Endovascular navigation with Fiber Optic RealShape technology.

OBJECTIVE: Fiber Optic RealShape (FORS) technology has recently been introduced as an adjunctive guidance technology that allows real-time three-dimensional visualization of dedicated endovascular devices while avoiding radiation exposure. It consists of equipment which sends pulses of light through hair-thin optical fibers that run within a dedicated hydrophilic wire and selective catheters. The purpose of the study was to report the observed benefits and limitations related to the first edition of FORS technology. METHODS: Data were collected prospectively from the first 50 patients undergoing FORS-guided endovascular repair at a single center between February 2020 and February 2021 as part of the global multicenter FORS Learn registry. All consecutive, elective procedures with one or more navigation tasks attempted with FORS were included. Factors related to FORS navigation task success were assessed. The time required for the catheterization of each task as well as the amount of radiation exposure (fluoroscopy time, dose area product, and estimated skin dose) were collected. A per-task analysis was conducted. End points included the success rate in achieving a stable FORS-guided catheterization, catheterization time, and radiation dose during catheterization. RESULTS: During the study period from February 2020 to February 2021, 50 patients were treated using FORS technology. Forty-five patients were treated for aortic aneurysm, 4 for iliac artery aneurysm, and 1 for splenic artery aneurysm. Overall, 201 navigation tasks were completed for these procedures and FORS was used in 186 tasks (92.5%). No FORS-related complication was recorded and a success rate of 60.2% (n = 116) was observed. Target vessel (TV) angle of 45° or greater, TV stenosis, and the renal arteries as navigation tasks (compared with celiac artery or superior mesenteric artery) were associated with a lower success rate. Catheterization of a TV through a branch more frequently required a standard catheter in combination with the FORS-enabled guidewire. Successful task catheterization using FORS guidance was associated with a shorter catheterization time 6 minutes (interquartile range, 3-11 minutes) versus 16 minutes (interquartile range, 10-24 minutes) (P < .001) and lower radiation exposure compared with unsuccessful catheterization (dose area product, 4.4 cGy/cm2 vs 12.5 cGy/cm2; P < .001). CONCLUSIONS: FORS technology was implemented successfully as a new guidance technology in a complex endovascular aortic repair program and was associated with an encouraging success rate and a high potential for radiation reduction.

The Knickerbocker Technique: Technical Aspects and Single-Center Results of a New Endovascular Method for False Lumen Occlusion in Chronic Aortic Dissection.

PURPOSE: To describe the technical aspects and early results of a new endovascular fenestration method for false lumen occlusion in chronic aortic dissection: the Knickerbocker Technique. METHODS: A retrospective observational study including all consecutively treated patients between November 1, 2012, through May 31, 2016, who underwent thoracic endovascular aortic repair with false lumen occlusion using the Knickerbocker Technique for thoracic false lumen aneurysm in chronic aortic dissection in a tertiary care center. Primary endpoints consisted of technical (correct deployment of the stent-graft) and clinical (false lumen occlusion) success. Secondary endpoints included overall survival and morbidity after 30 days. In 12 patients, follow-up computed tomography angiogram (CTA) was available and aortic remodeling was evaluated. RESULTS: We identified 16 eligible patients (75% men, mean age: 69 years, range: 52-80 years). Technical success was 94%. Overall survival after 30 days was 100%; there was 1 aortic reintervention (additional false lumen embolization due to endoleak type 1a in 1 patient). Median total follow-up was 31.5 months (range: 3-66 months). Four (25%) of 16 patients died during follow-up, in 3 of those patients the cause of death is unknown, and 1 patient developed cardiac tamponade after being treated by fenestrated thoracic endovascular aortic repair. Imaging follow-up with CTA was available in 12 patients (median imaging follow-up: 27.5 months, range: 1-57 months). Nine (75%) of 12 patients showed thoracic aortic remodeling, and in 3 patients aneurysm size was stable. No patient showed aneurysm growth. CONCLUSION: The Knickerbocker Technique is a feasible endovascular fenestration method to achieve false lumen occlusion and aortic remodeling in chronic aortic dissection with low invasiveness.

Fiber Optic RealShape (FORS) Technology for Endovascular Navigation in Severe Tortuous Vessels.

PURPOSE: The purpose of this study was to describe the use of a wire and catheters embedded with optical fiber (Fiber Optic RealShape [FORS]) to catheterize tortuous target vessels avoiding radiation. TECHNIQUE: A virtual biplane vies was simulated coupling traditional x-ray system, preoperative CT scan, and FORS system to treat an isolated hypogastric aneurysm. Despite the complex anatomy, catheterization of all target vessels was possible in 12 minutes with 19 seconds of fluoroscopy time (Radiation Exposure 3.8 mGy×cm2). A minimal invasive endovascular exclusion of the aneurysm was achieved through selective coil-embolization of the iliolumbar artery and implantation of balloon expandable covered stents, thus preserving the perfusion of the superior gluteal artery. CONCLUSION: FORS guidance allowed catheterization of a target vessel with challenging anatomy with a low radiation exposure.

