Primary 3-Month Outcomes of a Double-Blind Randomized Prospective Study (The QUEST Study) Assessing Effectiveness and Safety of Novel High-Frequency Electric Nerve Block System for Treatment of Post-Amputation Pain.

Purpose: This multicenter, randomized, double-blinded, active sham-controlled pivotal study was designed to assess the efficacy and safety of high-frequency nerve block treatment for chronic post-amputation and phantom limb pain. Patients and Methods: QUEST enrolled 180 unilateral lower-limb amputees with severe post-amputation pain, 170 of whom were implanted with the Altius device, were randomized 1:1 to active-sham or treatment groups and reached the primary endpoint. Responders were those subjects who received ≥50% pain relief 30 min after treatment in ≥50% of their self-initiated treatment sessions within the 3-month randomized period. Differences between the active treatment and sham control groups as well as numerous secondary outcomes were determined. Results: At 30-min, (primary outcome), 24.7% of the treatment group were responders compared to 7.1% of the control group (p=0.002). At 120-minutes following treatment, responder rates were 46.8% in the Treatment group and 22.2% in the Control group (p=0.001). Improvement in Brief Pain Inventory interference score of 2.3 ± 0.29 was significantly greater in treatment group than the 1.3 ± 0.26-point change in the Control group (p = 0.01). Opioid usage, although not significantly different, trended towards a greater reduction in the treatment group than in the control group. The incidence of adverse events did not differ significantly between the treatment and control groups. Conclusion: The primary outcomes of the study were met, and the majority of Treatment patients experienced a substantial improvement in PAP (regardless of meeting the study definition of a responder). The significant in PAP was associated with significantly improved QOL metrics, and a trend towards reduced opioid utilization compared to Control. These data indicate that Altius treatment represents a significant therapeutic advancement for lower-limb amputees suffering from chronic PAP.

Contemporary Review of Traumatic Axillary and Subclavian Artery Injuries at an Urban Level One Trauma Center.

OBJECTIVE: Traumatic axillary and subclavian artery injuries are uncommon. Limited data are available regarding patient and injury characteristics, as well as management strategies and outcomes. METHODS: Retrospective chart review was performed on patients presenting to University of Louisville Hospital, an urban Level One Trauma Center, with traumatic axillary and subclavian artery injuries from 2015-2021. Patients were identified using University of Louisville trauma, radiology, and billing database searches based on ICD9/10 codes for axillary and subclavian artery injuries. Descriptive statistics are expressed as frequencies and percentages. Comparisons were performed using Fisher's Exact and Chi-squared tests. RESULTS: Forty-four patients with traumatic axillary-subclavian arterial injuries were identified for analysis. Blunt and penetrating trauma were equally represented (n = 22 for both). A variety of injury types were seen, including minimal/intimal injury, laceration, pseudoaneurysm, transection, occlusion, and arteriovenous fistula. Management strategies were also variable, including non-operative, endovascular, planned hybrid, open, and endovascular converted to open. In operative patients, revascularization technical success was high (n = 31, 97%) with low likelihood of thrombosis (n = 2, 6%) and no infections. Among all patients, amputation rate was 5% (n = 2) and mortality rate was 9% (n = 3). Regarding arterial involvement, blunt injury was more likely to affect the subclavian (n = 18) than the axillary artery (n = 6) (P = .04). No significant difference was seen in brachial plexus injury based on artery involved (subclavian = 9 vs axillary = 11, P = .14) or mechanism (blunt = 6 vs penetrating = 11, P = .22). Non-operative management was more likely with subclavian artery injury (n = 11) vs axillary artery injury (n = 1) (P = .008). There was no significant difference between decision for non-operative (blunt = 9, penetrating = 3) vs operative (blunt = 13, penetrating = 19) management based on mechanism (P = .09). Transection injury was associated with an open repair strategy (endovascular/hybrid = 1, open/endovascular to open conversion = 11, P = .0003). Of the three patients requiring endovascular to open conversion, two required amputation, which were the only two patients in the study undergoing amputation. CONCLUSIONS: Both open and endovascular/hybrid strategies are useful when treating traumatic axillary and subclavian artery injuries and are associated with high likelihood of revascularization technical success, with low rates of thrombosis or infection, when treated promptly at a trauma center with vascular specialists available. Transection injuries were most often treated with open revascularization. Patients undergoing amputation had blunt transection injuries to the subclavian artery and underwent endovascular to open conversion after failed attempts at endovascular revascularization.

Endovascular Management of A Symptomatic Giant Hepatic Artery Aneurysm.

