Penumbra indigo percutaneous aspiration thrombectomy system in the treatment of aortic endograft iliac limb occlusion: results from an Italian Multicentre Registry

Objective: This study aimed to evaluate the safety and effectiveness of the Penumbra Indigo percutaneous aspiration thrombectomy (PAT) system in the clinical presentation of iliac limb occlusion (ILO) after endovascular aortic repair (EVAR).Methods: A retrospective, observational, multicentre study conducted in eight Italian vascular centres. Consecutive patients presenting with ILO after EVAR were eligible. To assess vessel revascularisation, Thrombo-aspiration In Peripheral Ischaemia (TIPI) classification (score 0-3) was used at presentation (t1), after PAT (t2), and after adjunctive procedures (t3). Successful revascularisation was considered TIPI 2-3 (near complete or complete). Primary intra-operative outcomes were technical success (TS) of Indigo PAT and combined TS of PAT associated with adjunctive procedures when needed. Primary follow up outcomes were safety and effectiveness at one, six, and 12 months.Results: From September 2019 to December 2021, there were 48 ILO and 17 patients (35%) [median age 75 years, IQR 71, 83 years; male, 14 (82%); urgent, 8 (47%)] were treated and enrolled. The median time after primary EVAR was 24 months (IQR 0, 42 months). The median clot age from ILO diagnosis to PAT was three days (IQR 1, 12 days). Ten patients (59%) presented with limb threatening ischaemia. At t1, TIPI 0 and 1 was present in 13 (76%) and four (24%) cases, respectively. At t2, primary TS (TIPI 2-3) was achieved in 14 cases (82%) after Indigo PAT (p < .001). Fifteen patients (88%) required adjunctive procedures (14 re-linings, one surgical patch angioplasty). At t3, combined TS was achieved in 16 cases (94%). Intra-operative complication included one (6%) distal embolisation, treated successfully. The 30 day mortality was one case (6%) due to pneumonia. At one, six, and 12 months, clinical success was 100% without ILO recurrence. The median follow up was 23 months (IQR 11, 41 months): at 18 months, survival and freedom from re-intervention were 91 + 8% and 90 + 9%, respectively.Conclusion: This study reports for the first time the efficacy and safety of Penumbra Indigo PAT for ILO after EVAR, with promising technical and clinical success up to one year

Use of an Off the Shelf Inner Branch Thoraco-abdominal Endograft for the Treatment of Juxtarenal and Pararenal Aortic Aneurysms

Objective: To investigate outcomes of an off the shelf pre-loaded inner branched endograft (E-nside) for the treatment of juxtarenal and pararenal abdominal aortic aneurysms (JP-AAAs). Methods: Data from a multicentre registry (INBREED), including patients treated with the E-nside endograft, were collected and analysed prospectively. Patients treated for JP-AAA were included. Pre-operative clinical and anatomical characteristics, procedural data, and 30 day and one year outcomes were recorded. Endpoints were technical success, 30 day death, major adverse events (MAEs), and one year freedom from target vessel instability. Results: Of 185 consecutively treated patients, 47 (25.4%) had a JP-AAA (juxtarenal n = 10, 21%; pararenal n = 37, 79%) and were included in the study; 183 target vessels were incorporated through an inner branch. Procedural setting was emergency or urgent in 18 patients (38%) owing to a contained aortic rupture (n = 2, 4%), symptomatic aneurysm (n = 4, 9%), or aneurysm > 70 mm (n = 12, 26%). The mean length of aortic coverage above the coeliac trunk was 116 ± 7 mm. Technical success was 100% and 30 day mortality rate 4% (n = 2 urgent cases). The 30 day cumulative MAE rate was 26% (n = 12): two stroke (4%); and seven spinal cord ischaemia (15%), with six in an elective setting (21%) and one in an urgent setting (6%), and five leading to permanent paraplegia or paraparesis (10%). Freedom from target vessel instability was 99% after 30 days and 97 ± 3% after one year. Conclusion: Use of an off the shelf inner branched device for treating JP-AAA was feasible in urgent and elective settings, with high technical success and satisfactory target vessel stability at one year. In the treatment of JP-AAA, stroke and spinal cord ischaemia may be associated with arm access and the increased aortic coverage that the design brings

Early Outcomes of a Novel Off the Shelf Preloaded Inner Branch Endograft for the Treatment of Complex Aortic Pathologies in the ItaliaN Branched Registry of E-nside EnDograft (INBREED)

