Severe stenosis of bioprosthetic valve due to late valve thrombosis

The typical cause of bioprosthetic valve dysfunction over years is calcification of leaflets, pannus formation, or tears due to structural degeneration. Thrombosis is rare as the valves get endothelialized early on, and, hence, anticoagulation is not recommended beyond 6 months after valve replacement. While bioprosthetic valve thrombosis is unusual (0.03% to 0.34%/year), it can be associated with significant mortality and morbidity. Here, we present a case of a middle-aged man with history of bioprosthetic mitral valve who presented with syncopal episode and was referred to us for mitral valve replacement for tentative bioprosthetic valve degeneration and stenosis. However, preoperative work up revealed prosthetic valve thrombosis which was successfully treated with anticoagulation.     

A case of bioprosthetic mitral valvular dysfunction due to pannus-formation

A case of bioprosthetic mitral valvular dysfunction accompanied by mitral stenosis due to pannus is reported. A 69-year-old woman, whose mitral valve had been replaced with a Hancock bioprosthetic valve in June 1979, underwent the second mitral valve replacement in September 1988 because of valvular dysfunction. The ring and cusps of this Hancock valve was partially covered with hard and milky white pannus which resulted in mitral stenosis. The tear of cusp was observed at the point of contact with pannus, which resulted in mitral regurgitation. Histologically, pannus was consisted of two-layered structure, fibrin and collagen fiber, which demonstrated this over-growth was based on thrombus. Main causes of bioprosthetic valve dysfunction are calcification and tear of cusps. But, valvular dysfunction due to pannus-formation described in this case has been experienced very rarely.     

Long-term results of porcine bioprosthetic heterograft; a 13-years' experience

One hundred and ninety-four patients underwent valve replacements with the glutaraldehyde-preserved porcine bioprostheses (133 Hancock valves, 39 Angell-Shiley valves, 22 Carpentier-Edwards valves and 3 other valves) from 1974 through 1979. There were 105 women and 89 men, whose age ranged 18 to 62 (mean 38.8) years. One hundred and eighty-two patients had mitral bioprosthetic valve replacement (BVR)s, of which 52 had combined aortic mechanical valve replacements, 8 had aortic BVR's, 3 had tricuspid BVR's and 3 had multi-BVR's. Operative mortality was 10.8%. Only one patient was lost to follow-up. Cumulative duration of follow-up is 1421 patient-years. Linearized rate of anticoagulant related hemorrhage, thromboembolism (TE), prosthetic valve endocarditis (PVE), primary tissue failure (PTF) and valve dysfunction (VD) were 0.07, 1.62, 0.49, 2.74 and 3.66% per patient-year. Actuarial freedom from TE, PVE, PTF and VD were 87.0 +/- 2.7%, 95.6 +/- 1.5%, 65.2 +/- 4.9% and 56.9 +/- 5.6% at 13 years. Actuarial survival rate was 67.4 +/- 4.0% at 13 years. Long term follow-up after valve replacement with porcine bioprosthetic valve confirms low thrombogenicity. But primary tissue failure was the chief cause of valve dysfunction and represent a major problem. At this time, we are going to use porcine bioprosthetic valve in the selected patients, that is in the situations in which anticoagulation is contraindicated.     

Surgical management of valve replacement in children

From 1965 to 1990, 49 valve replacements were performed on 43 patients under the age of 15. Mitral valve replacements were performed on 21 patients, and re-replacements were done on 4 of them afterwards. In the first 9 mitral valve replacements before 1974, Starr-Edwards (S-E) ball valves were used. Five of these patients died in the hospital (early mortality rate was 56%). Since 1975, bioprosthetic valves were used in three cases, but all of these valves ceased to function due to primary tissue failure (PTF) within 3 years. Consequently, SJM valves are now used as a first choice. Ten aortic valve replacements were performed on 9 patients with the results of one early death, two late deaths, and one late re-operation. Tricuspid valve replacements were performed on 11 patients, 5 of whom utilized S-E ball valves. Three of the five patients died in the hospital. One patient was re-operated on, swapping the S-E ball valve for the SJM valve. SJM valves were used primarily in 2 patients, and bioprosthetic valves in 4. Two patients died, one with a SJM valve, and the other with a bioprosthetic valve. Two pulmonary valve replacements were performed, one employing a SJM valve, the other a bioprosthetic valve. Two adult patients with SJM valve in the right side of the heart had thrombotic complications, though the patients with bioprosthetic valves had none. Atrioventricular valve replacements were performed on 5 patients under the age of 3, but all of them died.(ABSTRACT TRUNCATED AT 250 WORDS)     

