Cost-effectiveness and budget impact of PFO closure: Cardioform vs Amplatzer and medical therapy for secondary stroke prevention in Australia

Abstract

The objective of this study was to evaluate the value of three secondary stroke prevention strategies in Australia: the Cardioform and Amplatzer Patent Foramen Ovale (PFO) closure devices, and medical management. An eight-state Markov model was employed to simulate a cohort of 1,000 patients with a history of PFO-associated stroke over a five-year time horizon. Treatment strategies included Cardioform, Amplatzer, and medical therapy alone. Effectiveness data were derived from the REDUCE and RESPECT trials, a matching-adjusted indirect comparison (MAIC), and prior cost-effectiveness studies. Costs, presented from an Australian healthcare perspective and expressed in 2023 AUD, were used to calculate quality-adjusted life-years (QALYs), strokes prevented, the incremental cost-effectiveness ratio (ICER), and net monetary benefit (NMB). Compared to Amplatzer, treatment with Cardioform yielded cost savings to the Australian health care systems (NMB of AUD 3.7 million) and improved patient outcomes (yielded 26.48 additional QALYs and prevented 28 more recurrent strokes). Relative to medical therapy alone, Cardioform resulted in improved patient outcomes and was cost-effective, with an ICER of $11,784/QALY. Cardioform provides an NMB of AUD 14.3 million and yielded 374.5 additional QALYs beside preventing 67 more strokes compared to medical therapy alone. Cardioform appears more cost-effective in the prevention of secondary PFO-associated strokes, supporting its adoption in clinical practice.