Biomedical subjects
Publications and source records attributed to E Vitali.
The use of Gore-Tex (W.L. Gore & Assoc, Flagstaff, AZ) sheet for pericardial closure in patients with left ventricular assist device as a bridge to transplant allows easy dissection of epicardial adhesions and safe resternotomy at the moment of heart transplantation, with no complications or significant cost increase related to the Gore-Tex itself.
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OBJECTIVE: Although the relationship between delayed 201Tl distribution and blood flow in acutely ischemic and infarcted myocardium has been widely explored in the experimental setting, its behaviour in chronically hypoperfused dysfunctioning human myocardium has not yet been evaluated. METHODS: In tissue samples of excised failing hearts taken from ischemic (IHD) patients and idiopathic dilated cardiomyopathy (IDC) controls, we evaluated the relationship between delayed 201Tl retention (4 h redistribution), blood flow (assessed by means of 99mTc-labelled human albumin microspheres injected during transplantation) and biochemically-assessed fibrosis. 201Tl activity was expressed as the percent of the activity in the region with highest flow and the least fibrosis. RESULTS: Fibrosis and 201Tl activity were inversely related (r = -0.62, P = 0.0001). In IDC controls, low flows corresponded to uniformly preserved 201Tl retention. In IHD, 46 segments with flows < or = 0.60 ml.min-1.g-1 and 20 segments with flows > 0.60 ml.min-1.g1 showed matching delayed 201Tl retention and flow values; in the remaining 27, there was a disproportionately high tracer accumulation in comparison with flow (flow/201Tl mismatch). Despite significantly less fibrosis and lower flows, the mismatch segments showed significantly greater. 201Tl activity than the segments with concordantly high tracer retention and flow values. Conversely, at equivalent flow rates, the mismatch regions had less fibrosis than the areas with concordantly depressed 201Tl activity and perfusion. CONCLUSIONS: This super-normal 201Tl retention in hibernating myocardium may indicate a mechanism of cell adaptation to chronic hypoperfusion.
BACKGROUND: After 13 years of transplant experience in our center, we analyzed the results in the overall population and in particular subgroups of heart transplant recipients. We tried to identify risk factors for both early (3 months) and late (over 3 months) mortality after heart transplantation. METHODS: The data on 461 patients transplanted from November 1985-June 1998 were reviewed. To study risk factors for mortality, the results for 313 patients operated on from June 1985-June 1995 were studied and analyzed with a multivariate logistic regression and Cox's proportional hazard model. Seventy pre-, intra- and postoperative variables were considered including patient demographics, clinical status, hemodynamic parameters, donor characteristics, donor-recipient HLA mismatches, complications, and immunosuppressive protocols. We also compared results for patients transplanted from 1985-1991 (Group 1) and from 1992-1998 (Group II) to assess improvements due to changes in indications and in perioperative treatments. RESULTS: Overall mortality in the entire population was 20.2% (93/461). The 30-day, 3-month and late mortality rates were 8.0%, 10.2%, 11.1%, respectively. Group II mortality rates were 6.5%, 8.5% and 6.8%, respectively, despite a significant increase in Status I patients (20.6% in Group I vs 49.0% in Group II, p = 0.0001). The main causes of death were graft failure (24.7%), cardiac allograft vasculopathy (18.3%), and infection (16.1%). The mean follow-up of the 414 recipients who survived more than 3 months was 54.0 +/- 37.3 months. Actuarial survival was 87.4%, 79.2% and 68.9% at one, 5 and 10 years, respectively. The difference in the 5-year actuarial survival rates between Group I and Group II patients was statistically significant (73.5% vs 83.9%, p = 0.0135). The transpulmonary gradient, right atrial pressure and mid-high doses of donor inotropic support were identified as independent risk factors for early mortality. The number of moderate rejections at biopsy and early posttransplant infections were identified as independent risk factors for late mortality. The results of patients transplanted while on ventricular assist devices, urgent and elective patients and combined heart and kidney transplants were also reported. CONCLUSIONS: The overall results of our 13-year experience are very satisfying in relation to early and late mortality, with a significant favorable trend between patients transplanted in the early era (1985-1991) and those transplanted in the recent era (1992-1998). Pulmonary hypertension and elevated preoperative right filling pressure appear to indicate a significantly increased risk of early death and only marginally influence late survival, which is principally influenced by severe postoperative complications. Good results were achieved in combined heart and kidney transplantation and among patients who deteriorated during the waiting period and were supported with ventricular assist devices. The early and late outcomes for urgent (status I) and elective (status II) heart transplant patients were comparable.
