Early outcomes of endovascular repairs of the aortic arch using thoracic branch endoprosthesis.

OBJECTIVE: The only commercially available thoracic branched endoprosthesis (TBE) for treatment of the aortic arch was released in 2022. Limited data outside of clinical trial results have been reported. This study describes the demographics, anatomic details, and outcomes for patients treated for zone 0 to 2 using TBEs outside of a clinical trial. METHODS: All patients treated using TBEs for zone 0 to 2 were included. Patients treated as part of the clinical trial for zone 0 to 1 (n = 6) were excluded. Patient demographics, comorbidities, anatomic and operative details, and outcomes were reported. Outcomes and survival were then compared between groups. RESULTS: Of 40 patients, six patients underwent repair of zone 0, three of zone 1, and 31 of zone 2. There were no differences in demographics, comorbidities, or operative details by zone of treatment; however, the frequency of genetic aortopathy differed (zone 0: 0%; zone 1: 67%; and zone 2: 6.4%; P < .01). Seventy-three percent of patients were treated for dissection vs 27% with isolated aneurysms. Of the patients, 2.5% were treated for rupture, 22% were treated for symptomatic aneurysms, and 75% were treated electively. Forty-eight percent of repairs included a proximal cuff, and 83% received distal extension. Technical success was achieved in 100% of patients. Mean fluoroscopy time was 18 minutes, and median fluoroscopy dose was 416 mGy. Sixty percent of patients had prior aortic ascending/arch repair. TBE was planned as part of a complete thoracoabdominal repair in 45% of patients. Thirty-day mortality was 2.5% overall, with a single death in a zone 0 patient that occurred at day 1 due to a myocardial infarction. There were no reinterventions within 30 days. All other outcomes were similar. The 30-day stroke rate was 5.0%. The strokes occurred at day 6 (zone 1) and day 15 (zone 2); however, both were due to occlusion of a prior proximal surgical bypass and unrelated to the TBE side branch or embolization. Specifically, both patients had occlusion of a branch of their prior zone 1 or zone 2 arch replacement. An endoleak occurred in 7.5% of patients at 30-day follow-up (type II: 5.0%; unknown: 2.5%). At a mean follow-up of 6.6 months, 100% of side branches were patent. CONCLUSIONS: Repair of the aortic arch including TBE can be performed electively and urgently with acceptable stroke and death rates. TBE provides a valuable tool for patients requiring complete repair of a thoracoabdominal aneurysm. Continued investigation is underway to assess long-term safety and efficacy outside of the clinical trial.

Five-year outcomes for bell bottom, iliac branch endoprosthesis, and coil and cover approaches from the GREAT registry.

OBJECTIVE: There are a variety of methods used today to treat common iliac aneurysms with endovascular techniques. Of these approaches, little is known about whether a particular limb strategy influences endoleak, reintervention, or aneurysm regression rates. We present 5-year data comparing endoleak, stent graft migration, fracture, aneurysm sac dynamics, and aortic rupture rates among patients treated with bell bottom limbs (BB), iliac branch endoprosthesis (IBE), and coil and cover (CC) approaches from the Global Registry for Endovascular Aortic Treatment registry. Secondary end points were all-cause mortality, stroke, reintervention, and paraplegia. METHODS: Subjects from the GORE Global Registry for Endovascular Aortic Treatment were enrolled over a 5-year period from October 2017 to August 2022. We included 924 subjects in this study. Statistical data was generated on R software and limb groups were compared using the Pearson's χ2 test and the Kruskal-Wallis rank-sum test. RESULTS: We found no statistical difference in endoleak rates, stent graft migration, fracture, or aortic rupture when stratified by limb strategy. There was no difference between limb approaches with regard to aneurysm sac dynamics among those with abdominal aortic aneurysms and common iliac aneurysms. Similarly, no statistical difference between limb strategies was found in all-cause mortality, stroke, paraplegia, or reintervention rates. Among patients that required an additional graft during reintervention, the highest rates were found within the IBE group 8.6%, compared with BB group 2.2% and CC group 1.3% (P = .006). CONCLUSIONS: Overall, there was no difference among limb strategies in endoleak rates, stent graft migration, aneurysm sac dynamics, aortic rupture rates, or our secondary end points. Increased rates of reintervention requiring an additional graft within the IBE group is noteworthy and must be weighed against the adverse effects of hypogastric sacrifice with the CC approach or potentially less advantageous seal zones in the BB approach. This finding suggests that all limb approaches have equivalent effectiveness in managing the aneurysmal common iliac artery; thus, the choice of limb strategy should be individualized and remain at physician discretion. Future research should include a more robust sample size to reproduce these findings.

