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Background: Scarce data are available comparing infective endocarditis (IE) following surgical aortic valve replacement (SAVR) and transcatheter aortic valve replacement (TAVR). This study aimed to compare the clinical presentation, microbiological profile, management, and outcomes of IE after SAVR versus TAVR., Methods: Data were collected from the "Infectious Endocarditis after TAVR International" (enrollment from 2005 to 2020) and the "International Collaboration on Endocarditis" (enrollment from 2000 to 2012) registries. Only patients with an IE affecting the aortic valve prosthesis were included. A 1:1 paired matching approach was used to compare patients with TAVR and SAVR., Results: A total of 1688 patients were included. Of them, 602 (35.7%) had a surgical bioprosthesis (SB), 666 (39.5%) a mechanical prosthesis, 70 (4.2%) a homograft, and 350 (20.7%) a transcatheter heart valve. In the SAVR versus TAVR matched population, the rate of new moderate or severe aortic regurgitation was higher in the SB group (43.4% vs 13.5%; P < .001), and fewer vegetations were diagnosed in the SB group (62.5% vs 82%; P < .001). Patients with an SB had a higher rate of perivalvular extension (47.9% vs 27%; P < .001) and Staphylococcus aureus was less common in this group (13.4% vs 22%; P = .033). Despite a higher rate of surgery in patients with SB (44.4% vs 27.3%; P < .001), 1-year mortality was similar (SB: 46.5%; TAVR: 44.8%; log-rank P = .697)., Conclusions: Clinical presentation, type of causative microorganism, and treatment differed between patients with an IE located on SB compared with TAVR. Despite these differences, both groups exhibited high and similar mortality at 1-year follow-up., Competing Interests: Potential conflicts of interest. J. R.-C. has received institutional research grants, consulting fees, and honoraria for speaking engagements from Edwards Lifesciences, Medtronic, and Boston Scientific. V. P. has received received institutional research grants from Medtronic, Boston Scientific, and Microport. J. M. M. has received consulting honoraria and/or research grants from Angelini, Contrafect, Cubist, Genentech, Gilead Sciences, Janssen, Lysovant, Medtronic, MSD, Novartis, Pfizer, and ViiV Healthcare, outside the submitted work. N. B. has received institutional research grants from The Novo Nordisk Foundation, The Augustinus Foundation, The Kaj Hansen Foundation, and Health Insurance Denmark, outside the submitted work. N. M. has received personal fees from Edwards Lifesciences, Medtronic, Biotronik, Novartis, Sanofi Genzyme, AstraZeneca, Pfizer, Bayer, Abbott, Abiomed, and Boston Scientific, outside the submitted work. G. C. reports travel support from Angelini Pharma Spain to attend national and international scientific conferences. E. D.-M. reports grants or contracts from Pfizer, Angelini, Shionogi, Advanz Pharma, and Infectopharm; consulting fees from Roche, Genentech, and Pfizer; payment or honoraria for speaking engagements from Pfizer, Angelini, and Shionogi; and travel support from Biotest. All other authors report no potential conflicts. All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Conflicts that the editors consider relevant to the content of the manuscript have been disclosed., (© The Author(s) 2023. Published by Oxford University Press on behalf of Infectious Diseases Society of America. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Objectives: The economic crisis in Europe might have limited access to some innovative technologies implying an increase of waiting time. The purpose of the study is to evaluate the impact of waiting time on the costs and benefits of transcatheter aortic valve replacement (TAVR) for the treatment of severe aortic stenosis., Methods: This is a cost-utility analysis from the perspective of the Spanish National Health Service. Results of two prospective hospital registries (158 and 273 consecutive patients) were incorporated into a probabilistic Markov model to compare quality adjusted life years (QALYs) and costs for TAVR after waiting for 3-12 months, relative to immediate TAVR. We simulated a cohort of 1000 patients, male, and 80 years old; other patient profiles were assessed in sensitivity analyses., Results: As waiting time increased, costs decreased at the expense of lower survival and loss of QALYs, leading to incremental cost-effectiveness ratios for eliminating waiting lists of about 12,500 € per QALY. In subgroup analyses prioritization of patients for whom higher benefit was expected led to a smaller loss of QALYs. Concerning budget impact, long waiting lists reduced spending considerably and permanently., Conclusions: A shorter waiting time is likely to be cost-effective (considering commonly accepted willingness-to-pay thresholds in Europe) relative to 3 months or longer waiting periods. If waiting lists are nevertheless seen as unavoidable due to severe but temporary budgetary restrictions, prioritizing patients for whom higher benefit is expected appears to be a way of postponing spending without utterly sacrificing patients' survival and quality of life.

