Variability in short-term mortality following repair of ruptured abdominal aortic aneurysms across centers and physicians.

BACKGROUND: Variation in the care management of repairs for ruptured infrarenal abdominal aortic aneurysms between centers and physicians, such as procedural volumes, may explain differences in mortality outcomes. First, we quantified the center and physician variability associated with 30- and 90-day mortality risk after ruptured open surgical repair (rOSR) and ruptured endovascular aneurysm repair (rEVAR). Second, we explored wheter part of this variability was attributable to procedural volume at the center and physician levels. METHODS: Two cohorts including rOSR and rEVAR procedures between 2013 and 2019 were analyzed from the Vascular Quality Initiative database. Thirty- and 90-day all-cause mortality rates were derived from linked Medicare claims data. The median odds ratio (MOR) (median mortality risk from low- to high-risk cluster) and intraclass correlation coefficient (ICC) (variability attributable to each cluster) for 30- and 90-day mortality risks associated with center and physician variability were derived using patient-level adjusted multilevel logistic regression models. Procedural volume was calculated at the center and physician levels and stratified by quartiles. The models were sequentially adjusted for volumes, and the difference in ICCs (without vs with accounting for volume) was calculated to describe the center and physician variability in mortality risk attributable to volumes. RESULTS: We included 450 rOSRs (mean age, 74.5 ± 7.6 years; 23.5% female) and 752 rEVARs (76.4 ± 8.4 years; 26.1% female). After rOSRs, the 30- and 90-day mortality rates were 32.9% and 38.7%, respectively. No variability across centers and physicians was noted (30- and 90-day MORs ≈1 and ICCs ≈0%). Neither center nor physician volume was associated with 30-day (P = .477 and P = .796) or 90-day mortality (P = .098 and P = .559). After rEVAR, the 30- and 90-day mortality rates were 21.3% and 25.5%, respectively. Significant center variability (30-day MOR, 1.82 [95% confidence interval (CI), 1.33-2.22]; ICC, 11% [95% CI, 2%-36%]; and 90-day MOR, 1.76 [95% CI, 1.37-2.09]; ICC, 10% [95% CI, 3%-30%]), but negligeable variability across physicians (30- and 90-day MORs ≈1 and ICCs ≈0%) were noted. Neither center nor physician volume were associated with 30-day (P = .076 and P = .336) or 90-day mortality risk (P = .066 and P = .584). The center variability attributable to procedural volumes was negligeable (difference in ICCs, 1% for 30-day mortality; 0% for 90-day mortality). CONCLUSIONS: Variability in practice from center to center was associated with short-term mortality outcomes in rEVAR, but not for rOSR. Physician variability was not associated with short-term mortality for rOSR or rEVAR. Annualized center and physician volumes did not significantly explain these associations. Further work is needed to identify center-level factors affecting the quality of care and outcomes for ruptured abdominal aortic aneurysms.

Intravascular Ultrasound Use is Associated with Improved Patency in Lower Extremity Peripheral Arterial Interventions.

BACKGROUND: Intravascular ultrasound (IVUS) facilitates detailed visualization of endoluminal anatomy not adequately appreciated on conventional angiography. However, it is unclear if IVUS use improves clinical outcomes of peripheral vascular interventions (PVIs) for peripheral arterial disease. This study aimed to evaluate the impact of IVUS on 1-year outcomes of PVI in the vascular quality initiative (VQI). METHODS: The VQI-PVI modules were reviewed (2016-2020). All patients with available 1-year follow-up after lower extremity PVI were included and grouped as IVUS-PVI or non-IVUS PVI based on use of IVUS. Propensity matching (1:1) was performed using demographics and comorbidities. One-year major amputation and patency rates were compared. A generalized estimating equation model was used to identify predictors of 1-year outcomes. Subgroup analysis based on Trans-Atlantic Intersociety Consensus (TASC) classification, treatment length and treatment modalities were performed using same modeling approaches. RESULTS: There were 56,633 procedures (non-IVUS PVI = 55,302 vs. IVUS-PVI = 1,331) in 44,042 patients. Propensity matching yielded a total cohort of 1,854 patients matched (1:1), with no baseline differences. Lower extremity revascularization for claudication was performed in 60.4%, while one-third (33.9%) had chronic limb threatening ischemia (CLTI). IVUS was more commonly used for lesions >15 cm in length (46.6% vs. 43.3%) and for aortoiliac disease (31.8% vs. 27.2%). Rates of atherectomy and stenting were significantly higher with IVUS-PVI (21.1% vs. 16.8%), while balloon angioplasty was less common (13.5% vs. 24.4%). One-year patency was better with IVUS-PVI (97.7% vs. 95.2%, P = 0.004). On subgroup analysis, IVUS (odds ratio [OR] 2.20, 95% confidence interval [CI] 1.29-3.75) was associated with improved patency in CLTI patients, TASC C or D lesions, and treatment length >15 cm. Adjunctive IVUS use during PVI did not significantly impact 1-year amputation (OR 1.7, 95% CI 0.78-3.91). On multivariable regression, adjunctive use of IVUS (OR 2.46 95% CI 1.43-4.25) and aortoiliac interventions (OR 2.91, 95% CI 1.09-7.75) were independent predictors of patency. Treatment modalities such as atherectomy, stenting or balloon angioplasty did not significantly impact patency at 1-year. CONCLUSIONS: IVUS during lower extremity PVI is associated with improved 1-year patency, when compared to angiography alone. Certain subgroups, such as CLTI patients, lesions>15 cm, and TASC C or D lesions might benefit from adjunctive use of IVUS.

