Prospective evaluation of upper extremity access and total transfemoral approach during fenestrated and branched endovascular repair.

OBJECTIVE: Total transfemoral (TF) access has been increasingly used during fenestrated-branched endovascular aortic repair (FB-EVAR). However, it is unclear whether the potential decrease in the risk of cerebrovascular events is offset by increased procedural difficulties and other complications. The aim of this study was to compare outcomes of FB-EVAR using a TF vs upper extremity (UE) approach for target artery incorporation. METHODS: We analyzed the clinical data of consecutive patients enrolled in a prospective, nonrandomized clinical trial in two centers to investigate the use of FB-EVAR for treatment of complex abdominal aortic aneurysms (CAAA) and thoracoabdominal aortic aneurysms (TAAA) between 2013 and 2022. Patients were classified into TF or UE access group with a subset analysis of patients treated using designs with directional branches. End points were technical success, procedural metrics, 30-day cerebrovascular events defined as stroke or transient ischemic attack, and any major adverse events (MAEs). RESULTS: There were 541 patients (70% males; mean age, 74 ± 8 years) treated by FB-EVAR with 2107 renal-mesenteric TAs incorporated. TF was used in175 patients (32%) and UE in 366 patients (68%) including 146 (83%) TF and 314 (86%) UE access patients who had four or more TAs incorporated. The use of a TF approach increased from 8% between 2013 and 2017 to 31% between 2018 and 2020 and 96% between 2021 and 2022. Compared with UE access patients, TF access patients were more likely to have CAAAs (37% vs 24%; P = .002) as opposed to TAAAs. Technical success rate was 96% in both groups (P = .96). The use of the TF approach was associated with reduced fluoroscopy time and procedural time (each P < .05). The 30-day mortality rate was 0.6% for TF and 1.4% for UE (P = .67). There was no early cerebrovascular event in the TF group, but the incidence was 2.7% for UE patients (P = .035). The incidence of MAEs was also lower in the TF group (9% vs 18%; P = .006). Among 237 patients treated using devices with directional branches, there were no significant differences in outcomes except for a reduced procedural time for TF compared with UE access patients (P < .001). CONCLUSIONS: TF access was associated with a decreased incidence of early cerebrovascular events and MAEs compared with UE access for target artery incorporation. Procedural time was decreased in TF access patients irrespective of the type of stent graft design.

Aneurysm sac shrinkage at 1 year after fenestrated-branched endovascular aortic repair of complex aortic aneurysms offers mid-term survival advantage.

OBJECTIVES: To investigate the impact of 1-year changes in aneurysm sac diameter on patient survival after fenestrated-branched endovascular aortic repair (FB-EVAR) of complex abdominal aortic aneurysms or thoracoabdominal aortic aneurysms. METHODS: We reviewed the clinical data of patients enrolled in a prospective nonrandomized study investigating FB-EVAR (2013-2022). Patients with sequential follow up computed tomography scans at baseline and 6 to 18 months after FB-EVAR were included in the analysis. Aneurysm sac diameter change was defined as the difference in maximum aortic diameter from baseline measurements obtained in centerline of flow. Patients were classified as those with sac shrinkage (≥5 mm) or failure to regress (<5 mm or expansion) according to sac diameter change. The primary end point was all-cause mortality. Secondary end points were aortic-related mortality (ARM), aortic aneurysm rupture (AAR), and aorta-related secondary intervention. RESULTS: There were 549 patients treated by FB-EVAR. Of these, 463 patients (71% male, mean age, 74 ± 8 years) with sequential computed tomography imaging were investigated. Aneurysm extent was thoracoabdominal aortic aneurysms in 328 patients (71%) and abdominal aortic aneurysms in 135 (29%). Sac shrinkage occurred in 270 patients (58%) and failure to regress in 193 patients (42%), including 19 patients (4%) with sac expansion at 1 year. Patients from both groups had similar cardiovascular risk factors, except for younger age among patients with sac shrinkage (73 ± 8 years vs 75 ± 8 years; P < .001). The median follow-up was 38 months (interquartile range, 18-51 months). The 5-year survival estimate was 69% ± 4.1% for the sac shrinkage group and 46% ± 6.2% for the failure to regress group. Survival estimates adjusted for confounders (age, chronic pulmonary obstructive disease, chronic kidney disease, congestive heart failure, and aneurysm extent) revealed a higher hazard of late mortality in patients with failure to regress (adjusted hazard ratio, 1.72; 95% confidence interval, 1.18-2.52; P = .005). The 5-year cumulative incidences of ARM (1.1% vs 3.1%; P = .30), AAR (0.6% vs 2.6%; P = .20), and aorta-related secondary intervention (17.0% ± 2.8% vs 19.0% ± 3.8%) were both comparable between the groups. CONCLUSIONS: Aneurysm sac shrinkage at 1 year is common after FB-EVAR and is associated with improved patient survival, whereas sac enlargement affects only a minority of patients. The low incidences of ARM and AAR indicate that failure to regress may serve as a surrogate marker for nonaortic-related death.

Characterization of Secondary Interventions After Fenestrated-branched Endovascular Repair of Complex Aortic Aneurysms and Its Effect on Quality of Life and Patient Survival.

