News from the Invasive Cardiology Community

Nurse Workload Tied to Surgery Patients’ Survival

The shortage of nurses that has plagued US hospitals for the past decade may be affecting patients’ survival after surgery, a study suggests. Dr. Linda H. Aiken from the University of Pennsylvania in Philadelphia and colleagues surveyed more than 10,000 staff nurses and reviewed medical data on more than 230,000 general, orthopedic and vascular surgery patients discharged from one of 168 Pennsylvania hospitals over nearly 2 years. The patient-to-nurse ratio ranged from less than 4:1 to more than 8:1.

Their findings reveal a troubling correlation between a higher patient-to-nurse ratio and an increased risk of patient death. Each additional patient per nurse was associated with a 7% increase in the risk of dying within 30 days of surgery, the report indicates.

At the same time, feelings of emotional exhaustion and job dissatisfaction ran high, particularly among nurses with the heaviest workloads. Nurses in hospitals with the highest number of patients per nurse were more than twice as likely to report burnout and were nearly twice as likely to report dissatisfaction with their jobs, compared with nurses with fewer patients to care for.

Many of these nurses said they wanted to leave their job within the year.

Too few nurses at the bedside compromises the nurse surveillance system for early identification and intervention to protect patients from the consequences of potentially life-threatening complications, Aiken said.

She said the findings come as no surprise to nurses, who have voiced concerns about unsafe staffing levels for years. Indeed, job demands and workloads for most nurses have led to job dissatisfaction rates four times higher than the average for all US workers, according to the report.

What this paper provides...is scientific evidence from a very large study validating nurses’ judgements that inadequate staffing adversely affects patients, Aiken said.

Improving staffing and reducing nurse turnover could ultimately lower hospital costs in addition to saving lives, the authors note.

The findings also support a California law that will go into effect next year mandating that one nurse can care for no more than six patients at once. Ultimately, nurses would have no more than five patients under their care.

On a national level, the Bush administration announced in September that it will send $8.4 million to US universities and health centers in an effort to help ease the nation's nursing shortage. The money will go to facilities in 20 states and the District of Columbia to improve nursing education and entice more minority applicants to enter the profession.

Health experts are particularly concerned that slow growth in the number of new nurses will fall behind the demand for nursing services as the baby boom generation ages, putting greater pressure on the nation’s healthcare system.

Camtronics Medical Systems Acquires VMI Medical

Industry leaders combine forces to provide advanced cardiovascular information management solutions

Camtronics Medical Systems, Ltd. has acquired VMI Medical, Inc., of Ottawa, Canada. Gene Bergholz, Camtronics President, stated, Camtronics' acquisition of VMI is evidence of our ongoing commitment and that of our parent company, Analogic, to continually reinforce our position of leadership in cardiovascular information management applications. Integrating VMI's industry-leading family of pediatric products with our VERICIS® for Cardiology Image and Information Management system enables us to offer our customers a broader range of advanced solutions for both pediatric and adult cardiology departments.

VMI Medical's President, Doug Seaborn, noted, This important step forward provides VMI with substantial financial and technological resources to further strengthen our clinically superior cardiac imaging and information management technology. We will not only continue to support our installed EchoVACS systems, we will continue to enhance VMI's peerless, next-generation Echo IMS. Seaborn added, Camtronics has already been working with VMI for some time to provide our clinicians with an unprecedented data analysis and patient tracking solution to meet the highly specialized needs of children's heart centers.

VMI Medical, Inc., now a subsidiary of Camtronics, remains based in Ottawa, Canada and will continue to support its current customers.

API, ASCP, and JCAHO Announce Collaborative Relationship To Offer
New Laboratory Accreditation Product

The American Proficiency Institute (API), the American Society for Clinical Pathology (ASCP) and the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) announce a collaborative relationship to offer, as an option, a combined package of laboratory accreditation services, customized proficiency testing and technological and scientific educational services. Laboratories will be able to integrate menu-driven, web-based API proficiency testing that meets JCAHO accreditation requirements and participate in ASCP technological and scientific educational programs. Through this collaborative effort, the expertise of pathologists, medical technologist surveyors and an experienced proficiency testing provider will be integrated into the JCAHO survey process.

