FDA approves devices for heart failure patients

The U.S. Food and Drug Administration today approved a new indication for three cardiac resynchronization therapy defibrillators (CRT-D) used to treat certain heart failure patients. The new use is for patients with an abnormality known as left bundle branch block, which occurs when there is delayed activation and contraction of the left ventricle. The three devices, all manufactured by Boston Scientific Corp., are intended to treat patients with left bundle branch block who have either mild heart failure or heart failure with no apparent symptoms.

The CRT-D device combines two functions. As an implantable cardioverter defibrillator (ICD) it senses dangerous abnormal heart rhythms and then attempts to shock the heart back into a normal rhythm. As cardiac resynchronization therapy, it generates small electrical impulses to coordinate the beating of the left and right ventricles so that they work together more effectively to pump blood throughout the body.

CRT-Ds are to be used as an addition to, not a replacement for, heart failure drug therapy.

“This approval allows heart failure patients with left bundle branch block to benefit from this therapy," said Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health. “The FDA is pleased to safely make this new technology available for a greater number of heart failure patients."

The FDA based its approval on the results of the 1,820-patient Multicenter Automatic Defibrillator Implantation Trial with Cardiac Resynchronization Therapy (MADIT-CRT) clinical study. The study which followed 1,820 patients for an average of nearly three years at 110 centers in the United States, Europe, Canada, and Israel. It compared CRT-D therapy to ICD-only therapy in specific heart failure patients to determine whether it reduced the risk of death and heart failure. In patients with left bundle branch block, who represented 70 percent of the study group, CRT-D showed a reduction in the risk of death and heart failure by 57 percent, as compared to ICD alone.

The rate of complications was considered to be acceptable by the FDA for this device, however, physicians should adequately inform patients about potential complications.

As a condition of FDA approval, Boston Scientific must conduct two post-approval studies. One study will evaluate complications and long-term mortality benefits of CRT-D in patients with left bundle branch block identified through the National Cardiovascular Data Registry. The other will follow patients from the original MADIT-CRT clinical study every six months for five years to assess long-term mortality benefits of CRT-D vs. ICD.

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Cardiac Science Notifies AED Customers of Nationwide Voluntary Medical Device Correction

Cardiac Science Corporation [NASDAQ: CSCX] is initiating a voluntary field correction after it was determined certain automated external defibrillators (AEDs) may experience a rare product issue in which the AED may not be able to deliver therapy during a resuscitation attempt. Device failure may affect resuscitation of the patient, which could lead to serious adverse events or death. These AEDs have electronic components which may fail and the failure may not be detected by the device's periodic self-tests. The affected models include the Powerheart 9300A, 9300C, 9300D, 9300E, 9300P, 9390A, 9390E, and CardioVive 92531, 92532, and 92533 devices.

Cardiac Science has received a total of 64 complaints concerning four resistors within certain AEDs. Two of these complaints were associated with a failure to deliver therapy. This issue is predicted to occur in approximately one in 75,000 AEDs manufactured between August 2003 and August 2009. The company has also received 114 complaints regarding "Service Required" messages resulting from a specific relay switch failure. There have been no reported instances where this issue has resulted in an inability to deliver therapy.

Until a correction is available in May, 2010, the company strongly advises customers to check the status indicator on the front of the AED and follow the procedures documented in the materials accompanying the AED. The company advises that customers leave their AEDs in service.

"When customers choose a product from Cardiac Science, they expect outstanding reliability," said Dave Marver, president and chief executive officer. "We understand the role our products play in public health and are taking appropriate measures to further improve the performance of our products."

The company has implemented more stringent testing of the components and all AEDs produced since August, 2009 are unaffected. Customers in possession of an AED that may exhibit either of these issues will be notified immediately. A software update to address the resistor issue will be available by May, 2010. This software update will enhance the AED's self-test capabilities and improve detection of the issue. In the interim, the company advises customers to keep their AEDs in service and follow the normal testing and maintenance procedures found in the Operator and Service Manual. A copy of these procedures is available at www.cardiacscience.com/AED175. At this site, customers may confirm if their AED is affected and register for automatic e-mail reminders to conduct scheduled maintenance.

