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Melody Transcatheter Pulmonary Valve Replacement in Native RVOT
Study Questions:
What is the safety and feasibility of transcatheter pulmonary valve replacement (TPVR) using the Melody valve in native (nonconduit) right ventricular outflow tracts (nRVOTs)?
Methods:
The investigators conducted a multicenter retrospective study of all patients (n = 229) presenting for nRVOT TPVR, collected pre-procedural magnetic resonance imaging (MRI), echocardiography, and catheterization data, and evaluated procedural and early outcomes. Successful implantation was defined as Melody valve implantation in the pulmonary position without surgical manipulation of the RVOT. Receiver operating characteristic curve analysis was performed to determine optimal cutoff values of MRI RVOT measurements/parameters: calculated elliptical area, maximum anterior-posterior diameter and maximum left-right diameter, and C-statistics were calculated. Graphical representation was also performed to explore relationships between RVOT measurements and successful Melody valve implant.
Results:
Of 229 patients (age 21 ± 15 years from 11 centers), 132 (58%) had successful TPVR. In the remaining 97, TPVR was not performed, most often because of prohibitively large nRVOT (n = 67) or compression of the aortic root or coronary arteries (n = 18). There were no deaths and five (4%) serious complications, including pre-stent embolization requiring surgery in four patients, and arrhythmia in one. Higher pre-catheterization echocardiographic RVOT gradient was associated with TPVR success (p = 0.001), and larger center volume approached significance (p = 0.08). MRI anterior-posterior and lateral RVOT diameters were smaller in implanted versus nonimplanted patients (18.0 ± 3.6 mm vs. 20.1 ± 3.5 mm; p = 0.005; 18.4 ± 4.3 mm vs. 21.5 ± 3.8 mm; p = 0.002).
Conclusions:
The authors concluded that TPVR in the nRVOT was feasible and safe.
Perspective:
This study reports that overall, Melody TPVR was feasible, safe, and beneficial in patients with nRVOT dysfunction. However, significant challenges existed in the identification of appropriate patients for the procedure, with 42% of patients presenting for possible TPVR found to be poor candidates at the time of catheterization. Establishing MRI or other standardized noninvasive imaging criteria that predict successful implant may improve patient selection. Due to the marked variability in the shape, size, and dynamic nature of the nRVOT, and the availability of newer TPVR devices, additional studies are needed to optimize TPVR therapy for the individual patient with nRVOT dysfunction. Furthermore, long-term follow-up is needed to assess durability and valve function over time.
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, Cardiac Catheterization, Diagnostic Imaging, Echocardiography, Heart Defects, Congenital, Heart Valve Diseases, Magnetic Resonance Imaging, Pulmonary Valve Insufficiency, Stents, Transcatheter Aortic Valve Replacement, Ventricular Outflow Obstruction
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