Three-year outcomes of off-the-shelf Gore thoracoabdominal multibranch endoprosthesis and physician-modified endografts for complex abdominal and thoracoabdominal aortic aneurysms.

OBJECTIVE: Fenestrated-branched endovascular aortic repair (FB-EVAR) has shown favorable outcomes for repair of complex aneurysms and thoracoabdominal aortic aneurysms. Physician-modified endografting (PMEG) and the Gore thoracoabdominal multibranch endoprosthesis (TAMBE) provide custom and off-the-shelf devices for FB-EVAR, respectively. This study compares the outcomes of TAMBE and PMEG at a single institution. METHODS: A retrospective review of patients who underwent TAMBE as part of the multicenter pivotal trial or PMEG as part of a prospective physician-sponsored investigational device exemption at a single institution between 2020 and 2022 were completed. Patient demographics, characteristics, and perioperative and midterm outcomes were compared. RESULTS: A total of 68 patients were included, with 12 in the TAMBE group and 56 in the PMEG group. Baseline characteristics were comparable between groups. Aneurysm type was most often thoracoabdominal aortic aneurysm in both groups (58% TAMBE and 52% PMEG). TAMBE had a higher rate of upper extremity access (100% vs 63%; P = .013) and longer mean procedure time (247 ± 36 minutes vs 189 ± 49 minutes; P < .001). Other intraoperative metrics were similar between groups. Technical success was 100% in TAMBE and 95% in PMEG (P = .412). There was no 30-day mortality in either group. No major adverse events occurred with TAMBE, whereas in PMEG cases, 2% had respiratory failure, 2% required dialysis, and 4% experienced spinal cord ischemia. Although the overall endoleak rates were similar (50% of TAMBE vs 41% of PMEG; P = .57), type II endoleaks accounted for all of the endoleaks in the TAMBE group, whereas type I or III endoleaks were seen in 11% of PMEG patients. At a median follow-up of 26.7 months for the TAMBE group and 21.2 months for the PMEG group, target vessel instability was seen in 10.4% of TAMBE, and 6.9% of PMEG targeted branches (P = .401). Reintervention was required in 33% of TAMBE patients and 27% of PMEG patients (P = .646). Estimated freedom from reintervention rates at 3 years were similar (56% TAMBE vs 62% PMEG, log-rank P = .910). Freedom from visceral renal target vessel instability at 3 years was 89% for both groups (log-rank P = .459). The Kaplan-Meier 3-year estimated survival was 100% for patients in the TAMBE group and 77% for patients in the PMEG group (log-rank P = .157). CONCLUSIONS: At experienced centers, FB-EVAR can be completed with PMEG or TAMBE with comparable, excellent perioperative and midterm outcomes. Reinterventions are frequently needed for both TAMBE and PMEG.

Nellix Device Failure Mechanisms Analysis on Explanted Grafts.

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.

Midterm Outcomes of Patients With Complex Aortic Aneurysms Treated Using Mixed and Matched Endoprosthesis From Different Manufacturers.

