Peripheral Arterial Interventions Research Articles

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

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

Evidence-based interventions for identifying candidate quality indicators to assess quality of care in diabetic foot clinics: a scoping review.

Foot ulcers in people with diabetes are a serious complication requiring a complex management and have a high societal impact. Quality monitoring systems to optimize diabetic foot care exist, but a formal and more evidence-based approach to develop quality indicators (QIs) is lacking. We aimed to identify a set of candidate indicators for diabetic foot care by adopting an evidence-based methodology. A systematic search was conducted across four academic databases: PubMed, Embase CINAHL and Cochrane Library. Studies that reported evidence-based interventions related to organization or delivery of diabetic foot care were searched. Data from the eligible studies were summarized and used to formulate process and structure indicators. The evidence for each candidate QI was described in a methodical and transparent manner. The review process was reported according to the "Preferred Reported Items for Systematic reviews and Meta-Analysis" (PRISMA) statements and its extension for scoping reviews. In total, 981 full-text articles were screened, and 322 clinical studies were used to formulate 42 candidate QIs. An evidence-based approach could be used to select candidate indicators for diabetic foot ulcer care, relating to the following domains: wound healing interventions, peripheral artery disease, offloading, secondary prevention, and interventions related to organization of care. In a further step, the feasibility of the identified set of indicators will be assessed by a multidisciplinary panel of diabetic foot care stakeholders.

Radial Artery Access for Peripheral Vascular Interventions: A Review of the Literature

ObjectivePercutaneous radial artery access for lower extremity arterial interventions has increased in popularity in recent years. The purpose of this review is to summarize available data regarding its safety and efficacy. MethodsStudies related to the use of the percutaneous radial artery access for peripheral artery intervention were identified in a search of the PubMed database. Outcomes evaluated were access complications and technical success. ResultsThirteen studies that evaluated patients undergoing percutaneous radial artery access with peripheral interventions were reviewed. Several studies were able to demonstrate use of up to 8Fr sheath; however, the majority was 6Fr. Reported rates of asymptomatic radial artery occlusion ranged up to 16% and reported radial artery access site complication rate ranged from 0-15.6%. Technical success ranged from 74%-98.7%. ConclusionsPercutaneous radial artery access can effectively and safely be used in select patients.

Intravascular ultrasound use in peripheral arterial and deep venous interventions: Multidisciplinary expert opinion from SCAI/AVF/AVLS/SIR/SVM/SVS

Percutaneous revascularization is the primary strategy for treating lower extremity venous and arterial disease. Angiography is limited by its ability to accurately size vessels, precisely determine the degree of stenosis and length of lesions, characterize lesion morphology, or correctly diagnose postintervention complications. These limitations are overcome with use of intravascular ultrasound (IVUS). IVUS has demonstrated the ability to improve outcomes following percutaneous coronary intervention, and there is increasing evidence to support its benefits in the setting of peripheral vascular intervention. At this stage in its evolution, there remains a need to standardize the use and approach to peripheral vascular IVUS imaging. This manuscript represents considerations and consensus perspectives that emerged from a roundtable discussion including 15 physicians with expertise in interventional cardiology, interventional radiology, and vascular surgery, representing 6 cardiovascular specialty societies, held on February 3, 2023. The roundtable’s aims were to assess the current state of lower extremity revascularization, identify knowledge gaps and need for evidence, and determine how IVUS can improve care and outcomes for patients with peripheral arterial and deep venous pathology.

The Additional Value of Activated Clotting Time-Guided Heparinization During Interventions for Peripheral Arterial Disease.

