYNERGY) stent in a real-world study population with acute coronary syndromes (ACS). BACKGROUND A number of clinical trials support the overall efficacy and safety of the SYNERGY stent. However, a recent trial (TIDES-ACS) in the context of ACS reported worrying figures of infarction and definite/probable stent thrombosis in the SYNERGY control arm. METHODS This is a multicenter registry (10 centers) including consecutive patients with ACS (unstable angina, non-ST elevated myocardial infarction, ST elevated myocardial infarction) who underwent percutaneous revascularization with the implantation of SYNERGY stent. The primary endpoint was the composite of cardiac death, myocardial infarction and target lesion revascularization at 12 months. RESULTS A total of 1008 patients were included with age 65.4 ± 14.8 years, 23.8% females and a 24.5% diabetics. Regarding presentation, a 15.2% with unstable angina, 43% with non-ST elevated myocardial infarction and 41.8% with ST elevated myocardial infarction. Primary outcome was met in 3% (7% in SYNERGY TIDES-ACS arm, P superiority

Background Limited data exists on the impact of sex on outcomes in non-valvular atrial fibrillation (NVAF) patients undergoing percutaneous coronary intervention (PCI). We explored the impact of sex on ischemic and bleeding events in these patients within 1-year. Methods A prospective register included 1021 patients with NVAF undergoing PCI and 253 (24.8%) were women. The primary end point was a composite of cardiovascular death, stroke or systemic embolism (SSE). The secondary end-point was major bleeding events defined as a Bleeding Academic Research Consortium (BARC ≥ 3a). Results Women were older (76.8 ± 7.7 vs 71.8 ± 9.1 years, p Conclusions Female with NVAF undergoing PCI showed a lower TTR than men and TTR was associated with bleeding events. Female sex was an independent risk factor for cardiovascular death and major bleeding.

Background: Drug-eluting stents (DES) reduce stent restenosis compared with bare-metal stents (BMS). However, their use in patients requiring long-term oral anticoagulation (OAC) is controversial owing to increased risk of bleeding associated with OAC plus antiplatelet treatment over time. Objective: To assess the safety of DES vs BMS in patients requiring long-term OAC for any reason. Methods: Prospective observational multicenter study conducted at 6 teaching centers of patients undergoing percutaneous coronary intervention who required OAC for any reason. Adverse outcomes were analyzed at 1 year of follow-up. Results: We identified 1002 patients requiring OAC (mean age: 72 years, male 72%). Six- hundred and thirteen patients (61.2%) received BMS and 389 (38.8%) DES. Diabetes, previous PCI, myocardial infarction and acute coronary syndrome at admission (P < 0.0001) were more common in patients with DES. Antithrombotic prescribing was similar at discharge between groups (TT: 51.5% vs 50.9%, clopidogrel plus OAC: 7.0% vs 5.0% and DAPT: 41.4% vs 42.7%, p = 0.52). DES and BMS patients showed similar rates of total bleeding (15.2% vs 13.4%, adjusted HR 0.82 [0.58–1.17, p = 0.82 and major bleeding (6.2% vs 6.0%; adjusted HR 1.22 [0.71–2.09], p = 0.46) and MACE (15.2% vs 18.6%, adjusted HR: 0.82 [0.57–1.17], p = 0.28, while restenosis was lower in patients with DES (5.3% vs 8.5%, adjusted HR. (0.52 [0.29–0.92], p = 0.02. Cox analysis after propensity score selection of 368 matched pairs demonstrated that DES use was not associated with a higher incidence of total bleeding or major bleeding. Conclusion: DES use is safe in patients with an indication for long-term OAC.

Resumen Introduccion y objetivos Aunque las guias de practica clinica recomiendan una estrategia invasiva para el infarto agudo de miocardio sin elevacion del segmento ST (IAMSEST), en la practica clinica esta estrategia se infrautiliza en ancianos fragiles. Ademas estos enfermos habitualmente quedan excluidos de los ensayos clinicos, por lo que la evidencia es escasa. Nuestra hipotesis es que una estrategia invasiva para el anciano con fragilidad y IAMSEST mejorara el pronostico. Metodos Se trata de un estudio prospectivo, multicentrico y aleatorizado que compara una estrategia invasiva frente a una conservadora en ancianos fragiles con IAMSEST. Los criterios de inclusion son: IAMSEST, edad ≥ 70 anos y fragilidad definida por al menos 4 criterios de la escala Clinical Frailty Scale. Se aleatorizara a los participantes a una estrategia invasiva (coronariografia y revascularizacion si se considera anatomicamente indicada) o conservadora (tratamiento medico y coronariografia solo en caso de inestabilidad clinica persistente). El objetivo principal sera el numero de dias vivo fuera del hospital durante el primer ano. El objetivo coprincipal sera el tiempo hasta la presentacion de muerte cardiovascular, reinfarto agudo de miocardio o revascularizacion tras el alta. El tamano de la muestra estimado es de 178 pacientes (89 por grupo), asumiendo un incremento del 20% en la proporcion de dias vivo fuera del hospital con la estrategia invasiva. Resultados Los resultados del estudio aportaran informacion novedosa para el tratamiento del anciano fragil con IAMSEST. Conclusiones Nuestra hipotesis es que una estrategia invasiva mejorara el pronostico de los pacientes ancianos fragiles con IAMSEST. Si esta hipotesis se confirmara, la situacion de fragilidad no deberia disuadir al cardiologo de indicar un tratamiento invasivo. Ensayo registrado en ClinicalTrials.gov (Identificador: NCT03208153 ).

