Influence of Perioperative Factors on Patency After Endovascular and Hybrid Treatments of TASC II D Aortoiliac Occlusive Lesions.

BACKGROUND: Treatment of Trans-Atlantic Inter-Society Consensus (TASC) II D aortoiliac occlusive disease (AIOD D) remains a controversial topic. Although current recommendations support conventional surgical treatment, several recent studies have reported promising results with endovascular and hybrid strategies. The purpose of this work was to describe the outcomes of endovascular and hybrid management of AIOD D and to investigate the influence of perioperative factors on patency. METHODS: This was a retrospective single-center study covering the period from 2016 to 2021. The primary end point was primary patency at 12 months. Secondary endpoints included technical success rate, 30-day mortality, early major complication rate, primary assisted and secondary patency at 12 months, and primary patency at 24 months. After descriptive statistical analysis, a survival analysis was conducted using the Kaplan-Meier method. Eighteen perioperative factors potentially associated with primary patency were studied by univariate and multivariate analysis adjusted by a Cox regression model. RESULTS: In all, 82 patients (112 limbs) had undergone an attempt at endovascular (n = 55, 67%) or hybrid (n = 27, 33%) treatment for AIOD D over the study period. The technical success rate was 99%. The 30-day mortality rate was 3%. The early major complication rate was 11%. The primary patency rates at 12 and 24 months were 87.9% [80.3; 96.3] and 77% [66.3; 89.3], respectively. The primary assisted and secondary patency rates at 12 months were 92.6% [86.3; 99.2] and 96% [91.4; 100]. Among the perioperative factors studied, the heavily calcified nature of the target lesions was the only variable significantly associated with primary patency loss in the multivariate analysis (P = 0.021). CONCLUSION: Although the results of endovascular and hybrid treatment of AOID D are acceptable, future studies should focus on improving patency rates in heavily calcified lesions. Specific tools of endovascular preparation (intravascular lithotripsy, atherectomy) may represent interesting ways of research.

Mechanical Comparison between Fenestrated Endograft and Physician-Made Fenestrations.

INTRODUCTION: A fenestrated endograft (FE) is the first-line endovascular option for juxta and pararenal abdominal aortic aneurysms. A physician-modified stent-graft (PMSG) and laser in situ fenestration (LISF) have emerged to circumvent manufacturing delays, anatomic standards, and the procedure's cost raised by FE. The objective was to compare different fenestrations from a mechanical point of view. METHODS: In total, five Zenith Cook fenestrations (Cook Medical, Bloomington, IN, USA) and five Anaconda fenestrations (Terumo Company, Inchinnan, Scotland, UK) were included in this study. Laser ISF and PMSG were created on a Cook TX2 polyethylene terephthalate (PET) cover material (Cook Medical, Bloomington, IN, USA). In total, five LISFs and fifty-five PMSG were created. All fenestrations included reached an 8 mm diameter. Radial extension tests were then performed to identify differences in the mechanical behavior between the fenestration designs. The branch pull-out force was measured to test the stability of assembling with a calibrated 8 mm branch. Fatigue tests were performed on the devices to assess the long-term outcomes of the endograft with an oversized 9 mm branch. RESULTS: The results revealed that at over 2 mm of oversizing, the highest average radial strength was 33.4 ± 6.9 N for the Zenith Cook fenestration. The radial strength was higher with the custom-made fenestrations, including both Zenith Cook and Anaconda fenestrations (9.5 ± 4.7 N and 4.49 ± 0.28 N). The comparison between LISF and double loop PMSG highlighted a higher strength value compared with LISF (3.96 N ± 1.86 vs. 2.7 N ± 0.82; p= 0.018). The diameter of the fenestrations varied between 8 and 9 mm. As the pin caliber inserted in the fenestration was 9 mm, one could consider that all fenestrations underwent an "elastic recoil" after cycling. The largest elastic recoil was observed in the non-reinforced/OC fenestrations (40%). A 10% elastic recoil was observed with LISF. CONCLUSION: In terms of mechanical behavior, the custom-made fenestration produced the highest results in terms of radial and branch pull-out strength. Both PMSG and LISF could be improved with the standardization of the fenestration creation protocol.

