Homologous dura mater cardiac valves

Homologous dura mater cardiac valves

Homologous dura mater cardiac valves Study of 533 surgical cases A group of 533 patients had cardiac valves replaced with homologous dura mater valves...

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Homologous dura mater cardiac valves Study of 533 surgical cases A group of 533 patients had cardiac valves replaced with homologous dura mater valves. The dura mater was preserved in a solution of 98 per cent glycerol and antibiotics for a period of 12 days before use. The leaflets were mounted in a stainless steel ring covered by Dacron velour. Two hundred forty-five patients had mitral valve replacement; 205 patients, aortic valve replacement; 17 patients, tricuspid valve replacement; and 2 patients, pulmonary valve replacement. Sixty-four patients were subjected to multivalvular replacements. The patients were followed for a period of 1 to 40 months after surgery satisfactory clinical and hemodynamic results. Because 2 patients developed endocarditis produced by fungii, fungicidal drugs were added to the preservative solution. No bacterial endocarditis has been observed. No pressure gradient through the valve has been noted at rest. Anticoagulant drugs have not been used in the postoperative period.

with

L. B. Puig, G. Verginelli, K. Iryia, L. Kawabe, G. Bellotti, E. Sosa, F. Pilleggi, and E. J. Zerbini, Sao Paulo, Brazil

IVJLany improvements have been introduced in the manufacture of cardiac valve prostheses. Moreover, the incidence of postoperative thromboembolisnr" "■ "• -*• - 4 > 28,30 and other complications has stimulated investigations of the use of biological tissues in the manufacture of cardiac valves.1"1' 7' ,J - n ' -"' -(i' "'• :il The satisfactory results observed after replacement of heart valves by homologous dura mater tissue have encouraged our group11"1"' -7 to use this material. The first patient of the present series was operated upon in January of 1971. The dura mater valve was employed for the replacement of this mitral, aortic, tricuspid, or pulmonary valve, and a group of patients was followed for a period of 40 months. Clinical material and method A group of 533 patients was subjected to the replacement of cardiac valves by dura From the Heart Institute, Hospital das Clinicas, University of Sao Paulo (Professors E. J. Zerbini and L. V. Decourt), Sao Paulo, Brazil. Received for publication June 21, 1974.

722

mater valves at our institution during the period between January, 1971, and May, 1974 (Table I ) . The patients were subjected to total cardiopulmonary bypass with cardiac anoxic arrest, and the heart valves were replaced by a technique similar to that employed for implantation of a Starr-Edwards prosthesis. Fig. 1 shows the dura mater valve with separate leaflets mounted in a stainless steel ring covered by Dacron velour. The patients' ages ranged from 3 to 80 years; 285 were male and 248 female. From the total group of 533 operated patients, 449 (84.2 per cent) are alive. The durations of observation of the survivors vary as follows: 1 to 24 months, 363 patients; 25 to 36 months, 65 patients; and 37 to 40 months, 21 patients. During the late postoperative re-evaluation, a group of 32 patients was submitted to hemodynamic studies. Results The immediate mortality rate for the total group was 12.8 per cent and the late

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Fig. 1. Dura mater valve mounted in a stainless steel ring covered by Dacron velour. A, Concave aspect. B, Convex aspect.

Table I. Cardiac valve replacement by dura mater valve Replaced valves

Fig. 2. Dura mater valve 5 months after implantation in the mitral ring. There are stitches around the struts of the valve which held and ruptured the dura mater cusps. There is no degeneration of the biological valve tissue. mortality rate, 3 per cent. In 1 patient, the left ventricular wall was perforated by the strut of the dura mater valve during the operation. Two deaths observed during the immediate postoperative period were directly related to the valve and were produced by fungal endocarditis. The remaining deaths were due to causes not directly related to the dura mater valve. During the postoperative period, some nonlethal complications related to the valve were observed. In the group of 245 patients who required mitral replacement, 9 patients had a systolic murmur after the

