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1.
Ann Vasc Surg ; 79: 273-278, 2022 Feb.
Article in English | MEDLINE | ID: mdl-34644640

ABSTRACT

OBJECTIVES: Low profile endovascular aneurysm repair (EVAR) devices such as the Cordis INCRAFT AAA Stent Graft System may expand the category of patients suitable for endovascular repair. We report our experience with the INCRAFT system in treating ruptured abdominal aortic aneurysms (rAAA). METHODS: We included all patients presenting with rAAA from 2015 to 2019 in our hospital who were treated by percutaneous EVAR with the INCRAFT system. The primary outcome was technical success, referring to adequate stent graft placement. Secondary outcomes included completion of the procedure under local anesthesia and mortality at 30-days, one year and long-term follow-up. RESULTS: Fifteen male patients (mean age: 74 years, SD 6.7) were treated for rAAA with a median aneurysm diameter of 8.25 cm (SD 1.66). The device was successfully delivered and deployed in all subjects. Per-procedurally one type I endoleak required additional stent placement and one patient developed an acute thrombosis of the device main body and iliac limbs requiring thrombectomy. 80.0% of patients were successfully treated under local anesthesia only. The 30 day and one year mortality were 26.6% and 33.3% respectively. Long-term survival was 60.0% at a median follow-up period of 57 months, with two patients requiring late reintervention for an endoleak. CONCLUSIONS: The INCRAFT system can be used to percutaneously treat rAAA with a high technical success rate and mortality similar to reported in the literature for other devices. The large majority of procedures can be completed with only local anesthesia.


Subject(s)
Aortic Aneurysm, Abdominal/surgery , Aortic Rupture/surgery , Blood Vessel Prosthesis Implantation/instrumentation , Blood Vessel Prosthesis , Endovascular Procedures/instrumentation , Stents , Aged , Aged, 80 and over , Anesthesia, Local , Aortic Aneurysm, Abdominal/diagnostic imaging , Aortic Rupture/diagnostic imaging , Blood Vessel Prosthesis Implantation/adverse effects , Endovascular Procedures/adverse effects , Humans , Male , Middle Aged , Postoperative Complications/etiology , Prosthesis Design , Retrospective Studies , Time Factors , Treatment Outcome
2.
Ann Vasc Surg ; 71: 392-401, 2021 Feb.
Article in English | MEDLINE | ID: mdl-32827677

ABSTRACT

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.


Subject(s)
Aortic Aneurysm, Abdominal/surgery , Aortic Dissection/surgery , Aortic Rupture/surgery , Blood Vessel Prosthesis Implantation/instrumentation , Blood Vessel Prosthesis , Endovascular Procedures/instrumentation , Iliac Aneurysm/surgery , Stents , Aged , Aged, 80 and over , Aortic Dissection/diagnostic imaging , Aortic Aneurysm, Abdominal/diagnostic imaging , Aortic Rupture/diagnostic imaging , Blood Vessel Prosthesis Implantation/adverse effects , Endovascular Procedures/adverse effects , Female , Humans , Iliac Aneurysm/diagnostic imaging , Length of Stay , Male , Middle Aged , Operative Time , Postoperative Complications/therapy , Retreatment , Retrospective Studies , Time Factors , Treatment Outcome
3.
J Vasc Surg ; 73(3): 856-866, 2021 03.
Article in English | MEDLINE | ID: mdl-32623106

ABSTRACT

BACKGROUND: Endologix issued important safety updates for the AFX Endovascular AAA System in 2016 and 2018 owing to the risk of type III endoleaks. Outcomes with these devices are limited to small case series with short-term follow-up. We describe the midterm outcomes for a large cohort of patients who received an Endologix AFX or AFX2 device. STUDY DESIGN: Data from an integrated healthcare system's implant registry, which prospectively monitors all patients after endovascular aortic repair, was used for this descriptive study. Patients undergoing endovascular aortic repair with three AFX System variations (Strata [AFX-S], Duraply [AFX-D], and AFX2 with Duraply [AFX2]) were identified (2011-2017). Crude cumulative event probabilities for endoleak (types I and III), major reintervention, conversion to open, rupture, and mortality (aneurysm related and all cause) were estimated. RESULTS: Among 605 patients, 375 received AFX-S, 197 received AFX-D, and 33 received AFX2. Median follow-up for the cohort was 3.9 (interquartile range, 2.5-5.1) years. The crude 2-year incidence of overall endoleak, any subsequent reintervention or conversion, and mortality was 8.8% (95% confidence interval [CI], 6.3-12.3), 12.0% (95% CI, 9.1-15.9), and 8.8% (95% CI, 6.3-12.2) for AFX-S. Respective estimates for AFX-D were 7.9% (95% CI, 4.8-13.0), 10.6% (95% CI, 6.9-16.1), and 9.7% (95% CI, 6.3-14.7); for AFX2, they were 14.1% (95% CI, 4.7-38.2), 16.2% (95% CI, 6.4-37.7), and 21.2% (95% CI, 10.7-39.4). CONCLUSIONS: The midterm outcomes of a large U.S. patient cohort with an Endologix AFX or AFX2 System demonstrate a concerning rate of adverse postoperative events. Patients with these devices should receive close clinical surveillance to prevent device-related adverse events.