Background: We aimed to analyze causes, management, and outcomes of the unexpected need to abort sternotomy in aortic stenosis (AS) patients accepted for surgical aortic valve replacement (SAVR) in the transcatheter aortic valve implantation (TAVI) era., Methods: Cases of aborted sternotomy (AbS) were gathered from 5 centers between 2009 and 2014. A systematic review of all published cases in the same period was performed., Results: A total of 31 patients (71% males, 74±8years, LogEuroSCORE 11.9±7.4%) suffered an AbS (0.19% of all sternotomies). Main reasons for Abs included previously unknown porcelain aorta (PAo) in 83.9%, mediastinal fibrosis due to radiotherapy in 12.9%, and chronic mediastinitis in 3.2%. Median time between AbS and next intervention was 2.3months (IQR: 0.7-5.8) with no mortality within this period. Only a case was managed with open surgery. In 30 patients (96.8%) TAVI was performed with a rate of success of 86.7%. Three patients (9.7%) presented in-hospital death and 17 (54.8%) had in-hospital complications including heart failure (9.6%), major bleeding (6.9%), and acute kidney injury (9.6%). Older patients (76±8 vs. 70±8years, p=0.045), previous cardiac surgery (60% vs. 15.4%, p=0.029), and shorter time from AbS to next intervention (5.1±5 vs. 1±0.7months, p=0.001) were related to higher six-month mortality (22.6%)., Conclusions: The main reason for AbS was PAo. This entity was associated to a higher rate of complications and mortality, especially in older patients and with prior cardiac surgery. A preventive strategy in these subgroups might be based on imaging evaluation. TAVI was the most extended therapy., (Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.)

Background and Purpose: The risk of neurological damage following transcatheter aortic valve implantation (TAVI) vs. surgical aortic valve replacement (SAVR) in severe aortic stenosis patients deemed to be at intermediate surgical risk is unknown. In this target population, the degree of neurological damage was compared using brain diffusion-weighted magnetic resonance imaging (DW-MRI) and cognitive testing., Methods: Forty-six consecutive patients undergoing TAVI (78.0 ± 8.3 years; STS score 4.4 ± 1.7) and 37 patients undergoing SAVR (78.9 ± 6.2 years, STS score 4.7 ± 1.7) were compared. DW-MRI was performed in 67 patients (40 in TAVI vs. 27 in SAVR group) within the first 15 days post-procedure. A cognitive assessment was performed at baseline and at 3 months follow-up. The occurrence of potential cognitive impairment post-intervention was determined using the reliable change index (RCI)., Results: Baseline characteristics were comparable in TAVI and SAVR groups except for the presence of severe calcified aorta, which occurred more frequently in the TAVI group [17 (37 %) vs. 0 (0 %), p < 0.001]. Three patients presented a clinical stroke: 1 (2.2 %) in TAVI group vs. 2 (5.4 %) in SAVR group, (p = 0.58). No differences were observed in the rate of acute ischemic cerebral lesions detected by DWI in patients undergoing TAVI vs. SAVR [18 (45 %) in TAVI vs. 11 (40.7 %) in SAVR, adjusted OR 0.95; 95 % CI 0.25-3.65; p = 0.94]. TAVI was associated with a lower number of DWI lesions (adjusted OR 0.54; 95 % IC 0.37-0.79; p = 0.02). An older age was a predictor of the occurrence of acute lesions (OR 1.13; 95 % CI 1.03-1.23; p = 0.01), and the use of vitamin-K antagonist therapy had a protective effect (OR 0.25; 95 % CI 0.07-0.92; p = 0.037) regardless the type of intervention. Overall no significant changes were observed in global cognitive scores post-intervention (p = 0.23). The RCI showed mild cognitive decline in nine patients undergoing TAVI (26.4 %) and in six patients in the SAVR group (30.0 %) (p = 0.96). There was no association between the number and total volume of lesions and the occurrence of cognitive decline (CC Spearman 0.031, p = 0.85 and -0.011, p = 0.97, respectively)., Conclusions: TAVI and SAVR were associated with a similar rate of acute silent ischemic cerebral lesions in intermediate risk patients. Although acute lesions occurred very frequently in both strategies, their cognitive impact was not clinically relevant.

