Cost-effectiveness of transcatheter aortic valve implantation in patients at low surgical risk in France: a model-based analysis of the Evolut LR trial

The recent paper by the corresponding author Jian-an WANG and his team entitled “Evaluation of the safety and efficacy of transcatheter aortic valve implantation in patients with a severe stenotic bicuspid aortic valve in a Chinese population” (Liu et al., 2015), published in the Journal of Zhejiang University-SCIENCE B (Biomedicine & Biotechnology), is very impressive. They evaluated the safety and efficacy of transcatheter aortic valve implantation (TAVI) in patients with bicuspid aortic valve (BAV) and tricuspid aortic valve (TAV) for the first time in the Chinese population. This paper reported 40 cases of clinical experience of TAVI, and first explicitly put forward the indication of stenosis in the BAV. The early and mid-term outcomes between BAV and TAV groups are almost the same, and the high procedural success rate and low complication rate of their study are encouraging. However, they found that the diameter of the ascending aorta in the BAV group ((40.4±4.4) mm) is larger than that in the TAV group. As we know, the BAV is often associated with ascending aortic dilatation that might be the result of hemodynamic changes and genetic backgrounds (Loscalzo et al., 2007). Replacement of the ascending aorta is indicated in patients with a BAV who are undergoing surgical aortic valve replacement (SAVR) if the diameter of the ascending aortic is >45 mm (Erbel et al., 2014). In their study, patients with ascending aortic diameter >50 mm were excluded, but two patients with dilated ascending aorta (48.4 and 49.4 mm, respectively) who were evaluated as surgical high risk (advanced age and poor heart function, etc.) underwent TAVI. However, there is still no clear evidence about the remodeling of ascending aorta and long-term outcomes of BAV patients with dilated ascending aorta after TAVI treatment. Follow-up research of the diameter of the ascending aorta and survival in these patients will be necessary and also very interesting. BAV is still deemed as a relative contraindication for TAVI (Vahanian et al., 2012), while the corresponding author Jian-an WANG and his team noted that patients with a severely stenotic BAV can be safely and effectively treated by TAVI (Liu et al., 2015). Meanwhile, 37.5% of the patients with BAV in their study were much higher than previous reports in Europe (3.0% to 9.2%) (Hayashida et al., 2013; Bauer et al., 2014). Therefore, evaluation of the safety and efficacy of TAVI in patients with a severe stenotic BAV in the Chinese population is valuable for clinical practice and clinical trials to expand the indication for TAVI. Compared with TAV patients, SAVR is generally performed at a younger age and lower surgical risk among BAV patients (Michelena et al., 2008; Lange et al., 2012). The clinical trials of TAVI in the lower surgical risk and younger patients are ongoing, which might expand the indication for TAVI. Accordingly, this study should contribute to the application of TAVI in more patients with aortic stenosis in the future.

Robotic aortic valve replacement

Transcatheter Aortic Valve Implantation in Patients With Severe Aortic Stenosis Hospitalized With Acute Heart Failure

BackgroundThe PARTNER 3 trial demonstrated clinical benefits of transcatheter aortic valve implantation (TAVI) with the SAPIEN 3 device, over surgical aortic valve replacement (SAVR) in patients with severe symptomatic aortic stenosis (sSAS) at low risk of surgical mortality. Using PARTNER 3 outcomes and Italy-specific costs data, this cost-utility analysis from the perspective of the Italian National Health System aimed to determine the cost-effectiveness of SAPIEN 3 TAVI versus SAVR in low risk sSAS patients in Italy. MethodsA two-stage cost-utility model was developed to estimate changes in both direct healthcare costs and health-related quality of life using TAVI with SAPIEN 3 compared with SAVR. Early adverse events associated with TAVI were captured utilising the PARTNER 3 dataset. These data fed into a Markov model that captured longer-term outcomes of patients, following TAVI or SAVR intervention. ResultsAnalysis findings estimated that TAVI with SAPIEN 3 offers benefits over SAVR in terms of increased quality-adjusted life years (QALYs) with only a small increase in costs, representing an incremental cost-effectiveness ratio/QALY gained of €2989 per patient. The results were robust, with TAVI with SAPIEN 3 remaining cost-effective across several scenarios and in probabilistic sensitivity analyses. ConclusionsThis model demonstrated that TAVI with SAPIEN 3 is likely to be cost effective compared with SAVR for the treatment of patients with sSAS who are at low risk of surgical mortality. These findings can inform policy makers to facilitate policy development in Italy on intervention selection for this patient population.

