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.     

Percutaneous repair of aortic aneurysms: a prospective study of suture-mediated closure devices.

PURPOSE: To evaluate prospectively the safety and efficacy of totally percutaneous placement of abdominal and thoracic aortic endografts using the Prostar XL suture-mediated closure system. METHODS: From January 2002 to January 2005, we attempted to insert percutaneously all bifurcated abdominal aortic and thoracic endografts. Consecutive patients (25 men, four women), with mean age 74.9 years (range 44-84), underwent endovascular repair for 20 abdominal aortic aneurysms (AAA) and nine thoracic aortic aneurysms (repeat operation in one case). Endografts used included 21 Zenith (Cook), eight Talent (Medtronic), one AneuRx (Medtronic). For the technique, two Prostar XL 8F were used to close 22-24F access sites and one Prostar XL 10F to close 16F access sites. RESULTS: Procedural success was achieved in 21/29 (72.4%) patients and in 39/47 access sites (83%). Closure of 22-24F access sites with tandem 8F Prostar devices was successful in 23/29 (79.3%) cases. Closure of 16F access sites with 10F Prostar device was successful in 16/18 (88.8%) cases. There were seven peri-procedural failures requiring surgery to repair the femoral artery in three cases. Four access complications healed without intervention. Overall 25/29 (86.2%) patients had complete percutaneous repair. No late complications were detected during follow-up (median 17.5 months). CONCLUSIONS: Percutaneous treatment of patients with AAA and thoracic aneurysms is feasible in most cases, with a very low risk of access-related complication, providing that the operator has sufficient practical experience of this technique.     

Percutaneous closure devices for endovascular repair of infrarenal abdominal aortic aneurysms: a prospective, non-randomized comparative study.

PURPOSE: This study was designed to describe and evaluate our preliminary results with a percutaneous arterial closure device as compared to those obtained with conventional femoral surgical cut down during endovascular repair of abdominal aortic aneurysms (AAA). MATERIAL AND METHODS: Between January 2004 and December 2006, 40 of 86 AAA patients selected for endovascular repair met the criteria for inclusion in this study. Nineteen of these patients (Group A) received a bifurcated endograft placed by direct puncture of the femoral arteries (38 femoral triangles) with closure by a Prostar((R)) percutaneous arterial closure device (Abbott). The other 21 patients (control group B) were managed with a bifurcated endograft placed by conventional open surgery (42 femoral triangles). Data concerning all 40 patients were collected prospectively and analyzed. RESULTS: The technical success rate was 92% (group A) vs 90% (group B), P=0.79. The incidence of perioperative complications was 16% (3/19) in group A and 14% (3/21) in group B (P=0.89). The mean hospital stay was 5.8 days in group A and 7.8 days in group B (P=0.05). The difference in the length of hospitalisation was associated with reduced cost for the percutaneous group (5579.60 euros vs. 7503.60 euros; P=0.04), that counterbalanced the cost induced by the Prostar XL((R)) suture mediated device. Mean follow-up in both groups was 12 months. The overall incidence of locoregional complications after one year of follow-up was 11% (2/19) in group A and 19% (4/21) in group B (P=0.45). CONCLUSION: This study confirms the feasibility and safety of total percutaneous endovascular AAA repair. Our preliminary results suggest that the costs paid by healthcare providers for endovascular AAA repair might not be increased with the selective use of percutaneous closure devices.     

Does endovascular grafting represent a giant step forward?

Endovascular repair of abdominal aortic aneurysms was first reported in 1991 by Parodi et al. Since then, there has been widespread development of many stent-grafts for abdominal aortic aneurysm (AAA) repair. Available data support the proposition that stent-grafts are generally safe, although their long-term efficacy remains completely unknown. Importantly, endovascular AAA repair has neither fewer complications nor lower mortality rates than open repair; in fact, the opposite appears true. Along with most new techniques come new complications, and endovascular repair of AAA has brought forth the concept of both "endoleak" and device failure. Although it is uncommon, delayed AAA rupture after seemingly successful endovascular repair of AAA has been reported. In our opinion, these faults unique to endovascular repair mandate a cautious approach to the clinical application of stent-grafts. Until ongoing phase 2 and future phase 3 studies are completed with a minimum of 2 to 3 years' follow-up, we shall not know whether endovascular repair of AAA represents a giant step forward or merely an industry-driven overuse of proprietary technology.     

