Transcatheter Aortic-Valve Replacement In Intermediate-Risk Patients Research Articles

Cost-Effectiveness of Aortic Valve Replacement in Low- and Intermediate-Risk Chinese Patients With Severe Aortic Stenosis.

Transcatheter aortic valve replacement (TAVR) remains debated as an alternative to surgical aortic valve replacement (SAVR). We aimed to evaluate the cost-effectiveness of aortic valve replacement strategies in low- and intermediate-risk patients with severe aortic stenosis in China. A decision-analytic model combining decision tree and Markov model was developed to compare outcomes of universal SAVR, universal TAVR, and a risk-based strategy (SAVR in low-risk patients and TAVR in intermediate-risk patients) in a hypothetical cohort of 75-year-old patients with aortic stenosis within the perspective of the Chinese health care system. A meta-analysis was performed to derive the clinical inputs; the 2019 to 2021 claims data from Shaanxi Province were used for cost analysis, and quality of life was measured using EuroQoL-5D. One-way and probabilistic (10 000 Monte Carlo simulations) sensitivity analyses were conducted to examine the robustness of model results. Primary outcomes included total costs, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratio (ICER). Universal TAVR gained the most QALYs (6.76 QALYs) with the highest costs (USD 58 949). Compared with universal SAVR, the risk-based strategy gained 0.12 additional QALYs at higher costs (USD 14 046); the ICER (117 048 USD/QALY) exceeded the willingness-to-pay threshold (37 657 USD/QALY, 3-fold gross domestic product per capita in China). The ICER of universal TAVR versus universal SAVR (80 526 USD/QALY) also exceeded the willingness-to-pay threshold. Sensitivity analysis showed that universal TAVR would be cost-effective if TAVR valve costs were <USD 21 477 (>44.23% cost reduction). Subgroup analysis showed that universal TAVR and risk-based strategy remained not cost-effective compared with universal SAVR in both low-risk (ICER of 64 414 USD/QALY) and intermediate-risk (ICER of 124 851 USD/QALY) patients. In 10 000 Monte Carlo simulations, the probabilities of being cost-effective for universal SAVR, universal TAVR, and risk-based strategy were 89.81%, 10.14%, and 0.05%, respectively. The risk-based strategy and universal TAVR appeared not to be cost-effective versus universal SAVR in low- and intermediate-risk patients with severe aortic stenosis in China.

Transcatheter versus surgical aortic valve replacement in intermediate-risk patients: Evidence from a meta-analysis.

We performed a meta-analysis to evaluate the efficacy and safety of transcatheter aortic valve replacement (TAVR) in comparison to surgical aortic valve replacement (SAVR) in intermediate-risk patients. TAVR is an established treatment option in high-risk patients with severe aortic valve stenosis (AS). There are fewer data regarding efficacy of TAVR in intermediate-risk patients. Databases were searched through April 30, 2016 for studies that compared TAVR with SAVR for the treatment of intermediate-risk patients with severe AS. We calculated summary risk ratios (RRs) and 95% confidence intervals (CIs) with the random-effects model. The analysis included 4,601 patients from 7 studies (2 randomized and 5 observational). There was no significant difference in all-cause mortality between the two groups after mean follow-up of 1.15 years [14.7% with TAVR vs 15.4% with SAVR; RR 0.93; 95% CI 0.77-1.12]. TAVR resulted in lower rates of acute kidney injury [number needed to treat (NNT) = 26], major bleeding (NNT = 4), and atrial-fibrillation (NNT = 6), but higher rates of major vascular complications [number needed to harm (NNH)= 18], and moderate/severe aortic regurgitation (NNH = 13). The rate of permanent-pacemaker implantation was significantly higher with TAVR in observational studies (RR 2.31; 95% CI 1.22-2.81), but not in RCTs (RR 1.21; 95% CI 0.93-1.56). No significant difference in the rate of stroke or myocardial infarction was observed. Our analysis of mid-term results showed that TAVR has similar clinical efficacy to SAVR in intermediate-risk patients with severe AS, and can be a suitable alternative to surgical valve replacement. © 2017 Wiley Periodicals, Inc.

