By Mark S. Lesney
Elsevier Global Medical News

Surgery for malignant pleural mesothelioma remains a complicated and controversial issue. Thus far, the benefits of surgery vs. nonsurgical treatment have yet to be demonstrated.

Complete resection with surgery alone (R0) appears theoretically unattainable since it is impossible to eradicate residual microscopic disease, regardless of the surgical method used. Hence, most surgical treatment today is coupled to various adjuvant treatments, primarily a trimodality mode with radiotherapy and chemotherapy, according to Dr. Raja M. Flores, professor and chief of thoracic surgery, Mount Sinai School of Medicine, New York.

A “curative” surgical procedure remains an elusive goal, and thus the focus of lung surgery for malignant pleural mesothelioma (MPM) has shifted to R1 surgical resection for cytoreduction in the hope of prolonging life, relieving symptoms, and enhancing the effectiveness of adjuvant therapies. This approach has often meant a shift from the more radical extrapleural pneumonectomy (EPP), when possible, to the more lung-sparing pleurectomy/decortication (PD) procedure, according to Dr. Flores (Sem. Thorac. Cardiovasc. Surg.2009;21:149-53).

EPP involves a radical en bloc resection of the lung, pleura, diaphragm, and pericardium. PD involves resection of the parietal and visceral pleurae, pericardium, and – when necessary – the diaphragm, but it spares the entire lung. Both operations are technically complex and require extensive surgical expertise.

The operative mortality rate of EPP in the literature ranges from 4% to 15%, vs. and 1% to 5% for PD. In addition, PD has lower morbidity than does EPP. But the two techniques are not interchangeable, according to Dr. Flores. The choice of surgical technique depends on multiple factors, and the decision is often made at the time of surgery because the preoperative imaging may have underestimated the amount of disease present.

Staging is critical in determining the appropriate procedure, and the merits of each surgical approach have been debated in several recent clinical and registry trials examining individual mortality and morbidity of these procedures at different stages, coupled with the use of a variety of adjuvant therapies. However, many decisions are based on surgical conjecture and bias rather than scientific data.

Evidence indicates that PD provides a survival advantage for patients with stage I MPM, which may be accounted for by “lower mortality, lower postoperative adverse events, and greater lung capacity when relapse occurs,” according to Dr. Flores. However, he explained, most patients with mesothelioma will present at a stage that requires EPP to eradicate all gross disease. PD can provide an R1 resection in early-stage disease, but as the tumor enlarges and invades the lung, fissures, and costophrenic sulcus, a PD is suboptimal regardless of resection of the pericardium and diaphragm.

There is, however, a critical balance between optimal cytoreduction and morbidity that varies across stages for these two procedures. For stage II disease, there is a “trend toward improved survival for EPP, despite an inherently higher tumor stage than PD,” Dr. Flores said.

Stage III disease proved more complex, with similar survival data seen for both EPP and PD. Ultimately, “one should focus on obtaining a complete macroscopic resection based on the extent of tumor” for this stage of disease, choosing the best procedure accordingly, he advised.

For more advanced (stage IV) disease characterized by diffuse chest wall invasion and extensions through the diaphragm to the underlying peritoneum, the situation is much different.

“The tumor may be amenable to EPP, but there will be gross residual tumor left behind in the hemithorax. Because one of the most likely sites of recurrence is the contralateral pleura, the patient is better served by preserving lung function,” Dr. Flores explained.

In stage IV disease, PD trended toward better survival, presumably because “when disease spreads to the contralateral lung, PD or debulked patients will be less symptomatic and better functionally able to tolerate systemic therapy because of their greater pulmonary reserve,” he said.

“The goal is to remove all gross tumor while preserving as much of the lung as possible. Every patient and clinical situation is unique; therefore, treatment is difficult to generalize. Find an experienced mesothelioma surgeon you trust and leave it in their hands,” Dr. Flores said in an interview.

Ultimately, the situation remains complex. Dr. Heyman Luckraz of the New Cross Hospital, Wolverhampton, United Kingdom, and his colleagues recently reported results with 139 patients. EPP was chosen for clinically fit patients with stage I disease, while patients with advanced disease or who were unfit for EPP underwent PD. “EPP may only have a limited role in diffuse MPM, particularly as neither operative procedure is curative. Ultimately, the place of EPP will only be determined by randomized trial in comparison to PD in stage I disease with both groups receiving adjuvant therapy,” the investigators concluded (Eur. J. Cardio-Thorac. Surg. 2010;37:552-6).

Whether such trials will ever be performed is an open question. Despite the recent Mesothelioma and Radical Surgery (MARS) trial, which demonstrated the possibility of randomizing patients to surgical vs. nonsurgical treatment, there will likely never be a randomized clinical trial powered enough to completely solve the puzzle, according to Dr. Tom Treasure of the University College of London (Eur. J. Cardio-Thorac. Surg. 2010;37:509-10).

Efforts continue to develop surgical alternatives with less mortality and morbidity than those of the standard EPP and PD procedures. For example, Dr. M.D. Kluger and colleagues at Columbia University, New York, reported the phase I and II results of a recent clinical trial on a two-stage operative cytoreduction procedure coupled with intraperitoneal chemotherapy (Eur. J. Surg. Oncol. 2010;doi:10.1016/j.ejso.2010.07.001). They found that their protocol offered median survival comparable to that of one-stage protocols; rates of morbidity, mortality, visceral resections were relatively low and length of stay was relatively short despite the need for two operations.

Ultimately, surgery might be totally immaterial in some cases. In two recent papers, the type of surgery was not found to be predictive of survival. The poor prognosis of sarcomatoid MPM was independent of the extent of surgery, unlike other cell types (Ann. Thorac. Surg. 2010;89:907-11), and the combination of several immunohistochemical markers was found to be the only valid prognostic indicator of survival, including type of surgery (Eur. J. Cardio-Thorac. Surg. 2010;38:245-53).

None of the authors mentioned in this article had disclosures deemed relevant to their reported research.

Subject Codes:
OncologyEX; pulmonology; surgery;


http://www.imng.com


September 01, 2010   04:03 PM EDT

In this photo, the tumor has been completely resected. It takes highly trained suregons to perform an en bloc resection of the lung, pleura, lining of the heart (pericardium), diaphragm, and tumor. The chest is free of all gross disease.

By Mary Ann Moon
Elsevier Global Medical News
Breaking News

Prophylactic mastectomy and salpingo-oophorectomy significantly decrease mortality as well as the risks of breast and ovarian cancer among women who carry BRCA1 or BRCA2 mutations, according to a report published in the Sept. 1 issue of JAMA .

These risk-reducing surgeries benefit both carriers who have not yet developed malignancies and those who have already been treated for breast or ovarian cancer and are still at risk for further primary disease, said Dr. Susan M. Domchek of the University of Pennsylvania, Philadelphia, and her associates.

Most previous studies that examined whether the prophylactic excisions actually impact mortality did not address their efficacy according to subjects’ mutation status or prior cancer diagnosis. With no proof of such efficacy, some clinicians and patients may have avoided the surgeries. Some may have believed that the excisions conferred little added protection against further malignancies, especially in the setting of chemotherapy-induced menopause or hormonal therapy, Dr. Domchek and her colleagues said.

The investigators assessed outcomes in a cohort of 2,482 BRCA1 and BRCA2 mutation carriers identified at 22 medical centers in North America and Europe that were participating in the Prevention and Observation of Surgical Endpoints (PROSE) consortium. The study subjects were enrolled in 1974-2008 and followed through the end of 2009 (median follow-up, 3.65 years).

Approximately 10% of these women underwent prophylactic mastectomy, and 40% underwent prophylactic salpingo-oophorectomy.

No breast cancers developed in mutation carriers who underwent prophylactic mastectomy, whereas breast cancers did develop in 7% of those who declined prophylactic mastectomy. This confirms that prophylactic mastectomy is highly effective at significantly reducing breast cancer in women at high risk, the investigators said (JAMA 2010;304:967-75).

Among women who underwent prophylactic salpingo-oophorectomy, only 1% subsequently developed ovarian cancer, and only 11% subsequently developed breast cancer. In contrast, among women who declined prophylactic salpingo-oophorectomy, about 6% subsequently developed ovarian cancer, and 19% subsequently developed breast cancer.

Prophylactic salpingo-oophorectomy cut the risk of ovarian cancer by 70% in the subgroup of women who did not have prior breast cancer and decreased it even further, by 85%, in those who did have prior breast cancer. This finding illustrates why breast cancer patients may want to know about their BRCA mutation status even if they have undergone bilateral mastectomy: Prophylactic salpingo-oophorectomy may well protect them from developing a new primary malignancy in the ovaries.

Among women with no prior breast cancer, prophylactic salpingo-oophorectomy reduced breast cancer risk by 37% in carriers of the BRCA1 mutation and by 64% in carriers of the BRCA2 mutation.

Prophylactic salpingo-oophorectomy also decreased all-cause mortality, which was only 3% among women who underwent the procedure, compared with about 10% among those who did not. The prophylactic excision also significantly reduced breast cancer mortality (2% vs. 6%) and ovarian cancer mortality (0.4% vs. 3%), compared with no prophylactic salpingo-oophorectomy.

In an editorial accompanying this report, Dr. Laura Esserman and Dr. Virginia Kaklamani said that only 10% of the subjects in this study chose prophylactic mastectomy, and only 38% chose prophylactic salpingo-oophorectomy (JAMA 2010;304:1011-2). Now that the study results confirm that these procedures reduce not just cancer risk but also mortality, “women who test positive for BRCA1 or BRCA2 can make more informed choices about whether to consider prophylactic surgery or to opt for intensive surveillance,” and “women considering prophylactic interventions should be aware that options have changed and improved,” the physicians wrote.

Laparoscopic salpingo-oophorectomy in this setting is relatively low risk and can be done on an outpatient basis; invasive node sampling is no longer required as part of the procedure, said Dr. Esserman of the University of California, San Francisco, and Dr. Kaklamani of Northwestern University, Chicago.

Cosmetic options also have improved for prophylactic mastectomy. A total skin-sparing approach provides a more natural appearance, is safe and reliable, and now is routine in many major breast centers.

For women who worry that positive results on genetic testing will raise their insurance premiums, clinicians can reassure them that the Genetic Information Nondiscrimination Act of 2008 protects them from insurance and employer discrimination based on genetic profiles, said Dr. Esserman and Dr. Kaklamani.

Among the institutions providing support for the study were the University of Pennsylvania, the U.S. National Cancer Institute, the Cancer Genetics Network, the Dana-Farber/Harvard Cancer Center, and the U.K. National Institute for Health Research. Dr. Domchek, Dr. Esserman, and Dr. Kaklamani reported no financial conflicts of interest.

Subject Codes:
top_stories; OncologyEX; general_primary; womans_health; surgery;


http://www.imng.com


August 31, 2010   04:00 PM EDT

By Diana Mahoney
Elsevier Global Medical News
Breaking News

Formal training in robotic prostatectomy, compared with the more typical transition from laparoscopic prostatectomy done by performing on a consecutive cohort of patients, improves the pathologic and surgical outcomes associated with the robot-assisted procedure, a study has shown.