Unfractionated heparin is widely used to lower the risk of arterial thromboembolic complications (ATECs) during interventions for peripheral arterial disease (PAD), but it is still unknown which heparin dose is the safest in terms of preventing ATECs and bleeding complications. This study aims to evaluate the incidence of complications during interventions for PAD and the relation between this incidence and different heparinization protocols. A retrospective analysis of a prospective multicenter cohort study was performed. Between June 2015 and September 2022, 355 patients who underwent peripheral interventions for PAD were included. All patients who were included before July 2018 received 5000 international units (IU) of heparin (group 1). Starting from July 2018, all included patients received an initial dose of 100 IU/kg, with potential additional heparin doses based on activated clotting time (ACT) values (group 2). Data on ACT values and complications within 30 days post-procedurally were collected. In total, 24 ATECs and 48 bleeding complications occurred. In group 1, 8.7% (n=11) of patients suffered from ATEC, compared with 5.7% (n=13) in group 2. Thirteen percent of patients (n=17) in group 1 had a bleeding complication, compared with 14% (n=31) in group 2. Arterial thromboembolic complications were more often found in patients with peak ACT values of <200 seconds, compared with ACT values between 200 and 250 seconds, 15% (n=6) versus 5.9% (n=9), respectively, p=0.048. Patients with peak ACT values >250 seconds had a higher incidence of bleeding complications compared with an ACT between 200 and 250 seconds, 24% (n=21) versus 9.8% (n=15), respectively, p=0.003. Forty-four percent of patients (n=23) in group 1 reached a peak ACT of >200 seconds, compared with 95% (n=218) of patients in group 2 (p=0.001). ATEC was found in 6.8% (n=24) and bleeding complications in 14% (n=48) of patients who underwent a procedure for PAD. There was a significantly higher incidence of ATECs in patients with a peak ACT value <200 seconds, and a higher incidence of bleeding complications in patients with a peak ACT value >250 seconds. The findings obtained from this study may serve as a basis for conducting future research on heparinization during procedures for PAD, with a larger sample size. Heparin is administered during arterial interventions for peripheral arterial disease (PAD) to decrease the risk of arterial (thrombo)embolic complications (ATEC) during or shortly following surgery. The effect of heparin is unpredictable in the individual patient, and the optimal dosage of this anticoagulant has not yet been established. Using the activated clotting time (ACT), the anticoagulatory effect of heparin can be monitored periprocedurally. Previous research on the incidence of both ATEC and bleeding complications, or on the optimal dosage of heparin administration, is scarce. This study aims to investigate the incidence of ATEC and bleeding complications between 2 different dosage protocols of heparin-a standard bolus of 5000 IU or ACT-guided heparinization-and thereby provide clarity on the optimal dose of heparin during peripheral arterial interventions for PAD.

Abstract 15540: Comparative Outcomes of Femoropopliteal Intravascular Ultrasound Interventions: A Report From the XLPAD Registry

Background: Intravascular ultrasound (IVUS) during peripheral artery intervention is being increasingly used, however there is limited real-world procedural and outcomes data. Methods: We examined 4847 patients from the XLPAD Registry (NCT01904851) from 2006-2021 that underwent femoropopliteal (FP) endovascular intervention. The primary outcome was the incidence of major adverse limb events (MALE), which includes death, clinically driven revascularization, amputation, myocardial infarction (MI), and stroke. Comparative analyses were done between patients with IVUS and no IVUS interventions. Results: 322 (6.6%) patients underwent an IVUS guided FP intervention and 4525 without. Mean age 67, predominantly men (83% IVUS-group vs. 71% non-IVUS, p&lt;0.0001) and Caucasian (71% vs. 69%, p=NS). IVUS patients had worse risk profiles, with more smokers (59% vs. 47 %, p&lt;0.0001), heart failure (20% vs. 14%, p=0.006) and prior-MI (31% vs. 22%, p&lt;0.0001), and similar proportion of hypertensives, diabetics, dyslipidemics, or those with chronic kidney disease. IVUS patients had more multivessel intervention (2.4 vs. 1.9 lesions, p&lt;0.0001), SFA being the most common artery, followed by the popliteal artery in both groups. Balloon angioplasty was more common in the non-IVUS group (68% vs. 75%, p=0.005), whereas drug coated balloons (19% vs. 12%, p=0.005), drug-eluting stents (15 vs. 9%, p=0.001) and vascular mimetic stents (13 vs. 4%, p&lt;0.0001) were more frequent in the IVUS patients. Fluoroscopy time was longer in IVUS patients (35 min vs 30 min., p=0.005) with similar rates of procedural (90% vs. 93, p=NS) and technical success (94% vs. 95%, p=NS). There were no differences in peri-procedural complications, or 12-month MALE (21% vs. 20%, p=NS). Only death from any cause was significantly higher in the non-IVUS group (0.7 vs 3.0%, p=0.017). Conclusion: IVUS use is under 7% of all FP interventions in the XLPAD registry with IVUS guidance is used in patients with more adverse clinical risk profile, however with no difference in technical, procedural success and 12-month MALE events.

