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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 successlisted ful TAVR. The primary efficacy outcome was a composite of adverse events conavailable sisting 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 ZO 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.). [ABSTRACT FROM AUTHOR]

Background: Patients with aortic stenosis may continue to have an increased risk of heart failure, arrhythmias, and death after successful transcatheter aortic valve implantation. Renin-angiotensin system inhibitors may be beneficial in this setting. We aimed to explore whether ramipril improves the outcomes of patients with aortic stenosis after transcatheter aortic valve implantation., Methods and Results: PROBE (Prospective Randomized Open, Blinded Endpoint) was a multicenter trial comparing ramipril with standard care (control) following successful transcatheter aortic valve implantation in patients with left ventricular ejection fraction >40%. The primary end point was the composite of cardiac mortality, heart failure readmission, and stroke at 1-year follow-up. Secondary end points included left ventricular remodeling and fibrosis. A total of 186 patients with median age 83 years (range 79-86), 58.1% women, and EuroSCORE-II 3.75% (range 3.08-4.97) were randomized to receive either ramipril (n=94) or standard treatment (n=92). There were no significant baseline, procedural, or in-hospital differences. The primary end point occurred in 10.6% in the ramipril group versus 12% in the control group ( P =0.776), with no differences in cardiac mortality (ramipril 1.1% versus control group 2.2%, P =0.619) but lower rate of heart failure readmissions in the ramipril group (3.2% versus 10.9%, P =0.040). Cardiac magnetic resonance analysis demonstrated better remodeling in the ramipril compared with the control group, with greater reduction in end-systolic and end-diastolic left ventricular volumes, but nonsignificant differences were found in the percentage of myocardial fibrosis., Conclusions: Ramipril administration after transcatheter aortic valve implantation in patients with preserved left ventricular function did not meet the primary end point but was associated with a reduction in heart failure re-admissions at 1-year follow-up., Registration: URL: https://www.clinicaltrials.gov; Unique Identifier: NCT03201185.

Background and Objective: Fractional Flow Reserve (FFR) is generally considered the gold standard in hemodynamics to assess the impact of a stenosis on the blood flow. The standard procedure to measure involves the displacement of a pressure guide along the circulatory system until it is placed next to the lesion to be analyzed. The main objective of the present study is to analyze the influence of the pressure guide on the invasive FFR measurements and its implications in clinical practice., Methods: We studied the influence of pressure wires on the measurement of Fractional Flow Reserve (FFR) through a combination of Computational Fluid Dynamics (CFD) simulations using 45 clinical patient data with 58 lesions and ideal geometries. The analysis is conducted considering patients that were subjected to a computer tomography and also have direct measurements using a pressure guide. Influence of the stenosis severity, degree of occlusion and blood viscosity has also been studied., Results: The influence of pressure wires specifically affects severe stenosis with a lumen diameter reduction of 50 % or greater. This type of stenosis leads to reduced hyperemic flow and increased coronary pressure drop. Thus, we identified that the placement of wires during FFR measurements results in partial obstruction of the coronary artery lumen, leading to increased pressure drop and subsequent reduction in blood flow. The severity of low FFR values associated with severe stenosis may be prone to overestimation when compared to stenosis without severe narrowing. These results have practical implications, particularly in the interpretation of lesions falling within the "gray zone" (0,75-0,80)., Conclusions: The pressure wire's presence significantly alters the flow on severe lesions, which has an impact on the FFR calculation. In contrast, the impact of the pressure wire appears to be reduced when the FFR is larger than 0.8. The findings provide critical information for physicians, emphasizing the need for cautious interpretation of FFR values, particularly in severe stenosis. It also offers insights into improving the correlation between FFRct models and invasive measurements by incorporating the influence of pressure wires., Competing Interests: Declaration of competing interest All authors declare that they have no conflicts of interest., (Copyright © 2024. Published by Elsevier B.V.)