OBJECTIVE: To assess the impact of secondary intervention (SI) on health-related quality of life (HR-QOL) after fenestrated-branched endovascular aortic repair (FB-EVAR) for complex abdominal aortic aneurysms and thoracoabdominal aortic aneurysms. BACKGROUND: The effect of SI after FB-EVAR on physical and mental HR-QOL has not been described. METHODS: A cohort of 430 consecutive patients enrolled in a prospective, nonrandomized study to evaluate FB-EVAR (2013-2020) was assessed with 1325 short-form 36 HR-QOL questionnaires preoperatively and during follow-up visits. SIs were classified as major or minor procedures. Endpoints included patient survival, freedom from aortic-related mortality (ARM), freedom from SIs, and changes in HR-QOL physical component score (PCS) and mental component score. RESULTS: There were 302 male with mean age 74±8 years treated by FB-EVAR for 133 complex abdominal aortic aneurysms and 297 thoracoabdominal aortic aneurysms. After a mean follow up of 26±20 months, 97 patients (23%) required 137 SIs. At 5 years, freedom from any SI was 64%±4%, including freedom from minor SIs of 77%±4% and major SIs of 87%±3%. There was no difference in patient survival and freedom from ARM at same interval. On adjusted analysis, minor SIs correlated with improved survival. SIs had a negative correlation with PCS ( r =-0.8). There were no significant changes in mental component score with SIs. Predictors for SIs were fluoroscopy time, graft design, and aneurysm sac change. CONCLUSION: SIs were needed in nearly 1 out of 4 patients treated by FB-EVAR with no effect on patient survival or ARM. SI resulted in decline in PCS.

Dual Antiplatelet Alternatives are Associated With Increased Stroke and Death After Transcarotid Revascularization.

OBJECTIVE: To define the risks associated with the replacement of dual antiplatelets for alternate medication regimens. BACKGROUND: Patients undergoing transcarotid artery revascularization (TCAR) for atherosclerotic disease in the Vascular Quality Initiative database from September 2016 to June 2022 were included. In all, 29,802 TCAR procedures were captured between 2016 and 2022, consisting of 24,651 (82.7%) maintained on dual antiplatelet therapy (DAPT) and 5151 (17.3%) on alternative regimens. METHODS: Patients maintained on DAPT were compared with those on alternative regimens consisting of any combination of single antiplatelet monotherapy and/or anticoagulation. RESULTS: On univariable analysis, patients on alternative medications were more likely to experience in-hospital death, ipsilateral stroke, any stroke, and transient ischemic attacks compared with patients in the DAPT group. The mortality rate was higher at 1 year in the alternative cohort (4.7% vs 7.0%, P <0.01). The use of alternate medication regimens was associated with increased odds of stroke and the composite outcome of in-hospital stroke/death compared with DAPT. There was also a significant association between alternative medication use and increased odds of in-hospital transient ischemic attack, immediate stent occlusion, and return to the operating room. At 1 year, there was no significant difference in the incidence of stroke between the 2 groups. However, the use of alternate regimens was associated with higher 1-year of mortality after multivariable adjustment. CONCLUSIONS: Patients not maintained on DAPT after TCAR experienced an increased risk of stroke and death in the perioperative and follow-up periods. Increased surgeon vigilance is required to ensure compliance with dual antiplatelets as recommended.

Outcomes of iliofemoral conduits during fenestrated-branched endovascular repair of complex abdominal and thoracoabdominal aortic aneurysms.

OBJECTIVE: To describe the technical pitfalls and outcomes of iliofemoral conduits during fenestrated-branched endovascular repair (FB-EVAR) of complex abdominal aortic aneurysms (CAAAs) and thoracoabdominal aortic aneurysms (TAAAs). METHODS: We retrospectively reviewed the clinical data of 466 consecutive patients enrolled in a previous prospective nonrandomized study to investigate FB-EVAR for CAAAs/TAAAs (2013-2021). Iliofemoral conduits were performed through open surgical technique (temporary or permanent) in patients with patent internal iliac arteries or endovascular technique among those with occluded internal iliac arteries. End points were assessed in patients who had any iliac conduit or no conduits, and in patients who had conduits performed prior or during the index FB-EVAR, including procedural metrics, technical success, and major adverse events (MAE). RESULTS: There were 138 CAAAs, 141 extent IV, and 187 extent I-III TAAAs treated by FB-EVAR with an average of 3.89 ± 0.52 vessels incorporated per patient. Any iliac conduit was required in 35 patients (7.5%), including 24 patients (10.4%) treated between 2013 and 2017 and 11 (4.7%) who had procedures between 2018 and 2021 (P = .019). Nineteen patients had permanent conduits using iliofemoral bypass, 11 had temporary iliac conduits, and 5 had endoconduits. Iliofemoral conduits were necessary in 12% of patients with extent I to III TAAA, in 6% with extent IV TAAA, and in 3% with CAAA (P = .009). The use of iliofemoral conduit was more frequent among women (74% vs 27%; P < .001) and in patients with chronic obstructive pulmonary disease (49% vs 28%; P = .013), peripheral artery disease (31% vs 15%; P = .009), and American Society of Anesthesiologists classification of III or higher (74% vs 51%; P = .009). There were no inadvertent iliac artery disruptions in the entire study. The 30-day mortality and MAE were 1% and 19%, respectively, for all patients. An iliofemoral conduit using retroperitoneal exposure during the index FB-EVAR was associated with longer operative time (322 ± 97 minutes vs 323 ± 110 minutes vs 215 ± 90 minutes; P < .001), higher estimated blood loss (425 ± 620 mL vs 580 ± 1050 mL vs 250 ± 400 mL; P < .001), and rate of red blood transfusion (92% vs 78% vs 32%; P < .001) and lower technical success (83% vs 87% vs 98%; P < .001), but no difference in intraoperative access complications and MAEs, compared with iliofemoral conduits without retroperitoneal exposure during the index FB-EVAR and control patients who had FB-EVAR without iliofemoral conduits, respectively. There were no differences in mortality or in other specific MAE among the three groups. CONCLUSIONS: FB-EVAR with selective use of iliofemoral conduits was safe with low mortality and no occurrence of inadvertent iliac artery disruption or conversion. A staged approach is associated with shorter operating time, less blood loss, and lower transfusion requirements in the index procedure.

