Prospective randomized pilot trial comparing prophylactic and therapeutic cerebrospinal fluid drainage during complex endovascular thoracoabdominal aortic aneurysm repair.

BACKGROUND: Endovascular techniques have transformed the management of thoracoabdominal aortic aneurysms (TAAAs). However, spinal cord ischemia (SCI) remains a prevalent and devastating complication. Prophylactic drainage of cerebrospinal fluid (CSF) is among the proposed strategies for prevention of SCI. Although prophylactic CSF drainage is widely used and conceptually attractive, prophylactic CSF drains have not been demonstrated to definitively prevent the occurrence nor mitigate the severity of SCI in endovascular TAAA repair. Whether or not outcomes of prophylactic drains are superior to therapeutic drains remains unknown. This pilot study was performed to determine the feasibility of a randomized clinical trial designed to investigate the role of prophylactic vs therapeutic CSF drains in the prevention of SCI in patients undergoing endovascular TAAA repair using branched and fenestrated endovascular aortic repair (FBEVAR). METHODS: This was a prospective multicenter randomized pilot clinical trial conducted at The University of Alabama at Birmingham and The University of Massachusetts. Twenty patients were enrolled and randomized to either the prophylactic drainage or therapeutic drainage groups, prior to undergoing FBEVAR for extensive TAAAs and arch aortic aneurysms. This was a pilot feasibility study that was not powered to detect statistical differences in clinical outcomes. The primary outcome was feasibility of randomization and compliance with a shared lumbar drain protocol. Secondary outcomes included rate of drain complications and SCI. RESULTS: Twenty patients were enrolled and successfully randomized, without any crossovers, to either the control cohort (n = 10), without prophylactic drains, or the experimental cohort (n = 10), with prophylactic drains. There were no differences in age, comorbidities, or history of prior aortic surgery across the cohorts. All patients were treated with FBEVAR. Aneurysm classifications were as follows: Extent I (10%), Extent II (50%), Extent III (35%), and Extent IV (5%). The average length of aortic coverage was 207 ± 21.6 mm. The length of aortic coverage did not vary across cohorts, nor did procedural times or blood loss volume. Compliance with the SCI prevention protocol was 100% across both groups. Within the prophylactic drain cohort, one patient experienced an adverse event related to lumbar drain placement, manifested as an epidural hematoma requiring laminectomy, without neurologic deficit (n = 1/10; 10%). There was one SCI event (n = 1/20; 5%), which occurred in the prophylactic drain cohort on postoperative day 9 following an episode of hypotension related to a gastrointestinal bleed. CONCLUSIONS: The role of prophylactic CSF drains for the prevention of SCI following endovascular TAAA repair is a topic of ongoing research, with many current practices based on expert opinion and experience, rather than rigorous scientific data. This study demonstrates the feasibility of a multicenter randomized clinical trial to evaluate the role of prophylactic vs therapeutic CSF drains in the prevention of SCI in patients undergoing endovascular TAAA repair.

Practice patterns of antiplatelet and anticoagulant therapy after fenestrated/branched endovascular aortic repair.

OBJECTIVE: Antiplatelet and/or anticoagulant therapy are commonly prescribed after fenestrated/branched endovascular aortic repair (F/BEVAR). However, the optimal regimen remains unknown. We sought to characterize practice patterns and outcomes of antiplatelet and anticoagulant use in patients who underwent F/BEVAR. METHODS: Consecutive patients enrolled (2012-2023) as part of the United States Aortic Research Consortium (US-ARC) from 10 independent physician-sponsored investigational device exemption studies were evaluated. The cohort was characterized by medication regimen on discharge from index F/BEVAR: (1) Aspirin alone OR P2Y12 alone (single-antiplatelet therapy [SAPT]); (2) Anticoagulant alone; (3) Aspirin + P2Y12 (dual-antiplatelet therapy [DAPT]); (4) Aspirin + anticoagulant OR P2Y12 + anticoagulant (SAPT + anticoagulant); (5) Aspirin + P2Y12 + anticoagulant (triple therapy [TT]); and (6) No therapy. Kaplan-Meier analysis and Cox proportional hazards modeling were used to compare 1-year outcomes including survival, target artery patency, freedom from bleeding complication, freedom from all reinterventions, and freedom from stent-specific reintervention. RESULTS: Of the 1525 patients with complete exposure and outcome data, 49.6% were discharged on DAPT, 28.8% on SAPT, 13.6% on SAPT + anticoagulant, 3.2% on TT, 2.6% on anticoagulant alone, and 2.2% on no therapy. Discharge medication regimen was not associated with differences in 1-year survival, bleeding complications, composite reintervention rate, or stent-specific reintervention rate. However, there was a significant difference in 1-year target artery patency. On multivariable analysis comparing with SAPT, DAPT conferred a lower hazard of loss of target artery patency (hazard ratio [HR], 0.48; 95% confidence interval [CI], 0.27-0.84; P = .01). On sub-analyses of renal stents alone or visceral stents alone, DAPT no longer had a significantly lower hazard of loss of target artery patency (renal: HR, 0.66; 95% CI, 0.35-1.27; P = .22; visceral: HR, 0.31; 95% CI, 0.05-1.9; P = .21). Lastly, duration of DAPT therapy (1 month, 6 months, or 1 year) did not significantly affect target artery patency. CONCLUSIONS: Practice patterns for antiplatelet and anticoagulant regimens after F/BEVAR vary widely across the US-ARC. There were no differences in bleeding complications, survival or reintervention rates among different regimens, but higher branch vessel patency was noted in the DAPT cohort. These data suggest there is a benefit in DAPT therapy. However, the generalizability of this finding is limited by the retrospective nature of this data, and the clinical significance of this finding is unclear, as there is no difference in survival, bleeding, or reintervention rates amongst the different regimens. Hence, an "optimal" regimen, including the duration of such regimen, could not be clearly discerned. This suggests equipoise for a randomized trial, nested within this cohort, to identify the most effective antiplatelet/anticoagulant regimen for the growing number of patients being treated globally with F/BEVAR.

