Office-based Laboratories Research Articles

Vascular Care Delivery during the COVID-19 Pandemic: Impact of Office-Based Laboratory and Ambulatory Surgery Center

Objective: To evaluate how access to an office-based laboratory (OBL) and ambulatory surgery center (ASC) impacted vascular care during the Coronavirus Disease 2019 (COVID-19) pandemic. Methods: Vascular procedures performed by our group during the 6-week period before COVID-19 restrictions (group 1) and in the first 6-week period during the COVID-19 restrictions (group 2) were reviewed. The number of procedures performed was categorized as hospital inpatient (HIP), hospital outpatient (HOP), OBL, ASC, and vein center (VC). The procedures were also grouped by type: aneurysm (AAA), carotid (CAR), peripheral arterial disease (PAD), amputation/wound care (AMP), vascular access (VA), deep vein thrombosis (DVT), and venous reflux (CVI). The number of healthcare provider contact points for each patient undergoing care at the HOP, OBL, and ASC were also collected and compared between groups 1 and 2. Differences between groups were determined using the two-way ANOVA. Results: There were no statistically significant differences between groups 1 and 2 for procedure location or type of procedure (p > 0.05). Patient contact with healthcare providers decreased between groups 1 and 2 for ambulatory care. However, projecting the number of contacts for patients in group 2 if they had to have ambulatory care in the HOP setting (913) compared to contacts in the OBL and ASC setting (588) was statistically significant (p < 0.05). No patient or staff member at the OBL or ASC developed COVID-19 infection because of the care received at these venues. Conclusions: The ability to provide essential care for patients in an ambulatory environment was enhanced using our OBL and ASC without compromising safety, efficacy, or transmission of the virus to patients or staff during the height of the COVID-19 pandemic and limited their contact with healthcare workers and therefore reduced the consumption of personal protective equipment by healthcare personnel.

Practice patterns of peripheral vascular interventions for peripheral artery disease in the office-based laboratory setting versus outpatient hospital

ObjectiveControversy 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. MethodsUsing 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. ResultsOf 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. ConclusionsThe 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.

Comparison of outcomes of percutaneous deep venous arterialization in multiple practice settings

ObjectiveWe compared the efficacy of percutaneous deep venous arterialization (pDVA) in patients with no-option chronic limb-threatening ischemia in the hospital vs in office-based laboratory (OBL) settings. MethodsA retrospective chart review was performed of all patients who underwent pDVA using off-the-shelf devices from January 2018 to March 2023 in a hospital and an OBL. We identified 73 eligible patients, 41 from a hospital setting (59% male; median age, 72 years; interquartile range, 18 years) and 32 from an OBL setting (59% males; 67 years; interquartile range, 16 years). All eligible patients were deemed to have no-option critical limb ischemia, had at least one patent proximal tibial artery available for the creation of an arteriovenous anastomosis, and were classified as having Rutherford classification IV or higher peripheral arterial disease. Patients were ineligible if classified as Rutherford classification III or lower, had active infection, did not have at least one appropriate venous target, and/or had rapidly progressing wounds requiring immediate major amputation. The primary outcome was major amputation-free survival (AFS). Secondary outcomes included technical success, limb salvage, survival, primary patency, reintervention rate, adverse events, and partial and complete wound healing. Outcomes were evaluated using Kaplan-Meier method, log-rank, and two-stage procedure tests. ResultsTechnical success was achieved in 70 patients (96%) with 1 hospital (2.4%) and 2 OBL (6.3%) patients lost to follow-up. Major AFS estimates at 6 months, 1 year, and 2 years were 51.4%, 40.4%, and 30.2% in the hospital group and 69.4%, 54.0%, and 49.5% in the OBL group, respectively. Partial wound healing estimates at 6 months, 1 year, and 2 years were 27.5%, 71.7%, and 81.2% in the hospital group and 62.7% at all time points in the OBL group. Complete wound healing estimates at 6 months, 1 year, and 2 years were 6.7%, 33.3%, and 33.3% in the hospital group and 5.3%, 37.7%, and 41.6% in the OBL group, respectively. There was no significant difference in major AFS (P = .13), limb salvage (P = .07), survival (P = .69), primary patency (P = .53), partial (P = .08), or complete wound healing (P = .79) between groups. Reintervention was performed in 8 hospital (20.5%) and 14 OBL (45.2%) patients. ConclusionspDVA is a feasible and safe procedure for no-option critical limb ischemia in the hospital and OBL setting without significant differences in outcomes at ≤2 years.

