Extended survival after mitral valve replacement with a Gott-Daggett prosthesis.
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Biomedical subjects
Publications and source records attributed to U Bortolotti.
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Sixty-seven glutaraldehyde-processed porcine bioprostheses (PBs), recovered at autopsy or reoperation from 65 patients, were evaluated by roentgenologic and pathologic examination. Seven patients with 8 PBs were younger than 20 years of age. The time interval of function was 2 to 138 months (average 62). Pathologically, 53 explants had signs of intrinsic dysfunction, which was ascribed to calcification in 36 (68%). By x-ray examination, calcific deposits were found in 55 of 67 PBs (82%). The mean duration of function was 70 +/- 32 months in calcified PBs vs 27 +/- 18 months in noncalcified PBs (p less than 0.001). All 26 PBs that had been in place for longer than 6 years were calcified. In 45 PBs the Ca++ deposits were considered severe (mean time of function 76 +/- 32 months) and mild in 10 (mean time of function 44 +/- 22 months) (p less than 0.005). The Ca++ deposits were located at the commissures in 54 PBs (98%), at the body of cusps in 41 (75%), at the free margin in 37 (67%) and at the aortic wall in 37 (67%). When mild, Ca++ deposits involved the commissures in 90% of cases, the body of cusps in 30% and the free margin only in 10%. Forty-seven calcified PBs were mounted on a flexible stent, and 8 had a rigid stent, with an average time of function of 63 +/- 28 and 113 +/- 18 months, respectively (p less than 0.00001). Ca++ dysfunction occurred earlier in the aortic than in the mitral position (59 +/- 19 vs 86 +/- 35 months, p less than 0.05). All the PBs explanted from young patients and 47 of 59 PBs removed from adult patients were calcified, with an average time of function of 50 +/- 21 vs 73 +/- 33 months, respectively (p less than 0.05).(ABSTRACT TRUNCATED AT 250 WORDS)
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To obtain a valve with better hemodynamic performance and longer durability than the currently available bioprostheses, a single-cusp pericardial xenograft has been developed. This valve has been tested extensively both in vitro, in a pulse duplicator and in a fatigue-testing system, and in vivo, in a series of dogs and sheep. Hemodynamic studies showed improved hemodynamic performance compared with other biological and mechanical valves. Effective orifice areas were larger and performance indexes higher, especially in the small sizes. Accelerated fatigue testing showed durability significantly superior to that of other biological devices. Animal experiments have established that the single cusp remains pliable even after more than two years of insertion. There is a low incidence of calcification and good preservation of the collagen matrix. This preliminary experience demonstrates that the unicusp pericardial xenograft has superior hemodynamics, increased resistance to fatigue-induced lesions, and a low incidence of calcification. These results might indicate an extended in vivo durability for this device.
Four hundred seventy-six patients underwent isolated mitral valve replacement (MVR) with the glutaraldehyde-preserved porcine Hancock bioprosthesis from March, 1970, through December, 1981. There were 312 female and 164 male patients ranging in age at operation from 9 to 68 years (average, 53 years). Associated surgical procedures were performed in 35 patients. Hospital mortality was 13%, the main cause of death being low-output syndrome. The survivors were followed from 1.6 to 13.2 years (mean, 5.2 years). Cumulative duration of follow-up is 2,180 patient-years and is 97% complete. Overall late mortality is 3.1 +/- 0.3% per patient-year, and actuarial survival is 73.8 +/- 3.4% at 13 years. Embolic accidents occurred in 45 patients and were fatal in 13; the linearized incidence of postoperative systemic thromboemboli is 2.1 +/- 0.3% per patient-year. Reoperation was necessary in 49 patients: in 4 because of valve endocarditis, with 3 deaths; in 6 because of perivalvular leak, with no deaths; in 2 because of left atrial thrombosis; and in 37 because of valve dysfunction due to primary tissue failure, caused mainly by calcific degeneration of the tissue, with 5 operative deaths. Actuarial freedom from primary tissue failure is 58 +/- 6.6% at 13 years. Extended follow-up after MVR with the Hancock bioprosthesis confirms the satisfactory performance and low thrombogenicity of this device up to 13 years after operation.(ABSTRACT TRUNCATED AT 250 WORDS)
The possible determinants of a fatal outcome following surgical repair of the tetralogy of Fallot were analyzed by postmortem examination in 14 cases. Only one patient died late in the postoperative period, due to patch detachment; the others died shortly after undergoing surgery. Death could not be explained in three cases. In three patients with perimembranous ventricular septal defects, complete atrioventricular block occurred as a consequence of traumatic disruption of the branching bundle. In four cases residual stenosis of the pulmonary outflow tract was shown; in one of these cases adequate relief of obstruction had been prevented by a large conal coronary artery. A residual mitral cleft was found in one patient. Death was not related to the cardiac conditions in two cases; one of these patients died of brain apoplexy and the other of tracheal hemorrhage. These findings stress the need for accurate preoperative diagnosis and precise knowledge of the surgical anatomy of this malformation.
