5-Year Outcomes of Endovascular Treatment for Aortic Dissection From the Global Registry for Endovascular Aortic Treatment.

OBJECTIVE: Global Registry for Endovascular Aortic Treatment (GREAT) is an International prospective multicenter registry collecting real-world data on performance of W. L. Gore (Flagstaff, AZ) aortic endografts. The purpose is to analyze long term outcomes/patient survival and device performance in patients undergoing thoracic endovascular aortic repair (TEVAR) for acute/chronic and complicated/uncomplicated Type B aortic dissection (TBAD). METHODS: From August 2010 to October 2016, 5014 patients were enrolled in the GREAT registry. The study population were patients treated with TEVAR for TBAD through 5-year follow-up (day 0-2006). The primary outcomes for this analysis were all-cause and aortic-related mortality, stroke, aortic rupture, endoleaks, migration, fracture, compression, and any reintervention through 5-years. RESULTS: 265 patients were identified. Mean age was 60.9 ± 11.9 years [range, 19-84 years; 211 (79.6%) males]. Devices used were GORE® TAG® and Conformable GORE® TAG® Thoracic Endoprosthesis (TAG/CTAG) (W.L. Gore, Flagstaff, AZ). 228 patients (86.0%) underwent primary endovascular treatment [144 (54.3%) off-label]. 22 (8.3%) underwent reintervention after prior endovascular procedure, 15 (5.7%) underwent reintervention after prior open procedure. Kaplan-Meier estimated freedom from all-cause mortality at 5 years was 71.1%. Freedom from aortic-related mortality through 5 years was 95.8%. There was no significant difference in freedom from all-cause mortality during the follow-up period in complicated or uncomplicated disease. At 30 days and through 5 years respectively for all following outcomes, aortic rupture rate was 1.1% (n=3) and 1.9% (n=5). Stroke rate was 1.1% (n=3) and 4.2% (n=11). Spinal cord ischemic event rate was 1.5% (n=4) and 2.6% (n=7). Re-interventions were required in 6.4% (n=17) and 21.1% (n=56) of patients. Need for conversion to open repair was 0.4% (n=1) and 2.6% (n=7). Additional graft placement was required in 3 patients (1.1%) and 16 patients (6.0%). Endoleak rate at 30 days was 3.4% [n=9; Type IA (n=1; 0.4%), Type IB (n=4; 1.5%), Type II (n=1; 0.4%), Type III (n=1; 0.4%) and unspecified (n=4; 1.6%)]. Through 5 years, endoleak rate was 12.1% [n=32; Type IA (n=7; 2.6%), Type IB (n=10; 3.8%), Type II (n=9; 3.4%), Type III (n=2; 0.8%) and unspecified (n-12, 4.5%)]. There were no cases of stent migration, compression or fracture through 5 years. CONCLUSIONS: Results at 5-year follow-up demonstrate that the use of TAG/CTAG can be supported in treatment of TBAD (acute, chronic, complicated and uncomplicated). These data demonstrate strong device durability, beneficial patient outcomes, and support for treatment of thoracic aortic dissection with an endovascular approach. Complete 10-year follow-up in GREAT as planned will be advantageous.

Risk Factors for Stroke in Penetrating Cerebrovascular Injuries.

