Society for Vascular Surgery femoral runoff score is associated with limb-based patency after aortofemoral bypass.

OBJECTIVE: Despite advancements, aortofemoral bypass (AFB) remains the most durable option for aortoiliac occlusive disease. Although runoff has been shown to be associated with AFB patency, the association of the Society for Vascular Surgery (SVS) thigh runoff scoring system with patency has not been assessed. The aim of the present study was to evaluate the association between the SVS runoff scoring system and limb-based primary patency after AFB. METHODS: Institutional data for patients undergoing AFB with preoperative runoff imaging available from 2000 to 2017 were queried. Runoff scores were assigned according to the presence of occlusive disease in the superficial femoral artery and profunda femoris artery (minimum, 1; maximum, 10) as described by the 1997 SVS reporting standards for lower extremity ischemia. Limb-based patency was the primary endpoint. Kaplan-Meier analysis was used to compare the long-term limb-based patency and freedom from reintervention between limbs with runoff scores ≥6 and those with runoff scores <6. Propensity score-weighted Cox proportional hazards modeling was used to evaluate the association between a runoff score of ≥6 and primary patency loss, controlling for other factors associated with primary patency. RESULTS: In 161 patients, 316 limbs had undergone revascularization. The mean patient age was 66.7 ± 11.3 years, and 51.6% were women. Most limbs had undergone revascularization for claudication (56.5%). Most (89.4%) had TransAtlantic InterSociety Consensus class D lesions, 27.3% had required suprarenal or higher clamping, and 11.2% had undergone concomitant mesenteric intervention. A femoral outflow adjunct and concurrent lower extremity bypass was required in 41.8% and 2.9% of limbs, respectively. Those with a runoff score of ≥6 had experienced greater rates of 30-day myocardial infarction (11% vs 1%; P = .005), respiratory failure (11% vs 1%; P = .005), and mortality (8% vs 0%; P ≤ .006). The median follow-up period was 4.0 years (interquartile range, 6.5 years). The 1-, 3-, and 5-year primary patency was 94.6% (95% confidence interval [CI], 91.9%-97.3%), 89.2% (95% CI, 85.4%-93.2%), and 81.4% (95% CI, 76.0%-87.1%), respectively. The 5-year primary-assisted patency, secondary patency, and freedom from reintervention were 84.9% (95% CI, 79.7%-90.5%), 91.7% (95% CI, 87.3%-96.3%), and 83.3% (95% CI, 78.3%-88.7%), respectively. Patients with a runoff score of ≥6 had lower primary (log-rank P < .01), primary-assisted (P < .01), and secondary patency (P = .01). The factors associated with the loss of primary patency included a high runoff score (runoff score of ≥6: hazard ratio [HR], 4.1; 95% CI, 2.1-8.0; P < .01), simultaneous mesenteric endarterectomy (HR, 13.5; 95% CI, 1.9-97.8; P = .01), and chronic kidney disease (HR, 4.6; 95% CI, 1.5-14.6; P = .01). Increasing age (HR, 0.94 per year; 95% CI, 0.91-0.97; P < .01) and hyperlipidemia (HR, 0.44; 95% CI, 0.23-0.85; P = .01) were protective. CONCLUSIONS: The SVS femoral runoff score is an important factor associated with long-term AFB limb patency. Scores of ≥6 portend for worse limb outcomes and a greater incidence of operative complications. The SVS score can be determined from preoperative axial imaging studies and serve as a guide in decision-making and operative planning.

Laparotomy- and groin-associated complications are common after aortofemoral bypass and contribute to reintervention.

