Bovine Pericardial Bioprosthesis Research Articles

Five-year outcomes of surgical aortic valve replacement with a novel bovine pericardial bioprosthesis.

The short-term performance of the Cingular bovine pericardial aortic valve was proven. This study evaluated its 5-year safety and haemodynamic outcomes. It enrolled 148 patients who underwent surgical aortic valve replacement with the Cingular bovine pericardial aortic valve between March 2016 and October 2017 in 5 clinical centres in China. Safety and haemodynamic outcomes were followed up to 5 years. The incidence of all-cause mortality, structural valve deterioration and reintervention was estimated by Kaplan-Meier analysis. The mean age of patients was 67.7 [standard deviation (SD) 5.1] years, and 36.5% of patients were female. The mean follow-up was 5.3 (SD 1.2) years. Five-year freedom from all-cause mortality, structural valve deterioration and all-cause reintervention were 91.2%, 100% and 99.3%, respectively. At 5 years, the mean gradient and effective orifice area of all sizes combined were 14.0 (SD 5.5) mmHg and 1.9 (SD 0.3) cm2, respectively. For 19- and 21-mm sizes of aortic prostheses, the mean gradients and effective orifice area at 5 years were 17.5 (SD 7.0) mmHg and 1.6 (SD 0.2) cm2 and 13.7 (SD 6.7) mmHg and 1.8 (SD 0.3) cm2, respectively. The incidence of moderate or severe patient-prosthesis mismatch was 4.1% and 0.0% patients at 5 years, respectively. The 5-year safety and haemodynamic outcomes of Cingular bovine pericardial aortic valve are encouraging. Longer-term follow-up is warranted to assess its true durability.

A Controlled Trial Comparing One-Year Hemodynamics of Two Bovine Pericardial Valves.

This randomized controlled trial was designed to compare 1-year hemodynamic performances and clinical outcomes after aortic valve replacement (AVR) using a recently introduced (the AVALUS group) and worldwide used (the CEPME group) bovine pericardial bioprostheses. Patients were screened to enroll 70 patients in each group based on a noninferiority design. The primary endpoint of the trial was the mean pressure gradient across the aortic valve (AVMPG) at 1 year after surgery. One-year echocardiographic data were obtained from 92.1% (129 of 140 patients) of the study patients. There were no differences in baseline characteristics, including sex and body surface area (1.64 ± 0.18 vs. 1.65 ± 0.15 m2) between the groups. The AVMPG on 1-year echocardiography was 14.0 ± 4.3 and 13.9 ± 5.1 mmHg in the AVALUS and CEPME groups, respectively (the p-value for noninferiority was 0.0004). In the subgroup analyses for the respective size of the prostheses, AVMPG of the 19-mm prostheses was significantly lower in the AVALUS group than in the CEPME group (14.0 ± 4.3 vs. 20.0 ± 4.7 mmHg, p = 0.012), whereas those of the other sizes were not significantly different between the two groups. There were no significant differences in the effective orifice area (1.49 ± 0.40 vs. 1.53 ± 0.38 cm2, p = 0.500) or effective orifice area index (0.91 ± 0.22 vs 0.93 ± 0.23 cm2/m2, p = 0.570) in all the patients, or in the subgroup analysis for the 19-mm prosthesis. There were no differences in the 1-year clinical outcomes between the two groups. The 1-year hemodynamic and clinical outcomes of the AVALUS group were noninferior to those of the CEPME group (NCT03796442).

Bovine pericardial versus porcine bioprosthetic aortic valves: A nationwide population-based cohort study in Korea

