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Biomedical subjects

M T Janusz

Publications and source records attributed to M T Janusz.

At least 37 records · Page 2Linked to original sources
PubMed1992

Pharmacologic interventions for prevention of spinal cord injury caused by aortic crossclamping.

The efficacy of pharmacologic agents for prevention and control of oxygen-derived free radical damage in ischemia-reperfusion injury of the spinal cord was assessed in a swine model of thoracic and thoracoabdominal aortic crossclamping. Animals were exposed to 30 minutes of ischemia that induced lethal, irreversible injury and paraplegia. The experimental groups were as follows: group A (n = 7), control group, receiving no pharmacologic intervention; group B (n = 7), deferoxamine 50 mg/kg/day administered intravenously over 3 to 4 hours before ischemia; group C (n = 7), allopurinol pretreatment 50 mg/kg/day for 3 days; and group D (n = 7), superoxide dismutase 60,000 units administered with 50,000 units before removal of the aortic crossclamp and 10,000 units over 10 minutes of reperfusion. Proximal hypertension was controlled with sodium nitroprusside and volume depletion. The methods of assessment were neurologic by a modified Tarlov criteria and blood flow by radiolabeled microspheres. Results of blood flow assessment confirmed a true ischemic episode of 30 minutes for all animals in all groups. The blood flow fell significantly during ischemia (p less than 0.01) and a hyperemic response was evident in the early reperfusion period. All animals in control group A were paraplegic. The group B (deferoxamine) results were superior; 85% had grade III function on a modified Tarlov scale, with animals in the group standing and even walking with difficulty. Only one animal in this group had good movements of hind limbs but was unable to stand or walk. Neurologic recovery was limited in the allopurinol group (group C), with 85% showing slight neurologic recovery with limited movement of the hind limbs. The animals in the superoxide dismutase group (group D) all had good recovery, with strong motor response of hind limbs, but were not able to stand. In summary, the results of this experimental protocol confirmed the possible role of oxygen-derived free radicals in the pathophysiology of spinal cord injury, induced by aortic crossclamping. Moreover, it proved that ischemia-reperfusion injury could be altered by pharmacologic interventions.

Allopurinol↗
PubMed1992

Cardiopulmonary bypass for resuscitation of patients with accidental hypothermia and cardiac arrest.

Hypothermic patients have been successfully rewarmed by a number of methods. However, when cardiac arrest occurs, as it frequently does at core temperatures of less than 27 degrees C, prolonged cardiopulmonary resuscitation (CPR) is required, because defibrillation can rarely be achieved until the patient has been rewarmed to 30 degrees to 34 degrees C. Five cases of accidental hypothermia with cardiac arrest treated with cardiopulmonary bypass are discussed. The first patient died as a result of inadequate low-flow cardiopulmonary bypass by the femorofemoral route. The second patient had prolonged CPR by closed-chest cardiac massage and warm peritoneal lavage followed by transthoracic cardiopulmonary bypass. This patient regained consciousness but was found to be paraplegic and died from bowel infarction related to peritoneal rewarming without adequate perfusion. In the last three patients, high-flow cardiopulmonary bypass was rapidly achieved using a no. 28 French chest tube for femoral venous cannulation, and they recovered completely. In cases of accidental hypothermia with cardiac arrest, rapid institution of full cardiopulmonary bypass provides excellent circulatory support and rapid rewarming. This avoids the complications of prolonged inadequate circulation that occur when closed-chest cardiac massage and external rewarming are used.

Adult↗
PubMed1991

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 thromboembolism and antithromboembolic therapy-related hemorrhage at 15 years was 79.5% for aortic valve replacement (AVR), 72% for mitral valve replacement (MVR), and 84% for multiple valve replacement (MR) (p less than 0.05, AVR greater than MR greater than MVR). The freedom from structural valve deterioration at 15 years was 71% for AVR, 41% for MVR, and 41% for MR (14 years) (p less than 0.05, AVR greater than MVR greater than MR). The freedom from nonstructural dysfunction and prosthetic valve endocarditis did not distinguish the valve positions (p = NS). The freedom from valve-related mortality from all causes including reoperation was 92% for AVR, 78% for MVR, and 77% for MR at 15 years (p less than 0.05, AVR greater than MVR greater than MR). The freedom from residual morbidity was not significantly different between valve positions (p = NS). The freedom from treatment failure (valve-related mortality and residual morbidity) at 15 years was 87% for AVR, 72% for MVR, and 75% for MR (p less than 0.05, AVR greater than MR greater than MVR). The freedom from all complications at 14 years was 50% for AVR, 25% for MVR, and 27% for MR (p less than 0.05, AVR greater than MR greater than MVR).(ABSTRACT TRUNCATED AT 250 WORDS)

