Transcatheter aortic valve replacement and the value of increasing treatment for severe symptomatic aortic stenosis: a plain language summary
Plain Language Summary What is this summary about? This article summarizes an economic evaluation of transcatheter aortic valve replacement (TAVR), a treatment for severe symptomatic aortic stenosis (SSAS). SSAS occurs when the aortic valve, which allows blood to leave the heart, becomes very narrow. This reduces blood flow to the body, causing symptoms like tiredness, chest pain, dizziness, or fainting. Treating SSAS requires replacing the valve. Untreated SSAS results in heart failure and death. Before TAVR, SSAS patients had two options, medical management and surgical aortic valve replacement (SAVR). Medical management helps with symptoms but does not replace the valve, leading patients to eventually die from SSAS. SAVR replaces the valve through open-heart surgery, which is invasive, involving making a large cut through the chest bone. Concerns about this invasiveness led many patients to avoid SAVR, leaving their SSAS untreated. TAVR was introduced in 2010. It is less invasive than SAVR, involving inserting a new valve through a small cut in the leg. TAVR has become popular and twice as many patients now undergo TAVR compared to SAVR. We measure TAVR’s net benefits as the value of its health benefits minus its healthcare costs. We measure these net benefits in three patient groups aged 65 and above in the United States. Group 1 patients are ineligible for SAVR, so TAVR is their only treatment option. Group 2 patients would have received SAVR if TAVR were not available. Group 3 patients are eligible for SAVR but concerned about its invasiveness, and so would have stayed untreated without TAVR. Economic evaluation: A type of study that measures the benefits and costs of a treatment like TAVR and judges whether the benefits are sufficiently large to justify the costs (or put another way, whether the technology represents good value-for-money). Transcatheter aortic valve replacement (TAVR): Replacement of the aortic valve in SSAS patients using a thin tube called a catheter that enters the body through a small cut near the leg and delivers and installs a valve replacement. New treatment option for SSAS from 2010 onwards. A minimally invasive treatment. Aortic stenosis (AS): A heart condition where a heart valve called the aortic valve becomes very narrow, forcing the heart to work harder and limiting blood flow to the rest of the body. Severe Symptomatic Aortic Stenosis (SSAS): Severe form of AS when the narrowing of the aortic valve is significant and accompanied by symptoms like fatigue, chest pain, shortness of breath, dizziness, or fainting. What were the key takeaways? Net benefits per patient are significant in all groups, roughly equal in groups 1 and 2, and over six times larger in group 3. When net benefits are added up across patients, group 3’s total net benefit is 30 times larger than that of groups 1 and 2 combined. What are the main conclusions? Past studies ignored TAVR’s value in helping treat patients who might go untreated because of concerns over SAVR’s invasiveness. But this is TAVR’s largest value to SSAS patients. Our findings support continuing and increasing access to TAVR among SSAS patients, especially those who may go untreated because of concerns about invasive treatment. Aortic valve: One of the four heart valves. It connects the left side of the heart with the aorta, which is the large artery carrying oxygen-rich blood to the body. The aortic valve controls blood flow into the aorta, ensuring it moves in one direction. Medical management (MM): Involves medication and monitoring of SSAS patients but no treatment in the form of valve replacement. Associated with high risk of death. Surgical aortic valve replacement (SAVR): Replacement of the aortic valve in SSAS patients through open heart surgery. The sole treatment option for SSAS before 2010. A highly invasive treatment given its use of open-heart surgery. This is an abstract of the Plain Language Summary of Publication article. View the full Plain Language Summary PDF of this article to read the full-text Link to original article here
- Front Matter
- 10.1053/j.jvca.2021.11.034
- Nov 27, 2021
- Journal of Cardiothoracic and Vascular Anesthesia
Self-Expanding Versus Balloon-Expandable Valve: Are We at the Cusp of Delivering a Perfect Transcatheter Aortic Valve?