Outcomes of fenestrated-branched endovascular aortic repair in patients with or without prior history of abdominal endovascular or open surgical repair.

OBJECTIVE: The aim of this study was to compare outcomes of fenestrated-branched endovascular aortic repair (FB-EVAR) of complex abdominal (CAAAs) and thoracoabdominal aortic aneurysms (TAAAs) in patients with or without prior history of abdominal open surgical (OSR) or endovascular aortic repair (EVAR). METHODS: The clinical data of consecutive patients enrolled in a prospective, non-randomized study to evaluate FB-EVAR for treatment of CAAAs and TAAAs was reviewed. Clinical outcomes were analyzed in patients with no previous aortic repair (Controls), prior EVAR (Group 1), and prior abdominal OSR (Group 2), including 30-day mortality and major adverse events (MAEs), patient survival and freedom from aortic-related mortality (ARM), secondary interventions, any type II endoleak, sac enlargement (≥5 mm), and new-onset permanent dialysis. RESULTS: There were 506 patients (69% male; mean age, 72 ± 9 years) treated by FB-EVAR, including 380 controls, 54 patients in Group 1 (EVAR), and 72 patients in Group 2 (abdominal OSR). FB-EVAR was performed on average 7 ± 4 and 12 ± 6 years after the index EVAR and abdominal OSR, respectively (P < .001). All three groups had similar clinical characteristics, except for less coronary artery disease in controls and more TAAAs and branch stent graft designs in Group 2 (P < .05). Aneurysm extent was CAAA in 144 patients (28%) and TAAA in 362 patients (72%). Overall technical success, mortality, and MAE rate were 96%, 1%, and 14%, respectively, with no difference between groups. Mean follow up was 30 ± 21 months. Patient survival was significantly lower in Group 2 (P = .03), but there was no difference in freedom from ARM and secondary interventions at 5 years between groups. Group 1 patients had lower freedom from any type II endoleak (P = .02) and sac enlargement (P < .001), whereas Group 2 patients had lower freedom from new-onset permanent dialysis (P = .03). CONCLUSIONS: FB-EVAR was performed with high technical success, low mortality, and similar risk of MAEs, regardless of prior history of abdominal aortic repair. Patient survival was significantly lower in patients who had previous abdominal OSR, but freedom from ARM and secondary interventions were similar among groups. Patients with prior EVAR had lower freedom from type II endoleak and sac enlargement. Patients with prior OSR had lower freedom from new-onset dialysis.

Effects of Iliac Tortuosity Index on Fenestrated Endovascular Aortic Aneurysm Repair for Pararenal and Thoracoabdominal Aortic Aneurysms.

PURPOSE: To evaluate the effect of iliac tortuosity on procedural metrics and outcomes of patients with complex aortic aneurysms (cAAs) undergoing repair with fenestrated/branched endografts (f/b-EVAR [endovascular aortic aneurysm repair]). MATERIAL AND METHODS: The study is a single-center, retrospective review of a prospectively maintained database of patients undergoing aneurysm repair using f/b-EVAR between the years 2013 and 2020 at our institution. Included patients had at least 1 preoperative computed tomography angiography (CTA) available for analysis. Iliac artery tortuosity index (TI) was calculated using centerline of flow imaging from a 3-dimensional work station based on the formula: (centerline iliac artery length / straight-line iliac artery length). The associations between iliac artery tortuosity and procedural metrics, including total operative time, fluoroscopy time, radiation dose, contrast volume, and estimated blood loss (EBL), were evaluated. RESULTS: During this period, 219 patients with cAAs underwent f/b-EVAR at our institution. Ninety-one patients (74% men; mean age = 75.2±7.7 years) met criteria for inclusion into the study. In this group, there were 72 (79%) juxtarenal or paravisceral aneurysms and 18 (20%) thoracoabdominal aortic aneurysms and 5 patients (5.4%) with failed previous EVAR. The average aneurysm diameter was 60.1±0.74 mm. Overall, 270 vessels were targeted, and 267 (99%) were successfully incorporated, including 25 celiac arteries, 67 superior mesenteric arteries, and 175 renal arteries. The mean total operative time was 236±83 minutes, fluoroscopy time was 87±39 minutes, contrast volume was 81±47 mL, radiation dose 3246±2207 mGy, and EBL was 290±409 mL. The average left and right TIs for all patients were 1.5±0.3 and 1.4±0.3, respectively. On multivariable analysis, the interval estimates suggest positive association between TI and procedural metrics to a certain degree. CONCLUSIONS: In the current series, we found no definitive association between iliac artery TI and procedural metrics, including operative time, contrast used, EBL, fluoroscopy time, and dose in patients undergoing cAA repair using f/b-EVAR. However, there was a trend toward association between TI and all these metrics on multivariable analysis. This potential association needs to be evaluated in a larger series. CLINICAL IMPACT: Iliac artery tortuosity should not exclude patients with complex aortic aneurysms from being offered fenestrated or branched stent graft repair. However, special considerations should be taken to mitigate the impact of access tortuosity on alignment of fenestrations with target vessels, including use of extra stiff wires, through and through access and delivering the fenestrated/branched device into another (larger) sheath such as a Gore DrySeal in patients with arteries large enough to accommodate such sheaths.