Radiation doses in endovascular revascularisation of lower-extremity arterial diseases.

The use of percutaneous endovascular intervention in lower-extremity arterial diseases is increasing daily. With the growing technical experience of vascular surgeons, this is preferred to open surgery in more complex lesions. The dose area product (DAP) and fluoro (FL) time values of 150 patients who underwent successful peripheral endovascular arterial intervention were analysed retrospectively. These values were evaluated by grouping according to the anatomical region and complexity of the lesion, type of procedure and arterial access. While the mean DAP was 18 ± 27 Gy cm2 in patients who underwent only angioplasty, it was 21 ± 17 Gy cm2 in patients who underwent stent implantation after angioplasty ( p = 0.069). The DAP value was statistically significantly higher in patients who had intervention in the pelvic region, both in the angioplasty (23 ± 22 Gy cm2) group and in the stenting (29 ± 18 Gy cm2) group, than in patients who had intervention in the femoropopliteal region (18 ± 27 and 15 ± 12 Gy cm2, respectively) (p < 0.05). When the correlation between body mass index (BMI) of the patients and DAP was examined, a moderate positive correlation was found both in the pelvic region (r = 0.601, p = 0.00) and in the femoropopliteal region (r = 0.512, p = 0.00). Out of 78 patients in whom the ipsilateral popliteal retrograde approach was preferred, only two developed arteriovenous fistulae after the procedure, and only two of 77 patients in whom the femoral approach was preferred developed no major or minor complications, except femoral pseudo-aneurysm. The most important factors affecting the radiation doses of the patients were the anatomical region and the patient's BMI. Radiation doses were higher in pelvic interventions compared to the femoropopliteal region. This may encourage the choice of arterial approaches that can minimise visualisation of the pelvic region in particular. Therefore, attention should be paid to pre-operative planning, especially in patients undergoing multiple diagnostic and therapeutic imaging. The ipsilateral popliteal retrograde approach can be safely chosen in combined iliofemoral, common femoral and superficial femoral total occlusions in the hands of surgeons with good Doppler ultrasonography experience.

Prospective, Multicenter Registry to Assess Safety and Efficacy of Radial Access for Peripheral Artery Interventions

Prospective, Multicenter Registry to Assess Safety and Efficacy of Radial Access for Peripheral Artery Interventions

Witnessing the Evolution of Peripheral Arterial Disease Interventions: Survival of the Fit, Diversity, Adaptation to Environmental Niches, and Missing Links

Witnessing the Evolution of Peripheral Arterial Disease Interventions: Survival of the Fit, Diversity, Adaptation to Environmental Niches, and Missing Links

Safety and efficacy of the CELT ACD femoral arteriotomy closure device in the office-based laboratory.

Manual compression remains the gold standard for achieving hemostasis for percutaneous common femoral artery access. However, it requires prolonged bedrest and 20 to 30minutes or more of compression for hemostasis. Current arterial closure devices have emerged in recent years, but patients still require prolonged bedrest and time to ambulation and discharge, and these devices are associated with significant access device complications, including hematoma, retroperitoneal bleeding, transfusion requirement, pseudoaneurysm, arteriovenous fistula, and arterial thrombosis. A novel femoral access closure device, the CELT ACD (Vasorum Ltd, Dublin, Ireland), has been previously shown to reduce these complication rates and allow rapid hemostasis, require little or no bedrest, and shortened time to ambulation and discharge. This is especially advantageous in the outpatient setting. We report our initial experience with this device. A prospective single-center single-arm study was performed in an office-based laboratory setting to assess the safety and efficacy of the CELT ACD closure device. Patients underwent diagnostic and therapeutic peripheral arterial procedures from retrograde or antegrade common femoral artery access. Primary endpoints include device deployment success, time to hemostasis, and major or minor complications. Secondary endpoints include time to ambulation and time to discharge. Major complications were defined as bleeding requiring hospitalization or blood transfusion, device embolization, pseudoaneurysm formation, and limb ischemia. Minor complications were defined as bleeding not requiring hospitalization/blood transfusion, device malfunction, and access site infection. A total of 442 patients were enrolled with common femoral access only. Median age was 78years (range, 48-91years), and 64% were male. Heparin was given in all cases, with median heparin dose of 6000 units (range, 3000-10,000 units). Protamine reversal was used in 10 cases due to minor soft tissue bleeding. Average time to hemostasis was 12.1seconds (±13.2seconds), time to ambulation was 17.1minutes (±5.2minutes), and time to discharge was 31.7minutes (±8.9minutes). All devices (100%) were deployed successfully. No major complications occurred (0%). Ten minor complications (2.3%) occurred; all were minor soft tissue bleeding from the access site that resolved with protamine reversal of heparin and manual compression. The CELT ACD closure device is safe and easily deployed with a very low complication rate, and significantly reduces time to hemostasis, ambulation, and discharge in patients undergoing peripheral arterial intervention from a common femoral artery approach in the office-based laboratory setting. This is a promising device that deserves further evaluation.

