Long-term risk of reintervention after transcatheter aortic valve replacement.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) has surpassed surgical aortic valve replacement (SAVR) as the predominant mode of valve replacement for the treatment of severe aortic stenosis (AS). However, the long-term need for valvular reintervention after TAVR remains unknown. METHODS: Using data from the Medicare Fee for Service 100% dataset, all patients receiving TAVR between July 2011 and December 2020 were identified. Patients were categorized as receiving a valve reintervention (either surgical or transcatheter) or not using the appropriate International Classification of Diseases 10th Revision Procedure Coding System (ICD-10-PCS). A competing risk regression model was used to estimate the cumulative probability of valve reintervention. RESULTS: Of 230,644 TAVR patients were identified, of whom 1,880 received a reintervention. Patients receiving a reintervention were younger and more likely to be male. At 10 years, the crude rate of reintervention was 0.59% within a surviving cohort of 341 patients. After adjusting for the competing risk of death and other covariates, the adjusted cumulative incidence of reintervention at 10 years after TAVR was 1.63%. When the rate of reinterventions was compared between early (2011-2016) and later (2017-2020) time periods, the risk-adjusted rate of reintervention at 4 years had decreased over time (0.85% vs 0.51%). CONCLUSION: The 10-year risk of valve reintervention after TAVR is low and appears to be decreasing over time. Further research is necessary to determine the driving factors contributing to valve reintervention in the current era.

Use of iso-osmolar contrast media during endovascular revascularization is associated with a lower incidence of major adverse renal, cardiac, or limb events.

OBJECTIVE: We examined the association of iso-osmolar contrast media (IOCM) versus low-osmolar contrast media (LOCM) with major adverse renal, cardiovascular, or limb events in patients at high-risk of acute kidney injury (AKI) undergoing peripheral endovascular procedures. BACKGROUND: Procedural characteristics including iodinated contrast type and volume have been associated with adverse renal and cardiovascular outcomes in patients undergoing angiographic interventions. METHODS: Patients at high-risk of AKI, undergoing peripheral endovascular procedures were identified using the Premier Healthcare Database and separated into claudication and critical limb ischemia (CLI) cohorts. For each cohort, we compared IOCM versus LOCM for the primary endpoint of MARCE (major adverse renal or cardiovascular events) and secondary endpoints of major adverse renal events (MARE) and major adverse renal and limb events (MARLE). These outcomes were captured within the indexed hospitalization via adjusted multivariable regression analyses. RESULTS: Two procedure-based cohorts of high-risk patients were formed: claudication (N = 11,976) and CLI (N = 8713). Use of IOCM was associated with a significant absolute risk reduction (ARR) of 2.2% (p < 0.0001) for MARCE overall and in each cohort (claudication, 1.8%, p = 0.0070; CLI, 2.7%, p = 0.0054). The incidence of MARE and MARLE in the overall cohort was also lower with the use of IOCM: MARE (ARR = 1.4%, p = 0.0072) and MARLE (ARR = 2.0%, p = 0.0043). CONCLUSIONS: Using IOCM versus LOCM in patients at high-risk of adverse renal events undergoing peripheral endovascular procedures was independently associated with lower risk of MARCE, MARE, and MARLE.

The need for future coronary access following surgical or transcatheter aortic valve replacement.

The aim of the study was to estimate the percentage of Medicare patients needing coronary access for percutaneous coronary intervention (PCI) or coronary angiography following aortic valve replacement (AVR). Indications for TAVR have expanded to include younger and low-risk patients, raising the question of coronary access for future procedures. Medicare patients <80 years old with an AVR between 2011 and 2018 were included. Time-to-event analyses were conducted using Cox hazard models to estimate risk of coronary access up to 7 years after AVR. Model adjustments included age, sex, race, region, comorbidity, concomitant CABG, and smoking. A total of 13,469 Medicare patients (mean age 70.6) met inclusion criteria. Models estimated that 2.5% of patients at 1-year post-index and 17% at over 7 years would need coronary access. For patients who had SAVR (with or without CABG), estimates for coronary access were similar and over 15% after 6.5 years. For TAVR patients, with a previous PCI, 28% at 4.5 years required coronary access, which was higher than TAVR patients without a previous PCI. SAVR patients with and without CAD at baseline were similar; however, TAVR patients with CAD had a 22% rate of coronary access versus 7% for those without at 3 years. Approximately half of patients who needed coronary access returned to the same hospital as their initial AVR. Coronary access is required in a substantial portion of AVR patients especially those with PCI or a history of CAD undergoing TAVR. The need for coronary access may increase as transcatheter AVR becomes accessible to younger patients with a longer life expectancy.