Glutaraldehyde-tanned autogenous pericardium was compared with untreated autogenous pericardium as a tissue for replacement of anterior chordae tendinae of the mitral valve. Tanned autogenous pericardial chordae have a marked fibrous reaction at their healing ends but retain central pliability. Untreated autogenous pericardial chordae become uniformly fibrosed and stiff. Both retain their length, heal well to the papillary muscle and cusp, and are considered as potentially useful chordal substitutes in the right circumstances. Some of the response of the host to implanted tanned xenograft tissue must be related to the consequences of tanning rather than a reaction to foreign tissue.
From January 1968 to July 1983, 38 patients with an intracardiac myxoma underwent surgical excision of the tumor at our Institution. There were 15 males and 23 females, ranging in age from 17 to 68 years (mean 47.7). In all but 2 patients, the presence of an intracardiac myxoma was documented preoperatively by angiographic and/or echocardiographic study. The first 2 patients of this series were referred with the diagnosis of mitral stenosis, and the myxoma was an unexpected surgical finding. In 32 cases (84.2%) the myxoma was located in the left atrium, in 4 (10.5%) in the right atrium and in 2 (5.3%) in the right ventricle. Surgery was performed on an emergency basis in 36 patients. Two patients (5.2%) both with a left atrial myxoma, died after surgery: one died intraoperatively of hemorrhage and the other after one month of bowel infarction. Follow-up of the 36 survivors ranges from 3 months to 14.5 years (average 5.2 yr); all were controlled by means of clinical and echocardiographic investigations, and no evidence of tumor recurrence was detected. Surgery for intracardiac myxoma, which should be undertaken on an emergency basis, carries a low operative risk; excision of the tumor appears to be curative with no recurrences at long-term follow-up; non-invasive tools are of the utmost importance in both the preoperative assessment and follow-up of these patients.
The haemodynamic characteristics and durability of mitral bioprostheses were evaluated and compared in vitro in a pulse duplicator and in a fatigue test system. Porcine xenografts were shown to be the most stenotic of all bioprostheses, studied at rates simulating both rest and exercise; on the other hand the new generation of biological valves showed a clear improvement in haemodynamics compared with the standard porcine and pericardial prostheses so far used clinically. Durability tests performed at a rate of 1600 to 1800 beats per minute and with a closing pressure ranging from 80 to 100 mmHg showed that the Ionescu-Shiley and Edwards pericardial xenografts last significantly longer than the Hancock and Carpentier Edwards porcine valves and Hancock pericardial bioprosthesis. Correlation between the mode of failure of pericardial and porcine valves in vitro and in vivo clearly demonstrates that a major role in valve failure is played by mechanical stress. This can be either a consequence of the continuous trauma sustained by the tissue hitting against the bare dacron cloth of the sewing ring during the movements of the cusps. or a result of fatigue occurring and the bending points of the leaflets. The results of this study underline the importance of a continued in vitro evaluation of both haemodynamics and durability of bioprostheses, since some of the pericardial valves which had the best haemodynamic performance showed the worst resistance to fatigue-induced failure. A careful selection of the tissue, modification of the stent design and avoidance of a dacron covered frame are suggested to improve long-term durability of biological prostheses.
In a group of 40 patients discharged from the hospital after mitral valve replacement with an Ionescu-Shiley pericardial xenograft from January, 1977, to December, 1980, seven instances of valve failure occurred. This unprecedented incidence of bioprosthetic dysfunction after mitral valve replacement with the Ionescu-Shiley pericardial xenograft led us to update the follow-up of our patients receiving this valve in the mitral position. The results of our survey showed, at 6 years postoperatively, an actuarial survival rate of 72%, an actuarial probability of being free from emboli of 62%, and an actuarial freedom from prosthetic failure of 60%. The explanted valves showed complete absence of the neoendothelial lining of the Dacron-covered frame and lesions resembling those observed in Ionescu-Shiley pericardial xenografts removed from our fatigue test system after a mean of 29 +/- 17 X 10(6) cycles. This similarity prompted a classification of tears occurring in the mitral Ionescu-Shiley pericardial xenograft, which is of extreme importance, since the clinical presentation and outcome of patients with a failing valve differs according to the type of rupture. The lesions of the cusp observed in clinical specimens were possibly related to the continuous trauma of the tissue against the bare Dacron cloth during closure of the valve. It is concluded that (1) actual durability and thrombogenicity of the Ionescu-Shiley pericardial xenograft in the mitral position needs to be carefully reassessed, (2) close follow-up of such patients by clinical and two-dimensional echocardiographic evaluation is advisable after the third postoperative year, and (3) failure of the mitral Ionescu-Shiley pericardial xenograft may occur suddenly, and awareness of this complication is the clue to prompt recognition and treatment of such patients.
