BY MIRIAM E. TUCKER
Elsevier Global Medical News
Breaking News

PHOENIX (EGMN) – Giving smokers a higher, short-course dose of erlotinib before definitive surgery for squamous cell carcinoma of the head and neck resulted in favorable responses for the first patients evaluated in a small pilot study.

Investigators gave 300 mg of erlotinib (Tarceva) to smokers daily and 150 mg daily to nonsmokers who had a waiting period of more than 14 days before scheduled surgery for head and neck cancer. Seven of the 10 patients evaluated so far had partial responses and 3 had stable disease, according to a poster presented at a head and neck cancer symposium sponsored by the American Society for Radiation Oncology.

The study was based on recent data in non–small cell lung cancer (NSCLC) patients showing that smokers metabolize erlotinib, an epidermal growth factor receptor (EGFR) inhibitor, twice as quickly as do nonsmokers (J. Clin. Oncol. 2009;27:1220-6), said lead author Dr. Mercedes Porosnicu of Wake Forest Baptist Medical Center in Winston Salem, N.C. That study established the maximum tolerated dose of erlotinib at 300 mg daily in NSCLC patients who smoke.

Dr. Poroniscu’s presentation included the case study of a smoker with a very large oral cavity tumor protruding through his lips. He was described as being in significant pain and unable to eat or chew. The first CT scan showed a tumor of at least 8 cm and there was “significant metabolic activity” on PET scan.

“At 6 days of erlotinib treatment, his tumor was obviously smaller and he could chew, eat, and talk. Metabolic activity on PET scan dropped to 44% compared to initial tumor metabolic activity,” Dr. Porosnicu said. “At the end of 14 days’ treatment, his tumor was at least 20% smaller, and he had gained 5 pounds. His surgery wasn’t delayed, and the only treatment-related toxicity was a minimal skin rash.”

A total of 12 patients have been treated to date, for an average of 18.2 days, she reported. Nine were smokers and three were nonsmokers. All patients, smokers and nonsmokers, tolerated the erlotinib dose well with no serious adverse events and no delays in the scheduled time of surgical intervention. There were no grade 3 or 4 toxicities.

Of 10 evaluable patients (including 8 smokers who received 300 mg), 7 (including 5 smokers) showed a partial response, as defined by at least a 20% reduction in maximum tumor diameter. The other three patients (all smokers) showed stable disease. Two of the 12 treated patients received shorter duration treatment but nonetheless displayed good responses.

Interestingly, all four treated female patients (including one smoker) had good responses, independent of the erlotinib dose received, Dr. Porosnicu said.

Early 18[F]-FDG PET scans taken 4-6 days after the start of neoadjuvant erlotinib showed a decrease in metabolic activity of 2% in maximum standardized uptake value (SUVmax) to 98.75% in patients with stable disease and a decrease to 48.06% in patients with partial response.

“Early changes in the PET scan uptake should be further investigated as a marker predictive of response to EGFR inhibition. This pilot trial will continue to enroll patients,” Dr. Porosnicu said.

Erlotinib is approved for indications in non–small cell lung cancer and pancreatic cancer. Head and neck cancer would be an off-label use.

Dr. Porosnicu disclosed that she received financial support for this study from Astellas Pharma.

Subject Codes:
oncology; surgery; otolaryngology;


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January 27, 2012   01:14 PM EST

Mercedes Porosnicu

BY PATRICE WENDLING
Elsevier Global Medical News
Breaking News

LAKE BUENA VISTA, FLA. (EGMN) – The use of transabdominal wall traction to close domain-loss abdomens has avoided the need for skin grafting or a planned ventral hernia, and is now part of the open abdomen protocol at Chicago’s Cook County Hospital.

Transabdominal wall traction (TAWT) uses myofascial cutaneous release via isometric traction to close abdomens in the subset of patients who, after resuscitation and diuresis, cannot be closed, Dr. Andrew Dennis explained at the annual meeting of the Eastern Association for the Surgery of Trauma. This subset of patients is increasing, largely because of the resounding success of damage control laparotomy and decompressive laparotomy.

“TAWT has revolutionized the way we manage domain-loss, open-abdomen patients, and has virtually eliminated the acceptance of planned ventral hernia,” Dr. Dennis said.

Cook County Hospital is one of the nation’s busiest trauma units, with more than 5,000 trauma patients annually. Over a 24-month period, TAWT was used in 28 damage control laparotomy patients and 1 decompressive laparotomy patient who had achieved physiologic steady state and near dry weight, but demonstrated domain loss precluding fascial closure. Their Injury Severity Scores were greater than 30 and their wounds massive at an average width of 18.3 cm (range, 9.5-30 cm) by 30.7 cm in length (range, 12-40 cm).

The technique utilizes an artificial bur (Wittmann Patch) that consists of two biocompatible polymeric sheets linked together via a meshwork of small hooks and loops. To avoid necrosis of the fascial edge, which can occur when the sheets are sewn directly to the fascia, the patch is placed into the abdomen as an underlay, noted Dr. Dennis, a surgeon at the hospital and chair of surgery at Midwestern University in Downers Grove, Ill.

The patch is secured with large braided sutures sewn through all layers of the abdominal wall at the lateral edge of the rectus muscle. Predrilled, 1-inch-wide padded aluminum bolsters are then placed cephalad to caudad over the skin of the anterior abdominal wall, which has been covered with a layer of hydrocolloid dressing for protection.

Adding the aluminum bolsters prevents skin breakdown, erosion of the sutures through the skin, and most importantly, preserves the fascial blood supply and leading fascial edge by sandwiching the abdominal wall between the patch and the bolsters. This disperses medial traction forces throughout all layers of the abdominal wall rather than focusing them on the leading edge of the fascia, as is the case during primary closure.

Domain recovery is achieved by tightening the device approximately 2-4 cm every 48 to 72 hours. When the TAWT and mid-wound distance is less than 2 cm, the system is removed and the abdomen closed primarily with interrupted absorbable suture and an inlay or underlay of bioprosthetic mesh (Gore Bio A).

“TAWT has defeated the surgical myth that domain loss is a nonrecoverable entity,” Dr. Dennis said in an interview. “By treating the muscles of the abdomen as if they are in a state of contracture and shortening, the TAWT device applies concepts learned from the physical medicine literature regarding contractures. That is, by applying constant countertraction to the muscles, in line with the fibers, we are able to lengthen the muscles and thus restore original length.” In the case of the abdomen, this restores the fascial edge to midline and allows for primary closure.

At the time of placement, TAWT decreased the initial defect in the 29 patients by 54% or an average of 9.9 cm. Primary facial closure was achieved in all patients without use of components separation or bridging biologic meshes. The patients returned to the operating room for tightening and wash out of the wound an average of 2.2 times, excluding TAWT insertion and final closure operations, the investigators said.

The average time from initial operation to TAWT placement was 9.5 days, and average time from TAWT placement to primary closure was 9.2 days.

The hospital has been using TAWT for 2 years in its acute trauma population with a near 100% success rate and has begun using it in their chronic giant ventral hernia population, Dr. Dennis said.

“We have brought those patients back, taken down their adhesions and skin grafts, applied the TAWT device in conjunction with our protocol, and subsequently closed all of them,” he said.

Dr. Dennis and his coauthors offered several pearls, including the recommendation that the minimum time for TAWT is 7-10 days, and that extubation should be attempted between tightening operations when possible. The device should be tightened to physiologic tolerance, although intraoperation total paralysis is recommended for maximal tightening.

It is critical to maintain a fenestrated plastic bowel protection barrier extending to all areas of the abdomen in all directions to prevent fusion of the abdominal wall to the viscera. “As long as the two remain independent, then successful domain recapture remains an option,” he said.

TAWT should be continued regardless of the presence of ostomy or enteral leak, which can be controlled with drains. The approach should be aborted, however, if there is no domain recovery and the mid-wound gap remains constant despite multiple attempts at tightening. The maximum number of tightenings in the study was six.

The cohort ranged in age from 16 to 59 years, and 90% were male. In all, there were 20 penetrating traumas, 8 blunt traumas, and 1 emergency surgery for perforated viscus, the authors reported. Fistula was present in four (13%) and an ileostomy or colostomy in seven (24%).

Dr. Dennis and his coauthors reported no financial conflicts of interest.

Subject Codes:
surgery;


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January 26, 2012   11:14 AM EST

BY PATRICE WENDLING
Elsevier Global Medical News
Breaking News

LAKE BUENA VISTA, FLA. (EGMN) – Patients on one of the powerful new oral anticoagulants are left without a good antidote for bleeding if they experience a traumatic injury.

The use of these agents is climbing as baby boomers age and the number of patients with atrial fibrillation continues its steady rise from 2.0 million in 1995 to a projected 4.34 million by 2030.

“If you think it’s an epidemic now, it will become even more so in the coming years,” Dr. Mark Cipolle, medical director of trauma and neurocritical care at Christiana Care Health System in Wilmington, Del., said at the annual meeting of the Eastern Association for the Surgery of Trauma.

Currently, no specific antidote is available for dabigatran (Pradaxa) or the factor Xa inhibitor rivaroxaban (Xarelto), both of which are approved for stroke prevention in nonvalvular atrial fibrillation and for deep vein thrombosis following hip or knee replacement surgery.

The oral Xa inhibitor apixaban (Eliquis) is under priority review for stroke and DVT prevention in atrial fibrillation and will likely move, sans antidote, into the marketplace later this year based on robust results from the recent ARISTOTLE trial.

Vitamin K and protamine sulfate are not expected to affect the anticoagulant activity of the new oral anticoagulants. Some centers have had anectodal success in reversing dabigatran with activated prothrombin complex concentrates (aPCCs), but this has not been widely adopted, according to Dr. Cipolle.

“Some of my colleagues in pharmacy think this may be the drug to help us reverse dabigatran ... but our blood bank hematologists aren’t thrilled about going to this because of the development of antibodies for the new agents,” he said.

The two aPCCs available in the United States are factor eight inhibitor binding activity (FEIBA) and anti-inhibitor coagulant complex, heat treated (Autoplex T); both are indicated for bypass therapy in patients with acquired inhibitors and contain the coagulation factors II, VII, IX, and X.

One of the first randomized trials to look at a specific PCC (Cofact) showed that a single bolus immediately and completely reversed the anticoagulation effect of rivaroxaban in 12 healthy volunteers who were taking 20 mg twice daily, but the PCC had no influence on the effect of dabigatran 150 mg twice daily (Circulation 2011;124:1573-9), said copanelist John Gallagher, clinical nurse specialist for the surgical/trauma ICU at the Hospital of the University of Pennsylvania in Philadelphia.

Recombinant activated factor VIIa has been widely studied in trauma, but not for this specific indication. Early research on antibody monoclonal development is showing promise, Dr. Cipolle said. A recent study described a monoclonal mouse antibody with a high and specific affinity to inhibit dabigatran in both human plasma and whole blood and in a rat in vivo model (J. Am. Coll. Cardiol. 2011;57:E1130).

The package insert for dabigatran recommends emergency dialysis as a reversal strategy, stating that about 60% of dabigatran is removed over 2-3 hours. “This [strategy] may work,” said Dr. Cipolle, observing that about 80% of dabigatran is renally excreted, compared with 66% of rivaroxaban and only 25% of apixaban.

Although not trivial, the half-lives of dabigatran (14-17 hours), rivaroxaban (9 hours), and apixaban (9-14 hours) are shorter than that of warfarin (40 hours), which means that “if you can wait and just not give them the drug, you are probably going to be okay,” he said.

Dr. Cipolle cautioned, however, that reversal of labs may not indicate loss of anticoagulant effects. Also, clotting factors and continued prolongation of anticoagulation assays do not indicate lack of effect.

