Comparing Different Registration and Visualization Methods for Navigated Common Femoral Arterial Access-A Phantom Model Study Using Mixed Reality.

Mixed reality (MxR) enables the projection of virtual three-dimensional objects into the user's field of view via a head-mounted display (HMD). This phantom model study investigated three different workflows for navigated common femoral arterial (CFA) access and compared it to a conventional sonography-guided technique as a control. A total of 160 punctures were performed by 10 operators (5 experts and 5 non-experts). A successful CFA puncture was defined as puncture at the mid-level of the femoral head with the needle tip at the central lumen line in a 0° coronary insertion angle and a 45° sagittal insertion angle. Positional errors were quantified using cone-beam computed tomography following each attempt. Mixed effect modeling revealed that the distance from the needle entry site to the mid-level of the femoral head is significantly shorter for navigated techniques than for the control group. This highlights that three-dimensional visualization could increase the safety of CFA access. However, the navigated workflows are infrastructurally complex with limited usability and are associated with relevant cost. While navigated techniques appear as a potentially beneficial adjunct for safe CFA access, future developments should aim to reduce workflow complexity, avoid optical tracking systems, and offer more pragmatic methods of registration and instrument tracking.

Awareness of smoking cessation amongst German vascular surgeons.

Background: Smoking represents the well-known enemy of vascular well-being. Numerous previous studies emphasised the important role of smoking on the development and progression of atherosclerotic cardiovascular disease. The current study aimed to identify hurdles and barriers for an insufficient implementation of secondary prevention in the treatment of lower extremity peripheral arterial disease (PAD). Methods: All members of the German Society for Vascular Surgery and Vascular Medicine (DGG) with valid email addresses were invited to participate in an electronic survey on smoking. Results are descriptively presented. Results: Amongst 2716 invited participants, 327 (12%) submitted complete responses, thereof 33% women and 80% between 30 and 59 years old (87% board certified specialists). 83% were employed by hospitals (56% teaching hospital, 14% university, 13% non-academic) and 16% by outpatient facilities. 6% are active smokers (63% never) while a mean of five medical education activities on smoking cessation were completed during the past five years of practice. Only 27% of the institutions offered smoking cessation programs and 28% of the respondents were aware of local programs while a mean of 46% of their patients were deemed eligible for participation. 63% of the respondents deemed outpatient physicians primarily responsible for smoking cessation, followed by medical insurance (26%). Conclusions: The current nationwide survey of one scientific medical society involved in the care of patients with vascular disease revealed that smoking cessation, although being commonly accepted as important pillar of comprehensive holistic care, is not sufficiently implemented in everyday clinical practice.

Sex disparities in popliteal artery aneurysms.

OBJECTIVE: Only 5% of patients with popliteal artery aneurysms (PAAs) are female. Evidence on PAA treatment and outcomes in women is therefore scarce. The POPART Registry provides one of Europe's largest data collections regarding PAA treatment. Data on clinical presentation, aneurysm morphology, and perioperative outcomes after open surgical PAA repair in women will be presented. METHODS: POPART is a multicenter, noninterventional registry for open and endovascular PAA repair, with 42 participating centers in Germany and Luxembourg. All patients aged >18 years who have been treated for PAA since 2010 are eligible for study inclusion. Data collection is based on an online electronic case report form. RESULTS: Of the 1236 PAAs, 58 (4.8%) were in women. There were no significant differences in age or cardiopulmonary comorbidities. However, female patients had a lower prevalence of contralateral PAAs and abdominal aortic aneurysms (P < .05). PAAs in women were more likely to be symptomatic before surgery (65.5% vs 49.4%; P = .017), with 19% of women presenting with acute limb ischemia (vs 11%; P = .067). Women had smaller aneurysm diameters than men (22.5 mm vs 27 mm; P = .004) and became symptomatic at smaller diameters (20 mm vs 26 mm; P = .002). Only 8.6% of women and 11.6% of men underwent endovascular aneurysm repair (P > .05); therefore, the perioperative outcome analysis focused on open surgical repair. In total, 23.5% of women and 16.9% of men developed perioperative complications (P > .05). There were no differences in major cardiovascular events (P > .05), but women showed a higher incidence of impaired wound healing (15.7% vs 7.2%; P = .05) and major amputation (5.9% vs 1.1%; P = .027). Female sex was significantly associated with the need for nonvascular reinterventions within 30 days after surgery (odds ratio: 2.48, 95% confidence interval: 1.26-4.88), whereas no significant differences in the odds for vascular reinterventions were observed (odds ratio: 1.98, 95% confidence interval: 0.68-5.77). In the multiple logistic regression model, female sex, symptomatic PAAs, poor quality of outflow vessels, and graft material other than vein graft were independently associated with perioperative reinterventions. CONCLUSIONS: Women have smaller PAAs, are more likely to be symptomatic before treatment, and are more often affected by nonvascular reinterventions in the perioperative course. As our understanding of aneurysmatic diseases in women continues to expand, sex-specific treatment strategies and screening options for women in well-selected cohorts with modified screening protocols should be continuously re-evaluated.

