First-in-Human Clinical Application of the Medyria TrackCath System in Endovascular Repair of Complex Aortic Aneurysms (ACCESS Trial): A Prospective Multicenter Single-Arm Clinical Trial.

PURPOSE: The Medyria TrackCath Catheter (MedTCC) is an innovative, thermal convection-based blood flow velocity (BFV) tracking catheter that may be used during complex aortic endovascular procedures for identification and catheterization of target orifices. The ACCESS Trial analyzes the safety and performance of the MedTCC for targeted vessel catheterization to generally evaluate the feasibility of thermal convection-based BFV. MATERIALS AND METHODS: We performed a first-in-human, proof-of-concept, prospective single-arm multicenter clinical trial between March 2018 and February 2019 in patients who underwent endovascular aortic procedures at 4 high-volume centers. During these procedures, the MedTCC was advanced over a guidewire through the femoral access. The D-shape was enfolded in the reno-visceral part of the aorta and target orifices were identified and catheterized with a guidewire via the side port of the MedTCC through BFV tracking. BFV measurements were performed at baseline (Baseline-BFV), alignment to the orifice (Orifice-BFV), and following catheterization (Confirmation-BFV) to prove correct identification and catheterization of target orifices. The procedural success rate, the catheterization success rate, procedure-related parameters, and (serious) adverse events ((S)AE) during the follow-up were analyzed. RESULTS: A total of 38 patients were included in the safety group (SG) and 26 in the performance group (PG). The procedural success rate was 89% (PG), the MedTCC catheterization success rate was 98% (PG). The MedTCC reliably measured BFV changes indicated by significant differences in BFV between Baseline-BFV and Orifice-BFV (p<0.05). Median (interquartile range; IQR) fluoroscopy time per orifice was 5.0 (1.5-8.5) minutes [total surgery 49 (26-74) minutes], median (IQR) contrast agent used per orifice was 1.0 (0-5.0) mL [total surgery 80 (40-100) mL], and median (IQR) MedTCC-based procedural time was 3.0 (2.0-6.0) minutes. There was no device-related SAE. CONCLUSIONS: The ACCESS Trial suggests that BFV measurement allows for reliable target orifice identification and catheterization. The use of MedTCC is safe and generates short fluoroscopy time and low contrast agent use, which in turn might facilitate complex endovascular procedures.

Contemporary Surgical Management of Aberrant Right Subclavian Arteries (Arteria Lusoria).

BACKGROUND: An aberrant right subclavian artery (ARSA) is in most cases an asymptomatic aortic arch anomaly. However, dysphagia, aneurysm formation (ARSAA), associated Kommerell diverticulum, or cerebellar/arm malperfusion may require invasive therapy. Large-scale clinical trials do not exist in current literature. We report our patient's outcome of a single-center experience and delineate indications for treatment and surgical techniques. METHODS: A single-center retrospective study was conducted between January 1, 2012 through March 1, 2018. Symptomatic or asymptomatic patients with ARSAA who received invasive treatment at the Department for Vascular and Endovascular Surgery, University Hospital Dusseldorf, Germany were included. RESULTS: Eight patients (4 men, 63 ± 14 (39-78) years) were treated with single-stage (n = 4) or multistage (n = 4) procedures. Treatment for ARSAA (n = 4) included ARSA revascularization (subclavian-carotid transposition (SCT) = 3; carotid-subclavian bypass (CSB) = 1), aortic arch debranching (left SCT = 2, bilateral aorto-carotid bypass + left CSB = 1, right-to-left CSB + left-carotid-to-bypass transposition = 1), and thoracic endovascular aortic repair (TEVAR; n = 4). Other strategies included SCT for dysphagia (n = 2) or subclavian steal syndrome (n = 1) and balloon angioplasty for arm claudication (n = 1). Complications involved vascular access (n = 2) and each one partial common carotid artery overstenting without stroke during TEVAR and Horner syndrome after SCT. Mean follow-up was 23 ± 26 (9-67) months. After 7 months, 1 patient required vertebral artery coiling due to type II endoleak with ARSAA progression. Overall mortality was 0%. Technical and clinical success rates were 100%. CONCLUSIONS: Surgical concepts for ARSA aim on preventing aneurysm rupture and alleviate dysphagia or ischemic symptoms. To generate satisfying patient outcomes, individualized therapy planning in specialized centers is vital.

