Six Years' Experience With a Novel Dissection-Specific Stent-Graft to Prevent Distal Stent-Graft-Induced New Entry.

INTRODUCTION: Thoracic endovascular aortic repair (TEVAR) in chronic dissection is associated with a risk for distal stent-graft-induced new entry (dSINE) in up to a quarter of cases. We assess the mid-term outcome of a novel dissection-specific stent-graft (DSSG), which is a custom-made device based on the Cook Alpha platform, with a modified graft design and a distal endovascular elephant trunk without any supporting stent to reduce the radial force on the dissection membrane at the distal landing zone. METHODS: A retrospective single-center study of chronic dissection patients at high risk of dSINE who received an elective endovascular repair with DSSG from January 2017 to June 2023. The primary outcome is Kaplan-Meier (KM) estimated freedom from dSINE during follow-up. Secondary outcomes included technical success, aortic remodeling, and anatomical evaluation of the distal landing zone in cases with dSINE during follow-up versus those without. RESULTS: Thirty patients (24 males) with a median age of 66 years [range=31-78] underwent elective TEVAR with the DSSG. The majority, n=27 (90%), had previous aortic repair; 7 (23%) had established connective tissue disease, and 6 (20%) had established dSINE after previous stent-graft implantation as an indication for TEVAR. Technical success was achieved in n=29 (97%). Median follow-up was 38.5 months (4.3-76.4), and KM estimated freedom from dSINE at 1 and 3 years was 95.6% (SE 0.043) and 89% (SE 0.081), respectively Four cases developed dSINE during follow-up. The median distance from the distal stent-graft to the coeliac trunk was 74mm (range=18-123) in the dSINE group versus 26mm (range=0-74) in the non-dSINE group (p=0.049). Median proximal tangential aortic angulation in the distal landing zone was 38.5° (range=26°-50°) in the dSINE group compared to 21° (range=3-61°) in the non-dSINE group (p=0.052). CONCLUSIONS: The Use of a novel DSSG with low radial force for TEVAR in the setting of chronic dissection is safe and feasible, with remodeling outcomes comparable with standard TEVAR. The reduced distal radial force in the DSSG does not eliminate the risk for dSINE over time, with new entries occurring, particularly in cases where the distal landing zone is in a tortuous aortic segment and not close to the coeliac trunk. CLINICAL IMPACT: Using the novel dissection-specific stent-graft with reduced radial force is safe and feasible but does not completely eliminate the risk of dSINE occurring over time. The exact positioning of the distal stent-graft in a straight aortic segment, close to the coeliac trunk, may be of importance to further mitigate the risk.

Mortality with Paclitaxel-Coated Devices in Peripheral Artery Disease.

BACKGROUND: The results of a recent meta-analysis aroused concern about an increased risk of death associated with the use of paclitaxel-coated angioplasty balloons and stents in lower-limb endovascular interventions for symptomatic peripheral artery disease. METHODS: We conducted an unplanned interim analysis of data from a multicenter, randomized, open-label, registry-based clinical trial. At the time of the analysis, 2289 patients had been randomly assigned to treatment with drug-coated devices (the drug-coated-device group, 1149 patients) or treatment with uncoated devices (the uncoated-device group, 1140 patients). Randomization was stratified according to disease severity on the basis of whether patients had chronic limb-threatening ischemia (1480 patients) or intermittent claudication (809 patients). The single end point for this interim analysis was all-cause mortality. RESULTS: No patients were lost to follow-up. Paclitaxel was used as the coating agent for all the drug-coated devices. During a mean follow-up of 2.49 years, 574 patients died, including 293 patients (25.5%) in the drug-coated-device group and 281 patients (24.6%) in the uncoated-device group (hazard ratio, 1.06; 95% confidence interval, 0.92 to 1.22). At 1 year, all-cause mortality was 10.2% (117 patients) in the drug-coated-device group and 9.9% (113 patients) in the uncoated-device group. During the entire follow-up period, there was no significant difference in the incidence of death between the treatment groups among patients with chronic limb-threatening ischemia (33.4% [249 patients] in the drug-coated-device group and 33.1% [243 patients] in the uncoated-device group) or among those with intermittent claudication (10.9% [44 patients] and 9.4% [38 patients], respectively). CONCLUSIONS: In this randomized trial in which patients with peripheral artery disease received treatment with paclitaxel-coated or uncoated endovascular devices, the results of an unplanned interim analysis of all-cause mortality did not show a difference between the groups in the incidence of death during 1 to 4 years of follow-up. (Funded by the Swedish Research Council and others; ClinicalTrials.gov number, NCT02051088.).