Background: 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., Aims: Our aim was to compare the periprocedural and mid-term outcomes in MO patients undergoing TAVR versus SAVR., Methods: A multicentre retrospective study including consecutive MO patients (body mass index ≥40 kg/m 2 , or ≥35 kg/m 2 with obesity-related comorbidities) from 18 centres undergoing either TAVR (n=860) or biological SAVR (n=696) for severe AS was performed. Propensity score matching resulted in 362 pairs., Results: After matching, periprocedural complications, including blood transfusion (14.1% versus 48.1%; p<0.001), 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%; p<0.001). TAVR patients more frequently required permanent pacemaker implantation (14.4% versus 5.6%; p<0.001) 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 p>0.05 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)., Conclusions: SAVR and TAVR offer similar mid-term outcomes in MO patients with severe AS, however, TAVR offers some advantages in terms of periprocedural morbidity.

Background: 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., Methods: 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., Results: Among the 2004 patients, 393 (19.6%) had a GFR <60 ml/min, and 1611 (80.4%) had a GFR ≥ 60 ml/min at discharge. Among patients with GFR <60 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., Conclusions: 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., Competing Interests: Conflicts of interest None., (Copyright © 2022 Hellenic Society of Cardiology. Published by Elsevier B.V. All rights reserved.)

Background: Hypertension is a prevalent condition among SARS-CoV-2 infected patients. Whether renin-angiotensin-aldosterone system (RAAS) inhibitors are beneficial or harmful is controversial., Methods: 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., Results: 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., Conclusion: 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., (© 2021 Elsevier España, S.L.U. All rights reserved.)

Aim: Whether Takotsubo syndrome (TTS) should be classified within myocardial infarction with non-obstructive coronary arteries (MINOCAs) is still controversial. The aim of this work was to evaluate the main differences between TTS and non-TTS MINOCAs., Methods and Results: A cohort study based on two prospective registries: TTS from the RETAKO registry ( N :1,015) and patients with non-TTS MINOCAs from contemporary records of acute myocardial infarction from five 5 national centers ( N :1,080). Definitions and management recommended by the ESC were used. Survival analysis was based on the Cox regression analysis; propensity score matching (PS) was created to adjust prognostic variables. Takotsubo syndrome were more often women (85.9 vs. 51.9%; p < 0.001) and older (69.4 ± 12.5 vs. 64.5 ± 14.1 years; p < 0.001). Atrial fibrillation (AF) was more frequent in non-TTS MINOCAs (10.4 vs. 14.4%; p = 0.007). Psychiatric disorders were more prevalent in TTS (15.5 vs. 10.2%, p < 0.001). In-hospital mortality and complications were higher in TTS: 3.4 vs. 1.8%, ( p = 0.015), and 25.8 vs. 11.5%, ( p < 0.001). Global mortality before PS matching was 16.1% in non-TTS MINOCAs and 8.1% in TTS. Median follow-up was 32.4 months; after PS matching, TTS had fewer major adverse cardiovascular events (MACEs): hazard ratio (HR) 0.59; 95% CI 0.42-0.83. There were no differences in global mortality (HR 0.87; CI: 0.64-1.19), but TTS had lower cardiovascular mortality (HR 0.58; CI: 0.35-0.98)., Conclusion: Compared to the rest of MINOCAs, TTS presents a different patient profile and a more aggressive acute phase. However, its long-term cardiovascular prognosis is better. These results support that TTS should be considered a separate entity with unique characteristics and prognosis., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. The reviewer RS-R declared a shared affiliation with one of the authors, IM to the handling editor at time of review., (Copyright © 2022 Lopez-Pais, Izquierdo Coronel, Raposeiras-Roubín, Álvarez Rodriguez, Vedia, Almendro-Delia, Sionis, Martin-Garcia, Uribarri, Blanco, Martín de Miguel, Abu-Assi, Galán Gil, Sestayo Fernández, Espinosa Pascual, Agra-Bermejo, López Otero, García Acuña, Alonso Martín, Gonzalez-Juanatey, Perez de Juan Romero and Núñez-Gil.)