Such collaboration would meet the needs of laboratories by offering reduced costs, improved service, new educational opportunities and enhanced surveyor expertise in a one-stop, coordinated fashion.

With this new accreditation program, laboratory professionals are able to customize and pay for only the proficiency testing services they need, says Daniel Edson, president, API. "They could then report and access the proficiency testing results from a secure website when it is convenient for them.”

Laboratories would also be enrolled in a portfolio of technological and scientific education programs that are tailored to the relevant needs of accredited laboratories, says E. Eugene Baillie, MD, FASCP, president, ASCP.

It is our hope that in the future, JCAHO surveyors could review the API proficiency testing results prior to survey, instead of searching for them on-site, says Joanne Born, executive director, Laboratory Program, JCAHO. This enhancement would save time and enable more on-site discussion and education.

Demographics to Take Long-Term Toll on U.S. Hospitals: Expect Hefty Increase In Demand for Beds and Services

The demand for beds in U.S. hospitals is projected to increase by as much as 46 percent in the next 25 years, according to a new study by Solucient. This increase of an additional 238,000 beds is expected to result from long-term demographic shifts in the U.S. population, which could drive up demand for inpatient acute care through 2027.

The new long-term forecasts also show that total acute care admissions are projected to increase by 13 million cases during that same time frame a 41 percent increase from the current number of national admissions.

Such forecasts come at a time when many acute care hospitals nationwide are experiencing increases in hospitalizations, resulting in capacity constraints, and an unprecedented boom in hospital construction and expansion projects.

Several demographic factors are likely to contribute to the 25-year growth in inpatient care, including the aging of the baby boom generation, increasing life expectancy, rising fertility rates, and continued immigration. These factors, however, will not affect each market equally.

Regionally, inpatient demand will grow fastest in the Western and Southern states and more slowly in Midwestern and Northeastern regions. However, even in slower-growing communities, the aging population will prompt a hospitalization growth rate that will outpace growth of the total population. For example, while the total Chicago population is expected to grow by only 13 percent in the next 25 years, the large number of aging baby boomers retiring in that market will spark a 30 percent increase in inpatient bed demand more than twice the population growth rate.

This analysis quantified the potential impact of demographic changes by applying demographic projections to population-based and age-specific hospital utilization rates built from Solucient’s hospital data warehouse. The study assumes no change in use rates for both admissions and patient days over the time period. Bed demand is calculated on an assumed 80 percent bed occupancy rate.

For a copy of the analysis, National and Local Impact of Long-term Demographic Change on Inpatient Acute Care, or to order local information for a specific market, visit the Publications and Reports section of the Solucient web site at www.solucient.com [4].

Corvas Initiates Phase II Clinical Program for its Novel Anticoagulant rNAPc2 in Patients with Acute Coronary Syndromes

Corvas International, Inc. commenced a multi-center, Phase II clinical program to investigate the safety and efficacy of its proprietary anticoagulant, recombinant nematode anticoagulant protein c2 (rNAPc2) in patients with acute coronary syndromes (ACS), including unstable angina and non-ST-segment elevation myocardial infarction (UA/NSTEMI).

The objective of the clinical program, referred to as ANTHEM/TIMI 32 (Anticoagulation with NAPc2 To Help Eliminate MACE (Major Adverse Cardiac Events)/TIMI 32), is to evaluate a safe and effective dose of rNAPc2 in moderate to high-risk patients with UA/NSTEMI. The program will be conducted in three parts. Each will investigate rNAPc2 in combination with current anticoagulant and antiplatelet therapies using the low molecular weight heparin (LMWH) enoxaparin and aspirin, respectively. The use of the antiplatelet agents clopidogrel and platelet glycoprotein IIb/IIIa antagonists will also be included.

