To provide confirmatory evidence on the use of sulfasalazine to reduce enteritis during pelvic radiation therapy (RT), following 2 prior single-institution trials suggestive that benefit existed.
A ...multi-institution, randomized, double-blind, placebo-controlled phase 3 trial was designed to assess the efficacy of sulfasalazine versus placebo in the treatment of RT-related enteritis during RT including the posterior pelvis (45.0-53.5 Gy) and conducted through a multicenter national cooperative research alliance. Patients received 1000 mg of sulfasalazine or placebo orally twice daily during and for 4 weeks after RT. The primary endpoint was maximum severity of diarrhea (Common Terminology Criteria for Adverse Events version 4.0). Toxicity and bowel function were assessed by providers through a self-administered bowel function questionnaire taken weekly during RT and for 6 weeks afterward.
Eighty-seven patients were enrolled in the trial between April 29, 2011, and May 13, 2013, with evenly distributed baseline factors. At the time of a planned interim toxicity analysis, more patients with grade ≥3 diarrhea received sulfasalazine than received placebo (29% vs 11%, P=.04). A futility analysis showed that trial continuation would be unlikely to yield a positive result, and a research board recommended halting study treatment. Final analysis of the primary endpoint showed no significant difference in maximum diarrhea severity between the sulfasalazine and placebo arms (P=.41).
Sulfasalazine does not reduce enteritis during pelvic RT and may be associated with a higher risk of adverse events than placebo. This trial illustrates the importance of confirmatory phase 3 trials in the evaluation of symptom-control agents.
Objective Percutaneous access during endovascular aortic repair has been shown to be feasible and safe using a suture-mediated closure device (“Preclose” technique) for closure of up to 24F ...introducer sheaths. The purpose of this study is to examine the late outcomes of those femoral arteries repaired in this manner. Methods The Preclose technique has been previously described. Briefly, the technique involves two Perclose Proglide devices deployed in the femoral artery prior to insertion of the large diameter introducer sheath and then closure of the arteriotomy by tying down knots of the Proglide following removal of the sheath. The medical records of all patients who underwent endovascular aortic repairs using the Preclose technique between December 2004 and August 2007 were reviewed. Follow-up protocol consisted of computed tomography (CT) angiograms performed at 1, 6, and 12 months, and annually thereafter. All Preclose patients who had at least a 6-month postoperative scan were included in the study. For each patient, the most recent postoperative scan was compared with the preoperative scan for evidence of any new anatomic abnormalities of the femoral artery such as dissection, stenosis, or pseudoaneurysm. Three-dimensional post processing with multiplanar reconstructions was also performed as necessary to confirm axial scan findings. Results A total of 292 patients underwent percutaneous endovascular aortic repairs (TEVAR-125, EVAR-167). Four hundred thirty-two femoral arteries were closed with 870 devices. Four hundred eighteen vessels were approximated with two devices, while 30 arteries required three devices for hemostasis and an additional four vessels only required a single device. Two hundred seventy-eight (64.3%) vessels were accessed with sheaths 18 to 24F. Four hundred eight femoral arteries (94.4%) were closed successfully with the Preclose technique. There were 100 patients (TEVAR-35, EVAR-65) who had adequate postoperative CT scan at 6-months or later. The mean follow up was 11.6 ± 5.0 months. Of the 156 femoral arteries in these 100 patients repaired using the Preclose technique, there were 3 late complications in 3 patients, 1 asymptomatic femoral artery dissection, and 2 femoral artery pseudoaneurysms requiring surgical repair, resulting in a late complication rate of 1.92% (3/156). Conclusion Percutaneous closure of femoral arteries after large diameter introducer sheaths using the Preclose technique has a low incidence of early and late complications related to the closure site.
Appropriate imaging modalities for screening, staging, and surveillance of patients with suspected and documented metastatic disease to bone include (99m)Tc bone scanning, MRI, CT, radiography, and ...2-(18)Ffluoro-2-deoxyglucose-PET. Clinical scenarios reviewed include asymptomatic stage 1 breast carcinoma, symptomatic stage 2 breast carcinoma, abnormal bone scan results with breast carcinoma, pathologic fracture with known metastatic breast carcinoma, asymptomatic well-differentiated and poorly differentiated prostate carcinoma, vertebral fracture with history of malignancy, non-small-cell lung carcinoma staging, symptomatic multiple myeloma, osteosarcoma staging and surveillance, and suspected bone metastasis in a pregnant patient. No single imaging modality is consistently best for the assessment of metastatic bone disease across all tumor types and clinical situations. In some cases, no imaging is indicated. The recommendations contained herein are the result of evidence-based consensus by the ACR Appropriateness Criteria((R)) Expert Panel on Musculoskeletal Radiology.
