Cath Lab Digest

Action Products, Inc. Recognized in Imaging Study

In a newly published research poster, Action® OR overlays were found to successfully manage patient positional pain during interventional CT procedures lasting 45 minutes or longer, without impacting image quality. The poster abstract, titled, “Improving Patient Care by Managing Positional Pain During Interventional Computerized Tomography (CT) Procedures,” focused on non-pharmacological solutions for positional pain reported by patients during long procedures. Typical CT scans require patients to lie on a concave, hard surface designed for fast scanning versus patient comfort.

Action overlays were selected because they are radiolucent, low-maintenance, will not bottom out, and are recognized for positive pressure management, as cited in AORN best practices and standards 2008.

Christiana Care Health Systems is located in Newark, DE and is in the process of working toward magnet status. A copy of the poster is located on the Action Products website; visit www.actionproducts.com for more information.

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St. Jude Medical and GE Healthcare Announce Worldwide Market Launch of Wireless Integrated FFR Solution

St. Jude Medical, Inc. and GE Healthcare announced the worldwide commercial launch of the first fully integrated wireless solution for the measurement of fractional flow reserve (FFR).

The new FFR solution, seamlessly integrated into existing cath lab infrastructure, will enable physicians and cath lab staff immediate access to FFR measurement without time-consuming setup.

The solution is based on the PressureWire® Aeris technology and an FFR upgrade package available for the XT and XTi system configurations of GE’s Mac-Lab® hemodynamic recording system. PressureWire Aeris was developed and marketed by Radi Medical Systems, which was acquired in December 2008 by St. Jude Medical and is now part of the company’s cardiovascular division.

The Mac-Lab FFR upgrade utilizes existing cath lab infrastructure, including screens, input modules and controls, and together with the PressureWire Aeris technology forms a seamlessly integrated FFR measurement system for greatly improved cath lab workflow and ease of use.

“The PressureWire Aeris system represents a true paradigm shift in our thinking about the accessibility of FFR,” said Augusto Pichard, MD, professor of medicine, cardiology, and director of cardiac cath labs, Washington Hospital Center, Washington, D.C. “The integration with our existing GE hemodynamic recording system means that traditional limitations of FFR measurements, including utilizing a standalone machine for calculation, are removed.”

With all FFR results integrated into the existing physiological information archive, this new system documents the hemodynamic severity of coronary lesions, as measured by FFR, together with other procedural data and angiographic imagery, creating a more complete patient record.

The Mac-Lab FFR solution is available as an upgrade path to all existing GE Mac-Lab installations worldwide, as well as new installations.

Fractional flow reserve (FFR) is an index determining the functional severity of narrowings in the coronary vasculature and it is measured by PressureWire Aeris. FFR specifically identifies which individual coronary narrowing is responsible for ischemia.

The landmark trial FAME (Fractional flow reserve (FFR) vs. Angiography in Multivessel Evaluation), published in the Jan. 15 issue of the New England Journal of Medicine, demonstrated a statistically significant 30 percent difference in major adverse cardiac events (MACE) such as death, myocardial infarction and repeat revascularization. The randomized, prospective, multi-center trial looked at 1,005 patients with multi-vessel coronary artery disease 12 months after receiving a stent and compared outcomes for patients whose treatment was guided by FFR to those whose treatment was guided only by angiography.

The FAME study, in which pressure guidewires from Radi Medical Systems were exclusively used, also showed that FFR measurement is cost-saving and does not add time to the procedure.

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Healing Heart Attack Victims, One Cell at a Time

By using the amount of carbon 14 in the atmosphere from above-ground nuclear testing in the 1950s and 1960, researchers have determined that cells in the human heart develop into adulthood.

But as humans age, the percentage of new heart cells decreases markedly. By age 25, renewal of heart cells gradually decrease from 1 percent turning over annually to .45 percent by the age of 75. About 50 percent of the heart cells a human is born with will regenerate during a lifetime.

Myocardial damage often results in chronic heart failure because of the loss and insufficient regeneration of heart cells. But this new finding may mean that patients who have suffered myocardial damage as a result of a heart attack may have some good news.

Lawrence Livermore National Laboratory scientist Bruce Buchholz, with colleagues from the Karolinska Institute, Université Claude Bernard Lyon, Lund University and Lund University Hospital, found that cells in a human heart can develop into adulthood and the age of heart cells is, on average, six years younger than the individual.

Using the Laboratory’s Center for Accelerator Mass Spectrometry, Buchholz measured the amount of carbon 14 in DNA to establish the age of caridiomyocytes (cardiac muscle cells) in humans.

