Ignite Creation Date:
2024-05-06 @ 7:55 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06186258
Status:
COMPLETED
Last Update Posted:
2023-12-29
First Post:
2023-12-15
Brief Title:
Infective Endocarditis in Percutaneous Pulmonary Revalvulation Comparison Between Melody and Sapien Valves
Sponsor:
Centre Chirurgical Marie Lannelongue
Organization:
Centre Chirurgical Marie Lannelongue
Study Overview
Official Title:
Infective Endocarditis in Percutaneous Pulmonary Revalvulation a Direct Comparison Between Melody and Sapien Valves
Status:
COMPLETED
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Endopulm
Brief Summary:
Percutaneous pulmonary valve revalvulation PPVR has emerged as an alternative to surgery for the treatment of congenital heart disease with right ejection pathway dysfunction The Melody valve Medtronic Inc Minneapolis Minnesota was the first to be used validated in 2006 by the European Commission and in 2010 by the Food and Drug Administration FDA Subsequently the Sapien valve Edwards SAPIEN pulmonic transcatheter heart valve Edwards Lifesciences Irvine California was subsequently approved for PPVR Europe 2010 FDA 2016
Infective endocarditis IE after PPVR is currently a major concern with an incidence after Melody PPVR estimated at 3 much higher than the rate of prosthetic left-heart IE The Sapien valve has been introduced more recently and some cases of IE have been published Despite the attention this issue is receiving there are few studies of sufficient size or statistical power to elucidate the risk factors for developing an IE after PPVR according to the type of valve implanted Recently a multicenter study was published by the American team of McElhinney et al J Am Coll Cardiol 2021 78 575-589 Although it was a sizeable cohort 2476 patients there was a large disparity in the ratio of patients who underwent revalvulation with either the Melody or Sapien valve in favor of Melody patients 2038 Melody patients vs 438 Sapien patients In this study the estimated risk of IE was higher for patients who received a Melody valve according to univariable analysis but not anymore after multivariate analysis To further answer this question we develop an international retrospective multicenter registry whose main objective will be to characterize the incidence rate of infective endocarditis after percutaneous pulmonary revalvulation according to the type of valve implanted Melody vs Sapien using a large population of patients with comparable characteristics match-population
Infective endocarditis IE after PPVR is currently a major concern with an incidence after Melody PPVR estimated at 3 much higher than the rate of prosthetic left-heart IE The Sapien valve has been introduced more recently and some cases of IE have been published Despite the attention this issue is receiving there are few studies of sufficient size or statistical power to elucidate the risk factors for developing an IE after PPVR according to the type of valve implanted Recently a multicenter study was published by the American team of McElhinney et al J Am Coll Cardiol 2021 78 575-589 Although it was a sizeable cohort 2476 patients there was a large disparity in the ratio of patients who underwent revalvulation with either the Melody or Sapien valve in favor of Melody patients 2038 Melody patients vs 438 Sapien patients In this study the estimated risk of IE was higher for patients who received a Melody valve according to univariable analysis but not anymore after multivariate analysis To further answer this question we develop an international retrospective multicenter registry whose main objective will be to characterize the incidence rate of infective endocarditis after percutaneous pulmonary revalvulation according to the type of valve implanted Melody vs Sapien using a large population of patients with comparable characteristics match-population
Detailed Description:
Infective endocarditis IE is a dreaded complication in patients with congenital heart disease CHD with an incidence up to 100-fold compared to the general population In CHD such as cono-truncal defects the right ventricular outflow tract RVOT is reconstructed using patches conduits homografts or bioprosthetic valves Subsequently pulmonary regurgitation conduit degeneration or conduit mismatch due to growth may require repeated valve andor conduit replacement Transcatheter pulmonary valve implantation TPVI is an effective treatment for RVOT dysfunction as an alternative to surgical pulmonary valve replacement TPVI was first described in 2000 and since then many studies have supported its safety and efficacy The MELODY valve Medtronic Inc Minneapolis MN was used first and received European certification in 2006 and FDA approval in 2010 The SAPIEN valve series Edwards SAPIEN pulmonic transcatheter heart valve and SAPIEN 3 valve Edwards Lifesciences Irvine CA were subsequently licensed for TPVI Europe 2010 and FDA 2016 The feasibility of TPVI was initially demonstrated in right ventricle-to-pulmonary artery conduits and then in bioprostheses small expandable conduits and native or patched RVOTs IE after TPVI TPVI-IE remains a life-threatening adverse event that affects valve durability and patient outcomes National and international recommendations provide only meager guidance about the management of TPVI-IE A history of IE Di George syndrome male sex younger age at implant and increased valve gradient have been identified as risk factors for IE However it remains a matter of debate whether the type of valve influences the risk of IE Although the bovine jugular vein valves like the MELODY valve and the CONTEGRA conduit are mentioned as specific risk factors for IE in the German guidelines for IE other authors did not support this in a large multicentre study An important limitation is that most of studies had limited duration of follow-up particularly after SAPIEN-TPVI whereas endocarditis has been equally described many years following TPVI The objective of this study was to identify additional risk factors for TPVI-IE over the long-term
METHODS A retrospective study of the multicentre international ENDOCPULM registry including consecutive patients after successful MELODY and SAPIEN-TPVI between 2007 and 2021 in 35 tertiary European and Middle-East centres was designed The study was approved by an independent ethics committee GERM IRB 00012157 552 December 17th 2021 and was performed in accordance with the Declaration of Helsinki and its amendments This report complies with STROBE guidelines for cohort studies
METHODS A retrospective study of the multicentre international ENDOCPULM registry including consecutive patients after successful MELODY and SAPIEN-TPVI between 2007 and 2021 in 35 tertiary European and Middle-East centres was designed The study was approved by an independent ethics committee GERM IRB 00012157 552 December 17th 2021 and was performed in accordance with the Declaration of Helsinki and its amendments This report complies with STROBE guidelines for cohort studies
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None