Journal of Endovascular Therapy最新文献

Objective: There is great variability in the treatment of chronic limb-threatening ischemia, including the practice paradigm, vascular provider specialty, devices utilized, and experience with advanced open and/or endovascular treatments, among other factors. Our unique practice consists of patient-centered, clinically oriented Interventional Radiologists and Vascular Surgeons, with treatments being performed in Office Interventional Suites (OIS), Ambulatory surgery center (ASC), and hospital inpatient/outpatient settings. We evaluate our results, centered on major amputation rates while comparing case complexity and rates with previously published data.

Methods: A retrospective review was performed of all Rutherford 4, 5, and 6 patients who underwent treatment in our practice from 2015 to 2021. Baseline patient characteristics, complexity of lesions, and major amputation rates were collected. Patients with more complex diseases or requiring re-interventions were openly discussed in multidisciplinary fashion to determine the group's approach to revascularization. Limb salvage, clinically driven target lesion revascularization (TLR), repeat interventions, length of follow-up, and mortality were assessed.

Results: Treatment was performed in 829 limbs in 351 females and 478 males, with chronic limb-threatening ischemia. Of the 829 cases, 541 cases had at least 1 chronic total occlusion (CTO), including 115 limbs with 2 CTOs and 24 limbs with 3 CTOs with 63.5% of cases requiring multilevel intervention. One year mortality rate was 6.2% with a major lower extremity amputation rate of 2.3% with a mean length of follow-up of 22.3 months. One-year freedom from clinically driven TLR rate was 78.7% with repeat intervention in 163 cases within 12 months. Over the course of the study, within the femoropopliteal stent subset, there was a significant increase in time to reintervention when newer stent technologies were utilized such as woven nitinol and drug-eluting technology (p=0.03). The overall 1-year amputation-free survival (AFS) was 91.5.

Conclusions: Multidisciplinary approach with surgical and endovascular treatment may provide patients with the best chance of AFS.

Clinical impact: Real world practice of critical limb-threatening ischemia in a multidisciplinary practice demonstrates favorable outcomes for patients with the best reported one year major amputation free survival in a population this large. A strong clinical practice based on close routine follow up and arterial duplex monitoring is a major contributing factor, as well as utilization of the latest technology in drug eluting stents and drug coated balloons for best patient outcomes. We hope this study provides other practices with a guideline for establishing or modifying their practice to attain the best procedural and clinical outcomes.

Purpose: This technical note presents a case of a patient with a failed Nellix device (Endologix, Irvine, Calif) who was not deemed fit for open conversion. Our planned approach for repair involved an endovascular procedure utilizing a custom-made branched device.

Technique: An endovascular repair was performed via a custom-made four outer branched device in conjunction with a custom-made bifurcated graft featuring inverted limbs (Cook Inc., Bloomington, Ind). All branches were connected to the target vessel with Gore Viabahn VBX balloon-expandable covered stents (Gore & Associates Inc.).

Conclusion: Endovascular conversion with branched endovascular repair in a patient not deemed fit for open surgery was successfully performed, thereby reducing the risk of a high morbid and mortal procedure.

Clinical impact: Novel useful treatment solution of failed EVAR with Nellix device.

Purpose: Endovascular aortic repair (EVAR) is currently expanding its feasibility thanks to design innovations, but hostile proximal necks and narrow iliac arteries are still a constraint, as expressed by the Instructions for Use (IFU) of most devices. Our aim is to report the preliminary results of the E-Tegra endograft in infrarenal abdominal aortic aneurysms (AAAs) performed in 15 high-volume centers.

Materials and methods: The e-Tegra Italian endoGraft REgistry (TIGRE) is a prospectively maintained database of consecutive EVAR with the E-Tegra stent-graft across 15 participating centers between March 2021 and March 2023. The registry records baseline clinical data, anatomic measurements of the abdominal aorta, perioperative and postoperative outcomes, with a scheduled follow-up period of 3 years for all patients. This is a preliminary analysis of the first results updated to January 2024. The primary endpoints are technical and clinical success, perioperative mortality, freedom from endograft rupture, and aortic-related mortality. The secondary endpoints are freedom from reintervention, and any type of endoleak (EL). The results were analyzed in relation with the anatomic characteristics of the AAAs, namely, iliac axes tortuosity and proximal neck hostility.

