Spinal cord ischemia and reinterventions following thoracic endovascular repair for acute type B aortic dissections.

OBJECTIVE: The technical aspects of thoracic endovascular aortic repair (TEVAR) for acute type B aortic dissection (TBAD), specifically the location of proximal seal zone (PSZ) (need to cover the left subclavian artery [LSA]), distal seal zone (DSZ) (length of aortic coverage), benefit of LSA revascularization, and prophylactic lumbar drainage are still debated. Each of these issues has potential benefits but also has known risks. This study aims to identify factors associated with reintervention and spinal cord ischemia (SCI) following TEVAR for acute TBAD with a zone 3 entry tear. METHODS: The Vascular Quality Initiative was queried for TEVARs performed for acute TBAD with zone 3 entry tear, zone 3 proximal zone of disease, treated with TEVAR extending between zone 2 and zone 5. The primary outcomes were SCI and related reintervention. Secondary outcomes were stroke, arm ischemia, and retrograde type A dissection (RTAD). The exposure variables were PSZ 2 vs 3, DSZ 4 vs 5, prophylactic lumbar drain, and LSA revascularization. Univariate analyses were conducted with χ2 analysis, and multivariable logistic regression was used to evaluate association with outcomes. RESULTS: Of 583 patients who met inclusion criteria, 266 had PSZ 2 and 317 had PSZ 3. On univariate analysis, PSZ 2 was associated with a higher rate of reintervention, but PSZ2 was not significant on multivariable analysis after accounting for age, sex, race, smoking, PSZ, DSZ, prophylactic lumbar drain, and LSA patency. PSZ 2 was not associated with SCI, arm ischemia, or RTAD. PSZ 2 was associated with a trend towards a higher rate of stroke. DSZ 4 and DSZ 5 were performed in 161 and 422 TEVARs, respectively, and DSZ 5 was associated with a higher rate of SCI on univariate (3 [1.9%] vs 39 [9.2%]; P = .01) and multivariable (odds ratio, 7.384; 95% confidence interval, 2.193-24.867; P = .001) analyses. Prophylactic lumbar drain placement was not statistically significantly associated with SCI, but lack of postoperative LSA patency was associated with SCI (odds ratio, 2.966; 95% confidence interval, 1.016-8.656; P = .05). CONCLUSIONS: This study found that PSZ 2 was not associated with lower reinterventions or higher rates of SCI but trended towards a higher rate of stroke than PSZ 3. Additionally, DSZ 5 was strongly associated with SCI when compared with DSZ 4, highlighting the importance of limiting aortic coverage to coverage of the proximal entry tear when possible.

Prospective assessment of dynamic changes in frailty and its impact on early clinical outcomes following physician-modified fenestrated-branched endovascular repair of complex abdominal and thoracoabdominal aortic aneurysms.

INTRODUCTION: Frailty, a predictor of poor outcomes, has been widely studied as a screening tool in surgical decision-making. However, the impact of frailty on the outcomes after fenestrated-branched endovascular aortic repairs (FBEVARs) is less well established. In addition, the changes in frailty during recovery after FBEVAR are unknown. We aim to assess the impact of frailty on outcomes of high-risk patients undergoing physician-modified FBEVARs for complex abdominal and thoracoabdominal aortic aneurysms, as well as the changes in frailty during follow-up. METHODS: Consecutive patients enrolled in a single-center prospective Physician-Sponsored Investigational Device Exemption protocol (FDA# G200159) were evaluated. In addition to the baseline characteristics, frailty was assessed using the Hopkins Frailty Score (HFS) and frailty index (FI) measured by the Frailty Meter. Sarcopenia was measured by L3 total psoas muscle area (PMA). These measurements were repeated during follow-up. The follow-up HFS and FI were compared with baseline scores using the Wilcoxon signed-rank test, whereas follow-up PMA measurements were compared with the baseline using the paired t test. The association between baseline frailty and morbidity was evaluated by the Wilcoxon rank-sum test. RESULTS: Seventy patients were analyzed in a prospective Physician-Sponsored Investigational Device Exemption study from February 9, 2021, to June 2, 2023. At baseline, HFS identified 54% of patients as not frail, 43% as intermediately frail, and 3% as frail. Technical success of FBEVAR was 94% with one in-hospital mortality. Early major adverse events were seen in 10 (14.3%) patients. No difference in baseline FI was seen between patients with early morbidity and those without. Patients who were not frail per HFS were less likely to experience early morbidity (P = .033), and there was a significantly lower baseline PMA in patients who experienced early morbidity (P = .016). At 1 month, patients experienced a significant increase in HFS and HFS category (P = .001 and P = .01) and a significant decrease in sarcopenia (mean PMA: -96 mm2, P = .005). At 6 months, HFS and HFS category as well as PMA returned toward baseline (P = .42, P = .38, and mean PMA: +4 mm2, P = .6). CONCLUSIONS: Preoperative frailty and sarcopenia were associated with early morbidity after physician-modified FBEVAR. During follow-up, patients became more frail and sarcopenic by 1 month. Recovery from this initial decline was seen by 6 months, suggesting that frailty and sarcopenia are reversible processes rather than a unidirectional phenomenon of continued decline.

Early outcomes from the pivotal trial of a four-branch off-the shelf solution to treat complex abdominal and type IV thoracoabdominal aortic aneurysms.