- Front Matter
3
- 10.1053/j.jvca.2021.06.007
- Jun 11, 2021
- Journal of Cardiothoracic and Vascular Anesthesia
The Deployment of Valve Academic Research Consortium 3 (VARC-3): New Endpoints, Broader Definitions, and Plenty of Unanswered Questions
- Research Article
1
- 10.1161/circoutcomes.112.969766
- Nov 1, 2012
- Circulation: Cardiovascular Quality and Outcomes
The following are highlights from the new series, Circulation: Cardiovascular Quality and Outcomes Topic Reviews. This series will summarize the most important manuscripts, as selected by the Editor, which have been published in the Circulation portfolio. The objective of this new series is to provide our readership with a timely, comprehensive selection of important papers that are relevant to the quality and outcomes as well as general cardiology audience. The studies included in this article represent the most significant research in the area of valvular heart disease. ( Circ Cardiovasc Quality and Outcomes . 2012;5:-e103.) In recent years, no field of clinical cardiology has experienced a great influx of transformational therapeutic options as has the area of valvular heart disease. Treatment of severe aortic stenosis (AS) has been revolutionized by transcatheter aortic valve replacement (TAVR), which has been shown to improve life expectancy and functional outcomes in patients with inoperable AS1,2 and to have short-term outcomes comparable to surgical aortic valve replacement (AVR) in patients at high perioperative risk.3,4 Analogously, mitral valve disease has been amenable to percutaneous valve replacement,5,6 as well as clipping procedures7 that can substantively reduce severe mitral regurgitation (MR) and improve functional outcomes. Even right-sided heart disease involving valves in pulmonary8,9 and tricuspid10 positions has been treated successfully with endovascular techniques. Yet, even with this growing focus on percutaneous valvular interventions, open surgical techniques remain the dominant treatment strategies and standard of care for most advanced lesions. Surgical valve repair and replacement account for 10% to 20% of all cardiac surgical procedures,11–13 approximately two thirds of which are for AS.11–13 For patients undergoing surgery, there remains considerable debate about risk stratification,14 intraoperative technique,15 and postoperative …
- Front Matter
- 10.1016/j.athoracsur.2019.02.038
- Mar 22, 2019
- The Annals of thoracic surgery
The Devoted Grandma: Is a Social Indication for TAVR Acceptable?
- Front Matter
1
- 10.1053/j.jvca.2022.05.017
- May 18, 2022
- Journal of Cardiothoracic and Vascular Anesthesia
The AVATAR Trial for Severe Asymptomatic Aortic Stenosis: Wait or Operate?
- Front Matter
50
- 10.1016/j.jtcvs.2020.10.078
- Nov 16, 2020
- The Journal of Thoracic and Cardiovascular Surgery
Robotic aortic valve replacement
- Research Article
19
- 10.1161/circimaging.113.000334
- Jul 1, 2013
- Circulation: Cardiovascular Imaging
Senile calcific aortic stenosis (AS) is the most common acquired valvular heart disease with an increasing prevalence attributable to an aging population. Survival is poor in patients with severe or critical AS, chiefly after the onset of symptomology that primarily includes angina, dyspnea, or syncope. On the onset of symptoms, mortality occurs at very high rates during the ensuing 2 to 3 years.1 Until recently, surgical aortic valve replacement represented the sole therapy that definitive reduced mortality and morbidity in patients with severe symptomatic AS, with medical therapy generally ineffective of these patients. Given the advanced age commonly associated with severe AS, a high proportion of these patients are denied surgical intervention because of multiple comorbidities and excessively high surgical risk.2 Recently, transcatheter aortic valve replacement (TAVR) has emerged as a novel disruptive technology that serves an alternative therapy to surgical AVR and has been shown to be an effective therapy in nonoperable and high-risk patients with severe symptomatic AS.3,4 TAVR was first described in humans by Cribier et al in 20025 by a transvenous approach delivered in an antegrade fashion. This technique requires a transseptal puncture and passage of the aortic stent valve across the mitral valve to the aortic position. Subsequently, array of alternative transvascular approaches have arisen, including transfemoral, transaortic, trans-subclavian, and aortic methods. Of these, the retrograde transarterial approach through the femoral artery, developed by Webb et al,6 has been the commonly used approach, with >60 000 such procedures performed worldwide to date. To date, the global experience with TAVR as documented in both single and multicenter registries as well as through multicenter trials have shown good clinical outcomes with improvement in hemodynamic and clinical status, establishing TAVR to be a feasible alternative therapy to traditional surgical aortic valve …
- Front Matter
- 10.1016/j.xjon.2022.01.023
- Feb 24, 2022
- JTCVS Open
Transcatheter aortic valve replacement valve-in-valve: Future implications for the surgeon
- Research Article
1
- 10.1161/circulationaha.113.005947
- Sep 24, 2013
- Circulation
<i>Circulation</i> Editors’ Picks
- Research Article
15
- 10.1016/j.carrev.2019.08.003
- Aug 12, 2019
- Cardiovascular revascularization medicine : including molecular interventions
Low-Risk Transcatheter Versus Surgical Aortic Valve Replacement – An Updated Meta-Analysis of Randomized Controlled Trials
- Research Article
- 10.1016/j.cjca.2021.07.073
- Oct 1, 2021
- Canadian Journal of Cardiology
BUDGET IMPACT ANALYSIS OF TRANSCATHETER AORTIC VALVE REPLACEMENT COMPARED TO SURGICAL AORTIC VALVE REPLACEMENT IN LOW-RISK AORTIC STENOSIS PATIENTS: A CANADIAN PERSPECTIVE
- Research Article
16
- 10.1161/circoutcomes.122.009712
- Jun 1, 2023
- Circulation: Cardiovascular Quality and Outcomes
Target Aortic Stenosis: A National Initiative to Improve Quality of Care and Outcomes for Patients With Aortic Stenosis.
