Proving the value of simulation in laparoscopic surgery

OBJECTIVE: To assess the McGill Inanimate System for Training and Evaluation of Laparoscopic Skills (MISTELS) physical laparoscopic simulator for construct and predictive validity and for its educational utility. SUMMARY BACKGROUND DATA: MISTELS is the physical simulator incorporated by the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) in their Fundamentals of Laparoscopic Surgery (FLS) program. MISTELS' metrics have been shown to have high interrater and test-retest reliability and to correlate with skill in animal surgery. METHODS: Over 200 surgeons and trainees from 5 countries were assessed using MISTELS in a series of experiments to assess the validity of the system and to evaluate whether practicing MISTELS basic skills (transferring) would result in skill acquisition transferable to complex laparoscopic tasks (suturing). RESULTS: Face validity was confirmed through questioning 44 experienced laparoscopic surgeons using global rating scales. MISTELS scores increased progressively with increasing laparoscopic experience (n = 215, P < 0.0001), and residents followed over time improved their scores (n = 24, P < 0.0001), evidence of construct validity. Results in the host institution did not differ from 5 beta sites (n = 215, external validity). MISTELS scores correlated with a highly reliable validated intraoperative rating of technical skill during laparoscopic cholecystectomy (n = 19, r = 0.81, P < 0.0004; concurrent validity). Novice laparoscopists were randomized to practice/no practice of the transfer drill for 4 weeks. Improvement in intracorporeal suturing skill was significantly related to practice but not to baseline ability, career goals, or gender (P < 0.001). CONCLUSION: MISTELS is a practical and inexpensive inanimate system developed to teach and measure technical skills in laparoscopy. This system is reliable, valid, and a useful educational tool.     

Automatic quantification of right ventricular function with gated blood pool SPECT

BACKGROUND: Quantification of right ventricular (RV) function is clinically relevant for the risk stratification and follow-up of patients with a wide spectrum of disease. This can be achieved with electrocardiography-gated blood pool single photon emission computed tomography (GBPS). We aimed to evaluate the accuracy of the completely automatic QBS GBPS processing software as compared with equilibrium planar radionuclide angiography (RNA) and with a GBPS manual segmentation method (GBPS(35%)) for the measurement of global RV ejection fraction (EF), taking the first-pass RNA (FP-RNA) as the gold standard. In parallel, we compared the RVEF, RV end-diastolic volume (EDV), and RV end-systolic volume (ESV) provided by QBS and GBPS(35%). METHODS AND RESULTS: The population included 85 patients with chronic post-embolic pulmonary hypertension. Twenty-one patients were excluded because of unsuccessful FP-RNA. Intraobserver and interobserver RVEF, RVEDV, and RVESV reproducibilities encountered with planar RNA, QBS, and GBPS(35%) were similar and compared favorably with those calculated with FP-RNA for RVEF. Mean RVEF was different between all methods. RVEF calculated with FP-RNA was better correlated to QBS (r = 0.68) and GBPS(35%) (r = 0.70) than to planar RNA (r = 0.59). RVEDV and RVESV with QBS were lower than with GBPS(35%), by 29% +/- 14% and 36% +/- 13%, respectively. RVEDV and RVESV with QBS were highly correlated to corresponding GBPS(35%) values: r = 0.88 and r = 0.91, respectively. CONCLUSION: As opposed to FP-RNA, GBPS is highly successful for the quantification of RV function. Both QBS and GBPS(35%) provide RVEF values similarly well correlated to FP-RNA and performed better than planar RNA. RVEF, RVEDV, and RVESV provided by QBS and GBPS(35%) are highly correlated. All of these RV functional measurements require further validation versus a better gold standard before their accuracy can be established.     

Factors affecting increasing radiation dose for mammography in North Carolina from 1997 through 2001: an analysis of Food and Drug Administration annual surveys

RATIONALE AND OBJECTIVES: To determine which factors affected the increase in average glandular dose recorded at the annual US Food and Drug Administration Mammography Quality Standards Act inspections of mammography equipment in North Carolina from 1997 to 2001. MATERIALS AND METHODS: Average glandular dose, HVL, kVp, ambient light, luminance, equipment age, processing speed, and system speed for every mammography unit at all facilities in the state were collected by state inspectors. A mixed-effect model was used to assess the average changes of glandular dose over time and to identify the factors associated with these changes. RESULTS: There was a statistically significant increase in the average glandular dose in North Carolina in 1999, 2000, and 2001 when compared with the baseline year of 1997. Factors that were statistically significantly linked to this effect were changes in kVp, processing speed, and system speed. CONCLUSION: Average glandular dose for mammography has recently increased in North Carolina. This change is likely caused by changes in screen-film products and processing techniques.     

