Porcine Bioprosthesis Research Articles

Original expectations of the Hancock valve and 20 years of clinical reality

The standard (glutaraldehyde-preserved) Hancock porcine bioprosthesis was introduced into clinical practice in order to provide surgeons with a cardiac valve substitute which would be nonthrombogenic and therefore would not require anticoagulation, and would be durable, anatomically suitable, and noiseless. In the present report we have reviewed our long-term experience with Hancock porcine valve recipients in order to verify the original expectations of this bioprosthesis have been met.

The intact porcine bioprosthesis: early world-wide clinical experience and analysis of a single institution's experience

The intact porcine bioprosthesis: early world-wide clinical experience and analysis of a single institution's experience

The stentless bioprosthesis: surgical challenges and implications for long-term durability

An attempt is made to analyse the factors which are expected to influence clinical results following implantation of a stentless porcine bioprosthesis. Long experience with implantation of allograft aortic valves provides a meaningful basis for comparison with a glutaraldehyde-fixed device. Morphological differences between the two valves involve the aortic wall and muscle shelf, and differences in valve preparation include the strength and stiffness of the aorta and the extensibility of the valve leaflets. As a result of these differences, sizing of the porcine valve is expected to be more critical than the allograft valve and the porcine valve is also expected to be more obstructive. Methods for reducing the obstructive element include the use of a composite aortic valve, a porcine pulmonary valve, or a valve in which the aorta is glutaraldehyde-fixed under pressure while the leaflets are pressure-free. The techniques available for implantation, namely freehand insertion, total root replacement and mini-root replacement, are examined.

The intact porcine bioprosthesis: early world-wide clinical experience and analysis of a single institution's experience

The Intact porcine bioprosthesis is a new-generation valve fixed under stress-free conditions and subjected to a mineralization-inhibiting treatment. The valve is undergoing multi-centre prospective clinical evaluation sponsored by Medtronic, Inc., with 19 centres participating world wide. Since April 1986, 1465 valves have been implanted in the aortic position (AVR, n = 965), mitral position (MVR, n = 438), or both (n = 62), and followed up to 5 years. The data recorded at our participating centre, with 115 valves implanted (AVR n = 93, MVR n = 22) closely match the overall event and death rates in the prospective study. Early mortality in the overall study is 5.6% in AVR and 6.6% in MVR; 3-year actuarial survival rates are 88.5% in AVR and 85.6% in MVR; structural valve-failure-free rates at 3 years are 99.8% in AVR and 98.5% in MVR; 3-year freedom from valve-related reoperation is 97.3% in AVR and 95.8% in MVR. The preferential use of bioprosthetic valves in patients aged 70 years and older with no other indication for anticoagulant treatment entails the not infrequent occurrence of patient/prosthesis mismatch in AVR. Hence, when implanting bioprostheses in old patients, the acceptance of some mismatch has to be weighed against the freedom from anticoagulation treatment and the expected long-term freedom from structural valve failure. Further long-term follow-up will be required to demonstrate the greater durability expected from the stress-free fixation and the anti-mineralization treatment.

The hydrodynamic function and leaflet dynamics of aortic and pulmonary roots and valves: an in vitro study.

Fresh homograft aortic and pulmonary roots were tested in a pulsatile flow simulator to assess their hydrodynamic function and leaflet opening characteristics. Simultaneous flow and pressure measurements were obtained for a range of cardiac outputs. The effective orifice area and regurgitant volumes were calculated. The mean pressure difference across the pulmonary roots was obtained under both left and right side pressures. A video recording of valve leaflet function was also obtained for each valve. A comparison was made with four porcine bioprosthetic heart valves (21 and 23 mm). The mean pressure difference with respect to flow for the 21 mm Hancock II and Intact porcine bioprostheses was significantly higher than that for all aortic roots tested. The 24 mm aortic root showed significantly lower pressure drop compared to all porcine valves tested. The mean pressure difference across each pulmonary root at pulmonary pressures was significantly greater than at systemic pressures. At systemic pressures the fully open leaflets had a triangular orifice with low leaflet open bending strains at the commissures. At the lower internal pressures, with reduced dilation of the root, higher bending strains were noted. These were not as severe as seen in porcine valves.