“The drug industry has spent years developing a drug that we could take orally that you don’t have to measure, and all we want to do is measure it,” he said. “We would like to know just how much anticoagulant effect is present, and if our reversal strategies are working.

“A normal PTT [partial thromboplastin time] is very helpful, but other than that, the classic anticoagulation studies aren’t terribly helpful.”

This point was also referenced in a recent letter to the New England Journal of Medicine penned by two trauma surgeons and an emergency physician who treated several injured patients on dabigatran, all of whom had poor outcomes (N. Engl. J. Med. 2011;365:2039-40). Although their values for activated clotting time on rapid thromboelastography (rTEG) were grossly abnormal at the time of admission, all of the patients had normal results on conventional anticoagulation studies.

“Unfortunately, even with the aid of rTEG, supportive care is all that is available in the emergency setting,” wrote the authors, who strongly urged that hemorrhagic complications and death resulting from trauma be included as part of routine surveillance of all newly approved oral anticoagulants. The authors also argued that “the ability to perform rapid dialysis in patients with bleeding whose condition is unstable or in those with large intracranial hemorrhages will present an incredible challenge, even at level 1 trauma centers.”

Both Dr. Cipolle and Mr. Gallagher emphasized that institutions should have a protocol in place for anticoagulant reversal. The protocol should be based on evidence and practice guidelines, be transparent and modifiable, and identify specific anticoagulant agents, triggers for reversal such as intracranial hemorrhage or solid organ injury, and reversal strategies and methods for monitoring both the use of anticoagulants and reversal strategies, Mr. Gallagher said.

During a discussion of the study, attendees asked how to address anticoagulation at discharge in, for example, a 72-year-old man with early Alzheimer’s disease and a fourth admission for a fall. Dr. Cipolle replied that a recommendation would be placed in his chart based on his initial risk and that a hospitalist or cardiologist would also be called in. He observed that trauma surgeons typically overestimate the fall risk, compared with the stroke risk, and often feel that making such a recommendation may be out of their purview.

Audience member Dr. Ronald Gross, chief of trauma and emergency surgery at Baystate Medical Center in Springfield, Mass., said trauma surgeons need to play a more active role in anticoagulation. He added that physicians at his center have a conversation prior to discharge with every single fall patient about the risks and benefits of anticoagulation, and also contact their prescribing physicians.

Session moderator Dr. Lewis Kaplan, a trauma and critical care surgeon at Yale University, New Haven, Conn., said the nurse practitioners at his center call primary care physicians when trauma patients are admitted and make a follow-up call upon discharge. The trauma surgeon makes an anticoagulation recommendation at discharge, although half the time, despite the conversation, patients are back on their anticoagulants in a matter of weeks, Dr. Kaplan said.

Dr. Cipolle and Mr. Gallagher reported no conflicts of interest. Dr. Lewis serves as a consultant to Pfizer.

Subject Codes:
cardiology; surgery; emergency_trauma; gerontology;


http://www.imng.com


January 26, 2012   09:40 AM EST

Dr. Lewis Kaplan

BY ALICIA AULT
Elsevier Global Medical News
Breaking News

Although the Republican primaries this year have been anything but predictable, one thing is fairly certain: Health care issues will play a more prominent role in the Florida primary on Jan. 31 than they have so far.

Florida is a coveted win for the GOP contenders in part because 50 delegates are at stake, but also because the state is more diverse – racially, ethnically, and politically – than Iowa, New Hampshire, and South Carolina, where primaries have already been held. As such, it’s considered a better reflection of the general election.

With its large elderly population and hard-hit economy, social welfare programs like Social Security, Medicare, and Medicaid are very important to Florida voters.

“Medicare is certainly the third rail in Florida among the sizeable senior population, but so too is Medicaid,” said Daniel A. Smith, Ph.D., professor of political science at the University of Florida, Gainesville.

Many seniors depend on both Medicare and Medicaid for their health care needs: Medicare for basic doctor and hospital care and Medicaid for long-term care, Dr. Smith pointed out.

That means Republican candidates should consider treading lightly when they talk about Social Security, Medicare, or Medicaid, he said, noting that in 1992, Ross Perot’s presidential bid was derailed in Florida after he said he would favor having wealthier Americans pay more for Social Security and Medicare.

“Retirees aren’t interested in dismantling the welfare state,” Mr. Smith said. “Even those Floridians of means are not interested in having their benefits cut.”

Health Care Platforms

At the Republican debate in Tampa on Jan. 23, Rick Santorum went after putative front-runner Mitt Romney for creating what he called a “government-run” health care plan when Mr. Romney was governor of Massachusetts. Mr. Santorum, a former senator from Pennsylvania, called that plan “RomneyCare,” a play on the dismissive “Obamacare” moniker that Republicans have given to the Affordable Care Act.

In the past, Mr. Santorum, who at press time was polling a distant third in Florida, has supported a plan by Rep. Paul Ryan (R-Wisc.) to essentially privatize Medicare. On his official campaign website, he says his first priority as President would be to repeal the Affordable Care Act. He also has said he would encourage the purchase of health insurance across state lines, push for block grants to states for Medicaid, and bolster health savings accounts. Mr. Santorum also backs medical liability reform.

Like Mr. Santorum, Newt Gingrich is calling for more competition in health care, block grants for Medicaid, and a repeal of the ACA. But the former Speaker of the House presents a more detailed plan for health care that includes reforming the Food and Drug Administration, investing more in health research, and putting a premium on quality of care.

Mr. Gingrich and Mr. Romney have traded the lead in Florida for the last several months, with Mr. Romney leading fairly broadly before the South Carolina primary on Jan. 21. Then, just as Mr. Romney won New Hampshire, Mr. Santorum was belatedly declared the winner in Iowa. Mr. Gingrich handily beat Mr. Romney in South Carolina, 40% to 28%.

According to the University of Florida’s Dr. Smith, Mr. Romney has actively courted health care executives in Florida. But it may not be enough to fend off continued brickbats thrown at him for the Massachusetts plan. He has repeatedly disavowed the notion that the plan was the model for the Affordable Care Act. On his website he says his first priority will be a repeal of Obamacare. Mr. Romney, like the other candidates, says he supports less regulation, more competition, and medical liability reform.

Although his platform makes no overt mention of Medicare, analysis by the Center on Budget and Policy Priorities noted that, if enacted, Mr. Romney’s proposal to cap total spending and balance the budget would lead to a 17%-24% cut to Medicare by 2016.

Interestingly, the American Federation of State, County and Municipal Employees has purchased air time in Florida to attack Mr. Romney for what it calls “Medicare fraud.”

The 30-second spot says that, while Mr. Romney worked for the Damon Corp., the company defrauded Medicare. The spot then goes on to morph Mr. Romney’s face into that of Florida Governor Rick Scott’s, with the tag line, “Sound familiar?”

Gov. Scott, a Republican, was the CEO of HCA (then called Columbia/HCA) during a period when the company was found guilty of defrauding Medicare. He was forced to resign and the company paid a record fine to the government. Gov. Scott has seen his approval ratings in Florida bottom out, in part because he proposed to finance public education through reductions in Medicaid payments to hospitals.

Gov. Scott has not endorsed any of the GOP candidates. “He knows that his poll numbers are quite toxic. As a result I don’t think his endorsement behooves anyone right now,” Dr. Smith said.

The Doctors Stand Clear

Several major physicians’ organizations have so far demurred on endorsing any of the candidates. A spokesperson said that the Florida Medical Association did not feel it was appropriate to even comment on a potential endorsement, given that its membership holds a variety of views.

Dr. John A. Gross, a member of the board of the Florida Academy of Family Physicians (that state’s chapter of the American Academy of Family Physicians), said that the FAFP would not be endorsing any candidates at this time either.

The FAFP is “looking for candidates that are willing to stand up for the patient,” said Dr. Gross, who chairs the group’s government relations committee. Family physicians would be interested in candidates who support the patient-centered medical home and new models that provide high quality care.

Tort reform also is a huge issue for Florida physicians, Dr. Gross noted. In a recent poll, physicians in the state estimated that 1 of every 3 health care dollars in Florida is spent on so-called defensive medical costs. The poll was conducted by Patients for Fair Compensation, a nonprofit established by the for-profit physician staffing company Jackson Healthcare.

Dr. Gross said that medical liability reform is a priority issue for the FAFP every year.

The latest bill to address tort reform was introduced in mid-January in the Florida House and Senate.

Abortion is also a hot-button issue in Florida. The state is regarded as anti-choice by NARAL Pro-Choice America.

Mr. Santorum describes himself as strongly pro-life. Mr. Gingrich has said he supports ending federal subsidies for abortion and defunding Planned Parenthood. Mr. Romney had a much-publicized change in position, seemingly going from supporting a woman’s right to choose to being against abortion. He does not have an official stance listed on his campaign website.

This is the first in a series of articles looking at the Republican presidential primaries through the eyes of physicians. Next up: The race moves on to Minnesota and Colorado, which hold their primaries Feb. 7.

Subject Codes:
nephrology_urology; infectious; top_stories; sports; ophthalmology; gastroenterology; mental_health; diabetes; dermatology; orthopaedics; pediatrics; general_primary; oncology; endocrinology; womens_health; pain; allergy; pulmonology; cardiology; rheumatology; surgery; otolaryngology; neurology; emergency_trauma; gerontology;


http://www.imng.com


January 25, 2012   03:19 PM EST

With Florida’s large elderly population and hard-hit economy, health care issues should play a prominent role in the Republican primary on Jan. 31.

Elsevier Global Medical News

A story titled “New Certification for Complex Surgical Oncology,” published January 19, 2012, misidentified the organization that approved the subspecialty certification in complex general surgical oncology. The American Board of Medical Specialties approved the certification program. The program’s training requirements have not yet been approved by the Accreditation Council of Graduate Medical Education (ACGME). The role of the ACGME in administering program examinations was misstated; the American Board of Surgery will administer these exams.

Subject Codes:
oncology; surgery;


http://www.imng.com


January 23, 2012   03:13 PM EST

BY FRANCES CORREA
Elsevier Global Medical News
Breaking News

A new subspecialty certification in complex general surgical oncology aims to provide surgeons with training in the diagnosis, treatment, and rehabilitation of patients with complex cancers such as sarcoma, melanoma, and esophageal malignancies – and hopefully will attract surgeons who want to focus on research.

“The idea is to build leaders in cancer research,” said Christine Shiffer, spokesperson for the American Board of Surgery (ABS). The certification program was created by the ABS and approved by the Accreditation Council for Graduate Medical Education (ACGME) in March.

Ms. Shiffer noted that the majority of oncology cases are – and will continue to be – treated by general surgeons trained in surgical oncology.

Some surgeons say the certification simply solidifies the training qualifications that surgical oncologists already have.

“Trained surgical oncologists are already available to provide care for complex general surgical oncology,” said Dr. Stephen Edge, chair of the Commission on Cancer for the American College of Surgeons (ACS). “The SSO is taking it to the next level for the future. That’s good for surgeons. That’s good for the American College of Surgeons and, most importantly, that’s good for the American public.”

Dr. Edge added that the public will benefit from the assurance that their doctor has the training and credentials to provide the best care possible.

The certification will have minimal impact on general surgeons currently treating the same conditions, said Dr. Fabrizio Michelassi, chair of the ABS Surgical Oncology Advisory Council.

“As current [Society for Surgical Oncology]–approved fellowships graduate only 50 surgical oncologists each year, the number of surgeons who will be eligible for this certificate is relatively small,” Dr. Michelassi said in a statement.

The ABS decided against grandfathering surgeons who have already completed a fellowship in surgical oncology or general surgeons who perform oncologic surgery.

Newly trained surgeons should see the new certification program as an opportunity but not a necessity, said Dr. Patricia L. Turner, a general surgeon and director of member services at ACS. However, she added that the certification could eventually carry a greater marketing advantage for new surgical oncologists. When this process is rolled out, among trainees who finish the same fellowship 1 year apart (and have identical training), one would carry the certificate and the other wouldn’t, she explained.

