Manuel Carrasco-Moraleja

Introduction and objectives: Acute heart failure (AHF) is the leading cardiovascular cause of hospitalization and remains associated with high mortality and rehospitalization rates. Contemporary real-world data from cardiology departments are scarce. We aimed to identify admission characteristics associated with one-year outcomes in patients hospitalized with AHF. Methods: RECYLICA is a prospective, multicentre, regional registry including consecutive patients admitted with AHF to cardiology departments across 10 hospitals over a one-year period. Patients were followed for 12 months. The primary endpoint was the composite of all-cause mortality or heart failure (HF) rehospitalization. Results: A total of 602 patients were included (37.0% women; mean age 72.6 ± 12.0 years), of whom 47.4% had heart failure with reduced left ventricular ejection fraction (HFrEF). During follow-up, 83 patients (13.8%) died and 105 (17.4%) were rehospitalized because of HF. Independent predictors of the primary endpoint were elevated admission N-terminal pro-B-type natriuretic peptide (NT-proBNP), atrial fibrillation (AF), chronic kidney disease (CKD), chronic obstructive pulmonary disease (COPD), previous HF, prior implantable cardioverter-defibrillator (ICD) implantation, and higher left ventricular ejection fraction (LVEF). Among patients with HFrEF, less comprehensive implementation of guideline-directed medical therapy (GDMT) at discharge was associated with significantly worse outcomes. Conclusions: In patients hospitalized with AHF, prognosis is primarily determined by comorbidity burden, admission NT-proBNP levels, previous HF, and LVEF. Among patients with HFrEF, more comprehensive implementation of GDMT at discharge was associated with improved clinical outcomes, supporting early optimization of evidence-based therapy during hospitalization.

Background: Recently, Acurate neo2 (ACN2; Boston Scientific, US) and Sapien‐3 series (Edwards Lifesciences, US) were compared in the IDE trial failing to demonstrate non‐inferiority of ACN2. The Myval series (MyV), an alternative balloon‐expandable device, demonstrated non‐inferiority compared to Sapien‐3 and Evolut (Medtronic, US) in the LANDMARK trial. However, no direct comparison exists between ACN2 and MyV. Aims: We aimed to compare mid‐term clinical and hemodynamic outcomes of the ACN2 and MyV transcatheter heart valves. Methods: This multicenter retrospective analysis included patients implanted with ACN2 and MyV series devices. The primary objective was to assess 1‐year mortality and stroke rates. Secondary outcomes included technical success, mortality, stroke, residual aortic regurgitation (AR), mean aortic gradients, and new permanent pacemaker implantation (PPI) rates up to 4 years. A matched comparison adjusting for clinical and anatomical characteristics was performed and echocardiograms were centrally analyzed. Results: A total of 545 patients (ACN2: 144; MyV: 401) from nine institutions were included. Matched technical success rates were 87.6% and 94.4%, p = 0.180 (90.3% for ACN2 and 97% for MyV; p < 0.001 in unmatched). In‐hospital matched PPI rates were 10.1% for ACN2 and 9% for MyV. At 4 years, matched residual ≥ moderate AR rates were similar (ACN2: 15.8% vs. MyV: 21.1%, p = 0.706), though ACN2 showed better mean aortic gradients (9.2 ± 4.2 vs. 13.1 ± 5.4, p = 0.001) and effective orifice area. Unmatched mortality + stroke rates were comparable but lower for ACN2 after matching (3.4% vs. 15.7%, p = 0.005). Importantly, cardiovascular mortality (3.4% for ACN2 and 5.6% for MyV, p = 0.720) and valve‐related deaths were comparable. Conclusion: ACN2 showed superior long‐term hemodynamics and lower matched 4‐year mortality and stroke rates, though cardiovascular mortality and valve‐related deaths were comparable.

