Safety and learning curve of percutaneous axillary artery access for complex endovascular aortic procedures.

BACKGROUND: Percutaneous axillary artery access is increasingly used for large-bore access during interventional vascular and cardiac procedures. The aim of this study was to evaluate the safety and learning curve of percutaneous axillary artery access in patients undergoing complex endovascular aortic repair (fenestrated and branched endovascular aneurysm repair [FBEVAR]) requiring large-bore upper extremity access and to discuss best practices for technique and complication management. METHODS: One-hundred forty-six patients undergoing large-bore percutaneous axillary artery access during FBEVAR in a prospective, nonrandomized, Investigational Device Exemption study between September 2017 and January 2023 were analyzed. Ultrasound guidance and micropuncture were used to access the second portion of the axillary artery and 2 Perclose Proglide or Prostyle devices (Abbott Vascular) were predeployed before the insertion of the large-bore sheath. Completion angiography was performed in all patients to verify hemostatic closure. Axillary artery patency was also assessed on follow-up computed tomography angiography. Patient-related, procedural, and postoperative variables were collected and analyzed. RESULTS: One-hundred forty-five patients underwent successful percutaneous axillary artery access; 1 patient failed axillary access and alternative access was established. The left axillary artery was accessed in 115 patients (79%), and the right axillary artery was accessed in 30 patients (21%). The largest profile sheath was 14 F in 4 patients (2.8%), 12F in 133 patients (91.7%), and 8F in 8 patients (5.5%). Ten patients (6.9%) required covered stent placement (Viabahn, W. L. Gore & Associates) for failure to achieve hemostasis; there were no conversions to open surgical repair. Additional adverse events included transient upper extremity weakness in two patients (1.3%) and transient upper extremity paresthesias in two patients (1.3%). Three patients (2%) suffered postoperative strokes, including one unrelated hemorrhagic stroke and two possibly access-related embolic strokes. On follow-up, axillary artery patency was 100%. There was a trend toward decreased closure failure over time, with seven patients (10%) in the early cohort and three (4%) in the late cohort. There was a significant negative correlation between the cumulative complication rate and the cumulative experience. CONCLUSIONS: Large-bore percutaneous axillary artery access provides safe upper extremity large-bore access during FBEVAR, achieving successful closure in >90% of patients with a low incidence of access-related complications. There was a trend toward better closure rates with increasing experience, suggesting a learning curve effect. Application of best practices including ultrasound guidance and angiography may ensure safe application of the technique of percutaneous large-bore axillary artery access.

Outcomes of Percutaneous Access to the First Versus Third Segment of Axillary Artery During Aortic Procedures.

PURPOSE: This article aims at investigating the outcomes of percutaneous access via the first versus third axillary artery (AXA) segments with closure devices during aortic procedures. MATERIALS AND METHODS: All patients receiving percutaneous AXA access closed with Perclose ProGlide device (Abbott, Santa Clara, California) from 2008 to 2021 were included in a retrospective multicenter registry (NCT: 04589962). Efficacy endpoint was the technically successful percutaneous procedure (no open conversion). Safety endpoints were stroke and access complications according to the Valve Academic Research Consortium-3 reporting standards. The first (AXA1) or third (AXA3) axillary puncture sites were compared. RESULTS: A total of 412 percutaneous AXA accesses were included: 172 (42%) in AXA1 and 240 (58%) in AXA3. Left AXA was catheterized in 363 cases (76% of AXA1 vs 97% of AXA3, p<0.001) and 91% of fenestrated/branched endovascular repair (F/BEVAR) procedures were conducted from the left. A ≥12F internal diameter (ID) sheath was used in 49% of procedures. Open conversion rate was 1%, no major vascular complications occurred, and only one major non-vascular complication was recorded. Primary closure failure occurred in 18 AXA1 (11%) and 32 AXA3 accesses (13%), treated by covered (8.3%) or bare-metal (2.7%) stenting. Bailout stent patency was 100% at median follow-up of 12 months, with 6 of 6 stents still patent after >36 months of follow-up. Stroke rate was 4.4%. An introducer sheath >12F was independently associated with both access complications (p<0.001) and stroke (p=0.005), while a right-side access was associated with stroke only (p=0.034). Even after adjustment for covariates, AXA1 versus AXA3 showed an equal success rate (odds ratio [OR]=0.537, 95% confidence interval [CI]=0.011-1.22 for AXA3, p=0.104). The combination of AXA3 and a >10F introducer sheath provided worse outcomes compared with >10F sheaths through AXA1 (OR for success=0.367, 95% CI=0.176-0.767, p=0.008). This was not confirmed for >12F sheaths, associated with similar outcomes (p=0.31 AXA 1 vs AXA 3). CONCLUSION: Major local complications with the percutaneous axillary approach and ≤12F sheaths are infrequent and solvable by complementary endovascular interventions. Stroke risk remains an issue. First and third AXA segments are both amenable for access with good results, but larger sheaths (12F) perform better in AXA1. CLINICAL IMPACT: Percutaneous access with vascular closure devices at the first or third axillary artery (AXA) segments during aortic procedures is burdened by a negligible risk of open conversion. Local complications with the percutaneous axillary approach are infrequent and solvable by complementary endovascular interventions. First and third AXA segments are both amenable to access with excellent results, but larger sheaths (12F) perform better in the wider first AXA segment. In this setting, bailout stenting does not appear to be associated with mid-term stent occlusion.