In a prospective comparison of the robot-assisted laparoscopic radical prostatectomy (RALP) outcomes achieved by surgeons formally trained in the robotic technique and those with formal training in conventional laparoscopic radical prostatectomy (LRP), the robot-trained group had significantly lower overall postsurgical margin (PSM) rates, T3 tumor margin rates, and apical and lateral margin rates, as well as shorter procedure times, Dr. Eric O. Kwon and colleagues reported in the August issue of Urology.

To compare the outcomes, the investigators reviewed 286 RALPs performed between August 2008 and March 2009 by 12 urologists on a single DaVinci 4S robot system at Kaiser Permanente West Los Angeles Medical Center as part of a new RALP program. Of the 12 urologists, 4 had received fellowship training in robotic surgery and 8 had formal LRP training. The robot-trained surgeons performed 121 RALPs and the robot-naive surgeons performed 165 RALPs, the authors wrote (Urology 2010;76:363-8).

With respect to patient characteristics, demographics and preoperative parameters were comparable between the two groups with the exception of a higher percentage of clinical T1c patients in the robot-naive group – a difference not reflected in the final pathology because of comparable prostatectomy size, Gleason score, and pathologic size among the patients, the authors stated.

For the robot-trained and robot-naive surgeons, respectively, the overall PSM rates for were 24% and 34.6%, a significant difference, the authors reported. A comparison of PSM rates at the apex, base, lateral, anterior, and posterior locations on the prostate also showed significantly lower rates for the robot-trained surgeons at the apical (8.3% vs. 21.2%) and lateral margins (1.7% vs. 7.3%), they wrote, noting that the difference in apical margins could be attributable to “technical differences resulting from a lack of experience with the robotic instrumentation during apical dissection.” It��s also possible, they said, that difficulty with the distal placement of the DVC [dorsal venous complex] stitch may have forced a more proximal division of the DVC.

The rates of interoperative major and minor complications were similar for patients in both groups, and there were no significant differences in blood transfusions, the authors reported.

Significant differences were observed in operative times. “Not surprisingly,” the authors wrote, “the robot-trained group was able to complete their procedures in 10%-15% less time than the robot-naive group.” The median prostatectomy time for the robot-trained group was 97 minutes vs. 114 minutes for the robot-naive group, they reported. Further, a breakdown of the times showed significant differences during specific portions of the procedure, including during dissection of the vas deferens and seminal vesicles, opening of Denonvillier’s fascia ligation and control of the DVC, transaction of the bladder neck, and control of the vascular pedicles and nerve-sparing, they wrote, noting that there was no significant difference in median times between the two groups of surgeons during the dropping of the bladder or apical dissection.

Although the differences in prostatectomy times resulted in a median total console time 18 minutes shorter and a median total OR time 24 minutes shorter for the robot-trained group compared with the robot-naive group, “we acknowledge that although these times are statistically significant, they may not be clinically significant,” the authors wrote.

The findings of this study suggest that, at least in the initial period of a new RALP program, the perioperative results may be superior for surgeons with formal robotic training, according to the authors. “With accrual of more cases over time, we may also determine learning curves with respect to both groups,” they wrote. “With longer follow-up, we can compare long-term postoperative outcomes, such as cancer control, urinary continence, and erectile function.”

The authors did not have any conflicts of interest with respect to this study deemed relevant by the editors of the journal.

In an invited commentary at the end of the article, Dr. Maxwell V. Meng stated: “The differences between the trained and naive groups were not great, namely, there was no statistically significant difference in positive surgical margins for T2 tumors, the difference in median total operative time was only 24 minutes, and the incidence of major and minor complications was comparable. With the accumulation of additional information, it will be interesting to see what the true learning curve for robotic prostatectomy is, and to compare the differences in outcomes in both the trained and naive groups with increasing numbers of cases.

“The study also raises the question whether the experience with new surgical procedures is best limited to a few surgeons, likely hastening learning, or whether all interested surgeons should be involved early in the process, thereby diluting the experience,” he added.

Dr. Meng is from the department of urology, University of California, San Francisco. He had no conflicts deemed relevant by the editors of the journal.

Subject Codes:
nephrology_urology; OncologyEX; surgery;


http://www.imng.com


August 31, 2010   02:25 PM EDT

By Diana Mahoney
Elsevier Global Medical News
Breaking News

Emergency general surgery procedures are associated with high overall morbidity and serious morbidity/mortality, as well as widely varying quality of care among hospitals, a large national study has shown.

Dr. Angela M. Ingraham, a clinical scholar-in-residence at the American College of Surgeons in Chicago, and her colleagues used the 2005-2008 ACS National Surgical Quality Improvement Project (NSQIP) database to assess the 30-day outcomes of three common emergency general surgery procedures as well as hospital-level performance across procedures. They identified 45,602 patients who underwent emergency appendectomy, cholecystectomy, or colorectal resection at 222 NSQIP-participating hospitals nationwide.

“We selected these procedures because appendectomy and cholecystectomy represent two of the most commonly performed emergency surgery procedures, and emergency colorectal resections are associated with a high risk of adverse events,” the investigators said in the August issue of the journal Surgery.

For the analysis, the outcomes of interest included overall morbidity and serious morbidity/mortality (defined as documentation of at least one of the following NSQIP complications: organ space surgical-site infection, wound dehiscence, neurologic event, cardiac arrest, MI, bleeding that requires transfusion of more than 4 units of blood, pulmonary embolism, ventilator dependence for more than 48 hours, and progressive or acute renal insufficiency or sepsis or septic shock).

Not unexpectedly, patients undergoing emergency colorectal resection fared the worst: Overall, 4,202 of 8,990 colorectal resection patients (46.74%) experienced any morbidity within 30 days of the procedure, and 3,736 (41.56%) experienced serious morbidity or death, the investigators reported. Of the 30,788 patients who underwent appendectomies, 1,984 (6.44%) had any morbidity and 1,140 (3.70%) experienced serious morbidity or death. And of 5,824 patients who had emergency cholecystectomies, 503 (8.64%) had any morbidity and 371 (6.37%) experienced serious morbidity or death, they said (Surgery 2010;148: 217-38).

The investigators used stepwise logistic regression to identify predictors of any morbidity and of serious mortality/morbidity, and to generate patient-level predicted probabilities of an outcome. They used expected probabilities to calculate observed:expected ratios for overall morbidity and serious morbidity/mortality for each hospital.

The risk factors identified as strong predictors of overall morbidity and serious morbidity/mortality following all three procedures were American Society of Anesthesiologists (ASA) class, functional status, and preoperative sepsis, the investigators said. For appendectomies, the presence of abscesses or peritonitis was associated with a significantly higher risk of both overall morbidity and serious morbidity/mortality. Following cholecystectomy, the highest risks of overall morbidity and serious morbidity/mortality were observed with postoperative diagnoses of acute cholecystitis and “other” findings; and for colorectal resection, hemorrhage was associated with the highest risk of overall morbidity.

More favorable outcomes were observed in patients whose emergency appendectomies and cholecystectomies were performed laparoscopically, they noted.

The observed:expected ratio ranges for overall morbidity were 0.26-2.36 for appendectomy, 0-3.04 for cholecystectomy, and 0.45-1.51 for colorectal resection. For serious morbidity/mortality, the ratio ranges were 0.23-2.54 for appendectomy, 0-4.28 for cholecystectomy, and 0.59-1.75 for colorectal resection.

To evaluate the consistency of hospital-level performance across procedures, the investigators included patient outcome information from 95 of the 222 NSQIP hospitals that submitted at least 20 cases of each of the three procedures. Using weighted kappa statistics, they demonstrated substantial variability across emergency cases for most hospitals, which were divided into tertiles based on observed:expected ratios. For overall morbidity for all procedures, seven hospitals (7.4%) were rated in the highest, or best, tertile and eight (8.4%) were rated in the lowest tertile. For serious morbidity/mortality for all procedures, nine hospitals (9.5%) were rated in the highest tertile and eight (8.4%) were rated in the lowest tertile, they reported.

The finding of consistent performance for only a significant minority of the hospitals suggests that most hospitals have areas in which care can be improved, the investigators said. “Given the high-risk nature of emergency surgery, the best practices of hospitals with consistently favorable outcomes should be identified and disseminated to facilitate targeted quality improvement initiatives at hospitals with more variable or worse outcomes.”

The investigators acknowledged that the study included only hospitals participating in NSQIP and, for hospital-level comparisons, only those hospitals submitting the required minimum number of emergency surgery cases across all three procedures. As a result, the generalizability of the findings may be limited, the investigators said.

The investigators reported no financial conflicts of interest relevant to this study.

Subject Codes:
gastroenterology; surgery; emergency_trauma;


http://www.imng.com


August 31, 2010   01:53 PM EDT

Angela Ingraham

By Diana Mahoney
Elsevier Global Medical News
Breaking News

LAS VEGAS (EGMN) – Pulmonary complications following bariatric surgery occur infrequently but are associated with significantly increased rates of postoperative morbidity and morbidity, according to a large national study that also identified modifiable preoperative risk factors for poor pulmonary outcomes.

In an analysis of data from the American College of Surgeons’ 2007 National Surgical Quality Improvement Program (NSQIP) – a prospective database comprising more than 200,000 inpatient and outpatient operations performed at 183 representative U.S. hospitals – postoperative pneumonia and postoperative respiratory failure were the most common non–wound-related complications reported among 12,252 patients who underwent bariatric surgery, together accounting for 26% of the overall 30-day morbidity rate, Dr. Prateek K. Gupta said at the annual meeting of the American Society for Metabolic and Bariatric Surgery.

“In comparison, renal complications and cardiac complications accounted for 7% and 2%, respectively, of postoperative morbidity,” he noted. The analysis included patients who underwent Roux-en-Y gastric bypass, adjustable gastric banding, and gastroplasty.

Specifically, postoperative pneumonia was reported in 72 patients and postoperative respiratory failure (defined as reintubation after extubation or a total duration of ventilator-assisted respirations during postop hospitalization for a period 48 hours) was reported in 86 patients, said Dr. Gupta of Creighton University in Omaha, Neb.

In patients with postoperative pneumonia, “2.78% died within 30 postoperative days, compared with 0.17% of patients without pneumonia,” Dr. Gupta said, and 10.47% of patients with respiratory failure died within 30 days, compared with 0.12% of patients without respiratory failure.

Patients with these pulmonary complications also had significantly longer hospital stays. “The median length of stay for postoperative pneumonia patients was 14 days, compared with 2 days for patients without pneumonia, and a similar, significant trend was observed in patients with respiratory failure,” Dr. Gupta reported.

In multivariate analyses, a history of heart failure was a major risk factor for postoperative pneumonia, with an adjusted odds ratio of 10.7. “To our knowledge, [heart failure] was not previously shown to be a risk factor for pneumonia,” Dr. Gupta noted. “The association could be due to perioperative worsening of cardiopulmonary function, although the precise reasons are unclear and need to be investigated further.”

Additional risk factors for postoperative pneumonia included history of stroke with neurologic deficit (OR, 9.8); consumption of more than two alcohol drinks per day (OR, 9.0); history of severe chronic obstructive pulmonary disorder (OR, 4.5); the presence of an open wound (OR, 3.8); higher American Society of Anesthesiologists Physical Status classification (OR, 2.0); and smoking, reported Dr. Gupta.

