Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05264181 |
| Other study ID # |
2022-564 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
September 1, 2021 |
| Est. completion date |
August 1, 2022 |
Study information
| Verified date |
February 2022 |
| Source |
Centre Chirurgical Marie Lannelongue |
| Contact |
Sebastien Hascoet, MD, PhD |
| Phone |
0140942429 |
| Email |
s.hascoet[@]ghpsj.fr |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Background Transcatheter pulmonary valve implantation (TPVI) is indicated to treat right
ventricular outflow tract dysfunction in patients with congenital heart diseases. Long-term
outcomes following this procedure using the new generation SAPIEN 3 valve is little known.
Purpose This study aims to report mid-term outcomes in a large cohort of patients who had
TPVI using the SAPIEN 3 valve.
Methods We designed a retrospective multicentre observational registry of patients undergoing
TPVI with the SAPIEN 3 valve across centres in Europe, Middle-east and Canada.
Patient-related, procedural, and mid-term outcomes data will be characterized.
Description:
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.
PPVI was performed using SAPIEN 3 valve in all cases. The SAPIEN 3 valve is
characterized by a trileaflet valve crafted from bovine pericardium treated with the
same ThermaFix process as Carpentier-Edwards surgical valves. The valve is sutured to a
cobalt-chromium stent frame with optimized cell design to minimize profile and improve
radial strength. Additionally, the SAPIEN 3 has an outer polyethylene terephthalate
skirt which decreases the incidence of paravalvular leak. The SAPIEN 3 valve is
available in 20- 23-, 26-, and 29-mm sizes and is introduced using the Commander
delivery system (14 and 16-Fr expandable sheaths). It has obtained CE mark in 2021.
2.3 Data collection Given the wide range of patients represented in the study, the
Pulmonic S3 electronic case report form (eCRF) was designed to accommodate the broadest
possible spectrum of clinical settings in which PPVI may be indicated. As such, the data
collected reflects the site's standard procedures, including but not limited to physical
assessments, ECGs, laboratory testing, and cardiac imaging. Data entry was performed by
the treating physician or study nurse through retrospective appraisal of medical
records.
Data regarding patient demographics, underlying diagnoses and RVOT anatomies were
collected for the period prior to PPVI, with peri-procedural details and outcomes also
documented. Follow-up time points for the assessment of adverse events and functional
outcomes were 30 days, six months, one and two years. Data were subjected to regular
automatic and manual checks for plausibility and completeness.
2.4 Outcomes and definitions Key haemodynamic and functional outcomes included changes
in the peak systolic gradient over RVOT; degree of pulmonary regurgitation following
PPVI. Feasibility was assessed according to procedural success (defined as successful
implantation of a single valve at the intended location and retrieval of the delivery
catheter), while safety outcomes included the rates of periprocedural technical
complications (device malfunction [defined as failure to meet performance specifications
or otherwise perform as expected]; valve dislocation requiring surgical intervention;
and stent dislocation), periprocedural adverse events (significant bleeding; arrhythmia
requiring pacing, drugs or cardioversion; conduit/RVOT rupture requiring emergency
stenting or surgery; significant neurological impairment [based on clinical assessment;
coronary compression; myocardial infarction; pulmonary embolism; and periprocedural
death).
2.5 Statistics Data are presented as descriptive data summaries. Categorical variables
are expressed as absolute numbers and frequencies (%), while continuous variables are
expressed as means with standard deviations (SD) and minimum-maximum data ranges.
3. RESULTS 3.1 Patient characteristics will be displayed 3.2 Procedural characteristics
will be displayed 3.3 Periprocedural outcomes and safety will be reported
- What is known:
Percutaneous pulmonary valve implantation is safe and effective to treat right ventricle
outflow tract dysfunction in patients with congenital heart diseases A wide spectrum of
devices are being used currently. The new-generation SAPIEN 3 valve has recently been
labelled for percutaneous pulmonary valve implantation.
• What the Study will Add: SAPIEN 3 Three and Five-years freedom from secondary pulmonary
valve replacement will be reported SAPIEN 3 Annualized Incidence of infective endocarditis
will be reported.