Adolescent↗
PubMed1991

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 less than 0.05, AVR greater than MR greater than MVR). The freedom from structural valve deterioration was 86% for AVR, 73% for MVR, and 96% for MR at 8 years (p less than 0.05, AVR greater than MR greater than MVR). The freedom from nonstructural valve dysfunction and prosthetic valve endocarditis was not different between positions (p = NS). The freedom from valve-related mortality at 8 years was 98% for AVR, 94% for MVR, and 98% for MR (p less than 0.05, AVR greater than MR greater than MVR). The freedom from residual morbidity was not different at 8 years (p = NS). The freedom from treatment failure (valve-related mortality and residual morbidity) was 96% for AVR, 89% for MVR, and 94% for MR (p less than 0.05, AVR greater than MVR greater than MR).(ABSTRACT TRUNCATED AT 250 WORDS)

Adolescent↗
PubMed1991

Carpentier-Edwards porcine bioprostheses. Comparison of standard and supra-annular prostheses at 7 years.

The performance of the Carpentier-Edwards supra-annular (CE-SAV) porcine bioprosthesis is compared with the Carpentier-Edwards standard (CE-S) porcine bioprosthesis at 7 years. The standard prosthesis was implanted in 1,195 patients between 1975 and 1987, while the supra-annular prosthesis was implanted in 1,956 patients between 1982 and 1989. The total follow-up for the standard prosthesis was 8,850 patient-years with a mean follow-up of 7.4 years, while for the supra-annular prosthesis it was 7,317 years with a mean of 3.7 years. The follow-up for the standard prosthesis was 96.7% and for the supra-annular prosthesis was 97.6%. The freedom from structural valve deterioration (SVD) for aortic replacements is 96.1 +/- 0.9% for CE-S and 97.6 +/- 1.4% for CE-SAV at 7 years (p = NS). The freedom for mitral replacements from SVD is 89.1 +/- 1.7% and 88.6 +/- 2.8%, respectively, for CE-S and CE-SAV (p = NS). The freedom for multiple replacements at 7 years was 80.0 +/- 4.5% for CE-S and 97.8 +/- 1.5% for CE-SAV (p less than or equal to 0.05). The freedom from SVD for the age group equal to or less than 35 years is 79.0 +/- 4.7% for CE-S and 85.0 +/- 9.4% for CE-SAV (p = NS). The freedom for the age group 36-50 years is 85.2 +/- 2.8% and 90.4 +/- 4.5%, respectively, at seven years for the CE-S and CE-SAV prostheses (p = NS).(ABSTRACT TRUNCATED AT 250 WORDS)

Actuarial Analysis↗
PubMed1991

Traumatic rupture of the thoracic aorta. A 20-year review: 1969-1989.

Acute traumatic injury of the thoracic aorta is a relatively common injury of deceleration accidents, usually high-speed motor vehicle accidents. The limiting factor to successful hospital management of these victims is early diagnosis and prompt treatment. Between the years 1969 and 1989, 116 patients (87 men and 29 women) were diagnosed with acute traumatic injury of the aorta. The mean age was 38.8 years, and the range was from 11 to 82 years. All patients who presented to the hospital emergency departments were included in the evaluation. The diagnosis of aortic rupture was firmly established by either aortography, surgery, or autopsy. The site of injury in 105 (90.5%) was the aortic isthmus, that is, distal to the origin of the left subclavian artery. In nine patients (7.7%) the injury was in the distal thoracic aorta. Two patients had injuries of the aortic arch. Associated injuries were present in 110 patients (95%); 16 patients (14%) had no external evidence of chest injury. Only 50 patients (43%) had the opportunity for definitive surgical management. The nonsurgical group comprised 66 patients (57%), and all of these died; the cause of death was unsuspected, suspected, or diagnosed after hospital admission from the emergency department. Of the surgical group, 36 patients (72%) survived, whereas 14 patients (28%) died. The surgical management comprised partial cardiopulmonary bypass in 31 patients that included seven deaths, simple aortic cross-clamping in 14 that included six deaths, and nonheparinized bypass in four that included one death. The incidence of paraplegia was 3.2% (one patient) with cardiopulmonary bypass, 28.5% (four patients) with simple aortic cross-clamping and none with nonheparinized bypass.(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗
PubMed1991