The preservation of accessory renal arteries should be considered the treatment of choice in complex endovascular aortic repair.

OBJECTIVE: The objective of this study was to evaluate renal function and renal parenchymal length changes secondary to the coverage or preservation of accessory renal arteries (ARAs) in complex aortic repair. METHODS: This was a single-center retrospective study identifying all patients undergoing fenestrated or branched endovascular aortic repair (f-b EVAR) who presented with ARAs. Two groups were created, a preserved ARA group, with incorporation of the vessel as a dedicated fenestration or branch in the endograft plan, and a non-preserved ARA group, without incorporation of them. Early >30% decline of glomerular filtration rate (GFR), kidney infarcts, and endoleaks were evaluated. Mid-term results with freedom from kidney shrinkage (defined as length decrease >10%) at follow-up, freedom from GFR decrease >30%, or need for postoperative dialysis at follow-up were also analyzed. Primary assisted patency of incorporated ARAs was calculated. RESULTS: From 2011 through 2020, 145 patients undergoing complex aortic repair presented with an ARA. After excluding ruptured aneurysms, 33 patients had the ARA preserved with their incorporation into the stent graft (preserved ARA group), and 99 did not have preservation of them (not-preserved ARA group). There were no statistical differences in demographics or type of aneurysm. Patients in the ARA-preserved group had more ARAs (median of two per patient vs one in the non-preserved ARA group; P = .01) and bigger ARAs (median 4 vs 3 mm in the non-preserved ARA group; P = .001). Early postoperative worsening >30% of GFR (23% vs 6%; P = .03) as well as postoperative renal infarction (57% vs 6%; P = .001) and ARA-related endoleaks (20% vs 0%; P = .01) were statistically higher for the not-preserved ARA group. Mid-term kidney length showed significant shrinkage in the not-preserved ARA group compared with the ARA preserved group (9.7% vs 0%; P = .001). Freedom from >30% GFR decline at 2 years was significantly higher for the preserved ARA group (83% vs 47%; P = .01).Two-year primary assisted patency of incorporated ARA was 94%. CONCLUSIONS: Complex aortic repair incorporation of ARA is feasible, with low complications and good primary assisted patency at 2 years. It leads to less postoperative early renal dysfunction as well as higher freedom for mid-term renal disfunction and kidney shrinkage.

Systematic review on transcaval embolization for type II endoleak after endovascular aortic aneurysm repair.

BACKGROUND: A persistent endoleak type II (ET II) after endovascular repair for aortic aneurysms is not always a benign condition and has been associated to sac expansion, rupture, and reintervention. A variety of different endovascular approaches are available for ET II treatment. The aim of this systematic review was to assess the currently available literature on transcaval embolization for ET II treatment after standard or complex endovascular aortic aneurysm repair. METHODS: This systematic review protocol was registered to the PROSPERO (CRD42021289686). The PRISMA guidelines and patient, intervention, comparison, outcome (P.I.C.O.) model was followed. A data search of the literature was conducted, using PubMed, EMBASE via Ovid, and CENTRAL databases, until September 30, 2021. Only studies reporting on ET II embolization using the transcaval approach after endovascular aneurysm repair were included. Studies reporting on different type of endoleak treatment or any other embolization approach were excluded. The quality of studies was assessed using the Newcastle-Ottawa Scale. Primary outcomes were technical success and freedom from ET II persistence during follow-up; secondary outcomes were any postoperative complication associated with the transcaval embolization and need for reintervention. RESULTS: The search yielded 2861 articles in total. Eight articles were included, reporting on 117 patients and 128 transcaval embolizations. The indication for treatment was ET II presence with sac expansion of more than 5 mm; in two studies, the presence of persistent endoleak has set the indication to intervene. The technical success was 91.4% (117/128); a variety of embolic materials were used, including coils, thrombin, and glue. Three cases of deep vein thrombosis were recorded and the remaining morbidity and mortality were null. Follow-up was ranging between 0 and 25 months. Out of 8 studies, persistent ET II rate was 12.8% and 18 reinterventions were performed (14.1%,), including 10 transcaval coil embolizations (56%). Sac expansion was reported in 11 cases, out of 3 studies (17%). Only one case of death, not associated with transcaval embolization, was recorded. CONCLUSIONS: Transcaval embolization for ET II treatment presents a high technical success and low mortality in the early and mid-term period. ET II persistence rate is low during the available 12-month follow-up.

Physician-Modified Endograft With Inner Branches for the Treatment of Complex Aortic Urgencies.