An Original Study: Is There an Optimal Time to Complete Dedicated Research During Surgical Residency? Twelve Years of Research Experience After PGY2 or PGY3.

OBJECTIVE: We aimed to determine if there is an optimal time to complete dedicated research during surgical residency. BACKGROUND: Research is an integral part of academic general surgical residency, and dedicated research usually occurs after the 2nd or 3rd post-graduate year (PGY). The timing of dedicated research and its association with resident productivity, self-assessed competency (including technical skills), and fellowship match is not known. METHODS: PubMed was queried for publications resulting after dedicated research time for graduating surgical residents at a single institution from 2010 to 2021. Graduates were surveyed about their research experience and placed into 2 groups: research after PGY2 or PGY3. RESULTS: Sixty-six of 91 (73%) graduating residents completed dedicated research (after PGY2, n=28; after PGY3, n=38). Median number of total and first author publications was similar between groups; however, research after PGY2 was associated with an increased number of basic science publications by fellowship application deadlines (PGY2: 1.0[0-13] vs PGY3: 0.0[0-6], p=0.02). With a 79% survey response rate, there were no differences in self-assessed competencies upon return from research between cohorts. Most surveyed residents matched at their top fellowship choice (PGY2:70% vs PGY3:62%, p=0.77). CONCLUSIONS: Research after PGY2 or PGY3 had no association with residents' total number of publications, self-assessed competency, or rates of matching at first choice fellowship. As research after PGY2 had an increased number of basic science publications by time of fellowship application, surgical residents applying to fellowships that highly value basic science research may benefit from completing dedicated research after PGY2.

Hemostatic Agents in Orthopedic Surgery.

Controlling blood loss is a crucial aspect of orthopedic surgery. Hemostatic agents can be used intraoperatively in combination with antifibrinolytics as part of an overall strategy to limit blood loss. Several new hemostatic agents have recently come to the market designed specifically for vascular surgery but have found uses in other surgical fields, including orthopedics. This article reviews the mechanisms of action and best uses of various mechanical hemostats, active hemostats, flowable hemostats, and fibrin sealants for achieving hemostasis in orthopedic surgery. Mechanical and active hemostats have been reported to successfully decrease blood loss from cancellous bone, capillaries, and venules. Flowable hemostats are generally favorable for use in small spaces where the swelling capabilities of mechanical and active hemostats can be detrimental to surrounding structures. Sealants are best used for closing defects in tissues.

Multicentre International Registry of Open Surgical Versus Percutaneous Upper Extremity Access During Endovascular Aortic Procedures.