Objective: The aim of this study was to investigate the early outcomes of a novel off the shelf pre-loaded inner branched thoraco-abdominal endograft (E-nside) in the treatment of aortic pathologies.Methods: Data from a physician initiated national multicentre registry on patients treated with the E-nside endograft, were prospectively collected and analysed. Pre-operative clinical and anatomical characteristics, procedural data, and early outcomes (90 days) were recorded in a dedicated electronic data capture system. The primary endpoint was technical success. Secondary endpoints were early mortality (90 days), procedural metrics, target vessel patency, endoleak rate, and major adverse events (MAEs) at 90 days.Results: In total, 116 patients from 31 Italian centres were included. Mean + standard deviation (SD) patient age was 73 + 8 years and 76 (65.5%) were male. Aortic pathologies included degenerative aneurysm in 98 (84.5%), post-dissection aneurysm in five (4.3%), pseudoaneurysm in six (5.2%), penetrating aortic ulcer or intramural haematoma in four (3.4%), and subacute dissection in three (2.6%). Mean + SD aneurysm diameter was 66 + 17 mm; aneurysm extent was Crawford I -III in 55 (50.4%), IV in 21 (19.2%), pararenal in 29 (26.7%), and juxtarenal in four (3.7%). The procedure setting was urgent in 25 (21.5%) patients. Median procedural time was 240 minutes (interquartile range [IQR] 195, 303), with a median contrast volume of 175 mL (IQR 120, 235). The endograft's technical success rate was 98.2% and the 90 day mortality rate was 5.2% (n = 6; 2.1% for elective repair and 16% for urgent repair). The 90-days cumulative MAE rate was 24.1% (n = 28). At 90 days, there were 10 (2.3%) target vessel related events (nine occlusions and one type IC endoleak) and one type 1A endoleak requiring re-intervention.Conclusion: In this real life, non-sponsored registry, the E-nside endograft was used for the treatment of a broad spectrum of aortic pathologies, including urgent cases and different anatomies. The results showed excellent technical implantation safety and efficacy, as well as early outcomes. Longer term follow up is needed to better define the clinical role of this novel endograft

Outcomes of off-the-shelf preloaded inner branch device for urgent endovascular thoraco-abdominal aortic repair in the ItaliaN Branched Registry of E-nside EnDograft

Objective: The aim of this study was to report the outcomes of endovascular urgent thoracoabdominal aortic (TAAA) repair, using an off-the-shelf preloaded inner branch device (E-nside; Artivion). Methods: Data from a physician-initiated national multicenter registry, including patients treated with E-nside endograft (INBREED) were prospectively collected (2020-2024); only urgent cases were included in this study. Primary outcomes were technical success and mortality at 30 days. Secondary outcomes were spinal cord ischemia rate, stroke rate, major adverse events (MAE) as also branch instability at 12 months. Results: Of 185 patients enrolled in the INBREED, 64 (34.5%) were treated in a urgent setting and were included in the study. Reason for urgent repair was presence of aneurysm-related symptoms in 31 patients (48.4%), a contained rupture in eight (12.5%), and a large aneurysm >80 mm in 25 (39.1%). Extent of repair was I to III in 32 patients (50%) and IV in 32 (50%); 18 (28%) had a narrow (<25 mm) paravisceral aortic lumen. An adjunctive proximal thoracic endograft was deployed in 29 patients (45.3%); a distal bifurcated abdominal endograft was used in 33 (51.5%). Two hundred forty-nine target vessels (97.2%) were successfully incorporated through an inner branch from an upper arm (81.2%) or femoral (18.8%) access. A balloon expandable stent was used in 184 (75.7%) target vessels, a self-expandable stent in 59 (24.3%). Mean time for target vessel bridging was 39.9 ± 28.4 minutes per target vessel. Thirty-day cumulative major adverse event (MAE) rate was 28%, and mortality occurred in five patients (9.1%). There was one postoperative stroke (1.6%), and the spinal cord ischemia (SCI) rate was 8% (n = 5). For the 249 target vessels successfully incorporated through an inner branch, 1-year freedom from target vessel instability was 93% ± 3% after 1 year. Conclusions: The E-nside represents a valid solution for the urgent treatment of TAAAs, including symptomatic and ruptured TAAAs, as well as large asymptomatic TAAAs that cannot wait for a custom-made device. The preloaded inner branches and available proximal and distal graft diameters might be useful in urgent settings and provided satisfactory early and 1-year results, in terms of both endograft and target vessel stability. Further studies are required to assess the clinical role of E-nside for urgent TAAA repair