Standing the test of time: total aortic remodeling 13 years after TEVAR for acute type B aortic dissection.

Long-term outcome after thoracic endovascular aortic repair (TEVAR) of acute type B aortic dissection (aTBAD) is still underreported in current literature. This case report shows persistence of aortic remodeling without secondary complication or need of reintervention 13 years after TEVAR. A 45-year-old woman was referred to the emergency room with aTBAD. Due to early diameter progression in combination with therapy-refractory pain and uncontrolled hypertension, TEVAR was performed. Hereafter, the patient showed complete remodeling of the descending thoracic aorta without persistent false lumen perfusion in this segment and with stable true and false lumen diameter in the untreated abdominal segment for a 13-year period. No aortic-related reintervention was needed. With contemporary devices and adapted therapy, TEVAR seems able to treat complex thoracic disease. Long-term follow-up (FU) is mandatory to monitor the efficacy and durability of endovascular treatment in aortic disease.

A sensorized modular training platform to reduce vascular damage in endovascular surgery.

PURPOSE: Endovascular interventions require intense practice to develop sufficient dexterity in catheter handling within the human body. Therefore, we present a modular training platform, featuring 3D-printed vessel phantoms with patient-specific anatomy and integrated piezoresistive impact force sensing of instrument interaction at clinically relevant locations for feedback-based skill training to detect and reduce damage to the delicate vascular wall. METHODS: The platform was fabricated and then evaluated in a user study by medical ([Formula: see text]) and non-medical ([Formula: see text]) users. The users had to navigate a set of guidewire and catheter through a parkour of 3 modules including an aneurismatic abdominal aorta, while impact force and completion time were recorded. Eventually, a questionnaire was conducted. RESULTS: The platform allowed to perform more than 100 runs in which it proved capable to distinguish between users of different experience levels. Medical experts in the fields of vascular and visceral surgery had a strong performance assessment on the platform. It could be shown, that medical students could improve runtime and impact over 5 runs. The platform was well received and rated as promising for medical education despite the experience of higher friction compared to real human vessels. CONCLUSION: We investigated an authentic patient-specific training platform with integrated sensor-based feedback functionality for individual skill training in endovascular surgery. The presented method for phantom manufacturing is easily applicable to arbitrary patient-individual imaging data. Further work shall address the implementation of smaller vessel branches, as well as real-time feedback and camera imaging for further improved training experience.

"Mixed Reality" in patient education prior to abdominal aortic aneurysm repair.

