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Transcatheter valve may be effective for failed bioprosthetic pulmonary valves
A preliminary multicenter study found that a transcatheter valve implant is an effective treatment option for patients with failed bioprosthetic valves.
Researchers reviewed the off-label use of transcatheter pulmonary valve implantation of the Melody valve (Medtronic) in the pulmonary position within bioprosthetic valves from eight centers in the United States that enrolled 104 patients from April 2007 to January 2012.
Ten types of bioprosthetic valves received the Melody valve implantation, with all placements at the intended site in all patients. There were no procedural morbidities or deaths related to the catheterization or implant.
After valve implant, the peak right ventricle-to-pulmonary artery gradient decreased from 38.7 ± 16.3 mm Hg to 10.9 ± 6.7 mm Hg (P<.001), and all but two patients had post-implant gradients less than 25 mm Hg. The right ventricular systolic pressure fell from 71.6 ± 21.7 mm Hg to 46.7 ± 15.9 mm Hg, and the RV diastolic pressure decreased from 11.9 ± 4.6 mm Hg to 10.4 ± 3.7 mm Hg (both P<.001).
No patients had more than mild regurgitation, whereas four had a mean RV outflow tract gradient ≥30 mm Hg at a median follow-up of 12 months. During follow-up, there were two stent fractures, three cases of endocarditis (two managed with surgical explant) and two deaths unrelated to the Melody valve.
Researchers said the procedure had a high success rate, low procedure-related morbidity and mortality and excellent short-term results, including a low rate of stent fracture.
“This remarkable success rate, with low procedural morbidity, supports the feasibility and safety of [transcatheter pulmonary valve implantation] using the Melody valve in a variety of different anatomies and surgical prostheses,” they wrote.
Disclosure: All of the researchers are consultants for Medtronic and act as investigators or proctors.