Purpose: In managing type 2 endoleak (T2EL) following endovascular aortic aneurysm repair (EVAR), an indication for reintervention is aneurysm enlargement (AnE). A previous study found that low D-dimer levels (DDLs) at 1 year were associated with reduced AnE risk in patients with persistent T2ELs (pT2ELs). This study analyzed patients with pT2ELs to determine the correlation between DDLs at annual follow-ups and AnE and proposed a follow-up protocol incorporating DDL monitoring.
Methods: A retrospective review of elective EVAR cases between June 2007 and January 2021 identified "persistent" T2EL as confirmed at both 6- and 12-month contrast-enhanced CT studies. "Isolated" T2EL referred to cases without other endoleak types within 12 months. Inclusion criteria comprised >2 years of follow-up, isolated pT2ELs at 1 year, and DDL data at any annual follow-up over 5 years. The association between DDL and AnE, defined as ≥5 mm expansion within 5 years, was analyzed.
Results: A total of 109 patients with DDL data at 288 time points were enrolled. During a median follow-up of 49 months [31-60, IQR], 43 AnE were observed. In patients without AnE and with DDL data at 1 and 2 years (N=77 and 56), lower DDLs were associated with a reduced AnE risk (p=0.03 and 0.01). Optimal cutoff points were 5.4 and 5.3 µg/mL (AUC=0.651 and 0.702) with high negative predictive values (86.9% and 93.8%). Cox regression analyses confirmed that DDLs surpassing the cutoff values correlated significantly with AnE (p=0.042 and p=0.038). Our simulated protocol for omitting imaging studies in patients with stable aneurysms and low DDL might have overlooked one AnE but could have saved 28 imaging studies over 3 years if implemented on our patients.
Conclusion: Low DDLs at the 1- and 2-year follow-ups can potentially exclude AnE in pT2EL patients, suggesting DDL monitoring as a resource-saving approach.
Clinical impact: The management of type 2 endoleaks in post-EVAR patients has been a topic of debate. This retrospective single-center study, featuring strict inclusion criteria, included 109 patients with persistent type 2 endoleaks. The findings indicate that patients with lower D-dimer levels at 1- and 2-year follow-ups are unlikely to experience sac enlargement ≥5 mm within 5 years, even in the presence of type 2 endoleaks. This study suggests that D-dimer monitoring has the potential to reduce reliance on imaging studies for the follow-up of patients with type 2 endoleaks, leading to significant savings in medical resources.
Objective: To analyze the clinical efficacy of long-term statin therapy following thoracic endovascular aortic repair (TEVAR) in patients with acute type B aortic dissection (ATBAD).
Methods: We retrospectively analyzed data from 645 patients treated between January 2005 and June 2022, dividing them into Statin Group (n=330) and Non-statin Group (n=315) based on whether they received long-term postoperative statin therapy. Patients were further categorized based on median admission low-density lipoprotein cholesterol (LDL-C) levels into High and Low LDL-C Groups to assess the effect of statins on the prognosis of ATBAD patients after TEVAR.
Results: The cohort had an average age of 53.44±11.42 years old, and 81.71% were male. Statin therapy significantly reduced occurrences of all-cause death (3.03% vs 8.57%, p=0.002) and aorta-related death (0.91% vs 3.81%, p=0.015), particularly in patients with high admission LDL-C levels. In addition, patients with statin therapy had a lower incidence of aorta-related adverse events (ARAE) (4.24% vs 11.11%, p=0.001). Kaplan-Meier analysis indicated statins reduced 5-year cumulative incidence rates of all-cause death and ARAE (all Log-rank p<0.05). These trends were sustained after adjustment. Multivariate Cox analysis confirmed that statin therapy was associated with reduced risks of all-cause and aorta-related deaths, as well as ARAE.
Conclusion: Long-term statin therapy appears to decrease the risk of all-cause and aorta-related death in ATBAD patients after TEVAR, particularly patients with high admission LDL-C levels. Patients with lower LDL-C levels at admission have a reduction of aorta-related death in the follow-up period. Statin therapy also was associated with a lower incidence of ARAE in follow-up. These findings suggest that statins might be crucial in improving long-term outcomes in this patient population.
