Endocarditis After Transcatheter Pulmonary Valve Replacement

JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY

卷:72

Article

McElhinney, Doff B.¹  Sondergaard, Lars²  Armstrong, Aimee K.³  Bergersen, Lisa⁴  Padera, Robert F.^5,6  Balzer, David T.⁷  Lung, Te-Hsin⁸  Berger, Felix⁹  Zahn, Evan M.¹⁰  Gray, Robert G.¹¹  Hellenbrand, William E.¹²  Kreutzer, Jacqueline¹³  Eicken, Andreas¹⁴  Jones, Thomas K.¹⁵  Ewert, Peter¹⁴ 

[1] Lucile Packard Childrens Hosp Stanford, Palo Alto, CA USA

[2] Univ Copenhagen, Ctr Heart, Rigshosp, Copenhagen, Denmark

[3] Nationwide Childrens Hosp, Columbus, OH USA

[4] Boston Childrens Hosp, Boston, MA USA

[5] Childrens Hosp Boston, Brigham & Womens Hosp, Boston, MA USA

[6] Harvard Med Sch, Boston, MA USA

[7] St Louis Childrens Hosp, St Louis, MO 63178 USA

[8] Medtronic, Santa Rosa, CA USA

[9] Deutsch Herzzentrum Berlin, Berlin, Germany

[10] Cedars Sinai Heart Inst, Los Angeles, CA USA

[11] Univ Utah, Salt Lake City, UT USA

[12] Yale Sch Med, New Haven, CT USA

[13] UPMC, Childrens Hosp Pittsburgh, Pittsburgh, PA USA

[14] German Heart Ctr Munich, Munich, Germany

[15] Seattle Childrens Hosp, Seattle, WA USA

关键词: infection;    percutaneous valve;    pulmonary valve;    tetralogy of Fallot;   

DOI  :  10.1016/j.jacc.2018.09.039

来源: Elsevier

【 摘 要 】

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 postoperative 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) (c) 2018 by the American College of Cardiology Foundation.

【 授权许可】

Free