Aims: Left ventricular ejection fraction (LVEF) recovery after an ST-segment elevation myocardial infarction (STEMI) identifies a group of patients with a better prognosis. However, the association between long-term outcomes and LVEF recovery among patients with STEMI undergoing primary percutaneous coronary intervention (PCI) has not yet been well investigated. Our study aims to detect differences in long-term all-cause and cardiovascular mortality between patients who recover LVEF at 1-year post-PCI and those who do not, and search for predictors of LVEF recovery., Methods and Results: This is a retrospective, single-centre study of 2170 consecutive patients admitted for STEMI in which primary PCI is performed. LVEF was determined at admission and at 1-year follow-up. The primary outcomes were long-term all-cause and cardiovascular mortality. Among the 2168 patients with baseline LVEF data, 822 (38%) had a LVEF < 50% and 1346 (62%) ≥ 50%. Among those with LVEF < 50%, LVEF data at 1-year were available in 554, and 299 (54.0%) presented with complete recovery (LVEF ≥ 50%). LVEF recovery was associated with a reduction in long-term all-cause and cardiovascular mortality (P < 0.0001). Female sex, treatment with ACEIs, lower creatinine levels, infarct-related artery different from the left main or left anterior descendent artery, and absence of prior ischaemic heart disease were independently associated with LVEF recovery., Conclusions: Nearly 40% of patients with STEMI undergoing primary PCI presented with LVEF depression at hospital admission. Among them, LVEF recovery at 1-year occurred in more than 50% and was independently associated with a significant decrease in long-term all-cause and cardiovascular mortality., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2021. For permissions, please email: journals.permissions@oup.com.)

Abstract: 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., Competing Interests: The authors declare no conflicts of interest., (Copyright © 2021 Wolters Kluwer Health, Inc. All rights reserved.)

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. 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. 893 patients were included. Median age was 68.2 ± 15.2 years. 87(9.7%) were admitted to Intensive Care Unit (ICU) and 72(8.1%) 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. 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.

Introduction and Objectives: Coronavirus disease (COVID-19) has been designated a global pandemic by the World Health Organization. It is unclear whether previous treatment with angiotensin-converting enzyme inhibitors (ACEI) and angiotensin receptor blockers (ARB) affects the prognosis of COVID-19 patients. The aim of this study was to evaluate the clinical implications of previous treatment with ACEI/ARB on the prognosis of patients with COVID-19 infection., Methods: Single-center, retrospective, observational cohort study based on all the inhabitants of our health area. Analyses of main outcomes (mortality, heart failure, hospitalization, intensive care unit [ICU] admission, and major acute cardiovascular events [a composite of mortality and heart failure]) were adjusted by multivariate logistic regression and propensity score matching models., Results: Of the total population, 447 979 inhabitants, 965 patients (0.22%) were diagnosed with COVID-19 infection, and 210 (21.8%) were under ACEI or ARB treatment at the time of diagnosis. Treatment with ACEI/ARB (combined and individually) had no effect on mortality (OR, 0.62; 95%CI, 0.17-2.26; P  = .486), heart failure (OR, 1.37; 95%CI, 0.39-4.77; P  = .622), hospitalization rate (OR, 0.85; 95%CI, 0.45-1.64; P  = .638), ICU admission (OR, 0.87; 95%CI, 0.30-2.50; P  = .798), or major acute cardiovascular events (OR, 1.06; 95%CI, 0.39-2.83; P  = .915). This neutral effect remained in a subgroup analysis of patients requiring hospitalization., Conclusions: Previous treatment with ACEI/ARB in patients with COVID-19 had no effect on mortality, heart failure, requirement for hospitalization, or ICU admission. Withdrawal of ACEI/ARB in patients testing positive for COVID-19 would not be justified, in line with current recommendations of scientific societies and government agencies., (© 2020 Sociedad Española de Cardiología. Published by Elsevier España, S.L.U. All rights reserved.)

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 <0.001). The change to non-nutritional risk after TAVR significantly impacted mortality (HR, 0.48 [95% CI, 0.30-0.78], 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 <0.001)., 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.

