A dramatic increase in the number of vascular procedures performed in the office-based laboratory setting has been observed since 2008, when the Centers for Medicare and Medicaid Services increased reimbursement for procedures performed in the ambulatory setting. We sought to evaluate the appropriateness of arterial intervention in the office-based laboratory and patient selection. This systematic review was conducted with a search of Google Scholar and PubMed using the following search terms: office-based lab, outpatient, angioplasty, patient selection, arterial, and appropriateness. More than 500 publications were screened and 14 publications related to the topic were selected. The existing literature that examined patient selection for intervention in the outpatient setting, rates of complications after outpatient procedures, and short-term data on the safety and efficacy of these procedures is discussed. Gaps were identified in current knowledge about the long-term outcomes of peripheral arterial interventions performed in the office-based laboratory setting, as well as existing guidelines for the management of patients with peripheral arterial disease.

The office-based laboratory (OBL) industry has proliferated over the past decade as surgical cases have increasingly migrated from inpatient to outpatient surgical settings, including OBLs, ambulatory surgery centers and infusion centers. Although many physicians and patients prefer to provide and receive care in an OBL setting because it provides a high quality, lower cost and convenient alternative to receiving care in a hospital, the OBL industry is nonetheless under attack on a variety of fronts. Governmental and commercial payor reimbursement for OBL procedures has declined substantially over time, and there have been lawsuits, governmental investigations and news articles that have been critical of care provided in OBLs. These issues have generated headwinds for this young but growing industry. It is therefore important for physicians and investors alike interested in developing an OBL to be aware of the complex landscape of laws and regulations that apply to OBLs. This article provides an overview of key legal, corporate, tax, financial and structural considerations for operators to be aware of before opening an OBL.

OBJECTIVE: Controversy exists regarding the value and limitations of different sites of service for peripheral artery disease treatment. We aimed to examine practice patterns associated with peripheral vascular interventions (PVIs) performed in the office-based laboratory (OBL) vs outpatient hospital site of service using a nationally representative database.
METHODS: Using 100% Medicare fee-for-service claims data, we identified all patients undergoing PVI for claudication or chronic limb-threatening ischemia (CLTI) between January 2017 and December 2022. We evaluated the associations of patient and procedure characteristics with site of service using multivariable hierarchical logistic regression. We used multinomial regression models to estimate the relative risk ratios (RRRs) of site of service and intervention type (angioplasty, stent, or atherectomy) and intervention anatomic level (iliac, femoropopliteal, or tibial) after adjusting for baseline patient characteristics and clustering by physician.
RESULTS: Of 848,526 PVI, 485,942 (57.3%) were performed in an OBL. OBL use increased significantly over time from 48.3% in 2017 to 65.5% in 2022 (P < .001). Patients treated in OBLs were more likely to be Black (adjusted odds ratio [aOR], 1.14; 95% confidence interval [CI], 1.11-1.18) or other non-White race (aOR, 1.13; 95% CI, 1.08-1.18), have fewer comorbidities, and undergo treatment for claudication vs CLTI (aOR, 1.30; 95% CI, 1.26-1.33) compared with patients treated in outpatient hospital settings. Physicians with majority practice (>50% procedures) in an OBL were more likely to practice in urban settings (aOR, 21.58; 95% CI, 9.31-50.02), specialize in radiology (aOR, 18.15; 95% CI, 8.92- 36.92), and have high-volume PVI practices (aOR, 2.15; 95% CI, 2.10-2.29). The median time from diagnosis to treatment was shorter in OBLs, particularly for patients with CLTI (29 vs 39 days; P < .001). The OBL setting was the strongest predictor of patients receiving an atherectomy alone (adjusted RRR [aRRR] 6.67; 95% CI, 6.59-6.76) or atherectomy + stent (aRRR, 10.84; 95% CI, 10.64-11.05), and these findings were consistent in subgroup analyses stratified by PVI indication. The OBL setting was also associated with higher risk of tibial interventions for both claudication (aRRR, 3.18; 95% CI, 3.11-3.25) and CLTI (aRRR, 1.89; 95% CI, 1.86-1.92). The average reimbursement (including professional and facility fees) was slightly higher for OBLs compared with the hospital ($8742/case vs $8459/case; P < .001). However, in a simulated cohort resetting the OBL\'s intervention type distribution to that of the hospital, OBLs were associated with a hypothetical cost savings of $221,219,803 overall and $2602 per case.
CONCLUSIONS: The OBL site of service was associated with greater access to care for non-White patients and a shorter time from diagnosis to treatment, but more frequently performed high-cost interventions compared with the outpatient hospital setting. The benefit to patients from improved access to peripheral artery disease care in OBL settings must be balanced with the potential limitations of receiving differential care.

