Five-year follow-up of randomized clinical trial for pre-emptive inferior mesenteric artery embolization during endovascular aneurysm repair.

OBJECTIVE: Type II endoleak (T2EL) is the most common type of endoleak after endovascular aneurysm repair (EVAR) and a common indication for reintervention due to late sac enlargement. Although pre-emptive embolization of the inferior mesenteric artery (IMA) has been proposed to prevent this, no studies have prospectively demonstrated its efficacy. This study aimed to prove the validity of IMA embolization during EVAR in selective cases by analyzing the mid-term outcomes of a randomized clinical trial (RCT). METHODS: This single-center, parallel-group, non-blinded RCT included participants at high risk of T2EL, characterized by a patent IMA in conjunction with one or more following risk factors: a patent IMA ≥3 mm in diameter, lumbar arteries ≥2 mm in diameter, or an aortoiliac-type aneurysm. The participants were randomly assigned to two groups in a 1:1 ratio: one undergoing EVAR with IMA embolization and the other without. The primary endpoint was T2EL occurrence. The secondary endpoints included aneurysm sac changes and reintervention. In addition to RCT participants, outcomes of patients with low risk of T2EL were also analyzed. RESULTS: The embolization and non-embolization groups each contained 53 patients. Five-year follow-up after the last patient enrollment revealed that T2ELs occurred in 28.3% and 54.7% of patients in the IMA embolization and non-embolization groups, respectively (P = .006). Both freedom from T2EL-related sac enlargement ≥5 mm and cumulative incidence of sac shrinkage ≥5 mm were significantly higher in the IMA embolization group than in the non-embolization group (95.5% vs 73.6% at 5 years; P = .021; 54.2% vs 33.6% at 5 years; P = .039, respectively). The freedom from T2EL-related sac enlargement ≥10 mm, an alternative indicator for T2EL-related reintervention, showed similar results (100% vs 90.4% at 5 years; P = .019). Outcomes in the low-risk group were preferable than those in the non-embolization group and comparable to those in the IMA embolization group. CONCLUSIONS: A lower threshold for pre-emptive IMA embolization when implementing EVAR would be more appropriate if limited to patients at high risk of T2ELs.

Efficacy of Airbo·Wave in Nighttime Compression for Leg Lymphedema.

Objectives: This study aimed to clarify the efficacy of Airbo·Wave EV1 in nighttime compression therapy as part of complex decongestive therapy (CDT) for leg lymphedema. Patients and Methods: We retrospectively reviewed 33 patients with leg lymphedema who used Airbo·Wave EV1 between April 2021 and September 2022. In these patients, the changes in leg volume and skin hardness were assessed using a scale ranging from 1 (softest) to 7 (hardest), and dermal thickness before and after the use of Airbo·Wave EV1 was evaluated. Results: Twenty-two patients used Airbo·Wave EV1 for nighttime compression in CDT. Their skin hardness in the lower calf decreased mildly (mean scale: before, 3.9; after, 3.6 [p <0.05]), but the leg volume and skin thickness were unchanged. Eleven patients who were nonadherent could restart compression therapy by using Airbo·Wave EV1. Their skin hardness in the medial lower calf (before, 5.1; after, 4.3 [p <0.05]), leg volume (before, 8412 mL; after, 8191 mL [p <0.01]), and skin thickness in the medial and lateral lower leg were reduced. Conclusion: Airbo·Wave EV1 could improve skin hardness in the calf area. Moreover, it is a safe procedure for the nonadherent while reducing leg volume reasonably.

Time-Dependent Changes of Extremity Volume and Tissue Alterations in Swollen Arms Caused by Taxanes.

