A recent study has revealed excellent real-world outcomes associated with the use of the self-expanding Harmony valve in transcatheter pulmonary valve replacement (TPVR) procedures. The findings, published recently, highlight the valve's effectiveness in addressing pulmonary regurgitation (PR) and maintaining hemodynamic stability in patients. The study emphasizes the importance of recognizing potential risks associated with TPVR to improve clinical outcomes.
The study reported acute technical success in nearly all patients, with 96% experiencing no or trivial PR. A significant majority, 86%, were discharged within one day post-procedure, while the mean length of stay for the remaining 14% was just two days, primarily due to chest pain, ventricular arrhythmia, or procedural adverse events.
Long-Term Outcomes
After a median follow-up period of 13 months, 98% of patients exhibited mild or less PR, and the median right ventricular outflow tract (RVOT) gradient was 10 mm Hg. Freedom from the composite clinical outcome—hemodynamic dysfunction and/or RVOT reintervention—was observed in 99% of patients after one year and 96% after two years. However, five patient deaths occurred during the follow-up period.
Adverse Events
TPV-related thrombosis was diagnosed in 3.4% of patients, at a median of four months post-procedure. Endocarditis was either diagnosed or suspected in 2.6% of patients after a median of 11 months. According to the study authors, one thrombosis case occurred in the setting of COVID-19 infection, while the other cases were not associated with known medical diagnoses.
Expert Commentary
The researchers noted that the small number of adverse events serves as a crucial reminder of the risks associated with TPVR. They emphasized that provider recognition of these risks should promote earlier diagnosis and treatment, potentially improving clinical outcomes and reducing the need for anatomic RVOT reintervention. The researchers concluded that real-world outcomes for these patients were excellent and plan to continue follow-up to gather more data over time.
