Early survival benefit of a low-profile endograft in blunt traumatic aortic injury.

OBJECTIVE: The aim of this study was to demonstrate the safety and effectiveness of a low-profile thoracic endograft (19-23 French) in subjects with blunt traumatic aortic injury. METHODS: A prospective, multicenter study assessed the RelayPro thoracic endograft for the treatment of traumatic aortic injury. Fifty patients were enrolled at 16 centers in the United States between 2017 and 2021. The primary endpoint was 30-day all-cause mortality. RESULTS: The cohort was mostly male (74%), with a mean age of 42.4 ± 17.2 years, and treated for traumatic injuries (4% Grade 1, 8% Grade 2, 76% Grade 3, and 12% Grade 4) due to motor vehicle collision (80%). The proximal landing zone was proximal to the left subclavian artery in 42%, and access was primarily percutaneous (80%). Most (71%) were treated with a non-bare stent endograft. Technical success was 98% (one early type Ia endoleak). All-cause 30-day mortality was 2% (compared with an expected rate of 8%), with an exact two-sided 95% confidence interval [CI] of 0.1%, 10.6% below the performance goal upper limit of 25%. Kaplan-Meier analysis estimated freedom from all-cause mortality to be 98% at 30 days through 4 years (95% CI, 86.6%-99.7%). Kaplan-Meier estimated freedom from major adverse events, all-cause mortality, paralysis, and stroke, was 98.0% at 30 days and 95.8% from 6 months to 4 years (95% CI, 84.3%-98.9%). There were no strokes and one case of paraplegia (2%) during follow-up. CONCLUSIONS: RelayPro was safe and effective and may provide an early survival benefit in the treatment of blunt traumatic aortic injury.

Development and Evaluation of an Enhanced Recovery Protocol to Reduce Length of Stay following Elective Endovascular Aneurysm Repair.

BACKGROUND: Elective endovascular abdominal aortic aneurysm repair (EVAR) can be performed safely with a short postoperative length of stay (LOS). We aimed to develop and assess the impact of an enhanced recovery protocol (ERP) on LOS after elective EVAR. METHODS: Pre-ERP development single center retrospective review of elective EVAR procedures from January 2012 to December 2019. ERP was developed by targeting factors associated with prolonged LOS (>2 days) elucidated from semistructured interviews and Bayesian additive regression tree analysis. Post-ERP development, a subsequent retrospective review of elective EVAR performed from January 2018 to June 2021 was performed to evaluate LOS before and after ERP. Primary outcome was LOS. RESULTS: Two hundred sixteen patients underwent elective infrarenal EVAR from 2012 to 2019. Periprocedural factors identified as associated with LOS >2 days included noncommercial insurance (43.6% vs. 26.5%; P = 0.01), preoperative anemia (hemoglobin 12.56 g/dL vs. 13.57 g/dL; P = 0.001), worse renal function (creatinine 1.31 mg/dL vs. 1.01/dL; P = 0.004), open femoral access (74.4% vs. 26.5%; P < 0.001), intensive care unit (ICU) stay (2.7 days vs. 0.9 days; P < 0.001), postoperative anemia (9.8 g/dL vs. 11.9 g/dL; P < 0.001), postoperative creatinine (1.55 mg/dL vs. 0.97 mg/dL; P < 0.001), and beta blocker need on discharge (45.5% vs. 25%; P = 0.003) as significant between patients with short and prolonged LOS groups. Semistructured interviews revealed postoperative day 1 complete blood count/chemistry, postoperative physical therapy evaluation, ICU admission, urinary retention, patient expectations, and unavailability of transportation home as modifiable factors that delayed early discharge. A 14-component ERP was created to target the factors identified from combined qualitative and quantitative results. Post-ERP development, 74 elective EVAR patients were reviewed from 2018 to 2021 (37 pre-ERP and 37 post-ERP). Following ERP development, the mean LOS was reduced from 2.6 (standard deviation: 1.9) to 1.3 days (standard deviation: 1.3); P < 0.01. There were no significant differences in 30-day readmission, postoperative complications, emergency room visits, or 90-day mortality before and after the ERP was used. CONCLUSIONS: Practice and procedural factors can be modified through an informed and safe process to reduce LOS after elective EVAR. LOS following elective EVAR was safely reduced following the use of a systematically developed ERP.

