Female and male patients have similar outcomes after transcarotid artery revascularization in prospective trials.

OBJECTIVE: Sex disparities in outcomes after carotid revascularization have long been a concern, with several studies demonstrating increased postoperative death and stroke for female patients after either carotid endarterectomy or transfemoral stenting. Adverse events after transfemoral stenting are higher in female patients, particularly in symptomatic cases. Our objective was to investigate outcomes after transcarotid artery revascularization (TCAR) stratified by patient sex hypothesizing that the results would be similar between males and females. METHODS: We analyzed prospectively collected data from the Safety and Efficacy Study for Reverse Flow Used During Carotid Artery Stenting Procedure (ROADSTER)1 (pivotal), ROADSTER2 (US Food and Drug Administration indicated postmarket), and ROADSTER Extended Access TCAR trials. All patients had verified carotid stenosis meeting criteria for intervention (≥80% for asymptomatic patients and ≥50% in patient with symptomatic disease), and were included based on anatomical or clinical high-risk criteria for carotid stenting. Neurological assessments (National Institutes of Health Stroke Scale, Modified Rankin Scale) were obtained before and within 24 hours from procedure end by an independent neurologist or National Institutes of Health Stroke Scale-certified nurse. Patients were stratified by sex (male vs female). Baseline demographics were compared using χ2 and Fisher's exact tests where appropriate; primary outcomes were combination stroke/death (S/D) and S/D/myocardial infarction (S/D/M) at 30 days, and secondary outcomes were the individual components of S/D/M. Univariate logistic regression was conducted. RESULTS: We included 910 patients for analysis (306 female [33.6%], 604 male [66.4%]). Female patients were more often <65 years old (20.6% vs 15%) or ≥80 years old (22.6% vs 20.2%) compared with males, and were more often of Black/African American ethnicity (7.5% vs 4.3%). There were no differences by sex in term of comorbidities, current or prior smoking status, prior stroke, symptomatic status, or prevalence of anatomical and/or clinical high-risk criteria. General anesthetic use, stent brands used, and procedure times did not differ by sex, although flow reversal times were longer in female patients (10.9 minutes male vs 12.4 minutes female; P = .01), as was more contrast used in procedures for female patients (43 mL male vs 48.9 mL female; P = .049). The 30-day S/D and S/D/M rates were similar between male and female patients (S/D, 2.7% male vs 1.6% female [P = .34]; S/D/M, 3.6% male vs 2.6% female [P = .41]), which did not differ when stratified by symptom status. Secondary outcomes did not differ by sex, including stroke rates at 30 days (2.2% male vs 1.6% female; P = .80), nor were differences seen with stratification by symptom status. Univariate analysis demonstrated that history of a prior ipsilateral stroke was associated with increased odds of S/D (odds ratio [OR], 4.19; P = .001) and S/D/M (OR, 2.78; P = .01), as was symptomatic presentation with increased odds for S/D (OR, 2.78; P = .02). CONCLUSIONS: Prospective TCAR trial data demonstrate exceptionally low rates of S/D/MI, which do not differ by patient sex.

Intermittent claudication treatment patterns in the commercially insured non-Medicare population.

