Safety and efficacy of the Mynx Control vascular closure device in peripheral arterial procedures: A prospective study.

OBJECTIVES: This article aims to present a prospective study investigating the safety and efficacy of the Mynx Control extravascular closure device (Cordis Corporation, FL, USA), for femoral arterial closure in patients undergoing peripheral arterial procedures. METHODS: Between January 2020 and February 2021, 100 Mynx Control devices were deployed in 91 consecutive patients (mean age: 67.5 ± 16.9 years) who underwent peripheral arterial procedures. We used ultrasound and/or fluoroscopy during Mynx Control deployment and ultrasound post-procedure to detect complications. Femoral artery punctures included 62 (62%) antegrade and 38 (38%) retrograde punctures. The mean activated clotting time at time of device deployment was 221s. The primary endpoints were technical success, device failure, and complication rates up to 30 days. RESULTS: A 5F vascular sheath was used in 43 cases (43%) (36 (36%) 6F and 21 (21%) 7F). The majority of our cases had antegrade access (62%). Overall technical success rate was 97% in both antegrade and retrograde cases. In total, there were 4 minor complications: 3 (3%) cases of pseudoaneurysm and 1 (1%) case of haematoma. No major complications were recorded post-procedure or 30 days post index procedure. CONCLUSION: The Mynx Control vascular closure device is safe and effective in achieving haemostasis in patients undergoing antegrade and retrograde peripheral angioplasty procedures.

Fluoroscopic-guided insertion of self-expanding metal stents for malignant gastroduodenal outlet obstruction: immediate results and clinical outcomes.

BACKGROUND: Application of self-expanding metal stents (SEMS) to treat patients suffering from malignant gastroduodenal outlet obstruction (GDOO) is today considered a well-recognized palliative treatment. Use of SEMS has emerged as an attractive alternative to surgical treatment of such patients. PURPOSE: To report the immediate and the mid-term clinical outcomes from a series of consecutive patients treated with exclusively fluoroscopic-guided insertion of SEMS. MATERIAL AND METHODS: This was a retrospective study including patients suffering from GDOO that were either ineligible for or unwilling to undergo surgery. Patients with potentially curable disease, uncorrectable coagulopathy, gastrointestinal perforation, sepsis, presence of distal small bowel obstruction, and bowel ischemia were excluded. Technical success, clinical success, and major complications were calculated. In addition, stent migration, stent re-obstruction, restenosis, and overall re-interventions due to recurrent symptoms were considered. Kaplan-Meier survival analysis was used for patient survival estimation while both bivariable and multivariable analysis were performed to identify any independent predictors of outcomes. RESULTS: Fifty-one patients, (mean age, 63.73 ± 15.62 years) met the study's criteria and were included in the final analysis. Technical and clinical success were 90.19% (n = 46/51) and 91.30% (n = 42/46), respectively. Major complications rate was 3.92%. Stent migration was noted in four cases. Restenosis and re-obstruction rates were 19.57% and 10.87%, respectively. No cases of peri-procedural mortality were noted, while Kaplan-Meier estimates for 1- and 2-year survival were 16.8% and 7.2%, respectively. Clinically successful cases and patients with primary GI tumor were related with more favorable survival compared to unsuccessful and patients suffering from GDOO due to extrinsic compression by neoplastic or lymph node disease. CONCLUSION: Exclusively fluoroscopically inserted SEMS for GDOO is safe and highly effective method for palliative treatment.

Bayesian network meta-analysis of nitinol stents, covered stents, drug-eluting stents, and drug-coated balloons in the femoropopliteal artery.