Evidence Based Strategies in the Management of Localized Prostate Cancer and the Role of Brachytherapy.

Prostate cancer management is a critical component of men's health with ongoing controversies in screening and treatment. The purpose of this manuscript is to review contemporary evidence-based strategies in the management of localized prostate cancer to optimize patient outcomes, satisfaction, and shared decision making, to improve physician education and awareness, and to emphasize the importance of brachytherapy in the curative management of prostate cancer. The Bottom Line: 1. Selective screening and selective treatment reduces prostate cancer mortality rates. 2. Active surveillance is recommended for low risk prostate cancer. 3. Both radiation and surgery are appropriate options for patients with intermediate-risk and high-risk prostate cancer. 4. Quality of life and patient satisfaction favors brachytherapy for sexual function and urinary incontinence and surgery for urinary bother. 5. For patients with intermediate risk prostate cancer, brachytherapy achieves very high cure rates, acceptable sided effects, high patient satisfaction and is the most cost-effective treatment. 6. For patients with unfavorable intermediate-risk and high-risk prostate cancer, the combination of external beam radiation, brachytherapy, and ADT (Androgen Deprivation Therapy) achieves the highest rates of biochemical control and the lowest need for salvage therapies. 7. A collaborative shared decision making (SDM) process yields a well-informed, high-quality decision that is consistent with patients' preferences and value.

18F-fluciclovine-PET/CT imaging versus conventional imaging alone to guide postprostatectomy salvage radiotherapy for prostate cancer (EMPIRE-1): a single centre, open-label, phase 2/3 randomised controlled trial.

BACKGROUND: Molecular imaging is increasingly used to guide treatment decisions and planning in prostate cancer. We aimed to evaluate the role of 18F-fluciclovine-PET/CT in improving cancer control compared with conventional imaging (bone scan and either CT or MRI) alone for salvage postprostatectomy radiotherapy. METHODS: In EMPIRE-1, a single-centre, open-label, phase 2/3 randomised controlled trial, patients with prostate cancer with detectable PSA after prostatectomy and negative conventional imaging (no extrapelvic or bone findings) were randomly assigned in a 1:1 ratio to radiotherapy directed by conventional imaging alone or to conventional imaging plus 18F-fluciclovine-PET/CT. Computer-generated randomisation was stratified by PSA concentration, adverse pathology indicators, and androgen deprivation therapy intent. In the 18F-fluciclovine-PET/CT group, radiotherapy decisions were rigidly determined by PET findings, which were also used for target delineation. The primary endpoint was 3 year event-free survival, with events defined as biochemical or clinical recurrence or progression, or initiation of systemic therapy, using univariate and multivariable analyses in patients who received radiotherapy. This trial is registered with ClinicalTrials.gov, NCT01666808 and is closed to new participants. FINDINGS: From Sept 18, 2012, to March 4, 2019, 165 patients were randomly assigned, with median follow-up of 3·52 years (95% CI 2·98-3·95). PET findings resulted in four patients in the 18F-fluciclovine-PET/CT group having radiotherapy aborted; these patients were excluded from survival analyses. Median survival was not reached (95% CI 35·2-not reached; 33% of 81 patients had events) in the conventional imaging group compared with not reached (95% CI not reached-not reached; 20% of 76 patients) in the 18F-fluciclovine-PET/CT group, and 3 year event-free survival was 63·0% (95% CI 49·2-74·0) in the conventional imaging group versus 75·5% (95% CI 62·5-84·6) for 18F-fluciclovine-PET/CT (difference 12·5; 95% CI 4·3-20·8; p=0·0028). In adjusted analyses, study group (hazard ratio 2·04 [95% CI 1·06-3·93], p=0·0327) was significantly associated with event-free survival. Toxicity was similar in both study groups, with the most common adverse events being late urinary frequency or urgency (37 [46%] of 81 patients in the conventional imaging group and 31 [41%] of 76 in the PET group), and acute diarrhoea (11 [14%] in the conventional imaging group and 16 [21%] in the PET group). INTERPRETATION: Inclusion of 18F-fluciclovine-PET into postprostatectomy radiotherapy decision making and planning significantly improved survival free from biochemical recurrence or persistence. Integration of novel PET radiotracers into radiotherapy decisions and planning for prostate cancer patients warrants further study. FUNDING: National Institutes of Health/National Cancer Institute, Blue Earth Diagnostics, and Winship Cancer Institute of Emory University.