Rate of major adverse renal or cardiac events with iohexol compared to other low osmolar contrast media during interventional cardiovascular procedures.

OBJECTIVE: This study assessed the rate of major adverse renal or cardiac events (MARCE) when iohexol is used during interventional cardiovascular procedures compared to other low osmolar contrast media (LOCMs). BACKGROUND: Interventional cardiovascular procedures are often essential for diagnosis and treatment, the risk of MARCE should be considered. METHODS: Data were derived from the Premier Hospital Database January 1, 2010 through September 30, 2015. Patient encounters with an inpatient primary interventional cardiovascular procedure with a single LOCM (iohexol, ioversol, ioxilan, ioxaglate, or iopamidol) were included. The primary outcome was a composite endpoint of MARCE, which included: renal failure with dialysis, acute kidney injury (AKI) with or without dialysis, contrast induced AKI, acute myocardial infarction, angina, stent occlusion/thrombosis, stroke, transient ischemic attack, or death. Multivariable regression analysis was performed using the hospital fixed-effects specification to assess the relationship between MARCE and iohexol compared to other LOCMs, while controlling for patient demographics, comorbid conditions and reason for hospitalization. As a sensitivity analysis, direct comparisons of iohexol were made to other LOCMs. RESULTS: A total of 458,091 inpatient encounters met inclusion criteria of which 26% used iohexol and 74% used other LOCMs. Results of multivariable modeling revealed no differences in MARCE rates between iohexol and other LOCMs. When direct comparisons of iohexol vs. ioversol and iopamidol were modeled, no differences in MARCE nor the renal component of MARCE were found. CONCLUSIONS: In this retrospective multicenter study, there were no differences in MARCE events with iohexol compared to other LOCMs during inpatient interventional cardiovascular procedures.

Systemic opioid elimination after implantation of an intrathecal drug delivery system significantly reduced health-care expenditures.

OBJECTIVE: To compare health-care expenditures over a 12-month horizon for chronic pain patients with implanted intrathecal drug delivery systems (IDDS) who eliminated or continued systemic opioids postimplant. METHODS: Claims data from commercial and Medicare databases were searched for patients who had an IDDS, used systemic opioids before implant, and had 12 months pre- and 13 months postimplant continuous medical and pharmacy coverage. The number and characteristics of patients who eliminated or continued systemic opioids were determined at four times postimplant: 30 days (allowing a systemic opioid washout period), 120 days, 150 days, and 210 days. Multivariable models evaluated the effect of eliminating opioids on health-care expenditures at each of those times. RESULTS: Three hundred eighty-nine patients met inclusion criteria, and 51% completely eliminated systemic opioids (12% within the 30-day washout and an additional 39% by the end of the one-year horizon). Systemic opioid elimination within 120 to 210 days postimplant was associated with a reduction of $3,388 to $4,465 in inpatient and outpatient expenditures, and $4,689 to $5,571 in inpatient, outpatient, and drug expenditures. CONCLUSIONS: Fifty-one percent of patients completely eliminated systemic opioids in the year after IDDS implant. This elimination resulted in a 10% to 17% reduction in yearly inpatient, outpatient, and drug expenditures.

Comparative effectiveness of non-compounded polidocanol 1% endovenous microfoam (Varithena) ablation versus endovenous thermal ablation utilizing a systematic review and network meta-analysis.