PURPOSE: To describe the use of physician-modified endograft (PMEG) with the exclusive use of inner branches or in combination with fenestrations for the urgent treatment of complex aortic aneurysms. TECHNIQUE: We present two urgent cases. A patient with a 6.8 cm saccular juxtarenal aneurysm and another patient with a contained rupture of the thoracoabdominal aorta right above the celiac trunk (CT). In both cases, a Cook Zenith TX2 thoracic endograft was back-table modified, in the first case by adding three fenestrations and one inner branch for the left renal artery to improve sealing due to its partial involvement in the aneurysm and, in the second case, with the use of two inner branches for the CT and superior mesenteric artery. Both procedures were successful, with uneventful postoperative courses and complete aneurysm exclusion on postoperative CT angiography. CONCLUSION: Use of PMEGs with inner branches is feasible for urgent repair in complex aortic anatomy.

Modular Endo-Bentall Procedure Using a "Rendez-Vous Access".

PURPOSE: The concept of a single endovascular valve-carrying conduit device was designated endo-Bentall, but published experience is limited to a single case. This technical note describes an alternative modular endo-Bentall technique and a novel access technique to implant it. TECHNIQUE: A 82-year-old woman with chest pain referred for a 10 cm symptomatic aneurysm of the distal arch and descending aorta. An ascending aortic aneurysm of 5.5 cm prevented endovascular aortic arch repair due to lack of a proximal landing zone. The technique is a modular approach combining a physician-modified endograft (PMEG) with 3 large fenestrations for coronary artery perfusion and a transcatheter aortic valve implantation (TAVI). A "rendez-vous access" with a transapical and transfemoral through-and-through wire offered rapid sequential deployment in a modular fashion of both components. The PMEG was deployed first, landing 5 mm deep in the left ventricular outflow tract (LVOT) and the transcatheter aortic valve was implanted few millimeters below. The endo-Bentall procedure was combined with endovascular aortic arch repair. CONCLUSION: A modular endo-Bentall procedure combining a PMEG and TAVI is feasible and adaptable to emergent setting using the "rendez-vous access."

Non-Standard Management of Target Vessels With the Inner Branch Arch Endograft: A Single-Center Retrospective Study.

PURPOSE: The purpose of this study was to evaluate early and mid-term results of non-standard management of the supraaortic target vessels with the use of the inner branch arch endograft in a single high-volume center. MATERIAL AND METHODS: A single-center retrospective study including all patients undergoing implantation of an inner branch arch endograft from December 2012 to March 2021, who presented a non-standard management of the supraaortic target vessels (any bypass other than a left carotid-subclavian or landing in a dissected target vessel). Technical success, mortality, reinterventions, endoleak (EL), and aortic remodeling at follow-up were analyzed. RESULTS: Twenty-four patients were included. In 17 (71%) cases, the non-standard management was related to innominate artery (IA) compromise (12 with IA dissection, 2 with short IA, 2 with short proximal aortic landing zone that required occlusion of IA, 1 with occluded IA after open arch repair). Two (8%) cases were related to an aberrant right subclavian artery (RSA), 1 patient (4%) due to the concomitant presence of a left vertebral artery (LVA) arising from the arch and an occluded left subclavian artery (LSA), and another patient presented with an occluded LSA distal to a dominant vertebral artery. Three (13%) cases were exclusively related to management in patients with genetic aortic syndromes. Twenty (83%) patients had a previous type A aortic dissection. Ten (42%) patients presented a thoracic or thoracoabdominal aortic aneurysm and 8 (33%) patients an arch aneurysm, 6 of them associated to false lumen (FL) perfusion. There were 2 (8%) perioperative minor strokes, and 1 patient with perioperative mortality. Seven patients presented an early type I endoleak, all resolved at follow-up. Seven patients required reinterventions during follow-up (7 reinterventions related to continuous false lumen perfusion, 3 related to Type Ia endoleak, 2 related to surgical bypass). All patients who presented with FL perfusion had complete FL thrombosis at follow-up. No patient presented aneurysm growth at follow-up. CONCLUSIONS: The use of the inner branch arch endograft with a non-standard management of the supraaortic target vessels is a possible option. Despite a high reintervention rate, regression or stability of the aneurysmal diameter was achieved in all the patients with follow-up.

One-Year Results of ZBIS Iliac Branch Device With an Off-Label Connection Limb.