BACKGROUND: This study reports the 30-day outcomes of the primary arm of the GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis (TAMBE) pivotal trial for complex abdominal aortic aneurysm repair. METHODS: This multicenter, nonrandomized, prospective study of the TAMBE device included patients enrolled in the primary study arm of extent IV thoracoabdominal aortic aneurysms and pararenal aneurysms. Technical success and major adverse events were analyzed per the Society for Vascular Surgery guidelines. RESULTS: The 102 patients of the primary arm who underwent endovascular repair using the TAMBE device were a mean age of 73 ± 6.4 years (range, 58-82 years) and 84 (84.2%) were male. The mean body mass index was 28.3 ± 5.0 kg/m2. Fifty-nine patients (57.8%) were treated for extent IV and 43 (42.2%) pararenal aneurysms; the mean maximum diameter of the aneurysms was 59.4 ± 7.8 mm. A prophylactic cerebral spinal fluid drain was used in 10 patients (9.8%). Technical success was achieved in 99% of patients, with the single failure owing to unsuccessful cannulation of the left renal artery. Mean procedure time was 315 ± 103 minutes (range, 163-944 minutes), estimated blood loss was 300 ± 296 mL (range, 10-2000 mL), and contrast administration was 153.6 ± 73.5 mL (range, 16-420 mL). The intensive care unit length of stay was 58.7 ± 52.7 hours (range, 1-288 mL). In 28 patients (27.5%), a total of 32 additional endovascular components were deployed to manage procedural complications including aortic and target vessel dissections and injuries not related to access. Bridging stent grafts were deployed to incorporate 407 target vessels (mean 1.6/per vessel; range, 1-4). Postoperative transfusion was required in 14 patients (13.7%). Major adverse events occurred in seven patients (6.9%) through 30 days. Events included respiratory failure (n = 2), disabling stroke (n = 1), new-onset renal failure requiring dialysis (n = 2), and paraplegia (n = 2). At 30 days, there was one patient with intraoperative rupture; no severe bowel ischemia or lesion-related/all-cause mortality were reported. The Core lab-reported patency was 100% in the aortic component, superior mesenteric artery, and celiac artery, and 95.9% in the left renal and 99.0% in the right renal branch components through 30 days of follow-up. Reinterventions through 30 days were performed in 9 of 96 patients (9.4%) and were all minor. CONCLUSIONS: Early TAMBE device outcomes demonstrate a high technical success rate, no 30-day lesion-related mortality, and a low rate of safety events within 30 days of the index procedure.

The Initial Results of Physician-Modified Fenestrated-Branched Endovascular Repairs of the Aortic Arch and Lessons Learned From the First 21 Cases.

INTRODUCTION: Physician-modified fenestrated-branched endovascular aortic repair (PM-FBEVAR) for the aortic arch provides a minimally invasive treatment option for patients who are too high-risk for open repair. Improvements in technique are gained with ongoing experience with these complex repairs. This study aims to describe outcomes of arch PM-FBEVAR and technical lessons. MATERIALS AND METHODS: A retrospective review of consecutive patients who underwent PM-FBEVAR with zone 0 proximal sealing at a single institution between January 2019 and July 2023 was performed. Cases completed using initial techniques (early technique) were compared with cases using the current techniques (current technique). Modification technique changed to include a self-orienting spine trigger wire and anatomically specific fenestrations or inner branches in the current group. The primary outcome was in-hospital mortality. Secondary outcomes included technical success and 30 day stroke. RESULTS: A total of 21 patients underwent arch PM-FBEVAR, with 7 in the early group and 14 in the current group. Severe comorbidities were present in both groups including chronic obstructive pulmonary disease (COPD) (43% vs 36%), prior open ascending aortic repair (57% vs 43%), and prior stroke (86% vs 21%), respectively. Technical success was the same (86% vs 86%, p=1.0). Fluoroscopy time (56 vs 24 min, p=0.012) and in-hospital death (43% vs 0%, p=0.026) were significantly lower in the current group. A 30 day stroke rate (29% vs 7%, p=0.247) was non-significantly decreased in the current group. All-cause mortality was 100% vs 7% during median follow-up of 8 and 6 months (p<0.001). Three deaths in the early group were related to their aortic arch repair including aortic rupture during endograft advancement and 2 postoperative strokes. CONCLUSION: There is a significant learning curve associated with aortic arch PM-FBEVAR. This study suggests that gained experience, use of the spine trigger wire technique, and precise creation of fenestrations or inner branches can lead to a shorter procedure time and lower complications. CLINICAL IMPACT: Physician modified fenestrated branched endografting is feasible for the aortic arch. The high rate of stroke and perioperative mortality was reduced with incorporation of self-orienting spine trigger wire and anatomically specific inner branch creation.

Readmission after early thoracic endovascular aortic repair versus medical management of acute type B aortic dissection.

BACKGROUND: The use of thoracic endovascular aortic repair (TEVAR) for the management of acute uncomplicated type B aortic dissection (TBAD) has increased. Although the results from early studies were promising, larger randomized trials evaluating TEVAR are lacking. It is also unclear where sufficient equipoise exists for such trials. In the present study, we evaluated the number of readmissions and unplanned operations after TEVAR vs those after medical management as the initial treatment of acute uncomplicated TBAD and the frequency of each treatment in this population. METHODS: We performed a multi-institutional retrospective review of patients with acute TBAD from 2015 to 2020 with the 1-year outcomes available, excluding patients with prior aortic intervention or chronic, iatrogenic or traumatic etiologies. The primary exposure was TEVAR vs medical management at the index admission. The patient demographics, clinical presentation, and imaging findings were analyzed using bivariate and multivariate logistic regression for the primary outcomes of unplanned readmission and/or operation after the initial admission. The secondary outcomes were mortality, myocardial infarction, stroke, renal failure requiring dialysis, retrograde type A dissection, and length of stay. We hypothesized that the readmissions would be higher with medical management. RESULTS: A total of 216 patients with TBAD (47 with complicated and 169 with uncomplicated) from two large academic centers were identified. Of the 169 patients with uncomplicated TBAD, 83 (49%) had been treated medically and 86 (51%) had undergone TEVAR at the initial admission. No differences were found in the demographics or high-risk imaging features at presentation. The medically managed patients had had higher rates of unplanned readmission (34% vs 9%; P = .0001) and operation (28% vs 8%; P = .0007) but shorter lengths of stay (6.3 vs 13.1 days; P < .0001). No differences were found in mortality, although the rate of myocardial infarction was higher in the medically managed group (10.8% vs 2.3%; P = .02). Although 28% of the medically managed patients had later required operation, they had had morbidity and mortality similar to those of patients who had undergone initial TEVAR. Initial medical management was associated with unplanned readmission (odds ratio, 8.3; P = .02) and the need for operation (odds ratio, 4.56; P = .006). No differences were found in the outcomes according to the involved aortic zones. CONCLUSIONS: In the present study, medical management of acute uncomplicated TBAD was associated with higher rates of readmission and the need for unplanned operation compared with TEVAR. However, no differences were found in the 1-year mortality for the patients for whom medical management had failed. Because one half of the patients had undergone medical management and one half had undergone early TEVAR, this finding suggests clinical equipoise for the treatment of acute uncomplicated TBAD. Therefore, a larger randomized trial appears warranted to determine whether a clear benefit exists for early TEVAR.