Low-Risk Transcatheter Versus Surgical Aortic Valve Replacement – An Updated Meta-Analysis of Randomized Controlled Trials

Dear Editor, Xiao et al evaluated the in-hospital outcomes of transcatheter aortic valve implantation (TAVI) in patients with and without chronic obstructive pulmonary disease (COPD) by analyzing the National Inpatient Sample (NIS) database from 2011 through 2014.1 Results showed that patients with COPD had significantly increased risk of respiratory complications and pneumonia after TAVI but without significant increase in in-hospital mortality, hospital length of stay, or nonrespiratory postoperative complications in comparison with the patients without COPD. We wanted to highlight a few points relevant to the article. First, given the administrative nature of the NIS database, it lacks details regarding the severity of COPD quantified by the definitive criteria, and the co-existence of pulmonary hypertension (PH), both of which are important factors for pre-procedural risk stratification and planning. Patients with mild COPD constitute a markedly different group than oxygen-dependent COPD. In particular, patients with very low forced expiratory volume in 1-second (<30% predicted) are at an increased risk of poor outcomes following TAVI.2 PH presents as a common finding in patients undergoing TAVI. It has been shown that invasive stratification of PH according to hemodynamic profile predicts response to therapy as well as 1-year mortality after TAVI.3 Second, the data regarding frailty, mobility, functional and nutritional status are not available in the NIS database, which are important considerations for clinical decision-making among patients with severe aortic stenosis and COPD. Third, this study was conducted between 2011 and 2014, when TAVI was mainly performed under general anesthesia, whereas, conscious sedation has recently gained popularity and may be associated with fewer respiratory complications.4 Also, it is quite likely that the majority of these patients referred for TAVI were inoperable and high-risk given the timeframe of this analysis. Nonetheless, we would like to commend the authors for conducting this excellent study which supports the effectiveness of TAVI among patients with concomitant COPD despite the increased risk of respiratory complications.

Background Transcatheter aortic valve implantation (TAVI) with the SAPIEN 3 device has recently shown significant clinical benefits, compared to surgical aortic valve replacement (SAVR), in patients at low risk for surgical mortality (PARTNER 3 trial, NCT02675114). Currently in Belgium, TAVI use is restricted to high-risk or inoperable patients with severe symptomatic aortic stenosis (sSAS). This cost-utility analysis aimed to assess whether TAVI with SAPIEN 3 could lead to potential cost-savings compared with SAVR, in the low-risk sSAS population in Belgium. Methods A previously published, two-stage, Markov-based cost-utility model was used. Clinical outcomes were captured using data from PARTNER 3 and the model was adapted for the Belgian context using cost data from the perspective of the Belgian National Healthcare System, indexed to 2022. A lifetime horizon was chosen. The model outputs included changes in direct healthcare costs, survival and health-related quality of life using TAVI versus SAVR. Results TAVI with SAPIEN 3 provides meaningful clinical and cost benefits over SAVR, in terms of an increase in quality-adjusted life years (QALYs) of 0.94 and cost-saving of €3 013 per patient. While initial procedure costs were higher for TAVI compared with SAVR, costs related to rehabilitation, disabling stroke, treated atrial fibrillation, and rehospitalization were lower. The cost-effectiveness of TAVI over SAVR remained robust in sensitivity analyses. Conclusion TAVI with SAPIEN 3 may offer a meaningful alternative intervention to SAVR in Belgian low-risk patients with sSAS, showing both clinical benefits and cost savings associated with post-procedure patient management.

Have We Entered the Era of “Code TAVR” and “Door-to-TAVR” Time?