In a series of 23 dogs, glutaraldehyde-fixed xenograft pericardium was implanted as a left atrial wall patch (Group I, 11 dogs), as a substitute for the mitral valve chordae (Group II, 12 dogs), and as an external pericardial patch (Group III, five dogs, in which one of the two former procedures was associated). All dogs of Group I survived and were put to death after 12 months. The atrial patch appeared thickened and shrunken in all, with intense fibrous reaction, calcification, and even bone formation. The structural changes were minimal in the external aspect of the patch, not in contact with the host's endocardium and blood. Eight dogs of Group II survived from 7 months to 3 years. In all, the pericardial chordae were thickened and calcified with good healing at the suture lines; that their original length was retained, however, allowed for good valve function. In the dogs of Group III the pericardial substitute appeared well preserved after 12 months, not calcified, and without noteworthy degenerative changes. Minimal or absent epicardial adhesions were noted. We conclude that (1) the tendency for xenograft pericardial tissue to calcify is strongly influenced by the site of implantation and function and by contact with host blood and endocardium; (2) heterologous pericardium may be considered suitable for closure of pericardial defects after open cardiac operations, and (3) studies on calcification of biological tissue should be carried out by long-term evaluation of such tissues inside the heart.
Four patients had signs of primary bioprosthetic dysfunction within the fourth postoperative year after mitral valve replacement with an Ionescu-Shiley pericardial xenograft; they represent approximately 9% of patients with Ionescu-Shiley pericardial xenograft mitral valves followed up for more than 3 years at our institution. Pathological investigation showed severe incompetence of all explanted valves due to cusp tears and lacerations. Histologic study of the pericardial tissue disclosed mild to moderate collagen degeneration, without infection or calcification. Neoendothelial formation on the Dacron cloth of the sewing ring was either absent or minimal. The high incidence of valvular incompetence prompted us to try to establish a correlation between the in vivo and in vitro modes of failure of the Ionescu-Shiley pericardial xenograft. For this purpose, 10 unimplanted Ionescu-Shiley pericardial xenograft valves were tested in a fatigue test system. Severe fatigue-induced lesions occurred in this group after an average of 29.09 +/- 17.26 X 10(6) cycles; initial failure could be recognized in six of them after an average of 16.94 +/- 20.12 X 10(6) cycles. Valves tested in the fatigue test system showed tears and lacerations similar to those noted in the Ionescu-Shiley pericardial xenografts obtained from the four patients (which were assumed to have functioned for more than 100 X 10(6) cycles in each case). Correlation between results of the fatigue testing and our clinical experience enabled us to recognize four types of tears which may occur in the Ionescu-Shiley pericardial xenograft. The results of this investigation showed the following: (1) Primary tissue failure of the Ionescu-Shiley pericardial xenograft may occur suddenly. (2) A classification of tears occurring in Ionescu-Shiley pericardial xenograft valves is useful since the clinical presentation of patients may differ according to type and location of the lesion. (3) In the manufacture of pericardial valves, particular care must be observed in selection of the tissue and in the frame design. (4) Improvement of the quality control is one of the clues to enhance durability of the Ionescu-Shiley pericardial xenograft.
Five patients, who developed sternal wound infection following open heart surgery and in whom the standard methods of management of this complication had been unsuccessful, were treated with an autogenous vaccine. Complete healing of the sternal wound was obtained in 4 of them, while in one, who had an associated mediastinitis, a slow recovery with persistence of a sternal fistula occurred. The results of this preliminary experience indicate that the use of an autogenous vaccine might be regarded as an alternative method of treatment of sternal infections in selected patients.
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Among 61 heart specimens of tetralogy of Fallot with or without pulmonary atresia, four presented with an accessory tricuspid valve leaflet. This structure caused partial or almost complete obstruction of the ventricular septal defect. Depending on the morphology, the accessory tissue was classified into "mobile" or "fixed" types. The "mobile" variety was tethered by long chordae tendineae which permitted a wide excursion of the leaflet through the ventricular septal defect into the left ventricular outflow tract where it represented a potential cause of obstruction. The "fixed" variety was attached to the edges of the defect by short chordae which reduced considerably its movements. This type created a fixed obstruction of the ventricular septal defect without involving the subaortic left ventricular outflow tract. The precise morphology of the accessory tricuspid valve tissue is of considerable surgical significance. When mobile, the tissue must be resected at the time of surgical repair. When fixed it can be used as a suture anchorage during closure of the ventricular septal defect.