完全穿刺技术在腹主动脉瘤腔内修复术中的应用

目的 探讨应用Perclose ProGlide缝合器完全穿刺技术行腹主动脉瘤腔内修复术的安全性和有效性.方法 2008年5月至2010年4月,36例腹主动脉瘤患者完全穿刺下行腔内修复术治疗.其中男性30例,女性6例;平均年龄68岁.所应用的支架型血管包括:3例Endurant,13例Talent,20例Zenith.18～24 F的鞘管预置两把ProGlide,14～16 F的鞘管预置单把ProGlide.缝合动脉切口时取出鞘管并将线结下滑收紧.统计技术成功率、相关并发症及手术操作时间.术后3、6、9、12个月及其后每年进行CT血管造影随访.结果 20例局部麻醉,16例全身麻醉.68条股动脉共应用128把ProGlide,其中38条股动脉各应用2把,8条各应用3把,2条各应用4把,20条各应用1把.63条股动脉(63/68,92.6%)技术操作成功,2条中转切开缝合,3条出现血肿,无需手术处理.平均随访时间(12±3)个月.1例于术后3个月出现无症状的动脉夹层.结论 完全穿刺技术在腹主动脉瘤腔内修复术中的应用是安全和有效的.由于可能需要切开缝合,建议在杂交手术室中操作.     

Endovascular repair of a common iliac artery aneurysm using the Cook Zenith abdominal aortic aneurysm Endovascular Graft Converter

Isolated common iliac artery aneurysm is a rare condition that is treated aggressively because of its high risk of rupture. Endovascular abdominal aortic aneurysm (AAA) repair has recently been extended to the clinical management of the iliac artery aneurysm. Stent grafts have been used successfully to exclude iliac artery aneurysms. Successful graft deployment and aneurysm exclusion require adequate seal and fixation at the proximal and distal attachment sites. This article presents a high-risk surgical patient whose 6.8-cm-diameter iliac artery aneurysm was repaired with a Zenith AAA Endovascular Graft Converter (Cook, Bloomington, Indiana). This device is normally used to convert an aortobiiliac endograft to an aortouniiliac endograft during AAA repair. The tapered 80-mm-long graft has diameters of 24 mm proximally and 12 mm distally. Completion arteriogram demonstrated exclusion of the iliac artery aneurysm with no evidence of endoleak. No postoperative complications occurred. No endoleak was seen on the follow-up abdominal computed tomography scan.     

Surgical complications from hemostatic puncture closure devices

BACKGROUND: For securing immediate hemostasis following percutaneous arterial catheterization, the Food and Drug Administration has approved three hemostatic puncture closure devices. We reviewed our institutional experience with one device (Angio-Seal). METHODS: A retrospective, single-center, nonrandomized observational study was made of all vascular complications following femoral cardiac catheterization. RESULTS: An immediate mechanical failure of the device was experienced in 34 (8%) patients. Surgical repair was required in 1.6% (7 of 425) of patients following Angio-Seal versus 0.3% (5 of 1662) following routine manual compression (P = 0.004). In 5 patients, the device caused either complete occlusion or stenosis of the femoral artery. The polymer anchor embolized in 1 patient and was retrieved with a balloon catheter at surgery. CONCLUSION: During the first year of utilization of a percutaneous hemostatic closure device following cardiac catheterization, we observed a marked increase in arterial occlusive complications requiring surgical repair. Surgeons must be familiar with the design of these devices to achieve precise repair of surgical complications.     