Subject(s)
Aortic Aneurysm/surgery , Blood Vessel Prosthesis Implantation/instrumentation , Blood Vessel Prosthesis , Delivery of Health Care, Integrated , Endovascular Procedures/instrumentation , Aged , Aged, 80 and over , Aortic Aneurysm/diagnostic imaging , Aortic Aneurysm/mortality , Aortic Rupture/etiology , Aortic Rupture/mortality , Aortic Rupture/therapy , Blood Vessel Prosthesis Implantation/adverse effects , Blood Vessel Prosthesis Implantation/mortality , Endoleak/etiology , Endoleak/mortality , Endoleak/therapy , Endovascular Procedures/adverse effects , Endovascular Procedures/mortality , Female , Humans , Male , Prosthesis Design , Registries , Retreatment , Retrospective Studies , Risk Assessment , Risk Factors , Time Factors , Treatment Outcome , United States
4.
J Vasc Surg ; 73(2): 581-587, 2021 02.
Article in English | MEDLINE | ID: mdl-32473345

ABSTRACT

OBJECTIVE: Immediate-access arteriovenous grafts (IAAVGs), or early cannulation arteriovenous grafts (AVGs), are more expensive than standard grafts (sAVGs) but can be used immediately after placement, reducing the need for a tunneled dialysis catheter (TDC). We hypothesized that a decrease in TDC-related complications would make IAAVGs a cost-effective alternative to sAVGs. METHODS: We constructed a Markov state-transition model in which patients initially received either an IAAVG or an sAVG and a TDC until graft usability; patients were followed through multiple subsequent access procedures for a 60-month time horizon. The model simulated mortality and typical graft- and TDC-related complications, with parameter estimates including probabilities, costs, and utilities derived from previous literature. A key parameter was median time to TDC removal after graft placement, which was studied under both real-world (7 days for IAAVG and 70 days for sAVG) and ideal (no TDC placed with IAAVG and 1 month for sAVG) conditions. Costs were based on current Medicare reimbursement rates and reflect a payer perspective. Both microsimulation (10,000 trials) and probabilistic sensitivity analysis (10,000 samples) were performed. The willingness-to-pay threshold was set at $100,000 per quality-adjusted life-year (QALY). RESULTS: IAAVG placement is a dominant strategy under both real-world ($1201.16 less expensive and 0.03 QALY more effective) and ideal ($1457.97 less expensive and 0.03 QALY more effective) conditions. Under real-world parameters, the result was most sensitive to the time to TDC removal; IAAVGs are cost-effective if a TDC is maintained for ≥23 days after sAVG placement. The mean catheter time was lower with IAAVG (3.9 vs 8.7 months; P < .0001), as was the mean number of access-related infections (0.55 vs 0.74; P < .0001). Median survival in the model was 29 months. Overall mortality was similar between groups (76.3% vs 76.7% at 5 years; P = .33), but access-related mortality trended toward improvement with IAAVG (6.1% vs 6.8% at 5 years; P = .052). CONCLUSIONS: The Markov decision analysis model supported our hypothesis that IAAVGs come with added initial cost but are ultimately cost-saving and more effective. This apparent benefit is due to our prediction that a decreased number of catheter days per patient would lead to a decreased number of access-related infections.


Subject(s)
Arteriovenous Shunt, Surgical/economics , Blood Vessel Prosthesis Implantation/economics , Blood Vessel Prosthesis/economics , Health Care Costs , Renal Dialysis/economics , Arteriovenous Shunt, Surgical/adverse effects , Arteriovenous Shunt, Surgical/instrumentation , Arteriovenous Shunt, Surgical/mortality , Blood Vessel Prosthesis Implantation/adverse effects , Blood Vessel Prosthesis Implantation/instrumentation , Blood Vessel Prosthesis Implantation/mortality , Catheterization/economics , Clinical Decision-Making , Cost-Benefit Analysis , Decision Support Techniques , Humans , Markov Chains , Models, Economic , Prosthesis Design , Quality-Adjusted Life Years , Renal Dialysis/adverse effects , Renal Dialysis/mortality , Time Factors , Treatment Outcome
5.
J Vasc Surg Venous Lymphat Disord ; 8(1): 89-94, 2020 01.
Article in English | MEDLINE | ID: mdl-31653533

ABSTRACT

OBJECTIVE: Surgical desobliteration or endophlebectomy of the common femoral vein during deep venous recanalization with complementary polytetrafluoroethylene (PTFE) arteriovenous fistula (AVF), may lead to higher rates of surgical site infection (SSI). It has been reported that closed incisional negative pressure wound therapy (cINPT) may decrease SSI rates after different surgical procedures. The aim of this study was to determine the potential effect of cINPT on the SSI rate of femoral endophlebectomy with a complimentary PTFE AVF. METHODS: Patients with recanalization of the femoral-iliac veins and femoral endophlebectomy with a complementary PTFE AVF and postoperative cINPT were identified. SSI, patency, and complication rates were analyzed. RESULTS: This study included 65 patients with a mean age of 41 ± 14 years. The mean procedure time was 240 ± 11.9 minutes. Primary patency rate was 69.2% and secondary patency rate was 78.4%. SSI classified as Szilagyi I, II, and III occurred in 7.6% (n = 5), 3% (n = 2), and 7.6% (n = 5), respectively, with an overall SSI rate of 18.2%. Surgical wound revision with the application of a vacuum pump was required in 10.7% (n = 7). A multivariate analysis showed that the duration of the surgical procedure (P = .003) as well as lymphatic fistulas (P = .044) to have a significant impact on the SSI rate. CONCLUSIONS: Endophlebectomy with complementary PTFE AVF of the femoral vein is related to an increased rate of lymphatic leakage and SSI. Lymphatic fistula and the duration of surgery could be assessed as relevant influencing factors of SSI. Application of cINPT in this surgical setting may reduce the SSI rate. Despite this potential improvement, SSI rates still limit the clinical success of a deep venous recanalization.


Subject(s)
Arteriovenous Shunt, Surgical/instrumentation , Blood Vessel Prosthesis Implantation/instrumentation , Blood Vessel Prosthesis , Femoral Vein/surgery , Negative-Pressure Wound Therapy , Polytetrafluoroethylene , Surgical Wound Infection/prevention & control , Adult , Arteriovenous Shunt, Surgical/adverse effects , Blood Vessel Prosthesis Implantation/adverse effects , Female , Femoral Vein/diagnostic imaging , Femoral Vein/physiopathology , Germany , Humans , Male , Middle Aged , Negative-Pressure Wound Therapy/adverse effects , Prosthesis Design , Protective Factors , Retrospective Studies , Risk Assessment , Risk Factors , Surgical Wound Infection/diagnosis , Surgical Wound Infection/microbiology , Time Factors , Treatment Outcome , Vascular Patency
7.
Ann Vasc Surg ; 55: 78-84, 2019 Feb.
Article in English | MEDLINE | ID: mdl-30099168

