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J Thorac Cardiovasc Surg 2007;133:986-994
© 2007 The American Association for Thoracic Surgery

Evolving Technology

Acute in vivo evaluation of a new stentless mitral valve

^a Department of Thoracic and Cardiovascular Surgery, Cleveland Clinic, Cleveland, Ohio
^b Department of Biomedical Engineering, Cleveland Clinic, Cleveland, Ohio
^c Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio
^d Quantitative Health Sciences, Cleveland Clinic, Cleveland, Ohio.

Received for publication February 7, 2006; revisions received November 8, 2006; accepted for publication November 20, 2006.

^_* Address for reprints: Jose L. Navia, MD, Department of Thoracic and Cardiovascular Surgery/F24, Cleveland Clinic, 9500 Euclid Avenue, Cleveland, OH 44195. (Email: naviaj{at}ccf.org).

Objectives: We have developed a stentless pericardial mitral valve prosthesis in 2 configurations; the purposes of this acute study in sheep were to assess (1) valve design and implant technique; (2) valve performance; and (3) acute effects on postimplant left ventricular function.

Methods: A stentless bovine pericardial bileaflet valve was developed with the intent to preserve annular–papillary muscle continuity. This valve, in 2 configurations—with (n = 5) and without (n = 5) flap chordae—was implanted in 10 sheep (mean weight 73 ± 9 kg). Epicardial echocardiography was performed to assess valve performance. Load-independent left ventricular function was also estimated before implantation (baseline), 1 hour after discontinuing cardiopulmonary bypass (rest), and during dobutamine stimulation using conductance technology.

Results: Implantation was easily accomplished for both configurations. Both configurations had low transvalvular pressure (mean 2.1 ± 1.2 mm Hg at rest; 2.2 ± 1.0 mm Hg with dobutamine stimulation with flap chordae; 1.7 ± 0.5 mm Hg and 1.6 ± 0.3 mm Hg without flap chordae). No mitral regurgitation was observed in 8 sheep, and mild regurgitation was seen in 2 sheep. Compared with baseline, slope of maximum rate of change of left ventricular pressure–end-diastolic volume relation increased with stimulation both with flap chordae (+52 ± 41 mm Hg · s^–1 · mL^–1, P = .0005) and without (+20 ± 12 mm Hg · s^–1 · mL^–1, P = .003).

Conclusions: Both configurations of this newly designed stentless mitral bioprosthesis, which preserves annular–papillary muscle continuity using different novel surgical implantation techniques, demonstrated reliable valve performance, with low transvalvular pressure gradients, minimal regurgitation, and acutely preserved postimplant left ventricular function. Further chronic study is needed to verify these results and evaluate reliability of implantation procedures, biocompatibility, and durability.

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