Onyx versus coil embolization for the treatment of type II endoleaks.

OBJECTIVE: Little evidence is available supporting the optimal treatment of type II endoleaks associated with aortic sac growth. Previous studies have lacked comparisons between treatment methods and long-term follow-up. The purpose of the present study was to review our center's experience with the treatment of type II endoleaks comparing Onyx (a liquid embolization agent consisting of ethylene vinyl alcohol; Medtronic, Minneapolis, Minn) embolization and coil embolization. METHODS: A retrospective review of prospectively collected data from a vascular surgery database was performed to identify all patients who had undergone embolization of a type II endoleak for aortic sac growth after endovascular aneurysm repair from 2005 to 2018. The Onyx and coil embolization groups were compared using univariate statistics. RESULTS: A total of 58 patients had undergone 77 embolization procedures for type II endoleaks with either Onyx (27 patients; 37 procedures) or coils (31 patients; 40 procedures). The average aneurysm size at embolization was larger in the Onyx group (77.9 ± 15.1 mm) compared with coil embolization (73.4 ± 11.9 mm). The mean follow-up was 57 months for the Onyx group and 74 months for the coil embolization group. Of the 27 patients who had undergone Onyx embolization, 2 (7.4%) had required graft explantation compared with 5 of the 31 patients (16.1%) who had undergone coil embolization (P = .33). The results of the per-patient analysis showed that the coil embolization group had a significantly greater rate of the need for further reintervention compared with the Onyx group (55% vs 19%; P < .01). Clinical success was observed in 13 patients (48%) in the Onyx embolization group compared with 10 patients (32%) in the coil embolization group (P = .04). Two patients in each group had presented with secondary rupture of the aneurysm sac after attempted embolization. CONCLUSIONS: Type II endoleaks associated with sac growth treated with Onyx were less likely to require further reinterventions than were those treated with coil embolization. A trend was found toward a greater need for endovascular aneurysm repair explant after coil embolization. With a high rate of further reintervention and potential for sac rupture, diligent follow-up is required after attempted type II embolization, regardless of the technique used.

Percutaneous Ultrasound Gastrostomy: First-in-Human Experience with the PUMA-G System.

Percutaneous ultrasound gastrostomy (PUG) technique was developed to allow for gastrostomy tube insertion to be performed solely under ultrasound guidance without need for fluoroscopy or endoscopy. This report discusses the new device, proposed PUG technique, and the first-in-human experience. Five patients had PUG tube insertion performed as part of a Health Canada approved investigational study. All procedures were successful with no complications within 30 days postprocedure. Mean total procedure time was 50 ± 13 minutes. Two of 5 procedures required temporary fluoroscopy use to localize the orogastric balloon position within the stomach to achieve magnetic gastropexy.

Percutaneous ultrasound gastrostomy (PUG): first prospective clinical trial.

GRAPHICAL ABSTARCT: PURPOSE: To report the results of the first-in-human trial evaluating the safety and efficacy of the percutaneous ultrasound gastrostomy (PUG) technique. METHODS: A prospective, industry-sponsored single-arm clinical trial of PUG insertion was performed in 25 adult patients under investigational device exemption (mean age 64 ± 15 years, 92% men, 80% inpatients, mean BMI 24.5 ± 2.7 kg/m2). A propensity score-matched retrospective cohort of 25 patients who received percutaneous radiologic gastrostomy (PRG) was generated as an institutional control (mean age 66 ± 14 years, 92% men, 80% inpatients, mean BMI 24.0 ± 2.7 kg/m2). Primary outcomes included successful insertion and 30-day procedure-related adverse events (AE's). Secondary outcomes included procedural duration, sedation requirements, and hospital length of stay. RESULTS: All PUG procedures were successful, including 3/25 [12%] performed bedside within the ICU. There was no significant difference between PUG and PRG in rates of mild AE's (3/25 [12%] for PUG and 7/25 [28%] for PRG, p = 0.16) or moderate AE's (1/25 [4%] for PUG and 0/25 for PRG, p = 0.31). There were no severe AE's or 30-day procedure-related mortality in either group. Procedural room time was longer for PUG (56.5 ± 14.1 min) than PRG (39.3 ± 15.0 min, p < 0.001). PUG procedure time was significantly shorter after a procedural enhancement, the incorporation of a Gauss meter to facilitate successful magnetic gastropexy. Length of stay for outpatients did not significantly differ (2.4 ± 0.5 days for PUG and 2.6 ± 1.0 days for PRG, p = 0.70). CONCLUSION: PUG appears effective with a safety profile similar to PRG. Bedside point-of-care gastrostomy tube insertion using the PUG technique shows promise. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov ID NCT03575754.