The Utilization of Protamine during Peripheral Vascular Interventions in the VQI.

BACKGROUND: Protamine administration was shown to reduce bleeding after carotid surgery but the role of protamine during peripheral vascular interventions (PVIs) remains unknown. This study evaluates the trend and outcomes of protamine use in the Vascular Quality Initiative (VQI). Our hypothesis is that the use of protamine is associated with decreased bleeding after PVI. METHODS: Patients undergoing elective PVI in the VQI (2016-2020) for peripheral arterial disease were reviewed and the utilization trend for protamine was described. The characteristics of patients undergoing PVI with and without protamine use were compared. After propensity score matching based on the patient's comorbidities, access site, and procedural characteristics, the perioperative outcomes of both groups were compared using multivariable Poisson regression to estimate adjusted rate ratios (aRRs) and 95% confidence intervals (95% CIs). RESULTS: The total number of patients was 131,618 and patients who received protamine constituted 29.8% of the sample (N = 38,191). After propensity matching, the total number of patients was 94,582, and patients who received protamine constituted 28.8% of the sample (N = 27,275). Protamine use significantly increased during the study period from 5.2 to 22.9%. Before propensity score matching, patients who received protamine were more likely to be white (79% vs. 76.8, P ≤ 0.001), smokers (80.5% vs. 78.5%, P ≤ 0.001), with medical comorbidities including hypertension (88.9% vs. 88.5%, P = 0.074), congestive heart failure (20.5% vs. 19.8%, P = 0.006), and chronic obstructive pulmonary disease (28.2% vs. 26.5%). They were also more likely to be on perioperative medications such as P2Y12 inhibitors (44.3% vs. 45, P = 0.013%) and statin (77.4% vs. 76.5%, P = 0.001) compared to patients who did not receive protamine. After propensity matching, there were no significant differences between the 2 groups. There was a significant decrease in bleeding during procedures where protamine was administered compared to no protamine (2.0% vs. 2.2%) (aRR, 0.89 [95% CI 0.80, 0.98]). Protamine was more likely to be given in procedures complicated by perforation (0.8% vs. 0.5%) (aRR, 1.48 [95% CI 1.24, 1.76]) and less likely to be given during procedures with distal embolization (0.4% vs. 0.7%) (aRR, 0.59 [95% CI 0.49, 0.73]). However, patients receiving protamine had significantly higher cardiac complications (1.4% vs. 1.1%) (aRR, 1.27 [95% CI 1.12, 1.43]). There was no significant difference in mortality between the 2 groups. CONCLUSIONS: Protamine use is associated with decreased perioperative bleeding but increased cardiac complications. Protamine should be selectively administered to patients at high risk of bleeding during PVI.

The Use and Impact of Cilostazol on Patients Undergoing Endovascular Peripheral Interventions.

BACKGROUND: Cilostazol is used for the treatment of intermittent claudication. The impact of cilostazol on the outcomes of peripheral vascular interventions (PVIs) remains controversial. This study assesses the use and impact of cilostazol on patients undergoing PVI for peripheral arterial disease (PAD). METHODS: The Vascular Quality Initiative (VQI) database files for PVI were reviewed. Patients with PAD who underwent PVI for chronic limb threatening-ischemia or claudication were included and divided based on the use of cilostazol preoperatively. After propensity matching for patient demographics and comorbidities, the short-term and long-term outcomes of the 2 groups (preoperative cilostazol use versus no preoperative cilostazol use) were compared. The Kaplan-Meier method was used to determine outcomes. RESULTS: A total of 245,309 patients underwent PVI procedures and 6.6% (N = 16,366) were on cilostazol prior to intervention. Patients that received cilostazol were more likely to be male (62% vs 60%; P < 0.001), White (77% vs. 75%; P < 0.001), and smokers (83% vs. 77%; P < 0.001). They were less likely to have diabetes mellitus (50% vs. 56%; P < 0.001) and congestive heart failure (14% vs. 23%; P < 0.001). Patient on cilostazol were more likely to be treated for claudication (63% vs. 40%, P < 0.001), undergo prior lower extremity revascularization (55% vs. 51%, P < 0.001) and less likely to have undergone prior minor and major amputation (10% vs. 19%; P < 0.001) compared with patients who did not receive cilostazol. After 3:1 propensity matching, there were 50,265 patients included in the analysis with no differences in baseline characteristics. Patients on cilostazol were less likely to develop renal complications and more likely to be discharged home. Patients on cilostazol had significantly lower rates of long-term mortality (11.5% vs. 13.4%, P < 0.001 and major amputation (4.0% vs. 4.7%, P = 0.022). However, there were no significant differences in rates of reintervention, major adverse limb events, or patency after PVI. Amputation-free survival rates were significantly higher for patients on cilostazol, after 4 years of follow up (89% vs. 87%, P = 0.03). CONCLUSIONS: Cilostazol is underutilized in the VQI database and seems to be associated with improved amputation-free survival. Cilostazol therapy should be considered in all patients with PAD who can tolerate it prior to PVI.