Background: To investigate the usability of Mixed-Reality (MR) during patient education in patients scheduled for abdominal aortic aneurysm (AAA) repair. Patients and methods: Consecutive patients scheduled for elective AAA repair were block-randomized in either the Mixed-Reality group (MR group) or the conventional group (control group). Patients of both groups were educated about open and endovascular repair of their respective AAA. The MR group was educated using a head-mounted display (HMD) demonstrating a three-dimensional virtual reconstruction of the respective patient's vascular anatomy. The control group was educated using a conventional two-dimensional monitor to display the patient's vasculature. Outcomes were informational gain as well as patient satisfaction with the educational process. (DRKS-ID: DRKS00025174). Results: 50 patients were included with 25 patients in either group. Both groups demonstrated improvements in scores in the Informational Gain Questionnaire (IGQ) when comparing pre- and post-education scores. (MR group: 6.5 points (±1.8) versus 7.9 points (±1.5); Control group: 6.2 points (±1.8) versus 7.6 points (±1.6); p<0.01) There was no significant difference between the MR group and the control group either in informational gain (MR group: 1.4±1.8; Control group: 1.4±1.8; p=0.5) nor in patient satisfaction scores (MR group: mean 18.3 of maximum 21 points (±3.7); Control group: mean 17 of 21 points (±3.6); p=0.1) Multiple regression revealed no correlation between the use of MR and informational gain or patient satisfaction. Usability of the system was rated high, and patients' subjective assessment of MR was positive. Conclusions: The use of MR in patient education of AAA patients scheduled for elective repair is feasible. While patients reported positively on the use of MR in education, similar levels of informational gain and patient satisfaction can be achieved with MR and conventional methods.

Mixed reality for the assessment of aortoiliac anatomy in patients with abdominal aortic aneurysm prior to open and endovascular repair: Feasibility and interobserver agreement.

OBJECTIVES: The objective is to evaluate the feasibility and interobserver agreement of a Mixed Reality Viewer (MRV) in the assessment of aortoiliac vascular anatomy of abdominal aortic aneurysm (AAA) patients. METHODS: Fifty preoperative computed tomography angiographies (CTAs) of AAA patients were included. CTAs were assessed in a mixed reality (MR) environment with respect to aortoiliac anatomy according to a standardized protocol by two experienced observers (Mixed Reality Viewer, MRV, Brainlab AG, Germany). Additionally, all CTAs were independently assessed applying the same protocol by the same observers using a conventional DICOM viewer on a two-dimensional screen with multi-planar reconstructions (Conventional viewer, CV, GE Centricity PACS RA1000 Workstation, GE, United States). The protocol included four sets of items: calcification, dilatation, patency, and tortuosity as well as the number of lumbar and renal arteries. Interobserver agreement (IA, Cohen's Kappa, κ) was calculated for every item set. RESULTS: All CTAs could successfully be displayed in the MRV (100%). The MRV demonstrated equal or better IA in the assessment of anterior and posterior calcification (κMRV: 0.68 and 0.61, κCV: 0.33 and 0.45, respectively) as well as tortuosity (κMRV: 0.60, κCV: 0.48) and dilatation (κMRV: 0.68, κCV: 0.67). The CV demonstrated better IA in the assessment of patency (κMRV: 0.74, κCV: 0.93). The CV also identified significantly more lumbar arteries (CV: 379, MRV: 239, p < 0.01). CONCLUSIONS: The MRV is a feasible imaging viewing technology in clinical routine. Future efforts should aim at improving hologram quality and enabling accurate registration of the hologram with the physical patient.

[Mixed Reality in Vascular Surgery - a Scoping Review]. / Mixed Reality in der Gefäßchirurgie ­ ein Scoping Review.

BACKGROUND: "Mixed reality" (MR) allows the projection of virtual objects into the user's field of view through a head-mounted display (HMD). In the interventional and surgical treatment of vascular diseases MR applications could be of future benefit. The following scoping review aims to provide orientation on the current application of the aforementioned technologies in the field of vascular surgery and to define research goals for the future. METHODS: A systematic literature search was performed in PubMed (MEDLINE) using the search terms "aorta", "intervention", "endovascular intervention", "vascular surgery", "aneurysm", "endovascular", "vascular access", each in combination with "mixed reality" or "augmented reality". The search was performed according to PRISMA (Preferred Reporting Items for Systematic reviews and Meta-Analyses) guidelines for scoping reviews. RESULTS: From 547 references 8 relevant studies were identified. The search results could be classified into two categories: (1) MR aimed at information management and improving periprocedural ergonomics (n = 3) and (2) MR aimed at intraoperative navigation (n = 5). The registration of the physical patient with the virtual object and the tracking of instruments in the MR environment for intraoperative navigation is currently the focus of scientific interest and could be demonstrated on phantom and animal models with technical success. However, the methods presented so far are associated with high infrastructural costs and important limitations. CONCLUSION: The use of MR in the field of vascular surgery is promising. For the future, alternative, pragmatic registration methods with appropriate quantification of the positional error should be aimed at. The developed software and hardware solutions should be adapted to the requirements of vascular surgery. Electromagnetic instrument tracking appears to be a useful complementary technology for the implementation of MR-assisted navigation.

