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1、那些患者适合行血管内瓣膜植入术?,Michael Mack, M.D. Dallas, TX,Cribier et al. Circulation 2002;106:3006-3008,经导管主动脉瓣植入术,CoreValve,Edwards Sapien THV,经股动脉 (TF),经心尖(TA),经导管主动脉瓣植入术 临床经验,Edwards Sapien THV 欧洲患者能够承受和的费用 TF 和TA在美国重点试验范围内 (PARTNER) 459 例患者 ( 45%) 2,000 移植物 CoreValve 瓣膜置换系统 既往都是无对照的病例研究 US IDE 试验即将开展 2,000
2、 移植物,那些患者适合行经导管?,无法手术的患者 高危的手术患者,问题,是否有无法手术的主动脉狭窄患者? 非常高危的手术患者是否能够被发现?,问题,是否有无法手术的主动脉狭窄患者? 非常高危的手术患者是否能够被发现?,We dont turn down anyone!,心内科医生- 是! 但是我们见到的患者中，至少有的患者没有被转诊,外科医生对主动脉狭窄的看法,“无法手术” 是指 ,结论 严重的有症状的老年患者中有的患者被拒绝手术治疗。高龄和左室功能障碍是被拒绝进行手术的最常见的原因，而其他的并发症影响并不是特别大,1993-2003 740 患者 AVA 0.8cm2 287 (38.7%)
3、行 AVR,Annals Thoracic Surgery, 2006,问题,是否有无法手术的主动脉狭窄患者? 非常高危的手术患者是否能够被发现?,单纯主动脉瓣置换 手术死亡率 -STS Database,STS 单纯根据年龄的死亡风险 预测,%死亡率,年龄,主动脉瓣手术 风险预测方法,STS EuroSCORE (相加) EuroSCORE (对数) Ambler (UK) Northern New England New York State Providence Health System,风险预测方法中存在的问题,所有的风险计算法都以术后患者为基础，并不包括无法手术的患者 对天后的死亡
4、率和预后没有进行预测 出院后情况和生活质量没有预测 许多风险变量没有纳入,危险因素没有纳入到风险计算法,陶瓷样主动脉 既往纵隔放疗史(淋巴瘤) 既往多次开胸行开放式置换术史 严重的肝脏疾病史/ 肝硬化 虚弱/ 衰竭 无法活动,我们如何评估风险 ?,主动脉诊所 2-3 心脏病学家 2-3 外科医生 2 研究协调者,AVR的风险,年龄 (90) 和危险因素相同 糖尿病，房颤 高血压，轻度的肾功能受损,sts.org,AVR的风险,年龄 (90) 和预计风险 (12%)相同 一位通过“眼球试验”，另一位没通过,由于多个生理系统机能下降导致对外界应激因子的抵抗能力及储备下降的生物学综合征，从而使机体对
5、不良事件的耐受能力下降。,什么是衰弱?,Fried LP et al, J Gerontology 2001;56A:M146-56,Craig Smith, M.D.,衰弱的指标,已经在老年群体中得到证实 在6-12个月内与死亡率相关性很好 在主动脉狭窄的患者中没有得到证实 在手术预后中没有得到证实,副作用 ( Death or Institutionalization) 根据 “虚弱指数”,Craig Smith, M.D.,临床虚弱指数 (1-7),日常活动能力 (Katz) 洗澡, 进食, 穿着 虚弱表型 体力活动 体力水平 体能测试 握力 (握力器) 从椅子上站立 4 米不行距离 试
6、验室 Albumin FEV1 Cr Cl BNP,健康状况没有受损,完全依靠护理人员，无法活动,1,7,AVR风险,年龄90 STS 风险12% 虚弱指数,年龄90 STS 风险 12% 虚弱指数 1,PARTNER IDE 试验,Co-principal Investigators: Martin B. Leon, MD Interventional Cardiology Craig Smith, MD, Cardiac Surgeon Columbia University,Population: High Risk/Non-Operable Symptomatic, Critical
7、Calcific Aortic Stenosis,Two Trials: Individually Powered Cohorts (Cohorts A & B),Update SEPT 2008,PARTNER 经导管AVR试验 Dallas Screening Log 2006-2008 n=292,经导管主动脉瓣植入术 Dallas - August, 2006- October, 2008,筛查 292 纳入试验 70 (25%) 排除 99 (36%) 死亡 51 (19%) Declined Participation 40 (14%) 传统 AVR 74 (26%) 行BAVs
8、术 30 (11%) 未治疗的主要原因 “虚弱”,Ann Thorac Surg November 2008,总结,有一些患者以往认为“无法手术” 高危患者和无法手术的患者是能够被确认的 STS 风险是手术预后的最佳评估指标 许多因素包括虚弱没有包括在风险计算法中,Who is a Candidate for an Endovascular Valve?,Michael Mack, M.D. Dallas, TX,Cribier et al. Circulation 2002;106:3006-3008,Transcatheter Aortic Valve Implantation,CoreV
9、alve,Edwards Sapien THV,Transfemoral (TF),Transapical (TA),Transcatheter Aortic Valves Clinical Experience,Edwards Sapien THV Commercial Approval in Europe for TF and TA Approaches TF and TA in US Pivotal Trial (PARTNER) 459 patients enrolled ( 45%) 2,000 implants CoreValve Revalving System Commerci
10、al Approval in Europe for TF Anecdotal TA cases US IDE Trial imminent 2,000 implants,Who Are Suitable Candidates for Transcatheter AVR ?,Inoperable Patients High Risk Operable Patients,Questions,Are there “inoperable” patients with aortic stenosis? Can “very high risk” patients for AVR be identified
11、?,Questions,Are there “inoperable” patients with aortic stenosis? Can “very high risk” patients for AVR be identified?,We dont turn down anyone!,Cardiologist- True! But we never refer at least 1/3 of the patients with AS we see,Surgeons View of Aortic Stenosis,“Inoperable” is in the ,Conclusion Surg
