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.

Intravascular Iliac Artery Lithotripsy to Facilitate Aortic Endograft Delivery: Midterm Results of a Dual-Center Experience.

PURPOSE: To assess the feasibility and safety of intravascular lithotripsy (IVL) for enabling transfemoral abdominal (EVAR), thoracic (TEVAR), and thoracoabdominal (BEVAR) endovascular aneurysm repair in patients with narrow and calcified iliac arteries. MATERIALS AND METHODS: Consecutive patients treated with IVL for severe calcified and narrowed iliac access before EVAR, TEVAR, or BEVAR between November 2020 and June 2022 were retrospectively evaluated. All anatomical iliac characteristics were acquired by multi-planar reconstruction of preoperative computed tomography angiography (CTA). The hostility of the vascular accesses was classified based on Peripheral Arterial Calcium Scoring System (PACSS) and calcified access severity score (CASS), a new score considering both anatomical (calcium grade and length, minimum lumen diameter [MLD], and tortuosity index) and aortic stent-graft (SG/MLD index) parameters. Primary endpoint was technical success defined as successful aortic endograft delivery and deployment without iliac rupture. Freedom from complications and primary patency were additionally analyzed. RESULTS: Twenty-eight iliac axes were treated with IVL (8 bilateral) in 20 patients (mean age 74.5±6.7 years) with a mean follow-up of 26.5±6.2 (range 17-36) months. Ten patients underwent EVAR: 3 TEVAR, and 7 BEVAR procedures. In 14 patients (70%), aneurysm disease was associated with symptomatic aorto-iliac occlusive disease (AIOD), with Rutherford class III to IV. The PACSS was grade IV in 89% of the cases and the CASS (mean 14±2) was grade III to IV in all cases. The stent-graft (SG) outer diameter (5.60±1.65 mm) was significantly larger by 50% than MLD (3.96±1.20 mm), with an SG/MLD index of 1.50±0.51 (p<0.001). Technical success was 100%. No dissection, rupture, or distal embolization occurred. One (3.4%) bail-out stenting was necessary as endoconduit after IVL treatment. One month CTA showed that postoperative luminal gain increased by 93% (p<0.001). An improvement of 2 Rutherford classes occurred in all AIOD patients with a primary patency of 100% at last follow-up. CONCLUSIONS: This study shows the safety and feasibility of IVL as a valuable option to treat narrow and calcified iliac arteries to facilitate endograft delivery. Further studies will be useful to confirm these results. CLINICAL IMPACT: In this article, the use of intravascular iliac artery lithotripsy to facilitate aortic endograft delivery is explored. The presence of iliac severe calcifications still represents a contraindication for aortic endovascular repair. Intravascular lithotripsy increases the feasibility and safety of endovascular aortic procedures, facilitating endograft delivery and reducing the risk of iliac rupture and/or dissections by improving vessel compliance and luminal gain. This novel vessel preparation could be an alternative to "paving and cracking" and/or iliac conduits. This study describes a new score to classify the severity of iliac calcifications, considering anatomical parameters and the profile of aortic endografts delivery system.

Cost Analysis of Target Lesion Revascularisation in Patients With Femoropopliteal In Stent Re-Stenosis or Occlusion: The COSTLY-TLR Study.

OBJECTIVE: To report the cost of target lesion revascularisation procedures (TLR) for femoropopliteal peripheral artery disease (PAD) following stenting, from a healthcare payer's perspective. METHODS: European multicentre study involving consecutive patients requiring femoropopliteal TLR (January 2017 - December 2021). The primary outcome was overall cost (euros) associated with a TLR procedure from presentation to discharge. Exact costs per constituent, clinical characteristics, and early outcomes were reported. RESULTS: This study included 482 TLR procedures (retrospectively, 13 hospitals, six countries): 56% were female, mean age was 75 ± 2 years, 61% were Rutherford class 5 or 6, 67% had Tosaka class 3 disease, and 16% had common femoral or iliac involvement. A total of 52% were hybrid procedures and 6% involved open surgery only. Technical success was 70%, 30 day mortality rate was 1%, and the 30 day major amputation rate was 4%. Most costs were for operating time during the TLR (healthcare professionals' salaries, indirect and estate costs), with a mean of: €21 917 ± €2 110 for all procedures; €23 337 ± €8 920 for open procedures; €12 903 ± €3 108 for endovascular procedures; and €22 806 ± €3 977 for hybrid procedures. In a regression analysis, procedure duration was the main parameter associated with higher overall TLR costs (coefficient, 2.77; standard error, 0.88; p < .001). The mean cost per operating minute of TLR (indirect, estate costs, all salaried staff present included) was €177 and the mean cost per night stay in hospital (outside intensive care unit) was €356. The mean cost per overnight intensive care unit stay (minimum of 8 hours per night) was €1 193. CONCLUSION: The main driver of the considerable peri-procedure costs associated with femoropopliteal TLR was procedure time.

Safety and effectiveness of the phoenix atherectomy device for endovascular treatment of common femoral and popliteal arteries: Results of the EN-MOBILE trial.