Background: Patients receiving direct oral anticoagulation (DOAC) often require coronary angiography with or without percutaneous coronary intervention (PCI). Guidelines recommend DOAC withdrawal 12−24 h before the procedure based on experts' opinion. Therefore, the aim of this study was to assess the safety of an uninterrupted DOAC strategy during trans‐radial coronary procedures. Methods: prospective, single‐arm, pilot study conducted across six European centers. Enrolled patients underwent coronary angiography or PCI with intended transradial access without DOACs interruption. A safety stopping rule based on the occurrence of more than three Bleeding Academic Research Consortium (BARC) 3 or 5 bleeding events was prespecified. Primary outcome was BARC 2, 3, or 5 bleeding events at 30‐day follow‐up, which was compared against a prespecified objective performance criterion (OPC). The study is registered at ClinicalTrials.gov (NCT05292846). Results: A total of 200 patients were included. Median age was 75 years (IQR 69−80) and 29.0% were women. One in four (51, 25.5%) patients underwent PCI. At 30‐days, two BARC type 2 and two BARC type three bleeding events were reported. The uninterrupted DOAC strategy resulted in a rate of BARC types 2, 3, or 5 bleeding events of 2%, with the 1‐sided upper 95% confidence limit (4.5%) being lower than the OPC of 4.6% ( p = 0.045). Conclusions: DOAC‐NOSTOP is the first prospective study assessing the risk of periprocedural bleeding with uninterrupted DOAC in patients undergoing transradial coronary procedures. The uninterrupted DOAC strategy was shown to be safe and met the pre‐specified OPC, with low rates of clinically relevant or major bleeding at 30 days.

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: To evaluate analgesic practices in perioperative treatment during the SARS-CoV-2 pandemic; recording parameters collected in the PAIN OUT database, and to compare COVID and no-COVID data. Methods: Data were analyzed for 277 patients (87 COVID-19 confirmed diagnosis and 190 non-COVID): years aged, gender, minutes of surgery duration, Likert Scale punctuation, hours in severe pain, minimum and maximum pain intensity, interference with sleep quality, anxiety, need for help, nausea, drowsiness, itching, dizziness, perception of care, pain relief, participation, satisfaction, and information received. Results: Postoperative mortality 1 month after surgery was recorded at 25.3% in COVID-19. Significant differences were found in postoperative pain intensity (p = 0.019), time with severe pain (p < 0.01), lower sleep quality (p < 0.01), and better outcomes in functional items (p < 0.01); there were more side effects and satisfaction with pain relief (p < 0.01) in COVID-patients than with no COVID-19 patients. Conclusions: In conclusion, COVID-19 patients presented greater intensity and duration of severe postoperative pain, greater somnolence, pruritus, and dizziness, lower physical activity limitation, and higher quality index.

To evaluate analgesic practices in perioperative treatment during SARS-CoV-2 pandemic; recording parameters collected in the PAIN OUT database, and to compare COVID and no-Covid data. Data were analyzed for 277 patients (87 with COVID-19 confirmed diagnosis): 67.55 +/- 15.714 years aged; predominance of male gender (54.02%), 200.67+/118.582 minutes of surgery, Likert Scale punctuation 1.55+/-1.461; 4.63+/-3.233 hours in severe pain; minimum pain intensity of 1.11+/-1.582 and maximum of 5.68+/-2.166; interference with sleep quality 4.45 +/-2.867; 0-10); anxiety of 4.83 +/-3.175; need for help 3.83 +/-3.100; nausea 1.75 +/- 2.469; drowsiness of 3.70+/-2.694; itching of 2.80+/-2.102; dizziness of 3.78+/-2.347; perception of care of 51.75+/-28.315; pain relief of 6.65+/-2.477, participation of 7.27+/-2.892; satisfaction of 79.84 +/-17.459, and information received of 81.75 +/-17.647. Postoperative mortality one month after surgery was recorded at 25.3% in COVID-19. Significant differences were found in postoperative pain intensity (p=0.019), time with severe pain (p<0.01), lower sleep quality (p0.01), more side effects and satisfaction with pain relief (p<0.01) in Covid-patients than no COVID-19 patients. In conclusion, COVID-19 patients presented. greater intensity and duration of severe postoperative pain, greater somnolence, pruritus, and dizziness, lower physical activity limitation, and higher quality index.

