Tricuspid regurgitation as a complication of Edwards Sapien XT valve implantation in pulmonary position a problem to deal with

Objectives To describe a multi‐center experience of percutaneous transcatheter pulmonary valve replacement (TPVR) using the Edwards Sapien S3 Valve. Background Off‐label use of the Sapien S3 valve can allow for TPVR in patients with congenital heart disease (CHD) and large diameter dysfunctional right ventricular outflow tract (RVOT). The initial experience at five centers with the SAPIEN S3 valve for TPVR is presented with a focus on procedural techniques, success, complications, and efficacy. Methods A retrospective review was performed of all patients with CHD and dysfunctional RVOT who underwent TPVR using Sapien S3 valve. Imaging data, procedural elements, and clinical follow‐up data were collected to evaluate acute and short‐term results. Results A total of 50 patients underwent percutaneous placement of the Sapien S3 in the pulmonary position. Of these, 38 were placed into “native RVOTs”, measuring 24–32 mm in diameter, as assessed by compliant balloon sizing. In all cases, the valve was implanted after introduction and there were no cases of valve embolization. On follow up (range 1–9 months, median 3 months), no patients had significant obstruction or regurgitation through or around the valve requiring intervention. There were no procedural deaths. Major complications included severe aortic compression (n = 1) and tricuspid valve (TV) injury related to valve placement (n = 2) and prestenting (n = 1). Conclusions TPVR in patients with large diameter dysfunctional RVOTs can be effectively performed with the Sapien S3. All procedures were technically successful with no embolizations, no perivalvular leaks, and excellent short‐term valve function. Tricuspid valve injury from implantation of an uncovered valve was a serious procedural complication.

Section: Discussionmentioning

confidence: 79%

Initial results from the off‐label use of the SAPIEN S3 valve for percutaneous transcatheter pulmonary valve replacement: A multi‐institutional experience

Sinha

Aboulhosn

Asnes

et al. 2018

“…One of the major concerns in relation to delivery of the SAPIEN XT and SAPIEN 3 valves to the native RVOT has been the potential for tricuspid valve damage, which has been reported on a number of occasions . Unlike other valves used for tPVR, the SAPIEN valves are uncovered leading to potential entanglement while passing the tricuspid valve.…”

Section: Discussionmentioning

confidence: 99%

“…This may lead to interplay between the tricuspid valve apparatus, the pusher catheter, and the uncovered mounted valve as they are maneuvered move back and forth. A number of reports have described damage to the tricuspid valve in this setting with rates of 6–7.5%. It is unclear if this is influenced by persisting with attempts to deliver the valve to the RVOT, due to possible difficulties in removing the Edwards SAPIEN valve through the standard eSheath.…”

Section: Introductionmentioning

confidence: 99%

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

Kenny

Morgan

Murphy

et al. 2019

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.

“…The delivery systems for the Sapien family of valves are stiff and do not conform to the angulations of the right heart. As such, reports of tricuspid valve injury during placement have been published . This has led to the development of innovative techniques for Sapien valve implantation in the pulmonary position; however, these techniques remain suboptimal.…”

Section: Introductionmentioning

confidence: 99%

“…As such, reports of tricuspid valve injury during placement have been published. 10 This has led to the development of innovative techniques for Sapien valve implantation in the pulmonary position; [11][12][13] however, these techniques remain suboptimal. A recent report also describes using a long sheath to cover the valve.…”

Section: Introductionmentioning

confidence: 99%

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

Shahanavaz

Rockefeller

Nicolas

et al. 2018

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.