Editor's Choice - Association Between Peri-OPerative Aspirin ResisTance and CardioVascular Outcome (POPART-CVO): a Prospective Non-Interventional Cohort Study.

OBJECTIVE: New onset aspirin resistance during surgery, known as peri-operative aspirin resistance, is observed in up to 30% of vascular surgery patients and is associated with post-operative myocardial damage; questioning aspirin effectiveness towards peri-operative cardiovascular events. The objective of this study was to prospectively evaluate whether peri-operative aspirin resistance in vascular surgery is associated with an adverse cardiovascular outcome. METHODS: Based on a sample size calculation, 194 adult elective vascular or endovascular surgery patients receiving aspirin were analysed in this prospective, single centred, non-interventional cohort study. Platelet function was measured before surgery, one hour after incision, four hours post-operatively, and on the morning of the first and second post-operative days using the Multiplate analyser. The primary outcome was myocardial injury after non-cardiac surgery (MINS). Secondary outcomes included major bleeding, admission to intensive care unit, length of hospital stay, and major adverse cardiac and cerebrovascular events. Subgroup analyses were performed for patients with different cardiovascular risk and for patients who underwent endovascular surgery. RESULTS: Peri-operative aspirin resistance was observed in 27.8% of patients but was not associated with MINS (27.8% vs. 32.1%, aspirin resistance vs. no aspirin resistance, OR 0.812, 95% CI 0.406 - 1.624, p = .56) or with any of the secondary endpoints (all p > .050). In nine of the 10 subgroup analyses, aspirin resistance was not associated with a difference in MINS rate. However, in patients with a low cardiovascular risk profile (RCRI 0-2), MINS occurred more frequently in patients without aspirin resistance (p = .049). CONCLUSION: This study confirmed previous reports demonstrating that peri-operative aspirin resistance is common in patients undergoing vascular or endovascular surgery. However, in patients who continue aspirin throughout the peri-operative period, aspirin resistance is a phenomenon, which does not appear to be related to MINS. Measuring peri-operative platelet function using the Multiplate analyser with the intention to identify and potentially prevent or treat peri-operative aspirin resistance seems to be dispensable.

Thoracic Endovascular Aortic Repair (TEVAR) First in Patients with Lower Limb Ischemia in Complicated Type B Aortic Dissection: Clinical Outcome and Morphology.

Acute Type B aortic dissection (TBAD) can cause organ malperfusion, e.g., lower limb ischemia (LLI). Thoracic endovascular aortic repair (TEVAR) represents the standard treatment for complicated TBAD; however, with respect to LLI, data is scant. The aim of this study was to investigate clinical and morphological outcomes in patients with complicated TBAD and LLI managed with a "TEVAR-first" policy. Between March 1997 and December 2021, 731 TEVAR-procedures were performed, including 106 TBAD-cases. Cases with TBAD + LLI were included in this retrospective analysis. Study endpoints were morphological/clinical success of TEVAR, regarding aortic and extremity-related outcome, including extremity-related adjunct procedures (erAP) during a median FU of 28.68 months. A total of 20/106 TBAD-cases (18.8%, 32-82 years, 7 women) presented with acute LLI (12/20 Rutherford class IIb/III). In 15/20 cases, true lumen-collapse (TLC) was present below the aortic bifurcation. In 16/20 cases, TEVAR alone resolved LLI. In the remaining four cases, erAP was necessary. A morphological analysis showed a relation between lower starting point and lesser extent of TLC and TEVAR success. No extremity-related reinterventions and only one major amputation was needed. The data strongly suggest that aTEVAR-first-strategy for treating TBAD with LLI is reasonable. Morphological parameters might be of importance to anticipate the failure of TEVAR alone.