While program development is underway, there is still work to be done. First, the ACGME will have to approve their training requirements, which the ABS expects to see by June. Once requirements are approved, the written and oral examinations can be finalized.

Existing surgical oncology training programs can become ACGME accredited to provide the training and administer the examinations. The first examinations are expected to start in the fall of 2012, at the earliest, according to the ABS.

Subject Codes:
oncology; surgery;


http://www.imng.com


January 19, 2012   10:30 AM EST

BY MICHELE G. SULLIVAN
Elsevier Global Medical News
Breaking News

An hour of intravenous anesthetic during surgery can shave a day off the hospital stay and decrease the risk of postoperative complications for some patients, according to Dr. Marcel Durieux.

Intravenous anesthetics (for example, lidocaine) exert surprising effects on recovery from some – but not all – major abdominal surgeries. They’re associated with decreased postoperative pain, quicker return of bowel function, and a shorter length of stay. But they don’t help in all surgeries – not even in all abdominal surgeries – and the way they work is still something of a mystery, he said.

The well-documented systemic benefits of surgical epidurals got anesthesiologists thinking about intravenous agents, said Dr. Durieux, professor of anesthesiology at the University of Virginia, Charlottesville. Epidurals provide excellent postoperative pain control, but it was obvious that their effects spread much farther.

“They do much more than just help pain,” he said in an interview. “They have significant effects on surgical outcomes that can’t be explained simply by blocking sodium channels in nerves.”

Because the effects span several systems, they are probably due to systemic absorption of the anesthetic agent, he said. “If improved outcomes have little to do with blocking nerves, there is no special reason to give an anesthetic near those nerves. You should be able to give it intravenously at doses that lead to blood levels similar to what we get with an epidural.”

Researchers have been looking at the issue for more than a decade, and are now honing in on inflammation as the root of these postoperative problems.

A hyperinflammatory response to surgical trauma is probably the root of many postoperative problems, including pain and thrombosis, Dr. Durieux said. “The response develops during the case and lasts into the postoperative period. If it continues, it can lead to a lot of negative effects – increased cardiac strain, impaired respiratory function that can lead to respiratory distress syndrome, nausea and ileus, and a procoagulatory state.”

Intravenous local anesthetics seem to suppress that response before it explodes. The drugs likely target neutrophils and the two pathways in which they respond to a bodily injury: priming and activation.

In normal activation, a neutrophil senses bacteria and generates superoxide that kills the invader, leading to the normal inflammatory response seen with an illness. But a wound, including a surgical wound, primes the neutrophils for a superresponse. “Subsequently, when they encounter bacteria, they generate 10 times the amount of superoxide, actually damaging the body,” Dr. Durieux said.

In some yet-unknown way, local anesthetics appear to inhibit neutrophilic priming. “There is no other drug around that selectively blocks priming. And if you don’t prime these neutrophils during surgery, you won’t have them there 2 days after surgery causing problems. Even if the local anesthetic goes away, its beneficial effect does not.”

Recognition of this prolonged anti-inflammatory effect may eventually shape the administration of intraoperative local anesthetics. Because there is no data-driven protocol, some anesthesiologists give the drug for an hour during surgery, some continue it in the recovery room, and a few want to continue it on the surgical floor.

“This is still a matter of debate. Most of the data show that the vast majority of the benefit can be achieved by giving the drug just for the duration of the case. You can leave it on in the recovery room and turn it off when the patient is ready to go to the floor.”

Unfortunately, the agents seem rather selective in their benefit. A 2010 meta-analysis found it most effective in open and laparoscopic bowel surgeries, but unhelpful in small studies on tonsillectomy, arthroscopic surgery, or coronary artery bypass. Another 2010 study found the drugs didn’t have much effect in abdominal hysterectomy, but a 1998 study found it had good effect in prostatectomy.

“I can’t explain that,” Dr. Durieux said. “I’m impressed by the data we have but frustrated that the benefit has been shown in just a subset of surgeries.”

Although more research is necessary – and in the offing – the drugs are cheap, safe, and easy to use.

“But I’m selective in how I use it. If someone is having an open colectomy and faces prolonged painful ileus, I would consider it, for example. And for people who can’t or won’t accept an epidural, I think this is a reasonable way to go.”

He disclosed that he serves on the steering committee of a clinical trial investigating a novel system for delivering local anesthetics to surgical wounds for postoperative pain relief.

Subject Codes:
surgery;


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January 18, 2012   04:03 PM EST

BY MARY ANN MOON
Elsevier Global Medical News
Breaking News

Intravenous cangrelor may prove to be a useful “bridge” in patients awaiting nonemergency CABG who must first discontinue their regular antiplatelet therapy, according to the results of the Maintenance of Platelet Inhibition With Cangrelor (BRIDGE) trialreported in the Jan. 18 issue of JAMA.

The practice of discontinuation of antiplatelet therapy is associated with significant morbidity and mortality; in patients who have coronary stents, it raises the risk of stent thrombosis that often leads to myocardial infarction and death. “Cessation of thienopyridine treatment for nearly a week before surgery, with patients not hospitalized or monitored but carrying an excess risk of major ischemic events, has been a troubling and not infrequent problem for clinicians, because it is estimated that approximately 5% of patients will require some type of surgery within the first 12 months after stent implant or [acute coronary syndrome] diagnosis,” said Dr. Dominick J. Angiolillo of the department of cardiology, University of Florida, Jacksonville, and his associates.

In this multicenter clinical trial sponsored by the drug’s maker, cangrelor “achieved and maintained target levels of platelet inhibition known to be associated with a low risk of thrombotic events compared with placebo, without a significant excess in bleeding complications,” the investigators noted.

Cangrelor is an investigational nonthienopyridine adenosine triphosphate analogue that acts as an antagonist of the P2Y12 receptor. It is characterized by “rapid, potent, predictable, and reversible platelet inhibition,” and its extremely short half-life (3-6 minutes) allows “rapid offset of effect.”

The investigators hypothesized that cangrelor would allow patients who must discontinue antiplatelet therapy prior to cardiac surgery, especially if they’re taking a P2Y12 inhibitor such as ticlopidine, clopidogrel, or prasugrel, to go off their usual drug without raising their risk for thrombotic events. They tested this hypothesis in a two-part trial.

The first part was an open-label dose-finding study involving 11 adults, which concluded that the optimal intravenous dose needed to maintain antiplatelet activity without raising bleeding risks was 0.75 mcg/kg per minute.

In the second part of the trial, 210 patients awaiting CABG at 34 medical centers around the world were randomly assigned to receive either cangrelor (106 subjects) or placebo (104 subjects) after thienopyridines were discontinued and throughout the preoperative period – that is, until 1-6 hours before surgical incision. Platelet function was assessed before, during, and after the infusion.

The mean interval between discontinuation of thienopyridines and infusion of the study drug was 29 hours, and the mean duration of the infusion was approximately 3 days.

The primary end point was the percentage of patients who showed platelet reactivity of less than 240 P2Y12 Reaction Units (PRUs) throughout the infusion of the study drug. “This level approximated the levels of platelet reactivity expected to be maintained if a thienopyridine had not been discontinued,” the investigators explained.

This end point was met by 99% of the cangrelor group but only 19% of the placebo group. It was achieved independently of patients’ usual dose of thienopyridines and independently of the length of time since thienopyridines were discontinued, Dr. Angiolillo and his colleagues said (JAMA 2012;307:265-74).

Moreover, cangrelor did not raise the rate of excessive bleeding related to CABG surgery. This safety end point occurred in 22 patients: 11.8% of the cangrelor group and 10.4% of the placebo group, a nonsignificant difference.

The number of minor bleeding events was numerically higher with cangrelor but did not reach statistical significance. Other adverse events, including dyspnea and laboratory abnormalities, also were comparable between the two groups. This favorable safety profile, even with prolonged infusion of up to 7 days, was “reassuring,” the researchers noted.

Ischemic end points prior to surgery were low in both groups, occurring in 2.8% (3 of 106) and 4.0% (4 of 101) of patients in the cangrelor and placebo groups.

“These observations support the hypothesis that intravenous cangrelor is a feasible management strategy, providing prolonged platelet P2Y12 inhibition in patients who must wait for cardiac surgery after thienopyridine discontinuation,” they said.

This study was sponsored by the Medicines Company. Dr. Angiolillo reported ties to Bristol-Myers Squibb, Sanofi-Aventis, Eli Lilly, Daiichi Sankyo, AstraZeneca, Portola, Novartis, Medicure, Accumetrics, Arena Pharmaceuticals, Merck, Evolva, and Abbott Vascular, and his associates reported ties to numerous other industry sources.

Subject Codes:
top_stories; cardiology; surgery;


http://www.imng.com


January 17, 2012   04:00 PM EST

BY MARY ANN MOON
Elsevier Global Medical News
Breaking News

For the first time, researchers say they have established benchmarks for the rates of in-hospital venous thromboembolism that occur after total or partial hip arthroplasty and after total or partial knee arthroplasty, according to a report Jan. 18 in JAMA.

In a meta-analysis of 47 studies that documented venous thromboembolism (VTE) event rates in nearly 45,000 patients who received recommended prophylaxis during hospitalization for knee or hip arthroplasty, investigators estimated that approximately 1 in every 100 patients undergoing knee arthroplasty and 1 in every 200 undergoing hip arthroplasty will develop symptomatic VTE before they are discharged.

“These estimates are of value to individual patients and clinicians in the consideration of risks and benefits” of the two procedures. They also are important because rates of in-hospital VTE are increasingly used as indicators of patient safety at individual medical centers, even though the expected background rates haven’t been established until now, said Jean-Marie Januel, a registered nurse with the Institute of Social and Preventive Medicine, Lausanne (Switzerland) University Hospital, and his associates.

“Large numbers of patients worldwide undergo hip and knee replacement procedures annually, and VTE is a widely acknowledged complication. Yet no estimate of symptomatic VTE risk prior to hospital discharge is available from the literature that can be conveyed to patients in the informed consent process,” they noted.

Mr. Januel and his colleagues performed a systemic search of the literature to identify studies performed between 1996 and 2011 in which subjects undergoing either hip or knee arthroplasty received VTE prophylaxis according to published guidelines, including either low-molecular-weight heparin or inhibitors of factor Xa or IIa. They found 41 randomized clinical trials and 6 observational studies to include in the meta-analysis.

A total of 22 of the studies were performed in Europe, 14 were in North America, and 11 were in other regions. The mean duration of follow-up after either surgery was 13 days.

This included 21 studies of partial or total hip arthroplasty, 20 of partial or total knee arthroplasty, and 6 studies of both procedures, with a total of 44,844 subjects.

There were 443 cases of symptomatic postoperative VTE that developed before hospital discharge: 288 in the 23,475 knee patients and 155 in the 23,475 hip patients. This included 182 cases of deep vein thrombosis in the knee patients and 93 in the hip patients, as well as 106 cases of pulmonary embolism in the knee patients and 43 in the hip patients.

The pooled incidence rates of VTE were approximately 1% after knee arthroplasty and approximately 0.5% after hip arthroplasty. This means that the background rate of VTE is approximately 1 in 100 knee patients and 1 in 200 hip patients, the investigators said (JAMA 2012;307:294-303).

When the data were broken down by type of VTE, the pooled incidence rates were 0.26% for deep vein thrombosis and 0.14% for pulmonary embolism after knee arthroplasty. The corresponding rates were 0.63% for deep vein thrombosis and 0.27% for pulmonary embolism after hip arthroplasty.

“Given that these rates are based on the results of rigorous studies, they may represent a lower incidence than actual rates observed in clinical practice, in which patients are selected less rigorously and prophylaxis is administered less assiduously,” Mr. Januel and his associates noted.

