{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,27]],"date-time":"2026-05-27T13:07:44Z","timestamp":1779887264930,"version":"3.53.1"},"reference-count":35,"publisher":"The Journal of Health Economics and Outcomes Research","issue":"1","license":[{"start":{"date-parts":[[2026,1,26]],"date-time":"2026-01-26T00:00:00Z","timestamp":1769385600000},"content-version":"unspecified","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0"}],"content-domain":{"domain":["jheor.org"],"crossmark-restriction":true},"short-container-title":[],"abstract":"<jats:sec id=\"background\">\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Infections represent the most serious complication associated with cardiac implantable electronic devices (CIEDs). This can result in prolonged hospital stays, high morbidity and mortality, and a significant economic burden for healthcare systems.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"objectives\">\n                    <jats:title>Objectives<\/jats:title>\n                    <jats:p>This study aimed to evaluate the cost-effectiveness of the TYRX absorbable antibacterial envelope for CIED infection prevention from the Spanish Healthcare System perspective.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"methods\">\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>A decision tree model with a lifetime horizon was developed to compare standard antibiotic prophylaxis with its combination with TYRX, regardless of infection risk. The model incorporated infection incidence, mortality, and utility values up to 36 months, derived from REINFORCE, AdaptResponse, and WRAP-IT studies. Unit costs (2025 euros) included prevention strategies and infection management. Lifetime costs and quality-adjusted life-years (QALYs) were assigned to survivors beyond 36 months. The incremental cost-effectiveness ratio (ICER) was reported by CIED and weighted by implant distribution (permanent pacemaker [PPM, 76.5%], implantable cardioverter-defibrillator [ICD, 15.2%], cardiac resynchronization therapy with defibrillator [CRT-D, 5.4%], and pacemaker [CRT-P, 2.9%]). A subgroup analysis was performed in high-risk patients (PADIT\u22657), modifying infection rates based on PADIT risk stratification, along with sensitivity analyses. Model inputs were validated by an expert panel.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"results\">\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>TYRX was the dominant strategy (more effective and less costly) for CRT-D and ICD recipients and cost-effective for those receiving PPM (\u20ac17\u2009740\/QALY) or CRT-P (\u20ac14\u2009647\/QALY), considering a willingness-to-pay threshold of \u20ac25\u2009000\/QALY. Across the spectrum of CIEDs, the ICER was \u20ac11\u2009709\/QALY. TYRX remained cost-effective in 77% of sensitivity analysis simulations. In high-risk patients, TYRX was dominant for all CIEDs.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"discussion\">\n                    <jats:title>Discussion<\/jats:title>\n                    <jats:p>This study is believed to be the first economic evaluation of TYRX in Spain and provides novel evidence in a broad, unselected population. Previous cost-effectiveness analyses conducted across different healthcare systems have consistently shown that TYRX is cost-effective in patients at elevated risk for device-related infections. Although the populations and healthcare settings differ, our findings are consistent with this body of evidence.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"conclusions\">\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>TYRX represents a dominant strategy for infection prevention for CRT-D and ICD and is cost-effective for PPM and CRT-P, based on Spain\u2019s willingness to pay.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.36469\/001c.154974","type":"journal-article","created":{"date-parts":[[2026,1,26]],"date-time":"2026-01-26T15:23:19Z","timestamp":1769440999000},"update-policy":"https:\/\/doi.org\/10.36469\/00001","source":"Crossref","is-referenced-by-count":0,"title":["Cost-Effectiveness of an Absorbable Antibacterial Envelope for Infection Control in Cardiac Implantable Electronic Device Procedures in Spain"],"prefix":"10.36469","volume":"13","author":[{"given":"Tom\u00e1s","family":"Datino","sequence":"first","affiliation":[{"name":"Quir\u00f3nsalud Madrid and Ruber Juan Bravo University Hospitals, Universidad Europea de Madrid, Faculty of Biomedical and Health Sciences, Madrid, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daniela","family":"Afonso","sequence":"additional","affiliation":[{"name":"York Health Economics Consortium, York, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elana","family":"Greaves","sequence":"additional","affiliation":[{"name":"York Health Economics Consortium York, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Simon","family":"Eggington","sequence":"additional","affiliation":[{"name":"Medtronic