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The Bjork Shiley valve (BSV) is considered as the pioneer among modern disc valves, and eventually evolved into a reliable prosthesis after considerable research and multiple modifications. Various case reports have been published with follow-up of different types of BSV. We are reporting the longest follow-up ever published of a plano-convex type of BSV. Our patient's valve was implanted in 1973 due to a congenital bicuspid aortic valve with concomitant severe, symptomatic aortic stenosis, discovered at the age of 27. She presented with exertional dyspnoea, syncope and chest pain; however, her cardiovascular status remained stable and these symptoms abated after successful valve replacement at the age of 34. She is now 77 years old with no limitations in her activities and is able to walk a few miles most days of the week. Her echocardiograms throughout the decades have shown acceptable gradients across the aortic prosthesis without evidence of haemolysis. Our case report includes a summary of the patient with a discussion of the evidence that supports the durability of the original plano-convex BSV.

ObjectiveThis study was conducted to compare the composites of valve-related complications, namely reoperation, morbidity (defined as permanent neurologic or other functional impairment), and mortality, between bioprostheses and mechanical prostheses for aortic valve replacement.MethodsBetween 1982 and 1998, 2195 bioprostheses were implanted in 2179 patients and 980 mechanical prostheses were implanted in 883 patients. Total follow-up was 16,442 years and 5740 years for bioprostheses and mechanical prostheses, respectively. Eight variables were considered as predictors of risk for the composites of valve-related complications.ResultsLinearized rates for valve-related reoperation were 1.3%/patient-year and 0.3%/patient-year for bioprostheses and mechanical prostheses (P < .001), respectively. All age groups were differentiated, except >70 years. Valve-related morbidity was differentiated for all age groups and overall, for bioprostheses and mechanical protheses, was 0.4 %/patient-year and 2.1%/patient-year, respectively (P < .001). Overall valve-related mortality was 1.0%/patient-year for bioprostheses and 0.7%/patient-year for mechanical prostheses (P = .018). Age and valve-type were predictive risk factors for reoperation and morbidity, whereas age alone was predictive of mortality. Actual freedom from valve-related reoperation favored mechanical prostheses for all age groups, except 61-70 years and >70 years. Actual freedom from valve-related morbidity favored bioprostheses in all age groups, except ≤40 years. Actual freedom from valve-related mortality was undifferentiated in patients 51-60, 61-70, and >70 years.ConclusionNo differences were observed in valve-related reoperation and mortality in patients >60 years. Comparative evaluation gives high priority for bioprostheses in patients >60 years based on improved morbidity profile. This evaluation extends this center’s recommendation for bioprostheses in aortic valve replacement to include patients >60 years.

We evaluated the reliability and usefulness of preoperative brain functional mapping and intraoperative brain monitoring in surgery of the brain tumor located around the sensorimotor region. Combinations with the preoperative identification of central sulcus by magnetoencephalography and the intraoperative motor-evoked potential monitoring assisted in designing the surgical strategy and provided important information during the surgery to minimize postoperative neurological deficit. Especially, decreases of MEPs in amplitude reliably predict impaired motor function during operation.

Background . The Carpentier–Edwards supraannular porcine bioprosthesis experience for more than 18 years has been evaluated by actuarial and actual analysis to determine the clinical performance in aortic valve replacement. Methods . From 1981 to 1998, 1,823 patients (mean age 68.5 years, range 20 to 90 years) underwent 1,846 procedures. Previous coronary artery bypass was performed in 3.1% (56) and previous valve repair/replacement in 6.0% (110). Concomitant coronary artery bypass grafting was performed in 41.5% (756). Results . The overall valve-related complication rate was 4.5%/patient-year (567 patients) with a fatality rate of 0.9%/patient-year (110 patients). The patient survival, at 15 years, was 33.0% ± 3.7% for the 61 to 70 years age group and 13.5% ± 2.4% for the older than 70 years group. At 15 years, the overall actual, cumulative freedom from reoperation was 83.2% ± 1.4%, valve-related mortality was 88.0% ± 1.2%, and valve-related residual morbidity was 92.0% ± 0.8%. The actual freedom from structural valve deterioration at 15 years was 84.2% ± 2.8% for the 61 to 70 years group and 97.1% ± 0.9% for the older than 70 years group. Conclusions . The Carpentier–Edwards porcine bioprosthesis provides excellent freedom from structural valve deterioration, and overall freedom from valve-related morbidity, mortality, and reoperation for aortic valve replacement for up to 15 years. The prosthesis is recommended for patients older than 70 years and for patients 61 to 70 years, especially when extended survival is not anticipated.

From 1975 to 1995, 4200 patients had bioprosthetic valve replacements (2240 aortic, 1607 mitral, 353 multiple) and 2038 had mechanical valve replacements (747 aortic, 928 mitral, 363 multiple). Freedom from major thromboembolism or both major thromboembolism and hemorrhage for aortic and mitral valve replacement at 15 years was significantly greater for bioprostheses than mechanical prostheses. Freedom from valve-related mortality and reoperation for both aortic and mitral valve replacements was the same for bioprostheses and mechanical prostheses. Advancing age increased overall mortality (all positions), valve-related mortality (aortic, mitral), major thromboembolism (aortic), thromboembolism and hemorrhage (aortic, mitral) but decreased reoperation (all positions). Coronary artery bypass grafting increased overall mortality (aortic, mitral) but not valve-related mortality, and it decreased reoperation rate (aortic, mitral). Overall mortality was not influenced by valve type in aortic or multiple valve replacement but it was decreased by bioprostheses in mitral valve replacement. Valve type did not influence valve-related mortality (all positions). Mechanical valves decreased reoperation only for aortic valve replacement but they increased major thromboembolism with and without hemorrhage for both aortic and mitral replacements. There is support for bioprostheses in aortic valve replacement and mechanical prostheses in mitral valve replacement but for neither in multiple valve replacements.