The JOTEC iliac branch device for exclusion of hypogastric artery aneurysms: ABRAHAM study.

OBJECTIVE: Hypogastric artery aneurysms (HAAs) are rare but life-threatening in cases of rupture. Open or endovascular techniques traditionally aimed at occluding the hypogastric artery (HA) have considerable risk of pelvic ischemia. Iliac branch devices (IBDs) are indicated for aortoiliac aneurysms; however, they have also been used lately for HAAs. Currently, there are no reports about patient outcomes focusing on HAA therapy using IBDs. We retrospectively analyzed early and midterm outcomes using IBDs for HAAs. METHODS: Patients who received IBDs for HAAs at our department from January 1, 2012, through March 1, 2018, were included. Exclusion criteria were as follows: no HA involvement, emergency procedures, and HA stent grafting without IBD. Perioperative and follow-up data were collected from medical records. RESULTS: There were 18 IBDs (only IBD, n = 4; IBD + endovascular aneurysm repair [EVAR], n = 7; IBD ± EVAR + side branch occlusion, n = 7) implanted into 14 male patients (76 ± 4 [70-83] years). There were no intraoperative complications, and the technical success rate was 100%. After 19 ± 11 (2-39) months of follow-up, two hybrid (external iliac artery occlusion, n = 1; EVAR graft kinking, n = 1) and four endovascular reinterventions due to two type IB (side branch coiling + stent graft extension) and two type IIIB (stent grafting) endoleaks were required. One IBD-related type II endoleak revealed constant aneurysm diameters during follow-up. One small type IB endoleak was self-limited. Estimated freedom from reintervention was 31% ± 23% at 2.7 years. The clinical success and patency rate was 100%. The IBD-related mortality was 0%. CONCLUSIONS: The IBD for HAA shows good early and midterm results. Adequate sealing of HA landing zones and side branch occlusion are technically challenging but crucial to prevent type IB and type II endoleaks.

Acute Limb Ischemia-Much More Than Just a Lack of Oxygen.

Acute ischemia of an extremity occurs in several stages, a lack of oxygen being the primary contributor of the event. Although underlying patho-mechanisms are similar, it is important to determine whether it is an acute or chronic event. Healthy tissue does not contain enlarged collaterals, which are formed in chronically malperfused tissue and can maintain a minimum supply despite occlusion. The underlying processes for enhanced collateral blood flow are sprouting vessels from pre-existing vessels (via angiogenesis) and a lumen extension of arterioles (via arteriogenesis). While disturbed flow patterns with associated local low shear stress upregulate angiogenesis promoting genes, elevated shear stress may trigger arteriogenesis due to increased blood volume. In case of an acute ischemia, especially during the reperfusion phase, fluid transfer occurs into the tissue while the vascular bed is simultaneously reduced and no longer reacts to vaso-relaxing factors such as nitric oxide. This process results in an exacerbative cycle, in which increased peripheral resistance leads to an additional lack of oxygen. This whole process is accompanied by an inundation of inflammatory cells, which amplify the inflammatory response by cytokine release. However, an extremity is an individual-specific composition of different tissues, so these processes may vary dramatically between patients. The image is more uniform when broken down to the single cell stage. Because each cell is dependent on energy produced from aerobic respiration, an event of acute hypoxia can be a life-threatening situation. Aerobic processes responsible for yielding adenosine triphosphate (ATP), such as the electron transport chain and oxidative phosphorylation in the mitochondria, suffer first, thus disrupting the integrity of cellular respiration. One consequence of this is irreparable damage of the cell membrane due to an imbalance of electrolytes. The eventual increase in net fluid influx associated with a decrease in intracellular pH is considered an end-stage event. Due to the lack of ATP, individual cell organelles can no longer sustain their activity, thus initiating the cascade pathways of apoptosis via the release of cytokines such as the BCL2 associated X protein (BAX). As ischemia may lead to direct necrosis, inflammatory processes are further aggravated. In the case of reperfusion, the flow of nascent oxygen will cause additional damage to the cell, further initiating apoptosis in additional surrounding cells. In particular, free oxygen radicals are formed, causing severe damage to cell membranes and desoxyribonucleic acid (DNA). However, the increased tissue stress caused by this process may be transient, as radical scavengers may attenuate the damage. Taking the above into final consideration, it is clearly elucidated that acute ischemia and subsequent reperfusion is a process that leads to acute tissue damage combined with end-organ loss of function, a condition that is difficult to counteract.

