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1、病人选择和操作方法 : 机械瓣 vs 生物瓣主动脉瓣替换 西方观点,Joseph F. Sabik, M.D. The Cleveland Clinic,推荐,“新”的好的瓣膜与“旧”的好的瓣膜结果相似。生物瓣在老年病人中结构性瓣膜毁损率低。在 60 to 65 病人是首选,推荐,新的生物瓣和机械瓣有更好的血流动力学。耐久性和病人死亡率比旧的生物瓣更好单纯根据病人年龄来决定采用什么瓣膜可能不能为个体病人作出正确的决策。,or,?,前瞻性随机研究,Edinburgh Heart Valve Trial 533 patients; 1975 to 1979 Bjork-Shiley vs. por
2、cine (Hancock, Carpentier-Edwards) Bloomfield, et al. New Engl J Med 1991;324:573-9. Oxenham, et al. Heart 2003;89:715-21. Veterans Affairs Cooperative Study 575 patients; 1977 to 1982 Bjork-Shiley vs. Hancock Hammeremister, et al. New Engl J Med 1993;328:1289-96. Hammermeister, et al. J Am Coll Car
3、diol 2000;36:1152-8.,0,5,10,15,20,Years after randomization,100 80 60 40 20 0,Bjork-Shiley,%,Porcine,Source: H,生存率 Edinburgh Heart Valve Trial,P=0.39,100 80 60 40 20 0,0,2,4,6,8,10,12,14,16,Bioprosthesis,Mechanical Prosthesis,Years after valve replacement,Mortality %,Hammermeister et al., JACC:2000,
4、P=0.02,死亡率,VA Cooperative Study,100 80 60 40 20 0,0,2,4,6,8,10,12,14,16,Mechanical Prosthesis,Years after valve replacement,All Valve-related Complications %,Hammermeister et al., JACC:2000,P=0.26,Bioprosthesis,瓣膜相关性并发症,VA Cooperative Study,100 80 60 40 20 0,0,2,4,6,8,10,12,14,16,Mechanical Prosthes
5、is,Years after valve replacement,P=0.0001,Bioprosthesis,Bleeding %,出血,VA Cooperative Study,100 80 60 40 20 0,0,2,4,6,8,10,12,14,16,Mechanical Prosthesis,Years after valve replacement,Bleeding %,Hammermeister et al., JACC:2000,P=0.0001,Bioprosthesis,瓣膜功能障碍,VA Cooperative Study,100 80 60 40 20 0,0,2,4
6、,6,8,10,12,14,16,Mechanical Prosthesis,Years after valve replacement,All Reoperations %,Hammermeister et al., JACC:2000,P=0.004,Bioprosthesis,再次手术,VA Cooperative Study,生物瓣 vs. 机械瓣 AHA/ACC 标准,采用生物瓣的年龄标准是基于65岁以上病人结构性瓣膜毁损明显下降和出血风险明显升高决定的。,年龄 主要的瓣膜选择标准, 65 - 70 岁: 生物瓣 65 - 70 岁: 机械瓣,AHA/ACC 指南,避免 华法林风险
7、再次手术,个体病人 什么是华法林风险？ 什么是再次手术的风险？,机械瓣风险,年龄 vs INR 出血的时间,75th percentile,50th percentile,25th percentile,Wittkowsky, Pharmacotherapy. 2004,David et al. 1996.,CarboMedics,St. Jude,Medtronic-Hall,3.0,1.0,0.0,2.0,P = .8,FDA: OPC,Percent Per Year,机械瓣血栓形成,Free of Complications,Other Deaths,Bleeding,TE,Reop/
8、Endo,Valve Related Deaths,100 80 60 40 20 0,0,5,10,15,Yrs Postop,Zellner, Ann Thorac Surg: 1999,免予并发症率 St. Jude AVR,生物瓣风险,Survival,%,Years,96,76,52,26,竞争事件,%,Years,Event-free Survival,Death before Explant,Explant for SVD,结构毁损而取出,%,Years,45,55,65,75,Age,再次手术死亡率,20 15 10 5 0,% Mort.,Combined,Isolated,
9、4.1%,5.8%,1994,1996,1998,2000,2002,2004,瓣膜演变,生物瓣 改善血流动力学 抗钙化 耐久性延长 机械瓣 抗凝药物治疗,16 14 12 10 8 6,50,55,60,65,70,75,LE Bio,Age of Implantation,Years,Source: ,LE Mech,EFLE Mech,EFLE Bio,Event-Free Life Expectancy,Aortic Valve Replacement,Recommendations Valve Choice,Clinical situation Patient preference,
10、Clinical Recommendations Tissue Valve,Limited life expectancy Older Age CAD-severe LV dysfunction-severe Comorbidities-severe Increased bleeding risk,临床建议-机械瓣,华法林 60 岁,病人倾向性性 生活质量,机械瓣: 无结构毁损问题 再次手术少 抗凝 生物瓣: 结构毁损和再次手术 免予抗凝及抗凝相关出血。,Bioprostheses Mechanical Homograft,100 80 60 40 20,主动脉瓣膜 1995-2005,%,1
11、995,1997,1999,2005,2001,2003,100 80 60 40 20 0,80,2005 单纯主动脉瓣年龄,Human Repair Mechanical Bioprostheses,Age,%,AVR 人群,年龄 1980-1995 62 years 1996 - 2005 73 years 70% 合并冠心病 15 % 病人 65 years,or,?,瓣膜相关问题 耐久性 需要抗凝 病人相关问题 预期寿命Life Expectancy 倾向性,Patient Selection and Practice Patterns : Mechanical vs Biopros
12、thetic Aortic Valves Perspective West,Joseph F. Sabik, M.D. The Cleveland Clinic,Recommendations,Outcomes with “new” good valves are similar to those with “older” good valves. Bioprostheses have a low rate of SVD in the older patient andare the PHV of choice for AVR in patients 60 to 65 years of age
13、.,Recommendations,Newer tissue and mechanical prostheses afford superior hemodynamics. Durability and patient mortality are superior with newer compared with older bioprostheses. Arbitrary cutoffs dictating valve choice based on age may not give appropriate weight to individual patient perspectives.