Severity of acute kidney injury is associated with decreased survival after fenestrated and branched endovascular aortic aneurysm repair.

OBJECTIVE: Acute kidney injury (AKI) occurs frequently in complex aortic surgery and has been implicated in perioperative and long-term survival. This study sought to characterize the relationship between AKI severity and mortality after fenestrated and branched endovascular aortic aneurysm repair (F/B-EVAR). METHODS: Consecutive patients enrolled by the US Aortic Research Consortium in 10, prospective, nonrandomized, physician-sponsored investigational device exemption studies evaluating F/B-EVAR, between 2005 and 2023, were included in this study. Perioperative AKI during hospitalization was defined by and staged using the 2012 Kidney Disease Improving Global Outcomes criteria. Determinants of AKI were evaluated with backward stepwise mixed effects multivariable ordinal logistic regression. Survival was analyzed with conditionally adjusted survival curves and backward stepwise mixed effects Cox proportional hazards modelling. RESULTS: In the study period, 2413 patients with a median (interquartile range [IQR]) age of 74 years (IQR, 69-79 years) underwent F/B-EVAR. The median follow-up duration was 2.2 years (IQR, 0.7-3.7 years). The median baseline estimated glomerular filtration rate (eGFR) and creatinine were 68 mL/min/1.73 m2 (IQR, 53-84 mL/min/1.73 m2) and 1.1 mg/dL (IQR, 0.9-1.3 mg/dL), respectively. Stratification of AKI identified 316 patients (13%) with stage 1 injury, 42 (2%) with stage 2 injury, and 74 (3%) with stage 3 injury. Renal replacement therapy was initiated during the index hospitalization in 36 patients (1.5% of cohort, 49% of stage 3 injuries). Thirty-day major adverse events were associated with AKI severity (all P ≤ .0001). Multivariable predictors of AKI severity included baseline eGFR (proportional odds ratio, 0.9 per 10 mL/min/1.73 m2 [95% confidence interval (CI), 0.85-0.95 per 10 mL/min/1.73 m2]; P < .0001), baseline serum hematocrit (0.58 per 10% [95% CI, 0.48-0.71 per 10%]; P < .0001), renal artery technical failure during aneurysm repair (3 [95% CI,1.61-5.72]; P = .0006), and total operating time (1.05 per 10 minutes [95% CI, 1.04-1.07 per 10 minutes]; P < .0001). One-year unadjusted survivals for AKI severity strata were 91% (95% CI, 90%-92%) for no injury, 80% (95% CI, 76%-85%) for stage 1 injury, 72% (95% CI, 59-87%) for stage 2 injury, and 46% (95% CI, 35-59%) for stage 3 injury (P<.0001). Multivariable determinants of survival included AKI severity (stage 1, hazard ratio [HR], 1.6 [95% CI, 1.3-2]); stage 2, HR, 2.2 [95% CI, 1.4-3.4]); stage 3 HR, 4 [95% CI, 2.9-5.5]; P < .0001), decreased eGFR (HR, 1.1 [95% CI, 0.9-1.3]; P = .4), patient age (HR, 1.6 per 10 years [95% CI, 1.4-1.8 per 10 years]; P < .0001), baseline chronic obstructive pulmonary disease (HR, 1.5 [95% CI, 1.3-1.8]; P < .0001), baseline congestive heart failure (HR, 1.7 [95% CI, 1.6-2.1]; P < .0001), postoperative paraplegia (HR, 2.1 [95% CI, 1.1-4]; P = .02), and procedural technical success (HR, 0.6 [95% CI, 0.4-0.8]; P = .003). CONCLUSIONS: AKI, as defined by the 2012 Kidney Disease Improving Global Outcomes criteria, occurred in 18% of patients after F/B-EVAR. Greater severity of AKI after F/B-EVAR was associated with decreased postoperative survival. The predictors of AKI severity identified in these analyses suggest a role for improved preoperative risk mitigation and staging of interventions in complex aortic repair.

