Summary Background Early results of the Stenting and Aggressive Medical Management for Preventing Recurrent stroke in Intracranial Stenosis trial showed that, by 30 days, 33 (14·7%) of 224 patients ...in the stenting group and 13 (5·8%) of 227 patients in the medical group had died or had a stroke (percentages are product limit estimates), but provided insufficient data to establish whether stenting offered any longer-term benefit. Here we report the long-term outcome of patients in this trial. Methods We randomly assigned (1:1, stratified by centre with randomly permuted block sizes) 451 patients with recent transient ischaemic attack or stroke related to 70–99% stenosis of a major intracranial artery to aggressive medical management (antiplatelet therapy, intensive management of vascular risk factors, and a lifestyle-modification programme) or aggressive medical management plus stenting with the Wingspan stent. The primary endpoint was any of the following: stroke or death within 30 days after enrolment, ischaemic stroke in the territory of the qualifying artery beyond 30 days of enrolment, or stroke or death within 30 days after a revascularisation procedure of the qualifying lesion during follow-up. Primary endpoint analysis of between-group differences with log-rank test was by intention to treat. This study is registered with ClinicalTrials.gov , number NCT 00576693. Findings During a median follow-up of 32·4 months, 34 (15%) of 227 patients in the medical group and 52 (23%) of 224 patients in the stenting group had a primary endpoint event. The cumulative probability of the primary endpoints was smaller in the medical group versus the percutaneous transluminal angioplasty and stenting (PTAS) group (p=0·0252). Beyond 30 days, 21 (10%) of 210 patients in the medical group and 19 (10%) of 191 patients in the stenting group had a primary endpoint. The absolute differences in the primary endpoint rates between the two groups were 7·1% at year 1 (95% CI 0·2 to 13·8%; p=0·0428), 6·5% at year 2 (–0·5 to 13·5%; p=0·07) and 9·0% at year 3 (1·5 to 16·5%; p=0·0193). The occurrence of the following adverse events was higher in the PTAS group than in the medical group: any stroke (59 26% of 224 patients vs 42 19% of 227 patients; p=0·0468) and major haemorrhage (29 13%of 224 patients vs 10 4% of 227 patients; p=0·0009). Interpretation The early benefit of aggressive medical management over stenting with the Wingspan stent for high-risk patients with intracranial stenosis persists over extended follow-up. Our findings lend support to the use of aggressive medical management rather than PTAS with the Wingspan system in high-risk patients with atherosclerotic intracranial arterial stenosis. Funding National Institute of Neurological Disorders and Stroke (NINDS) and others.
Background Expert panels of colorectal surgeons consistently rank anastomotic leak as among the most important quality metrics for colectomies. Nonetheless, most administrative and clinical databases ...do not collect data on anastomotic leaks and rely on reported organ space surgical site infections (OSI) as a proxy for identifying anastomotic leaks. This study questions the validity of using OSI as a surrogate for anastomotic leak. Methods The Upstate New York Surgical Quality Initiative (UNYSQI) is a collaboration of 12 hospitals that prospectively collects colectomy-specific metrics, including anastomotic leak, in addition to standard National Surgical Quality Improvement Program (NSQIP) data, including OSIs. Cases with an organ space infection and/or anastomotic leak were selected from the 2010–2011 UNYSQI database. Patient characteristics and outcomes were compared for cases with organ space infections and anastomotic leaks. Results Overall, 3% of colectomies had a reported organ space infection and 4% had an anastomotic leak. Among cases having anastomotic leaks, only 25% were also coded as having an organ space infection, leaving 75% of anastomotic leaks not captured by the NSQIP database (κ = 0.272; P ≤ .001). Conclusion Organ space infection is a poor surrogate for anastomotic leak, resulting in grossly underestimated leak rates and seemingly represents different postoperative courses. Procedure-specific quality measures for colorectal surgery should include data collection on anastomotic leaks to provide accurate data for use in improving patient care.
