Infectious Diseases in Children, March 2008: 

Mortality and morbidity associated with pertussis dropped dramatically with the introduction of the pertussis vaccine in the United States during the 1940s. By 1994, coverage for three or more doses of pertussis-containing vaccines reached at least 90% among children aged 19 to 35 months.

Despite this success, however, the number of pertussis cases in infants aged 3 months or younger that were reported to the national passive surveillance system increased between the 1980s and 1990s.

To examine the situation from 1993-2004, Margaret M. Cortese, MD, and colleagues conducted a study that compared results obtained from the national passive surveillance survey with the rates of infant pertussis hospitalizations obtained from databases that did not rely on passive reporting.

Their results were published in Pediatrics this month.

Pertussis hospitalization rates

The researchers compiled annual incidence rates for pertussis hospitalizations from the national Supplemental Pertussis Surveillance System and two hospital discharge databases: the Nationwide Inpatient Sample and the Kids’ Inpatient Database.

Data were included for infants aged between 0 and 11 months who were hospitalized for pertussis between 1993 and 2004.

According to the researchers, infants aged between 1 and 2 months had the highest incidence of pertussis hospitalizations based on data collected from the national Supplemental Pertussis Surveillance System.

Hospitalization rates taken from the Nationwide Inpatient Sample were generally stable for infants aged 2 months or younger between 1993 and 2004 and appeared to decrease among infants aged between 3 and 11 months. The peak rates for infants aged 1 to 2 months occurred in 1993 (305 hospitalizations per 100,000 live births), 1999 (259 per 100,000 live births) and 2004 (292 per 100,000 live births).

Cortese and colleagues reported that their findings were similar or slightly higher for the Kids’ Inpatient database.

“Approximately 2,700 infants aged younger than 1 year were hospitalized with pertussis in 2003. Of these hospitalizations, 86% occurred in infants aged 3 months or younger,” Cortese, medical epidemiologist at the CDC’s National Center for Immunization and Respiratory Diseases, told Infectious Diseases in Children. “Ninety-five percent of infants who required mechanical ventilation and all who died were aged 3 months or younger.”

Hospitalization rates were highest among infants aged 1 month, which is younger than the age that the tetanus-diphtheria-pertussis vaccine is typically recommended.

Methods for improvement

The researchers emphasized that infants should receive their first dose of TDaP as soon as they reach the recommended age and should complete the series on time.

Advisory Committee on Immunization Practices’ recommendations for close contacts of infants and all adolescents and adults aged 65 years and younger to receive TDaP are also important because adherence may help reduce the circulation of Bordetella pertussis, according to Cortese.

“In addition to strategies to reduce infant exposure to B. pertussis, other strategies that should be fully evaluated are passively protecting infants by vaccinating pregnant women and actively immunizing infants early, even before age two months,” she said.

Cortese and colleagues concluded that nationally representative discharge databases have demonstrated usefulness in the monitoring of pertussis-related hospitalizations in infants; therefore, the effect of the new TDaP vaccines on infant pertussis should continue being monitored in adolescents and adults through these databases.

“We expected to find higher hospitalization rates using the discharge databases compared with rates based on the passive reporting system because case reporting requires additional efforts that might not always be completed,” Cortese said. “To monitor the pertussis burden among infants, it is valuable to use data sources that do not rely on reporting efforts.”

For more information:

• Cortese MM, Baughman AL, Zhang R, et al. Pertussis hospitalizations among infants in the United States, 1993-2004. Pediatrics. In press.

A 24-year-old man with no significant past medical history presents to the emergency department (ED) with a complaint of several episodes of a sensation of nearly blacking out. The episodes have occurred about 3-4 times over the 3 days before presentation. The duration of each episode has ranged from a few minutes to over an hour. The patient notes that he has felt his “heart beating really fast,” with associated light-headedness. He denies having any chest pain, shortness of breath, or nausea associated with these events. He cannot identify exacerbating or alleviating factors; specifically, he denies exertion as an inciting factor. The remainder of his review of systems is negative except for some mild chronic shortness of breath. The patient takes no medications at home and has no active medical conditions. He smokes 2-4 packs of cigarettes per day and has done so for 5-6 years. He denies any illicit drug use or recent use of over-the-counter medications or herbal remedies. He has no history of any significant cardiac disease or sudden cardiac death in his family.