OBJECTIVE: Despite published guidelines and data for Medicare patients, it is uncertain how younger patients with intermittent claudication (IC) are treated. Additionally, the degree to which treatment patterns have changed over time with the expansion of endovascular interventions and outpatient centers is unclear. Our goal was to characterize IC treatment patterns in the commercially insured non-Medicare population. METHODS: The IBM MarketScan Commercial Database, which includes more than 8 billion US commercial insurance claims, was queried for patients newly diagnosed with IC from 2007 to 2016. Patient demographics, medication profiles, and open/endovascular interventions were evaluated. Time trends were modeled using simple linear regression and goodness-of-fit was assessed with coefficients of determination (R2). A patient-centered cohort sample and a procedure-focused dataset were analyzed. RESULTS: Among 152,935,013 unique patients in the database, there were 300,590 patients newly diagnosed with IC. The mean insurance coverage was 4.4 years. The median patients age was 58 years and 56% of patients were male. The prevalence of statin use was 48% among patients at the time of IC diagnosis and increased to 52% among patients after one year from diagnosis. Interventions were performed in 14.3%, of whom 20% and 6% underwent two or more and three or more interventions, respectively. The median time from diagnosis to intervention decreased from 230 days in 2008 days to 49 days in 2016 (R2 = 0.98). There were 16,406 inpatient and 102,925 ambulatory interventions for IC over the study period. Among ambulatory interventions, 7.9% were performed in office-based/surgical centers. The proportion of atherectomies performed in the ambulatory setting increased from 9.7% in 2007 to 29% in 2016 (R2 = 0.94). In office-based/surgical centers, 57.6% of interventions for IC used atherectomy in 2016. Atherectomy was used in ambulatory interventions by cardiologists in 22.6%, surgeons in 15.2%, and radiologists in 13.6% of interventions. Inpatient atherectomy rates remained stable over the study period. Open and endovascular tibial interventions were performed in 7.9% and 7.8% of ambulatory and inpatient IC interventions, respectively. Tibial bypasses were performed in 8.2% of all open IC interventions. CONCLUSIONS: There has been shorter time to intervention in the treatment of younger, commercially insured patients with IC, with many receiving multiple interventions. Statin use was low. Ambulatory procedures, especially in office-based/surgical centers, increasingly used atherectomy, which was not observed in inpatient settings.

Outcomes for carotid endarterectomy in nonagenarians.

OBJECTIVE: Carotid endarterectomy (CEA) is a well-established procedure with prospective randomized data demonstrating the benefit of stroke prevention. With the aging of the population, there are limited data published for nonagenarians, especially for asymptomatic stenosis. This study investigated 30-day morbidity and mortality as well as late survival in symptomatic and asymptomatic nonagenarians with severe carotid stenosis undergoing CEA. METHODS: A retrospective review was conducted of a single vascular surgery group's registry involving multiple hospitals between November 1994 and June 2017 for all primary CEAs of patients ≥90 years old at the time of surgery. The exclusion criterion was redo surgery or bilateral CEAs. Demographic data, sex, symptoms, risk factors, and postoperative complications were analyzed. Survival analysis was conducted using SPSS software (IBM Corp, Armonk, NY) for the specific end point 30-day morbidity or mortality and late survival. RESULTS: There were 77 patients (44 male [57%]) who underwent CEA for symptomatic (44 [57%]) and asymptomatic (33 [43%]) internal carotid artery stenosis with a median age of 92 years; 23 women were symptomatic compared with 21 men, and 23 men were asymptomatic compared with 10 women. Symptomatic patients included amaurosis fugax (n = 3), stroke (n = 16), and transient ischemic attack (n = 25). CEAs were performed using the eversion technique under cervical block with selective shunting. The 30-day morbidity included one (2.3%) nonfatal myocardial infarction and one (2.3%) ischemic stroke in the symptomatic group compared with one (3%) patient having a nonfatal myocardial infarction and none with ischemic stroke in the asymptomatic group. One patient of the symptomatic group required return to the operating room for hematoma evacuation. The 30-day mortality was 2.3% in the symptomatic group compared with 6.1% in the asymptomatic group. There was no statistical difference in survival based on sex (P = .444). The symptomatic and asymptomatic groups had similar median survival of 27.7 months and 29.4 months (P = .987), respectively. CONCLUSIONS: The aging population adds increasing difficulty in decision-making for surgical intervention on carotid stenosis. CEA in nonagenarians is associated with reasonably low 30-day rates of ischemic stroke and myocardial infarction in our small study. However, enthusiasm for asymptomatic CEA in this population must be tempered by low survival rates.