ObjectiveTo compare the clinical outcomes of aortic valve replacement (AVR) using bovine pericardial and porcine bioprostheses, utilizing a nationwide administrative claims database. MethodsAdult patients (age ≥40 years) who underwent bioprosthetic AVR, without other valve replacements, between 2003 and 2018 were identified from the Korean National Health Insurance Service database. The outcomes of interest were all-cause mortality, cardiac mortality, and valve-related events, including the incidence of reoperation, endocarditis, systemic thromboembolism, and major bleeding. Baseline adjustment was performed using propensity score matching. Time-related outcomes were evaluated using a competing risk analysis, with death as a competing risk. ResultsAmong the 7714 patients who underwent bioprosthetic AVR, 5621 (72.9%) received bovine pericardial prostheses and 2093 (27.1%) received porcine bioprostheses. After matching, 1937 pairs were included in the final analysis. During follow-up (median, 4.49 years; interquartile range, 2.83-8.20 years), the use of porcine bioprostheses was associated with a higher risk of aortic valve reoperation (adjusted hazard ratio [HR], 1.87; 95% confidence interval [CI], 1.16 to 3.01); however, no significant differences were observed in cumulative incidences of all-cause mortality, cardiac mortality, thromboembolism, or major bleeding. Subgroup analyses revealed that the use of bovine valves was associated with improved survival in patients with diabetes mellitus, whereas in patients undergoing dialysis, porcine valves exhibited better survival than bovine valves. ConclusionsIn this large nationwide cohort study of patients undergoing bioprosthetic aortic valve replacement, the use of porcine prostheses was significantly associated with an increased risk of reoperation compared with the use of bovine prostheses, supporting previous findings.

Durability of bovine pericardial mitral bioprosthesis based on Heart Valve Collaboratory echocardiographic criteria

ObjectiveThis study evaluated the very long-term results of the Carpentier-Edwards pericardial bioprosthesis in the mitral position, with particular attention to structural valve deterioration based on echocardiographic criteria. MethodsFrom 1984 to 2016, 648 patients (mean age 68.8 years; 53.9% female) underwent mitral valve replacement using the Carpentier-Edwards PERIMOUNT pericardial bioprosthesis. Multiple valve replacements were excluded. Clinical, operative, and follow-up data were prospectively recorded. The mean follow-up was 7.8 ± 5.4 years, for a total of 5043 valve-years. The follow-up data were 98.3% complete (11 patients lost). Structural valve deterioration was determined by strict echocardiographic assessment based on Heart Valve Collaboratory criteria. ResultsOperative mortality was 4%. A total of 322 late deaths occurred, for a linearized rate of 6.4%/valve-year. The actuarial survival rate at 15 years was 31.4 ± 2.6%. Age at implantation, male sex, and preoperative New York Heart Association class III or IV were significant risk factors affecting late survival. Actuarial freedoms from complications at 15 years were thromboembolism, 92.5 ± 1.9%; major bleeding, 93.8 ± 1.7%; endocarditis, 93.2 ± 1.3%; and explantation due to structural valve deterioration, 69.3 ± 3.5%. The median survival time for explantation due to structural valve deterioration was 21.7 years for the entire cohort (16.1 years for patients <65 years old). Based on echocardiographic data, actuarial freedom from severe and moderate/severe structural valve deterioration at 15 years were 64.0 ± 3.6% and 52.1 ± 3.6%, respectively. ConclusionsWith low 15-year rates of valve-related events and structural valve deterioration based on Heart Valve Collaboratory echocardiographic criteria, the Carpentier-Edwards PERIMOUNT pericardial bioprosthesis remains a reliable choice for a mitral tissue valve.

Budget impact analysis of a bovine pericardial aortic bioprosthesis versus mechanical aortic valve replacement in adult patients with aortic stenosis in Romania

AimsAn analysis of the budget impact of using a bovine pericardial aortic bioprosthesis (BPAB) or a mechanical valve (MV) in aortic stenosis (AS) patients in Romania.Materials and methodsA decision-tree with a partitioned survival model was used to predict the financial outcomes of using either a BPAB (the Carpentier-Edwards Perimount Magna Ease Valve) or MV in aortic valve replacement (AVR) procedure over a 5-year period. The budget impact of various resource consumption including disabling strokes, reoperations, minor thromboembolic events, major bleeding, endocarditis, anticoagulation treatment and monitoring, and echocardiogram assessments were compared for both types of valves. One-way sensitivity analyses (OWSA) were conducted on the input costs and probabilities.ResultsThe use of BPAB compared to MV approaches budget neutrality due to incremental savings year-on-year. The initial surgical procedure and reoperation costs for BPAB are offset by savings in acenocoumarol use, disabling strokes, major bleeding, minor thromboembolic events, and anticoagulation complications. The cost of the initial procedure per patient is 460 euros higher for a BPAB due to the higher valve acquisition cost, although this is partially offset by a shorter hospital stay. The OWSA shows that the total procedure costs, including the hospital stay, are the primary cost drivers in the model.LimitationsResults are limited by cost data aggregation in the DRG system, exclusion of costs for consumables and capital equipment use, possible underestimation of outpatient complication costs, age-related variations of event rates, and valve durability.ConclusionsAdopting BPAB as a treatment option for AS patients in Romania can lead to cost savings and long-term economic benefits. By mitigating procedure costs and increasing anticoagulation treatment costs, BPAB offers a budget-neutral option that can help healthcare providers, policymakers, and patients alike manage the growing burden of AS in Romania.

