Cardiac magnetic resonance imaging versus computed tomography to guide transcatheter aortic valve replacement: study protocol for a randomized trial (TAVR-CMR)
Abstract Background The standard procedure for the planning of transcatheter aortic valve replacement (TAVR) is the combination of echocardiography, coronary angiography, and cardiovascular computed tomography (TAVR-CT) for the exact determination of the aortic valve dimensions, valve size, and impl...
| Main Authors: | , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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BMC
2022-09-01
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| Series: | Trials |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s13063-022-06638-6 |
| _version_ | 1817986722035662848 |
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| author | Gert Klug Sebastian Reinstadler Felix Troger Magdalena Holzknecht Martin Reindl Christina Tiller Ivan Lechner Priscilla Fink Mathias Pamminger Christian Kremser Hanno Ulmer Axel Bauer Bernhard Metzler Agnes Mayr |
| author_facet | Gert Klug Sebastian Reinstadler Felix Troger Magdalena Holzknecht Martin Reindl Christina Tiller Ivan Lechner Priscilla Fink Mathias Pamminger Christian Kremser Hanno Ulmer Axel Bauer Bernhard Metzler Agnes Mayr |
| author_sort | Gert Klug |
| collection | DOAJ |
| description | Abstract Background The standard procedure for the planning of transcatheter aortic valve replacement (TAVR) is the combination of echocardiography, coronary angiography, and cardiovascular computed tomography (TAVR-CT) for the exact determination of the aortic valve dimensions, valve size, and implantation route. However, up to 80% of the patients undergoing TAVR suffer from chronic renal insufficiency. Alternatives to reduce the need for iodinated contrast agents are desirable. Cardiac magnetic resonance (CMR) imaging recently has emerged as such an alternative. Therefore, we aim to investigate, for the first time, the non-inferiority of TAVR-CMR to TAVR-CT regarding efficacy and safety end-points. Methods This is a prospective, randomized, open-label trial. It is planned to include 250 patients with symptomatic severe aortic stenosis scheduled for TAVR based on a local heart-team decision. Patients will be randomized in a 1:1 fashion to receive a predefined TAVR-CMR protocol or to receive a standard TAVR-CT protocol within 2 weeks after inclusion. Follow-up will be performed at hospital discharge after TAVR and after 1 and 2 years. The primary efficacy outcome is device implantation success at discharge. The secondary endpoints are a combined safety endpoint and a combined clinical efficacy endpoint at baseline and at 1 and 2 years, as well as a comparison of imaging procedure related variables. Endpoint definitions are based on the updated 2012 VARC-2 consensus document. Discussion TAVR-CMR might be an alternative to TAVR-CT for planning a TAVR procedure. If proven to be effective and safe, a broader application of TAVR-CMR might reduce the incidence of acute kidney injury after TAVR and thus improve outcomes. Trial registration The trial is registered at ClinicalTrials.gov (NCT03831087). The results will be disseminated at scientific meetings and publication in peer-reviewed journals. |
| first_indexed | 2024-04-14T00:13:00Z |
| format | Article |
| id | doaj.art-35f21b5260c043908ac075021023518b |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-04-14T00:13:00Z |
| publishDate | 2022-09-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-35f21b5260c043908ac075021023518b2022-12-22T02:23:15ZengBMCTrials1745-62152022-09-0123111110.1186/s13063-022-06638-6Cardiac magnetic resonance imaging versus computed tomography to guide transcatheter aortic valve replacement: study protocol for a randomized trial (TAVR-CMR)Gert Klug0Sebastian Reinstadler1Felix Troger2Magdalena Holzknecht3Martin Reindl4Christina Tiller5Ivan Lechner6Priscilla Fink7Mathias Pamminger8Christian Kremser9Hanno Ulmer10Axel Bauer11Bernhard Metzler12Agnes Mayr13University Clinic of Internal Medicine III, Cardiology and Angiology, Medical University of InnsbruckUniversity Clinic of Internal Medicine III, Cardiology and Angiology, Medical University of InnsbruckUniversity Clinic of Internal Medicine III, Cardiology and Angiology, Medical University of InnsbruckUniversity Clinic of Internal Medicine III, Cardiology and Angiology, Medical University of InnsbruckUniversity Clinic of Internal Medicine III, Cardiology and Angiology, Medical University of InnsbruckUniversity Clinic of Internal Medicine III, Cardiology