Author + information
- Received October 15, 2014
- Accepted October 25, 2014
- Published online May 19, 2015.
- Charanjit S. Rihal, MD, FSCAI, FACC1,∗∗ (, )
- Srihari S. Naidu, MD, FSCAI, FACC, FAHA2,
- Michael M. Givertz, MD, FACC3,
- Wilson Y. Szeto, MD4,
- James A. Burke, MD, PhD, FACC5,
- Navin K. Kapur, MD6,
- Morton Kern, MD, MSCAI, FACC7,
- Kirk N. Garratt, MD, FSCAI, FACC8,
- James A. Goldstein, MD, FSCAI, FACC9,
- Vivian Dimas, MD10,
- Thomas Tu, MD11,
- Society for Cardiovascular Angiography and Interventions (SCAI), Heart Failure Society of America (HFSA), Society of Thoracic Surgeons (STS), American Heart Association (AHA), and American College of Cardiology (ACC)
- 1Division of Cardiovascular Diseases, Mayo Clinic, Rochester, Minnesota
- 2Division of Cardiology, Winthrop University Hospital, Mineola, New York
- 3Cardiovascular Division, Brigham and Women’s Hospital, Boston, Massachusetts
- 4Department of Surgery, University of Pennsylvania, Philadelphia, Pennsylvania
- 5Division of Cardiology, Lehigh Valley Heart Specialists, Allentown, Pennsylvania
- 6Cardiology, Tufts Medical Center, Boston, Massachusetts
- 7Division of Cardiology, UCI Medical Center, Orange, California
- 8Department of Cardiac and Vascular Services, Heart and Vascular Institute of New York, Lenox Hill Hospital, New York, New York
- 9Division of Cardiology, Beaumont Heart Center Clinic, Royal Oak, Michigan
- 10Pediatric Cardiology, UT Southwestern, Dallas, Texas
- 11Louisville Cardiology Group, Interventional Cardiology, Louisville, Kentucky
- ↵∗∗Correspondence to: Charanjit S. Rihal, MD, Mayo Clinic, 200 First Street S.W., Rochester, MN 55905.
- ACC Expert Consensus Documents cardiogenic shock
- percutaneous coronary intervention
- ventricular assist device
This article provides a brief summary of the relevant recommendations and references related to percutaneous mechanical circulatory support. The goal was to provide the clinician with concise, evidence-based contemporary recommendations, and the supporting documentation to encourage their application. The full text includes disclosure of all relevant relationships with industry for each writing committee member. A fundamental aspect of all expert consensus statements is that these carefully developed, evidence-based documents can neither encompass all clinical circumstances, nor replace the judgment of individual physicians in management of each patient. The science of medicine is rooted in evidence, and the art of medicine is based on the application of this evidence to the individual patient. This expert consensus statement has adhered to these principles for optimal management of patients requiring percutaneous mechanical circulatory support.
Although historically the intra-aortic balloon pump has been the only mechanical circulatory support device (MCS) available to clinicians, a number of new devices have become commercially available and have entered clinical practice. These include axial flow pumps, such as Impella®; left atrial to femoral artery bypass pumps, specifically the TandemHeart; and new devices for institution of extracorporeal membrane oxygenation (ECMO). These devices differ significantly in their hemodynamic effects, insertion, monitoring, and clinical applicability. The full text document reviews the physiologic impact on the circulation of these devices and their use in specific clinical situations (1). These situations include patients undergoing high-risk percutaneous coronary intervention (PCI), those presenting with cardiogenic shock, and acute decompensated heart failure. Specialized uses for right-sided support and in pediatric populations are discussed. The clinical utility of MCS devices is reviewed as are the American College of Cardiology/American Heart Association clinical practice guidelines.
We provide the following consensus-based recommendations based on the anticipated hemodynamic effects and risks, clinical outcomes data as well as knowledge gaps.
1. Percutaneous MCS provides superior hemodynamic support compared to pharmacologic therapy. This is particularly apparent for the Impella and Tandem-Heart devices. These devices should remain available clinically and be appropriately reimbursed.
