Effect of ethnicity on access and device complications during endovascular aneurysm repair

INTRODUCTION: There are no published reports on the association between ethnicity and outcome after aortoiliac stent grafting to treat aneurismal disease. Because Hawaii is a state with an ethnically diverse population, we conducted a retrospective study to examine this potential association. We hypothesized that individuals of Asian ancestry may have higher complication rates after endovascular repair compared with non-Asians. METHODS: All endovascular devices placed to treat aneurysm disease from 1996 to 2003 were evaluated in two institutions. The association between ethnicity and access-related and device-related complications, both periprocedural and delayed, was examined with logistic regression analysis. RESULTS: Ninety-two aortoiliac endografts were placed during the study period, including 87 in patients with abdominal aortic aneurysms with or without iliac aneurysm disease, and five patients with isolated iliac artery aneurysms. Forty-four percent of patients were categorized as Asian, 39% as white, 16% as Pacific Islander, and 1% as African American. Access-related and device-related complications (ADRCs) occurred in 11 of 92 (12%) of these patients. The following parameters were significantly associated with ADRCs: Asian ethnicity (P =.015), age greater than 80 years (P =.02), and external iliac diameter smaller than 7.5 mm (P =.01). Asian patients were more likely to have experienced ADRCs than were non-Asian patients (odds ratio, 7.3; 95% confidence interval, 1.5-35.8; P =.015). Asians also had smaller external iliac artery diameters (P =.0003) and more tortuous iliac arteries (P =.03) compared with non-Asians. After adjusting for iliac artery diameter and tortuosity, the association between Asian ethnicity and ARDCs became nonsignificant (P =.074), which suggests that the association between race and complications may be at least in part due to small and tortuous iliac arteries. There was no association between age, gender, or ethnicity and postoperative detection of endoleak. CONCLUSION: Our data indicate that individuals of Asian ancestry are far more likely to experience adverse access-related and device-related complications after aortoiliac stent grafting than are non-Asians. We found that this association is at least partly attributable to the smaller and more tortuous iliac arteries in persons of Asian ancestry.     

Canadian experience with percutaneous endovascular aneurysm repair: short-term outcomes

Background

To decrease the morbidity associated with cut-downs during endovascular aneurysm repair, some authors have suggested the totally percutaneous endovascular repair (PEVAR). The goal of this report is to evaluate and describe our centre’s experience with the total percutaneous endovascular aneurysm repair (PEVAR) for aortic abdominal aneurysm (AAA).

Methods

We performed a retrospective analysis of 15 consecutive patients with AAA, including 1 with right common iliac artery aneurysm.

Results

There were 12 men and 3 women with a mean age of 74 (standard deviation [SD] 2) years who underwent PEVAR with a Perclose ProGlide suture-mediated closure system between July 2007 and July 2008. All surgeries were elective. Forty percent of patients had a history of smoking, 73% were hypertensive, 33% were diabetic, 20% had chronic obstructive pulmonary disease and 40% had coronary artery disease. Fourteen patients had bilateral deployment for bifurcated devices (7 bifurcated Gore Excluder, 7 bifurcated Cook Zenith grafts), and 1 patient had unilateral deployment for a Cook Zenith device. The outer diameter of the sheaths used for puncture sites was on average 18.1-Fr (SD 0.6), with main bodies being 21.1-Fr (SD 0.3) and contralateral sides 15-Fr (SD 0.3). Procedural success was 93%, with 1 patient requiring a femoral artery cut-down because of failure of the Perclose device to deploy in the groin. Another patient had persistent venous bleeding in 1 puncture site that stopped with skin suturing. Endovascular aneurysm repair was 100% with no conversion to open surgery and no type-I endoleaks. The mean length of stay in hospital was 2.2 (SD 0.4) days. There were no long-term groin complications at 6 (SD 1) months’ follow-up.

Conclusion

To our knowledge, this is the first Canadian report of experience with PEVAR using the Perclose device. The technique is safe, reliable and allows discharge of patients soon after surgery.     

Open surgical and endovascular conduits for difficult access during endovascular aortic aneurysm repair

Endovascular aortic aneurysm repair has gained widespread acceptance as the primary method of treatment of abdominal and thoracic aortic aneurysms. Difficult access because of small, narrowed, tortuous, or severely calcified iliac and femoral arteries poses a significant challenge and remains a common cause of inadvertent arterial disruption and conversion to open repair. Vascular complications associated with difficult access are associated with major morbidity and mortality. This article summarizes open surgical and endovascular alternatives to dealing with difficult iliofemoral access during endovascular aortic interventions.     

