Ultrasound-Guided Percutaneous Cryoneurolysis for Perioperative Analgesia Following Major Lower Extremity Amputation: A Randomized, Participant- and Observer-Masked, Sham-Controlled Pilot Study.

BACKGROUND: Extremity amputations are associated with pain in both the residual limb and the phantom limb. This pain, which is often debilitating, may be prevented by excellent perioperative pain control. Ultrasound-guided percutaneous cryoneurolysis is an analgesic modality offering pain control for weeks or months following surgery. This treatment has not been compared to the sham procedure for large nerves (e.g., femoral and sciatic) to provide preoperative analgesia. We therefore conducted a randomized, controlled pilot study to evaluate the use of this modality for the treatment of pain following amputation to (1) determine the feasibility of and optimize the study protocol for a subsequent definitive clinical trial; and (2) estimate analgesia and opioid reduction within the first postoperative weeks. METHODS: A convenience sample of seven patients undergoing lower extremity amputation were randomized to receive either active cryoneurolysis or a sham procedure targeting the sciatic and femoral nerves in a participant-masked fashion. This was a pilot study with a relatively small number of participants, and therefore the resulting data were not analyzed statistically. RESULTS: Compared to the participants who received sham treatment (n=3), those who underwent active cryoneurolysis (n=4) reported lower pain scores and decreased opioid consumption at nearly all time points between days one and 21 following amputation. CONCLUSIONS: Ultrasound-guided percutaneous cryoneurolysis of the femoral and sciatic nerves prior to lower extremity amputation appears feasible and potentially effective. The data from this pilot study may be used to power a definitive randomized clinical trial.

Small Arteriovenous Anastomosis in Fistula Creation: Establishing a Functional Vascular Access while Minimizing Steal Syndrome.

BACKGROUND: The size selection of the arteriovenous (AV) anastomosis in dialysis access creation requires a careful balance: the diameter must be large enough to accommodate sufficient flow for hemodialysis but small enough to minimize the complication of steal syndrome. Steal syndrome affects up to 10% of patients after creation of dialysis access with sometimes devastating consequences. Conventional teaching recommends a 7-10 mm anastomosis. We sought to assess the efficacy of using a smaller (5-6 mm) anastomosis in new arteriovenous fistula (AVF) creation. METHODS: We conducted a comparative retrospective analysis of patients who underwent fistula creation with a small versus regular size anastomosis at any upper extremity anatomic site between March 2019 and October 2020 at our institution. Anatomic sites included radiocephalic, brachiocephalic, and brachiobasilic. All AV anastomoses were measured intraoperatively to be 5-6 mm in diameter for the small size groups and 8-10 mm for the regular size group. Endpoints included steal syndrome, functional patency, primary patency, and secondary patency. RESULTS: Out of 110 patients who underwent an AVF creation, 59.1% received a 5-6 mm anastomosis with a median follow-up time of 10 ± 6 months. Patients' demographics and comorbidities were relatively similar between the 2 groups except for a higher rate of hyperlipidemia (55.4% vs. 28.9%, P = 0.008) in the small size group. Patients in the small size group were more likely to undergo a radiocephalic fistula (40% vs. 4.5%, P < 0.001) and to have a smaller mean vein diameter on preoperative duplex ultrasound (3.2±1 mm vs. 3.9±1 mm, P = 0.0016) when compared to their regular size counterparts. During follow-up, none of the patients in the small group developed steal syndrome (0% vs. 9%, P = 0.015). At 1 year, patients in the regular size group achieved higher rates of primary patency (67.9% vs. 46.9%, P = 0.02); however, no difference was seen in 1-year primary-assisted patency (84.9% vs. 73.6%, P = 0.3), secondary patency (89.6% vs. 79.5%, P = 0.3), or functional patency (87.7% vs. 82.2%, P = 0.64) between the small and regular size groups, respectively. CONCLUSIONS: The use of a 5-6 mm anastomosis in the creation of new AVFs of the upper extremities appears to be a technically safe option for dialysis access. Our experience suggests that smaller anastomosis still creates enough flow to maintain a functional AV access while minimizing the incidence of steal syndrome. Additionally, even with smaller vein sizes preoperative, adequate dialysis access can be created via a small sized anastomosis, including distal arm access. Larger studies with longer follow-up are needed to evaluate long-term outcomes of small anastomosis fistulas.

A Single-Institution Case Series of Total Endovascular Relining for Type 3 Endoleaks in Traditional Endovascular Aneurysm Repair (EVAR) Grafts with Raised Bifurcations.