Age as a determinant for selection of porcine bioprostheses for cardiac valve replacement: experience with Carpentier-Edwards standard bioprosthesis.

Almost exclusive use of Carpentier-Edwards porcine bioprostheses for cardiac valve replacement in 1194 patients between 1975 and 1987 at the authors' institutions has afforded the opportunity for a more scientific basis for prosthesis selection for subsets of patients, with regard to age and valve-related complications. The present study, performed according to previously established guidelines, investigated the influence of patient age and valve position as determinants of durability of 1315 porcine implants in terms of the following valve-related complications: structural valve deterioration, nonstructural dysfunction, thromboembolism, antithromboembolic therapy-related hemorrhage and prosthetic valve endocarditis. Age groups were as follows: 35 years and younger, 36 to 50 years, 51 to 65 years, and 66 years or older. Thromboembolism was found to be less common in the younger age groups, and significantly less common in patients following aortic compared to mitral valve replacement. The age group assessment for antithromboembolic therapy-related hemorrhage, nonstructural dysfunction and prosthetic valve endocarditis revealed no difference between positions or age groups. Patient age was found to be the major predictor of, and inversely related to, structural valve deterioration. In addition, porcine bioprostheses in the aortic position were shown to have durability superior to that of similar valves in the mitral position. Structural valve deterioration has very little influence on valve-related mortality and residual morbidity. This study thus supports the implantation of porcine bioprostheses in somewhat younger patients than would be advisable for mitral prostheses. The authors now recommend the selective implantation of porcine bioprostheses in the aortic position in patients over 65 years of age, and in the mitral position in patients over 70 years of age.

Adolescent↗
PubMed1990

Aortic dissection: current expectations and treatment. Experience with 258 patients over 20 years.

Aortic dissection, the most common acute disease of the thoracic aorta, is associated with high mortality and morbidity. The authors reviewed their experience over the last 20 years with 258 patients who had aortic dissection (259 dissections). The diagnosis was made at autopsy in 69 (27%) patients (59 type A, 10 type B). Of the remainder, 97 patients had type A dissection (78 acute, 19 chronic) and 93 had type B dissection (56 acute, 37 chronic). The sudden onset of severe, unremitting chest pain associated with hyper- or hypotension or a history of hypertension are suggestive of acute aortic dissection. The diagnosis should be followed by prompt investigation and treatment. The 30-day survival rate for patients with type A dissection who underwent surgical treatment was 62%; survival rates for patients with type B dissection, acute and chronic, were 70% and 86% respectively with pharmacotherapy and 66% and 91% with surgery. The authors stress the importance of early, accurate diagnosis and immediate surgical treatment for all patients who have type A dissection and complicated or unresponsive (carefully monitored pharmacologic control of blood pressure) type B dissection.

Adult↗
PubMed1988

Aortic dissection. A six year experience with 117 patients.

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

Acute Disease↗
PubMed1988

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)

Adult↗
PubMed1988

The Carpentier-Edwards supra-annular porcine bioprosthesis: new generation low pressure glutaraldehyde fixed prosthesis.

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.

Adolescent↗
PubMed1988

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

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

Adolescent↗
PubMed1988

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

Adult↗
PubMed1988

The Carpentier-Edwards supraannular porcine bioprosthesis. A new generation tissue valve with excellent intermediate clinical performance.