Late Endograft Migration After Thoracic Endovascular Aortic Repair: A Systematic Review and Meta-analysis.

PURPOSE: The objective of this systematic review was to report the cumulative incidence of endograft migration (EM), as well as the morbidity, reintervention rates, and mortality related to EM. This study aimed to provide evidence-based data on patient-relevant sequelae of EM after thoracic endovascular aortic repair (TEVAR) performed using contemporary aortic endografts. MATERIALS AND METHODS: A systematic electronic search of literature in MEDLINE (via PubMed), Web of Science, and Cochrane Central Register of Controlled Trials was performed. The pooled synthesis of outcomes was performed using the inverse variance method. RESULTS: Seven prospective non-randomized and 4 retrospective studies, including a total of 1783 patients presenting 70 EMs, were considered for the quantitative analysis. The pooled rate of EM was 4% (95% CI, 2%-7%; range, 0.2%-11%; I2=82%); pooled morbidity rate was 31% (95% CI, 12%-59%; range, 0%-100%; I2=64%) and pooled reintervention rate was 32% (95% CI, 15%-56%; range, 0%-100%; I2=55%). The pooled mortality rate due to EM was 5% (95% CI, 1%-21%; range, 0%-40%; I2=24%). CONCLUSION: For the first time, this meta-analysis provides pooled reference estimates of EM after TEVAR. Thus, the results hold the potential to further characterize EM after TEVAR. The clinical relevance of EM is underlined by its association with high rates of endoleak-related morbidity, reintervention, and mortality. Close standardized surveillance after TEVAR for early detection of EM and prophylaxis of its sequelae is essential.

Mixed-Reality-Assisted Puncture of the Common Femoral Artery in a Phantom Model.

Percutaneous femoral arterial access is daily practice in a variety of medical specialties and enables physicians worldwide to perform endovascular interventions. The reported incidence of percutaneous femoral arterial access complications is 3-18% and often results from suboptimal puncture location due to insufficient visualization of the target vessel. The purpose of this proof-of-concept study was to evaluate the feasibility and the positional error of a mixed-reality (MR)-assisted puncture of the common femoral artery in a phantom model using a commercially available navigation system. In total, 15 MR-assisted punctures were performed. Cone-beam computed tomography angiography (CTA) was used following each puncture to allow quantification of positional error of needle placements in the axial and sagittal planes. Technical success was achieved in 14/15 cases (93.3%) with a median axial positional error of 1.0 mm (IQR 1.3) and a median sagittal positional error of 1.1 mm (IQR 1.6). The median duration of the registration process and needle insertion was 2 min (IQR 1.0). MR-assisted puncture of the common femoral artery is feasible with acceptable positional errors in a phantom model. Future studies should aim to measure and reduce the positional error resulting from MR registration.

[Discuss Many to Benefit More - Five-Year Analysis of a Multidisciplinary Aortic Board]. / Discuss Many to Benefit More ­ Fünf-Jahres-Analyse eines interdisziplinären Aortenkolloquium.

BACKGROUND: Multidisciplinary aortic boards (mAB) are a valuable tool for decision making in patients with aortic pathologies. The aim of this study was to evaluate the mAB of a maximum care hospital with regards to total patient volume and discipline-specific presentations. Furthermore, the indications for conservative/surgical treatment and the patients' allocation were reviewed. METHODS: A retrospective analysis was performed of all patients discussed in the mAB of Heidelberg University Hospital (Department of Vascular and Endovascular Surgery [VS]/Department of Cardiac Surgery [CS]/Department of Radiology), between 01/2014 and 12/2018. RESULTS: Within a five-year period, 344 patients (median of 71 patients/year) were discussed. Of those, 262 (76%) were presented by VS, mostly recruited from the outpatient sector. Another 63 cases (18%), originated from CS and 19 patients (6%) from other disciplines. An indication for surgical treatment was defined in 153 of 344 patients (45%), whereas 191 of 344 cases (55%) were treated in a conservative fashion. Procedures performed by VS were indicated in 85/153 (55%) cases, including 25% (22/85) of non-VS-patients. Procedures performed by CS were indicated in 68/153 (45%) cases containing 84% (57/68) of non-CS-patients. Despite a dedicated indication for surgery, 59/153 patients (39%) did not receive the recommended therapy. CONCLUSION: mAB maintenance is highly dependent on the outpatient sector. With respect to patient selection, the mAB has an important filter function towards conservative treatment. The nearly balanced distribution between VS and CS underlines the importance of a multidisciplinary approach to aortic surgery. Given the relevant number of untreated patients, a central management office with an in-hospital registry seems crucial in order to improve mAB performance.