Utility of Continuous Paravertebral Block After Retroperitoneal Abdominal Aortic Aneurysm Repair.

BACKGROUND: Open abdominal aortic aneurysm (AAA) repairs can be associated with significant pain and morbidity. Previous studies have demonstrated utility of adjunctive epidural analgesia (EA) in addition to general anesthesia (GA) to reduce pain and blunt the maladaptive surgical stress response. However, EA may be complicated by epidural hematomas and severe hypotension. Recently, we started using continuous paravertebral block (PVB) for perioperative analgesia after retroperitoneal AAA repair. PVB has some distinct advantages over EA such as unilateral localization, reduced risk of hypotension, and minimal risk of epidural hematoma in the setting of systemic heparinization. This study aimed to examine the utility of PVB by comparing total opioid consumption in the postoperative period among patients who received GA + PVB and those who received GA alone. METHODS: This retrospective matched cohort study included 62 patients who underwent elective retroperitoneal AAA repair between January 2019 and August 2022. Thirty-one subjects managed with GA + PVB were compared with 31 control subjects treated with GA alone, matched on following criteria: age, sex, and cross-clamp location. Outcome measures included total opioid analgesics administered during their inhospital postoperative course, time to extubation, time to return to baseline activity, time to normal bowel function, and length of stay. Opioid doses were converted to morphine milligram equivalents (MMEs). RESULTS: The GA + PVB group required significantly less opioid analgesics (81 ± 53 MME) than the GA group (171 ± 121 MME) (P < 0.001). Compared to GA alone, GA + PVB was superior in every clinical metric examined: time to extubation (3 vs. 1 hr, P < 0.001), recovery of bowel function (3 vs. 2 days, P = 0.002), recovery of baseline physical activity (4 vs. 2 days, P = 0.019), and length of stay (5 vs. 3 days, P < 0.001). CONCLUSIONS: Continuous paravertebral block provides better pain management with significantly decreased opioid requirements in the postoperative period compared to GA-alone for patients undergoing elective retroperitoneal AAA repair.

A Hybrid Approach in the Management of a Large Pancreaticoduodenal Artery Aneurysm.

Pancreaticoduodenal artery aneurysms (PDAA) are rare and represent a small fraction of known visceral aneurysms. We describe a case of a 79-year-old male with an 82 mm PDAA in the setting of chronic celiac artery occlusion. The patient was treated with an open repair. Due to the large size of the aneurysm and the dense adhesions to the surrounding tissues, vascular control of the superior mesenteric artery (SMA) was achieved by endovascular balloon occlusion and the aneurysm repaired with resection and primary aneurysmorrhaphy. The patient had an uneventful postoperative course.

Total endovascular aortic arch repair using the Terumo Aortic triple-branch arch endograft.

OBJECTIVE: To evaluate the feasibility and outcomes of total endovascular repair of aortic arch aneurysms using a novel triple-branch arch endograft. METHODS: Retrospective review of the clinical data and outcomes of 3 patients with arch aneurysms treated at a single institution using a custom-made triple-branch aortic endograft (Terumo Aortic, Sunrise, FL) between 2015 and 2020. The device has 3 internal branches corresponding to the principal branches of the standard aortic arch, obviating the need for any surgical revascularization. This initial experience represents the first three cases ever performed in the world using this endograft. RESULTS: All procedures were technically successful. There were no strokes, in-hospital, or 1 year mortality. All 3 patients required secondary re-interventions. One patient died 14 months after the index procedure due to endocarditis unrelated to the arch repair. CONCLUSION: The initial experience with the Terumo Aortic triple-branch endograft for treatment aortic arch aneurysms showed that, while the procedure is technically feasible, there remain significant anatomic and mechanical challenges in the endovascular repair of this segment of the thoracic aorta. Further refinements of endograft design and identification of optimal bridging stent technology are needed.

The Society for Vascular Surgery practice guidelines on the care of patients with an abdominal aortic aneurysm.