Background The clinical significance of conduction disturbances after transcatheter aortic valve implantation has been described; however, little is known about the influence of baseline ECGs in the prognosis of these patients. Our aim was to study the influence of baseline ECG parameters, including interatrial block (IAB), in the prognosis of patients treated with transcatheter aortic valve implantation. Methods and Results The BIT (Baseline Interatrial Block and Transcatheter Aortic Valve Implantation) registry included 2527 patients with aortic stenosis treated with transcatheter aortic valve implantation. A centralized analysis of baseline ECGs was performed. Patients were divided into 4 groups: normal P wave duration (<120 ms); partial IAB (P wave duration ≥120 ms, positive in the inferior leads); advanced IAB (P wave duration ≥120 ms, biphasic [+/-] morphology in the inferior leads); and nonsinus rhythm (atrial fibrillation/flutter and paced rhythm). The mean age of patients was 82.6±9.8 years and 1397 (55.3%) were women. A total of 960 patients (38.0%) had a normal P wave, 582 (23.0%) had partial IAB, 300 (11.9%) had advanced IAB, and 685 (27.1%) presented with nonsinus rhythm. Mean follow-up duration was 465±171 days. Advanced IAB was the only independent predictor of all-cause mortality (hazard ratio [HR], 1.48; 95% CI, 1.10-1.98 [ P =0.010]) and of the composite end point (death/stroke/new atrial fibrillation) (HR, 1.51; 95% CI, 1.17-1.94 [ P =0.001]). Conclusions Baseline ECG characteristics influence the prognosis of patients with aortic stenosis treated with transcatheter aortic valve implantation. Advanced IAB is present in about an eighth of patients and is associated with all-cause death and the composite end point of death, stroke, and new atrial fibrillation during follow-up.

Background: Coronavirus disease-2019 (COVID-19) is caused by severe acute respiratory-syndrome coronavirus-2 that interfaces with the renin-angiotensin-aldosterone system (RAAS) through angiotensin-converting enzyme 2. This interaction has been proposed as a potential risk factor in patients treated with RAAS inhibitors., Objectives: This study analyzed whether RAAS inhibitors modify the risk for COVID-19., Methods: The RASTAVI (Renin-Angiotensin System Blockade Benefits in Clinical Evolution and Ventricular Remodeling After Transcatheter Aortic Valve Implantation) trial is an ongoing randomized clinical trial randomly allocating subjects to ramipril or control groups after successful transcatheter aortic valve replacement at 14 centers in Spain. A non-pre-specified interim analysis was performed to evaluate ramipril's impact on COVID-19 risk in this vulnerable population., Results: As of April 1, 2020, 102 patients (50 in the ramipril group and 52 in the control group) were included in the trial. Mean age was 82.3 ± 6.1 years, 56.9% of the participants were male. Median time of ramipril treatment was 6 months (interquartile range: 2.9 to 11.4 months). Eleven patients (10.8%) have been diagnosed with COVID-19 (6 in control group and 5 receiving ramipril; hazard ratio: 1.150; 95% confidence interval: 0.351 to 3.768). The risk of COVID-19 was increased in older patients (p = 0.019) and 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% of patients (2 in the ramipril group and 3 in the control group), and 4 of them died (2 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 older patients with cardiovascular disease, randomization to ramipril had no impact on the incidence or severity of COVID-19. This analysis supports the maintenance of RAAS inhibitor treatment during the COVID-19 crisis. (Renin-Angiotensin System Blockade Benefits in Clinical Evolution and Ventricular Remodeling After Transcatheter Aortic Valve Implantation [RASTAVI]; NCT03201185)., (Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Introduction and Objectives: The purpose of this analysis was to assess the incidence, predictors and prognostic impact of acute heart failure (AHF) after transcatheter aortic valve implantation (TAVI) using a self-expanding prosthesis., Methods: From November 2008 to June 2017, all consecutive patients undergoing TAVI in our center were prospectively included in our TAVI registry. The predictive effect of AHF on all-cause mortality following the TAVI procedure was analyzed using Cox regression models., Results: A total of 399 patients underwent TAVI with a mean age of 82.4 ± 5.8 years, of which 213 (53.4%) were women. During follow-up (27.0 ± 24.1 months), 29.8% (n = 119) were admitted due to AHF, which represents a cumulative incidence function of 13.2% (95%CI, 11.1%-15.8%). At the end of follow-up, 150 patients (37.59%) had died. Those who developed AHF showed a significantly higher mortality rate (52.1% vs 31.4%; HR, 1.84; 95%; CI, 1.14-2.97; P = .012). Independent predictors of AHF after TAVI were a past history of heart failure (P = .019) and high Society of Thoracic Surgeons score (P = .004). We found that nutritional risk index and chronic obstructive pulmonary disease were strongly correlated with outcomes in the AHF group., Conclusions: TAVI was associated with a high incidence of clinical AHF. Those who developed AHF had higher mortality. Pre-TAVI AHF and high Society of Thoracic Surgeons score were the only independent predictors of AHF in our cohort. A low nutritional risk index and chronic obstructive pulmonary disease were independent markers of mortality in the AHF group., (Copyright © 2019 Sociedad Española de Cardiología. Published by Elsevier España, S.L.U. All rights reserved.)

