Human Amniotic Epithelial Cell Transplantation is Safe and Well Tolerated in Patients with Compensated Cirrhosis: A First-in-Human Trial.

Placenta-derived human amniotic epithelial cells (hAEC) exhibit anti-inflammatory and anti-fibrotic effects in cirrhosis models. We conducted a first-in-human phase I clinical trial to assess the safety and tolerability of hAEC in adults with compensated cirrhosis. We examined increasing and repeated doses of hAEC in 9 patients in 3 cohorts. Cohort 1 patients received 0.5 × 106/kg hAEC in one IV infusion. Cohort 2 patients received 1 × 106/kg hAEC in one IV infusion. The patients in cohort 3 received 1 × 106/kg hAEC on days 0 and 28. Here, we report follow-up to post-infusion day 56 (D56), during which no serious adverse events occurred. Six patients experienced no study-related adverse events, while 3 patients reported mild (grade 1) headaches that were possibly infusion-related. A transient decrease in serum platelet count occurred in all patients, which returned to baseline screening values by day 5. FIB-4 values to assess fibrosis were significantly lower at D56. Although not statistically significant, serum AST levels and liver stiffness measurements at D56 were lower than those at baseline. The hepatic venous pressure gradient, a measure of portal hypertension, declined in 4 patients, did not change in 3 patients, and increased in 2 patients. In conclusion, intravenous infusion of allogeneic hAEC in patients with compensated cirrhosis at the doses used in this study was safe and well tolerated, with no difference observed between 1 and 2 doses. Decreased hepatic inflammation, liver stiffness, and portal hypertension support larger studies aimed at identifying patients who may benefit from this therapy. Clinical Trial registration: The trial was prospectively entered on the Australian Clinical Trials Registry (ANZCTR12616000437460).

Refractory portal hypertension complications successfully managed by parallel transjugular intrahepatic portosystemic shunt (TIPS): a case report.

BACKGROUND: Transjugular intrahepatic portosystemic shunt (TIPS) is an established intervention to treat complicated portal hypertension refractory to medical or endoscopic management. TIPS dysfunction results in the recurrence of portal hypertension symptoms. In cases of TIPS dysfunction or persistent portal hypertension despite a patent primary TIPS, the creation of parallel TIPS may be the only intervention to effectively reduce portal pressure. Since the introduction of dedicated TIPS stents (Viatorr®) the incidence of TIPS dysfunction has reduced profoundly. Nevertheless, the creation of a parallel TIPS can still be necessary in the current dedicated TIPS stent era. CASE PRESENTATION: We report one such patient who experienced ongoing portal hypertension induced upper gastro-intestinal haemorrhage despite multiple TIPS revisions and a patent primary TIPS. CONCLUSION: Following creation of a parallel TIPS, the patient remains in clinical remission with no further bleeding.

A randomized, double-blind, placebo-controlled study of preemptive oral oxycodone with morphine patient-controlled anesthesia for postoperative pain management in patients undergoing uterine artery embolization for symptomatic uterine fibroids.

PURPOSE: To evaluate the analgesic efficacy of oral premedication of oxycodone in a group of patients undergoing elective uterine artery embolization under sedation for fibroid disease. METHODS: Thirty-nine patients (mean age 42.3 years) were prospectively randomized 1:1 to receive 20 mg oxycodone or placebo orally immediately before their procedure. At the commencement of the procedure, patients were provided with a patient-controlled analgesia device for 24 h, programmed to deliver 1 mg boluses of intravenous morphine with a 5 min lockout. Mean visual analog scale pain intensity ratings (0-100 mm) were measured from both groups and evaluated over 0 to 6 h as the primary end point. Other measured parameters included opioid-related side effects and eligibility for discharge (NCT00163930; September 12, 2005). RESULTS: Early pain intensity did not vary significantly between the active and placebo groups [mean (standard deviation): 3.2 (2.5) vs. 3.1 (2.2), p = 0.89]. The oxycodone group, however, experienced significantly more nausea (p = 0.035) and a greater incidence of vomiting (p = 0.044). Overall opioid requirement over 24 h, measured as oral morphine equivalent, was greater in the oxycodone group (median [interquartile range]: 64.5 [45-90] mg vs. 22.5 [15-46.5] mg, p < 0.0001). The number of patients first eligible for discharge at 24 h in the oxycodone group was decreased but not significantly (p = 0.07). CONCLUSION: The addition of preprocedural oral oxycodone to morphine patient-controlled analgesia does not offer any analgesic advantage to patients having uterine artery embolization and may cause a greater incidence of nausea and vomiting.

