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Melody TPV shows promising results in post-approval study
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WASHINGTON — The Melody Transcatheter Pulmonary Valve led to excellent hemodynamic function at 6 months, along with high rates of procedural success and freedom from device dysfunction at 1 year, according to a researcher of the post-approval study presented here.
“This study showed excellent procedural results and safety and outstanding valve function with the Melody Transcatheter Pulmonary Valve [TPV, Medtronic] throughout the entire first year following implantation,” Aimee K. Armstrong, MD, study investigator and associate professor of pediatrics at University of Michigan C.S. Mott Children’s Hospital Congenital Heart Center, Ann Arbor, told Cardiology Today’s Intervention. “It confirms the initial investigational device exemption [IDE] trial that was done more than 5 years ago.”
In the nonrandomized, prospective, 10-center, post-approval study, Armstrong and colleagues aimed to confirm that the short-term hemodynamic efficacy of the Melody TPV implanted by real-world providers is equivalent to the control established in the five-center IDE trial.
Aimee K. Armstrong
The researchers enrolled 120 patients and implanted the valve in 100 patients, with one excluded for surgical removal in the first 24 hours due to coronary compression. Patients had a stenotic and/or regurgitant right ventricle to pulmonary artery conduit of at least 16 mm at implantation. There was no age or weight limit. According to Armstrong, the mean age was 19.9 years, with the age of patients who underwent cardiac catheterization ranging from 5 to 45 years.
Follow-up was 22 ± 18.9 months.
Armstrong and colleagues reported a procedural success rate — defined as a peak cath gradient <35 mm Hg and no greater than mild regurgitation — of 98%.
At 6 months, researchers observed acceptable hemodynamic function in 96.7% of patients with evaluable data (lower confidence bound [LCB], 91.6%; P<.01) and 87.9% of the implanted cohort (LCB, 81.1%; P<.01), both above the performance goal of 75%. Results were maintained through 1 year (evaluable data patients, 94.3%; implanted cohort, 82.8%).
Right ventricular outflow tract mean gradient was reduced by more than half at 1 year (n=85) vs. baseline (n=97; 15.1 ± 7.1 mm Hg vs. 33.3 ± 14.1 mm Hg). Also at 1 year, 87.7% of patients had no or trace pulmonary regurgitation compared with 8.1% at baseline.
Additional 1-year data revealed 100% of patients were free from catheter reintervention, 98% were free from reoperation and 96.9% were free from TPV dysfunction.
Armstrong attributed the higher rate of freedom from TPV dysfunction in the post-approval study vs. the IDE study (96.9% vs. 93.5%) to a particular technique used by the operators.
“What we found was that if we pre-stent with another type of stent prior to putting in the Melody valve, we decreased the risk for fracture,” she said. “We did more pre-stenting in this post-approval study than in the IDE trial, and I think that is what led to the difference [in valve dysfunction].”
The Melody TPV received FDA approval with a humanitarian device exemption in 2010.
The valve is intended to delay time until surgery is needed and reduce the number of open-heart surgeries over a patient’s lifetime. The device is comprised of a bovine jugular vein valve on a platinum iridium frame and balloon-in-balloon catheter delivery system.
Researchers of the post-approval study plan to follow patients for 5 years. – by Brian Ellis
For more information:
Armstrong AK. Late-breaking clinical trials III. Presented at: American College of Cardiology Scientific Sessions; March 29-31, 2014; Washington, DC.
Disclosure: Armstrong’s institution received funding for the study from Medtronic.
Perspective
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Prediman K. Shah, MD, FACC
This procedure is a lifesaver for these kids who have to face the realities of multiple open-heart procedures. Even if they can avoid one or two open-heart procedures, or delay them for many years, this is a godsend for them. I think the results are spectacular and will likely get even better.Click Here to Manage Email Alerts