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., (Copyright © 2019 Elsevier Inc. All rights reserved.)

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 (rSS >0 and <8), 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., (Copyright © 2018 Elsevier Inc. All rights reserved.)

Background: Among patients undergoing transcatheter aortic valve replacement (TAVR), prognosis is impacted by nutritional status, but the influence of the nutritional risk index (NRI) is unknown. Here we calculated the NRI to determine the prevalence and prognostic impact in terms of mortality of malnutrition in TAVR patients., Methods and Results: This retrospective multicenter study included 941 patients who underwent TAVR between 2008 and 2016 (mean age, 80.7 ± 6.5 years; 57% female). The NRI was calculated as 1.519 × albumin (g/L) + 41.7 × (real weight [kg] / ideal weight [kg]). The mean NRI was 98.1 ± 7.0%. The patients were stratified into the following groups based on malnutrition risk: severe (NRI < 83.5; n = 83; 8.82%), moderate (83.5 ≥ NRI < 97.5; n = 370; 39.32%), mild (97.5 ≥ NRI < 100; n = 102; 10.84%), and no risk (NRI ≥ 100; n = 386; 41.02%). During the follow-up period (2.1 ± 1.1 years), 186 patients died, representing 19.8% of the total cohort. Cox regression models were used to analyze the relationship between NRI and mortality during follow-up. Compared to patients with no or mild nutritional risk, those with moderate or severe nutritional risk had a 45% greater risk of mortality during follow-up (adjusted HR, 1.45; 95% CI, 1.05-1.99; P = 0.021)., Conclusion: Malnutrition is common among TAVR patients. Our present data indicated that the NRI was independently associated with increased risk of death during long-term follow-up after TAVR. Based on its potential to improve risk prediction, NRI appears to be a promising tool for the clinical assessment of patients who are candidates for TAVR., (Copyright © 2018 Elsevier B.V. All rights reserved.)

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., (Copyright © 2016 Sociedad Española de Cardiología. Published by Elsevier España, S.L.U. All rights reserved.)

Objectives: We aimed to determine whether body mass index (BMI) is a prognostic indicator for long-term, all-cause mortality in patients undergoing transcatheter aortic valve implantation (TAVI)., Background: Obesity in patients with established cardiovascular disease has previously been identified as an indicator of good prognosis, a phenomenon known as the "obesity paradox". The prognostic significance of BMI in patients with severe aortic stenosis (AoS) undergoing TAVI is a matter of current debate, as published studies are scarce and their results conflicting., Methods: This is an observational, retrospective study involving 770 patients who underwent TAVI for AoS. The cohort was divided into three groups based on their BMI: normal weight (≥18.5 to <25kg/m 2 ), overweight (≥25 to <30kg/m 2 ) and obese (≥30kg/m 2 ). The predictive effect of BMI on all-cause mortality 3years following TAVI intervention was analysed using a Cox regression., Results: 155 patients died during follow-up. The overweight group (n=302, 38.97%), experienced a lower mortality rate compared to the normal weight and obese groups (15.9% vs 25.7% and 21.0%, respectively [log-rank p-value=0.036]). After adjustment by logistic EuroSCORE, being overweight was found to be an independent protective factor against mortality (HR: 0.63 [95% CI: 0.42 to 0.94], p=0.024). This was not the case for obesity (HR: 0.92 [95% CI: 0.63 to 1.35], p=0.664). We therefore describe for the first time, a "J-shaped" regression curve describing the relationship between BMI and mortality., Conclusions: BMI is a predictive factor of all-cause mortality in AoS patients undergoing TAVI. This relationship takes the form of a "J-shaped" curve in which overweight patients are associated with the lowest mortality rate at follow-up., (Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.)

