Risk of Stroke, Death, and Myocardial Infarction Following Transcarotid Artery Revascularization vs Carotid Endarterectomy in Patients With Standard Surgical Risk.

Importance: Carotid artery stenting has been limited to use in patients with high surgical risk; outcomes in patients with standard surgical risk are not well known. Objective: To compare stroke, death, and myocardial infarction outcomes following transcarotid artery revascularization vs carotid endarterectomy in patients with standard surgical risk. Design, Setting, and Participants: This retrospective propensity-matched cohort study was conducted from August 2016 to August 2019 with follow-up until August 31, 2020, using data from the multicenter Vascular Quality Initiative Carotid Artery Stent and Carotid Endarterectomy registries. Patients with standard surgical risk, defined as those lacking Medicare-defined high medical or surgical risk characteristics and undergoing transcarotid artery revascularization (n = 2962) or carotid endarterectomy (n = 35 063) for atherosclerotic carotid disease. In total, 760 patients were excluded for treatment of multiple lesions or in conjunction with other procedures. Exposures: Transcarotid artery revascularization vs carotid endarterectomy. Main Outcomes and Measures: The primary outcome was a composite end point of 30-day stroke, death, or myocardial infarction or 1-year ipsilateral stroke. Results: After 1:3 matching, 2962 patients undergoing transcarotid artery revascularization (mean [SD] age, 70.4 [6.9] years; 1910 [64.5%] male) and 8886 undergoing endarterectomy (mean [SD] age, 70.0 [6.5] years; 5777 [65.0%] male) were identified. There was no statistically significant difference in the risk of the primary composite end point between the 2 cohorts (transcarotid 3.0% vs endarterectomy 2.6%; absolute difference, 0.40% [95% CI, -0.43% to 1.24%]; relative risk [RR], 1.14 [95% CI, 0.87 to 1.50]; P = .34). Transcarotid artery revascularization was associated with a higher risk of 1-year ipsilateral stroke (1.6% vs 1.1%; absolute difference, 0.52% [95% CI, 0.03 to 1.08]; RR, 1.49 [95% CI, 1.05 to 2.11%]; P = .02) but no difference in 1-year all-cause mortality (2.6% vs 2.5%; absolute difference, -0.13% [95% CI, -0.18% to 0.33%]; RR, 1.04 [95% CI, 0.78 to 1.39]; P = .67). Conclusions and Relevance: In this study, the risk of 30-day stroke, death, or myocardial infarction or 1-year ipsilateral stroke was similar in patients undergoing transcarotid artery revascularization compared with those undergoing endarterectomy for carotid stenosis.

Systematic review of hemostatic agents used in vascular surgery.

BACKGROUND: Hemostatic agents are routinely used in vascular surgery to complement proper suture techniques and decrease the risk of perioperative bleeding. A relative lack of comparative research studies have left surgeons with the option of choosing hemostatic agents based on their personal experience. The present review has highlighted the efficacy and safety of hemostatic agents and categorized them according to their primary mechanism of action and cost. METHODS: A systematic search strategy encompassing hemostatic agent products was deployed in the PubMed database. Single-center and multicenter, randomized, controlled trials with >10 patients were included in the present study. RESULTS: We reviewed 12 studies on the efficacy and safety of hemostatic agents compared with manual compression or other hemostatic agents. Using the time to hemostasis as the primary end point, all studies had found hemostatic agents to be significantly more efficient than manual compression. Likewise, adhesives (high pressure sealants) and dual agents (containing biologically active and absorbable components) were found to be more efficient, but costlier, than agents with either biologically active or absorbable components only. Agents with porcine or bovine constituents were found to trigger anaphylactic reactions in rare cases. Additionally, the absence of fibrin stabilizing factor XIII in a brand of fibrin sealant was speculated to reduce the affinity of the fibrin sealant for the expanded polytetrafluoroethylene graft. The cost of agents varied greatly depending on their active ingredient. CONCLUSIONS: Hemostatic agents appear to be highly effective at decreasing the risk of bleeding during surgical procedures. Although some hemostatic agents were demonstrated to achieve hemostasis faster than others, most are able to control bleeding within <10 minutes. Based on the limited data, the least expensive agents might suffice for limited suture lines used in routine procedures.

