Editor's Choice - Renal complications after EVAR with suprarenal versus infrarenal fixation among all users and routine users.

BACKGROUND: Previous studies comparing endografts with suprarenal and infrarenal fixation for endovascular abdominal aortic aneurysm repair (EVAR) have found conflicting results and did not account for differences in patient selection. This study aims to evaluate the differences in outcomes among surgeons who routinely use either suprarenal or infrarenal fixation, as well as all surgeons in the Vascular Study Group of New England (VSGNE). METHODS: All patients undergoing EVAR in the VSGNE from 2003 to 2014 were identified. All ruptured aneurysms, repairs with concomitant procedures, and infrequently used stent grafts (<50) were excluded. Suprarenal endografts included Talent, Zenith, and Endurant; infrarenal endografts included AneuRx and Excluder. Grafts were compared among surgeons who used only one type of endograft (suprarenal or infrarenal) for >80% of cases, as well as all surgeons. Multivariate regression and Cox hazard models were utilised to account for patient demographics, comorbidities, operative differences, and procedure year. RESULTS: This study identified 2574 patients (suprarenal, 1264; infrarenal, 1310) with 888 endografts placed by routine users (suprarenal, 409; infrarenal, 479). There were no differences in baseline comorbidities, including the estimated glomerular filtration rate, between suprarenal and infrarenal fixation, or between patients with endografts placed by routine and non-routine users. Patients treated with suprarenal endografts received more contrast than all users (102 mL vs. 100 mL, p = .01) and routine users (110 mL vs. 88 mL, p < .01), but other vascular and operative details were similar. Among all users, patients treated with suprarenal grafts had higher rates of creatinine increase >.5 mg/dL (3.7% vs. 2.0%, p = .01), length of stay >2 days (27% vs. 19%, p < .01), and discharge to a skilled nursing facility (9.2% vs. 6.7%, p = .02). There were no differences in 30 day or 1 year mortality. Following adjustment, suprarenal stent grafts remained associated with an increased risk of renal deterioration (OR 2.0; 95% CI 1.2-3.4) and prolonged length of stay (OR 1.8; 95% CI 1.4-2.2). Among routine users, suprarenal fixation was also associated with higher rates of renal dysfunction (3.7% vs. 1.3%, p = .02; OR 2.9; 95% CI 1.1-7.8). CONCLUSION: Despite potential differences in patient selection, endografts with suprarenal fixation among all users and routine users were associated with higher rates of renal deterioration and longer length of hospital stay. Longer-term data are needed to determine the duration and severity of renal function decline and to identify potential benefits of decreased migration or endoleak.

The Consequences of Real Life Practice of Early Abdominal Aortic Aneurysm Repair: A Cost-Benefit Analysis.

BACKGROUND: The reported 54 mm median intervention diameter for endovascular aneurysm repair (EVAR) in the Vascular Quality Initiative and European data from the Pharmaceutical Aneurysm Stabilisation Trial (PHAST) implies that in real life the majority of abdominal aortic aneurysm (AAA) repairs occur at diameters smaller than the consensus intervention threshold of 55 mm. This study explores the potential consequences of this practice. METHODS: The differences between real life AAA repair and consensus based intervention threshold were explored in reported data from vascular quality initiatives and PHAST. The subsequent consequences of advancement of endovascular aneurysm repair (EVAR) were estimated using a multistate model based on life tables for the EVAR Medicare population. RESULTS: There appears an approximate 5 mm difference in AAA diameter between real life practice and consensus intervention threshold. Assuming a 2.5 mm annual growth rate, this results in an approximately 2 year advancement of AAA repair. According to the model used, early repair reduces overall small aneurysm patient mortality by 2.3%, it results in 21.9% more EVAR procedures, more EVAR related deaths, and 42.3% and 36.8% more open and endovascular re-interventions, respectively. Cost-benefit estimates imply 482 fewer AAA related deaths, but 140 extra EVAR related deaths for a population of more than 30,000 AAA patients, and a 300 million USD increase in health costs for the 8 year observation period in the Medicare population. CONCLUSIONS: In the real life situation a large proportion of EVAR procedures appear to occur before reaching the consensus threshold. Although this reduces mortality, it comes at a cost of approximately 1 million USD per prevented rupture related death.

Comparison of Renal Complications between Endografts with Suprarenal and Infrarenal Fixation.