The platelet-specific collagen receptor glycoprotein VI (GPVI) is critical for the formation of arterial thrombosis in vivo. We analyzed GPVI-activated platelets from ST-elevation myocardial infarction (STEMI) patients and matched stable coronary artery disease (SCAD) controls in order to provide novel clues on the degree of involvement of GPVI signaling in the acute event. Firstly, platelets were isolated from systemic venous blood and activated with the GPVI specific agonist CRP (collagen-related peptide). STEMI and SCAD samples were compared by a phosphoproteomics approach. Validations were by immunoblotting in systemic and intracoronary blood from independent cohorts of patients. Twenty-six differentially regulated proteins were identified when comparing CRP-activated systemic platelets from STEMI and SCAD patients, 4 of which were selected for validation studies: PLCɣ2, G6f, SLP-76, and Dok-2. Immunoblot analyses showed these four proteins had higher tyrosine phosphorylation levels in response to CRP in platelets from STEMI patients, being these levels more pronounced at the culprit site of coronary artery occlusion. Moreover, platelet aggregation studies showed a higher response to GPVI agonists in STEMI patients compared to SCAD controls. In conclusion, we show an altered activation state of GPVI signaling in STEMI patients, confirming this receptor as a promising anti-thrombotic target for myocardial infarction.

Background: The mobilisation process of endothelial progenitor cells (EPC) after stent implantation by percutaneous coronary intervention (PCI) is unclear because the circulating EPC levels are influenced by several pathophysiological factors. The objective was to analyse the kinetics of EPC concentration following elective PCI in patients with stable angina, and its relation with other biomarkers or parameters of cardiovascular function., Methods: Pilot study in stable angina patients (n = 30) for elective PCI and implantation of bare-metal stent (BMS), drug-eluting stent (DES) or EPC-capturing stent (ECS). Samples were taken at baseline, 6 h, 24 h and 6 months after PCI for biochemical analysis and EPC quantification by flow cytometry., Results: Baseline EPC levels, quantified in peripheral blood, were related with the extent of the coronary lesion and the percentage of stenosis. EPC concentration increased 6 hours after PCI in relation with plasma C-reactive protein concentration and returned to basal levels after 24 hours post-PCI., Conclusions: Baseline EPC levels are related with the extension of the lesion and stenosis whereas the kinetics of EPC mobilization showed to be related with C-reactive protein concentration. Endothelial activation seems to occur in response to EPC mobilization or vascular damage by PCI.

Purpose: Platelets play a fundamental role in the atherothrombotic events that lead to an acute myocardial infarction. In the present study we compared the proteome of intracoronary and peripheral arterial platelets from ST-elevation myocardial infarction (STEMI) patients in the search for potential platelet biomarkers/drug targets related to what is happening at the culprit site., Experimental Design: Ten STEMI patients were recruited and blood collected from the occluded coronary artery, at the culprit site, in the moment of reperfusion. Systemic blood obtained from the radial artery of the same patients was used as control. Proteome analysis was based on high-resolution 2D-DIGE and mass spectrometry. Validations were by western blotting in a group of 11 patients., Results: Sixteen differentially regulated protein features were identified, corresponding to 15 ORFs, mostly related to cytoskeletal and signaling proteins. We demonstrate the up-regulation of integrin αIIb (ITA2B), the adapter Src kinase-associated phosphoprotein-2 (SKAP2), and thrombospondin-1 isoforms in intracoronary platelets., Conclusion and Clinical Relevance: This study constitutes the first analyzing in detail the proteome of arterial intracoronary platelets from STEMI patients. We show variations in the platelet proteome when comparing intracoronary and peripheral platelets. Observed differences might be related to platelet activation events at the culprit site., (© 2016 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.)

