CD&Ds

A middle-age man is at home one night and suddenly experiences chest pains, upper body pain, and shortness of breath. The symptoms point to one conclusion heart attack. Hopefully, an ambulance arrives and the man is taken in immediately to the emergency department (ED) of the nearest hospital, where he would be rushed into the care of attending ED physicians. Sounds somewhat cut and dried, doesn't it? But what if that same man had somewhat more ambiguous symptoms? What if he walked in under his own power to the ED and complained that he had some discomfort in the chest area or shortness of breath and wasn't sure what to do about it? Questions would be asked, tests ordered, and results analyzed. Then the waiting game begins for both doctor and patient.

A recent statistical analysis from the Centers for Disease Control and Prevention (Atlanta) concludes that the average time that hospital emergency room patients wait to see a doctor has grown from about 38 minutes to almost an hour over the past decade. Overall, about 119 million visits were made to U.S. emergency rooms in 2006, up from 90 million in 1996 a 32% increase. Meanwhile, the number of hospital emergency departments dropped to fewer than 4,600, from nearly 4,900, according to American Hospital Association (Washington) statistics.

This problem of increased ED length of stay is the focus of a recent study published in the Annals of Emergency Medicine. The study, "A Multicenter Randomized Controlled Trial Comparing Central Laboratory and Point-of-Care Cardiac Marker Testing Strategies," focuses on point-of-care (POC) testing as a way to reduce time to cardiac marker results in patients evaluated with acute coronary syndromes.

A lead author of the study, Richard Ryan, MD, of the University of Cincinnati School of Medicine, told Cardiovascular Devices & Drugs: "The majority of patients come in with vague chest pains; they're not having a heart attack nor need an EKG, so you need to order tests. That's where this POC device saves an incredible amount of time compared to the central labs. [The majority of time] is lost waiting for test results. With the POC test, it is done at the patient's side and the result is handed directly to the doctor."

This POC test he refers to is the i-STAT, made by Abbott Laboratories (Abbott Park, Illinois). The i-STAT resembles a television remote control in shape and size and features single-use disposable cartridges that can be used throughout the hospital to perform a menu of critical care tests, including cardiac markers, blood gases, chemistries and electrolytes, lactate, coagulation and hematology. The i-STAT menu includes prognostic, diagnostic and treatment indicators related to disease state management and clinical practice guidelines. Using just two or three drops of blood, the system can provide time-sensitive test results in minutes.

This device can allow for more patient satisfaction, and a more efficient use of ED physician's time. Ryan gives an example: "If I can get a low-risk chest pain patient that I know I have to get cardiac enzymes on, instead of waiting two to three hours to get the results from the lab, I can now get them in 15 minutes, then order another one, etc. Then I can send those patients home. That's a huge benefit. If you can get two or three patients out quicker that way, it saves about an hour's time. That also allows us to see more patients that day."

The study was conducted at multiple hospital sites, and the overall conclusions were mixed. At some sites the POC testing decreased time to admission, and at others, produced longer stays. But the general feeling with the authors is optimistic and more data gathering is needed. "There are many ways the research will move forward. One way is to capitalize on getting the cardiac marker test results back faster with looking at how to speed up other information the doctors need to make decisions, and how to change the flow of information to make it simpler," Christopher Lindsell, PhD, another author of the study, told CD&D.

The i-STAT complements the clinical lab's efforts by providing lab-quality results for the most critically needed tests while improving efficiency throughout the continuum of care. Abbott says that the i-STAT analyzer is currently in use in one out of every three U.S. hospitals (a total of 1,800) and more than 500 emergency departments.

ThromboVision seeks 510(k) for T-Guide test

A device that uses light-scattering technology to determine platelet aggregation in cardiac patients is making its way through the regulatory process. With its clinical trials of ThromboGuide (T-Guide) platelet aggregation system completed, ThromboVision (Houston), a diagnostics company, said in late July that it had filed a 510(k) application with FDA for clearance of the system.

