Performance of bioprostheses and mechanical prostheses assessed by composites of valve-related complications to 15 years after aortic valve replacement.

OBJECTIVE: This 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. METHODS: Between 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. RESULTS: Linearized 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 < or =40 years. Actual freedom from valve-related mortality was undifferentiated in patients 51-60, 61-70, and >70 years. CONCLUSION: No 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.

Performance of bioprostheses and mechanical prostheses assessed by composites of valve-related complications to 15 years after mitral valve replacement.

OBJECTIVE: Predominant concerns of patients undergoing valve replacement surgery are risks of death, stroke, antithrombotic bleeding, and reoperation related to the replacement prosthesis. The purpose of this study was to compare valve-related reoperation, morbidity (permanent impairment), and mortality between bioprostheses and mechanical prostheses for mitral valve replacement. METHODS: Between 1982 and 1998, a total of 959 bioprostheses were implanted in 943 patients, and a total of 961 mechanical prostheses were implanted in 839 patients. Total follow-ups were 5730 years for bioprostheses and 5271 years for mechanical prostheses. Eight variables were considered as predictors of risk for the composites of valve-related complications. RESULTS: The linearized occurrence rates for valve-related reoperation were 3.7 events/100 patient-years for bioprostheses and 0.5 events/100 patient-years for mechanical prostheses ( P < .001), with all age groups differentiated except older than 70 years. Valve-related morbidity was undifferentiated for bioprostheses and mechanical prostheses. Valve-related mortalities were 1.7 events/100 patient-years for bioprostheses and 0.7 events/100 patient-years for mechanical prostheses ( P < .001). Predictors of valve-related reoperation were age and valve type. The only predictor of valve-related morbidity was age, whereas age and valve type were predictors for valve-related mortality. Actual freedom from valve-related reoperation favored mechanical prostheses in all age groups except older than 70 years (91.7% +/- 2.0% for bioprostheses at 15 years and 96.7% +/- 1.5% at 12 years for mechanical prostheses). Actual freedom from valve-related morbidity was not different between bioprostheses and mechanical prostheses. Actual freedom from valve-related mortality favored mechanical prostheses in all groups except older than 70 years. CONCLUSION: Comparative evaluation gives high priority in mitral valve replacement for mechanical prostheses relative to bioprostheses for freedom from valve-related reoperation and valve-related mortality but not valve-related morbidity. Freedom from valve-related reoperation and valve-related mortality favors mechanical prostheses for all age groups except older than 70 years. Valve-related morbidity, due to neurologic or functional impairments, does not differentiate between bioprostheses and mechanical prostheses.

Re-operation for bioprosthetic aortic structural failure - risk assessment.

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 Re-op (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=0.00063), for gender was male 4.6% and female 13.3% (P=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=0.00004), for age at explant 'No' 62.6+/-12.7 years and 'Yes' 70.6+/-6.5 years (P=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=0.0011). The predictive risk factor assessment by multivariate regression analysis revealed only NYHA III Odds Ratio 1.7 and IV 7.8 P=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.

Reoperation for bioprosthetic mitral structural failure: risk assessment.

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. CONCLUSIONS: 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.

Carpentier-Edwards supraannular porcine bioprosthesis: second-generation prosthesis in aortic valve replacement.

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.

Hemodynamic comparison of second- and third-generation stented bioprostheses in aortic valve replacement.

BACKGROUND: The hemodynamic performance of aortic replacement prostheses is of extreme importance. There is renewed interest in hemodynamics because of the influence of prosthesis-patient mismatch on left ventricular mass regression and the potential influence on survival. METHODS: The hemodynamic performance of the second-generation Carpentier-Edwards supraannular porcine and pericardial (Perimount) bioprostheses and the third-generation Medtronic Mosaic porcine bioprosthesis were compared for mean gradient and effective orifice area index. The effective orifice area index of at least 0.85 cm2/M2 was considered as lack of prosthesis-patient mismatch. The study group included included 53 patients with Carpentier-Edwards supraannular porcine, 48 with pericardial, and 98 with Medtronic Mosaic porcine bioprostheses. RESULTS: The mean gradients were not different between the prostheses by prosthesis size. The Medtronic Mosaic was not provided in size 19. The mean gradients for the prostheses, except in the very large sizes, were all double-digit values. The effective orifice area index was not different between the prostheses but there was a trend toward prosthesis-patient mismatch in smaller size prostheses. CONCLUSIONS: There was no apparent hemodynamic advantage between porcine and pericardial bioprostheses in the aortic position.

Carpentier-Edwards porcine bioprostheses: clinical performance assessed by actual analysis.

