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

Giovanni Gaetti, Alessandro Beneduce, Dario La Fauci, Alessandro Scardoni, Federica Chiappa, Lorenzo Bellini, Michela Franzin, Anna Maria Natale, Paola Marras, Paolo Ranieri, Carlo Signorelli, Eleonora Bossi, Lucrezia Ferrario, Emanuela Foglia, Matteo Montorfano and Anna Odone
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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

IJERPH, 2022, vol. 19, issue 13, 1-14

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.

Keywords: Health Technology Assessment; AdHopHTA; hospital-based HTA; PFO; systematic review (search for similar items in EconPapers)
JEL-codes: I I1 I3 Q Q5 (search for similar items in EconPapers)
Date: 2022
References: View references in EconPapers View complete reference list from CitEc
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