The Carpentier-Edwards supraannular porcine bioprosthesis, an investigational valve, was implanted in 1167 patients (1174 operations, 1274 valves) between November 1981 and December 1985 (age range 13 to 85 years, mean 61 years). The early mortality rate was 7.2% (with concomitant procedures 10.9%, without 4.8%; with previous operation 10.5%, without 6.6%). The late mortality rate was 4.5% per patient-year (aortic valve replacement, 4.0%; mitral valve replacement, 4.8%; multiple valve replacement, 5.6%). Total cumulative follow-up was 2272.3 years. The prevalence of thromboembolism was 2.6% per patient-year (fatal 0.4% per patient-year, major 1.4%, minor 1.2%); hemorrhage related to antithromboembolic therapy, 0.7% (fatal 0.1%); prosthetic valve endocarditis, 0.4% (fatal 0.2%); periprosthetic leak, 0.4% (fatal 0%); structural valve deterioration (primary tissue failure/structural failure), 0.1% per patient-year; and clinical valve dysfunction, 0.4%. The reoperation rate was 0.8% per patient-year (thromboembolism, 0.1%; clinical valve dysfunction, 0.1%; prosthetic valve endocarditis, 0.1%; periprosthetic leak, 0.4%; structural valve deterioration, 0.1%). Thromboembolism occurred throughout the observation period but with decreasing frequency, hemorrhage throughout the period in no predictable fashion, prosthetic valve endocarditis within 2 years, periprosthetic leak within 2 years, and structural valve deterioration occurred during the fourth year of assessment. The overall survival rate was 79.8% +/- 1.7% (4 years). Freedom (at 4 years) from thromboembolism was 92.2% +/- 1.2%; from structural valve deterioration, 98.8% +/- 0.8%; and from reoperation, 95.8% +/- 1.3%. Freedom from all complications (4 years) was 85.9% +/- 1.7%; from complication mortality, 98.4% +/- 0.4%; and from valve failure (mortality and reoperation), 94.3% +/- 1.3%. This investigational Carpentier-Edwards supraannular porcine bioprosthetic valve has provided excellent clinical performance and remains our overall prosthesis of choice.

Aged↗
PubMed1988

Carpentier-Edwards porcine bioprostheses: assessment of clinical performance.

Carpentier-Edwards porcine bioprostheses have been implanted since 1975, commencing with the previous generation standard prosthesis in that year and the new generation supra-annular prosthesis in 1981. The first 700 operations with each prosthesis were evaluated: Carpentier-Edwards standard porcine bioprosthesis (CE-S), 692 patients (772 valves) and Carpentier-Edwards supra-annular porcine bioprosthesis (CE-SA), 698 patients (756 valves). The incidence of thromboembolism was CE-S 1.4% per patient-year and CE-SA 2.1% per patient-year (hazard interval rates not considered). The rate of structural valve deterioration was CE-S 1.8% per patient-year (79 prostheses) and CE-SA 0.2% (four prostheses). The reoperation rate was 2.5% per patient-year (110 prostheses) for CE-S and for CE-SA it was 0.9% (six prostheses). The late mortality rate was 3.7% per patient-year and 4.2%, respectively. The 10-year freedom rates for CE-S were thromboembolism, 82.7 +/- 2.8%; prosthetic valve endocarditis, 93.5 +/- 1.6%; structural valve deterioration, 77.1 +/- 2.9%; reoperation, 69.9 +/- 3.1%; valve related mortality, 85.9 +/- 2.4%; valve failure, 62.8 +/- 3.2%; treatment failure, 82.0 +/- 2.7%; mortality, reoperation and residual morbidity, 59.5 +/- 3.2%; and all complications, 53.4 +/- 3.1%. The four-year freedom rates for CE-SA were thromboembolism, 93.0 +/- 1.3%; prosthetic valve endocarditis, 98.7 +/- 0.5%; structural valve deterioration, 98.3 +/- 1.0%; reoperation, 95.6 +/- 1.3%; mortality, 97.9 +/- 0.6%; valve failure, 93.6 +/- 1.4%; treatment failure, 94.6 +/- 1.1%; mortality, reoperation and residual morbidity, 90.9 +/- 1.6%; and all complications, 85.6 +/- 1.9%.(ABSTRACT TRUNCATED AT 250 WORDS)

Bioprosthesis↗
PubMed1986

Carpentier-Edwards supra-annular porcine bioprosthesis. Clinical experience and implantation characteristics.

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

Bioprosthesis↗
PubMed1984

Five-year evaluation of the Carpentier-Edwards porcine bioprosthesis.

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

Adolescent↗