Single Primary Retrograde Access to Treat Femoro-Popliteal Occlusive Lesions.

INTRODUCTION: The retrograde puncture of a distal artery is considered a bailout procedure in case of anterograde approach failure for peripheral artery disease (PAD) treatment. A single primary retrograde access has been suggested as an efficient and safe option. As scant data are available, we present our results using this approach. MATERIAL AND METHODS: Between August 2019 and October 2022, we performed this technique in selected patients with femoro-popliteal PAD. Chronic total occlusions (CTOs) were selected on the basis of the CTOP classification. An ultrasound-guided retrograde puncture of a tibial artery at the ankle level was performed, followed by the preferential use of 4F materials. Hemostasis of the puncture site was obtained using manual compression. Postoperative duplex scan examination systematically included an evaluation of the punctured artery. Demographics, intraoperative, and follow-up data were collected retrospectively. The results are expressed as means with standard deviations and numbers with percentages when appropriate. RESULTS: In total, 55 procedures were performed in 46 patients (9 bilateral). Of these, 57% (N=26) were considered at risk for femoral puncture (obesity, history of groin surgery, challenging crossover approach) and 54% (N=25) presented with critical limb-threatening ischemia (CLTI). The TASC-II femoro-popliteal classification was generally B (60%) and also C (33%) or D (7%). Mean lesion length was 105.6±49.4 mm and 65% were CTOs. Most patients were operated in an outpatient setting (N=25; 54%) under potentialized local anesthesia (N=41, 89%). The punctured site was the posterior tibial artery in 73% (N=40). The procedure time was 65.1±25.7 minutes, and the fluoroscopy time was 10.7±8.5 minutes. The technical success rate was 100%. There were no intraoperative complications. All patients could walk the same day. One CLTI patient presented an erysipelas related to the puncture in postoperative period. At 30 days, the primary patency of the treated and the punctured arteries were 98% and 100%, respectively. CONCLUSION: A single primary retrograde access can be used safely to treat femoro-popliteal PAD. It represents a valuable alternative to the femoral puncture and allows fast ambulation. Prospective and long-term studies on larger populations are necessary to confirm our results. CLINICAL IMPACT: This study demonstrates that a single primary retrograde access can be used safely without damaging the punctured artery to treat femoro-popliteal lesions, especially in claudicant patients. Chronic total occlusions can be treated successfully using this technique. This approach represents a valuable alternative to the femoral puncture and allows fast ambulation without risk of major bleeding.

Mechanical Performance Assessment of Physician Modified Aortic Stent Graft.

OBJECTIVE: This study aimed to compare various fenestration configurations of physician modified aortic stent grafts in order to identify which design parameters have a significant influence on the mechanical behaviour of the fenestration. METHODS: the fenestration configurations were considered according to different manufacturing parameters: cutting technique, fenestration reinforcement, suture material, reinforcement loop design, and number of suture points. The performance of the graft/bridging stent assembly was assessed at various levels: (1) branch pull out force; (2) fenestration enlargement and rupture strength; (3) balloon angioplasty resistance; and (4) behaviour under cyclic fatigue. RESULTS: Sixty manual fenestrations were created. The tests performed on the fenestrations had several main findings. First, reinforcement increased the radial force on the branch, which increased the pull out force; this may limit migration of the bridging stent in vivo. The phenomenon was amplified with a snare reinforced fenestration, which seemed to be the most efficient. Moreover, increasing the number of suture passes also appeared to increase the branch extraction force securing the assembly. The enlargement tests showed that non-reinforced fenestrations had the weakest radial strength. This was confirmed with the balloon angioplasty test, which showed that these latter specimens undergo the most significant textile degradation. After fatigue tests, all fenestrations were larger, showing that elastic recoil was incomplete in all samples. The largest recoil was observed in the non-reinforced ophthalmological cautery (OC) fenestrations (40%). Regarding the behaviour of the samples up to rupture, all samples behaved in a similar way; however, the double loop fenestration strength level was the highest. CONCLUSION: This study demonstrated that the snare double loop reinforcement has an advantage regarding durability of the graft branch assembly. Moreover, non-reinforced fenestrations show signs of weakness and lack of stability, which questions the in situ or laser fenestration procedures.