Outcome of symptomatic, unruptured abdominal aortic aneurysms after endovascular repair with the Zenith stent-graft system

OBJECTIVE: Symptomatic abdominal aortic aneurysms (AAA) account for up to 20% of patients with unruptured AAA undergoing open repair. This condition is associated with an average postoperative mortality rate after open repair of about 16%. The aim of this study was to evaluate the outcome of a consecutive series of patients who underwent endovascular repair for symptomatic, unruptured AAA. MATERIAL AND METHODS: From January 2000 to October 2006, 14 patients underwent endovascular repair of intact AAA within 15 days since admission for AAA-related symptoms. In these patients, a Zenith stent-graft (Cook Incorporated, Bloomington, IN, USA) was deployed at the Oulu University Hospital, Kuopio University Hospital and Helsinki University Hospital, Finland. RESULTS: Stent-grafting was not successful in one patient because of access failure. The procedure was immediately converted to open repair and an aortobifemoral bypass with a Dacron prosthesis was performed. In the remaining 13 patients, bifurcated Zenith stent-grafts were deployed. After the procedure, type II endoleak was observed in three patients. The mean follow-up time was 1.9+/-1.4 years. The 2-year survival rate was 69%. The survival freedom from secondary procedure was 71% as one patient underwent stent-grafting for a distal type I endoleak 5 months after the procedure. Another patient underwent femoro-femoral cross-over bypass surgery because of right limb graft thrombosis which occurred 9 months after the procedure. CONCLUSIONS: These preliminary results suggest that endovascular repair of symptomatic, unruptured AAA is feasible and can be associated with a favourable outcome despite a very high operative risk.     

Impact of endograft design and product line on the device cost of endovascular aneurysm repair

OBJECTIVE: Device cost is a substantial component of the overall cost of endovascular abdominal aneurysm repair (EVAR), and the four commercially available devices differ significantly in the cost of their basic configuration. This study examined the impact of three different endografts and their product lines on the overall cost of repair. METHODS: Implant records of 467 EVAR procedures performed during 2000 through 2006 were reviewed. The three devices used were the AneuRx in 178 (38.1%; Medtronic, Santa Rosa, Ca), the Excluder in 123 (26.3%; W. L. Gore & Associates, Flagstaff, Ariz), and the Zenith in 166 (35.5%; the Cook Zenith (Bloomington, Ind). The Powerlink device (Endologix, Irvine, Calif) was not studied. The specific device implanted was determined by its commercial availability at the time of repair, patient anatomy, and surgeon preference. Retail list prices were used for all calculations, and only devices used during the original repair were used for analysis. RESULTS: The device cost of the most basic configuration for repair (ie, 2 pieces for AneuRx and Excluder, 3 pieces for Zenith) differed by $3022 between the most expensive (Zenith) to the least expensive (AneuRx). However, the AneuRx system required the most number of extensions (1.90 +/- 1.25 per case; range, 0-7), whereas the Zenith required the fewest (0.21 +/- 0.51 per case; range, 0-3). When the costs of the extensions were added, the overall mean device costs per case were similar. CONCLUSION: The initial cost advantage of the AneuRx and Excluder endograft systems were offset by the more frequent need for proximal and distal extensions. The minimum device cost of a basic repair should not factor into the decision to select one specific device over another because additional devices may be required depending on the design and construction of the endograft system and the accuracy and reliability of their deployment mechanisms.     

