Comparison of Transcatheter Edge-to-Edge Mitral Valve Repair for Primary Mitral Regurgitation Outcomes to Hospital Volumes of Surgical Mitral Valve Repair.

BACKGROUND: Transcatheter edge-to-edge mitral valve (MV) repair (TEER) is an effective treatment for patients with primary mitral regurgitation at prohibitive risk for surgical MV repair (MVr). High-volume MVr centers and high-volume TEER centers have better outcomes than low-volume centers, respectively. However, whether MVr volume predicts TEER outcomes remains unknown. We hypothesized that high-volume MV surgical centers would have superior risk-adjusted outcomes for TEER than low-volume centers. METHODS: We combined data from the American College of Cardiology/Society of Thoracic Surgeons Transcatheter Valve Therapy registry and the Society of Thoracic Surgeons adult cardiac surgery database. MVr was defined as leaflet resection or artificial chords with or without annuloplasty and was evaluated as a continuous variable and as predefined categories (<25, 25-49, and ≥50 MV repairs/year). A generalized linear mixed model was used to evaluate risk-adjusted in-hospital/30-day mortality, 30-day heart failure readmission, and TEER success (mitral regurgitation ≤2+ and gradient <5 mm Hg). RESULTS: The study comprised 41 834 patients from 500 sites of which 332 (66.4%) were low, 102 (20.4%) intermediate, and 66 (13.2%) high-volume surgical centers (P<0.001). TEER success was 54.6% and was not statistically significantly different across MV surgical site volumes (P=0.4271). TEER mortality at 30 days was 3.5% with no significant difference across MVr volume on unadjusted (P=0.141) or adjusted (P=0.071) analysis of volume as a continuous variable. One-year mortality was 15.0% and was lower for higher MVr volume centers when adjusted for clinical and demographic variables (P=0.027). Heart failure readmission at 1 year was 9.4% and was statistically significantly lower in high-volume centers on both unadjusted (P=0.017) or adjusted (P=0.015) analysis. CONCLUSIONS: TEER can be safely performed in centers with low volumes of MV repair. However, 1-year mortality and heart failure readmission are superior at centers with higher MVr volume.

National Variation in Hospital MTEER Outcomes and Correlation With TAVR Outcomes: STS/ACC TVT Registry Analysis.

BACKGROUND: A single, multitiered valve center designation has been proposed to publicly identify centers with expertise for all valve therapies. The correlation between transcatheter aortic valve replacement (TAVR) and mitral transcatheter edge-to-edge repair (MTEER) procedures is unknown. OBJECTIVES: The authors sought to examine the relationship between site-level volumes and outcomes for TAVR and MTEER. We further explored variability between sites for MTEER outcomes. METHODS: Using the STS/ACC TVT (Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy) national registry, TAVR and MTEER procedures at sites offering both therapies from 2013 to 2022 were examined. Sites were ranked into deciles of adjusted in-hospital and 30-day outcomes separately for TAVR and MTEER and compared. Stepwise, hierarchical multivariable models were constructed for MTEER outcomes, and the median OR was calculated. RESULTS: Between 2013 and 2022, 384,394 TAVRs and 53,274 MTEERs (median annualized volumes: 93.6 and 18.8, respectively) were performed across 453 U.S. sites. Annualized TAVR and MTEER volumes were moderately correlated (r = 0.48; P < 0.001). After adjustment, 14.3% of sites had the same decile rank for TAVR and MTEER 30-day composite outcome, 50.6% were within 2 decile ranks; 35% had more discordant outcomes for the 2 procedures (P = 0.0005). For MTEER procedures, the median OR for the 30-day composite outcome was 1.57 (95% CI: 1.51-1.64), indicating a 57% variability in outcome by site. CONCLUSIONS: There is modest correlation between hospital-level volumes for TAVR and MTEER but low interprocedural correlation of outcomes. For similar patients, site-level variability for mortality/morbidity following MTEER was high. Factors influencing outcomes and "centers of excellence" as a whole may differ for TAVR and MTEER.

National Variability in Pacemaker Implantation Rate Following TAVR: Insights From the STS/ACC TVT Registry.

