An Unsuccessful Randomized Trial of Percutaneous vs Endoscopic Drainage of Suspected Malignant Hilar Obstruction.

Percutaneous transhepatic biliary drainage (PTBD) and endoscopic retrograde cholangiopancreatography (ERCP) are widely accepted but competing approaches for the management of malignant obstruction at the hilum of the liver. ERCP is favored in the United States on the basis of high success rates for non-hilar indications, the perceived safety and superior tissue sampling capability of ERCP relative to PTBD, and the avoidance of external drains that are undesirable to patients. A recent randomized controlled trial (RCT) comparing the 2 modalities in patients with resectable hilar cholangiocarcinoma was terminated prematurely because of higher mortality in the PTBD group.1 In contrast, most observational data suggest that PTBD is superior for achieving complete drainage.2-6 Because the preferred procedure remains uncertain, we aimed to compare PTBD and ERCP as the primary intervention in patients with cholestasis due to malignant hilar obstruction (MHO).

Multicenter Trial of the VenaTech Convertible Vena Cava Filter.

PURPOSE: To demonstrate rates of successful filter conversion and 6-month major device-related adverse events in subjects with converted caval filters. MATERIALS AND METHODS: An investigational device exemption multicenter, prospective, single-arm study was performed at 11 sites enrolling 149 patients. The VenaTech Convertible Vena Cava Filter (B. Braun Interventional Systems, Inc, Bethlehem, Pennsylvania) was implanted in 149 patients with venous thromboembolism and contraindication to or failure of anticoagulation (n = 119), with high-risk trauma (n = 14), and for surgical prophylaxis (n = 16). When the patient was no longer at risk for pulmonary embolism as determined by clinical assessment, an attempt at filter conversion was made. Follow-up of converted patients (n = 93) was conducted at 30 days, 3 months, and 6 months after conversion. Patients who did not undergo a conversion attempt (n = 53) had follow-up at 6 months after implant. RESULTS: All implants were successful. One 7-day migration to the right atrium required surgical removal. Technical success rate for filter conversion was 92.7% (89/96). Mean time from placement to conversion was 130.7 days (range, 15-391 d). No major conversion-related events were reported. The mean conversion procedure time was 30.7 minutes (range, 7-135 min). There were 89 converted and 32 unconverted patients who completed 6-month follow-up with no delayed complications. CONCLUSIONS: The VenaTech Convertible filter has a high conversion rate and low 6-month device-related adverse event rate. Further studies are necessary to determine long-term safety and efficacy in both converted and unconverted patients.

Aviation and Procedural Medicine.

Aviation and medicine are two complex fields involving many interdependent steps where problems can occur. When they inevitably do the outcome can be catastrophic, leading to injury or even loss of life. While both professions have made great strides to reduce error and improve safety, we would suggest medicine can still learn much from the approach aviation has developed. We will show how pilots spend a significant amount of time on planning and early recognition of impending challenges, utilize the concept of crew resource management routinely, and stay much focused during each specific mission. More importantly, they are very open and committed to discussing every event or near event to improve the system, and are supported in this by their superiors without fear of punishment or retribution. By adopting many of these principles, medicine can develop a true culture of safety such as aviation has done, leading to a remarkable improvement in their safety record.

Prostate cancer: MR imaging-guided galvanotherapy--technical development and first clinical results.

PURPOSE: To prospectively evaluate the safety and effectiveness of magnetic resonance (MR) imaging-guided galvanotherapy in prostate cancer. MATERIALS AND METHODS: This prospective study was approved and authorized by the institutional review board, and patients gave informed consent. Forty-four men (mean age, 63.1 years) with histologically proved prostate cancer were treated with galvanotherapy. After transgluteal puncture of the prostate with local anesthesia, two MR imaging-compatible electrodes were positioned under MR imaging guidance in the periphery of the right and left lobes of the prostate so that they had direct tumor contact. The patients were treated three times in 1-week intervals, and direct current was applied to the localized cancer in the prostate gland with a total charge of 350 coulombs. Follow-up with laboratory testing (prostate-specific antigen [PSA] levels) and endorectal MR imaging with tumor volume measurement was performed 3, 6, and 12 months after the procedure. The Friedman test was used to compare tumor volumes and PSA levels across the four time points. RESULTS: All patients tolerated MR imaging-guided galvanotherapy well without any major side effects or complications. Six patients had some reversible difficulty with urination, and five reported temporary unilateral leg paresthesia. Tumor volume as determined with MR imaging decreased from a pretherapeutic median of 1.90 to 1.12 cm(3), which corresponded to a significant (P < .01) reduction of 41%. One patient (2%) had complete remission and 18 (41%) had partial remission at follow-up 12 months after therapy. Twenty-three patients (52%) were classified as having stable disease. Two patients (5%) had progressive disease. Median PSA levels decreased in the 12-month control period from 7.05 to 2.4 ng/mL (66%, P < .01). CONCLUSION: MR imaging-guided galvanotherapy is a safe procedure and can result in local control of prostatic carcinoma, with a concomitant reduction in the PSA level. SUPPLEMENTAL MATERIAL: http://radiology.rsnajnls.org/cgi/content/full/245/2/895/DC1.