OBJECTIVE: Penetrating cerebrovascular injuries (PCVI) are associated with a high incidence of mortality and neurologic events. The optimal treatment strategy of PCVI, especially when damage control measures are required, remains controversial. The aim of this study is to describe the management of PCVI and patient outcomes at a level 1 trauma center where vascular injuries are predominantly managed by trauma surgeons. METHODS: An institutional trauma registry was queried for patients with PCVI from 2011-2021. Patients with common carotid artery (CCA), internal carotid artery (ICA), or vertebral artery (VA) injuries were included for analysis. The primary outcome was in-hospital stroke. The secondary outcomes were in-hospital mortality and in-hospital stroke or death. A subgroup analysis was completed of arterial repair (primary repair or interposition graft) vs ligation/embolization vs temporary intravascular shunting at the index procedure. RESULTS: 54 patients with PCVI were analyzed. Overall, the in-hospital stroke rate was 17% and in-hospital mortality was 26%. Twenty-one patients (39%) underwent arterial interventions for PCVI. Ten patients underwent arterial repair, 6 patients underwent ligation/embolization, and 5 patients underwent intravascular shunting as damage control strategy with a plan for delayed repair. The rate of in-hospital stroke was 30% after arterial repair, 0% after arterial ligation or embolization, and 80% after temporary intravascular shunting. There was a significant difference in the stroke rate between the three subgroups (P=.015). Of the 32 patients that that did not have an intervention to the CCA, ICA, or VA, 1 patient with ICA occlusion and 1 patient with CCA intimal injury developed in-hospital stroke. The mortality rate was 0% after arterial repair, 50% after ligation or embolization, and 60% after intravascular shunting. The rate of stroke or death was 30% in the arterial repair group, 50% in the ligation or embolization group, and 100% in the temporary intravascular shunting group. CONCLUSIONS: High rates of stroke and mortality were seen in patients requiring damage control after PCVI. In particular, temporary intravascular shunting was associated with a high incidence of in-hospital stroke and 100% rate of stroke or death. Further investigation is needed into the factors related to these finding and whether the use of temporary intravascular shunting in PCVI is an advisable strategy.

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.

Baroreflex activation therapy in patients with heart failure and a reduced ejection fraction: Long-term outcomes.

AIMS: Carotid baroreflex activation therapy (BAT) restores baroreflex sensitivity and modulates the imbalance in cardiac autonomic function in patients with heart failure with reduced ejection fraction (HFrEF). We tested the hypothesis that treatment with BAT significantly reduces cardiovascular mortality and heart failure morbidity and provides long-term safety and sustainable symptomatic improvement. METHODS AND RESULTS: BeAT-HF was a prospective, multicentre, randomized, two-arm, parallel-group, open-label, non-implanted control trial. New York Heart Association (NYHA) class III subjects, ejection fraction ≤35%, previous heart failure hospitalization or N-terminal pro-B-type natriuretic peptide (NT-proBNP) >400 pg/ml, no class I indication for cardiac resynchronization therapy and NT-proBNP <1600 pg/ml were randomized to BAT plus optimal medical management (BAT group) or optimal medical management alone (control). The primary endpoint was cardiovascular mortality and HF morbidity; additional pre-specified endpoints included durability of safety, quality of life (QOL), exercise capacity (6-min hall walk distance [6MHWD]), functional status (NYHA class), hierarchical composite win ratio, freedom from all-cause death, left ventricular assists device (LVAD) implantation, heart transplant. Overall, 323 patients had 332 primary events, median follow-up was 3.6 years/patient. Both primary endpoint (rate ratio 0.94, 95% confidence interval [CI] 0.57-1.57; p = 0.82) and components of the primary endpoints were not significantly different between BAT and control. The system- and procedure-related major adverse neurological and cardiovascular event-free rate remained 97% throughout the trial. Symptom improvement (QOL, 6MHWD, NYHA class, all nominal p < 0.001) in the BAT group was durable in time, sustainable in extent. Win ratio (1.26, 95% CI 1.02-1.58) and freedom from all-cause death, LVAD implantation, heart transplant (hazard ratio 0.66, 95% CI 0.43-1.01) favoured the BAT group but did not reach statistical significance. CONCLUSION: The BeAT-HF primary endpoint was neutral; however, BAT provided safe, effective, and sustainable improvements in HFrEF patient's functional status, 6MHWD and QOL.

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.

Endovascular treatment for thoracic aortic disease from the Global Registry for Endovascular Aortic Treatment.

