Biomedical subjects

G J Fradet

Publications and source records attributed to G J Fradet.

14 recordsLinked to original sources

PubMed2006

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.

Adolescent↗

PubMed2005

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.

Adult↗

PubMed2003

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.

Adult↗

PubMed2003

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.

Adult↗

PubMed2001

Mosaic valve international clinical trial: early performance results.

BACKGROUND: A new third generation porcine bioprosthesis was developed in an attempt to improve on hemodynamic performance and durability of current prostheses. METHODS: One thousand, two hundred, sixty patients underwent aortic valve replacement and 366 patients underwent mitral valve replacement between February 1994 and September 2000. The cumulative follow-up was 3,696.3 patient-years for aortic valve replacement and 880.1 patient-years for mitral valve replacement. Follow-up was complete for 95.5% of aortic valve replacement patients and 97.5% of mitral valve replacement patients. RESULTS: For aortic valve replacement, freedom from valve-related adverse events at 1 year was 96.5%+/-0.5% for antithromboembolic-related hemorrhage and 100% for structural valve deterioration. Freedom from valve-related adverse events at 5 years was 93.8%+/-2.6% for antithromboembolic-related hemorrhage and 99.3%+/-0.9% for structural valve deterioration. For mitral valve replacement, freedom from valve-related adverse events at 1 year was 96.0%+/-1.1% for antithromboembolic-related hemorrhage and 100% for structural valve deterioration. Freedom from valve-related adverse events at 4 years was 92.1%+/-3.7% for antithromboembolic-related hemorrhage and 100% for structural valve deterioration. CONCLUSIONS: These results support the claim that the Mosaic bioprosthetic valve is efficacious and safe, but continued follow-up is mandatory to determine mid- and long-term performance.

Adult↗

PubMed2000

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.

Actuarial Analysis↗

PubMed2000

CarboMedics mechanical prosthesis: performance at eight years.

BACKGROUND AND AIM OF THE STUDY: The bileaflet St. Jude Medical mechanical prosthesis has been implanted for over 20 years. The purpose of this study was to evaluate the clinical performance of the bileaflet CarboMedics (CM) prosthesis, which was introduced in 1986. METHODS: The CM prosthesis was implanted in 1,258 patients (709 males, 549 females; mean age 60.9 +/- 12.3 years) between 1989 and 1997. The prosthesis distribution was aortic valve replacement (AVR) 613; mitral valve replacement (MVR) 447; and multiple replacement (MR) 231. Coronary artery bypass (CAB) was performed in 334 (26.6%) patients; previous procedures had been performed in 346 (27.5%). The age distribution was <60 years (n = 527), 61-70 years (n = 424) and >70 years (n = 307). Risk factors assessed were age or age groups, gender, CAB, previous surgery, rhythm, valve position, status and NYHA functional class. The total follow up was 4,765.0 patient-years (pt-yr), and was 98.4% complete. RESULTS: The early mortality rate was 5.6% (AVR 4.8%, MVR 3.7%, MR 11.5%). The late mortality rate was 3.7%/pt-yr (n = 174), and valve-related mortality 1.1%/pt-yr (n = 50). The total thromboembolism (TE) rate was 4.1%/pt-yr (n = 195) (p = NS by valve position); the major TE rate was 1.9%/pt-yr and fatal TE rate 0.31%/pt-yr (n = 15). The valve thrombosis rate was 0.31%/pt-yr (n = 15; 11 MVR, four MR). The fatal thrombosis rate was 0.06%/pt-yr (n = 3; two MVR, one MR). The hemorrhage rate was 2.7%/pt-yr (n = 128) and fatal hemorrhage rate 0.4%/pt-yr (n = 20). The reoperation rate was 1.0%/pt-yr (n = 46), fatal 0.1%/pt-yr (n = 5). The actuarial freedom from overall TE at eight years was 77.3 +/- 2.8%; major TE 88.5 +/- 1.6%, and hemorrhage 76.4 +/- 3.2% (all p = NS by valve position). There were no independent predictors of overall TE and TE exclusion of early events. The only predictor for TE major was status (emergency > urgent > elective). The actuarial freedom from valve-related mortality at eight years was 91.4 +/- 1.8% (p = NS by position) (actual freedom 93.0 +/- 1.3%). The actuarial freedom from valve-related reoperation was 91.1 +/- 2.4% (p <0.05; AVR > MVR and MR, MVR > MR) (actual freedom 92.2 +/- 2.7%). Overall survival rate at eight years was 68.2 +/- 2.3% (p <0.05; AVR > MVR and MR, MVR > MR). CONCLUSION: The clinical performance of the CarboMedics mechanical prosthesis is satisfactory when implanted in the mitral, aortic and multiple positions.

Aged↗

PubMed1999

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.

Adult↗

PubMed1999

Bileaflet mechanical prostheses performance in mitral position.

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; P = NS). The linearized rate of total TE events for overall MVR was 5.0%/patient-year (CM 4.4; SJM 5.4). The < or = 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 < or = 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.

Adult↗

PubMed1998

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).

Adult↗

PubMed1995

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)

Adolescent↗

PubMed1995

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)

Adolescent↗

PubMed1995

Clinical performance of biological and mechanical prostheses.

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 (p < 0.05). The relationship existed for major thromboembolism and hemorrhage, 91% (CE-S), 87% (CE-SAV), and 88% (mechanical) (p < 0.05), without clinical relevance. The freedom from structural valve deterioration and valve-related reoperation favored mechanical prostheses (p < 0.05) 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 (p < 0.05) 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 (p < 0.05) but not clinically relevant.(ABSTRACT TRUNCATED AT 250 WORDS)

Actuarial Analysis↗

PubMed1994

Anterior and middle mediastinum paraganglioma: complete resection is the treatment of choice.

Paraganglioma of the mediastinum is described to be an indolent and slow-growing tumor. After a patient presented to our center, we reviewed the world literature to evaluate the prognosis of this tumor. This review showed that paragangliomas are locally invasive and have a high local recurrence rate (44/79 or 55.7%) with a true metastatic capacity (21/79 or 26.6%). The overall survival is 62.0% (49/79), but only 36.7% (29/79) of patients could be considered as free of disease, with survival time of 98.2 +/- 11.7 months (mean +/- standard error). The survival with a complete resection is 84.6% (125.7 +/- 18.7 months) versus 50.0% (71.5 +/- 13.8 months) for patients with a biopsy or a partial excision and adjuvant treatment (p < 0.01). We acknowledge the limitation of this retrospective study, but a prospective trial is not possible because of the rarity of the tumor. We want to emphasize that paraganglioma of the anterior and middle mediastinum is an aggressive tumor, and complete surgical resection, using cardiopulmonary bypass if necessary, is highly recommended.

Aged↗