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Published on: December 11, 2017
A prospective 5-year study of exercise performance following Melody valve implant
Bryant Priromprintr1, Michael J Silka2, Jonathan Rhodes3
1Children's Hospital Los Angeles, University of Southern California, Los Angeles, CA; Lucile Packard Children's Hospital at Stanford, Stanford University Medical Center, Palo Alto, CA.
Insights
The Melody valve implant offers initial exercise capacity gains in congenital heart disease patients, but long-term benefits are limited to specific subgroups, particularly younger patients with pulmonary regurgitation.
Area of Science:
- Cardiology
- Pediatric Cardiology
- Cardiovascular Surgery
Background:
- The long-term impact of Melody valve implantation on exercise capacity in patients with right ventricular outflow tract issues remains unclear.
- Congenital heart disease often necessitates interventions like the Melody valve to address conduit obstruction or insufficiency.
Purpose of the Study:
- To evaluate the sustained, long-term effects of Melody valve implantation on exercise capacity in patients with congenital heart disease.
- To identify patient subgroups that may experience enduring benefits from the Melody valve regarding exercise performance.
Main Methods:
- A prospective study involving 136 patients with congenital heart disease undergoing Melody valve implantation.
- Serial cardiopulmonary exercise testing was performed pre-implant, at 6 months, and annually for up to 5 years post-implantation.
- Subgroup analyses were conducted to identify factors associated with sustained exercise improvements.
Main Results:
- An initial improvement in predicted workload was observed at 6 months post-implantation, but this was not sustained at 5 years for the overall cohort.
- Patients younger than 17 years at implantation and those with pulmonary regurgitation as the primary lesion showed sustained exercise performance improvements.
- Sustained improvements in ventilatory equivalents for O2 and CO2 at the anaerobic threshold were noted, alongside initial but not sustained gains in forced vital capacity.
Conclusions:
- While the Melody valve may offer initial exercise capacity benefits and improved pulmonary function, sustained improvements are not evident in the general patient population.
- The study highlights the importance of patient-specific factors, such as age and primary lesion, in determining long-term exercise outcomes after Melody valve implantation.
- Further cautious appraisal of the cardiovascular benefits is warranted, with a focus on identifying specific patient profiles that benefit long-term.
Background:
The long-term benefits of Melody valve implant for right ventricular outflow tract conduit obstruction or insufficiency on exercise capacity are undefined.
Methods:
As part of the Melody valve clinical trial, 136 patients with congenital heart disease underwent serial cardiopulmonary exercise testing prior to, 6 months after, and annually for up to 5 years postimplant.
Results:
Mean age at Melody valve implantation was 22.4 ± 0.9 years (range 7-53 years). The 95 patients who completed the study protocol provide the basis of this report. An initial improvement in % predicted workload was present at 6 months postimplant; however, at the final (5 year) follow-up, sustained or further improvements in workload were not demonstrated for the entire cohort compared to baseline. By subgroup analysis, age <17 years at implant and pulmonary regurgitation as the primary lesion were variables associated with sustained improvement in exercise performance. There were sustained improvements in the ventilatory equivalents for O2 (minute ventilation/O2 intake, P = .01) and CO2 (minute ventilation/CO2 output, P < .01) at the ventilatory anaerobic threshold at the study conclusion. Improvements in forced vital capacity were also observed during the study but not sustained at the final follow-up.
Conclusions:
A cautious appraisal of the cardiovascular benefits of Melody valve implant on sustained improvements in exercise performance appears warranted. Although the observed changes in pulmonary function suggest improved restrictive lung physiology and more efficient gas exchange, after an initial increase in % predicted performance, neither sustained nor further improvements in exercise performance were observed, except in specific patient subgroups.
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