A 50-year-old man, who 9 months earlier had undergone emergency operation for acute type I aortic dissection, was readmitted to our hospital with the diagnosis of an enlarging aneurysm of the false lumen involving the transverse arch and the proximal third of the descending thoracic aorta, due principally to redissection at the distal suture line of the ascending aortic graft. Replacement of the aortic arch and proximal descending thoracic aorta was performed by using the retrograde "pull-through" technique with hypothermic circulatory arrest and retrograde cerebral perfusion. Although circulatory arrest lasted 110 minutes, the patient was extubated on the 2nd postoperative day and had no central or peripheral neurologic damage. Mild, transitory renal dysfunction was observed in the 1st postoperative week, and the patient was discharged on the 18th postoperative day. He is asymtomatic at 15 postoperative months. Deep hypothermia and retrograde cerebral perfusion proved effective despite prolonged circulatory arrest. The retrograde "pull-through" technique is an effective method of replacing the entire thoracic aorta and should probably be considered for single-stage repair of acute type I aortic dissection with multiple intimal tears.
BACKGROUND: At 10-years from beginning of transplant experience in our Center we analyzed the overall results in an attempt to identify risk factors for early (3 months) and late (over 3 months) mortality after heart transplantation (HTx). METHODS: The data of 313 patients transplanted from November 1985 to June 1995 were studied and analyzed with a multivariate logistic regression and Cox's proportional hazard model. Seventy pre, intra and postoperative variables were considered: demographics, clinical status, hemodynamic parameters, donor characteristics, donor-recipient mismatch, complications, immunosuppressive protocols. In this paper we compared results in patients operated on from 1985 to 1990 (Group I) and from 1991 to 1995 (Group II) in order to assess improvements due to changes in HTx indication and in perioperative treatments. RESULTS: Overall mortality in the entire group was 19.8% (62/313): 30-days, 3 months and late mortality rates were 8.0%, 10.2%, 10.7% respectively. In Group II mortality rates were 7.1%, 8.6% and 2.8% respectively despite significant increase in Status I patients (21.5% in Group I vs 40.1% in Group II, p = 0.0008). Main causes of early death were: graft failure (46.9%), infection (28.1%), acute- rejection (12.5%). Main causes of late death were: cardiac allograft vasculopathy (40.0%) and neoplasm (23.3%). The mean follow-up of the 281 survivors more than 3 months is 45.6 +/- 30.0 months (range 3 to 120 months). Actuarial survival is 86.9 +/- 1.9%, 78.4 +/- 2.7% and 70.7 +/- 3.9% at 1, 5 and 10 years respectively. The difference in the 5-years actuarial survival between Group I and Group II patients is statistically significant (70.7 +/- 4.2% vs 84.5 +/- 4.5%, p = 0.005). TPG (OR 1.19), RAP (OR 1.13) and MD-HD inotropic support of donor (OR 3.81) were identified as independent risk factors for early mortality. Number of moderate rejection at biopsy (OR 1.56) and early postTx infection (OR 3.37) were identified as independent risk factors for late mortality. CONCLUSIONS: The overall results of our ten-year experience are very satisfying in relation to early and late mortality, with a significant favourable trend between patients transplanted in the early era (1985-1990) and those transplanted in the recent era (1991-1995). The study confirm that morbidity and mortality have the highest incidence during the early post-transplantation phase. Pulmonary hypertension and elevated preoperative right filling pressure appear to indicate a significantly increased risk of early death and only marginally influence late survival that is principally related to the severe postoperative complications. Differently from other observations, among the donor-related and recipient-donor matching variables, this analysis evidenced as significant only the need for MD-HD catecolamines during donor-management.