Surgical aortic valve replacement (SAVR) is the commonly used approach for aortic valve replacement (AVR) in patients with aortic stenosis at low or intermediate surgical risk. However, transcatheter aortic valve replacement (TAVR) has emerged as an alternative to SAVR for AVR. This meta-analysis aims to assess the comparative efficacy and safety of TAVR versus SAVR in low-to-intermediate surgical risk patients by analyzing temporal trends in the outcomes of TAVR and SAVR at various follow-up intervals, providing a more detailed understanding. A thorough literature search was performed across PubMed/MEDLINE, Embase, and the Cochrane Library from their inception up to May 2024 to identify eligible randomized controlled trials (RCTs). Clinical outcomes were evaluated using a random-effects model to pool risk ratios (RRs) with 95% CIs. A total of 17 studies reporting data at different follow-ups for nine trials were included (n=9092). No statistically significant difference was observed between TAVR and SAVR for reducing all-cause death at 30 days, 1 year, and 2 years but significantly increased risk with TAVR at 5 years or longer follow-up (RR=1.13, 95% CI: 1.03-1.23). However, TAVR was associated with a significantly decreased risk for cardiac death at 1-year follow-up (RR=0.79, 95% CI: 0.64-0.96) and comparable risk for cardiac death at 30 days, 2 years, and 5 years or longer follow-up when compared with SAVR. No statistically significant difference was observed between TAVR and SAVR for reducing the risk of myocardial infarction (MI) at 30 days, 1 year, 2 years, and 5 years or longer follow-up.TAVR was associated with a significantly lower risk of major bleeding events at 30 days (RR=0.38, 95% CI: 0.21-0.67); lower risk of acute kidney injury (AKI) at 30 days (RR=0.38, 95% CI: 0.26-0.54) and 1 year (RR=0.58, 95% CI: 0.41-0.82) and lower risk of new onset or worsening atrial fibrillation (AF) at 30 days (RR=0.25, 95% CI: 0.18-0.34), 1 year (RR=0.26, 95% CI: 0.16-0.41) and 2 years (RR=0.32, 95% CI: 0.20-0.49) when compared with SAVR. However, TAVR was associated with a significantly increased risk of permanent pacemaker implantation (PPI) at 30 days (RR: 2.62, 95% CI: 1.40-4.91), at 1 year (RR: 2.19, 95% CI: 1.24-3.87), at 2 years (RR: 2.74, 95% CI: 1.31-5.71), and beyond 5 years (RR: 1.95, 95% CI: 1.20-3.15). TAVR was also associated with a significantly increased risk of prosthetic valve thrombosis at 2 years (RR=2.70, 95% CI: 1.08-6.71), though no significant association was observed at 30 days, 1 year, or 5 years. Similarly, no significant differences were observed in aortic-valve reintervention rates at 30 days, 2 years, or 5 years, but TAVR showed a significantly increased risk at 1 year (RR=1.98, 95% CI: 1.21-3.24). TAVR was associated with a significantly increased risk of major vascular complications at 30 days (RR=2.37, 95% CI: 1.38-4.04) and a significantly increased risk of TIA at 2 years (RR: 1.43, 95% CI: 1.02-2.00, I2=0%). The risk of hospitalizations was comparable between the groups. TAVR and SAVR demonstrated comparable rates of all-cause death up to 2 years of follow-up. However, at 5 years or longer follow-up, TAVR was associated with a higher risk of all-cause death. While TAVR showed certain procedural advantages, such as a lower risk of major bleeding, AKI, and new-onset or worsening AF, the choice between TAVR and SAVR in patients with low or intermediate surgical risk should consider long-term outcomes, with SAVR potentially being more favorable due to better survival observed on longer follow-up durations.

Introduction The aim of this systematic review and meta-analysis was to investigate the efficacy and safety of emergent transcatheter aortic valve implantation (TAVI) in patients with decompensated aortic stenosis (AS) by comparing the clinical outcomes with the patients who had received the elective TAVI. Methods By searching PubMed, EMBASE, and Cochrane databases, we obtained the studies comparing the clinical outcomes of emergent TAVI and elective TAVI. Finally, 14 studies were included. Results A total of 14 eligible articles with 73,484 patients were included in this meta-analysis. Emergent TAVI was associated with a higher mortality during hospitalization (HR 2.09, 95% CI [1.39 to 3.14]), 30 days (HR 2.29, 95% CI [1.69 to 3.10]), and 1 year (HR 1.96, 95% CI [1.55 to 2.49]). Consistently, the incidence of acute kidney injury (AKI) (RR 2.48, 95% CI [1.85 to 3.32]), dialysis (RR 2.37, 95% CI [1.95 to 2.88]), bleeding (RR 1.62, 95% CI [1.27 to 2.08]), major bleeding (RR 1.05, 95% CI [1.00 to 1.10]), and 30-day rehospitalization (RR 1.30, 95% CI [1.07, 1.58]) were more common in patients receiving emergent TAVI. No statistical differences were found in the occurrence rate of vascular complications (RR 1.11, 95% CI [0.90, 1.36]), major vascular complications (RR 1.14, 95% CI [0.52, 2.52]), permanent pacemaker (PPM) placement (RR 1.05, 95% CI [0.99, 1.11]), cerebrovascular events (RR 1.11, 95% CI [0.98, 1.25]), moderate to severe paravalvular leakage (PVL) (RR 1.23, 95% [CI 0.94 to 1.61]), and device success (RR 0.99, 95% CI [0.97, 1.01]). Conclusion Emergent TAVI is associated with some postoperative complications and increased mortality compared with elective TAVI. Emergent TAVI should be implemented cautiously and individually.