Results: The registry included 147 consecutive EVAR (138 elective and 9 in emergent setting), 7 of which were associated with an iliac branch implantation. Ninety patients had at least 1 criterion of anatomical hostility, and 25 were treated outside the device IFU. Primary technical success was achieved in 146 cases (99.3%) and assisted success in 147 (100%), with no perioperative mortality. After a median follow-up period of 20 months, no aneurysm-related mortality occurred. Reinterventions were 5: 2 for type IB EL and 3 for type II ELs with aneurysm sac increase. Five more type II ELs with aneurysm sac stability are under observation. No differences in terms of reinterventions were noted between aneurysms with standard and hostile anatomy.

Conclusion: The E-Tegra endograft is safe and effective in treating AAAs with standard and hostile anatomy, with a low rate of complications and reinterventions, although longer-term outcomes and larger numbers are needed to compare its performances related to specific anatomic criteria.

Clinical impact: This multi-center nationwide Registry reports a real-world experience of EVAR performed with the E-Tegra abdominal endograft across 15 high-volume Centers, providing early- and mid-term device-specific results, which will help vascular surgeons in endograft selection. In particular, this study focuses on clinical results obtained in treating aneurysms with hostile anatomy, analyzing the performances of the E-Tegra endograft in cases of hostile proximal necks and narrow or tortuous iliac axes.

Objective: To understand possible reasons for poor durability of the Nellix (Endologix Inc., Irvine, USA) endovascular aneurysm sealing (EVAS) device.

Materials and methods: 21 Nellix endoprostheses explanted for endoleaks and migration underwent visual examinations of stent structures and instrumental examinations of the polymer endobags on 4 devices. We harvested 2.0-gram polymer slices out of each of them and tested the samples in an in vitro implantation replication that included wet and dry exposures. During the wet phase, we placed samples in a beaker with saline, mimicking the filling of the endobags during implantation. An exposure to a 37°C environment with 60% humidity during the dry phase replicated the postimplantation conditions inside the aneurysmal sac.

Results: Iatrogenic defects affected 16 (76%) metal stents and 20 (95%) endobags. The polymer was disintegrated owing to degradation in 15 (71%) cases. The polymer could lose more than 70% of its initial weight when partially dehydrated and regain 80% when placed in saline. We observed volume decrease and polymer fragmentation during these study phases.

Conclusions: The polymer can lose weight and volume while it dehydrates. This structural degradation of the polymer could lead to the development of endoleaks and/or migration of the device.

Clinical impact: Based on the results of previous investigations, due to possible endovascular device degradation, patients with endografts should be offered life-long surveillance, and the Nellix device is no exception. Herein we suggest polymer degradation as one of the possible reasons for the device failure. Although Nellix has been withdrawn from the market, there are numerous patients with this type of endograft. Due to its unpredictable performance in the medium and long term, these patients should be recommended enhanced life-long surveillance every 6 months. Any suspicious conditions during the follow-up must be taken seriously and explantation should be considered.

Purpose: Thoracic endovascular aortic repair (TEVAR) is a treatment for traumatic blunt thoracic aortic injury (BTAI) with good survival rates and safety. However, there is limited study on the risk factors for in-hospital mortality and complications. This study aimed to identify risk factors associated with poor in-hospital outcomes after TEVAR.

Materials and methods: This is a population-based, retrospective observational study. Data of adults ≥20 years admitted for BTAI who received TEVAR were extracted from the Nationwide Inpatient Sample (NIS) database 2005 to 2018. The primary outcome was in-hospital mortality, and the secondary outcomes were length of stay (LOS) and unfavorable discharge (ie, non-routine discharge, including nursing homes or long-term care facilities). Associations between study variables and in-hospital outcomes were determined using univariate and multivariable logistic and linear regression analyses.

Results: Data of 1095 participants (representing 5360 hospitalized patients in the United States) were analyzed. Multivariable analysis revealed that older age (adjusted odds ratio [aOR]=1.02) and having at least 1 perioperative complication (aOR=4.01) were significantly associated with increased risk for in-hospital mortality. Patients with at least 1 perioperative complication (aOR=11.19) had significantly increased odds for prolonged LOS. Risk for unfavorable discharge was significantly increased by older age (aOR=1.02), household income at quartile 2 (aOR=1.58), Charlson Comorbidity Index (CCI) 2 to 3 (aOR=1.66), and having at least 1 complication (aOR=3.94). Complications including perioperative cerebrovascular accident (CVA) (aOR=2.75), venous thromboembolism (VTE) (aOR=2.87), pneumonia (aOR=3.93), sepsis (aOR=4.69), infection (aOR=4.49), respiratory failure (aOR=4.55), mechanical ventilation (aOR=3.27), and acute kidney injury (AKI) (aOR=3.09) significantly predicted prolonged LOS.