Endovascular closure of ascending aortic pseudoaneurysm with a type II Amplatzer vascular plug.

A 71-year-old man initially presented with an asymptomatic, incidentally detected ascending aortic pseudoaneurysm 25 years following aortic root repair with mechanical aortic valve replacement. This pseudoaneurysm was previously treated with coil embolization but due to coil impaction it reopened 8 years later. Endovascular closure of the pseudoaneurysm was achieved with the off-label use of a type II Amplatzer vascular plug.

Pulmonary embolism and the use of vena cava filters after major trauma.

BACKGROUND: Major trauma patients are at significant risk of developing pulmonary embolism (PE). We aimed to (i) analyse the current incidence and timing of PE after injury; (ii) identify risk factors that predispose major trauma patients to the occurrence of PE; and (iii) describe the use of vena cava filters (VCFs) following major trauma. METHODS: Prospectively collected data from The Alfred Hospital's Trauma Registry were used to identify all major trauma patients admitted over a 7-year period. A multivariable logistic regression model was used to identify factors associated with the occurrence of PE. A similar model was developed to identify factors associated with the use of VCFs inserted at the discretion of the treating clinician. RESULTS: A total of 6344 major trauma patients were treated during this period, with 73.2% male, mean age of 44.2, 90.2% with a blunt mechanism of injury and mean injury severity score of 24.3. Prophylactic VCFs were inserted in 511 patients (8.1%), with a mean time to insertion of 3.6 days after injury. There were 45 PE, 2 of which were fatal. The mean time to PE was 12 days post-injury. Three variables were independently associated with the occurrence of PE: the absence of a VCF; number of injuries to the lower limb; and central venous catheterization. CONCLUSION: The PE rate was 0.71%. Lower limb injuries and central venous catheterization are independently associated with a higher risk of PE after major trauma and VCFs are associated with a reduced risk.

Deep vein thrombosis and pulmonary embolus in patients with traumatic brain injury: a prospective observational study.

BACKGROUND: Intensive care patients with traumatic brain injury (TBI) are at high risk of developing deep vein thrombosis (DVT). A high rate of DVT was reported before routine thromboprophylaxis, but the current DVT rate in TBI patients receiving best-practice mechanical and pharmacological prophylaxis is unknown. OBJECTIVES: To determine the prevalence of DVT among TBI patients. DESIGN, PARTICIPANTS AND SETTING: A prospective observational pilot study of adult patients admitted to the intensive care unit of a level 1 trauma centre within 72 hours of sustaining a TBI (Glasgow Coma Scale score _14). MAIN OUTCOME MEASURES: Rate of DVT determined using twice-weekly compression ultrasound; rate of pulmonary embolism (PE) and length of stay. RESULTS: 36 patients (28 men; mean age, 40.3 years) were included. Six had moderate and 21 had severe TBI. Two patients (6%) developed a DVT and two patients (6%) developed a PE. The proximal leg DVT rate was 3%, but the overall venous thromboembolism rate was 11% (4 patients). CONCLUSIONS: Mechanical and pharmacological prophylaxis appeared to be effective. The incidence of clinically identified PE is of concern and suggests that thromboembolic sources other than large leg veins may not be being adequately controlled by modern thromboprophylaxis regimens.

Short- and long-term retrievability of the Celect vena cava filter: results from a multi-institutional registry.

PURPOSE: To evaluate retrievability of the Celect vena cava filter over time and to assess the safety of the retrieval procedure in a prospective multicenter registry. MATERIALS AND METHODS: Between October 2005 and March 2008, Celect filters were placed in 95 patients (61 men; mean age, 51 years +/- 18.5) with a temporary need for an inferior vena cava (IVC) filter. All patients satisfied requirements for filter placement; the primary indications for placement were pulmonary embolism (PE) with a contraindication to or failure of anticoagulation (n = 40), high risk for further PE (n = 29), trauma (n = 23), or massive PE with residual deep vein thrombosis and risk for further PE (n = 3). Filter orientation, vena cava injury, and other device-related incidents were evaluated at implantation and retrieval. The degree of difficulty associated with retrieval was also assessed. RESULTS: Filter retrieval was attempted in 58 patients (mean indwell time of 179 days; median, 168.5 d; range, 5-466 d). Fifty-six filters (96.6%) were successfully retrieved. Unsuccessful retrieval attempts were attributed to filter tilt (n = 1) or excessive tissue growth with the hook embedded in the endothelium (n = 1). No adverse events were associated with the inability to retrieve these filters. A Kaplan-Meier product-limit survival estimate revealed that the probability of successful filter retrieval remained at 100% at 50 weeks and at more than 74% at 55 weeks after implantation. No adverse events were related to the retrieval procedures. CONCLUSIONS: Retrieval of the Celect filter was performed safely as long as 466 days after implantation.