International Trading S\u00e0rl, Tolochenaz, Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Julen","family":"Monge","sequence":"additional","affiliation":[{"name":"Medtronic Ib\u00e9rica, Madrid, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maria","family":"\u00c1lvarez Orozco","sequence":"additional","affiliation":[{"name":"Medtronic Ib\u00e9rica, Madrid, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Claudia","family":"Wolff","sequence":"additional","affiliation":[{"name":"Medtronic International Trading S\u00e0rl, Tolochenaz, Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stuart","family":"Mealing","sequence":"additional","affiliation":[{"name":"York Health Economics Consortium, York, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ar\u00edstides","family":"de Alarc\u00f3n","sequence":"additional","affiliation":[{"name":"Virgen del Roc\u00edo University Hospital, Seville, Spain","department":["Clinical Unit of Infectious Diseases, Microbiology, and Parasitology"]}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"22273","published-online":{"date-parts":[[2026,1,26]]},"reference":[{"issue":"10","key":"ref1","doi-asserted-by":"publisher","first-page":"1158","DOI":"10.1016\/j.jacep.2017.02.016","article-title":"Antibacterial envelope is associated with low infection rates after implantable cardioverter-defibrillator and cardiac resynchronization therapy device replacement: results of the Citadel and Centurion Studies","volume":"3","author":"C. 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Molina-Lerma","year":"2023","journal-title":"Rev Esp Cardiol (Engl Ed)"},{"issue":"4","key":"ref8","doi-asserted-by":"publisher","first-page":"746","DOI":"10.1002\/hec.3633","article-title":"Estimating a cost-effectiveness threshold for the Spanish NHS","volume":"27","author":"L. Vallejo-Torres","year":"2018","journal-title":"Health Econ"},{"issue":"1","key":"ref9","doi-asserted-by":"publisher","first-page":"1000","DOI":"10.1186\/s12913-020-05825-y","article-title":"How to assess the value of low-value care","volume":"20","author":"J. A. Sacrist\u00e1n","year":"2020","journal-title":"BMC Health Serv Res"},{"key":"ref10","doi-asserted-by":"publisher","first-page":"1147","DOI":"10.1016\/S0140-6736(23)00912-1","article-title":"Adaptive versus conventional cardiac resynchronisation therapy in patients with heart failure (AdaptResponse): a global, prospective, randomised controlled trial","volume":"30","author":"B. L. Wilkoff","year":"2023","journal-title":"Lancet"},{"issue":"7","key":"ref11","doi-asserted-by":"publisher","first-page":"930","DOI":"10.1016\/j.jval.2020.12.021","article-title":"Cost-effectiveness analyses of an absorbable antibacterial envelope for use in patients at increased risk of cardiac implantable device infection in Germany, Italy and England","volume":"24","author":"G. Boriani","year":"2021","journal-title":"Value Health"},{"issue":"1","key":"ref12","doi-asserted-by":"publisher","first-page":"e0206611","DOI":"10.1371\/journal.pone.0206611","article-title":"Cardiac implantable electronic device (CIED) infections are expensive and associated with prolonged hospitalisation: UK Retrospective Observational Study","volume":"14","author":"F. Z. Ahmed","year":"2019","journal-title":"PLoS ONE"},{"issue":"8","key":"ref13","doi-asserted-by":"publisher","first-page":"604","DOI":"10.7326\/0003-4819-133-8-200010170-00011","article-title":"Diagnosis and management of infections involving implantable electrophysiologic cardiac devices","volume":"133","author":"J. D. Chua","year":"2000","journal-title":"Ann Intern Med"},{"issue":"6","key":"ref14","doi-asserted-by":"publisher","first-page":"1482","DOI":"10.1016\/j.jtcvs.2010.11.059","article-title":"Complete removal as a routine treatment for any cardiovascular implantable electronic device associated infection","volume":"142","author":"M. Pichlmaier","year":"2011","journal-title":"J Thorac Cardiovasc Surg"},{"key":"ref15","article-title":"Data on file","author":"Medtronic"},{"key":"ref16","article-title":"BOT PLUS: base de datos de medicamentos y productos de parafarmacia","author":"Consejo General de Colegios Farmac\u00e9uticos","journal-title":"Consejo General de Colegios Oficiales de Farmac\u00e9uticos (CGCOF)"},{"issue":"suppl S1","key":"ref17","doi-asserted-by":"publisher","first-page":"i180","DOI":"10.1093\/europace\/euy015.525","article-title":"Economic impact associated with complications of cardiac implantable electronic devices in Spain","volume":"20","author":"M. Egea","year":"2018","journal-title":"Session Europace 2018"},{"key":"ref18","article-title":"Base de datos de costes sanitarios y ratios coste-efectividad espa\u00f1oles: eSalud","author":"R. Gisbert","journal-title":"Oblikue Consulting, S.L."