A Single Center 8 Year Experience of Segmental Arterial Mediolysis Management.

OBJECTIVE: Segmental Arterial Mediolysis (SAM) is a rare, poorly understood vasculopathy that involves vacuolization of the arterial wall, most commonly of the visceral arteries. There are no established therapeutic or monitoring guidelines for SAM, and intervention typically depends on patient presentation. The purpose of this study is to review the management and outcomes of patients with this rare vascular disease METHODS: Single center retrospective review of patients diagnosed with SAM between 2011 and 2019. Included were patients with radiological diagnosis of SAM. Demographic factors, past medical history, presenting symptoms, affected vessels, management, and lesion characteristics over time were collected. Demographic and periprocedural factors, and medical management strategies were compared for those who required operative intervention versus those managed non-operatively. RESULTS: Thirty patients were included, 21 (70%) were male, mean age was 53.5 years (range: 35.7-72.2). Twenty-seven patients were managed non-operatively, 3 patients required surgical intervention. Patients who underwent operative intervention were more likely to present with pain >30 days (P < 0.05), and hemorrhage (P < 0.01). Abdominal pain was the most common presenting symptom (n = 24, 80%). Arterial dissection was the most common radiological finding at time of presentation (n = 20, 67%). The celiac artery and its branches were most often involved (n=22, 73%) followed by the superior mesenteric artery and its branches (n = 15, 50%). Non-operative management most often consisted of anti-hypertensive therapy (n = 13, 43%), antiplatelet agents (n = 17, 57%%), and lipid-lowering agents (n = 13, 43%), with 7 patients receiving all three. Six patients demonstrated confirmed resolution of lesions during surveillance imaging, with average time to resolution of 325.5 days. CONCLUSIONS: Patients who underwent intervention for SAM presented with either mesenteric ischemia or pseudoaneurysm rupture. In patients that present without those conditions, medical management consisting of anti-hypertensives, antiplatelet agents, and lipid-lowering therapy was effective. Non operative management resulted in symptom resolution in all patients and surveillance imaging showed resolution of radiographic abnormalities in 6 patients out of 27 at less than one year.

Endovascular stenting of supra-aortic lesions using a transcarotid retrograde approach and flow reversal: A multicenter case series.

OBJECTIVE: Endovascular treatment has largely replaced open reconstruction of proximal brachiocephalic and left common carotid ostial arterial stenoses. The objective of this study was to report the technical feasibility and safety of a flow-based embolic protection system in stenting of single and tandem stenotic lesions of supra-aortic arch vessels. METHODS: All cases used flow-based neuroprotection by the ENROUTE Transcarotid Neuroprotection System (Silk Road Medical, Sunnyvale, Calif). Case specifics, such as the stents used, the details of flow-based neuroprotection, the order in which lesions were treated, and the case-specific exceptions, are detailed in the body of the publication. The primary end point of this study was the occurrence of stroke or transient ischemic attack. RESULTS: Sixteen patients (12 women) with an average age of 68 years (range, 54-83 years) underwent endovascular stenting to treat single (11 patients) or tandem (5 patients) stenotic lesions of supra-aortic arch vessels. A total of 21 lesions were treated: 7 in the innominate artery, 1 in the right common carotid artery, 8 in the left common carotid artery, and 5 in the internal carotid artery (tandem cases). Eleven patients (69%) were symptomatic, and the stenoses of the five asymptomatic patients were identified during routine workup for comorbidities. Technical success was obtained in all cases. There were no strokes or transient ischemic attacks during the 30 days after the procedure. Minor complications included a minor wound dehiscence that healed secondarily without sequelae and a hematoma at the neck incision that resolved spontaneously without further intervention. CONCLUSIONS: The use of a transcarotid retrograde approach with flow-based neuroprotection is technically feasible for the endovascular stenting of single and tandem stenotic lesions of the supra-aortic arch vessels. These data further support the advantages of a transcarotid approach and flow-based neuroprotection to minimize the risk of intraoperative complications and embolic events during and after the procedure.

Unplanned 30-day readmissions after endovascular aneurysm repair: An analysis using the Nationwide Readmissions Database.