Background: We aimed to determine the course of arm swelling caused by the use of taxanes and to identify valid predictors of persistent swelling. Methods and Results: A total of 15 patients with unilateral arm swelling that developed during the course, or within 3 months after termination, of postoperative taxane-based chemotherapy were included in the present study. The patients attended follow-up appointments every 3-6 months for 24 months after their initial visit. Their arm circumference was measured at each follow-up appointment, while ultrasonography of the skin and subcutaneous tissues was performed at the 0-, 6-, 12-, and 24-month follow-ups. Of the 15 patients, 12 (80%) saw their taxane-induced arm swelling resolved within a median of 12 months (range, 3-29 months) after their final taxane administration. Of the 12 patients whose swelling resolved, 9 did not use compression sleeves; however, their course of resolution did not differ from the other 3 patients who regularly used compression sleeves. In the three patients with persistent swelling, the excess subcutaneous thickness in the medial upper arm (median, 283%) was significantly greater than that in the patients whose swelling resolved (120%; p < 0.05) during their initial visits. Conclusions: Of the 15 patients included in the present study, 80% saw their taxane-induced arm swelling resolve within a median of 12 months after their final taxane administration, independent of the use of compression therapy. Persistent swelling may be predicted during the initial visit based on subcutaneous thickening of the medial upper arm.

Dependent Leg Edema in Older Patients with or without Skin Lesion.

Objective: This study aimed to clarify the features and causes of dependent edema (DE) in the legs of patients in geriatrics. Patients and Methods: We retrospectively reviewed 224 patients with DE, aged ≥65 years, who visited our clinic from April 2009-March 2022. DE was defined as bilateral leg edema in patients without known systemic edemagenic conditions, venous insufficiency confirmed by duplex venous scanning, or a cancer treatment history in the pelvic/inguinal lesions. Results: The median patient age was 77 years (range: 65-94 years), where 74% were female. Overall, 198 patients (88%) had gait disturbances caused mainly by musculoskeletal disorders, but 58 (26%) walked without aid. Compared with patients with DE only (N=129), patients with DE and venous stasis-related skin lesions (N=95) included a larger number of those with obesity than did those with DE only (26% vs. 14%, p=0.02). Conclusion: The primary cause of DE in older patients was the sedentary lifestyle secondary to aging and gait disturbance, not solely because of reduced leg function. The complications of obesity are associated with increased venous stasis-related skin lesions.

Leg volume reduction during tiptoe movement is caused by venous ejection and calf muscle contraction.

OBJECTIVES: To clarify the cause of leg volume reduction during tiptoe movement in the standing position. METHODS: The right legs of 20 participants were assessed. The participants performed tiptoe movement in the supine position, and then stood up and performed the tiptoe movement and ankle dorsiflexion. Leg volume changes were recorded continuously using air plethysmography. RESULTS: Differences between leg volume changes due to tiptoe movement and the refilling volumes were not significantly different between the supine (59 mL) and standing (49 mL) positions, indicating that this amount of motion artifact was included in the downward trace recorded by tiptoe movement in the standing position. CONCLUSIONS: Leg volume reduction during tiptoe movement in the standing position included a significant amount of motion artifacts. Therefore, it may be difficult to accurately measure the ejection volume using tiptoe movement in the standing position.

Post-treatment course of acute lipodermatosclerosis.

OBJECTIVES: We aimed to clarify whether acute lipodermatosclerosis (LDS) progress to chronic LDS without continued compression therapy. METHODS: Between April 2015 and November 2021, 30 patients with acute/subacute LDS, which was diagnosed clinically by presence of isolated, poorly demarcated, tender erythema, and induration limited to the lower leg(s), visited our clinic and were able to be followed up for longer than a year. We reviewed their treatment results and the post-treatment courses. RESULTS: In all cases, the symptoms in the acute phase subsided with compression bandages. After the discontinuation of compression therapy, 18 legs (56%) progressed to chronic LDS, and 14 legs (44%) did not. In the legs without progression, subcutaneous tissue in the affected leg was thicker compared with that in the contralateral leg (median 19.1 mm vs. 13.4 mm, p < 0.05) on the initial visit. In the legs with progression, the difference in subcutaneous tissue thickness between the affected and unaffected legs was not significant (10.0 mm vs. 7.6 mm). CONCLUSIONS: Our findings suggest that in legs which later progress to chronic LDS, subcutaneous tissue contraction due to panniculitis is already present during the acute phase; therefore, long-term compression therapy is unlikely to improve the prognosis.

Cryopreserved allogenic fibroblast sheets: development of a promising treatment for refractory skin ulcers.