OBJECTIVESThe purpose of this study was to determine the origin of the pulmonary venous systolic flow pulse using wave-intensity analysis to separate forward- and backward-going waves.BACKGROUNDThe mechanism of the pulmonary venous systolic flow pulse is unclear and could be a “suction effect” due to a fall in atrial pressure (backward-going wave) or a “pushing effect” due to forward-propagation of right ventricular (RV) pressure (forward-going wave).METHODSIn eight patients during coronary surgery, pulmonary venous flow (flow probe), velocity (microsensor) and pressure (micromanometer) were recorded. We calculated wave intensity (dP × dU) as change in pulmonary venous pressure (dP) times change in velocity (dU) at 5 ms intervals. When dP × dU > 0 there is a net forward-going wave and when dP × dU < 0 there is a net backward-going wave.RESULTSSystolic pulmonary venous flow was biphasic. When flow accelerated in early systole (S1), pulmonary venous pressure was falling, and, therefore, dP × dU was negative, −0.6 ± 0.2 (x ± SE) W/m2, indicating a net backward-going wave. When flow accelerated in late systole (S2), pressure was rising, and, therefore, dP × dU was positive, 0.3 ± 0.1 W/m2, indicating a net forward-going wave.CONCLUSIONSPulmonary venous flow acceleration in S1 was attributed to a net backward-going wave secondary to a fall in atrial pressure. However, flow acceleration in S2 was attributed to a net forward-going wave, consistent with propagation of the RV systolic pressure pulse across the lungs. Pulmonary vein systolic flow pattern, therefore, appears to be determined by right- as well as left-sided cardiac events.

The Carpentier-Edwards standard porcine bioprosthesis experience to 21 years has been evaluated to determine the influence of structural valve deterioration by valve position in various age groupings.From 1975 to 1988, 1,181 patients had the prosthesis implanted in 1,198 procedures. The mean age of the population was 57.9+/-12.5 years (range, 21 to 85 years). Aortic valve replacement was performed in 564 patients (47.8%); mitral valve replacement, 478 (40.5%); and multiple valve replacement, 132 (11.2%). Concomitant procedures were performed in 337 patients (28.5%), and 140 (11.9%) had previous operations.The early mortality was 8.1% (97), only 0.4% (5) of which were valve-related. The total follow-up was 10,405 years (mean, 8.8+/-5.2 years). The late mortality was 5.7%/patient-year (591), with the valve-related component 1.6%/patient-year (168) with a 13% reoperative mortality (56). The linearized rate of structural valve deterioration was 3.8%/patient-year (395), with overall complications of 7.1%/patient-year (737). The overall survival at 20 years was 17.2%+/-3.1% (p0.05; aortic valve replacement greater than mitral valve replacement or multiple valve replacement). The freedom from structural valve deterioration was, at 18 years, 25.8%+/-2.8% overall, AVR 40.6%+/-4.2%, and MVR 8.5%+/-3.4% (p0.05, aortic valve replacement greater than mitral valve replacement or multiple valve replacement). The freedom from structural valve deterioration for aortic valve replacement was, at 15 years, for patients older than 70 years, 82.9%+/-9.1%; 61 to 70 years, 73.2%+/-4.7%; 51 to 60 years, 58.8%+/-5.4%; 41 to 50 years, 41.7%+/-8.2%; and 21 to 40 years, 25.5%+/-7.8%. The freedom from structural valve deterioration for mitral valve replacement was, at 15 years, for patients older than 70 years, 89.8%+/-7.6%; 61 to 70 years, 22.8%+/-6.3%; 51 to 60 years, 26.3% +/- 5.7%; 41 to 50 years, 11.7%+/-5.6%; and 21 to 40 years, 7.0%+/-4.7%.The prosthesis is recommended for aortic valve replacement for patients older than 70 years and for patients 61 to 70 years (when extended longevity is not anticipated) and for mitral valve replacement for patients older than 70 years.

A retrospective study was conducted to determine the frequency and nature of groin complications when the Vasoseal (Datascope Corp., NJ) hemostasis device was used on 204 occasions to enable removal of the groin sheath in anticoagulated patients. The patients had undergone balloon angioplasty (53%), coronary stenting (20%), and diagnostic angiography (27%). Complications included vascular surgery in 5% including 2 embolized collagen plugs, failure to achieve hemostasis (2%), late external bleeding (2%), purulent discharge (1.5%), a minor ooze of blood (7%), hematomas >6 cm (6%), and hematomas < or = 6 cm (7%). One or more complications occurred with 64 of 204 (30.5%) uses. Multivariate analysis identified diagnostic angiography to be associated with a reduced risk of complications [odds ratio (OR) 0.25], while stent procedure (OR 2.7) and female gender (OR 2.5) were associated with increased risk. This complication rate is similar to other reported series except for a higher rate of vascular surgery. The high incidence of anticoagulation in our study patients (94%) may explain this difference. We recommend caution and adherence to the recommended technique when the device is used in anticoagulated patients.

The Carpentier-Edwards supra-annular porcine bioprosthesis (second generation prosthesis) was implanted in 2438 patients in 2482 operations between 1982 and 1992. The mean age of the population was 64 years with a range from 21 years to 89 years. There were 1334 aortic and 934 mitral valve replacements. The population was divided into five groups: 21 to 40 years (n = 132); 41 to 50 years (n = 189); 51 to 60 years (n = 454); 61 to 70 years (n = 849); and over 70 years (n = 858). There was no difference in sunival by valve position for age groups 21 to 40 years and 41 to 50 years. Sunival within the age groups 51 to 60 years, 61 to 70 years, and over 70 years was greater for patients with aortic compared with mitral and multiple valve replacements. The freedom from structural valve deterioration at 10 years for all age groups was highest for valves in the aortic position. Patients with valves in the mitral position had a higher freedom from structural valve deterioration at 10 years than those who had multiple valve replacement, although not all the differences were significant. There was a lower incidence of structural valve deterioration in the older age groups. We concluded that the use of the Carpentier-Edwards supra-annular porcine bioprosthesis for aortic valve replacement can be extended to patients over 60 years of age, while its use for mitral valve replacement can be extended to those above 70 years of age.

A group of 1195 patients who received biological valve prostheses (mean age 57.3 years, range 8 to 85 years) and a group of 1345 patients who received mechanical heart valves (mean age 56.1 years, range 13 to 91 years) were analyzed for complications by age group (less than or equal to 54 years, 55 to 65 years, and over 65 years). The freedom from thromboembolism and anticoagulant-related hemorrhage at 8 years after aortic valve replacement was significantly higher in patients who received a biological prosthesis in all age groups. The freedom from thromboembolism and anticoagulant-related hemorrhage at 8 years after mitral valve replacement was significantly higher in patients who received a biological prosthesis in the age groups less than or equal to 54 years and over 65 years. The freedom from all valve-related complications at 5 and 8 years after aortic or mitral valve replacement showed the same trend of greater freedom from complications in biological prostheses patients compared with mechanical prostheses in most age groups. However, freedom from valve-related reoperation, mortality, and residual morbidity for aortic and mitral valve replacement for all age groups was not significantly different. These results show that biological prostheses can be considered for patients aged 55 years and older. The prostheses by age group or position at 8 years were not differentiated by valve-related reoperation, mortality, and residual morbidity. t 8 years there is a demonstrated price to pay for a presumed increase in longevity for patients with mechanical valves in the aortic position, reflected by an increase in thromboembolism and anticoagulant-related hemorrhage in all age groups.