BACKGROUND: The endovascular repair of infrarenal abdominal aortic aneurysms can be performed with a wide variety of devices. Many of these grafts elevate the aortic bifurcation which can limit future repairs if the graft material fails thereby creating a type III endoleak to aorto-uniliac grafts. Many manufacturers have grafts susceptible to this, but we have seen this in the Medtronic AneuRx graft. Our goal is to provide technical details and outcomes regarding a novel technique to reline these grafts while maintaining inline flow to the iliac arteries. METHODS: This was a single-institution review of patients who had endoleaks requiring intervention after a previously placed graft with an elevated aortic bifurcation. Primary outcomes included technical success defined as placement of all planned devices, resolution of type III endoleak, aneurysm size at follow-up, and requirement of reintervention. Secondary outcomes included 30-day complications, aneurysm-related mortality, and all-cause mortality. Technical details of the operation include back-table deployment of an Ovation device, modification of the deployment system tether and pre-emptive placement of an up and over 0.014″ wire. The wire is placed up and over and hung outside the contralateral gate. Once the main body is introduced above the old graft, the 0.014" is snared from the contralateral side and externalized. The main body is then able to be seated at the bifurcation as the limb is not fully deployed and then device deployment is completed per instructions for use. RESULTS: Our study consists of 4 individuals, 3 of which had an abdominal aortic aneurysm initially managed with an AneuRx endovascular aneurysm repair and 1 with a combination of Gore and Cook grafts. All 4 patients were male with an average age of 84.5 years at time of reline. All patients had at least 10 years between initial surgery and reline at our institution. Primary outcomes revealed no type 1 or 3 endoleaks at follow-up, technical success was 100% and 1 patient required reintervention for aneurysm growth and type 2 endoleak. In terms of our secondary outcomes, there was 1 postoperative complication which was cardiac dysfunction secondary to demand ischemia, aneurysm-related mortality was 0% and all-cause mortality was 25% at average follow-up of 2.44 years. CONCLUSIONS: As individuals continue to age, there are more patients who would benefit from less invasive reinterventions following endovascular aneurysm repair. Whether this is due to aortic degeneration, stent migration, or stent material damage is not always known. In this study, we present an endovascular approach to treating type III endoleak patients with a previous graft and elevated aortic bifurcation using Ovation stent grafts and found no evidence of type 1 or 3 endoleaks on follow-up imaging. This approach may allow patients with type III endoleak the option of a minimally invasive, percutaneous approach where they previously would not have had one.

Upper Extremity Access Has Worse Outcomes in F/BEVAR Using the VQI Dataset.

BACKGROUND: Physician-modified endografts and custom-manufactured devices use branched and fenestrated techniques (F/BEVAR) to repair complex aneurysms. Traditionally, many of these are deployed through a combination of upper and lower extremity access. However, with newer steerable sheaths, you can now simulate upper extremity (UEM) access from a transfemoral approach. Single-institution studies have demonstrated increased risks of access site complications and stroke when UEM access is used. This study compares outcomes after F/BEVAR in a national database between total transfemoral (TTF) access and mixed UEM access. METHODS: This study is an analysis of the Vascular Quality Initiative for all patients who underwent F/BEVAR from 2014 to 2021. Patients were stratified based on a TTF delivery of all devices versus any UEM access for deployment of target vessel stents. Primary outcomes included stroke, myocardial infarction (MI), and perioperative death. Secondary outcomes included access site hematoma, occlusion or embolization, operative time, fluoroscopy time, and technical success. Multivariable linear and logistic regression analyses were performed. RESULTS: Three thousand one hundred forty six patients underwent an F/BEVAR: 2,309 (73.4%) TTF and 837 (26.6%) UEM. Logistic regression analysis indicated a two-fold increased risk of death and MI and a three-fold increased risk of stroke in the UEM group. Furthermore, there is decreased operative time (221 vs. 297 min, P < 0.001) and fluoroscopy time (62 vs. 80 min, P < 0.001) in the TTF group and no difference in technical success between groups (96% vs. 97%, P = 0.159). Finally, there was a decrease in access site hematoma 2.54% vs. 4.31% (P = 0.013), access site occlusion 0.61% vs. 1.91% (P = 0.001), and extremity embolization 2.17% vs. 3.58% (P = 0.026) in the TTF versus UEM group. CONCLUSIONS: This study using Vascular Quality Initiative data demonstrates that patients who undergo an F/BEVAR using UEM access have an increased risk of perioperative MI, death, and stroke compared to TTF access.

Vascular Surgery in Low-Income and Middle-Income Countries: A State-of-the-Art Review.

BACKGROUND: Cardiovascular disease (CVD) represents 32% of all global deaths. Studies have shown an increase in CVD prevalence and mortality with the most substantial increase in low-income and middle-income countries (LMICs). Within LMICs, we sought to 1) measure the burden of CVD with respect to aortic aneurysm (AA), ischemic stroke (IS), and peripheral arterial disease (PAD); 2) quantify surgical access to vascular surgery services; and 3) identify challenges and solutions to addressing disparities. METHODS: The Institute for Health Metrics and Evaluation Global Burden of Disease Results Tool was used to assess the global burden of CVD (AA, PAD, IS). Population data were extracted from the World Bank & Workforce data. A literature review was completed through PubMed. RESULTS: The number of deaths attributable to AA, PAD, and IS in LMICs increased by up to 102% between 1990 and 2019. Disability-adjusted life-years (DALYs) lost to AA, PAD, and IS in LMICs also increased by up to 67%. High-income countries (HIC) had a less considerable increase in deaths and DALYs during this time period. There are 101 and 72.7 vascular surgeons per 10 million people in the United States and United Kingdom, respectively. LMICs, such as Morocco, Iran, and South Africa have 10 times less this number. Ethiopia has 0.25 vascular surgeons per 10 million people, 400 times less than the United States. Interventions addressing these global disparities should address infrastructure and financing, data collection and sharing, patient knowledge and beliefs, and workforce development. CONCLUSIONS: Extreme regional discrepancies are evidence at a global scale. Identifying mechanisms to expand the vascular surgical workforce to meet the increasing need for vascular surgical access is imminent.

Two-Stage Offers No Advantages over Single-Stage Arteriovenous Creation: An Analysis of Multicenter National Data.