Bovine pericardial versus porcine bioprosthetic mitral valves: results from a Korean Nationwide Cohort Study.

Comparisons of long-term clinical outcomes of mitral valve replacement (MVR) between bovine pericardial and porcine bioprostheses are conflicting, with limited research in large-scale real-world clinical settings. This study examined clinical outcomes in MVR according to bioprosthesis type using a national administrative claims database. This study included adult patients undergoing bioprosthetic MVR between 2003 and 2018 using administrative health care data from the Korean National Health Insurance Service database. Propensity score matching with competing risk analysis was used to compare the clinical outcomes according to the type of bioprosthesis. The end points were death, cardiac death, and valve-related events, including the incidence of reoperation, endocarditis, systemic thromboembolism, and major bleeding. A total of 3151 patients underwent bioprosthetic MVR with bovine pericardial (n = 1628, 51.7%) or porcine (n = 1523, 48.3%) bioprostheses. After matching, 1170 pairs were included in the final analysis. During follow-up (median 4.49 years, interquartile range 1.87 -8.75 years), death occurred in 1178 patients (6.8%/patient-year), comprising 730 (4.3%/patient-year) cardiac death. No significant differences were noted between the bovine and porcine groups in the cumulative incidences of death from any cause [adjusted hazard ratio (aHR), 1.00; 95% confidence interval (CI), 0.87-1.14], cardiac mortality (aHR, 0.96; 95% CI, 0.81-1.14), or reoperation (aHR, 1.01; 95% CI, 0.72-1.41). This study on a nationwide comparison between bovine and porcine bioprostheses in MVR found no significant differences in clinical outcomes including mortality, and valve-related reoperation.

Externally mounted versus internally mounted leaflet aortic bovine pericardial bioprosthesis: meta-analysis.

Recent studies reported higher-than-expected rates of early structural valve degeneration (SVD) and/or reoperation of externally mounted leaflet aortic bioprosthesis compared with others. This meta-analysis aims to compare the outcomes of bioprostheses with externally versus internally mounted leaflet design in patients who underwent surgical aortic valve replacement (SAVR). MEDLINE and EMBASE were searched through November 2021 to identify comparative studies investigating outcomes following SAVR with either externally or internally mounted leaflet aortic bioprosthesis. Outcomes of interest were reoperation for SVD or any cause and all-cause mortality. Our analysis included 15 observational studies that enrolled a total of 23,539 patients who underwent SAVR using externally mounted (n = 9338; 39.7%) or internally mounted leaflet (n = 14,201; 60.3%) bioprostheses. Externally mounted valves consisted of the Trifecta (Abbott, St Paul, MN) (n = 6146) and the Mitroflow (LivaNova, London, UK) (n = 3192), and all internally mounted valves were the Perimount (Edwards Lifesciences, Irvine, CA). Externally mounted valves compared with the Perimount were associated with higher reoperation rates for SVD [hazard ratio (HR) 3.55, 95% confidence interval (CI) 2.67-4.72; P < 0.001] and any cause (HR 9.36, 95% CI 3.70-23.67; P < 0.001). Furthermore, externally mounted valves demonstrated higher all-cause mortalities (HR 1.33, 95% CI 1.13-1.56; P < 0.001). The present study summarizing updated evidence revealed higher reoperation rates and all-cause mortalities in patients with externally mounted leaflet aortic bioprostheses compared with those with internally mounted design. Choosing the right SAVR valve type is critical part of lifetime management of aortic valve disease.

