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Objectives: Aortic valve replacement (AVR) using a bioprosthesis remains controversial for patients aged 50-65 years. This cohort study reports the very long-term outcomes of AVR using Carpentier-Edwards Perimount pericardial bioprosthesis in this age group., Methods: From 1984 to 2008, 522 Carpentier-Edwards Perimount pericardial aortic bioprostheses were implanted in 516 patients aged 50-65 years (mean age, 60 ± 4 years; 19% female). Multiple valve replacements were excluded fro m our cohort. Baseline demographic, perioperative and follow-up data were recorded prospectively. Mean follow-up was 9 ± 6 years, for a total of 4428 valve-years. Follow-up was complete for 97% of patients included., Results: Operative mortality rate was 2%. One hundred and forty-six late deaths occurred for a linearized rate of 3%/valve-year. Actuarial survival rates averaged 73 ± 2, 59 ± 3 and 35 ± 5% after 10, 15 and 20 years of follow-up, respectively. Mortality rate associated with reoperation was 2%. Actuarial freedom from reoperation rates due to structural valve deterioration (SVD) at 10, 15 and 20 years was respectively of 91 ± 2, 76 ± 3 and 50 ± 6%. Competing risk analysis demonstrated an actual risk of explantation secondary to SVD at 20 years of 30 ± 3%. Expected valve durability was 19 years for this age group. Age was not a significant risk factor for SVD in this middle-aged population., Conclusions: In patients aged 50-65 years undergoing AVR with the Carpentier-Edwards Perimount bioprosthesis, the expected valve durability was 19 years. Age was not a significant risk factor for SVD within this age group. Patient selection and attention to timing of reintervention may be determinants of long-term outcomes., (© The Author 2015. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)

