Long-term comparison of endovascular and open repair of abdominal aortic aneurysm.

BACKGROUND: Whether elective endovascular repair of abdominal aortic aneurysm reduces long-term morbidity and mortality, as compared with traditional open repair, remains uncertain. METHODS: We randomly assigned 881 patients with asymptomatic abdominal aortic aneurysms who were candidates for both procedures to either endovascular repair (444) or open repair (437) and followed them for up to 9 years (mean, 5.2). Patients were selected from 42 Veterans Affairs medical centers and were 49 years of age or older at the time of registration. RESULTS: More than 95% of the patients underwent the assigned repair. For the primary outcome of all-cause mortality, 146 deaths occurred in each group (hazard ratio with endovascular repair versus open repair, 0.97; 95% confidence interval [CI], 0.77 to 1.22; P=0.81). The previously reported reduction in perioperative mortality with endovascular repair was sustained at 2 years (hazard ratio, 0.63; 95% CI, 0.40 to 0.98; P=0.04) and at 3 years (hazard ratio, 0.72; 95% CI, 0.51 to 1.00; P=0.05) but not thereafter. There were 10 aneurysm-related deaths in the endovascular-repair group (2.3%) versus 16 in the open-repair group (3.7%) (P=0.22). Six aneurysm ruptures were confirmed in the endovascular-repair group versus none in the open-repair group (P=0.03). A significant interaction was observed between age and type of treatment (P=0.006); survival was increased among patients under 70 years of age in the endovascular-repair group but tended to be better among those 70 years of age or older in the open-repair group. CONCLUSIONS: Endovascular repair and open repair resulted in similar long-term survival. The perioperative survival advantage with endovascular repair was sustained for several years, but rupture after repair remained a concern. Endovascular repair led to increased long-term survival among younger patients but not among older patients, for whom a greater benefit from the endovascular approach had been expected. (Funded by the Department of Veterans Affairs Office of Research and Development; OVER ClinicalTrials.gov number, NCT00094575.).

Outcomes following endovascular vs open repair of abdominal aortic aneurysm: a randomized trial.

CONTEXT: Limited data are available to assess whether endovascular repair of abdominal aortic aneurysm (AAA) improves short-term outcomes compared with traditional open repair. OBJECTIVE: To compare postoperative outcomes up to 2 years after endovascular or open repair of AAA in a planned interim report of a 9-year trial. DESIGN, SETTING, AND PATIENTS: A randomized, multicenter clinical trial of 881 veterans (aged > or = 49 years) from 42 Veterans Affairs Medical Centers with eligible AAA who were candidates for both elective endovascular repair and open repair of AAA. The trial is ongoing and this report describes the period between October 15, 2002, and October 15, 2008. INTERVENTION: Elective endovascular (n = 444) or open (n = 437) repair of AAA. MAIN OUTCOME MEASURES: Procedure failure, secondary therapeutic procedures, length of stay, quality of life, erectile dysfunction, major morbidity, and mortality. RESULTS: Mean follow-up was 1.8 years. Perioperative mortality (30 days or inpatient) was lower for endovascular repair (0.5% vs 3.0%; P = .004), but there was no significant difference in mortality at 2 years (7.0% vs 9.8%, P = .13). Patients in the endovascular repair group had reduced median procedure time (2.9 vs 3.7 hours), blood loss (200 vs 1000 mL), transfusion requirement (0 vs 1.0 units), duration of mechanical ventilation (3.6 vs 5.0 hours), hospital stay (3 vs 7 days), and intensive care unit stay (1 vs 4 days), but required substantial exposure to fluoroscopy and contrast. There were no differences between the 2 groups in major morbidity, procedure failure, secondary therapeutic procedures, aneurysm-related hospitalizations, health-related quality of life, or erectile function. CONCLUSIONS: In this report of short-term outcomes after elective AAA repair, perioperative mortality was low for both procedures and lower for endovascular than open repair. The early advantage of endovascular repair was not offset by increased morbidity or mortality in the first 2 years after repair. Longer-term outcome data are needed to fully assess the relative merits of the 2 procedures. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00094575.

Femoral arterial access management for endovascular aortic aneurysm repair: evolution and outcome.

Endovascular repair of abdominal and thoracic aortic aneurysms (AAAs and TAAs, respectively) has become the standard of care for anatomically appropriate patients. All the devices developed to date for endograft repair of AAAs and TAAs are deployed through relatively large (12F to 24F) sheaths. Traditionally, this access has required arterial exposure with open cut down, but with the development of suture-mediated arterial closure devices and decreasing profile of delivery sheaths of endografts, there is an increasing trend toward percutaneous endovascular repair of aortic aneurysms. This is an effective and safe approach in a select group of patients. Ultrasound guidance ensures that access is obtained proximal to the common femoral artery bifurcation. The procedure should be performed in a sterile operating room environment, and the physicians performing endovascular repair should be experienced in open arterial exposure, should the closure device fail to close the arteriotomy.

