Neal S. Cayne

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.

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.

New developments in the preoperative evaluation and perioperative management of coronary artery disease in patients undergoing vascular surgery.

BACKGROUND Preoperative evaluation and perioperative management of cardiac disease in patients undergoing vascular surgery (VS) is important for patients and vascular surgeons. Recent evidence has emerged that has allowed us to develop contemporary paradigms for evaluating and managing coronary artery disease in VS patients perioperatively. METHODS The utility of stress testing, the role of preoperative coronary revascularization, the optimal use of beta-blockers and statins, and the role of antiplatelet therapy in VS patients were reviewed in the literature. RESULTS The revised Lee cardiac risk index, based on the number of risk factors (high-risk surgery, ischemic heart disease, congestive heart failure, cerebrovascular disease, insulin-dependent diabetes mellitus, renal failure, hypertension, and age >75) quantitates cardiac risk. Stress testing is not predictive of myocardial ischemia/infarction (MI) or death and is only recommended in patients with unstable angina or an active arrhythmia. Stress testing for patients with 0 to 2 risk factors delays VS up to 3 weeks. In high-risk patients (>or=3 risk factors), it helps to identify patients who may develop myocardial ischemia and would benefit from a 30-day period to optimize medical therapy before VS. Stress testing and coronary catheterization do not predict which coronary artery to revascularize to prevent MI or death. Revascularization does not decrease MI or death rates at 1 month or 6 years. Although beta-blocker treatment decreases cardiac risk with VS, timing and dosage (titration) influence outcomes, improper usage may increase stroke and death rate, and not all VS patients should be taking these drugs. Patients with >or=1 risk factor should be considered to begin a low dose beta-blocker 1 month before VS. Preoperative statin use sharply decreases MI, stroke, and death perioperatively and long-term postoperatively. CONCLUSION Routine stress testing should not be performed before VS. The Lee index should be used to stratify risk in patients undergoing VS. Patients with >or=3 risk factors or active cardiac conditions should undergo stress testing, if VS can be delayed. All VS patients, except those with 0 risk factors, should be considered for a beta-blocker (bisoprolol, 2.5-5 mg/d started 1 month before VS, titrated to a pulse <70 beats/min and a systolic blood pressure >or=120 mm Hg). Intermediate risk factors may not require aggressive heart rate control but simply maintenance on a low-dose beta-blocker. Statins should be started (ideally 30 days) before all VS using long-acting formulations such as fluvastatin (80 mg/d) for patients unable to take oral medication.

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.

Outcome of carotid artery interventions among female patients, 2004 to 2005.

BACKGROUND The benefit of carotid endarterectomy (CEA) in female patients has been questioned by various randomized, prospective trials, particularly in asymptomatic cases; several have noted an increase in perioperative stroke among women after CEA. The outcome of carotid angioplasty and stenting (CAS) has not been extensively examined in women. This study examined the outcome of CEA and CAS in women vs men by using a national database. METHODS Outcomes of CEA and CAS were stratified by sex using discharge data from the Nationwide Inpatient Sample (NIS), Healthcare Cost and Utilization Project (HCUP), Agency for Healthcare Research and Quality. The NIS was used to identify patient discharges that occurred during 2004 and 2005. Appropriate International Classification of Diseases, 9th Revision (ICD-9) procedure and diagnosis codes were used to identify CEA and CAS cases. Outcome measures included in-hospital perioperative stroke and death. Comparisons of demographics, procedures, and outcome were performed between men and women. Additional analysis was performed among women alone to attempt to identify whether improved outcome was noted with either procedure. RESULTS Of 54,658 procedures, 94.2% were CEA and 5.8% were CAS. Women comprised 42.3% of the analyzed cases. Women and men were equally likely to be symptomatic (5.3% vs 5.3%, P = .8). Women were significantly less likely to undergo CAS than men (5.4% vs 6.1%, P < .001). Women and men had equivalent rates of perioperative stroke when undergoing CEA (1.0% vs 1.0%, P = .9) and CAS (2.7% vs 2.0%, P = .2). Symptomatic women had a significantly higher rate of perioperative stroke overall than did symptomatic men (3.8% vs 2.3%, P = .03). Asymptomatic women had a significantly lower perioperative stroke rate after CEA than after CAS (0.9% vs 2.1%, P < .001). Rates of perioperative showed a trend favoring CEA vs CAS among symptomatic women (3.4% vs 6.2%, P = .1). CONCLUSIONS The concern regarding an increased perioperative stroke rate after CEA among asymptomatic women appears to be unfounded. The perioperative stroke rate among symptomatic women was higher than that of symptomatic men, but still well within the acceptable range for symptomatic patients undergoing a cerebrovascular intervention. Nationally, women underwent CAS significantly less frequently than did men. Outcome among women for perioperative stroke favored CEA over CAS, particularly in asymptomatic patients. CEA may be the preferred treatment in women seeking intervention for cerebrovascular disease, unless compelling reasons exist to perform CAS.

Outcome of endovascular repair of popliteal artery aneurysm using the Viabahn endoprosthesis.

