An International, Expert-based, Delphi Consensus Document on Controversial Issues in the Management of Abdominal Aortic Aneurysms.

OBJECTIVE: As a result of conflicting, inadequate or controversial data in the literature, several issues concerning the management of patients with abdominal aortic aneurysms (AAAs) remain unanswered. The aim of this international, expert-based Delphi Consensus document was to provide some guidance for clinicians on these controversial topics. METHODS: A 3-Round Delphi Consensus document was produced with 44 experts on 6 pre-specified topics regarding the management of AAAs. All answers were provided anonymously. The response rate for each round was 100%. RESULTS: Most participants (42 of 44; 95.4%) agreed that a minimum case volume/year is essential (or probably essential) for a center to offer open/endovascular AAA repair (EVAR). Furthermore, 33 of 44 (75.0%) believed that AAA screening programs are (probably) still clinically effective and cost-effective. Additionally, most panelists (36 of 44; 81.9%) voted that surveillance after EVAR should be (or should probably be) lifelong. Finally, 35 of 44 (79.7%) participants thought that women smokers should (or should probably/possibly) be considered for screening at 65 years of age similar to men. No consensus was achieved regarding lowering the threshold for AAA repair and the need for deep venous thrombosis prophylaxis in patients undergoing EVAR. CONCLUSIONS: This expert-based Delphi Consensus document provides guidance for clinicians regarding specific unresolved issues. Consensus could not be achieved in some topics, highlighting the need for further research in those areas.

Endovascular repair of pararenal and thoracoabdominal aortic aneurysms with inner and outer off-the shelf-multibranched endografts. A systematic review and meta-analysis.

BACKGROUND: During the last years a great progress has been noted in device technology and operator experience in treating complex aortic aneurysms. Fenestrated and branched custom-made devices require detailed preoperative planning and production time that can take up to 12 weeks. During this awaiting period, the aortic related mortality is being increased. To overcome this limitation, off-the shelf standardized multibranched devices were launched in the market for the treatment of pararenal and thoracoabdominal aortic aneurysms (TAAA). Our aim was to systematically evaluate all the published studies of off-the shelf endografts for the treatment of pararenal and thoracoabdominal aortic aneurysms. METHODS: We performed a systematic review to identify all the eligible studies that reported outcomes to the off-the-shelf with inner or outer multibranched devices and then conducted a qualitative synthesis and meta-analysis of the results. The main outcomes were technical success, mortality, target visceral vessel (TVV) instability, major adverse events and reintervention rate. We estimated pooled proportions and 95% confidence intervals (CIs). RESULTS: A total of 1605 study titles were identified by the initial search strategy, of which 13 (8=t-Branch/ 3=E-nside/1=We-Flow/1=TAMBE) were considered eligible for inclusion in the meta-analysis. A total of 595 patients (70% male) were identified among the eligible studies. In terms of procedures, 64.4% were elective, 19.2% (13.4% outer-multibranched group (OMG); 6.1% inner-multibranched group (IMG) were emergent, and 16.4% (15.6% OMG; 0.8% IMG) were urgent. The pooled technical success was 92.1% (95%, CI, 83.8-96.4%) and 96.9% (95%, CI, 92.5-98.8%) for the outer- and inner-multibranched endograft, respectively. The pooled 30-day mortality was 10.4 % (95%, CI, 6.6-16.1%,) and 4.2% (95%, CI, 2.0-8.6%) for the outer and inner branched group respectively. The pooled 30-day and late TVV instability for the outer-branched group was 3.5% (95%, CI, 2.0-6.1%) and 6.2% (95%, CI, 4.7-8.0%) and for the inner branched group 10.4% (95%, CI, 4.5-22.5%) and 1.6% (95%, CI, 0.7-3.3%) respectively. CONCLUSIONS: This pooled analysis indicated good technical success and mortality rate, for both devices despite the high rate of urgent procedures. Pararenal and thoracoabdominal aortic aneurysms can be safely treated using the included devices. However, further studies are required to draw additional conclusions for the inner group due to the small sample size.

Reintervention Rate after Treatment with the INCRAFT AAA Ultra-Low-Profile Stent Graft System.

BACKGROUND: The INCRAFT stent graft system is an ultra-low-profile endograft for the exclusion of infrarenal aortic aneurysms. In the market approval studies, an increased rate of device-related complications was observed and the endograft was approved with mandated postmarketing investigations. Our aim was to analyze mid-term outcomes of a real-world patient cohort treated with the INCRAFT endograft. METHODS: Consecutive patients treated with the INCRAFT endograft between February 2015 and December 2022 at a single institution were included. In accordance with the Society for Vascular Surgery reporting standards, safety endpoints were reported and outcome endpoints included reinterventions, technical success, aortic-related and overall-mortality, endoleak, stent fracture, and endograft migration >5 mm. RESULTS: Eighty patients (85% male) with a mean age of 76 ± 7 years were included. Fifty-two patients (65%) were treated within the endograft's instruction for use. Mean aortic diameter was 59 ± 10 mm and 91% of the procedures were performed percutaneously. Mean follow-up (FU) was 37 ± 25 months and there was no aortic- or procedure-related mortality. Reinterventions occurred in 25 patients (31%) with a freedom from reintervention at 1, 3, and 5 years of 84%, 66%, and 55%. The most frequent reinterventions were limb graft stenting (23%) and type II endoleak embolization (14%). Limb occlusion rate was 9% and in 3 patients (4%) distal endograft migrations >5 mm occurred. Persisting type II endoleaks were observed in 29% and aneurysm diameter was stable in 41% and had shrunk in 38%. Three type III endoleaks (4%) developed during FU and 4 open conversions (5%) were necessary. No known risk factors, including treatment outside instruction for use, were predictive for reinterventions. CONCLUSIONS: Treatment of infrarenal aortic aneurysms with the INCRAFT stent graft system was safe and successful. Nevertheless, a substantial rate of reinterventions was necessary during FU to maintain endograft patency and prevent aneurysm growth.