Background: This study aimed to assess the peri- and postprocedural outcomes of atherectomy-assisted endovascular treatment of the common femoral (CFA) and popliteal arteries. Methods: Phoenix atherectomy was used for the treatment of 73 and 53 de novo CFA and popliteal artery lesions, respectively, in 122 consecutive patients. Safety endpoints encompassed perforation and peripheral embolization. Postprocedural endpoints included freedom from clinically driven target lesion revascularization (CD-TLR) and clinical success (an improvement of ⩾ 2 Rutherford category [RC]). In addition, 531 patients treated for popliteal artery stenosis or occlusion without atherectomy were used as a comparator group. Results: Procedural success (residual stenosis < 30% after treatment) was 99.2%. The need for bail-out stenting was 2 (2.7%) and 3 (5.7%) in CFA and popliteal artery lesions, respectively. Only one (1.4%) embolization occurred in the CFA, which was treated by catheter aspiration. No perforations occurred. After 1.50 (IQR = 1.17-2.20) years, CD-TLR occurred in seven (9.2%) and six (14.6%) patients with CFA and popliteal artery lesions, respectively, whereas clinical success was achieved in 62 (91.2%) and 31 (75.6%), respectively. Patients treated with atherectomy and DCB in the popliteal artery after matching for baseline RC, lesion calcification, length, and the presence of chronic total occlusion, exhibited higher freedom from CD-TLR compared to the nondebulking group (HR = 3.1; 95% CI = 1.1-8.5, p = 0.03). Conclusion: Atherectomy can be used safely and is associated with low rates of bail-out stenting in CFA and popliteal arteries. CD-TLR and clinical success rates are clinically acceptable. In addition, for the popliteal artery, atherectomy combined with DCB demonstrates lower CD-TLR rates compared to a DCB alone strategy. (German Clinical Trials Register: DRKS00016708).

Intravascular lithotripsy-assisted percutaneous deep vein arterialization for no-option chronic limb-threatening patients and heavily calcified tibial occlusive disease.

PURPOSE: To report the first chronic limb-threatening ischemia (CLTI) patients who underwent an intravascular lithotripsy (IVL)-assisted percutaneous deep vein arterialization (pDVA). CASE REPORT 1: An 81-year-old patient presented with CLTI and a heavily calcified lesion of the popliteal artery and tibioperoneal trunk (TPT), with a distal tibial and foot arch occlusion. The patient underwent IVL and drug-coated balloon angioplasty for the distal popliteal artery and of the TPT to improve the inflow prior to pDVA. The wound situation remained stable without secondary procedure until the patient`s deaths due to complications of urosepsis 3 months later. CASE REPORT 2: A 64-year-old patient with rest pain of the left limb with a single-vessel tibial run-off (peroneal artery) and occluded pedal arch was treated with 3.5 mm IVL followed by a successful pDVA as mentioned above. IVL performed in the proximal posterior tibial artery to optimize the inflow to the circuit and change the compliance of the crossing point from the arterial to the vein system. The patient underwent repeat angioplasty of the plantar vein arch 5 months after the index procedure and thereafter remained asymptomatic during 2 years of follow-up. CONCLUSION: The combined use of IVL and pDVA could improve the patency of the reconstruction with clinical benefits in no-option CTLI patients.

Percutaneous drainage and combined praziquantel-albendazole therapy: a novel approach for the treatment of simple echinococcal liver cysts.

Cystic echinococcosis (CE) is a worldwide helminthic zoonosis causing serious disease in humans. The WHO Informal Working Group on Echinococcosis recommends a stage-specific treatment approach of hepatic CE that facilitates the decision on what therapy option is most appropriate. Percutaneous aspiration, instillation of a scolicide, e.g., ethanol or hypertonic saline, and subsequent re-aspiration (PAIR) have been advocated for treating medium-size unilocular WHO-stage CE1 cysts. PAIR can pose a risk of toxic cholangitis because of spillage of ethanol in the case of a cysto-biliary fistula or of life-threatening hypernatriaemia when hypertonic saline is used. The purpose of our study is to develop an alternative, safe, minimally invasive method to treat CE1 cysts, avoiding the use of toxic topic scolicides.We opt for percutaneous drainage (PD) in four patients: the intrahepatic drainage catheter is placed under CT-fluoroscopy, intracystic fluid is aspirated, and the viability of intracystic echinococcal protoscolices is assessed microscopically. Oral praziquantel (PZQ) is added to albendazole (ABZ) instead of using topical scolicidals.Protoscolices degenerate within 5 to 10 days after PZQ co-medication at a cumulative dosage of 250 to 335 mg/kg, and the cysts collapse. The cysts degenerate, and no sign of spillage nor relapse is observed in the follow-up time of up to 24 months post-intervention.In conclusion, PD combined with oral PZQ under ABZ coverage is preferable to PAIR in patients with unilocular echinococcal cysts.

[Management of Injuries to the Parenchymal Abdominal Organs]. / Management von Verletzungen parenchymatöser Abdominalorgane.