A Framework for Characterizing Delays in Urgent Peripheral Arterial Disease Interventions

A Framework for Characterizing Delays in Urgent Peripheral Arterial Disease Interventions

Evaluation of the MYNX CONTROL™ Arterial Closure System for Achieving Primary Hemostasis after Arterial Femoral Access Following Peripheral Arterial Interventions, Compared to the FemoSealTM Closure System.

Background: In addition to manual compression, various vascular closure devices (VCD) are available to seal the puncture site following arterial vascular procedures. Purpose: To evaluate the efficacy and safety of the extravascular MYNX CONTROL closure system for achieving primary hemostasis after femoral arterial access following peripheral arterial procedures, compared to the intravascular FemoSeal Aclosure system. Patients and Methods: A retrospective analysis of consecutive patients who underwent endovascular intervention between April and November 2022 was performed. The primary endpoint was the incidence of significant puncture site complication defined as a complication resulting in medical treatment. Secondary endpoints included peri-interventional incidence of hematoma, peri-interventional changes in hemoglobin, incidence of emergency diagnostics and predictors for closure system failure. Results: Five hundred and forty-eight patients were included in this analysis. False aneurysm occurred in 18/273 cases (6.6%) following the use of the MYNX closure system, compared to 6/275 cases after using the FemoSeal closure system (2.2%, p = 0.006). The incidence of post-interventional hematoma was not significantly different (28 (10.3%) in the MYNX group versus 32 (11.6%) in the FemoSeal group, p = 0.358). Peri-interventional hemoglobin drop did not differ between groups (p = 0.449). Emergency diagnostics were not significantly performed more often in the MYNX group (14 (5.1%) versus 8 (2.9%), p = 0.134). A post-interventional duplex sonography showed stenosis at the puncture site in one patient after use of the MYNX system. For the entire cohort, oral anticoagulation was the only predictor for the failure of the closure device (p = 0.036). Conclusions: Device failure was more common after using the extravascular MYNX CONTROL system than after using the intravascular FemoSeal system. However, the need for surgical or interventional therapy due to device failure was low.

Consensus minimum core data elements adapted to peripheral vascular intervention in the drug-eluting era: Consensus report from the Registry Assessment of Peripheral Interventional Devices (RAPID) Pathways “LEAN” working group

Registry Assessment of Peripheral Interventional Devices (RAPID) initiated the Pathways Program to provide a transparent, collaborative forum in which to pursue insights into multiple unresolved questions on benefit-risk of paclitaxel-coated devices, including understanding the basis of the mortality signal, without a demonstrable potential biological mechanism, and whether the late mortality signal could be artifact intrinsic to multiple independent prospective randomized data sources that did not prespecify death as a long-term end point. In response to the directive, the LEAN-Case Report Form working group focused on enhancements to the RAPID Phase I Minimum Core Data set through the addition of key clinical modifiers that would be more strongly linked to longer-term mortality outcomes after peripheral arterial disease intervention in the drug-eluting device era, with the goal to have future mortality signals more accurately examined.

A Novel Endovascular Robotic System for Treatment of Lower Extremity Peripheral Arterial Disease: First-in-Human Experience.