BACKGROUND: Although permanent pacemaker (PPM) implantation is a common complication of transcatheter aortic valve replacement (TAVR), hospital variation and change in PPM implantation rates are ill defined. OBJECTIVES: The aim of this study was to determine hospital-level variation and temporal trends in the rate of PPM implantation following TAVR. METHODS: Using the American College of Cardiology/Society of Thoracic Surgeons TVT (Transcatheter Valve Therapy) Registry, temporal changes in variation of in-hospital and 30-day PPM implantation were determined among 184,452 TAVR procedures across 653 sites performed from 2016 to 2020. The variation in PPM implantation adjusted for valve type by annualized TAVR volume was determined, and characteristics of sites below, within, and above the 95% boundary were identified. A series of stepwise multivariable hierarchical models were then fit, and the median OR was used to measure variation in pacemaker rates among sites. RESULTS: From 2016 to 2020, the overall rate of PPM implantation was 11.3%, with wide variation across sites (range: 0%-36.4%); rates trended lower over time. Adjusted for annualized volume, there were 34 sites with PPM implantation rates above the 95th percentile CI and 28 with rates below, with wide variation among the remaining sites. After adjusting for patient-level covariates, there was variation among sites in the probability of PPM implantation (median OR: 1.39; 95% CI: 1.35-1.43, P < 0.001); although some of the variation was explained by the addition of valve type, residual variation in PPM implantation rates persisted in additional models incorporating site-level covariates (annualized volume, region, teaching status, hospital beds, etc). CONCLUSIONS: Although PPM implantation rates have decreased over time, substantial site-level variation remains even after accounting for observed patient characteristics and site-level factors. As there are numerous outlier sites both above and below the 95% confidence limit, dissemination of best practices from high-performing sites to low-performing sites and guideline-based education may be important quality improvement initiatives to reduce rates of this common complication.

Outcomes of Transcatheter Aortic Valve Replacement in Asymptomatic or Minimally Symptomatic Aortic Stenosis.

BACKGROUND: Little is known about the outcomes of transcatheter aortic valve replacement (TAVR) in minimally symptomatic patients. OBJECTIVES: The authors aimed to evaluate the outcomes of patients with minimally symptomatic severe aortic stenosis treated with TAVR in the STS/ACC TVT registry. METHODS: Minimally symptomatic status was defined as a baseline Kansas City Cardiomyopathy Questionnaire overall summary score (KCCQ-OS) ≥75. Clinical and health status outcomes of TAVR in patients with severe aortic stenosis and normal left ventricular ejection fraction were compared between minimally symptomatic patients and those with moderate or severe symptoms. RESULTS: Among 231,285 patients who underwent TAVR between 2015 and 2021 (median age 80.0 years [IQR: 74.0-86.0 years], 47.5% female), 20.0% were minimally symptomatic before TAVR. Survival at 1 year was higher in minimally symptomatic patients vs those with moderate or severe symptoms (adjusted HR for death: 0.70 [95% CI: 0.66-0.75]). Mean KCCQ-OS increased by 2.7 points (95% CI: 2.6-2.9 points) at 30 days and 3.8 points (95% CI: 3.6-4.0 points) at 1 year in minimally symptomatic patients compared with increases of 32.2 points (95% CI: 32.0-32.3 points) at 30 days and 34.9 points (95% CI: 34.7-35.0 points) at 1 year in more symptomatic patients. Minimally symptomatic patients had higher odds of being alive and well at 1 year (OR: 1.19 [95% CI: 1.16-1.23]). CONCLUSIONS: Although minimally symptomatic patients treated with TAVR experience only small improvements in health status, their overall outcomes are favorable with a higher likelihood of survival with good health status at 1 year compared with more symptomatic patients.

Outcomes and Institutional Variation in Arterial Access Among Patients With AMI and Cardiogenic Shock Undergoing PCI.

