Objective Stent graft coverage of the left subclavian artery (LSA) may be required to achieve an adequate landing zone in up to 40% of descending thoracic aneurysms (DTAs). The Valiant Mona LSA ...Thoracic Stent Graft System (Medtronic, Santa Rosa, Calif) consists of a main stent graft and a branch stent graft designed to maintain LSA patency while diverting circulation through the encroaching aneurysm. Participating in the United States Food and Drug Administration's new Innovation Pathway, this first-in-human, early feasibility study evaluates early clinical experience of the Valiant Mona LSA Stent Graft System in patients with DTAs where the proximal landing zone necessitates LSA coverage. Methods This premarket, nonrandomized, single-arm prospective study recruited nine patients (age 72.9 ± 7.6 years). Primary end points were aneurysm-related mortality, stroke, paraplegia, left arm/hand ischemia, and treatment success. Neurologic events were assessed by imaging and by independent neurologists. Inclusion criteria required patients with a DTA or penetrating aortic ulcer to have a distance of ≥10 mm between the left common carotid artery and the LSA. Mean aneurysm diameter was 53.7 ± 10.0 mm. The indication for repair was for saccular DTA in five patients or fusiform DTA in four. Seven patients were at American Society of Anesthesiologists Physical Status Classification III/IV. Results All nine patients received one main stent graft (diameter 28 to 42 mm) and one branch stent graft (diameter 10 to 14 mm). To extend device coverage distally, a commercial Valiant Captivia device was implanted in seven patients. No uncorrected endoleaks were observed at the end of the implant procedure. Four endoleaks developed before discharge in four of eight evaluable patients. Two were identified as type II and two were of undetermined type. No endoleak resulted in a secondary intervention. Technical success, defined by the clinical investigational plan, was achieved in all nine patients intraoperatively, and treatment success was achieved in all eight evaluable patients at 1 month. There were no major, disabling strokes. Four minor nondisabling strokes were reported in three patients ≤30 days (days 1, 1, 5, and 24). To date, there have been no reports of death, left arm ischemia, paraplegia, rupture, conversion to open surgery, or secondary endovascular procedure. No patients required surgical LSA revascularization. Conclusions The Valiant Mona LSA system demonstrates technical and treatment success, relative safety, and early durability in its initial use in DTA patients. Midterm results are expected as patients are monitored at regular intervals to 5 years.
AbstractObjectiveEndovascular repair of abdominal aortic aneurysm (AAA) remains a challenging clinical scenario when there is a short or nonexistent segment of healthy infrarenal aorta. This study ...sought to determine the safety and effectiveness of endosuture aneurysm repair (ESAR) using the Endurant II/IIs endograft (Medtronic Vascular, Santa Rosa, Calif) in conjunction with Heli-FX EndoAnchors (Medtronic Vascular) in the treatment of short-neck AAA. MethodsIn this subgroup analysis, 70 patients were identified from the Aneurysm Treatment Using the Heli-FX EndoAnchor System Global Registry (ANCHOR) who had an infrarenal neck length <10 mm down to 4 mm based on core laboratory measurements. Primary outcomes included technical success of the index procedure, rate of type IA endoleak at 1 month and 12 months, and rate of secondary procedures at 12 months. ResultsIn this short-neck cohort (n = 70), the average neck length and diameter were 6.9 ± 1.6 mm and 25.7 ± 4.0 mm, respectively. Investigators reported an overall procedural success rate of 97.1% and a technical success rate of 88.6%. The duration of the implant procedure, EndoAnchor implantation, and total fluoroscopy time was 148.0 ± 80.0 minutes, 17.1 ± 11.5 minutes, and 35.3 ± 22.0 minutes, respectively, and an average of 5.5 ± 2.1 EndoAnchors were implanted per patient. Through the 30-day follow-up, type IA endoleaks were reported in four patients, of which three resolved spontaneously by the 12-month follow-up. There was an additional type IA endoleak through the 12-month follow-up that has not resulted in AAA enlargement or required a secondary procedure. The Kaplan-Meier estimate for freedom from secondary endovascular procedures and all-cause mortality is 95.4% and 92.7% through 365 days, respectively. No patient in the short-neck cohort experienced main body stent migration, increase in maximum aneurysm diameter, or aneurysm rupture or required conversion to open surgical repair through 12 months. ConclusionsIn this analysis of the short-neck cohort from ANCHOR, the Endurant II/IIs endograft in conjunction with Heli-FX EndoAnchor implants (ESAR) appears to be a safe and effective treatment option with a high technical success rate and low incidence of type IA endoleaks and secondary interventions. Despite the complex and hostile anatomies, the ESAR method required short procedure and fluoroscopy times. These short-term outcomes suggest that ESAR could be complementary to therapies currently available for treatment of hostile AAA anatomy and a viable off-the-shelf endovascular treatment option for patients with short-neck AAAs, although long-term follow-up is critically important.