Comparative outcomes of physician-modified fenestrated-branched endovascular repair of post-dissection and degenerative complex abdominal or thoracoabdominal aortic aneurysms.

OBJECTIVE: Fenestrated-branched endovascular repair has become a favorable treatment strategy for patients with complex abdominal aortic aneurysms (cAAAs) and thoracoabdominal aortic aneurysms (TAAAs) who are high risk for open repair. Compared with degenerative aneurysms, post-dissection aneurysms can pose additional challenges for endovascular repair. Literature on physician-modified fenestrated-branched endovascular aortic repair (PM-FBEVAR) for post-dissection aortic aneurysms is sparse. Therefore, the aim of this study is to compare the clinical outcomes of patients who underwent PM-FBEVAR for degenerative and post-dissection cAAAs or TAAAs. METHODS: A single-center institutional database was retrospectively reviewed for patients that underwent PM-FBEVAR between 2015 and 2021. Infected aneurysms and pseudoaneurysms were excluded. Patient characteristics, intraoperative details, and clinical outcomes were compared between degenerative and post-dissection cAAAs or TAAAs. The primary outcome was 30-day mortality. The secondary outcomes included technical success, major complications, endoleak, target vessel instability, and reintervention. RESULTS: Of the 183 patients who underwent PM-FBEVAR in the study, 32 had aortic dissections, and 151 had degenerative aneurysms. There was one 30-day death (3.1%) in the post-dissection group and eight 30-day deaths (5.3%) in the degenerative aneurysm group (P = .99). Technical success, fluoroscopy time, and contrast usage were similar between the post-dissection and degenerative groups. Reintervention during follow-up (28% vs 35%; P = .54) and major complications were not statistically significantly different between the two groups. Endoleak was the most common reason for reintervention, with the post-dissection group having a higher rate of type IC, II, and IIIA endoleaks (31% vs 3%; P < .0001; 59% vs 26%; P = .0002; and 16% vs 4%; P = .03). During the mean follow-up of 14 months, all-cause mortality was similar between the groups (12.5% vs 21.9%; P = .23). CONCLUSIONS: PM-FBEVAR is a safe treatment for post-dissection cAAAs and TAAAs with high technical success. However, endoleaks requiring reintervention were more frequent in post-dissection patients. The impact of these reinterventions on long-term durability will be assessed with continued follow-up.

Aortobifemoral reconstruction in open abdominal aortic aneurysm repair is associated with increased morbidity and mortality.

OBJECTIVE: Much attention has been given to the influence of anatomic and technical factors, such as maximum abdominal aortic aneurysm diameter and proximal clamp position, in open abdominal aortic aneurysm repair (OSR). However, no studies have rigorously examined the correlation between site of distal anastomosis and OSR outcomes despite conventional wisdom that more proximal sites of anastomosis are preferrable when technically feasible. This study aimed to test the association between sites of distal anastomosis and clinical outcomes for patients undergoing primary elective OSR. METHODS: Our study included 5683 patients undergoing primary elective OSR at 233 centers from 2014 to 2020. Using a variety of statistical methods to account for potential confounders, including multivariable logistic regression and Cox proportional hazards modeling, as well as subgroup analysis, we examined the association between site of distal anastomosis and clinical outcomes in elective OSR. Primary outcomes were major in-hospital complication rate, 30-day mortality, and long-term survival. RESULTS: Patients undergoing elective aortobifemoral reconstruction (n = 672) exhibited significantly increased rates of smoking, chronic obstructive pulmonary disease, and peripheral artery disease in comparison to patients undergoing elective OSR with distal anastomosis to the aorta (n = 2298), common iliac artery (n = 2163), or external iliac artery (n = 550). Patients undergoing aorto-aortic tube grafting were significantly less likely to exhibit iliac aneurysmal disease and significantly more likely to be undergoing elective OSR with a suprarenal or supraceliac proximal clamp position. Using multivariable logistic regression and Cox proportional hazards analysis to control for important confounders, such as age, smoking status, and medical history, we found that distal anastomosis to the common femoral artery was associated with increased odds of major in-hospital complications (adjusted odds ratio, 1.79; 95% confidence interval, 1.46-2.18; P < .001) and reduced long-term survival (adjusted hazard ratio, 1.44; 95% confidence interval, 1.09-1.89; P = .010). We observed no significant differences in 30-day mortality across sites of distal anastomosis in our study population. CONCLUSIONS: It is generally accepted that more proximal sites of distal anastomosis should be selected in OSR when technically feasible. Our findings support this hypothesis by demonstrating that distal anastomosis to the common femoral artery is associated with increased perioperative morbidity and reduced long-term survival. Careful diligence regarding optimization of preoperative health status, perioperative care, and long-term follow-up should be applied to mitigate major complications in this patient population.