BACKGROUND: Decision-making related to the care of patients with an abdominal aortic aneurysm (AAA) is complex. Aneurysms present with varying risks of rupture, and patient-specific factors influence anticipated life expectancy, operative risk, and need to intervene. Careful attention to the choice of operative strategy along with optimal treatment of medical comorbidities is critical to achieving excellent outcomes. Moreover, appropriate postoperative surveillance is necessary to minimize subsequent aneurysm-related death or morbidity. METHODS: The committee made specific practice recommendations using the Grading of Recommendations Assessment, Development, and Evaluation system. Three systematic reviews were conducted to support this guideline. Two focused on evaluating the best modalities and optimal frequency for surveillance after endovascular aneurysm repair (EVAR). A third focused on identifying the best available evidence on the diagnosis and management of AAA. Specific areas of focus included (1) general approach to the patient, (2) treatment of the patient with an AAA, (3) anesthetic considerations and perioperative management, (4) postoperative and long-term management, and (5) cost and economic considerations. RESULTS: Along with providing guidance regarding the management of patients throughout the continuum of care, we have revised a number of prior recommendations and addressed a number of new areas of significance. New guidelines are provided for the surveillance of patients with an AAA, including recommended surveillance imaging at 12-month intervals for patients with an AAA of 4.0 to 4.9 cm in diameter. We recommend endovascular repair as the preferred method of treatment for ruptured aneurysms. Incorporating knowledge gained through the Vascular Quality Initiative and other regional quality collaboratives, we suggest that the Vascular Quality Initiative mortality risk score be used for mutual decision-making with patients considering aneurysm repair. We also suggest that elective EVAR be limited to hospitals with a documented mortality and conversion rate to open surgical repair of 2% or less and that perform at least 10 EVAR cases each year. We also suggest that elective open aneurysm repair be limited to hospitals with a documented mortality of 5% or less and that perform at least 10 open aortic operations of any type each year. To encourage the development of effective systems of care that would lead to improved outcomes for those patients undergoing emergent repair, we suggest a door-to-intervention time of <90 minutes, based on a framework of 30-30-30 minutes, for the management of the patient with a ruptured aneurysm. We recommend treatment of type I and III endoleaks as well as of type II endoleaks with aneurysm expansion but recommend continued surveillance of type II endoleaks not associated with aneurysm expansion. Whereas antibiotic prophylaxis is recommended for patients with an aortic prosthesis before any dental procedure involving the manipulation of the gingival or periapical region of teeth or perforation of the oral mucosa, antibiotic prophylaxis is not recommended before respiratory tract procedures, gastrointestinal or genitourinary procedures, and dermatologic or musculoskeletal procedures unless the potential for infection exists or the patient is immunocompromised. Increased utilization of color duplex ultrasound is suggested for postoperative surveillance after EVAR in the absence of endoleak or aneurysm expansion. CONCLUSIONS: Important new recommendations are provided for the care of patients with an AAA, including suggestions to improve mutual decision-making between the treating physician and the patients and their families as well as a number of new strategies to enhance perioperative outcomes for patients undergoing elective and emergent repair. Areas of uncertainty are highlighted that would benefit from further investigation in addition to existing limitations in diagnostic tests, pharmacologic agents, intraoperative tools, and devices.

Initial and midterm results of the Bolton Relay Thoracic Aortic Endovascular Pivotal Trial.

OBJECTIVE: To report the initial and midterm results of the Bolton Relay Thoracic Stent Graft for the endovascular treatment of thoracic aortic lesions [thoracic endovascular aortic repair (TEVAR)]. METHODS: The Bolton Relay Thoracic Aortic Endovascular Pivotal Trial was a prospective, nonrandomized, multicenter, U.S. Investigational Device Exemption study conducted at 27 U.S. investigational sites. One hundred twenty TEVAR subjects were treated with the Relay device between January 2007 and May 2010, with 13 patients enrolled during the continued access phase through September 2012. TEVAR outcomes were compared with a prospectively and retrospectively enrolled surgical cohort consisting of 60 patients enrolled under similar inclusion/exclusion criteria. Follow-up examinations were prescribed at 1 month, 6 months, and yearly thereafter for 5 years. Major adverse events (MAEs) included stroke, paralysis/paraplegia, myocardial infarction, procedural bleeding, respiratory failure, renal failure, wound healing complications, and aneurysm-related mortality. RESULTS: Stent grafts were successfully delivered and deployed in 129 of 133 patients (97.0%). At 30 days, a lower rate of mortality was observed in the TEVAR arm (5.3% vs 10.0%; P = .230), and TEVAR was associated with a significantly lower rate of MAEs (20.3% vs 48.3%; P < .001), primarily driven by a lower frequency of respiratory failure in the cohort (5.5% vs 21.6%; P = .007) and procedural bleeding. Freedom from aneurysm-related mortality through 5 years was similar at 91.3% for the TEVAR cohort and 89.4% for the surgical cohort (P = .406); with 5-year freedom from all-cause mortality at 57.1% and 50.2% (P = .289), respectively. Freedom from MAEs through 5 years was significantly higher in the TEVAR cohort (65.7% vs 44.7%; P = .001). Six TEVAR patients (4.5%) experienced core laboratory-reported type I or III endoleaks, and secondary procedures were performed in 10 patients (7.5%), with seven procedures to correct endoleak and one surgical conversion. Endograft migration occurred in three patients (2.3%) and wireform fractures were assessed in two patients (1.5%). Aneurysm sac size decreased or remained stable in 113 patients (85.0%) over 5-year follow-up. There were no instances of rupture or endograft occlusion. A 38-subject subset treated with the newer Relay Plus Delivery System had a significantly reduced MAE rate (15.8% vs 35.8%; P = .035), and fewer perioperative strokes (2.6% vs 12.6%; P = .108). CONCLUSIONS: Data from the Relay TEVAR clinical trial demonstrate safety and effectiveness of the Relay device compared with surgical controls, indicating continued device durability with a low rate of device-related complications through 5 years.

