Let's say you're diagnosed with a cardiac arrhythmia for which implantation of an ICD – implantable cardioverter defibrillator – is indicated as a protection against sudden cardiac death. You're in good company, with some 300,000 persons in the U.S. alone newly diagnosed each year as potential candidates for ICD therapy. Now, get this: Only 60,000 of you will receive an implant of an ICD this year.

"So, in the most highly developed country in the world, only one person in five among those who need it will receive this important therapy," said Fred McCoy, who heads up Guidant's (Indianapolis, Indiana) cardiac rhythm management business, located in St. Paul, Minnesota.

But neither McCoy nor his competitors, Steve Mahle of Medtronic (Minneapolis, Minnesota) and Dan Starks of St. Jude Medical (also St. Paul), had a firm answer for why that situation exists.

The three industry executives took part in a panel discussion during the annual meeting of the North American Society of Pacing and Electrophysiology (NASPE; Natick, Massachusetts) in May on "Addressing Workforce Needs in EP and Pacing."

McCoy called the 1-in-5 ratio "a sobering statistic," especially when one considers that this isn't some new, relatively untried therapy that we're talking about. "To have these kinds of numbers after 15 years [of doing implantable therapies] we're clearly underserving this patient population today," he said.

And, if current clinical trials such as MADIT II report positive reports, that will greatly broaden both the indications and potential patient populations for ICD therapy by another 200,000 persons a year in the U.S. McCoy and company don't even want to consider the dismal implications of a recalculated ratio.

For McCoy, both the existing and potentially expanded numbers are "a call to action." Starks, who, until a promotion to president and chief operating officer of St. Jude Medical earlier this year, headed that company's cardiac rhythm management business, said one reason growth in ICD procedure volume may be stalled is a matter of how electrophysiologists spend their time. ICD procedures rank a relatively distant third to catheter ablations and pacemaker work.

Echoing statements made by him and other company officials St. Jude's annual meeting with market analysts just prior to the NASPE gathering, Starks said the answer to what's next for EP labs is atrial fibrillation (AF) – a pool of 2.2 million to 3 million additional patients, including more than 220,000 new patients a year. "As we develop the tools [new ICDs], we need to add these numbers," Starks said.

Mahle, president of industry giant Medtronic's CRM business, noted, "There are an enormous number of people who could benefit from the therapies we offer ... but if I were a patient with one of these illnesses, the future is not very bright" because of access issues.

Mark Schoenfeld, MD, of Yale University Medical School (New Haven, Connecticut), gave a nod to his fellow panelists, saying that companies in the sector "deserve kudos for observing what may be a crisis in manpower" on the clinical side.

Earlier NASPE efforts to quantify the staffing question showed that "there clearly were some maldistribution problems," Schoenfeld said, with many urban centers such as New York and Philadelphia almost overrun with electrophysiologists while other regions going a-wanting. "Thankfully," he said, "NASPE is again looking at this question."

Dwight Reynolds, MD, of Oklahoma City, Oklahoma, who is chairing the NASPE manpower survey effort, said the gathering of information will be completed within three to four months, with analysis of the data likely to carry the reporting of findings out past year's end.

The question isn't just one of whether the estimated 1,200 (one company believes the number to be closer to 1,800) electrophysiologists is enough – nor even one of "maldistribution." One EP unit administrator from the Midwest said, "There's a great need for more manpower in the EP lab, period." That led to later discussions about how industry – led to a considerable degree by the companies represented on the panel – recruit some of the best and brightest from EP staffs for their own programs, including monitoring of clinical trials.

One luncheon attendee, who described herself as a former EP nurse for panel moderator David Cannom, MD, of Los Angeles, said she now "works for Fred [McCoy]." She said the change was "not so much for the money as for the challenge and the opportunity to be involved with something new," while at the same time avoiding the financial potholes afflicting hospitals in the managed care age.

In discussing the EP manpower question, McCoy said Guidant's perspective is that there is "opportunity for growth" in ICD volume within the existing number of EPs, given changes in time management. However, he noted, "We clearly need to change the number of electrophysiologists in order to handle the explosion [in number of applicable cases] that is coming."

AHA: Diabetics don't understand risk

According to the American Heart Association (AHA; Dallas, Texas), heart disease is the leading complication and cause of death among diabetes patients, yet many of them do not understand the risk or its cause. Results of a recent study released by the association, 63% of diabetes patients experience cardiovascular disease, yet only 33% consider heart conditions to be among the "most serious" diabetes-related complications.

