Image-based assessment of aortoiliac aneurysm anatomical characteristics in patients from the global iliac branch study.

OBJECTIVE: Endovascular repair is the preferred treatment for aortoiliac aneurysm, with preservation of at least one internal iliac artery recommended. This study aimed to assess pre-endovascular repair anatomical characteristics of aortoiliac aneurysm in patients from the Global Iliac Branch Study (GIBS, NCT05607277) to enhance selection criteria for iliac branch devices (IBD) and improve long-term outcomes. METHODS: Pre-treatment CT scans of 297 GIBS patients undergoing endovascular aneurysm repair were analyzed. Measurements included total iliac artery length, common iliac artery length, tortuosity index, common iliac artery splay angle, internal iliac artery stenosis, calcification score, and diameters in the device's landing zone. Statistical tests assessed differences in anatomical measurements and IBD-mediated internal iliac artery preservation. RESULTS: Left total iliac artery length was shorter than right (6.7 mm, P = .0019); right common iliac artery less tortuous (P = .0145). Males exhibited greater tortuosity in the left total iliac artery (P = .0475) and larger diameter in left internal iliac artery's landing zone (P = .0453). Preservation was more common on right (158 unilateral, 34 bilateral) than left (105 unilateral, 34 bilateral). There were 192 right-sided and 139 left-sided IBDs, with 318 IBDs in males and 13 in females. CONCLUSION: This study provides comprehensive pre-treatment iliac anatomy analysis in patients undergoing endovascular repair with IBDs, highlighting differences between sides and sexes. These findings could refine patient selection for IBD placement, potentially enhancing outcomes in aortoiliac aneurysm treatment. However, the limited number of females in the study underscores the need for further research to generalize findings across genders.

Carotid Artery Stenting: JACC State-of-the-Art Review.

Significant advances in the field of carotid artery stenting (CAS) have occurred, including new randomized trial data, recent professional societal statements for competency, new techniques and new devices that have been developed, and perhaps most importantly, our understanding of how to better select candidates for CAS to avoid periprocedural complications. The current Centers for Medicare and Medicaid Services coverage decision regarding CAS is outdated, and our review supports our recommendation to approve CAS in selected candidates who are symptomatic with a carotid stenosis ≥50% and ≤99% and for asymptomatic patients with carotid stenosis ≥70% and ≤99% for stroke prevention. Optimized CAS strategies have allowed experienced operators to better assess procedure risk before CAS and have led to continued improvement in CAS outcomes. New technologies including enhanced embolic protection devices and dual-layered stents should result in further improvement.

IN.PACT AV Access Trial: Economic Evaluation of Drug-Coated Balloon Treatment for Dysfunctional Arteriovenous Fistulae Based on 12-Month Clinical Outcomes.

PURPOSE: To study, from a U.S. payer's perspective, the economic consequences of drug-coated balloon (DCB) versus standard percutaneous transluminal angioplasty (PTA) use for the treatment of stenotic lesions in dysfunctional hemodialysis arteriovenous fistulae. MATERIALS AND METHODS: Cost differences between DCBs and PTA at year 1 and beyond were calculated via 2 methods. The first approach used the mean absolute number of trial-observed access circuit reinterventions through 12 months (0.65 ± 1.05 vs 1.05 ± 1.18 events per patient for DCBs and PTA, respectively) and projected treatment outcomes to 3 years. The second approach was based on the trial-observed access circuit primary patency rates at 12 months (53.8% vs 32.4%) and calculated the cost difference on the basis of previously published Medicare cost for patients who maintained or did not maintain primary patency. Assumptions regarding DCB device prices were tested in sensitivity analyses, and the numbers needed to treat were calculated. RESULTS: Using the absolute number of access circuit reinterventions approach, the DCB strategy resulted in an estimated per-patient savings of $1,632 at 1 year and $4,263 at 3 years before considering the DCB device cost. The access circuit primary patency approach was associated with a per-patient cost savings of $2,152 at 1 year and $3,894 at 2.5 years of follow-up. At the theoretical DCB device reimbursement of $1,800, savings were $1,680 and $2,049 at 2.5 and 3 years, respectively. The one-year NNT of DCB compared to PTA was 2.48. CONCLUSIONS: Endovascular therapy for arteriovenous access stenosis with the IN.PACT AV DCB can be expected to be cost-saving if longer follow-up data confirm its clinical effectiveness.