The first part of the program will evaluate a safe dose range of rNAPc2. It will be administered as an intravenous bolus injection in a double-blind, placebo-controlled dose escalation trial in 125 UA/NSTEMI patients who are likely to undergo cardiac catheterization leading to percutaneous coronary intervention (PCI). The primary outcome measurement will be significant bleeding using contemporary criteria. Secondary efficacy endpoints will include recurrent myocardial ischemia using continuous electrocardiographic monitoring over 7 days using portable Holter devices. The trial will be conducted in 15 clinical centers in the United States.

The second and third parts of the program will focus on dose confirmation, with the primary objectives of evaluating clinical efficacy and safety. Studies will be double-blind and placebo-controlled, and include patients undergoing either early PCI or primary medical treatment. The ANTHEM/TIMI 32 Phase II clinical program may enroll up to 1,600 patients in 120 clinical centers in North America and Europe.

rNAPc2 is a small protein that was originally isolated from blood-feeding hookworms and is currently manufactured as a recombinant protein for clinical use. The mechanism of rNAPc2 involves inhibition of the protease complex Factor VIIa/Tissue Factor, which is responsible for the initiation of the process leading to blood clot formation. Currently, rNAPc2 has been shown to be safe and well-tolerated in close to 500 patients and volunteers studied to date, which includes a Phase II study in 293 patients undergoing total knee replacement where rNAPc2 was shown to safely reduce the incidence of deep vein thrombosis (DVT) by over 50% compared to a contemporary historical control with the low molecular weight heparin enoxaparin. A second Phase IIa study demonstrated that rNAPc2 could be safely added to standard therapy with unfractionated heparin, aspirin and clopidogrel in 150 patients undergoing elective PCI. This study also demonstrated that rNAPc2 suppresses the formation of thrombin for at least 36 hours following a single administration, compared to standard therapy alone, in which thrombin generation continued unabated.

TransVascular, Inc. Reports First Successful Clinical Application Of the CrossPoint TransAccess Catheter

TransVascular, Inc., has announced that its CrossPoint® TransAccess® catheter was utilized clinically for the first time in the United States on October 4, 2002 at El Camino Hospital in Mountain View, California. The CrossPoint catheter is a dual lumen catheter designed to facilitate the placement and positioning of catheters within the peripheral vasculature. The CrossPoint TransAccess catheter incorporates JOMED’s IVUS imaging technology for integrated visualization during the procedure.

The product performed exactly as intended, allowing the successful completion of a peripheral procedure that would have been difficult, if not impossible, to complete otherwise, stated Dr. Jim Joye of El Camino Hospital, The CrossPoint will allow interventional cardiologists and radiologists to successfully complete a higher percentage of their peripheral cases thereby reducing the frequency of patients being referred to surgery.

TransVascular will be gradually expanding the number of centers utilizing the CrossPoint TransAccess Catheter over the next six months, as manufacturing capacity increases to meet the expected demand for the product.

Diet, Exercise Said to Help Heart in Three Weeks

As little as three weeks of eating healthily and exercising can significantly lower a man's risk of heart disease by reducing blood pressure and cholesterol.

Eleven obese men who signed up for three weeks of eating a low-fat, high-fiber diet rich in fruits and vegetables lost a little weight but, more importantly, lowered blood pressure. The men also took a brisk daily walk.

This is the first study to show that this type of diet and exercise can reduce oxidative stress, lower blood pressure, and improve risk factors for other chronic diseases in a very short time, R. James Barnard, a professor of physiological science at the University of California Los Angeles who led the study.

During the three weeks, the men got fewer than 10 percent of calories from fat, 15 to 20 percent from protein and 70 to 75 percent from whole grains, fruit and vegetables. They could eat all the whole-meal bread, pasta, fruit and vegetables they wanted. They also walked on a treadmill for 45 to 60 minutes a day.

Barnard's team tested the men's blood for cholesterol, glucose and insulin measurements, all associated with heart disease, at the start and end of the program. They measured blood pressure, nitric oxide availability and looked for the presence of charged particles called free radicals that can damage blood vessels and cause heart disease.

Nitric oxide helps to relax blood vessels, reducing blood pressure, and higher levels can help prevent clogged arteries.

After just three weeks, the seven men who started out with high blood pressure had normal blood pressure.

