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1.
J Vasc Surg ; 65(1): 46-51, 2017 Jan.
Article in English | MEDLINE | ID: mdl-27575811

ABSTRACT

OBJECTIVE: The influence of endovascular aneurysm repair (EVAR) on renal function is of high concern. The question whether stent graft fixation type plays a significant role in renal outcome after EVAR is still debated. However, other factors, such as repeated contrast medium exposure, should also be considered. METHODS: We performed a two-center, stratified-cohort case control study to evaluate the influence of last-generation abdominal endografts with suprarenal (SR) vs infrarenal (IR) fixation on renal function. RESULTS: From a total of 276 patients, 134 were treated with IR fixation (group A) and 142 with SR fixation (group B) stent grafts. There was no significant difference in intraoperative contrast medium use (mean 120.0 mL group A vs 104.8 mL; P = .087) between the two cohorts. Overall, 11.2% of the patients (31/276) showed a relevant decline (≥20%) of estimated glomerular filtration rate (eGFR) postoperative and 11.5% (31/269) after 12 months. Furthermore, 19/134 (14.2%) patients in group A and 12/142 (8.5%) patients in group B showed a postoperative decrease of eGFR ≥20% (P = .132). Comparing the 12-month follow up, there was also no significant difference between the two groups (group A, n = 18/134; group B, n = 13/135; P = .329). Patients with only one contrast-enhanced computed tomography scan postoperatively (4/102; 3.9%) showed significant less renal deterioration after 12 months compared with the rest of the study collectively (27/166; 16.9%; P = .002). Comparing IR vs SR fixation in these patients, there was no significant difference between the two groups. One patient (1/35; 2.9%) with IR fixation (group A) and 3/67 (4.5%) with SR fixation (group B) showed a decline in eGFR values of ≥20% after 12 months (P = 1.0). CONCLUSIONS: Our study showed no significant difference in renal impairment between SR and IR fixation in EVAR for IR abdominal aortic aneurysm. However, significantly more renal deterioration was observed in patients with increased postoperative contrast medium expose. Therefore, alternatives such as contrast- enhanced duplex ultrasound or magnetic resonance imaging for EVAR surveillance should be considered.


Subject(s)
Aortic Aneurysm, Abdominal/surgery , Aortography/adverse effects , Blood Vessel Prosthesis Implantation/adverse effects , Computed Tomography Angiography/adverse effects , Contrast Media/adverse effects , Endovascular Procedures/adverse effects , Glomerular Filtration Rate/drug effects , Kidney/drug effects , Adult , Aged , Aged, 80 and over , Aortic Aneurysm, Abdominal/diagnostic imaging , Aortography/methods , Blood Vessel Prosthesis , Blood Vessel Prosthesis Implantation/instrumentation , Contrast Media/administration & dosage , Endovascular Procedures/instrumentation , Female , Germany , Humans , Kidney/physiopathology , Male , Middle Aged , Predictive Value of Tests , Prosthesis Design , Retrospective Studies , Risk Factors , Stents , Time Factors , Treatment Outcome
2.
J Vasc Surg ; 62(4): 848-54, 2015 Oct.
Article in English | MEDLINE | ID: mdl-26091587

