One-Year Outcomes of Endovascular Aneurysm Repair in High-Risk Patients Using the Endurant Stent-Graft: Comparison of the ASA Classification and SVS/AAVS Medical Comorbidity Grading System for the Prediction of Mortality and Adverse Events.

PURPOSE: To evaluate the outcome and survival of patients with extensive comorbid conditions after endovascular aneurysm repair (EVAR) and objectify which of 2 medical comorbidity classifications is more accurate in predicting adverse outcomes. METHODS: All 1263 patients (mean age 73.1 years; 1129 men) treated using the Endurant Stent Graft system and entered in the prospective global postmarketing ENGAGE registry (ClinicalTrials.gov identifier NCT00870051) were grouped using the American Society of Anesthesiologists (ASA) classification and the Society for Vascular Surgery/American Association for Vascular Surgery (SVS/AAVS) medical comorbidity grading system. Patients assigned to ASA III and IV and SVS/AAVS 2 and 3 categories were considered high risk. Primary outcome was 1-year all-cause mortality. Secondary outcomes included technical and clinical success, major adverse events (MAE), aneurysm rupture, endoleaks, and secondary endovascular procedures. One-year follow-up of the entire ENGAGE cohort was the endpoint of the study. RESULTS: A total of 1263 patients were included. The overall technical success rate was high, the lowest being 97.4% in the ASA I group. The overall 30-day and 1-year Kaplan-Meier survival estimates were 98.7% and 92.5%, respectively. All cause 1-year mortality was higher in the ASA III and IV groups, but this did not reach statistical significance (5.2% and 5.7% for ASA I and II vs 9.0% and 9.9% for ASA III and IV, p=0.12). In the SVS/AAVS groups, 1-year all-cause mortality significantly increased with the SVS/AAVS score to 11.3% in the SVS/AAVS 3 group (p=0.002). There were significantly more MAEs in the SVS/AAVS 3 group at 1 year (p<0.001 for group 1 vs 3 and group 2 vs 3). CONCLUSION: Endovascular aneurysm repair has evolved, and high technical success and low mortality and morbidity can be achieved in high-risk patients. When treating high-risk patients, the perioperative risks should always be weighed against the expected gains. In contrast to the ASA classification, the SVS/AAVS medical comorbidity grading system is a useful tool to predict occurrence of MAEs and 1-year survival in patients undergoing EVAR.

EndoAnchors to Resolve Persistent Type Ia Endoleak Secondary to Proximal Cuff With Parallel Graft Placement.

PURPOSE: To describe 2 patients with a distally migrated endograft causing a type Ia endoleak and treatment with a proximal cuff and chimney grafts that required EndoAnchors to finally seal the leak. CASE REPORT: Two men, ages 86 and 72 years, presented with stent-graft migration and type Ia endoleak at 5 and 15 years after endovascular repair, respectively. Both were treated with a proximal cuff in combination with a chimney graft to the left renal artery. In both cases, the type Ia endoleak persisted, likely due to gutter formation. Both patients were treated in the same setting with EndoAnchors that instantly resolved the endoleak. At 1-year follow-up, there was no recurrent endoleak or migration, with patent chimney grafts and renal arteries and stable renal function. CONCLUSION: EndoAnchors may effectively resolve a persistent type Ia endoleak arising from gutter formation after placement of a proximal cuff and chimney grafts.

Dutch experience with the fenestrated Anaconda endograft for short-neck infrarenal and juxtarenal abdominal aortic aneurysm repair.