OBJECTIVES: To evaluate outcomes of patients with complex aortic aneurysms (cAAs) undergoing fenestrated/branched endovascular aortic aneurysm repair (f/b-EVAR) using a combination of endoprostheses from different manufacturers. METHODS: The study is a 2-center retrospective analysis of prospectively maintained databases of patients with cAAs undergoing f/b-EVAR using a combination of endoprostheses from different manufacturers from 2013 to 2023. Primary endpoints included technical success, major adverse events and reintervention rates. Technical success was defined as implantation of the device without type I or type III endoleak or conversion to open repair. Secondary endpoints included mortality and mid-term device performance. RESULTS: During this time, 353 patients with cAAs underwent f/b-EVARs at both centers. Of these, 80 (22.7%) required use of a combination of devices from 4 different manufacturers for repair. Fifty-one (64%) were treated for thoracoabdominal aortic aneurysms and 29 (36%) for pararenal aneurysms. Majority (74%) were male with a median age of 75 (69, 81) years and aneurysm size of 65 (59, 72) mm. Thirty-five (44%) patients required a proximal thoracic stent graft-W.L. Gore (17), Cook, Medtronic, and Terumo (6), respectively. Seventy-seven (96%) patients required a bifurcated device, including Cook Flex (34), Gore (40), and Medtronic (3). Twelve patients underwent common iliac artery aneurysm repair with a Gore iliac branched endoprosthesis. One hundred fifty-four limbs were implanted: Gore: 68, Cook: 82 and Medtronic: 4. Three hundred fourteen target vessels were incorporated. Median operating room time, estimated blood loss, fluoroscopy time and dose were 209 (186, 278) minutes, 100 (50, 663) mL, 77 (59, 100) minutes, 2385 (1415, 3885) mGy, respectively. Three endoleaks were observed on completion angiography-2 type Ic and 1 type IIIa-all of which resolved at 1 month. Fifteen MAEs were observed in 11 patients at 30 days, including 3 (3.9%) deaths, 7 renal insufficiency, 1 renal failure requiring dialysis, 2 MI and paraplegia, respectively. At a median follow-up of 400 (85, 1132) days, there were 8 reinterventions for endoleaks in 7 patients. CONCLUSIONS: The use of mixed devices proximal and distal to f/b-devices built to treat patients with cAAs is safe and has good mid-term results. CLINICAL IMPACT: While not yet formally assessed in randomized clinical trials or endorsed by the Food and Drug Administration (FDA), the practice of utilizing devices from various manufacturers to address complex aortic anatomy is widespread in everyday clinical settings, yet outcomes remain insufficiently documented. To our knowledge, ours is the first manuscript demonstrating that the use of endoprostheses from different manufacturers for treating patients with complex aortic aneurysms is both safe and yields favorable mid-term results. This frequently employed strategy warrants further exploration through meticulously designed clinical trials, aiming to furnish vascular specialists with a well-founded guideline based on robust clinical evidence.

Five-Year Outcomes of the SuperB Trial: A Multicenter Randomized Controlled Trial Comparing Heparin-Bonded Endograft to Surgical Femoropopliteal Bypass.

OBJECTIVE: 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. BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSION: 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. CLINICAL IMPACT: 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.

Durability of intercalary endoprosthesis for humeral reconstruction.

INTRODUCTION: The humerus is a common site of metastases and primary tumors. For some patients with a segmental defect and/or diaphyseal cortical destruction a cemented intercalary device may provide a more reliable construct, however data on their use is limited. METHODS: We reviewed 43 (28 male and 15 female) patients treated with an intercalary humeral spacer at a single tertiary referral center between 1989 and 2022. Humeral lesions were most commonly secondary to metastatic disease (n = 29, 68%), with 25 (58%) patients presenting with a pathologic fracture. Mean age and body mass index were 66 years and 27.9 kg/m2 . First generation taper joint device were used in 22 patients and second-generation lap device in 21 patients. RESULTS: Following reconstruction the 2-year overall survival was 30%. Mechanical complications occurred in 11 patients, most commonly aseptic loosening (n = 6, 14%). With death as a competing risk, the cumulative incidence of mechanical failure was 28% at 2-years postoperative. Following the procedure, mean Musculoskeletal Tumor Society scores was 70% and mean shoulder elevation was 87°. CONCLUSION: Reconstruction of the humeral diaphysis with an intercalary endoprosthesis provides restoration of function of the upper extremity, however, is associated with one in four patients having mechanical failure.

Comparison of reconstructive techniques for nonprimary malignancies in the proximal humerus.

BACKGROUND: Endoprostheses (EPC) are often utilized for reconstruction of the proximal humerus with either hemiarthroplasty (HA) or reverse arthroplasty (RA) constructs. RA constructs have improved outcomes in patients with primary lesions, but no studies have compared techniques in metastatic disease. The aim of this study is to compare functional outcomes and complications between HA and RA constructs in patients undergoing endoprosthetic reconstruction for proximal humerus metastases. METHODS: We retrospectively reviewed our institutional arthroplasty database to identify 66 (56% male; 38 HA and 28 RA) patients with a proximal humerus reconstruction for a non-primary malignancy. The majority (88%) presented with pathologic fracture, and the most common diagnosis was renal cell carcinoma (48%). RESULTSS: Patients with RA reconstructions had better postoperative forward elevation (74° vs. 32°, p < 0.01) and higher functional outcome scores. HA patients had more complications (odds ratio 13, p < 0.01), with instability being the most common complication. CONCLUSIONS: Patients with nonprimary malignancies of the proximal humerus had improved functional outcomes and fewer complications after undergoing reconstruction with a reverse EPC compared to a HA EPC. Preference for reverse EPC should be given in patients with good prognosis and ability to complete postoperative rehabilitation.