On physical examination, the patient is afebrile, with a pulse of 65 bpm, a blood pressure of 120/84 mm Hg, and a respiratory rate of 15 breaths/min. His room air saturation reading is 100%. In general, he is well-appearing and in no acute distress. The patient’s neck examination shows no jugular venous distention. The heart sounds, including S1and S2, reveal no audible murmurs, rubs, or gallops. The apical impulse is nondisplaced and of normal impact. The lung sounds are diminished throughout, but there are no wheezes, rales, or rhonchi. He has no edema of the lower extremities, and the distal pulses are easily palpable. All other exam findings, including a neurologic examination, are unremarkable.

The patient is placed on a cardiac monitor, and an 18-gauge intravenous (IV) catheter is inserted into the antecubital fossa. Laboratory tests consisting of a complete blood count (CBC) and serum electrolytes are ordered. A portable chest radiograph reveals slight hyperinflation and hyperlucency of the lung fields, with a flattened diaphragm and central pulmonary artery enlargement. An electrocardiogram (ECG) is obtained (see Figure 1).

DISCUSSION

Preexcitation is characterized by an accessory pathway within the heart that conducts action potentials between the atria and ventricles outside of the normal conduction system (which conducts through the atrioventricular [AV] node-His-Purkinje system). The phenomenon was defined by Durrer et al in 1970, who stated that “preexcitation exists, if in relation to atrial events, the whole or some part of the ventricular muscle is activated earlier by the impulse originating from the atrium than would be expected if the impulse reached the ventricles by way of the normal specific conduction system only.”^[5] Of the various types of preexcitation syndromes, the most common is Wolff-Parkinson-White (WPW) syndrome.

WPW syndrome can be identified by a classic fusion QRS complex ECG pattern that is a combination of simultaneous normal conduction through the AV node and aberrant conduction through the accessory tract. This fusion QRS complex leads to particular ECG features that include a shortened PR interval (<120 msec) and a widened QRS complex with a delta wave representing preexcitation of the ventricle through the accessory pathway. The distinctive ECG pattern of the accessory pathway was initially described by Wolff, Parkinson, and White in 1930 as a bundle branch block with a short PR interval. Additionally, as mentioned, WPW syndrome is recognized as the most common form of ventricular preexcitation, although it likely represents a collection of pathologic conditions rather than a single structural abnormality.

Normal cardiac conduction of action potentials from the atria to the ventricles occurs exclusively through the AV node; the atrial impulses are subsequently propagated through a specialized conduction system (the AV-His-Purkinje system) and finally terminate in the ventricular myocardium. Action potential conduction through the AV node depends on slow inward calcium currents. In addition, the AV nodal system exhibits decremental conduction, which provides a protective effect; as the cardiac cycle is shortened (eg, the heart rate increases), there is decreased conduction through the AV node. This phenomenon limits the ventricular response to rapid atrial rates, such as those observed in atrial fibrillation or atrial flutter.

In preexcitation syndromes such as WPW, however, the action potential conducts to the ventricles at least partially through an accessory pathway termed the AV bypass tract or the bundle of Kent. Action potential propagation in the accessory pathway in WPW syndrome occurs through a rapid cellular influx of sodium. The consequence of the sodium-dependent action potential propagation mechanism is an accelerated conduction of impulses by the accessory bypass tracts, which leads to early activation of the ventricle as demonstrated by a shortened PR interval and a "slurred" QRS complex (ie, delta wave). Ventricular depolarization slowly spreads out from the bypass tract, while normal conduction that has been somewhat delayed through the AV node begins to conduct through the His-Purkinje system and spreads quickly to the remaining ventricular musculature. Although conduction velocity through the accessory pathway is faster than it is through the AV node, the accessory pathway often has a longer refractory period and, as such, is slower to recover excitability. Interestingly, the conduction of action potentials through the accessory pathway is nondecremental; therefore, the protective effect achieved by the AV node at higher heart rates is lost. These differences have important clinical implications. For example, a premature beat may conduct through the AV node normally while the accessory pathway remains refractory to conduction. The impulse then travels in a retrograde direction through the accessory pathway after ventricular depolarization, when it has recovered excitability. The consequence of this is the propagation of a reentry loop termed an orthodromic AV reciprocating tachycardia. This can then lead to rapid ventricular response rates that can degenerate into ventricular tachyarrhythmias. Rarely, antidromic tachycardias occur; conduction occurs in an anterograde direction through the accessory pathway and in a retrograde direction through the AV node.