Background Radiofrequency ablation (RF) of ventricular tachycardia (VT) due to intramural foci has a high recurrence rate. Several techniques, such as bipolar ablation, irrigated needle ablation catheter, and retrograde coronary venous ethanol ablation have been suggested. Transarterial coronary ethanol ablation (TCEA) can also be effective. We present a case series of TCEA guided with preprocedural imaging to correlated coronary arteries and the intramural substrate. Methods and results We present three consecutive patients with previous RF of septal VT (100% male; age, 72.6 ± 11.01 years; two patients with hypertrophic cardiomyopathy, one with mechanical aortic valve prosthesis) that underwent TCEA. Cardiac magnetic resonance was performed in two patients and cardiac CT in all patients. Correlation of septal arteries with intramural substrate was analyzed before the procedure so TCEA was attempted according to this analysis. After last TCEA (6.3 ± 2.08 months) the VT burden was reduced in all patients (sum of all implantable cardioverter-defibrillator therapies [antitachycardia pacing and shock] before and after TCEA, 15.8 ± 3.73 vs 0.97 ± 0.63 therapies/month; P = 0.02). No complications occurred during TCEA. Conclusions TCEA completely guided with previous magnetic resonance imaging and computed tomography scan to select the coronary artery in relation to the substrate seems to be feasible as an alternative strategy in cases of intramural VT refractory to RF ablation.

Background There is a paucity of outcome data on patients who are morbidly obese (MO) undergoing transcatheter aortic valve replacement. We aimed to determine their periprocedural and midterm outcomes and investigate the impact of obesity phenotype. Methods and Results Consecutive patients who are MO (body mass index, ≥40 kg/m 2 , or ≥35 kg/m 2 with obesity‐related comorbidities; n=910) with severe aortic stenosis who underwent transcatheter aortic valve replacement in 18 tertiary hospitals were compared with a nonobese cohort (body mass index, 18.5–29.9 kg/m 2 , n=2264). Propensity‐score matching resulted in 770 pairs. Pre–transcatheter aortic valve replacement computed tomography scans were centrally analyzed to assess adipose tissue distribution; epicardial, abdominal visceral and subcutaneous fat. Major vascular complications were more common (6.6% versus 4.3%; P =0.043) and device success was less frequent (84.4% versus 88.1%; P =0.038) in the MO group. Freedom from all‐cause and cardiovascular mortality were similar at 2 years (79.4 versus 80.6%, P =0.731; and 88.7 versus 87.4%, P =0.699; MO and nonobese, respectively). Multivariable analysis identified baseline glomerular filtration rate and nontransfemoral access as independent predictors of 2‐year mortality in the MO group. An adverse MO phenotype with an abdominal visceral adipose tissue:subcutaneous adipose tissue ratio ≥1 (VAT:SAT) was associated with increased 2‐year all‐cause (hazard ratio [HR], 3.06; 95% CI, 1.20–7.77; P =0.019) and cardiovascular (hazard ratio, 4.11; 95% CI, 1.06–15.90; P =0.041) mortality, and readmissions (HR, 1.81; 95% CI, 1.07–3.07; P =0.027). After multivariable analysis, a (VAT:SAT) ratio ≥1 remained a strong predictor of 2‐year mortality (hazard ratio, 2.78; P =0.035). Conclusions Transcatheter aortic valve replacement in patients who are MO has similar short‐ and midterm outcomes to nonobese patients, despite higher major vascular complications and lower device success. An abdominal VAT:SAT ratio ≥1 identifies an obesity phenotype at higher risk of adverse clinical outcomes.

Background: The BioFreedom drug-coated stent with a stainless steel platform (BF-SS) has been demonstrated to be efficacious in patients at high bleeding risk and receiving only one-month dual antiplatelet therapy. Aims: The aim of this study was to evaluate the efficacy of the new BioFreedom Ultra drug-coated stent with a thin-strut cobalt-chromium platform (BF-CoCr) compared to the BF-SS in an all-comers population undergoing percutaneous coronary intervention (PCI). Methods: This was a prospective, multicentre, non-inferiority trial. The primary endpoint was in-stent late lumen loss (LLL) as determined by quantitative coronary angiography at nine-month follow-up. Clinical evaluation was performed at one year. Results: A total of 200 patients were randomised (1:1) to either the BF-CoCr or the BF-SS stent at eight centres in Spain and Denmark. Baseline clinical and lesion characteristics were similar between the groups. Mean age was 66 years and 23% were female. The mean number of stents implanted per patient was 1.5. At nine-month follow-up, mean in-stent LLL was 0.34±0.49 mm in the BF-CoCr group versus 0.29±0.37 mm in the BF-SS group, p=0.005 for non-inferiority. At one year, target lesion failure was similar between the groups (7.3% in BF-CoCr vs 9.3% in the BF-SS group; p=0.60). Conclusions: The BF-CoCr was non-inferior to the BF-SS in terms of in-stent LLL at nine months. Larger studies powered for clinical endpoints are warranted to compare the efficacy of this new platform with currently available DES.

