Disparities in Access to Outpatient Surgery Related to Removal of Procedures from Medicare's Inpatient Only List.

OBJECTIVE: We assessed the shift from inpatient to outpatient surgical care related to changes to the Inpatient Only List in 2020 and 2021 compared to 2019. SUMMARY BACKGROUND DATA: The extent to which procedures shift from the inpatient to outpatient setting following removal from Medicare's Inpatient Only List is unknown. Many health systems also encouraged a shift from inpatient to outpatient surgery during the COVID-19 pandemic. Assessing the relative change in outpatient surgical utilization for procedures removed from the Inpatient Only List during COVID-19 would provide empirical data on whether reimbursement policy changes or inpatient capacity needs during the pandemic were more likely to shift care from the inpatient to outpatient setting. METHODS: We used administrative data from the PINC AI Healthcare Database across 723 hospitals to determine the within-facility relative change in outpatient vs inpatient procedural volume in 2020 and 2021 compared to 2019 using a multivariable conditional fixed-effects Poisson regression model. We also assessed whether outpatient surgical utilization varied by race and ethnicity. Using a multivariable linear probability model, we assessed the absolute change in risk-adjusted 30-day complication, readmission, and mortality rates for inpatient and outpatient surgical procedures. RESULTS: In 2020 and 2021 compared to 2019 respectively, there was a 5.3% (95% CI, 1.4% to 9.5%) and 41.3% (95% CI 33.1% to 50.0%) relative increase in outpatient elective procedural volume. Outpatient procedural volume increased most significantly for hip replacement which was removed from the Inpatient Only List in 2020 (increase in outpatient surgical utilization of 589.3% (95% CI, 524.9% to 660.3%)). The shift to outpatient hip replacement procedures was concentrated among White patients; in 2021, hip replacement procedural volume increased by 271.1% (95% CI, 241.2% and 303.7%) for White patients and 29.5% (95% CI, 24.4% and 34.9%) for Black patients compared to 2019 levels. There were no consistent or large changes in 30-day complication, readmission, or mortality risk in 2020 and 2021 compared to 2019. CONCLUSION: There was a modest increase in elective outpatient surgeries and a pronounced increase in outpatient orthopedic surgeries which were removed from the Inpatient Only List during the COVID-19 pandemic. Utilization of outpatient surgical procedures was concentrated among White patients.

Dyadic Investigation of Posttraumatic Stress Symptoms and Daily Sleep Health in Patients With Cancer and Their Caregivers.

OBJECTIVE: Cancer can be a traumatic experience affecting multidimensional aspects of sleep among patients and caregivers. This study examined the differential associations of cancer-related posttraumatic stress symptoms (PTSS) with various sleep markers in this population. METHODS: Patients newly diagnosed with colorectal cancer ( n = 138, mean age = 56.93 years, 31.88% female, 60.14% Hispanic, 6.53 months after diagnosis) and their sleep-partner caregivers ( n = 138, mean age = 55.32 years, 68.12% female, 57.97% Hispanic) completed questionnaires assessing the four PTSS clusters (intrusion, avoidance, alterations in arousal and reactivity, negative alterations in cognitions and mood). Participants also completed daily sleep diaries for 14 consecutive days, from which sleep onset latency (SOL), wake after sleep onset (WASO), and sleep duration were derived. RESULTS: Actor-partner interdependence model revealed that caregivers' greater alterations in arousal and reactivity were associated with their own longer SOL ( b = 15.59, p < .001) and their patients' longer sleep duration ( b = 0.61, p = .014), whereas patients' arousal and reactivity were associated with their caregivers' shorter SOL ( b = -8.47, p = .050). Patients' and caregivers' greater negative alterations in cognitions and mood were associated with patients' longer SOL ( b = 9.15, p = .014) and shorter sleep duration ( b = -0.41, p = .050), respectively. Caregivers' greater intrusion was related to their own shorter SOL ( b = -10.14, p = .004). CONCLUSIONS: The four PTSS clusters, particularly arousal and reactivity and negative cognitions and mood, have distinct associations with sleep markers individually and dyadically in patients and caregivers affected by cancer. Investigations of psychosocial and biobehavioral pathways underlying these relations are warranted. Tailored trauma treatments and sleep interventions may improve the well-being of this population.

