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Introduction and Objectives: The optimal chronic antithrombotic regimen for patients with atrial fibrillation undergoing transcatheter aortic valve implantation (TAVI) remains uncertain. Our aim was to compare the incidence of late bleeding events between patients on direct oral anticoagulants (DOACs) and those on vitamin-K antagonists (VKA)., Methods: This single-center observational study included TAVI patients requiring oral anticoagulation at discharge between 2015 and 2021. The primary endpoint was any clinically significant bleeding event. Secondary endpoints were stroke, heart failure, and all-cause mortality., Results: A total of 702 TAVI procedures were performed, with 297 patients requiring oral anticoagulation at discharge. Among them, 206 (69.4%) received VKA and 91 (30.6%) received DOAC. Baseline clinical, procedural and in-hospital characteristics did not significantly differ between groups, except for better renal function among DOAC patients. The median length of follow-up was 2.8 years. The risk of bleeding events was higher in patients receiving DOACs than in those receiving VKA (HR, 2.27; 95%CI, 1.21-4.26; incidence of 9.7 and 4.2 events per 100 patient-years of follow-up for DOAC and VKA patients, respectively). There were no statistically significant differences in the rates of stroke (HR, 1.28; 95%CI, 0.4-4.3), heart failure hospitalization (HR, 0.92; 95%CI, 0.46-1.86), or all-cause mortality (HR, 1.02; 95%CI, 0.68-1.55)., Conclusions: In older patients undergoing TAVI and receiving anticoagulant therapy for atrial fibrillation, the use of DOAC was associated with a higher risk of late bleeding events than VKA., (Copyright © 2024 Sociedad Española de Cardiología. Published by Elsevier España, S.L.U. All rights reserved.)

Objectives: The impact of functional capacity over the entire functional continuum in older adults undergoing aortic valve replacement (AVR) has not been studied to date. This study aims to analyze 1.- the distribution of a cohort of older adults presenting severe aortic stenosis (AS) amenable to AVR in the different categories of the Functional Continuum Scale (FCS); 2.- its association with decision-making regarding valve disease; and 3.- its impact upon the one-year mortality rate of surgical (SAVR), transcatheter (TAVR) aortic valve replacement, or the decision to provide conservative management (OMT)., Methods: This prospective study included patients from the FRESAS (FRailty-Evaluation-in-Severe-Aortic-Stenosis) registry evaluated by the reference Heart-Team of a region in northern Spain. All the patients underwent comprehensive geriatric assessment., Results: The study comprised 257 patients aged 84.0 ± 3.9 years., Management: SAVR: 25.3%, TAVR: 58.0% and OMT: 16.7%. Increased patient functional capacity was associated with an increased tendency to perform more invasive valve disease treatment. The overall one-year survival rate was 81.3%. One-year all-cause mortality: FCS-1 to FCS-2 "robust" 11.5%, FCS-3 to FCS-4 "prefrail" 14.7%, FCS-5 "frail" 19.2% and FCS-6 to FCS-8 "dependent" 45.0%; p < 0.001. Adjusted mortality analysis: FCS with HR = 1.206 [95%CI, 0.999-1.451 (p = 0.051)]; EuroSCORE-II with HR = 1.071 [95%CI, 1.006-1.161 (p = 0.033)]; and OMT with HR = 2.840 [95%CI, 1.409-5.772 (p = 0.004)] were retained in the final multivariable logistic regression model., Conclusions: In older AS patients amenable to AVR, the FCS is a useful predictive tool that may aid clinical decision-making., (© 2022. The Author(s), under exclusive licence to Springer Nature Switzerland AG.)

Introduction and Objectives: This study aimed to determine the safety and efficacy of modifying the classic implantation technique for aortic transcatheter heart valve (THV) implantation to a cusp-overlap-projection (COP) technique to achieve a higher implantation depth and to reduce the burden of new permanent pacemaker implantation (PPMI) at 30 days. Aortic self-expanding THV carries an elevated risk for PPMI. A higher implantation depth minimizes the damage in the conduction system and may reduce PPMI rates., Methods: From March 2017, 226 patients were consecutively included: 113 patients were treated using the COP implantation technique compared with the previous 113 consecutive patients treated using the classic technique. In all patients, implantation depth was assessed by 3 methods (noncoronary cusp to the THV, mean of the noncoronary cusp and the left coronary cusp to the THV, and the deepest edge from the left coronary cusp and the noncoronary cusp to the THV)., Results: The COP group had a lower implantation depth than the group treated with the classic technique (4.8 mm± 2.2 vs 5.7 mm± 3.1; P=.011; 5.8 mm± 3.1 vs 6.5 mm± 2.4; P=.095; 7.1 mm± 2.8 vs 7.4 mm±3.2; P=.392). Forty patients (17.7%) required a new PPMI after the 30-day follow-up but this requirement was significantly lower in the COP group (12.4% vs 23%, P=.036). The COP implantation technique consistently protected against the main event (OR, 0.45; 95%CI, 0.21-0.97; P=.043), with similar procedural success rates and complications., Conclusions: The COP implantation technique is a simple modification of the implantation protocol and provides a higher implantation depth of self-expanding-THV with lower conduction disturbances and PPMI rates., (Copyright © 2021 Sociedad Española de Cardiología. Published by Elsevier España, S.L.U. All rights reserved.)