OBJECTIVE: To investigate access failure (AF) and stroke rates of aortic procedures performed with upper extremity access (UEA), and compare results of open surgical vs. percutaneous UEA techniques with closure devices. METHODS: A physician initiated, multicentre, ambispective, observational registry (SUPERAXA - NCT04589962) was carried out of patients undergoing aortic procedures requiring UEA, including transcatheter aortic valve replacement, aortic arch, and thoraco-abdominal aortic endovascular repair, pararenal parallel grafts, renovisceral and iliac vessel repair. Only vascular procedures performed with an open surgical or percutaneous (with a suture mediated vessel closure device) UEA were analysed. Risk factors and endpoints were classified according to the Society for Vascular Surgery and VARC-3 (Valve Academic Research Consortium) reporting standards. A logistic regression model was used to identify AF and stroke risk predictors, and propensity matching was employed to compare the UEA closure techniques. RESULTS: Sixteen centres registered 1 098 patients (806 men [73.4%]; median age 74 years, interquartile range 69 - 79 years) undergoing vascular procedures using open surgical (76%) or percutaneous (24%) UEA. Overall AF and stroke rates were 6.8% and 3.0%, respectively. Independent predictors of AF by multivariable analysis included pacemaker ipsilateral to the access (odds ratio [OR] 3.8, 95% confidence interval [CI] 1.2 - 12.1; p = .026), branched and fenestrated procedure (OR 3.4, 95% CI 1.2 - 9.6; p = .019) and introducer internal diameter ≥ 14 F (OR 6.6, 95% CI 2.1 - 20.7; p = .001). Stroke was associated with female sex (OR 3.4, 95% CI 1.3 - 9.0; p = .013), vessel diameter > 7 mm (OR 3.9, 95% CI 1.1 - 13.8; p = .037), and aortic arch procedure (OR 7.3, 95% CI 1.7 - 31.1; p = .007). After 1:1 propensity matching, there was no difference between open surgical and percutaneous cohorts. However, a statistically significantly higher number of adjunctive endovascular procedures was recorded in the percutaneous cohort (p < .001). CONCLUSION: AF and stroke rates during complex aortic procedures employing UEA are non-negligible. Therefore, selective use of UEA is warranted. Percutaneous access with vessel closure devices is associated with similar complication rates, but more adjunctive endovascular procedures are required to avoid surgical exposure.

Expression of the mono-ADP-ribosyltransferase ART1 by tumor cells mediates immune resistance in non-small cell lung cancer.

Most patients with non-small cell lung cancer (NSCLC) do not achieve durable clinical responses from immune checkpoint inhibitors, suggesting the existence of additional resistance mechanisms. Nicotinamide adenine dinucleotide (NAD)-induced cell death (NICD) of P2X7 receptor (P2X7R)-expressing T cells regulates immune homeostasis in inflamed tissues. This process is mediated by mono-adenosine 5'-diphosphate (ADP)-ribosyltransferases (ARTs). We found an association between membranous expression of ART1 on tumor cells and reduced CD8 T cell infiltration. Specifically, we observed a reduction in the P2X7R+ CD8 T cell subset in human lung adenocarcinomas. In vitro, P2X7R+ CD8 T cells were susceptible to ART1-mediated ADP-ribosylation and NICD, which was exacerbated upon blockade of the NAD+-degrading ADP-ribosyl cyclase CD38. Last, in murine NSCLC and melanoma models, we demonstrate that genetic and antibody-mediated ART1 inhibition slowed tumor growth in a CD8 T cell-dependent manner. This was associated with increased infiltration of activated P2X7R+CD8 T cells into tumors. In conclusion, we describe ART1-mediated NICD as a mechanism of immune resistance in NSCLC and provide preclinical evidence that antibody-mediated targeting of ART1 can improve tumor control, supporting pursuit of this approach in clinical studies.

Ipsilateral Iliac Branch Repair Using a Looped Wire, Precannulated Gate Technique.

