Evaluating cost-effectiveness of PFO management strategies: closure with cardioform vs. amplatzer, and treatment with medical therapy alone, for secondary stroke prevention.

ABSTRACT

AIM: The aim of this study was to evaluate the cost-effectiveness of patent foramen ovale (PFO) closure using CARDIOFORM Septal Occluders versus AMPLATZER Septal Occluders, as well as compared to Medical Therapy Alone, from a payor perspective in the United States. METHODS: An economic evaluation compared the value of CARDIOFORM, AMPLATZER, and Medical Therapy Alone. A Markov model simulated a cohort of 1,000 individuals with PFO and a history of cryptogenic stroke, with baseline demographic and clinical characteristics reflecting individuals enrolled in the REDUCE and RESPECT trials over a five-year time horizon. The costs and health consequences associated with complications and adverse events, including recurrent stroke, were compared over a time horizon of 5 years. RESULTS: PFO closure using CARDIOFORM was economically dominant, providing both cost-savings and improved effectiveness compared to closure with AMPLATZER. It resulted in an estimated savings of over $1.3 million, an additional 24.8 quality-adjusted life-years (QALYs) gained, and 26 strokes avoided in a cohort of 1,000 patients. When compared to Medical Therapy Alone, closure with CARDIOFORM was found to be cost-effective, with an incremental cost-effectiveness ratio (ICER) of $36,697 per QALY gained. Sensitivity and scenario analysis showed the model findings to be highly robust across reasonable changes to baseline input values and assumptions. CONCLUSIONS: The results of this analysis suggest that PFO closure using the CARDIOFORM Septal Occluder is the most cost-effective treatment strategy for patients with a PFO-associated stroke, particularly compared to AMPLATZER where it resulted in both cost-saving and improved patient outcomes.

Why was this study done? Patent foramen ovale (PFO) is a small opening in the heart that can allow blood clots to pass from one side to the other, increasing the risk of strokes, particularly those without a clear cause, known as cryptogenic strokes. Closing the PFO can help prevent these strokes. This study aimed to determine which treatment option is the best value for money and most effective for preventing secondary strokes in patients with PFO using the CARDIOFORM Septal Occluder, the AMPLATZER Septal Occluder, or using only medications.What did the researchers do? We used a computer model to simulate the health outcomes and costs for 1,000 patients with PFO who had experienced a cryptogenic stroke. The model followed these patients over five years and compared three treatment strategies closing the PFO with the CARDIOFORM device, closing it with the AMPLATZER device, and using medications alone (Medical Therapy Alone).What did the researchers find? Our findings showed thatThe CARDIOFORM device was more cost-effective and provided better health outcomes than the AMPLATZER device.Using the CARDIOFORM device saved over $1.3 million, added nearly 25 more years of good-quality life (measured as quality-adjusted life years or QALYs), and prevented 26 strokes in a group of 1,000 patients.Compared to using medications alone, the CARDIOFORM device was cost-effective, with a cost of about $36,700 for each year of good-quality life gained. What do the results mean? These results suggest that using the CARDIOFORM device to close a PFO is the best strategy for preventing secondary strokes when compared to AMPLATZER and Medical Therapy Alone. This approach not only saves money but also improves patient outcomes compared to the AMPLATZER device and using medications alone.How could this study help patients? This study provides clear and well-grounded information that helps patients, healthcare providers, and policymakers make informed decisions about the best treatment strategies for preventing secondary strokes in patients with PFO. Using the CARDIOFORM device can lead to better health outcomes and cost savings, ultimately improving the quality of life for patients.