Intraoperative Pedal Pressure Changes Offers Another Quantitative Assessment for Revascularization.

BACKGROUND: Lower extremity angiography is one of the most prevalent vascular procedures performed, generally via the contralateral common femoral artery. The use of retrograde pedal artery access to perform angiography has long been reserved as a "bail-out" technique to help cross chronic total occlusions that were not amenable from an antegrade approach. Recently, there have been reports and discussions involving increased utilization of pedal access for primary revascularization. The purpose of this study is to describe the outcomes of pedal access as a primary approach and to propose a novel evaluation of distal perfusion changes associated with interventions using direct pressure measurements. METHODS: A retrospective observational study evaluating all patients who underwent lower extremity angiography via retrograde pedal access between December 1, 2020, and June 30, 2021, within a single health-care system spanning 3 hospitals was performed. Demographics, comorbidities, procedural indications, and details were all recorded. Hemodynamic measurements were obtained and recorded upon initial pedal access and post intervention with a pressure transducer connected directly to the access sheath. Outcomes were analyzed with paired t-test. RESULTS: Twenty-eight angiograms using primary pedal access for endovascular intervention were performed during the study period. Most patients were African American (75%) females (57.1%) with hypertension (89.3%), hyperlipidemia (78.6%), diabetes (85.7%), coronary artery disease (64.3%), and current tobacco users (57.1%). The most prevalent indication for angiography was nonhealing wounds (67.9%). Pedal access was mostly achieved via the anterior tibial artery (79%). Sixty-three vessels were treated during the 28 angiograms (averaging 2.3 vessels per angiogram), most commonly the superficial femoral (27%), anterior tibial (25%), and popliteal (22%) arteries. Balloon angioplasty with or without stenting (98.5%) was predominately performed with an overall technical success rate of 94%. The mean preintervention and postintervention pressures were 36.5 mm Hg (standard deviation [SD] 25.7) and 83.4 mm Hg (SD 19.5), respectively. The mean change in pressure after intervention was 46.9 mm Hg (SD 23.3) (Table 3). There was a statistically significant difference detected between preintervention and postintervention pressure (P < 0.001) (Figure 1). There were no major amputations or adverse cardiovascular events at a mean first follow-up duration of 89 days. Six of the total 28 patients (21.4%) underwent repeat endovascular intervention on the ipsilateral extremity within a median of 45 (interquartile range 22.5-62.3) days. CONCLUSIONS: Primary pedal access is a viable option for performing lower extremity angiographic interventions. A significant increase in pedal artery pressure can be observed after angiographic intervention from retrograde pedal artery access. Further studies are necessary to define the clinical prognostic importance of these findings in relation to wound healing rates.

A review of the incidence, outcome, and management of venous stent migration.

BACKGROUND: Percutaneous endovenous stenting has emerged during the past decade as the primary method of treating symptomatic venous outflow obstruction. A recognized complication of venous stenting is stent migration. The aim of the present systematic review was to identify the number of cases of stent migration in reported studies to recognize the risk factors that might be associated with this complication and the outcomes following migration. METHODS: A review was conducted in accordance with the MOOSE (meta-analyses of observational studies in epidemiology) and PRIMSA (preferred reporting items for systematic review and meta-analysis) guidelines and registered in the PROSPERO. MEDLINE, EMBASE, and PubMed databases. Key references were searched using specified keywords. All relevant data for the primary procedure and subsequent presentation with stent migration were retrieved. The data were assessed as too low in quality to allow for statistical analysis. RESULTS: Between 1994 and 2020, 31 studies were identified, including 29 case reports and 2 case series, providing data for 54 events of venous stent migration with some data provided regarding the stent used for 47 of the events. The mean age of the 52 patients with stent migration was 50 years (range, 19-88 years) and 30 were men (57.6%). The stents for most of the reported cases were ≤60 mm in length (38 of 46; 82.6%). Only three of the reports were of stents >14 mm in diameter (3 of 47; 3.6%). None of the studies had reported migration of stents >100 mm long. In 85% of the migrated stent events, retrieval was attempted, with 65.2% via an endovascular approach. The immediate outcome was satisfactory for 100% of the reported attempts, whether by an endovascular or open surgical approach. CONCLUSIONS: The findings from our literature review suggest that the risk of migration is rare but might be underreported. Most of reported cases had occurred with shorter and smaller diameter stents. The paucity of reported data and the short-term follow-up provided suggest that more formal data collection would provide a truer reflection of the incidence. However, clear strategies to avoid migration should be followed to prevent this complication from occurring.

Differences in Perioperative Outcomes after Carotid Revascularization between White and Non-white Patients.

BACKGROUND: Racial disparities in carotid endarterectomy (CEA) and carotid artery stenting (CAS) continue to persist. We aimed to provide a large-scale analysis of racial disparities in perioperative outcomes of carotid revascularization in a nationally representative cohort of patients, with sub-analyses stratifying by procedure type and symptomatic status. METHODS: We studied all patients undergoing carotid revascularization between 2011 and 2018 in the American College of Surgeons (ACS) National Surgical Quality Improvement Program (NSQIP) Database. Univariate methods were used to compare patients' demographic and medical characteristics. Multivariable logistic regression analysis was used to compare adjusted perioperative outcomes between white patients (WP) and non-white patients (NWP). Sub-analysis was performed stratifying by method of revascularization and symptomatic status. RESULTS: A total of 31,356 carotid revascularizations were performed in 26,550 (84.7%) white patients and 4,806 (15.3%) non-white patients. On adjusted analysis, NWP had increased odds of stroke (OR:1.2, 95%CI:1.1-1.5, P = 0.0496), unplanned return to the OR (OR:1.4, 95%CI:1.1-1.6, P < 0.001) and restenosis (OR:2.6, 95%CI:1.7-3.9, P < 0.001). On sub-analysis, NWP undergoing CAS had increased odds of stroke/death (OR:2.2, 95%CI:1.1-4.3, P = 0.025), stroke (OR:2.9, 95%CI:1.3-6.0, P = 0.007), and stroke/TIA (OR:2.1, 95%CI:1.0-4.2, P = 0.025). NWP undergoing CEA had increased odds of unplanned return to the OR (OR:1.4, 95%CI:1.2-1.6, P < 0.001) and restenosis (OR:2.7, 95%CI:1.7-4.0, P < 0.001). CONCLUSION: NWP had higher rates of 30-day stroke, driven primarily by higher rates of perioperative stroke/death in NWP undergoing CAS. NWP undergoing CEA did not have higher rates of stroke/death after adjusted analysis, although they had higher rates of unplanned return to OR and restenosis. Upon stratification for symptomatic status, the stroke/death rate between NWP and WP was shown to be non-significant.

