A Comparison of Venaseal Versus Radiofrequency Ablation Outcomes Within a Managed Care Organization.

BACKGROUND: Chronic venous insufficiency is a common medical condition that afflicts over 30 million adults in the United States. Treatment and management have changed dramatically over the past 20 years with the introduction of various endovenous therapies, including radiofrequency ablation (RFA) and cyanoacrylate closure using the Venaseal system. In this study, we explore a direct comparison of outcomes between RFA and VenaSeal conducted by a single surgeon within a managed care organization. METHODS: Between May 2020 and December 2021, there were 87 patients undergoing 97 total procedures who were treated with either VenaSeal (n = 55) or RFA (n = 42), conducted by a single surgeon within a managed care organization. Primary outcomes included successful greater saphenous vein (GSV) closure, postoperative deep vein thrombosis (DVT), embolization, saphenofemoral junction (SFJ) thrombosis, skin reaction (allergic or thrombophlebitis), or procedure-related emergency room (ER) and urgent care (UC) visits. Retrospective chart review was conducted to describe patient demographics, indications for treatment, treatment details (number of access sites and indication for treatment), as well as follow-up adjunctive vein procedures (sclerotherapy and stab phlebectomy). RESULTS: All patients had postprocedural ultrasound (US) performed within 7 days by the operating surgeon and mean overall patient follow-up from index procedure was 12 months; 2 patients were lost to follow-up due to death. All operations utilized intraoperative US, and SFJ thrombosis was not observed in any patient postprocedure. The average age of VenaSeal and RFA groups was 59.05 and 59.51 years, respectively. The average number of access sites during the procedure for VenaSeal and RFA was 1.56 and 1.20, respectively. Of the 55 VenaSeal treatments, 9.1% of patients reported postoperative skin reactions, and 9.1% of patients underwent subsequent stab phlebectomy (22 stabs on average). Of the 42 RFA treatments, 7.1% of RFA patients reported postoperative skin reactions, and 9.5% underwent subsequent stab phlebectomy (36 stabs on average). The percentage of patients who had postoperative UC or emergency department visits related to the procedure in the VenaSeal and RFA groups was 3.6% and 0%, respectively. CONCLUSIONS: Both VenaSeal and RFA demonstrated effective vein closure of the GSV at 12-month follow-up, with VenaSeal demonstrating continued noninferiority to RFA. Based on our data, postoperative skin reactions do not appear to be significantly higher with VenaSeal treatment, as previously reported.

COVID-19-related Peripheral Arterial Thrombosis Treated in a Large Health Maintenance Organization.

BACKGROUND: COVID-19 was initially identified as an acute respiratory disease, but it was quickly recognized that multiple organ systems could be affected. Venous thrombosis and pulmonary embolism have been well reported. However, there is a paucity of data on COVID-19-related arterial thrombosis. We examined the incidence, characteristics, treatment, and outcome in patients with acute COVID-19-related arterial thrombosis in a large health maintenance organization (HMO). METHODS: A retrospective multicenter case review was performed from March 2020 to March 2021. Cases were identified through a questionnaire sent to vascular surgeons. Patient characteristics, imaging, treatment, and outcome were reviewed. Successful revascularization was defined as restoration of blood flow with viability of the end organ and absence of death within 30 days. Limb salvage was defined as prevention of major amputation (transtibial or transfemoral) and absence of death in 30 days. RESULTS: There were 37,845 patients admitted with COVID-19 complications during this time. Among this group, 26 patients (0.07%) had COVID-19-related arterial thrombosis. The mean age was 61.7 years (range, 33-82 years) with 20 men (77%) and 6 women (23%). Ethnic minorities comprised 25 of 26 cases (96%). Peripheral arterial disease (PAD) was present in 4 of 26 (15%), active smoking in 1 of 26 (3.8%), and diabetes in 19 of 26 (73%) cases. Most patients developed acute arterial ischemia in the outpatient setting, 20 of 26 (77%). Of the outpatients, 6 of 20 (30%) had asymptomatic COVID-19 and 14 of 20 (70%) had only mild upper respiratory symptoms. Distribution of ischemia was as follows: 23 patients had at least one lower extremity ischemia, one patient had cerebral and lower extremity, one had mesenteric and lower extremity, and one had upper extremity ischemia. Revascularization was attempted in 21 patients, of which 12 of 21 (57%) were successful. Limb salvage was successful in 13 of 26 (50%) patients. The overall mortality was 31% (8/26). CONCLUSIONS: Our experience in a large HMO revealed that the incidence of COVID-19-related arterial thrombosis was low. The actual incidence is likely to be higher since our method of case collection was incomplete. The majority of arterial thrombosis occurred in the outpatient setting in patients with asymptomatic or mild/moderate COVID-19 respiratory disease. Acute ischemia was the inciting factor for hospitalization in these cases. Acute lower extremity ischemia was the most common presentation, and limb salvage rate was lower than that expected when compared to ischemia related to PAD. Arterial thrombosis associated with COVID-19 portends a significantly higher mortality. Education of primary care providers is paramount to prevent delayed diagnosis as most patients initially developed ischemia in the outpatient setting and did not have a high cardiovascular risk profile.