Clinical impact: Long-term statin therapy administered to patients with acute type B aortic dissection (ATBAD) following thoracic endovascular aortic repair (TEVAR) demonstrates a substantial reduction in both all-cause and aorta-related mortality. Notably, this therapeutic benefit is most evident in patients presenting with elevated low-density lipoprotein cholesterol (LDL-C) levels at admission. Furthermore, statin therapy is associated with a decreased incidence of aorta-related adverse events during follow-up. These findings underscore the pivotal role of statin therapy in enhancing long-term clinical outcomes for ATBAD patients undergoing TEVAR, thereby contributing to improved patient care and prognosis.
Purpose: Previous studies have indicated mixed short-term outcomes between drug-coated balloon (DCB) angioplasty and percutaneous transluminal angioplasty (PTA) in the treatment of infrapopliteal lesions. However, the long-term durability of DCB angioplasty remains uncertain. The objective of this study is to present the long-term outcomes of DCB angioplasty for infrapopliteal lesions in patients with critical limb ischemia (CLI).
Materials and methods: The AcoArt II-BTK Trial was a prospective, multicenter, randomized, single-blinded trial that enrolled 120 patients with CLI. The patients were randomized 1:1 to DCB angioplasty or PTA. Assessments over 5 years included freedom from all-cause death, freedom from clinically driven target lesion revascularization, and occurrence of major amputation. Additional endpoints included the rate of composite major adverse events.
Results: Over 5 years, patients treated with DCB angioplasty demonstrated a higher rate of freedom from all-cause death than patients treated with PTA (Kaplan-Meier estimate 74.6% vs 57.2%; log-rank p=0.04). The major amputation rate was 5.2% for DCB angioplasty compared with 1.8% for PTA (log-rank p=0.347). Freedom from clinically driven target lesion revascularization was 70.5% and 53.7%, respectively (log-rank p=0.058). The rate of composite major adverse events was 34.5% for DCB angioplasty and 56.1% for PTA (log-rank p=0.013), and this statistically significant difference persisted throughout the 5-year follow-up period. Conclusion:Infrapopliteal artery revascularization in patients with CLI using Litos/Tulip DCB angioplasty showed superior 5-year overall survival compared with PTA. The DCB angioplasty group had a consistently lower rate of major adverse events within 5 years of follow-up.
Clinical impact: The use of DCB in infrapopliteal arterial lesions has been controversial regarding both early and mid-term outcomes, with limited data on long-term results. However, this article demonstrates that the Litos/Tulip DCB exhibits favorable long-term outcomes in infrapopliteal artery lesions. These positive findings provide robust evidence supporting the use of DCB in treating infrapopliteal artery disease.
Purpose: Previous clinical studies have reported on the short- and mid-term prognoses of thoracic endovascular aortic repair (TEVAR) using the GORE thoracic aortic graft (TAG) or conformable GORE TAG. We evaluated the long-term prognoses of patients who underwent TEVAR using the GORE TAG or conformable GORE TAG in a real-world setting.
Materials and methods: This retrospective observational study analyzed the data of all consecutive patients aged 20 years or older who underwent TEVAR using either the GORE TAG or the conformable GORE TAG at a single center. The surgical criteria did not deviate from global standards. In principle, TEVAR was performed with the TAG or conformable thoracic aortic graft (CTAG) according to the manufacturer's instructions. The primary outcomes of this study were the 10-year overall survival rate and the rate of freedom from aorta-related deaths at 10 years.
Results: Between January 2011 and December 2021, 331 patients underwent TEVAR, of whom 175 consecutive patients treated with TEVAR using either the GORE TAG or the conformable GORE TAG were enrolled. The mean age of the patients was 72.1 ± 9.3 years. In addition, the aneurysm and chronic dissection were 61.7% and 38.3%, respectively. Of all patients, 157 had a proximal landing zone ≥3, and 18 had a zone <3. The mean follow-up time was 46.5 ± 33.1 months. The 30-day mortality rate was 2.86%. The 3-, 5-, 7-, and 10-year overall survival rates were 76.9 ± 3.4%, 63.4 ± 4.1%, 55.9 ± 4.9%, and 42.4 ± 8.4%, respectively. The rate of freedom from aorta-related deaths at 3, 5, 7, and 9 years was 97.4 ± 1.3%, 95.0 ± 2.1%, 95.0 ± 2.1%, and 95.0 ± 2.1%, respectively. Late complications occurred in 23 (13.1%) patients. Endovascular re-intervention was performed because of endoleak, false lumen enlargement, or stent graft-induced new entry tear in 14 patients. Three patients required open conversion, and 6 were observed without re-intervention.
Conclusions: Thoracic endovascular aortic repair using the GORE TAG or conformable GORE TAG is a safe and effective procedure for the treatment of thoracic aortic aneurysms and aortic dissection.