Background During COVID-19 pandemic, elective invasive cardiac procedures (ICP) have been frequently cancelled or postponed. Consequences may be more evident in patients with diabetes. Objectives The objective was to identify the peculiarities of patients with DM among those in whom ICP were cancelled or postponed due to the COVID-19 pandemic, as well as to identify subgroups in which the influence of DM has higher impact on the clinical outcome. Methods We included 2,158 patients in whom an elective ICP was cancelled or postponed during COVID-19 pandemic in 37 hospitals in Spain. Among them, 700 (32.4%) were diabetics. Patients with and without diabetes were compared. Results Patients with diabetes were older and had a higher prevalence of other cardiovascular risk factors, previous cardiovascular history and co-morbidities. Diabetics had a higher mortality (3.0% vs. 1.0%; p = 0.001) and cardiovascular mortality (1.9% vs. 0.4%; p = 0.001). Differences were especially important in patients with valvular heart disease (mortality 6.9% vs 1.7% [p Conclusion Among patients in whom an elective invasive cardiac procedure is cancelled or postponed during COVID-19 pandemic, mortality and cardiovascular mortality is higher in patients with diabetes, irrespectively on other clinical conditions. These procedures should not be cancelled in patients with diabetes.

Reemplaçament de la vàlvula aòrtica; Qualitat de vida; Qüestionari Reemplazo de la válvula aórtica; Calidad de vida; Cuestionario Aortic valve replacement; Quality of life; Questionnaire Aims There is no quality of life tool specifically developed for patients with severe aortic stenosis (AS) to assess how this chronic condition and its treatment affect patients. The Toronto Aortic Stenosis Quality of Life Questionnaire (TASQ) has been developed to overcome this gap. The results of the validation of the TASQ in patients undergoing treatment for severe AS are presented. Methods and results Prospective study at 10 centres in Europe and Canada, which enrolled 274 patients with severe symptomatic AS undergoing surgical or transcatheter aortic valve replacement. Mean TASQ score at baseline was 71.2 points and increased to 88.9 three months after aortic valve implantation (P < 0.001). Increases were seen for the emotional impact (32.0 to 39.0; P < 0.001), physical limitations (14.8 to 22.0; P < 0.001), and physical symptoms (8.5 vs. 11.0; P < 0.001) domains. Internal consistency was good/excellent for overall TASQ score (α = 0.891) and for the physical limitation, emotional impact, and social limitation domains (α = 0.815–0.950). Test–retest reliability was excellent or strong for the overall TASQ (intraclass correlation coefficient of 0.883) and for the physical symptoms, physical limitation, emotional impact, and social limitation domains (intraclass correlation coefficient of 0.791–0.895). Responsiveness was medium overall (Cohen's d = 0.637) and medium/large for physical symptoms, emotional impact, and physical limitations (0.661–0.812). Sensitivity to change was significant for physical symptoms, physical limitations (both P < 0.001), emotional impact (P = 0.003), and social limitations (P = 0.038). Conclusions The TASQ is a new, brief, self‐administered, and clinically relevant health‐specific tool to measure changes in quality of life in patients with AS undergoing an intervention. This work was supported by a research grant provided by Edwards Lifesciences (Nyon, Switzerland) to the Institute for Pharmacology and Preventive Medicine (Cloppenburg, Germany).

Remote ischemic conditioning (RIC) and the GLP-1 analog exenatide activate different cardioprotective pathways and may have additive effects on infarct size (IS). Here, we aimed to assess the efficacy of RIC as compared with sham procedure, and of exenatide, as compared with placebo, and the interaction between both, to reduce IS in humans. We designed a two-by-two factorial, randomized controlled, blinded, multicenter, clinical trial. Patients with ST-segment elevation myocardial infarction receiving primary percutaneous coronary intervention (PPCI) within 6 h of symptoms were randomized to RIC or sham procedure and exenatide or matching placebo. The primary outcome was IS measured by late gadolinium enhancement in cardiac magnetic resonance performed 3-7 days after PPCI. The secondary outcomes were myocardial salvage index, transmurality index, left ventricular ejection fraction and relative microvascular obstruction volume. A total of 378 patients were randomly allocated, and after applying exclusion criteria, 222 patients were available for analysis. There were no significant interactions between the two randomization factors on the primary or secondary outcomes. IS was similar between groups for the RIC (24 ± 11.8% in the RIC group vs 23.7 ± 10.9% in the sham group, P = 0.827) and the exenatide hypotheses (25.1 ± 11.5% in the exenatide group vs 22.5 ± 10.9% in the placebo group, P = 0.092). There were no effects with either RIC or exenatide on the secondary outcomes. Unexpected adverse events or side effects of RIC and exenatide were not observed. In conclusion, neither RIC nor exenatide, or its combination, were able to reduce IS in STEMI patients when administered as an adjunct to PPCI. The trial was sponsored with a Grant from Instituto de Salud Carlos III (PIE 13/00027) and a Grant from Generalitat de Catalunya (PERIS SLT/2381/2016). The sponsors have not been involved in the design, conduct, collection, analysis, interpretation of the data, nor in the preparation, review or approval of the manuscript Sí

Background Currently drug-eluting stents (DES) and drug-eluting balloons are recommended in patients with in-stent restenosis (ISR). However, the efficacy of bioresorbable vascular scaffolds (BVS) after scoring balloon (SCB) predilation in these patients is unknown. Methods RIBS VI (NCT02672878) and RIBS VI 'Scoring' (NCT03069066) are prospective multicentre studies assessing the value of BVS in patients with ISR. Inclusion and exclusion criteria were identical in both studies. Results of conventional BVS implantation (112 patients) were compared with those obtained with systematic SCB therapy before BVS (108 patients). Angiographic follow-up was scheduled for all patients. Results On late angiography (93% of eligible patients) the in-segment minimal lumen diameter (primary end-point) (1.88 +/- 0.5 vs. 1.90 +/- 0.4 mm, P = 0.81), % diameter stenosis (28 +/- 17 vs. 29 +/- 15%), late lumen loss (0.23 +/- 0.4 vs. 0.22 +/- 0.4 mm) and binary restenosis rate (8.5 vs. 9.3%) were similar in the conventional BVS and SCB + BVS groups, respectively. At 1-year follow-up (100% of patients) target lesion revascularization (TLR) requirement (9.8 vs. 11.1%) was similar with the two strategies. Freedom from cardiac death, myocardial infarction and TLR was 88% and 87%, respectively. Results remained unchanged after adjusting for potential baseline confounders and were consistent in 10 prespecified subgroups. Conclusion This study suggests that results of conventional BVS implantation in patients with ISR are not improved by systematic predilation with SCB. ID: NCT02672878 (RIBS VI) and NCT03069066 (RIBS VI 'Scoring'). Copyright (c) 2020 Wolters Kluwer Health, Inc. All rights reserved.

