Randomized Controlled Trial of Percutaneous Radiologic Gastrostomy Performed With and Without Gastropexy: Technical Success, Patient-Reported Outcomes and Safety.

PURPOSE: The aim of this study is to compare balloon-retention percutaneous radiologic gastrostomy (PRG) tube insertion performed with and without gastropexy, primarily focusing on pain and patient-reported outcomes. MATERIALS AND METHODS: Research ethics board approved a dual-arm, single-centre, randomized trial of 60 patients undergoing primary 14-French PRG tube insertion (NCT04107974). Patients were randomized to receive either PRG with gastropexy or without gastropexy. Data were collected for technical outcomes, patient-reported outcomes pre-procedure, post-procedure and at 1-month, as well as quality of life parameters at 1-month post-procedure (EQ5D-5L, Visual Analogue Scale and Functional Assessment of Cancer Therapy-Enteral Feeding questionnaires). Complications occurring up to 6-months post-procedure were recorded. RESULTS: Sixty patients were randomized to the gastropexy group (n = 30) or non-gastropexy (n = 30) group. One non-gastropexy patient was withdrawn from the study due to failed insertion. PRG procedural time was significantly longer when using gastropexy (mean 11.4 ± 7.19 min) compared with non-gastropexy (mean 6.79 ± 4.63 min; p < 0.05). Pain scores did not differ between the two groups pre-procedure, post-procedure and at 1-month follow-up, nor did 1-month quality of life parameters. Six (20%) minor complications occurred in the gastropexy group and nine (31%) minor complications in the non-gastropexy group (p = 0.330). Two (6.9%) major complications occurred in the non-gastropexy group (p = 0.458). CONCLUSION: There is comparable patient tolerability when balloon-retention PRG insertion is performed with or without gastropexy sutures. This study also demonstrated a trend towards fewer complications when gastropexy is utilized. However, further larger trials are required to compare complications of the two approaches for PRG insertion. LEVEL OF EVIDENCE: Level 2, randomized trial.

Direct sac puncture versus transarterial embolization of type II endoleaks: An evaluation and comparison of outcomes.

Purpose To determine the outcomes of type II endoleak embolization with aneurysm sac obliteration and whether the approach - direct sac puncture or transarterial - affects outcome. Methods A retrospective review of patients who underwent endovascular aneurysm repairs and subsequent type II endoleak embolization over 10 years was performed. Twenty-three patients (median age: 73 years, range: 40-88 years) underwent 35 embolizations. Embolization was performed with the goal of obliterating both the endoleak sac and feeding vessels. Embolization agents used include cyanoacrylate glue only (48%), glue and coils (36%), coils only (13%), and other (3%). Results Mean follow-up was 21.8 months. Patients underwent an average of 1.5 embolizations, with 35% requiring more than one. Technical success rate was 89%. Freedom from aneurysm sac expansion was achieved in 91%. Freedom from type II endoleak was accomplished in 70%. There were no ruptured aneurysms during the follow-up period. Direct sac puncture and transarterial approaches had similar incidences of aneurysm sac growth ( p = 0.74), persistent type II endoleak ( p = 0.32), and complications ( p = 0.64). However, direct sac puncture had significantly shorter fluoroscopy ( p < 0.001) and total procedure times ( p < 0.001) than transarterial embolizations. Conclusion Direct sac puncture and transarterial embolization of type II endoleak with aneurysm sac obliteration are similarly effective for the prevention of aneurysm sac growth. However, direct sac puncture is our preferred approach given its significantly shorter fluoroscopic and procedural times.

Randomized Trial Comparing Radiologic Pigtail Gastrostomy and Peroral Image-Guided Gastrostomy: Intra- and Postprocedural Pain, Radiation Exposure, Complications, and Quality of Life.

