Porcine Bioprosthetic Valves Research Articles

Estudo multicêntrico da bioprótese porcina Labcor

No período de 1984-1988, foram estudados 514 pacientes, 288 do sexo feminino e 226 do sexo masculino, com idade de 36,8 ± 16,5 anos, submetidos a cirurgia cardíaca valvar com implante de bioprótese porcina Labcor. As cirurgias realizadas foram, em 64%, relativas à valva mitral, 21,5% à aórtica e 2,1 % mitral-aórtica-tricúspide. No período pré-operatório, 1,6% apresentavam-se em classe funcional (NYHA) II, 63,7% classe III e 34,7% classe IV. Após a cirurgia, 77,2% apresentavam-se em classe I, 21,5% classe II, 0,3% classe III e 1,0% classe IV. O tamanho mais utilizado foi o de número 29 (33,3%), seguido do de número 27 (21,7%) e do de número 31 (15,2%); todos os demais apresentaram freqüências inferiores a 10%. Os débitos hospitalares foram da ordem de 7,6% e os tardios, de 3,2%, sendo a letalidade total igual a 10,1 %. O coeficiente de mortalidade foi de 6,3% pacientes/ano. Os sobreviventes foram acompanhados até 4 anos, ocorrendo 13 óbitos tardios, 34% relacionados à prótese. A incidência de complicações que levaram à reoperação para substituição da prótese foi de 17 (3,6%) casos, sendo 2 por endocardite, 1 por calcificação, 4 por vazamento paravalvular e os demais, por outras causas não relacionadas à prótese. Conclui-se que a bioprótese heteróloga Labcor apresentou, no período estudado, até 4 anos de acompanhamento, baixo índice de complicações diretamente relacionadas à válvula (5 de 475 pacientes que sobreviveram à cirurgia.

The Carpentier-Edwards supraannular porcine bioprosthesis: A new generation tissue valve with excellent intermediate clinical performance

The Carpentier-Edwards supraannular porcine bioprosthesis, an investigational valve, was implanted in 1167 patients (1174 operations, 1274 valves) between November 1981 and December 1985 (age range 13 to 85 years, mean 61 years). The early mortality rate was 7.2% (with concomitant procedures 10.9%, without 4.8%; with previous operation 10.5%, without 6.6%). The late mortality rate was 4.5% per patient-year (aortic valve replacement, 4.0%; mitral valve replacement, 4.8%; multiple valve replacement, 5.6%). Total cumulative follow-up was 2272.3 years. The prevalence of thromboembolism was 2.6% per patient-year (fatal 0.4% per patient-year, major 1.4%, minor 1.2%); hemorrhage related to antithromboembolic therapy, 0.7% (fatal 0.1%); prosthetic valve endocarditis, 0.4% (fatal 0.2%); periprosthetic leak, 0.4% (fatal 0%); structural valve deterioration (primary tissue failure/structural failure), 0.1% per patient-year; and clinical valve dysfunction, 0.4%. The reoperation rate was 0.8% per patient-year (thromboembolism, 0.1%; clinical valve dysfunction, 0.1%; prosthetic valve endocarditis, 0.1%; periprosthetic leak, 0.4%; structural valve deterioration, 0.1%). Thromboembolism occurred throughout the observation period but with decreasing frequency, hemorrhage throughout the period in no predictable fashion, prosthetic valve endocarditis within 2 years, periprosthetic leak within 2 years, and structural valve deterioration occurred during the fourth year of assessment. The overall survival rate was 79.8% +/- 1.7% (4 years). Freedom (at 4 years) from thromboembolism was 92.2% +/- 1.2%; from structural valve deterioration, 98.8% +/- 0.8%; and from reoperation, 95.8% +/- 1.3%. Freedom from all complications (4 years) was 85.9% +/- 1.7%; from complication mortality, 98.4% +/- 0.4%; and from valve failure (mortality and reoperation), 94.3% +/- 1.3%. This investigational Carpentier-Edwards supraannular porcine bioprosthetic valve has provided excellent clinical performance and remains our overall prosthesis of choice.

Leukocytes, platelets, and surface microstructure of spontaneously degenerated porcine bioprosthetic valves.