To assess the feasibility and first-in-human experience of a novel endovascular robotic system for treatment of lower extremity peripheral arterial disease (PAD). Between November 2021 and January 2022, consecutive patients with obstructive lower extremity PAD and claudication (Rutherford 2-5) with >50% stenosis demonstrated on angiography were enrolled in this study. Lower extremity peripheral arterial intervention was performed using the endovascular robotic system, which consisted of a bedside unit and an interventional console. The primary endpoints were technical success, defined as the successful manipulation of the lower extremity peripheral arterial devices using the robotic system, and safety. The secondary endpoints were clinical success, defined as 50% residual stenosis at the completion of the robot-assisted procedure without major adverse cardiac events and radiation exposure. In total, 5 patients with PAD were enrolled in this study (69.2±6.0 years; 80% men). The novel endovascular robotic system successfully completed the entire procedure of endovascular treatment of lower extremity PAD. Conversion to manual operation, including advancement, retracement, rotation of the guidewires, catheters, sheaths, deployment, and release of the balloons and stent grafts, was not necessary. We achieved the criteria for clinical procedural and technical success in all patients. No deaths, myocardial infarctions, or ruptures occurred in the period up to 30 days after the procedure, and no device-related complications were observed. The robotic system operator had 97.6% less radiation exposure than that at the procedure table, with a mean of 1.40±0.49 μGy. This study demonstrated the safety and feasibility of the robotic system. The procedure reached technical and clinical performance metrics and resulted in significantly lower radiation exposure to the operators at the console compared with that at the procedure table. There were some reports about several robotic systems used in the peripheral arterial disease, but no robotic system was able to perform entire procedure of endovascular treatment of lower extremity peripheral arterial disease (PAD).To solve this problem, we designed a remote-control novel endovascular robotic system. It was the first robotic system that can perform entire procedure of endovascular treatment of PAD worldwide. A novelty retrieval report about this is provided in the supplementary materials.The robotic system is compatible with all commercial endovascular surgical devices currently available in the market, including guidewires, catheters and stent delivery systems. It can perform all types of motion, such as forward, backward, and rotation to meet the requirements of all types of endovascular procedures. During the operation, the robotic system can perform these operations in a fine-tuned manner, so it is easy to cross the lesions, which is the key factor influencing the success rate of the operation. In addition, the robotic system can effectively reduce the exposure time to radiation, thereby reducing the risk of occupational injury.

Racial Differences in Presentation and Outcomes After Peripheral Arterial Interventions: Insights From the NCDR-PVI Registry.

We assess the rates of device use and outcomes by race among patients undergoing lower extremity peripheral arterial intervention using the American College of Cardiology National Cardiovascular Data Registry-Peripheral Vascular Intervention (PVI) registry. Patients who underwent PVI between April 2014 and March 2019 were included. Socioeconomic status was evaluated using the Distressed Community Index score for patients' zip codes. Multivariable logistic regression was used to assess factors associated with utilization of drug-eluting technologies, intravascular imaging, and atherectomy. Among patients with Centers for Medicare and Medicaid Services data, we compared 1-year mortality, rates of amputation, and repeat revascularizations. Of 63 150 study cases, 55 719 (88.2%) were performed in White patients and 7431 (11.8%) in Black patients. Black patients were younger (67.9 versus 70.0 years), had higher rates of hypertension (94.4% versus 89.5%), diabetes (63.0% versus 46.2%), less likely to be able to walk 200 m (29.1% versus 24.8%), and higher Distressed Community Index scores (65.1 versus 50.6). Black patients were provided drug-eluting technologies at a higher rate (adjusted odds ratio, 1.14 [95% CI, 1.06-1.23]) with no difference in atherectomy (adjusted odds ratio, 0.98 [95% CI, 0.91-1.05]) or intravascular imaging (adjusted odds ratio, 1.03 [95% CI, 0.88-1.22]) use. Black patients experienced a lower rate of acute kidney injury (adjusted odds ratio, 0.79 [95% CI, 0.72-0.88]). In Centers for Medicare and Medicaid Services-linked analyses of 7429 cases (11.8%), Black patients were significantly less likely to have surgical (adjusted hazard ratio, 0.40 [95% CI, 0.17-0.96]) or repeat PVI revascularization (adjusted hazard ratio, 0.42 [95% CI, 0.30-0.59]) at 1 year compared with White patients. There was no difference in mortality (adjusted hazard ratio [0.8-1.4]) or major amputation (adjusted hazard ratio, 2.5 [95% CI, 0.8-7.6]) between Black and White patients. Black patients presenting for PVI were younger, had higher prevalence of comorbidities and lower socioeconomic status. After adjustment, Black patients were less likely to have surgical or repeat PVI revascularization after the index PVI procedure.

