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Introduction and Objectives: Impact of gender on long-term outcomes after transcatheter aortic valve implantation (TAVI) remains uncertain. We aimed to investigate gender-specific differences in TAVI and its impact on outcomes., Methods: This analysis used data from the prospective Spanish TAVI registry, which included consecutive TAVI patients treated in 46 Spanish centers from 2009 to 2021. The primary endpoint was all-cause mortality at 12 months. Secondary endpoints included in-hospital and 30-day mortality and TAVI-related complications. Adjusted logistic and Cox regression analyses were performed., Results: The study included 12 253 consecutive TAVI patients with a mean age of 81.2±6.4 years. Women (53.9%) were older, and had a higher STS-PROM score (7.0±7.0 vs 6.2±6.7; P < .001) than men. Overall, the TAVI-related complication rate was similar between women and men, with specific gender-related complications. While women more frequently developed in-hospital vascular complications (13.6% vs 9.8%; P <.001) and cardiac tamponade (1.5% vs 0.6%; P=.009), men showed a higher incidence of permanent pacemaker implantation (14.5% vs 17.4%; P=.009). There was no difference in all-cause mortality either in hospital (3.6% vs 3.6%, adjusted OR, 1.01; 95%CI, 0.83-1.23; P=.902), at 30 days (4.2% vs 4.2%, adjusted OR, 0.90; 95%CI, 0.65-1.25; P=.564) or at 1 year (11% vs 13%, adjusted HR, 0.94; 95%CI, 0.80-1.11; P=.60)., Conclusions: Women treated with TAVI are older and have more comorbidities than men, leading to distinct complications between genders. Nevertheless, all-cause mortality in the short-term and at 1-year was similar between men and women., (Copyright © 2024 Sociedad Española de Cardiología. Published by Elsevier España, S.L.U. All rights reserved.)

Background: Coronary obstruction (CO) following transcatheter aortic valve replacement (TAVR) is a life-threatening complication, scarcely studied., Objectives: The authors analyzed the incidence of CO after TAVR, presentation, management, and in-hospital and 1-year clinical outcomes in a large series of patients undergoing TAVR., Methods: Patients from the Spanish TAVI (Transcatheter Aortic Valve Implantation) registry who presented with CO in the procedure, during hospitalization or at follow-up were included. Computed tomography (CT) risk factors were assessed. In-hospital, 30-day, and 1-year all-cause mortality rates were analyzed and compared with patients without CO using logistic regression models in the overall cohort and in a propensity score-matched cohort., Results: Of 13,675 patients undergoing TAVR, 115 (0.80%) presented with a CO, mainly during the procedure (83.5%). The incidence of CO was stable throughout the study period (2009-2021), with a median annual rate of 0.8% (range 0.3%-1.3%). Preimplantation CT scans were available in 105 patients (91.3%). A combination of at least 2 CT-based risk factors was less frequent in native than in valve-in-valve patients (31.7% vs 78.3%; P < 0.01). Percutaneous coronary intervention was the treatment of choice in 100 patients (86.9%), with a technical success of 78.0%. In-hospital, 30-day, and 1-year mortality rates were higher in CO patients than in those without CO (37.4% vs 4.1%, 38.3% vs 4.3%, and 39.1% vs 9.1%, respectively; P < 0.001)., Conclusions: In this large, nationwide TAVR registry, CO was a rare, but often fatal, complication that did not decrease over time. The lack of identifiable predisposing factors in a subset of patients and the frequently challenging treatment when established may partly explain these findings., Competing Interests: Funding Support and Author Disclosures The Spanish TAVI registry is managed and maintained with funding from the Interventional Cardiology Association of the Spanish Cardiology Society. Dr Ojeda has received consulting fees from Medtronic and Edwards Lifesciences; has received speaker fees from Philips and World Medical; and holds a research grant (PI21/00949) from the Spanish Ministry of Science and Innovation (Instituto de Salud Carlos III). Dr Asmarats is proctor for Abbott Vascular; and has received speaker fees from Edwards Lifesciences. Dr Amat-Santos is a proctor for Medtronic, Boston Scientific, and Meril Life. Dr Romaguera is proctor for Biosensor. Dr Moreno is a proctor for Boston Scientific and Biosensor. Dr Pan has received speaker fees from Abbott, Boston Scientific, World Medical, and Philips; and holds a research grant (PI21/00949) from the Spanish Ministry of Science and Innovation (Instituto de Salud Carlos III). All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Purpose: The objective of this study was to assess the concordance between the values obtained in measuring central corneal thickness using the OrbscanIIz ® and the contact ultrasonic pachymeter available in our public ophthalmology service., Methods: Measurements were taken from 88 eyes of 44 patients using the two instruments. The data obtained were statistically analyzed using version 22 of the IBM SPSS ® program., Results: The mean of central corneal thickness measurements obtained from OrbscanIIz ® was significantly higher than that obtained from ultrasound pachymetry. However, the mean of differences between both instruments was only 7.22 μ, which could be considered a clinically insignificant result when considering the good concordance obtained between both systems., Conclusion: OrbscanIIz ® and ultrasound pachymetry can be interchangeable in the usual public clinical practice when measuring central corneal thickness. This is the first research found in the literature that uses a concordance study to compare the data resulting from central corneal thickness measurements obtained by an OrbscanIIz ® and an OcuScan ® pachymeter in our environment., Competing Interests: There are no conflicts of interest., (Copyright: © 2023 Saudi Journal of Ophthalmology.)