The most common organs affected by abdominal trauma are the spleen and the liver, often in combination. Pancreatic injuries are rare. In the case of blunt abdominal trauma, which is much more common, a clinical and laboratory examination as well as sonography should be performed. In the initial assessment, the circulatory situation must be screened. If there is haemodynamic instability and presentation of free fluid, an emergency laparotomy is indicated. If the situation is stable or stabilised and a pathological sonography is present, it is essential to perform triphasic contrast enhanced computed tomography, which is also mandatory in polytraumatised patients. If a renal injury is suspected, a late venous phase should be attached. In addition to the classification of the injury, attention should be paid to possible vascular injury or active bleeding. In this case, angiography with the possibility of intervention should be performed. Endoscopic treatment is possible for injuries of the pancreatic duct. If the imaging does not reveal any intervention target and a circulation is stable, a conservative approach is possible with continuous monitoring using clinical, laboratory and sonographic controls. Most injuries can be successfully treated by non-operative management (NOM).There are various surgical options for treating the injury, such as local and resecting procedures. There is also the option of "damage control surgery" with acute bleeding control and second look. Complex surgical procedures should be performed at centres. Postoperative complications arise out of elective surgery.In the less common case of penetrating abdominal trauma, the actual extent of the injury cannot be estimated from the visible wound. Here again, the circulatory situation determines the next steps. An emergency laparotomy should be carried out in case of instability. If the condition is stable, further diagnostics should be performed using contrast enhanced computed tomography. If penetration through the peritoneum cannot be clearly excluded, diagnostic laparoscopy should be performed.

Efficacy of a Drug-Eluting Stent Versus Bare Metal Stents for Symptomatic Femoropopliteal Peripheral Artery Disease: Primary Results of the EMINENT Randomized Trial.

BACKGROUND: A clear patency benefit of a drug-eluting stent (DES) over bare metal stents (BMSs) for treating peripheral artery disease of the femoropopliteal segment has not been definitively demonstrated. The EMINENT study (Trial Comparing Eluvia Versus Bare Metal Stent in Treatment of Superficial Femoral and/or Proximal Popliteal Artery) was designed to evaluate the patency of the Eluvia DES (Boston Scientific, Marlborough, MA), a polymer-coated paclitaxel-eluting stent, compared with BMSs for the treatment of femoropopliteal artery lesions. METHODS: EMINENT is a prospective, randomized, controlled, multicenter European study with blinded participants and outcome assessment. Patients with symptomatic peripheral artery disease (Rutherford category 2, 3, or 4) of the native superficial femoral artery or proximal popliteal artery with stenosis ≥70%, vessel diameter of 4 to 6 mm, and total lesion length of 30 to 210 mm were randomly assigned 2:1 to treatment with DES or BMS. The primary effectiveness outcome was primary patency at 12 months, defined as independent core laboratory-assessed duplex ultrasound peak systolic velocity ratio ≤2.4 in the absence of clinically driven target lesion revascularization or surgical bypass of the target lesion. Primary sustained clinical improvement was a secondary outcome defined as a decrease in Rutherford classification of ≥1 categories compared with baseline without a repeat target lesion revascularization. Health-related quality of life and walking function were assessed. RESULTS: A total of 775 patients were randomly assigned to treatment with DES (n=508) or commercially available BMSs (n=267). Baseline clinical, demographic, and lesion characteristics were similar between the study groups. Mean lesion length was 75.6±50.3 and 72.2±47.0 mm in the DES and BMS groups, respectively. The 12-month incidence of primary patency for DES treatment (83.2% [337 of 405]) was significantly greater than for BMS (74.3% [165 of 222]; P<0.01). Incidence of primary sustained clinical improvement was greater among patients treated with the DES than among those who received a BMS (83.0% versus 76.6%; P=0.045). The health-related quality of life dimensions of mobility and pain/discomfort improved for the majority of patients in both groups (for 66.4% and 53.6% of DES-treated and for 64.2% and 58.1% of BMS-treated patients, respectively) but did not differ significantly. At 12 months, no statistical difference was observed in all-cause mortality between patients treated with the DES or BMS (2.7% [13 of 474] versus 1.1% [3 of 263]; relative risk, 2.4 [95% CI, 0.69-8.36]; P=0.15). CONCLUSIONS: By demonstrating superior 1-year primary patency, the results of the EMINENT randomized study support the benefit of using a polymer-based paclitaxel-eluting stent as a first-line stent-based intervention for patients with symptomatic peripheral artery disease attributable to femoropopliteal lesions. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT02921230.

Different endovascular modalities of treatment for isolated atherosclerotic popliteal artery lesions (EMO-POP) registry.

BACKGROUND: The mid-term results after treatment of isolated popliteal lesions have been limited. The aim of the present study was to report the mid-term outcomes after endovascular treatment of isolated atherosclerotic popliteal artery lesions. METHODS: A multicenter (15 hospitals in five countries) retrospective cohort study was performed. Between June 2016 and June 2021, 651 consecutive patients who had been treated for isolated popliteal lesions using endovascular methods exclusively were included in the present study. Six techniques were identified, including plain balloon angioplasty (PTA; n = 286; 43.9%), drug-coated balloon angioplasty (n = 98; 15.1%), stenting with low-chronic outward force (COF) stents (n = 84; 12.9%), stenting with high-COF stents (n = 76; 11.7%), atherectomy alone (n = 17; 2.6%), and directional atherectomy with drug-coated balloons (n = 90; 13.8%). The primary outcomes measures were primary and secondary patency and freedom from clinically driven target lesion revascularization (F-CDTLR). RESULTS: The mean patient age was 74.5 years. Most of the patients (n = 409; 62.9%) had had chronic limb-threatening ischemia. Popliteal occlusion was found in 400 cases (61.4%). High-grade calcification was present in 36.7% of cases. Immediate technical success was 94.8%. The median follow-up was 26 months (range, 6-42 months). The actuarial rate for all patients at 26 months (per outcome measure) was as follows: primary patency, 73.9%; secondary patency, 88%; and F-CDTLR, 76.5%. When comparing PTA vs all other treatments in an adjusted regression analysis, the F-CDTLR was 75.2% for PTA vs 76.5% for all other treatment (hazard ratio, 1.06; 95% confidence interval, 0.75-1.48; P = .46, adjusted regression). The difference in secondary patency also was not statistically significant (85.7% for PTA vs 88%; P = .20). Adjusted Kaplan-Meier analysis revealed that the estimated primary patency was inferior for PTA in pairwise comparisons vs other treatments (P < .001 vs atherectomy; P = .002 vs directional atherectomy with drug-coated balloons; and P = .002 vs low-COF stenting). CONCLUSIONS: The results from our study have shown that endovascular treatment of isolated popliteal lesions is safe and associated with acceptable patency and F-CDTLR in the mid-term.