If the AED is not rescue ready (the indicator is red) customers should contact the company immediately at 425.402.2000 (option 1) within the United States. Outside the US contact +44.161.926.0011 or the local Cardiac Science representative. Customers can also email the company at AED175@cardiacscience.com.

Forward-Looking Statements

This press release contains forward-looking statements. The word "believe," "expect," "intend," "anticipate," variations of such words, and similar expressions identify forward-looking statements, but their absence does not mean that the statement is not forward-looking. Forward looking statements in this press release include, but are not limited to, predictions of AED component failure rates, the availability of software updates to improve detection of the component issue, and the effectiveness of the planned software update. These are forward-looking statements for purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995. Actual results and performance may vary significantly from those expressed or implied in such statements. Factors that could cause or contribute to such varying results and other risks are more fully described in the Annual Report on Form 10-K filed by Cardiac Science Corporation for the year ended December 31, 2008, as updated by subsequent quarterly reports on Form 10-Q. Cardiac Science Corporation undertakes no duty or obligation to update the information provided herein.

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Statins May Worsen Symptoms in Some Cardiac Patients

/PRNewswire/ -- Although statins are widely used to prevent heart attacks, strokes, and other cardiovascular disorders, new research shows that the class of drugs may actually have negative effects on some cardiac patients. A new study presented at CHEST 2009, the 75th annual international scientific assembly of the American College of Chest Physicians (ACCP), found that statins have beneficial effects on patients with systolic heart failure (SHF), but those with diastolic heart failure (DHF) experienced the opposite effect, including increased dyspnea, fatigue, and decreased exercise tolerance.

"Systolic heart failure is most often due to coronary artery disease and appears to have more of an inflammatory component than diastolic heart failure," said Lawrence P. Cahalin, PhD, PT, Northeastern University, Boston, MA. "It is possible that statins would help patients with systolic heart failure more than patients with diastolic heart failure due to the cholesterol-lowering and anti-inflammatory effects of statins."

Researchers from Northeastern University and Massachusetts General Hospital, Boston, MA, retrospectively reviewed the charts of 136 patients with heart failure in order to examine the effect of statins on pulmonary function (PF) and exercise tolerance (ET) in patients with DHF vs. SHF. A non-statin group (82 percent of patients had DHF) of 75 patients was compared with a statin group (72 percent of patients had DHF) of 61 patients. Atorvastatin was prescribed in 75 percent of the patients on statins.

Results of the analysis showed that overall PF and ET of patients in the statin group were significantly lower than patients in the non-statin group. Further subgroup analyses revealed that PF measures in the DHF statin group were 12 percent lower than PF measures in the DHF non-statin group. Furthermore, the amount of exercise performed by patients with DHF who were on a statin was almost 50 percent less than patients with DHF not on a statin.

"Some patients with diastolic heart failure may be more prone to the adverse effect of statins on muscle. It may be that patients with particular preexisting factors will experience unfavorable results from statin therapy, including exercise intolerance, dyspnea, and fatigue," said Dr. Cahalin.

Although the PF and ET measures in the SHF statin group were not significantly greater than in the SHF non-statin group, the PF measures were 11 percent to 14 percent higher, and the peak ET measures were 2 percent to 7 percent higher than the PF and ET measures of the SHF non-statin group, suggesting that statins did benefit patients with SHF.

"Not all statins are alike and not all patients are alike. Some statins are stronger than others and are likely to act differently, given particular patient characteristics, and produce different degrees of wanted and unwanted effects," said Dr. Cahalin. "In our continuing study, we hope to identify patient characteristics that are associated with favorable and less than favorable results from statin therapy."

Although the new data suggest that statins may actually worsen symptoms in patients with DHF, researchers feel that the benefits of using statins in patients with SHF and DHF outweigh the risks.

