Pulmonary valve implantation with the new Shelhigh Injectable Stented Pulmonic Valve.
BACKGROUND
Pulmonary regurgitation (PR) occurs frequently after tetralogy of Fallot (TOF) repair, impairing long-term prognosis and necessitating reinterventions. Myocardial damage, invasiveness, and the risks of pulmonary valve replacement (PVR) therefore need to be minimized. The new Shelhigh Injectable Stented Pulmonic Valve (Shelhigh Inc, Union, NJ) allows implantation without cardiopulmonary bypass (CPB) under direct control.


METHODS
Twelve symptomatic patients (age, 21.3 +/- 12.5; range, 5.8 to 53.5 years) with severe PR and progressive right ventricular (RV) dilatation with dysfunction received the Shelhigh valve in sizes 21 (n = 1), 25 (n = 4), 27 (n = 3), 29 (n = 2), and 31 mm (n = 2).


RESULTS
Valve insertion was successful and hemodynamic performance excellent in all: peak systolic gradient, 14.5 +/- 4.6 (range, 10 to 20) mm Hg; mean gradient, 6.3 +/- 1.6 (range, 4 to 8) mm Hg. Four patients underwent concomitant procedures on CPB: one reduction plasty of a dilated main pulmonary artery, two tricuspid valve repairs, and one VSD closure. Early recovery was uneventful. There were no reoperations. During a mean follow-up of 5.4 +/- 4.3 months (range, 0.3 to 10.6 months) echocardiography showed good results, with low gradients and recovered RV function in all. All presented in New York Heart Association functional class 1 at the latest follow-up.


CONCLUSIONS
The Shelhigh valve allows easy PVR without CPB up to large valve sizes, with less invasiveness compared with a conventional approach. Further follow-up is needed to assess its durability and long-term performance.
Marianeschi
Stefano M
SM
Pediatric Cardiology, Anesthesiology, MR Unit and Cardiac Surgery, Niguarda Hospital, Milan, Italy. marianeschi@hotmail.com
Santoro
Francesco
F
Ribera
Elena
E
Catena
Emanuele
E
Vignati
Gabriele
G
Ghiselli
Simone
S
Pedretti
Stefano
S
Suleyman
Ozkan
O
Ustunsoy
Hasim
H
Berdat
Pascal A
PA
D000293:Adolescent; D000328:Adult; D002648:Child; D002675:Child, Preschool; D004452:Echocardiography; D006330:Heart Defects, Congenital / Q000150:complications / Q000601:surgery; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000379:methods*; D006801:Humans; D008875:Middle Aged; D011474:Prosthesis Design; D011664:Pulmonary Valve / Q000000981:diagnostic imaging / Q000601:surgery*; D011665:Pulmonary Valve Insufficiency / Q000209:etiology / Q000601:surgery*; D015607:Stents; D016896:Treatment Outcome