Two-year target vessel-related outcomes following use of off-the-shelf branched endografts for the treatment of thoracoabdominal aortic aneurysms.

OBJECTIVE: The aim of this study was to assess clinical outcomes and target vessel patency through 2 years following thoracoabdominal aortic aneurysms (TAAA) repair with the off-the-shelf Zenith t-Branch Thoracoabdominal Endovascular Graft (William Cook Europe). METHODS: This post-market observational study was conducted at three European sites with ambispective enrollment from 2012 to 2017. Patients underwent endovascular TAAA repair with the t-Branch graft and bridging stent grafts (BSGs) for the celiac (CA), superior mesenteric (SMA), left renal (LRA), and/or right renal (RRA) arteries. Follow-up was through 2 years, per sites' standard of care. Procedural and 1-year results were reported previously. RESULTS: Eighty patients (mean age, 71.0±7.4 years; 70.0% men) were enrolled; six patients had symptomatic TAAAs, and 15 patients had contained ruptures. Technical success was achieved in 98.8% of patients (79/80). Median follow-up was 22.2 months (interquartile range, 9.2-25.1 months). At 24 months, Kaplan-Meier (KM) freedom from all-cause and aneurysm-related mortality were 78.5% and 98.6%, respectively. Beyond 12 months, 38 adverse events occurred in 20 patients, including two aortic ruptures (one study aneurysm and one non-study aneurysm) and six deaths (none aneurysm-related, as reported by the site). Compared with postprocedure, maximum aneurysm diameter decreased (>5 mm) in 84.6% (44/52), remained unchanged in 3.8% (2/52), and increased (>5 mm) in 11.5% (6/52) of patients with imaging follow-up after 12 months. No conversions to open repair, and no t-Branch graft or other endograft component migration or integrity issues were reported. No loss of patency was reported in the t-Branch or iliac limb grafts throughout the study. Throughout study duration, four patients had five imaging-reported BSG compressions, none of which required secondary intervention. KM freedom from secondary intervention was 76.3% at 24 months. Fourteen target vessel-related secondary interventions were performed, primarily consisting of stent placement for endoleak, stenosis, or occlusion. KM freedom from loss of primary patency was 94.8%, 100%, 91.3%, and 89.3% for the CA, SMA, LRA, and RRA, respectively, at 24 months. KM freedom from loss of secondary patency in the CA, SMA, LRA, and RRA were 96.3%, 100%, 98.2%, and 98.3% at 24 months, respectively. A total of 298 vessels were targeted, of which 12 were occluded over the study period. CONCLUSIONS: Primary and secondary target vessel patency rates through 2 years demonstrated durable repair with the t-Branch graft in patients treated for symptomatic or asymptomatic thoracoabdominal aortic aneurysms.

Five-year outcomes of endosuture aneurysm repair in patients with short neck abdominal aortic aneurysm from the ANCHOR registry.

OBJECTIVE: Hostile aortic neck anatomies such as proximal short necks are known to put patients at an increased risk for type IA endoleaks, migration, and need for reinterventions. The Heli-FX EndoAnchor System was designed to improve seal of aortic stent grafts. Endosuture aneurysm repair (ESAR) using EndoAnchors with the Endurant stent graft has been shown to be safe and effective for the treatment of patients with short necks through one year. This study reports the 5-year patient outcomes of the Aneurysm Treatment using the Heli-FX EndoAnchor System Global Registry (ANCHOR) short neck regulatory cohort. METHODS: The 70 patients from the ANCHOR Registry were cohort submitted to regulators for approval of the Endurant short neck indication. Patients had an infrarenal neck length of ≥ 4 mm and <10 mm. At 5 years, this short neck cohort had clinical and imaging follow-up compliance rates of 85% (28/33) and 70% (23/33), respectively. RESULTS: The short neck cohort had a mean age of 71.3±8.1 years and was 27.1% (19/70) female. Kaplan Meier freedom from all-cause mortality was 68.5 ± 6.2%, freedom from aneurysm-related mortality was 90.1 ± 4.5%, freedom from any endovascular or surgical secondary procedure was 76.9 ± 7.2%, and freedom from rupture was 95.6 ± 3.2%. Eight patients had a total of nine type IA endoleaks detected through 5 years, of which three resolved spontaneously by the next follow-up visit. There were two patients with renal complications who did not undergo reintervention and there were no device migrations reported through 5 years. After 5 years, 68.2% of patients (15/22) had sac regression, 13.6% (3/22) had stable sacs, and 18.2% (4/22) had increased sac diameter as compared with their 1-month measurements. CONCLUSIONS: After ESAR treatment using Heli-FX EndoAnchors with Endurant, the 5-year outcomes of the short neck cohort from the ANCHOR registry had encouraging results with regards to proximal neck-related complications, secondary procedures, and sac regression. This review of ESAR in patients with short proximal necks showed positive outcomes through 5 years although follow-up of a larger cohort is necessary.