OBJECTIVE: Global Registry for Endovascular Aortic Treatment (GREAT) is an international prospective multicenter registry collecting real-world data on performance of W. L. Gore thoracic and abdominal aortic endografts. This analysis evaluated the long-term differences in patient survival and device performance in patients undergoing thoracic endovascular aortic repair (TEVAR) for any thoracic aortic pathology. METHODS: From August 2010 to October 2016, 5014 patients were enrolled in GREAT. The population of interest was comprised of only patients treated for thoracic aortic pathologies. Through 5 years, primary outcomes were all-cause and aortic-related mortality, stroke, aortic rupture, endoleaks, migration, fracture, compression, paraplegia, and any reintervention through 5 years, grouped by pathology. Secondary outcomes were reintervention rate and freedom from serious device- and aortic-related events. RESULTS: The 578 patients with thoracic aortic pathologies enrolled in GREAT and identified for this analysis were categorized by common pathologies: thoracic aneurysm (n = 239), thoracic dissection (n = 203), arch (n = 26), and other (n = 110). The mean age of this population was 66.1 ± 12.8 years, and 64.7% were male. Procedure survival was 99.7%. In the overall group, at index procedure to 30 days and 31 days to 5 years, Kaplan-Meier estimates of freedom from all-cause mortality were 99.6% and 66.4%, respectively, and for aortic-related mortality were 97.7% and 94.6%, respectively. Aortic rupture rate was 0.5% (n = 3) at 30 days and 1.4% (n = 8) through 5 years. Stroke and spinal cord ischemic events were 1.9% (n = 11) and 1.6% (n = 9) at 30 days and at 5 years were 3.6% (n = 20), 0.5% (n = 3), respectively. Reinterventions were required in 7.3% (n = 42) at 30 days and 12.4% (n = 69) through 5 years. The number of patients with endoleaks at 30 days was 2.1% (n = 12): n = 3 (1.1%) for each of types IA, 1B, and II; n = 2 (0.3%) for type III; and n = 4 (0.7%) for unspecified. Through 5 years, the percentage of patients was 8.3% (n = 40): n = 15 (3.1%) for type IA; n = 10 (2.1%) for type IB; n = 11 (2.3%) for type II; and n = 9 (1.9%) for unspecified. One patient (0.2%) had stent migration at 30 days (aneurysm group); none were reported through 5 years. There were no incidents of stent compression or fracture from index procedure through 5 years. CONCLUSIONS: Data herein demonstrates durability and support for treatment of thoracic aortic disease with the GORE TAG conformable thoracic stent graft, including no incidents of stent compression/fracture and high freedom from aortic-related mortality. The planned analysis of follow-up to 10 years in GREAT will be beneficial.

Epidemiology, repair technique, and predictors of stroke and mortality in penetrating carotid artery injuries.

OBJECTIVE: Penetrating carotid artery injuries (PCAI) are significantly morbid and deadly, often presenting in extremis with associated injuries and central nervous system deficit. Repair may be challenging with arterial reconstruction vs ligation role poorly defined. This study evaluated contemporary outcomes and management of PCAI. METHODS: PCAI patients in the National Trauma Data Bank from 2007 to 2018 were analyzed. Outcomes were compared between repair and ligation groups after additionally excluding external carotid injuries, concomitant jugular vein injuries, and head/spine Abbreviated Injury Severity score of ≥3. Primary end points were in-hospital mortality and stroke. Secondary end points were associated injury frequency and operative management. RESULTS: There were 4723 PCAI (55.7% gunshot wounds, 44.1% stab wounds). Gunshot wounds more frequently had associated brain (73.8% vs 19.7%; P < .001) and spinal cord (7.6% vs 1.2%; P < .001) injuries; stab wounds more frequently had jugular vein injuries (19.7% vs 29.3%; P < .001). The overall in-hospital mortality was 21.9% and the stroke rate was 6.2%. After exclusion criteria, 239 patients underwent ligation and 483 surgical repair. Ligation patients had lower presenting Glasgow Coma Scale (GCS) than repair patients (13 vs 15; P = .010). Stroke rates were equivalent (10.9% vs 9.3%; P = .507); however, in-hospital mortality was higher after ligation (19.7% vs 8.7%; P < .001). In-hospital mortality was higher in ligated common carotid artery injuries (21.3% vs 11.6%; P = .028) and internal carotid artery injuries (24.5% vs 7.3%; P = .005) compared with repair. On multivariable analysis, ligation was associated with in-hospital mortality, but not with stroke. A history of neurological deficit before injury lower GCS, and higher Injury Severity Score (ISS) were associated with stroke; ligation, hypotension, higher ISS, lower GCS, and cardiac arrest were associated with in-hospital mortality. CONCLUSIONS: PCAI are associated with a 22% rate of in-hospital mortality and a 6% rate of stroke. In this study, carotid repair was not associated with a decreased stroke rate, but did have improved mortality outcomes compared with ligation. The only factors associated with postoperative stroke were low GCS, high ISS, and a history of neurological deficit before injury. Beside ligation, low GCS, high ISS, and postoperative cardiac arrest were associated with in-hospital mortality.