Background We evaluated left heart bypass (LHB) for spinal cord protection during aortic coarctation repair in patients with mild (primary, postsurgical, or intervention) and complex coarctation. ...Methods Between 1990 and 2008, 19 patients (mean age, 21 years; weight, 70 ± 16 kg) using LHB were compared with 27 patients (mean age, 16 years; weight, 65 ± 8 kg) undergoing coarctation repair without LHB (non-LHB). Follow-up was similar (LHB, 5 ± 4 vs non-LHB 4 ± 3 years; p = 0.81). Results Cohorts were similar in age and body surface area. No non-LHB patient lost somatosensory evoked potential or had a femoral artery pressure below 45 mm Hg with test clamping. LHB more often allowed graft interposition (18 of 19 95% vs non-LHB, 7 of 27 26%; p < 0.003) and a longer clamp time (LHB 44 ± 16 vs non-LHB 31 ± 12 minutes p < 0.003) without spinal cord ischemia. Two non-LHB patients had temporary spinal cord paresis. No early or late deaths occurred. Reintervention (LHB, 2 of 19 11% vs non-LHB, 2 of 27 7%; p = 0.82) and antihypertensive requirements were similar (LHB, 9 of 19 40% vs non-LHB, 8 of 27 30%; p = 0.35). The late peak transcoarctation gradient was 8 ± 6 mm Hg in the LBH cohort vs 18 ± 11 mm Hg in non-LBH patients ( p = 0.001). Conclusions Although the adequacy of spinal cord collateral assessment in coarctation repair is imperfect, no spinal cord ischemia occurred with coarctation repair and LHB. We recommend LHB in patients with mild or complex coarctation.
Aortic stenosis is a common disorder. Aortic valve replacement is indicated in symptomatic patients with severe aortic stenosis, as the prognosis of untreated patients is poor. Nevertheless, many ...patients pose a prohibitively high surgical risk and are not candidates for surgical valve replacement. Transcatheter aortic valve implantation (TAVI) is a novel method to treat selected high-risk patients with aortic stenosis. Patient screening and anatomic measurements of the aortic root are of great importance to ensure procedural success and appropriate patient selection. Multidetector computed tomography (CT) is playing an increasingly important role in patient screening protocols before TAVI, provides detailed anatomic assessment of the aortic root and valve annulus, assesses the suitability of iliofemoral access, and determines appropriate coaxial angles to optimize the valve implantation procedure. Additionally, CT is providing a greater understanding of medium-term valve durability and integrity. This review outlines an evolving role for CT angiography in support of a TAVI program and describe step by step how CT can be used to enhance the procedure and provide a practical guide for the utilization of CT angiography in support of a transcatheter aortic valve program.
Stereotactic ablative radiation therapy (SABR) is a guideline-specified treatment option for early-stage lung cancer. However, significant posttreatment fibrosis can occur and obfuscate the detection ...of local recurrence. The goal of this study was to assess physician ability to detect timely local recurrence and to compare physician performance with a radiomics tool.
Posttreatment computed tomography (CT) scans (n=182) from 45 patients treated with SABR (15 with local recurrence matched to 30 with no local recurrence) were used to measure physician and radiomic performance in assessing response. Scans were individually scored by 3 thoracic radiation oncologists and 3 thoracic radiologists, all of whom were blinded to clinical outcomes. Radiomic features were extracted from the same images. Performances of the physician assessors and the radiomics signature were compared.
When taking into account all CT scans during the whole follow-up period, median sensitivity for physician assessment of local recurrence was 83% (range, 67%-100%), and specificity was 75% (range, 67%-87%), with only moderate interobserver agreement (κ = 0.54) and a median time to detection of recurrence of 15.5 months. When determining the early prediction of recurrence within <6 months after SABR, physicians assessed the majority of images as benign injury/no recurrence, with a mean error of 35%, false positive rate (FPR) of 1%, and false negative rate (FNR) of 99%. At the same time point, a radiomic signature consisting of 5 image-appearance features demonstrated excellent discrimination, with an area under the receiver operating characteristic curve of 0.85, classification error of 24%, FPR of 24%, and FNR of 23%.
