Long-Term Results of Femorodistal Sequential Composite-Bypass Combining Heparin-Bonded PTFE-Prosthesis and Autologous Vein Using the Deutsch Bridge Technique in Critical Limb-Threatening Ischemia.

BACKGROUND: Autologous vein bypass provides excellent long-term results in critical limb-threatening ischemia (CLTI), but a substantial portion of patients have insufficient vein length. In limbs with two distal outflow vessels and limited vein length, a vascular prosthesis may be combined with autologous vein for a sequential composite bridge bypass (SCBB). Results regarding graft function, limb salvage and reinterventions are presented. METHODS: Between January 2010 and December 2019, 47 consecutive SCBB operations with a heparin-bonded PTFE-prosthesis and autologous vein were performed. Grafts were followed with a duplex scan with prospective documentation in a computerized vascular database. Retrospective analysis of graft patency, limb salvage and patient survival was performed. RESULTS: Mean follow-up was 34 months (range 1-127 months). 30-day mortality was 10.6% and 5-year patient survival 32%. Postoperative bypass occlusion occurred in 6.4% and late occlusions or graft stenoses in 30%. Two prostheses developed late infection and seven legs were amputated. Primary, primary assisted, secondary patency and limb salvage rate were 54%, 63%, 66% and 85% after 5 years, respectively. CONCLUSIONS: SCBB patency and limb salvage were good despite a high early postoperative mortality. Combination of a heparin-bonded PTFE-prosthesis and autologous vein appears to be a valuable tool in CLTI in case of insufficient vein.

A rare cause of stroke: fail-implanted venous port catheter system - a case report.

BACKGROUND: We present the case of a 75-year-old female with acute embolic cerebral infarction caused by a fail-implanted venous port catheter system in the left subclavian artery. CASE PRESENTATION: A 75-year-old woman presented to our emergency room after acute onset of a right-sided hemiparesis and dysarthria. Within 2 days after admission, she developed a left-sided hemiparesis, ataxia with concordant gait disturbance and incoordination of the left upper limb. DWI-MRI showed acute multiple infarcts in both cerebral and cerebellar hemispheres. Laboratory examination, 24-h Holter electrocardiography and transthoracic echocardiography provided no pathological findings. Further examination revealed an arterially fail-implanted port catheter, placed in the left subclavian artery with its tip overlying the ascending aorta, as the source of cerebral embolism. CONCLUSION: This is the first case report of thromboembolic, cerebral infarction due to a misplaced venous port catheter in the subclavian artery, emphasizing the imperative need for a thorough diagnostic workup, when embolism is suspected but cannot be proven at first glance.

Influence of Extracellular RNAs, Released by Rheumatoid Arthritis Synovial Fibroblasts, on Their Adhesive and Invasive Properties.

Extracellular RNA (exRNA) has been characterized as a molecular alarm signal upon cellular stress or tissue injury and to exert biological functions as a proinflammatory, prothrombotic, and vessel permeability-regulating factor. In this study, we investigated the contribution of exRNA and its antagonist RNase1 in a chronic inflammatory joint disease, rheumatoid arthritis (RA). Upon immunohistochemical inspection of RA, osteoarthritis (OA), and psoriatic arthritis synovium, exRNA was detectable only in the RA synovial lining layer, whereas extracellular DNA was detectable in various areas of synovial tissue. In vitro, exRNA (150-5000 nt) was released by RA synovial fibroblasts (RASF) under hypoxic conditions but not under normoxia or TNF-α treatment. RNase activity was increased in synovial fluid from RA and OA patients compared with psoriatic arthritis patients, whereas RNase activity of RASF and OASF cultures was not altered by hypoxia. Reduction of exRNA by RNase1 treatment decreased adhesion of RASF to cartilage, but it had no influence on their cell proliferation or adhesion to endothelial cells. In vivo, treatment with RNase1 reduced RASF invasion into coimplanted cartilage in the SCID mouse model of RA. We also analyzed the expression of neuropilins in synovial tissue and SF, as they may interact with vascular endothelial growth factor signaling and exRNA. The data support the concepts that the exRNA/RNase1 system participates in RA pathophysiology and that RASF are influenced by exRNA in a prodestructive manner.