Larger stem to bone diameter ratio predicts lower cemented endoprosthesis failure.

BACKGROUND AND OBJECTIVES: With continued advances in treatment options, patients with endoprosthetic reconstruction are living longer and consequently relying upon their devices for a longer duration. Major causes of endoprosthesis failure include aseptic loosening and mechanical failure. In the setting of tumor resection, loss of bone stock and use of radiation therapy increase the risk for these complications. As such, considerations of remaining native bone and stem length and diameter may be increasingly important. We asked the following questions: (1) What was the overall rate of endoprosthesis failure at a minimum of 5-year follow-up? (2) Does resection length increase implant failure rates? (3) Does implant size and its ratio to cortical width of bone alter implant failure rates? METHODS: We retrospectively analyzed patient outcomes at a single institution between the years of 1999-2022 who underwent cemented endoprosthetic reconstruction at the hip or knee and identified 150 patients. Of these 150, 55 had a follow-up of greater than 5 years and were used for analysis. Radiographs of these patients at time of surgery were assessed and measured for resection length, bone diameter, stem diameter, and remaining bone length. Resection percentage, and stem to bone diameter ratios were then calculated and their relationship to endoprosthesis failure were analyzed. RESULTS: Patients in this cohort had a mean age of 55.8, and mean follow-up of 59.96 months. There were 78 distal femoral replacements (52%), 16 proximal femoral replacements (10.7%), and 56 proximal tibial replacements (37.3%). There were five patients who experienced aseptic loosening and six patients who experienced mechanical failure. Patients with implant failure had a smaller mean stem to bone diameter (36% vs. 44%; p = 0.002). A stem to bone diameter of 40% appeared to be a breaking point between success and failure in this series, with 90% of patients with implant failure having a stem: bone ratio less than 40%. Stem to bone ratio less than 40% increased risk for failure versus stems that were at least 40% the diameter of bone (6/19 [31.6%] vs. 0/36 [0%]; odds ratio 0.68; p < 0.001). Resection length did not appear to have an impact on the rates of aseptic loosening and mechanical failure in this series. CONCLUSIONS: Data from this series suggests a benefit to using stems with a larger diameter when implanting cemented endoprostheses at the hip or knee. Stems which were less than 40% the diameter of bone were substantially more likely to undergo implant failure.

Burden of Candida-related vascular graft infection: a nested-case control study.

PURPOSE: We aimed to assess risk factors of candida-related Vascular Graft Infections (VGIs). METHODS: We did a case-control study (1:4) matched by age and year of infection, nested in a cohort of patient with a history of VGIs. Cases were defined by a positive culture for Candida spp. in biological samples and controls were defined by a positive culture for bacterial strains only in biological samples. Risk factors for Candida-related VGIs were investigated using multivariate logistic regression. Mortality were compared using survival analysis. RESULTS: 16 Candida-related VGIs were matched to 64 bacterial-related VGIs. The two groups were comparable regarding medical history and clinical presentation. Candida-related VGIs were associated with bacterial strains in 88% (14/16). Gas/fluid-containing collection on abdominal CT scan and the presence of an aortic endoprosthesis were risk factors for Candida spp.-related VGIs [RRa 10.43 [1.81-60.21] p = 0.009 RRa and 6.46 [1.17-35.73] p = 0.03, respectively]. Candida-related VGIs were associated with a higher mortality when compared to bacterial-related VGIs (p = 0.002). CONCLUSIONS: Candida-related VGIs are severe. Early markers of Candida spp. infection are needed to improve their outcome. The suspicion of aortic endoprosthesis infection may necessitate probabilistic treatment with antifungal agents.

Impact of Combining Iliac Branch Endoprosthesis and Physician-Modified Fenestrated-Branched Endovascular Repair for Complex Abdominal and Thoracoabdominal Aortic Aneurysms with Concomitant Iliac Artery Aneurysms.

