The Sustained Impact of the COVID-19 Pandemic on Vascular Surgical Care Delivery.

OBJECTIVE: The COVID-19 pandemic necessitated postponement of vascular surgery procedures nationally. Whether procedure volumes have since recovered remains undefined. Therefore, our objective was to quantify changes in procedure volumes and determine whether surgical volume has returned to its pre-pandemic baseline. METHODS: This study was a retrospective cross-sectional study between 2018 and 2023 utilizing the US Fee-for-Service Medicare 5% National Sample as part of the VA Disrupted Care National Project. We studied patients who underwent one of three procedures: abdominal aortic aneurysm (AAA) repair for intact aneurysms, carotid endarterectomy (CEA), and major lower extremity amputation (LEA). The case volume of each quarter of 2020-2023 was compared to its corresponding pre-pandemic quarter in 2019. We then performed a sub-analysis of these trends by sex, age, and race. RESULTS: We identified 21,031 procedures: 4,411 AAA repair, 8,361 CEA, and 8,259 LEA. The average percent change during the baseline pre-pandemic period from 2018 to 2019 was -4.3% for AAA repair, -8.5% for CEA, and -2.6% for LEA. Compared to Q2 of 2019, Q2 of 2020 demonstrated that AAA repair procedures decreased by 47%, CEA by 40%, and LEA by 14%. While procedures initially rebounded in Q3 of 2020, volumes did not return to their pre-pandemic baseline, demonstrating a persistent volume reduction (-16% AAA, -22% CEA, and -11% LEA). Thereafter, procedure counts again declined in Q1 of 2022 (-25% AAA, -34% CEA, and -25% LEA). CONCLUSIONS: Despite a perception that vascular surgical care was singularly disrupted at the outset of the pandemic, there has been a sustained reduction in vascular surgical volume since 2019. Not only have procedure volumes not returned to pre-pandemic baseline, but it also appears that there has been a cumulative incremental impact on overall procedure volume. The impact of these findings on long term population health remain uncertain and necessitate a better understanding of post-pandemic care delivery.

Inter-Rater Reliability for the Amputation Endpoint in the National Vascular Quality Initiative.

BACKGROUND: National quality reporting efforts after revascularization for peripheral artery disease (PAD) are ongoing. Validation of endpoints are necessary in national quality registries. OBJECTIVES: This study sought to examine the interrater reliability for the endpoint of major amputation at 1 year in the Vascular Quality Initiative (VQI) registry and the Medicare-linked Vascular Quality Initiative registry (VQI-VISION) against electronic health record (EHR) review. METHODS: Surgical or endovascular revascularization procedures between January 1, 2010, and December 31, 2017, in the VQI registry and VQI-VISION for 2 academic health systems were queried. Major amputation data were abstracted by trained data collectors for the VQI and derived from Current Procedural Terminology codes for VQI-VISION. Cases underwent protocolized adjudication for the endpoint of major amputation by EHR review. Paired tests were used to evaluate the sensitivity and specificity. Spearman's ρ and Cohen's κ were used to evaluate interrater reliability. RESULTS: Amputation endpoints for 1,936 revascularizations were examined. Compared with major amputation data in EHR review, the sensitivity for the VQI registry was 35.9% and the specificity was 99.4% (ρ = 0.53; κ = 0.48). For VQI-VISION, sensitivity was 67.7% and specificity was 98.9% (ρ = 0.75; κ = 0.74). For any amputation in VQI data, sensitivity was 35.3% and specificity was 99.3% (ρ = 0.53; κ = 0.46), and for VQI-VISION, they were 71.6% and 97.7%, respectively (ρ = 0.75; κ = 0.74). CONCLUSIONS: Almost two-thirds of the amputations in the VQI registry and one-third of amputations in VQI-VISION were missing at 1 year compared against adjudicated EHR review. In preparing for national reporting systems for major amputation tracking, data collection system reform is needed.

A Retrospective Analysis of Surgical Acuity & Procedure Volume Before & During the COVID-19 Pandemic.

INTRODUCTION: In March 2020, the American College of Surgeons recommended postponing elective procedures amid the COVID-19 pandemic. We used Medicare claims to analyze changes in surgical and interventional procedure volumes from 2016 to 2021. METHODS: We studied 37 common surgical and interventional procedures using 5% Medicare claims files from January 1, 2016, through December 31, 2021. Procedures were classified according to American College of Surgeons guidelines as low, intermediate, or high acuity, and counts were analyzed per calendar year quarter (Q1-Q4), with stratification by sex and race/ethnicity. RESULTS: We observed 1,840,577 procedures and identified two periods of marked decline. In Q2 2020, overall procedure counts decreased by 32.2%, with larger declines in low (41.1%) and intermediate (30.8%) acuity procedures. High acuity procedures declined the least (18.2%). Overall volumes increased afterward but never returned to baseline. Another marked decline occurred in Q4 2021, with all acuity levels having declined to a similar extent (40.1%, 44.2%, and 46.9% for low, intermediate, and high acuity, respectively). High and intermediate acuity procedures declined more in Q4 2021 than Q2 2020 (P = 0.002). Similar patterns were observed across sex and race/ethnicity strata. CONCLUSIONS: Two major procedural volume declines occurred between 2020 and 2022 during the COVID-19 pandemic in the United States. High acuity (life or limb threatening) procedures were least affected in the first decline (Q2 2020) but not spared in second decline (Q4 2021). Future efforts should prioritize preserving high-acuity access during times of stress.

