Peter H. Connolly

Midterm outcomes after treatment of type II endoleaks associated with aneurysm sac expansion

Purpose To examine the outcomes following interventions for type II endoleaks in patients with aneurysm sac expansion after endovascular aneurysm repair (EVAR). Methods A retrospective review was conducted of all patients who underwent treatment for type II endoleak from July 2001 to September 2010 in a single center. In this time period, 29 (4.7%) patients (22 men; mean age 78.6 years, range 54–87) were identified as having a type II endoleak and enlargement of the aneurysm sac, meeting the criterion for treatment. All patients had at least one attempted percutaneous intervention. Patients were followed both clinically and radiographically, with computed tomographic angiography every 3 to 12 months, over a follow-up period that ranged from 1 to 10 years (mean 3.5). Results Forty-eight interventions were performed on the 29 patients. Of these, 15 (56%) patients underwent multiple (2–4) procedures. Of the 11 endoleaks with an isolated inferior mesenteric artery identified as the source, initial success for transarterial embolization at 2 years was 72%, with 2 of the failures having successful secondary interventions. For the 18 endoleaks with a lumbar source, the success of the initial intervention was 17% at 2 years; repeated embolization attempts produced a 40% secondary success rate. Seven (24%) patients had continued endoleak despite multiple treatment attempts; 3 ultimately required elective aortic graft explantation. There were no ruptures or deaths during the study period. In a comparison of type II endoleak patients who had stable aneurysm sacs and those who had persistent sac expansion, the only significant differences in preoperative anatomical characteristics were a lower prevalence of mural thrombus (p=0.036) and longer right iliac arteries (p=0.012) in the group with sac expansion. Independent predictors of type II endoleak were mural thrombus (p<0.001), patent lumbar arteries (p=0.004), aneurysm length (p=0.011), and iliac artery length (p=0.004) Conclusion This study demonstrates that most patients require multiple reinterventions to treat type II endoleaks; specifically, lumbar artery embolization carries a low midterm success rate.

The Comprehensive Risk Assessment for Bypass (CRAB) facilitates efficient perioperative risk assessment for patients with critical limb ischemia

OBJECTIVE Specific perioperative risk assessment models have been developed for bariatric, pancreatic, and colorectal surgery. A similar instrument, specific for patients with critical limb ischemia (CLI), could improve patient-centered clinical decision making. We describe a novel tool to predict 30-day major morbidity and mortality (M&M) after bypass surgery for CLI. METHODS Data for 4985 individuals from the 2007 to 2009 National Surgical Quality Improvement Program were used to develop and internally validate the model. Outcome measures included mortality, major morbidity, and a composite end point (M&M). M&M included mortality and the most severe postoperative morbidities that were highly associated with death (eg, sepsis and major cardiopulmonary complications). More than 30 preoperative factors were tested for association with 30-day mortality, major morbidity, and M&M. Significant predictors in multivariate models were assigned integer values (points), which were added to calculate a patients Comprehensive Risk Assessment For Bypass (CRAB) score. Performance was assessed (C-index) across all outcome measures and compared with other general tools (American Society of Anesthesiologists class, Surgical Risk Scale) and existing CLI-specific survival prediction models (Finnvasc score, Edifoligide for the Prevention of Infrainguinal Vein Graft Failure [PREVENT III] score) on a distinct validation sample (n = 1620). RESULTS In the derivation data set (n = 3275), the 30-day mortality rate was 2.9%. The rate of any major morbidity was 19.1%. The composite end point M&M occurred in 10.1%. Significant predictors of M&M by multivariate analysis included age >75 years, prior amputation or revascularization, tissue loss, dialysis dependence, severe cardiac disease, emergency operation, and functional dependence. Applied to a distinct validation sample of 1620 patients, higher CRAB scores were significantly associated with higher rates of mortality, all major morbidities, and M&M (P < .0001). Comparison with other models by assessment of area under the receiver-operating characteristic curve revealed the CRAB was a more accurate predictor of mortality, all major morbidity, and M&M. CONCLUSIONS The CRAB is a CLI-specific, risk assessment instrument derived from multi-institutional American College of Surgeons-National Surgical Quality Improvement Program surgical outcomes data that out-performs existing prognostic risk indices in the prediction of clinically significant adverse events after bypass surgery. Use of the CRAB as a risk assessment tool provides an evidence basis for patient-centered clinical decision making and may have a role in identifying patients at higher risk for surgical revascularization in whom an endovascular approach is preferable.

