The international multicenter registry aims to collect real-world data on clinical outcomes and evaluate the net clinical success of transcatheter microvascular plug (MVP)-based pulmonary flow restrictors (PFRs) in patients with congenital and acquired heart disease.
This is a multicenter, international, non-randomized, non-interventional, observational post-marketing clinical follow-up study with retrospective and prospective data collection, designed to evaluate the feasibility, safety, and efficacy of off-label implantation of microvascular plug (MVP)-based pulmonary flow restrictors (PFRs) in patients with congenital and acquired heart disease.
Study Type
OBSERVATIONAL
Enrollment
150
Transcatheter implantation of a microvascular plug (MVP)-based pulmonary flow restrictor (PFR) in a single or bilateral pulmonary artery (PA) branch(es).
Marie Lannelongue Hospital
Le Plessis-Robinson, France
University Medical Center Hamburg-Eppendorf
Hamburg, Germany
Mother and Child Health Institute of Serbia
Belgrade, Serbia
Al Jalila Children's Specialty Hospital
Dubai, United Arab Emirates
Net clinical success
Composite non-hierarchical net clinical success, evaluated at the time of surgical PFR removal (either as a standalone procedure or during target surgery), and defined by meeting the following three criteria: 1) technical success (successful implantation and retention\* of the MVP device in each branch PA), 2) clinical success (evidence of PBF restriction\*\* at PFR removal), and 3) safety success (no major adverse device-related events (MADREs).
Time frame: From date of device implant until the date of surgical device removal, assessed up to 24 months
Technical implantation success
Technical success of PFR implantation (device successfully delivered, deployed, and retained in each branch PA) at hospital discharge after the index procedure.
Time frame: From date of device implant until hospital discharge, assessed up to 6 weeks
Immediate flow restriction success
Immediate flow restriction success of MVP-based PFRs, defined as technical success and evidence of pulmonary blood flow (BPF) restriction, at procedure conclusion (Evidence of PBF restriction at procedure conclusion was defined as a minimal drop in oxygen saturation on arterial blood gas by 10% at the same level of FiO2 compared to preoperative levels, a systolic-diastolic Doppler-pattern across the PFRs with a minimum peak Doppler gradient of 40 mmHg (Vmax=3.2 m/s) on per-procedural ultrasound assessment, and, when performed, a reduction in the baseline QP/QS mismatch by 50%).
Time frame: From device implant to procedure conclusion
Safety success
Safety success (freedom from MADREs\*, vascular-, or procedure-related SAEs\*\*) at the time of device removal. The severity of MADRE and SAE will be classified using a validated 1-to-5 scale, ranging from none to catastrophic. \*MADREs include device-related vascular erosion, vascular aneurysm/pseudoaneurysm, bronchial compression, device collapse, migration, embolization, thrombosis, fracture, infection, endocarditis, resulting in unplanned or anticipated device removal, or redo-intervention (surgical or catheter-based) \*\*SAEs encompassed device- vascular- or procedure-related adverse events resulting in death, life-threatening situations, hospitalization, disability, or major surgical intervention.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Leeds Teaching Hospitals NHS Trust
Leeds, United Kingdom
Time frame: From date of device implant until the date of surgical device removal, assessed up to 24 months
All cause mortality
All-cause mortality rate at the time of device removal.
Time frame: From date of device implant until the date of surgical device removal, assessed up to 24 months