Mitral valve replacement with the St. Jude Medical prosthesis: a 15-year follow-up

BACKGROUND: A retrospective study was conducted to analyze the results of St. Jude Medical mitral valve replacement. METHODS: From January 1979 to December 1989, 870 patients (54% women, 46% men; mean age, 55.8 +/- 6.2 years) underwent mitral valve replacement with the St. Jude Medical prosthesis. Of these operations 616 were isolated mitral valve replacements and 254 were double valve replacements. Coronary artery bypass grafting was performed concomitantly in 55 patients (6.3%). RESULTS: Overall, early mortality was 5.05%, with 4.2% for the isolated mitral valve procedure and 7.08% for the double valve replacement. Follow-up at 15 years was complete in 859 patients (98.74%). Mean follow-up time was 93.5 months, for a total of 6,436 years. Actuarial survival at 15 years was 59.5% +/- 5%, 60.5% +/- 6%, and 56.9% +/- 9%, for the entire group, the isolated mitral valve and double valve procedures, respectively. Multivariate analysis identified age, sex, hospital stay, and preoperative mitral regurgitation as independent prognosis factors for overall mortality. Of 606 patients alive at the latest follow-up, the New York Heart Association class improved significantly (from 67% class III/IV before the operation to 88% class I/II after the operation). All patients received warfarin to maintain an international normalized ratio between 3.5 and 4. The linearized rates (% per patient-year) of thrombosis, thromboembolism, and major hemorrhage were, respectively, 0.21, 0.75, and 0.94 for the entire group; 0.18, 0.67, and 0.88 for the isolated mitral valve operation; and 0.15, 0.92, and 1.08 for the double valve replacement. For the entire group the freedom from thrombosis and thromboembolism at 15 years was 98.1% +/- 1% and 88% +/- 4%, respectively. No case of structural dysfunction occurred. The freedom from paravalvular leak and endocarditis at 15 years was 95.3% +/- 2% and 97.3% +/- 2.4%, respectively. The probability of remaining free from reoperation at 15 years was therefore 95.6% +/- 2.5%. CONCLUSIONS: These results confirm that the St. Jude Medical valve is a reliable prosthesis with very low thrombosis and thromboembolism rates, allowing the use of a low dose of anticoagulation with an international normalized ratio of about 3.     

Combined warfarin and antiplatelet therapy after St. Jude Medical valve replacement for mitral valve disease

OBJECTIVES: The clinical effect of combined warfarin and antiplatelet therapy on the incidence of stroke and postoperative complications after mitral (plus aortic) valve replacement was studied and compared with that observed with warfarin therapy alone. BACKGROUND: It has been reported that combined warfarin and antiplatelet therapy may be effective but may be associated with an increased hemorrhagic risk. Therefore, definite benefits of the treatment in patients with an implanted prosthetic valve have not been clearly documented. METHODS: Between January 1980 and December 1992, 195 patients with a St. Jude Medical valve at the mitral (plus aortic) position were assigned to receive treatment with either warfarin alone (125 patients) or warfarin plus antiplatelet agents (70 patients), such as dipyridamole (150 or 300 mg daily, 14 patients) or ticlopidine (200 or 400 mg daily, 56 patients). A minimal dose of aspirin (10 to 40 mg) was added (29 patients) if the maximal platelet aggregation rate by collagen was not reduced. The target thrombotest level was 10% to 20%. RESULTS: The two treatment groups were similar with regard to gender and age distribution. The number of patients with atrial fibrillation, left atrial thrombus, history of previous stroke, simultaneous aortic valve operation and previously performed valve procedures were comparable in the two groups. Actuarial survival rate at 10 years was 98.3 +/- 1.7% (mean +/- SD) in the warfarin plus antiplatelet group and 90.3 +/- 3.2% in the warfarin group (p < 0.05 at 1 and 9 to 12 years). The actuarial stroke-free rate at 10 years was 95.3 +/- 3.4% and 84.3 +/- 3.8%, respectively (p < 0.05 by the generalized Wilcoxon test). The actuarial complication-free rate at 10 years was 89.4 +/- 4.3% and 67.9 +/- 4.8%, respectively (p < 0.05 by the generalized Wilcoxon test). No hemorrhagic complications were seen in the warfarin plus antiplatelet group. CONCLUSIONS: The results strongly indicate the effectiveness and safety of combined warfarin plus antiplatelet treatment after St. Jude Medical valve replacement for mitral (plus aortic) valve disease.     