OBJECTIVES: This study sought to compare the mitral valve areas of patients with rheumatic mitral valve stenoses as determined by means of four echocardiographic and Doppler methods with those obtained by direct anatomic measurements. BACKGROUND: There has been no systemic comparison between Doppler-determined valve areas and the true anatomic orifice in a single cohort. METHODS: In 30 patients with mitral stenosis, the mitral valve areas determined by two-dimensional echocardiographic planimetry, pressure half-time, flow convergence region and flow area were compared with the values directly measured on the corresponding excised specimen by means of a custom-built sizer. RESULTS: The correlation coefficient was r = 0.95 (SE 0.06, p < 0.0001) for two-dimensional planimetry; r = 0.80 (SE 0.09, p < 0.0001) for pressure half-time; r = 0.87 (SE 0.09, p < 0.0001) for flow convergence region; and r = 0.54 (SD 0.1, p < 0.002) for flow area. Two-dimensional echocardiographic planimetry, pressure half-time, flow convergence region and flow area overestimated the actual anatomic orifice by > 0.3 cm2 in 2, 1, 6 and 0 patients, respectively, and underestimated it by > 0.3 cm2 in 0, 4, 1 and 8 patients, respectively. CONCLUSIONS: Mitral valve areas determined by two-dimensional planimetry, pressure half-time and proximal flow convergence region reliably correlated with size of the anatomic orifice. The flow area method provided a less reliable correlation.
To identify the operating risks for mortality and morbidity in patients undergoing aortocoronary bypass surgery, the data of 514 myocardial revascularisation procedures performed consecutively between January 1991 and December 1992 were analysed; 73.2% of the patients had associated diseases and 59.3% had suffered one or more previous myocardial infarctions. The mean ejection fraction of the population as a whole was 52.2 +/- 13. In 10.5% of the cases there was severe left ventricular (LV) function impairment with a mean ejection fraction (EF) of 30.2 +/- 4.4 (range 20-35). A major preoperative complication occurred in 8.2% of the entire population and 68.8% of the patients undergoing emergency surgery. Surgery was elective in 72.7% of the cases, urgent in 15.4% and emergency in 11.9%. Hospital mortality was 4.1% (CL 3.2-4.9). In the group of electively operated patients, mortality was 2.7% (CL 1.8-3.5), with no statistically significant difference (P = 0.943) from the mortality observed in the patients undergoing urgent surgery [2.5% (CL 0.8-4.1)]. The mortality in both groups was statistically different (P = 0.0001 and P = 0.008) from that of the patients undergoing emergency surgery [14.7% (CL 10.1-18.9)]. Perioperative acute myocardial infarction occurred in 5.4% of the patients (CL 4.4-6.4), in three cases resulting in death [10.7% (CL 4.8-15.8)]. Fourteen of the acute myocardial infarctions (AMI) occurred in the 42 patients undergoing emergency surgery for acute coronary occlusion (33.3%). A percentage of 18.7% of the 493 surviving patients suffered a postoperative complication.(ABSTRACT TRUNCATED AT 250 WORDS)
Complications involving the ascending aorta after cardiac surgery are rare (< 1%). Clinical findings are aspecific and may present a long time after surgery. Diagnostic imaging is used to show the type of complication and to provide adequate information for a suitable therapy. The authors investigated both efficacy and usefulness of MRI in the study of cardiac surgery complications involving the ascending aorta. Ten patients treated for heart disease were examined with MRI. Eight of them had had aortic valve replacement, 1 ascending aorta replacement and 1 both. Chest radiography and MRI were performed in every patient; 4 patients underwent transthoracic echocardiography (TTE) and transesophageal echocardiography (TEE), 2 patients TTE and 1 TEE; 2 patients were submitted to CT and 4 to angiography. MRI showed 3 ascending aorta aneurysms, 3 dissecting aneurysms and 4 pseudoaneurysms. In the patients with aneurysms and dissecting aneurysms, MRI correctly demonstrated both the aneurysm and the intimal flap. MRI showed only large pseudoaneurysms, depicting mediastinal hemorrhage suggestive of pseudoaneurysm if the latter was small. In such cases, only angiography showed the breach site. In conclusion, MRI can be considered the method of choice to depict cardiac surgery complications involving the ascending aorta if aneurysms and dissecting aneurysms are present, because it yields enough information for both diagnosis and surgery. In contrast, in pseudoaneurysms or mediastinal hematomas angiography is necessary to show the exact rupture site of the aortic wall.