Improving clinical documentation of evaluation and management care and patient acuity improves reimbursement as well as quality metrics.

OBJECTIVE: Accurate documentation of patient care and acuity is essential to determine appropriate reimbursement as well as accuracy of key publicly reported quality metrics. We sought to investigate the impact of standardized note templates by inpatient advanced practice providers (APPs) on evaluation and management (E/M) charge capture, including outside of the global surgical package (GSP), and quality metrics including case mix index (CMI) and mortality index (MI). We hypothesized this clinical documentation initiative as well as improved coding of E/M services would result in increased reimbursement and quality metrics. METHODS: A documentation and coding initiative on the heart and vascular service line was initiated in 2016 with focus on improving inpatient E/M capture by APPs outside the GSP. Comprehensive training sessions and standardized documentation templates were created and implemented in the electronic medical record. Subsequent hospital care E/M (current procedural terminology codes 99231, 99232, 99233) from the years 2015 to 2017 were audited and analyzed for charge capture rates, collections, work relative value units (wRVUs), and billing complexity. Data were compared over time by standardizing CMS values and reimbursement rates. In addition, overall CMI and MI were calculated each year. RESULTS: One year following the documentation initiative, E/M charges on the vascular surgery service line increased by 78.5% with a corresponding increase in APP charges from 0.4% of billable E/M services to 70.4% when compared with pre-initiative data. The charge capture of E/M services among all inpatients rose from 21.4% to 37.9%. Additionally, reimbursement from CMS increased by 65% as total work relative value units generated from E/M services rose by 78.4% (797 to 1422). The MI decreased over the study period by 25.4%. Additionally, there was a corresponding 5.6% increase in the cohort CMI. Distribution of E/M encounter charges did not vary significantly. Meanwhile, the prevalence of 14 clinical comorbidities in our cohort as well as length of stay (P = .88) remained non-statistically different throughout the study period. CONCLUSIONS: Accurate clinical documentation of E/M care and ultimately inpatient acuity is critical in determining quality metrics that serve as important measures of overall hospital quality for CMS value-based payments and rankings. A system-based documentation initiative and expanded role of inpatient APPs on vascular surgery teams significantly improved charge capture and reimbursement outside the GSP as well as CMI and MI in a consistently complex patient population.

Incidence and management of iliac artery aneurysms associated with endovascular treatment of juxtarenal and thoracoabdominal aortic aneurysms.

BACKGROUND: This study reports the clinical impact of iliac artery aneurysms (IAAs) in a population of patients with juxtarenal and thoracoabdominal aortic aneurysms being treated with fenestrated or branched aortic endografts. METHODS: Data from 364 patients with IAA (33%) were extracted from the 1118 patients treated for juxtarenal or thoracoabdominal aortic aneurysms with a fenestrated or branched aortic endograft in a physician-sponsored investigational device exemption trial (2001-2016). IAAs were defined as ≥21 mm in diameter, as measured by an imaging core laboratory. Outcomes were assessed by univariate and multivariable analysis. RESULTS: IAAs were unilateral in 219 (60%) and bilateral in 145 (40%) of the 364 patients. Treatment was iliac leg endoprosthesis without coverage of the hypogastric artery (seal distal to the IAA in the common iliac artery), placement of a hypogastric branched endograft in 105 (21%), and hypogastric artery coverage with extension into the external iliac artery in 103 (20%); 67 (13%) were untreated. Procedure duration was longer for those with IAA (5.3 ± 1.79 hours vs 4.6 ± 1.74 hours; P < .001), although hospital stay was not. There was no difference in aneurysm-related mortality and all-cause mortality for patients with unilateral and bilateral IAAs compared with those without an IAA. Treatment of patients with a hypogastric branched endograft had similar all-cause mortality compared with treatment of patients without a hypogastric branched endograft but also with an IAA. Reintervention rates were significantly higher in those with bilateral IAAs compared with no IAA (hazard ratio, 1.886; P < .001). Spinal cord ischemia trended higher in patients with bilateral IAA. CONCLUSIONS: IAA management at the time of fenestrated or branched endovascular aneurysm repair increases procedure time without increasing hospitalization. The reintervention rate and spinal cord ischemia rate are higher in patients with bilateral IAA compared with those with no IAA.

