Use of the BalMedic bovine pericardial bioprosthetic valve in China: a new light on the horizon?
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ABSTRACT:
SUBMITTER: Luehr M
PROVIDER: S-EPMC8039655 | biostudies-literature | 2021 Mar
REPOSITORIES: biostudies-literature
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Use of the BalMedic bovine pericardial bioprosthetic valve in China: a new light on the horizon?
Luehr Maximilian M Wahlers Thorsten T
Annals of translational medicine 20210301 6
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Project description:BackgroundThis study aimed to compare long-term outcomes, including durability, after bovine pericardial valve replacement with those after porcine mitral valve replacement (MVR).MethodsWe enrolled 309 patients who underwent MV replacement (mean age: 65.8±11.5 years; 68.9% females) with Carpentier-Edwards PERIMOUNT bovine pericardial valves (bovine MVR group, n=241) or Hancock II porcine bioprosthesis (porcine MVR group, n=68). The mean clinical and echocardiographic follow-up durations were 81.4±60.0 and 57.8±53.3 months, respectively. Structural valve deterioration (SVD) was defined as prosthetic mitral valve (MV) regurgitation or stenosis of greater than moderate degree combined with a motion limitation, tear, or perforation of prosthetic valve leaflet on follow-up echocardiography. Propensity score (PS)-adjusted multivariable analyses were performed.ResultsThirty-day mortality rate was 6.4% (20/309 patients). SVD occurred in 50 patients (33 and 17 patients in the bovine and porcine MV replacement groups, respectively). Cumulative incidences of SVD at 5, 10, and 15 years were 3.2%, 15.9%, and 32.4%, respectively, in the bovine MVR group and 1.9%, 15.3%, and 41.7%, respectively, in the porcine MVR group. Cumulative incidences of SVD in the two groups were not different in competing risk analysis (P=0.23). Other clinical outcomes including overall survival and cumulative incidences of cardiac death and MV-related events were not statistically significantly different between the groups in PS-adjusted multivariable analyses.ConclusionsLong-term clinical outcomes including SVD were not different between the bovine and porcine bioprosthesis MVR groups during average 7 years of clinical follow-up after MVR.
| S-EPMC8339742 | biostudies-literature
Project description:BackgroundIn China, where Rheumatic heart disease is still prevalent, two thirds of valve replacements are in mitral position. Before a valve replacement operation is conducted, most patients have reached Class III/IV heart function under the New York Heart Association (NYHA) classification system. As the background to this disease is quite different to that of degenerated cases, which are more prevalent in Western countries, the development of an artificial heart valve that is suitable for local patients is very significant for China. In this medium long-term clinical follow-up study, a data analysis was conducted of domestic heart valve production for mitral replacement.MethodsA total of 288 patients who underwent mitral valve replacements from 2005 to 2015 at 2 cardiac surgery centres (i.e., The Affiliated Hospital of Qingdao University, and The First People's Hospital of Yulin) were evaluated. All implanted bioprostheses were BalMedic® bovine pericardial bioprosthetic valves, which had been granted marketing approval by the China Food and Drug Administration (CFDA) in 2003. Double valve cases that involved both aortic and mitral replacements were not included in the study. On average, patients were aged 54.5±10.8 (range, 11 to 77 years) before the procedure. The mean follow-up period was 7.2±2.6 years. The study examined the overall survival (OS) curve, and different age group results. To gain further insights into the functions of the valves, the OS curve and the age group results for the reoperation-free and structural valve deterioration (SVD)-free rates are also presented.ResultsThe 10-year OS rate was 65.6%, the 10-year reoperation-free rate was 76.3%, and the 10-year SVD-free rate was 58.0%. In relation to the age group results, younger patients had higher survival rates, while older patients had higher reoperation-free rates and SVD-free rates.ConclusionsIn relation to the medium long-term clinical follow-up results, the durability performance of the BalMedic® bovine pericardial valve in the mitral position was satisfactory, especially among patients whose heart function was worse than that of Western sufferers. Survival rate, reoperation-free rate and SVD-free rate were used for the comprehensive analysis.