Background The mortality rate for renal artery bypass grafting (RABG) is reported to be 0% to 4% for patients with renovascular hypertension and 4% to 7% for patients with ischemic nephropathy. ...However, these data come from high-volume referral centers known for their expertise in treating these conditions. Because of the relative infrequency of these operations in most vascular surgery practices, the nationwide outcomes for RABG are not known. The purpose of this study was to define the operative mortality rate for RABG in the United States and to identify risk factors for perioperative mortality. Methods The National Inpatient Sample was analyzed to identify patients undergoing RABG for the years 2000 to 2004. Categoric data were analyzed using χ2 and the Cochran-Armitage trend tests. Multivariate logistic regression analyses were performed to identify risk factors for perioperative mortality after RABG. Results During the study period, 6608 patients underwent RABG, representing a frequency of 3.51 operations per 100,000 discharges. More than two-thirds were performed at teaching hospitals (4564 vs 2,044; P < .0001). The frequency of RABG decreased by 30.7% between 2000 and 2004 (4.28 vs 2.96 RABGs per 100,000 discharges; P for trend < .0001). The in-hospital mortality for RABG was 10.0%. On univariate analysis, in-hospital mortality after RABG varied with increasing age, race, region of the country, and a preoperative history of chronic renal failure, congestive heart failure, or chronic lung disease. Logistic regression models identified advanced age (odds ratio OR 1.57; 95% confidence interval CI, 1.44-1.72, female gender (OR, 1.20; 95% CI, 1.02-1.41), and a history of chronic renal failure (OR, 2.21; 95% CI, 1.75-2.78), congestive heart failure (OR, 1.94; 95% CI, 1.44-2.62), or chronic lung disease (OR, 1.40; 95% CI, 1.18-1.67) as independent markers of risk-adjusted, in-hospital mortality ( P < .0001 for each of these five variables). Conclusions Nationwide in-hospital mortality after RABG is higher than predicted by prior reports from high-volume referral centers. Advanced age, female gender, and a history of chronic renal failure, congestive heart failure, or chronic lung disease were predictive of perioperative death. For the typical vascular practice, these data may provide a rationale for lower risk alternatives, such as renal artery stenting or referral to high-volume referral centers for RABG.
Objective Proximal attachment site complications continue to occur after endovascular repair of abdominal aortic aneurysms (EVAR), specifically type Ia endoleak and endograft migration. EndoAnchors ...(Aptus Endosystems, Sunnyvale, Calif) were designed to enhance endograft proximal fixation and sealing, and the current study was undertaken to evaluate the potential benefit of this treatment. Methods During the 23-month period ending in December 2013, 319 subjects were enrolled at 43 sites in the United States and Europe. EndoAnchors were implanted in 242 patients (75.9%) at the time of an initial EVAR procedure (primary arm) and in 77 patients with an existing endograft and proximal aortic neck complications (revision arm). Technical success was defined as deployment of the desired number of EndoAnchors, adequate penetration of the vessel wall, and absence of EndoAnchor fracture. Procedural success was defined as technical success without a type Ia endoleak at completion angiography. Values are expressed as mean ± standard deviation and interquartile range. Results The 238 male (74.6%) and 81 female (25.4%) subjects had a mean age of 74.1 ± 8.2 years. Aneurysms averaged 58 ± 13 (51-63) mm in diameter at the time of EndoAnchor implantation (core laboratory measurements). The proximal aortic neck averaged 16 ± 13 (7-23) mm in length (42.7% <10 mm and 42.7% conical) and 27 ± 4 mm (25-30 mm) in diameter; infrarenal neck angulation was 24 ± 15 (13-34) degrees. The number of EndoAnchors deployed was 5.8 ± 2.1 (4-7). Technical success was achieved in 303 patients (95.0%) and procedural success in 279 patients (87.5%), 217 of 240 (89.7%) and 62 of 77 (80.5%) in the primary and revision arms, respectively. There were 29 residual type Ia endoleaks (9.1%) at the end of the procedure. During mean follow-up of 9.3 ± 4.7 months, 301 patients (94.4%) were free from secondary procedures. Among the 18 secondary procedures, eight were performed for residual type Ia endoleaks and the others were unrelated to EndoAnchors. There were no open surgical conversions, there were no aneurysm-related deaths, and no aneurysm ruptured during follow-up. Conclusions Use of EndoAnchors to treat existing and acute type Ia endoleaks and endograft migration was successful in most cases. Prophylactic use of EndoAnchors in patients with hostile aortic neck anatomy appears promising, but definitive conclusions must await longer term follow-up data.