OBJECTIVES: Treatment of iliac artery aneurysms (IAA) with the Iliac Branch Endoprosthesis (IBE) during endovascular repair of infrarenal abdominal aortic aneurysm (EVAR) has been well-documented as effective. However, limited data exists evaluating the safety and efficacy of treating complex abdominal (cAAA) and thoracoabdominal aortic aneurysms (TAAA) with associated IAA with combined physician-modified fenestrated branched endovascular aortic repair (PM-FBEVAR) and IBE. Moreover, limited studies exist assessing the impact of adding IBE on the outcomes following PM-FBEVAR. Therefore, we compared the clinical outcomes of patients who underwent PM-FBEVAR with and without IBE for the treatment of cAAA and TAAA. METHODS: A single institution retrospective review of consecutive patients who underwent PM-FBEVAR between September 2015 and February 2021 was conducted. Patients with both unilateral and bilateral IBE implantation were included. Infected aneurysms and pseudoaneurysms were excluded. Demographics, technical success, and operative factors were analyzed. Primary outcomes were incidence of pelvic ischemia including buttock and thigh claudication, bowel and spinal cord ischemia, patency of internal and external limbs of IBE, and target vessel instability. Secondary outcomes included technical success, 30-day major adverse events (MAE), 30-day and all-cause mortality, and endoleaks. RESULTS: Among 183 patients identified who underwent PM-FBEVAR, 22 patients underwent PM-FBEVAR and IBE with 3 patients treated with bilateral IBEs. There was no pelvic ischemia in the PM-FBEVAR and IBE group. Technical success, fluoroscopy time, and procedure time were comparable between the two groups. Contrast usage was higher in the PM-FBEVAR and IBE group (p=0.01). Thirty-day MAE and mortality were not statistically different between the two groups. At mean follow-up of 23 months, all-cause mortality was similar for both groups (21% vs 27%; p=0.47). Patency of internal iliac artery limb and external iliac artery limb of the IBE were 96% (24 of 25) and 100%, respectively, during mean follow-up of 23 months. The patient with occlusion of internal iliac limb was asymptomatic and received no re-intervention. CONCLUSION: Treatment of cAAA and TAAA associated with IAA using combined PM-FBEVAR and IBE is feasible with high efficacy and safety, and without adverse effect on outcomes. Long-term follow-up is planned to assess durability of repair with PM-FBEVAR and IBE.

Is 3D-printed self-stabilizing endoprosthesis reconstruction without supplemental fixation following total sacrectomy a viable approach for sacral tumours?

PURPOSE: The spinopelvic reconstruction poses significant challenges following total sacrectomy in patients with malignant or aggressive benign bone tumours encompassing the entire sacrum. In this study, we aim to assess the functional outcomes and complications of an integrated 3D-printed sacral endoprostheses featuring a self-stabilizing design, eliminating the requirement for supplemental fixation. METHODS: We retrospectively analyzed patients with sacral tumours who underwent total sacrectomy followed by reconstruction with 3D-printed self-stabilizing endoprosthesis. Clinically, we evaluated functional outcomes using the 1993 version of the musculoskeletal tumour society (MSTS-93) score. Perioperative and postoperative complications were also documented. RESULTS: 10 patients met final inclusion criteria. The median age was 49 years (range, 31-64 years). The median follow-up time was 26.5 months (range, 15-47 months). Median postoperative functional MSTS-93 was 22.5 (range, 13-25). The median operation time was 399.5 min (305-576 min), and the median intraoperative blood loss was and 3200 ml (2400-7800 ml). Complications include wound dehiscence in one patient, bowel, bladder, and sexual dysfunction in four patients, cerebrospinal fluid leak in one patient, and tumour recurrence in one patient. There were no mechanical complications related to the endoprosthesis at the last follow-up. CONCLUSION: The utilization of 3D-printed self-stabilizing endoprosthesis proved to be a viable approach, yielding satisfactory short-term outcomes in patients undergoing total sacral reconstruction without supplemental fixation.

Patency rates following treatment with the WRAPSODY™ Cell-Impermeable Endoprosthesis for recalcitrant renal access circuit dysfunction: Results from a tertiary Australian centre.