A 10-Year Single-Center Experience With the GORE TAG Conformable Thoracic Stent Graft in the Treatment of Thoracic Aortic Disease.

OBJECTIVE: The aim of this study was to report 10-year real-world single-center experience with the GORE TAG conformable thoracic aortic graft (CTAG), focusing on rupture-free survival, aortic-related reintervention, and device-related complications during midterm and long-term follow-up (FU). METHODS: This retrospective study analyzes results of thoracic endovascular aortic repair (TEVAR) performed between January 2009 and December 2018. Out of 419 TEVAR procedures within this period, 194 patients (male 57.2%, 111/194), with a mean age of 65 ± 13 years, were treated with the CTAG device. Indication for TEVAR was a thoracic aortic aneurysm in 24.7% (48/194), type B aortic dissection in 32.5% (63/194), penetrating aortic ulcer 15.5% (30/194), and miscellaneous 27.3% (53/194). Emergently were operated 43.8% (85/194) patients. Median follow-up (FU) including computed tomography imaging was 43.5 months (Q1-Q3: 8.6-67.0) and was completed in 91.2% (177/194) of patients. RESULTS: Overall survival rates were 75.8% (95% confidence interval [CI] = [0.76-0.70]) and 56.6% (95% CI = [0.57-0.50]) at 12 and 60 months, respectively. Cumulative incidence for aortic rupture was 11.9% (95% CI = [0.07-0.17]) at 60 and 90 months, respectively. Cumulative incidence for aortic-related reintervention was 27.5% (95% CI = [0.21-0.34]) at 60 and 90 months. Cumulative incidence for migration was 2.8% (95% CI = [0.004-0.05]) and 3.9% (95% CI = [0.007-0.07]) at 60 and 90 months, respectively. New endograft infections or material fatigue were not observed. CONCLUSIONS: The herein reported 10-year real-world single-center experience with the CTAG observed favorable long-term outcome. Thus, the device demonstrates appropriate persistent safety, efficacy, and clinical durability up to long-term FU in the treatment of diverse thoracic aortic pathologies.

TEVAR Following FET: Current Outcomes of Rendezvous Procedures in Clinical Practice.

BACKGROUND: The treatment of extensive thoracic/thoracoabdominal aortic pathologies with arch involvement remains a challenging task in aortic surgery. The introduction of the frozen elephant trunk (FET) technique offered a link between open surgery and thoracic endovascular aortic repair (TEVAR). Despite a decade of experience, data on the complementary use of these techniques are scant. The aim of this study was to evaluate TEVAR following FET in clinical reality. METHODS: Between November 2006 and June 2018, 20 patients (9 females; median age of 69 years) underwent endovascular second-stage completion after FET. The clinical outcomes, technical feasibility, and morphological findings were analyzed retrospectively. RESULTS: Eleven of the 20 interventions were intended "rendezvous procedures" in a multistage approach; 4 were elective reinterventions, and 5 were emergency complication repairs. The median interval between FET and TEVAR was 231 days (11 days-7.4 years). The technical success rate was 100%. During a median follow-up (FU) period of 58.3 months, the overall survival rate was 95%, with one in-hospital death. Neurological complications occurred in three cases (spinal cord injury: n = 1; stroke: n = 2). Computed tomography angiography showed overall regression in the median diameter of the proximal descending aorta (from 57 to 48.5 mm). CONCLUSION: TEVAR as a second-stage intervention after FET is a feasible option, with satisfactory results at medium-term FU. In extensive thoracoabdominal aortic disease without proximal landing zones, the complementary use of both techniques in a multistage approach should be considered.