OBJECTIVE: Several randomized controlled trials (RCTs) have shown the superiority of some of these technologies over balloon angioplasty, but direct comparisons between these treatment options are lacking. The authors conducted a network meta-analysis of RCTs comparing bare nitinol stents, covered nitinol stents, paclitaxel- or sirolimus-eluting stents (PES or SES), and paclitaxel-coated balloons (PCB) with plain balloon angioplasty or with each other in the femoropopliteal artery (PROSPERO registry: CRD42013004845). METHODS: Sixteen RCTs comprising 2532 patients with 4227 person-years of follow-up were analyzed on an intention-to-treat basis. Bayesian random effects Poisson and binomial models were used for mixed treatment comparisons (WinBUGS). Clinical heterogeneity was accounted for by incorporating a meta-regression model on trial-specific baseline risk. End points included technical success, vascular restenosis, target lesion revascularization, and major amputations. Pairwise odds ratios and rate ratios (ORs and RRs) of absolute treatment effects were calculated, and the probabilities of each treatment being best are reported. Summary estimates are reported as the posterior median and associated credible intervals (CrIs) that serve the same purpose as confidence intervals in the context of the Bayesian framework. Extensive sensitivity, meta-regression, and network consistency analyses were performed to evaluate heterogeneity. RESULTS: Technical success was highest with covered stents (pooled OR, 13.6; 95% CrI, 3.3-31.1, probability best 82%) followed by uncovered stents (pooled OR, 7.0; 95% CrI, 2.6-129, probability best 18%) when compared with balloon angioplasty (reference treatment). Vascular restenosis was lowest with PES (RR, 0.43; 95% CrI, 0.16-1.18, probability best 45%) followed by PCB (RR, 0.43; 95% CrI, 0.26-0.67, probability best 42%). Target lesion revascularization was lowest with PCB (RR, 0.36; 95% CrI, 0.23-0.55, probability best 56%) followed by PES (RR, 0.42; 95% CrI, 0.16-1.06, probability best 33%). Major amputations were rare in all treatment and control groups (pooled amputation rate of 0.7 events per 100 person-years). CONCLUSIONS: Immediate technical success is better with the use of covered stents, whereas paclitaxel-eluting stents and paclitaxel-coated balloons offer the best long-term results in the femoropopliteal artery.

Percutaneous radiofrequency ablation of small renal tumours in patients with a single functioning kidney: long-term results.

OBJECTIVES: To evaluate the long-term results of percutaneous radiofrequency ablation (RFA) of small renal tumours in patients with a single functioning kidney (SFK). METHODS: This is a single-centre prospective study. Patients with an SFK and a tumour smaller than 3.5 cm, treated with RFA over a 7.5-year period, were included. Nineteen consecutive patients (12 male), aged between 33 and 83 years (mean 61.4), were treated for 23 lesions. Primary endpoints were technical success and tumour recurrence rate. Secondary endpoints were the deterioration of renal function and overall survival rate. RESULTS: The mean follow-up was 56.1 months (range 36-102). Primary technical success was 100 %. There were no major peri-procedural complications. In two cases, minor complications occurred. There was no significant difference between the baseline glomerular filtration rate (GFR) and GFR at 3, 12 and 24 months post-procedure. In four lesions (17 %), recurrence was detected and an additional RFA session was performed. None of the patients developed renal failure during their lifetime. Three of the patients died because of other reasons. CONCLUSIONS: Percutaneous RFA of small renal tumours in patients with an SFK offers very satisfactory long-term results regarding preservation of renal function, local tumour control and overall survival. KEY POINTS: • Tumour in a single functioning kidney requires minimally invasive treatment. • Radiofrequency ablation plays an established role in managing small renal tumours. • Long-term results of radiofrequency ablation have shown satisfactory local tumour control. • Long-term results have also shown that renal function may be preserved.

CIRSE Standards of Practice on Oesophageal and Gastroduodenal Stenting.

BACKGROUND: Image-guided insertion of stents in the upper gastrointestinal trunk is an effective, minimally invasive treatment option to provide immediate relief of symptoms caused by upper gastrointestinal tract obstruction related to advanced-stage malignant causes or benign causes that lead to lumen narrowing. PURPOSE: This document, as with all CIRSE Standards of Practice documents, is not intended to impose a standard of clinical patient care but will recommend a reasonable approach to best practices for performing stenting of the upper gastrointestinal tract, namely the oesophageal and gastroduodenal segments. Our purpose is to provide up-to-date recommendations for placement of upper gastrointestinal tract stents based on the previously published guidelines on this topic in 2005 and 2007. METHODS: The writing group was established by the CIRSE Standards of Practice Committee and consisted of a group of internationally recognised experts in performing upper gastrointestinal stenting. The writing group reviewed the existing literature using PubMed to search for relevant publications in the English language up to September 2021. The final recommendations were formulated through consensus. CONCLUSION: Insertion of stents in the oesophageal and gastroduodenal tracts has an established role in the successful management of malignant or benign obstructions. This Standards of Practice document provides up-to-date recommendations for the safe performance of upper gastrointestinal stent placement.

