PVAD, percutaneous VAD, hemodynamic support, aortix

Percutaneous ventricular assist (pVAD) devices offer more hemodynamic support than the 40-year-old gold standard of intra-aortic balloon pumps (IABPs), but their cost and complexity has limited their use to all but the sickest patients. However, the quest for improving patient outcomes and new applications of pVADs for right ventricular support and heart failure indications continues to expand interest in these devices. Several of these new technologies were highlighted in sessions during the 2013 Transcatheter Cardiovascular Therapeutics (TCT) last fall.

 

I have watched a trend in medical technology grow from a small ripple a couple years ago into what I expect will be a tidal wave in 2014 due to growing concern over patient radiation dose levels from medical imaging. Use of radiation dose monitoring software came to the forefront when California, followed by Texas, created laws requiring medical facilities to record the amount of exposure patients receive from things like computed tomography (of which cardiac exams are among the highest dose levels used) and angiography. Adoption of this software will be further accelerated by new Joint Commission standards released in December 2013, which starting in mid-2014 requires the use of radiation dose monitoring software as part of its accreditation.

 

St. Jude Medical Inc. announced the first enrollments in the company’s LEADLESS Pacemaker Observational Study evaluating the Nanostim leadless pacing technology. The Nanostim pacemaker received CE marking in 2013, and post-approval implants have occurred in the United Kingdom, Germany, Italy, Czech Republic, France, Spain and the Netherlands.

By Dave Fornell, editor

Lumedx Corp. is a provider of vendor-neutral cardiovascular imaging and information systems (CVIS). It announced it has contracted to provide Phoebe Putney Memorial Hospital with a comprehensive CVIS that will integrate patient data and images across five different sites. The Lumedx CVIS will consolidate data, improve physician access to patient information, streamline clinical workflows, and support outcomes analysis and registry reporting for the Phoebe Heart and Vascular Center.

Thoratec Corp. initiated a voluntary worldwide Medical Device Correction in order to update its labeling and training materials for the HeartMate II LVAS Pocket System Controller. The following information is provided as a reinforcement of the initial release.

Patients with coronary artery disease who received an Endeavor or Resolute drug-eluting stent from Medtronic Inc. and subsequently interrupted their dual antiplatelet therapy (DAPT) earlier than current guidelines recommend experienced no increased risk of stent thrombosis at one year or more of follow up. Both devices elute the drug zotarolimus to reduce the risk of restenosis. This is according to findings from several studies presented at the 25th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium.


The increasing number of percutaneous coronary interventions (PCIs) being performed at low-volume centers without on-site cardiac surgery backup has driven the need for new safety and quality protocols. This is according to an expert consensus document written by a committee representing the Society for Cardiovascular Angiography and Interventions (SCAI), the American College of Cardiology Foundation (ACCF) and the American Heart Association (AHA). The document outlines steps hospitals can take to provide the safest possible environment for PCI when the facility does not provide cardiac surgery as a backup should complications occur.

Generating new cardiac muscle from human embryonic stem cells (hESCs) and/or induced pluripotent stem cells (iPSC) could fulfill the demand for therapeutic applications and drug testing. The production of a similar population of these cells remains a major limitation, but in a study just published in Stem Cells Translational Medicine, researchers now believe they have found a way to do this.

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