Objective Prior studies have reported improved clinical outcomes with higher surgeon volume, which is assumed to be a product of the surgeon's experience with the index operation. We hypothesized ...that composite surgeon volume is an important determinant of outcome. We tested this hypothesis by comparing the impact of operation-specific surgeon volume versus composite surgeon volume on surgical outcomes, using open abdominal aortic aneurysm (AAA) repair as the index operation. Methods The Nationwide Inpatient Sample was analyzed to identify patients undergoing open AAA repairs for 2000 to 2008. Surgeons were stratified into deciles based on annual volume of open AAA repairs (“operation-specific volume”) and overall volume of open vascular operations (“composite volume”). Composite volume was defined by the sum of several open vascular operations: carotid endarterectomy, aortobifemoral bypass, femoral-popliteal bypass, and femoral-tibial bypass. Multiple logistic regression analyses were used to examine the relationship between surgeon volume and in-hospital mortality for open AAA repair, adjusting for both patient and hospital characteristics. Results Between 2000 and 2008, an estimated 111,533 (95% confidence interval CI, 102,296-121,232) elective open AAA repairs were performed nationwide by 6,857 surgeons. The crude in-hospital mortality rate over the study period was 6.1% (95% CI, 5.6%-6.5%). The mean number of open AAA repairs performed annually was 2.4 operations per surgeon. The mean composite volume was 5.3 operations annually. As expected, in-hospital mortality for open AAA repair decreased with increasing volume of open AAA repairs performed by a surgeon. Mortality rates for the lowest and highest deciles of surgeon volume were 10.2% and 4.5%, respectively ( P < .0001). A similar pattern was observed for composite surgeon volume, as the mortality rates for the lowest and highest deciles of composite volume were 9.8% and 4.8%, respectively ( P < .0001). After adjusting for patient and hospital characteristics, increasing composite surgeon volume remained a significant predictor of lower in-hospital mortality for open AAA repair (odds ratio, 0.994; 95% CI, .992-.996; P < .0001), whereas increasing volume of AAA repairs per surgeon did not predict in-hospital deaths. Conclusions The current study suggests that composite surgeon volume—not operation-specific volume—is a key determinant of in-hospital mortality for open AAA repair. This finding needs to be considered for future credentialing of surgeons.
Background The deep veins (DV) of the thigh have proven to be versatile autogenous conduits for arterial reconstruction. Harvesting DV poses a theoretical risk of compromising venous outflow of the ...limb, which could predispose to chronic venous morbidity. The purpose of this study was to define the late incidence of chronic venous insufficiency (CVI) and to characterize the long-term alterations in venous physiology after DV harvest. Methods Since 1991, 269 patients have undergone arterial reconstructions using DV at our facility. Patients with DV harvest at least 43 months prior to the study (n = 151) were eligible for inclusion. Eighty-nine patients were excluded (deceased = 70; lost to follow-up = 19). Forty-six patients who declined formal testing were queried by phone for signs and symptoms of CVI. The current study presents a case-control series of 16 patients (27 limbs) after DV harvest and six age- and gender-matched control patients (12 limbs) who underwent examination and venous testing. Results At a mean follow-up of 70.1 ± 5.6 months, 23 of 27 limbs (85.2%) had no significant CVI (CEAP C0 to C2 ). Four limbs (14.8%) had significant venous morbidity (C3 to C6 ), including edema alone (C3 ; n = 2 limbs), edema with skin changes (C4 ; n = 1 limb), and a healed venous ulceration (C5 ; n = 1 limb). APG testing confirmed relative venous outflow obstruction after DV harvest (mean outflow fraction: harvested limbs = 38.4 ± 3.9% vs control limbs = 51.7 ± 4.3%; P = .04). Despite the relative outflow obstruction, the mean VFI was not significantly different between harvested and control limbs (harvested limbs = 1.08 ± 0.15% vs control limbs = 0.77 ± 0.16%; P = .19). DV harvest resulted in no significant changes in calf ejection fraction (harvested limbs = 67.4 ± 6.4% vs control limbs = 86.8 ± 9.5%; P = .09) or residual volume fraction measured (harvested limbs = 32.3 ± 6.4% vs control limbs = 47.7 ± 11.6%; P = .22). Of the 46 patients interviewed by phone, five (10.9%) reported bilateral amputations, seven (15.2%) reported chronic edema in their harvested limbs (C3 ), and 34 (73.9%) reported no signs of CVI in their harvested limbs (C0 ). Conclusions Deep vein harvest produces few symptoms of chronic venous insufficiency, and venous ulceration is infrequent. Despite relative venous outflow obstruction, noninvasive indices of chronic venous insufficiency on APG are often normal, suggesting that the risk of developing venous ulceration is low in the majority of patients after DV harvest.