Fluoroscopically guided dilation of esophageal strictures in patients with dystrophic epidermolysis bullosa: long-term results.

OBJECTIVE: The purpose of this study was to investigate the immediate and long-term outcomes after fluoroscopically guided balloon dilation of esophageal strictures in a series of patients with dystrophic epidermolysis bullosa (DEB). MATERIALS AND METHODS: Between 2005 and 2011, the medical records of all patients with DEB treated with fluoroscopically guided balloon dilation of esophageal strictures were included in the study and retrospectively analyzed. The indication for treatment was dysphagia attributed to at least one radiologically verified esophageal stricture. The primary endpoints of the study included procedural technical success, clinical improvement assessed with a 0-4 dysphagia score, and major complication rate. Secondary endpoints were patient survival and reintervention rates. RESULTS: Nineteen consecutively registered patients with DEB (age range, 10-51 years; mean, 30 ± 12.2 years) and dysphagia due to esophageal strictures were treated with fluoroscopically guided balloon dilation. In total, 90 procedures and 121 dilations were performed to manage 28 lesions. Balloon diameter ranged from 8 to 18 mm. The mean follow-up time was 47.51 ± 16.64 months (range, 17-73 months). The technical success rate was 96.7% (87/90). There were no major complications. The mean reintervention rate was 1.19 dilations per patient per year, and the postprocedural dysphagia score (0.72 [95% CI, 0.56-0.87]) was significantly lower than baseline (2.50 [95% CI 2.35-2.65]) (p < 0.001). CONCLUSION: Repeated fluoroscopically guided balloon dilation is safe and effective for the management of dysphagia caused by esophageal strictures in DEB. Use of this technique was associated with marked clinical improvement in dysphagia and satisfactory long-term reintervention rates with no major complications.

Percutaneous closure and "push-pull" technique to repair arterial lead and sheath placement complicating cardiac resynchronization therapy.

We present a case of inadvertent subclavian arterial puncture and lead placement to the left ventricle in a patient undergoing cardiac resynchronization therapy. We describe the use of a "push-pull" technique within an arterial setting to allow removal of the lead, while maintaining access through the same puncture to allow an arterial-closure device to then seal the artery at this site. As a result of this percutaneous approach, the patient avoided the need for a vascular surgical procedure.

Successful exclusion of a large bronchopleural fistula using an Amplatzer II vascular plug and glue embolization.

We report a case of a 63-year-old man with a complicated postsurgical bronchopleural fistula (BPF), which was treated with a minimally-invasive hybrid procedure using fluoroscopy, bronchoscopy, and thoracoscopy. A previous surgical attempt had failed to seal the pathologic tract. An Amplazter II vascular plug was successfully deployed into the BPF, followed by autologous blood and glue injection. An adjunctive endoscopically-guided glue embolization was deemed necessary. The 14-month clinical and imaging follow-up confirmed the successful exclusion of the BPF. No migration of the device was noted and the patient remained asymptomatic. The combined endoscopic and fluoroscopic guided management of a BPF using the Amplatzer II vascular plug and glue was proven safe and effective after mid-term follow-up.

Pre-Operative Embolisation of an Aberrant Pharyngeal Arterial Branch Arising From the Internal Carotid Artery and Contributing Significantly to the Supply of a Large Juvenile Nasopharyngeal Angiofibroma.

Preoperative embolisation of juvenile nasopharyngeal angiofibromas (JNAs) is a well-established treatment that reduces intraoperative blood loss and improves surgical outcomes. While the bulk of arterial supply to the tumour is derived from the external carotid system, some degree of contribution from the internal carotid artery (ICA) is common. ICA branch embolisation in this setting has previously been avoided due to concerns over ischaemic neurological complications, possibly contributing to the increased intraoperative blood loss observed in patients with tumours with ICA supply. There is a marked paucity of reports of embolisation of ICA branches supplying JNA in the medical literature. We present a case of successful embolisation of an aberrant pharyngeal branch of the ascending pharyngeal artery arising from the proximal cervical ICA, which was making a significant contribution to tumour blood supply in a male adolescent with a very large JNA.

Transcatheter Embolization of the Inferior Epigastric Artery: Technique and Clinical Outcomes.