Endovascular repair with chimney technique of abdominal aortic aneurysm with hostile aortic neck.

Abdominal aortic aneurysm (AAA) with hostile aortic neck is not a good candidate for conventional endovascular aneurysm repair (EVAR), and a recent paper showed that EVAR with chimney technique (Ch-EVAR) yielded reasonable outcome. We report here a case of successful Ch-EVAR treatment of AAA with hostile neck. An 81-year-old man presented with a 71-mm AAA during evaluation of a gastric ulcer. Aortic neck was 30 mm in diameter, 10-15 mm in length and angulated by 100°. EVAR was performed with chimney stenting to both renal arteries, and the patient recovered after transient hematuria. At one-year follow-up, AAA had increased by 7 mm with delayed type I endoleak control without renal insufficiency. The patient needed close follow-up.

Late outcomes of a single-center experience of 400 consecutive thoracic endovascular aortic repairs.

BACKGROUND: In this study, we report the late outcomes of a large, decade-long single-center thoracic endovascular aortic repair experience. METHODS AND RESULTS: A prospectively maintained registry and the electronic medical records of 400 consecutive thoracic endovascular aortic repair performed at a tertiary care center were reviewed. The distribution of pathologies treated included aneurysms (198, 49%), dissections (100, 25%), penetrating ulcers (54, 14%), traumatic transections (25, 6%), and other pathologies (23, 6%). Spinal drains were placed prophylactically in 127 cases (32%) of planned extended aortic coverage. There were no acute surgical conversions. Adjunctive surgical procedures were performed on 94 patients (24%). Subclavian revascularizations were performed selectively in only 15% of zone 0 to 2 deployments. The median length of stay was 5 days (limits, 1 and 79 days). Overall 30-day mortality was 6.5% (elective, 2.6%; urgent, 9.5%; and emergent, 20%). Permanent spinal cord ischemia occurred in 4.5% and stroke in 3%. Kaplan-Meier estimates of survival were 82%, 76%, 68%, and 60% and freedom from secondary intervention was 90%, 86%, 81%, and 78% at 6, 12, 24, and 36 months, respectively. Risk factors for mortality included stroke, urgent/emergent repair, age ≥80 years, general anesthesia, and dissection pathology. CONCLUSIONS: Thoracic endovascular aortic repair may be used to treat a variety of thoracic aortic pathologies with a very low risk of intraoperative conversion. Overall rates of mortality and neurological complications were relatively low but significantly increased in emergent repairs. There appeared to be a substantial number of late deaths, which may represent a combination of poor patient selection and treatment failures.

Pivotal results for the Medtronic Valiant Thoracic Stent Graft System in the VALOR II trial.

OBJECTIVE: We report 30-day and 12-month results of endovascular treatment with the Valiant Thoracic Stent Graft System (Medtronic Vascular, Santa Rosa, Calif) in patients with descending thoracic aortic aneurysms of degenerative etiology. The Valiant stent graft is an evolution of the Talent thoracic stent graft (Medtronic Vascular). METHODS: The VALOR II (Evaluation of the Clinical Performance of the Valiant Thoracic Stent Graft System in the Treatment of Descending Thoracic Aneurysms of Degenerative Etiology in Subjects Who Are Candidates for Endovascular Repair) was a prospective, nonrandomized, pivotal trial conducted at 24 U.S. sites with enrollment between December 2006 and September 2009. Standard follow-up examinations, including physical examination, computed tomography, and chest radiography, were at 1, 6, and 12 months, and annually through 5 years. VALOR II outcomes were compared with those from the pivotal VALOR (Evaluation of the Medtronic Vascular Talent Thoracic Stent Graft System for the Treatment of Thoracic Aortic Aneurysms) trial of the Talent stent graft, which enrolled 195 patients with similar enrollment criteria. RESULTS: VALOR II enrolled 160 patients. Compared with VALOR patients, VALOR II patients had similar age and sex distribution but higher rates of cardiovascular risk factors and significantly more severe modified Society for Vascular Surgery/American Association for Vascular Surgery risk scores. Stent graft delivery and deployment were successful in 154 patients (96.3%). Outcomes at 30 days in VALOR II were perioperative mortality, 3.1%; major adverse events, 38.1%; paraplegia, 0.6%; paraparesis, 1.9%; and stroke, 2.5%. At 12 months, after the minimum sample size was reached, 151 patients were evaluated: aneurysm-related mortality was 4.0%, stent graft migration was 2.9%, and endoleak was 13.0%. Through 12 months, there were no ruptures, conversions to open surgery, secondary procedures due to endoleak >30 days, or loss of stent graft patency. The Valiant stent graft was statistically noninferior to the Talent stent graft in 12-month all-cause mortality (12.6% vs 16.1%) and exceeded the primary effectiveness goal of 12-month successful aneurysm treatment, defined as absence of aneurysm growth >5 mm and of secondary procedures for type I/III endoleak (97.4% vs 80.0%). CONCLUSIONS: The VALOR II 12-month results demonstrate that the Medtronic Valiant thoracic stent graft is a safe and effective treatment for patients with descending thoracic aortic aneurysms of degenerative etiology.