The pooled incidence rates of deep vein thrombosis were lower for both knee patients and hip patients when factor Xa or IIa inhibitors, rather than low-molecular-weight heparin, were given for prophylaxis. “However, we cannot make assertions regarding comparative efficacy among treatments, because our meta-analysis did not directly compare [these agents] as an efficacy meta-analysis would have done,” they said.

In-Hospital Not as Telling as Post-Discharge VTE Rates

The in-hospital VTE rates reported by Januel et al may be “suboptimal” for assessing both patients’ risks and a facility’s performance in patient safety, as the investigators proposed, said Dr. John A. Heit of the division of cardiovascular diseases at the Mayo Clinic, Rochester, Minn.

The period of VTE risks extends far beyond the hospital stay, with as many as 76% of VTE events occurring during the 3 months following hospital discharge. “From the perspective of the patient contemplating elective total hip replacement or total knee replacement,” the 3-month rate rather than the in-hospital rate of VTE is more important in weighing risks and benefits, he said in an editorial accompanying Mr. Januel’s report (JAMA 2012;307:306-7).

And it can be argued that this cumulative rate of VTE is also more important for the purpose of assessing a facility’s performance, Dr. Heit added.

This study was supported by Alberta Innovates Health Solutions, a government research funding agency, and the International Methodology Consortium for Coded Health Information, a collaboration of health sciences researchers to promote quality of care. Dr. Heit reported ties to Daiichi Sankyo, GTC, Ortho-McNeil-Jansen, the National Heart, Lung, and Blood Institute, the National Human Genome Research Institute, the National Institutes of Health, the Centers for Disease Control and Prevention, and the Mayo Foundation.

Subject Codes:
top_stories; cardiology; rheumatology; surgery; gerontology;


http://www.imng.com


January 17, 2012   04:00 PM EST

BY MITCHEL L. ZOLER
Elsevier Global Medical News
Breaking News

MIAMI BEACH (EGMN) – Local and regional anesthesia are better options than is general anesthesia for patients undergoing endovascular repair of an abdominal aortic aneurysm, based on findings from a registry with nearly 1,200 patients.

Both local anesthesia and regional anesthesia each surpassed general anesthesia in two periprocedural measures: significantly reducing procedure time, and significantly reducing postoperative hospitalization, Dr. Rutger A. Stokmans said at ISET 2012, an international symposium on endovascular therapy.

In addition, both local and regional anesthesia led to trends in reduced rates of major adverse events during the 30 days following surgery, although these differences did not reach statistical significance. All three anesthesia types linked with similar rates of both technical and clinical success of the aneurysm repairs. Regional anesthesia also led to a significantly lower rate of ICU admission, compared with both general and local anesthesia; local anesthesia showed no significant difference for this measure, compared with general anesthesia.

Based on these findings, local or regional anesthesia should be preferred when performing endovascular aneurysm repair (EVAR), whereas general anesthesia should usually be avoided, said Dr. Stokmans, a vascular surgeon at Catharina Hospital in Eindhoven, the Netherlands.

These findings support the most recent anesthesia recommendations of the European Society for Vascular Surgery, which in 2011 guidelines for managing abdominal aortic aneurysms (AAA) cited local anesthesia as preferred for EVAR, with regional or general anesthesia reserved for patients with contraindications for local anesthesia, he said (Euro. J. Vasc. Endovasc. Surg .2011;41[suppl. 1]:S1-S58). The most recent guidelines for AAA management from the Society for Vascular Surgery suggested using local or regional anesthesia over general anesthesia, he added (J. Vasc. Surg. 2009[suppl.]:50:S2-S49).

But despite these recommendations, the most commonly used anesthesia type worldwide for EVAR repair of AAA has been general anesthesia, followed by regional anesthesia, with local treatment used least often, according to the registry data reported by Dr. Stokmans. Among the 1,199 patients enrolled in ENGAGE (Endurant Stent Graft Natural Selection Global Postmarketing Registry) during March 2009 to December 2010 in 30 countries on five continents, 749 (62%) underwent their EVAR with general anesthesia, 325 (27%) with regional, and 125 (10%) with local anesthesia. (Percentages do not add up to 100% because of rounding.)

The registry data also showed striking regional variations in anesthesia use, with general anesthesia used on about 90% of patients in Canada, Australia, and New Zealand, and on about 70% of patients in Scandinavian countries and the United Kingdom. But in Central Europe, regional anesthesia – used on nearly 70% of EVAR patients – dominated. The only region favoring local anesthesia was South America (Argentina, Columbia, and Uruguay), where about 50% of patients received local, but more than 40% received general anesthesia, he said. The registry contained no U.S. patients, although the Endurant AAA stent graft system is marketed in the United States.

The average age of the EVAR patients in the registry was about 73 years. Those patients who underwent general anesthesia were significantly older, by an average of about 18 months, compared with those who received local or regional anesthesia.

The proportions of patients undergoing general, regional, or local anesthesia were similar in the subgroups of patients with American Society of Anesthesiologists (ASA) physical status scores of 1, 2, or 3. However, among the highest-risk patients included in the study – those with an ASA score of 4 – a significantly greater proportion of patients received general anesthesia. The multivariate models used in the analysis, therefore, were adjusted for age and for ASA score. About 42% of patients were in ASA class 2, and another 42% in class 3.

All patients were hemodynamically stable at the time of their enrollment. The maximum AAA diameter of registry patients was 6 cm, and about 88% of patients had an AAA diameter greater than 5 cm.

Average procedure times were 106 minutes in the general anesthesia patients, 95 minutes in the regional patients, and 81 minutes in the local anesthesia patients – statistically significant differences among the three groups.

The average postoperative hospitalization was 5.2 days in the general anesthesia patients, 4.3 days in the regional patients, and 3.6 days in the local anesthesia patients, differences that were statistically significant among each of the three groups.

The rate of technical surgical success was 98% in all three subgroups, and the rate of clinical success reached 97%-98% in all three groups.

The rates of major adverse events during the 30 days following surgery were 5.1% in the general anesthesia patients, 3.2% in the local patients, and 2.2% in the regional anesthesia patients. None of these differences reached statistical significance. Major adverse events included death, MI, stroke, renal failure, blood loss greater than 1 L, and bowel ischemia. No patients developed paraplegia or respiratory failure.

Postoperative ICU admission occurred for 27% of the regional anesthesia patients, 35% of the general patients, and 42% of the local anesthesia patients. The rate among the regional patients was significantly less than in the other two groups, but the difference in rates between the general and local anesthesia patients did not reach statistical significance.

The ENGAGE registry was organized and sponsored by Medtronic, which markets the Endurant stent. Dr. Stokmans and his associates received an unrestricted research grant from Medtronic. Dr. Stokmans said that he had no other disclosures.

Subject Codes:
top_stories; cardiology; surgery;


http://www.imng.com


January 17, 2012   02:17 PM EST

Rutger A. Stokmans

BY MARY ANN MOON
Elsevier Global Medical News
Breaking News

Roux-en-Y gastric bypass surgery resulted in greater, more rapid, and more sustained weight loss compared with gastric banding, but also a higher number of complications in a matched-pair study published online Jan. 16 in Archives of Surgery.

The weight loss advantage achieved with Roux-en-Y leads to better correction of the comorbidities that accompany obesity, such as adverse lipid profiles and high fasting glucose levels, said Dr. Sébastein Romy of the department of visceral surgery, Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland, and his associates.

Although there are more early complications with the Roux-en-Y procedure, they are outweighed by “the much higher long-term major morbidity seen after gastric bypass, leading to a large number of major reoperations and their risks,” the investigators noted.

The sharp rise in bariatric surgeries performed in recent years in the United States has occurred predominantly in gastric banding procedures. “This is probably because gastric banding is perceived both by doctors and patients as a simple, safe, and reversible operation but also because of a huge industry-driven marketing campaign,” they said.

Which surgery is “better” has been contested. To date, among the 17 published studies comparing the two procedures, many have had important methodologic flaws such as small numbers of patients and very limited follow-up.

Dr. Romy and his colleagues performed a matched-pair analysis of patients who underwent the two procedures in 1998-2005. The study subjects, who had failed to lose weight with more conservative approaches, all had a body mass index of 40 or more, or a BMI of 35 plus at least one severe comorbidity. A total of 221 patients who underwent Roux-en-Y gastric bypass were matched for age, sex, and BMI with 221 who underwent gastric banding. Follow-up rates after 6 years were approximately 92% in both groups. The same team performed the operations at the same two hospitals.

Maximal weight loss was achieved at a mean of 18 months after Roux-en-Y gastric bypass, compared with 36 months after gastric banding. The percentage of excess weight lost was significantly higher after Roux-en-Y (78.5%) than after gastric banding (64.8%), and the mean nadir in BMI was significantly lower (26.7 vs. 29.4, respectively). After 6 years, only 5 patients (2.4%) in the Roux-en-Y group had a BMI greater than 40, compared with 21 patients (13.8%) in the gastric banding group.

As a result, significantly more patients who had Roux-en-Y surgery were rated as having excellent or acceptable results at all time points during follow-up, Dr. Romy and his associates said (Arch. Surg. 2012 Jan. 16 [doi:10.1001/archsurg.2011.1708]).

Treatment failures were defined as a weight loss of less than 25% of baseline weight or the need to reverse the surgery or convert to a different bariatric procedure. At the 3-year mark, there were no treatment failures among Roux-en-Y patients, compared with 39 treatment failures (18.2%) among gastric banding patients. After 6 years, failure rates were 2.5% and 38.9%, respectively, in Roux-en-Y and gastric banding patients.

Improvement in lipid profiles was significantly greater after Roux-en-Y than after gastric banding. Total cholesterol, LDL cholesterol, and triglyceride levels decreased after Roux-en-Y but not after gastric banding. Fasting glucose levels also were lower after Roux-en-Y (89.55 mg/dL vs. 92.79 mg/dL).

Quality of life improved in both groups, but the improvement was significantly faster and persisted for a longer time after Roux-en-Y surgery. In particular, Roux-en-Y patients had much better food tolerance, with no worsening after surgery, whereas food tolerance tended to worsen over time after gastric banding.

There were significantly more early complications after Roux-en-Y (17.2%) than after gastric banding (5.4%), which is not surprising given that Roux-en-Y is a more complex operation and requires a longer operative time and longer hospitalization. However, most of these early complications required only conservative treatment, and there was no significant difference between the two groups in early major complications, the researchers said.

In contrast, gastric banding was associated with significantly more long-term complications than was Roux-en-Y (41.6% vs. 19%) and required more than twice as many reoperations (26.7% vs. 12.7%).

“After gastric banding, functional problems like esophageal dilatation (10.4%), impairing reflux requiring (or resistant to) daily high-dose proton-pump inhibitor therapy (6.8%), or severe food intolerance (6.3%) accounted for the majority of long-term complications, together with band erosions (7.7%). Overall, band removal was necessary in 47 patients (21.3%),” they said.

“Long-term complications after Roux-en-Y gastric bypass are essentially limited to anastomotic strictures and bowel obstructions and symptomatic internal hernia.” Most strictures were not considered major complications, requiring only endoscopic dilatation. Although bowel obstruction is potentially life threatening, in most cases it doesn’t jeopardize the bypass or require reversal, Dr. Romy and his colleagues said.

No financial conflicts of interest were reported by the researchers.

Still a Few Caveats

“I personally agree” with Romy et al. that Roux-en-Y gastric bypass is the better procedure, but “before we make from this conclusion a paradigm, a few caveats remain,” Dr. Jacques Himpens said in an invited critique that accompanied Dr. Romy’s report (Arch. Surg. 2012 Jan. 16 [doi:10.1001/archsurg.2011.1855]).

