PMID- 34277057
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220424
IS  - 2072-1439 (Print)
IS  - 2077-6624 (Electronic)
IS  - 2072-1439 (Linking)
VI  - 13
IP  - 6
DP  - 2021 Jun
TI  - Medium long-term follow-up outcomes of BalMedic((R)) bovine pericardial 
      bioprosthetic valve in the mitral position.
PG  - 3652-3659
LID - 10.21037/jtd-21-734 [doi]
AB  - BACKGROUND: In 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. METHODS: A 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((R)) 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. RESULTS: The 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. 
      CONCLUSIONS: In relation to the medium long-term clinical follow-up results, the 
      durability performance of the BalMedic((R)) 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.
CI  - 2021 Journal of Thoracic Disease. All rights reserved.
FAU - Yang, Sumin
AU  - Yang S
AD  - Department of Cardiac Surgery, The Affiliated Hospital of Qingdao University, 
      Qingdao, China.
FAU - Hu, Haoyu
AU  - Hu H
AD  - Department of Cardiac Surgery, The Affiliated Hospital of Qingdao University, 
      Qingdao, China.
FAU - Lin, Minghao
AU  - Lin M
AD  - Department of Cardiac Surgery, The First People's Hospital of Yulin, Yulin, 
      China.
FAU - Gan, Naiyan
AU  - Gan N
AD  - Department of Cardiac Surgery, The First People's Hospital of Yulin, Yulin, 
      China.
LA  - eng
PT  - Journal Article
PL  - China
TA  - J Thorac Dis
JT  - Journal of thoracic disease
JID - 101533916
PMC - PMC8264715
OTO - NOTNLM
OT  - BalMedic(R)
OT  - bovine pericardial valves
OT  - medium long-term follow-up
OT  - mitral valves
COIS- Conflicts of Interest: All authors have completed the ICMJE uniform disclosure 
      form (available at http://dx.doi.org/10.21037/jtd-21-734). The authors have no 
      conflicts of interest to declare.
EDAT- 2021/07/20 06:00
MHDA- 2021/07/20 06:01
PMCR- 2021/06/01
CRDT- 2021/07/19 05:56
PHST- 2021/02/26 00:00 [received]
PHST- 2021/06/08 00:00 [accepted]
PHST- 2021/07/19 05:56 [entrez]
PHST- 2021/07/20 06:00 [pubmed]
PHST- 2021/07/20 06:01 [medline]
PHST- 2021/06/01 00:00 [pmc-release]
AID - jtd-13-06-3652 [pii]
AID - 10.21037/jtd-21-734 [doi]
PST - ppublish
SO  - J Thorac Dis. 2021 Jun;13(6):3652-3659. doi: 10.21037/jtd-21-734.