Reese A. Wain

Increasing Incidence of Midterm and Long-Term Complications After Endovascular Graft Repair of Abdominal Aortic Aneurysms: A Note of Caution Based on a 9-Year Experience

ObjectiveTo analyze the late complications after endovascular graft repair of elective abdominal aortic aneurysms (AAAs) at the authors’ institution since November 1992. Summary Background DataRecently, the use of endovascular grafts for the treatment of AAAs has increased dramatically. However, there is little midterm or long-term proof of their efficacy. MethodsDuring the past 9 years, 239 endovascular graft repairs were performed for nonruptured AAAs, many (86%) in high-risk patients or in those with complex anatomy. The grafts used were Montefiore (n = 97), Ancure/EVT (n = 14), Vanguard (n = 16), Talent (n = 47), Excluder (n = 20), AneuRx (n = 29), and Zenith (n = 16). All but the AneuRx and Ancure repairs were performed as part of a U.S. phase 1 or phase 2 clinical trial under a Food and Drug Administration investigational device exemption. Procedural outcomes and follow-up results were prospectively recorded. ResultsThe major complication and death rates within 30 days of endovascular graft repair were 17.6% and 8.5%, respectively. The technical success rate with complete AAA exclusion was 88.7%. During follow-up to 75 months (mean ± standard deviation, 15.7 ± 6.3 months), 53 patients (22%) died of unrelated causes. Two AAAs treated with endovascular grafts ruptured and were surgically repaired, with one death. Other late complications included type 1 endoleak (n = 7), aortoduodenal fistula (n = 2), graft thrombosis/stenosis (n = 7), limb separation or fabric tear with a subsequent type 3 endoleak (n = 1), and a persistent type 2 endoleak (n = 13). Secondary intervention or surgery was required in 23 patients (10%). These included deployment of a second graft (n = 4), open AAA repair (n = 5), coil embolization (n = 6), extraanatomic bypass (n = 4), and stent placement (n = 3). ConclusionWith longer follow-up, complications occurred with increasing frequency. Although most could be managed with some form of endovascular reintervention, some complications resulted in a high death rate. Although endovascular graft repair is less invasive and sometimes effective in the long term, it is often not a definitive procedure. These findings mandate long-term surveillance and prospective studies to prove the effectiveness of endovascular graft repair.

Ex vivo human carotid artery bifurcation stenting: Correlation of lesion characteristics with embolic potential

PURPOSE To develop an ex vivo human carotid artery stenting model that can be used for the quantitative analysis of risk for embolization associated with balloon angioplasty and stenting and to correlate this risk with lesion characteristics to define lesions suitable for balloon angioplasty and stenting. METHODS Specimens of carotid plaque (n = 24) were obtained circumferentially intact from patients undergoing standard carotid endarterectomy. Carotid lesions were prospectively characterized on the basis of angiographic and duplex findings before endarterectomy and clinical findings. Specimens were encased in a polytetrafluoroethylene wrap and mounted in a flow chamber that allowed access for endovascular procedures and observations. Balloon angioplasty and stenting were performed under fluoroscopic guidance with either a Palmaz stent or a Wallstent endoprosthesis. Ex vivo angiograms were obtained before and after intervention. Effluent from each specimen was filtered for released embolic particles, which were microscopically examined, counted, and correlated with various plaque characteristics by means of multivariate analysis. RESULTS Balloon angioplasty and stenting produced embolic particles that consisted of atherosclerotic debris, organized thrombus, and calcified material. The number of embolic particles detected after balloon angioplasty and stenting was not related to preoperative symptoms, sex, plaque ulceration or calcification, or artery size. However, echolucent plaques generated a higher number of particles compared with echogenic plaques (p < 0.01). In addition, increased lesion stenosis also significantly correlated with the total number of particles produced by balloon angioplasty and stenting (r = 0.55). Multivariate analysis revealed that these two characteristics were independent risk factors. CONCLUSIONS Echolucent plaques and plaques with stenosis > or = 90% produced a higher number of embolic particles and therefore may be less suitable for balloon angioplasty and stenting. This ex vivo model can be used to identify high-risk lesions for balloon angioplasty and stenting and can aid in the evaluation of new devices being considered for carotid balloon angioplasty and stenting.