Results with the Talent thoracic stent graft in the VALOR trial.

OBJECTIVE: We report the 5-year outcomes of thoracic endovascular aneurysm repair (TEVAR) using the Medtronic Vascular Talent Thoracic Stent Graft System (Medtronic Vascular, Santa Rosa, Calif) in patients considered low or moderate risk for open surgical repair. METHODS: The Evaluation of the Medtronic Vascular Talent Thoracic Stent Graft System for the Treatment of Thoracic Aortic Aneurysms (VALOR) trial was a prospective, nonrandomized, multicenter, pivotal study conducted at 38 U.S. sites. Between December 2003 and June 2005, VALOR enrolled 195 patients who were low or moderate risk (0, 1, and 2) per the modified Society for Vascular Surgery and American Association for Vascular Surgery criteria. The patients had fusiform thoracic aortic aneurysms (TAAs) and/or focal saccular TAAs/penetrating atherosclerotic ulcers. Standard follow-up interval examinations were conducted at 1 month, 6 months, 1 year, and annually thereafter. RESULTS: Over the 5-year follow-up, 76 deaths occurred (43.9%). Freedom from all-cause mortality was 83.9% at 1 year and 58.5% at 5 years. Most deaths were due to cardiac, pulmonary or cancer-related causes. Freedom from aneurysm-related mortality (ARM) was 96.9% at 1 year and 96.1% at 5 years. There was only 1 case of ARM after the first year of follow-up. Over the 5-year follow-up period, four patients were converted to open surgery and four patients experienced aneurysm rupture. The 5-year freedom from aneurysm rupture was 97.1% and the 5-year freedom from conversion to surgery was 97.1%. The incidence of stent graft migration (>10 mm) was ≤ 1.8% in each year of follow-up. The rate of type I endoleak was 4.6% at 1 month, 6.3% from 1 month to 1 year, and 3.8% during year 5. The rate of type III endoleak was 1.3% at 1 month, 1.9% from 1 month to 1 year, and 1.9% during year 5. Through 5 years, 28 patients (14.4%) underwent 31 additional endovascular procedures on the original target lesion. The 5-year freedom from secondary endovascular procedures was 81.5%. CONCLUSIONS: Through 5-year follow-up in patients who were candidates for open surgical repair, TEVAR using the Talent Thoracic Stent Graft System has demonstrated sustained protection from ARM, aneurysm rupture, and conversion to surgery, and durable stent graft performance. Close patient follow-up remains essential after TEVAR.

Endovascular treatment of acute and chronic aortic pathology in patients with Marfan syndrome.

BACKGROUND: In patients with Marfan syndrome, the complications of aortic degeneration, including dissection, aneurysm, and rupture represent the main cause of mortality. Although contemporary management of ascending aortic disease requires open surgical reconstruction, endovascular repair is now available for management of descending thoracic and abdominal aortic pathology (ie, thoracic endovascular aortic repair [TEVAR], endovascular aneurysm repair [EVAR]). The short- and long-term benefit of endovascular repair in Marfan patients remains largely unproven. We examine our outcomes after EVAR in this patient population. METHODS: All patients with a diagnosis of Marfan syndrome who were treated with TEVAR/EVAR were evaluated in a retrospective review. Perioperative, procedure-specific and patient covariate data were aggregated. Primary endpoints were overall mortality and procedural success as divided into three categories: (1) successful therapy, (2) primary failure, or (3) secondary failure. RESULTS: Between 2000 and June 2010, 16 patients were identified as having undergone 19 TEVAR/EVAR procedures. These included three emergent operations (two for acute dissection/malperfusion and one for anastomotic disruption early after open repair). All 16 patients had previously undergone at least one (range, 1-5) open operation of the ascending aorta or arch at a time interval from 33 years to 1 week prior to the index endovascular repair. During a median follow-up of 9.3 months (range, 0-46 months), there were four deaths (25%). Six patients (38%) had successful endovascular interventions. Despite early success, there was one death in this group at 1 month postintervention. Seven patients (44%) experienced primary treatment failure with five undergoing open conversion and one undergoing left subclavian coil embolization (the seventh was lost to follow-up and presented 4 months later in cardiac arrest and expired without repair). There were three deaths in the primary treatment failure group. Two patients experienced secondary treatment failure. One underwent the index TEVAR for acute dissection with malperfusion and required a subsequent TEVAR for more distal aortic pathology. He is stable without disease progression. The other patient underwent open conversion after a second EVAR with four-vessel "chimney" stent grafts and is stable with his entire native aorta having been replaced. CONCLUSIONS: Aortic disease associated with Marfan syndrome is a complex clinical problem and many patients require remedial procedures. Endovascular therapy can provide a useful adjunct or bridge to open surgical treatment in selected patients. However, failure of endovascular therapy is common, and its use should be judicious with close follow-up to avoid delay if open surgical repair is required.