Introduction and objectives: Transaxillary access (TXA) has become the most widely used alternative to transfemoral access (TFA) in patients undergoing transcatheter aortic valve implantation (TAVI). The aim of this study was to compare total in-hospital and 30-day mortality in patients included in the Spanish TAVI registry who were treated by TXA or TFA access. Methods: We analyzed data from patients treated with TXA or TFA and who were included in the TAVI Spanish registry. In-hospital and 30-day events were defined according to the recommendations of the Valve Academic Research Consortium. The impact of the access route was evaluated by propensity score matching according to clinical and echocardiogram characteristics. Results: A total of 6603 patients were included; 191 (2.9%) were treated via TXA and 6412 via TFA access. After adjustment (n = 113 TXA group and n = 3035 TFA group) device success was similar between the 2 groups (94%, TXA vs 95%, TFA; P = .95). However, compared with the TFA group, the TXA group showed a higher rate of acute myocardial infarction (OR, 5.3; 95%CI, 2.0-13.8); P= .001), renal complications (OR, 2.3; 95%CI, 1.3-4.1; P = .003), and pacemaker implantation (OR, 1.6; 95%CI, 1.01-2.6; P = .03). The TXA group also had higher in-hospital and 30-day mortality rates (OR, 2.2; 95%CI, 1.04-4.6; P= .039 and OR, 2.3; 95%CI, 1.2-4.5; P = .01, respectively). Conclusions: Compared with ATF, TXA is associated with higher total mortality, both in-hospital and at 30 days. Given these results, we believe that TXA should be considered only in those patients who are not suitable candidates for TFA. (C) 2021 Sociedad Espanola de Cardiologia. Published by Elsevier Espana, S.L.U. All rights reserved.

BACKGROUND: During COVID-19 pandemic in Spain, elective procedures were canceled or postponed, mainly due to health care systems overwhelming. OBJECTIVE: The objective of this study was to evaluate the consequences of interrupting invasive procedures in patients with chronic cardiac diseases due to the COVID-19 outbreak in Spain. METHODS: The study population is comprised of 2,158 patients that were pending on elective cardiac invasive procedures in 37 hospitals in Spain on the 14th of March 2020, when a state of alarm and subsequent lockdown was declared in Spain due to the COVID-19 pandemic. These patients were followed-up until April 31th. RESULTS: Out of the 2,158 patients, 36 (1.7%) died. Mortality was significantly higher in patients pending on structural procedures (4.5% vs. 0.8%, respectively; p < .001), in those >80 year-old (5.1% vs. 0.7%, p < .001), and in presence of diabetes (2.7% vs. 0.9%, p = .001), hypertension (2.0% vs. 0.6%, p = .014), hypercholesterolemia (2.0% vs. 0.9%, p = .026) [Correction added on December 23, 2020, after first online publication: as per Dr. Moreno's request changes in p-values were made after original publication in Abstract.], chronic renal failure (6.0% vs. 1.2%, p < .001), NYHA > II (3.8% vs. 1.2%, p = .001), and CCS > II (4.2% vs. 1.4%, p = .013), whereas was it was significantly lower in smokers (0.5% vs. 1.9%, p = .013). Multivariable analysis identified age > 80, diabetes, renal failure and CCS > II as independent predictors for mortality. CONCLUSION: Mortality at 45 days during COVID-19 outbreak in patients with chronic cardiovascular diseases included in a waiting list due to cancellation of invasive elective procedures was 1.7%. Some clinical characteristics may be of help in patient selection for being promptly treated when similar situations happen in the future.

Objectives We sought to investigate stent healing and neointimal hyperplasia with ihtDEStiny drug-eluting stent (DES) by optical coherence tomography (OCT) examination conducted 9 months after implantation. Background The currently used DES present certain features that have been linked separately to their better performance in terms of efficacy and safety. Methods First-in-man, prospective and multicenter study including patients treated with ihtDEStiny stent undergoing OCT examination at 9 months follow up. The ihtDEStiny stent is a sirolimus eluting stent with an oval shape ultrathin struts (68 μm) and an abluminal coating of a fluoropolymer containing the antiplatelet agent triflusal. Primary endpoint was the percentage of obstruction of the in-stent volume by the neointima. Results In 58 patients (63 lesions) in-stent late lumen loss was 0.11 ± 0.23 mm (95% CI 0.05-0.16) with only in 6% of stents being > 0.5 mm and in-segment binary stenosis was 1.6%. In OCT mean neointima volume obstruction was 10.5 ± 6.9% with a mean neointima thickness of 110.9 ± 89.8 μm. The proportion of uncovered struts was 2.5%, malapposed struts 1.1% and malapposed/uncovered struts 0.7% and no subclinical thrombi detected. Mean incomplete stent apposition area was 0.1 ± 0.1 mm2. At 12 months target lesion revascularization rate was 3% and no stent thrombosis was reported. Conclusions In this study the ihtDEStiny stent has shown a very low degree of neointimal proliferation associated with a low rate of uncovered/malapposed struts and total absence of subclinical thrombi at 9 months follow up.

