Comparison on Clinical Outcomes Between China-made CL-V Bileaflet Prosthesis and St. Jude Bileaflet Prosthesis_Chinese Journal of Clinical Thoracic and Cardiovascular Surgery

Authors：

QI Liang , SONG Bing , LIU Ruisheng , TANG Hanbo , ZHAO Honglin , XING Wang , GAO Baishun.

Department of Cardiovascular Surgery， First Hospital of Lanzhou University， Lanzhou 730000， P. R. China;

Corresponding author：

Keywords：

Valvular heart disease; 　CL-V bileaflet prosthesis; 　St. Jude bileaflet prosthesis

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Abstract：　Objective　To evaluate early clinical outcomes and short-term follow-up results of CL-V bileaflet prosthesis. Methods From April 2004 to May 2010， 38 patients with valvular heart diseases underwent mechanical heart valve replacement. Eighteen patients received CL-V bileaflet valve replacement （CL group） including 8 males and 10　females with their mean age of （47.4±6.2）years and mean body weight of （64.7±11.9） kg. Preoperatively，15 patients were in New York Heart Association （NYHA） classⅢ， and 2 patients were in NYHA classⅣ. Mitral valve replacement （MVR） was performed in 16 patients， mitral and aortic valve replacement（DVR） in 2 patients. A total of 20 CL-V bileaflet prostheses were implanted. Twenty patients received St. Jude bileaflet valve replacement （SJM group）including 9 males and 11 females with their mean age of （49.7±7.6） years and mean body weight of （66.1±11.1） kg. Preoperatively，　15 patients were in NYHA classⅢ， and 3 patients were in NYHA classⅣ. MVR was performed in 17 patients，aortic valve replacement （AVR） in 1 patient， and DVR in 2 patients. A total of 22 St. Jude bileaflet prostheses were implanted. Clinical outcomes， hear function， hemodynamics and blood compatibility were measured on the 7th postoperative day and 6 months during follow-up and compared between the two groups. Results There was no early mortality （＜30 d） or　postoperative complication in either group. Follow-up rate was 100% and the mean follow-up duration was 19.8 （6-61）
months. At 6 months after surgery， those patients who were preoperatively in NYHA classⅢ orⅣall improved to classⅠ orⅡ. In CL group， cardiothoracic ratio was 0.51±0.05， left atrium diameter （44.5±7.8） mm， left ventricular end diastolic diameter （LVEDD，46.6±4.1） mm， LVEF 65.3%±7.7%，and LVFS 35.0%±7.1%. In SJM group， cardiothoracic ratio was 0.51±0.06， left atrium diameter （45.8±9.6） mm， LVEDD （46.2±9.8） mm， LVEF 64.1%±9.0%，and LVFS 34.9%±4.7%， which were not statistically different from those parameters of CL group respectively （P＞0.05）. At 6 months after surgery， transthoracic echocardiography was used to compare hemodynamics of bileaflet prostheses with same size 27 mm in the two groups. Prosthetic transvalvular gradient was （5.1±0.9）mm Hg in CL group and （5.8±0.8） mm Hg in SJM group， and effective orifice area was （2.3±0.3）cm2 in CL group and（2.5±0.2）cm2 in SJM group，which were not statistically significant between the two groups （P＞0.05） respectively. In both groups， the level of
hemoglobin， lactate dehydrogenase and platelet at 6 months postoperatively were all within normal range and not statistically from those respective　preoperative parameters（P＞0.05）. Hemolytic reaction and hemolytic anemia were not found. During early and short-term follow-up， there was no　thromboembolic complications or anticoagulation-related severe bleeding events in the two groups with same anticoagulation intensity target （target INR value 1.5 to 2.5）. Conclusion　Early clinical outcomes and short-term follow-up results of CL-V bileaflet prostheses are similar to those of St. Jude bileaflet prostheses. Postoperative patients have good clinical outcomes， hemodynamics and blood compatibility. Patients’ heart function significantly improve during short-term follow-up without valve-related complication. Mid-term and Long-term follow-up are further needed to demonstrate its good performance.

Citation： QI Liang,SONG Bing,LIU Ruisheng,TANG Hanbo,ZHAO Honglin,XING Wang,GAO Baishun.. Comparison on Clinical Outcomes Between China-made CL-V Bileaflet Prosthesis and St. Jude Bileaflet Prosthesis. Chinese Journal of Clinical Thoracic and Cardiovascular Surgery, 2012, 19(4): 376-380. doi: Copy