ABSTRACT

BACKGROUND: Optimal antithrombotic therapy after lower limb infrainguinal revascularization remains a controversial topic. The use of anticoagulants, alone or in combination with antiplatelet drugs, can potentially improve patency rate and limb salvage, particularly in patients with risk factors for early thrombosis. Bleeding is the main complication of long-term anticoagulant use. New oral anticoagulants can represent an attractive alternative to the standard vitamin K antagonists. The objective of the study is to evaluate the effectiveness (bypass occlusion and major amputation) and safety (major bleeding and all-cause mortality) of rivaroxaban compared to acenocumarol after infrainguinal lower limb surgical revascularization. MATERIAL AND METHODS: Retrospective cohort study of patients with peripheral arterial disease submitted to lower limb infrainguinal bypass revascularization with vein or expanded polytetrafluoroethylene conduit, who were anticoagulated with acenocumarol or rivaroxaban after hospital discharge. Patients with proximal revascularization, revascularization due to any pathology other than peripheral arterial disease, coagulation disorder, stroke or acute myocardial infarction in less than 30 days, glomerular filtration rate <15 mL/min, or on hemodialysis were excluded. RESULTS: One hundred nine patients were included (78.9% male), with a mean age of 64.8 years. After hospital discharge, 40 patients (36.7%) were medicated with rivaroxaban and 69 patients (63.3%) with acenocumarol. At 1 year of follow-up, patients under rivaroxaban and acenocumarol presented comparable major amputation rates (12.5 % vs. 10.1%, P = 0.756), bypass occlusion (22.5% vs. 24.6 %, P = 0.769), and mortality rate (10% vs. 8.7%, P = 0.756). Major bleeding occurred in 13.8% of patients. Patients with renal dysfunction had significantly higher bleeding risk with acenocumarol (45.5% vs. 0%, P = 0.028) compared to rivaroxaban, while patients with normal renal function presented similar bleeding rates with both anticoagulants (6.1% vs. 6.4%, P = 0.953). CONCLUSIONS: Rivaroxaban has equivalent effectiveness to acenocumarol after infrainguinal bypass revascularization, with similar occlusion, major amputation, and mortality rates. Rivaroxaban has an improved safety profile in patients with moderate renal dysfunction due to a significantly lower incidence of major bleeding. In patients with normal renal function, rivaroxaban and acenocumarol present equivalent major bleeding rates.


Subject(s)
Acenocoumarol/therapeutic use , Anticoagulants/therapeutic use , Blood Vessel Prosthesis Implantation , Factor Xa Inhibitors/therapeutic use , Lower Extremity/blood supply , Peripheral Arterial Disease/surgery , Rivaroxaban/therapeutic use , Veins/transplantation , Acenocoumarol/adverse effects , Adult , Aged , Aged, 80 and over , Amputation, Surgical , Anticoagulants/adverse effects , Blood Vessel Prosthesis , Blood Vessel Prosthesis Implantation/adverse effects , Blood Vessel Prosthesis Implantation/instrumentation , Blood Vessel Prosthesis Implantation/mortality , Comorbidity , Factor Xa Inhibitors/adverse effects , Female , Hemorrhage/chemically induced , Humans , Limb Salvage , Male , Middle Aged , Peripheral Arterial Disease/diagnosis , Peripheral Arterial Disease/mortality , Peripheral Arterial Disease/physiopathology , Polytetrafluoroethylene , Prosthesis Design , Retrospective Studies , Risk Factors , Rivaroxaban/adverse effects , Time Factors , Treatment Outcome
8.
J Vasc Surg ; 69(6): 1726-1735, 2019 06.
Article in English | MEDLINE | ID: mdl-30578071

ABSTRACT

OBJECTIVE: The aim of this study was to analyze the penetration depth, angles, distribution, and location of deployment of individual EndoAnchor (Medtronic Vascular, Santa Rosa, Calif) implants. METHODS: Eighty-six primary and revision arm patients (procedural success, 53; persistent type IA endoleak, 33) treated for type IA endoleaks with a total of 580 EndoAnchor implants from a subset of the Aneurysm Treatment Using the Heli-FX Aortic Securement System Global Registry (ANCHOR) were included in this study. Procedural success was defined as the absence of a type IA endoleak on the first postprocedural computed tomography scan after the EndoAnchor implantation procedure. Endograft malapposition along the circumference was assessed at the first postoperative computed tomography scans and expressed as clock-face range and width in degrees and normalized such that the center was translated to 0 degrees. The position and penetration of each EndoAnchor implant were measured as the clock-face orientation. EndoAnchor implant penetration into the aortic wall was categorized as follows: good penetration, ≥2 mm; borderline penetration, <2 mm or ≥2-mm gap between the endograft and aortic wall; or no penetration. The orthogonal and longitudinal angles between the EndoAnchor implant and the interface plane of the aortic wall were determined. Location of deployment was investigated for each EndoAnchor implant and classified as maldeployed when it was above the fabric or in a gap >2 mm between the endograft and aortic wall due to >2-mm thrombus or positioning of the EndoAnchor implant below the aortic neck. RESULTS: A total of 170 (29%) EndoAnchor implants had maldeployment and were therefore beyond recommended use and not useful. After EndoAnchor implantation, the procedural success and persistent type IA endoleak groups had 3 (1%) and 4 (2%) EndoAnchor implants positioned above the fabric as well as 60 (18%) and 103 (42%) placed in a gap >2 mm, respectively. The amount of EndoAnchor implants with good, borderline, and no penetration was significantly different between both groups (success vs type IA endoleak) after exclusion of maldeployed EndoAnchor implants (235 [87.4%], 14 [5.2%], and 20 [7.4%] vs 97 [68.8%], 18 [12.8%], and 26 [18.4%], respectively; P < .001). Good penetration EndoAnchor implants were more closely aligned with a 90-degree orthogonal angle than the borderline penetration and nonpenetrating EndoAnchor implants. The longitudinal angle was more distributed, which was observed through all three penetration groups. CONCLUSIONS: In this subcohort of ANCHOR patients, almost 30% of the EndoAnchor implants had maldeployment, which may be prevented by careful preoperative planning and measured intraoperative deployment. If endoleaks are due to >2-mm gaps, EndoAnchor implants alone may not provide the intended sealing, and additional devices should be considered.


