On Stress Reduction in Bioprosthetic Heart Valve Leaflets by the Use of a Flexible Stent

It has been postulated that flexible stent posts can reduce tensile stress at the commissures of tissue heart valves by about 90% when compared with the same valve mounted on a rigid stent. We have used a detailed computer model to investigate the role of flexible stent posts in reducing stress in the leaflets of three types of bioprosthetic heart valves: the bovine pericardial and the high- and zero-pressure fixed porcine valves. The models use stress/strain data from biaxial experiments to characterize the tissue properties and are subjected to a back pressure of 120 mmHg. We found that strain was reduced linearly with stent post deflection and that this was a purely static process--it did not require the load to be applied impulsively. This finding was in close agreement with earlier experimental studies, which measured the same strain reduction whether the valve was loaded quasi-statically or at physiological rates. In addition, we found that for this mechanism to be effective the valve must have good coaptation at the center and the tissue should be stiff; in other cases, the advantages of strain reduction through the use of a flexible stent are considerably diminished.     

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)     

Ventricular assist device in patients with prosthetic heart valves

Ventricular assist device (VAD) support inpatients with a prosthetic heart valve had previously been considered a relative contraindication due to an increased risk of thromboembolic complications. We report our clinical experience of VAD implantation in patients with prosthetic heart valves, including both mechanical and bioprosthetic valves. The clinical records of 133 consecutive patients who underwent VAD implantation at a single institution from January 2002 through June 2009 were retrospectively reviewed. Six of these patients had a prosthetic valve in place at the time of device implantation. Patient demographics,operative characteristics, and postoperative complications were reviewed.Of the six patients,four were male.The mean age was 57.8 years (range 35–66 years). The various prosthetic cardiac valves included a mechanical aortic valve (n = 2), a bioprosthetic aortic valve (n = 3), and a mechanical mitral valve (n = 1).The indications for VAD support included bridge to transplantation (n = 2), bridge to recovery (n = 1), and postcardiotomy ventricular failure(n = 3). Three patients underwent left ventricular assist device placement and three received a right ventricular assist device. Postoperatively, standard anticoagulation management began with a heparin infusion (if possible)followed by oral anticoagulation.The 30-day mortality was50% (3/6). The mean duration of support among survivors was 194.3 days (range 7–369 days) compared with 16.0 days(range 4–29 days) for nonsurvivors. Of the three survivors,two were successfully bridged to heart transplantation and one recovered native ventricular function.Among the three nonsurvivors,acute renal failure developed in each case, and two developed heparin-induced thrombocytopenia. This study suggests that VAD placement in patients with a prosthethic heart valve, either mechanical or bioprosthetic,appears to be a reasonable option.     

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.     

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.     

In vitro endothelialization of bioprosthetic heart valves provides a cell monolayer with proliferative capacities and resistance to pulsatile flow

OBJECTIVES: Degeneration of bioprosthetic heart valves has been suggested to be at least partly an immunogenic reaction toward the xenogeneic tissue. An autologous endothelial lining has been proposed to overcome this problem. We examined in vitro endothelialization of such tissue and retention of endothelial cells after exposure to flow resembling the in vivo situation. METHODS: Cultured human saphenous vein endothelial cells were used to in vitro endothelialize photo-oxidized bioprosthetic heart valves. The endothelialized valves were mounted in a specially designed flow device, creating a pulsatile flow through the valve. Maintenance of a confluent cell layer and deposition of basement membrane markers were determined with immunohistochemical labeling. RESULTS: Labeling of the main components of the basement membrane, laminin and collagen type IV, was verified within 6 hours after in vitro endothelialization. Under static conditions, 4-mm wide denudations were completely re-endothelialized in 4 days, which was similar to the growth rate on gelatin-coated cell culture plastic, which served as a control material. After exposure of endothelialized valves to pulsatile flows for 24 hours (80 beats/min, 3.4 L/min), there were minimal cell losses from the bioprostheses. The cell layer adapted to the pulsatile flow, as verified by rearrangement of morphology and intracellular stress fibers. CONCLUSIONS: This study shows the feasibility of in vitro endothelialization of photo-oxidized bioprosthetic heart valves. The cells are able to withstand a pulsatile flow in vitro, to develop basement membrane-like structures, and to re-endothelialize denuded areas. This technology may be used to enhance the performance of bioprosthetic heart valve prostheses.     