PURPOSE: Symptomatic rectus muscle sheath hematoma may be the result of bleeding originating from the inferior epigastric artery. We report the technique and the results from a series of consecutive patients treated by transcatheter embolization, evaluating both ipsilateral and contralateral retrograde approaches. METHODS: This was a retrospective study including patients with verified rectus muscle sheath hematoma as a result of active extravasation from the inferior epigastric artery referred for transcatheter embolization. Technical success, clinical success and major complications were calculated. In addition, minor complications, blood transfusions required after a technically successful embolization, length of stay, peri-procedural and 30-day mortality and overall survival at 6 months were obtained. All statistical analysis was performed using SPSS. RESULTS: Twenty-one patients (mean age = 59.67 ± 19.51 years old) were included. The cause of the bleeding in the vast majority was iatrogenic trauma (n = 12/21, 57.14%). Both contralateral (n = 12/21, 57.14%%) and ipsilateral (n = 9/21, 42.86%) retrograde approaches were used. Embolic materials included micro-coils (n = 13/20, 65%), microspheres (PVA) (n = 1/20, 5%), a combination of PVA and micro-coils (n = 5/20, 25%) and gel-foam (n = 1/20, 5%). Overall technical success was 95.2% (n = 20/21) while clinical success was achieved in all but one of the technically successful cases 95% (n = 19/20). One patient died peri-procedurally due to profound hemodynamic shock. There were no other major complications. Additional transfusion was necessary in 7 patients (n = 7/21, 33.33%). There was a significant increase in the hemoglobin levels after the embolization (7.03 ± 1.78 g/dL pre-procedure Vs 10.91 ± 1.7 g/dL post-procedure, p = 0.048). The median hospital stay was 8 days. The peri-procedure and 30-day mortality was 4.8% (n = 1/21) and 28.6% (n = 6/21) respectively. The 6-month survival was 61.9% (13/21). CONCLUSION: Percutaneous embolization of the inferior epigastric artery is a minimally invasive method with satisfactory results. Both ipsilateral and contralateral retrograde approaches are feasible.

Long-term anticoagulation in Kawasaki disease: Initial use of low molecular weight heparin is a viable option for patients with severe coronary artery abnormalities.

Patients with severe coronary artery involvement after Kawasaki disease (KD) require long-term systemic anticoagulation. We sought to compare our experience with thrombotic coronary artery occlusions, safety profile, and degree of coronary artery aneurysm regression in KD patients treated with low molecular weight heparin (LMWH) versus warfarin. Medical records of all KD patients diagnosed between January 1990 and April 2007 were reviewed. Of 1374 KD patients, 38 (3%) received systemic anticoagulation, 25 patients received LMWH from diagnosis onward, 12 of whom were subsequently switched to warfarin, and 13 received warfarin from onset. The frequency of thrombotic coronary artery occlusions was similar between drugs. Severe bleeding was more frequent in patients on warfarin, but minor bleeding was more frequent for patients on LMWH. Patients on warfarin were at greater risk of underanticoagulation or overanticoagulation (defined as achieving an anti-activated factor X level or an international normalized ratio below or above target level) than patients on LMWH (P < 0.05). Maximum coronary artery aneurysm z-scores diminished with time for patients on LMWH (P = 0.03) but not for those on warfarin (P = 0.55). This study suggests that LMWH is a potentially viable alternative for patients, especially young ones, with severe coronary artery involvement after KD.

Percutaneous cementoplasty.

Cementoplasty includes percutaneous procedures like vertebroplasty, kyphoplasty, osteoplasty, and sacroplasty. Bone packing with cement aims to treat or prevent vertebral and extraspinal pathological fractures and relieve pain in patients with osteoporosis and bone metastases. The authors outline the accepted and newer indications for patient selection and present the fundamentals of image-guided lesion access and cement injection. Practitioners should evaluate each patient carefully and have a thorough knowledge of the anatomy, the technique, the expected outcomes, and the potential complications. Detailed informed consent and multidisciplinary decision making are recommended. Understanding of the particular advantages and limitations of the various modern filler materials is also crucial for a successful and uncomplicated procedure. Future developments include new mechanical devices for effective restoration of vertebral height, as well as the introduction of osteoconductive and osteoinductive cements that will be able to promote more physiological bone healing.