Regionalization of Emergent Vascular Surgery for Patients With Ruptured AAA Improves Outcomes.

OBJECTIVE: Safe and efficient endovascular aneurysm repair (EVAR) for ruptured abdominal aortic aneurysm (r-AAA) requires advanced infrastructure and surgical expertise not available at all US hospitals. The objective was to assess the impact of regionalizing r-AAA care to centers equipped for both open surgical repair (r-OSR) and EVAR (r-EVAR) by vascular surgeons. METHODS: A retrospective review of all patients with r-AAA undergoing open or endovascular repair in a 12-hospital region. Patient demographics, transfer status, type of repair, and intraoperative variables were recorded. Outcomes included perioperative morbidity and mortality. RESULTS: Four hundred fifty-one patients with r-AAA were treated from 2002 to 2015. Three hundred twenty-one patients (71%) presented initially to community hospitals (CHs) and 130 (29%) presented to the tertiary medical center (MC). Of the 321 patients presenting to CH, 133 (41%) were treated locally (131 OSR; 2 EVAR) and 188 (59%) were transferred to the MC. In total, 318 patients were treated at the MC (122 OSR; 196 EVAR). At the MC, r-EVAR was associated with a lower mortality rate than r-OSR (20% vs 37%, P = 0.001). Transfer did not influence r-EVAR mortality (20% in r-EVAR presenting to MC vs 20% in r-EVAR transferred, P > 0.2). Overall, r-AAA mortality at the MC was 20% lower than CH (27% vs 46%, P < 0.001). CONCLUSIONS: Regionalization of r-AAA repair to centers equipped for both r-EVAR and r-OSR decreased mortality by approximately 20%. Transfer did not impact the mortality of r-EVAR at the tertiary center. Care of r-AAA in the US should be centralized to centers equipped with available technology and vascular surgeons.

Anatomic characteristics of abdominal aortic aneurysms presenting with delayed rupture after endovascular aneurysm repair.

OBJECTIVE: Endovascular aneurysm repair (EVAR) has become the mainstay of treatment for abdominal aortic aneurysms (AAAs) requiring repair. Delayed rupture after EVAR represents a rare but potentially fatal complication. The purpose of this study was to review the frequency and characteristics of patients presenting with secondary rupture and to define the relationship between rupture after EVAR and initial compliance with instructions for use (IFU). METHODS: This is a retrospective study of a prospectively maintained database. Patients presenting with delayed rupture after EVAR were identified from January 2002 to December 2014. Medical records and imaging were reviewed to define anatomic characteristics and compliance with IFU criteria. Demographics, comorbidities, preoperative imaging, and long-term outcomes were analyzed. Patients were divided into two groups according to compliance with IFU criteria. Outcomes included type of repair (open vs secondary endovascular) as well as perioperative morbidity and mortality. RESULTS: A total of 3081 patients underwent EVAR for AAA from 2002 to 2014. Of the 3081 patients, 45 experienced delayed rupture after EVAR. The mean time interval between initial repair and rupture was 38 months. All patients with delayed ruptures had a type Ia endoleak. Mean follow-up after secondary repair was 44.1 months, and overall mortality was 6.7% (n = 3). Patients were divided in two groups according to compliance with IFU criteria: within the IFU and outside the IFU. There was no significant difference in comorbidities between the two groups except smoking, which was more frequent in the outside the IFU group (25% vs 21%; P = .03). Patients repaired outside the IFU had a higher incidence of type Ia endoleak before presenting with a rupture (44% vs 6%; P = .001), more frequently required open repair (44% vs 12%; P = .002), and had higher perioperative mortality (10.3% vs 0%; P = .01). On review of preoperative computed tomography scans, the outside the IFU group had larger aneurysm sac diameters (7.2 vs 5.6 cm; P = .04), larger proximal neck diameters (28 vs 24 mm; P = .01), shorter proximal necks (12 vs 21 mm; P = .007), and a higher degree of neck angulation >40 degrees (56 vs 11%; P < .001). CONCLUSIONS: Delayed rupture after EVAR is a rare but potentially fatal complication. In patients presenting with secondary rupture, EVAR performed outside the IFU was associated with higher perioperative mortality and need for open repair. Careful selection of patients based on AAA anatomy and adherence to the IFU criteria may reduce the incidence of delayed rupture.