Techniques and Limitations of Gore Thoracoabdominal Multibranch Endoprosthesis (TAMBE) for Type 1A Endoleak After Failed Endovascular Aortic Repairs.

PURPOSE: Endovascular aortic aneurysm repair (EVAR) is the dominant treatment modality over open repair for abdominal aortic aneurysms. However, a higher rate of reinterventions remains the Achilles heel of EVAR. Although type 1A endoleak from proximal seal zone failure of EVAR remains one of the leading causes for reintervention, fenestrated branched devices suitable for proximal extension of failed EVAR are not widely available in the United States. Gore Thoracoabdominal Multibranch Endoprosthesis (TAMBE) is an off-the-shelf investigational device that provides supraceliac seal by incorporating 4 visceral and renal arteries via preloaded inner branches. CASE REPORT: In this article, we describe 2 cases of type 1A endoleak from previous EVAR devices repaired using TAMBE. Both cases were performed under the Food and Drug Administration (FDA) compassionate use exemption. Considerations on the case planning and implantation techniques of TAMBE specific to previous EVAR devices are reviewed. CONCLUSIONS: Gore TAMBE can be utilized to repair a type 1A endoleak of a previous infrarenal EVAR device. Greater supraceliac coverage necessary for TAMBE relative to the minimal seal zone should be considered when applying this device for a type 1A endoleak. CLINICAL IMPACT: This report demonstrates the feasibility of applying off-the-shelf TAMBE device to treat one of the most common failure modes of EVAR, type1A endoleak.

Dual-Lumen Stenting of Dissected Superior Mesenteric Artery During Fenestrated Branched Endovascular Repair of a Post-dissection Thoracoabdominal Aortic Aneurysm.

PURPOSE: Long-segment aortic branch dissections have been considered a relative contraindication for fenestrated-branched endovascular aneurysm repair (FB-EVAR). This case report describes a technique of dual-lumen stenting of a fully-dissected superior mesenteric artery (SMA) to preserve patency of the true and false lumens during FB-EVAR. CASE REPORT: A 67-year-old man presented with a 6.0 cm extent III chronic post-dissection thoracoabdominal aortic aneurysm. The patient had highly-complex anatomy including dissection of the entire SMA. The true and false lumens of the dissected SMA were noted to be supplying different branches, requiring preservation of both lumens. The patient underwent a staged physician-modified FB-EVAR. A modified endograft containing 5 fenestrations and 1 branch cuff was introduced and the celiac, true-lumen SMA, and 3 renal arteries were sequentially catheterized using staggered deployment of the modified endograft. The false lumen SMA stent was catheterized via the branch cuff. Molded parallel grafting ("eye-of-the-tiger") technique was used to achieve double D configuration between the true and false lumens of the SMA. CONCLUSION: This case demonstrates feasibility of dual-lumen stenting to incorporate dissected target vessels during FB-EVAR while preserving flow to both the true and false lumens and the second-order branches they supply. CLINICAL IMPACT: We report a novel technique that allows incorporation of branch vessels affected by long segment dissection during fenestrated branched endovascular aortic repairs. This has potential advantage of preserving flow to all secondary branches of the dissected target vessels, while reducing the risk of type Ic endoleak.

Risk Factors for Cerebral Hyperperfusion Syndrome following Carotid Revascularization.

BACKGROUND: Cerebral hyperperfusion syndrome (CHS) is a rare but known complication of carotid revascularization that can result in severe postoperative disability and death. CHS is a well-described sequela of carotid endarterectomy (CEA) and, more recently, of transfemoral carotid artery stenting (TFCAS), but its incidence after transcarotid artery revascularization (TCAR) has not been delineated. The aims of this study were to determine the impact of procedure type (CEA versus TCAR versus TFCAS) on the development of CHS as well as to identify perioperative risk factors associated with CHS. METHODS: The Society for Vascular Surgery Vascular Quality Initiative was queried for patients aged ≥18 years who underwent CEA, TCAR, or TFCAS from 2015-2021. Emergent procedures were excluded. The primary outcome was postoperative development of CHS, defined as the presence of postoperative seizures, intracerebral hemorrhage due to hyperperfusion, or both. Bivariate and multivariable logistic regression analyses were performed to identify factors associated with CHS. RESULTS: 156,003 procedures were included (72.7% CEA, 12.4% TCAR, and 14.9% TFCAS). The incidence of CHS after CEA, TCAR, and TFCAS were 0.15%, 0.18%, and 0.53%, respectively. There was no significant difference in risk of CHS after TFCAS compared to CEA (odds ratio [OR]: 1.21; 95% confidence interval [CI] 0.76-1.92; P = 0.416), nor was there a difference between TCAR and CEA (OR: 0.91; 95% CI 0.57-1.45; P = 0.691). Perioperative risk factors associated with an increased risk of CHS included previous history of transient ischemic attack or stroke (OR: 2.50; 95% CI 1.69-3.68; P < 0.0001), necessity for urgent intervention within 48 hr (OR: 2.03; 95% CI 1.43-2.89; P < 0.0001), treatment of a total occlusion (OR: 3.80; 95% CI 1.16-12.47; P = 0.028), and need for postoperative intravenous blood pressure medication (OR: 5.45; 95% CI 3.97-7.48; P < 0.0001). Age, preoperative hypertension, degree of ipsilateral stenosis less than or equal to 99%, and history of prior carotid procedures were not statistically associated with an increased risk of CHS. Discharging patients on an angiotensin-converting enzyme inhibitor or angiotensin II receptor blocker was associated with a decreased risk of developing CHS (OR: 0.47; 95% CI 0.34-0.65; P < 0.0001). CONCLUSIONS: Compared with CEA, TCAR and TFCAS were not statistically associated with an increased risk of postoperative CHS. Patients with a previous history of transient ischemic attack or stroke, who require urgent intervention or postoperative intravenous blood pressure medication, or who are treated for a total occlusion are at a higher risk of developing CHS. Using an angiotensin-converting enzyme inhibitor/angiotensin II receptor blocker on discharge appears to be protective against CHS and should be considered for the highest risk patients.

