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Background: Freedom from structural valve deterioration (SVD) at 15 years with the Carpentier-Edwards (CE) Perimount pericardial valve in the aortic position was 60% in patients aged <60 years compared to 90% and 99% in patients aged 60-70 years and >70 years, respectively. The study aim was to focus on the causes of SVD requiring valve explant according to three different age groups: <60 years, 60-70 years, and >70 years. The short- and longterm clinical results of the patient cohort, followed for 25 years, are presented., Methods: A retrospective review was made of 89 patients among 2,405 who had undergone elective aortic valve replacement (AVR) with CE pericardial valves between November 1981 and March 2011, and in whom the prosthesis explant was secondary to degeneration of the valve., Results: Patients aged >70 years experienced more late complications such as endocarditis (p = 0.02) and mortality (p = 0.02). Following surgery for prosthesis explant and replacement, 39 of the 89 patients (44%) died. The average time to postoperative mortality in that population was 2.8 ± 3.6 years. On combining all causes of SVD, earlier dysfunction was noted in patients aged >60 years, and late dysfunction in patients aged <60 years (p = 0.003). However, there was no significant difference between groups in the process of degeneration (either calcification, pannus, tear, thrombus, endocarditis) (p = NS). No predictors were found of early and late dysfunction., Conclusions: Patients aged >60 years in whom a CE Perimount valve was implanted in the aortic position were more prone to early degeneration of their valve and related mortality. However, no predictors were found of early degeneration of the valve in that patient population.

Objectives: Sutureless aortic valves are deemed suitable for patients considered at high risk for surgery. The objective of this study is to evaluate the perioperative results of implanting a sutureless valve in elderly persons, compared with a stented biological valve in the aortic position., Methods: Between 2011 and 2015, 76 patients underwent aortic valve replacement with the Perceval prosthesis (Sorin Group, Saluggia, Italy). The group was compared with 319 consecutive patients who received aortic valve replacement with the stented valve in that same period., Results: The mean age of patients was 83 ± 2 years in the Perceval group and 83 ± 3 years in the stented valve group (P = .3). Preoperative demographics were similar in both groups. Median cardiopulmonary bypass and crossclamp times were lower in the Perceval group than in the stented valve group (P < .001). Mortality was 5% in the Perceval group and 6% in the stented valve group (P = .8). There were more pacemaker implantations in the Perceval group than in the stented valve group (17% vs 8%; P = .02). A subgroup analysis of patients who underwent aortic valve replacement and concomitant procedures showed the same results as the entire cohort., Conclusions: Aortic valve replacement with a sutureless prosthesis resulted in shorter aortic crossclamp and bypass times compared with a stented biological prosthesis. The reduced cardiopulmonary bypass and aortic crossclamp times obtained using the Perceval prosthesis did not translate into perioperative gains in our population of elderly patients., (Copyright © 2016 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.)