National trends in utilization and safety of gastric bypass, sleeve gastrectomy and conversion surgery in patients with GERD.

BACKGROUND: While some studies have reported improvement in gastro-esophageal reflux disease (GERD) symptoms after sleeve gastrectomy (SG), others have reported higher incidence of de-novo GERD, worsening of prior GERD symptoms and erosive esophagitis post SG. Furthermore, GERD unresponsive to medical management is one of the most common indications for conversion of SG to Roux-en-Y gastric bypass (RYGB). Real-world data on safety of primary SG, primary RYGB and SG to RYGB conversion for obese patients with GERD would be helpful for informing surgeons and patient procedure selection. We sought to evaluate the trends in utilization and safety of primary RYGB and primary SG for patients with GERD requiring medications, and compare the peri-operative outcomes between primary RYGB and conversion surgery from SG to RYGB for GERD using the MBSAQIP database. METHODS: A comparative analysis of post-operative outcomes within 30 days was performed for primary RYGB and primary SG after 1:1 nearest neighbor propensity score matching for patient demographics and preoperative comorbidities using the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP) registry from 2015 to 2021. This was followed by comparison of peri-operative outcomes between conversion surgery from SG to RYGB for GERD and primary RYGB using MBSAQIP 2020-2021 data. RESULTS: Utilization of primary RYGB increased from 38% in 2015 to 45% in 2021, while primary SG decreased from 62% in 2015 to 55% in 2021 for bariatric patients with GERD. Post-operative outcomes including reoperation, reintervention, readmission, major complications, and death within 30 days were significantly higher for patients undergoing primary RYGB compared to primary SG. Increased readmissions and ED visits were seen with conversion surgery. However, there was no difference in rates of reoperation, reintervention, major complications, or death between primary RYGB and SG conversion to RYGB cohorts. CONCLUSIONS: This data suggests that a strategy of performing a primary SG and subsequent SG-RYGB conversion for those with recalcitrant GERD symptoms is not riskier than a primary RYGB. Thus, it may be reasonable to perform SG in patients who are well informed of the risk of worsening GERD requiring additional surgical interventions. However, the impact of such staged approach (SG followed by conversion to RYGB) on long-term outcomes remains unknown.

Dyadic sleep intervention for adult patients with cancer and their sleep-partner caregivers: A feasibility study.

OBJECTIVES: Sleep disturbances are common among adult patients with cancer and their caregivers. To our knowledge, no sleep intervention to date has been designed to be provided to both patients with cancer and their caregivers simultaneously. This single-arm study aimed to pilot test the feasibility and acceptability, and to illustrate the preliminary efficacy on sleep efficiency of the newly developed dyadic sleep intervention, My Sleep Our Sleep (MSOS: NCT04712604). METHODS: Adult patients who were newly diagnosed with a gastrointestinal (GI) cancer and their sleep-partner caregivers (n = 20 persons: 10 dyads, 64 years old, 60% female patients, 20% Hispanic, 28 years relationship duration), both of whom had at least mild levels of sleep disturbance (Pittsburgh Sleep Quality Index [PSQI] ≥ 5) participated in this study. MSOS intervention consists of four 1-hour weekly sessions delivered using Zoom to the patient-caregiver dyad together. RESULTS: We were able to enroll 92.9% of the eligible and screened patient-caregiver dyads within 4 months. Participants reported high satisfaction in 8 domains (average 4.76 on a 1-5 rating). All participants agreed that the number of sessions, interval (weekly), and delivery mode (Zoom) were optimal. Participants also preferred attending the intervention with their partners. Both patients and caregivers showed improvement in sleep efficiency after completing the MSOS intervention: Cohen's d = 1.04 and 1.47, respectively. SIGNIFICANCE OF RESULTS: Results support the feasibility and acceptability, as well as provide the preliminary efficacy of MSOS for adult patients with GI cancer and their sleep-partner caregivers. Findings suggest the need for more rigorous controlled trial designs for further efficacy testing of MSOS intervention.

Longitudinal Trends in 30-Day Mortality Between Multi-Site and Single-Site Surgeons.