Secondary procedures after aortic aneurysm repair with fenestrated and branched endografts.

PURPOSE: To investigate the secondary procedures in patients with previous endovascular aortic repair by fenestrated or branched stent-grafts for aneurysms involving the renal and visceral vessels. METHODS: Between January 2001 and May 2010, 107 consecutive high-risk patients (97 men; mean age 73 years, range 50-86) with aortic aneurysms involving the renal and visceral arteries were treated with endovascular techniques. A custom-made Zenith graft was used in all patients. All secondary graft-related procedures performed in the perioperative period and during follow-up were analyzed. Estimates of survival, freedom from migration/type I endoleak, and freedom from any device-related secondary procedures were assessed with Kaplan-Meier analyses. RESULTS: The 30-day mortality rate was 1.9%. During follow-up (mean 25 months, range 1-94), 34 secondary procedures were performed in 28 (26.2%) patients for 6 (17.6%) limb graft stenoses/thromboses (5.6% of 107 cases), 8 (23.5%) in-stent visceral vessel stenoses/occlusions (7.5% of 107 cases), 8 (23.5%) migrations/type I endoleaks with/without visceral stent fractures (7.5% of 107 cases), and 12 (35.3%) type III endoleaks (9.3% of 107 cases). The mean interval between the primary and secondary procedures was 12.9 months (range 1-68). In 26 (76.5%) of 34 cases, a secondary endovascular procedure was performed; in the remaining 8 (23.5%) cases, the complication was treated surgically. The secondary procedure was unsuccessful in 9 cases of visceral vessel compromise (failure to cannulation, stent fracture/migration, in-stent stenosis/occlusion). Estimated 3-year survival was 77%, while the 3-year rate for freedom from any device-related secondary procedure was 75.5%. CONCLUSION: The incidence of early and late complications requiring a secondary procedure after treatment with fenestrated or branched devices was not negligible. Endoleak type III represented the most common cause for reintervention during follow-up. Secondary procedures performed for visceral vessel compromise had high rates of treatment failure. Accurate preoperative planning, the advent of new materials/techniques, and strict follow-up could be the key factors to improving the results of fenestrated or branched stent-graft interventions and to reduce the rate of secondary procedures.

Migratory potential of rheumatoid arthritis synovial fibroblasts: additional perspectives.

Cell migration is a central part of physiological and pathophysiological processes including wound healing, immune defense, matrix remodeling and organ homeostasis. Different cell types have migratory potential including cells of the immune system and cells required in wound healing and tissue repair. These cells migrate locally through the tissue to the site of damage. The fibroblast is a central cell type of wound healing. In rheumatoid arthritis (RA), activated synovial fibroblasts (SFs) have the ability to invade joint cartilage, actively contributing to joint destruction in RA. Recently, RASFs have been shown to be able to migrate to non-affected areas and joints through the blood stream and to invade distant cartilage. RASFs most likely use similar mechanisms comparable to lymphocytes and tumor cells for long-distance and vascular trans-migration. Future experiments will address the goal to keep the transformed-appearing fibroblasts in the affected joints using therapeutical strategies that inhibit the pathophysiological changes of transformed-appearing RASFs but do not interfere with the physiological processes of 'normal' fibroblasts.

Percutaneous endovascular aortic aneurysm repair: a prospective evaluation of safety, efficiency, and risk factors.

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.

Vascular endostapling: new concept for endovascular fixation of aortic stent-grafts.