Outcomes after Open Surgery for Inflammatory Abdominal Aortic Aneurysm: A 10-Year Single-Center Experience.

BACKGROUND: Inflammatory abdominal aortic aneurysms (IAAAs) are rare clinical entities with an exaggerated inflammatory component. The aim of this study is to report outcomes of a single-center 10-year experience in open surgical management of IAAA and to compare the results with noninflammatory, atherosclerotic abdominal aortic aneurysms (non-IAAAs). METHODS: We retrospectively reviewed the medical records of 18 patients with IAAA selected out of patients with AAA who underwent open surgery in the Department of Vascular and Endovascular Surgery at the University Hospital Dusseldorf from January 2006 to December 2015. These patients were matched with controls, selected from a prospectively retained database of patients with AAA undergoing open surgery during the study period. A 1:2 case-control match regarding age, gender, and year of treatment was performed. We analyzed both groups for preoperative parameters, intraoperative findings, and early postoperative outcomes. RESULTS: The 2 groups showed considerable similarities with no significant differences in the clinical features. Both groups outlined comparable aneurysm size (62 vs. 56 mm); however, the mean preoperative C-reactive protein was found to be significantly elevated in the study group (mean value: 2.6 vs. 0.9 mg/dL, P < 0.05). Most patients were operated using a standard transperitoneal median laparotomy approach; only 1 patient of each group was operated using a left retroperitoneal approach. There was no significant difference in operation time (190 vs. 194 min) and 30-day mortality 0%. The in-hospital mortality was 11% in the study group and 0% in the control group. We found a significant higher complication rate in the study group 10 (56%) vs. 12 (33%). The major complications were also more frequent in the study group 4 (22%) vs. 6 (16.7%). IAAA showed a statistically significant longer length of intensive care unit and hospital stay when compared with non-IAAA (7 and 20 days vs. 2 and 14 days, P < 0.05). IAAAs outlined a significantly greater transfusion requirement for erythrocytes and fresh frozen plasma than non-IAAA. CONCLUSIONS: Open surgical treatment of IAAA guarantees a regression of the inflammatory process in most patients, which was detected through ultrasound in follow-up examination, although the approach to the surgical site is highly demanding. IAAA exhibits clear gender predominance and is associated with significantly higher transfusion requirement, early morbidity, and length of stay.

Chronic Mesenteric Ischemia: Patient Outcomes Using Open Surgical Revascularization.

BACKGROUND: Chronic mesenteric ischemia (CMI) is a rare disease. Open treatment (OT) remains a valuable treatment option. We analyzed patient outcomes after OT and investigated health-related quality of life (HRQoL). METHODS: Data were analyzed retrospectively. The investigation period was from January 1, 2001, to December 31, 2014. We investigated mortality and patency rates using Kaplan-Meier analysis. HRQoL was measured using a 36-item health survey. Various statistical methods were employed. RESULTS: A total of 100 patients (celiac trunk [TC: n = 23], superior mesenteric artery [SMA: n = 26], or both [n = 51]) were included. Median follow-up was 5 ± 35 months. One-year survival rate for TC was 75 ± 11%, for SMA: 79 ± 10%, and for both: 96 ± 3%. TC 5-year survival was 75 ± 11% (SMA: 57 ± 16%: both: 80 ± 8%). Obesity and the length of hospital stay were independently associated with patient survival (p < 0.05). Primary 1-year patency rate was 60 ± 13% for TC (SMA: 86 ± 10%; both: 71 ± 8%) and secondary 1-year patency rate was 84 ± 9% for TC (SMA: 100%; both: 79 ± 7%). HRQoL was inferior compared to the German normative data (p < 0.05). CONCLUSION: CMI overlaps between gastrointestinal and vascular surgery. OT is safe, and simultaneous revascularization of the TC and the SMA does not affect mortality. Patients would not necessarily benefit from OT in terms of HRQoL.

Open vascular treatment of median arcuate ligament syndrome.