Background Type B aortic dissections are being successfully treated by thoracic endovascular aortic repair (TEVAR). Postoperative false lumen patency has been associated with aneurysmal dilatation ...and rupture of the thoracic aorta, necessitating further intervention. This is the first volumetric analysis of type B aortic dissections comparing patients with and without false lumen thrombosis (FLT) after TEVAR. We hypothesized that a greater increase in postoperative true lumen volume will lead to FLT, and without this change, false lumen patency will result. Methods Preoperative and postoperative computed tomography angiography (CTA) imaging was analyzed using three-dimensional reconstruction to measure the short- and long-axis diameter and cross-sectional area of the true lumen, false lumen, and total aorta. Measurements were taken at 5-cm intervals from the left subclavian artery to the aortic bifurcation. Pre- and postoperative volumetric data were calculated and compared in patients with and without postoperative FLT. Results Between 2006 and 2010, 132 patients underwent thoracic aortic stent grafting. Of these, 31 (23%) had thoracic endografting for type B aortic dissection. Pre- and postoperative CTA images were available for analysis in 23 patients with a mean age of 59 ± 14 years treated for acute, complicated (n = 8, 35%), and chronic (n = 15, 65%) indications. Mean follow-up imaging was 9 months (range, 1-39 months). Thirteen patients (56%) had postoperative FLT and 10 (43%) had persistent false lumen patency. The dissections involved the left subclavian artery (n = 12), visceral arteries (n = 14), renal arteries (n = 16), and iliac arteries (n = 15). The left subclavian artery was intentionally covered in 15 patients (65%). There were no significant differences in age, acute vs chronic dissection, branch vessel involvement, coverage of the left subclavian artery, or distal extent of the endograft between patients with and without postoperative FLT. Patients with postoperative FLT had a significantly smaller preoperative maximum thoracic aortic diameter (5.05 ± 1.0 vs 6.30 ± 1.4 cm; P = .02). Volumetric analysis demonstrated significantly smaller preoperative true lumen volume (141.3 ± 68 vs 230.5 ± 92 cm3 ; P = .01) in patients with FLT, but no difference in preoperative false lumen volume. Patients with FLT had a significant increase in the volume percentage of the true lumen from 42.7% to 61.7% ( P = .02) after stent graft repair, compared with an increase from 46.7% to 47.7% ( P = .75) in patients with persistent false lumen patency. Conclusions This volumetric study of type B aortic dissection treated with TEVAR suggests that the ability of the endograft to significantly increase the true lumen volume as a percent of the total aorta most accurately predicts postoperative FLT. This is best demonstrated in a nonaneurysmal dissection regardless of timing since dissection.