BACKGROUND: Traditionally, arteriovenous fistulas (AVF) involving the basilic vein (BV) have been created in 1 or 2 stages to allow time for the vein to enlarge before superficialization for potential better fistula maturation. Previous single institution studies and meta-analyses have found conflicting outcomes between single-stage and 2-stage procedures. Our study aims to use a large national database to assess the difference in outcomes between single-stage and 2-stage procedures for dialysis access. METHODS: We studied all patients undergoing BV AVF creation in the Vascular Quality Initiative (VQI) from 2011 to 2021. Patients were split into single-stage or a planned 2-stage procedure for dialysis access. Primary outcomes included dialysis use with index fistula, maturity rate, and number of days from surgery to fistula use. Secondary outcomes included patency (defined by physical exam or imaging on follow-up), 30-day mortality, and postoperative complications (bleeding, steal syndrome, thrombosis, or neuropathy). Logistic regression models were used to assess the association between staged dialysis access procedures and primary outcomes of interest. RESULTS: The cohort consisted of 22,910 individuals of which 7,077 (30.9%) had a 2-staged dialysis access procedure and 15,833 (69.1%) had a single-staged procedure. Average follow-up was 345 days in the single stage and 420 days for 2-stage. Baseline characteristics were significantly different between the 2 groups in terms of medical comorbidities. Primary outcomes were significant for more patients in the 2-stage group undergoing dialysis with the index fistula compared to single stage (31.5% vs. 22.2%, P < 0.0001), significant decrease in days to use in current dialysis patients (103.9 days single stage versus 141.0 days 2-stage, P < 0.0001), and no difference in maturity at follow-up (19.3% single-stage and 17.4% 2-stage, P = 0.354). Secondary outcomes revealed no difference in 30-day mortality or patency (89.8% single-stage and 89.1% 2-stage, P = 0.383), but a significant difference in postoperative complications with a 2-stage procedure compared to 1-stage (1.6% vs. 1.1%, P = 0.026). Finally, a spline model was used to determine that a preoperative vein of 3 mm or less could be a cutoff in which a 2-stage procedure might be beneficial. CONCLUSIONS: This study demonstrates that when dialysis access fistulas are created using the BV, there is no difference in maturity rate or 1-year patency when assessing single-stage versus 2-stage procedures. However, 2-stage procedures significantly delay the time of first use of the fistula and increase postoperative complications. Therefore, we suggest performing single stage procedures when the vein is of appropriate diameter to minimize multiple procedures, complications and expedite time to maturity.

Hemodynamic instability predicts in-hospital and 1-year mortality after transcarotid artery revascularization and transfemoral carotid stenting.

OBJECTIVE: Blood pressure fluctuations are a common hemodynamic alteration following carotid artery stenting either with transfemoral (TFCAS) or transcarotid (TCAR) approach and are thought to be related to alteration in baroreceptor function due to angioplasty and stent expansion. These fluctuations are particularly worrisome in the high-risk patient population referred for CAS. This study aims to evaluate the outcomes of patients who required the administration of intravenous blood pressure medication (IVBPmed) for hypotension or hypertension after CAS. METHODS: All patients undergoing carotid revascularization in the Vascular Quality Initiative (VQI) database between 2016 and 2021 were included. We compared outcomes of patients who required postoperative IVBPmed to treat hyper- or hypotension with normotensive patients. In-hospital outcomes were compared using multivariable logistic regression. One-year outcomes were assessed using Kaplan-Meier survival and multivariable Cox proportional hazard regression analyses. RESULTS: We identified 38,510 patients undergoing CAS (57.7% TCAR and 42.3% TFCAS), of which, 30% received IVBPmed for treatment of either postoperative hypertension (12.6%) or hypotension (16.4%). In multivariable analysis, postoperative hypotension was associated with a higher risk of stroke, death, or myocardial infarction (MI) (odds ratio [OR], 3.1; 95% confidence interval [CI], 2.6-3.6; P < .001), stroke or death (OR, 2.9; 95% CI, 2.4-3.5; P < .001), stroke (OR, 2.6; 95% CI, 2.1-3.2; P < .001), death (OR, 3.5; 95% CI, 2.6-4.8; P < .001), MI (OR, 4.7; 95% CI, 3.3-6.7; P < .001), and bleeding (OR, 1.96; 95% CI, 1.4-2.7; P < .001) compared with normotensive patients. Postoperative hypertension was associated with a higher risk of stroke, death, or MI (OR, 3.6; 95% CI, 3-4.4; P < .001), stroke or death (OR, 3.3; 95% CI, 2.7-4.1; P < .001), stroke (OR, 3.7; 95% CI, 3-4.7; P < .001), death (OR, 2.7; 95% CI, 1.9-3.9; P < .001), MI (OR, 5.7; 95% CI, 3.9-8.3; P < .001), and bleeding (OR, 1.9; 95% CI, 1.4-2.7; P < .001) compared with normotensive patients. CONCLUSIONS: Postoperative hypertension or hypotension requiring IVBPmed after CAS is associated with an increased risk of in-hospital stroke, death, MI, and bleeding. Postoperative hypertension is associated with worse survival at 1 year. This study indicates that the need for IVBPmed after CAS is not benign; therefore, these patients necessitate aggressive perioperative medical management and safe techniques to avoid hypo and hypertension. Close follow-up and continue medical management are needed to maximize these patients' survival.

Prophylactic Perigraft Arterial Sac Embolization During EVAR: Minimizing Type II Endoleaks and Improving Sac Regression.