Insight from an Italian Delphi Consensus on EVAR feasibility outside the instruction for use: the SAFE EVAR Study

BACKGROUND: The SAfety and FEasibility of standard EVAR outside the instruction for use (SAFE-EVAR) Study was designed to define the attitude of Italian vascular surgeons towards the use of standard endovascular repair (EVAR) for infrarenal abdominal aortic aneurysm (AAA) outside the instruction for use (IFU) through a Delphi consensus endorsed by the Italian Society of Vascular and Endovascular Surgery (Societa Italiana di Chirurgia Vascolare ed Endovascolare - SICVE). METHODS: A questionnaire consisting of 26 statements was developed, validated by an 18 -member Advisory Board, and then sent to 600 Italian vascular surgeons. The Delphi process was structured in three subsequent rounds which took place between April and June 2023. In the first two rounds, respondents could indicate one of the following five degrees of agreement: 1) strongly agree; 2) partially agree; 3) neither agree nor disagree; 4) partially disagree; 5) strongly disagree; while in the third round only three different choices were proposed: 1) agree; 2) neither agree nor disagree; 3) disagree. We considered the consensus reached when >70% of respondents agreed on one of the options. After the conclusion of each round, a report describing the percentage distribution of the answers was sent to all the participants. RESULTS: Two -hundred -forty-four (40.6%) Italian Vascular Surgeons agreed to participate the first round of the Delphi Consensus; the second and the third rounds of the Delphi collected 230 responders (94.3% of the first -round responders). Four statements (15.4%) reached a consensus in the first rounds. Among the 22 remaining statements, one more consensus (3.8%) was achieved in the second round. Finally, seven more statements (26.9%) reached a consensus in the simplified last round. Globally, a consensus was reached for almost half of the proposed statements (46.1%). CONCLUSIONS: The relatively low consensus rate obtained in this Delphi seems to confirm the discrepancy between Guideline recommendations and daily clinical practice. The data collected could represent the source for a possible guidelines' revision and the proposal of specific Good Practice Points in all those aspects with only little evidence available

Great saphenous vein versus expanded polytetrafluoroethylene graft in patients undergoing elective treatment of popliteal artery aneurysm with posterior approach

Background: Aim of this study is to compare 30-day and 5-year outcomes of great saphenous vein (GSV) vs. expanded polytetrafluoroethylene (ePTFE) graft in patients undergoing elective treatment of popliteal artery aneurysm (PAA) using a posterior approach. Methods: Between January 2010 and December 2023, a retrospectively maintained dataset of all consecutive asymptomatic PAAs who underwent open repair with posterior approach or endovascular repair in 40 centers was investigated. Out of of 971 cases, 525 patients were included in the present analysis. These were further divided into: posterior approach with GSV graft (252, GSV Group), and posterior approach with ePTFE graft (273, ePTFE Group). Thirty-day outcomes were assessed and compared. During follow-up, survival, primary patency, secondary patency, freedom from reintervention(s), and amputation-free survival were compared between the two groups using log-rank tests. Uni- and multivariate Cox regression analyses were performed in ePTFE Group to find predictive factors of poor outcomes. Results: Two groups were homogeneous in terms of preoperative risk factors and morphological data. Median follow-up duration was similar [24 months (IQR 10 - 36) GSV Group vs. 21 months (IQR 7-47) ePTFE Group; p = .123]. At 5 years, there were no differences between the two groups in terms of survival (84.7% GSV Group vs. 86.1% ePTFE Group; p = .097, log-rank = 2.756), secondary patency (94.9% GSV Group vs. 89.4% ePTFE Group; p = .068, log-rank = 3.336), and amputation-free survival (99.1% GSV Group vs. 99.6% ePTFE Group; p = .567, log-rank = .328). Five-year primary patency (89.5% GSV Group vs. 76.2% ePTFE Group; p = .007, log-rank = 7.239), and freedom from reintervention(s) (92.8% GSV Group vs. 80.6% ePTFE Group; p = .011, log-rank = 6.449) were significantly higher in GSV Group. Using multivariate analysis in ePTFE Group, factors compromising primary patency were patients on dialysis (p = .054, OR = 3.641), and patients that were not on any preoperative antiplatelet therapy or anticoagulation (p = .019, OR = 5.532), whilst none of the perioperative factors affected freedom from reintervention(s). Conclusion: GSV as graft guaranteed better primary patency with less reinterventions rates at mid-term follow-up after treatment of PAAs via a posterior approach. Patients on dialysis and who were not on any preoperative antiplatelet therapy or anticoagulation had lower patency rates

