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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.

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.

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.

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.

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.

Objective: The experience with the St. Jude Medical (SJM) and CarboMedics (CM) bileaflet mechanical prostheses was evaluated to determine thromboembolic and hemorrhagic complications and predictive risk factors. Methods: From 1989 to 1994, a total of 246 patients had multiple valve replacement (SJM, 140; CM, 106); concomitant procedures 20.3% (50) [coronary artery bypass 10.6% (26)] and 53.7% (132) previous cardiac surgery, primarily valve replacement procedures. The pre-operative variables [coronary artery disease, previous cardiovascular surgery, concomitant procedures, valve lesion (except mitral stenosis), status, atrial fibrillation, and NYHA III:IV] did not distinguish the prosthesis-type (pNS). Results: The prosthesis-type and the pre-operative variables, including atrial fibrillation, were not predictive of overall thromboembolism (TE). The linearized rate of total TE events for overall multiple replacements (MR) was 5.4%:patient-year (minor, 2.52; major 2.85); the total TE for CM and SJM was 5.4%:patient-year, respectively. The 530 day major TE crude rate was 0.82%, while the \ 30 day major event rate was 2.7%:patient-year. Of the total (major and minor) TE events 100% (3) of 5 30 days and 72% (29), \ 30 days had an INR B2.5 at or immediately prior to the event. The thrombosis rate (included in total TE events) was 0.67%:patient-year (4 events, 100% INR B2.5). Of the various TE event categories the prosthesis-types (CM and SJM) were not differentiated (pNS). The freedom, at 5 years, from major:fatal TE, thrombosis and hemorrhage from anticoagulation was 89.39 3.8% for CM and 87.99 3.7% for SJM and, 91.393.5% and 89.393.7%, respectively, (pNS) exclusive of early events. Conclusions: The performance of the CarboMedics and St. Jude Medical prostheses in multiple valve replacement surgery in this non-randomized prospective study revealed no significant differences in performance with regard to thromboembolic and hemorrhagic complications. © 1998 Elsevier Science B.V. All rights reserved.

Abstract The influence of prosthetic type, age, and coronary artery bypass grafting (CABG) on valve-related complications by valve position was evaluated in a population of 2353 bioprosthesis patients (mean age, 66.5 years; range, 13 to 89 years) and in a population of 1112 mechanical prosthesis patients (mean age, 59.1 years; range, 13 to 91 years). The follow-up was complete to 96% and 98%, respectively, for the bioprosthesis and mechanical prosthesis groups. The patient groups were evaluated by actuarial assessment of survival and valve complications and composites. Preoperative factors were evaluated for determination of significant independent predictors by multivariate proportional-hazard regression analysis. CABG was an influential factor in the actuarial analysis. Survival was superior for aortic mechanical replacements without CABG and for mitral replacements, both biological and mechanical, without CABG ( P P P =NS). The freedom from valve-related mortality was not influenced by CABG for either position ( P =NS). The freedom from valve-related reoperation was greater for biological prostheses with CABG than without CABG for both aortic and mitral replacements ( P P =NS) but a predictor of survival and valve-related reoperation for mitral valve replacement (MVR) ( P P P P =NS). Advancing age was a significant covariate for AVR for all areas of assessment. Advancing age for MVR provided a lower rate of survival and greater freedom from valve-related mortality and reoperation ( P

