Aortic valve replacement using Perceval S bioprothesis
Abstract
Aim. А multicenter, prospective, nonrandomized, clinical trial was developed to assess the efficacy and safety of the sutureless aortic bioprosthesis Perceval S in the surgical treatment
of aortic valve injury in the elderly patients. Clinical and echocardiographic observation
was carried out at the hospital stage and after discharge from the hospital in 3, 6, 12, 24
and 36 months.
Methods. The valve was implanted through sternotomy, on CPB and after removal of the native
valve. The valve was implanted without suturing. Optimum fitting in the aortic position was provided by balloon adaptation at low pressure. If CABG or any valve surgery was also required, the
combined procedures were performed first. In the period from 2013 to 2017, 51 patients were
operated (mean age 71±12 years). Isolated aortic stenosis was found in 90%, and insufficiency
in 10% cases. The average EuroSCORE was 13.18%, and the III–IV functional class by NYHA
was 93.3% and 6.7% respectively. The sizes of the implanted valves were 21, 23 and 25 mm.
20 (40%) patients underwent CABG, in some cases with MV plasty. 6% – MV plasty only.
Results. Mean cross clumping time and CPB time was 31±12 and 59±18 min respectively. 1 (12%)
case of hospital non-valve related mortality was detected. In the long-term (up to 36 months)
follow-up there were no deaths. A total of 42 patients were evaluated at 3, 6, 12, 24 and 36 months
after implantation. There were no cases of valve migration. The cases of conduction disturbance
that required the pacemaker installation were not observed during the entire observation period.
Conclusion. The preliminary results of the study confirm the safety and effectiveness of the su-
tureless aortic valve bioprosthesis Perceval S. In the group of moderate and high risk patients,
reduction of CPB and cross-clamping time, as well as a significant reduction of well-known
complications of aortic valve replacement can help reduce mortality and morbidity of mid- and
long-term outcomes. The sutureless technique could be a promising alternative to biological
aortic valve replacement.
Keywords:aortic valve replacement, sutureless heart valve prosthesis, prospective study, Perceval S
Clin. Experiment. Surg. Petrovsky J. 2017; 5 (4): 30–6.
Received: 14.09.2017. Accepted: 10.10.2017.
References
1. Santarpino G., Pfeiffer S., Concistre G., Fischlein T. Perceval
S aortic valve implantation in mini-invasive surgery: the simple
sutureless solution. Interact Cardiovascul Thorac Surg. 2012;
15: 357–60.
2. Cribier A., Eltchaninoff H., Bash A., et al. Percutaneous
transcatheter implantation of an aortic valve prosthesis for calcific
aortic stenosis: first human case description. Circulation. 2002;
106: 3006–8.
3. Grube E., Laborde J.C., Zickmann B., et al. First report on
a human percutaneous transluminal implantation of a self-expanding
valve prosthesis for interventional treatment of aortic valve stenosis.
Catheter Cardiovasc Interv. 2005; 66: 465–9.
4. Hanzel G.S., Harrity P.J., Schreiber T.L., O’Neill W.W.
Retrograde percutaneous aortic valve implantation for critical aortic
stenosis. Catheter Cardiovasc Interv. 2005; 64: 322–6.
5. Walther T., Falk V., Borger M.A., et al. Minimally invasive
transapical beating heart aortic valve implantation: proof
of concept. Eur J Cardiothorac Surg. 2007; 31: 9–15.
6. Walther T., Simon P., Dewey T., et al. Transapical minimally
invasive aortic valve implantation: multicenter experience. Circula-
tion. 2007; 116: I240–5.
7. Webb J.G., Chandavimol M., Thompson C.R., et al.
Percutaneous aortic valve implantation retrograde from the femoral
artery. Circulation. 2006; 113: 842–50.
8. Kraynyukov P.E., Dalinin V.V., Borisov I.A., Afonaskov O.V.
First experience of PERCEVAL S implantation. Voenno-meditsinskiy
zhurnal [Military Medical Journal]. 2016; 337 (8): 28–34 (in Russian)
9. Mehta R.H., Grab J.D., O’Brien S.M., et al. Bedside tool
for predicting the risk of postoperative dialysis in patients
undergoing cardiac surgery. Circulation. 2006; 114: 2208–16.
10. Laborde F., Fischlein T., Hakim-Meibodi K., Misfeld M.,
et al. Clinical and haemodynamic outcomes in 658 patients receiving
the Perceval sutureless aortic valve: early results from a prospective
European multicentre study (the Cavalier Trial). Eur J Cardiothorac
Surg. 2016; 49: 978–86.
11. Shrestha M., Fischlein T., Meuris B., et al. European
multicentre experience with the sutureless Perceval valve: clinical
and haemodynamic outcomes up to 5 years in over 700 patients.
Eur J Cardiothorac Surg. 2016; 49 (1): 234–41.
12. Webb J.G., Pasupati S., Humphries K., et al. Percutaneous
transarterial aortic valve replacement in selected high-
risk patients with aortic stenosis. Circulation. 2007; 116:
755–63.
13. Lichtenstein S.V., Cheung A., Ye J., et al. Transapical
transcatheter aortic valve implantation in humans: Initial clinical
experience. Circulation. 2006; 114: 591–6.