Perioperative complications of minor and major reinterventions for peripheral arterial disease.

INTRODUCTION: Patients with peripheral arterial disease (PAD) frequently require reinterventions after lower-extremity revascularization (LER) to maintain perfusion. Current Society for Vascular Surgery guidelines define reinterventions as major or minor based on the magnitude of the procedure. While prior studies have compared primary LER procedures of different magnitudes, similar studies for reinterventions have not been performed. The objective of this study is to compare perioperative outcomes associated with major and minor reinterventions. METHODS: Patients undergoing LER for PAD at a tertiary care center from 2013 to 2017 were included. A retrospective review of electronic medical records was performed, and reinterventions were categorized as major or minor based on the procedure magnitude. Minor reinterventions included endovascular procedures and open revision with patch angioplasty, while major reinterventions were characterized by open surgical or endovascular LER with catheter-directed thrombolysis (CDT). Perioperative outcomes following LER were captured and compared for major and minor reinterventions. An additional subgroup analysis was performed comparing outcomes associated with major reinterventions stratified into open major surgical reinterventions and CDT. RESULTS: This study included 713 patients over a mean follow-up of 2.5 years. A total of 291 patients underwent 696 ipsilateral reinterventions (range = 1-12 reinterventions). Most reinterventions were minor (72.1%, N = 502) and 27.9% (N = 194) were major. Patients receiving reinterventions had an average age of 67.2 ± 11.5 and most were white (73.5%) males (60.1%) initially treated for claudication (58.2%) and CLTI (41.8%). There was significantly higher post-operative bleeding (9.8% vs 3.4%, p = .001), arterial thrombosis (3.1% vs 1.0%, p = .047), and acute renal failure (6.2% vs 2.4%, p = .014) after major reinterventions than minor. Additionally, major reinterventions had significantly higher return to the OR (17.0% vs 11.3%, p = .046) and longer hospital stays (7.5 vs 4.3 days, p = <.0001). Overall, major reinterventions were associated with significantly increased perioperative morbidity (37.6% vs 19.7%, p ≤ .001) with no difference in perioperative mortality. In the subgroup analysis, open reinterventions resulted in significantly longer hospital stays (8.6 days vs 5.5 days, p ≤ .001) and more wound infections than CDT (11.0% vs 0%, p = .017). However, there was no other significant difference in morbidity or mortality following treatment with open surgical reinterventions or CDT. CONCLUSIONS: In this study, major reinterventions after LER were associated with greater perioperative morbidity than minor reinterventions, with no difference in mortality. Major reinterventions performed via open surgery and CDT had similar morbidity and mortality.

Clinician perspectives regarding CYP2C19 genotype testing in patients with critical limb ischemia: A Delphi approach.