PURPOSE: To evaluate the feasibility of a new vascular endostapling system in treating infrarenal abdominal aortic aneurysms using commercially available endografts. METHODS: Eight patients (6 men; mean age 71 years, range 59-82) underwent endovascular aneurysm repair (EVAR) using Talent or Zenith stent-grafts and the Anson Refix clip, which provides transmural aortic fixation of the endoprosthesis with high pullout force proportional to the number of the clips deployed. RESULTS: Twenty (69%) of the 29 endostaples were successfully implanted and secured with the endostaple system; 9 clips that did not fully penetrate the graft and tissue due to severe calcification of the neck were retracted successfully into the delivery device. The delivery time from insertion of the Refix delivery catheter to its withdrawal was a mean 57 minutes (range 20-102) over and above the regular stent-graft procedure. Notably, the delivery time was reduced as the learning curve was passed: mean 89.75 minutes in the first 4 cases versus 27.5 minutes in the last 4. No endostaple migrated or was lost from the intended deployment site based on radiological imaging. No patients had evidence of perioperative endoleak based on computed tomography. No endograft-related complications have been documented during follow-up at 30 days. CONCLUSION: The initial experience established the safety and feasibility of EVAR using the Anson Refix endostapling system. However, further clinical evaluation is mandatory to draw robust conclusions about the utility of this new concept for fixation of aortic stent-grafts.

Fenestrated endografting for aortic aneurysm repair: a 7-year experience.

PURPOSE: To present a 7-year single-center clinical experience with fenestrated endografts and side branches. METHODS: Between April 1999 and August 2006, 63 patients (57 men; mean age 70.5+/-11.6 years, range 25-89) received custom-designed Zenith fenestrated endoprostheses for a variety of aneurysms (59 abdominal, 1 thoracoabdominal, and 3 thoracic). They were all unsuitable for standard EVAR owing to short aortic necks and high risk for open surgery. RESULTS: Nineteen tube grafts and 44 composite bifurcated grafts with a total of 122 fenestrations and 58 side branches were used. Technical success was achieved in 55 (87.3%) patients and in 118 (96.7%) vessels. Treatment success was 93.7%. The mean follow-up was 23+/-18 months (median 14, range 6-77). Overall, 9 (7.4%) visceral branches were lost: 4 intraoperative, 2 perioperative, and 3 late. There were 12 (19.0%) endoleaks identified: 5 (7.9%: 4 type Ia and 1 fenestration-related type III) primary and 7 (11.1%: 4 type II, 1 type I, and 2 type III) secondary endoleaks; 4 resolved, 4 were treated, and 4 are under observation. At 77 months, 75.3% of patients were free of a reintervention. All reinterventions were performed within the first 14 months. Fourteen cases of renal impairment were seen [6 permanent (only 1 on dialysis) and 8 transient]. One (1.6%) conversion and 1 (1.6%) rupture were recorded; aneurysm-related mortality was 4.8% (3/63). CONCLUSION: The favorable outcomes in this study, which encompasses the team's learning curve with fenestrated endografts and side branches, support the use of these devices in selected patients.

Hybrid thoracoabdominal aneurysm repair with simultaneous antegrade visceral revascularization and supra-aortic debranching from the ascending aorta.

PURPOSE: To describe a hybrid technique involving combined antegrade revascularization of both supra-aortic and visceral arteries and complete exclusion of a dissecting thoracoabdominal aortic aneurysm (TAAA). TECHNIQUE: A 46-year-old man had a dissecting TAAA involving the left subclavian artery (LSA) and the descending thoracic and abdominal aorta down to the left common iliac artery. The ascending aorta was the only feasible source of inflow to the cerebral and visceral vessels. Via a median thoracolaparotomy, the supra-aortic and visceral arteries were dissected, and an octopus graft was implanted using 3 bifurcated Dacron grafts. An 18-x9-mm bifurcated Dacron graft was anastomosed in an end-to-side fashion to the ascending aorta, the brachiocephalic trunk, and the left common carotid artery. A 16-x8-mm bifurcated Dacron graft was sutured end-to-side to the celiac artery and superior mesenteric artery. A third 12-x7-mm bifurcated graft was sutured to both renal arteries. In a second step, 3 tapered custom-made thoracic Zenith TX2 endografts were used to repair the thoracic and the thoracoabdominal aorta. A bifurcated Zenith AAA device was used to treat the aneurysm at the level of the infrarenal aorta and both iliac arteries. Despite covering the LSA and all intercostal and lumbar arteries, the patient developed only a temporary paresis of the left leg. Computed tomography showed complete exclusion of the aneurysm and normal flow to the supra-aortic and visceral arteries. CONCLUSION: In selected cases, this hybrid approach using the ascending aorta for antegrade revascularization of cerebral and visceral arteries is feasible, with acceptable perioperative morbidity. However, its role for the treatment of complex thoracoabdominal aortic disease must be evaluated further.