Endoleaks after endovascular graft treatment of aortic aneurysms: Classification, risk factors, and outcome

PURPOSE Incomplete endovascular graft exclusion of an abdominal aortic aneurysm results in an endoleak. To better understand the pathogenesis, significance, and fate of endoleaks, we analyzed our experience with endovascular aneurysm repair. METHODS Between November 1992 and May 1997, 47 aneurysms were treated. In a phase I study, patients received either an endovascular aortoaortic graft (11) or an aortoiliac, femorofemoral graft (8). In phase II, procedures and grafts were modified to include aortofemoral, femorofemoral grafts (28) that were inserted with juxtarenal proximal stents, sutured endovascular distal anastomoses within the femoral artery, and hypogastric artery coil embolization. Endoleaks were detected by arteriogram, computed tomographic scan, or duplex ultrasound. Classification systems to describe anatomic, chronologic, and physiologic endoleak features were developed, and aortic characteristics were correlated with endoleak incidence. RESULTS Endoleaks were discovered in 11 phase I patients (58%) and only six phase II patients (21%; p < 0.05). Aneurysm neck lengths 2 cm or less increased the incidence of endoleaks (p < 0.05). Although not significant, aneurysms with patent side branches or severe neck calcification had a higher rate of endoleaks than those without these features (47% vs 29% and 57% vs 33%, respectively), and patients with iliac artery occlusive disease had a lower rate of endoleaks than those without occlusive disease (18% vs 42%). Endoleak classifications revealed that most endoleaks were immediate, without outflow, and persistent (71% each), proximal (59%), and had aortic inflow (88%). One patient with a persistent endoleak had aneurysm rupture and died. CONCLUSIONS Endoleaks complicate a significant number of endovascular abdominal aortic aneurysm repairs and may permit aneurysm growth and rupture. The type of graft used, the technique of graft insertion, and aortic anatomic features all affect the rate of endoleaks. Anatomic, chronologic, and physiologic classifications can facilitate endoleak reporting and improve understanding of their pathogenesis, significance, and fate.

Endovascular graft repair of ruptured aortoiliac aneurysms.

BACKGROUND The feasibility of endovascular graft (EVG) repair of ruptured aortoiliac aneurysms (AIAs) has yet to be demonstrated. There are inherent limitations in EVG repair, including the need for preoperative measurements of the aneurysmal and adjacent arterial anatomy to determine the appropriate size and type of graft and the inherent delay to obtain proximal occlusion. We developed an EVG system with broad versatility that largely eliminates these problems. STUDY DESIGN Between 1993 and 1998, within an experience of 134 endovascular AIA repairs, 12 ruptured AIAs were treated using EVGs that facilitated intraoperative customization and eliminated the need for preoperative measurements. The EVGs consisted of either a Palmaz stent and a PTFE graft deployed by a compliant balloon (n = 9) or a self-expanding covered stent graft (n = 3). Both grafts were cut to the appropriate length intraoperatively. The mean age of the patients was 72 years (range 40 to 86 years). The mean size of the aneurysms was 7.6 cm (range 3 to 16 cm). Preoperative symptoms were present in all patients and included abdominal or back pain (n = 9), syncope (n = 4), and external bleeding (n = 2). All patients were high surgical risks because of comorbid disease (n = 10) or previous abdominal operations (n = 6), and nine experienced hypotension. RESULTS All EVGs were inserted successfully and excluded the aneurysms from the circulation. The mean operating time was 263 minutes, the mean blood loss was 715 mL, and the mean length of hospital stay was 6.5 days. There were two deaths (16%), one from the preexisting acute myocardial infarction and one from multiple organ failure. There were three minor complications (25%). Two patients required evacuation of an intraabdominal hematoma from the initial rupture. All but one of the grafts was functioning at a mean followup of 18 months. CONCLUSIONS This study demonstrates the feasibility of EVG repair for ruptured AIAs using a graft that can be customized intraoperatively for each patient. Such repairs currently are valuable in patients with ruptured AIAs and serious comorbidities and may be applicable in other circumstances as well.