The role of porcine bioprostheses in cardiac valve replacement has been under review for several years. The literature deals primarily with age as a determinant of durability, as well as the intermediate-term performance of various prostheses. The performance of the Carpentier-Edwards first-generation standard porcine bioprosthesis is presented over the long-term with further documentation on age determinants.The "Guidelines for Reporting Morbidity and Mortality After Cardiac Valvular Operations" were used for definitions of valve-related complications, categorization, and statistical methods. The valve-related complications were evaluated in a time-related manner by actuarial life-table techniques. The Lee-Desu statistic test was used for comparison of performance by valve positions and age groups. Hazard function rates were demonstrated for complications and composites.Of the Carpentier-Edwards porcine bioprostheses implanted in 1,195 patients (1,214 operations, 1,315 valves) commencing in 1975 the early mortality was 7.6% (92). The early mortality without concomitant procedures was 6.1% and with 11.7%. The late mortality was 5.3% per patient-year; 4.6% patient-year without and 7.5% per patient-year with concomitant procedures. The valve-related causes of late mortality (131) were thromboembolism (41), antithromboembolic hemorrhage (14), prosthetic valve endocarditis (20), nonstructural dysfunction (12), and structural valve deterioration (44). The valve-related deaths (early, 7; late, 124) were 21.2% of the total 617 total deaths. Reoperation for valve-related complications was performed in 406 patients (4.1% per patient-year), of which 327 were for structural valve deterioration (3.3% per patient-year). Mortality for reoperation was 0.5% per patient-year (49 patients) or 12.1%. Of the 49 deaths, 33 were caused by structural valve deterioration. The linearized occurrence rate for thromboembolism was 1.6% per patient-year (major, 0.9% per patient-year, and minor, 0.7% per patient-year). The fatal thromboembolic rate was 0.4% per patient-year (41), undifferentiated by valve position. The freedom from thromboembolism was 76% at 17 years (p = not significant by valve position) (major, 87%; fatal, 93%). The freedom from prosthetic valve endocarditis was 92% at 17 years (p = not significant by valve position). The freedom from reoperation, at 15 years, was 38%: aortic (AVR), 55%; mitral (MVR), 20%; and multiple valve replacement (MR), 24% (p0.05 AVRMVR, MR). The freedom from structural valve deterioration, at 15 years, was 41%; AVR, 58%; MVR, 21%; MR, 36% (p0.05 AVRMVR, MR). The freedom from structural valve deterioration was greater for advancing age groups (p0.05); AVRor = 70 years 96% at 12 years, and 65 to 69 years 94% at 12 years and 82% at 15 years; MVRor = 70 years 85% at 12 years, and 65 to 69 years 54% at 12 years. The freedom from valve-related mortality was 73% at 17 years: AVR, 80%; ; MVR, 61%; and MR, 67% (p0.05 AVRMVR, MR). The freedom valve-related residual morbidity was 94% (p = not significant by valve position).The Carpentier-Edwards standard porcine bioprosthesis continues to provide satisfactory clinical performance to 17 years. Thromboembolism is a more serious problem than structural failure: 92 major thromboembolic events with 41 fatalities compared with 44 fatalities of which 33 occurred with reoperation. The prosthesis is especially recommended for patients more than 65 years of age for AVR and more than 70 years of age for MVR.

The performance of porcine bioprostheses and mechanical prostheses in multiple valve replacement operations was evaluated in 494 patients with 553 operations between 1975 and 1992. Porcine bioprostheses were implanted in 351 multiple replacement operations and 202 operations were performed with mechanical prostheses. The mean age of the bioprosthesis group was 59.1 ± 14.4 years and of the mechanical prostheses group, 55.9 ± 13.3 years. Concomitant procedures, primarily coronary artery bypass grafting, were performed in 27.4% (96 patients) of the bioprosthesis group and 20.8% (42 patients) of the mechanical prosthesis group ( p = not significant [NS]). The early mortality for the bioprosthesis group (BP) was 12.0% (42 patients), whereas for the mechanical prosthesis (MP) group it was 10.9% (22 patients) with no difference ( p = NS) for the performance with or without concomitant procedures, primarily coronary artery bypass grafting. The total cumulative follow-up was 1,914 years for BP and 458 years for MP group. The late mortality was different between the groups ( p p = NS) for performance of concomitant procedures and not different ( p = NS) for the absence of concomitant procedures, 5.6%/patient-year for BP and 2.2%/patient-year for MP. The freedom from thromboembolism- and antithromboembolic-related hemorrhage favored the biological population ( p p = NS), at 10 years, 83.9% ± 3.3% for bioprostheses and 96.8% ± 1.4% for mechanical prostheses. The freedom from residual morbidity (permanent impairment) was different ( p p = NS) for BP, 94.5% ±1.5% at 5 years and 60.4% ± 4.4% at 10 years and for MP, 95.5% ± 2.5% at 5 years and 86.8% ± 8.5% at 10 years. The freedom from fatal reoperation was 93.5% ± 2.5% for BP and 98.8% ±0.8% for MP at 10 years ( p = NS). The overall complications favored the biological group ( p p = NS). Twenty-four patients had incidental replacement of an additional bioprosthesis at reoperation without a fatality. Bioprostheses in multiple valve replacement operations provided less valve-related morbidity and equivalent freedom from reoperative mortality when clinical performance of these bioprostheses and mechanical prostheses was evaluated.