Fenestrated and branched grafts for para-anastomotic aortic aneurysm repair.

PURPOSE: To investigate the use of fenestration and branch artery stenting during endovascular stent-graft repair of para-anastomotic aneurysms (PAA). METHODS: A retrospective review was conducted of 9 patients (all men; mean age 71 years, range 60-80) who received custom-designed fenestrated endoprostheses for PAA repair. Eight tubular fenestrated devices and 1 composite device (fenestrated tube plus modular bifurcated body) with a total of 31 fenestrations were used. RESULTS: The mean operating time was 318+/-93 minutes (range 220-485); the mean fluoroscopy time was 77+/-38 minutes (range 39-158), during which a mean 121+/-81 mL (range 33-300) of contrast was used. Technical success was achieved in all cases. Over a mean follow-up of 12+/-5.5 months (range 6-24), 1 secondary intervention was carried out due to a break in a side branch stent-graft; 2 transient renal impairments and 1 permanent renal insufficiency unrelated to renal artery patency were observed. So far, no vessel loss has emerged. CONCLUSION: Conventional repair of PAA has been a standard procedure for many years, though it carries high surgical risk as well as perioperative mortality. Fenestrated endografts may be a promising alternative in selected patients.

Branched iliac bifurcation: 6 years experience with endovascular preservation of internal iliac artery flow.

OBJECTIVE: The objective of the current study was to share a 6-year experience with the iliac bifurcation device (IBD) and determine its safety and effectiveness in patients with common iliac artery aneurysms. METHODS: Between 2001 and 2006, 46 patients were prospectively enrolled in a single institution study on the IBD. Indications included unilateral or bilateral common iliac artery aneurysms (CIAA) (combined or not with abdominal aortic aneurysm endovascular repair). The first 26 patients were intended to receive a first generation unibody IBD and the following 20 patients the second generation, modular, IBD. RESULTS: In 33 patients out of 46 attempted (technical success per patient 72%), 35 iliac bifurcated devices (2 patients received bilateral IBD) out of 51 attempted (technical success per vessel 69%), were successfully implanted. The technical success rate (per vessel) was 58% for the first generation device and 85% for the second generation device. Inability to introduce the side branch into the IIA and intraoperative occlusions were the main reasons for technical failure. Among these failures, only two patients required open conversions. The mean +/- SD follow-up (radiological and clinical) of the 33 patients with a total of 35 successful IBD implantations was 26 +/- 17 months (median 24, range 3 to 60). During the follow-up period out of 35 successfully-implanted iliac bifurcation devices, four (11%) hypogastric side branch occlusions occurred, all within the first 12 months. Cumulative IBD side branch patency was 87% at 60 months. Comparing the first with the second generation IBD outcomes, cumulative patency rates at 2 years revealed no statistical difference (P = .774). No endoleak, and particularly no IBD, modular side branch disconnection, no late rupture, or deaths have yet been encountered. CONCLUSIONS: Preservation of pelvic circulation in high risk patients treated for bilateral or unilateral common iliac aneurysms combined or without AAA is feasible and secure exclusively by endovascular repair. New generation iliac bifurcated devices show a favourable intraoperative performance and long-term outcomes.

Tube stent-grafts for infrarenal aortic aneurysm: a matched-paired analysis based on EUROSTAR data.

