Percutaneous mitral repair as treatment in HFrEF (MitraClip/TEER) Cost-Effectiveness

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Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Nehal Eid, M.D.[2]

Cost-Effectiveness

Economic evidence for transcatheter edge-to-edge repair (TEER) in heart failure with reduced ejection fraction and secondary mitral regurgitation is derived predominantly from COAPT-based analyses comparing TEER plus guideline-directed medical therapy (GDMT) with GDMT alone. The results are model-based, payer-specific, and dependent on patient selection, device cost, hospitalization reduction, and assumptions regarding long-term survival.

Costs and hospitalization offsets

  • In the US COAPT analysis, the TEER device cost approximately $35,755 and the total index-hospitalization cost was $48,198. During 2 years of follow-up, medical costs were lower with TEER than with GDMT alone ($26,654 vs. $38,345; p=0.018), primarily because of fewer heart-failure hospitalizations.[1]
  • From the UK National Health Service perspective, the index-hospitalization cost was £18,781; the £16,218 device cost accounted for 86% of this amount.[2]
  • In the US and UK analyses, device cost represented approximately 74% and 86% of the respective index-hospitalization costs. Although subsequent hospitalization savings partially offset the procedure, cumulative costs remained higher with TEER over the initial 2-year period.[1][2] Cost figures from Baron et al. are reported in 2018 US dollars; those from Cohen et al. use 2019–2020 UK pounds sterling.
  • A prospective German real-world process-cost analysis reported total in-hospital costs of approximately €25,414–€25,633 for the MitraClip and PASCAL systems, with device cost remaining the principal cost driver.[3]

Cost-effectiveness estimates

Perspective and evidence base Modelled incremental outcomes Incremental cost Incremental cost-effectiveness ratio Interpretation
United States; COAPT-based lifetime model 1.13 life-years and 0.82 QALYs $45,648 $40,361 per life-year gained; $55,600 per QALY Below the commonly applied US willingness-to-pay range of $100,000–$150,000 per QALY.[1]
UK National Health Service; COAPT-based model 1.57 life-years and 1.12 QALYs £21,980 £23,270 per QALY; £12,494 per QALY if the observed trial benefit was assumed to persist without attenuation The primary estimate lies within the commonly applied £20,000–£30,000-per-QALY range.[2]
Euro-denominated model using 2-year COAPT data Model-dependent Not separately reported Approximately €21,918 per QALY The early estimate was more favorable than estimates incorporating later follow-up.[4]
Euro-denominated models using 3- and 5-year COAPT data Model-dependent Not separately reported Approximately €31,227–€38,123 per QALY using 3-year data; €35,068 per QALY using 5-year data The 5-year model estimated an 85% probability of cost-effectiveness at a €50,000-per-QALY threshold.[4][5]

Clinical interpretation

  • TEER was cost-effective at the specified willingness-to-pay thresholds in the COAPT-based US, UK, and euro-denominated models, but these findings do not establish economic value in every patient with secondary mitral regurgitation.
  • Favorable estimates apply principally to carefully selected, COAPT-like patients who remained symptomatic despite optimized GDMT. Extrapolation to patients with less severe mitral regurgitation, inadequate GDMT optimization, very advanced ventricular disease, or a low probability of procedural success is uncertain.[1][2]
  • Reduced heart-failure hospitalization is the principal observed cost offset. Longer follow-up permits these savings to accumulate, but analyses incorporating 3- and 5-year data produced less favorable incremental cost-effectiveness ratios than the initial 2-year analysis because the projected survival advantage attenuated.[4][5]
  • The COAPT 5-year follow-up showed that most of the mortality and heart-failure hospitalization benefit accrued during the first 2–3 years, providing clinical context for the less favorable cost-effectiveness estimates obtained when later follow-up was incorporated.[6]
  • Cost-effectiveness is sensitive to device pricing, local hospitalization costs, procedural complications, durability of mitral-regurgitation reduction, and the survival model used for lifetime extrapolation.[1][2][5]

Evidence limitations

  • The economic findings are primarily trial-based projections rather than direct lifetime observations.
  • The available RESHAPE-HF2 publication provides clinical outcomes but not a formal cost-effectiveness analysis; applying COAPT-derived estimates to its broader, generally lower-severity mitral-regurgitation population is uncertain.[7]
  • No head-to-head economic comparison between TEER and surgical mitral-valve intervention was identified in the cited analyses.
  • The 2022 AHA/ACC/HFSA guideline-associated economic review cautioned that the discordant results of COAPT and MITRA-FR create persistent uncertainty regarding the overall value of TEER and make firm conclusions from COAPT-based economic analyses difficult.[8]
  • Real-world value may differ from trial-based estimates because of variation in patient selection, procedural success, complication rates, GDMT optimization, device pricing, and healthcare-system costs.

References

  1. ↑ 1.0 1.1 1.2 1.3 1.4 Baron SJ, Wang K, Arnold SV; et al. (2019). "Cost-Effectiveness of Transcatheter Mitral Valve Repair Versus Medical Therapy in Patients With Heart Failure and Secondary Mitral Regurgitation: Results From the COAPT Trial". Circulation. 140 (23): 1881–1891. doi:10.1161/CIRCULATIONAHA.119.043275.
  2. ↑ 2.0 2.1 2.2 2.3 2.4 Cohen DJ, Wang K, Magnuson E; et al. (2022). "Cost-Effectiveness of Transcatheter Edge-to-Edge Repair in Secondary Mitral Regurgitation". Heart. 108 (9): 717–724. doi:10.1136/heartjnl-2021-320005.
  3. ↑ Haurand JM, Haschemi J, Oehler D; et al. (2023). "Comparison of Costs Associated With Transcatheter Mitral Valve Repair: PASCAL vs MitraClip in a Real-World Setting". BMC Health Services Research. 23 (1): 945. doi:10.1186/s12913-023-09966-8.
  4. ↑ 4.0 4.1 4.2 Connock M, Auguste P, Obadia JF, Andronis L, Armoiry X (2023). "Impact of Updated Trial Data on the Cost-Effectiveness of Percutaneous Mitral Repair". PLOS One. 18 (1): e0280554. doi:10.1371/journal.pone.0280554.
  5. ↑ 5.0 5.1 5.2 Connock M, Auguste P, Obadia JF, Armoiry X (2024). "Cost-Effectiveness of Percutaneous Mitral Repair for Patients With Severe Secondary Mitral Regurgitation: An Updated Evaluation Using a Modelling Approach Based on COAPT Final Data After 5-Year Follow-Up". BMJ Open. 14 (12): e087695. doi:10.1136/bmjopen-2024-087695.
  6. ↑ Stone GW, Abraham WT, Lindenfeld J; et al. (2023). "Five-Year Follow-up after Transcatheter Repair of Secondary Mitral Regurgitation". The New England Journal of Medicine. 388 (22): 2037–2048. doi:10.1056/NEJMoa2300213.
  7. ↑ Anker SD, Friede T, von Bardeleben RS; et al. (2024). "Transcatheter Valve Repair in Heart Failure with Moderate to Severe Mitral Regurgitation". The New England Journal of Medicine. 391 (19): 1799–1809. doi:10.1056/NEJMoa2314328.
  8. ↑ Heidenreich PA, Fonarow GC, Opsha Y; et al. (2022). "Economic Issues in Heart Failure in the United States". Journal of Cardiac Failure. 28 (3): 453–466. doi:10.1016/j.cardfail.2021.12.017.
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