Ventricular depolarization occurs through both the AV node-His bundle pathway and the accessory pathway; each pathway affects the ventricles by various degrees, depending on their relative activation times. As AV nodal conduction is delayed by either rapid atrial pacing or premature atrial beats, the accessory pathway contributes to a greater degree, resulting in a wider QRS morphology with an increasingly slurred delta wave. If the relative conduction time through the AV node is sufficiently delayed, total activation of the ventricle may occur through the accessory pathway.

The presence of accessory bypass tracts is not uncommon in the general population; however, less than half of the people with bypass tracts actually sustain a tachyarrhythmia. WPW syndrome affects approximately 0.15-0.2% of the general population, and of these individuals, 60-70% have no other evidence of heart disease. Mortality and morbidity associated with WPW syndrome occur as a result of associated dysrhythmias or from mistreatment of these dysrhythmias with inappropriate medications. Most studies report that the incidence of sudden death is in the 0-4% range. Men are affected more often than women,^[5] accounting for 60-70% of all cases. Although this disease affects people of all ages, it is typically first recognized in children and young adults who present to the ED or their primary care physician with symptoms secondary to a dysrhythmia. Genetic mutations have been identified (by mapping genetic defects to specific loci) that account for the increased incidence of WPW syndrome in certain families.^[2]

In patients with suspected WPW syndrome, evaluation should initially be directed at confirming the diagnosis and recognizing any potentially life-threatening arrhythmias. In patients with life-threatening arrhythmias, direct-current cardioversion should be immediately administered. In stable patients with tachyarrhythmias, an antiarrhythmic medication may be administered to terminate the arrhythmic episode, rather than immediately performing electrical cardioversion.

Studies have demonstrated that the best and most cost-effective treatment for patients with asymptomatic WPW syndrome is simple observation.^[5] Most patients with symptomatic arrhythmias, drug-refractory WPW syndrome, or significant life-threatening arrhythmias are treated with nonpharmacologic therapy. Surgical ablation, previously the standard technique for drug-refractory WPW syndrome, has been replaced by catheter-based procedures. Compared with surgical techniques, catheter ablation has comparable success rates, lower mortality and complication rates, and improved cost-effectiveness. Moreover, newer catheter mapping systems now allow shorter procedure times. Surgical ablation, however, may be necessary in patients in whom catheter ablation has failed. Because this patient had a symptomatic tachyarrhythmia, he underwent electrophysiologic mapping followed by transvenous catheter ablation. He has remained asymptomatic since this procedure.

Patients with infrequent or minimally symptomatic arrhythmias may be treated pharmacologically. The aim of pharmacologic therapy is to alter the electrophysiologic properties, such as the refractoriness or conduction velocity of the AV node or the accessory bypass tracts.

References

1. Calkins H. Radiofrequency catheter ablation of supraventricular arrhythmias. Heart. 2001;85:594-600. Abstract
2. Gollob MH, Green MS, Tang AS, et al. Identification of a gene responsible for familial Wolff-Parkinson-White syndrome. N Engl J Med. 2001;344:1823-31. Abstract
3. Josephson M, Zimetbaum P. The tachyarrhythmias. In: Kasper DL, Braunwald E, Hauser S, et al. Harrison’s Principles of Internal Medicine. 16th ed. New York, NY: McGraw Hill; 2005: 1301-1302.
4. Weinberger BM, Marinchak R, Kowey PR. Supraventricular arrhythmias. In: Crawford MH. Current Diagnosis & Treatment in Cardiology. 2nd ed. New York, NY: McGraw Hill/Appleton & Lange; 2003.
5. Singh VN, Sharma RK, Flaker G. Wolff-Parkinson-White Syndrome. eMedicine journal [serial online]. Last updated: July 10, 2006. Available at: http://www.emedicine.com/med/TOPIC2417.HTM.