Endovascular management as first therapy for chronic total occlusion of the lower extremity arteries: comparison of balloon angioplasty, stenting, and directional atherectomy.

Purpose To evaluate the role of endovascular therapy in the management of infrainguinal arterial chronic total occlusions (CTOs). Methods Data on all patients with CTOs treated at a single center from 2004 to 2010 were extracted from a prospectively maintained database for retrospective analysis. Patient demographics, angiographic studies, noninvasive vascular test results, and clinical outcomes were evaluated. In this time frame, 481 patients (283 men; mean age 71.7±11.5 years, range 52–85) with claudication (n=177) or critical limb ischemia (CLI, n=304) were treated for 688 CTOs. Lesions were segregated according to location [SFA (n=193), popliteal (n=67), tibial (n=217), and multilevel (n=211)] and analyzed based on treatment mode (angioplasty, angioplasty with stenting, or atherectomy) and clinical indication. Primary patency, assisted primary patency, and secondary patency, as well as limb salvage rates for CLI patients, were calculated. Results At 2 years in claudicants with CTOs confined to the SFA, primary patency ranged from 44% to 58% and secondary patency to 92% depending on treatment type; there were no significant differences among the treatments. However, in CLI patients with SFA CTOs, atherectomy produced better outcomes at 2 years (p=0.002 for primary and p=0.012 for secondary patency) than angioplasty alone. The limb salvage rates ranged from 73% to 91% (no differences among treatment types). In diabetics, CTOs treated with angioplasty and stent had improved secondary patency rates over angioplasty alone. Conclusion The endovascular management of CTO results in reasonable primary patency; moreover, secondary patency at 2 years is excellent. Endovascular therapy should be the first-line option for many patients with peripheral artery disease, including those with CLI, claudicants with poor bypass conduit, or patients at high medical risk for surgery. The presence of CTOs does not appear to change these recommendations. Although multiple reinterventions may be required, endovascular therapies can be considered a primary therapy for many patients with CTO.

Clinical, demographic, and medicolegal factors associated with geographic variation in inferior vena cava filter utilization: An interstate analysis

OBJECTIVES Geographic variability exists in the use of IVC filters (IVCF). We hypothesized that variation in IVCF use is incompletely explained by variation in the prevalence of deep-vein thrombosis (DVT) and pulmonary embolism (PE) and may result from different practice patterns regarding prophylactic IVCF use. We characterize geographic variation in IVCF use at the state level and evaluate its association with clinical factors, patient demographics, and the medicolegal environment. METHODS Healthcare Cost and Utilization Project State Inpatient Database records were accessed to identify 230,445 IVCFs placed from 2006 to 2008 in 33 states. Similar queries were performed for DVT and PE. Additional state data were obtained from public sources. Analyses included descriptive statistics, Spearman Correlation (SC), Wilcoxon rank-sum test, and characterization of variability. RESULTS Overall, IVCF use correlated with the prevalence of DVT (SC = 0.89, P < .01). States on the East coast have significantly greater rates of IVCF use per 100K (mean ± SD = 41.2 ± 16.7 vs 27.8 ± 11.1, P < .05) and greater rates of IVCF per DVT (20.2 ± 4.5% vs 15.2 ± 2.9%; P < .005), despite similar rates of DVT per 100K (198.1 ± 51.2 vs 177.7 ± 46.7, P = NS) compared with all other states. Overall, states with the greatest rate of IVCF per DVT were (in descending order): Rhode Island, New Jersey, Florida, New York, and West Virginia. Rates of detected PE per 100K in these states were not significantly different from all other states (95.6 ± 16.6 vs 90.4 ± 16.1, P = NS). In these states, a greater percentage of IVCF recipients were older than 85 (15.3% vs 11.8%; P < .01); fewer were pediatric (0.3% vs 0.7%; P < .05) or aged 45 to 64 (26.1% vs 32.4%; P < .001). There were no differences in patient sex, race, insurance type, hospital size, or teaching status. States with high rates of IVCF per DVT were noted to have significantly greater rates of paid malpractice claims per 100K (4.9 ± 2.51 vs 1.1 ± 0.8; P = .001), and annual general surgeon liability insurance premiums (