Cost-effectiveness of dehydrated human amnion/chorion membrane allografts in lower extremity diabetic ulcer treatment.

OBJECTIVE: To evaluate the cost-effectiveness and budget impact of using standard care (no advanced treatment, NAT) compared with an advanced treatment (AT), dehydrated human amnion/chorion membrane (DHACM), when following parameters for use (FPFU) in treating lower extremity diabetic ulcers (LEDUs). METHOD: We analysed a retrospective cohort of Medicare patients (2015-2019) to generate four propensity-matched cohorts of LEDU episodes. Outcomes for DHACM and NAT, such as amputations, and healthcare utilisation were tracked from claims codes, analysed and used to build a hybrid economic model, combining a one-year decision tree and a four-year Markov model. The budget impact was evaluated in the difference in per member per month spending following completion of the decision tree. Likewise, the cost-effectiveness was analysed before and after the Markov model at a willingness to pay (WTP) threshold of $100,000 per quality adjusted life year (QALY). The analysis was conducted from the healthcare sector perspective. RESULTS: There were 10,900,127 patients with a diagnosis of diabetes, of whom 1,213,614 had an LEDU. Propensity-matched Group 1 was generated from the 19,910 episodes that received AT. Only 9.2% of episodes were FPFU and DHACM was identified as the most widely used AT product among Medicare episodes. Propensity-matched Group 4 was limited by the 590 episodes that used DHACM FPFU. Episodes treated with DHACM FPFU had statistically fewer amputations and healthcare utilisation. In year one, DHACM FPFU provided an additional 0.013 QALYs, while saving $3,670 per patient. At a WTP of $100,000 per QALY, the five-year net monetary benefit was $5003. CONCLUSION: The findings of this study showed that DHACM FPFU reduced costs and improved clinical benefits compared with NAT for LEDU Medicare patients. DHACM FPFU provided better clinical outcomes than NAT by reducing major amputations, ED visits, inpatient admissions and readmissions. These clinical gains were achieved at a lower cost, in years 1-5, and were likely to be cost-effective at any WTP threshold. Adoption of best practices identified in this retrospective analysis is expected to generate clinically significant decreases in amputations and hospital utilisation while saving money.

Percutaneous Axillary Artery Access for Peripheral and Complex Endovascular Interventions: Clinical Outcomes and Cost Benefits.

OBJECTIVES: The aim of this study was to determine the safety, efficacy, and applicability of percutaneous axillary artery (pAxA) access in patients requiring upper extremity large sheath access during complex aortic, cardiac, and peripheral endovascular procedures. We also take this opportunity to address the potential cost-benefits offered by pAxA access compared to open upper extremity access. METHODS: A total of 26 consecutive patients, between June 2018 and October 2020, underwent endovascular intervention, requiring upper extremity access (UEA). Ultrasound-guided, percutaneous access of the axillary artery was used in all 26 patients with off-label use of pre-close technique with Perclose ProGlide closure devices. Access sites accommodated sheath sizes that ranged from 6 to 14 French (F). End points were technical success and access site-related complications including isolated neuropathies, hematoma, distal embolization, access-site thrombosis, and post-operative bleeding requiring secondary interventions. Technical success was defined as successful arterial closure intraoperatively with no evidence of stenosis, occlusion, or persistent bleeding, requiring additional intervention. RESULTS: Of the 26 patients requiring pAxA access, 15 underwent complex endovascular aortic aneurysm repairs (EVAR) with branched, fenestrated, snorkel, or parallel endografts, 6 underwent peripheral vascular interventions, and 5 underwent cardiac interventions. Fifty-three percent accommodated sheath sizes of 12F or higher. Technical success was achieved in 100% of cases with no major perioperative access complications requiring additional open or endovascular procedures. In our series, we had one post-operative mortality secondary to myocardial infarction in a patient with significant coronary artery disease. CONCLUSIONS: Our data again demonstrated the proposed safety and efficacy attributable to pAxA access, while extending its application to wide spectrum of endovascular interventions which included peripheral or coronary vascular in addition to complex EVAR.

Observed impact of skin substitutes in lower extremity diabetic ulcers: lessons from the Medicare Database (2015-2018).