Long-term Results of Angulated Versus Hyperangulated Neck in Endovascular Aneurysm Repair With Endurant Endoprosthesis.

PURPOSE: Patients with a hyperangulated (>60°) proximal aortic neck and at high risk of open surgery have been treated with endovascular aortic repair (EVAR). However, long-term outcomes are not well reported. The aim of this study is to compare the technical and clinical success of EVAR in angulated (45°-60°) and hyperangulated (>60°) proximal neck angulation. MATERIALS AND METHODS: The data of all consecutive patients undergoing EVAR treated between November 2007 and February 2020 were collected. A retrospective analysis of this prospective database was performed. The primary measure outcome was technical and clinical success. In addition, we evaluated sack evolution, type IA endoleak, secondary procedures, aneurysm rupture, mortality, aneurysm-related mortality, and migration. RESULTS: In all, 246 of 1353 EVAR patients presented with an angulation of the proximal neck >45°, 130 patients presented with an infrarenal angulation >60°, while 116 patients had an angulation between 45° and 60°. Patients with a hyperangulated infrarenal aortic neck were significantly more often women (8.6% vs 26.9%), older (73.9 vs 76.7 years), and had less often diabetes mellitus (20.7% vs 10.8%). Suprarenal neck angulation and reversed tapered neck were significantly more frequent in the hyperangulated group so that propensity scores were generated using these anatomical parameters to create a matched cohort group. No significant differences in technical (87.9% vs 94.8%) and clinical success (66.4% vs 69.8%) were observed. After a mean clinical follow-up of 58.9 months significantly more secondary procedures were performed in the hyperangulated group (23.3% vs 12.9% p=0.04); however, neck-related secondary procedures were comparable (1.7% vs 6.0%; p=0.09). Also, all-cause and aneurysm-related mortality, sack evolution, type IA endoleak, aneurysm rupture, and migration were comparable for both groups. CONCLUSION: Compared with less angulated proximal aortic neck, hyperangulated neck anatomy did not reduce the technical and clinical success of EVAR but increased the risk of secondary procedures. In patients who are not good candidates for open surgery, EVAR is a reasonable alternative.

Intravascular Lithotripsy and Drug-Coated Balloon Angioplasty for Severely Calcified Femoropopliteal Arterial Disease.

INTRODUCTION: The combination of intravascular lithotripsy (IVL) and drug-coated balloon (DCB) angioplasty for calcified peripheral lesions is associated with promising short-term results. However, data regarding the 12 months performance of this treatment option is missing. This study reports on the outcomes of IVL and DCB angioplasty for calcified femoropopliteal disease. METHODS: Patients treated with IVL and DCB for calcified femoropopliteal lesions between February 2017 and September 2020 were included into this study. The primary outcome measure of this analysis was primary patency. Secondary patency, freedom from target lesion revascularization (TLR) and overall mortality were additionally analyzed. RESULTS: Fifty-five (n = 55) patients and 71 lesions were analyzed. Most patients presented with long-term limb-threatening ischemia (n = 31, 56%), 47% (n = 26) were diabetics, and 66% (n = 36) had long-term kidney disease. The median lesion length was 77 mm (interquartile range: 45-136), and 20% (n = 14) of the lesions were chronic total occlusions (CTOs). Eccentric calcification was found in 23% of the vessels (n = 16), and circumferential calcium (peripheral arterial calcium scoring system [PACSS] Class 3 and 4) was present in 78% (n = 55) of the treated lesions.The technical success after IVL amounted to 87% (n = 62) and the procedural success to 97% (n = 69). A flow-limiting dissection was observed in 2 cases (3%). Both the rates of target lesion perforation and distal embolization were 1% (n = 1). A bail-out scaffold was deployed in 5 lesions (7%). At 12 months the Kaplan-Meier estimate of primary patency was 81%, the freedom from TLR was 92% and the secondary patency 98%. The overall survival amounted to 89%, while the freedom from major amputation to 98%. The presence of eccentric disease, CTOs, or PACSS Class 4 did not increase the risk for loss of patency or TLR. CONCLUSIONS: In this challenging cohort of patients, the use of IVL and DCB for calcified femoropopliteal lesions was associated with promising 12 months outcomes and an excellent safety profile.

Risk Factor Analysis for Crossing Failure in Primary Antegrade Wire-Catheter Approach for Femoropopliteal Chronic Total Occlusions.