The Carpentier-Edwards supraannular porcine bioprosthesis, a second-generation biologic prosthesis, has had clinical performance assessment to 12 years. This bioprosthesis was used in 2,489 operations in 2,444 patients between 1982 and 1992, inclusive (mean age 64.1 years, age range 6 to 89 years). There were 1,335 aortic valve replacements (AVR), 938 mitral valve replacements (MVR), and 200 multiple valve replacements (MR). Concomitant procedures were performed in 1,017 cases (40.9%). The age group distribution was: 35 years or younger, 83 patients; 36 to 50 years, 245; 51 to 64 years, 728; 65 to 69 years, 458; and 70 years and older, 975. The total follow-up was 12,785 patient-years (mean, 5.1 years) and was 96% complete. The early mortality rate was 7.4% (185 patients), and the late mortality was 4.9%/patient year (623). Concomitant procedures influenced both early and late mortality ( p p MVR, MR). The freedom from thromboembolism was not different by valve position. The freedom from major thromboembolism at 12 years was 82% ± 4% ( p = not significant by valve position). The overall freedom from antithromboembolic hemorrhage was 96% ± 1% at 12 years ( p MVR > MR). The overall freedom from valverelated reoperation at 12 years was 58% ± 5% ( p MVR, MR), and from valve-related mortality 89% ± 2% ( p MVR > MR). The freedom from residual morbidity (permanent impairment) at 12 years was 87% ± 4% ( p = not significant by valve position). The freedom from structural valve deterioration overall at 12 years was 63% ± 5%; at 10 years it was 90% ± 2% for AVR, 72% ± 3% for MVR, and 61% ± 8% for MR ( p MVR, MR). The freedom from structural valve deterioration by age groups by valve position was not significant for 35 years and less, but was significant for 36 to 50, 51 to 64, and 70 years and older ( p MVR > MR), and for 65 to 69 years ( p MR > MVR). The freedom from structural valve deterioration at 10 years after AVR by valve position for age groups was 36 to 50 years, 85% ± 6%; 70 years and older, 99% ± 1%; 51 to 64 years, 84% ± 4%; and 65 to 69 years, 96% ± 2% ( p

From 1975 through 1992 inclusive, reoperative valve replacement (REOP) was required by 12.9% of patients (708/5,499). Of 1,355 patients with mechanical prostheses (MP), 46 (3.4%) came to REOP versus 662 of 4,144 patients (16%) with biological prostheses (BP). Early REOP mortality rate was 17.4% (8/46) for MP and 10.6% (70/662) for BP (p = not significant). It was higher with age greater than 75 years (p0.05) and trended higher with concomitant procedures and with increasing number of REOPs (p = not significant). The percentage freedom from REOP at 5 and 10 years for all BP was 96.0% +/- 0.4% and 74.9% +/- 1.1% compared with 93.6% +/- 1.2% and 87.9% +/- 2.5% for MP. The most common cause of REOP in the BP patients was structural valve deterioration, which was uncommon in patients with MP (72% versus 2% of REOP but only 15% versus 0.1% of initial implants). Nonstructural dysfunction was the leading cause of REOP in the MP group (65% versus 11%). Prosthetic valve endocarditis (18% versus 10%) and thromboembolic complications (10% versus 1%) were also more frequent causes of REOP in MP patients. However, the increased relative role of these factors with MP is due to the minimal incidence of structural valve deterioration. When related to the original choice of MP versus BP, only thromboembolic complication (3.8 times) was more prevalent as a cause of REOP in patients receiving MP at their previous procedure (p = not significant). For patients who previously received BP, structural valve deterioration (69 times) was more likely to lead to REOP than with MP (p0.01).(ABSTRACT TRUNCATED AT 250 WORDS)

The Carpentier-Edwards standard porcine bioprosthesis was implanted in 1,195 patients in 1,213 operative procedures between 1975 and 1987, with the majority of implants performed prior to 1982 at the University of British Columbia. The mean age of the patient population was 57.2 years (range 8 to 85 years). The mean follow-up was 7.4 years per patient. The freedom from the combination of thromboembolism and antithromboembolic therapy-related hemorrhage at 15 years was 79.5% for aortic valve replacement (AVR), 72% for mitral valve replacement (MVR), and 84% for multiple valve replacement (MR) (p less than 0.05, AVR greater than MR greater than MVR). The freedom from structural valve deterioration at 15 years was 71% for AVR, 41% for MVR, and 41% for MR (14 years) (p less than 0.05, AVR greater than MVR greater than MR). The freedom from nonstructural dysfunction and prosthetic valve endocarditis did not distinguish the valve positions (p = NS). The freedom from valve-related mortality from all causes including reoperation was 92% for AVR, 78% for MVR, and 77% for MR at 15 years (p less than 0.05, AVR greater than MVR greater than MR). The freedom from residual morbidity was not significantly different between valve positions (p = NS). The freedom from treatment failure (valve-related mortality and residual morbidity) at 15 years was 87% for AVR, 72% for MVR, and 75% for MR (p less than 0.05, AVR greater than MR greater than MVR). The freedom from all complications at 14 years was 50% for AVR, 25% for MVR, and 27% for MR (p less than 0.05, AVR greater than MR greater than MVR).(ABSTRACT TRUNCATED AT 250 WORDS)

