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

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

Fukuda T, Tan W, Sadeghi S, Lin J, Salem M, Levi D, Aboulhosn J.

Catheter Cardiovasc Interv. 2020 Feb 19. doi: 10.1002/ccd.28776. [Epub ahead of print]

PMID: 32073725

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Take Home Points:

  • The traditional delivery approach for implantation of the Edwards Sapien 3 valve in the pulmonary position comes with risks of tricuspid valve injury and need for additional steps for advancement of the valve into proper position.
  • The modified technique of using a Gore DrySeal long sheath for valve delivery, instead of the recommended Edwards expandable sheath (e-sheath), can decrease delivery time, increase procedural safety, and improve ease of retrieval of ruptured balloons.

Dr. Arash Salavitabar (Ann Arbor MI)
Commentary from Dr. Arash Salavitabar (Ann Arbor MI), catheterization section editor of Pediatric Cardiology Journal Watch: Percutaneous transcatheter pulmonary valve implantation (TPVI) with the Edwards Sapien 3 (S3) valve is a well-described procedure that clearly fills a void in TPVI choices for patients with congenital heart disease. Tricuspid valve (TV) injury is a known complication TPVI with the Edwards S3 valve when using the recommended Edwards expandable sheath (e-sheath). This risk is thought to be increased due to the need to advance an uncovered, balloon-mounted stented valve across the tricuspid valve and into the right ventricular outflow tract (RVOT) with this system. The authors report on single-center outcomes of an off-label modified delivery technique, which involves the use of a Gore DrySeal long sheath, in place of the standard e-sheath, for delivery of the S3 valve.
Of the 94 patients who underwent percutaneous implantation of the S3 valve in the pulmonic position during an approximately 4-year period, the DrySeal sheath was utilized in 29 patients (30.8%). The most common (38.3%) landing zone was a patched, or “native”, RVOT. Pre-stents were utilized in 1/3 of patients, most often in the setting of a RV-to-PA conduit.
The authors found that valve delivery time (time from insertion of S3 valve into sheath to valve deployment) was shorter in the DrySeal group when compared to the e-sheath group (median 4 min 33 sec vs. 9 min 6 sec, p=0.002). The delivery time was reported to be longest with the first 2 patients of center’s experience with utilizing the DrySeal sheath for this indication, and this was thought to be secondary to not obtaining sheath position distal enough into the MPA or proximal branch pulmonary artery prior to valve insertion. Those cases were complicated by the sheath dropping into the RV cavity, resulting in ventricular arrhythmias and valve delivery similar to the steps taken when using the e-sheath. Delivery times were improved once the technical adjustment was made to obtain more distal sheath position. Median fluoroscopy time was shorter for the DrySeal group as well (median 33 min 24 sec vs. 44 min 1 sec, p=0.04).
There was a significantly higher rate of complications in the e-sheath group (13.9% vs. 0%, p=0.04). Notably, the 2 types of complications that are thought to be protected against by utilizing the DrySeal sheath comprised 5 of 9 acute procedural complications in the e-sheath group: tricuspid valve injury (4) and femoral venous dissection (1). Importantly 3 of the 4 TV injuries ultimately required surgical intervention. Additionally, 2 cases were reported in which retrieval of a ruptured delivery balloon was difficult with the e-sheath and resulted in embolization of the tip of the e-sheath in one and TV injury in the other.
Although this is an initial single-center experience with this modified delivery technique for TPVI with the Edwards Sapien 3 valve, the authors present promising results of decreased procedural time and safety with this approach.