Dynamic Morphology of the Ascending Aorta and Its Implications for Proximal Landing in Thoracic Endovascular Aortic Repair.

In this study, we assessed the dynamic segmental anatomy of the entire ascending aorta (AA), enabling the determination of a favorable proximal landing zone and appropriate aortic sizing for the most proximal thoracic endovascular aortic repair (TEVAR). Methods: Patients with a non-operated AA (diameter < 40 mm) underwent electrocardiogram-gated computed tomography angiography (ECG-CTA) of the entire AA in the systolic and diastolic phases. For each plane of each segment, the maximum and minimum diameters in the systole and diastole phases were recorded. The Wilcoxon signed-rank test was used to compare aortic size values. Results: A total of 100 patients were enrolled (53% male; median age 82.1 years; age range 76.8−85.1). Analysis of the dynamic plane dimensions of the AA during the cardiac cycle showed significantly higher systolic values than diastolic values (p < 0.001). Analysis of the proximal AA segment showed greater distal plane values than proximal plane values (p < 0.001), showing a reversed funnel form. At the mid-ascending segment, the dynamic values did not notably differ between the distal plane and the proximal segmental plane, demonstrating a cylindrical form. At the distal segment of the AA, the proximal plane values were larger than the distal segmental plane values (p < 0.001), thus generating a funnel form. Conclusions: The entire AA showed greater systolic than diastolic aortic dimensions throughout the cardiac cycle. The mid-ascending and distal-ascending segments showed favorable forms for TEVAR using a regular cylindrical endograft design. The most proximal segment of the AA showed a pronounced conical form; therefore, a specific endograft design should be considered.

Outcome analysis of the Gore Conformable Thoracic Stent Graft with active control system for the treatment of arch and descending thoracic aortic disease.

OBJECTIVES: The aim of this study was to evaluate technical/clinical outcomes of the Gore TAG Conformable Thoracic Stent Graft with Active Control System (CTAG with ACS) in thoracic aortic disease since its introduction in Europe in 2017. METHODS: Patients undergoing thoracic endovascular aortic repair (TEVAR) with the device between 2017 and 2020 were identified from a prospectively maintained single-centre database and retrospectively analysed. Predominant indications were aortic dissection (n = 46), thoracic/thoraco-abdominal aneurysm (n = 20/n = 7), penetrating ulcer (n = 14) and intramural haematoma (n = 12). Emergency procedures were performed in 47% (54/115). The primary outcome was technical success. Secondary outcomes were clinical success, serious adverse events and procedure-related reintervention. ACS was assessed regarding angulation, accuracy and apposition. The median follow-up was 8.46 months (interquartile range: 3.18-16.89 months). RESULTS: A total of 115 consecutive patients (82 males, median age 63; interquartile range: 53-74 years) have been included. Technical success was achieved in 95.7% (110/115). Clinical success rate was 80.9% (93/115); mostly due to procedure-related death (n = 14). Overall mortality was 19.1% (22/115), with significant differences between elective/emergency procedures (log-rank: P < 0.001). Procedure-related serious adverse event rate was 44.3% (51/115). Procedure-related reintervention was performed in 20.9% (24/115). The cumulative incidence for reintervention differed significantly between elective/emergency cases (Gray's test: P = 0.0033). Angulation was used in 40.9% of patients (47/115), mostly in type II arches (52.7%). Deployment accuracy was 87.8% (101/115). Sufficient apposition was present in 93.0% (107/115). CONCLUSIONS: This single-centre study shows encouraging performance of the CTAG with ACS in an array of aortic pathologies. Although longer-term data must be awaited, ACS leads to overall favourable device placement. Despite ongoing advances in device technology, TEVAR remains challenging and is associated with significant burden inherent to the underlying disease.

Midterm single-center results after endovascular aneurysm sealing reveal a high rate of stent graft migration, secondary aneurysm ruptures, and device-related reinterventions.