With respect to postoperative respiratory failure, “patients with a history of myocardial infarction within 6 months prior to surgery had 50 times increased risk for this complication,” Dr. Gupta said. “History of MI is known to be a risk factor for morbidity, but has not previously been shown to be a risk factor for respiratory failure,” he said.

Other preoperative risk factors for respiratory failure included receiving a preoperative transfusion of more than four units of blood within 72 hours of surgery (OR, 19.0); consumption of more than two alcohol drinks per day (OR, 7.8); history of severe COPD (OR, 4.6); decreasing independent functioning status (OR, 4.6); hypertension (OR, 2.4); and diabetes (OR, 2.0), according to Dr. Gupta.

Patients whose bariatric surgery was deemed “emergent” were six times more likely to experience respiratory failure than were those who had nonemergent procedures, “but the nature of the emergencies was unclear,” Dr. Gupta noted. “We speculate that these are additional surgeries in patients with prior bariatric surgery.”

Awareness of the preoperative risks that might lead to pulmonary complications is important for patient optimization and selection prior to surgery, Dr. Gupta stressed.

For example, in the case of a 50-year old, 400-pound woman with hypertension, diabetes, COPD, and heart failure who smokes and has partial functional status, “the calculated risk [based on the adjusted odds ratios] for postoperative pneumonia and postoperative respiratory failure, respectively, would be 50% and 28%,” Dr. Gupta explained. “For this patient, prior to surgery, we would optimize the heart failure and COPD and encourage preoperative weight loss to decrease the risk of pulmonary complications.”

Through the use of specific strategies to address and optimize modifiable risk factors in bariatric patients, “it’s possible to control the incidence of postoperative pneumonia and respiratory failure, thereby improving surgical outcomes,” Dr. Gupta concluded.

The study’s findings are limited by the nature of the NSQIP database, which was developed with consideration for all surgeries rather than bariatric surgery in particular. For example, although the initial analysis included 52 preoperative demographic and comorbid variables, obstructive sleep apnea was not included as a comorbidity despite its prevalence in obesity, Dr. Gupta said. Additionally, pulmonary function tests were not available for the analysis; “however, COPD gold stage is based on [a forced expiratory volume in 1 second] of less than 75%, so pulmonary function data could be extrapolated from that,” he stated.

Dr. Gupta reported having no financial conflicts of interest relevant to this study.

Subject Codes:
gastroenterology; diabetes; endocrinology; pulmonology; surgery;


http://www.imng.com


August 25, 2010   03:01 PM EDT

By Amy Rothman Schonfeld
Elsevier Global Medical News
Breaking News

CARLSBAD, Calif. (EGMN) –Delayed thrombotic events have been observed following the cessation of double antiplatelet therapy in patients who have received an Enterprise stent for an intracranial aneurysm.

Seven of 213 patients in the Interstate Collaboration of the Enterprise Stent Coiling (ICES) Multicenter Registry experienced a thrombotic event 2-24 weeks after placement of the stent and stopping aspirin and clopidogrel, Dr. J. Mocco reported at the annual meeting of the Society of NeuroInterventional Surgery. Another two patients experienced acute cases of stent thrombosis.

Ten sites in the United States and Puerto Rico participate in the registry to rapidly provide large-volume, real-world results regarding experience in using the Enterprise Vascular Reconstruction Device and Delivery System (J. Neurosurg. 2009;110:35-9) for the treatment of intracranial aneurysms. The stent system is designed to assist in the embolic coiling of wide-neck aneurysms.

In the seven cases, the patients either did not comply with the drug regimen or stopped taking the antiplatelets on the order of the physician.

The data suggest that early cessation of double antiplatelet therapy is not ideal, although it is currently unclear what the optimum time course should be, said Dr. Mocco, an endovascular neurosurgeon affiliated with the University of Florida, Gainesville.

Use of the Enterprise stent to assist with aneurysm coiling was associated with 90% or greater occlusion in 88% of aneurysms. Permanent morbidity (all minor) occurred in 1.4% of patients.

None of the thrombotic events were associated with coil prolapse or parent vessel tortuosity, said Dr. Mocco. Three events had no angiographic corollary and two were diagnosed based on symptoms.

Dr. Mocco gave his presentation during a session sponsored by Codman Neurovascular, the manufacturer of the Enterprise stent. He disclosed that he received no direct financial support from Codman and the data were generated independent of commercial influence, although the University of Florida receives an educational grant and consulting fees from Codman. He is a consultant to several other companies that manufacture cerebrovascular therapies.

Subject Codes:
cardiology; surgery; neurology;


http://www.imng.com


August 24, 2010   01:11 PM EDT

By Amy Rothman Schonfeld
Elsevier Global Medical News
Breaking News

CARLSBAD, Calif. (EGMN) – The use of perfusion imaging criteria to select stroke patients for reperfusion therapy led to the successful treatment up to 72 hours after symptom onset in a review of 53 patients.

The 90-day clinical outcomes of patients who met specific perfusion criteria were similar regardless of whether treatment occurred before or after 6 hours following symptom onset, Dr. Aquilla Turk reported at the annual meeting of the Society for NeuroInterventional Surgery.

Due to an increased risk of intracranial hemorrhage, revascularization treatments for acute ischemic stroke are generally now limited to a 4.5-hour window of time after symptom onset for the use of intravenous tissue plasminogen activator (tPA) or 6-8 hours for intraarterial tPA or mechanical thrombectomy. “Physicians must go beyond time restrictions and use imaging-based procedures to better select patients for intervention,” said Dr. Turk, an interventional neuroradiologist affiliated with the Medical University of South Carolina, Charleston.

“Utilization of perfusion-based techniques is a viable clinical strategy for identifying acute stroke patients for endovascular therapy. Clinical outcomes can be obtained that are similar to those of clinical trials, irrespective of time constraints in appropriately selected patients,” he said.

Dr. Turk reviewed the first 2 years (2008-2009) of his institution’s acute stroke experience since it began selecting patients for reperfusion therapy based on anatomic and physiologic imaging criteria instead of time. All patients had evidence of large cerebral vessel occlusion on CT angiography.

The patients had a mean age of 65 years and mean National Institutes of Health Stroke Scale score of 17.55. They received treatment a mean of 10 hours after symptom onset (median, 6 hours), ranging from 1.75 hours to 72 hours. Treatment consisted of intravenous tPA (within 3 hours of symptom onset) followed by intraarterial thrombectomy in 18 patients and intraarterial thrombectomy in 35 patients. All patients received intraarterial tPA (5-30 mg) during the thrombectomy. Angiographically, treatment restored blood flow to a TIMI (Thrombosis in Myocardial Infarction) level of 2 or better for 96% of the patients.

Clinical outcomes at 90 days as measured by the modified Rankin Scale showed no differences between 26 patients treated within 6 hours after symptom onset and 27 patients treated after 6 hours. Modified Rankin Scale scores were 0-2 in 36% and 37%, respectively, and 0-3 in 56% and 52%, respectively. No significant differences were found in 90-day mortality (23% for both groups).

Dr. Turk disclosed financial relationships with Boston Scientific Corp., Nfocus Neuromedical Inc., Pulsar Vascular, Biomerix Corp., and Penumbra Inc.

Subject Codes:
general_primary; surgery; neurology; emergency_trauma;


http://www.imng.com


August 23, 2010   10:16 AM EDT

By Patrice Wendling
Elsevier Global Medical News
Breaking News

MINNEAPOLIS (EGMN) – Smoothing hospital occupancy over the entire week could reduce weekday inpatient crowding, according to two retrospective cohort studies.

Traditionally, hospital occupancy is higher on weekdays than on weekends, typically because elective admissions are scheduled for Monday with an eye toward discharging patients by the weekend. This results in peaks and troughs in occupancy that cause midweek crowding and unused capacity on other days, particularly weekends.

Indeed, a study of 22,310 pediatric admissions, of which 22% were scheduled, found that Mondays generated 25% of all scheduled patient-hours defined as the number of patients multiplied by length of stay (LOS). Tuesday and Wednesday generated 20% each, whereas Saturdays and Sundays combined generated less than 3% of patient-hours.

Not surprisingly, Wednesday and Thursday had the highest peak daily occupancy, and were the days most likely to have occupancy above 90% and 95%, Dr. Evan Fieldston and his colleagues reported in a poster presentation at the Pediatric Hospital Medicine 2010 meeting, which was sponsored by the Society of Hospital Medicine, the American Academy of Pediatrics, and the Academic Pediatric Association.

The median LOS for scheduled patients admitted on Monday and staying less than 1 week was significantly longer at 2.49 days compared with 2.08 days for their counterparts admitted on any other weekday.

Hospitals usually respond to midweek crowding by attempting to reduce LOS, but that may not sufficiently increase functional capacity, explained Dr. Fieldston, a pediatric hospitalist at Children’s Hospital of Philadelphia. By proactively managing the inflow of scheduled admissions, hospitals can avoid unused capacity and optimize patient flow.

“Many people [believe] that nobody wants to work on weekends and no patients want to come in on weekends, but there are a number of patients who would be very happy to come on the weekends and some staff who would like to work weekends for family reasons,” he said in an interview. “It’s a matter of aligning incentives.

“The other important thing to think about with staffing is that the estimated cost of adding a bed to a children’s hospital is $2 million per bed. So if you’re going to build 20 beds to deal with your overcrowding, $40 million dollars can bring in a lot of staff.”

The researchers conducted a second study to quantify the theoretical effect of smoothing on inpatient occupancy at 39 tertiary care children’s hospitals in the Pediatric Health Information System. A retrospective smoothing algorithm was used to set each hospital’s daily occupancy to the hospital’s mean occupancy for each week. Post-smoothing reductions in weekly maximum occupancy were averaged for the entire year for each hospital.

Before smoothing, there were 550,543 discharges, with a median LOS of 3 days. The hospitals’ mean midnight occupancy ranged from 71% to 108% on weekdays and from 66% to 95% on weekends, Dr. Fieldston reported. Over all of the hospitals, the median difference between weekday and weekend occupancy was 8.2% points. For a 300-bed hospital, this would translate to a 24-patient lower census on weekends than on weekdays.

Before smoothing, the number of hospitals with mean weekday occupancy above threshold was 33 at greater than 85% occupancy, 25 at more than 90% occupancy, 14 at more than 95% occupancy, and 6 at greater than 100% occupancy. After smoothing, the number of hospitals above threshold was reduced to 32, 22, 10 and 1, respectively, which was significant at each threshold, except the 85%-threshold, he said.

By smoothing, 39,607 patients from the 39 hospitals could be removed from exposure to occupancy exceeding 95%.

Only a small percentage of all admissions (median, 2.6%; range, 0.02%-9.2% across hospitals) would have to be scheduled differently each week to achieve within-week smoothing of occupancy, Dr. Fieldston said. This represents about one-tenth of scheduled admissions per week.

The authors acknowledged that the study assumed a fixed number of beds for the whole year, that the ability to smooth occupancy rests on an adequate number of scheduled admissions to shift during a week, and that midnight census rather than peak daily census was used to determine occupancy.

Still, they concluded that “smoothing has the potential to help optimize patient flow and increase quality and safety in health care delivery.”

If this were to occur, however, then the negative associations surrounding weekend hospital stays would have to change.

“The issue of the weekends not being the best time to be in the hospital shouldn’t be a reason to not bring in patients,” Dr. Fieldston said. “We truly ought to be a 7-day institution.