The Laparoscopy in Biliary Exploration Research and Training Initiative (LIBERTI) trial: simulator-based training for laparoscopic management of choledocholithiasis.

BACKGROUND: Laparoscopic cholecystectomy with common bile duct exploration (LCBDE) is equivalent in safety and efficacy to endoscopic retrograde cholangiopancreatography (ERCP) plus laparoscopic cholecystectomy (LC) while decreasing number of procedures and length of stay (LOS). Despite these advantages LCBDE is infrequently utilized. We hypothesized that formal, simulation-based training in LCBDE would result in increased utilization and improve patient outcomes across participating institutions. METHODS: Data was obtained from an on-going multi-center study in which simulator-based transcystic LCBDE training curricula were instituted for attending surgeons and residents. A 2-year retrospective review of LCBDE utilization prior to LCBDE training was compared to utilization up to 2 years after initiation of training. Patient outcomes were analyzed between LCBDE strategy and ERCP strategy groups using χ2, t tests, and Wilcoxon rank tests. RESULTS: A total of 50 attendings and 70 residents trained in LCBDE since November 2020. Initial LCBDE utilization rate ranged from 0.74 to 4.5%, and increased among all institutions after training, ranging from 9.3 to 41.4% of cases. There were 393 choledocholithiasis patients analyzed using LCBDE (N = 129) and ERCP (N = 264) strategies. The LCBDE group had shorter median LOS (3 days vs. 4 days, p < 0.0001). No significant differences in readmission rates between LCBDE and ERCP groups (4.7% vs. 7.2%, p = 0.33), or in post-procedure pancreatitis (0.8% v 0.8%, p > 0.98). In comparison to LCBDE, the ERCP group had higher rates of bile duct injury (0% v 3.8%, p = 0.034) and fluid collections requiring intervention (0.8% v 6.8%, p < 0.009) secondary to cholecystectomy complications. Laparoscopic antegrade balloon sphincteroplasty had the highest technical success rate (87%), followed by choledochoscopic techniques (64%). CONCLUSION: Simulator-based training in LCBDE results in higher utilization rates, shorter LOS, and comparable safety to ERCP plus cholecystectomy. Therefore, implementation of LCBDE training is strongly recommended to optimize healthcare utilization and management of patients with choledocholithiasis.

Trends of Concomitant Diabetes and Peripheral Artery Disease and Lower Extremity Amputation in US Medicare Patients, 2007 to 2019.

BACKGROUND: Previous studies demonstrate geographic and racial/ethnic variation in diagnosis and complications of diabetes and peripheral artery disease (PAD). However, recent trends for patients diagnosed with both PAD and diabetes are lacking. We assessed the period prevalence of concurrent diabetes and PAD across the United States from 2007 to 2019 and regional and racial/ethnic variation in amputations among Medicare patients. METHODS: Using Medicare claims from 2007 to 2019, we identified patients with both diabetes and PAD. We calculated period prevalence of concomitant diabetes and PAD and incident cases of diabetes and PAD for every year. Patients were followed to identify amputations, and results were stratified by race/ethnicity and hospital referral region. RESULTS: 9 410 785 patients with diabetes and PAD were identified (mean age, 72.8 [SD, 10.94] years; 58.6% women, 74.7% White, 13.2% Black, 7.3% Hispanic, 2.8% Asian/API, and 0.6% Native American). Period prevalence of diabetes and PAD was 23 per 1000 beneficiaries. We observed a 33% relative decrease in annual new diagnoses throughout the study. All racial/ethnic groups experienced a similar decline in new diagnoses. Black and Hispanic patients had on average a 50% greater rate of disease compared with White patients. One- and 5-year amputation rates remained stable at ≈1.5% and 3%, respectively. Native American, Black, and Hispanic patients were at greater risk of amputation compared with White patients at 1- and 5-year time points (5-year rate ratio range, 1.22-3.17). Across US regions, we observed differential amputation rates, with an inverse relationship between the prevalence of concomitant diabetes and PAD and overall amputation rates. CONCLUSIONS: Significant regional and racial/ethnic variation exists in the incidence of concomitant diabetes and PAD among Medicare patients. Black patients in areas with the lowest rates of PAD and diabetes are at disproportionally higher risk for amputation. Furthermore, areas with higher prevalence of PAD and diabetes have the lowest rates of amputation.