AP, 3/12/08:  Deputies said a woman in western Kansas sat on her boyfriend’s toilet for two years, and they’re investigating whether she was mistreated.

Ness County Sheriff Bryan Whipple said a man called his office last month to report that something was wrong with his girlfriend.

Whipple said it appeared the 35-year-old Ness City woman’s skin had grown around the seat. She initially refused emergency medical services but was finally convinced by responders and her boyfriend that she needed to be checked out at a hospital.

“We pried the toilet seat off with a pry bar and the seat went with her to the hospital,” Whipple said. “The hospital removed it.”

Whipple said investigators planned to present their report Wednesday to the county attorney, who will determine whether any charges should be filed against the woman’s 36-year-old boyfriend.

“She was not glued. She was not tied. She was just physically stuck by her body,” Whipple said. “It is hard to imagine. … I still have a hard time imagining it myself.”

He told investigators he brought his girlfriend food and water, and asked her every day to come out of the bathroom.

“And her reply would be, ‘Maybe tomorrow,”’ Whipple said. “According to him, she did not want to leave the bathroom.”

The boyfriend called police on Feb. 27 to report that “there was something wrong with his girlfriend,” Whipple said, adding that he never explained why it took him two years to call.

Police found the clothed woman sitting on the toilet, her sweat pants down to her mid-thigh. She was “somewhat disoriented,” and her legs looked like they had atrophied, Whipple said.

“She said that she didn’t need any help, that she was OK and did not want to leave,” he said.

She was taken to a hospital in Wichita, about 150 miles southeast of Ness City. Whipple said she has refused to cooperate with medical providers or law enforcement investigators.

Authorities said they did not know if she was mentally or physically disabled.

Police have declined to release the couple’s names, but the house where authorities say the incident happened is listed in public records as the residence of Kory McFarren. No one answered his home phone number.

The case has been the buzz in Ness City, said James Ellis, a neighbor.

“I don’t think anybody can make any sense out of it,” he said.

Ellis said he had known the woman since she was a child but that he had not seen her for at least six years.

He said she had a tough childhood after her mother died at a young age and apparently was usually kept inside the house as she grew up. At one time the woman worked for a long-term care facility, he said, but he did not know what kind of work she did there.

“It really doesn’t surprise me,” Ellis said of the bathroom incident. “What surprises me is somebody wasn’t called in a bit earlier.”

FDA and Tibotec Therapeutics notified healthcare professionals of changes to the WARNINGS section of the prescribing information for Prezista (darunavir) tablets regarding the risk of hepatotoxicity. In clinical trials and postmarketing experience, drug induced hepatitis has been reported in patients receiving combination therapy with Prezista/ritonavir.

Appropriate laboratory testing should be conducted prior to initiating therapy with Prezista/ritonavir and patients should be monitored during treatment. Increased AST/ALT monitoring should be considered in patients with underlying chronic hepatitis, cirrhosis, or in patients who have pretreatment elevations of transaminases, especially during the first several months of Prezista/ritonavir treatment.

Read the complete 2008 MedWatch Safety Summaries including a link to the manufacturer’s Dear Healthcare Professional Letter and Prescribing Information for Prezista concerning this issue at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Prezista

Intro:  The security guard has been decorated for heroic action above and beyond the call of duty; also a free one-year subscription to The Emperor Club.  Meanwhile, the vacuum cleaner is emotionally distraught.  It has been medically evaluated and treated by the SANE team and is currently undergoing psychological counseling in a secluded hardware store.  Pregnancy prophylaxis was refused due to religious objections.

HealthCare Security Weekly, 3/10/08: 

A security guard at a London hospital reported finding a construction worker, who was supposed to be refurbishing offices at the facility, engaged in inappropriate behavior with a vacuum cleaner.

