Infective Endocarditis After Transcatheter Pulmonary Valve Replacement Using the Melody Valve

Abstract

Background-Transcatheter (percutaneous) pulmonary valve (TPV) replacement has emerged as a viable therapy for right ventricular outflow tract conduit dysfunction. Little is known about the incidence, clinical course, and outcome of infective endocarditis (IE) after TPV implant. We reviewed combined data from 3 ongoing prospective multicenter trials to evaluate the experience with IE among patients undergoing TPV replacement using the Melody valve. Methods and Results-Any clinical episode reported by investigators as IE with documented positive blood cultures and fever, regardless of TPV involvement, was considered IE. Cases were classified as TPV-related if there was evidence of vegetations on or new dysfunction of the TPV. The 3 trials included 311 patients followed for 687.1 patient-years (median, 2.5 years). Sixteen patients were diagnosed with IE 50 days to 4.7 years after TPV implant (median, 1.3 years), including 6 who met criteria for TPV-related IE: 3 with vegetations, 2 with TPV dysfunction, and 1 with both. The annualized rate of a first episode of IE was 2.4% per patient-year and of TPV-related IE was 0.88% per patient-year. Freedom from TPV-related IE was 97±1% 4 years after implant. All patients were treated with intravenous antibiotics, 4 had the valve explanted, and 2 received a second TPV. There was 1 sepsis-related death, 1 patient died of sudden hemoptysis, and 2 patients developed recurrent IE. Key Words: endocarditis ◼ pulmonary regurgitation ◼ pulmonary stenosis ◼ pulmonary valve ◼ Ross procedure ◼ tetralogy of Fallot Conclusions-Bacterial

Infective Endocarditis After Melody Valve Implantation in the Pulmonary Position: A Systematic Review

“…In studies applying the modified Duke criteria (n=4 studies16, 19, 21, 22), the cumulative incidence of IE ranged from 7.5% to 25.0%, and the annualized incidence rate ranged from 3.7% to 6.3%. Both cumulative and annualized incidences of IE were higher in studies with lower numbers of patients (Figure 1A and 1B14, 15, 16, 17, 18, 19, 20, 21, 22). On the other hand, the incidence was not influenced by the follow‐up duration (Figure 2A and 2B14, 15, 16, 17, 18, 19, 20, 21, 22).…”

“…Both cumulative and annualized incidences of IE were higher in studies with lower numbers of patients (Figure 1A and 1B14, 15, 16, 17, 18, 19, 20, 21, 22). On the other hand, the incidence was not influenced by the follow‐up duration (Figure 2A and 2B14, 15, 16, 17, 18, 19, 20, 21, 22). Figure 3 shows a summary of the time period of patient enrollment in each study and the respective cumulative (Figure 3A14, 15, 16, 17, 18, 19, 20, 21, 22) and annualized incidence rate of IE (Figure 3B14, 15, 16, 17, 18, 19, 20, 21, 22), both trending to be higher in later than in earlier studies.…”

“…A total of 9 studies14, 15, 16, 17, 18, 19, 20, 21, 22 were included in the analysis of the incidence of IE after TPVI using the Melody valve. The characteristics of the studies are summarized in Table 1.…”

“…Scatter plots of the cumulative (A) and annualized (B) incidence rate of infective endocarditis ( IE ) plotted against the sample size (number of patients) of the individual studies14, 15, 16, 17, 18, 19, 20, 21, 22 (Spearman correlation coefficient=−0.80 and −0.73, P =0.010 and P =0.025, respectively).…”

“…In addition to patient‐related risk factors (eg, older age,26 male sex,26 history of IE,17 discontinuation of antiplatelets,29 and exposure to unprotected medical procedure29) and procedure‐related risk factors (eg, longer procedure,26 higher number of stents,26 and higher residual RVOT gradient14), some inherent device characteristics have been indicated by histopathologic studies as risk factors predisposing to IE. A selective propensity of bovine jugular tissue (the precursor of the Melody valve leaflets) to histological lesions during procedural steps45 and to bacterial adherence46 was shown in in‐vitro studies, especially after procedural manipulation‐induced leaflet damage 46.…”