Risk Factors of Primary Tissue Failure Within the 11 th Postoperative Year in 217 Patients with Porcine Bioprostheses

From January 1979 to December 1979, 217 patients underwent valve replacement with porcine bioprostheses. The aim of this study has been to analyze possible host-related risk factors of primary tissue failure (PTF). Of the 207 survivors, 33 have been reoperated on because of prosthetic PTF. Actuarial freedom from PTF was 67.4% +/- 6.04% at 11 years. Several clinical and prosthetic variables have been analyzed as risk factors of PTF by stratification of the event-free actuarial rates with the tests of Mantel and Breslow, and then by introducing the significant variables into the Cox proportional hazards regression model. No significance was found for serum calcium and phosphorus levels, the calcium phosphorus product, normal sinus rhythm, and anticoagulant therapy. Age less than 40 years (40.3 +/- 15.9 vs 74.2 +/- 5.7; p = 0.0348 and p = 0.03) and mitral position (57.7 +/- 7.7 vs 90.9 +/- 5.2; p = 0.0124 and p = 0.0095) were significant predictors of PTF within the 11th postoperative year. Female gender approached statistical significance (63.7 +/- 7.9 vs 72.2 +/- 9.3; p = 0.2001 and p = 0.2043). Cox multivariate analysis showed that age less than 40 years (p = 0.008) and mitral position (p = 0.015) were independent determinants of PTF. In conclusion, we have not been able to confirm the influence of metabolic host factors on the occurrence of PTF, but young age (and not only pediatric age) and mitral position are significant predisposing factors.

Hydrodynamic Function of Second Generation Porcine Bioprosthetic Heart Valves

The hydrodynamic function and leaflet dynamics of second generation porcine valves prepared with low- or zero-pressure fixation have been studied and compared to first generation porcine bioprostheses, bileaflet, and tilting disc mechanical valves. The Carpentier-Edwards Supra-Annular and Hancock II valves showed lower pressure drops than the Medtronic Intact valve and first generation porcine valves, and comparable overall energy losses to mechanical valves at normal cardiac outputs. Only the zero-pressure fixed Intact valve showed synchronous leaflet opening. Delayed leaflet opening and high opening pressures were found in both low- and high-pressure fixed porcine valves. All porcine bioprostheses showed high open leaflet bending strains. Fixation of valve leaflets with "near zero" pressure fixation and a more physiological neutral geometry is necessary to ensure synchronous leaflet opening at low flows and a reduction in commissural bending strains.

The Carpentier-Edwards Supra-Annular Porcine Bioprosthesis: Clinical Performance to 8 Years of a New Generation Porcine Bioprosthesis

The Carpentier-Edwards supra-annular porcine bioprosthesis has been utilized at the University of British Columbia since its introduction in 1982. The prosthesis was designed to improve hemodynamics with the supra-annular configuration and to reduce tissue failure with low-pressure glutaraldehyde preservation of the porcine aortic tissue. The prosthesis was inserted in 1,956 patients with 2,129 prostheses between 1982 and 1989. The mean age of the patient population was 62.7 years (range 13 to 87 years). The mean follow-up was 3.7 years per patient. The freedom from thromboembolism and antithromboembolic therapy-related hemorrhage at 8 years was 92% for aortic valve replacement (AVR), 83% for mitral valve replacement (MVR), and 92% for multiple valve replacement (MR) (p less than 0.05, AVR greater than MR greater than MVR). The freedom from structural valve deterioration was 86% for AVR, 73% for MVR, and 96% for MR at 8 years (p less than 0.05, AVR greater than MR greater than MVR). The freedom from nonstructural valve dysfunction and prosthetic valve endocarditis was not different between positions (p = NS). The freedom from valve-related mortality at 8 years was 98% for AVR, 94% for MVR, and 98% for MR (p less than 0.05, AVR greater than MR greater than MVR). The freedom from residual morbidity was not different at 8 years (p = NS). The freedom from treatment failure (valve-related mortality and residual morbidity) was 96% for AVR, 89% for MVR, and 94% for MR (p less than 0.05, AVR greater than MVR greater than MR).(ABSTRACT TRUNCATED AT 250 WORDS)