Cis- and trans-isomers of alpha-hydroxy-alpha,beta-dibenzyl-gamma-butyrolactone lignans 1a,d-g and 2a,c,d were stereoselectively synthesized in good yields based on the electrophilic addition to the metal enolate of alpha-benzyl-gamma-butyrolactone derivatives 1l-o and 3 as a key step. This method was applied to the syntheses of (+/-)-trachelogenin and (+/-)-guayadequiol, representative examples of the trans- and cis-isomers of alpha-hydroxy-alpha,beta-dibenzyl-gamma-butyrolactone lignan series.

Objectives.This study sought to investigate whether right atrial pressure could be used to estimate pericardial pressure during positive end-expiratory pressure (PEEP).Background.Because of elevated intrathoracic pressure during PEEP, pulmonary capillary wedge pressure may not accurately reflect left ventricular preload. An estimate of pericardial pressure during PEEP would allow assessment of transmural filling pressure.Methods.In eight patients, at the start of cardiac surgery, pericardial and pleural pressures were recorded by balloon transducers placed over the anterolateral left ventricular wall. We also recorded intravascular pressures and left ventricular short-axis area by transesophageal echocardiography.Results.A stepwise increase in PEEP from 0 to 15 cm H2O caused a linear increase in pleural pressure from 0.3 ± 0.6 (mean ± SEM) to 6.1 ± 0.8 mm Hg (p < 0.01). Pericardial pressure increased from 2.3 ± 0.5 to 5.9 ± 0.6 mm Hg (p < 0.01). The correlation between right atrial (Pra) and pericardial pressure (Pperic) was good: Pra= 0.85 × Pperic+ 1.8, r = 0.77. The correlation between changes in right atrial pressure and in pericardial pressure was better: ΔPra= 0.96 × ΔPperic− 0.2, r = 0.97. Pulmonary capillary wedge pressure increased with PEEP (p < 0.05), whereas left ventricular area decreased (p < 0.05). However, there was a progressive reduction in transmural pressure, calculated as wedge pressure minus pericardial pressure (p < 0.05), and in transmural pressure, estimated as wedge pressure minus right atrial pressure (p < 0.05). The estimated transmural filling pressure correlated (r = 0.86) with enddiastolic area.Conclusions.The present observations suggest that right atrial pressure may be used to estimate changes in pericardial pressure with PEEP and that pulmonary capillary wedge pressure minus right atrial pressure is a potentially clinically useful approximation of transmural filling pressure.

The Carpentier-Edwards standard (CE-S) porcine bioprosthesis was implanted in 1214 operations (1975 to 1985) and the Carpentier-Edwards supraannular (CE-SAV) bioprosthesis was implanted in 2,489 operations (1982 to 1992 inclusive). The early mortality was 7.6% and 7.4% for the CE-S and CE-SAV groups, respectively; the late mortality was 5.3% per patient-year and 4.9% per patient-year, respectively. The cumulative follow-up was 9,968 patient-years for the CE-S group and 12,784 patient-years for the CE-SAV group. Concomitant procedures were performed in 26.8% of the patients who received a CE-S and in 40.9% of those who received a CE-SAV (p0.05). The mean age of the patients receiving a CE-S was 57.3 years (range, 8 to 85 years) and was 64.1 years (range, 6 to 89 years) in those receiving a CE-SAV. The CE-S group consisted of 578 atrial valve replacements (AVRs), 512 mitral valve replacements (MVRs), and 115 multiple valve replacements (MRs). The CE-SAV group consisted of 1,335 AVRs, 938 MVRs, and 200 MRs. There was a total of 165 cases of structural valve deterioration (SDV) in the CE-SAV group (AVR, 35; MVR, 98; and MR, 32). The effect of trimming the aortic wall was also considered: 20 of the 931 trimmed prostheses used for MVRs and MRs and none of the 207 reduced-trimmed prostheses exhibited SVD. The cumulative follow-up was 5,422 years for the patients with trimmed prostheses and 470 for those with reduced-trimmed prostheses.(ABSTRACT TRUNCATED AT 250 WORDS)

Porcine bioprostheses have been recommended and used for cardiac valve replacement in the elderly. A review of 1,984 patients with 2,042 operations, performed between 1975 and 1992, has afforded a detailed evaluation of clinical performance by valve positions and age groups within the elderly population. The numbers of operations performed by age groups were 65 to 69 years, 719; 70 to 74 years, 745; 75 to 79 years, 431; 80 to 84 years, 119; and 85 years or older, 28. The early mortality rate overall was 9.5% (195 patients), range 6.9% to 17.8% by age groups (p0.05), and 11.9% with concomitant procedures and 7.6% without (p0.05). The total cumulative follow-up was 10,060 patient-years (mean, 4.9 years). The late mortality rate was 7.0%/patient-year (for age groups, 5.8% to 13.4%/patient-year) (p = not significant). The patient survival at 15 years ranged from 25% +/- 4% for 65 to 69 years to 9% +/- 5% for 75 to 79 years (p0.05). The freedom from valve-related complications and composites at 10 years revealed differences (p0.05) by age groups only for structural valve deterioration: 85% +/- 2% for 65 to 69 years versus 98% +/- 2% for 80 to 84 years. The overall freedom from structural valve deterioration at 10 years for aortic valve replacement was 98% +/- 1%; for mitral valve replacement, 79% +/- 3%; and for multiple replacement, 86% +/- 7% (p0.05, aortic valve replacementmitral valve replacement).(ABSTRACT TRUNCATED AT 250 WORDS)

Prosthetic valve replacement remains the most viable alternative for the treatment of severely diseased heart valves. The cumulative experience of mechanical protheses and bioprostheses was evaluated for a 10-year performance comparison: Carpentier-Edwards standard porcine bioprosthesis (CE-S), 1,214 operations; Carpentier-Edwards supraannular porcine bioprosthesis (CE-SAV), 2,489; and mechanical prostheses, 1,364 operations (St. Jude Medical, Carbomedics, Duromedics, and Björk-Shiley Monostrut). The freedom from thromboembolism and hemorrhage at 10 years was 82% for CE-S, 78% for CE-SAV, and 65% for mechanical prostheses (p0.05). The relationship existed for major thromboembolism and hemorrhage, 91% (CE-S), 87% (CE-SAV), and 88% (mechanical) (p0.05), without clinical relevance. The freedom from structural valve deterioration and valve-related reoperation favored mechanical prostheses (p0.05) at 10 years (structural failure: 78% for CE-S, 81% for CE-SAV, and 99% for the mechanical group; reoperation: 74% for CE-S, 76% for CE-SAV, and 88% for mechanical prostheses). The freedom from fatal reoperation was not clinically different: 96% for CE-S, 99% for CE-SAV, and 99% for mechanical prostheses (p0.05) at 10 years. The freedom from valve-related mortality was not different (p = not significant) at 10 years: 87% for CE-S; 92% for CE-SAV; and 91% for mechanical. The freedom from permanent impairment or residual morbidity, primarily from thromboembolism, was 95% for CE-S, 92% for CE-SAV, and 95% for mechanical group (p0.05) but not clinically relevant.(ABSTRACT TRUNCATED AT 250 WORDS)