Objectives We sought to evaluate clinical outcomes in patients treated with the drug-eluting stent ihtDEStiny BD. Background The ihtDEStiny BD stent is a metallic sirolimus eluting stent with a biodegradable polymer with both drug and polymer coating the abluminal surface of the stent and balloon. Methods In this study, the clinical outcomes of a multicenter prospective registry of patients treated with this stent (DEStiny group) were analyzed and compared with those of a control group of patients treated with durable polymer everolimus or zotarolimus eluting stents (CONTROL group) paired by propensity score matching . Primary outcome was the target vessel failure (TVF) at 12 months defined as a composite of cardiac death, target vessel myocardial infarction (TV-MI) and target vessel revascularization (TVR). Results A total of 350 patients were included in the DESTtiny group. The control group consisted initially of 1368 patients, but after matching (1:1) 350 patients were selected as CONTROL group. The baseline clinical, angiographic and procedural characteristics were quite comparable in both groups. At 12 months follow up the TVF was 6.6% in DEStiny group and 6.3% in CONTROL group (p = 0.8). No differences were observed for any of the individual components of the primary endpoint: cardiac death 1.1% vs. 1.4%, TV-MI 3.4% vs. 3.7% and TVR 2.6% vs. 2.3% respectively. Conclusions The use of ihtDEStiny stent in real practice is associated with a clinical performance at 12 months follow up that appears to be non-inferior to the most widely used and largely evidence supported durable polymer drug eluting stents. A longer follow up is warranted.

Health-related quality of life (HRQoL) is impaired in patients with stable angina but patients often present with other forms of chest pain. The aim of this study was to compare the pre-diagnostic HRQoL in patients with suspected coronary artery disease (CAD) according to angina type, gender, and presence of obstructive CAD.From the pilot study for the European DISCHARGE trial, we analysed data from 24 sites including 1263 patients (45.9% women, 61.1 ± 11.3 years) who were clinically referred for invasive coronary angiography (ICA; 617 patients) or coronary computed tomography angiography (CTA; 646 patients). Prior to the procedures, patients completed HRQoL questionnaires: the Short Form (SF)-12v2, the EuroQoL (EQ-5D-3 L) and the Hospital Anxiety and Depression Scale.Fifty-five percent of ICA and 35% of CTA patients had typical angina, 23 and 33% had atypical angina, 18 and 28% had non-anginal chest discomfort and 5 and 5% had other chest discomfort, respectively. Patients with typical angina had the poorest physical functioning compared to the other angina groups (SF-12 physical component score; 41.2 ± 8.8, 43.3 ± 9.1, 46.2 ± 9.0, 46.4 ± 11.4, respectively, all age and gender-adjusted p 0.01), and highest anxiety levels (8.3 ± 4.1, 7.5 ± 4.1, 6.5 ± 4.0, 4.7 ± 4.5, respectively, all adjusted p 0.01). On all other measures, patients with typical or atypical angina had lower HRQoL compared to the two other groups (all adjusted p 0.05). HRQoL did not differ between patients with and without obstructive CAD while women had worse HRQoL compared with men, irrespective of age and angina type.Prior to a diagnostic procedure for stable chest pain, HRQoL is associated with chest pain characteristics, but not with obstructive CAD, and is significantly lower in women.Clinicaltrials.gov, NCT02400229.

Introduction and objectives The COVID-19 outbreak has had an unclear impact on the treatment and outcomes of patients with ST-segment elevation myocardial infarction (STEMI). The aim of this study was to assess changes in STEMI management during the COVID-19 outbreak. Methods Using a multicenter, nationwide, retrospective, observational registry of consecutive patients who were managed in 75 specific STEMI care centers in Spain, we compared patient and procedural characteristics and in-hospital outcomes in 2 different cohorts with 30-day follow-up according to whether the patients had been treated before or after COVID-19. Results Suspected STEMI patients treated in STEMI networks decreased by 27.6% and patients with confirmed STEMI fell from 1305 to 1009 (22.7%). There were no differences in reperfusion strategy (> 94% treated with primary percutaneous coronary intervention in both cohorts). Patients treated with primary percutaneous coronary intervention during the COVID-19 outbreak had a longer ischemic time (233 [150-375] vs 200 [140-332] minutes, P

AIMS The MAGSTEMI trial showed larger endothelium-independent vasodilatation with magnesium-based bioresorbable scaffolds (MgBRS) than with sirolimus-eluting stents (SES). However, restenosis was more frequent with MgBRS. The aims of this study were to compare the healing pattern between MgBRS and SES and to describe the main causes of restenosis, as assessed by optical coherence tomography (OCT). METHODS AND RESULTS Ninety-five consecutive patients from the randomised MAGSTEMI trial (MgBRS=48, SES=47) underwent OCT imaging at one year. Healing and bioresorption pattern were categorised into four groups: 1) indiscernible struts were observed in 33.3% versus 0% of patients (p

