Gore thoracoabdominal branched endoprosthesis: early results and impressions.

The remarkable advances in technology and devices in the last two decades have made possible the endovascular repair of complex abdominal (cAAA) and thoracoabdominal (TAAA) aortic aneurysms with challenging anatomy. To date, despite the creation of multiple fenestrated/branched endografts intended to treat these difficult cases, in the USA, many of them remain available only under physician sponsored investigational device exemption (PSIDE) protocols in few institutions. The Gore Thoracoabdominal Branched Endoprosthesis (TAMBE; W.L. Gore & Associates, Flagstaff, AZ, USA) investigational device is a four-branched off-the-shelf (OTS) endograft that concluded an early feasibility study in 2016 and is currently finalizing a pivotal trial in pursuit of approval from the Food and Drug Administration. This article discusses the TAMBE early feasibility multicenter study results, the most relevant features of this device, its anatomical feasibility, and the impressions about this endograft as an OTS option for the treatment of CAAA and TAAA.

Analysis of wound healing time and wound-free period in patients with chronic limb-threatening ischemia treated with and without revascularization.

BACKGROUND: The traditionally reported outcomes for patients with ischemic wounds have centered on amputation-free survival. However, that discounts the importance of other patient-centered outcomes such as the wound healing time (WHT) and wound-free period (WFP). We evaluated the long-term wound outcomes of patients treated for chronic limb-threatening ischemia at our institution. METHODS: From 2014 to 2017, we identified all patients with chronic limb-threatening ischemia and ischemic wounds using symptomatic and hemodynamic criteria. The primary data included the wound size, wound location, WIfI (wound, ischemia, foot infection) grade, WHT, WFP, minor and major amputation, and death. Wounds were not considered healed if the patient had required a major amputation or had died before wound healing. The WHT was calculated as the interval in days between the diagnosis and determination of a healed wound. The WFP was calculated as the interval in days between a healed wound and wound recurrence, major amputation, death, or the end of the study period. A comparison of the wound healing parameters stratified by revascularization status was performed using the Student t test. A generalized linear model adjusted for age, sex, initial wound size, and WIfI grade was used to evaluate the risk of wound healing with and without revascularization. RESULTS: A total of 256 patients had presented with 372 wounds. Of the 256 patients, 48% had undergone revascularization. During the study period, 97 minor amputations and 100 major amputations had been required, and 132 patients had died. The average wound size was 13.9 ± 52.0 cm2; however, for the 155 wounds that had healed, the average size was only 4.0 ± 9.6 cm2 (P = .002). No differences were found in the wound size when stratified by revascularization status (P = .727). Adjusted for the initial wound size, the risk of wound healing was not different when stratified by revascularization (risk ratio, 1.22; 95% confidence interval, 0.80-1.87; P = .354). For those whose wounds had healed, the average WHT and WFP were 173 ± 169 days and 775 ± 317 days, respectively. The WHT was not faster for the revascularized group (155 days vs 188 days; P = .221). When stratified by revascularization status, the rate of wound recurrence was 4.6 vs 8.9 wounds per 100 person-years for the revascularized and nonrevascularized groups, respectively (P = .125). CONCLUSIONS: In our study, we found that, except for patients who presented with severe ischemia, revascularization was not associated with improved rates of wound healing. Among the wounds that healed, regardless of the initial ischemia grade, revascularization was not associated with a faster WHT or longer WFPs.

Gender Disparities in Aortoiliac Revascularization in Patients with Aortoiliac Occlusive Disease.