Public Health Impact of the Centers for Medicare and Medicaid Services Decision on Pass-Through Add-On Payments for Drug-Coated Balloons: A Call to Action.

On Wednesday, November 1, 2017, the Centers for Medicare and Medicaid Services (CMS) made a public decision to end the transitional pass-through add-on payment for drug-coated balloons beginning January 1, 2018, without creating a new ambulatory payment classification rate for these devices. In this Viewpoint, the authors highlight the disconnect between the CMS's decision not to create a new ambulatory payment classification category for drug-coated balloons despite demonstrated clinical superiority. The authors believe this decision is more in line with a rigid fee-for-service payment system than a value-based system that encourages quality over quantity, and disadvantages both the elderly and the poor. They call on all who advocate for patients with peripheral artery disease to action, encouraging their engagement on CMS decisions regarding payment.

Carotid occlusion is associated with more frequent neurovascular events than moderately severe carotid stenosis.

OBJECTIVE: Asymptomatic internal carotid artery occlusion (CO) presents a clinical dilemma, and presently, the natural history, stroke risk, and optimal management remain ill defined. This study compared outcomes, including neurovascular events (NVEs) and health care costs, between patients with CO and patients with asymptomatic carotid artery stenosis (CS). METHODS: A prospectively maintained database was queried to identify patients with CO and CS with at least >50% carotid stenosis by duplex. We identified and reviewed 622 consecutive patients with asymptomatic carotid artery disease at one academic medical center between 2011 and 2013. Patients with CO (n = 97) were identified and propensity matched by age and gender in a 1:2 ratio with CS patients (n = 194) for further analyses. Univariate and multivariate models were used to analyze baseline characteristics, clinical variables, and 1-year follow-up data from the date of diagnosis. Multivariate analysis was performed by multiple linear regression modeling. Institutional Review Board approval was obtained. RESULTS: Follow-up data were available for 99% of matched patients. CO patients were younger (72 vs 75 years; P < .01) and more likely male (67% vs 53%; P = .01) compared with CS patients. After propensity matching, baseline characteristics were similar between groups, with a trend toward higher use of statin therapy among patients with CO. Antiplatelet therapy was used in 79% of patients with CS and in 74% of patients with CO (P = .45). The rate of NVE among CO patients was higher than among CS patients at 1 year of follow-up (14% vs 7%; P = .03). Among those with NVE, neither antiplatelet therapy (64% vs 77%; P = .49) nor statin therapy (86% vs 77%; P = .58) appeared to have a significant effect. Health care costs ($14,361 vs $12,142; P = .44) and hospital admission rate (63% vs 71%; P = .18) were similar between groups. Not surprisingly, the rate of vascular procedures was higher in the CS group (55% vs 27%; P = .04). CONCLUSIONS: Patients with asymptomatic CO experience more NVEs compared with similar patients with moderately severe CS. Further study of preventative strategies, including intensity of medical therapy, is warranted.

Cost awareness decreases total percutaneous coronary intervention procedural cost: The SHOPPING (Show How Options in Price for Procedures Can Be Influenced Greatly) trial.