PURPOSE: To prospectively compare radiologically created pigtail gastrostomy (PG), in which the tube is inserted directly through the abdominal wall, versus peroral image-guided gastrostomy (POG), in which the tube is inserted through the mouth. Pain profiles (primary outcome measure), fluoroscopy times, total room times, technical success, complications, and quality of life (QOL) were measured. MATERIALS AND METHODS: Sixty patients were prospectively randomized to receive 14-F PG or 20-F POG tubes. All patients received prophylactically created gastrostomies before radiation therapy for head and neck squamous-cell carcinoma. Patients receiving palliative treatment were excluded, as were those with established pharyngeal obstruction. Pain was measured by numeric rating scale (NRS) scores for 6 weeks after the procedure and by intraprocedural fentanyl and midazolam doses and postprocedural 24-h morphine doses. Fluoroscopy times, total room times, technical success, complications up to 6 months, and gastrostomy-related QOL (using the Functional Assessment of Cancer Therapy-Enteral Feeding questionnaire) were determined. RESULTS: Fifty-six patients underwent the randomized procedure. The POG group required significantly higher intraprocedural midazolam and fentanyl doses (mean, 1.2 mg and 67 µg, respectively, for PG vs 1.9 mg and 105 µg for POG; P < .001) and had significantly longer fluoroscopy times (mean, 1.3 min for PG vs 4.8 min for POG; P < .0001). NRS scores, morphine doses, total room times, technical success, complication rates, and QOL did not differ significantly between groups. The one major complication, a misplaced PG in the peritoneal cavity, followed a technical failure of POG creation. CONCLUSIONS: Despite the differences in insertion technique and tube caliber, the measured outcomes of POG and PG are comparable.

Efficacy of Ovarian Artery Embolization for Uterine Fibroids: Clinical and Magnetic Resonance Imaging Evaluations.

PURPOSE: The objective of the study was to assess the efficacy of ovarian artery embolization (OAE) treatment for symptomatic uterine leiomyomas. METHODS: A retrospective review of 17 patients who underwent OAE in conjunction with uterine artery embolization in a 6-year period (2006-2012) was performed. Ten patients had previous failed embolization, while 7 had not received any embolization therapy before. Percent uterine volume change, percent dominant fibroid volume change, and percent dominant fibroid infarction were assessed with magnetic resonance (MR) imaging. Resolution of menorrhagia, dysmenorrhea/pain, and bulk and/or pressure symptoms including urinary frequency were evaluated clinically. Change in menopausal state was also an outcome of interest. RESULTS: Mean MR imaging follow-up was performed 3 months post-OAE. MR images showed complete infarction in the majority of cases (64.7%; n = 11), with infarction rates of 90%-100% in 3 cases, 1 case with 30%-50% infarction, and 2 cases with 0%-10% infarction. Average uterine size reduction on MR was 32.3% (95% confidence interval [CI]: 22.5%-42.2%; P < .001). The average size reduction for the dominant fibroid was 42.4% (95% CI: 27.7%-57.0%; P = .01). The mean time to final follow-up visit was 11 months. At this point complete symptom resolution (menorrhagia, dysmenorrhea and bulk-related) was achieved in 82.4% (n = 14) of cases. At the final follow-up 11.8% (n = 2) of cases reported menopause. CONCLUSIONS: We observed OAE to be an effective and safe adjunct to uterine artery embolization when hypertrophic ovarian artery(ies) require intervention. However, incomplete fibroid infarction of 23% remains a concern with a potential for long-term treatment failure. In addition, long-term effect on ovarian function is uncertain.

Radiofrequency ablation of hepatocellular carcinoma as a bridge to liver transplantation.

BACKGROUND: Radiofrequency ablation (RFA) of hepatocellular carcinoma (HCC) is widely utilized as a bridge to liver transplant with limited evidence to support efficacy. The purpose of the present study was to measure the effect of RFA on time to drop-off in HCC-listed patients. METHODS: Patients with Milan criteria tumours listed between January 1999 and June 2007 were stratified into RFA (n= 77) and No Treatment groups (n= 93). RESULTS: The primary effectiveness of RFA was 83% (complete radiographic response). RFA was associated with a longer median wait time to transplant (9.5 vs. 5 months). Tumour-specific drop-off events were equivalent between RFA (21%) and No Treatment (12%) groups (P= 0.11). Controlling for wait time, there was no difference in overall (P= 0.56) or tumour-specific drop-off (P= 0.94). Furthermore, there were no differences in 5-year overall or tumour-free survivals from list date or transplant. Using multivariate analysis, the likelihood of receiving a transplant and patient survivals were associated with tumour characteristics (AFP, tumour number and size) and not with bridge therapy or waiting time. DISCUSSION: RFA allows patients to be maintained longer on the waiting list without negative consequences on drop-off or survival compared with no treatment. Post-transplant outcomes are affected more by tumour characteristics than RFA or wait time.

