Johannes Nordmeyer1, Peter Ewert2,3,4, Marc Gewillig5, Mansour AlJufan6, Mario Carminati7, Oliver Kretschmar8, Anselm Uebing9, Ingo Dähnert10, Robert Röhle11, Heike Schneider12, Maarten Witsenburg13, Lee Benson14, Roland Gitter15, Regina Bökenkamp16, Vaikom Mahadevan17, Felix Berger1,18,19. 1. Department of Congenital Heart Disease-Pediatric Cardiology, German Heart Institute Berlin, Augustenburger Platz 1, Berlin, Germany. 2. Department of Pediatric Cardiology and Congenital Heart Disease, German Heart Center Munich, Lazarettstraße 36, Munich, Germany. 3. TUM School of Medicine, Technical University of Munich, Ismaninger Straße 22, Munich, Germany. 4. Munich Heart Alliance, Partner Site of the DZHK (German Centre for Cardiovascular Research), Biedersteiner Str. 29, Munich, Germany. 5. Fetal and Pediatric Cardiology, University Hospitals Leuven, Herestraat 49, Leuven, Belgium. 6. King Faisal Specialist Hospital and Research Centre, Heart Centre, MBC-16, Riyadh, Kingdom of Saudi Arabia. 7. Department of Pediatric Cardiology and Adult Congenital Heart Disease, Via Morandi, 30, San Donato Milanese, Milan, Italy. 8. Department of Paediatric Cardiology, University Children's Hospital, Steinwiesstrasse 75, Zurich, Switzerland. 9. Adult Congenital Heart Disease Centre, Royal Brompton Hospital, Sydney Street, London, UK. 10. Department of Pediatric Cardiology, University of Leipzig - Heart Centre, Strümpellstr. 39, Leipzig, Germany. 11. Coordination Center of Clinical Studies, KKS, Charité University Medicine Berlin, Augustenburger Platz 1, Berlin, Germany. 12. Department of Pediatric Cardiology, University Medical Centre, Robert-Koch-Str. 40, Göttingen, Germany. 13. Department of Paediatric Cardiology, Erasmus University Medical Centre, Dr. Molewaterplein 40, GD Rotterdam, Netherlands. 14. Division of Cardiology, Department of Pediatrics, The Hospital for Sick Children, 555 University Ave, Toronto, Ontario, Canada. 15. Department of Pediatric Cardiology, Kepler University Hospital, Krankenhausstr. 9, Linz, Austria. 16. Department of Pediatric Cardiology, Leiden University Medical Centre, Albinusdreef 2, ZA Leiden, Netherlands. 17. Central Manchester University Hospitals, Manchester Royal Infirmary, Oxford Rd, Manchester, UK. 18. Division of Cardiology, Department of Pediatrics, Charité University Medicine Berlin, Augustenburger Platz 1, Berlin, Germany. 19. DZHK (German Centre for Cardiovascular Research), Partner Site Berlin, Augustenburger Platz 1, Berlin, Germany.
Abstract
AIMS: The post-approval MELODY Registry aimed to obtain multicentre registry data after transcatheter pulmonary valve implantation (TPVI) with the Melody™ 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™ 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™ 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. Published on behalf of the European Society of Cardiology. All rights reserved.
AIMS: The post-approval MELODY Registry aimed to obtain multicentre registry data after transcatheter pulmonary valve implantation (TPVI) with the Melody™ 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™ 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™ 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. Published on behalf of the European Society of Cardiology. All rights reserved.
Authors: Clara Stammnitz; Dörte Huscher; Ulrike M M Bauer; Aleksandra Urban; Johannes Nordmeyer; Stephan Schubert; Joachim Photiadis; Felix Berger; Sabine Klaassen Journal: J Am Heart Assoc Date: 2022-02-18 Impact factor: 5.501
Authors: Thomas K Jones; Doff B McElhinney; Julie A Vincent; William E Hellenbrand; John P Cheatham; Darren P Berman; Evan M Zahn; Danyal M Khan; John F Rhodes; Shicheng Weng; Lisa J Bergersen Journal: Circ Cardiovasc Interv Date: 2021-12-21 Impact factor: 6.546