"Due to beneficial effects on lipids and other cardiovascular factors, statins are becoming a standard treatment for many patients with or without systolic or diastolic heart failure. It is likely that the use of statins for these conditions will continue to increase," said Dr. Cahalin. "However, if patients taking a statin are short of breath, fatigued, and unable to exercise or perform functional tasks, then exams of muscle strength and endurance, as well as pulmonary function and exercise tolerance, are warranted."

"Statins provide significant benefits for patients with cardiovascular disease," said Kalpalatha Guntupalli, MD, FCCP, President of the American College of Chest Physicians. "However, as for any new medication prescribed, clinicians should closely monitor the effects that different types of statins have on individual patients."

CHEST 2009 is the 75th annual international scientific assembly of the American College of Chest Physicians, held October 31-November 5 in San Diego, CA. The ACCP represents 17,400 members who provide patient care in the areas of pulmonary, critical care, and sleep medicine in the United States and throughout the world. The ACCP's mission is to promote the prevention and treatment of diseases of the chest through leadership, education, research, and communication. For more information about the ACCP, please visit the ACCP Web site at www.chestnet.org.

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Arrow International Announces Worldwide Voluntary Recall of Intra Aortic Balloon Pump (IAB) Catheters

Teleflex Medical announced April 13 that the U.S. Food and Drug Administration (FDA) has classified the voluntary medical device recall initiated on February 2, 2009 by Arrow International’s Cardiac Care Division involving volume connectors for its 30cc, 40cc and 50cc Intra Aortic Balloon Pump (IAB) Catheters as a Class 1 recall. FDA defines Class I recalls as, “a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.”

This recall is being conducted because a fault in the connector of the pump tubing assembly may result in the volume setting on the pump defaulting to 2.5 cc or 5 cc, rather than the appropriate 30, 40, or 50 cc volume. In patients exhibiting moderate to severe myocardial ischemia or low perfusion states, prolonged exposure to the low default volume may fail to decrease ischemia and increase perfusion, leading to organ injury or infarct and may result in patient death. Prolonged exposure to a device which is inflated to less than 2/3 full could also result in thrombus formation on the IAB and possible subsequent systemic or cerebral thromboembolism.

Instructions contained in the operator’s manual fully describe the necessary warnings and precautions that will identify the issue. The recall notice restates these instructions and references the sections in the owner’s manual. If these instructions are followed, the issue for which the product was recalled can be discovered immediately, and the product can be removed and replaced.

Arrow International notified both domestic and foreign hospitals and distributors via an Urgent Medical Device recall letter dated February 2, 2009 that the company had become aware that the blue connector for the 40cc IAB was not properly recognized by the Arrow Intra-Aortic Balloon Pump (IABP) system. This recall involved the retrieval of unused product, issuance of mitigation instructions for patients and/or facilities in critical need, and the replacement of pump tubing assemblies.

At this time, there have been 25 complaints of this issue. There have been no reports of patient injury as a result of this issue. Approx. 423 lots are affected by this recall for a total 45,211 units.

PRODUCTS AFFECTED: 30/40/50 CC IAB Catheters:

PRODUCT CODES: IAB-04830-U, IAB-04840-U, IAB-05830-LWS, IAB05830-U, IAB-05840-U, IAB-05840-LWS, IAB06830-U, IAB06840-U, IAB-S730C, IAB-S840C, IAB-R950-U, IAK-02692, IAK-02693, and IAK-02691.

A list of products and lot numbers affected by this recall as well as the original recall notice can be found at Arrow’s website:

http://www.arrowintl.com/iab_recall.asp

Consumers with questions may contact the company at 1-800-523-8446; 8am to 8pm, ET, Monday through Friday, for international calls 001-919-361-4062; 8am to 5pm, ET, Monday through Friday.

Any adverse reactions experienced with the use of this product, and/or quality problems can also be reported to the FDA’s MedWatch Program by phone at 1-800-FDA-1088, by Fax at 1-800-FDA-0178, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.