BACKGROUND: Quality leaders are concerned that creation of multi-hospital health systems may lead to surgeons traveling to and from distant hospitals and thus to more fragmented surgical care and worse outcomes for their patients. Despite this concern, little empirical data exist on outcomes of multi-site versus single-site surgeons. METHODS: Using national Medicare data, we assessed trends in the number of multi-site vs. single-site surgeons from 2011 to 2016. We performed a multivariable regression analysis to compare overall 30-day mortality differences, stratified by system and rural status, and examined trends over time. RESULTS: The number of multi-site surgeons and the percentage of multi-site surgeons per hospital decreased over time (24.2%-19.0%; 44.3%-41.8%). Overall, multi-site surgeons had lower 30-day mortality than single-site surgeons (2.24% vs 2.50%, P < 0.01). When stratified by system status, multi-site surgeons performed better in-system (2.47% vs 2.58%, P < 0.01); by rural status, multi-site surgeons had lower mortality in non-rural hospitals (2.42% vs 2.51%, P < 0.01). The statistically significant but small mortality advantage of multi-site versus single-site surgeons decreased over time, such that by 2016 there was no difference in outcomes between multi-site and single-site surgeons. CONCLUSION: For the majority of study years, multi-site surgeons had lower 30-day mortality than single-site surgeons, but this trend narrowed until outcomes were equivalent by 2016. Surgeons operating at multiple hospitals can provide surgical care to patients without any evidence of increased mortality.

Impact of the COVID-19 Pandemic on Inpatient and Outpatient Utilization of Bariatric Surgery.

BACKGROUND: During the COVID-19 pandemic, deferral of inpatient elective surgical procedures served as a primary mechanism to increase surge inpatient capacity. Given the benefit of bariatric surgery on treating obesity and associated comorbidities, decreased access to bariatric surgery may have long-term public health consequences. Understanding the extent of the disruption of the COVID-19 pandemic to bariatric surgery will help health systems plan for appropriate access. MATERIALS AND METHODS: This is an observational cohort study using the PINC AI Healthcare Database from 1/1/2019-6/31/2021. A Poisson regression model with patient characteristics and hospital-fixed effects was used to assess the relative monthly within-hospital reduction in surgical encounters, variations by race and ethnicity, and shift from inpatient to outpatient procedures. A multivariate linear probability model was used to assess the change in 30-day readmissions from 2020 and 2021 compared to 2019. RESULTS: Among 309 hospitals, there were 46,539 bariatric procedures conducted in 2019 with a 14.8% reduction in volume to 39,641 procedures in 2020. There were 22,642 bariatric procedures observed from January to June of 2021. The most pronounced decrease in volume occurred in April with an 89.7% relative reduction from 2019. Black and Hispanic patients were more likely to receive bariatric surgery after the height of the pandemic compared to white patients. A clinically significant shift from inpatient to outpatient bariatric surgical procedures was not observed. Relative to 2019, there were no significant differences in bariatric surgical readmission rates. CONCLUSION: During the pandemic there was a sizable decrease in bariatric surgical volume. There did not appear to be disparities in access to bariatric surgery for minority patients. We did not observe a meaningful shift toward outpatient bariatric surgical procedures. Post-pandemic, monitoring is needed to assess if hospitals have been able to meet the demand for bariatric surgical procedures.

Relationship Between Health Care Spending and Clinical Outcomes in Bariatric Surgery: Implications for Medicare Bundled Payments.