PURPOSE: To describe a novel, entirely ipsilateral femoral technique for distal endograft extension using the Gore Iliac Branch Endoprosthesis. TECHNIQUE: Femoral arterial access is obtained on the side of the intended repair, and a 16F sheath is inserted over a stiff wire. A looped wire is used to pre-cannulate the internal gate of the IBE device prior to insertion, and the device is then positioned and deployed. This through-wire guides access over the IBE flow divider and into the internal gate with a steerable sheath. The internal iliac artery is then selected, and a Viabahn VBX balloon-expandable stent (W.L. Gore, Flagstaff, AZ) is advanced into position and deployed. We present the successful completion of this technique in 4 patients. CONCLUSION: This novel technique allows distal endograft extension with an IBE device using only ipsilateral femoral access and is particularly useful for patients with aneurysmal iliac degeneration in the setting of prior open or endovascular aneurysm repair. This eliminates the need for upper extremity access or contralateral femoral access and navigation across the steep flow divider.

Risk factors for spinal cord injury and complications of cerebrospinal fluid drainage in patients undergoing fenestrated and branched endovascular aneurysm repair.

OBJECTIVE: Spinal cord injury (SCI) is one of the most devastating complications of thoracoabdominal aortic aneurysm (TAAA) repair. Cerebrospinal fluid drainage (CSFD) is routinely used to prevent and to treat SCI during open TAAA repair. However, the risks and benefits of CSFD during fenestrated-branched endovascular aneurysm repair (F/B-EVAR) are unclear. This study aimed to determine the risk of SCI after F/B-EVAR and to assess the risks and benefits of CSFD. METHODS: We analyzed 106 consecutive patients with TAAAs treated with F/B-EVAR from 2014 to 2019 in a prospective physician-sponsored investigational device exemption study (G130193). Data were collected prospectively and audited by an independent external monitor. All patients were treated with Cook manufactured patient-specific F/B-EVAR devices or the Cook t-Branch devices (Cook Medical, Bloomington, Ind). CSFD was used at the discretion of the principal investigator. Risk factors for SCI were identified, and CSFD complications were assessed. RESULTS: Prophylactic CSFD was used in 78 patients (73.6%), and 28 patients (26.4%) underwent F/B-EVAR without CSFD. Four patients (3.8%) with prophylactic CSFD developed SCI, including two patients (1.9%) with permanent paraplegia (Tarlov grade 1-2) and two patients (1.9%) with paraparesis (Tarlov grade 3). Multivariate analysis revealed that greater extent of thoracic aortic coverage (odds ratio, 1.06; 95% confidence interval, 1.00-1.11; P = .02) and intraoperative blood loss (odds ratio, 1.00; 95% confidence interval, 1.00-1.002; P = .04) were the significant risk factors for SCI. Six patients (7.6% [6/78]) experienced major CSFD-related complications, including subarachnoid hemorrhage in 2.6% (2), spinal hematoma in 2.6% (2), cerebellar hemorrhage in 1.3% (1), and spinal drain fracture requiring surgical laminectomy in 1.3% (1). Minor CSFD-related complications occurred in 20 patients (25.6% [20/78]), including paresthesia during CSFD insertion (10), minimal bloody cerebrospinal fluid (7), drain malfunction (2), and reflex hypotension (1). Technical difficulties during CSFD catheter placement were noted in seven patients (9.0%). Excluding four patients with SCI, intensive care unit stay was 3.3 ± 4.0 days in the CSFD group vs 1.2 ± 0.9 days in the no-CSFD group (P = .007). Total hospital length of stay was 6.0 ± 4.9 days in the CSFD group vs 3.5 ± 1.9 days in the no-CSFD group (P = .01). CONCLUSIONS: The incidence of SCI after F/B-EVAR with selective CSFD was low, and risk factors for SCI were greater with extent of thoracic aortic coverage and intraoperative blood loss. However, the incidence of major CSFD-related complications exceeded the incidence of SCI, and CSFD significantly increased both intensive care unit and total hospital length of stay. Therefore, routine prophylactic CSFD may not be justified, and a prospective randomized trial of CSFD in patients undergoing F/B-EVAR seems appropriate.

Carbon Dioxide Angiography in the Treatment of Transplant Renal Artery Stenosis.