Female Gender is a Predictor of Lower Iliac Vein Stenting Patency Rates.

BACKGROUND: Iliac venous stenting (IVS) for thrombotic and nonthrombotic venous disease is increasingly used as evidence of the safety, efficacy and durability of these interventions increases. Female gender has been implicated as a predictor of failure in arterial endovascular interventions. We hypothesize that female gender could be predictive of patency rates of iliac vein stenting. METHODS: Consecutive patients who underwent IVS for thrombotic or nonthrombotic venous disease at our institution from 2007 until 2019 were identified and divided into groups based on gender. Operative notes, venograms, and the electronic health record were then queried to obtain operative details, co-morbid conditions, postoperative outcomes and stent patency. Study outcome was long term patency rate. The data was analyzed using chi-square, logistic regression, and Kaplan-Meier analysis as appropriate. RESULTS: A total of 200 consecutive patients (231 limbs) were identified in our retrospective analysis, with a mean age of 48.8 ± 17.3, and BMI of 31.6 ± 8.6. Of those, 119 (59.5%) patients, (131 [56.8%] limbs) were female. Comparisons between the gender groups revealed no difference in age, BMI, or preoperative comorbidities. There was no difference in type of venous disease between male (85% thrombotic, 15% nonthrombotic) and female (84% thrombotic, 16% nonthrombotic), P= 0.830. The male cohort was more likely to present with leg ulceration (17% vs. 4.6%, P = 0.002), and the female cohort was more likely to present with leg edema (98.5% vs. 93.0%, P= 0.03). The male cohort had a higher rate of caval (48% vs. 33.6%, P= 0.027) and infrainguinal stent extension. (11% vs. 6.9%, P= 0.02). Females had a higher rate of left sided stenting (80.9% vs. 66/0%, P= 0.010). There was no difference in the median stent diameter used between the cohorts. Primary patency at 5 years was significantly higher for the male cohort (94.1% vs. 74.4%, P= 0.01) On adjusted multivariable cox regression female gender was a predictor of loss of primary patency within 5 years (HR, 4.04; P= 0.007). CONCLUSIONS: In this single center retrospective analysis of IVS, male patients were found to have better primary stent patency compared to female.

How Does Female Sex Affect Complex Endovascular Aortic Repair? A Single Centre Cohort Study.

OBJECTIVE: There is growing evidence of a female patient disadvantage in complex endovascular aortic repair using fenestrated and branched endografts (FB-EVAR) primarily related to peri-procedural events including ischaemic and access vessel complications. This study aimed to determine the impact of sex differences on treatment patterns, and in hospital outcomes in a single centre cohort. METHODS: This was a retrospective cross sectional single centre cohort study of all consecutive FB-EVAR procedures provided to patients with asymptomatic pararenal and thoraco-abdominal aortic aneurysm (TAAA) between 1 January 2010 and 28 February 2021. Adjusted multivariable logistic regression models were developed using backward (Wald) elimination of variables to determine the independent impact of female sex on short term outcomes. RESULTS: In total, 445 patients (24.3% females, median age 73.0 years, IQR 66, 78) were included. Female patients had a smaller aneurysm diameter, less frequent coronary artery disease (29.6% vs. 44.8%, p = .007) and history of myocardial infarction (2.8% vs. 15.4%, p < .001) when compared with males. Females were more frequently treated for TAAA than males (49.1% vs. 25.2%, p < .001). The median length of post-procedural hospital stay was 10 days in females and 9 in males. In adjusted analyses, female sex was independently associated with higher mortality (odds ratio [OR] 10.135, 95% CI 2.264 - 45.369), post-procedural complications (OR 2.500, 95% CI 1.329 - 4.702), spinal cord ischaemia (OR 4.488, 95% CI 1.610 - 12.509), sepsis (OR 4.940, 95% CI 1.379 - 17.702), and acute respiratory insufficiency (OR 3.283, 95% CI 1.015 - 10.622) after pararenal aortic aneurysm repair during the hospital stay. CONCLUSION: In this analysis of consecutively treated patients, female sex was associated with increased in hospital mortality, peri-procedural complications, and spinal cord ischaemia after elective complex endovascular repair of pararenal aortic aneurysm, while no differences were revealed in the TAAA subgroup. These results suggest that sex related patient selection and peri-procedural management should be studied in future research.

Editor's Choice - Cost Effectiveness of Primary Stenting in the Superficial Femoral Artery for Intermittent Claudication: Two Year Results of a Randomised Multicentre Trial.