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.

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.

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.

Selection criterion for endovascular aortic repair in those with chronic kidney disease.

OBJECTIVE: Endovascular aortic repair (EVAR) is the preferred method of repair for abdominal aortic aneurysms (AAAs). However, patients with advanced chronic kidney disease (CKD) are a high-risk group, and it is unknown which patients with CKD benefit from EVAR vs continued surveillance. The purpose of this study was to identify which patients with advanced CKD may benefit from EVAR. METHODS: The Vascular Quality Initiative Database was utilized to identify elective EVARs for AAAs. Patients were excluded if they underwent urgent or emergent repairs. CKD stages were categorized based on preoperative estimated glomular filtration rate (eGFR) and dialysis status. Predicted 1-year mortality of untreated AAAs was calculated by modifying a validated comorbidity score that predicts 1-year mortality (Gagne Index) without repair. The primary outcome was actual 1-year mortality, which was compared with the predicted 1-year mortality without repair. RESULTS: A total of 34,926 patient met study criteria. There were differences in Gagne Indices among the varying classes of CKD. Patients with CKD 4 and CKD 5 had the highest 1-year mortality rates, followed by CKD 3b, which was significantly higher than those with CKD 1 and CKD 2. Patients with CKD 4 had no differences between actual 1-year mortality with EVAR and predicted 1-year survival without EVAR across all AAA sizes. Those with CKD 5 had worse actual 1-year survival with EVAR than predicted 1-year survival without EVAR for AAAs <5.5 cm. Patients with CKD 5 only experienced an actual mortality benefit with EVAR compared with predicted 1-year mortality without EVAR for AAAs ≥7.0 cm. CONCLUSIONS: The current data suggest that patients with CKD 3b, 4, and 5 represent a high-risk group who may not benefit from elective EVAR utilizing traditional size criteria. Patients with CKD 4 and 5 with AAAs <5.5 cm do not benefit from elective EVAR. In patients with CKD 5, elective EVAR may need to be reserved for AAAs ≥7.0 cm unless there are other concerning anatomic characteristics.

Endovascular treatment of complicated versus uncomplicated acute type B aortic dissection.