Durability of a bovine pericardial aortic bioprosthesis based on Valve Academic Research Consortium-3 echocardiographic criteria

ObjectivesThe Carpentier-Edwards Perimount Magna Ease (Edwards Lifesciences) pericardial bioprosthesis has demonstrated satisfying hemodynamics at midterm follow-up, but its durability remains unclear. We report our 10-year experience with this third-generation valve implanted in the aortic position, with particular attention to structural valve deterioration. MethodsFrom 2007 to 2016 at our center, 338 patients underwent aortic valve replacement using the Perimount Magna Ease pericardial bioprosthesis. Patients were prospectively followed (mean 6.6 ± 2.6 years) with clinical evaluation and yearly echocardiography. Follow-up was 98% complete (7 patients lost) for a total of 2238 valve-years. Bioprosthesis structural valve deterioration was determined by strict echocardiographic assessment based on the Valve Academic Research Consortium 3 criteria. ResultsOverall operative mortality was 1.2%. Actuarial survival including early deaths averaged 80.9% ± 2.2% and 66.7% ± 4.4% after 5 and 10 years of follow-up, respectively. Actuarial freedom from explantation due to structural valve deterioration at 5 and 10 years was 99.6% ± 0.4% and 88.8% ± 5.0%, respectively, and actuarial freedom of structural valve deterioration at 5 and 10 years was 98.5% ± 0.7% and 44.0% ± 6.4%, respectively. More precisely, actuarial freedom of structural valve deterioration stage 3 was 99.6% ± 0.4% at 5 years and 88.3% ± 5.0% at 10 years, whereas freedom of structural valve deterioration stage 2/3 was 98.5% ± 0.7% and 60.9% ± 7.0%, respectively. ConclusionsWith a low rate of explantation due to structural valve deterioration events at 10 years, and particularly a low rate of moderate or severe structural valve deterioration based on echocardiographic Valve Academic Research Consortium 3 criteria, the Carpentier-Edwards Perimount Magna Ease pericardial bioprosthesis remains a reliable choice for a tissue valve in the aortic position. Video Abstract [Display omitted]

Five-year Outcomes of the COMMENCE Trial Investigating Aortic Valve Replacement With RESILIA Tissue

BackgroundThe COMMENCE trial was conducted to evaluate the safety and effectiveness of aortic valve replacement using a bioprosthesis with novel RESILIA tissue (Edwards Lifesciences). RESILIA tissue is incorporated in the INSPIRIS RESILIA aortic valve (Edwards Lifesciences). MethodsPatients underwent clinically indicated surgical aortic valve replacement with a bovine pericardial bioprosthesis (model 11000A; Edwards Lifesciences) in a prospective, multinational, multicenter (n = 27), US Food and Drug Administration Investigational Device Exemption trial. Events were adjudicated by an independent clinical events committee, and echocardiograms were analyzed by an independent core laboratory. Outcomes through an observational period of 5 years are reported. ResultsBetween January 2013 and March 2016, 689 patients received the study valve. Mean patient age was 66.9 ± 11.6 years; Society of Thoracic Surgeons Predicted Risk of Mortality was 2.0% ± 1.8%; and 23.8%, 49.9%, and 24.4% of patients were New York Heart Association functional class I, II, and III at baseline, respectively. Through December 11, 2020 the follow-up duration was 4.3 ± 1.4 years, and the completeness of follow-up over the observational period was 95.5%. Early (<30 days) all-cause mortality was 1.2%, stroke 1.6%, and major paravalvular leak 0.1%. Five-year actuarial freedom from all-cause mortality, structural valve deterioration, and all-cause reintervention were 89.2%, 100%, and 98.7%, respectively. At 5 years the effective orifice area was 1.6 ± 0.5 cm2, mean gradient was 11.5 ± 6.0 mm Hg, 97.8% of patients were class I/II, and 97.8% and 96.3% of patients had none/trace paravalvular and transvalvular regurgitation, respectively. ConclusionsThe safety and hemodynamic performance of this aortic bioprosthesis with RESILIA tissue through 5 years are encouraging, with clinically stable hemodynamics, minimal regurgitation, and no evidence of structural valve deterioration.

Comparison of porcine versus bovine pericardial bioprosthesis in the mitral position.

