Alfred N. Gerein

Carpentier-Edwards standard porcine bioprosthesis: primary tissue failure (structural valve deterioration) by age groups

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)

Cardiac valve replacement in the elderly: Clinical performance of biological prostheses

From 1975 to 1987, 1,127 elderly patients underwent 1,223 valve replacements with the Carpentier-Edwards standard or supraannular porcine bioprostheses in 1,147 operations. Of the total patient population seen during these years, 33.5% receiving a standard porcine bioprosthesis and 48.6% receiving a supraannular bioprosthesis were 65 years of age or older. Of this elderly patient population, 465 patients were between 65 and 69 years old; 618 patients, 70 and 79 years old; and 52 patients, 80 years old and older. Aortic valve replacement was performed in 635 patients, mitral valve replacement in 417 patients, tricuspid valve replacement in 2 patients, and multiple-valve replacement in 80 patients. The cumulative follow-up was 3,957 patient-years. Early mortality was 9.5%: 7.3% for the 65- to 69-year-old group, 10.7% for the 70- to 79-year-old group, and 15.4% for the group 80 years old and older. Late mortality was 5.5% per patient-year: 4.2% per patient-year for the 65- to 69-year-old group, 6.3% per patient-year for the 70- to 79-year-old group, and 14.1% per patient-year for the group 80 years old and older. Valve-related causes contributed to 7 early deaths and 33 late deaths. The overall patient survival, including operative deaths, was 70.7% +/- 1.6% at 5 years and 47.8% +/- 3.7% at 10 and 12 years. The freedom from all valve-related complications was 52.1% +/- 6.1% at 10 and 12 years. The overall rate of valve-related complications was 5.0% per patient-year (fatal complications, 1.13% per patient-year). The overall rate of thromboembolism was 2.3% per patient-year and the freedom from thromboembolism, 69.6% +/- 5.2% at 10 and 12 years. The freedom from structural valve deterioration was 80.8% +/- 8.1% at 10 and 12 years: 71.7% +/- 11.0% at 10 and 12 years for the 65- to 69-year-old group, 97.9% +/- 1.2% at 10 years for the 70- to 79-year-old group, and 100% at 12 years for the group 80 years old and older. At 10 and 12 years, the freedom from valve-related death was 83.7% +/- 4.3% and the freedom from reoperation, 73.3% +/- 8.6%. The freedom from valve-related death, residual morbidity from thromboembolism and anticoagulant-related hemorrhage, and reoperation was 61.7% +/- 7.0% at 10 and 12 years. The clinical performance of porcine bioprostheses in the elderly patient population has been excellent. The early mortality increases in patients 70 years old or older.(ABSTRACT TRUNCATED AT 400 WORDS)

Surgical Management of Spontaneous Pneumothorax in Patients with Acquired Immunodeficiency Syndrome

Spontaneous pneumothorax has been reported with increasing frequency in patients with acquired immunodeficiency syndrome and Pneumocystis carinii pneumonia. In the past year, we treated 4 patients with spontaneous pneumothorax. All of them were treated with closed tube thoracostomy, and 1 patient with bilateral apical cysts eventually required bilateral thoracotomies and pleurectomies. Only 1 patient had an uncomplicated hospital course. The remaining patients had prolonged air leaks, and 2 had synchronous pneumothoraces. Pneumothorax appears to be associated with P. carinii pneumonia. We recommend closed tube thoracostomy as the initial treatment in symptomatic patients. Pleurectomy for air leaks persisting longer than seven days can be safely performed in patients fit for thoractomy.

Experience with the Carpentier-Edwards Porcine Valve Prosthesis in 700 Patients

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.

Mitroflow pericardial bioprosthesis: Clinical performance to ten years

The Mitroflow pericardial bioprothesis, a second generation pericardial prosthesis, has clinical performance assessment to 10 years. This bioprosthesis was used in 445 operations in 445 patients between 1982 and 1992 inclusive (mean age, 59.1 years; age range, 19 to 94 years). There were 253 aortic valve replacements (AVR), 155 mitral valve replacements (MVR), 31 multiple valve replacements (MR), and 6 tricuspid valve replacements. Concomitant procedures were performed in 40 patients (14.2%). The age group distributions (years) were less than or equal to 35 years, 28 patients; 36 to 50 years, 79; 51 to 64 years, 167; 65 to 69 years, 70; and 70 years or more, 101 patients. The total follow-up was 1,524 patient-years (mean, 5.4 years), 96% complete. The early mortality was 6.3%/patient-year (28 patients) and the late mortality was 4.1%/patient-year (96 patients). Concomitant procedures did not influence either early or late mortality (p = not significant [NS]). The overall patient survival at 10 years was 58% +/- 5% (p = NS by valve position). The overall freedom from structural valve deterioration (SVD) at 8 years was 69% +/- 3% and at 10 years, 45% +/- 7%; and at 8 years AVR 80% +/- 4%, MVR 58% +/- 6%, and MR 38% +/- 11% (p < 0.05, AVR > MVR > MR). The freedom from thromboembolism (TE) was 87% +/- 2%, overall at 10 years, and was not different by valve position (p = NS).(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.

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.

The mitral medical pericardial bioprosthesis: new generation bovine pericardial prosthesis.

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 bloprosthesis has provided very satisfactory clinical performance and afforded patients excellent quality of life.