Extended Follow-Up of the Standard Hancock Porcine Bioprosthesis

We have reviewed 665 patients in whom the standard Hancock porcine bioprosthesis (HPB) was used for aortic (AVR = 173), mitral (MVR = 437), and mitral and aortic (MAVR = 55) valve replacement in the time interval from 1970 to 1983. After AVR, HPB-related deaths occurred in 24 patients (1.7% +/- 0.4% per patient-year); 11 had thromboembolic episodes (0.8% +/- 0.2% per patient-year), 6 hemorrhages related to anticoagulants (0.4% +/- 0.2% per patient-year), 9 endocarditis (0.7% +/- 0.2% per patient-year), 7 prosthetic leak (0.5% +/- 0.1% per patient-year), and 59 structural deterioration (4.3% +/- 0.6% per patient-year). At 16 years, actuarial survival is 40% +/- 6%, freedom from thromboembolic episodes 89% +/- 4%, from hemorrhages 90% +/- 5%, from endocarditis 94% +/- 2%, from prosthetic leak 95% +/- 2%, and from structural deterioration 36% +/- 6%. After MVR, HPB-related deaths occurred in 64 patients (1.6% +/- 0.2% per patient-year); 68 had thromboembolic episodes (1.7% +/- 0.2% per patient-year), 28 hemorrhages (0.7% +/- 0.1% per patient-year), 12 endocarditis (0.3% +/- 0.1% per patient-year), 9 prosthetic leak (0.2% +/- 0.1% per patient-year), and 158 structural deterioration (4.0% +/- 0.3% per patient-year). At 18 years, actuarial survival is 33% +/- 4%, freedom from thromboembolic episodes 57% +/- 13%, from hemorrhages 81% +/- 6%, from endocarditis 91% +/- 4%, from prosthetic leak 98% +/- 1%, and from structural deterioration 18% +/- 5%.(ABSTRACT TRUNCATED AT 250 WORDS)

The Carpentier-Edwards Standard Porcine Bioprosthesis: Clinical Performance to 15 Years

The Carpentier-Edwards standard porcine bioprosthesis was implanted in 1,195 patients in 1,213 operative procedures between 1975 and 1987, with the majority of implants performed prior to 1982 at the University of British Columbia. The mean age of the patient population was 57.2 years (range 8 to 85 years). The mean follow-up was 7.4 years per patient. The freedom from the combination of thromboembolism and antithromboembolic therapy-related hemorrhage at 15 years was 79.5% for aortic valve replacement (AVR), 72% for mitral valve replacement (MVR), and 84% for multiple valve replacement (MR) (p less than 0.05, AVR greater than MR greater than MVR). The freedom from structural valve deterioration at 15 years was 71% for AVR, 41% for MVR, and 41% for MR (14 years) (p less than 0.05, AVR greater than MVR greater than MR). The freedom from nonstructural dysfunction and prosthetic valve endocarditis did not distinguish the valve positions (p = NS). The freedom from valve-related mortality from all causes including reoperation was 92% for AVR, 78% for MVR, and 77% for MR at 15 years (p less than 0.05, AVR greater than MVR greater than MR). The freedom from residual morbidity was not significantly different between valve positions (p = NS). The freedom from treatment failure (valve-related mortality and residual morbidity) at 15 years was 87% for AVR, 72% for MVR, and 75% for MR (p less than 0.05, AVR greater than MR greater than MVR). The freedom from all complications at 14 years was 50% for AVR, 25% for MVR, and 27% for MR (p less than 0.05, AVR greater than MR greater than MVR).(ABSTRACT TRUNCATED AT 250 WORDS)