Impact of size mismatch and left ventricular function on performance of the St. Jude disc valve after aortic valve replacement

BACKGROUND: The hemodynamic function of the St. Jude valve may change relative to changes in left ventricular function after aortic valve replacement for aortic stenosis. From theoretical reasons one may hypothesize that prosthetic valve hemodynamic function is related to left ventricular failure and mismatch between valve size and patient/ventricular chamber size. METHODS: Forty patients aged 24 to 82 years who survived aortic valve replacement for aortic stenosis with a standard St. Jude disc valve (mean size, 23.5 mm; range, 19 to 29 mm) were followed up prospectively with Doppler echocardiography and radionuclide left ventriculography preoperatively and 9 days, 3 months, and 18 months after the operation with assessment of intravascular hemolysis at 18 months. Follow-up to a maximum of 7.4 years (mean, 6.3 years) was 100% complete. RESULTS: Left ventricular muscle mass index decreased from 198 +/- 62 g.m-2 preoperatively to 153 +/- 53 g.m-2 at 18 months (p < 0.001), paralleled by a significant increase in left ventricular ejection fraction, peak ejection rate, and peak filling rate; only 18% of the patients had normal left ventricular muscle mass index and only 32% normal ventricular function (normal left ventricular ejection fraction, peak ejection rate, peak filling rate, early filling fraction, and late filling fraction during atrial contraction) at 18 months. Prosthetic valve peak Doppler gradient dropped from 20 +/- 6 mm Hg at 9 days to 17 +/- 5 mm Hg at 18 months (p < 0.05). Reduction of left ventricular muscle mass index was unrelated to peak gradient and size of the valve. Peak gradient at 18 months rose with valve orifice diameter of 17 mm or less (by 6 mm Hg), orifice diameter/body surface area of 9 mm.m-2 or less (by 5 mm Hg), left ventricular enddiastolic dimension (by 23 mm Hg per 10 mm increase), and impaired ventricular function (by 3 mm Hg). All but 2 patients (5%) had intravascular hemolysis; none had anemia. Two patients with moderate paravalvular leak had the highest serum lactic dehydrogenase levels; 4 patients with trivial leak had higher serum lactic dehydrogenase levels than those without leak. Serum lactic dehydrogenase levels rose with moderate paravalvular leak, impaired ventricular function, and valve orifice diameter. Six patients with trivial or moderate paravalvular leak had a cumulative 7-year freedom from bleeding and thromboembolism of 44% +/- 22% compared with 87% +/- 5% for those without leak (p < 0.05). CONCLUSIONS: The peak gradient of the St. Jude aortic valve dropped marginally over the first 18 postoperative months in association with incomplete left ventricular hypertrophy regression and marginal improvement of ventricular function. Mismatch between valve size and ventricular cavity size or patient size and impaired function of a dilated ventricle significantly compromised the performance of the St. Jude valve. Probably explained by platelet destruction or activation, paravalvular leak was related to bleeding and thromboembolic complications.     

St. Jude Medical valve prosthesis: an analysis of long-term outcome and prognostic factors