Adults with diabetes are two to four times more likely to have heart disease or suffer a stroke than adults without diabetes, the study showed. A key contributor to this increased risk, and a powerful predictor of Type 2 diabetes, is the presence of insulin resistance, a condition where the body cannot use the insulin it produces effectively. Insulin resistance is associated with blood lipid imbalances, such as an increased ratio of small low-density lipoprotein (LDL or "bad" cholesterol), low levels of high-density lipoprotein (HDL or "good" cholesterol), and increased levels of triglycerides, which cause atherosclerosis.

"Research from the past few years has helped us to better understand the link between diabetes and cardiovascular disease, and the role insulin resistance plays in both," said Sidney Smith, MD, chief science officer for the AHA. "The American Heart Association considers diabetes one of the other major risk factors for cardiovascular disease. Unfortunately, diabetes patients still tend to treat heart disease as a separate concern."

Additionally, the survey found that only 53% of patients ate the recommended number of fruits and vegetables and only one-third reported exercising on a regular basis, with many patients not monitoring their body weight regularly. "Exercising, maintaining a healthy diet and controlling body weight can help prevent and control not just cardiovascular disease but diabetes as well," Smith said. The survey was conducted by Roper/Starch Worldwide in December 2000 for Partners Against Insulin Resistance (PAIR). PAIR, an educational program underwritten by Takeda Pharmaceuticals North America (Lincolnshire, Illinois) and Eli Lilly and Co. (Indianapolis, Indiana), is an initiative led by a multi-disciplinary group of health care experts whose goal is to further the understanding of insulin resistance and its role in diabetes and related complications. The survey of 532 people with Type 2 diabetes revealed that only about half (52%) of respondents were familiar with the term "insulin resistance." Of the patients polled, 57% were aware that insulin resistance is associated with heart disease. "There is a great disconnect between perception and reality when it comes to understanding diabetes and insulin resistance and their related complications," Smith added.

"The good news is, insulin resistance is treatable. The bad news is, few patients know about it. The goal is to increase awareness by reaching out to patients, their families and the medical community," said David Kendall, MD, co-chair of the PAIR advisory panel and medical director of the International Diabetes Center at Park Nicollet Medical Center (Minneapolis, Minnesota).

Study shows t-PA clears catheters

Of the 5 million catheters inserted each year in the U.S., around 60% become blocked by blood clots. Those blot clots obstruct the pathway to life-sustaining treatment such as chemotherapy, antibiotics or nutritional fluids. Now, according to the results of a recent study, a drug used for heart attacks could safely be used to clear blocked central venous catheters.

The study was led by Steven Deitcher, MD, director of clinical thrombosis and vascular research in the section of vascular medicine in the department of cardiovascular medicine at the Cleveland Clinic (Cleveland, Ohio). Results of Deitcher's COOL-2 study were presented last month at the annual meeting of the Society for Vascular Surgery in Baltimore, Maryland.

COOL-2, which stands for Cardiovascular thrombolytic to Open Occluded Lines, evaluated the use of recombinant tissue plasminogen activator (t-PA) as a means to clear occluded central venous catheters. Deitcher and his team used a bio-engineered version of recombinant t-PA from Genentech (South San Francisco, California), known as alteplase, which dissolves blood clots by triggering the body's own mechanisms. Currently, there is no drug approved by the FDA to remove blood clots from blocked catheters.

"Coping with occluded, or blocked, catheters is an ongoing challenge for caregivers," Deitcher said. "The blockages can prevent appropriate treatment, and the blockages often can mean a patient must undergo surgery to have the blocked catheter replaced. The COOL-2 study demonstrated that a regimen of up to two 2-mg does of recombinant t-PA is a safe, effective way to restore flow to occluded central venous catheters."

The open-label, single-arm multicenter study involved a total of 995 people ranging in age from 2 to 91 who had occluded central venous catheters. All patients enrolled in the study received a 2-mg dose of recombinant t-PA that was allowed to stay in the affected catheter for 30 to 120 minutes. Those patients whose catheters still were blocked at 120 minutes received a second 2-mg t-PA dose that also was allowed to stay in the catheter for between 30 and 120 minutes.