The porcine bioprosthetic valve. Twelve years later

The porcine bioprosthetic heart valve has been commercially available since 1970 and has been the prosthetic heart valve of choice in our institution since 1971. Since that time 817 patients with 951 porcine valves have been discharged from the hospital and were available for long-term follow-up. Patient survival rates, with operative mortality excluded, were 80% +/- 1.7% (standard error) at 5 years and 68% +/- 2.7% at 10 years. Survival rates for patients with aortic valve prostheses were 78% +/- 2.8% at 5 years and 57% +/- 5.4% at 10 years; for patients with mitral valve prostheses, survival rates were 80% +/- 2.2% at 5 years and 69% +/- 3.2% at 10 years. Freedom from thromboembolism for aortic valves was 93% +/- 1.4% at 5 years and 88% +/- 2.6% at 10 years; for mitral valves the freedom from degeneration or primary tissue failure for aortic valves was 97% +/- 1.3% at 5 years and 71% +/- 7.6% at 10 years; for mitral valves these figures were 96% +/- 1.2% at 5 years and 71% +/- 4.1% at 10 years. Valves in patients 35 years of age and below had a significantly greater rate of degeneration (p less than 0.001). After 12 years' experience the porcine bioprosthetic valve has performed well with regard to patient survival and low rate of thromboembolism. For patients older than 35 years the freedom from primary tissue failure is 80% at 10 years.     

In Vitro Function and Durability Assessment of a Novel Polyurethane Heart Valve Prosthesis

Abstract While flexible-leaflet, central-flow prosthetic heart valves promise relief from anticoagulation therapy, they continue to be restricted by inadequate durability. In consequence, a novel trileaflet valve, made entirely from polyurethane, has been developed. A batch of 6 consecutively manufactured polyurethane valves was subjected to hydrodynamic function and accelerated fatigue testing. Computerized data acquisition and control systems have been introduced to improve valve testing methodologies. In terms of hydrodynamic function, the polyurethane valve demonstrates transvalvular pressure gradients similar to those for a bioprosthetic valve (Carpentier-Edwards) and levels of retrograde flow significantly less than those for either the bioprosthetic valve or a bileaflet mechanical valve (St Jude Medical). The equivalent of 10 years of cycling without failure has been exceeded by all 6 polyurethane valves in accelerated fatigue tests with 2 valves remaining intact after 674 million cycles (equivalent to approximately 17 years) in continuing tests. Highspeed photography revealed considerable differences in leaflet motion between valves cycled at accelerated and physiological rates.     

Selection of prosthetic heart valves for adult patients by age

The use of bioprosthetic heart valves has dramatically increased over the last decade. In 2004, the ratio was 52% for mechanical and 48% for bioprosthetic valves in a survey by the Japanese Association for Thoracic Surgery. This increase in the use of bioprosthetic valves is related to evidence demonstrating the durability of such valves over the last 20 years. The guidelines of the Japanese Circulation Society recommend selection of prosthetic heart valves by considering the patient's age. In patients who received a mechanical valve in previous cardiac surgery, selection of another mechanical valve is inevitable. The age of 65 years is when patients are separated into groups receiving either mechanical (<64 years) or bioprosthetic (> or =65 years) valves. However, the evidence that a bioprosthetic valve is better for patients in their 60s is somewhat questionable, particularly in Japanese with a long life expectancy. Anticoagulation with warfarin in patients with mechanical valves leads to a higher incidence of hemorrhagic complications compared with bioprosthetic valves, although the incidence of thromboembolism is the same. Thus patients with contraindications to warfarin or a low risk of thromboembolism who are more than 65 years old are reasonable candidates for a bioprosthetic valve. It is also recommended that women of childbearing age receive bioprosthetic valves after being informed of the possibility and risks of reoperation. In addition to the information in the guidelines and physicians' preference for valve selection, factors such as the patient's lifestyle, wishes, cardiac function, other complications, and longevity must always be considered when selecting a valve prosthesis.     