The Carpentier-Edwards standard porcine bioprosthesis was implanted in 1,000 operations (988 patients with 1,092 valves) between 1975 and 1981. The mean age of the patients was 56.8 years (range 8 to 85 years). During the years 1975 and 1981, approximately 97% of the total valvular surgery population received the prosthesis. The early mortality was 7.8% (including patients with concomitant procedures including coronary artery bypass and ascending aortic aneurysm resection). Late mortality was 3.8% per patient-year. The total cumulative follow-up was 5,937 years. Thromboembolism (TE) was 1.3% per patient-year (fatal 0.4%/patient-year) (minor 0.4%; major 0.9%); antithromboembolic therapy-related hemorrhage (ATH) 0.5% (fatal 0.1%); prosthetic valve endocarditis (PVE) 0.5% (fatal 0.2%); periprosthetic leak (PPL) 0.4% (fatal 0.2%); clinical valve dysfunction (CVD) 0.2% (fatal 0.02%); and structural valve deterioration (SVD)/primary tissue failure 1.6% per patient-year (fatal 0.2%/pt-yr). Thromboembolism and SVD occurring primarily between the sixth and tenth year of evaluation, were the significant complications. The overall patient survival was 60.5% +/- 2.4% at 10 years. The patients were classified as 93.5% NYHA functional Class III and IV, preoperatively and 93.1% Class I and II, postoperatively. The freedom at 10 years from TE was 82.9% +/- 2.7%; SVD 76.9% +/- 2.9%; and reoperation 70.8% +/- 3.1%. Freedom from all valve-related complications at 10 years was 54.3% +/- 3.1%; valve-related mortality 86.4% +/- 2.3%; mortality and reoperation (valve failure) 64.0% +/- 3.2%; mortality and residual morbidity (treatment failure) 82.3% +/- 2.6%; and mortality, residual morbidity, and reoperation (valve failure and dysfunction) 60.6% +/- 3.2%. There were 61 valve-related deaths of a total 352 deaths (early 7, late 54) (TE 21; ATH 7; CVD 1; PVE 12; PPL 9; and SVD 11). Valve-related reoperations were performed in 128 patients (TE 3; CVD 4; PVE 14; PPL 17; and SVD 90). The standard Carpentier-Edwards porcine bioprosthesis has provided very satisfactory clinical performance and afforded patients excellent quality of life. Primary tissue failure is the significant long-term complication.

The Carpentier-Edwards porcine bioprosthesis compares favorably to other value substitutes, with a low incidence of valve-related complications after up to 6 years' follow-up. From April, 1976, to February, 1978, 397 prostheses were implanted in 355 patients at the University of British Columbia and the Montreal Heart Institute: aortic valve replacement (AVR), 155; mitral valve replacement (MVR), 154; tricuspid valve replacement (TVR), five; multiple replacement (MR), 41 patients. Previous cardiac operations had been performed in 58 patients (16.3%). Concomitant cardiac procedures, including myocardial revascularization, were performed in 66 patients (18.5%). The 30 day mortality was 8.7% (31 patients (AVR, 4.5%; MVR 9.0%; TVR 20%; MR 21.9%). The cumulative follow-up was 1,367 patient-years (range 6 to 81 months, mean 51 months). The late mortality is 3.9% per patient-year (AVR 3.4%, MVR 3.6%, MR 6.3%). The long-term valve-related complication rates (expressed as percent per patient-year and number of events) are as follows; thromboembolism (AVR 1.1 [seven], MVR 1.7 [10], MR 3.2 [four]; prosthetic valve endocarditis (AVR 0.6 [four], MVR 0.3 [two], MR 1.6 [two]); primary tissue failure (AVR 0.16 [one], MVR 1.0 [six], MR 1.6 [two]); anticoagulant-related hemorrhage 0.07 (one); and reoperation (AVR 0.48 [three], MVR 1.32 [eight], MR 2.4 [three]). Actuarial survival rates at 6 years, including operative deaths, are as follows: AVR 81.4% +/- 5.6%, MVR 70.0% +/- 6.7%, and MR 52.1% +/- 12.5%. The overall survival rate was 74.0% +/- 4.5% at 6 years. The freedom from all valve-related complications at 72 months was 83.9% +/- 4.8%. The freedom from valve-related death was 97.3% +/- 1.8% at 72 months. The freedom from valve-related death and reoperation at 72 months was 91.5% +/- 3.8%, and the freedom from reoperation alone was 93.4% +/- 3.5%. There were no deaths due to reoperation for primary tissue failure. Performance to date with the Carpentier-Edwards porcine bioprosthesis has been excellent, with an evaluation interval extending from 60 to 81 months.

