Convexo-concave Prosthesis Research Articles

Radiographic assessment of structural defects in Björk-Shiley convexo-concave prostheses.

Following the implantation of Björk Shiley 60 degrees convexo-concave (BS-CC) prostheses, outlet strut fracture rates up to 2.5% per year have been reported. According to experimental results and clinical observations, single leg separations are regarded as the primary mechanisms leading to complete outlet strut fracture after a certain interval. In an experimental study the question was addressed, whether single leg separation can be identified by especially developed radiographic means, before outlet strut fracture occurs. Five BS-CC mitral prostheses (29-31 mm) with intentionally made single leg separations of defined gas sizes (0-75 microns) and one intact mitral prostheses were implanted in sheep in a double-blind study design. Repeat non-invasive investigations were then performed applying a recently developed fluoroscopy imaging technique with direct radiographic magnification (DIMA COR C22). Single leg separations with gap sizes of more than 25 microns were properly detected using DIMA COR C22. Separations 25 microns or less could not be detected with certainty but were evaluated as probable or possible as a result of multiple investigations. The intact prosthesis was correctly identified, but was investigated on only one occasion. Non-invasive control of Björk-Shiley CC mitral prostheses applying especially developed direct radiographic magnification may allow for a reliable assessment of single leg separation with gap sizes of more than 25 microns in sheep. Using this technique of non-invasive serial investigations on particular patients with high probability of outlet strut fracture appears feasible, anticipating single leg separation detectability in humans. This has to be assessed in a second step.(ABSTRACT TRUNCATED AT 250 WORDS)

Elective removal of convexe-concave Björk-Shiley valves

Replacement has been an accepted method for treating advanced cardiac valvular disease for more than 25 years. However, the perfect prosthesis has yet to be developed, judging by the number of devices available. A prosthesis that initially appears promising may cause problems in due course, and indeed some devices have been modified or withdrawn from clinical use. A notable example of a prosthetic valve that has given problems is the Björk-Shiley convexo-concave prosthesis, some models of which have undergone mechanical failure due to strut fracture. We report the elective removal of such a valve and the subsequent examination of the prosthesis. The results of this examination suggest that a policy of elective removal is justified.

Five-year results after valve replacement with the Björk-Shiley 70 degrees convexo-concave prosthesis.

In the 18 months up to July 1983, 120 Björk-Shiley convexo-concave prostheses with 70 degrees opening angle were implanted in 47 women and 61 men aged 19-78 (mean 58.6) years. The prosthetic valves were aortic in 65 cases, mitral in 23 and both aortic and mitral in 20 cases. Emergency operation was required in ten cases, and concomitant surgery was performed in 43 (39.8%). The early mortality was 5.5%. A follow-up study, comprising 498 patient years, revealed 73.1% 5-year survival. There were three mechanical failures of prosthesis, in one of which re-replacement was successful. Elective prosthesis replacement was performed in four other cases judged to be at high risk of strut fracture.

Björk-Shiley strut fracture and disc escape: Literature review and a method of disc retrieval

Embolization of a prosthetic valve poppet is a rare but life-threatening event. It was reported sporadically before the introduction of the Björk-Shiley 70-degree convexoconcave prosthesis in 1980. Since that time, there have been a large number of reported mechanical failures with disc escape. The rate for the 29-mm to 33-mm mitral valves is estimated as 5.2%. In 29 of 35 patients (including the 2 presented here) in whom the site of disc lodgment could be determined, the disc was in the descending or abdominal aorta. Fifteen of these patients died. Six survivors had the disc removed at the same operation and 6 at a later operation. In 2 patients, the disc was not removed. In 2 patients in whom the disc was not removed initially, it was thought to contribute to post-operative complications. Two more cases of structural failure of the Björk-Shiley convexoconcave prosthesis are presented. A transpericardial approach to the descending aorta on bypass is described. It allows easy removal of the disc and eliminates the need for a second operation.

Fourteen years’ experience with the Björk-Shiley tilting disc prosthesis

Between 1970 and 1984, 1,574 Björk-Shiley valve prostheses have been implanted in 1,171 patients in Glasgow. Between 1970 and 1980, 1,023 standard disc prostheses were implanted in 729 patients: 184 had aortic valve replacement, 323 mitral, and 222 multiple valve replacement. Between 1980 and 1984, 551 convexo-concave valves were implanted in 442 patients: 125 had aortic, 228 mitral, and 89 multiple valve replacement. Concomitant coronary artery bypass grafting was performed in 9.2% of the latter group as compared with 2.7% of the earlier group. The overall hospital (30 day) mortality for the group with the standard disc prosthesis was 10.4% and for patients with the convexo-concave prosthesis, 7.0%. Cumulative follow-up extends to 4,125 patient-years--standard disc group 3,378 patients-years, range 4 to 14 years (mean 5.2 years); convexo-concave group 747 patient-years, range 1.5 to 5.3 years (mean 1.9 years). The late mortality is 3.8% per patient-year--standard disc group 2.9% per patient-year and convexo-concave group 4.3% per patient year (no significant difference). Actuarial survival rate at 12 years for the whole group, excluding operative deaths, is 69.4% +/- 6.3%. The freedom from all valve-related complications at 12 years is 65.9% +/- 6.5%. there is no significant difference in the incidence of most major complications between the standard disc and convexo-concave prostheses apart from the occurrence of mitral valve thrombosis (p less than 0.05) in the standard disc group and outlet strut fracture (p less than 0.005) in the convexo-concave group. These results confirm the excellent long-term performance of the Björk-Shiley tilting disc prosthesis.