Duodenocaval Fistula from an Inferior Vena Cava Filter Perforation.

Background: This article describes a rare case of inferior vena cava (IVC) filter perforation into the duodenum in a patient presenting with abdominal pain. Case report: A 55 year old woman presented with abdominal pain four years after an IVC filter placement. Workup demonstrated an IVC filter strut perforating the duodenum. The filter was removed via laparotomy, the duodenum was closed primarily, and the IVC was repaired. The patient was discharged home on post-operative day five and is doing well. Conclusions: Most extraluminal perforations of IVC filter struts are asymptomatic. Rare filter associated duodenal perforations may present with non-specific abdominal symptoms. If no other diagnosis can be attributed to the patient's presentation, direct removal of the filter and repair of the duodenum are indicated.

Outcomes of endovascular repair of ruptured descending thoracic aortic aneurysms.

BACKGROUND: Thoracic endovascular aortic repair offers a less invasive approach for the treatment of ruptured descending thoracic aortic aneurysms (rDTAA). Due to the low incidence of this life-threatening condition, little is known about the outcomes of endovascular repair of rDTAA and the factors that affect these outcomes. METHODS AND RESULTS: We retrospectively investigated the outcomes of 87 patients who underwent thoracic endovascular aortic repair for rDTAA at 7 referral centers between 2002 and 2009. The mean age was 69.8+/-12 years and 69.0% of the patients were men. Hypovolemic shock was present in 21.8% of patients, and 40.2% were hemodynamically unstable. The 30-day mortality rate was 18.4%, and hypovolemic shock (odds ratio 4.75; 95% confidence interval, 1.37 to 16.5; P=0.014) and hemothorax at admission (odds ratio 6.65; 95% confidence interval, 1.64 to 27.1; P=0.008) were associated with increased 30-day mortality after adjusting for age. Stroke and paraplegia occurred each in 8.0%, and endoleak was diagnosed in 18.4% of patients within the first 30 days after thoracic endovascular aortic repair. Four additional patients died as a result of procedure-related complications during a median follow-up of 13 months; the estimated aneurysm-related mortality at 4 years was 25.4%. CONCLUSIONS: Endovascular repair of rDTAA is associated with encouraging results. The endovascular approach was associated with considerable rates of neurological complications and procedure-related complications such as endoleak.

Hybrid management of proximal right subclavian artery aneurysms.

Surgical repair of proximal right subclavian artery aneurysms can be difficult. They typically require a combined mediastinal exposure to control the innominate and right common carotid arteries and a supra- or infraclavicular exposure for distal control, with either a segmental resection and bypass or a bifurcated reconstruction. In this report, we present four cases utilizing a single-stage, hybrid technique combining an endovascular stent graft and an extra-anatomical bypass to repair proximal right subclavian artery aneurysms without the need for mediastinal exposure or extensive surgical reconstruction. There were no deaths and two minor neurologic events.

The advent of thoracic endovascular aortic repair is associated with broadened treatment eligibility and decreased overall mortality in traumatic thoracic aortic injury.

BACKGROUND: Aortic injury is the second leading cause of death in trauma. Thoracic endovascular aortic repair (TEVAR) has recently been applied to traumatic thoracic aortic injuries (TTAIs) as a minimally invasive alternative to open surgery. We sought to determine the impact of TEVAR on national trends in the management of TTAI. METHODS: We queried the Nationwide Inpatient Sample from the years 2001 to 2007 to select patients diagnosed with TTAI (International Classification of Disease-9 code 901.0). Patients were evaluated based on open surgical repair, TEVAR, or nonoperative management, before and after widespread adoption of TEVAR (2001-2005 and 2006-2007). Outcomes of interest were inpatient mortality, length of stay (LOS), and major complications. RESULTS: An estimated 1180 annual admissions occurred for TTAI in the United States. Comparing the two time periods, there was an increase in TEVAR (P < .001) with a simultaneous decrease in open repair (P < .001) in 2006 to 2007. The overall number of interventions also increased (P < .001). Overall mortality decreased (25.0% vs 19.0%;P < .001), corresponding to improved survival in the nonoperative group (28.0% vs 23.2%; P < .001). There was no improvement in open repair mortality rates between the two time periods. Comparing intervention types, the TEVAR group had a higher percentage of patients with brain injury (26.1% vs 20.6%; P = .008), lung injury (25.0% vs 17.7%; P < .001), and hemothorax (32.5% vs 21.7%; P < .001) than the open surgery group. There were no differences in the number of intra-abdominal injuries or major orthopedic fractures. The open surgery group had more respiratory complications (43.9% vs 54.2%; P < .001), whereas TEVAR had a higher stroke rate (1.9% vs 0.7%; P = .021). There were no differences in paraplegia or renal failure. Overall in-hospital mortality was 23.2% (nonoperative group 26.7%, open repair 12.4%, and TEVAR 10.6%). Mortality between open repair and TEVAR groups were not significantly different. LOS was shorter among the TEVAR group vs open (15.7 vs 22.9 days; P < .001). CONCLUSION: TEVAR has replaced open repair as the primary operative treatment for TTAI and has extended operative treatment to those patients not previously considered candidates for repair. Increased utilization of TEVAR is associated with improved overall mortality. There is no difference in mortality between TEVAR and open repair groups in our study, which likely reflects the multisystem nature of injury and greater preoperative risk in the TEVAR group.

