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To verify the anatomical basis, ideal puncture sites, and potential pitfalls of the distal radial artery (dRA) in the anatomical snuffbox region for distal radial access (dTRA).
Overall, 26 formalin-fixed upper limbs and computed tomography angiography (CTA) of the upper limbs of 168 consecutive patients were studied. Cadaveric dissection and dRA 3D reconstruction were used to evaluate the dRA route for dTRA. The puncture sites, dRA diameter, and angle of the dRA and tendons of the extensor pollicis brevis were also measured in the patients and cadavers.
The cadaver dissection provided more insights than did the dRA 3D reconstruction. However, preoperative evaluation had better diagnostic accuracy (p=0.024). Puncture sites 1 and 3 had a high success rate (63.2% possible success rate, 191/302). The DISFAVOR theory was put forward, in which 8 types of potential pitfalls that may interrupt puncture procedure or lead to a surgical failure were observed, including occlusion, stenosis, tortuosity, arteriovenous fistula, angioma, different radial artery (RA) ramifications, radial veins, and cephalic veins. The mean diameter of dRA based on cadaver dissection and CTA was 2.53 (SD=0.73) and 2.63 (SD=0.69) mm, respectively. Furthermore, the minimum distance from the outer layer of dRA to the skin was 5.71 (SD=2.0) mm based on CTA. The angle between the dRA and tendons of extensor pollicis brevis (TEPB) based on cadaver dissection and CTA was 58.0° (SD=21.5°) and 51.8° (SD=16.6°), respectively.
Puncture sites 1 and 3 were more suitable for the dTRA, and we put forward the DISFAVOR theory to summarize the 8 types of potential pitfalls during the use of dTRA.
Endovascular aneurysm repair (EVAR) has been used worldwide to treat abdominal aortic aneurysms (AAAs). Outcomes after EVAR within and outside the instruction for use (IFU) remain controversial. We analyzed long-term outcomes of EVAR within-the-IFU compared with that outside-the-IFU and baseline clinical/anatomical characteristics that influence outcomes of EVAR.
The study included 546 patients who underwent EVAR for infrarenal AAA from 1997 to 2021 at 2 Korean medical centers. The primary endpoint was graft-related adverse events (GRAEs), including type 1 or 3 endoleak, reintervention (included open conversion), aneurysm sac enlargement, aneurysm-related mortality (ARM), rupture, stent-graft migration, and stent thrombotic occlusion.
The patients who underwent EVAR outside the IFU were 287 (52.6%). A neck angle of >60° was most common outside the IFU criteria (n=146, 50.9%). This study revealed that patients outside the IFU had a higher rate of GRAEs compared with patients within the IFU (hazard ratio [HR]: 1.879; 95% confidence interval [CI]: 1.045–2.386). A neck angle of >60° was a significant risk factor for GRAEs (adjusted HR: 2.229; 95% CI: 1.418–3.503), type 1 or 3 endoleak (adjusted HR: 2.640; 95% CI: 1.343–5.189), and reintervention (adjusted HR: 1.891; 95% CI: 1.055–3.388).
Our study revealed EVAR with outside the IFU was associated with increased GRAEs, mainly attributed to endoleak and ARM, compared with EVAR with within the IFU. In addition, severe neck angulation was an independent risk factor for GRAEs, type 1 or 3 endoleak, and reintervention.
Our study revealed endovascular aneurysm repair (EVAR) with outside-the-instruction for use (IFU) was associated with increased graft-related adverse events (GRAEs) compared with EVAR with within-the-IFU. In the low-risk population, the incidence of GRAEs and Aneurysm related mortality were higher in the outside-the-IFU group rather than within-the-IFU group. In addition, severe neck angulation was an independent risk factor for GRAEs, type 1 or 3 endoleak and reintervention.
Subacute massive pulmonary embolism is an uncommon manifestation of severe pulmonary embolism associated with poor prognosis. Given the chronicity of the thrombi, standard medical treatment may not be effective. We present a case where mechanical thrombectomy using thromboaspiration catheter was effective, resulting in clinical improvement following the extraction of a large amount of thrombus.
Mechanical thrombectomy using a thromboaspiration catheter can be an effective alternative in the treatment of subacute pulmonary embolism.
The study aimed to compare the effectiveness of drug-coated balloon (DCB) and drug-eluting stents (DESs) to standard endovascular techniques like percutaneous transluminal angioplasty (PTA) and bare metal stent (BMS) for treating infrapopliteal artery disease.
Including 8 DCB trials and 4 DES trials, this meta-analysis of 12 recent randomized controlled trials (RCTs) is comprehensive. We searched MEDLINE, EMBASE, Science of Web, Cochrane, and PubMed for this meta-analysis. We searched these databases for papers from their inception to February 2023. We also analyzed the references given in the listed studies and any future study that cited them. No language or publication date restrictions were applied to the 12 RCTs. The experimental group includes 8 DCB studies and 4 DES investigations, the DCB group is primarily concerned with the paclitaxel devices, whereas the DES group is preoccupied with the “-limus” devices. Key clinical outcomes in this study were primary patency and binary restenosis rates. This study’s secondary outcomes are late lumen loss (LLL), clinically-driven target lesion revascularization (CD-TLR), limb amputation, and all-cause mortality. The evidence quality was assessed using Cochrane risk-of-bias. The PROSPERO registration number for this study is CRD42023462038.
Only 108 of 1152 publications found satisfied qualifying criteria and contained data. All 13 RCTs have low to moderate bias. Drug-coated balloons and DESs were compared in the excluded study. The analysis comprised 2055 participants from 12 RCTs that met the inclusion criteria, including 1417 DCB patients and 638 DES patients. Drug-coated balloons outperform traditional methods in short-term monitoring of primary patency, binary restenosis, and CD-TLR. The benefits fade over time, and the 2 techniques had similar major amputation rates, mortality rates, and LLL. Drug-eluting stents outperform conventional procedures in primary patency, binary restenosis, and CD-TLR during medium-term to short-term follow-up. Comparing the 2 methods, major and minor amputations, death rate, and LLL were similar.
Comparison of DES and DCB with PTA or BMS shows that DES had better follow-up results. DCB has positive short-term results, but long-term effects differ, however, more research is needed to determine when DES and DCB should be used in medical procedures.
The provision of additional evidence to substantiate the advancement of drug-coated balloon (DCB) therapy in the treatment of lower limb arteriosclerosis obliterans, particularly in the below-the-knee area characterized by high calcium load and significant occlusion, is comparable in efficacy to conventional procedures. This finding is advantageous for the progress of interventional revascularization. The advancement and efficacy of DCB have resulted in improved treatment outcomes for medical practitioners in clinical settings. Our research incorporates the most recent randomized experiments.
Blunt thoracic aortic injury (BTAI) represents a potentially life-threatening condition and thoracic endovascular aortic repair (TEVAR) is recommended as the first-line treatment (Class I level of evidence C) by the current guidelines. The aim of this systematic review was to determine the perioperative and mid-term follow-up outcomes of patients with BTAI treated with TEVAR.
We reviewed the English literature published between 2000 and 2022, via Ovid, using MEDLINE, EMBASE, and CENTRAL databases, until July 30, 2022. Observational studies and case series, with ≥5 patients, reporting on the perioperative and follow-up outcomes of patients who underwent TEVAR for BTAI were included. The Newcastle-Ottawa Scale was used to assess the risk of bias. Primary outcomes were technical success and 30-day mortality, cerebrovascular morbidity. Secondary outcomes were mortality and re-interventions during the mid-term follow-up.
From 5201 articles identified by the literature search, 35 eligible studies were included in this review. All studies had a retrospective study design. In total, 991 patients were included. The mean age was 34.5±16.5 years (range=16–89 years). Technical success was 98.0% (odds ratio [OR], 95% confidence interval [CI]=0.98, 0.99, p<0.001,
Thoracic endovascular aortic repair showed high technical success and low early cerebrovascular morbidity and mortality rates. In the mid-term follow-up, the estimated mortality and re-intervention rates were also low. Furthermore, higher quality prospective studies are needed.
Thoracic endovascular aortic repair (TEVAR) is recommended as the first line treatement in patients with blunt thoracic aortic injuries (BTAI). This systematic review of 35 retrospective studies and 991 patients showed high technical success (98.0%) with an associated 30-day mortality at 5.0% and low spinal cord ischemia (1%) and stroke rates (2.0%). Mid-term mortality and re-intervention rates reassure the effectiveness of TEVAR in BTAI cases.
Comparative effectiveness of fenestrated endovascular aneurysm repair (FEVAR) and chimney graft endovascular aneurysm repair (ChEVAR) for juxtarenal aortic aneurysms (JAAs) remains unclear. Our objective was to identify and analyze the current body of evidence comparing the effectiveness of both techniques for JAA.
We performed a systematic review and meta-analysis comparing the effectiveness of FEVAR and ChEVAR for JAA repair. We searched MEDLINE, EMBASE, and Cochrane Register for Controlled Trials from January 1, 1990, for randomized and non-randomized studies assessing outcomes of FEVAR and ChEVAR for JAA repair. Screening, data extraction, risk of bias assessment, and GRADE (Grading of Recommendations, Assessments, Development, and Evaluations) certainty of evidence were performed in duplicate. Data were pooled statistically where possible.
Nine retrospective cohort studies comparing the use of FEVAR and ChEVAR for juxtarenal aneurysm were included for meta-analysis. The FEVAR and ChEVAR arms of the meta-analysis consisted of 726 participants and 518 participants, respectively. There were 598 (86.8%) and 332 (81.6%) men in each arm. The mean diameter was larger in the ChEVAR arm (59 mm vs 52.5 mm). Both techniques had similar rates of postoperative 30-day mortality, 3.38% (8/237) versus 3.52% (8/227), acute kidney injury, 16.76% (31/185) versus 17.31% (18/104), and major adverse cardiac events, 7.30% (46/630) versus 6.60% (22/333). The meta-analysis supported the use of FEVAR for most outcomes, with significant advantage for technical success (odds ratio [OR]: 3.24, 95% CI: 1.24–8.42) and avoidance of type 1 endoleak (OR: 5.76, 95% CI: 1.94–17.08), but a disadvantage for spinal cord ischemia (OR: 10.21, 95% CI: 1.21–86.11), which had a very low number of events. The quality of evidence was “moderate” for most outcomes.
Both endovascular techniques had good safety profiles. The evidence does not support superiority of either FEVAR or ChEVAR for JAA.
While lack of equipoise has hampered the design of randomised trials of open versus endovascular repair of juxtarenal aortic aneurysms, concern about the durability of endovascular repair highlights the need for stronger evidence of the comparative efficacy of endovascular techniques. This review performed meta-analysis and evidence appraisal of recent data from large observational studies comparing fenestrated and chimney techniques, using a comprehensive outcome set. Superiority of either intervention could not be established due to differences in participants’ baseline risk in each study arm. However, data suggests that both techniques are safe and suitable for use when indicated.
Lower limb complex arterial obstructions can be difficult to treat by standard endovascular means. Different technical strategies, such as the retrograde puncture of below-the-knee (BTK) vessels, the plantar loop technique, or the transcollateral approach, have been described to approach BTK or below-the-ankle (BTA) chronic total occlusions after a failed antegrade recanalization attempt. However, when the disease progresses into the foot or the plantar arch cannot be crossed for a bidirectional approach, the necessity for mastering extreme distal punctures increases. This review is to summarize different tips and tricks to help operators apply them when facing these complex punctures.