Structural deterioration is the major reason for reoperation in patients with valvular bioprostheses. We present findings on a mode of structural deterioration, the pathology of which has not yet been well characterized. Between January 1990 and December 1992, 39 Carpentier-Edwards standard valves (CESTD) and 50 Carpentier-Edwards supra-annular valves (CESAV) were operatively removed at St. Paul's Hospital. Of these, 14 bioprostheses (6 CESTD [15%] and 8 CESAV [16%]) showed dehiscence of a single commissural region from its stent post. Age at initial implantation was not significantly different between patients with CESAV (52.1 ± 5.4 years) and CESTD (45.5 ± 5.1 years, p = ns), but time from implantation to reoperation was shorter for CESAV as compared with CESTD (7.9 ± 0.5 vs. 13.3 ± 0.7 years, respectively, p < 0.01). The vast majority (12 14 ) of dehiscences were in mitral bioprostheses, and all patients presented with valvular regurgitation. Accompanying structural changes (calcification and cuspal tears/perforations), graded semiquantitatively (absent = 0, mild = 1, moderate = 2, and severe = 3), ranged from absent to severe in individual valves. Radiographically detected calcification was greater in CESTD compared with CESAV (CESTD 1.3 ± 0.3 vs. CESAV 0.5 ± 0.3, p < 0.05). Differences in severity of cuspal tears or perforations were not present. Thus, commissural region dehiscence from the stent post of Carpentier-Edwards porcine bioprosthetic valves in the mitral position is a relatively common form of structural deterioration associated with valvular incompetence. It may occur more readily in Carpentier-Edwards supra-annular valves.

Patients often are disconnected temporarily from the ventilator before sternotomy to avoid entering the pleural space with the sternal saw. Although this practice is widespread, it is based on questionable physiologic principles. To evaluate the efficacy of this maneuver in reducing the incidence of pleural space violation with first-time sternotomy, 126 cardiac patients were randomized prospectively to either lungs inflated or deflated during sternotomy with the surgeon blinded to the particular assignment. The incidence of pleural space violation overall was 12%, occurring in 15% of patients with deflated lungs and in 9% of those with inflated lungs ( p = 0.455 by χ 2 test). Examining the effect of the direction of sternotomy on pleural space entry revealed a 4% incidence with sternotomy starting at the xiphoid versus a 21% incidence with sternotomy starting at the sternal notch ( p = 0.009 by χ 2 test). Preexisting hyperinflation of the lungs as evaluated by chest radiograms did not influence the incidence of pleural space violation. To reduce pleural space violation, sternotomy should be performed from the xiphoid to the sternal notch. More importantly, disconnecting the patient from the ventilator does not reduce pleural space violation with sternotomy and its further use is not indicated. These findings are discussed in the context of relevant heart-lung patho-physiology.

Cis- and trans-isomers of α-hydroxy-α,β-dibenzyl-γ-butyrolactone lignans 1a,d−g and 2a,c,d were stereoselectively synthesized in good yields based on the electrophilic addition to the metal enolate of α-benzyl-γ-butyrolactone derivatives 1l−o and 3 as a key step. This method was applied to the syntheses of (±)-trachelogenin and (±)-guayadequiol, representative examples of the trans- and cis-isomers of α-hydroxy-α,β-dibenzyl-γ-butyrolactone lignan series.

We describe a rare case of traumatic persistent trigeminal artery (PTA) - cavernous sinus fistula. Cerebral angiography showed direct communication between the right PTA and the cavernous sinus which was treated by transcathether arterial embolization. Although previous reports have indicated the use of more coils to treat this condition, we successfully treated the patient with only two coils placed near the orifice of the fistula after sufficient anatomical evaluation.

The Carpentier-Edwards supra-annular porcine bioprosthesis has been utilized at the University of British Columbia since its introduction in 1982. The prosthesis was designed to improve hemodynamics with the supra-annular configuration and to reduce tissue failure with low-pressure glutaraldehyde preservation of the porcine aortic tissue. The prosthesis was inserted in 1,956 patients with 2,129 prostheses between 1982 and 1989. The mean age of the patient population was 62.7 years (range 13 to 87 years). The mean follow-up was 3.7 years per patient. The freedom from thromboembolism and antithromboembolic therapy-related hemorrhage at 8 years was 92% for aortic valve replacement (AVR), 83% for mitral valve replacement (MVR), and 92% for multiple valve replacement (MR) (p less than 0.05, AVR greater than MR greater than MVR). The freedom from structural valve deterioration was 86% for AVR, 73% for MVR, and 96% for MR at 8 years (p less than 0.05, AVR greater than MR greater than MVR). The freedom from nonstructural valve dysfunction and prosthetic valve endocarditis was not different between positions (p = NS). The freedom from valve-related mortality at 8 years was 98% for AVR, 94% for MVR, and 98% for MR (p less than 0.05, AVR greater than MR greater than MVR). The freedom from residual morbidity was not different at 8 years (p = NS). The freedom from treatment failure (valve-related mortality and residual morbidity) was 96% for AVR, 89% for MVR, and 94% for MR (p less than 0.05, AVR greater than MVR greater than MR).(ABSTRACT TRUNCATED AT 250 WORDS)