Objective The proximal aortic neck remains one of the challenges of endovascular aneurysm repair (EVAR), and the risk of type Ia endoleak and endograft migration is increased in patients with short, ...large-diameter, or highly angulated necks. EndoAnchors have been used as an adjunct to EVAR in such patients, and the aim of this study was to assess their benefit analyzed by indication for use. Methods During a 2-year period, 319 patients were enrolled at 43 sites in the Aneurysm Treatment Using the Heli-FX Aortic Securement System Global Registry (ANCHOR) study. This prospective, multinational, real-world analysis of EndoAnchors comprised two groups of patients, those undergoing first-time EVAR (primary arm, 242) and those with proximal neck complications remote from the time of an initial endograft implantation (revision arm, 77). The primary arm was further subdivided into patients undergoing prophylactic EndoAnchor use for hostile proximal neck anatomy (178), with a type Ia endoleak evident during initial endograft deployment (60), and in conjunction with extender cuffs after unsatisfactory endograft deployment distally in the neck (four). The revision arm was subdivided into patients presenting with a type Ia endoleak alone (45), endograft migration alone (11), and migration with endoleak (21). Technical success was site reported as satisfactory deployment of the desired number of EndoAnchors without fracture or loss of integrity. Procedural success was defined as technical success without type Ia endoleak at completion arteriography. Core laboratory analysis was performed on 249 baseline and 192 follow-up computed tomographic studies, 66 of which were available within the 1-year window. Results Technical and procedural success rates were highest in the prophylactically treated subset (172 of 178; 96.6%). Whereas the technical success of EndoAnchor deployment was also high in the other subsets, residual type Ia endoleaks were more frequent at completion angiography when the indication for EndoAnchor use was type Ia endoleak, both in the primary arm (17 of 60; 28%) and in the revision arm (9 of 45; 20%). During a median imaging follow-up of 7 months, 183 of 202 patients (90.1%) remained free of type Ia endoleaks. Primary prophylactic patients were free from type Ia endoleak in 110 of 114 cases (96.5%). The most challenging subset was revision patients treated for type Ia endoleak; type Ia endoleaks were evident during follow-up in 10 of 29 of the cases (34%). Sac regression >5 mm in patients with 1-year imaging was observed in 26 of 66 patients (39%) and was highest in the primary prophylaxis subset (20 of 43; 47%). Conclusions EndoAnchor implantation can be a useful adjunct to EVAR as prophylaxis against proximal attachment site complications in patients with hostile aortic neck anatomy, as treatment for early and late type Ia endoleaks, or, in conjunction with aortic extension cuffs, for endograft migration. Whereas the most challenging patients are those who present with type Ia endoleaks remote from initial EVAR, EndoAnchors are still effective in treating the majority of these cases.
Objective May-Thurner syndrome is characterized by left common iliac obstruction secondary to compression of the left iliac vein by the right common iliac artery against the fifth-lumbar vertebra. ...This anatomic variant results in an increased incidence of left-sided deep venous thrombosis (DVT). Furthermore, while a preponderance of left-sided DVT has been demonstrated in women during pregnancy and oral contraceptive use, patients are not typically screened for this condition after developing a left-sided DVT. As anticoagulation alone is ineffective for DVT treatment in the setting of May-Thurner anatomy, more aggressive treatment is warranted. Failure to diagnosis this condition predisposes these women to the unnecessary risks of recurrent DVT and post-thrombotic syndrome. Methods We present the occurrence of 7 adolescent patients with previously undiagnosed May-Thurner syndrome who presented with DVT after the initiation of oral contraceptive steroids (OCP) use. All 7 patients elected to proceed with mechanical thrombolysis/catheter based thrombolysis followed by endovascular stenting and were postoperatively treated with 6 months of warfarin. Results Mean patient age was 18.3 ± 3.3 years (range, 16-24 years). Mean time to presentation after initiation of OCP was 5 weeks (range, 2-10 weeks). Mean time to intervention was 16.8 days (range, 10-24 days). All patients were treated with mechanical thrombectomy. Our rate of intraoperative clot resolution was 100%. All 7 patients were treated with self expanding nitinol stents after angioplasty of the iliac vein stenosis with resolution of the stenotic segment. Primary stent patency is 100% (7/7). Mean follow-up time is 13 ± 13.84 months (range, 6-42 months). There have been no long-term complications related to surgical treatment or anticoagulation. All 7 patients have experienced resolution of left leg swelling and pain and have no evidence of post-thrombotic syndrome or DVT recurrence to date. Conclusions Women on OCPs presenting with left-sided iliofemoral DVT should be screened for hypercoagulable disorders and underlying May-Thurner anatomy. Treatment of May-Thurner syndrome should include thrombolysis/thrombectomy and anticoagulation for current DVT in addition to angioplasty and stenting of the underlying obstruction.
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