These results suggest that radiomics can detect early changes associated with local recurrence that are not typically considered by physicians. This decision support system could potentially allow for early salvage therapy of patients with local recurrence after SABR.
Objective The objective of the study was to examine the effect of selective fetoscopic laser photocoagulation (SFLP) vs serial amnioreduction (AR) on perinatal mortality in severe twin-twin ...transfusion syndrome (TTTS). Study Design This was a 5 year multicenter, prospective, randomized controlled trial. The primary outcome variable was 30 day postnatal survival of donors and recipients. Results There was no statistically significant difference in 30-day postnatal survival between SFLP or AR treatment for donors at 55% (11 of 20) vs 55% (11 of 20) ( P = 1.0, odds ratio OR 1, 95% confidence interval CI 0.242 to 4.14) or recipients at 30% (6 of 20) vs 45% (9 of 20) ( P = .51, OR 1.88, 95% CI 0.44 to 8.64). There was no difference in 30 day survival of 1 or both twins on a per-pregnancy basis between AR at 75% (15 of 20) and SFLP at 65% (13 of 20) ( P = .73, OR 1.62, 95% CI 0.34 to 8.09). Overall survival (newborns divided by the number of fetuses treated) was not statistically significant for AR at 60% (24 of 40) vs SFLP 45% (18 of 40) ( P = .18, OR 2.01, 95% CI 0.76 to 5.44). There was a statistically significant increase in fetal recipient mortality in the SFLP arm at 70% (14 of 20) vs the AR arm at 35% (7 of 20) ( P = .25, OR 5.31, 95% CI 1.19 to 27.6). This was offset by increased recipient neonatal mortality of 30% (6 of 20) in the AR arm. Echocardiographic abnormality in recipient twin Cardiovascular Profile Score is the most significant predictor of recipient mortality ( P = .055, OR 3.025/point) by logistic regression analysis. Conclusion The outcome of the trial did not conclusively determine whether AR or SFLP is a superior treatment modality. TTTS cardiomyopathy appears to be an important factor in recipient survival in TTTS.
To evaluate whether technetium-99 (
Tc)-labeled macroaggregated albumin (MAA) can predict subsequent yttrium-90 (
Y) distribution and imaging response in patients with hepatocellular carcinoma (HCC).
...Retrospective review was performed of records of 83 patients with HCC who underwent
Y glass microsphere radioembolization with
Tc-MAA single photon emission computed tomography (SPECT) and
Y positron emission tomography (PET)/CT between January 2013 and December 2014. Images were fused to segment the whole liver normal tissue (WLNT) and the largest tumors. Fused images were reviewed and analyzed for comparison of absorbed dose (AD) to tumors and WLNT as calculated from
Tc-MAA SPECT and from
Y PET/CT, subjective imaging comparison of
Tc-MAA SPECT and
Y PET for tumors and WLNT, and correlation of tumoral AD with response on follow-up CT.
Final analysis included 73 and 63 patients for WLNT and tumor
Tc-MAA/
Y correlation, respectively, and 62 patients for AD vs response.
Tc-MAA/
Y limit of agreement for each reviewer was viewed as clinically acceptable only for WLNT (-15 to 15 Gy). AD interreviewer variability was clinically acceptable for WLNT but was too broad for tumor. Mean tumor AD for objective response (78%) was 313 Gy vs 234 Gy for nonresponders. No threshold was found between tumor AD and response (P > .1). Catheter mismatch between
Tc-MAA and
Y had a direct impact on AD mismatch between the 2 image sets.
Tc-MAA was found to be a poor surrogate to quantitatively predict subsequent
Y AD to hepatocellular tumors.
Tc-MAA distribution correlated with
Y distribution in the normal hepatic parenchyma.
