The European TauroPace™ Registry
Background: Cardiac implantable electronic device (CIED) placement comes with certain complications. CIED infection is a severe adverse event related to CIED placement. In randomised controlled trials, the preoperative intravenous administration of antibiotics and the adjunctive use of an antibiotic...
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| Format: | Article |
| Language: | English |
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MDPI AG
2023-09-01
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| Series: | Methods and Protocols |
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| Online Access: | https://www.mdpi.com/2409-9279/6/5/86 |
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| author | Reinhard Vonthein Benito Baldauf Stefan Borov Ernest W. Lau Marzia Giaccardi Roberto Cemin Ojan Assadian Philippe Chévalier Kerstin Bode Hendrik Bonnemeier |
| author_facet | Reinhard Vonthein Benito Baldauf Stefan Borov Ernest W. Lau Marzia Giaccardi Roberto Cemin Ojan Assadian Philippe Chévalier Kerstin Bode Hendrik Bonnemeier |
| author_sort | Reinhard Vonthein |
| collection | DOAJ |
| description | Background: Cardiac implantable electronic device (CIED) placement comes with certain complications. CIED infection is a severe adverse event related to CIED placement. In randomised controlled trials, the preoperative intravenous administration of antibiotics and the adjunctive use of an antibiotic mesh envelope resulted in significant reduction in infections related to cardiac implantable electronic devices. The adjunctive use of taurolidine for this purpose is relatively novel and not considered in the guidelines. The required evidence may consist of a set of clinical studies. Methods: The European TauroPace<sup>TM</sup> registry (ETPR) prospectively evaluates every consecutive invasive procedure involving any CIED with adjunct TauroPace™ use in the contributing centres. As the estimation of the infection rate needs to be defensible, only interventions registered prior to the procedure will be followed-up. The endpoint is a major cardiac implantable electronic device infection according to the novel CIED infection criteria (1). Secondary endpoints comprise all-cause mortality, complications, adverse events of all grades, and major CIED infections during all follow-up examinations. The follow-up times are three months, twelve months, and eventually 36 months, as acute, subacute, and long-term CIED infections are of interest. Results: As the rate of CIED infections is expected to be very low, this registry is a multicentre, international project that will run for several years. Several reports are planned. The analyses will be included in the case number calculations for future randomised controlled trials. Conclusions: The ETPR will accumulate large case numbers to estimate small event rates more precisely; we intend to follow up on participants for years to reveal possible late effects. |
| first_indexed | 2024-03-10T21:00:21Z |
| format | Article |
| id | doaj.art-1f4a5365c8fd4eac8a4a3a94e24a8ac6 |
| institution | Directory Open Access Journal |
| issn | 2409-9279 |
| language | English |
| last_indexed | 2024-03-10T21:00:21Z |
| publishDate | 2023-09-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Methods and Protocols |
| spelling | doaj.art-1f4a5365c8fd4eac8a4a3a94e24a8ac62023-11-19T17:34:58ZengMDPI AGMethods and Protocols2409-92792023-09-01658610.3390/mps6050086The European TauroPace™ RegistryReinhard Vonthein0Benito Baldauf1Stefan Borov2Ernest W. Lau3Marzia Giaccardi4Roberto Cemin5Ojan Assadian6Philippe Chévalier7Kerstin Bode8Hendrik Bonnemeier9Institut für Medizinische Biometrie und Statistik, Universität zu Lübeck, Ratzeburger Allee 160, 23562 Lübeck, GermanyInstitute of Life Science, Hochschule Bremerhaven, An der Karlstadt 8, 27568 Bremerhaven, GermanyMedical Faculty, Christian-Albrechts University, Christian-Albrechts-Platz 4, 24118 Kiel, GermanyDepartment of Cardiology, Royal Victoria Hospital, Grosvenor Road, Belfast BT12 6BA, UKDepartment of Cardiology, Ospedale Santa Maria Annunziata, Ponte a Niccheri, 50012 Florence, ItalyDepartment of Cardiology, Ospedale Regionale San Maurizio, Bolzano, Via Lorenz Böhler 5, 39100 Bolzano, ItalyRegional Hospital Wiener Neustadt, Wiener Neustadt 2700, AustriaDepartment of Cardiology, Hôpital Louis Pradel, 59 Bd Pinel, 69500 Bron, FranceDepartment of Electropyhsiology, Herzzentrum Leipzig, Strümpellstraße 39, 04289 Leipzig, GermanyInstitute of Life Science, Hochschule Bremerhaven, An der Karlstadt 8, 27568 Bremerhaven, GermanyBackground: Cardiac implantable electronic device (CIED) placement comes with certain complications. CIED infection is a severe adverse event related to CIED placement. In randomised controlled trials, the preoperative intravenous administration of antibiotics and the adjunctive use of an antibiotic mesh envelope resulted in significant reduction in infections related to cardiac implantable electronic devices. The adjunctive use of taurolidine for this purpose is relatively novel and not considered in the guidelines. The required evidence may consist of a set of clinical studies. Methods: The European TauroPace<sup>TM</sup> registry (ETPR) prospectively evaluates every consecutive invasive procedure involving any CIED with adjunct TauroPace™ use in the contributing centres. As the estimation of the infection rate needs to be defensible, only interventions registered prior to the procedure will be followed-up. The endpoint is a major cardiac implantable electronic device infection according to the novel CIED infection criteria (1). Secondary endpoints comprise all-cause mortality, complications, adverse events of all grades, and major CIED infections during all follow-up examinations. The follow-up times are three months, twelve months, and eventually 36 months, as acute, subacute, and long-term CIED infections are of interest. Results: As the rate of CIED infections is expected to be very low, this registry is a multicentre, international project that will run for several years. Several reports are planned. The analyses will be included in the case number calculations for future randomised controlled trials. Conclusions: The ETPR will accumulate large case numbers to estimate small event rates more precisely; we intend to follow up on participants for years to reveal possible late effects.https://www.mdpi.com/2409-9279/6/5/86taurolidinecardiac implantable electronic deviceinfection |
| spellingShingle | Reinhard Vonthein Benito Baldauf Stefan Borov Ernest W. Lau Marzia Giaccardi Roberto Cemin Ojan Assadian Philippe Chévalier Kerstin Bode Hendrik Bonnemeier The European TauroPace™ Registry Methods and Protocols taurolidine cardiac implantable electronic device infection |
| title | The European TauroPace™ Registry |
| title_full | The European TauroPace™ Registry |
| title_fullStr | The European TauroPace™ Registry |
| title_full_unstemmed | The European TauroPace™ Registry |
| title_short | The European TauroPace™ Registry |
| title_sort | european tauropace™ registry |
| topic | taurolidine cardiac implantable electronic device infection |
| url | https://www.mdpi.com/2409-9279/6/5/86 |
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