OBJECTIVE: Tube stent-grafts for treatment of infrarenal aortic aneurysms (AAAs) are a nearly forgotten concept. For focal aortic pathologies tube stent-grafts may be a treatment option. We have performed a retrospective matched-paired analysis of the EUROSTAR registry regarding the outcome of tube vs. bifurcated stent-grafts for AAA. Tapered aortomonoiliac stent-grafts were not the objective of this study. MATERIALS AND METHODS: From July 1997 to June 2006, 7581 patients who underwent an endovascular AAA repair were entered in the EUROSTAR registry by 164 centers. One hundred fifty-three patients were treated with tube stent-grafts. For each of these 153 patients we selected one patient from a bifurcated stent-graft group (BGG-original, 7428 patients) matched according to gender, ASA, age, AAA diameter, and type of anesthesia. Differences in preoperative details between the two study groups were analyzed using chi-square test for discrete variables and Wilcoxon rank-sum test for continuous variables. Multivariate logistic regression analysis was performed on early complications. Midterm outcomes (>30 days) were analyzed by Kaplan-Meier and multivariate Cox proportional hazard model. RESULTS: The duration of the procedure was shorter in the tube stent-graft group (TGG; 102.3 +/- 52.2) than in BGG (128.3 +/- 55.0; p = 0.0002). Type II endoleak was less frequent in TGG (4.0%; mean follow-up, 23.12 +/- 23.9 months) than in BGG (14.3%; mean follow-up, 20.77 +/- 20.0 months; p = 0.0394). Type I endoleaks and migration were distributed equally, without significant differences between the groups. Combined 30-day and late mortality was higher for TGG (p = 0.0346) and was obviously not aneurysm related. CONCLUSIONS: We conclude that after selection of patients, tube stent-grafts for infrarenal aortic repair can be performed with great safety regarding endoleaks and migration. The combined higher 30-day mortality and non-aneurysm-related mortality during follow-up were mainly caused by cardiac failures in our sample.

Double tube stent-grafts for infrarenal aortic aneurysm: a new concept.

PURPOSE: To present the concept of double tube stent-grafts and examine the indications for and results achieved with these devices. METHODS: From January 1, 2000, to December 31, 2005, 759 patients who underwent endovascular repair of infrarenal aortic aneurysms at 2 centers. Of these, 45 (5.9%) patients received a double tube stent-graft; complete operative and follow-up data were available for retrospective analysis in 41 patients (33 men; mean age 73.1+/-8.9 years). Diameters measured before stent-graft implantation and at follow-up (12, 24, 36, and 48 months) with clinical examination, 2-phase computed tomographic angiography, duplex sonography, and biplanar abdominal radiography were tested for significant changes using ANOVA with the Bonferroni-Dunn correction. Late outcomes (clinical success and endoleak) were analyzed by the Kaplan-Meier method. RESULTS: The postoperative complication rate was 12.2%, with 2.4% systemic complications (1 patient with angina pectoris); the early mortality rate was 0%. Mean follow-up was 21.9+/-12.8 months (range 12-61) for the 41 patients. Four (9.8%) patients died during follow-up of cardiac causes (n = 2), lung cancer (n = 1), and bowel ischemia (n = 1). Four (9.8%) endoleaks were observed during follow-up: 1 distal type I, 2 type II, and 1 type III. Maximum aneurysm diameters shrank from 52.0+/-9.5 mm preoperatively to 44.0+/-10.9 mm (p<0.0001) postoperatively at the latest available follow-up. CONCLUSION: Our study supports the use of this double tube technique for repair of appropriate saccular infrarenal aortic aneurysms. The double tube stent-graft method appears safe in terms of endoleaks and migration, so we recommend that it be considered an option of endovascular aortic aneurysm therapy.

Risk-adapted outcome after endovascular aortic aneurysm repair: analysis of anesthesia types based on EUROSTAR data.