Can duplex scan arterial mapping replace contrast arteriography as the test of choice before infrainguinal revascularization

PURPOSE Arteriography is the diagnostic test of choice before lower extremity revascularization, because it is a means of pinpointing stenotic or occluded arteries and defining optimal sites for the origin and termination of bypass grafts. We evaluated whether a duplex ultrasound scan, used as an alternative to arteriography, could be used as a means of accurately predicting the proximal and distal anastomotic sites in patients requiring peripheral bypass grafts and, therefore, replace standard preoperative arteriography. METHODS Forty-one patients who required infrainguinal bypass grafts underwent preoperative duplex arterial mapping (DAM). Based on these studies, an observer blinded to the operation performed predicted what operation the patient required and the best site for the proximal and distal anastomoses. These predictions were compared with the actual anastomotic sites chosen by the surgeon. RESULTS Whether a femoropopliteal or an infrapopliteal bypass graft was required was predicted correctly by means of DAM in 37 patients (90%). In addition, both anastomotic sites in 18 of 20 patients (90%) who had femoropopliteal bypass grafts and 5 of 21 patients (24%) who had infrapopliteal procedures were correctly predicted by means of DAM. CONCLUSION DAM is a reliable means of predicting whether patients will require femoropopliteal or infrapopliteal bypass grafts, and, when a patient requires a femoropopliteal bypass graft, the actual location of both anastomoses can also be accurately predicted. Therefore, DAM appears able to replace conventional preoperative arteriography in most patients found to require femoropopliteal reconstruction. Patients who are predicted by means of DAM to require crural or pedal bypass grafts should still undergo preoperative contrast studies to confirm these results and to more precisely locate the anastomotic sites.

Midterm experience with the endovascular treatment of isolated iliac aneurysms

PURPOSE This report describes our 5-year experience with the endovascular repair of isolated iliac aneurysms and pseudoaneurysms. METHODS Between June 1993 and July 1998, 40 isolated iliac aneurysms and pseudoaneurysms were treated with endovascular grafts in 39 patients. Thirty-seven aneurysms were treated with endovascular grafts composed of polytetrafluoroethylene grafts and balloon expandable stents, and the other three underwent repair with a polycarbonate urethane endoluminal graft. RESULTS All the patients underwent initially successful endovascular treatment of isolated iliac aneurysms and pseudoaneurysms and were followed from 1 to 51 months (mean, 18 months). The 4-year primary patency rate was 94.5% +/- 10%. The perioperative complications included one episode of distal embolization, an episode of colonic ischemia, five episodes of kinking or compression of the endovascular graft, and one early postoperative graft thrombosis. There was only one perioperative death in a patient whose aneurysm ruptured in the operating room just before endovascular repair. The median postoperative length of hospital stay was 3.0 +/- 1.3 days in this group of patients at moderate and high risk. The long-term complications included one graft thrombosis and two endoleaks. One small endoleak was followed until the patient died of unrelated causes, and the other one led to aneurysm rupture in the only patient temporarily lost to follow-up examination. This patient successfully underwent treatment in the standard open surgical fashion. To date, all the other aneurysms have remained stable or have decreased in size during the follow-up examinations with duplex or contrast-enhanced computed tomographic scans. CONCLUSION Endovascular repair of iliac aneurysms and pseudoaneurysms is a safe and effective technique with good midterm results in patients at standard and high risk. These grafts are particularly beneficial for patients with medical, surgical, or anatomic contraindications for open surgical repair.