Clinical impact: Thoracic endovascular aortic repair using the GORE thoracic aortic graft (TAG) or conformable GORE TAG is a safe and effective procedure for the treatment of thoracic aortic aneurysms and aortic dissection. The 30-day mortality rate was 2.86%. During 10 years of follow-up, the overall survival rate was low; however, the risk of aorta-related deaths was also low. No significant differences in freedom from late complications and re-intervention are seen between the TAG and conformable thoracic aortic graft (CTAG) groups. Further investigations into the treatment of late complications are required.
Purpose: We sought to investigate the mid-term and long-term efficacy of 1470 nm endovenous laser ablation (EVLA).
Material and methods: We conducted a systematic research on PubMed, Scopus, and Web of science for articles published by January 2024. The primary endpoints were truncal vein and great saphenous vein (GSV) occlusion.
Results: Fifteen studies, 4 randomized controlled trials (RCTs), 5 prospective, and 6 retrospective case series, including 2064 patients and 2125 truncal veins (1862 GSV) were included. The pooled truncal vein occlusion estimates at 2, 3, and 5 years were 93.51% (95% confidence interval [CI]: 90.01, 95.84), 89.60% (95% CI: 82.75, 93.93), 88.94% (95% CI: 81.59, 93.58). The pooled GSV occlusion at 2, 3, and 5 years were 93.90% (95% CI: 90.30, 96.21), 93.01% (95% CI: 82.80, 97.36), and 89.06% (95% CI: 80.55, 94.12), respectively. The pooled deep vein thrombosis (DVT) and burn estimates were 1.42% (95% CI: 0.87, 2.31) and 2.64% (95% CI: 1.19, 5.75), respectively. The pooled overall and permanent neurologic complication estimates were 4.33% (95% CI: 1.62, 11.12) and 1.70% (95% CI: 0.69, 4.13), respectively. The pooled Venous Clinical Severity Score (VCSS) reduction by the end of follow-up was, mean difference (MD), 4.96 (95% CI: 3.87, 6.05). Meta-regression analysis including linear endovenous energy density (LEED) values ranging from 69 to 101.7 J/cm elucidated a statistically significant positive association between LEED and GSV occlusion at the 2-year (β=0.0977, p=0.02), 3-year (β=0.2021, p<0.01) and 5-year (β=0.0534, p=0.01) follow-up intervals.
Conclusion: This review has displayed satisfactory medium and long-term truncal and GSV occlusion outcomes for the 1470 nm device. In addition, a positive association between GSV occlusion and LEED was identified, persisting through the 2-year, 3-year, and 5-year follow-up intervals. Despite these favorable findings further research is imperative, focusing not only on technical aspects, such as vein occlusion but also on critical clinical parameters, including varicose vein recurrence, to comprehensively evaluate the effectiveness and durability of EVLA.
Clinical impact: This review demonstrated the efficacy and safety of the 1470 nm EVLA device in the treatment of lower limb venous insufficiency over the medium- and long-term periods, further substantiating its continued use. Moreover, the consistent positive association between linear endovenous energy density (LEED) and occlusion outcomes across the five-year follow-up interval highlighted the critical role of LEED in optimizing long-term clinical results, potentially offering valuable insights for practitioners.
Background: Published reports demonstrate that the use of Castor stent-graft is a promising treatment of aortic pathologies with the need to land in zone 2. However, there is a lack of publications on the medium-term results of Castor in the European population. This research evaluates the mid-term results of the Castor stent-graft in several Polish centers for the treatment of aortic pathologies and enriches the current knowledge of Castor stent-grafts.
Material and methods: Twenty-one patients from 5 polish vascular surgery centers in subacute phase of type B aortic dissection (TBAD) with at least 1 classic risk factor of aneurysmatic degeneration, thoracic aortic aneurysms (TAAs) exceeding 5.5 cm, subacute phase of intramural hematomas (IMHs) and penetrating aortic ulcerations (PAUs) with at least 1 indication to endovascular treatment. Structure of the aortic arch and factors of aneurysmal degeneration for TBAD were highlighted. Early complications, long-term complications, and reinterventions after Castor device implantation are reported in the study.