Subject(s)
Aortic Aneurysm, Abdominal/surgery , Blood Vessel Prosthesis Implantation/instrumentation , Blood Vessel Prosthesis , Endoleak/surgery , Endovascular Procedures/instrumentation , Foreign-Body Migration/surgery , Stents , Aortic Aneurysm, Abdominal/diagnostic imaging , Blood Vessel Prosthesis Implantation/adverse effects , Endoleak/diagnostic imaging , Endoleak/etiology , Endovascular Procedures/adverse effects , Female , Foreign-Body Migration/diagnostic imaging , Foreign-Body Migration/etiology , Humans , Male , Prosthesis Design , Registries , Reoperation , Retrospective Studies , Risk Factors , Treatment Outcome
9.
Curr Hypertens Rep ; 20(5): 46, 2018 05 09.
Article in English | MEDLINE | ID: mdl-29744599

ABSTRACT

PURPOSE OF REVIEW: Most hypertension devices have been designed to interrupt or modify the sympathetic nervous system, which seems to be unbalanced in hypertension. Carotid baroreceptors play a pivotal role in maintaining adrenergic balance via a direct feedback interface and would be an exceptional target for intervention. The purpose of this review is to define the role of the baroreceptor in hypertension, to examine device-based therapies targeting the baroreflex and to explore future promises of endovascular baroreflex amplification (EBA). RECENT FINDINGS: In the last two decades, two therapeutic strategies targeting the carotid baroreceptor have evolved: baroreflex activation therapy (BAT) and EBA. Both therapies enhance baroreceptor activity, either directly by electrical stimulation or indirectly by changing the geometric shape of the carotid sinus and increasing pulsatile wall strain. By showing a significant, sympathetic inhibition-mediated effect on blood pressure, BAT has laid the foundation for baroreflex-targeting therapies for resistant hypertension. EBA is a less invasive therapy with promising first-in-man study results. Ongoing randomized sham-controlled trials are needed to better understand efficacy, durability, and long-term safety and define phenotypes that may most benefit from this treatment.


Subject(s)
Baroreflex/physiology , Blood Pressure/physiology , Blood Vessel Prosthesis Implantation , Electric Stimulation Therapy , Hypertension/therapy , Pressoreceptors/physiopathology , Blood Vessel Prosthesis Implantation/instrumentation , Carotid Sinus/physiopathology , Computer Simulation , Humans , Hypertension/physiopathology , Stents , Sympathetic Nervous System/physiopathology
10.
J Vasc Surg ; 68(4): 1007-1016, 2018 10.
Article in English | MEDLINE | ID: mdl-29691099

ABSTRACT

OBJECTIVE: This study sought to quantify EndoAnchor (Medtronic Vascular, Santa Rosa, Calif) penetration into the aortic wall in patients undergoing endovascular abdominal aortic aneurysm repair and to assess predictors of successful penetration and its relationship to postprocedural type IA endoleak. METHODS: A subset of patients from the Aneurysm Treatment Using the Heli-FX Aortic Securement System Global Registry (ANCHOR) were included if they met the following criteria: the indication for EndoAnchor use was to treat a type IA endoleak, and postprocedure contrast-enhanced computed tomography (CT) scans of sufficient quality were available for core laboratory review. Patients undergoing implantation of cuffs or stents during the EndoAnchor implantation procedure were excluded. Baseline anatomic characteristics were recorded. The cohort was divided into patients with and without persistent type IA endoleaks at the first postoperative CT scan. Penetration of each EndoAnchor measured on this CT scan was defined as good penetration when the EndoAnchor penetrated ≥2 mm into the aortic wall, borderline penetration when EndoAnchor penetration was <2 mm or a gap remained between the endograft and aortic wall, or no penetration when the EndoAnchor did not penetrate into the aortic wall. Differences between the groups were analyzed with the Mann-Whitney U test or Fisher exact test. Multivariate analyses were performed to identify independent predictors of EndoAnchor penetration, and procedural success was defined by absence of type IA endoleak. RESULTS: Eighty-six patients of the primary (n = 61 [71%]) and revision (n = 25 [29%]) arms of the ANCHOR registry were included. There were 53 (62%) without and 33 (38%) with persistent type IA endoleaks on the first postprocedural CT scan. The median number of EndoAnchors with good penetration was significantly greater in the cohort without endoleaks, 4 (interquartile range, 3-5) vs 3 (interquartile range, 1.5-4), respectively (P = .002). A multivariate model for EndoAnchor penetration identified use of a Medtronic Endurant endograft as a factor associated with good penetration (P = .001), whereas poor penetration was associated with a larger aortic neck diameter 10 mm distal to the lowest renal artery (P < .001) and greater proximal neck calcium thickness (P = .004). EndoAnchor penetration was the only variable that attained significance (P < .001) in the multivariate model for successful treatment of a type IA endoleak. CONCLUSIONS: Adequate EndoAnchor penetration into the aortic wall is less likely when the aortic neck diameter is large or when the neck contains significant mural calcium. No penetration of the EndoAnchor was the only factor predictive of postprocedural type IA endoleak. This study stresses the importance of careful selection of patients based on preoperative assessment of the infrarenal neck on CT angiography and emphasizes careful deployment of EndoAnchors into the aortic wall to improve successful treatment of type IA endoleaks.