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Heart Disease: An Epidemic For Firefighters

/PRNewswire/ -- H. Robert Superko, MD, principal investigator in the landmark FEMA-sponsored study of firefighters aged 40 and over conducted at Saint Joseph's Hospital in Atlanta, released preliminary findings in the world's first study of first responders at risk of suffering sudden death or other significant cardiac events. Firefighters are known to have a three hundred percent increased risk for cardiac disease as compared to other segments of the population.

"Preliminary findings show that one third of firefighters had heart disease that is unrelated to traditional risk factors, such as high cholesterol," says Dr. Superko. "Those results are astounding and point at job duties and environment as the primary determinants for early death in our country's first responders."

Dr. Superko, recognized as a leading expert on lipids, cholesterol and advanced metabolic markets and their contribution to heart disease, and his team performed a comprehensive, scientific battery of sophisticated blood and imaging tests on three hundred firefighters in Gwinnett County, Georgia. Gwinnett County first responders were identified for the study following an emotional report by Fire Chief Steve Rolader, following the sudden death of one of his firefighters from cardiac arrest while fighting a house fire.

"This wasn't the first firefighter in my department to die but I wanted to do something to make it among the last," says Chief Rolader. "This man was 53 years old, in great physical shape and he had no known symptoms of heart disease. We also had lost several newly-retired firefighters to sudden cardiac death. There had to be a way to stop it."

Study volunteers underwent a comprehensive genetic screen of more than a million genes including newly identified KIF6 (statin responsiveness gene) and 9p21 (myocardial infarction gene), advanced phenotype (blood) and imaging analyses, diet and exercise review over the year-long study. Results and explanations were presented to the groups followed by individual consultations. Complete statistical and comprehensive genetics results are expected this year.

According to Dr. Superko, stress and psychological pressures related to the job, as well as diet, exercise issues and inherent personality, interacting with a genetic predisposition to heart disease, probably have tremendous impact on the risk of heart attack in these first responders.

"Imagine being awakened from a dead sleep by a loud, shrieking siren several times during the night, responding through the rush of adrenaline, carrying a hundred pounds of equipment on your back, and meeting people at the very worst possible moments in their lives every day and you can begin to understand the toll it takes on the first responders," says Superko. "And, consider the emotional and psychological stress they encounter each day as they respond to society's most brutal moments from murders to car wrecks and death. Finally, those who serve as first responders have a mind-set and a desire to help people. They certainly bring a competitive nature to the job but also a profound desire to help and to do the best for others. All these elements create an environment that puts them at an increased risk for cardiac disease."

In response to the growing awareness to issues of diet and exercise, Gwinnett Fire Department has instituted exercise programs within local firehouses and the county now re-reimburses for fitness club memberships. The department also educates firefighters on proper diet and nutrition with one-on-one opportunities as well as "lunch and learn' programs in the station houses. And, over the years, the traditional firehouse alarm in Gwinnett stations has been replaced with softer alarms and even-voiced prompts to awaken sleeping first responders.

As a result of the study, Saint Joseph's Hospital and Dr. Superko's team implemented a two month screening program for all Atlanta first responders (firefighters, Police and EMS) regardless of age in order to provide them with some basic and advanced diagnostic tests at prices affordable to firefighters.. Several physicians are providing their services free of charge.

"There are tremendous costs associated with early deaths of our first responders in every community as we lose men and women in their 30s, 40s and 50s who are our first line of defense but who don't live to perform their jobs for very long," says Chief Rolader. "With the results of this study, we can implement programs across the country that will save lives."

Final results are expected to be submitted for presentation consideration at the annual American Heart Association meeting.

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FDA Approves Cardiac Adhesion Barrier for Pediatric Use

The U.S. Food and Drug Administration today announced its approval of a device that reduces the severity of adhesions in children undergoing open-heart surgery.

Repel-CV is a synthetic film barrier inserted over the heart just before a surgeon closes the chest following an open-heart procedure. During the early healing stages, the temporary, absorbable barrier helps reduce the severity of post-surgical adhesions.