A case-control study such as this one may be biased, said Dr. Himpens of the European School of Laparoscopy at Saint Pierre University Hospital, Brussels. Even though a prospective randomized trial comparing the two surgeries isn’t feasible, a prospective rather than retrospective comparison of matched patients would yield better evidence, as would a multicenter rather than a single-center study, according to Dr. Himpens.

In addition, a growing number of Roux-en-Y patients are showing neuroglycopenia and diabetes recurrence several years after surgery, which is concerning, he said.

Dr. Himpens reported being a consultant for Ethicon Endo-Surgery, Covidien, and Gore.

Subject Codes:
gastroenterology; diabetes; endocrinology; surgery;


http://www.imng.com


January 17, 2012   12:51 PM EST

Elsevier Global Medical News

The article “D-Dimer May Be Marker of VTE Risk” (published Jan. 5, 2012) misstated D-dimer levels. The baseline median D-dimer level was 0.94 mg/L in all patients. The baseline D-dimer level was higher in patients who experienced a primary efficacy outcome event, compared with those who did not have such an event (a median of 1.98 mg/L vs. 0.92 mg/L).

Subject Codes:
cardiology; surgery;


http://www.imng.com


January 13, 2012   02:12 PM EST

BY MIRIAM E. TUCKER
Elsevier Global Medical News
Breaking News

BALTIMORE (EGMN)–No notable increases in new-onset seizure disorder or exacerbations of a pre-existing seizure disorder were seen following gastric bypass surgery in a retrospective case series of more than 1,500 patients from the Mayo Clinic.

Reports of new-onset or exacerbated seizure disorders following Roux-en-Y surgery are often posted on epilepsy patient-oriented Web sites such as epilepsy.com, along with reports of other neurologic complications such as Wernicke-Korsakoff syndrome, polyradiculoneuropathy, myelopathy, and optic neuropathy. However, few previous studies have examined a potential connection between gastric bypass and epilepsy, Dr. Richard S. Clemmons and Gregory D. Cascino said in a poster at the annual meeting of the American Epilepsy Society.

A diagnosis of epilepsy pre-existed prior to Roux-en-Y surgery in 12 of 1,542 patients who were operated on at the Mayo Clinic between September 1997 and September 2007. Those patients were selected from a larger group of 1,776 patients because they had more than 1 year of follow-up, had undergone surgery for morbid obesity, and were aged 18 years or older. Despite evidence that gastric bypass surgery might result in decreased absorption of drugs with high proximal absorption or low pH (Am. J. Health Syst. Pharm. 2006;63:1852-7), 8 of these 12 patients had no decrease in drug levels, based on patient report or on serum testing before and after surgery. One patient who did have a low drug level was suspected of poor compliance. None of the 12 had exacerbations of their seizures.

“Based on the limited data here, there was not a decrease in serum drug levels for valproic acid, carbamazepine, or levetiracetam. ... Even patients with significant seizure risk factors did not manifest an exacerbation of seizures,” noted Dr. Clemmons and Dr. Cascino, both of whom were affiliated with the division of epilepsy in the department of neurology at the Mayo Clinic, Rochester, Minn., at the time of the study. Dr. Clemmons is currently in private practice in Denver.

Only 5 of the 1,542 patients developed new-onset epilepsy following surgery. Of those, only 3 (1.9% of the total cohort) could be considered to have unprovoked epilepsy. One of the other two patients had a history of meningoencephalitis and had just a single seizure 2 years after surgery that was possibly associated with hypoglycemia. The other one had a seizure in the setting of a stroke 3 months after surgery. None of the five developed intractable epilepsy.

About three-fourths of the patients in the study were female. Their charts were examined for evidence of seizure exacerbation post surgery, defined as an increase in seizure frequency above preoperative baseline where another cause was not identified. Patient questionnaires were used to supplement where data were lacking.

“Based on the reviewed data, there is no clear exacerbation of preexisting seizure disorder following gastric bypass ... Most patients with seizure disorder do well following Roux-en-Y,” they concluded.

Dr. Clemmons, who presented the poster at the meeting, stated that he had no financial disclosures.

Subject Codes:
gastroenterology; surgery; neurology;


http://www.imng.com


January 11, 2012   03:55 PM EST

BY DIANA MAHONEY
Elsevier Global Medical News
Breaking News

SAN ANTONIO (EGMN) – Total skin-sparing mastectomy with complete preservation of the breast skin envelope was associated with favorable oncologic and ischemic outcomes in a large, high-risk cohort of women who underwent the procedure over a 10-year period in San Francisco, a study has shown.

The findings suggest that the surgery, which produces superior cosmesis and is associated with a high rate of patient satisfaction, is a reasonable option for many women facing therapeutic or prophylactic mastectomy, Dr. Anne G. Warren Peled said at the San Antonio Breast Cancer Symposium.

The total skin-sparing mastectomy (TSSM) allows preservation of the nipple-areola dermal layer when ductal tissue is removed during mastectomy. “The procedure is increasingly offered to women for both therapeutic and prophylactic indications, and when combined with immediate breast reconstruction, can produce excellent aesthetic results,” explained Dr. Warren Peled, a surgical resident at the University of California, San Francisco.

Because the oncologic safety of the procedure and the potential for higher rates of postoperative complications continue to be debated, Dr. Warren Peled and her colleagues sought to evaluate both outcomes using data collected in a prospectively maintained database. The investigators analyzed patient and tumor characteristics, treatment details, and the development of any postoperative complications, as well as local or distant recurrences, for 428 patients (mean age, 46.9 years) who underwent 657 TSSMs and immediate breast reconstruction at the UCSF Medical Center in 2001-2010.

“The mastectomy incisions included radial, lateral, periareolar, and inframammary incisions, and the areolar and nipple complex tissue was separated from the dermal layer of skin by sharp dissection with inversion of the nipple skin to ensure the removal of all of the nipple duct tissue,” Dr. Warren Peled said during a poster discussion. Of the 657 mastectomies, 412 were therapeutic procedures, and 245 (58 bilateral and 187 contralateral) were prophylactic, she said.

Most of the tumors were stage 0 (111) or stage I (135), although stage II (95), III (48), and IV (7) tumors were also observed, Dr. Warren Peled reported. Some 14 mastectomies were for recurrent cancer, she noted. In addition, 210 patients underwent neoadjuvant chemotherapy, 144 had postmastectomy radiation therapy, and 78 had adjuvant chemotherapy, she said.

With respect to nipple involvement on pathological analysis, 11 specimens had evidence of in situ cancer and 9 had evidence of invasive cancer, leading to re-excision in 7 cases, removal of the nipple-areolar complex (NAC) in 9 cases, and NAC radiation in 4 cases, said Dr. Warren Peled.

The conventional, two-stage, expander-implant method – in which a tissue expander placed under the chest muscle is implanted and gradually inflated to expand the tissue in preparation for the synthetic implant 3-6 months later – was used in 80% of the postmastectomy reconstructions, Dr. Warren Peled said. The remaining 20% of the reconstructions included either the placement of a permanent silicon implant at the time of mastectomy (4.7%) or autologous reconstruction (15.3%), she said.

A review of the oncologic outcomes in the 412 patients who underwent therapeutic mastectomies showed that, at a median follow-up of 28 months, four patients (1%) experienced local recurrence only, eight (1.9%) experienced distant recurrence only, and four experienced both local and distant recurrence (1%), Dr. Warren Peled reported. Among the local recurrences, two each were invasive (0.7%) and in situ cancer (1.8%), and among the distant recurrences, all eight (2.7) were invasive cancers. Among those with both local and distant recurrences, three (1%) and one (0.9%) were invasive and in situ, respectively, she said,

Of the 126 patients who had a minimum 36 months’ follow-up (median, 45 months), 2 patients (1.6%) had local recurrence only, one of which was invasive; 1 patient (0.8%) had distant recurrence only; and 1 (0.8%) had both, Dr. Peled said, noting that the recurrences in the latter two patients were invasive.

An assessment of ischemic complications showed 13 cases (1.9%) of partial nipple loss; 10 cases (1.5%) of complete nipple loss, and 78 cases (11.8%) of skin flap necrosis, Dr. Peled said, noting that the group’s current nipple loss rate is lower than 1%, thanks to serial improvements in surgical technique.

The findings indicate that TSSM “can be performed with low rates of nipple involvement and locoregional recurrence,” Dr. Warren Peled stated. Although the short-term findings are encouraging, the study cannot speak to the long-term oncologic safety of the procedure. “Longer term follow-up is needed to confirm the oncologic safety over time,” she said.

Dr. Warren Peled had no relevant financial conflicts to disclose.

Subject Codes:
oncology; womens_health; surgery;


http://www.imng.com


January 10, 2012   11:46 AM EST

BY MARY ANN MOON
Elsevier Global Medical News
Breaking News

The direct thrombin inhibitor dabigatran appears to raise the risk of myocardial infarction or acute coronary syndromes, according to a meta-analysis of seven randomized clinical trials published online Jan. 9 in the Archives of Internal Medicine.

The meta-analysis included randomized clinical trials assessing the noninferiority of dabigatran against various control treatments including adjusted-dose warfarin, enoxaparin, and placebo, in a broad spectrum of patients using the drug for a variety of indications.

“We used several meta-analytic methods and several association measures, and the results were consistent. Although the relative risk increase was 33%, the absolute risk increase was very small, at 0.27%,” said Dr. Ken Uchino and Dr. Adrian V. Hernandez, both of the Cleveland Clinic.

The mechanism by which dabigatran increases the risk of MI or acute coronary syndrome (ACS) is not yet known. It is possible that the drug doesn’t actively raise this risk, but instead lacks some protective effect that the control treatments possess, the investigators noted.

The meta-analysis covered 30,514 study subjects, including patients with atrial fibrillation who used dabigatran to prevent stroke, patients with atrial fibrillation who used it to prevent acute venous thromboembolism, patients with ACS who used it to prevent recurrent ACS, and patients undergoing joint replacement who used it to prevent deep vein thrombosis.

Overall, patients who received dabigatran were at significantly higher risk of MI or ACS than were control patients. The incidence of these events was 1.19% in those taking dabigatran, compared with 0.79% in control subjects, Dr. Uchino and Dr. Hernandez said (Arch. Intern. Med. 2012 [doi:10.1001/archinternmed.2011.1666]).

Since it is possible that dabigatran’s negative effects may increase with longer duration of use, the investigators performed a separate analysis excluding three of the seven studies that had exceptionally short (less than 1 month) exposure times. The risk of MI or ACS remained high and significant in this analysis of the data, they noted.

An important limitation of the meta-analysis is that a single large trial, with a study population of 18,113 patients, overshadowed the findings from the other 6 trials, which had populations of 515 to 2,451 patients. In addition, the large trial followed patients for a median of 2 years, while the smaller trials did so for 6 months or less.

Because of this imbalance, the large trial accounted for 59% of the meta-analysis cohort and 74% of the cardiovascular events, they said.

Overall, the findings indicate that dabigatran’s cardiovascular risks should be investigated further, “especially if [the drug] is used in populations at high risk of MI or ACS,” they added.

The “robust” finding by Dr. Uchino and Dr. Hernandez that dabigatran is associated with increased MI “is alarming and emphasizes the need for continued critical appraisal of new drugs after phase III trials,” Dr. Jeremy M. Jacobs and Dr. Jochanan Stessman wrote in remarks taken from an invited commentary that accompanied the meta-analysis (Arch. Intern. Med. 2012 [doi:10.1001/archinternmed.2011.1721]).

The researchers’ results “suggest that physicians [should] step back for a moment, take their own pulse, and retain a critical view as a powerful new drug enters clinical use on a potentially massive scale,” Dr. Jacobs of the Jerusalem Institute of Aging Research at Hadassah-Hebrew University Medical Center and Dr. Stessman of the Hebrew University–Hadassah Medical School, Jerusalem.