Risk of Stroke with Thoracic Endovascular Aortic Repair of the Aortic Arch.

BACKGROUND: Thoracic endovascular aortic repair (TEVAR) involving the aortic arch is increasingly being performed and novel endografts have been developed for this procedure, but the association of stroke and relative risk of procedural techniques remains unclear. This study evaluates the procedural risk factors for stroke and mortality with zone 0-2 TEVAR. METHODS: The Society for Vascular Surgery Vascular Quality Initiative registry was queried for patients who underwent TEVAR with proximal landing in zone 0-2 from 2013 to 2022. Emergent and ruptured cases were excluded. Primary exposure variables included proximal seal zone (0-2) and branch vessel revascularization technique: open debranching/bypass, total endovascular incorporation, or combination (at least 1 branch open and 1 branch endovascular). The primary outcome was perioperative inhospital stroke and the secondary outcome was inhospital mortality. Univariable and multivariable regression analyses were performed. RESULTS: In total, 4,355 cases were analyzed with 350 in zone 0 (8%), 513 in zone 1 (12%), and 3,492 in zone 2 (80%). For zone 0, 1, and 2, the stroke rates were 11.1%, 5.3% and 4.7% (P < 0.0001) and inhospital mortality rates were 6.9%, 5.3% and 3.5% (P = 0.002), respectively. Branch vessel revascularization technique was associated with stroke in zone 0 with a 3-fold higher stroke rate for total endovascular incorporation of branches compared to combination and open techniques (P = 0.002). On multivariable analysis, zone 0 was independently associated with a greater than 2-fold increased odds of stroke compared to zone 2 (95% CI 1.4-3.2, P = 0.0008). CONCLUSIONS: Stroke rate was 2-3 times higher for zone 0 TEVAR compared to zones 1 and 2. Within zone 0, total endovascular branch incorporation was associated with a 3-fold higher stroke rate than open and combination techniques. Future device design modifications and novel endovascular strategies for stroke prevention are required to make total endovascular repair of the aortic arch an acceptable alternative to combination and open debranching/bypass techniques.

One-year results of the GORE EXCLUDER Conformable AAA Endoprosthesis system in the United States regulatory trial.

OBJECTIVE: To report the 1-year clinical outcomes from the GORE EXCLUDER Conformable AAA Endoprosthesis system in the US regulatory trial. METHODS: The study is a prospective, multicenter, investigational device exemption clinical trial at 31 US sites with core laboratory assessment of imaging and independent event adjudication. The primary safety (incidence of major adverse events at 30 days) and effectiveness end points (successful aneurysm treatment at 1 year) were assessed in a cohort of patients with abdominal aortic aneurysms (AAAs). RESULTS: We enrolled 80 patients between December 19, 2017, and February, 27, 2019. The mean maximum aortic diameter was 57.7 ± 7.95 mm (range, 42.5-82.7 mm) with an average patient age of 73.5 ± 8.14 years (range, 56-96 years). Overall technical success was 100% (80/80). The mean hospital length stay was 1.2 ± 0.6 days (range, 1-4 days). No primary safety end point events were observed, including no death, stroke, myocardial infarction, bowel ischemia, paraplegia, respiratory failure, renal failure, procedural blood loss of more than 1000 mL, or thromboembolic events including limb occlusion or distal emboli. There were no type I or III endoleaks detected on the 1-, 6-, or 12-month follow-up computed tomography scans. There were no stent fractures, device migrations (≥10 mm), AAA ruptures, or conversions to open surgical repair observed. Two patients had AAA sac growth of more than 5 mm at 1 year owing to type II endoleaks. There were no aneurysm-related deaths within the 12-month follow-up, and freedom from aneurysm-related mortality was 100% through 1 year. CONCLUSIONS: The safety and effectiveness of the GORE EXCLUDER Conformable AAA Endoprosthesis system has been demonstrated with 98.5% freedom from primary effectiveness end point events at 1 year and 100% freedom from primary safety end point events assessed through 30 days.

Transposition of anomalous left vertebral to carotid artery during the management of thoracic aortic dissections and aneurysms.

OBJECTIVES: Preservation of antegrade flow to the left vertebral artery (LVA) is often achieved by transposition or bypass to the left subclavian artery during zone 2 thoracic endovascular aortic repair. An anomalous LVA (aLVA) originating directly from the aortic arch is a common arch variant with a reported incidence of 4% to 6%. In addition, 6% to 10% of vertebral arteries terminate in a posterior inferior cerebellar artery, increasing the risk of stroke if not revascularized. Few series of aLVA to carotid transposition have been reported. The aim of this study was to evaluate the outcomes of patients who underwent aLVA to carotid transposition for the management of aortic disease. METHODS: A retrospective review of all aLVA-carotid transpositions performed for the management of thoracic aortic dissection or aneurysm at a single center from 2018 to 2021 was performed. The primary outcomes were postoperative stroke and patency of the transposed aLVA. Secondary outcomes were spinal cord ischemia, postoperative cranial nerve injury, and Horner's syndrome. RESULTS: Seventeen patients underwent aLVA to carotid transposition as an adjunct to management of aortic disease during the study period. Most were men (n = 14) and the mean age was 54 ± 16 years. The primary indication for aortic repair was dissection in 10, aneurysm in 6, and Kommerell diverticulum in 1. Nine patients underwent zone 2 thoracic endovascular aortic repair, seven received open total arch repair, and there was one attempted total endovascular arch repair that was aborted owing to unfavorable anatomy. Twelve transpositions were performed before or concomitant with planned aortic repair owing to high-risk cerebrovascular anatomy (three posterior inferior cerebellar artery termination, six dominant aLVA, four intracranial LVA stenosis), and two were performed postoperatively for treatment of type II endoleak. LVA diameter ranged from 2 to 6 mm (mean, 3.3 mm). The mean operative time for transposition was 178 ± 38 minutes, inclusive of left subclavian artery revascularization, and the mean estimated blood loss was 169 ± 188 mL. No patients experienced 30-day postoperative spinal cord ischemia, stroke, or mortality. There were two cases of postoperative hoarseness, presumably owing to recurrent laryngeal nerve palsy, both of which resolved within 4 months. There were no cases of Horner's syndrome. At follow-up (mean, 306 days; range, 6-714 days), all transpositions were patent. CONCLUSIONS: Vertebral-carotid transposition is a safe and effective adjunct in the management of aortic disease with anomalous origin of the LVA.