Chronic mesenteric ischemia outcome analysis and predictors of endovascular failure.

OBJECTIVE: Outcomes of open revascularization (OR) and endovascular revascularization (ER) for chronic mesenteric ischemia (CMI) were analyzed to identify predictors of endovascular failure. METHODS: A retrospective study was performed of all consecutive patients with CMI (161 patients, 215 vessels) treated from 2008 to 2012. Demographics, comorbidities, clinical presentation, etiology, and treatment modalities were compared. Outcomes included technical success, restenosis requiring reintervention, complications, mortality, and hospital length of stay. RESULTS: There were 116 patients who were first treated with ER (72%) and 45 patients with OR (28%). Overall mortality was 6.8% (11/161). Among the ER patients, 27 developed restenosis and required OR (23%). Patients treated with ER were older (73 vs 66 years; P = .014), had similar comorbidities, and had higher rate of short lesions (≤2 cm) on preoperative angiograms (23% vs 47%; P = .004). Primary patency at 3 years was higher in the OR group compared with the ER group (91% vs 74%; P = .018). Long-term survival rates were higher in the ER group (95% vs 78%; P = .003). Hospital length of stay and intensive care unit length of stay were shorter in the ER group (<.001). Perioperative mortality (30-day) was not statistically significant between the groups (5.2% vs 11%; P = .165). A subgroup analysis was performed between the patients with successful ER and failure of ER requiring OR. Patients with failure of ER had significantly higher rates of aortic occlusive disease (86% vs 49%; P = .005) and long lesions ≥2 cm on angiography (57% vs 12%; P < .001) that were close to the mesenteric takeoff. Perioperative mortality was higher in the ER failure group (15% vs 2%; P = .009). CONCLUSIONS: ER has similar perioperative mortality and shorter hospitalization but higher rate of restenosis requiring reintervention compared with OR. Patients with ER who required reintervention appear to have longer lesions as well as higher rates of aortic occlusive disease on preoperative angiography. Patients who crossed over from ER to OR had higher perioperative mortality than either primary open or endovascular patients. These findings may guide treatment selection in patients with CMI undergoing ER or OR.

Standardized protocols enable stroke recognition and early treatment of carotid stenosis.

OBJECTIVE: This study examined the effect of acute ischemic stroke (AIS) care coordination between vascular surgery and stroke neurology services with primary focus on acute patient stabilization and expeditious carotid endarterectomy (CEA). METHODS: A standardized AIS protocol was instituted between vascular surgery and stroke neurology services in an academic hospital (group I) that included: (1) rapid patient evaluation and imaging inclusive of brain and carotid computed tomography/magnetic resonance angiography, carotid duplex ultrasound imaging or conventional arteriogram, or both; (2) patient admission to a dedicated stroke unit with minimum 1:2 intensive care nurse-to-patient staffing and a 24-hour available neurointensivist; (3) treatment of all patients with ipsilateral moderate or severe carotid stenosis by CEA with cervical block (158 [81%]) or general anesthesia (38 [19%]). Patient exclusion from undergoing expeditious CEA included (1) stroke in evolution, and (2) dense neurologic deficit or National Institutes of Health Stroke Scale score >15 (severe), or both. Comparisons of data were performed between group I patients and those treated in outlying hospitals (group II) for similar indications. All data were prospectively collected in a computerized database and outcomes evaluated retrospectively. RESULTS: From November 2002 to November 2012, 369 patients underwent CEA for AIS ≤1 week of presentation. There were 192 patients in group I and 177 in group II. There were no differences in group I and II in mean stroke-to-CEA interval (3.4 vs 3.9 days) or in the performance of eversion CEA (94% vs 97%), respectively. Intraoperative shunt use was greater in group I (28%) than in group II (18%; P = .021). Fewer total neurologic events (stroke or transient ischemic attack) occurred in group I (6 [3.1%] vs 14 [7.3%]; P = .03). No patients died in either group. Postoperative National Institutes of Health Stroke Scale scores available in group I patients showed improvement from preoperative baseline in mild and moderate stroke patients (P < .001). CONCLUSIONS: In patients with stable acute stroke, early CEA is feasible and relatively safe. Stroke or death occurs in only 1%, and most complications are of nonfatal cardiac origin. A standardized stroke team protocol that is inclusive of stroke neurologists and vascular surgeons allows for expeditious and safe CEA in the setting of an acute stroke.