The microstructure of 33 spontaneously degenerated porcine bioprosthetic valves was assessed by scanning electron microscopy in order to gather insight regarding the degenerative process. Twenty-four mitral and 9 aortic valves were removed from 32 patients. The duration of insertion was 7.7 +/- 2.4 years (mean +/- SD). All valves showed denudation of endothelial cells and exposure of the subendothelial fibrous tissue. Fibroblastlike cells were occasionally seen. Platelet deposits were observed on 22 of 33 valves (67%). Leukocytes were observed on the surface of 27 of 33 valves (82%). Mononuclear leukocytes were the most common category of cells (66%). Crystalline material was present on the surface of some leukocytes, suggesting that they may serve as a nidus for calcification. Transmission electron microscopy showed leukocytes in the process of phagocytizing collagen fibers. Macrophages, by exerting their scavenger function seem to contribute to destruction of the collagen framework of the valves. Whether the observed lymphocytes and plasma cells reflect an immunological involvement is unclear.

Q Fever Endocarditis on Porcine Bioprosthetic Valves

Three patients developed Q fever endocarditis on porcine bioprosthetic valves. They had a subacute or chronic course with nonspecific symptoms, enlargement of the liver and spleen, and cardiac failure due to destruction of the cusps, without disruption of the valve ring. High-phase I-specific IgG and IgA antibody titers against Coxiella burnetii were found. C. burnetii was isolated in each patient by inoculating suspensions of valve tissue into a human fetal diploid fibroblast cell line, which was grown as monolayers on slides contained inside rubber-stoppered tube cultures. Patients were treated successfully with doxycycline, cotrimoxazole, and valve replacement and were followed up for periods of 24 to 42 months; no evidence of deterioration was found. The human fetal diploid cell culture may be an expeditious, easy, and safe method to isolate C. burnetii from cardiac valves. Valve replacement seemed necessary to cure prosthetic-valve endocarditis due to C. burnetii infection. Combined therapy with doxycycline and cotrimoxazole may control the disease and prevent reinfection of the homografts replacing the valves.

Incidence of Primary Tissue Valve Failure in Porcine Bioprosthetic Heart Valves

This report provides retrospective follow-up data on 324 consecutive patients who received a Hancock-I porcine valve in the aortic or the mitral position, or in both positions, between June, 1974, and December, 1976. This analysis included 319 valves (193 mitral, 126 aortic) available for study of the incidence of primary tissue valve failure after 10 to 12.5 years of follow-up. Of the 319 prostheses at risk, 114 instances of primary tissue valve failure occurred. Seventy-three of the failed valves were in the mitral position, and 41 were in the aortic position. The calculated actuarial probability of freedom from primary tissue valve failure was 52 ± 5% for the mitral and 58 ± 6% for the aortic prostheses at 12.5 years of follow-up. For patients older than 40 years at the time of operation, the rate of freedom from primary failure was 68 ± 8% and 55 ± 6% for aortic and mitral prostheses, respectively, at 12.5 years. Comparison of both actuarial curves disclosed no meaningful difference. However, a tendency toward greater failure rate was observed in the mitral prosthesis group.

Long-term performance of porcine heart valve bioprostheses

To assess the results after long-term implantation of porcine bioprosthetic heart valves, 320 patients with 381 valves were retrospectively reviewed. This group included all patients receiving one such xenograft in the mitral or aortic position (or both) in our institution between June 1974 and December 1976. The patients had a follow-up of 9-11.5 years. Actuarial patient survival rats (hospital mortality excluded) were 85%-90% at 6 years and 68%-79% at 11.5 years. Thromboembolic episodes did not show any significant clustering over the first weeks or months, in fact, they appeared at a constant rate. Actuarial rates of freedom from thromboembolism were greater than 90% for aortic patients at 11.5 years and greater than 80% for mitral and mitroaortic patients at 11.5 years. The linearized rate of anticoagulant-related haemorrhage for the whole group of patients was 0.4 events/100 patient years with a related mortality of 0.2 events/100 patient years. Prosthetic valve endocarditis and paravalvular leak appeared at linearized rates of 0.6 (0.1 of related mortality) and 0.4 (0.1 of related mortality) events/100 patient years. Primary tissue valve failure constituted the most prevalent complication (82 cases) in the long term but did not significantly worsen patient survival. Actuarial rates of freedom from primary tissue failure were 91% +/- 2% at 6, and 40% +/- 14% at 11.5 years for mitral valves, and 95% +/- 4% at 6 and 64% +/- 6% at 11.5 years for aortic valves.(ABSTRACT TRUNCATED AT 250 WORDS)