"None of the patients had intracranial hemorrhage, major bleeding or embolism as a result of this treatment," Deitcher said. "Fifty-two percent of the catheters given one dose of recombinant t-PA had successful flow restored after 30 minutes; that rate of successful flow was increased to 78% after 120 minutes. After a second dose of recombinant t-PA was administered, successful flow was established in 84% and 87% at 30 and 120 minutes, respectively."

Clot-buster slows immune system reaction

The cutoff of blood flow to the brain is the cause of ischemic stroke. Right? Half right. A contributing cause is the immune system's overzealous response to the inflammatory brain damage it perceives as an insult to be remedied. White blood cells rush to the scene of the crime, but their fix-it efforts often aggravate the stroke patient's injury. But the body also secretes a countervailing molecule called activated protein C (APC), which exerts anticoagulant and anti-inflammatory effects. Its performance in a mouse model of stroke was reported in the April 3 issue of the journal Circulation.

"The damage from a stroke doesn't happen just because the brain is deprived of oxygen and other nutrients," said the article's senior author, neurosurgeon Berislav Zlokovic at the University of Rochester Medical Center (New York). "The influx of white blood cells into the brain causes tremendous damage. The role of inflammation in inflicting damage to the brain is only recently becoming appreciated."

The co-authors induced a stroke attack in mice by plugging their middle cerebral arteries (under anesthesia), thus interrupting blood flow for one hour, then reperfused the blood vessel. Fifteen minutes before or 10 minutes after the occlusion, they administered APC via intravenous injection. Animals that received APC were much more likely to survive their strokes than control counterparts, which did not get the drug. Eight of 12 control animals died within 24 hours.

The APC animals acquired a number of benefits: their brains had more blood flow and less swelling; their blood was less likely to clot; a smaller region of the brain was affected by the stroke; and their brains contained 90% fewer neutrophils than did control mice.

Eli Lilly & Co. is developing a genetically engineered version of APC, for use against sepsis, an often-fatal blood disorder. A study in the March 8 issue of the New England Journal of Medicine showed that APC reduced by 20% the rate of death in sepsis patients.

Endowed chairs at Baylor

Baylor University Medical Center (Dallas, Texas) has established two endowed chairs for cardiovascular research and an endowed chair for health care research and improvement. In addition, as part of a continued focus on medical education, Baylor will establish a training institute for robotics technology. The chairs and the Baylor Robotics Institute will be supported through a $22 million fund-raising campaign. The silent segment of the campaign has already raised $12 million.

"It is our intent to lead the nation in the treatment of cardiovascular disease," said Tim Parris, president of Baylor University Medical Center. The Cardiovascular Surgical Research Endowed Chair will support research to develop advanced cardiovascular surgical options for patients and will focus specifically on minimally invasive and "off pump" surgical procedures. The Dr. Paul Thomas Congestive Heart Failure Endowed Chair will support research related to treatment of congestive heart failure through an institutionally based congestive heart failure program with inpatient and outpatient components. The Thomas Congestive Heart Failure Chair primarily has been funded through the support of the Harry S. Moss Heart Trust.

An endowed chair for health care research and improvement will support processes to advance patient care and safety across Baylor Health Care System. The Baylor Robotics Institute, housed at Baylor Research Institute, will train physicians from around the country to use advanced robotics technology in cardiac and vascular, digestive, gynecologic and general surgeries. The robotics system translates the surgeon's hand movements made outside the body to precise micro-movements inside the body, using small, electronically enhanced, mechanical instruments. Baylor University Medical Center is one of just 10 hospitals in the U.S. participating in clinical trials using advanced robotics technology in cardiac surgery.

In another effort to expand cardiovascular services, Baylor will open the Baylor-Jack and Jane Hamilton Heart and Vascular Center in 2002. The specialty hospital has been designed specifically for inpatient and outpatient cardiovascular services.

Hospital procedures: 25% in cardiology

The Agency for Healthcare Research and Quality (AHRQ; Baltimore, Maryland) has just released new data related to cardiovascular procedures showing that one of every four hospital admissions – nearly 9 million per year – involve the use of a diagnostic imaging test, surgery, or some other procedure for heart and circulatory system problems.

Among those procedures, the four most common for adults are cardiac catheterization (3.9 million patients), bypass surgery 739,000 patients), echocardiograms (641,000 patients) and percutaneous transluminal coronary angioplasty (6708,000 patients). The new data comes from the 1997 HCUP Fact Book, No. 2, Procedures in U.S. Hospitals.