Retrievable inferior vena cava filter for primary prophylaxis of pulmonary embolism in at-risk trauma patients: A feasibility trial.

OBJECTIVE: To determine if insertion of rIVCF for PE prophylaxis in high risk trauma patients could result in a clinically meaningful reduction (>24 h) in time that patients are left unprotected from PEs SUMMARY AND BACKGROUND DATA: Trauma patients are at high risk for the development of pulmonary embolism (PE). Early pharmacologic PE prophylaxis is ideal, however many patients are unable to receive prophylaxis due to concomitant injuries. Current guidelines are conflicting on the role of prophylactic retrievable inferior vena cava filters (rIVCF) for PE prevention in this patient population, and robust data to guide clinicians is lacking. METHODS: In this single center, randomized control trial of adult (age > 18 years) trauma patients at high risk for PE by EAST criteria and unable to receive pharmacologic prophylaxis for at least 72 h, we randomized 42 patients to receive a rIVCF or to not have a rIVCF placed. Our primary endpoints were time left unprotected to PE development and feasibility. RESULTS: The median patient age was 53 years, with a median Injury Severity Score of 33. Randomization to rIVCF reduced the time left unprotected to PE (Control: 78.2 h [53.6-104]; rIVCF: 25.5 h [9.8-44.6], p = 0.0001). Two pulmonary embolisms occurred in the control group, and one in the rIVCF group. Seven deaths occurred in the control group, and 8 in the rIVCF group. CONCLUSION: This feasibility study demonstrates a clinically meaningful reduction in time left unprotected to PE. Further investigations powered to demonstrate a reduction in PE incidence are required. LEVEL OF EVIDENCE: Level 1 Evidence randomized controlled trial.

Proximal splenic artery embolization in the management of splenic rupture.

OBJECTIVE: To report the use of proximal splenic artery embolization for management of spontaneous splenic rupture. DESIGN: Case report and literature review. SETTING: A tertiary pediatric critical care unit in a university teaching hospital. INTERVENTIONS: Proximal splenic artery embolization. MEASUREMENTS AND MAIN RESULTS: An 8-yr-old boy presented with abdominal pain radiating to the left shoulder 9 days after completing induction chemotherapy for acute lymphoblastic leukemia. Imaging revealed a splenic rupture with parenchymal and subcapsular hematomas, with no evidence of active extravasations. The patient was admitted to the pediatric critical care unit for close hemodynamic monitoring and frequent measurements of hemoglobin. His lowest recorded hemoglobin and hematocrit were 63 g/L and 0.19 L/L, respectively. Posttransfusion of packed red blood cells, he was taken to interventional radiology for proximal splenic artery embolization under moderate sedation. Several coils were successfully placed in the proximal splenic arterial system resulting in a marked reduction of splenic blood flow without disruption of collaterals. The patient recovered well from proximal splenic artery embolization in the pediatric critical care unit and experienced short lasting abdominal pain and fever for 1 day. He was discharged home 4 days after the procedure and follow-up imaging showed resolving hematomas with preserved splenic blood flow. CONCLUSION: Proximal splenic artery embolization in children may be a safe therapeutic alternative to either conservative or surgical management in spontaneous splenic rupture. Preservation of splenic tissue with a reduced risk of repeated hemorrhage can be obtained with proximal splenic artery embolization.

Complementary roles of low-dose SPECT-CT and high-resolution volume CT for detection of coronary artery disease.

A 70-year-old woman with a high pretest likelihood of coronary artery disease (CAD) underwent a Tc-99m MIBI SPECT-CT study for myocardial perfusion imaging (MPI), which was complemented by a high-resolution volume CT (VCT) study. After attenuation correction, an MPI pattern of ischemia was detected in the lateral wall of the myocardium. The CT calcium score (CTCS) was above the 75th percentile. The CT angiography (CTA) demonstrated a 70% stenosis at the ostial part of the circumflex artery, and incidentally revealed a saccular aneurysm. In today's nuclear cardiology, low-dose SPECT-CT plus high-resolution VCT allows anatofunctional assessment of suspected CAD.