Analysis of renal function after aneurysm repair with a device using suprarenal fixation (Zenith AAA Endovascular Graft) in contrast to open surgical repair

PURPOSE: This study was undertaken to assess the effect on renal function of open surgery and endovascular abdominal aortic aneurysm (AAA) repair with suprarenal fixation with the Zenith device. METHODS: Data for 279 patients with similar preoperative comorbid conditions were prospectively analyzed after AAA repair. One hundred ninety-nine patients underwent endografting with the Zenith AAA Endovascular Graft, which incorporates suprarenal fixation (Zenith standard risk group, ZSR), and 80 patients underwent open surgery (standard surgical risk group, SSR). Endovascular repair was also performed in 100 patients considered poor candidates for open repair (Zenith high risk group, ZHR). Serum creatinine concentration (SCr) and anatomic defects were assessed before the procedure, before discharge, and at 1, 6, 12, and 24 months in all patients who underwent endovascular repair, and before the procedure and at 1 and 12 months in patients who underwent open surgical repair (only SCr was measured before discharge). Renal function was also analyzed, with a creatinine clearance calculation (Cockcraft-Gault). Renal insufficiency was defined as an increase in SCr greater than 30% from a preoperative baseline value, any SCr concentration in excess of 2.0 mg/dL, or any need for dialysis. Cumulative renal infarction and arterial occlusion rates were calculated with computed tomographic, ultrasonographic, and angiographic data, and reported as cumulative values. RESULTS: Despite the initially superior renal function in the ZSR group at the pre-discharge evaluation (P =.01), there were no differences at 12 months with respect to rise in SCr greater than 30% (ZSR, 16%, vs SSR, 12%; P =.67), SCr rise greater than 2.0 mg/dL (ZSR, 2.5%, vs SSR, 3.4%; P =.66), incidence of renal artery occlusion (ZSR, 1%, vs SSR, 1.4%; P >.99), or infarction (ZSR, 1.5%, vs SSR, 1.4%; P >.99). Only one patient in each group required hemodialysis. Of note, both groups of patients demonstrated a reduction in creatinine clearance over 12 months, which then stabilized or improved by 24 months for ZSR patients. CONCLUSIONS: Renal dysfunction occurs in a subset of patients regardless of type of repair (open or endovascular with suprarenal fixation). The cause of renal dysfunction after open or endovascular repair with a suprarenal stent is probably multifactorial. The observed dysfunction occurs in a small number of patients, and the effect in the endovascular group (no data for the surgical group at 24 months) appears to be transient. The initial dysfunction, apparent in both groups over 12 months of follow-up, stabilizes or improves at 12 to 24 months.     

Durability of benefits of endovascular versus conventional abdominal aortic aneurysm repair

PURPOSE: Endovascular abdominal aortic aneurysm (AAA) repair is reported to result in less initial patient morbidity and a shorter hospital length of stay (LOS) when compared with conventional AAA repair. We sought to examine the durability of this result during the intermediate follow-up interval. METHODS: The records of all admissions for all patients who underwent AAA repair during a 26-month interval were reviewed. RESULTS: Three hundred thirty-seven (337) patients underwent procedures to repair AAAs (163 open and 174 endovascular). Endovascular procedures were performed with a variety of devices (Talent, 108; Ancure, 36; AneuRx, 26; Zenith, 2; and Cordis, 2) and configurations (141 bifurcated and 33 aortomonoiliac). The mean follow-up period was 10.6 months (endovascular repair) and 12.3 months (open repair). LOS did not significantly vary by device (P =.24 to P =.92) or configuration (P =.24). The initial median LOS for procedures was significantly shorter (P =.009) for endovascular repairs (5 days) than for open procedures (8 days). However, the patients who underwent endovascular repair were more likely to be readmitted during the follow-up interval when compared with patients who underwent open procedure. The readmission-free survival rate after AAA repair at 12 months was 95% for patients for open AAA repair versus 71% for patients for endovascular repair (P <.001). If the total hospital days were compared, including the initial and all subsequent AAA-related admissions, there was no significant difference for mean LOS for patients who underwent endovascular versus open AAA procedures (11 days versus 13.6 days; P =.21). The patients for endovascular AAA repair most commonly needed readmission for treatment of endoleak (n = 31), wound infection (n = 12), and graft limb thrombosis (n = 9). Although women had similar LOS to men for endovascular repair (P =.44), they had longer initial LOS for open AAA repair (15 versus 10 days; P =.03). After endovascular repair, women were more likely than men to be readmitted by 12 months (51% versus 71% readmission-free survival rate; P =.03) and they had longer LOS on readmission (13.2 versus 5.2 days; P =.006). No gender differences were identified for patients after open AAA repair regarding readmission-free survival rate (P =.09) or LOS on readmission (P =.98). CONCLUSION: Although initial LOS was shorter for the patients who underwent endovascular as compared with conventional AAA repair, this advantage was lost during the follow-up interval because of frequent readmission for the treatment of procedure-related complications, chiefly endoleak. These readmissions frequently involved the performance of additional invasive procedures. Gender differences existed regarding LOS and the likelihood of complications after open and endovascular AAA repair.     

