Cost-effectiveness of percutaneous patent foramen ovale closure as secondary stroke prevention

Abstract

Objective: Compared to medical therapy alone, percutaneous closure of patent foramen ovale (PFO) further reduces risk of recurrent ischemic strokes in carefully selected young to middle-aged patients with a recent cryptogenic ischemic stroke. The objective of this study was to evaluate the cost-effectiveness of this therapy in the context of the United Kingdom (UK) healthcare system.

Methods: A Markov cohort model consisting of four health states (Stable after index stroke, Post-Minor Recurrent Stroke, Post-Moderate Recurrent Stroke, and Death) was developed to simulate the economic outcomes of device-based PFO closure compared to medical therapy. Recurrent stroke event rates were extracted from a randomized clinical trial (RESPECT) with a median of 5.9-year follow-up. Health utilities and costs were obtained from published sources. One-way and probabilistic sensitivity analyses (PSA) were performed to assess robustness. The model was discounted at 3.5% and reported in 2016 Pounds Sterling.

Results: Compared with medical therapy alone and using a willingness-to-pay (WTP) threshold of £20,000, PFO closure reached cost-effectiveness at 4.2 years. Cost-effectiveness ratios (ICERs) at 4, 10, and 20 years were ₤20,951, ₤6,887, and ₤2,158, respectively. PFO closure was cost-effective for 89% of PSA iterations at year 10. Sensitivity analyses showed that the model was robust.

Conclusions: Considering the UK healthcare system perspective, percutaneous PFO closure in cryptogenic ischemic stroke patients is a cost-effective stroke prevention strategy compared to medical therapy alone. Its cost-effectiveness was driven by substantial reduction in recurrent strokes and patients’ improved health-related quality-of-life.

Keywords:

• Cost-effectiveness
• patent foramen ovale
• cryptogenic stroke
• recurrent stroke
• ischemic stroke
• percutaneous device closure
• Markov model

JEL classification codes:

• D61, I13

Transparency

Declaration of funding

This manuscript was funded by Abbott.

Declaration of financial/other relationships

DT has worked as a Neurology Executive member and a consultant on educational issues and has received contracted hourly payments from Abbott. MT has worked as a consultant on education and procedure proctoring and has received contracted hourly payments from Abbott. DT, DM, JC, LM, RS, and JLS have worked as Trial Steering Committee members, advising on rigorous trial design and conduct, and have received contracted hourly payments from Abbott. MK and NYG are employees of Abbott, Inc. Peer reviewers on this manuscript have received an honorarium from JME for their review work, but have no other relevant financial relationships to disclose.

Acknowledgments

The authors thank Louise Anderson, PhD FSA, Principle Health Economist at Technomics Research for invaluable assistance with economic modeling and editing of the manuscript.