Technical Pitfalls for Fenestrated-Branched Endovascular Aortic Repair Following PETTICOAT.

PURPOSE: The Provisional Extension to Induce Complete Attachment Technique (PETTICOAT) uses a bare-metal stent to scaffold the true lumen in patients with acute or subacute aortic dissections. While it is designed to facilitate remodeling, some patients with chronic post-dissection thoracoabdominal aortic aneurysms (TAAAs) require repair. This study describes the technical pitfalls of fenestrated-branched endovascular aortic repair (FB-EVAR) in patients who underwent prior PETTICOAT repair. TECHNIQUE: We report 3 patients with extent II TAAAs who had prior bare-metal dissection stents treated by FB-EVAR. Two patients required maneuvers to reroute the aortic guidewire, which was initially placed in-between stent struts. This was recognized before the deployment of the fenestrated-branched device. A third patient had difficult advancement of the celiac bridging stent due to a conflict of the tip of the stent delivery system into one of the stent struts, requiring to redo catheterization and pre-stenting with a balloon-expandable stent. There were no mortalities and target-related events after a follow-up of 12 to 27 months. CONCLUSION: FB-EVAR following the PETTICOAT is infrequent, but technical difficulties should be recognized to prevent complications from the inadvertent deployment of the fenestrated-branched stent-graft component in-between stent struts. CLINICAL IMPACT: The present study highlights a few maneuvers to prevent or overcome possible complications during endovascular repair of chronic post-dissection thoracoabdominal aortic aneurysm following PETTICOAT. The main problem to be recognized is the placement of the aortic wire beyond one of the struts of the existing bare-metal stent. Moreover, encroachment of catheters or the bridging stent delivery system into the stent struts may potentially cause difficulties.

Effects of SGLT2 inhibitors and GLP1-receptor agonists on cardiovascular and limb events in peripheral artery disease: A review.

Peripheral artery disease (PAD) and diabetes mellitus are two overwhelming health problems associated with major cardiovascular (CV) and limb events, in addition to increased mortality, despite advances in medical therapies including statins and renin-angiotensin system inhibitors. Sodium-glucose cotransporter 2 inhibitors (SGLT2i) and glucagon-like peptide 1-receptor agonists (GLP1-RA) are two new antihyperglycemic drug classes that have been associated with a significant reduction of major adverse cardiovascular events (MACE) in patients with type 2 diabetes (T2D) and CV risk. Whereas most studies had enrolled patients with T2D and concurrent CV disease (CVD), patients with PAD were obviously underrepresented. Furthermore, there was a signal of increased risk of amputation in one of the main trials with canagliflozin. We aim to provide a general review of the current literature and summarize societal guideline recommendations addressing the role of SGLT2i and GLP1-RA drugs in patients with CVD focusing on the PAD population when data are available. Endpoints of interest were MACE and, when available, major adverse limb events (MALE).

Transcarotid revascularization in obese patients.