BACKGROUND: Type II endoleaks (ELII) are the most common complication following endovascular aneurysm repair (EVAR). Persistent ELII require continual surveillance and have been shown to increase the risk of Type I and III endoleaks, sac growth, need for intervention, conversion to open or even rupture, directly or indirectly. These are often difficult to treat following EVAR, and there are limited data regarding the effectiveness of prophylactic treatment of ELII. The aim of this study is to report the midterm outcomes of prophylactic perigraft arterial sac embolization (pPASE) performed in patients undergoing EVAR. METHODS: This is a comparison of 2 elective cohorts of those undergoing EVAR using the Ovation stent graft with and without prophylactic branch vessel and sac embolization. Patients who underwent pPASE at our institution had their data collected in a prospective, institutional review board-approved database. These were compared against the core lab-adjudicated data from the Ovation Investigational Device Exemption trial. Prophylactic PASE was performed at the time of EVAR with thrombin, contrast, and Gelfoam if the lumbar or mesenteric arteries were patent. Endpoints included freedom from ELII, reintervention, sac growth, all-cause mortality, and aneurysm-related mortality. RESULTS: Thirty-six patients (13.1%) underwent pPASE, while 238 patients (86.9%) had standard EVAR. Median follow-up was 56 months (33-60 months). The 4-year freedom from ELII estimates were 84% for the pPASE versus 50.7% for the standard EVAR group (P = 0.0002). All aneurysms in the pPASE group remained stable in size or demonstrated regression, whereas aneurysm sac expansion was seen in 10.9% of the standard EVAR group, P = 0.03. At 4 years, mean AAA diameter decreased by 11 mm (95% CI 8-15) in the pPASE group versus 5 mm (95% CI 4-6) for the standard EVAR group, P = 0.0005. There were no differences in the 4-year freedom from all-cause mortality and aneurysm-related mortality. However, the difference in reintervention for ELII trended toward significance (0.0% vs. 10.7%, P = 0.1). On multivariable analysis, pPASE was associated with a 76% reduction in ELII [(95% CI): 0.24 (0.08-0.65), P = 0.005]. CONCLUSIONS: These results suggest that pPASE in those undergoing EVAR is safe and effective in the prevention of ELII and significantly improves sac regression over standard EVAR while minimizing the need for reintervention.

Effect of Postoperative Stroke Timing on Perioperative Mortality After Carotid Revascularization.

BACKGROUND: In-hospital stroke (IHS) has been associated with worse outcomes than out-of-hospital stroke (OHS) due to delays in diagnosis and treatment. A paucity of studies exists comparing the timing of postoperative stroke after carotid revascularization. We aimed to study the effect of IHS versus OHS on postoperative mortality in carotid revascularization patients in a large-scale national database. METHODS: This is a retrospective cohort study of patients who underwent carotid artery stenting (CAS) and carotid endarterectomy (CEA) between 2011 and 2018 in the American College of Surgeons (ACS) National Surgical Quality Improvement Program (NSQIP) database. Statistical analysis included chi-squared test and multivariable logistic regression. Patients were divided based on postoperative stroke timing (no stroke, IHS, or OHS) as well as procedure type (CEA or CAS). RESULTS: A total of 31,304 carotid revascularizations were performed with 420 (1.3%) IHSs and 207 (0.7%) OHSs. On adjusted analysis, there was significantly higher perioperative mortality with both IHS [odds ratio (OR): 19.75, 95% confidence interval (CI): 13.61-28.18, P < 0.001] and OHS [OR: 29.73, 95% CI: 18.76-45.82, P < 0.001]. There was no difference in mortality after OHS versus IHS [OR: 1.51, 95% CI: 0.89-2.55, P = 0.161]. CONCLUSIONS: Any postoperative stroke after carotid revascularization significantly increased the odds of 30-day mortality. In contrast to previous studies demonstrating worse outcomes after IHS than OHS, we observed similar 30-day mortality between the 2 stroke categories. Improved follow-up and early recognition with rescue within carotid revascularization patients compared to the general population could potentially contribute to these results. However, overall mortality remains high for any postoperative stroke following carotid revascularization, emphasizing the importance of vigilant in-hospital monitoring and follow-up even after discharging the patient.

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.

Revision of Aneurysmal Arteriovenous Access with Immediate Use Graft Is Safe and Avoids Prolonged Use of Tunneled Hemodialysis Catheters.

BACKGROUND: Aneurysmal arteriovenous fistulas (AVF) can pose a difficult treatment dilemma for the vascular surgeons. Prolonged tunneled dialysis catheters (TDCs) in patients requiring long-term dialysis are associated with significantly increased mortality compared to AVF. We aimed to elucidate the outcomes of aneurysmal arteriovenous (AV) access revision with aneurysm resection and Artegraft® (LeMaitre, New Brunswick, NJ) Collage Vascular Graft placement to avoid prolonged use of TDCs. METHODS: We reviewed all patients with aneurysmal AV access in whom the access was revised with aneurysm resection and jump graft placement at a single institution from 2018 to 2021. Outcomes were time to cannulation, reintervention rates, time to reintervention, and patency (primary, primary assisted, and secondary). Patency rates were estimated with Kaplan-Meier Survival analysis. RESULTS: A total of 51 revised aneurysmal AV accesses in 51 patients were studied, of which 23.5% (n = 12) had perioperative TDC placement. Three patients were done for emergent bleeding. The cohort was 62.8% male (n = 32) with a median age of 58 years (interquartile range: 49-67). Most patients had brachiocephalic AVF (n = 37 [72.6%]). The median follow-up time was 280 days. The median time to cannulation was 2 days. Time to cannulation was significantly longer in patients with perioperative TDC as compared with those without TDC (24 days vs. 2 days, P < 0.001). Reintervention was required in 41.2% of patients (n = 21), at median time of 47 days. At 30, 90, 180, and 365 days, primary patency rates were 84.3%, 78.3%, 66.6%, and 54.9%; primary assisted patency rates were 94.1%, 88.1%, 79.4%, and 79.4%; and secondary patency rates were 100%, 97.8%, 91.6%, and 91.6%, respectively. CONCLUSIONS: The revision of aneurysmal AV access (urgent or elective) with Artegraft as jump graft is safe, with acceptable short- and mid-term patency results. This allows dialysis patients to continue to have a functional access, decreasing the need for a tunneled catheter and reducing the associated risk of sepsis and increased mortality. This should be considered for all patients with aneurysmal, dysfunctional fistulas to maintain AV access and avoid TDC placement.