When the standard endovascular crossing maneuvers have failed during CLTI recanalization procedures and the distal below-the-knee or proximal below-the-ankle retrograde access is not possible due to chronic occlusion of the vessels, mastering the more distal and complex retrograde BTA punctures may be advantageous.There are scanty reports regarding the retrograde puncture of the mid and forefoot vessels. The aim of this article is to review different tips and tricks related to these techniques to help operators to apply them in specific scenarios to eventually improve procedural success rate.
This study aimed to assess the efficacy and safety outcome of covered stents (CSs), as compared with bare-metal stents (BMSs), for the treatment of patients with aortoiliac occlusive disease (AIOD).
A systematic literature search was conducted in PubMed, Embase, and Cochrane Library up to August 2023 to identify all studies comparing efficacy and safety outcomes of CSs versus BMSs for treating AIOD. Our outcome was primary patency, secondary patency, technical success, ankle-brachial index (ABI) variation, target lesion revascularization (TLR), limb salvage, complications, and long-term survival. Dichotomous outcomes were pooled as relative risks (RR) or hazard ratio with the 95% confidence interval (CI). Continuous outcomes were pooled as weighted mean differences and 95% CI. Model selection was based on the heterogeneity of the included studies.
There were 10 studies (2 randomized controlled trials, 8 retrospective cohort studies), comprising 1676 sample size. Compared with BMSs, CSs use was associated with better primary patency of patients with a Trans-Atlantic Inter-Society Consensus II (TASC) D lesion (RR, 1.15, 95% CI, 1.04 to 1.27, p=0.007), TLR (RR, 0.39, 95% CI, 0.27 to 0.56, p<0.001), technical success (RR, 1.01, 95% CI, 1.00 to 1.02, p=0.010), and long-term survival (RR, 1.06, 95% CI, 1.01 to 1.11, p=0.020). There is no difference between CSs and BMSs regarding primary patency of all patients, secondary patency, variation in ABI, limb salvage, and complications.
Compared with BMSs, CSs used in AIOD was associated with more favorable primary patency in patients with TASC D lesions, TLR, technical success rates, and patient long-term survival. These results provide evidence of the advantages of using CSs for AIOD treatment. Future studies focusing on long-term variations in ABI, primary patency of different degrees of calcification, vascular segments, and TASC classification are warranted.
Although several studies evaluated the clinical efficacy of CS in the context of AIOD treatment, the significance and consistency of these findings were not determined to date. We found that CS was used in AIOD associated with better technical success rate, long-term patient survival, lower target lesion revascularization, and higher primary patency of patients with a Trans-Atlantic Inter-Society Consensus II D lesion when compared with BMSs. Our study provides evidence supporting the superiority of CSs over BMSs in the treatment of AIOD, and furnishing clinicians with guidance for treatment decisions.
The purpose of this study is to assess the efficacy and safety of cilostazol prescription in patients with femoropopliteal peripheral artery disease (PAD) after endovascular therapy (EVT).
We conducted a systematic review and meta-analysis of all studies reporting the outcomes of cilostazol after femoropopliteal EVT of PAD up to September 2022. Clinical outcomes of interest included primary patency, in-stent restenosis (ISR), vessel re-occlusion, freedom from target lesion revascularization (TLR), repeat revascularization, all-cause mortality, amputation, major adverse cardiovascular events (MACEs) and major adverse limb events (MALEs), and bleeding complication.
A total of 4 randomized controlled trials (RCTs) and 8 observational studies containing a total of 4898 patients met the inclusion criteria and were included in this systematic review and meta-analysis. We found that the use of cilostazol was associated with higher primary patency after femoropopliteal artery EVT (odds ratio [OR]=1.67, 95% confidence interval [CI]=1.50-1.87, p<0.001, I2=33.2%), a lower risk of ISR (OR=0.43, 95% CI=0.29-0.63, p<0.001, I2=37.6%), repeat revascularization (OR=0.43, 95% CI=0.24-0.76, p<0.005, I2=27.4%), and vessel re-occlusion (OR=0.59, 95% CI=0.38-0.93, p<0.05, I2=0%). There was an increase in freedom from TLR rate (OR=2.19, 95% CI=1.58-3.05, p<0.001, I2=0%), as well as a reduction in the occurrence of MALEs (OR=0.50, 95% CI=0.29-0.85, p<0.05, I2=0%). However, there was no significant difference in amputation, MACEs, all-cause mortality, and major bleeding complications. Subgroup analysis showed that cilostazol treatment in patients with femoropopliteal drug-eluting stents (DES) implantation remained associated with higher primary patency and a lower risk of ISR.
After EVT of femoropopliteal artery lesions, additional oral cilostazol enhances primary patency, reduces the occurrences of ISR and vessel re-occlusion, diminishes the risks associated with MALEs, lowers the need for repeat revascularization, and increases freedom from TLR rates. However, it does not impact amputation, MACEs, all-cause mortality, or major bleeding complications. These findings suggest cilostazol as a potentially safe and effective adjunct therapy in patients with femoropopliteal PAD after EVT.
After undergoing endovascular therapy (EVT) for femoropopliteal artery lesions, the addition of cilostazol to antiplatelet therapy can significantly improve primary patency, reducing the incidence of in-stent restenosis, repeat revascularization, vessel re-occlusion, and major adverse limb events while increasing freedom from target lesion revascularization rate. The simultaneous use of drug-eluting stents in the femoropopliteal artery lesions, combined with cilostazol, potentially results in a synergistic anti-stenotic effect. This therapeutic approach does not appear to be associated with an increased risk of major bleeding events or all-cause mortality. These findings provide additional evidence supporting the treatment of anti-stenosis in patients with femoropopliteal artery lesions after EVT.
This systematic review aimed to summarize the effectiveness and safety of endoanchor, a stabilizing device for the proximal endograft designed to prevent endoleak and stent migration in endovascular aneurysm repair (EVAR) and thoracic endovascular aneurysm repair (TEVAR).
A systematic review and meta-analysis was conducted per the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) guideline. Literature up to May 31, 2023 was searched and independently screened from 4 databases. Data were pooled for meta-analysis. Primary outcomes included intraoperative and follow-up endoleak, stent migration, and reintervention rates; sac regression; and 30-day all-cause mortality.
Sixteen EVAR (n=1145) and 6 TEVAR studies (n=163) using the Heli-Fx EndoAnchor system were included from 2225 retrieved records. For EVAR patients (mean follow-up=11.9 months), the endoleak, graft migration, and reintervention rates were 3.97% (95% confidence interval [CI]=0.36%-1.99%), 0.004% (95% CI=0.00%-0.76%), and 5.43% (95% CI=0.86%-12.54%), respectively. The endoleak rates for primary and revision EVAR were 0.16% (95% CI=0.00%-1.65%) and 3.60% (95% CI=0.14%-9.72%), respectively. Only 4 cases of 30-day mortality (n=4) were reported in the literature. For TEVAR patients, the endoleak, stent migration, and reintervention rates were 7.4% (95% CI=0.03%-0.13%), 0.2% (95% CI=0.00%-0.06%), and 17.1% (95% CI=0.01%-0.45%), respectively. The 30-day mortality was 0.9% (95% CI=0%-0.12%).
Endoanchor fixation in EVAR and TEVAR is effective and safe in preventing and treating endoleak and stent migration. The mortality is minimal in EVAR but higher in TEVAR.
Endoleak, graft migration, and reintervention in EVAR and TEVAR with endoanchor use were rare. Mortality in EVAR was low. The adjunctive deployment of endoanchors is an effective and safe means to prevent and treat endoleak and stent migration in EVAR and TEVAR. Yet, long-term efficacy and safety data and randomized controlled trials would be required to definitively recommend endoanchor use in routine clinical practice.
The optimal approach for pediatric ostium secundum atrial septal defect (ASD) closure remains uncertain. This study aims to assess complications and efficacies of surgical and transcatheter closures.
Systematic search in Medline, Cochrane, and EMBASE databases identified cohort studies until July 2023. Complications, length of hospital stay, and efficacy outcomes were evaluated. Subgroup analyses considered ethnicity, ASD size, age, and rim deficiency involvement.
Fourteen cohort studies involving 9695 patients were comprehensively analyzed. Regarding complications, the pediatric patients in the surgery group exhibited higher occurrences of cardiac arrhythmia (odds ratio [OR]: 1.87, 95% confidence interval [CI]: 1.22–2.87, p=0.004), pericardial effusion (OR: 14.80, 95% CI: 6.97–31.43, p<0.00001), and pulmonary complications (OR: 2.58, 95% CI: 1.73–3.85, p<0.00001) compared with those in the transcatheter group. However, no significant difference in fever incidence was observed (OR: 2.57, 95% CI: 0.90–7.34, p=0.08). Furthermore, length of hospital stay was notably shorter in the pediatric transcatheter group (mean difference [MD]: 4.00, 95% CI: 1.71–6.29, p=0.0006). Regarding efficacies, both groups demonstrated similar rates of successful closure (OR: 1.97, 95% CI: 0.56–6.92, p=0.29) and residual shunting (OR: 0.55, 95% CI: 0.17–1.77, p=0.31) in the pediatric cohort. Subgroup analyses revealed that surgical residual shunting was notably lower in the European pediatric population (OR: 0.18, 95% CI: 0.07–0.45, p=0.0002), in cases with ASD size exceeding 15 mm (OR: 0.19, 95% CI: 0.08–0.49, p=0.0006), and in pediatric patients younger than 8 years (OR: 0.33, 95% CI: 0.12–0.92, p=0.03). Interestingly, residual shunting involving complex ASD with rim deficiency was more pronounced in the surgery group (OR: 2.66, 95% CI: 1.33–5.32, p=0.006).
Both surgical and transcatheter closures are equally effective, with transcatheter closure showing significantly fewer complications.
This meta-analysis offers pivotal insights for clinicians grappling with the optimal approach to pediatric ostium secundum ASD closure. The observed higher incidence of cardiac arrhythmias, pericardial effusions, and pulmonary complications in surgical closures underscores the challenges associated with this modality. In contrast, transcatheter closure, with its comparable efficacy and shorter hospital stays, emerges as an appealing and less invasive alternative. These findings equip clinicians with evidence to make informed decisions, optimizing patient outcomes. Subgroup analyses further refine recommendations, emphasizing tailored considerations for European pediatric patients, larger ASDs, and those under 8 years old, ultimately fostering personalized and improved care strategies.
Endovascular aneurysm repair using iodinated contrast agents risks contrast-induced nephropathy, especially in high-risk patients. This technical note describes a contrast-free endovascular aneurysm repair (EVAR) protocol using preoperative imaging measurement and fibrin sealant (FS) filling.
Preoperative imaging measurement and intraoperative guidewire manipulation facilitated anatomical identification without contrast. After endograft deployment, the aneurysm sac was filled with FS if endoleak was indicated by pressure fluctuations.
Between 2017 and 2020, 6 high-risk patients underwent contrast-free EVAR with FS filling. Complete exclusion was achieved in all cases. Over follow-up, no endoleaks, deterioration in renal function, or other complications were observed.
Contrast-free EVAR with FS filling shows early feasibility as an alternative technique for contrast-induced nephropathy (CIN) high-risk patients, while larger studies with long-term monitoring are imperative to validate outcomes.