OBJECTIVES: Surgeons have multiple grafts options available for the endovascular treatment of abdominal aortic aneurysm (EVAR), and some hypothesize that suprarenal fixation endografts may result in higher rates of renal complications than infrarenal endografts. This study aimed to compare the outcomes of contemporary suprarenal and infrarenal endografts. METHODS: The Targeted Vascular Module of the National Surgical Quality Improvement Project was utilised to identify patients undergoing EVAR for infrarenal aneurysm from 2011 to 2013. Pre-operative and operative variables and 30 day outcomes were compared among suprarenal (Zenith and Endurant) and infrarenal fixation devices (Excluder). Renal complications included creatinine increase > 2 mg/dL or new dialysis, as defined by NSQIP. Multivariate regression was completed to account for patient demographics, comorbidities, and operative characteristics. RESULTS: A total of 3587 patients were evaluated including 2273 (63%) with suprarenal grafts and 1314 (37%) with infrarenal grafts. Patients with suprarenal grafts were less commonly white (84% vs. 88%, p < .01) and more commonly male (83% vs. 80%, p = .03). There were no differences in age or comorbidities. Renal complications (1.1% vs. 0.1%, p < .01) and length of stay more than 2 days (34% vs. 25%, p < .01) occurred more commonly after suprarenal fixation. After adjustment, suprarenal grafts had significantly higher rates of renal complications (OR, 12.0; 95% CI, 1.6-91) and length of stay more than 2 days (OR, 1.4; 95% CI, 1.2-1.7). CONCLUSION: Overall rates of renal complications following EVAR are low. Patients selected for suprarenal stent grafts are at increased risk of renal complications and prolonged length of stay, which may be due to selection bias, deployment techniques, or the presence of a bare stent overlying the renal arteries. Further studies are necessary to evaluate the mechanism and duration of renal dysfunction and important long-term outcomes of interest.

Comparison of outcomes after endovascular and open repair of abdominal aortic aneurysms in low-risk patients.

BACKGROUND: In randomized trials endovascular aortic aneurysm repair (EVAR) has been shown to have superior perioperative outcomes compared with open aneurysm repair (OAR). However, outcomes in patients at low risk of complications are unclear and many surgeons still prefer OAR in this cohort. The objective was to analyse perioperative and longer-term outcomes of OAR and EVAR in this low-risk group of patients. METHODS: All elective infrarenal EVARs and OARs in the Vascular Study Group of New England database were reviewed from 2003 to 2014. The Medicare scoring system was used to identity patients at low risk of perioperative complications and death. Perioperative and longer-term outcomes were analysed in this cohort. A Kaplan-Meier plot was constructed for evaluation of longer-term survival. Further propensity matching and multivariable analysis were performed to analyse additional differences between the two groups. RESULTS: Some 1070 patients who underwent EVAR and 476 who had OAR were identified. Mean(s.d.) age was 67·3(5·7) and 65·1(6·3) years respectively (P < 0·001). EVAR was associated with a lower overall perioperative complication rate (4·2 versus 26·5 per cent; P < 0·001). There was no difference in 30-day mortality (0·4 versus 0·6 per cent; P = 0·446). Overall survival at 3 years was similar after EVAR and OAR (92·5 versus 92·1 per cent respectively; P = 0·592). In multivariable analyses there was no difference in freedom from reintervention (odds ratio 1·69, 95 per cent c.i. 0·73 to 3·90; P = 0·220) or survival (hazard ratio 0·85, 0·61 to 1·20; P = 0·353). CONCLUSION: In patients predicted to be at low risk of perioperative death following aneurysm repair, EVAR resulted in fewer perioperative complications than OAR. However, perioperative mortality, reinterventions and survival rates in the longer term appeared similar between endovascular and open repair.

Clinical relevance of cranial nerve injury following carotid endarterectomy.

