Carpentier-Edwards Porcine Bioprosthesis Research Articles

Long-Term Survival Benefits of Porcine versus Pericardial Bioprostheses in Elderly Patients Undergoing Isolated Aortic Valve Replacement: A 32-Year Study.

The elderly population is growing at an unprecedented rate. Aortic valve disease increases with age. Bioprostheses are the valves of choice for older patients; however, the optimal tissue valve remains undetermined. The purpose of this investigation was to perform a life-of-patient survival comparison of the prototypical porcine and pericardial prostheses in elderly patients. The study population (N = 1480) consisted of patients 65 years of age and older who underwent isolated aortic valve replacement from 1990 through 2005 with a Carpentier-Edwards Porcine (n = 650) or Pericardial (n = 830) bioprosthesis. Propensity score-matched groups were created. Valve selection was not associated with operative mortality. Survival estimates at 10 years were better for Pericardial (41.8%; 95% CI: 37.9 to 45.7) than Porcine (32.6%; 95% CI: 28.8 to 36.3); and 5.2% (95% CI: 3.2 to 7.1) versus 2.0%; (95% CI: 0.8 to 3.2) at 20 years (p < 0.001). E-value analysis found minimal influence of unknown study confounders. Factors associated with long-term mortality were porcine valve (p < 0.001), age (p < 0.001), diabetes mellitus (p < 0.001), preop renal insufficiency (p < 0.001), peripheral artery disease (p = 0.011), congestive heart failure (p = 0.003), New York Heart Association Class III or IV (p = 0.004), surgical history-reoperation (p = 0.012), transient ischemic attack (p = 0.009), prolonged ventilation (p = 0.010), postop renal insufficiency (p < 0.001), and atrial fibrillation (p = 0.009). The indexed Effective Orifice Area (EOAi) was assessed and did not influence observed long-term survival differences. This unusual lifetime study provided substantial evidence for the superiority of the pericardial over the porcine bioprosthesis in the aortic position in elderly patients. It demonstrated enhanced long-term survival benefits for elderly patients without any increase in perioperative mortality. It is intended to inform future investigation into aortic valve design.

Durability of pericardial versus porcine aortic valves

ObjectivesThis study compares the long-term performance of the Carpentier-Edwards (CE) porcine bioprosthesis and the CE pericardial bioprosthesis for aortic valve replacement (AVR). BackgroundWith new bioprostheses on the horizon, there is renewed interest in how the long-term durability of current pericardial bioprostheses compares with the traditional porcine bioprosthesis. MethodsWe reviewed 518 AVR with CE porcine valves from 1974 to 1996 and 1,021 AVR with CE pericardial valves from 1991 to 2002. The age distribution and clinical profiles were similar for both groups. The total (mean) follow-up was 3,322 (6.4) years for porcine and 2,556 (2.5) years for pericardial. ResultsLong-term mortality was similar (p = 0.29) for porcine and pericardial, with 10-year survival rates of 34 ± 2% and 38 ± 6%, respectively. Ten-year freedom from major adverse cardiac events was also similar for both (respectively): thromboembolism (80 ± 2% and 87 ± 2%; p = 0.24); endocarditis (98 ± 1% and 99 ± 1%; p = 0.30). However, 10-year freedom from explant was lower for porcine (90 ± 2%) than for pericardial (97 ± 1%, p = 0.04). Reasons for explant for porcine were structural valve deterioration (SVD) (n = 25), endocarditis (n = 4), and periprosthetic leak (n = 2). The reasons for explant for pericardial were SVD (n = 4), endocarditis (n = 4) and periprosthetic leak (n = 1). ConclusionsThe current CE pericardial valve offers better midterm durability than the traditional CE porcine valve. Its freedom from SVD and reoperation makes it our current bioprosthesis of choice for AVR in appropriately selected patients.