Hepatic artery aneurysms (HAAs) are an uncommon clinical condition. Ruptured hepatic artery aneurysm carries a high incidence of mortality. Traditionally, they are treated with open surgical resection; however, endovascular aneurysm exclusion is an alternative option to open repair in select patients who have suitable anatomy. Here, we present a case of a giant hepatic artery aneurysm treated with a covered stent placement.

Endovascular Repair of Traumatic Infrarenal Aortic Injury in an 8-Year-Old.

The patient is an 8 year-old male presenting to outside facility following high-speed motor vehicle collision in which he was a restrained passenger. CT imaging at that time demonstrated a traumatic infrarenal aortic pseudoaneurysm, extensive pneumoperitoneum and free fluid, and an unstable L2 vertebral body fracture. He underwent exploratory laparotomy with small bowel resection prior to transfer. The patient was left in discontinuity and temporary closed. Vascular surgery was consulted upon arrival to tertiary care children's hospital. The decision was made to proceed with emergent endovascular repair. An aortogram confirmed the location of the aortic disruption well below the renal arteries, superior to the bifurcation. An 11 mm × 5 cm Viabahn covered stent was placed across the injury with adequate proximal and distal seal. This is a case of seatbelt-related pediatric infrarenal aortic injury in the setting of polytrauma. Endovascular repair was pursued in this damage-control setting.

Comparing Patency Rates of Arteriovenous Dialysis Access following Percutaneous Thrombectomy Using Various Catheter Directed Therapies.

BACKGROUND: Arteriovenous fistulas often require frequent interventions to maintain patency for hemodialysis. Interventions may include open or percutaneous thrombectomy with additional targeted interventions as indicated. We evaluated the primary and cumulative functional patency rates following three unique approaches to percutaneous thrombectomy of thrombosed dialysis access. METHODS: A retrospective review of 236 unique patients who presented with thrombosed hemodialysis access was analyzed over a period of 4 years from 2016 to 2020. We analyzed a total of 413 procedures that utilized 3 separate percutaneous thrombectomy devices to assist with restoring patency. The Indigo System CAT-D Aspiration Thrombectomy Catheter (Penumbra; Alameda, CA), the Arrow-Trerotola Rotational Thrombectomy System (Teleflex; Wayne, PA) and the Angiojet Rheolytic Thrombectomy Catheter (Boston Scientific, Marlborough, MA) devices were compared for primary and cumulative functional patency. Primary patency was defined as time from percutaneous thrombectomy to next intervention (Angioplasty, stenting, and repeat thrombectomy). Cumulative functional patency was defined as time from percutaneous thrombectomy to time of access abandonment. Medical record chart review was utilized to determine patency rates. RESULTS: A total of 413 percutaneous thrombectomy procedures were performed. Of the procedures performed, 98 utilized Angiojet, 103 utilized Trerotola, and 212 used Penumbra. The mean primary patency rates in (days) for the devices were as follows: Angiojet (194), Trerotola (204), and Penumbra (107). The mean cumulative functional patency rates (in days) for the devices were as follows: rheolytic thrombectomy (450 days), aspiration thrombectomy (292 days), and rotational thrombectomy (475 days). Angiojet versus Penumbra and Trerotola versus Penumbra both showed diminished patency rates when using the Penumbra catheter that were statistically significant (P < 0.05). CONCLUSIONS: All percutaneous thrombectomy approaches do not result in the same primary or cumulative functional patency rates. Approaches with Trerotola and Angiojet resulted in improved primary and cumulative functional patency rates compared to those using Penumbra.

Endovascular Treatment of Innominate Artery Bifurcation Injury with Balloon-Expandable Covered Stents Utilizing Kissing Stent Technique.

Major injury of the innominate artery is traditionally treated with an open repair which is technically challenging, associated with large volumes of blood loss and prolonged operative times. Endovascular treatment with covered stent placement across the injury is an attractive alternative. However, placement of a single covered stent across the innominate artery bifurcation into one of its distal branches will not prevent bleeding because of retrograde perfusion from the unstented branch distal to the bifurcation. Here, we report a case of successful endovascular repair of one such injury involving the innominate artery bifurcation with ongoing extravasation into the mediastinum. The injury was successfully treated by utilizing 2 balloon-expandable covered stents placed in kissing fashion from the innominate artery into both of its distal branches. This technique of parallel covered stent placement across a bifurcation could effectively repair bifurcation injuries while maintaining patency of both distal branches.

Inferior vena cava perforation during percutaneous filter removal.