Background: With improved durability of contemporary bioprostheses, surgeons are now recommending biologic valves in younger patients. However, long-term outcomes of patients younger than 60 years old undergoing biologic aortic valve implantation are not well known., Methods: From November 1991 to March 2011, 144 patients less than 60 years old underwent aortic valve replacement (AVR) with Carpentier-Edwards pericardial valves (Edwards Lifesciences, Irvine, CA). Mean follow-up was 10±4 years. Outcomes were reported according to published guidelines., Results: Seventy-five percent of patients were male, with a mean age of 51±9 years. Actuarial survival rates including early deaths were 89%±3%, 79%±4%, and 57%±6% after 5, 10, and 15 years of follow-up, respectively. Survival of patients was comparatively lower than a gender- and age-matched general population at all time points. The freedom from major adverse cardiac events (myocardial infarction, heart failure, hemorrhage, thromboembolic event, and endocarditis) was 89%±3%, 87%±3%, and 75%±6% at 5, 10, and 15 years after surgery. The freedom rate from prosthetic valve dysfunction was 97%±2%, 84%±4%, and 57%±6% at 5, 10, and 15 years after surgery. Patients with a diagnosis of structural valve deterioration (29 of 37, 78%) underwent reoperation 11±5 years after the initial valve replacement with no perioperative mortality., Conclusions: In patients younger than 60 years undergoing AVR, the Carpentier-Edwards Perimount bioprosthesis provided satisfactory clinical outcomes. However, late survival was inferior to an age- and gender-matched population. Structural valve deterioration and the need for reintervention were common late after implantation, but reoperation for prosthetic valve dysfunction was associated with a very low risk of mortality., (Copyright © 2014 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Background: The purpose of this study was to carry out a current assessment of the Mitroflow pericardial bioprosthesis (model 11) according to the durability of the prosthesis after 15 years in patients aged 60 years or older., Methods: This bioprosthesis was implanted in 161 patients (mean age 69.5 +/- 6.3 years; range 60 - 94 years) undergoing aortic valve replacement (AVR) between 1982 and 1992. There were 84 patients aged 60 - 69 years (mean 64.5 +/- 3.1years) and 77 patients aged 70 years or older (mean 74.8 +/- 4.3 years). Of the total population, concomitant procedures were performed in 63 patients (39.1 %); of these, coronary artery bypass grafting was performed in 39 (24.2 %)., Results: Early mortality was 4.8 % (4 patients) in the 60 - 69 year age group and 10.4 % (8) in patients aged 70 years or older ( P = 0.290). Late mortality was 4.5 %/patient-year (35) for those aged 60 - 69 years and 8.1 %/patient-year (49) for those aged 70 years or older ( P = 0.007). Patient survival at 15 years of patients aged 60 - 69 years was 47.6 +/- 6.3 % and of patients aged 70 years or older was 20.9 +/- 5.4 % ( P = 0.003) ( ). Freedom from valve-related mortality for patients in the 60 - 69 year age group was 92.1 +/- 3.5 % at 15 years (0.6 %/patient-year [5]), and in the patient group aged 70 years or older it was 84.4 +/- 5.3 % (1.3 %/patient-year [8]; P = 0.194). Freedom from reoperation for patients in the 60 - 69 year age group was 73.9 +/- 5.0 % (2.6 %/patient-year [20]), and for patients aged 70 years or older it was 91.4 +/- 3.4 % (1.0 %/patient-year [6]; P = 0.029). The structural valve deterioration (SVD) rate for patients in the 60 - 69 year age group was 2.4 %/patient-year (19), and for patients aged 70 years or older it was 1.0 %/patient-year (6) ( P = 0.041). Actuarial freedom from structural valve deterioration at 15 years for patients aged 60 - 69 years was 62.0 +/- 7.3 %, and 80.8 +/- 7.9 % for patients aged 70 years and older ( P = 0.049) (actual freedom 73.9 +/- 5.2 % and 91.4 +/- 3.4 %, respectively)., Conclusions: The Mitroflow pericardial bioprosthesis can still be recommended for aortic valve replacement in patients 70 years and older.

Background: Tricuspid valve replacement is seldom used in clinical practice, but the choice between mechanical and biologic prostheses remains controversial., Methods: Between 1977 and 2002, 97 patients underwent tricuspid valve replacement and were followed at the Montreal Heart Institute Valve Clinic. Patients underwent replacement with bioprostheses (n = 82) and mechanical valves (n = 15)., Results: Patients with bioprosthetic tricuspid replacements averaged 53 +/- 13 years of age compared with 48 +/- 11 years in those with tricuspid mechanical valve replacements (p = 0.2). Isolated tricuspid valve replacement was performed in 11 patients (73%) in the mechanical valve group compared with 31 patients (38%. p = 0.01) in the bioprosthetic replacement group. In patients undergoing bioprosthetic tricuspid replacement, 51 (62%) underwent multiple associated valve replacements. The 5-year survival after tricuspid replacement averaged 60% +/- 13% in the mechanical valve group and 56% +/- 6% in the biologic replacement group (p = 0.8). The 5-year freedom rate from tricuspid valve reoperation averaged 91% +/- 9% in patients with mechanical valves and 97% +/- 3% in those with biologic valves (p = 0.2). CONCLUSIONS; Patient survival after tricuspid valve replacement is suboptimal but related to the clinical condition at operation. The use of biologic prostheses for tricuspid valve replacement remains a good option in young patients because of limited life expectancy unrelated to the type of tricuspid prostheses at long-term follow-up.