12、ery was denied in 33% of elderly patients with severe, symptomatic AS. Older age and LV dysfunction were the most striking characteristics of patients who were denied surgery, whereas comorbidity played a less important role.,1993-2003 740 patients with AVA 0.8cm2 287 (38.7%) underwent AVR,Annals Th
13、oracic Surgery, 2006,Questions,Are there “inoperable” patients with aortic stenosis? Can “very high risk” patients for AVR be identified?,Isolated Aortic Valve Replacement Operative Mortality-STS Database,STS Predicted Risk of Mortality with AVR Based on Age Alone,%Mortality,Age,Aortic Valve Surgery
14、 Predictive Risk Algorithms,STS EuroSCORE (additive) EuroSCORE (logistic) Ambler (UK) Northern New England New York State Providence Health System,Problems with Risk Algorithms,All risk algorithms are based on operated patients and dont factor in “inoperable “ patients Outcomes other than 30 day mor
15、tality are not predicted Discharge disposition, Quality of Life not predicted Many risk variables not included,Risk Factors Not Included in Risk Algorithms,Porcelain Aorta Previous Mediastinal Radiation (Lymphoma) Multiple Previous Sternotomies With Open Grafts Advanced Liver Disease/ Cirrlosis Frai
16、lty/ Debility/ Immobility,How Do We Evaluate Risk ?,Aortic Valve Clinic 2-3 Cardiologists 2-3 Surgeons 2 Research Coordinators,Risk of AVR,Same age (90) and risk factors Diabetes, atrial fibrillation, hypertension, mild renal insufficiency,sts.org,Risk of AVR,Same age (90) and predicted risk (12%) O
17、ne passes the “eyeball test”; one doesnt,A biologic syndrome of decreased reserve and resistance to stressors, resulting from cumulative declines across multiple physiologic systems, and causing vulnerability to adverse outcomes.,What is Frailty?,Fried LP et al, J Gerontology 2001;56A:M146-56,Craig
18、Smith, M.D.,Frailty Indices,Well documented and validated in geriatric populations Correlate well with death or institutionalization within 6-12 months Not validated in patients with aortic stenosis Not validated in post procedural outcomes,Adverse Outcomes ( Death or Institutionalization) Based on
19、“Fraility Index”,Craig Smith, M.D.,Clinical Frailty Index (1-7),Activities of Daily Living (Katz) Bathing, feeding, dressing Frailty Phenotype Physical Activity Energy level Physical Performance Tests Grip strength (dynanometer) Chair rise 4 meter walk Labs Albumin FEV1 Cr Cl BNP,Healthy,no impairme
20、nt,Totally dependent on caregivers, immobile,1,7,Risk of AVR,Age 90 STS Risk 12% Frailty Index 7,Age 90 STS Risk 12% Frailty Index 1,The PARTNER IDE Trial,Co-principal Investigators: Martin B. Leon, MD Interventional Cardiology Craig Smith, MD, Cardiac Surgeon Columbia University,Population: High Ri
21、sk/Non-Operable Symptomatic, Critical Calcific Aortic Stenosis,Two Trials: Individually Powered Cohorts (Cohorts A & B),Update SEPT 2008,PARTNER Transcatheter AVR Trial Dallas Screening Log August 2006-October 2008 n=292,Transcatheter Aortic Valve Dallas - August, 2006- October, 2008,Screened 292 En
22、rolled in Trial 70 (25%) Excluded 99 (36%) Deceased 51 (19%) Declined Participation 40 (14%) Conventional AVR 74 (26%) BAVs Performed 30 (11%) Main reason for non-intervention- “frailty”,Ann Thorac Surg November 2008,Summary,There is a patient population traditionally considered “inoperable” High risk and inoperable patients can be defined STS Risk is best predictor of surgical outcomes Many factors includin frailty are not accounted for in risk prediction algorithms,