There are no reports of midterm outcomes after mitral valve replacement with a 25-mm bioprosthesis in a large series of patients. This study aimed to examine perioperative and midterm outcomes of bioprosthetic valve choice, porcine or bovine pericardial, in the mitral position, focusing on 25-mm valves. From 2007 to 2018, 467 patients received a mitral bioprosthesis, with or without concomitant procedures. Of these, 111 (23.8%) were porcine, and 356 (76.2%) were bovine pericardial, and 219 patients (46.9%) received a 25-mm valve. A propensity-matched cohort of 192 patients was used for outcome analyses. The influence of the valve type on midterm survival and incidence of cardiac death was assessed. Similarly, subanalysis stratified by valve size was conducted. In matched patients, there were no differences in midterm survival and incidence of cardiac death between the two groups (log-rank test; p = .268 and p = .097, respectively). There were no differences in midterm survival and incidence of cardiac death between the 25-mm valve and larger valve (log-rank test; p = .563 and p = .597, respectively). The Cox proportional-hazards model revealed that the valve type and 25-mm valve did not affect midterm survival (p = .487 and p = .375, respectively) and incidence of cardiac death (p = .678 and p = .562, respectively). The choice of a porcine or bovine pericardial bioprosthesis does not affect midterm survival and cardiac death. The 25-mm valves, whether bovine or porcine, could be an appropriate alternative when the patient's body size is small.

A single-center 14-year follow-up study of the BalMedic® bovine pericardial bioprosthetic valve.

BackgroundThe causes of valvular disease in China are complex, with a broad age distribution. For patients with early mechanical valve replacement, the quality of life is affected by postoperative anticoagulation-related complications. Since 2005, we have used bioprosthetic valves to provide more options for patients. In this study, we retrospectively analyzed the 14-year follow-up data of patients undergoing BalMedic bovine pericardial bioprosthetic valve replacement (manufacturer: Beijing Balance Medical Tech Co., Ltd.) to evaluate its intermediate- to long-term clinical effectiveness.MethodsFrom 2005 to 2014, 336 BalMedic pericardial bioprosthesis valves were implanted in 299 patients (mean age 53.5 years, 59.86% female) at The First People’s Hospital of Yulin. Among followed up 290 discharged patients, 284 underwent aortic valve replacement and mitral valve replacement (AVR group, MVR group) for further grouping analysis, 6 underwent tricuspid valve replacement (TVR). The mean follow-up was 7.7±2.5 years (5 to 14), for a total of 2,196 valve-years, 98.28% of the patients completed follow-up.ResultsThe perioperative mortality was 3% (9/299). After discharge, 68 patients (23.4%, 68/290) died, and 36 (12.4% 36/290) underwent the second valve replacement. The overall 5- and 10-year survival rates were 89.95% and 72.53%, respectively. For patients undergoing AVR alone, the overall 10-year survival rates were 80.64%, the reoperation-free rates were 92.94%, and the SVD-free rates were 90.95%. For patients undergoing MVR and double valve replacement (DVR group), the 10-year survival rates were 67.21% and 82.90%, the reoperation-free rates were 72.26% and 73.33%, the SVD-free rates were 58.90% and 53.80%, respectively. Subgroup analysis by age showed no significant intergroup difference in overall survival but a significant intergroup difference in reoperation-free and SVD-free rates (P<0.05).ConclusionsWith a similar 10-year overall survival rate as its foreign counterparts, BalMedic bovine pericardial bioprosthesis is reliable choice for both aortic valve and mitral valve. In patients undergoing AVR, the BalMedic valve is superior to the similar foreign counterparts in overall survival, reoperation-free survival, and SVD-free rates. While in MVR or DVR, Chinese patients are younger because of different etiology, postoperative outcomes show non-inferior to those from the foreign counterparts.