OBJECTIVE: Transcarotid revascularization (TCAR) is a minimally invasive hybrid surgical carotid stenting technique which utilizes cerebral flow reversal as embolic protection during carotid lesion manipulation. This investigation was performed to define the perioperative risks associated with this operation in the obese patient. METHODS: A retrospective review of tandem carotid revascularization databases maintained at two high-volume health systems was performed to capture all TCARs performed between 2015 and 2022. A threshold of body mass index of 35 kg/m2 defined the "obese" patient. Demographics, intraoperative, perioperative, and follow-up characteristics were compared using univariate analysis. RESULTS: We performed 793 TCAR procedures that qualified for study inclusion within the prespecified time. After applying our obesity definition, 129 patients qualified as obese and were compared to the remainder. There were no significant differences in baseline demographics as comparable Charlson Comorbidity Indices were noted between groups; however, obese patients had a significantly higher prevalence of hypertension, hyperlipidemia, and diabetes. Intraoperative, case complexity in the obese patients did not seem to be increased, as measured by operative time (68.4 ± 23.0 vs 64.2 ± 25.8 min, p = 0.09), fluoroscopic time (4.9 ± 3.2 vs 4.6 ± 3.6 min, p = 0.38), and estimated blood loss (40.6 ± 49.0 vs 46.6 ± 49.4 min, p = 0.22). Similarly, no disparities were observed with respect to ipsilateral stroke (3.1 vs. 1.7%, p = 0.29), contralateral stroke (0 vs. 0.2%, p > 0.99), death (0 vs. 1.1%, p = 0.61), and stroke/death (3.1 vs. 3.0%, p > 0.99) in the 30-day perioperative period. Both cohorts were followed for approximately 1 year (12.0 ± 13.4 vs 11.6 ± 13.4 months, p = 0.76). During this period, rates of ipsilateral stroke (3.1% vs. 2.7%, p > 0.99), contralateral stroke (1.1 vs. 0.8%, p > 0.99), and death (4.7 vs. 6.2%, p = 0.68) were similar. CONCLUSIONS: TCAR performed in the obese population was not more challenging by intraoperative characteristics and did not result in a statistically higher incidence of adverse events in the perioperative phase.

Impact of a multidisciplinary acute aortic dissection program: Improved outcomes with a comprehensive initial surgical repair strategy.

OBJECTIVE: As part of a multidisciplinary aortic dissection (AD) program, a more comprehensive repair strategy for patients with acute type A aortic dissection (ATAAD) and frequent endografting for suitable patients with type B aortic dissection (ATBAD) was adopted in 2015. The aim of this study was to evaluate the impact of these changes. METHODS: This study is a retrospective review of a prospective database containing all patients treated for acute AD between 2003 and 2020. Patients were grouped based on differing repair strategies (pre 2015 vs post 2015). Clinical characteristics, procedural details, and survival data were analyzed. RESULTS: During this time, 323 patients (210 pre, 113 post) were treated for acute AD at our institution. There were 221 patients with ATAAD (149 pre, 72 post) and 102 patients with ATBAD (61 pre, 41 post). The majority (60%) were males, with a mean age of 65.9 ± 15.2 years. There were no differences in cardiovascular risk factors or demographics between the groups. After 2015, fewer patients with ATAAD underwent medical management alone (15% pre vs 4% post; P = .014), and most that underwent surgical intervention had a total arch or aggressive hemiarch repair (27% pre vs 78% post; P < .001). Seventy-four patients (73%) with ATBAD were treated medically, whereas 28 underwent medical management and endografting (23% pre, 34% post; P = .214). For all patients with AD, 30-day mortality was significantly improved (26% pre vs 10% post; P < .001) especially among patients who underwent ATAAD surgery (23% pre vs 9% post; P = .018). Three-year Kaplan-Meier survival estimates showed survival improvement among patients with ATAAD (Log rank P-value = .019); however, this improvement does not extend to type B dissections or the overall cohort. A survival analysis landmarked to 30 days after initial presentation showed no statistical difference in survival from 30 days to 3 years post-presentation. CONCLUSIONS: A more comprehensive repair strategy in the management of patients with acute AD resulted in improved overall patient outcomes and significantly decreased 30-day mortality, even though more complex repairs were performed. The long-term impact of the changes made to our program remains to be evaluated.

Outcomes of low- and standard-profile fenestrated and branched stent grafts for treatment of complex abdominal and thoracoabdominal aortic aneurysms.

OBJECTIVE: We compared the outcomes of fenestrated-branched (FB) endovascular abdominal aortic aneurysm repair (EVAR) using low-profile (LP) and standard-profile (SP) stent grafts for the treatment of complex abdominal aortic aneurysms (CAAAs) and thoracoabdominal aortic aneurysms (TAAAs). METHODS: We reviewed the clinical data of 466 consecutive patients (70% male; mean age, 74 ± 8 years) enrolled in a prospective nonrandomized study to investigate FB-EVAR for the treatment of CAAAs and TAAAs (2013-2021). The endpoints compared between the patients treated with LP (18F-20F) and SP (20F-22F) devices included procedural metrics, access-related complications, major adverse events (MAE), patient survival, freedom from secondary intervention, thromboembolic events, stent graft integrity issues, aneurysm sac enlargement, and the rate of sac shrinkage. RESULTS: Of the 466 aneurysms treated by FB-EVAR, 138 were CAAAs and 141 were extent IV and 187 extent I to III TAAAs, with a mean number of 3.9 ± 0.5 vessels stented per patient. LP devices had been used in 239 patients (51%) and SP devices in 227 patients (49%). LP devices had been used more frequently for chronic dissections (12% vs 7%; P = .041) and with preloaded systems (77% vs 65%; P = .005) and bilateral percutaneous femoral access (83% vs 74%; P = .020) and less frequently with upper extremity access (67% vs 88%; P < .001) and iliac conduits (2% vs 6%; P = .020). The patients treated using LP devices had experienced similar technical success (96% vs 97%; P = .527), with a shorter total operating time (225 ± 81 minutes vs 243 ± 78 minutes; P = .018), lower radiation exposure (median, 0.93 Gy; interquartile range [IQR], 0.94; vs median, 1.01 Gy; IQR, 0.91 Gy; P < .001), and less use of contrast (median, 135 mL; IQR, 68 mL; vs median, 144 mL; IQR, 80 mL; P = .008). No differences were found in the rates of iliofemoral access complications between the LP and SP device groups (1.3% vs 3.5%; P = .107). At 30 days, 5 patients had died (1%) and MAEs had occurred in 89 patients (19%), with no differences between the two groups. The mean follow-up was 28 months (95% confidence interval, 25-30 months). At 4 years, the patients treated with LP devices had had similar freedom from all-cause mortality (69% ± 6% vs 68% ± 4%; P = .199), freedom from aortic-related mortality (97% ± 1% vs 98% ± 1%; P = .488), freedom from any secondary intervention (65% ± 6% vs 70% ± 4%; P = .433), freedom from thromboembolic events (98% ± 1% vs 99% ± 1%; P = .364) and aneurysm sac enlargement (93% ± 3% vs 91% ± 3%; P = .293). However, the LP group had had less freedom from any integrity-related issues (92% ± 5% vs 100%; P < .001). The cumulative risk of sac shrinkage was greater for patients treated with LP devices (adjusted hazard ratio, 2.040; 95% confidence interval, 1.516-2.744; P < .001). CONCLUSIONS: FB-EVAR was performed with low rates of mortality and MAEs, irrespective of the device profile. However, the procedures performed with LP devices had had less need for iliac conduits and had had better procedural metrics. The use of LP devices resulted in higher rates of sac shrinkage. However, the results on stent graft integrity require future investigation.