BACKGROUND AND AIM OF THE STUDY: 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. METHODS: 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. RESULTS: 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 the >70 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 the >70 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. CONCLUSION: 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 aged >60 years, and for MVR in patients aged >70 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.

Carpentier-Edwards standard and supraannular porcine bioprostheses: comparison of technology.

BACKGROUND: 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. METHODS: 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. RESULTS: 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 (p<0.05). 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 (p<0.05). 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. CONCLUSIONS: 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.

Carpentier-Edwards supraannular porcine bioprosthesis evaluation over 15 years.

BACKGROUND: The Carpentier-Edwards supraannular porcine bioprosthesis experience during 15 years has been evaluated to determine the incidence of structural valve deterioration by valve position in various age groupings. METHODS: From 1981 to 1995, 2,943 patients older than 20 years had the prosthesis implanted in 3,024 procedures. The mean age of the population was 65.5+/-11.9 years (range, 21 to 89 years). Aortic valve replacement was performed in 1,657 patients (54.8%); mitral valve replacement, 1,092 (36.1%); multiple valve replacement, 253 (8.3%); pulmonary valve replacement, 2 (0.1%); and tricuspid valve replacement, 20 (0.7%). Concomitant procedures were performed in 1,332 patients (45.3%), and 352 (12.0%) had previous procedures. RESULTS: The early mortality was 8.9% (270), only 0.4% (11) valve-related. The total follow-up was 17,471 years (mean, 5.9+/-4.1 years). The late mortality was 5.2%/ patient-year (901) with the valve-related component 1.0%/patient-year (171). The reoperation rate was 2.1%/ patient-year (369) with 4.3% mortality (16). The linearized rate of structural valve deterioration was 2.0%/patient-year (341), and overall complications, 5.9%/patient-year (1,019). The overall survival, at 15 years, was 31.1%+/2.8% (p < 0.05; aortic valve replacement greater than mitral valve replacement or multiple valve replacement). The freedom from structural valve deterioration for aortic valve replacement was, at 12 years, for patients older than 70 years, 95.3%+/-2.7%; 61 to 70 years, 92.9%+/-2.1%; 51 to 60 years, 70.1%+/-5.3%; 41 to 50 years, 60.0%+/-8.8%; and 21 to 40 years, 75.7%+/-7.3%. The freedom from structural valve deterioration for mitral valve replacement was, at 12 years, for patients older than 70 years, 66.1%+/-9.7%; 61 to 70 years, 53.1%+/-4.7%; 51 to 60 years, 52.6%+/-5.5%; 41 to 50 years, 39.3%+/-6.9%; and 21 to 40 years, 42.1%+/-9.4%. CONCLUSIONS: 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 (when extended longevity is not anticipated).

Transcranial magnetic stimulation: use of motor evoked potentials in the evaluation of surgically induced spinal cord ischemia.

We evaluated transcranial magnetic stimulation producing motor evoked potentials (TMS MEP) as a method to detect spinal cord ischemia during surgery for thoracoabdominal aneurysms. Four groups of swine were subjected to different types of surgically-induced ischemia. TMS MEP and neurological function were assessed at baseline, immediately after the ischemic insult and after four hours of reperfusion/post-ligation. Cross-clamping of the aorta in groups A&B resulted in the disappearance and subsequent reappearance of TMS MEP with significantly prolonged latencies in most animals and variable neurological function. Ligation of intercostal arteries produced no changes in TMS MEP or neurological function (group C). However, after ligation of intercostal and lumbar arteries, group D demonstrated no reappearance of TMS MEP and severe neurological deficits. TMS MEP can provide rapid detection of global spinal cord ischemia and can also predict local devascularization injury.

Experimental use of somatosensory evoked potential for intraoperative identification of spinal cord blood supply.

The role of sensory evoked potentials (SEPs) to be used intraoperatively to reliably predict spinal cord ischemia, caused by interruption of intercostal and of lumbar and sacral arteries, was evaluated in a canine model. Two groups were assessed: (A) interruption of intercostal arteries (n = 6) and (B) interruption of all posterior branches (n = 6). SEPs were evaluated intraoperatively as control and interruption of posterior vessel groups, and at 18-22 h after surgery. Neurologic assessment was performed preoperatively and 18-22 h postoperatively by modified Tarlov criteria. Morphological assessments were also performed. The assessment of the groups demonstrated prolongation of latency and loss of amplitude of SEP, but individual changes of SEPs were poor predictors of paraplegia. Ultrastructural changes correlated with neurologic findings. SEPs were unreliable for intraoperative identification of vessels critical to spinal cord blood supply, possibly related to anatomically different blood supply of sensory and motor tracts.

Animal model for investigation of spinal cord injury caused by aortic cross-clamping.