ABSTRACT

OBJECTIVE: The aim of this study was to prospectively evaluate the early and late 7-year experience with the Endurant bifurcated stent graft system (Medtronic, Santa Rosa, Calif) in patients with abdominal aortic aneurysms. METHODS: Between November 14, 2007, and December 2013, 712 consecutive high-risk patients with abdominal aortic aneurysms underwent elective or urgent placement of an Endurant bifurcated endograft in our institution. The included patients were consecutive (all comers) and treated independently from their morphologic eligibility for use of the Endurant device based on the instructions for use. The primary study outcome was freedom from all-cause reintervention. RESULTS: The median follow-up was 19.2 months (interquartile range, 6.3-35.9 months). Overall, 517 patients (72.6%) were treated on the basis of instructions for use conditions. On the other hand, 195 patients (27.4%) had morphologic data not consistent with the recommendations for the use of the Endurant system. The 30-day mortality was 1.4% (10 of 712). Nine patients (1.2%) were lost to follow-up because of relocation abroad. The overall mortality rate was 14.74% (101 of 703). Overall survival rate was 92.3% at 1 year, 86.4% at 2 years, and 65% at 5 years. Overall freedom from reintervention rate was 93.3%, 86.4%, and 65% at 1 year, 2 years, and 5 years, respectively. Five patients (0.7%) underwent a surgical conversion and explantation of the Endurant device. The reasons were endograft infection (n = 1), endoleak type Ia (n = 1), endoleak type II (n = 1), endograft and limb thrombotic occlusion (n = 1), and endotension (n = 1). The overall iliac limb occlusion rate was 2.1% (15 of 712). CONCLUSIONS: The performance of the Endurant stent graft during a period of 7 years under real-life conditions was good, with low incidence of reinterventions and endoleaks.


Subject(s)
Aortic Aneurysm, Abdominal/surgery , Blood Vessel Prosthesis , Stents , Aged , Aortic Aneurysm, Abdominal/diagnostic imaging , Aortic Aneurysm, Abdominal/mortality , Female , Humans , Male , Postoperative Complications , Prospective Studies , Prosthesis Design , Radiography , Reoperation , Tomography Scanners, X-Ray Computed , Treatment Outcome
3.
J Vasc Surg ; 60(5): 1125-1131, 2014 Nov.
Article in English | MEDLINE | ID: mdl-24974782

ABSTRACT

OBJECTIVE: Several studies have confirmed the excellent early performance of the Endurant (Medtronic Endovascular, Santa Rosa, Calif) endoprosthesis to treat abdominal aortic aneurysms (AAAs). However, data about the long-term durability of the device are still lacking. We conducted this prospective two-center single-arm study to assess the late outcomes of the endograft in patients undergoing AAA repair. METHODS: An intention-to-treat analysis was performed for all comers with AAAs who were implanted with an Endurant endograft between November 2007 and December 2010. Clinical and radiologic data were prospectively collected and analyzed. The primary end point was any AAA-related reintervention. Secondary end points were overall mortality, aneurysm shrinkage, all types of endoleak, and device-related complications. RESULTS: During the study period, 273 patients underwent implantation of the Endurant stent graft. The median follow-up time for the primary end point was 42 months (interquartile range, 30.7-50.7). AAA-related reinterventions were required in 26 patients (10%), resulting in a reintervention-free probability of 93%, 90%, and 87% at 3, 4, and 5 years, respectively. The leading cause for reintervention was iliac limb occlusion (n = 10). Only one AAA-related death (0.3%) was reported within an overall mortality of 29% (n = 78). The median aneurysm shrinkage was 9 mm (interquartile range, 3-15). Five type I (2%) and one type III (0.4%) endoleaks were identified. No proximal and two distal limb migrations (1%) were observed. CONCLUSIONS: Our study confirms late durability of the Endurant endoprosthesis for AAA repair, with very encouraging freedom from reintervention rates and overall outcomes.


Subject(s)
Aortic Aneurysm, Abdominal/surgery , Blood Vessel Prosthesis Implantation/instrumentation , Blood Vessel Prosthesis , Endovascular Procedures/instrumentation , Stents , Aged , Aged, 80 and over , Aortic Aneurysm, Abdominal/diagnosis , Aortic Aneurysm, Abdominal/mortality , Aortography/methods , Blood Vessel Prosthesis Implantation/adverse effects , Blood Vessel Prosthesis Implantation/mortality , Disease-Free Survival , Endoleak/etiology , Endoleak/surgery , Endovascular Procedures/adverse effects , Endovascular Procedures/mortality , Female , Germany , Graft Occlusion, Vascular/etiology , Graft Occlusion, Vascular/surgery , Humans , Intention to Treat Analysis , Kaplan-Meier Estimate , Male , Middle Aged , Proportional Hazards Models , Prospective Studies , Prosthesis Design , Reoperation , Time Factors , Tomography, X-Ray Computed , Treatment Outcome
4.
J Vasc Surg ; 56(2): 285-90, 2012 Aug.
Article in English | MEDLINE | ID: mdl-22554426