Does transrenal fixation of aortic endografts impair renal function

OBJECTIVES Transrenal fixation (TFX) of aortic endografts is thought to increase the risk for renal infarction and impaired renal function. We studied the late effects of TFX on renal function and perfusion. METHODS Of 189 patients with commercial aortic endografts, which we inserted between 1995 and 2002, we reviewed data for 130 patients (112 men, 18 women) with available creatinine (Cr) concentration and contrast enhanced computed tomography (CT) scans preoperatively and 1 to 97 months after the procedure. Of the 130 patients, 69 patients had TFX and 61 patients had infrarenal fixation (IFX). Both groups were physiologically comparable. Average age was 76 +/- 8 years for patients with TFX and 75 +/- 8 years for patients with IFX. Presence of renal infarct or renal artery occlusion was determined by nephrograms on serial contrast-enhanced CT scans. RESULTS Mean follow-up was 17 +/- 16 months (range, 1-54 months) for TFX and 21 +/- 21 months (range, 1-97 months) for IFX. Mean serum Cr concentration increased significantly during long-term follow-up in both groups (TFX, 1.3 +/- 0.5 mg/dL to 1.5 +/- 0.8 mg/dL, P <.01; IFX, 1.3 +/- 0.7 mg/dL to 1.4 +/- 0.8 mg/dL, P <.03). Creatinine clearance (CrCl) similarly decreased over long-term follow-up in both groups (TFX, 53.3 +/- 17.7 mL/min/1.73 m(2) to 47.9 +/- 16.2 mL/min/1.73 m(2), P <.01; IFX, 58.1 +/- 22.7 mL/min/1.73 m(2) to 53.1 +/- 23.4 mL/min/1.73 m(2), P <.02). There were no significant differences in the increase in Cr concentration (P =.19) or decrease in CrCl (P =.68) between TFX and IFX groups. Small renal infarcts were noted in four patients (5.8%) in the TFX group and one patient (1.6%) in the IFX group. No increase in Cr concentration or decrease in CrCl was noted in any patient with a renal infarct. Postoperative renal dysfunction developed in 7 of 69 patients (10.1%) in the TFX group and 7 of 61 patients (11.5%) in the IFX group. There were no statistically significant differences between groups with respect to number of patients with new renal infarcts (P =.37) or postoperative renal dysfunction (P =.81). CONCLUSION There is a slight increase in serum Cr concentration and decrease in CrCl after aortic endografting. However, there was no significant difference in these changes between patients with TFX and IFX. Although TFX may produce a higher incidence of small renal infarcts, these do not impair renal function. Thus our midterm results suggest that TFX can be performed safely, with no greater change in renal function than observed after IFX.

Fate of collateral vessels following subintimal angioplasty

Purpose: To evaluate the fate of collateral vessels adjacent to and within the target lesion following subintimal angioplasty (SIA). Methods: Pre and postprocedural angiograms were reviewed for 29 patients undergoing SIA of the lower extremity arteries over a 3-year period. The number of patent collateral vessels ≤5 cm proximal to the occlusion (proximal segment) and ≤5 cm distal to the occlusion (distal segment) were recorded pre and postprocedurally and compared. In addition, the number of collateral vessels that were re-opened within the recanalized segment following SIA was counted. Results: The mean number of patent collaterals in the proximal segment was 1.9 (range 0–4) preprocedurally and 1.4 (range 0–4) postprocedurally (p<0.002). The mean number of patent collaterals in the distal segment was 1.9 (range 0–4) pre-procedurally and 1.0 (range 0–4) postprocedurally (p<0.0001). Previously absent collaterals within the recanalized segment were observed in 4 (14%) of 29 patients post-SIA. The mean number of collateral vessels within all 3 segments (proximal, treated, and distal) was 3.9 collaterals preprocedurally and 2.9 collaterals postprocedurally Conclusions: Some collateral vessels are sacrificed during SIA, but the majority are preserved. In addition, SIA has the potential to open new collaterals within the occluded segment. These collaterals may play an important role should restenosis develop within the target segment.