Host tissue overgrowth in a mitral valve conserving procedure

This 86-year-old man presented at our institution with gradual onset of fatigue, increasing shortness of breath, ankle edema and dry cough. Eleven years earlier, he had undergone mitral valve replacement with a 29-mm Carpentier-Edwards (Edwards Heart Valve Division, Irvine, CA) porcine bioprosthesis (CEP) in Florida. The valve had been placed in the supra-annular position and the mitral valve leaflets were conserved. Relevant past history includes chronic anemia attributed to microscopic hematuria (Hgb = 100). He was diagnosed with congestive heart failure (CHF) attributed to mitral bioprosthetic valve dysfunction and severe mitral regurgitation (MR). Cardiac catheterization showed pulmonary venous hypertension and mild interstitial pulmonary edema (pulmonary artery pressure = 51 mm Hg, left ventricular end diastolic pressure = 25 mm Hg, cardiac output = 5.1 l/min). Left ventricular function was normal and severe MR was noted. The LAD was 25% stenosed with diffuse thickening and the RCA ostium was 70% stenosed. The trans-thoracic echocardiogram (TTE) showed moderate left atrial dilatation and thickening of the aortic cusp with satisfactory cusp separation. The mitral valve was stable but angulated slightly towards the septum. Other valvular structures were normal. TTE showed that MR was secondary to prolapse and/or dehiscence of at least one prosthetic cusp. Wall thickness and systolic function were normal. The patient underwent mitral bioprosthetic valve replacement with concomitant saphenous vein bypass grafts to the LAD and RCA. The 11-year-old CEP was replaced with a 29-mm Hancock porcine bioprosthesis. The patient made an uneventful recovery and was released from hospital 15 days postoperative.

Midterm results of aortic valve replacement with Carpentier-Edwards porcine bioprosthesis

Since 1987 we have been using Carpentier-Edwards porcine bioprostheses for aortic valve replacements in patients of advanced age and those with a contraindication for anticoagulation therapy. The purpose of this study was to provide insight into the midterm results of our series of patients with Carpentier-Edwards porcine bioprostheses in the aortic position. From September 1987 through June 1999, 31 patients underwent aortic valve replacement with Capentier-Edwards porcine bioprostheses. The age of the patients ranged from 21 to 89 (average, 71 ± 11 years old), and 21 patients (67.7%) were 70 years old or older. There were no operative deaths. Three hospital deaths (9.7%) and one nonhospital death (3.2%) took place. The actuarial survival rate of 31 patients was 90.3% at 5 years and 81.3% at 7 years. Valve-related complications were seen in six patients (19.4%). The postoperative Doppler peak gradient of aortic prostheses was less than 30 mm Hg in all groups, irrespective of valve size. In conclusion, the Carpentier-Edwards porcine bioprosthesis affords good durability with a low rate of valve-related complications and reoperation. Furthermore, the postoperative function of the prosthesis was reasonable in the Doppler echo studies.

An Unusual Complication Associated with the Carpentier-Edwards Porcine Bioprosthesis

Primary tissue failure of bioprosthetic heart valves refers primarily to calcification of the leaflets of the bioprosthesis. A 75 year old patient underwent reoperation 15 years after mitral valve replacement with a Carpentier-Edwards porcine bioprosthesis. The extracted bioprosthetic valve was found to have one prolapsed leaflet and a small amount of calcification on all three leaflets without tear or perforation. The two commissures suspending the prolapsed leaflet were detached, causing mitral valve regurgitation.

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

Background. The Carpentier–Edwards supraannular porcine bioprosthesis experience for more than 18 years has been evaluated by actuarial and actual analysis to determine the clinical performance in aortic valve replacement.Methods. From 1981 to 1998, 1,823 patients (mean age 68.5 years, range 20 to 90 years) underwent 1,846 procedures. Previous coronary artery bypass was performed in 3.1% (56) and previous valve repair/replacement in 6.0% (110). Concomitant coronary artery bypass grafting was performed in 41.5% (756).Results. The overall valve-related complication rate was 4.5%/patient-year (567 patients) with a fatality rate of 0.9%/patient-year (110 patients). The patient survival, at 15 years, was 33.0% ± 3.7% for the 61 to 70 years age group and 13.5% ± 2.4% for the older than 70 years group. At 15 years, the overall actual, cumulative freedom from reoperation was 83.2% ± 1.4%, valve-related mortality was 88.0% ± 1.2%, and valve-related residual morbidity was 92.0% ± 0.8%. The actual freedom from structural valve deterioration at 15 years was 84.2% ± 2.8% for the 61 to 70 years group and 97.1% ± 0.9% for the older than 70 years group.Conclusions. The Carpentier–Edwards porcine bioprosthesis provides excellent freedom from structural valve deterioration, and overall freedom from valve-related morbidity, mortality, and reoperation for aortic valve replacement for up to 15 years. The prosthesis is recommended for patients older than 70 years and for patients 61 to 70 years, especially when extended survival is not anticipated.