OBJECTIVES: Antiplatelet therapy is an essential element in the management of patients with arterial vascular disease. In peripheral arterial disease (PAD), dual antiplatelet therapy (DAPT), primarily clopidogrel and aspirin, is routinely prescribed following intervention. There is sparse data regarding the need for DAPT, the appropriate duration, or the heterogeneity of treatment effects for antiplatelet regimens across patients, leading to potential uncertainty and heterogeneity around treatment practices. An example of heterogeneity of treatment effects is a patients' metabolizer status for the use of clopidogrel. The aim of the study was to (1) assess clinicians' knowledge of and attitudes toward managing patients with CYP2C19 mutations, (2) identify barriers to implementation of CYP2C19 testing and management policies, and (3) reach consensus for CYP2C19 testing and management strategies for patients with PAD who undergo peripheral vascular interventions (PVI). METHODS: A modified Delphi method was used to establish consensus amongst PAD interventionalists around CYP2C19 testing. All practicing Yale New Haven Hospital PAD interventionalists with backgrounds in interventional cardiology, vascular surgery, or interventional radiology were approached by email for participation. Round 1 included the collection of baseline demographic questions, knowledge questions, and three statements for consensus. Knowledge questions were rated on a 0-10 Likert scale with the following anchors: 0 ("Not at all"), 5 ("Neutral), and 10 ("Very Much"). Participants were asked to rate the importance of the three consensus statements on a 9-point Likert scale from 1 ("Strongly Disagree") to 10 ("Strongly Agree"). In Round 2, participants were shown the same consensus statements, the median response of the group from the previous round, and their previous answers. Participants were instructed to revise their rating using the results from the previous round. This process was repeated for Round 3. RESULTS: Of the 28 experts invited to participate, 13 agreed (46%). Participants were predominantly male (92.3%) and white (61.5%) with representation from interventional cardiology (46.2%) and vascular surgery (53.8%). Most participants reported more than 10+ years in practice (61.5%). PAD interventionalists felt they would benefit from more education regarding CYP2C19 mutations (median score 8.0, interquartile range 5.0-8.5). They indicated some familiarity with CYP2C19 mutations (7.0, 6.0-9.5) but did not feel strongly that CYP2C19 was important to their practice (6.0, 5.5-7.5). In each round, the median responses for the three consensus statements were 5, 6, and 9, respectively. With each successive round the interquartile range narrowed indicative of evolving consensus but did not reach the prespecified interquartile range for consensus of 1 for any of the statements. CONCLUSIONS: PAD interventionalists practicing at an academic health system recognize the heterogenous response of their patients to clopidogrel therapy but are unsure when to leverage genetic testing to improve outcomes for their patients. Our study identified gaps regarding PAD interventionalists' knowledge, perceived barriers, and attitudes toward CYP2C19 testing in PAD. This information highlights the need for randomized data on genetic testing for clopidogrel responsiveness in peripheral vascular disease following intervention to help guide antiplatelet management.

Virtual vascular surgery interest group during the coronavirus disease 2019 pandemic.

OBJECTIVES: Early exposure to vascular surgery at the medical student level positively influences one's decision to apply into an integrated vascular surgery residency program. Vascular surgery interest groups (VSIGs) are student-run and aim to facilitate such exposure, traditionally via in-person events. Social distancing during the coronavirus disease 2019 pandemic disrupted these interactions. This is a description of the virtual activities of a VSIG group during the 2020-2021 academic year and highlights their impact among medical students. METHODS: The virtual activities of the VSIG at the Yale School of Medicine were reviewed. Students received surveys prior and after activities to assess their impact. Preactivity and postactivity surveys using Likert scale (1 = completely disagree; 5 = completely agree) were administered and compared. Statistical significance was achieved with a P value of less than .05. RESULTS: A total of five virtual events were held: an Introductory Session (October 2020), a Simulation Session (November 2020), a Research Night (January 2021), a Journal Club (February 2021), and a National Match Panel (April 2021). The surveys of three events (Introductory Session, Simulation Session, and National Match Panel) were analyzed. Attendance at these events were 18, 55, and 103 respectively. The average presurvey response rate was 51.2% and the average postsurvey response rate was 27.46%. Students agreed that the Introductory Session increased their knowledge about vascular surgery as a subspecialty (4.22 ± 0.67) and that the session was valuable to their time (4.33 ± 1.00). The Simulation Session increased student's comfort with knot tying from 1.73 ± 0.89 to 3.21 ± 1.25 (P < .001). Students reported an increased understanding of residency program selection (2.39 ± 1.10 vs 3.21 ± 1.12; P = .018), the Electronic Residency Application Service application (2.16 ± 1.01 vs 3.00 ± 0.88; P = .007), and letters of recommendation (2.45 ± 1.07 vs 3.14 ± 1.17; P = .04). Students particularly had a significant increase in the understanding of the logistics of residency interviews, which were held virtually that year for the first time (1.84 ± 0.96 vs 3.29 ± 1.20; P < .001). CONCLUSIONS: Virtual VSIG activities were feasible and effective during the pandemic in promoting student engagement and interest in vascular surgery. Despite lifting social distancing measures, the virtual format could become a valuable tool to expand outreach efforts of the vascular surgery community to recruit talented medical students.

The management of patients with popliteal artery aneurysms presenting with acute limb ischemia.