"Aortic Balloon Molding" during Ovation Endograft Implantation Expands Graft Use for Hostile Neck Anatomy.

BACKGROUND: Challenging aortoiliac anatomy such as short neck and narrow access vessels is responsible for endovascular repair of abdominal aortic aneurysm (EVAR) ineligibility in up to 50% of cases. The Ovation stent graft helped widen the range of abdominal aortic aneurysms (AAAs) suitable for EVAR thanks to its low-profile delivery system and polymer-filled sealing rings. However, its advantages are offset by a tight sizing chart that can lead to increased risk of type Ia endoleak or endograft infolding from under- or oversizing, respectively. We sought to assess the safety and efficacy of a novel endovascular technique developed to expand the use of the Ovation endograft while avoiding these issues. METHODS: We conducted a retrospective review of all patients who underwent EVAR with the Ovation endograft at our institution between March 2019 and December 2020. "Aortic Balloon Molding" or ABM is a novel endovascular technique in which the graft is pre-cannulated and a compliant aortic balloon is inflated at the site of the graft's sealing rings during polymer administration. The technique was preferentially performed in patients with hostile neck anatomy (HNA) defined as any or all of angulation >60°, reverse taper configuration, ≥50% circumferential thrombus, or calcification. Patients undergoing traditional deployment were compared to those in whom ABM was performed. End points included neck-related adjunctive procedures, technical success, type Ia endoleak at completion angiogram, and 1-year freedom from type Ia endoleak and migration. RESULTS: A total of 43 patients were included in the study, of which 26 (60.5%) were treated with the ABM technique. Mean follow-up was 7.9 ± 6 months. Patients in the ABM group were more likely to have a reverse taper neck (61.5% vs. 41.2%, P = 0.1), have significant circumferential thrombus or calcium (23.1% vs. 5.9%, P = 0.1), and be treated outside of the Ovation indications for use regarding anatomic characteristics (65.4% vs. 41.2%, P = 0.1). Technical success was achieved in 100% of cases. However, patients in the ABM group were less likely to require a neck-related adjunctive procedure (7.7% vs. 23.5%, P = 0.1). Only 1 type Ia endoleak was observed at completion angiogram in a patient treated without ABM. At 1 year, freedom from type Ia endoleak or migration was 100% for both groups. CONCLUSIONS: ABM proves to be a safe and effective adjunctive technique for the treatment of AAAs with HNA using the Ovation stent graft. This may allow optimal endograft sizing to achieve adequate seal in complex aortic anatomies. Further research is warranted to evaluate the long-term outcomes of this technique.

A Single Center Review of a Total Transfemoral Approach to Upper Extremity Access in Branched and Fenestrated Physician Modified Endografts.

BACKGROUND: Aortic aneurysms are normally treated by an endovascular approach. Due to the lack of devices and increasing experience, there is a growing number of complex aneurysms undergoing repair by physician modified endografts (PMEGs). Previously, our practice was to target visceral vessels exclusively through upper extremity access. We have since then shifted to an all transfemoral approach when possible. This study aims to show the operative benefits of transfemoral only approaches. METHODS: Patients who underwent a PMEG at a tertiary center between 2015 and 2020 were included. Patients were stratified into 2 groups based on branched vessel approach-transfemoral only versus axillary or composite (axillary and femoral). Forty-one patients had a pararenal or type IV thoracoabdominal aortic aneurysm (TAAA) and 15 patients had more complex TAAA. Primary outcomes were operative time, radiation exposure, fluoroscopy time, contrast, and blood loss. Secondary outcomes were 30-day mortality and major adverse events. Linear regression models were used to evaluate the association between approach type and the main outcomes. RESULTS: Fifty-six patients were included with 48% (n = 27) in the transfemoral group and 52% (n = 29) in the axillary/composite group. Baseline characteristics were similar between the groups. Intraoperative outcomes revealed significant increase in the average operative time (418 vs. 246 min, P < 0.001), in radiation exposure (2,755 vs. 1,740 mGy, P = 0.03), in fluoroscopy time (108 vs. 74 min, P = 0.01) and in blood loss (579 vs. 202 cc, P = 0.002) in the axillary/composite group compared to the transfemoral group. There was no significant difference in 30-day mortality or major adverse events including stroke. CONCLUSIONS: This study shows a transfemoral approach to complex endovascular aortic aneurysm repair as opposed to axillary/composite approach has decreased operative time, radiation exposure, and fluoroscopy time and no significant differences in 30-day mortality or major adverse events. When treating complex aneurysms, improving efficiency is important to minimize morbidity to patients and operators.

Outcomes of Endovascular-First Versus Bypass-First Approach for Patients With Chronic Limb-Threatening Ischemia Using a Medicare-Linked Database.

