Evan C. Lipsitz

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.

Collected world and single center experience with endovascular treatment of ruptured abdominal aortic aneurysms

Background:Case and single center reports have documented the feasibility and suggested the effectiveness of endovascular aneurysm repair (EVAR) of ruptured abdominal aortic aneurysms (RAAAs), but the role and value of such treatment remain controversial. Objective:To clarify these we examined a collected experience with use of EVAR for RAAA treatment from 49 centers. Methods:Data were obtained by questionnaires from these centers, updated from 13 centers committed to EVAR treatment whenever possible and included treatment details from a single center and information on 1037 patients treated by EVAR and 763 patients treated by open repair (OR). Results:Overall 30-day mortality after EVAR in 1037 patients was 21.2%. Centers performing EVAR for RAAAs whenever possible did so in 28% to 79% (mean 49.1%) of their patients, had a 30-day mortality of 19.7% (range: 0%–32%) for 680 EVAR patients and 36.3% (range: 8%–53%) for 763 OR patients (P < 0.0001). Supraceliac aortic balloon control was obtained in 19.1% ± 12.0% (±SD) of 680 EVAR patients. Abdominal compartment syndrome was treated by some form of decompression in 12.2% ± 8.3% (±SD) of these EVAR patients. Conclusion:These results indicate that EVAR has a lower procedural mortality at 30 days than OR in at least some patients and that EVAR is better than OR for treating RAAA patients provided they have favorable anatomy; adequate skills, facilities, and protocols are available; and optimal strategies, techniques, and adjuncts are employed.

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.

Treatment of ruptured abdominal aneurysms with stent grafts: a new gold standard?

Ruptured abdominal aortoiliac aneurysms, when treated with open surgical repair, have high morbidity and mortality rates. Since 1994, the authors have used endovascular approaches to treat this entity. Patients with presumed ruptured aortoiliac aneurysms were treated with restricted fluid resuscitation (hypotensive hemostasis), transport to the operating room, placement under local anesthesia of a brachial or femoral guide wire into the supraceliac aorta, and arteriography. If aortoiliac anatomy was suitable, an endovascular graft (stent-graft) repair was performed. If the anatomy was unfavorable, standard open repair was performed. Only if circulatory collapse occurred was a supraceliac balloon placed and inflated using the previously positioned guidewire. Of 35 patients treated in this manner, 29 underwent endovascular graft repair, and 6 required open repair. Four patients died within 30 days (operative mortality rate, 11%). Only 10 patients required supraceliac balloon control. Endovascular grafts, when combined with hypotensive hemostasis and other endovascular techniques including proximal balloon control, may improve treatment outcomes with ruptured abdominal aortoiliac aneurysms. The authors believe these techniques will become widely used for the treatment of ruptured aneurysms.

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.