Deriving International Classification of Diseases, 9th and 10th revision, codes for identifying and following up patients with diabetic lower extremity ulcers.

Objective: Administrative claims data offer a rich data source for clinical research. However, its application to the study of diabetic lower extremity ulceration is lacking. Our objective was to create a widely applicable framework by which investigators might derive and refine the International Classification of Diseases, 9th and 10th revision (ICD-9 and ICD-10, respectively) codes for use in identifying diabetic, lower extremity ulceration. Methods: We created a seven-step process to derive and refine the ICD-9 and ICD-10 coding lists to identify diabetic lower extremity ulcers. This process begins by defining the research question and the initial identification of a list of ICD-9 and ICD-10 codes to define the exposures or outcomes of interest. These codes are then applied to claims data, and the rates of clinical events are examined for consistency with prior research and changes across the ICD-9 to ICD-10 transition. The ICD-9 and ICD-10 codes are then cross referenced with each other to further refine the lists. Results: Using this method, we started with 8 ICD-9 and 43 ICD-10 codes used to identify lower extremity ulcers in patients with known diabetes and peripheral arterial disease and examined the association of ulceration with lower extremity amputation. After refinement, we had 45 ICD-9 codes and 304 ICD-10 codes. We then grouped the codes into eight clinical exposure groups and examined the rates of amputation as a rudimentary test of validity. We found that the rate of lower extremity amputation correlated with the severity of lower extremity ulceration. Conclusions: We identified 45 ICD-9 and 304 ICD-10 ulcer codes, which identified patients at risk of amputation from diabetes and peripheral artery disease. Although further validation at the medical record level is required, these codes can be used for claims-based risk stratification for long-term outcomes assessment in the treatment of patients at risk of limb loss.

Survival, reintervention and surveillance reports: long-term, centre-level evaluation and feedback of vascular interventions.

The combination of registry and administrative claims data have facilitated research and quality improvement efforts. Using Vascular Quality Initiative (VQI) registry data and Medicare claims we have generated centre-specific survival, reintervention and surveillance reports which benchmark participating centres' performance to the VQI as a whole and to published guidelines. In 2021, we distributed these reports to 303 participating centres. These reports offer an opportunity for centres to evaluate their performance and identify focus areas for quality improvement work.

Alterations in tibiotalar joint reaction force following syndesmotic injury are restored with static syndesmotic fixation.

INTRODUCTION: Syndesmotic injury alters joint mechanics, which may fail to be restored unless an anatomic reduction is obtained. METHODS: A minimally invasive method of measuring joint forces was utilized that does not require significant dissection or intraarticular placement of sensory instruments. Steinmann pins were placed in the tibia and talus of eight fresh-frozen human cadaveric lower extremities and a baseline joint reaction force was determined. A syndesmotic injury was created and reduction (anatomic and anterior malreduction) performed with one or two quadricortical screws and joint reaction forces were measured after the injury and subsequent repairs. FINDINGS: Baseline mean tibiotalar joint reaction force was 31.4 (SD 7.3 N) and syndesmotic injury resulted in a 35% decrease (mean 20.3, SD 8.4 N, p < 0.01). Fixation of the injury using one or two syndesmotic screws resulted in significant increase compared to the injury state (mean 28.7, SD3.9 N, and mean 28.3, SD 6.4 N, p < 0.05), however there was no significant difference between the two methods of fixation. Malreduction of the fibula also increased joint reaction force compared to the injury state (mean 31.5, SD 5.2 N, p < 0.01), however a significant difference was not detected between malreduction and anatomic reduction. INTERPRETATION: The present study demonstrates that syndesmotic injury decreases joint reaction force within the tibiotalar joint, suggesting ankle joint instability. Tibiotalar force was restored with anatomic reduction with either a 1 or 2 quadricortical syndesmotic screws. Furthermore, anterior malreduction restored joint reaction force to levels similar to those observed at baseline and with anatomic reduction. LEVEL OF EVIDENCE: Level V: biomechanical/cadaver study.

Spring ligament tear decreases static stability of the ankle joint.