BACKGROUND: Median arcuate ligament syndrome is a rare condition with abdominal symptoms. Accepted treatment options are open release of median arcuate ligament, laparoscopic release of edian arcuate ligament, robot-assisted release of median arcuate ligament and open vascular treatment. Here we aimed to evaluate the central priority of open vascular therapy in the treatment of median arcuate ligament syndrome. METHODS: We conducted a monocentric retrospective study between January 1996 and June 2016. Thirty-one patients with median arcuate ligament syndrome underwent open vascular surgery, including division of median arcuate ligament in 17 cases, and vascular reconstruction of the celiac artery in 14 cases. RESULTS: In a 20-year period, 31 patients (n = 26 women, n = 5 men) were treated with division of median arcuate ligament (n = 17) or vascular reconstruction in combination with division of median arcuate ligament (n = 14). The mean age of patients was 44.8 ± 15.13 years. The complication rate was 16.1% (n = 5). Revisions were performed in 4 cases. The 30-day mortality rate was 0%. The mean in-hospital stay was 10.7 days. Follow-up data were obtained for 30 patients. The mean follow-up period was 52.2 months (range 2-149 months). Patients were grouped into a decompression group (n = 17) and revascularisation group (n = 13). The estimated Freedom From Symptoms rates were 93.3, 77.8, and 69.1% for the decompression group and 100, 83.3, and 83.3% for the revascularisation group after 12, 24 and 60 months respectively. We found no significant difference in the Freedom From Re-Intervention CA rates of the decompression (100% at 12, 24 and 60 months post-surgery) and revascularisation (100% at 12 months, and 91.7% at 24 and 60 months post-surgery) groups during follow-up (p = 0.26). CONCLUSIONS: Open vascular treatment of median arcuate ligament syndrome is a safe, low mortality-risk procedure, with low morbidity rate. Treatment choice depends on the clinical and morphological situation of each patient.

Deep Vein Thrombosis and True Crural Aneurysm: Misdiagnosis or Causal Relation?

True crural artery aneurysm is a rare clinical entity. Crural artery aneurysms are most frequently seen in men in their sixth decade without major cardiopulmonary diseases and are often associated with injury, superinfection, or vasculitis. We report the case of a 44-year-old man with a history of idiopathic deep vein thrombosis (DVT) as the first manifestation of a true crural artery aneurysm. To our knowledge, DVT is very rarely related with true crural artery aneurysms, with only 3 cases reported in the current literature. Open surgical repair is the most common management, with ligation as a second option in emergencies such as rupture. The related literature is discussed. We conclude that crural aneurysms should be considered in differential diagnosis of popliteal DVT in adults. True crural aneurysms need vigilance and a more systematical approach to provide physicians the means to the best medical care.

Iatrogenic Femoral Pseudoaneurysm and Secondary Ipsilateral Deep Vein Thrombosis: An Indication for Early Surgical Exploration.

Pseudoaneurysm formation often complicates transfemoral interventional procedures. Nonsurgical treatment consists of femoral compression and thrombin injection under ultrasound guidance. We report a 74-year-old man who was diagnosed with a pseudoaneurysm, following coronary angiography. Duplex ultrasound revealed deep vein thrombosis of the ipsilateral common femoral vein. Ultrasound-guided thrombin injection was unsuccessfully performed, and the patient subsequently underwent surgical exploration for repair of the pseudoaneurysm and release of the venous compression. The increased local inflammation, because of the thrombosis, added in surgical difficulties. We conclude that early surgical intervention should be considered as a primary strategy in patients with femoral pseudoaneurysms and deep vein thrombosis secondary to femoral compression.

Ruptured Mycotic Aortic Aneurysm after Bacille Calmette-Guerin Therapy.

To report a case of a ruptured mycotic abdominal aortic aneurysm (MAA) after intravesical Bacille Calmette-Guerin (BCG) therapy because of bladder carcinoma. A 57-year-old male patient was admitted to our hospital for follow-up computed tomography 14 months after transurethral resection of a papillary carcinoma of the bladder and intravesical BCG therapy. The CT scan revealed a ruptured MAA aneurysm and the patient underwent an endovascular repair with an aorto-bi-iliac stent graft. A ruptured MAA is a rare but lethal complication after BCG instillation therapy. The standard therapy is the open reconstruction but according to the literature an endovascular therapy in combination with long-term antibiotics should be considered as a bridging or a definite solution.