The construction worker was fired, reported United Press International. The security guard at Great Ormond Street Children’s Hospital said he saw the worker, who was supposed to be locking up at the building site, naked in the staff cafeteria with a Henry Hoover vacuum cleaner, The Daily Telegraph reported March 3.

The guard informed the construction worker’s employer and the construction company fired the man. When questioned by his bosses, the worker said he was vacuuming his underwear, which he claimed was “a common practice” in his native Poland. “That behavior is not acceptable, though it gave a few people a laugh,” the company told The Sun newspaper.

Well, you might as well scratch Eliot Spitzer off Hillary’s short list as a Vice-Presidential running mate.  Although “Vice”- President sounds quite appropriate!

From JAMA:  MICR stands for Minimally Interrupted Cardiac Resuscitation.   This technique concentrates on cardiac compressions (200 at a time) and early epinephrine without interposing interruptory ventilation techniques.  The researchers discovered that survival rates were greater.
http://omniphysicians.com/2008/03/12/micr/

Researchers are reporting that they can hack into the wireless access system of pacemakers.  They hypothesize that they have the ability to stop an implanted pacemaker or cause it to defibrillate.  Of course, this hypotesis hasn’t been tested on any patients yet, but they are inviting Dick Cheney to participate.
http://omniphysicians.com/2008/03/12/pacemakers-vulnerable-to-hackers/

Researchers from Scotland reported in the American Journal of Medicine that CRP can be used to gauge the potential outcome of a patient with pneumonia.  The level of CRP can be used to judge whether a patient will be able to go to Cedar Point this summer or should make a reservation with Coyle Funeral Home.
http://omniphysicians.com/2008/03/12/crp-a-marker-for-pneumonia-severity/

We’ve seen patients with chronic atrial fibrillation and on Coumadin who have PT INRs higher than the Dow Jones Industrial Average.  Now, the Chicago Tribune reports that researchers have created a device to be inserted in the atrium that can prevent clots from migrating.  If successful, this device may obviate the need to place these patients on Coumadin.
http://omniphysicians.com/2008/03/12/clot-catcher-in-atrial-fib-patients/

The media are agog over the recent finding that 1 in 4 teenage girls are infected with STD.  The other 3 girls just have bad breath.
http://omniphysicians.com/2008/03/12/1-in-4-teen-girls-with-std/

Clinical trials are suggesting that anemia-treating drugs like Epogen, Procrit, and Aranesp may make tumors worse and hasten a cancer patient’s death.  The FDA will meet this week to see if any advisory should be published.  They’ll make their recommendations after they stop giggling over Gov. Spitzer sexual peccadilloes.
http://omniphysicians.com/2008/03/12/anemia-drugs-might-make-tumors-worse/

This study that has just been published in JAMA concludes that rapid screening for MRSA in admitted patients does not reduce of nosocomial MRSA infections.
http://omniphysicians.com/2008/03/12/mrsa-screening/

Enjoy the day,

Paul R.

AP (3/12, Freking) reports that according to a study published in the journal Health Affairs, “[m]inorities are more likely than white patients to rate their healthcare as fair or poor, a view that is particularly true among Chinese-Americans, blacks born in Africa, and Vietnamese-Americans.”

Researchers at Harvard University and the Robert Wood Johnson Foundation conducted a survey of more than 4,000 adults. More than 90 “percent of whites rated their care as excellent or good.” However, “[t]hat percentage fell for most ethnic groups.”

Approximately 63 “percent of whites” said that they “were able to get an appointment on the same day or the…day after they became sick or injured,” but just “42 percent [of] Cuban-Americans and 39 percent [of] African-Americans born in the Caribbean” said that they were able to do so. Furthermore, while roughly 75 percent “of whites reported that their doctor listened carefully to them,” just “62 percent [of] Korean-Americans and 58 percent [of] those from Central America or South America” said that they had had the same experience.

NY Times, 3/12/08: To the long list of objects vulnerable to attack by computer hackers, add the human heart.