The T-Guide consists of a disposable test kit and a point-of-care base unit. According to Thrombo-Vision, the system is designed to help physicians improve their cardiac patients' lives by providing additional information as they assess an individual patient's anti-platelet therapy used to prevent heart attacks, strokes and stent occlusions. "In layman's terms, it allows us to measure the level of stickiness of platelets," Edward Teitel, MD, president/CEO of ThromboVision, told CD&D.

Last October, the company was awarded $1.5 million from the Texas Emerging Technology Fund to foster commercialization of the T-Guide system, and in January it initiated clinical trials of the technology. Clinical trial data were gathered through independent studies at four research facilities: Methodist Hospital Research Institute (Houston), University of Arizona Medical Center (Tucson), Intermountain Medical Center (Salt Lake City); and Houston Institute for Clinical Research.

"With nearly 50 million patients on medications like aspirin and clopidogrel [Plavix] to modify the aggregability of their platelets, we are anxious to be able to offer our technology to doctors who treat patients for heart attacks, strokes, and stents occlusion prevention," Teitel said.

He said ThromboVision's 510(k) application is the culmination of research that began at the Utah Artificial Heart Institute (Salt Lake City), Brigham Young University (Provo, Utah), the University of Utah (Salt Lake City) and Thrombodyne (Salt Lake City) in 1998 and was then supported by multiple grants from the National Institutes of Health.

"After obtaining the worldwide, exclusive rights to the technology, ThromboVision did a great deal of design and engineering work to advance it to this point," Teitel said. "We are hopeful that when the FDA reviews our data and other materials, they will respond positively."

Teitel told CD&D that the company anticipates the test will be cleared and on the market later this year. "We're just excited to be able to bring a potential lifesaving technology to the market in a way that's cost-effective and simple to use," he said.

At least two other private device companies also are addressing the need for a simple point-of-care, CLIA-waived, rapid test for measuring platelet reactivity. Accumetrics (San Diego) introduced the first simple system for measuring individual response to multiple anti-platelet agents, including aspirin, Plavix, ReoPro and Integrilin. It has the only FDA-cleared, CLIA-waived, point-of-care test that measures whether a drug has blocked a specific pathway to platelet activation by using a specific cartridge for each drug tested.

Another company, Placor (Plymouth, Minnesota), is testing the platelet reactivity using shear force, mimicking a stenotic artery, rather than using a specific agonist that tests for a certain pathway of inactivation. The company's theory is that it is testing the actual ability of the platelet to aggregate, regardless of whether anti-platelet drugs are being used, eliminating the need to test for each drug prescribed to the patient. Placor's testing system requires only a fingerstick rather than a venipuncture, and the company expects FDA clearance and initial commercialization this quarter, followed by application for CLIA waiver. The test takes only 10 minutes.

CMS investigates warfarin sensitivity coverage

The Centers for Medicare & Medicaid Services said in early August that it would review its coverage status for pharmacogenomic testing of patients for sensitivity to the blood thinner warfarin. The issue of bleeding events has been on the agenda for FDA for some time, as indicated by the agency's revision of the label for the drug in August 2007, an action that may have helped prompt CMS's action.

Pharmacogenomic testing as a principle component of personalized medicine is seen as a harbinger of less costly and more effective healthcare, but the science behind such tests is not yet utterly clear. On one hand, a study conducted in 2006 by the Joint AEI/Brookings Center (Washington) suggested that bleeding events due to higher doses than needed cause 17,000 strokes and 85,000 bleeding events annually, costing the economy more than $1 billion each year.

However, clinical lab professionals recently indicated they are not necessarily of the opinion that such tests are ready for full deployment in clinical labs. All the same, industry seems ready to crank out reagents and analyzers for the test.

Michael Murphy, CEO of Paragon Dx (Morrisville, North Carolina), which makes reagents used in tests for warfarin sensitivity, told CD&D, "This is what everyone was waiting for," adding that CMS is obliged to "make a national decision so that there is uniform coverage for this test."