OBJECTIVE: In the past decennium, the management of short-neck infrarenal and juxtarenal aortic aneurysms with fenestrated endovascular aneurysm repair (FEVAR) has been shown to be successful, with good early and midterm results. Recently, a new fenestrated device, the fenestrated Anaconda (Vascutek, Renfrewshire, Scotland), was introduced. The aim of this study was to present the current Dutch experience with this device. METHODS: A prospectively held database of patients treated with the fenestrated Anaconda endograft was analyzed. Decision to treat was based on current international guidelines. Indications for FEVAR included an abdominal aortic aneurysm (AAA) with unsuitable neck anatomy for EVAR. Planning was performed on computed tomography angiography images using a three-dimensional workstation. RESULTS: Between May 2011 and September 2013, 25 patients were treated in eight institutions for juxtarenal (n = 23) and short-neck AAA (n = 2). Median AAA size was 61 mm (59-68.5 mm). All procedures except one were performed with bifurcated devices. A total of 56 fenestrations were incorporated, and 53 (94.6%) were successfully cannulated and stented. One patient died of bowel ischemia caused by occlusion of the superior mesenteric artery. On completion angiography, three type I endoleaks and seven type II endoleaks were observed. At 1 month of follow-up, all endoleaks had spontaneously resolved. Median follow-up was 11 months (range, 1-29 months). There were no aneurysm ruptures or aneurysm-related deaths and no reinterventions to date. Primary patency at 1 month of cannulated and stented target vessels was 96%. CONCLUSIONS: Initial and short-term results of FEVAR using the fenestrated Anaconda endograft are promising, with acceptable technical success and short-term complication rates. Growing experience and long-term results are needed to support these findings.

Endovascular aneurysm sealing for juxtarenal aneurysm using the Nellix device and chimney covered stents.

PURPOSE: To show the feasibility of the Nellix device in conjunction with a chimney technique for treating juxtarenal aneurysms in two patients who were deemed unsuitable for fenestrated endovascular aneurysm repair or open surgery. CASE REPORTS: Two men aged 83 and 81 years were referred with a juxtarenal abdominal aortic aneurysm (66 and 69 mm, respectively). Both were considered for open surgery as well as custom-made fenestrated stent-graft but deemed unsuitable for both options. They were both treated using the Nellix endoprosthesis in combination with chimney grafts to preserve the renal arteries. Technical success was achieved in both cases, with successful aneurysm exclusion and target vessel preservation (the right renal artery in the first case and both renal arteries in the second). At 6 months, duplex ultrasound and computed tomographic angiography of the first patient showed no signs of endoleak and patent renal arteries. The second patient developed a right retroperitoneal hematoma with minor extravasation near the lower pole of the right kidney for which coil embolization was necessary. The subsequent clinical sequelae led to respiratory insufficiency and ultimately death. CONCLUSION: The use of the Nellix endoprosthesis combined with chimney grafts is technically feasible. The addition of chimney grafts can increase the applicability of endovascular aneurysm sealing to treat short-neck and juxtarenal aneurysms. Further studies are needed to confirm these findings and establish longer term outcome.

Use of flow-diverting stents to treat para-anastomotic iliac artery aneurysms after previous open aortic prosthetic reconstruction.

PURPOSE: To present a series of para-anastomotic iliac artery aneurysms treated with flow-diverting stents. CASE REPORTS: Three patients (2 men, 1 woman; ages 70, 73, and 78 years) with previous open aortoiliac reconstructions received a 12-mm-diameter Cardiatis Multilayer Stent to treat 4 para-anastomotic iliac artery aneurysms in an attempt to preserve their ipsilateral hypogastric arteries. After 1-year follow-up, all aneurysms were successfully excluded, with complete sac thrombosis in three and partial thrombosis in one. The diameter of the aneurysm was reduced in all by a median 6 mm. At 1 year, patency of the hypogastric artery was maintained in only the patient with partial sac thrombosis. No patient developed buttock claudication. CONCLUSION: The use of flow-diverting stents for para-anastomotic iliac artery aneurysms resulted in reduction of iliac aneurysm diameter. However, intended patency of the ipsilateral hypogastric artery was not always observed. The feasibility of the technique has therefore not been shown for this specific indication.

Treatment of a type IIIb endoleak in a Talent endograft using telescoping cuffs and two parallel upside-down excluder contralateral legs.

We describe a case of a type IIIb endoleak arising from the main body of a Talent endograft that was treated using two telescoping cuffs and two parallel upside-down inserted Excluder contralateral legs, thereby creating a new bifurcating endograft. First, a 23-mm cuff was deployed onto the flow divider of the Talent endograft, followed by a second 28-mm cuff below the renal arteries creating a tapering lumen. Two 20-mm Excluder contralateral limbs were then positioned upside-down in the 23-mm cuff and deployed simultaneously, creating a new bifurcated prosthesis. Control computed tomography (CT) scan at 6 weeks showed a good position of the endografts without signs of an endoleak. In conclusion, a type IIIb endoleak at the level of the flow divider may successfully be excluded using two telescoping cuffs and two parallel upside-down contralateral Excluder limbs. Due to the rarity of this complication, the treatment will always have to be tailor-made.

