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Harmony Transcatheter Pulmonary Valve 1-Year Outcomes
Quick Takes
- A pooled analysis of patients from all 3 phases of the Harmony TPV trials reported no mortality or substantial morbidity, stable device position, with no evidence of traumatic erosion or embolization or migration from the initial implantation site.
- Overall results demonstrate favorable clinical and hemodynamic outcomes across studies and valve types through 1 year.
- Continued follow-up of this patient cohort through 10 years is indicated to allow long-term evaluation of valve performance and durability.
Study Questions:
What is the 1-year safety and effectiveness of the Harmony transcatheter pulmonary valve (TPV) for severe pulmonary regurgitation (PR) in the native or surgically repaired right ventricular outflow tract (RVOT)?
Methods:
The investigators analyzed a pooled population of patients from the Harmony Native Outflow Tract Early Feasibility Study, Harmony TPV Pivotal Study, and Continued Access Study. Eligible patients had severe PR by echocardiography or PR fraction ≥30% by cardiac magnetic resonance imaging and clinical indications for pulmonary valve replacement. The primary analysis included 87 patients who received a commercially available TPV22 (n = 42) or TPV25 (n = 45) device; 19 patients who received an early device iteration prior to its discontinuation were evaluated separately.
Results:
In the primary analysis, median patient age at treatment was 26 years (interquartile range [IQR], 18-37 years) in the TPV22 group and 29 years (IQR, 19-42 years) in the TPV25 group. At 1 year, there were no deaths; 98% of TPV22 and 91% of TPV25 patients were free from the composite of PR, stenosis, and reintervention (moderate or worse PR, mean RVOT gradient >40 mm Hg, device-related RVOT reoperation, and catheter reintervention). Nonsustained ventricular tachycardia occurred in 16% of patients. Most patients had none/trace or mild PR (98% of TPV22 patients, 97% of TPV25 patients). Outcomes with the discontinued device are reported separately.
Conclusions:
The authors report that the Harmony TPV device demonstrated favorable clinical and hemodynamic outcomes across studies and valve types through 1 year.
Perspective:
This pooled analysis of patients from all 3 phases of the Harmony TPV trials who have completed ≥1 year of follow-up report no mortality or substantial morbidity, stable device position, with no evidence of traumatic erosion or embolization or migration from the initial implantation site. Furthermore, there were no episodes of endocarditis or sustained arrhythmia and just one occurrence of thrombosis, which resolved with anticoagulation. Overall results demonstrate favorable clinical and hemodynamic outcomes across studies and valve types through 1 year. Continued follow-up of this patient cohort through 10 years is indicated to allow long-term evaluation of valve performance and durability.
Clinical Topics: Arrhythmias and Clinical EP, Cardiac Surgery, Congenital Heart Disease and Pediatric Cardiology, Invasive Cardiovascular Angiography and Intervention, Noninvasive Imaging, Valvular Heart Disease, Implantable Devices, SCD/Ventricular Arrhythmias, Atrial Fibrillation/Supraventricular Arrhythmias, Cardiac Surgery and Arrhythmias, Cardiac Surgery and CHD and Pediatrics, Cardiac Surgery and VHD, Congenital Heart Disease, CHD and Pediatrics and Arrhythmias, CHD and Pediatrics and Imaging, CHD and Pediatrics and Interventions, Interventions and Imaging, Interventions and Structural Heart Disease, Echocardiography/Ultrasound, Magnetic Resonance Imaging
Keywords: Arrhythmias, Cardiac, Cardiac Surgical Procedures, Coronary Stenosis, Diagnostic Imaging, Echocardiography, Heart Defects, Congenital, Heart Valve Diseases, Hemodynamics, Magnetic Resonance Imaging, Pulmonary Valve, Pulmonary Valve Insufficiency, Reoperation, Tachycardia, Ventricular, Thrombosis, Young Adult
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