Midterm results of endovascular infrarenal abdominal aortic aneurysm repair in high-risk patients.

Short-term and midterm clinical outcomes after endovascular repair of abdominal aortic aneurysms (AAAs) have been well documented. Evaluation of longer term outcomes is now possible. Here we describe our initial 100 high-risk patients treated with endovascular aneurysm repair (EVAR), all with a minimum of 5 years of follow-up. A retrospective review of prospectively recorded data in a departmental database was undertaken for the first 100 consecutive EVAR patients with a minimum of 5 years (range, 60-105 months) of follow-up performed between December 1997 and June 2001. Information was obtained from surgical follow-up visits and family doctors' offices. Endovascular repair of AAA in high-risk patients can be achieved with acceptably low postoperative mortality and morbidity. Longer term results in this high-risk cohort suggest that EVAR is effective in preventing aneurysm-related deaths at 5 years and beyond. All late mortalities were due to patients' comorbid diseases.

Strategies to reduce line infections in a small child with homozygous familial hypercholesterolaemia who cannot yet receive LDL apheresis.

Patients with homozygous familial hypercholesterolaemia are optimally treated with low-density lipoprotein apheresis. Young patients who do not meet a weight threshold (25 kg) receive regular plasmapheresis. This approach may remove excessive immunoglobulins and vascular access set-up can be challenging. We report the case of a 4 year-old child who exhibited repeated septic infections (5 in 6 months) and had recurrent access issues before two interventions were implemented: (1) the percutaneous central venous line was modified to two implanted paediatric ports, and (2) the patient started receiving two bags of Octaplasma at the end of each plasmapheresis treatment to account for the excessive loss of immunoglobulins. For the paediatric plasmapheresis access port, a 19-gauge Huber needle had to be used for the arterial port to prevent the collapse of the extension. These two simple changes have left the patient infection-free for 9 months.

Fibrinogen Level and Bleeding Risk During Catheter-Directed Thrombolysis Using Tissue Plasminogen Activator.

PURPOSE: The purpose of this study was to determine whether low fibrinogen levels (fibrinogen level <1.5 g/L) during catheter-directed thrombolysis are associated with an increased bleeding risk. METHODS: A retrospective review was performed on patients undergoing extremity arterial or venous thrombolysis between 2005 and 2013. RESULTS: Patients in the low fibrinogen group were younger (P = .006) and had a higher number of venous occlusive events (P = .004). The low fibrinogen group received a larger dose of tissue plasminogen activator (tPA; P = .009) and had a longer duration of thrombolysis (P = .010). The rates of major bleeding were not significantly different (P = .139). Univariate analysis showed that larger total dose and longer duration of tPA infusion were associated with increased bleeding complications (P < .01 and P = .03). CONCLUSION: A fibrinogen level <1.5 g/L during thrombolysis was not associated with an increased bleeding risk. However, larger dose and longer duration of thrombolysis were associated with increased bleeding risk.

Delayed hemorrhagic complications in the nonoperative management of blunt splenic trauma: early screening leads to a decrease in failure rate.

BACKGROUND: Delayed splenic rupture is the Achilles' heel of nonoperative management (NOM) for blunt splenic injury (BSI). Early computed tomographic (CT) scanning for features suggesting high risk of nonoperative failure, splenic pseudoaneurysms (SPAs), and arterial extravasation (AE), in concert with the appropriate use of splenic arterial embolization (SAE) is a viable method to reduce rates of failure of NOM. We report our 12-ear experience with a protocol for mandatory repeat CT evaluation at 48 hours and selective SAE. METHODS: A retrospective cohort analysis was performed on all consecutive adult trauma patients with BSI between 1995 and 2012. We evaluated an early/control (1995-1999) and a present/intervention (2000-2012) cohort in which SAE became available and 48-hour CT scans were implemented. RESULTS: The study included 773 patients (157 early vs. 616 present) with BSI. The proportion of patients managed nonoperatively (53% vs. 77%, p < 0.01) and overall splenic salvage rate (46% vs. 77%, p < 0.01) were improved in the present cohort. Among patients selected for NOM, there was a significant improvement in the failure rate of NOM (12% vs. 0.6%, p < 0.01) as well as in the length of hospital stay (8 days vs. 6 days, p < 0.01). Delayed development of SPA and/or AE was detected in 6% of BSI in the present cohort and was distributed among all grades of injury. CONCLUSION: The delayed development of SPA and AE is not an entirely rare event following BSI. Reevaluation with CT at 48 hours following admission and the use of SAE significantly decrease the failure rate of NOM. LEVEL OF EVIDENCE: Therapeutic study, level III.