Total percutaneous access for endovascular aortic aneurysm repair ("Preclose" technique)

OBJECTIVE: Percutaneous access during endovascular aneurysm repair has been difficult owing to the large size of the delivery catheters. This study reports a single-center experience of totally percutaneous access during endovascular abdominal and thoracic aortic repairs using the Preclose Proglide device (Abbott Vascular, Redwood City, Calif). METHODS: Between December 2004 and August 2006, 262 endovascular aortic aneurysm repairs were performed. Percutaneous access was used for the introduction of 12F to 24F sheaths (4.4-mm to 8.6-mm outer diameter). The technique involved deployment of two Proglide devices before insertion of the sheath ("Preclose" technique) with the sutures left extracorporeally for closure after conclusion of the procedure. A prospectively maintained endovascular database and medical records were retrospectively reviewed. Rates of technical success, failure modes, and the overall duration of the endovascular repair compared with a similar cohort using open femoral exposures were examined. RESULTS: A total of 559 Proglide devices were used to close 279 femoral arteries, and 175 (63%) required the insertion of 18F to 24F sheaths. There were 16 failures, mainly due to obesity, device malfunction, severe calcific disease, and faulty arterial punctures, for a technical success rate of 94.3%. The success rates for 12F to 16F size sheaths were significantly higher than for the larger 18F to 24F sheaths (99.0% vs 91.4%, P<.01). For both endovascular abdominal (EVAR) and thoracic (TEVAR) aortic repairs, the Preclose technique resulted in shorter overall procedure times compared with a similar cohort in which open femoral exposures were used (EVAR, 115 vs 128 min, P<.001; TEVAR, 80 vs 112, P=.019). Despite this reduction of procedure time, the savings on the cost of operating room time was negated by the cost of the Proglide devices ($295 per device). CONCLUSIONS: Percutaneous access for endovascular aortic repair is safe and feasible using the Proglide device. Although the success rates are higher for smaller size sheaths, successful closures may be obtained for up to 24F sheaths. Percutaneous access may result in shorter overall procedure times and potentially lower operating room costs, but this appears to be offset by the cost of the closure devices.     

Brave new world: the role for endovascular aneurysm repair in contemporary vascular surgery

Endovascular abdominal aortic aneurysm repair (EVAR) poses certain challenges to the vascular surgeon. Based upon our 6-year experience, we have highlighted important aspects of patient selection. EVAR can be performed in patients with significant co-morbidities, but technical success may be limited by anatomic criteria. Short to mid-term outcomes report low mortality and morbidity from EVAR. Acute and delayed conversion, rupture, endoleak, limb occlusion, and migration are complications occurring in EVAR; their frequency, presentation and management are described. EVAR has up to 90% success rate at several years follow-up including the use of secondary procedures. Secondary procedures are not infrequent after EVAR; thus close follow-up is of the utmost importance. We predict that EVAR will continue to be a valuable tool in the future.     

Barriers to endovascular aortic aneurysm repair: past experience and implications for future device development

Despite improvements in endovascular aortic aneurysm repair (EVAR) devices and techniques, significant anatomic constraints still preclude successful EVAR in a large number of patients. The authors sought to identify the current barriers to EVAR and examine their evolution over time. Patients were evaluated for potential endovascular repair by computed tomography angiography (CTA) with or without supplemental conventional arteriograms. The patient population was separated into 2 groups (A and B) based on early and late time periods in the experience with EVAR, corresponding to the availability of various devices. Group A (early) consisted of the Guidant Ancure, Medtronic Talent, and AneuRx devices and comprised patients presenting between April 1997 through June 2000. Group B (late) consisted of the Medtronic AneuRx, Cook Zenith, Edwards Lifepath, Gore Excluder, and Endologix PowerLink devices and comprised patients presenting between July 2000 and December 2003. Patient demographics and anatomic reasons for rejection were recorded in a database for statistical analysis. In total, 547 patients were evaluated (463 men, 84 women). Of these, 346 patients (63%; 312 men, 34 women) were deemed suitable candidates for EVAR and 201 (37%; 151 men, 50 women) were rejected. There was no significant difference in the overall rate of rejection in the early vs the late time period (34% A, 41% B, p = 0.08), but the number of exclusion criteria per patient decreased over time; patients rejected for EVAR had an overall average of 1.6 exclusion criteria (Group A, 1.9; Group B, 1.2). The reasons for rejection did significantly change over time. Specifically, rejection on the basis of inadequate arterial access, presence of extensive iliac artery aneurysms, or an inadequate proximal neck decreased. A disproportionate number of women were excluded throughout the study: Group A, 56% of women compared to 30% of men (p = 0.0003); Group B, 63% of women compared to 36% of men (p = 0.0022). Women were more likely than men to have inadequate arterial access routes. In addition, patients with high operative risk were also more likely to be excluded from EVAR, a finding that persisted over time. Anatomic constraints continue to pose significant challenges to aortic endografting. Progress has been made in that technological advances have conquered some of the previous anatomic challenges, chiefly those of arterial access and treatment of concomitant iliac aneurysm disease. However, the overall rate of rejection for EVAR remains the same. The chief anatomic barriers continue to be the difficult aortic neck and management of branched vascular segments.     