1645 Unexpected aortic bioprosthetic valve thrombosis

Abstract Introduction Prosthetic valve thrombosis (PVT) is a rare but feared complication of cardiac valve replacement which usually represents a difficult diagnostic challenge. Although PVT is not frequent in bioprosthetic valves, the advent of transcatheter heart valves and the advances in computed tomography, allowing the detection of subclinical thrombosis, have yielded growing interest in that field, specially taking into account that there is no consensus on optimal antithrombotic approach in these patients. Clinical Case A 74-year-old male with prior cardiac antecedents of aortic valve replacement (April 2010) with a bovine pericardial bioprosthesis (Mitroflow 25, Sorin group Inc.), ischemic dilated cardiomyopathy with moderately depressed left ventricle ejection fraction (33%) and carrier of VDD pacemaker due to third degree atrioventricular block was admitted to advanced heart failure unit. During routine follow-up echocardiograms, prosthetic valve presented no signs of dysfunction except slightly increased gradients (image C): max 38 mmHg (normal &amp;lt;36), med 23 mmHg (normal &amp;lt;20). Because of left ventricle dysfunction, high pacing rate (&amp;gt;95%) and dyspnea NYHA class III the patient was referred for upgrade to cardiac resynchronization therapy (CRT). Computed tomography to asses epicardial venous anatomy prior to CRT implant was performed. In addition to venous distribution, it was described a repletion defect in aortic bioprosthetic valve suggestive of leaflet thrombosis (image A). To complete the study the patient underwent a transesophageal echocardiography (TOE) revealing a swallow’s nest shaped hypoechoic occupation of non-coronary and left aortic leaflets (image B), and 3D effective orifice area of 0,9 cm2. Oral anticoagulation was started in association to previously taken acetylsalicylic acid (ASA). Control TOE was performed 3 months after diagnosis showing almost complete resolution of thrombi. During the follow-up a CRT-D was implanted, with significant response in systolic performance, reaching a LVEF of 45%. Interestingly, despite the increase in anterograde aortic flow, progressive decrease of aortic gradients (max 24 mmHg, med 15 mmHg) until normalization was found (image D). Clinical benefit was also patent, being the patient in NYHA class I at the moment. Discusion Valve thrombosis could be difficult to diagnose in the presence of left ventricle dysfunction as gradients shall remain low despite an important compromise in valve motion. We present a case of incidental diagnosis of non-obstructive leaflet thrombosis that was managed conservatively with oral anticoagulation and ASA. The descent in transaortic gradients, moreover taking into account the response to CRT increasing LVEF, indicates that gradients slightly increased or in the upper limit of normality should raise suspicion in valve dysfunction in the presence of decreased LVEF. Abstract 1645 Figure.

One-year outcomes associated with a novel stented bovine pericardial aortic bioprosthesis

ObjectivesThe study objectives were to evaluate the safety, effectiveness, and hemodynamic performance of a new stented bovine pericardial aortic valve. MethodsThis trial enrolled patients with symptomatic moderate or severe aortic stenosis or chronic, severe aortic regurgitation. We assessed death, valve-related adverse events, functional recovery, and hemodynamic performance at discharge, 3 to 6 months, and 1 year, as required by the US Food and Drug Administration for regulatory approval. The primary analysis compared late linearized rates of valve-related adverse events after implantation with Food and Drug Administration–specified objective performance criteria to determine whether the adverse event rates associated with the valve are within acceptable limits. Adverse events included thromboembolism, thrombosis, all and major hemorrhage, all and major paravalvular leak, and endocarditis. ResultsThe primary analysis included 864 patients who received an implant and 904.1 valve-years of follow-up. A total of 577 patients completed the 1-year evaluation. The primary end point was met for death, thromboembolism, thrombosis, all and major paravalvular leak, and endocarditis, but not for all and major hemorrhage. At 1 year, freedom from all death and from valve-related death was 96.4% and 99.7%, respectively. From baseline to 1 year, New York Heart Association class changed as follows: I, 10.8% to 73.7%; II, 48.9% to 22.6%; III, 38.0% to 3.5%; and IV, 2.3% to 0.2%. Effective orifice area increased from 0.9 ± 0.5 to 1.5 ± 0.4 (P < .0001), and mean aortic gradient decreased from 42.7 ± 16.5 to 12.5 ± 4.3 (P < .0001). ConclusionsThis analysis of a new stented bovine pericardial aortic valve demonstrated low overall mortality and valve-related adverse events, and hemodynamic performance comparable to that of other surgical aortic valves.

Long-Term Clinical Outcomes of the Carpentier-Edwards Perimount Pericardial Bioprosthesis in Chinese Patients with Single or Multiple Valve Replacement in Aortic, Mitral, or Tricuspid Positions

Objectives: To report the safety and efficacy results of a 9- to 15-year follow-up investigation among patients who had received Carpentier-Edwards Perimount (CE-P) bovine pericardial bioprostheses (Edwards Lifesciences, Irvine, CA, USA) for valve replacement. Methods: This retrospective study investigated freedom from structural valve deterioration (SVD) as well as survival and reoperation among different age and etiology groups in patients who were implanted with a CE-P bioprosthesis at Guangdong General Hospital between 2001 and 2007. Kaplan-Meier survival analysis and multivariate Cox proportional hazards regression were performed. Results: The mean age of the patients (N = 225) was only 61.2 ± 11.5 years at valve replacement. More than half of the patients (55.1%) had rheumatic heart disease. The survival rates were 86.46, 81.58, and 74.42% at 5 years, 64.39, 66.19, and 55.85% at 10 years, and 48.37, 57.33, and 46.54% at 15 years for the groups with mitral valve replacement (MVR), aortic valve replacement (AVR), and double valve replacement (DVR), respectively. The median time to freedom from SVD was 12.5, 13.2, and 11.2 years, respectively, for patients with MVR, AVR, and DVR. A higher age at valve replacement was a significant risk factor for SVD in all patients (p < 0.01). Conclusions: Good long-term clinical results of CE-P valves have been demonstrated in Chinese patients >60 years.