Reproducibility of Femoropopliteal Artery Intravascular Ultrasound Imaging in Patients With Peripheral Artery Disease

Despite increased use of intravascular ultrasound (IVUS) during peripheral artery interventions, evidence for reproducibility of IVUS measurements and its relation to angiography is lacking. Forty cross-sectional IVUS images of the femoropopliteal artery from 20 randomly selected patients enrolled in the XLPAD (Excellence in Peripheral Artery Disease) registry who underwent peripheral artery interventions and met criteria based on IVUS consensus guidelines were independently assessed by 2 blinded readers. IVUS images from 6 patients (40 images) were selected for angiographic correlation and met criteria for identifiable landmarks (e.g., stent edge and bifurcation). Lumen cross-sectional area (CSA), external elastic membrane (EEM) CSA, luminal diameter, and reference vessel diameter were repeatedly measured. The Lumen CSA and EEM CSA intra-observer agreement by Spearman rank-order correlation (ρ) was >0.993, intraclass correlation coefficient was >0.997, and repeatability coefficient was <1.34. For the interobserver measurement of luminal CSA and EEM CSA, the ρ=0.742 and 0.764; intraclass correlation coefficient=0.888 and 0.885; and repeatability coefficient=7.24 and 11.34, respectively. A Bland-Altman plot for lumen and EEM CSA showed good reproducibility. For angiographic comparison, the ρ for luminal diameter, luminal area, and vessel area were 0.419, 0.414, and 0.649, respectively. Femoropopliteal IVUS measurements showed strong intra-observer and interobserver agreement; IVUS and angiographic measurements did not demonstrate a similar strong agreement.

Implementation and Evaluation of a Comprehensive Simulation Curriculum for the IR/DR Integrated Residency

Endovascular simulation is a validated training method, allowing residents to improve technical skills with interventional equipment in a risk-free environment. The purpose of this study was to assess the utility and efficacy of supplementing the IR/DR Integrated Residency training program with a dedicated 2-year endovascular simulation curriculum. Trainees participated in a 2-year curriculum that included the completion of 8 modules using a high-fidelity endovascular simulator (Mentice AB, Gothenberg, Sweden). Procedural modules included IVC filter placement, transarterial chemoembolization, trauma embolization, uterine artery embolization, prostate artery embolization, and peripheral arterial disease interventions. Each quarter, two trainees were filmed while completing an assigned module. Sessions led by IR faculty were held with film footage review and didactics on the assigned topic. Pre- and postcase surveys were collected to evaluate trainee comfort and confidence and assess the validity of the simulation. At the conclusion of the 2-year period, a postcurriculum survey was sent to all trainees to determine how residents viewed the utility of the simulation sessions. Eight residents participated in the pre- and postcase surveys. The simulation curriculum significantly increased trainee confidence for these 8 residents. A separate postcurriculum survey was completed by all 16 IR/DR residents. All 16 residents felt that simulation was a helpful addition to their education. A total of 87.5% of all residents felt that the sessions improved their confidence in the IR procedure room. A total of 75% of all residents believe that the simulation curriculum should be incorporated into the IR residency program. Adoption of a 2-year simulation curriculum can be considered for existing IR/DR training programs with access to high-fidelity endovascular simulators using the described approach.

Endovascular treatment of a critical common iliac artery stenosis using intravascular ultrasound guidance in a patient with a known severe iodine contrast allergy

Introduction: The mainstay of endovascular treatment in peripheral arterial disease is digital subtraction angiography with an iodinated contrast. In patients with a known contrast allergy, the current most commonly used alternative is to perform carbon dioxide angiography. Operator experience and availability of carbon dioxide (CO2) angiography delivery systems are, however, limited. Intravascular ultrasound is now commonly used in combination with fluoroscopy in peripheral venous interventions and in coronary arterial disease and we propose that this also provides a safe and effective alternative option to guide endovascular intervention in patients with a known contrast allergy. Case report: We present a case describing the use of intravascular ultrasound and fluoroscopy to guide endovascular treatment of a critical left common iliac artery stenosis in a patient with known anaphylaxis to iodinated contrast. Discussion: Intravascular ultrasound is fast becoming the gold standard treatment option in peripheral venous interventions; however, the use in peripheral arterial disease is limited. We believe this is the first case that reports the use of predominantly intravascular ultrasound in endovascular peripheral arterial intervention with a contrast adjunct. Conclusion: We have demonstrated that intravascular ultrasound is a safe and effective alternative or adjunct to iodinated contrast for arterial angiography and stenting in the setting of patient contra-indications.

