Key result
The Perceval S sutureless valve significantly increased postoperative effective orifice area (1.5 vs 1.1 cm2, p=0.002) and reduced ischemia time (40 vs 86 min, p<0.001) compared to a conventional stented bioprosthesis in elderly patients with small aortic roots.
Why the study?
Does sutureless Perceval S valve implantation improve effective orifice area and reduce operation times compared to conventional stented bioprosthesis in elderly patients with severe aortic stenosis and small aortic root?
RCT (n=50)
computerized assisted mathematic model
No
Does sutureless Perceval S valve implantation improve effective orifice area and reduce operation times compared to conventional stented bioprosthesis in elderly patients with severe aortic stenosis and small aortic root?
Absolute Event Rate: 1.5% vs 1.1%
p-value: p=0.002
In elderly patients with severe aortic stenosis and a small aortic root, the sutureless Perceval S valve significantly reduced operation times and improved effective orifice area compared to a conventional stented bioprosthesis, avoiding patient-prosthesis mismatch.
Supports sutureless Perceval S in elderly small-root patients to improve hemodynamics and shorten ischemia; extends RCT evidence for sutureless valves in this population.
BACKGROUND: The aim of this study is to see how the sutureless, stentless, Perceval S aortic valves behave when implanted in elderly patients with small aortic root and the comparison with a second group of patients with similar characteristics where a conventional stented bioprosthesis was implanted. This is a prospective randomized institutional study. METHODS: Our material is composed from 25 patients who underwent aortic valve replacement with sutureless self-anchoring Perceval S valve implantation (LivaNova), compared with 25 patients with conventional stented biological prosthesis implanted (soprano LivaNova group). The two groups of patients have similar demographic and medical characteristics with severe aortic stenosis. The study was conducted from January 2012 to June 2014. Preoperative, intraoperative and postoperative parameters were studied in order to investigate the utility of the Perceval S valves in this group of patients. RESULTS: The Perceval S valve implantation seems to be an interesting biological valve with good hemodynamic characteristics as compared with the typical biological prosthesis providing shorter ischemia time (40 ± 5.50 min vs 86 ± 15.86 min; p < 0.001), shorter extracorporeal circulation time (73.75 ± 8.12 min vs 120.36 ± 28.31 min p < 0.001), less operation time (149.38 ± 15.22 min vs 206.64 ± 42.85 min; p < 0.001) and better postoperative recovery. The postoperative gradients were 23.5 ± 19.20 mmHg vs 24.5 ± 19.90 mmHg respectively. The postoperative effective orifice area in these two groups were respectively 1.5 =/-0.19 cm(2) vs 1.1=/-0.5 cm(2) (p 0.002). Among the 25 patients of the Soprano stented valve, 3 (12 %) came back in 6 months with New York Heart Association (NYHA) 3. The PPM of these patients was the cause of readmission in the Hospital required diuresis and supplementary treatment. CONCLUSIONS: Aortic valve replacement with Perceval aortic valves in geriatric patients with comorbidities and small aortic annulus seems to be an alternative, safe and "fast" intervention with excellent short and mid-term results which provides a better effective orifice area.
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Dedeilias et al. (2016) conducted an RCT in severe aortic stenosis (n=50). Perceval S sutureless valve vs. Soprano conventional stented biological prosthesis was evaluated on Postoperative effective orifice area (EOA) (p=0.002). The Perceval S sutureless valve significantly increased postoperative effective orifice area (1.5 vs 1.1 cm2, p=0.002) and reduced ischemia time (40 vs 86 min, p<0.001) compared to a conventional stented bioprosthesis in elderly patients with small aortic roots.
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