The impact of hemodynamic status on outcomes of endovascular abdominal aortic aneurysm repair for rupture.

OBJECTIVE: To date, there are no published reports comparing hemodynamically (Hd)-stable and Hd-unstable patients with ruptured abdominal aortic aneurysms (r-AAAs) undergoing endovascular aneurysm repair (EVAR). This study evaluates outcomes of EVAR for r-AAA based on patient's Hd status METHODS: From 2002 to 2011, 136 patients with r-AAAs underwent EVAR and were categorized into two groups based on systolic blood pressure (SBP) measurements before EVAR: 92 (68%) Hd-stable (SBP ≥ 80 mm Hg) and 44 (32%) Hd-unstable (SBP <80 mm Hg for >10 minutes). All data were prospectively entered in a database and retrospectively analyzed. Outcomes included 30-day mortality, postoperative complications, the need for secondary reinterventions, and midterm mortality. The effect of potential predictors on 30-day mortality was assessed by χ(2) and logistic regression. RESULTS: Of the 136 r-AAA patients with EVAR, the Hd-stable and Hd-unstable groups had similar comorbidities (coronary artery disease, 63% vs 59%; hypertension, 72% vs 75%; chronic obstructive pulmonary disease, 21% vs 26%; and chronic renal insufficiency, 18% vs 18%), mean AAA maximum diameter (6.6 vs 6.4 cm), need for on-the-table conversion to open surgical repair (3% vs 7%), and incidences of nonfatal complications (43% vs 38%) and secondary interventions (23% vs 25%). Preoperative computed tomography scan was available in significantly fewer Hd-unstable patients (64% vs 100%; P < .05). Compared with Hd-stable patients, the Hd-unstable patients had a significantly higher intraoperative need for aortic occlusion balloon (40% vs 6%; P < .05), mean estimated blood loss (744 vs 363 mL; P < .05), incidence of developing abdominal compartment syndrome (ACS; 29% vs 4%; P < .01), and death (33% vs 18%; P < .05). ACS was a significant predictor of death; death in all r-EVAR with ACS was significantly higher compared with all r-EVAR without ACS (10 of 17 [59%] vs 22 of 119 [18%]; P < .01). CONCLUSIONS: EVAR for r-AAA is feasible in Hd-stable and Hd-unstable patients, with a comparable incidence of conversion to open surgical repair, nonfatal complications, and secondary interventions. Hd-stable patients have reduced mortality at 30 days, whereas Hd-unstable patients require intraoperative aortic occlusion balloon more frequently, and have an increased risk for developing ACS and death.

Endovascular repair of ruptured infrarenal abdominal aortic aneurysm is associated with lower 30-day mortality and better 5-year survival rates than open surgical repair.