OBJECTIVE This study reviews a single-center experience of endovascular popliteal aneurysm (PAA) repair. METHODS A retrospective review was performed to identify all endovascular PAA repairs performed between September 2004 and January 2011. RESULTS We identified 21 patients (mean age, 74 ± 9 years, 91% men) with PAAs (mean size, 2.89 ± 1.0 cm) in 26 limbs, of which 38% were symptomatic. All patients underwent endovascular repair with a Viabahn covered stent graft (W. L. Gore & Assoc, Inc, Flagstaff, Ariz). Postoperatively, all patients were maintained on antiplatelet therapy with clopidogrel or aspirin, or both. Mean follow-up was 22 ± 17 months (range, 1-57 months). One patient with one aneurysm was lost to follow-up. Primary and secondary patencies were both 91.2% at 1 year and were 85.5% and 91.2%, respectively, at 2 years. The limb salvage rate was 100%. Four stent graft failures occurred at a mean of 12.3 ± 11 months. One technical failure due to stent graft infolding required conversion to an open femoral-popliteal bypass. Three additional graft failures occurred in patients with poor (single-vessel) runoff. Compared with patients with two- or three-vessel runoff, the graft failure rate in patients with single-vessel runoff was statistically significant (P = .02). Two of the graft failures were successfully treated with open thrombectomy, and one required a tibial artery bypass for limb salvage. CONCLUSIONS Endovascular repair of PAAs is feasible and has acceptable midterm patency rates. Poor distal runoff predicted graft failure.

Laser Saphenous Ablations in More Than 1,000 Limbs With Long-Term Duplex Examination Follow-Up

BACKGROUND The goal of this study was to evaluate the duplex results of endovenous laser ablation in the treatment of incompetent great saphenous veins (GSV) and small saphenous veins (SSV) with at least 1-year follow-up. METHODS A retrospective registry was entered by 11 centers from Europe and America, organized by the International Endovenous Laser Working Group. Data concerning 1,020 limbs in patients with incompetence of the GSV and/or SSV, treated with the Endovenous Laser Ablation (EVLA) procedure, were collected. EVLA failures were defined on duplex imaging as reflux confined to the saphenofemoral or saphenopopliteal junction, reflux confined to the main saphenous trunk, or reflux of both junction and main trunk (totally patent saphenous vein) were analyzed at one or more years postoperatively. RESULTS The mean age of patients was 54 ± 5 years (range: 18-91 years). The average body mass index was 25. There was a paucity of severe complications: One case of third-degree skin burn, six patients with postsurgical deep vein thrombosis (0.6%), and 27 cases of sensory nerve damage (2.7%). At 1-year, the rate of complete occlusion of the saphenous trunk was 93.1%. There were 79 cases of treatment failures as evidenced by duplex: 22 isolated junction failures (2.2%), 44 isolated trunk failures (4.4%), and 13 totally patent veins (1.3%). Two-year duplex results were reported for 329 limbs with the identification of 19 new cases of failure. No new cases of failure were reported at 3-year follow-up of 130 limbs. Cumulative failure rates estimated by Kaplan-Meier analysis were 7.7% at 1-year and 13.1% at 2- and 3-year follow-up. CONCLUSIONS On the basis of a duplex scan performed at least 1-year post-treatment, this multicenter registry confirms the safety and efficacy of the EVLA procedure in the treatment of GSV and SSV reflux. Considering the continued failure rate documented in the present study, an annual follow-up by duplex is recommended to 2 years after EVLA.

Technique of supraceliac balloon control of the aorta during endovascular repair of ruptured abdominal aortic aneurysms

Endovascular aneurysm repair is being used increasingly to treat ruptured abdominal aortic aneurysms (RAAAs). Approximately 25% of RAAAs undergo complete circulatory collapse before or during the procedure. Patient survival depends on obtaining and maintaining supraceliac balloon control until the endograft is fully deployed. This is accomplished with a sheath-supported compliant balloon inserted via the groin contralateral to the side to be used for insertion of the endograft main body. After the main body is fully deployed, a second balloon is placed within the endograft, and the first balloon is removed so that extension limbs can be placed in the contralateral side. A third balloon can be placed via the contralateral side and ipsilateral extensions deployed as necessary. This technique of supraceliac balloon control is important to achieving good outcomes with RAAAs. In addition to minimizing blood loss, this technique minimizes visceral ischemia and maintains aortic control until the aneurysm rupture site is fully excluded.

Endovascular solutions to arterial injury due to posterior spine surgery

Iatrogenic arterial injury is an uncommon but recognized complication of posterior spinal surgery. The spectrum of injuries includes vessel perforation leading to hemorrhage, delayed pseudoaneurysm formation, and threatened perforation by screw impingement on arterial vessels. Repair of these injuries traditionally involved open direct vessel repair or graft placement, which can be associated with significant morbidity. We identified five patients with iatrogenic arterial injury during or after posterior spinal surgery between July 2004 and August 2009 and describe their endovascular treatment. Intraoperative arterial bleeding was encountered in two patients during posterior spinal surgery. The posterior wounds were packed, temporarily closed, and the patient was placed supine. In both patients, angiography demonstrated arterial injury necessitating repair. Covered stent grafts were deployed through femoral cutdowns to exclude the areas of injury. In three additional patients, postoperative computed tomography imaging demonstrated pedicle screws abutting/penetrating the thoracic or abdominal aorta. Angiography or intravascular ultrasound imaging, or both, confirmed indention/perforation of the aorta by the screw. Aortic stent graft cuffs were deployed through femoral cutdowns to cover the area of aortic contact before hardware removal. All five patients did well and were discharged home in good condition. Endovascular repair of arterial injuries occurring during posterior spinal procedures is feasible and can offer a safe and less invasive alternative to open repair.