Massive calcification of a porcine bioprosthesis in the aortic valve position and the role of calcium supplements

Massive calcification of a porcine bioprosthesis in the aortic valve position and the role of calcium supplements

Valve-related complications with the Hancock I porcine bioprosthesis: A twelve- to fourteen-year follow-up study

Valve-related morbidity and mortality after heart valve replacement with the Hancock I porcine bioprosthesis has been retrospectively analyzed. From June 1974 through December 1976, 253 Hancock I bioprostheses (150 mitral and 103 aortic) were inserted in 220 selected patients who survived the operation and had follow-up until June 1989 (mean follow-up 13.5 years, with an accumulative follow-up of 2956.4 patient-years). One hundred seventeen patients had mitral valve replacement, 70 had aortic valve replacement, and 33 had combined mitral and aortic valve replacement. There were 27 thromboembolic events. The probability of being free from thromboembolism at 14 years was 81.0% +/- 7.4% for the mitral valve replacement group, 85.4% +/- 6.7% for the aortic group, and 67.1% +/- 18.4% for the mitral-aortic group. Fifteen episodes of prosthetic valve endocarditis occurred. There were 10 instances of nonstructural dysfunction (paravalvular leaks) in seven mitral valves (4.6%) and in three aortic valves (2.9%). One hundred twenty-two bioprostheses in 106 patients resulted in structural deterioration. The probability of freedom from structural deterioration at 14 years was 37.2% +/- 3.9% for the mitral group, 43.9% +/- 7.1% for the aortic group, and 30.1% +/- 8.9% for the mitral-aortic group. The logistic regression analysis between age at the time of operation and bioprosthetic life (structural deterioration-free period) demonstrates a linear regression curve (r = 0.53). There were 56 late deaths (27 patients died at reoperation). The actuarial survival rate (including hospital mortality) at 14 years was 57.2% +/- 5.4% for the entire series, with no statistically significant difference between groups. The probability of remaining free from valve-related morbidity and mortality at 14 years was 16.7% +/- 4.8% for the mitral group, 20.8% +/- 6.2% for the aortic group, and 14.0% +/- 7.0% for the mitral-aortic group. The long-term results of this series show that the clinical performance of the Hancock I porcine valve appears satisfactory during the first 6 years. The behavior of this bioprosthesis at 14 years' follow-up changes drastically, because only a minor group of patients is free from valve-related complications, justifying the restriction of its use for selected patients.

Twelve-Year Comparison of a Bjork–Shiley Mechanical Heart Valve with Porcine Bioprostheses

Patients undergoing heart-valve replacement may receive a mechanical prosthesis, necessitating lifelong anticoagulant treatment, or a porcine bioprosthesis, which involves no absolute need for anticoagulants. We carried out a randomized, prospective trial to compare the durability of the Bjork-Shiley mechanical prosthesis (spherical tilting-disk model) and the incidence of valve-related complications with those variables in the Hancock and the Carpentier-Edwards porcine prostheses. The mitral valve was replaced in 261 patients, the aortic valve in 211, and both in 61; the survivors have been followed up for a mean of 12 years. We found a trend toward improved actuarial survival after 12 years with the Bjork-Shiley prosthesis, but this trend was not statistically significant (group with Bjork-Shiley valve vs. group with porcine valve [mean +/- SE], 51.5 +/- 3.2 vs. 44.4 +/- 3.2 percent; P = 0.08). There was no significant difference in the actuarial incidence of reoperation after 5 years, but after 12 years significantly more patients with a porcine prosthesis had undergone reoperation (8.5 +/- 2.0 vs. 37.1 +/- 4.1 percent, P less than 0.001). An analysis combining death and reoperation as end points for an actuarial assessment of survival with the original prosthesis intact confirmed that the patients with Bjork-Shiley Shiley prostheses had improved survival (48.6 +/- 3.2 vs. 30.0 +/- 3.0 percent after 12 years, P less than 0.001). Bleeding requiring hospitalization or blood transfusion was significantly more frequent in the patients with Bjork-Shiley prostheses (18.6 +/- 3.2 vs. 7.1 +/- 2.3 percent after 12 years, P less than 0.01). There was no significant difference after 12 years in the actuarial occurrence of embolism (Bjork-Shiley vs. porcine, 21.1 +/- 3.1 vs. 26.4 +/- 3.5 percent) or endocarditis (3.7 +/- 1.4 vs 4.6 +/- 1.6 percent). Survival with an intact valve is better among patients with the Bjork-Shiley spherical tilting-disk prosthesis than among patients with porcine bioprostheses, but use of the Bjork-Shiley valve carries an attendant increased risk of bleeding associated with the need for anticoagulant treatment.

