The Society for Vascular Surgery® pursued development of clinical practice guidelines for the management of traumatic thoracic aortic injuries with thoracic endovascular aortic repair. In formulating ...clinical practice guidelines, the Society selected a panel of experts and conducted a systematic review and meta-analysis of the literature. They used the Grading of Recommendations Assessment, Development and Evaluation methods (GRADE) to develop and present their recommendations. The systematic review included 7768 patients from 139 studies. 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). Based on the overall very low quality of evidence, the committee suggests that endovascular repair of thoracic aortic transection is associated with better survival and decreased risk of spinal cord ischemia, renal injury, graft, and systemic infections compared with open repair or nonoperative management (Grade 2, Level C). The committee was also surveyed on a variety of issues that were not specifically addressed by the meta-analysis. On these select matters, the majority opinions of the committee suggest urgent repair following stabilization of other injuries, observation of minimal aortic defects, selective (vs routine) revascularization in cases of left subclavian artery coverage, and that spinal drainage is not routinely required in these cases.
The Society for Vascular Surgery pursued development of clinical practice guidelines for the management of the left subclavian artery with thoracic endovascular aortic repair (TEVAR). In formulating ...clinical practice guidelines, the society selected a panel of experts and conducted a systematic review and meta-analysis of the literature. They used the grading of recommendations assessment, development, and evaluation (GRADE) method to develop and present their recommendations. The overall quality of evidence was very low. The committee issued three recommendations. Recommendation 1: In patients who need elective TEVAR where achievement of a proximal seal necessitates coverage of the left subclavian artery, we suggest routine preoperative revascularization, despite the very low-quality evidence (GRADE 2, level C). Recommendation 2: In selected patients who have an anatomy that compromises perfusion to critical organs, routine preoperative LSA revascularization is strongly recommended, despite the very low-quality evidence (GRADE 1, level C). Recommendation 3: In patients who need urgent TEVAR for life-threatening acute aortic syndromes where achievement of a proximal seal necessitates coverage of the left subclavian artery, we suggest that revascularization should be individualized and addressed expectantly on the basis of anatomy, urgency, and availability of surgical expertise (GRADE 2, level C).
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.
Background Acute type B aortic dissection complicated by malperfusion or rupture carries a risk of death. We report 30-day and 12-month results of endovascular treatment with the Valiant Captivia ...Thoracic Stent Graft (Medtronic, Santa Rosa, CA) in patients with acute, complicated type B aortic dissection. Methods The Medtronic DISSECTION Trial is a prospective, nonrandomized, United States Food and Drug Administration-regulated, pivotal trial that enrolled patients at 16 United States sites between June 2010 and May 2012. Follow-up examinations were at 1, 6, and 12 months, and annually through 5 years. Results Fifty patients were enrolled. Mean age was 57 years (range, 18 to 83 years). Rupture was present in 20% and malperfusion in 86%. Mean time from symptom onset to procedure was 4.7 days (range, 0 to 23 days). Successful deployment and coverage of the primary entry tear was achieved in all patients. Two patients (4%) underwent open repair 5 and 56 days postprocedure for retrograde aortic dissections. Thirty-day mortality was 8% (4 of 50) and 12-month mortality was 15% (7 of 48). Spinal ischemia was 6%. Serious adverse events occurred in 23 of 49 patients within 12 months. Four patients underwent secondary endovascular procedures. Through 12 months, true lumen diameter in the stented region remained stable or increased in 93.1% (27 of 29) of patients. False lumen diameter remained stable or decreased in 22 patients and was partially or completely thrombosed in 91% (30 of 33). Conclusions The initial results of the Valiant Thoracic Stent Graft in the treatment of acute type B aortic dissection are encouraging, but longer-term outcomes are needed.
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.