Background: Aortic valve replacement using a bioprosthesis remains controversial for patients younger than 60 years because of missing data on long-term outcomes in this age group., Methods: From 1984 to 2008, 383 Carpentier-Edwards Perimount pericardial aortic bioprostheses were implanted in 373 patients 60 years or younger (mean age, 51.0 ± 9.2 years; 19% female). Multiple valve replacements were excluded from our cohort. Baseline clinical, perioperative, and follow-up data were recorded prospectively. The mean follow-up was 8.6 ± 5.9 years, for a total of 3,299 valve-years. Follow-up was complete for 95.3% of patients included., Results: Operative mortality rate was 1.3%. Eighty-five late deaths occurred, for a linearized rate of 2.6%/valve-year. Actuarial survival rates averaged 78.1% ± 2.6%, 65.6% ± 3.5%, and 46.8% ± 6.0% after 10, 15, and 20 years of follow-up, respectively. Mortality rate associated with reoperation was 2.3%. Actuarial freedom from reoperation rates attributable to structural valve deterioration at 10, 15, and 20 years were, respectively, 88.3% ± 2.4%, 70.8% ± 4.1%, and 38.1% ± 5.6%. Competing risk analysis demonstrated an actual risk of explantation secondary to structural valve deterioration at 20 years of 41.6% ± 4.1%. Expected valve durability was 17.6 years for this age group., Conclusions: In selected patients 60 years or younger undergoing aortic valve replacement with the Carpentier-Edwards Perimount bioprosthesis, the expected valve durability was 17.6 years. Reoperation for structural valve deterioration was associated with a low risk of mortality., (Copyright © 2015 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Background: The Carpentier-Edwards Perimount pericardial bioprosthesis (Edwards Lifesciences, Irvine, CA) has demonstrated good long-term outcomes, but its durability remains unclear depending on age at implantation. We report our 20-year experience with the Perimount valve implanted in the aortic position, with particular attention to the probability and time to reoperation required due to bioprosthesis deterioration., Methods: From 1984 to 2008 at our center, 2,659 patients (mean age, 70.7 ± 10.4 years) underwent aortic valve replacement using the Perimount pericardial bioprostheses. Patients were prospectively followed on an annual basis (mean 6.7 ± 4.8 years, range 0 to 24.6 years) with an echocardiogram at the time of follow-up. Cumulative follow-up was 18,404 valve-years. Bioprosthesis structural valve deterioration was determined by strict echocardiographic assessment., Results: Overall operative mortality was 2.8%. Actuarial survival rates including early deaths averaged 52.4% ± 1.2%, 31.1% ± 1.4%, and 14.4% ± 1.7% after 10, 15, and 20 years of follow-up, respectively. Age-stratified freedom from reoperation due to structural valve deterioration at 15 and 20 years was 70.8% ± 4.1% and 38.1% ± 5.6%, respectively, for the group aged 60 years or less, 82.7% ± 2.9% and 59.6% ± 7.6% for those 60 to 70 years, and 98.1% ± 0.8% at 15 years and above for the oldest group. Expected valve durability is 19.7 years for the entire cohort., Conclusions: With a low rate of valve-related events at 20 years, and particularly a low rate of structural valve deterioration, the Carpentier-Edwards Perimount pericardial bioprosthesis remains a reliable choice for a tissue valve in the aortic position, especially in patients over 60 years of age., (Copyright © 2015 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Objective: The aim of the present study was to evaluate the very-long-term results of the Carpentier-Edwards pericardial bioprosthesis in the mitral position., Methods: From 1984 to 2011, 450 Carpentier-Edwards PERIMOUNT pericardial mitral bioprostheses were implanted in 404 consecutive patients (mean age, 68 years; 53% female). Patients undergoing multiple valve replacements were excluded. The clinical, operative, and follow-up data were prospectively recorded. The mean follow-up was 7.2±5.1 years, for a total of 3258 valve-years. The follow-up data were 97.8% complete., Results: The operative mortality rate was 3.3%. A total of 188 late deaths occurred, for a linearized rate of 5.8%/valve-year. At 20 years, the overall actuarial survival rate was 16.9%±3.9%. Age at implantation, preoperative New York Heart Association class III or IV, and redo procedure were significant risk factors affecting late survival. The actuarial freedom from complications at 20 years was thromboembolism, 83.9%±7.6%; hemorrhage, 80.2%±10.8%; endocarditis, 94.8%±1.4%; structural valve deterioration, 23.7%±6.9%; and explantation owing to structural valve deterioration, 40.5%±8.0%. The competing risk analysis demonstrated an actual risk of explantation owing to structural valve deterioration at 20 years of 25.5%±2.9%. The expected valve durability was 16.6 years for the entire cohort (11.4, 16.6, and 19.4 years for patients aged <60, 60 to 70, and >70 years, respectively)., Conclusions: With a low rate of valve-related events at 20 years and, in particular, a low rate of structural valve deterioration, the Carpentier-Edwards PERIMOUNT pericardial bioprosthesis remains a reliable choice for a mitral tissue valve, especially in patients >60 years old., (Copyright © 2014 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.)

Data of 401 patients who underwent mitral valve replacement with the Carpentier-Edwards Perimount bioprosthesis between 1984 and 2009 were evaluated. Their mean age was 68.1 ± 10.4 years (range, 22-90 years) and 54.9% were female. The most common etiology was degenerative disease (33.2%) and 62.1% of patients had mitral insufficiency. Follow-up was 3,178 patient-years, and 96.8% complete; the mean follow-up was 8.9 ± 3.1 years. Overall survival at 25 years was 10.2% ± 3%. Late mortality was 2.48% per patient-year, and valve-related deaths occurred at 1.62% per patient-year. The actuarial freedom from reoperation due to structural valve deterioration at 20 years was 24.3% ± 2% for degenerative disease and 15% ± 1.4% for non-degenerative disease. For degenerative valve disease, the freedom from structural valve deterioration at 18-years was 39% ± 1% for recipients <60-years old and 66% ± 2% for those ≥60-years old. Our data confirm the excellent durability and low mortality associated with the Carpentier-Edwards Perimount for mitral valve replacement. The rate of calcification of the valve was unrelated to degenerative valve disease, but our findings suggest that this prosthesis gives better results in recipients ≥60-years old than in younger patients.