Patient and procedure-related risk factors for adverse events after infrainguinal bypass.

BACKGROUND: Current medical practice urges individual health care facilities and medical professionals to obtain and provide detailed insight in quality of care with the possibility of comparing data between institutions. Adverse event (AE) analysis serves as a mainstay in quality assessment in vascular surgery, but the comparison of AE data between facilities can be complex. The aim of the present study was to assess independent risk factors for AE occurrence: patient, disease and operation characteristics besides general differences between health care facilities. METHODS: All AEs after infrainguinal bypass graft procedures (BGPs) in three health care facilities in the Netherlands were evaluated. AEs were defined identically in the facilities. RESULTS: Of 601 BGPs performed, 662 AEs were registered. Independent predictors of AEs were female gender (odds ratio [OR], 2.13; 95% confidence interval [CI], 1.39-3.26; P < .01), age >or=60 years (OR, 0.57; 95% CI, 0.34-0.95; P = .03), American Society of Anesthesiologists classification 3-4 (OR, 1.79; 95% CI, 1.01-3.17; P = .05), comorbidities of pulmonary disease (OR, 2.99; 95% CI, 1.67-5.34; P < .01) and diabetes mellitus (OR, 2.49; 95% CI, 1.58-3.94; P < .01), distal anastomosis level at below knee femoropopliteal BGP (OR, 2.01; 95% CI, 1.26-3.22; P < .01), femorotibial BGP (OR, 2.40; 95% CI, 1.37-4.19; P < .01), and popliteopedal BGP (OR, 92.39; 95% CI, 11.13-766.98; P < .01). One health care facility had significantly fewer AEs than the other two (OR, 0.21; 95% CI, 0.13-0.35; P < .01). CONCLUSION: Age, gender, comorbidity, and type of surgery are all independent predictors of AE occurrence in vascular surgery. After adjustment for differences in these factors, one health care facility still had lower AE occurrence, which needs to be examined further.

Assessment of incidence, cause, and consequences of pressure ulcers to evaluate quality of provided care.

BACKGROUND: Pressure ulcers are one of the most frequently registered complications in general surgery. OBJECTIVE: To obtain insight into the incidence, cause, and consequences of pressure ulcers and to evaluate the value of pressure ulcer registration to assess quality of care. RESULTS: During the 9-year study period, 275 pressure ulcers were registered (5.8% of total registered complications). Age and female sex were independent risk factors for pressure ulcer development. Pressure ulcer classification was as follows: mild (53.3%), moderate (35.6%), severe (9.5%), and irreversible damage (1.5%). Patients undergoing hip surgery and major limb amputation were at risk for pressure ulcer development (10.4% and 8.8%, respectively). In most patients (89.5%), pressure ulcers had no consequences other than local wound therapy; in 12 patients (4.4%), pressure ulceration led to alteration in medication; in 15 patients (5.5%), length of hospital stay was prolonged; and four patients (0.4%) suffered from irreversible damage. CONCLUSION: The incidence of pressure ulcers is strongly correlated to sex, age, and indication of admittance. Most ulcers were classified as mild and had no consequences. The insight obtained into incidence, cause, and consequences of pressure ulcers can be used as an indicator of quality of provided care if adjusted for case mix and indication of operation.

Treatment for peripheral arterial obstructive disease: An appraisal of the economic outcome of complications.