Endotension after endovascular aneurysm repair: the Ancure experience

PURPOSE: The expansion of aneurysms after endovascular repair is a consequence of persistent sac pressure, usually resulting from an endoleak. Several authors have suggested that sac expansion can occur even in the absence of endoleak, referring to this phenomenon as endotension. This study undertakes a review of the largest US endograft trial data to better define the significance of aneurysm expansion in the absence of endoleak. METHODS: The core laboratory imaging database from the Ancure (Guidant) endovascular graft Phase I and Phase II trials approved by the Food and Drug Administration was reviewed with attention to aneurysm size and endoleak. Aneurysm size was measured with standardized two-dimensional computed tomography (CT) scan at the area of largest initial aneurysm diameter. Endoleak was detected with CT scans, color duplex ultrasound scans, and angiography in selected cases. Patients were evaluated at baseline, 3 months, 6 months, 12 months, and every 12 months thereafter. An endograft was classified as leaking if any endoleak was detected with any modality at any time point. RESULTS: A total of 658 patients were entered into these protocols and the data submitted to the core laboratory. A control group of 120 conventional aortic patients and a group of 62 without baseline CT data were excluded from further analysis. Of the remaining 476 patients, 144 (60 tube, 60 bifurcated, and 24 mono-iliac) were free of endoleak at all intervals and had baseline CT measurements to allow comparison. Overall, the average size decrease in this nonleaking group was 9.9 +/- 9.4 mm (range, -50.6-11.1 mm) at a mean follow-up of 23.3 months. Evaluation for overall aneurysm expansion revealed 17 patients who had an increase of 2.3 +/- 2.9 mm (range, 0.3-11.1 mm) at a mean follow-up of 14.1 months. Only two patients without evidence of endoleak exhibited growth of more than 5 mm at maximum follow-up (7.6 mm at 12 months and 11.1 mm at 36 months). Additional analysis of sealed endoleaks and late endoleaks failed to demonstrate any group with expansion in the absence of detectable endoleak. CONCLUSIONS: Endotension appears to be rare in this large series of prospectively evaluated endografts. From this review, endotension seems more likely to represent missed endoleak than true aneurysm expansion in the absence of perigraft flow.     

The multicenter experience with a third-generation endovascular device for abdominal aortic aneurysm repair. A report from the EUROSTAR database

AIM: The purpose of this study was to evaluate the effect of the preoperative diameter of abdominal aortic aneurysms (AAA) upon the midterm outcome obtained by endovascular AAA repair, using a third-generation endovascular device, the Excluder bifurcated endoprosthesis (W. L. Gore & Associates, Inc. Sunnyvale, CA, USA). METHODS: The data of 676 patients, who had undergone endovascular aneurysm repair (EVAR) were analysed. Patients were enrolled over a 6-year period to April 2004 in the EUROSTAR database. Outcomes were compared between 2 groups defined by the preoperative diameter of the aneurysm: group A (n=300), smaller than 5.5 cm; group B (n=376), 5.5 cm or larger. Patient characteristics, details of aorto-iliac anatomy, operative procedure and postoperative complications in the 2 patient groups were compared. Outcome events included aneurysm-related death, overall death, conversion, and late rupture of the aneurysm. Life table analyses and log rank tests were used to compare outcome in the study groups. Multivariate Cox models were used to determine whether baseline and follow-up variables were independently associated with adverse outcomes. RESULTS: Patients in group B were significantly older than patients in group A (73 years vs 71 years respectively; p=0.006), and more frequently were at higher operative risk (ASA-classification >3; 44% vs 59%; p<0.0001). Anatomic differences included a higher incidence of aorto-iliac angulation, a wider and shorter infrarenal neck in group B. Risk factors that were more frequently observed in group B included hypertension, carotid disease and pulmonary disorders. Additional operative events including device migration occurred more frequently in group B (0% vs 2%; p=0.03). Device-related (type I and III combined) endoleaks were more frequently observed at completion arteriography in group B compared to group A (2% vs 4%; p=n.s.). Thirty-day mortality was comparable between the 2 study groups. However, the overall death rate after 3 years of follow-up was significantly higher in patients with larger aneurysms, group B (4% vs 14%; p=0.0025). Similarly, aneurysm-related death was significantly higher in group B (after 3 years 0.3% vs 3%; p=0.02). Aneurysm growth after EVAR was modest low in both study groups (after 2 years 6% vs 8%; non-significant). There was no correlation between growth of the sac and aneurysm-related death. CONCLUSIONS: The midterm outcome after endovascular repair by Excluder devices was satisfactory in patients with small and large AAAs. A higher rate in all-cause deaths and aneurysm-related deaths in patients with larger aneurysms was observed. Post-EVAR aneurysm growth was observed in a small percentage of patients but this did not contribute to aneurysm-related death.     