The purpose of this study was to investigate the therapeutic effect of cryopreserved allogenic fibroblast cell sheets in a mouse model of skin ulcers. It is necessary to reduce the cost of regenerative medicine for it to be widely used. We consider that cell sheets could be applied to various diseases if cryopreservation of allogenic cell sheets was possible. In this study, fibroblasts were frozen using a three-dimensional freezer. Freeze-thawed fibroblasts had ~80% cell viability, secreted ≥ 50% vascular endothelial growth factor, hepatocyte growth factor, and stromal derived factor-1α compared with non-frozen fibroblast sheets, and secreted approximately the same amount of transforming growth factor-ß1. There was no difference in wound-healing rates in the skin ulcer model between non-frozen and freeze-thawed fibroblast sheets regardless of autologous and allogenic cells. The degree of angiogenesis was comparable between autologous and allogenic cells. The number of CD3-positive cells in healed tissues was larger for allogenic fibroblast sheets compared with autologous fibroblast sheets. However, histopathological images showed that the fibrosis, microvascular density, and healing phase of the wound in allogenic freeze-thawed fibroblast sheets were more similar to autologous freeze-thawed fibroblast sheets than to allogenic non-frozen fibroblast sheets. These results suggest that allogenic freeze-thawed fibroblast sheets may be a promising therapeutic option for refractory skin ulcers.

Effects of leg compression and calf muscle contraction by active ankle motion on venous hemodynamics in sitting individuals.

OBJECTIVES: To clarify the effects of compression and active ankle motion on venous hemodynamics in healthy sitting individuals. METHODS: In the sitting position, 14 participants performed plantar flexion and dorsiflexion of the ankle for 3 s each without compression. Changes in the calf volume were recorded using air plethysmography. Subsequently, the process was repeated with the application of tubular elastic bandage (TEB), followed by anti-thrombotic stocking (ATS). RESULTS: The median interface pressure at the calf was 16 mmHg with TEB and 21 mmHg with ATS. Without compression (N), the median venous volume was 76 mL. This was reduced to 58 mL with TEB and 56 mL with ATS (p < .01 vs. N for both). On the other hand, ejection volume by plantar flexion in N (27 mL) was not significantly changed with TEB (31 mL) or ATS (31 mL). Also, ejection volume by dorsiflexion in N (53 mL, p < .001 vs. plantar flexion) was not significantly changed with TEB (53 mL, p < .01 vs. plantar flexion) or ATS (41 mL, p < .05 vs. plantar flexion). CONCLUSIONS: The venous volume, which is defined as the change in enclosed calf volume from elevation to dependency, in the sitting position reduced similarly with TEB and ATS; however, the ejection volumes did not change significantly. Dorsiflexion exerted a larger ejection volume than plantar flexion in the sitting position.

Perivascular Adipose Tissue Is a Major Source of Nitric Oxide in Saphenous Vein Grafts Harvested via the No-Touch Technique.

Background Saphenous vein grafts (SVGs) are broadly used in coronary artery bypass grafting despite their inferior patency compared with arterial grafts. Recently, the no-touch technique (NT), in which an SVG is harvested with a pedicle of perivascular adipose tissue (PVAT) without conduit distension, was shown to improve long-term patency compared with conventional preparation (CV), wherein outer tissue is removed with distension. The NT was also reportedly associated with reduced atherosclerosis. Although endothelial damage provoked by conventional distension may underlie poor patency when CV is performed, the precise mechanisms underlying the salutary effects of the NT have been unclear. Methods and Results Residual SVGs prepared with CV (CV-SVGs) or NT (NT-SVGs) were obtained during coronary artery bypass grafting. Nitric oxide (NO2-/NO3- (NOx)) levels after 24 hours of tissue culture were quantified. The protein expression and localization were analyzed. The isometric force of SVG strips was measured. NT-SVGs showed superior NOx production to CV-SVGs. PVAT generated the majority of NOx in NT-SVGs. PVAT highly expressed arginosuccinate synthase 1, a rate-limiting enzyme in the molecular circuit for NO synthesis, thereby continuously providing the substrate for NO. A substantial level of endothelial NO synthase was also expressed in PVAT. Pharmacological inhibition of arginosuccinate synthase 1 or endothelial NO synthase significantly suppressed the NOx production in NT-SVGs. PVAT induced vasorelaxation through NO production, even in the endothelium-denuded SVG strips. Conclusions Preserving PVAT was predominantly involved in the superior NOx production in NT-SVGs. Since NO plays crucial roles in suppressing atherosclerosis, this mechanism may greatly contribute to the excellent patency in NT-SVGs.