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9.	陈如坤，董爱强，徐世伟. 国产久灵全热解碳双叶型人造心脏瓣膜的临床研究. 中华医学杂志， 2000， 80 （9）：687-688.
10.	仲京，易定华，蒋树林，等. 国产GK型双叶式人工心脏瓣膜的临床应用. 中国胸心血管外科临床杂志， 2005，12 （5）：309-311.
11.	Bonow RO， Carabello BA， Chatterjee K， et al. 2008 focused update incorporated into the ACC/AHA 2006 guidelines for the management of patients with valvular heart disease： a report of the American　College of Cardiology/American Heart Association Task Force on Practice Guidelines （Writing　Committee to revise the 1998 guidelines for the management of patients with valvular heart disease）.　Endorsed by the Society of Cardiovascular　Anesthesiologists，Society for Cardiovascular Angiography and Interventions， and　Society of Thoracic Surgeons. J Am Coll Cardiol， 2008， 52 （13）：e1-e142.
12.	Rosenhek R， Binder T， Maurer G， et al. Normal values for Doppler echocardiographic assessment of heart valve prostheses. J Am Soc Echocardiogr， 2003， 16 （11）：1116-1127.
13.	Remadi JP， Bizouarn P， Baron O， et al. Mitral valve replacement with the St. Jude Medical prosthesis： a 15-year follow-up. Ann Thorac Surg， 1998， 66 （3）：762-767.
14.	Josa M， Castellá M， Paré C， et al. Hemolysis in mechanical bileaflet prostheses： experience with the Bicarbon valve. Ann Thorac Surg， 2006， 81 （4）：1291-1296.
15.	Mecozzi G， Milano AD， De Carlo M， et al. Intravascular hemolysis in patients with new-generation prosthetic heart valves： a prospective study. J Thorac Cardiovasc Surg， 2002， 123 （3）：550-556.
16.	Misawa Y， Saito T， Konishi H， et al. Clinical experience with the Bicarbon heart valve prosthesis. J Cardiothorac Surg， 2007， 13 （2）：8-9.
17.	Le Tourneau T， Lim V， Inamo J， et al. Achieved anticoagulation vs prosthesis selection for mitral mechanical valve replacement： a population-based outcome study. Chest， 2009， 136 （6）：1503-1513.

1. mechanical heart valves. J Heart Valve Dis， 2007， 16 （2）：151-158.
2. 　李志刚，张宝仁，梅举，等. 国产C-L双叶机械瓣动物实验结果. 第二军医大学学报， 2007， 28 （9）：1019-1021.
3. 　杨子彬. 人工心脏瓣膜研究的进展. 现代临床医学生物工程学杂志， 1995， 1 （1）：7-9.
4. 　Bernet FH， Baykut D， Grize L， et al. Single-center outcome analysis of 1， 161 patients with St. Jude medical and ATS open pivot.
5. 　Cianciulli TF， Lax JA， Beck MA， et al. Valve replacement with bileaflet HP-Biplus mechanical prostheses versus standard prostheses： long-term results. J Heart Valve Dis， 2008， 17 （2）：206-215.
6. 　Tossios P， Reber D， Oustria M， et al. Single-center experience with the On-X prosthetic heart valve between 1996 and 2005. J Heart Valve Dis， 2007， 16 （5）：551-557.
7. 　刘维永. 心脏瓣膜外科的现状与发展趋势. 中国胸心血管外科临床杂志， 1999， 6 （2）：65.
8. 　田子朴，陈匡民. 双叶机械瓣的研制和临床应用初步报告. 中华胸心血管外科杂志， 1992， 8 （1）：1.
9. 　陈如坤，董爱强，徐世伟. 国产久灵全热解碳双叶型人造心脏瓣膜的临床研究. 中华医学杂志， 2000， 80 （9）：687-688.
10. 　仲京，易定华，蒋树林，等. 国产GK型双叶式人工心脏瓣膜的临床应用. 中国胸心血管外科临床杂志， 2005，12 （5）：309-311.
11. 　Bonow RO， Carabello BA， Chatterjee K， et al. 2008 focused update incorporated into the ACC/AHA 2006 guidelines for the management of patients with valvular heart disease： a report of the American　College of Cardiology/American Heart Association Task Force on Practice Guidelines （Writing　Committee to revise the 1998 guidelines for the management of patients with valvular heart disease）.　Endorsed by the Society of Cardiovascular　Anesthesiologists，Society for Cardiovascular Angiography and Interventions， and　Society of Thoracic Surgeons. J Am Coll Cardiol， 2008， 52 （13）：e1-e142.
12. 　Rosenhek R， Binder T， Maurer G， et al. Normal values for Doppler echocardiographic assessment of heart valve prostheses. J Am Soc Echocardiogr， 2003， 16 （11）：1116-1127.
13. 　Remadi JP， Bizouarn P， Baron O， et al. Mitral valve replacement with the St. Jude Medical prosthesis： a 15-year follow-up. Ann Thorac Surg， 1998， 66 （3）：762-767.
14. 　Josa M， Castellá M， Paré C， et al. Hemolysis in mechanical bileaflet prostheses： experience with the Bicarbon valve. Ann Thorac Surg， 2006， 81 （4）：1291-1296.
15. 　Mecozzi G， Milano AD， De Carlo M， et al. Intravascular hemolysis in patients with new-generation prosthetic heart valves： a prospective study. J Thorac Cardiovasc Surg， 2002， 123 （3）：550-556.
16. 　Misawa Y， Saito T， Konishi H， et al. Clinical experience with the Bicarbon heart valve prosthesis. J Cardiothorac Surg， 2007， 13 （2）：8-9.
17. 　Le Tourneau T， Lim V， Inamo J， et al. Achieved anticoagulation vs prosthesis selection for mitral mechanical valve replacement： a population-based outcome study. Chest， 2009， 136 （6）：1503-1513.

Chinese Journal of Clinical Thoracic and Cardiovascular Surgery

Comparison on Clinical Outcomes Between China-made CL-V Bileaflet Prosthesis and St. Jude Bileaflet Prosthesis

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