OBJECTIVE: Endovascular aneurysm repair (EVAR) decreases 30-day mortality for patients with ruptured abdominal aortic aneurysms (r-AAAs) compared with open surgical repair (OSR). However, which patients benefit or whether there is any long-term survival advantage is uncertain. METHODS: From 2002 to 2011, 283 patients with r-AAA underwent EVAR (n = 120 [42.4%]) or OSR (n = 163 [57.6%]) at Albany Medical Center. All data were collected prospectively. Patients were analyzed on an intention-to-treat basis, and outcomes were evaluated by a logistic regression multivariable model. Kaplan-Meier analysis was used to compare long-term survival. RESULTS: The EVAR patients had a significantly lower 30-day mortality than did the OSR patients (29/120 [24.2%] vs 72/163 [44.2%]; P < .005) and better cumulative 5-year survival (37% vs 26%; P < .005). Men benefited more from EVAR (mortality: 20.9% for EVAR vs 44.3% for OSR; P < .001) than did women (mortality: 32.4% vs 43.9%; P = .39). Age ≥80 years was a significant predictor of death for EVAR (odds ratio [OR], 1.07; P = .003) but not for OSR (OR, 1.04; P = .056). Preexisting hypertension was a significant predictor of survival for both EVAR (OR, 0.17; P < .001) and OSR (OR, 0.48; P = .021). Almost one fourth of EVAR patients (21/91 [23.1%]) required secondary interventions. Survival advantage was maintained for EVAR patients to 5 years. CONCLUSIONS: For r-AAA, EVAR reduces the 30-day mortality and improves long-term survival up to 5 years. However, whereas open survivors require few graft-related interventions, up to 23% of EVAR patients will require reintervention for endoleaks or graft migration. Close follow-up of all EVAR survivors is mandatory.

Does Palmaz XL stent deployment for type 1 endoleak during elective or emergency endovascular aneurysm repair predict poor outcome? A multivariate analysis of 1470 patients.

BACKGROUND: Endovascular aneurysm repair (EVAR) is now the standard of care for elective infrarenal and ruptured abdominal aortic aneurysms (AAAs). Difficult proximal necks often require adjuvant measures to seal type 1 endoleaks. We believed this was a predictor of increased 30-day morbidity and mortality and reduced long-term survival. METHODS: We reviewed outcomes for all patients entered into our database between 2003 and 2010 who had EVAR for elective or ruptured AAAs. Patient demographics and operative indications were recorded. Operative procedures, including adjuvant procedures, such as Palmaz XL stent deployment, were documented. All postoperative deaths and morbidity were recorded. Long-term survival was calculated using life table analysis. Multivariate analysis was performed to determine significant predictors of early mortality. RESULTS: Between 2003 and 2010, 1470 patients underwent EVAR for AAA (1378 [93.7%] elective; 92 [6.3%] ruptured or emergent). Elective EVAR patients required Palmaz stent placement in 146 of 1378 (10.6%) cases; in emergent cases, Palmaz stents were required in 16 of 92 (17.4%) cases. This was not significantly different (P=0.06). Thirty-day mortality for elective EVAR was 1.6% (22/1378) compared with 21.7% (20/92) for emergent repair (P<0.0001). Thirty-day mortality among the 146 elective patients undergoing Palmaz stenting was 3.4% compared with 1.4% in the 1232 non-Palmaz stent elective EVAR patients (P=0.085). In emergency cases, the 30-day mortality for the 16 Palmaz patients was 25% compared to 21% for the 76 non-Palmaz stent patients (P=0.76). Among 30-day survivors, there were 428 of 1356 (31.6%) endoleaks identified in the elective patient group and 36 of 72 (50%) in the emergency group (P<0.005). Of the 146 elective patients requiring insertion of a Palmaz stent, 65 (44%) developed endoleaks, significantly more than the 370 of 1232 (30%) in non-Palmaz elective patients (P=0.0004). Among the emergency group, there were also significantly more endoleaks among the 30-day survivors who had a Palmaz stent deployed. In elective EVAR requiring Palmaz XL stents, 14% still had type 1 endoleaks at the end of their procedure; 13% still had type 1 endoleaks in the rupture EVAR Palmaz group. Multivariate analysis of all patients found that while female sex, AAA diameter, and estimated blood loss predicted 30-day mortality, deployment of a Palmaz stent did not. Long-term survival among Palmaz patients was not significantly different from non-Palmaz patients in the elective or emergent setting, although Palmaz patients required more secondary interventions. CONCLUSIONS: During EVAR, deployment of a Palmaz stent is more frequently required in patients with rupture, female sex, and larger sac size. However, Palmaz stent deployment itself is not an independent predictor of increased 30-day mortality in either the elective or emergency setting or of poorer long-term survival. However, they are associated with a greater number of postoperative endoleaks, especially type 1 endoleaks, and predict a greater need for secondary interventions.