This study showcases a contrast-free EVAR technique with fibrin sealant filling for high-risk CIN patients. It offers a safer approach for those with renal challenges, reducing CIN risk. The technique’s feasibility in a small cohort suggests its utility in treating AAA without iodinated contrast, crucial for patients with specific health risks. For clinicians, it introduces a method that decreases nephrotoxic risks, potentially changing practice for vulnerable patients
Endovascular repair of chronic post-dissection thoraco-abdominal aortic aneurysms (PD-TAAA) presents specific technical challenges due to the presence of chronic septum. Small true lumen diameter and false lumen visceral vessel origin can make branched endograft prohibitive. Septotomy may allow to overcome these challenges in cases of high complex anatomy.
We describe the application of electrocautery septotomy to the visceral aorta segment to deploy an off-the-shelf branched endograft in a chronic PD-TAAA rupture with true lumen collapse.
Electrocautery septotomy can be an effective adjunctive technique to facilitate branched endograft, overcoming technical challenges associated with the endovascular treatment of chronic PD-TAAA.
Electrocautery septotomy is an adjunctive technique that can facilitate endovascular treatment of post-dissection thoraco-abdominal aneurysm. By creating a common lumen, this technique might reduce the number of re-interventions associated with PD-TAAA endovascular exclusion.
To present a novel technique that enables safe and effective cannulation of target vessels with challenging anatomy during fenestrated/branched endovascular aortic repair (F/B-EVAR).
Following deployment of the F/B-EVAR endograft, the target vessels (TVs) are cannulated. The
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Drug-coated balloon (DCB) has been established as first-line therapy in femoropopliteal (FP) intervention, and successful vessel preparation (VP) is considered a key element. However, the clinical impact of successful VP remains unknown. This retrospective study examined the clinical impact of successful VP in DCB FP intervention.
In total, 268 patients (308 limbs) who underwent successful FP intervention using DCB without atherectomy devices for symptomatic lower extremity artery disease between March 2018 and December 2019 were included in this study (high-dose DCB: 69.8%; low-dose DCB: 30.2%). Successful VP was defined as <50% residual stenosis and <dissection grade D before DCB (the successful VP group). The primary outcome measure was primary patency, and its associated factors were evaluated.
The median follow-up period was 2.1 (interquartile range=1.1-2.7) years. Successful VP was achieved in 163 patients (60.8%). Primary patency and freedom from clinically-driven target lesion revascularization (CD-TLR) were significantly higher in the successful VP group than in the nonsuccessful VP group (54.2% vs 33.0%, p<0.001; 69.9% vs 57.7%, p=0.047). In the successful VP group, high-dose DCB and low-dose DCB were comparable in primary patency and freedom from CD-TLR (53.2% vs 53.6%, p=0.48; 68.7% vs 70.9%, p=0.69). In nonsuccessful VP group, high-dose DCB demonstrated numerically higher primary patency but not statistically significant than low-dose DCB (44.5% vs 16.0%, p=0.06), whereas no significant difference in freedom from CD-TLR was observed (56.0% vs 58.9%, p=0.29). On multivariate analysis, successful VP and preballoon size to reference vessel diameter ratio were significantly associated with primary patency.
Achieving successful VP before DCB was independently associated with primary patency in DCB FP intervention.
This study revealed that the successful vessel preparation (VP) before DCB and preballoonsize to reference vessel diameter ratio were independently associated with primary patency in DCB femoropopliteal intervention. When successful VP was achieved only before DCB treatment, the clinical outcomes were comparable between high-dose DCB and low-dose DCB at midterm follow-up.To maximized DCB efficacy, successful VP is very important in daily clinical practice.
This article aims to evaluate the short-term and mid-term performance of a self-expanding covered stent (COVERA Plus, Bard Tempe, Arizona) during the treatment of Trans-Atlantic Inter-Society Consensus (TASC) C/D aortoiliac obstructive lesions involving the aortic bifurcation.
A single-center retrospective review of all patients who underwent endovascular reconstruction of the aortoiliac bifurcation for obstructive disease, with the use of Covera, from January 2018 to March 2023. All patients received a postoperative CTA (computed tomography angiography) scan within 1 month from the intervention. Precision of deployment, stent conformation, and stent symmetry were evaluated at the arterial phase of the CTA. Early outcomes were technical success and freedom from open aortic reintervention and/or mortality. Late outcomes were primary and assisted primary patency rates and freedom from reintervention.
During the study period, 35 patients underwent primary endovascular treatment of obstructive lesions involving the aortic bifurcation with parallel COVERA stents. Aortoiliac lesions were classified as TASC-IIC in 23 (65.7%) patients and TASC D in 12 (34.2%). Median follow-up was 49 months (interquartile [IQR]: 18–60). Overall survival was 97.1% (95% confidence interval [CI]=91–100) at 60 months. During follow-up, there were one early stent stenosis, treated with an angioplasty and stent relining with an estimated primary patency at 60 months of 97.1% (95% CI=94–100) and a primary-assisted patency of 100%. Estimated freedom from all types of reinterventions at 60 months was 94.3% (95% CI=89–99.3).
The new self-expanding covered Bard COVERA Plus stent used for endovascular treatment of TASC C/D aorto iliac disease proved to be safe and feasible with high technical procedural success rates. Comparison with other types of stents is necessary to further assess the role of the COVERA Plus stent in aortic bifurcation repair.
This study investigates the safety and feasibility of the new self-expanding covered Bard Covera Plus stent used for endovascular treatment of TASC C/D aorto iliac disease. The retrospective analysis of 35 patients highlights high technical success and primary patency rate at 60 months. The geometric analysis also helped to underline how this stent can be used precisely in particular conditions. These findings suggest the need for further research to compare COVERA with other types of stents in aortic bifurcation repair.
The upside-down configuration of a Gore Excluder contralateral leg endoprosthesis has been used to overcome diameter differences in the endovascular treatment of aortoiliac aneurysms. Our goal was not to describe the technique but to study the applicability and safety.
Patients were retrospectively enrolled. The indication and details of the procedure were at the discretion of the treating physicians. A case report form was completed including baseline characteristics, indication for treatment, procedural data, and outcomes during follow-up.
A total of 31 subjects were enrolled with a range of indications, including 3 patients treated in the emergency setting (9.7%). In 64.5% (n=20), it was a primary intervention for a common iliac aneurysm (n=10), internal iliac aneurysm (n=4), or abdominal aortic aneurysm (n=6). In 11 subjects (35.5%), treatment was performed after previous aortoiliac interventions, including anastomotic iliac artery aneurysm (n=5), type III endoleak (n=3), and endograft thrombus (n=3). Median follow-up was 13 months (range=1-142 months). During follow-up, 2 patients required an upside-down contralateral leg–related secondary intervention, one for an occlusion and another for a type Ia endoleak. There was no type Ib or III endoleak, and no migration, kinking/stenosis, or conversion to open repair was observed. The aneurysm-related mortality was 3.3% (n=1).
An upside-down contralateral leg is a valuable technique that can be used to achieve adequate aneurysm exclusion or resolve complications. It is associated with a limited number of complications.
This article studies the use of an upside-down iliac endograft. We describe a wide range of indications in which this previously published technique has been applied. In elective and acute settings and as primary and revision intervention an upside-down iliac endograft was performed successfully. Furthermore, follow-up data is presented showing the effectiveness of the technique. Knowledge of this procedure is a valuable addition to the skillset of every interventionalist.
Fenestrated endovascular aneurysm repair (FEVAR) has become one of the standard treatment options for complex abdominal aortic aneurysms (cAAAs) and thoraco-abdominal aortic aneurysms (TAAAs). Despite technological advances in the main endograft design, the lack of dedicated bridging stent-grafts (BSGs) is still the Achilles heel of the procedure. The aim of this study was to evaluate the mid-term outcomes of the BeGraft stent-graft as a dedicated bridging stent for FEVAR and to review the current evidence in literature.
Retrospective single center study, including all consecutive FEVARs performed between September 2018 and December 2022 for the treatment of cAAAs and TAAAs with implantation of at least one BeGraft peripheral as the main BSG in one of the target vessels (TVs). Primary endpoints were technical success and TV instability of TV bridged with a BeGraft stent, as well as 30-day mortality and re-intervention rates. Secondary endpoints were follow-up TV instability, re-interventions, and mortality.
A total of 113 patients (93 male, mean age 71.1±9.7) and 440 TV (14 scallops and 426 fenestrations) were included. Of the 440 TV, 406 received primary stenting. Be Grafts were used in 88.9% of these (n=361; celiac trunk [CT]=67, superior mesenteric artery [SMA]=98, right renal artery [RRA]=97, and left renal artery [LRA]=99). The technical success rate was 99.4% (359/361). The 30-day TV instability rate was 0.27% (1/361) with one early renal artery occlusion. During a median follow-up of 20 months (6-32), TV instability rate was 0.8% (3/361). Freedom from TV instability was 99.3%, 98.8%, and 98.8% at 1, 2, and 3 years, respectively.
Early-term and mid-term results regarding TV instability are satisfactory and support the use of BeGraft as BSG in FEVAR for cAAAs and TAAAs.
The findings of the current study show that the use of the BeGraft stent graft as bridging stent in FEVAR is associated with a high technical success and low early and mid-term instability rate and support the standard use as a bridging stent in fenestrated aneurysm repair.
The aim of this study was to assess whether the ratio of the mean infrarenal neck diameter to the suprarenal aortic diameter is a predictor for a durable proximal seal after endovascular aneurysm repair (EVAR).
A total of 439 patients who underwent elective EVAR between 2004 and 2018 in a single vascular referral center met our inclusion criteria. Ratios were calculated by dividing the mean infrarenal neck diameter by 4 different suprarenal aortic diameters. Patients who developed a late type 1A endoleak (n=20) or proximal neck dilatation mandating revision (n=8) were compared with the 411 patients without long-term proximal seal complications.
Patients who developed a late type 1A endoleak had more frequently hypertension, a shorter infrarenal neck length, and a larger mean infrarenal neck diameter. The ratio of the mean infrarenal neck diameter to all 4 suprarenal aortic diameters was higher in the late type 1A endoleak group compared with the group without a late type 1A endoleak. Least absolute shrinkage and selection operator (LASSO) logistic regression identified a combination of 6 variables as the best combination to predict a late type 1A endoleak: presence of hypertension, increased mean infrarenal neck diameter, decreased aneurysm neck length, larger ratio of the mean infrarenal neck diameter to the aortic diameter proximal to the superior mesenteric artery (SMA), larger ratio of the mean infrarenal neck diameter to the aortic diameter proximal to the upper renal artery, and increased β-angle. Of these, based on both the univariate area under the curve (AUC) and optimal LASSO model restricted to a single predictor, the ratio of the mean infrarenal neck diameter to the aortic diameter proximal to the SMA (AUC, 0.770; cutoff value, 0.997) was considered the best prognostic variable.
The ratio of the mean infrarenal neck diameter to the aortic diameter proximal to the SMA is a good predictor for a late type 1A endoleak. Patients with mean infrarenal neck diameter larger than the diameter proximal to the SMA (ratio >1) are at risk for a late type 1A endoleak.
In this single-center, retrospective cohort study, we found that the ratio of the mean infrarenal neck diameter to the aortic diameter proximal to the SMA is a good predictor for a late type 1A endoleak. We conclude that the suprarenal diameter must be taken into account before assessing endovascular aortic aneurysm repair eligibility. Patients with a ratio >1 may not be the best candidates for a durable result after EVAR and may be better off with fenestrated EVAR or open repair.