The Carpentier-Edwards standard porcine bioprosthesis was implanted in 1190 patients (1201 operations, 1303 valves) between January 1975 and June 1986; most implants were before 1982. The mean age of the patients was 57.2 years (range 8 to 85 years). The early mortality was 7.6% (aortic valve replacement 5.1%, mitral valve replacement 8.8%, and multiple valve replacement 15.3%). Late mortality was 3.9% per patient-year (aortic valve replacement 3.6%, mitral valve replacement 4.2%, and multiple valve replacement 3.8%). The total cumulative follow-up period was 6737 years. Thromboembolism was 1.5% per patient-year (fatal 0.4% per patient-year) (minor 0.6%, major 0.9%); antithromboembolic therapy-related hemorrhage was 0.5% (fatal 0.1%); prosthetic valve endocarditis was 0.6% (fatal 0.2%); nonstructural dysfunction was 0.5% (fatal 0.2%); and structural valve deterioration and/or primary tissue failure was 1.5% per patient-year (fatal, 0.2% per patient-year). Thromboembolism and structural valve deterioration were the significant complications, structural valve deterioration occurring primarily between the sixth and 10th year of evaluation. The overall patient survival was 65.0% for aortic valve replacement and 54.8% for mitral valve replacement (p

The present authors' experience with mitral valve reconstruction was reviewed to determine the influence of anatomical and functional abnormalities on mortality and reoperation.Between 1991 and 2001, a total of 397 patients (mean age 59.0 +/- 13.4 years) underwent mitral valve reconstruction at the authors' institution. Patients were grouped according to the Carpentier functional classification as follows: type I, n = 88 (mean age 57.4 years; range: 24-81 years); type II, n = 169 (mean age 59.8 years; range: 16-81 years); type IIIa, n = 44 (mean age 52.8 years; range: 22-78 years); type IIIb, n = 85 (mean age 65.1 years; range: 33-82 years); and congenital (C), n = 11 (mean age 36.2 years; range: 18-65 years).The total follow up was 1,485.8 patient-years (pt-yr). Early mortality was: type I, 3.4% (n = 3); type II, 0; type IIIa; 2.3% (n = 1); type IIIb, 9.4% (n = 8); and C, 0 (p = 0.0028, IIIbII and C). The late mortality was: type I, 2.1%/pt-yr (n = 6); type II, 1.1%/pt-yr (n = 7); type IIIa, 1.8%/pt-yr (n = 4); type IIIb, 4.3%/pt-yr (n = 12); and C, 1.7%/pt-yr (n = 1) (p = 0.0035 IIIbII). The overall survival at 10 years was 79.6 +/- 4.2% (p0.001, IIIIIb; p = 0.029, IIIIb; p = 0.046, III). The reoperations were: type I, 1.4%/pt-yr (n = 4); type II, 1.9%/pt-yr (n = 12); type IIIa, 0.9%/pt-yr (n = 2); type IIIb, 0.4%/pt-yr (n = 1); and C, 0 (p = 0.0435 IIIIIb). Among the 19 reoperations there were 17 replacements, one re-repair, and one annuloplasty. The failures were predominantly type II, posterior (n = 5) and anterior (n = 5), or a combination (n = 2). The overall freedom from reoperation was 92.0 +/- 2.2% (p = NS between groups).Mitral valve reconstruction can be performed in all four functional categories with generally satisfactory results, except possibly for functional ischemic disease. The results of surgery for degenerative disease afford the opportunity for early surgical management, if proven techniques are adhered to in order to minimize the risk of reoperation. The repair of ischemic disease due primarily to ventricular dysfunction is in a state of evolution.

Objective Experience with the Carpentier-Edwards supra-annular porcine bioprosthesis (Edwards Lifesciences, Irvine, Calif) has been evaluated longitudinally over 20 years. Clinical performance was evaluated by actuarial and actual analysis. Hemodynamic performance was evaluated by echocardiographic/Doppler assessment. Morphology of structural failure was evaluated from pathologic examinations. Methods From 1981 through 1999, 1823 patients (mean age, 68.9 ± 10.9 years; range, 19-89 years) underwent 1847 procedures. Concomitant coronary artery bypass was performed in 788 (42.7%) patients. Previous valve procedures were performed in 107 (5.8%) patients, and other cardiac procedures were performed in 87 (4.7%) patients. Results The overall valve-related complication rate was 4.36% per patient-year (630 patients), with a fatality rate of 0.96% per patient-year (139 patients). Patient survival at 18 years was 15.8% ± 1.6%. Overall late mortality rate was 6.3% per patient-year. Overall actual cumulative freedom at 18 years from reoperation was 85.0% ± 1.2%, valve-related mortality was 88.7% ± 1.1%, and valve-related residual morbidity was 96.3% ± 5.0%. Actual freedom from structural valve deterioration at 18 years was 86.4% ± 1.2% overall, 90.5% ± 1.8% for age 61 to 70 years, and 98.2% ± 0.6% for age greater than 70 years. Structural valve deterioration presented with pathologic evidence consistent with stenosis in 27.6% and insufficiency in 72.4%. Hemodynamic performance at 1 year revealed normal effective orifice area indexes for sizes 23 to 27 mm and mild-to-moderate reduction for size 21 mm. Conclusions The Carpentier-Edwards supra-annular aortic porcine bioprosthesis continues to provide excellent freedom from structural valve deterioration and overall freedom from valve-related residual morbidity, mortality, and reoperation up to 18 years. Hemodynamic performance is satisfactory. The prosthesis remains recommended for patients older than 70 years and for patients 61 to 70 years of age, especially when comorbid risk factors are not anticipated to provide extended survival.

Objective: The predominant complication of bioprostheses is structural valve deterioration and the consequences of re-operation. Prosthesis choice for aortic valve replacement surgery (bioprostheses and mechanical prostheses), is influenced by valve-related complications (mortality and morbidity) of the prosthesis type chosen. The purpose of the study is to determine the mortality and risk assessment of that mortality for aortic bioprosthetic failure. Methods: From 1975 to 1999, 3356 patients received a heterograft bioprosthesis in 3530 operations. The procedures were performed with concomitant coronary artery bypass (CAB) in 1388 procedures and without in 2142 procedures. Three hundred twenty-two re-operations for structural valve deterioration were performed in 312 patients with 22 fatalities (6.8%). Of the 322 re-replacements, 36 had CAB and 286 had isolated replacement; the mortality was 8.3% (3) and 6.6% (19), respectively. Eleven predictive factors inclusive of age, concomitant CAB, urgency status, New York Heart Association (NYHA) at Re-op and year of Reop (year periods) were considered. Results: The mortality for 1979– 1986 was 6.1% (2/33); 1987– 1992, 7.7% (8/104); and 1993– 2000, 6.5% (12/185) (pNS). The mortality by urgency status for elective/urgent was 6.4% (19/299); and emergent, 13.0% (3/23) (pNS). The mortality for NYHA I/II was 2.0% (1/50), III 4.2% (8/191) and IV 16.0% (13/81) (P ¼ 0:00063), for gender was male 4.6% and female 13.3% (P ¼ 0:011), for age at implant ‘No’ (no re-operation) 51.6 ^ 12.2 years and ‘Yes’ (yes re-operation) 59.9 ^ 7.3 years (P ¼ 0:00004), for age at explant ‘No’ 62.6 ^ 12.7 years and ‘Yes’ 70.6 ^ 6.5 years (P ¼ 0:00001), and for age at explant , 60 years 0.0% (0/110), 60 – 70 years 8.5% (10/117) and . 70 years 12.6% (12/95) (P ¼ 0:0011). The predictive risk factor assessment by multivariate regression analysis revealed only NYHA III Odds Ratio 1.7 and IV 7.8 P ¼ 0:0082. For the period 1993– 2000 of re-operations only gender was significant; age at implant, age at explant, CAB pre-Re-op, CAB concomitant with Re-op, urgency at Re-op, ejection fraction, valve lesion and NYHA at Re-op were not significant. Conclusions: Bioprosthetic aortic re-operative mortality can be lowered by re-operation in low rather than medium to severe NYHA functional class. The routine evaluation of patients can achieve earlier low risk re-operative surgery.