Overall, the men reduced their cholesterol by an average of 19 percent, blood pressure by 14 percent and free radicals by 28 percent. Insulin levels plunged 46 percent and glucose fell 7 percent.

Medical Educational Facility Broadcasts in Live, High-Definition Format at Emory’s Carlyle Fraser Heart Center

In an area where only the entertainment and sports industries have experimented, today, medical education takes a front seat as physicians at Emory's Carlyle Fraser Heart Center transmit live, high-definition images from the operating room to health care professionals across the country.

Our new technology is like nothing the medical community has ever experienced and allows for enhanced medical education, says Angel Leon, MD, chief of cardiology, Emory Crawford Long Hospital. The high-definition quality provides images that are clearer, sharper and more vibrant than the current standard.

The Heart Center has remote-controlled, high-definition cameras mounted in cardiac surgery operating rooms and catheterization and electrophysiology laboratories. In addition, live, diagnostic images from physiologic monitors, fluoroscopy, positive emission tomography, echocardiography and nuclear cardiology can be viewed in high-definition format during invasive procedures.

The Heart Center's conference room has dual screens that enable an audience of 35 to learn by comparing simultaneous images of both inside and outside the patient's body. Or, in the case of a remote audience, images can be transmitted live via satellite to anywhere in the world.

Two-way audio communication allows physicians in the Heart Center's procedure rooms to interact with colleagues, health professionals and students around the world.

Scion Cardio-Vascular Announces CE Marking for Sci-Pro® Filter Protection Device

Advanced Guidewire-Based Filter Approved for Sale in Europe

Scion Cardio-Vascular, Inc. has received CE Marking for its Sci-Pro® filter protection device. The Sci-Pro is a guidewire-based filter and retrieval system designed to provide protection during interventional surgical procedures such as peripheral circulatory percutaneous transluminal angioplasty (PTA) and stenting. The device is as simple to use as an ordinary guidewire and is designed to provide distal protection, while serving as an embolic material retriever. The product uses a proprietary push/pull system to open and close a nitinol basket and requires no delivery sheath, which in turn allows an extremely low crossing profile.

Scion Cardio-Vascular has completed an extensive animal trial on the Sci-Pro Distal Protection Device with Steven R. Bailey, MD, Director of Interventional Cardiology at the University of Texas Health Science Center San Antonio. The device was extremely easy to use and tracked very well in tortuous vessels, said Dr. Bailey. The Sci-Pro has a low crossing profile and controllable deployment, even with angioplasty balloons loaded on the device.

Federal Court Overturns FDA Pediatric Rule

A federal district court has overturned the US FDA Pediatric Rule. The court found the rule goes beyond the agency's statutory power. The Competitive Enterprise Institute, the Association of American Physicians & Surgeons, and Consumer Alert had filed suit against the rule in December 2000.

Under the Pediatric Rule, which FDA issued in 1998, the agency can demand that drug manufacturers perform testing on off-label pediatric uses. Even though a drug may be labeled for use by adults only, it would have to be tested on children if there was a likelihood pediatricians would use it. The agency claimed it was acting to protect children, but CEI and the other plaintiffs argued the result would be a more burdensome approval process with fewer new drugs overall.

In our view, the Pediatric Rule constituted a drastic change in the drug approval process, said Sam Kazman, CEI's general counsel. The FDA essentially claimed it could force new uses, or new patient populations in this case, children on a label. While the rule was limited to pediatric uses, it opened the door for testing requirements for other off-label special patient populations and for other off-label uses. The end result could be a far riskier and costly approval process, and ultimately, fewer drugs.

In yesterday’s ruling, the judge reached the merits of the issue. It found that FDA’s approach was unauthorized under the Food, Drug and Cosmetic Act, and was contrary to the voluntary, incentive-based approach that Congress has taken to encourage off-label pediatric testing.

SimSuite Center Opens at the Swedish Heart Institute

Without Putting Patients at Risk, the SimSuite Training System Provides Healthcare Teams With Safe Options for Learning New Procedures and Sharpening Skills

The world's first commercial SimSuite Center has opened in the Swedish Heart Institute in Seattle. Developed by Medical Simulation Corp. (MSC) of Englewood, Colo., the high-tech simulated training system is poised to revolutionize how physicians and healthcare teams learn, and to benefit patient outcomes and quality of care.