OBJECTIVE: To evaluate large propensity-matched cohorts to assess outcomes in patients receiving advanced treatment (AT) with skin substitutes for lower extremity diabetic ulcers (LEDUs) versus no AT (NAT) for the management of LEDUs. METHOD: The Medicare Limited Dataset (1 October 2015 through 2 October 2018) were used to retrospectively analyse people receiving care for a LEDU treated with AT or NAT (propensity-matched Group 1). Analysis included major and minor amputations, emergency department (ED) visits and hospital readmissions. In addition, AT following parameters for use (FPFU) was compared with AT not FPFU (propensity-matched Group 2). A paired t-test was used for comparisons of the two groups. For comparisons of three groups, the Kruskal-Wallis test was used. A Bonferroni correction was performed when multiple comparisons were calculated. RESULTS: There were 9,738,760 patients with a diagnosis of diabetes, of whom 909,813 had a LEDU. In propensity-matched Group 1 (12,676 episodes per cohort), AT patients had statistically fewer minor amputations (p=0.0367), major amputations (p<0.0001), ED visits (p<0.0001), and readmissions (p<0.0001) compared with NAT patients. In propensity-matched Group 2 (1131 episodes per cohort), AT FPFU patients had fewer minor amputations (p=0.002) than those in the AT not FPFU group. CONCLUSION: AT for the management of LEDUs was associated with significant reductions in major and minor amputation, ED use, and hospital readmission compared with LEDUs managed with NAT. Clinics should implement AT in accordance with the highlighted parameters for use to improve outcomes and reduce costs.

The value of the modern vascular surgeon to the health care system: A report from the Society for Vascular Surgery Valuation Work Group.

Vascular surgeons provide an important service to the health care system. They are capable of treating a wide range of disease processes that affect both the venous and arterial systems. Their presence broadens the complexity and diversity of services that a health care system can offer both in the outpatient setting and in the inpatient setting. Because of their ability to control hemorrhage, they are critical to a safe operating room environment. The vascular surgery service line has a positive impact on hospital margin through both the direct vascular profit and loss and the indirect result of assisting other surgical and medical services in providing care. The financial benefits of a vascular service line will hold true for a wide range of alternative payment models, such as bundled payments or capitation. To fully leverage a modern vascular surgeon's skill set, significant investment is required from the health care system that is, however, associated with substantial return on the investment.

Cryopreserved venous allograft is an acceptable conduit in patients with current or prior angioaccess graft infection.

OBJECTIVE: The durability of cryopreserved allograft has been previously demonstrated in the setting of infection. The objective of this study was to examine the safety, efficacy, patency, and cost per day of graft patency associated with using cryopreserved allograft (vein and artery) for hemodialysis access in patients with no autogenous tissue for native fistula creation and with arteriovenous graft infection or in patients at high risk for infection. METHODS: Patients implanted with cryopreserved allograft for hemodialysis access between January 2004 and January 2014 were reviewed using a standardized, multi-institutional database that evaluated demographic, comorbidity, procedural, and outcomes data. RESULTS: There were 457 patients who underwent placement of cryopreserved vein (femoral: n = 337, saphenous: n = 11) or artery (femoral: n = 109) for hemodialysis access at 20 hospitals. Primary indications for allograft use included high risk of infection in 191 patients (42%), history of infected prosthetic graft in 169 (37%), and current infection in 97 (21%). Grafts were placed more frequently in the arm (78%) than in the groin, with no difference in allograft conduit used. Mean time from placement to first hemodialysis use was 46 days (median, 34 days). Duration of functional graft use was 40 ± 7 months for cryopreserved vein and 21 ± 8 months for cryopreserved artery (P < .05), and mean number of procedures required to maintain patency at follow-up of 58 ± 21 months was 1.6 for artery and 0.9 for vein (P < .05). Local access complications occurred in 32% of patients and included late thrombosis (14%), graft stenosis (9%), late infection (9%), arteriovenous access malfunction (7%), early thrombosis (3%), and early infection (3%). Early and late infections both occurred more frequently in the groin (P = .030, P = .017, respectively), and late thrombosis occurred more frequently with cryopreserved artery (P < .001). Of the 82 patients (18%) in whom the cryopreserved allograft was placed in the same location as the excised infected prosthetic graft, 13 had infection of the allograft during the study period (early: n = 4; late: n = 9), with no significant difference in infection rate (P = .312) compared with the remainder of the study population. The 1-, 3-, and 5-year primary patency was 58%, 35%, and 17% for cryopreserved femoral vein and 49%, 17%, and 8% for artery, respectively (P < .001). Secondary patency at 1, 3, and 5 years was 90%, 78%, and 58% for cryopreserved femoral vein and 75%, 53%, and 42% for artery, respectively (P < .001). Mean allograft fee per day of graft patency was $4.78 for cryopreserved vein and $6.97 for artery (P < .05), excluding interventional costs to maintain patency. CONCLUSIONS: Cryopreserved allograft provides an excellent conduit for angioaccess when autogenous tissue is not available in patients with current or past conduit infection. Cryopreserved vein was associated with higher patency and a lower cost per day of graft patency. Cryopreserved allograft allows for immediate reconstruction through areas of infection, reduces the need for staged procedures, and allows early use for dialysis.

