Author + information
- Received February 25, 2018
- Revision received August 8, 2018
- Accepted September 4, 2018
- Published online November 26, 2018.
- Doff B. McElhinney, MDa,∗ (, )@StanfordChild,
- Lars Sondergaard, MD, DMScb,
- Aimee K. Armstrong, MDc,
- Lisa Bergersen, MD, MPHd,
- Robert F. Padera, MD, PhDe,
- David T. Balzer, MDf,
- Te-Hsin Lung, PhDg,
- Felix Berger, MDh,
- Evan M. Zahn, MDi,
- Robert G. Gray, MDj,
- William E. Hellenbrand, MDk,
- Jacqueline Kreutzer, MDl,
- Andreas Eicken, MDm,
- Thomas K. Jones, MDn and
- Peter Ewert, MD, PhDm
- aLucile Packard Children’s Hospital Stanford, Palo Alto, California
- bThe Heart Center, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark
- cNationwide Children’s Hospital, Columbus, Ohio
- dBoston Children's Hospital, Boston, Massachusetts
- eBrigham and Women's Hospital, Children's Hospital Boston and Harvard Medical School, Boston, Massachusetts
- fSt. Louis Children’s Hospital, St. Louis, Missouri
- gMedtronic, Santa Rosa, California
- hDeutsches Herzzentrum Berlin, Berlin, Germany
- iCedars-Sinai Heart Institute, Los Angeles, California
- jUniversity of Utah, Salt Lake City, Utah
- kYale School of Medicine, New Haven, Connecticut
- lChildren’s Hospital of Pittsburgh of UPMC, Pittsburgh, Pennsylvania
- mGerman Heart Center Munich, Munich, Germany
- nSeattle Children’s Hospital, Seattle, Washington
- ↵∗Address for correspondence:
Dr. Doff B. McElhinney, Stanford University, 780 Welch Road, Suite CJ110, Palo Alto, California 94304.
Background Endocarditis has emerged as one of the most concerning adverse outcomes in patients with congenital anomalies involving the right ventricular outflow tract (RVOT) and prosthetic valves.
Objectives The aim of this study was to evaluate rates and potential risk factors for endocarditis after transcatheter pulmonary valve replacement in the prospective Melody valve trials.
Methods All patients in whom a transcatheter pulmonary valve (TPV) was implanted in the RVOT as part of 3 prospective multicenter studies comprised the analytic cohort. The diagnosis of endocarditis and involvement of the TPV were determined by the implanting investigator.
Results A total of 309 patients underwent transcatheter pulmonary valve replacement (TPVR) and were discharged with a valve in place. The median follow-up duration was 5.1 years, and total observation until study exit was 1,660.3 patient-years. Endocarditis was diagnosed in 46 patients (median 3.1 years after TPVR), and a total of 35 patients were reported to have TPV-related endocarditis (34 at the initial diagnosis, 1 with a second episode). The annualized incidence rate of endocarditis was 3.1% per patient-year and of TPV-related endocarditis was 2.4% per patient-year. At 5 years post-TPVR, freedom from a diagnosis of endocarditis was 89% and freedom from TPV-related endocarditis was 92%. By multivariable analysis, age ≤12 years at implant (hazard ratio: 2.3; 95% confidence interval: 1.2 to 4.4; p = 0.011) and immediate post-implant peak gradient ≥15 mm Hg (2.7; 95% confidence interval: 1.4 to 4.9; p = 0.002) were associated with development of endocarditis and with development of TPV-related endocarditis (age ≤12 years: 2.8; 95% confidence interval: 1.3 to 5.7; p = 0.006; gradient ≥15 mm Hg: 2.6; 95% confidence interval: 1.3 to 5.2; p = 0.008).
Conclusions Endocarditis is an important adverse outcome following TVPR in children and adults with post-operative congenital heart disease involving the RVOT. Ongoing efforts to understand, prevent, and optimize management of this complication are paramount in making the best use of TPV therapy. (Melody Transcatheter Pulmonary Valve [TPV] Study: Post Approval Study of the Original Investigational Device Exemption [IDE] Cohort; NCT00740870; Melody Transcatheter Pulmonary Valve Post-Approval Study; NCT01186692; and Melody Transcatheter Pulmonary Valve [TPV] Post-Market Surveillance Study; NCT00688571)
This work was supported by Medtronic. Dr. McElhinney has served as a proctor and consultant for Medtronic. Dr. Sondergaard has received consultant fees and institutional research grants from Edwards Lifesciences and Medtronic. Dr. Armstrong has served as a proctor for Medtronic, Edwards Lifesciences, Abbott Vascular, and B. Braun Interventional Systems. Dr. Bergersen has served as a consultant for 480 Biomedical. Dr. Berger has received research grant support from Philips Healthcare, St. Jude Medical, Edwards Lifesciences, Medtronic, and Gore Medical; has participated on steering board activities with Actelion Pharmaceuticals, Medtronic, Daiichi-Sankyo, and Pfizer; and has received lecture honoraria from Actelion Pharmaceuticals, Bayer, Medtronic, Novartis, and St. Jude Medical. Dr. Padera has served as a consultant for Medtronic. Dr. Balzer is a proctor for Medtronic and Abbott Vascular; and has served as a Principal Investigator for Medtronic. Dr. Lung is an employee and shareholder of Medtronic. Dr. Zahn has served as a proctor and consultant for Medtronic, Edwards Lifesciences, and Abbott Vascular; is the national Principal Investigator for the Edwards Lifesciences Alterra Study; and is the national Principal Investigator for the Abbott Vascular ADO II-AS Study. Dr. Hellenbrand has served as a proctor and consultant for Medtronic; and has served as a proctor for Edwards Lifesciences. Dr. Kreutzer has received research support from Medtronic and Edwards Lifesciences; and has served as a consultant for Medtronic. Dr. Eicken has served as a proctor for Medtronic. Dr. Jones has received research support from Medtronic and Edwards Lifesciences; and has served as a consultant and scientific advisory board member for Medtronic. Prof. Ewert is a proctor for the Melody valve (Medtronic) and for the Sapien Pulmonic valve (Edwards Lifesciences). All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received February 25, 2018.
- Revision received August 8, 2018.
- Accepted September 4, 2018.
- 2018 American College of Cardiology Foundation
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