那些患者适合行血管内瓣膜植入术

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 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 459 patients enrolled ( 45%) 2,000 implants CoreValve Revalving System Commercial 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? 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 Surgery 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 Thoracic 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 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 mortality 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 Frailty/ 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 Risk of AVR Same age (90) and predicted risk (12%) One 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 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 “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 impairment 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 Risk/Non- Operable Symptomatic, Critical Calcific Aortic Stenosis No Not in Study No VS Trans apical AVR Control 1:1 Randomization Cohort A TA Powered to be Pooled with TF Yes Cohort B NoASSESSMENT: Operability Cohort An= up to 690 pts n=350 pts Total n= 1040 ASSESSMENT: Transfemoral Access Trans femoral AVR Control VS Yes 1:1 Randomization Cohort A TF Powered Independently Primary Endpoint: All Cause Mortality (Non-inferiority) Medical Management Control ASSESSMENT: Transfemoral Access VS Trans femoral 1:1 Randomization Yes Primary Endpoint: All Cause Mortality (Superiority) 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 Enrolled 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 Nove