OBJECTIVES: The benefit of carotid endarterectomy (CEA) may be diminished by cranial nerve injury (CNI). Using a quality improvement registry, we aimed to identify the nerves affected, duration of symptoms (transient vs. persistent), and clinical predictors of CNI. METHODS: We identified all patients undergoing CEA in the Vascular Study Group of New England (VSGNE) between 2003 and 2011. Surgeon-observed CNI rate was determined at discharge (postoperative CNI) and at follow-up to determine persistent CNI (CNIs that persisted at routine follow-up visit). Hierarchical multivariable model controlling for surgeon and hospital was used to assess independent predictors for postoperative CNI. RESULTS: A total of 6,878 patients (33.8% symptomatic) were included for analyses. CNI rate at discharge was 5.6% (n = 382). Sixty patients (0.7%) had more than one nerve affected. The hypoglossal nerve was most frequently involved (n = 185, 2.7%), followed by the facial (n = 128, 1.9%), the vagus (n = 49, 0.7%), and the glossopharyngeal (n = 33, 0.5%) nerve. The vast majority of these CNIs were transient; only 47 patients (0.7%) had a persistent CNI at their follow-up visit (median 10.0 months, range 0.3-15.6 months). Patients with perioperative stroke (0.9%, n = 64) had significantly higher risk of CNI (n = 15, CNI risk 23.4%, p < .01). Predictors for CNI were urgent procedures (OR 1.6, 95% CI 1.2-2.1, p < .01), immediate re-exploration after closure under the same anesthetic (OR 2.0, 95% CI 1.3-3.0, p < .01), and return to the operating room for a neurologic event or bleeding (OR 2.3, 95% CI 1.4-3.8, p < .01), but not redo CEA (OR 1.0, 95% CI 0.5-1.9, p = .90) or prior cervical radiation (OR 0.9, 95% CI 0.3-2.5, p = .80). CONCLUSIONS: As patients are currently selected in the VSGNE, persistent CNI after CEA is rare. While conditions of urgency and (sub)acute reintervention carried increased risk for postoperative CNI, a history of prior ipsilateral CEA or cervical radiation was not associated with increased CNI rate.

Intra-aneurysmal pressure after incomplete endovascular exclusion.

PURPOSE: An endoleak results from the incomplete endovascular exclusion of an aneurysm. We developed an experimental model to analyze hemodynamic changes within the aneurysm sac in the presence of an endoleak, with and without a simulated open collateral branch. METHODS: With a latex aneurysm model connected to a pulsatile pump, pressures were measured simultaneously within the system (systemic pressure) and the aneurysm sac (intrasac pressure). The experiments were performed without endoleak (control group) and after creating a 3.5-mm (group 1), 4.5-mm (group 2), and 6-mm (group 3) diameter orifice in the endograft, simulating an endoleak. Pressures were also registered with and without a patent aneurysm side branch. RESULTS: In each endoleak group, the intrasac diastolic pressure (DP) and mean pressure (MP) were significantly higher than the systemic DP and MP (P =.01, P =.006, and P =.001, respectively), although the pressure curve was damped. The presence of an open side branch significantly reduced the intrasac DP and MP. CONCLUSION: In this model, intrasac pressures were significantly higher than systemic pressures in the presence of all endoleaks, even the smallest ones. Intrasac pressures higher than systemic pressure may pose a high risk for aneurysm rupture. Although patent side branches significantly reduce these pressures, the aggressive management of an endoleak should be pursued.

Results of endovascular superficial femoral endarterectomy.

BACKGROUND: Endovascular superficial femoral artery (SFA) endarterectomy with a ring stripper/cutter and distal stenting has been suggested to have a patency comparable with above-knee bypass surgery. We report our initial experience with this technique. METHODS: Seventeen patients (13 men and 4 women; mean age, 64 years) with SFA occlusion and above-knee popliteal reconstitution underwent attempted remote endarterectomy with a ring cutter system combined with primary stenting of the distal end point. Analysis was performed in a prospective manner with patency rates determined by Kaplan-Meier life-table analysis. RESULTS: The indication for operation was claudication in 8 patients, rest pain in 6, and tissue loss in 3. Initial technical success was achieved in 11 patients (65%). Reasons for technical failure included SFA perforation (4), inability to traverse a calcified/diseased segment (1), and inability to retract/remove the ring cutter (1). Life-table analysis of all patients revealed a primary patency at 1 year of 26% +/- 11%. Primary-assisted patency was 38% +/- 12% at 1 year, with 59% of patients ultimately requiring surgical bypass grafting. In patients in whom initial technical success was achieved, the 1-year primary and primary-assisted patency rates were 40% and 59%, respectively. There were four reocclusions requiring surgical revascularization with below-knee popliteal (2) or tibial (2) bypass grafting, 1 symptomatic restenosis requiring repeat angioplasty, and 1 symptomatic restenosis treated conservatively. CONCLUSION: The results of endovascular SFA endarterectomy were disappointing, with technical success in less than two thirds of patients and a 1-year primary patency of only 26%. Remote SFA endarterectomy appears less effective than above-knee femoropopliteal bypass grafting, and after early failure, patients may require more distal revascularization for limb salvage.

Sialyl LewisX oligosaccharide preserves myocardial and endothelial function during cardioplegic ischemia.