BACKGROUND: Transplant renal artery stenosis (TRAS) is a serious complication associated with graft loss. Selective carbon dioxide angiography allows for effective diagnosis and therapy with the use of minimal to no contrast agent. This study sought to evaluate the efficacy of the adjunctive use of carbon dioxide angiography in the treatment of TRAS. METHODS: Patients undergoing endovascular therapy (percutaneous transluminal angioplasty with or without stent) for TRAS between the years 2012 and 2017 at a single tertiary care academic medical center were studied. Outcomes of interest included technical success, postoperative glomerular filtration rate, and renal ultrasound hemodynamic parameters. RESULTS: Of the 37 patients who underwent angiography for TRAS during the study period, 34 underwent a therapeutic intervention. Of those, 24 patients (70.6%) underwent adjunctive carbon dioxide angiography versus 10 patients (29.4%) who underwent standard contrast angiography. Baseline characteristics between the carbon dioxide angiography and traditional angiography groups were similar. Patients undergoing carbon dioxide angiography received significantly less contrast agent than patients undergoing traditional angiography [9.5 mL (IQR 2-19.5) versus 19.5 mL (IQR 15-30), P = 0.03)] and maintained equivalent technical success rates (92.2% vs. 91.7%, P = 0.9). CONCLUSIONS: The adjunctive use of carbon dioxide angiography allows for significantly less contrast administration compared with standard angiography while achieving an equivalent rate of technical success. Selective carbon dioxide angiography should be considered a first-line modality for patients with TRAS in need of endovascular therapy.

Safety and Effectiveness of Percutaneous Axillary Artery Access for Complex Aortic Interventions.

BACKGROUND: The aim of this study is to evaluate the safety and effectiveness of percutaneous axillary artery access in patients requiring upper extremity large sheath access during complex aortic interventions. METHODS: Consecutive patients who had percutaneous axillary artery access with a large-bore sheath during endovascular thoracoabdominal aortic artery aneurysm repair within an Food and Drug Administration-approved, physician-sponsored investigational device exemption study or visceral artery interventions during other complex aortic interventions were included in the study. All patients had percutaneous axillary artery ultrasound-guided access and deployment of 2 Perclose ProGlide devices (Abbott Vascular, Santa Clara, CA) prior to introduction of a large sheath. Completion angiography was performed to assess technical success of percutaneous access site closure, which was defined as hemostatic arterial closure without evidence of axillary artery stenosis or occlusion requiring intervention. Follow-up computed tomography scans and patient records were also reviewed for access site associated complications. RESULTS: A total of 46 patients underwent percutaneous axillary artery access. Largest sheath profile was 16F in 1 (2%), 12F in 42 (91%), 10F in 1 (2%), 9F in 1 (2%), and 8F in 1 (2%) patient. Technical success was achieved in 41 of 46 patients (89%). Five patients required endovascular covered stent placement during the index operation to control persistent access site bleeding. Two of 46 patients (4%) suffered access-related complications; both patients experienced ipsilateral upper extremity paresthesias without motor weakness, with persistent digit numbness in one. There was no incidence of conversion to open axillary artery repair and no additional access site complications (stenosis, occlusion, or dissection) but neurologic complications were observed during follow-up. CONCLUSIONS: Percutaneous axillary artery access can be used to provide upper extremity arterial access during complex aortic interventions with high rates of safety and technical success. Overall complication rates are low and occurred mainly during the early experience, indicating that there is an associated learning curve effect. Elimination of surgical cutdown incisions and arterial conduits by using percutaneous axillary access may reduce operative times and wound-related complications during complex aortic interventions requiring large-bore upper extremity access.

Analysis of the Learning Curve and Patient Outcomes of Endovascular Repair of Thoracoabdominal Aortic Aneurysms Using Fenestrated and Branched Stent Grafts: Prospective, Nonrandomized, Single-center Physician-sponsored Investigational Device Exemption Clinical Study.

