Acute and midterm outcomes of the post-approval MELODY Registry: a multicentre registry of transcatheter pulmonary valve implantation
Key result
After Melody TPVI, residual RV-to-PA gradient is linked to ~21% higher major event risk.
- 95% CI 3.7-4.9
- n=845
Why the study?
The study aimed to obtain multicentre registry data after transcatheter pulmonary valve implantation with the Melody valve in a large-scale cohort of patients with congenital heart disease.
Key Points
- To analyze multicentre registry data after transcatheter pulmonary valve implantation using the Melody™ valve in patients with congenital heart disease.
- Retrospective analysis of data from 42 centres following 845 patients who underwent TPVI from December 2006 to September 2013.
- Patients were followed up for a median of 5.9 years to assess TPVI-related events.
- Multivariable Cox proportional hazard models were used to evaluate risk factors associated with outcomes.
- The composite endpoint of TPVI-related events showed an incidence rate of 4.2% per person per year (95% CI 3.7-4.9).
- The risk of TPVI infective endocarditis had an adjusted hazard ratio of 1.19 (95% CI 1.07-1.32; P = 0.002).
- Significant improvements were noted in RV-to-PA pressure gradient from 36 mmHg to 12 mmHg (P < 0.001) and pulmonary regurgitation grade >2 from 47% to 1% (P < 0.001).
Study Design
Type
Cohort (n=845)
Multicenter
Yes
Structured PICO
P
Population
845 patients (mean age 21.0 years) with congenital heart disease who underwent transcatheter pulmonary valve implantation with the Melody valve, followed for a median of 5.9 years.
E
Exposure
Transcatheter pulmonary valve implantation (TPVI) with the Melody valve
O
Outcome
Composite endpoint of TPVI-related events during follow-up (death, reoperation, or reintervention >48 h after TPVI)composite
TPVI with the Melody valve is effective in CHD patients, though residual RV-to-PA pressure gradient increases the risk of adverse events and infective endocarditis remains a significant concern.
Key expert perspectives
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
“The positive results garnered in this real-world setting mirror those seen in other studies of the Melody valve. The one-year results show strong performance of the valve, which is intended to delay the time until open-heart surgery is needed. Decreasing the number of open-heart surgeries that our patients need has a significant impact on their lives and quality of life.”
“One of the celebratory aspects of this is that [Melody] represents a new paradigm in heart treatment that now has [grown into] this exploding number of patients treated worldwide, especially for aortic valve disease. But it all began with the congenital heart population in treating the pulmonary valve position.”
“There's always been sort of an understanding of how our individual patients are doing. But certainly in the aggregate to have this data and have it be the entirety of all the initial 171 patients who were enrolled 10 years down the line, it's very helpful.”
Implication
TPVI event rates support enhanced post-procedural surveillance in practice; observational data leaves open optimal valve selection and follow-up strategies.
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.
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Cite This Study
Nordmeyer et al. (2019) conducted a cohort in congenital heart disease (CHD) (n=845). Transcatheter pulmonary valve implantation (TPVI) with the Melody valve was evaluated on Composite of TPVI-related events during follow-up (death, reoperation, or reintervention >48 h after TPVI) (95% CI 3.7-4.9). Transcatheter pulmonary valve implantation with the Melody valve had a composite event incidence of 4.2% per person-year, with residual RV-to-PA gradient increasing this risk (HR 1.21; P<0.0001).