Intermediate results of isolated mitral valve replacement with a Biocor porcine valve

BACKGROUND: We analyzed the intermediate experience, survival, and prosthetic complications of patients who received the Biocor valve, a new-generation porcine valve, in the mitral position. METHODS: At the University of Padua, between May 1992 and January 2004, 154 consecutive patients (102 female and 52 male patients; mean age, 72.3 +/- 6 years; age range, 37-86 years) received 158 mitral Biocor prostheses (Biocor Industria e Pesguisa Ltda, Belo Horizonte, Brazil). Thirty-five percent of the patients had previous mitral operations, 24% had coronary artery bypass grafting, and 34.6% had other procedures. Median preoperative New York Heart Association class was III. Echocardiography was performed in 75% of the long-term survivors. Follow-up included 609.4 patient-years and was 100% complete, with a median time of 4 patient-years (range, 0.02-11.3 years). At 8 years, 20 (14%) of 142 operative survivors were still at risk. RESULTS: Early mortality was 13.6%. According to univariate analysis, New York Heart Association class III to IV, ejection fraction of less than 40%, urgency, male sex, and coronary artery bypass grafting were significant perioperative risk factors. Eight- and 10-year actuarial survival was 51.1% +/- 5.6% (40 deaths). Eight-year actuarial freedom from valve-related death, thromboembolism, anticoagulant-related hemorrhage, endocarditis, paravalvular leak, and valve-related complications were 85.2% +/- 5%, 85.7% +/- 4.4%, 92.6% +/- 3.7%, 94.1% +/- 3%, 91.8% +/- 3%, and 70.2% +/- 5.7%, respectively. Freedom from structural valve deterioration was 100%. Actual freedom from reoperation was 93.2% +/- 2.2%. By Doppler echocardiography, the peak and mean transprosthetic gradients were 15 +/- 5 mm Hg and 6.3 +/- 3 mm Hg, respectively (mean follow-up, 4.2 +/- 2.7 years). CONCLUSION: At intermediate follow-up, the Biocor prosthesis in the mitral position showed excellent results in terms of valve durability when compared with other second-generation tissue valves.     

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.     

Early degeneration of a bioprosthetic mitral valve complicated by a large left atrial thrombus

The authors report the case of a patient with symptomatic early bioprosthetic mitral valve deterioration in the setting of calcium supplementation. This was further complicated by a large left atrial thrombus despite supratherapeutic anticoagulation and a previously oversewn left atrial appendage. As mechanical valves are less predisposed to calcification in comparison with bioprosthetic implants, the patient underwent a mechanical mitral valve replacement in addition to a left atrial thrombectomy.     

Performance of glutaraldehyde-preserved porcine bioprosthesis as a mitral valve substitute in a young population group

Porcine bioprostheses were implanted in the mitral position in 289 patients. The mean age was 25.8 +/- 13.7 years. One hundred thirty-five patients (47%) were 20 years old or younger. Most patients had chronic rheumatic valvulitis (74%). Mitral regurgitation and mixed mitral valve disease were the dominant lesions. Hancock, Angell-Shiley, and Carpentier-Edwards prostheses were implanted in 84, 14, and 191 patients, respectively. There were 19 early and 64 late deaths. Mean follow-up was 5.04 +/- 1.03 patient-years. Fifty-eight patients (6.71% per patient-year) were reoperated on for degenerated prostheses, with 13 deaths. Twelve patients died without reoperation, and 17 await reoperation for degenerated valves. The rate of structural failure (total, 87 patients) was 21.07% and 3.04% per patient-year for patients less than and older than 20 years, respectively (p less than 0.001). The 6-year actuarial survival for these two groups was 50% and 68%, respectively. However, for patients 20 years old or younger, survival free from degeneration was only 20% at 6 years (p less than 0.001). Bioprostheses have a high failure rate and should not be implanted in young patients or in patients with a life expectancy exceeding 10 years.     

