Societies Release Consensus Document on Percutaneous Circulatory Support Devices

Marlene Busko

April 09, 2015

ROCHESTER, MN — In a joint consensus statement, experts from multiple societies provide guidance for using currently available percutaneous mechanical circulatory support devices in typical clinical scenarios[1]. The document not only fills a gap in existing guidelines, it also highlights the need for a registry to provide more knowledge about the clinical use of newer devices, lead author Dr Charanjit S Rihal (Mayo Clinic, Rochester, MN) told heartwire from Medscape.

The statement—from the Society for Cardiovascular Angiography and Interventions (SCAI), Heart Failure Society of America (HFSA), Society for Thoracic Surgeons (STS), American Heart Association (AHA), and American College of Cardiology (ACC)—was published online April 7, 2015, in Catheterization and Cardiovascular Interventions.

The use of the intra-aortic balloon pump is decreasing, while the use of new mechanical circulatory support devices—such as the Impella axial flow pump (Abiomed), the TandemHeart left atrial–femoral artery bypass pump (CardiacAssist), and new devices for institution of extracorporeal membrane oxygenation—is increasing in the US, Rihal explained.

Based on limited clinical-trial evidence, the 2011 ACC/AHA/SCAI guidelines for PCI recommend consideration of percutaneous mechanical circulatory support devices in two clinical settings: as an adjunct to high-risk PCI (class IIb) and for cardiogenic shock in patients presenting with STEMI (class Ib).

The group of experts convened to "fill the gap between the commercial availability of the devices, the relative lack of [clinical-trial] data . . . and the relative lack of comments in the national guidelines," Rihal said.

The report provides a table that summarizes nine suggested indications for these devices: complications of acute MI; severe heart failure in the setting of nonischemic cardiomyopathy; acute cardiac allograft failure in an adults or children; posttransplant right ventricular failure; patients slow to wean from cardiopulmonary bypass following heart surgery; refractory arrhythmias; prophylactic use for high-risk PCI; high-risk or complex ablation of ventricular tachycardia; and high-risk percutaneous valve interventions.

The authors also make several recommendations, including:

  • Early placement of mechanical circulatory support devices may be considered for:

    • Patients with cardiogenic shock who fail to stabilize or show signs of quick improvement after early interventions.

    • Patients undergoing high-risk PCI.

    • Patients with acute decompensated heart failure who continue to deteriorate.

    • Patients who fail to wean off cardiopulmonary bypass.

  • Devices such as the Impella and TandemHeart should remain clinically available and appropriately reimbursed, since they provide better hemodynamic support than pharmacotherapy.

  • For patients with profound cardiogenic shock, the intra-aortic balloon pump is less likely to provide benefit than a continuous-flow pump, including the Impella CP and TandemHeart.

"The most important [recommendation] is the call for a national registry, analogous to the Society of Thoracic Surgeons (STS) and ACC Transcatheter Valve Therapy (TVT) Registry or the National Cardiovascular Data Registry (NCDR) Peripheral Vascular Interventions (PVI) Registry, so that we can get systematic data and really understand the outcomes of the patients in whom we're using these devices," according to Rihal.

As well as helping to guide clinical practice, the statement also provides a framework for adding findings from new trials and new device approvals, he said.

Rihal has reported no relevant financial relationships. Disclosures for the coauthors and committee members are listed in the article.

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