Real Structural Valve Deterioration of the Mitroflow Aortic Prosthesis: Competing Risk Analysis

Introduction and objectivesThe Mitroflow aortic prosthesis is a bovine pericardial bioprosthesis specially designed to increase the valve area in relation to its size. There is controversy regarding the pattern of structural valve deterioration (SVD). Our aim was to determine the cumulative incidence of SVD, risk factors influencing its occurrence, and its impact on mortality. MethodsA total of 1028 patients were clinically and echocardiographically followed up. Because the study population was elderly and had heart disease, we used a competing risk analysis. ResultsThe percentage of patients with SVD at 5 years was 4.22% (95%CI, 2.96-5.81) and was 15.77% at 8 years (95%CI, 12.46-19.43). The incidence was higher for small valves (19mm and 21mm) reaching 6.43% at 5 years (95%CI, 4.48-8.84) and 20.06% at 8 years (95%CI, 15.53-25.01). Severe patient-prosthesis mismatch (PPM) influenced the incidence of SVD (sHR, 3.53; 95%CI, 2.20-5.66; P < .001) but moderate PPM had no impact. The most powerful predictor of mortality was the presence of SVD (HR, 4.59; 95%CI, 2.91-7.22; P < .001). ConclusionsThis study used a definition based on the increase in the transprosthetic gradient and found a higher incidence of SVD of the Mitroflow prosthesis than that reported by other series, especially for sizes 19mm and 21mm and in patients with severe PPM. The incidence of SVD increased exponentially from the fifth year after implantation and its occurrence led to a 4.5-fold increase in the risk of death.

Acute Structural Failure of the Trifecta Aortic Valve Bioprosthesis

Advancements in bioprosthetic valve technology have greatly enhanced the haemodynamic performance and long-term durability of tissue valves. These features, along with the key advantage of avoiding lifelong anticoagulation, have made bioprosthetic valves increasingly attractive for clinicians and patients alike. The St Jude Trifecta valve is a novel, bovine pericardial bioprosthesis with promising early data for performance and safety. However, no prosthetic valve is perfect and prosthesis failure can occur with even the most reliable and well-designed devices. We report a case of early and acute structural deterioration (stent-post leaflet rupture) of the Trifecta valve, explanted after 33 months, in a 76-year-old male.

La degeneración real de la prótesis aórtica Mitroflow: análisis con riesgos competitivos

Introduction and objectivesThe Mitroflow aortic prosthesis is a bovine pericardial bioprosthesis specially designed to increase the valve area in relation to its size. There is controversy regarding the pattern of structural valve deterioration (SVD). Our aim was to determine the cumulative incidence of SVD, risk factors influencing its occurrence, and its impact on mortality. MethodsA total of 1028 patients were clinically and echocardiographically followed up. Because the study population was elderly and had heart disease, we used a competing risk analysis. ResultsThe percentage of patients with SVD at 5 years was 4.22% (95%CI, 2.96-5.81) and was 15.77% at 8 years (95%CI, 12.46-19.43). The incidence was higher for small valves (19mm and 21mm) reaching 6.43% at 5 years (95%CI, 4.48-8.84) and 20.06% at 8 years (95%CI, 15.53-25.01). Severe patient-prosthesis mismatch (PPM) influenced the incidence of SVD (sHR, 3.53; 95%CI, 2.20-5.66; P < .001) but moderate PPM had no impact. The most powerful predictor of mortality was the presence of SVD (HR, 4.59; 95%CI, 2.91-7.22; P < .001). ConclusionsThis study used a definition based on the increase in the transprosthetic gradient and found a higher incidence of SVD of the Mitroflow prosthesis than that reported by other series, especially for sizes 19mm and 21mm and in patients with severe PPM. The incidence of SVD increased exponentially from the fifth year after implantation and its occurrence led to a 4.5-fold increase in the risk of death.Full English text available from:www.revespcardiol.org/en