An updated systematic review and meta-analysis of pre-emptive aortic side branch embolization to prevent type II endoleaks after endovascular aneurysm repair.

OBJECTIVE: Pre-emptive embolization of aortic side branches may be effective in preventing type II endoleaks (T2EL) based on a previous systematic review and meta-analysis by our group. Data up to 2019 was, however, only based on retrospective studies. The aim of the current study was to update the meta-analysis and evaluate the current evidence on this treatment strategy. METHODS: A systematic literature search was performed with the same keywords and strategies used in the previous study. The complementary search included all articles published from January 1, 2019, through May 29, 2022. The incidence of aneurysm sac growth was the primary outcome of interest. RESULTS: Four new studies were identified, including one randomized controlled study and one nationwide registry-based retrospective study. Overall, the incidence of sac size enlargement was 4.3% in the embolization group compared with 6.8% in the control group (odds ratio [OR], 0.38; 95% confidence interval [CI], 0.26-0.55), the incidence of T2EL was 19.7% vs 37.4% (OR, 0.38; 95% CI, 0.30-0.47), and the incidence of reintervention for T2EL was 1.2% vs 11.2% (OR, 0.12; 95% CI, 0.06-0.23). CONCLUSIONS: Current evidence confirms lower incidence of aneurysm sac growth, T2EL, and reinterventions when pre-emptive embolization of aortic side branches is performed in conjunction with endovascular aneurysm repair, compared with no embolization. However, a higher level of evidence is still required to support a broad change of practice, including data on cost-effectiveness and on the potential effect on rupture.

Longitudinal Assessment of Inflammatory Activity in Acute Type B Aortic Dissection with Integrated Fluorodeoxyglucose Positron Emission Tomography/Magnetic Resonance Imaging.

OBJECTIVE: The significance of the inflammatory response in the natural course of acute type B aortic dissection (ATBAD) is unknown. The aim was to characterise inflammation and its transformation over time in ATBAD using 18F-fluorodeoxyglucose (FDG) positron emission tomography (PET) with contrast enhanced magnetic resonance imaging (MRI). METHODS: Ten patients underwent FDG-PET/MRI within two weeks of ATBAD (acute phase), three to four months (subacute phase), nine to 12 months (early chronic phase), and 21 to 24 months (late chronic phase) after ATBAD. Target background ratios (TBRs) were measured in the ascending aorta, aortic arch, and descending aorta. MRI inflammatory markers were assessed in the descending aorta. RESULTS: Ten patients were included: median age 69 years, median clinical follow up 32 months. In the acute phase there was increased FDG uptake in the descending aorta (maximum TBR 5.8, SD [standard deviation] 1.3) compared with the ascending aorta (TBR 3.3, SD 0.8, p < .010) and arch (TBR 4.2, SD 0.6, p = .010). The maximum TBR of the descending aorta decreased from the acute to subacute phase (TBR 3.5, SD 0.6, p = .010) and further to the early chronic phase (TBR 2.9, SD 0.4, p = .030) but was stable thereafter. The acute phase maximum TBR in the ascending aorta (TBR 3.3) and arch (TBR 4.2) decreased to the subacute phase (ascending: TBR 2.8, SD 0.6, p = .020; arch: TBR 2.7, SD 0.4, p = .010) and was stable thereafter. Four patients underwent surgical aortic repair (three for aortic dilatation at one, five, and 28 months and one for visceral ischaemia at three weeks). MRI signs of inflammation were present in all surgically treated patients vs. two of six of medically treated patients (p= .048). CONCLUSION: ATBAD is associated with increased FDG uptake in the acute phase primarily in the descending aorta, but also involving the aortic arch and ascending aorta, indicating an inflammatory response in the whole aorta. Inflammation subsides early in the ascending aorta and arch (three months), whereas it stabilised later in the descending aorta (nine to 12 months). MRI signs of inflammation were more frequent in patients who later needed surgical treatment and merit further investigation.