He acknowledged some uncertainty about whether the test should be used as a screening tool, remarking, "the question really is whether its cost effective to test everyone to catch the 15%" whose gene sets make they hypo- or hypersensitive to the drug. Murphy said he would estimate that less than 10% of Medicare eligibles who get warfarin are tested, and noted that some doctors feel that testing for prothrombin time is adequate to screen for warfarin sensitivity.

When asked whether Paragon can turn out the needed reagents should CMS give testing the nod, Murphy said, "It really would not be a problem for us. Our production is extremely scalable." He also said that Paragon is not the only firm waiting for the okay. "We're all patiently waiting for them to make that big decision," he said of the diagnostics industry, but cautioned that warfarin sensitivity testing as a screen is "not going to happen overnight." He also said, "There's a misconception that what we're trying to do is make genetic testing for warfarin the standard of care. That's not what we're trying to do. We're trying to augment the current standard of care, not replace it."

Top dollar from CMS for artificial heart

CMS recently gave the nod for coverage for the use of artificial hearts this past spring, but did not settle on the rate for reimbursement until more recently. In a July 31 statement, the agency reported that it will cover the use of artificial hearts through its two highest-paying codes.

The agency will use the Medicare Severity Diagnostic Related Groups (MS-DRGs) 001 and 002, which will command the approximate sums of $345,000 and $178,000 respectively. CMS said that this decision is effective retroactive to May 1. In the July 31 decision, CMS said that its coverage for the CardioWest total artificial heart "fulfills a role that no other mechanical circulatory support device can for patients in irreversible biventricular failure."

CMS also reported that it will pay a new-technology add-on for the CardioWest, made by SynCardia (Tucson, Arizona) beginning Oct. 1. In a statement, Rodger Ford, CEO/president of SynCardia, said, "In the past, hospitals and their patients have experienced great success with our device, but hospitals risked taking substantial economic losses in order to bridge these patients to transplant. Now, our certified centers can afford to save thousands of end stage heart failure patients."

The CardioWest, a device which is not fully implanted in the body, costs around $100,000.

Hand-held U/S for cardiologists

If you can't get the patient scheduled promptly for imaging tests, bring the tests to the bedside. That's the story behind the launch of a hand-held ultrasound system from Royal Philips Electronics (An-dover, Massachusetts), the Philips CX50 CompactXtreme, designed for cardiologists to use at the bedside. Philips says the compact system combines the image quality expected of a traditional, full-size system with the convenience of portability.

"Following extensive research into clinicians' needs, we've designed a laptop-sized system that can help them get to patients quickly no matter where they are in the hospital or clinic and which can produce high-quality images regardless of the difficulty of the situation at hand," said Anne LeGrand, senior VP and general manager, ultrasound, for Philips Healthcare.

"Clinicians told us that small, portable systems are beneficial, as long as the image quality can help them make a confident diagnosis. If poor image quality from a hand-held system results in inconclusive data, repeat exams may be needed at the cost of additional time and money. The CX50 was designed to consistently deliver high-quality images, even in technically challenging patients."

The CX50 CompactXtreme includes Philips' PureWave transducer, which the company says improves penetration in difficult-to-image patients and reduces clutter so clinicians can view fine structures in excellent detail.

It also features Philips' XRES adaptive image processing for reduced speckle and haze inherent with ultrasound imaging. As a result, images are virtually free from noise and have extraordinary clarity and edge definition, according to the company.

Thomas Buck, MD, associate professor of medicine, West German Heart Center, University of Essen (Gesamthochschule, Germany), said, "The combination of PureWave technology and XRES processing enables the system to deliver the same image quality as full-size systems, allowing full echo data analysis from a portable system without any compromises."