Background: Transfemoral approach has been commonly used as secondary access in transcatheter aortic valve replacement (TAVR). Scarce data exist on the use and potential clinical benefits of the transradial approach as secondary access during TAVR procedures. The objective of the study is to determine the occurrence of vascular complications (VC) and clinical outcomes according to secondary access (transfemoral versus transradial) in patients undergoing TAVR. Methods: This was a multicenter study including 4949 patients who underwent TAVR (mean age, 81±8 years, mean Society of Thoracic Surgeons score, 4.9 [3.3–7.5]). Transfemoral and transradial approaches were used as secondary access in 4016 (81.1%) and 933 (18.9%) patients, respectively. The 30-day clinical events (vascular and bleeding complications, stroke, acute kidney injury, and mortality) were evaluated and defined according to Valve Academic Research Consortium-2 criteria. Clinical outcomes were analyzed according to the secondary access (transfemoral versus transradial) in the overall population and in a propensity score-matched population involving 2978 transfemoral and 928 transradial patients. Results: Related-access VC occurred in 834 (16.9%) patients (major VC, 5.7%) and were related to the secondary access in 172 (3.5%) patients (major VC, 1.3%). The rate of VC related to the secondary access was higher in the transfemoral group (VC, 4.1% versus 0.9%, P P P P P P =0.043), acute kidney injury (transfemoral: 9.9%, transradial: 5.7%; P P =0.047). Conclusions: The use of transradial approach as secondary access in TAVR procedures was associated with a significant reduction in vascular and bleeding complications and improved 30-day outcomes. Future randomized studies are warranted.

Stent designs with ultrathin struts may further increase the procedural success of challenging lesion subsets. The objective of this study was to assess the safety and efficacy of ultrathin strut, polymer-free sirolimus eluting stent (PF-SES) implantations in a large scale, unselected patient population. Adult patients underwent percutaneous coronary interventions (PCI) with a thin-strut PF-SES. Data from two all-comers observational studies having the same protocol (ClinicalTrials.gov Identifiers: NCT02629575 and NCT02905214) were pooled. The accumulated target lesion revascularization (TLR) rate at 9-12 months was the primary endpoint. All dual antiplatelet therapy strategies according to the applicable guidelines were permissible. In total, 7243 patients were prospectively enrolled for PCI with PF-SES in stable coronary artery disease or acute coronary syndrome (ACS). Major risk factors in the overall cohort were diabetes (37.3%), ST elevation myocardial infarction (18.1%) and non-ST myocardial infarction (24.6%). The follow-up rate was 88.6% in the overall population. The TLR rate in the overall cohort was 2.2% whereas definite/probable stent thrombosis (ST) occurred in 0.7%. In patients with in-stent restenosis lesions, the major adverse cardiac events rate was 6.4% whereas the corresponding rate for isolated left main coronary artery (LMCA) disease was highest with 6.7% followed by patients with culprit lesions in vein bypasses (VB, 7.1%). The mortality rate in patients treated in VB lesions was highest with 5.4%, followed by the isolated LMCA subgroup (3.4%) and ACS (2.6%). PCI with PF-SES in an unselected patient population, is associated with low clinical event and ST rates. Furthermore, PF-SES angioplasty in niche indications demonstrated favorable safety and efficacy outcomes with high procedural success rates.

Background: Scarce data exist on coronary events following transcatheter aortic valve replacement (TAVR), and no study has determined the factors associated with poorer outcomes in this setting. This study sought to determine the clinical characteristics, outcomes, and prognostic factors of acute coronary syndrome (ACS) events following TAVR. Methods: Multicenter cohort study including a total of 270 patients presenting an ACS after a median time of 12 (interquartile range, 5–17) months post-TAVR. Post-ACS death, myocardial infarction, stroke, and overall major adverse cardiovascular or cerebrovascular events were recorded. Results: The ACS clinical presentation consisted of non–ST-segment–elevation myocardial infarction (STEMI) type 2 (31.9%), non–STEMI type 1 (31.5%), unstable angina (28.5%), and STEMI (8.1%). An invasive strategy was used in 163 patients (60.4%), and a percutaneous coronary intervention was performed in 97 patients (35.9%). Coronary access issues were observed in 2.5% and 2.1% of coronary angiography and percutaneous coronary intervention procedures, respectively. The in-hospital mortality rate was 10.0%, and at a median follow-up of 17 (interquartile range, 5–32) months, the rates of death, stroke, myocardial infarction, and major adverse cardiovascular or cerebrovascular events were 43.0%, 4.1%, 15.2%, and 52.6%, respectively. By multivariable analysis, revascularization at ACS time was associated with a reduction of the risk of all-cause death (hazard ratio, 0.54 [95% CI, 0.36–0.81] P =0.003), whereas STEMI increased the risk of all-cause death (hazard ratio, 2.06 [95% CI, 1.05–4.03] P =0.036) and major adverse cardiovascular or cerebrovascular events (hazard ratio, 1.97 [95% CI, 1.08–3.57] P =0.026). Conclusions: ACS events in TAVR recipients exhibited specific characteristics (ACS presentation, low use of invasive procedures, coronary access issues) and were associated with a poor prognosis, with a very high in-hospital and late death rate. STEMI and the lack of coronary revascularization determined an increased risk. These results should inform future studies to improve both the prevention and management of ACS post-TAVR.