Vertebroplasty in the management of traumatic burst fractures: a case series.

This study aimed to assess the role of percutaneous vertebroplasty (VP) in the management of acute traumatic burst fractures. We describe three cases where percutaneous VP was carried out for traumatic non-osteoporotic burst vertebral fractures. For clinical symptoms and the effect of the VP procedure to be assessed, all patients completed a visual analogue scale and a mobility score before the procedure and at day 1 and 3 months post procedure. Improvements in both pain and mobility scores immediately post procedure were seen in all patients, and these results persisted at 3-month follow up. Percutaneous VP provided a successful, minimally invasive treatment of these patients' traumatic fractures while avoiding major surgical procedures and associated surgical morbidity and complications.

Percutaneous management of high-output chylothorax: case reviews.

Chylothorax carries significant mortality and morbidity. Patients with high-output chylothorax have traditionally been managed by surgical treatment if nonoperative management has proved unsuccessful. Newer, more recent percutaneous techniques used to treat chylothorax are safer and less invasive than surgery. We present three cases that have been successfully managed using these percutaneous techniques.

Assessment of snared-loop technique when standard retrieval of inferior vena cava filters fails.

PURPOSE: To identify the success and complications related to a variant technique used to retrieve inferior vena cava filters when simple snare approach has failed. METHODS: A retrospective review of all Cook Günther Tulip filters and Cook Celect filters retrieved between July 2006 and February 2008 was performed. During this period, 130 filter retrievals were attempted. In 33 cases, the standard retrieval technique failed. Retrieval was subsequently attempted with our modified retrieval technique. RESULTS: The retrieval was successful in 23 cases (mean dwell time, 171.84 days; range, 5-505 days) and unsuccessful in 10 cases (mean dwell time, 162.2 days; range, 94-360 days). Our filter retrievability rates increased from 74.6% with the standard retrieval method to 92.3% when the snared-loop technique was used. Unsuccessful retrieval was due to significant endothelialization (n = 9) and caval penetration by the filter (n = 1). A single complication occurred in the group, in a patient developing pulmonary emboli after attempted retrieval. CONCLUSION: The technique we describe increased the retrievability of the two filters studied. Hook endothelialization is the main factor resulting in failed retrieval and continues to be a limitation with these filters.

Rendezvous technique following thermal ureteric injury after radiofrequency ablation in a solitary kidney.

Percutaneous radiofrequency (RF) ablation is a promising treatment for solid renal tumors in selected patients. Nontarget thermal damage is a known risk of the procedure. The authors describe a case of a patient who underwent RF ablation of a lower pole renal lesion and subsequently developed a ureteric stricture secondary to thermal injury. Successful management of the ureteric stricture required a rendezvous procedure. This report illustrates the potential complication of ureteric stricture formation after a RF ablation procedure and the management challenges posed by such thermal injuries.

Percutaneous embolization of transhepatic tracks for biliary intervention.

Significant pain can occur after removing transhepatic catheters from biliary access tracks, after percutaneous biliary drainage (PBD) or stenting. We undertook a randomized prospective study to ascertain whether track embolization decreases the amount of pain or analgesic requirement after PBD. Fifty consecutive patients (M:F, 22:28; age range: 29-85 years; mean age: 66.3 years) undergoing PBD were randomized to receive track embolization or no track embolization after removal of biliary drainage catheters. A combination of Lipoidol and n-butyl cyanoacrylate were used to embolize transhepatic tracks using an 8F dilator. The patients who did not have track embolization performed had biliary drainage catheters removed over a guide wire. A visual analog scoring (VAS) system was used to grade pain associated with catheter removal, 24 h afterward. A required analgesic score (RAS) was devised to tabulate the analgesia required. No analgesia had a score of 0, oral or rectal nonopiate analgesics had a score of 1, oral opiates had a score of 2, and parenteral opiates had a score of 3. The average VAS and RAS for both groups were calculated and compared. Seven patients were excluded for various reasons, leaving 43 patients in the study group. Twenty-one patients comprised the embolization group and 22 patients comprised the nonembolization group. The mean biliary catheter dwell time was not significantly different (p > 0.05) between the embolization group and nonembolization (mean: 5.4 days vs 6.9 days, respectively). In the nonembolization group, the mean VAS was 3.4. Eight patients required parenteral opiates, three patients required oral opiates, and five patients required oral or rectal analgesics, yielding a mean RAS of 1.6. In the embolization group, the mean VAS was 0.9. No patient required parenteral opiates, six patients required oral opiates, and two patients had oral analgesia. The average RAS was 0.6. Both the VAS and the RAS were significantly lower in the embolization group compared with the nonembolization group (p < 0.0023 and p < 0.002, respectively). No complications were seen related to track embolization. Percutaneous track embolization after removal of biliary drainage catheters decreases patient's perception of pain and decreases the amount of required analgesia. In particular, the amount of opiate analgesia required is considerably less.

