Mechanical circulatory support (MCS) evolved from an engineering dream to clinical
reality during the 1980s when increasing numbers of patients were dying on heart transplant
wait lists. Following the Randomized Evaluation of Mechanical Assistance for the Treatment
of Congestive Heart Failure Trial,
1
the US Food and Drug Administration (FDA) approved a pulsatile implantable left ventricular
assist device (LVAD) for long-term implantation in 2002. When the FDA approved the
first US continuous flow (CF) LVAD in 2008, the landscape had changed dramatically.
With demonstrated survival on device exceeding 80% at 1 year,
2
implants in the United States progressively increased to nearly 3000 per year. With
the maturation of this field, guidelines for patient care and decision making have
become more evidenced-based. This consensus guidelines document focuses on selected
topics in patient management. The writing group included 25 surgeons and 10 heart
failure cardiologists. After review and evaluation of available literature and incorporation
of their collective experience, specific recommendations were assigned a class and
level of evidence (Table 1).
3
,4
Table 1American Association for Thoracic Surgery/International Society for Heart and Lung
Transplantation Guidelines Grading Criteria
3
,4
Class I | Evidence and/or general agreement that a given treatment or procedure is beneficial, useful, and effective |
Class II | Conflicting evidence and/or divergence of opinion about the usefulness/efficacy of the treatment or procedure |
Class IIa | Weight of evidence/opinion is in favor of usefulness/efficacy |
Class IIb | Usefulness/efficacy is less well established by evidence/opinion |
Class III | Evidence or general agreement that the treatment or procedure is not useful or effective and in some cases may be harmful |
Level of Evidence A | Data derived from multiple randomized clinical trials or meta-analyses |
Level of Evidence B | Data derived from a single randomized clinical trial or large non-randomized studies |
Level of Evidence C | Consensus of opinion of the experts and/or small studies, retrospective studies, registries |
KeyWords
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Article info
Publication history
Published online: January 23, 2020
Footnotes
This article has been copublished in The Journal of Thoracic and Cardiovascular Surgery and the Journal of Heart and Lung Transplantation.
Identification
Copyright
© Published by Elsevier Inc. on behalf of International Society for Heart and Lung Transplantation.