A systematic review of experimental and clinical studies reporting on in situ laser fenestration of aortic endografts.

OBJECTIVE: We have summarized the available in situ laser fenestration (ISLF) literature, including experimental studies with their subsequent recommendations regarding the optimal fenestration technique and fabric, and the short- and mid-term results of clinical studies. METHODS: A systematic search for English-language reports was performed in MEDLINE, the Cochrane Database, and EMBASE in accordance with the PRISMA (preferred reporting items for systematic reviews and meta-analysis) guidelines by two investigators (C.F.P. and D.L.). The search period was from inception of the databases to August 31, 2020. The search terms included in situ, laser, fenestration, and endograft. A quality assessment of the studies was performed using the Newcastle-Ottawa scale by two other investigators (G.T. and A.W.) independently. RESULTS: A total of 19 clinical studies were included, with a total of 428 patients (390 cases of supra-aortic trunk ISLF, 38 cases of visceral vessel ISLF). The technical success rate was 96.9% and 95.6% for supra-aortic and visceral vessel ISLF, respectively. Most studies had reported <12 months of follow-up. The longest available follow-up was in one study at 5 years for left subclavian artery ISLF and 17 months for visceral vessel ISLF. Overall, the quality of the evaluated clinical studies was low. Six experimental studies were included, with the highest level of evidence suggesting fenestration of multifilament polyethylene terephthalate grafts, followed by dilation with either a 6- or 8-mm noncompliant balloon. CONCLUSIONS: The results from experimental studies favor the use of multifilament polyethylene terephthalate, followed by dilation with noncompliant balloons as the most durable in vitro technique for ISLF. The short-term outcomes for arch and visceral vessel revascularization have been promising, with low rates of in-hospital mortality, stroke, and end-organ ischemia. Nonetheless, the long-term durability of ISLF has not yet been determined, and ISLF should be limited to selected symptomatic and urgent cases.

A SiMplified bARe-Wire Target Vessel (SMART) Technique for Fenestrated Endovascular Aortic Repair.