Patients No. Per cent

Mitral Aortic Tricuspid Pulmonary Mitral and aortic Mitral and tricuspid Aortic and tricuspid Mitral, aortic, and tricuspid Miscellaneous (dura mater and Starr-Edwards)

245 205 17 2 41 14 1 2

46.0 38.4 3.1 0.3 8.0 2.6 0.1 0.4

6

1.1

Totals

533

100.0

operation (Table II). Four patients in this group underwent a second operation: One of them (Case 1) had leakage through the stitches at the mitral ring. In another (Case 7) the dura mater leaflet ruptured at the area of the commissural suture. In 2 patients (Cases 2 and 3), rupture of the dura mater cusps was caused by misplacement of a stitch during the operation (Fig. 2). The remaining 5 patients (Cases 4, 5, 6, 8, and 9) were followed for 2 years or more, and auscultation or the phonocardiographic patterns showed that the systolic murmur was of the same intensity as just after the operation. In the group of 205 patients who had aortic valve replacement, 4 patients required a second operation for a diastolic

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Table II. Postoperative systolic murmur in the mitral area Severity of murmur Late

Period of evolution

+



15 da.

Suture leakage

2

++

++

5 mo.

Misplaced stitches

3

+

+++

19 mo.

Misplaced stitches

4 5 6 7

+ + + +

+ + + +++

24 mo. 30 mo. 31 mo. 35 mo.

Imperfection of valve Not identified Not identified Rupture of cusp

8 9

+ +

+ +

36 mo. 37 mo.

Imperfection of valve Not identified

Case No.

Immediate

1

Cause of murmur

Evolution Reoperation; stitches replaced; patient still symptomatic Replacement by another dura mater valve; asymptomatic Replacement by another dura mater valve; asymptomatic No reoperation; asymptomatic No reoperation; asymptomatic No reoperation; asymptomatic Replacement by another dura mater valve; asymptomatic No reoperation; asymptomatic Without insufficiency during cineangiocardiographic study; asymptomatic

Table III. Postoperative diastolic murmur in the aortic area Severity of murmur

Case No.

Immediate

Late

Period of evolution

1

+



30 da.

Suture leakage

2



++

7 mo.

Imperfection of valve

3



++

13 mo.

Imperfection of valve

4



++

22 mo.

Suture leakage

Cause of murmur

aortic murmur (Table III). In two instances the insufficiency was produced by leakage through stitches at the aortic ring (Case 1 and 4 ) . In 2 other cases the insufficiency was produced by imperfect manufacture of the valve (Cases 2 and 3 ) . In the group of patients subjected to pulmonary (2 cases) or multiple valve replacement (58 cases), there were no immediate or late postoperative complications related to the valve. In the group of 17 cases of tricuspid valve replacement, 1 patient with Ebstein's anomaly developed a mild tricuspid systolic murmur caused by peripheral leakage. The leak was observed in the cineangiocardiographic study.

Evolution Replacement by Starr-Edwards prosthesis; death from myocardial insufficiency Replacement by another dura mater valve; asymptomatic Replacement by another dura mater valve; death from myocardial insufficiency Stitches replaced in the dura mater valve; asymptomatic

During the late period after mitral valve replacement, 3 patients with chronic atrial fibrillation and huge left atria developed complications: One sustained a reversible episode of cerebral ischemia and the other 2 had ischemia of the leg, possibly produced by thrombi released from the left atrial wall. Anatomic and pathological studies Seven dura mater valves were studied in the late postoperative period: 1, 2Vi, 5, 7, 13, 19, and 35 months after implantation. The macroscopic aspects of the dura mater were similar in every case, and no degeneration of the leaflets was observed. The dura mater valve studied 35 months

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Fig. 3. Histologic study of the dura mater leaflet 35 months after implantation demonstrates the normal aspect of the dura mater in the area of rupture. (A). The groove produced by the stitch is shown by the arrow (B). (Original magnification x25.)