The aim of this study is to share preliminary experiences and outcomes with a novel custom-made fenestrated TREO® Abdominal Stent-Graft System to treat juxtarenal and pararenal abdominal aortic aneurysms (AAAs).
Juxtarenal and pararenal AAA patients treated with the custom-made fenestrated TREO® Abdominal Stent-Graft System were included from 4 high-volume European academic medical centers from June 2021 to September 2023. Technical success and 30-day/in-hospital mortality and complications were analyzed. Technical success was defined as successful endovascular implantation of the stent graft with preservation of antegrade flow to the target vessels, and absence of type 1 or 2 endoleak (EL) at the first postoperative computed tomography angiography (CTA).
Forty-two consecutive patients were included. The majority of the devices were constructed with 2 (N=4; 9.5%), 3 (N=9; 21.4%), or 4 (N=27; 64%) fenestrations. In 1 case, the device was constructed with a single fenestration (2.4%) and 1 device contained 5 fenestrations (2.4%); 17% had previous AAA repair. Target vessel cannulation with placement of a bridging stent was successful in all but 1 vessel (99, 3%). One aneurysm-related death occurred in the direct postoperative period and 2 limb occlusions necessitated reintervention during admission. In the median follow-up period of 101 (2–620) days, 3 more patients died due to non–aneurysm-related causes. Technical success was achieved in 90% of the cases. Nineteen ELs were seen on the first postoperative CT scan: 1 type 1b EL (N=1; 2%), 15 type 2 ELs (N=15; 36%), and 3 type 3 ELs (N=3%). Eleven patients received more than 1 CT scan during a median follow-up of 361 days (82-620): 3 type 2 ELs resolved and 1 type 3 EL was treated in this period. In the follow-up, 1 patient had a coagulation disorder that caused occlusions of the branches.
The results of the first experiences using the custom-made fenestrated TREO® Abdominal Stent-Graft System in Europe are promising. There was a low short-term mortality and morbidity rate in these patients of which 17% had previous AAA repair. Mid-term and long-term follow-up data are needed to evaluate endograft durability and performance.
This study shows the first experiences and short-term results of a novel low-profile custom-made device: the custom-made fenestrated TREO® Abdominal Stent-Graft System. Showing these results and experiences can help the physicians in clinical decision-making for their patients.
The purpose was to investigate outcomes of high-risk patients undergoing thoracoabdominal aortic aneurysm (TAAA) repair using fenestrated or branched endovascular aneurysm repair (F/BEVAR) devices at a single center in Canada.
A retrospective review of all patients undergoing endovascular TAAA repair with F/BEVAR from June 2007 to July 2020. Imaging and clinical endpoints of interest including death, reintervention, and target vessel patency were reported.
Ninety-five consecutive patients underwent endovascular TAAA repair using F/BEVAR stent grafts (63 males, median age 74 [interquartile range 70, 78] years). Repairs included 81 elective and 14 urgent/emergent cases (6 ruptures and 8 symptomatic). Graft deployment was 100% successful. Intraoperative target vessel revascularization was successful in 336/355 (94.6%) vessels with the celiac having the lowest success rate 72/82 (87.8%). In-hospital mortality was 9.5% (7.4% elective and 21.4% urgent/emergent, p=0.125) and permanent paraplegia was 4.2% (3.7% elective and 7.1% urgent/emergent, p=0.458). In-hospital complications included stroke in 5.3%, acute myocardial infarction in 8.4%, and bowel ischemia in 5.3%. No patients required permanent dialysis or tracheostomy during their hospital stay. However, 22 (23.2%) patients required additional unplanned procedures for various indications (branch occlusion, endoleaks, realignment) during their hospital stay. Patients were followed up for a mean of 3.6 ± 3.0 years. Clinical follow-up was 100%, with 80/86 (93%) having surveillance imaging. On follow-up imaging, 43 (50%) patients had at least 1 endoleak identified and 337/341 (98.8%) of the target vessels were found to be patent. At 5 years, cumulative probability of reintervention was 46.3% (95% confidence interval [CI], 36.1-56.4). Survival at 5 and 8 years was 50.1% (95% CI, 38.4-65.4) and 34.4% (95% CI, 22.5-52.8), respectively. Progression of aneurysmal disease leading to rupture on follow-up was confirmed in 1 patient at 10 years.
Endovascular TAAA repair provides a safe treatment option with a high technical success rate and low pulmonary and renal complications. Long-term survival is similar to previous literature; however, high rates of secondary reintervention reaffirm the need for ongoing patient follow-up and further technical improvements.
This study demonstrates that endovascular repair of TAAAs can be performed in a high-risk elderly population with acceptable rates of mortality, TALE and SCI, using evolving technology. The incidences of post-operative respiratory failure and renal dysfunction were lower in patients who underwent endovascular repair compared with open repair. Future technical and procedural refinements in addition to increasing surgical experience are expected to lead to further improvements in short- and long-term outcomes exceeding those of open repair.
This study aims to compare the 5-year outcomes of endoluminal bypass (EB) using heparin-bonded self-expanding covered stents versus bypass surgery for extensive femoropopliteal disease, including technical and clinical outcomes and health status.
The surgical femoropopliteal bypass was the gold standard to treat peripheral arterial disease (PAD) for decades; however, endovascular treatment modalities are now recommended for most femoropopliteal lesions. One-year data of a randomized controlled trial comparing EB with surgical bypass (SB) have shown a faster recovery, less morbidity, and comparable patency rates between the two techniques. To date, long-term randomized controlled data regarding both techniques are lacking.
Five-year results of a multicenter randomized controlled trial comparing EB with SB in patients with femoropopliteal artery disease were evaluated based on intention-to-treat and per-protocol analyses.
At 5-year follow-up, primary, primary-assisted, and secondary patency rates were 36.2%, 52.4%, and 68.1% for EB and 49.4%, 72.2%, and 77.8% for SB, respectively (p=0.608). Freedom from target lesion revascularization (fTLR) was 34.1% for EB and 57.6% for SB (p=0.365). In both groups, the ankle-brachial index, Rutherford classification, and walking distance significantly improved compared with baseline without differences between groups at follow-up. Freedom from major amputation rate was 92.6% in the EB group and 96.2% in the SB group (p=0.361). The 36-Item Short-Form Health Survey showed no significant differences between groups.
Treatment of extensive femoropopliteal disease with self-expanding covered stents provides comparable clinical-related and health-related questionnaire outcomes when compared with SB through 5 years of follow-up. However, the EB is related to a higher number of reinterventions.
This present study is the first to report five-year outcomes comparing an endoluminal (EB) using heparin-bonded self-expanding covered stents with surgical bypass (SB) for long and complex femoropopliteal disease. Although the advantages of treatment with EB are mostly seen in the early period after treatment, the outcomes support the use of EB for this indication and seems to be a valid and safe alternative for bypass surgery. Future trials comparing various endovascular strategies may provide further guidance for the development of an evidence-based treatment algorithm.
Data on target vessel (TV)-related outcomes in patients managed with branched thoracic endovascular aortic repair (BTEVAR) are limited. This study aimed to present the TV-related outcomes of BTEVAR in patients managed for aortic arch pathologies at 30 days and during follow-up.
A retrospective analysis of consecutive patients, managed between September 1, 2011, and June 30, 2022, with custom-made aortic arch endografts (Cook Medical, Bloomington, IN, USA), presenting at least one branch configuration, were eligible. Primary outcomes were technical success, TV-related patency, and reinterventions at 30 days.
In total, 255 TVs were revascularized using branches: 107 innominate arteries (IAs), 108 left common carotid arteries (LCCAs), and 40 left subclavian arteries (LSAs). Covered stents were used as bridging stents of which 10.2% were balloon expandable. Relining, using bare-metal stents (BMS), was performed in 14.0% of IAs, 35.2% of LCCAs, and 22.5% of LSAs. Technical success on case basis was 99.2%; no failure was related to unsuccessful TV bridging. At 30 day follow-up, no TV occlusion was detected. In 5.6% of cases, a type Ic or III endoleak, attributed to TVs, was recorded. Two patients needed early branch-related reintervention. The mean follow-up was 18.3±9.2 months. Freedom from TV instability was 94.6% (standard error [SE] 2.5%] at 12 months. No TV stenosis or occlusion was detected up to 48 months of follow-up. Freedom from TV-related reinterventions was 95.4% [SE 2.4%] at 12 months.
TV stenosis or occlusion in BTEVAR cases is rare and TV-related reinterventions and instability events are mainly attributed to type Ic and III endoleak formation.
Previous studies focusing on target vessel (TV) outcomes after endovascular aortic arch repair are limited. In this study, including 255 TVs revascularized using branched arch devices, bridging was performed with covered stents, of which 90% were self-expanding. Relining was at the discretion of the operator and was 14% for the innominate, 35.2% for the left common carotid and 22.5% for the left subclavian artery branches. No 30-day occlusion was detected. The freedom from TV instability was almost 95% at 12 months. TV instability and reintervention were mainly attributed to endoleaks type Ic and IIIc.
Renal artery aneurysm (RAA) is a rare disease. This study proposed and evaluated a new classification for RAA to assist in surgical decision-making.
Single-center data of 105 patients with RAAs from the vascular department of vascular surgery were collected retrospectively. A new classification scheme was proposed. Type I aneurysms arise from the main trunk, accessory branch, or first-order branches away from any bifurcation. Type II aneurysms arise from the first bifurcation with narrow necks (defined as dome-to-neck ratio >2) or from intralobular branches. Type III aneurysms with a wide neck arise from the first bifurcation and affect 2 or more branches that cannot be sacrificed without significant infarction of the kidney.
There was 50 (47.62%) type I, 33 (31.43%) type II, and 22 (20.95%) type III aneurysms. The classification assigned endovascular repair as first-line treatment (for type I or II), while open techniques were conducted if anatomically suitable (for type III). A kappa level of 0.752 was achieved by the classification compared with a level of 0.579 from the classic Rundback classification. Technical primary success was achieved in 100% and 96.05%, and symptoms were completely resolved in 100% and 84.85%, while hypertension was relieved in 84.21% and 72.92% of patients receiving open surgery or endovascular repair, respectively. No significant difference was observed for perioperative or long-term complications among the 3 classification types.
The new classification proved to be a convenient and effective method for facilitating choice of intervention for RAAs.
This study proposed and evaluated a new classification scheme for renal artery aneurysms, which proved to be a convenient and effective method for facilitating surgical decision-making. Coil embolization was the first-line treatment if suitable, while aneurysm resection and reconstruction with vein graft were conducted for some complex lesions. The safety and efficacy of both open and endovascular methods were validated.
Surgical thromboendarterectomy has been the gold standard treatment for common femoral artery (CFA) disease. However, endovascular therapy (EVT) is conducted in certain patients with CFA lesions because of multiple comorbidities. The interwoven nitinol stent (IWS) has been developed to prevent stent fracture. Thus, this study aimed to evaluate the feasibility of EVT using IWS for CFA lesions in clinical practice.
This retrospective multicenter registry analyzed patients who had symptomatic lower-extremity artery disease due to CFA lesions and underwent EVT using IWS between 2019 and 2021. The primary endpoint was restenosis 2 years after EVT.