Background— The predominant complication of bioprostheses is structural valve deterioration and the consequences of reoperation. The purpose of the study was to determine the mortality and risk assessment of that mortality for mitral bioprosthetic failure. Methods and Results— From 1975 to 1999, 1 973 patients received a heterograft bioprosthesis in 2 152 operations. The procedures were performed with concomitant coronary artery bypass (CAB) in 694 operations and without in 1 458 operations. There were 481 reoperations for structural valve deterioration performed in 463 patients with 34 fatalities (7.1%). Of the 481 re-replacements, 67 had CAB and 414 had isolated replacement; the mortality was 11.9% (8) and 6.3% (26), respectively. Eleven predictive factors inclusive of age, concomitant CAB, urgency status, New York Heart Association (NYHA; reoperation), and year of reoperation (year periods) were considered. The mortality from 1975 to 1986 was 9.8% (6/61), from 1987 to 1992 it was 10.8% (20/185), and from 1993 to 2000 it was 3.4% (8/235) (I versus III P =0.0458, II versus III P =0.0047). The mortality by urgency status was elective/urgent 6.0% (26/436) and emergent 17.8% (8/45) ( P =0.00879). The mortality was NYHA I/II 0.00% (0/37), III 5.1% (14/273), and IV 11.7% (20/171) ( P =0.0069). The predictive risk factors by multivariate regression analysis were age at implant, odds ratio (OR) 0.84 ( P =0.0113); age at explant, OR 1.2 ( P =0.0089); urgency, OR 2.8 ( P =0.0264); NYHA, OR 2.5 ( P =0.015); 1975–1986 versus 1993–2000 of reoperations, OR 5.8 ( P =0.0062); and 1987–19 92 versus 1993–2000, OR 4.0 ( P =0.0023). For the period 1993 to 2000 of reoperations, only age at implant and age at explant were significant; NYHA class, urgency status, and concomitant CAB were not significant. Conclusion— Bioprosthetic mitral reoperative mortality can be lowered by reoperations on an elective/urgent basis in low to medium NYHA functional class. The routine evaluation of patients can achieve earlier low risk reoperative surgery.

Calcification in vestibular schwannoma is extremely rare. A 36-year-old man presented with a history of decreased hearing on the left since childhood. Computed tomography showed a left cerebellopontine angle lesion protruding into the porus acousticus and enlarging the internal auditory meatus, with significant deposits of calcification. Histological and immunohistochemical examination, including staining for CD-34, a myeloid progenitor cell antigen, found highly degenerated schwannoma with collagen-rich tissue, calcification, formation of bone, abnormal vessels of various sizes, and old haemorrhage with marked haemosiderin-laden macrophages. Most of the surgical specimen was sclerotic collagenous tissue containing sparse spindle-shaped cells which formed approximately 90% of the total specimen. However, the spindle-shaped cells were partly concentrated into islands forming the cellular part (approximately 10% of the total). The spindle-shaped cells in both parts showed almost typical immunohistochemical characteristics of schwannoma. However, many spindle-shaped cells in only the sclerotic part were positive for CD-34, which is widely used for the diagnosis of solitary fibrous tumours. Cerebellopontine angle tumour showing fibromatous tissue, including calcification, may contain foci of typical schwannoma. Careful histological examination with detailed immunohistochemical staining is required for the correct diagnosis. In particular, spindle-shaped cells occasionally show positive immunoreactivity for CD-34 antigen in the areas of degenerated and calcified schwannoma characteristic of our case.

A 56-year-old woman, who had been suffering from idiopathic cold agglutinin disease and treated unsuccessfully with prednisolone and cyclosporine A for 6 months, was referred to our hospital in November 1998. She was given methylprednisolone pulse therapy followed by low-dose cyclophosphamide, but her anemia did not improve. We then began administration of intermittent high-dose cyclophosphamide (1,200 mg/day, every 4 weeks), and this resulted in a dramatic increase of her hemoglobin level and improvement of her symptoms. She is currently receiving 500 mg of cyclophosphamide every 2 months and showing a good response. Intermittent high-dose cyclophosphamide therapy can be an effective treatment for refractory cold agglutinin disease.

Rabeprazole is a new, potent, proton pump inhibitor. The metabolism of rabeprazole is less dependent on CYP2C19 genetic polymorphism.A total of 102 Helicobacter pylori-positive patients with gastric ulcer were randomly allocated to three groups: rabeprazole 10 mg (RAC10), rabeprazole 20 mg (RAC20) or rabeprazole 40 mg (RAC40) plus amoxicillin 750 mg and clarithromycin 200 mg twice daily for 7 days. CYP2C19 genotype was determined by the polymerase chain reaction-restriction fragment length polymorphism method.All-patients-treated-based eradication rates in patients treated with RAC10, RAC20 and RAC40 were 83%, 77% and 90%, respectively, and per protocol-based eradication rates were 83%, 80% and 90%, respectively. The eradication rates in the three groups were not significantly different. There was also no significant difference between the all-patients-treated-based eradication rate in CYP2C19 extensive metabolizers and that in poor metabolizers (86% vs. 77%). Adverse events were 12% in extensive metabolizers and 23% in poor metabolizers, and the difference in these incidence rates was also not statistically significant.Triple therapy with 10 mg of rabeprazole combined with amoxicillin/clarithromycin is effective for Japanese patients with H. pylori infection, and the H. pylori eradication rate is not affected by CYP2C19 genetic polymorphism.

