Long Term Outcomes Following Transcatheter Pulmonary Valve Implantation With SAPIEN 3 Valve : a Multicentre International Study

1. INTRODUCTION Percutaneous pulmonary valve implantation (PPVI) is effective to treat right ventricle outflow (RVOT) dysfunction. First reported by Bonhoeffer et al. in 2000, PPVI extends the lifespan of an existing RVOT revision and delays the need for repeat surgical intervention. First limited to patients with dysfunctional right-ventricle to pulmonary artery conduit, its feasibility was extended to patients with bioprosthesis, small expandable conduits and native RVOT. In select patients, it is nowadays a first-line approach to PV replacement. With longer follow-up, some issues arose such as the incidence of infective endocarditis (IE). It remains highly debatable if the risk of IE varied according to the type of implanted valve. Tricuspid valve injuries were also reported while advancing a valve without covering along the right heart cavities. However, most of the current evidence has been gathered using the early generation Melody (Medtronic Inc., Minneapolis, MN) or Edwards SAPIEN valves (Edwards Lifesciences, Irvine, CA).

Ongoing prosthesis improvement programmes have led to the availability of the SAPIEN 3 (S3), a bovine pericardial valve mounted on a fatigue-resistant cobalt chromium alloy stent with inclusion of an outer polyethylene terephthalate skirt, available in 20, 23, 26 and 29 mm in diameter. First implanted in 2014 in pulmonary position and subsequently described in preliminary multicentre reports, PPVI with the S3 valve appears to be safe and feasible in a wide range of patients with congenital heart defects, including those with large native RVOT. Use of this valve and its smooth deflectable Commander delivery system has been shown to facilitate PPVI, together with the use of a long introducer delivery sheath. The procedures resulted in good short-term haemodynamic and functional outcomes, with very few adverse events, paving the way for worldwide implantation of the S3 valve in the pulmonic position. Furthermore, while prestenting is systematically recommended before implanting a Melody valve to decrease the risk of stent fracture during follow-up, S3 design and radial strength resulted in a modification of implantation method with decreased prestenting indications. However, positive safety and efficacy outcomes remains to be demonstrated over the longer term. There is currently little formal data on S3 implantation in the pulmonic position over few months. The objective of the present multicentre registry analysis was to explore safety, feasibility, and haemodynamic outcomes of PPVI using the S3 to up to five years. 2. METHODS We designed a retrospective multicentre cohort study including all consecutives PPVI of a S3 valve between 2014 and decembre 2021 in European, Canadian and middle-east centres.

The study was approved by an ethical committees (GERM IRB 00012157, reference 543, 27 October 2021) and performed in accordance with the Declaration of Helsinki and its amendments.

2.1 Centres These centres are situated in Europe (France, United-Kingdom, Germany, Italy, Spain, Switzerland, Poland), the Middle East (Turkey, Israel), and Canada. No minimum requirements pertaining to number of implants or operator experience are specified.

2.2 Patients Inclusion criteria were a clinical indication for PPVI and a prior implantation of the S3 in the pulmonic position, with the decision to perform the procedure taken independently. So as to represent the broadest possible spectrum of patients undergoing PPVI, no further inclusion/exclusion criteria were stipulated. PPVI is usually indicated in symptomatic patients or those with evidence of RV or left ventricular systolic dysfunction, severe RV enlargement with an indexed RV end-diastolic volume of greater than 160 mL/m2, or an indexed RV end-systolic volume of greater than 80 mL/m2 and those with decreases in exercise capacity.