Background Advances in centrifugal blood pump technology have led to increased use of centrifugal pumps in extracorporeal membrane oxygenation (ECMO) circuits. Their efficacy and safety in critically ...ill neonates remains unknown. Blood cell trauma leading to hemolysis may result in end-organ injury in critically ill neonates receiving centrifugal pump ECMO. We hypothesized that neonates undergoing ECMO support using centrifugal pumps were at increased odds of hemolysis and subsequent end-organ injury. Methods Children 30 days of age or younger who received support with venoarterial ECMO and were reported to the Extracorporeal Life Support Registry during 2007 to 2009 underwent propensity score matching (Greedy matching 1:1) using pre-ECMO support characteristics. Results A total of 1,592 neonates receiving ECMO (centrifugal pump = 163 and roller pump = 1,492) were identified. Significant differences in demographic, presupport, and cannulation variables were present before matching. One hundred seventy-six neonates who were supported using either centrifugal (n = 88) or roller pumps (n = 88) were matched using propensity scoring. No significant differences in demographic, presupport, or cannulation variables were present after matching. Neonates undergoing support using centrifugal pumps had increased odds of hemolysis (odds ratio OR, 7.7 2.8–21.2), hyperbilirubinemia (OR, 20.8 2.7–160.4), hypertension (OR, 3.2 1.3–8.0), and acute renal failure (OR, 2.4 1.1–5.6). Survival to discharge was not different between pump types. Conclusions Use of ECMO using centrifugal pumps is associated with increased odds of hemolysis that likely contributes to other end-organ injury. Research into the optimal use of centrifugal pumps and strategies to prevent support-related complications need to be investigated.
Background The distal revascularization and interval ligation (DRIL) procedure has evolved as the optimal treatment for access-related hand ischemia despite concerns about its durability. This study ...was designed to review our institutional experience and objectively define its mid-term outcome. Methods A retrospective review of all patients undergoing the DRIL procedure was performed. The diagnosis of severe hand ischemia was made based primarily upon clinical presentation, but confirmed with noninvasive imaging in select cases. The DRIL conduit was selected based upon noninvasive imaging (vein conduit criteria: saphenous > arm; diameter ≥3 mm) and the proximal anastomosis was positioned ≥7 cm from the access anastomosis. The DRIL bypasses were followed in a graft surveillance protocol and remedial procedures performed as dictated by clinical or ultrasound scan findings. Results Sixty-four DRIL procedures were performed in 61 patients (age - 58 ± 13 standard deviation SD, female – 62%, diabetic – 72%). The index access procedures included: autogenous brachiocephalic – 46%, autogenous brachiobasilic – 31%, autogenous brachioaxillary translocated femoral vein – 20%, other –3%. The precipitating symptoms were pain (25%), paresthesia (34%), motor dysfunction (24%), and tissue loss (17%); a pre-emptive DRIL was performed in 5 patients. The timing of the DRIL relative to the index access was dictated by the symptoms: <24 hrs – 19%; 1 day ≤ DRIL ≤7 days – 29%; 7 days ≤ DRIL ≤30 days – 8%; >30 days – 44%. Perioperative mortality rate was 3% and the complication rate was 22% (wound – 14%). The DRIL procedure relieved the ischemic symptoms in 78% of the cases (residual symptoms: paresthesia – 13%; pain – 5%; tissue loss – 4%; motor – 2%). The DRIL also resulted in significant ( P < .05) increases in both the wrist/brachial index (WBI) and digital/brachial index (DBI) with the mean increases of 0.34 ± 0.26 and 0.41 ± 0.21, respectively. The primary DRIL patency rates (± standard error of the mean SEM) were 77 ± 8%, 74 ± 9%, and 71 ± 9% at 1 year, 3 years, and 5 years, respectively, while the corresponding secondary patency rates were 81 ± 7%, 76 ± 9%, and 76 ± 9%, and the survival rates were 71 ± 6%, 59 ± 7%, and 33 ± 9%. The index access procedure went on to mature sufficiently for cannulation in 68% of the cases when the DRIL was performed early (ie, <3 months from index access); all accesses functional at the time of the DRIL were used for dialysis throughout the perioperative period. Conclusion The DRIL procedure safely and effectively relieves the symptoms of severe access-related hand ischemia while preserving the access. The midterm results suggest that the DRIL bypasses are durable, although long-term graft surveillance may be justified given the observed failures.