Endovascular Occlusion of a Renal Arteriovenous Fistula with Renal Vein Aneurysm Formation for Rupture Prevention.

PURPOSE: To report the effectiveness of left renal artery (LRA) occlusion using Amplatzer Vascular Plug (AVP) II as treatment for a high-flow renal arteriovenous fistula (RAVF) with multiple renal vein aneurysms (RVA) to prevent aneurysm rupture and cardiac decompensation. CASE REPORT: A 59-year-old female suffering from a post-traumatic RAVF presented with tachycardia and increased cardiac output (CO). Doppler ultrasonography and computed tomography (CT) scan revealed a high-flow RAVF with multiple RVAs and unilateral critically reduced kidney function. Appreciating recent interventional therapeutic advances, the patient was treated with endovascular placement of AVP II into the left renal artery (LRA) resulting in complete occlusion of the RAVF to effectively reduce the risk of RVA rupture and cardiac decompensation. No anti-platelet medication was administrated after the occlusion of the LRA. The patient's physical capacity improved since right heart volume strain was normalized, and CO was reduced. CONCLUSION: Transbrachial AVP II occlusion of the LRA is effective to occlude high-flow RAVFs to prevent risk of life-threatening RVA rupture. Additional follow-up is warranted to verify long-term effectiveness of this approach.

Spinal meningioma, aortic aneurysms and the missing link of observation: the anchoring heuristic approach.

Over the last three decades, the development of systematic and protocol-based algorithms, and advances in available diagnostic tests have become the indispensable parts of practising medicine. Naturally, despite the implementation of meticulous protocols involving diagnostic tests or even trials of empirical therapies, the cause of one's symptoms may still not be obvious. We herein report a case of chronic back pain, which took about 5 years to get accurately diagnosed. The case challenges the diagnostic assumptions and sets ground of discussion for the diagnostic reasoning pitfalls and heuristic biases that mislead the caring physicians and cost years of low quality of life to our patient. This case serves as an example of how anchoring heuristics can interfere in the diagnostic process of a complex and rare entity when combined with a concurrent potentially life-threatening condition.

Temporal artery biopsy in the diagnosis of giant cell arteritis: Bigger is not always better.

OBJECTIVE: Accurate early giant cell arteritis (GCA) diagnosis can be established through temporal artery biopsy (TAB). We herein investigate the relationship between specimen length and positive TAB result in a tertiary-care hospital in Germany during a 8-year period. Secondarily, we studied the relationships of specific epidemiological and laboratory parameters with positive TABs. METHOD: We retrospectively reviewed the medical records of all patients with suspected GCA, who underwent TAB in our institution. RESULTS: The total sample consisted of 116 patients with a mean age of 76.1 (SD 7.7) years. Mean specimen length post-fixation was 0.94 cm (SD 0.49). The TAB(+) group consisted of 64 patients (55.2%). The specimen length was comparable in the two groups (0.96 cm vs 0.91 cm, p = 0.581). Twenty six TAB(+) patients (41%) had a post-fixation specimen longer than 1 cm, comparable with the respective percentage in the TAB(-) group (42%, p = 1). All laboratory tests performed were statistically significantly different in the two groups. CONCLUSION: We conclude that TAB length is not associated with the TAB diagnostic yield in patients with clinical suspicion of GCA.

Pilomatrix carcinoma: More malignant biological behavior than was considered in the past.

Pilomatrix carcinoma is a very rare malignancy, with ~130 cases reported in the literature. In the past, pilomatrix carcinoma was considered to be a low-grade malignant tumor. Currently, however, its significant recurrence and metastatic potential has been well documented. Lymph node and systemic metastases are frequently observed. Wide surgical excision of the primary lesion is the principal modality of treatment, whereas adjuvant radiotherapy may be beneficial in local tumor control. Lymph node metastases may be treated surgically or with radiotherapy. Systemic disease is not responsive to chemotherapy, and is hence associated with a poor prognosis. Since the majority of nodal and systemic metastases present after the initial diagnosis and treatment, follow-up examinations of these patients may be warranted, despite the currently inadequate treatment options. In the present study, a case of pilomatrix carcinoma of the parotid region with early local recurrence only 2 months after complete excision with negative surgical margins is reported. The local recurrence was treated by excision and radiotherapy. The associated literature is also discussed.