Background: Valve replacement in small aortic root remains a surgical challenge. The objective of this study was to compare results of the 19-mm bioprosthesis with those of larger prostheses in the elderly., Methods: The 443 patients, 70 years of age and older, who underwent aortic valve replacement with Carpentier-Edwards pericardial bioprostheses were reviewed., Results: There were 93 patients with a mean age of 76+/-4 years with implantation of 19-mm prostheses and 350 patients with a mean age of 75+/-4 years with larger bioprostheses. Associated aortoplasty was performed in 10 patients (11%) with 19-mm bioprostheses and in 8 patients (2%) with larger bioprostheses (p = 0.001). There were 11 deaths (12%) within 30 days of surgery in patients with 19-mm prostheses and 22 deaths (6%) among those with larger prostheses (p = 0.1). The 7-year survival rate averaged 61%+/-7% in patients with 19-mm prostheses and 67%+/-4% in those with larger prostheses (p = 0.8). The 7-year freedom rates from all valve-related events averaged 96%+/-2% and 93%+/-2%, respectively (p = 0.6)., Conclusions: Aortic valve replacement with the 19-mm Carpentier-Edwards pericardial bioprosthesis offers excellent midterm results in the elderly.

Background: Mechanical prostheses are used in young patients and bioprostheses in the elderly because of the higher rate of structural failure of bioprostheses. The objective of the present study was to compare results after aortic valve replacement with mechanical (Carbo-Medics) and biologic (Carpentier-Edwards pericardial) in middle-aged patients., Methods: Five hundred twenty-one patients, aged between 55 and 65 years, who underwent aortic valve replacement with mechanical (n = 363) or biologic (n = 158) prostheses were reviewed., Results: The 10-year actuarial survival rate averaged 66%+/-6% in patients implanted with mechanical valves compared with 75%+/-4% in patients implanted with biologic valves (p = 0.2). The 10-year freedom rate from thromboembolism, hemorrhage, and endocarditis averaged 92%+/-7%, 97%+/-2%, and 99%+/-1%, respectively, in patients with mechanical valves compared with 91%+/-3% (p = 0.03), 99%+/-1% (p = 0.4), and 95%+/-2% (p = 0.01), respectively, in those with biologic valves. The 10-year freedom rate from all valve-related complications averaged 90%+/-7% and 83%+/-4%, respectively (p = 0.01)., Conclusions: The freedom rate from all valve-related complications was higher among patients with mechanical valves compared with biologic valves 10 years after aortic valve replacement in middle-aged patients.

Background: This multicenter study concerning the mitral PERIMOUNT valve previously reported clinical results at 12 years; this report updates the performance to 15 years postoperatively., Methods: The 435 patients (mean age 60.7+/-11.6 years; 41.1% male) underwent implantation with the PERIMOUNT valve between 1984 and 1989 at seven institutions. Follow-up was complete for 96.1% of the cohort. The mean follow-up was 8.1+/-4.4 years (range 0 to 15.4 years) for a total of 3492 patient-years., Results: There were 34 (7.8%) operative deaths, one (0.2%) valve related. The late mortality rate was 5.3%/patient-year (2.2%/patient-year valve related). At 14 years, the overall actuarial survival rate was 37.1%+/-3.3% (63.1%+/-4.4% valve related). Actuarial freedom from complications at 14 years was as follows: thromboembolism, 83.8%+/-3.2% (1.1%/patient-year); hemorrhage, 86.6%+/-3.2% (1.1%/patient-year); and explant due to structural valve deterioration (SVD), 68.8%+/-4.7%. Actual freedom from explant due to SVD was 83.4%+/-2.3%. Rates of structural failure decreased with increasing age at implant., Conclusions: The Carpentier-Edwards PERIMOUNT Pericardial Bioprosthesis is a reliable choice for a tissue valve in the mitral position, especially in patients more than 60 years of age.