Uterine artery embolisation - a treatment alternative for women with fibroids.

BACKGROUND: Fibroids are a common benign tumour of the female reproductive tract. Uterine artery embolisation is a minimally invasive catheter based technique that compares favourably with surgical treatments. OBJECTIVE: Uterine artery embolisation is an intervention that is especially suited to women who wish to preserve their uterus. This article briefly outlines the medical and surgical treatment options for fibroids with an in depth focus on fibroid embolisation. DISCUSSION: Australian interventional radiologists have been performing uterine artery embolisation for fibroid disease successfully for a number of years. This procedure - like any intervention - is not without complication, but it does enable women a valid alternative treatment pathway for fibroids. General practitioners can discuss the procedure with their local interventional radiologist and can foster a broader understanding of the process with their female patients when considering treatment options.

Percutaneous gastrostomy and gastrojejunostomy.

Gastrostomy allows enteral nutrition to continue in patients who are unable to meet their caloric requirements orally. Though the indications for gastrostomy placement are varied, dysphagia secondary to a neurological condition is the most common. These catheters were initially placed surgically, but percutaneous endoscopic placement is now the routine in most centers. Interventional radiologists have been performing this procedure under fluoroscopic guidance for several years with encouraging results. Percutaneous radiological gastrostomy is reported to have a success rate comparable to that of the endoscopic method, with lower morbidity and mortality rates. A further benefit is that it may be performed in patients for whom the endoscopic method would be difficult or dangerous, such as those with head and neck malignancies. One of the main factors currently limiting the use of this procedure is the shortage of interventional radiology facilities and specialists.This article describes a technique for routine percutaneous radiological gastrostomy catheter placement and procedural variations for difficult cases. Indications and contraindications will be discussed, as will complication rates and how these compare with the traditional methods of gastrostomy tube placement.

De novo placement of button gastrostomy catheters in an adult population: experience in 53 patients.

PURPOSE: To investigate the feasibility of primary button gastrostomy insertion with the aid of T-fastener gastropexy. MATERIALS AND METHODS: Fifty-three consecutive patients (33 men, 20 women; mean age, 63.4 years) referred for percutaneous radiologic gastrostomy (PRG) underwent primary button gastrostomy insertion over an 18-month period in two centers. Nine of the patients (17%) were referred after failed endoscopic gastrostomy and 44 (83%) were primarily referred for PRG. Indications for gastrostomy included esophageal/head and neck malignancy (n = 33) and neurologic disorders (n = 20). Gastropexy with three or four T-fasteners was performed in all patients and angioplasty balloon catheters (6 mm x 40 mm) were used to measure tract length and dilate the tract. An 18-F dilator was used for final tract dilation. Button gastrostomy catheters with retention balloons were inserted in all patients. Patient follow-up was performed by the department of dietetics, which contacted patients on a weekly basis. RESULTS: Primary button gastrostomy insertion was successful in 52 of 53 patients (98%). The mean gastrostomy button catheter survival was 13.3 weeks (range, 1-28 weeks). No episodes of button occlusion occurred. Since the beginning of this study, 33 patients (63%) have had their gastrostomy buttons replaced. The reasons for button replacement include burst retention balloons (n = 27; 52%), dislodgment of the catheter (n = 4; 8%), and continuing pain/discomfort at the gastrostomy site (n = 2; 4%). CONCLUSION: Button-type gastrostomy catheters can be placed de novo by interventional radiologists without the need for a mature tract, provided a T-fastener gastropexy is used. The balloon retention button devices are not compromised by occlusion but do tend to become dislodged.