Efficacy of a bifurcated endograft versus open repair of abdominal aortic aneurysms: a reappraisal

OBJECTIVE: Late complications and graft failures have recently cast serious doubts on the durability of endovascular repair of abdominal aortic aneurysms (AAA). The results of a multicenter trial comparing a bifurcated endograft (AB) with standard open repair (OR) were reviewed to assess the late findings of both methods of AAA treatment. PATIENTS AND METHODS: In a multicenter study of AB versus OR conducted from December 1995 to February 1998, 242 patients with AAA successfully treated with an AB and 111 control patients treated concurrently with OR were followed up at least yearly. Twenty-five immediate conversions were excluded from late follow-up. All imaging modalities obtained during follow-up were reviewed by a core laboratory for AAA size, endoleaks, migration, and device integrity. Clinical outcomes at the yearly visits were compared. All death reports were reviewed to classify the cause of death. RESULTS: Average follow-up for the AB group was 36 months, with 194 patients at 3 years and 55 patients at 4 years. The cumulative mortality rate was similar between the AB (15.7%) and OR groups (12.6%; P =.59). The significant early benefit to the AB group in cardiopulmonary complications was no longer evident by 3 years. However, the AB advantage in total and bowel complications, as well as the higher renal complication rates, persisted. At 3 years, 73.7% of patients showed a significant reduction of their AAA size, whereas 25.7% still had an endoleak. One migration and two single hook fractures were noted. Graftrelated reinterventions were performed in 50 patients (20%) without any deaths. Twenty-eight patients (11.6%) underwent interventions for limb flow compromise, whereas 25 were treated for endoleak. Late conversion to OR was required in five patients (2%). No AAA ruptures were encountered in either group. CONCLUSIONS: Rupture-free survival rates after treatment of AAA with the bifurcated AB are similar to those of the OR group. Notably the proximal attachment system is relatively stable and the AAA shrinks in three of four patients treated. Reinterventions are nonetheless required in nearly one of five patients. Although most late procedures are percutaneous, counseling regarding possible future interventions is necessary.     

"Fast-track" abdominal aortic aneurysm repair

The "open" repair of abdominal aortic aneurysm (AAA) continues to evolve with incorporation of less invasive methods for surgical exposure and the use of patient care pathways for shorter hospital stays. In a consecutive series of 30 patients with infrarenal AAA, a "fast-track" hospital care pathway was implemented that included the following: AAA exposure via a limited (10-15 cm) retroperitoneal incision, use of self-retaining retractor and special vascular clamps/instruments, and prosthetic graft endoaneurysmorrhaphy. Excellent anatomic exposure for graft implantation was achieved with an average operative time of 175 minutes. Use of oral metoclopromide and patient-controlled epidural analgesia resulted in patient ambulation and oral diet on postoperative day 1. Average length of hospital stay was 3.6 days (range: 3-7 days), and no patient required readmission for AAA repair-related or gastrointestinal problems. One patient died (30-day mortality rate of 3.3%) caused by delayed recognition of a splenic injury, and 1 patient sustained an intraoperative ureter injury that was repaired and stented. Although stent-graft exclusion for AAA repair has become popular, the major advantages of endovascular therapy, such as shorter ICU and hospital stays, earlier dietary feeding, and reduction in postoperative morbidity, can also be achieved by using minimal incision exposure for AAA interposition grafting combined with traditional hand-sewn vascular anastomoses. "Fast-track" AAA repair is applicable to the majority of patients with infrarenal AAAs, and vascular surgeons can easily master the technique of "limited" incision retroperitoneal exposure. This approach avoids the concerns of endovascular stent-graft durability and the mandatory vascular imaging follow-up to identify endoleak development and AAA enlargement.     