Enabled with a simulated patient named Simantha the SimSuite Training System simulates the realistic experience of a patient with routine or unique needs being received and treated by hospital staff. The system integrates a patented, tactile force-feel technology in a dynamic learning environment.

Now doctors can hone their skills on a system that looks, sounds and feels as close to reality as possible, says Dr. Mark Reisman, director for cardiovascular research and interventional cardiology at the Swedish Heart Institute. When we treat real patients, that will mean faster completion times and fewer complications.

At Swedish Heart Institute, the SimSuite Center will be used to train physicians, nurses and techs on catheter-based, cardiovascular procedures such as angioplasty, as well as the placement of cardiac stents. Hundreds of these procedures are done every day in hospital cardiac catheterization labs across the U.S.

As the Northwest's largest, most comprehensive source for advanced cardiac care, the Swedish Heart Institute trains providers from around the world. We're excited to begin offering them an opportunity to learn and practice new techniques and to trial new devices in a virtual setting, says Jay Bohreer, executive director of the Swedish Heart Institute. This type of reality-based training and the availability of this technology is great news for patients everywhere.

Simulation technology has been used for decades in the aviation industry to train pilots on new aircraft. It is now federally mandated, says Captain Bill Rutherford, MD, retired vice president of flight standards and training for United Airlines, and partner in HRR Consultants, a firm specializing in the medical application of human factors and simulation. We know it works and are pleased to see this sophisticated technology transferred to medicine.

Lenox Hill Hospital Successfully Completes Robotic Assisted Epicardial Microwave Ablation

Didier Loulmet, MD, Chief of the Minimally Invasive Robotic Cardiac Surgery Program at Lenox Hill Hospital and William Frumkin, MD successfully performed the world’s first robotic assisted epicardial microwave ablation on a 45-year-old male suffering from chronic atrial fibrillation.

Using the Da Vinci Surgical System, Dr. Loulmet performed this robotic-assisted surgery without a chest incision. Only four pencil sized holes were made between the ribs. Through these holes, two robotic instruments and an endoscope gain access to the heart, making surgery possible without opening the chest. The small incisions cause less pain and scarring and a quicker recovery time for the patient than traditional open-heart operations.

Microwave ablation is performed using a special flexible probe to direct microwave energy and create several lesions on the heart. The lesions block the conduction of abnormal electrical beats and restore a normal heartbeat.

This is an exciting time in cardiovascular surgery. Successfully completing epicardial microwave ablation with only four key hole incisions is truly a remarkable breakthrough in minimally invasive procedures, said Dr. Loulmet, who was the first surgeon to use robots in cardiac surgery and performed the world’s first totally endoscopic closed-chest coronary bypass surgery using robotics in France in June 1998.

This procedure gives people a non-invasive surgical option for the treatment of chronic atrial fibrillation which affects 2 million Americans, added Dr. Loulmet. After a period of recovery following the procedure, most patients can stop taking blood thinners.

Survey of American Workers: I'm Obese, a Smoker, and Never Exercise And I'm the Picture of Health

Nearly one in five American workers is grossly obese, smokes, drinks heavily and never exercises, yet believes he or she is in excellent health, according to a new national survey released today by Oxford Health Plans, Inc.

The Oxford study of 1,450 employed adults found that nearly one in five American workers has a perilously skewed view of his/her behavior and the health risks it poses. While proclaiming their health to be excellent (rated 9 or 10 on a 1-10 scale), those workers tend to be at least 25 pounds overweight (55 percent), smoke (31 percent), each day drink three or more glasses of alcohol (21 percent), and four or more cups of coffee or tea (29 percent) and never exercise (36 percent). In addition, they are the least likely workers to eat a balanced breakfast (25 percent) but are among the most likely to eat fried foods (24 percent) and salty/sugary snacks (26 percent).