PURPOSE: To compare anesthesia techniques in high-risk versus low-risk patients treated with endovascular aortic aneurysm repair (EVAR) with respect to outcomes. METHODS: From July 1997 to August 2004, 5557 patients were enrolled in the EUROSTAR registry by 164 centers. Low-risk and high-risk patients were each divided into 3 groups according to anesthesia used during operation [general (GA), regional (RA), and local (LA)], resulting in 6 groups. Differences in preoperative and operative details among the 3 types of anesthesia were analyzed using a chi-square test for discrete variables and the Kruskal-Wallis test for continuous variables for each risk profile. Multivariate logistic regression analysis was performed on early complications. RESULTS: Intensive care unit (ICU) admission was less frequent for high-LA (1.2% of patients) than high-RA (7.8%, p=0.0071) and high-GA (16.2%, p<0.0001), but high-RA still had a distinct advantage (p<0.0001) over high-GA. Systemic complications were lower both for high-LA (9.0%, p=0.0128) and for high-RA (10.7%, p<0.0001) than for high-GA (18.3%). Early death (< or =30 days) was reduced in high-RA (3.0%) versus high-GA (4.3%, p=0.0286). CONCLUSION: On the basis of the EUROSTAR data, high-risk patients in particular attain important advantages from minimally invasive anesthetic techniques. Mortality, morbidity, hospital stay, and ICU admission are significantly lower for locoregional versus general anesthesia in the EUROSTAR registry. These results should encourage greater use of regional anesthesia in high-risk patients. Local anesthesia seems to be of similar benefit for EVAR in high-risk patients.

Hemangiosarcoma after endovascular aortic aneurysm repair.

PURPOSE: To report a rare case of hemangiosarcoma after endovascular aneurysm repair (EVAR). CASE REPORT: A 50-year-old man with Klinefelter syndrome presented 5 years after EVAR with a mass at the infrarenal aorta outside the stent-graft. Radiomorphologic and clinical signs were misleading because there had been evidence of an inflammatory process for more than a year. The stent-graft with the surrounding aorta was removed and replaced by a conventional tube graft. Systemic chemotherapy followed. The tumor recurred after 12 months, with pulmonary metastases and tumor embolic occlusion of his left femoral artery. Thrombectomy was performed, and a second course of chemotherapy was administered. The patient died 24 months after the conversion procedure. CONCLUSION: Morphological changes of the aneurysm wall seen on computed tomographic scans of EVAR patients may not be incidental or signs of infection; rather, a malignant tumor of the aorta or lymphatic disease, although rare, have to be taken into consideration as well.

Influence of anesthesia type on outcome after endovascular aortic aneurysm repair: an analysis based on EUROSTAR data.

BACKGROUND: Local and regional anesthesia was used in endovascular aortic aneurysm repair (EVAR) shortly after its introduction, and the feasibility has been documented several times. Nevertheless, locoregional anesthesia has not become accepted on a large scale, probably owing to a traditional surgical attitude preferring general anesthesia. This study compared various anesthesia techniques in patients treated with EVAR for infrarenal aortic aneurysms. METHODS: From July 1997 to August 2004, 5557 patients who underwent EVAR repair in 164 centers were enrolled in the EUROSTAR registry. Data were compared among three groups: a general anesthesia group (GA-G) of 3848 patients (69%), a regional anesthesia group (RA-G) of 1399 patients (25%), and the local anesthesia group (LA-G) of 310 patients (6%). Differences in preoperative and operative details among the three study groups were analyzed using the chi(2) test for discrete variables and the Kruskal-Wallis test for continuous variables. Multivariate logistic regression analysis was performed on early complications. RESULTS: The duration of the operation was reduced in the LA-G (115.7 +/- 42.2 minutes) compared with the RA-G (127.6 +/- 52.8 min, P < .0009) and GA-G (133.3 +/- 59.1 minutes, P < .0001). Admission to the intensive care unit was significantly less for LA-G patients (2%) than RA-G (8.3%, P = .0004) and GA-G (16.2%, P < .0001), but RA-G still had a distinct advantage (P < .0001) over GA-G. Hospital stay was significantly shorter in LA-G (3.7 +/- 3.1 days [P < .0001] vs GA-G [P = .007] vs RA-G), but RA-G (5.1 +/- 7.5 days) still had an advantage (P < .0001) vs GA-G (6.2 +/- 8.5 days). In EUROSTAR, systemic complications were significantly lower both for LA-G (6.6%, P = .0015) and RA-G (9.5%, P = .0007) than for GA-G (13.0%). CONCLUSION: The EUROSTAR data indicate that patients appeared to benefit when a locoregional anesthetic technique was used for EVAR. Locoregional techniques should be used more often to enhance the perioperative advantage of EVAR in treating infrarenal aneurysms of the abdominal aorta.