Impact of high-risk features and timing of repair for acute type B aortic dissections.

OBJECTIVE: The new Society for Vascular Surgery/Society for Thoracic Surgery reporting standards for type B aortic dissection (TBAD) categorize clinical presentations of aortic dissection into uncomplicated, high-risk features (HRF), and complicated groups. Although it is accepted that complicated dissections require immediate repair, the optimal timing of repair for HRF has yet to be established. This study aims to identify the ideal timing of thoracic endovascular aortic repair (TEVAR) for HRF, as well as outcomes associated with specific HRF. METHODS: The Vascular Quality Initiative was queried for TEVARs performed for acute and subacute TBAD with HRF from 2014 to 2020. Rupture, malperfusion, and uncomplicated patients were excluded. HRF were defined per the guidelines as refractory hypertension, pain, or rapid expansion/aneurysm of more than 40 mm. The primary outcomes were in-hospital/30-day mortality and 1-year survival with primary exposure variables being days from symptoms to repair and number of HRFs. Secondary outcomes were spinal cord ischemia, stroke, and retrograde type A dissection (RTAD). RESULTS: Of the 1100 patients who met inclusion criteria, 811 had one HRF, 249 had two, and 40 had three. There were no significant differences in primary or secondary outcomes based on number of HRFs. There were 309 patients who underwent repair at 0 to 2 days, 262 at 3 to 6 days, 270 at 7 to 14 days, and 259 at 15 days or more. TEVAR performed at 15 days or more was independently associated with lower in-hospital/30-day mortality (odds ratio, 0.38; P = .0388) and improved 1-year survival. Postoperative stroke was associated with earlier repair (0-2 days). There was no association of timing of repair with spinal cord ischemia, retrograde type A dissection or reintervention. CONCLUSIONS: TEVAR for TBAD with HRF delayed at least 15 days from symptom onset is associated with improved survival, supporting the theory that it is best to delay TEVAR until the subacute phase. Additionally, TEVAR delayed at least 3 days is associated with a decrease in stroke. Having more than one HRF was not associated statistically with worse outcomes. Because the classification of HRF is relatively new and without guidelines for repair, this study highlights the risks of early intervention for HRF and suggests that these patients seem to benefit from at least a short stabilization period before TEVAR.

Comparative early results of in situ fenestrated endovascular aortic repair and other emergent complex endovascular aortic repair techniques for ruptured suprarenal and thoracoabdominal aortic aneurysms at a regional aortic center.

INTRODUCTION: Emergent endovascular repair of suprarenal (SRAAAs) and thoracoabdominal aortic aneurysms (TAAAs) poses a significant challenge due to the need for branch vessel incorporation, time constraints, and lack of dedicated devices. Techniques to incorporate branch vessels have included parallel grafting, physician-modified endografts, double-barrel/reversed iliac branch device, and in situ fenestration (ISF). This study describes a single-center experience and the associated outcomes when using these techniques for ruptured SRAAAs and TAAAs. METHODS: A retrospective review of patients who underwent endovascular repair of ruptured SRAAAs and TAAAs from July 2014 to March 2021 with branch vessel incorporation was performed. Clinical presentation, intraoperative details, and postoperative outcomes of those who underwent ISF were compared with those who underwent repair using non-ISF techniques. The primary outcome of interest was in-hospital mortality. Secondary outcomes were major adverse events including myocardial infarction, respiratory failure, renal dysfunction, new onset dialysis, bowel ischemia, stroke, and spinal cord ischemia. RESULTS: Forty-two patients underwent endovascular repair for ruptured SRAAAs and TAAAs, 18 of whom underwent ISF repair. Seventy-two percent of ISF patients were hypotensive before surgery, compared with 46% of the patients who underwent repair using non-ISF techniques (physician-modified endografts, parallel grafting, or double-barrel/reversed iliac branch device). The total procedural and fluoroscopy times were similar between the two groups despite a greater mean number of branch vessels incorporated with the ISF technique (3.1 vs 2.2 per patient, P = .015). In-hospital mortality was 19% for all ruptures and 25% for ruptures with hypotension. Compared with the non-ISF group, in-hospital mortality trended lower in the ISF group (11% vs 25%, P = .233), reaching statistical significance when comparing patients who presented with hypotension (8% vs 45%, P = .048). The rate of major adverse events was 57% across all techniques and did not significantly differ between the ISF and non-ISF groups, with postoperative renal dysfunction being the most frequent complication (48%). Overall, ISF became the most commonly used technique later in the study period. CONCLUSIONS: Although emergent endovascular repair of ruptured SRAAAs/TAAAs remains a challenge, a number of techniques are available for expeditious treatment. In this series, ISF was associated improve survival, including a fivefold reduction in mortality in patients presenting with hypotension, and has now become the dominant technique at our center. Despite these advantages, postoperative complications and reinterventions are common. Further experience and longer-term follow-up are needed to validate these initial results and assess durability.

Aortic visceral segment instability is evident following thoracic endovascular aortic repair for acute and subacute type B aortic dissection.

