Francesco A. Aiello

Statin therapy is associated with superior clinical outcomes after endovascular treatment of critical limb ischemia

OBJECTIVE The aim of this study was to determine if statin therapy improves clinical outcomes after endovascular intervention in patients with critical limb ischemia (CLI). METHODS A retrospective review of all patients undergoing endovascular treatment for CLI was performed. Two groups were created according to whether they were receiving statin therapy at the time of intervention. Demographics, lesion morphology, overall mortality, primary and secondary patency, and limb salvage were compared between these groups. Analysis was performed using multivariate regression and Kaplan-Meier analysis. RESULTS Between 2004 and 2009, 646 patients, 319 receiving statin therapy and 327 without, underwent an endovascular intervention for CLI. The statin group had significantly higher rates of diabetes mellitus, coronary artery disease, congestive heart failure, previous myocardial infarction, and coronary artery bypass grafting (P < .05). The two groups had similar lesion length, location, lesion type, TransAtlantic Inter-Society Consensus (TASC) classification, and primary procedure. At 24 months, the statin-treated group had higher rates of primary patency (43% vs 33%; P = .007), secondary patency (66% vs 51%; P = .001), limb salvage (83% vs 62%; P = .001), and overall survival (77% vs 62%; P = .038). Statin therapy was also independently associated with improved limb salvage by multivariate regression analysis (hazard ratio, 2.55; P < .001). CONCLUSIONS Patients who were receiving statin therapy when they underwent interventions to treat CLI had significantly improved overall survival, primary and secondary patency, and limb salvage rates. Our findings suggest that statins should be part of the periprocedural treatment regimen and support further investigation into the beneficial effects of statins in patients undergoing endovascular treatment of CLI.

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.

In patients stratified by preoperative risk, endovascular repair of ruptured abdominal aortic aneurysms has a lower in-hospital mortality and morbidity than open repair

OBJECTIVE Previous studies have reported that endovascular repair (EVAR) of ruptured abdominal aortic aneurysms (RAAAs) has lower postoperative mortality than open repair (OR). However, comparisons involved heterogeneous populations that lacked adjustment for preoperative risk. We hypothesize that for RAAA patients stratified by a validated measure of preoperative mortality risk, EVAR has a lower in-hospital mortality and morbidity than does OR. METHODS In-hospital mortality and morbidity after EVAR and OR of RAAA were compared in patients from the Vascular Quality Initiative (2003-2013) stratified by the validated Vascular Study Group of New England RAAA risk score into low-risk (score 0-1), medium-risk (score 2-3), and high-risk (score 4-6) groups. RESULTS Among 514 patients who underwent EVAR and 651 patients who underwent OR of RAAA, EVAR had lower in-hospital mortality (25% vs 33%, P = .001). In risk-stratified patients, EVAR trended toward a lower mortality in the low-risk group (n = 626; EVAR, 10% vs OR, 15%; P = .07), had a significantly lower mortality in the medium-risk group (n = 457; EVAR, 37% vs OR, 48%; P = .02), and no advantage in the high-risk group (n = 82; EVAR, 95% vs OR, 79%; P = .17). Across all risk groups, cardiac complications (EVAR, 29% vs OR, 38%; P = .001), respiratory complications (EVAR, 28% vs OR, 46%; P < .0001), renal insufficiency (EVAR, 24% vs OR, 38%; P < .0001), lower extremity ischemia (EVAR, 2.7% vs OR, 8.1%; P < .0001), and bowel ischemia (EVAR, 3.9% vs OR, 10%; P < .0001) were significantly lower after EVAR than after OR. Across all risk groups, median (interquartile range) intensive care unit length of stay (EVAR, 2 [1-5] days vs OR, 6 [3-13] days; P < .0001) and hospital length of stay (EVAR, 6 [4-12] days vs OR, 13 [8-22] days; P < .0001) were lower after EVAR. CONCLUSIONS This novel risk-stratified comparison using a national clinical database showed that EVAR of RAAA has a lower mortality and morbidity compared with OR in low-risk and medium-risk patients and that EVAR should be used to treat these patients when anatomically feasible. For RAAA patients at the highest preoperative risk, there is no benefit to using EVAR compared with OR.