OBJECTIVE: We compared the effectiveness and safety of polidocanol 1% endovenous microfoam ablation vs endovenous thermal ablation with radiofrequency or laser energy for treatment of venous insufficiency caused by lower extremity truncal vein incompetence via network meta-analysis of published comparative evidence. METHODS: We conducted a systematic literature review following best practices, including a prospective protocol. We screened studies published in English from 2000 to 2023 for randomized and nonrandomized studies reporting direct or indirect comparisons between polidocanol 1% endovenous microfoam and endovenous thermal ablation. Thirteen studies met our eligibility criteria for the network meta-analysis. The co-primary effectiveness outcomes were the closure rate ≥3 months after procedure and the average change in the Venous Clinical Severity Score. For the subgroup of venous ulcer patients, the ulcer healing rate was the primary effectiveness outcome. The secondary outcomes included safety and patient-reported outcomes. Network meta-analyses were conducted on outcomes having sufficient data. Categorical outcomes were summarized using odds ratios (ORs) with 95% confidence intervals (CIs). Sensitivity tests and estimates of network inconsistency were used to investigate the robustness of our meta-analysis. RESULTS: We found that polidocanol 1% endovenous microfoam was not significantly different statistically from endovenous thermal ablation for venous closure (OR, 0.65; 95% CI, 0.36-1.18; P = .16). Although not the primary aim of the study, the network meta-analysis also provided evidence to confirm our supposition that polidocanol 1% endovenous microfoam was significantly differentiated statistically from physician-compounded foam, with higher odds for vein closure (OR, 2.91; 95% CI, 1.58-5.37; P < .01). A sensitivity analysis using the longest available time point for closure in each study, with a minimum of 12 months of follow-up (median, 48 months; range, 12-72 months), showed results similar to those of the main analysis. No association was found between the risk of deep vein thrombosis and the treatment received. The available data were insufficient for a network meta-analysis of Venous Clinical Severity Score improvement and ulcer healing rates. CONCLUSIONS: Polidocanol 1% endovenous microfoam was not significantly different statistically from endovenous thermal ablation for venous closure and deep vein thrombosis risk for chronic venous insufficiency treatment, based on a network meta-analysis of published evidence. Polidocanol 1% endovenous microfoam was significantly differentiated statistically from physician-compounded foam, with higher odds of vein closure. A sensitivity analysis found venous closure findings were robust at follow-up intervals of 12 months or greater and for up to 6 years. New evidence meeting the inclusion criteria for this review will be incorporated at regular intervals into a living network meta-analysis.

Limited Access to Aortic Valve Procedures in Socioeconomically Disadvantaged Areas.

BACKGROUND: To explore how differences in local socioeconomic deprivation impact access to aortic valve procedures and the treatment of aortic valve disease, in comparison to other open and minimally invasive surgical procedures. METHODS AND RESULTS: Procedure volume data were obtained from the Healthcare Cost and Utilization Project from 18 states from 2016 to 2019 and merged with area deprivation index data, an index of zip code-level socioeconomic distress. We estimate the relationship between local deprivation ranking and differences in volumes of aortic valve replacement, which include transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR), versus coronary artery bypass graft surgery and laparoscopic colectomy (LC). All regressions control for state and year fixed effects and an array of zip code-level characteristics. TAVR procedures have increased over time across all zip codes. The rate of increase is negatively correlated with deprivation ranking, regardless of the higher share of hospitalizations per population in high deprivation areas. Distributional analysis further supports these findings, showing that lower area deprivation index areas account for a disproportionately large share of SAVR, TAVR, and LC procedures in our sample relative to their share of all hospitalizations in our sample. By comparison, the cumulative distribution of coronary artery bypass graft procedures was nearly identical to that of total hospitalizations, suggesting that this procedure is equitably distributed. Regressions show high area deprivation index areas have lower prevalence of SAVR (ß=-15.1%, [95% CI, -26.8 to -3.5]), TAVR (ß=-9.1%, [95% CI, -18.0 to -0.2]), and LC (ß=-19.9%, [95% CI, -35.4 to -4.4]), with no statistical difference in the prevalence of coronary artery bypass graft (ß=-2.5%, [95% CI, -12.7 to 7.6]), a widespread and commonly performed procedure. In the population aged ≥80 years, results show high area deprivation index areas have a lower prevalence of TAVR (ß=-11.9%, [95% CI, -18.7 to -5.2]) but not SAVR (ß=-0.8%, [95% CI, 8.1 to 6.3]), LC (ß=-3.5%, [95% CI, -13.4 to -6.4]), or coronary artery bypass graft (ß=5.2%, [95% CI, -1.1 to 1.1]). CONCLUSIONS: People living in high deprivation areas have less access to life-saving technologies, such as SAVR, and even moreso to device-intensive minimally invasive procedures such as TAVR and LC.

Economic measurement of medical errors using a hospital claims database.