Between 1979 and 1984, 321 patients received 354 St. Jude Medical prostheses (194 aortic, 94 mitral, 1 tricuspid, and 32 multiple valve replacements). Follow-up was 96% complete (2967 patient-years; mean 9.5 years per patient). Actuarial event-free rates at 10 years and linearized rates (in parentheses) of late complications were as follows: embolism, 85.0% +/- 2.3% (2.3% per patient-year); anticoagulant-related hemorrhage, 74.8% +/- 2.7% (3.3% per patient-year); cerebrovascular accident, 81.8% +/- 2.5% (2.6% per patient-year); prosthesis thrombosis, 98.5% +/- 0.7% (0.1% per patient-year); endocarditis, 97.2% +/- 1.1% (0.4% per patient-year); prosthesis dysfunction, 97.1% +/- 1.0% (0.4% per patient-year); hemolytic anemia, 98.5% +/- 0.7% (0.1% per patient-year); reoperation, 97.4% +/- 1.0% (0.4% per patient-year); overall mortality, 63.3% +/- 2.7% (4.2% per patient-year); and valve-related death (including sudden death), 84.7% +/- 2.2% (1.4% per patient-year). Independent preoperative risk factors were as follows: (1) for embolism, cardiac failure as indication for operation and history of prior systemic embolism; (2) for cerebrovascular accidents, the same two factors and age; (3) for endocarditis, diabetes, chronic alcoholism, and aortic valve replacement; (4) for overall mortality, age, ejection fraction (or cardiac index or cardiothoracic index), chronic alcoholism, and history of systemic embolism; and (5) for valve-related death, chronic alcoholism, degenerative cause of valve disease, and prosthetic diameter 23 mm or smaller. Ninety percent of survivors were in New York Heart Association functional class I or II at the end of follow-up. In conclusion, this study confirms the excellent durability of the St. Jude Medical valve and the remarkable functional benefit for the majority of the patients. However, prosthesis-related complications are still common, particularly for small-diameter prostheses. Outcome is strongly related to the patient's preoperative cardiac condition and to the adequacy of anticoagulation control.     

Mitral valve repair vs replacement. Current recommendations and long-term results

Techniques now exist to correct abnormalities of all components of the mitral valvular apparatus except extensive loss of pliable leaflet area. Thus, paradoxically, myxomatous valves with redundant leaflets represent the ideal candidates for mitral valve repair. Repair for mitral insufficiency can be performed for some rheumatic valves, but patient selection is critical. Loss of leaflet area, leaflet thickening, and extensive calcification of the leaflets or commissures are contraindications to repair. The abnormalities of the subvalvular apparatus are less important because a complete set of new chordae can be reconstructed using PTFE suture material. Some cases of endocarditis are ideal for repair using localized débridement and pericardial patch repair with or without PTFE chordal replacement. True ischemic mitral regurgitation of the Carpentier type I category is still something of a surgical enigma. Because it is a restrictive leaflet motion problem, annuloplasty alone is not always effective, and the outcome of any given repair attempt is less predictable. Repairs in patients with small annuli and multiple leaflet defects requiring complex series of maneuvers have a low probability of success. Furthermore, such patients with small left ventricular cavities are more prone to experience SAM. Several factors contributing to which therapy is chosen for mitral valve disease are summarized in Table 1. Patient selection, accurate evaluation of the cause or causes of mitral regurgitation, and well-executed application of the appropriate techniques for repair are all critical factors in the early and late success of mitral valve repair.     

Mitral valve replacement with total preservation of native valve and subvalvular apparatus

BACKGROUND AND AIMS OF THE STUDY: Preservation of the mitral valve and subvalvular apparatus was introduced clinically in the early 1960s, but for two decades the technique for mitral valve replacement included excision of both leaflets and their attached chordae tendineae. Lately, emphasis has been replaced on retaining the mitral subvalvular apparatus during valve replacement because of its role in left ventricular function. Hence, during the past six years, when performing mitral valve replacement we have, when possible, preserved the valvular and sub-valvular mitral apparatus. METHODS: Between January 1990 and November 1996, complete retention of all mitral tissue in connection with mitral valve replacement was performed in 58 patients (23 women and 35 men). Mean age was 63 years (range: 23 years to 77 years). Coronary bypass was a concomitant procedure in 19 patients; both the mitral and aortic valve was replaced in four cases. Calcified and/or stenotic valves were not a contraindication for the procedure; calcified plaques were removed. Adhesion between anterior and posterior leaflets was treated with sharp dissection. Valve and subvalvular tissue were preserved. The leaflets were reefed within the valve-sutures and compressed between the sewing ring and the native annulus when implanting the valve prosthesis. Chordal tension on the ventricle is thus maintained and the chordae pulled away from the valve effluent. RESULTS: Six patients died in the postoperative period and three had transient neurological symptoms. In no patient was death or transient neurological symptoms a consequence of the retention of mitral leaflets with subvalvular apparatus. CONCLUSIONS: We find the described technique to be useful not only in valve insufficiency but also in valve stenosis when preserving the mitral leaflets with sub-valvular apparatus during valve replacement. The technique is without procedure-related complications and prevents obstruction of left ventricular outflow tract.     

