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Kcentra Approved for Urgent Reversal of Anticoagulation in Adults With Major Bleeding

The U.S. Food and Drug Administration today approved Kcentra (Prothrombin Complex Concentrate, Human) for the urgent reversal of vitamin K antagonist (VKA) anticoagulation in adults with acute major bleeding. Plasma is the only other product approved for this use in the United States. Patients receiving chronic anticoagulation therapy with warfarin and other VKA anticoagulants to prevent blood clotting in conditions such as atrial fibrillation or the presence of an artificial heart valve sometimes develop acute bleeding. Like plasma, Kcentra is used in conjunction with the administration of vitamin K to reverse the anticoagulation effect and stop the bleeding. Unlike plasma, Kcentra does not require blood group typing or thawing, so it can be administered more quickly than frozen plasma. “The FDA’s approval of this new product gives physicians a choice when deciding how to treat patients requiring urgent reversal of VKA anticoagulation,” said Karen Midthun, M.D., director, Center for Biologics Evaluation and Research, FDA. “Kcentra is administered in a significantly lower volume than plasma at recommended doses, providing an alternative for those patients who may not tolerate the volume of plasma required to reverse VKA anticoagulation.” Kcentra is associated with the occurrence of blood clots when used as indicated, and carries a boxed warning regarding the risk of blood clots. The warning also explains that patients receiving Kcentra should be monitored for signs and symptoms of thromboembolic events, as both fatal and non-fatal arterial and venous thromboembolic complications have been reported in clinical trials and post marketing surveillance. Kcentra is made from the pooled plasma of healthy donors. It is processed in a way to minimize the risk of...

Business of Medicine Update

Physician’s Weekly is proud to present this monograph on the business of medicine. Created with the assistance of key opinion leaders and experts in the field, these features explore the challenges and opportunities occurring in an evolving healthcare environment. Physician’s Weekly will continue to feature topics that affect medical professionals beyond the realm of patient care in upcoming months. We welcome your feedback and opinions. Please send comments to keithd@physweekly.com. Thanks for...
2013 National Asthma & Allergy Awareness Month

2013 National Asthma & Allergy Awareness Month

Every year, the Asthma and Allergy Foundation of America (AAFA) declares May to be National Asthma and Allergy Awareness Month. May is peak season for asthma and allergy sufferers and a perfect time to educate your patients who suffer from one of these conditions. Download our free patient education brochure on Asthma, a brochure written by practicing physicians at Harvard Medical School. Also, please read our related features interviewing key opinion leaders in the field: Guidelines for Work-Exacerbated Asthma Getting a Grip on Asthma Control, Severity, & Exacerbations ED Crowding: The Impact on Child Asthma...
Coming to a Consensus on TAVR

Coming to a Consensus on TAVR

In 2011, the FDA approved transcatheter aortic valve replacement (TAVR) for transfemoral use in symptomatic patients with severe aortic stenosis who are not considered candidates for surgery. On behalf of the Society for Cardiovascular Angiography and Interventions, the American College of Cardiology Foundation, the American Association for Thoracic Surgery, and the Society of Thoracic Surgeons, my colleagues and I collaborated to develop an expert consensus document on TAVR. The document, published in a 2012 issue of Journal of the American College of Cardiology, is intended to inform physicians on the most appropriate use of TAVR based on available evidence. The consensus document does not recommend universal use of TAVR because the technology is still being investigated. Instead, we recommend that hospitals eligible to perform TAVR should initially be limited to those that are currently performing an average of at least one aortic valve replacement per week. This means that the 400 busiest cardiac surgery programs would be able to access this technology in the first 2 years following FDA approval. After monitoring outcomes, use of TAVR could be expanded or restricted depending on success and failure rates. A Team Approach to TAVR It’s recommended that territorial and specialty-based decisions on treatment with TAVR be avoided by utilizing a heart team approach. This team should include a surgeon, interventional cardiologist, cardiac anesthesiologist, and an imaging specialist. Allied health professionals—including social workers, nutritionists, and physician assistants— should also be involved. Data from the PARTNER trial, which was the initial regulatory trial for TAVR conducted in the United States, indicate that use of heart team approaches may enhance outcomes. “It’s recommended that...