BACKGROUND: Endovascular aneurysm repair (EVAR) is the preferred method for addressing abdominal aortic aneurysms (AAAs), with proven reduction in perioperative morbidity and mortality. There are, however limited data examining the readmissions after EVAR that are associated with increased patient morbidity and cost. As EVAR use continues its dominance in the management of AAAs, it becomes imperative to identify and mitigate risk factors associated with unplanned hospital readmissions. METHODS: The Nationwide Readmissions Database (NRD) was queried for all 30-day readmissions after an index EVAR procedure from 2012 to 2014. Preoperative patient demographics, hospital characteristics, readmission diagnosis, and costs were compared between those who were and were not readmitted within 30 days of the index operation. Multivariable logistic regression was used to identify potential risk factors associated with unplanned readmissions within 30 days. RESULTS: We identified 120,646 patients who underwent an EVAR from 2012 to 2014 in the United States. The overall unplanned readmission rate during this period was 11.6% (n = 14,073) within 30 days of the index EVAR procedure. The readmission rate was the highest in 2012, with a rate of 12.3% (P = .02). Multivariate regression analysis showed that EVAR readmissions were significantly higher in patients who were of younger age (18 to 49 years) compared with other age groups (odds ratio [OR], 1.9-2.17; P < .001), female sex (OR, 1.367; P < .001), had Medicare (OR, 1.39) or Medicaid (OR, 1.25) insurance, or a combination of these. Underlying patient comorbidities significantly associated with readmissions included congestive heart failure (OR, 2.4), peripheral vascular disease (OR, 1.1), chronic pulmonary disease (OR, 1.2), cancer with no metastasis (OR, 1.5), metastatic cancer (OR, 2.2), renal failure (OR, 1.8), and diabetes (OR, 1.5). CONCLUSIONS: The trend in 30-day readmission rates after EVAR has decreased slightly since 2012, but overall rates are at 11.6%, which is not insubstantial. Patient factors strongly associated with hospital readmission were younger age and patient comorbidities, including congestive heart failure, concurrent cancer diagnosis, renal failure, and diabetes.

Outcomes and Cost Comparison of Percutaneous Endovascular Aortic Repair versus Endovascular Aortic Repair With Open Femoral Exposure.

BACKGROUND: The objective of this study was to assess cost differences between patients who underwent percutaneous endovascular aortic repair (PEVAR) and open surgical femoral exposure in elective endovascular aortic repair (EVAR) of abdominal aortic aneurysms. MATERIALS AND METHODS: An IRB-approved single center retrospective analysis of patients who underwent elective EVAR for abdominal aortic aneurysms from 2009 to 2016 was performed. One hundred patients were selected with 50 patients who underwent PEVAR and 50 patients who underwent open surgical femoral exposure. Patient demographics, procedural variables, and hospital outcomes were collected and compared. Primary outcomes assessed used in cost calculations included operating time (OR time), hospital length of stay (LOS), and intensive care unit stay (ICU LOS). Extrapolated cost differences were based on known, published cost multipliers for the primary outcomes observed. RESULTS: Patients undergoing PEVAR had significant reduction in mean OR time (113.9 min versus 144.9 min, P < 0.001), mean ICU LOS (19.7 h versus 28.9 h, P = 0.094), and overall LOS (28.3 h versus 33.1 h, P = 0.020). There was no statistically significant difference in access related complications, although there was a trend toward less complication rates with PEVAR (0% versus 5%, P = 0.056). Calculated cost of procedures based on mean ICU LOS, hospital LOS, and OR time, showed significant reduction in mean hospital costs with PEVAR ($16,628.5 versus $21,705.8, P < 0.001). Multiple linear regression analysis demonstrated an overall 23% cost reduction with PEVAR. CONCLUSIONS: Prior reports comparing PEVAR versus EVAR with open femoral exposures have shown improvement in overall patient time to ambulation and other hospital metrics such as LOS with PEVAR. There is, however, a paucity of overall cost comparison data regarding PEVAR. In this study, adoption of PEVAR was seen to significantly reduce OR times (19%) and overall hospital LOS (50%). The outcomes observed ultimately translated into significant reduction in hospital costs.

Evolving Trends in Insurance Coverage of Vascular Surgery Patients in Academic Practice.