Background Our primary objective was to demonstrate the utility and feasibility of the intraoperative assessment of colon and rectal perfusion using fluorescence angiography (FA) during left-sided ...colectomy and anterior resection. Anastomotic leak (AL) after colorectal resection increases morbidity, mortality, and, in cancer cases, recurrence rates. Inadequate perfusion may contribute to AL. The PINPOINT Endoscopic Fluorescence Imaging System allows for intraoperative assessment of anastomotic perfusion. Study Design This is a prospective, multicenter, open-label, clinical trial that assessed the feasibility and utility of FA for intraoperative perfusion assessment during left-sided colectomy and anterior resection at 11 centers in the United States. Results A total of 147 patients were enrolled, of whom 139 were eligible for analysis. Diverticulitis (44%), rectal cancer (25%), and colon cancer (21%) were the most prevalent indications for surgery. The mean level of anastomosis was 10 ± 4 cm from the anal verge. Splenic-flexure mobilization was performed in 81% and high ligation of the inferior mesenteric artery in 61.9% of patients. There was a 99% success rate for FA, and FA changed surgical plans in 11 (8%) patients, with the majority of changes occurring at the time of transection of the proximal margin (7%). Overall morbidity rates were 17%. The anastomotic leak rate was 1.4% (n = 2). There were no anastomotic leaks in the 11 patients who had a change in surgical plan based on intraoperative perfusion assessment with FA. Conclusions PINPOINT is a safe and feasible tool for intraoperative assessment of tissue perfusion during colorectal resection. There were no anastomotic leaks in patients in whom the anastomosis was revised based on inadequate perfusion with FA.
Background Ruptured descending thoracic aortic aneurysm (rDTAA) is a cardiovascular catastrophe, associated with high morbidity and mortality, which can be managed either by open surgery or thoracic ...endovascular aortic repair (TEVAR). The purpose of this study is to retrospectively compare the mortality, stroke, and paraplegia rates after open surgery and TEVAR for the management of rDTAA. Methods Patients with rDTAA treated with TEVAR or open surgery between 1995 and 2010 at seven institutions were identified and included for analysis. The outcomes between both treatment groups were compared; the primary end point of the study was a composite end point of death, permanent paraplegia, and/or stroke within 30 days after the intervention. Multivariate logistic regression analysis was used to identify risk factors for the primary end point. Results A total of 161 patients with rDTAA were included, of which 92 were treated with TEVAR and 69 with open surgery. The composite outcome of death, stroke, or permanent paraplegia occurred in 36.2% of the open repair group, compared with 21.7% of the TEVAR group (odds ratio OR, 0.49; 95% confidence interval CI, .24-.97; P = .044). The 30-day mortality was 24.6% after open surgery compared with 17.4% after TEVAR (OR, 0.64; 95% CI, .30-1.39; P = .260). Risk factors for the composite end point of death, permanent paraplegia, and/or stroke in multivariate analysis were increasing age (OR, 1.04; 95% CI, 1.01-1.08; P = .036) and hypovolemic shock (OR, 2.47; 95% CI, 1.09-5.60; P = .030), while TEVAR was associated with a significantly lower risk of the composite end point (OR, 0.44; 95% CI, .20-.95; P = .039). The aneurysm-related survival of patients treated with open repair was 64.3% at 4 years, compared with 75.2% for patients treated with TEVAR ( P = .191). Conclusions Endovascular repair of rDTAA is associated with a lower risk of a composite of death, stroke, and paraplegia, compared with traditional open surgery. In rDTAA patients, endovascular management appears the preferred treatment when this method is feasible.