Cardiac valve replacement in patients on dialysis: influence of prosthesis on survival

BACKGROUND: Mechanical valves have been recommended for patients on dialysis because of purported accelerated bioprosthesis degeneration. This study was undertaken to determine time-related outcomes in dialysis patients requiring cardiac valve replacement. METHODS: From 1986 to 1998, 42 patients on chronic preoperative dialysis underwent valve replacement; 17 received mechanical valves and 25 received bioprostheses. Age was similar in both groups: 54+/-18.5 years (mechanical) and 59+/-15.5 years (bioprosthetic, p = 0.4). Sites of valve replacement were aortic (27), mitral (11), and aortic and mitral (4). Follow-up was 100% complete. RESULTS: Survival at 3 and 5 years was 50% and 33% after mechanical valve replacement, and 36% and 27% after bioprosthetic valve replacement (p = 0.3). Four patients with bioprostheses required reoperation: 3 for allograft endocarditis and 1 at 10 months for mitral bioprosthesis degeneration. One patient who received a mechanical valve required reoperation. CONCLUSIONS: Prosthetic valve-related complications in patients on dialysis were similar for both mechanical and bioprosthetic valves. Because of the limited life expectancy of patients on dialysis, bioprosthesis degeneration will be uncommon. Therefore, surgeons should not hesitate to implant bioprosthetic valves in these patients.     

Porcine bioprosthetic valve calcification in bovine left ventricle-aorta shunts: studies of the deposition of vitamin K-dependent proteins

Calcification of glutaraldehyde-preserved bioprosthetic cardiac valves represents a serious clinical problem. Previous work from this laboratory has established the presence in clinical bioprosthetic valve calcifications of vitamin K-dependent calcium-binding proteins, which contain the calcium-binding amino acid gamma-carboxyglutamic acid; no proteins containing gamma-carboxyglutamic acid are present in nonmineralized valves. The purpose of the present study was to examine a series of bovine circulatory bioprosthetic valve explants for calcification and proteins containing gamma-carboxyglutamic acid. Biochemical analyses of explanted bioprosthetic valves from calves demonstrated proteins with gamma-carboxyglutamic acid accumulating in calcified valves during both the onset and progression of valve calcification; calcium levels in the explanted calf bioprostheses were in the same range as those noted in clinical material. Accumulation of calcium and protein with gamma-carboxyglutamic acid occurred simultaneously and progressively, beginning 2 months after implantation. Small amounts of osteocalcin, the bone-derived protein containing gamma-carboxyglutamic acid, were present in both human and bovine bioprosthetic valve calcifications at comparable levels. No osteocalcin was detectable in non-mineralized valve tissue. Warfarin anticoagulant therapy did not prevent calcification or accumulation of protein with gamma-carboxyglutamic acid. It is concluded that proteins containing gamma-carboxyglutamic acid are involved in both the onset and progression of bioprosthetic valve calcification, and that conventional means of vitamin K antagonism do not alter this association or the course of bioprosthetic valve mineralization.     