BACKGROUND: Chronic limb-threatening ischemia (CLTI) has been increasing in prevalence and remains a significant cause of limb loss and disability and a strong predictor of cardiovascular mortality. Previous studies have demonstrated that endovascular and open repair are similarly effective. These findings led to a significant increase in the adoption of the less-invasive endovascular-first (EVF) approach. However, it remains unknown whether the 2 treatment modalities have similar durability in today's real-world setting. The aim of the present study was to compare the midterm outcomes of the EVF and bypass-first (BF) strategies in patients with CLTI. METHODS: We identified all patients who had undergone limb revascularization from January 2010 to December 2016 in the Vascular Quality Initiative Medicare-linked database. Patients with a history of previous revascularization and those who had undergone hybrid or suprainguinal procedures were excluded from the present study. The remaining patients were divided into 2 groups: EVF and BF. The main end points were 2-year limb salvage, freedom from reintervention, amputation-free survival (AFS), and freedom from all-cause mortality (ACM). RESULTS: The EVF approach was applied to 12,062 patients (70%) and the BF approach to 5,166 patients (30%). The median follow-up was 33 months (interquartile range [IQR]: 14-49). Patients in the EVF group were older and had more comorbidities and tissue loss. At 2 years, the BF group had achieved greater rates of limb salvage (86.4% vs. 82.1%; P < 0.001), freedom from reintervention (72% vs. 68%; P < 0.001), AFS (66.9% vs. 56.3%; P < 0.001), and freedom from ACM (75.7% vs. 66.1%; P < 0.001). After adjusting for potential confounders, an effect of the treatment strategy on limb salvage (adjusted hazard ratio [aHR], 1.03; 95% confidence interval [CI], 0.93-1.16; P = 0.55), reintervention (aHR, 0.95; 95% CI, 0.89-1.019; P = 0.06), AFS (aHR, 0.94; 95% CI, 0.89-1.007; P = 0.08), and ACM (aHR, 0.93; 95% CI, 0.87-1.001; P = 0.055) was not observed. CONCLUSIONS: The present study is the largest real-word analysis showing the noninferiority of the EVF approach in patients with CLTI, with similar limb salvage, durability, AFS, and ACM compared with the BF approach. However, level 1 evidence on the role of the revascularization strategy in these challenging patients is needed.

The correlation of aortic neck length to late outcomes following EVAR with the Ovation stent graft.

OBJECTIVE: Endovascular aneurysm repair (EVAR) performed outside manufacturers' instructions for use due to short aortic neck for the treatment of abdominal aortic aneurysm (AAA) is associated with unfavorable outcomes. Newer endografts now have an indication for shorter neck aneurysms that previous endografts do not, but this cohort has yet to be evaluated individually. The aim of this study is to evaluate 5-year outcomes after EVAR in patients with short aortic necks (<10 mm) using the Ovation stent graft. METHODS: The study comprised 238 patients who underwent EVAR as part of the prospective international multicenter Ovation stent graft trials. The main inclusion criteria were AAA diameter ≥ 5 cm, proximal parallel neck length ≥7 mm, neck angulation ≤60°, and bilateral iliac fixation length ≥10 mm. A clinical events committee adjudicated adverse events through 1 year, an independent imaging core laboratory analyzed imaging through 5 years, and a data safety and monitoring board provided study oversight. Patients were divided into short neck (<10 mm) and standard neck (≥10 mm) groups. End points included long-term survival, freedom from aneurysm-related mortality (ARM), freedom from type Ia endoleak, and freedom from reintervention. RESULTS: Patients were predominantly male (81%) with a mean age of 73 ± 8 years. Median follow-up time was 58 months (interquartile range, 36-60 months). Of 238 patients, 41 (17.2%) had a proximal neck length <10 mm and would be considered outside the instructions for use with other stent grafts. Baseline characteristics were relatively similar between the two groups. The 5-year overall survival estimates were 77.8% for the standard neck group compared with 59.5% for the short neck group (P = .03). There were no differences in the 5-year freedom from ARM (99.2% vs 100%; P = .7), freedom from type Ia endoleak (96.3% vs 96.3%; P = .8), and freedom from reintervention (77.9% vs 79.7%; P = .7) between the standard and short neck groups, respectively. After adjusting for age and other potential confounders, short proximal neck was associated with a two-fold increase in 5-year all-cause mortality (adjusted hazard ratio, 2; 95% confidence interval, 1.02-3.8; P = .04]. CONCLUSIONS: The Ovation endograft performed well in short AAA neck with no difference in 5-year type Ia endoleak, reintervention, and ARM rates. However, short proximal neck was independently associated with a two-fold increase in the risk of all-cause mortality at 5 years. These findings confirm the prior literature on the association of hostile neck anatomy with late mortality following EVAR.

Contemporary outcomes of concomitant suprainguinal bypass with infrainguinal revascularization procedures in patients with chronic limb-threatening ischemia.

