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Expert consensus statement addresses expanding options for percutaneous mechanical support devices
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Several new percutaneous mechanical circulatory support devices have become available for use in clinical practice in recent years, prompting four expert societies to release guidance outlining use of these devices in specific clinical situations.
Such devices include the traditionally used intra-aortic balloon pump, as well as newer axial flow pumps, left atrial to femoral artery bypass pumps and others for institution of extracorporeal membrane oxygenation (ECMO), according to the statement by the American College of Cardiology Foundation, the Heart Failure Society of America, the Society for Cardiovascular Angiography and Interventions, and the Society for Thoracic Surgery.
Srihari S. Naidu
“Each one of these devices has a risk profile unique to that technology,” writing committee vice chair Srihari S. Naidu, MD, FSCAI, FACC, FAHA, director of the cardiac catheterization laboratory, interventional cardiology fellowship program and Hypertrophic Cardiomyopathy Treatment Center at Winthrop University Hospital in Mineola, New York, told Cardiology Today’s Intervention. “There were questions about when to use one device over the other. Without a large amount of scientific evidence in this field, clinicians have had very little to guide them.”
Summary of 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 such as the TandemHeart (CardiacAssist), left ventricle to aorta assist devices such as the Impella (2.5, 5.0 and CP, Abiomed), ECMO and methods for right-sided heart support.
Based on available data, percutaneous mechanical devices are superior to pharmacologic therapy for circulatory support. The greatest benefits have been observed with the Impella and TandemHeart devices, according to the statement. The authors called for continued clinical availability and appropriate reimbursement of these devices.
Early placement of mechanical circulatory support may benefit patients in cardiogenic shock if other initial interventions such as revascularization and pharmacologic therapies fail to stabilize the patient quickly. In patients with profound cardiogenic shock, the Impella CP and TandemHeart or ECMO may provide more benefit than intra-aortic balloon pumps, especially for patients with impaired respiratory gas exchange, according to the statement.
“Mortality rates are 50% or higher for patients with cardiogenic shock. Advice on earlier initiation of percutaneous mechanical circulatory support devices in this patient population may move the needle in a positive direction,” Naidu said.
Percutaneous mechanical circulatory support may also be considered in unstable, high-risk PCI patients, such as those with multivessel or left main disease or those who require last patent conduit interventions; certain patients with acute decompensated HF whose symptoms continue to worsen despite treatment; patients who failed to wean off a heart-lung bypass machine; patients who are candidates for surgically implanted ventricular assist devices; as an adjunct to high-risk electrophysiologic procedures if prolonged hypotension is anticipated; and as an adjunct to valvular interventions, in rare cases, according to the statement.
The authors noted that there are insufficient data to validate or rule out routine use of percutaneous mechanical circulatory support for patients with acute MI.
Addition of an oxygenator to a TandemHeart circuit or ECMO can be considered when oxygenation remains impaired.
Current use, future directions
Although data on the aforementioned devices and clinical situations are not robust, there was enough information for a consensus statement, Naidu said. Several tables throughout the document show the merits of each device and recommended scenarios for use. “We think this will be useful for clinicians,” he said.
However, “registries and randomized controlled trials comparing different strategies in different clinical scenarios are critically needed,” according to the statement. In addition, “given the limited prospective, randomized, multicenter data with mechanical circulatory support use, these recommendations must be tempered with an understanding of knowledge gaps.”
For example, current gaps in knowledge include the effects of percutaneous mechanical circulatory support on left ventricular stroke work and myocardial oxygen demand in acute MI, in subgroups of high-risk patients undergoing PCI and its use for myocyte preservation during acute ischemic insult. The authors also noted that a study comparing outcomes with intra-aortic balloon pumps, mechanical circulatory support or neither device as well as further development and data on right ventricular support devices are warranted. – by Rob Volansky
Disclosure: Naidu reports serving on the scientific advisory board for Abbott Vascular, Abiomed, Gilead and The Medicines Company.
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