Cost-effectiveness analysis of patent foramen ovale closure with Amplatzer plus medical therapy compared to medical therapy in patients with a history of stroke in France

Amel Allou; Louise Baschet; Charles Sabourin; Gilles Montalscot; Luc Lorgis; Xavier Iriart

doi:10.1016/j.jjcc.2021.10.009

Cost-effectiveness analysis of patent foramen ovale closure with Amplatzer plus medical therapy compared to medical therapy in patients with a history of stroke in France

J Cardiol. 2022 Jul;80(1):72-79. doi: 10.1016/j.jjcc.2021.10.009. Epub 2021 Nov 10.

Authors

Amel Allou¹, Louise Baschet², Charles Sabourin³, Gilles Montalscot⁴, Luc Lorgis⁵, Xavier Iriart⁶

Affiliations

¹ IQVIA, RWS, Paris, France. Electronic address: amel.allou@fr.imshealth.com.
² IQVIA, RWS, Paris, France.
³ ABBOTT, Paris, France.
⁴ Sorbonne University, ACTION Study Group, Pitié-Salpêtrière Hospital (AP-HP), Paris, France.
⁵ Department of Cardiology, University Hospital, Dijon, France; Laboratory of Cerebro-Vascular Pathophysiology and Epidemiology (PEC2) EA 7460, Dijon, France; University of Burgundy, Dijon, France.
⁶ Bordeaux University Hospital (CHU), Department of Pediatric and Adult Congenital Cardiology, Pessac, France; IHU Liryc, Electrophysiology and Heart Modeling Institute, Fondation Bordeaux Université, Pessac-Bordeaux, France; INSERM, Centre de recherche Cardio-Thoracique de Bordeaux, U1045, Bordeaux, France.

PMID: 34772575
DOI: 10.1016/j.jjcc.2021.10.009

Abstract

Background: A patent foramen ovale (PFO) is formed when the ovale foramen does not close spontaneously or re-opens leaving the right and left atrium connected. The present study was conducted to analyze the cost-effectiveness of PFO closure with Amplatzer device plus medical therapy (MT) compared to MT alone in the French reimbursement system for PFO patients with a prior history of stroke, using the RESPECT study data.

Methods: A multi-state Markov model was used. The analysis was conducted from a collective perspective over a 10-year time horizon with 4% discount applied for costs and health effects. The simulated population included adult patients with PFO. Sub-group analysis was limited to patients with atrial septal aneurysm and/or a large-shunt. Clinical inputs were derived from the RESPECT study and literature. Costs associated with the device, drugs, and management were sourced from literature and national databases. The outcomes of analyses included life-years (LYs), quality-adjusted LYs (QALYs), incremental cost-effectiveness ratio (ICER), and number of recurrent strokes avoided. Scenario and sensitivity analyses were conducted to assess the robustness of the results.

Results: The use of Amplatzer plus MT provided additional QALYs (0.16) at an incremental cost of 7301€, generating an ICER of 46,288€/QALY for Amplatzer vs. MT alone. In the sub-group analysis, Amplatzer plus MT provided additional QALYs (0.20) at an incremental cost of 5818€, generating an ICER of 28,624€/QALY for Amplatzer plus MT vs. MT alone. Amplatzer plus MT led to lower number of recurrent strokes in comparison to MT alone in both populations. Scenario and sensitivity analyses confirmed the robustness of the results.

Conclusion: Amplatzer plus MT represents a cost-effective treatment option and is associated with lower stroke recurrence compared to MT alone for PFO patients with a prior history of stroke.

Keywords: Cost-effectiveness analysis; Patent foramen ovale; Patent foramen ovale closure; Quality-adjusted life year; Stroke.

Publication types

Review
Research Support, Non-U.S. Gov't

MeSH terms

Adult
Cardiac Catheterization / methods
Cost-Benefit Analysis
Foramen Ovale, Patent* / complications
Foramen Ovale, Patent* / therapy
Humans
Quality-Adjusted Life Years
Recurrence
Secondary Prevention / methods
Septal Occluder Device*
Stroke* / etiology
Stroke* / prevention & control
Treatment Outcome