Key Factors in Weight Gain After Pediatric Tonsillectomy

Studies have indicated that adenotonsillectomy may be associated with significant weight gain after surgery, a problem that can be concerning for both parents and patients. Previous research also suggests that the postoperative weight gain associated with adenotonsillectomy occurs mostly in children who undergo the procedure as treatment for diagnosed obstructive sleep apnea (OSA). “Potentially worrisome weight gains following adenotonsillectomy occurred primarily in children under the age of 6 years who were underweight or normal weight to begin with.” At the 2012 annual meeting of the American Academy of Otolaryngology–Head and Neck Surgeons, my colleagues and I presented data from a study involving a large population of children undergoing adenotonsillectomy and the demographic factors that may contribute to weight gain. We analyzed medical records of children aged 6 months to 18 years who had their tonsils removed between 2008 and 2011. These data were then refined to only include medical records for children who were routinely examined for at least 6 months after their surgery and had recorded height and weight measurements. All patients in the study had a history of OSA or recurrent tonsillitis. Who’s At Risk for Weight Gain? Results of our analysis showed that, on average, patients had a weight gain of 0.5 to 2.0 lbs— equivalent to a 0.4- to 0.6-point increase in BMI scores—after their surgery. Importantly, the gains that were observed were not dependent on whether the children had OSA or recurrent tonsillitis. In a multiple linear regression analysis that controlled for gender and height, only age was significantly and negatively associated with changes in BMI. Potentially worrisome weight gains following adenotonsillectomy occurred primarily...

Making the Case for Early Palliative Care

Throughout the United States, palliative care (PC) is becoming a more established and integral component of comprehensive cancer care for patients with advanced disease. “Published research has shown that PC is associated with better quality of life and mood, improved symptom control, and more appropriate health resource use,” explains Jennifer S. Temel, MD. “It has also been linked to increased patient and caregiver satisfaction, healthcare savings, and survival.” Clinical guidelines recommend that all patients with metastatic cancer be offered PC services early in the course of the disease. Currently, many cancer centers have some form of PC services, such as inpatient consultative services and acute inpatient units. PC clinics, on the other hand, are scarcer entities. Recent analyses have suggested that integrating PC early in the ambulatory care setting is feasible and can improve patient-reported outcomes as well as several key measures of quality end-of-life care and resource use. Early integration of PC with cancer care improves patients’ understanding of their disease and prognosis, leads to more timely transitions to hospice care, and decreases chemotherapy use near the end of life. Looking Closer at Early Palliative Care According to Dr. Temel, more information about the nature and elements of early PC in ambulatory care is needed. “The integration of PC with standard oncologic care may have a different emphasis and focus than traditional inpatient or consultative PC,” she says. Earlier and longer collaborative relationships between PC clinicians and patients may allow the time and opportunity to face complex issues like treatment decisions and advanced care planning rather than focus mostly on acute symptom management and imminent death. A study...

Why I Left Academic Medicine

A medical student who thinks he wants a career in academic surgery asks, “You were deep into academic medicine and walked away from chairman, program director, etc. Why?” [Background: For over 23 years, I was a full-time surgical chairman and residency program director in three different community hospitals affiliated with medical schools.] Good question. For many years I had always said something like: “No matter what crisis happens with the residents or the chairman’s job, it pales in comparison to having a patient with a complication.” In other words, nonclinical problems were annoying but manageable. Then one day I realized that was no longer so. Patients with complications still caused me many sleepless nights, and that hadn’t changed. What had changed was that resident issues and administrative hassles finally became intolerable. The rules set by the accrediting bodies, the ACGME and the Residency Review Committee (RRC) for Surgery, had always been difficult to comply with, especially for a small program. They became more onerous every year or 2 until it reached the point where I can’t imagine how anyone can stand it. Residents can complain to the RRC anonymously and no matter how factually you refute the complaint, the RRC always believes the disgruntled resident. Add in the work hours rules and the lack of motivation of some of today’s med school graduates and I had had enough. The position of surgical chairman in a community teaching hospital is like that of a football referee. At any given time, half your constituency is not happy with you. The administration pays your salary and expects you to spout the party...
Guidance for CRC Screening