BACKGROUND: Insurance coverage of vascular surgery patients may differ from patients with less chronic surgical pathologies. The goal of this study is to identify trends in insurance status of vascular surgery patients over the last 10 years at a busy academic center. METHODS: All consecutive patient visits for a vascular procedure from 2006 to 2016 were retrospectively reviewed from a prospectively collected institutional database. Data points included insurance status, procedures performed, and date of admission. The insurance status was categorized as Medicare, Medicaid, and uninsured. Samples were divided between 2006-2009 and 2011-2016 for comparison. Unpaired t-test, chi-squared test, and regression analysis were used to determine significant trends over the study period. RESULTS: From 2006 to 2016, 6,007 vascular surgery procedures were performed. Procedure volume increased significantly from 1,309 to 4,698 between the 2 timeframes (P < 0.05), whereas the percentage of Medicaid and Medicare patients trended upward but did not achieve significance. There was a significant decrease in the percentage of uninsured patients between the cohorts (5.65% vs. 2.96%, P < 0.05). In 2012, 10.14% of patients were uninsured compared with 2.56% in 2016 (P < 0.05). CONCLUSIONS: Insurance status affects access to care and subsequent outcomes. In our busy academic center, insurance coverage for vascular surgery has significantly increased over the past decade. The number of Medicaid and Medicare patients has slowly increased, but a significant and continuing decline in uninsured patients was observed. Implementation of the Affordable Care Act during this time period may have played a role in providing coverage for patient needing vascular surgery.

Sex-dependent outcomes following elective endovascular aortic repair.

BACKGROUND: Evidence has shown that women derive less benefit from endovascular aortic repair (EVAR) in large part due to more challenging aortoiliac anatomy. This study sought to examine whether sex-dependent outcomes exist following elective EVAR cases. METHODS: An institutional retrospective review was performed on patients who underwent elective EVAR procedures between 2008 and 2014. Outcome data collected included procedural and hospital morbidity, mortality, and overall EVAR durability based on the incidence of unplanned graft-related secondary interventions (SIs) (e.g., open conversion, proximal or distal extensions, and coil embolizations). RESULTS: One hundred eighty-one patients (150 men, 31 women) met the study inclusion criteria. Median follow-up was 40.3 mo. Women had more challenging anatomy compared to men including smaller overall iliac diameters (6.8 mm versus 8.0 mm, P < 0.001) and more severe iliac angulation (77% moderate to severe versus 44%, P < 0.001). Women had increased risk of postoperative complications compared to men (41.9% versus 11.3%, P = 0.003). There was no perioperative mortality in our series of elective EVAR cases. Median 5-y survival following EVAR was 64.4% for men and 76.3% for women (P = 0.599). Late SI rates following EVAR was 10.5% with 16 (10.7%) men and 3 (9.7%) women needing interventions (P = 0.870). Overall durability of EVAR extrapolated as time to SIs was 91% at 2 y and 85% at 5 y. Factors predisposing SIs were iliac tortuosity (P = 0.046), aortic neck angle (P = 0.022), and endoleak at the follow-up (P = 0.030). CONCLUSIONS: In this study, immediate outcomes following EVAR were different between men and women, with women having increased rates of postoperative complications. Mortality and overall long-term durability of EVAR, however, were the same between sexes despite anatomical differences. EVAR durability was significantly dependent on the severity of iliac tortuosity, aortic neck angulation, and presence of endoleak at the follow-up.

The role of adjuvant radiotherapy in pathologically lymph node-positive prostate cancer.

BACKGROUND: Postoperative management of prostate cancer with lymph node involvement (LNI) is controversial. Retrospective evidence supports the selective use of radiotherapy (RT) after extended pelvic lymph node dissection. It is unclear whether this is generalizable to practice in the United States, where extended dissection is uncommon. The authors identified patients with LNI who potentially could derive a survival benefit with adjuvant RT plus androgen-deprivation therapy (ADT). METHODS: Patients with N1M0 prostate adenocarcinoma who underwent radical prostatectomy (RP) and subsequently received ADT from 2003 through 2011 were identified from the National Cancer Database. Kaplan-Meier analyses, log-rank tests, and multivariable Cox proportional hazards regression were performed using overall survival (OS) as the primary outcome. RESULTS: In total, 906 of 2569 eligible patients (35.3%) received RT, and RT was more frequently received by patients who were diagnosed in later years, had fewer positive lymph nodes, had involved surgical margins, and were aged <65 years (all P < .05). The 5-year OS rate was 87% versus 82% in those who received RT versus those who did not (P = .007). After propensity score matching, 826 patients remained in each cohort. RT retained an association with OS (5-year OS: 88% vs 81%; P = .009; hazard ratio, 1.43; 95% confidence interval, 1.10-1.86; P = .008). No interaction was identified between the effect of RT on OS across tested strata of total lymph nodes examined, lymph node ratio, total number of positive lymph nodes, margin status, Gleason score, and prostate-specific antigen. CONCLUSIONS: RT plus ADT was associated with improved OS after RP in patients with LNI. These results may help guide therapy in the absence of randomized evidence. Cancer 2017;123:512-520. © 2016 American Cancer Society.

