(精编)【体外膜肺ECMO精品课件】 ECMO, LVADs, and the ethics of innovative surgery with innovative devices教学课件.pptVIP

John D. Lantos M.D. Children’s Mercy Bioethics Center University of Missouri – Kansas City @COPYRIGHT 2012 Central tension: science v. ethics How much to modify the science in order to meet the demands of ethics. We want progress We want to not harm people in the process’ We have our own conflicts We want to make money, get famous, be respected, earn the gratitude of suffering families, etc. We regulate ourselves, sorta Well-defined system for new drugs. Less well-defined system for new devices. No system for new operations. VADS: New operations using new devices. i.e. an ethical and regulatory morass. Berlin heart A paracorporeal pulsatile device Stroke volumes of 10, 25, 30, 50, and 60 ml Synchronous, asynchronous, and independent modes Rechargeable 5hr battery Can be used as outpatient device. Univentricular (right or left) or biventricular support. But what do we really know? Do we know enough? Was the approval process appropriately cautious? Or idiotically risk-averse? What will happen now? (In the US, unlike Europe or Canada, once something is approved, the free market takes over.) Good science (gold standard): Prospective RCT Impossible with BH: Patients are at death’s door. Often already on ECMO. Nobody would agree to be randomized. So what was the basis for approval? Berlin heart vs. an historical control group that received ECMO. ECMO group matched in age, size, and illness severity with BH group. Two cohorts, (BSA 0.7, 0.7) /downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/CirculatorySystemDevicesPanel/UCM263039.pdf Age at initiation 0 - 30 days 0 (0%) 0 (0%) 0.1 30d – 2yrs 20 (83%) 30 (62%) 2 to 10yrs 4 (17%) 18 (37%) 10 to 16yrs 0 (0%) 0 (0%) /downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/CirculatorySystemDevicesPanel/UCM263039.pdf Berlin heart ECMO p- value Berlin Heart patients you