PURPOSE: The aim of this study was to present a new technique for fenestrated endovascular aortic aneurysm repair (FEVAR) and to review its preliminary results. The SiMplified bARe-wire Target vessel (SMART) technique for FEVAR aims to simplify the procedure by avoiding guiding sheaths into visceral arteries during the main graft deployment. MATERIALS AND METHODS: The SMART technique requires a 12 to 16Fr contralateral introducer, depending on number of fenestrations-compared with standard 18 to 22Fr for 3 to 4 FEVAR-to achieve target vessel catheterization and stenting during FEVAR by avoiding the use of parallel 6 to 7Fr guiding sheaths into each visceral vessel. Fenestrations are sequentially catheterized, assisted by a steerable sheath. A Rosen wire is maintained in each fenestration, with a single sheath parked in the final target vessel while releasing the fenestrated graft. Data on patients treated for pararenal or thoracoabdominal aortic aneurysms with FEVAR, adopting the SMART technique, were retrospectively reviewed. End points were technical success, intraprocedural variables, 90-day mortality, major adverse events (MAEs), and target vessel patency. RESULTS: From May 2018 to December 2020, 57 consecutive patients were treated for pararenal or thoracoabdominal aortic aneurysms. Median total procedure time and total fluoroscopy time were 223 (196-271) minutes and 81 (71-94) minutes, respectively. Primary technical success was 96.4% (55/57). No misalignment occurred from graft deployment. The total number of fenestrations was 169, including 54 left and 53 right renal arteries, 43 superior mesenteric arteries and 18 celiac trunks (3.0±0.9 vessels/patient), with target vessel technical success of 98.2%. During the first 90 days, there were no deaths (0%). The MAEs included acute kidney injury (AKI) in 3 patients (5%) with no new dialysis onset, respiratory failure requiring prolonged ventilation in 2 patients (4%), myocardial ischemia in 1 patient (2%), but no lower limb ischemia, stroke, or spinal cord ischemia (SCI) occurred. After a mean follow-up of 14±10 months, there was 1 aortic-related death. Primary and assisted primary target vessel patency was 94.6%±1.8 and 97.0%±1.3% respectively. CONCLUSIONS: The SMART technique proved to be a safe alternative to standard FEVARs, with excellent technical result and acceptable target vessel patency at mid-term, while reducing the risk for introducer-induced lower limb ischemia, related complications, and morbidity. CLINICAL IMPACT: This study evalautes the outcome of fenestrated endovascular aortic repair (FEVAR) procedures at Uppsala university hospital using a simplified bare-wire Target vessel (SMART) technique. The SMART technique requires a smaller contralateral introducer compared to standard 18-22Fr for 3-4 FEVAR to achieve target vessel catetherization and stenting. Fifty-seven consecutive patients were treated for pararenal or thoracoabdominal aortic aneurysms. The SMART technique proved to be a safe alternative to standard FEVARs with excellent technical result and acceptable target vessel patency at mid-term, while reducing the risk for introducer-induced lower limb ischemia, related complications, and morbidity.

Early Experience With a Novel Dissection-Specific Stent-Graft to Prevent Distal Stent-Graft-Induced New Entry Tears After Thoracic Endovascular Repair of Chronic Type B Aortic Dissections.

BACKGROUND: The aim was to report short and mid-term outcomes of a novel, investigational, dissection-specific stent-graft (DSSG), specifically designed to address the features of chronic type B aortic dissection (CTBAD) and reduce the risk of distal stent-graft-induced new entry tears (dSINE). MATERIALS AND METHODS: A retrospective single center cohort study of all patients undergoing TEVAR with the DSSG for CTBAD from January 1, 2017 to January 31, 2020. The DSSG, which is a modified stent-graft based on the Cook Zenith Alpha Thoracic platform, has no proximal barbs, and a customized longer body length with substantial taper. The second and third distal Z-stents are sited internally to avoid any contact of the metal skeleton with the dissection membrane and have reduced radial force, while the most distal stent was removed creating a distal 30 mm unsupported Dacron graft. RESULTS: Sixteen patients (13 males, 3 females) with a median age of 66 years (range 31-79 years) underwent elective TEVAR of CTBAD using the DSSG. Six patients (38%) had an underlying connective tissue disorder. The median tapering was 10 mm (range 4 mm-21 mm) and median length 270 mm (range 210-380 mm). Technical success was achieved in all but one case (96%). One patient died within 30 days, due to retrograde type A dissection with cardiac tamponade. The 30-day rate of stroke, spinal cord ischemia, and re-interventions was 0%. After median imaging follow-up time of 17 months (range 1-31 months), one patient developed a dSINE 4 months after the index procedure. After median survival follow-up of 23 months (range 2-35 months), one late death occurred due to traumatic brain injury, while no aortic-related death occurred during follow-up. Complete false lumen (FL) thrombosis was achieved in 9 patients while the remaining 6 showed partial FL thrombosis. No instances of diameter increase at the level oftreated aortic segment were noted with serial measurements showing either stable (n = 7) or decreased (n = 8) maximal transverse diameter. CONCLUSIONS: Use of a novel DSSG with low radial force for TEVAR in the setting of CTBAD is safe and feasible. This early real-world experience shows promising mid-term effectiveness with low rates of dSINE or unplanned re-interventions and satisfactory aortic remodeling during follow-up. Longer follow-up is needed, however, before any firm conclusions can be drawn.