Recanalization of infrainguinal vessels: silverhawk, laser, and the remote superficial femoral artery endarterectomy.

There are multiple endovascular options to achieve percutaneous revascularization of chronic superficial femoral artery (SFA) stenoses and occlusions. Most rely on forceful displacement of plaque via balloon angioplasty, either as a stand-alone therapy or supplemented by cold thermal injury (cryoplasty), microtome assistance (cutting balloon angioplasty), nitinol stent deployment, or expanded polytetrafluoroethylene-lined nitinol stent deployment. Excellent technical success rates are routinely described in the literature. The essential problem associated with these techniques is the predictable compromise of the initial result by neointimal hyperplasia leading to poor long-term results. An alternative to forceful displacement techniques is use of directional atherectomy or excimer laser to debulk the atheromatous lesion, with the addition of low-pressure angioplasty or stent deployment as needed. Currently, directional atherectomy is performed using the Silverhawk Plaque Excision System (FoxHollow, Redwood City, CA), while laser atherectomy is frequently performed with the CLIRpath Excimer Laser (Spectranetics Corp., Colorado Springs, CO). While both techniques can be utilized for de novo atherosclerotic lesions, even eccentric lesions or ostial lesions, proponents of these devices have also shown good short-term results in the treatment of restenoses. Remote SFA endarterectomy with the Aspire stent (Vascular Architects, San Jose, CA) is a hybrid surgical and endovascular technique that is useful for debulking plaque from the SFA with adjunctive stenting of the distal SFA. We present a review of various alternative techniques to forceful balloon dilation used in the recanalization of the SFA with potential pitfalls and complications, along with a review of literature associated with each of these techniques.

Secondary interventions after endovascular abdominal aortic aneurysm repair.

BACKGROUND: One adverse outcome of endovascular abdominal aortic aneurysm (AAA) repair (EVAR) is a significantly increased incidence of secondary interventions (SIs) required compared with traditional open aortic repair. We present a consecutive series of EVARs using a single endograft to identify the incidence and types of SIs performed. METHODS: From February 1, 2000, to January 31, 2005, we repaired 136 AAAs with the Zenith (Cook, Bloomington, Indiana) endograft. All patients met the same strict anatomic inclusion and exclusion criteria. Follow-up lasted from 1.5 to 61 months (median 36). The indications for SI group A were procedural and technical errors, for group B were aortic morphology, and for group C were device failures. RESULTS: Twenty-one SIs were required in 17 of 136 patients (12.5%). Three patients required multiple interventions. Nine patients were in group A, four were in group B, and six were in group C. All but 4 patients required SIs for late (>30 days) complications. CONCLUSIONS: Although it is a viable alternative to open aortic repair, EVAR is associated with a significantly higher rate of SIs. To maintain the efficacy of EVAR, patients must be followed-up in a vigilant graft surveillance protocol for life.

Endovascular vs open AAA repair: does size matter?

Since the natural tendency of the aorta is to increase in diameter and tortuosity with age and since abdominal aortic aneurysms (AAAs) increase in diameter and length over time, encroaching on the renal and hypogastric orifices, early repair of AAAs (when > or =4.0 cm) may allow greater applicability of the endovascular option because of more favorable aortoiliac morphology. Patients who present at an older age with larger AAAs should be more likely to be anatomically excluded from endovascular AAA repair. Over a 42-month period, 317 consecutive patients referred with aortoiliac aneurysms (infrarenal AAA > or =4.0 cm) were evaluated by one of the authors (SGL) for endovascular vs open repair based on computed tomography (CT) and angiographic imaging. The 10 anatomic exclusion criteria were those applicable to the Zenith endograft (Cook, Inc), which currently is the most anatomically inclusive of the aortic endografts in commercial use in the United States. Based on their aortoiliac morphology, 212 patients were excluded from endovascular repair and 105 were included as acceptable anatomic candidates. Age, AAA size, and the reason(s) for exclusion were recorded for each patient. By use of Student's t test and logistic and linear regression analyses, the groups were compared by age, AAA size, and age + size. There was no significant difference in patient age or AAA size distribution between the group of patients excluded from endovascular repair based on aortoiliac morphology compared to those who met the inclusion criteria. Patients with small AAAs (4.0-5.4 cm) had similar age distribution as those with large (> or =5.5 cm) AAAs. The majority of patients (87%) were excluded based on proximal aortic neck morphology. The presence of aortoiliac morphology that precludes endovascular repair is independent of patient age or AAA size at presentation. A patient presenting with a small (4.0-5.4 cm) AAA is not more likely to be a candidate for endovascular repair than a patient with a large AAA.