The investigational Carpentier-Edwards supra-annular valve was implanted in 592 patients from November, 1981, to February, 1984 (aortic valve replacement in 286, mitral valve replacement in 259, and multiple valve replacement in 47, for a total of 638 prostheses). A previous cardiac operation had been performed in 77 patients (13%). Concomitant procedures were performed in 202 patients (34.1%), including coronary artery bypass in 163 patients. The patient evaluation was 98.6% complete. The early mortality was 7.4% (44 patients) and the late mortality was 6.2% per patient-year (41 patients). The valve-related causes of late mortality were thromboembolism (five), anticoagulant-related hemorrhage (one), and prosthetic valve endocarditis (one). The overall patient survival, including operative death, was 85% at 2 years. The linearized occurrence rate for valve-related complications was 5.6% per patient-year (37 events)—thromboembolism 2.7% per patient-year (18), anticoagulant-related hemorrhage 1.2% (eight), prosthetic valve endocarditis 0.8% (five), and periprosthetic leak 0.9% per patient-year (six). There were no cases of primary tissue failure or structural failure. At 2 years, the freedom from valve-related complications was 86.9%, from valve-related mortality, 98.7%, and from valve-related mortality and reoperation, 97.7%. This valve is fixed in glutaraldehyde at low pressure and is designed to improve durability. It has provided a low incidence of valve-related complications without structural failure. The structural design of the prosthesis does not always conform to the anatomy of bicuspid aortic valves.

Summary Acute aortic dissection is a medical emergency that demands immediate recognition and early precise angiographic diagnosis. One hundred seventeen patients were found to have aortic dissection between 1980 and 1986. Clinical presentation is of importance since hypertension favors the presence of type B dissection, whereas normotension or hypotension is usually indicative of a type A lesion. Supportive treatment should allow stabilization for diagnosis by angiography or computerized tomography in order to proceed with early surgical repair of all type A dissections. Management of the acute type B patient should initially be medical, but immediate surgical treatment should be carried out if there is failure to control the hypertension, continued pain, expansion or rupture of the aneurysm (including appearance of a pleural collection), development of a neurologic deficit, or evidence of compromise of a major infradiaphragmatic aortic branch. Any delay in surgical treatment once an indicative complication is identified will have an early adverse effect on prognosis. By applying these guidelines, an overall 65 to 75 percent hospital survival rate should be achieved.

The case histories of patients with primary cardiac neoplasms are presented. The mean age was 49.6 years and females predominated (17:8). Nineteen of the tumors were benign (76%), 18 myxomas and one mesenchymal hamartoma. There were six malignant neoplasms; two myxosarcomas, two rhabdomyosarcomas, one skeletal angiomatosis, and one malignant melanoma. The clinical presentation was congestive heart failure in 17 patients and peripheral embolization in five (one patient with both). There were four asymptomatic patients. Antemortem diagnosis was made in 20 patients and five were discovered at autopsy. After 1970, almost 95% of the patients were diagnosed preoperatively while only 14% of the patients had preoperative diagnosis before 1970. Cardiac catheterization and echocardiography were the most useful diagnostic procedures performed but a computed tomographic scan of the heart performed in a patient with right ventricular hamartoma was of great value in delineating the lesion. Twenty-one patients underwent a total of 26 operations but complete excision of the lesion was possible in only 16 patients. Three patients underwent extensive resection and reconstruction. Associated procedures consisted of coronary artery bypass grafts in two patients, mitral valve annuloplasty in one, and a right lung biopsy. Although there was no operative mortality following the original procedure, one patient died after a third operation for recurrence and another underwent unsuccessful emergency pericardiectomy. All patients with malignant lesions died from recurrence 6 to 13 months postoperatively while only three patients in the benign group died and these of unrelated causes. Surgical resection is the treatment of choice for all primary cardiac neoplasms since it is curative in the benign tumors and may prolong life for up to a year with malignant tumors.