Valve replacement in the right side of the heart in children: long-term follow-up

Twenty-five patients (16 male, 9 female) underwent right-sided valve replacement (10 pulmonary valve replacement, 14 tricuspid valve replacement, 3 tricuspid plus pulmonary valve replacement, and 2 replacements of a single atrioventricular valve) at the University of Nebraska Medical Center from June 1977 to December 1986. Twenty-one patients (84%) are long-term survivors with 2,035 months follow-up (range, 41 to 143 months; mean, 96.9 months). Twenty-three Carpentier-Edwards bioprosthetic valves, one Ionescu-Shiley bioprosthetic valve, and nine St. Jude Medical valves were inserted. Follow-up of 17 patients with a Carpentier-Edwards valve ranged from 5 years 9 months to 11 years 9 months (mean, 8 years 11 months). To date there has been one reoperation after 3 years 4 months in this group. One patient who received an Ionescu-Shiley bioprosthesis required re-replacement at 20 months after operation. Three of 4 patients who received St. Jude mechanical valves and are long-term survivors have required replacement after 36 to 56 months. We conclude that the Carpentier-Edwards bioprosthetic valve is a viable option in the right side of the heart in the young age group when annular size is adequate to accommodate an appropriate bioprosthesis.     

Binding of preformed xenoantibodies to porcine bioprosthetic valves

We have investigated whether preformed antibodies against xenoantigens bind to cellular elements remaining on porcine bioprosthetic valves after various methods of preservation. Fresh porcine valves treated with either acetone, 4% formaldehyde, or 0.625% glutaraldehyde, as well as an unfixed valve, were incubated with antiserum against porcine xenoantigens. This serum was prepared using the affinity purification method with porcine lymphocytes as the target. The valves were stained with secondary fluorescein-conjugated antibody against immunoglobulin M or immunoglobulin G and examined under fluorescent microscopy. Intense binding of immunoglobulin M to the endocardium was observed in the unfixed valve as well as in valves fixed in acetone and formaldehyde. Glutaraldehyde fixation eliminated binding of antibody. Binding was not noted within the connective tissue. No binding of antiimmunoglobulin G was noted on the endocardium of any of the sections. Examination of three glutaraldehyde-treated porcine valves explanted from the aortic position after 10 years in situ showed no immunoglobulin deposition. These results demonstrate the elimination of antigenicity to preformed antibodies in the endocardium and connective tissue of glutaraldehyde-preserved porcine valves. The findings may, in part, explain the poor performance of formaldehyde-preserved bioprosthetic xenograft valves in the past and support the use of glutaraldehyde as a preferred agent for preservation of bioprosthetic endovascular materials.     

Long-term follow-up of cardiac valve replacement using bioprosthesis in patients 70 years old and older

Good long-term results with the bioprosthetic valves for patients 70 years old and older have been reported. However, because the average lifespan is increasing, we aimed to clarify whether patients older than 70 may still be candidates for valve re-replacement. Seventy-one patients 70 years old and older, who received a total of 81 bioprosthetic valve replacements during 73 procedures between 1988 and 2000, were reviewed. There were 8 hospital and 7 late deaths. Ten-year actual survival after valve replacement was 73.5%, and 82.8% when hospital deaths were excluded. During the follow-up period, 2 patients received mitral valve re-replacement. Ten years of freedom from reoperation were found in 66.7% for all valves and in 50.0% for mitral valves. The average lifespan in Japan is currently 77.64 years for men and 84.62 years for women; therefore, valve degeneration in patients who receive bioprosthesis replacement in their early 70s should be anticipated.     

Bioprosthetic heart valve rupture associated with trauma

Disruption of a bovine pericardial bioprosthetic aortic heart valve occurred in a motor vehicle accident, and was treated by valve replacement for progressive aortic insufficiency. Leaflet rupture was through areas of noninflammatory tissue degeneration, corresponding to regions of repeated mechanical stress and trauma that occur during the normal function of tissue valves. Patients with bioprosthetic heart valves may be predisposed to traumatic valve injury. Early diagnosis and replacement of these disrupted valves should be accomplished to avoid sudden, unpredictable heart failure.     

