North American single-center experience with a sutureless aortic bioprosthesis

Abstract Objective Surgical sutureless aortic valves have the potential for shorter procedural times and could benefit patients with increased risk. The Enable (Medtronic Inc, Minneapolis, Minn) valve is a bioprosthesis housed in a Nitinol cage allowing folding and deployment once implanted. We aime...

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Published in:The Journal of thoracic and cardiovascular surgery 2016-03, Vol.151 (3), p.735-742
Main Authors: de Varennes, Benoit, MD, Lachapelle, Kevin, MD, Cecere, Renzo, MD, Szczepkowski, Isabel, RN, Buithieu, Jean, MD
Format: Article
Language:English
Subjects:
Aged
Aged, 80 and over
Alloys
aortic valve
Aortic Valve - diagnostic imaging
Aortic Valve - physiopathology
Aortic Valve Stenosis - diagnosis
Aortic Valve Stenosis - mortality
Aortic Valve Stenosis - physiopathology
Aortic Valve Stenosis - therapy
Bioprosthesis
Cardiac Catheterization - adverse effects
Cardiac Catheterization - instrumentation
Cardiac Catheterization - mortality
Cardiothoracic Surgery
Echocardiography, Doppler, Color
Female
Heart Valve Prosthesis
Heart Valve Prosthesis Implantation - adverse effects
Heart Valve Prosthesis Implantation - instrumentation
Heart Valve Prosthesis Implantation - mortality
Hemodynamics
Humans
Male
Middle Aged
Prosthesis Design
Quebec
Retrospective Studies
Risk Assessment
Risk Factors
surgery
Suture Techniques
sutureless
Time Factors
Treatment Outcome
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Summary:Abstract Objective Surgical sutureless aortic valves have the potential for shorter procedural times and could benefit patients with increased risk. The Enable (Medtronic Inc, Minneapolis, Minn) valve is a bioprosthesis housed in a Nitinol cage allowing folding and deployment once implanted. We aimed to evaluate the early clinical and echocardiographic results with the Enable valve. Methods Patients with aortic stenosis, Society of Thoracic Surgeons score greater than 5.0%, the need for combined procedures, and frailty were considered for Enable implantation. Results Between August 2012 and October 2014, 63 patients underwent implantation of the Enable valve (Medtronic Inc, Minneapolis, Minn). Thirty patients underwent isolated aortic valve replacement. Combined procedures were aortic valve replacement/coronary artery bypass grafting (26), aortic valve replacement/mitral valve repair (2), aortic valve replacement/mitral valve repair/coronary artery bypass grafting (2), and aortic valve replacement/ascending aortic graft (3). Predicted Society of Thoracic Surgeons score was 8.06 ± 7.73 (0.94-41.30). Implant success was 100%. Mean crossclamp time for isolated aortic valve replacement was 44 ± 14 minutes (30-91). Thirty-day mortality was 1.6% (1/63), and late mortality was 3.2% (2/62). No mortality was valve related. Intraoperative need for revision was 6.3% (4/63). Early migration requiring reoperation occurred in 1.6% of patients (1/63). Postoperative indexed aortic valve area was 1.08 ± 0.22 cm2 ∕m2 , and peak and mean gradients were 17 ± 7 mm Hg and 9 ± 4 mm Hg, respectively. The rate of complications was as follows: pacemaker 3.1% (2/63), transient ischemic attack 1.6% (1/63), other thromboembolic events 0%, bleeding 0%, and endocarditis 0%. Mean follow-up was 10 ± 8 months. At latest follow-up, 61 patients were in New York Heart Association class I. Moderate or severe aortic regurgitation did not develop in any patients in the follow-up period. Conclusions The Enable bioprosthesis is an acceptable alternative to conventional aortic valve replacement in higher-risk patients. The early hemodynamic performance seems favorable.
ISSN:0022-5223
1097-685X
DOI:10.1016/j.jtcvs.2015.10.064