Subject(s)
Aortic Aneurysm, Abdominal/surgery , Blood Vessel Prosthesis Implantation/instrumentation , Endovascular Procedures/instrumentation , Suture Anchors , Aortic Aneurysm, Abdominal/diagnostic imaging , Aortography/methods , Blood Vessel Prosthesis , Blood Vessel Prosthesis Implantation/adverse effects , Computed Tomography Angiography , Endoleak/diagnostic imaging , Endoleak/etiology , Endovascular Procedures/adverse effects , Female , Foreign-Body Migration/diagnostic imaging , Foreign-Body Migration/etiology , Humans , Logistic Models , Male , Multivariate Analysis , Prosthesis Design , Registries , Retrospective Studies , Risk Factors , Treatment Outcome
11.
Ann Vasc Surg ; 47: 282.e7-282.e11, 2018 Feb.
Article in English | MEDLINE | ID: mdl-28947215

ABSTRACT

BACKGROUND: Aortic rupture in Behcet's disease is associated with high mortality rates. Endovascular approach with parallel graft technique can be a valid solution in emergency setting for the treatment of thoraco-abdominal aorta involvement in Behcet's disease. METHODS: We describe the clinical case of a 41-year-old man, urgently hospitalized for a rupture of thoraco-abdominal aorta with occlusion of the celiac trunk and involvement of superior mesenteric artery. The patient also presented a massive right hemothorax and a massive left pulmonary thromboembolism. An aortic endoprosthesis was deployed from the third bottom of the thoracic aorta to the origin of the renal arteries. Parallel stent-graft technique was used to preserve the patency of the superior mesenteric artery. The procedure was performed with local anaesthesia due to the critical conditions of the patient. The patient was discharged in good clinical conditions. RESULTS: The angio-computed tomography performed 6 months after surgery showed good deployment of the endoprosthesis and patency of the superior mesenteric artery. CONCLUSION: In high risk for surgery patients, endovascular treatment with parallel stent graft of thoraco-abdominal aorta rupture is safe and feasible.


Subject(s)
Aortic Aneurysm, Thoracic/surgery , Aortic Rupture/surgery , Behcet Syndrome/complications , Blood Vessel Prosthesis Implantation , Endovascular Procedures , Adult , Anesthesia, Local , Aortic Aneurysm, Thoracic/diagnostic imaging , Aortic Aneurysm, Thoracic/etiology , Aortic Rupture/diagnostic imaging , Aortic Rupture/etiology , Aortography/methods , Behcet Syndrome/diagnosis , Blood Vessel Prosthesis , Blood Vessel Prosthesis Implantation/instrumentation , Computed Tomography Angiography , Emergencies , Endovascular Procedures/instrumentation , Humans , Male , Pulmonary Embolism/etiology , Stents , Treatment Outcome
12.
J Vasc Surg ; 66(4): 1285-1289, 2017 10.
Article in English | MEDLINE | ID: mdl-28705593

ABSTRACT

A total of 576 patients underwent endovascular aneurysm repair using main body devices for treatment of abdominal aortic aneurysms or iliac artery aneurysms. During follow-up, type IIIb endoleaks caused by fabric tear occurred in six patients (1.0% [6/576]). The device used was Zenith (Cook Medical, Bloomington, Ind) in five cases and Talent (Medtronic, Santa Rosa, Calif) in one case. All endoleaks were close to the flow divider of the main body devices. The distance between the lower renal artery and the top end of the contralateral leg was 53 ± 14 mm. Bell-bottom-shaped Excluder (W. L. Gore & Associates, Flagstaff, Ariz) legs were placed parallel from the top of the main body device through both legs to treat these endoleaks. In two patients, coil embolization was required to treat gutter endoleaks. Postoperative computed tomography showed the obliteration of type IIIb endoleaks in all patients. Our technique may be an acceptable method for treatment of type IIIb endoleaks, especially when they occur near the flow divider.


Subject(s)
Aortic Aneurysm, Abdominal/surgery , Blood Vessel Prosthesis Implantation/instrumentation , Blood Vessel Prosthesis , Endoleak/surgery , Endovascular Procedures/instrumentation , Iliac Aneurysm/surgery , Prosthesis Failure , Aged , Aged, 80 and over , Aortic Aneurysm, Abdominal/diagnostic imaging , Aortography/methods , Blood Vessel Prosthesis Implantation/adverse effects , Computed Tomography Angiography , Echocardiography, Doppler, Color , Embolization, Therapeutic , Endoleak/diagnostic imaging , Endoleak/etiology , Endovascular Procedures/adverse effects , Humans , Iliac Aneurysm/diagnostic imaging , Male , Prosthesis Design , Treatment Outcome
13.
J Vasc Surg ; 66(1): 130-142.e1, 2017 07.
Article in English | MEDLINE | ID: mdl-28400218

ABSTRACT

OBJECTIVE: The objective of this study was to assess 1-year safety, efficacy, and invasiveness outcomes of endovascular stent grafting of symptomatic long lesions (≥10 cm) in the superficial femoral artery (SFA) as a substitute for above-knee open bypass surgery. METHODS: This prospective, multicenter (15 hospitals) study assessed heparin-coated stent grafts for the treatment of long SFA lesions in Japanese subjects with peripheral arterial disease. Inclusion criteria were Rutherford category 2 to 5 symptoms (grade 5 without active infection), ankle-brachial index ≤0.9, and color flow duplex ultrasound-assessed SFA lesions with cumulative length ≥10 cm and ≥50% stenosis. Main efficacy and safety outcomes were primary assisted patency and adverse events, respectively. Secondary outcomes included primary patency using the surgical bypass definition, that is, blood flow through a device without requiring target lesion revascularization (TLR) to maintain or to restore flow. For comparison with prior endovascular studies, primary patency-interventional was defined as peak systolic velocity ratio <2.5 without TLR in treated lesions. Other outcomes included freedom from TLR and Vascular Quality of Life questionnaire scoring. General anesthesia avoidance and hospitalization duration were compared with historical data from 68 consecutive patients (n = 51 Rutherford 2/3 claudicants and 17 Rutherford 4/5 subjects) who underwent above-knee bypass surgery at study sites between 2002 and 2012 and met study enrollment criteria. RESULTS: Of 103 enrollees (74.2 ± 7.0 years old; 17.5% female; 97.1% claudicants), 100 subjects were evaluated through postoperative 12 months. Average lesion length was 21.8 ± 5.8 cm, and 65.7% were totally occluded. The whole-cohort Kaplan-Meier estimated primary assisted patency rate was 94.1% (95% confidence interval [CI], 87.3%-97.3%) at 12 months. The primary patency-surgical rate was 92.1% (95% CI, 84.8%-96.0%), the primary patency-interventional rate was 88.1% (95% CI, 80.0%-93.1%), and freedom from TLR was 93.1% (95% CI, 86.1%-96.7%). Mean ankle-brachial index increased from 0.64 ± 0.12 to 0.98 ± 0.12 at 1 month after intervention and 0.94 ± 0 .17 at 12 months (P < .0001 at both follow-ups). Target vessel revascularization, major amputation, or death did not occur through postoperative 30 days. No life- or limb-threatening intraoperative or perioperative adverse events and no acute limb ischemia cases were observed during follow-up. Vascular Quality of Life questionnaire score increased from 58.6% ± 15.7% to 72.9% ± 18.6% at 12 months (P < .0001). No stent fractures were detected. No stent graft participant required general anesthesia, and median postoperative hospital stay was 2.0 days (mean, 3.4 ± 2.9 days) in the Viabahn (W. L. Gore & Associates, Flagstaff, Ariz) claudicant subgroup, values that were significantly lower than the 76.5% general anesthesia rate (P < .0001) and 11.0 days median hospitalization stay (mean, 12.7 ± 5.3 days; P < .0001) in the 51 open bypass claudicant subjects. CONCLUSIONS: Stent grafting appears to be a safe and less invasive alternative to above-knee bypass surgery, providing 88% to 92% primary patency at 12 months in long, complex lesions.