Carotid Artery Stenting in Asymptomatic Carotid Artery Stenosis: JACC Review Topic of the Week.

The advance of therapies to reduce the stroke impact of asymptomatic carotid artery stenosis has proved difficult over the last decade. Disagreement concerning the underlying randomized control trials has limited entry into the care arena of endovascular therapies. Recently, advances in percutaneous therapies for carotid artery disease have been reported and provide a substantial database supporting the further incorporation of endovascular-based therapies in patients who need revascularization and meet selection criteria. With a second randomized control trial now published, it is time for a re-evaluation of endovascular therapy as a component of carotid artery care. This review describes the advances in the field in the last 5 years, clarifying the current position of these therapies in the care of the patient with asymptomatic carotid artery disease.

Mortality Assessment of Paclitaxel-Coated Balloons: Patient-Level Meta-Analysis of the ILLUMENATE Clinical Program at 3 Years.

BACKGROUND: A recent summary-level meta-analysis comprising randomized, controlled trials (RCTs) of femoropopliteal paclitaxel-coated balloon and stent intervention identified excess late mortality in the paclitaxel-treated patients. METHODS: We evaluated the safety of the Stellarex drug-coated balloon (DCB) for femoropopliteal artery disease with an independently performed meta-analysis of patient-level data from all patients in the Stellarex femoropopliteal clinical program. To compare mortality after DCB or uncoated percutaneous transluminal angioplasty (PTA), we aggregated data from 2 RCTs comprising 419 patients treated with DCB and 170 patients treated with PTA. In an additional analysis, data were aggregated from 6 poolable Stellarex DCB studies (2 RCTs, 3 single-arm studies, and 1 registry). All serious adverse events including deaths were adjudicated by a blinded, third-party, independent Clinical Events Committee. Kaplan-Meier estimates in the RCTs were compared with restricted mean survival time. Predictors of death were assessed with hazard ratios (HRs) and Cox proportional hazards modeling. RESULTS: Baseline characteristics were similar in the patients treated with DCB and PTA in the pooled RCT analysis, with the exception that the DCB cohort was younger (67.4±9.7 versus 69.4±9.4 years, P=0.02), smoked more frequently (86.6% versus 78.8%, P=0.02), and were less often treated for recurrent lesions (8.8% versus 14.7%, P=0.04). In the RCTs, patients treated with DCB had all-cause mortality rates that were not different from those of patients treated with PTA (Kaplan-Meier estimates 1.8±0.7% versus 1.3±0.9%, 6.5±1.2% versus 5.9±1.9%, and 9.3±1.5% versus 9.9±2.4% at 1, 2, and 3 years, respectively, P=0.86). All-cause mortality rates were similar in a 1906-patient pooled nonrandomized DCB data set (Kaplan-Meier estimates of 2.1%, 4.9%, and 7.0% at 1, 2, and 3 years, respectively). Clinical Events Committee-adjudicated causes of death were balanced between the DCB and PTA cohorts. Multivariable Cox modeling identified age (HR, 1.06; 95% CI, 1.04-1.08; P<0.001), diabetes mellitus (HR, 1.42; 95% CI, 1.01-2.00; P=0.04), congestive heart failure (HR, 1.88; 95% CI, 1.12-3.16; P=0.02), and renal insufficiency (HR, 2.00; 95% CI, 1.33-3.01; P<0.001) as predictors of mortality. Paclitaxel exposure was unrelated to mortality (HR, 1.04; 95% CI, 0.98-1.10; P=0.23). CONCLUSIONS: The mortality rates for patients treated with the DCB and uncoated PTA were indistinguishable over 3-year follow-up. Additional patient-level, adequately powered meta-analyses with larger RCT data sets will be needed to confirm the generalizability of these findings. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifiers: NCT02110524, NCT01858363, NCT01858428, NCT03421561, NCT01912937, NCT01927068, and NCT02769273.

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.