Entrapment of leaflet of St. Jude medical cardiac valve prosthesis by miniscule thrombus: report of two cases

Two patients with dysfunction of the St. Jude Medical cardiac valve prosthesis, one in the aortic and one in the mitral position, are presented. In both, one of the valve leaflets was jammed by a very small thrombus that fixed the leaflet in a semiclosed position. Neither patient received anticoagulation postoperatively. Because of the pathological findings in these 2 patients, anticoagulation for patients with a St. Jude Medical valve prosthesis is recommended for life.     

Application of color Doppler flow mapping to calculate orifice area of St Jude mitral valve

BACKGROUND: The effective orifice area (EOA) of a prosthetic valve is superior to transvalvular gradients as a measure of valve function, but measurement of mitral prosthesis EOA has not been reliable. METHODS AND RESULTS: In vitro flow across St Jude valves was calculated by hemispheric proximal isovelocity surface area (PISA) and segment-of-spheroid (SOS) methods. For steady and pulsatile conditions, PISA and SOS flows correlated with true flow, but SOS and not PISA underestimated flow. These principles were then used intraoperatively to calculate cardiac output and EOA of newly implanted St Jude mitral valves in 36 patients. Cardiac output by PISA agreed closely with thermodilution (r=0.91, Delta=-0.05+/-0.55 L/min), but SOS underestimated it (r=0.82, Delta=-1.33+/-0.73 L/min). Doppler EOAs correlated with Gorlin equation estimates (r=0.75 for PISA and r=0.68 for SOS, P<0.001) but were smaller than corresponding in vitro EOA estimates. CONCLUSIONS: Proximal flow convergence methods can calculate forward flow and estimate EOA of St Jude mitral valves, which may improve noninvasive assessment of prosthetic mitral valve obstruction.     

Asynchronous bilateral retinoblastoma: the St. Jude Children's Research Hospital experience

Between May 1962 and July 1993, 172 children presented at the St. Jude Children's Research Hospital for evaluation and/or treatment of retinoblastoma (RB). Of these, 65 presented with bilateral disease, while 107 had unilateral tumors. Of these 107 patients, nine subsequently developed RB in the unaffected eye. Initial age at diagnosis of these nine patients ranged from 3 weeks to 24 months (median = 2 months); five of the nine had a family history of RB at the time of initial diagnosis and one patient, without a family history of RB, presented with unilateral multiple tumors indicating inheritance of a germinal mutation and increased risk of RB development in the companion eye. Time to development of companion eye RB was 1-61 months postinitial diagnosis. Treatment of the initial eye included enucleation (n = 4), chemotherapy (n = 3), irradiation (n = 7), or a combination of these three modalities. Reese-Ellsworth grouping of the companion eye disease included I A (n = 7), III A (n = 1), and IV A (n = 1). Treatment of the second affected eye included irradiation in seven patients, cryotherapy in four, and chemotherapy in three. No companion eye has required enucleation to date. At last followup, 14/18 eyes remain intact. There have been no cases of metastatic dissemination; however, one patient has developed a second malignant neoplasm outside the field of irradiation. Eight of the nine patients remain alive. This experience reinforces the need for close follow-up of patients diagnosed with unilateral RB, especially those with a family history of RB and those with unilateral multiple tumors.     