Subject(s)
Blood Vessel Prosthesis Implantation/instrumentation , Blood Vessel Prosthesis , Endovascular Procedures/instrumentation , Femoral Artery/surgery , Intermittent Claudication/surgery , Peripheral Arterial Disease/surgery , Stents , Aged , Aged, 80 and over , Ankle Brachial Index , Blood Vessel Prosthesis Implantation/adverse effects , Disease-Free Survival , Endovascular Procedures/adverse effects , Female , Femoral Artery/diagnostic imaging , Femoral Artery/physiopathology , Humans , Intermittent Claudication/diagnostic imaging , Intermittent Claudication/physiopathology , Japan , Kaplan-Meier Estimate , Male , Middle Aged , Peripheral Arterial Disease/diagnostic imaging , Peripheral Arterial Disease/physiopathology , Prospective Studies , Prosthesis Design , Quality of Life , Regional Blood Flow , Risk Factors , Surveys and Questionnaires , Time Factors , Treatment Outcome , Ultrasonography, Doppler, Color , Vascular Patency
14.
Tex Heart Inst J ; 43(5): 453-457, 2016 Oct.
Article in English | MEDLINE | ID: mdl-27777535

ABSTRACT

A 62-year-old man presented with fever, abdominal pain, and malaise 13 months after emergency endovascular aortic repair. Computed tomographic angiograms showed a periprosthetic fluid and gas collection, so infection was diagnosed. Open conversion was performed, involving endograft explantation and in situ aortic reconstruction. Cultures and the explanted prosthesis were positive for carbapenemase-producing Klebsiella pneumoniae, resistant to colistin. Because of the sparse data on endograft infections caused by this pathogen, we placed the patient on an empiric double-carbapenem regimen for 4 weeks. Symptomatic recovery occurred after 21 days. On the 30th day, we deployed a stent to treat a new pseudoaneurysm. Three years later, the patient had no signs of persistent or recurrent infection. We think that this is the first report of aortic endograft infection caused by colistin-resistant, carbapenemase-producing K. pneumoniae.


Subject(s)
Anti-Bacterial Agents/therapeutic use , Aortic Aneurysm, Abdominal/surgery , Bacterial Proteins/metabolism , Blood Vessel Prosthesis Implantation/adverse effects , Blood Vessel Prosthesis/adverse effects , Carbapenems/therapeutic use , Colistin , Device Removal , Drug Resistance, Bacterial , Endovascular Procedures/adverse effects , Klebsiella Infections/surgery , Klebsiella pneumoniae/drug effects , Prosthesis-Related Infections/surgery , beta-Lactamases/metabolism , Aortic Aneurysm, Abdominal/diagnostic imaging , Aortography/methods , Blood Vessel Prosthesis Implantation/instrumentation , Computed Tomography Angiography , Endovascular Procedures/instrumentation , Humans , Klebsiella Infections/diagnostic imaging , Klebsiella Infections/microbiology , Klebsiella pneumoniae/enzymology , Klebsiella pneumoniae/isolation & purification , Male , Microbial Sensitivity Tests , Middle Aged , Prosthesis-Related Infections/diagnostic imaging , Prosthesis-Related Infections/microbiology , Treatment Outcome
15.
Eur J Vasc Endovasc Surg ; 52(5): 682-688, 2016 Nov.
Article in English | MEDLINE | ID: mdl-27592733

ABSTRACT

OBJECTIVE/BACKGROUND: Pseudoaneurysm formation occurs in 2-10% of hemodialysis arteriovenous grafts (AVGs). Surgical repair often requires pseudoaneurysm resection, interposition graft placement, and insertion of a catheter as a bridge. Endovascular stent graft repair is a controversial alternative therapy. This study was performed to examine the effectiveness and mid-term outcomes of stent graft repair for AVG pseudoaneurysms. METHODS: All patients who had undergone stent graft repair for AVG pseudoaneurysms between December 2012 and July 2015 were identified from hospital medical records for retrospective analysis. Outcome measures were technical success, early and late complications, and primary and secondary patency rates. RESULTS: A total of 37 stent graft repairs of AVG pseudoaneurysms were performed in 35 patients (42.9% men; mean age 66.9 years). The mean time from AVG creation to pseudoaneurysm repair was 69 months. The indications of treatment (as per the institutional policy) were large pseudoaneurysm (56.7%), impending rupture (27.1%), and bleeding (16.2%). Mean pseudoaneurysm diameter was 23.0 mm. The most common diameter and length of stent graft used were 7 mm (67.6%) and 50 mm (48.6%), respectively. Technical success was 100%. Only one early complication occurred after stent graft repair, which was due to recurrence of the pseudoaneurysm as a result of a short landing zone. Late complications included infection (17.1%) and thrombosis (37.1%). The 1, 6, and 12 month primary patency rates were 89.2%, 55.5%, and 22.0%, respectively. The 1, 6, and 12 month secondary patency rates were 100%, 88.6%, and 78.6%, respectively. The median follow up was 12.3 months. CONCLUSIONS: The study demonstrates that endovascular stent graft repair is an effective and safe alternative therapy for AVG pseudoaneurysms. However, the rate of thrombosis and infection was high and needs to be balanced against open surgery in future studies.