“We shouldn’t make a hospital less safe for the patients who need to be there on the weekends. And potentially, you have the positive catch-22 that if you purposely schedule patients to be there on the weekend, you will bring in revenue and make it in everyone’s best interest to make the weekend safer and provide better care to all patients,” said Dr. Fieldston, who reported no conflicts of interest.

Subject Codes:
pediatrics; general_primary; surgery;


http://www.imng.com


August 23, 2010   09:09 AM EDT

Evan Fieldston

By Naseem S. Miller
Elsevier Global Medical News

Gone are the large white boards at the emergency room of Inova Fair Oaks Hospital in Fairfax, Va. Two large flat-screen computer monitors have taken their place. The patient information displayed on the screens is constantly updated through small tablets cradled in the arms of physicians and nurses.

If you ask the emergency department staff, they will tell you they can’t imagine having to go back to paper.

Going from paper to the electronic system wasn’t an overnight process. It took time. It took training. And it cost money. But it has paid off by improving efficiency, quality, and throughput, say officials at Inova Health System, of which Inova Fair Oaks is a part.

The health system was named as one of the most wired hospitals in the nation by Hospitals & Health Networks’ annual most wired survey. The 99 hospitals and health systems that made the list were recognized in the categories of most improved, most wired, most wireless, and most wired in small and rural settings.

The list is the result of 555 submitted surveys, which were filled out voluntarily by the institutions.

The survey, conducted since 1999, aims to benchmark hospitals’ progress in information technology. The hospitals were recognized for achievement of IT applications in the areas of clinical quality and safety, care continuum, infrastructure, and business and administrative management.

The 2010 survey shows that the most wired hospitals are further along (82%) than other hospitals (51%) in deploying computerized provider order entry (CPOE) systems. In addition, wired hospitals have made strides in areas such as medication management.

Under the Health Information Technology for Economic and Clinical Health Act, hospitals are incentivized to use electronic health record (EHR) systems in a meaningful way with financial bonuses through 2016. Yet, experts say that much more work needs to be done before the majority of hospitals will achieve the HITECH goal by then.

When hospitals do comply, however, the benefits are great on the practice side, according to Geoff Brown, Inova Health System’s chief information officer. Implementing the right electronic systems can help improve quality of patient care and efficiency at the hospitals, he said.

This is especially true for specialists such as hospitalists, who tend to care for a variety of patients. Having to view the patients’ information and status quickly can be laborious in paper, but an electronic system that displays the patient history, allergies, and medications can be a lot more helpful. “It’s all about efficiency, patient quality, and patient outcome,” Mr. Brown said.

So what does it mean to be an ideal wired hospital?

Dr. Franklin Michota, director of academic affairs in the hospital medicine department of the Cleveland Clinic, said that it starts from a patient-focused perspective: electronic medical records that are available to everyone who sees the patient, information that a patient can access, patients’ ability to log their diet and exercise in a system, and patients’ ability to communicate with their health care provider.

In other words, “all information, all vital signs, all notes, and all orders are paperless,” Dr. Michota said. And for a truly efficient hospital, that system is integrated with billing, supply chain, and other systems such as the regulatory requirements.

But the nation’s health care systems and providers – big and small – have a long way to go before achieving that ideal, said Dr. Michota.

While the financial sector has long had online banking and national and international access to ATMs, hospitals in the same city are still unable to connect with each other, much less connect to hospitals and doctors’ offices elsewhere in their state or across the nation.

That’s mostly due to lack of standardization, according to Dr. Michota. Hospitals tend to tailor their electronic tools to meet the needs of their specific system of care. As a result, there isn’t a standard EHR system that hospitals can buy and implement.

Dr. Michota expressed doubt about the incentives in HITECH for hospitals to get wired. “They say you’ve got to figure out a way to do it, and if you do it, you might get a few carrots. They haven’t made a good business case for hospitals to do this.”

Others are more hopeful. Mr. Brown of Inova said that the meaningful-use criteria provide an incentive that didn’t exist before. And then there is the incentive to boost physician recruitment. Mr. Brown observed that many graduating residents won’t join a health system or practice that’s not wired. “For new doctors, [being wired] is an expectation,” he said.

Dr. Michota said he wasn’t convinced that being a wired hospital is a major selling point. Some doctors may prefer to work with a wired hospital, and “some physicians who like paper may run away from wired hospital.”

Yet, he added, being a wired hospital “may be a marker for a well-organized and well-managed system.”

There’s no disputing the fact that being a wired hospital benefits hospitalists, “because we’re a group of physicians who trade patients back and forth,” Dr. Michota said. “We do a lot of signing in and signing out of patients who are really sick, and there are a lot of important details that need to be exchanged.

“I think for hospitalists, fully wired hospitals are attractive, because they let you multitask,” he said.

Subject Codes:
orl; general_primary; womans_health; cardiology; surgery; emergency_trauma;


http://www.imng.com


August 20, 2010   02:34 PM EDT

Franklin A. Michota

By S. Y. Tan, M.D., J.D.
Elsevier Global Medical News

Question: Regarding physician liability arising from medication injuries, which of the following is most accurate?

A. Doctor is liable if drug was prescribed for unapproved off-label use.

B. Doctor is liable for failing to warn of significant risks.

C. Doctor is liable for failing to warn of all complications.

D. Patient did not ask about side effects and therefore was contributorily negligent.

E. Liability will attach to manufacturer for a “defective product.”

Answer: B. The informed consent doctrine requires that physicians discuss all material risks, including rare but serious risks. Choice A is incorrect because prescribing a drug for an “off-label” use may be an acceptable community practice even though FDA approval is absent or still pending. However, it is prudent for the doctor to document in the records the reason for using the drug. Choice C is overly broad. A warning is required for all material risks (i.e., those that significantly affect the patient’s decision to accept or reject the recommended treatment), but a warning is not necessary for all risks.

Patients are assumed to have little or no knowledge of medications, and they have no legal duty to inquire about their side effects. The doctor, on the other hand, has an affirmative duty to warn of these side effects. In a malpractice case alleging lack of informed consent due to failure to warn, the defense cannot plead contributory negligence, so choice D is incorrect. Finally, E is also incorrect. The “learned intermediary” doctrine stipulates that the doctor, not the pharmaceutical company, is liable for medication-related injuries as he/she is a learned professional who directly communicates with the patient and who does the actual prescribing. This puts the doctor in the hot seat for an adverse drug reaction, unless the drug company has been negligent in identifying and/or communicating the risk.

Disclosure of Material Risks

In order for patients to meaningfully give their consent to treatment, they should have sufficient information regarding the doctor’s treatment plans. The consent must also be given voluntarily, and not be coerced. The notion of patient autonomy is so entrenched that the law imposes upon the practitioner the duty to disclose three fundamental aspects of treatment, easily remembered by the mnemonic PAR (P = procedure [or medication/device], A = alternatives, R = risks).

What constitutes a material risk is at the heart of the controversy surrounding the informed consent doctrine. Generally speaking, the patient should be informed of all serious risks, even if unusual or rare. However, in one court case, a 1% risk of hearing loss required disclosure (Scott v. Wilson, 396 S.W.2d 532 [Tex. Civ. App. 1965]), whereas in another, the court appeared to say that a 1.5% chance of visual loss did not (Yeats v. Harms, 393 P.2d 982 [Kan. 1964]). The California Supreme Court has stated that “material information is that which the physician knows or should know would be regarded as significant by a reasonable person in the patient’s position when deciding to accept or reject the recommended medical procedure,” that “a (material) fact must also be one which is not commonly appreciated,” and that the scope of disclosure may be expanded in patients with “unique concerns or lack of familiarity with medical procedures” (Truman v. Thomas, 27 Cal.3d 285 [1980]). There is, however, no legal requirement to deliver a “mini-course in medical science” (Cobbs v. Grant, 8 Cal.3d 229 [1972]).

Warren v. Schecter is one of the most dramatic cases to confront the material risk issue. The plaintiff won a $9.6 million judgment against the doctor for his failure to disclose risk of osteoporosis (Warren v. Schecter, 67 Cal.Rptr.2d 573 [Cal. 1997]). Dr. Schecter had performed gastric surgery on Janet Warren for peptic ulcer disease, and had warned the patient of the risks of bowel obstruction, dumping syndrome, and anesthetic death. He did not believe osteoporosis, osteomalacia, and bone pain were risks of surgery, and so did not discuss those risks with her. The plaintiff testified at trial that had Dr. Schecter warned of the risk of metabolic bone disease, she would not have consented to surgery. A second operation was undertaken because she developed postoperative dumping syndrome and alkaline reflux gastritis, and the surgeon again failed to advise her of the risk of metabolic bone disease. She again asserted that she would not have consented to the second surgery had she been duly advised.

The plaintiff subsequently developed severe osteoporotic fractures, and filed a malpractice lawsuit alleging that Dr. Schecter was liable under an informed consent theory for performing surgery without advising her of the risk of bone complications. The jury found that Dr. Schecter did not disclose to Ms. Warren all relevant information that would have enabled her to make an informed decision regarding surgery and that a reasonably prudent person in her position would not have consented to surgery if adequately informed of all the significant perils. Judgment was entered requiring a lump sum payment of $1,824,285 and periodic payments for future care totaling $9.6 million over 34 years.

Other Aspects of Disclosure

In addition to risks associated with surgery or a medication, courts have also looked at other aspects of disclosure in the doctor-patient relationship. Some litigated examples include disclosing the limited experience of a neurosurgeon (Johnson v. Kokemoor, 545 N.W.2d 495 [Wis. 1996]), financial incentives amounting to a breach of fiduciary responsibility (Moore v. The Regents of the University of California, 793 P.2d 479 [Cal. 1990]), and requiring a surgeon’s disclosure of his positive HIV status (Estate ofBehringer v. The Medical Center at Princeton, 192 A.2d 1251 [N.J. Super. 1991]) or his alcoholism (Hidding v. Williams, 578 So.2d 1192 [La.App. 1991]). However, in Arato v. Avedon, the California Supreme Court held that the law did not require physicians to inform their terminally ill patients of their prognosis and life expectancy (Arato v. Avedon, 858 P.2d 598 [Cal. 1993]).

An example of statutory law regarding informed consent can be found in Hawaii Revised Statutes §6713. Amended by the 2003 legislature, the statute mandates disclosure of “recognized material risks of serious complications or mortality” but did not define the word “material.” This amended language replaced the earlier version’s “recognized, serious, possible risks, complications and anticipated benefits,” arguably lightening the doctor’s duty regarding risk disclosure. In reality, the new language is unlikely to have a significant practical effect. An earlier 1976 version of the law merely required the disclosure of “probable risks and effects.”

Dr. Tan writes the “Law & Medicine” column, which regularly appears in Internal Medicine News, an Elsevier publication. He is professor of medicine and former adjunct professor of law at the University of Hawaii, Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. It is adapted from the author’s book, “Medical Malpractice: Understanding the Law, Managing the Risk” (2006).

Subject Codes:
gastroenterology; general_primary; surgery; emergency_trauma;


http://www.imng.com


August 17, 2010   01:30 AM EDT

S.Y. Tan

By Mary Ellen Schneider
Elsevier Global Medical News

In less than 6 months, doctors can begin to qualify for tens of thousands of dollars in incentive payments from the federal government for using electronic health record technology. Many physicians are asking: How do I get ready?