OBJECTIVE: The objective of this study was to investigate the administrative and clinical impacts of prior authorization (PA) processes in the office-based laboratory (OBL) setting.
METHODS: This single-institution, retrospective analysis studied all OBL PAs pursued between January 2018 and March 2022. Case, PA, and coding information was obtained from the practice\'s scheduling database.
RESULTS: Over the study period, 1854 OBL cases were scheduled; 8% (n = 146) required PA. Of these, 75% (n = 110) were for lower extremity arterial interventions, 19% (n = 27) were for deep venous interventions, and 6% (n = 9) were for other interventions. Of 146 PAs, 19% (n = 27) were initially denied but 74.1% (n = 7) of these were overturned on appeal. Deep venous procedures were initially denied, at 43.8% (n = 14), more often than were arterial procedures, at 11.8% (n = 13). Of 146 requested procedures, 4% (n = 6) were delayed due to pending PA determination by a mean 14.2 ± 18.3 working days. An additional 6% (n = 8) of procedures were performed in the interest of time before final determination. Of the seven terminally denied procedures, 57% (n = 4) were performed at cost to the practice based on clinical judgment.
CONCLUSIONS: Using PA appeals mechanisms, while administratively onerous, resulted in the overturning of most initial denials.

UNASSIGNED: Manual compression remains the gold standard for achieving hemostasis for percutaneous common femoral artery access. However, it requires prolonged bedrest and 20 to 30 minutes 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.
UNASSIGNED: 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.
UNASSIGNED: A total of 442 patients were enrolled with common femoral access only. Median age was 78 years (range, 48-91 years), 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 12.1 seconds (±13.2 seconds), time to ambulation was 17.1 minutes (±5.2 minutes), and time to discharge was 31.7 minutes (±8.9 minutes). 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.
UNASSIGNED: 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.

Despite societal guidelines that peripheral vascular intervention (PVI) should not be the first-line therapy for intermittent claudication, a significant number of patients will undergo PVI for claudication within 6 months of diagnosis. The aim of the present study was to investigate the association of early PVI for claudication with subsequent interventions.
We evaluated 100% of Medicare fee-for-service claims to identify all beneficiaries with a new diagnosis of claudication from January 1, 2015 to December 31, 2017. The primary outcome was late intervention, defined as any femoropopliteal PVI performed >6 months after the claudication diagnosis (through June 30, 2021). Kaplan-Meier curves were used to compare the cumulative incidence of late PVI for claudication patients with early (≤6 months) PVI vs those without early PVI. A hierarchical Cox proportional hazards model was used to evaluate the patient- and physician-level characteristics associated with late PVIs.
A total of 187,442 patients had a new diagnosis of claudication during the study period, of whom 6069 (3.2%) had undergone early PVI. After a median follow-up of 4.39 years (interquartile range, 3.62-5.17 years), 22.5% of the early PVI patients had undergone late PVI vs 3.6% of those without early PVI (P < .001). Patients treated by high use physicians of early PVI (≥2 standard deviations; physician outliers) were more likely to have received late PVI than were patients treated by standard use physician of early PVI (9.8% vs 3.9%; P < .001). Patients who had undergone early PVI (16.4% vs 7.8%) and patients treated by outlier physicians (9.7% vs 8.0%) were more likely to have developed CLTI (P < .001 for both). After adjustment, the patient factors associated with late PVI included receipt of early PVI (adjusted hazard ratio [aHR], 6.89; 95% confidence interval [CI], 6.42-7.40) and Black race (vs White; aHR, 1.19; 95% CI, 1.10-1.30). The only physician factor associated with late PVI was a majority of practice in an ambulatory surgery center or office-based laboratory, with an increasing proportion of ambulatory surgery center or office-based laboratory services associated with significantly increased rates of late PVI (quartile 4 vs quartile 1; aHR, 1.57; 95% CI, 1.41-1.75).
Early PVI after the diagnosis of claudication was associated with higher late PVI rates compared with early nonoperative management. High use physicians of early PVI for claudication performed more late PVIs than did their peers, especially those primarily delivering care in high reimbursement settings. The appropriateness of early PVI for claudication needs critical evaluation, as do the incentives surrounding the delivery of these interventions in ambulatory intervention suites.

