1. Initial center experience with the St
Initial center experience with the St. Jude Trifecta aortic valve prosthesis and Cor-Knot suture fixation device
Karan Sian MBBS, Stuart Sugito BMed, Sheila Li BMed, Ajay I Iyengar MBBS PhD, Ross Mejia FRACS, Peng W Seah FRACS
Department of Cardiothoracic Surgery, John Hunter Hospital, New Lambton, New South Wales, Australia
Corresponding Author: Karan Sian, Department of Cardiothoracic Surgery John Hunter Hospital, 1 Lookout Rd, New Lambton, 2305, NSW, Australia. Tel: ;
INTRODUCTION: The Trifecta valve*is a tri-leaflet stented pericardial valve made for use in the supra-annular aortic position. The Cor-Knot** is a suture fixation device conceived for remote suture tensioning and quick fixation. This study evaluates the initial experience using the Cor-Knot device and early hemodynamic performance of the Trifecta valve.
RESULTS: Concomitant procedures included: mitral valve replacement (2), coronary artery bypass grafting (10) and redo AVR (4). In-hospital mortality at 30 days was 3%(1). Table 2 outlines mean and peak valve gradients per valve size. Cor-Knot demonstrated a mean reduction in total cardio pulmonary bypass and cross-clamp times of (Table 3) however no statistical significance could not be shown. No paravalvular leak or significant aortic regurgitation was demonstrated before discharge. Mean effective orifice valve areas (EOAs) slightly less than those from St. Jude data(1).
METHODS: Twenty-nine patients underwent aortic valve replacement (AVR) between Nov and July 2015 (Table 1). Cor-Knot was used in 40% (11) of patients. Echocardiography was performed prior to discharge from hospital. Linear regression was used to assess influence of Cor-Knot on bypass and cross clamp times***.
Table 2 Echocardiographic data per valve size
Valve Size
21(5)
23(16)
25(7)
27(1)
29(1)
Peak Gradient (mmHg)
/- 5.6
17.4 +/- 6.8
/- 1.9 10 7
Mean Gradient (mmHg)
/- 1.9
9.17 +/- 3.8
8.77+/-1.4 NR
Number of patients given in parentheses
CONCLUSIONS: Initial clinical experience and early hemodynamic values of the Trifecta valve are promising. The Cor-Knot has simplified the securement of the bioprosthesis to annulus, no paravalvular leak was demonstrated.
Further studies with larger patient cohorts will be required to demonstrate a significant benefit in the reduction of bypass and cross-clamp times when using Cor-Knot.
REFERENCES:
1. Permanyer E, Estigarribia AJ, Ysasi A, Herrero E et al. St. Jude Medical Trifecta aortic perioperative performance in 200 patients. Interact CardioVasc Thorac Surg 2013;17:
Table 1 Baseline Patient Characteristics
Variables
Overall (n=29)
Age, mean +/- SD
/- 7.07
Sex, female (%)
7 (24.14)
BSA, mean +/- SD (m2)
2.01 +/-0.21
BMI, mean +/- SD (kg/m2)
/- 6.19
Hypertension (%)
23 (79.31)
Diabetes Mellitus (%)
10 (34.48)
COPD (%)
3 (10.34)
Hyperlipidaemia (%)
20 (68.97)
Creatinine, mean +/- SD (mg/dl) /
Peripheral vascular disease (%)
1 (3.45)
Atrial Fibrillation (%)
EuroSCORE, mean +/- SD (%)
2.53 +/- 1.41
*St. Jude Medical Inc., St. Paul, MN, USA
**LSI Solutions, Victor, NY, USA
***IBM Corp. Released IBM SPSS Statistics for Windows, Version Armonk, NY: IBM Corp.