OBJECTIVE: This study determined the average estimated total costs after treatment for peripheral arterial occlusive disease (PAOD) and evaluated the effect of postoperative complications and their consequences for the total costs. METHODS: Cost data on all admissions involving treatment for PAOD from January 2007 until July 2007 were collected. A prospective analysis was made using the patient-related risk factor and comorbidity (Society for Vascular Surgery/International Society of Cardiovascular Surgeons) classification, primary and secondary treatment, and prospectively registered complications. At admission, patients without complications were placed in group A, and those with complications were in group B. Prospectively registered complications were divided into patient management (I), surgical technique (II), patient's disease (III), and outside surgical department (IV). The consequences of these were divided into minor complication, no long-term consequence (1A), additional medication or transfusion (1B), surgical reoperation (2A), prolonged hospital stay (2B), irreversible physical damage (3), and death (4). The main outcome measures were total costs of patients and costs per patient (PP), with or without the presence of complications, cost of complications and costs per complication (PC), and the costs of their consequences calculated in euros (euro). RESULTS: Ninety patients (mean age, 71.4 years; 59% men) were included. Group B patients had a significantly higher American Society of Anesthesiologists (4) and Fontaine (3) classification and more secondary procedures. Total costs were euro 1,716,852: group A, euro 512,811 (PP euro 12,820); and group B, euro 1,204,042 (PP euro 24,081). The costs of the 115 complications were euro 568,500 (PC euro 4943). Split by the cause of the complication, costs were I, euro 95,924 (PC euro 2998); II, euro 163,137 (PC euro 8157); III, euro 289,578 (PC euro 5171); and IV, euro 19,861 (PC euro 2837). The increase of costs in group B was mainly caused by additional medication or transfusion (1B) euro 348,293 (61.3%), a surgical reoperation (2A) euro 118,054 (20.8%), or prolonged hospital stay (2B) euro 60,451 (10.6%). Patients who died caused 23% of the total costs. CONCLUSION: Complications cause an increase of the average estimated total costs in the treatment for peripheral arterial occlusive disease and are responsible for 33% of these total costs. The most expensive complications were errors in surgical technique and patient's disease, resulting in surgical reoperation or additional medication, or both, or transfusion, the two most expensive consequences.

The effect of implementation of an optimized care protocol on the outcome of arteriovenous hemodialysis access surgery.

BACKGROUND: The long-term patency of arteriovenous fistulas (AVFs) and arteriovenous grafts (AVGs) suffers from a high incidence of primary failure due to early thrombosis, myointimal hyperplasia at the venous access site, or failure to mature. A multidisciplinary meeting in vascular access surgery was initiated to optimize the timing, indication, type of intervention, and the logistics of AVFs/AVGs during the preoperative and postoperative period. This study evaluated the influence of the new optimized care protocol on the incidence of revisions (surgical and endovascular) and patency rates. METHODS: This protocol for vascular access surgery of AVFs/AVGs for hemodialysis was introduced in January 2004. It was initiated with the presence of the vascular surgeons, nephrologists, interventional radiologists, dialysis nurses, and the ultrasound technicians. Every patient who needed an AVF/AVG because of long-term treatment of chronic renal failure or awaiting kidney transplantation, or who needed a revision of an AVF/AVG, was discussed. Two groups were compared. Group I patients were treated with an AVF/AVG before the introduction of the new protocol (2001 and 2002). Group II patients were treated with an AVF/AVG after the introduction of the new optimized care protocol (2004 and 2005). Both groups were followed up after 12 months. RESULTS: During the study period, 146 AVFs/AVGs were attempted, and 111 postoperative revisions were performed to restore primary and secondary patency: 63 in group I (60 surgical, 3 radiology) and 48 in group II (23 surgical, 25 radiology). Significantly more segmental access replacements (P < 0.027) occurred in group I than in group II. Significantly fewer surgical revisions (P < 0.019) and more endovascular balloon angioplasties (P < 0.001) occurred in group II. Significantly higher cumulative primary and secondary patency rates of all AVFs/AVGs (P < 0.001), radial-cephalic direct wrist AVFs (P < 0.001), and brachial-cephalic forearm looped transposition AVGs (P < 0.001) were achieved in group II after follow-up. CONCLUSION: The new protocol outlined in a bimonthly multidisciplinary meeting for vascular access surgery of AVFs/AVGs for hemodialysis resulted in more effective logistics according to preoperative diagnostics and operation. More importantly, a significant increase in endovascular balloon angioplasties and a significant decrease in surgical revisions was observed, resulting in less patient morbidity. Also, higher primary and secondary patency was achieved after the introduction of the new optimized care protocol.

A prospective study of incidence of saphenous nerve injury after total great saphenous vein stripping.