Background With the US Food and Drug Administration approval of the TAG thoracic device, more thoracic pathologies are being treated using endovascular techniques. Although endovascular abdominal and ...thoracic aortic repairs have some apparent similarities, there are substantive anatomic, pathologic, and technical differences that could impact perioperative outcomes. The purpose of this study is to identify these differences. Methods During a 5-year period, 121 endovascular thoracic aortic repairs (TEVAR) and 450 abdominal aortic repairs (EVAR) were performed at a single institution. Preoperative, intraoperative, and early postoperative data were prospectively collected and retrospectively reviewed. Aggregate outcome measures were compared between the two cohorts, with statistical significance achieved at P < .05. Results The mean age of patients undergoing EVAR was 72.8 ± 8.3 compared with 68.3 ± 13.9 for TEVAR ( P = .02). More women underwent TEVAR (30.6% vs 11.1%, P < .001). Aneurysms undergoing TEVAR were larger than those for EVAR (62.0 mm vs 58.3 mm, P = .01). Intraoperatively, EVAR required 26.2 minutes of fluoroscopy compared with 22.1 minutes for TEVAR ( P < .001). The amount of contrast used was higher in TEVAR (133.6 mL vs 93.6 mL, P < .001). The mean procedure times were 164 minutes for EVAR and 115 minutes for TEVAR ( P < .001). Iliac conduits were required in 46 patients (10.2%) undergoing EVAR, and in 24 (19.8%) undergoing TEVAR ( P = .007). The 30-day or in-hospital mortality was 2.0% for EVAR and 5.0% for TEVAR ( P = NS). The median length of stay was longer for TEVAR (3 days vs 2 days, P = .034). There were 54 postoperative complications in 36 TEVAR patients (29.8%), including 13 neurologic (10.7%), 8 renal (6.6%), 7 pulmonary (5.8%), 6 ischemic (5.0), and 5 (4.1%) hemorrhagic events. Among the EVAR group, 136 (30.2%) patients had postoperative complications, which included 45 ischemic (10.0%), 34 wound (7.6%), 22 renal (4.9%), 12 cardiac (2.7%), 8 pulmonary (1.8%), 5 gastrointestinal (1.1%), and 4 neurologic (0.9%) events. Conclusions A relatively higher proportion of women underwent TEVAR than EVAR, and this was reflected in the greater need for iliac conduits to accommodate the larger delivery catheters of the thoracic devices. Intraoperative imaging techniques were also different, and TEVAR required higher contrast volumes despite shorter overall procedure times. The incidence of strokes and spinal cord ischemia was also higher during TEVAR. Despite apparent similarities of devices and techniques, EVAR and TEVAR are fundamentally different procedures with different perioperative outcomes.
Imaging of the diabetic foot is among the most challenging areas of radiology. The authors present a consensus of the suggested tests in several clinical scenarios, such as early neuropathy, ...soft-tissue swelling, skin ulcer, and suspected osteomyelitis. In most of these situations, magnetic resonance imaging (MRI) with or without contrast is the examination of choice. Most other imaging tests have complementary roles. For soft-tissue swelling or an ulcer, radiography and MRI with or without contrast are suggested. Bone scintigraphy with white blood cell scanning is used when MRI is contraindicated. In patients with diabetes without ulcers, radiography and MRI with or without contrast are suggested; bone scanning may be used when MRI is contraindicated.