Zenith AAA endovascular graft: intermediate-term results of the US multicenter trial

PURPOSE: The intent of this study was to assess the safety and effectiveness of the Zenith AAA Endovascular Graft compared with conventional aneurysm repair. MATERIAL AND METHODS: The study was conducted in a prospective, multicenter, nonrandomized, concurrent control manner. Physiologically similar patients with infrarenal abdominal aortic aneurysms (AAAs) underwent either open surgery or repair with the Zenith AAA Endovascular Graft. Separate analyses of physiologically challenged patients were performed. Follow-up was conducted at hospital discharge and at 1, 6, and 12 months (endovascular repair group) or 1 and 12 months (open surgical repair group). Evaluation included computed tomography, abdominal radiography, laboratory tests, and physical examination. Mortality (AAA-related and overall), morbidity, in-hospital recovery, renal function, and secondary interventions were assessed. Patients in the endovascular repair group were evaluated for change in aneurysm size, endoleak, graft migration, conversion, rupture, and device integrity. Statistical analyses were performed with the Kaplan-Meier method, Blackwelder test, propensity score assessment, two-sample t test, Yates-corrected Pearson chi(2) test, and Fisher exact test. RESULTS: Conventional open surgery was used in 80 patients, and 200 patients underwent repair with the Zenith AAA Endovascular Graft. Technical success was accomplished in 98.8% of patients in the open repair group and 99.5% in the endovascular repair group. Patients in the endovascular repair group had fewer significant adverse events within 30 days (80% vs 57%; P <.001). All-cause mortality was similar (endovascular, 3.5%; open surgery, 3.8%). Aneurysm-related mortality was higher with conventional surgery at 12 months (3.8% vs 0.5%; P =.04). In-hospital recovery and procedural measures were better for endovascular repair in all categories (P <.001). The incidence of endoleak was 17% at 30 days, 7.4% at 12 months, and 5.4% at 24 months. Aneurysm shrinkage (>5 mm) was noted in more than two thirds of patients at 12 months and three fourths of patients at 24 months. Renal dysfunction rate did not differ between groups. Migration (>5 mm) was detected in four (2%) patients through 12 months; none was greater than 10 mm or associated with adverse events through 24 months. Three conversions were performed within 12 months, one because of aneurysm rupture. Secondary procedures were more common in the endovascular group (11% vs 2.5%; P =.03). In total, 351 patients had endografts implanted, and 6 patients were noted to have barb separations through 12-month follow-up. No stent fractures were noted. CONCLUSIONS: The Zenith AAA Endovascular Graft is safe and effective for treatment of infrarenal AAAs. The high likelihood of decrease in aneurysm size provides evidence that treatment of aneurysms with this device reverses the natural history of aneurysmal disease. The importance of long-term follow-up is underscored by the small but defined incidence of barb separation and the potential for unforeseen failure modes.     

Endovascular stent-graft repair for abdominal aortic aneurysm in a patient with cardiac and renal dysfunction

This case report details our experience with endovascular stent-graft repair for an abdominal aortic aneurysm (AAA) in a patient who was previously treated by left ventricular remodeling for dilated cardiomyopathy. Renal dysfunction with an elevated creatinine level (1.59 mg/dl) was managed by reducing the dose of contrast medium utilizing intravascular ultrasonography. Using a Zenith AAA endovascular device, the aneurysmal sac was successfully excluded and was thrombosed. Endovascular stenting is a good treatment option for abdominal aneurysm repair in patients with poor heart function and renal impairment.     

