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Acute and midterm outcomes of the post-approval MELODY Registry : a multicentre registry of transcatheter pulmonary valve implantation

(2019) EUROPEAN HEART JOURNAL. 40(27). p.2255-2264
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Organization
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.
Keywords
ESC GUIDELINES, REPLACEMENT, MANAGEMENT, CONDUIT, RISK, REGURGITATION, Congenital heart disease, Transcatheter pulmonary valve implantation, RVOT dysfunction

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MLA
Nordmeyer, Johannes, et al. “Acute and Midterm Outcomes of the Post-Approval MELODY Registry : A Multicentre Registry of Transcatheter Pulmonary Valve Implantation.” EUROPEAN HEART JOURNAL, vol. 40, no. 27, 2019, pp. 2255–64.
APA
Nordmeyer, J., Ewert, P., Gewillig, M., Al Jufan, M., Carminati, M., Kretschmar, O., … Spadoni, I. (2019). Acute and midterm outcomes of the post-approval MELODY Registry : a multicentre registry of transcatheter pulmonary valve implantation. EUROPEAN HEART JOURNAL, 40(27), 2255–2264.
Chicago author-date
Nordmeyer, Johannes, Peter Ewert, Marc Gewillig, Mansour Al Jufan, Mario Carminati, Oliver Kretschmar, Anselm Uebing, et al. 2019. “Acute and Midterm Outcomes of the Post-Approval MELODY Registry : A Multicentre Registry of Transcatheter Pulmonary Valve Implantation.” EUROPEAN HEART JOURNAL 40 (27): 2255–64.
Chicago author-date (all authors)
Nordmeyer, Johannes, Peter Ewert, Marc Gewillig, Mansour Al Jufan, Mario Carminati, Oliver Kretschmar, Anselm Uebing, Ingo Daehnert, Robert Roehle, Heike Schneider, Maarten Witsenburg, Lee Benson, Roland Gitter, Regina Boekenkamp, Vaikom Mahadevan, Felix Berger, Yacine Aggoun, Gabriella Agnoletti, Helmut Baumgartner, Jose Suarez de Lezo, Reina Sofia, Hugues Dessy, Daniël De Wolf, Sven Dittrich, Gaute Dohlen, Mathias Emmel, Kristian Emmertsen, Stephan Fichtlscherer, Harald Gabriel, Oliver Gaemperli, Andreas Gamillscheg, Francois Godart, Patrice Guerin, Michael Hofbeck, Gerard Marti, Ina Michel-Behnke, Ornella Milanesi, Fatima Pinto, Shakeel Qureshi, Dietmar Schranz, Horst Sievert, Juha-Pekka Sinisalo, Thierry Sluysmans, and Isabella Spadoni. 2019. “Acute and Midterm Outcomes of the Post-Approval MELODY Registry : A Multicentre Registry of Transcatheter Pulmonary Valve Implantation.” EUROPEAN HEART JOURNAL 40 (27): 2255–2264.
Vancouver
1.
Nordmeyer J, Ewert P, Gewillig M, Al Jufan M, Carminati M, Kretschmar O, et al. Acute and midterm outcomes of the post-approval MELODY Registry : a multicentre registry of transcatheter pulmonary valve implantation. EUROPEAN HEART JOURNAL. 2019;40(27):2255–64.
IEEE
[1]
J. Nordmeyer et al., “Acute and midterm outcomes of the post-approval MELODY Registry : a multicentre registry of transcatheter pulmonary valve implantation,” EUROPEAN HEART JOURNAL, vol. 40, no. 27, pp. 2255–2264, 2019.
@article{8633653,
  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.},
  author       = {Nordmeyer, Johannes and Ewert, Peter and Gewillig, Marc and Al Jufan, Mansour and Carminati, Mario and Kretschmar, Oliver and Uebing, Anselm and Daehnert, Ingo and Roehle, Robert and Schneider, Heike and Witsenburg, Maarten and Benson, Lee and Gitter, Roland and Boekenkamp, Regina and Mahadevan, Vaikom and Berger, Felix and Aggoun, Yacine and Agnoletti, Gabriella and Baumgartner, Helmut and de Lezo, Jose Suarez and Sofia, Reina and Dessy, Hugues and De Wolf, Daniël and Dittrich, Sven and Dohlen, Gaute and Emmel, Mathias and Emmertsen, Kristian and Fichtlscherer, Stephan and Gabriel, Harald and Gaemperli, Oliver and Gamillscheg, Andreas and Godart, Francois and Guerin, Patrice and Hofbeck, Michael and Marti, Gerard and Michel-Behnke, Ina and Milanesi, Ornella and Pinto, Fatima and Qureshi, Shakeel and Schranz, Dietmar and Sievert, Horst and Sinisalo, Juha-Pekka and Sluysmans, Thierry and Spadoni, Isabella},
  issn         = {0195-668X},
  journal      = {EUROPEAN HEART JOURNAL},
  keywords     = {ESC GUIDELINES,REPLACEMENT,MANAGEMENT,CONDUIT,RISK,REGURGITATION,Congenital heart disease,Transcatheter pulmonary valve implantation,RVOT dysfunction},
  language     = {eng},
  number       = {27},
  pages        = {2255--2264},
  title        = {Acute and midterm outcomes of the post-approval MELODY Registry : a multicentre registry of transcatheter pulmonary valve implantation},
  url          = {http://dx.doi.org/10.1093/eurheartj/ehz201},
  volume       = {40},
  year         = {2019},
}

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