Readmissions Following Arteriovenous Access Creation for Haemodialysis in a French National Database.

OBJECTIVE: There is a lack of large real world data on arteriovenous (AV) access results. This study aimed to describe the required hospital care during the first year following creation of AV access. METHODS: Data from all adult patients who underwent creation of AV access performed in 2017 in a public or private facility were collected through the French national hospitalisation database. Patients were classified into two groups ("de novo" and "secondary") according to their history of prior AV access creation. The primary outcome was the proportion of patients with at least one hospital readmission related to the AV access recorded during the first 12 post-operative months. RESULTS: In 2017, 10 476 adult patients underwent AV access creation in France, including 8 690 (83%) de novo creations. An AV fistula was created for 92% of the patients (95% de novo vs. 78% secondary; p < .001). During the first 12 post-operative months, 6 591 (63%) patients recorded at least one related readmission (68% secondary vs. 62% de novo; p < .001). A total of 5 557 (53%) recorded a readmission for surgical/interventional procedure and 2 852 (27%) were observed with a readmission for medical complications. The mean (± standard deviation) number of related readmissions at 12 months was 1.4 ± 1.6 per patient (1.7 ± 1.9 secondary vs. 1.3 ± 1.5 de novo; p < .001). Patients with an AV graft were more frequently readmitted than those with an AV fistula (1.8 ± 2 vs. 1.3 ± 1.5 readmission; p < .001). CONCLUSION: This study highlights the high frequency of readmissions during the first 12 months following creation of AV access, particularly in patients who had already undergone creation of a previous AV access or had an AV graft implanted. Further research should focus on tailoring AV access strategies to improve patient quality of life and decrease the healthcare cost burden.

Extra Anatomic Aorto-Iliac Revascularization Using Descending Thoracic Aorta to Bifemoral Bypass in Selected Cases.

BACKGROUND: When best medical treatment fails to relieve symptoms of aorto-iliac occlusive disease, endovascular treatment or conventional open surgery are the remaining options depending on lesions and patients' characteristics. However, in certain situations both endovascular tools and abdominal aorta to bifemoral bypass (TFB) are not an option and the use of the descending thoracic aorta may be considered as an inflow site for revascularization. METHODS: This work is a single-center retrospective study. Between 2008 and 2020, 27 patients were identified who were treated with descending thoracic aorta to TFB for severe aorto-iliac occlusive disease. Primary end point was 30-day postoperative mortality and major cardiovascular events. Secondary end points were primary patency, secondary patency, and all-cause mortality. RESULTS: The mean age of patients was 68 years and the majority (88.9%) presented with severe claudication. Eighteen patients underwent isolated TFB and 9 had TFB and concomitant visceral vessel revascularization. The mean length of stay was 14 days and there was no postoperative death. Complications, mainly pulmonary, occurred in 29.8% of the cases. After a mean of 26 months of follow-up, survival rate was 95% and primary and secondary patency rates were 92.6% and 96.3%, respectively. Mean Rutherford index shifted from 3.1 to 1.2 (P < 0.001). CONCLUSIONS: TFB is an invasive procedure which provides high clinical improvement and patency rates. This procedure should remain part of the vascular surgeon portfolio.

Single Stem Visceral Debranching for Complex Aortic Disease.