Adverse events are not increased with trainee participation in transcarotid revascularization.

OBJECTIVE: To determine whether a vascular surgery trainee's participation in transcarotid revascularization (TCAR), a new technology, affects patient safety and outcomes. DESIGN: Retrospective, institutional review of our carotid database was performed. Patients who underwent TCAR were stratified based on whether a vascular trainee was present during the procedure. Relevant demographics, comorbidities, anatomical indication, perioperative courses, and adverse events in the postoperative period were captured for statistical analysis. SETTING: Data were obtained from affiliated Memorial Hermann Hospitals in Houston, Texas. PARTICIPANTS: All patients who underwent TCAR from September 2017 to January 2022 were included. RESULTS: Of 486 patients who underwent TCAR, 173 (35.6%) were performed in the presence of a trainee, and 313 (64.4%) were performed without a trainee. Subjects in the trainee cohort had more challenging anatomy, defined as a higher rate of carotid bifurcation above C2, restenotic disease, previous ipsilateral neck dissection, and neck radiation. The trainee cohort had higher rates of estimated blood loss (61.1 ± 66 vs. 35.5 ± 39 mL, p < 0.01), longer operative time (64.8 ± 30.3 vs. 57.9 ± 20.4 min, p < .01), longer cerebral blood flow reversal time (8.9 ± 6.1 vs. 7.9 ± 6.6 min, p = .01), and higher contrast administration (25.7 ± 12.0 vs. 21.1 ± 9.4 mL, p < .01). The ability to achieve technical success was similar between the two cohorts. There was no difference in the rates of cranial nerve palsy, ipsilateral stroke, hematoma, and stent thrombosis. Hospital length of stay, death (0% vs. 1.6%, p = .10), and stroke (1.1% vs. 2.8%, p = .22) were also similar between the two cohorts. CONCLUSION: Vascular surgery trainee's involvement during TCAR did not increase adverse outcomes, such as stroke and death, in the perioperative period. The results presented herein should encourage other teaching institutions to provide surgical trainees with supervised, hands-on experience during TCAR.

Endovascular management of left ventricular assist device outflow graft stenosis.

Stenosis of left ventricular assist devices has traditionally required open operative management with device revision or replacement; however, endovascular therapy is emerging as an alternative to open surgery. Limited by the rarity of this approach, consensus is lacking regarding the optimal technique. In this publication, we present a case report of outflow graft stenosis managed with endovascular treatment and discuss technical considerations including preoperative planning, stent selection, and procedural adjuncts.

Technical approach, outcomes, and exposure-related complications in patients undergoing anterior lumbar interbody fusion.