OBJECTIVE: To evaluate sources of 90-day episode spending variation in Medicare patients undergoing bariatric surgery and whether spending variation was related to quality of care. SUMMARY OF BACKGROUND DATA: Medicare's bundled payments for care improvement-advanced program includes the first large-scale episodic bundling program for bariatric surgery. This voluntary program will pay bariatric programs a bonus if 90-day spending after surgery falls below a predetermined target. It is unclear what share of bariatric episode spending may be due to unnecessary variation and thus modifiable through care improvement. METHODS: Retrospective analysis of fee-for-service Medicare claims data from 761 acute care hospitals providing inpatient bariatric surgery between January 1, 2011 and September 30, 2016. We measured associations between patient and hospital factors, clinical outcomes, and total Medicare spending for the 90-day bariatric surgery episode using multivariable regression models. RESULTS: Of 64,537 patients, 46% underwent sleeve gastrectomy, 22% revisited the emergency department (ED) within 90 days, and 12.5% were readmitted. Average 90-day episode payments were $14,124, ranging from $12,220 at the lowest-spending quintile of hospitals to $16,887 at the highest-spending quintile. After risk adjustment, 90-day episode spending was $11,447 at the lowest quintile versus $15,380 at the highest quintile (difference $3932, P < 0.001). The largest components of spending variation were readmissions (44% of variation, or $2043 per episode), post-acute care (19% or $871), and index professional fees (15% or $450). The lowest spending hospitals had the lowest complication, ED visit, post-acute utilization, and readmission rates (P < 0.001). CONCLUSIONS AND RELEVANCE: In this retrospective analysis of Medicare patients undergoing bariatric surgery, the largest components of 90-day episode spending variation are readmissions, inpatient professional fees, and post-acute care utilization. Hospitals with lower spending were associated with lower rates of complications, ED visits, post-acute utilization, and readmissions. Incentives for improving outcomes and reducing spending seem to be well-aligned in Medicare's bundled payment initiative for bariatric surgery.

Paclitaxel-coated devices in the treatment of femoropopliteal stenosis among patients ≥65 years old: An ACC PVI Registry Analysis.

BACKGROUND: The connection between paclitaxel-coated devices (PCD) use during peripheral vascular interventions (PVI) and mortality is debated. We aimed to analyze patterns of PCD use and the safety and effectiveness of PCD use in the superficial femoral and/or popliteal arteries. METHODS: Patients undergoing PVI of femoropopliteal lesions with and without PCD between January 1, 2015 and June 30, 2017 were compared using the American College of Cardiology's National Cardiovascular Data Registry PVI Registry. Outcomes were derived from Centers for Medicare & Medicaid claims data. The primary outcome was all-cause mortality at 6-, 12-, and 24-months following PVI. Inverse probability weighting and frailty models were used to assess the differences between groups. The analysis was IRB-approved. RESULTS: In the overall cohort consisting of 6,302 femoropopliteal PVIs, PCD-PVI patients were more likely to be treated for claudication (63.5% vs 51.3%, P< .001), less likely to have a chronic total occlusion (24.6% vs 34.7%, P < .001), and more likely to be treated in certain geographic and practice settings. In the analytic cohort consisting of 1,666 femoropopliteal PVIs with linked claims outcomes (888 PCD-PVI, 53.3%), unadjusted rates of all outcomes were lower in PCD-PVI patients. After adjustment, there were no significant differences in mortality following PCD-PVI versus non-PCD PVI at 1 year (adjusted RR 0.78, 95% CI 0.60-1.01, P= .055) or 2 years (aRR 0.98, 95% CI 0.77-1.24, P= .844). CONCLUSION: There were significant differences between the patients in whom and settings in which PCD-PVI was versus was not used. PCD-PVI was not associated with an increased risk of 2-year mortality in real-world use.

Racial Disparity in Pancreatoduodenectomy for Borderline Resectable Pancreatic Adenocarcinoma.

BACKGROUND: Previous studies have found racial disparity in pancreatectomies for resectable pancreatic adenocarcinoma. The aim of this study was to investigate if racial disparities were worse in the performance of pancreaticoduodenectomy for borderline resectable pancreatic adenocarcinoma. METHODS: This study used the National Cancer Database (2004-2016) and included patients with non-metastatic and head of the pancreas borderline resectable pancreatic adenocarcinoma. Multivariable, Poisson regression models with robust standard errors evaluated the relative risk (RR) of undergoing a pancreaticoduodenectomy among non-White patients (Black, Asian, and non-White Hispanic) compared with White patients. A Poisson regression model with hospital fixed effects was performed to evaluate if findings were due to within-hospital or between-hospital variation. Interaction between race and neoadjuvant therapy was also evaluated. RESULTS: There were 15,482 patients (median age 68 years, interquartile range 60-76 years; 48.6% male) with borderline resectable pancreatic adenocarcinoma who were predominantly White (84.3%, n = 13,058; non-White, 15.7%, n = 2424). Overall, 18.4% (n = 2853) had a pancreatic resection. Non-White patients had a significantly lower likelihood of undergoing a pancreatic resection for borderline resectable pancreatic adenocarcinoma when compared with White patients (RR 0.75, 95% confidence interval 0.68-0.83; p < 0.001). These findings persisted in the hospital fixed-effects model. In the interaction analysis, there were no significant differences in the likelihood of pancreatic resection if patients received neoadjuvant therapy. CONCLUSIONS: Non-White patients were 25% less likely to undergo a pancreatic resection for borderline resectable pancreatic adenocarcinoma compared with White patients. This racial disparity was due to variation in care within-hospitals and disappeared if non-White patients were treated with neoadjuvant therapy.