Endovascular treatment of chronic aortic dissection with fenestrated and branched stent grafts.

OBJECTIVE: Chronic aortic dissection with aneurysm development that includes the aortic arch and/or thoracoabdominal aorta (TAAA) is traditionally treated with open or hybrid surgery. Total endovascular treatment with fenestrated and branched aortic repair (F/B-EVAR) has recently been introduced as a less invasive alternative. The aim was to report the short- and midterm outcomes from a single tertiary vascular center. METHODS: All patients with chronic aortic dissection treated with F/B-EVAR from 2010 to 2019 at Uppsala University Hospital were identified. Perioperative and postoperative parameters were analyzed, with focus on short- (<30 days) and midterm survival, complication, and reintervention rates. RESULTS: F/B-EVAR was performed on 26 patients (median age, 63 years; range, 33-87 years; 18 men; median aortic diameter, 70 mm; range, 50-98 mm); with a median follow-up of 23 months (range, 0.5-118.0 months). One patient underwent both arch and TAAA repair. Overall, 13 arch repairs (arch group) after type A (n = 8) and type B (n = 5) dissection (all elective) were performed, and 14 TAAA repairs (TAAA group) after type A (n = 5) and type B (n = 9) dissection (one rupture). A total of 72 aortic branches were targeted (22 arch, 50 TAAA). Short-term technical success was achieved in 24 of 27 procedures (89%). Failures were related to one intraoperative retrograde type A dissection (RTAD) requiring open conversion (arch group), one persistent type IC endoleak on completion angiography (arch group), and one persistent type III endoleak (TAAA group). Mortality was 4% (n = 1) at 30 days and related to a second RTAD that occurred after discharge and was found on autopsy. Both RTADs occurred in patients with chronic type B dissection undergoing fenestrated arch repair. Paraplegia occurred in three cases (two arch, one TAAA) (11%), none permanent, and stroke in three cases (one arch, one TAAA) (11%); one was permanent. In the midterm, endoleaks were detected in 12 patients (44%); persistent false lumen flow (n = 3), type IB (n = 1), type IC (n = 3), type II (n = 7), and type IIIC (n = 2). The 3-year survival (Kaplan-Meier) of the arch repair was 75% and for the TAAA, 93%. Freedom from reintervention at 3 years were 100% for arch repairs and 48% for TAAA. In patients with a follow-up of more than 6 months (n = 23), all had stable or decreased aortic diameters and complete false lumen thrombosis at the level of stent graft was present in 65% (n = 15). CONCLUSIONS: Endovascular treatment of postdissection aneurysms is feasible, with acceptable short-term and midterm outcomes. RTAD after fenestrated and branched endovascular arch repair warrants caution when performed on patients with native ascending aortas, and reinterventions are frequent in TAAA repair.

Editor's Choice - Pre-Operative Moderate to Severe Chronic Kidney Disease is Associated with Worse Short-Term and Mid-Term Outcomes in Patients Undergoing Fenestrated-Branched Endovascular Aortic Repair.

