Aneurysm-related mortality rates in the US AneuRx clinical trial.

BACKGROUND: The AneuRx (Medtronic) stent graft was approved by the FDA in September 1999. The purpose of this study was to ascertain the aneurysm-related mortality rate of a subgroup of the patient cohort from Medtronic's investigational premarket study. STUDY DESIGN: There were 931 study subjects, from 19 medical centers, who were followed for an average of 3.48 years. Abdominal aortic aneurysm (AAA)-related mortality rates were examined, using death certificates and medical records. RESULTS: The 1-month postimplant death rate was 1.61%. Not counting deaths related to the initial implant, there was an increase in the rate of AAA-related mortality after 3 years, from an average of 0.18% in the first 3 years to an average of 1.39% in years 4 and 5. CONCLUSIONS: Mortality in patients implanted with an AneuRx graft (as determined in this study) probably exceeds that of open procedure patients (based on medical literature) at some point in time, likely within 4 years after implant.

Cognitive functioning, retirement status, and age: results from the Cognitive Changes and Retirement among Senior Surgeons study.

BACKGROUND: Accurate assessment of cognitive functioning is an important step in understanding how to better evaluate both clinical and cognitive competence in practicing surgeons. As part of the Cognitive Changes and Retirement among Senior Surgeons study, we examined the objective cognitive functioning of senior surgeons in relation to retirement status and age. STUDY DESIGN: Computerized cognitive tasks measuring visual sustained attention, reaction time, and visual learning and memory were administered to both practicing and retired surgeons at annual meetings of the American College of Surgeons. Data from 168 senior surgeons aged 60 and older were compared with data from 126 younger surgeons aged 45 to 59, with performance below 1.5 standard deviations or more indicating a significant difference between the groups. RESULTS: Sixty-one percent of practicing senior surgeons performed within the range of the younger surgeons on all cognitive tasks. Seventy-eight percent of practicing senior surgeons aged 60 to 64 performed within the range of the younger surgeons on all tasks compared with 38% of practicing senior surgeons aged 70 and older. Forty-five percent of retired senior surgeons performed within the range of the younger surgeons on all tasks. No senior surgeon performed below the younger surgeons on all 3 tasks. CONCLUSIONS: The majority of practicing senior surgeons performed at or near the level of their younger peers on all cognitive tasks, as did almost half of the retired senior surgeons. This suggests that older age does not inevitably preclude cognitive proficiency. The variability in cognitive performance across age groups and retirement status suggests the need for formal measures of objective cognitive functioning to help surgeons detect changes in cognitive performance and aid in their decisions to retire.

Historical reminiscence: origin of the Greenfield filter.

The Greenfield filter was the result of collaboration between a surgeon and a petroleum engineer. Originally it was a component of a catheter management approach to massive pulmonary embolism. Industry support allowed further technical improvements and long-term patient followup studies.

Cognitive changes and retirement among senior surgeons (CCRASS): results from the CCRASS Study.

BACKGROUND: Because individuals age cognitively at different rates, there is considerable interest in ways to assure that older surgeons have the physical and mental stamina, coordination, reaction time, and judgment to provide appropriate care. To clarify potential relationships between cognitive changes related to aging, the decision to retire, and changes in patterns of surgical practice, this study aimed to identify specific parameters of cognitive change among senior surgeons. STUDY DESIGN: Computerized cognitive tasks measuring sustained attention, reaction time, visual learning, and memory were administered to 359 surgeons at the annual meetings of the American College of Surgeons over a 6-year period. A self-report survey was also administered to assess subjective cognitive changes and the status of surgical practice and retirement decisions. RESULTS: Expected age-related cognitive decline was demonstrated on all measures, although measured reaction time was notably better than age-appropriate norms. There was a marked relationship between self-reported subjective cognitive change and retirement status, but not to changes in surgical practice. There was no notable relationship, however, between subjective cognitive change and objective cognitive measures. There were marked relationships between age and retirement decision or status and between age and changes in surgical practice. CONCLUSIONS: These results suggest that although self-perceived cognitive changes play a role in the decision to retire, they are not related to objective measures of cognitive change, and are not reliable in the decision to retire. The development of readily accessible measures of cognitive changes related to aging may serve to assist decisions either to continue surgical practice or to retire.