OBJECTIVE: Endovascular popliteal artery aneurysm (PAA) repair has acceptable outcomes compared with open repair for elective therapy. Endovascular repair for urgent PAA causing acute limb ischemia (ALI) has not been well-studied. This project compares outcomes of urgent endovascular and open repair of PAA with ALI. METHODS: The Vascular Quality Initiative database for peripheral vascular interventions (PVIs) and infrainguinal bypass were reviewed for PAAs with ALI from 2010 to 2021. Only patients entered as having symptoms of ALI in the PVI module and ALI as indication in the infrainguinal bypass module were included. In addition, patients undergoing elective treatment were excluded and the sample analyzed was restricted to patients undergoing urgent and emergent open and endovascular repair. Patient demographics and comorbidities as well as procedural details were compared between the two groups. Perioperative complications up to 30 days were compared as well as long-term outcomes including major amputation and mortality at 1 year. RESULTS: Urgent PAA repair for ALI constituted 10.5% (n = 571) of all PAAs. Most urgent repairs were open (80.6%; n = 460) with 19.4% (n = 111) endovascular. The proportion of endovascular repair significantly increased from 16.7% in 2010 to 85.7% in 2021. Patients undergoing endovascular repair were older (71.2 ± 12.5 vs 68.0 ± 11.8; P = .011) than patients undergoing open repair. They were also more likely to have coronary artery disease (32.4% vs 21.7%; P = .006). Open PAA repair was associated with more bleeding complications (20.8% vs 2.7%; P < .001), longer postoperative length of stay (8.1 ± 9.3 days vs 4.9 ± 5.6 days; P < .001), and less likelihood of discharge to home (64.9% vs 70.3%; P = .051). Perioperative major amputation rate was 7.5% with no difference between the two treatment strategies up to 1 year. However, patients receiving endovascular repair had higher inpatient (1.1% vs 0%; P < .001), 30-day (6.3% vs 0.4%; P < .001), and 1-year (16.5% vs 8.4%; P = .02) mortality. Multivariable regression analysis suggested that endovascular repair was possibly associated with increased 30-day mortality, but not 1-year mortality. CONCLUSIONS: Endovascular PAA has exponentially increased from 2010 to 2021. Endovascular repair is associated with decreased complications and hospital length of stay. The increased perioperative mortality seen in this group is likely due to selection bias.

Incidence and Significance of Deep Venous Reflux in Patients Treated with Saphenous Vein Ablation.

BACKGROUND: Venous ablation (VA) of the saphenous vein is the most common procedure performed for venous insufficiency. The incidence of concomitant deep venous reflux (DVR) in patients undergoing VA is unknown. Our hypothesis is that patients undergoing saphenous VA with concomitant DVR exhibit a higher clinical, etiology, anatomy, and pathophysiology (CEAP) stage and less relief after VA compared to patients without DVR. METHODS: Electronic medical records of patients treated with saphenous VA at a tertiary care center from March 2012 to June 2016 were reviewed. Patients were divided into 2 groups based on presence or absence of DVR on initial ultrasound (US) before saphenous VA. Patient characteristics and outcomes were compared. A telephone survey was conducted to assess long-term symptomatic relief, compliance with compression, and pain medication use. Subgroup analysis of patients with post-thrombotic versus primary DVR was performed. RESULTS: 362 patients underwent 497 ablations, and the incidence of DVR (>1 sec) was 20% (N = 71). Patients with DVR were significantly more likely to be male (46.4% vs. 32.1%, P = 0.021) and of Black race (21.2% vs. 5.5%, P = 0.0001) compared to patients without DVR. Patients with DVR were more likely to have a history of deep vein thrombosis (DVT) (15.1% vs. 7.9%, P = 0.045), but there was no difference in other comorbidities. There was no significant difference in presenting symptoms, CEAP stage, or symptom severity based on numeric rating scale (NRS) (0-10) for pain and swelling. Clinical success of saphenous VA was comparable between the 2 groups, but patients with DVR were more likely to develop endovenous heat-induced thrombosis (EHIT) II-IV (6% vs. 1%, P = 0.002). After a mean follow-up of 26 months, there was still no difference in pain or swelling scores, but patients with DVR were more likely to use compression stockings and used them more frequently. Only 11 of 71 patients with DVR had a history of DVT. Patients with post-thrombotic DVR were significantly older than patients with primary DVR (67.3 vs. 57.2, P = 0.038) and exhibited a trend toward more advanced venous disease (C4-C6: 45.4% vs. 33.3%, P = 0.439). CONCLUSIONS: In this study, 20% of patients undergoing saphenous VA demonstrated DVR, which was more common in Black men. Presence of DVR is associated with increased risk of EHIT after saphenous VA but does not seem to impact disease severity or clinical relief after ablation. Larger studies are needed to understand outcome differences between post-thrombotic and primary DVR.

Real-world antithrombotic treatment variability in patients undergoing peripheral vascular intervention: Insights from the VQI registry.

For those undergoing peripheral vascular interventions (PVI), guidelines indicate the use of dual antiplatelet therapy (DAPT) is reasonable (Class IIb), but recommendations have not reached the highest level of evidence. In the largest effort to date, we found that antithrombotic prescription was dominated by single antiplatelet therapy (SAPT) (51.4%) before PVI, which switched to DAPT (57.7%) following PVI, with some patients still remaining on no therapy (8%). High site variability in prescription rates (median odds ratio: 1.40, 95% confidence interval: 1.32, 1.48) was not much explained by patient and provider factors, revealing a need for the creation and integration of the newest trial data and for interventions at the health system or practice level to help physicians determine the optimal medical therapy following PVI.

Antiplatelet regimens following carotid artery revascularization.