BACKGROUND: Despite endovascular advancements, aortofemoral bypass (AFB; aortounifemoral and aortobifemoral bypass) remains the most durable option for aortoiliac occlusive disease. Whereas AFB reduces vascular aortoiliac reintervention, the impact of laparotomy-associated and groin wound complications on morbidity and reintervention is unclear. The aim of this study was to establish the incidence of nonvascular complications after AFB and to determine their effect on reintervention. METHODS: Institutional data for AFB (2000-2017) were queried. Primary end points included laparotomy-associated and groin wound complications. Total reintervention was defined as the composite outcome of reinterventions for laparotomy and groin wound complications and graft patency. Kaplan-Meier analysis estimated freedom from reintervention. Fine-Gray method for competing long-term risk determined predictors of laparotomy complications. Logistic regression, adjusting variability for patient-level clustering, determined predictors of wound complications. RESULTS: There were 553 limbs in 281 patients (272 aortobifemoral and 9 aortounifemoral bypasses; age, 67.6 ± 11.0 years; 50.5% female). Ninety (32%) patients had prior abdominal surgery, 3.2% had prior ventral hernia (VH) repair, 2.9% had untreated VH, and 0.7% had history of small bowel obstruction. The majority of patients underwent AFB for claudication (66.2%); 87.2% had TransAtlantic Inter-Society Consensus (TASC) D lesions, 31.4% required a suprarenal clamp or higher, 16.4% had concomitant renovisceral revascularization, and 6.4% were receiving anticoagulation. Sixty-seven (12.1%) limbs had redo femoral artery exposures, 32.4% required femoral outflow adjunct, and 1.8% had simultaneous lower extremity bypass. The 30-day mortality was 2.9%. During median follow-up of 5.3 years (interquartile range, 7.3 years), 21% had laparotomy complications (VH, 15.3%; small bowel obstruction, 7.5%; other, 2.1%), including 10.0% requiring operative intervention. Sixty-seven (12%) groins had a wound complication; 4.9% required intervention. Unadjusted 1-, 3-, and 5-year freedom from graft reintervention was 93.3% (95% confidence interval [CI], 90.1%-96.5%), 85.3% (80.7%-90.2%), and 79.6% (74.1%-85.5%), respectively. Freedom from total reintervention at 1 year, 3 years, and 5 years was 82.1% (95% CI, 77.4%-87.1%), 73.6% (68.0%-79.6%), and 65.1% (58.7%-72.2%). Predictors of laparotomy complications were untreated VH (P = .01) and hypertension (P = .01). Protective factors were thoracoabdominal approach (P < .01) and aortounifemoral bypass (P < .01). Predictors of wound complications included body mass index (per kg, 1.07; CI, 1.01-1.15; P = .018), anticoagulation (2.59; CI, 1.01-8.37; P = .049), and previous iliac stents (2.60; CI, 1.36-4.94; P = .004). CONCLUSIONS: Whereas AFB is a durable reconstruction with infrequent need for graft reintervention, laparotomy- and groin wound-associated complications contribute significantly to morbidity and reintervention after AFB. Predictive factors for laparotomy and groin wound complications should be considered in preoperative planning and selection of patients for AFB and in the discussion of outcomes.

Operative Complexity and Prior Endovascular Intervention Negatively Impact Morbidity after Aortobifemoral Bypass in the Modern Era.

BACKGROUND: Endovascular therapy is first-line treatment for aortoiliac occlusive disease. This shift has altered case volume, patient selection, and risk profile for aortobifemoral bypass (ABF). Given this, we sought to investigate factors influencing morbidity and mortality after ABF in the endovascular era. METHODS: Data for patients undergoing primary ABF from 2000 to 2017 were queried. Primary endpoints included major complication (unplanned return to the operating room, life-or-limb-threatening complications, and 30-day readmission or death) and long-term survival. Logistic regression and Cox proportional hazard models determined predictors of primary endpoints. Kaplan-Meier analysis estimated patency, freedom from reintervention, and long-term survival. RESULTS: During these 17 years, 256 patients underwent primary ABF. Mean age was 67.9 ± 10.6 years and 51.2% were women. Most had claudication (69.5%); 28.9% had critical ischemia. Sixty-five (25.4%) patients had prior aortoiliac endovascular intervention, 106 (41.4%) required aortic cuff endarterectomy, 111 (43.3%) femoral outflow adjunct, 9 (3.5%) simultaneous lower extremity bypass, and 230 (89.8%) had Trans-Atlantic Inter-Society Consensus D lesions. Concomitant renovisceral revascularization was needed in 42 (16.4%) patients. Thirty-day mortality was 2.7%. Major complication occurred in 92 patients (35.9%). Predictors included prior endovascular intervention (odds ratio [OR], 2.2; 95% confidence interval [CI]: 1.2-4.1; P = 0.01), malignancy (OR, 2.6; 95% CI: 1.3-5.3; P = 0.01), intraoperative complication (OR, 3.3; 95% CI: 1.3-9.2; P = 0.03), operative blood loss, (OR, 1.0 per 100 ml; 95% CI: 1.0-1.0; P = 0.03), and cuff endarterectomy (OR, 1.8; 95% CI: 1.0-3.1; P = 0.04). Median follow-up was 5.3 years (interquartile range: 7.2 years). Survival at 1, 3, and 5 years was 94%, 90%, and 82% respectively. Primary patency and freedom from reintervention at 5 years were 76% and 79%, respectively. Predictors of late mortality included malignancy (hazard ratio [HR], 2.3; 95% CI: 1.3-3.9; P < 0.01), chronic obstructive pulmonary disease (HR, 1.8; 95% CI: 1.1-3.1; P = 0.02), congestive heart failure (HR, 2.3; 95% CI: 1.2-4.3; P = 0.01), Rutherford's class (HR, 1.5; 95% CI: 1.1-2.1; P = 0.01), operative blood loss (HR 1.0 per 100 ml; 95% CI: 1.0-1.0; P = 0.04) and chronic kidney disease (HR, 2.3; 95% CI: 1.2-4.2; P = 0.01). CONCLUSIONS: Although late outcomes after ABF in the contemporary era remain acceptable, major complications are frequent. Operative complexity and prior endovascular revascularization predict complications. Long-term survival is driven by degree of limb ischemia and comorbidities. These should be considered in selection for ABF, potentially modifying approach to improve outcomes.