Development and validation of a predictive model for bleeding after peripheral vascular intervention: A report from the National Cardiovascular Data Registry Peripheral Vascular Interventions Registry.

OBJECTIVES: To develop a model to predict risk of in-hospital bleeding following endovascular peripheral vascular intervention. BACKGROUND: Peri-procedural bleeding is a common, potentially preventable complication of catheter-based peripheral vascular procedures and is associated with increased mortality. We used the National Cardiovascular Data Registry (NCDR) Peripheral Vascular Interventions (PVI) Registry to develop a novel risk-prediction model to identify patients who may derive the greatest benefit from application of strategies to prevent bleeding. METHODS: We examined all patients undergoing lower extremity PVI at 76 NCDR PVI hospitals from 2014 to 2017. Patients with acute limb ischemia (n = 1600) were excluded. Major bleeding was defined as overt bleeding with a hemoglobin (Hb) drop of ≥ 3 g/dl, any Hb decline of ≥ 4 g/dl, or a blood transfusion in patients with pre-procedure Hb ≥ 8 g/dl. Hierarchical multivariable logistic regression was used to develop a risk model to predict major bleeding. Model validation was performed using 1000 bootstrapped replicates of the population after sampling with replacement. RESULTS: Among 25,382 eligible patients, 1017 (4.0%) developed major bleeding. Predictors of bleeding included age, female sex, critical limb ischemia, non-femoral access, prior heart failure, and pre-procedure hemoglobin. The model demonstrated good discrimination (optimism corrected c-statistic = 0.67), calibration (corrected slope = 0.98, intercept of -0.04) and range of predicted risk (1%-18%). CONCLUSIONS: Post-procedural PVI bleeding risk can be predicted based upon pre- and peri-procedural patient characteristics. Further studies are needed to determine whether this model can be utilized to improve procedural safety through developing and targeting bleeding avoidance strategies.

The Affordable Care Act at 10 Years: Evaluating the Evidence and Navigating an Uncertain Future.

The year 2020 marks the 10th anniversary of the signing of the Affordable Care Act (ACA). Perhaps the greatest overhaul of the US health care system in the past 50 y, the ACA sought to expand access to care, improve quality, and reduce health care costs. Over the past decade, there have been a number of challenges and changes to the law, which remains in evolution. While the ACA's policies were not intended to specifically target surgical care, surgical patients, surgeons, and the health systems within which they function have all been greatly affected. This article aims to provide a brief overview of the impact of the ACA on surgical patients in reference to its tripartite aim of improving access, improving quality, and reducing costs.

Association of balanced abdominal organ transplant center volumes with patient outcomes.

BACKGROUND: The volume-outcome relationship for organ-specific transplantation is well-described; it is unknown if the relative balance of kidney compared with liver volumes within an institution relates to organ-specific outcomes. We assessed the association between relative balance within a transplant center and outcomes. METHODS: National retrospective analysis of isolated kidney and liver transplants in United States 2005-2014 followed through 2019. Latent class analysis defined transplant center phenotypes. Multivariate Cox models estimated death-censored graft loss and mortality. RESULTS: Latent class analysis identified four phenotypes: kidney only (n = 117), kidney dominant (n = 36), mixed/balanced (n = 90), and liver dominant (n = 13). Compared to mixed centers, the risk of kidney graft loss was higher at kidney-dominant (HR 1.07, p < .001) and liver-dominant (HR 1.10, p < .001) centers, while kidney-only (HR 1.06, p = .01) centers had higher mortality. Liver graft loss was not associated with phenotype, but risk of patient death was lower (HR 0.93, p = .02) at liver dominant and higher (HR 1.06, p = .02) at kidney-dominant centers. CONCLUSIONS: A mixed phenotype was associated with improved kidney transplant outcomes, whereas liver transplant outcomes were best at liver-dominant centers. While these findings need to be verified with center-level resources, optimization of shared resources could improve patient and organ outcomes.