Characterization of endoleaks by dynamic computed tomographic angiography.

BACKGROUND: Current imaging modalities may not be able to detect endoleaks, differentiate between type II and type III, or localize inflow and outflow sources. We describe a new technique that can characterize endoleaks to guide secondary intervention. METHODS: One hundred four patients with Zenith (Cook, Inc.) endograft repair of abdominal aortic aneurysms (AAAs) were monitored by serial computed tomographic angiography (CTA). Endoleaks were evaluated with a dynamic CTA using a stationary table position, 24-mm beam collimation, and continuous scanning over 30 to 40 seconds to create a cine. RESULTS: Twelve patients (12%) had endoleaks that persisted or appeared more than 30 days post-deployment. Five patients in whom the standard CT surveillance protocol could not differentiate type II versus type III endoleaks underwent dynamic CTA. This technique accurately characterized the endoleaks and localized inflow and outflow branches to guide the subsequent successful secondary interventions. CONCLUSIONS: Dynamic CTA is a useful technique to evaluate endoleaks for characterization and precise localization to guide secondary interventional therapy.

Short-stay carotid endarterectomy in a tertiary-care Veterans Administration hospital.

BACKGROUND: This study focused on 200 carotid endarterectomies (CEA) performed at our Veterans Administration Hospital (VAH) to determine whether 1-day hospitalization after CEA is safe and the degree to which it can be achieved. METHODS: Over 36 months, 200 CEAs were performed for asymptomatic stenosis (n = 104), transient ischemic attacks (n = 68), and stroke (n = 28). General anesthesia was used in 189 procedures. RESULTS: The hospital stay was 1 day for 132 procedures and more than 1 day in 68 CEAs. The average stay was 1.69 +/- 1.5 days. After surgery there were 3 strokes, 5 hematomas that required evacuation, and 5 myocardial infarctions. There were no deaths. Four patients were readmitted in the 1-day and the greater than 1-day stay groups. History of myocardial infarction, renal insufficiency, longer operative time, and complications correlated with a greater than 1-day stay (P <0.05). CONCLUSION: A 1-day hospital stay is safe and practical in a VAH setting, resulting in good clinical outcomes.

The Ehlers-Danlos specter revisited.

Ehlers-Danlos type IV is a major concern to vascular surgeons because it is often associated with spontaneous hemorrhage from arteries containing decreased type III collagen. Five members of a family with Ehlers-Danlos type IV and a review of another family of five with Ehlers-Danlos type IV are reported. Evaluation of the recent family included clinical evaluation as well as assay of collagen production. The age range of the three involved females and two males was 7 to 52 years. The father of the affected family had a spontaneous colon perforation at age 39. His son, at age 27, had a spontaneous rupture of the iliac artery. Revascularization was accomplished with difficulty. His daughter had a large cerebral bleed. Two granddaughters, ages 7, have not had any bleeding or aneurysmal events. The amount of type III collagen was only 10% of normal in the patient with the iliac artery rupture. The three females all exhibited similarly low levels of type III collagen. The father's type III collagen level was not sufficiently low to confirm Ehlers-Danlos type IV, although he had a spontaneous colon perforation. In the other Ehlers-Danlos type IV family of five, the three surviving members had type III collagen levels as low as 5% of normal. Two family members died after spontaneous iliac rupture at ages 24 and 33. Both families exhibited an autosomal dominant inheritance pattern. Ehlers-Danlos type IV remains a challenging problem for vascular surgeons. It is transmitted as an autosomal dominant inheritance with a high degree of penetrance. Spontaneous arterial and intestinal perforations should alert the clinician to the possibility of Ehlers-Danlos type IV. Patients should be evaluated noninvasively. Arterial repairs may not be successful in these patients because the vessels are extremely friable. Assays of collagen production are advisable in establishing the diagnosis.

Acute postoperative pain management using massage as an adjuvant therapy: a randomized trial.

HYPOTHESIS: Adjuvant massage therapy improves pain management and postoperative anxiety among many patients who experience unrelieved postoperative pain. Pharmacologic interventions alone may not address all of the factors involved in the experience of pain. DESIGN: Randomized controlled trial. SETTING: Department of Veterans Affairs hospitals in Ann Arbor, Michigan, and Indianapolis, Indiana. PATIENTS: Six hundred five veterans (mean age, 64 years) undergoing major surgery from February 1, 2003, through January 31, 2005. INTERVENTIONS: Patients were assigned to the following 3 groups: (1) control (routine care), (2) individualized attention from a massage therapist (20 minutes), or (3) back massage by a massage therapist each evening for up to 5 postoperative days. Main Outcome Measure Short- and long-term (> 4 days) pain intensity, pain unpleasantness, and anxiety measured by visual analog scales. RESULTS: Compared with the control group, patients in the massage group experienced short-term (preintervention vs postintervention) decreases in pain intensity (P = .001), pain unpleasantness (P < .001), and anxiety (P = .007). In addition, patients in the massage group experienced a faster rate of decrease in pain intensity (P = .02) and unpleasantness (P = .01) during the first 4 postoperative days compared with the control group. There were no differences in the rates of decrease in long-term anxiety, length of stay, opiate use, or complications across the 3 groups. CONCLUSION: Massage is an effective and safe adjuvant therapy for the relief of acute postoperative pain in patients undergoing major operations.