Practice patterns in utilization of atherectomy and embolic protection devices in inpatient and outpatient treatment settings

ObjectiveThe frequency of atherectomy in lower extremity arterial disease has increased substantially over the past several years, specifically in the office-based laboratory (OBL) setting, yet the efficacy compared with other interventions and the consequences of distal embolization remain unknown. Embolic protection devices (EPDs) have been used at varying rates depending on physician and practice setting. Previous studies have described lesion characteristics to consider when weighing the benefits and drawbacks associated with device use. Our study focuses on the use of atherectomy and EPDs in femoropopliteal arterial disease to better characterize resource use trends and postoperative outcomes in the inpatient and OBL interventional settings. MethodsWe conducted a retrospective analysis on endovascular interventions performed for femoral-popliteal occlusive disease that were entered into the Vascular Quality Initiative data registry between 2017 and 2021. A one:one greedy match, adjusted analysis based on inpatient or OBL location of procedure was used to compare the groups. Hierarchical logistical regression with selective use of principal component analysis was used to further explore the differences in EPD use and immediate postoperative outcomes. A proportional hazard model was used to demonstrate differences in reintervention rates up to 2 years postoperatively between patients who underwent atherectomy in the inpatient vs OBL treatment setting. Results2849 matched pairs were inlcuded in the final analysis. In our cohort, there was 22% EPD use overall, 40% in the hospital setting and 4.4% in the OBL setting (P < .001). Among the patients with available follow-up information, OBL intervention setting increased probability of reintervention by 18% at 2 years postoperatively compared with the inpatient setting; however, there was no difference associated with EPD placement and rate of reintervention. ConclusionsUse of EPDs in the OBL setting compared with the hospital setting is dramatically decreased; however, no increased incidence of postoperative complications was seen compared to procedures performed in the hospital setting when controlling for patient and lesion characteristics. Patients with available follow-up data were more likely to undergo ipsilateral reintervention between 6 months and 2 years postoperatively if atherectomy was done in the OBL setting. Dedicated studies are encouraged to ensure patient safety, effective resource allocation, and long-term efficacy of OBL atherectomy as an ever-growing number of peripheral arterial procedures are transitioned to the OBL setting.

Medicare Patients With Peripheral Artery Disease Are Treated More Quickly but Undergo Higher Cost Interventions in Office-Based Laboratories vs Outpatient Hospital Settings

Medicare Patients With Peripheral Artery Disease Are Treated More Quickly but Undergo Higher Cost Interventions in Office-Based Laboratories vs Outpatient Hospital Settings

Atherectomy – The Options, the Evidence, and When Should It Be Used

The use of atherectomy for peripheral vascular interventions (PVI) has increased exponentially and reached 18% of all PVI in the United States. The theoretical benefit on extensive arterial calcification relies on the concept of plaque modification and removal instead of displacement, as with other endovascular techniques. To date, there are no prospective studies comparing the different atherectomy technologies (directional, rotational, orbital, and laser). Moreover, most related prospective comparative studies have a small number of patients, and larger studies are single arm in patients with relatively mild to moderate disease burden. While available literature shows lower dissection risk and reduced bailout stenting, the superiority of this technology compared to other endovascular techniques has yet to be proven. Despite the lack of level 1 evidence to support its superiority, the lucrative reimbursement fueled the overuse of this technology as first-line therapy, particularly in office-based laboratories and ambulatory surgery centers. The use of atherectomy ought to be selective and complementary to other endovascular technologies, and individualized patient-level decision-making based on the practitioner’s preference and expertise is essential to selectively incorporate atherectomy in managing complex atherosclerotic lesions.

Developing an OBL: Key Considerations Before Spending a Dime Or Too Much Time

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.

Interventional radiologists and OBLs: An excellent match

While office-based laboratories (OBLs) have been increasing in popularity, only a small proportion of the current interventional radiology (IR) workforce works in an OBL. With the relative lack of an IR presence in OBLs compared to other endovascular specialists, combined with the growth of the OBL space, the presence of IR within OBLs will likely increase in the coming years. This article addresses the value interventional radiologists (IRs) can bring to the OBL, with primary impacts being the ability to impact a larger proportion of the population than is traditionally cared for in most hospital settings, the ability to positively influence multidisciplinary care teams and the financial leverage inherent in procedural diversification not readily afforded by other specialists working in the OBL space. IR-specific pitfalls in the OBL space are also addressed, including difficulties in obtaining patient referrals, investor relationships, and group practice arrangements. Despite potential challenges, IRs have a lot to offer within the OBL space, and conversely, the OBL space provides a mechanism for IRs to increase their reach and improve career longevity.