At the same time, those employees who actually maintain healthy lifestyle habits such as frequent exercise and good diet endure the least amount of workplace stress and are the most motivated at work (8.9 on a 10-point scale) and most useful on the job (9 on a 10-point scale), the Oxford survey showed. They are the least likely to lose sleep over their jobs (10 percent) and least likely to miss personal or family activities due to work (13 percent).

The Oxford survey findings come in the wake of U.S. Surgeon General’s declaration that obesity has become an epidemic that is about to surpass smoking as the leading cause of preventable death in America. Obesity is also catching up to smoking in terms of health care and productivity costs. Obesity now costs the U.S. healthcare system $61 billion in excess expenditures and U.S. industry $56 billion in lost productivity each year compared with smoking costs of $75 billion in medical bills and $82 billion in reduced productivity, according to the Surgeon General. Meanwhile, Congress this year introduced the Obesity Prevention and Treatment Act to improve American's eating habits amid reports that both traditional restaurants and fast food chains are shattering records for meal portion size and calorie levels.

The workers with the most bad habits who think they are the healthiest say they sit at their desks the whole day (37 percent), take no breaks once they get to work (41 percent), and are most likely to lose sleep over work (18 percent). They are most likely to feel that they are considered workaholics (28 percent). Tips for staying healthy in the American workplace can be found at http://www.oxfordhealth.com/ [5]. Central Marketing Inc., of New York City, conducted the random telephone survey. The margin of error is plus or minus three percent.

Colleagues Pointed Finger at Heart Doctors

Suspicious colleagues put the spotlight on two cardiologists at a California Hospital owned by Tenet Healthcare who allegedly performed hundreds of unnecessary invasive heart procedures, according to an affidavit filed by the FBI.

The affidavit relied heavily on information provided by other doctors in the Redding, California area, who called into question the legitimacy and volume of heart procedures performed by Dr. Chae Hyun Moon, director of cardiology at the Redding Medical Center, and Fidel Realyvasquez, the hospital’s chairman of cardiac surgery. The federal affidavit portrayed the hospital as a place where the two doctors routinely convinced, or allowed, healthy patients to undergo invasive heart procedures, thereby elevating the stature and profit of the doctors and hospital.

Forty federal agents raided the hospital and its medical archives in search of evidence, but so far no charges have been filed in the case. In the affidavit, a medical colleague asserts that Dr. Moon boasted five years ago of having already steered $40 million worth of billings to Tenet-owned Redding Medical Center. FBI agent Michael Skeen, in his affidavit, said colleagues observed that Moon stuck to a maniacal pace during the last four or five years to perform thousands of heart procedures.

The document asserts that Moon also faithfully steered legions of healthy patients to Realyvasquez and that together the doctors helped build the 238-bed hospital’s reputation into that of a major heart facility, even though up to half its heart surgeries might have been unnecessary.

One colleague quoted in the affidavit said Moon and the hospital’s cardiac program had been above-board in 1987, but that changed in the early 1990s when the hospital began positioning itself as a top-ranked heart center.

From that point on (the colleague) felt that Moon and the cardiology program ... were much too aggressive in their diagnosis and treatment of patients, the affidavit said. The affidavit said the same suspicious colleague warned the former chief executive of the hospital in 1998 or 1999, and current chief executive Hal Chilton in the summer of 2001, that unnecessary heart procedures were being performed. But he said there was no indication any corrective action was taken.

Neither Chilton, Moon nor Realyvasquez could be reached for comment. But Realyvasquez’ attorney, Malcolm Segal, said it was absolute nonsense to allege the surgeon performed operations on healthy patients.

My client enjoys one of the best reputations among heart surgeons in Northern California. He does what every other doctor does in using all available diagnostic tools and making the determination whether to recommend surgery.

Tenet spokesman Gary Hopkins stressed that Tenet is not a target of the Justice Department probe into alleged Medicare fraud. He answered categorically no, when asked if the two doctors had been encouraged by the hospital to perform large numbers of procedures in order to produce billings for the hospital.

Tenet planned to retain an independent cardiologist or two to review the patient medical records brought into question by the probe.