OBJECTIVE: To describe clinical outcomes associated with the use of the WRAPSODY Cell-Impermeable Endoprosthesis at a tertiary center in Western Australia. METHODS: Patients with recalcitrant occlusive disease in the venous outflow of their arteriovenous access circuits were treated with WRAPSODY. Patients were prospectively followed up to 12-month post-procedure. Study measures included 30-day adverse events, technical success, target lesion primary patency, access circuit primary patency, and assisted access circuit primary patency. RESULTS: Twenty-seven WRAPSODY devices were used to treat 15 consecutive patients. The technical success rate was 100%. No device-related adverse events were observed during the follow-up period. Two patients did not complete the full follow up. Patency rates at 3-, 6-, and 12 months for target lesion primary patency were 100% (15/15), 100% (15/15), and 100% (13/13), respectively. Rates for access circuit primary patency at 3-, 6-, and 12 months were 73.3% (11/15), 46.7 % (7/15), and 46.2% (6/13), respectively. Edge stenosis was observed in 33.3% (5/15) of cases and accounted for 5 of the 8 patients who experienced failed access circuit primary patency on angiogram. Primary assisted functional patency was 100% at 12 months. CONCLUSION: WRAPSODY can be utilized safely and has durable patency in real-world patients with complex anatomical renal access stenotic lesions. The therapeutic benefits associated with the device may encourage broader use in clinical practice.

Reverse shoulder arthroplasty megaprosthesis for surgical management of severe proximal humeral bone loss.

BACKGROUND: Shoulder arthroplasty in the setting of severe proximal humerus bone loss can be challenging. The purpose of this study was to evaluate the outcomes of a modular segmental megaprosthesis when implanted in a reverse configuration for complex primary arthroplasty, reconstruction at the time of oncologic resection, and revision shoulder arthroplasty. MATERIALS AND METHODS: A Joint Registry Database was queried to identify all shoulder arthroplasties performed at a single institution using the Comprehensive Segmental Revision System reverse shoulder arthroplasty (SRS-RSA; Zimmer Biomet). A retrospective review of electronic medical records and radiographs was performed to record demographic data, indication, outcomes, complications, and revision surgery. RESULTS: Between February 2012 and October 2022, a total of 76 consecutive SRS-RSAs were implanted. An analysis of patients with minimum 12-month follow-up yielded 53 patients with a mean follow-up of 4.1 ± 2.43 years. Surgical complication rate in this cohort was observed in 41.5% (22 of 53) of cases. Overall, the revision rate at final follow-up was 26.4% (14 of 53), with a significant difference between the primary and revision cohorts. The number of prior surgeries was a significant risk factor for revision surgery, with a hazard ratio of 1.789 (95% confidence interval 1.314-2.436, P < .001). When analyzing aseptic humeral loosening rates across study cohorts, a significant difference was found between the primary arthroplasty (0%, n = 0) and the revision arthroplasty cohorts (22.2%, n = 6) (P = .04). DISCUSSION: Reverse shoulder arthroplasty using a modular segmental megaprosthesis remains a reasonable salvage option for shoulder reconstruction in the setting of proximal humeral bone loss. Because of the substantial bone loss and soft tissue deficiencies typically present in these cases, surgeons should educate patients on the relatively high complication rate, particularly when used in the setting of a previous failed arthroplasty.

Debridement, Antibiotics, and Implant Retention (DAIR) Plus Offers Similar Periprosthetic Joint Infection Treatment Success Rates to Two-Stage Revision in Oncologic Megaprosthesis.

BACKGROUND: Prosthetic joint infections (PJIs) after megaprosthesis implantation are associated with high rates of treatment failure and amputation. Our study analyzed PJI treatment success rates by surgical strategy and assessed risks of reinfection and amputation. METHODS: We retrospectively analyzed the outcomes of patients diagnosed with PJI after undergoing megaprosthesis implantation for oncologic indications. The 2011 Musculoskeletal Infection Society criteria were used to define PJI. Reinfection, reoperation, and amputation for PJI recurrence were assessed. A total of 67 patients with megaprosthesis PJIs were included. There were fourteen patients who were treated with debridement, antibiotics, and implant retention (DAIR), 31 with DAIR plus (DAIR with modular component exchange and stem retention), and 21 with two-stage revisions. Kaplan-Meier estimates were used for survival analyses and Cox proportional hazards for risk factor analyses. RESULTS: The two-year reinfection-free survival was 25% for DAIR and 60% for DAIR plus or two-stage revision (P = .049). The five-year amputation-free survival was 84% for DAIR plus or two-stage revision, and 48% for DAIR (P = .13). Reinfection-free, reoperation-free, and amputation-free survival were similar between DAIR plus and two-stage revision at the 2- and 5-year marks. Body mass index ≥30 (hazard ratio [HR] = 2.65) and chronic kidney disease (HR = 11.53) were risk factors for reinfection. Treatment with DAIR plus or two-stage revision (HR = 0.44) was a protective factor against reinfection. CONCLUSIONS: A DAIR was associated with high rates of treatment failure and higher amputation rates than DAIR plus or 2-stage surgery. A DAIR plus was not inferior to 2-stage revision clearing a PJI and might be performed in patients who cannot withstand two-stage revision surgery.