Comparative analysis of mechanical and bioprosthetic valves after aortic valve replacement

Comparative long-term performance characteristics of Bj?rk-Shiley mechanical and bioprosthetic valves were analyzed for patients undergoing aortic valve replacement between 1976 and 1981. A total of 419 patients received either a standard Bj?rk-Shiley (n = 266) or bioprosthetic (porcine, n = 126, or pericardial, n = 27) aortic valve. Cumulative patient follow-up was 1,705 patient-years; the average patient follow-up was 4.1 +/- 2.7 years. Survival data were obtained for all but 11 patients (97% complete follow-up) up to 9 years after operation. Survival at 5 years was 81% +/- 4% (+/- standard error) for Bj?rk-Shiley and for bioprosthetic valve recipients. Valve failure in the Bj?rk-Shiley group was predominantly due to valve-related mortality and did not result from structural failure. Patients with bioprosthetic valves experienced valve failure as a result of prosthetic valve endocarditis and intrinsic valve degeneration. Although patients with bioprostheses experienced a lower incidence of valve-related morbidity than Bj?rk-Shiley valve recipients (p less than 0.03), no difference could be demonstrated in the incidence of valve-related mortality or valve failure at 5 years between bioprosthetic and Bj?rk-Shiley valves. Mortality rate from valve failure was higher for Bj?rk-Shiley (86%, 12/14) than bioprosthetic valves (36%, 5/14) (p less than 0.01).     

Premeditated reoperation after mitral valve replacement with a Starr-Edwards ball valve for young women who desire to bear a child: Report of two cases

There are many difficulties for young women with a Starr-Edwards ball valve who want to attempt pregnancy. There is no consensus regarding whether they should maintain anticoagulation therapy throughout pregnancy with the risk of a thromboembolism or to undergo a reoperation with bioprosthetic heart valves, followed by a third operation when the valve deteriorates. This report presents two cases of young women who underwent mitral valve replacement (MVR) with Starr-Edwards ball valves (model 6120: 1M) during their childhood. Although they did not have any cardiac symptoms, transthoracic echocardiography and cardiac catheterization data demonstrated that both the patients had asymptomatic mild relative mitral stenosis. They both wished to bear a child. After the patients and their family provided thorough informed consent, redo MVRs were preformed safely with biological prostheses. The presence of significant pannus formation along the strut and sewing ring of the excised valves could also have a positive impact on the decision to undergo reoperation.     

Starr-Edwards valves at the aortic and mitral positions implanted for 39 years

Cloth-covered Starr-Edwards caged ball valves implanted in the aortic and mitral valve positions for 39 years were extracted. Both showed valve dysfunction resulting from pannus overgrowth. The metal cages of the Starr-Edwards valves were covered with worn cloth. This case indicates the extended durability of Starr-Edwards valves and the importance of the design and materials of prosthetic heart valves to avoid pannus overgrowth and prosthetic valve abrasion.     

Long-term results of bioprosthetic mitral valve replacement: the pericardial perspective

Pericardial valve bioprostheses were introduced in early 1970s and were widely used in the 1980s. The longterm results with the Ionescu-Shiley valve, the first commercially available pericardial valve, were disappointing because of high rate cusp tears during the first decade after implantation. The enthusiasm for this type of bioprosthetic valve was further hampered by the premature failure of the Hancock pericardial valve. The long-term results of aortic valve replacement with the Carpentier-Edwards pericardial valve, which was introduced in 1981, indicated that that valve was durable and the issue of cusp tears had been resolved by an appropriate design. This knowledge prompted surgeons to revisit the merits of pericardial valves for mitral valve replacement and several other pericardial valves are now commercially available. The largest data on long-term results are with the Carpentier-Edwards pericardial mitral valve. The reported freedom from structure valve failure ranged from 69% to 85% at 10 years in patient population with mean age of 60 to 70 years. Young age is a major determinant of valve failure, which is largely due to calcification. There are also long-term data, albeit more limited on the Sorin Pericarbon and Mitroflow valves used for mitral valve replacement. This paper review the published experience with various pericardial bioprosthetic valves used for mitral valve replacement during the past 3 decades.     