Despite societal guidelines that peripheral vascular intervention (PVI) should not be the first-line therapy for intermittent claudication, a significant number of patients will undergo PVI for claudication within 6 months of diagnosis. The aim of the present study was to investigate the association of early PVI for claudication with subsequent interventions.
We evaluated 100% of Medicare fee-for-service claims to identify all beneficiaries with a new diagnosis of claudication from January 1, 2015 to December 31, 2017. The primary outcome was late intervention, defined as any femoropopliteal PVI performed >6 months after the claudication diagnosis (through June 30, 2021). Kaplan-Meier curves were used to compare the cumulative incidence of late PVI for claudication patients with early (≤6 months) PVI vs those without early PVI. A hierarchical Cox proportional hazards model was used to evaluate the patient- and physician-level characteristics associated with late PVIs.
A total of 187,442 patients had a new diagnosis of claudication during the study period, of whom 6069 (3.2%) had undergone early PVI. After a median follow-up of 4.39 years (interquartile range, 3.62-5.17 years), 22.5% of the early PVI patients had undergone late PVI vs 3.6% of those without early PVI (P < .001). Patients treated by high use physicians of early PVI (≥2 standard deviations; physician outliers) were more likely to have received late PVI than were patients treated by standard use physician of early PVI (9.8% vs 3.9%; P < .001). Patients who had undergone early PVI (16.4% vs 7.8%) and patients treated by outlier physicians (9.7% vs 8.0%) were more likely to have developed CLTI (P < .001 for both). After adjustment, the patient factors associated with late PVI included receipt of early PVI (adjusted hazard ratio [aHR], 6.89; 95% confidence interval [CI], 6.42-7.40) and Black race (vs White; aHR, 1.19; 95% CI, 1.10-1.30). The only physician factor associated with late PVI was a majority of practice in an ambulatory surgery center or office-based laboratory, with an increasing proportion of ambulatory surgery center or office-based laboratory services associated with significantly increased rates of late PVI (quartile 4 vs quartile 1; aHR, 1.57; 95% CI, 1.41-1.75).
Early PVI after the diagnosis of claudication was associated with higher late PVI rates compared with early nonoperative management. High use physicians of early PVI for claudication performed more late PVIs than did their peers, especially those primarily delivering care in high reimbursement settings. The appropriateness of early PVI for claudication needs critical evaluation, as do the incentives surrounding the delivery of these interventions in ambulatory intervention suites.

A recent shift in the location where peripheral endovascular interventions (PVI) are performed has occurred, from traditional settings such as hospital outpatient departments (HOPD), to ambulatory surgical centers (ASC) and outpatient-based laboratories (OBL). Different settings may influence the safety and efficacy of the PVI, as well as how it is done. This study aims to compare the postprocedural outcomes and intraprocedural details between the three settings.
The Vascular Quality Initiative database was queried for all elective infrainguinal PVIs for occlusive peripheral arterial disease between January 2016 and December 2021. The primary outcomes were rates of postprocedural hospital admissions, postprocedural medical complications, and access site complications. Secondary outcomes included technical success and intraprocedural details, such as types and number of devices used, amount of contrast, and fluoroscopy time. The χ2 test, analysis of variance, and multivariate logistic regression were used to analyze the outcomes.
A total of 66,101 PVI cases (HOPD, 57,062 [83.33%]; ASC, 4591 [6.95%]; OBL, 4448 [6.73%]) were included in the study. There were 445 cases requiring hospital admission (HOPD, 398 [0.70%]; ASC, 26 [0.57%]; OBL, 21 [0.47%]; P = .126). There were no significant differences in cardiac, pulmonary, or renal complications. Access site complications occurred in less than 1.7% of all cases and were significantly higher in OBLs when compared with ASCs (adjusted odds ratio [aOR], 3.70; 95% confidence interval [CI], 1.70-8.03; P = .001) and significantly lower in ASCs in comparison to HOPDs (aOR, 0.27; 95% CI, 0.18-0.41; P < .001). Technical success occurred in at least 92% of all cases, regardless of setting. There was a 16-fold increase in the use of atherectomy devices in an OBL vs HOPD setting (aOR, 16.79; 95% CI, 11.77-23.95; P < .001) and a five-fold increase in the use of atherectomy devices in an ASC vs HOPD setting (aOR, 5.37; 95% CI, 2.47-11.65; P < .001). There was a five-fold decrease in the use of special balloons in an OBL vs HOPD setting (aOR, 0.20; 95% CI, 0.10-0.39; P < .001) and a four-fold decrease when comparing ASCs with HOPDs (aOR, 0.25; 95% CI, 0.12-0.51; P < .001).
Elective PVIs performed in any outpatient setting proved to be safe and technically successful. However, there are significant differences in the way PVIs are performed in each setting, such as the greater use of atherectomy devices in OBLs and greater use of special balloons in HOPDs. Long-term studies are needed to evaluate the durability and reintervention outcomes and understand factors associated with practice pattern variability across these different settings.