Surveillance and medical therapy following endovascular treatment of chronic cerebrospinal venous insufficiency.

The debate regarding the possible link between chronic cerebrospinal venous insufficiency and multiple sclerosis (MS) is continuously becoming more and more contentious due to the current lack of level 1 evidence from randomized trials. Regardless of this continued uncertainty surrounding the safety and efficacy of this therapy, MS patients from Canada, and other jurisdictions, are traveling abroad to receive central venous angioplasty and, unfortunately, some also receive venous stents. They often return home with few instructions regarding follow-up or medical therapy. In response we propose some interim, practical recommendations for post-procedural surveillance and medical therapy, until further information is available.

Hybrid open and endovascular therapy for a proximal subclavian artery aneurysm.

A 57-year-old male presented with a large proximal right subclavian artery aneurysm that had been the source of upper extremity emboli on two occasions. A combined open and endovascular approach was undertaken involving a common carotid to vertebral artery autogenous bypass via a supraclavicular incision and endovascular repair of the aneurysm from a transbrachial approach. The patient did well postoperatively and recovered fully following a short hospitalization.

Prevention of contrast-induced nephropathy in vascular surgery patients.

Presently, only hydration and N-acetylcysteine have been shown to be effective in decreasing the incidence of radiographic contrast-induced nephropathy. We investigated the role of N-acetylcysteine and various hydration protocols in vascular surgery patients undergoing angiography. A single-center, randomized, placebo-controlled trial was conducted in patients with stable, preexisting renal dysfunction undergoing elective, outpatient angiography. Patients were randomized to outpatient oral hydration and N-acetylcysteine, inpatient hydration plus N-acetylcysteine, or our standard therapy of inpatient intravenous hydration alone. Two of twenty-eight (7%) patients who received outpatient oral hydration and N-acetylcysteine developed contrast-induced nephropathy, while two of 25 (8%) who recieved inpatient hydration plus N-acetylcysteine developed contrast-induced nephropathy and two of 25 (8%) who received standard therapy of inpatient intravenous hydration alone developed contrast-induced nephropathy. There was no statistical difference in incidence of contrast-induced nephropathy between the groups. No statistically significant independent risk factors were identified among the patients who developed contrast-induced nephropathy. N-Acetylcysteine did not confer additional benefit to patients treated with inpatient intravenous hydration. Outpatient oral hydration plus N-acetylcysteine was as effective at preventing contrast-induced nephropathy as inpatient therapies and avoided costly hospital admission.

Endovascular management of traumatic thoracic aortic injuries.

BACKGROUND: Endovascular surgery has recently been extended to the treatment of blunt traumatic aortic injuries. Since most of these injuries occur at the aortic isthmus, graft fixation in proximity to the origin of the left subclavian artery (LSA) has been a concern. Covering the LSA with graft fabric lengthens the proximal fixation site and should minimize proximal endoleaks. We therefore wished to evaluate the feasibility and safety of endovascular repair of thoracic aortic injuries after blunt trauma, both with and without deliberate coverage of the LSA. METHODS: At a tertiary care teaching hospital in London, Ont., we reviewed our experience with endovascular repair of 7 traumatic aortic injuries. We reviewed the technical success rate and the incidence of left subclavian coverage. Major morbidity, including rates of paraplegia and death were noted. The patients were followed-up with serial CT to look for endoleaks, stent migration or aneurysm growth and to determine whether they had symptoms related to left subclavian coverage. RESULTS: The time from injury to treatment ranged from 7 hours to 7 days (mean 36 h). The mean Injury Severity Score was 36. All injuries were at the aortic isthmus, and among the 7 patients treated, 6 had deliberate coverage of the LSA. One patient underwent carotid-to-subclavian artery bypass, but the other 5 did not. There were no cases of paraplegia; 1 patient had symptoms of claudication in the left arm but did not want revascularization. No procedure-related complications occurred, and all patients survived the event. Follow-up ranged from 2 to 30 (mean 13) months, and no endoleaks, stent migration or aneurysm expansion were noted in follow-up. CONCLUSIONS: Although long-term results are unknown, we conclude that endovascular repair of traumatic aortic injuries after blunt trauma can be performed safely with low morbidity and mortality and that coverage of the LSA without revascularization is tolerated by most patients.