Women derive less benefit from elective endovascular aneurysm repair than men.

BACKGROUND: Women have a lower chance of surviving elective open abdominal aortic repair. The reasons for this are not clear. Endovascular repair has clearly reduced early and midterm morbidity and mortality for patients with large abdominal aortic aneurysms (AAAs). However, most patients are male. It is unclear whether there has been any reduction in elective morbidity for females or what the extent of that reduction has been. We prospectively analyzed outcomes for elective endovascular aneurysm repair (EVAR) in women at our center and compared results with those for elective open surgery and emergent open and endovascular repair. METHODS: All patients undergoing elective and emergency AAA from 2002 to 2009 were prospectively entered into a database. Demographic details, including gender, were tabulated. Outcome measures were operative blood loss, incidence of type 1 endoleaks, length of in-hospital stay, postoperative complications, 30-day all-cause mortality, and secondary interventions during the follow-up period. Statistical analysis was performed using Fischer exact test and Student t test. A multivariate analysis was also performed. RESULTS: From 2002 to 2009, there were 2631 abdominal aortic aneurysms (AAA) open and endovascular repairs performed in our center (1698 endovascular aneurysm repairs [EVARs], 933 "open"). Males comprised 1995 (76%) of patients; females 636 (24%). There were 1592 elective EVARs (1248 male, 344 female) and 106 emergency EVARs (73 male, 33 female). Elective open repair was performed in 788 patients (579 male, 209 female) and emergency open repair in 149 (73 male, 76 female). For women, elective EVAR resulted in significantly greater mortality rates than men (3.2% vs 0.96%, P < .005). There was a greater incidence of intraoperative aortic neck or iliac artery rupture (4.1% vs 1.2% P = .002) and use of Palmaz stents for type 1 endoleaks (16.1% vs 8%, P = .0009). Mean blood loss was greater in females (327 mL vs 275 mL, P = .038). Perioperative complications were also more frequent in women: leg ischemia (3.5% vs 0.6%, P = .003) and colon ischemia requiring colectomy (0.9% vs 0.2%, P = .009). Mean hospital stay was also longer (3.7 days vs 2.2 days, P = .0001). In contrast, there were no gender differences for any of these outcome measures for elective open repair or emergency open surgery or EVAR. There was no significant difference in death rates between EVAR and open repair in women (3.2% vs 5.7%). In males, the 30-day mortality was 0.96% for elective EVAR and 4.7% for elective open surgery. Following logistic regression, female gender remains a significant risk even when the effects of aneurysm size and age are considered (odds ratio 3.4, P < .01). CONCLUSIONS: Mortality for females undergoing elective EVAR is significantly greater than for males. It is also more hazardous. Colon ischemia, native arterial rupture, and type 1 endoleaks are more frequent. Elective endovascular aneurysm repair benefits men more than women.

The role of amputation as an outcome measure in cellular therapy for critical limb ischemia: implications for clinical trial design.