Hardness Sensed by Skin Palpation in Legs with Lymphedema Is Predominantly Correlated with Dermal Thickening.

Background: We aimed to clarify whether pathological changes in skin and subcutaneous tissue with lymphedema affected the skin hardness sensed by palpation. Methods and Results: In 50 patients with unilateral legs with lymphedema (LE), the skin hardness of the lower inner thigh and lower inner calf was determined using a scale ranging from 1 (softest) to 7 (hardest) based on palpation. Then, the skin hardness was correlated with the measurements of skin/subcutaneous tissue ultrasonography images obtained from the palpated parts. Multivariate logistic regression analysis demonstrated that dermal thickness was a significant factor that affected the difference in skin hardness between the LE and the contralateral asymptomatic leg for both thigh (p < 0.05) and calf (p < 0.01). When the thigh and calf in the LE were individually studied, subcutaneous echogenicity (p < 0.05), indicating subcutaneous inflammation/fibrosis, and subcutaneous thickness (p < 0.01) also seemed to affect skin hardness, respectively. Conclusions: The skin hardness sensed in the LE seemed to be affected predominantly by dermal thickening. In addition, the pathological changes in the subcutaneous tissue caused by LE seemed to have an impact on skin hardness. Clinical Trial Registration number 2020-150.

Hyperbaric Oxygen Therapy Is an Effective Adjunctive Therapy to Manage Treatment-Resistant Venous Leg Ulcers.

We report five cases of venous leg ulcers (VLU) that were resistant to conservative therapy for 22-119 months and were eventually healed via hyperbaric oxygen therapy (HBOT). In one patient, VLU recurred four times and was managed using HBOT, each time. The VLU sizes ranged from 18 to 68 cm2 before HBOT. HBOT was administered at 2.0 atmospheres absolute with 100% oxygen for 60 min per session, five sessions a week during hospitalization. All VLUs healed after 17-66 sessions of HBOT.

A pilot study using cell-mixed sheets of autologous fibroblast cells and peripheral blood mononuclear cells to treat refractory cutaneous ulcers.

BACKGROUND/AIMS: We invented a cell-mixed sheet consisting of autologous fibroblast cells and peripheral blood mononuclear cells (PBMNCs) to treat refractory cutaneous ulcers. These sheets secrete the growth factors needed throughout the wound healing process in animal models. METHODS: We performed this study as a pilot phase I clinical trial (UMIN-CTR: UMIN000031645). Fibroblast cells were isolated and cultured from the oral tissue, and PBMNCs were collected by apheresis. A cell-mixed sheet was prepared by co-culturing these collected cells for 3 days. The primary observation index was safety, including all adverse events. Additional observation indices were wound healing over 1, 3, and 6 months; wound healing rate at 7 days and 1, 3, and 6 months. RESULTS: Six patients with venous leg ulcers (VLUs) were enrolled in the study, including three patients who were treated with the cell-mixed sheet transplantation. One patient was excluded because no fibroblast cells grew from the oral tissue culture, and other two were excluded because the growth factor secreted from mixed-cell sheets did not reach the reference value. The VLUs of two patients who received the cell-mixed sheet transplantation healed, and the VLU in one patient decreased in size. CONCLUSIONS: This pilot study demonstrated that cell-mixed sheets might be a new topical intervention to treat VLUs. However, it was also suggested that this treatment might be limited when using autologous cells collected from patients with VLUs. Therefore, it may be necessary to use high-quality allogeneic cells instead of autologous cells to improve the feasibility of this treatment.

Treatment Results of Endovascular Aneurysm Repair Using the Parallel Stent-Graft Double D Technique for Distal Saccular Abdominal Aortic Aneurysms and Common Iliac Aneurysms.