The human subthalamic nucleus and globus pallidus internus differentially encode reward during action control.

The subthalamic nucleus (STN) and globus pallidus internus (GPi) have recently been shown to encode reward, but few studies have been performed in humans. We investigated STN and GPi encoding of reward and loss (i.e., valence) in humans with Parkinson's disease. To test the hypothesis that STN and GPi neurons would change their firing rate in response to reward- and loss-related stimuli, we recorded the activity of individual neurons while participants performed a behavioral task. In the task, action choices were associated with potential rewarding, punitive, or neutral outcomes. We found that STN and GPi neurons encode valence-related information during action control, but the proportion of valence-responsive neurons was greater in the STN compared to the GPi. In the STN, reward-related stimuli mobilized a greater proportion of neurons than loss-related stimuli. We also found surprising limbic overlap with the sensorimotor regions in both the STN and GPi, and this overlap was greater than has been previously reported. These findings may help to explain alterations in limbic function that have been observed following deep brain stimulation therapy of the STN and GPi. Hum Brain Mapp 38:1952-1964, 2017. © 2017 Wiley Periodicals, Inc.

Impulsivity in Parkinson's disease is associated with altered subthalamic but not globus pallidus internus activity.

BACKGROUND: A significant subset of patients with Parkinson's disease (PD) suffer from impulse control disorders (ICDs). A hallmark feature of many ICDs is the pursuit of rewarding behaviours despite negative consequences. Recent evidence implicates the subthalamic nucleus (STN) and globus pallidus internus (GPi) in reward and punishment processing, and deep brain stimulation (DBS) of these structures has been associated with changes in ICD symptoms. METHODS: We tested the hypothesis that in patients with PD diagnosed with ICD, neurons in the STN and GPi would be more responsive to reward-related stimuli and less responsive to loss-related stimuli. We studied a cohort of 43 patients with PD (12 with an ICD and 31 without) undergoing DBS electrode placement surgery. Patients performed a behavioural task in which their action choices were motivated by the potential for either a monetary reward or a monetary loss. During task performance, the activity of individual neurons was recorded in either the STN (n=100) or the GPi (n=100). RESULTS: The presence of an ICD was associated with significantly greater proportions of reward responsive neurons (p<0.01) and significantly lower proportions of loss responsive neurons (p<0.05) in the STN, but not in the GPi. CONCLUSIONS: These findings provide further evidence of STN involvement in impulsive behaviour in the PD population.

Improved prostate delineation in prostate HDR brachytherapy with TRUS-CT deformable registration technology: A pilot study with MRI validation.

Accurate prostate delineation is essential to ensure proper target coverage and normal-tissue sparing in prostate HDR brachytherapy. We have developed a prostate HDR brachytherapy technology that integrates intraoperative TRUS-based prostate contour into HDR treatment planning through TRUS-CT deformable registration (TCDR) to improve prostate contour accuracy. In a perspective study of 16 patients, we investigated the clinical feasibility as well as the performance of this TCDR-based HDR approach. We compared the performance of the TCDR-based approach with the conventional CT-based HDR in terms of prostate contour accuracy using MRI as the gold standard. For all patients, the average Dice prostate volume overlap was 91.1 ± 2.3% between the TCDR-based and the MRI-defined prostate volumes. In a subset of eight patients, inter and intro-observer reliability study was conducted among three experienced physicians (two radiation oncologists and one radiologist) for the TCDR-based HDR approach. Overall, a 10 to 40% improvement in prostate volume accuracy can be achieved with the TCDR-based approach as compared with the conventional CT-based prostate volumes. The TCDR-based prostate volumes match closely to the MRI-defined prostate volumes for all 3 observers (mean volume difference: 0.5 ± 7.2%, 1.8 ± 7.2%, and 3.5 ± 5.1%); while CT-based contours overestimated prostate volumes by 10.9 ± 28.7%, 13.7 ± 20.1%, and 44.7 ± 32.1%. This study has shown that the TCDR-based HDR brachytherapy is clinically feasible and can significantly improve prostate contour accuracy over the conventional CT-based prostate contour. We also demonstrated the reliability of the TCDR-based prostate delineation. This TCDR-based HDR approach has the potential to enable accurate dose planning and delivery, and potentially enhance prostate HDR treatment outcome.