Abstract Objective To report the design and implementation of the first 3 years of enrollment of the Mayo Clinic Biobank. Patients and Methods Preparations for this biobank began with a 4-day ...Deliberative Community Engagement with local residents to obtain community input into the design and governance of the biobank. Recruitment, which began in April 2009, is ongoing, with a target goal of 50,000. Any Mayo Clinic patient who is 18 years or older, able to consent, and a US resident is eligible to participate. Each participant completes a health history questionnaire, provides a blood sample, and allows access to existing tissue specimens and all data from their Mayo Clinic electronic medical record. A community advisory board provides ongoing advice and guidance on complex decisions. Results After 3 years of recruitment, 21,736 individuals have enrolled. Fifty-eight percent (12,498) of participants are female and 95% (20,541) of European ancestry. Median participant age is 62 years. Seventy-four percent (16,171) live in Minnesota, with 42% (9157) from Olmsted County, where the Mayo Clinic in Rochester, Minnesota, is located. The 5 most commonly self-reported conditions are hyperlipidemia (8979, 41%), hypertension (8174, 38%), osteoarthritis (6448, 30%), any cancer (6224, 29%), and gastroesophageal reflux disease (5669, 26%). Among patients with self-reported cancer, the 5 most common types are nonmelanoma skin cancer (2950, 14%), prostate cancer (1107, 12% in men), breast cancer (941, 4%), melanoma (692, 3%), and cervical cancer (240, 2% in women). Fifty-six percent (12,115) of participants have at least 15 years of electronic medical record history. To date, more than 60 projects and more than 69,000 samples have been approved for use. Conclusion The Mayo Clinic Biobank has quickly been established as a valuable resource for researchers.
To the Editor: Atopic dermatitis (AD) is the most common inflammatory skin disease, affecting up to 20% of children in the United States, and is characterized by an increased susceptibility to ...cutaneous infections.1,2 One in 10 subjects with AD has difficulty clearing cutaneous infections with a host of viruses including herpes simplex, vaccinia, human papilloma, and/or molluscum contagiosum.1 This typically manifests as more extensive cutaneous and sometimes systemic disease and/or resistance to standard therapies.
Background The phosphatidylinositol 3-kinase/Akt/mammalian target of rapamycin (PI3K/Akt/mTOR) pathway plays a critical role in the growth and progression of colorectal cancer (CRC). The purpose of ...our study was 2-fold: (1) to determine the expression levels of several key components of this pathway, including p85α, Akt1, Akt2, p-mTORSer2448 , and p-p70S6KThr389 in CRCs; and (2) to correlate the expression of these proteins with cancer stage and location (left versus right side). Study Design Immunohistochemistry for p85α, Akt1, Akt2, p-mTORSer2448 , and p-p70S6KThr389 was performed on normal colon and CRCs from 154 patients. Results All proteins investigated were significantly overexpressed in CRCs compared with matched normal colonic tissue from the same patient (p < 0.0001). PI3K pathway component proteins were moderately correlated across normal and malignant colon tissues; correlations tended to be stronger in normal tissues as compared with the same correlations in cancers. Expression levels of p85α were significantly higher in stage IV cancers than in stage I to III cancers (p = 0.0005). p85α expression was also significantly increased in the adjacent normal colonic mucosa of patients with stage IV CRC compared with earlier stages (p = 0.003). Finally, expression of Akt1, Akt2, and p-p70S6KThr389 was higher in left-sided CRCs compared with CRCs in the right colon (p = 0.007, p = 0.0008, and p = 0.04, respectively). Conclusions The PI3K/Akt/mTOR pathway components, p85α, Akt1, Akt2, p-mTORSer2448 , and p-p70S6KThr389 are highly overexpressed in CRCs, providing the rationale for targeting this pathway therapeutically in CRC patients. The increased expression of p85α in the adjacent normal mucosa of stage IV patients suggests an important field defect, which may contribute to the growth and progression of these cancers.
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