Effects of focal thickening on leaflet stresses in a closed bioprosthetic valve: Computations based upon a 3-D linear model

A 3-D stress analysis of a porcine bioprosthetic valve leaflet was carried out using the finite element method. Irregularities of leaflet thickness, which can occur with degeneration of such valves, were modeled by introducing increased thickening at a selected site. The tissue was assumed to be isotropic with a Poisson's ratio of 0.3 and a Young's modulus of 5000 kPa. The geometry of the leaflet was approximated as one-half of an elliptic-paraboloid. The stresses were first determined in a normal leaflet with a constant thickness of 0.6 mm and then in a leaflet with a focal thickening of 1.2 mm. The maximal principal stresses predicted for a normal leaflet, 480 kPa, and the focally thickened leaflet, 520 kPa, were of the same order of magnitude and occurred at the aortic surface. Stresses across the thickness were nearly constant and tensile in nature for the uniformly thick leaflet. However, focal thickening markedly altered the stress distribution across the thickness. In the region of focal thickening, compressive stresses occurred at the ventricular surface and tensile stresses developed at the aortic surface. This resulted in a flexure-type deformation. Such a change in the distribution of stress across the leaflet thickness may contribute to further structural deterioration.

Utility of Physical Examination and Noninvasive Tests in the Diagnosis of Degeneration of Porcine Bioprosthetic Valves in the Mitral Position

Utility of Physical Examination and Noninvasive Tests in the Diagnosis of Degeneration of Porcine Bioprosthetic Valves in the Mitral Position

Vibrational analysis of bioprosthetic heart valve leaflets using numerical models: effects of leaflet stiffening, calcification, and perforation.

The fundamental natural frequency of the closed cusps of porcine bioprosthetic valves, fabricated from the normal leaflets of pig aortic valves, was estimated using a finite element model. Both normal and stiffened leaflets were considered in the vibrational analysis. The effects of conditions that simulated degeneration, such as stiffening, central perforation, a tear, calcium deposits in the commissural attachments, and combinations of these were determined. The primary frequency of vibration of the normal leaflets was within the range of the dominant frequency of the heart sounds determined clinically by spectral analysis of the recorded phonocardiogram. If only one leaflet was stiffened or calcified, there was only a marginal change of frequency. With stiffening and calcification of the commissures of all 3 leaflets, the frequency of vibration increased. Introduction of a tear in a single leaflet of a stiffened and calcified valve markedly reduced the fundamental frequency. In view of the relation between the frequency content of heart sounds and the frequency of valve vibration, this mathematical simulation establishes a possible basis for the observation of a varying dominant frequency of heart sounds in patients with bioprosthetic valves that are in the process of degenerating.

Balloon dilatation of porcine bioprosthetic valves in the pulmonary position.

Balloon dilatation (BD) of bioprosthetic valves was investigated in vivo and in vitro. Four children with stenotic bioprosthetic porcine valves in the pulmonary position underwent BD of the valve 10 to 24 months after its insertion. Average valve gradient was reduced from 47.5 to 27 mm Hg. Obstruction at the conduit-branch pulmonary artery connection became apparent after dilatation of the valve. These distal stenoses were also dilated. BD technique was tested in vitro with the use of nonstenotic valves in fresh conduits. No damage to the valve or to the conduit was found when oversized balloons were used in a standard fashion or intentionally inflated until rupture. It is concluded that conduit replacement may be deferred by balloon dilatation of obstructed biological valves and/or a stenotic conduit-pulmonary artery anastomosis.