Recurrent prostate cancer detection with anti-3-[(18)F]FACBC PET/CT: comparison with CT.

PURPOSE: To compare the diagnostic performance of the synthetic amino acid analogue PET radiotracer anti-3-[(18)F]FACBC (fluciclovine) with that of CT in the detection of recurrent prostate carcinoma. METHODS: This was a retrospective analysis of 53 bone scan-negative patients with suspected recurrent prostate carcinoma who underwent fluciclovine PET/CT and routine clinical CT within 90 days of each other. The correlation between imaging findings and histology and clinical follow-up was evaluated. Positivity rates and diagnostic performance were calculated for fluciclovine PET/CT and CT. RESULTS: Of 53 fluciclovine PET/CT and 53 CT examinations, 41 (77.4 %) and 10 (18.9 %), respectively, had positive findings for recurrent disease. Positivity rates were higher with fluciclovine PET/CT than with CT at all prostate-specific antigen (PSA) levels, PSA doubling times and original Gleason scores. In the prostate/bed, fluciclovine PET/CT was true-positive in 31 and CT was true-positive in 4 of 51 patients who met the reference standard. In extraprostatic regions, fluciclovine PET/CT was true-positive in 12 and CT was true-positive in 3 of 41 patients who met the reference standard. Of the 43 index lesions used to prove positivity, 42 (97.7 %) had histological proof. In 51 patients with sufficient follow-up to calculate diagnostic performance in the prostate/bed, fluciclovine PET/CT demonstrated a sensitivity of 88.6 %, a specificity of 56.3 %, an accuracy of 78.4 %, a positive predictive value (PPV) of 81.6 %, and a negative predictive value (NPV) of 69.2 %; the respective values for CT were 11.4 %, 87.5 %, 35.3 %, 66.7 % and 31.1 %. In 41 patients with sufficient follow-up to calculate diagnostic performance in extraprostatic regions, fluciclovine PET/CT demonstrated a sensitivity of 46.2 %, a specificity of 100 %, an accuracy of 65.9 %, a PPV of 100 %, and an NPV of 51.7 %; the respective values for CT were 11.5 %, 100 %, 43.9 %, 100 % and 39.5 %. CONCLUSION: The diagnostic performance of fluciclovine PET/CT in recurrent prostate cancer is superior to that of CT and fluciclovine PET/CT provides better delineation of prostatic from extraprostatic recurrence.

Preventable Complications Driving Rising Costs in Management of Patients with Critical Limb Ischemia.

BACKGROUND: This study aimed to identify factors that drive increasing health-care costs associated with the management of critical limb ischemia in elective inpatients. METHODS: Patients with a primary diagnosis code of critical limb ischemia (CLI) were identified from the 2001-2011 Nationwide Inpatient Sample. Demographics, CLI management, comorbidities, complications (bleeding, surgical site infection [SSI]), length of stay, and median in-hospital costs were reviewed. Statistical analysis was completed using Students' t-test and Mann-Kendall trend analysis. Costs are reported in 2011 US dollars corrected using the consumer price index. RESULTS: From 2001 to 2011, there were a total of 451,823 patients who underwent open elective revascularization as inpatients for CLI. Costs to treat CLI increased by 63% ($12,560 in 2001 to $20,517 in 2011, P < 0.001 in trend analysis). Endovascular interventions were 20% more expensive compared with open surgery ($19,566 vs. $16,337, P < 0.001). Age, gender, and insurance status did not affect the cost of care. From 2001 to 2011, the number of patient comorbidities (7.56-12.40) and percentage of endovascular cases (13.4% to 27.4%) increased, accounting for a 6% annual increase in total cost despite decreased median length of stay (6 to 5 days). Patients who developed SSI had total costs 83% greater than patients without SSIs ($30,949 vs. $16,939; P < 0.001). Patients who developed bleeding complications had total costs 41% greater than nonbleeding patients ($23,779 vs. $16,821, P < 0.001). Overall, there was a 32% reduction in SSI rates but unchanged rates of bleeding complications during this period. CONCLUSIONS: The cost of CLI treatment is increasing and driven by rising endovascular use, SSI, and bleeding in the in-patient population. Further efforts to reduce complications in this patient population may contribute to a reduction in health care-associated costs of treating CLI.