OBJECTIVE: The primary objective of this study was to estimate the occurrence and costs of medical errors from the hospital perspective. METHODS: Methods from a recent actuarial study of medical errors were used to identify medical injuries. A visit qualified as an injury visit if at least 1 of 97 injury groupings occurred at that visit, and the percentage of injuries caused by medical error was estimated. Visits with more than four injuries were removed from the population to avoid overestimation of cost. Population estimates were extrapolated from the Premier hospital database to all US acute care hospitals. RESULTS: There were an estimated 161,655 medical errors in 2008 and 170,201 medical errors in 2009. Extrapolated to the entire US population, there were more than 4 million unique injury visits containing more than 1 million unique medical errors each year. This analysis estimated that the total annual cost of measurable medical errors in the United States was $985 million in 2008 and just over $1 billion in 2009. The median cost per error to hospitals was $892 for 2008 and rose to $939 in 2009. Nearly one third of all medical injuries were due to error in each year. CONCLUSIONS: Medical errors directly impact patient outcomes and hospitals' profitability, especially since 2008 when Medicare stopped reimbursing hospitals for care related to certain preventable medical errors. Hospitals must rigorously analyze causes of medical errors and implement comprehensive preventative programs to reduce their occurrence as the financial burden of medical errors shifts to hospitals.

Costs and clinical outcomes of conventional single port and micro-laparoscopic cholecystectomy.

BACKGROUND AND OBJECTIVE: This study compares hospital costs and clinical outcomes for conventional laparoscopic, single-port, and mini-laparoscopic cholecystectomy from US hospitals. METHODS: Eligible patients were aged ≥18 years and undergoing laparoscopic cholecystectomy with records in the Premier Hospital Database from 2009 through the second quarter of 2010. Patients were categorized into 3 groups-conventional laparoscopic, single port, or mini-laparoscopic-based on the International Classification of Diseases, Ninth Revision and Current Procedural Terminology codes and hospital charge descriptions for surgical tools used. A procedure was considered mini-laparoscopic if no single-port surgery products were identified in the charge master descriptions and the patient record showed that at least 1 product measuring 5 mm was used, not more than 1 product measuring <5 mm was used, and the measurements of the other products identified equaled >5 mm. Summary statistics were generated for all 3 groups. Multivariable analyses were performed on hospital costs and clinical outcomes. Models were adjusted for demographics, patient severity, comorbid conditions, and hospital characteristics. RESULTS: In the outpatient setting, for single-port surgery, hospital costs were approximately $834 more than those for mini-laparoscopic surgery and $964 more than those for conventional laparoscopic surgery (P < .0001). Adverse events were significantly higher (P < .0001) for single-port surgery compared with mini-laparoscopic surgery (95% confidence interval for odds ratio, 1.38-2.68) and single-port surgery versus conventional surgery (95% confidence interval for odds ratio, 1.37-2.35). Mini-laparoscopic surgery hospital costs were significantly (P < .0001) lower than the costs for conventional surgery by $211, and there were no significant differences in adverse events. CONCLUSIONS: These findings should inform practice patterns, treatment guidelines, and payor policy in managing cholecystectomy patients.

Healthcare utilization and expenditures in patients with atrial fibrillation treated with catheter ablation.

AIM: The aim was to estimate the impact of catheter ablation on short- and long-term healthcare utilization and expenditures among atrial fibrillation (AF) patients in general and Medicare populations. METHODS: Data were analyzed from The MarketScan(®) Databases. MarketScan data contain deidentified patient-level records from employer-sponsored and public health insurance plans. Multivariable regression models for utilization and expenditures were built for all patients, with subanalyses performed for patients ≥65 years. Results were compared to preablation figures and reported for 5 time groups, based on duration of available postablation follow-up: 6-12 months; 12-18 months; 18-24 months; 24-30 months; and 30-36 months. RESULTS: A total of 3,194 patients were identified who had undergone catheter ablation for treatment of AF, had continuous enrollment in the database 6 months prior to first ablation, and had at least 1-year follow-up postablation. Compared to the 6 months prior to ablation, there were significant reductions in the number of outpatient appointments, inpatient days, and emergency room visits in the total study population and in the subset ≥65 years. There was a statistically significant (P < 0.01) decrease in total healthcare expenditures across 4 of the 5 6-month time periods, with annual savings ranging from $3,300 to $9,200. For patients ≥65 years, annual savings ranged from $3,200 to $9,200. Drug utilization also significantly declined (P < 0.01), with average annual medication savings ranging from $670 to $890, and from $740 to $880 for patients ≥65 years. CONCLUSION: Catheter ablation for AF reduced healthcare utilization and expenditures up to 3 years postablation. This reduction was consistent, significant, and had implications for general and Medicare populations.