Objective: To evaluate immediate transcatheter aortic valve implantation (TAVI) results and medium-term follow-up in very elderly patients with severe and symptomatic aortic stenosis (AS)., Methods: This multicenter, observational and prospective study was carried out in three hospitals. We included consecutive very elderly (> 85 years) patients with severe AS treated by TAVI. The primary endpoint was to evaluate death rates from any cause at two years., Results: The study included 160 consecutive patients with a mean age of 87 ± 2.1 years (range from 85 to 94 years) and a mean logistic EuroSCORE of 18.8% ± 11.2% with 57 (35.6%) patients scoring ≥ 20%. Procedural success rate was 97.5%, with 25 (15.6%) patients experiencing acute complications with major bleeding (the most frequent). Global mortality rate during hospitalization was 8.8% (n = 14) and 30-day mortality rate was 10% (n = 16). Median follow up period was 252.24 ± 232.17 days. During the follow-up period, 28 (17.5%) patients died (17 of them due to cardiac causes). The estimated two year overall and cardiac survival rates using the Kaplan-Meier method were 71% and 86.4%, respectively. Cox proportional hazard regression showed that the variable EuroSCORE ≥ 20 was the unique variable associated with overall mortality., Conclusions: TAVI is safe and effective in a selected population of very elderly patients. Our findings support the adoption of this new procedure in this complex group of patients.

Rationale, Aims and Objectives: Transcatheter aortic valve implantation constitutes an example of a technology introduced into the Galician Health Care System basket and subjected to a post-introduction observational study after coverage. This paper aims to describe the process and results of this experience, illustrating the main challenges and opportunities in using these studies for supporting decision making., Methods: The study protocol was developed by a multidisciplinary team consisting of experts from the Galician HTA Agency (avalia-t), interventional cardiologists and cardiac surgeons. Together they agreed on the information that was relevant and feasible for collection, and planned the study design, data collection and analysis of results., Results: During the 1-year recruitment period, 94 patients underwent percutaneous aortic valve replacement in the three authorized centres. Implantation rate and prosthesis models differed substantially across the centres. Overall, procedural success rate was 96.8% and hospital mortality was 7.4%. Complications during post-surgical admission were recorded in 40.4% of patients. Moderate residual aortic regurgitation was observed in 10% of patients, and the procedure was associated with a stroke rate of 3.3% at 30 days and 5.3% at 1 year., Conclusions: Post-introduction observation has made it feasible to determine the use of this procedure within the SERGAS context and has enabled the assessment of performance in real-life conditions. The proposed strategic actions and interventions have been drawn up based upon the collective judgement of a group of experienced professionals, and have served to establish recommendations on further research that would be required to optimize health benefits., (© 2014 John Wiley & Sons, Ltd.)

Background: Transcatheter aortic valve implantation (TAVI) is the recommended therapy for patients with severe aortic stenosis who are not suitable candidates for surgery. The aim of this study was to describe early experience and long-term follow-up with the CoreValve self-expanding aortic prosthesis at 42 Ibero-American hospitals., Methods: Multiple centre observational study including 1220 consecutive patients with symptomatic severe aortic stenosis who are not suitable candidates for surgery and underwent transcatheter aortic valve implantation with the self-expanding Medtronic CoreValve System between December 2007 and May 2012., Results: The registry included 1220 consecutive patients with a mean age of 80.8 ± 6.3 years and a mean logistic euroSCORE of 17.8% ± 13%. The procedural success rate was 96.1%. Hospital mortality was 7.3% and combined end-point was 21.3%. Aortic regurgitation after TAVI was present in 24.5% (Sellers grade ≥ 2). The estimated 1-year and 2-year survival rates were 82.1% and 73.4% respectively. The following issues were significant independent risk factors for hospital mortality: acute kidney failure (odds ratio 3.55); stroke (odds ratio 5.72); major bleeding (odds ratio 2.64) and euroSCORE (odds ratio 1.02). Long-term predictors of mortality were diabetes mellitus (hazard ratio 1.59, 95% confidence interval 1.09-2.31), severe chronic obstructive pulmonary disease (hazard ratio 1.85, 95% confidence interval 1.85-2.88), and functional classes NYHA III-IV (hazard ratio 1.31, 95% confidence interval 1.01-1.70)., Conclusions: Transcatheter aortic valve implantation constitutes a safe and viable therapeutic option for high operative risk patients with severe aortic stenosis. Long-term prognosis is conditioned by associate comorbidities., (© 2013.)