Infective Endocarditis in Percutaneous Pulmonary Revalvulation: Comparison Between Melody and Sapien Valves

NCT06186258 | Completed DMC FDA Device

• 1 other identifier: 2022-552
• Study Type: observational
• Target: 300
• Locations: 7 countries
• Sites: 18

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).

Conditions

Infective Endocarditis; Congenital Heart Disease; Percutaneous Pulmonary Valve Implantation

Keywords

percutaneous pulmonary valve implantation; Sapien 3; Melody; Transcatheter pulmonary valve replacement; infective endocarditis; congenital heart disease

Outcome Measures

Primary Outcomes (1)

• compare the risk of long-term infective endocarditis after percutaneous pulmonary revalvulation with Melody, Sapien XT, Sapien S3 valves.

  risk of long-term infective endocarditis after percutaneous pulmonary as defined by annualized incidence of infective endocarditis

  10 years

Secondary Outcomes (1)

• Major cardiovascular events

  10 years

Study Arms (2)

Patients who underwent successful percutaneous pulmonary revalvulation with the Melody valve

Data from patients managed for a pulmonary revalvulation procedure with the Melody valve between 01/01/2007 and 31/12/2021 will be collected. Cases of infective endocarditis will be meticulously examined and classified as certain, possible or refuted, according to the modified Duke algorithm proposed by the European Society of Cardiology. Cases of endocarditis occurring within one year of pulmonary revalvulation will be classified as early IE and other cases as late IE

Device: percutaneous pulmonary valve implantation (PPVI)

Patients who underwent successful percutaneous pulmonary revalvulation with the Sapien 3, XT valve

Data from patients managed for a pulmonary revalvulation procedure with the Sapien 3, XT valve between 01/01/2007 and 31/12/2021 will be collected. Cases of infective endocarditis will be meticulously examined and classified as certain, possible or refuted, according to the modified Duke algorithm proposed by the European Society of Cardiology. Cases of endocarditis occurring within one year of pulmonary revalvulation will be classified as early IE and other cases as late IE

Device: percutaneous pulmonary valve implantation (PPVI)

Interventions

percutaneous pulmonary valve implantation (PPVI) DEVICE

The only inclusion criterion is a successful PPVI to treat RVOT dysfunction. Procedural techniques were at each operator's discretion as well as post-procedure treatments and patient's follow-up. As we sought to assess IE incidence during follow-up, patients who underwent catheterization for intended PPVI but who did not had a successful valve implantation were not included. Successful PPVI was defined as patient discharged alive without valve surgery after successful valve implantation in the RVOT.

Patients who underwent successful percutaneous pulmonary revalvulation with the Melody valve; Patients who underwent successful percutaneous pulmonary revalvulation with the Sapien 3, XT valve

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The cohort will be made up of patients who have undergone successful percutaneous pulmonary revalvulation with the Melody valve, matched with patients who have undergone revalvulation with the Sapien valve (Sapien 3 and XT) between the years 2007 and 2021.

You may qualify if:

• Minor or adult patients who have undergone a successful percutaneous pulmonary revalvulation procedure
• Patients or legal guardians who do not object to the use of their data for this research.

You may not qualify if:

• Patients under guardianship or curatorship
• Patient deprived of liberty
• Patient under court protection
• Patient or legal guardian objecting to the use of his or her data for this research

Sponsors & Collaborators

• Centre Chirurgical Marie Lannelongue: lead

Study Sites (18)

CHU Bordeaux

Bordeaux, 33000, France

Location

CHU de Grenoble

Grenoble, 38500, France

Location

Hopital Marie Lannelongue

Le Plessis-Robinson, 92350, France

Location

CHRU Lille

Lille, 59000, France

Location

CHU de la Timone

Marseille, France

Location

CHU de Nantes

Nantes, 44000, France

Location

Clinique Pasteur

Toulouse, 31000, France

Location

CHU Toulouse

Toulouse, 31300, France

Location

Medical Hospital of the university of Munich

Munich, Germany

Location

Bambin Gesù Hospital,

Rome, Italy

Location

Hospital de Santa Marta, Centro Hospitalar Lisboa Central-EPE

Lisbon, Portugal

Location

King Faisal Hospital

Jeddah, Saudi Arabia

Location

Vall d'Hebron University Hospital

Barcelona, Spain

Location

12 de Octubre University Hospital,

Madrid, Spain

Location

H. Ramón y Cajal University Hospital

Madrid, Spain

Location

Cardiology university Hospitals Birmingham

Birmingham, United Kingdom

Location

Bristol Heart Institute, University Hospitals Bristol & Weston NHS Foundation Trust