Direct health care insurer and out-of-pocket expenditures of inflammatory bowel disease: evidence from a US national survey.

BACKGROUND: Crohn's disease (CD) and ulcerative colitis (UC) are chronic, debilitating conditions that can have important economic and clinical implications. AIM: To quantify individual and national estimates of the health care and patient out-of-pocket (OOP) costs of CD and UC. METHODS: In a retrospective study using 1996 to 2009 data from the Medical Expenditure Panel Survey, individuals' self-reported health conditions were mapped to International Classification of Diseases, Ninth Revision, Clinical Modification diagnostic codes. Individuals with a code of 555.x (CD) or 556.x (UC) were identified. Health care services and costs included prescriptions and inpatient, outpatient, emergency room, office, and home health services. OOP costs were the portion of individuals' total payments for health care services. RESULTS: There were 358 individuals with CD (mean age 49.0 years; 55 % female), 198 individuals with UC (mean age 47.1 years; 64 % female), and 206,993 individuals without inflammatory bowel disease (IBD) (mean age 48.2 years; 58 % female). Annual per capita health insurer and OOP costs for individuals with CD were greater than those without IBD ($9,526 versus $3,781, p < 0.001 and $1,603 versus $866, p < 0.001, respectively). Health insurer and OOP costs were greater for UC compared with those without IBD ($6,443 versus $3,781, p < 0.001 and $1,263 versus $866, p < 0.001, respectively). US national aggregate annual estimates of health insurer, OOP, and total direct costs secondary to CD are $2.04 billion, $0.26 billion, and $2.29 billion, respectively. Aggregate health insurer, OOP, and total direct costs attributable to UC are $0.53 billion, $0.07 billion, and $0.61 billion, respectively. CONCLUSIONS: The direct costs associated with CD and UC are substantial. The extent to which appropriate diagnosis and treatment reduces the total health care costs for individuals with CD or UC should be examined.

Ultrasonography guidance reduces complications and costs associated with thoracentesis procedures.

PURPOSE.: We performed an analysis of hospitalizations involving thoracentesis procedures to determine whether the use of ultrasonographic (US) guidance is associated with differences in complications or hospital costs as compared with not using US guidance. METHODS.: We used the Premier hospital database to identify patients with ICD-9 coded thoracentesis in 2008. Use of US guidance was identified using CPT-4 codes. We performed univariate and multivariable analyses of cost data and adjusted for patient demographics, hospital characteristics, patient morbidity severity, and mortality. Logistic regression models were developed for pneumothorax and hemorrhage adverse events, controlling for patient demographics, morbidity severity, mortality, and hospital size. RESULTS.: Of 19,339 thoracentesis procedures, 46% were performed with US guidance. Mean total hospitalization costs were $11,786 (±$10,535) and $12,408 (±$13,157) for patients with and without US guidance, respectively (p < 0.001). Unadjusted risk of pneumothorax or hemorrhage was lower with US guidance (p = 0.019 and 0.078, respectively). Logistic regression analyses demonstrate that US is associated with a 16.3% reduction likelihood of pneumothorax (adjusted odds ratio 0.837, 95% CI: 0.73-0.96; p= 0.014), and 38.7% reduction in likelihood of hemorrhage (adjusted odds ratio 0.613, 95% CI: 0.36-1.04; p = 0.071). CONCLUSIONS.: US-guided thoracentesis is associated with lower total hospital stay costs and lower incidence of pneumothorax and hemorrhage. © 2011 Wiley Periodicals, Inc. J Clin Ultrasound, 2011.

The unintended consequences of Medicare's wage index adjustment on device-intensive hospital procedures.

