Dataset Information

One-year outcome with a bovine pericardial valve.

ABSTRACT:

Objectives

To evaluate the safety and effectiveness of a novel surgical bovine pericardial valve for aortic and mitral valve replacements.

Methods

Between 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.

Results

The 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.

Conclusions

The 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.

SUBMITTER: Chen J

PROVIDER: S-EPMC9390642 | biostudies-literature | 2020 Jun

REPOSITORIES: biostudies-literature

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Publications

One-year outcome with a bovine pericardial valve.

Chen Jinmiao J He Chen C Lv Minzhi M Guo Yingqiang Y Tao Liang L Hong Tao T Wang Chunsheng C

JTCVS open 20200421

<h4>Objectives</h4>To evaluate the safety and effectiveness of a novel surgical bovine pericardial valve for aortic and mitral valve replacements.<h4>Methods</h4>Between 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. ...[more]

PMID: 36003682

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Project description: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.

Project description:Objectives The 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. Methods From 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. Results Overall 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. Conclusions With 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

Project description:ImportanceBioprosthetic mitral valves are implanted with increasing frequency but inevitably degenerate, leading to heart failure. Reoperation is associated with high morbidity and mortality. Transcatheter mitral valve-in-valve (MViV) using balloon-expandable transcatheter valves has emerged as an alternative for high-surgical risk patients.ObjectiveTo assess contemporary outcomes of SAPIEN 3 (Edwards Lifesciences) MViV replacement.Design, setting, and participantsIn this registry-based prospective cohort study of SAPIEN 3 MViV, patients entered in the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry from June 2015 to July 2019 were analyzed. US Centers for Medicare and Medicaid linkage ensured comprehensive collection of death and stroke data.ExposuresMitral valve-in-valve for degenerated bioprosthetic mitral valves.Main outcomes and measuresThe primary efficacy end point was 1-year mortality. The primary safety end point was procedural technical success as defined by the Mitral Valve Academic Research Consortium criteria. Secondary end points included 30-day mortality, New York Heart Association-defined heart failure, and mitral valve performance.ResultsA total of 1529 patients (mean [SD] age, 73.3 [11.84] years; 904 women [59.1%]) underwent transseptal or transapical MViV implant at 295 hospitals between June 2015 and July 2019. The mean (SD) Society of Thoracic Surgeons predicted risk of mortality was 11.1% (8.7%). Procedural technical success was achieved for 1480 of 1529 patients (96.8%). All-cause mortality was 5.4% at 30 days and 16.7% at 1 year. Transseptal access was associated with lower 1-year all-cause mortality than transapical access (15.8% vs 21.7%; P = .03). Transcatheter MViV led to early, sustained, and clinically meaningful improvements in heart failure (class III/IV New York Heart Association heart failure of 87.1% at baseline vs 9.7% at 1 year). The mean (SD) mitral valve gradient at 1 year was 7 (2.89) mm Hg.Conclusions and relevanceTranscatheter MViV using the SAPIEN 3 transcatheter heart valve is associated with high technical success, low 30-day and 1-year mortality, significant improvement of heart failure symptoms, and sustained valve performance. Transseptal MViV should be considered an option for most patients with failed surgical bioprosthetic valves and favorable anatomy.

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.

Dataset Information

One-year outcome with a bovine pericardial valve.

Objectives

Methods

Results

Conclusions

Publications

One-year outcome with a bovine pericardial valve.

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