| S-EPMC8264715 | biostudies-literature
Project description:ObjectivesTo evaluate the safety and effectiveness of a novel surgical bovine pericardial valve for aortic and mitral valve replacements.MethodsBetween March 2016 and October 2017, 197 patients (mean age, 66.9 ± 4.9 years; 40.6% were women) underwent aortic valve replacement and mitral valve replacement and were implanted with the Cingular bovine pericardial valve (Shanghai Cingular Biotech Corporation, Shanghai, China) in a prospective, multicenter, single-arm trial in China. A total of 161 aortic and 49 mitral prostheses were implanted. Patients were followed up to 1 year. The primary end point was the 1-year overall rate of valve-related complications, including thromboembolic event, valve thrombosis, major hemorrhage event, major perivalvular leak, and prosthetic valve endocarditis.ResultsThe 1-year overall rate of valve-related complications was 0.5% (95% confidence interval, 0.1%-3.7%). The 1-year survival was 96.4%. The mean gradient and effective orifice area for aortic prostheses at 1 year postoperatively were 12.8 ± 4.4 mm Hg and 1.9 ± 0.3 cm2, respectively. Particularly, the mean gradients and effective orifice area for 19 mm and 21 mm sizes of aortic prostheses at 1 year were 17.0 ± 3.8 mm Hg and 1.6 ± 0.2 cm2, 13.1 ± 4.0 mm Hg and 1.8 ± 0.1 cm2, respectively. Patient-prosthesis mismatch occurred in only 1.3% patients for aortic valve implantation at 1 month. No structural valve deterioration and no endocarditis occurred.ConclusionsThe Cingular bovine pericardial valve was safe and effective for surgical aortic and mitral valve replacement. The 1-year rate of valve-related complications was very low. Early hemodynamic performance was excellent even for the small aortic root.
| S-EPMC9390642 | biostudies-literature
Project description: Not available
| S-EPMC8940997 | biostudies-literature
Project description:PurposeThis case-control retrospective discovery study is to identify antigenic bovine pericardium (BP) proteins that stimulate graft-specific humoral immune response in patients implanted with glutaraldehyde fixed bovine pericardial (GFBP) heart valves.Experimental designBanked serum is collected from age- and sex-matched patients who received either a GFBP or mechanical heart valve replacement. Serum IgG is isolated and used to generate poly-polyclonal antibody affinity chromatography columns from each patient. Native and deglycosylated BP protein extracts are separately added to individual patient affinity chromatography columns, with unbound proteins washed through the column. Proteins captured in the affinity chromatography columns are submitted for proteomic identification. Differences between GFBP and mechanical heart valve replacement recipients are analyzed with Gaussian linearized modeling.ResultsCarbohydrate antigens overwhelm protein capture in the column, requiring BP protein deglycosylation prior to affinity chromatography. Nineteen BP protein antigens, which stimulated graft-specific IgG production, are identified in patients who received GFBP valve replacements. Identified antigens are significantly over-represented for calcium-binding proteins.Conclusions and clinical relevancePatients implanted with GFBP valves develop a graft-specific humoral immune response toward BP protein antigens, with 19 specific antigens identified in this work. The molecular functions of over-represented antigens, specifically calcium-binding proteins, may aid in understanding the underlying factors that contribute to structural valve deterioration.
| S-EPMC6565515 | biostudies-literature
Project description:Objectives: To evaluate the 2-year clinical safety and hemodynamic outcomes of the Cingular bovine pericardial bioprosthesis. Methods: A prospective, multicenter, single-arm trial was conducted in patients who required aortic or mitral valve replacement. From March 2016 to October 2017, 197 patients were implanted with the Cingular bovine pericardial valve at five sites in China. The clinical outcomes and hemodynamic performance were assessed through a 2-year follow-up. Clinical safety events were reviewed by an independent clinical events committee, and echocardiographic data were assessed by an independent core laboratory. Results: The mean age was 66.9 ± 4.9 years. The 2-year survival rate was 96.4%. A complete 2-year clinical follow-up was achieved in 189 of 190 survivors. No case of structural valve deterioration, major perivalvular leak, prosthetic valve endocarditis, or valve-related reoperation was seen. For the aortic valve, the mean pressure gradient observed was 12.5 ± 4.0 mm Hg, and the effective orifice area (EOA) was 2.0 ± 0.3 cm2. For the smaller size aortic valves, 19 mm and 21 mm, respective mean EOA values of 1.7 ± 0.2 cm2 and 1.8 ± 0.2 cm2 were found. The values for mean pressure gradient and mean EOA for mitral bioprostheses were 4.0 ± 1.4 mm Hg and 2.2 ± 0.3 cm2, respectively. There was no significant change between 1-year and 2-year hemodynamic performance. Conclusions: The Cingular bovine pericardial valve showed favorable clinical safety and hemodynamic outcomes over a 2-year follow-up. Further follow-up is required to validate the long-term durability.