Bristol, United Kingdom

Location

Royal Brompton Hospital

London, United Kingdom

Location

Related Publications (6)

• Godart F, Baruteau AE, Petit J, Riou JY, Sassolas F, Lusson JR, Fraisse A, Boudjemline Y. Transcatheter tricuspid valve implantation: a multicentre French study. Arch Cardiovasc Dis. 2014 Nov;107(11):583-91. doi: 10.1016/j.acvd.2014.07.051. Epub 2014 Oct 2.

  PMID: 25282331 BACKGROUND

• Hascoet S, Acar P, Boudjemline Y. Transcatheter pulmonary valvulation: current indications and available devices. Arch Cardiovasc Dis. 2014 Nov;107(11):625-34. doi: 10.1016/j.acvd.2014.07.048. Epub 2014 Oct 31.

  PMID: 25444020 BACKGROUND

• Malekzadeh-Milani S, Houeijeh A, Jalal Z, Hascoet S, Bakloul M, Aldebert P, Piechaud JF, Heitz F, Bouvaist H, Dauphin C, Guerin P, Villemain O, Petit J, Godart F, Thambo JB, Boudjemline Y; French working group of Cardiac Catheterization in Congenital Heart Disease Patients. French national survey on infective endocarditis and the Melody valve in percutaneous pulmonary valve implantation. Arch Cardiovasc Dis. 2018 Aug-Sep;111(8-9):497-506. doi: 10.1016/j.acvd.2017.10.007. Epub 2018 Mar 9.

  PMID: 29530718 BACKGROUND

• Hascoet S, Karsenty C, Tortigue M, Watkins AC, Riou JY, Boet A, Tahhan N, Fabre D, Haulon S, Brenot P, Petit J. A modified procedure for percutaneous pulmonary valve implantation of the Edwards SAPIEN 3 valve. EuroIntervention. 2019 Jan 20;14(13):1386-1388. doi: 10.4244/EIJ-D-18-00530. No abstract available.

  PMID: 30327285 BACKGROUND

• Shahanavaz S, Zahn EM, Levi DS, Aboulhousn JA, Hascoet S, Qureshi AM, Porras D, Morgan GJ, Bauser Heaton H, Martin MH, Keeshan B, Asnes JD, Kenny D, Ringewald JM, Zablah JE, Ivy M, Morray BH, Torres AJ, Berman DP, Gillespie MJ, Chaszczewski K, Zampi JD, Walsh KP, Julien P, Goldstein BH, Sathanandam SK, Karsenty C, Balzer DT, McElhinney DB. Transcatheter Pulmonary Valve Replacement With the Sapien Prosthesis. J Am Coll Cardiol. 2020 Dec 15;76(24):2847-2858. doi: 10.1016/j.jacc.2020.10.041.

  PMID: 33303074 BACKGROUND

• Le Ruz R, Plessis J, Houeijeh A, Baruteau AE, Le Gloan L, Warin Fresse K, Karsenty C, Petit J, Godart F, Hascoet S, Guerin P. Edwards SAPIEN XT transcatheter pulmonary valve implantation: 5-year follow-up in a French Registry. Catheter Cardiovasc Interv. 2021 Nov 1;98(5):990-999. doi: 10.1002/ccd.29862. Epub 2021 Jul 6.

  PMID: 34227735 BACKGROUND

MeSH Terms

Conditions

Endocarditis; Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Cardiovascular Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Alain Fraisse, MD, PhD

  Royal Brompton & Harefield NHS Foundation Trust

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2023
• First Posted: December 29, 2023
• Study Start: December 17, 2021
• Primary Completion: July 31, 2023
• Study Completion: July 31, 2023
• Last Updated: December 29, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (3); GB (3); DE (1); IT (1); SA (1); FR (8); PT (1)