Primary tissue failure (structural valve deterioration) has been documented as the most prominent complication of porcine bioprostheses. The influence of age on primary tissue failure has received limited consideration. From 1975 to 1986, 1,301 Carpentier-Edwards standard porcine bioprostheses were implanted in 1,183 patients in 1,201 operations. Of the total number of prostheses, 97.7% were implanted prior to 1983. The mean follow-up was 5.6 years and was 97.5% complete. Primary tissue failure was identified in 96 patients (98 operations) at reoperation (95) or autopsy (3). One hundred four (104) prostheses were involved. Thirty-one failed after aortic valve replacement (AVR), 49 after mitral valve replacement (MVR), and 24 after multiple-valve replacement (18 patients). There were 47 male and 49 female patients. The mean age at implantation was 47 years (range, 8 to 72 years). The mean implantation time was 74.0 months. The freedom from primary tissue failure at 10 years is 77.0 +/- 2.9% overall; for AVR, 83.1 +/- 3.7%; for MVR, 72.1 +/- 4.9%; and for multiple-valve replacement, 65.5 +/- 7.8%. The freedom from deterioration for patients less than 20 years of age is significantly less than that for other age groups. The freedom from deterioration increased by decades; the greatest freedom was noted in patients 70 to 80 years old and 80 years old or older. The freedom from deterioration at 10 years for patients less than 30 years of age is 26.8 +/- 17.2%; 30 to 59 years, 77.4 +/- 3.0%; and 60 years and older, 83.1 +/- 4.2%.(ABSTRACT TRUNCATED AT 250 WORDS)

From January, 1975, until August, 1978, 509 porcine valves were implanted in 465 patients. Patient follow-up was done at 6 to 45 months (mean 20.2 months), for a total observation of 713 patient-years. There were six early embolic events (mitral four, aortic two). Four of these six patients were in atrial fibrillation and none was receiving anticoagulants at the time of the embolism. There were 18 late emboli. Four occurred in patients with aortic prostheses and produced mild, transient symptoms only. Fourteen occurred in patients with mitral or multiple prostheses. These resulted in death in five patients and permanent sequelae in three. The rate of embolic events was 1.32/100 patient-years for aortic prostheses, 3.27/100 patient-years for mitral prostheses, and 4.91/100 patient-years for multiple prostheses. Thirteen of the 14 patients with emboli were in atrial fibrillation and only three were receiving anticoagulants. Anticoagulation is vital in patients with mitral prostheses who remain in atrial fibrillation, but it appears unnecessary in patients with aortic prostheses and those with mitral or multiple prostheses who remain in sinus rhythm.

The Mitral Medical Mitroflow pericardial bioprosthesis was implanted in 99 operations (99 patients with 104 valves) between 1984 and 1987. The mean age of the patients was 62.8 years (range 28 to 94 years). The early mortality was 6.1% (including patients with concomitant procedures--coronary artery bypass and ascending aortic aneurysm resection). Late mortality was 2.3% per patient-year. The total cumulative follow-up was 172 years. Thromboembolism (TE) was 4.1% per patient-year (fatal 1.2% per patient-year) (minor 2.3%; major 1.8%); antithromboembolic therapy-related hemorrhage (ATH) 0.6% (fatal 0.6%); prosthetic valve endocarditis (PVE) 0.6% (fatal 0%); periprosthetic leak (PPL) 0.6% (fatal 0%); clinical valve dysfunction (CVD) 1.2% (fatal 0%); and structural valve deterioration/primary tissue failure (SVD) 1.2% per patient-year (fatal 0% per patient-year). Thromboembolism was the significant complication. SVD occurred in two patients during the third year of evaluation. The overall patient survival was 89.2 +/- 3.3% at four years. The patients were classified as 91.9% NYHA functional Class III and IV preoperatively and 97.7% Class I and II postoperatively. The freedom at four years from TE was 88.5% +/- 4.9%; SVD 92.5 +/- 5.1%; and reoperation 89.8% +/- 5.3%. Freedom from all valve-related complications at four years was 76.8% +/- 6.6%; valve-related mortality 97.2 +/- 2.0%; mortality and reoperation (valve failure) 87.3% +/- 5.5%; mortality and residual morbidity (treatment failure) 95.5% +/- 2.6%; and mortality, residual morbidity, and reoperation (valve failure and dysfunction) 85.6% +/- 5.7%. There were three valve-related deaths of a total of ten deaths (early 2; late 1) (TE 2; ATH 1; CVD 0; PVE 0; PPL 0; and SVD 0). Valve-related reoperation was performed in four patients (TE 0; CVD 0; PVE 1; PPL 1; and SVD 2). The Mitral Medical Mitroflow pericardial bioprosthesis has provided very satisfactory clinical performance and afforded patients excellent quality of life.