Renal interventions after abdominal aortic aneurysm repair using an aortic endograft with suprarenal fixation.

BACKGROUND: Our aim was to determine whether suprarenal fixation in endografts compromises renal artery (RA) flow and whether subsequent RA intervention is precluded by the stent struts. METHODS: Prospectively acquired data from 104 patients with endovascular aneurysm repair (EVAR) of an abdominal aortic aneurysm using the Zenith endograft (Cook, Inc., Bloomington, IN) were analyzed. The Zenith device uses a 26-mm, uncovered, barbed Z stent for suprarenal function. RESULTS: No RA stenosis, occlusion, or infarction resulted from the suprarenal stent. In 3 of 104 (2.9%) patients, RA compromise (2 stenoses, 1 occlusion) was caused by impingement of graft material on the lowermost RA. The 2 RA stenoses were stented successfully at 1 and 7 months post-EVAR. Six of 104 (5.8%) patients developed late stenoses unrelated to the endograft: all were stented successfully from 19 to 36 months after EVAR. One patient with severe RA stenosis had balloon angioplasty pre-EVAR and then was stented electively 6 weeks post-EVAR. CONCLUSIONS: Our data show that the suprarenal fixation of the Zenith aortic endograft does not cause RA stenosis, occlusion, or infarction, nor does it preclude post-EVAR renal artery intervention.

Discretionary carotid patch angioplasty leads to good results.

BACKGROUND: This study evaluated the type and need for angioplasty in 253 consecutive carotid endarterectomies. METHODS: Polyester knitted gelatin sealed patch (DP) and polytetrafluoroethylene (PTFE) patches were used in, respectively, 159 and 29 patients, with 65 vessels closed primarily (no patch [NP]). RESULTS: Surgical results, estimated blood loss, and surgical time were similar in each group. Postoperative hematomas occurred in 6 DP and 3 NP patients. There were 3 strokes in the DP group. Long-term duplex evaluation was possible in 201 patients. The number of patients who had less than 15%, 15% to 50%, 50% to 79%, 80% to 99%, 100%, or an ungraded degree of narrowing were as follows for each group: DP, 117, 2, 5, 0, 1, and 2; PTFE, 18, 1, 1, 0, 0; and NP, 53, 0, 0, 0, 1. Statistical analysis failed to show any difference between groups postoperatively or in long-term follow-up evaluation. CONCLUSIONS: It appears that selective patching is safe and effective in male patients who undergo carotid endarterectomy. The type of patch material also is inconsequential. Patch type and its use should be at the surgeon's discretion.

Open surgical repair of children less than 13 years old with lower extremity vascular injury.

PURPOSE: We sought to review the diagnosis and treatment of children with lower extremity vascular injury. METHODS: We performed a query of our vascular surgery database from 1996 through 2002 to determine those with lower extremity vascular injuries requiring surgery who were also less than 13 years of age. Patient demographics, presentation, cause, surgical specifics, and outcome were sought. RESULTS: Six children (2 girls and 4 boys) with an average age of 6.8 years (range, 2-9 years) were found. The causes were 3 blunt injuries, 2 iatrogenic injuries, and 1 penetrating injury. Associated injuries were common. There were 3 femoral and 3 popliteal artery injuries. Two were pseudoaneurysms (common femoral and popliteal artery), and 4 were acute occlusions, of which 3 experienced a delay in diagnosis. There was one primary below-knee amputation. Four reverse vein bypasses were performed, and one vein patch repair of a pseudoaneurysm was performed. Generally, 7 to 9 O interrupted Prolene (Ethicon, Inc, Somerville, NJ) repairs were performed. A delay in diagnosis (2 blunt injuries) resulted in 2 major amputations and 1 insensate foot. Four reconstructions are functioning with viable limbs (follow-up, 5-49 months). An associated brain injury resulted in the only death. CONCLUSIONS: Vascular blunt injury is especially insidious in children. However, an aggressive approach of vascular repair, even extensive bypasses with reverse vein, will allow limb salvage in the absence of a diagnostic delay.