Midterm follow-up of inflammatory abdominal aortic aneurysms following endovascular repair.

The role of endovascular therapy in the management of inflammatory aneurysms of the infrarenal abdominal aorta has been controversial. Review of our endovascular database identified six patients who have undergone treatment for preoperatively diagnosed inflammatory abdominal aortic aneurysms. Outcomes measured were primary success of the procedure, variation in computed tomographic (CT) scan-defined perianeurysmal fibrosis, change in aneurysm size, development of endoleak, requirement of reintervention, aneurysm rupture, and progression or resolution of symptoms. At a median follow-up of 20 months (range 4-56 months), endovascular repair has been successful in all six patients. All patients demonstrated CT reduction of perianeurysmal fibrosis, with a median of 47% absolute reduction (range 33-69%, p = 0.014). All patients had aneurysm sac shrinkage, with a mean of 41% (range 6-86%, p = 0.04). There were no aneurysm ruptures or persistent endoleaks. Of the three patients who presented with abdominal or back pain, all are now symptom-free. One patient required reintervention for limb thrombosis of a bifurcated graft after 2 years. In conclusion, endovascular treatment of an inflammatory abdominal aortic aneurysm is safe and effective and the treatment of choice in anatomically suitable patients.

A cost-effectiveness analysis of standard versus endovascular abdominal aortic aneurysm repair.

OBJECTIVE: To compare endovascular and standard open repair of abdominal aortic aneurysms in terms of initial in-hospital costs and the costs of secondary interventions and surveillance. DESIGN: A retrospective study. SETTING: A university-affiliated tertiary care medical centre. PATIENTS: Seven patients who underwent elective endovascular (EV) repair of an abdominal aortic aneurysm in 1998 and 31 patients anatomically suitable for endovascular repair who underwent standard (STAN) elective repair. Follow-up ranged from 2 to 14 months. INTERVENTIONS: Elective repair of an abdominal aortic aneurysm with use of the standard technique or endovascular technology. OUTCOME MEASURES: Costs common to both groups were not determined. Costs were determined for total hospital stay, preoperative or postoperative embolization, grafts, additional endovascular equipment, and follow-up computed tomography. RESULTS: Groups were similar with respect to demographic data and aneurysm size (EV = 6.23 cm v. STAN = 6.05 cm). All patients were in American Society of Anesthesiologists class III or IV. Vanguar bifurcated grafts and extensions were used in the EV group. The total cost for both groups in Canadian dollars included: cost of stay (EV, 5.6 d, $2092.63 v. STAN, 10.7 d, $4449.19; p = 0.009); cost of embolization (EV, n = 3; $900/procedure); cost of follow-up CT (EV, 5.4 per patient; $450/CT); cost of grafts (EV = $8571.43, STAN = $374); additional radiologic equipment costs (EV = $1475). The mean total cost differed significantly between the 2 groups (EV = $14,967.63 v. STAN = $4823.19; p = 0.004). The additional cost associated with a reduction in hospital stay was calculated by determining the incremental cost-effectiveness ratio (ICER, difference in mean costs/difference in mean length of stay = $1604.51). CONCLUSIONS: Endovascular repair continues to be more expensive than standard open repair determined according to procedural and follow-up costs. The technology is still in the developmental stage, but as it evolves and follow-up protocols are streamlined, it is hoped that there will be an eventual reduction in the costs associated with the endovascular procedure.

Cumulative sum failure analysis of the learning curve with endovascular abdominal aortic aneurysm repair.