This study enrolled a total of 177 patients with 196 CFA lesions. The 2-year estimate of freedom from restenosis was 88.0%. The 2-year freedom rates from the target-lesion revascularization, major amputation, and all-cause death were 92.9%, 99.0%, and 75.2%, respectively. The clinical features significantly associated with restenosis risk were the reference vessel diameter (RVD, per 1.0 mm, hazard ratio [HR], 0.24 [0.08–0.70]; p=0.009), external iliac artery (EIA) involvement (HR=4.03 [1.56–10.4]; p=0.004), superficial femoral artery (SFA) involvement (HR=3.05 [1.00–9.25]; p=0.049), body mass index (BMI; per 1.0, HR=0.85 [0.73–0.99]; p=0.032), occlusion of deep femoral arteries (DFAs) at baseline (HR=7.89 [2.04–30.5]; p=0.003), and chronic limb-threatening ischemia (CLTI, HR=2.63 [1.02–6.78]; p=0.045). Their significant association was also confirmed by the random survival forest analysis. During a median follow-up of 12.0 months, guiding sheaths were inserted via CFAs implanted IWSs in 73 cases (37.2%), and no patients had cannulation-related complications, such as failed hemostasis, fracture of IWS, and stent occlusion.
Endovascular therapy using IWS in CFA lesions showed acceptable 2-year patency rates at 88.0% and might preserve the arterial access via the ipsilateral CFAs. Small RVD, involving EIA and SFA lesions, emaciation, occluded DFA, and CLTI are associated with poor 2-year patency rates following EVT, thus, IWS implantation in CFA lesions may be an option for patients unsuitable for surgical revascularization.
This retrospective multicenter registry enrolled 177 patients with 199 CFA lesions treated with EVT using interwoven nitinol stents, because surgical thromboendarterectomy was difficult due to their multiple comorbidities. The 2-year estimate of freedom from restenosis was acceptable at 88.0%. The 2-year freedom rate from major amputation was also high at 99.0%. Moreover, during a median follow-up of 12.0 months, guiding sheaths were inserted via CFAs implanted IWSs in 73 cases, and no patients had cannulation-related complications such as failed hemostasis, fracture of IWS, and stent occlusion.
The purpose of this study is to compare the initial outcomes of using the Chocolate balloon pre-dilatation (CLP) and sequential enlarging angioplasty pre-dilatation (sequential balloon pre-dilation [SP]) techniques versus the conventional balloon pre-dilatation (CP) method prior to drug-coated balloon (DCB) treatment for femoropopliteal (FP) lesions.
This was a retrospective analysis of prospectively collected data from the CIVILIAN (Clinical InVestigation of different lesIon preparation modaLIty followed by DCB in femoropopliteal Artery occlusioN disease) registry. Between March 2021 and November 2022, 3 pre-dilation techniques used prior to the DCB angioplasty were included. The study endpoint included intraoperative finial severe dissection after provisional stent placement, bailout stenting rate, the diameter of the largest pre-dilation balloon and DCB, as well as major adverse events (MAEs), including death, major limb amputation, or target vessel revascularization at 6 months.
During the study period, 435 limbs (429 patients) were pre-dilated before DCB treatment in FP lesions, 166 limbs were pre-dilated with Chocolate balloons, 93 limbs with sequential enlarging balloon pre-dilation technique, and 176 limbs with CP. The largest pre-dilation balloon was significantly larger in CLP and SP groups than that in the CP group (CLP 4.74±0.52 mm vs CP 4.36±0.64 mm, p<0.001; SP 4.82±0.69 mm vs CP 4.36±0.63 mm, p<0.001). A consistent result was shown in DCB diameter (CLP 4.86±0.44 mm vs CP 4.71±0.51 mm, p=0.003; SP 4.90±0.58 mm vs CP 4.71±0.51 mm, p=0.006). The bailout stenting rate was significantly lower in the CLP group than that in the CP group (18.1% vs 30.1%, p=0.011). The rates of MAEs at 6 months in the CLP and SP groups were comparable to those in the CP group (7.2% and 8.6% vs 6.3%, p>0.05). The risk for intraoperative bailout stenting rate was related to TASC D classification (3.59, 95% CI: 1.83–7.05, p<0.001), chronic total occlusion (CTO) lesion (1.82, 95% CI: 1.07–3.10, p=0.028), as well as pre-dilated with the conventional balloon (1.64, 95% CI: 1.00–2.69, p=0.048).
By utilizing chocolate balloon and sequential enlarging angioplasty, it becomes possible to use larger pre-dilation balloons and DCBs. In addition, the use of the chocolate balloon can significantly reduce the need for bailout stenting when compared with conventional balloons.
The utilization of a chocolate balloon and sequential enlarging angioplasty has emerged as a promising technique for angioplasty procedures. This approach allows for the use of larger pre-dilation balloons and drug-coated balloons. The use of the chocolate balloon can significantly reduce the need for bail-out stenting when compared to conventional balloons. Further research is required to determine the impact of vessel preparation techniques on the primary patency.
Outcomes of late open conversion with graft replacement for enlargement after endovascular aortic repair remain unclear. Here, we report the outcomes of graft replacement after endovascular aortic repair.
Fourteen patients who underwent graft replacement after endovascular aneurysm repair between November 2016 and October 2022 were included. Graft replacement was indicated in cases of rupture and enlargement of the aneurysm sac and when reintervention with endovascular therapy could not be performed.
The mean age at graft replacement was 80 ± 7 years. The follow-up period from endovascular aortic repair to graft replacement was 73 ± 41 months. The endoleaks that caused enlargement of the aneurysm sac were type I in 8 patients and type II in 6 patients. Ruptures were observed in 5 patients. One patient had paraplegia as a postoperative complication, and 2 patients died within 30 days. Morbidity and mortality were observed in cases of rupture, and no morbidity or mortality was observed in any elective surgery cases.
Late open conversion with graft replacement after endovascular aortic repair is a feasible elective surgery. However, morbidity and mortality have been observed in cases of rupture.
In elective surgery, postoperative outcomes are good for late open conversion with graft replacement after endovascular aortic repair. On the other hand, morbidity and mortality were observed in case of rupture. Therefore, it is important to perform elective surgical reintervention at the appropriate time.
The aim of this comparative study was to evaluate the increased aortic diameter of the distal aorta after implementing the STABILISE technique in complicated type B aortic dissection (AD).
This is a comparative monocentric retrospective study.
All patients who underwent an STABILISE procedure for complicated AD between 2018 and 2020 were included and compared with a historic cohort treated with thoracic endovascular aortic repair (TEVAR) alone. Aortic diameters were measured at 6 different levels on the thoracic and abdominal aorta. The primary end point was an increased aortic diameter at 1 and 2 years. The exclusion criterion was the absence of a computed tomography (CT) scan at 1 or 2 years.
A total of 55 patients were included: 24 in the TEVAR group and 31 in the STABILISE group. At the level of the stent graft, there was a decrease in aortic diameters in both groups without significant differences. At the level of the distal aorta, there was an increase in aortic diameters in both groups without significant differences. There were significantly more patients in the TEVAR group with an unfavorable increase in aortic diameter >5 mm of the distal aorta at 2 years than in the STABILISE group: 8 (33%) vs 1 (3%) (p=0.01). For chronic ADs, a significantly greater increase in aortic diameters of the distal aorta was observed in the STABILISE group.
The STABILISE technique is technically feasible and potentially leads to decreased longer re-intervention rates; indeed, more patients had an unfavorable increase in aortic diameter in the TEVAR group than in the STABILISE group at 2 years. The high rate of long-term distal aortic aneurysm progression and reintervention after TEVAR alone suggests that this option is not sufficient to definitively treat these complex patients.
This article reported the results of stent assisted balloon induced intimal disruption and relamination (STABILISE) with a follow-up at 2 years. This is the first comparative study between STABILISE, which has emerged as a new technique inducing aortic remodeling and therefore better long-term outcome, and the standard technique TEVAR alone. STABILISE technique is associated with good results on the distal aorta at 2 years with a rate of patient with unfavorable aortic diameter evolution greater in TEVAR group compared to STABILISE group and could improve the long-term results on the distal aorta by inducing extensive aortic remodeling.
The purpose of this study was to identify the independent predictors of higher patency rates and investigate the selection of specifications of stent graft in the treatment of central venous disease.
This retrospective study included 54 patients who underwent stent–grafts’ placement for the treatment of central venous disease between March 2017 and September 2022 at a tertiary hospital. The demographic data for the patients and the clinical data of the treated lesions were collected and analyzed. The patency rates of the treated lesions with different oversizing range were calculated via the Kaplan-Meier and log-rank analyses. The multivariate Cox proportional hazard models were constructed to identify the independent predictor of the target site primary patency.
The median follow-up period was 21.5 months. The primary patency rates of the target sites were 90.7%, 72.2%, and 55.1% at 6, 12, and 24 months, respectively. The assisted primary patency rates of the lesions were 96.3%, 92.5%, and 80.3% at 6, 12, and 24 months, respectively. The log-rank analysis showed that the stent–grafts’ placement with small oversizing had significantly higher primary patency rates than those with large oversizing (p=0.022). The multivariate analysis revealed that concomitant stenosis and large oversizing stent graft were the independent predictors of target site primary patency.
Stent grafts showed reasonable primary patency for the treatment of central venous disease in hemodialysis patients. A stent graft with small oversizing is associated with better target site primary patency rates than those with large oversizing.
Stent grafts showed reasonable primary patency for the treatment of central venous disease in hemodialysis patients. Few studies, however, have explored the efficiency of stent grafts to treat CVD by considering different factors such as sizing considerations, the rate of oversizing percentage, etc. A stent graft with small oversizing is associated with better target site primary patency rates than those with large oversizing. Excessive oversizing should be avoided to prevent infolding or stent collapse.
The potential benefit of transcarotid artery revascularization (TCAR) over transfemoral carotid artery stenting (tfCAS) has been studied in the perioperative period with lower rates of stroke and death; however, data on mid-term outcomes are limited. We aimed to evaluate 3-year outcomes after TCAR and tfCAS and determine the primary predictors of 30-day and 1-year mortality following TCAR.
Data from the Vascular Quality Initiative for patients undergoing TCAR or tfCAS from January 2016 to December 2022 were analyzed. 1:1 propensity score matching using the nearest-neighbor method was used to adjust baseline demographics and clinical characteristics. Kaplan-Meier survival analysis and Cox Proportional Hazard Regression were used to evaluate long-term outcomes. Iterative stepwise multiple logistic regression analysis and Cox Proportional Hazard Regression were used to identify predictors of 30-day and 1-year mortality, respectively, based upon preoperative, intraoperative, and postoperative factors.
A total of 70 237 patients were included in analysis (TCAR=58.7%, tfCAS=41.3%). Transcarotid artery revascularization patients were older and had higher rates of comorbid conditions and high-risk medical and anatomic features than tfCAS patients. Propensity score matching yielded 22 322 pairs with no major differences between groups except that TCAR patients were older (71.6 years vs 70.8 years). At 3 years, TCAR was associated with a 24% reduction in hazard of death compared with tfCAS (hazard ratio [HR]=0.76, 95% confidence interval [CI]=0.71-0.82, p<0.001), for both symptomatic and asymptomatic patients. This survival advantage was established in the first 6 months (HR=0.59, 95% CI=0.53-0.62, p<0.001), with no difference in mortality risk from 6 months to 36 months (HR=0.95, 95% CI=0.86-1.05, p=0.31). Transcarotid artery revascularization was also associated with decreased hazard for 3-year stroke (HR=0.81, 95% CI=0.66-0.99, p=0.04) and stroke or death (HR=0.81, 95% CI=0.76-0.87, p<0.001) compared with tfCAS. The top predictors for 30-day and 1-year mortality were postoperative complications. The primary independent predictor was the occurrence of postoperative stroke.