Objective: The treatment of complex aortic disease has been described with various retrograde visceral bypass techniques. An original technique with a single stem retrograde visceral graft (SSRVG) is presented. Methods: This was a single centre retrospective study including 16 patients between 2015 and 2019. Patients were treated for aortic dissection (AD; type A and acute or chronic type B), thoraco-abdominal aortic aneurysms (TAAAs), and visceral occlusive disease. Surgery consisted of visceral vessel debranching from the native infrarenal aorta or from an aortic graft. In the case of AD, surgical fenestration was performed. Additional thoracic endovascular aneurysm repair (TEVAR) completed the treatment when indicated, during the same procedure or later. Patient outcomes and reconstruction patency were studied. Results: The mean patient age was 64 years (median 68 ± 12.6). Ten (62%) patients were treated for AD, three (19%) for TAAA, and three (19%) for occlusive disease. Sixty-nine target vessels were debranched with this SSRVG technique. Aortic surgical fenestration was performed in eight cases and TEVAR in four. During their hospital stay, three (19%) TAAA patients died, seven cases of renal insufficiency (44%), four cases of pneumonia (25%), and three colonic ischaemia cases (19%) were noted. After a mean follow up of 21 months, no other deaths occurred. All vessels (except two inferior mesenteric arteries) were patent and no endoleak was noted. Conclusion: The SSRVG technique can be offered in various complex aortic diseases. The use of a single graft is feasible and reduces the volume of multiple branch assembly in the retroperitoneal space. The observed patency rate is high.

Hybrid Management for Anterior Nutcracker Syndrome: Left Renal Vein Stenting with Laparoscopic Stent Exofixation.

INTRODUCTION: Left renal vein stenting (LRVS) for the treatment of anterior nutcracker syndrome (NCS) has been associated with a significant risk of stent migration into the inferior vena cava or right ventricle. SURGICAL TECHNIQUE: A hybrid technique is reported for the treatment of NCS to prevent stent migration. The first part of the procedure consists of LRVS at the level of the aortomesenteric compression. The second part consists of laparoscopic stent exofixation through a transperitoneal direct approach. The left renal vein is exposed in order to visualise the stent meshes through the venous wall. Stent exofixation in performed with a simple transfixing polypropylene stitch, reinforced with a Teflon pledget. DISCUSSION: The hybrid treatment of anterior NCS combining laparoscopic stent exofixation with left renal vein stenting is a simple and low morbidity technique. Further follow up data are needed to evaluate its potential benefit in reducing the risk of left renal vein stent migration.

Endovascular Repair of Narrow Distal Aortas Using an In Situ Fenestration Technique.

PURPOSE: To demonstrate that in situ fenestration (ISF) of an aorto-uni-iliac endograft to treat aortoiliac disease with narrow distal aorta (NDA) vessels is effective and safe. MATERIALS AND METHODS: Data for all patients treated by use of ISF between August 2014 and December 2019 were retrospectively analyzed. The series included 27 patients, aged 70 years ± standard error (SE) 11. The pathologies treated included aortoiliac occlusive disease (n = 16), asymptomatic abdominal aortic aneurysm (n = 8), and a ruptured abdominal aortic aneurysm (n = 3). The technique consisted of deploying an aorto-uni-iliac graft, which was converted into a bifurcated repair through contralateral iliac ISF. The inclusion criteria encompassed the presence of an abdominal aortic aneurysm (diameter of >50 mm, rapid growth, ruptured or symptomatic) associated with NDA or the presence of severe aortoiliac occlusive disease with NDA. NDA is defined as an aortic diameter of <16 mm. RESULTS: The mean aortic bifurcation diameter was 11.9 mm ± SE 1.5. In total, 55% of the fenestrated endografts were performed with a multifilament polyester endograft and 45% with expanded polytetrafluoroethylene endograft. Technical success was 100%. Fluoroscopy time was 28 minutes ± SE 12, and 94 mL ± SE 43 of iodinated contrast medium was used. In the postoperative course, a single minor retroperitoneal hematoma was identified. The mean hospital stay was 5 days ± SE 3. At the mean follow-up of 26 months ± SE 22, overall primary patency was 94% and no endoleak was observed at the ISF site. CONCLUSIONS: The ISF technique is safe and effective in the treatment of aortoiliac disease with NDA. Comparisons with alternative techniques are needed to determine the long-term durability.