Retrograde stenting of proximal lesions with carotid endarterectomy increases risk.

OBJECTIVE: Concomitant carotid bifurcation and proximal ipsilateral arch branch disease is uncommon. A combined approach using carotid endarterectomy (CEA) with ipsilateral proximal endovascular (IPE) intervention (CEA+IPE) has been proposed as safe and durable, with similar results to isolated CEA. This study was conducted to identify diagnostic modalities and outcomes of this uncommon procedure at our institution. METHODS: Operative records were used to identify patients who underwent CEA+IPE between May 2003 and July 2014. Patients were excluded if they underwent open retrograde access for endovascular intervention only, without CEA. The primary end points were freedom from neurologic event and need for reintervention. RESULTS: Twenty-three patients (15 women [65%]) underwent CEA+IPE. Mean clinical follow-up was 44 ± 35 months. Average age was 69 ± 9 years. Most patients (22 [96%]) were taking a statin and at least one antiplatelet agent. Bilateral internal carotid stenosis (>50%) was present in 12 patients (52%), and eight (35%) were symptomatic. Seven patients (30%) had prior ipsilateral CEA. All patients underwent preoperative carotid duplex and axial imaging. Computed tomography angiography was the initial imaging assessment in 10 patients (43%). The proximal lesion was identified in 19 (83%) by blunted waveforms on carotid duplex. Most bifurcation operations were CEA with patch (20 [87%]), and 21 (91%) underwent the bifurcation procedure first, followed by IPE. All IPE included balloon-expandable stenting (22 of 23 [96%] bare-metal, 7 [30%] innominate artery, 16 [70%] left common carotid artery). Electroencephalographic changes occurred in two patients (9%). Shunting was used in three (13%). Three vessel dissections (13%) occurred at the IPE site; two required further stenting and one was complicated by stroke and death. There were two perioperative strokes (9%) and one death (4%). Mean imaging follow-up was 30.6. ± 27.2 months, with restenosis identified in five patients (23%; four bifurcation, one IPE in-stent). One patient required open reintervention with subclavian-carotid bypass at 13 months for recurrent transient ischemic attack. The 4-year actuarial survival was 85%. Stroke-free survival and freedom from reintervention were 80% and 90% at 36 months, respectively. CONCLUSIONS: The stroke and death rate for CEA+IPE is higher than that of isolated CEA at our institution. Duplex findings can suggest proximal stenosis; however, confirmation with physical examination in conjunction with axial imaging are integral. This combined treatment strategy should be reserved for those with evident hemodynamically significant proximal stenosis and approached with caution in asymptomatic patients.

Durability of open repair of juxtarenal abdominal aortic aneurysms.

OBJECTIVE: As branched/fenestrated endografts expand endovascular options for juxtarenal abdominal aortic aneurysms (JAAAs), long-term durability will be compared to that of open JAAA repair, which has not been documented in large contemporary series. The goal of this study was to assess the late clinical and anatomic outcomes after open JAAA repair. METHODS: From July 2001 to December 2007, 199 patients underwent open elective JAAA repair, as defined by a need for suprarenal clamping. End points included perioperative and late survival, long-term follow-up of renal function, and freedom from graft-related complications. Factors predictive of survival were determined by multivariate analysis. RESULTS: The mean patient age was 74 years, 71% were men, and 20% had baseline renal insufficiency (Cr >1.5). Thirty-seven renal artery bypasses, for anatomic necessity or ostial stenosis, were performed in 36 patients. Overall 30-day mortality was 2.5%. Four patients (2.0%) required early dialysis; one patient recovered by discharge. Two additional patients progressed to dialysis over long-term follow-up. There was one graft infection involving one limb of a bifurcated graft. Surveillance imaging was obtained in 101 patients (72% of survivors) at a mean follow-up of 41 ± 28 months. Renal artery occlusion occurred in four patients (3% of imaged renal arteries; one native/three grafts). Two patients (2.0%) had aneurysmal degeneration of the aorta either proximal or distal to the repaired segment, but there were no anastomotic pseudoaneurysms. Remote aneurysms were found in 29 patients (29% of imaged patients), 14 of whom had descending thoracic aneurysm or TAAA. Four patients underwent subsequent thoracic endovascular aneurysm repair (TEVAR). Actuarial survival was 74 ± 3.3% at 5 years. Negative predictors of survival included increasing age at the time of operation (relative risk [RR], 1.05; P = .01), steroid use (RR, 2.20; P = .001), and elevated preoperative creatinine (RR, 1.73; P = .02). CONCLUSIONS: Open JAAA repair yields excellent long-term anatomic durability and preserves renal function. Perioperative renal insufficiency occurs in 8.5% of patients, but few of them progress to dialysis. Graft-related complications are rare (2% at 40 months); however, axial imaging revealed descending thoracic aneurysms in 14% of imaged patients, making continued surveillance for remote aneurysms prudent. These data provide a benchmark against which fenestrated/branched endovascular aneurysm repair (EVAR) outcomes can be compared.

