The Impact of Improved Percutaneous Pulmonary Valve Design on Patient Characteristics: Smaller, Younger, and More Complex

Objectives: The SAPIEN 3 (S3; Edwards Lifescience, Irvine, CA, USA) is a new design of a transcatheter heart valve (THV) with lower delivery profile and available sizes from 23 to 29 mm. The aim of this study was to compare the patient characteristics receiving earlier Edwards THV types, like the Sapien and Sapien XT valves to the current patient population eligible for percutaneous pulmonary valve implantation (PPVI).

Methods: During 2011 and 2017, 74 patients were treated with PPVI in two centers. Patient data and valve types were evaluated retrospectively.

Results: From 2011 to 2013 the Sapien valve was implanted in 24 cases, followed by the Sapien XT from 2013 to 2016 (n = 24). Since 2015 PPVI was increasingly performed with the S3 valve (n = 26). In the S3 group, patients showed a tendency to be younger (p > 0.05) and were significantly smaller (p < 0.05) when compared with earlier THV types:

Sapien 3 (n = 26): Median age, 13.5 (range: 5.8–52 years); median weight, 51.5 kg (range: 15.0–93.0 kg) (n = 4 < 20 kg).

Sapien XT (n = 24): Median age, 17.7 (range: 7.8–44.2 years); median weight, 64 kg (range: 21.5–106 kg).

Sapien (n = 24): Median age 17.9 (range 6.6–42 years); median weight 60 kg (range 20.0–135 kg); valve sizes used were mostly 23 and 26 mm (Sapien n = 23; XT n = 16; S3 n = 20). The largest 29 mm model is increasingly used during the last years (XT n = 3, S3 n = 6).

Compared with the initial Sapien group, the S3 group showed a broader variety of underlying congenital heart diseases (CHD) and increased procedural complexity (Sapien-in-Melody implantation, PPVI in a single PA, PPVI in the native RVOT).

Conclusion: Alterations to the design of transcatheter pulmonary valves and their delivery systems during the past 6 years led to considerable change of patient characteristics suitable for PPVI.

Compared with the Edwards Sapien and XT valves, patients who received the latest Edwards Sapien 3 valve tended to be smaller (even below 20 kg) and younger. Right now PPVI is applicable in a broader variety and more complex cohort of CHD. A THV size of 29 mm is increasingly utilized.