OBJECTIVE: To report procedural results and mid-term follow-up outcomes of patients treated with endovascular aneurysm sealing (EVAS) for abdominal aortic disease. METHODS: In this retrospective observational study, all patients treated with EVAS between March 2013 and January 2018 for abdominal aortic aneurysm (AAA) or abdominal penetrating aortic ulcer were included. The datasets included demographics, aneurysm morphology, and procedural and clinical surveillance outcomes. Furthermore, patients treated within the original instructions for use (IFU-group) were compared with patients treated outside the IFU (non-IFU-group) with regard to survival, reintervention-free survival, freedom from type I endoleak, and freedom from stent graft migration. RESULTS: Seventy patients were included (67 male; median age, 72.5 years). Sixty-five patients were treated for AAA and 5 patients for abdominal penetrating aortic ulcer. Sixty-nine cases were treated electively (98.6%). Technical success was achieved in 68 cases (97.1%). The median clinical follow-up was 50.5 months (interquartile range, 29.3-62.7 months) with a median computed tomography angiographic follow-up of 38.5 months (interquartile range, 17.1-60.2 months). There were five deaths during the study period (7.1%), four of which were aneurysm related (5.7%). Five secondary AAA ruptures were detected (7.1%). Overall, 25 of 70 patients (35.7%) underwent 35 reinterventions, mostly owing to thrombotic complications (18.6%), stent graft migration (17.1%), and type I endoleak (12.9%). Fifteen patients were treated outside of the IFU (non-IFU-group) (21.4%). The estimated reintervention-free survival for the entire cohort at 30 days and 1, 3, and 5 years was 94.3%, 88.5%, 72%, and 56.9%, respectively. Freedom from stent graft migration at 1, 3, and 5 years was 98.6%, 82.0%, and 47.3%, respectively. The estimated freedom from type I endoleak at 30 days and 1, 3, and 5 years in the IFU-group was 100%, 100%, 94.9% and, 91.1% and significantly different when compared with the non-IFU-group with 79.5%, 72.2%, 72.2%, and 72.2% (P = .012). CONCLUSIONS: Although the technical and initial results were satisfying, the mid-term results were disappointing. The enforcement of a close follow-up protocol for all patients treated with EVAS, especially vigilant for stent graft migration to prevent secondary type I endoleak and rupture, is strongly recommended.

Isolated femoral artery revascularisation with or without iliac inflow improvement - a less invasive surgical option in critical limb ischemia.

Background: Isolated femoral artery revascularisation (iFAR) represents a well-established surgical method in the treatment of peripheral arterial disease (PAD) involving common femoral artery disease. Data for iFAR in multilevel PAD are inconsistent, particularly in patients with critical limb ischemia (CLI). The aim of the study was to evaluate the outcome of iFAR in CLI regarding major amputation and reintervention and to identify associated risk factors for this outcome. Patients and methods: The data used have been derived from the German Registry of Firstline Treatment in Critical Limb Ischemia (CRITISCH). A total of 1200 patients were enrolled in 27 vascular centres. This sub-analysis included patients, which were treated with iFAR with/without concomitant iliac intervention. For detection of risk factors for the combined endpoint of major amputation and/or reintervention, selection of variables for multiple regression was conducted using stepwise forward/backward selection by Akaike's information criterion. Results: 95 patients were included (mean age: 72 years ± 10.82; 64.2% male). Of those, 32 (33.7%) participants reached the combined endpoint. Risk factor analysis revealed continued tobacco use (odds ratio [OR] 2.316, confidence interval [CI] 0.832-6.674), TASC D-lesion (OR: 2.293, CI: 0.869-6.261) and previous vascular intervention in the trial leg (OR: 2.720, CI: 1.037-7.381) to be associated with reaching the combined endpoint. Conclusions: iFAR provides a reasonable, surgical option to treat CLI. Lesion length (TASC D) seems to have a negative impact on outcome. Further research is required to better define the future role of iFAR for combined femoro-popliteal lesions in CLI - best in terms of a randomised controlled trial.