OBJECTIVE: The study objective was to analyze the outcomes of thoracic endovascular aortic repair performed for complicated and uncomplicated acute type B aortic dissections. METHODS: Patients from WL Gore's Global Registry for Endovascular Aortic Treatment who underwent thoracic endovascular aortic repair for acute type B aortic dissections were included, and data were retrospectively analyzed. RESULTS: Of 5014 patients enrolled in the Global Registry for Endovascular Aortic Treatment, 172 underwent thoracic endovascular aortic repair for acute type B aortic dissections. Of these repairs, 102 were for complicated acute type B aortic dissections and 70 were for uncomplicated acute type B aortic dissections. There were 46 (45.1%) procedures related to aortic branch vessels versus 15 (21.4%) in complicated type B aortic dissections and uncomplicated type B aortic dissections (P = .002). The mean length of stay was 14.3 ± 10.6 days (median, 11; range, 2-75) versus 9.8 ± 7.9 days (median, 8; range, 0-42) in those with complicated type B aortic dissections versus those with uncomplicated acute type B aortic dissections (P < .001). Thirty-day mortality was not different between groups (complicated type B aortic dissections 2.9% vs uncomplicated acute type B aortic dissections 1.4%, P = .647), as well as aortic complications (8.8% vs 5.7%, P = .449). Aortic event-free survival was 62.9% ± 37.1% versus 70.6% ± 29.3% at 3 years (P = .696). CONCLUSIONS: In the Global Registry for Endovascular Aortic Treatment, thoracic endovascular aortic repair results for complicated type B aortic dissections versus uncomplicated acute type B aortic dissections showed that 30-day mortality and perioperative complications were equally low for both. The midterm outcome was positive. These data confirm that thoracic endovascular aortic repair as the first-line strategy for treating complicated type B dissections is associated with a low risk of complications. Further studies with longer follow-up are necessary to define the role of thoracic endovascular aortic repair in uncomplicated acute type B dissections compared with medical therapy. However, in the absence of level A evidence from randomized trials, results of the uncomplicated acute type B aortic dissection patient cohort treated with thoracic endovascular aortic repair from registries are important to understand the related risk and benefit.

Perioperative and long-term outcomes after open conversion of endovascular aneurysm repair versus primary open aortic repair.

BACKGROUND: The use of endovascular abdominal aortic aneurysm repair (EVAR) has superseded that of open aneurysm repair (OAR) as the procedure of choice for abdominal aortic aneurysm repair. However, significant rates of late reintervention and aneurysm rupture have been reported after EVAR, resulting in the need for conversion to OAR (C-OAR). To assess the relative effects of C-OAR on patients, we compared the outcomes of these patients to those of patients who had undergone P-OAR. METHODS: The data from all patients who had undergone C-OAR and P-OAR in the Vascular Quality Initiative Vascular Implant Surveillance and Interventional Outcomes Network database from 2003 to 2018 were queried. Multivariable logistic regression and Kaplan-Meier survival and Cox proportional hazard regression analyses were used to assess the perioperative long-term outcomes. RESULTS: A total of 4763 patients were included (91.4%, P-OAR; 8.6%, C-OAR). C-OAR was associated with a significant increase in the odds of perioperative mortality (odds ratio, 1.7; 95% confidence interval [CI], 1.1-2.7; P = .027) and renal complications (odds ratio, 1.5; 95% CI, 1.1-2; P = .004) vs P-OAR. At 5 years, conversion was associated with a higher risk of mortality (hazard ratio [HR], 1.5; 95% CI, 1.3-1.9; P < .001), aneurysmal rupture (HR, 1.9; 95% CI, 1.2-3.1; P = .007), and reintervention (HR, 1.4; 95% CI, 1.05-1.97; P = .022) compared with P-OAR. These results also persisted at 10 years, with conversion associated with a higher risk of mortality (HR, 1.5; 95% CI, 1.2-1.8; P < .001), rupture (HR, 1.8; 95% CI, 1.1-2.8; P = .018), and reintervention (HR, 1.5; 95% CI, 1.1-2.1; P = .010). CONCLUSIONS: The results from the present study have demonstrated that C-OAR is associated with a significantly higher risk of perioperative morbidity and mortality compared with P-OAR. We found a significant increase in mortality, aneurysm rupture, and reintervention at 5 and 10 years of follow-up.

Renal Artery Aneurysms in the Inpatient Setting.