OBJECTIVE: Invasive treatment of intermittent claudication (IC) is commonly performed, despite limited evidence of its cost effectiveness. IC symptoms are mainly caused by atherosclerotic lesions in the superficial femoral artery (SFA), and endovascular treatment is performed frequently. The aim of this study was to investigate its cost effectiveness vs. non-invasive treatment. METHODS: One hundred patients with IC due to lesions in the SFA were randomised to treatment with primary stenting, best medical treatment (BMT) and exercise advice (stent group), or to BMT and exercise advice alone (control group). Patients were recruited at seven hospitals in Sweden. For this analysis of cost effectiveness after 24 months, 84 patients with data on quality adjusted life years (QALY; based on the EuroQol Five Dimensions EQ-5D 3L™ questionnaire) were analysed. Patient registry and imputed cost data were used for accumulated costs regarding hospitalisation and outpatient visits. RESULTS: The mean cost per patient was €11 060 in the stent group and €4 787 in the control group, resulting in a difference of €6 273 per patient between the groups. The difference in mean QALYs between the groups was 0.26, in favour of the stent group, which resulted in an incremental cost effectiveness ratio (ICER) of € 23 785 per QALY. CONCLUSION: The costs associated with primary stenting in the SFA for the treatment of IC were higher than for exercise advice and BMT alone. With concurrent improvement in health related quality of life, primary stenting was a cost effective treatment option according to the Swedish national guidelines (ICER < €50 000 - €70 000) and approaching the UK's National Institute for Health and Care Excellence threshold for willingness to pay (ICER < £20 000 - £30 000). From a cost effectiveness standpoint, primary stenting of the SFA can, in many countries, be used as an adjunct to exercise training advice, but it must be considered that successful implementation of structured exercise programmes and longer follow up may alter these findings.

Could Gender Impact on Immediate and Long-term Carotid Artery Stenting Outcome? Insight from an Italian Single Center Experience.

BACKGROUND: Carotid artery stenting (CAS) has become a valid alternative to carotid endarterectomy in stroke prevention. However, female gender is still considered as an independent risk factor for CAS procedures, potentially limiting immediate and long-term benefits. Aim of present study was to evaluate gender differences in CAS submitted patients from an Italian high-volume center. MATERIAL AND METHODS: a retrospective monocentric study has been conducted on 568 patients (366 males and 202 females), submitted to CAS, between January 2000 and December 2019. Besides gender sex, clinical anatomical, and procedural data were collected as possible factors determining the outcome, when associated to sex gender itself. Primary endpoint of this study consisted in evaluating the technical and procedural success ratio, and the incidence of major and minor stroke, transient ischemic attack, acute myocardial infarction (AMI) peri-procedurally and at medium and long term, between the male and the female population. Secondary endpoint of this study consisted in evaluating the percentage ratio of minor complications happening peri-procedurally in both genders. RESULTS: Male patients were more likely to be octogenarians, clinical history of coronary artery disease, and smokers, while diabetes was more frequent in female patients. Anatomical and plaque morphology features were not different between the two groups. Technical success was obtained in all but two patients (99,6%), while procedural success was 95% (538/566 patients). During the peri-procedural time, no major stroke, 16 minor strokes (2,81%, 2,45% males vs. 3,45% females, P= 0,48), and 11 transient ischemic attack (2,18% males vs. 1,48% females, P= 0,56) were recorded. At a medium follow-up 57 months, 32 stroke (8 major strokes, 24 minor strokes) episodes (5,6%, males 5,7% vs. females 5,4%, P= 0,88), 24 AMIs (4,2%, males 4,6% vs. females 3,46%, P= 0,5;), 13 restenosis (2,8%, males 2,4% vs. females 1,9%, P= 0,71) and 223 deaths (39,2%, males 34,9% vs. females 47%, P= 0,0048) were noted. CONCLUSIONS: Our results showed no differences in immediate, and long-term CAS outcomes between gender. Larger, prospective studies are required to assess the real importance and significance of gender in determining CAS procedures' benefit and outcome.

Longitudinal Assessment of Safety of Femoropopliteal Endovascular Treatment With Paclitaxel-Coated Devices Among Medicare Beneficiaries: The SAFE-PAD Study.

Importance: Paclitaxel-coated peripheral devices have been associated with increased mortality, yet this harm signal has not been replicated outside of meta-analyses of small trials. Objective: To provide a longitudinal assessment of the safety of femoropopliteal endovascular treatment with peripheral drug-coated devices (DCDs) among Medicare beneficiaries. Design, Setting, and Participants: SAFE-PAD (Safety Assessment of Femoropopliteal Endovascular Treatment With Paclitaxel-Coated Devices) was a retrospective cohort study designed with the US Food and Drug Administration to evaluate the noninferiority of mortality between DCDs and non-drug-coated devices (NDCDs) for femoropopliteal revascularization performed in 2978 inpatient and outpatient facilities in the US from April 1, 2015, through December 31, 2018. Evaluation of the primary outcome was assessed through May 31, 2020. Participants were Medicare fee-for-service beneficiaries 66 years and older with 1 or more years of enrollment prior to femoropopliteal revascularization. Prespecified subgroups included low-risk cohorts, procedure location, disease severity, and device type. Inverse probability weighting was used to account for imbalances of observed characteristics. Sensitivity analyses were used to evaluate the potential influence of unmeasured confounding. Exposures: Treatment with DCDs vs NDCDs as determined by claims codes during the index procedure. Main Outcomes and Measures: The primary outcome was all-cause mortality. Secondary outcomes included repeated hospitalization, repeated lower extremity revascularization, and lower extremity amputation. Falsification end points were acute myocardial infarction, congestive heart failure, and pneumonia. Results: Of 168 553 patients, 70 584 (41.9%) were treated with a DCD. The mean (SD) age was 77.0 (7.6) years, 75 744 (44.9%) were female, 136 916 of 167 197 (81.9%) were White individuals, 85 880 of 168 553 (51.0%) had diabetes, 82 554 of 168 553 (49.0%) used tobacco, 78 665 of 168 553 (45.7%) had critical limb ischemia (CLI), and 13 296 of 168 553 (7.9%) had a prior amputation. Median follow-up was 2.72 years (interquartile range, 0.87-3.77; longest, 5.16 years). After weighting, the cumulative incidence of all-cause mortality was 53.8% with DCDs and 55.1% with NDCDs (hazard ratio [HR], 0.95; 95% CI, 0.94-0.97; noninferiority P < .001). Cox regression and instrumental variable analyses were consistent with the primary findings. No harm associated with DCDs was observed among subgroups, including those treated with stents (HR, 0.97; 95% CI, 0.95-1.00) or balloons (HR, 0.94; 95% CI, 0.92-0.96), with or without CLI (CLI: HR, 0.95; 95% CI, 0.93-0.97; non-CLI: HR, 0.97; 95% CI, 0.95-0.99), and those within the lowest quartile of total comorbidities (HR, 0.95; 95% CI, 0.92-0.99). Conclusions and Relevance: In this initial report from the SAFE-PAD cohort study, DCDs were found to be noninferior to NCDCs in respect to mortality through a median follow-up of 2.72 years. This finding remained robust in sensitivity analyses and was consistent across prespecified subgroups.