From January 1982 to December 1991, 65 interventions were performed in 61 patients with active infective endocarditis (IE): 32 on native valves (Group 1) and 33 on prosthetic valves (Group 2). In Group 1, 23 patients had a known previous valve disease; major preoperative clinical complications occurred in 16 patients (50%); 84% were in NYHA classes III and IV. In Group 2 major preoperative clinical complications occurred in 13 patients (44.8%); 86% were in NYHA classes III and IV. The mean time interval between the onset of hemodynamic impairment of varying degrees and surgery was 13 +/- 15 days for Group 1, and 8 +/- 11 days for Group 2. In all cases, the native valves or prostheses were replaced by mechanical valve prostheses. Particular procedures were performed in three patients in Group 1 and five patients in Group 2. In Group 1 there were 8 hospital deaths (25%) and 11 (34.4%) non-fatal complications. In Group 2 there were 9 deaths (31%) and 14 (48.3%) non-fatal complications. Risk factors for hospital death were "preoperative low cardiac output syndrome" and "time interval between the onset of cardiac failure and surgery" in Group 1, "cardiac failure+sepsis" in Group 2, "time interval between the onset of cardiac failure and surgery" and "particular procedures" in all 61 patients. Sepsis alone and the type of pathogenic agent does not significantly affect the risk of death. The recurrence of acute IE was 12.6% in Group 1, and 20% in Group 2. The incidence of reintervention was 12.6% in Group 1 and 35% in Group 2.(ABSTRACT TRUNCATED AT 250 WORDS)
BACKGROUND: To analyze the results of aortic valve replacement in elderly patients and to evaluate the hemodynamic performance of valvular prostheses, we have retrospectively studied the patients 70 years of age or older, who consecutively underwent aortic valve replacement in our Center. METHODS: From January 1988 to December 1992, a series of 112 patients aged 70 to 88 years (mean 74.8 +/- 3.8 years) underwent aortic valve replacement; 49.1% of patients were male; aortic valvular lesion was: stenosis in 65.2%, insufficiency in 9.8% and mixed stenosis and insufficiency in 25.0%. In 73.2% isolated valve disease was present; in 25.0% coronary artery disease was associated. Preoperatively 58.9% were in New York Heart Association class III, and 29.5% were in class IV. Concomitant extracardiac diseases were present in 73.2%. The types of valve prostheses employed were: mechanical tilting disc (28 cases), mechanical bileaflet (40 cases), bioprosthesis (44 cases). A significantly favourable relationship between body surface area and size of prostheses was evident. RESULTS: Overall hospital mortality was 8.9% (5.4% for elective isolated aortic valve replacement) with significant difference (p = 0.006) related to criteria for surgical indication (elective 6.4%, urgent 10.0%, emergency 37.5%). Valvular lesion, age, sex, associated coronary artery bypass surgery, the values of peak and mean aortic valve gradient, the relative wall thickness and the presence of extracardiac disease have not been identified as risk factors for hospital mortality. The mean follow-up of the 102 discharged patients is 27.1 +/- 16.5 months (range 2 to 64 months). Eight late deaths (7.8%) occurred; the overall actuarial freedom from all deaths (excluding hospital mortality) was 95.6 +/- 2.2% at 1 year and 88.6 +/- 4.0% at 3 and 5 years. Five non fatal valve related complications occurred: hemorrhage in 4 cases (1.8% pt/yr) and hemolysis in 1 case (0.4% pt/yr). Ninety-seven percent of patients were found to be in NYHA functional class I or II. Comparative echocardiographic evaluation of the prostheses showed significant differences in mean gradient: regarding 21 mm size lower in bileaflet than in tilting disc and regarding 23 mm size lower in bileaflet than in tilting disc or bioprostheses. CONCLUSIONS: Aortic valve replacement has proved to be safe and effective in the elderly population and is considered the procedure of choice for aortic valve disease. Although we consider mandatory to choose the valve substitute matching different physiopathological and psychological attitudes of individual patient, mechanical prostheses and particularly bileaflet type for size < or = 21 mm should be preferred.
One hundred and twenty-nine patients underwent posterior mitral annuloplasty with a Gore-Tex tube for mitral regurgitation between January 1982 and June 1991. The hospital mortality was 1.5% (CL = 0.5%-2.5%). The overall survival of hospital survivors was 96.5% +/- 2.7% at five and 86.2% +/- 7.6% at nine years, freedom from cardiac death was 99.1% +/- 0.9% and 95.2% +/- 3.9%, respectively. The actuarial freedom from embolism was 96.1% +/- 2.3% at five and 88.5% +/- 5.5% at nine years. The freedom from endocarditis (one patient) was 100% and 92.6 +/- 7.1%, respectively. Reoperation was necessary in six cases between one and 72 months after the operation (mean 38.5 +/- 30.5 months). The etiology of the valvular insufficiency was rheumatic in all reoperated cases. The freedom from reoperation was 94.1% +/- 3.2% at five and 87.2% +/- 5.6% at nine years. There was no mortality at reoperation. Of the 117 patients alive at the end of follow up and not requiring reintervention, 113 (96.6%) showed good functional improvement and were in NYHA functional class I or II. We conclude that both the immediate and long-term results of reconstructive surgery using the technique of inserting a half-ring on the posterior mitral annulus compare favorably with those obtained using other annuloplasty methods.