BACKGROUND: The risk of rupture of renal artery aneurysms (RAAs) remains undefined. A recent paper from the Vascular Low-Frequency Disease Consortium (VLFDC) identified only 3 ruptures in 760 patients. However, over 80% of patients in the VLFDC study were treated at large academic centers, which may not reflect the pattern of care of RAAs nationwide. Thus, the purpose of this study was to evaluate the pattern of nonelective versus elective surgery requiring inpatient admission for RAAs, including nephrectomies, and their outcomes using a national database. METHODS: The National Inpatient Sample (NIS) database from 2012 to 2018 was utilized. Patients with a primary diagnosis of RAAs were identified using ICD-9 and ICD-10 codes. Ruptured RAAs (rRAAs) were identified utilizing surrogate ICD codes. The primary outcome variables for this study were proportion of RAAs requiring non-elective surgery and in-hospital mortality. RESULTS: A total of 590 inpatient admissions for RAA were identified with 554 procedures at 467 hospitals across the country. Of the 590 inpatient admissions, 380 (64.4%) admissions were deemed nonelective. There was an increasing proportion of nonelective admissions over the study period. The overall rate of nephrectomies was 7.1% (n = 42). In-hospital mortality rate for the cohort was 1.4% (n = 8) with no differences in in-hospital mortality in the elective versus nonelective setting (1.0% vs. 1.6%; P = 0.718). In the nonelective setting, patients requiring a nephrectomy (n = 23) had significantly higher rates of in-hospital mortality compared those not requiring a nephrectomy (8.7% vs. 1.1%, P = 0.045). rRAA (n = 50) patients had significantly higher in-hospital mortality compared to the remainder of the cohort (6.0% vs. 0.9%, P = 0.024). rRAA patients were also more likely to undergo a nephrectomy compared to the remainder of the cohort (16.0% vs. 6.3%, P = 0.019). CONCLUSIONS: These data demonstrate that treatment of RAAs are primarily done in the nonelective setting with a high proportion of ruptures, which could continue to rise as the threshold for repair has decreased.

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.

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.

Baroreflex activation therapy with the Barostim™ device in patients with heart failure with reduced ejection fraction: a patient level meta-analysis of randomized controlled trials.

AIMS: Heart failure with reduced ejection fraction (HFrEF) remains associated with high morbidity and mortality, poor quality of life (QoL) and significant exercise limitation. Sympatho-vagal imbalance has been shown to predict adverse prognosis and symptoms in HFrEF, yet it has not been specifically targeted by any guideline-recommended device therapy to date. Barostim™, which directly addresses this imbalance, is the first Food and Drug Administration approved neuromodulation technology for HFrEF. We aimed to analyse all randomized trial evidence to evaluate the effect of baroreflex activation therapy (BAT) on heart failure symptoms, QoL and N-terminal pro-brain natriuretic peptide (NT-proBNP) in HFrEF. METHODS AND RESULTS: An individual patient data (IPD) meta-analysis was performed on all eligible trials that randomized HFrEF patients to BAT + guideline-directed medical therapy (GDMT) or GDMT alone (open label). Endpoints included 6-month changes in 6-min hall walk (6MHW) distance, Minnesota Living With Heart Failure (MLWHF) QoL score, NT-proBNP, and New York Heart Association (NYHA) class in all patients and three subgroups. A total of 554 randomized patients were included. In all patients, BAT provided significant improvement in 6MHW distance of 49 m (95% confidence interval [CI] 33, 64), MLWHF QoL of -13 points (95% CI -17, -10), and 3.4 higher odds of improving at least one NYHA class (95% CI 2.3, 4.9) when comparing from baseline to 6 months. These improvements were similar, or better, in patients who had baseline NT-proBNP <1600 pg/ml, regardless of the cardiac resynchronization therapy indication status. CONCLUSION: An IPD meta-analysis suggests that BAT improves exercise capacity, NYHA class, and QoL in HFrEF patients receiving GDMT. These clinically meaningful improvements were consistent across the range of patients studies. BAT was also associated with an improvement in NT-proBNP in subjects with a lower baseline NT-proBNP.

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.