Transcatheter SAPIEN Pulmonary Valve Replacement

Study Questions:

What are the outcomes associated with transcatheter pulmonary valve replacement (TPVR) in France using the SAPIEN valve?

Methods:

In a registry in France, 71 patients who underwent TPVR with a SAPIEN valve (Edwards Lifesciences, Irvine, CA) from April 2011 to May 2017 were included in a registry analysis of TPVR.

Results:

The median age at the time of TPVR was 26.8 years (range, 12.8-70.1 years). The primary underlying diagnoses were conotruncal malformations (common arterial trunk, tetralogy of Fallot, and variants; n = 45), prior Ross procedure (n = 18), and other diagnoses (n = 8). The indication for TPVR was pure stenosis in 33.8% of patients, pure regurgitation in 28.1%, and mixed lesions in 38.1%. TPVR was successfully implemented in 68 patients (95.8%). Prestenting of the right ventricular outflow tract was performed in 70 patients (98.6%). Early major complications occurred in four subjects (5.6%), including one death, one coronary compression, and two pulmonary valve embolizations. Three of the four major complications occurred in the first 15 operated patients. No significant regurgitation was recorded after the procedure. The transpulmonary gradient was significantly reduced from 34.5 mm Hg to 10.5 mm Hg (p < 0.0001). No patient died during a 1-month follow-up period. At 1-year follow-up, the death rate was 2.9%, and three patients (4.4%) had undergone a surgical reintervention.

Conclusions:

The authors concluded that early results with the Edwards SAPIEN valve in the pulmonary position demonstrate a high rate of procedural success.

Perspective:

TPVR has relied on the use of the Melody valve, a segment of bovine jugular vein with a central valve that is sewn inside and expandable stent; however, the Melody valve is limited to a single diameter of 18 mm, then can be dilated up to 22 mm. The Edwards SAPIEN transcatheter heart valve was initially introduced as a transcatheter alternative to surgical aortic valve replacement among inoperable elderly patients with severe calcific aortic stenosis. This heart valve system (available in 20, 23, 26, and 29 mm diameters) obtained a CE certification in Europe for TPVR at the end of 2010. These registry data suggest reasonable short-term outcomes associated with its use in the pulmonary valve position; additional experience will reveal whether the SAPIEN valve can provide durable results in patients with a broader range of right ventricular outflow tract sizes.

Clinical Topics: Cardiac Surgery, Congenital Heart Disease and Pediatric Cardiology, Invasive Cardiovascular Angiography and Intervention, Valvular Heart Disease, Aortic Surgery, Cardiac Surgery and CHD and Pediatrics, Cardiac Surgery and VHD, Congenital Heart Disease, CHD and Pediatrics and Interventions, CHD and Pediatrics and Quality Improvement, Interventions and Structural Heart Disease

Keywords: Aortic Valve Stenosis, Cardiac Surgical Procedures, Constriction, Pathologic, Embolism, Heart Defects, Congenital, Heart Valve Diseases, Heart Valve Prosthesis, Outcome Assessment (Health Care), Pulmonary Valve Insufficiency, Pulmonary Valve Stenosis, Stents, Tetralogy of Fallot, Transcatheter Aortic Valve Replacement, Truncus Arteriosus


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