Iatrogenic vascular injuries from percutaneous vascular suturing devices

OBJECTIVE: The purpose of this study was to examine the patterns of injury and the strategies of surgical repair of iatrogenic vascular injuries from a percutaneous vascular suturing device after arterial cannulation. METHODS: We retrospectively reviewed the clinical experience from an academic vascular surgical practice over a 2-year period. The subjects were patients undergoing vascular repair of iatrogenic vascular injury after deployment of a percutaneous vascular suturing device. Interventions were direct repair of arterial injury (with or without device extraction) or arterial thrombectomy and repair. The main outcome variables included patterns of arterial injury, magnitude of arterial repair, limb salvage, hospital stay, and perioperative mortality and morbidity rates. RESULTS: From August 1998 through August 2000, eight patients (4 men, 4 women; median age, 55 years; range, 44-80 years) required vascular operations for complications of percutaneous suturing devices after diagnostic (2) or therapeutic (6) arteriograms through a transfemoral approach. Complications included four pseudoaneurysms (1 infected) due to arterial tear from suture pull through, two entrapped closure devices due to device malfunction, and two arterial thromboses due to narrowing/severe intimal dissection. All patients required operative intervention. Direct suture repair with or without device removal was performed in five patients, arterial debridement with vein patch angioplasty in one patient, and arterial thrombectomy and vein patch angioplasty in two patients. There were no perioperative deaths. The median hospital stay was 5 days (range, 2-33). Limbs were salvaged in all patients with a mean follow-up of 4.8 months (range, 1-13). CONCLUSIONS: Although abbreviated postangiography recovery periods and early ambulation have motivated the widespread use of percutaneous suturing devices, the infrequent occurrence of vascular injuries produced by these devices can be significantly more challenging than simple acute pseudoaneurysms or hemorrhage. In addition, thrombotic complications have a small but finite risk of limb loss.     

The Zenith AAA endovascular graft for abdominal aortic aneurysms: clinical update

PURPOSE: The aim of this study was to provide an update regarding the US clinical trial assessing the performance of the Zenith AAA Endovascular Graft in the treatment of abdominal aortic aneurysms. MATERIALS AND METHODS: A prospective, nonrandomized, concurrent control-based study design was used to contrast conventional repair of infrarenal aneurysms with endovascular repair in patients that would otherwise be candidates for open surgical procedures. Additional study arms allow high-physiologic-risk patients and roll-in patients to be treated using the same endovascular device in a registry format. Patients were evaluated clinically and radiographically computed tomography (CT) and abdominal radiographs) before any intervention, at hospital discharge, 30 days, 6 months, 12 months, and yearly thereafter. Data were analyzed with the intent of assessing acute and chronic morbidity and mortality, radiographic parameters indicative of successful aneurysm repair, and device integrity. RESULTS: A total of 352 patients were treated with the Zenith graft (one patient did not receive an implant in the standard-risk group), and 80 patients underwent conventional surgical repair. Two hundred patients were enrolled in the standard-risk group, 100 in the high-risk group, and 52 underwent endovascular repair as roll-in patients. All cause mortality, aneurysm-related deaths, and ruptures were statistically identical between the groups. Procedural morbidity was significantly lower for patients treated with endovascular grafts with respect to cardiac, pulmonary, renal, and vascular complications. Secondary interventions were more commonly required in the endovascular group. The endoleak rate was 4.9% at 12 months in the standard-risk endovascular group. There was one rupture in the high-risk subset of patients and 3 elective conversions. A total of 1.6% of the endovascular patients were noted to have a barb separation without evidence of significant migration or clinical events. No other device integrity issues were observed. CONCLUSIONS: The safety of the Zenith endovascular graft was superior to conventional management with respect to morbidity and clinical utility. The short-term device efficacy was satisfactory; however, longer-term follow-up will be necessary to establish the duration of this observation.     