Assessing the Perioperative Safety of Common Femoral Endarterectomy in the Endovascular Era

78,630 ± 34,822 vs

Risk Factors for Protracted Postoperative Length of Stay after Lower Extremity Bypass for Critical Limb Ischemia

43,989 ± 17,794; P < .05). CONCLUSION Variation in IVCF use is incompletely explained by clinical factors. High rates of IVCF per DVT in some states may represent increased use of prophylactic IVCF in states with litigious medicolegal environments.

Gender differences in outcomes of endovascular treatment of infrainguinal peripheral artery disease

Introduction: Common femoral endarterectomy (CFE) has historically been the preferred treatment for atherosclerotic lesions involving the common femoral artery. The objectives of this study are to delineate the safety of this open procedure in the endovascular era, establish contemporary benchmarks for morbidity and mortality after CFE, and identify the subgroup of patients at increased risk of postoperative adverse events. Methods: Patients undergoing elective CFE in the 2007 to 2010 National Surgical Quality Improvement Project database were examined. Univariate analyses were used to identify the factors associated with major morbidity and mortality. Significant variables by univariate analysis were used to create multivariate logistic regression models for morbidity and mortality. Results: A total of 1513 patients underwent elective CFE. The 30-day mortality rate was 1.5%. Postoperative morbidities included cardiac (1.0%), pulmonary (1.9%), renal (0.4%), urinary tract infection (1.7%), thromboembolic (0.5%), neurologic (0.4%), sepsis (2.7%), superficial (6.3%), and deep surgical site complications (2.0%). At least 1 complication, including major and minor, was seen in 7.9% of the patients. By multivariate analysis, partial- and total-dependent functional status (odds ratio [OR] 9.0, 95% confidence interval [CI] 2.8-28.4 and OR 21.3, 95% CI 3.3-139.4) and dyspnea at rest (OR 8.2, 95% 1.2-58.8) predicted mortality. Independent predictors of morbidity include steroid use (OR 2.4, 95% 1.4-4.1), diabetes (OR 1.8, 95% CI 1.3-2.4), and obesity (OR 1.6, 95% CI 1.1-2.4). Discussion: Overall, CFE is tolerated well by the majority of patients with peripheral arterial disease. These results affirm the safety of CFE and can still be used as standard first-line therapy in most patients. Long-term results for endovascular interventions need to be studied to see whether high-risk patients that we identified for CFE would benefit more from an endovascular approach.

Heart failure is associated with reduced patency after endovascular intervention for symptomatic peripheral arterial disease

BACKGROUND Compared with other common chronic conditions, admissions for management of peripheral arterial disease (PAD) are associated with prolonged hospitalizations. Length of stay (LOS) is one of many metrics receiving increased attention in the current focus on efficient healthcare delivery. Our objective was to characterize LOS among patients with severe PAD, those undergoing surgical bypass for critical limb ischemia (CLI), and identify risk factors for protracted postoperative LOS. METHODS Patient data from the 2007 to 2009 American College of Surgeons National Surgical Quality Improvement Program were used to develop a database consisting of patients undergoing bypass surgery for CLI (n = 4,894). Protracted postoperative LOS was defined as the top quartile of days hospitalized from surgery to discharge. Preoperative risk factors with significant association (Pearson chi-squared test; P < 0.05) were used to develop a logistic regression model for protracted postoperative LOS. RESULTS Average postoperative LOS was 7.5 days (median 6 days). The top quartile of postoperative LOS, >8 days, was used to define protracted LOS. Independent preoperative risk factors for protracted postoperative LOS included demographic characteristics (advanced age and non-Caucasian race), comorbidities, and medical history (e.g., obesity, dialysis dependence, severe cardiac and pulmonary disease, and bleeding disorders). Indicators of PAD severity (e.g., distal target sites, open wounds or gangrene, and prior arterial surgery) were also independent predictors of protracted LOS after surgery. The greatest predictors of extended postoperative LOS were prolonged preoperative hospitalization (OR 2.2 [95% CI: 1.8-2.6], P < 0.001) and preoperative dependent functional status (OR 2.0 [95% CI: 1.7-2.3], P < 0.001 for partial dependence; OR 2.8 [95% CI: 1.8-4.3], P < 0.001 for totally dependent status), where OR and CI stand for odds ratio and confidence interval. CONCLUSIONS Here, we identify preoperative risk factors for protracted postoperative LOS after infrainguinal bypass for CLI. These findings provide an important evidence basis for ongoing efforts to reduce healthcare spending and facilitate provision of efficient health care. Future efforts will include prospective identification of patients at high risk for protracted postoperative LOS and targeted multidisciplinary efforts to reduce associated costs without sacrificing healthcare quality.