Long-term outcome after Talent endograft implantation for aneurysms of the abdominal aorta: a multicenter retrospective study.

BACKGROUND: The development of newer-generation endografts for the endovascular treatment of abdominal aortic aneurysms has resulted in considerable improvements in clinical performance. However, long-term outcome data are still scarce. To assess long-term clinical and radiographic outcomes after use of the Talent stent graft, a retrospective analysis was performed that was based on 165 patients treated with this endograft in Germany between October 1996 and December 1998. METHODS: Data were collected according to the recommendation of the ad hoc committee for standardized reporting practices in vascular surgery and were evaluated statistically by using univariate and multivariate analyses. RESULTS: A total of 165 patients were treated with a Talent endograft in 9 German centers before December 31, 1998. Most were asymptomatic (94.5%), male (97.6%), and treated with a bifurcated graft (86.7%). Two patients (1.2%) died within 30 days, and 28 (17%) died during the follow-up period. The cause of death was aneurysm rupture in one case. Survival was 95.4% +/- 1.7% at 1 year, 89% +/- 2.6% at 2 years, 78.1% +/- 3.6% at 5 years, and 76.2% +/- 4.1% at 7 years. Patients classified as American Society of Anesthesiologists grade IV had a significantly lower survival rate (24.9%) than those classified as American Society of Anesthesiologists grade II and III (91.9% and 77.3%). During a mean follow-up period of 53.2 +/- 20.1 months (range, 1-84 months), 47 secondary procedures were performed in 31 patients (18.8%). Kaplan-Meier estimates showed a freedom from secondary intervention of 94.7% +/- 1.8%, 81.7% +/- 3.3%, and 77.4% +/- 3.6% at 1, 3, and 7 years, respectively. The reason for secondary treatment was endograft thrombosis in 10 patients (6.1%), persisting primary endoleak in 9 (5.5%), late secondary endoleak in 6 (3.6%), graft migration in 3 (1.8%), aneurysm rupture in 2 (1.2%), and graft infection in 1 (0.6%). Device migration (> or =10 mm) occurred in seven patients (4.2%). Other graft changes, such as graft kinking (n = 4; 2.4%), fracture of metallic stents (n = 2; 1.2%), erosion of the longitudinal bar (n = 2; 1.2%), or modular component separation (n = 1; 0.6%), were rare. Follow-up computed tomographic imaging revealed a decrease of the maximum aneurysm sac diameter (>5 mm) in 106 (64.2%) patients and an increase in 14 (8.5%) patients. The mean aneurysm diameter significantly decreased (P < .001). Of the factors recorded at baseline, only endoleaks showed a significant correlation with the risk of aneurysm increase during follow-up (P < .001). Adverse anatomy (neck diameter >28 mm, neck length <15 mm, and '5 patent aortic branches) did not adversely influence the aneurysm shrinkage rate, the risk for a secondary procedure, or the clinical success rate. A significantly higher rate of clinical success (P < .05) was observed in patients older than 65 years of age. CONCLUSIONS: Implantation of the Talent endograft device is a safe and effective alternative to open surgery for exclusion of abdominal aortic aneurysm. In comparison with first-generation grafts, the device showed superior durability for as long as 5 to 7 years after implantation. Even if prototypes of the Talent device were implanted in this study, the graft was also successfully used in most patients, even in those with adverse anatomy. Because improvements of the endograft have been made to address connecting bar breaks, a lower incidence of graft limb occlusion can be expected in the future.