Adhesions are bands of scar tissue that develop after surgery, infection, or other trauma. The bands can develop in any part of the body but are most commonly found in the abdomen, pelvis, or chest. Cardiac adhesions bind the outer membrane of the heart to surrounding tissue, which may restrict heart activity and complicate any additional surgical treatment. While scar tissue is part of the body’s natural healing response, adhesions can become densely fibrous and difficult to surgically navigate, which can pose problems for patients who require repeat surgeries.

In the United States, there are 350,000 to 400,000 children with congenital cardiac abnormalities. Many neonatal and infant patients must undergo multiple surgeries before their defect is corrected while other children require additional operations as they grow. This product gives physicians another tool to help decrease this type of complication that may occur.

Repel-CV is intended for children who are likely to require additional heart surgery. In a clinical study, patients who received Repel-CV were found to have less area of severe adhesions—21 percent of the surgical site. Patients who did not receive Repel-CV were found to have severe adhesions occupying 47 percent of the surgical site.

“Designing and testing medical devices for children is challenging because they are still growing,” said Daniel G. Schultz, director of FDA’s Center for Devices and Radiological Health. “Approval of Repel-CV is an example of FDA’s commitment to work with regulated industry to make more safe and effective pediatric medical devices available.”

Repel-CV is manufactured by SyntheMed Inc. in Iselin, N.J.

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Poor Perioperative Blood Pressure Control Linked to 30-Day Morbidity and Mortality in Cardiac Surgery Patients

Business Wire - The Medicines Company (NASDAQ: MDCO) announced October 21, 2008, that poor blood pressure control during cardiac surgery is associated with a higher risk of 30-day death, stroke, myocardial infarction and renal dysfunction, compared to patients with tight blood pressure control, according to a post-hoc analysis of the ECLIPSE trial. The data were presented at the American Society of Anesthesiologists (ASA) 2008 Annual Meeting.

“In this analysis, what we found was clear: the worse the blood pressure control, the poorer the outcome in these cardiac surgery patients,” said Solomon Aronson, M.D., Professor of Anesthesiology, Duke University School of Medicine. “These data support the need to more effectively manage blood pressure in the surgical and critical care settings.”

The ECLIPSE trial enrolled 1,964 cardiac surgery patients in one of three randomized, open-label trials comparing Cleviprex™ (clevidipine butyrate) injectable emulsion to nitroglycerin, sodium nitroprusside or nicardipine. In this post-hoc analysis, 1507 ECLIPSE patients were stratified by precision of blood pressure control measured as excursions and time out of a pre-specified range. Adverse outcomes, assessed as death, myocardial infarction, stroke and renal dysfunction at 30 days post-discharge, were significantly higher in patients with poor blood pressure control (14.4%) than in patients with tight blood pressure control (8.8%).

“These critical new findings underscore the risk posed by uncontrolled blood pressure during cardiac surgery and emphasize the need for tight blood pressure control in these patients,” said James Ferguson, M.D., Vice President, Global Medical, Surgical and Critical Care, The Medicines Company. “Cleviprex, recently approved by the FDA, provides physicians with an important, new clinical tool for achieving rapid and predictable blood pressure control.”

Additional post-hoc data from the pivotal ECLIPSE program, involving patients undergoing cardiac valve surgery, will be presented at the American College of Chest Physicians (ACCP) annual meeting in Philadelphia on Tuesday, October 28, 2008.

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FDA Approves Software Update that Identifies Potential Defibrillator Lead Fractures

The U.S. Food and Drug Administration today announced approval of a software update from Medtronic that will help detect fractures of the company's Sprint Fidelis cardiac defibrillator lead. The new software package will alert both patients and physicians of a potential lead fracture. This will enable early intervention and lower the risk of serious complications.

“This new software modification will provide Sprint Fidelis patients with the reassurance that their defibrillator is being monitored around the clock,” said Daniel Schultz, M.D., director of the Center for Devices and Radiological Health, FDA. “While the software doesn't fix the fracture itself, it may help identify the fracture earlier, allowing patients to see their physicians sooner.”