PURPOSE: The purpose of this article is to study 1-year results of Zenith branch iliac endovascular graft (ZBIS) with the off-label use of a 13 mm spiral Z limb to connect to the aortic main body. MATERIALS AND METHODS: A retrospective review from 2015 to 2019 of all iliac branch devices (IBDs) was performed at 1 institution that were connected to an aortic main body with a 13 mm spiral Z limb and had at least 1-year follow-up with computed tomography (CT). Primary endpoints are freedom from ZBIS separation from the connection limb, endoleak (EL), or reintervention at 1 year. Secondary endpoints are primary and secondary ZBIS patency, presence of any EL, and aortic reinterventions. RESULTS: Of 149 IBDs implanted in this period, 45 ZBIS in 35 patients were connected with a 13 mm limb and had a 1-year CT; 97% of patients had common iliac artery (CIA) aneurysms, 7% of patients had hypogastric artery (HA) aneurysms, and 30% of patients had bilateral ZBIS implantation. Technical success was 98%. In 84% of cases, the Advanta V12 was used as the HA mating stent; 56% of patients had an EL, mostly type II, which resolved spontaneously in 70% at 1 year, and 9% of ZBIS required reinterventions at 1 year (2 for thrombosis, 2 for type Ic EL from HA mating stent). One-year ZBIS primary patency and secondary patency were 96% and 100%, respectively. No EL was noted to be related to the 13 mm connection limb. No migration or separation of the devices occurred. CONCLUSIONS: The use of 13 mm spiral Z limb to connect a ZBIS with the main body in our series yields a high technical success rate and good 12-month outcomes without device separation or migration.

Early and Mid-Term Durability of Surgeon-Modified and Custom-Made Fenestrated Devices for the Treatment of Complex Aortic Pathology.

BACKGROUND: Fenestrated endovascular aneurysm repair (F-EVAR) has allowed successful treatment of patients with complex aortic aneurysms. Custom-made devices (CMDs) are manufactured by companies and tailored to the patient's anatomy to incorporate target vessels, while there is also the "off label" alternative with the devices modified by a surgeon in the operating room: surgeon-modified FEVAR (sm-FEVAR). This study aims to present and compare technical durability of CMDs- and sm-FEVAR for complex abdominal and thoracoabdominal aortic pathologies. METHODS: A retrospective cohort study was undertaken including all consecutive patients treated with sm- or CMD-FEVAR during a 3-year period in a single center. Only cases with at least 3 reno-visceral target vessels were included. Primary outcomes were technical success, and freedom from endoleak (EL) (Ia or III; all branch related) and re-intervention during follow-up period. Mortality and morbidity were also recorded. RESULTS: Thirty-two sm-FEVAR patients (81,3% male) and 79 CMD-FEVAR patients (77,2% male) were included. Indication for sm-FEVAR was exclusively urgent, while all CMD- FEVAR were elective. Technical success was similar in sm-FEVAR (100%) and CMD-FEVAR (98,7%) (P = 0.523). Mean follow-up was 16.3 ± 13 and 20 ± 17.3 months for sm-FEVAR and CMD- FEVAR, respectively (P = 0.28). The freedom from EL Ia rate was 91.7% [standard error (SE) 5.7%] at 12 months in sm-FEVAR, while it was 97.7% (SE 2.2%) and 92.3% (SE 4.3%) at 12 and 24 months, respectively in CMD-FEVAR (P = 0.69). The freedom from EL III rate was 95.5% (SE 4.4%) and 88% (SE 8.2%) at 12 and 24 months, respectively in sm-FEVAR, while it was 92.1% (SE 3.8%) and 89.2% (SE 4.7%) at 12 and 24 months, respectively in CMD-FEVAR (P = 0.68). The freedom from re-intervention rate was 91.6% (SE 5.7%) and 84.6% (SE 8.6%) at 12 and 24 months, respectively in sm-FEVAR, while it was 91.7% (SE 4%) and 83.4% (SE 5.9%) at 12 and 24 months, respectively in CMD-FEVAR (P = 0.90). The survival rate was 87.5% (5.8%) and 76.3% (7.9%) at 1 and 12 months, respectively in sm-FEVAR, while it was 93.7% (2.7%) at 1 month in CMD-FEVAR without any other death during FU period. No bridging stent occlusions were noted during follow-up period in any patient. CONCLUSION: Sm-FEVAR offers good technical success and mid-term clinical outcomes in urgent cases of complex aortic pathologies. Its durability is acceptable and comparable to CMD-FEVAR with a relatively low re-intervention rate.

Transcaval embolization for type II endoleak after endovascular aortic repair of infrarenal, juxtarenal, and type IV thoracoabdominal aortic aneurysm.

OBJECTIVE: This study aims to determine the outcomes of transcaval embolization (TCE) for type II endoleak after infrarenal endovascular aortic repair (EVAR) and fenestrated/branched EVAR (F/BEVAR). METHODS: A retrospective single-center cohort study of all consecutive TCE procedures between August 2015 and August 2019 was performed to investigate technical success, in-hospital morbidity, and 30-day mortality as well as clinical success during follow-up. The indication for TCE was an aneurysm sac growth of 5 mm or more owing to a type II endoleak after EVAR for infrarenal or F/BEVAR for juxtarenal and type IV thoracoabdominal aortic aneurysm. RESULTS: A total 25 TCE procedures in 24 patients (95.8% male) were included. Technical success was 96.0% (24/25); selective and nonselective TCE were performed in 48% of patients. The in-hospital morbidity and 30-day mortality were 0%. The median follow-up was 23.1 months (interquartile range, 10.9-40.1 months). Freedom from type II endoleak-related reintervention was 84.6% at 12 months. Comparing clinical success after TCE, reintervention was necessary in 16.7% of patients after nonselective and 20% of patients after selective TCE. Regarding TCE after EVAR vs F/BEVAR, reintervention was performed in 12.5% of EVAR and 33.3% of F/BEVAR patients during follow-up. CONCLUSIONS: TCE is an acceptable treatment alternative for type II endoleak with aneurysm sac enlargement and can be used after EVAR for infrarenal abdominal aortic aneurysms and F/BEVAR for juxtarenal abdominal aortic aneurysms and type IV thoracoabdominal aortic aneurysms.