BACKGROUND: Autologous bone marrow-derived stem cells have been ascribed an important therapeutic role in No-Option Critical limb Ischemia (NO-CLI). One primary endpoint for evaluating NO-CLI therapy is major amputation (AMP), which is usually combined with mortality for AMP-free survival (AFS). Only a trial which is double blinded can eliminate physician and patient bias as to the timing and reason for AMP. We examined factors influencing AMP in a prospective double-blinded pilot RCT (2:1 therapy to control) of 48 patients treated with site of service obtained bone marrow cells (BMAC) as well as a systematic review of the literature. METHODS: Cells were injected intramuscularly in the CLI limbs as either BMAC or placebo (peripheral blood). Six month AMP rates were compared between the two arms. Both patient and treating team were blinded of the assignment in follow-up examinations. A search of the literature identified 9 NO-CLI trials, the control arms of which were used to determine 6 month AMP rates and the influence of tissue loss. RESULTS: Fifteen amputations occurred during the 6 month period, 86.7% of these during the first 4 months. One amputation occurred in a Rutherford 4 patient. The difference in amputation rate between patients with rest pain (5.6%) and those with tissue loss (46.7%), irrespective of treatment group, was significant (p = 0.0029). In patients with tissue loss, treatment with BMAC demonstrated a lower amputation rate than placebo (39.1% vs. 71.4%, p = 0.1337). The Kaplan-Meier time to amputation was longer in the BMAC group than in the placebo group (p = 0.067). Projecting these results to a pivotal trial, a bootstrap simulation model showed significant difference in AFS between BMAC and placebo with a power of 95% for a sample size of 210 patients. Meta-analysis of the literature confirmed a difference in amputation rate between patients with tissue loss and rest pain. CONCLUSIONS: BMAC shows promise in improving AMP-free survival if the trends in this pilot study are validated in a larger pivotal trial. The difference in amp rate between Rutherford 4 & 5 patients suggests that these patients should be stratified in future RCTs.

Treatment options for delayed AAA rupture following endovascular repair.

PURPOSE: Delayed abdominal aortic aneurysm (AAA) rupture is a well recognized complication of endovascular aneurysm repair (EVAR). We wanted to evaluate the frequency, etiology, and outcomes of delayed AAA rupture following EVAR, and identify treatment options that facilitate improved survival. METHODS: From 2002 to 2009, 1768 patients underwent elective and emergent EVAR. At a mean follow-up of 29 months, 27 (1.5%) patients presented with delayed AAA rupture and required repair by either open surgical conversion or endovascular means. All data were prospectively collected in a vascular registry, and outcomes analyzed. RESULTS: Over a mean follow-up of 29 months, the incidence of delayed AAA rupture after elective EVAR was 1.4% (24 of 1615 patients), and after emergent EVAR for ruptured AAA was 2.8% (3 of 106 patients). Of the 27 delayed AAA rupture patients, 20 (74%) were considered "lost to follow-up," and, at presentation, 17 (63%) patients had Type 1 endoleak with stent graft migration, three (11%) had Type 1 endoleak without stent graft migration, five (19%) had Type 2 endoleak, and two (7%) had undetermined etiology for aneurysm rupture. Fifteen (55%) patients underwent open surgical repair via retroperitoneal approach with partial (n = 8; 53%) or complete (n = 7; 47%) stent graft explants and aortoiliac reconstruction, 11 (41%) patients underwent a second EVAR, and one (4%) patient refused treatment and died. Supraceliac aortic clamp was required in three (20%) patients with open surgical conversion, and supraceliac occlusion balloon was required in two (18%) patients with EVAR. There were three (11%) postoperative deaths; two following open surgical conversion and one following EVAR. One additional redo-EVAR patient has undergone successful elective conversion to open surgical repair for persistent type II endoleak and increase in AAA size. CONCLUSIONS: Delayed AAA rupture following EVAR can be successfully managed in most patients by open surgical conversion or secondary EVAR. The approach to each patient should be individualized; complete stent graft explant is not necessary in most patients; a secondary EVAR for delayed AAA rupture with or without an elective conversion to open surgical repair remains a viable option. Vigilant routine follow-up is needed for all patients after EVAR.