Fig. 4. Histologic aspect of the dura mater leaflet (same case as in Fig. 3) demonstrates the preserved structure of the collagenous tissue without cell infiltration or edema. (Original magnification x65.)

after operation had a rupture of one leaflet in the commissural area (Case 7, Table II). The macroscopic aspect of the cusps was normal, and their thickness and flexibility was preserved. There was no evidence of degeneration. Histologic study showed a granulated surface at the area of rupture, with small fibrin deposits and fragments of stitches. There were a few histiocytes but no giant cells. The characteristic fasciculated appearance of the dura mater remained (Figs. 3 and 4 ) . At the edges of the dura mater cusps, a small layer (1 or 2 mm.) of fibrous tissues was observed.

Discussion The advantages and disadvantages of valvular prosthesis and biological valves used for the replacement of cardiac valves have been extensively discussed."' '"■ -'• -■'• '■"'• " The late postoperative results observed with the homologous dura mater valves have been gratifying, and the postoperative hemodynamic and angiocardiography data are satisfactory." '"• -7 In the present group of 533 patients who had cardiac valves replaced by the dura mater valve, 57 (10.7 per cent) had sustained thromboembolic episodes after

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Fig. 5. Normal aspect of the dura mater valve 3 months after surgery in a patient with chronic atrial fibrillation. Thrombi were observed in the atrial wall (arrow).

replacement of their valves with a StarrEdwards prosthesis. They subsequently had the prostheses replaced. Three patients (0.56 per cent) had the aortic valve replaced with an aortic homologous valve and were reoperated upon to have the insufficient valve replaced with a dura mater valve. Four patients with Ebstein's anomaly and 2 patients with pulmonary agenesis received dura mater valves. In five instances the dura mater valve had to be replaced by a new dura mater valve as a result of mitral or aortic insufficiency. In two instances (Cases 2 and 3, Table III), we found during the second operation that a misplaced stitch encircled the struts and had cut the cusp away from the struts. One patient (Case 2) had a mild systolic murmur after the operation, which suggested immediate mitral insufficiency. In Case 3 the moderate systolic murmur heard in the immediate postoperative period increased later. In 2 additional patients (Cases 2 and 3, Table III) the cause of the valvular insufficiency was recognized to be an imperfection of the valve manufacture. In these valves, very little of the dura mater was sutured to the Dacron valour ring; as a result the cusp tore several months later. In 1 patient (Case 7, Table II), the cusp

had ruptured near the commissure. Although in the mentioned cases the malfunction could be considered a result of deterioration of the valves, no degeneration of the dura mater tissue was observed when the valves were harvested. During the manufacture of the valve, care must be taken in the selection of the areas of dura mater to be used. The macroscopic aspect, thickness, and flexibility of the tissue must be considered. In 4 cases the small degree of insufficiency observed after surgery was caused by imperfection of the valve. Five patients who underwent mitral valve replacement had satisfactory late results in spite of the systolic murmur observed after the operation. Our experience has underscored the poor results obtained with fascia lata in the tricuspid position.--' -•"' The results with dura mater in the replacement of the tricuspid valve have been satisfactory. In a series of 17 patients, 11 are alive and none have died in the late postoperative period. Two patients of this group have normal nemodynamic status 3 years after the operation. The postoperative hemodynamic studies in a group of 32 patients demonstrates no significative gradient of pressure in the aortic, mitral, or tricuspid position.

