Survival advantage of stentless aortic bioprostheses (original) (raw)
Related papers
Stentless vs. stented aortic valve bioprostheses: a prospective randomized controlled trial
European Heart Journal, 2007
Aims We sought to assess the haemodynamic profile of the Freedom stentless aortic valve compared with a stented bioprosthesis in a randomized controlled trial using echocardiography. Methods and results Sixty patients (mean age 73 years) undergoing bioprosthetic aortic valve replacement (AVR) were randomized to either Sorin Freedom stentless (n ¼ 31) or Sorin More stented (n ¼ 29) valves. The primary endpoints were left ventricular mass index (LVMI) reduction at 6 and 12-months. We also assessed post-operative effective orifice area index (EOAI), aortic gradient and operative time. There were no significant differences in baseline characteristics. The stentless valve was associated with a lower post-operative gradient [PG 17 (12) vs. 31 (13) mmHg, P , 0.0001] and greater EOAI [1.1 (0.3) vs. 0.8 (0.2) cm 2 /m 2 , P , 0.0001]. A highly significant reduction in LVMI occurred by 6 months in both groups, but LVMI was significantly lower in the stentless group [LVMI 119 (39) vs. 135 (30) g/m 2 , P ¼ 0.05]. However, there was continued regression of left ventricular hypertrophy (LVH) in the stented but not in the stentless group, resulting in no significant difference in LVMI at 12 months [119 (36) vs. 126 (31) g/m 2 , P ¼ 0.42]. Conclusion The use of the Sorin Freedom stentless bioprosthesis for AVR results in lower PG and greater EOA when compared with a Sorin More stented valve. This is associated with earlier regression of LVH.
Interactive cardiovascular and thoracic surgery, 2009
Randomized trials comparing stentless to stented bioprostheses for aortic valve replacement in elderly are scarce. The aim of this study was early and mid-term evaluation of these bioprostheses, with regards to clinical outcome and hemodynamic performance. Between September 1999 and January 2001, 40 patients with aortic stenosis, over the age of 75 years, were randomly assigned to receive either the stented Perimount (n=20) or the stentless Prima Plus (n=20) bioprosthesis. Clinical outcomes, left ventricular mass regression, effective orifice area, ejection fraction and mean gradients were evaluated at discharge, six months, one year and five years after surgery. At five years, there were 5/20 (25%) deaths in the stentless group and 6/20 (30%) deaths in the stented group (all non-valve-related). There was one case of endocarditis in each group, early postoperatively. Overall, a significant decrease in left ventricular mass was found five years postoperatively. However, there was no ...
Ten-Year Outcome After Aortic Valve Replacement With the Freestyle Stentless Bioprosthesis
The Annals of thoracic …, 2005
Background. Stentless aortic bioprostheses offer excellent hemodynamics and potentially improved durability compared with other bioprostheses. The present report describes the clinical and hemodynamic outcomes for the Freestyle aortic root bioprosthesis in a large, multicenter cohort prospectively followed up for 10 years. Methods. A total of 725 patients at 8 centers in North America (668 [92%] aged more than 60 years) were followed up prospectively after aortic valve replacement with the Freestyle stentless bioprosthesis. Implant technique was subcoronary in 509, total root in 178, and root inclusion in 38. Follow-up was 4,488 patient-years (mean 6.2 years/patient). Results. For subcoronary, full root, and root inclusion groups, 10-year actuarial freedom from structural valve deterioration was 97.0% ؎ 2.2%, 96.0% ؎ 4.5%, and 90.9% ؎ 11.2%, respectively; and actuarial freedom from reop-eration was 91.7% ؎ 3.5%, 92.3% ؎ 6.0%, and 92.0% ؎ 10.7%, respectively. Mean pressure gradient at 10 years was 8.9 ؎ 7.9 mm Hg for subcoronary, 7.0 ؎ 4.1 mm Hg for full root, and 10.0 ؎ 11.1 mm Hg for root inclusion groups; effective orifice area was 1.6 ؎ 0.5 cm 2 , 1.6 ؎ 0.6 cm 2 , and 1.7 ؎ 0.5 cm 2 , respectively. Freedom from moderate or more aortic regurgitation at 10 years was good for all three implant groups, but slightly higher for full root (97.7% ؎ 1.6%) compared with subcoronary (87.2% ؎ 2.8%) patients (p < 0.005). Conclusions. The Freestyle stentless aortic root bioprosthesis is a versatile option for aortic valve replacement. Measures of clinical outcomes and prosthesis durability remain excellent through 10 years.