A 10-year comparison of mitral valve replacement with Carpentier-Edwards and Hancock porcine bioprostheses

Two hundred fifty-three patients who underwent isolated mitral valve replacement with a porcine bioprosthesis had long-term evaluation. One hundred forty-seven patients received a Carpentier-Edwards porcine bioprosthesis and 106, a Hancock valve. There were no significant differences in preoperative clinical characteristics between the two groups. Cumulative follow-up was 1,375 patient-years. At 10 years, 93% +/- 2.5% of the patients in the Carpentier-Edwards group and 85% +/- 7.8% of those in the Hancock group were free from valve-related death (not significant), and 95% +/- 2% and 91% +/- 3.8%, respectively, were free from thromboembolism (not significant). At 10 years, 65% +/- 7.2% of the patients in the Carpentier-Edwards group and 66% +/- 7.2% of those in the Hancock group were free from structural valve deterioration (not significant), and 64% +/- 6% and 59% +/- 7.3%, respectively, were free from reoperation (not significant). We conclude that the first generation of Carpentier-Edwards and Hancock prostheses produce comparable long-term results in the mitral position.     

Clinical comparison of St. Jude and porcine mitral valve prostheses

One hundred and six consecutive patients who had mitral valve replacement with either a St. Jude or porcine heterograft prosthesis were prospectively studied. The 2 groups are similar with respect to 67 clinical and operative factors and allow comparison of valve performance as an independent variable. Total follow-up is 3,312 patient-months (mean 36 months, range 2-57 months, 94% complete). There are no statistical differences in symptomatic improvement or mortality by life table analysis. Valve-related complications expressed as percent per patient-year are: reoperation: 1.8 St. Jude and 3.8 porcine; endocarditis: 1.2 and 1.9; regurgitant murmur: 2.3 and 1.9; hemolysis: 1.8 and 0.0; late thromboembolism: 1.8 and 1.0; hemorrhage: 2.9 and 2.9; and valve failure: 0.0 and 1.0. There were no significant differences found. Actuarial survival at 3 years was 78% in St. Jude and 81% in porcine patients. Forty-six percent of patients with St. Jude valves and 55% of patients with porcine valves were alive and free of all complications at latest follow-up. The clinical performance of St. Jude and porcine mitral valves are similar over this period of intermediate follow-up.     

A case of mitral valve replacement with a collar-reinforced prosthetic valve for heavily calcified mitral annulus.

Mitral valve replacement in the presence of extensive calcification of the mitral annulus is a technical challenge. Dense calcification of the annulus can cause a great difficulty in the insertion of a prosthetic valve and later periprosthetic leakage. A radical calcium debridement may cause left circumflex coronary artery injury, atrioventricular rupture, and thromboembolic events. We report a case of a 65-year-old woman suffering from mitral regurgitation with a severely calcified mitral annulus. She underwent mitral valve replacement using a collar-reinforced prosthetic valve, which allowed the surgeon to safely insert a prosthetic valve, avoiding the calcification completely without any major complications. We recommend this method as a feasible technique for mitral valve replacement in the presence of heavily calcified or disrupted fragile mitral annulus.     

A comparison of mitral valve reconstruction with mitral valve replacement: intermediate-term results

The continued good results after mitral valve reconstruction prompted this retrospective study to compare operative and late results from our institutional experience since 1976 with 975 porcine mitral valve replacements (MVRs) (1976 to December 1987), 169 mechanical MVRs (1976 to December 1987), and 280 Carpentier-type mitral valve reconstructions (CVRs) (1980 to mid-1988). The operative mortality was 2.0% for isolated CVR, 6.6% for isolated mechanical MVR, and 8.5% for isolated porcine MVR. The overall operative mortality was 5.0% for CVR, 16.6% for mechanical MVR, and 10.6% for porcine MVR. The overall 5-year survival including hospital deaths was 76% for CVR, 72% for mechanical MVR, and 69% for porcine MVR. By multivariate analysis, the predictors of increased operative risk and of decreased survival were age, New York Heart Association functional class IV status, previous cardiac operation, and performance of concomitant cardiac surgical procedures. The type of valvular procedure was not predictive of operative risk or overall survival. The 5-year freedom from reoperation was 94.4% for nonrheumatic patients having CVR, 77.4% for rheumatic patients having CVR, 96.4% for mechanical MVR, and 96.6% for porcine MVR (p less than 0.05, rheumatic patients with CVR versus both MVR groups). The 5-year freedom from all valve-related morbidity and mortality was significantly better for valve reconstruction compared with both types of valve replacement. Thus, the operative risk and late survival obtained after mitral valve reconstruction were at least equivalent to those obtained after MVR. In addition, patients receiving mitral valve reconstruction had less valve-related combined morbidity than patients receiving valve replacement, thus making mitral valve reconstruction preferable in some patients with mitral insufficiency.     