Primary motor disorders of the esophagus can be managed surgically with excellent results. Between the years 1972 and 1983, 40 patients were managed by us. The patients ranged in age from 14 to 79 years (mean 36.3 years). Thirty-six patients were managed primarily by the authors and 4 patients secondarily. The distribution of the hypodynamic states were achalasia in 29 patients, vigorous achalasia in 5 patients, and diffuse spasm in 1 patient, whereas the hyperdynamic states were squeeze syndrome in 2 patients, super-squeeze syndrome in 1 patient, and hypertensive lower esophageal sphincter in 2 patients. Of the 36 patients in hypodynamic states, 27 had a modified Heller myotomy and reconstruction of the gastroesophageal junction with a Belsey fundoplication and 9 had only a modified Heller myotomy. There was only one patient with reflux esophagitis. It occurred after myotomy and Belsey fundoplication for a hypertensive lower esophageal sphincter and hiatus hernia. Four patients were managed secondarily for complicated recurrent problems, one with a Belsey fundoplication and three with a jejunal interposition graft. We recommend myotomy, with or without a Belsey fundoplication, for management of primary motor disorders and avoidance of total Nissen fundoplication and a lengthening Collis gastroplasty.

Leukocyte kinetics were investigated in 22 patients undergoing cardiopulmonary bypass to determine the nature of the changes in the white blood cell count associated with this procedure. Both polymorphonuclear leukocytes and lymphocytes were taken up by the lung as pulmonary blood flow was lowered, but only polymorphonuclear leukocytes were taken up as blood flow was restored. The complement 3a level was increased approximately twice the control value within 2 minutes of going on bypass and remained elevated throughout the procedure. The peripheral white blood cell count doubled during the bypass procedure owing to a release of polymorphonuclear leukocytes and their precursors from the bone marrow. The increase in polymorphonuclear leukocytes was prevented by hyperthermia but reappeared quickly when the body temperature was restored to 36 degrees to 37 degrees C.

The Carpentier-Edwards supra-annular porcine bioprosthesis was implanted in 1,576 operations (1,536 patients with 1,704 valves) between 1981 and 1987. The mean age of the patients was 61.9 years (range 13 to 87 years). During the years 1981 and 1987, approximately 90% of the total valvular surgery population received the prosthesis. The early mortality was 7.0% (included patients with concomitant procedures including coronary artery bypass and ascending aortic aneurysm resection). Late mortality was 4.0% per patient-year. The total cumulative follow-up was 4,237 years. Thromboembolism (TE) was 2.4% per patient-year (fatal 0.4% per patient-year) (minor 1.2%; major 1.3%); antithromboembolic therapy-related hemorrhage (ATH) 0.5% (fatal 0.07%); prosthetic valve endocarditis (PVE) 0.5% (fatal 0.2%); periprosthetic leak (PPL) 0.3% (fatal 0%); clinical valve dysfunction (CVD) 0.3% (fatal 0.02%); and structural valve deterioration/primary tissue failure (SVD) 0.2%/patient-year (fatal 0%). Thromboembolism and structural valve deterioration were the significant complications, SVD occurring primarily between the fourth and fifth year of evaluation. The overall patient survival was 77.1% +/- 1.4% at five years. The patients were classified as 89.6% NYHA functional Class III and IV preoperatively and 96.1% Class I and II postoperatively. The freedom at five years from TE was 90.6% +/- 1.0%; SVD 98.9% +/- 0.5%; and reoperation 95.9% +/- 0.9%. Freedom from all valve-related complications at five years was 84.1% +/- 1.3%; valve-related mortality 96.8% +/- 0.7%; mortality and reoperation (valve failure) 92.9% +/- 1.1%; mortality and residual morbidity (treatment failure) 93.7% +/- 0.9%; and mortality, residual morbidity, and reoperation (valve failure and dysfunction) 90.0% +/- 1.2%. There were 28 valve-related deaths of a total 280 deaths (early 4, late 24) (TE 17; ATH 3; CVD 1; PVE 7; PPL 0; and SVD 0). Valve-related reoperations were performed in 32 patients (TE 2; CVD 4; PVE 7; PPL 11; and SVD 8). The supra-annular Carpentier-Edwards porcine bioprosthesis has provided very satisfactory clinical performance and afforded patients an excellent quality of life. The long-term durability of this low pressure glutaraldehyde fixed prosthesis will be determined by observation over the next five to seven years.

Selection of valve type for predominant usage is obscured by limiting the analysis to prosthesis-related rather than patient-oriented failure modes. In this report, "treatment failure" is defined as a valve-related death or permanent patient disability; successful reoperations are excluded, and emboli with permanent residua are included. Results with the Starr-Edwards Silastic ball valve (Oregon) and the Hancock (Stanford) and Carpentier-Edwards (Vancouver) porcine valves are compared using this new definition of treatment failure. Evaluated according to structural failure, the mechanical valve is superior to the tissue valve, and using the Stanford definition of valve failure, it becomes so between 5 and 10 years. Using treatment failure, tissue valves are superior at 5 years; at 10 years in the aortic position, the results are comparable; and in the mitral position at 8 to 10 years, tissue valves show a continued but small advantage.