ExoSeal血管封堵器在股总动脉顺行入路腔内治疗中的应用

目的探讨ExoSeal血管封堵器在股总动脉顺行入路行下肢动脉腔内再通术治疗中的安全性及临床应用价值。方法回顾性分析303例(316条患肢)接受顺行下肢动脉再通治疗患者的临床及影像资料,其中127例患者接受ExoSeal血管封堵器对股动脉穿刺点止血(血管封堵器组),176例患者接受传统压迫止血(手工压迫组)。记录并比较2组止血时间、实际制动时间、技术成功率及血管相关并发症。结果血管封堵器组与手工压迫组的止血时间分别为(3.68±2.40)min和(18.32±4.54)min,实际制动时间分别为(3.45±5.30)h和(10.44±14.68)h,技术成功率分别为98.52%(133/135)和93.92%(170/181),并发症发生率分别为2.22%(3/135)和8.84%(16/181),2组比较差异均有统计学意义(P均0.05)。血管封堵器组发生皮下血肿2例,腹膜后血肿1例;手工压迫组发生皮下血肿15例,穿刺侧肢体急性血栓形成1例。结论采用ExoSeal血管封堵器在股动脉顺行腔内治疗中对股动脉穿刺点止血是一种安全、有效的方法。     

腔内隔绝术治疗主动脉瘤的初步经验

目的 探讨腔内隔绝术(EVAR)治疗主动脉瘤的方法、手术适应证,并评价其治疗效果.方法 回顾性分析2003年3月～2008年3月行EVAR术治疗65例主动脉瘤患者的临床资料;其中主动脉夹层动脉瘤33例(stanfnrd B),胸主动脉瘤4例,肾下腹主动脉瘤28例.结果 65例动脉瘤EVAR手术均获得成功,33例夹层动脉瘤的假腔在术后造影立刻消失,28例腹主动脉瘤及4例胸主动脉瘤瘤体成功隔绝.随访3～24个月,1例患者术后2个月死亡,其余患者未发现支架移位或内漏.结论 动脉瘤的EVAR术治疗具有创伤小、操作可行及效果确切等优点,早期疗效满意,但远期疗效有待于临床进一步观察.严格选择手术适应证是手术成功的关键.     

Use of StarClose for brachial artery closure after percutaneous endovascular interventions

The objective of this study was to evaluate a percutaneous extravascular closure device (StarClose, Abbott Vascular, Redwood City, CA) after brachial endovascular approach. From 2004 to 2006, 29 patients received StarClose for brachial closure. Primary endpoints were successful deployment and absence of procedure-related morbidity, secondary endpoints were brachial artery patency on duplex and absence of late (> 30 days) complications. The device was successfully deployed in all patients. In two patients (6.8%) local complications occurred: one patient developed a large hematoma successfully treated with prolonged compression and a second patient presented with brachial artery occlusion requiring operative intervention. After a mean follow-up of 7.5+/-7.2 months, all patients had a palpable brachial/radial pulse; none had signs of infection, distal embolization or neurological deficits. On ultrasound b-mode imaging, the clip was visible as a 4 mm echolucent area at the outer anterior wall of the artery. Based on the peak systolic velocity ratios between the site of StarClose and proximal brachial artery (mean 1.08+/-0.2), none of the studied patients had a significant stenosis at the site of closure. StarClose is safe and effective in providing hemostasis following interventional procedures through the brachial artery; further advantages include patients comfort and early discharge.