The objective of this experimental protocol was to design a large animal model that could simulate the ischemic condition caused by aortic cross-clamping during the operation for intrathoracic and thoraco-abdominal aneurysm. Domestic swine weighing 25 to 30 kg were used for this model. The thoracic cavity was opened through the fourth intercostal space. Cross-clamp was applied below the left subclavian artery. Duration of cross-clamp was 30 min and the reperfusion period was 24 h. Methods of assessment included Tarlov's criteria, histology transmission electron microscopy, and spinal cord perfusion with microspheres. This model is reproducible. The results of experimental protocols completed using this model are referenced. This article discusses the details of the experimental protocol with steps toward reproduction of the model and rationalization. This animal model can be used for the evaluation of the pathophysiology of spinal cord injury and sensory- and motor-evoked potentials, and most importantly it can also be used for the examination of pharmacological interventions for prevention and treatment of ischemia reperfusion injury caused by aortic cross-clamping.

Spinal cord protection with distal perfusion for thoracic and thoracoabdominal aortic surgery.

Spinal cord protection is of extreme importance to avoid the catastrophic complication of paraplegia related to surgery for thoracic and thoracoabdominal aortic disease.P-' Spinal cord injury from surgi- cally induced ischemia for aortic surgery has a variable risk of paraplegia. The incidence of spinal cord injury varies extensively-aneurysms of the proximal descending thoracic aorta and thoracoabdominal aorta 3% to 35%;to repair of traumatic rupture of the thoracic aorta performed with simple cross-clamping with- out distal perfusion, 25%;to repair of acute type B dissections of the thoracoabdominal aorta, as high as 35%.

Unilateral versus bilateral internal mammary revascularization. Survival and event-free performance.

BACKGROUND: The influence of unilateral (UL) and bilateral (BL) mammary artery revascularization, within age groups < or = 60 years and > 60 years, on patient survival, ischemic-related events, and interventional management was studied in 1142 patients who had coronary artery bypass graft surgery between 1984 and 1992. METHODS AND RESULTS: UL revascularization was performed in 765 (67%) and BL in 377 (33%) patients with supplemental vein grafts. The overall early and hospital mortality rate was 2.7%. For UL in the age group < or = 60 years, it was 1.1%; for BL < or = 60 years, 1.3% (P = NS); for UL > 60 years, 4.3%; and for BL > 60 years, 2.8% (P = NS). Twenty-five preoperative patient characteristics representing demographics, extent of disease, concomitant disease, ventricular dysfunction, previous surgery, and status did not differentiate the patient groups (P = NS). Patient survival at 5 years was not different: 94% for UL < or = 60 years, 95% for BL < or = 60 years, 91% for UL > 60 years, and 86% for BL > 60 years (P = NS). The freedom from ischemic-related events was not different at 5 years (P = NS). The freedom from recurrent angina was 78% for UL < or = 60 years, 88% for BL < or = 60 years, 82% for UL > 60 years, and 83% for BL > 60 years (P = NS). The myocardial infarction freedom was 98% for UL < or = 60 years, 96% for BL < or = 60 years, 99% for UL > 60 years, and 97% for BL > 60 years (P = NS). The freedom from sudden unexpected death and cardiac death did not differentiate the groups (P = NS). The freedom from angioplasty and reoperation did not differentiate the groups (P = NS). The freedom from all ischemic-related and interventional events was 76% for UL < or = 60 years, 84% for BL < or = 60 years, 81% for UL > 60 years, and 79% for BL > 60 years (P = NS). A trend exists for less angina pectoris in the bilateral population < or = 60 years, which reflects in the trend in the freedom from overall events. CONCLUSIONS: UL and BL mammary artery revascularizations have the same early mortality regardless of age but do not reveal any advantage for BL revascularization at 5 to 7 years.

Carpentier-Edwards supraannular porcine bioprosthesis: clinical performance to twelve years.

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 < 0.05). The overall patient survival at 12 years was 44% +/- 3% (p < 0.05, AVR > 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 < 0.05, AVR > MVR > MR). The overall freedom from valve-related reoperation at 12 years was 58% +/- 5% (p < 0.05, AVR > MVR, MR), and from valve-related mortality 89% +/- 2% (p < 0.05, AVR > MVR > MR). The freedom from residual morbidity (permanent impairment) at 12 years was 87% +/- 4% (p = not significant by valve position).(ABSTRACT TRUNCATED AT 250 WORDS)

Structural deterioration in Carpentier-Edwards standard and supraannular porcine bioprostheses.

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 (p < 0.05). 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)

Additive effect of allopurinol and deferoxamine in the prevention of spinal cord injury caused by aortic crossclamping.