Redo aortic valve replacement due to early structural valve deterioration in a trifecta valve: A case report

Introduction and importanceWhile the number of SAVR cases has been increasing for patients below their sixties due to the improvement of bioprosthetic valves, some early structural valve deterioration (SVD) in Trifecta valves has been reported.Case presentationWe present a case of a female who presented with sudden shortness of breath. Ultrasonography diagnosed SVD. We performed redo aortic valve replacement due to SVD in Trifecta valve. With our surgical technique we could remove the bioprosthetic valve easily.Clinical discussionWe could easily remove the mounted prosthetic valve along with the titanium band. These cases may emerge with acute heart failure due to sudden massive aortic regurgitation, not like the gradual progression of stenosis due to calcification.ConclusionThe postoperative course in Trifecta recipients must be followed carefully.     

Long-term results of valve replacement in the right side of the heart in congenital heart disease--comparative study of bioprosthetic valve and mechanical valve

Valve replacements in the right side of the heart (TVR and PVR) were done on 16 patients with congenital heart disease, mainly tetralogy of Fallot and Ebstein anomaly. Including reoperations, 19 operations were performed on them and 20 artificial valves were inserted. Ten mechanical valves (7 St. Jude Medical valves, 3 Starr-Edwards valves) and 10 bioprosthetic valves (7 Carpentier-Edwards valves, 3 Ionescu-Shiley valves) were used. Age at valve replacement ranged from 9 to 52 years (mean 23.0 years), and the follow-up period was 1.28-19.8 years (mean 5.7 years). Including 2 sudden deaths, late death occurred in 4 patients, on all of whom mechanical valve replacements were done at the primary operation. Five-year survival rate of all patients was 76.4 +/- 12.1%, and 10-year survival rate was 63.6 +/- 15.4%. All the patients who received bioprosthesis at the primary operation survived at the time of this follow-up study. On the contrary, long-term results of mechanical valve was unsatisfactory with the 5-year survival of 62.5 +/- 17.1%. In spite of anti-coagulation therapy with warfarin, three patients with mechanical valve complicated thrombotic valves, which necessitated re-operations. Calcified bioprosthetic valve occurred in one patient with I-S valve 8.5 years after the implantation. Five-year complication-free rate was 87.5 +/- 11.7% for bioprosthesis, whereas it was 50.0 +/- 15.8% for mechanical valve (p less than 0.056). It is concluded that the bioprosthesis is the first choice for the valve replacement in the right side of the heart in congenital heart disease.     

Necessity of permanent anticoagulant therapy for isolated mitral valve replacement with bioprosthetic heart valve to prevent the postoperative thromboembolic complications

One hundred fifty four patients underwent isolated mitral valve replacement with bioprosthetic heart valve at Hyogo Medical College Hospital from November 1973 to December 1998. A porcine bioprosthetic valve was replaced in 82 patients (Hancock 43, Carpentier-Edwards 26, Hancock II 13) and pericardial bioprosthetic valve in 72 patients (Ionescue-Shiley 39, Carpentier-Edwards 33) with a mean follow-up of 1,410 patients-years. Their thromboembolism rates were also analyzed in linear and actuarial term over the 15-year period. The incidence of thromboembolism rate was 2.5%/pt.yr. Thromboembolic free rates for patients with anticoagulant therapy were significantly decreased for patients without therapy. Thromboembolic free rates for patients with atrial fibliration were also were significantly decreased for patients with sinus rhythm because the patients with sinus rhythm were not on anticoagulant therapy. In conclusion, it is necessary for the all patients to be on anticoagulant therapy after mitral valve replacement with bioprosthetic valves, even though patients with sinus rhythm.     

Bioprosthetic Versus Mechanical Valve Replacement in Patients with Infective Endocarditis

During the 5-year period, 1979-1984, at the Texas Heart Institute, 4,598 patients underwent cardiac valve replacement procedures of which 185 were for acute infective endocarditis. Staphylococcus and streptococcus accounted for 80% of the cases and congestive heart failure was a leading indication in 63%. The purpose of this article is to evaluate the recurrence of endocarditis dependent upon whether the patient had an Ionescu-Shiley bioprosthetic pericardial valve or a mechanical valve (St. Jude Medical). Actuarial freedom from both early and late reoperation was higher for prosthetic valves than bioprosthetic valve patients. We conclude that mechanical valves are the valves of choice in acute infective endocarditis which apparently is the results of less biologic tissue available for exposure to infection by the offending organisms.     