Subject(s)
Aneurysm, False/surgery , Arteriovenous Shunt, Surgical/adverse effects , Blood Vessel Prosthesis Implantation/instrumentation , Blood Vessel Prosthesis , Endovascular Procedures/instrumentation , Kidney Failure, Chronic/therapy , Renal Dialysis , Stents , Aged , Aneurysm, False/diagnostic imaging , Aneurysm, False/etiology , Aneurysm, False/physiopathology , Blood Vessel Prosthesis Implantation/adverse effects , Computed Tomography Angiography , Endovascular Procedures/adverse effects , Female , Humans , Kaplan-Meier Estimate , Kidney Failure, Chronic/diagnosis , Male , Middle Aged , Phlebography , Postoperative Complications/etiology , Retrospective Studies , Risk Factors , Time Factors , Treatment Outcome , Vascular Patency
16.
J Vasc Access ; 17(5): 392-396, 2016 Sep 21.
Article in English | MEDLINE | ID: mdl-27470251

ABSTRACT

BACKGROUND: Declining kidney function leads to progressively dysregulated mineral homeostasis and contributes to vascular calcification and a pro-inflammatory milieu, both of which play a critical role in loss of dialysis vascular access patency. We designed this study to examine the relationship between markers of bone and mineral metabolism, vitamin D replacement medications, and vascular access outcomes. We hypothesized that higher levels of calcium, phosphorous, parathyroid hormone (PTH), and albumin are independently associated with vascular access patency and that vitamin D supplementation is associated with lower risk of access failure. METHODOLOGY: We abstracted data on 204 consecutive patients referred for angiographic evaluation of their permanent arteriovenous access over a 25-month period. We followed patients from the time of access salvage until subsequent referral for access failure. RESULTS: The incidence of vascular access failure did not differ by serum phosphorus, PTH, calcium, calcium-phosphorus product or albumin level. Patients receiving any vitamin D replacement therapy, however, had a lower incidence of access failure compared to those receiving no therapy. Those receiving vitamin D3 therapy with or without paricalcitol (Zemplar, Abbot Laboratories, Abbot Park, IL) or calcitriol had an adjusted HR = 0.18 compared to those receiving no vitamin D therapy. CONCLUSIONS: This study suggests a relationship between vitamin D3 usage and better vascular access patency, independent of the effect of vitamin D on PTH. Though this relationship needs more rigorous investigation prior to clinical application, the known differences in the pro- and anti-inflammatory effects of various vitamin D metabolites provide a potential mechanism for these clinical observations.


Subject(s)
Arteriovenous Shunt, Surgical/instrumentation , Blood Vessel Prosthesis Implantation/instrumentation , Blood Vessel Prosthesis , Kidney Failure, Chronic/therapy , Renal Dialysis , Vascular Patency , Vitamin D Deficiency/blood , Vitamin D/blood , Adult , Aged , Angiography , Arteriovenous Shunt, Surgical/adverse effects , Biomarkers/blood , Blood Vessel Prosthesis Implantation/adverse effects , Calcium/blood , Cholecalciferol/therapeutic use , Female , Graft Occlusion, Vascular/diagnostic imaging , Graft Occlusion, Vascular/epidemiology , Graft Occlusion, Vascular/physiopathology , Graft Occlusion, Vascular/prevention & control , Humans , Incidence , Kidney Failure, Chronic/blood , Kidney Failure, Chronic/diagnosis , Kidney Failure, Chronic/epidemiology , Male , Middle Aged , Parathyroid Hormone/blood , Phosphorus/blood , Protective Factors , Renal Dialysis/adverse effects , Retrospective Studies , Risk Factors , Serum Albumin, Human/metabolism , Time Factors , Treatment Outcome , Vitamin D/therapeutic use , Vitamin D Deficiency/diagnosis , Vitamin D Deficiency/drug therapy , Vitamin D Deficiency/epidemiology , Wisconsin/epidemiology
17.
J Cardiovasc Surg (Torino) ; 57(5): 712-5, 2016 Oct.
Article in English | MEDLINE | ID: mdl-27406396

ABSTRACT

Use of endovascular means is gaining ever greater acceptance in the treatment of aorto-iliac aneurysms. Especially, the treatment of patients with common iliac aneurysms (CIAs) may be very challenging due to the complexity of the underlying disease with often involvement of the hypogastric artery. Additionally, the variety of endovascular therapeutic options such as the use of iliac branch devices, parallel grafts, the bell-bottom technique or coil embolization of the hypogastric artery and overstenting of the origin represents significant limitation regarding the presentation of a clear and robust endovascular therapeutic algorithm. Aim of the present article was the demonstration of the institutional experience with the endovascular management of CIAs in order to provide a clinical recommendation and algorithm.


Subject(s)
Algorithms , Blood Vessel Prosthesis Implantation , Critical Pathways , Endovascular Procedures , Iliac Aneurysm/surgery , Blood Vessel Prosthesis , Blood Vessel Prosthesis Implantation/adverse effects , Blood Vessel Prosthesis Implantation/instrumentation , Endovascular Procedures/adverse effects , Endovascular Procedures/instrumentation , Humans , Iliac Aneurysm/diagnostic imaging , Prosthesis Design , Risk Factors , Stents , Treatment Outcome
18.
J Vasc Interv Radiol ; 27(7): 954-60, 2016 Jul.
Article in English | MEDLINE | ID: mdl-27234482