The Kaiser Permanente experience with ultrasound-guided percutaneous endovascular abdominal aortic aneurysm repair.

BACKGROUND: This study was conducted to determine the effect of ultrasound (US)-guided percutaneous access for percutaneous endovascular abdominal aortic aneurysm repair (PEVAR) on conversion to open repair by femoral cutdown. We also sought to identify other risk factors associated with failure of percutaneous access and conversion to femoral cutdowns. METHODS: This is a single-center, retrospective review of 101 patients who underwent PEVAR between January 1, 2005 and July 31, 2009 (56 months). Risk factors that were evaluated for unsuccessful PEVAR included gender, age (≤65 and ≥66 years), US-guided percutaneous access, mechanical failure, abdominal aortic aneurysm size, and the following comorbidities: diabetes, hypertension, vessel calcification, and obesity (body mass index: ≥30 kg/m(2)). RESULTS: There were 10 (9.9%) conversions from percutaneous to femoral cutdown, yielding a success rate of 90.1% for a total percutaneous approach. Each converted patient had one groin converted, resulting in a cutdown rate per groin of 10/202 (5%). There were no 30-day mortalities. Univariate analysis showed that hypertension (P = 0.261), age ≥66 years (P = 0.741), current smoking history (P = 0.649), past smoking history (P = .093), diabetes (P = 0.908), vessel calcification (P = 0.8281), and body mass index ≥30 kg/m(2) (P = 0.052) did not significantly predict conversion to endovascular aortic aneurysm repair (EVAR). Mechanical failure significantly predicted conversion to cutdown EVAR (P = 0.0002), whereas US-guided percutaneous access influenced successful PEVAR (P = 0.030). Multivariate analysis showed that mechanical failure significantly predicted conversion to cutdown EVAR (P = 0.003) and US-guided percutaneous access influenced successful PEVAR (P = 0.040) after adjusting for smoking history and obesity. CONCLUSION: PEVAR is a viable option for aortic aneurysm repair that may be improved with US-guided percutaneous access by reducing the rate of femoral cutdowns.

Simulator assessment of innate endovascular aptitude versus empirically correct performance.

OBJECTIVE: Prior work has established that performance on an endovascular simulator incorporating tactile feedback (haptics) correlates with previous endovascular experience and can be improved by training. This study was designed to test the ability to define and measure innate endovascular aptitude and empirically correct performance and to determine whether these are two different things. METHODS: Subjects ranging in endovascular skill level from novice to expert were surveyed to determine video game experience and skill, endovascular level of training, and endovascular experience. They were then tested by using a standard protocol requiring timed advancement of a catheter and wire sequentially into each of three vessels arising from a simulated type I arch. Recorded trials were independently and blindly scored by two experienced endovascular faculty members by using a modification of a previously validated scale (Modified Reznick Scale; MRS). Summed scores were analyzed by frequency analysis and categorized as satisfactory and unsatisfactory on the basis of a clear bimodal distribution. Categorical outcome, time to task completion, and other variables were analyzed by means of linear regression, analysis of variance, and Welch modified two-sample t tests, as indicated. RESULTS: A total of 61 subjects were enrolled: 42% students, 8% technicians, 19% surgeons, 13% cardiologists, and 18% radiologists. Of these, 62% were considered novices and 30% experts on the basis of previous experience; 56% of subjects worked in an endovascular-related occupation. MRS scores were highly correlated between raters (P < .0001) and showed a clear bimodal distribution, with subjects in any endovascular occupation (including technicians) scoring significantly better than all others (P < .0001). Hours of video games played per week were correlated highly with completion times (P < .001) and MRS scores (P < .001). Measures of formal training (number of endovascular cases and occupation) correlated highly with completion times (all P < .03) and MRS scores (all P < .008). In comparing completion times vs MRS scores, three groups were apparent: unskilled-inexperienced, skilled-inexperienced, and skilled-experienced, corresponding primarily to senior subjects without endovascular experience, younger subjects without endovascular experience, and formally trained endovascular physicians, respectively. Those judged intermediate in aptitude reduced times to the lowest possible level before improving their MRS scores. CONCLUSIONS: Although inherently subjective, the MRS yields reproducible scores that correlate with endovascular experience and formal training. Experts and novices with extensive video game experience achieve short completion times, whereas high MRS scores are achieved only by formally trained subjects. Innate endovascular aptitude and empirically correct performance may be two separate things, and aptitude may be acquirable through (or identified by) extensive nonmedical video game experience.