Carpentier-Edwards Bioprosthesis: Experiences of 17 Years with Analysis of Risk Factors of Early Mortality

Isolated aortic (AVR, N = 71), mitral (MVR, N = 103), tricuspid (TVR, N = 3), pulmonary (PVR, N = 8), combined AVR + MVR (N = 4), or combined MVR + TVR (N = 2) valve replacement with a Carpentier-Edwards porcine bioprosthesis was performed in 191 patients between 1979 and 1986. Mean age was 56.9 ± 17 (range 5–80) years in the total cohort. The operative mortality rates were 5.6% and 8.7%, respectively, for AVR and MVR. Mean observation time was 8 ± 4.2 (0–16.7) years (total = 1,467 patient-years). Follow-up was 100% complete with respect to mortality. There were 78 late deaths (44%). Actuarial survival rates at 5 and 10 years were 73.2 ± 5.2 and 52.1 ± 6.6 for AVR and 76.7 ± 4.2 and 61.6 ± 4.8 for MVR. Coronary artery disease, concomitant coronary artery bypass grafting and emergency operation were significant risk factors of early mortality (p < 0.05). Postoperatively, sepsis and multiorgan failure were associated with early mortality (p < 0.05). The 10-year actuarial freedom from structural deterioration for AVR was 89 ± 4.6 and 76.4 ± 4.3 for MVR. It is concluded that structural valve failure is the most important factor that adversely affects the performance of Carpentier-Edwards bioprosthesis.

Durability of the Carpentier-Edwards porcine bioprosthesis: Role of age and valve position

The durability (structural deterioration-free interval) after valve implantation with the first-generation Carpentier-Edwards porcine bioprosthesis has been investigated. From 1978 through 1984, 420 patients (175 male, 245 female) underwent valve replacement with the Carpentier-Edwards standard bioprosthesis. Mean age was 50.6 years (range, 13 to 77 years). Isolated mitral valve replacement (MVR) was performed in 198 patients (47.1%), aortic valve replacement (AVR) in 136 (32.4%), and double valve replacement (DVR) in 86 (20.5%). Hospital mortality was 32 patients (7.6%), 7.5% for MVR, 5.1% for AVR, and 11.6% for DVR. Mean follow-up was 10.8 years (range, 9 to 15 years) and is 96.2% completed. Reoperation for structural deterioration was required in 143 patients. Actuarial curve free from structural deterioration at 15 years is 33.0% +/- 6.5% for MVR, 62.0% +/- 5.1% for AVR, and 44.2% +/- 8.2% for DVR (p < 0.03). Durability of the CE bioprosthesis for MVR was 101.6 +/- 34.5 months, 92.9 +/- 26.4 for AVR, and 84.3 +/- 25.3 for DVR (p = not significant). The regression logistic analysis between age at the time of surgery and durability of the bioprosthesis showed no correlation for the MVR group, but with the following predictive formula for AVR and DVR groups of patients older than 30 years" durability = 46.05 + 0.818 x age, for AVR (r2 = 0.43); durability = 15.81 + 1.122 x age, for DVR (r2 = 0.52). In conclusion, we have found a significant difference in the behavior of the CE porcine bioprosthesis between the mitral and aortic position.(ABSTRACT TRUNCATED AT 250 WORDS)