Form and function of vena cava filters: how do optional filters measure up?

The function of vena cava filters, preventing pulmonary embolism while maintaining caval patency, is associated with the design. Several characteristics have been reported. This report evaluates retrievable filter designs in comparison with previously marketed designs with respect to efficacy and safety. Three inferior vena cava (IVC) filters (Gunther Tulip, Bard Recovery, and the Cordis OptEase) were compared on the basis of design characteristics associated with function, shape, number of trapping levels, and fixation. Adverse events reported in the literature and to the US Food and Drug Administration Manufacturers and User Facility Device Experience Database (MAUDE) were summarized. The major differences among device types include the fixation, the volume and number of trapping levels, and the amount of metal in the IVC. The MAUDE registry reported adverse events that had been hypothesized from the analysis of in vitro and in vivo testing. The Recovery and OptEase filters had the highest number of clinically important reports. From 12 to 57% were retrieved between 3 days and 11 months. Adaptations made to facilitate retrieval led to unacceptable sequelae. The small number removed, the length of time they are left in place, and the risks associated with retrieval suggest that optional filters may not be equivalent to approved permanent devices.

Surgeons outperform normative controls on neuropsychologic tests, but age-related decay of skills persists.

BACKGROUND: The present study was undertaken to determine if psychomotor and visual-spatial abilities improve as a result of surgical training or are enhanced at baseline in those individuals choosing a surgical career. METHODS: Medical students entering a surgical field and practicing surgeons performed a series of neuropsychologic tests. Performance was compared between surgeon groups, as well as with normative aged-matched controls. RESULTS: An age-related decline was noted in the performance of all exercises, with the medical student group outperforming the midcareer surgeons, who in turn outperformed the senior surgeons. Interestingly, however, all 3 groups significantly outperformed their normative control groups on some or all tasks. CONCLUSIONS: Improved visual memory and psychomotor performance compared with normative controls appears to be present at baseline rather than resulting from surgical training. Decline in performance with age is observed, however, and this should be considered when an older surgeon is learning new visually complex procedures.

Acute venous disease: venous thrombosis and venous trauma.

Acute venous disorders include deep venous thrombosis, superficial venous thrombophlebitis, and venous trauma. Deep venous thrombosis (DVT) most often arises from the convergence of multiple genetic and acquired risk factors, with a variable estimated incidence of 56 to 160 cases per 100,000 population per year. Acute thrombosis is followed by an inflammatory response in the thrombus and vein wall leading to thrombus amplification, organization, and recanalization. Clinically, there is an exponential decrease in thrombus load over the first 6 months, with most recanalization occurring over the first 6 weeks after thrombosis. Pulmonary embolism (PE) and the post-thrombotic syndrome (PTS) are the most important acute and chronic complications of DVT. Despite the effectiveness of thromboembolism prophylaxis, appropriate measures are utilized in as few as one-third of at-risk patients. Once established, the treatment of venous thromboembolism (VTE) has been defined by randomized clinical trials, with appropriate anticoagulation constituting the mainstay of management. Despite its effectiveness in preventing recurrent VTE, anticoagulation alone imperfectly protects against PTS. Although randomized trials are currently lacking, at least some data suggests that catheter-directed thrombolysis or combined pharmaco-mechanical thrombectomy can reduce post-thrombotic symptoms and improve quality of life after acute ileofemoral DVT. Inferior vena caval filters continue to have a role among patients with contra-indications to, complications of, or failure of anticoagulation. However, an expanded role for retrievable filters for relative indications has yet to be clearly established. The incidence of superficial venous thrombophlebitis is likely under-reported, but it occurs in approximately 125,000 patients per year in the United States. Although the appropriate treatment remains controversial, recent investigations suggest that anticoagulation may be more effective than ligation in preventing DVT and PE. Venous injuries are similarly under-reported and the true incidence is unknown. Current recommendations include repair of injuries to the major proximal veins. If repair not safe or possible, ligation should be performed.

Surgeon age and operative mortality in the United States.