BACKGROUND: Percutaneous Inferior Venacava (IVC) filter retrieval can be challenging when the filter is grossly angulated, embedded in the wall or penetrates through the IVC. When conventional filter removal technique fails, the use of advanced retrieval techniques often improves the chances of percutaneous filter retrieval. These techniques, however, are associated with a high rate of complications. METHODS: We report a case of 26-year-old female who had IVC filter placed on postpartum day 4. Attempted percutaneous filter retrieval 3 weeks later with loop snare technique and endobronchial forceps assisted filter removal technique resulted in gross filter deformity, malposition, and IVC perforation. RESULT: Open IVC filter removal was performed with midline laparotomy and cavotomy with lateral venorrhapy. The deformed filter along with adherent thrombus was completely removed. The patient had an uneventful recovery with no immediate or long-term complications. CONCLUSION: Use of advanced endovascular IVC filter retrieval techniques could result in serious complications like filter fracture, migration and IVC perforation. Since excessive tilt of the filter at the time of placement often results in difficult retrieval, it is important to ensure proper deployment of the filter with minimal tilt. If encountered with excessively tilted or embedded filter, one should refrain from excessive manipulation of the filter and consider open filter removal.

A Large True Brachial Artery Aneurysm in an Infant.

A 6-month-old male was admitted to the children's hospital for management of an underlying gastrointestinal illness. During his admission, a large, pulsatile mass was incidentally noted in the left upper arm concerning for an expanding pseudoaneurysm. Vascular surgery was consulted, and further workup with a CT angiogram demonstrated a brachial artery aneurysm 3 cm in greatest diameter. The patient was taken to the operating room, where lateral aneurysmorraphy was performed without complication. His neurovascular exam remained intact postoperatively. The presented case demonstrates a viable approach to the surgical management of this clinical challenge in infants. Although reports of brachial artery aneurysm in this age group are rare in the literature, resection with primary repair and interposition grafting have also been described. Long-term outcomes are not available in these cases. Lateral aneurysmorraphy allows for ongoing monitoring and future resection and bypass of the aneurysm as the patient continues to grow.

Endovascular Repair of Transected Axillary Artery via Snare Assisted Through and Through Femoral to Brachial Artery Access.

Axillary artery injury is a rare but complex surgical problem that often requires challenging exposures, lengthy operations, and morbid outcomes for repair. For these reasons, endovascular repair is an attractive alternative as it obviates many of the challenges present with open repair. While pseudoaneurysms, dissections, and short segment injuries with limited arterial disruption are regularly treated endovascularly, complete arterial transections are almost exclusively treated with open repair as obtaining wire access across the site of injury is often not possible. Here we report a case of successful endovascular repair of a completely transected axillary artery with the use of snare assistance to obtain through and through femoral to brachial artery access. This ultimately allowed for covered stent deployment across the axillary transection restoring distal blood flow. Snare assistance in obtaining through and through access across areas of complete transection can allow for increased use of endovascular repair.

Vagal Nerve Stimulator Placement by a Vascular Surgeon.

BACKGROUND: Refractory seizure activity represents a difficult problem for both patients and practitioners. Implantation of the vagal nerve stimulator has been posited as an effective treatment for refractory seizure activity. These devices are inserted by placing leads into the carotid sheath along the vagus nerve. We evaluated a vascular surgeon's experience placing vagal nerve stimulators. METHODS: We examined all patients treated with placement of vagal nerve stimulator by a single surgeon from October 2016 to October 2018. Data collected included demographics, medical and surgical history, intraoperative variables, and complications. RESULTS: Thirty-four patients underwent placement of a vagal nerve stimulator. About 29.4% had a previous vagal nerve stimulator placed on the ipsilateral side. Intraoperative bradycardia was seen in 1 patient. Postoperative complications were identified in 5 patients, all of which were transient dysphagia or changes in voice quality which did not require intervention. There was no significant difference between patients with the previous operation and those without for developing postoperative complications (P = .138). Average blood loss was higher in patients who had undergone previous stimulator placement than those who had not (P = .0223), and the operative time was longer (P ≤ .0001). DISCUSSION: Given the anatomical location of placement, vascular surgeons may be called upon to place these devices. In our single surgeon series, we found that the placement was safe, with minimal complications. Intraoperatively, this case appears to be more difficult (with higher blood loss and longer operative time) in patients who have had previous device placement, but this does not appear to lead to increased complications.

Use of Indocyanine Green During Repair of a Superior Mesenteric Artery Aneurysm.