- Research Article
- 10.57187/s.3558
- Oct 24, 2024
- Swiss medical weekly
The 2021 European Society of Cardiology Guidelines on valvular heart disease recommend transcatheter aortic valve implantation (TAVI) for patients with symptomatic severe aortic stenosis at low surgical risk and age ≥75 years who are suitable for a transfemoral approach (recommendation class IA) based on two large randomised controlled trials (PARTNER 3 and Evolut Low Risk) comparing transcatheter aortic valve implantation with surgical aortic valve replacement (SAVR). Whether such an approach is cost-effective in Switzerland remains unclear. The aim of this cost-utility analysis was to compare transcatheter aortic valve implantation with SAPIEN 3 versus surgical aortic valve replacement in symptomatic severe aortic stenosis patients at low risk of surgical mortality from the perspective of Swiss compulsory health insurance using data from the PARTNER 3 trial (reflecting specifically the safety and efficacy of the SAPIEN 3 TAVI device). A previously published two-stage Markov-based model that captured clinical outcomes from the PARTNER 3 trial was adapted from the perspective of the Swiss compulsory health insurance system, using local or geographically close general population mortality and utility data, unit costs and medical resource use from publicly available sources and based on expert opinion. The model had a lifetime horizon with a 3% yearly discounting factor. The cost-utility analysis estimated changes in both direct healthcare costs and health-related quality-adjusted life years for transcatheter aortic valve implantation compared with surgical aortic valve replacement in patients with symptomatic severe aortic stenosis at low risk of surgical mortality. Overall, transcatheter aortic valve implantation with SAPIEN 3 resulted in lifetime costs per patient of CHF 79,534 and quality-adjusted life years per patient of 9.64, compared with surgical aortic valve replacement lifetime costs and quality-adjusted life years per patient of CHF 76,891 and 8.96, respectively. Compared with surgical aortic valve replacement, transcatheter aortic valve implantation was estimated to offer an incremental improvement of +0.68 quality-adjusted life years per patient at an increased cost of +CHF 2643 per patient over a lifetime horizon. The incremental cost-effectiveness ratio was CHF 3866 per quality-adjusted life year gained and remained below CHF 50,000 per quality-adjusted life year gained across several sensitivity analyses. This analysis suggests that transcatheter aortic valve implantation using the SAPIEN 3 device is likely to be a highly cost-effective alternative for symptomatic severe aortic stenosis patients at a low risk of surgical mortality, treated in the contemporary Swiss setting. These findings may help to inform a holistic approach when making policy decisions for the management of this patient group.
- Research Article
- 10.1093/eurheartj/ehz748.0602
- Oct 1, 2019
- European Heart Journal
P1851Long-term outcomes of transcatheter versus surgical aortic valve replacement in low risk, elderly patients with severe aortic stenosis
- Research Article
- 10.1161/circoutcomes.8.suppl_2.230
- May 1, 2015
- Circulation: Cardiovascular Quality and Outcomes
Background: In the current era of surgical and transcatheter aortic valve replacement (AVR), patients with severe symptomatic aortic stenosis (AS) receiving medical management after referral to a valve treatment center have not been well-described. Methods: The ACC Championing Care for the Patient with AS initiative involved 454 patients referred for assessment of AS treatment options to 9 US valve treatment centers from 11/2012 to 6/2014. We compared clinical characteristics of patients with severe symptomatic AS receiving medical management versus AVR using chi-square, Fisher’s exact, and t-tests. We identified reasons for medical management using summary statistics. Results: Among 454 patients referred to a valve center, 42 (9%) received medical management for insufficient AS severity, 76 (17%) received medical management despite having severe symptomatic AS, and 336 (74%) underwent AVR. Patients receiving medical management despite severe symptomatic AS were older with higher STS predicted mortality than patients treated with AVR (Table). Common reasons for medical management were patient preference (43%, including waiting for commercial TAVR), medical futility (17%), inoperability (11%, including infeasible aortic annulus for TAVR), and temporary bridging with valvuloplasty (15%). Conclusions: In the current era of transcatheter and surgical AVR, medical management often occurs among patients with severe symptomatic AS referred for AVR. As medical futility, inoperability, and patient preferences commonly contribute to this decision, both valve treatment centers and referring physicians should be well versed in supportive care strategies to improve health outcomes in these patients.
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