Study Suggests PFO Closure May Be Cost-Effective Over Long Term

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While patent foramen ovale (PFO) closure is more expensive than medical therapy in patients with cryptogenic stroke in the short term, the discrepancy appears to decrease over time, according to a modeling study published online August 27, 2014, ahead of print in the American Journal of Cardiology. As such, PFO may be most cost-effective in younger patients, researchers suggest.

At 2.6 years, the per-patient cost for PFO closure ($19,364.97) was higher than for medical therapy alone ($3,152.23), primarily because of the increased procedural costs associated with closure. The expenditure to prevent 1 adverse event (TIA, stroke, or death) over that follow-up duration was $1,085,334 with closure.

Medicine and outcome costs were higher in the medical therapy group, but complication and procedural costs were higher with PFO closure. When costs were extrapolated to 5 years, PFO closure was still more expensive (table 1). Between 2.6 and 5 years, annual costs related to major bleeding were lower with closure while those related to A-fib were higher.

Table 1. Cost per Patient

PFO closure reached the incremental cost-effectiveness threshold of < $50,000 per quality-adjusted life-year (QALY) gained in 2.6 years. Moreover, the treatment met the threshold of < $50,000 per life-year gained in 4.9 years. The per-patient mean cost of medical therapy surpassed that of PFO closure after 30.2 years of follow-up.

In a subanalysis of PFO closure patients only implanted with the Amplatzer device (St. Jude; St. Paul, MN), medical therapy costs exceeded closure costs 8 years earlier than in the general cohort (22.1 years), and the time to achieve the cost-effectiveness threshold for QALY gained was quicker (2.38 years).

Public Health Implications Most Important

“This study demonstrates the potential public health costs associated with PFO closure and the time required to reach commonly accepted thresholds of cost-effectiveness,” Dr. Pickett and colleagues write. “Furthermore, the data from RCTs suggests that the cost-effectiveness of the Amplatzer device is achieved sooner due to a higher clinical efficacy related to this specific closure device type.”

The authors reference the PC and RESPECT trials, which demonstrated a growing advantage to PFO closure despite lower than expected event rates. “Thus it is possible that with longer follow-up, the cost-effectiveness of PFO closure will grow as more events are prevented,” they write.

A key point of the cost analysis that cannot be observed in a randomized trial, the authors continue, “is the debilitating individual patient-level, public health, and economic consequences of recurrent neurologic events…. This cost analysis demonstrates that PFO closure, in spite of its high initial cost, is cost-effective in the long term even without including these significant social and economic damages. Thus, it is probable that PFO closure is more cost-effective than depicted in our analysis.”

Some limitations, they note, include lack of crossover data, nonstandardized medical therapy, no accounting for lost time and productivity due to disability from adverse events, and absence of data on device erosion and embolization.

Source:
Pickett CA, Villines TC, Ferguson MA, et al. Cost effectiveness of percutaneous closure versus medical therapy for cryptogenic stroke in patients with a patent foramen ovale. Am J Cardiol. 2014;Epub ahead of print.

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