MacNab J

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.

Predictors of recurrence and reoperation for prosthetic valve endocarditis after valve replacement surgery for native valve endocarditis.

OBJECTIVE Surgical treatment of native valve endocarditis remains challenging, especially in cases with paravalvular destruction. Basic principles include complete debridement and reconstruction. This study is designed to evaluate the outcomes of surgical reconstruction of complex annular endocarditis using standard techniques and materials, including autologous and bovine pericardium. METHODS From 1975 to 2000, 358 cases (357 patients, mean age 49 +/- 16 years, range 18-88 years) of native valve endocarditis were surgically managed. Bioprosthetic valves were implanted in 189 cases, and mechanical prostheses were implanted in 169 cases. A total of 78 cases of paravalvular destruction were identified: 62 annular abscesses, 8 fistulas, and 8 combined abscesses/fistulas. These were managed with 46 pericardial patches and 32 isolated suture reconstructions after radical debridement and prosthetic valve replacement. RESULTS The overall early mortality was 8.4% (n = 30). The mortality with paravalvular destruction was 17.9%, and the mortality with simple leaflet infection was 5.7% (P = .001). The unadjusted survival at 20 years was 26.4% +/- 4.9% for bioprosthetic valves and 56.5% +/- 8.1% for mechanical prostheses (P = .007). The freedom from recurrent prosthetic valve endocarditis was 78.9% +/- 4.4% at 15 years. The freedom from reoperation for recurrent prosthetic valve endocarditis was 85.8% +/- 4.2% at 15 years. The freedom from reoperation after reconstruction for paravalvular destruction was 88.2% +/- 6.9% at 15 years. The freedom from mortality for recurrent prosthetic valve endocarditis was 92.7% +/- 3.4% at 15 years. The independent predictors of reoperation were age (hazard ratio 0.930, P = .005) and intravenous drug use/human immunodeficiency virus plus surgical technique (hazard ratio 12.8, P = .003 for patch reconstruction plus valve and hazard ratio 3.6, P = .038 for valve replacement only). Prosthesis type was not predictive when separated from intravenous drug use/human immunodeficiency virus (hazard ratio 3.268, P = .088). CONCLUSION Paravalvular destruction is associated with a higher operative mortality. Native valve endocarditis can be managed with reasonable long-term survival and low rates of reinfection with radical debridement and pericardial reconstruction with bioprostheses and mechanical prostheses. The type of prosthesis implanted does not influence long-term outcome. Patients with a history of intravenous drug use and human immunodeficiency virus are at increased risk for recurrent infection and reoperation.

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)

The Carpentier-Edwards Standard Porcine Bioprosthesis: Clinical Performance to 15 Years

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 thromboemboiism 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 < 0.05, AVR > MR > MVR). The freedom from structural valve deterioration at 15 years was 71% for AVR, 41% for MVR, and 41% for MR (14 years) (p < 0.05, AVR > MVR > 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 < 0.05, AVR > MVR > 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 < 0.05, AVR > MR > MVR). The freedom from all complications at 14 years was 50% for AVR, 25% for MVR, and 27% for MR (p < 0.05, AVR > MR > MVR). The Carpentier‐Edwards standard porcine bloprosthesis has provided satisfactory clinical performance in a valve replacement population essentially receiving only biological prostheses.

The Carpentier-Edwards supra-annular porcine bioprosthesis: clinical performance to 8 years of a new generation porcine bioprosthesis.

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 < 0.05, AVR > MR > MVR). The freedom from structural valve deterioration was 86% for AVR, 73% for MVR, and 96% for MR at 8 years (p < 0.05, AVR > MR > 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 < 0.05, AVR > MR > 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 < 0.05, AVR > MVR > MR). The freedom from all valve‐related complications at 8 years was 74% for AVR, 54% for MVR, and 78% for MR (p < 0.05, AVR > MVR > MR). The Carpentier‐Edwards supra‐annular porcine bioprosthesis provides clinical performance characteristics similar to first generation porcine bioprostheses.

Seven-year results with the St Jude Medical Silzone mechanical prosthesis

OBJECTIVE The Artificial Valve Endocarditis Reduction Trial was stopped on January 21, 2000, due to a higher incidence of paraprosthetic leak in the St Jude Medical Silzone prosthesis compared with the conventional prosthesis. The Artificial Valve Endocarditis Reduction Trial investigators reported the 2-year results in 2002. This retrospective study assessed the influence on thromboembolism and paraprosthetic leak to 7 years. METHODS A total of 253 patients had 254 operations: 80 aortic valve replacements, 139 mitral valve replacements, and 35 multiple replacements with placement of Silzone prostheses. The mean age was 58.6 years (range 21-84 years, median age 59.8 years), and there were 126 women (49.8%) and 74 concomitant procedures (coronary artery bypass 28.9%). RESULTS Major paraprosthetic leak (repair, re-replacement, or mortality) occurred in 10 of the original procedures after 30 days (3 aortic valve replacements, 3 mitral valve replacements, 4 multiple replacements). Nine occurrences in 8 patients-5 early (<or=2 years) and 4 late (>2 years)-were managed. Seven were managed with definitive re-replacement. One was an early nonoperative fatality. There was 1 late fatality after the second late paraprosthetic leak reoperation. One of the 10 procedures occurring after 2 years had mild to moderate aortic valve replacement paraprosthetic leak managed as an incidental re-replacement at the time of correction of supra valvular patch stenosis. One additional occurrence, in addition to the 8 patients (<30 days), was considered a technical error and not related to the Silzone prosthesis and was replaced with a Silzone prosthesis. The linearized rate of paraprosthetic leak within the first 2 years of follow-up was 1.3%/patient-year and after 2 years was 0.4%/patient-year. The linearized occurrence rate for major thromboembolism was 0.42%/patient-year for aortic valve replacement and 1.71%/patient-year for mitral valve replacement. CONCLUSIONS Paraprosthetic leak with the St Jude Medical Silzone prosthesis was managed both during the early (<or=2 years) and late (>2years) intervals with re-replacement. Late managed events may be manifestations of earlier occurring paraprosthetic leak. Follow-up echocardiograms should meet standards of care, 6 to 12 months after surgery and at the slightest suspicion of dysfunction. There is no advanced continuing risk of the St Jude Medical Silzone prosthesis.

The Carpentier-Edwards Supra-Annular Porcine Bioprosthesis: New Generation Low Pressure Glutaraldehyde Fixed Prosthesis

Abstract 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.

The Carpentier-Edwards standard porcine bioprosthesis: long-term evaluation of the high pressure glutaraldehyde fixed prosthesis.

The Carpentier‐Edwards standard porcine bloprosthesis 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 func-tional Class III and IV, preoperatively and 93.1% Class 1 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.