Hospitalization Cost and In-hospital Outcomes Following Type B Thoracic Aortic Dissection Repair.

BACKGROUND: Several studies have reported lower mortality and morbidity after thoracic endovascular aortic repair (TEVAR) when compared to open surgical repair (OSR) in the treatment of type B aortic dissection (TbAD). However, there are few studies in the literature on the cost of both treatment options. Thus, the aim of this study is to focus on in-hospital outcomes and cost associated with TbAD repair procedures in a national database in the United States. METHODS: A retrospective review of the Premier Healthcare Database (PHD) between June 2009 and March 2015 was performed. ICD-9-CM codes were used to identify patients who underwent OSR or TEVAR for TbAD. Endpoints included in-hospital adverse events, in-hospital mortality and hospitalization cost. Logistic regression models and generalized linear models were used to assess the impact of treatment type on the main outcomes. RESULTS: Out of 1752 patients with TbAD, 54.3% underwent OSR and 45.7% underwent TEVAR. Patients in the TEVAR group were older [median age, 64 (IQR 54-73) vs. 59 (IQR 49-70), P < 1] and more likely to have preexisting comorbidities. IAE rates were 78.6% for the OSR group compared to 43.1% for the TEVAR group, P < 0.001. Patients in the OSR group showed significantly higher in-hospital mortality (15.3% vs. 5.9%, P < 0.001). After adjusting for potential confounders, OSR was associated with a 5-fold increase in IAE [aOR(95%CI): 4.8 (3.8-6.1), P < 0.001] and a 3-fold increase in in-hospital mortality [aOR(95%CI): 3.3 (2.1-5.1), P < 0.001]. In regards to charges related to the hospital stay, total cost was significantly higher among patients undergoing OSR $53,371 ($39,029-$80,471) vs. TEVAR $45,311 ($31,479-$67,960), P < 0.001. CONCLUSION: The present study shows that TEVAR presents an advantage in terms of morbidity, mortality and cost when compared to OSR in the treatment of TbAD. However, long-term cost-effectiveness of both procedures remains unknown. Further research is warranted to see whether the superiority of TEVAR is maintained over time.

Sex-related outcomes after fenestrated-branched endovascular aneurysm repair for thoracoabdominal aortic aneurysms in the U.S. Fenestrated and Branched Aortic Research Consortium.

OBJECTIVE: Fenestrated-branched endovascular aneurysm repair (FBEVAR) has expanded the treatment of patients with thoracoabdominal aortic aneurysms (TAAAs). Previous studies have demonstrated that women are less likely to be treated with standard infrarenal endovascular aneurysm repair because of anatomic ineligibility and experience greater mortality after both infrarenal and thoracic aortic aneurysm repair. The purpose of the present study was to describe the sex-related outcomes after FBEVAR for treatment of TAAAs. METHODS: The data from 886 patients with extent I to IV TAAAs (excluding pararenal or juxtarenal aneurysms), enrolled in eight prospective, physician-sponsored, investigational device exemption studies from 2013 to 2019, were analyzed. All data were collected prospectively, audited and adjudicated by clinical events committees and/or data safety monitoring boards, and subject to Food and Drug Administration oversight. All the patients had been treated with Cook-manufactured patient-specific FBEVAR devices or the Cook t-Branch off-the-shelf device (Cook Medical, Brisbane, Australia). RESULTS: Of the 886 patients who underwent FBEVAR, 288 (33%) were women. The women had more extensive aneurysms and a greater prevalence of diabetes (33% vs 26%; P = .043) but a lower prevalence of coronary artery disease (33% vs 52%; P < .0001) and previous infrarenal endovascular aneurysm repair (7.6% vs 16%; P < .001). The women had required a longer operative time from incision to surgery end (5.0 ± 1.8 hours vs 4.6 ± 1.7 hours; P < .001), experienced lower technical success (93% vs 98%; P = .002), and were less likely to be discharged to home (72% vs 83%; P = .009). Despite the smaller access vessels, the women did not have an increased incidence of access site complications. Also, the 30-day outcomes were broadly similar between the sexes. At 1 year, no differences were found between the women and men in freedom from type I or III endoleak (91.4% vs 92.0%; P = .64), freedom from reintervention (81.7% vs 85.3%; P = .10), target vessel instability (87.5% vs 89.2%; P = .31), and survival (89.6% vs 91.7%; P = .26). The women had a greater incidence of postoperative sac expansion (12% vs 6.5%; P = .006). Multivariable modeling adjusted for age, aneurysm extent, aneurysm size, urgent procedure, and renal function showed that patient sex was not an independent predictor of survival (hazard ratio, 0.83; 95% confidence interval, 0.50-1.37; P = .46). CONCLUSIONS: Women undergoing FBEVAR demonstrated metrics of increased complexity and had a lower level of technical success, especially those with extensive aneurysms. Compared with the men, the women had similar 30-day mortality and 1-year outcomes, with the exception of an increased incidence of sac expansion. These data have demonstrated that FBEVAR is safe and effective for women and men but that further efforts to improve outcome parity are indicated.