Outcomes after uterine artery embolization for pedunculated subserosal leiomyomas.

PURPOSE: To assess the safety and efficacy of uterine artery embolization (UAE) treatment of pedunculated subserosal leiomyomas. MATERIALS AND METHODS: A review of patients undergoing UAE in a 30-month period (July 2004 to December 2006) was performed. Cases in which a pedunculated subserosal tumor (volume>or=4 cm3) was embolized were analyzed. The preprocedural volumes of the pedunculated tumor and uterus and the diameter and vascularity of the tumor and stalk were recorded. Posttreatment sizes of the pedunculated leiomyoma, stalk, and uterus were recorded, as was the presence or absence of complication(s). RESULTS: A total of 240 patients underwent embolization. Pedunculated subserosal leiomyomas were treated in 16 women, with a technical success rate of 100%. Preprocedural mean tumor and uterine volumes were 372 cm3 and 789 cm3, respectively. The mean stalk diameter was 2.7 cm (range, 0.8-7.8 cm). All pedunculated leiomyomas exhibited enhancement on contrast agent-enhanced magnetic resonance (MR) imaging (n=13) or vascularity on Doppler ultrasonography (US; n=3). Stalk vascularity was noted on MR imaging in 13 patients and was not assessed in the remaining three, who underwent US imaging. Imaging follow-up (mean, 5.9 months after UAE) demonstrated mean tumor volume reduction of 39.3% (95% confidence interval [CI], 28.2%-50.5%) and mean uterine volume reduction of 37.6% (95% CI, 26%-49.3%). There were no cases of continued tumor perfusion and no major complications. There was one minor complication of prolonged hospital stay (36 hours) for pain control. CONCLUSION: UAE was successfully and safely performed for pedunculated subserosal leiomyomas, with a tumor volume reduction of 39% and no unique complications related to these lesions.

Clinical failure after uterine artery embolization: evaluation of patient and MR imaging characteristics.

PURPOSE: To investigate the patient and magnetic resonance (MR) imaging characteristics associated with clinical failure after uterine artery embolization (UAE). MATERIALS AND METHODS: Seventy-eight consecutive patients who underwent UAE were examined. Contrast-enhanced MR imaging was performed before and 4 months after the procedure, and clinical follow-up was performed at 15 months. Patients were divided into success and failure groups strictly on the basis of their clinical outcomes. Clinical follow-up included evaluation of fibroid symptoms and the need for further treatment after UAE. Findings at pre- and postprocedural MR imaging were compared, and data collected included changes in uterine and fibroid volumes, fibroid location, and fibroid perfusion. RESULTS: Fifty-eight patients were placed into the success group and 20 into the failure group. There were no differences between the baseline characteristics of the two groups. The reduction in uterine and dominant fibroid volumes was greater in the success group compared with the failure group; however, the difference was not statistically significant (success group: [295/845] 34.9% vs [80/282.5] 28.3%, respectively, P=.18; failure group: [317/733] 43.2% vs [114/337.6] 33.9%, P=.32). The reduction in total fibroid volume was greater in the success group than the failure group ([189.6/393.5] 48.2% vs [148.7/439.9] 33.8%, respectively; P=.02) despite the fact that the percentage of fibroids completely infarcted was similar between the two groups ([136/172] 79% vs [41/50] 82%, P=.77). Pedunculated subserosal fibroids were more common in the failure group than in the success group (P<.03) and did not reduce in volume as significantly (53.8% vs 14.7%, respectively; P=.02). CONCLUSIONS: In general, the reduction in total fibroid volume after embolization is smaller in patients with poor clinical improvement. In addition, these patients have a higher number of pedunculated subserosal fibroids, and these fibroids tend to reduce in volume to a lesser extent.

A rare etiology of delayed postpartum hemorrhage.

