Societies Release New Guidance on Percutaneous Mechanical Support Devices

April 7, 2015—A multisociety expert consensus statement providing new guidance on percutaneous mechanical circulatory support (MCS) to help physicians match the right device with the right patient was released by the Society for Cardiovascular Angiography and Interventions (SCAI), American College of Cardiology (ACC), Heart Failure Society of America (HFSA), and the Society of Thoracic Surgeons (STS). The article titled, “SCAI/ACC/HFSA/STS Clinical Expert Consensus Statement on the Use of Percutaneous Cardiac Assist Devices in Cardiovascular Care” was drafted by lead author Charanjit S. Rihal, MD, et al, and published in Catheterization and Cardiovascular Interventions, the Journal of the American College of Cardiology, and the Journal of Cardiac Failure. It is available online at www.scai.org, www.acc.org, www.hfsa.org, and www.sts.org.

The statement has been endorsed by the American Heart Association, Cardiological Society of India, and the Latin American Society of Interventional Cardiology. Additionally, the Canadian Association of Interventional Cardiology has affirmed the value of the statement.

In the societies’ announcement Dr. Rihal commented, “Percutaneous mechanical circulatory support is revolutionizing the treatment of high-risk cardiac patients. In certain patients, these devices can mean the difference between recovery and the need for heart transplant or death, and they may be used to maintain hemodynamic stability during interventional procedures and as a bridge to longer-term treatment. The new consensus statement will help physicians select devices for the patients who are most likely to benefit.” Dr. Rihal is Chair of the Division of Cardiovascular Diseases at the Mayo Clinic in Rochester, Minnesota.

To develop the new recommendations, a panel of experts reviewed scientific data on all of the available devices, including intra-aortic balloon pumps, left atrial-to-aorta assist devices (TandemHeart, CardiacAssist, Inc.), left ventricle-to-aorta assist devices (Impella, Abiomed, Inc.), extracorporeal membrane oxygenation, as well as methods for right-sided heart support. 

The expert panel also reviewed indications for percutaneous MCS, including complications of heart attack, high-risk angioplasty and stenting (percutaneous coronary intervention), and advanced heart failure and cardiogenic shock.

The statement advised that based on the available data and anticipated benefits and risks, the panel determined that percutaneous MCS provides superior circulatory support compared to medical therapy, especially when using left ventricular assist devices. Early use of MCS can benefit patients in cardiogenic shock when initial interventions fail to stabilize the patient. MCS may also benefit high-risk percutaneous coronary intervention patients and certain patients with acute decompensated heart failure whose symptoms are worsening despite treatment. MCS may also be used in those who have failed to wean off of a heart-lung bypass machine. The evidence does not support routine use of MCS in heart attack patients.  

Srihari S. Naidu, MD, Vice Chair of the consensus document’s writing committee, commented, “MCS utilization is clearly increasing, and this document should assist clinicians in recognizing when early support is needed and what that support should look like.” Dr. Naidu is Director of the cardiac catheterization lab at Winthrop University Hospital in Mineola, New York.

The expert consensus statement also highlights emerging treatment opportunities, such as for patients undergoing percutaneous valve replacement who have severe, nonoperable valve disease, as well as some patients undergoing electrophysiological procedures. Currently, most percutaneous MCS devices cannot be used in children due to size limitations, but the statement notes that this is an important area for future development. Registries and randomized controlled trials are also critically needed to compare different devices and treatment strategies across patient populations, advised the societies.