Adenosine sestamibi spect post-infarction evaluation (inspire) trial: a randomized,prospective multicenter trial evaluating the role of adenosine tc-99m sestamibi spect for assessing risk and therapeutic outcomes in survivors of acute myocardial infarction

BACKGROUND: Preliminary studies indicate that adenosine myocardial perfusion single photon tomography (SPECT) can safely and accurately stratify patients into low and high risk groups early after acute myocardial infarction (AMI). METHODS AND RESULTS: INSPIRE is a prospective, randomized multicenter trial which enrolled 728 clinically stable survivors of AMI. Following baseline adenosine sestamibi gated SPECT, patients were classified as low, intermediate or high risk based on the quantified total and ischemic left ventricular (LV) perfusion defect size (PDS). A subset of high risk patients with a LV ejection fraction > or =35% were randomized to a strategy of either intensive medical therapy or coronary revascularization. Adenosine SPECT was repeated at 6-8 weeks to determine the relative effects of anti-ischemic therapies on total and ischemic PDS (primary endpoint). All patients were followed for one year. The baseline demographic, clinical and scintigraphic characteristics of the study population are presented. Adenosine SPECT was performed within 1 day of admission in 12% of patients and in 64% by Day 4. CONCLUSION: The unique study design features of INSPIRE will further clarify the role of adenosine sestamibi SPECT in defining initial patient risk after AMI and in monitoring the benefits of intensive anti-ischemic therapies.     

PET with [18F]fluorothymidine for imaging of primary breast cancer: a pilot study

The aim of this study was to evaluate the use of [¹⁸F]fluorothymidine (FLT) as a positron emission tomography (PET) tracer for the diagnosis of breast cancer. To this end, 12 patients with 14 primary breast cancer lesions (T2–T4) were studied by FLT-PET. For comparison, [¹⁸F]fluorodeoxyglucose (FDG) PET scans were performed in six patients. Thirteen of the 14 primary tumours demonstrated focally increased FLT uptake (SUV_mean=3.4±1.1). Seven out of eight patients with histologically proven axillary lymph node metastases showed focally increased FLT uptake in the corresponding areas (SUV_mean=2.4±1.2). The lowest SUV (mean =0.7) was observed in one of two inflammatory cancers. The contrast between primary tumours or metastases and surrounding tissue was high in most cases. In direct comparison to FDG-PET, the SUVs of primary tumours (5/6) and axillary lymph node metastases (3/4) were lower in FLT-PET (SUV_FLT: 3.2 vs SUV_FDG: 4.7 in primary tumours and SUV_FLT: 2.9 vs SUV_FDG: 4.6 in lymph node metastases). Since FLT uptake in surrounding breast tissue was also lower, tumour contrast was comparable to that with FDG. It is of note that normal FLT uptake was very low in the mediastinum, resulting in a higher tumour-to-mediastinum ratio as compared to FDG (P=0.03). FLT-PET is suitable for the diagnosis of primary breast cancer and locoregional metastases. High image contrast may facilitate the detection of small foci, especially in the mediastinum.     

Left heart bypass during descending thoracic aortic aneurysm repair does not reduce the incidence of paraplegia

BACKGROUND: The preferred technique for spinal cord protection during surgical repair of descending thoracic aortic aneurysms (DTAAs) remains controversial. The purpose of this retrospective analysis was to determine if the use of left heart bypass (LHB) reduced the incidence of paraplegia in patients who underwent DTAA repair. METHODS: Over a 15-year period 387 consecutive patients underwent surgical repair of DTAAs using either the "clamp-and-sew" technique (341 patients, 88.1%) or distal aortic perfusion via a LHB circuit (46 patients, 11.9%). Data regarding patient characteristics, operative variables, and outcomes were retrieved from a prospectively maintained database. The impact of LHB on the frequency of paraplegia was determined using univariate and propensity score analyses. RESULTS: There were 17 operative deaths (4.4%) including 11 patients (2.8%) who died within 30 days. Paraplegia occurred in 10 patients (2.6%). On univariate analysis increasing age (p = 0.03), increasing aortic clamp time (p < 0.001), increasing red blood cell transfusion requirements (p = 0.01), and acute dissection (p = 0.03) were associated with increased incidence of paraplegia. Patients who received LHB had a similar incidence of paraplegia (2/46, 4%) compared with those treated without LHB (8/341, 2.3%; p = 0.3). Both matching and stratification propensity score analyses confirmed that LHB was not associated with reduced risk of paraplegia. CONCLUSIONS: On retrospective analysis the use of LHB during DTAA repair did not reduce the incidence of spinal cord injury. The "clamp-and-sew" technique remains an appropriate approach to DTAA repair.     