A health insurance claims analysis on the effect of female sex on long-term outcomes after peripheral endovascular interventions for symptomatic peripheral arterial occlusive disease.

OBJECTIVE: Several reports have addressed sex disparities in peripheral arterial occlusive disease (PAOD) treatment with inconclusive or even conflicting results. However, most previous studies have neither been sufficiently stratified nor used matching or weighting methods to address severe confounding. In the present study, we aimed to determine the disparities between sexes after percutaneous endovascular revascularization (ER) for symptomatic PAOD. METHODS: Health insurance claims data from the second-largest insurance fund in Germany, BARMER, were used. A large cohort of patients who had undergone index percutaneous ER of symptomatic PAOD from January 1, 2010 to December 31, 2018 were included in the present study. The study cohort was stratified by the presence of intermittent claudication, ischemic rest pain, and wound healing disorders. Propensity score matching was used to adjust for confounding through differences in age, treated vessel region, comorbidities, and pharmacologic treatment. Sex-related differences regarding cardiovascular event-free survival, amputation-free survival, and overall survival within 5 years of surgery were determined using Kaplan-Meier time-to-event curves, log-rank test, and Cox regression analysis. RESULTS: In the present study, 50,051 patients (47.2% women) were identified and used to compose a matched cohort of 35,232 patients. Among all strata, female patients exhibited lower mortality (hazard ratio [HR], 0.69-0.90), fewer amputations or death (HR, 0.70-0.89), and fewer cardiovascular events or death (HR, 0.78-0.91). The association between female sex and improved long-term outcomes was most pronounced for the patients with intermittent claudication. CONCLUSIONS: In the present propensity score-matched analysis of health insurance claims, we observed superior cardiovascular event-free survival, amputation-free survival, and overall survival during 5 years of follow-up after percutaneous ER in women with symptomatic PAOD. Future studies should address sex disparities in the open surgical treatment of PAOD to illuminate whether the conflicting data from previous reports might have resulted from insufficient stratification of the studies.

Ten-Year Clinical Characteristics and Early Outcomes of Type B Aortic Dissection Patients With Thoracic Endovascular Aortic Repair.

OBJECTIVE/BACKGROUND: This study examined the 10-year hospitalization characteristics, economic patterns and early clinical outcomes of type B aortic dissection (TBAD) patients that underwent thoracic endovascular aortic repair (TEVAR) in one high-volume hospital in China. METHODS: We performed a population-based retrospective analysis based on electronic medical record system data provided by Zhongshan Hospital Fudan University from 2009 to 2018. RESULTS: We identified 1,367 cases of TBAD patients with TEVAR over the past decade. The total incidence of in-hospital complications was 7.6% (104 of 1,367), among which acute kidney injury (AKI) had the highest incidence (3.1%, 42 of 1,367). Aortic-related reintervention was performed in 7 patients (0.5%). The overall aortic-related in-hospital mortality rate was 2.7% (37 of 1,367) and had no significant time-varying trend (P = 0.2). Among these, 27% of in-hospital deaths were caused by retrograde type A dissection (RTAD). Chronic TBAD had a higher risk of in-hospital death versus acute TBAD, with a risk ratio of 2.69 (95% confidence interval [CI]: 1.19-6.09). Patients with hypertension (risk ratio 4.63, 95% CI: 1.38, 15.54) also had a higher in-hospital death risk. These 2 factors were also the predictive factors for the composite endpoint of in-hospital adverse events (risk ratio 2.17, 95% CI: 1.43, 3.29 and risk ratio 4.83, 95% CI: 1.90, 12.28, respectively), in addition to Marfan syndrome (risk ratio 4.05, 95% CI: 1.61, 10.19). The average length of hospitalization significantly declined during the past decade (annual percentage change -6.3%, 95% CI -8.2 to -4.3), and the stent-grafts (SGs) cost was the main expenditure of the total hospitalization costs. CONCLUSION: Our study showed a favorable early outcome of TEVAR over the past decade. Greater attention should be paid to certain risk factors in order to reduce the in-hospital adverse events. SG expenditure is still the primary economic burden on Chinese TBAD patients.

Contemporary nationwide trends and in-hospital outcomes of adjunctive stenting in patients undergoing catheter-directed thrombolysis for proximal deep venous thrombosis.