Documenting the Recovery of Vascular Services in European Centres Following the Initial COVID-19 Pandemic Peak: Results from a Multicentre Collaborative Study

Objective: To document the recovery of vascular services in Europe following the first COVID-19 pandemic peak. Methods: An online structured vascular service survey with repeated data entry between 23 March and 9 August 2020 was carried out. Unit level data were collected using repeated questionnaires addressing modifications to vascular services during the first peak (March – May 2020, “period 1”), and then again between May and June (“period 2”) and June and July 2020 (“period 3”). The duration of each period was similar. From 2 June, as reductions in cases began to be reported, centres were first asked if they were in a region still affected by rising cases, or if they had passed the peak of the first wave. These centres were asked additional questions about adaptations made to their standard pathways to permit elective surgery to resume. Results: The impact of the pandemic continued to be felt well after countries’ first peak was thought to have passed in 2020. Aneurysm screening had not returned to normal in 21.7% of centres. Carotid surgery was still offered on a case by case basis in 33.8% of centres, and only 52.9% of centres had returned to their normal aneurysm threshold for surgery. Half of centres (49.4%) believed their management of lower limb ischaemia continued to be negatively affected by the pandemic. Reduced operating theatre capacity continued in 45.5% of centres. Twenty per cent of responding centres documented a backlog of at least 20 aortic repairs. At least one negative swab and 14 days of isolation were the most common strategies used for permitting safe elective surgery to recommence. Conclusion: Centres reported a broad return of services approaching pre-pandemic “normal” by July 2020. Many introduced protocols to manage peri-operative COVID-19 risk. Backlogs in cases were reported for all major vascular surgeries

Second asymptomatic carotid surgery trial (ACST-2): a randomised comparison of carotid artery stenting versus carotid endarterectomy

Background: Among asymptomatic patients with severe carotid artery stenosis but no recent stroke or transient cerebral ischaemia, either carotid artery stenting (CAS) or carotid endarterectomy (CEA) can restore patency and reduce long-term stroke risks. However, from recent national registry data, each option causes about 1% procedural risk of disabling stroke or death. Comparison of their long-term protective effects requires large-scale randomised evidence. Methods: ACST-2 is an international multicentre randomised trial of CAS versus CEA among asymptomatic patients with severe stenosis thought to require intervention, interpreted with all other relevant trials. Patients were eligible if they had severe unilateral or bilateral carotid artery stenosis and both doctor and patient agreed that a carotid procedure should be undertaken, but they were substantially uncertain which one to choose. Patients were randomly allocated to CAS or CEA and followed up at 1 month and then annually, for a mean 5 years. Procedural events were those within 30 days of the intervention. Intention-to-treat analyses are provided. Analyses including procedural hazards use tabular methods. Analyses and meta-analyses of non-procedural strokes use Kaplan-Meier and log-rank methods. The trial is registered with the ISRCTN registry, ISRCTN21144362. Findings: Between Jan 15, 2008, and Dec 31, 2020, 3625 patients in 130 centres were randomly allocated, 1811 to CAS and 1814 to CEA, with good compliance, good medical therapy and a mean 5 years of follow-up. Overall, 1% had disabling stroke or death procedurally (15 allocated to CAS and 18 to CEA) and 2% had non-disabling procedural stroke (48 allocated to CAS and 29 to CEA). Kaplan-Meier estimates of 5-year non-procedural stroke were 2·5% in each group for fatal or disabling stroke, and 5·3% with CAS versus 4·5% with CEA for any stroke (rate ratio [RR] 1·16, 95% CI 0·86–1·57; p=0·33). Combining RRs for any non-procedural stroke in all CAS versus CEA trials, the RR was similar in symptomatic and asymptomatic patients (overall RR 1·11, 95% CI 0·91–1·32; p=0·21). Interpretation: Serious complications are similarly uncommon after competent CAS and CEA, and the long-term effects of these two carotid artery procedures on fatal or disabling stroke are comparable. Funding: UK Medical Research Council and Health Technology Assessment Programme