BACKGROUND: Anatomic remodeling within the thoracic aorta following thoracic endovascular aortic repair (TEVAR) for type B aortic dissection (TBAD) has been well documented. However, less is known about the response of the untreated visceral aorta. In the present study, we investigated the visceral aortic behavior after TEVAR for acute or subacute TBAD to identify any associations with the clinical outcomes. METHODS: A multicenter retrospective review was performed of all imaging studies for all patients who had undergone TEVAR for acute (0-14 days) and subacute (14-90 days) nontraumatic TBAD from 2006 to 2020. The cohort was inclusive of those with uncomplicated, high-risk, and complicated (defined in accordance with the Society for Vascular Surgery reporting guidelines) dissections. Centerline aortic measurements of the true and false lumen and total aortic diameter (TAD) were taken at standardized locations relative to the aortic anatomy within each aortic zone (the zones were defined by the Society for Vascular Surgery reporting guidelines). Diameter changes over time were evaluated using repeated measures mixed effects linear growth modeling. Visceral segment instability (VSI) was defined as any growth in the TAD of ≥5 mm within aortic zones 5 through 9. RESULTS: A total of 82 patients were identified. The median length of imaging follow-up was 2.1 years (interquartile range, 0.75-4.5 years), with 15% of the cohort having follow-up >5 years. VSI was present in 55% of the cohort, with an average maximal increase in the TAD of 10.4 ± 6.3 mm during a median follow-up of 2.1 years (interquartile range, 0.75-4.5 years). Approximately one third of the cohort had experienced rapid VSI (growth ≥5 mm in the first year), and 4.8% of the cohort had developed a large paravisceral aortic aneurysm (TAD ≥5 cm) secondary to VSI. Linear growth modeling identified significant predictable growth in the TAD across all visceral zones. Zone 7 had the highest rate of TAD dilation, with a fixed effect estimated rate of 1.3 mm/y (95% confidence interval [CI], 0.23-2.1; P = .022). The preoperative factor most strongly associated with VSI was a cumulative number of zones dissected of six or more (odds ratio, 6.4; 95% CI, 1.07-8.6; P = .041). The odds for aortic reintervention were significantly increased for cases in which VSI led to the development of a paravisceral aortic aneurysm of ≥5 cm (odds ratio, 3.7; 95% CI, 1.1-13; P = .038). CONCLUSIONS: VSI was identified in most patients who had undergone TEVAR for management of acute and subacute TBAD. The preoperative anatomic features such as the dissection extent, rather than the procedural details of graft coverage, might play a more significant role in VSI occurrence. Significant TAD growth had occurred in all visceral segments. These results highlight the importance of lifelong surveillance following TEVAR and identified a subset of patients who might have an increased risk of reintervention.

Outcomes of endovascular repair of aortic aneurysms with the GORE thoracic branch endoprosthesis for left subclavian artery preservation.

OBJECTIVE: Thoracic endovascular aortic repair has emerged as the dominant paradigm for treatment of patients with descending thoracic aortic aneurysms. For aneurysms involving the aortic arch in the region of the left subclavian artery (LSA), branch vessel preservation to maintain blood flow to the LSA is recommended. Branched aortic endografts are an alternative to surgical revascularization of the LSA. METHODS: Across 34 investigative sites, 84 patients with zone 2 aneurysms were enrolled in a nonrandomized, prospective study of a single branched aortic endograft. The thoracic branch endoprosthesis device allows for graft placement proximal to the LSA and incorporates a single side branch for left subclavian perfusion. RESULTS: More than one-half of the patients were male (63%). Their average age was 70 ± 11 years. The aneurysm morphology was fusiform in 43 and saccular in 41 patients. The mean aneurysm diameter at screening was 56.2 mm. The mean follow-up was 30 months (range, 2.6-50.7 months). Reported here are the patient outcomes at 1 and 12 months. Predefined technical success with implantation of the device in landing zone 2 was achieved in 92% of patients (n = 77). There were no cases of aortic rupture, lesion-related mortality, or new-onset renal failure. There was no perioperative (30-day) mortality. A single case each of permanent paraplegia and paraparesis occurred. Three patients experienced a procedure-related stroke. Through 12 months, four patients died; none of the deaths were adjudicated as related to the device or procedure. One aortic reintervention was required. A single case of aortic enlargement (core laboratory) was reported at 6 months. Type I (n = 3) and III (n = 5) endoleaks occurred in 9.8% of patients, of which one (type III) required reintervention. CONCLUSIONS: Results from this device study in patients with zone 2 aneurysms demonstrate that early safety and efficacy outcomes are maintained up to 12 months after the endovascular procedure with low mortality and reintervention rates and an acceptable frequency of procedural complications, including neurologic complications.

Early Results and Technical Tips of Combining Iliac Branch Endoprostheses with Fenestrated Aortic Stent Grafts during Endovascular Repair of Complex Abdominal and Thoracoabdominal Aortic Aneurysms.

