Comparison of the investigational device exemption and post-approval trials of the Melody transcatheter pulmonary valve

Jacqueline Kreutzer; Aimee K. Armstrong; Jonathan J. Rome; Thomas M. Zellers; David T. Balzer; Jeffrey D. Zampi; Allison K. Cabalka; Alexander J. Javois; Daniel R. Turner; Robert G. Gray; John W. Moore; Shicheng Weng; Thomas K. Jones; Danyal M. Khan; Julie A. Vincent; William E. Hellenbrand; John P. Cheatham; Lisa J. Bergersen; Doff B. McElhinney

doi:10.1002/ccd.29657

Comparison of the investigational device exemption and post-approval trials of the Melody transcatheter pulmonary valve

Jacqueline Kreutzer, Aimee K. Armstrong, Jonathan J. Rome, Thomas M. Zellers, David T. Balzer, Jeffrey D. Zampi, Allison K. Cabalka, Alexander J. Javois, Daniel R. Turner, Robert G. Gray, John W. Moore, Shicheng Weng, Thomas K. Jones, Danyal M. Khan, Julie A. Vincent, William E. Hellenbrand, John P. Cheatham, Lisa J. Bergersen, Doff B. McElhinney

Research output: Contribution to journal › Article › peer-review

5 Scopus citations

Abstract

Objective: We compared 5-year outcomes of transcatheter pulmonary valve (TPV) replacement with the Melody TPV in the post-approval study (PAS) and the investigational device exemption (IDE) trial. Background: As a condition of approval of the Melody TPV after the IDE trial, the Food and Drug Administration required that a PAS be conducted to evaluate outcomes of TPV replacement in a “real-world” environment. The 5-year outcomes of the PAS have not been published, and the IDE and PAS trials have not been compared. Methods: The cohorts comprised all patients catheterized and implanted at 5 IDE sites and 10 PAS sites. Differences in trial protocols were detailed. Time-related outcomes and valve-related adverse events were compared between the two trials with Kaplan–Meier curves and log-rank testing. Results: 167 patients (median age, 19 years) were catheterized and 150 underwent TPV replacement in the IDE trial; 121 were catheterized (median age, 17 years) and 100 implanted in the PAS. Freedom from hemodynamic dysfunction (p =.61) or any reintervention (p =.74) over time did not differ between trials. Freedom from stent fracture (p =.003) and transcatheter reintervention (p =.010) were longer in PAS, whereas freedom from explant (p =.020) and TPV endocarditis (p =.007) were shorter. Clinically important adverse events (AEs) were reported in 14% of PAS and 7.2% of IDE patients (p =.056); the incidence of any particular event was low in both. Conclusions: Hemodynamic and time-related outcomes in the PAS and IDE trials were generally similar, confirming the effectiveness of the Melody TPV with real-world providers. There were few significant complications and limited power to identify important differences in AEs. The lack of major differences in outcomes between the two studies questions the usefulness of mandated costly post-approval studies as part of the regulatory process for Class III medical devices.

Original language	English (US)
Pages (from-to)	E262-E274
Journal	Catheterization and Cardiovascular Interventions
Volume	98
Issue number	2
DOIs	https://doi.org/10.1002/ccd.29657
State	Published - Aug 1 2021

Keywords

pulmonary heart disease
tetralogy of Fallot
transcatheter pulmonary valve replacement

ASJC Scopus subject areas

Radiology Nuclear Medicine and imaging
Cardiology and Cardiovascular Medicine

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10.1002/ccd.29657

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Kreutzer, J., Armstrong, A. K., Rome, J. J., Zellers, T. M., Balzer, D. T., Zampi, J. D., Cabalka, A. K., Javois, A. J., Turner, D. R., Gray, R. G., Moore, J. W., Weng, S., Jones, T. K., Khan, D. M., Vincent, J. A., Hellenbrand, W. E., Cheatham, J. P., Bergersen, L. J., & McElhinney, D. B. (2021). Comparison of the investigational device exemption and post-approval trials of the Melody transcatheter pulmonary valve. Catheterization and Cardiovascular Interventions, 98(2), E262-E274. https://doi.org/10.1002/ccd.29657