Endovascular chimney technique versus open repair of juxtarenal and suprarenal aneurysms.

OBJECTIVE: To compare early outcomes of endovascular repair of juxtarenal and suprarenal aneurysms using the chimney technique with open repair in anatomically-matched patients. METHODS: Between January 2008 and December 2009, 21 patients underwent endovascular repair of juxtarenal and suprarenal aortic aneurysms with chimney stenting (Ch-EVAR) of 1 or 2 renal and/or superior mesenteric artery (SMA) vessels. These were compared with 21 anatomically-matched patients that underwent open repair (OR) during the same time period. Primary end points were 30-day mortality, chimney stent patency, and type Ia endoleak. Secondary end points included early complications, renal function, blood loss, and length of stay (LOS). RESULTS: Despite a higher proportion of women, oxygen-dependent pulmonary disease and lower baseline renal function, 30-day mortality was identical with one death (4.8%) in each group. Blood loss and total LOS were significantly less for Ch-EVAR. Six patients (29%) in the chimney group had acute kidney injury (AKI) compared with the open group, in which there were one (4.8%) AKI and four (19%) acute renal failures, of which two (9.5%) required chronic hemodialysis. Renal function at 12 months demonstrated similar declines in the overall estimated glomerular filtration rate (eGFR) in the Ch-EVAR and OR groups (11.1 ± 19.6 vs 10.4 ± 25.2, P = NS, respectively). There was one asymptomatic SMA stent occlusion at 6 months and partial compression of a second SMA stent which underwent repeat balloon angioplasty. Primary patency at 6 and 12 months was 94% and 84%, respectively. There was one type Ia endoleak noted at 30 days which resolved by 6 months. CONCLUSIONS: Ch-EVAR may extend the anatomical eligibility of endovascular aneurysm repair using conventional devices. It appears to have similar mortality to open repair with less morbidity. Long-term durability and stent patency remain to be determined.

Comparative effectiveness of the treatments for thoracic aortic transection [corrected].

OBJECTIVES: To synthesize the available evidence regarding the outcomes associated with nonoperative management, open repair, and endovascular repair of thoracic aortic transection. METHODS: We searched electronic databases (MEDLINE, EMBASE Cochrane, Web of Science, and Scopus) for studies that enrolled patients with aortic transection and measured the outcomes of interest. Two reviewers determined study eligibility and extracted data. We estimated the event rate associated with the different approaches from case series and the relative risk from comparative studies. Estimates from each study were pooled using the random effects model. RESULTS: We found 139 studies that fulfilled the inclusion criteria, the majority of which were noncomparative surgical case series, retrospective, and none were randomized. Studies included 7768 patients, the majority of which were males. The mortality rate was significantly lower in patients who underwent endovascular repair, followed by open repair and nonoperative management (9%, 19%, and 46%, respectively, P < .01). No significant difference in event rate across the three groups was noted for the outcomes of anterior stroke, posterior stroke, or any stroke. The risk of spinal cord ischemia and end-stage renal disease were higher in open repair compared with the other 2 groups (9% vs 3% and 3%, P = .01 for spinal cord ischemia and 8% vs 5% and 3%, P = .01 for end-stage renal disease). Compared with endovascular repair, open repair was associated with an increased risk of graft infection and systemic infections. Meta-analyses of comparative studies demonstrated that compared with open repair, endovascular repair is associated with reduced mortality and spinal cord ischemia (relative risk, 0.61; 95% confidence interval, 0.46-0.80; and relative risk, 0.34; 95% confidence interval, 0.16-0.74; respectively). Inferences are limited by methodological quality, survival, and publication biases. CONCLUSIONS: Very low-quality evidence suggests that, compared with open repair or nonoperative management, endovascular repair of thoracic aortic transection is associated with better survival and decreased risk of spinal cord ischemia, renal injury, and graft and systemic infections. Nonoperative management is associated with the least favorable outcomes.