Background: Bioprostheses preserved with glutaraldehyde, both porcine and pericardial, have been available as second-generation prostheses for valve replacement surgery. The performance with regard to structural valve deterioration with the Carpentier-Edwards supra-annular (CE-SAV) porcine bioprosthesis and the Carpentier-Edwards Perimount (CE-P) pericardial bioprosthesis (Baxter Healthcare Corp, Edwards Division, Santa Ana, Calif) was evaluated to determine whether there was a difference in mitral valve replacement., Methods: The CE-SAV bioprosthesis was implanted in 1266 overall mitral valve replacements (isolated mitral, 1066; mitral in multiple, 200) and the CE-P bioprosthesis in 429 overall mitral valve replacements (isolated mitral, 328; mitral in multiple, 101). The mean age of the CE-SAV population was 64.2 +/- 12.2 years and that of the CE-P population, 60.7 +/- 11.7 years (P =.0001). For the study, structural valve deterioration was diagnosed at reoperation for explantation., Results: The freedom from structural valve deterioration was evaluated to 10 years, and the freedom rates reported are at 10 years. For the overall mitral valve replacement groups, the actuarial freedom from deterioration was significant (P =.0001): CE-P > CE-SAV for 40 years or younger, 80% versus 60%; 41 to 50 years, 91% versus 61%; 51 to 60 years, 84% versus 69%; 61 to 70 years, 95% versus 75%. The older than 70-year group was 100% versus 92% (no significant difference). The actual freedom from structural valve deterioration also demonstrated the same pattern at 10 years: 40 years or younger, CE-P 82% versus CE-SAV 68%; 41 to 50 years, 92% versus 70%; 51 to 60 years, 90% versus 80%; 61 to 70 years, 97% versus 88%; and older than 70 years, 100% versus 97%. The independent risk factors of structural valve deterioration for the overall mitral valve replacement group were age and age groups and prosthesis type (CE-SAV > CE-P). The prosthesis type either in isolated replacement or in multiple replacement was not predictive of structural valve deterioration. The pathology of structural valve deterioration was different: 70% of CE-P failures were due to calcification and 57% of CE-SAV failures were due to combined calcification and leaflet tear., Conclusion: The actuarial and actual freedom from structural valve deterioration, diagnosed at reoperation, is greater at 10 years for CE-P than for CE-SAV bioprostheses. The mode of failure is different, and the cause remains obscure. Long-term evaluation is recommended, because the different modes of failure may alter the clinical performance by 15 and 20 years.

Background: The aim of the study was to evaluate the late results of the Carpentier-Edwards pericardial bioprosthesis, which we have been implanting since 1981., Methods: The 812 patients who underwent heart valve replacement with a Carpentier-Edwards pericardial bioprosthesis between 1981 and 1996 were reviewed. Their clinical, operative, and follow-up data were prospectively recorded in a computerized database. All but 29 patients were available for follow-up (96% completeness), which averaged 58 months and totaled 3,000 patient-years., Results: There were 598 aortic valve replacements (74%), 149 mitral valve replacements (18%), and 65 double valve replacements (8%). The mean age at the time of surgery was 65 years (range, 18 to 88 years), with 24% of the patients under the age of 60 years. Preoperatively, 558 patients (69%) were in New York Heart Association functional class III or IV. Associated surgical procedures included coronary artery bypass grafting in 219 patients (27%) and tricuspid or mitral valve repair in 40 (5%). Previous cardiac operations had been performed in 149 patients, including 134 valve-related procedures. There were 49 early deaths overall (6%): 29 after aortic valve replacement (4.8%), 11 after mitral valve replacement (7.4%), and 9 with double valve replacement (13.8%). There were 120 late deaths for a 10-year actuarial survival rates of 69%+/-3%, 58%+/-7%, and 38%+/-10% for aortic, mitral, and double valve replacement, respectively. The 14-year survival rate for aortic valve replacement patients is 68%+/-3%. The 10-year and 14-year actuarial freedom rates from events after aortic valve replacement are 92% +/-2% and 88%+/-4% for thromboembolism, 96%+/-1% and 92%+/-4 for endocarditis, 91%+/-2 and 72%+/-6% for reoperation, and 93%+/-2% and 80%+/-5% for structural dysfunction of the valve. The 10-year actuarial freedom rates from events after mitral and double valve replacement are 93%+/-3% and 89%+/-4% for thromboembolism, 95%+/-3% and 88%+/-5% for endocarditis, 76%+/-7% and 70%+/-14% for reoperation, and 81%+/-7% and 72%+/-15% for structural dysfunction. No primary tissue failure of the prosthesis in any position was observed in the 357 patients aged 70 years or more at the time of valve implantation., Conclusions: The Carpentier-Edwards pericardial valve offers excellent clinical results and durability, particularly in the aortic position and for patients older than 70 years of age.