Transcarotid artery revascularization had a sustained mid-term survival advantage associated over tfCAS, with the benefit being established primarily within the first 6 months. Notably, our findings highlight the importance of postoperative stroke as the primary independent predictor for 30-day and 1-year mortal.
The ongoing debate over the superiority of TCAR compared to tfCAS and CEA has been limited by a lack of comparative studies examining the impact of pre-operative symptoms on outcomes. Furthermore, data are scarce on mid-term outcomes for TCAR beyond the perioperative period. As a result, it remains uncertain whether the initial benefits of stroke and death reduction observed with TCAR over tfCAS persist beyond one year. Our study addresses these gaps in the literature, offering evidence to enable clinicians to assess the efficacy of TCAR for up to three years. Additionally, our study seeks to identify risk factors for postoperative mortality following TCAR, facilitating optimal patient stratification
The aim of this study is to present single-center outcomes in patients treated with in situ laser fenestration thoracic endovascular aortic repair (LFTEVAR) for various aortic arch pathologies and assess the impact of increasing experience.
The STrengthening the Reporting of OBservational studies in Epidemiology (STROBE) statement was followed. A retrospective analysis of prospectively collected single aortic center data was conducted, including baseline information and peri- and post-operative outcomes of consecutive patients managed with LFTEVAR for aortic arch pathologies. Patients were enrolled from April 1, 2017 to January 31, 2023. The cohort was dichotomized to compare early (2017-2019) and late experience (2020-2023). Primary outcomes were peri-operative mortality and cerebrovascular morbidity.
Thirty patients were included (63.3% males, mean age 69.8±9.6 years); 21.4% presented with aortic ruptures. Aortic aneurysm involving the aortic arch was the most frequent pathology (53.3%). Forty target vessels (TVs) were revascularized, including 19 left subclavian arteries (47.5%) and 17 left common carotid arteries (42.5%). Double fenestrations were performed in 10 patients. The proximal landing zone was Ishimaru zone 0 in 5 patients (16.7%) and zone 1 in 13 patients (43.3%). Technical success was 93%. No spinal cord ischemia was recorded, and 3 patients (10%) suffered a post-operative stroke, of which 1 was major (3.3%). The median follow-up was 12 months (range=1-48 months). Thirty-day and follow-up mortality rates were 13.5% and 15.3%, respectively. Target vessel instability was 10%, of which 3.8% required reintervention. There was no statistically significant difference in outcomes between the early and late experience groups.
Laser fenestration thoracic endovascular aortic repair of the aortic arch performed in experienced aortic centers is associated with low early mortality and stroke rates. It is a safe and effective therapeutic option in patients considered unfit for open repair.
Custom-made devices for arch pathologies requiring urgent repair are not an option because of manufacturing delays. Off-the-shelf devices with single branch arch prostheses, and outside IFU techniques such as parallel-grafts and surgeon-modified endografts have been proposed in this setting. Another off-the-shelf alternative is in situ laser fenestration thoracic endovascular repair (LFTEVAR), which addresses many limitations of the other off-the-shelf options. Our study reports the outcomes of 30 patients treated with LFTEVAR, showing that it is a viable therapeutic option in patients considered unfit for open repair acknowledging that sufficient experience with complex endovascular aortic repair is mandatory to achieve acceptable outcomes in these high-risk patients with challenging aortic anatomies.
The aim of this study was to evaluate the midterm efficacy and safety of a single-branch Castor stent graft in the treatment of thoracic aortic disease.
Clinical data of 106 patients with thoracic aortic disease treated with Castor single-branch stent graft at 3 centers were collected between May 2018 and June 2023. The indicators included technical success, stent-related complication, reintervention, retrograde dissection, endoleak, distal stent graft–induced entry (dSINE), branch patency, and mortality. The outcomes of the Castor stent graft for multibranch reconstruction above the arch was also analyzed.
The technical success was 98.1% (104/106), while the surgical success was 93.4% (99/106). The reintervention was 2.8% (3/106), consisting of a case of retrograde type A dissection, an endoleak, and a dSINE. The retrograde dissection was 1.9% (2/106), while type I endoleak was 1.9% (2/106). The new dSINE was 2.8% (3/106), and the branch patency rate was 100%. The mortality was 1.9% (2/106). The mean follow-up time was 29.1±17.7 months. The 2-year post-surgery cumulative survival rate was 91.0%±3.1%, while the cumulative branch patency rate was 96.2%±2.2%. In addition, the cumulative freedom from stent-related reintervention rate was 93.2%±2.8%. A comparison showed no significant difference in the stent-related complication, branch patency, endoleak, reintervention, and mortality when the proximal end of the Castor stent graft was anchored to zones 1 or 2 of the aorta.
Castor single-branch stent graft showed favorable early and midterm outcomes in the treatment of thoracic aortic disease. In addition, it was feasible to combine Castor stent graft with other advanced techniques for multibranch aortic arch reconstruction.
The Castor single-branch stent graft was approval by the Chinese Food and Drug Administration in 2017. However, there were few studies on the mid-term outcomes for thoracic aortic disease after launching, which mainly focused on small single-center retrospective study. In the study, we assessed the mid-term outcomes of Castor stent graft through multi-center cases, Castor stent graft combined with other advanced techniques (such as fenestration and hybrid) for multi-branch reconstruction of aortic arch were also conducted. We found Castor single-branch stent graft showed favorable early and mid-term outcomes in the treatment of thoracic aortic disease. Additionally, it was feasible to combine Castor stent graft with other advanced technique for multi-branch aortic arch reconstruction. As an off-the-shelf branched stent graft with a wide range of models, it could be also used in most emergent situation. The Castor stent graft was expected to become more widely used in the future.
To analyze the incidence and predictive factors of postoperative acute kidney injury (AKI) after elective standard endovascular aortic repair (EVAR) in a large recent, multicenter cohort.
This is a multicenter, retrospective, financially unsupported physician-initiated observational cohort study. Between January 2018 and March 2021, only patients treated with elective standard EVAR for infrarenal non-infected abdominal aortic aneurysm were analyzed. Patients already on hemodialysis (HD) were excluded. AKI was defined as an increase in serum creatinine (sCr) ≥0.3 mg/dL within 48 hours or an increase in sCr to ≥1.5 times baseline known or presumed to have occurred within 7 days, or a urine volume of <0.5 mL/kg/h for 6 hours. Primary outcomes of interest were AKI incidence at 30 days and freedom from HD at 1-year follow-up. Secondary outcomes were freedom from severe postoperative complication, and freedom from aorta-related mortality (ARM) at 1 year.
The final cohort analyzed 526 (29.8%). There were 489 (93%) males and 37 (7%) females: the median age was 76 years (interquartile range [IQR], 71–81). Chronic kidney disease (CKD) was present in 86 (16.3%) patients. Early mortality was observed in 8 (1.5%) patients, none was aorta-related. Complication rate was 17.1% (n=89). AKI was observed in 17 (3.2%). Renal replacement therapy was needed in 4 (0.8%). HD was transitory in 2 cases and definitive in 1. Binary logistic regression analysis identified CKD (odds ratio [OR]: 4.68, 95% confidence interval [CI]: 2.10–10.45, p<0.001), and the presence of renal artery stenosis (OR: 3.80, 95% CI: 1.35–10.66, p=0.011) to be associated with an increased risk of postoperative AKI. Estimated freedom from ARM was 94.9% at 1 year. Estimated freedom from HD rate at 1 year was 94%: This was significantly different between patients with preoperative CKD and those who did not have preoperative CKD (log-rank, p=0.042).
AKI after elective standard EVAR still occurs but with an acceptably low incidence rate. Preoperative CKD is the most important predictor for postoperative AKI, which was not associated with the need for HD at 1-year follow-up but with a higher propensity of mortality.
This “real world” experience confirm that EVAR performed with standard contrats agent protocol remains safe for acute kidney injury development. Therefore, only patients presenting with preoperative borderline or ascertained chronic kidney disease will take the most advantage from the use of carbon dioxide contrast.
To analyze the early performance and efficacy of the first commercially available off-the-shelf precannulated multibranched endograft in the endovascular repair of pararenal abdominal aortic aneurysms (PAAAs). The device received European marketing approval in late 2020.
Between January 2021 and June 2023, a retrospective analysis of prospectively collected data from all consecutive patients with pAAAs undergoing implantation of the E-nside precannulated inner-branched endograft was conducted in 2 centers. The primary outcome measure was technical success defined as the composite endpoint of successful (1) delivery of the 24F endograft, (2) use of the precannulation tubes, and (3) implantation of the bridging stent-grafts (BSGs) to the target vessels. Main secondary endpoints were mortality, target vessel instability (TVI), absence of type I or III endoleak, reintervention, spinal cord ischemia, and supra-celiac aortic coverage.
Twenty-one patients (20 men, mean age: 71 years) were included in this study with a mean follow-up of 14±7.7 months. Nine patients had a symptomatic aneurysm (43%). Technical success amounted to 95% (in one patient, an iliofemoral conduit was necessary to advance the device). One out of 112 BSGs (1%, right renal artery) occluded at 30 days, resulting in freedom from TVI and reintervention rate at 12 months of 95%. No type I or III endoleaks were identified during follow-up. One patient (5%) died at 13 months due to non-aneurysm-related death, and 1 patient (5%) developed spinal cord ischemia. No other major perioperative complications were observed. Mean supra-celiac aortic coverage reached 52±8%.
Given the imperative need for an off-the-shelf endograft tailored to address PAAAs, the E-nside stent-graft demonstrated encouraging outcomes in this study. Nevertheless, it is essential to emphasize that the extent of aortic coverage mandates the production of a truncated variant.
The endovascular repair of urgent pararenal aortic aneurysms remains still an unsolved problem in the endovascular era since there are no available off-the-shelf dedicated fenestrated or branched endografts. This paper confirms the safety and efficacy of the off-the-shelf precannulated inner branched endograft for this specific indication.
The femoropopliteal arteries are commonly affected by atherosclerotic lesions. The use of atherectomy may increase the benefit of definitive therapy, such as drug-coated balloon (DCB) angioplasty.
To analyze the 2-year safety and efficacy of atherectomy in general and stratified by directional atherectomy (DA) and front-cutting atherectomy (FA) for the treatment of atherosclerotic lesions of the femoropopliteal arteries.
A retrospective analysis was performed including patients who underwent vessel preparation with atherectomy. The primary endpoint was the 2-year incidence of target lesion revascularization (TLR). Secondary endpoints included primary patency, changes in ankle-brachial index (ABI) and Rutherford-Becker class (RBC), and amputation rate up to 2 years.