Survival in patients with peripheral vascular disease after percutaneous coronary intervention and coronary artery bypass graft surgery

Background

Patients with peripheral vascular disease (PVD) undergoing coronary revascularization have high rates of adverse outcomes. Whether there are important differences in outcomes for surgical versus percutaneous coronary revascularization is unknown. The objective of this study was to compare survival in patients with PVD who underwent percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) surgery for multivessel coronary artery disease.

Methods

In-hospital data were collected on 1,305 consecutive patients undergoing coronary revascularization (PCI, n = 341; CABG, n = 964) in northern New England from 1994 to 1996. Patient records were linked to the National Death Index to assess survival out to 3 years (mean 1.2 years). Logistic and Cox proportional hazards regression were used to calculate risk-adjusted odds ratios and hazard ratios.

Results

Compared with CABG patients, those undergoing PCI were more often women, had more renal failure, more prior coronary revascularizations, were more likely to have two-vessel coronary artery disease and were more likely to undergo the procedure emergently. They were less likely to have a history of heart failure. After adjusting for differences in baseline characteristics, patients undergoing CABG had better intermediate survival than did PCI patients (hazard ratio 0.68; 95% confidence interval, 0.46 to 1.00; p = 0.05).

Conclusions

Patients with multivessel coronary artery disease and PVD undergoing CABG surgery have better intermediate survival out to 3 years than similar patients undergoing PCI. This information may be useful in counseling patients with PVD requiring coronary revascularization.     

Subintimal angioplasty for infrainguinal occlusive disease

Subintimal angioplasty is a relatively new endovascular approach for the treatment of patients with femoropoliteal or tibial artery occlusion. The procedure involves intentionally creating a false channel or dissection around an arterial occlusion, then reentering the true lumen distally. The procedure has a relatively low incidence of complications and a high rate of technical success.Short-term patency has been fair in some reports and poor in others. Long-term results are not available. Aspirin and possibly anticoagulation or antiplatelet agents may improve technical success and short-term patency. Further studies with longer follow-up are required before it can be recommended as a potentially viable alternative to arterial bypass.     

Angiogenic pretreatment improves the efficacy of cellular cardiomyoplasty performed with fetal cardiomyocyte implantation

BACKGROUND: Cell implantation into areas of myocardial infarction (cellular cardiomyoplasty) may be limited in efficacy because of the lack of blood supply to these areas of myocardium, resulting in early loss of transplanted cells. We therefore tested the hypothesis that pretreatment of infarcted myocardium with angiogenic therapy, followed by cell transplant, would be more effective than the application of either strategy alone. METHODS: Fischer 344 rats underwent left coronary artery ligation and injection of an adenovirus encoding VEGF 121, an empty expression cassette control vector, or saline solution. Capillary density in the infarcted region was determined in preliminary studies. Cardiomyocytes harvested from syngeneic Fischer rat fetuses were prelabeled and then injected directly into the infarct area 3 weeks after vector administration. Exercise treadmill testing was performed 2 weeks after cell transplantation, after which a cell viability index was calculated as the number of implanted (prelabeled) nuclei divided by the number of coadministered microspheres detected in sections of implanted myocardium. RESULTS: Capillary density in the area of infarction was significantly greater in adenovirus encoding VEGF 121 compared with rats injected with saline solution (P =.001). The cell survival index was also greater in adenovirus encoding VEGF 121 compared with animals injected with empty expression cassette control or saline solution (P =.0045). Exercise tolerance was nearly doubled in animals receiving adenovirus encoding VEGF 121 3 weeks prior to cell implantation compared with animals receiving adenovirus encoding VEGF 121 or cells alone or those receiving adenovirus encoding VEGF 121 at the time of cell implantation (P <.001). CONCLUSIONS: Pretreatment of an infarcted region of the heart with angiogenic mediators such as VEGF can enhance the efficacy of cellular cardiomyoplasty, presumably by creating a more favorable environment for the survival of transplanted cells.