Early experience with crimped bovine pericardial conduit for arterial reconstruction

A bovine pericardial conduit was developed in the laboratory incorporating the principle of crimping used for synthetic vascular prostheses. The pericardium was processed in glutaraldehyde and the tube was crimped by a technique which preserves the integrity of collagen fibres. This vascular substitute presents a non-thrombogenic and non-porous inner surface which does not require preclotting and does not leak. The material is very soft, easy to handle and suture, coapts nicely to suture lines resulting in a hemostatic anastomosis. The crimping design provides longitudinal elasticity and resistance to collapsing, retains its shape with bending and avoids kinking. Crimping provides a circular tube which makes the construction of the anastomosis easier. Experimental studies in dogs demonstrated absence of thromboembolism with the conduit implanted in the abdominal aorta. Fibrin accumulation was not noted in the convexities of the crimps. This conduit was designed for aortic and pulmonary reconstruction and available in different sizes with or without a biological valve. Initial clinical experience included its use in 10 patients with aortic dissections or aortic aneurysms from August 1989 to March 1990. A reconstruction of the abdominal aorta was performed in 2 patients, the descending thoracic aorta in 2, the ascending aorta in 2 and the ascending aorta including the aortic valve and reimplantation of coronary arteries in 4. For the latter 4, composite crimped pericardial tubes containing a porcine bioprosthesis were used. An additional patient with a single ventricle underwent a Fontan type operation also employing a valved crimped pericardial conduit.(ABSTRACT TRUNCATED AT 250 WORDS)

Leaflet geometry and function in porcine bioprostheses

The leaflet geometry and hydrodynamic function of five porcine bioprostheses have been studied and compared to a fresh tissue porcine valve. The neutral leaflet geometries in two high pressure fixed valves (Carpentier Edwards and Hancock) and two low pressure fixed valves (Carpentier Edwards Supra-Annular and Hancock 2) had been modified during fixation and mounting. The leaflets were extended or displaced downwards towards the base of the valve, producing a higher ratio of circumferential leaflet length to inter-commissural spacing than in the fresh tissue valve. This produced high bending strains in the commissural area of the open leaflet in hydrodynamic tests. The leaflet geometry of the fresh tissue porcine valve studied was defined by a cylindrical shell inclined at approximately 27 degrees to the base of the valve and showed reduced open leaflet bending strains. Leaflet opening at low flows was dependent on leaflet geometry. Geometrical changes which are induced during mounting and fixation produced higher bending strains in the commissural area of the open leaflets. These may be contributing factors to tissue degeneration and calcification in this area.

Influence of prosthetic design on durability of the liotta porcine valve in the mitral position