OBJECTIVES: Although recent studies suggest that physician age is inversely related to clinical performance in primary care, relationships between surgeon age and patient outcomes have not been examined systematically. METHODS: Using national Medicare files, we examined operative mortality in approximately 461,000 patients undergoing 1 of 8 procedures between 1998 and 1999. We used multiple logistic regression to assess relationships between surgeon age (< or =40 years, 41-50 years, 51-60 years, and >60 years) and operative mortality (in-hospital or within 30 days), adjusting for patient characteristics, surgeon procedure volume, and hospital attributes. RESULTS: Although older surgeons had slightly lower procedure volumes than younger surgeons for some procedures, there were few clinically important differences in patient characteristics by surgeon age. Compared with surgeons aged 41 to 50 years, surgeons over 60 years had higher mortality rates with pancreatectomy (adjusted odds ratio [OR], 1.67; 95% confidence interval [CI], 1.12-2.49), coronary artery bypass grafting (OR, 1.17; 95% CI, 1.05-1.29), and carotid endarterectomy (OR, 1.21; 95% CI, 1.04-1.40). The effect of surgeon age was largely restricted to those surgeons with low procedure volumes and was unrelated to mortality for esophagectomy, cystectomy, lung resection, aortic valve replacement, or aortic aneurysm repair. Less experienced surgeons (< or =40 years of age) had comparable mortality rates to surgeons aged 41 to 50 years for all procedures. CONCLUSIONS: For some complex procedures, surgeons older than 60 years, particularly those with low procedure volumes, have higher operative mortality rates than their younger counterparts. For most procedures, however, surgeon age is not an important predictor of operative risk.

Medical liability-the crisis, the reality, and the data: the University of Michigan story.

BACKGROUND: This study describes, quantifies, and evaluates the University of Michigan Department of Surgery medical malpractice experience for the 1992 to 2002 period. The goal is to gain an understanding of what our claims experience has been, what services are highest risk, and where the financial exposure lies. STUDY DESIGN: The study analyzed 308 medical malpractice cases within the Department of Surgery from 1992 through 2002. RESULTS: There were 263 cases involving a single surgical service (defendant-only) and 70 shared cases involving multiple services. One hundred forty-four cases (47%) were settled with no payment to the plaintiff. Settlements for all cases totaled Dollars 38,718,254. The per-case expense (not including legal fees) was Dollars 125,708. Legal expenses for all cases totaled Dollars 5,356,588, averaging Dollars 17,391 per case. CONCLUSIONS: Understanding and sharing institutional data on medical malpractice is critical to developing effective strategies for managing malpractice risk. Although many institutions treat these data as proprietary and confidential, communication of this information generates a better understanding of the opportunities that are available for development and implementation of appropriate risk-management tools.

A role for interleukin-10 in the assessment of venous thromboembolism risk in injured patients.

BACKGROUND: Management of patients with multiple trauma requires prophylaxis for venous thromboembolism (VTE). This involves recognition of the physiologic factors that are associated with VTE risk. Currently, there is no effective strategy for risk assessment. The purpose of this study is to investigate the relationship of serum P-selectin and interleuken-10 (IL-10) with VTE as a possible physiologic marker. METHODS: Patients admitted to two trauma centers with an Injury Severity Score >/=9 had blood samples drawn and underwent duplex ultrasound scanning of the lower extremities before initiating prophylaxis at admission, on days 3 and 7, and weekly until discharge. Patients were prophylaxed according to institutional protocols. RESULTS: One hundred eighty-six patients were enrolled with a VTE incidence of 17.8%. The population was predominantly male (60%), with a mean age of 48 years. sP-selectin levels were not statistically different between the groups (64.4 versus 74.8 pg/mL). However, IL-10 was significantly lower in the VTE group at both the initial and subsequent blood draws (21 versus 165 ng/mL, p = 0.012). Further, the ratio of sP-selectin to IL-10 (3.92 versus 0.92, p = 0.014) was statistically higher in the VTE group at admission. CONCLUSION: An elevated sP-selectin to IL-10 ratio appears to be associated with the development of VTE in patients at high risk and may prove to be a useful clinical marker for this dreaded complication among trauma patients. Early recognition of this high-risk group improves the accuracy of the risk/benefit determination for prophylaxis and identifies a group in whom routine ultrasound screening would be cost-effective.