Results of heart valve replacement: especially on the selection criteria for valve prostheses and on a new anticoagulation regimen

Since March 1981 till the end of 1987, a total of 76 artificial heart valves were implanted in 72 patients. Heart valve prostheses were selected individually according to the patient's needs rather than assigning a single model to every patient. Postoperatively patients were placed on an anticoagulation therapy regimen consisting of reduced-dose warfarin (prothrombin time maintained at 30% of the control) and a small dose (81 mg/day) aspirin. During this period no bioprosthesis was implanted. For aortic valves, Starr-Edwards caged-ball valves were used in 53.1% and St. Jude Medical (SJM) valves in 37.5%. For mitral valves, SJM valves were used in 68%. No mechanical valve failure and no thrombosed valve was encountered. There was one patient-prosthesis missmatch. The incidence of thromboembolism for the entire series was 5/181.2 patient-years. There was 1-2/181.2 patient-years incidence of hemorrhagic complications. These figures were comparable to the ones with conventional warfarin therapy. No intracranial hemorrhage was encountered. Our selection criteria for artificial heart valves and our method of anticoagulation were discussed in detail. We conclude that at present there is no single prosthesis which satisfies all the varying needs of every patient, and the prosthesis which is best suited to that particular patient should be selected. We are generally happy with our current method of postoperative anticoagulation and will continue with this regimen.     

The St. Jude biopolymeric graft in reconstruction of peripheral arteries

The authors present their preliminary results of St. Jude Bio Polymeric graft application in the periphery arteries reconstruction. This biograft like all the previous ones (Soleo, CB.S., human umbilical veins) was introduced with the aim of creating a better substitute for autovenous Graft, which has been irreplacible ever before, especially in cases of crural reconstruction. The operated patients were classified into the II stadium of occlusive disease (claudication) and indications for surgery have been based on Doppler sonography and arteriography. In three cases crural femoro-popliteal reconstruction was carried out, because of an occlusion of the superficial femoral artery, in one case a femoro-femoro cross over bypass due to an occlusion of the iliac artery. Postoperative follow-up ranged from 6 to 12 months and the control of the graft passage by. Doppler sonography and arteriography confirmed patency of all grafts. I.e. the preliminary results are excellent.     

Mitral valve prolapse. Recent concepts and observations

The conditions associated with prolapse of the posterior leaflet of the mitral valve are multiple. The mechanisms of mitral valve prolapse as well as the pathogenesis of pain and ectopic impulse formation are reviewed. Propranolol appears to be the drug of choice for the symptomatic treatment of patients with this syndrome since it decreases myocardial oxygen demand and wall tension thus reducing or abolishing the discrepancy between myocardial oxygen demand and supply within the mitral apparatus. It has also been reported to modify the auscultatory findings associated with this condition. The frequency of this mitral valve abnormality in patients with obstructive coronary artery disease is reviewed. It appears that prolapse of the posterior leaflet scallops in patients with significant obstructive coronary artery disease represents an intermediate stage before mitral insufficiency occurs. This group of patients with papillary muscle dysfunction includes those with prolapsed leaflets without mitral insufficiency, those with systolic murmurs and compensated heart failure and others with progressive cardiac decompensation and severe mitral regurgitation.     

Mitral valve replacement and coronary artery bypass grafting for postinfarction mitral papillary muscle rupture

A 79-year-old man was admitted to our hospital with heart failure following acute inferior myocardial infarction. An echocardiogram demonstrated severe mitral insufficiency, and coronary arteriography revealed double vesel disease. Following diagnosis of ischemic papillary muscle dysfunction, PTCA was performed, but the mitral insufficiency was not eliminated. Follow-up echocardiography disclosed rupture of the posterior papillary muscle. He underwent surgery on the 30th day after onset of acute myocardial infarction. Partial rupture of the posterior papillary muscle was found at surgery, and mitral valve replacement and single coronary artery bypass to Lcx were performed. His postoperative course was uneventful, and he was discharged on the 46th day after operation.     