BACKGROUND: Venous stenting for iliac vein outflow obstruction is associated with excellent long-term stent patency and symptom resolution. However, the safety of iliac vein stenting performed in an office-based laboratory (OBL) setting is not well-defined. The purpose of our investigation was to determine the safety profile of iliac vein stenting in an OBL setting.
METHODS: Data were prospectively collected in the Center for Vascular Medicine electronic medical record system (NextGen Healthcare Information System, Irvine, Calif) and retrospectively analyzed. Standardized patient safety and sedation protocols were used in accordance with the accreditation standards of the Joint Commission for Accreditation of Hospital Organizations for office-based surgery centers. Patient consultations, interventions, and follow-up at 1 to 6 weeks were included in the present analysis. All the patients had received moderate sedation during their procedure. Complications requiring hospitalization were classified as major complications. Minor complications consisted of bleeding, hematoma, vasovagal response, in-stent thrombosis resulting in complete occlusion of the iliac vein stent, an allergic reaction, hematemesis, hypotension, pelvic discomfort, and pseudoaneurysm.
RESULTS: Between January 2015 and January 2019, 1223 iliac vein stents were placed in 1104 patients (23.7% male; 76.3% female). A total of 90 minor complications (7.36%) and 5 major complications (0.41%) were observed. The major complications included the following: one allergic reaction, one episode of atrial fibrillation, one episode of supraventricular tachycardia, one episode of chest pain, and one case of acute stent occlusion. The minor complications were primarily insertion site hematomas. No complications were related to sedation or acute renal failure. No patient died.
CONCLUSIONS: Major complications were rare after iliac vein stenting in an OBL setting. Minor complications were primarily insertion site hematomas, which did not require inpatient hospitalization. Our analysis has shown that iliac vein stenting in an OBL setting is a safe and well-tolerated procedure.

Few data are available on the safety of interventions for peripheral arterial disease (PAD) performed in the office-based laboratory (OBL) setting. Thus, the aim of this study was to investigate the short- and late-term outcomes of patients treated in OBL vs hospital settings.
We included patients with PAD treated with any United States Food and Drug Administration approved or cleared devices for distal femoropopliteal and/or infrapopliteal disease. Data were retrieved from the LIBERTY 360 study. A propensity-scored, matched analysis was conducted and hazard ratios with the respective 95% confidence intervals were synthesized to examine the outcomes after interventions at OBL vs non-OBL settings.
A total of 710 propensity-scored patients (355 OBL patients and 355 non-OBL patients) with 907 treated lesions (454 OBL lesions and 453 non-OBL lesions), were included. For almost all subjects, balloon angioplasty was the preferred treatment approach (341 [96.1%] in the OBL group vs 353 [99.4%] in the non-OBL group; P<.01), with bail-out stenting necessary in 5.1% of the OBL group and 3.1% of the non-OBL group. Overall, significant angiographic complications occurred in 7.8% of all patients treated, with no differences between the 2 groups. The risk for all-cause death, target-vessel revascularization, and major amputation and death combined was similar between the 2 groups during 3-year follow-up.
Peripheral artery endovascular interventions in patients with chronic threatening ischemia or claudication, performed in the OBL setting, are safe and associated with favorable outcomes at 3 years of follow-up. These results demonstrate that treatment at OBLs is comparable to non-OBL settings. Further comparative studies and larger registries are needed to benchmark procedural quality and long-term outcomes.