Accurate Patient Diagnosis of Acute Porcine Valve Failure

Spontaneous porcine bioprosthetic valve failure is usually of gradual onset. We report a case of acute porcine mitral valve rupture resulting in rapid hemodynamic decompensation. The patient perceived the moment of valvular failure as the abrupt onset of a vibrating sensation in his chest. As the number of patients with porcine bioprostheses continues to increase, acute valvular failure may become a more common clinical entity.

Evaluation of the influence of leaflet stiffening on leaflet stresses of porcine bioprosthetic valves using a finite element model

The magnitude and distribution of mechanical stresses acting on the closed cusps of porcine bioprosthetic valves were estimated using a finite element model. Leaflet stresses were calculated using reported stress-strain properties of glutaraldehyde processed normal porcine valves and stress-strain properties of porcine valve leaflets stiffened by fatigue cycling (658 x 10 cycles). In the normal leaflet, at a pressure of 80 mm Hg, stresses were highest near the commissures (140 kPa), decreased near the center of the leaflet (110 kPa) and were lowest near the base of the leaflet (30 kPa). With increased leaflet stiffening, stresses near the commissures remained relatively unchanged (140 kPa). Stresses near the center of the leaflet, however, increased markedly (170 kPa). With increased leaflet stiffening, stresses near the base of the leaflet remained the lowest (60 kPa). The development of a site of stress concentration near the center of the leaflet following leaflet stiffening, may offer a clue to the etiology of leaflet perforations reported to occur in the central region of leaflets of degenerated porcine bioprosthetic valves.

Blunt Rupture of Both Atrioventricular Valves

Younger patients are surviving extensive damage to the heart and supporting structures, often associated with multiple systems injuries. A 23-year-old patient who sustained blunt trauma to the chest resulting in a pericardial laceration, injury to tricuspid and mitral valves, myocardial contusion, and paresis of the left phrenic nerve is reported. Porcine bioprosthetic valve replacement of both atrioventricular valves was necessary. Prompt diagnosis and aggressive intervention of such injuries can lead to successful repair of complex cardiac trauma.

Percutaneous balloon valvuloplasty for stenosis of a porcine bioprosthesis in the tricuspid valve position

Recently, percutaneous balloon dilatation has been successfully used for treatment of congenital aortic and pulmonary valvular stenoses. 1 We report the first case of percutaneous valvuloplasty of a severely stenosed porcine bioprosthetic valve.

Mechanical Stresses on Closed Cusps of Porcine Bioprosthetic Valves: Correlation with Sites of Calcification

The purpose of this study was to (1) evaluate the magnitude and distribution of mechanical stresses on closed leaflets of porcine bioprosthetic valves (PBVs) by using a nonlinear, finite-element model, and (2) determine if a relationship exists between the magnitude of stresses at various sites on the leaflet and the incidence of calcification at those sites. Mechanical stresses were found to be highest near the commissures and lowest at the base of the leaflet. At a pressure of 100 mm Hg applied to the closed valve, the maximal principal normal stress was 160 kPa near the commissures, 140 kPa in the body of the leaflet, 70 kPa at the free margin, and 60 kPa near the base. Similarly, the maximal shear stress, at an applied pressure of 100 mm Hg, was 80 kPa near the commissures, 70 kPa in the body of the leaflet, 50 kPa at the free margin, and 40 kPa near the base. This distribution of mechanical stresses on the PBV leaflet coincided with the incidence of calcification of the various regions of the leaflet. Calcification was found most frequently near the commissures, less frequently in the body of the leaflet and free margin, and least frequently at the base. These observations suggest a possible causative relation between the magnitude of mechanical stresses and the site of calcification of PBV leaflets.