Guidance for CRC Screening

Colorectal cancer (CRC) has been the subject of screening guidelines from multiple organizations, creating some confusion among caregivers over which has the highest-quality, evidence-based recommendations. Rather than developing an additional guideline on the topic, the American College of Physicians recently decided that it would be more valuable to provide information to clinicians based on a rigorous review of currently available guidelines. Making Sense of CRC Literature My colleagues and I developed this guidance statement using current recommendations from a joint guideline from the American Cancer Society, the U.S. Multi-Society Task Force on Colorectal Cancer, and the American College of Radiology, as well as individual guidelines from the Institute for Clinical Systems Improvement, the U.S. Preventive Services Task Force, and the American College of Radiology. Based on our evaluations, we developed four guidance statements for CRC screening: 1. Clinicians should perform individualized assessment of risk for CRC in all adults. 2. Clinicians should screen for CRC in average-risk adults starting at age 50 and in high-risk adults starting at age 40 or 10 years younger than the age at which the youngest affected relative was diagnosed with CRC. 3. Clinicians should use a stool-based test, flexible sigmoidoscopy, or optical colonoscopy as a screening test in average-risk patients. Optical colonoscopy should be used in high-risk patients. Clinicians should select the test based on the benefits and harms of the test, availability of the test, and patient preferences. 4. Clinicians should stop screening for CRC in adults older than age 75 or in adults with a life expectancy of less than 10 years. The evidence reviewed in our guidance statement showed that...
2013 Physician Compensation Report: Salaries on the Rise

2013 Physician Compensation Report: Salaries on the Rise

Nearly 22,000 physicians across 25 specialty areas participated in Medscape’s third physician compensation report just released. Overall, it appears that physicians’ income is on the rise. This year’s 3 top-earning specialties – orthopedics, cardiology, and radiology – remain the same, although radiology was bumped from being tied for the number-one spot in 2012 to number three: On the opposite end of the scale, pediatrics was replaced as the lowest paid specialty by HIV/ID. Mean compensation for about one-third (8) of the specialties surveyed topped $300,000 annually. Other highlights from the report include: Orthopedic surgeons showed the highest increase. Endocrinologists and oncologists noted a slight decline. Overall, male physicians earn 30% more than women (17% more in primary care). Those with board certification earned significantly more than those without it ($150,000 vs $251,000). The percentage of physicians involved in Accountable Care Organizations increased significantly from 2012, from 8% to 24%. Physicians in the North Central region of the country earn the most ($259,000), while those in the Northeast Region earn the least ($228,000). Compared with 2012, compensation for physicians in solo practice declined ($216,000 vs $220,000), while that of physician employees increased ($220,000 vs $194,000). Click here to view the full Physician Compensation 2013 report by...
2013 Physician Compensation Report: Salaries on the Rise

2013 Physician Compensation Report: Salaries on the Rise

Nearly 22,000 physicians across 25 specialty areas participated in Medscape’s third physician compensation report just released. Overall, it appears that physicians’ income is on the rise. This year’s 3 top-earning specialties – orthopedics, cardiology, and radiology – remain the same, although radiology was bumped from being tied for the number-one spot in 2012 to number three: On the opposite end of the scale, pediatrics was replaced as the lowest paid specialty by HIV/ID. Mean compensation for about one-third (8) of the specialties surveyed topped $300,000 annually. Other highlights from the report include: Orthopedic surgeons showed the highest increase. Endocrinologists and oncologists noted a slight decline. Overall, male physicians earn 30% more than women (17% more in primary care). Those with board certification earned significantly more than those without it ($150,000 vs $251,000). The percentage of physicians involved in Accountable Care Organizations increased significantly from 2012, from 8% to 24%. Physicians in the North Central region of the country earn the most ($259,000), while those in the Northeast Region earn the least ($228,000). Compared with 2012, compensation for physicians in solo practice declined ($216,000 vs $220,000), while that of physician employees increased ($220,000 vs $194,000). Click here to view the full Physician Compensation 2013 report by...

Reducing Bacteremia in Critically Ill Children

The incidence of bacteremia appears to be lower among critically ill children who receive daily chlorhexidine gluconate (CHG) bathing when compared with those who receive standard bathing. An analysis of nearly 5,000 pediatric ICU admissions demonstrated that the incidence of bacteremia was lower with CHG when compared with standard practices in both intention-to-treat and per-protocol analyses. No serious study-related adverse events were recorded. Abstract: Lancet, January 28, 2013...