Indication and Outcome of Late Open Conversion after Abdominal Endovascular Aortic Repair.

BACKGROUND: Endovascular aortic repair (EVAR) has become the standard of care for patients with infrarenal aortic aneurysms over the last 2 decades. Endograft technology and treatment of complications like endoleaks, graft migration, or graft occlusion developed over time. However, sometimes open surgical conversion maybe required. Our aim was to analyze the indications, the technical aspects and outcomes in patients who underwent open conversion after EVAR with different types and generations of endografts. METHODS: This retrospective single-center study reviewed all patients who underwent EVAR from 2004 to 2020. Open surgical conversions >1 month post EVAR were identified. Conversions for graft infection were excluded. Indications for conversion and operative technique were analyzed. Primary endpoint of the study was 30-day mortality. Secondary endpoints were re-interventions and follow-up mortality. RESULTS: During 2004 and 2020, 443 consecutive EVARs were performed, and 28 patients required open surgical conversion, with an additional 3 referred from other hospitals (N = 31). The median age was 75 (range 58-93); 94% were male. Conversion was performed after a median time of 55 months (range 16-209). Twenty patients underwent elective and 11 emergency conversion. Indications for open conversion were graft migration, respectively, disease progression with endoleak type Ia and/or Ib in 52% (16/31) and sac expansion due to endoleak type II in 26% (8/31). Of the 31 patients, 17 (55%) had at least one previous endovascular re-intervention. All patients met the device-specific instructions for use for each implanted endograft. In-hospital intervention rate was 16% (5/31). Thirty-day mortality rate was 3% (1/31) with one patient died due to multiorgan failure after rupture with complete endograft replacement. Five patients (16%) died during follow-up. Mid-term follow-up was 47.5 months (range 24-203) with estimated cumulative survival rates of 97%, 89%, and 84%, at 1, 3, and 5 years, respectively. CONCLUSIONS: Late open conversion remains a valuable treatment option and can be performed safely in elective and emergency setting with a low early mortality. Lifelong surveillance and prompt intervention when necessary are essential in ensuring optimal outcomes after EVAR and preventing the need for emergent conversions.

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

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

Post hoc analysis of the SuperB and Zilverpass trials for treatment of long and complex superficial femoral artery lesions.

OBJECTIVE: In two randomized controlled trials, the outcomes of endovascular treatment of complex femoropopliteal arterial lesions were compared with bypass surgery and considered a valid alternative treatment. The aim of this study was to compare both endovascular treatment options with the hypothesis that implantation of heparin-bonded self-expanding covered stents (Viabahn [SECS]) or drug-eluting stents (ZilverPTX [DES]) are related to similar clinical outcomes at 1-year follow-up. METHODS: In a post-hoc analysis, the SuperB trial and Zilverpass databases were merged. Patients in the endovascular treatment arms were included, and data was analyzed in an intention-to-treat (ITT) and a per-protocol (PP) fashion. Data included baseline and lesion characteristics, procedural details, and follow-up data. The primary endpoint of this study was primary patency at 1-year follow-up. The secondary endpoints were secondary patency, target lesion revascularization (TLR), limb loss, and all-cause mortality. RESULTS: A total of 176 patients were included; 63 in the SECS arm and 113 in the DES arm. Through 1-year follow-up, there were no significant differences in primary patency (ITT: 63.4% vs 71.1%: P = .183 and PP: 60.8% vs 71.1%; P = .100). Secondary patency rates were not significantly different in the ITT analysis (86.5% vs 95.1%; P = .054), but in the PP analysis, there was a significant difference in favor of the DES group (SECS, 85.6% vs DES, 95.1%; P = .038). There was no significant difference in freedom from TLR between groups (79.6% vs 77.0%; P = .481). No major amputations were performed in the SECS group, and two were performed in the DES group (1.8%). Survival rate was 98.2% in the SECS group, and 91.3% in the DES group after 1-year follow-up (P = .106). Based on diagnosis (intermittent claudication vs chronic limb-threatening ischemia) no differences between patients with intermittent claudication and chronic limb-threatening ischemia were observed in primary patency, secondary patency and freedom from TLR. CONCLUSIONS: Treatment of complex femoropopliteal arterial disease with the heparin-bonded Viabahn endoprosthesis and the Zilver PTX drug-eluting stent are related to similar primary and secondary patency, and TLR rates at 1 year, except for secondary patency in the PP analysis. This study further supports the endovascular treatment of long complex lesions in the femoropopliteal artery.