Dual antiplatelet therapy (DAPT) is indicated following carotid artery stenting (CAS) and single antiplatelet therapy (SAPT) following carotid endarterectomy (CEA), but it remains unknown how providers adhere to these guidelines in real-world clinical practice. Using the Vascular Quality Initiative New England data, we found that of 12,257 patients, 82% patients were discharged on DAPT following CAS and 66% were discharged on SAPT following CEA. While a high percentage of patients undergoing CAS appropriately receive DAPT, the use of SAPT following CEA exists with more variability and lower adherence rates.

Real-world VASCADE closure device versus manual compression use and outcomes in patients with severe common femoral artery disease.

BACKGROUND: The VASCADE closure device deploys an extravascular collagen plug. Its use in those with access site disease undergoing peripheral vascular intervention (PVI) is unknown. We aimed to evaluate the efficacy and safety of the VASCADE closure device compared to manual compression (MC) in patients with moderate femoral access site disease. METHODS: We performed a single-center, retrospective review of patients undergoing PVI with at least moderate access site disease. Our institutional database was linked to the Vascular Quality Initiative database, and 200 patients were selected from a 1:1 propensity-matched cohort. Data on procedural metrics and outcomes up to 30-days were abstracted. RESULTS: There were 103 procedures that used VASCADE and 97 used MC. Baseline variables were similar between groups. The mean age was 68.2 ± 11.2 years and 37.6% were women. Closing mean activated clotting time (ACT) was shorter in VASCADE (198 s VASCADE vs. 213 s MC; p = 0.018). There was a nonsignificant decrease in external compression device use with VASCADE (VASCADE 19.0% vs. MC 28.1%; p = 0.15). At 30-days, there was a nonsignificant reduction in hematoma with VASCADE (3.8% vs. 7.8% MC; p = 0.25) and no difference in retroperitoneal bleeding (0.5%). Pseudoaneurysm rate was similar (1.3% VASCADE vs. 1.7% MC; p = 0.79). The 30-day mortality rate was similar between the two groups and not related to the procedure (1.3% VASCADE vs. 0.9% MC; p = 0.79). CONCLUSION: In patients undergoing PVI with at least moderate access site disease, safety and efficacy after using VASCADE was comparable with MC.

Eligibility of Patients with Chronic Limb Threatening Ischemia for Deep Venous Arterialization.

BACKGROUND: Percutaneous deep venous arterialization (pDVA) has emerged as a new modality for limb salvage in patients with chronic limb threatening ischemia (CLTI) and no standard option for revascularization. The proportion of patients facing major amputation who are eligible for this technology remains unknown. This study aims to provide a real-life estimate of patient eligibility for pDVA to reduce major amputations. METHODS: Electronic medical records of 100 consecutive patients with peripheral arterial disease (PAD) who underwent major amputation of 106 limbs were reviewed. Angiograms performed ≤6 months before amputation were assessed by two vascular surgeons. Disease severity was categorized using the Global Limb Anatomic Staging System (GLASS) and patients were classified as ideal, possible, or not candidates for pDVA. Ideal candidates had ≥1 patent tibial artery, no target in the foot, and no proximal disease. Possible candidates had ≥1 patent tibial artery with PAD, no target in the foot, and proximal disease amenable to endovascular therapy. Patients were not eligible if there was no patent tibial artery, extensive PAD, or an arterial target in the foot for bypass. RESULTS: Of 106 limbs reviewed, 35 (33%) did not undergo angiography ≤6 months before amputation because of infection (n = 14), advanced tissue loss (n = 10), failed revascularizations (n = 8), advanced limb ischemia (n = 2), and refusing revascularization (n = 1). Thus, 69 lower extremity angiograms (2 incomplete excluded) in 68 patients were analyzed. A total of 15 patients with 16 limbs (23.2%) were identified as candidates for pDVA (ideal = 7, possible = 9). There were no differences in demographics between the two groups, but candidates for pDVA were less likely to have hyperlipidemia and congestive heart failure than those who were not candidates. The pDVA candidates underwent significantly fewer interventions before major amputation compared to patients who were not candidates (1.50 ± 0.73 vs. 2.61 ± 2.57, P = 0.007). Angiographically, patients who were pDVA candidates had significantly higher Inframalleolar GLASS grades (1.81 ± 0.40 vs. 0.86 ± 0.41, P < 0.0001) but lower Femoropopliteal Glass grades (0.73 ± 1.10 vs. 2.43 ± 1.71, P < 0.0001) than patients who were not candidates. There was no significant difference in GLASS stage between these two groups (P = 0.368). After mean follow-up of 48 months, there was no difference in mortality between both groups (40% vs. 32.1%, P = 0.567). CONCLUSIONS: Among patients considered for revascularization, 23.2% had favorable angiography and 14.7% could have benefited for pDVA as a new therapeutic modality for limb salvage. 33% of major amputations were performed for clinically-deemed unsalvageable CLTI.

Lower Extremity Revascularization for Chronic Limb-Threatening Ischemia among Patients at the Extremes of Age.