Follow-up compliance after endovascular abdominal aortic aneurysm repair in Medicare beneficiaries

OBJECTIVE Lifelong imaging follow-up is essential to the safe and appropriate management of patients who undergo endovascular abdominal aortic aneurysm repair (EVAR). We sought to evaluate the rate of compliance with imaging follow-up after EVAR and to identify factors associated with being lost to imaging follow-up. METHODS We identified a 20% sample of continuously enrolled Medicare beneficiaries who underwent EVAR between 2001 and 2008. Using data through 2010 from Medicare Inpatient, Outpatient, and Carrier files, we identified all abdominal imaging studies that may have been performed for EVAR follow-up. Patients were considered lost to annual imaging follow-up if they did not undergo any abdominal imaging study within their last 2 years of follow-up. Multivariable models were constructed to identify independent factors associated with being lost to annual imaging follow-up. RESULTS Among 19,962 patients who underwent EVAR, the incidence of loss to annual imaging follow-up at 5 years after EVAR was 50%. Primary factors associated with being lost to annual imaging follow-up were advanced age (age 65-69 years, reference; age 75-79 years: hazard ratio [HR], 1.23; 95% confidence interval [CI], 1.15-1.32; age 80-85 years: HR, 1.45; 95% CI, 1.35-1.55; age >85 years: HR, 2.03; 95% CI, 1.88-2.20) and presentation with an urgent/emergent intact aneurysm (HR, 1.27; 95% CI, 1.20-1.35) or ruptured aneurysm (HR, 1.84; 95% CI, 1.63-2.08). Additional independent factors included several previously diagnosed chronic diseases and South and West regions of the United States. CONCLUSIONS Annual imaging follow-up compliance after EVAR in the United States is significantly below recommended levels. Quality improvement efforts to encourage improved compliance with imaging follow-up, especially in older patients with multiple comorbidities and in those who underwent EVAR urgently or for rupture, are necessary.

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

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.

Outcomes of Fenestrated and Branched Endovascular Repair of Complex Abdominal and Thoracoabdominal Aortic Aneurysms

Background: More than 80% of infrarenal aortic aneurysms are treated by endovascular repair. However, adoption of fenestrated and branched endovascular repair for complex aortic aneurysms has been limited, despite high morbidity and mortality associated with open repair. There are few published reports of consecutive outcomes, inclusive of all fenestrated and branched endovascular repairs, starting from the inception of a complex aortic aneurysm program. Therefore, we examined a single centers consecutive experience of fenestrated and branched endovascular repair of complex aortic aneurysms. Methods: This is a single‐center, prospective, observational cohort study evaluating 30‐day and 1‐year outcomes in all consecutive patients who underwent fenestrated and branched endovascular repair of complex aortic aneurysms (definition: requiring one or more fenestrations or branches). Data were collected prospectively through an Institutional Review Board‐approved registry and a physician‐sponsored investigational device exemption clinical trial (G130210). Results: We performed 100 consecutive complex endovascular aortic aneurysm repairs (November 2010 to March 2016) using 58 (58%) commercially manufactured custom‐made devices and 42 (42%) physician‐modified devices to treat 4 (4%) common iliac, 42 (42%) juxtarenal, 18 (18%) pararenal, and 36 (36%) thoracoabdominal aneurysms (type I, n = 1; type II, n = 4; type III, n = 12; type IV, n = 18; arch, n = 1). The repairs included 309 fenestrations, branches, and scallops (average of 3.1 branch arteries/case). All patients had 30‐day follow‐up for 30‐day event rates: three (3%) deaths; six (6%) target artery occlusions; five (5%) progressions to dialysis; eight (8%) access complications; one (1%) paraparesis; one (1%) bowel ischemia; and no instances of myocardial infarction, paralysis, or stroke. Of 10 type I or type III endoleaks, 8 resolved (7 with secondary intervention, 1 without intervention). Mean follow‐up time was 563 days (interquartile range, 156‐862), with three (3%) patients lost to follow‐up. On 1‐year Kaplan‐Meier analysis, survival was 87%, freedom from type I or type III endoleak was 97%, target vessel patency was 92%, and freedom from aortic rupture was 100%. Average lengths of intensive care unit stay and inpatient stay were 1.4 days (standard deviation, 3.3) and 3.6 days (standard deviation, 3.6), respectively. Conclusions: These results show that complex aortic aneurysms can now be treated with minimally invasive fenestrated and branched endovascular repair. Endovascular technologies will likely continue to play an increasingly important role in the management of patients with complex aortic aneurysm disease.