BACKGROUND: Endovascular aneurysm repair (EVAR) using a bifurcated stent graft may involve technical challenges when aortic disease (aneurysm or dissection) consists of a length <70 mm between the inferior renal artery and aortic bifurcation or narrow aortic bifurcation that is common in asymmetric distal abdominal aortic aneurysms (AAAs) or iliac artery aneurysms (IAAs). We use EVAR with the double D technique (DDT-EVAR) for such cases, which involves straight type of stent grafts with same diameter in left and right that are deployed parallel to an aortic cuff that has been previously placed. In addition, DDT-EVAR can preserve the inferior mesenteric artery (IMA) for IAA. METHODS: DDT-EVAR was performed for 21 of 910 (2%) cases from April 2007 to April 2019 at our institution. The median patient age was 74 years (range, 52-85). Nineteen patients (90%) were men. Six patients (all saccular; 1 rupture) had AAAs, 12 had IAAs, and 3 had chronic type B aortic dissociation (TBAD) for re-entry closure. AAA and IAA had diameters of 45 mm (range, 34-71) and 34 mm (range, 25-58), respectively. An aortic cuff was used for 19 (90%) cases. Endurant II (Medtronic, Santa Rosa, CA) was used for 12 cases. The Excluder (W.L. Gore & Associates, Inc, Flagstaff, AZ) was used for 7 cases. Endurant II was used for 20 cases, and the VBX (W.L. Gore & Associates, Inc) was used for 1 case as stent-graft limbs. RESULTS: The procedural success rate was 100%. The median operative time was 146 min (range, 88-324). IMA planned for preservation was successful for all 12 cases. Type I and type III endoleaks were not observed. With TBAD, flow to the false lumen decreased or disappeared, and no complications during the hospital stay were associated with the procedure. For 2 patients whose procedure involved Endurant II stent-graft limb, limb occlusions were observed postoperatively, and reintervention was required. No other patients required additional treatment at a median follow-up of 18 months (range, 4-50). CONCLUSIONS: DDT-EVAR is a safe and straightforward technique for the treatment of distal AAA, common iliac artery aneurysm, and TBAD. It may help preserve the IMA and internal iliac artery, even when it is impossible to preserve them with a bifurcated stent graft.

Extracellular Fluid Content in the Legs of Patients with Chronic Venous Disease.

BACKGROUND: This study aimed to determine the factors that affect the extracellular fluid (ECF) content in the legs of patients with chronic venous disease (CVD). METHODS: Bioimpedance analysis and air plethysmography (APG) were performed in 79 patients with CVD who visited our clinic between September 2016 and March 2019. The normal right legs (N) of 14 healthy volunteers were also reviewed for comparison. The ratio of ECF resistance (Re) of the leg to that of the arm (ReL/ReA) was used to express the ECF content in the tested leg. The severity of CVD was expressed using the clinical, etiological, anatomical, and pathophysiological (CEAP) classification. RESULTS: The ReL/ReA decreased as the CEAP class increased (N: median; 0.81 [range 0.66-0.95], C0-1: 0.79 [0.60-0.98], C2: 0.77 [0.56-1.08], C3: 0.67 [0.57-0.85], C4: 0.64 [0.44-0.89]). Older age, female sex, and CEAP class affected the ReL/ReA, but body mass index did not. The ReL/ReA did not correlate with the parameters that were derived from APG, including the venous filling index. CONCLUSIONS: We found that the ECF content in legs of patients with CVD might be primarily affected by patient-related factors and CEAP class, as opposed to venous hemodynamics.

Endovascular Aneurysm Repair With Re-entry Closure in a Patient With Abdominal Aortic Aneurysm Concomitant With Acute Type B Aortic Dissection.

INTRODUCTION: Abdominal aortic aneurysm (AAA) concomitant with acute aortic dissection is rare. CASE REPORT: An acute type B aortic dissection involving AAA in a 58 year old woman is described. Computed tomography angiography demonstrated that the false lumen of the abdominal aorta including the aneurysm remained patent, secondary to entry sites in the abdominal aorta, bilateral external iliac arteries, and a membrane tear of the left renal artery (LRA). The aneurysm was isolated by endovascular aneurysm repair and LRA stenting; all entry sites were occluded by endovascular treatment that included covered stenting of the LRA. Imaging performed three months after the procedure confirmed complete thrombosis of the false lumen and AAA sac shrinkage. DISCUSSION: Endovascular treatment with covered stents is reported as an alternative strategy for treatment of AAA concomitant with acute aortic dissection involving a visceral artery.