Fate of a second porcine bioprosthetic valve

Since October, 1971, 744 porcine bioprosthetic valves were inserted in patients discharged from the hospital and were therefore at risk for primary valve failure or tissue degeneration. In this period of time, 41 valves have demonstrated spontaneous degeneration. The percentages of valve survival without degeneration are as follows: at 6 yeras, 93% +/- 1.5% (SE); 7 years, 88% +/- 2.0%; 8 years, 82% +/- 2.9%; 9 years, 80% +/- 3.4%. The incidence of degeneration appears to be decreasing even though the total number of valves at risk is increasing each year. Of the 41 valves removed for spontaneous degeneration, 25 valves in 24 patients have been replaced by a second bioprosthesis. These 24 patients have been followed up for from 2 to 61 months, and there has been no clinical evidence of degeneration of the second bioprosthesis. One patient has had a second bioprosthesis longer than the first. Although others have suggested that degeneration may be immunologic event, our experience suggests that there is no "second set" rejection. The absence of a "second set" rejection and the suggestion of a decreasing incidence of degeneration makes us continue to favor the bioprosthesis for primary and secondary valve replacement.     

Tricuspid valve replacement with bioprostheses: long-term results and causes of valve dysfunction

BACKGROUND: Although the clinical performance of bioprostheses after valve replacement in the aortic and mitral position has been reported, little is known of the performance of tricuspid bioprostheses. The mechanism of bioprosthetic valve dysfunction after tricuspid valve replacement (TVR) is not clear. METHODS: We reviewed 98 cases of TVR with bioprostheses. To clarify the causes of valve dysfunction, pathologic examination of the explanted valve at the reoperation was performed. RESULTS: Actuarial survival at 18 years was 68.7% +/- 5.8%. There were 12 redo TVRs. In six of the 12 cases, isolated redo TVR was performed. In the other cases, concomitant cardiac procedures were performed. The causes of prosthetic valve dysfunction were pannus formation on the cusps of the right ventricle side (four cases), native valve attachment (two cases), pannus formation + native valve attachment (two cases), sclerotic change (one case), pannus formation + sclerotic change (one case), and native valve attachment + valve infection (one case). Freedom from reoperation, structural valve deterioration, and nonstructural dysfunction at 18 years was 62.7% +/- 10.7%, 96.0% +/- 2.9%, and 76.7% +/- 8.3%, respectively. CONCLUSIONS: In our 18 years of experience, although the survival after TVR with bioprostheses is acceptable, the reoperation free rate is not satisfactory. Pannus formation on the cusps of the ventricular side seems to be a serious problem that causes bioprosthetic dysfunction in the tricuspid position.     

Aortic valve selection in the elderly patient

To determine the influence of valve selection on valve-related morbidity and mortality and patient survival, comparative long-term performance characteristics of mechanical (N = 68) and bioprosthetic (N = 73) heart valves were analyzed for 141 patients more than 70 years old who underwent isolated aortic valve replacement between 1970 and 1985. Cumulative patient follow-up was 491 patient-years (average, 4.3 years per patient). Hospital mortality was 18% and 19% for patients with mechanical valves and bioprosthetic valves, respectively. Survival at 5 years was 61 +/- 7% (+/- the standard error) and 67 +/- 10% for recipients of mechanical valves and bioprosthetic valves, respectively. Male sex (p = 0.014) and urgency of operation (p = 0.006) were independent risk factors for hospital mortality. Atrial fibrillation increased valve-related mortality (p = 0.01). No patient required reoperation or experienced structural valve failure. While anticoagulant-related hemorrhage was increased in recipients of mechanical valves (9.2 +/- 2.1%/patient-year) compared with recipients of bioprosthetic valves (2.3 +/- 1.1%/patient-year), it did not result in a death or lead to permanent disability. There was no difference in freedom from any valve-related complication at 5 years. However, when all morbid events are considered, recipients of bioprosthetic valves experienced fewer valve-related complications than patients receiving mechanical valves (10.7 +/- 2.3%/patient-year versus 17.6 +/- 2.5%/patient-year, respectively; p less than 0.05). The reduced incidence of anticoagulant-related hemorrhage and the infrequent need for warfarin sodium anticoagulation favor selection of a bioprosthetic heart valve in patients older than 70 years.