Endovascular repair of ruptured abdominal aortic aneurysms does not reduce later mortality compared with open repair

OBJECTIVE Endovascular aneurysm repair (EVAR) of ruptured abdominal aortic aneurysms (RAAAs) reduces in-hospital mortality compared with open repair (OR), but it is unknown whether EVAR reduces long-term mortality. We hypothesized that EVAR of RAAA would independently reduce long-term mortality compared with OR. METHODS The Vascular Quality Initiative database (2003-2013) was used to determine Kaplan-Meier 1-year and 5-year mortality after EVAR and OR of RAAA. Multivariate analysis was performed to identify patient and operative characteristics associated with mortality at 1 year and 5 years after RAAA repair. RESULTS Among 590 patients who underwent EVAR and 692 patients who underwent OR of RAAA, the lower mortality seen in the hospital after EVAR (EVAR 23% vs OR 35%; P < .001) persisted at 1 year (EVAR 34% vs OR 42%; P = .001) and 5 years (EVAR 50% vs OR 58%; P = .003) after repair. After adjusting for patient and operative characteristics, EVAR did not independently reduce mortality at 1 year (hazard ratio [HR], 0.88; 95% confidence interval [CI], 0.7-1.1) or 5 years (HR, 0.95; 95% CI, 0.77-1.2) compared with OR. Dialysis dependence (HR, 3.9; 95% CI, 1.8-8.6), home oxygen use (HR, 1.9; 95% CI, 1.3-2.7), cardiac ejection fraction <50% (HR, 1.5; 95% CI, 1.03-2.1), female gender (HR, 1.3; 95% CI, 1.04-1.6), and age (HR, 1.06; 95% CI, 1.05-1.08 per 5 years) as well as cardiac arrest (HR, 3.4; 95% CI, 2.5-4.5), loss of consciousness (HR, 1.7; 95% CI, 1.3-2.2), and preoperative systolic blood pressure <90 mm Hg (HR, 1.4; 95% CI, 1.1-1.8) on admission predicted mortality at 1 year and 5 years after RAAA repair. Type I endoleak (HR, 2.2; 95% CI, 1.2-3.8) also predicted mortality at 1 year. CONCLUSIONS EVAR does not independently reduce long-term mortality compared with OR. Patient comorbidities and indices of shock on admission are the primary independent determinants of long-term mortality. However, the lower early mortality observed in the Vascular Quality Initiative for patients selected to undergo EVAR of RAAA compared with patients selected for OR is sustained over time, suggesting that EVAR for RAAA is beneficial in appropriate candidates. Better elucidation of the key selection factors, including aneurysm anatomy, is needed to best select patients for EVAR and OR to reduce long-term mortality.

Post-appendectomy visits to the emergency department within the global period: a target for cost containment.