Running a quality-focused office-based laboratory

Running a quality-focused office-based laboratory

Prior authorization requirements in the office-based laboratory setting are administratively inefficient and threaten timeliness of care

ObjectiveThe objective of this study was to investigate the administrative and clinical impacts of prior authorization (PA) processes in the office-based laboratory (OBL) setting. MethodsThis 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. ResultsOver 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. ConclusionsUsing PA appeals mechanisms, while administratively onerous, resulted in the overturning of most initial denials.

Percutaneous Deep Venous Arterialization in Patients with No-Option Critical Limb Ischemia Performed in an Office-Based Laboratory Setting

PurposeTo evaluate the feasibility and safety of percutaneous deep venous arterialization (pDVA) performed in an office-based laboratory (OBL) for patients with no-option critical limb ischemia (CLI). Materials and MethodsA retrospective chart review was performed of all patients who underwent pDVA using commercially available devices from January 2018 to November 2021 in a single OBL. In total, 22 patients (10 males and 12 females; Rutherford 4, 5, and 6: n = 1, 8, and 13, respectively) were identified with a median follow-up of 140 days. Amputation-free survival, wound healing, pDVA patency, and overall survival were evaluated at 30 days, 6 months, and throughout the remaining follow-up period. ResultsAll patients had undergone failed previous attempts at endovascular arterial reconstruction. At 6 months after procedure, 6.4% of arteriovenous conduits remained patent; 83.3% (10/12) of patients experienced complete or partial wound healing. In addition, 78.6% of patients avoided an above-ankle amputation, and overall survival was 83.6%. Nine patients underwent endovascular reinterventions at 6 months. One mild adverse event and 4 moderate adverse events occurred after procedure, and 1 cardiac death occurred 5 days after procedure. ConclusionspDVA is safe and feasible in the OBL for patients with no-option CLI. Many patients avoided an above-ankle amputation during the study period despite low overall pDVA patency.

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.

Reprint of: Early peripheral vascular interventions for claudication are associated with higher rates of late interventions and progression to chronic limb threatening ischemia

ObjectiveDespite 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. MethodsWe 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. ResultsA 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). ConclusionsEarly 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.

Trends and outcomes associated with intravascular ultrasound use during femoropopliteal revascularization in the Vascular Quality Initiative

ObjectiveIntravascular ultrasound (IVUS) use in lower extremity interventions is growing in popularity owing to its imaging in the axial plane, superior detail in imaging lesion characteristics, and its enhanced ability to delineate lesion severity and extent compared with catheter angiograms. However, there are conflicting data regarding whether IVUS affects outcomes. The purpose of this study was to assess the effect associated with IVUS implementation in femoropopliteal interventions. MethodsThis retrospective cohort study used Vascular Quality Initiative data. Patients undergoing an index endovascular femoropopliteal revascularization from 2016 to 2021 were included. Patients were differentiated by whether or not IVUS was used to assess the femoropopliteal segment during intervention (no IVUS, IVUS). Propensity score matching, based on preoperative demographics and measures of disease severity was used. Primary outcomes were major amputation-free survival (AFS), femoropopliteal reintervention-free survival (RFS), and primarily patent survival (PPS) at 12 months. ResultsIVUS use grew steadily throughout the study period, comprising 0.6% of interventions in 2016 and increasing to 8.2% of interventions by 2021; growth was most dramatic in ambulatory surgical center or office-based laboratory settings where IVUS use grew from 4.4% to 43% to 47% of interventions. In unmatched cohorts, patients receiving interventions using IVUS tended to have lower prevalence of multiple cardiovascular comorbidities (eg, congestive heart failure, hypertension, diabetes, and dialysis dependence) and presented more often with claudication and less often with chronic limb-threatening ischemia (CLTI). Intraoperatively, IVUS was used more often in complex femoropopliteal lesions (Transatlantic Intersociety grade D vs A), and more often in conjunction with stenting and/or atherectomy. IVUS use was associated with improved AFS, but similar RFS and PPS at 12 months. However, in multivariable analysis IVUS was not associated with any of the primary outcomes independently; rather, all outcomes were influenced primarily by CLTI, dialysis dependence, and prior major amputation status; technical outcomes (ie, RFS and PPS loss) were further driven by complexity of lesion (worse in Transatlantic Intersociety grade D vs A lesions) and treatment setting (ie, ambulatory surgical center or office-based laboratory setting associated with increased hazard for RFS and PPS loss). ConclusionsIVUS implementation in femoropopliteal interventions is growing, with rapid adoption among interventions in ambulatory surgical centers and office-based laboratories. IVUS was not associated with an effect on technical outcomes at 12 months; improvement in major AFS was observed; however, multivariable analysis suggests this finding may be an effect of confounding by multiple factors highly associated with IVUS use, namely, in patients with lower prevalence of CLTI, dialysis dependence, and prior major amputations, thus conveying baseline lower risk for major amputation and death.