Economic Implications of Transcatheter Aortic Valve Replacement in Patients at Intermediate Surgical Risk.

Population aging and other factors are propelling healthcare spending on a perpetually increasing trajectory. More than ever, we must carefully assess the economic impact of adopting new medical technologies into clinical practice. Recently, transcatheter aortic valve replacement (TAVR) has emerged as a remarkable advance in the treatment of aortic stenosis. Studies have shown that TAVR in patients with aortic stenosis at extreme and high surgical risk provides good economic, as well as, clinical value.1–3 As the role of TAVR is now considered for intermediate-risk patients, questions about value must be asked and answered again. To understand the cost-effectiveness of TAVR in intermediate-risk patients, it is helpful to consider the lessons learned in higher-risk patients. First, it is apparent that the major offsets for the increased technology cost of TAVR in comparison with surgical aortic valve replacement (SAVR) are decreased hospital length of stay (LOS) and a reduced need for postacute rehabilitation services. With TAVR prices currently in excess of $30 000 per device in the United States (in comparison with ≈$5000 per surgical valve), reductions in LOS must be quite large for TAVR to pay for itself. If the costs of TAVR are higher than SAVR, the cost-effectiveness of TAVR from a societal perspective is strongly affected by the presence or absence of a mortality benefit with TAVR. In the absence of a survival difference, the advantages of TAVR …

Transcatheter Aortic Valve Replacement in Lower Surgical Risk Patients: Review of Major Trials and Future Perspectives.

Following the first successful transcatheter aortic valve replacement (TAVR) in 2002, TAVR has globally evolved to become a standard procedure in high-risk patients. Surgical aortic valve replacement in non-high-risk patients remains the gold standard for treatment of severe aortic stenosis. However, a paradigm shift appears to be occurring in the direction of treating lower-risk patients, and several studies have suggested its impact on clinical outcomes. In this review, we highlight the current status of TAVR in intermediate-risk patients and review major trials including Placement of AoRTic TraNscathetER (PARTNER) 2A randomized intermediate-risk trial using SAPIEN XT (Edwards Lifesciences Corp, Irvine, CA) recently presented with excellent outcomes and the lowest major complications rate at the American College of Cardiology's 65th Annual Scientific Session in Chicago. Clinical trials in low-risk patients using SAPIEN 3 and CoreValve Evolut R have just been launched, and they are going to be important milestones in the TAVR field.

Transcatheter versus surgical aortic valve replacement in intermediate risk patients: a meta-analysis.

Transcatheter aortic valve replacement (TAVR) has been approved in patients with high or prohibited surgical risk for surgery for treatment of severe symptomatic aortic stenosis. Prospective studies examining the benefits of TAVR in intermediate risk patients are ongoing. Other smaller studies including lower risk patients have been conducted, but further meta-analysis of these studies is required to draw more broad comparisons. A Medline search was conducted using standard methodology to search for clinical trials and observational studies including intermediate risk patients. We limited our meta-analysis to studies matching patient populations by propensity scores or randomization and examined clinical outcomes between TAVR and surgical aortic valve replacement (SAVR). Analysis of the TAVR and SAVR cohorts revealed no significant differences in the outcomes of 30-day [OR (95% CI): 0.85 (0.57, 1.26)] or 1-year mortality [OR (95% CI): 0.96 (0.75, 1.23)]. A trend towards benefit with TAVR was noted in terms of neurological events and myocardial infarction (MI) without statistical significance. A statistically significant decrease in risk of post-procedural acute renal failure in the TAVR group [OR (95% CI): 0.52 (0.27, 0.99)] was observed, but so was a significantly higher rate of pacemaker implantations for the TAVR group [OR (95% CI): 6.51 (3.23, 13.12)]. We conclude that in intermediate risk patients undergoing aortic valve replacement, the risk of mortality, neurological outcomes, and MI do not appear to be significantly different between TAVR and SAVR. However, there appears to be a significant reduction in risk of acute renal failure at the expense of an increased risk of requiring a permanent pacemaker in low and intermediate risk patients undergoing TAVR compared to SAVR.