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J Thorac Cardiovasc Surg 2005;129:1446
© 2005 The American Association for Thoracic Surgery


Brief Communication

Acute leaflet arrest in St Jude Medical Regent aortic valve

Eivind Øvrum, MD, PhD*, Geir Tangen, MD

Oslo Heart Center, National Hospital, Oslo, Norway.

Received for publication January 11, 2005; accepted for publication February 8, 2005.

* Address for reprints: Eivind Øvrum, MD, PhD, Oslo Heart Center, Box 2684, St Hanshaugen 0131 Oslo, Norway (Email: eivind.ovrum{at}hjertesenteret.no).

Manufacturers of mechanical heart valves have, during the last years, modified previous versions, particularly the prostheses for the aortic position. Most efforts have been made to optimize the size by changing the original design for intra-annular implantation toward placement of the valve in a supra-annular position. The SJM Regent valve (St Jude Medical, Inc) is such a modification and is redesigned for supra-annular implantation by constructing a supra-annular cuff and shifting the carbon rim to a supra-annular design. The intention is to have a greater geometric orifice area within a given tissue annulus dimension. This effect has been proved for other mechanical valves, by increasing the prosthesis size in small aortic ostia1

In the hands of senior cardiac surgeons performing numerous aortic valve replacements (AVRs) per year, 3 patients had their prostheses explanted immediately during the operation as a result of leaflet arrest. The prostheses were replaced with a smaller-sized valve of the same type in 1 patient and CarboMedics (CM) valves of similar size in 2 instances. After explantation, there were no signs of any mechanical dysfunction of the prostheses, confirming the in vivo tissue entrapment and subsequently locking the leaflets.

Clinical Summaries

Patient 1
A 58-year-old man (height, 180 cm; weight, 76 kg) was admitted for AVR caused by aortic stenosis. A severely calcified bicuspid valve was removed. After proper decalcification and routine measurement of the annulus, a 25-mm SJM Regent valve was implanted with Ti-Cron 2-0 mattress sutures, with Teflon pledgets on the ventricular side. The prosthesis was tied down without difficulties. However, on testing the opening of the valve, the leaflets were completely arrested, and rotation was impossible. By forceful opening, subvalvular tissue was seen bulging into the hinge mechanism. The prosthesis was removed and replaced with a 23-mm SJM Regent valve by the same technique as in the first case. The postoperative course was uneventful.

Patient 2
A 64-year-old man (height, 180 cm; weight, 74 kg) with aortic insufficiency was admitted for AVR. There was no calcification of the aortic annulus, and after proper sizing of the annulus, a 27-mm SJM Regent valve was chosen. An identical technique as that used in patient 1 was used. The pulling down of the prosthesis into the aortic ring was easy; however, the leaflets were unmovable, and rotation of the prosthesis was impossible. The valve was removed and replaced with a 27-mm CM Standard valve by use of the same technique for implantation. Apart from revision for bleeding a few hours postoperatively, there were no complications.

Patient 3
A 65-year-old man (height, 185 cm; weight, 126 kg) with angina and diabetes and aortic stenosis was admitted. The aortic valve was moderately calcified, and after proper debridement and measurement of the annulus, a 25-mm SJM Regent was implanted. A similar technique as for the 2 previous cases was used. After testing, the leaflets were unable to be opened, and rotation of the housing was not successful. By pressing the leaflets apart, subvalvular tissue was seen in the hinges, hindering free movement. The prosthesis was removed and replaced with a 25-mm CM Standard valve by using an identical technique of implantation. There were no postoperative complications.

Discussion

The SJM Regent valve is a modification of the standard prosthesis designed to optimize the anatomic area by lifting some part of the housing and sewing ring to a more supra-annular position. However, as for the standard valve, the pivot mechanism with its ears has still to be placed inside and below the aortic annulus. The entrapment of the subvalvular tissue into the hinge, thereby arresting the leaflet movements, was much unexpected and extremely unpleasant, particularly in a situation of completely routine AVR. Attempts to rotate the valves were also unsuccessful as a consequence of the tissue entrapment into the hinges. The particular rotation mechanism of the SJM valves might have added to the problem. The leaflet hinges slide against tissue of the aortic annulus and not inside a metal housing, as in other bileaflet valves.

In a multicenter study2 the hemodynamic performance and clinical results of the SJM Regent aortic valve were reported to be excellent. No dysfunction or leaflet restriction was mentioned. However, it is widely known that operative difficulties and technical problems are underreported. In another article published recently, 2 cases similar to ours were reported, although another version of the SJM valve was used.3 Therefore, we find it justified to share our unpleasant incidents with other cardiac surgeons.

References

  1. Lundblad R, Hagen OM, Smith G, Kvernebo K. The CarboMedics supraannular top hat valve improves prosthesis size in the aortic root. J Heart Valve Dis 2001;10:196-201.[Medline]
  2. Bach DS, Goldbach M, Sakwa MP, Petracek M, Errett L, Mohr F, et al. Hemodynamics and early performance of the St. Jude Medical Regent aortic valve prosthesis. J Heart Valve Dis. 2001;10:436-442.[Medline]
  3. Grattan MT, Thulin LI. Leaflet arrest in St. Jude Medical and CarboMedics valves. an experimental study. Eur J Cardiothorac Surg. 2004;25:953-957.[Abstract/Free Full Text]



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