OBJECTIVE: Outflow venous stenting as an adjunct to catheter-directed thrombolysis (CDT) is performed to prevent recurrent thrombosis and to reduce the risk of post-thrombotic syndrome. Historical data show that stenting improves outcomes of surgical thrombectomy in patients with iliofemoral deep venous thrombosis (DVT), and recent observational data suggest that stenting improves long-term outcomes of CDT. However, the impact of stenting during CDT on acute safety outcomes is unknown. We sought to investigate the contemporary trends, safety outcomes, and resource utilization of adjunctive stent placement in patients undergoing CDT. METHODS: Patients with proximal lower extremity and caval DVT were identified within the National Inpatient Sample from January 2005 to December 2013. From this data set, we stratified our patients into three groups: patients who received CDT alone, patients who received CDT plus angioplasty, and patients who received CDT plus angioplasty with stenting. We used an inverse probability treatment weighting algorithm to create three weighted cohorts. Cochran-Armitage test was used to evaluate the trends of stent placement among patients treated with CDT. The primary outcome was a composite end point of all-cause mortality, gastrointestinal bleed, or intracranial hemorrhage. RESULTS: A total of 138,049 patients were discharged with a principal diagnosis of proximal and caval DVT; 7097 of these patients received CDT (5.1%). From this group, 2854 (40.2%) were treated with CDT alone, 2311 (32.6%) received adjunctive angioplasty alone, and 1932 (27.2%) received adjunctive angioplasty and stent. Adjunctive stenting had a significantly lower rate of primary composite outcome compared with CDT alone (2.7% vs 3.8%; P = .04). Stent placement was associated with a similar length of stay compared with angioplasty and CDT alone groups (6.8 vs 6.9 vs 7.1 days, respectively; P = .94) and higher in-hospital charges ($115,164.01 ± $76,985.31 vs $98,089.82 ± $72,921.94 vs $80,441.63 ± $74,024.98; P < .001). CONCLUSIONS: This nationwide study suggests that one in four patients undergoing CDT is treated with adjunctive stent placement in the United States. This observational study showed that adjunctive stenting does not adversely affect the acute safety outcomes of CDT; however, it was associated with increased hospital charges.

A contemporary assessment of devices for Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA): resource-specific options per level of care.

PURPOSE: Use of Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) as adjunct for temporary hemorrhage control in patients with exsanguinating torso hemorrhage is increasing. Characteristics of aortic occlusion balloons (AOB) are diverse and evolving as efforts are made to improve the technology. It is important to select a device that fits the requirements of the medical situation to minimize the risk of failure and complications. The aim of this study is to appraise guidance in the choice of an AOB in a specific situation. METHODS: We assessed 29 AOB for differences and outline possible advantages and disadvantages of each. Bending stiffness was measured with a three-point bending device. RESULTS: Diameter of the AOB ranged from 6 (ER-REBOA™) to 10 (Coda®-46) French. However, some need large-bore access sheaths up to 22 French (Fogarty®-45 and LeMaitre®-45) or even insertion via cut-down (Equalizer™-40). Bending stiffness varied from 0.08 N/mm (± 0.008 SD; Coda®-32) to 0.72 N/mm (± 0.024 SD; Russian prototype). Rescue Balloon™ showed kinking of the shaft at low bending pressures. The only non-compliant AOB is REBOA Balloon®. ER-REBOA™, Fogarty®, LeMaitre®, REBOA Balloon®, and Rescue Balloon™ are provided with external length marks to assist blind positioning. CONCLUSION: In resource-limited settings, a guidewire- and fluoroscopy-free, rather stiff device, such as ER-REBOA™, Fogarty®, and LeMaitre®, is warranted. Of these devices, ER-REBOA™ is the only catheter compatible with seven French sheaths and specifically designed for emergency hemorrhage control. Of the over-the-wire devices, Q50® has several features that facilitate use and reduce the risk of malplacement or vessel damage.

Financial viability of endovascular aortic repair in the modern era.

BACKGROUND: In the current era of cost containment, the financial impact of high-cost procedures such as endovascular aneurysm repair (EVAR) remains an area of intensive interest. Previous reports suggested slim to negative operating margins with EVAR, prompting widespread initiatives to reduce cost and to improve reimbursement. In 2015, the Centers for Medicare and Medicaid Services (CMS) announced the reclassification of EVAR to more specific diagnosis-related group (DRG) coding and predicted an overall increase in hospital reimbursement. The potential impact of this change has not been described. METHODS: Patients undergoing elective EVAR at a single institution between January 2014 and December 2018 were identified retrospectively, then stratified by date. Group 1 patients underwent EVAR before DRG change in 2015 and were classified with DRG 237/238, major cardiovascular procedure. Group 2 patients underwent EVAR after the change and were classified as DRG 268/269, aortic/heart assist procedures. The total direct cost included implant cost, operating room (OR) labor, room and board, and other supply costs. Net revenue reflected real payer mix values without extrapolation based on standard Medicare rates. Hospital profit was defined as the contribution to indirect (CTI), subtracting total direct cost from net revenue. RESULTS: A total of 188 encounters were included, 67 (36%) in group 1 and 121 (64%) in group 2. Medicare patients composed 84% of group 1 and 81% of group 2. CTI (profit) increased by $4447 (+123%) from $3615 in group 1 to $8062 in group 2. Net revenue per encounter increased by $2054 (+7.1%). In group 1, the higher reimbursement DRG code 237 was applied in 5 of 67 (7.5%) patients, whereas DRG code 268 was assigned in 19 of 121 (15.1%) patients in group 2. Total direct cost per encounter decreased by $2012 (-7.9%). This decrease in cost was driven by a reduction in implant cost, from a mean $16,914 per encounter in group 1 to a mean $15,655 in group 2 (-$1259 or -7.4% per encounter) and by a decrease in OR labor cost, $2838 in group 1 to $2361 in group 2 (-$477 or -17.0% per encounter). CONCLUSIONS: A significant improvement in hospital CTI was observed for elective EVAR during the course of the study. The increased DRG reimbursement after the Centers for Medicare and Medicaid Services coding changes in 2015 was a major driver of this salutary change. Notably, efforts to reduce implant and OR cost as well as to improve coding and documentation accuracy over time had an equally important impact on financial return.

Contemporary Trends in Physician Utilization Rates of CEA and CAS for Asymptomatic Carotid Stenosis among Medicare Beneficiaries.