PURPOSE: The purpose of this study was to evaluate the importance of experience and the learning curve with endovascular abdominal aortic aneurysm (AAA) repair. METHODS: A retrospective analysis was performed of all elective endovascular AAA repairs attempted by an individual surgeon and radiologist over a 4-year period. The primary outcome variable was achievement and 30-day maintenance of initial clinical success as defined by the Society for Vascular Surgery/American Association of Vascular Surgery reporting standards. Following standard statistical analysis, the cumulative sum (CUSUM) method was used to analyze the learning curve, with a predetermined acceptable failure rate of 10% and calculated 80% alert and 95% alarm lines. RESULTS: Ninety-six elective endovascular AAA repairs were attempted by this team between 1998 and 2002 (mean age 74 +/- 0.8 years; mean aneurysm diameter 5.98 +/- 0.8 cm). Initial clinical success was achieved and maintained in 85 of 96 patients (88.5%). Although results were acceptable throughout the study period, improved results with respect to the target failure rate (10%) were not achieved until 60 patients were treated. The learning or CUSUM curves did not differ for different device manufacturers, with improved results being achieved following 20 implantations of each device. The results did differ when comparing aortouniiliac grafts (n = 27) and bifurcated grafts (n = 64). Results with bifurcated grafts remained consistent throughout the study period, whereas with aortouniiliac grafts, results improved after only a few procedures in comparison with the target failure rate. CONCLUSION: Success rates with endovascular aneurysm repair will improve with an individual's experience. The CUSUM method is a valuable tool in the evaluation of this learning curve, which has credentialing and training implications. Although acceptable results were obtained throughout the study period, this analysis indicates that 60 endovascular aneurysm repairs, or 20 with an individual device, are necessary before optimal rates of initial clinical success can be achieved. These results can be achieved more readily with aortouniiliac grafts than with bifurcated grafts.

Implementation of a successful endovascular surgical program in a non-teaching tertiary-care centre in Ontario.

Endovascular surgical techniques have become an accepted standard of care for high-risk patients with abdominal aortic aneurysms and for certain patients with thoracic aortic pathology and peripheral arterial aneurysms. In Canada, endovascular surgery has been concentrated in tertiary-care academic teaching institutions. As the technology evolves and as expertise advances, the applicability of endovascular techniques will expand. With time, and as the demand for endovascular techniques rises, this expertise will increasingly need to be delivered by dedicated vascular surgical services in nonteaching institutions. The dissemination of endovascular surgical capabilities represent a unique challenge. We report the successful implementation of an endovascular surgical program in a tertiary-care nonteaching institution using a carefully planned preceptorship model. We review our initial 49 cases and discuss 6 factors important to the successful establishment of an endovascular surgical service: education, teamwork, strict selection of patients, use of a single stent-graft manufacturer, industry support and endovascular preceptorship. Our experience may be used as a model by other institutions in Canada.

Regular monitoring of access flow compared with monitoring of venous pressure fails to improve graft survival.

Regular vascular access blood flow (Qa) surveillance is recommended to detect graft stenosis; however, there is little evidence that monitoring and correcting with angioplasty improves graft survival. This blinded, randomized, controlled trial of 112 patients studied time to graft thrombosis and graft loss, comparing monthly Qa plus standard surveillance (dynamic venous pressure and physical examination) (treatment group) to standard surveillance alone (control group). Only the treatment group was referred for angiogram if Qa <650 ml/min or a 20% decrease in Qa from baseline. Percutaneous angioplasty was performed for stenosis >50%. The rate of graft thrombosis per patient-year at risk was 0.41 and 0.51 in the control and treatment groups, respectively. Fifty-one interventions (0.93/patient-years at risk) were performed in the treatment group versus 31 interventions (0.61/patient-years at risk) in the control group. There was no difference in time to graft loss (P = 0.890). In a multivariate analysis, aspirin (ASA) therapy at baseline was associated with an 84% reduction in risk of graft thrombosis (odds ratio [OR], 0.14; P = 0.002). Higher baseline Qa (OR, 0.84; P = 0.05) and longer interval since graft insertion (OR, 0.97; P = 0.07) were associated with a decrease in graft thrombosis. Results reveal that graft surveillance that uses Qa increases the detection of stenosis, compared with standard surveillance; however, intervention with angioplasty does not improve the time to graft thrombosis or time to graft loss.