BACKGROUND: Neutrophil adhesion to endothelium contributes to myocardial reperfusion injury after cardiac operation. Initial neutrophil-endothelial interactions involve selectins, which bind Sialyl-LewisX on neutrophils. Blockade of selectin-mediated neutrophil-endothelial interactions with CY-1503, a synthetic analogue of Sialyl-LewisX, might reduce reperfusion injury after myocardial ischemia. METHODS: The efficacy of CY-1503 to attenuate global myocardial reperfusion injury was assessed in isolated blood-perfused neonatal lamb hearts that had 2 hours of cold cardioplegic ischemia. CY-1503 (40 mg/L) or saline vehicle was added to blood perfusate before ischemia. Contractile function (developed pressure, dP/dt) and coronary vascular endothelial function (acetylcholine response) were assessed at base line and during reperfusion. Myocardial neutrophil accumulation was assessed by myeloperoxidase quantification. RESULTS: Compared to controls, treatment with CY-1503 improved recovery of all indices of contractile function, preserved coronary vascular endothelial function, and reduced myocardial neutrophil accumulation. CONCLUSIONS: In isolated neonatal lamb hearts that underwent hypothermic cardioplegic ischemia, CY-1503 administration reduced myocardial neutrophil accumulation and preserved endothelial and contractile function. Selectin blockade of leukocyte-endothelial interactions might attenuate reperfusion injury and enhance myocardial protection during cardiac surgical procedures.

Sialyl lewis oligosaccharide preserves cardiopulmonary and endothelial function after hypothermic circulatory arrest in lambs.

OBJECTIVE: Neutrophil adhesion to endothelium contributes to cardiopulmonary dysfunction after cardiac surgical procedures. Initial neutrophil-endothelial interactions involve selectins, which bind carbohydrate ligands, such as sialyl-Lewis(X). Blockade of selectin-mediated neutrophil interactions with CY1503, a synthetic oligosaccharide analog of sialyl-Lewis(X), could limit neutrophil-mediated injury after cardiopulmonary bypass. METHODS: The efficacy of CY1503 treatment was tested in a lamb model of cardiopulmonary bypass with hypothermic circulatory arrest. Neonatal lambs received CY1503 (n = 6, CPB-CY1503) or saline solution vehicle (n = 7, CPB-saline) into the pump prime before bypass and as a continuous infusion throughout reperfusion. Five lambs served as control animals for in vitro microvessel studies. Indexes of myocardial function (preload recruitable stroke work index, and rate of pressure rise) and pulmonary function (compliance, airway resistance, and arterial PO (2)) were measured before bypass and during reperfusion. The effect of CY1503 on endothelium-dependent vascular reactivity was assessed by means of in vitro pulmonary and coronary microvessel studies. RESULTS: Myocardial function was depressed after circulatory arrest, but CY1503 preserved function near baseline (36% +/- 25% vs 99% +/- 19% of baseline at 3 hours of reperfusion). CY1503-treated animals also demonstrated improved pulmonary function during reperfusion. In vitro microvessel analysis of vascular reactivity revealed endothelial dysfunction after circulatory arrest compared with control lambs. CY1503-treated lambs (CPB-CY1503) had intact endothelial function, as demonstrated by normal vasodilatory responses to endothelium-dependent vasodilators. CONCLUSIONS: CY1503 preserves cardiopulmonary and endothelial function after cardiopulmonary bypass and hypothermic circulatory arrest in neonatal lambs. This suggests a role for selectin-mediated, neutrophil-endothelial interactions in the inflammatory response after cardiac operations.

Cost-effectiveness of surgery for small abdominal aortic aneurysms on the basis of data from the United Kingdom small aneurysm trial.

PURPOSE: Although the United Kingdom small aneurysm trial reported no survival benefit for early operation in patients with small (4. 0-5.5 cm) abdominal aortic aneurysms (AAAs), the trial lacked statistical power to detect small but potentially meaningful gains in life expectancy, particularly for specific subgroups. We used decision analysis to better characterize the potential benefits and cost-effectiveness of early surgery. METHODS: We used a Markov model to assess the marginal cost-effectiveness (incremental cost per quality-adjusted life year [QALY] saved) of early surgery relative to surveillance for small AAAs, using data from the UK Trial. Subgroup analyses were performed by patient age and AAA diameter. Sensitivity analysis was used to evaluate the effect of elective operative mortality on cost-effectiveness. RESULTS: In our baseline analysis, early operations provided a small survival advantage (0.14 QALYs) at a small incremental cost of $1510. Thus, despite a small survival benefit, early surgery appeared cost-effective ($10, 800/QALY). The small cost differential resulted from the large proportion of patients who underwent surveillance, who eventually underwent AAA repair, and therefore incurred the cost of the surgical procedures. The survival advantage and cost-effectiveness of early operation increased with lower operative mortality, younger age, and larger AAA diameter. CONCLUSION: Despite the negative conclusions of the UK trial, early surgery may be cost-effective for patients with small AAAs, particularly younger patients (<72 years of age) with larger AAAs (> or = 4.5 cm). Because the gains in life expectancy are relatively small, however, clinical decision making should be strongly guided by patient preferences.