Early ED Readmissions After Acute Care Discharge

ED visits within 30 days appear to be common after discharge from acute care hospitals, according to an analysis of adults in the United States. Such visits accounted for nearly 40% of post-discharge hospital-based acute care visits. For every 1,000 discharges, there were 97.5 ED treat-and-release visits and 147.6 hospital readmissions within 30 days. The authors recommend that efforts to improve care transitions focus on ED visits, not just readmissions. Abstract: JAMA, January 23,...

Predicting Cognitive Recovery After Cardiac Surgery

Duke University researchers have found that several factors appear to significantly predict cognitive recovery following cardiac surgery. These included: More patient education. Baseline cognitive index. Less CI decline at 6 weeks. More activities of daily living (ADLs) at 6 weeks. The research team suggests that the link between cognitive recovery and ADLs be explored further because it was a potentially modifiable predictor. Abstract: Anesthesia & Analgesia, February...

Trends in Inpatient Bariatric Surgery for Adolescents

The rate of inpatient bariatric procedures among adolescents appears to have plateaued since 2003, despite the worsening childhood obesity epidemic. The rate of these procedures per 100,000 increased from 0.8 in 2000 to 2.3 in 2003, but was 2.2 in 2006 and 2.4 in 2009. By 2009, about one-third of all surgeries were laparoscopic adjustable gastric banding. Between 2003 and 2009, complication rates remained low and lengths of stay decreased by approximately 1 day. Abstract: Archives of Pediatric & Adolescent Medicine, December 17, 2012...

Long-Term Weight Loss After Bariatric Surgery

Australian researchers have found that durable weight loss can be maintained through 15 years among patients who undergo laparoscopic adjustable gastric banding. Weight loss rates beyond 10 years were similar between patients who required revision procedures and those who did not. Abstract: Annals of Surgery, January...

Assessing Survival in People With Diabetes & Pancreatic Cancer

Long-term, pre-existing type 2 diabetes appears to increase mortality risk among patients diagnosed with pancreatic cancer, according to a study from the University of Pennsylvania. Investigators found that pancreatic cancer patients who had type 2 diabetes for more than 5 years were significantly more likely to die (hazard ratio, 1.16) when compared with people who did not have pre-existing diabetes. Abstract: Cancer, January 15,...

Medications Helpful in High-Risk Patients Without Heart Failure

ACE inhibitors and angiotension II receptor blockers (ARBs) appear to reduce the risk of cardiovascular death, myocardial infarction, and stroke in patients at high cardiovascular risk but without heart failure, according to Italian research. When compared with placebo, ACE inhibitors and ARBs had odds ratios of 0.830 and 0.920, respectively, for risk of these outcomes. Abstract: Journal of the American College of Cardiology, January 15,...

ED Visits in ADHD Patients Using Stimulants

A report from the Substance Abuse and Mental Health Services Administration indicates that the number of ED visits involving ADHD stimulants increased from 13,379 to 31,244 between 2005 and 2010. The report noted that no significant increases in such visits were observed among children younger than 18. ED visits among patients taking ADHD stimulants for non-medical use increased from 5,212 to 15,585 during the study timeframe. Other pharmaceuticals were involved in 45% of visits and illicit drugs and alcohol were involved in about 20% of visits. Abstract: Substance Abuse and Mental Health Services...

Enhancing Outcomes in COPD Patients Undergoing CABG

The use of β-blockers appears to be safe and significantly improves survival at mid-term follow-up among patients with COPD who are undergoing CABG. A comparison study showed that patients receiving β-blockers had a mortality rate of 7.7%, compared with an 18.3% rate for those who did not. Rates of COPD exacerbation were similar for both groups. Abstract: Annals of Thoracic Surgery, February...

Micropauses Reduce Impact of Surgeon Fatigue

An experimental study has found that using micropauses—20-second breaks every 20 minutes—appears to completely or almost completely prevent surgeon muscular fatigue. The authors noted that recent reports have suggested that prolonged surgical procedures can directly affect comfort and surgical accuracy among surgeons. Abstract: Annals of Surgery, February...
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