Continued favorable results with open surgical repair of type IV thoracoabdominal aortic aneurysms.

OBJECTIVES: Type IV thoracoabdominal aortic aneurysm (TAAA) repair, despite low risk of spinal cord ischemia (SCI), is reported to have significant morbidity and mortality. This has led some to apply adjuncts (eg, extracorporeal circulation) used in more extensive TAAA repair or to consider alternative approaches, such as hybrid operations. We have used a consistent, simplified surgical approach to type IV TAAA, and the goal of the present study is to review experience over 2 decades with such treatment and to identify correlates of surgical morbidity. METHODS: All type IV repairs at Massachusetts General Hospital from January 1989 through September 2009 were evaluated for clinical features, technical operative details, and 30-day outcomes. Logistic regression identified predictors of morbidity. Survival was assessed using Kaplan-Meier analysis. RESULTS: A total of 179 patients underwent type IV repair, with elective repair in 156 (87%) and urgent in 23 (13%). The clamp-and-sew technique was used for all operations, with routine hypothermic renal perfusion. Clinical features were age 73 ± 8 years, coronary artery disease in 89 (50%), and creatinine level >1.8 mg/dL defining chronic renal insufficiency (CRI) in 32 (18%). Operative reconstruction in 166 (93%) consisted of one beveled proximal anastomosis incorporating the descending thoracic aorta, celiac, superior mesenteric artery, and right renal arteries origins (mean visceral clamp time, 36 ± 12 minutes) and a side-arm graft to the left renal artery. Technical details included previous abdominal aortic aneurysm (AAA) repair in 52 (29%), operative time of 290 ± 90 min, estimated blood loss of 2.7 ± 1.4 L, and splenectomy in 57 (32%). The 30-day outcomes were death in 5 (2.8%), myocardial infarction in 6 (3.4%), hemodialysis in 5 (2.8%), and any degree of SCI in 4 (2.2%). Regression analysis identified a history of CRI as an independent predictor of postoperative complication or death (odds ratio, 3.4; 95% confidence interval, 1.4-8). Survival rates at 1, 5, and 10 years were 89% ± 2%, 62% ± 4%, and 36% ± 5%, respectively. CONCLUSIONS: A simplified operative approach for type IV TAAA repair is associated with favorable perioperative results. These data refute the need for surgical adjuncts commonly applied in more extensive TAAA and indicate that the hybrid operation is an illogical posture. CRI should figure prominently in clinical decision making. Long-term survival equates that observed after routine AAA repair.

Comparable mortality with open repair of complex and infrarenal aortic aneurysm.