BACKGROUND: Concomitant iliac artery aneurysms can pose challenges during repair of complex abdominal and thoracoabdominal aortic aneurysms. In fenestrated aortic aneurysm repairs (FEVAR), preservation of internal iliac perfusion is important to minimize risk of spinal cord ischemia. Currently, most commonly used fenestrated stent grafts and the only approved iliac branch devices are manufactured by different companies in the United States. We report our experience with combining Iliac Branch Endoprosthesis (IBE) (W.L. Gore and Associates, Flagstaff, AZ) and fenestrated stent grafts, using the Zenith platform (Cook Medical, Bloomington, IN). METHODS: Retrospective review of consecutive patients who underwent FEVAR at a single institution from September, 2015 to June, 2020 was performed. Patients were deemed high-risk for open repair. Fenestrated aortic components implanted were either physician-modified or custom manufactured. Cases in which IBEs were deployed during FEVAR were specifically reviewed. Anatomic details were obtained from preoperative CT scans. Postoperative outcomes such as mortality, technical success, major adverse events, limb patency, limb-related endoleaks and re-intervention rates were assessed. RESULTS: During the study period, 171 patients underwent FEVAR at our institution. Among those, 15 patients had unilateral IBE implantation during FEVAR, while one received bilateral IBE implantation. Fourteen cases involved physician-modified fenestrated endograft, and Zenith Fenestrated (Cook Medical, Bloomington, IN) in combination with Excluder bifurcated main body and IBE (W.L. Gore and Associates, Flagstaff, AZ). Mean operative, and fluoroscopy times were 340.2 minutes, and 65.4 minutes respectively. A total of 67 viscerorenal target vessels (mean = 3.9, range =_3-5) and 15 internal iliac arteries were incorporated, with a mean of 160 cc contrast used. Completion angiograms were free of type 1 and type 3 endoleaks. Technical success was 100%. There was no perioperative mortality. One patient developed spinal cord ischemia post-operative day two with neurological recovery. At mean follow-up of 430 days, overall survival was 100% with no aneurysm-related mortalities. Limb patency remained 100%. There were no type 3 endoleaks while one patient had a type 1B endoleak that is currently being monitored. There was one re-intervention for type 1C renal branch graft endoleak. CONCLUSION: Combining IBE with FEVAR allows internal iliac preservation during endovascular repair of complex abdominal aortic aneurysms, with encouraging early results.

Impact of Perioperative Blood Transfusion in Anemic Patients Undergoing Infra Inguinal Bypass.

OBJECTIVE: Patients who present with lower extremity ischemia are frequently anemic and the optimal transfusion threshold for this cohort remains controversial. We sought to evaluate the impact of blood transfusion on postoperative major adverse cardiac events (MACE), including myocardial infarction, dysrhythmia, stroke, congestive heart failure, and 30-day mortality for these patients. METHODS: All consecutive patients who underwent infra-inguinal bypass at our institution from 2011 to 2020 were included. Perioperative red blood cell transfusion was the primary exposure, and the primary outcome was MACE. Univariate and multivariable analyses were performed to assess the impact of patient and procedural variables, including red blood cell transfusion, stratified by hemoglobin (Hgb) nadir: <7, 7-8, and >8 g/dL. RESULTS: Of the 287 patients reviewed for analysis, 146 (50.9%) had a perioperative transfusion (mean: 1.6 ± 3 units). Patients who received a transfusion had a mean nadir Hgb of 8.3 ± 1.0 g/dL, compared to 10.1 ± 1.7 g/dL without a transfusion. The overall incidence of MACE was 15.7% (45 of 287 patients). Univariate analysis demonstrated that MACE was associated with blood transfusion (P = 0.009), lower Hgb nadir (P = 0.02), and higher blood loss (P = 0.003). On multivariate analysis, transfusion was independently associated with MACE for patients with a Hgb nadir >8 g/dL (OR: 3.09; P = 0.006), but not for patients with Hgb nadir 7-8 g/dL (OR: 0.818; P = 0.77). Additionally, patients with MACE had significantly longer length of hospital stay than for patients without (13 vs. 7.7 days, P = 0.001). CONCLUSIONS: For patients undergoing infra-inguinal bypass, receiving a red blood cell transfusion with a Hgb nadir >8 g/dL was associated with a 3-fold increase in MACE, with nearly twice the length of stay. For patients with a Hgb 7-8 g/dL, transfusion did not increase or reduce the incidence of MACE. These findings suggest no benefit of blood transfusion for patients with Hgb nadir >7 g/dL and harm for Hgb >8 g/dL, however causation cannot be proven due to the retrospective nature of the study and randomized studies are needed to confirm or refute these findings.

Functional performance status and risk of cardiovascular events and mortality following endovascular repair of thoracic and abdominal aortic pathology.

OBJECTIVE: To characterize the association of preoperative functional performance status based on Eastern Cooperative Oncology Group (ECOG) scoring with the risk of adverse cardiovascular events, vascular events, and mortality in patients undergoing EVAR and TEVAR. METHODS: Retrospective review of the Society for Vascular Surgery Vascular Quality Initiative, a large, multi-center, registry database was performed. All individuals undergoing EVAR (n = 18,730) and TEVAR (n = 6595) for non-ruptured aortic pathologies between 2014 and 2018 were eligible for analysis. Multivariable logistic regression was used to determine the association of pre-procedure ECOG functional performance status on risk of in-hospital adverse cardiovascular events, vascular events, and mortality. RESULTS: The number of operations complicated by adverse cardiovascular and vascular events was 480 (2.6%) and 190 (1.0%) for EVAR and 733 (11.1%) and 219 (3.3%) for TEVAR, respectively. There were 118 (0.6%) and 240 (3.6%) in-hospital deaths following EVAR and TEVAR, respectively. Patients with ECOG grades 3 or 4 undergoing EVAR were at increased risk of cardiovascular events (OR = 1.62; 95% CI = 1.09, 2.41) and one-year mortality (HR = 2.62; 95% CI = 1.92, 3.57) compared to those with ECOG grade 0. Patients undergoing TEVAR with ECOG grade 3 or 4 were at increased risk for both inpatient death (OR = 2.77; 95% CI = 1.56, 4.9) and one-year mortality (HR = 3.27, 95% CI = 2.06, 5.21). ECOG status was not associated with an increased risk of adverse vascular events following either EVAR or TEVAR. CONCLUSIONS: Poor preoperative functional status as assessed by ECOG score is associated with an increased risk of adverse postoperative cardiovascular events following EVAR and a higher mortality risk following both EVAR and TEVAR. Functional status assessment may be useful for risk stratification and determining procedural candidacy prior to EVAR and TEVAR.