The threat seems largely theoretical. But a team of computer security researchers plans to report Wednesday that it had been able to gain wireless access to a combination heart defibrillator and pacemaker.

They were able to reprogram it to shut down and to deliver jolts of electricity that would potentially be fatal — if the device had been in a person. In this case, the researcher were hacking into a device in a laboratory.

The researchers said they had also been able to glean personal patient data by eavesdropping on signals from the tiny wireless radio that Medtronic, the device’s maker, had embedded in the implant as a way to let doctors monitor and adjust it without surgery.

The report, to published at www.secure-medicine.org, makes clear that the hundreds of thousands of people in this country with implanted defibrillators or pacemakers to regulate their damaged hearts — they include Vice President Dick Cheney — have no need yet to fear hackers. The experiment required more than $30,000 worth of lab equipment and a sustained effort by a team of specialists from the University of Washington and the University of Massachusetts to interpret the data gathered from the implant’s signals. And the device the researchers tested, a combination defibrillator and pacemaker called the Maximo, was placed within two inches of the test gear.

Defibrillators shock hearts that are beating chaotically and dangerously back into normal rhythms. Pacemakers use gentle stimulation to slow or speed up the heart. Federal regulators said no security breaches of such medical implants had ever been reported to them.

The researchers said they chose Medtronic’s Maximo because they considered the device typical of many implants with wireless communications features. Radios have been used in implants for decades to enable doctors to test them during office visits. But device makers have begun designing them to connect to the Internet, which allows doctors to monitor patients from remote locations.

The researchers said the test results suggested that too little attention was being paid to security in the growing number of medical implants being equipped with communications capabilities.

“The risks to patients now are very low, but I worry that they could increase in the future,” said Tadayoshi Kohno, a lead researcher on the project at the University of Washington, who has studied vulnerability to hacking of networked computers and voting machines.

The paper summarizing the research is called “Pacemakers and Implantable Cardiac Defibrillators: Software Radio Attacks and Zero-Power Defenses.” The last part refers to defensive possibilities the researchers outlined that they say would enhance security without draining an implant’s battery. They include methods for warning a patient of tampering or requiring that an incoming signal be authenticated, using energy harvested from the incoming signals.

But Mr. Kohno and Kevin Fu, who led the University of Massachusetts arm of the project, said they had not tried to test the defenses in an actual implant or to learn if anyone trying to use them might run afoul of existing patent claims.

Another participant in the project, Dr. William H. Maisel, a cardiologist who is director of the Medical Device Safety Institute at the Beth Israel Deaconess Medical Center in Boston, said that the results had been shared last month with the F.D.A., but not with Medtronic.

“We feel this is an industry-wide issue best handled by the F.D.A.,” Dr. Maisel said.

The F.D.A. had already begun stepping up scrutiny of radio devices in implants. But the agency’s focus has been primarily on whether unintentional interference from other equipment might compromise the safety or reliability of the radio-equipped medical implants. In a document published in January, the agency included security in a list of concerns about wireless technology that device makers needed to address.

Medtronic, the industry leader in cardiac regulating implants, said Tuesday that it welcomed the chance to look at security issues with doctors, regulators and researchers, adding that it had never encountered illegal or unauthorized hacking of its devices that have telemetry, or wireless control, capabilities.

“To our knowledge there has not been a single reported incident of such an event in more than 30 years of device telemetry use, which includes millions of implants worldwide,” a Medtronic spokesman, Robert Clark, said. Mr. Clark added that newer implants with longer transmission ranges than Maximo also had enhanced security.

Boston Scientific, whose Guidant division ranks second behind Medtronic, said its implants “incorporate encryption and security technologies designed to mitigate these risks.”

St. Jude Medical, the third major defibrillator company, said it used “proprietary techniques” to protect the security of its implants and had not heard of any unauthorized or illegal manipulation of them.

Dr. Maisel urged that patients not be alarmed by the discussion of security flaws. “Patients who have the devices are far better off having these devices than not having them,” he said. “If I needed a defibrillator, I’d ask for one with wireless technology.”