The increasing incidence of thromboembolic events among hospitalized patients with inflammatory bowel disease.

BACKGROUND: We performed a national population-based study examining the incidence of both venous and arterial thromboembolic events in patients hospitalized with inflammatory bowel disease over the past decade. METHODS: A retrospective cross-sectional analysis using the Nationwide Inpatient Sample Database was performed. Patients hospitalized with Crohn's disease and ulcerative colitis were identified using ICD-9 codes. The incidence of clinically relevant venous thromboembolic events and arterial thromboembolic events including myocardial infarction, visceral ischemia, cerebrovascular accidents, and peripheral arterial events was examined. RESULTS: During the study period, 461,415 hospitalized inflammatory bowel disease patients were identified. Among these patients, 28,820 had a diagnosis of a thromboembolic event (overall prevalence of 6%). The incidence of thromboembolic events in patients with inflammatory bowel disease rose from 5.65% in 2000 to 7.17% by 2009. There were 18,270 (3.96%) patients who had an arterial thrombotic event, the most common being myocardial infarction (50%), followed by visceral ischemia (25%), and cerebrovascular incidents (22%). There were 11,083 (2.4%) patients identified to have had a venous thrombotic event, with the most common manifestation being deep vein thrombosis (77%), pulmonary embolism (32%), and portal vein thrombosis (3.9%). CONCLUSION: An increasing incidence of thromboembolic event in patients with inflammatory bowel disease was observed over the past decade. Interestingly, there were more arterial thrombotic events in comparison to venous thrombotic events.

The effect of Surgical Care Improvement Project measures on national trends on surgical site infections in open vascular procedures.

OBJECTIVE: The Surgical Care Improvement Project (SCIP) is a national initiative to reduce surgical complications, including postoperative surgical site infection (SSI), through protocol-driven antibiotic usage. This study aimed to determine the effect SCIP guidelines have had on in-hospital SSIs after open vascular procedures. METHODS: The Nationwide Inpatient Sample (NIS) was retrospectively analyzed using International Classification of Diseases, Ninth Revision, diagnosis codes to capture SSIs in hospital patients who underwent elective carotid endarterectomy, elective open repair of an abdominal aortic aneurysm (AAA), and peripheral bypass. The pre-SCIP era was defined as 2000 to 2005 and post-SCIP was defined as 2007 to 2010. The year 2006 was excluded because this was the transition year in which the SCIP guidelines were implemented. Analysis of variance and χ(2) testing were used for statistical analysis. RESULTS: The rate of SSI in the pre-SCIP era was 2.2% compared with 2.3% for carotid endarterectomy (P = .06). For peripheral bypass, both in the pre- and post-SCIP era, infection rates were 0.1% (P = .22). For open, elective AAA, the rate of infection in the post-SCIP era increased significantly to 1.4% from 1.0% in the pre-SCIP era (P < .001). Demographics and in-hospital mortality did not differ significantly between the groups. CONCLUSIONS: Implementation of SCIP guidelines has made no significant effect on the incidence of in-hospital SSIs in open vascular operations; rather, an increase in SSI rates in open AAA repairs was observed. Patient-centered, bundled approaches to care, rather than current SCIP practices, may further decrease SSI rates in vascular patients undergoing open procedures.

Endovascular management of a traumatic renal-caval arteriovenous fistula in a pediatric patient.

Traumatic renal arteriovenous fistula involving the inferior vena cava (IVC) are exceptionally rare, but if left untreated can have devastating clinical consequences, including development of renovascular hypertension, cardiomegaly, and congestive heart failure. We report a rare, pediatric case of a renal-caval arteriovenous fistula that developed after a gunshot wound to the abdomen and its subsequent treatment with endovascular means. We review our case and the world literature on the evaluation and management of trauma-related renal-caval arteriovenous fistulae.