Midterm Durability and Hemodynamic Performance of a Third-Generation Bovine Pericardial Prosthetic Aortic Valve: The Leipzig Experience

The Trifecta valve (St. Jude Medical, St. Paul, MN) is a stented bovine pericardial bioprosthesis for aortic valve replacement (AVR). Implantation experience and midterm follow-up of this valve have not yet been reported from a large single-center cohort. We retrospectively analyzed data from 918 patients (73.2 ± 6.5 years; logistic European System for Cardiac Operative Risk Evaluation [EuroSCORE], 13.2 ± 14.3) who underwent AVR. Analyses addressed implantation safety, short- and long-term survival, and hemodynamic valve performance. Concomitant procedures were performed in 54.9% of the patients. Low cardiac output syndrome, postoperative bleeding requiring transfusion or reoperation, and acute renal failure requiring temporary hemodialysis occurred at rates of 4.3%, 7.0%, and 11.7%, respectively. At discharge, 44 patients (4.8%) were identified with moderate prosthesis-patient mismatch (PPM) and none was identified with severe PPM. Mean follow-up was 2.7 ± 1.6 years (maximum, 7.4 years). Survival at 30days was 88.7% and 92.0% for all patients and patients with isolated AVR, respectively; 5-year overall survival for these groups was 73.4% and 82.2%, respectively. Myocardial infarction (odds ratio [OR], 78; 95% confidence interval [CI], 20.8-294) and inotropic medication (OR, 6.8; 95% CI, 3.2-14.5) were the strongest independent predictors for long-term mortality. Five-year freedom from structural valve deterioration (SVD) was 97.9% ± 1.5%. Left ventricular ejection fraction (LVEF) after implantation was similar to baseline and was stable over time (range, 58.9%-62.3%). The mean gradient improved substantially (39.3 mm Hg at baseline versus 9.4 mm Hg at 6 months). This large single-center cohort shows the easy and safe implantation, adequate hemodynamic performance, and satisfactory durability of the Trifecta valve at midterm follow-up.

Transcatheter Aortic and Mitral Valve Replacement and Closure of Mitral Ring Perivalvular Leaks.

A 55-year-old man with a history of aortic valve (AV) replacement (27-mm Carpentier-Edwards Magna Bovine pericardial bioprosthesis), mitral valve (MV) repair (32-mm PhysioRing and edge-to-edge repair), and coronary artery bypass grafting 8 years before, presented with signs of congestive heart

The angiotensin II type 1 receptor blocker losartan attenuates bioprosthetic valve leaflet calcification in a rabbit intravascular implant model.

There is evidence that angiotensin II type I receptor blocker (ARB) could reduce structural valve deterioration. However, the anticalcification effect on the bioprosthetic heart valve (BHV) has not been investigated. Thus, we investigated the effects of losartan (an ARB) on calcification of implanted bovine pericardial tissue in a rabbit intravascular implant model. A total of 16 male New Zealand White rabbits (20 weeks old, 2.98-3.34 kg) were used in this study. Commercially available BHV leaflet of bovine pericardium was trimmed to the shape of a 3-mm triangle and implanted to both external jugular veins of the rabbit. The ARB group (n = 8) was given 25 mg/kg of powdered losartan daily until 6 weeks after surgery by direct administration in the buccal pouch of the animals. The control group (n = 8) was given 5 ml of normal saline by the same method. After 6 weeks, quantitative calcium determination, histological evaluation and western blot analysis of interleukin-6 (IL-6), osteopontin and bone morphogenetic protein 2 (BMP-2) were performed to investigate the mechanisms of the anticalcification effect of losartan. No deaths or complications such as infection or haematoma were recorded during the experiment. All animals were euthanized on the planned date. The calcium measurement level in the ARB group (2.28 ± 0.65 mg/g) was significantly lower than that in the control group (3.68 ± 1.00 mg/g) (P = 0.0092). Immunohistochemistry analyses revealed that BMP-2-positive reactions were significantly attenuated in the ARB group. Western blot analysis showed that losartan suppressed the expression of IL-6, osteopontin and BMP-2. Our results indicate that losartan significantly attenuates postimplant degenerative calcification of a bovine pericardial bioprosthesis in a rabbit intravascular implant model. Further studies are required to assess the effects of ARBs on BHV tissue in orthotopic implantations using a large animal model.