| S-EPMC8711235 | biostudies-literature
Project description:ObjectivesThe short-term performance of the Cingular bovine pericardial aortic valve was proven. This study evaluated its 5-year safety and haemodynamic outcomes.MethodsIt 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.ResultsThe 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.ConclusionsThe 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.
| S-EPMC10781661 | biostudies-literature
Project description: Not available
| S-EPMC8167470 | biostudies-literature
Project description:Objective: Sevelamer hydrochloride is a phosphate binder used to treat hyperphosphatemia in chronic kidney disease (CKD) patients that can reduce valvular and vascular calcification. The aim of this study was to examine the effects of sevelamer treatment on calcification in bioprosthetic heart valves (BHVs). Methods: Wister rats were randomly divided into three groups according to sevelamer intake and implantation (sham-sham operation; implant-implantation and normal diet, implant+S implantation, and sevelamer diet). Two kinds of BHVs-bovine pericardium treated with glutaraldehyde (GLUT) or non-GLUT techniques-were implanted in rat dorsal subcutis at 4 weeks. After implantation, sevelamer was administered to the implant+S group. The animals were executed at days 0 (immediately after implantation), 7, 14, 28, and 56. Calcium levels were determined by atomic absorption spectroscopy and von Kossa staining. Serum biochemistry analysis, Western blotting, real-time quantitative polymerase chain reaction, alkaline phosphatase activity measurement, histopathologic analysis, immunohistochemistry, and enzyme-linked immunosorbent assay were conducted to identify the anti-calcification mechanism of sevelamer. Results: Non-GLUT crosslinking attenuates BHV calcification. Serum phosphate and calcium remained unreactive to sevelamer after a 14-day treatment. However, the mean calcium level in the implant+S group was significantly decreased after 56 days. In addition, the PTH level, inflammatory cell infiltration, system and local inflammation, and expression of Bmp2, Runx2, Alp, IL-1β, IL-6, and TNF-α were significantly reduced in the implant+S group. Conclusion: Sevelamer treatment significantly attenuated the calcification of BHVs and had anti-inflammation effects that were independent from serum calcium and phosphate regulation. Thus, sevelamer treatment might be helpful to improve the longevity of BHVs.
| S-EPMC8514018 | biostudies-literature
Project description:BackgroundHere, we outline the case of a US Veteran's Health Administration (VA) patient with a history of recent bioprosthetic aortic valve replacement (AVR) and recent intravenous drug use (IVDU) who was found to have three-valve infective endocarditis (IE) resulting in septic shock. We highlight this case because it represents an uncommon case of three-valve IE in the setting of recent bioprosthetic valve replacement and IVDU, and it raises the need for continued awareness of mental health and drug rehabilitation in the US military veteran population.Case summaryA 62-year-old gentleman with recent bioprosthetic AVR presented with dyspnoea and lower extremity oedema and was found to have a heart failure exacerbation. He developed sepsis and was found to have three-valve endocarditis, as well as aortic root abscess and pacemaker lead infection. He was treated with broad-spectrum antibiotics and evaluated for surgical intervention. After discussion with the surgical team, the patient decided not to pursue surgery due to prohibitively high perioperative mortality risk. The patient was transferred to hospice and expired within 2 weeks.DiscussionThree-valve IE is sparingly documented in published literature and can be difficult to treat. Providers must be cognizant of prosthetic valve endocarditis as an uncommon but known complication of valve replacement surgery. Intravenous drug use is a common risk factor for endocarditis and is prevalent in the US military veteran population. Prosthetic valve endocarditis should be treated with broad-spectrum antibiotics, and in general, if it leads to new significant valvular abnormalities, the valve should be replaced.
| S-EPMC7042142 | biostudies-literature