1. Acute and midterm outcomes of the post-approval MELODY Registry: a multicentre registry of transcatheter pulmonary valve implantation
- Author
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Nordmeyer, J., Ewert, P., Gewillig, M., AlJufan, M., Carminati, M., Kretschmar, O., Uebing, A., Dahnert, I., Rohle, R., Schneider, H., Witsenburg, M., Benson, L., Gitter, R., Bokenkamp, R., Mahadevan, V., Berger, F., Aggoun, Y., Agnoletti, G., Baumgartner, H., Lezo, J.S. de, Sofia, R., Dessy, H., Wolf, D. de, Dittrich, S., Dohlen, G., Emmel, M., Emmertsen, K., Fichtlscherer, S., Gabriel, H., Gaemperli, O., Gamillscheg, A., Godart, F., Guerin, P., Hofbeck, M., Marti, G., Michel-Behnke, I., Milanesi, O., Pinto, F., Qureshi, S., Schranz, D., Sievert, H., Sinisalo, J.P., Sluysmans, T., Spadoni, I., MELODY Registry Investigators, Pediatrics, University of Zurich, and Nordmeyer, Johannes
- Subjects
Adult ,Male ,medicine.medical_specialty ,Cardiac Catheterization ,Time Factors ,Heart disease ,Adolescent ,Heart Valve Diseases ,610 Medicine & health ,030204 cardiovascular system & hematology ,2705 Cardiology and Cardiovascular Medicine ,03 medical and health sciences ,Young Adult ,0302 clinical medicine ,Interquartile range ,Internal medicine ,medicine ,Humans ,Transcatheter pulmonary valve implantation ,030212 general & internal medicine ,Registries ,Child ,Retrospective Studies ,Congenital heart disease ,Heart Valve Prosthesis Implantation ,Pulmonary Valve ,Surrogate endpoint ,business.industry ,Hazard ratio ,RVOT dysfunction ,medicine.disease ,Confidence interval ,medicine.anatomical_structure ,Treatment Outcome ,Ventricle ,10036 Medical Clinic ,Infective endocarditis ,Cohort ,Cardiology ,Female ,Cardiology and Cardiovascular Medicine ,business ,Follow-Up Studies - 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 2 improved significantly from 36 [interquartile range (IQR) 24–47] to 12 (IQR 7–17) mmHg and 47 to 1%, respectively (P 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
- 2019