Nine hundred and fifty-five patients (37.8% female; mean age: 69.7±9.6 years) were included in this analysis. Eight hundred and twenty-one patients (86%) were claudicants, 134 patients (14%) had critical limb-threatening ischemia. Six hundred and forty-four lesions (67.4%) were in a native artery and 145 lesions (15.2%) were in-stent restenoses. In 166 patients (17.4%), atherectomy was performed in native and in-stent segments. Eight hundred and thirty-seven patients were treated with DA and 118 patients with FA. Five-hundred and seventy-four procedures (60.1%) were followed by DCB angioplasty, provisional stent rate was 20% overall. One hundred and fifty-four procedure-related adverse events (16.1%) were documented, four complications (0.4%) required surgical intervention. At 2 years, 279 patients (34.3%) required TLR. After DA, TLR rates were 9%, 19.5%, and 32.2% at 6, 12, and 24 months, respectively, and 14.2%, 29.4%, and 49%, at 6, 12, and 24 months after FA. After DA, primary patency rates were 75.9%, 57.4%, and 40.3% at 6, 12, and 24 months, respectively, and 64.9%, 44.8%, and 26%, at 6, 12, and 24 months, respectively, after FA. Mean ABI and mean RBC improved significantly during follow-up (p<0.001), 17 patients required amputation, 13 minor (1.6%) and four major (0.5%). Regression analysis shows that more calcified lesions are more likely to have a TLR. Compared with a vessel diameter of 4 mm or smaller, larger diameters are associated with fewer TLRs.
In this retrospective analysis, atherectomy of femoropopliteal lesions shows satisfactory mid-term results.
German Clinical Trials Register: DRKS00031245
The results of this analysis could influence the daily practice of the interventionalists. A combination of atherectomy as vessel preparation followed by drug coated balloon angioplasty appears to be promising, but would need to be investigated in randomised trials.
Long-term safety and efficacy outcomes of Surpass Evolve flow diverter (SEFD) in treatment of intracranial aneurysms are lacking. Factors predicting complete aneurysm occlusion are elusive in literature.
A retrospective review of all consecutive aneurysms treated with SEFD from February 2020 to July 2022, at a single comprehensive stroke center.
Fifty-one patients with 80 aneurysms were included. Mean target aneurysm size was 5.6 mm and mean neck-width 3.42 mm. Small aneurysms (<10 mm) were 75% (n=60), while 25% were >10 mm. Unruptured were 71 (88.7%), previously ruptured were 8 (10%), and partially thrombosed 2.3% (n=1). Mean SEFDs used per patient were 1.07 and 40% (n=22) procedures were performed transradially. Mean procedure time was 59.1 minutes. The technical success rate for device deployment was 100%. Raymond Roy (RR) class I occlusion at 6 month (n=73) was seen among 56.2% (n=41), at 1 year (n=35) among 85.7% (n=30) and at 2 year (n=18) among 88.8% (n=16) aneurysms. Aneurysm size <10 mm significantly predicted RR-I occlusion outcome (odds ratio [OR]: 2.16; confidence interval [CI]: 0.02-4.29) at 6 months. Age, gender, smoking status, hypertension, location of aneurysm, and rupture status did not predict RR-I occlusion outcome. No mortality or permanent neurological morbidity was observed in the cohort. Major complications seen in 7.2% (n=4) patients were stent thrombosis (n=1, 1.8%), carotid-cavernous fistula (n=1, 1.8%) and transient ischemia in 2 (3.6%). Non-flow limiting stenosis was observed in 3 (5.4%) patients.
SEFD gives good aneurysm occlusion rates with favorable long-term safety profile and low rate of thromboembolic complications. Small aneurysm size (<10 mm) was associated with complete aneurysm occlusion at 6-month angiographic follow-up.
As Surpass Evolve is a newer generation Flow diverter of the Stryker Surpass FDs, with its improved design and applicability in intracranial aneurysms, we believe that more physicians will be encouraged to use this device worldwide.
This study aimed to evaluate the impact of the diverse stent size selection on the clinical and angiographic outcomes of Willis covered stent (WCS) for the treatment of skull base cerebrovascular diseases.
A total of 147 patients with 151 skull base cerebrovascular diseases treated with WCS in 3 centers between January 2015 and July 2022 were included in this study. Several parameters depicting stent size and parent artery condition were incorporated into the analysis of the outcomes.
Complete occlusion was found in 106 cases (68.2%) immediately after deployment and 126 cases (83.4%) after technical adjustment. In the multivariate logistics analysis, the difference between stent diameter and parent artery diameter (DD) was significantly associated with immediate endoleak without adjustment (odds ratio [OR]=0.410; p=0.005) and late endoleak (OR=0.275; p=0.028). In addition, differences between stent diameter and parent artery diameter at wide landing point (DSW) and differences between stent diameter and parent artery diameter at narrow landing point (DSN) was also was significant associated with immediate endoleak without adjustment and balloon re-dilation respectively.
This study demonstrated that the diameter selection of the WCS was associated with the occurrence of endoleak during the treatment of skull base cerebrovascular diseases. Precise selection and evaluation of stent size and vessel condition were significant factors for skull base cerebrovascular diseases treated by WCS.
This study demonstrates a significant association between the diameter selection of the Willis covered stent (WCS) and the occurrence of endoleak in the management of skull base cerebrovascular diseases. The results offer valuable medical evidence that can inform stent selection for WCS. The study emphasizes the significance of precise evaluation of stent size and vessel condition as crucial factors in WCS procedures. These findings underscore the importance of meticulous consideration and individualized approaches to stent selection, ultimately improving treatment outcomes in clinical practice.
To identify risk factors for in-stent restenosis (ISR) in patients undergoing stent placement for superior mesenteric artery dissection (SMAD) and to determine the hemodynamic mechanism underlying ISR.
For this retrospective study, patients with SMAD who had ISR after stent placement were included in the ISR group, and age- and sex-matched patients with SMAD who did not experience ISR after stent placement were included in the control group. Clinical, imaging, and hemodynamic data were assessed. Multivariable regression was used to identify independent ISR risk factors. Structural and fluid dynamics simulations were applied to determine the hemodynamic mechanism underlying the occurrence of ISR.
The study population included 26 patients with ISR and 26 control patients. Multivariate analysis demonstrated that stent-to-vascular (S/V) ratio (odds ratio [OR], 1.14; 95% confidence interval [CI]: 1.00–1.29; p=0.045), stent proximal position >10 mm away from the SMA root (OR, 108.67; 95% CI: 3.09–3816.42; p=0.010), and high oscillatory shear index (OSI) area (OR, 1.25; 95% CI: 1.02–1.52; p=0.029) were predictors of ISR. In structural and fluid dynamics simulations, a stent proximal position near the abdominal aorta (AA) or entering into the AA reduced the contact area between the proximal struts of the stent and the vascular wall, and alleviated the distal lumen overdilation.
The S/V ratio, stent proximal position away from the SMA root (>10 mm), and high OSI area are independent risk factors for ISR in patients with SMAD undergoing stent placement. Deploying the proximal end of the stent near the AA or entering into the AA appears to improve the hemodynamic environment in the SMA lumen and ultimately reduce the risk of ISR.
In-stent restenosis is an uncommon but potentially catastrophic complication after stent placement for the management of superior mesenteric artery dissection. This study identified risk factors for in-stent restenosis and demonstrated that, as long as the stent can fully cover the dissection range, deploying the proximal end of the stent near the abdominal aorta or less entering into the abdominal aorta may reduce the risk of in-stent restenosis in this patient population.
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.
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.
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.
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.
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.
Paclitaxel eluting balloons and stents reduce the development of intimal hyperplasia and restenosis rate after endovascular treatment for peripheral arterial disease (PAD) in the lower extremities. As diabetes mellitus (DM) worsens the prognosis in PAD patients after invasive endovascular treatment, we assessed the effects of drug eluting technology for PAD with special focus on effects in patients with and without DM. All Swedish patients registered in the Swedish vascular registry Swedvasc after vascular or endovascular surgery for intermittent claudication, IC; (n=1948) or chronic limb threatening ischemia, CLTI (n=3353) in 2013 to 2015 were followed up regarding a composite of either major amputation and/or mortality during median 607 days and for reinterventions for PAD during median 522 days. Patients with DM registered in the Swedish National Diabetes Registry (NDR) and patients without DM were evaluated separately. The 201 CLTI patients with DM treated with drug eluting methods had a lower adjusted risk for amputation or mortality after adjustment than the 1476 CLTI patients with DM treated without drug eluting methods (hazard ratio [HR] 0.712 [0.562-0.901],
This retrospective observational registry trial combines national registries for vascular surgical procedures and diabetes mellitus to clarify results of drug eluting technology in treating diabetic subjects with intermittent claudication or chronic limb threatening ischemia compared to treatment of non-diabetic subjects. As earlier proposed and showed in this trial, there may be an implication for a beneficial treatment efficacy with drug eluting therapy in the diabetic population with PAD compared to the non-diabetic population. A finding worth further exploration.
Penetrating aortic ulcer (PAU) is a rare etiology of acute aortic syndrome. Few studies exist regarding the perioperative outcome. The aim was to analyze clinical outcome and risk factors of mortality in this treatment population.
Retrospective, monocentric study from 2010 to 2021. Clinical data of endovascular or open treated PAU were analyzed. In-hospital mortality was selected as the primary study endpoint. Angio-morphologies were analyzed and risk factors for mortality were identified by using univariate analysis.
Overall, 133 patients were identified. 29% (n=38) of patients presented symptomatically. In 64% (n=85), the PAU was localized in the thoracic aorta. On average, PAUs had a depth of 15.4±10.1 mm and a width of 17.9±9.6 mm. The patients had a median of 2 (95% confidence interval [CI]=2-3) high-risk features (HRF) as PAU depth >10 mm, PAU width >20 mm, aortic diameter >40 mm, symptomatic, intramural hematoma (IMH), pleural effusion. Significantly more HRF were observed in symptomatic patients (p=0.01). 53% (n=71) of patients were treated with thoracic endovascular aortic repair (TEVAR), 41% (n=54) by endovascular aortic repair (EVAR), and 6% (n=8) by open surgery. A hybrid procedure with cervical debranching was performed in 16% (n=21) and complex endovascular repair with fenestrated or branched endografts in 15% (n=20). Overall, complications greater than grade II according to the Clavien-Dindo classification occurred in 19% (n=25) and of the patients. In-hospital mortality manifested in 6% (n=8). Factors associated with increased mortality were the diameter of the aorta >40 mm (88% vs 39%, p=0.03), as well as symptomatic patients (63% vs 26%, p=0.04), coincident IMHs (38% vs 10%, p=0.05), and complex endovascular procedures (50% vs 50% p<0.01). Penetrating aortic ulcer width >20 mm tended to show higher mortality (75% vs 40%, p=0.06). Routine follow-up was available for 89% (n=117) for a median of 39 months (95% CI=25-42). One-year and 5-year survival were 83% and 60%, respectively, with 1 aortic pathology-related death.
Treatment of PAU is associated with an acceptable perioperative morbidity and mortality. Risk factors associated with increased mortality are an elevated aortic diameter, the presence of IMHs, clinical symptomatology at presentation, and complex endovascular procedures.
The purpose was to analyze the technical, clinical, and survival outcomes of our patients with malignant superior cava vein syndrome (SVCS) treated with endovascular approach and analyze the efficacy of different stent types used.
It is an observational, retrospective, single-center study. From 2006 to 2023, 42 patients (32 male, 10 female, mean age 62 years, age range, 41-87 years) underwent percutaneous stent placement for malignant SVCS. One stainless steel stent (Wallstent) and 2 venous nitinol stent type (Sinus-XL, Venovo) were used. Follow-up mean was 276 days.
