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Suture-Mediated Patent Foramen Ovale Closure Using the NobleStitch EL: Results from a Hospital-Based HTA

Author

Listed:
  • Giovanni Gaetti

    (School of Public Health, Vita-Salute San Raffaele University, 20132 Milan, Italy)

  • Alessandro Beneduce

    (Interventional Cardiology Unit, Cardio-Thoracic-Vascular Department, IRCCS San Raffaele Scientific Institute, 20132 Milan, Italy)

  • Dario La Fauci

    (HTA Committee, IRCCS San Raffaele Hospital, 20132 Milan, Italy)

  • Alessandro Scardoni

    (School of Public Health, Vita-Salute San Raffaele University, 20132 Milan, Italy)

  • Federica Chiappa

    (School of Public Health, Vita-Salute San Raffaele University, 20132 Milan, Italy)

  • Lorenzo Bellini

    (School of Public Health, Vita-Salute San Raffaele University, 20132 Milan, Italy)

  • Michela Franzin

    (HTA Committee, IRCCS San Raffaele Hospital, 20132 Milan, Italy)

  • Anna Maria Natale

    (HTA Committee, IRCCS San Raffaele Hospital, 20132 Milan, Italy)

  • Paola Marras

    (HTA Committee, IRCCS San Raffaele Hospital, 20132 Milan, Italy)

  • Paolo Ranieri

    (HTA Committee, IRCCS San Raffaele Hospital, 20132 Milan, Italy)

  • Carlo Signorelli

    (HTA Committee, IRCCS San Raffaele Hospital, 20132 Milan, Italy)

  • Eleonora Bossi

    (School of Public Health, Vita-Salute San Raffaele University, 20132 Milan, Italy)

  • Lucrezia Ferrario

    (Centre for Research on Health Economics, Social and Health Care Management, Carlo Cattaneo-LIUC University, 21053 Castellanza, Italy)

  • Emanuela Foglia

    (Centre for Research on Health Economics, Social and Health Care Management, Carlo Cattaneo-LIUC University, 21053 Castellanza, Italy)

  • Matteo Montorfano

    (Interventional Cardiology Unit, Cardio-Thoracic-Vascular Department, IRCCS San Raffaele Scientific Institute, 20132 Milan, Italy)

  • Anna Odone

    (HTA Committee, IRCCS San Raffaele Hospital, 20132 Milan, Italy
    Department of Public Health, Experimental and Forensic Medicine, University of Pavia, 27100 Pavia, Italy)

Abstract

(1) Background: Patent foramen ovale (PFO) is a congenital abnormality present in up to 25% of the general population, and it is a relevant cause of cryptogenic stroke. We applied the hospital-based HTA model (AdHopHTA) to conduct a multidimensional assessment of NobleStitch EL, an innovative suture-mediated PFO closure device. We compared it to Amplatzer PFO Occluder (APO) to provide evidence to inform technologies’ governance in hospital settings. (2) Methods: For each AdHopHTA dimension we: systematically retrieved available evidence from the literature applying the PRISMA guidelines and then analyzed original clinical and cost data of a NobleStitch EL device at San Raffaele research hospital in Milan (Italy). The economic dimension was analyzed through activity-based costing and a cost analysis. We conducted semi-structured interviews with selected healthcare professionals to explore the organizational, legal, social, and ethical impact. (3) Results: A single study was included for the NobleStitch EL, with 10 for APO. Both literature data and original data showed comparable safety. Efficacy data analysis found that the PFO closure was at 89% for NobleStitch EL vs. 89–97% for APO. APO has a better impact on the budget and minor process costs. Consulted experts reported that the organizational impact of NobleStitch EL in the short and the long run as null, albeit a better impact under the social and the ethical aspects. (4) Conclusion: We suggest that there is inadequate evidence to conclude the relative efficacy of NobleStitch EL as compared to APO. Nevertheless, this report shows a good safety profile and higher costs for NobleStitch EL, with no organizational or legal impact. Further studies in selected population are recommended.

Suggested Citation

  • Giovanni Gaetti & Alessandro Beneduce & Dario La Fauci & Alessandro Scardoni & Federica Chiappa & Lorenzo Bellini & Michela Franzin & Anna Maria Natale & Paola Marras & Paolo Ranieri & Carlo Signorell, 2022. "Suture-Mediated Patent Foramen Ovale Closure Using the NobleStitch EL: Results from a Hospital-Based HTA," IJERPH, MDPI, vol. 19(13), pages 1-14, June.
    • Handle: RePEc:gam:jijerp:v:19:y:2022:i:13:p:7863-:d:848657
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    References listed on IDEAS

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    1. David Moher & Alessandro Liberati & Jennifer Tetzlaff & Douglas G Altman & The PRISMA Group, 2009. "Preferred Reporting Items for Systematic Reviews and Meta-Analyses: The PRISMA Statement," PLOS Medicine, Public Library of Science, vol. 6(7), pages 1-6, July.
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