Conversion From an Outpatient to an Inpatient Setting After an Endovascular Treatment for Lower Extremity Artery Disease.

BACKGROUND: Outpatient endovascular treatment (EVT) for lower extremity artery disease (LEAD) is increasing. Some patients will, nonetheless, unexpectedly stay hospitalized for the night after the procedure. The purpose of this study was to identify the factors associated with a conversion from an outpatient setting (OS) to an inpatient setting (IS). METHODS: From April 2017 to August 2019, we performed 745 EVT for LEAD. Patients scheduled for a same-day discharge procedure were retrospectively analyzed. The factors potentially associated with a conversion to an IS were assessed. Results are expressed as odds ratio (OR) with 95% confidence intervals. RESULTS: Among the 198 (26.6%) patients scheduled for outpatient EVT, mean age was 70.8±14.1 years old, 34.3% had an ASA score≥3 and 38.4% presented a chronic limb-threatening ischemia. Twenty-eight patients (14.1%) were converted from an OS to IS. Univariate analysis found that Rutherford stage≥4 (OR = 5.09 [2.11-12.27], P < 0.001), high blood pressure (OR = 3.19 [1.06-9.63], P = 0.040), ASA score≥3 (OR = 3.61 [1.58-8.24], P = 0.002), duration of procedure ≥90 min (OR = 2.36, [1.03-5.39], P = 0.042), anterograde puncture (OR = 2.94, [1.30-6.66], P = 0.009), arrival in the operating room ≥12:00 (OR = 13.05, [5.29-32.17], P < 0.001) and general anesthesia (OR = 3.89, [1.20-12.62], P = 0.024) were associated with a conversion. The multivariate analysis revealed that an arrival in the operative room ≥12:00 (OR = 11.71, [3.85-35.60], P < 0.001) and general anesthesia (OR = 6.76, [1.28-35.82], P = 0.009) were independent factors associated with a conversion. CONCLUSION: Arrival in the operative room after 12:00 and general anesthesia represent two independent correctible factors associated with the risk of OS failure. No factor directly related to comorbidities or the LEAD severity was identified.

Mechanical Behaviour of Fenestrations in Current Aortic Endografts.

OBJECTIVE: The aim of this study was to assess the mechanical characteristics of current commercially available fenestrated endografts (FE). The performance of the fenestrations according to the design were compared as the relationship between a bridging covered stent graft (CSG) and the fenestration. METHODS: A total of 21 Zenith (Cook Medical, Bloomington, IN, USA) and 17 Anaconda (Terumo Company, Inchinnan, UK) fenestrations were studied. Radial extension tests were performed, inserting two half cylinders spaced up to 2 mm in a 7 mm diameter fenestration from each device. Branch pull out force was measured to test the stability of the assembly with a calibrated 8 mm branch and two CSGs: Advanta V12 (Atrium Medical; Hudson, NH, USA) and BeGraft Peripheral Stent Graft (Bentley InnoMed GmbH, Hechingen, Germany). A branch was inserted in both the 7 mm diameter fenestrations and in a control 7 mm fenestration. Fatigue tests were performed on the devices to assess long term outcomes of the endograft. RESULTS: Over a 2 mm vertical displacement, the resulting loading curves look similar for both devices. The force value level was 33.4 ± 6.9 N for the Cook fenestration and 54.45 ± 18 N for the Anaconda fenestration (p = .001). With respect to an 8 mm calibrated branch, the required extraction strength from the fenestration was statistically significantly greater with the Anaconda device (9.5 ± 4.7 N vs. 4.49 ± 0.28 N; p = .001). The required strength to extract the V12 CSG from a control cylindered shape was statistically significantly higher than for the BeGraft CSG (6.75 ± 2.86 N vs. 1.83 ± 0.67 N; p = .003). The surface area of the fenestration of the Cook device was increased with cycling (7 200 cycles) compared with the Anaconda device (15.5% vs. 6.5% hole surface area increase). CONCLUSION: The mechanical performance of the fenestration can be fine tuned by considering its design. A CSG optimising the performance of the fenestration and the CGS-fenestration interface could reduce the risk of leakage in clinical practice.