A health insurance claims analysis on the effect of female sex on long-term outcomes after peripheral endovascular interventions for symptomatic peripheral arterial occlusive disease.

OBJECTIVE: Several reports have addressed sex disparities in peripheral arterial occlusive disease (PAOD) treatment with inconclusive or even conflicting results. However, most previous studies have neither been sufficiently stratified nor used matching or weighting methods to address severe confounding. In the present study, we aimed to determine the disparities between sexes after percutaneous endovascular revascularization (ER) for symptomatic PAOD. METHODS: Health insurance claims data from the second-largest insurance fund in Germany, BARMER, were used. A large cohort of patients who had undergone index percutaneous ER of symptomatic PAOD from January 1, 2010 to December 31, 2018 were included in the present study. The study cohort was stratified by the presence of intermittent claudication, ischemic rest pain, and wound healing disorders. Propensity score matching was used to adjust for confounding through differences in age, treated vessel region, comorbidities, and pharmacologic treatment. Sex-related differences regarding cardiovascular event-free survival, amputation-free survival, and overall survival within 5 years of surgery were determined using Kaplan-Meier time-to-event curves, log-rank test, and Cox regression analysis. RESULTS: In the present study, 50,051 patients (47.2% women) were identified and used to compose a matched cohort of 35,232 patients. Among all strata, female patients exhibited lower mortality (hazard ratio [HR], 0.69-0.90), fewer amputations or death (HR, 0.70-0.89), and fewer cardiovascular events or death (HR, 0.78-0.91). The association between female sex and improved long-term outcomes was most pronounced for the patients with intermittent claudication. CONCLUSIONS: In the present propensity score-matched analysis of health insurance claims, we observed superior cardiovascular event-free survival, amputation-free survival, and overall survival during 5 years of follow-up after percutaneous ER in women with symptomatic PAOD. Future studies should address sex disparities in the open surgical treatment of PAOD to illuminate whether the conflicting data from previous reports might have resulted from insufficient stratification of the studies.

Revascularization of occluded renal artery stent grafts after complex endovascular aortic repair and its impact on renal function.

BACKGROUND: Acute occlusion of renal bridging stent grafts after fenestrated/branched endovascular aortic repair (F/B-EVAR) is an acknowledged complication with high morbidity that often results in chronic dialysis dependence. The feasibility and effect of timely or late (≥6 hours of ischemia) renal artery revascularization has not been adequately reported. METHODS: We performed a retrospective, multicenter study across 11 tertiary institutions of all consecutive patients who had undergone revascularization of renal artery stent graft occlusions after complex EVAR. The end points were technical success, association between ischemia time and renal function salvage, interventional complications, mortality, and mid-term outcomes. RESULTS: From 2009 to 2019, 38 patients with 46 target vessels (TVs; eight bilateral occlusions) were treated for renal artery occlusions after complex EVAR (mean age, 63.5 ± 10 years; 63.2% male). Six patients had a solitary kidney (15.8%). Of the 38 patients, 16 (42.1%) had undergone FEVAR and 22 (57.9%) had undergone BEVAR. The technical success rate was 95.7% (44 of 46 TVs). The recanalization technique used was sole aspiration thrombectomy in 5.3%, aspiration thrombectomy and stent graft relining in 52.6%, and sole stent graft relining in 36.8%. The median renal ischemia time was 27.5 hours (range, 4-720 hours; interquartile range, 4-36 hours). Most patients (94.4%) had been treated after ≥6 hours of renal ischemia time, and 55.6% had been treated after 24 hours. In 14 patients (36.8%), renal function had improved after intervention (mean glomerular filtration rate improvement, 14.2 ± 9 mL/min/1.73 m2). However, 24 patients (63.2%) showed no improvement. Improvement of renal function did not correlate with the length of renal ischemia time. Of the 14 patients with bilateral renal artery occlusion or a solitary kidney, 9 experienced partial recovery of renal function and no longer required hemodialysis. In-hospital mortality was 2.6%. The cause of renal stent graft occlusion could not be identified in 50% of the TVs (23 of 46). However, in 19 (41.3%), significant stenosis or a kink of the renal stent graft was found. The median follow-up was 11 months (interquartile range, 0-28 months). The estimated 1-year patient survival and patency rate of the renal stent grafts was 97.4% and 83.8%, respectively. CONCLUSIONS: Revascularization of occluded renal bridging stent grafts after F/B-EVAR is a safe and feasible technique and can lead to significant improvement of renal function, even after long ischemia times (>24 hours) of the renal parenchyma or bilateral occlusion, as long as residual perfusion of the renal parenchyma has been preserved. Also, the long-term patency rates justify aggressive management of renal artery occlusion after F/B-EVAR.

