Clinical and Hemodynamic Outcomes up to 7 Years After Transcatheter Pulmonary Valve Replacement in the US Melody Valve Investigational Device Exemption Trial

Abstract

Background-Studies of transcatheter pulmonary valve (TPV) replacement with the Melody valve have demonstrated goodshort-term outcomes, but there are no published long-term follow-up data. Methods and Results-The US Investigational Device Exemption trial prospectively enrolled 171 pediatric and adult patients (median age, 19 years) with right ventricular outflow tract conduit obstruction or regurgitation. The 148 patients who received and were discharged with a TPV were followed up annually according to a standardized protocol. During a median follow-up of 4.5 years (range, 0.4-7 years), 32 patients underwent right ventricular outflow tract reintervention for obstruction (n=27, with stent fracture in 22), endocarditis (n=3, 2 with stenosis and 1 with pulmonary regurgitation), or right ventricular dysfunction (n=2). Eleven patients had the TPV explanted as an initial or second reintervention. Five-year freedom from reintervention and explantation was 76±4% and 92±3%, respectively. A conduit prestent and lower discharge right ventricular outflow tract gradient were associated with longer freedom from reintervention. In the 113 patients who were alive and reintervention free, the follow-up gradient (median, 4.5 years after implantation) was unchanged from early post-TPV replacement, and all but 1 patient had mild or less pulmonary regurgitation. Almost all patients were in New York Heart Association class I or II. More severely impaired baseline spirometry was associated with a lower likelihood of improvement in exercise function after TPV replacement. Conclusions-TPV replacement with the Melody valve provided good hemodynamic and clinical outcomes up to 7 years after implantation. Primary valve failure was rare. The main cause of TPV dysfunction was stenosis related to stent fracture, which was uncommon once prestenting became more widely adopted. Clinical Trial Registration-URL: http://www.clinicaltrials.gov. Unique identifier: NCT00740870. (Circulation.

Infective Endocarditis After Melody Valve Implantation in the Pulmonary Position: A Systematic Review

“…Clinical trials have shown the safety and efficacy of TPVI, with excellent short‐term outcomes2 and freedom from reintervention in most patients up to 5 years 3. However, the risk of IE of the Melody valve is increasingly recognized as a significant threat to the long‐term valve function.…”

“…In the initial phase of TPVI experience, reobstruction of the RVOT with subsequent reintervention was relatively common, and it was mostly attributable to stent fracture 3. In the more contemporary TPVI experience, with the adoption of routine prestenting, reintervention attributable to recurrent valve obstruction became uncommon 4, 24, 61, 62.…”

“…TPVI was subsequently shown to provide satisfactory hemodynamic and clinical outcomes and a low rate of primary valve dysfunction, especially with the marked reduction in the rates of stent fracture after the wide adoption of routine prestenting 3, 4. However, valve dysfunction secondary to infective endocarditis (IE) is increasingly recognized as a threat to valve function and patients’ outcomes3, 5 after TPVI.…”

“…However, valve dysfunction secondary to infective endocarditis (IE) is increasingly recognized as a threat to valve function and patients’ outcomes3, 5 after TPVI. This risk of IE should be kept in mind when considering the expansion of the indications of TPVI to patients with native RVOT and small/large pulmonary conduits,6 and as a valve‐in‐valve treatment 7…”

Outcomes Following Melody Transcatheter Pulmonary Valve Implantation for Right Ventricular Outflow Tract Dysfunction in Repaired Congenital Heart Disease: First Reported Australian Single Centre Experience

“…Transcatheter pulmonary valve implantation (TPVI) with the Melody® transcatheter pulmonary valve (TPV) (Medtronic Inc, Minneapolis, United States) has demonstrated good haemodynamic and clinical outcomes in the treatment of RVOT conduit dysfunction in patients with repaired CHD (2,3). Numerous trial and registry data have demonstrated reduced RVOT gradients, elimination of pulmonary regurgitation or stenosis and good clinical outcomes early after implantation (4)(5)(6)(7).…”