Recently, two randomized trials, the PARTNER 3 and the Evolut Low Risk Trial, independently demonstrated that transcatheter aortic valve replacement (TAVR) is non-inferior to surgical aortic valve replacement (SAVR) for the treatment of severe aortic stenosis in patients at low surgical risk, paving the way to a progressive extension of clinical indications to TAVR. We designed a meta-analysis to compare TAVR versus SAVR in patients with severe aortic stenosis at low surgical risk. The study protocol was registered in PROSPERO (CRD42019131125). Randomized studies comparing one-year outcomes of TAVR or SAVR were searched for within Medline, Scholar and Scopus electronic databases. A total of three randomized studies were selected, including nearly 3000 patients. After one year, the risk of cardiovascular death was significantly lower with TAVR compared to SAVR (Risk Ratio (RR) = 0.56; 95% CI 0.33–0.95; p = 0.03). Conversely, no differences were observed between the groups for one-year all-cause mortality (RR = 0.67; 95% CI 0.42–1.07; p = 0.10). Among the secondary endpoints, patients undergoing TAVR have lower risk of new-onset of atrial fibrillation compared to SAVR (RR = 0.26; 95% CI 0.17–0.39; p < 0.00001), major bleeding (RR = 0.30; 95% CI 0.14–0.65; p < 0.002) and acute kidney injury stage II or III (RR = 0.28; 95% CI 0.14–0.58; p = 0.0005). Conversely, TAVR was associated to a higher risk of aortic regurgitation (RR = 3.96; 95% CI 1.31–11.99; p = 0.01) and permanent pacemaker implantation (RR = 3.47; 95% CI 1.33–9.07; p = 0.01) compared to SAVR. No differences were observed between the groups in the risks of stroke (RR= 0.71; 95% CI 0.41–1.25; p = 0.24), transient ischemic attack (TIA; RR = 0.98; 95% CI 0.53–1.83; p = 0.96), and MI (RR = 0.75; 95% CI 0.43–1.29; p = 0.29). In conclusion, the present meta-analysis, including three randomized studies and nearly 3000 patients with severe aortic stenosis at low surgical risk, shows that TAVR is associated with lower CV death compared to SAVR at one-year follow-up. Nevertheless, paravalvular aortic regurgitation and pacemaker implantation still represent two weak spots that should be solved.

Transcatheter aortic valve replacement (TAVR) has emerged as a treatment option for severe aortic stenosis in patients at intermediate or high surgical risk. However, until recently there was insufficient evidence regarding the outcomes of TAVR compared to surgical aortic valve replacement (SAVR) for patients at low risk. We conducted a meta-analysis and systematic review of all randomized trials comparing the efficacy and safety of TAVR versus SAVR in patients at low surgical risk. Risk ratios (RR) and 95% confidence intervals (CIs) were calculated, using fixed- or random-effects model. Four trials were eligible for analysis and comprised a total of 2887 patients (1497 allocated to TAVR and 1390 allocated to SAVR group). TAVR was associated with a 39% relative risk reduction (RRR) of major adverse cardiac events (MACE) (absolute risk reduction ARR of 3.7%; RR 0.61; 95% CI 0.47-0.79); 39% RRR of overall mortality (ARR of 1.4%; RR 0.61; 95% CI 0.39-0.96) and 45% RRR of cardiovascular mortality (ARR of 1.3%; RR 0.55; 95% CI 0.33-0.90), 69% RRR of life threatening or disabling bleeding (ARR of 7.0%; RR 0.31; 95% CI 0.22-0.44), 73% RRR of new-onset atrial fibrillation (ARR of 29%; RR 0.27; 95% CI 0.20-0.35) and 73% RRR of acute kidney injury (ARR of 2.1%; RR 0.27; 95% CI 0.14-0.56) as compared with SAVR. In contrast, TAVR was associated with a 4.7-fold increased risk of new pacemaker (PM) implantation (RR 4.72; 95% CI 1.83-12.15), which was driven by use of self-expanding valves. TAVR in low-risk patients is superior to SAVR for the majority of outcomes.

Cost-Effectiveness of Transcatheter Versus Surgical Aortic Valve Replacement in Low-Risk Patients With Severe Aortic Stenosis

Transcatheter or Surgical Aortic Valve Replacement in Women With Small Annuli at Low or Intermediate Surgical Risk

This case report details the successful use of JenaValve for transcatheter aortic valve implantation in a male patient in his early 50s with severe aortic regurgitation. The patient had multiple comorbidities, including chronic kidney disease and heart failure, increasing the risk of surgical intervention. JenaValve, a second-generation device with unique positioning and anchoring mechanisms, was deployed successfully, resulting in immediate improvements in cardiac function without significant regurgitation or paravalvular leakage. This case highlights the potential of transcatheter aortic valve implantation as a viable alternative to surgical aortic valve replacement in patients with severe aortic regurgitation, emphasizing the importance of technological advancements and a multidisciplinary approach in managing complex cardiovascular cases. Long-term follow-up is essential to assess the durability of the implanted valve and the patient’s overall prognosis.