BACKGROUND: Carotid revascularization for asymptomatic carotid artery stenosis (ACAS) has become increasingly controversial in the past few decades as the best medical therapy has improved. The aim of this study was to assess and define contemporary trends in the rate of carotid revascularization procedures for ACAS in the United States and to characterize outlier physicians performing a higher rate of asymptomatic revascularization compared to their peers. METHODS: We used 100% Medicare fee-for-service claims to identify all patients who were newly diagnosed with ACAS between 01/2011-06/2018. Patients with symptomatic carotid artery stenosis, those with prior carotid revascularization, and surgeons who performed ≤10 CEAs during the study period were excluded. We used a hierarchical multivariable logistic regression model to evaluate patient and physician characteristics associated with undergoing a carotid endarterectomy or carotid artery stent procedure within 3 months after the initial diagnosis of ACAS. We also assessed temporal trends in carotid revascularization rates over time using the Cochran-Armitage Trend Test. RESULTS: Overall, 795,512 patients (median age 73.9 years, 50.9% male, 87.6% white) had a first-time diagnosis of ACAS during the study period, of which 23,481 (3.0%) underwent carotid revascularization within 3 months. There was a significant decline in overall carotid artery revascularization rates over time (2011: 3.2% vs. 2018: 2.1%; P < 0.001). The median and mean physician-specific carotid revascularization rates were 2.0% (IQR 0.0%-6.3%) and 4.7% ± 7.1%, respectively. Three-hundred and fifty physicians (5.2%) had carotid revascularization rates ≥19%, which was more than 2 standard deviations above the mean. After adjusting for patient-level characteristics, physician-level variables associated with carotid revascularization for newly diagnosed ACAS included male sex (adjusted OR 1.59, 95% CI 1.35-1.89), more years in practice (≥31 vs. <10 years, aOR 1.64, 95% CI 1.32-2.04), rural practice location (aOR 1.34, 95% CI 1.18-1.52), Southern region practice location (versus Northeast, aOR 1.54, 95% CI 1.39-1.69), and lower volume of ACAS patients (lower versus upper tertile, aOR 2.62, 95% CI 2.39-2.89). Cardiothoracic surgeons had a 1.52-fold higher odds of carotid revascularization compared to vascular surgeons (95% CI 1.36-1.68), whereas cardiologists and radiologists had lower intervention rates (both, P < 0.05). CONCLUSIONS: The current early revascularization rate for newly diagnosed ACAS is <5% among proceduralists in the United States, and has been decreasing steadily since 2014. There are particular physician-level characteristics that are associated with higher rates of carotid revascularization that cannot be fully contextualized without high-level contemporary outcomes data to guide decision making in ACAS.

Hospital-Level Medicaid Prevalence Is Associated with Increased Length of Stay after Asymptomatic Carotid Endarterectomy and Stenting Despite no Increase in Major Complications.

BACKGROUND: Length of stay (LOS) after carotid endarterectomy (CEA) and carotid artery stenting (CAS) for asymptomatic disease is used as a quality measure and affects hospital operating margins. Patient-level Medicaid status has traditionally been associated with longer hospital LOS. Our goal was to assess the association between hospital-level Medicaid prevalence and postoperative LOS after CEA and CAS. METHODS: The National Inpatient Sample was queried from 2006-2014 for CEA and CAS performed for asymptomatic carotid stenosis. Overall hospital-level Medicaid prevalence was divided into quartiles. The quartiles were further categorized into low Medicaid prevalence (LM) (lowest quartile), medium Medicaid prevalence (MM) (second and third quartiles), and high Medicaid prevalence (HM) (fourth quartile) cohorts. The primary outcome evaluated was postoperative LOS >1 day. The secondary outcomes included perioperative/in-hospital complications and mortality. RESULTS: There were 984,283 patients with asymptomatic carotid stenosis who underwent CEA (88%) or CAS (12%). Mean postoperative LOS after CEA at hospitals with LM, MM, and HM prevalence was 1.4 ± 1.5, 2.1 ± 2.5, and 2.2 ± 2.8 days (P = 0.0001), respectively, and after CAS were 1.7 ± 2.6, 1.8 ± 2.1, and 2 ± 2.6 days (P < 0.0001), respectively. After CEA, relative to LM prevalence, MM (OR 1.62, 95% CI 1.17-2.24) and HM (OR 1.66, 95% CI 1.2-2.28) prevalence were associated with a higher likelihood of LOS > 1 day (P = 0.009). After CAS, relative to LM prevalence, HM prevalence was associated with a higher likelihood of LOS >1 day (OR 1.42, 95% CI 1.06-1.91) (P = 0.003). After CEA, neurologic (0.8% vs. 0.9% vs. 0.9%, P = 0.83) and cardiac complications (0.9% vs. 1.2% vs. 1.2%, P = 0.24) were similar among hospitals with LM, MM, and HM prevalence, respectively. After CAS, the prevalence of neurological (1.1% vs. 1% vs. 1.2%, P = 0.42) and cardiac complications (2% vs. 1.3% vs. 1.5%, P = 0.46) were also similar. After both CEA and CAS, mortality was similar among Medicaid prevalence cohorts. CONCLUSIONS: Higher hospital-level Medicaid prevalence was associated with longer LOS after CEA and CAS for asymptomatic carotid stenosis. Value-based payment models should adjust for hospital-level Medicaid prevalence to appropriately reimburse providers and hospital with higher Medicaid prevalence as well as investigate care pathways and systems improvement to help reduce LOS.

Improving Quality of Carotid Interventions: Identifying Hospital-Level Structural Factors that can Improve Outcomes.