Is elevated creatinine level a contraindication to endovascular aneurysm repair

PURPOSE It is widely believed that chronic renal insufficiency (CRI) greatly increases the risk associated with endovascular abdominal aortic aneurysm repair (EVAR) and is a relative contraindication to the procedure and to the use of intra-arterial contrast agents (IACA). We reviewed a 5-year EVAR experience to determine whether the procedure and use of IACA have an important deleterious effect on renal function in patients with and without pre-existing CRI. METHODS Endovascular aneurysm repair (EVAR) was performed in 200 patients with a variety of endografts, with intra-arterial contrast agents. The patients were retrospectively assigned to three groups on the basis of preoperative serum creatinine concentration (Cr): group 1 (n = 108), Cr less than 1.5 mg/dL (normal range); group 2 (n = 65), Cr 1.5 to 2.0 mg/dL; group 3 (n = 27), Cr 2.1 to 3.5 mg/dL. No patients had undergone hemodialysis. In groups 2 and 3, patients received hydration perioperatively, and received mannitol intraoperatively; no nephrotoxic drugs were administered during the procedure, other than nonionic contrast agent (Omnipaque 350). RESULTS The incidence of postoperative complications between the three study groups was not statistically different. In group 1 a transient increase in serum Cr (>30% over baseline and >1.4 mg/dL) was noted in three patients (2.7%), two of whom (1.9%) required temporary hemodialysis and one (0.9%) who died of renal failure. In group 2 a transient increase in serum Cr was noted in two patients (3.1%); both patients (3.1%) required temporary hemodialysis, and one patient (1.5%) died of renal failure. In group 3 a transient increase in serum Cr was noted in two patients (7.4%); one patient (3.7%) required temporary hemodialysis, and one patient (3.7%) died of renal failure. Perioperative hypotension significantly increased the risk for elevated serum Cr and death (P <.05), and larger contrast volume was associated with an increase in serum Cr (P <.05) during the postoperative period. CONCLUSIONS EVAR with intra-arterial contrast agents can be accomplished in patients with chronic renal insufficiency who do not require dialysis, with limited and acceptable morbidity and mortality, similar to that observed with open aneurysm repair. Contrary to other reports in which perioperative precautions were not used, our study shows that with EVAR the risk for worsening renal failure, dialysis, and death is only slightly, and not significantly, greater in patients with preoperative chronic renal insufficiency compared with patients with normal renal function. Perioperative hypotension and increased contrast volume are significant risk factors for postoperative increase in serum Cr and death. With appropriate precautions such as averting perioperative hypotension and limiting the volume of nonionic contrast agents, elevated Cr need not be a contraindication to EVAR with intra-arterial contrast agents.

Incidence and characteristics of venous thromboembolic disease during pregnancy and the postnatal period: a contemporary series.

BACKGROUND To evaluate the incidence and characteristics of venous thromboembolic events (VTE) associated with pregnancy in a contemporary patient series. METHODS We performed a retrospective review of 33,311 deliveries between June 2003 and June 2008. Patients with objective documentation of a VTE during pregnancy or the 3-month postnatal period were identified from hospital discharge International Classification of Disease Codes edition 9 codes. Diagnosis of deep venous thrombosis (DVT) was largely made by a Duplex ultrasound, whereas pulmonary embolism (PE) was diagnosed by a computerized tomographic angiography (CTA). RESULTS Of 33,311 deliveries during the study period, 74 patients (0.22%) had a VTE. There were 40 incidents of DVT (0.12%) and 37 of PE (0.11%). DVT involved the iliac veins (6), the femoral or popliteal veins (16), the infrapopliteal veins (17), and the axillary vein (1). Most (57.5%) of the DVTs involved the left lower extremity. Thirty-eight (51.6%) of the VTEs occurred in the postnatal period, and of those 33 (87%) occurred within 1 week of delivery. Most of the postnatal VTEs (68%) were seen in patients who underwent a cesarean section. Among patients with VTE during pregnancy, there were 28% in the first trimester, 25% in the second, and 47% in the third. Events were distributed among maternal age groups as follows: 26% aged 13-24, 50% aged 25-34, and 24% aged 35-54. Of the 35 patients tested for a hypercoagulable disorder, 12 were found to have a positive test result. Five (6.8%) of these 74 patients had a prior history of VTE, with two having a hypercoagulable disorder. In addition, 45 of the 74 patients were on oral contraceptive therapy or received hormonal stimulation therapy before pregnancy. Patients with a VTE during pregnancy were treated with low molecular weight or unfractionated heparin. Most postnatal patients were treated with subcutaneous low molecular weight heparin and coumadin. Six inferior vena cava filters were placed in patients with bleeding complications as a result of anticoagulation. There were no deaths during the study period. CONCLUSIONS Comparing our results with historic controls (DVT: 0.04-0.14% and PE: 0.003-0.04%), the incidence of DVT in pregnancy has not changed significantly. We note, however, that the incidence of pulmonary embolus in our series is higher than previously reported. CTA has been used for the diagnosis of PE since the past decade. The increase in the rate of PE in the current series may be because of the higher sensitivity of CTA when compared with previous diagnostic modalities.

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.