INTRODUCTION: Antegrade wire-catheter crossing remains the primary approach for femoropopliteal interventions. Nonetheless, data reporting on crossing failure are limited. Aim of this study is to identify risk factors for antegrade crossing failure in patients with femoropopliteal chronic total occlusions (CTOs). METHODS: This is a single-center, retrospective analysis. Patients with femoropopliteal CTOs treated between May 2018 and February 2020 were included into this study. Primary endpoint of this analysis was primary crossing success defined as successful antegrade crossing without the use of retrograde access, crossing or re-entry devices. The assisted crossing success was additionally analyzed. A logistic regression analysis identified risk factors for failed primary antegrade crossing. RESULTS: Data from 300 patients were analyzed. The majority (n=183, 61%) presented with lifestyle limiting claudication. The mean lesion length was 180 mm [interquartile range (IQR) 100-260 mm], whereas the median CTO length was 100 mm (IQR=50-210 mm). A chronic total occlusion crossing approach based on plaque morphology (CTOP) type I configuration was observed in 9% (n=26) of the lesions, type II in 61% (n=183), type III in 8% (n=25), and type IV in 66 CTOs (n= 66, 22%). Severe calcification based on the Peripheral Arterial Calcium Scoring Scale (PACSS), Peripheral Academic Research Consortium (PARC), and 360° grading systems was identified in 17%, 24%, and 28% of the lesions, respectively. A contralateral femoral access was used in 278 cases (93%). The primary crossing success amounted to 70% (n=210). The use of a re-entry device in 28 patients (9%) or of a combined antegrade-retrograde approach in 11% (n=34) of the cases increased the assisted crossing success to 89% (n=267). The presence of calcification (odds ratio [OR]=4.2, 95% CI=1.7-10.2) or of circumferential calcium (OR=2.5, 95% CI=1.3-4.9), a CTOP class ΙΙΙ or ΙV (OR=1.9, 95% CI=1.4-2.6), a proximal superficial femoral artery (SFA) occlusion (OR=3.5, 95% CI=1.7-7.4) and a CTO at P3 (OR=4.1, 95% CI=1.5-10.8) were associated with an increased risk for antegrade crossing failure. CONCLUSIONS: In this study, chronic total occlusions (CTO) morphology, calcification burden, and lesion's location were identified as independent risk factors for failed antegrade crossing. Nonetheless, the use of alternative crossing strategies significantly increased the overall crossing success.

Intravascular Lithotripsy and Drug-Coated Balloon Angioplasty for Severely Calcified Common Femoral Artery Atherosclerotic Disease.

OBJECTIVES: Intravascular lithotripsy (IVL) followed by drug-coated balloon (DCB) angioplasty might be a valuable alternative to surgery for calcified common femoral artery (CFA) atherosclerotic disease. Nonetheless, the 12 months performance of this treatment strategy remains unknown. This study reports on the 12 months outcomes of IVL with adjunctive DCB angioplasty for calcified CFA lesions. METHODS: This is a retrospective single-center, single-arm study. Consecutive patients treated by IVL and DCB for calcified CFA disease between February 2017 and September 2020 were evaluated. The primary measure outcome of this analysis was primary patency. Procedural technical success (<30% stenosis), freedom from target lesion revascularization (TLR), secondary patency, and overall mortality were additionally analyzed. RESULTS: Thirty-three (n=33) patients were included in this study. The majority presented with lifestyle limiting claudication (n=20, 61%), 52% (n=17) of the patients had chronic kidney disease (CKD) and 33% (n=11) had diabetes. The procedural technical success was 97% (n=32). A flow-limiting dissection post IVL was observed in 2 patients (6%) and a peripheral embolization in a single patient (3%), while the bail-out stenting rate amounted to 12% (n=4). No perforation was observed. The median length of hospital stay was 2 days (interquartile range 2-3). At 12 months, the primary patency was 72%. The freedom from TLR and the secondary patency rates were 94% and 88%, respectively. The 12-month survival amounted to 100% and 75% (n=25) of the patients were asymptomatic or presented with mild claudication. The presence of chronic limb-threatening ischemia (CLTI) (hazard ratio [HR], 0.92; confidence interval (CI); 0.18-4.8, p=0.7) or CKD (HR, 1.30; 95% CI, 0.29-5.8; p=0.72), as well as the use of a 7 mm IVL catheter (HR, 0.59; 95% CI, 0.13-2.63; p=0.49) or of high-dose DCB (HR, 0.68; 95% CI, 0.13-3.53; p=0.65) did not influence the primary patency. CONCLUSIONS: In this study, the combination of IVL and DCB angioplasty for calcified CFA disease was associated with low risk for periprocedural complications, acceptable 12 months clinical outcomes, and low rates of reinterventions. CLINICAL IMPACT: Intravascular lithotripsy in combination with DCB angioplasty can be an alternative to surgery in highly selected patients with CFA atherosclerotic disease. In this Cohort the combination therapy lead to acceptable clinical results and low reintervention rates at 12 months.

Outcomes After Open Surgical, Hybrid, and Endovascular Revascularization for Acute Limb Ischemia.