Variability in anesthetic considerations for arteriovenous fistula creation.

Objective: Our goal was to assess the outcomes of females compared to males treated with endovascular lower extremity interventions in order to determine optimal therapy based on gender. Methods: We performed a retrospective review evaluating the outcomes of primary transluminal angioplasty (PTA) and PTA + stenting (PTA + S) for peripheral arterial disease (PAD). Patency rates and limb salvage were the primary end points. Results: A total of 1017 lesions were analyzed in 537 patients (229 male and 308 female) between 2004 and 2009. There were no differences between genders in lesion characteristics. Women were more likely to have interventions for critical limb ischemia (CLI). In CLI patients with superficial femoral artery (SFA) and tibial lesions, women had better patency rates (P < .005). Conclusions: Women have better patency rates compared with men following treatment of some CLI lesions. Interestingly, women are treated more frequently for CLI when compared to men. For some lesion types in women, PTA alone was equivalent to PTA + S. Our results suggest that outcomes may be optimized by tailoring interventions to gender.

Determinants of Outcome after Endovascular Therapy for Critical Limb Ischemia with Tissue Loss

OBJECTIVE Congestive heart failure (CHF) is a highly prevalent comorbidity among patients with symptomatic peripheral arterial disease. The effect of CHF on the procedural success of endovascular treatment, however, remains unknown. Theoretically, poor inflow secondary to systolic dysfunction and peripheral vascular alterations may predispose endovascular interventions to failure. METHODS A retrospective review of a prospectively maintained database was performed to identify CHF patients undergoing endovascular peripheral arterial intervention from 2004 to 2009. Demographics, comorbidities, procedural details, and outcomes were analyzed. Patients underwent duplex ultrasound imaging and clinical follow-up at scheduled intervals. Kaplan-Meier and Cox proportional hazards models were used to evaluate risk factors for loss of primary patency, secondary patency, and limb salvage. RESULTS Of 1220 patients undergoing intervention, 271 (22%) with documented congestive heart failure (CHF) underwent an intervention for claudication (22.5%) or critical limb ischemia (77.5%). Primary patency at 1 year was 51.9% ± 2.5% among those with CHF vs 64.6% ± 1.3% in those without CHF (P < .001); this disparity continued throughout follow-up (P < .001). Patients with CHF also had reduced secondary patency throughout follow-up. Multivariate analysis showed CHF was an independent predictor of reduced primary patency (hazard ratio [HR], 1.2; 95% confidence interval [CI] 1.0-1.4; P = .038) and secondary patency (HR, 1.5; 95% CI, 1.2-1.8; P < .001). In the setting of CHF, 1-year patency was 56.6% ± 4.1% if the ejection fraction (EF) was >40% (n = 147) vs 43.2% ± 3.5% if the EF was <40% (n = 124; P < .001). Secondary patency was also significantly reduced in patients with EF <40% throughout follow-up compared with patients without CHF (n = 949) as well as those with CHF and EF >40% (P < .001). CHF with EF <40% was an independent predictor of reduced primary patency (HR, 1.4; 95% CI, 1.2-1.8; P < .01) and secondary patency (HR, 1.8; 95% CI, 1.3-2.3; P < .001). Limb salvage was also worse in patients with EF <40% (P = .038). CONCLUSIONS CHF is associated with reduced patency after peripheral endovascular intervention and is an independent risk factor for patency loss. Specifically, CHF and reduced EF (<40%) is a strong independent risk factor for patency loss.