Fourteen domestic swine were divided into two groups. Group A (n = 7) was the control group, in which no pharmacologic intervention was applied. In group B (n = 7), the ischemic-reperfused spinal cord was treated with the combination of allopurinol (50 mg/kg/day for 3 days before the day of operation) and deferoxamine (Desferal, 50 mg/kg administered intravenously over 3 to 4 hours). The administration of deferoxamine was completed 1 hour before crossclamping. The crossclamp was placed on the descending aorta just distal to the left subclavian artery for 30 minutes. Proximal hypertension was controlled with sodium nitroprusside and volume depletion. Methods of assessment included an evaluation of the neurologic status of the animals by quantitative Tarlov criteria, blood flow by radiolabeled microspheres, and histologic examination of the spinal cord. All animals in the control group, group A, were completely paraplegic with 0% recovery by Tarlov criteria at 24 hours after the removal of the crossclamp. In contrast, all animals in group B, in which the combination of allopurinol and deferoxamine was used, completely recovered (100% recovery by Tarlov criteria), and at 24 hours after the ischemic episode they were able to walk with no difficulty and had intact sensation. Functional parameters of these animals fully correlated with the morphologic findings. Widespread acute neuronal injury and vacuolation of neuropil were observed in the control group of animals. In contrast, animals in group B showed much less pronounced morphologic changes after the same period of ischemia. In summary, the combined use of these agents significantly (p < 0.001) reduced the incidence of paraplegia induced by aortic crossclamping with 82% additivity.

Experience with thoracoabdominal aortic aneurysm resection.

From 1984 to 1993, 48 thoracoabdominal aortic aneurysm resections were performed. The patient age ranged from 21 to 79 years (mean: 65.5 years), and the extent of the aneurysms were as follows: type I (most of descending and upper abdominal), 17 cases; type II (most of descending and most of abdominal), 3 cases; type III (distal descending and upper abdominal), 20 cases; and type IV (most or the entire abdominal aorta), 8 cases. Ten patients presented with ruptured aneurysms, 1 with hemoptysis, 20 with pain, and 20 with no symptoms. Operation was performed using simple aortic cross-clamping in 18 patients, distal perfusion via Gott shunt in 6, and heparinless left-heart bypass (Biomedicus pump) in 24. Intercostal or lumbar vessels were reimplanted into the graft in 13 patients. Aortic cross-clamp time was 25 to 115 minutes (mean: 49.6 minutes). Four of 10 patients (40%) with ruptured aneurysms and 3 of 38 (8%) patients with non-ruptured aneurysms died. Serious complications included paraparesis in 2 patients (5%), renal failure requiring dialysis in 2 (5%), stroke in 1 (2%), bleeding in 5 (12%), intraoperative cardiac arrest in 3 (7%), sepsis in 1 (2%), prolonged ventilation (longer than 3 days) in 11 (27%), and wound dehiscence in 2 (5%). Thoracoabdominal aneurysm resection remains a challenging problem but can be performed with acceptable risk in selected patients. Distal heparinless perfusion without a heat exchanger may help reduce the risk of paraplegia and renal failure.

Structural valve deterioration in elderly patient populations with the Carpentier-Edwards standard and supra-annular porcine bioprostheses: a comparative study.

From 1975 to 1989, over 1400 patients in the elderly population and over 1700 patients under 65 years of age received the Carpentier-Edwards standard (CE-Standard) and supra-annular porcine (CE-SAV) bioprotheses. The mean ages of the patients receiving the two protheses within the three subgroups of the elderly population-65-69 years, 70-79 years, and 80 years and over-were relatively similar. There was no statistically significant difference in the performance of the prostheses regarding structural valve deterioration (SVD) at seven years. The freedom from SVD for aortic valve replacement in the 65-69 years group at seven years was 98.7% +/- 1.3% for the CE-Standard and 98.7% +/- 1.0% for the CE-SAV, for both the 70-79 years group and the 80 years and over group the figure was 100% for both prostheses (p = NS). The freedom from SVD after mitral valve replacement in the 65-69 years group at seven years was 90.0% +/- 4.3% for the CE-Standard and 84.8% +/- 7.5% for the CE-SAV, for the 70-79 years group it was 95.3% +/- 3.2% and 95.5% +/- 3.6% respectively and for the 80 years and over group the figure was 100% for both prostheses (p = NS within groups). The long term freedom from SVD after aortic valve replacement was 98.4% +/- 3% at 15 years for the CE-Standard in the 65-69 years group, 94.9% +/- 5% at 13 years for the 70-79 years group and 100% at 13 years for the 80 years and over group.(ABSTRACT TRUNCATED AT 250 WORDS)