Do differences in early hemodynamic performance of current generation biologic aortic valves predict outcomes 1 year following surgery? J Thorac Cardiovasc Surg 2015 Jan;149(1):163-73.e2
Date
12/03/2014Pubmed ID
25439772DOI
10.1016/j.jtcvs.2014.09.027Scopus ID
2-s2.0-84922320132 (requires institutional sign-in at Scopus site) 15 CitationsAbstract
OBJECTIVE: Small early postoperative hemodynamic differences were noted in a randomized comparison of 3 current-generation bioprosthetic aortic valves. Whether these differences persist and influence clinical outcomes 1 year following implantation is unknown.
METHODS: Three hundred adults with severe aortic stenosis undergoing valve replacement were randomized to receive the Epic (St Jude, St Paul, Minn) (n = 99), Magna (Edwards LifeSciences Inc, Irvine, Calif) (n = 100), or Mitroflow (Sorin Biomedica Spa, Saluggio, Italy) (n = 101) bioprostheses. Hemodynamic valve performance was examined by echocardiography at 1 year, and clinical outcomes were assessed in 241 patients (79 Epic, 77 Magna, and 85 Mitroflow; P = .437).
RESULTS: Mean age was 75 ± 8 years and 164 were men (68%). Between dismissal and 1 year there were 9 deaths (3.7%) (Epic: 3.7%, Magna: 5.0%, and Mitroflow: 2.3%; P = .654), 6 episodes of heart failure (2.5%) (Epic: 1.3%, Magna: 1.3%, and Mitroflow: 5.8%; P = .265), 27 instances of atrial fibrillation/flutter (11.2%) (Epic: 8.1%, Magna: 11.0%, and Mitroflow: 7.9%; P = .577) and no strokes/transient ischemic attacks. One-year echocardiography demonstrated small hemodynamic differences between Epic, Magna, and Mitroflow bioprostheses in mean gradient (15.2 ± 5.5, 12.3 ± 4.3, and 16.2 ± 5.7 mm Hg, respectively; P < .001) and indexed aortic valve area (0.93 ± 0.28, 1.04 ± 0.28, and 0.96 ± -0.26 cm(2)/m(2), respectively; P = .015). Several early trends persisted when stratifying data by echocardiographic annulus diameter, universal annulus size, and implant size, particularly with annular size ≥23 mm. Overall left ventricular mass index regression between dismissal and 1 year was -16.5 ± 28.1 g/m(2), and was similar among groups (P = .262). There were no aortic valve reoperations.
CONCLUSIONS: Despite midterm persistence of small hemodynamic differences amongst current-generation porcine and pericardial aortic valves, our prospective randomized comparison reveals that clinical outcomes and mass regression are equivalent between devices at 1 year. These encouraging trends must continue to be assessed during longitudinal follow-up.
Author List
Thalji NM, Suri RM, Michelena HI, Greason KL, Dearani JA, Daly RC, Joyce LD, Stulak JM, Burkhart HM, Li Z, Schaff HVMESH terms used to index this publication - Major topics in bold
AgedAged, 80 and over
Aortic Valve
Aortic Valve Stenosis
Bioprosthesis
Female
Heart Valve Prosthesis
Heart Valve Prosthesis Implantation
Hemodynamics
Humans
Male
Minnesota
Postoperative Complications
Prospective Studies
Prosthesis Design
Risk Factors
Severity of Illness Index
Time Factors
Treatment Outcome
Ultrasonography