and Angiology, Medical University of InnsbruckUniversity Clinic of Internal Medicine III, Cardiology and Angiology, Medical University of InnsbruckUniversity Clinic of Internal Medicine III, Cardiology and Angiology, Medical University of InnsbruckUniversity Clinic of Radiology, Medical University of InnsbruckUniversity Clinic of Radiology, Medical University of InnsbruckDepartment for Medical Statistics, Informatics and Health Economy, Medical University of InnsbruckUniversity Clinic of Internal Medicine III, Cardiology and Angiology, Medical University of InnsbruckUniversity Clinic of Internal Medicine III, Cardiology and Angiology, Medical University of InnsbruckUniversity Clinic of Radiology, Medical University of InnsbruckAbstract Background The standard procedure for the planning of transcatheter aortic valve replacement (TAVR) is the combination of echocardiography, coronary angiography, and cardiovascular computed tomography (TAVR-CT) for the exact determination of the aortic valve dimensions, valve size, and implantation route. However, up to 80% of the patients undergoing TAVR suffer from chronic renal insufficiency. Alternatives to reduce the need for iodinated contrast agents are desirable. Cardiac magnetic resonance (CMR) imaging recently has emerged as such an alternative. Therefore, we aim to investigate, for the first time, the non-inferiority of TAVR-CMR to TAVR-CT regarding efficacy and safety end-points. Methods This is a prospective, randomized, open-label trial. It is planned to include 250 patients with symptomatic severe aortic stenosis scheduled for TAVR based on a local heart-team decision. Patients will be randomized in a 1:1 fashion to receive a predefined TAVR-CMR protocol or to receive a standard TAVR-CT protocol within 2 weeks after inclusion. Follow-up will be performed at hospital discharge after TAVR and after 1 and 2 years. The primary efficacy outcome is device implantation success at discharge. The secondary endpoints are a combined safety endpoint and a combined clinical efficacy endpoint at baseline and at 1 and 2 years, as well as a comparison of imaging procedure related variables. Endpoint definitions are based on the updated 2012 VARC-2 consensus document. Discussion TAVR-CMR might be an alternative to TAVR-CT for planning a TAVR procedure. If proven to be effective and safe, a broader application of TAVR-CMR might reduce the incidence of acute kidney injury after TAVR and thus improve outcomes. Trial registration The trial is registered at ClinicalTrials.gov (NCT03831087). The results will be disseminated at scientific meetings and publication in peer-reviewed journals.https://doi.org/10.1186/s13063-022-06638-6Transcatheter aortic valve replacementCardiac magnetic resonanceComputed tomographyKidney injury |
| spellingShingle | Gert Klug Sebastian Reinstadler Felix Troger Magdalena Holzknecht Martin Reindl Christina Tiller Ivan Lechner Priscilla Fink Mathias Pamminger Christian Kremser Hanno Ulmer Axel Bauer Bernhard Metzler Agnes Mayr Cardiac magnetic resonance imaging versus computed tomography to guide transcatheter aortic valve replacement: study protocol for a randomized trial (TAVR-CMR) Trials Transcatheter aortic valve replacement Cardiac magnetic resonance Computed tomography Kidney injury |
| title | Cardiac magnetic resonance imaging versus computed tomography to guide transcatheter aortic valve replacement: study protocol for a randomized trial (TAVR-CMR) |
| title_full | Cardiac magnetic resonance imaging versus computed tomography to guide transcatheter aortic valve replacement: study protocol for a randomized trial (TAVR-CMR) |
| title_fullStr | Cardiac magnetic resonance imaging versus computed tomography to guide transcatheter aortic valve replacement: study protocol for a randomized trial (TAVR-CMR) |
| title_full_unstemmed | Cardiac magnetic resonance imaging versus computed tomography to guide transcatheter aortic valve replacement: study protocol for a randomized trial (TAVR-CMR) |
| title_short | Cardiac magnetic resonance imaging versus computed tomography to guide transcatheter aortic valve replacement: study protocol for a randomized trial (TAVR-CMR) |
| title_sort | cardiac magnetic resonance imaging versus computed tomography to guide transcatheter aortic valve replacement study protocol for a randomized trial tavr cmr |
| topic | Transcatheter aortic valve replacement Cardiac magnetic resonance Computed tomography Kidney injury |
| url | https://doi.org/10.1186/s13063-022-06638-6 |
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