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Societies Offer Guidance on Clinical Utility of Circulatory Assist Devices

By L.A. McKeown

In light of increases in both the availability and use of percutaneous mechanical circulatory support devices, 4 medical societies recently issued an expert consensus paper to help physicians match the right device with the right patient.

The document, drafted by the Society for Cardiovascular Angiography and Interventions (SCAI), American College of Cardiology (ACC), Heart Failure Society of America (HFSA), and Society for Thoracic Surgeons (STS), was published online April 7, 2015, ahead of print in Catheterization and Cardiovascular Interventions and 2 other journals. Take Home: Societies Offer Guidance on Clinical Utility of Circulatory Assist Devices

In an email with TCTMD, committee member Srihari S. Naidu, MD, of Winthrop University Hospital (Mineola, NY), said the consensus statement aimed “to provide more granularity to the discussion of optimal use of support devices in the various relevant clinical settings.”

A writing panel led by Charanjit S. Rihal, MD, of the Mayo Clinic (Rochester, MN), synthesized available data on the use of and appropriate indications for axial flow pumps, like Impella (Abiomed); left atrial to femoral artery bypass pumps, like TandemHeart (CardiacAssist; Pittsburgh, PA); new extracorporeal membrane oxygenation (ECMO) devices; and intra-aortic balloon pumps (IABPs) for the treatment of high-risk patients.

According to the consensus-based recommendations, percutaneous circulatory assist devices:

  • Provide superior hemodynamic support compared with pharmacologic therapy
  • Can be considered for cardiogenic shock if placed early in those who fail to stabilize or show signs of improvement after initial interventions
  • Can be beneficial in high-risk PCI (eg, 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
  • Can be utilized when patients fail to wean off of cardiopulmonary bypass
  • May benefit patients with acute decompensated heart failure when used early in those who continue to deteriorate despite initial interventions
  • Can be used in severe biventricular failure via both right- and left-sided percutaneous devices or venoarterial ECMO
  • May be considered for isolated acute right ventricular failure complicated by cardiogenic shock
  • But the committee concluded that there was insufficient evidence to support or refute routine use of such devices as an adjunct to primary revascularization in large acute MI to reduce reperfusion injury or infarct size.

Beyond the Pump

According to the panel members, in emergent situations, such as STEMI, an IABP is often considered the quickest and most familiar way to obtain some degree of hemodynamic stabilization. This is especially true, they note, for acute MI with pump failure. But IABP use often requires concomitant pharmacologic support to maintain hemodynamics, and studies such as CRISP-AMI have raised questions about the efficacy and safety of IABP support in this setting.

Operators experienced with Impella, they say, “may elect to insert this device instead in such patients, in order to minimize or obviate pressor use, reduce myocardial oxygen demand, and improve systemic perfusion, thereby avoiding systemic shock.” At experienced centers, insertion of Impella 2.5 or Impella CP (Abiomed) may be as rapid as an IABP, the authors add.

“Operators must consider the advantages and disadvantages of initially selecting a device to achieve higher cardiac output by inserting it at the beginning of a high-risk procedure or at the early stages of [heart failure] or shock and perhaps obviating peripheral and coronary vasoconstriction that accompany vasopressor therapy,” the statement says.

“In patients with cardiogenic shock and mechanical complications, TandemHeart or Impella 5.0 offers the greatest cardiac output and hemodynamic support while the individual is evaluated for surgery,” it advises. “Inotropes may still be required to support RV function after placement of a left-sided support device. Patients with biventricular failure and/or impaired oxygenation may require ECMO support. Biventricular support with 2 different devices (eg, TandemHeart for RV support and Impella or IABP for LV support) has also been reported.”

For high-risk PCI, the committee members say more data are needed on subgroups that may benefit from support devices. Specifically, for patients with acute MI complicated by cardiogenic shock, they called for a phase III, multicenter, 3-arm study comparing outcomes with IABP, newer mechanical circulatory support devices, or neither that is powered to detect differences in not only short-term hemodynamics but also long-term survival.

Additionally, the document notes the re-emergence of ECMO use in cath labs at many centers.

Good Resource for Clinicians

In a telephone interview with TCTMD, Ajay J. Kirtane, MD, SM, of Columbia University Medical Center (New York, NY), said the document “does a reasonable job” of differentiating between options for mechanical circulatory support in patients with shock or undergoing high-risk interventions.

“One of the objectives of a document like this is identifying gaps in knowledge, which they have done,” he said. “That is especially important in this area because there is increasing interest in these devices and variability among them, so it’s important to [synthesize] what’s in the literature so [it] can inform future studies.”

Likewise, the panel concludes that registries and randomized controlled trials are “critically needed” to compare different strategies across clinical scenarios.

Most of the available data, Dr. Kirtane clarified, are nonrandomized.

“It behooves us as [interventional cardiologists] to try to identify which patients will benefit the most and which ought not have these devices,” he observed, adding that his own institution has a “shock team” and follows patients systematically, with the hope of tying outcomes to device utilization.

The bottom line is that clinicians need to know what the advantages are for their patients in using these devices, Dr. Kirtane added.

“For many of us in the interventional field, we are focused primarily on the coronaries, but when we look at the [whole picture] we realize that the coronaries are just a small part of the heart,” he said. “Some of the tables in this document are very useful for clinicians, because they lay out the combinations of ejection fraction and anatomy…. Too often we just proceed to coronary intervention when really we need to be looking at these individual parts of the clinical picture.”

 

Source:
Rihal CS, Naidu SS, Givertz MM, et al. 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 Cardiologia Intervencion; affirmation of value by the Canadian Association of Interventional Cardiology–Association Canadienne de Cardiologie d’intervention). Catheter Cardiovasc Interv. 2015;Epub ahead of print.

Disclosures:

  • Drs. Rihal and Naidu report no relevant conflicts of interest.
  • Dr. Kirtane reports institutional research grants from Abbott Vascular, Abiomed, Boston Scientific, Eli Lilly, Medtronic, St. Jude Medical, and Vascular Dynamics.

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