A Modified Technique for Transcatheter Pulmonary Valve Implantation of SAPIEN 3 Valves in Large Right Ventricular Outflow Tract: A Matched Comparison Study

Overview

Journal J Clin Med

Specialty General Medicine

Date 2023 Dec 23

PMID 38137725

Authors

Ali Houeijeh

Clement Karsenty

Nicolas Combes

Clement Batteux

Florence Lecerf

Frederic Remy

Estibaliz Valdeolmillos

Jerome Petit

Sebastien Hascoet

Affiliations

Soon will be listed here.

Abstract

Introduction: Percutaneous pulmonary valve implantation (PPVI) with a SAPIEN 3 valve is effective for treating treat right ventricle outflow (RVOT) dysfunction. A modified technique was developed without prestenting using a protective valve delivery method. We aimed to compare the procedural results of the modified technique group (MTG) to those of patients in a conventional technique group (CTG).

Methods: We designed a matched before-after study. All consecutive PPVI with SAPIEN 3 performed in the MTG over 9 months were matched, based on the RVOT type and size, to consecutive procedures performed previously with SAPIEN 3.

Results: A total of 54 patients were included, equally distributed in the two groups. The sizes of the SAPIEN 3 valves were 23 mm (n = 9), 26 mm (n = 9), 29 mm (n = 36). The two groups were similar regarding demographic data, RVOT type, and pre-procedure hemodynamics. PPVI was performed in a single procedure in all patients of the MTG, whereas six (22.2%) patients of the CTG group underwent prestenting as a first step and valve implantation later ( = 0.02). The procedures were successful in all cases. Stent embolization was reported in two patients (7.4%) in the CTG, which were impacted in pulmonary arteries. In one case (3.7%), in the MTG, an unstable 29 mm SAPIEN 3 valve was stabilized with two stents and additional valve-in-valve implantation. The hemodynamics results were good in all cases, without significant differences between the two groups. The procedures' durations and fluoroscopy times were significantly reduced in the MTG (48.1 versus 82.6 min, < 0.0001; 15.2 versus 29.8 min, = 0.0002). During follow-up, neither stent fracture nor valve dysfunction was noticed in either group.

Conclusion: PPVI without prestenting and with a protective delivery method of the SAPIEN 3 valve significantly reduces the procedure's complexity, the duration, and the irradiation while maintaining excellent hemodynamics results in selected cases.

Citing Articles

Standardized Bench Test Evaluation of Biomechanical Characteristics of Stents Used in Right Ventricular Outflow Tract Revalvulation.

Piriou P, Plessis J, Manigold T, Letocart V, Le Ruz R, Padovani P Cardiovasc Eng Technol. 2024; 15(4):443-450.

PMID: 38468115 DOI: 10.1007/s13239-024-00726-1.

References

Husain J, Praichasilchai P, Gilbert Y, Qureshi S, Morgan G . Early European experience with the Venus P-valve®: filling the gap in percutaneous pulmonary valve implantation. EuroIntervention. 2016; 12(5):e643-51. DOI: 10.4244/EIJV12I5A105. View

Hascoet S, Dalla Pozza R, Bentham J, Carere R, Kanaan M, Ewert P . Early outcomes of percutaneous pulmonary valve implantation using the Edwards SAPIEN 3 transcatheter heart valve system. EuroIntervention. 2018; 14(13):1378-1385. DOI: 10.4244/EIJ-D-18-01035. View

Morgan G, Sadeghi S, Salem M, Wilson N, Kay J, Rothman A . SAPIEN valve for percutaneous transcatheter pulmonary valve replacement without "pre-stenting": A multi-institutional experience. Catheter Cardiovasc Interv. 2018; 93(2):324-329. DOI: 10.1002/ccd.27932. View

Faccini A, Butera G . Tricuspid regurgitation as a complication of Edwards Sapien XT valve implantation in pulmonary position a problem to deal with. Catheter Cardiovasc Interv. 2018; 91(5):927-931. DOI: 10.1002/ccd.27527. View

Ghobrial J, Levi D, Aboulhosn J . Native Right Ventricular Outflow Tract Transcatheter Pulmonary Valve Replacement Without Pre-Stenting. JACC Cardiovasc Interv. 2018; 11(6):e41-e44. DOI: 10.1016/j.jcin.2017.11.014. View

McElhinney D, Cheatham J, Jones T, Lock J, Vincent J, Zahn E . Stent fracture, valve dysfunction, and right ventricular outflow tract reintervention after transcatheter pulmonary valve implantation: patient-related and procedural risk factors in the US Melody Valve Trial. Circ Cardiovasc Interv. 2011; 4(6):602-14. DOI: 10.1161/CIRCINTERVENTIONS.111.965616. View