PURPOSE: To report the performance of surgical treatment (ST), hybrid treatment (HT), and endovascular treatment (ET) for patients with acute limb ischemia (ALI). METHODS: This is a retrospective, comparative study of all consecutive patients with ALI treated in 2 tertiary centers between April 2010 and April 2020. Amputation and/or death (amputation-free survival; AFS) was the primary composite endpoint. Mortality, major amputation, and reintervention during follow-up were additionally analyzed. Proportional hazards modeling was used to identify confounders, results are presented as hazard ratio (HR) and 95% confidence intervals (CIs). RESULTS: In total, 395 patients (mean age=71.1±13.6 years; 51.1% female) were treated during the study period. Surgical treatment was preferred in 150 patients (38%), while 98 were treated by HT (24.8%) and 147 by ET (37.2%). Rutherford class IIa was the most common clinical presentation in the ET group (50.3%), whereas Rutherford IIb was most common in the ST (54%) and HT (48%) groups (p<0.001). Significantly, more patients presented with a de novo lesion in the ST and HT groups (79.3% and 64.3%, respectively) compared with ET (53.7%; p<0.001). Median follow-up was 20 months (range=0-111 months). In the multivariate analysis, ET showed significantly better AFS during follow-up compared with ST (HR=1.89, 95% CI=1.2-2.9, p<0.001) and HT (HR=1.73, 95% CI=1.1-3.1, p<0.001). Mortality during follow-up was also significantly lower after ET compared with ST (HR=2.21, 95% CI=1.31-3.74, p=0.003) and HT (HR=2.04, 95% CI=1.17-3.56, p=0.012). Endovascular treatment was associated with lower amputation rate compared with ST (HR=2.27, 95% CI=1.19-4.35, p=0.013) but was comparable with HT (HR=2.00, 95% CI=0.98-4.06, p=0.055). Reintervention rates did not differ significantly between the groups (ET vs ST: HR=1.52, 95% CI=0.99-2.31, p=0.053; ET vs HT: HR=1.3, 95% CI=0.81-2.07, p=0.27). CONCLUSION: Endovascular treatment for ALI was associated with improved AFS and comparable reintervention rates compared with open surgical and hybrid therapy. CLINICAL IMPACT: Treatment of acute lower limb ischemia remains a challenge for clinicians with high morbidity and mortality rates. Endovascular revascularization is considered first line treatment for many and hybrid treatments are becoming more common, however data is limited to either old trials, small series or with short follow-up. We present herein our 10-year experience with all available devices and techniques for open surgical, endovascular and hybrid acute limb ischemia treatments and compare their outcomes.

Three-Year Safety and Efficacy of the INCRAFT Endograft for Treatment of Abdominal Aortic Aneurysms: Results of the INSIGHT Study.

PURPOSE: Preliminary results of the INSIGHT study showed that the low-profile INCRAFT Abdominal Aortic Aneurysm (AAA) Stent-Graft System was safe and effective in the endovascular aneurysm repair (EVAR). This study aimed to assess the durability and the midterm effectiveness of EVAR using the INCRAFT System in the framework of a multicenter, prospective, open-label, post-approval study. MATERIALS AND METHODS: Between 2015 and 2016, 150 subjects from 23 European centers treated with the INCRAFT System for an infrarenal AAA were included. Clinical and radiologic data were prospectively collected and analyzed using protocol-specified, monitored follow-up clinic visits at 1, 6, and 12 months post-implantation and annually after that. The clinical success at 3 years was determined. Freedom from overall and aneurysm-related mortality, type I endoleak, secondary interventions, and aneurysm sac enlargement through 3 years were evaluated. Kaplan-Meier estimates were used for late outcomes. An independent clinical events committee reviewed all events. The CT (computed tomography) scans through 1 year were reviewed by an independent core laboratory. RESULTS: The primary clinical success rate at 3 years was 84.0% (126/150). There were no aneurysm-related deaths, endograft migration, or aneurysm-related ruptures through 3 years. Stent fracture was detected in 2 subjects (1.3%) without clinical sequelae. Over 3 years, freedom from overall mortality was 89.4%, freedom from secondary interventions was 80%, and freedom from aneurysm sac enlargement was 96.5%. The 3-year freedom from type IA and IB endoleaks was 93.3% and 98.6%, respectively. CONCLUSIONS.: In a multicenter real-world study setting, the use of a low-profile INCRAFT device for AAA is associated with sustained clinical success and low rates of reinterventions through 3 years. CLINICAL IMPACT: Low-profile endografts have broadened the spectrum of patients with anatomic suitability for endovascular repair of abdominal aortic aneurysms (AAA). However, questions remain regarding the durability of the repair. The INSIGHT study evaluated the use of the INCRAFT System in routine real-world clinical practice, including patients with complex anatomies. The treatment was safe and effective. The results showed sustained clinical success over 3 years, with no aneurysm-related deaths or ruptures, and a high rate of intervention-free survival at 3 years. Despite the low-profile design of the endograft, the midterm results demonstrate the durability of AAA repair using the INCRAFT System.ClinicalTrials.gov Identifier: NCT02477111.

Endovascular Versus Surgical Treatment for All Comer Patients With Prosthetic Bypass Graft Occlusion: The Multicentre ENSUPRO Study.

