Cost-Effectiveness and Budget Impact of Cardioform versus Amplatzer and Medical Therapy Alone for Patent Foramen Ovale Closure: A UK Payer Perspective.

PURPOSE: This study evaluated the cost-effectiveness and budget impact of two patent foramen ovale (PFO) closure devices and medical management for the prevention of recurrent PFO-associated strokes in the UK. PATIENTS AND METHODS: We used a Markov model to simulate 1000 individuals with a history of PFO-associated stroke over a five-year time horizon. Treatment options included GORE® CARDIOFORM Septal Occluder (GSO Device), Amplatzer™ Talisman PFO Occluder (ATO Device), and Medical Therapy Alone. Effectiveness data were drawn from the REDUCE and RESPECT trials and prior cost-effectiveness analyses (CEAs). No head-to-head clinical trial comparing the ATO and GSO Device was identified; therefore, comparative clinical effectiveness estimates were derived from a matching-adjusted indirect comparison (MAIC). Costs were assessed from a UK payer perspective (2023 GBP). Outcomes included quality-adjusted life-years (QALYs), prevented strokes, incremental cost-effectiveness ratio (ICER), and budget impact. RESULTS: GSO Device was estimated to be cost-saving and generate 24.66 additional QALYs versus ATO Device (dominant ICER) over five years and in a cohort of 1000 patients. Compared with Medical Therapy Alone, it provided 406.66 additional QALYs at an ICER of £14,343/QALY. It also prevented 27.86 and 67.05 strokes versus ATO Device and Medical Therapy Alone, respectively. CONCLUSION: The use of GSO Device is a cost-effective option for the prevention of secondary PFO-associated strokes, with favorable estimated clinical outcomes. Future studies providing direct comparative evidence between GSO and ATO could further inform the relative clinical and cost-effectiveness of available PFO closure devices.