An eight-year experience with porcine bioprosthetic cardiac valves

A total of 589 porcine bioprostheses were implanted in 509 patients from January, 1976, through December, 1983. Of the valves implanted, 390 were Hancock and 199 were Carpentier-Edwards. A total of 1,633 patient-years was accrued, with a mean follow-up of 38 months per patient. Two hundred eight patients had aortic valve replacement, 209 had mitral valve replacement, and 79 had multiple valve replacements, of which 46 were aortic and mitral replacements. The mortality for isolated aortic valve replacement was 5.8%; for isolated mitral replacement, 8.6%, and for all patients, 10.9%. Late mortality was 3.9% per patient-year. The actuarial survival rate at 5 years was 79% for aortic, 68% for mitral, and 76% for aortic-mitral valve replacement. There were 12 thromboembolic events (0.73% per patient-year). Two episodes occurred in patients with an aortic bioprosthesis, nine in patients with a porcine mitral valve, and one in a patient with mitral and tricuspid bioprosthetic valves. The probability of remaining free of thromboembolism at 5 years was 99% for the group having aortic valve replacement, 93% for those having mitral replacement, and 100% for the group having aortic-mitral valve replacements. Thirteen episodes of endocarditis occurred (0.8% per patient-year). Seven of the 13 patients died as a direct result of endocarditis. The probability of remaining free of prosthetic endocarditis at 5 years was 97% for the aortic valve replacement group, 95% for the mitral group, and 97% for the aortic-mitral group. There were 20 instances of xenograft failure (1.2% per patient-year). The probability of remaining free of valve failure at 5 years was 96% for the aortic valve replacement group, 93% for the mitral group, and 93% for the aortic-mitral replacement group. Primary tissue failure of a prosthesis occurred in seven patients, all with Hancock valves (0.43% per patient-year). As yet there has been no primary tissue failure of the Carpentier-Edwards prosthesis. There also appears to be a lower incidence of thromboembolism (Edwards, 0.3% per patient-year; Hancock, 0.8% per patient-year) and endocarditis (Edwards, 0.6% per patient-year; Hancock, 1.0% per patient-year). The low incidence of complications with the porcine bioprosthetic valve, especially the Carpentier-Edwards, encourages us to recommend its continued use, especially in situations in which anticoagulation is contraindicated.

Experience with the Selective Use of the Carpentier-Edwards Bioprosthesis

Between April, 1977, and November 1984, 136 porcine bioprosthetic valves were implanted in 122 patients principally selected on the basis of age and contraindication to anticoagulants. The following procedures were carried out: aortic valve replacement (AVR) 88, pulmonary valve replacement (PVR) 1, mitral valve replacement (MVR) 38, and tricuspid valve replacement (TVR) 9. The ages ranged from 25 to 84 years (mean 64.6 years). The 30-day mortality was 11.5% overall. Survivors were followed up to 7 years (mean 29.2 months). Actuarial survival rates at 5 years, including operative deaths, were as follows: AVR 76.2 +/- 9.3%, MVR 59.7 +/- 12.6% and combined valve replacement (CVR) 47.1 +/- 19.4%. The 5-year probability of freedom from valve-related complications was 76.8 +/- 6.9% for all patients. The rate of thromboembolic events was 3.80% per patient-year after AVR and 2.72% per patient-year after MVR and CVR. The embolic rate did not differ between patients treated with anticoagulants and those treated with platelet antiaggregators. Primary tissue valve failure occurred in 2 patients for a linear incidence of 0.77% per patient-year. Postoperative echocardiography was performed in 83% of the survivors. Patients are now prospectively followed up by bidimensional echography and pulsed Doppler in order to detect early valvular dysfunction. The performance of the Carpentier-Edwards porcine bioprosthesis is, thus, satisfactory in this group of elderly patients.

Fate of Left-Sided Cardiac Bioprosthesis Valves in Children

To avoid anticoagulation and minimize thromboembolic phenomena, between 1975 and 1980 we used 18 porcine bioprosthetic valves (BPVs) to replace 11 aortic and seven mitral valves in 17 children ranging from 7 to 18 years of age (mean, 8.2 years). Ten BPVs (91%) in the aortic position had to be replaced one to six years (mean, 4.2 years) after insertion. Nine of these valves developed severe calcification with leaflet immobility and severe stenosis. The tenth valve became insufficient with a disrupted cusp. Six (86%) of seven BPVs inserted in the mitral position required replacement two to four years (mean, 3.1 years) after insertion. Massive mitral regurgitation developed in three, while in the other three mitral stenosis was prominent. All explanted BPVs exhibited calcification with disruption and loss of mobility of the leaflets. Hemodynamic deterioration often occurred catastrophically, with nine patients requiring emergency valve replacement. Elective valve replacement carried no hospital mortality, whereas emergency valve replacement carried a 33% mortality. The BPV failure rate of 94% within six years leads us to recommend against the use of biologic valves in the pediatric age group in the aortic or mitral position. Bioprosthetic valve failure may occur catastrophically and replacement should be carried out early to avoid the higher operative mortality associated with emergency surgery.