ABSTRACT

PURPOSE: To determine the feasibility of prophylactic intraoperative abdominal aortic aneurysm (AAA) sac embolization using a mixture of N-butyl cyanoacrylate/Lipiodol/ethanol (NLE) with proximal neck aortic balloon occlusion during endovascular aneurysm repair (EVAR) to prevent the occurrence of endoleak and aneurysm sac expansion. MATERIALS AND METHODS: Prophylactic intraoperative AAA sac embolization was performed in 24 patients with an infrarenal neck angulation > 60° (n = 16) or AAA sac diameter > 60 mm (n = 17). AAA sac pressure was continuously measured with a 3-F catheter inserted into the AAA sac. The systolic sac pressure index (SPI) was calculated as the ratio of systolic AAA sac pressure to the simultaneously measured systolic aortic pressure, and was measured with and without proximal neck aortic balloon occlusion. The aneurysm sac was embolized with NLE during proximal neck aortic balloon occlusion immediately after EVAR. Endoleak and AAA sac diameter were evaluated by enhanced computed tomography and subtraction magnetic resonance imaging at 6 months and yearly after EVAR. RESULTS: Mean SPIs after EVAR with and without proximal neck aortic balloon occlusion were 0.36 and 0.57, respectively. There were no adverse events related to intraoperative sac embolization. Follow-up imaging (mean, 12.1 mo) revealed three minor endoleaks (12.5%) and no aneurysm sac expansion. CONCLUSIONS: Prophylactic intraoperative sac embolization with NLE during proximal neck aortic balloon occlusion was safe and feasible and may reduce endoleaks and prevent sac expansion after EVAR in patients with unfavorable anatomic factors.


Subject(s)
Aorta, Abdominal/surgery , Aortic Aneurysm, Abdominal/therapy , Balloon Occlusion , Blood Vessel Prosthesis Implantation , Embolization, Therapeutic/methods , Enbucrilate/administration & dosage , Endovascular Procedures , Ethanol/administration & dosage , Ethiodized Oil/administration & dosage , Aged , Aged, 80 and over , Aorta, Abdominal/diagnostic imaging , Aorta, Abdominal/physiopathology , Aortic Aneurysm, Abdominal/diagnostic imaging , Aortic Aneurysm, Abdominal/physiopathology , Aortic Aneurysm, Abdominal/surgery , Aortography/methods , Arterial Pressure , Balloon Occlusion/adverse effects , Blood Vessel Prosthesis , Blood Vessel Prosthesis Implantation/adverse effects , Blood Vessel Prosthesis Implantation/instrumentation , Computed Tomography Angiography , Disease Progression , Embolization, Therapeutic/adverse effects , Enbucrilate/adverse effects , Endoleak/etiology , Endoleak/prevention & control , Endovascular Procedures/adverse effects , Endovascular Procedures/instrumentation , Ethanol/adverse effects , Ethiodized Oil/adverse effects , Feasibility Studies , Female , Humans , Magnetic Resonance Angiography , Male , Multidetector Computed Tomography , Risk Factors , Stents , Time Factors , Treatment Outcome
19.
Vasc Med ; 21(3): 223-38, 2016 06.
Article in English | MEDLINE | ID: mdl-27013644

ABSTRACT

The introduction of fenestrated stent grafts (SGs) to treat abdominal aortic aneurysms (AAAs) with short proximal necks began in 1999. Nowadays, the whole visceral aorta can be treated totally by endovascular means. The established use of fenestrated devices to treat complex AAAs as a first-line management option has been previously reported. An up-to-date evaluation of the literature was performed including all types of publications regarding the use of fenestrated technology to repair complex AAAs. Fenestrated repair is now an established alternative to hybrid/chimney/snorkel repairs. However, specific criteria and prerequisites are required for the use and improvement of this method. Multiple device morphologies have been used incorporating the visceral arteries in various combinations. This modular strategy connects different devices (bridging covered stents and bifurcated SGs) with the aortic main body, thus excluding the aneurysm from the circulation. Precise deployment of the fenestrated SG is mandatory for successful visceral vessel revascularization. Accurate SG sizing and customization, a high level of technical skill, and facilities with modern imaging techniques including 3D road mapping and dedicated hybrid rooms are required. Most experience has been with the custom-made Zenith Cook platform, although off-the-shelf devices have been recently implanted. More complex repairs have been performed over the last few years, but device complexity has also increased. Perioperative, mid-term, and a few recently reported long-term results are encouraging. Secondary interventions remain the main problem, similar to that observed after traditional endovascular abdominal aortic aneurysm repair (EVAR).


Subject(s)
Aortic Aneurysm, Abdominal/surgery , Blood Vessel Prosthesis Implantation/instrumentation , Blood Vessel Prosthesis , Endovascular Procedures/instrumentation , Stents , Aortic Aneurysm, Abdominal/diagnostic imaging , Aortic Aneurysm, Abdominal/mortality , Aortography , Blood Vessel Prosthesis Implantation/adverse effects , Blood Vessel Prosthesis Implantation/mortality , Endovascular Procedures/adverse effects , Endovascular Procedures/mortality , Female , Humans , Male , Postoperative Complications/therapy , Prosthesis Design , Treatment Outcome
20.
Asian Cardiovasc Thorac Ann ; 24(7): 699-702, 2016 Sep.
Article in English | MEDLINE | ID: mdl-26113732

ABSTRACT

An 84-year-old man with a thoracoabdominal aortic aneurysm was treated using a fenestrated stent graft with a preloaded guidewire system under local anesthesia. He suffered from severe chronic obstructive pulmonary disease. We successfully placed 4 bridging stent grafts for perfusion of the celiac artery, superior mesenteric artery, and bilateral renal arteries via the 4 fenestrations. A preloaded wire system was used to insert a catheter into the celiac artery from the left brachial artery. Our findings indicate that a fenestrated stent graft with a preloaded wire system may expand the indication for treating thoracoabdominal aortic aneurysms in high-risk patients.


Subject(s)
Aortic Aneurysm, Thoracic/surgery , Blood Vessel Prosthesis Implantation/instrumentation , Blood Vessel Prosthesis , Endovascular Procedures/instrumentation , Prosthesis Design , Stents , Aged, 80 and over , Anesthesia, Local , Aortic Aneurysm, Thoracic/diagnostic imaging , Aortography/methods , Computed Tomography Angiography , Humans , Male , Treatment Outcome
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