From March 1979 to December 1984, the Liotta low-profile porcine bioprosthesis was employed for mitral valve replacement in 71 patients to avoid potential left ventricle-prosthesis mismatch occasionally observed with the standard, high-profile, Hancock porcine xenograft. Follow-up of 61 operative survivors showed at 10 years an actuarial survival of 67% ± 7%, freedom from thromboemboli of 96% ± 2%, freedom from structural deterioration of 63% ± 11% and freedom from all Liotta bioprosthesis-related complications of 53% ± 10%. Complications related to excessive protrusion of the stent into the left ventricular cavity were eliminated with the Liotta bioprosthesis; the peculiar stent configuration, however, was responsible for an increased rate of structural deterioration requiring reoperation in 10 patients (2.8% ± 0.9%/patient-year) at a mean interval of 76 ± 18 months after mitral valve replacement (range, 45 to 106 months). Common findings in all expiants were cusp prolapse, cusp tears, and commissural rupture related to various degrees of tissue calcification, constantly leading to severe prosthetic incompetence. As also shown experimentally, such structural changes have been attributed to increased systolic stresses on the closed cusps, favored by excessive reduction of the stent height. Our experience shows that the Liotta bioprosthesis used for mitral valve replacement does not provide any clear-cut advantage over standard porcine bioprostheses and that its long-term durability appears affected by the unique prosthetic design.

Long-term prosthesis-related and sudden cardiac-related complications after valve replacement for aortic stenosis

Predictability of prosthesis-related and sudden cardiac-related complications was examined in 630 patients who were alive 30 days after valve replacement (1965 to 1986) for aortic stenosis. Follow-up totaled 4,072 patient-years. A variety of prosthetic valves, mainly mechanical, were used. The Cox regression modal was used to identify independent risk factors and to estimate predicted event-freedoms relative to combinations of these risk factors. There were no risk factors for endocarditis (0.5 ± 0.1 [number of events per 100 patient-years ± the standard error]). Except for “other” prosthesis-related complications (0.4 ± 0.1), adversely influenced by porcine bioprostheses (n = 15) and by the Lillehei-Kaster prosthesis (n = 25), only factors underlying diseased preoperative patient/cardiac status had predictive influence. Predicted 10-year event-freedoms for low-risk versus high-risk estimate were 86% versus 73% for thromboembolism (1.7 ± 0.2), 95% versus 32% for anticoagulant-related hemorrhage (2.4 ± 0.2), 69% versus 36% for all prosthesis-related complications (5.0 ± 0.4), 93% versus 0% for sudden cardiac-related events (myocardial infarction and arrhythmia) (1.8 ± 0.2), and 66% versus 0.5% for combined prosthesis-related and sudden cardiac-related morbidity and mortality (6.8 ± 0.4). In 193 patients with coronary arteriography, coronary artery disease was a significant risk factor for each of the complication modalities examined except other prosthesis-related complications, prosthesis replacement, and endocarditis. Deciding to operate early in the course of aortic stenosis might “actively” reduce the rate of these complications.

Preservation of All Chordae Tendineae and Papillary Muscle During Mitral Valve Replacement with a Tilting Disc Valve

Mitral valve replacement was performed in 21 patients using a surgical technique that preserves the entire papillary muscle and chordal apparatus. With this technique, the anterior mitral leaflet is split from the center of the free edge toward the annulus. Bilateral incisions are made from the proximal end of this split to the two mitral commissures, detaching the anterior leaflet from the annulus. These two halves of the leaflet, with all chordae intact (corresponding to the anterolateral and posteromedial papillary muscles), are judiciously trimmed to remove areas of leaflet untethered by chordae tendineae and (when necessary) fibrous thickening; then swung posteriorly and sutured to the posterior mitral annulus using mattress sutures with pledgets. This surgical technique is expected to favor the preservation of left ventricular function and avoid occurrence of irreversible left ventricular dilation/dysfunction, and has been used successfully for calcific and degenerative etiologies, using both tilting disc valves and porcine bioprostheses. It is especially useful in the implantation of tilting disc and bileaflet mechanical prostheses because anterior subvalvular chordae tissue may interfere with the disc excursion and relocated to the posterior leaflet annulus.