Kreutzer, J, Armstrong, AK, Rome, JJ, Zellers, TM, Balzer, DT, Zampi, JD, Cabalka, AK, Javois, AJ, Turner, DR, Gray, RG, Moore, JW, Weng, S, Jones, TK, Khan, DM, Vincent, JA, Hellenbrand, WE, Cheatham, JP, Bergersen, LJ & McElhinney, DB 2021, 'Comparison of the investigational device exemption and post-approval trials of the Melody transcatheter pulmonary valve', Catheterization and Cardiovascular Interventions, vol. 98, no. 2, pp. E262-E274. https://doi.org/10.1002/ccd.29657

@article{4f93a2c1eaa54688889ef002253f6e42,

title = "Comparison of the investigational device exemption and post-approval trials of the Melody transcatheter pulmonary valve",

abstract = "Objective: We compared 5-year outcomes of transcatheter pulmonary valve (TPV) replacement with the Melody TPV in the post-approval study (PAS) and the investigational device exemption (IDE) trial. Background: As a condition of approval of the Melody TPV after the IDE trial, the Food and Drug Administration required that a PAS be conducted to evaluate outcomes of TPV replacement in a “real-world” environment. The 5-year outcomes of the PAS have not been published, and the IDE and PAS trials have not been compared. Methods: The cohorts comprised all patients catheterized and implanted at 5 IDE sites and 10 PAS sites. Differences in trial protocols were detailed. Time-related outcomes and valve-related adverse events were compared between the two trials with Kaplan–Meier curves and log-rank testing. Results: 167 patients (median age, 19 years) were catheterized and 150 underwent TPV replacement in the IDE trial; 121 were catheterized (median age, 17 years) and 100 implanted in the PAS. Freedom from hemodynamic dysfunction (p =.61) or any reintervention (p =.74) over time did not differ between trials. Freedom from stent fracture (p =.003) and transcatheter reintervention (p =.010) were longer in PAS, whereas freedom from explant (p =.020) and TPV endocarditis (p =.007) were shorter. Clinically important adverse events (AEs) were reported in 14% of PAS and 7.2% of IDE patients (p =.056); the incidence of any particular event was low in both. Conclusions: Hemodynamic and time-related outcomes in the PAS and IDE trials were generally similar, confirming the effectiveness of the Melody TPV with real-world providers. There were few significant complications and limited power to identify important differences in AEs. The lack of major differences in outcomes between the two studies questions the usefulness of mandated costly post-approval studies as part of the regulatory process for Class III medical devices.",

keywords = "pulmonary heart disease, tetralogy of Fallot, transcatheter pulmonary valve replacement",

author = "Jacqueline Kreutzer and Armstrong, {Aimee K.} and Rome, {Jonathan J.} and Zellers, {Thomas M.} and Balzer, {David T.} and Zampi, {Jeffrey D.} and Cabalka, {Allison K.} and Javois, {Alexander J.} and Turner, {Daniel R.} and Gray, {Robert G.} and Moore, {John W.} and Shicheng Weng and Jones, {Thomas K.} and Khan, {Danyal M.} and Vincent, {Julie A.} and Hellenbrand, {William E.} and Cheatham, {John P.} and Bergersen, {Lisa J.} and McElhinney, {Doff B.}",

note = "Funding Information: Megan Mueller supported study management. Julie A. Linick provided copyediting and figure development support under the direction of the authors. Both are employees of Medtronic. Publisher Copyright: {\textcopyright} 2021 Wiley Periodicals LLC.",

year = "2021",

month = aug,

day = "1",

doi = "10.1002/ccd.29657",

language = "English (US)",

volume = "98",

pages = "E262--E274",

journal = "Catheterization and Cardiovascular Interventions",

issn = "1522-1946",

publisher = "Wiley-Liss Inc.",

number = "2",

}

TY - JOUR

T1 - Comparison of the investigational device exemption and post-approval trials of the Melody transcatheter pulmonary valve

AU - Kreutzer, Jacqueline

AU - Armstrong, Aimee K.

AU - Rome, Jonathan J.

AU - Zellers, Thomas M.

AU - Balzer, David T.

AU - Zampi, Jeffrey D.

AU - Cabalka, Allison K.

AU - Javois, Alexander J.

AU - Turner, Daniel R.

AU - Gray, Robert G.

AU - Moore, John W.