Palliative hepatic intraarterial chemotherapy (HIC) using a novel combination of gemcitabine and mitomycin C: results in hepatic metastases.

To evaluate repeated hepatic intraarterial chemotherapy (HIC) as a palliative treatment option for unresectable cholangiocarcinoma and liver metastases of various origins that were progressive under systemic chemotherapy. Between 2002 and 2006, 55 patients were treated in 4-week intervals (mean five sessions). Combined gemcitabine/mitomycin was administered intraarterially within 1 h. Tumor response was evaluated after the third session according to RECIST. Treated tumor entities were colorectal carcinoma (CRC) (n = 12), breast cancer (BC) (n = 12), cholangiocarcinoma (CCC) (n = 10), pancreatic (n = 4), ovarian (n = 3), gastric, cervical, papillary (each n = 2), prostate, esophageal carcinoma, leiomyosarcoma (each n = 1), cancer of unknown primacy (CUP) (n = 5). All patients tolerated the treatment well without any major side effects or complications. In total, there were 1 complete response (CR), 19 partial responses (PR), 19 stable (SD) and 16 progressive diseases (PD). We observed 5 PR, 3 SD and 4 PD in CRC; 1 CR, 4 PR, 6 SD in BC; and 2 PR, 2 SD and 6 PD in CCC. Median survival after first HIC was 9.7 months for CRC, 11.4 months for BC and 6.0 months for CCC. HIC with gemcitabine/mitomycin is a safe, minimally invasive, palliative treatment for hepatic metastases that are progressive under systemic chemotherapy. The treatment yields respectable tumor control rates in CRC and BC patients.

Comparative results of Doppler sonography after TIPS using covered and bare stents.

OBJECTIVE: Our purpose was to evaluate the role of sonography in the early follow-up of patients with a covered transjugular intrahepatic portosystemic shunt (TIPS). CONCLUSION: Routine baseline Doppler sonography should occur 7-14 days after shunt placement unless malfunction or procedural complications are suspected.

Anatomic relationship of the internal jugular vein and the common carotid artery applied to percutaneous transjugular procedures.

PURPOSE: To demonstrate the anatomic relationship of the internal jugular vein (IJV) with the common carotid artery (CCA) in order to avoid inadvertent puncture of the CCA during percutaneous central venous access or transjugular interventional procedures. METHODS: One hundred and eighty-eight consecutive patients requiring either central venous access or interventional procedures via the IJV were included in the analysis. The position of the IJV in relation to the CCA was demonstrated by portable ultrasonography. The IJV location was recorded in a clock-dial system using the carotid as the center of the dial and the angles were measured. Outcomes of the procedure were also recorded. RESULTS: The IJV was lateral to the CCA in 187 of 188 patients and medial to the CCA in one patient. The left IJV was at the 12 o'clock position in 12 patients (6%), the 11 o'clock position in 17 patients (9%), the 10 o'clock position in 142 patients (75%) and at the 9 o'clock position in 17 patients (9%). The right IJV was at the 12 o'clock position in 8 patients (4%), the 1 o'clock position in 31 patients (16%), the 2 o'clock position in 134 patients (71%) and the 3 o'clock position in 17 patients (9%). In one patient the left IJV was located approximately 60 degrees medial to the left CCA; this was recorded as 2 o'clock on the left since it is opposite to the 10 o'clock position. CONCLUSION: Knowledge of the IJV anatomy and relationship to the CCA is important information for the operator performing an IJV puncture, to potentially reduce the chance of laceration of the CCA and avoid placement of a large catheter within a critical artery, even when ultrasound guidance is used.

Isolated right segmental hepatic duct injury following laparoscopic cholecystectomy.

