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September 5, 2026Journal of Medical EconomicsOpen Access

Cost-effectiveness analysis of Cardioform vs. Amplatzer: concerns regarding methodological transparency and interpretation of clinical results

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Comparison

Cardioform vs Amplatzer device for secondary prevention of PFO closure

Key result

Cost-effectiveness comparisons between Cardioform and Amplatzer devices for patent foramen ovale closure raise concerns regarding methodological transparency and interpretation of clinical results.

Authors

DHDavid W. HuttonARAnne M. RyschonSGScott Goates

Discussion

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Member takes

Overview

Clinicians should view PFO device cost-effectiveness claims cautiously; challenges prior analyses and leaves open need for transparent re-evaluation.

Key Points

  • To critically evaluate the methodological transparency, clinical assumptions, and interpretation of findings in a published cost-effectiveness analysis comparing Cardioform and Amplatzer devices for patent foramen ovale (PFO) closure.
  • Critique and methodological assessment of the economic evaluation model published by Volpi et al. comparing Cardioform versus Amplatzer PFO closure devices.
  • Analysis of data sources, clinical input parameters, and assumptions regarding secondary stroke prevention efficacy and device-related complication rates.
  • Identifies significant methodological limitations and lack of transparency in the original economic modeling framework.
  • Highlights potential biases in the clinical interpretation of comparative device outcomes and associated cost projections for PFO management.

Structured PICO

P
Population
Patients with patent foramen ovale (PFO) for secondary prevention
I
Intervention
PFO closure with Cardioform device
C
Comparator
PFO closure with Amplatzer device
O
Outcome
Cost-effectiveness

This article raises methodological concerns regarding a previously published cost-effectiveness analysis of Cardioform versus Amplatzer devices for PFO closure.

Cite This Study

Hutton et al. (2026) studied this question. Cost-effectiveness comparisons between Cardioform and Amplatzer devices for patent foramen ovale closure raise concerns regarding methodological transparency and interpretation of clinical results.

synapsesocial.com/papers/6a9bd3c76b95aff0620eaf73https://doi.org/10.1080/13696998.2026.2724710
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