BACKGROUND: A consequence of endovascular aneurysm repair (EVAR) of anatomically straightforward infrarenal abdominal aortic aneurysm repair cohort (AAA) is that open aneurysm repair is more commonly performed for complex anatomy. Complex aneurysm repair with visceral vessel involvement (CAA) or combined aneurysm repair and visceral vessel reconstruction (VVR) has traditionally been considered to increase morbidity and mortality compared with repair of infrarenal AAA. This study evaluated contemporary outcomes of open abdominal aneurysm surgery, including AAA, CAA, and VVR using the National Surgical Quality Improvement Program (NSQIP) database. METHODS: The NSQIP Participant Use File was queried by CPT code to identify patients undergoing AAA, CAA, and VVR (2005-2008). Comparative analysis of clinical features, technical details and 30-day outcomes was performed using univariate methods. Logistic regression analysis was used to identify predictors of morbidity and mortality. RESULTS: A total of 2820 patients underwent AAA and 592 CAA. Renal insufficiency (ie, creatinine >1.4 mg/dL) rates were similar in AAA and CAA patients, however, more frequent in patients with VVR (51% vs 31% [no bypass]; P < .01). CAA was less likely to be performed urgently (6.3% vs 9.1%; P < .05) and was associated with increased operative time (254 ± 100 vs 224 ± 93; P < .01) compared with AAA. Univariate analysis showed that CAA did not increase mortality (5.7% vs 5.1%; P = .5). CAA slightly increased overall complications (32% vs 27%; P = .01) compared with AAA. 73 (2.5%) AAA and 84 (12%) CAA patients had simultaneous VVR and these patients exhibited a trend toward increased mortality (8.9% vs 5.2%; P = .07). VVR increased complications (43% (VVR) vs 26% [no bypass]; P < .01), including ventilation >48 hours (21% [VVR] vs 12% [no bypass]; P < .01), renal failure (7.6% [VVR] vs 4.1% [no bypass]; P = .04), and sepsis (13% [VVR] vs 6.3% ([no bypass]; P < .01). Multivariate analysis demonstrated that CAA (odds ratio [OR], 1.3 [95% confidence interval (CI), 1.1-1.6]; P = .01) and VVR (OR, 2.2 [95% CI, 1.8-3.6]; P < .01) increased the odds of any complication. Independent predictors of mortality included dependent functional status (OR, 3.6 [95% CI, 2.3-5.4]; P < .01), elevated pre-op creatinine (OR, 2.9 [95% CI, 2.2-4.0]; P < .01), type II diabetes (OR, 1.6 [95% CI, 1.05-2.4]; P = .03), and age (OR, 1.06 [95% CI, 1.03-1.08]; P < .01). Neither CAA (OR, 1.2 [95% CI, 0.84-1.8]; P = .3) nor VVR (OR, 1.6 [95% CI, 0.89-2.9]; P = .11) were associated with increased mortality compared with AAA. CONCLUSION: In contemporary practice the migration of open repair to increasingly complex cases has been achieved with 30-day mortality essentially equivalent to open repair of infrarenal AAA. Patients who require VVR do sustain increased complications, in particular renal failure. These data also emphasize the importance of baseline renal insufficiency in clinical decision making. CAA and VVR are associated with increased morbidity in comparison to AAA repair; however, both procedures can be safely performed in patients without increased risk of operative mortality.

Preoperative variables predict persistent type 2 endoleak after endovascular aneurysm repair.

OBJECTIVE: Persistent type 2 endoleaks (PT2, present >or=6 months) after endovascular aneurysm repair (EVAR) are associated with adverse outcomes. This study evaluated the preoperative risk factors and natural history of PT2 in order to define a population at high risk. METHODS: From January 1999 to December 2007, 595 of 832 EVAR patients had long-term computed tomography follow-up and comprised the study cohort. Preoperative anatomic and clinical variables were correlated with PT2 using Cox regression. Composite hazard ratios (HRs) were constructed with clusters of high-risk preoperative variables. Primary end points, including spontaneous resolution, sac enlargement >5 mm, and freedom from reintervention, were evaluated using Kaplan-Meier analysis. RESULTS: There were 136 PT2 patients (23%) with a median follow-up of 34.8 months (range, 6.4-121.2 months). Positive predictive factors included patent inferior mesenteric artery (IMA; HR, 4.00; 95% confidence interval [CI], 1.62-9.90; P = .003), increasing number of patent lumbar arteries (HR, 1.24; 95% CI, 1.10-1.41; P = .0006), increasing age (HR, 1.04; 95% CI, 1.01-1.06; P = .005), and increasing luminal diameter on CT-contrast opacified lumen (HR, 1.03; 95% CI, 1.02-1.05; P = .0001). During follow-up, spontaneous PT2 resolution occurred in 34 patients (25%), sac diameter remained stable in 63 (46%), and rupture occurred in 2 (1.5%). Kaplan-Meier analysis estimated that 35.2% +/- 5.6% (95% CI, 23.8%-46.2%) of PT2 resolve spontaneously at 5 years after the index procedure. Freedom from sac enlargement >5 mm was 54.6% +/- 7.2% (95% CI, 40.6%-69.4%) at 5 years. Fifty-nine reinterventions were performed in 39 patients with PT2. Freedom from reintervention was 67.3% +/- 5.0% (95% CI, 57.0%-77.0%) at 5 years. The combination of a patent IMA and one risk factor of more than six patent lumbar arteries, maximum luminal diameter >30 mm, or age >70 years increased the odds of PT2 approximately ninefold. The combination of a patent IMA and any two risk factors increased the odds of PT2 approximately 18-fold. CONCLUSIONS: Several readily identifiable preoperative variables are associated with PT2 whose natural history was benign in but 35% of patients. On the basis of the composite high-risk HRs, there is accordingly a cohort of patients in whom perioperative interventions to preclude PT2 should be considered.

