At the sleep research meeting in San Antonio this year, there were signs of an impending pharmaceutical arms race in the realm of narcolepsy.
The big fish in a small pond, Jazz Pharmaceuticals, was preparing to market its recently FDA-approved medication: Sunosi/solriamfetol. Startup Harmony Biosciences was close behind with pitolisant, already approved in Europe. On the horizon are experimental drugs designed to more precisely target the neuropeptide deficiency in people with classic narcolepsy type 1 Read more
Nature Medicinehas a nice feature from Jeanne Erdmann highlighting the debate over how long donated blood can be stored. It sets the stage for two prospective clinical trials (RECESS and ABLE), which recently concluded but are still being analyzed. The trials were looking at how the age of stored blood affects patients undergoing cardiac surgery or in intensive care, respectively. Erdmann alsoÂ mentions that the NIHâ€™s Clinical Center already has tightened its standards for blood storage time.
Emory Blood Bank director John Roback and cardiologist Arshed Quyyumi have been participants in this debate, both theoretically and experimentally. In 2011, they proposed that depletion of the messenger molecule nitric oxide limits the benefits donated blood can provide to patients. In addition to nitric oxide depletion, the â€œstorage lesionâ€ is likely to include several changes, such as lysis of red blood cells, mechanical alterations in the remaining cells, and other chemical changes.
Since then, Emory research has shown that transfusion of donated blood more than three weeks old results in impaired blood vessel function in hospitalized patients, but in contrast, not in healthy volunteers. This informationÂ could allow doctors to prioritize fresher blood for patients with cardiovascular diseases.
John Puskas, chief of cardiac surgery at Emory University Hospital Midtown, recently had an editorial in the journal Circulation on the topic of coronary bypass surgery.
John Puskas, MD
Specifically, he says that many cardiac surgeons are reluctant to employ bilateral internal thoracic artery grafts (as opposed to a single graft), even though there is a long-term benefit, because of perceived risk of infection and suboptimal financial incentives.
Puskas’ key message paragraph was so clear that it demands reposting here:
Why are American surgeons doing so few BITA [bilateral internal thoracic artery] grafts? Fundamentally, U.S. surgeons are responding to their practice environment, especially to a fear of deep sternal wound infection in an increasingly obese, diabetic population of patients. The surgeon pays a large and immediate political price for a deep sternal wound infection and receives relatively little credit for the extra years that BITA grafting adds to a patient’s life in the future. There is also a relative Ray Ban outlet financial disincentive to perform BITA grafting: incremental payment for the second internal thoracic artery graft is small considering the extra time required in the operating room. Moreover, the Centers for Medicare and Medicaid Services no longer reimburse for extra care necessary for treatment of mediastinitis [internal chest inflammation/infection] after cardiac surgery, because this is now deemed a never event. Thus, surgeons, who are increasingly employed by hospitals and hospital systems, are under intense pressure to perform CABG surgery that is safe and cost-effective according to short-term metrics.
Puskas and his colleagues have published an analysis of bilateral vs single grafting at Emory, as well as a proposed metric for when single grafting should be used in the context of patients with diabetes:
Our present practice is generally to use BITA grafting in patients who are <75 years, have suitable coronary artery targets, are not morbidly obese, and whose glycosylated hemoglobin level is <7.0% to 7.5%.
Emory University Hospital is one of about 20 hospitals nationwide, and the only site in Georgia, to study this new technology – with 75 patients receiving new valves at Emory since the clinical trial started in October 2007. Researchers hope to receive U.S. Food and Drug Administration approval in late 2011.
The life threatening heart condition affects tens of thousands of Americans each year when the aortic valve tightens or narrows, preventing blood from flowing through normally.
Peter Block, MD
Peter Block, MD, professor of medicine, Emory School of Medicine, and colleagues are performing percutaneous aortic valve replacement as part of a Phase II clinical trial, comparing this procedure with traditional, open-heart surgery or medical therapy in high-risk patients with aortic stenosis.
The procedure provides a new way for doctors to treat patients who are too ill or frail to endure the traditional surgical approach.
During the procedure, doctors create a small incision in the groin or chest wall and then feed the new valve, mounted on a wire mesh on a catheter, and place it where the new valve is needed.
There have been tremendous advances in cardiac surgery over the years. Physicians can now operate on children with heart defects in the first month or week of their lives. But very little is known about how the human heart develops especially in that first year after birth.
Emory and Childrenâ€™s Healthcare of Atlanta researcher Mary Wagner, PhD, is leading a project looking at how the heart develops during the first year of life. This is critical, she says, because childrenâ€™s hearts respond differently to medications and surgery than adultsâ€™ hearts, and many treatments currently available to pediatric heart patients were designed and tailored specifically for the adult heart.
Wagner, associate professor in Emory’s School of Medicine, and her research team will examine the physiological properties of human heart tissue from pediatric patients. The samples are tissue that needs to be removed as part of the surgical repair of the patientâ€™s heart and would otherwise be discarded.
The ultimate goal of Wagnerâ€™s research is to examine the differences in the human heart in the first year after birth and identify novel target therapies for the pediatric cardiac patient.
Wagnerâ€™s research labs are housed at The Emory-Childrenâ€™s Center, a joint venture between Emory Healthcare and Childrenâ€™s Healthcare of Atlanta.