User login
WASHINGTON - A transcatheter pulmonary valve system that provides a new right ventricle to pulmonary artery conduit to congenital heart disease patients without the need for open heart surgery performed a little better in a real-world registry at 10 U.S. centers than it had in the pivotal trial that led to the system's 2010 FDA approval.
The new results "confirm the strong performance of the Melody transcatheter pulmonary valve achieved by real-world providers with results comparable to the U.S. investigational device exemption [IDE] trial," Dr. Aimee K. Armstrong said at the annual meeting of the American College of Cardiology. The "high level" of 97% freedom from transcatheter pulmonary valve (TPV) dysfunction at 1 year "was better than in the IDE trial," where the level reached 94%, noted Dr. Armstrong of the University of Michigan in Ann Arbor.
The registry study, which the FDA mandated when it approved the Melody valve in 2010, ran during July 2010 to July 2012 at 10 U.S. centers that had not participated in the pivotal trial. The 99 patients who received an implant that stayed in place for at least 1 day ranged from 5 to 45 years old, with an average age of 20 years. Although patient follow-up averaged 22 months, the study's primary endpoint was acceptable hemodynamic function within the conduit at 6 months, with a prespecified performance goal of 75% of patients achieving this outcome. The outcome actually occurred in 97% of the 90 evaluable patients at 6 months, and in 88% of all 99 patients who received a conduit. The difference between each of these rates and the performance goal was statistically significant, Dr. Armstrong said.
The transcatheter valve showed excellent performance by other criteria as well. Acceptable hemodynamic function continued through 1 year in 94% of the 87 implanted patients with evaluable data at 12 months, which translated to 83% of the entire 99 patients in the implanted group. Severe or moderate pulmonary valve regurgitation existed in 85% of the patients before treatment; after treatment no patient had severe or moderate regurgitation, and after 1 year 63% had no regurgitation, 24% had trace, and 12% had mild regurgitation (figures total 99% because of rounding). The 1-year rate of 97% of patients free from dysfunction of their implanted valve appeared to surpass the 94% rate seen in the pivotal trial (Circulation 2010;122:507-16).
The results also showed that high right ventricular pressure prior to valve placement was the only variable independently associated with subsequent valve dysfunction. "Patients who go into the procedure with a very stenotic conduit are probably at higher risk for transcatheter pulmonary valve dysfunction down the road," she said.
The study was sponsored by Medtronic, which markets the Melody transcatheter pulmonary valve. Dr. Armstrong said she has received research funding from Medtronic and Edwards Lifesciences.
 |
| Dr. Robert Jaquiss |
This study is an important post-approval demonstration that the excellent early results obtained in the original IDE trial in the United States can be reproduced or even exceeded with a broader rollout of the Melody valve to many more centers. The next set of data, which is eagerly anticipated, is the mid-term and longer results for the Melody valve, which will begin to answer questions about the durability of valve competence. Additional information about the performance of the valve in alternative anatomic settings, such as in failing stented bioprostheses - so-called "valve-in-valve" usage - is also beginning to accumulate.
Dr. Robert Jaquiss is professor of surgery and pediatrics and chief of pediatric heart surgery at Duke University School of Medicine and an associate medical editor for Vascular Specialist.
| |
| Dr. Robert Jaquiss |
This study is an important post-approval demonstration that the excellent early results obtained in the original IDE trial in the United States can be reproduced or even exceeded with a broader rollout of the Melody valve to many more centers. The next set of data, which is eagerly anticipated, is the mid-term and longer results for the Melody valve, which will begin to answer questions about the durability of valve competence. Additional information about the performance of the valve in alternative anatomic settings, such as in failing stented bioprostheses - so-called "valve-in-valve" usage - is also beginning to accumulate.
Dr. Robert Jaquiss is professor of surgery and pediatrics and chief of pediatric heart surgery at Duke University School of Medicine and an associate medical editor for Vascular Specialist.
| |
| Dr. Robert Jaquiss |
This study is an important post-approval demonstration that the excellent early results obtained in the original IDE trial in the United States can be reproduced or even exceeded with a broader rollout of the Melody valve to many more centers. The next set of data, which is eagerly anticipated, is the mid-term and longer results for the Melody valve, which will begin to answer questions about the durability of valve competence. Additional information about the performance of the valve in alternative anatomic settings, such as in failing stented bioprostheses - so-called "valve-in-valve" usage - is also beginning to accumulate.
Dr. Robert Jaquiss is professor of surgery and pediatrics and chief of pediatric heart surgery at Duke University School of Medicine and an associate medical editor for Vascular Specialist.
WASHINGTON - A transcatheter pulmonary valve system that provides a new right ventricle to pulmonary artery conduit to congenital heart disease patients without the need for open heart surgery performed a little better in a real-world registry at 10 U.S. centers than it had in the pivotal trial that led to the system's 2010 FDA approval.
The new results "confirm the strong performance of the Melody transcatheter pulmonary valve achieved by real-world providers with results comparable to the U.S. investigational device exemption [IDE] trial," Dr. Aimee K. Armstrong said at the annual meeting of the American College of Cardiology. The "high level" of 97% freedom from transcatheter pulmonary valve (TPV) dysfunction at 1 year "was better than in the IDE trial," where the level reached 94%, noted Dr. Armstrong of the University of Michigan in Ann Arbor.