Utilizing an office based laboratory (OBL) during the COVID-19 pandemic for vascular surgical patients

COVID-19 pandemic brought new challenges in healthcare including the need to create tiered class recommendations about which types patients to treat urgently and which surgical cases to defer. This is a report of a single center's Office Based Laboratory (OBL) system to prioritize vascular patients and preserve acute care resources and personnel. In reviewing three months of data, it appears that by continuing to provide the urgent care needed for this chronically ill population, the insurmountable backup of surgical procedures is prevented in the operating room once elective surgeries resumed. The OBL was able to continue providing care at the same pre-pandemic rate to a large intercity population.

Early peripheral vascular interventions for claudication are associated with higher rates of late interventions and progression to chronic limb threatening ischemia

ObjectiveDespite 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. MethodsWe 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. ResultsA 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). ConclusionsEarly 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.

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.

Practice patterns surrounding the use of tibial interventions for claudication in the Medicare population

ObjectiveAt present, no data are available to support the use of tibial interventions in the treatment of claudication. We characterized the practice patterns surrounding tibial peripheral vascular interventions (PVIs) for patients with claudication in the United States. MethodsUsing 100% Medicare fee-for-service claims from 2017 to 2019, we conducted a retrospective analysis of all patients who underwent an index PVI for claudication. Patients with any previous PVI, acute limb ischemia, or chronic limb-threatening ischemia in the preceding 12 months were excluded. The primary outcome was the receipt or delivery of tibial revascularization during an index PVI for claudication, defined as tibial PVI with or without concomitant femoropopliteal PVI. Univariable comparisons and multivariable hierarchical logistic regression were used to assess the patient and physician characteristics associated with the use of tibial PVI for claudication. ResultsOf 59,930 Medicare patients who underwent an index PVI for claudication between 2017 and 2019, 16,594 (27.7%) underwent a tibial PVI (isolated tibial PVI, 38.5%; tibial PVI with concomitant femoropopliteal PVI, 61.5%). Of the 1542 physicians included in our analysis, the median physician-level tibial PVI rate was 20.0% (interquartile range, 9.1%-37.5%). Hierarchical logistic regression suggested that patient-level characteristics associated with tibial PVI for claudication included male sex (adjusted odds ratio [aOR], 1.23), increasing age (aOR, 1.30-1.96), Black race (aOR, 1.47), Hispanic ethnicity (aOR, 1.86), diabetes (aOR, 1.36), no history of hypertension (aOR, 1.12), and never-smoking status (aOR, 1.64; P < .05 for all). Physician-level characteristics associated with tibial PVI for claudication included early-career status (aOR, 2.97), practice location in the West (aOR, 1.75), high-volume PVI practice (aOR, 1.87), majority of practice in an ambulatory surgery center or office-based laboratory setting (aOR, 2.37), and physician specialty. The odds of vascular surgeons performing tibial PVI were significantly lower compared with radiologists (aOR, 2.98) and cardiologists (aOR, 1.67; P < .05 for all). The average Medicare reimbursement per patient was dramatically higher for physicians performing high rates of tibial PVI (quartile 4 vs quartile 1-3, $12,023.96 vs $692.31 per patient; P < .001). ConclusionsTibial PVI for claudication was performed more often by nonvascular surgeons in high-volume practices and high-reimbursement settings. Thus, a critical need exists to reevaluate the indications, education, and reimbursement policies surrounding these procedures.

Atherectomy overuse is a real problem

Atherectomy overuse is a real problem