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: Coronary artery disease (CAD) detection in asymptomatic patients still remains controversial. The aim of our study was to evaluate the usefulness of ophthalmologic findings as predictors of the presence of CAD when added to cardiovascular classic risk factors (CRF) in patients with acute coronary cardiopathy suspicion., Methods: After clinical stabilization, 96 patients with acute coronary cardiopathy suspicion were selected and divided in two groups: 69 patients with coronary lesions and 27 patients without coronary lesions. Their 192 eyes were subjected to a complete routine ophthalmologic examination. Samples of tear fluid were also collected to be used in the detection of cytokines and inflammatory mediators. Logistic regression models, receiver operating characteristic curves and their area under the curve (AUC) were analysed., Results: Suggestive predictors were choroidal thickness (CT) (OR: 1.02, 95% CI 1.01-1.03) and tear granulocyte colony-stimulating factor (G-CSF) (OR: 0.97, 95% CI 0.95-0.99). We obtained an AUC of 0.9646 (95% CI 0.928-0.999) when CT and tear G-CSF were added as independent variables to the logistic regression model with cardiovascular CRF: sex, age, diabetes, high blood pressure, hypercholesterolemia, smoking habit and obesity. This AUC was significantly higher (p = 0.003) than the prediction derived from the same logistic regression model without CT and tear G-CSF (AUC = 0.828, 95% CI 0.729-0.927)., Conclusions: CT and tear G-CSF improved the predictive model for CAD when added to cardiovascular CRF in our sample of symptomatic patients. Subsequent studies are needed for validation of these findings in asymptomatic patients., (© 2022. The Author(s).)

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., (Copyright © 2021 Sociedad Española de Cardiología. Published by Elsevier España, S.L.U. All rights reserved.)

Background: Vascular and bleeding complications related to secondary femoral access site are frequent in patients undergoing transcatheter aortic valve replacement (TAVR), and their occurrence is associated to poorer outcomes. We aimed to evaluate the clinical impact of vascular closure devices (VCDs) for secondary femoral access hemostasis in TAVR procedures., Methods: This was a multicenter study including 4031 patients who underwent TAVR (mean age, 81 ± 8 years; mean Society of Thoracic Surgeons [STS] score, 4.9 [interquartile range, 3.3-7.6]), and had a secondary femoral access. The 30-day clinical outcomes were analyzed according to femoral access-site hemostasis (manual compression vs VCD), and according to the type of VCD (Perclose [Abbott Cardiovascular] vs Angio-Seal [Terumo Interventional Systems]) using a propensity-matched, multivariable, logistic regression model., Results: Manual compression was used in 941 patients (23.3%) and VCDs were used in 3090 patients (76.7%; Perclose in 1549 patients [38.4%] and Angio-Seal in 1541 patients [38.2%]) for secondary femoral access hemostasis. Vascular complications related to secondary access site occurred in 162 patients (4%), and were more frequent in patients who underwent manual compression (7.2%) compared with VCD hemostasis (3%; adjusted P<.001). In the VCD group, the use of Angio-Seal (vs Perclose) was associated with a higher rate of vascular complications (3.7% vs 2.4%, respectively; adjusted P=.02), femoral artery pseudoaneurysm (1.3% vs 0.4%, respectively; adjusted P<.01), invasive treatment requirement for treating vascular complications (surgery: 0.8% vs 0.3%, respectively [adjusted P=.03]; and thrombin injection: 0.9% vs 0%, respectively [adjusted P<.001])., Conclusion: VCDs represented a safer and more effective alternative compared with manual compression for secondary femoral access-site hemostasis in patients undergoing TAVR procedures, and the Perclose VCD was associated with the lowest risk of vascular complications. Future randomized studies are warranted.