BACKGROUND AND OBJECTIVES: Total stripping of the great saphenous vein (GSV) is a validated surgical strategy of treating patients with primary varicose veins (PVV). An often cited, but not well documented and studied, complication of total stripping is postoperative damage of the saphenous nerve (SN). OBJECTIVE: The objective was to evaluate the incidence of SN damage and to assess the therapeutic efficacy after total stripping of the GSV. MATERIALS AND METHODS: Patients undergoing total stripping of the GSV because of PVV in the entire lower limb were enrolled. Pre- and postoperative neurologic examination was performed to identify potential sensory neurologic deficits. RESULTS: Total stripping of the GSV in 69 limbs occurred because of pain (9%) or a tired feeling in the limbs (77%) or for cosmetic reasons (14%). The overall incidence of postoperative sensory neurologic deficits was 7 and 6%, respectively, after 6-week follow-up and both 3% after 3-month follow-up. In 99% of the patients, total stripping of the GSV resulted in reduction of the primary signs and symptoms. CONCLUSION: The incidence of SN damage after total stripping of the GSV is low. Thus, total stripping of the GSV resulted in improvement of the primary complaint in almost all patients. Total stripping of the GSV is an effective surgical strategy in treating PVV.

The incidence of unplanned returns to the operating room after peripheral arterial bypass surgery and its value as indicator of quality of care.

BACKGROUND: In recent years, a growing need has arisen to define possible indicators of quality of care. METHODS: To examine whether unplanned return to the operating room within 30 days after the initial procedure could serve as an indicator to assess quality of care in peripheral arterial bypass surgery, all bypass procedures performed between January 1996 and January 2004 were evaluated. Data were obtained from a prospectively kept hospital registration system. RESULTS: A total of 607 consecutive procedures were performed in 468 patients. The overall unexpected return to the operating room rate was 11.2%. Patients requiring peripheral arterial bypass surgery for critical ischemia with gangrene were significantly more at risk for an unplanned reoperation (20.2%) than patients with disabling claudication (2.1%) (P < .0001). Patients requiring femorocrural bypass surgery (24.2%) were also more at risk than patients with a suprageniculate bypass procedure (5.2%) (P < .0001). CONCLUSIONS: Unplanned return to the operating room within 30 days after the initial operation can be a useful indicator of quality of care after peripheral arterial bypass surgery. However, a prospective, well-defined registration system to collect all data is essential. Furthermore, the severity of peripheral arterial disease and the type of procedure performed should be taken into account.

Can the incidence of unplanned reoperations be used as an indicator of quality of care in surgery?

The incidence of unplanned reoperations could potentially be used as an indicator of quality of care. This study provided insight into the incidence of unplanned reoperations in a surgical department and added to the discussion of the value of unplanned reoperations as an indicator of quality of care. Between January 1996 and December 2003, all unplanned reoperations were entered prospectively into a complication registration system. The number of unplanned reoperations was 447 (1.7%). Unplanned reoperations occurred frequently after vascular (6.5%) and colon surgery (5.7%) and were caused predominantly by errors in surgical technique (70%) and patients' comorbidities (21%). Mortality for patients requiring unplanned reoperations was significantly higher than for patients who did not require reoperations (10.3% versus 4.0%). Unplanned reoperation rates can be an indicator of quality of care. However, a prospective, well-defined registry is essential to ensure an accurate assessment of the quality of care provided.

A novel urokinase receptor-targeted inhibitor for plasmin and matrix metalloproteinases suppresses vein graft disease.

AIMS: Matrix metalloproteinases (MMP) and plasminogen activator (PA)/plasmin-mediated proteolysis, especially at the cell surface, play important roles in matrix degeneration and smooth muscle cell migration, which largely contributes to vein graft failure. In this study, a novel hybrid protein was designed to inhibit both protease systems simultaneously. MMP and plasmin activity were inhibited at the cell surface by this hybrid protein, consisting of the receptor-binding amino-terminal fragment (ATF) of urokinase-type PA, linked to both the tissue inhibitor of metalloproteinases (TIMP-1) and bovine pancreas trypsin inhibitor (BPTI), a potent protease inhibitor. The effect of overexpression of this protein on vein graft disease was studied. METHODS AND RESULTS: A non-viral expression vector encoding the hybrid protein TIMP-1.ATF.BPTI was constructed and validated. Next, cultured segments of human veins were transfected with this vector. Expressing TIMP-1.ATF.BPTI in vein segments resulted in a mean 36 ± 14% reduction in neointima formation after 4 weeks. In vivo inhibition of vein graft disease by TIMP-1.ATF.BPTI is demonstrated in venous interpositions placed into carotid arteries of hypercholesterolaemic APOE*3Leiden mice. After 4 weeks, vein graft thickening was significantly inhibited in mice treated with the domains TIMP-1, ATF, or BPTI (36-49% reduction). In the TIMP-1.ATF.BPTI-treated mice, vein graft thickening was reduced by 67±4%, which was also significantly stronger when compared with the individual components. CONCLUSION: These data provide evidence that cell surface-bound inhibition of the PA and MMP system by the hybrid protein TIMP-1.ATF.BPTI, overexpressed in distant tissues after electroporation-mediated non-viral gene transfer, is a powerful approach to prevent vein graft disease.