PURPOSE: Laparoscopic cholecystectomy (LC) is the treatment of choice for gallstones. There is an increased incidence of bile duct injuries in LC compared with the open technique. Isolated right segmental hepatic duct injury (IRSHDI) represents a challenge not only for management but also for diagnosis. We present our experience in the management of IRSHDI, with long-term follow-up after treatment by a multidisciplinary approach. METHODS: Twelve consecutive patients (9 women, mean age 48 years) were identified as having IRSHDI. Patients' demographics, clinical presentation, management and outcome were collected for analysis. The mean follow-up was 44 months (range 2-90 months). RESULTS: Three patients had the LC immediately converted to open surgery without repair of the biliary injury before referral. Treatments before referral included endoscopic retrograde cholangiopancreatography (ERCP), percutaneous drainage and surgery, isolated or in combination. The median interval from LC to referral was 32 days. Eleven patients presented with biliary leak and biloma, one with obstruction of an isolated right hepatic segment. Post-referral management of the biliary lesion used a combination of ERCP stenting, percutaneous drainage and stent placement and surgery. In 6 of 12 patients ERCP was the first procedure, and in only one case was IRSHDI identified. In 6 patients, percutaneous transhepatic cholangiography (PTC) was performed first and an isolated right hepatic segment was demonstrated in all. The final treatment modality was endoscopic management and/or percutaneous drainage and stenting in 6 patients, and surgery in 6. The mean follow-up was 44 months. No mortality or significant morbidity was observed. CONCLUSION: Successful management of IRSHDI after LC requires adequate identification of the lesion, and multidisciplinary treatment is necessary. Half of the patients can be treated successfully by nonsurgical procedures.

Stent migration complicating treatment of inferior vena cava stenosis after orthotopic liver transplantation.

A case of inferior vena cava (IVC) stenosis after orthotopic liver transplantation was treated with balloon angioplasty and Wallstent placement. There was stent migration into the right atrium (RA), and percutaneous removal of the stent was attempted without success. Open cardiac surgery was required for stent removal and repair of aortic/RA fistula. Months later, recurrent IVC stenosis was successfully treated with placement of large Z stents after additional failed surgical repair. At 2 years follow-up, the patient is asymptomatic and Doppler ultrasonography demonstrated the stent to be patent and well-positioned.

Thrombosed dialysis access grafts: randomized comparison of the Amplatz thrombectomy device and surgical thromboembolectomy.

We report the final results of the trial comparing the Amplatz thrombectomy device (ATD) with surgical thromboembolectomy (ST) to declot thrombosed dialysis access grafts (DAG). The study population consisted of 174 DAG, 109 of which were randomized to mechanical thrombectomy using the ATD and 65 of which were randomized to conventional surgical thromboembolectomy. Forty grafts were re-enrolled in the trial when they failed beyond the 90 days follow-up after the initial treatment. Thirty-one were re-enrolled for mechanical thrombectomy and nine were re-enrolled for surgical thrombectomy, resulting in a total of 140 ATD procedures and 74 surgical thromboembolectomy. Immediate thrombectomy success was defined as greater than 90% thrombus removal followed by the ability to dialyze after treatment, and analysis of long term success based on graft patency at 30 and 90 days, with successful dialysis. Immediate thrombectomy success with the ATD procedure was achieved in 79.2% and with ST in 73.4%. Patency of the graft, with successful dialysis, at 30 days with the ATD procedure was 79.2% and with ST was 73.4%. Patency of the graft, with successful dialysis, at 90 days with the ATD procedure was 75.2% and with ST was 67.8%. The data collected in this study provided a prospective comparison of mechanical thrombectomy with the ATD and ST performance in thrombosed DAG. The results of the performance of both methods were comparable. No statistically significant differences were seen.

Transcatheter splenic artery occlusion for treatment of splenic artery steal syndrome after orthotopic liver transplantation.

PURPOSE: To review some aspects of the problem of splenic artery steal syndrome as cause of ischemia in transplanted livers and treatment by selective splenic artery occlusion. MATERIALS AND METHODS: Eleven liver transplant patients from a group of 350 patients, nine men and two women, ranging in age from 40 years to 61 years (mean 52 years), presented with biochemical evidences of liver ischemia and failure, ranging from one to 60 days following orthotopic liver transplantation. Diagnosis of splenic artery steal syndrome was suspected by elevated enzymes, Doppler ultrasound and confirmed by celiac angiogram. Patients with confirmed hepatic artery thrombosis before angiography were excluded from the study. Embolization with Gianturco coils was performed. RESULTS: All patients were treated by splenic artery embolization with Gianturco coils. The 11 patients improved clinically within 24 hours of the procedure with significant change in the biochemical and clinical parameters. Followup ranged from one month to two years. One of the 11 patient initially improved, but developed hepatic artery thrombosis within 24 hours of the embolic treatment, requiring surgical repair. CONCLUSION: Splenic artery steal syndrome following liver transplantation surgery can be diagnosed by celiac angiography, and effectively treated by splenic artery embolization with coils. Embolization is one of the treatments available, it is minimally invasive, and leads to immediate clinical improvement. Hepatic artery thrombosis is a possible complication of the procedure.