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The dura mater valves recovered from patients at the postmortem examinations or reoperations have had normal leaflets with preserved fibroelastic components. No calcification, fibrosis, or thrombosis was observed on the valves. In 1 case, thrombi were observed in the left atrium and left atrial appendage. This patient had a large atrium plus atrial fibrillation and died of arrhythmia and cardiac insufficiency (Fig. 5). During the preparation of the valve, a sample of dura mater is always submitted to bacteriologic culture. In every case the culture was negative, demonstrating the sterilizing protection offered by the solution of glycerol and antibiotics used (cephaloridine and kanamycin).'-'• "• 1!i In the group of 533 patients studied, no case of bacterial endocarditis was observed. Two patients developed endocarditis produced by fungii (Aspergillus fumigatus) after surgery. To avoid this complication, amphotericin B was added to the preservative solution. No thromboembolic complications have been observed after the replacement of cardiac valves by dura mater valves. Because of this observation, the use of anticoagulants was discontinued after the first case. At present, no anticoagulant therapy is used. However, there were 3 patients with huge left atria and atrial fibrillation who sustained peripheral embolic episodes. One patient had loss of consciousness and 2 had ischemia of the lower limb. These patients recovered from the complications with conservative treatment and without anticoagulants. Small thrombi from the left atrial wall were the causes of the ischemic phenomena. REFERENCES 1 Angel, W. W.: The First International Workshop on Tissue Valves, Ann. Surg. 172: 8, 1970 (Suppl.). 2 Barratt-Boyes, B. G.: Homograft Aortic Valve Replacement in Aortic Incompetence and Stenosis, Thorax 19: 131, 1964. 3 Barratt-Boyes, B. C : Long-Term Follow-up of Aortic Valvar Grafts, Br. J. Surg. 3 3 : 60, 1971 (Suppl.). 4 Binet, J. P., Duran, C. G.: Carpentier, A.,

and Langlois, S.: Heterologous Aortic Valve Transplantation, Lancet 2: 1275, 1965. 5 Bjork, V. O., and Malers, E.: Total Mitral Valve Replacement: Late Results, J. THORAC. CARDIOVASC. SURG. 48: 625,

1964.

6 Duvoisin. G. E., Brandenburg, R. O., and McGoon, D. C : Factors Affecting Thromboembolism Associated With Prosthetic Heart Valves, Circulation 35, 36: 70, 1967 (Suppl. I). 7 Fadali, A. M., Ramos, M. D., Topaz, S. R., and Gott, V. L.: The Use of Autogenous Peritoneum for Heart Valve Replacement, J. THORAC.

CARDIOVASC.

SURG.

60:

188,

1970.

8 Garamela, J. J., Lynch, M. F., Schmidt, W. R., and Jensen, N. K.: Fatal Clotting of the Starr-Edwards Mitral Ball Valve Nineteen Months

Postoperatively,

VASC. SURG. 47: 673.

J. THORAC.

CARDIO-

1964.

9 Geha, A. S., Salaymeh, M. T., Davies, G. L., and Baue, A. E.: Replacement of Aortic Valve With Molded Autogenous Grafts Grown in Response to Implanted Silastic, J. THORAC. CARDIOVASC. SURG. 60: 661,

1970.

10 Ionescu, M. I., Ross, D. N., Deac, R., Grimshaw, V. A., Taylor, S. H., Whitaker, W., and Wooler, G. H.: Autologous Fascia Lata for Heart Valve Replacement, Thorax 25: 46, 1970. 11 Ionescu, M. I., Wooler, G. H., Smith, D. R., and Grimshaw, V. A.: Mitral Valve Replacement With Heterografts in Humans, Thorax 22: 305, 1967. 12 Pigossi, N.: Implantacao de dura-mater homogena conservada em glicerina. Estudo experimental em caes, Sao Paulo, 1964, Thesis, Faculty of Medicine University of Sao Paulo. 13 Pigossi, N.: A glicerina na conservacao de dura-mater. Estudo experimental, Sao Paulo, 1967, Doctoral Thesis, Faculty of Medicine University of Sao Paulo. 14 Puig, L. B.: Substituicao da valva aortica por valva de dura-mater homologa, Sao Paulo, 1972, Thesis, Faculty of Medicine University of Sao Paulo. 15 Puig, L. B., Verginelli, G., Bellotti, G., Kawabe, L., Frack, C. C. R., Pilleggi, F., Decourt, L. V., and Zerbini, E. J.: Homologous Dura Mater Cardiac Valve: Preliminary Study of 30 Cases, J. THORAC CARDIOVASC. SURG. 64:

154,

1972.