[Ankle replacement for severe post-traumatic deformation of the distal tibia: a case report]. / Endoprotezirovanie golenostopnogo sustava pri lechenii gruboi posttravmaticheskoi deformatsii distal'nogo otdela bol'shebertsovoi kosti. Klinicheskii sluchai.

OBJECTIVE: To evaluate the immediate results of ankle replacement with original prosthesis in a patient with severe post-traumatic deformation of the distal tibia. MATERIAL AND METHODS: When developing the original design of ankle prosthesis, we considered foreign analogues of classical and revision models of ankle prostheses taking into account their shortcomings. In this case, an integrated approach was used. Extensive work has been carried out to select materials for prosthetic components. Experimental work with mesenchymal stromal cells of bone marrow was aimed at testing cytotoxicity and biological compatibility. The staff of the department of designing biomechanical structures of the Research Institute of Bionics and Personalized Medicine of the Samara State Medical University carefully studied the proposed design of endoprosthesis using the Ansys software. After cadaver tests on full-scale models, we performed surgical intervention in a patient with severe post-traumatic deformity of the lower third of the left tibia. RESULTS: Our studies revealed convenience and certain advantages of intraoperative installation of original ankle prosthesis. Along with this, this clinical example indicated come features that must be taken into account in revision ankle replacement to avoid possible postoperative consequences. CONCLUSION: Original ankle prosthesis makes it possible to replace the distal tibia and preserve limb function.

[Rehabilitative technologies in patients after total endoprosthesis of lower limbs' major joints: scientometric analysis]. / Reabilitatsionnye tekhnologii u patsientov posle total'nogo endoprotezirovaniya krupnykh sustavov nizhnikh konechnostei: naukometricheskii analiz.

Dynamically developing sphere of physical and rehabilitative medicine raises an important issue on implementation of technologies with proven effectiveness to recover neuromuscular, skeletal and movement-related functions, activity and partipation of traumatological patients into rehabilitation practice. The aim of this review is the consistent information analysis and synthesis of evidence-based researches of current effective methods in the context of medical rehabilitation after endoprosthesis of lower limbs' major joints, as well as the provision of structured information that helps to influence on decision-making for doctors of physical and rehabilitative medicine and other professionals who take part in multidisciplinary interaction.

Functional and Oncological Outcome of Patients with Distal Femoral Osteosarcoma Managed by Limb Salvage Using Modular Endoprosthesis.

BACKGROUND: The aim of the study was to assess the functional and oncological outcomes of patients with distal femoral osteosarcoma managed by limb salvage using modular endoprosthesis as well as to assess related complications. PATIENTS AND METHODS: A total of 82 patients were included in our study. Functional outcome was assessed using MSTS score and knee range of motion. Oncological outcome was assessed regarding local recurrence, chest metastasis, and patient survivorship. Complications were classified according to Henderson et al. RESULTS: The mean MSTS score was 26.21 (87.4%) (range 8-30 points) with 70.7% of patients having more than 90° of flexion. The incidence of local recurrence was 3.7% (3 patients), while the incidence of chest metastasis was 14.6% (12 patients). Aseptic loosening (type 2 failure) was the commonest complication (19.5%), followed by infection (15.9%). The 5- and 10-year survivorships of the limb were 98.8%, while the 5- and 10-year survivorships of the prosthesis were 67.7% and 52.4%, respectively. CONCLUSION: This study showed that patients with osteosarcoma distal femur who are treated by chemotherapy and limb salvage have an excellent long-term prognosis in terms of patient as well as limb survivorship. The use of modular endoprosthesis in these patients offer an acceptable function, with two-thirds of the patients retaining their prosthesis after 5 years and more than half retaining them after 10 years.