Implantable defibrillators are used to treat patients at risk of experiencing life-threatening heart rhythm abnormalities. Should an abnormality occur, the defibrillator delivers a pulse of energy through a lead, a thin electronic wire, shocking the heart back into normal rhythm.

The Sprint Fidelis lead, the subject of an October 2007 Medtronic recall, was prone to fracture in a small number of patients, potentially causing the lead to deliver unnecessary shocks or not operate at all. Most of the patients with the Sprint Fidelis lead still have the device implanted because of the surgical risk associated with removal, and are being monitored by their health care providers for potential fracture.

Medtronic's new software feature, called the Lead Integrity Alert, issues an audible alert once it detects signals that could indicate that the lead has fractured, and then repeats the alert every four hours until a physician can reset the defibrillator. In addition to an audible alert, the new software also modifies the device settings so the defibrillator has more time to consider whether a lead fracture or an abnormal heart rhythm has occurred, a change intended to reduce the number of inappropriate defibrillator shocks. The physician can download the Lead Integrity Alert feature onto Medtronic implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators.

Medtronic has agreed to actively monitor the performance of the new software feature in actual use, which will allow both the company and FDA to ensure that the device is protecting patients as intended.

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Transplantation of Kidneys from Black Cardiac-Death Donors Provide Black Recipients with the Best Long-Term Survival

Contrary to prevailing assumptions, Johns Hopkins researchers have shown that kidneys recovered from black donors who died from cardiac death offer the best survival rate for black recipients of a deceased-donor kidney.

This discovery, released online this week and appearing in the October 2008 issue of the Journal of the American Society of Nephrology, challenges the long-held belief that kidneys from white brain-death donors offers the best deceased-donor transplant survival rate for either black or white recipients.

“Our findings indicate that increased use of kidneys from cardiac-death donors could help reduce the organ shortage and improve outcomes for black kidney transplant recipients,” says lead author Jayme Locke, M.D., M.P.H., of the Department of Surgery at Johns Hopkins.

Locke and a team of Johns Hopkins researchers examined the outcomes of more than 25,000 black adults who received a deceased-donor kidney transplant between 1993 and 2006.

Results showed that black recipients who received a kidney from a black cardiac-death donor had a 70 percent reduction in the risk of kidney loss and a 59 percent reduction in risk for death when compared to black recipients who received a kidney from a white brain-death donor.

“Our data is consistent with the previous observation that black recipients seem to do better with kidneys from white brain-death donors than they do with kidneys from black brain-death donors or white cardiac-death donors, however, the fact that black recipients have the best outcomes with kidneys from black cardiac-death donors is significant,” says co-lead author Daniel Warren, Ph.D., of the Department of Surgery at Johns Hopkins.

He says that the exact mechanisms responsible for racial differences in outcomes after kidney transplantation are not known, however, the results suggest that the genetic background of the donor and recipient likely have a significant impact on long-term outcomes.

“We believe that an improved understanding of the molecular consequences of cardiac and brain death is critical to improving outcomes for all kidney transplant recipients and warrants further investigation,” he added.

There are currently more than 70,000 Americans waiting for kidney transplants. Only about 600 deceased-donor kidneys donated after cardiac death are currently used for transplantation versus 7,000 donated after brain death.

This discrepancy is due in part to the belief that kidneys that are exposed to cardiac death generally suffer more damage than kidneys that are exposed to brain death.

“Our results show this is not always true, and that is significant news for all patients waiting for a kidney,” says Locke.

Other researchers who worked on this study from Johns Hopkins include Robert Montgomery, M.D., Ph.D.; Andrew Cameron, M.D.; Joseph Melancon, M.D.; Dorry Segev, M.D.; Andrew Singer, M.D., Ph.D.; Christopher Simpkins, M.D., M.P.H.; Andrea Zachary, Ph.D.; Francesca Dominici, Ph.D.; Mary Leffell, Ph.D.; and Deborah McRann, B.S.N.