Aortic Remodeling After Custom-Made Candy-Plug for Distal False Lumen Occlusion in Aortic Dissection.

PURPOSE: To report a single-center experience with the use of a custom-made Candy-Plug (CP) for distal false-lumen (FL) occlusion in subacute and chronic aortic dissection (AD). MATERIALS AND METHODS: A retrospective single-center analysis was conducted on consecutive patients with subacute and chronic AD who were treated with a custom-made CP for distal FL occlusion using 3 design generations (CP I to CP III) from October 2013 to September 2019. RESULTS: A custom-made CP was used in 57 patients. Of these, 34 patients (29 males, mean age 62±10 years) were treated with a CP I vs 23 patients (16 males, mean age 59±17 years) with CP II/III. Technical success was achieved in 57 (100%) patients. Clinical success was achieved in 54 (95%) patients; 33 (97%) in CP I group vs 21 (91%) patients in CP II/III group, p=0.116. The mean hospital stay was 10±8 days (9±5 days in CP I group vs 13±9 days in CP II/III, p=0.102). The 30-day computed tomography angiography (CTA) confirmed successful CP placement at the intended level in all patients within both groups. Early complete FL occlusion was achieved in 50 (88%) patients; 30 (88%) patients in CP I group vs 20 (87%) in CP II/III group, p=0.894. Follow up CTA was available in 44 (77%) patients. Of these; 30/34 (88%) patients in CP I group with mean follow-up 29±17 months) vs. 14/23 (61%) patients with mean follow-up 14±5 months in CP II/III group. Thoracic aortic remodeling was achieved in 34/44 (77%) patients; 25/30 (83%) patients in CP I group vs 9/14 (64%) patients in CP II/III group, p=0.197. The aneurysm size remained stable in 9/44 (20%) patients; 5/30 (17%) patients in CP I group vs 4/14 (29%) patients in CP II/III group, p=0.741. The thoracic aneurysm increased size was seen in 1/44 (2%) patient. This patient was in CPII/III group. CONCLUSION: CP technique using custom-made devices is technically feasible with a low mortality and morbidity, and a high rate of aortic remodeling. Both, the original design (CP I) and newer designs with a self-closing central sleeve (CP II and CP III) showed similar excellent outcomes.

Management of Descending Thoracic Aortic Diseases: Similarities and Differences Among Cardiovascular Guidelines.

Cardiovascular societies have developed recommendations regarding the management of thoracic aortic diseases. While improvements in treatment have been observed during the past decade in regard to patient selection, thoracic endovascular aortic repair (TEVAR) and associated techniques, and high-volume centralization, the broad expansion of TEVAR has raised considerations about its indications, appropriateness, limitations, and application. The aim of this systematic review was to assess the similarities and differences among current cardiovascular societies' guidelines for the management of thoracic aortic diseases. The MEDLINE, EMBASE, and Cochrane Central Register of Controlled Trials were searched from January 2009 to May 2020. The initial search identified 990 articles. After exclusion of duplicate or inappropriate articles, the final analysis included 5 articles from cardiovascular societies published between 2010 and 2020. Selected controversial topics were analyzed, including diagnosis, imaging, spinal cord ischemia prevention, and management of the most important thoracic aortic pathologies. The analysis included data concerning the therapeutic approach in acute and chronic type B aortic dissection, penetrating aortic ulcer, intramural hematoma, thoracic aortic aneurysm, and traumatic aortic injury, as well a discussion of inflammatory aneurysms, aortitis, and genetic syndromes. The review presents consistent and controversial recommendations, as well as "gray zone" issues that need further investigation. There was significant overlap and agreement among the 5 societies regarding the management of thoracic aortic diseases. Especially in dissection and aneurysm management, TEVAR has established its role as the treatment of choice. However, robust evidence is still needed in many aspects of the management of thoracic aortic pathologies.

How Does Female Sex Affect Complex Endovascular Aortic Repair? A Single Centre Cohort Study.