OBJECTIVE: To describe our technique, evaluate access related complications and factors contributing to adverse outcomes in patients undergoing retroperitoneal anterior lumbar interbody fusion (ALIF). METHODS: We conducted a retrospective analysis of prospectively collected data on patients undergoing ALIF at our institution from January 2008 to December 2017. Access was performed by a vascular surgeon who remained present for the duration of the case. Data collected included patients' demographics, comorbidities, exposure related complications and ileus. Study end points included major adverse events and minor complications. Major adverse events included any vascular injuries requiring repair, bowel and ureter injuries, postoperative bleeding requiring reoperation, myocardial infarction, stroke, venous thromboembolism (pulmonary embolism/deep venous thrombosis), wound dehiscence, and death. Minor complications included postoperative paralytic ileus, urinary tract infections, and surgical site infections. The incidence of incisional hernia was also evaluated. RESULTS: During this period, 1178 patients (514 males and 664 females; mean age, 54.1 ± 13.8 years) underwent a total of 2352 levels ALIF at our institution (single level, 422 patients; 2 levels, 450; 3 levels, 205; 4 levels, 98; 5 levels, 6; 6 levels, 1; and 7 levels, 1). The median estimated blood loss was 25 mL (interquartile range, 25-50). There were 57 exposure-related complications (4.8%), including vascular injuries (venous, 13; arterial, 4) in 17 patients (1.4%), bowel injuries in three patients (serosa tear in two and arterial embolization with subsequent bowel ischemia in one). Eleven of the 13 venous injuries (84.6%) occurred while exposing the L4 to L5 lumbar level. Two of the four patients with arterial injuries developed acute limb ischemia requiring embolectomy. One embolized to the superior mesenteric artery and underwent bowel resection. Twenty patients (1.7%) developed venous thromboembolism, two of whom had sustained left iliac vein injury during exposure. Sixteen patients (1.4%) developed a retroperitoneal hematoma/seroma with nine requiring evacuation in the operating room. Thirty-six patients (3.1%) developed postoperative ileus, defined as an inability to tolerate diet on postoperative day 3. Four patients (0.4%) had a postoperative myocardial infarction, and two had a stroke and two (0.17%) died within the first 30 postoperative days. Thirty-one patients developed incisional complications, including surgical site infection in 24 and incisional hernia in 7. CONCLUSIONS: Our findings suggest that ALIF exposure can be performed safely with a relatively low overall complication rate. The majority of vascular injuries associated with this procedure are venous in nature, occurring predominantly while exposing the L4 to L5 level and can be safely addressed by an experienced vascular team.

Comparison of Cerebral Embolic Events Between Right and Left Upper Extremity Access During Fenestrated/Branched Endovascular Aortic Repair.

PURPOSE: To evaluate the incidence and outcomes of cerebral embolic events when using right (RUE) vs left upper extremity (LUE) access for fenestrated/branched endovascular aneurysm repair (f/bEVAR). MATERIALS AND METHODS: A retrospective review was conducted of 290 consecutive patients enrolled in a physician-sponsored Investigational Device Exemption study to evaluate f/bEVAR between 2013 and 2018. Of these, 270 patients (93%) had an upper extremity access with 12-F sheaths, including 205 patients (mean age 75±8 years; 147 men) with LUE and 65 patients (mean age 73±8 years; 42 men) with RUE access. Outcome measures were technical success, procedural metrics, major adverse events (MAEs), any stroke or transient ischemic attack (TIA), and mortality. RESULTS: Technical success was higher (p=0.04) for LUE (99.6%) vs RUE access (98.4%). Patients treated via RUE access more often had extent I-III thoracoabdominal aortic aneurysms (57% vs 39%, p=0.03). Procedural metrics were similar for LUE vs RUE sides, including endovascular time (255±80 vs 246±83 minutes, respectively; p=0.23), fluoroscopy time (84±32 vs 90±35 minutes, respectively; p=0.80), and contrast volume (156±57 vs 153±56 mL, respectively; p=0.82). Total radiation exposure was significantly higher for LUE vs RUE access (2463±1912 vs 1757±1494 mGy, respectively; p=0.02). There were 2 deaths (1%) at 30 days or during hospital admission, both unrelated to access site complications. MAEs occurred in 32% of patients who had LUE and 26% of those who had RUE access (p=0.44). Five patients (2%) had embolic stroke and none had TIA. Embolic strokes were ipsilateral to the access side in 4 patients and affected the posterior circulation in 3. Two patients (1%) had hemorrhagic strokes. The incidence of stroke was 3% for LUE and 2% for RUE access (p>0.99). CONCLUSION: Fenestrated/branched stent-graft repair was associated with low rates of cerebral embolic events and no significant difference between the right vs left upper extremity approach.

Lipid-lowering therapies in peripheral artery disease: A review.

Peripheral artery disease (PAD) is estimated to affect approximately 8.5 million individuals in the US above the age of 40, and is associated with significant morbidity, mortality, and impairment. Despite the significant adverse limb and cardiovascular (CV) outcomes seen in patients with PAD, there is typically less attention paid to risk factor modification relative to other atherosclerotic diseases such as coronary artery disease (CAD) or stroke. In the current literature, statins have been shown to reduce mortality, major adverse CV events, major adverse limb events, and improve symptomatic outcomes in patients with PAD. In addition, proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors are emerging as an additional lipid-lowering therapy for patients with PAD. However, despite current guideline recommendations based on growing evidence, patients with PAD are consistently undertreated with lipid-lowering therapies. We provide an extensive literature review and evidence-based recommendations for the use of statins and PCSK9 inhibitors in patients with PAD.

Risk and Management of Venous Thromboembolism in Patients with COVID-19.