The findings also highlight another deeply concerning issue: “the enthusiasm – nearly to the level of euphoria – to embrace the new,” they added.

All seven studies included in the meta-analysis were sponsored by the drug manufacturer, Boehringer Ingelheim. No financial conflicts of interest were reported among the investigators for this current study.

Dr. Jacobs and Dr. Stessman reported having no financial conflicts of interest.

Subject Codes:
top_stories; cardiology; surgery; neurology;


http://www.imng.com


January 09, 2012   04:00 PM EST

BY NASEEM S. MILLER
Elsevier Global Medical News
Breaking News

New federal regulations aim to accelerate the use of electronic payments to health care providers while reducing administrative costs and saving resources.

The interim final regulations – part of a series of regulations coming from the Department of Health and Human Services – standardize the format and content of the transmissions that health plans send to banks when paying claims via electronic funds transfer (EFT) and will require plans to use a trace number to matches the EFT with the remittance advice sent to providers. Currently the EFT and the remittance documents are sent to providers separately, and matching them is difficult.

The new standards took effect on Jan. 1; full compliance will be required by Jan. 1, 2014, according to the agency.

Under the new rules, “health care professionals will spend less time filling out paperwork and more time focusing on delivering the best care for patients,” HHS Secretary Kathleen Sebelius said in a statement.

Further, the rules will cost physicians, hospitals, and other providers little or nothing, since “providers are the receivers of the standardized transactions and not the senders,” according to HHS.

The agency also estimated that widespread use of EFT should save physician practices and hospitals between $3 billion and $4.5 billion over the next 10 years. The most common savings from implementation of electronic fund transfers are in paper, printing, and postage, as well as staff time for processing paper payments and depositing checks.

The cost to implement the new standards across all commercial health plans is estimated at between $18 million and $28 million. Implementation in Medicaid, the Children’s Health Insurance Plan, and the Indian Health Service is estimated at $400,000-$600,000. Meanwhile, the savings for commercial health plans could be as much as $40 million over 10 years, and $31 million for Medicaid, CHIP, and IHS, according to an HHS fact sheet.

Use of EFT, while widespread in many industries – has been slow in health care, partly due to lack of standardization of transactions, HHS officials said.

The new standards are required by the Affordable Care Act, and fall under the Health Insurance Portability and Accountability Act (HIPAA). They are second in a series of regulations that aim to streamline health care administrative transactions within the next 5 years. Future efforts are slated to include a standard unique identifier for health plans and standardized claim attachments.

Subject Codes:
nephrology_urology; infectious; top_stories; sports; ophthalmology; gastroenterology; mental_health; dermatology; orthopaedics; pediatrics; general_primary; oncology; endocrinology; womens_health; pain; allergy; pulmonology; cardiology; rheumatology; surgery; otolaryngology; neurology; gerontology;


http://www.imng.com


January 05, 2012   05:23 PM EST

BY ALICIA AULT
Elsevier Global Medical News
Breaking News

HOT SPRINGS, VA (EGMN) – Using risk adjustment alone to compare surgical site infection rates among hospitals may not be valid, judging by a retrospective analysis of data on colorectal procedures.

An examination of data submitted on 336,190 cases by 237 hospitals participating in the National Surgical Quality Improvement Project (NSQIP) in 2009 revealed that a patient’s underlying disease state is an important contributor to the risk of surgical site infection, said Dr. Robert Cima.

Dr. Cima and his colleagues at the Mayo Clinic Rochester, Minn., identified 24,673 colorectal procedures, using CPT codes. Of those procedures, 6,324 patients had colon cancer, 2,061 had benign neoplasm, 2,859 had rectal cancer, 4,821 had diverticular disease, 764 had ulcerative colitis, 862 had regional enteritis (Crohn’s disease), and 6,982 had other conditions, which included perforation, volvulus, intestinal obstruction, rectal prolapse, fistula, vascular insufficiency and unspecified neoplasms.

They specifically analyzed colorectal procedures because they are associated with the largest rate of surgical site infections (SSI; 5%-30%) and those infections led to a longer length of stay, higher costs, and higher mortality.

To get a baseline rate of SSIs for comparison purposes, the authors queried the data set to determine which procedure had the lowest rate. Benign neoplasms had the lowest overall rate, and because they were not caused by underlying disorders or malignancies, that rate was chosen as the reference, Dr. Cima said at the annual meeting of the Southern Surgical Association.

The authors conducted a regression analysis using the same factors used in the NSQIP risk adjustment: age, body mass index, American Society of Anesthesiology classification, wound classification, and relative value units (RVU) used, which are a surrogate for CPT codes. Odds ratios for SSIs were then calculated for each procedure.

Overall, 13.5% of patients developed an SSI. Rectal cancer patients had the highest overall odds ratio at 1.9, followed by Crohn’s disease, at 1.7. Rectal cancer patients also had the highest risk of superficial incisional SSI at 1.6; diverticular disease patients had a 1.6-fold higher risk than did those with benign neoplasms.

The patients at highest risk for deep incisional infections were those with ulcerative colitis (OR, 2.4), followed by rectal cancer (2.1). Both of those conditions also put patients at higher risk for organ/space infections (OR, 2.2 and 2.1).

The difference in infection rates by underlying disease led the researchers to question whether case mix might have an effect on the infection rates at individual institutions. Looking at the Mayo Clinic’s profile, compared with all NSQIP facilities’ case mix, they found that there was a higher percentage of patients with the higher-risk conditions: rectal cancer, regional enteritis, and ulcerative colitis.

The NSQIP data include a disease diagnosis, but it does not factor that into risk-adjusted figures, which will soon be publicly reported, noted Dr. Cima. Comparisons between hospitals could be misleading if they don’t include case mix, he said. And, there are implications for quality improvement, said Dr. Cima.

“If we had just looked at the overall surgical site infection rate and tried to design studies or processes to just reduce it without consideration of case mix, we would not be able to really determine whether or not we can drive it down,” he said.

“This is a provocative and important study,” said Dr. Danny Jacobs, chairman of the department of surgery at Duke University, Durham, N.C., in commenting on the paper. And, he said, it raises questions about whether the risk-adjustment system being used by NSQIP is adequate.

Dr. Susan Galandiuk, a professor of surgery at the University of Louisville (Ky.), questioned whether infection rates weren’t also influenced by the duration of surgery and whether patients were given appropriate antibiotic prophylaxis.

Dr. Cima said that while many studies have shown that infections rise as the length of surgery increases, it was not clear whether that was a factor in his study.

He agreed with Dr. Jacobs that the paper raised questions. The data do “go to the very heart of using data sets to drive quality improvement,” he said.

Subject Codes:
infectious; surgery;


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January 05, 2012   11:00 AM EST

BY DOUG BRUNK
Elsevier Global Medical News
Breaking News

SAN DIEGO (EGMN) – Obtaining a baseline D-dimer level can identify acutely ill patients at high risk of venous thromboembolism, results from a large analysis have shown.

In fact, the rate of venous thromboembolism (VTE) was 3.5- to 4-fold higher for patients with a baseline D-dimer level more than twice the upper limit of normal, compared with patients whose D-dimer was twice the upper limit of normal or less, Dr. Alexander T. Cohen reported at the annual meeting of the American Society of Hematology.

The findings come from a subset analysis of patients in MAGELLAN, a trial of 8,101 acutely ill, hospitalized adults who were randomized to either oral rivaroxaban (Xarelto) prophylaxis 10 mg once daily for 35 days or to standard enoxaparin (Lovenox) 40 mg once daily for 10 days, followed by placebo. The patients were assessed with ultrasonography on day 10 and day 35. In the overall study population, rivaroxaban met both of its primary outcomes: noninferiority at day 10 vs. enoxaparin and superiority at day 35 vs. enoxaparin, followed by placebo. Rates of clinically relevant bleeding were low in general but were higher for rivaroxaban than for enoxaparin with placebo. MAGELLAN’s primary findings were presented at the 2011 annual meeting of the American College of Cardiology but have not yet been published.

For the current study, outcomes in MAGELLAN were analyzed to investigate the relationship between D-dimer levels and VTE risk, and the effect of rivaroxaban on this risk. Dr. Cohen of the department of surgery at King’s College Hospital, London, and his associates divided patients into two groups: those with D-dimer levels less than or equal to two times the upper limit of normal or less (group 1) and those with D-dimer levels greater than two times the upper limit of normal (group 2).

The primary efficacy outcome was a composite of asymptomatic proximal deep vein thrombosis (DVT), symptomatic DVT, symptomatic nonfatal pulmonary embolism, and VTE-related death. The principal safety outcomes were major and nonmajor clinically relevant bleeding recorded within 2 days after the last intake of study medication. Both outcomes were assessed on day 10 and day 35, and the prespecified net clinical benefit was defined as a composite of the primary efficacy and principal safety outcomes.

The mean age of the patients was 67 years in group 1 and 71 years in group 2. The baseline median D-dimer level was 0.94 mg/mL in all patients. Baseline D-dimer level was higher in patients who experienced a primary efficacy outcome event, compared with those who did not have such an event (a median of 1.98 mg/mL vs. 0.92 mg/mL). Patients in group 2 were about four times as likely to have a VTE by day 10, compared with those in group 1. At day 10, rivaroxaban was noninferior for the primary efficacy outcome, compared with enoxaparin, among patients in group 2.

At day 35, patients in group 2 who were assigned to the rivaroxaban arm had a reduction in their relative risk of the primary efficacy outcome by 29%, compared with those who were assigned to the enoxaparin-placebo arm, a significant difference that translated into an absolute risk reduction of 2.8% (P = .01). No such differences were observed in group 1.

Patients who had a high D-dimer level at baseline were at increased risk of an event occurring between day 11 and day 35, and rivaroxaban reduced that risk, compared with placebo, during this time period, Dr. Cohen said. “Perhaps assessment of D-dimer after 10 days of standard prophylaxis may indicate which patients benefit from rivaroxaban prophylaxis,” he noted.

In both D-dimer groups, the rate of clinically relevant bleeding was significantly higher among patients treated with rivaroxaban, compared with those treated with enoxaparin, followed by placebo, across the entire study period. In the net clinical benefit outcomes analysis, the hazard ratio at day 10 was 1.63 for group 1 and 0.96 for group 2, while the hazard ratio at day 35 was 1.71 for group 1 and 1.03 for group 2.

MAGELLAN was funded by Bayer (which licenses rivaroxaban) and Johnson & Johnson (parent company of Janssen Pharmaceuticals, which manufactures rivaroxaban). Dr. Cohen disclosed that he has served as a medical consultant for, and has received honoraria and clinical trial funding from, numerous pharmaceutical companies, including Bayer, Johnson & Johnson, and Sanofi-Aventis.

Subject Codes:
cardiology; surgery;


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January 05, 2012   10:14 AM EST

Alexander T. Cohen

BY DOUG BRUNK
Elsevier Global Medical News
Breaking News

SAN DIEGO (EGMN) – Patients who receive heparin bridging during an interruption of oral anticoagulation appear to be at a 5.4-fold increased risk of overall bleeding and a 3.6-fold increased risk of major bleeding, without a reduction in risk of thromboembolic events.

Those are key findings from a systematic review and meta-analysis of recently published medical literature presented by Dr. Jovana Yudin at the annual meeting of the American Society of Hematology.

Antithrombotic and thrombolytic therapy guidelines published by the American College of Chest Physicians in 2008 recommended bridging according to an individualized approach (Chest 2008;133[suppl. 6]:299S-339S). “They suggested bridging according to patients’ bleeding and thromboembolic risk,” said Dr. Yudin, a fellow in the hematology residency program at McMaster University, Hamilton, Ont. “Within the last decade, several new studies have been published using periprocedural bridging. In these studies, low-molecular-weight heparin has been used with increased frequency. However, optimal strategies for bridging remain unclear. Our objective was to do a systematic review and meta-analysis of bridging trials published in the last decade to look at thromboembolic risk as well as bleeding risk.”