Objective: To evaluate cost-effectiveness of transfemoral TAVR vs surgical replacement (SAVR) and its determinants in patients with severe symptomatic aortic stenosis and comparable risk., Methods: Patients were prospectively recruited in 6 Spanish hospitals and followed up over one year. We estimated adjusted incremental cost-effectiveness ratio (ICER) (Euros per quality-adjusted life-year [QALY] gained) using a net-benefit approach and assessed the determinants of incremental net-benefit of TAVR vs SAVR., Results: We analyzed data on 207 patients: 58, 87 and 62 in the Edwards SAPIEN (ES) TAVR, Medtronic-CoreValve (MC) TAVR and SAVR groups respectively. Average cost per patient of ES-TAVR was €8800 higher than SAVR and the gain in QALY was 0.036. The ICER was €148,525/QALY. The cost of MC-TAVR was €9729 higher than SAVR and the QALY difference was -0.011 (dominated). Results substantially changed in the following conditions: 1) in patients with high preoperative serum creatinine the ICERs were €18,302/QALY and €179,618/QALY for ES and MC-TAVR respectively; 2) a 30% reduction in the cost of TAVR devices decreased the ICER for ES-TAVR to €32,955/QALY; and 3) imputing hospitalization costs from other European countries leads to TAVR being dominant., Conclusions: In countries with relatively low health care costs TAVR is not likely to be cost-effective compared to SAVR in patients with intermediate risk for surgery, mainly because of the high cost of the valve compared to the cost of hospitalization. TAVR could be cost-effective in specific subgroups and in countries with higher hospitalization costs., (Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.)

Aims: To determine the prevalence of aortic valve sclerosis (ASC) and stenosis (AS) in the elderly in a Mediterranean area and to identify associated clinical factors., Methods and Results: Population cross-sectional study in a random sample of 1068 people ≥65 years in a Mediterranean area. ASC was categorized as absent, mild-to-moderate, or moderate-to-severe depending on the severity of thickening and calcification. The relation between the severity of ASC and potential risk factors was assessed by multinomial logistic regression analysis. Some degree of thickening and/or calcification was present in 45.4%, of the sample, 73.5% in >85 years. AS prevalence was 3% for the total cohort and 7.4% in >85 years. Adjusting for gender it was found that age, smoking habit, hypertension, waist circumference, and ankle-brachial index <0.9 were associated with degrees of ASC. Except for waist circumference, there was a gradient between the magnitude of association and the severity of ASC. The OR for age was 1.56 (95% CI 1.39-1.76) for mild-to-moderate ASC and 2.03 (95% CI 1.72-2.4) for moderate-to-severe ASC, and for smoking habit 1.59 (95% CI 1.08-2.34) for mild-to-moderate ASC and 2.13 (95% CI 1.19-3.78) for moderate-to-severe ASC. Diabetes and renal impairment were associated with advanced but not with early stages of ASC., Conclusions: The prevalence of ASC and AS in people ≥65 years is similar to that reported in other regions. The gradient in the association of cardiovascular risk factors with the severity of ASC suggests that they may be causally implied in the pathogenesis of the disease.

Rheumatic Heart Disease (RHD) is well known to be an active inflammatory process which develops progressive calcification and leaflet thickening over time. The potential for statin therapy in slowing the progression of valvular heart disease is still controversial. Retrospective studies have shown that medical therapy is beneficial for patients with calcific aortic stenosis and recently for rheumatic valve disease. However, the prospective randomized clinical trials have been negative to date. This article discusses the epidemiologic risk factors, basic science, retrospective and prospective studies in valvular heart disease and a future clinical trial to target RHD with statin therapy to slow the progression of this disease. Recent epidemiological studies have revealed the risk factors associated with valvular disease include male gender, smoking, hypertension and elevated serum cholesterol and are similar to the risk factors for vascular atherosclerosis. An increasing number of models of experimental hypercholesterolemia demonstrate features of atherosclerosis in the aortic valve (AV), which are similar to the early stages of vascular atherosclerotic lesions. Calcification, the end stage process of the disease, must be understood as a prognostic indicator in the modification of this cellular process before it is too late. This is important in calcific aortic stenosis as well as in rheumatic valve disease. There are a growing number of studies that describe similar pathophysiologic molecular markers in the development of rheumatic valve disease as in calcific aortic stenosis. In summary, these findings suggest that medical therapies may have a potential role in patients in the early stages of this disease process to slow the progression of RHD affecting the valves. This review will summarize the potential for statin therapy for this patient population.