OBJECTIVE: Combined suprainguinal and infrainguinal revascularization is sometimes necessary in the treatment of patients with chronic limb-threatening ischemia (CLTI). However, data on outcomes of concomitant revascularization procedures are lacking. We studied the outcomes of patients with CLTI who underwent suprainguinal bypass (SIB) alone, SIB with concomitant infrainguinal bypass (IIB), and SIB with concomitant infrainguinal peripheral endovascular intervention (IIPVI). METHODS: We reviewed all patients in the Vascular Quality Initiative with CLTI who underwent SIB from January 2010 to June 2020. Logistic regression, Kaplan-Meier survival estimates, log-rank tests, and Cox regression were used to analyze outcomes. Outcomes were 30-day mortality, perioperative myocardial infarction, perioperative major amputation, 1-year amputation-free survival, and 5-year survival. RESULTS: Of 8037 patients included, 81.3% (n = 6537) underwent SIB alone, 9.7% (n = 783) underwent SIB+IIB, and 8.9% (n = 717) underwent SIB+IIPVI. The indication for surgery was rest pain in 5040 (62.5%) and tissue loss in 3031 (37.6%). There were no significant differences in 30-day mortality and perioperative myocardial infarction rates. However, there was 2.8-fold increased odds of perioperative major amputation in both SIB+IIPVI (odds ratio [OR], 2.76; 95% confidence interval [CI], 1.30-5.88; P = .008) and SIB+IIB (OR, 2.79; 95% CI, 1.38-5.54; P = .004) among patients with rest pain as compared with SIB alone. Comparing SIB+IIPVI with SIB alone, there were no significant differences in 1-year freedom from amputation and amputation-free survival. SIB+IIPVI was associated with a 27% increased risk of 5-year mortality (hazard ratio [HR], 1.27; 95% CI, 1.03-1.55; P = .035). Compared with SIB alone, SIB+IIB was associated with 97% increased risk of 1-year major amputation among patients with rest pain (HR, 1.97; 95% CI, 1.06-3.69; P = .033), but a 47% decreased risk of 1-year major amputation or death for patients with tissue loss (HR, 0.53; 95% CI, 0.37-0.78; P = .001). SIB+IIPVI, compared with SIB+IIB, was associated with a two-fold increased risk of 1-year major amputation or death (HR, 2.04; 95% CI, 1.04-2.23), P = .003) and a 52% increased risk of 5-year mortality (HR,1.52; 95% CI, 1.04-2.24; P = .032) among patients with tissue loss. CONCLUSIONS: This study shows that SIB with concomitant infrainguinal revascularization in patients with rest pain is associated with an increased risk of amputation, whereas SIB+IIB in patients with tissue loss is associated with decreased risk of amputation or death. SIB+IIB outperformed SIB+IIPVI in patients with tissue loss. SIB with infrainguinal revascularization should be limited in patients with rest pain in line with current guidelines, but SIB+IIB may be preferred in patients with tissue loss.

Polymer based endografts have improved rates of proximal aortic neck dilatation and migration.

BACKGROUND: Proximal aortic neck dilatation (PND) affects a considerable proportion of patients undergoing endovascular aneurysm repair (EVAR) and is associated with increased rates of type I endoleak (EL1), migration, and reinterventions. Although there are numerous studies investigating PND following the placement of endografts that utilize self-expanding stent (SES) technology, there are few reports for patients treated with endografts that utilize polymer-filled rings. The purpose of this study is to examine PND and graft migration after EVAR with the Ovation stent graft. METHODS: The study comprised patients who underwent EVAR as part of the prospective, international, multicenter Ovation stent graft trial. A clinical events committee adjudicated adverse events through 1 year, an independent imaging core laboratory analyzed imaging through 5 years, and a data safety and monitoring board provided study oversight. Neck diameter was measured at the level of the lowest renal artery. PND was defined as neck enlargement of 3 mm or more. Graft migration was defined as distal movement >10 mm or movement ≤10 mm when resulting in secondary intervention. RESULTS: A total of 238 patients received this device during the study period. Patients were predominantly male (81%), with a mean age of 73 ± 8 years. Median follow-up was 58 months (IQR 36-60). Almost half the patients (110 patients, 46%) had challenging anatomy; defined as outside the instructions for use (IFU) with other commercially available stent grafts. 41 patients (17.2%) had a proximal neck length <10 mm and 93 (39%) had a minimum access vessel diameter <6 mm. The technical success rate was 100%. The 1-, 3- and 5-year overall survival rates were 96.6%, 86.2% and 74.9%, respectively. The immediate postoperative proximal neck diameter ranged from 16 mm to 31 mm with a mean of 22.4 ± 3 mm. During follow-up, ten patients (4.2%) developed PND. Freedom from PND estimates at 1, 3 and 5 years were 97.7%, 96%, and 93.6%, respectively. None of the patients developed endograft migration. CONCLUSIONS: The use of the Ovation stent graft was associated with low rates of PND despite challenging neck anatomy in 17% of patients. No graft migration was observed. The design of this endograft may explain its superiority to SES in preventing neck dilatation and migration even in patients with challenging neck anatomy. This is important, as we continue to see significant late failures of EVAR due to proximal neck degeneration.

The association of estimated glomerular filtration rate with outcomes following infrainguinal bypass for peripheral arterial disease.

OBJECTIVE: Chronic kidney disease (CKD) is a recognized predictor of long-term survival, frequently coexisting with peripheral arterial disease (PAD). Estimated glomerular filtration rate (eGFR) is a more accurate marker of renal function than creatinine. This study sought to determine the graded impact of CKD, defined by eGFR, on infrainguinal lower extremity bypass (LEB) outcomes. METHODS: This retrospective study examined 44,332 patients from the Vascular Quality Initiative database who underwent LEB between January 2003 and November 2019. The GFR was estimated using the Modification of Diet in Renal Disease equation. Multivariable logistic regression was used to study perioperative mortality and Kaplan-Meier survival estimation and multivariable Cox regression were used to evaluate 5-year mortality, 1-year major amputation, and major amputation/death. RESULTS: The 30-day mortality odds was increased for CKD 3 (odds ratio [OR], 1.58; 95% confidence interval [CI], 1.32-1.91; P < .001) and CKD 5 (OR, 3.08; 95% CI, 2.45-3.87; P < .001) relative to CKD 1 to 2. Comparing CKD stages 3, 4, and 5 with CKD 1 and 2, there was a stepwise increase in the adjusted hazard of 5-year mortality (hazard ratio [HR], 1.18; 95% CI, 1.09-1.27; P < .001), (HR, 1.73; 95% CI; 1.47-2.03; P < .001) and (HR, 2.58; 95% CI, 2.33-3.84; P < .001), respectively. Although the risk of 1-year death or major amputation did not differ for CKD 3 compared with CKD 1, this was 50% higher for CKD 4 (HR, 1.50; 95% CI, 1.26-1.78; P < .001) and doubled for CKD 5 (HR, 2.07; 95% CI, 1.87-2.29; P < .001) compared with CKD 1 and 2. The adjusted HR for major amputation in 1 year was 0.81 (95% CI, 0.71-0.92; P = .002), 1.14 (95% CI, 0.84-1.54; P = .396) and 1.56 (95% CI,1.31-1.84; P < .001) for CKD 3, 4, and 5, respectively, compared with CKD 1 and 2. CONCLUSIONS: The estimated GFR is a useful predictor of postoperative mortality, overall survival, and/or amputation after LEB in patients with PAD. It should be considered in the preoperative risk-benefit analysis process to guide patient selection in the population with concomitant PAD and CKD being considered for LEB.