Conclusions: In adults with traumatic BTAI undergoing TEVAR, advanced age and perioperative complications are risk factors for poor in-hospital outcomes. Acute kidney injury, CVA, respiratory failure, and sepsis are strong predictors of prolonged LOS, unfavorable discharge, and in-hospital mortality.

Clinical impact: The study identifies advanced age and perioperative complications as key risk factors for poor in-hospital outcomes in patients undergoing TEVAR for BTAI. Clinicians should be vigilant in managing these patients, particularly those with comorbidities, to mitigate risks. The findings suggest a need for tailored perioperative care strategies to improve survival rates and reduce complications. This research highlights the critical importance of early identification and intervention in high-risk patients, offering an innovative approach to refining TEVAR protocols and enhancing patient outcomes in trauma care.

Objective: The main objective of this paper is to analyze the outcomes regarding endoleaks, reinterventions, and death related to aneurysm complications in patients submitted to endovascular repair (EVAR) for abdominal aortoiliac aneurysm (AAA) using Endurant II (Medtronic) and Zenith Flex (Cook) endografts.

Methods: This was a prospective, consecutive cohort study of patients with AAA who underwent EVAR between January 2019 and December 2022. Two groups of patients were evaluated: Group Endurant (patients submitted to EVAR with the use of Endurant II) and Group Zenith (patients submitted to EVAR with the use of Zenith Flex).

Results: A total of 156 patients were evaluated. Group Zenith (67 patients, 42.9%) and Group Endurant (89 patients, 57.1%). The perioperative mortality was 5.1%, eight patients (six patients Group Zenith, and two patients Group Endurant, p=0.054). There were 28 patients (17.9%) submitted to urgent repair of the aneurysm (expansion or rupture), with no differences among the groups. There were 36 cases (23.1%) of later endoleak, with a higher incidence in Zenith group (23 patients, 34.3%) than Endurant group (13 patients, 14.6%, p=0.002), most of them Type II endoleak (21 patients, 13.4%). There were 12 cases of Type I endoleak, also with a higher prevalence in Zenith group (13.4%) than Endurant group (3.4%, p=0.002). Moreover, regarding limb graft occlusion (LGO), there were nine patients (5.8%), with a higher prevalence in Zenith group (9%) than Endurant group (3.4%, p=0.045). The overall survival in a Kaplan-Meier at 720 days was 82.3% in the Zenith group and 89.1% in the Endurant group, with no statistical significance among the groups (p=0.09). The freedom from reintervention rates in a Kaplan-Meier at 720 days was 82.8% in the Zenith group and 93.2% in the Endurant group (p=0.001).

Conclusion: In this present study, Zenith endograft had higher rates of endoleaks, aneurysms related mortality, LGO and reinterventions than patients submitted to Endurant II endografts. The linear regression analysis showed that the presence of endoleaks, type of endograft device (Zenith graft) and limb graft occlusion were related to higher reintervention rates.

Clinical impact: In this present study, Zenith endograft had higher rates of endoleaks, aneurysms related mortality, limb graft occlusions and reinterventions than patients submitted to Endurant II endografts. The main impact and the innovation that this article provides is an opportunity to evaluate and choose the best endograft suitable for the patient with AAA during EVAR.

Background: Previous reports have shown comparable outcomes between drug-eluting stents (DESs) and drug-coated balloons (DCBs) for treating femoropopliteal artery (FPA) lesions; however, DCB outcomes include approximately 10% to 50% bailout stents. Therefore, comparing DESs and DCBs is not simple. The aim of this study was to compare the clinical outcomes of DESs and DCBs in patients with symptomatic FPA disease.

Materials and methods: Using the registries of 7 institutions, we retrospectively reviewed the records of 1356 patients who underwent endovascular therapy for FPA with DESs (n=333; Eluvia, 74.0%; Zilver PTX stent, 26.0%) or DCBs without bailout stents (n=1023; IN.PACT, 67.6%; Lutonix, 32.4%). The primary outcome was the 1-year primary patency comparison between DESs and DCBs, using propensity score matching. The severity of the dissection pattern after predilatation (none or grades A-C) was included as an explanatory variable for matching. Patients with grade D dissections were excluded from the main analysis and assessed independently.

Results: After matching, the 1-year primary patency between DESs and DCBs was similar (88.8% vs 85.2%, p=0.31). By contrast, perioperative complications were frequent with DES, compared with DCB (5.1% vs 2.2%, p=0.005), and the intravascular ultrasound-evaluated minimum luminal area was significantly larger with DES than with DCB (19 mm² vs 14 mm², p<0.001). In the supplemental analysis of lesions with grade D dissection, the 1-year primary patency was significantly higher with DES than with DCB (86.1% vs 55.1%, p=0.014).