Temporal Trends, Practice Variation, and Associated Outcomes With IVUS Use During Peripheral Arterial Intervention

BackgroundIntravascular ultrasound (IVUS) has been shown in limited prospective studies to improve procedural outcomes for patients undergoing lower extremity peripheral arterial intervention (PVI). ObjectivesThe authors aimed to study temporal trends, practice variation, and associated outcomes with the use of IVUS during PVI among Medicare beneficiaries. MethodsAll PVIs performed from 2016 to 2019 among Medicare beneficiaries aged >65 years were included. Temporal trends in IVUS use were stratified by procedural location (inpatient, outpatient, or ambulatory surgery center [ASC]/office-based laboratory [OBL]) and physician specialty. The primary outcome was major adverse limb events (MALE). Inverse probability weighting was used to account for differences in baseline characteristics. Cox regression with competing risks was used to estimate weighted hazard ratios. ResultsDuring the study period, 543,488 PVIs were included, of which 63,372 (11.7%) used IVUS. A substantial growth in IVUS use was observed, which was driven by procedures performed in ASCs/OBLs (23.6% increase from quarter 1 of 2016 through quarter 4 of 2019). Among operators who used IVUS, there was also notable variation in use (median operator use 5.4% of cases; IQR: 2.2%-15.0%; range, <1%-100%). In weighted analysis, IVUS use during PVI was associated with a lower risk of MALE through a median of 514 days (adjusted hazard ratio: 0.73; 95% CI: 0.70-0.75; P < 0.0001). ConclusionsIn contemporary nationwide data, IVUS use during PVI has increased since 2016, driven by growth in the ASC/OBL setting. However, there remains substantial variation in operator practice. When used during PVI, IVUS was associated with a lower risk of short- and long-term MALE.

Expected changes in physician outpatient interventional practices as a result of coronavirus disease 2019 and recent changes in Medicare physician fee schedule

ObjectiveWe examined the economic and practice effects of the coronavirus disease 2019 (COVID-19) pandemic and decreased Medicare physician payments on outpatient vascular interventional procedures. MethodsA 21-point survey was constructed and sent electronically to the physician members of the Outpatient Endovascular and Interventional Society and the American Vein and Lymphatic Society. The survey responses were converted to a Likert scale and statistical analyses performed to examine the associations between the response variables and the characteristics and practice patterns of the physician respondents. ResultsA total of 165 physicians responded to the survey, of whom 33% were vascular surgeons, 18% were radiologists, and 15% were general surgeons. For slightly more than one half (55%), their interventional practice was limited to the office setting, with the remainder also performing procedures in an office-based laboratory (OBL), ambulatory surgery center (ASC), or hospital. Almost all respondents had performed superficial venous interventions, with slightly more than one third also performing either deep venous procedures and/or peripheral arterial interventions. The COVID-19 pandemic had affected 98% of the practices, with a staff shortage reported by 63%. The most-established physicians, those with the longest interval since training completion, were the least likely to have experienced staff shortages. Almost all (94%) the respondents expected that the recent Medicare payment changes will have a negative effect on their practice. Physicians with only an office-based practice were less likely to add a physician associate compared with those with an OBL (P = .036). More than one quarter reported that it was likely they would close or sell their interventional practice in the next 2 years and 43% reported they were planning to retire early. The anticipated ameliorative responses to the decreased Medicare physician payments included adding wound care (24%) or other clinical services (36%) to their practices, with the alternatives considered more by younger physicians (P = .002) and nonsurgeons (P = .047). Only 10% expected to convert their practices to an ASC or hybrid ASC/OBL (16%). ConclusionsThe emotional and economic effects of the COVID-19 pandemic and the decreased Medicare physician reimbursement rates for vascular outpatient interventionalists have been significant. Even greater challenges for the financial viability of office practices and OBLs can be expected in the near future if additional further planned cuts are put into effect.