OBJECTIVES: To study the association between Medicare's wage index adjustment and the differential use of labor-intensive surgical procedures and medical device-intensive minimally invasive clinical procedures across the United States. STUDY DESIGN: We combine a conceptual model and an empirical investigation of its predictions, applied to aortic valve replacement, to study the relationship between variation in Medicare wage index payment adjustment across hospital referral regions (HRRs) and the utilization of transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR) in these areas. METHODS: Using detailed individual Medicare claims data for 2013-2018 and a novel geographical crosswalk to nest information on Medicare's wage index and utilization of TAVR and SAVR, we estimate a mixed effects Poisson regression model across HRRs to test our hypotheses. RESULTS: We find regional variation in Medicare wage index adjustment levels to be correlated with differential TAVR and SAVR utilization and growth over time. In particular, in HRRs where the wage index is half the national mean there is a 35% decline in the rate of TAVR use and in HRRs where the wage index is 50% higher than the national mean there is a 52% increase in the rate of TAVR use. CONCLUSIONS: Consistent with our framework and hypothesis, our results highlight the importance of adjusting Medicare hospital inpatient payments for device-intensive procedures. Absent such adjustment, access to appropriate interventions may be reduced in areas with low wage index, and lower reimbursement, when driven by wage index adjustment, may influence the treatment approach selected.

Contemporary Costs Associated With Transcatheter Versus Surgical Aortic Valve Replacement in Medicare Beneficiaries.

BACKGROUND: In patients with severe aortic stenosis, treatment with transcatheter aortic valve replacement (TAVR) has been shown to be cost-effective in the high-risk surgical population and cost-saving in the intermediate-risk population when compared with surgical aortic valve replacement (SAVR) in early pivotal clinical trials. Whether TAVR is associated with comparable or lower costs when compared with SAVR in contemporary clinical practice is unknown. METHODS: Using data from the Medicare Dataset Standard Analytic Files 5% Fee for Service database, patients receiving either TAVR or SAVR between 2016 and 2018 were identified. Patients were categorized as low, intermediate, or high mortality risk based on 2 validated indices-the Hospital Frailty Risk Score and the logEuroScore. Health care costs out to 1 year were compared between TAVR and SAVR among the low, intermediate, and high-risk groups, after adjustment for patient demographics. RESULTS: Nine thousand seven hundred forty-six patients were identified (4834 TAVR; 3760 SAVR) and included in the analysis. Patients receiving TAVR were older and more likely to be female. Index hospitalization costs were significantly lower with TAVR compared with SAVR across all risk strata (logEuroScore: low: $61 845 versus $68 986; intermediate: $64 658 versus $76 965; high: $65 594 versus $91 005; P<0.001 for all). Follow-up costs through 1 year were generally lower with TAVR and this difference was more pronounced in the low risk groups (logEuroScore: $9763 versus $14 073; Hospital Frailty Risk Score: $10 116 versus $12 880). Accordingly, cumulative 1-year costs were substantially lower with TAVR compared with SAVR. CONCLUSIONS: At 1 year, TAVR is associated with lower health care costs across all risk strata when compared with SAVR in contemporary practice. If long-term data continue to demonstrate similar clinical outcomes and valve durability with TAVR and SAVR, these findings suggest that TAVR may be the preferred treatment strategy for patients with aortic stenosis from an economic standpoint.

Longitudinal outcomes in cryptogenic stroke patients with and without long-term cardiac monitoring for atrial fibrillation.

Background: Guidelines recommend a confirmed diagnosis of atrial fibrillation (AF) to initiate oral anticoagulation in cryptogenic stroke (CS) patients. However, the intermittent nature of AF can make detection challenging with intermittent short-term cardiac monitoring. Objective: The purpose of this retrospective cohort study was to examine post-CS utilization of cardiac monitoring and associated clinical outcomes. Methods: Adults with incident hospitalization for CS were identified in the Optum® claims database and assessed for cardiac monitoring received poststroke. Patient were stratified into those with a long-term insertable cardiac monitor (ICM) vs external cardiac monitor (ECM) only. The timing of ICM placement poststroke was treated as a time-dependent covariate. The clinical outcomes of interest were time to AF diagnosis, oral anticoagulation usage, and all-cause mortality. Results: A total of 12,994 patients met selection criteria for the analysis, of whom 1949 (15%) received an ICM and 11,045 (85%) received ECM only. In those who had received an ECM as their first monitoring modality, only 4.4% moved on to receive an ICM for longer-term monitoring. Use of ECM before ICM was associated with a longer time to AF diagnosis (median 336 vs 194 days). Compared to those with ECM only, ICM patients had a significantly lower rate of death (hazard ratio [HR] 0.70; P = .004), and faster time to AF diagnosis (HR 1.50; P <.0001) and anticoagulation initiation (HR 1.57; P <.0001) during follow-up of up to 5 years after CS. Conclusion: In a real-world study of CS patients, prolonged cardiac monitoring was associated with higher rates of AF detection and treatment, and higher odds of survival.