910-17 The Appropriate Choice of a Cardiac Valve Prosthesis in Elderly Patients

The long-term durability of the Carpentier-Edwards bioprosthesis in elderly patients exceeds 90% at the end of the first decade. This extensive and long-term experience provides further impetus for the continued use of this valve substitute with these patients. From October 1977 to June 1994, 700 patients 70 years of age and over underwent valve replacement using a Carpentier-Edwards porcine bioprosthesis. Ages ranged from 70 to 93 years with a mean of 75.9 ± 4.2. There were 398 men (56.9%) and 302 women (43.1%). Preoperatively, 98.7% of the patients were in New York Heart Association functional class III or IV In 74 patients (1 0.6%)the surgery represented a reoperation. There were 188 126.9%) isolated aortic valve replacements, 109 (15.6%) iSOlated mitral valve replacements, and 403 (57.6%) combined procedures which included the replacement of at least one valve. There were 42 (6.0%) double valve replacements in the series. Surgery was performed as an emergency in 42 patients (6.0%). Hospital mortality was 10.1% (7l patients) with 629 hospital survivors. There were 661 valves at risk. Follow-up extended from one month to 15.4 years with a mean of 48.1 months. The cumulative follow-up was 2,518.7 patient-years. A total of six valves failed from structural deterioration, one in the aortic and five in the mitral site ( p &lt; 0.004). Actuarial freedom from valve structural deterioration at six years was 99.0 ± 0.5% standard error of the mean (SEM; 180 valves at risk) and 93.0 ± 3.5% SEM (eight valves at risk) at 12 years. Gender did not influence structural deterioration; however, valve site did ( p &lt; 0.004). The results of this large and long-term experience reinforces the continued use of this device in elderly patients. The paucity of valve failures and a demonstrated enhanced quality of life experienced by hospital survivors provides further evidence for the use of the Carpentier-Edwards bioprosthesis in elderly patients with acquired valvular heart disease.

In Vitro Pulsatile Flow Evaluation of a Stentless Porcine Aortic Bioprosthesis

Suboptimal hemodynamic performance, tissue calcification, and limitation in long-term durability have been encountered clinically after aortic valve replacement with currently available bioprostheses. It is believed that some of these problems may be caused, directly or indirectly, by the stents of the bioprostheses. To address these deficiencies, the authors undertook the development of the Edwards Prima Stentless Bioprosthesis. This study was designed to evaluate the hemodynamic performance of the Edwards Prima Stentless Bioprosthesis in a pulse duplicator system. The stented Carpentier-Edwards Porcine Bioprosthesis (Baxter Healthcare Corp., Irvine, CA), which has been used in United States clinics for more than 10 years, was used as a control device. The flow fields in the vicinity of the test bioprostheses were inspected with color Doppler flow mapping. The transvalvular pressure gradients were measured invasively with a catheter and calculated with the Doppler determined velocity using a simplified Bernoulli equation. Additionally, the leakage volumes were determined with an electromagnetic flowmeter. In the Doppler flow mapping study, during systole, a central flow was observed distal to the stentless and stented bioprostheses. The central flow distal to the stentless bioprosthesis was broader than that observed distal to its stented counterpart. During diastole, no regurgitation was detected by color Doppler flow mapping in either the stentless or stented groups. The Doppler determined transvalvular pressure gradients correlated well with those measured by catheter (r = 0.990). Moreover, it was learned that the transvalvular pressure gradients of the stentless bioprosthesis were less than those of its stented counterpart, especially for the smaller sizes.(ABSTRACT TRUNCATED AT 250 WORDS)

Clinical and hemodynamic performance of the 19-mm Carpentier-Edwards porcine bioprosthesis

Because of concerns about the hemodynamic performance of 19-mm porcine valves, we retrospectively reviewed the clinical results and echocardiographic studies of 52 consecutive patients who received a 19-mm Carpentier-Edwards porcine bioprosthesis (model 2625) for aortic valve replacement from 1986 through 1991. Nearly 87% of the patients were women, the mean age was 69 years, and the mean body surface area was 1.63 ± 0.27 m 2. Seventy-three percent of the patients had pure aortic stenosis, 96% were in New York Heart Association classes III and IV, and 56% underwent urgent or emergent operation. Overall hospital mortality was 7.7% with a late mortality of 8.3% at a mean follow-up of 25 ± 18 months. No patient experienced a valve related complication, and 95% of surviving patients were in New York Heart Association classes I and II. Two-dimensional and Doppler echocardiography performed during the first postoperative week revealed a maximal instantaneous gradient of 44.7 ± 13.0 mm Hg. In 43 patients for whom additional data were available, the mean gradient was 26.4 ± 8.2 mm Hg with an effective orifice area of 0.85 ± 0.18 cm 2. This study defines the normal range of postoperative gradients across the 19-mm Carpentier-Edwards porcine valve and demonstrates that patients receiving this valve can achieve significant clinical improvement despite the presence of high transvalvular gradients measured by echocardiography.