16 Puig, L. B., Verginelli, G., Bellotti, G., Kawabe, L., Marcial, M. B., Sosa, E., Macruz, R., and Zerbini, E. J.: O uso da dura-mater homologa em cirurgia cardiaca, Arq. Bras. Cardiol. 26: 295, 1973. 17 Puig, L. B., Verginelli, G., Kawabe, L., Gregori, F., Jr., Melo, R., Decourt, L. V., and Zerbini, E. J.: Valvulas de dura-mater homologa. Estudio de 237 casos, Eleventh

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World Congress of the International Cardiovascular Society, Barcelona, Espafia, 1973. 18 Puig, L. B., Verginelli, G., Kawabe, L., and Zerbini, E. J.: Valva cardiaca de dura-mater homologa, Rev. Hosp. Clin. Fac. Med. Univ. Sao Paulo 29: 85, 1974. 19 Puig, L. B., Verginelli, G., Bellotti, G., Sosa, E., Kawabe, L., Pileggi, F . , and Zerbini, E. J.: Substituicao da valva aortica por valva de dura-mater, Rev. Hosp. Clin. Fac. Med. Univ. Sao Paulo, 29: 3, 1974. 20 Ross, D. N . : Homotransplantation of the Valve in the Subcoronary Position, J. THORAC. CARDIOVASC. SURG. 47: 713, 1964.

21 Senning,

A.: Fascia

Lata

Aortic Valves, J. THORAC.

Replacement of CARDIOVASC. SURG.

54: 465, 1967. 22 Shumacker, H. B, Jr.: Autogenous Tissue Cardiac Valves, Surgery 70: 848, 1971. 23 Starr, A.: Discussion of paper by Magovern, G. J., Kent, E. M., Cromie, A. W., Cushing, W. B., and Scott, S.: Sutureless Aortic and Mitral Prosthetic Valves, J. THORAC. CARDIOVASC. SURG. 48: 360, 1964.

24 Starr, A., Herr, R. H., and Wood, J. A.: Mitral Replacement: Review of Six Years' Experience, J. THORAC.

CARDIOVASC. SURG. 54: 333,

1967. 25 Trimble, A. S.: First International Roundtable on Fascia Lata Heart Valves, Surgery 7 1 : 10, 1972.

26 Van Der Spuy, J. C : Completely Anatomical Autogenous Whole Mitral Valve, Thorax 19: 526, 1964. 27 Verginelli, G.: Substituicao da valva atrioventricular por valva de dura-mater, Sao Paulo, 1972, Thesis, Faculty of Medicine University of Sao Paulo. 28 Verginelli, G., Barbero-Marcial, M., Puig, L. B., Piantino, P. C , Sosa, E., Bittencourt, D., and Zerbini, E. J.: Substituicao da valva aortica pela protese de Starr-Edwards. Experiencia em 332 casos operados, Arq. Bras. Cardiol. 24: 15, 1971. 29 Verginelli, G., Martin, J., Barbero-Marcial, M., Macruz, R., and Zerbini, E. J.: Preliminary Valve Insufficiency in a Case of Tetralogy of Fallot After Brock's Operation: Correction by Heterologous Aortic Graft, J. THORAC.

CARDIOVASC. SURG. 62: 436, 1971.

30 Zerbini, E. J., Jatene, A. D., Bittencourt, D., Pileggi, F., and Oliveira, S. A.: Tratamento cirurgico das lesoes adquiridas da valvula mitral, Gaz. Sanit. 1: 2, 1968. 31 Zerbini, E. J., Oliveira, S. A., Pileggi, F., Bittencourt, D., Verginelli, G., Bellotti, G., Macruz, R., and Decourt, L. V.: Early Results of Aortic Valve Homografts Replacement, Chest 55: 32, 1969.