OBJECTIVES: We initiated the SHOPPING Trial (Show How Options in Price for Procedures can be InflueNced Greatly) to see if percutaneous coronary intervention (PCI) procedures can be performed at a lower cost in a single institution. BACKGROUND: Procedural practice variability is associated with inefficiency and increased cost. We hypothesized that announcing costs for all supplies during a catheterization procedure and reporting individual operator cost relative to peers would spur cost reduction without affecting clinical outcomes. METHODS: Baseline costs of 10 consecutive PCI procedures performed by 9 interventional cardiologists were documented during a 90-day interval. Costs were reassessed after instituting cost announcing and peer reporting the next quarter. The intervention involved labeling of all endovascular supplies, equipment, devices, and disposables in the catheterization laboratory and announcement of the unit price for each piece when requested. For each interventionalist, procedure time and costs were measured and analyzed prior to and after the intervention. RESULTS: We found that total PCI procedural cost was significantly reduced by an average of $234.77 (P = 0.01), equating to a total savings of $21,129.30 over the course of 90 PCI procedures. Major Adverse Cardiac and Cerebrovascular Event (MACCE) rates were similar during both periods (2.3% vs. 3.5%, P = NS). CONCLUSIONS: Announcing costs in the catheterization laboratory during single vessel PCI and peer reporting leads to cost reduction without affecting clinical outcomes. This intervention may have a role in more complex coronary and peripheral interventional procedures, and in other procedural areas where multiple equipment and device alternatives with variable costs are available. © 2016 Wiley Periodicals, Inc.

In vivo assessment of endothelial function in human lower extremity arteries.

OBJECTIVE: Endothelial function has been measured in preclinical studies in human brachial and coronary arteries but not in lower extremity arteries affected by atherosclerosis. We describe a novel, first-in-man evaluation of endothelial function of the superficial femoral arteries (SFAs) in patients with peripheral arterial disease (PAD). METHODS: Enrolled were 25 patients with PAD requiring lower extremity angiography. Endothelial-dependent relaxation was measured using intravascular ultrasound (IVUS) imaging and a Doppler flow wire after the infusion of acetylcholine (Ach). IVUS-derived virtual histology of the same vessel was calculated. Endothelial-independent relaxation was measured with an infusion of nitroglycerin (200 µg). Levels of nitric oxide and serum nitric oxide metabolites were determined by laboratory analysis. RESULTS: Patients (48% male; mean age, 62 years) had a history of hypertension (80%), coronary disease (36%), and diabetes (40%). The mean SFA diameter was 5.2 ± 1 mm (range, 3.2-6.9 mm). Patients tolerated Ach infusion with no adverse events. Endothelial-dependent relaxation increased over baseline for all patients with Ach infusion of 10(-6) to 10(-4). At Ach 10(-4), diameter (0.5%) and area (1.8%) changes in the diseased SFAs were modest and insignificant; however, average peak velocity of blood flow significantly increased 26%, 46%, and 63% with an Ach 10(-6) to 10(-4) infusion. Calculations of limb volumetric flow (68% at Ach 10(-4)) were significantly increased after Ach infusion. Lower extremity nitric oxide levels were slightly lower than systemic venous levels (P = .04). Nitroglycerin infusion indicated normal smooth muscle responsiveness (3% diameter, 9% area, and 116% velocity change over baseline). IVUS-virtual histology plaque stratification indicated predominantly fibrous morphology (46%; necrotic core, 29%; calcium, 18%). Atheroma burden was 14.9 ± 5.5 mm(3)/cm and did not correlate with endothelial responsiveness. CONCLUSIONS: Endothelial function can be measured directly in human lower extremity arteries at the sites of vascular disease. Despite extensive atherosclerosis, endothelial function is still intact. These data support the application of regional endothelial-specific biologic therapies in patients with PAD.

Prescribing patterns of antiplatelet agents are highly variable after lower extremity endovascular procedures.