Dr. Yudin and her associates searched the MEDLINE, EMBASE, and Cochrane Collaboration databases for systematic reviews and meta-analyses of studies published between Jan. 1, 2001, and July 31, 2010, that examined bleeding and thromboembolic events in patients receiving bridging therapy during temporary oral anticoagulation interruption for elective surgical or invasive procedures. Studies were excluded if the reporting of thromboembolic or bleeding outcomes was unclear, or if they focused exclusively on patients with renal failure (ASH 2011; abstract 545). All studies were reviewed by two independent investigators.

The researchers identified and screened 1,164 studies for review. Of these, 35 studies that included 7,169 bridged patients were selected for the final review. Most of the studies (33) were observational, and only two were randomized. The median follow-up was 30 days.

The most common indication for anticoagulation was atrial fibrillation (44%), followed by mechanical valve (24%), prior venous thromboembolism (22%), and other (10%).

The most common preoperative strategy was to discontinue oral anticoagulation more than 3 days in advance. Low-molecular-weight heparin was most commonly used, both preoperatively and postoperatively.

Dr. Yudin reported that thromboembolic events, which were primarily arterial in nature, occurred in 73 of the 7,169 patients (mean rate, 0.96%). The mean rate of overall bleeding was 13.01%, whereas the mean rate of major bleeding was 4.32%.

Eight of the studies included in the final analysis had control groups from which the researchers were able to pull data to determine an odds ratio for thromboembolism with bridging vs. no bridging. These studies included 1,691 bridged patients and 3,493 nonbridged patients. The odds ratio for thromboembolic events was 0.80, with a 95% confidence interval (CI) of 0.42-1.54, “suggesting no risk reduction for thromboembolic events with heparin or low-molecular-weight bridging,” Dr. Yudin said. “There was also no difference between these two groups in the risk for arterial or venous thromboembolism.”

To determine the risk of overall bleeding, the researchers pulled data from 13 studies that included control groups. These studies included 1,935 bridged patients and 5,160 nonbridged patients. The odds ratio for overall bleeding with bridging was 5.40 (95% CI, 3.00-9.74). “This suggested an increased risk of overall bleeding with bridging anticoagulation, but there was significant heterogeneity noted across these studies.”

For major bleeding, five studies with control groups were assessed. These included 1,397 bridged patients and 2,104 nonbridged patients. The odds ratio for major bleeding was 3.60 (95% CI, 1.52-8.50), “again suggesting an increased risk in major bleeding with bridging,” she said. “There was significant heterogeneity noted across studies.”

Dr. Yudin acknowledged that the review had certain limitations: Most of the studies included in the analysis were observational, and only about a third had control groups. “Our control groups consisted largely of low-thromboembolic-risk patients, or patients who were not chronically on vitamin K antagonists, suggesting that they had a different risk profile for thromboembolism than many of the bridged patients,” she said.

The findings “underline the need for studies of higher [methodological] quality in periprocedural bridging,” she concluded. “It also tells us that there is a need for standardized definitions in terms of outcomes. We suspect that much of our heterogeneity had to do with varying definitions for outcomes such as major bleeding.”

Dr. Yudin said that she had no relevant financial conflicts to disclose.

Subject Codes:
cardiology; surgery;


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January 05, 2012   10:29 AM EST

BY DOUG BRUNK
Elsevier Global Medical News
Breaking News

SAN DIEGO (EGMN) – Patients who had severe sickle cell disease and underwent surgery without a preoperative blood transfusion had more than twice as many perioperative complications and 10 times as many severe adverse events as similar patients who received transfusions.

Those are key findings from the TAPS (Transfusion Alternatives Preoperatively in Sickle Cell Disease) trial, a randomized study that was carried out between November 2007 and March 2011 at 22 sites in the United Kingdom, the Netherlands, and Canada.

The findings “show that patients with severe sickle cell disease should be given a blood transfusion before surgery,” Dr. Jo Howard said during a press briefing at the annual meeting of the American Society of Hematology. “In addition, it suggests that we should consider giving a blood transfusion to patients with other types of sickle cell disease.”

The purpose of TAPS was to assess the clinical benefit of preoperative transfusion to alleviate perioperative complications in patients with sickle cell disease who had sickle cell anemia (HbSS) and sickle-beta⁰-thalassemia (HbSbeta⁰) and who were undergoing low- or medium-risk procedures such as abdominal surgery or tonsillectomy.

“Prior to the trial, it was clear that patients with sickle cell disease having surgery were more likely to have complications, but it wasn’t clear whether transfusion decreased these or not, and in which situations [transfusion] should be used,” said Dr. Howard, a consultant hematologist at Guy’s and St. Thomas’ Hospitals, London. “In the United Kingdom in 2005, there was a wide variation in practice, and in fact a decrease in use of blood transfusions in part because of concern about the risks of transfusions.”

The primary outcome of the trial was the number of patients with severe sickle cell disease who had significant complications from randomization to 30 days post surgery. The researchers also tracked the amount of blood received, the number of days spent in the hospital, and the readmission rates.

Of 343 patients initially screened for the trial, 70 were randomized into one of two groups. The 35 patients in group 1 did not receive a blood transfusion. The 35 in group 2 received a top-up transfusion if their hemoglobin levels were less than 9g/dL, or a partial exchange if their hemoglobin levels were 9g/dL or higher. The trial was closed in March of 2011 because a higher proportion of serious adverse events occurred in group 1, compared with group 2.

The final analysis included 33 patients in group 1 and 34 patients in group 2. Dr. Howard reported that 39% of patients in group 1 experienced a perioperative complication, compared with 15% of patients in group 2.

In addition, 30% of patients in group 1 and 3% in group 2 experienced a serious adverse event, primarily acute chest syndrome (seen in 27% of patients in group 1 and in 3% of patients in group 2).

Dr. Howard acknowledged certain limitations of TAPS, including its early closure and the relatively small number of patients enrolled in the trial.

The TAPS trial was sponsored and funded by National Health Service Blood and Transplant in the United Kingdom.

Subject Codes:
surgery;


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January 04, 2012   01:41 PM EST

Jo Howard

BY PATRICE WENDLING
Elsevier Global Medical News
Breaking News

SAN DIEGO(EGMN)–Prophylaxis with rivaroxaban achieved significant reductions in venous thromboembolism, compared with two commonly used drugs when put to the test in 5,346 consecutive, unselected patients undergoing major orthopedic surgery.

The incidence of in-hospital symptomatic venous thromboembolism (VTE) was 2.4% with rivaroxaban (Xarelto), compared with 3.9% with low molecular weight heparin (LMWH), and 5.5% with fondaparinux (Arixtra). This corresponds to a relative risk reduction of 39%, compared with LMWH, and 57% compared with fondaparinux.

Rivaroxaban, an oral Factor Xa inhibitor, also has superior safety with regard to major bleeding and surgical complications, according to Dr. Jan Beyer-Westendorf, with the University Clinic at Dresden (Germany) Technical University.

“Patients in real-world major orthopedic surgery benefit from VTE-prophylaxis with rivaroxaban even more than could be expected from the phase III results of the RECORD trial,” he said at the annual meeting of the American Society of Hematology.

The four phase III RECORD (REgulation of Coagulation in ORthopedic Surgery to Prevent Deep Vein Thrombosis and Pulmonary Embolism) trials compared rivaroxaban with enoxaparin in more than 12,500 patients undergoing knee and hip replacement. The trials did not evaluate fondaparinux or LMWH, despite being the standard of care at many hospitals.

Rivaroxaban was approved in the United States in July 2011 for DVT prophylaxis in adults undergoing hip and knee replacement surgery, and gained a second indication in November 2011 for stroke prophylaxis in patients with nonvalvular atrial fibrillation.

Dr. Beyer-Westendorf and his colleagues analyzed 5,346 consecutive patients who underwent major orthopedic surgery at the university clinic during three periods: 2005-2007 when LMWH was the standard prophylaxis; 2008-2009 when fondaparinux was the standard; and finally from 2010 to June 2011 when rivaroxaban became the clinic’s standard prophylaxis.

In all, 1,055 patients were treated with rivaroxaban, 1,683 with LMWH, and 2,069 with fondaparinux. Of note, previous VTE was more common at baseline in the rivaroxaban group at 4% vs. 1.4% in the LMWH group, and 1.1% in the fondaparinux group, he said.

Rivaroxaban reduced the relative risk of the composite of proximal DVT, pulmonary embolism, and VTE-related death by 29%, compared with LMWH, and 42% compared with fondaparinux, but the difference between the three groups did not achieve statistical significance (1.0% vs. 1.4% vs. 1.7%), Dr. Beyer-Westendorf said.

In a pooled analysis of RECORD 1, 2, and 3, rivaroxaban significantly reduced the composite of symptomatic VTE and all-cause mortality during the 2-week period after surgery, compared with enoxaparin (0.4% vs. 0.8%), according to the Bayer HealthCare website.

In the current analysis, severe bleeding was significantly lower with rivaroxaban at 7.4% vs. 14.9% with LMWH, and 11.1% with fondaparinux.

Bleeding leading to surgical revisions was also significantly lower at 0.4% vs. 1.7% with LMWH, and 1.1% with fondaparinux.

Dr. Beyer-Westendorf pointed out that severe bleeding rates were less than 1% in the RECORD 1-4 trials using a more narrow definition of severe bleeding as overt bleeding outside of the surgical site. Their analysis used the International Society on Thrombosis and Hemostasis criteria for severe bleeding.

Finally, the reduction in VTE events, bleeding, and surgical revisions was correlated with a significantly shorter median hospital stay in patients given rivaroxaban prophylaxis vs. LMWH or fondaparinux (8.3 days vs. 11.6 days vs. 9.3 days).

Dr. Beyer-Westendorf said it was unlikely that changes in anesthesia or surgical practice over the study period could have attenuated the results. In addition, the researchers conducted a matched-pair analysis to evaluate whether the benefits of rivaroxaban were due to selection or detection bias. Outcomes remained superior for rivaroxaban after matching patients according to age, gender, type of surgery, and history of VTE. Complete compression ultrasound testing also remained constant at about 13% from 2005 to 2010 before falling to 8.2% in 2011 due to fewer complete compression ultrasound–positive findings, Dr. Beyer-Westendorf noted.

“These findings in a large real-world surgery cohort are robust and not significantly influenced by a selection or detection bias,�� he said.

Dr. Beyer-Westendorf disclosed research grants from and serving as a speaker for Bayer HealthCare, which markets Xarelto.

Subject Codes:
new_drugs; orthopaedics; rheumatology; surgery; gerontology;


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January 03, 2012   10:04 AM EST

Jan Beyer-Westendorf

BY ALICIA AULT
Elsevier Global Medical News
Breaking News

HOT SPRINGS, VA. (EGMN) – Payer mix improved and collections for all surgical departments increased at Wake Forest University’s Baptist Medical Center after an acute care surgery practice was created at the 872-bed hospital.

Acute care surgery combines trauma, critical care, and emergency general surgery with an eye toward both filling gaps in care for critically injured patients and taking some of the pressures off crowded emergency departments, said Dr. Preston W. Miller of the department of surgery at Wake Forest University in Winston-Salem, N.C. The American Association for the Surgery of Trauma (AAST) has developed a curriculum as well as training programs for acute care surgery, which has led to the accreditation of seven such programs so far, according to Dr. Miller.

Before the acute care service was begun in September 2008, the trauma and critical care service was staffed by three surgeons, with an additional two surgeons participating in call, he said. Emergency general surgery was conducted by seven surgeons who also had elective specialties.

