Key result
TPVI using the 65-cm-long DrySeal sheath significantly reduced median valve delivery time compared to the e-sheath (4 min 33 s vs. 9 min 6 s, p=0.002) and had zero procedural complications.
Why the study?
The study was conducted to assess the utility of the 65-cm-long Gore DrySeal sheath compared to the standard 36-cm-long Edwards expandable sheath (e-sheath) for transcatheter pulmonary valve implantation with the Edwards Sapien 3 valve.
Does the 65-cm-long Gore DrySeal sheath reduce valve delivery time and procedural complications compared to the standard 36-cm e-sheath in patients undergoing TPVI with the Sapien 3 valve?
Cohort (n=94)
No
Does the 65-cm-long Gore DrySeal sheath reduce valve delivery time and procedural complications compared to the standard 36-cm e-sheath in patients undergoing TPVI with the Sapien 3 valve?
Answers are grounded in this paper and cite their sources.
The use of a 65-cm-long DrySeal sheath during transcatheter pulmonary valve implantation with the Sapien 3 valve significantly reduces valve delivery time and procedural complications compared to the standard e-sheath.
OBJECTIVE: To assess the utility of the 65-cm-long Gore DrySeal sheath when compared to the standard 36-cm-long Edwards expandable sheath (e-sheath) for transcatheter pulmonary valve implantation (TPVI) with the Edwards Sapien 3 valve. METHODS: All patients who underwent TPVI with the Sapien 3 valve, excluding those performed via hybrid approach, at our center between September 2015 and November 2019 were retrospectively reviewed and compared between two groups. RESULTS: A total of 94 patients were enrolled; 29 patients underwent TPVI with the Sapien valve using the DrySeal sheath and 65 underwent TPVI using the e-sheath. The height and body weight of patients implanted using the DrySeal sheath ranged from 137 to 193 cm and from 33 to 129 kg, respectively. Valve delivery time was significantly shorter in the DrySeal group (median time 4 min 33 s vs. 9 min 6 s, p = .002). There were no complications in the DrySeal group (0/27). Nine procedural complications occurred in the e-sheath group (9/65), five of which were potentially directly related to sheath choice, including tricuspid valve injury in four and embolization of the tip of the e-sheath during retrieval of a ruptured balloon in one patient. CONCLUSIONS: TPVI with the Sapien 3 valve using the 65-cm-long DrySeal sheath facilitates faster and safer valve implantation when compared to the e-sheath.
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Fukuda et al. (2020) conducted a cohort in Transcatheter pulmonary valve implantation (TPVI) (n=94). 65-cm-long Gore DrySeal sheath vs. Standard 36-cm-long Edwards expandable sheath (e-sheath) was evaluated on Valve delivery time (p=.002). TPVI using the 65-cm-long DrySeal sheath significantly reduced median valve delivery time compared to the e-sheath (4 min 33 s vs. 9 min 6 s, p=0.002) and had zero procedural complications.
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