Allogeneic fibroblast sheets accelerate cutaneous wound healing equivalent to autologous fibroblast sheets in mice.

BACKGROUND/AIMS: This study sought to confirm the difference of the wound-healing effect, cell survival, and immune response between autologous fibroblast sheets and allogeneic fibroblast sheets. METHODS: Regarding wound healing, autologous or allogeneic fibroblast sheets were transplanted onto a mouse cutaneous wound healing model and the wound contraction rate was evaluated. The luciferase-expressing fibroblast sheet was prepared and the survival of the cell sheet was evaluated by IVIS® after autologous or allogeneic transplantation. Histological evaluation was performed at five and 14 days after transplantation. RESULTS: Allogeneic fibroblast-sheet transplantation showed significant wound contraction at the early phase of wound healing, which was equivalent to that seen with the autologous fibroblast sheets. Luminescence of the autologous and allogeneic luciferase-expressing fibroblast sheets peaked on Day 5, and no luminescence was observed on Day 13. In the allogeneic fibroblast-sheet transplant group, a significant accumulation of immune cells was observed in the healed tissue but not in the early stage of wound healing. CONCLUSION: The allogeneic fibroblast sheets showed comparable rates of cell survival and wound-healing effects to those of the autologous fibroblast sheets, despite the subsequent immunogenic response. This result supports the potential practical clinical application of scaffold-free allogeneic fibroblast sheets based on the paracrine effect.

Interface Pressures Derived from a Tubular Elastic Bandage.

Objective: We sought to clarify the interface pressure (IP) when using a tubular elastic bandage (TEB) and examine the possibility for TEBs to provide IPs comparable to those provided by anti-thrombotic stockings. Materials and Methods: In 40 healthy patients, IPs were measured at the level of calf at its maximum diameter (C) and transition of the medial gastrocnemius muscle into the Achilles tendon (B1) while a single or double layer of TEBs (17.5 cm in circumference) were applied with the patient in a supine position. Results: Including both the C and B1 levels, circumferences and IPs showed a good correlation (single layer; r=0.72, double layer; r=0.75). The IP obtained with a single layer of TEB at the C level (median, 17 mmHg [range, 12-23 mmHg]) was higher than that at the B1 level (14 mmHg [11-18 mmHg], p<0.001). When double-layer TEB was used, the IP at B1 level increased to 18 (14-23) mmHg (p<0.001 vs. single layer). Conclusion: Considering the characteristics of TEBs and using a single or double layer appropriately, creating a pressure profile mimicking that of an anti-thrombotic stocking seemed to be feasible when using a TEB.

Regular Compression Therapy May Not Be Necessary for Lymphedema in Arms without a Subcutaneous Echo-Free Space.

BACKGROUND: To study the effect of prolonged complex decongestive therapy (CDT) on lymphedema in arms without a subcutaneous echo-free space (SEFS) on subcutaneous tissue ultrasonography. METHODS: Fifty-one patients with arm lymphedema treated for longer than 1 year using CDT in our clinic were retrospectively evaluated. Before starting CDT, subcutaneous tissue ultrasonography was performed to examine for the presence of an SEFS. Two-stage CDT was performed as recommended by the International Society of Lymphology. Limb circumference was measured, and limb volume was calculated at the initial and latest visits. RESULTS: In patients with lymphedema in which SEFS was observed anywhere in the arm on the initial visit (n = 25), the edema ratio was significantly reduced by a median of -15% (range, -106% to 17%; P < 0.001). On the other hand, in the arms with lymphedema in which SEFS was not observed (SEFS[-], n = 26), the edema ratio was not changed significantly by CDT (median, 1% [range, -30% to 23%]). In arms without an SEFS that were not treated using arm sleeves regularly (n = 15), no increase in edema ratio was observed (median, 1% [range, -29% to 16%]). CONCLUSIONS: In arms with lymphedema without SEFS, the effect of CDT on the reduction of arm volume is limited.