Superior mesenteric artery (SMA) aneurysms are rare and associated with a high risk of rupture, with resultant significant morbidity and mortality. During open operative repair of a superior mesenteric artery aneurysm, perfusion of the involved small bowel must be evaluated when determining need for and/or extent of vascular reconstruction. We present a case of a 51-year-old woman who underwent open repair of a non-ruptured superior mesenteric artery aneurysm with ligation and excision, in whom no revascularization was determined to be needed and the involved small bowel was able to be preserved, with intraoperative evaluation of perfusion using indocyanine green (ICG) fluorescence imaging, as an adjunct to more traditional methods of perfusion assessment.

Endovascular Treatment of Giant Celiac Artery Aneurysm in Behcet's Disease.

We report a case of a 17-year-old male with Behcet's disease (BD) with giant celiac artery aneurysm and impending rupture. Over the past 8 weeks, patient began having intermittent back and abdominal pain that worsened and became persistent over the past few days. This was accompanied by anorexia and non-bilious vomiting. Computed tomography angiogram (CTA) demonstrated a wide neck large celiac artery aneurysm (60 mm diameter). Endovascular repair of the aneurysm was performed using stent graft of the aorta and transcatheter coil embolization of the aneurysm sac. Technical success was confirmed by interruption of flow in the aneurysm, and preservation of distal native circulation at the conclusion of the procedure. One-week post-embolization, a CTA demonstrated complete thrombosis of the aneurysm. On follow-up CTA at 3, 6, and 12 months after embolization, the aneurysm has completely thrombosed and decreased in size to 24 mm. Patient remains asymptomatic till date.

Endovascular Rescue of Sheath Perforation During Inferior Vena Cava Filter Retrieval.

INTRODUCTION: Inferior vena cava (IVC) filter retrieval is generally a straightforward procedure but can be challenging with unique complications. A technique used for endovascular rescue of a patient where sheath perforation by the IVC filter occurred during IVC filter retrieval is described. REPORT: A 75 year old man underwent retrieval of an IVC filter that had been in place for 10 months. Using the IVC filter retrieval set from a standard right internal jugular vein approach and the loop-snare technique, the hook and collet were captured, and the filter was collapsed into the retrieval sheath. Approximately halfway through removal of the filter through the sheath, mild resistance was encountered and the tip of the IVC filter was found to have perforated the side of the retrieval sheath. The sheath appeared to have bent slightly in this region, probably weakening the sheath wall and creating angulation, which allowed sheath perforation to occur. From a right common femoral vein approach, an Amplatz wire was used to cannulate the distal end of the perforated sheath. A balloon was then used to pull the perforated sheath with the IVC filter into a larger sheath. After removing the Tuohy-Borst and Luer adapters on the perforated sheath, it was able to be internalised and removed via the femoral vein sheath. DISCUSSION: The endovascular rescue technique described herein may prove useful to other practitioners encountering similar situations, and the complication shows areas of caution when using the loop-snare retrieval technique.

Hybrid Endovascular Treatment of Dysphagia Lusoria: Report of 2 Cases.

Dysphagia Lusoria is a condition when aberrant right subclavian artery (ARSA) causes esophageal compression. We report 2 cases of Dysphagia Lusoria treated by hybrid endovascular technique which included subclavian to carotid transposition and embolization of origin of ARSA. By using this technique, we avoided the need for thoracotomy. Both patients had complete symptom relief without any surgery related complication.

Percutaneous thrombectomy of mural aortic thrombus using intravascular ultrasound guidance.

Mural aortic thrombus is a challenging clinical problem with significant potential complications. Particularly precarious are situations with involvement of the visceral segment of the aorta. We describe a technique for percutaneous thrombectomy of mural aortic thrombus using intravascular ultrasound to guide an angled mechanical thrombectomy catheter in conjunction with a continuous aspiration system (Indigo mechanical thrombectomy system; Penumbra, Alameda, Calif). Use of this technique in three patients with challenging cases of mural aortic thrombus is discussed. All patients were treated successfully and without complication using this technique.

Successful Percutaneous Retrieval of IVC Filter with Wide Retroperitoneal Penetration Presenting with Gastrointestinal Bleeding.

Symptomatic penetration of the retroperitoneal structures by inferior vena cava (IVC) filter is a rare clinical entity. Vast majority of these patients require laparotomy and open retrieval of the filter. We report a case of a filter penetrating into the duodenum within two months of implantation resulting in gastrointestinal bleeding. The patient was successfully managed with percutaneous retrieval of the filter, blood transfusion and serial abdominal examination thus avoiding laparotomy.