Results: Twenty (95.24%) patients survived, of which a technical success involving implantation of the Castor device in the correct location with a patent branch for the left subclavian artery, and no endoleaks were noted in 19 (90.48%) patients. After the procedure, there were 2 (9.52%) cases of type I endoleak (in which technical success was not achieved) and 2 (9.52%) cases of bird beak. In addition, 1 case of access site hematoma, 1 case of pseudoaneurysm, and 1 case of access iliac artery rupture requiring implantation of a Viabahn device were observed. During the follow-up period (mean 14 months; range = 1-40 months), 1 patient required reintervention due to type I endoleak and 1 patient due to left subclavian artery (LSA) branch thrombosis. Two patients required subsequent branched endovascular aortic repair procedure due to unfavorable remodeling and fast aneurysm formation in visceral aorta, regardless of Castor results.
Conclusion: The Castor device is an easy-to-use stent-graft with good medium-term results. It is an excellent option in cases requiring LSA revascularization during TEVAR.
Clinical impact: In this study, we investigate the medium-term results of the Castor stent graft in patients with type B aortic dissection, thoracic aortic aneurysm, intramural hematoma and penetrating aortic ulceration. The medium-term results of treatment with the Castor device are not yet well studied. Currently, there are only a small number of publications on the safety, complications and success of Castor device implantation.
Clinical impact: The outcomes of local anesthesia and sedation (also referred to as monitored anesthesia care) in endovascular aortic arch repair are not well-studied or widely reported. This study aims to demonstrate the feasibility and safety of this approach using physician-modified endografts for total aortic arch repair and showing it is a promising alternative to general anesthesia. Only a few exclusion criteria necessitate performing the procedure under general anesthesia and no conversions to general anesthesia were required.
Purpose: Most clinical trials of drug-coated balloon (DCB) for the treatment of femoropopliteal artery stenosis chose 12-month primary patency rate (PPR) or 6-month late lumen loss (LLL) as the primary endpoint. It is still debatable whether 6-month LLL can be served as an appropriate surrogate endpoint for 12-month PPR. This study aimed to identify whether LLL can serve as an appropriate surrogate endpoint in peripheral DCB clinical trials, and shed light on the selection of primary outcome for subsequent confirmatory clinical trials of DCB in the treatment of femoropopliteal artery stenosis.
Materials and methods: The linear regression model was used to evaluate the correlation between 12-month PPR and 6-month LLL. Pooled standardized mean differences (SMDs) and relative gain between the DCB and plain old balloon angioplasty (POBA) group were computed to assess the consistency and surrogacy, using fixed or random effect model as appropriate. The coefficient of variation (CV) was calculated for both endpoints to compare their degree of variation overall and at study level.
Results: A total of 34 studies are eligible for this study. A significant negative linear correlation was found between 12-month PPR and 6-month LLL (R2=0.67, slope=-0.309, p=0.007). The SMD (DCB-POBA) of LLL and PPR was -0.76 (95% confidence interval [CI]: -0.98, -0.54), and 0.59 (95% CI: 0.46, 0.72) (p=0.18). The pooled relative gain of PPR (43%, 95% CI: 35%, 50%) was significantly lower than that of LLL (72%, 95% CI: 61%, 84%) (p<0.001). Coefficient of variation of LLL was larger than that of PPR overall in DCB and POBA groups.
Conclusion: Although a significant moderate correlation was observed between 12-month PPR and 6-month LLL, PPR shows more conservative and robust than LLL, which may exaggerate clinical benefits. Late lumen loss should be used discreetly depending on different situations and clinical benefits for patients.
Clinical impact: This study addresses the critical issue of primary endpoint selection in clinical trials of drug-coated balloon for femoropopliteal artery stenosis. By elucidating the moderate correlation between 6-month late lumen loss (LLL) and 12-month primary patency rate (PPR), the findings underscore the limitations of LLL as a surrogate endpoint due to its variability and potential to overstate clinical benefits. The study advocates for the use of 12-month PPR as a more robust and conservative endpoint in pivotal trials, particularly for novel devices. These findings provide clinicians with a nuanced understanding of outcome measures, promoting evidence-based decision-making and regulatory alignment to ensure patient benefits in vascular interventions.
Clinical impact: Ultrasound visualization of vascular closure devices during endovascular access closure leads to a significant decrease in overall and major post interventional access site complications. This non-invasive and often readily available imaging technique could therefore lead to an important decrease in morbidity and subsequent overall health care costs when added to the standard intervention protocol. With the increasing use of endovascular techniques to treat peripheral artery disease, the addition of ultrasound-techniques in closure of endovascular access sites could potentially have a large clinical impact, both on patient outcomes as well as financial outcomes.
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