BACKGROUND: Gender disparities have been previously reported in aortic aneurysm and critical limb ischemia outcomes; however, limited info is known about disparities in aortoiliac occlusive disease. We sought to characterize potential disparities in this specific population. MATERIAL AND METHODS: Patients who underwent aortobifemoral bypass and aortic thromboendarterectomy (Current Procedural Terminology codes 35646 and 35331) between 2012 and 2019 were identified in the National Surgical Quality Improvement Program database. A binomial regression model was used to estimate gender differences in 30-day morbidity and mortality. Inverse probability weighting was used to standardize demographic and surgical characteristics. RESULTS: We identified 1,869 patients, of which 39.8% were female and the median age was 61 years. Age, body composition, and other baseline characteristics were overall similar between genders; however, racial data were missing for 26.1% of patients. Females had a higher prevalence of preexisting chronic obstructive pulmonary disease (20.9% vs. 14.7%, prevalence difference 6.1%, P < 0.01), diabetes mellitus (25.4% vs. 19.4%, prevalence difference 6.0%, P < 0.01), and high-risk anatomical features (39.4% vs. 33.7%, prevalence difference 5.8%, P = 0.01). Preprocedural medications included a statin in only 68.2% of patients and antiplatelet agent in 76.7% of patients. Females also had a higher incidence of bleeding events when compared to males (25.2% vs. 17.5%, standardized risk difference 7.2%, P < 0.01), but were less likely to have a prolonged hospitalization greater than 10 days (18.2% vs. 20.9%, standardized risk difference -5.0%, P = 0.01). The 30-day mortality rate was not significantly different between genders (4.7% vs. 3.6%, standardized risk difference 1.2%, P = 0.25). CONCLUSIONS: Female patients treated with aortobifemoral bypass or aortic thromboendarterectomy are more likely to have preexisting chronic obstructive pulmonary disease, diabetes mellitus, and high-risk anatomical features. Regardless of a patient's gender, there is poor adherence to preoperative medical optimization with both statins and antiplatelet agents. Female patients are more likely to have postoperative bleeding complications while males are more likely to have a prolonged hospital stay greater than 10 days. Future work could attempt to further delineate disparities using databases with longer follow-up data and seek to create protocols for reducing these observed disparities.

Iliac conduits remain safe in complex endovascular aortic repair.

OBJECTIVE: Iliac conduits (ICs) are used for challenging iliac access during endovascular aortic aneurysm repair (EVAR) with contradictory reports of safety and increased surgical complications, morbidity, and mortality in national database reviews. The objective of this study was to examine outcomes related to IC placement before or concomitant with EVAR at a high-volume single center. METHODS: A retrospective analysis of patients who underwent IC placement for endovascular aortic repair from 2006 to 2016 was conducted. Planned and unplanned, as well as staged and concomitant IC for EVAR, thoracic EVAR, and fenestrated/branched EVAR were included. Categorical factors were described using frequencies and percentages. Continuous measures were summarized in comparative tables. Comparisons between the planned and unplanned groups, concomitant and staged groups, and between those with and without a postoperative event were performed using Pearson χ2 tests, two-sample t-tests, and Wilcoxon rank-sum tests. RESULTS: A total of 137 patients underwent IC placement, of which 9 were bilateral procedures, for a total of 144 IC placements. IC placement was necessary in 14 EVARs (9.7%), 38 thoracic EVARs (26.4%), and 92 fenestrated/branched EVARs (63.9%). The 30-day related mortality was 2.1% (n = 3). Perioperative morbidities included return to the operating room in five patients (5.6%) for bleeding (n = 4) and graft thrombosis (n = 1), 4 myocardial infarctions (2.8%), 5 episodes of respiratory failure (3.5%), 12 wound complications (8.3%), and 7 renal injuries (4.9%), of which 3 had progression to dialysis (2.1%). Other complications included return to the operating room for endoleak reintervention (n = 3) and late graft infection (n = 1 [0.7%]). There were 112 ICs (77.8%) planned and 65 (45.1%) were staged. Staged ICs were less likely to have postoperative complications (P < .001), respiratory failure (P < .05), infectious complications (P < .05), and postoperative cerebrovascular accidents (P < .05). ICs were done to accommodate 20F to 24F sheath sizes in 131 instances (91.0%). Factors associated with unplanned IC placement were iliac rupture and an inability to advance the endograft in arteries deemed size-appropriate preoperatively (P < .001). Unplanned ICs were associated with higher estimated blood loss (P < .001), operating room transfusion volume (P < .001), and overall complication rates (P < .05). Women (P < .05), preoperative chronic kidney disease (P < .05), and concomitant IC placement (P < .001) were associated with higher overall complication rates. Operative time, estimated blood loss, and operating room transfusion volume were associated with increased rate of complications in comparison between all subgroups (P < .05). CONCLUSIONS: ICs are a safe and viable option for high-risk patients with challenging iliac artery access for EVVAR. ICs are best performed in a planned fashion or in a staged manner, when feasible.

Staged repair of thoracoabdominal aneurysm with infra-renal elephant trunk graft.

A patient with residual thoracoabdominal aortic aneurysm and chronic dissection extending into the branch iliac arteries underwent staged open and endovascular repair. Open repair of the reno-visceral segment was performed with an "elephant trunk" trunk graft placed distally into a 12-cm infra-renal aorta. One month later, the patient underwent a successful completion endovascular aortic repair. This case demonstrates the utility of combining traditional and endovascular surgery to manage complex aortic pathologies.

Iliac injury during abdominal and thoracic aortic endovascular intervention.