Background: The aim of this study was to assess the safety and effectiveness of valve in valve (VIV) TAVI with the autoexpandable valve, specifically in patients with failed Mitroflow (MF) bioprosthetic aortic valves., Methods: Pilot, single center, observational and prospective study that included 45 consecutive patients with symptomatic failed MF bioprosthetic aortic valve, referred for VIV TAVI. The safety primary endpoint was a composite of early events at 30 days, defined by VARC-2 criteria. The efficacy primary endpoint was the device success (no procedural mortality, correct positioning of a single prosthetic heart valve into the proper anatomical location and absence of moderate/severe prosthetic aortic valve regurgitation). We also analysed patient-prosthesis mismatch (PPM) parameters., Results: Between March 2012 to December 2017, 45 symptomatic patients (age 79.9 ± 6.5 years) with degenerated MF valves (numbers 19: 33.3%; 21: 28.9%; 23: 24.4%; 25: 13.3%) underwent CoreValve (n = 11) or Evolut R (n = 34) implantation (23 and 26 mm sizes). The STS predicted risk of mortality was 6.3 ± 6.3%. The safety primary endpoint occurred in 4 patients (8.8%). The efficacy endpoint was present in all patients (100%). There were no coronary occlusions or procedural deaths. The number of patients with any degree of PPM raised from 51.1% (pre-TAVI) to 60% (post-TAVI)., Conclusions: Self-expanding TAVI for degenerated MF bioprosthesis has favourable early outcomes. The VIV procedure has provided an important gateway to avoiding high-risk redo surgery and is now a potential option for MF failed surgically aortic implanted valves., (Copyright © 2019 Elsevier B.V. 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.)

Objectives: This study sought to assess the influence of baseline right bundle branch block (RBBB) on all-cause and cardiovascular mortality as well as sudden cardiac death (SCD) among patients undergoing transcatheter aortic valve replacement (TAVR)., Background: Few data exist regarding the late clinical impact of pre-existing RBBB in TAVR recipients., Methods: A total of 3,527 patients (mean age 82 ± 8 years, 50.1% men) were evaluated according to the presence of RBBB on baseline electrocardiography. Intraventricular conduction abnormalities were classified according to the American Heart Association, American College of Cardiology Foundation, and Heart Rhythm Society recommendations for standardization and interpretation of the electrocardiogram. TAVR complications and causes of death were defined according to Valve Academic Research Consortium 2 definitions., Results: RBBB was present on baseline electrocardiography in 362 patients (10.3%) and associated with higher 30-day rates of permanent pacemaker implantation (PPI) (40.1% vs. 13.5%; p < 0.001) and death (10.2% vs. 6.9%; p = 0.024). At a mean follow-up of 20 ± 18 months, pre-existing RBBB was independently associated with all-cause mortality (hazard ratio [HR]: 1.31; 95% confidence interval [CI]: 1.06 to 1.63; p = 0.014) and cardiovascular mortality (HR: 1.45; 95% CI: 1.11 to 1.89; p = 0.006) but not with SCD (HR: 0.71; 95% CI: 0.22 to 2.32; p = 0.57). Patients with pre-existing RBBB and without PPI at discharge from the index hospitalization had the highest 2-year risk for cardiovascular death (27.8%; 95% CI: 20.9% to 36.1%; log-rank p = 0.007). In a subanalysis of 1,245 patients without PPI at discharge from the index hospitalization and with complete follow-up regarding the need for PPI, pre-existing RBBB was independently associated with the composite of SCD and PPI (HR: 2.68; 95% CI: 1.16 to 6.17; p = 0.023)., Conclusions: Pre-existing RBBB was found in 10% of TAVR recipients and was associated with poorer clinical outcomes. Patients with baseline RBBB without permanent pacemakers at hospital discharge may be at especially high risk for high-degree atrioventricular block and/or SCD during follow-up. Future studies should evaluate strategies aimed at the early detection of patients at risk for late development of high-degree atrioventricular block., (Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. 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.)

