Stefanescu Schmidt AC, Armstrong AK, Aboulhosn JA, Kennedy KF, Jones TK, Levi DS, McElhinney DB, Bhatt AB. JACC Cardiovasc Interv. 2024 Jan 22;17(2):231-244. doi: 10.1016/j.jcin.2023.10.065. PMID: 38267137
Take Home Points
- Melody valves were used more often over the entire study period (57%) though there was an evolution in valve type with Sapien valves contributing to more than 50% of implants by 2020.
- Melody valves were used more often in younger patients, patients with conduits and patients with RVOT stenosis whereas Sapien valves were more commonly used in patients with predominant PR and those with native/patched RVOTs
- Center experience with the TPVR procedure varied widely with most centers reporting <10 cases per year
Commentary from Dr. Jonathon Hagel (C.S. Mott Children’s Hospital, University of Michigan)
After its initial commercial approval in the United States in 2010, transcatheter pulmonary valve replacement (TPVR) has expanded and evolved. The authors sought to examine real world patient and procedural characteristics of TPVR using data from the IMPACT (Improving Pediatric and Adult Congenital Treatment) registry which includes 106 participating sites. Their secondary objectives were to describe acute hemodynamic outcomes and major adverse events (MAEs) associated with the procedure.
Patients who had a TPVR procedure entered in the IMPACT registry with an implant date between April 2016 and March 2021 were included in the study. This timeframe represents the only approved commercially available devices at the time being the Melody and Sapien transcatheter pulmonary valve (TPV). Notably, this timeframe excludes newer self-expanding TPV platforms designed specifically for large native/patched RVOTs. Those in whom a device was not implanted, were treated with a self-expanding TPV or who had no data entered for valve type were excluded from analysis. Over the 5-year study period, 4936 TPVR procedures were attempted of which 4513 met the inclusion criteria. The average yearly volume was <10 cases at more than two-thirds of centers.
The median age at implant was 19 years (13, 31) with 10% of patients weighing <30 Kg and 3% of patients <20 Kg. Acute success was achieved in 95% of patients however an optimal hemodynamic outcome with peak-to-peak invasive gradient of <15 mmHg was only achieved in 83% of patients. MAEs were reported in 2.4% of cases and were significantly less common in patients with a BPV (1.4%) compared to those with a homograft (2.9%) or native/patched RVOT (3.4%) (P=0.004). In multivariable analysis, age (10-19 yrs vs. 19-40 yrs), RVOT type (BPV vs. Homograft) and femoral venous access were significantly associated with lower risk of MAEs after adjusting for valve type, year or procedure and TPVR annual center volume.
Using this large national registry of children and adults with congenital heart disease there were several key findings. First, one quarter of implants were performed into native/patched outflow tracts which is an off-label application of these devices. Second, patients weighing <30Kg (who were excluded from the initial Melody and Sapien clinical trials) represented 10% of this cohort. Emergent/urgent TPVR cases were rare but more likely to be associated with MAEs and less likely to be successful. MAEs were uncommon with one reported procedural death, a small number of cardiac arrests, ECMO and unplanned cardiac or vascular surgery.