BACKGROUND: Spring ligament tear is often found in advanced adult acquired flatfoot deformity and its reconstruction in conjunction with the deltoid ligament has been proposed to restore the tibiotalar and talonavicular joint stability. The aim of the present study is to determine the effect of spring ligament injury and subsequent reconstruction on static joint reactive force using a non-invasive method of measurement. METHODS: Ten fresh-frozen human cadaveric lower legs were disarticulated at the knee joint. Static joint reactive force of the tibiotalar and talonavicular joint were measured at baseline, after spring ligament injury, and after ligament reconstruction. Reconstruction consisted of a forked semitendinosis allograft with dual limbs to reconstruct the tibionavicular and tibiocalcaneal ligaments. FINDINGS: The mean baseline joint reactive force of the tibiotalar and talonavicular joints were 37.2 N + 8.1 N and 13.4 N + 4.2 N, respectively. The spring ligament injury model resulted in a significant 29% decrease in tibiotalar joint reactive force. Reconstruction of the tibionavicular limb resulted in a significant increase in tibiotalar and talonavicular joint reactive force compared to those seen in the injury state. Furthermore, the addition of the tibiocalcaneal limb significantly increased tibiotalar joint reactive force compared to those results obtained from the injury state and the tibionavicular limb alone. INTERPRETATION: This is the first study to demonstrate diminished tibiotalar static joint reactive force in a spring ligament injury model with subsequent joint reactive force restoration using two-limbed reconstruction of the deltoid and spring ligament. LEVEL OF EVIDENCE: Biomechanical Study.

Operative Anatomy of the Medial Gastrocnemius Recession vs the Proximal Medial Gastrocnemius Recession.

BACKGROUND: Isolated gastrocnemius contracture (IGC) is associated with various foot and ankle pathologies. To address the problem of IGC, a number of gastrocnemius lengthening procedures have been described. Although proximal medial gastrocnemius recession (PMGR) has shown to be an effective operative treatment for IGC, it poses risks to various anatomic structures around the knee joint and requires the patient to be positioned prone. As an alternative, we proposed to release the medial gastrocnemius at the division between the proximal one-third and distal two-thirds of the gastrocnemius muscle to correct equinus contracture, while minimizing risk to other structures. The aim of this study was to describe an anatomic basis for a medial gastrocnemius recession (MGR) and to investigate the anatomic structures at risk in comparison to PMGR. METHODS: Eight cadaveric lower leg specimens were used in the study. The standard PMGR and the novel MGR were performed on each specimen. After completion of the 2 procedures, complete dissection was performed to investigate the distances between surgically released fascia margins and surrounding anatomic structures, including the greater saphenous vein, small saphenous vein, saphenous nerve, medial sural cutaneous nerve, semimembranosus tendon, tibial nerve, and popliteal artery. The mean distances were calculated and the shortest distances for each structure were reported. RESULTS: Proximities of anatomic structures to surgically released gastrocnemius fascia at the medial and lateral margins were notably different between the 2 techniques. For the PMGR, the semimembranosus tendon (95% confidence interval of 2.4-7.4 mm), small saphenous vein (3.4-10.0 mm), popliteal artery (3.9-9.3 mm), and tibial nerve (5.0-11.1 mm) were in greater proximity to the operative margin. For the MGR, the greater saphenous vein (5.3-17.6 mm) and saphenous nerve (5.1-18.6 mm) were at greater risk. CONCLUSIONS: MGR at the proximal one-third of the gastrocnemius muscle may be a safe alternative for operative treatment of IGC. CLINICAL RELEVANCE: We identified the major structures at risk when performing the proximal medial gastrocnemius release and propose a novel, possibly safer alternative for the medial gastrocnemius release.

Progesterone and low-dose vitamin D hormone treatment enhances sparing of memory following traumatic brain injury.

Progesterone (PROG) has been shown to protect the brain from traumatic injury and is now in Phase III clinical trials. Our work shows that PROG's beneficial effects can be reduced in vitamin D hormone (VDH)-deficient subjects. VDH can modulate neuronal apoptosis, trophic factors, inflammation, oxidative stress, excitotoxicity, and myelin and axon repair. We investigated whether VDH combined with PROG could improve behavioral outcomes more than PROG alone in VDH-sufficient rats given bilateral contusions of the medial frontal cortex. PROG and different doses of VDH (1 µg/kg, VDH1; 2.5 µg/kg, VDH2; 5 µg/kg, VDH3) were injected intraperitoneally 1 h post-injury. Eight additional doses of PROG were given subcutaneously over 8 days with tapering over the last 2 days. Neurobehavioral tests, necrotic cavity, neuronal death and activation of astrocytes were evaluated 21 days post-injury. We found that PROG and PROG + VDH preserve spatial memory processing. VDH1 + PROG improved performance in acquisition more effectively than PROG alone, indicating that the low VDH dose is optimal for combination therapy. There were no significant differences in necrotic cavity size among the groups. The density of positive staining for reactive astrocytes (glial fibrillary acidic protein (GFAP)) increased and the cell bodies and processes of GFAP-positive cells were enlarged in the PROG + VDH1 group. Our data indicate that the combination of PROG and VDH is more effective than PROG alone in preserving spatial and reference memory, and that PROG plus low-dose VDH can activateGFAP reactions up to 21 days after injury. This effect may be one of the mechanisms underlying PROG's neuroprotective effects in combination with VDH.