Use of Oversized Injectable Valves in Growing Children for Total Repair of Right Ventricular Outflow Tract Anomalies (Preliminary Results)

Abstract

B ecause congenital anomalies of the right side of the heart are often characterized by a wide spectrum of right ventricular outflow tract (RVOT) and pulmonary valve (PV) alterations, the RVOT and PV are frequently involved in pediatric cardiac surgery. Nevertheless, the PV remained neglected for a very long time; it has gained consideration only in recent years.The first surgical corrections involved ventricular septal defect (VSD) closure and RVOT enlargement with a simple transannular patch, without attention to the PV. Emphasis on short-term results led incorrectly to the idea that the PV had no significance. The belief that "no valve is better than a stenotic valve" induced surgeons to leave many RVOTs unvalved.1-3 When long-term follow-up results became available, it became clear that unvalved patients could develop pulmonary artery dilation and right ventricular (RV) failure, 4-7 which led to additional valve procedures. A new idea-that "a working valve is better than no valve"-then arose, and valve preservation gradually became a must in tetrology of Fallot (TOF) treatment. For this reason, much surgical effort in dealing with an altered RVOT is today directed toward sparing the valve whenever possible. 3,8,9 Unfortunately, valve-sparing is often difficult and sometimes impossible. When the valve is atretic or very narrow, there is no doubt that the only solution is a transannular patch.10 On the other hand, when pulmonary diameter is acceptable or good, the valve often presents alterations: it is bicuspid, has leaflet tethering, leaflet thickening, commissural fusion, etc. 11,12 Repairing the valve is not as easy as it sounds. When the anatomic defects are substantial, the results of repair can be unsatisfactory or outright

No-React® Injectable BioPulmonic™ Valves Re-evaluated: Discouraging Follow-up Results

“…These obstacles for an interventional valve-in-valve procedure were the reason for the need for surgery in three patients. Deorsola and Abbruzzese [6] found this prosthesis very helpful in young children. From our experience, we cannot support their judgement.…”

“…The No-React® Injectible valve was introduced as a modern surgical valve replacement for minimally invasive and even off-pump procedures [1][2][3][4][5][6]. The potential advantages were ease of implantation, favourable tissue constitution and a perfect landing zone for a percutaneous valve-in-valve.…”

“…The No-React® Injectable BioPulmonic™ valve (BioIntegral Surgical, Inc., Mississauga, ON, Canada) was introduced almost 10 years ago as a helpful tool for minimally invasive off-pump replacement of the pulmonary valve [1,2]. The acute and initial results were encouraging [1][2][3][4][5], and have been recently updated by another short-term series [6]. We carefully followed our patient cohort to evaluate the mid-to long-term performance of this stented type of No-React® valve.…”

Off-pump injectable versus on-pump conventional tissue valves for pulmonary valve replacement: the injectable valve implantation randomised trial (INVITE)

“…Case reports and small pilot studies have reported that IPVs are easy to implant and have satisfactory function 1–9. However, when the Injectable Valve Implantation Trial (INVITE) was designed, no randomised controlled trial (RCT) had been conducted to evaluate valve replacement with IPV.…”

Echocardiographic Assessment after Surgical Repair of Tetralogy of Fallot

“…However, pulmonary valve-preserving repair in patients with severe hypoplastic pulmonary valves remains challenging and controversial ( 5 , 6 ). Deorsola and colleagues proposed the preliminary results of an innovative procedure consisting in the implant of an injectable biological pulmonary valve, designed for right infundibular surgery in adults; in babies: the valves, shrunken to a smaller diameter, enable the implantation of a device wider than otherwise possible in young patients and once in the pulmonary position tends to expand to its original size following patient’s growth ( 7 ).…”