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Mechanical Circulatory Support

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vel of Evidence CLASS IIb Benefit ≥ Risk Additional studies with broad objectives needed; additional registry data would be helpful Procedure/Treatment MAY BE CONSIDERED CLASS III No Benefit or CLASS III Harm COR III: No benefit COR III: Harm Procedure/ Test Treatment Not Helpful No Proven Benefit Excess Cost w/o Benefit   or Harmful Harmful to Patients ▪Recommendation's usefulness/efficacy less well established ▪Recommendation that procedure or treatment is not useful/effective and may be harmful ▪Greater conflicting evidence from multiple randomized trails or meta-analyses ▪Sufficient evidence from multiple randomized trials of meta-analyses ▪Recommendation's usefulness/efficacy less well established ▪Recommendation that procedure or treatment is not useful/effective and may be harmful ▪Greater conflicting evidence from single randomized trial or nonrandomized studies ▪Evidence from single randomized trial or nonrandomized studies ▪Recommendation's usefulness/efficacy less well established ▪Recommendation that procedure or treatment is not useful/effective and may be harmful ▪Only diverging expert opinion, case studies, or standard of care ▪Only expert opinion, case studies, or standard of care may/might be considered may/might be reasonable usefulness/effectiveness is unknown/unclear/ uncertain or not well established COR III: No benefit is not recommended is not indicated should not be performed/ administered/other is not useful/beneficial/ effective a COR III: Harm potentially harmful causes harm associated with excess morbidity/mortality should not be performed/ administered/other Data available from clinical trials or registries about the usefulness/efficacy in different subpopulations, such as sex, age, history of diabetes, history of prior myocardial infarction, history of heart failure, and prior aspirin use. For comparative effectiveness recommendations (Class I and IIa; Level of Evidence A and B only), studies that support the use of comparator verbs should involve direct comparisons of the treatments or strategies being evaluated. b

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