A 68-year-old man, who had suffered a tick bite one week previously, consulted his home doctor because of fever and an erythematous rash around the bite scar. He underwent a skin biopsy, and Borrelia garinii was detected, from which Lyme disease was diagnosed. He received amoxicillin for two weeks and his symptoms disappeared. After 6 months he noticed swelling of his cervical, axillary and inguinal lymph nodes. A biopsy sample was taken from a left cervical lymph node, and this revealed angioimmunoblastic T-cell lymphoma. The patient achieved a complete remission after chemotherapy. The relationship between Lyme disease and lymphoma is discussed.

The bileaflet St. Jude Medical mechanical prosthesis has been implanted for over 20 years. The purpose of this study was to evaluate the clinical performance of the bileaflet CarboMedics (CM) prosthesis, which was introduced in 1986.The CM prosthesis was implanted in 1,258 patients (709 males, 549 females; mean age 60.9 +/- 12.3 years) between 1989 and 1997. The prosthesis distribution was aortic valve replacement (AVR) 613; mitral valve replacement (MVR) 447; and multiple replacement (MR) 231. Coronary artery bypass (CAB) was performed in 334 (26.6%) patients; previous procedures had been performed in 346 (27.5%). The age distribution was60 years (n = 527), 61-70 years (n = 424) and70 years (n = 307). Risk factors assessed were age or age groups, gender, CAB, previous surgery, rhythm, valve position, status and NYHA functional class. The total follow up was 4,765.0 patient-years (pt-yr), and was 98.4% complete.The early mortality rate was 5.6% (AVR 4.8%, MVR 3.7%, MR 11.5%). The late mortality rate was 3.7%/pt-yr (n = 174), and valve-related mortality 1.1%/pt-yr (n = 50). The total thromboembolism (TE) rate was 4.1%/pt-yr (n = 195) (p = NS by valve position); the major TE rate was 1.9%/pt-yr and fatal TE rate 0.31%/pt-yr (n = 15). The valve thrombosis rate was 0.31%/pt-yr (n = 15; 11 MVR, four MR). The fatal thrombosis rate was 0.06%/pt-yr (n = 3; two MVR, one MR). The hemorrhage rate was 2.7%/pt-yr (n = 128) and fatal hemorrhage rate 0.4%/pt-yr (n = 20). The reoperation rate was 1.0%/pt-yr (n = 46), fatal 0.1%/pt-yr (n = 5). The actuarial freedom from overall TE at eight years was 77.3 +/- 2.8%; major TE 88.5 +/- 1.6%, and hemorrhage 76.4 +/- 3.2% (all p = NS by valve position). There were no independent predictors of overall TE and TE exclusion of early events. The only predictor for TE major was status (emergencyurgentelective). The actuarial freedom from valve-related mortality at eight years was 91.4 +/- 1.8% (p = NS by position) (actual freedom 93.0 +/- 1.3%). The actuarial freedom from valve-related reoperation was 91.1 +/- 2.4% (p0.05; AVRMVR and MR, MVRMR) (actual freedom 92.2 +/- 2.7%). Overall survival rate at eight years was 68.2 +/- 2.3% (p0.05; AVRMVR and MR, MVRMR).The clinical performance of the CarboMedics mechanical prosthesis is satisfactory when implanted in the mitral, aortic and multiple positions.

The clinical performance of porcine bioprostheses for valve replacement has been evaluated for over three decades by actuarial analysis as the standard for reporting time-related results. Actual or cumulative incidence analysis provides a complementary method to determine the manifestations of valve-related complications due primarily to structural valve deterioration. Valve-related mortality and reoperation of porcine bioprostheses for aortic and mitral valve replacement was compared by actuarial and actual methodology.The Carpentier-Edwards porcine bioprostheses were implanted between 1975 and 1995 as 2,237 aortic valve replacements (AVR) and 1,582 mitral valve replacements (MVR). Coronary artery bypass was performed in 36.4% of AVR, and 30.6% of MVR. Fatal valve-related complications occurred in 7.6% of AVR and 11.3% of MVR. The cumulative follow up was 14,810 patient-years (mean 6.6 years) for AVR and 9,718 patient-years (mean 6.1 years) for MVR.Patient survival, and actuarial and actual freedom from valve-related mortality and valve-related reoperation was reported at 15 years. For AVR, survival in the 61-70 years age group was 30.9%, freedom from valve-related mortality was 79.3% and 86.9% respectively, and freedom from valve-related reoperation 79.0% and 88.1% respectively. For AVR, survival in the70 years age group was 18.1%, freedom from valve-related mortality 72.8% and 84.9% respectively, and freedom from reoperation 86.3% and 96.1% respectively. For MVR, survival in the 61-70 years age group was 16.1% at 15 years, freedom from valve-related mortality was 59.5% and 79.5% respectively, and freedom from valve-related reoperation 32.6% and 71.0% respectively. For MVR, survival in the70 years age group was 2.8% at 15 years, valve-related mortality was 26.1% and 82.0% respectively, and freedom from valve-related reoperation 83.4% and 93.3% respectively.The actual freedom from valve-related mortality and valve-related reoperation (primarily from structural valve deterioration), provides further evidence to consider porcine bioprostheses for AVR in patients aged60 years, and for MVR in patients aged70 years. The freedom from valve-related mortality supports the use of porcine bioprostheses for MVR in patients aged 61-70 years. Patient survival is influenced to the greatest extent by factors other than valve-related mortality.

The clinical performance of porcine bioprostheses for valve replacement surgery has been evaluated for over three decades by actuarial analysis as the standard for reporting time-related results. The incidence of structural valve deterioration (SVD) is used for the selection of prostheses for various subsets of patients. Actual or cumulative incidence analysis may provide a superior method to determine durability of bioprostheses.To compare actuarial versus actual methodology in determining the durability of porcine bioprostheses for aortic (AVR) and mitral valve replacement (MVR).Carpentier-Edwards porcine bioprostheses were implanted between 1975 and 1995 in 2237 AVR and 1582 MVR. The mean age for AVR patients was 65.4+/-12 years and for MVR patients 61.7+/-12 years. The cumulative follow-up for AVR was 14,810 years (mean 6.6+/-4.7) and for MVR 9718 years (mean 6. 1+/-4.5).For AVR the actual freedom from SVD was 87.4+/-2. 0% and 95.6+/-1.8% in those aged 61 to 70 years and more than 70 years, respectively; the actuarial freedom was 75.9+/-4.2% and 82. 3+/-7.9%, respectively. For MVR the actual freedom from SVD was 69. 4+/-2.5% and 92.9+/-1.9% for those aged 61 to 70 years and more than 70 years, respectively; the actuarial freedom was 25.5+/-5.7% and 79. 5+/-6.0%, respectively. Predictors of freedom from SVD for AVR were identified as advancing age, falling into the age groups 61 to 70 and those older than 70 years, and intermediate valve sizes; predictors for MVR were advancing age and age older than 70 years.Comparison of methods of durability assessment revealed that actual freedom from SVD supports porcine bioprostheses for AVR in patients more than 60 years of age and for MVR in patients more than 70 years of age. This evaluation with experience to 15 years supports the indications for use of porcine bioprostheses.