Secondary intervention after endovascular abdominal aortic aneurysm repair.

OBJECTIVE: Endovascular Abdominal Aortic Aneurysm Repair (EVAR) has been criticized because of the need for frequent secondary interventions (2ndINT) to maintain effective abdominal aortic aneurysm (AAA) exclusion. The study goal is to detail such interventions and determine their effect on clinical outcomes. METHODS: From January 1997 to December 2007, 832 patients underwent EVAR. Those requiring 2ndINT were stratified according to the indications and specific nature of 2ndINT and treatment. Study endpoints included freedom from 2ndINT, aneurysm-related and overall survival. RESULTS: There were 91 (11%) patients who underwent 131 2ndINT (mean follow-up 35 months). No demographic features (age, gender, etc) predicted the need for 2ndINT. Actuarial 5-year freedom from 2ndINT was 80%. Indications for 2ndINT included: sac rupture 5 (4%), graft migration/ type I endoleak 37 (28%), persistent type II endoleak 40 (38%), endotension with sac growth 5 (4%), and limb occlusion/kinking 24 (18%). The majority of 2ndINT were accomplished with an endovascular approach (76%) with a >80% initial success rate for all indications except type II endoleak in which the initial intervention was successful only 34% of the time. Initial 2ndINT were successful in 62% and 35 (38%) patients underwent more than one 2ndINT. Multivariate predictors of 2ndINT were AAA sac size >5.5cm (OR = 2.1, P = 0.004), and preprocedure coil embolization (hypogastric or inferior mesenteric artery) (OR = 2.1, P = 0.008). The actuarial survival was 70% at 5 years and the aneurysm-related survival was 97.5% with no difference in either parameter in patients who underwent 2ndINT compared with those who did not. CONCLUSIONS: Although 2ndINT are common after EVAR, most were addressed through an endovascular approach; technical success thereof varies widely with the specific indication for 2ndINT. Secondary intervention did not adversely affect aneurysm-related or overall actuarial 5-year survival.

Aortic remodeling after endovascular repair of acute complicated type B aortic dissection.

OBJECTIVE: The role of thoracic endovascular aortic repair (TEVAR) in the management of acute type B aortic dissection remains undefined. Entry tear coverage during the acute phase is an appealing method to treat acute complications, and by inducing false lumen thrombosis, might also prevent late aneurysm formation. This study evaluated structural changes by serial computed tomography (CT) in the thoracic aorta after TEVAR performed for acute complicated aortic dissection. METHODS: Between August 2005 and October 2007, 33 patients with complicated acute type B aortic dissection were treated with TEVAR (19 from a prospective industry sponsored trial, 14 from our institution). CT images obtained preprocedurally (PP), at 1 month (1M), and 1 year (1Y) were evaluated for each patient. Four patients with no postprocedural imaging were excluded. The largest diameters of the thoracic aorta, dissection true lumen, and false lumen were recorded at each time point. Changes in total aortic and true and false lumen diameters were evaluated using a mixed effect analysis of variance model of repeated measures. RESULTS: The average age was 58 years (range, 38-87 years); 26 (81%) were male. Indications for TEVAR included malperfusion syndrome in 17 (53%), refractory hypertension in 14 (44%), impending rupture in 12 (28%), and refractory pain in 14 (44%); 19 (59%) had more than one indication. The average length of aorta covered was 19.5 cm (range, 10-29.3 cm). The maximum aortic diameter decreased over time (P = .04) and averaged 39.9 (PP), 41.3 (1M), and 34.8 mm (1Y). The true lumen diameter increased over time (P = .02) and averaged 23.7 (PP), 29.0 (1M), and 31.1 mm (1Y). The false lumen diameter decreased (P = .046) and averaged 19.5 (PP), 12.1 (1M), and 9.6 mm (1Y). Partial or complete thrombosis of the false lumen along the stented segment of aorta was recorded in 87% (PP), 93% (1M), and 88% (1Y). CONCLUSIONS: TEVAR of acute complicated aortic dissection appears to promote early aortic remodeling. Nearly 90% of patients maintained at least partial false lumen thrombosis at 1 year. Because continued false lumen patency correlates strongly with late aneurysm formation, such favorable remodeling is considered a surrogate for prevention of late aneurysm, but longer follow-up is required.

Infrapopliteal balloon angioplasty for the treatment of chronic occlusive disease.