MedWire (3/12, Holmes) reports that “C-reactive protein (CRP) is an independent marker of severity in community-acquired pneumonia (CAP),” according to a study published in the American Journal of Medicine. In a study of 570 patients, James Chalmers and colleagues from the Royal Infirmary of Edinburgh “found that CRP levels <100 mg/l on admission were independently associated with reduced 30-day mortality (odds ratio [OR]=0.18), need for mechanical ventilation and/or inotropic support (OR=0.21), and complicated pneumonia (OR=0.05)." Furthermore, the researchers "found that CRP levels that fail to fall by 50 percent or more within 4 days of admission are independently associated with increased 30-day mortality (OR=24.5), need for mechanical ventilation and/or inotropic support (OR=7.1), and complicated pneumonia (OR=15.4)."

Chicago Tribune, 3/11/08:  A device called the Watchman could replace blood thinners as the therapy of choice for patients with atrial fibrillation if results from a study at Evanston Northwestern Healthcare prove fruitful.

The health-care system is participating in a multisite clinical trial for the device.

Atrial fibrillation patients are at much higher risk for stroke because the upper chambers of the heart quiver rather than beat regularly and forcefully, and blood can stagnate and form stroke-producing clots inside a small appendage that branches off the left atrium. The incidence of atrial fibrillation increases with age, affecting 2 percent of 60-year-olds and about 10 percent of 80-year-olds.

The Watchman is a small wire and polyester fabric trap designed to fit snugly into the left atrial appendage and catch any clots. Scar tissue forms over it until the entire appendage is sealed off, eliminating the source of clots and the need for blood thinners.

“The point of this trial is to compare the device to Coumadin,” a blood thinner that prevents clots from forming, said Dr. Ted Feldman, director of the Cardiac Catheterization Laboratory at ENH and principal investigator of ENH’s Watchman trial. Coumadin “is a great blood thinner, [but] there are two huge problems with it. One is it’s really difficult to use. Many dietary factors affect it…and there isn’t a standard dose.”

Blood thinners risky

Patients on warfarin, the generic name for Coumadin, must get their blood checked at least once a month to make sure they aren’t being “underthinned,” which may lead to clots and stroke, or “overthinned,” which puts them at high risk for bleeding.

The second problem these patients have to contend with — even those whose dose is regulated — is bleeding and bruising. Everyday activities are riskier for those whose blood is slow to clot, and an otherwise survivable car accident can be deadly.

This problem is what led atrial fibrillation patient Milton Albritton, 65, of Park Forest, to enroll in the trial. Albritton enjoys “fiddling” in his garage. “If I need some shelves built, just any little job, I like to do those things,” he said. “When you’re doing things like that, you might bump up against something. Changing the oil in the car, you might bump your arm on it. And the next thing I know, I’m looking at my arm and I have these purplish spots on it. Or on my abdomen [after] looking under the hood of the car.”

And Albritton was sidelined by a simple nosebleed. “I was getting ready to go to church, and my left nostril just began to bleed. Blood just dripping.”

When it didn’t stop, he called his doctor. “She told me to put some ice on it, hold my head back 30 minutes and hold my nose, and if it didn’t stop, to go to the emergency room. I went to the hospital. … I was in the hospital all afternoon, and they finally had to put a balloon up there to stop the bleeding.”

Still in trial phase

Feldman said that the Watchman device is compressed into a narrow tube and fed through a vein in the groin and up into the heart. “The downside for any procedure is a night in the hospital. The procedure itself is done under general anesthesia.” Because the device is still in the trial phase, no complication rate has been determined yet, but Feldman said “all of these basic types of procedures have about a 1 percent significant complication rate, [such as] damaging the heart wall, requiring extra days in the hospital to manage bleeding around the heart.”

Forty-five days after having the Watchman device inserted, Albritton was told the appendage had completely scarred over. He is now off Coumadin.

About 10 Chicago-area atrial fibrillation patients are enrolled in this trial. Anyone interested in participating can call Dale Seifert, ENH’s research coordinator for cardiology, at 847-570-2368. For more information on the device, visit the manufacturer’s Web site at atritech.net.