Wound complications at the groin after peripheral arterial surgery sparing the lymphatic tissue: a double-blind randomized clinical trial.

BACKGROUND: The groin incision after arterial reconstructive surgery is most likely at risk for infectious or lymphatic wound complications. Theoretically; sparing lymphatic tissue by a lateral approach to the femoral artery should minimize these. The aim of this study was to assess the incidence of wound complications after the lateral versus the direct approach of the common femoral artery. METHODS: The study population included all patients who underwent an exploration of the common femoral artery between May 2002 and December 2005. RESULTS: After 6 weeks, no statistical differences in the occurrence of wound complications could be shown. A wound infection was present after 6 weeks in 6.1% in the direct group versus 6.0% in the lateral group. Lymphorrhea was persistent in 3.1% in the direct group versus 5.0% in the lateral group. CONCLUSIONS: Using a lateral vertical incision for the approach of the common femoral artery did not decrease the incidence of postoperative wound complications.

Nosocomial infections after peripheral arterial bypass surgery.

BACKGROUND: Hospital-acquired infections account for a substantial increase in morbidity and mortality. This prospective, single-center observational study was conducted to assess the incidence and analyze the risk factors of nosocomial infection after peripheral arterial bypass surgery. METHODS: The incidence of nosocomial infections was registered in all patients undergoing peripheral arterial bypass surgery from January 1996 until December 2004, and risk factors for the development of a nosocomial infection were analyzed. RESULTS: A total of 67 infections were diagnosed in association with 607 procedures, yielding an infection ratio of 10.0%. Surgical site infection was the most common (55.2%), followed by urinary tract infection (16.4%), pneumonia (14.9%) and bacteremia (10.4%). Staphylococcus aureus was the most commonly found isolate in surgical site infections (48.6%) and in bacteremia (42.9%). Age, the use of corticosteroids (p = 0.02), and critical ischemia with tissue loss (p = 0.009) could be identified as risk factors for the development of a nosocomial infection. Blood transfusion was a postoperative risk factor for nosocomial infection (p < .0001). Nosocomial infection was associated with a prolonged hospital stay (p < .0001). CONCLUSIONS: This study provides a detailed description of the incidence and risk factors regarding nosocomial infection. More detailed studies are necessary to develop strategies to diminish the occurrence of nosocomial infection.

Value of keeping records of mortality.

OBJECTIVE: To evaluate treatment and complications which is essential for good medical practice. DESIGN: Prospective audit. SETTING: City hospital, The Netherlands. SUBJECTS: All the patients who died on the surgical ward between 1994 and 1998 and were classified according to four categories of mortality recording. INTERVENTIONS: The causes of death, inaccuracies in treatment and the extent of agreement between premortem and postmortem findings were documented. MAIN OUTCOME MEASURES: Morbidity and mortality. RESULTS: Of the 11,195 patients admitted, 420 (4%) deceased during their hospital stay. Most patients died of the disease with which they presented at admission (n = 176, 42%) or of complications (n = 167, 40%). In 20% (n = 83) of the cases a shortcoming in the clinical course was found. 251 of the 420 patients who died (60%) had a necropsy. 53 of the 251 reports (21%) gave information that could have had an effect on the treatment or the clinical course. CONCLUSIONS: Recording mortality is a way of testing the diagnostic and therapeutic accuracy in our quest for a high quality of care.