OBJECTIVE: There is little documentation of the effectiveness of percutaneous balloon angioplasty (PTA) of infrapopliteal vessels for the treatment of chronic lower extremity ischemia. This study reviewed our recent experience with infrapopliteal PTA in a large series of patients to determine its effectiveness as a treatment modality. METHODS: All patients undergoing primary infrapopliteal PTA from March 2002 to June 2006 were included. Primary study end points were primary patency, assisted patency, limb salvage, and patient survival assessed by Kaplan-Meier life-table analysis. Factors predictive of PTA failure and patient longevity were evaluated by multivariate methods. RESULTS: There were 155 PTAs undertaken in 144 patients (70% men; mean age, 74 years), with critical limb ischemia (86%), diabetes (66%), and renal insufficiency (45%). Infrapopliteal lesions were classified as TransAtlantic Inter-Society Consensus A (7%), B (18%), C (39%), and D (35%). PTA was confined to the infrapopliteal segment in 40 (26%), and 115 (74%) underwent multilevel treatment. Five patients (3%) received stents. Technical success was 95%. The 30-day mortality was 2%, and major morbidity was 3%. The mean follow-up was 22 months (range, 0-54 months). The 40-month actuarial primary patency was 62% (standard error, 5%), with assisted patency (infrapopliteal re-PTA, 25 [16%]) of 90%. Interval conversion to bypass surgery occurred in seven (5%). Nonhealing ulcers occurred in 118 patients (76%), of which 76 (64%) healed during follow-up. Of the 42 unhealed ulcers, 15 (13%) required major amputations for a 40-month limb salvage of 86.2%. Multivariate predictors that were negative for primary patency included 0/1 vessel runoff (P = .01), critical limb ischemia (P = .002), and dialysis (P = .03). Negative predictors of limb salvage included dialysis (P = .007) and failure to improve runoff to the foot (P = .006). At 40-months, patient survival was 54%, with negative predictors including severe pulmonary disease (P = .01), coronary artery disease (P = .04), and renal insufficiency (P < .001). CONCLUSIONS: Infrapopliteal angioplasty can be performed safely with favorable results in patients with limited longevity. Primary patency is related to disease extent. Secondary interventions may be necessary to maintain clinical success. These data indicate that PTA should be considered as initial therapy for infrapopliteal occlusive disease in patients with lower extremity ischemia.

Endovascular stenting of a penetrating axillary artery injury in a 14-year-old with 1-year follow-up.

In the management of pediatric trauma, certain principles that are practiced in children who have sustained injuries more commonly seen in adults are extrapolated from the adult trauma literature. The increased use of computer tomography angiograms in the diagnosis of penetrating vascular trauma and endovascular therapy in treating vascular trauma in the adult population is being extended to the pediatric population. We present a case of a 14-year-old male with an axillary artery injury that was diagnosed by computer tomography angiogram and treated with an endovascular Stent graft with 1-year follow-up.

Outcomes following endovascular abdominal aortic aneurysm repair (EVAR): an anatomic and device-specific analysis.

OBJECTIVE: We performed a device-specific comparison of long-term outcomes following endovascular abdominal aortic aneurysm repair (EVAR) to determine the effect(s) of device type on early and late clinical outcomes. In addition, the impact of performing EVAR both within and outside of specific instructions for use (IFU) for each device was examined. METHODS: Between January 8, 1999 and December 31, 2005, 565 patients underwent EVAR utilizing one of three commercially available stent graft devices. Study outcomes included perioperative (< or =30 days) mortality, intraoperative technical complications and need for adjunctive procedures, aneurysm rupture, aneurysm-related mortality, conversion to open repair, reintervention, development and/or resolution of endoleak, device related adverse events (migration, thrombosis, or kinking), and a combined endpoint of any graft-related adverse event (GRAE). Study outcomes were correlated by aneurysm morphology that was within or outside of the recommended device IFU. chi2 and Kaplan Meier methods were used for analysis. RESULTS: Grafts implanted included 177 Cook Zenith (CZ, 31%), 111 Gore Excluder (GE, 20%), and 277 Medtronic AneuRx (MA, 49%); 39.3% of grafts were placed outside of at least one IFU parameter. Mean follow-up was 30 +/- 21 months and was shorter for CZ (20 months CZ vs 35 and 31 months for GE and MA, respectively; P < .001). Overall actuarial 5-year freedom from aneurysm-related death, reintervention, and GRAE was similar among devices. CZ had a lower number of graft migration events (0 CZ vs 1 GE and 9 MA); however, there was no difference between devices on actuarial analysis. Combined GRAE was lowest for CZ (29% CZ, 35% GE, and 43% MA; P = .01). Graft placement outside of IFU was associated with similar 5-year freedom from aneurysm-related death, migration, and reintervention (P > .05), but a lower freedom from GRAE (74% outside IFU vs 86% within IFU; P = .021), likely related to a higher incidence of graft thrombosis (2.3% outside IFU vs 0.3% within IFU; P = .026). The differences in outcome for grafts placed within vs outside IFU were not device-specific. CONCLUSION: EVAR performed with three commercially available devices provided similar clinically relevant outcomes at 5 years, although no graft migration occurred with a suprarenal fixation device. As anticipated, application outside of anatomically specific IFU variables had an incremental negative effect on late results, indicating that adherence to such IFU guidelines is appropriate clinical practice.