Abiomed acquires 21.6% stake in WorldHeart

Abiomed (Danvers, Massachusetts) last month reported closing a recapitalization agreement initiated in June to acquire a 21.6% stake in WorldHeart (Oakland, California). The transaction included subsidiary World Heart Inc. (WHI), Venrock Partners, Venrock Associates, Venrock Entrepreneurs Fund, Special Situations Fund III QP LP, Special Situations Cayman Fund, Special Situations Private Equity Fund, Special Situations Life Sciences Fund, Austin Marxe and New Leaf Ventures II. As a result of the transaction, Abiomed has acquired ownership of about 86 million common shares of WorldHeart.

The shares were acquired as a result of Abiomed's conversion of the full amount of principal and interest owed on the $5 million 8% secured convertible promissory note previously issued to Abiomed by WorldHeart and WHI, Abiomed's release of the security interest in all of the assets of WorldHeart and WHI that secured the note, termination of the warrant Abiomed held to purchase 3.4 million common shares of WorldHeart, and forgiveness of other amounts owed to Abiomed by WorldHeart.

Abiomed said it does not currently intend to acquire ownership of, or control over, additional securities of WorldHeart, which has experienced a string of financial difficulties. Earlier this year, the developer of mechanical circulatory support systems learned that its potential primary investor from an equity financing would not be able to meet its commitments. As a result, the company was not able to pay back a secured convertible promissory note in the amount of $5 million issued on Dec. 11, 2007, to Abiomed. Abiomed later agreed to convert the $5 million debt owed by WorldHeart to 86 million shares.

Lifepak is first AED in space

Physio-Control (Redmond, Washington) said that the Lifepak 1000 defibrillator has been deployed on the International Space Station (ISS) as the first automated external defibrillator (AED) in space. AEDs have become common in places such as airplanes, health clubs, and schools and now the Lifepak 1000 AED will be available for NASA crew members should someone experience sudden cardiac arrest in space.

The ISS has used manual defibrillators in the past, but Physio-Control said NASA decided to now deploy an AED because it requires less training and maintenance, better enabling astronauts to respond to a medical emergency. The small size and light weight of the Lifepak 1000 also helped minimize hardware mass and volume onboard the Space Station.

"We are honored NASA selected the Lifepak 1000 defibrillator to protect the lives of crew members onboard the International Space Station," said Brian Webster, president of Physio-Control, a subsidiary of Medtronic (Minneapolis). "The 1000 is used by thousands of emergency responders worldwide and was designed for use in the harshest environments and situations; it's proven to be one of the most reliable products Physio-Control has ever developed. This 'space first' is especially exciting for us, as it underscores the many reasons customers choose Lifepak defibrillators for emergency medical use."

$22.6M donation to University Hospitals

University Hospitals (Cleveland) reported in mid-August that it had received one of the largest financial gifts in its 143-year history a $22.6 million donation from well-known Northeast Ohio philanthropists, the Harrington and McLaughlin families. The donation, believed to be among the largest in the country given to a cardiovascular institute, is unique in that it is earmarked for the development of innovative technologies and clinical advancements for the early diagnosis and prevention of heart disease.

"This extraordinary gift from the Harrington and McLaughlin families will be invested in developing significant new breakthroughs in preventing and treating heart disease," said Thomas Zenty III, CEO of University Hospitals. "This gift will enhance our ability to continue to attract internationally and nationally known cardiovascular experts to Cleveland to join our renowned Heart & Vascular Institute. It is with great pride that we accept this gift and establish the University Hospitals Harrington-McLaughlin Heart & Vascular Institute. It truly represents our mission 'To Heal, To Teach and To Discover' which influences everything that we do."

The Harringtons were first introduced to University Hospitals through Dr. Carl Orringer, an expert in preventive cardiology. Dr. Orringer has developed an innovative screening program for assessing the risk of and preventing heart attack called the Early Detection Using Calcium Scoring for Treatment and Elimination of Coronary Heart Disease (EDUCATE).

EDUCATE utilizes CT imaging to check for the buildup of calcium in plaque on the walls of the coronary arteries. A portion of the families' gift will be used to honor Orringer and his extraordinary contributions to the field of cardiovascular medicine.