Expanding opportunities to understand quality and outcomes of peripheral vascular interventions: The ACC NCDR PVI Registry.

Lower extremity peripheral artery disease (PAD) and cerebrovascular disease (CeVD) are prevalent conditions in the United States, and both are associated with significant morbidity (eg, stroke, myocardial infarction, and limb loss) and increased mortality. With a growth in invasive procedures for PAD and CeVD, this demands a more clear responsibility and introduces an opportunity to study how patients are treated and evaluate associated outcomes. The American College of Cardiology (ACC) National Cardiovascular Data Registry (NCDR) Peripheral Vascular Intervention (PVI) Registry is a prospective, independent collection of data elements from individual patients at participating centers, and it is a natural extension of the already robust NCDR infrastructure. As of September 20, 2018, data have been collected on 45,316 lower extremity PVIs, 12,417 carotid artery stenting procedures, and 11,027 carotid endarterectomy procedures at 208 centers in the United States. The purpose of the present report is to describe the patient and procedural characteristics of the overall cohort and the methods used to design and implement the registry. In collecting these data, ACC and ACC PVI Registry have the opportunity to play a pivotal role in scientific evidence generation, medical device surveillance, and creation of best practices for PVI and carotid artery revascularization.

Cured into Destitution: Catastrophic Health Expenditure Risk Among Uninsured Trauma Patients in the United States.

OBJECTIVE: To characterize the economic hardship for uninsured patients admitted for trauma using catastrophic health expenditure (CHE) risk. BACKGROUND: Medical debts are the greatest cause of bankruptcies in the United States. Injuries are often unpredictable, expensive to treat, and disproportionally affect uninsured patients. Current measures of economic hardship are insufficient and exclude those at greatest risk. METHODS: We performed a retrospective review, using data from the 2007-2011 Nationwide Inpatient Samples of all uninsured nonelderly adults (18-64 yrs) admitted with primary diagnoses of trauma. We used US Census data to estimate annual postsubsistence income and inhospital charges for trauma-related admission. Our primary outcome measure was catastrophic health expenditure risk, defined as any charges ≥40% of annual postsubsistence income. RESULTS: Our sample represented 579,683 admissions for uninsured nonelderly adults over the 5-year study period. Median estimated annual income was $40,867 (interquartile range: $21,286-$71.733). Median inpatient charges were $27,420 (interquartile range: $15,196-$49,694). Overall, 70.8% (95% posterior confidence interval: 70.7%-71.1%) of patients were at risk for CHE. The risk of CHE was similar across most demographic subgroups. The greatest risk, however, was concentrated among patients from low-income communities (77.5% among patients in the lowest community income quartile) and among patients with severe injuries (81.8% among those with ISS ≥ 16). CONCLUSIONS: Over 7 in 10 uninsured patients admitted for trauma are at risk of catastrophic health expenditures. This analysis is the first application of CHE to a US trauma population and will be an important measure to evaluate the effectiveness of health care and coverage strategies to improve financial risk protection.

Registry Assessment of Peripheral Interventional Devices (RAPID): Registry assessment of peripheral interventional devices core data elements.