Malignant peripheral nerve sheath tumors: the St. Jude Children's Research Hospital experience

BACKGROUND: Malignant peripheral nerve sheath tumors (MPNSTs) are uncommon in young patients. To contribute to the understanding of these tumors, we reviewed the records of all patients treated for PNSTs at one institution over a 30-year period. METHODS: We reviewed the records of eight patients treated for benign PNSTs and 28 patients treated for 29 MPNSTs. We focused on the latter group, statistically testing several clinical factors for their significance in affecting survival. RESULTS: Five-year survival in patients with MPNSTs was 39%. The most significant prognostic factor was gross tumor resectability (p = 0.0004). Five-year survival for patients with resectable tumors was 65%, whereas no patient with unresectable disease survived > 25 months. Tumor grade, site, and patient race were also significant factors by univariate analysis but were not significant when adjusted for resectability. CONCLUSION: Gross tumor resection is crucial in treating malignant PNSTs. Supplemental radiation therapy is recommended for positive microscopic margins. More effective treatment is still being sought for unresectable disease.     

Advance in mitral valve repair using a device flexible in three dimensions. The St Jude Medical-Séguin annuloplasty ring

To allow remodeling of the annulus while respecting natural three dimensional annular movements during mitral valve repair, a new annuloplasty ring (St Jude Medical [SJM]-Séguin annuloplasty ring) was developed. This ring has variable flexibility; that is, it is sufficiently rigid on the anterior portion to maintain intercommissural distance, and sufficiently flexible on the posterior portion to respect left ventricular function and natural three dimensional annular mobility. Fifty patients operated on for pure mitral regurgitation between January, 1994 and June, 1995 were studied. Mean age was 58 years. The cause of mitral insufficiency was degenerative in 80% of the patients, rheumatic in 12%, ischemic in 4%, and infectious in 4%. The operative technique to restore normal valve coaptation was quadrangular resection in 31 cases, commissurotomy and chordal fenestration in 8, use of polytetrafluoroethylene chordae in 6, and chordal shortening or transposition in 5. Annuloplasty with a SJM-Séguin annuloplasty ring was realized in all 50 cases. Transesophageal echocardiographic mitral regurgitation decreased from 3.6 +/- 0.8 to 0.3 +/- 0.2 after repair (p < 0.005). Two post operative deaths due to non valve related complications, were observed. There were no ring related complications, especially no left ventricular outflow tract obstruction due to systolic anterior motion. Patients were all reviewed at a mean follow-up of 12.1 months (range, 9-27 months). All are well, in New York Heart Association functional Class I. Echocardiography showed a mean 0.4 +/- 0.3 mitral regurgitation, absence of any systolic anterior motion, and satisfactory mobility of the annuloplasty ring after the movements of the natural annulus, including non planar deviation. These preliminary results suggest that this annuloplasty ring 1) provides excellent correction of annular dilatation and remodeling of the annulus, 2) avoids systolic anterior motion observed with rigid rings, and 3) preserves physiologic three dimensional annulus motion.     

Hemodynamic evaluation of the Carbomedics R, St Jude Medical HP and Sorin-Bicarbon valve in patients with small aortic annulus

A Doppler echocardiographic study was performed to evaluate the hemodynamic performance of three 19 mm size currently used bileaflet valve prosthesis (St Jude Medical Hydrodinamic Plus, Sorin-Bicarbon and Carbomedic Reduced) implanted in aortic position. METHODS: Patients, 30, with the same profile receiving 19 mm size valve (ten for each valve type) were selected when body surface area (BSA) was > 1.7 m2. Doppler echocardiography was carried out at rest and after exercise, 60 days after surgery. Peak (Pg) and mean (Mg) gradients across the valve were recorded: the effective orifice area (EOA), and performance index (PI) were calculated. RESULTS: No significant differences were observed between St Jude Medical and Sorin Bicarbon as far as peak and mean gradient, effective orifice area and performance index at rest and after exercise. A significant difference (P < 0.05) was demonstrated in the above mentioned parameters when Carbomedics-R valve were tested. This type of valve showed a lower EOA and PI with higher Pg and Mg gradient both at rest and after exercise. CONCLUSION: The St Jude Hydrodymanic plus (Hp) and Sorin Bicarbon valves had similar performance and a better hemodynamic trend when compared to the Carbomedics-R valve in patients with large body surface areas. The Carbomedics-R valve shows a ineffective use of the total area of the prosthesis both at rest and after exercise.     