OBJECTIVE: There is growing evidence of a female patient disadvantage in complex endovascular aortic repair using fenestrated and branched endografts (FB-EVAR) primarily related to peri-procedural events including ischaemic and access vessel complications. This study aimed to determine the impact of sex differences on treatment patterns, and in hospital outcomes in a single centre cohort. METHODS: This was a retrospective cross sectional single centre cohort study of all consecutive FB-EVAR procedures provided to patients with asymptomatic pararenal and thoraco-abdominal aortic aneurysm (TAAA) between 1 January 2010 and 28 February 2021. Adjusted multivariable logistic regression models were developed using backward (Wald) elimination of variables to determine the independent impact of female sex on short term outcomes. RESULTS: In total, 445 patients (24.3% females, median age 73.0 years, IQR 66, 78) were included. Female patients had a smaller aneurysm diameter, less frequent coronary artery disease (29.6% vs. 44.8%, p = .007) and history of myocardial infarction (2.8% vs. 15.4%, p < .001) when compared with males. Females were more frequently treated for TAAA than males (49.1% vs. 25.2%, p < .001). The median length of post-procedural hospital stay was 10 days in females and 9 in males. In adjusted analyses, female sex was independently associated with higher mortality (odds ratio [OR] 10.135, 95% CI 2.264 - 45.369), post-procedural complications (OR 2.500, 95% CI 1.329 - 4.702), spinal cord ischaemia (OR 4.488, 95% CI 1.610 - 12.509), sepsis (OR 4.940, 95% CI 1.379 - 17.702), and acute respiratory insufficiency (OR 3.283, 95% CI 1.015 - 10.622) after pararenal aortic aneurysm repair during the hospital stay. CONCLUSION: In this analysis of consecutively treated patients, female sex was associated with increased in hospital mortality, peri-procedural complications, and spinal cord ischaemia after elective complex endovascular repair of pararenal aortic aneurysm, while no differences were revealed in the TAAA subgroup. These results suggest that sex related patient selection and peri-procedural management should be studied in future research.

Sex Disparities in Long Term Outcomes After Open Surgery for Chronic Limb Threatening Ischaemia: A Propensity Score Matched Analysis of Health Insurance Claims.

OBJECTIVE: Several studies suggest a disadvantage for women in peri-operative morbidity and mortality after open surgery in peripheral arterial occlusive disease. In addition to their heterogeneity regarding design and analysed cohorts, long term data are mostly missing. This study aimed to determine sex disparities in outcomes after open revascularisation in chronic limb threatening ischaemia (CLTI). METHODS: Using health insurance claims data of the second largest insurance fund in Germany, BARMER, a large cohort of patients was sampled consecutively for analysis including index open surgical revascularisations of CLTI performed between 1 January 2010, and 31 December 2018. Propensity score matching was used to adjust for confounding. Sex related differences regarding overall survival, amputation free survival (AFS), and cardiovascular event free survival (CVEFS) during the five years after surgery were determined using Kaplan-Meier time to event curves, log rank test, logistic, and Cox regression. RESULTS: Among 9 526 patients (49.5% women) in the entire cohort, 6 502 patients were matched. Before matching, women were older at presentation (78.0 vs. 71.8 years, p < .001) and suffered more often from multiple comorbidities (van Walraven score > 9, 55.5% vs. 50.6%, p < .001). During the hospital stay, there were 692 (7.3%) deaths, while 4 631 deaths (48.6%) occurred during the follow up. In the matched cohort, the median follow up was 746 days for women and 871 days for men. In the matched analyses, female sex was significantly associated with better overall survival (hazard ratio, HR, 0.80, log rank p < .001), AFS (HR 0.81, log rank p < .0001), and CVEFS (HR 0.84, log rank p < .001) five years after the index treatment. CONCLUSION: In this largest propensity score matched analysis of health insurance claims to date from Germany, evidence was found for better long term outcomes in women after open surgical revascularisations for chronic limb threatening ischaemia. Future guidelines and studies should address the impact of sex on patient selection practice and outcomes to determine the underlying reasons for existing disparities.

The interrelationship between diabetes mellitus and peripheral arterial disease.

This systematic review examined the interrelationship between concomitant diabetes mellitus (DM) and peripheral arterial disease (PAD). The objective was to determine differences in the prevalence as well as in the outcomes in diabetic vs. non-diabetic PAD patients. The current review followed a study protocol that was published online in German in 2017. The search included societal practice guidelines, consensus statements, systematic reviews, meta-analyses, and observational studies published from 2007 to 2020 reporting symptomatic PAD and concomitant DM in patients undergoing invasive open-surgical and endovascular revascularizations. German and English literature has been considered. Eligibility criteria were verified by three independent reviewers. Disagreement was resolved by discussion involving a fourth reviewer. 580 articles were identified. After exclusion of non-eligible studies, 61 papers from 30 countries remained, respectively 850,072 patients. The included studies showed that PAD prevalence differed between diabetic vs. non-diabetic populations (20-50% vs. 10-26%), and further by age, gender, ethnicity, duration of existing diabetes, and geographic region. The included studies revealed worse outcomes regarding perioperative complications, amputation rate, and mortality rate in diabetic patients when compared to non-diabetic patients. In both groups, the amputation rates decreased during the research period. This review emphasizes an interrelationship between PAD and DM. To improve the outcomes, early detection of PAD in diabetic patients, and vice versa, should be recommended. The results of this systematic review may help to update societal practice guidelines.

