Jury verdicts, outcomes, and tort reform features of malpractice cases involving thoracic outlet syndrome.

OBJECTIVE/BACKGROUND: Thoracic outlet syndrome (TOS) is most often referred to vascular surgeons. However, there is a lack of understanding of the malpractice cases involving TOS. The goal of this study is to better understand the medicolegal landscape related to the care of TOS. METHODS: The Westlaw Edge AI-powered proprietary system was retrospectively reviewed for malpractice cases involving TOS. A Boolean search strategy was used to identify target cases under the case category of "Jury Verdicts & Settlements" for all state and federal jurisdictions from 1970 to September 2020. The settled case was described but not included in the statistical analysis. Descriptive statistics were used to report our findings, and when appropriate. The P ≤ .05 decision rule was established a priori as the null hypothesis rejection criterion to determine associations between jury verdicts outcomes and state's tort reform status. RESULTS: In this study, 39 cases were identified and met the study's inclusion criteria from the entire Westlaw Edge database. Among plaintiffs who disclosed age and/or gender, median age was 35.0 years with a female majority (67.6%). Cases involving TOS were noted to be steadily decreasing since the mid-1990s. The cases were unevenly spread across 18 states, with the highest number of cases (14, 35.9%) from California and the second highest (4, 10.3%) from Pennsylvania. A similar uneven distribution was seen among U.S. census regions, in which the West had the highest cases (39.5%). The study revealed that more cases were brought to trials in tort reform states (26, 68.4%) than in non-tort reform states (12, 31.6%). A total of 24 of 39 (61.5%) plaintiffs had one specific claim, which resulted in their economic and noneconomic damages. Negligent operation and treatment complication represented an overwhelming majority of claims brought by 38 of 39 plaintiffs (97.4%). Misdiagnosis and lack of informed consent were both brought nine times (23.1%) by the group. Intraoperative nerve injury (20 patients, 51.3%) was the most commonly reported complication. Excluding one case with a settlement of $965,000, 30 of 38 (78.9%) cases went to trials and received defense verdicts. Eight cases (20.5%) were found in favor of plaintiffs with a median payout of $725,581. CONCLUSIONS: This study highlighted higher than average payouts to plaintiffs and risk factors that may result in malpractice lawsuits for surgeons undertaking TOS treatment. Future studies are needed to further clarify the relationships between tort reform and outcomes of malpractice cases involving TOS.

Vascular surgery-related violations of the Emergency Medical Treatment and Labor Act.

OBJECTIVE: The Emergency Medical Treatment and Labor Act (EMTALA) is a federal law established in 1986 to ensure that patients who present to an emergency department receive medical care regardless of means. Violations are reported to the Centers for Medicare and Medicaid Services and can result in significant financial penalties. Our objective was to assess all available EMTALA violations for vascular-related issues. METHODS: EMTALA violations in the Centers for Medicare and Medicaid Services publicly available hospital violations database from 2011 to 2018 were evaluated for vascular-related issues. Details recorded were case type, hospital type, hospital region, reasons for violation, disposition, and mortality. RESULTS: There were 7001 patients identified with any EMTALA violation and 98 (1.4%) were deemed vascular related. The majority (82.7%) of EMTALA violations occurred at urban/suburban hospitals. Based on the Association of American Medical Colleges United States region, vascular-related EMTALA violations occurred in the Northeast (7.1%), Southern (56.1%), Central (18.4%), and Western (18.4%) United States. Case types included cerebrovascular (28.6%), aortic related (22.4%; which consisted of ruptured aortic aneurysms [8.2%], aortic dissection [11.2%], and other aortic [3.1%]), vascular trauma (15.3%), venous-thromboembolic (15.3%), peripheral arterial disease (9.2%), dialysis access (5.1%), bowel ischemia (3.1%), and other (1%) cases. Patients were transferred to another facility in 41.8% of cases. The most common reasons for violation were specialty refusal or unavailability (30.6%), inappropriate documentation (29.6%), misdiagnosis (18.4%), poor communication (17.3%), inappropriate triage (13.3%), failure to obtain diagnostic laboratory tests or imaging (12.2%), and ancillary or nursing staff issues (7.1%). The overall mortality was 19.4% and 31.6% died during the index emergency department visit. Vascular conditions associated with death were venous thromboembolism (31.6%), ruptured aortic aneurysm (21.1%), aortic dissection (21.1%), other aortic causes (10.5%), vascular trauma (10.5%), and bowel ischemia (5.3%). CONCLUSIONS: Although the frequency of vascular-related EMTALA violations was low, improvements in communication, awareness of vascular disease among staff, specialty staffing, and the development of referral networks and processes are needed to ensure that patients receive adequate care and that institutions are not placed at undue risk.