Hemodynamic differentiation of pathologic and physiologic stenosis in mitral porcine bioprostheses

Porcine bioprostheses are physiologically stenotic valves. Degenerative calcification leading to pathologic stenosis is an increasingly recognized serious late complication of mitral valve replacement with a porcine bioprosthesis. Hemodynamic differentiation of pathologic from physiologic stenosis is important for identification of porcine bioprosthetic valve dysfunction. In 42 patients with a normal Hancock porcine bioprosthesis (standard model, sizes 27 to 33 mm), mean diastolic flow (65 to 461 ml/s), mean gradient (2.0 to 13.4 mm Hg) and effective orifice area (1.1 to 4.4 cm2) were determined at rest, during epicardial pacing (90, 110 and 130/min) and with isoproterenol infusion. A statistically significant increase in mean gradient occurred with increases in flow and decreases in valve size (p less than 0.05). Effective orifice area increased significantly as flow rate increased and as valve size increased (p less than 0.05). These measurements were compared with those in 16 patients with pathologically confirmed porcine bioprosthetic valve stenosis: 8 patients with reoperation (1.1% per patient-year) 3 to 8.5 years after mitral valve replacement and 8 previously reported abnormal cases. Stenotic failure rate was inversely related to valve size (2.1, 1.4, 0.5 and 0% per patient-year for sizes 27 to 33 mm). Stenotic and normal bioprostheses were not accurately differentiated on the basis of a single value for gradient or effective orifice area. A mathematical model that related flow to the square root of the mean gradient allowed complete separation of stenotic from normal prosthetic valve function, after valve size was accounted for and normal confidence limits were established (r = 0.74 to 0.94, sizes 27 to 33, p less than 0.0001). The effective orifice area-flow relation did not provide accurate differentiation of abnormal from normal function. Thus, normal mitral bioprostheses have significant transvalvular gradients whose magnitude depends on flow. Risk of stenotic failure is increased in the smaller valves, which have a larger gradient at implantation. Differentiation of pathologic from physiologic stenosis cannot be made on the basis of a single value for gradient or effective orifice area. Accurate hemodynamic differentiation is achieved by relating mean gradient to mean diastolic flow rate and valve size.

Primary failure of Hancock porcine bioprosthetic valves: two dimensional echocardiographic assessment.

To reveal the process of primary failure of the Hancock porcine bioprosthetic heart valve, a real-time two-dimensional echocardiography was undertaken. There were 75 cases (84 valves) with 26 in the aortic valve position, 39 in the mitral valve position, 9 in both the aortic and mitral valve positions, and 1 in the tricuspid valve position. The subjects comprised 35 males and 40 females, whose ages ranged from 18 to 65 years with a mean of 44.7 years. Valvular changes such as thickened valve cusps or abnormal valve movement were observed in 27 (32%) of the 84 valves; more specifically, in 5 (14.3%) of the 35 aortic valves and in 22 (45.8%) of the 48 mitral valves, indicating that valvular changes occurred most frequently in the mitral valve position (p less than 0.01). In the period between valve replacement surgery and the appearance of valvular changes, no significant difference was noted between aortic and mitral valve bioprostheses. The duration ranged from 14.5 to 74.5 months with a mean of 50.2 months. Valvular changes were evident in more than 50% of the valve bioprostheses implanted 6 or more years ago. In the mitral valve position, valve cusp changes appeared more frequently at the anterior cusp than at the inner and outer cusps. The frequency was 17 cases at the anterior cusp, 6 at the inner and 9 at the outer. In 7 of the 11 cases followed up after the appearance of valvular changes, an increase in the changes was recognized 7.5 to 29.5 months (a mean of 16.4 months) later.(ABSTRACT TRUNCATED AT 250 WORDS)