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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: 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: 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.

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.)

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.)

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.)

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: To determine the prognostic value of pro B-type natriuretic peptide (pro-BNP) to predict mortality after transcatheter aortic valve implantation (TAVI). Logistic EuroSCORE (LES) overestimates observed mortality after TAVI. A new risk score specific to TAVI is needed to accurately assess mortality and outcome., Methods: Eighty-five patients were included. Indications for TAVI were nonoperable or surgically high-risk patients (LES>20%). Pro-BNP was measured 24h before the procedure. Cox proportional hazards model was used to evaluate clinical factors. The predictive accuracy of these Cox models was determined by using time-dependent receiver operating characteristic (ROC) curves., Results: Pro-BNP levels (log-transformed) were significantly higher in non-survivors than in survivors at 30 days (3.36 ± 0.43 vs. 3.81 ± 0.43, p<0.004) and at the end of follow-up (3.34 ± 0.42 vs. 3.63 ± 0.48, p<0.011). Multivariate analysis revealed that only increased log pro-BNP levels were associated with higher mortality rate at short [hazard ratio (HR) (95% confidence intervals (CI)]=5.35 (1.74-16.5), p=0.003] and long-term follow-ups [HR=11 (CI: 1.51-81.3), p=0.018]. LES was not associated with increased mortality at either time point [HR=1.03 (CI: 0.95-1.10), p=0.483 and HR=1.03 (CI: 0.98-1.07), p=0.230, respectively]. At 30, 90, 180, and 365 days, the c-index was 0.72 for log pro-BNP and 0.63 for LES (p=0.044)., Conclusion: Pre-procedure log transform of plasma pro-BNP levels are an independent and strong predictor of short- and long-term outcomes after TAVI and are more discriminatory than LES., (Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.)

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.)