Clinical Negligence Claims Against Vascular Surgery in the United Kingdom: An Observational Study.

BACKGROUND: Claims for clinical negligence awarded to patients and their families are on the increase. The annual "cost of harm" is approximately £7-9 billion in the United Kingdom. In 2017, the National Health Service (NHS) resolution service reported that they mediated more claims than in their entire history. Vascular surgery is a specialty with a disproportionately higher number of claims for clinical negligence. The aim of this observational study was to review the trends of clinical negligence claims in vascular surgery within the United Kingdom. The costs and the primary cause for the complaint were evaluated. METHODS: A retrospective observational study was performed. Clinical negligence claims in vascular surgery between the financial years of April 2005/2006 to April 2018/2019 were requested from NHS resolution under the Freedom of Information Act. Data were provided on November 8, 2019. All data were anonymized, and any categories containing fewer than five claims were removed to protect the identity of claimants. RESULTS: Over the 13-year period, 1,189 claims in vascular surgery were identified, with the annual mean (range) being 91 (20-134) claims per year. Of 1,189 claims, 875 (74%) are closed with payments made to the claimants. The mean annual total payment was £10,015,373. Delay in treatment was the most common cause for litigation claims in vascular surgery with 157 closed claims costing £33,255,248 over the 13-year period. Lower limb amputation was the most common primary injury claim with 140 closed cases but had a larger financial cost at £64,155,969. CONCLUSIONS: Clinical negligence claims in vascular surgery within the United Kingdom have been increasing steadily over the last 13 years and with a changing claims culture is expected to continue. The most common cause for claims with damages paid was delay in treatment, and lower limb amputation was the most common injury suffered. Improved consent, better communication with patients, and a higher surgical skill level could significantly reduce the number of future claims.

Experience from a Singapore tertiary hospital with restructuring of a vascular surgery practice in response to national and institutional policies during the COVID-19 pandemic.

Singapore was one of the first countries to be affected by COVID-19, with the index patient diagnosed on January 23, 2020. For 2 weeks in February, we had the highest number of COVID-19 cases behind China. In this article, we summarize the key national and institutional policies that were implemented in response to COVID-19. We also describe in detail, with relevant data, how our vascular surgery practice has changed because of these policies and COVID-19. We show that with a segregated team model, the vascular surgery unit can still function while reducing risk of cross-contamination. We explain the various strategies adopted to reduce outpatient and inpatient volume. We provide a detailed breakdown of the type of vascular surgical cases that were performed during the COVID-19 pandemic and compare it with preceding months. We discuss our operating room and personal protective equipment protocols in managing a COVID-19 patient and share how we continue surgical training amid the pandemic. We also discuss the challenges we might face in the future as COVID-19 regresses.

COVID-19 financial resources for physicians.

The appropriate focus in managing the COVID-19 pandemic in the United States has been addressing access and delivery of care to the population affected by the outbreak. All sectors of the U.S. economy have been significantly affected, including physicians. Physician groups of all specialties and sizes have experienced the financial effects of the pandemic. Hospitals have received billions of dollars to support and enable them to manage emergencies and cover the costs of the disruption. However, many vascular surgeons are under great financial pressure because of the postponement of all nonemergency procedures. The federal government has announced a myriad of programs in the form of grants and loans to reimburse physicians for some of their expenses and loss of revenue. It is more than likely that unless the public health emergency subsides significantly, many practices will experience dire consequences without additional financial assistance. We have attempted to provide a concise listing of such programs and resources available to assist vascular surgeons who are small businesses in accessing these opportunities.