Angiographic criteria reliably predict when carotid endarterectomy can be safely performed without a shunt

BACKGROUND Selective shunting during carotid endarterectomy is widely performed, but the optimal approach for predicting when a shunt is unnecessary remains uncertain. We evaluated the ability of preoperative cerebral angiography to predict when carotid endarterectomy could be safely performed without a shunt. STUDY DESIGN Eighty-seven patients undergoing carotid endarterectomy between August 1991 and December 1997 had preoperative cerebral angiograms. The angiograms were evaluated for the presence of collateral flow from the contralateral carotid through the anterior communicating artery and from the posterior circulation through the posterior communicating artery. Patients then underwent endarterectomy and were selectively shunted based on somatosensory evoked potential changes. Internal carotid artery stump pressure was routinely measured in all patients. RESULTS Nine patients (10%) had a shunt placed based on somatosensory evoked potential changes and none of the 87 patients had a perioperative (30 days) stroke. Angiography revealed that 36 patients (41%) had no cross-filling from the contralateral carotid through the anterior communicating artery. Nine of these patients (25%) required a shunt; none of the 51 patients with adequate cross-filling (p < 0.001) did. Furthermore, 94% of the patients without cross-filling but with a patent ipsilateral posterior communicating artery did not require a shunt using somatosensory evoked potential changes as the standard for shunt insertion. Stump pressure measurements (> or = 25 mmHg) or (> or = 50 mmHg) did not reliably exclude the need for a shunt. Only 2 of 15 patients with contralateral carotid occlusion and 1 of 16 patients with a prior ipsilateral stroke required shunts. CONCLUSIONS In the presence of cross-filling from the contralateral carotid artery, shunt insertion was uniformly unnecessary. In addition, routine shunting of patients with previous ipsilateral strokes or contralateral carotid occlusion was not always necessary. Stump pressures were less sensitive than angiographic criteria in determining when a shunt was unnecessary. Evaluation of cross-filling from the contralateral carotid artery on preoperative angiography can predict with certainty which patients will not require a shunt.

Open aneurysm repair at an endovascular center: value of a modified retroperitoneal approach in patients at high risk with difficult aneurysms.

OBJECTIVE This study was undertaken to evaluate elective open abdominal aortic aneurysm (AAA) repair and the role of a modified retroperitoneal approach in a high-volume endovascular center. METHODS We reviewed prospectively collected data for 175 elective infrarenal open AAA repairs performed over 6 years. A transperitoneal approach was used in 118 procedures, and a modified retroperitoneal approach was used in 57 procedures. The incisional modification, which facilitated repair in patients with massive obesity, scarring, or ventral hernia, included a higher, more posterolateral location in the ninth intercostal space. Risk factors that added to the difficulty of the repair included aneurysms with a short (<1 cm) or no aortic neck in 45 patients; large, angled or flared aortic neck in 32 patients;, tortuous and calcified iliac arteries in 6 patients; morbid obesity in 10 patients; low ejection fraction (15%-30%) in 14 patients; chronic obstructive pulmonary disease, with forced expiratory volume at 1 second less than 55% in 4 patients; previous laparotomy in 18 patients; previous left-sided colectomy in 11 patients; large right iliac aneurysm in 8 patients; large ventral hernia in 8 patients; pelvic irradiation in 4 patients; failed endovascular repair in 5 patients; and previous failed open repair attempt in 2 patients. Many of these factors occurred with significantly greater frequency (P =.04-.001) in the retroperitoneal group. All factors were correlated with outcome. RESULTS Despite these risk factors, overall 30-day mortality was 3.5% (retroperitoneal group, 3.8%), and mean length of hospital stay was 9 days (retroperitoneal group, 8 days). There was no significant correlation between mortality or length of stay and any of the mentioned risk factors (P >.2). CONCLUSION In the era of endovascular aneurysm exclusion, open AAA repair is generally used to treat anatomically complex or difficult aneurysms, many of which are present in patients at high risk. Despite this combination of anatomic and systemic risk factors, the modified retroperitoneal approach facilitates treatment in difficult circumstances and enables open AAA repair to be performed with acceptable mortality and morbidity.