Objectives: To determine the occurrence of vascular complications (VCs) following transfemoral transcatheter aortic valve replacement (TAVR) with new-generation devices according to the use of a crossover technique (COT)., Background: The use of a COT (with/without balloon) has been associated with a reduction of VCs in TAVR patients. However, scarce data support its use with second-generation devices. Also, its potential benefit in obese patients (at high-risk of VCs) has not been elucidated., Methods: A multicenter study including 2214 patients who underwent full percutaneous transfemoral TAVR (COT, 1522 patients; no COT, 692 patients). Thirty-day events were evaluated according to the use of a COT using a multivariate logistic regression model. A subanalysis was performed in obese patients., Results: Primary access major VCs (3.5% COT vs 3.9% no COT; P=.19), major/life-threatening bleeding (3.4% COT vs 2.0% no COT; P=.33), and mortality rates (2.4% COT vs 2.6% no COT; P=.23) were similar between groups. However, minor VCs (11.7% COT vs 5.9% no COT; P<.001) and postprocedural acute renal failure (8.9% COT vs 3.9% no COT; P<.001) were higher in patients undergoing the COT. In the overall cohort, percutaneous closure device failure was more frequent in obese patients (4.0% in the obese group vs 1.9% in the non-obese group; P<.01), but these differences were no longer significant in those undergoing a COT (3.4% in the obese group vs 2.0% in the non-obese group; P=.12). Indeed, in the subset of obese patients, the COT tended to be associated with fewer VCs (3.4% COT vs 5.9% no COT; P=.09)., Conclusions: The use of a COT was not associated with a reduction of major VCs or improved outcomes. However, some patient subsets, such as those with higher body mass index, may benefit from the use of a COT. These findings would suggest the application of a tailored strategy, following a risk-benefit assessment in each TAVR candidate.

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.)

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 <0.001; major VC, 1.6% versus 0%, P <0.001). In the propensity score-matched population, VC related to the secondary access remained higher in the transfemoral group (4.7% versus 0.9%, P <0.001; major VC, 1.8% versus 0%, P <0.001), which also exhibited a higher rate of major/life-threatening bleeding events (1.0% versus 0%, P <0.001). Significant differences between secondary access groups were observed regarding the rates of 30-day stroke (transfemoral: 3.1%, transradial: 1.6%; P =0.043), acute kidney injury (transfemoral: 9.9%, transradial: 5.7%; P <0.001), and mortality (transfemoral: 4.0%, transradial: 2.4%, 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.

Background: Acute kidney injury (AKI) after cardiac surgery is associated with increased mortality, but few data exist on the occurrence and clinical impact of AKI associated with transcatheter aortic valve implantation (TAVI). The objective of this study was to determine the incidence and prognosis of AKI after percutaneous implantation of the CoreValve(®) (Medtronic, Minneapolis, MN, USA) prosthesis., Methods: A total of 357 patients with severe aortic stenosis and 9 patients with pure native aortic regurgitation were treated with the CoreValve prosthesis. AKI was defined according to Valve Academic Research Consortium criteria as the absolute increase in serum creatinine ≥0.3mg/dl at 72h post percutaneous procedure., Results: AKI was identified in 58 patients (15.8%), none of whom required renal replacement therapy. In patients with AKI, the mortality at 30 days was 13.5% compared with 1.6% of patients without AKI, [odds ratio (OR)=12.2 (95% CI 3.53-41.9); p<0.001] and total mortality after a mean of 26.2±17 months was 29.3% vs. 14.9% [OR=2.36 (95% CI 1.23-4.51), p=0.008]. In the multivariate analysis, AKI was an independent predictor of cumulative total mortality [hazard ratio=2.151, (95% CI from 1.169 to 3.957), p=0.014]., Conclusions: The deterioration of renal function in patients undergoing TAVI with the CoreValve prosthesis is a serious and frequent complication. The occurrence of AKI was associated with increased early mortality and was also a predictor of worse outcomes in follow-up., (Copyright © 2014 Japanese College of Cardiology. Published by Elsevier Ltd. All rights reserved.)

Scope: Today, about 2-8% of the population of Western countries exhibits some type of food allergy whose impact ranges from localized symptoms confined to the oral mucosa to severe anaphylactic reactions. Consumed worldwide, lettuce is a Compositae family vegetable that can elicit allergic reactions. To date, however, only one lipid transfer protein has been described in allergic reaction to lettuce. The aim of this study was to identify potential new allergens involved in lettuce allergy., Methods and Results: Sera from 42 Spanish lettuce-allergic patients were obtained from patients recruited at the outpatient clinic. IgE-binding proteins were detected by SDS-PAGE and immunoblotting. Molecular characterization of IgE-binding bands was performed by MS. Thaumatin was purified using the Agilent 3100 OFFGEL system. The IgE-binding bands recognized in the sera of more than 50% of patients were identified as lipid transfer protein (9 kDa), a thaumatin-like protein (26 kDa), and an aspartyl protease (35 and 45 kDa). ELISA inhibition studies were performed to confirm the IgE reactivity of the purified allergen., Conclusion: Two new major lettuce allergens-a thaumatin-like protein and an aspartyl protease-have been identified and characterized. These allergens may be used to improve both diagnosis and treatment of lettuce-allergic patients., (© 2013 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.)