Five-year report of a multicenter controlled clinical trial of open versus endovascular treatment of abdominal aortic aneurysms.

OBJECTIVE: Compare long-term results of endovascular treatment and standard open repair of abdominal aortic aneurysms in a multicenter, concurrent-controlled trial. METHODS: 334 subjects were treated with standard open repair (control, n = 99) or the original EXCLUDER Bifurcated Endoprosthesis (test, n = 235). Five-year clinical evaluations and corelab radiographic results are analyzed. RESULTS: Overall and aneurysm-related survival are similar. There have been ten open conversions, most frequently for enlarging sacs without endoleak. Two patients died after conversion. Including reinterventions and complications of reinterventions as adverse events, there is significant, persistent long-term reduction in major adverse events. At 5 years, corelab reported 0% limb narrowing, 0% trunk migration, 0% component (contralateral leg, aortic extender, and iliac extender) migration, 0% fracture, endoleak in 3% (2 type II/68), and aneurysm growth (>5 mm compared to baseline) in 38% (30/78) of the test group. There are no aneurysm ruptures in either test or control group. CONCLUSIONS: After 5 years follow-up, endovascular repair is a safer and effective treatment compared with open surgical repair for abdominal aortic aneurysms. Major adverse events are less frequent with the endograft despite the need for late reinterventions. Aneurysm expansion is observed in nearly two-fifths of patients but is not associated with endoleak or aneurysm rupture. Multicenter clinical trials are evaluating a newer version of this device designed to avoid this high rate of sac expansion.

Surgical revascularization versus endovascular therapy for chronic mesenteric ischemia: a comparative experience.

INTRODUCTION: Endovascular therapy (percutaneous transluminal angioplasty [PTA] with stenting) has been increasingly applied in patients with chronic mesenteric ischemia (CMI) to avoid morbidities associated with open repair (OR). The purpose of this study was to compare outcomes of PTA/Stent vs OR in patients with symptomatic CMI. METHODS: During the interval of January 1991 to December 2005, 80 consecutive patients presenting with symptomatic CMI underwent elective revascularization. Patients with acute mesenteric ischemia or those with mesenteric revascularization performed as part of complex aneurysm repair were excluded. PTA/Stent (with stenting in 87%) was the initial procedure in 31 patients (42 vessels). OR was performed in 49 patients (88 vessels) and consisted of bypass grafting in 31 (63%), transaortic endarterectomy in 7 (14%), patch angioplasty in 4 (8%), or combined in 7 (15%). Mean follow-up was 15 months in the PTA/Stent group and 42 months in the OR cohort. Study end points included perioperative morbidity, mortality, late survival (Kaplan-Meier), and symptomatic and radiographic recurrence. RESULTS: Baseline comorbidities, with the exception of heart disease (P=.025) and serum albumin<3.5 g/dL (P=.025), were similar between PTA/Stent and OR patients. The PTA/Stent group had fewer vessels revascularized (1.5 vs 1.8 vessels, P=.001). Hospital length of stay was less for the PTA/Stent group (5.6 vs 16.7 days, P=.001). No difference was noted in in-hospital major morbidity (4/31 vs 2/49, P=.23) or mortality (1/31 vs 1/49, P=.74). Actuarial survival at 2 years was similar between the groups (88% PTA/Stent vs 74% OR, P=.28). There was no difference in the incidence of symptomatic (7/31 [23%] vs 11/49 [22%], P=.98) or radiographic recurrence (10/31 [32%] vs 18/49 [37%], P=.40) between the two groups. Radiographic primary patency (58% vs 90%, P=.001) and primary assisted patency (65% vs 96%, P<.001) at 1 year were lower in the PTA/Stent group compared with OR. Five (16%) of 31 PTA/Stent patients compared with 11 (22%) of 49 OR patients required a second intervention on at least one index vessel at any time (P=.49). CONCLUSIONS: Symptomatic recurrence requiring reintervention is common (overall 16/80 [20%]) after open and endovascular treatment for CMI. PTA/Stent was associated with decreased primary patency, primary assisted patency, and the need for earlier reintervention. In-hospital mortality or major morbidity were similar in patients undergoing PTA/Stent and OR. These findings suggest that OR and PTA/Stent should be applied selectively in CMI patients in accordance with individual patient anatomic and comorbidity considerations.