When the acute service was established, all responsibility for emergency surgery was transferred to six surgeons: the three original trauma surgeons and an additional three surgeons who were hired for the service. Trauma and critical care surgery was managed by the acute service, and the elective surgery was provided by the original group of seven surgeons with elective specialties.

Dr. Miller and his colleagues retrospectively studied the impact of the acute care program on the elective service at Baptist Medical Center. They defined elective surgery as any procedure done on a weekday between 6:30 a.m. and 5:00 p.m. Nonelective procedures were listed as emergent in the operative case log, were conducted between 5:01 p.m. and 6:29 a.m., or were performed on weekends.

Work relative value units for the surgery department increased from 102,740 in 2007 to 124,432 in 2008, when the acute care surgery unit was launched. Total RVUs increased to 137,584 in 2009 and held steady at 136,263 in 2010. Most of the increase occurred in the acute care service, but there was only a minimal decline in RVUs on the elective side in 2009 and 2010.

Total collections jumped from $5.8 million in 2007 to $7 million in 2008 and to $8 million in 2009. There was a slight decline to $7.8 million in 2010. About $3 million of the total was for the acute care service in 2009 and 2010.

There was a shift toward more private payers and less Medicare, Medicaid, and self-pay in 2009 and 2010, said Dr. Miller. Private payers increased by 40%. Meanwhile, there was a 77% decrease in Medicaid and an 86% drop in self-pay.

From 2008 to 2009 (the first full year of the acute care service), nonelective cases on the elective service dropped from 470 to 157. Elective cases increased from 2,162 to 2,372. The trends continued into 2010.

Similarly, on the acute care service, nonelective cases increased from 391 in 2007 to 614 in 2008, and to 997 in 2009. By 2010, nonelective cases had risen to 1,328. Elective cases on the service rose from 533 in 2008 to 649 in 2009, but declined to 325 cases in 2010.

Elective RVUs decreased by 8% but collections increased by 7%, most likely because of the better reimbursement offered by private payers. The combined collections for the acute service and the elective service increased the contribution to the surgery department by more than $2 million a year, he said.

Dr. Martin A. Croce said that the acute care service “is really becoming the last bastion of the essence of general surgery,” but that Dr. Miller’s paper shows that it will not take cases away from nontrauma general surgeons.

“The group from Wake has demonstrated that the formation of an acute care service creates a win-win-win situation,” said Dr. Croce, professor of surgery and chief of the division of trauma and critical care at the University of Tennessee Health Science Center, Memphis.

Trauma surgeons, general surgeons, and the hospital all benefit, said Dr. Croce.

Dr. L.D. Britt, the Brickhouse Professor of Surgery and chairman of the department of surgery at Eastern Virginia Medical School, Norfolk, said that acute care surgery “is an evolving specialty that is indeed an important concept.” He lauded the study, but also said that many questions remain about how to operate and optimize such a service. For instance, he asked, how many surgeons are necessary to sustain a service?

Responding to the comments, Dr. J. Wayne Meredith, president of the Southern Surgical Association and chair of general surgery at Wake Forest Baptist, said he believed that it took at least seven surgeons to have an effective service.

At Baptist, there was an increase in elective surgeries because the acute care service addressed a backlog. And it freed up capacity in the operating room: Some surgeries – like gallbladders – could be moved to night.

There is an agreement among the Wake Forest Baptist surgeons that those who are there at night can decide whether to operate; but if they are not there at night, they also should not refuse to take a case that requires their help then, Dr. Meredith said.

He added that patient outcomes had improved since the institution of the acute care service. Length of stay for emergency surgery has dropped from 10 days to 8 days.

Subject Codes:
surgery; emergency_trauma;


http://www.imng.com


January 03, 2012   10:07 AM EST

BY ALICIA AULT
Elsevier Global Medical News
Breaking News

HOT SPRINGS, VA. (EGMN) – An analysis of a large database of bariatric surgery patients has found that those with metabolic syndrome had dramatic improvements in comorbidities but a slightly higher rate of adverse events after 90 days.

Overall, patients with metabolic syndrome tend to be sicker and to have a greater incidence of adverse outcomes and higher mortality than do obese patients who don’t have the syndrome, said Dr. William B. Inabnet III, professor of surgery at Mount Sinai School of Medicine in New York.

He and his colleagues at Mount Sinai also determined that the reduction in weight was procedure dependent. “A careful assessment of risk-benefit ratio is warranted to develop the optimal clinical pathway for treating these patients,” said Dr. Inabnet at the annual meeting of the Southern Surgical Association.

The researchers examined BOLD (Bariatric Outcomes Longitudinal Database) to identify patients who had undergone bariatric surgery from June 2007 to November 2010 and had metabolic syndrome.

BOLD is maintained by the American Society for Metabolic and Bariatric Surgery Center of Excellence program, and includes 1,157 surgeons at 884 hospitals. The data are self-reported, but some data are verified by on-site inspections. The surgical interventions covered in the registry include gastric banding, Roux-en-Y gastric bypass, sleeve gastrectomy, and biliopancreatic diversion with duodenal switch.

A modified scoring system (0-5) was used to assess comorbidities. For the purposes of the study, metabolic syndrome was defined as a hypertension score greater than 3, a diabetes score greater than 2, a dyslipidemia score greater than 2, and a sleep apnea score greater than 3. (Sleep apnea is not usually included in the definition of metabolic syndrome, but the researchers were interested in the condition as a comorbidity, said Dr. Inabnet.)

Overall, there were 186,567 patients in BOLD, including 23,106 patients who had metabolic syndrome. Those with metabolic syndrome were more likely than other obese patients to be male, older, and white, and to have sleep apnea and an ASA (American Society of Anesthesiologists) classification of 3 or greater. Body mass index was similar for both groups at 47 kg/m².

Gastric bypass was the most commonly performed procedure, and was the preferred method in patients with metabolic syndrome, followed by gastric banding, sleeve gastrectomy, and duodenal switch. And, said Dr. Inabnet, the researchers “were truly amazed to see that the vast majority of these cases were performed with laparoscopic approaches.”

At 30 days, those with metabolic syndrome had increases in mortality, serious complications, readmissions, and reoperations, compared with other obese patients. The increases continued as time went on, and became more pronounced at 90 days post surgery, said Dr. Inabnet.

Overall mortality was very low (0.1%) for the entire cohort of 186,567 patients.

Mortality rates differed by procedure, however. The gastric band patients had the lowest rate (0.1%), followed by 1.2% for duodenal switch, 0.3% for sleeve gastrectomy, and 0.4% for gastric bypass. The serious complications, readmissions, and reoperations at 90 days were also lowest for gastric band patients, followed by duodenal switch, sleeve gastrectomy, and gastric bypass patients.

Metabolic syndrome was associated with the greatest risk for serious complications, according to the authors’ regression model. Those who received the gastric band had a 2.79-fold increase in risk at 90 days, compared with bypass patients, who had a 1.34-fold increased risk.

Follow-up data at 1 year were available for a little more than half of those with metabolic syndrome (12,144 patients). The data show that the decrease in BMI was procedure dependent. The greatest decrease in mean BMI (from 51 to 32) was seen in those who had a biliopancreatic diversion. Mean BMI dropped from 46 to 39 in gastric band patients, from 49 to 36 in those who had a sleeve gastrectomy, and from 48 to 32 in those who had the bypass.

Reduction of comorbidities was also greatest in the duodenal switch group, followed by the bypass, sleeve, and gastric band procedures. For instance, diabetes resolved in 74% of patients who had the duodenal switch, compared with only 28% of those who received the band. There were big reductions in hyperlipidemia and sleep apnea for all the procedures.

The data are limited in that they are self-reported, noted Dr. Inabnet. Even so, the “study confirms the previously held hypothesis that metabolic syndrome confers increased morbidity,” said Dr. Bruce Schirmer, vice-chair of the department of surgery at the University of Virginia, Charlottesville. In discussing the paper, Dr. Schirmer noted that BOLD also seemed to show lower overall weight loss and resolution of comorbidities than was previously reported by individual institutions.

The database, however, has its advantages, said another discussant, Dr. William O. Richards, chair of the department of surgery and director of the surgical weight loss center at the University of South Alabama, Mobile. “This paper is important because it’s another one of the studies emanating from prospective [collections of data across the United States] from hundreds of surgeons, and convinces me we are ever more confident in reporting results not just from a single surgeon but from actual practice,” said Dr. Richards.

He questioned whether the low mortality rate was a reflection of surgeons’ opting to avoid procedures in high-risk, older obese patients, or whether it was a reflection of the success of the centers of excellence system.

Dr. Inabnet said that there were 200 patients older than age 75, and although the data are currently too young to allow the measurement of any trends, it doesn’t seem that older patients are being operated on less often than are younger patients.

“What is the best operation? That really is the million dollar question,” he said. The data show that the Roux-en-Y procedure provides the best overall risk profile, but he added that the sleeve gastrectomy is increasing in prevalence and may eventually prove to be a good choice.

Dr. Inabnet, Dr. Schirmer, and Dr. Richards reported no conflicts.

Subject Codes:
diabetes; general_primary; surgery;


http://www.imng.com


January 02, 2012   11:54 AM EST

Dr. William Inabnet

BY ALICIA AULT
Elsevier Global Medical News
Breaking News

HOT SPRINGS, VA. (EGMN) – Since tort reform in Texas, the number of lawsuits and associated costs have decreased, but patient complaints to the state medical board and board investigations of physicians have risen, according to an analysis presented at the meeting.

Dr. Ronald M. Stewart and his colleagues from the University of Texas Health Science Center at San Antonio obtained publicly available data from the Texas Medical Board and compared the 7-year period before tort reform (1996-2002) and the 6 years after the law was enacted (2004-2010).

The data were adjusted for the increase in the physician population; before reform there were about 170 physicians per 100,000 residents. After the law went into effect, the number rose to 195 physicians per 100,000, said Dr. Stewart, chairman of the department of surgery.

Before reform, about 125 complaints per 1,000 physicians were made to the medical board. That number increased by 13% after reform, to around 140 complaints per 1,000 physicians, said Dr. Stewart.

The rate of investigations increased from 38 per 1,000 to 52 per 1,000, with 5% of physicians the subject of a medical board inquiry. Postreform, there were more disciplinary actions when compared to open investigations, at about 8 per 1,000 in the latter period. Before reform, 0.5 per 1,000 physicians were ordered to revoke or to voluntarily surrender their licenses; after reform, that value rose to 0.8 per 1,000, a significant increase, noted Dr. Stewart.

The most striking change before and after reform was the decline in financial penalties. The state collected a total of $4.7 million in the postreform period. To put that figure into context, the San Antonio department of surgery alone spent $4.8 million on liability settlements in the prereform period, said Dr. Stewart.

It’s not clear why complaints and disciplinary actions went up, Dr. Stewart said. Having access to electronic information and greater awareness of the ability to complain to the medical board probably spurred more patient reporting.

The increases in investigations and disciplinary actions were mainly driven by the legislature, according to Dr. Stewart. The lawmakers mandated greater oversight by the medical board, so that undoubtedly led to an increase in enforcement.

“It appears that tort reform in Texas has done what it was intended to do,” increased the activity of the Texas Medical Board, and decreased the activity of the medical liability tort system, said Dr. Russell Postier, chairman of the surgery department at the University of Oklahoma, Oklahoma City, in discussing the paper.

Further, it appears to have increased the number of physicians practicing in the state, which could “make other states take notice and potentially enact tort reform,” Dr. Postier said.

Dr. Stewart said that putting malpractice in the hands of the medical board had decreased costs and been generally positive. For instance, he said, the medical board process is transparent and allows more input from stakeholders like physicians.

“There’s no question that the benefits of tort reform in my opinion outweigh the potential negative consequences to physicians,” he said.

Dr. Stewart and Dr. Postier reported no financial conflicts.

Subject Codes:
surgery;


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December 27, 2011   01:48 PM EST