Malpractice Litigation for Compartment Syndrome.

BACKGROUND: The aim of this study was to analyze litigation involving compartment syndrome to identify the causes and outcomes of such malpractice suits. A better understanding of such litigation may provide insight into areas where clinicians may make improvements in the delivery of care. METHODS: Jury verdict reviews from the Westlaw database from January 1, 2010 to January 1, 2018 were reviewed. The search term "compartment syndrome" was used to identify cases and extract data on the specialty of the physician defendant, the demographics of the plaintiff, the allegation, and the verdict. RESULTS: A total of 124 individual cases involving the diagnosis of compartment syndrome were identified. Medical centers or the hospital was included as a defendant in 51.6% of cases. The most frequent physician defendants were orthopedic surgeons (45.96%) and emergency medicine physicians (20.16%), followed by cardiothoracic/vascular surgeons (16.93%). Failure to diagnose was the most frequently cited claim (71.8% of cases). Most plaintiffs were men, with a mean age of 36.7 years, suffering injuries for an average of 5 years before their verdict. Traumatic compartment syndrome of the lower extremity causing nerve damage was the most common complication attributed to failure to diagnose, leading to litigation. Forty cases (32.25%) were found for the plaintiff or settled, with an average award of $1,553,993.66. CONCLUSIONS: Our study offers a brief overview of the most common defendants, plaintiffs, and injuries involved in legal disputes involving compartment syndrome. Orthopedic surgeons were most commonly named; however, vascular surgeons may also be involved in these cases because of the large number of cases with associated arterial involvement. A significant percentage of cases were plaintiff verdicts or settled cases. Failure to diagnosis or delay in treatment was the most common causes of malpractice litigation. Compartment syndrome is a clinical diagnosis and requires a high level of suspicion for a timely diagnosis. Lack of objective criteria for diagnosis increases the chances of medical errors and makes it an area vulnerable to litigation.

The Impact of the Affordable Care Act Medicaid Expansion on Vascular Surgery.

BACKGROUND: The Affordable Care Act (ACA) Medicaid expansion increased Medicaid eligibility such that all adults with an income level up to 138% of the federal poverty threshold in 2014 qualified for Medicaid benefits. Prior studies have shown that the ACA Medicaid expansion was associated with increased access to care. The impact of the ACA Medicaid expansion on patients undergoing complex care for major vascular pathology has not been evaluated. METHODS: The Healthcare Cost and Utilization Project State Inpatient Database was used to identify patients undergoing care for major vascular pathology in 6 states from 2010 to 2014. The analysis cohort included adult patients between the ages of 18 and 64 years who underwent a nonemergent surgical procedure for an abdominal aortic aneurysm, thoracic aortic aneurysm, carotid artery stenosis, peripheral vascular disease, or chronic kidney disease. Poisson regression was used to determine the incidence rate ratios (IRRs). RESULTS: There were a total of 83,960 patients in the study cohort. Compared with nonexpansion states, inpatient admissions for Medicaid patients with an abdominal or thoracic aneurysm and carotid stenosis diagnosis increased significantly (IRR, 1.20, 1.27, 1.06, respectively; P < 0.05) in states that expanded Medicaid. Vascular-related surgeries increased for carotid endarterectomy, lower extremity revascularization, lower extremity amputation, and arteriovenous fistula in expansion states (IRR, 1.24, 1.10, 1.11, 1.16, respectively; P < 0.05) compared with nonexpansion states. CONCLUSIONS: In states that expanded Medicaid coverage under the ACA, the rate of vascular-related surgeries and admissions for Medicaid patients increased. We conclude that expanding insurance coverage results in enhanced access to vascular surgery.