Early Thrombotic Stenosis of Aortic Bioprosthetic Valves: Report of Two Cases

Thrombotic stenosis of a Carpentier-Edwards porcine bioprosthesis occurred in two patients within 3 months after aortic valve replacement. Both patients underwent successful replacement of the aortic prosthesis. Although previously reported, this complication of aortic porcine bioprostheses is uncommon.

The Carpentier-Edwards standard porcine bioprosthesis: A first-generation tissue valve with excellent long-term clinical performance

The Carpentier-Edwards standard porcine bioprosthesis was implanted in 1190 patients (1201 operations, 1303 valves) between January 1975 and June 1986; most implants were before 1982. The mean age of the patients was 57.2 years (range 8 to 85 years). The early mortality was 7.6% (aortic valve replacement 5.1%, mitral valve replacement 8.8%, and multiple valve replacement 15.3%). Late mortality was 3.9% per patient-year (aortic valve replacement 3.6%, mitral valve replacement 4.2%, and multiple valve replacement 3.8%). The total cumulative follow-up period was 6737 years. Thromboembolism was 1.5% per patient-year (fatal 0.4% per patient-year) (minor 0.6%, major 0.9%); antithromboembolic therapy-related hemorrhage was 0.5% (fatal 0.1%); prosthetic valve endocarditis was 0.6% (fatal 0.2%); nonstructural dysfunction was 0.5% (fatal 0.2%); and structural valve deterioration and/or primary tissue failure was 1.5% per patient-year (fatal, 0.2% per patient-year). Thromboembolism and structural valve deterioration were the significant complications, structural valve deterioration occurring primarily between the sixth and 10th year of evaluation. The overall patient survival was 65.0% for aortic valve replacement and 54.8% for mitral valve replacement (p less than 0.05) at 10 years. The patients were classified as 92.9% New York Heart Association functional classes III and IV preoperatively and 92.3% classes I and II postoperatively. Freedom at 10 years from thromboembolism was 84.3% for aortic valve replacement and 76.5% for mitral valve replacement (p = 0.05); structural valve deterioration was 78.6% for aortic valve replacement and 71.6% for mitral valve replacement (p less than 0.05); reoperation was 74.4% for aortic valve replacement and 67.1% for mitral valve replacement (p less than 0.05). Freedom from all valve-related complications at 10 years was 58.9% for aortic valve replacement and 46.8% for mitral valve replacement (p less than 0.05); valve-related mortality was 89.5% for aortic valve replacement and 82.6% for mitral valve replacement (p = not significant); mortality and reoperation was 58.9% for aortic valve replacement and 46.8% for mitral valve replacement (p less than 0.05); mortality and residual morbidity (treatment failure) was 87.2% for aortic valve replacement and 75.1% for mitral valve replacement (p = not significant); mortality, residual morbidity, and reoperation were 66.3% for aortic valve replacement and 54.9% for mitral valve replacement (p less than 0.05). The standard Carpentier-Edwards porcine bioprosthesis has provided satisfactory clinical performance and has afforded patients excellent quality of life.

A 10-year comparison of mitral valve replacement with Carpentier-Edwards and Hancock porcine bioprostheses

Two hundred fifty-three patients who underwent isolated mitral valve replacement with a porcine bioprosthesis had long-term evaluation. One hundred forty-seven patients received a Carpentier-Edwards porcine bioprosthesis and 106, a Hancock valve. There were no significant differences in preoperative clinical characteristics between the two groups. Cumulative follow-up was 1,375 patient-years. At 10 years, 93% ± 2.5% of the patients in the Carpentier-Edwards group and 85% ± 7.8% of those in the Hancock group were free from valve-related death (not significant), and 95% ± 2% and 91% ± 3.8%, respectively, were free ton thromboembolism (not significant). At 10 years, 65% ± 7.2% of the patients in the Carpentier-Edwards group and 66% ± 7.2% of those in the Hancock group were free from structural valve deterioration (not significant), and 64% ± 6% and 59% ± 7.3%, respectively, were free from reoperation (not significant). We conclude that the first generation of Carpentier-Edwards and Hancock prostheses produce comparable long-term results in the mitral position.

