Key result
Delivery of the Edwards SAPIEN valve using a 65 cm Gore Dryseal sheath in patients with dysfunctional right ventricular outflow tracts achieved a 100% success rate.
Why the study?
The Edwards SAPIEN valve and its delivery system may complicate transit through the right heart during transcatheter pulmonary valve replacement.
Does the use of a 65 cm Gore Dryseal Sheath facilitate safe and successful delivery of the Edwards SAPIEN valve in patients with dysfunctional right ventricular outflow tracts?
Observational (n=30)
Yes
Does the use of a 65 cm Gore Dryseal Sheath facilitate safe and successful delivery of the Edwards SAPIEN valve in patients with dysfunctional right ventricular outflow tracts?
The use of a 65 cm large caliber Dryseal sheath safely and effectively facilitates the delivery of the Edwards SAPIEN valve for transcatheter pulmonary valve replacement in patients with dysfunctional right ventricular outflow tracts.
Answers are grounded in this paper and cite their sources.
Suggests feasibility of 65 cm Dryseal sheath for SAPIEN delivery in dysfunctional RVOTs; hypothesis-generating and requires prospective validation.
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.
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Kenny et al. (2019) conducted an observational in Dysfunctional right ventricular outflow tracts (n=30). 65 cm Gore Dryseal Sheath was evaluated on Successful valve delivery to the target area. Delivery of the Edwards SAPIEN valve using a 65 cm Gore Dryseal sheath in patients with dysfunctional right ventricular outflow tracts achieved a 100% success rate.
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