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

There are known pathophysiologic and clinical differences according to sex in patients with aortic stenosis (AS). To evaluate if these differences persist after valve replacement, we conducted an observational study including 451 patients with symptomatic AS who survived aortic valve intervention (AVI) in two centers. Clinical data and mortality were evaluated at a mean follow-up of 5 years. 56% of patients were women. At baseline, women were older (80.6 vs. 78 years, p = 0.013), presented higher mean gradient (48 vs. 45 mmHg, p = 0.023), lower aortic valve area (0.70 vs. 0.74 cm², p = 0.002) and higher systolic pulmonary artery pressure (36 vs. 33 mmHg, p = 0.016). They underwent percutaneous aortic valve replacement more frequently than men (47 vs. 35.9%, p = 0.017). At 5 years follow-up, women required more admissions due to heart failure (23 vs. 9%, p = 0.046) but they did not present higher cardiovascular nor overall mortality (27.7% vs. 29.8%, p = 0.741; 11.1 vs. 10.1%, p = 0.619, respectively). Female sex was an independent predictor of heart failure hospitalization at follow-up (HR 95% 1.16–4.22, p = 0.016). Women undergo AVI at a more advanced stage than men, resulting in a higher frequency of readmissions due to heart failure during the follow-up period, but not in higher mortality.

Recent works have demonstrated a significant reduction in cholesterol levels and increased oxidative stress in patients with coronavirus disease 2019 (COVID-19). The cause of this alteration is not well known. This study aimed to comprehensively evaluate their possible association during the evolution of COVID-19. This is an observational prospective study. The primary endpoint was to analyze the association between lipid peroxidation, lipid, and inflammatory profiles in COVID-19 patients. A multivariate regression analysis was employed. The secondary endpoint included the long-term follow-up of lipid profiles. COVID-19 patients presented significantly lower values in their lipid profile (total, low, and high-density lipoprotein cholesterol) with greater oxidative stress and inflammatory response compared to the healthy controls. Lipid peroxidation was the unique oxidative parameter with a significant association with the total cholesterol (OR: 0.982; 95% CI: 0.969–0.996; p = 0.012), IL1-RA (OR: 0.999; 95% CI: 0.998–0.999; p = 0.021) IL-6 (OR: 1.062; 95% CI: 1.017–1.110; p = 0.007), IL-7 (OR: 0.653; 95% CI: 0.433–0.986; p = 0.042) and IL-17 (OR: 1.098; 95% CI: 1.010–1.193; p = 0.028). Lipid abnormalities recovered after the initial insult during long-term follow-up (IQR 514 days); however, those with high LPO levels at hospital admission had, during long-term follow-up, an atherogenic lipid profile. Our study suggests that oxidative stress in COVID-19 is associated with derangements of the lipid profile and inflammation. Survivors experienced a recovery in their lipid profiles during long-term follow-up, but those with stronger oxidative responses had an atherogenic lipid profile.

Background (1): Headache is a prevalent symptom experienced during ongoing SARS-CoV-2 infection, but also weeks after recovery. Whether cardio-pulmonary dysfunction contributes causally to headache persistence is unknown. Methods (2): We conducted a case-control analysis nested in a prospective cohort study. Individuals were recruited from August 2020 to December 2020. Patients were grouped according to the presence or absence of long-COVID headache for three months after COVID-19 resolution. We compared demographic data, clinical variables, cardio-pulmonary laboratory biomarkers, quality of life, and cardio-pulmonary function between groups. Results (3): A cohort of 70 COVID-19 patients was evaluated. Patients with headaches (n = 10; 14.3%) were more frequently female (100% vs. 58.4%; p = 0.011) and younger (46.9 ± 8.45 vs. 56.13 ± 12 years; p = 0.023). No between-group differences in laboratory analysis, resting echocardiography, cardio-pulmonary exercise test, or pulmonary function tests were observed. Conclusion (4): In this exploratory study, no significant differences in cardio-pulmonary dysfunction were observed between patients with and without long-COVID headache during mid-term follow-up.