JAMA Revisits Classic Hopkins Blue Baby Study That Revolutionized Cardiovascular Medicine

A Johns Hopkins study published 63 years ago will make an encore appearance in the July 16 issue of the Journal of the American Medical Association (JAMA) as part of a year-long retrospective celebrating JAMA's 125th anniversary by revisiting papers that changed the course of modern-day medicine. Full text of the original paper is available online.

The now-classic "blue baby" report by pediatric cardiologist Helen Taussig (1898-1986) and surgeon Alfred Blalock (1899-1964) first appeared in JAMA on May 19, 1945. In their paper, Taussig and Blalock described for the first time the physiology of tetralogy of Fallot, one of the most common congenital malformations of the heart that was poorly understood at the time, considered inoperable and ultimately fatal. The malformation causes inadequate blood flow from the heart to the lungs and profound lack of oxygen in the blood, giving an infant's skin its hallmark bluish hue, hence "blue baby."

In addition, the paper described the first three operations in medical history designed to alleviate the defect using a special "shunt" technique that increased blood flow from the heart to the lungs. Children undergoing the surgery experienced an immediate and dramatic improvement while still in the operating room. When their oxygen-starved bodies were finally flushed with oxygen-rich blood, their bluish complexions turned a healthy pink color, an observation that prompted Blalock to exclaim famously after surgery number three, "The boy's a lovely color now."

At the time, Taussig and Blalock almost certainly knew their work would dramatically change treatment of heart disease, and records at Johns Hopkins show that hundreds and hundreds of parents sought help for their children in the months that followed. The study also revolutionized pediatric cardiology, a then nascent field, and ushered in a new era of cardiac surgery. In hindsight, it also altered the course of academic medicine, according to Johns Hopkins Children's Center cardiac specialists writing in a July 16 JAMA commentary accompanying the reprint summary of the original paper.

Historians, filmmakers and journalists have widely told the story of the research and eventual surgical solution, which began with an idea from Taussig, who took it to Blalock, who first sketched a surgical approach to the repair. But it was Vivien Thomas (1910-1985), a black surgical technician, at the time working as a lab and office assistant with Blalock, who was instrumental in developing the necessary procedure and instrumentation in dogs.

This mélange of disciplines as disparate as pediatric cardiology, surgery and anesthesiology working toward treatment of a single disorder became and to date remains the model for progress and innovation in medicine.

"Not only did the team's unprecedented collaboration in effect give birth to pediatric cardiology and led to the first successful treatment of this fatal heart defect, but it later became the prototype of the bench-to-bedside approach, a staple in academic medicine today," says Anne Murphy, M.D., an author on the commentary and a pediatric cardiologist at Johns Hopkins Children's Center.

In the decades that followed, the teamwork by Taussig, Blalock and Thomas also foreshadowed Johns Hopkins' efforts to eliminate racial and gender inequalities in academic medicine. In the 1940s, at Johns Hopkins, the venerable citadel of medicine, Taussig, a woman, and Thomas, an African-American, teamed up with Blalock, a white male surgeon -- a diverse and brilliant crew whose combined talent and expertise pioneered a surgery that has saved millions of lives worldwide.

Taussig went on to achieve the status of a full professor at Johns Hopkins -- one of the first women to do so -- but Thomas' role was not fully acknowledged until much later, the JAMA commentators point out, and the original paper did not credit Thomas' contributions.

"The collaboration awakened everyone to the fact that talented people like Thomas, who would have clearly been a superb surgeon, were marginalized, and medicine suffered for it," says commentary co-author Duke Cameron, M.D., head of pediatric cardiac surgery at Johns Hopkins. "It was a realization that drove much of Hopkins' subsequent efforts toward equality and diversity."

In 1976, Hopkins gave Thomas an honorary doctoral degree and appointed him instructor in surgery. Today, one of the four advisory colleges for medical students at Hopkins is named for Thomas. Every entering class learns about Thomas' story and his contributions to modern medicine.

Four out of 1,000 U.S. babies are born with heart defects, such as tetralogy of Fallot. Worldwide, nearly 1 million babies are born with heart defects, researchers estimate.