2. Patients in cardiogenic shock represent an extremely high-risk group in whom mortality has remained high despite revascularization and pharmacologic therapies. Early placement of an appropriate MCS may be considered in those who fail to stabilize or show signs of improvement quickly after initial interventions.
3. MCS may be considered for patients undergoing high-risk PCI, such as those requiring multivessel, left main or last patent conduit interventions, particularly if the patient is inoperable or has severely decreased ejection fraction or elevated cardiac-filling pressures.
4. In the setting of profound cardiogenic shock, intra-aortic balloon pump (IABP) is less likely to provide benefit than continuous flow pumps including the Impella CP and TandemHeart. ECMO may also provide benefit, particularly for patients with impaired respiratory gas exchange.
5. Patients with acute decompensated heart failure may benefit from early use of percutaneous MCS when they continue to deteriorate despite initial interventions. MCS may be considered if patients are candidates for surgically implanted ventricular assist device (VAD) or if rapid recovery is expected (e.g., fulminant myocarditis or stress-induced cardiomyopathy).
6. When oxygenation remains impaired, adding an oxy-genator to a TandemHeart circuit or use of ECMO should be considered based on local availability.
7. There are insufficient data to support or refute the notion that routine use of MCSs as an adjunct to primary revascularization in the setting of large acute myocardial infarction is useful in reducing reperfusion injury or infarct size. Exploratory studies are underway.
8. MCSs may be used for failure to wean off cardio-pulmonary bypass, considered as an adjunct to high-risk electrophysiologic procedures when prolonged hypotension is anticipated or, rarely, for valvular interventions.
9. Severe biventricular failure may require use of both right- and left-sided percutaneous MCS or veno-arterial ECMO. Certain patients may respond to left ventricular assist device (LVAD) implantation with inotropes and/or pulmonary vasodilators to support the right heart. MCS may also be considered for isolated acute right ventricular failure complicated by cardiogenic shock.
10. Registries and randomized controlled trials comparing different strategies in different clinical scenarios are critically needed.
11. Early analyses suggest cost-effectiveness of MCS for emergent use in comparison to surgical ECMO or VAD support, and for elective use in comparison to IABP. Further data are necessary.
↵∗ The Canadian Association of Interventional Cardiology (CAIC) is approached by other guideline developers and asked to review and consider guidelines for endorsement. Guidelines developed by external organizations will be considered for affirmation of value. The CAIC may not agree with every recommendation in such a document, but overall considers the document to be of educational value to its members.
The American College of Cardiology requests that this document be cited as follows: Rihal CS, Naidu SS, Givertz MM, Szeto WY, Burker JA, Kapur NK, Kern M, Garratt KN, Goldstein JA, Dimas V, Tu T. Executive summary: 2015 SCAI/ACC/HFSA/STS clinical expert consensus statement on the use of percutaneous mechanical circulatory support devices in cardiovascular care (endorsed by the American Heart Association, the Cardiological Society of India, and Sociedad Latino Americana de Cardiología Intervencionista; affirmation of value by the Canadian Association of Interventional Cardiology—Association Canadienne de Cardiologie d′intervention). J Am Coll Cardiol 2015;65:2140–1.
The document will also appear in the Journal of Cardiac Failure and Catheterization and Cardiovascular Interventions.
Copies: This document is available on the World Wide Web sites of the Society for Cardiovascular Angiography and Interventions (www.scai.org), the American College of Cardiology (www.cardiosource.org), Heart Failure Society of America, and the Society of Thoracic Surgeons (www.sts.org). For copies of this document, please contact Elsevier Inc. Reprint Department, fax 212-462-1935, or e-mail .
Permissions: Multiple copies, modification, alteration, enhancement, and/or distribution of this document are not permitted without the express permission of the American College of Cardiology. Requests may be completed online via the Elsevier site (http://www.elsevier.com/about/policies/author-agreement/obtaining-permission).
- Received October 15, 2014.
- Accepted October 25, 2014.
- 2015 The Society for Cardiovascular Angiography and Interventions, The American College of Cardiology Foundation, the Heart Failure Society of America, and The Society of Thoracic Surgeons
- Rihal C.S.,
- Naidu S.S.,
- Givertz M.M.,
- et al.