Key result
Sapien valve linked to ~80% lower risk of infective endocarditis vs. Melody in TPVI.
Why the study?
There is uncertainty regarding the overall incidence of infective endocarditis after transcatheter pulmonary valve implantation and whether infective endocarditis risk differs between Melody and Sapien valves.
Does the Sapien valve reduce the risk of infective endocarditis compared to the Melody valve in patients undergoing transcatheter pulmonary valve implantation?
Meta-Analysis (n=1,967)
Does the Sapien valve reduce the risk of infective endocarditis compared to the Melody valve in patients undergoing transcatheter pulmonary valve implantation?
Sapien valves demonstrate a significantly lower risk of post-procedural infective endocarditis compared to Melody valves, supporting their preferential use when anatomically suitable.
Answers are grounded in this paper and cite their sources.
May favor Sapien over Melody to reduce IE risk in TPVI; leaves open need for randomized confirmation.
Background: Transcatheter pulmonary valve implantation (TPVI) is an effective non-surgical treatment method for patients with right ventricle outflow tract dysfunction. The Medtronic Melody and the Edwards Sapien are the two valves approved for use in TPVI. Since TPVI patients are typically younger, even a modest annual incidence of infective endocarditis (IE) is significant. Several previous studies have shown a growing risk of IE after TPVI. There is uncertainty regarding the overall incidence of IE and differences in the risk of IE between the valves. Methods: A systematic search was conducted in the MEDLINE, EMBASE, PubMed, and Cochrane databases from inception to 1 January 2023 using the search terms ‘pulmonary valve implantation’, ‘TPVI’, or ‘PPVI’. The primary outcome was the pooled incidence of IE following TPVI in Melody and Sapien valves and the difference in incidence between Sapien and Melody valves. Fixed effect and random effect models were used depending on the valve. Meta-regression with random effects was conducted to test the difference in the incidence of IE between the two valves. Results: A total of 22 studies (including 10 Melody valve studies, 8 Sapien valve studies, and 4 studies that included both valves (572 patients that used the Sapien valve and 1395 patients that used the Melody valve)) were used for the final analysis. Zero IE incidence following TPVI was reported by eight studies (66.7%) that utilized Sapien valves compared to two studies (14.3%) that utilized Melody valves. The pooled incidence of IE following TPVI with Sapien valves was 2.1% (95% CI: 0.9% to 5.13%) compared to 8.5% (95% CI: 4.8% to 15.2%) following TPVI with Melody valves. Results of meta-regression indicated that the Sapien valve had a 79.6% (95% CI: 24.2% to 94.4%, p = 0.019; R2 = 34.4) lower risk of IE incidence compared to the Melody valve. Conclusions: The risk of IE following TPVI differs significantly. A prudent valve choice in favor of Sapien valves to lower the risk of post-TPVI endocarditis may be beneficial.
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Balakrishna et al. (2023) conducted a meta-analysis in Right ventricle outflow tract dysfunction requiring transcatheter pulmonary valve implantation (n=1,967). Sapien transcatheter pulmonary valve vs. Melody transcatheter pulmonary valve was evaluated on Pooled incidence of infective endocarditis (79.6% lower risk, 95% CI 24.2% to 94.4%, p=0.019). The Sapien valve was associated with a 79.6% lower risk of infective endocarditis compared to the Melody valve following transcatheter pulmonary valve implantation.
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