Osteomyelitis of the foot and toe in adults is a surgical disease: conservative management worsens lower extremity salvage.

OBJECTIVE: To characterize the national epidemiology of adult osteomyelitis (OM) and, using a single institutions' experience, test the hypothesis that early surgical therapy as compared with antibiotics alone results in an improved chance of wound healing and limb salvage. BACKGROUND: Foot and digit OM is a very common problem for which management is variable and for which few guidelines exist. METHODS: The Nationwide Inpatient Sample (NIS) and a single institution review from 1993 to 2000 form the basis of this study, using ICD-9CM codes for lower extremity foot and digit OM. Demographics, risk factors, and treatments were analyzed against the outcomes of a healed wound, limb salvage, and death. RESULTS: The NIS included 51,875 patients (incidence = 9/10,000 patients per year) with a mean age of 60 years, and 59% were men. The median length of stay decreased from 9 to 6 days (P < 0.001), but the average admission charge of 19,000 dollars did not significantly decrease over 7 years. Of these patients, 23% underwent a digit amputation and 8.5% suffered proximal limb loss. Single-institution analysis of 237 consecutive patients with OM confirmed a similar mean age (58 years), gender (67% men), and most presented with a foot or digit ulcer (56%). Wound healing was achieved in 56% and overall limb salvage was 80%. Decreased wound healing was associated with peripheral vascular occlusive disease (odds ratio, 0.4; 95% confidence interval, 0.2-0.8, P = 0.006) and preadmission antibiotic use (odds ratio, 0.2; 95% confidence interval, 0.05-1.1, P=0.07), while surgical debridement (odds ratio, 2.2; 95% confidence interval, 1.2-4.2, P = 0.02) was associated with increased healing. Limb salvage was improved with an arterial bypass (odds ratio, 3.9; 95% confidence interval, 1.1-14, P = 0.04), while preadmission solid organ transplant (odds ratio, 0.37; 95% confidence interval, 0.14-0.96, P = 0.04), peripheral vascular occlusive disease (odds ratio, 0.25; 95% confidence interval, 0.12-0.5, P = 0.001), and preadmission antibiotic use (odds ratio, 0.34; 95% confidence interval, 0.15-0.77, P = 0.009) were associated with greater limb loss. CONCLUSION: Digit OM is an expensive and morbid disease. Aggressive surgical debridement/digit amputation and selected use of arterial bypass should improve wound healing and limb salvage, respectively. In contrast, antibiotic therapy alone is associated with decreased wound healing and limb salvage.

Thoracic outlet decompression for subclavian vein thrombosis: experience in 71 patients.

HYPOTHESIS: There is a difference in outcomes when patients have neurogenic thoracic outlet syndrome in addition to subclavian vein thrombosis. METHODS: Analysis of a prospectively developed database, medical record review, and a patient questionnaire were used to summarize clinical experience from December 1990 to December 2001 on the basis of the patient's original evaluation. Patients were stratified on the presence (group 1) or absence (group 2) of additional neurogenic pathologic features. RESULTS: Of 928 patients evaluated for thoracic outlet syndrome, 71 underwent 73 operative procedures for subclavian vein obstruction. Men predominated (55%), and the mean age was 32 years. Group 1 (41%) had more preoperative disability, a higher incidence of persistent pain (24%), and less likelihood of returning to full activity compared with group 2 (67% vs 93%; P = .01). Catheter-directed thrombolysis was used in 65% of veins. Preoperative balloon angioplasty was used selectively (34%), and only 4% required stents. Supraclavicular decompression and venolysis were usually delayed 3 weeks to allow for healing of the venous endothelium. Complications included wound infection (3%) and postoperative hematoma (8%). CONCLUSIONS: Patients with isolated subclavian vein obstruction have a more favorable outcome relative to those with combined neurogenic and venous pathologic features. Decompression following thrombolysis should be delayed to reduce the incidence of postoperative complications.