BACKGROUND: The use of antiplatelet and antithrombotic agents after peripheral vascular interventions is a common clinical practice despite a lack of clear convincing evidence or accepted practice guidelines. The goal of this study was to assess surgeons' prescribing practices after endovascular procedures for lower extremity arterial occlusive disease. METHODS: Attendees at a national vascular meeting were asked to complete a voluntary survey indicating their prescribing practices of antiplatelet/antithrombotic agents for the following procedures: iliac bare-metal stent, iliac covered stent, infrainguinal balloon angioplasty, infrainguinal bare-metal stent, infrainguinal covered stent, infrainguinal atherectomy, and lower extremity cryoplasty. The respondents were given choices of aspirin (ASA) alone, clopidogrel alone, ASA/clopidogrel combined, warfarin alone, or ASA/clopidogrel/warfarin combined. They were also asked to indicate their preferred length of treatment for each medication or combination of medications for each procedure: 1, 3, 6, or 12 months. RESULTS: There were 51 respondents (48 vascular surgeons and 3 vascular fellows) with an average of 11 ± 6.4 years of experience and practicing in a university hospital (48%), community hospital (44%), or combined university/Veterans A hospital (6%) setting. The majority of respondents (98%) prescribe an antiplatelet agent for patients with peripheral arterial disease using 81 mg of ASA preferentially. Most surgeons do not obtain genetic testing (i.e., cytochrome P450, polypeptide 19 [CYP2C19] polymorphism) for antiplatelet effectiveness. The most common antiplatelet/antithrombotic medication of choice after lower extremity endoluminal therapy was a combination of ASA/clopidogrel. However, the duration of medical treatment was variable, with a 1- to 3-month course being the most common. The use of the ASA/clopidogrel combination increased with further distal endovascular treatment and the placement of stents versus angioplasty. In the vast majority of ASA-only responses, ASA was administered for at least 12 months if not recommended for life. Although the majority of surgeons would recommend dual antiplatelet therapy (52-77%), there was no consensus regarding the duration of treatment. CONCLUSIONS: The antiplatelet/antithrombotic prescribing practices of vascular surgeons after lower extremity endovascular procedures are highly variable. Multicenter randomized controlled trials are needed to define optimal treatment efficacy and define the much-needed practice guidelines.

The contemporary management of splenic artery aneurysms.

OBJECTIVES: The management of patients with splenic artery aneurysms (SAAs) is variable since the natural history of these aneurysms is poorly delineated. The objective of this study was to review our experience with open repair, endovascular therapy, and observation of SAAs over a 14-year interval. METHODS: Between January 1, 1996 and December 31, 2009, 128 patients with SAAs were evaluated. Sixty-two patients underwent surgical repair (n = 13) or endovascular coil/glue ablation (n = 49), while 66 patients underwent serial observation. The original medical records and computed tomography (CT) imaging were reviewed. Statistical analyses were performed using χ(2) or Fisher's exact test for categorical patient characteristics and t-test for continuous variables. Kaplan-Meier estimates for survival were calculated. Mortality was verified via the Social Security Death Index. RESULTS: Patients (61 ± 11 years, 69% female) were investigated for abdominal symptoms (49%) or had the incidental finding of SAA (mean size, 2.4 ± 1.4 cm). Seven patients (5.5%) presented with rupture and were treated emergently with two perioperative mortalities (29%). Patients requiring surgical or endovascular treatment were more likely male (40% vs 21%, P = .031), younger (58 vs 64 years; P = .004), and current smokers (18% vs 5%; P = .035). Increased aneurysm calcification was associated with decreased SAA size (P = .013). The mean aneurysm size at initial diagnosis was 1.67 cm for patients undergoing observation and 3.13 cm for the treated group (P < .001). Endovascular repair was safe and durable with a mean 1.5-mm regression in SAA size over 2 years. The mean rate of growth for observed SAA was 0.2 mm/y. Ten-year survival was 89.4% (95% confidence interval: 82.0, 97.4) for all patients (observed group, 94.9%; treated group, 85.1%; P = .18). No late aneurysm-related mortality was identified. CONCLUSIONS: Ruptured SAAs are lethal. Large SAAs can undergo endovascular ablation safely with durable SAA regression. Smaller SAAs (<2 cm) grow slowly and carry a negligible rupture risk.

The management of severe aortoiliac occlusive disease: endovascular therapy rivals open reconstruction.