ABSTRACT

OBJECTIVE: To present endovascular techniques in the treatment of juxtarenal aortic aneurysms (JAAAs) in relation to surgical repair; this is the "gold standard." METHODS: Between January 2008 and December 2010, 90 consecutive patients were diagnosed with primary degenerative JAAAs (≥5.0 cm) and assigned prospectively to different operative strategies on the basis of morphologic and clinical characteristics. In particular, 59 patients were treated by endovascular means such as fenestrated endovascular abdominal aortic repair (f-EVAR, n = 29) or chimney endovascular abdominal aortic repair (ch-EVAR, n = 30) endografting, and 31 patients underwent open repair (OR, n = 31). RESULTS: Early procedure-related and all-cause (30-day) procedure-related mortality was 0% for the endovascular group and 6.4% (n = 2/31) for the OR group, due to systemic inflammatory response syndrome with consecutive multi-organ failure (P = .023). Persistent postoperative hemodialysis occurred only after OR (2/31; 6.4%). The overall estimated pre- and postoperative median estimated glomerular filtration rate and creatinine values were similar in the three subgroups. There was one left renal artery occlusion for each endovascular subgroup, which presented as flank pain and was treated by iliaco-renal bypass in both cases. Transfusion requirements and length of hospital stay were significantly less in the endovascular group (P = .014 and P = .004, respectively). CONCLUSIONS: Endovascular treatment of JAAA is a safe alternative for the short-term management of JAAA.


Subject(s)
Aortic Aneurysm, Abdominal/surgery , Blood Vessel Prosthesis Implantation , Blood Vessel Prosthesis , Prosthesis Design , Aged , Aged, 80 and over , Aortic Aneurysm, Abdominal/mortality , Endovascular Procedures , Female , Humans , Length of Stay , Male , Middle Aged , Prospective Studies , Renal Artery Obstruction/etiology , Stents
5.
J Endovasc Ther ; 18(5): 720-5, 2011 Oct.
Article in English | MEDLINE | ID: mdl-21992644

ABSTRACT

PURPOSE: To investigate in-stent stenosis (ISS) after carotid artery stenting (CAS) in a large series of patients over a study period of 9 years. METHODS: From January 2001 to December 2010, a total of 1738 carotid procedures for primary carotid stenosis were performed in our institution. Of the 574 patients having stent-supported angioplasty, 482 (84.2%) were enrolled in a standardized follow-up program that included duplex ultrasound scans at 1 month, 6 months, 12 months, and yearly thereafter or at any time a neurological event was present or suspected. ISS was defined as >80% stenosis as determined by duplex ultrasound (80% to 99% stenosis indicated by a PSV >250 cm/s + EDV >120 cm/s or an ICA/CCA ratio >3.2). RESULTS: The mean follow-up was 36.5±21.6 months (range 14-119), during which time 16 (3.3%) patients (11 men; mean age 68.7±6.7 years, range 60-81) developed >80% ISS. The mean time from primary CAS to ISS detection was 7.8±3.5 months (range 0-45). Six (37.5%) of the 16 patients were symptomatic, with transient ischemic attack (n = 2), stroke (n = 2), and amaurosis fugax (n = 2). Thirteen (81.3%) ISS patients were treated by endovascular means, while the other 3 (18.7%) had the stent removed owing to migration. The primary and assisted primary patency rates were 68.8% and 81.3%, respectively; the freedom of new neurological events during follow-up was 75%. CONCLUSION: ISS >80% after CAS was not common. However, it is an ongoing process that requires frequent repeat interventions due to recurrence after primary treatment by balloon angioplasty alone. Additionally, surgery may be necessary in patients with neurological deficits and recurrent significant ISS.