BACKGROUND: Postpartum hemorrhage, immediate or delayed, is a leading cause of maternal death. The most common etiologies are retained products of conception, infection, and subinvolution of the placental implantation site. CASE: A 31-year-old woman, gravida 1, para 0, had an uneventful pregnancy after infertility treatment. She was delivered by intrapartum Caesarean section because of arrest of descent. Twelve days after delivery she had profuse, intermittent vaginal bleeding, but physical examination and pelvic ultrasound failed to reveal the cause. Angiography was performed and showed a left uterine artery pseudoaneurysm that was successfully treated with arterial embolization. CONCLUSION: Use of uterine angiography and embolization at an early stage in the search for the etiology of postpartum hemorrhage helps to decrease morbidity and mortality.

Complex right subclavian artery dissection during diagnostic cardiac catheterization.

Vascular complications are important and unfortunate sequelae of cardiac catheterization. We report a case of complex right subclavian artery dissection following attempted diagnostic cardiac catheterization of a right internal mammary artery (RIMA) coronary bypass graft. Subsequent dissection of the right subclavian artery involved the origin of the right vertebral and internal mammary arteries, as well as producing critical right upper limb ischemia. The anatomy dictated that therapy consist of conservative management of the proximal dissection involving the vertebral artery and the RIMA graft origins, with endovascular stent deployment at the distal site of the vessel occlusion. This example reinforces the need for prompt diagnosis and management of vascular complications, and emphasizes the need for available, appropriate skills relevant to the peripheral vascular interventions.

Ultrahigh-pressure versus high-pressure angioplasty for treatment of venous anastomotic stenosis in hemodialysis grafts: is there a difference in patency?

PURPOSE: Ultrahigh-pressure (UHP) balloon catheters were compared with high-pressure (HP) balloon catheters to determine if there was a difference in patency after percutaneous transluminal angioplasty (PTA) of venous anastomotic stenoses. MATERIALS AND METHODS: A retrospective study was conducted from January 2001 to September 2005 that included 22 patients with synthetic hemodialysis grafts who underwent 110 PTA procedures for venous anastomotic stenoses. Data collected included graft configuration and location, percent stenosis, balloon type used, residual stenosis, and total access blood flow before and after intervention. Patency from time of initial PTA to the next intervention was estimated with the Kaplan-Meier technique, with initial failures included in the analysis. RESULTS: A total of 55 PTAs were performed in each group. Technical success rate was 96% (n = 106) and clinical success rate was 100%. Median survival times were 4.6 months for the UHP cohort and 5.4 months for the HP group. When each event was considered independent, the difference was significant (P = .014). However, when each PTA event was considered dependent on earlier PTA events, no significant difference in patency was observed (P = .64). The mean increases in access blood flow rate by ultrasound dilution (available for 71 events) after PTA were 264 mL/min with UHP and 524 mL/min with HP (P = .14, Student t test). One minor complication (0.9%) of focal extravasation after PTA occurred and resolved with prolonged balloon inflation. CONCLUSION: Routine use of UHP for PTA of venous anastomotic stenoses in synthetic hemodialysis grafts was not associated with any significant change in patency compared with routine HP balloon angioplasty.

Patency of endovascular treatment for central venous stenosis: is there a difference between dialysis fistulas and grafts?

PURPOSE: To determine if there is a difference in intervention patency for central venous stenosis (CVS) and occlusion between patients with autogenous hemodialysis fistulas and those with grafts. MATERIAL AND METHODS: A retrospective study was performed from March 1998 to September 2005 identifying all patients with autogenous fistulas and synthetic grafts who underwent percutaneous angioplasty and/or stent placement for CVS. This study cohort consisted of 38 patients (22 with fistulas and 16 with grafts). Age, sex, type of access, location and side of the access, location and side of the CVS, presence of diabetes, previous hemodialysis catheter placement, date and type of interventions, and outcomes were recorded. The patency of each intervention was estimated by using the Kaplan-Meier survival curves. Univariate and multivariate analysis of the variables were performed. RESULTS: Eighty-nine interventions were performed; 83 were angioplasties and six were stent placements. Previous catheter placement on the side of the CVS occurred in 29 of the 38 patients (76%). Technical and clinical success of the interventions were 93.3% and 94.4% respectively. The intervention or primary patency rates +/- standard errors at 3, 6, and 9 months in the fistula group were 88.5% +/- 4.8, 59.4% +/- 7.6, and 46% +/- 7.9, respectively. In the graft group, the rates were 78.1% +/- 7.3, 40.7% +/- 9, and 16% +/- 7.3, respectively. With multivariate analysis, intervention patency remained significantly longer for fistulas (P .014) and in patients who did not have a previous catheter (P .001). CONCLUSION: Longer intervention-free survival for CVS was observed in patients with autogenous fistulas compared with grafts and in patients who did not previously undergo hemodialysis catheter insertion.