OBJECTIVE: Aortobifemoral bypass (ABF) grafting has been the traditional treatment for extensive aortoiliac occlusive disease (AIOD). This retrospective study compared the outcomes and durability of recanalization, percutaneous transluminal angioplasty, and stenting (R/PTAS) vs ABF for severe AIOD. METHODS: Between 1998 and 2004, 86 patients (161 limbs) underwent ABF (n = 75) or iliofemoral bypass (n = 11), and 83 patients (127 limbs) underwent R/PTAS. All patients had severe symptomatic AIOD (claudication, 53%; rest pain, 28%; tissue loss, 12%; acute limb ischemia, 7%). The analyses excluded patients treated for aneurysms, extra-anatomic procedures, and endovascular treatment of iliac stenoses. Original angiographic imaging, medical records, and noninvasive testing were reviewed. Kaplan-Meier estimates for patency and survival were calculated and univariate analyses performed. Mortality was verified by the Social Security database. RESULTS: The ABF patients were younger than the R/PTAS patients (60 vs 65 years; P = .003) and had higher rates of hyperlipidemia (P = .009) and smoking (P < .001). All other clinical variables, including cardiac status, diabetes, symptoms at presentation, TransAtlantic Inter-Society Consensus stratification, and presence of poor outflow were similar between the two groups. Patients underwent ABF with general anesthesia (96%), often with concomitant treatment of femoral or infrainguinal disease (61% endarterectomy, profundaplasty, or distal bypass). Technical success was universal, with marked improvement in ankle-brachial indices (0.48 to 0.84, P < .001). Patients underwent R/PTAS with local anesthesia/sedation (78%), with a 96% technical success rate and similar hemodynamic improvement (0.36 to 0.82, P < .001). At the time of R/PTAS, 21% of patients underwent femoral endarterectomy/profundaplasty or bypass (n = 5) for concomitant infrainguinal disease. Limb-based primary patency at 3 years was significantly higher for ABF than for R/PTAS (93% vs 74%, P = .002). Secondary patency rates (97% vs 95%), limb salvage (98% vs. 98%), and long-term survival (80% vs 80%) were similar. Diabetes mellitus and the requirement of distal bypass were associated with decreased patency (P < .001). Critical limb ischemia at presentation (tissue loss, hazard ratio [HR], 8.1; P < .001), poor outflow (HR, 2; P = .023), and renal failure (HR, 2.5; P = .02) were associated with decreased survival. CONCLUSION: R/PTAS is a suitable, less invasive alternative to ABF for the treatment of severe AIOD. Repair of the concomitant femoral occlusive disease is often needed regardless of open or endovascular treatment. Infrainguinal disease negatively affects the durability of the procedure and patient survival.

Trends in endovascular surgery training.

PURPOSE: To gather vascular surgery fellows' opinions on various issues related to endovascular surgery (EVS) over a 2-year period and analyze the responses to identify trends in EVS training. METHODS: Vascular surgery fellows in 2 consecutive years were given a 2-page questionnaire inquiring about training protocols and local practice habits. Respondents included 64 vascular fellows from the academic year 1998-1999 (F98) and 52 vascular fellows from the academic year 1999-2000 (F99) (78% men in the entire population; mean age 34 years), representing a significant fraction of trainees in North America. Data from F98 and F99 were compared and analyzed. RESULTS: The majority (66%) of vascular surgery fellows were trained at university hospitals and performed EVS at the time of the survey: 83% in the F98 class and 92% in the F99 group (p=0.17). Utilization rates among the 9 interventions surveyed ranged from angiography (83%) and angioplasty (77%) to intravascular ultrasound (33%) and atherectomy (15%). Performance of endovascular grafting significantly increased among trainees (50% versus 81%, p<0.005), while atherectomy and angioscopy decreased. EVS performed in the operating room with portable imaging equipment decreased (67% versus 42%, p=0.02) as access to the radiology and cardiology suites increased. In most communities (63%), radiology specialists performed most of the EVS procedures, but the portion of communities where vascular surgery performed the majority of EVS procedures increased from 20% to 35% (p=0.10) from F98 to F99. Responders (90%) believed that EVS would become a major component of vascular surgery and comprise 30% of their future practice. The proportion of fellows who believed they were sufficiently trained in endovascular techniques increased from 30% to 50% (p=0.04), with the remainder willing to devote a short period (<3 months) for further training. CONCLUSIONS: The vast majority of vascular trainees perform EVS and believe that it will have an increasing role in their practice. Trends include increased endovascular grafting and performance of EVS by vascular surgeons in interventional suites.