Use of 65 cm large caliber Dryseal sheaths to facilitate delivery of the Edwards SAPIEN valve to dysfunctional right ventricular outflow tracts

Abstract

Background The Edwards SAPIEN valve and its delivery system may complicate transit through the right heart during transcatheter pulmonary valve replacement (tPVR). We report our early experience using a large diameter, 65 cm delivery sheath to facilitate delivery of the SAPIEN valve to the right ventricular outflow tract (RVOT). Methods Retrospective analysis of all patients from three large congenital heart centers undergoing tPVR with the Edwards SAPIEN valve delivered with the 65 cm Gore Dryseal Sheath. Results Over a 12 month period, 30 patients (17 female) with median age 17.5 years (range 8–72) underwent attempted tPVR with the SAPIEN valve delivered using the 65 cm Dryseal sheath (20–26Fr). All procedures resulted in successful valve delivery to the target area. Twenty patients had a native RVOT. The most commonly used valve diameter was 29 mm (n = 15) with the majority of cases requiring a 26Fr Dryseal sheath (n = 20). One patient with severe RVOT stenosis underwent prestenting. Median procedure time was 100 min (59–225). No patient had increase in tricuspid valve regurgitation as a consequence of valve delivery. One patient required a synchronous cardioversion for intraprocedural VT and another required ECMO postprocedure due to severe pre‐existing left ventricular dysfunction. On median follow‐up of 5 months, all patients had mild or less pulmonary regurgitation. Median peak Doppler velocity across the pulmonary valve was 2.2 m/s (1.7–4). There were no clinically relevant complications relating to vascular access. Conclusions Using 65 cm Dryseal sheaths facilitates delivery of SAPIEN valves in patients with dysfunctional RVOTs.

Utility of the long DrySeal sheath in facilitating transcatheter pulmonary valve implantation with the Edwards Sapien 3 valve

“…Recently, the modified delivery technique using the 65-cm DrySeal sheath instead of the short e-sheath has been reported. 13,14 The tip of the DrySeal sheath can quite easily be advanced into the distal main pulmonary artery and allows for rapid advancement and coverage of the Sapien valve to the pulmonary position. These studies demonstrated that this technique can facilitate valve delivery and potentially prevent tricuspid valve injury.…”

“…Previous reports have noted use of the DrySeal sheath in a patient who weighed 23.8 kg. 13 We acknowledge several limitations related to the design of this study. As this study was conducted at an experienced single center, the results may not be generalizable for all practices.…”

“…After balloon sizing and stent placement (in select patients), a DrySeal sheath was selected based on the size of the S3 valve (Table 1). 13 The 65-cm-long DrySeal sheath was advanced into the main pulmonary artery over a Lunderquist wire (Cook Medical, Bjaeverskov, Denmark) before introduction of the S3 valve. After the dilator reached the distal main pulmonary artery or proximal branch pulmonary artery, the tip of the DrySeal sheath was then advanced into the distal main pulmonary artery or proximal branch pulmonary artery while keeping the dilator stable.…”

“…11 Recently, an off-label procedural modification has been suggested to minimize tricuspid valve damage with Sapien TPVI: the use of the 65-cm-long caliber DrySeal sheath (W.L Gore & Associates, Inc., Flagstaff, AZ) ( Figure 1b), instead of the shorter 36-cm e-sheath for TPVI with the Sapien valve for delivery. 13,14 The length of the Dryseal sheath allows the Sapien valve to remain "covered" while crossing the tricuspid valve and the RVOT, as the sheath can reach the pulmonary artery when inserted from the femoral vein or the jugular vein. We describe an initial single center experience of the 65-cm-long DrySeal sheath in comparison to the e-sheath for TPVI with the thirdgeneration Edwards S3 valve.…”

Antegrade transseptal transcatheter aortic valve replacement: Back to the future?

“…Positioning the sheath in the mid left ventricle across the mitral orifice provided hemodynamic stability, relatively easy passage of the valve antegrade and protected the mitral valve apparatus from impingement, injury, or entanglement by the wire and valve delivery system. This technique is analogous to utilization of the DrySeal sheath for tricuspid valve protection during implantation of the SAPIEN valve in the pulmonary position 5 . The patient remained hemodynamically stable with the sheath across the mitral valve orifice allowing the procedure to be performed in an unhurried manner.…”