BACKGROUND: "Structural factors" relating to organization of hospitals may affect procedural outcomes. This study's aim was to clarify associations between structural factors and outcomes after carotid endarterectomy (CEA) and carotid endarterectomy stenting (CAS). METHODS: A systematic review of studies published in English since 2005 was conducted. Structural factors assessed were as follows: population size served by the vascular department; number of hospital beds; availability of dedicated vascular beds; established clinical pathways; surgical intensive care unit (SICU) size; and specialty of surgeon/interventionalist. Primary outcomes were as follows: mortality; stroke; cardiac complications; length of hospital stay (LOS); and cost. RESULTS: There were 11 studies (n = 95,100 patients) included in this systematic review. For CEA, reduced mortality (P < 0.0001) and stroke rates (P = 0.001) were associated with vascular departments serving >75,000 people. Larger hospitals were associated with lower mortality, stroke rate, and cardiac events, compared with smaller hospitals (less than 130 beds). Provision of vascular beds after CEA was associated with lower mortality (P = 0.0008) and fewer cardiac events (P = 0.03). Adherence to established clinical pathways was associated with reduced stroke and cardiac event rates while reducing CEA costs. Large SICUs (≥7 beds) and dedicated intensivists were associated with decreased mortality after CEA while a large SICU was associated with reduced stroke rate (P = 0.001). Vascular surgeons performing CEA were associated with lower stroke rates and shorter LOS (P = 0.0001) than other specialists. CAS outcomes were not influenced by specialty but costless when performed by vascular surgeons (P < 0.0001). CONCLUSIONS: Structural factors affect CEA outcomes, but data on CAS were limited. These findings may inform reconfiguration of vascular services, reducing risks and costs associated with carotid interventions.

Poor concordance between definitions of type III arch and implications for risk prediction and assessment for carotid artery stenting.

OBJECTIVE: The type III arch configuration has been inconsistently reported as a stroke risk factor during carotid artery stenting. However, at least three different methods for the definition of type III arch can be identified in the literature, related to the level of the origin of the innominate artery (IA). According to Casserly's definition, a type III arch presents with an origin of the IA below the horizontal plane of the inner curvature. According to Madhwal's definition, a type III arch has a distance greater than twice the diameter of the left common carotid artery between the highest point of the arch and the origin of the IA. According to MacDonald's definition, a type III arch presents with a distance of ≥2 cm between the highest point of the arch and the origin of the IA. Our aim was to assess the level of concordance between these different methods. METHODS: Anonymized thoracic computed tomography scans of 100 healthy patients were reviewed. Two of us independently stratified the selected cases as a type I to III arch, according to the three considered definitions. The interobserver level of concordance for each type III arch classification and level of concordance among the three definitions were assessed. RESULTS: The 100 selected patients (64% male) were 76 ± 7 years old. For each definition, the interobserver repeatability was almost perfect for all three (Madhwal, κ = 0.81; 95% confidence interval [CI], 0.71-0.99; MacDonald, κ = 0.82; 95% CI, 0.72-0.92; Casserly, κ = 0.84; 95% CI, 0.74-0.93). The level of concordance among the different definitions was very low (Madhwal vs MacDonald, 85% [P = .002]; 33% for type III arch; Madhwal vs Casserly, 60% [P < .0001]; 12% for type III arch; MacDonald vs Casserly, 75% [P < .0001]; 12% for type III arch). CONCLUSIONS: The three definitions of the type III arch have a very low level of concordance, which might account for the varying clinical relevance of this configuration. Our findings have relevant implications for risk prediction for carotid artery stenting based on the presence of a type III arch, for comparisons of the results from different studies, and for comparisons of different datasets from multicenter trials.

The financial evolution of endovascular aneurysm repair delivery in contemporary practice.

OBJECTIVE: The fiscal impact of endovascular repair (EVR) of aortic aneurysms and the requisite device costs have previously highlighted the tenuous long-term financial sustainability among Medicare beneficiaries. The Centers for Medicare & Medicaid Services have since reclassified EVR remuneration paradigms with new Medicare Severity Diagnosis-Related Groups (MS-DRGs) intended to better address the procedure's cost profile. The impact of this change remains unknown. The purpose of this analysis was to compare EVR-specific costs and revenue among Medicare beneficiaries both before and after this change. METHODS: All infrarenal EVRs performed in fiscal years (FYs) 2014 and 2015, before the MS-DRG change, and those performed in FYs 2017 and 2018, after the MS-DRG change, were identified using the DRG codes 238 (n = 108) and 269 (n = 84), respectively. We then identified those who were treated according to the instructions for use guidelines with a single manufacturer's device and billed to Medicare (n = 23 in FY14-15; n = 22 in FY17-18). From these cohorts, we determined total procedure technical costs, technical revenue, and net technical margin in conjunction with the hospital finance department. Results were then compared between these two groups. RESULTS: The two cohorts demonstrated similar demographic profiles (FY14-15 vs FY17-18 cohort: age, 78 years vs 74 years; median length of stay, 1.0 day vs 1.0 day). Mean total technical costs were slightly higher in the FY17-18 group ($24,511 in FY14-15 vs $26,445 in FY17-18). Graft implants continued to account for a significant portion of the total cost, with the device cost accounting for 56% of the total procedure costs in both cohorts. Net revenue was greater in the FY17-18 group by $5800 ($30,698 in FY14-15 vs $36,498 in FY17-18), resulting in an increased overall margin in the FY17-18 group compared with the FY14-15 group ($6188 in FY14-15 vs $10,053 in FY17-18). CONCLUSIONS: Device costs remain the single greatest cost driver associated with EVR delivery. DRG reclassification of EVR to address total procedure and implant costs appears to better address the requisite associated procedure costs and may thereby better support long-term fiscal sustainability of this procedure for hospitals and health systems alike.