BACKGROUND Postoperative visits to the emergency department (ED) instead of the surgeons office consume enormous cost. HYPOTHESIS Postoperative ED visits can be avoided. SETTING Fully accredited, single-institution, 617-bed hospital affiliated with the University of Connecticut School of Medicine. PATIENTS Retrospective analysis of 597 consecutive patients with appendectomies over a 4-year period. METHODS Demographic and medical data, at initial presentation, surgery, and ED visit were recorded as categorical variables and statistically analyzed (Pearson chi(2) test, Fisher exact test, and linear-by-linear). Costs were calculated from the hospitals billing department. RESULTS Forty-six patients returned to the ED within the global period with pain (n = 22, 48%), wound-related issues (n = 6, 13%), weakness (n = 4, 9%), fever (13%), and nausea and vomiting (n = 3, 6%). Thirteen patients (28%) required readmission. Predictive factors for ED visit postoperatively were perforated appendicitis (2-fold increase over uncomplicated appendicitis) and comorbidities (cardiovascular or diabetes). The cost of investigations during ED visits was

Trends in use of the only Food and Drug Administration-approved commercially available fenestrated endovascular aneurysm repair device in the United States

55,000 plus physician services. CONCLUSIONS ED visits during the postoperative global period are avoidable by identifying patients who may need additional care; improving patient education, optimizing pain control, and improving patient office access.

Endovascular management of radiation-induced subclavian and axillary artery aneurysms

Background: Fenestrated endografts are customized, patient‐specific, endovascular devices with potential to significantly reduce morbidity and mortality of short‐neck infrarenal and juxtarenal abdominal aortic aneurysm repair. The Zenith fenestrated endovascular graft (ZFEN) for abdominal aortic aneurysms (Cook Medical, Bloomington, Ind), Food and Drug Administration‐approved in 2012, remains the only fenestrated device available in the United States. This technology is among the most technically complex catheter‐based procedures and, therefore, inherently associated with serious risk for device‐related complications. We sought to define patterns of physician and hospital adoption of ZFEN. Methods: Deidentified datasets containing numbers of physicians trained, orders by physicians and hospitals, and designs (fenestration/scallop configuration) was provided for U.S. ZFEN devices ordered (April 2012‐August 2015). We evaluated the number of physicians trained, the number of devices ordered, hospital characteristics, and fenestration/scallop design configurations. Cook Medical assembled the datasets but played no role in study design, analysis, or interpretation of data. Results: Between April 2012 and August 2015, 553 physicians attended formal ZFEN training sessions, 388 (70%) of whom ordered a total of 2669 devices. An increase in orders per month (nine in June 2012 and 91 in August 2015, 911% growth; P < .001) and in number of physicians ordering per month (eight in June 2012 and 62 in August 2015, 675% growth; P < .001) was observed. Teaching hospitals, representing all U.S. regions (Midwest 927, 35%; South 799, 30%; Northeast 547, 20%; West 396, 15%), accounted for 1703 (64%) ZFEN orders. Of 553 trained physicians, 165 (30%) ordered no devices, 116 (21%) ordered 1 device, 144 (26%) ordered 2‐5 devices, 61 (11%) ordered 6‐10 devices, 39 (7%) ordered 11‐20, and 28 (5%) ordered >20 devices. For physicians contributing >6 months of data (n = 336), the average number of devices ordered per year was three (standard deviation, 4); 272 (81%) ordered ≤ 5 devices/year, 15 (4.5%) ordered 11‐20 devices/year, and 3 (0.9%) ordered >20 devices/year. Of devices with design details available (2618 of 2669; 98%), most common designs were 2 small fenestrations/1 scallop (1443; 55%), 2 small fenestrations/1 large fenestration (568; 22%), 1 small fenestration/1 scallop (173, 6.6%), and 2 small fenestrations (169; 6.5%). The average number of target vessels incorporated in each design was 2.7/device; 2071 (79%) incorporated three, 398 (15%) incorporated two. Conclusions: Since 2012, ZFEN has demonstrated a ninefold increase in monthly orders, with 553 physicians trained. Unlike the experience of rapid dissemination seen with infrarenal endografts, only 28 (5%) physicians have ordered >20, whereas 165 (30%) have ordered none, and 272 (81%) ordered ≤ 5 devices/year. Assuming that volume, in general, correlates with outcomes, this adoption pattern raises questions whether fenestrated technology should be regionalized to high‐volume centers.