Background: Health-related quality of life (HRQoL) is impaired in patients with stable angina but patients often present with other forms of chest pain. The aim of this study was to compare the pre-diagnostic HRQoL in patients with suspected coronary artery disease (CAD) according to angina type, gender, and presence of obstructive CAD.Methods: From the pilot study for the European DISCHARGE trial, we analysed data from 24 sites including 1263 patients (45.9% women, 61.1 ± 11.3 years) who were clinically referred for invasive coronary angiography (ICA; 617 patients) or coronary computed tomography angiography (CTA; 646 patients). Prior to the procedures, patients completed HRQoL questionnaires: the Short Form (SF)-12v2, the EuroQoL (EQ-5D-3 L) and the Hospital Anxiety and Depression Scale.Results: Fifty-five percent of ICA and 35% of CTA patients had typical angina, 23 and 33% had atypical angina, 18 and 28% had non-anginal chest discomfort and 5 and 5% had other chest discomfort, respectively. Patients with typical angina had the poorest physical functioning compared to the other angina groups (SF-12 physical component score; 41.2 ± 8.8, 43.3 ± 9.1, 46.2 ± 9.0, 46.4 ± 11.4, respectively, all age and gender-adjusted p p p Conclusions: Prior to a diagnostic procedure for stable chest pain, HRQoL is associated with chest pain characteristics, but not with obstructive CAD, and is significantly lower in women.Trial registration: Clinicaltrials.gov, NCT02400229.

Objectives The objective of this post hoc analysis was to analyze real-world dual antiplatelet therapy (DAPT) regimens following polymer-free sirolimus-eluting stent (PF-SES) implantations in an unselected patient population. Methods Patient-level data from two all-comers observational studies (ClinicalTrials.gov Identifiers: NCT02629575 and NCT02905214) were pooled and analyzed in terms of their primary endpoint. During the data verification process, we observed substantial deviations from DAPT guideline recommendations. To illuminate this gap between clinical practice and guideline recommendations, we conducted a post hoc analysis of DAPT regimens and clinical event rates for which we defined the net adverse event rate (NACE) consisting of target lesion revascularization (TLR, primary endpoint of all-comers observational studies) all-cause death, myocardial infarction (MI), stent thrombosis (ST), and bleeding events. A logistic regression was utilized to determine predictors why ticagrelor was used in stable coronary artery disease (CAD) patients instead of the guideline-recommended clopidogrel. Results For stable CAD, the composite endpoint of clinical, bleeding, and stent thrombosis, i.e., NACE, between the clopidogrel and ticagrelor treatment groups was not different (5.4% vs. 5.1%, p = 0.745). Likewise, in the acute coronary syndrome (ACS) cohort, the NACE rates were not different between both DAPT strategies (9.2% vs. 9.3%, p = 0.927). There were also no differences in the accumulated rates for TLR, myocardial infarction ([MI], mortality, bleeding events, and stent thrombosis in elective and ACS patients. The main predictors for ticagrelor use in stable CAD patients were age Conclusion Within the framework of a post hoc analysis based on a real-world, large cohort study, there were no differences in the combined endpoint of major adverse cardiac events (MACE), bleeding and thrombotic events for clopidogrel and ticagrelor in stable CAD or ACS patients. Despite the recommendation for clopidogrel by the European Society of Cardiology (ESC), real-world ticagrelor use was observed in subgroups of stable CAD patients that ought to be explored in future trials.

Background The objective of this study was to assess regional and ethnic differences in an unselected patient population treated with polymer-free sirolimus-eluting stents (PF-SES) in Asia and Europe. Methods Two all-comers observational studies based on the same protocol (ClinicalTrials.gov Identifiers: NCT02629575 and NCT02905214) were combined for data analysis to assure sufficient statistical power. The primary endpoint was the accumulated target lesion revascularization (TLR) rate at 9-12 months. Results Of the total population of 7243 patients, 44.0% (3186) were recruited in the Mediterranean region and 32.0% (2317) in central Europe. The most prominent Asian region was South Korea (17.6%, 1274) followed by Malaysia (5.7%, 413). Major cardiovascular risk factors varied significantly across regions. The overall rates for accumulated TLR and MACE were low with 2.2% (140/6374) and 4.4% (279/6374), respectively. In ACS patients, there were no differences in terms of MACE, TLR, MI and accumulated mortality between the investigated regions. Moreover, dual antiplatelet therapy (DAPT) regimens were substantially longer in Asian countries even in patients with stable coronary artery disease as compared to those in Europe. Conclusions PF-SES angioplasty is associated with low clinical event rates in all regions. Further reductions in clinical event rates seem to be associated with longer DAPT regimens.

Aim Patients with diabetes mellitus (DM) undergoing percutaneous coronary intervention (PCI) remain at high risk of cardiovascular events despite the use of contemporary drug-eluting stents (DES). This trial aim to compare the clinical efficacy of 2 novel second-generation DES in patients with DM. Methods and results The Second-Generation Drug-Eluting Stents in Diabetes (SUGAR) trial (ClinicalTrials.gov NCT03321032) is an investigator-initiated, prospective, randomized, controlled, multicenter study conducted exclusively in patients with DM. This study allows inclusion of the entire spectrum of patients with DM undergoing PCI, and the only exclusion criteria are shock at presentation, inability to consent or a life expectancy

Objectives This was a first-in-human study to assess the feasibility, safety, and exploratory efficacy of interatrial shunting for treating high-risk heart failure (HF) in patients with reduced and preserved ejection fraction. Methods A single-arm open-label study of patients with New York Heart Association functional class III or IV HF on optimal therapy was performed at 6 centers. The V-Wave shunt, an hourglass-shaped implant containing a 1-way bioprosthetic valve, was implanted by transseptal catheterization. Clinical, functional, echocardiographic, and hemodynamic evaluations were performed at baseline, 3 and 12 months, and annually (clinical follow-up) thereafter (median follow-up 28 months; interquartile range: 21 to 31 months). Results A total of 38 patients were enrolled (30 with HF with reduced ejection fraction and 8 with HF with preserved ejection fraction; mean age 66 ± 9 years; 97% and 3% in New York Heart Association functional classes III and IV, respectively), and the shunt device was successfully implanted in all cases without periprocedural mortality. The rate of major device- or procedure-related complications during the first 12 months was 2.6% (periprocedural cardiac tamponade in 1 patient). At 3- and 12-month follow-up, there were improvements in New York Heart Association functional class (classes I and II in 78% and 60% of patients, respectively), quality of life (improvements ≥5 points in 74% and 73% of patients, respectively), and 6-min walk distance (mean increases of 41 ± 63 m and 28 ± 83 m, respectively) (p Conclusions Interatrial shunting with the V-Wave system was feasible and safe in patients with HF with reduced and preserved ejection fraction. Improvements in clinical and functional status were observed early and at 12 months despite attenuation of shunt patency in one-half of the patients. Patients with preserved shunt patency tended to maintain clinical benefit during longer term follow-up. Device modification that improves the durability of patency is likely worthwhile before confirmation of these findings in a randomized trial.