BACKGROUND: Patients with chronic limb-threatening ischemia (CLTI) at the extremes of age are thought to have distinct risk factor profiles and poor outcomes after lower extremity revascularization (LER). The aim of this study is to examine the relationships among age, risk factor profiles, and outcomes of LER in patients with CLTI in a large database focusing on the extreme age groups. METHODS: Patients undergoing LER for CLTI in the Vascular Quality Initiative suprainguinal bypass, infrainguinal bypass, and peripheral vascular intervention files were reviewed through 2019. Patients were stratified into 3 groups: premature peripheral artery disease (PAD) (≤50 years old), 51-84 years old, and elderly (≥85 years old). Trends in major amputation and mortality by age group were analyzed. RESULTS: There were 156,513 patients who underwent LER for CLTI. Of these, 9,063 (5.79%) patients had premature PAD, 131,694 (84.14%) patients were 51-84 years old, and 15,756 (10.07%) were elderly. Patients with premature PAD were more likely to have insulin-dependent diabetes, be dialysis-dependent, and be active smokers compared to patients 51-84 years old and the elderly. Elderly patients were more likely to undergo an endovascular procedure for tissue loss compared to younger groups. Perioperative and 1-year major amputation rates were highest among patients with premature PAD and decreased with increasing age (P < 0.001), while perioperative and 1-year mortality increased with age (P < 0.001). On multivariable analysis, premature PAD was associated with an increased risk of major amputation (odds ratio, OR = 1.41 [1.22-1.62]), while elderly age was associated with decreased odds of major amputation compared to patients 51-84 years old (OR = 0.61 [0.51-0.73]). CONCLUSIONS: Patients at the extremes of age have significantly different outcomes after LER for CLTI. Although mortality increases with age, the risk of major amputation decreases. Patients with premature PAD constitute a group of patients with a high risk of perioperative and 1-year major amputation.

Cell therapy of critical limb ischemia-problems and prospects.

Cell therapy is proposed for indirect revascularization for the patient's incurable by endovascular or surgical revascularization. The therapy with stem cells (SCs) or progenitor cells is assumed to be more efficient as compared with protein or gene therapy not only because of their direct vasculogenic properties, but also thanks to their paracrine effect via secretion of manifold biologically active substances. This review gives an overview of the potential of SC-based therapy for critical limb ischemia (CLI), putative mechanism underlying cell therapy, and comparison of cell therapy to angiogenesis gene therapy in CLI treatment. Human trial data and meta-analysis, as well as some problems of clinical trials and considerations for future SC-based therapy in CLI are also discussed.

Modelling lower-limb peripheral arterial disease using clinically available datasets: impact of inflow boundary conditions on hemodynamic indices for restenosis prediction.

BACKGROUND AND OBJECTIVES: The integration of hemodynamic markers as risk factors in restenosis prediction models for lower-limb peripheral arteries is hindered by fragmented clinical datasets. Computed tomography (CT) scans enable vessel geometry reconstruction and can be obtained at different times than the Doppler ultrasound (DUS) images, which provide information on blood flow velocity. Computational fluid dynamics (CFD) simulations allow the computation of near-wall hemodynamic indices, whose accuracy depends on the prescribed inlet boundary condition (BC), derived from the DUS images. This study aims to: (i) investigate the impact of different DUS-derived velocity waveforms on CFD results; (ii) test whether the same vessel areas, subjected to altered hemodynamics, can be detected independently of the applied inlet BC; (iii) suggest suitable DUS images to obtain reliable CFD results. METHODS: CFD simulations were conducted on three patients treated with bypass surgery, using patient-specific DUS-derived inlet BCs recorded at either the same or different time points than the CT scan. The impact of the chosen inflow condition on bypass hemodynamics was assessed in terms of wall shear stress (WSS)-derived quantities. Patient-specific critical thresholds for the hemodynamic indices were applied to identify critical luminal areas and compare the results with a reference obtained with a DUS image acquired in close temporal proximity to the CT scan. RESULTS: The main findings indicate that: (i) DUS-derived inlet velocity waveforms acquired at different time points than the CT scan led to statistically significantly different CFD results (p<0.001); (ii) the same luminal surface areas, exposed to low time-averaged WSS, could be identified independently of the applied inlet BCs; (iii) similar outcomes were observed for the other hemodynamic indices if the prescribed inlet velocity waveform had the same shape and comparable systolic acceleration time to the one recorded in close temporal proximity to the CT scan. CONCLUSIONS: Despite a lack of standardised data collection for diseased lower-limb peripheral arteries, an accurate estimation of luminal areas subjected to altered near-wall hemodynamics is possible independently of the applied inlet BC. This holds if the applied inlet waveform shares some characteristics - derivable from the DUS report - as one matching the acquisition time of the CT scan.

Endovascular fenestration and iliac stenting for acute limb ischemia caused by type B aortic dissection.