Objective Thoracic endovascular aortic repair (TEVAR) is applicable to a spectrum of thoracic aortic pathology with half of the procedures performed world-wide for indications other than degenerative ...aneurysm of the descending thoracic aorta (DTA). This multicenter, prospective study queried perioperative and one-year results of TEVAR using the commercially available GORE TAG device, in the treatment of acute complicated Type B dissection (cTBD), traumatic aortic tear (TT), and ruptured degenerative aneurysm (RDA) of the DTA. Methods This prospective, non-randomized, literature controlled study included 59 patients; cTBD, n = 19; RDA, n = 20; TT, n = 20. The primary end-point was the composite of death and total paraplegia in subjects at ≤ 30 days post-treatment compared with a cohort from current literature. Secondary end-points included adverse events related to device, procedural and systemic complications, and one-year survival. Results All 59 patients had successful endoprosthesis deployment. Fifteen of 19 (79%) patients in the cTBD group had either rupture or malperfusion syndromes at presentation. Combined 30-day mortality/paraplegia rate was 13.6% (8/59), with seven (11.9%) deaths (cTBD 3, RDA 3 and TT 1) and 1 (TT, 1.7%) case of paraplegia. The primary end-point for the TEVAR cohort was significantly lower ( P = .008) when compared with a composite literature control of 800 patients (combined 30-day mortality/paraplegia of 29.6%). Thirty-day complications of any nature occurred in 48 (81%) patients; 11 (18.6%) were device related, and 43 (73%) experienced one or more systemic adverse events. Six (10%) patients required additional TEVAR implantations and 3 (5%) patients (one in each pathology group) required conversion to open surgery. Seventeen (29%) patients had endoleaks of any kind or degree through 30 days; cTBD (7), TT (2), RDA (8). Nine patients (15.3%) had perioperative strokes with two resultant deaths. During mean follow-up time of 409 ± 309 days, an additional 12 patients died, one patient required open conversion (cTBD), and two patients had major device related events. Actuarial survival at one year was 66% (range, 52%-77%) for the entire cohort; (cTBD) 79% (range, 53%-92%), (TT) 79% (range, 53%-92%) and (RDA) 37% (range, 16%-59%). On regression analysis, age at treatment (1.05 range, 1.01-1.09; P = .008) and chronic obstructive pulmonary disease (COPD) (4.3 range, 1.3-14.4; P = .02) were predictive of death at one year. Conclusion This study confirmed treatment advantages for TEVAR for thoracic aortic catastrophes when compared with literature-based results of open repair. One-year treatment results indicate a low incidence of graft-related complications. TEVAR is the preferred initial treatment for the DTA catastrophes studied herein.
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.
Background Risk factors for spinal cord ischemia (SCI) after thoracic endovascular aneurysm repair (TEVAR) remain unclear. Aortic coverage was examined as a risk factor for SCI using quantitative ...three-dimensional computed tomography angiography (CTA) analysis. Methods The medical records, radiographic imaging studies, and a prospectively maintained database of all TEVAR procedures performed during a 7-year period were retrospectively reviewed. Preoperative anatomic dimensions and postoperative graft path lengths were measured from CTAs using curved planar and orthogonal multiplanar reformations along centerline paths. SCI was defined as transient or permanent lower extremity neurologic deficit without associated intracerebral hemispheric events. Results Of 326 TEVAR cases, 241 patients (74%) had satisfactory imaging. Thirty-three (10%) had SCI. These patients were older (72.7 ± 10.6 vs 64.7 ± 15.8 years, p = 0.005) and had longer intraoperative procedure times (137 ± 65 vs 113 ± 68 minutes, p = 0.05). Despite similar total lengths of native thoracic aorta (295.0 ± 36.3 vs 283.1 ± 39.8 mm, p = 0.17), patients with permanent SCI had a greater absolute (260.5 ± 40.9 vs 195.8 ± 81.6 mm, p = 0.002) and proportionate (88.8% ± 12.1% vs 67.6% ± 24.0%, p = 0.001) length of aortic coverage. The average length of uncovered aorta proximal to the celiac artery in patients with SCI was 17.3 ± 21.8 mm vs 63.1 ± 62.9 mm in patients without SCI ( p = 0.0006). Neither the patency of the hypogastric arteries nor left subclavian artery was associated with SCI. Conclusions The extent and distal location (relative to the celiac artery) of aortic coverage were associated with an increased risk of SCI. Prophylactic measures for spinal cord protection should be considered in patients whose thoracic aortas require extensive coverage.
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