Endovascular Treatment of TASC C and D Femoropopliteal Arterial Disease With Heparin-Bonded Covered Stents: The Impact of Distal Run-Off Vessels.

INTRODUCTION: In the last 2 decades, several studies in the literature evaluated the possible role of covered stents in the treatment of TransAtlantic Inter-Society Consensus (TASC) C and D femoropopliteal lesions but, despite the encouraging results, the employment of these devices was never included in clinical guidelines. The aim of this study is to evaluate the role of the technical aspects in patients with TASC C or D lesions that were treated with the GORE VIABAHN endoprosthesis and to elaborate a computerized method to objectively estimate the post-stent run-off and predict stent-graft failure. MATERIALS AND METHODS: In this monocentric retrospective study, we collected the patients who were treated in our department from December 2014 to May 2021. Inclusion criteria comprised: (1) patients who underwent endovascular treatment of a TASC C or D femoropopliteal lesions using one or more heparin-bonded covered stent(s) and (2) clinical follow-up >2 years. Exclusion criteria were clinical follow-up <2 years or missing. An in-house computerized analysis to estimate the post-stent run-off, CEVERO (Computerized Estimation of VEssel Run-Off), was elaborated. RESULTS: Sixty-six patients were enrolled in the study. Eleven patients had a TASC type C lesion, and 55 patients presented a type D lesion. The median follow-up time was 2.6 years. Twenty-nine patients (43.9%) experienced a major adverse limb event. Primary patency after 6, 12 and 24 months was 74.2%, 60.6%, and 57.6%; primary-assisted patency was 78.8%, 65.2%, and 59.1%. The presence of <2 run-off vessels (p<0.001) was correlated with stent-graft failure. The CEVERO analysis demonstrated an accuracy of 90.0% in predicting stent-graft failure. CONCLUSIONS: The treatment of TASC C and D femoropopliteal lesions remains technically challenging. Our study supported the hypothesis that run-off is the most critical factor in determining the outcome of the procedure and that concomitant angioplasty of the tibial vessels might improve the patency of the covered stent. The CEVERO analysis could permit a real-time, objective estimation of the distal run-off using conventional angiographic images, and it might be employed as a tool in the intraprocedural decision-making process, but its clinical applicability should be evaluated on external validation cohorts. CLINICAL IMPACT: The endovascular treatment of TASC C and D femoropopliteal lesions is technically challenging and run-off seems to be the most critical factor in determining the outcome. Concurrent angioplasty of the tibial vessels can create adequate run-off to avoid stent failure. The CEVERO analysis is a computerized estimation of run-off that might be a useful tool in the decision-making process.

Techniques and Limitations of Gore Thoracoabdominal Multibranch Endoprosthesis (TAMBE) for Type 1A Endoleak After Failed Endovascular Aortic Repairs.

PURPOSE: Endovascular aortic aneurysm repair (EVAR) is the dominant treatment modality over open repair for abdominal aortic aneurysms. However, a higher rate of reinterventions remains the Achilles heel of EVAR. Although type 1A endoleak from proximal seal zone failure of EVAR remains one of the leading causes for reintervention, fenestrated branched devices suitable for proximal extension of failed EVAR are not widely available in the United States. Gore Thoracoabdominal Multibranch Endoprosthesis (TAMBE) is an off-the-shelf investigational device that provides supraceliac seal by incorporating 4 visceral and renal arteries via preloaded inner branches. CASE REPORT: In this article, we describe 2 cases of type 1A endoleak from previous EVAR devices repaired using TAMBE. Both cases were performed under the Food and Drug Administration (FDA) compassionate use exemption. Considerations on the case planning and implantation techniques of TAMBE specific to previous EVAR devices are reviewed. CONCLUSIONS: Gore TAMBE can be utilized to repair a type 1A endoleak of a previous infrarenal EVAR device. Greater supraceliac coverage necessary for TAMBE relative to the minimal seal zone should be considered when applying this device for a type 1A endoleak. CLINICAL IMPACT: This report demonstrates the feasibility of applying off-the-shelf TAMBE device to treat one of the most common failure modes of EVAR, type1A endoleak.