The aim of this study was to evaluate the prognostic value of strain as assessed by tissue tracking (TT) cardiac magnetic resonance (CMR) soon after ST-segment elevation myocardial infarction (STEMI).The prognostic value of myocardial strain as assessed post-STEMI by TT-CMR is unknown.The authors studied the prognostic value of TT-CMR in 323 patients who underwent CMR 1 week post-STEMI. Global (average of peak segmental values [%]) and segmental (number of altered segments) longitudinal (LS), circumferential, and radial strain were assessed using TT-CMR. Global and segmental strain cutoff values were derived from 32 control patients. CMR-derived left ventricular ejection fraction, microvascular obstruction, and infarct size were determined. Results were validated in an external cohort of 190 STEMI patients.During a median follow-up of 1,085 days, 54 first major adverse cardiac events (MACE), which included 10 cardiac deaths, 25 readmissions for heart failure, and 19 readmissions for reinfarction were documented. MACE was associated with more severe abnormalities in all strain indexes (p 0.001), although only global LS was an independent predictor (p 0.001). The MACE rate was higher in patients with a global LS of ≥-11% (22% vs. 9%; p = 0.001). After adjustment for baseline and CMR variables, global LS (hazard ratio [HR]: 1.21; 95% confidence interval [CI]: 1.11 to 1.32; p 0.001) was associated with MACE. In the external validation cohort, a global LS ≥-11% was seen in a higher proportion of patients with MACE (34% vs. 9%; p 0.001). Global LS predicted MACE after adjustment for baseline and CMR variables (HR: 1.18; 95% CI: 1.04 to 1.33; p = 0.008). The addition of global LS to the multivariate models, including baseline and CMR variables, did not significantly improve the categorical net reclassification improvement index in either the study group (-0.015; p = 0.7) or in the external validation cohort (-0.019; p = 0.9).TT-CMR provided prognostic information soon after STEMI. However, it did not substantially improve risk reclassification beyond traditional CMR indexes.

Aim Use of a Bioresorbable Scaffolds (BRS) either in clinical practice or in the setting of an acute myocardial infarction (MI) is controversial. Despite an overall high rate of thrombosis, vascular healing response following BRS implantation tend to superiority as compared to metallic drug-eluting stent in ST-segment elevation myocardial infarction (STEMI) patients. We sought to compare the in-stent/scaffold vasomotion between metallic BRS and sirolimus eluting stent (SES) at 12-month angiographic follow-up in the setting of patients with STEMI treated by primary PCI. Study design This is an investigator-driven, prospective, multicenter, randomized, single blind, two-arm, controlled trial (ClinicalTrials.gov number: NCT03234348). This trial will randomize ~148 patients 1:1 to SES or BRS. Primary end-point is the in-stent/scaffold change in mean lumen diameter after nitroglycerin administration at 12-month angiographic follow-up. Besides, patient-oriented combined endpoint of all-cause death, any MI, and any revascularization, together with scaffold/stent thrombosis rate and device-oriented endpoint of cardiac death, target vessel (TV)-MI and TVR at 1 year will be also evaluated. Clinical follow-up will be scheduled yearly up to 5 years. Conclusion This trial will shed light on the vascular vasomotion following BRS implantation in the complex scenario of STEMI.

Objectives To assess the efficacy and safety of the Xience Prime everolimus-eluting stent (EES) in long coronary lesions in a real-world population. Background Long lesions are considered difficult technically and in terms of achieving successful clinical outcomes. With first generation DES, MACE can be as high as 10% at a short-medium term follow-up. There are a few data available in this subset regarding the use of second generation DES METHODS: A prospective, multicenter registry of consecutive patients (aged 64.8 ± 11.2 years, 77% men and 33% diabetics) in 29 tertiary hospitals with de novo > 24 mm lesions in vessels of 2.25-4 mm was performed. The primary and secondary endpoints were major adverse cardiac events (MACE; cardiac death, myocardial infarction, and target lesion revascularization) and stent thrombosis (ST) at 1, 12, and 24 months. Patients were on dual antiplatelet therapy during 12 months. Results A total of 610 patients with 705 long lesions were included (1.2 per patient). Lesion length was 34.59 ± 11.17 mm and vessel size 2.93 ± 0.41 mm. Stented length was 39.83 ± 14.08 mm (1.4 stents per lesion). Predilatation/postdiltatation was performed in 75 and 33% of the cases, intravascular ultrasound in 15%. The device success rate was 99.1%. MACE and ST rates at 1, 12, and 24-months follow-up were 0.3, 2.1, and 5.4% and 0.2, 0.7, and 1.5%, respectively. Conclusion In this real-world population, the Xience Prime EES performs extremely well in long lesions, with a very low rate of both MACE and ST.