The shoulder joint is a complex array of muscles, tendons, and capsuloligamentous structures that has the greatest freedom of motion of any joint in the body. Acute (<2 weeks) shoulder pain can be ...attributable to structures related to the glenohumeral articulation and joint capsule, rotator cuff, acromioclavicular joint, and scapula. The foundation for investigation of acute shoulder pain is radiography. Magnetic resonance imaging is the procedure of choice for the evaluation of occult fractures and the shoulder soft tissues. Ultrasound, with appropriate local expertise, is an excellent evaluation of the rotator cuff, long head of the biceps tendon, and interventional procedures. Fluoroscopy is an excellent modality to guide interventional procedures. Computed tomography is an excellent modality for characterizing complex shoulder fractures. Computed tomographic arthrography or fluoroscopic arthrography may be alternatives in patients for whom MR arthrography is contraindicated. A multimodal approach may be required to accurately assess shoulder pathology. The ACR Appropriateness Criteria(®) are evidence-based guidelines for specific clinical conditions that are reviewed every 2 years by a multidisciplinary expert panel. The guideline development and review include an extensive analysis of current medical literature from peer-reviewed journals and the application of a well-established consensus methodology (modified Delphi) to rate the appropriateness of imaging and treatment procedures by the panel. In those instances in which evidence is lacking or not definitive, expert opinion may be used to recommend imaging or treatment.
Background The morbidity and mortality rates associated with open thoracoabdominal aortic aneurysm (TAAA) repair are substantial. This study was designed to review our early experience with the ...hybrid endovascular and, or open approach for TAAA repair. Study Design Patients undergoing elective hybrid repair of their TAAAs were retrospectively reviewed. Results Seventeen patients (mean age 69 ± 15 years, male, 76%) underwent visceral and renal revascularization as the first stage of their hybrid repair. The Crawford extent included: II, 2; III, 8; and IV, 7. Perioperative mortality and complication rates after the first stage were 24% and 25%, respectively; the mean intensive care unit stay and total length of stay were 7 ± 12 days (range 1 to 45 days) and 22 ± 33 days (range 3 to 100 days), respectively. The endovascular aneurysm repair or second stage procedure was performed in 12 of 13 (92%) of the surviving patients, with a mean of 27 ± 27 days (range 6 to 99 days) between the procedures. Two patients experienced intraoperative complications during the second stage, but there were no deaths or additional postoperative complications. Patients did not require the intensive care unit, and the overall mean length of stay after the second stage was 2 ± 2 days (range 1 to 5 days). The mean postoperative followup among the 11 patients completing both stages was 8 ± 12 months (range 1 to 15 months). The primary patency rate for the visceral and renal bypasses was 96% (54 of 56). Conclusions The hybrid approach for patients with TAAAs may reduce complications in the average, low-risk patient and may extend the indications for repair to patients considered higher risk based on age, comorbidities, or anatomic considerations.
Objective Device cost is a substantial component of the overall cost of endovascular abdominal aneurysm repair (EVAR), and the four commercially available devices differ significantly in the cost of ...their basic configuration. This study examined the impact of three different endografts and their product lines on the overall cost of repair. Methods Implant records of 467 EVAR procedures performed during 2000 through 2006 were reviewed. The three devices used were the AneuRx in 178 (38.1%; Medtronic, Santa Rosa, Ca), the Excluder in 123 (26.3%; W. L. Gore & Associates, Flagstaff, Ariz), and the Zenith in 166 (35.5%; the Cook Zenith (Bloomington, Ind). The Powerlink device (Endologix, Irvine, Calif) was not studied. The specific device implanted was determined by its commercial availability at the time of repair, patient anatomy, and surgeon preference. Retail list prices were used for all calculations, and only devices used during the original repair were used for analysis. Results The device cost of the most basic configuration for repair (ie, 2 pieces for AneuRx and Excluder, 3 pieces for Zenith) differed by $3022 between the most expensive (Zenith) to the least expensive (AneuRx). However, the AneuRx system required the most number of extensions (1.90 ± 1.25 per case; range, 0-7), whereas the Zenith required the fewest (0.21 ± 0.51 per case; range, 0-3). When the costs of the extensions were added, the overall mean device costs per case were similar. Conclusion The initial cost advantage of the AneuRx and Excluder endograft systems were offset by the more frequent need for proximal and distal extensions. The minimum device cost of a basic repair should not factor into the decision to select one specific device over another because additional devices may be required depending on the design and construction of the endograft system and the accuracy and reliability of their deployment mechanisms.
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