Simplified method of evaluating dysfunction in St. Jude medical prosthetic heart valves

The St. Jude medical valve is one of the most common heart valve prostheses used. More than 450,000 have been implanted. Patients with these prosthetic valves need full anticoagulation and close follow-up for life. Without adequate oral anticoagulation, thrombotic complications may develop. A simple method of evaluating the full range of motion of the valve leaflets can be attained by fluoroscopy. Fluoroscopy is easily available, non-invasive, and diagnostic. This article demonstrates early recognition of valve dysfunction due to thrombosis with fluoroscopy leading to prompt treatment.     

Outcome analysis of 245 CarboMedics and St. Jude valves implanted at the same institution

BACKGROUND: Thromboembolism and valve-related death are major complications associated with prosthetic valve implants, but it is difficult to evaluate the relative incidence of these complications based on studies in which the implantation of only one valve is reported from any given institution. We therefore report the outcome of patients implanted at our institution during the same time period with either the recently released CarboMedics (CM) or the St. Jude Medical (SJ) valve prostheses. METHODS: Between October 1994 and January 1996, 245 consecutive patients received either SJ (116 patients) or CM (129 patients) valves at our institution. Follow up of these patients was 99.6% complete, for a total of 318.5 cumulative patient-years (median follow-up, 1.4 years). RESULTS: The 30-day mortality rates for SJ and CM implants were 3.4% and 3.1%, respectively. Actuarial survival and freedom from valve related mortality rates at 1.5 years for SJ and CM valves were 94%+/-2% versus 86%+/-3% (p = 0.03) and 100% versus 94%+/-2% (p = 0.005), respectively. There was no structural valve failure for either implant, but there were five thrombosed valves in the CM group and none in the SJ group (p = 0.04). All thrombosed valves were mitral (four mitral valve replacement, one aortic and mitral valve replacement). Two of the thrombosed valves were successfully explanted, whereas the three remaining patients died. Freedom from a thromboembolic event in the mitral position at 1.5 years, including thrombosed valves was 97%+/-3% and 83%+/-5% for SJ and CM valves, respectively (p = 0.04). CONCLUSIONS: The results of this study suggest that further evaluation of thromboembolic outcomes after CM compared with SJ valve implantation is warranted.     

Synovial sarcoma in children and adolescents: the St Jude Children's Research Hospital experience

PURPOSE AND METHODS: We reviewed the clinical records and pathologic findings of 37 children and adolescents with synovial sarcoma treated at our institution over a 30-year period to evaluate the prognostic significance of tumor size, invasiveness, histology, and other features. RESULTS: The 20 male and 17 female patients with synovial sarcoma had a median age of 13.7 years at diagnosis. Primary tumor sites were the extremities (n = 27), trunk (n = 8), and head and neck (n = 2). Disease stage (clinical group) was as follows: group I, n = 21; group II, n = 7; group III, n = 4; and group IV, n = 5. Nineteen patients had invasive (T2) lesions, 20 had tumors more than 5 cm in diameter, and 14 had histologic grade 3 lesions. The estimated 5-year survival rate (+/- SE) for patients with group I or II disease was 80% +/- 9%, compared with 17% +/- 15% for those with group III or IV tumors (P = .0003). An exact log-rank test, adjusted for clinical group, showed that tumor invasiveness and grade independently predicted overall and progression-free survival (P < .05); tumor size was significantly correlated with progression-free survival. A borderline significant relationship with overall survival was found for both tumor size and histologic subtype (P = .09). CONCLUSION: A controlled trial of adjuvant chemotherapy is merited in children with resected synovial sarcoma (clinical group I or II) who present with unfavorable clinicopathologic features such as large, invasive, or grade 3 lesions. Children with unresected or metastatic disease fare poorly despite multimodality therapy and require novel treatment approaches.