Background and Aims of the Study: The study aim was to assess the durability of the Carpentier-Edwards PERIMOUNT pericardial bioprosthesis in the mitral position., Methods: This seven-center retrospective clinical study involved the follow up of 333 patients who underwent isolated mitral valve replacement and 102 patients who underwent double (mitral and aortic) valve replacement with the PERIMOUNT pericardial valve between 1984 and 1989. Mean patient age at implant was 60.7 +/- 11.6 years; 41.1% were males. The most common etiology was rheumatic heart disease (53.9%) and the most common mechanism mitral insufficiency. All patients but six were followed for an average of 7.2 +/- 3.6 years after surgery; total follow up was 3071.7 patient-years (pt-yr)., Results: The total operative mortality rate was 7.6%; this included a valve-related mortality rate of 0.2%. The late mortality rate was 5.2% per pt-yr, of which 1.4% per pt-yr was considered valve-related. At 11 years, the overall actuarial survival rate was 53.3 +/- 2.8%, and actuarial freedom from valve-related death 83.9 +/- 2.6%. At follow up, 80% of patients were in NYHA class I or II, and 74% showed improvement. Twenty-eight incidences of deterioration requiring explant were observed. At 11 years the actuarial freedom from explant due to structural failure was 84.9 +/- 3.1%. Rates of structural failure decreased with age: the actuarial freedom from explant due to structural failure was 78.1 +/- 4.8% for patients aged < or = 60 years, 89.4 +/- 4.4% for those aged 61-70 years, and 100% for those aged over 71 years., Conclusion: The Carpentier-Edwards PERIMOUNT pericardial bioprosthesis is a reliable choice when a tissue valve is required, especially in patients over 60 years of age.

Background and Aim of the Study: The mechanism of valvular bioprostheses calcification is still unknown, but early studies showed increased Gla-protein content in calcified valves. Using an experimental model, which reproduces the clinical process, we therefore analyzed the role of minerals and proteins in bioprosthetic valvular calcification., Methods: Glutaraldehyde pretreated porcine valves were studied before and after implantation in rats by X-ray, calcium (Ca) and phosphorus (P) measurement, Fourier Transform Infrared (FTIR) spectroscopy, SDS-PAGE and 45Ca ligand blotting of the extracted proteins., Results: Before implantation, there was no X-ray calcification with very little Ca and P content. After implantation, X-ray calcifications appeared on day seven with increased Ca and P up to day 35 (p < 0.05, ANOVA). FTIR revealed structural proteins alone before implantation, plus minor proportions of lipids on day two, which always preceded Ca and P appearance. Ca and P increased up to day 35, first as amorphous and changed in carbapatite over time. SDS-PAGE before implantation revealed two proteins (66-kD and 54-kD) alone, which were sustained up to day 35. The 66-kD had 45Ca affinity. On day two, many other proteins appeared on SDS-PAGE, four of which (52, 45, 14 and below 14-kD) with 45Ca affinity. Protein pattern did not change from day two to 35., Conclusions: Valvular bioprosthesis calcification is associated with progressive increase in Ca and P content and at least five calcium-binding proteins: one intrinsic valvular protein, pre-existing to implantation, plus four other, extrinsic valvular proteins adsorbed within the tissue after implantation.

Aortic valve replacement with Carpentier-Edwards pericardial bioprosthesis was associated with excellent midterm clinical results. Long-term evaluation, however, remained to be determined. We reviewed the first 124 patients who underwent aortic valve replacement with a Carpentier-Edwards bioprosthesis at the Hôpital Broussais between 1980 and 1985. There were 67 males (54%) and 57 females (46%). The mean age at operation was 65 years (range, 18-83 years). The operative mortality (30 days) was 4%. All but 2 patients were followed up for an average of 7.7 years and a total of 973 patient years. There were 45 late deaths (4.7%/patient-year) of which 16 were valve-related (1.7%/patient-year). The actuarial survival rate was 49.9% at 12 years. The actuarial rate for freedom from valve-related mortality was 78.3% at 12 years. There were 7 thromboembolic events in 5 patients and 3 anticoagulation-related hemorrhages. Freedom from structural valve deterioration was 100% at 12 years and 83.3% at 13 years. We conclude that implantation of Carpentier-Edwards pericardial bioprosthesis in aortic position is associated with an excellent long-term clinical outcome. It is believed that the improved results of this valve result from the following original features: fully flexible stent, distensible struts, infrastent tissue mounting, optimal tissue orientation, and improved preservation.

Surgical treatment of valvular heart disease is a field of constant clinical and experimental research. Recently, much attention has been devoted to the improvement of valve repair techniques. The physiopathology of the left ventricular outflow tract obstruction following mitral valve repair has become better understood. Surgical techniques to correct this infrequent complication have been developed. Conservative valvular surgery or homograft use are among the surgical treatments for infective endocarditis; innovative experimental and clinical studies on mitral and tricuspid homografts have provided interesting results. New biological valves have come into use; intraoperative creation of a cardiac bioprosthesis using glutaraldehyde-treated autologous pericardium is an attractive surgical innovation. Stentless bioprostheses are also under investigation, to evaluate their hemodynamic and clinical characteristics. The biology of bioprosthesis deterioration progresses at the cellular level, with the implication of phagocytosis as a contributing factor.