Since 1975 porcine bioprostheses have been the valve substitute of choice for cardiac valvular replacement at Vancouver General Hospital and St. Paul’s Hospital in Vancouver, Canada. From 1975 to May 1984 porcine bioprostheses were implanted in 2066 patients (99%) and mechanical prostheses, in 23 patients (1.0%), the majority being ST. JUDE MEDICAL® (SJM) valves.

The Carpentier-Edwards porcine valve prosthesis has afforded our patients a satisfactory quality of life and a low incidence of valve-related complications at follow-up periods of up to five years. From December, 1975 to March, 1980, 768 prosthesis were implanted in 700 patients (aortic valve replacement [AVR], 334; mitral valve replacement [MVR], 292; tricuspid valve replacement [TVR), 6; and multiple valve replacement, 68). One hundred and thirty-seven patients (19.6%) had had previous cardiac operations. Concomitant aortocoronary bypass was performed in 127 patients (18.1%). There were 52 hospital deaths, for a mortality of 7.4% (AVR, 4.8%; MVR, 9.2%; multiple valve replacement, 11.8%). Total follow-up was 1,047 patient-years (range, 6 to 60 months, mean, 19.4 months). There were 33 late deaths (AVR, 1.7% per patient-year; MVR, 4.0% per patient-year; multiple valve replacement, 8.1% per patient-year). Eight percent of AVR patients and 47% of MVR and multiple valve replacement patients were taking anticoagulants. The valve-related complications (expressed as events per 100 patient-years) were as follows: (1) thromboembolism (AVR, 0.94; MVR,. 1.42; multiple valve replacement, 4.62); (2) infective endocarditis (AVR, 0.94; MVR, 0.24; multiple valve replacement, 2.31); (3) periprosthetic leak (AVR, 0.94; MVR, 0.71; multiple valve replacement, 3.46); and (4) valve dysfunction (MVR, 0.24). The only case of valve dysfunction was a calcified mitral prosthesis in a 13-year-old girl. Actuarial survival, including operative deaths, was as follows: AVR, 90.5% at 36 months; MVR, 84% at 36 months; and multiple valve replacement, 74% at 24 months. Of surviving patient, 93.6% were in New York Heart Association Class I or II at follow-up evaluation.

This study was designed to compare two methods of cardiac drainage on the rate of change of cardiac temperature and volume of cardioplegic solution required to maintain the cardiac temperature less than or equal to 12 degrees C in patients undergoing coronary artery bypass surgery. Two groups of 10 patients were studied who were comparable in age, sex, and smoking history. In Group 1, cardiac drainage was achieved by using single-port drainage cannulae in the superior and inferior vena cava with caval tapes. Group 2 patients had a caval atrial cannula to drain the noncoronary collateral flow from the right atrium as well as that from the venae cavae. Both groups had a sump line in the left ventricle to drain the bronchopulmonary anastomotic blood flow. Results from the study showed that there was no difference between groups in the initial amount of cold cardioplegic solution required to arrest and cool the heart or the initial recording of ventricular temperatures. However, the volume of cardioplegic solution required to maintain the cardiac temperature at less than or equal to 12 degrees C after administration of the initial volume was less (P less than 0.05) for Group 2 than Group 1. Group 2 also had a slower rate of increase in cardiac temperature than Group 1 (P less than 0.01). Results from this study indicate that the constant removal of blood from both cardiac chambers during coronary artery bypass surgery significantly reduces the rate of myocardial rewarming and decreases the amount of cardioplegic solution required to maintain a given cardiac temperature.

A hospital survival rate of 71% was obtained in 31 consecutive cirrhotic patients who underwent portal decompression during the acute bleeding episode. All patients were operated upon within 48 hours and most within six hours of the start of the hemorrhage. Patients with jaundice, ascites, or mild encephalopathy were accepted for surgery, and only patients with severe encephalopathy were rejected. There were five deaths in hospital and two late deaths from hepatic failure. Five of the surviving patients have evidence of some encephalopathy. This unfortunate complication of present techniques of portal decompression, either emergency or elective, will be diminished by techniques which allow more selective decompression. With a midline incision, portacaval, splenorenal or mesenteric renal shunts are possible and thus a preoperative splenoportogram may be avoided in the emergency situation. This experience suggests that the common policy of restricting portal decompression to those patients who have survived and recovered from their hemorrhage is unrealistic.