Carbon 14 atmospheric concentration levels remained relatively stable until the Cold War, when above-ground nuclear bomb tests caused a sharp increase, or peak, which decreased slowly after the end of above-ground testing in 1963. This spike in carbon 14 in the atmosphere serves as a chronometer of the past 55 years.

Because DNA is stable after a cell has gone through its last cell division, the concentration of carbon 14 in DNA serves as a date mark for when a cell was born and can be used to date cells in humans.

The team determined the ages of heart cells by determining the time at which the sample’s carbon 14 concentration corresponded to the atmospheric concentration. Buchholz found that people born around or after the nuclear bomb tests corresponded to atmospheric concentrations several years after the subjects’ birth, indicating substantial postnatal DNA syntheses.

“By analyzing individuals born at different times before 1955, it is possible to establish the age up to which DNA synthesis occurs, or whether it continues beyond that age,” Buchholz said.

In the study, carbon 14 concentrations were elevated in subjects compared to those people born up to 22 years before the beginning of nuclear bomb tests.

“DNA of myocardial cells is synthesized many years after birth, indicating that cells in the human heart do, in fact, renew into adulthood,” Buchholz said. “At the age of 50, 55 percent of the heart’s cells remain from the time around birth and 45 percent have been generated later.”

Cardiac muscles have a striated appearance and their contraction in the heart propels blood from the atria and ventricles to the blood vessels of the circulatory system.

The limited recovery in humans after a heart injury, such as a heart attack, demonstrates failing regeneration of heart cells. But the team concluded that the renewal of heart cells, as indicated by the mixing of carbon 14 in the DNA, suggest that the development of pharmacological strategies to stimulate this process may be a rational alternative or complement to cell transplantation strategies for heart cell replacement.

The research appears in the April 3 edition of the journal Science.

Founded in 1952, Lawrence Livermore National Laboratory has a mission to ensure national security and to apply science and technology to the important issues of our time. Lawrence Livermore National Laboratory is managed by Lawrence Livermore National Security, LLC, for the U.S. Department of Energy’s National Nuclear Security Administration.

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Invatec Announces Strategic U.S. Distribution Agreement with Cardiovascular Systems, Inc.

Invatec has entered into a strategic distribution agreement with Cardiovascular Systems, Inc., a medical device company focused on developing and commercializing interventional treatment systems for vascular disease. Under the terms of the agreement, CSI will distribute Invatec’s FDA-cleared percutaneous transluminal angioplasty (PTA) balloon catheter product line.

The CSI and Invatec sales forces will partner in selling the Amphirion Deep™ 0.014-inch PTA balloon catheter line, which is the first dedicated below-the-knee PTA catheter, as well as the Submarine Plus™ 0.018-inch PTA balloon catheter and the Admiral Xtreme™ 0.035-inch PTA balloon catheter lines. Invatec will continue to sell and market its other interventional products, such as its thrombus management catheter, the Diver CE™ and the FiberNet® embolic protection system.

Invatec and CSI share a vested interest in the market of peripheral intervention technology and both are developers of solutions that treat critical limb ischemia (CLI) and other peripheral procedures.

For more information, visit www.invatec.us.

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FDA Approves Abiomed’s New AB Portable Driver for Patient Transport, Mobility, Ambulation

Abiomed Inc. said the FDA cleared its AB Portable driver to facilitate intra-facility patient transport, patient mobility for participation in physical and rehabilitation therapies, independent ambulation by the patient, and inter-hospital transport via aircraft or ambulance.

The company said its new AB Portable driver offers a reliable cardiovascular support system, providing full bi-ventricular assist device (Bi-VAD) functionality. The new driver is designed to enhance the clinical utility of the Abiomed AB5000 Ventricle by increasing mobility and versatility without compromising performance.

The device is said to be a powerful, self-contained driver to assist the sickest patients, offering hemodynamic support directly from the operating room up through the weaning process without additional computers or docking stations, which are required with current portable consoles.

The AB Portable driver requires low-maintenance intervals of approximately every 5,000 hours or up to seven months of operation, which is estimated to be three times longer than existing portable consoles, the company said.

“Patients on full BiVAD support for heart recovery often require mobility and transport in order to provide a comprehensive assessment for a next stage of therapy,” said Mark Anderson, MD, department of cardiothoracic surgery, Robert Wood Johnson University Hospital. “The AB Portable driver is lightweight and compact and the quietest portable Bi-VAD console on the market, yet still provides that full level of Bi-VAD support from the minute you leave the surgery suite.”

The device has compact architecture that enables easy handling and transport. The driver is 25 percent smaller and 15 percent lighter than current portable consoles on the market, allowing easier independent patient ambulation, in-hospital transfer or land/air transportation, the company said.