Introduction and Objectives: Transcatheter aortic valve implantation (TAVI) is a safe and effective alternative to surgical treatment in patients with severe aortic stenosis (AS) and those who are inoperable or at high surgical risk. The primary objective of this study was to evaluate the long-term survival of consecutive patients with severe AS treated with TAVI., Methods: Observational, multicenter, prospective, follow-up study of consecutive patients with severe symptomatic AS treated by TAVI in 3 high-volume hospitals in Spain., Results: We recruited 108 patients, treated with a self-expanding CoreValve prosthesis. The mean age at implantation was 78.6 ± 6.7 years, 49 (45.4%) were male and the mean logistic EuroSCORE was 16% ± 13.9%. The median follow-up was 6.1 years (2232 days). Survival rates at the end of years 1, 2, 3, 4, 5, and 6 were 84.3% (92.6% after hospitalization), 77.8%, 72.2%, 66.7%, 58.3%, and 52.8%. During follow-up, 71 patients (65.7%) died, 18 (25.3%) due to cardiac causes. Most (82.5%) survivors were in New York Heart Association class I or II. Six patients (5.5%) developed prosthetic valve dysfunction., Conclusions: Long-term survival in AS patients after TAVI is acceptable. The main causes of death are cardiovascular in the first year and noncardiac causes in subsequent years. Valve function is maintained over time., (Copyright © 2016 Sociedad Española de Cardiología. Published by Elsevier España, S.L.U. All rights reserved.)

Background and Aim: The clinical impact of patient-prosthesis mismatch (PPM) on outcomes in young and middle-aged patients undergoing surgery for aortic valve replacement (AVR) remains unknown. Our objective was to examine the mid-term impact of PPM on overall mortality, quality of life, and cardiac events in this population., Methods: All patients younger than 70 years of age undergoing isolated AVR from October 2005 to October 2011 were analyzed. PPM was defined as the indexed effective orifice area ≤ 0.85 cm(2) /m(2) . We studied the impact of PPM on mid-term overall mortality, cardiac events, and New York Heart Association functional class using an analysis stratified for propensity score. Cardiac events were defined as cardiac death, sudden death, hospital readmission due to angina, syncope or heart failure or reoperation on aortic prosthesis., Results: Two hundred and ninety-three patients were included in the study, of whom 81 (27.61%) had some degree of PPM. PPM had no impact on mid-term overall mortality (HR=1.45; 95% CI=0.65-3.22; p=0.36), although it had a negative impact on cardiac events (HR=11.52; 95% CI=5.25-25.24; p<0.001) and functional class (RR=7.55; 95% CI=2.59-22.03; p<0.001)., Conclusions: Moderate PPM appears to be a strong and independent predictor of cardiac events and advanced functional class in young and middle-aged patients undergoing AVR for severe stenosis. However, it is possible that it has no impact on overall mortality., (© 2013 Wiley Periodicals, Inc.)

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.)

Introduction and Objectives: There is little information on the use of transcatheter aortic valve implantation in patients with severe aortic stenosis and porcelain aorta. The primary aim of this study was to analyze death from any cause after CoreValve(®) implantation in patients with severe aortic stenosis, with and without porcelain aorta., Methods: In this multicenter, observational prospective study, carried out in 3 hospitals, percutaneous aortic valves were implanted in 449 patients with severely calcified aortic stenosis. Of these, 36 (8%) met the criteria for porcelain aorta. The primary end-point was death from any cause at 2 years., Results: Patients with porcelain aorta more frequently had extracardiac vascular disease (11 [30.6%] vs 49 [11.9%]; P=.002), prior coronary revascularization (15 [41.7%] vs 98 [23.7%]; P=.017), and dyslipidemia (26 [72.2%] vs 186 [45%]; P=.02). In these patients, there was greater use of general anesthesia (15 [41.7%] vs 111 [16.9%]; P=.058) and axillary access (9 [25%] vs 34 [8.2%]; P=.004). The success rate of the procedure (94.4 vs 97.3%; P=.28) and the incidence of complications (7 [19.4%] vs 48 [11.6%]; P=.20) were similar in both groups. There were no statistically significant differences in the primary end point at 24 months of follow-up (8 [22.2%] vs 66 [16%]; P=.33). The only predictive variable for the primary end point was the presence of complications during implantation (hazard ratio=2.6; 95% confidence interval, 1.5-4.5; P=.001)., Conclusions: In patients with aortic stenosis and porcelain aorta unsuitable for surgery, percutaneous implantation of the CoreValve(®) self-expanding valve prosthesis is safe and feasible., (Copyright © 2013 Sociedad Española de Cardiología. Published by Elsevier Espana. All rights reserved.)