AU - Weng, Shicheng

AU - Jones, Thomas K.

AU - Khan, Danyal M.

AU - Vincent, Julie A.

AU - Hellenbrand, William E.

AU - Cheatham, John P.

AU - Bergersen, Lisa J.

AU - McElhinney, Doff B.

N1 - Funding Information: Megan Mueller supported study management. Julie A. Linick provided copyediting and figure development support under the direction of the authors. Both are employees of Medtronic. Publisher Copyright: © 2021 Wiley Periodicals LLC.

PY - 2021/8/1

Y1 - 2021/8/1

N2 - Objective: We compared 5-year outcomes of transcatheter pulmonary valve (TPV) replacement with the Melody TPV in the post-approval study (PAS) and the investigational device exemption (IDE) trial. Background: As a condition of approval of the Melody TPV after the IDE trial, the Food and Drug Administration required that a PAS be conducted to evaluate outcomes of TPV replacement in a “real-world” environment. The 5-year outcomes of the PAS have not been published, and the IDE and PAS trials have not been compared. Methods: The cohorts comprised all patients catheterized and implanted at 5 IDE sites and 10 PAS sites. Differences in trial protocols were detailed. Time-related outcomes and valve-related adverse events were compared between the two trials with Kaplan–Meier curves and log-rank testing. Results: 167 patients (median age, 19 years) were catheterized and 150 underwent TPV replacement in the IDE trial; 121 were catheterized (median age, 17 years) and 100 implanted in the PAS. Freedom from hemodynamic dysfunction (p =.61) or any reintervention (p =.74) over time did not differ between trials. Freedom from stent fracture (p =.003) and transcatheter reintervention (p =.010) were longer in PAS, whereas freedom from explant (p =.020) and TPV endocarditis (p =.007) were shorter. Clinically important adverse events (AEs) were reported in 14% of PAS and 7.2% of IDE patients (p =.056); the incidence of any particular event was low in both. Conclusions: Hemodynamic and time-related outcomes in the PAS and IDE trials were generally similar, confirming the effectiveness of the Melody TPV with real-world providers. There were few significant complications and limited power to identify important differences in AEs. The lack of major differences in outcomes between the two studies questions the usefulness of mandated costly post-approval studies as part of the regulatory process for Class III medical devices.

AB - Objective: We compared 5-year outcomes of transcatheter pulmonary valve (TPV) replacement with the Melody TPV in the post-approval study (PAS) and the investigational device exemption (IDE) trial. Background: As a condition of approval of the Melody TPV after the IDE trial, the Food and Drug Administration required that a PAS be conducted to evaluate outcomes of TPV replacement in a “real-world” environment. The 5-year outcomes of the PAS have not been published, and the IDE and PAS trials have not been compared. Methods: The cohorts comprised all patients catheterized and implanted at 5 IDE sites and 10 PAS sites. Differences in trial protocols were detailed. Time-related outcomes and valve-related adverse events were compared between the two trials with Kaplan–Meier curves and log-rank testing. Results: 167 patients (median age, 19 years) were catheterized and 150 underwent TPV replacement in the IDE trial; 121 were catheterized (median age, 17 years) and 100 implanted in the PAS. Freedom from hemodynamic dysfunction (p =.61) or any reintervention (p =.74) over time did not differ between trials. Freedom from stent fracture (p =.003) and transcatheter reintervention (p =.010) were longer in PAS, whereas freedom from explant (p =.020) and TPV endocarditis (p =.007) were shorter. Clinically important adverse events (AEs) were reported in 14% of PAS and 7.2% of IDE patients (p =.056); the incidence of any particular event was low in both. Conclusions: Hemodynamic and time-related outcomes in the PAS and IDE trials were generally similar, confirming the effectiveness of the Melody TPV with real-world providers. There were few significant complications and limited power to identify important differences in AEs. The lack of major differences in outcomes between the two studies questions the usefulness of mandated costly post-approval studies as part of the regulatory process for Class III medical devices.

KW - pulmonary heart disease

KW - tetralogy of Fallot

KW - transcatheter pulmonary valve replacement

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DO - 10.1002/ccd.29657

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JO - Catheterization and Cardiovascular Interventions

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ER -

Comparison of the investigational device exemption and post-approval trials of the Melody transcatheter pulmonary valve

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