期刊
JACC-CARDIOVASCULAR INTERVENTIONS
卷 16, 期 15, 页码 1917-1928出版社
ELSEVIER SCIENCE INC
DOI: 10.1016/j.jcin.2023.03.002
关键词
congenital heart disease; pulmonary regurgitation; RVOT; transcatheter pulmonary valve
The Harmony TPV device shows favorable clinical and hemodynamic outcomes in the treatment of pulmonary regurgitation.
BACKGROUND The Harmony transcatheter pulmonary valve (TPV) is the first U.S. Food and Drug Administration- approved device for severe pulmonary regurgitation (PR) in the native or surgically repaired right ventricular outflow tract (RVOT).OBJECTIVES One-year safety and effectiveness of the Harmony TPV were evaluated in patients from the Harmony Native Outflow Tract Early Feasibility Study, Harmony TPV Pivotal Study, and Continued Access Study, representing the largest cohort to date of Harmony TPV recipients.METHODS 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 (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 mmHg, 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 Harmony TPV device demonstrated favorable clinical and hemodynamic outcomes across studies and valve types through 1 year. Further follow-up will continue to assess long-term valve performance and durability. (J Am Coll Cardiol Intv 2023;16:1917-1928)(c) 2023 The Authors. Published by Elsevier on behalf of the American College of Cardiology Foundation. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/ licenses/by-nc-nd/4.0/).
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