OBJECTIVE: Iliac injury is a devastating and potentially avoidable complication of endovascular aortic intervention. To our knowledge, this study is the first investigation of demographic, anatomic, and device factors related to injury in vascular surgery patients. METHODS: We retrospectively examined 1859 endovascular aortic interventions and found 42 iliac injuries, including 21 ruptures. Demographic, anatomic, and device data were extracted from these patients and a cohort of 200 case-matched control patients derived from the group of uninjured patients. Anatomic data include centerline and straight distance measurement of the iliac system from the aortic bifurcation to the inguinal ligament. The ratio of the two ("tortuosity index") was calculated. Additional data include midpoint and narrowest diameters in the iliac system along with the most acute angle. Each measurement was taken on both limbs of each patient. RESULTS: Nonwhite race was the only demographic factor associated with injury (P = .028). None of the examined comorbidities were associated with iliac injury. Increasing sheath size was associated with injury (P < .001), whereas abdominal aortic segment intervention was inversely correlated with injury (P = .017). Anatomic factors that correlated with injury were decreasing iliac midpoint (P < .01), narrowest diameters (P < .001), and a higher ratio of sheath size to midpoint diameter (P < .001). Injury was associated with a longer hospital length of stay (P = .042) and inpatient death (P < .001), with iliac rupture conferring an odds ratio of 15.3 (95% confidence interval, 3.74-62.7; P < .001). CONCLUSIONS: Iliac injury is associated with an increased hospital length of stay and death on the index admission. Nonwhite race, nonabdominal aortic segment intervention, larger relative and absolute sheath sizes, and smaller iliac artery diameters are associated with iliac injury. These findings should be prospectively evaluated along with interventions to reduce injury.

The value of anecdote.

Anecdote is defined as "a usually short narrative of an interesting, amusing, or biographical incident" and are not often deemed scientifically valuable (www.merriam-webster.com). Anecdotes can be analyzed, however, and those observations can become the initiation of important and groundbreaking work. In this article, we describe aecdotes of several cases which by themselves had seemingly little value. The value was added later, when these concepts were extrapolated to important projects, which expanded into series of experiences, which were reproducible and able to be analyzed and judged as valuable devices and/or methods. The authors recognize that some of the images are old and not of great quality but the information provided is as complete as possible and reliable.

Minimizing complications of carotid stenting.

Results of carotid artery stenting (CAS) are directly related to the experience and skills of the operator. The most dreadful complication of CAS is stroke. Analyzing the complications during the authors' own procedures, they came to the conclusion that most, if not all, of the complications are preventable. Attention to details is crucial, and it involves having the appropriate wires, catheters, balloons, stents, and cerebral protection devices readily available.

Oral administration of diferuloylmethane (curcumin) suppresses proinflammatory cytokines and destructive connective tissue remodeling in experimental abdominal aortic aneurysms.

Chronic transmural inflammation and proteolytic destruction of medial elastin are key mechanisms in the development of abdominal aortic aneurysms (AAAs). Diferuloylmethane (curcumin) is a major component of the food additive tumeric, which has been shown to have anti-inflammatory properties. To determine if ingestion of curcumin influences aneurysmal degeneration, C57Bl/6 mice underwent transient elastase perfusion of the abdominal aorta to induce the development of AAAs, followed by daily oral gavage with 100 mg/kg curcumin (n = 36) or water alone (n = 31). By 14 days, mice in the control group developed a mean increase in aortic diameter of 162.8 +/- 4.6% along with a dense mononuclear inflammation and destruction of medial elastin. By comparison, the mean increase in aortic diameter in the curcumin-treated group was only 133.2 +/- 5.2% (p < 0.0001). Although aortic wall inflammation was similar between the groups, the structural integrity of medial elastin was significantly greater in curcumin-treated mice. Curcumin-treated mice also exhibited relative decreases in aortic tissue activator protein-1 and nuclear factor kappaB DNA binding activities and significantly lower aortic tissue concentrations of interleukin-1beta (IL-1beta), IL-6, monocyte chemoattractant protein-1, and matrix metalloproteinase-9 (all p < 0.05). These data demonstrate for the first time that oral administration of curcumin can suppress the development of experimental AAAs, along with structural preservation of medial elastin fibers and reduced aortic wall expression of several cytokines, chemokines, and proteinases known to mediate aneurysmal degeneration. The possibility that dietary ingestion of curcumin may have a beneficial effect in degenerative aortic aneurysms warrants further consideration.

Localized administration of doxycycline suppresses aortic dilatation in an experimental mouse model of abdominal aortic aneurysm.