Conclusion: In FPA lesions without severe dissection (ie, no dissection or grade A-C dissection), DESs and DCBs showed comparable 1-year primary patency in matched populations. However, DCBs did not perform well with severe dissection (ie, grade D or more).

Clinical impact: The results of this study clearly define the appropriate boundaries for the "leaving nothing behind" strategy. Clinicians can now more clearly differentiate between the use of DES and DCB, based on the results of lesion preparation. Further prospective investigations with well-designed trials and larger populations are necessary to confirm these findings.

Purpose: The purpose of the study is to develop a prediction model for major amputation (MA) within 30 days after arterial revascularization in patients with acute lower limb ischemia (ALLI) using 2-dimensional (2D) perfusion imaging parameters.

Materials and methods: A retrospective study was performed in ALLI patients undergoing arterial revascularization between October 2015 and May 2022. Patients were randomly assigned into training and validation cohorts in a ratio of 7:3. Variables were selected using univariate and multivariate logistic regression. A nomogram for the MA risk within 30 days after arterial revascularization in ALLI patients was created. Its discrimination, calibration, and clinical effectiveness were reported.

Results: A total of 310 ALLI patients (326 limbs) were included. The MA rate within 30 days after arterial revascularization was 11.6%. Skin speckle, myoglobin, and time-to-peak were independent risk factors, while atrial fibrillation was a protective factor (all p<0.05). The nomogram predicted 30-day MA with satisfactory discriminative ability. The integrated discrimination improvement was 0.279 and 0.379 for the training and validation cohorts, respectively (both p<0.001). Calibration curves were close to the standard curve. The decision curve analysis demonstrated net benefits.

Conclusion: This 2D perfusion imaging parameter-based nomogram could accurately predict the risk of MA within 30 days postrevascularization in ALLI patients.

Clinical impact: This study introduces a novel nomogram based on 2-dimensional (2D) perfusion imaging that can significantly advance the prognosis prediction in ALLI patients. By calculating the risk of major amputation within 30 days postrevascularization, this nomogram offers an accurate predictive tool and can lead to more informed decision-making on patient management. The innovative aspect of this research lies in its utilization of 2D perfusion parameters, a novel approach that enhances risk assessment accuracy in ALLI patients. This nomogram represents a significant step toward risk stratification and can guide future research for appropriate management on ALLI patients with different risk profiles.

Purpose: To report the use of modified ex vivo renal artery (RA) reconstruction in a patient with 2 small right RAs (RRAs) in anticipation of planned fenestrated-branched endovascular aortic repair (FB-EVAR) of thoracoabdominal aortic aneurysm (TAAA).

Case report: A staged hybrid repair was utilized in a patient with Extent II TAAA involving celiac axis (CA), superior mesenteric artery (SMA), single left RA (LRA), and 2 small (<3 mm) RRAs. The first-stage operation consisted of hepato-renal bypass using modified ex vivo renal reconstruction with single end-to-end anastomosis to both RAs using a saphenous vein graft. A second stage FB-EVAR was performed using patient-specific manufactured stent-graft with 3 fenestrations for the CA, SMA, and LRA 6 weeks later. The patient recovered with no complications. At 4 years, the patient had widely patent hepato-renal bypass and target vessels with normal renal function.

Conclusion: The use of adjunctive hybrid procedures may optimize or facilitate FB-EVAR. In this patient, salvage of 2 small RAs was not ideally suited for branch stenting but was possible using modified ex vivo RA reconstruction with preservation of kidney parenchyma and function.

Clinical impact: This case report illustrates a hybrid approach to overcome one of the most frequent limitations to total endovascular incorporation of renal arteries, eg small diameter, early bifurcation and multiple vessels. The modified ex vivo technique allows meticulous renal artery reconstruction without the deleterious effect of warm ischemia and without the cumbersome reconstruction of ureter and vein that is needed with traditional on table ex vivo auto transplantation. The technique is used in a minority of cases and adds the morbidity of open approach. Case selection is of paramount importance.

Clinical impact: Digital subtraction angiography (DSA) has traditionally been considered an effective method for visualizing carotid free-floating thrombus (CFFT), but it falls short in providing detailed structures of the lumen and the composition of thrombi, making it challenging to determine the etiology. Intravascular optical coherence tomography (OCT) is a valuable adjunct to DSA that can precisely evaluate the characteristics of the intrinsic vessel wall and accurately distinguish between red and white thrombus, providing clues to the etiology of CFFTs. Moreover, OCT not only precisely determined the scope of a floating thrombus but also provided guidance for decision-making in endovascular treatment.