Endovascular Aneurysm Repair With Inferior Mesenteric Artery Embolization for Preventing Type II Endoleak: A Prospective Randomized Controlled Trial.

OBJECTIVE: This study aimed to evaluate the effect of inferior mesenteric artery (IMA) embolization during endovascular aneurysm repair (EVAR) in patients at high risk of type II endoleak (T2EL) in randomized controlled trial (RCT). SUMMARY BACKGROUND DATA: Several studies have demonstrated a reduction of T2EL by IMA embolization before EVAR. However, there have been no RCT confirming the efficacy of IMA embolization. METHODS: Patients scheduled for elective EVAR between April 2014 and March 2018 were eligible. Patients at high risk of T2EL (IMA patency with IMA ≥3 mm, LAs ≥2 mm, or an aortoiliac-type aneurysm) were prospectively randomized to receive EVAR with or without IMA embolization. The primary endpoint was occurrence of T2EL during follow-up. Secondary endpoints included aneurysmal sac changes, adverse events from IMA embolization, and reintervention rate due to T2EL. This trial is registered with the University Hospital Medical Information Network, number UMIN000022147. RESULTS: One hundred thirteen patients had high risk and 106 were randomized. In the intention-to-treat analysis, the incidence of T2EL was significantly lower in the embolization group [24.5% vs 49.1%; P = 0.009, absolute risk reduction = 24.5%; 95% confidence interval (CI), 6.2-40.5, number needed to treat = 4.1; 95% CI, 2.5-16.1]. The aneurysmal sac shrunk significantly more in the embolization group (-5.7 ±â€Š7.3 mm vs -2.8 ±â€Š6.6 mm; P = 0.037), and the incidence of aneurysmal sac growth related to T2EL was significantly lower in the embolization group (3.8% vs 17.0%; P = 0.030). There were no complications related to IMA embolization or reinterventions associated with T2EL. CONCLUSIONS: Our results demonstrated the effectiveness of IMA embolization during EVAR in high-risk patients for the prevention of T2EL, which is suggested for avoiding aneurysmal sac enlargement related to T2EL.

Perioperative variations in indices derived from noninvasive assessments to detect postmastectomy lymphedema.

OBJECTIVE: This study aimed to clarify the variations in indices derived from noninvasive assessments for the early detection of postmastectomy lymphedema (LE) from 1 month preoperatively until 2 years postoperatively. METHODS: In total, 120 patients who underwent surgery for breast cancer in our institution were prospectively followed up with a questionnaire for arm swelling as well as with tape measurements, bioimpedance analysis (BIA), and skin and subcutaneous tissue ultrasound at 1 month before and 3, 6, 12, 18, and 24 months after surgery. RESULTS: Ninety-seven patients completed the study. Among 93 patients who did not present with LE, 9% complained of arm swelling even before surgery, and the incidence peaked at 17% at 6 months after surgery. There were no differences in the circumferences of the upper arm, forearm, and hand between sides throughout the study period. However, the postoperative circumference values of the upper arm only on the operation side were slightly increased compared with the preoperative values. The mean excess fluid in the arm on the operation side compared with the contralateral side, as assessed by BIA, was nearly zero throughout the study period. There were no differences in subcutaneous echogenicity or skin and subcutaneous thicknesses between the sides throughout the study period. However, time-dependent increases in subcutaneous thicknesses were noticed on both sides. Four patients (4.1%) developed LE. In three of these patients, abnormality in the BIA was recorded 6 to 12 months before presentation. Immediately after presentation, the common findings included BIA abnormality and increased subcutaneous echogenicity and skin thickness in the medial forearm. CONCLUSIONS: In this study, a complaint of arm swelling was not sensitive enough for detection of the early onset of LE because a certain number of patients constantly complained of this symptom. Measurements of circumference might help in the diagnosis of LE onset, but this method is not specific enough because these measurements are also affected by various factors. However, BIA and skin and subcutaneous ultrasound were identified as potential tools for the early detection of LE.