OBJECTIVE: To evaluate the outcomes and learning curve of fenestrated and branched endovascular repair (F/BEVAR) of thoracoabdominal aneurysms. SUMMARY OF BACKGROUND DATA: Endovascular aneurysm repair has reduced morbidity and mortality compared with open surgical repair. However, application to thoracoabdominal aneurysm repair remains limited by procedural complexity and device availability. METHODS: Fifty patients treated in a prospective, nonrandomized, single-center Investigational Device Exemption (IDE) study between January 2014 and July 2017 were analyzed. Patients (mean age 75.6 ±â€Š7.5 years; mean aneurysm diameter 67.3 ±â€Š9.8 mm) underwent F/BEVAR of thoracoabdominal aneurysms (58% type IV; 42% type I-III) using custom-manufactured endografts. The experience was divided into 3 cohorts (Early: 1 to 17; Mid: 18 to 34; Late: 35 to 50) to evaluate learning curve effects on key process measures. RESULTS: F/BEVAR included 194 visceral arteries (average 3.9 per patient). Technical success was 99.5% (193/194 targeted arteries). Thirty-day major adverse events (MAEs) included 3 (6%) deaths, 1 (2%) new-onset dialysis, 3 (6%) paraparesis/paraplegia, and 2 (4%) strokes. One-year survival was 79 ±â€Š7%. Comparing the Early and Late groups revealed reductions in procedure time (452 ±â€Š74 vs 362 ±â€Š53 minutes; P = 0.0001), fluoroscopy time (130 ±â€Š40 vs 99 ±â€Š27 minutes; P = 0.016), contrast administration (157 ±â€Š73 vs 108 ±â€Š38 mL; P = 0.028), and estimated blood loss (EBL; 1003 ±â€Š933 vs 481 ±â€Š317 mL; P = 0.042). Intensive care unit (ICU) and total length of stay (LOS) decreased from 4 ±â€Š3 to 2 ±â€Š1 days and from 7 ±â€Š6 to 5 ±â€Š2 days, respectively, but was not statistically significant. CONCLUSIONS: Use of F/BEVAR for treatment of thoracoabdominal aneurysms is safe and effective. During this early experience, there was a significant improvement in key process measures reflecting improvements in technique and physician learning over time.

Safety and Effectiveness of a "Percutaneous-First" Approach to Endovascular Aortic Aneurysm Repair.

BACKGROUND: Percutaneous endovascular aneurysm repair (PEVAR) has been increasingly used in the endovascular treatment of abdominal aortic aneurysms. Furthermore, the percutaneous approach can be used with minimal sedation and local anesthesia in most cases. The purpose of this study was to assess the safety and effectiveness of a "percutaneous first" approach to femoral access for EVAR. METHOD: From 2012 to 2014, PEVAR has been the preferred approach to femoral access for EVAR at our institution. Retrospective review of institutional vascular quality initiative data was used to compare outcomes with elective PEVAR to a contemporary institutional series of elective EVAR via open femoral exposure. These 2 patient groups were compared with assess perioperative outcomes, procedural details (including anesthesia modality, procedure time, and length of stay [LOS]) and access-related complications between groups. RESULTS: One hundred two consecutive patients underwent attempted PEVAR and were compared with 98 patients undergoing surgical femoral exposure. Demographics and comorbidities were similar between groups, although there was a greater proportion of smokers in the PEVAR group (76.5% vs. 63.3%; P = 0.04). PEVAR was associated with an increased utilization of local anesthesia (67.6% vs. 12.2%; P < 0.001). PEVAR was associated with shorter postoperative LOS (mean 1.7 vs. 3.0 days; P = 0.035), shorter procedure times (137 vs. 222 min; P < 0.001), and significantly less blood loss (169 vs. 481 mL; P < 0.001). There were 5 access-site complications (4.9%) in the PEVAR group requiring conversion to open femoral exposure, compared with 2 patients (2.0%) with access-related complications after open femoral exposure (P = 0.09). There were significantly more hematomas in the PEVAR group (9.8% vs. 2.0%, P = 0.02). However, there were no significant differences in overall postoperative complications, wound infection, or ICU LOS. CONCLUSIONS: A "PEVAR first" approach proved feasible in the overwhelming majority of patients. Conversion to open transfemoral exposure was rare. PEVAR facilitated endovascular abdominal aortic aneurysm repair under local anesthesia in most patients and resulted in decreased procedural morbidity and resource utilization.