Cost-utility analysis of TAVI compared with surgery in patients with severe aortic stenosis at low risk of surgical mortality in the Netherlands.

BACKGROUND: There is growing evidence to support the benefits of transcatheter aortic valve implantation (TAVI) over surgical aortic valve replacement (SAVR) in patients with symptomatic severe aortic stenosis (sSAS) who are at high- or intermediate-risk of surgical mortality. The PARTNER 3 trial showed clinical benefits with SAPIEN 3 TAVI compared with SAVR in patients at low risk of surgical mortality. Whether TAVI is also cost-effective compared with SAVR for low-risk patients in the Dutch healthcare system remains uncertain. This article presents an analysis using PARTNER 3 outcomes and costs data from the Netherlands to inform a cost-utility model and examine cost implications of TAVI over SAVR in a Dutch low-risk population. METHODS: A two-stage cost-utility analysis was performed using a published and validated health economic model based on adverse events with both TAVI and SAVR interventions from a published randomized low risk trial dataset, and a Markov model that captured lifetime healthcare costs and patient outcomes post-intervention. The model was adapted using Netherlands-specific cost data to assess the cost-effectiveness of TAVI and SAVR. Uncertainty was addressed using deterministic and probabilistic sensitivity analyses. RESULTS: TAVI generated 0.89 additional quality-adjusted life years (QALYs) at a €4742 increase in costs per patient compared with SAVR over a lifetime time horizon, representing an incremental cost-effectiveness ratio (ICER) of €5346 per QALY gained. Sensitivity analyses confirm robust results, with TAVI remaining cost-effective across several sensitivity analyses. CONCLUSIONS: Based on the model results, compared with SAVR, TAVI with SAPIEN 3 appears cost-effective for the treatment of Dutch patients with sSAS who are at low risk of surgical mortality. Qualitative data suggest broader societal benefits are likely and these findings could be used to optimize appropriate intervention selection for this patient population.

Outcomes of emergent cardiac surgery after transcatheter aortic valve implantation.

OBJECTIVE: The aim of this study was to evaluate the reasons for emergent cardiac surgery (ECS) after transcatheter aortic valve implantation (TAVI) and assess outcomes of these patients. METHODS: All patients undergoing ECS following a complicated TAVI procedure at a high-volume TAVI centre in the Netherlands from 1 January 2008 to 1 April 2022 were included. Baseline and procedural characteristics and outcome data (procedural, 30-day and 1­year mortality, in-hospital stroke, 30-day pacemaker implantation, 30-day vascular complications, 30-day deep sternal wound infections and 30-day re-exploration) were collected from patient files and analysed using descriptive statistics. RESULTS: During the study period, 16 of 1594 patients (1.0%) undergoing TAVI required ECS. The main reason for ECS was valve embolisation (n = 9; 56.3%), followed by perforation of the left/right ventricle with guide wire/pacemaker lead (n = 3; 18.8%) and annular rupture (n = 3; 18.8%). Procedural, 30-day and 1­year mortality was 0%, 18.8% (n = 3) and 31.3% (n = 5), respectively. In-hospital stroke occurred in 1 patient (6.3%), a pacemaker was implanted at 30 days in 2 patients (12.5%), and major vascular complications did not occur. CONCLUSION: ECS following complicated TAVI was performed in only a small number of cases. It had a high but acceptable perioperative and 30-day mortality, taking into account the otherwise lethal consequences. In case of valve embolisation, no periprocedural or 30-day mortality was observed for surgical aortic valve replacement (even in a redo setting), which supported the necessity to perform TAVI in centres with cardiac surgical backup on site.