Anxiety and Depression Following Aortic Valve Replacement.

Background The aim of this study was to identify patients vulnerable for anxiety and/or depression following aortic valve replacement (AVR) and to evaluate factors that may mitigate this risk. Methods and Results This is a retrospective cohort study conducted using a claims database; 18 990 patients (1/2013-12/2018) ≥55 years of age with 6 months of pre-AVR data were identified. Anxiety and/or depression risk was compared at 3 months, 6 months, and 1 year following transcatheter aortic valve replacement or surgical AVR (SAVR) after risk adjustment using logistic regression and Cox proportional hazards models. Separate models were estimated for patients with and without surgical complications and discharge location. Patients with SAVR experienced a higher relative risk of anxiety and/or depression at 3 months (12.4% versus 8.8%; adjusted hazard ratio [HR] 1.39 [95% CI, 1.19-1.63]) and 6 months (15.6% versus 13.0%; adjusted HR, 1.24 [95% CI, 1.08-1.42]), with this difference narrowing by 12 months (20.1% versus 19.3%; adjusted HR, 1.14 [95% CI, 1.01-1.29]) after AVR. This association was most pronounced among patients discharged to home, with patients with SAVR having a higher relative risk of anxiety and/or depression. In patients who experienced operative complications, there was no difference between SAVR and transcatheter aortic valve replacement. However, among patients without operative complications, patients with SAVR had an increased risk of postoperative anxiety and/or depression at 3 months (adjusted HR, 1.47 [95% CI, 1.23-1.75]) and 6 months (adjusted HR 1.26 [95% CI, 1.08-1.46]), but not at 12 months. Conclusions There is an associated reduction in the risk of new-onset anxiety and/or depression among patients undergoing transcatheter aortic valve replacement (versus SAVR), particularly in the first 3 and 6 months following treatment.

Evaluating patient preferences for thermal ablation versus nonthermal, nontumescent varicose vein treatments.

OBJECTIVE: To measure patient preferences for attributes associated with thermal ablation and nonthermal, nontumescent varicose vein treatments. METHODS: Data were collected from an electronic patient preference survey taken by 70 adult participants (aged 20 years or older) at three Center for Vein Restoration clinics in New Jersey from July 19, 2019, through August 13, 2019. Survey participation was voluntary and anonymous (participation rate of 80.5% [70/87]). Patients were shown 10 consecutive screens that displayed three hypothetical treatment scenarios with different combinations of six attributes of interest and a none option. Choice-based conjoint analysis estimated the relative importance of different aspects of care, trade-offs between these aspects, and total satisfaction that respondents derived from different healthcare procedures. Market simulation analysis compared clusters of attributes mimicking thermal ablation and nonthermal, nontumescent treatments. RESULTS: Of the six attributes studied, out-of-pocket (OOP) expenditures were the most important to patients (37.2%), followed by postoperative discomfort (17.1%), risk of adverse events (16.3%), time to return to normal activity (11.0%), number of injections (10.0%), and number of visits (8.4%). Patients were willing to pay the most to avoid postoperative discomfort ($68.9) and risk of adverse events ($65.8). The market simulation analysis found that, regardless of the level of OOP spending, 60% to 80% of respondents favored attribute combinations corresponding with nonthermal, nontumescent procedures over thermal ablation, and that less than 1% of participants would forgo either treatment under no cost sharing. CONCLUSIONS: Patients are highly sensitive to OOP costs for minimally invasive varicose vein treatments. Market simulation analysis favored nonthermal, nontumescent procedures over thermal ablation.

Association of Iso-Osmolar vs Low-Osmolar Contrast Media With Major Adverse Renal or Cardiovascular Events in Patients at High Risk for Acute Kidney Injury Undergoing Endovascular Abdominal Aortic Aneurysm Repair.