Background: Transcatheter aortic valve implantation (TAVI) is taking a leading role in the management of patients with severe aortic stenosis. Valve replacement surgery prolongs survival and is the technique of choice considering its historical background and long experience worldwide. Recently however, TAVI has positioned itself as the only standard therapy for symptomatic patients who are not candidates for surgery., Aim: To report the experience with this new technique comparing our results with those reported in the literature., Material and Methods: Between May 2010 and December 2011,17 patients aged 81 ± 7.3 years (58.8% men with an Euro SCORE 29 ± 22.4%) underwent a TAVI., Results: The median transvalvular gradient was 54 ± 15.7 mmHg. All patients received a CoreValve™. Technical success was 100%, with a post implant gradient of 6.29 ± 3.3 mmHg. Residual aortic regurgitation was observed in 94%, none greater than grade II. There were no complications at the vascular access site. One patient developed cardiac tamponade during the procedure. Permanent pacemaker implantation was required in 35.2%. Hospital mortality rate was 5.8%, a figure that remained unchanged at 30 days of follow-up., Conclusions: In high-risk patients with aortic stenosis, TAVI has a high success rate and a low rate of complications. Besides an appropriate patient selection, a trained multidisciplinary team and technical conditions to solve possible complications of the procedure are required.

Introduction and Objectives: To validate the axillary approach as a safe and efficient option for the transcatheter aortic valve implantation in patients who have contraindication for femoral approach at three Spanish hospitals., Methods: We included patients with severe symptomatic aortic stenosis at very high or prohibitive surgical risk, selected by a multidisciplinary team, for transcatheter aortic valve implantation, and had contraindication to the femoral approach., Results: We included 19 of 186 (10.5%) patients, who were implanted a percutaneous aortic valve, between November 2008 and March 2010. The mean age was 78.3 (standard deviation [SD]±8.65) years and 73.7% were males. The mean logistic EuroSCORE was 28.7% (SD±16.3%). The procedural success rate was 100%. After the procedure the maximum transvalve gradient decreased from 81.7 mmHg (SD±21.5) to 15.8 mmHg (SD±5.5), and no patient presented residual aortic regurgitation >2. The all-cause mortality, with a mean follow-up time of 9.2 (SD±3.2) months was 10.5%, and the in-hospital and 30-day mortality rates were 0%. The global incidence of major complications due to the procedure was 15.7%. Definitive pacemaker implantation was carried out for atrioventricular block in 8 patients (44.4%)., Conclusions: The axillary approach for transcatheter aortic valve implantation using the CoreValve(®) and contraindication to the femoral approach is safe and efficient for selected patients, with excellent results in terms of success implantation and in hospital and 30-day mortality., (Copyright © 2010 Sociedad Española de Cardiología. Published by Elsevier Espana. All rights reserved.)

Introduction and Objectives: Greater life-expectancy has led to an increase in the incidence of severe aortic stenosis, which accounts for a significant proportion of the workload of cardiology departments. With the imminent arrival of percutaneous aortic valve prostheses, it is important to know how effective surgery currently is in octogenarians., Methods: The study included all patients aged >or=80 years with severe aortic stenosis who underwent cardiac catheterization prior to aortic valve replacement between May 1996 and May 2006. The percentage of patients who underwent surgery, outcomes at 30 days, long-term survival, and predictors of mortality were analyzed., Results: Of the 137 patients evaluated, 104 (75.9%) underwent surgery, while 33 did not due to a low ejection fraction or severe chronic bronchitis, or because the patient's family did not give consent. The patients' mean age was 81.7 (1.5) years, 61.5% were female, 18.4% had diabetes, 7.8% had had a previous infarction, and 32.7% had coronary disease. Three patients (2.9%) had a perioperative myocardial infarction, six (5.8%) had a stroke, and six (5.8%) had a permanent pacemaker. Four patients (3.8%) died during the first 30 days. The survival rates at 1, 2, 3, 4, 5 and 6 years were 90 (2.9), 81 (4.2), 78 (4.8), 75 (5.3), 65 (7.2) and 60 (8.2)%, respectively. The following predictors of long-term mortality were identified: creatinine level, emergency surgery, and reintervention because of bleeding. Some 76.3% of patients remained in New York Heart Association functional class I-IV., Conclusions: Aortic valve replacement can be performed successfully in patients aged >or=80 years with severe aortic stenosis; the complication rate was low, and the survival rate and long-term results were good. Predictors of mortality in this series were the creatinine level, emergency surgery, and reintervention because of bleeding.

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