Audit of electronic operative documentation in interventional radiology: the value of standardised proformas.

BACKGROUND: On the background of the interventional radiology department of a tertiary hospital converting its periprocedural documentation from paper-based to electronic using a standardised proforma, a study was performed to ascertain the effects of this change on the standard of clinical documentation for radiologically-guided angiographic procedures. Using a retrospective approach, perioperative records were analysed in reverse chronological order for inclusion in the study. The standard for this audit was developed in the form of minimum criteria that all clinical documentation of angiographic procedures were expected to meet. RESULTS: The audit was performed at three equally spaced intervals of 6 months, yielding a total of 99 records. The baseline audit of paper-based records concluded > 80% completeness for 8 out of the 14 of parameters measured, with only two of parameters meeting the target of 100% completeness. The second audit cycle performed on electronic records found 7 out of 14 parameters demonstrating absolute improvement in completeness, when compared to paper-based, but with the number of parameters exceeding 80% completeness falling to only 4 out of 14. Again, 100% completeness was observed in only 2 of the parameters. In the final audit cycle, after the introduction of a standardised electronic proforma, performance improved in every dimension with 6 out of 14 parameters reaching completeness of 100% and the 80% completeness threshold met by 12 out of 14 parameters. CONCLUSION: The construction of a procedure-specific perioperative electronic proforma can save clinicians valuable time and encourage safe and effective clinical documentation.

Arterial complications associated with cardiac catheterization in pediatric patients with a previous history of Kawasaki disease.

OBJECTIVES: To determine whether patients with Kawasaki Disease (KD) undergoing percutaneous catheter angiography were at increased risk of arterial complications at the point of arterial access compared to patients with structural heart abnormalities, but normal vessels. BACKGROUND: Systemic arterial damage can occur as a result of KD. METHODS: Medical histories of all patients with KD undergoing percutaneous catheter angiography at The Hospital for Sick Children between January 1990 and August 2008 were reviewed. RESULTS: A total of 44 patients with KD underwent 82 catheter procedures. Of these, 3 were associated with important arterial complications (2 males; age: 4 months, 3 and 17 years). All patients who experienced complications had multiple large and/or giant coronary artery aneurysms and two were within 3 months of the acute phase of KD. All patients developed pseudoaneurysms of the femoral artery which had been utilized for catheter access. All pseudoaneurysms were treated with ultrasound-guided thrombin injection and compression, and resolved with no long-term complications. One patient also developed a substantial arteriovenous fistula of the femoral circulation which had to be surgically repaired with no permanent sequela. Odds for arterial complications in patients with KD were 10.4 times greater (95%CI: 3.2-33.8) than that noted for the general pediatric cardiac catheterization population (3.6% vs. 0.4%, P < 0.0001) which indicates higher risk associated with arterial access in patients with KD. CONCLUSIONS: Greater care in obtaining arterial access for angiography is warranted, especially in the first month directly following the acute phase, possibly related to systemic arterial damage associated with KD.

Direct erosion and prolapse of esophageal stents into the tracheobronchial tree leading to life-threatening airway compromise.

Covered or uncovered self-expanding metal stents are currently used for the palliative treatment of neoplastic esophageal obstructions or compressions and malignant esophageal leaks or fistulas. This small series, from three different European hospitals, highlights the unusual but significant complication of esophageal stent perforation followed by erosion and prolapse of the endoprosthesis into the tracheobronchial tree causing acute airway compromise or aspiration. Possible causal mechanisms and means of treatment are discussed to raise physician awareness of this life-threatening complication.

Image-guided ablation therapy of bone tumors.

A wide range of thermal and cryoablation methods is currently available for the curative eradication or palliative treatment of a variety of bone and soft-tissue tumors. Radiofrequency ablation has been developed as a multipurpose tool for the skeletal system. Cryoablation has the added advantages of direct computed tomography or magnetic resonance visualization and monitoring of treatment outcome with less peri- and postoperative pain. Use of appropriate thermo-sensors and insulation techniques, like carbon dioxide insufflation, results in enhanced safety and efficacy. Ablation of weight-bearing bones has to be supplemented with cement consolidation. The authors present an overview of the current status of percutaneous image-guided ablation therapy of bone and soft-tissue tumors, analyze the merits and limitations of the various systems available, and discuss possible new applications for the future.