The first step, experts agree, is to prepare your practice. Implementing an electronic health record (EHR) effectively is only partially about the technology, said Mary Griskewicz, senior director for ambulatory information systems at Healthcare Information and Management Systems Society (HIMSS), a nonprofit organization.

Most of the work is about reengineering the practice, assessing and changing processes and workflows. “This is not a small task, in particular for small practices,” she said.

And before practices jump into an implementation, Dr. Steven Waldren, director of the Center for Health IT at the American Academy of Family Physicians, suggests that they examine their motivation for using an EHR. He cautioned physicians not to do it just to take advantage of the new federal incentives.

Physicians who qualify as “meaningful users” of EHR technology through the Medicare program can receive up to $44,000 over 5 years, and those who qualify through the Medicaid program can earn about $64,000. But that may not cover the costs of a new system, Dr. Waldren said, so physicians should have other reasons for making the switch.

“They shouldn’t be doing this for the $44,000,” Dr. Waldren said. “They should be doing it because they believe it’s the right thing to do for them, their practice, and their patients. Without that, you don’t have the commitment to make it actually happen.”

Once a practice has decided to purchase an EHR and laid the ground work with the staff, there are still a number of challenges. For example, under the HITECH Act, which established the EHR incentive program, physicians can qualify only if they are meaningful users of certified EHR technology. While the government has released regulations defining meaningful use requirements, as well as requirements for certification, there are currently no certified products on the market. The first products are expected to gain certification sometime this fall, according to the Office of the National Coordinator for Health Information Technology, which is shepherding this effort.

But the current lack of certified products shouldn’t keep physicians from shopping for a system now, experts said. One way to deal with it is to build a guarantee of certification into the contract with the vendor. Physicians just need to be sure to get any assurances in writing, said Dr. Waldren. And they need to be clear on the terms of the guarantee. For example, will the guarantee allow you to get your money back if the vendor fails to become certified or does it allow you to withhold payments until the vendor becomes certified?

Physicians also should look to include service level agreements in their contacts with vendors, Dr. Waldren said. This ensures that the practice will get specific levels of support within certain time frames. If the company fails to deliver on the promised level of service, the practice may be able to make reduced payments or hold payments until that service level is met. These agreements could become important, Dr. Waldren said, since vendors are likely to be very busy as more practices adopt EHRs over the next few years.

When choosing an EHR product, there are several factors to consider, Ms. Griskewicz said, such as whether the software will fit in with the workflow of the practice and whether it is usable by everyone in the office.

One way to answer some of those questions is to talk to clinicians at other practices who have already implemented the product. It’s best to try to find practices that are similar to your own, Ms. Griskewicz said. And ask about integration issues such as how the system will work with existing billing software or how it can help the practice to handle future regulatory changes such as the switch from ICD-9 to ICD-10, she said.

Physicians should consider future meaningful use requirements when choosing a product, Dr. Waldren advised. Right now, physicians have to meet stage 1 criteria for meaningful use, but the requirements will get more difficult in stages 2 and 3 and require different functionality from the EHR technology, he said.

For now, physicians may be able to meet many of the early requirements through the implementation of e-prescribing and registry programs. Since the law does not require that physicians implement a full EHR system to qualify for incentive payments, physicians who are buying an EHR product for the first time may want to consider purchasing individual EHR modules, Dr. Waldren said.

The modules are significantly less expensive than traditional full systems. However, physicians who are considering a modular approach need to find out how the vendor would support stages 2 and 3 of meaningful use. And they would need a plan for how to move their data if they decided to switch to a different system later, he said.

For those practices that have already implemented an EHR system, the work is not over. They now have to ensure that they can meet the meaningful use requirements and that their system will be certified under the new federal rules. Many vendors will be offering upgrades to meet the certification requirements at varying costs.

If you’re satisfied with your current system, it makes sense to stay with that vendor even if certification requirements can���t be met right away, Dr. Waldren said. Although physicians can begin to qualify for meaningful use on Jan. 1, 2011, they can start submitting information to the government as late as October 2012 and still be eligible for the full incentive payments under Medicare.

Physicians who are not satisfied with their current system and who want to switch to a new product should consider that it may take some time to migrate the data from one product to another, Dr. Waldren added. Since vendors will be focused on trying to add as many new users as possible, getting the support and service for data migration may be challenging, he said.

As physicians consider their options, the key is to get educated, Ms. Griskewicz said. She recommends that physicians seek out trusted sources such as the Centers for Medicare and Medicaid Services and their medical professional societies, many of which are offering free Webinars and other online information. “The big thing right now is that they educate themselves as to what are the requirements” and what they need to do and what is the best fit for their practice, she said.

Don’t Wait, but Don’t Rush

Dr. David Blumenthal, the national coordinator for health information technology, has been making the rounds, getting the word out to physicians about the new meaningful use requirements and how to qualify for incentive payments for using EHRs.

During recent Webinars offered by professional medical societies, Dr. Blumenthal told physicians that they should get started on EHR implementation, but that they don’t have to rush to be using the system by Jan. 1, when the new incentive program begins. At that point, physicians can begin to apply to the Centers for Medicare and Medicaid Services to become meaningful users. Those who qualify could begin receiving incentive payments as early as May 2011, according to Dr. Blumenthal. However, under the Medicare program, physicians can take advantage of the full amount of incentive payments, just at a later date, as long as they can become meaningful users by Oct. 1, 2012.

“You have time to learn to be a meaningful user,” Dr. Blumenthal said during a Webinar sponsored by the Medical Group Management Association.

For physicians who need assistance selecting or implementing EHR technology, Dr. Blumenthal recommended that they contact their local regional extension centers. The Office of the National Coordinator for Health Information Technology has awarded grant money to set up 60 of these centers around the country. The centers are focused on assisting primary care physicians in small practices and in underserved areas, but no practices will be turned away, Dr. Blumenthal said. For more information about the regional extension program, go to http://healthit.hhs.gov/extensionprogram.

Subject Codes:
nephrology_urology; infectious; sports; ophthalmology; orl; gastroenterology; health_care_reform; OncologyEX; mental_health; diabetes; dermatology; orthopaedics; pediatrics; general_primary; endocrinology; pain; womans_health; allergy; pulmonology; cardiology; rheumatology; surgery; neurology; emergency_trauma; gerontology;


http://www.imng.com


August 19, 2010   04:13 PM EDT

Mary Griskewicz

By Sharon Worcester
Elsevier Global Medical News
Breaking News

The use of implantable gentamicin-impregnated collagen sponges did not reduce the sternal wound infection rate following cardiac surgery in a prospective, randomized, controlled trial of 1,502 patients who were at high risk of infection because of diabetes and/or obesity.

Dr. Elliott Bennett-Guerrero of Duke University in Durham, N.C., and his colleagues reported their findings Aug. 18 in JAMA.

The findings directly contradicted those of a 2005 Swedish study, which found that the sponges reduced surgical wound infections by 53%, and which served as strong preliminary data for the current trial (Ann. Thoracic. Surg. 2005;79:153-62).

The sponges are approved in 54 countries, and the current phase III study was designed to “confirm these promising data and support regulatory approval in the United States.” However, the overall wound infection rates at 90 days were statistically similar at 8.4% and 8.7%, respectively, in patients who received standard care plus surgical site implantation of two of the topical antibiotic sponges, and in patients who received standard care with no additional intervention, researchers found. There were 753 patients in the sponge group and 749 in the standard care group,

Like the overall wound infection rates, the superficial and deep sternal wound infection rates were also similar in the treatment and control groups, at 6.5% and 6.1%, and 1.9% and 2.5%, respectively. Additionally, no differences were seen between the treatment and control groups in regard to the rehospitalization rate for sternal wound infection (3.1% and 3.2%, respectively), or in ASEPSIS score (mean, 1.9 and. 2.0, respectively) the investigators found (JAMA 2010;304:755-62).

The ASEPSIS score is a measure of additional treatment, presence of serous discharge, erythema, purulent exudates, separation of the deep tissues, isolation of bacteria, and duration of inpatient stay. Points are assigned for each variable and the scale has a minimum score of 0, with no theoretical maximum, the investigators explained.

Patients in the single-blind study were enrolled at 48 U.S. centers between Dec. 21, 2007, and March 11, 2009. Those randomized to the treatment group underwent insertion of two sponges with a total gentamicin dose of 260 mg, which was the same dose used in the Swedish study. Both groups received standardized care with prophylactic systemic antibiotics and rigid sternal fixation, with the treatment group also undergoing implantation with the sponges.

The groups were balanced regarding baseline characteristics, including age, weight, diabetes, and smoking history, and also in regard to perioperative variables.

As for why the antibiotic sponges failed to reduce infection rates in this study as they did in the Swedish study, the investigators suggested that important quality control measures used in their study – but not in the Swedish study – might be to blame. They cited measures including on-site monitoring and source data verification, central adjudication of outcomes by an independent blinded committee, and the inclusion of a large number of hospitals (48 in the U.S. study, compared with 2 in the Swedish study).

The researchers also wrote that ethnic and regional differences, such as varying distribution of bacterial pathogens between countries, could also explain the differing outcomes. For example, no cases of methicillin-resistant Staphylococcus aureus occurred in the Swedish trial, but in the U.S. study 6.3% of patients had MRSA growth from sternal wound infection, which may not be sensitive to gentamicin.

“Thus, variations in the distribution of bacterial pathogens among countries could affect efficacy in a trial of infection prevention such as the present one,” they said, also noting that the findings underscore the importance of large validation trials, as “positive single-center trials are often not confirmed in larger multicenter trials.”

The U.S. study was sponsored by Innocoll Technologies Ltd., the maker of the gentamicin-collagen sponges, and Dr. Bennett-Guerrero reported that he is in discussions with Excited States LLC regarding a consulting agreement to advise on a clinical trial involving surgical wound infection prevention. Another author on the study, Dr. T. Bruce Ferguson Jr., reported receiving honoraria from Innocoll Technologies Ltd. for serving on a steering committee.

Subject Codes:
infectious; top_stories; diabetes; new_drugs; dermatology; endocrinology; cardiology; surgery;


http://www.imng.com


August 17, 2010   04:00 PM EDT

By S. Y. Tan, M.D., J.D.
Elsevier Global Medical News

Question: A medical resident in the emergency department administered gentamicin to a renal patient, but failed to adjust the antibiotic dose. He had not consulted the supervising attending physician, who was on call from home. In a lawsuit for this medical error, which of the following is best?

A. Unsupervised or poorly supervised house-staff officers increase the risk of medical negligence.

B. Unless it can be shown that medical error caused patient injury, the health care providers will win this lawsuit.

C. Under tort law, a trainee is judged by much the same standard as that of a fully qualified doctor.

D. The attending physician is generally liable for resident malpractice under the doctrine of vicarious liability.

E. All are correct.

Answer: E. A review found that in 200 consecutive malpractice cases involving residents working in the emergency department, 64 cases (32%) “were attributable to house officers apparently functioning in a nonsupervised capacity, or to residents on rotation from specialty training or moonlighting in an unsupervised capacity” (Ann. Emerg. Med. 1984;13:709-11). Malpractice liability accrues only when patient injury is proximately caused by the negligence of tortfeasors, and medical residents are generally held to the same standard of care as a qualified doctor. Attending physicians are directly liable for their own negligence, as well as vicariously liable for residents’ actions because of their supervisory role, although some authors have considered failure to supervise a form of direct rather than vicarious liability (JAMA 2004;292:1051-6). Some courts have viewed the attending physician as the captain of the ship and the resident as a borrowed servant who has been “loaned” to the physician in charge of the case (JAMA 1970;213:181-2).