OBJECTIVE: The purpose of this analysis was to examine the association of iso-osmolar contrast media (IOCM) vs low-osmolar contrast media (LOCM) with major adverse renal or cardiovascular events (MARCE) in patients at high risk of acute kidney injury (AKI), undergoing endovascular abdominal aortic aneurysm repair (EVAR). METHODS: Patients at high risk of AKI (defined as age ≥75 years, or one or more of the following comorbidities: diabetes, anemia, chronic kidney disease (CKD stages 1-4) or congestive heart failure), undergoing EVAR from September 2012 to June 2018 were identified using the Premier Hospital Database. We compared the primary endpoint of MARCE (composite of AKI, AKI requiring dialysis, acute myocardial infarction [AMI], stroke/transient ischemic attack [TIA], and death) with IOCM vs LOCM via adjusted multivariable regression analyses. RESULTS: Among 15,777 high-risk patients undergoing EVAR, the occurrence of in-hospital MARCE was 6.8%, including renal events (4.5%), AMI (0.8%), stroke/TIA (0.4%), and death (1.9%), IOCM was used in 7360 patients (47%). Multivariable modeling found IOCM was associated with 1.8% (95% confidence interval [CI], 0.4-3.3; P=.01) lower absolute risk for MARCE (23.9% relative risk reduction; 95% CI, 5.2%-44.2%). CONCLUSIONS: Use of IOCM vs LOCM in patients at high risk of AKI undergoing EVAR procedures was associated with a lower risk of MARCE. As prevention of AKI or cardiovascular events after EVAR procedures may lead to reduced morbidity and mortality, this finding may have important clinical implications and should be confirmed through randomized controlled clinical studies.

Long-term Healthcare Expenditures Over Time for Tissue and Mechanical Aortic Valve Replacement.

BACKGROUND: Guidelines currently indicate the use of surgical aortic valve replacement (SAVR) to treat severe cases of aortic stenosis, particularly for low- to medium-risk patients. Although several studies have compared health outcomes of tissue and mechanical SAVR, this economic simulation model estimates the difference in long-term healthcare costs associated with tissue relative to mechanical SAVR. METHODS: The deterministic and Monte Carlo simulation models used literature-based epidemiologic and cost inputs to calculate annual expenditures related to SAVR for up to 25 years after initial surgery. A series of 3 cohort studies across different age groups provided the health outcome probabilities for tissue valve patients. Outcome probabilities for mechanical valve patients were based on relative risks reported in comparative meta-analyses or large cohort studies. RESULTS: Relative to mechanical SAVR the expected net discounted savings for a patient receiving tissue SAVR at ages 45, 55, and 65 years were $12,266, $15,462, and $16,008, respectively (based on 2018 US dollars) over a 25-year horizon (95% confidence intervals exceed $0). For a 45-year-old tissue SAVR patient, the estimated per-patient cost difference (relative to mechanical SAVR) of reoperation over 25 years ($16,201) were offset by expected savings on anticoagulation monitoring ($26,257) over the same period. In a sensitivity analysis in which mortality risk was assumed equal, significant long-term savings associated with tissue SAVR still accrued in each of the 3 age cohorts. CONCLUSIONS: Payers, providers, and the healthcare system may financially benefit from the use of tissue valves because significant savings were associated with the use of tissue valves relative to mechanical valves for SAVR.

Healthcare utilization and guideline-directed medical therapy in heart failure patients with reduced ejection fraction.

Aim: This study examines the effect of guideline-directed medical therapy (GDMT) on healthcare utilization in patients with heart failure with reduced ejection fraction from Optum® Integrated File from 1 January 2007 to 30 June 2020. Materials & methods: Patients with both a beta blocker and either an ACE inhibitor (ACE-I), angiotensin receptor blocker (ARB) or angiotensin receptor neprilysin inhibitor were assigned to the GDMT cohort. All others were not on GDMT. Results: Estimated annual all cause hospitalizations and emergency department visits per 100 patients was 29% (80 vs 62 patients) and 26% higher (54 vs 43 patients; p < 0.0001) and annualized hospital days were longer (1.88 vs 1.64; p = 0.0020) for patients not on GDMT. Conclusion: In a real-world population, heart failure with reduced ejection fraction, patients not optimally managed on GDMT had higher annualized healthcare utilization when compared with patients on GDMT.