Blockade of selectin-mediated leukocyte adhesion improves postischemic function in lamb hearts.

BACKGROUND: Leukocyte-endothelial interactions appear to have a important role in ischemia/reperfusion injury and are mediated by specific leukocyte and endothelial adhesion molecules. The selectins are adhesion molecules found on leukocytes (L-selectin) and endothelium (P and E selectin) that bind to oligosaccharide ligands containing fucose and sialic acid to mediate leukocyte rolling on the endothelium. Fucoidin is a nontoxic sulfated fucose oligosaccharide derived from seaweed that blocks the selectins. METHODS: We tested the effects of fucoidin in an isolated blood-perfused neonatal (age range, 3 to 7 days; mean age, 4.3 days) lamb heart model undergoing 2 hours of cold cardioplegic ischemia. In group F (n = 8) fucoidin (30 mg/L) was added at initial reperfusion. Group C (n = 9) received only cardioplegia with no reperfusion intervention. Isovolumic maximum developed pressure and the maximum positive and negative first derivatives of pressure were measured using a catheter-tip transducer in an intraventricular balloon before ischemia and at 30 minutes of reperfusion. Coronary blood flow, myocardial oxygen consumption, and white blood cell counts in the circulating blood were also measured. RESULTS: Percent recoveries of baseline maximum developed pressure and maximum positive and negative first derivatives of pressure in group F (86% +/- 5%, 81% +/- 10%, and 74% +/- 8%, respectively; mean +/- standard deviation) were higher than in group C (77% +/- 5%, 70% +/- 9%, and 65% +/- 6%; p < 0.05). Group F postischemic coronary blood flow was greater (190% +/- 35%) than in group C (102% +/- 10%; p < 0.05). Recovery of myocardial oxygen consumption in group F (86% +/- 14%) was greater than group C (72% +/- 11%; p < 0.05). Postischemic white blood cell count in group F (88% +/- 4%) was greater than in group C (81% +/- 5%; p < 0.05). CONCLUSIONS: Selectin blockade with fucoidin resulted in better recovery of left ventricular function, coronary blood flow, and myocardial oxygen consumption after cold ischemia, despite a higher circulating white blood cell count. These data support the hypothesis that endothelial-leukocyte interactions play an important role in ischemia/reperfusion and suggest that selectin blockade may be a useful therapeutic strategy.

Age differences in effects of hypothermic ischemia on endothelial and ventricular function.

BACKGROUND: Prior studies indicate that immature myocardium has a greater tolerance to ischemia. Prior studies from our laboratory have shown that impaired postischemic endothelial function was correlated with reduced ventricular contractility, and that coronary endothelium has an important role in ischemia and reperfusion injury in neonatal hearts. METHODS: We examined the differences of endothelial function as well as ventricular function between immature and mature hearts in isolated blood-perfused lamb and sheep hearts after 2 hours of 15 degrees C cardioplegic ischemia. Three groups were defined according to age: neonatal ( < 1 week) hearts (n = 8), infant (1 month) hearts (n = 8), and adult (1 year) hearts (n = 6). Each of the three groups underwent a similar protocol including ischemic time, myocardial temperature, and cardioplegic solution. Based on earlier work, all had low perfusion pressures during the first 10 minutes of reperfusion. Thereafter the perfusion pressure was constant at 60 mm Hg in the neonatal hearts, 80 mm Hg in the infant hearts, and 100 mm Hg in the adult hearts to match the mean arterial pressure at each age in this species. RESULTS: At 30 minutes of reperfusion, the neonatal and infant hearts achieved significantly improved recovery of left ventricular systolic (maximum developed pressure and positive first time derivative of pressure, and volume normalized developed pressure and first time derivative of pressure) and diastolic (negative maximum first time derivative of pressure) functions and coronary blood flow. The postischemic endothelial function determined by the coronary vasodilator response to acetytlcholine was better in the neonatal and infant hearts compared with the adult hearts (p < 0.05). CONCLUSIONS: These results show that the immature hearts had better recovery of endothelial function and coronary blood flow as well as ventricular function compared with adult hearts after hypothermic ischemia and reperfusion. These results combined with previous studies add further support to the concept that events in the coronary vascular bed play an important role in reperfusion injury in both immature and mature hearts.