Transplant renal artery stenosis: outcome after percutaneous intervention.

PURPOSE: To assess the outcome of percutaneous transluminal angioplasty (PTA) and stent placement as the primary treatment for transplant renal artery stenosis (TRAS). MATERIALS AND METHODS: A retrospective review of PTA and stent placement procedures performed for TRAS from April 1997 to July 2003 was conducted. Reviewed parameters included technical success, date of transplantation, dates of percutaneous intervention, mean arterial blood pressure, number of blood pressure medications, and serum creatinine level before and after intervention. Twenty-one interventions were performed in 18 allografts. The primary clinical indication for imaging and treatment was increased creatinine level in 12 allografts and hypertension in six allografts. Patency rates were estimated with use of the Kaplan-Meier method. RESULTS: The technical success rate of PTA/stent placement was 100% and the clinical success rate was 94% (17 of 18 allografts). Thirteen interventions involved PTA alone, with eight combined PTA and stent insertions. The mean preintervention serum creatinine level among 12 allografts presenting with elevated creatinine levels was 2.8 mg/dL +/- 1.4 (SD), compared with a 1-month postintervention mean of 2.2 mg/dL +/- 0.7 (P = .03). Of six allografts that presented with hypertension, significant improvement was seen between the preintervention and 1-month postintervention mean systolic (174 mm Hg vs 135 mm Hg, P = .003) and diastolic (99 mm Hg vs 82 mm Hg, P = .02) pressures. These patients required a mean of 2.3 medications for blood pressure control before intervention, compared with a mean of 1.0 medications at 1 month after intervention (P = .002). Primary patency rates at 3, 6, and 12 months (+/-95% CI) were 94% +/- 6%, 72% +/- 12%, and 72% +/- 12%, respectively. Secondary patency rates at 3, 6, and 12 months (+/-95 CI) were 100%, 85% +/- 10%, and 85% +/- 10%, respectively. Mean follow-up time was 27 months. Of the eight allografts that underwent stent placement, all eight remained patent at last follow-up (mean, 18.3 months +/- 9.2). One major complication of a puncture site pseudoaneurysm occurred (5%). CONCLUSION: Primary treatment of TRAS with PTA with or without stent placement has good intermediate-term patency and is associated with significant early improvement in blood pressure and creatinine level.

Arterial port catheter system placement using a translumbar aortic route.

RATIONALE AND OBJECTIVES: Implantable ports for arterial infusion hold promise in a growing number of clinical applications, including regional chemotherapy and gene therapy. Percutaneous placement of arterial infusion ports has been described clinically; however, existing sites of access pose unique anatomic challenges. The feasibility of translumbar aortic placement of a port-catheter system for long-term arterial infusion was assessed. MATERIALS AND METHODS: Eight swine underwent placement of a percutaneously implantable arterial port-catheter system using a translumbar aortic approach for catheter placement. The tip of the catheter was positioned in the left or right hepatic artery and the port reservoir implanted in the paraspinal subcutaneous tissues. Patency and position of the port-catheter system were assessed at 7 to 10 days and 28 days. The insertion procedure was modified in two animals by introducing tissue adhesive around the catheter to prevent dislodgment. RESULTS: Immediate technical success was achieved in 6 of 8 animals (75%). Catheters were dislodged into the aorta in two animals on the day of the procedure, extravascular in four animals and intra-aortic in one animal by day 10. One animal died at 21 days of sepsis. The port-catheter systems remained functional at 28 days with catheters positioned within the left or right hepatic artery in three animals, including two animals in which the catheter had been fixated within the paraspinal soft tissues with tissue adhesive. CONCLUSIONS: A translumbar aortic route for percutaneous placement of arterial infusion port-catheter systems is feasible in swine and holds potential as an ancillary access site in a clinical setting if the obstacle of catheter fixation can be overcome.