The registry study, which the FDA mandated when it approved the Melody valve in 2010, ran during July 2010 to July 2012 at 10 U.S. centers that had not participated in the pivotal trial. The 99 patients who received an implant that stayed in place for at least 1 day ranged from 5 to 45 years old, with an average age of 20 years. Although patient follow-up averaged 22 months, the study's primary endpoint was acceptable hemodynamic function within the conduit at 6 months, with a prespecified performance goal of 75% of patients achieving this outcome. The outcome actually occurred in 97% of the 90 evaluable patients at 6 months, and in 88% of all 99 patients who received a conduit. The difference between each of these rates and the performance goal was statistically significant, Dr. Armstrong said.
The transcatheter valve showed excellent performance by other criteria as well. Acceptable hemodynamic function continued through 1 year in 94% of the 87 implanted patients with evaluable data at 12 months, which translated to 83% of the entire 99 patients in the implanted group. Severe or moderate pulmonary valve regurgitation existed in 85% of the patients before treatment; after treatment no patient had severe or moderate regurgitation, and after 1 year 63% had no regurgitation, 24% had trace, and 12% had mild regurgitation (figures total 99% because of rounding). The 1-year rate of 97% of patients free from dysfunction of their implanted valve appeared to surpass the 94% rate seen in the pivotal trial (Circulation 2010;122:507-16).
The results also showed that high right ventricular pressure prior to valve placement was the only variable independently associated with subsequent valve dysfunction. "Patients who go into the procedure with a very stenotic conduit are probably at higher risk for transcatheter pulmonary valve dysfunction down the road," she said.
The study was sponsored by Medtronic, which markets the Melody transcatheter pulmonary valve. Dr. Armstrong said she has received research funding from Medtronic and Edwards Lifesciences.
WASHINGTON - A transcatheter pulmonary valve system that provides a new right ventricle to pulmonary artery conduit to congenital heart disease patients without the need for open heart surgery performed a little better in a real-world registry at 10 U.S. centers than it had in the pivotal trial that led to the system's 2010 FDA approval.
The new results "confirm the strong performance of the Melody transcatheter pulmonary valve achieved by real-world providers with results comparable to the U.S. investigational device exemption [IDE] trial," Dr. Aimee K. Armstrong said at the annual meeting of the American College of Cardiology. The "high level" of 97% freedom from transcatheter pulmonary valve (TPV) dysfunction at 1 year "was better than in the IDE trial," where the level reached 94%, noted Dr. Armstrong of the University of Michigan in Ann Arbor.
The registry study, which the FDA mandated when it approved the Melody valve in 2010, ran during July 2010 to July 2012 at 10 U.S. centers that had not participated in the pivotal trial. The 99 patients who received an implant that stayed in place for at least 1 day ranged from 5 to 45 years old, with an average age of 20 years. Although patient follow-up averaged 22 months, the study's primary endpoint was acceptable hemodynamic function within the conduit at 6 months, with a prespecified performance goal of 75% of patients achieving this outcome. The outcome actually occurred in 97% of the 90 evaluable patients at 6 months, and in 88% of all 99 patients who received a conduit. The difference between each of these rates and the performance goal was statistically significant, Dr. Armstrong said.
The transcatheter valve showed excellent performance by other criteria as well. Acceptable hemodynamic function continued through 1 year in 94% of the 87 implanted patients with evaluable data at 12 months, which translated to 83% of the entire 99 patients in the implanted group. Severe or moderate pulmonary valve regurgitation existed in 85% of the patients before treatment; after treatment no patient had severe or moderate regurgitation, and after 1 year 63% had no regurgitation, 24% had trace, and 12% had mild regurgitation (figures total 99% because of rounding). The 1-year rate of 97% of patients free from dysfunction of their implanted valve appeared to surpass the 94% rate seen in the pivotal trial (Circulation 2010;122:507-16).
The results also showed that high right ventricular pressure prior to valve placement was the only variable independently associated with subsequent valve dysfunction. "Patients who go into the procedure with a very stenotic conduit are probably at higher risk for transcatheter pulmonary valve dysfunction down the road," she said.
The study was sponsored by Medtronic, which markets the Melody transcatheter pulmonary valve. Dr. Armstrong said she has received research funding from Medtronic and Edwards Lifesciences.
Key clinical point: The Melody transcatheter pulmonary valve system worked as well in a real world registry as it did in its pivotal trial as a conduit between the right ventricle and pulmonary artery.
Major finding: Acceptable hemodynamic function at 6 months occurred in 88% of implanted patients, significantly surpassing the 75% performance goal.
Data source: A series of 99 patients who received a transcatheter pulmonary valve at any of 10 participating U.S. centers.
Disclosures: The study was sponsored by Medtronic, which markets the Melody transcatheter pulmonary valve. Dr. Armstrong said that she has received consultant fees and honoraria from Siemens Healthcare and St. Jude Medical, and has received research funding from Medtronic and Edwards Lifesciences.