Prophylactic Aneurysm Embolization during EVAR Is Safe, Improves Sac Regression and Decreases the Incidence of Type II Endoleak.

BACKGROUND: Clinically significant endoleaks remain costly, time-consuming, morbid and even mortal following endovascular aneurysm repair (EVAR). Perigraft arterial sac embolization (PASE) has been utilized to treat type II endoleaks (T2EL) diagnosed at the time of EVAR or after repair. Our objective was to analyze the safety and efficacy of prophylactic PASE on the incidence of T2EL and aneurysm sac regression in patients undergoing EVAR. METHODS: We performed a retrospective review of prospectively maintained databases from the University of California San Diego and the San Diego Veterans Affairs hospitals between 2015 and 2019. Prophylactic PASE (pPASE) was performed at the time of EVAR with thrombin, contrast and gelfoam liquid embolic aneurysm treatment as previously described. We evaluated technical success, freedom from T2EL, freedom from reintervention, from sac expansion, from type I/III EL, from all-cause mortality (ACM), from aneurysm-related mortality and from non-target embolization (NTE). RESULTS: A total of 44 patients were included in the study. Technical success was 100% and no NTE was observed. The average duration of follow-up was 14 ± 11months. In those treated and followed by CT scan, 100% of patients' aneurysms halted their growth following PASE, while 65.9% demonstrated sac regression. Mean aneurysm sac diameter decreased by 9 mm (95% CI 7-12). At 3 years, freedom from T2EL was 87.1%. Presence of T2EL did not result in aneurysm expansion during the follow-up period and thus did not require reintervention in any of these patients. Freedom from re-intervention was 83.2% for Type Ib EL and limb occlusion and all procedures were determined to be successful at the time of completion. No aneurysm-related deaths occurred during the follow-up. CONCLUSIONS: PASE proves to be an effective tool in sac management for prophylaxis of endoleak and maximizing sac regression in EVAR. It is safe, effective and durable when employed in this manner in the short and medium-term and was associated with low rates of T2ELs and reinterventions and a 100% freedom from sac expansion. Further analysis is required to evaluate the long-term outcomes of this adjunctive procedure in EVAR.

Short Duration Catheter-directed Thrombolysis for Acute Pulmonary Embolism Rapidly Improves Acute Cardiac Function.

BACKGROUND: Treatment of massive and submassive pulmonary embolism (PE) has been shown to be a valuable therapeutic modality. However, a paucity of data exists, regarding length and guidelines for treatment and typically these patients are treated by other than vascular surgery specialists. The aim of this study is to evaluate the effectiveness and safety of short duration treatment of massive and submassive PE, exclusively by vascular surgeons, without routine follow-up pulmonary angiography. METHODS: Retrospective analysis of prospectively collected data at a single-institution treating massive and submassive PE with catheter-directed thrombolysis (CDT). Internal review board approval was obtained. Descriptive statistical analysis was performed from the data set. Continuous covariates were presented in mean (SD) or median (IQR) and categorical covariates as number (percentage). For continuous variables, a paired t test was used to measure results against the baseline. P value less than 0.05 was defined as statistically significant. STATA® statistical software was used for analysis. RESULTS: From January of 2013 to December of 2016, 28 consecutive patients were treated for massive and submassive PE with CDT. All patients had evidence of right heart strain on echocardiogram, as evidence by a right ventricular to left ventricular (RV/LV) diameter ratio of >0.9. Of the 28 patients, 19 (68%) had hemodynamic derangement with either systolic blood pressure (SBP) less then 90 or tachycardia (HR > 100). The mean RV/LV ratio before CDT was 1.18. After therapy, RV/LV ratio was reduced to 0.86 at 48 hr (P < 0.0001). In addition, mean right ventricular systolic pressure (RVSP) before CDT treatment was 53 mm Hg, and after treatment, RVSP was reduced to 40 mm Hg at 48-hr (P value = 0.0001). There was complete resolution of hypotension in hemodynamically unstable patients (i.e., SBP <90) after CDT. Mean HR before therapy was 102. After 24 hr of CDT, mean HR reduced to 84 (P < 0.0001). From 2013 to 2016, there was a significant decrease in mean hospital length of stay from 8 days to 4 days (P = 0.05). Mean t-PA dose used decreased, as well, from 2014 (21.7 mg) to 2016 (14.9 mg), but this was not statistically significant (P = 0.13). There was no major bleeding complications or CDT-related death in any of the patients treated during the study period. CONCLUSIONS: CDT treatment of massive and submassive PE is safe and highly efficacious at reducing right heart strain acutely. Significant hemodynamic improvement was shown in our cohort throughout the study period. Improvement in tachycardia and resolution of hypotension were seen within 24 hr of CDT. Tissue plasminogen activator dosage decreased throughout the study period as a more restrictive approach to follow-up angiography was used without adverse safety or patient outcomes.