Eight-year results after aortic valve replacement with the freestyle stentless bioprosthesis
Journal of Thoracic and Cardiovascular Surgery, 2004
Objectives: We sought to describe the hemodynamic and clinical outcomes for the Freestyle aortic root bioprosthesis (Medtronic, Inc, Minneapolis, Minn) in a large multicenter cohort prospectively followed for 8 years. Methods: A total of 700 patients (651 [93%] Ͼ60 years of age) at 8 centers in North America were followed prospectively after aortic valve replacement with the Freestyle stentless bioprosthesis; the implant technique was subcoronary in 500, total root in 162, and root inclusion in 38. Follow-up was 3395 patient-years (4.9 Ϯ 2.3 years per patient). Clinical and echocardiographic follow-up was prospectively obtained at yearly intervals. Results: For the subcoronary, total root, and root inclusion groups, actuarial freedom from valve-related death was 96.8% (SE 3.0%), 92.3% (SE 7.7%), and 90.9% (SE 11.2%), respectively, and freedom from structural deterioration was 98.6% (SE 2.0%), 100.0% (SE 0.0%), and 100.0% (SE 0.0%), respectively. Hemodynamics remained excellent at 6 years. Freedom from moderate or more aortic regurgitation was 86.0% (SE 5.1%), 98.7% (SE 3.9%), and 97.3% (SE 6.6%), respectively. Gradients were slightly lower (P ϭ .0009), and the effective orifice area (P ϭ .02) and freedom from aortic regurgitation were slightly higher (P ϭ .03) with total root than subcoronary implantation. Conclusions: The Freestyle stentless aortic root bioprosthesis is a versatile option for aortic valve replacement. Measures of clinical outcomes and prosthesis durability remain excellent in multicenter follow-up through 8 years in a population predominantly older than 60 years at the time of the operation.
Interactive cardiovascular and thoracic surgery, 2007
A best evidence topic in cardiac surgery was written according to a structured protocol. The question addressed was whether a stentless valve is superior to conventional stented valves when tissue aortic valve replacement is performed. Altogether more than 515 papers were found using the reported search, of which 16 represented the best evidence to answer the clinical question. The authors, journal, date and country of publication, patient group studied, study type, relevant outcomes and results of these papers are tabulated. We conclude that stentless valves allow a larger effective orifice area valve to be implanted with a lower mean and peak aortic gradient postoperatively. At six months several studies and a meta-analysis have shown superior left ventricular mass regression in the stentless valve groups. However, by 12 months the stented valve groups catch up in terms of mass regression and this significance disappears. So the 'eminent speaker from the floor', was right ...
Are Stentless Valves Superior to Modern Stented Valves?: A Prospective Randomized Trial
Circulation, 2006
Background— It is presumed that stentless aortic bioprostheses are hemodynamically superior to stented bioprostheses. A prospective randomized controlled trial was undertaken to compare stentless versus modern stented valves. Methods and Results— Patients with severe aortic valve stenosis (n=161) undergoing aortic valve replacement (AVR) were randomized intraoperatively to receive either the C-E Perimount stented bioprosthesis (n=81) or the Prima Plus stentless bioprosthesis (n =80). We assessed left ventricular mass (LVM) regression with transthoracic echocardiography (TTE) and magnetic resonance imaging (MRI). Transvalvular gradients were measured postoperatively by Doppler echocardiography to compare hemodynamic performance. There was no difference between groups with regard to age, symptom status, need for concomitant coronary artery bypass surgery, or baseline LVM. LVM regressed in both groups but with no significant difference between groups at 1 year. In a subset of 50 patien...