},{"key":"ref19","article-title":"Chaleco desfibrilador externo LifeVest\u00ae para la prevenci\u00f3n del paro card\u00edaco s\u00fabito","author":"M. C. Maceira-Rozas","year":"2018"},{"key":"ref20","article-title":"Implantable cardioverter defibrillators and cardiac resynchronisation therapy for arrhythmias and heart failure [TA314]","author":"National Institute for Health and Care Excellence (NICE)","year":"2014"},{"key":"ref21","article-title":"Currency converter","author":"Xe"},{"issue":"10","key":"ref22","doi-asserted-by":"publisher","first-page":"1001","DOI":"10.1016\/j.jacc.2011.04.033","article-title":"16-year trends in the infection burden for pacemakers and implantable cardioverter-defibrillators in the United States 1993 to 2008","volume":"58","author":"A. J. Greenspon","year":"2011","journal-title":"J Am Coll Cardiol"},{"key":"ref23","article-title":"Gu\u00eda de Evaluaci\u00f3n Econ\u00f3mica de Medicamentos","author":"Comit\u00e9 Asesor para la Financiaci\u00f3n de la prestaci\u00f3n Farmac\u00e9utica del Sistema Nacional de Salud"},{"key":"ref24","doi-asserted-by":"publisher","first-page":"1419","DOI":"10.1007\/s10840-024-01759-1","article-title":"Device infection in patients undergoing pacemaker or defibrillator surgery: risk stratification using the PADIT score","volume":"67","author":"J. de Heide","year":"2024","journal-title":"J Interv Card Electrophysiol"},{"issue":"35","key":"ref25","doi-asserted-by":"publisher","first-page":"3427","DOI":"10.1093\/eurheartj\/ehab364","article-title":"2021 ESC Guidelines on Cardiac Pacing and Cardiac Resynchronization Therapy: developed by the Task Force on Cardiac Pacing and Cardiac Resynchronization Therapy of the European Society of Cardiology (ESC) with the special contribution of the European Heart Rhythm Association (EHRA)","volume":"42","author":"M. Glikson","year":"2021","journal-title":"Eur Heart J"},{"issue":"10","key":"ref26","doi-asserted-by":"publisher","first-page":"e008503","DOI":"10.1161\/CIRCEP.120.008503","article-title":"Cost-effectiveness of an antibacterial envelope for cardiac implantable electronic device infection prevention in the US healthcare system from the WRAP-IT Trial","volume":"13","author":"B. L. Wilkoff","year":"2020","journal-title":"Circ Arrhythm Electrophysiol"},{"issue":"5","key":"ref27","doi-asserted-by":"publisher","first-page":"767","DOI":"10.1093\/europace\/euaa291","article-title":"Economic evaluation of an absorbable antibiotic envelope for prevention of cardiac implantable electronic device infection","volume":"23","author":"E. 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Prutkin","year":"2014","journal-title":"Circulation"},{"issue":"1","key":"ref30","doi-asserted-by":"publisher","first-page":"91","DOI":"10.3390\/jpm12010091","article-title":"Incidence and predictors of infections and all-cause death in patients with cardiac implantable electronic devices: the Italian Nationwide RI-AIAC Registry","volume":"12","author":"G. Boriani","year":"2022","journal-title":"J Pers Med"},{"issue":"3","key":"ref31","doi-asserted-by":"publisher","first-page":"537","DOI":"10.3390\/microorganisms12030537","article-title":"Mortality and costs of cardiac implantable electronic device (CIED) infections according to the therapeutic approach: a single-center cohort study","volume":"12","author":"E. Guti\u00e9rrez-Carretero","year":"2024","journal-title":"Microorganisms"},{"issue":"1","key":"ref32","doi-asserted-by":"publisher","first-page":"29","DOI":"10.1161\/CIRCEP.108.795906","article-title":"Efficacy of antibiotic prophylaxis before the implantation of pacemakers and cardioverter-defibrillators: results of a large, prospective, randomized, double-blinded placebo-controlled trial","volume":"2","author":"J. C. de Oliveira","year":"2009","journal-title":"Circ Arrhythm Electrophysiol"},{"issue":"24","key":"ref33","doi-asserted-by":"publisher","first-page":"3098","DOI":"10.1016\/j.jacc.2018.09.068","article-title":"Prevention of arrhythmia device infection trial: the PADIT trial","volume":"72","author":"A. D. Krahn","year":"2018","journal-title":"J Am Coll Cardiol"},{"issue":"23","key":"ref34","doi-asserted-by":"publisher","first-page":"1862","DOI":"10.1093\/eurheartj\/ehz316","article-title":"Incidence of device-related infection in 97 750 patients: clinical data from the complete Danish device-cohort (1982-2018)","volume":"40","author":"T. Olsen","year":"2019","journal-title":"Eur Heart J"},{"issue":"4","key":"ref35","doi-asserted-by":"publisher","first-page":"515","DOI":"10.1093\/europace\/euz246","article-title":"European Heart Rhythm Association (EHRA) international consensus document on how to prevent, diagnose, and treat cardiac implantable electronic device infections-endorsed by the Heart Rhythm Society (HRS), the Asia Pacific Heart Rhythm Society (APHRS), the Latin American Heart Rhythm Society (LAHRS), International Society for Cardiovascular Infectious Diseases (ISCVID) and the European Society of Clinical Microbiology and Infectious Diseases (ESCMID) in collaboration with the European Association for Cardio-Thoracic Surgery (EACTS)","volume":"22","author":"C. 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