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Ann Thorac Surg 2008;86:1466-1472. doi:10.1016/j.athoracsur.2008.06.085
© 2008 The Society of Thoracic Surgeons
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Stefano M. Marianeschi
Francesco Santoro
Elena Ribera
Hasim Ustunsoy
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Right arrow Valve disease

Original Articles: Adult Cardiac

Pulmonary Valve Implantation With the New Shelhigh Injectable Stented Pulmonic Valve

Stefano M. Marianeschi, MDa,*, Francesco Santoro, MDa, Elena Ribera, MDa, Emanuele Catena, MDa, Gabriele Vignati, MDa, Simone Ghiselli, MDa, Stefano Pedretti, MDa, Ozkan Suleyman, MDb, Hasim Ustunsoy, MDc, Pascal A. Berdat, MDd

a Pediatric Cardiology, Anesthesiology, MR Unit and Cardiac Surgery, Niguarda Hospital, Milan, Italy
b Department of Cardiovascular Surgery, Baskent University Hospital, Ankara, Turkey
c Department of Cardiovascular Surgery, Gaziantep University Medical School, Gaziantep, Turkey
d Cardiovascular Center Zurich, Clinic Im Park, Zurich, Switzerland

Accepted for publication June 13, 2008.

* Address correspondence to Dr Marianeschi, Niguarda Hospital, Piazza Ospedale Maggiore 3, 20162, Milan (Email: marianeschi{at}hotmail.com).

Presented at the Forty-fourth Annual Meeting of The Society of Thoracic Surgeons, Fort Lauderdale, FL, Jan 28–30, 2008.

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.






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