Modified delivery of SAPIEN 3 valve in the pulmonary position: Evolution of technique or dire need?

Abstract

Transcatheter pulmonary valve replacement (TPVR) is now common practice in patients with significant pulmonary regurgitation (PR), stenosis (PS), or mixed pulmonary valve disease. While the Melody valve (Medtronic, Inc.) and its delivery system were specifically designed for use in the right ventricular outflow tract (RVOT), Sapien valves (XT and S3, Edwards Lifesciences, Inc.) and their delivery systems (Novaflex and Commander) were not. As a result, placement of Sapien valves in the RVOT can be challenging secondary to the stiffness of the current delivery system. Manipulating a stiff delivery system within the RV also introduces risk to the tricuspid valve and its chordal attachments. We report a novel delivery technique for the Sapien S3 valve which has greatly simplified valve delivery into the RVOT and may potentially reduce the risk of tricuspid valve injury.

The snared wire technique for Sapien valve implantation in the pulmonary position

“…7,11 Indeed, the tricuspid valve injury is a wellknown complication of TPVR with the Sapien Valve, with a reported incidence up to 6-7.5%. 4,5,7,[11][12][13]16 For all these reasons, new and safer strategies to facilitate the delivery of this system in the pulmonary position have been described. Here, we have described the SWT which appears to be feasible, effective and relatively safe.…”

“…Various techniques have been described to assist the delivery of the Sapien valve in the pulmonary position and to reduce the incidence of tricuspid valve injury. 5,[7][8][9][10][11] Currently, the use of an appropriately sized 65 cm long DrySeal sheath seems to be the most widely accepted and adopted technique. 7,10,11 The DrySeal offers the unquestionable advantage of protecting the tricuspid valve and its apparatus from the uncovered Sapien valve and delivery system.…”

“…Excessive traction on the guidewire can lead to the loss of wire position, potentially jeopardizing the procedure. Extensive manipulations of the Sapien delivery system while negotiating the complex trajectory from the right atrium, through the tricuspid valve and the right ventricular outflow tract can result in tricuspid valve injury 5,7,12,13 . In an effort to facilitate the advancement of the Sapien valve to the pulmonary position, we implemented a technique, previously reported by Martin and colleagues to facilitate the delivery of a Melody valve in one patient, 14 named the snared wire technique (SWT).…”

“…system was designed for aortic valve replacement and has proven to be challenging for TPVR, as detailed in several reports which describe different techniques to overcome these difficulties. [5][6][7][8][9][10][11] Stiff guide wires that provide sufficient support, careful wire shaping and positioning, and most importantly, avoiding the loss of wire position are the mainstays of a successful delivery of any percutaneous valve in the pulmonary position. Excessive traction on the guidewire can lead to the loss of wire position, potentially jeopardizing the procedure.…”

SAPIEN S3 valve deployment in the pulmonary position using the gore DrySeal sheath to protect the tricuspid valve

“…57 patients who did not undergo RVOT stent implantation (most of which received S3 valves), Morgan et al4 reported that two patients (3.5%) developed significant tricuspid valve insufficiency.As tricuspid valve injury has become a growing concern, operators have sought ways to modify the delivery technique to minimize this risk during implantation of the SAPIEN S3. Shahanavaz et al5 described mounting the SAPIEN S3 on a BIB Balloon (Numed Inc.) which is then advanced through a 26 Fr 33 cm GDS sheath. In this adult-sized patient, the 33 cm sheath reached only up to the inferior vena cava, and once beyond the sheath the balloon was partially inflated to expand the distal tip to create a "carrot" (a cone-like dilation of the tip of the balloon to minimize the size mismatch between the balloon tip and the bare valve).…”