Percutaneous stent implantation to stenotic bioprosthetic valves in the pulmonary position

BACKGROUND: We evaluated stent implantation across stenotic bioprosthetic pulmonary valves in 9 patients. METHODS: Nine patients (6 male patients) underwent stent implantation across stenotic bioprosthetic pulmonary valves between July 1996 and July 1999 at the Hospital for Sick Children, Toronto. Catheter intervention was indicated if echocardiography revealed Doppler estimates of right ventricular pressure of more than two thirds of systemic arterial pressure (or systolic septal flattening with an estimated gradient of >60 mm Hg across the valve prosthesis). Catheterization was performed during general anesthesia at an age (mean +/- SD) of 9.3 +/- 3.5 years and a weight of 32.0 +/- 17.1 kg 5.9 +/- 1.8 years after surgical insertion of a bioprosthetic valve in the pulmonary position: 7 patients with tetralogy of Fallot, 1 patient with congenital pulmonary stenosis-insufficiency, and 1 patient after a Rastelli operation. All had systolic septal flattening and right ventricular dilatation with moderate-to-severe pulmonary insufficiency before intervention. Fluoroscopy times were 33.1 +/- 9.5 minutes. Seven patients received a single P4014 stent, and 2 received single P308 stents (Palmaz; Johnson & Johnson Interventional Systems, Warren, NJ) without significant complications. RESULTS: The right ventricular systemic pressure decreased acutely from 83% +/- 16% to 41% +/- 10% (P <.001, n = 9), and the transvalvular gradient decreased from 49.7 +/- 8.5 to 11.0 +/- 5.9 mm Hg (P <.001, n = 8). During the follow-up period (10.9 +/- 8.1 months, n = 8), 1 patient had an unsuccessful attempt at redilation of the stent (right ventricular pressure, 60% systemic) and underwent uneventful surgical pulmonary valve replacement. None of the remaining patients had echocardiographic evidence of systolic septal flattening, and right ventricular dimensions did not change significantly. CONCLUSION: Stent implantation is a safe and effective means of providing palliative relief of obstructed bioprosthetic valves in the pulmonary position and can safely delay the requirement for pulmonary valve replacement.     

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.     

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.     

Clinical experience with a porcine aortic valve xenograft for mitral valve replacement

Between March, 1971, and July, 1973, 103 patients underwent mitral valve replacement with a glutaraldehyde-preserved porcine aortic valve mounted on a flexible polypropylene, Dacron-covered stent. Overall operative survival was 95.1%. Actuarial analysis of late postoperative results indicates 92% survival through 2 years, with functional improvement in nearly all patients. The rate of systemic thromboembolism has been approximately 1.7% per patient-year without anticoagulants. No valve failure has occurred. We conclude that this xenograft prosthesis provides a technically and functionally satisfactory valve substitute, the durability of which appears to significantly exceed that of previously available tissue valves for mitral replacement.     

Percutaneous autologous venous valve transplantation: short-term feasibility study in an ovine model

BACKGROUND: Limited experience with bioprosthetic venous valve percutaneously inserted into femoral veins in 15 patients has been promising in short-term results only to show disappointing long-term results. Percutaneous autogenous venous valve (PAVV) transplantation was explored in an ovine model as a possible alternative treatment. METHODS: PAVV consisted of a vein segment containing a valve that was attached to a stent template. The stent templates (n = 9) were designed and hand made in our research laboratory. They consist of two stainless steel square stents 13 or 15 mm in diameter to fit the ovine jugular veins (JV), which ranges from 10 to 15 mm in diameter. A valve-containing segment of JV was harvested and attached with sutures and barbs inside the stent template (n = 9). The valve devices were then manually folded and front loaded inside the 4 cm chamber of the 13F delivery sheath and delivered into the contralateral JV by femoral vein approach. Transplanted PAVVs were studied by immediate and 3 months venograms. Animals were euthanized at 3 months, and jugular veins harvested to perform angioscopic evaluations in vitro. RESULTS: PAVV transplantation was successful in all nine animals. Good valve function with no reflux was observed on immediate and 3 months venograms in eight valves. The transplanted maximal JV diameter ranged from 10.2 mm to 15.4 mm (mean 13.1 +/- 1.5 mm). Venoscopic examination revealed intact, flexible, nonthickened valve leaflets in eight specimens. One PAVV exhibited normal function of one leaflet only; the other cusp was accidentally cut during the transplantation procedure. All transplanted autologous valves were free of thrombus and incorporated into the vein wall of the host vessel. CONCLUSION: This study demonstrated that autogenous valve transplants remained patent and competent without long-term anticoagulation for up to 3 months. The percutaneous autogenous venous valve may provide in future minimally invasive treatment for patients with chronic deep venous insufficiency, but long-term studies need to be done to document its continued patency and function.     