OBJECTIVE: The current state of evaluating patients with peripheral artery disease and more specifically of evaluating medical devices used for peripheral vascular intervention (PVI) remains challenging because of the heterogeneity of the disease process, the multiple physician specialties that perform PVI, the multitude of devices available to treat peripheral artery disease, and the lack of consensus about the best treatment approaches. Because PVI core data elements are not standardized across clinical care, clinical trials, and registries, aggregation of data across different data sources and physician specialties is currently not feasible. METHODS: Under the auspices of the U.S. Food and Drug Administration's Medical Device Epidemiology Network initiative-and its PASSION (Predictable and Sustainable Implementation of the National Registries) program, in conjunction with other efforts to align clinical data standards-the Registry Assessment of Peripheral Interventional Devices (RAPID) workgroup was convened. RAPID is a collaborative, multidisciplinary effort to develop a consensus lexicon and to promote interoperability across clinical care, clinical trials, and national and international registries of PVI. RESULTS: The current manuscript presents the initial work from RAPID to standardize clinical data elements and definitions, to establish a framework within electronic health records and health information technology procedural reporting systems, and to implement an informatics-based approach to promote the conduct of pragmatic clinical trials and registry efforts in PVI. CONCLUSIONS: Ultimately, we hope this work will facilitate and improve device evaluation and surveillance for patients, clinicians, health outcomes researchers, industry, policymakers, and regulators.

2018 ACC/HRS/NASCI/SCAI/SCCT Expert Consensus Document on Optimal Use of Ionizing Radiation in Cardiovascular Imaging-Best Practices for Safety and Effectiveness, Part 2: Radiological Equipment Operation, Dose-Sparing Methodologies, Patient and Medical Personnel Protection.

The stimulus to create this document was the recognition that ionizing radiation-guided cardiovascular procedures are being performed with increasing frequency, leading to greater patient radiation exposure and, potentially, to greater exposure to clinical personnel. While the clinical benefit of these procedures is substantial, there is concern about the implications of medical radiation exposure. ACC leadership concluded that it is important to provide practitioners with an educational resource that assembles and interprets the current radiation knowledge base relevant to cardiovascular procedures. By applying this knowledge base, cardiovascular practitioners will be able to select procedures optimally, and minimize radiation exposure to patients and to clinical personnel. "Optimal Use of Ionizing Radiation in Cardiovascular Imaging - Best Practices for Safety and Effectiveness" is a comprehensive overview of ionizing radiation use in cardiovascular procedures and is published online. To provide the most value to our members, we divided the print version of this document into 2 focused parts. "Part I: Radiation Physics and Radiation Biology" addresses radiation physics, dosimetry and detrimental biologic effects. "Part II: Radiologic Equipment Operation, Dose-Sparing Methodologies, Patient and Medical Personnel Protection" covers the basics of operation and radiation delivery for the 3 cardiovascular imaging modalities (x-ray fluoroscopy, x-ray computed tomography, and nuclear scintigraphy). For each modality, it includes the determinants of radiation exposure and techniques to minimize exposure to both patients and to medical personnel.

2018 ACC/HRS/NASCI/SCAI/SCCT Expert Consensus Document on Optimal Use of Ionizing Radiation in Cardiovascular Imaging-Best Practices for Safety and Effectiveness, Part 1: Radiation Physics and Radiation Biology: A Report of the American College of Cardiology Task Force on Expert Consensus Decision Pathways Developed in Collaboration With Mended Hearts.

The stimulus to create this document was the recognition that ionizing radiation-guided cardiovascular procedures are being performed with increasing frequency, leading to greater patient radiation exposure and, potentially, to greater exposure for clinical personnel. Although the clinical benefit of these procedures is substantial, there is concern about the implications of medical radiation exposure. The American College of Cardiology leadership concluded that it is important to provide practitioners with an educational resource that assembles and interprets the current radiation knowledge base relevant to cardiovascular procedures. By applying this knowledge base, cardiovascular practitioners will be able to select procedures optimally, and minimize radiation exposure to patients and to clinical personnel. Optimal Use of Ionizing Radiation in Cardiovascular Imaging: Best Practices for Safety and Effectiveness is a comprehensive overview of ionizing radiation use in cardiovascular procedures and is published online. To provide the most value to our members, we divided the print version of this document into 2 focused parts. Part I: Radiation Physics and Radiation Biology addresses the issue of medical radiation exposure, the basics of radiation physics and dosimetry, and the basics of radiation biology and radiation-induced adverse effects. Part II: Radiological Equipment Operation, Dose-Sparing Methodologies, Patient and Medical Personnel Protection covers the basics of operation and radiation delivery for the 3 cardiovascular imaging modalities (x-ray fluoroscopy, x-ray computed tomography, and nuclear scintigraphy) and will be published in the next issue of the Journal.