Ten patients with acute rupture of the thoracic aorta by blunt trauma were studied. In all instances chest radiographs, computed tomography and aortography were performed. A diagnostic algorithm is proposed for subjects with suspected acute rupture of the thoracic aorta.
Although the aetiopathogenetic role of Helicobacter Pylori (HP) in duodenal ulcer and in chronic gastritis seems now well defined, we have not yet standardized therapeutic schedules to achieve disappearance of HP. This study was aimed at evaluating the efficacy of two different therapeutic schedules, colloidal bismuth alone [CB(1200 mg/day)], vs. association with amoxicillin [CB+A(3 g/day)] for six weeks, to clear HP from antral specimens in a cohort of dyspeptic patients. 49 consecutive patients (23 females, 26 males, mean age 47 years, range 22-69) with HP in gastric specimens, 30 suffering from chronic antral gastritis (CG) and 19 affected by duodenal ulcer (DU) were treated with CB (37 pts) or with CB+A (12 pts). DU patients were given also H2-blockers. These latter patients were all healed at the endoscopic control performed after therapy. 4 out of 13 DU patients (31%) treated with CB were found HP free. In 4 out of 6 DU patients (66%) treated with CB+A, HP was no more detectable. As for CG patients, 12 out of 24 (50%) were free from HP at control when treated with CB, while only 2 out of 6 (33%) when CB+A was administered. This study suggests that colloidal bismuth is more effective when administered associated with amoxicillin, but this concerns only DU patients. No relation between endoscopic healing of UD and HP presence was found.
To define the role of functional tricuspid insufficiency and right ventricular (RV) failure in patients with mitral disease, the data of 121 patients with secondary tricuspid insufficiency that underwent mitral valve replacement (MVR) from January 1982 to December 1987 were analyzed. The mitral hemodynamic lesion was: stenosis in 41 patients (33.9%); insufficiency in 11 (9.1%) and mixed stenosis and insufficiency in 69 (57.0%). NYHA functional class was: II in 4 patients (3.3%), III in 78 (64.5%) and IV in 39 (32.2%). In 100 cases (group 1) with tricuspid insufficiency defined as moderate or severe, a De Vega annuloplasty was performed while in 21 (group 2) with mild tricuspid insufficiency, no tricuspid surgical procedure was performed. Hospital deaths occurred in 17 of 121 patients [14% (CL 10.8-17.0)]. There was no significant difference in hospital mortality between group 1 and group 2 (15% vs 9.5%; P = 0.75). Incremental risk factors for hospital mortality as determined by multivariate analysis, include: cardiothoracic ratio (P = 0.0016), total aortic cross-clamp time (P = 0.006), associated cardiac disease (P = 0.0209) and emergency operations (P = 0.0318). Mean follow-up of surviving patients was 50.1 +/- 28.1 months. Late deaths occurred in 16 patients [15.4% (CL 11.7-18.7)]. The actuarial survival rate was 85.6% and 73.8% at 5 and 9 years, respectively. Nine patients [8.6% (CL 5.9-11.3)] required reoperation. There was no significant difference between group 1 and group 2 in the rate of late cardiac related deaths (5.9% vs 5.3%, P = 0.66) and of tricuspid reoperations (4.7% vs 5.3%, P = 0.62).(ABSTRACT TRUNCATED AT 250 WORDS)
Eighty-two consecutive patients undergoing reoperation for coronary revascularization from January 1980 to November 1990 were reviewed to determine early and late results and predictors of survival. Seventy patients were male and 12 female; age ranged from 36 to 75 years (mean 56.4 +/- 8.1). All were symptomatic for angina. The mean interval between first and second operation was 62.8 +/- 47.8 months (range 1 to 220 months). Angiographic indications for reoperation were: graft failure (34.1%), progression of atherosclerosis in the native coronary circulation (6.1%) and combination of the two (59.8%). Mean ejection fraction was 45.9 +/- 10.2 (range 11 to 67). Surgical indication was elective in 79.3%, urgent in 14.6% and emergent in 6.1%; 199 grafts were performed (2.4 +/- 1 grafts/patient). Hospital mortality was 6.1% (5 cases). Late mortality was 5.2% (4 cases). Actuarial survival rate (including hospital mortality) was 87.9% at 3, 5 and 10 years. Multivariate analysis identified left main stenosis (p = 0.00001), family history of coronary disease (p = 0.003), urgent/emergency operation (p = 0.015) as predictors of increased in-hospital mortality; postoperative myocardial infarction (p = 0.002) and preoperative heart failure (p = 0.01) as predictors of increased late mortality. Follow-up of in-hospital survivors (mean interval 42.7 +/- 25.8 months, range 3 to 120 months) documented 27 cardiac major events (other than death) in 24 patients (32.9%). Actuarial rates of freedom from major cardiac events were 70%, 52.9% and 48.1% at 3, 5 and 10 years respectively. Multivariate analysis identified preoperative ejection fraction (p = 0.01) as predictor of recurrence of angina and preoperative heart failure (p = 0.02) as predictor of occurrence of cardiac major events.