A novel stentless mitral valve

Stentless mitral valves have found little clinical utility to date due to difficulty in insertion. A new design for a stentless mitral valve, a modification of an existing aortic stentless prosthesis, is described. The new design mimics the native mitral physiology, and its insertion is easier than with existing stentless mitral valves. Commercially available stentless aortic valves were inserted into 2 pigs. The valves were modified so that the commissural posts were restrained. The valves were partially recessed into the left ventricular cavity, secured to the annulus, and anchored to the native papillary muscles. Both pigs were weaned from bypass successfully, and both valves functioned normally with trace regurgitation noted on echocardiography. This design affords the benefit of the reapproximation of native physiology. Preservation of papillary-annular continuity should allow maximal left ventricular function. Lack of a stent should allow avoidance of long-term anticoagulation.     

Pathology of the formalin-treated heterograft porcine aortic valve in the mitral position

The mitral valve was replaced by a pig aortic valve in 33 patients at Groote Schuur Hospital. Eleven of the failed heterograft aortic valves were examined at intervals of from 2 to 32 months after insertion. Fourteen control pig aortic valves were also examined. Electron microscopy was performed on two of the failed heterograft valves and three control pig valves. Failure of the heterograft was due to stretching and deformation of the cusps with resultant valvular incompetence. Stretching of the cusp was a result of reduction in the amount of its collagen content. The elastic tissue appeared little altered. A microscopic layer of fibrin thrombus was present on the surface of 8 of the 11 valves. Only 2 of the 11 valves showed invasion of the graft by immunologically competent cells. No valve showed any sign of infection or calcification. The denatured collagen of the heterograft has a low antigenicity and also, infortunately, a limited durability.     

Prevention of thromboembolism using aspirin after mitral valve replacement with porcine bioprosthesis

The thromboembolic rate of 768 patients who were treated only with aspirin after mitral valve replacement or mitral plus aortic valve replacement with porcine bioprostheses was evaluated. We analyzed the thromboembolic rate for the whole series and for subgroups of patients categorized by atrial fibrillation, giant left atrium, left atrial thrombosis, and dosage of aspirin (1 gm daily or 0.5 gm every 48 hours). The total embolic rate was 1.4% (11/768). No patient in sinus rhythm had an embolic event. The embolic rate for patients in atrial fibrillation was 1.9% (11/583). There were no embolic events in 31 patients with a giant atrium. An embolic event occurred in 1 of 42 patients with atrial thrombosis (2.4%). Patients treated with 1 gm of aspirin daily had a 3% embolic rate (9/295) while the incidence was 0.4% (2/473) in those treated with 0.5 gm every 48 hours (p less than 0.01). Administration of aspirin after mitral valve replacement with a bioprosthesis is a very effective treatment for prevention of thromboembolism. In our experience, this treatment provides protection equal to or better than that offered by oral anticoagulants for patients in atrial fibrillation as well as for patients with a giant atrium or atrial thrombosis at operation. The dosage and timing of aspirin administration may markedly affect the result of this type of treatment. Oral anticoagulation with coumarin derivatives may not be appropriate after mitral valve replacement with a bioprosthesis, and platelet antiaggregates should be used for this purpose in the future.     

A clinical comparison of mitral valve repair versus valve replacement in ischemic mitral regurgitation

Severe mitral regurgitation caused by acute myocardial infarction has been a particularly difficult management problem with disappointing clinical results. Over a 75-month period, ending March 31, 1987, 611 patients underwent mitral valve operations at Duke University Medical Center. Within this group, 55 patients had clearly defined ischemic mitral regurgitation, and 37 of these required emergency operations. Thirty-one of the 55 patients had isolated posterior papillary muscle dysfunction, nine had papillary muscle rupture, and 15 had severe ventricular dysfunction and generalized annular dilatation. Thirty-two patients were treated with primary mitral valve replacement, and 23 had mitral valve repair. In 18, repair was accomplished by a transventricular approach, combining the techniques of commissural annuloplasty, papillary muscle shortening or reimplantation, and infarct exclusion. Transventricular mitral valve repair proved to be safe, expeditious, and effective in restoring valve competence. Although the repair and replacement groups were similar with respect to all relevant baseline characteristics, improved operative survival was observed after valve repair, as compared to replacement, both for the overall group (p = 0.03) and for acute papillary muscle dysfunction (p = 0.05). These data suggest that a policy of predominant mitral valve repair, when appropriately applied in patients with ischemic mitral regurgitation, offers the potential for improving therapeutic results.