Cost-Effectiveness of SAPIEN 3 Transcatheter Aortic Valve Implantation Versus Surgical Aortic Valve Replacement in German Severe Aortic Stenosis Patients at Low Surgical Mortality Risk

Abstract

Introduction: In the randomized PARTNER 3 trial, transcatheter aortic valve implantation (TAVI) with the SAPIEN 3 device significantly reduced a composite of all-cause death, stroke, and rehospitalization, compared with surgical aortic valve replacement (SAVR), in patients with severe symptomatic aortic stenosis and low risk of surgical mortality. Furthermore, TAVI has been shown to be cost-effective in low-risk patients, compared with SAVR, in a number of countries. This study aimed to determine the cost-effectiveness of TAVI with SAPIEN 3 versus SAVR in Germany. Methods: A previously published two-stage Markov-based model that captured clinical outcomes from the PARTNER 3 trial was adapted for the German context using the German Statutory Health Insurance perspective. The model had a lifetime horizon. The cost-utility analysis estimated changes in direct healthcare costs as well as survival and health-related quality of life using TAVI with SAPIEN 3 compared with SAVR. Results: TAVI with SAPIEN 3 increased qualityadjusted life years (QALYs) by ? 0.72 at an increased cost of €8664 per patient. The incremental cost-effectiveness/QALY ratio was €12,037, which fell below that of other cardiovascular interventions in use in Germany. The

Is transcatheter aortic valve implantation for aortic stenosis cost-effective?

“…The results found that TAVI dominated SAVR in terms of an increase in QALYs of 0.94 and cost saving of e3013 per patient, thus providing meaningful clinical and cost benefits over SAVR. The result is aligned with a range of published CEAs for other European countries, with the exception of England (Figure 2) [10][11][12][13][14][15][16].…”

Improving access to transcatheter aortic valve implantation across Europe by restructuring cardiovascular services: An expert council consensus statement

“…The value of TAVI for intermediate‐ and high‐risk patients is relatively well proven (Table 2), 48,52–58 and the cost‐effectiveness of TAVI for low‐risk patients using contemporary devices, procedural planning, and optimized intraprocedural and postprocedure care may be expected to provide advantages in survival and QoL 17,59–61 . TAVI has been shown to offer meaningful benefits over SAVR in providing both savings in healthcare costs and in improvement in health‐related QoL for patients with SAS at low risk of surgical mortality in multiple healthcare systems across Europe, United States, and Canada 60,62–65 . Data from the United States suggest that continued efforts to expand the use of both the minimalist approach and a streamlined TAVI clinical pathway are likely to substantially improve the cost‐effectiveness of this procedure 18 …”

“…17,59-61 TAVI has been shown to offer meaningful benefits over SAVR in providing both savings in healthcare costs and in improvement in health-related QoL for patients with SAS at low risk of surgical mortality in multiple healthcare systems across Europe, United States, and Canada. 60,[62][63][64][65] Data from the United States suggest that continued efforts to expand the use of both the minimalist approach and a streamlined TAVI T A B L E 2 Cost-effectiveness of TAVI across the spectrum of surgical risk. | 553 clinical pathway are likely to substantially improve the costeffectiveness of this procedure.…”

Abordagens contemporâneas no tratamento da estenose aórtica

“…Nos últimos anos, várias abordagens contemporâneas têm sido desenvolvidas para tratar a estenose aórtica, incluindo a substituição valvar aórtica transcateter (TAVR) e a cirurgia valvar aórtica minimamente invasiva (MIAVR). Essas novas abordagens apresentam muitas vantagens em relação às técnicas convencionais, como a cirurgia de válvula aórtica aberta, incluindo menor tempo de recuperação, menor tempo de internação hospitalar e menor trauma cirúrgico (CHEN CG, et al, 2022;KUCK KH, et al, 2023) A TAVR é uma técnica minimamente invasiva que envolve a colocação de uma nova válvula aórtica através de um cateter inserido na artéria femoral. A técnica é indicada para pacientes com alto risco cirúrgico ou que não são candidatos à cirurgia valvar aórtica aberta convencional.…”

“…A técnica é indicada para pacientes com alto risco cirúrgico ou que não são candidatos à cirurgia valvar aórtica aberta convencional. A cirurgia valvar aórtica minimamente invasiva, por sua vez, é realizada através de pequenas incisões na parede torácica e oferece uma recuperação mais rápida e menos dolorida para o paciente em comparação com a cirurgia valvar aórtica aberta convencional (KUCK KH, et al, 2023).…”