Boone R, Webb J, Horlick E, Benson L, Cao Q, Nadeem N . Transcatheter pulmonary valve implantation using the Edwards SAPIEN transcatheter heart valve. Catheter Cardiovasc Interv. 2009; 75(2):286-94. DOI: 10.1002/ccd.22250. View

Morgan G, Prachasilchai P, Promphan W, Rosenthal E, Sivakumar K, Kappanayil M . Medium-term results of percutaneous pulmonary valve implantation using the Venus P-valve: international experience. EuroIntervention. 2018; 14(13):1363-1370. DOI: 10.4244/EIJ-D-18-00299. View

Tengler A, Ulrich S, Fischer M, Pastor-Villaescusa B, Kanaan M, Dalla Pozza R . Rationale and feasibility of transcatheter pulmonary valve implantation in small conduits with the Edwards Sapien valves. Int J Cardiol. 2020; 325:45-50. DOI: 10.1016/j.ijcard.2020.10.017. View

10.

Plessis J, Hascoet S, Baruteau A, Godart F, Le Gloan L, Warin Fresse K . Edwards SAPIEN Transcatheter Pulmonary Valve Implantation: Results From a French Registry. JACC Cardiovasc Interv. 2018; 11(19):1909-1916. DOI: 10.1016/j.jcin.2018.05.050. View

11.

Promphan W, Prachasilchai P, Siripornpitak S, Qureshi S, Layangool T . Percutaneous pulmonary valve implantation with the Venus P-valve: clinical experience and early results. Cardiol Young. 2015; 26(4):698-710. DOI: 10.1017/S1047951115001067. View

12.

Stout K, Daniels C, Aboulhosn J, Bozkurt B, Broberg C, Colman J . 2018 AHA/ACC Guideline for the Management of Adults With Congenital Heart Disease: Executive Summary: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. J Am Coll Cardiol. 2018; 73(12):1494-1563. DOI: 10.1016/j.jacc.2018.08.1028. View

13.

Caimi A, Sturla F, Pluchinotta F, Giugno L, Secchi F, Votta E . Prediction of stenting related adverse events through patient-specific finite element modelling. J Biomech. 2018; 79:135-146. DOI: 10.1016/j.jbiomech.2018.08.006. View

14.

Rockefeller T, Shahanavaz S, Zajarias A, Balzer D . Transcatheter implantation of SAPIEN 3 valve in native right ventricular outflow tract for severe pulmonary regurgitation following tetralogy of fallot repair. Catheter Cardiovasc Interv. 2016; 88(1):E28-33. DOI: 10.1002/ccd.26480. View

15.

Shahanavaz S, Zahn E, Levi D, Aboulhousn J, Hascoet S, Qureshi A . Transcatheter Pulmonary Valve Replacement With the Sapien Prosthesis. J Am Coll Cardiol. 2020; 76(24):2847-2858. DOI: 10.1016/j.jacc.2020.10.041. View

16.

Le Ruz R, Plessis J, Houeijeh A, Baruteau A, Le Gloan L, Warin Fresse K . Edwards SAPIEN XT transcatheter pulmonary valve implantation: 5-year follow-up in a French Registry. Catheter Cardiovasc Interv. 2021; 98(5):990-999. DOI: 10.1002/ccd.29862. View

17.

Cabalka A, Hellenbrand W, Eicken A, Kreutzer J, Gray R, Bergersen L . Relationships Among Conduit Type, Pre-Stenting, and Outcomes in Patients Undergoing Transcatheter Pulmonary Valve Replacement in the Prospective North American and European Melody Valve Trials. JACC Cardiovasc Interv. 2017; 10(17):1746-1759. DOI: 10.1016/j.jcin.2017.05.022. View

18.

Cardoso R, Ansari M, Garcia D, Sandhu S, Brinster D, Piazza N . Prestenting for prevention of melody valve stent fractures: A systematic review and meta-analysis. Catheter Cardiovasc Interv. 2015; 87(3):534-9. DOI: 10.1002/ccd.26235. View

19.

Lee S, Kim G, Kim S, Jang S, Choi J, Kang I . Mid-term outcomes of the Pulsta transcatheter pulmonary valve for the native right ventricular outflow tract. Catheter Cardiovasc Interv. 2021; 98(5):E724-E732. DOI: 10.1002/ccd.29865. View

20.

Sinha S, Aboulhosn J, Asnes J, Bocks M, Zahn E, Goldstein B . Initial results from the off-label use of the SAPIEN S3 valve for percutaneous transcatheter pulmonary valve replacement: A multi-institutional experience. Catheter Cardiovasc Interv. 2018; 93(3):455-463. DOI: 10.1002/ccd.27973. View