BACKGROUND: One of the most pronounced and poorly understood pathological features of COVID-19 infection has been high risk for venous and arterial thromboembolic complications. An increasing number of thromboembolic events are being reported almost on a daily basis, and the medical community has struggled to predict and mitigate this risk. We aimed to review available literature on the risk and management of COVID-19 related venous thromboembolism (VTE), and provide evidence-based guidance to manage these events. METHODS: A literature review of VTE complications in patients with COVID-19 was performed, in addition to a summary of the societal guidelines and present pathways implemented at our institution for the management of both in- and outpatient COVID-19 related VTE. RESULTS: Although a significant VTE risk has been confirmed in patients with COVID-19, literature addressing best ways to mitigate this risk is lacking. Furthermore, there has been very limited guidance provided by societal guidelines to help prevent and manage VTE associated with the COVID-19 infection. In light of the available data, we advise that all patients admitted with suspected or confirmed COVID-19 receive pharmacological prophylaxis if bleeding risk is acceptable. For patients with COVID-19 who have been discharged from the emergency department or hospital, we suggest extended thromboprophylaxis (up to 39 days) as long as bleeding risk is low. CONCLUSIONS: We believe that this literature summary along with our center recommendations and algorithms provide valuable guidance to providers caring for patients with COVID-19 related VTE. More research is needed to standardize prophylaxis and management protocols for these patients.

Determining Risk Factors for Endovenous Heat-induced Thrombosis after Radiofrequency Ablation.

BACKGROUND: The objective of this study was to evaluate risk factors, incidence, management, and outcome of endovenous heat-induced thrombosis (EHIT) related to radiofrequency ablation (RFA). METHODS: This was a single-center retrospective analysis of patients over the age of 18 who underwent RFA between 2016 and 2019. Demographics, comorbidities, medications, severity scores, vascular anatomy, procedural details, and outcome data were collected. EHIT-related data included occurrence, grade, laterality, management, and outcome. RESULTS: During the study period, 672 RFA procedures were performed at our institution. Of these, 642 (median age 57 (21-93), 62.3% female) met study inclusion criteria. EHIT was observed in 43 (6.6%) cases. Concurrent left common femoral vein (CFV) or right femoral vein (FV) incompetence was found to be more prevalent in the EHIT group (P = 0.024 and P = 0.011, respectively). Compared with performing RFA alone, concurrent performance of stab phlebectomy and sclerotherapy with RFA on the left side was found to be associated with possible increased risk for EHIT (P = 0.021). Furthermore, patients with diabetes mellitus (DM) (P = 0.05) and those with median diameter of the treated left vein of 1.2 cm (P = 0.02) were more likely to have a higher EHIT grade (III and IV) than those without DM and those with smaller vein diameter, respectively. Management included aspirin (44%), anticoagulant (28%), both (10%), or neither (18%). EHIT either resolved or regressed (64%), did not change (5%), or propagated (8%) at follow-up. CONCLUSIONS: Left CFV or right FV incompetence was found to be more prevalent in the total EHIT group. Furthermore, DM and the median size of the treated vein on the left (1.2 cm) were more prevalent in the high (III-IV) versus low grade (I-II) EHIT group. More than 50% of EHIT improved (regressed or resolved) at follow-up regardless of the management option. Further analysis with larger patient samples are needed to confirm the association between these variables and the development of EHIT.

Learning curve of fenestrated and branched endovascular aortic repair for pararenal and thoracoabdominal aneurysms.

OBJECTIVE: The objective of this study was to review the learning curve for fenestrated-branched endovascular aortic repair (F-BEVAR) of pararenal and thoracoabdominal aortic aneurysms (TAAAs). METHODS: We reviewed the clinical data of 334 consecutive patients (255 males, mean age 75 ± 7 years) who underwent F-BEVAR between 2007 and 2016 in a single institution. Outcomes were analyzed in four quartiles of experience (Q1-Q4). Study outcomes included trends in patient characteristics, device design, procedural variables, 30-day mortality, and major adverse events (MAEs). RESULTS: There were 178 patients (53%) treated for pararenal aneurysms and 156 (47%) for TAAAs. During the study period, there was a statistically significant increase in the proportion of TAAAs and in the number of vessels incorporated. Despite this, there was a steady decrease in 30-day mortality (6% in Q1 to 0% in Q4; P < .04) and in the rate of MAEs (60% in Q1 to 29% in Q4; P<.001). By linear regression analysis, there was significant decline in estimated blood loss (1358 ± 1517 mL in Q1 to 486 ± 520 mL in Q4; P < .001), total operating time (325 ± 116 minutes in Q1 to 248 ± 92 minutes in Q4; P < .001), total fluoroscopy time (121 ± 59 minutes in Q1 to 85 ± 39 minutes in Q4; P < .001), contrast volume (201 ± 92 mL in Q1 to 160 ± 61 mL in Q4; P = .002), and radiation dose (4141 ± 2570 mGy in Q2 to 2543 ± 1895 mGy in Q4; P < .001). Independent predictors of MAEs were total operating time (odds ratio [OR], 1.6; 95% confidence interval [CI], 1.3-1.8; P < .001), Society for Vascular Surgery total score (OR, 1.1; 95% CI, 1.02-1.2; P = .009), and quartile 1 (OR, 3.0; 95% CI, 1.7-5.2; P < .001). CONCLUSIONS: This study demonstrates significant improvement in perioperative mortality, MAEs, procedural variables, and secondary interventions in patients treated by F-BEVAR, despite the increase in complexity of aneurysm pathology during the study period. Also, better patient selection contributed to improve outcomes.