A 65-year-old patient presented with recurrent cardiac decompensation 12 years after aortic prosthesis replacement and expanded polytetrafluoroethylene (ePTFE) membrane pericardial substitution. Diagnosis of pericardial constriction was difficult. Only one cardiac imaging method, radionuclide ventriculography, was helpful. Upon re-operation, an epicardial fibrous strap which restricted right ventricle (RV) diastolic expansion was found between the anterior free wall and diaphragmatic portion of the RV. Clinical status dramatically improved after surgical removal of this bridle, as did ventricular filling curves in radionuclide imaging. This case shows that delayed cardiac constriction is possible after ePTFE pericardial substitution, especially if the membrane is applied to both anterior and diaphragmatic aspects of the heart., (2010 Published by European Association for Cardio-Thoracic Surgery. All rights reserved.)

Background and Aim of the Study: Aortic stenosis (AS) is the most important cause of aortic valve disease, its prevalence increasing with patient age. The present study formed part of a long-term evaluation on use of the Perimount pericardial valve for aortic calcified stenosis., Methods: A total of 1133 consecutive patients who underwent aortic valve replacement (AVR) with a Perimount pericardial bioprosthesis for degenerative AS between July 1984 and December 2003 at the authors' institution, was followed up in 2004. Among the patients (716 males, 417 females; mean age 72.6 years), 997 were in sinus rhythm, and the mean NYHA functional class was 2.3. Preoperative echocardiography indicated a mean gradient of 56 mmHg, a peak gradient of 89 mmHg, and an effective orifice area of 0.6 cm2. Associated procedures were required in 336 patients., Results: All patients but 18 (1.5%) were followed up for an average of 5.5 years postoperatively; thus, the total follow up was 6,180 patient-years. Operative mortality was 2.8% (n=32), and there were 330 late deaths. At 18 years the actuarial survival rate was 22 +/- 4%. Among the 725 patients followed, 80% were in sinus rhythm and 98% in NYHA classes I or II. Valve-related complications included 39 thromboembolic episodes, 24 endocarditis, 22 anticoagulant-related hemorrhage, 28 reoperations, and 19 structural valve failures. A total of 54 patients died from valve-related causes (13 embolic events, two endocarditis, two hemorrhage, one structural failure, 36 unknown causes), and 57 died from cardiac failure. Neither thrombosis nor hemolysis was observed. At 18 years, freedom from embolism was 92 +/- 2%, from endocarditis 93 +/- 4%, from hemorrhage 95 +/- 2%, from reoperation 62 +/- 11%, from valve failure 68 +/- 12%, and from all complications 47 +/- 8%. Among patients aged >60 years, the 18-year actuarial freedom from reoperation was 76 +/- 14%, and from valve failure 85 +/- 8%., Conclusion: With a low rate of valve-related events at 18 years, and an especially low rate of structural failure, the Perimount pericardial prosthesis is a reliable choice for patients with aortic calcified stenosis.

The second-generation Carpentier-Edwards bioprostheses, the supra-annular porcine valve and the PERIMOUNT pericardial valve, have been evaluated longitudinally for several years. This study compared clinical performance over 15 years. Aortic valve replacement was performed with a supra-annular porcine valve in 1,823 patients (group 1) aged 19-89 years (mean, 68.9 +/- 10.9 years) and with a PERIMOUNT pericardial bioprosthesis in 1,430 patients (group 2) aged 16-90 years (mean, 69.5 +/- 10.4 years). The groups were similar except for concomitant coronary artery bypass in 43% of group 1 and 18% of group 2 ( p < 0.001). Overall survival at 15 years was 29.3% +/- 1.5% for group 1 and 35.2% +/- 3.1% for group 2 ( p = 0.0009). The actual freedom from valve-related mortality was 88.5% +/- 0.9% for group 1 and 84.9% +/- 1.7% for group 2. The actual freedom from structural valve deterioration at 15 years was similar overall, and for patients aged > 60 years, between the groups, but was dissimilar (group 2 > group 1) for age group 2), sex (male > female), age, and concomitant coronary artery bypass. Both bioprostheses provided satisfactory clinical performance at 15 years after aortic valve replacement.