OBJECTIVE: To review experience of fenestrated-branched endovascular aortic repair (F-BEVAR) for pararenal/thoraco-abdominal aortic aneurysms (PRAA/TAAA) and to assess the association between pre-operative moderate to severe chronic kidney disease (CKD) and post-operative outcomes. METHODS: All consecutive patients undergoing (elective and non-elective) F-BEVAR at a single centre (1 January 2011 - 1 July 2019) were identified. Renal function was calculated as the estimated glomerular filtration rate (eGFR) using the Modification of Diet in Renal Disease formula. Accordingly, presence of moderate to severe CKD was defined as eGFR < 60 mL/min/1.73m2. RESULTS: Overall, 202 consecutive patients (mean age 72 ± 8 years; 25% women) underwent F-BEVAR for the treatment of PRAA/TAAA during the study period. Of these, 51 had a history of moderate to severe CKD (none on chronic haemodialysis). No statistically significant differences were found in demographics and major comorbidities between patients with or without a history of CKD. The overall peri-operative mortality rate was 2%, without statistically significant differences between study groups (p = .26). Patients with prior CKD had statistically significantly higher rates of acute kidney injury (AKI) (37% vs. 12%, p < .001). At three years, overall survival was statistically significantly lower in patients with history of CKD compared with those without pre-operative CKD (57% vs. 82%, p = .010). Similarly, freedom from renal function decline at three years was statistically significantly poorer in patients with prior history of CKD compared with those without pre-operative CKD (43% vs. 80%, p = .020). In a multivariable analysis CKD was independently associated with higher odds of peri-operative AKI (OR 2.8, 95% CI 1.9 - 5.8, p = .030), renal function decline (OR 4.9, 95% CI 1.7 - 9.2, p = .003), and all cause mortality (HR 3.2, 95% CI 1.2 - 8.6, p = .020). CONCLUSION: Despite low peri-operative mortality rates that are comparable to patients with unimpaired renal function, occurrence of AKI was statistically significantly higher in subjects with pre-existing moderate to severe CKD. History of CKD was independently associated to renal function decline and poorer midterm survival.

Short-term and Mid-term Outcomes after Use of the Native Infrarenal Aorta as Distal Landing Zone for Fenestrated-Branched Endovascular Aortic Repair.

BACKGROUND: This study aimed to examine outcomes after use of the native infrarenal aorta as distal landing zone for fenestrated-branched endovascular aortic repair (F-BEVAR) of pararenal-thoracoabdominal aortic aneurysms (PRAA-TAAA). METHODS: All F-BEVAR procedures for treatment of PRAA-TAAA (2011-2019) at 2 aortic centers were examined. The outcomes of interest were as follows: i) technical success, ii) perioperative morbidity, iii) preservation of lumbar arteries and the inferior mesenteric artery, iv) type IB endoleaks, v) reinterventions, vi) survival, vii) aneurysm sac behavior, and viii) infrarenal aortic changes. RESULTS: Twenty consecutive patients with distal landing in the native infrarenal aorta were included (median age 71 years; 25% men). The median number of visible lumbar arteries at baseline was 7, and a patent inferior mesenteric artery (IMA) before the operation was present in 19 (95%) of the cases. There were no deaths within 30 days. One patient (5%), operated on with a 4-BEVAR for a type 2 TAAA, experienced spinal cord ischemia (permanent paraplegia). The median decrease in the number of visible lumbar arteries at the first postoperative scan was 3 from the baseline value, whereas a patent IMA was preserved in 12 out of 19 patients. Only in one case (5%), a type IB endoleak was noted for an overall technical success rate of 95%, which required a standard EVAR 20 months after the initial operation. The median follow-up duration for the study cohort was 491 days; all patients were alive at the longest available individual follow-up, and no instances of new-onset type IB endoleaks were observed. Another 3 late reinterventions (in addition to the one mentioned previously) were performed during midterm follow-up, all because of target vessel instability. In patients with ≥12 months of follow-up after the index procedure (n = 12, 60% of the entire cohort), no instances of aneurysm sac increase >5 mm were noted; the median largest aortic diameter was 51 mm with a median difference from baseline of -6 mm. The median distal landing zone diameter increase was 4 mm from baseline but never beyond the nominal stent-graft diameter, whereas the median aortic bifurcation diameter differed 1 mm from baseline. CONCLUSIONS: This preliminary experience shows that the use of the native infrarenal aorta as a distal landing zone for F-BEVAR is safe in the short term and midterm in patients with suitable anatomy, allowing the sparing of collateral vessels. Longer follow-up is warranted to assess durability.