Subject(s)
Angioplasty, Balloon/instrumentation , Carotid Stenosis/therapy , Stents , Aged , Aged, 80 and over , Angioplasty, Balloon/adverse effects , Carotid Stenosis/complications , Carotid Stenosis/diagnostic imaging , Carotid Stenosis/surgery , Cerebrovascular Disorders/etiology , Endarterectomy, Carotid , Female , Germany , Humans , Kaplan-Meier Estimate , Male , Middle Aged , Prosthesis Design , Recurrence , Retreatment , Retrospective Studies , Severity of Illness Index , Time Factors , Treatment Outcome , Ultrasonography, Doppler, Duplex , Vascular Patency
6.
J Endovasc Ther ; 16(6): 708-13, 2009 Dec.
Article in English | MEDLINE | ID: mdl-19995109

ABSTRACT

PURPOSE: To evaluate the efficiency of totally percutaneous endovascular aortic aneurysm repair in a large cohort of patients and to define risk factors for failure with a 10-F vascular closure system. METHODS: A prospective study examined the feasibility and safety of percutaneous femoral artery closure with a single Prostar XL 10-F vascular closure device applied in conjunction with the preclose technique. Between January 2004 and December 2005, 535 consecutive patients were treated for aortic aneurysmal disease. Thirty-five patients were excluded, leaving 500 patients (417 men; mean age 72+/-6.6 years) treated for aortic aneurysms using the Talent or Zenith stent-graft delivered through sheaths measuring 14-F (191, 21.2%), 16-F (33, 3.7%), 18-F (179, 19.8%), 20-F (2, 0.2%), 22-F (228, 25.2%), and 24-F (271, 29.9%). Primary clinical success was defined as the freedom from additional early or late procedures to treat any complication at the access site. Data were analyzed to reveal any correlation of access site complications or early/late repairs to operator experience or risk factors (obesity, extensive femoral artery calcification, and previous interventions/scars in the groin). RESULTS: Primary success was achieved in 96.1% of all percutaneous approaches. Twenty-three patients developed early (n = 16) or late (n = 7) complications at the access vessel; in 12 cases, hemostasis was achieved using pledgets with the Prostar sutures. No wound complications were recorded. The need for early conversion to an open access correlated with CFA calcification (OR 74.5, 95% CI 17.8 to 310.7; p<0.001) and operator experience (OR 43.2, 95% CI 9.8 to 189.0; p<0.001). The risk of late access site repairs was significantly higher in the presence of a groin scar (OR 48.8, 95% CI 9.2 to 259.0; p<0.001). Correlation of sheath size with early conversion to open access was weaker compared to all the other factors (OR 1.2, CI 95% 1.0 to 1.4; p<0.05). Obesity was not a risk factor for any complication. CONCLUSION: Percutaneous EVAR using the Prostar XL is safe, with minimal early and late complications. Operator experience is one of the most significant predictors of success. Anterior wall calcification and severe fibrosis of the access vessel are also predictors of primary failure, whereas obesity and sheath size are not.


Subject(s)
Aortic Aneurysm, Abdominal/surgery , Aortic Aneurysm, Thoracic/surgery , Blood Vessel Prosthesis Implantation/methods , Catheterization, Peripheral , Femoral Artery , Hemorrhage/prevention & control , Hemostatic Techniques/instrumentation , Aged , Blood Vessel Prosthesis , Blood Vessel Prosthesis Implantation/adverse effects , Blood Vessel Prosthesis Implantation/instrumentation , Catheterization, Peripheral/adverse effects , Clinical Competence , Feasibility Studies , Female , Hemorrhage/etiology , Hemostatic Techniques/adverse effects , Humans , Male , Odds Ratio , Proportional Hazards Models , Prospective Studies , Prosthesis Design , Punctures , Risk Assessment , Risk Factors , Stents , Treatment Failure
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