In Rockwell v. Stone, an anesthesiology resident missed the patient’s vein when he tried to inject sodium thiopental. The intra-arterial or extravasated injection (which one happened was unclear) of this induction agent led to arterial vasospasm and thrombosis, irreversibly compromising the blood supply to the patient’s arm and eventually necessitating amputation. The chief of anesthesiology, who was the resident’s supervisor, was found vicariously liable for the resident’s negligence(173 A.2d 48 [Pa. Super. 1961]).

In another case, an ob.gyn. resident performed a tubal ligation, but the patient subsequently became pregnant and underwent a therapeutic abortion, followed by a hysterectomy. The court decided that “even though the surgical procedure was actually performed by a resident, the attending physician and hospital were under a duty to see that it was performed properly. It is their skill and training as specialists which fit them for that task, and their advanced learning which enables them to judge the competency of the resident’s performance” (McCullough v. Hutzel Hospital, 276 N.W.2d 569 [Mich. App. 1979]).

What about the liability of the on-call attending physician who customarily takes calls from home, and may not have previously met the patient? Although there is a duty to supervise the trainee(s), the on-call status alone may not be enough to create a doctor-patient relationship. Decisions are mixed on this point. One court dismissed a negligence claim for failure to supervise two emergency department residents in the treatment of a young girl who died with undiagnosed chicken pox pneumonia (Prosise v. Foster, 544 S.E.2d 331 [Va. 2001]). Yet an on-call agreement was sufficient for another court to impose a doctor-patient relationship upon the supervising attending, with concomitant duty of due care to the patient. That case involved mismanagement of labor that resulted in serious neurologic injury to the newborn (Lownsbury v. VanBuren, 762 N.E.2d 354 [Ohio 2001]).

A supervisor may not be liable when the trainee was performing tasks that he or she is reasonably expected to know. In Richardson v. Denneen, the surgical attending asked the resident to finish suturing and dressing an incision before leaving the operating room. The resident applied phenol instead of alcohol to the skin, with subsequent injury. The court found that it was proper practice for an attending to leave the operating room while the resident sutured the skin – a simple task (82 N.Y.S.2d 623 [N.Y. Super. 1947]). In another case, a neurology resident failed to respond to calls from the recovery-room nurses who had noticed that the patient was displaying decreased movement of the extremities. As a result of the delay, the patient eventually expired from a blood clot that had compressed the spinal cord. The resident was found liable for negligent care (“The proper medical standard is to evacuate the blood clot as quickly as possible. ... That is something that you are told in the first 2 weeks of your training”). However, the supervising neurosurgeon escaped liability, as the resident had not informed him of the clinical findings, and thus he could not have prevented the mishap (Parmelee v. Kline, 579 So.2d 1008 [La. App. 1991]).

Finally, the hospital may be vicariously liable for a resident’s negligence through the doctrine of respondeat superior if the resident is deemed an employee of the hospital. Whether residents are considered employees or students with respect to the hospital is debatable. The National Labor Relations Board, the Internal Revenue Service, and state courts are at odds over the definition. Although trainees clearly have an educational purpose in their work, courts have frequently ruled that they are hospital employees for purposes of ascertaining vicarious liability.

Dr. Tan writes the “Law & Medicine” column, which regularly appears inInternal Medicine News, an Elsevier publication. He is professor of medicine and former adjunct professor of law at the University of Hawaii, Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. It is adapted from the author’s book, “Medical Malpractice: Understanding the Law, Managing the Risk” (2006).

Subject Codes:
general_primary; womans_health; surgery; emergency_trauma;


http://www.imng.com


August 17, 2010   01:00 AM EDT

S.Y. Tan

By Sharon Worcester
Elsevier Global Medical News
Breaking News

The need for diabetes medication therapy is eliminated in the majority of obese type 2 diabetes patients who undergo bariatric surgery, findings from a retrospective time-series study of 2,235 patients suggest.

At 6 months after bariatric surgery, 75% of patients were off their diabetes medication, and at 1 and 2 years after surgery, 81% and 85%, respectively, were off their diabetes medication, Dr. Martin A. Makary and his colleagues at Johns Hopkins University, Baltimore, reported in the August issue of Archives of Surgery.

The effects were seen across all six classes of diabetes medication, with the greatest reductions in use occurring in patients taking metformin. About 53% of patients used metformin 3 months prior to surgery, and only 8% used metformin 1 year after surgery, the investigators found (Arch. Surg. 2010;145:726-31).

Factors independently associated with elimination of diabetes medication were younger age (odds ratios of 2.93 for those aged 18-34 years, 2.20 for those aged 35-44 years, and 1.76 for those aged 45-54 years, relative to those aged 55-64 years), male sex (OR 1.27), and Roux-en-Y gastric bypass procedure (OR 1.63 relative to gastric banding and other restrictive procedures).

Factors associated with reduced likelihood of discontinuing diabetes medication after surgery were the use of multiple diabetes medications preoperatively (OR 5.59 and 2.24 for those using one and two medications, respectively, and relative to using three or more medications), and the presence of diabetes complications (OR 1.45).

Patients in the study included adults from seven Blue Cross/Blue Shield health plans who underwent bariatric surgery between Jan. 1, 2002, and Dec. 31, 2005.

Overall, surgery was safe. The in-hospital mortality rate was 0.3%, and readmission rates were 7.5% within 30 days and 21% in 1 year, which is comparable to rates previously reported in the literature, the investigators said.

Dr. Makary and his colleagues used administrative claims data to assess use of diabetes medications and annualized health care costs at specified time intervals before and after surgery.

The improvements in health, as evidenced by the reduction or elimination of diabetes medication, were associated with a reduction in health-related costs; compared with the $6,376 annual cost observed in the 2 years prior to surgery, total annual health care costs per person increased by 9.7% ($616) in the first postoperative year, but they decreased by 34% ($2,179) in year 2, and by 71% ($4,498) in year 3. The median cost of surgery and related hospitalization was $29,959.

“We believe that the reduction in overall annual health care costs realized represents the improved health associated with successful therapy for obesity and type 2 diabetes,” they said. The findings corroborate those from previous reports from single institutions, and from recent studies showing that surgery resulted in greater likelihood of remission of type 2 diabetes than did conventional diabetes management, they noted.

“We found an improved long-term mortality rate in the bariatric surgery group, compared with the nonsurgical group (9% vs. 28%). Furthermore, the resolution of type 2 diabetes was sustained at 1 and 2 years after surgery,” they said. “Because weight loss following bariatric surgery has been observed to be sustained for decades, we believe that the protective effect against complications of diabetes is also likely to be long-term.”

Health care providers should consider discussing bariatric surgery with obese patients with type 2 diabetes, and health insurers – both private and public – should pay for bariatric surgery for appropriate candidates, they concluded.

Additional research is needed to evaluate the effects of bariatric surgery on preventing acute and chronic diseases, as well as on common operations, maternal and neonatal outcomes, and long-term health outcomes, they said.

The investigators reported having no financial disclosures.

Subject Codes:
top_stories; gastroenterology; diabetes; general_primary; endocrinology; surgery;


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August 16, 2010   04:00 PM EDT

Martin Makary

By Bruce Jancin
Elsevier Global Medical News
Breaking News

VAIL, Colo. (EGMN) – Acceptance of the pandemic 2009 H1N1 influenza vaccine by U.S. health care workers was, in a word, “terrible,” Dr. Adriana Weinberg declared.

A mere 37% of physicians and other health care workers were vaccinated against the pandemic virus, Dr. Weinberg reported at the annual conference on pediatric infectious diseases sponsored by the Children’s Hospital, Denver.

Uptake of the vaccine by two notably high-risk patient groups – pregnant women, and children and adolescents aged 6 months to 17 years – was equally poor at 38% and 37%, respectively, said Dr. Weinberg, professor of medicine, pediatrics, and pathology, and medical director of the clinical virology laboratory at the University of Colorado Hospital, also in Denver. These data were provided to the National Vaccine Advisory Committee by the Centers for Disease Control and Prevention.

Among parents and other care providers for infants less than 6 months of age, vaccine acceptance was even worse at 14%.

Moreover, only 25% of adults aged 24-64 years with immunosuppression or other chronic medical conditions placing them at elevated risk for increased flu morbidity got vaccinated. That was essentially the same rate as in the overall U.S. population, including both high-priority and non–high-priority individuals.

As a result of this low uptake, many millions of soon-to-expire doses of pandemic 2009 H1N1 influenza monovalent vaccine are being destroyed.

In several studies, the main reason cited by health care workers and pregnant women for not accepting the vaccine was fear of side effects, especially Guillain-Barré syndrome, which was an issue with the 1976 swine flu vaccine. The safety concerns proved baseless this time around, as evidenced by consistently reassuring findings from three separate sources: the Vaccine Safety Datalink, the Vaccine Adverse Event Reporting System, and the Emerging Infections Program.

For example, there were no deaths and no cases of Guillain-Barré syndrome among recipients of 438,376 doses of the vaccine in managed care organizations participating in the Vaccine Safety Datalink. And during surveillance for Guillain-Barré syndrome conducted through the Emerging Infections Program, the rate of cases was 1.92/100,000 person-years among vaccine recipients, compared with 1.21/100,000 person-years among nonrecipients. That 0.7/100,000 person-years excess of Guillain-Barré syndrome associated with the pandemic H1N1 vaccine is similar to that associated with the seasonal influenza vaccine, according to Dr. Weinberg.

One audience member said the reason lots more families in his practice didn’t get vaccinated against H1N1 wasn’t fear of side effects; it was that he and other office-based physicians in his community didn’t get shipments of the vaccine until after the second and as it turned out, final, wave of the 2009 pandemic had passed.

Dr. Weinberg agreed that lack of timely vaccine availability caused by long delays in the cumbersome manufacturing process was a huge problem. A potential solution would be to produce influenza vaccines in cell culture instead of eggs, something the Food and Drug Administration is very reluctant to allow, although one such flu vaccine was recently approved in Europe. Another answer would be to identify common epitopes that confer cross-strain protection against all influenza strains, so a new vaccine wouldn’t have to be created in advance of every flu season.

“There has been a big push on this. There are some good candidate epitopes emerging in the last year. We shall see,” the virologist said.

The vaccine being manufactured for the coming 2010-2011 flu season contains antigens for a pandemic 2009 H1N1 influenza virus as well as a seasonal influenza A H3N2 Perth 2009 virus and an influenza B Brisbane 2008 virus. The immunization schedule recommended by the CDC calls for a single dose of the vaccine for adults and children older than age 10 years. Children aged 6 months to 9 years are to receive two doses 21 days apart unless they are in the minority who received the pandemic H1N1 monovalent vaccine last season, in which case they are to get a single dose of the trivalent vaccine. Despite this recommendation, a recent randomized controlled trial concluded that a single dose may be sufficiently immunogenic in young children (JAMA 2010;303:37-46).