Treatment with doxycycline suppresses the development of abdominal aortic aneurysms (AAAs) in experimental animal models, but its use in humans can be accompanied by dose-related side effects. We sought to determine if localized administration of doxycycline can achieve inhibition of AAAs equivalent to that achieved by systemic treatment. C57BL/6 mice underwent transient elastase perfusion of the abdominal aorta to induce the development of AAAs. After 14 days, the mean increase in aortic diameter was reduced from 167.2+/-7.8% in untreated mice to only 129.7+/-13.8% in mice treated with 100 mg/kg/day oral doxycycline (p<0.05). Using osmotic minipumps to provide continuous periaortic infusion of doxycycline, localized infusion at rates of 0.75 to 1.0 mg/kg/day suppressed AAAs to an equivalent or even greater extent than systemic treatment [mean increase in aortic diameter 131.5+/-14.4% at 0.75 mg/kg/day, p<0.05; 103.2+/-13.5% at 1.0 mg/kg/day, p<0.01). Mean plasma doxycycline levels reached 332+/- 62 ng/mL during oral administration, but the drug was undetectable in the circulation during localized infusion. The doxycycline concentration in aortic tissue extracts was 22+/- 6 ng/mL during systemic treatment compared to only 5.6+/- 2.2 ng/mL [at 0.75 mg/kg/day] and 7.8+/- 4.0 ng/mL [at 1.0 mg/kg/day] during localized infusion (p<0.05). Localized administration of doxycycline can effectively suppress experimental AAAs with undetectable plasma drug levels, even at doses 100-fold lower than those used during oral drug administration. Localized delivery of doxycycline holds promise as a novel strategy to inhibit the progressive expansion of aortic aneurysms, perhaps as a pharmacological adjunct to endovascular (stent graft) treatment.

Suppression of experimental abdominal aortic aneurysms in mice by treatment with pyrrolidine dithiocarbamate, an antioxidant inhibitor of nuclear factor-kappaB.

OBJECTIVE: Proinflammatory cytokines and matrix metalloproteinases (MMPs) are prominent mediators of the connective tissue destruction that characterizes abdominal aortic aneurysms (AAAs), and nuclear factor (NF)-kappaB is a cytokine-responsive transcription factor that promotes macrophage MMP expression. The purpose of this study was to determine whether aneurysmal degeneration is influenced by pyrrolidine dithiocarbamate (PDTC), a pharmacologic inhibitor of NF-kappaB. METHODS: Adult male C57BL/6 mice underwent transient elastase perfusion of the abdominal aorta to induce the development of AAAs. Animals were treated every 48 hours by intraperitoneal injection with either saline (n = 34) or PDTC 20 mg/kg (n = 49). Aortic diameter (AD) measurements were used to determine the extent of aortic dilatation before and immediately after elastase perfusion and again at day 14. RESULTS: All saline-treated mice developed AAAs associated with mononuclear inflammation and destruction of medial elastin (overall increase in AD, mean +/- SEM, 169.1% +/- 7.5%). In contrast, the incidence of AAAs was only 63% in PDTC-treated mice, with a reduction in the overall increase in AD to 109.8% +/- 4.2% ( P < .0001 vs saline), decreased inflammation, and structural preservation of aortic wall connective tissue. Although aneurysm development in saline-treated mice was associated with a marked increase in aortic tissue NF-kappaB and activator protein 1 DNA-binding activities, both activities were substantially reduced in PDTC-treated animals. PDTC-treated mice also exhibited significantly lower serum and aortic wall concentrations of interleukin 1beta and interleukin 6, as well as lower amounts of aortic wall MMP-9, as compared with saline-treated controls. CONCLUSIONS: Treatment with PDTC inhibits elastase-induced experimental AAAs in the mouse, along with suppression of aortic wall NF-kappaB and activator protein 1 transcription factor activities, reduced expression of proinflammatory cytokines, and suppression of MMP-9. NF-kappaB is therefore a potentially important therapeutic target for the suppression of aneurysmal degeneration. CLINICAL RELEVANCE: Development and progression of human AAAs is associated with inflammation and enzymatic degradation of connective tissue proteins. MMP-9 is one of the enzymes involved in aneurysm disease, and its production may be induced in part by activation of the transcription factor NF-kappaB. In this mouse model, treatment with pyrrolidine dithiocarbamate (a pharmacologic inhibitor of NF-kappaB) acted to suppress MMP-9 and aneurysm development. It is hoped that treatment strategies that target NF-kappaB may eventually be shown to suppress the growth of small aortic aneurysms in patients.