OBJECTIVE: Bypass surgery plays a key role in complex lower limb lesions. However, there is a lack of evidence regarding the management of symptomatic prosthetic bypass graft (PBG) occlusion. This study aimed to report outcomes following open, hybrid, or endovascular management of patients presenting with symptomatic PBG occlusion. METHODS: A multicentre, retrospective cohort study was conducted, including patients presenting with PBG occlusion between January 2014 and December 2021 from 18 centres. It assessed the comparative value of treatment strategies, including (1) recanalisation of native vessels, (2) endovascular treatment of the failed PBG, (3) hybrid treatment, and (4) open surgery. The primary outcome measure was amputation free survival (AFS, time to major amputation and or death), whereas all cause mortality, major amputation, PBG re-occlusion, target lesion revascularisation (TLR), and Rutherford category (RC) improvement during follow up were considered as secondary endpoints. RESULTS: Of 260 patients with occluded PBGs, 108 (41.5%) were treated endovascularly (24 [22.2%] by recanalisation of native vessels and 84 [77.7%] by PBG re-opening), 57 (21.9%) underwent hybrid revascularisation, and 58 (22.3%) had surgery. In addition, 27 (10.4%) were treated conservatively and 10 (3.8%) received systemic thrombolysis. With a median follow up of 1.4 (0.6 - 3.0) years, AFS was 95.5%, 76.4%, 45.5%, and 37.1%, respectively in Groups 1 - 4 (p = .007). Older age and non-endovascular treatment (HR 1.05 and 1.70; p < .01 for both) were independent predictors of poor AFS. Endovascular treatment was associated with lower rates of major amputation (p = .04), PBG re-occlusion (p < .001), and TLR (p = .037), and higher RC improvements (p < .001), whereas all cause mortality was comparable between treatment groups (p = .21). CONCLUSION: Endovascular treatment is associated with higher rates of AFS and RC improvement and lower rates of PBG re-occlusion and TLR in patients with PBG occlusion.

Editor's Choice - RANDOMisation Screening for Drug coated or Drug Eluting Device Randomised Trials Among Patients Undergoing Endovascular FemorOPopliteal Procedures (RANDOM-STOP study).

OBJECTIVE: The aim was to assess the proportion of patients undergoing endovascular therapy for femoropopliteal arterial disease (FP) who would be eligible to take part in seven major randomised controlled trials (RCTs) that investigated the efficacy of some of the currently available paclitaxel based (PTX) devices used in this clinical context. Various RCTs have shown a potential clinical benefit from the use of paclitaxel in FP endovascular therapy. Nonetheless, patients enrolled were highly selected and the generalisability of these findings in pragmatic cohorts is unclear. METHODS: Between 1 January and 31 December 2021, all consecutive patients who underwent endovascular procedures for symptomatic FP disease in 16 European centres were retrospectively screened and included in this analysis. The primary outcome measure was individual patient eligibility for inclusion into at least one of the seven RCTs. The reasons for exclusion (clinical and or radiological) as well as in hospital death and morbidity were also reported. RESULTS: A total of 1 567 consecutive patients (959 male, 61%), corresponding to 1 567 lower limbs, were included. Most patients (1 009 patients, 64.39%) were treated for chronic limb threatening ischaemia (CLTI). A total 1 280 patients (81.68%) were not eligible for inclusion in any of the evaluated RCTs. Of them, 741 (47.28%) were excluded for clinical and 1 125 (71.79%) for radiological reasons. CONCLUSION: The analysed RCTs assessing the efficacy or effectiveness of PTX based endovascular therapies do not seem representative of the patient population with FP disease receiving endovascular therapy in routine clinical practice.

Use of Secondary Iliac Branch Devices after Previous Endovascular Abdominal and Thoraco-Abdominal Aortic Aneurysm Repair.

OBJECTIVE: To assess the safety and effectiveness of iliac branch devices (IBDs), as secondary procedure, for the treatment of type Ib endoleak or evolution of iliac artery disease after prior endovascular aortic repair (EVAR) for thoraco-abdominal (TAAAs) or abdominal aortic aneurysms (AAAs). METHODS: A multicentre observational study of three European centres. The study included 75 patients (age 71 ± 9 years, 96% men) with previous EVAR (n = 64, 85%) or fenestrated or branched (FB) EVAR (n = 11, 15%). Overall, 88 IBDs were implanted to treat aneurysmal iliac artery evolution in 40 (53%) and type Ib endoleak in 35 (47%) cases, respectively. Thirteen (17%) patients received bilateral IBDs. Internal iliac artery (IIA) catheterisation was done through a transaxillary access (n = 82, 93%) or up and over (n = 6, 7%) technique. The primary endpoint was technical success. Secondary endpoints were 30 day major adverse event, early and long term freedom from re-intervention and target vessel instability. RESULTS: All procedures were technically successful (100%). During hospitalisation, there were four (5%) major adverse events and three (4%) early re-interventions, but no death, stroke, or damage to previous endografts. The median follow up was 47 (interquartile range 42) months, and the five year survival rate was 78 ± 6% with no aortic related death. Cox's regression analysis showed pre-operative renal function impairment (hazard ratio [HR] 3.4; 95% confidence interval [CI] 1.1 - 10.1; p = .033), and primary TAAA repair (HR 6.1; 95% CI 1.6-22.3; p = .006) as independent factors for long term mortality. Freedom from re-interventions was 85 ± 4% at five years with 11 (12%) cases (five endoleaks, four IBD thromboses, two stenoses). IIA instability was reported in three (3%) limbs and freedom from IIA instability was 95 ± 3% after 60 months. CONCLUSION: Secondary IBD after EVAR is a safe and effective procedure with high technical success and low complication rates. The technique of choice to revascularise the IIA seems not to affect early and follow up results. Long term durability of IBD repair is acceptable with low rates of IIA re-intervention.