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

ECMO, LVADs, and the ethics of innovative surgery with innovative devices ;Central tension: science v. ethics ;We regulate ourselves, sorta;Berlin heart;Regulatory approvals;But what do we really know?; Age (months) Mean ± Std 15.4 ± 12.4 18.5 ± 11.5 0.29 Median 11.7 16.1 Min – Max 2.6 - 45.6 1.8 – 43.7 /downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/CirculatorySystemDevicesPanel/UCM263039.pdf ;Many SAEs with BH;Better survival than ECMO(Cohort I – smaller babies);Survival – Cohort II;Data seems compelling;All who drink of this treatment recover within a short time, except in those who do not. Therefore, it fails only in incurable cases --Galen;The challenge;Analogies between ECMO and the Berlin Heart (or other VADs);Historical development of ECMO;Bartlett’s survival rates;ECMO in the 1980s;International differences;Multicentre RCT in UK;Results of UK trial;The ECMO debate;Two responses to the trial;The dilemma;The dilemma;Equipoise: a contentious concept;The paradox of equipoise;The inescapable conclusion;The way things are;Two moral imperatives;Just because it is not an RCT….;Fallacies to avoid