A total of 53 stents were deployed. Clinical success was 97.6% in less 24 hours. Technical success was achieved in 97.6%. No complications were found except 1 patient died during the procedure due to stent migration and atrial dissociation (2.3%). Overall intraprocedural stent migration rate was 11.9% (18.8% stainless steel stent, 9.6% nitinol stent, p>0.05). Overall survival rates were 87.8%, 41.99%, and 34.12%, and overall primary patency rates were 100%, 93.3%, 91.6% at 1, 6, and 12 months, respectively.
Endovascular treatment is a safe and effective therapeutic option for SVCS with high technical and clinical success rates and low complication and recurrence rates.
The malignant superior cava vein syndrome is a rare clinical entity treated classically with radiation and chemotherapy with a slower response, or surgical bypass, which is an aggressive surgical technique. Endovascular treatment offers a low-invasive technique with quick clinical resolution and good permeability results. However, further studies are lacking to deal with procedure technical characteristics, stent type used, technical complications, and medium- and long-term patency studies. This study aims to evaluate all these items, analysing self-expanding stainless steel and nitinol venous bare metal stents, and add value to endovascular treatment, confirming the good results of this technique.
To identify potential hemodynamic predictors for limb thrombosis (LT) following endovascular aneurysm repair with the Anaconda endograft in a patient-specific phantom.
A thin-walled flow phantom, based on a patient’s aortic anatomy and treated with an Anaconda endograft, that presented with a left-sided LT was fabricated. Contrast-enhanced ultrasound particle image velocimetry was performed to quantify time-resolved velocity fields. Measurements were performed in the same phantom with and without the Anaconda endograft, to investigate the impact of the endograft on the local flow fields. Hemodynamic parameters, namely vector complexity (VC) and residence time (RT), were calculated for both iliac arteries.
In both limbs, the vector fields were mostly unidirectional during the peak systolic and end-systolic velocity phases before and after endograft placement. Local vortical structures and complex flow fields were observed at the diastolic and transitional flow phases. The average VC was higher (0.11) in the phantom with endograft, compared to the phantom without endograft (0.05). Notably, in both left and right iliac arteries, the anterior wall regions corresponded to a 2- and 4-fold increase in VC in the phantom with endograft, respectively. RT simulations showed values of 1.3 to 6 seconds in the phantom without endograft. A higher RT (up to 25 seconds) was observed in the phantom with endograft, in which the left iliac artery, with LT in follow-up, showed 2 fluid stasis regions.
This in vitro study shows that unfavorable hemodynamics were present mostly in the limb that thrombosed during follow-up, with the highest VC and longest RT. These parameters might be valuable in predicting the occurrence of LT in the future.
This in-vitro study aimed to identify potential hemodynamic predictors for limb thrombosis following EVAR using ultrasound particle image velocimetry (echoPIV) technique. It was shown that unfavorable hemodynamic norms were present mostly in the thrombosed limb. Owing to the in-vivo feasibility of the echoPIV, future efforts should focus on the evaluation of these hemodynamic norms in clinical trials. Thereafter, using echoPIV as a bedside technique in hospitals becomes more promising. Performing echoPIV in pre-op phase may provide valuable insights for surgeons to enhance treatment planning. EchoPIV is also applicable for follow-up sessions to evaluate treatment progress and avoid/predict complications.
The aim of this study was to evaluate the radiation dose, image quality, and the potential of virtual monoenergetic imaging (VMI) reconstructions of high-pitch computed tomography angiography (CTA) of the thoracoabdominal aorta on a dual-source photon-counting detector–CT (PCD-CT) in comparison with an energy-integrating detector–CT (EID-CT), with a special focus on low-contrast attenuation.
Consecutive patients being referred for an electrocardiogram (ECG)-gated, high-pitch CTA of the thoracoabdominal aorta prior to transcatheter aortic valve replacement (TAVR), and examined on the PCD-CT, were included in this prospective single-center study. For comparison, a retrospective patient group with ECG-gated, high-pitch CTA examinations of the thoracoabdominal aorta on EID-CT with a comparable scan protocol was matched for gender, body mass index, height, and age. Virtual monoenergetic imaging reconstructions from 40 to 120 keV were performed. Enhancement and noise were measured in 7 vascular segments and the surrounding air as mean and standard deviation of CT values. The radiation dose was noted and signal-to-noise ratio (SNR) and contrast-to-noise ratio (CNR) were calculated. Finally, a subgroup analysis was performed, comparing VMI reconstructions from 40 keV to 70 keV in patients with at least a 50% decrease in contrast attenuation between the ascending aorta and femoral arteries.
Fifty patients (mean age 77.0±14.5 years; 31 women) were included. The radiation dose was significantly lower on the PCD-CT (4.2±1.4 vs. 7.2±2.2 mGy; p<0.001). With increasing keV, vascular noise, SNR, and CNR decreased. Intravascular attenuation was significantly higher on VMI at levels from 40 to 65, compared with levels of 120 keV (p<0.01 and p<0.005, respectively). On the PCD-CT, SNR was significantly higher in keV levels 40 and 70 (all p<0.001), and CNR was higher at keV levels 40 and 45 (each p<0.001), compared with scans on the EID-CT. At VMI ≤60 keV, image noise was also significantly higher than that in the control group. The subgroup analysis showed a drastically improved diagnostic performance of the low-keV images in patients with low-contrast attenuation.
The ECG-gated CTA of the thoracoabdominal aorta in high-pitch mode on PCD-CT have significantly lower radiation dose and higher objective image quality than EID-CT. In addition, low-keV VMI can salvage suboptimal contrast studies, further reducing radiation dose by eliminating the need for repeat scans.
ECG-gated CT-angiographies of the thoracoabdominal aorta can be acquired with a lower radtiation dose and a better image quality by using a dual-source photon-countinge detector CT. Furthermore, the inherent spectral data offers the possiblity to improve undiagnostic images and thus saves the patient from further radiation and contrast application.
Acute deep vein thrombosis (DVT) is a potentially life-threatening condition in which blood clots form in the venous system. Recently, a number of endovascular thrombectomy devices have been introduced to treat acute DVT. Given their varied efficacy and safety profiles, a clear need exists for further device innovation and enhancement. However, a major limitation in the testing, verification, and validation of new thrombectomy devices is a clinically representative large animal model of acute DVT. Unfortunately, existing approaches to creating DVT in porcine models are time-consuming, technically challenging, and yield inconsistent results. We therefore developed a rapid, technically straightforward, and reproducible protocol for induction of large-volume iliocaval DVTs in a living porcine host. This approach involves sequestering the iliocaval venous segment with standard balloon occlusion catheters, and a controlled limited infusion of a 25% ethanol solution within the sequestered static segment. We observed that this method was safe, technically straightforward, and reproducible in producing large-volume acute DVTs. We believe that this technique can be utilized as a standardized DVT model in the testing of future endovascular venous thrombectomy devices.
The study establishes a rapid, technically straightforward, and reproducible porcine large animal model for acute iliocaval deep vein thrombosis (DVT). The procedure can be performed with basic endovascular skillsets. With its procedural efficiency and consistency, the platform is promising for comparative in vivo testing of venous thrombectomy devices in a living host, and for future verification and validation studies to determine efficacy of novel thrombectomy devices relative to predicates.
In approximate 40% of thoracic endovascular aortic repair (TEVAR) procedures, the left subclavian artery (LSA) needs to be covered to obtain sufficient proximal sealing zone. To preserve the LSA during the TEVAR for type B aortic dissection (TBAD) adjacent to LSA, our team designed a modular single inner-branched stent graft. This study was performed to evaluate the safety and feasibility of deploying a modular single inner-branched stent graft in a porcine model.
Modular inner-branched stent grafts were implanted in 14 pigs via right femoral and right carotid arterial access. Computed tomography angiography (CTA) and angiography were performed in all pigs to appraise the morphological characteristics of the stent grafts at the end of follow-up. The pigs were then euthanized, and tissues were collected for gross and histological examination.
The technical success rate was 100% (14/14). One pig suddenly died 5 hours after operation, and 1 pig died after completing the follow-up CTA. During the follow-up period, all surviving pigs showed good mental state, normal diets and activities. Computed tomography angiography examinations showed that all stent grafts were intact without fracture. All bridging covered stents were patent. Angiography showed that the position, shape, and adhesion of the stent grafts were good, and no obvious endoleaks were found. Histological examination showed that the biocompatibility of the stent grafts was good.
This study’s outcomes demonstrate that it is safe and feasible to deploy a modular single inner-branched stent graft in a porcine model.
This device is the first modular device designed to treat TBAD adjacent to LSA in China. This device is a modular two-component system consisting of a thoracic aortic stent graft with a retrograde inner branch and a bridging covered stent. The modular design and the retrograde inner branch are the two important innovations of this device. Theoretically, the device could make it easier and safer for clinicians to treat TBAD adjacent to the LSA.
A 33-year-old man with previously diagnosed lupus membranous nephropathy presented with painful swelling in both legs. Laboratory tests revealed acute kidney injury, and imaging studies by duplex ultrasound and computed tomography scan showed acute thrombosis of both renal veins, the infrahepatic inferior vena cava, and both iliofemoral venous segments. Initially, pharmacomechanical thrombolysis led to an insufficient morphological result. The therapeutic breakthrough was achieved by catheter-based mechanical thrombectomy of the infrarenal vena cava and both renal veins, which successfully cleared all affected venous segments from thrombus, paralleled by improvement of the patient’s condition. However, after 1 week, the patient experienced recurrent thrombosis of the right renal vein with hemorrhagic infarction of the right kidney. After further optimization of immunomodulatory and antithrombotic therapy, a repeated catheter-based mechanical thrombectomy resulted in sustained clinical improvement and preservation of renal venous drainage and kidney function.
Extensive acute thrombosis of both renal veins, the inferior vena cava, and both iliofemoral venous segments is a rare emergency potentially threatening kidney function. Immediate effective thrombus removal is essential to preserve kidney function and can be achieved by catheter-based mechanical thrombectomy embedded in a comprehensive immunomodulatory and antithrombotic therapeutic concept.
This case demonstrated the efficacy of a catheter-based therapeutic approach in patients with extensive thrombosis of the venous system. A catheter-based approach must be embedded in a comprehensive medical therapeutic concept, which is essential to achieve a sustainable result.
Blunt traumatic aortic injury (BTAI) is a rare occurrence in adolescents, yet it is associated with a high mortality rate necessitating immediate treatment. Although endovascular repair has become the preferred treatment for such injuries in adults, its effectiveness in adolescents remains uncertain.
Blunt traumatic aortic injury typically presents with concomitant injuries to other organs and carries a high perioperative mortality rate with operative repair (OR). In this report, we describe the treatment of 3 clinical cases of BTAI in adolescents using thoracic endovascular aortic repair (TEVAR). These cases contribute pertinent evidence supporting the efficacy of intravascular repair for BTAI.
Operative repair (OR) remains the gold standard for treating BTAI in adolescents. Nevertheless, TEVAR therapy presents a viable alternative for patients with multiple injuries in whom anticoagulation is contraindicated. Further long-term observation is necessary to assess the lasting effects of TEVAR therapy.
This study has provided insights into endovascular repair for adolescent BTAT, offering clinicians significant reference material for choosing treatment strategies for adolescent BTAT. The study aims to demonstrate the safety and effectiveness of endovascular repair treatments in a series of clinical cases involving adolescent BTAI.