Degradation Phenomena on "Homemade" Explanted Aortic Textile Endografts.

OBJECTIVE: In the 1990s, the concept of "homemade" endografts (EGs) using commercially available materials was proposed in clinical practice for endovascular abdominal aortic repair (EVAR). The aim of this study was to analyse the ageing phenomena of these EGs in light of explant analyses. METHODS: The study focused on five explanted homemade EGs collected from 2012 to 2014. The explants were assessed in accordance with the ISO 9001/13485 certified standard protocol, which included naked eye evaluation, organic remnant cleaning, and microscopic and endoscopic examinations and analysis (magnification range from 20% to 200%). The observations report followed a classification based on 12 features assessing the fabric cover, the stitch filament, and the stents. RESULTS: The reasons for explantation were type 1 endoleak in three cases and aneurysm sac growth in two. The implantation duration ranged from 56 to 202 months. Sixty three per cent of the fabric surface lesions (holes and tears) were related to abrasion between the fabric and the stents. Up to 33% of the knots used to connect adjacent stents were broken on one EG. Other defects including running suture rupture and stent corrosion were also observed. The overall hole cumulated surface ranged from 0.377 mm2 (56 month of implantation) up to 3.21 mm2 (78 month of implantation). CONCLUSION: In this study, various ageing phenomena on homemade textile EGs were identified and classified. The main damaging mechanisms were related to abrasion stress leading to tears and holes in the fabric, stitch ruptures, and detachment of stent segments responsible for serious EG deformations and further degradation.

Endovascular Treatment of Long Femoropopliteal Lesions with Contiguous Bare Metal Stents.

OBJECTIVES: Recent controversies on the use of drug coated/eluting devices in the arteries of the lower extremities renewed the focus on the evaluation of more conventional techniques. The results of the stenting of short and/or intermediate femoro-popliteal lesions are well known, but little data relate to the endovascular treatment of long femoro-popliteal lesions with contiguous bare metal stents (ETLFBS). The objective of this study was to report our results of ETLFBS. MATERIAL AND METHODS: Between January 2014 and December 2017, 1233 patients had an infrainguinal angioplasty in our center. The files of patients treated for femoropopliteal lesions longer than 250 mm using extensive stenting with contiguous bare metal stents were reviewed and analyzed. The primary outcome was the 12-month primary patency, defined by the absence of restenosis (≥50%) and/or reintervention on the target lesion. Continuous data were expressed as mean and standard deviation. Survival analysis was carried out according to Kaplan-Meier. RESULTS: Overall, 64 patients aged 80 ± 11 years were included, with 49 (76.6%) presenting with critical limb ischemia. Lesions were classified as TASC D in 54.7% of the cases. The length of the lesions was 295 ± 64 mm and 3 ± 1 stents were implanted. The 30-day mortality was null but two patients (3.1%) presented nonvascular major complications. With a follow-up of 27 ± 17 months, 22 patients (34.3%) died including three of vascular causes. The healing of the trophic disorder was obtained in 77.5% of the cases. The rate of amputation was 10.9%. The 6-, 12-, and 24-month primary patency rates were 79.7%, 66.6%, and 60.9%, respectively. The 6-, 12-, and 24-month rates of freedom from target lesion revascularization were 96.3%, 73.9%, and 71.9%, respectively. The 6-, 12-, and 24-month survival rates were 90.3%, 83.6%, and 65.6%, respectively. CONCLUSIONS: The 12-month primary patency rate of ETLFBS is acceptable. This strategy constitutes an acceptable alternative in patients presenting with critical limb ischemia and a limited life expectancy.