To determine the potential role of emergency surgical revascularization as treatment of acute myocardial infarction (AMI), results in 79 patients undergoing operation for myocardial revascularization during AMI from January 1986 to January 1991 were reviewed. Clinical characteristics for inclusion in the study were: 1) emergency operation; 2) persistent angina not controlled by medical therapy; 3) fixed ST segment elevation until surgical procedure, independently from magnitude of enzymatic levels. The 79 patients were divided in 2 groups: 27 with AMI or evolving AMI (Group 1); 52 with AMI due to complications during PTCA (Group 2). Twenty-eight patients had extremely severe clinical conditions. Mean interval between the beginning of AMI and operation was 4.2 +/- 6.7 hours, with a statistically significant difference between Group 1 (8.7 +/- 10.0) and Group 2 (1.9 +/- 1.0). One hundred ninety-two grafts were performed (2.4 +/- 1.1 grafts/patient). Overall hospital mortality was 10.1% (CL 6.7-13.3) (8 deaths) with a difference between Group 1 [18.5% (CL 10.7-25.3)] and Group 2 [5.8% (CL 4.7-6.6)] (p = 0.074). The incidence of perioperative myocardial infarction was 30.4% (CL 24.9-35.1) for that one in the area of ischemic muscle and 2.6% (CL 0.8-4.1) for infarction in remote muscle. Multivariate analysis for the entire series (79 patients) identified as independent predictors of increased in-hospital mortality: preoperative cardiogenic shock (p = 1.000E-4) and hyperlipidemia (p = 0.008). In Group 1 multivariate analysis identified as independent predictors of increased in-hospital mortality: the attempt of revascularization by PTCA and hyperlipidemia; in Group 2: preoperative need of mechanical ventilatory support.(ABSTRACT TRUNCATED AT 250 WORDS)
From 1 March 1977 through 31 December 1987, 1,252 patients underwent mitral valve replacement with a SORIN-Biomedica 60 degrees tilting-disc prosthesis at our institution. Hospital mortality was 7.3% (91 patients); prosthesis-related deaths, expressed as a percentage of hospital mortality, accounted for 12.1% of these early deaths. The 1,161 patients who survived hospitalization have been followed up for a total of 4,835 patient-years (range, 1 to 128 months; mean, 50.4 +/- 27.3 months). Forty-three (3.7%) of these patients were lost to follow-up. The late mortality was 6.3% (1.5% +/- 0.2% per patient-year), and the 10-year actuarial survival rate, excluding hospital mortality, was 89.1% +/- 1.6%. The 10-year actuarial (and linearized) rates of freedom from valve-related complications were as follows: embolism, 94.4% +/- 1.0% (0.93% +/- 0.1% per patient-year); thrombosis of the prosthesis, 99.8% +/- 0.1% (0.06% +/- 0.03% per patient-year; hemorrhage, 93.7% +/- 1.5% (0.95% +/- 0.1% per patient-year); prosthetic valve endocarditis, 99.3% +/- 0.3% (0.14% +/- 0.05% per patient-year); reoperation, 90.6% +/- 2.1% (1.1% +/- 0.2% per patient-year); and overall complications, 76.6% +/- 2.5% (2.9% +/- 0.2% per patient-year). No structural deterioration was noted. These data not only confirm our previous reports concerning the reliability and durability of the SORIN prosthesis but also reveal a significant reduction, over the long term, in the overall incidence of valve-related complications.