Effects of the Affordable Care Act on Vascular Patient Amputation Rates in Arkansas.

BACKGROUND: The Patient Protection and Affordable Care Act was signed into law in 2010 and enacted in 2013 which improved insurance coverage across America due to increasing Medicaid eligibility as well as changes to individual insurance markets. In Arkansas, this was implemented by a Medicaid expansion waiver which allowed patients to purchase insurance with funds provided by the government to subsidize premiums through the marketplace. The goal of this study was to determine the effects of the Affordable Care Act (ACA) on Arkansas patients with peripheral arterial disease. METHODS: A pre-post research design using the Arkansas Hospital Discharge Dataset was used to study the impact of the ACA on limb amputation, distal bypass, discharge disposition, and total costs for patients diagnosed with peripheral arterial disease/atherosclerosis. The data were obtained for the years 2007 through 2009 (pre-ACA), 2011 through 2013 (post-ACA), and 2014 through 2015 (post-Arkansas expansion). Bivariate analysis, analysis of variance, and regression analyses were performed to analyze the data. RESULTS: A total of 10,923 patients were identified. Uninsured patients ("self-pay") decreased from 7% pre-ACA to 3.4% post-Arkansas expansion (P < 0.0001). There was a decrease in adjusted health-care costs after the Arkansas expansion (P < 0.0001). There was no change in mortality or transfer to rehabilitation facilities, but there was an increase in discharge to skilled nursing facilities along with a decrease in patients being discharged home (P < 0.0001). Regression analysis showed private insurance to be associated with a 49% reduction in the odds of an amputation (P < 0.0001). The Arkansas expansion was associated with a 26% reduction in the odds of an amputation when compared with that before the ACA implementation (P < 0.005). Having private insurance was associated with a 26% increase in the odds of having a bypass when compared with uninsured patients (P < 0.05). CONCLUSIONS: Patients with private insurance have a decreased chance of amputation and increased odds of having a bypass when compared with patients who were of the self-pay category. The increase in private insurance coverage in our patient population could improve the rate of amputation in the vascular population in Arkansas by increasing early interventions for peripheral vascular disease.

Outcomes and associated factors in malpractice litigation involving inferior vena cava filters.

OBJECTIVE: Placement of inferior vena cava (IVC) filters is a controversial focus of medical malpractice. Clinicians currently have little information to guide them regarding key issues and outcomes in litigation. In this retrospective legal case review, we analyzed the factors associated with malpractice actions involving IVC filters. METHODS: The legal databases LexisNexis and Westlaw were searched from 1967 to 2016 for all published legal cases in the United States involving placement of IVC filters. Keywords included "IVC," "inferior vena cava," "filter," and "malpractice." Social Security Disability claims, product liability actions, and hospital employment contract disputes were excluded. RESULTS: There were 310 search results eligible for initial review. After application of exclusion criteria, 29 cases involving medical malpractice were included in final analysis. The majority of excluded cases were insurance disputes and tax revenue cases. Overall, private practitioners were most often sued (11/29 [37.9%]), whereas 24.1% of defendants were academic hospitals (7/29), 20.7% were prisons (6/29), and 17.2% were community hospitals (5/29). The most common specialty named was vascular surgery (8/29), whereas interventional radiologists were named only twice. The most common indications for IVC filter placement were hypercoagulable state (8/29 [29.6%]), recurrent pulmonary embolism (PE; 6/29 [22.2%]), and trauma (5/29 [18.5%]). The most common underlying allegations involved failure to insert IVC filter when indicated (14/29 [48.3%]), intraprocedural negligence (5/29 [17.2%]), and failure to timely remove device (5/29 [17.2%]). Common complications included failure to prevent occurrence of PE (14/29 [48.3%]), device migration (4/29 [13.8%]), and perforation of organs or vasculature (3/29 [10.3%]). Death of the patient occurred in 41.4% of total cases (12/29). In cases in which the patient died, the most common indications for filter placement were trauma (4/12 [33.3%]) and deep venous thrombosis (3/12 [25.0%]), and the most common complication in those patients who died was the failure to prevent a subsequent PE (9/12 [75.0%]). Available verdicts favored defendants (13/14 [92.9%]). In cases with defense verdicts, the most common indications for filter placement similarly were trauma (4/13 [30.8%]) and deep venous thrombosis (3/13 [23.1%)], and the most common complication was failure to prevent PE (9/14 [64.3%]). CONCLUSIONS: Analysis of malpractice cases involving IVC filters revealed key factors associated with litigation. Overall, verdicts favored defendants. Private practitioners were most commonly sued, and the most common reasons for bringing suit were failure to insert filter, intraprocedural complications, and failure to remove filter. Deeper awareness of issues related to malpractice litigation can inform clinical practice and improve patient care and safety.