Long-term performance of the Hancock porcine bioprosthesis in the tricuspid position: A review of forty-five patients with fourteen-year follow-up

Because little information is available regarding the clinical performance of the Hancock porcine bioprosthesis (Johnson & Johnson Cardiovascular, King of Prussia, Pa.) implanted in the tricuspid position, we reviewed the long-term follow-up of patients who had tricuspid valve replacement with this device. From March 1970 to December 1983, 45 patients had tricuspid valve replacement, either isolated (seven patients) or combined with replacement of other valves (38 patients) by means of a standard, glutaraldehyde-preserved Hancock porcine bioprosthesis. Follow-up ranged from 0.2 to 14.7 years (mean, 7.6 +/- 3.6 years) and was complete. The late mortality rate was 6.6% +/- 1.6%/pt-yr and the actuarial survival rate at 14 years was 23% +/- 9%. Reoperation because of structural deterioration of the tricuspid, the mitral, or both bioprostheses was performed in nine patients (3.7% +/- 1.2%/pt-yr) from 40 to 177 months (mean, 112 +/- 43 months) and resulted in no deaths. Actuarial freedom from structural deterioration of a Hancock tricuspid porcine bioprosthesis at 14 years is 68% +/- 13%. Morphologic examination of explanted porcine bioprostheses showed that those implanted in the tricuspid position had lower degrees of calcification and less severe structural changes than those simultaneously explanted from the mitral position. We conclude that the Hancock porcine bioprosthesis has an acceptable long-term durability and satisfactory performance after tricuspid valve replacement, and we continue to favor its use in the tricuspid position even in association with mechanical prostheses in the left side of the heart.

The Carpentier-Edwards standard porcine bioprosthesis: A first-generation tissue valve with excellent long-term clinical performance

The Carpentier-Edwards standard porcine bioprosthesis was implanted in 1190 patients (1201 operations, 1303 valves) between January 1975 and June 1986; most implants were before 1982. The mean age of the patients was 57.2 years (range 8 to 85 years). The early mortality was 7.6% (aortic valve replacement 5.1%, mitral valve replacement 8.8%, and multiple valve replacement 15.3%). Late mortality was 3.9% per patient-year (aortic valve replacement 3.6%, mitral valve replacement 4.2%, and multiple valve replacement 3.8%). The total cumulative follow-up period was 6737 years. Thromboembolism was 1.5% per patient-year (fatal 0.4% per patient-year) (minor 0.6%, major 0.9%); antithromboembolic therapy-related hemorrhage was 0.5% (fatal 0.1%); prosthetic valve endocarditis was 0.6% (fatal 0.2%); nonstructural dysfunction was 0.5% (fatal 0.2%); and structural valve deterioration and/or primary tissue failure was 1.5% per patient-year (fatal, 0.2% per patient-year). Thromboembolism and structural valve deterioration were the significant complications, structural valve deterioration occurring primarily between the sixth and 10th year of evaluation. The overall patient survival was 65.0% for aortic valve replacement and 54.8% for mitral valve replacement (p less than 0.05) at 10 years. The patients were classified as 92.9% New York Heart Association functional classes III and IV preoperatively and 92.3% classes I and II postoperatively. Freedom at 10 years from thromboembolism was 84.3% for aortic valve replacement and 76.5% for mitral valve replacement (p = 0.05); structural valve deterioration was 78.6% for aortic valve replacement and 71.6% for mitral valve replacement (p less than 0.05); reoperation was 74.4% for aortic valve replacement and 67.1% for mitral valve replacement (p less than 0.05). Freedom from all valve-related complications at 10 years was 58.9% for aortic valve replacement and 46.8% for mitral valve replacement (p less than 0.05); valve-related mortality was 89.5% for aortic valve replacement and 82.6% for mitral valve replacement (p = not significant); mortality and reoperation was 58.9% for aortic valve replacement and 46.8% for mitral valve replacement (p less than 0.05); mortality and residual morbidity (treatment failure) was 87.2% for aortic valve replacement and 75.1% for mitral valve replacement (p = not significant); mortality, residual morbidity, and reoperation were 66.3% for aortic valve replacement and 54.9% for mitral valve replacement (p less than 0.05). The standard Carpentier-Edwards porcine bioprosthesis has provided satisfactory clinical performance and has afforded patients excellent quality of life.