Combined fenestrated-branched endovascular repair of the aortic arch and the thoracoabdominal aorta.

OBJECTIVE: The aim of our study was to evaluate patients who underwent extensive endovascular aortic stent graft coverage (from the aortic arch to abdominal aorta) in terms of early and midterm clinical outcomes. METHODS: A retrospective multicenter study was undertaken. All patients were treated with extensive endovascular aortic stent graft coverage with fenestrated and branched endografts at three experienced endovascular centers. RESULTS: Between 2012 and 2017, there were 33 patients (22 male [67%]) treated with a combination of fenestrated-branched stent grafts in the aortic arch and the thoracoabdominal aorta. Most of the patients (20/33 [61%]) had fenestrated-branched endovascular aneurysm repair (fb-EVAR) of the thoracoabdominal aorta as a second-stage procedure after thoracic arch (fb-Arch) repair, 10 had fb-Arch repair as the first procedure, and three patients had a single-stage procedure. The mean age was 67 ± 13 years, and the mean interval between procedures was 13 ± 12 months. For fb-Arch repair, 20 fenestrated and 13 branched devices were used; for fb-EVAR, 23 fenestrated, 5 branched, and 5 composite devices were used. The use of spinal drainage was more common in fb-EVAR (20/33 [61%]). Technical success was 100%. Mean hospital stay was 15 ± 13 days for fb-Arch repair and 12 ± 9 days for fb-EVAR. Two patients died in the hospital after fb-EVAR, resulting in a 30-day mortality of 6% (2/33). No deaths occurred during the fb-Arch repair component or in the single-stage cases. Four patients developed spinal cord injury (12%), 1 had permanent paraplegia (3%), and 2 patients had a neurologic event (1 stroke [3%] and 1 transient ischemic attack [3%]). Six patients (18%) died during a mean follow-up of 23 ± 17 months. The survival at 12 months after the second procedure was 72%, and the freedom from any reintervention was 82%. The 12-month freedom from reintervention was 87% for fb-Arch repair and 81% for fb-EVAR. CONCLUSIONS: Extensive endovascular coverage of the aorta for aortic disease seems to be a feasible procedure in experienced centers, with acceptable perioperative morbidity and mortality. Spinal cord ischemia appears acceptable despite extensive aortic coverage.

Incidence, predictors, and outcomes of spinal cord ischemia in elective complex endovascular aortic repair: An analysis of health insurance claims.

OBJECTIVE: This study aimed to determine predictors and outcomes associated with spinal cord ischemia (SCI) after elective fenestrated or branched endovascular aneurysm repair (F/BEVAR) of thoracoabdominal aortic aneurysm (TAAA), abdominal aortic aneurysm (AAA), or aortic dissection. METHODS: Health insurance claims data of Germany's third largest insurance provider, DAK-Gesundheit, were used to investigate SCI in elective F/BEVAR performed between 2008 and 2017. The International Classification of Diseases and German Operation and Procedure Classification System were used. We stratified the results into F/BEVAR with one or two (AAA) vs three or more (TAAA) fenestrations or branches. RESULTS: A total of 877 patients (18.9% female; 5.8% with SCI) matching the inclusion criteria were identified during the study period. SCI occurred more often after F/BEVAR of TAAA vs AAA (10.7% vs 3.0%; P < .001). SCI was associated with female sex in the AAA group (odds ratio, 3.87; 95% confidence interval [CI], 1.25-11.15; P = .014) and with cardiac arrhythmias in the TAAA group (odds ratio, 2.98; 95% CI, 1.24-7.06; P = .013). Compared with patients without SCI, SCI patients were more likely to suffer from drug use disorders (eg, opioids, cannabinoids, sedatives) in the TAAA group (17.6% vs 2.1%; P < .05). After F/BEVAR of TAAA, the occurrence of SCI was associated with higher 90-day mortality (14.7% vs 1.1%; P < .05), longer postoperative hospital stay (22 vs 9 days; P < .05), and severe adverse events, such as acute respiratory insufficiency (44.1% vs 12.7%), acute renal failure (35.3% vs 11.3%), and pneumonia (29.4% vs 4.9%; all P < .05). In adjusted analyses, SCI was associated with worse long-term survival after F/BEVAR for TAAA (hazard ratio, 2.54; 95% CI, 1.37-4.73; P < .003). CONCLUSIONS: Female AAA patients and TAAA patients with cardiac arrhythmias are at highest risk for development of SCI after F/BEVAR. The occurrence of this event was strongly associated with higher major complication rates and worse short-term and long-term survival. This emphasizes a need to further illuminate the value of spinal cord protection protocols in F/BEVAR.