A 60-year-old man presented with chest pain and acute limb ischemia of the right leg. He was found to have a type B aortic dissection with a flap occluding the origin of the right common iliac artery. The dissection flap was fenestrated endovascularly with the placement of a covered stent in the right common iliac artery. After 10 years, the dissection remains stable with a minimal increase in the aorta size. The stent is patent with no lower extremity symptoms or reintervention. Fenestration and stenting of the obstructing flap can be a durable reperfusion strategy for patients with aortic dissection presenting with acute limb ischemia.

Balloon rupture with eversion during innominate vein angioplasty requiring surgical retrieval.

Balloon rupture during angioplasty can with calcified or recalcitrant lesions. A 61-year-old woman presented with worsening arm and facial swelling. She had a history of left upper extremity thrombolysis and stenting of the innominate vein 6 years prior. Venography showed severe in-stent stenosis. After crossing the lesion, a 12-mm balloon was inflated, which ruptured at nominal pressure. The balloon became stuck and could not be moved over the wire even after retraction of the sheath. A limited surgical cutdown was performed, and the balloon and the wire were removed together. The ruptured balloon part was found to be everted and circumferentially wrapped around the wire, preventing the wire exchange. After cutting the everted portion of the balloon, the catheter was removed without losing wire access. A high-pressure balloon was subsequently used to treat the lesion successfully. Her symptoms had resolved on follow-up, and the stent remained patent after 6 months.

A narrative review on the application of high-intensity focused ultrasound for the treatment of occlusive and thrombotic arterial disease.

Objectives: High-intensity focused ultrasound (HIFU) is a noninvasive therapeutic modality with a variety of applications. It is approved for the treatment of essential tremors, ablation of prostate, hepatic, breast, and uterine tumors. Although not approved for use in the treatment of atherosclerotic arterial disease, there is a growing body of evidence investigating applications of HIFU. Currently, percutaneous endovascular techniques are predominant for the treatment of arterial pathology; however, there are no endovascular techniques of HIFU available. This study aims to review the state of current evidence for the application of HIFU in atherosclerotic arterial disease. Methods: All English-language articles evaluating the effect of HIFU on arterial occlusive and thrombotic disease until 2021 were reviewed. Both preclinical and human clinical studies were included. Study parameters such as animal or clinical model and outcomes were reviewed. In addition, details pertaining to settings on the HIFU device used were also reviewed. Results: In preclinical models, atherosclerotic plaque progression was inhibited by HIFU, through decreases in oxidized low-density lipoprotein cholesterol and increases in macrophage apoptosis. Additionally, HIFU promotes angiogenesis in hindlimb ischemic models by the upregulation of angiogenic and antiapoptotic factors, with increased angiogenesis at higher line densities of HIFU. HIFU also promotes thrombolysis and conversely induces platelet activation at low frequencies and higher intensities. Various clinical studies have attempted to translate some of these properties and demonstrated positive clinical outcomes for arterial recanalization after thrombotic stroke, decreased atherosclerotic plaque burden in carotid arteries, increase in tissue perfusion and a decrease in diameter stenosis in patients with atherosclerotic arterial disease. Conclusions: In current preclinical and clinical data, the safety and efficacy of HIFU shows great promise in the treatment of atherosclerotic arterial disease. Future focused studies are warranted to guide the refinement of HIFU settings for more widespread adoption of this technology.

Establishment of a definitive protocol for the diagnosis and management of body packers (drug mules).

BACKGROUND: 'Mules' or body packers are people who transport illegal drugs by packet ingestion into the gastrointestinal tract. These people are otherwise healthy and their management should maintain minimal morbidity. In this study, experience with body packers is presented and an algorithm for conservative and surgical management is provided. METHODS: The clinical patient database for all body packer admissions at Mary Immaculate Hospital of the Caritas Health Care Inc. from 1993 to 2005 was interrogated. 56 patients (4.5%) required admission out of a total of 1250 subjects confirmed to be body packers and apprehended by United State Customs officials at JFK International Airport, New York. The retrieved patient data were analysed retrospectively. RESULTS: 70% of the body packers were men, with a male to female ratio of 2.8 to 1. The mean age was 33 years and 52% were from Columbia. Heroin was the most common illegally transported substance (73%). 25 patients (45%) required surgical intervention, whereas 31 patients (55%) were successfully managed conservatively. Indications for intervention included: bowel obstruction, packet rupture/toxicity, and delayed progression of packet transit on conservative management. Multiple intraoperative manoeuvres were used to remove the foreign bodies: gastrotomy, enterotomy and colotomy. Wound infection was the most common complication and is associated with distal enterotomy and colotomy. CONCLUSIONS: Men were more likely to present as body packers than women. Proximal enterotomies are preferred and multiple enterotomies should be avoided. A confirmatory radiological study is needed to demonstrate complete clearance of packets. A systematic protocol for the management of body packers results in minimal morbidity and no mortality.