Delayed aorto-right atrial fistula following percutaneous closure of atrial septal defect

We present the case of a 27-year-old man who underwent percutaneous atrial septal defect (ASD) repair using the Amplatzer^® (St Jude Medical, St Paul, MN, US) septal occluder (ASO). Six weeks later, he presented with heart failure and was found to have an aorto-right atrial fistulation. He required urgent surgical device explantation and repair of the existing ASD using a pericardial patch repair technique. This is the first case to be reported from the UK describing a delayed aorto-right atrial fistula following percutaneous closure using ASO.     

Acute and chronic open conversion after endovascular aortic aneurysm repair: a 14-year review

OBJECTIVE: This study reviewed outcomes of patients requiring surgical conversion after endovascular abdominal aortic aneurysm (AAA) repair. METHODS: Records for all patients undergoing open conversion after endovascular AAA repair were reviewed. RESULTS: From 1993 to 2006, 574 patients underwent endovascular repair for AAA. Seventeen patients, including three patients who underwent prior endovascular repair at other centers, required surgical conversion with complete (n = 9) or partial graft removal (n = 8). Five patients required immediate conversion (acute), and 12 underwent delayed conversion 4 to 72 months after endovascular repair. Indications for acute conversion were large type I endoleak (n = 3, 60%), including one patient with graft migration, and retroperitoneal bleeding (n = 2, 40%). Indications for chronic conversion were endoleak with increasing aneurysm size (n = 9, 75%), stent fracture without endoleak (n = 1, 8%), delayed retroperitoneal bleeding (n = 1, 8%), and infection (n = 1, 8%). Suprarenal aortic cross-clamping was required in two patients (12%), and endograft components were retained in eight (47%). An aortic occlusion balloon placed through the body of the existing endograft facilitated proximal control in three patients. There were two perioperative deaths in the acute conversion group (2/5; 40%) and none in the delayed conversion group (P = .04). Five-year actuarial survival was 71.9%. Mean follow-up was 41.6 +/- 32.2 months. Retained endovascular components in patients with partial graft removal remained stable during follow-up. CONCLUSIONS: Surgical conversion after endovascular AAA repair can be performed without suprarenal clamping in most patients. Endovascular aortic control with a balloon avoids suprarenal exposure. Partial endograft removal in selected patients facilitates open conversion and appears durable. Acute conversion is associated with increased mortality.     

The impact of stent-graft development on outcome of AAA repair--a 7-year experience.

OBJECTIVE: to analyse the impact of stent-graft (SG) design and operator skill on the outcome of endovascular AAA repair. DESIGN: prospective non-randomised open. MATERIAL: a total of 158 patients (mean age 71) underwent SG repair. Patients were treated with five different types of SG: first (n =58) and second ( n =17) generation Ivancev-Malm? monoiliac SG (IM I and IM II respectively) combined with femoral-femoral crossover, Chuter bifurcated SG (n =15), Vanguard SG ( n =15) and the Zenith SG ( n =53). METHODS: patients underwent DSA and contrast CT preoperatively and were then followed with CT and digital scans. Recently, one change in AAA diameter and endoleaks (EL) were recorded. Mortality, complications and secondary interventions were recorded and life-table analysis for intervention-free SG survival calculated. RESULTS: immediate and late conversions as well as 30-day mortality were reduced for 2nd (Zenith and Vanguard) compared to 1st generation SG (IM I, Im II and chuter). SG migrations occurred only with the IM I and Chuter SG. Type I EL were significantly more common in 1st generation SG. First generation SG required significantly more secondary interventions than 2nd SG up to 20 months post-operatively. The number of unplanned intraoperative adjunctive manoeuvres was increased with 2nd SG. CONCLUSIONS: enhanced SG design has improved the probability of SG success after endovascular AAA repair. Better technical skills may also have contributed to improved results.