Aims: To critically review the available transcatheter aortic valve implantation techniques and their results, as well as propose recommendations for their use and development., Methods and Results: A committee of experts including European Association of Cardio-Thoracic Surgery and European Society of Cardiology representatives met to reach a consensus based on the analysis of the available data obtained with transcatheter aortic valve implantation and their own experience. The evidence suggests that this technique is feasible and provides haemodynamic and clinical improvement for up to 2 years in patients with severe symptomatic aortic stenosis at high risk or with contraindications for surgery. Questions remain mainly concerning safety and long-term durability, which have to be assessed. Surgeons and cardiologists working as a team should select candidates, perform the procedure, and assess the results. Today, the use of this technique should be restricted to high-risk patients or those with contraindications for surgery. However, this may be extended to lower risk patients if the initial promise holds to be true after careful evaluation., Conclusion: Transcatheter aortic valve implantation is a promising technique, which may offer an alternative to conventional surgery for high-risk patients with aortic stenosis. Today, careful evaluation is needed to avoid the risk of uncontrolled diffusion.

Background: Intervention is advised in selected asymptomatic patients with aortic valve disease. However, little is known regarding their actual management., Methods: The Euro Heart Survey was designed to evaluate practices. Severe isolated aortic stenosis (AS) was defined by a valve area < or = 0.6 cm2/m2 body surface area or mean gradient > or = 50 mm Hg. Severe aortic regurgitation (AR) was defined by a grade > or = 3/4. Patients were classified as asymptomatic when they were in New York Heart Association class I and were without angina. Decision to operate was analyzed by comparing patient characteristics with the American College of Cardiology/American Heart Association recommendations., Results: Of the 5001 patients, 136 had severe, isolated, and asymptomatic aortic valve disease (84 with AS and 52 with AR). Stress testing was performed in only 6 patients (4%). A decision to operate was taken in 45 patients (54%) with AS and 21 (40%) with AR. Indications for surgery were in accordance with the American College of Cardiology/American Heart Association guidelines in 57 patients (68%) with AS and in 41 (83%) with AR. However, the decision to operate was frequently based on class IIb recommendations in patients with AS. Intervention was "overused" in 18 patients with AS (21%) and in 5 (9%) with AR. Intervention was "underused" in 9 patients (11%) with AS and in 4 (8%) with AR., Conclusions: In asymptomatic patients with severe aortic valve disease, a decision to operate is frequently taken; and it is most often in agreement with guidelines, although often based on low-level recommendations.

Aims: To analyse decision-making in elderly patients with severe, symptomatic aortic stenosis (AS)., Methods and Results: In the Euro Heart Survey on valvular heart disease, 216 patients aged > or =75 had severe AS (valve area < or =0.6 cm(2)/m(2) body surface area or mean gradient > or =50 mmHg) and angina or New York Heart Association class III or IV. Patient characteristics were analysed according to the decision to operate or not. A decision not to operate was taken in 72 patients (33%). In multivariable analysis, left ventricular (LV) ejection fraction [OR = 2.27, 95% CI (1.32-3.97) for ejection fraction 30-50, OR = 5.15, 95% CI (1.73-15.35) for ejection fraction < or =30 vs. >50%, P = 0.003] and age [OR = 1.84, 95% CI (1.18-2.89) for 80-85 years, OR=3.38, 95% CI (1.38-8.27) for > or =85 vs. 75-80 years, P = 0.008] were significantly associated with the decision not to operate; however, the Charlson comorbidity index was not [OR = 1.72, 95% CI (0.83-3.50), P = 0.14 for index > or =2 vs. <2]. Neurological dysfunction was the only comorbidity significantly linked with the decision not to operate., Conclusion: Surgery was denied in 33% of elderly patients with severe, symptomatic AS. Older age and LV dysfunction were the most striking characteristics of patients who were denied surgery, whereas comorbidity played a less important role.