“We do anticipate circulation of the pandemic H1N1 strain in the next flu season, but I have to caution you that in the Southern Hemisphere, where influenza season is going on right now, there is very, very little pandemic H1N1. What predominates are the A H3N2 and the B Brisbane,” she said.

Dr. Weinberg disclosed serving as a consultant to MedImmune, Astellas, GlaxoSmithKline, and Merck and Co. Inc.

Subject Codes:
nephrology_urology; infectious; ophthalmology; orl; gastroenterology; OncologyEX; dermatology; pediatrics; H1N1; general_primary; endocrinology; womans_health; allergy; pulmonology; cardiology; rheumatology; surgery; neurology; emergency_trauma; gerontology;


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August 13, 2010   10:14 PM EDT

By Mitchel L. Zoler
Elsevier Global Medical News
Breaking News

STOCKHOLM (EGMN) – Bariatric surgery must expand to larger numbers of severely obese patients with complicated disease, but be cautious in patients with a body mass index below 35 kg/m² where surgery remains investigational, researchers advised in a presentation at the 11th International Congress on Obesity.

Bariatric surgery “should be the standard of care for patients with complex, morbid obesity, patients with a body mass index of 40 kg/m² or greater with related diseases, including type 2 diabetes, that respond to weight loss,” said Dr. John B. Dixon, head of obesity research at Monash University in Melbourne. “At the moment we have patients with BMIs of 45 or 50 who we don’t treat with surgery; that’s a crisis.”

In most of the world, less than 1% of patients undergo bariatric surgery even when they meet current standards for performing surgery: a BMI of at least 40 kg/m² or at least 35 kg/m² plus comorbidity. In Australia, which has “one of the highest uptakes of bariatric surgery in the world,” and in the United States as well, use of bariatric surgery in these patients doesn’t crack 2% of the target population, even though bariatric surgery is now recognized as very effective and safe, he said. Patients with BMIs of more than 45 kg/m² are “where lives are saved, people we can help now,�� Dr. Dixon said.

Although Dr. Dixon has run studies that helped pioneer use of gastric banding in patients with BMIs of 30-35 kg/m², he agrees with the statement earlier this year by the American Diabetes Association, which said there is “currently insufficient evidence to generally recommend surgery in patients with BMI of less than 35 kg/m² outside of a research protocol” (Diabetes Care 2010;33:S11-S61).

“We need better quality evidence before lowering the threshold for bariatric-metabolic surgery for lower BMI. We will need properly conducted randomized controlled trials, and benefits are likely to be less substantial than in the severely obese” patients, he said.

Dr. Dixon and his associates published in 2006 results from a study that randomized 80 patients with BMIs of 30-35 kg/m² and no comorbidities to gastric banding or a very low calorie diet, pharmacotherapy, and lifestyle change. After 2 years of follow-up, the surgery patients showed significantly better weight loss, resolution of metabolic syndrome, and quality of life (Ann. Intern. Med. 2006;144:625-33).

A second study reported 2 years later ran a similar design in 60 obese patients with type 2 diabetes and a BMI between 30 and 40 kg/m². Gastric banding led to a 73% remission rate of type 2 diabetes during 2-year follow-up compared with a 13% remission rate in control patients managed by lifestyle changes only (JAMA 2008;299:316-23).

Outcomes like these have led to modest uptake of bariatric surgery in patients with BMIs less than 35 kg/m², although generally no lower than a BMI of 33 kg/m², Dr. Dixon said.

“What we see in Australia is that patients who are approaching a BMI of 35 and have trouble controlling their weight and have type 2 diabetes are receiving surgery, about 95% by gastric banding,” he said in an interview. Some Australian surgeons are clearing interested patients for the procedure if they have a current BMI of 33 or 34 kg/m². But surgery cases with a BMI as low as 31 or 32 kg/m² “are extraordinary,” he added.

A concern at lower BMI is that the risk-benefit balance in favor of surgery shifts and makes surgery a somewhat less attractive option. “At a BMI of 31 kg/m² surgery may not be as good as when patients are bigger,” he said.

Medical coverage also helps determine the BMI when Australian patients undergo surgery. Public insurers and hospitals Down Under often balk at surgery even when a patient’s BMI is greater than 40 kg/m², Dr. Dixon said, and publicly-funded surgery in patients with BMIs below 35 kg/m² does not happen. Bariatric surgery on patients with a BMI less than 35 kg/m² needs private insurance, Dr. Dixon said.

Dr. Dixon said that he has served on speakers bureaus for Abbott, Bariatric Advantage, Eli Lilly, Merck, and Nestlé Australia; he has been a consultant to Allergan, Bariatric Advantage, Nestlé Australia, Scientific Intake, and SP Health; and has received research support from Allergan, Nestlé Australia, ResMed, and Scientific Intake.

Subject Codes:
gastroenterology; diabetes; general_primary; endocrinology; cardiology; surgery;


http://www.imng.com


August 12, 2010   12:55 PM EDT

John B. Dixon

By Doug Brunk
Elsevier Global Medical News

SAN DIEGO (EGMN) – When Dr. Jay Doucet was chosen to join a 17-member team of clinicians that provided trauma care to elite athletes during the 2010 Winter Olympics in Vancouver, he grew to appreciate the unique nature of this patient population.

“Most patients are typically interested in getting better,” Dr. Doucet said during a meeting on critical care medicine sponsored by the University of California, San Diego. “These kinds of athletes are more interested in getting back to their event and being competitive, which is a much different goal. They invest years of training, and their success may be determined on a particular day by fractions of an inch or a few fractions of a second.

“It was drilled in us repeatedly by the Olympic Committee that our mission was about the Olympic athletes, making them have the best possible games they could have. If they were miserable, then the Olympics were going to be a failure. It was important that they had the best circumstances in which to compete,” said Dr. Doucet, director of the surgical intensive care unit at the University of California, San Diego Medical Center.

Dr. Doucet’s team was assigned to Whistler, the site of all downhill skiing and sliding events, located about 85 miles northwest of Vancouver, B.C. The existing medical clinic at Whistler had no surgery capabilities, so in 2005 Dr. Doucet and other clinicians helped to design a mobile medical unit (MMU), a double-wide trailer equipped with a licensed blood bank, an operating room, and other state-of-the-art gear.

The MMU was placed on a gravel parking lot in Whistler’s Athlete’s Village, “a very secure area inside about three layers of security,” he recalled. “Nobody gets into Athlete’s Village without being very carefully vetted, because it’s considered such a sensitive target for terrorism.” Small inflatable blimps equipped with security cameras and snipers on the hillside served as constant reminders of efforts to protect the area.

Dr. Doucet said that the MMU had three goals: to manage patients with threatened life, limb, or organs; to manage seriously ill or injured patients should there be no road or air transport available; and to serve as a resource and provide capacity for treatment of patients in the event of a multiple-casualty event.

The MMU was also designed to serve as an acute resuscitation area for all Olympic family members and to serve as an ICU/postanesthesia care unit (PACU). The operating room required the capacity to perform burr holes, tracheotomy/tracheostomy, thoracotomy, trauma laparotomy, external fixation for stabilization, and insertion of shunts. “We were temporizing for damage control surgery and then we’d evacuate the patient to Vancouver,” Dr. Doucet said.

Trauma personnel included three 17-member teams. Each team worked 12-hour shifts for 10 days before being replaced by another team, and was made up of two trauma anesthesiologists, two general trauma surgeons, two orthopedic trauma surgeons, two emergency nurses, four OR nurses, four critical care/PACU nurses, and one respiratory therapist/anesthesia assistant.

Dr. Doucet’s 10-day assignment started on the first day of Olympic competition, 1 day after Georgian luge slider Nodar Kumaritashvili was killed on a practice run. “That cast quite a pall over a lot of things,” he said. “There have been six athletes killed in the Olympics in the modern era. Four of those were at the Winter Olympics: two in the luge and two in downhill skiing. So the speeds that are obtained and the fact that you’re tending to push the human body beyond the limits of tolerance are quite visible in the Winter Olympics.”

Over the course of the 2010 Winter Olympics, there were about 4,000 athlete visits to Olympic medical facilities. Keeping confidentiality was an ongoing challenge, Dr. Doucet said, as was following the stringent doping rules.

“Any medication you give them could potentially disqualify them,” he said. “It could alter a drug test or give them an unfair advantage, or could be accused of giving them an unfair advantage. Any medication you might think of giving a trauma patient – narcotics, vasopressors, diuretics – they’re almost all banned. When an injured patient came into the MMU, one of the first things you had to determine was, are they competing? Are they competing soon? If they are, what am I allowed to give them, and what waivers do I have to attend to?”

One-on-one consults with injured athletes were nearly impossible in this environment. “Elite athletes come with coaches, trainers, team officials, team doctors, and government officials,” he said. “Sometimes entire nations and media are paying very close attention to everything that athlete does. The scrutiny is quite intense.”

Slovenian cross-country skier Petra Majdic broke five ribs in a fall during a practice run, just minutes before her scheduled race. She went on to compete, however, and earned the bronze medal in the cross-country sprint. She collapsed at the finish line and was transported to the MMU for treatment of a pneumothorax. A chest tube was inserted, and after stabilization she still wanted to attend her medal presentation that evening. She received her bronze medal standing on the podium with her chest tube in place, flanked by MMU staff.

“That’s one tough lady,” Dr. Doucet said.

A few days after her race, Ms. Majdic returned to the MMU with gifts for the staff as a gesture of thanks.

From a practice standpoint, Dr. Doucet said he learned that with enough time, preparation, and good planning, “you can deliver high-quality trauma and critical care almost anywhere.”

He also learned that there was no room at the event for clinicians with supersized egos. “To work in organizations like this, you need to check your ego at the door,” he said. “If you’re a real prima donna, you’re not going to be able to function in this environment, because you’re not the most important person there. The athletes are.”

Subject Codes:
sports; surgery; emergency_trauma;


http://www.imng.com


August 12, 2010   02:00 AM EDT

Dr. Doucet poses for a photo with U.S. Olympic cross-country skier Holly Brooks.

By Mary Ellen Schneider
Elsevier Global Medical News

One new concept to come out of the health reform debate is the Accountable Care Organization (ACO). The concept builds off the idea of the patient-centered medical home and calls for primary care physicians, specialists, and hospitals to band together to provide high-quality care for patients. Under the ACO concept, payments would be linked to quality, and ACO providers would have the opportunity to share in any savings realized through better, more cost-effective care. Under the Affordable Care Act, Medicare will launch a shared savings program in 2012 to test the concept.

Dr. Lori Heim, president of the American Academy of Family Physicians, explains how these ACOs might work and what might drive their popularity.

EGMN: The AAFP has spent a lot of time promoting the concept of the patient-centered medical home and the medical home neighborhood. Is an ACO the next logical step?

Dr. Heim: The ACO builds on the foundation of a medical home based in primary care. Both have the same goals for the patient: coordinated care that ensures a seamless transition from one service to another and one level of care to another.

The core of an ACO is effective primary care with a focus on prevention, early diagnosis, chronic disease management, and other services delivered through primary care practices. We believe that in order to be successful, ACOs will require a robust network of practices founded in primary care. They may involve other primary care practices, subspecialists, and in some cases hospitals. Envision the ACO as an expanding circle of health professionals with the patient and the patient’s medical home in the center.

