Nordmeyer, Johannes, Ewert, Peter, Gewillig, Marc, AlJufan, Mansour, Carminati, Mario ORCID: 0000-0001-9734-3007, Kretschmar, Oliver, Uebing, Anselm ORCID: 0000-0001-8504-0228, Daehnert, Ingo, Roehle, Robert, Schneider, Heike, Witsenburg, Maarten, Benson, Lee, Gitter, Roland, Boekenkamp, Regina, Mahadevan, Vaikom, Berger, Felix, Aggoun, Yacine, Agnoletti, Gabriella, Baumgartner, Helmut, de Lezo, Jose Suarez, Sofia, Reina, Dessy, Hugues, De Wolf, Daniel, Dittrich, Sven ORCID: 0000-0002-8455-3416, Dohlen, Gaute, Emmel, Mathias, Emmertsen, Kristian, Fichtlscherer, Stephan, Gabriel, Harald, Gaemperli, Oliver, Gamillscheg, Andreas, Godart, Francois, Guerin, Patrice, Hofbeck, Michael, Marti, Gerard, Michel-Behnke, Ina, Milanesi, Ornella, Pinto, Fatima, Qureshi, Shakeel, Schranz, Dietmar, Sievert, Horst, Sinisalo, Juha-Pekka, Sluysmans, Thierry and Spadoni, Isabella (2019). Acute and midterm outcomes of the post-approval MELODY Registry: a multicentre registry of transcatheter pulmonary valve implantation. Eur. Heart J., 40 (27). S. 2255 - 2265. OXFORD: OXFORD UNIV PRESS. ISSN 1522-9645

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Abstract

Aims The post-approval MELODY Registry aimed to obtain multicentre registry data after transcatheter pulmonary valve implantation (TPVI) with the Melody (TM) valve (Medtronic plc.) in a large-scale cohort of patients with congenital heart disease (CHD). Methods and results Retrospective analysis of multicentre registry data after TPVI with the Melody (TM) valve. Eight hundred and forty-five patients (mean age: 21.0 +/- 11.1 years) underwent TPVI in 42 centres between December 2006 and September 2013 and were followed-up for a median of 5.9 years (range: 0-11.0 years). The composite endpoint of TPVI-related events during follow-up (i.e. death, reoperation, or reintervention >48 h after TPVI) showed an incidence rate of 4.2% per person per year [95% confidence interval (CI) 3.7-4.9]. Transcatheter pulmonary valve implantation infective endocarditis (I.E.) showed an incidence rate of 2.3% per person per year (95% CI 1.9-2.8) and resulted in significant morbidity and in nine deaths. In multivariable Cox proportional hazard models, the invasively measured residual right ventricle (RV)-to-pulmonary artery (PA) pressure gradient (per 5 mmHg) was associated with the risk of the composite endpoint (adjusted hazard ratio: 1.21, 95% CI 1.12-1.30; P<0.0001) and the risk of TPVI I.E. (adjusted hazard ratio: 1.19, 95% CI 1.07-1.32; P=0.002). Major procedural complications (death, surgical, or interventional treatment requirement) occurred in 0.5%, 1.2%, and 2.0%, respectively. Acutely, the RV-to-PA pressure gradient and the percentage of patients with pulmonary regurgitation grade >2 improved significantly from 36 [interquartile range (IQR) 24-47] to 12 (IQR 7-17) mmHg and 47 to 1%, respectively (P < 0.001 for each). Conclusion The post-approval MELODY Registry confirms the efficacy of TPVI with the Melody (TM) valve in a large-scale cohort of CHD patients. The residual invasively measured RV-to-PA pressure gradient may serve as a target for further improvement in the composite endpoint and TPVI I.E. However, TPVI I.E. remains a significant concern causing significant morbidity and mortality.

Item Type: Journal Article
Creators:
CreatorsEmailORCIDORCID Put Code
Nordmeyer, JohannesUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Ewert, PeterUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Gewillig, MarcUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
AlJufan, MansourUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Carminati, MarioUNSPECIFIEDorcid.org/0000-0001-9734-3007UNSPECIFIED
Kretschmar, OliverUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Uebing, AnselmUNSPECIFIEDorcid.org/0000-0001-8504-0228UNSPECIFIED
Daehnert, IngoUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Roehle, RobertUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Schneider, HeikeUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Witsenburg, MaartenUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Benson, LeeUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Gitter, RolandUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Boekenkamp, ReginaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Mahadevan, VaikomUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Berger, FelixUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Aggoun, YacineUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Agnoletti, GabriellaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Baumgartner, HelmutUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
de Lezo, Jose SuarezUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Sofia, ReinaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Dessy, HuguesUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
De Wolf, DanielUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Dittrich, SvenUNSPECIFIEDorcid.org/0000-0002-8455-3416UNSPECIFIED
Dohlen, GauteUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Emmel, MathiasUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Emmertsen, KristianUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Fichtlscherer, StephanUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Gabriel, HaraldUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Gaemperli, OliverUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Gamillscheg, AndreasUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Godart, FrancoisUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Guerin, PatriceUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Hofbeck, MichaelUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Marti, GerardUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Michel-Behnke, InaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Milanesi, OrnellaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Pinto, FatimaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Qureshi, ShakeelUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Schranz, DietmarUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Sievert, HorstUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Sinisalo, Juha-PekkaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Sluysmans, ThierryUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Spadoni, IsabellaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
URN: urn:nbn:de:hbz:38-135174
DOI: 10.1093/eurheartj/ehz201
Journal or Publication Title: Eur. Heart J.
Volume: 40
Number: 27
Page Range: S. 2255 - 2265
Date: 2019
Publisher: OXFORD UNIV PRESS
Place of Publication: OXFORD
ISSN: 1522-9645
Language: English
Faculty: Unspecified
Divisions: Unspecified
Subjects: no entry
Uncontrolled Keywords:
KeywordsLanguage
ESC GUIDELINES; REPLACEMENT; MANAGEMENT; CONDUIT; RISK; REGURGITATIONMultiple languages
Cardiac & Cardiovascular SystemsMultiple languages
Refereed: Yes
URI: http://kups.ub.uni-koeln.de/id/eprint/13517

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