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.     

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.     

In vitro analysis of performance of porcine xenografts with inward bending of stent posts: real-time measurement of valve orifice area using an area meter

The influence of inward bending of the stent posts on bioprosthetic valve function was assessed in a hydromechanical simulation of the left heart. A Carpentier-Edwards mitral xenograft (31 mm) and an aortic xenograft (27 mm) were used. Valve function was evaluated before and after the stent posts were bent inward 15 degrees by suture constriction of the tops of the three posts. To evaluate the effects of the stent-post deformity on valve performance, the mean transvalvular pressure drop during steady flow, the bioprosthetic valve orifice area, and the maximum valve opening and closing speeds during pulsatile flow were measured using an area meter. Steady-flow data showed identical transvalvular pressure drops, and no significant difference in valve performance was detected in the pulsatile-flow study under the two experimental conditions (i.e., normal valve and deformed valve). We conclude that a 15-degree inward bending of the stent posts does not appreciably affect valve function in vitro.     

The glutaraldehyde-treated heterograft valve: some engineering observations.

Two commercially prepared, glutaraldehyde-treated porcine heterograft valves mounted on flexible stents have been tested in a pulsatile-flow water tunnel. Measurements of the radial deflections of the stent posts have been made for various applied pressures across the valve. A previous claim of 90 percent reduction in leaflet stress as a result of stent flexibility is of doubtful validity because the measurement technique used was inappropriate for the magnitude of strain involved. Photographs of the valve at various steady forward flow rates show that the leaflets do not open as readily as the antibiotic-treated homograft valve.     

Prosthetic replacement of tricuspid valve: bioprosthetic or mechanical

BACKGROUND: Tricuspid valve replacement is one of the most challenging operations in cardiac surgery. Selection of the suitable prosthesis is still debatable. METHODS: In our institution, between January 1980 and December 2000, 129 tricuspid valve replacements were performed in 122 patients (14.7%). Bioprosthetic valves were used in 32 patients, whereas 97 patients had mechanical valve implantation. Twenty-two percent of replacements were done on men. Mean age was 35.27+/-11.56 years. In all patients, initially an annuloplasty technique was tried. Tricuspid valve replacement was performed when annuloplasty was not sufficient. In most of the cases, tricuspid valve interventions were done under cardiopulmonary bypass and on a beating heart. RESULTS: Early mortality was 24.5%. Patients were followed for 2 to 228 months. Seven patients underwent reoperation because of tricuspid valve dysfunction (7.6%). Nine patients died during the follow-up period. Late mortality was 9.7%. Actuarial estimates of survival in 20 years of follow-up for all tricuspid prosthetic valves, mechanical valves, and bioprosthetic valves were 65.1%+/-9.3%, 68.3%+/-10.6%, and 54.8%+/-12.1%, respectively. For the bioprosthetic valve group, freedom from structural valve degeneration was 90%+/-5.5%; for the mechanical valve group, freedom from deterioration, endocarditis, and leakage was 97.8%+/-4.2%, and freedom from thromboembolism was 92.6%+/-6.9%. CONCLUSIONS: We found that there was no statistically significant difference between the two groups in terms of early mortality, re-replacement, and midterm mortality (p > 0.05). Nevertheless, we recommend low profile modern bileaflet mechanical valves for prosthetic replacement of the tricuspid valve, due to their favorable hemodynamic characteristics and durability.