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.

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.

Comparative Clinical Experience with Porcine Bioprosthetic and St. Jude Valve Replacement

From 1976 to 1984, 656 patients underwent aortic, mitral, or double valve replacement with a Hancock or Carpentier-Edwards porcine bioprosthesis (POR; n = 293) or with a St. Jude bileaflet valve (SJ; n = 363). Recipients of the St. Jude valve were of more advanced NYHA class preoperatively, required smaller prosthetic sizes, and more often had associated coronary artery disease necessitating bypass grafting (p less than .05). Despite these differences, POR and SJ recipients demonstrated similar 30-day mortality (7.5 vs 10.2 percent), five-year freedom from embolism (92 +/- 2 percent vs 92 +/- 2 percent), freedom from all valve-related complications (79 +/- 3 percent vs 79 +/- 4 percent), and survival (72 +/- 3 percent vs 71 +/- 3 percent) (p = NS). Structural failures occurred exclusively in POR recipients (3.0-4.5 percent/pt-yr after four years), and endocarditis was more common (1.0 vs 0.5 percent/pt-yr); as a result, the reoperation rate was three times higher in POR than SJ recipients (1.4 vs 0.46 percent/pt-yr, p less than .05). Warfarin-related bleeding (2.5 percent/pt-yr) was the most common complication in SJ recipients, but occurred equally frequently in POR recipients requiring anticoagulation; seven (44 percent) of 16 valve-related late deaths were warfarin-related. In properly anticoagulated patients, the thromboembolic rate was low (2.0 percent and 1.1 percent/pt-yr, POR and SJ); this rate increased significantly in SJ recipients receiving antiplatelet drugs alone (4.2 percent/pt-yr; n = 16) or no anticoagulant or antiplatelet therapy (26.4 percent/pt-yr; n = 18) (p less than .05), but increased only slightly in POR recipients (to 1.5 percent/pt-yr, n = 108, and 2.0 percent/pt-yr, n = 63, respectively). Postoperatively, NYHA class 1 was more often achieved in SJ than POR recipients (60 vs 39 percent, p less than .05), perhaps because of the better hemodynamic performance of the SJ valve. Thus, despite differences in patient selection and the nature of complications observed with each prosthetic type, porcine and St. Jude valves provide similar early and late survival, frequency of embolism, total complication rate, and freedom from valve-related morbidity and mortality after five years of follow-up. Limited durability, susceptibility to infection, and inferior hemodynamics remain drawbacks to use of the porcine bioprosthesis. The necessity for warfarin anticoagulation and the frequency of resultant bleeding complications are the major shortcomings of the St. Jude valve.(ABSTRACT TRUNCATED AT 400 WORDS)

Early thrombosis of a porcine bioprosthesis in the aortic valve position

Thrombosis of a porcine bioprosthesis in the aortic valve position is uncommon and usually occurs more than 1 year after implantation. 1 Only 3 patients with thrombosis of a porcine aortic valve bioprosthesis less than 1 year after insertion have been described. 2–4 We report life-threatening thrombosis of a Carpentier-Edwards porcine bioprosthesis in the aortic valve position 6 months postoperatively.

In vivo hemodynamic comparison of porcine and pericardial valves

The bovine pericardial valve and the SupraAnnular valve have been developed to improve the hemodynamic function of tissue valves. Hemodynamic performances of the standard Carpentier-Edwards porcine valve, the Carpentier-Edwards SupraAnnular valve, and the Carpentier-Edwards bovine pericardial valve were compared in the aortic position. One hundred patients undergoing aortic valve replacement were studied intraoperatively. Mean gradient across the valve decreased for standard and pericardial valves as valve size increased. At the same flow rate, the 23 mm pericardial valve had larger valve orifice areas, higher performance indices, and lower gradients than the 23 mm SupraAnnular valve. The SupraAnnular valve is hemodynamically superior to the standard Carpentier-Edwards porcine bioprosthesis. The Carpentier-Edwards pericardial valve, however, is less obstructive in the aortic position than either of the porcine valves.

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.