Early Results of Valve Replacement with the Björk-Shiley Convexoconcave Prosthesis

The Björk-Shiley convexoconcave prosthetic valve has design characteristics that may result in a lower incidence of thromboembolic complications than the conventional spherical Björk-Shiley prosthesis. We evaluated the results of valve replacement with the convexoconcave prosthesis in 248 patients receiving 301 prosthetic valves between March, 1979, and June, 1981. One hundred thirteen patients had aortic valve replacement (AVR), 73 had mitral valve replacement (MVR), and 62 had multiple valve replacement. Two hundred nine (84%) were in New York Heart Association Class III or IV. The median duration of follow-up was 13 months, and follow-up information was available for 246 (99%) of the patients. The actuarial incidence of freedom from thromboembolism at two years was 98% in the AVR group, 97% in the MVR group, and 87% in the group having multiple valve replacement. There were no documented episodes of valve thrombosis or mechanical failure and no fatal thromboembolic complications. The absence of valve thrombosis is in marked contrast to the results reported with the spherical disc valve. Although longer follow-up is necessary, it appears that the convexoconcave design represents a major improvement in the Björk-Shiley prosthesis.

Haemodynamic evaluation of the convexo-concave Björk-Shiley prosthesis in patients with narrow aortic annulus.

A late haemodynamic re-evaluation at rest and during exercise was performed in 22 patients with isolated aortic valvular disease and narrow aortic annulus, operated upon with the convexo-concave Björk-Shiley prosthesis. The 21 mm prosthesis had been inserted in 11 patients and the 23 mm one in the other 11 patients. Left ventricular pump function improved and was normalized in half of the patients. The mean systolic pressure difference across the 21 mm convexo-concave prosthesis was 16.2 +/- 8.1 mmHg at rest and 20.7 +/- 7.9 mmHg during exercise (32 +/- 10 watts). It was 14.9 +/- 6.0 mmHg at rest and 18.6 +/- 6.3 mmHg during exercise (34 +/- 156 watts) across the 23 mm convexo-concave prosthesis. Compared with the earlier investigated standard model Björk-Shiley prosthesis, the 21 mm convexo-concave version creates a lower resistance to blood flow (less than 0.01), whereas no such difference could be demonstrated in the two models of 23 mm tissue diameter. It was concluded that the new convexo-concave tilting disc valve constitutes an improvement over the standard model in the management of the narrow aortic annulus permitting insertion of a 21 mm prosthesis.

Comparison between theIn VitroFlow Dynamics of the Standard and the Convexo-Concave Björk-Shiley Tilting Disc Valve Prostheses

In the new convexo-concave model of the Björk-Shiley prosthesis the disc pivots 2.5 mm downstream, creating a space between the disc and the ring when the disc tilts open. Its flow dynamics were compared with those of the standard model under steady flow rates 0--32 1/min of a water-glycerin mixture employed as blood-analogous test fluid. The following results are valid for corresponding sizes of the conventionally used 21, 23, 25, 27, 29 and 31 mm prosthetic valves of the two models. The transprosthetic pressure fall varied directly, but in a parabolic fashion with the steady flow rate for all the partial and full flow orifices. The resistance to flow 0--32 1/min for the full flow orifice of the convexo-concave prosthesis was in average 16% lower than that of the standard model, with highly significant differences for the 21 and 23 mm prostheses (p less than 0.001). There was a redistribution of flow towards the smaller prosthetic opening from 23% (S.D. +/- 1.4) for the standard model to 30% (S.D. +/- 2.4) for the convexo-concave model (p less than 0.001). The minimum steady flow rate required to maintain the convexo-concave disc in completely open position (60 ml/sec) was only half that (37--50%) required for the standard disc (125 ml/sec) (p less than 0.001). Regurgitation through the closed prosthesis varied directly and linearly with the driving pressure and was slightly but definitely lower with the convexo-concave model than with standard model. The main features of the new design are decreased resistance to flow, redistribution of the flow within the prosthesis in order to prevent stasis along its smaller orifice, diminished opening resistance and reduced regurgitation. It is concluded that the flow dynamics of the convexo-concave model Björk-Shiley prosthesis constitute a significant improvement over those of the standard model.