Materials and Methods

Due to this study’s retrospective nature, the need for informed consent was waived by our institutional review board (IRB).
Patients
We performed a retrospective review of patients undergoing aortic cusp extension valvuloplasty at a large, urban academic medical center between April 2009 to July 2016. Patients receiving CorMatrix, either patch or membrane, were compared to those receiving autologous pericardium irrespective of glutaraldehyde time.
Data Collection
We collected the following baseline characteristics: age, previous operation, aortic valve anatomy, CPB time, and cross clamp time for all patients. Clinical data such as echocardiography and cardiovascular function were reviewed to determine the severity of aortic stenosis (AS) and aortic regurgitation (AR) at baseline, post-operatively, and outpatient follow-up between the two groups.
Statistical Analysis
Pre-operative and post-operative echocardiography were compared using the 2-tailed paired t test for peak transvalvular gradient across the AV. Statistical significance was set at P < 0.05. Overall freedom from reoperation was determine by Kaplan-Meier analysis and is expressed as the percentage of patients who remained event free. If patients had multiple re-operations, the number of days to the first re-operation was used for the analysis. If patients had no listed re-operations, it was assumed that the material was alive at the date of censorship.
Surgical Technique
ACEV was performed similarly to previously published techniques, and a midline sternotomy was used in all procedures.2,7,8 For patients receiving autologous pericardium, a segment of autologous pericardium was harvested and treated with buffered glutaraldehyde solution (0.625%). For one patient in 2009, the pericardium was treated with glutalderhyde solution for 10 minutes. However, as our technique evolved in later years, 3 to 2-minute treatment was used, and the pericardium was kept moist with normal saline solution. Further, all CorMatrix patches or membranes were soaked in saline for 10 minutes before implantation per the manufacturer’s recommendation.
Following an oblique aortotomy incision on cardiopulmonary bypass (CPB), the extent of tissue deficiency, the shape, and the irregularities of the free edge are evaluated before the thinning of thickened edges of the cusps. The ACEV technique is then performed using the piece of treated and tailored autologous pericardium or CorMatrix, both of which are fashioned to fit each cusp but slightly oversized in depth (10-15%) and length (up to 25%). The sutures are created using continuous 5-0 or 6-0 polypropylene suture (Prolene; Ethicon Inc, Sommerville, NJ) and are aligned from the cusp’s center towards the commissures.7
The suture line on the pericardial site is marginally wider than that on the cusp site to provide enough depth to the cusp so that the reconstructed cusp free edge is level with the sinotubular bar at the commissures, but more cauded at the center with a generous mural edge. Using transmural pledgeted polypropylene sutures, the commissural ends and the sinotubular bar are suspended at the same level, with particular attention creating a suspension that best provides optimal coaptation, avoids crowding of the subcommissural triangle, and reestablishes normal semilunar appearance of each neocusp.