Objective: The experience with the Carbomedics (CM) and the St. Jude Medical (SJM) bileaflet mechanical prostheses was evaluated to determine thromboembolic and hemorrhagic complications and predictive risk factors. Methods: From 1989 to 1994, a total of 625 patients had mitral valve replacement (CM, 240; SJM, 385); 32.5% (203), concomitant procedures and 32.8% (205), previous cardiac surgery, primarily valve replacement procedures. Results: The pre-operative variables did not distinguish the populations, except for previous surgery CM 37.9% and SJM 29.6% (P , 0:05). The pre-operative variables (type of prostheses, cardiac rhythm, coronary artery bypass, NYHA III/ IV, advancing age, gender, urgency status and previous surgery) were not predictive of overall thromboembolism (TE), major TE, minor TE, prosthesis thrombosis and hemorrhage (P not significant; Pa NS). The linearized rate of total TE events for overall MVR was 5.0%/patientyear (CM 4.4; SJM 5.4). The # 30 day major crude rate was 0.44%, while the . 30 day late major event rate was 2.0%/patient-year. Of the total TE events 91% of # 30 days and 75%, . 30 days had an INR , 2.5 at or immediately prior to the event. The thrombosis rate (included in TE events) was 0.63%/patient-year (ten events, four managed successfully with thrombolysis, five successfully with reoperation, and one fatality identified at autopsy). The freedom, at 5 years, from major/fatal TE, thrombosis and hemorrhage from anticoagulation was 88.2%, and 89.5% exclusive of early events. Conclusions: This non-randomized prospective observational evaluation of the CarboMedics and St. Jude Medical prostheses has not revealed any differentiation in performance of the prostheses. The study serves as a single institution experience with the potential for future comparative evaluation. q 1999 Elsevier Science B.V. All rights reserved.

Performance with regard to structural valve deterioration (SVD) with the Carpentier-Edwards standard (CE-S) and supraannular (CE-SAV) (Baxter Healthcare Corp, Irvine, CA) porcine bioprostheses was evaluated to determine whether progress in reduction of structural failure has been achieved with technological changes.The CE-S was implanted during 567 aortic valve replacement (AVR) and 486 mitral valve replacement (MVR) procedures, and the CE-SAV was implanted during 1,670 AVR and 1,096 MVR procedures. The failure mode of early stent dehiscence with the CE-SAV prosthesis, thought to be controlled by manufacturing changes in 1986 and 1987, supported comparison of the CE-SAV with censored cases of stent dehiscence. Stent dehiscence accounted for only 1.2% (1 of 81) and 14.1% (29 of 205) of AVR and MVR CE-SAV failures, respectively.The only difference for AVR for freedom from SVD occurred in the 21- to 40-year age group at 15 years and was 68% for the CE-SAV and 31% for the CE-S (p0.05). In the 61- to 70-year age group, freedom from SVD at 15 years was 76% for the CE-S and 84% for the CE-SAV; for the 71-year or higher age group, freedom from SVD was 89% and 95%, respectively (p = NS). For MVR freedom from SVD was different only in the 71-year or higher age group and was 90% for the CE-S and 59% for the CE-SAV (p0.05). Freedom from SVD was reduced but was similar (p = NS) for the other age groups. For AVR the actual freedom from SVD at 15 years for the CE-S and CE-SAV was, respectively, 79% and 72% for the 51- to 60-year age group, 86% and 91% for the 61- to 70-year age group, and 98% and 98% for the 71-year or higher age group. For MVR, these rates were, respectively, 69% and 75% for the 61- to 70-year age group and 96% and 89% for the 71-year and higher age group.The technologic advancements made in the second-generation CE-SAV bioprosthesis to reduce the incidence of structural failure have not uniformly been successful. The actual freedom from SVD provides evidence for implantation of porcine bioprostheses for AVR in age groups 61 to 70 years and 71 years or higher and for MVR in the age group 71 years or higher.

To determine major thromboembolic and hemorrhagic complications and predictive risk factors associated with aortic valve replacement (AVR), using bileaflet mechanical prostheses (CarboMedics and St. Jude Medical).A case series.Cardiac surgical services at the teaching institutions of the University of British Columbia.Patients 2 age groups who had undergone AVR between 1989 and 1994 were studied. Group 1 comprised 384 patients younger than 65 years. Group 2 comprised 215 patients 65 years of age and older.The linearized rates of major thromboembolism (TE) occurring after AVR were 1.54%/patient-year for group 1 and 3.32%/patient-year for group 2; the rates for major TE occurring more than 30 days after AVR were 1.13%/patient-year for group 1 and 1.55%/patient-year for group 2. The crude rates for major TE occurring within 30 days of AVR were 1.04% for group 1 and 3.72% for group 2. The death rate from major TE in group 1 was 0.31%/patient-year and in group 2 was 0.88%/patient-year. Of the major TE events occurring within 30 days, 100% of patients in both age groups were inadequately anticoagulated at the time of the event, and for events occurring more than 30 days after AVR, 45% in group 1 and 57% in group 2 were inadequately anticoagulated (INR less than 2.0). The overall linearized rates of major hemorrhage were 1.54%/patient-year for group 1 and 2.21%/patient-year for group 2. There were no cases of prosthesis thrombosis in either group. The mean (and standard error) overall freedom from major TE for group 1 patients at 5 years was 95.6% (1.4%) and with exclusion of early events was 96.7% (1.3%); for group 2 patients the rates were 90.0% (3.2%) and 93.7% (3.0%), respectively. The mean (and SE) overall freedom from major and fatal TE and hemorrhage for group 1 patients was 90.1% (2.3%) and with exclusion of early events was 91.2% (2.3%); for group 2 patients the rates were 87.9% (3.1%) and 92.5% (2.9%), respectively. The 5-year rate for freedom from valve-related death for group 1 patients was 96.3% (2.1%) and for group 2 patients was 97.2% (1.2%).The thromboembolic and hemorrhagic complications after AVR with bileaflet mechanical prostheses occur more frequently and result in more deaths in patients 65 years of age and older than in patients years younger than 65 years.