14、,or,?,Prospective Randomized Trials,Edinburgh Heart Valve Trial 533 patients; 1975 to 1979 Bjork-Shiley vs. porcine (Hancock, Carpentier-Edwards) Bloomfield, et al. New Engl J Med 1991;324:573-9. Oxenham, et al. Heart 2003;89:715-21. Veterans Affairs Cooperative Study 575 patients; 1977 to 1982 Bjor
15、k-Shiley vs. Hancock Hammeremister, et al. New Engl J Med 1993;328:1289-96. Hammermeister, et al. J Am Coll Cardiol 2000;36:1152-8.,0,5,10,15,20,Years after randomization,100 80 60 40 20 0,Bjork-Shiley,%,Porcine,Source: H,Survival Edinburgh Heart Valve Trial,P=0.39,100 80 60 40 20 0,0,2,4,6,8,10,12,
16、14,16,Bioprosthesis,Mechanical Prosthesis,Years after valve replacement,Mortality %,Hammermeister et al., JACC:2000,P=0.02,Mortality,VA Cooperative Study,100 80 60 40 20 0,0,2,4,6,8,10,12,14,16,Mechanical Prosthesis,Years after valve replacement,All Valve-related Complications %,Hammermeister et al.
17、, JACC:2000,P=0.26,Bioprosthesis,Valve-Related Complications,VA Cooperative Study,100 80 60 40 20 0,0,2,4,6,8,10,12,14,16,Mechanical Prosthesis,Years after valve replacement,P=0.0001,Bioprosthesis,Bleeding %,Bleeding,VA Cooperative Study,100 80 60 40 20 0,0,2,4,6,8,10,12,14,16,Mechanical Prosthesis,
18、Years after valve replacement,Bleeding %,Hammermeister et al., JACC:2000,P=0.0001,Bioprosthesis,Primary Valve Failure,VA Cooperative Study,100 80 60 40 20 0,0,2,4,6,8,10,12,14,16,Mechanical Prosthesis,Years after valve replacement,All Reoperations %,Hammermeister et al., JACC:2000,P=0.004,Bioprosthe
19、sis,Reoperation,VA Cooperative Study,Tissue vs. Mechanical AHA/ACC Criteria,The age at which patients may be considered for bioprosthetic valves is based on the major reduction in rate of structural valve deterioration after age 65 and the increased risk of bleeding in this age group.,Age Major Crit
20、eria for Valve Selection, 65 - 70 years: Tissue prosthesis 65 - 70 years: Mechanical prosthesis,Basis of AHA/ACC Guidelines,Avoid Risks of Warfarin Reoperation,For Individual Patient What is the risk of warfarin? What is the actual likelihood and risk of reoperation?,Mechanical Valve Risk,Age vs INR
21、 Time of Major Bleeding,75th percentile,50th percentile,25th percentile,Wittkowsky, Pharmacotherapy. 2004,David et al. 1996.,CarboMedics,St. Jude,Medtronic-Hall,3.0,1.0,0.0,2.0,P = .8,FDA: OPC,Percent Per Year,Mech Valve Thrombosis,Free of Complications,Other Deaths,Bleeding,TE,Reop/Endo,Valve Relat
22、ed Deaths,100 80 60 40 20 0,0,5,10,15,Yrs Postop,Zellner, Ann Thorac Surg: 1999,Freedom from Complications St. Jude AVR,Bioprosthetic Valve Risk,Survival,%,Years,96,76,52,26,Competing Events,%,Years,Event-free Survival,Death before Explant,Explant for SVD,Explant for SVD,%,Years,45,55,65,75,Age,Valv
23、e Reoperations Mortality,20 15 10 5 0,% Mort.,Combined,Isolated,4.1%,5.8%,1994,1996,1998,2000,2002,2004,Prosthesis Evolution,Bioprosthesis Improved hemodynamics Anti-calcification Enhanced durability Mechanical prostheses Management of anticoagulation,16 14 12 10 8 6,50,55,60,65,70,75,LE Bio,Age of
24、Implantation,Years,Source: ,LE Mech,EFLE Mech,EFLE Bio,Event-Free Life Expectancy,Aortic Valve Replacement,Recommendations Valve Choice,Clinical situation Patient preference,Clinical Recommendations Tissue Valve,Limited life expectancy Older Age CAD-severe LV dysfunction-severe Comorbidities-severe
25、Increased bleeding risk,Clinical Recommendations Mechanical Valve,Warfarin for other indication 60 years,Patient Preference Quality of Life,Mechanical valves: Freedom from SVD Greater freedom from reoperation Anticoagulation Bioprostheses: SVD and Reoperation. Freedom from anticoagulation and antico
26、agulation-related hemorrhage,Bioprostheses Mechanical Homograft,100 80 60 40 20,Aortic Valve Prostheses 1995-2005,%,1995,1997,1999,2005,2001,2003,100 80 60 40 20 0,80,2005 Isolated Aortic Valve Prosthesis by Age,Human Repair Mechanical Bioprostheses,Age,%,AVR Population,Age 1980-1995 62 years 1996 - 2005 73 years 70% of patients with CAD 15 % of patients 65 years,or,?,Valve Related Factors Durability Need for Anticoagulation Patient Related Factors Life Expectancy Preferences,