A Unique All-Payer Rate-Setting System Controls the Cost but Not the Racial Disparity in Lower Extremity Revascularization Procedures.

BACKGROUND: Patients with peripheral arterial disease often have high comorbidity burden that may complicate post-interventional course and drive increased health-care expenditures. Racial disparity had been observed in lower extremity revascularization (LER) patterns and outcomes. In 2014, Maryland adopted an all-payer rate-setting system to limit the rising hospitalization costs. This resulted in an aggregate payment system in which hospital compensation takes place as an overall per capita expenditure for hospital services. We sought to examine racial differences and other patient-level factors that might lead to discrepancies in LER hospital costs in the State of Maryland. METHODS: We used International Classification of Diseases, Ninth Revision codes to identify patients who underwent infrainguinal open bypass (open) and endovascular repair (endo) in the Maryland Health Services Cost Review Commission database (2009-2015). Multivariable generalized linear model regression analysis was conducted to report cost differences adjusting for patient-specific demographics, comorbidities, and insurance status. Logistic regression analysis was used to assess quality metrics: intensive care unit (ICU) admission, 30-day readmission, protracted length of stay (pLOS) (endo: pLOS >9, open: pLOS > 10 days) and in-hospital mortality. RESULTS: Among patients undergoing open, costs were higher for nonwhite patients (African-American [AA]: $6,092 [4,682-7,501], other: $3,324 [437-6,212]; both P ≤ 0.024), diabetics ($2,058 [837-3,279]; P < 0.001), and patients with Medicaid had an increased cost over Medicare patients by $4,325 (1,441-7,209). Critical limb ischemia (CLI) was associated with $5,254 (4,014-6,495) risk-adjusted cost increment. In addition, AA patients demonstrated higher risk-adjusted odds of ICU admission (adjusted odds ratio [aOR] [95% confidence interval {CI}]:1.65 [1.46-1.86]; P < 0.001) and pLOS (aOR [95% CI]: 1.56 [1.37-1.79]; P < 0.001) than their white counterparts. For patients undergoing endo, costs were higher for nonwhite patients (AA: $2,642 [1,574-3,711], other: $4,124 [2,091-6,157]; both P < 0.001). Patients with CLI and heart failure had increased costs after endo. AA patients were more likely to be readmitted or stayed longer after endo (1.16 [1.03-1.29], 1.34 [1.21-1.49]; both P < 0.010, respectively). The overall cost trend was rapidly increasing before all-payer rate policy implementation but it dramatically plateaued after 2014. CONCLUSIONS: This study showed that the all-payer rate-setting system has curbed the LER rising costs, but these costs remained disproportionally higher for disadvantaged populations such as AA and Medicaid communities. This underpins the existing racial disparity in LER. AA patients had higher LER costs, most likely driven by extended hospitalization and ICU admission. Efforts could be directed to evaluate the contributing socioeconomic factors, invest in primary prevention of comorbid conditions that had shown to be associated with prohibitive costs, and identify mechanisms to overcome the existing racial disparity in LER within the promising cost-saving payment system at the State of Maryland.