The ACO concept requires that medical-home practices commit to performance improvement and publicly reported performance results. ACOs are a formalization of the medical home neighborhood, which is essential for a medical home to realize its full potential. Thus, an ACO may be the next logical step for physicians whose practices offer a mix of services; however, isolated rural practices will have more barriers to overcome to become members of an ACO.

EGMN: What are the advantages and disadvantages of an ACO?

Dr. Heim: ACOs will improve information flow and communication. They will offer payment incentives designed to produce high-quality, patient-centered, efficient care. The problem areas are in aligning the financial incentives in a way that provides the best value to the patient.

Cost savings to support an ACO will come largely from reductions in three areas: inappropriate hospital admissions and readmissions, diagnostic testing and imaging, and subspecialist expenses.

One of the greatest challenges to implementing an ACO is managing the conflicts associated with the internal distribution of funds. So, while we’re likely to see improved referral patterns and communication that will provide seamless, high-quality health care, we also are likely to see tension as health communities move away from competition and toward cooperation and collaboration.

EGMN: In the future, will all physicians be part of an ACO?

Dr. Heim: Because this concept is so new, it’s hard to say. Decisions on organizing the delivery system will be local. We’re going to see considerable experimentation with different structural models, different financing models, and different approaches to sharing payment or system savings among all providers. The medical home is important because its performance can be quantified and compensated relative to the value it brings to the entire system.

The movement will likely begin in large and well-organized independent practice associations (IPAs), multispecialty groups, and integrated delivery systems. For efficiencies of scale, other physicians will first need to organize into groups that can assume performance risk (for quality and efficiency, not insurance risk) and contract with specialists, hospitals, and other providers to build out the ACO model that will be attractive to employers and insurers.

EGMN: What do physicians need to do now if they want to experiment with the ACO idea?

Dr. Heim: The first step is to become a high-performing practice by implementing medical procedures, protocols, and services, as well as quality improvement systems. The second step is to think about how physicians’ practices fit into a larger health care community to provide comprehensive, integrated care. Physicians need to know their options for organizing into groups to create or become a part of an ACO. They need to understand their options for, and the implications of, contracting with or being employed by hospitals.

Hospitals are strategically buying primary care and subspecialty practices in markets where ACOs are mostly likely to form in order to maintain a flexible posture for the future. It is important for us to examine future contracts in light of potential shared savings for ACO and other payment models, whether we remain in private practice and negotiate contracts, or consider becoming salaried physicians.

Dr. Heim is also a hospitalist at Scotland Memorial Hospital in Laurinburg, N.C.

Subject Codes:
health_care_reform; OncologyEX; mental_health; pediatrics; general_primary; womans_health; cardiology; surgery;


http://www.imng.com


August 10, 2010   12:59 PM EDT

Lori J. Heim

By M. Alexander Otto
Elsevier Global Medical News
Breaking News

Vertebroplasty provided quicker, stronger, and more durable pain relief from acute, osteoporotic vertebral compression fractures than did conservative pain management, judging from the findings of a randomized, open-label trial published online by the Lancet Aug. 10.

“In a subgroup of patients with acute [fractures] and persistent pain, percutaneous vertebroplasty is effective and safe,” concluded Dr. Caroline Klazen, a radiologist at St. Elisabeth Hospital in Tilburg, the Netherlands, and her colleagues (Lancet 2010 Aug. 10 [doi:10.1016/S0140-6736(10)60954-3]).

Two previous studies found no benefit for vertebroplasty compared with bed rest, analgesics, and other conservative measures, but both trials included patients with fractures of up to a year old (N. Engl. J. Med. 2009; 361:557-68; N. Engl. J. Med.2009;361:569–79).

The Lancet study pitted vertebroplasty against conservative treatment within a mean of 5.6 weeks of fracture symptom onset; vertebroplasty patients experienced greater pain relief initially and throughout the trial’s yearlong follow-up.

“Apparently,” vertebroplasty shortly after a fracture “is more effective for pain relief” than vertebroplasty performed months afterward, Dr. Klazen and her colleagues wrote.

Recruited from the radiology departments of six hospitals in the Netherlands and Belgium, 101 patients were randomized to vertebroplasty and 101 to conservative measures. Patients were at least 50 years old, and 69% were female.

All of the patients had radiologically confirmed compression fractures at or below thoracic vertebrae 5 with bone edema on magnetic resonance imaging and a minimum height loss of 15%.

They also had tenderness at the fracture level; bone density T scores at or below –1; back pain for 6 weeks or less; and a pain score of at least 5 on a 10-point visual analog scale (VAS), with 10 being the worst pain.

In the vertebroplasty group, fractures were injected with a mean volume of 4.1 mL polymethylmetacrylate bone cement under fluoroscopic guidance.

At 1 month, those injected with the bone cement had a mean reduction of 5.2 VAS points from baseline (95% CI, 5.88-4.72), compared with a mean reduction of 2.7 points (95% CI, 3.22-1.98) in those treated conservatively.

At 1 year, vertebroplasty subjects had a mean reduction of 5.7 VAS points from baseline (95% CI, 6.22-4.98); conservatively treated patients had a mean reduction of 3.7 points (95% CI, 4.35-3.05).

Vertebroplasty patients used significantly less pain-relieving medication at day 1, week 1, and month 1, but the difference in drug use was not significant at later stages of follow-up.

The authors noted that the intervention was not blinded, and that “knowledge of the treatment assignment might have affected patient responses to questions or radiologist assessments.”

Computed tomographic scanning found that cement leaked out of 97 of the 134 vertebral bodies injected in the 101 vertebroplasty subjects. “Most leaks were discal or into segmental veins; none were into the spinal canal,” the authors noted.

Cement deposited in a segmental pulmonary artery in one patient, but all cement leaks remained asymptomatic.

In a commentary, orthopedic surgeons Dr. Douglas Wardlaw, of Woodend Hospital in Aberdeen, Scotland, and Dr. Jan Van Meirhaeghe, of St. Jan General Hospital in Brugge, Belgium, noted that the study “lends support to the large body of medical opinion that vertebroplasty has a part to play in the management of the pain of vertebral compression fractures” (Lancet 2010 Aug. 10 [doi:10.1016/S0140-6736(10)61162-2]).

But they noted “an unexplained significant difference at baseline” in quality of life and disability measurements between the two groups that suggests “the control group might have been generally healthier than the vertebroplasty group.”

Dr. Klazen and her colleagues attributed the differences to chance.

Dr. Wardlaw and Dr. Van Meirhaeghe also noted that in the two previous studies that found no benefit for vertebroplasty, the comparators were sham treatments, not conservative pain management.

In one of the trials, the sham included injecting bupivacaine, a long-acting local anesthetic, into fractures, which itself might have brought relief, they wrote.

By using conservative pain management as a comparator, Dr. Klazen and her colleagues noted, vertebroplasty was tested against “the reference treatment and thus provides the clinician with directly applicable information about how to best treat the patient.”

Dr. Klazen and her colleagues reported no conflicts of interest. Their study was funded by ZonMw, a Dutch organization for health care research and innovation, and Cook Medical, makers of the bone cement used in the trial. Dr. Wardlaw and Dr. Van Meirhaeghe reported receiving consulting fees and travel and accommodation expenses from Medtronic Spinal and Biologics Europa BVBA for their role in the FREE balloon kyphoplasty trial.

Subject Codes:
top_stories; orthopaedics; general_primary; endocrinology; pain; womans_health; rheumatology; surgery; gerontology;


http://www.imng.com


August 09, 2010   06:30 PM EDT

By Mitchel L. Zoler
Elsevier Global Medical News
Breaking News

STOCKHOLM (EGMN) – Gastric bypass surgery produced safe weight loss and also normalized several metabolic indicators in 81 adolescents who were followed after their procedures for up to 2 years, according to Dr. Torsten Olbers.

“Laparoscopic Roux-en-Y gastric bypass is feasible and safe in adolescents and generally well tolerated, and produced major weight loss and also metabolic and quality of life improvements,” Dr. Olbers said at the 11th International Congress on Obesity. The patients had a body mass index of at least 40 kg/m², or at least 35 kg/m² with a comorbidity. Their average body mass index was 45.5 kg/m².

“At the onset, there was a lot of skepticism about the effects of this surgery” in adolescents. “Now we think it’s a matter of how we should use this surgery rather than if we should use it,” said Dr. Olbers, a bariatric surgeon and director of the Obesity Centre at Sahlgrenska University Hospital in Gothenburg. “Now we need to find out the best group to treat. I have no doubt that [bariatric surgery] will be used in adolescents. But we need to know that it’s safe long term. We need to follow these patients and launch other studies to evaluate gastric bypass in adolescents,” Dr. Olbers said.

Dr. John G. Kral commented in an interview, “The time has come for responsible, well-controlled surgery for refractory obese individuals after they reach skeletal maturity. It is unethical to wait [until an adolescent is 18] to intervene on morbid obesity.

“Long-term weight loss has been substantially better [with surgery] than with any other intervention,” said Dr. Kral, a bariatric surgeon and professor of surgery and medicine at the State University of New York Downstate Medical Center, Brooklyn.

The series reported by Dr. Olbers began in 2006, and involved 53 girls and 28 boys with an average age of 16.5 years; 1 patient was age 13 and 2 were age 14 at the time of surgery. The average weight of the participants before surgery was 133 kg (293 lb). All patients underwent psychiatric assessment before undergoing surgery.

Dr. Olbers and his associates performed Roux-en-Y gastric bypass for all the participants. This produced three perioperative complications: two patients who needed blood transfusions and one who developed a deep infection.

In addition, during the first year post surgery, two patients needed follow-up surgery for internal hernias, one needed surgery for adhesions, and nine patients reported occasional abdominal pain. Also during follow-up, three patients have needed psychiatric care, three have abused drugs, two attempted suicide, and two patients became pregnant unexpectedly. Fifty-five patients have been followed for at least 2 years after surgery.

Average body weight fell from 133 kg at baseline to 90 kg (198 lb) at 1 year, and remained at that level out to 2 years’ follow-up. Body mass index dropped to an average of 30 kg/m² after 1 year and held at that level out to 2 years.

Metabolic indicators showed improvement as well. At 1 and 2 years, there was a roughly 70% relative drop in fasting insulin levels, smaller but significant reductions in plasma glucose and hemoglobin A1c levels, and improved results on an oral glucose tolerance test.

Surgery also led to sizeable reductions in plasma triglyceride and low-density lipoprotein cholesterol levels, plus a significant rise in high-density lipoprotein cholesterol level. The patients had significant reductions in their systolic and diastolic blood pressures and normalization of their liver enzymes and two inflammatory markers, lymphocyte count and C-reactive protein level, at 1 year after surgery.

On the 36-Item Short Form Health Survey, the patients had significant improvements in all physical and mental domains, especially the physical domains. The data showed no evidence of problems with bone density following surgery, Dr. Olbers added.

The next step should be a trial in which adolescents who are candidates for gastric bypass surgery are randomized to either undergo surgery immediately or have surgery delayed until they reach age 18. Long-term outcomes would then be compared between the two groups, he said.

Dr. Olbers and Dr. Kral reported that they had no relevant disclosures.

Subject Codes:
gastroenterology; diabetes; pediatrics; endocrinology; surgery;


http://www.imng.com


August 06, 2010   03:21 PM EDT

Torsen Olbers