BACKGROUND: Contemporary data comparing the outcomes of transradial access (TRA) vs transfemoral access (TFA) among patients presenting with acute myocardial infarction and cardiogenic shock (AMI-CS) undergoing percutaneous coronary intervention (PCI) are limited. OBJECTIVES: This study examines in-hospital outcomes and institutional variation among patients with AMI-CS undergoing TRA-PCI vs TFA-PCI. METHODS: Patients admitted with AMI-CS from the NCDR CathPCI registry between April 2018 and June 2021 were included. Multivariable logistic regression and inverse probability weighting models were used to assess the association between access site and in-hospital outcomes. A falsification analysis using non-access site-related bleeding was performed. RESULTS: Among 35,944 patients with AMI-CS undergoing PCI, 25.6% were performed with TRA. The proportion of TRA-PCI increased over the study period (22.0% in the second quarter of 2018 vs 29.1% in the second quarter of 2021; P-trend <0.001). Significant institutional-level variability in the use of TRA-PCI was also observed: 20.9% of all sites using TRA in <2% of PCIs (low utilization) vs 1.9% of all sites using TRA in >80% of PCIs (high utilization). Patients undergoing TRA-PCI had a significantly lower adjusted incidence of major bleeding (odds ratio [OR]: 0.71; 95% confidence interval [CI]: 0.67-0.76), mortality (OR: 0.73; 95% CI: 0.69-0.78), vascular complications (OR: 0.67; 95% CI: 0.54-0.84), and new dialysis (OR: 0.86; 95% CI: 0.77-0.97). There was no difference in non-access site related bleeding (OR: 0.93; 95% CI: 0.84-1.03). Sensitivity analyses revealed similar benefit with TRA-PCI among patients without arterial cross-over. There were no significant interactions observed between TRA-PCI with mechanical circulatory support and in-hospital outcomes. CONCLUSIONS: In this large nationwide contemporary analysis of patients with AMI-CS, about quarter of PCIs were performed via TRA with wide variability across US institutions. TRA-PCI was associated with significantly lower incidence of in-hospital major bleeding, mortality, vascular complications, and new dialysis. This benefit was observed irrespective of mechanical circulatory support use.

Mediators of Improvement in TAVR Outcomes Over Time: Insights From the STS-ACC TVT Registry.

BACKGROUND: Over the past decade, there has been substantial improvement in outcomes after transcatheter aortic valve replacement. Many patient and procedural factors have also changed over that time, making it challenging to untangle the drivers of those improvements. METHODS: Among patients who underwent transcatheter aortic valve replacement from 2012 to 2018 within the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapies Registry, we examined the relative contribution of changes in patient factors, device modifications, improving experience/skill, and advances in periprocedural care to the observed improvement in outcomes after transcatheter aortic valve replacement. Mediator clusters included demographics, noncardiovascular comorbidities, cardiovascular comorbidities, device-related factors, and nondevice-related procedural factors. Using logistic regression, we serially adjusted for the mediator clusters to examine the contribution of each to the observed improvement in outcomes over time. RESULTS: Among 161 196 patients treated with transcatheter aortic valve replacement at 596 sites, outcomes improved steadily from 2012 to 2018, including 30-day mortality (6.7% to 2.4%), 30-day composite adverse events (25.3% to 10.5%), and 1-year mortality (19.9% to 10.1%; all P<0.001). In sequential models, the unadjusted odds ratio for 30-day mortality was 0.82 per year (95% CI, 0.80-0.84), which was progressively attenuated with addition of each covariate cluster. Most of the improvement was explained by device factors and nondevice procedural factors. Results were similar for 30-day composite adverse events, although the observed temporal improvement was not fully explained by measured factors, suggesting improved technical skill as an additional mediator. In contrast to 30-day outcomes, each cluster of patient and procedural factors contributed similarly to the temporal improvement in 1-year mortality, indicating a greater impact of patient factors on longer-term outcomes. CONCLUSIONS: While US patients undergoing transcatheter aortic valve replacement have become younger, healthier, and lower risk over time, the most important factors contributing to improvements in short-term outcomes relate to advances in device technology and procedural factors, whereas changing patient characteristics had a greater impact on improvement in 1-year outcomes.

Association of Transcatheter Aortic Valve Replacement Reimbursement, New Technology Add-on Payment, and Procedure Volumes With Embolic Protection Device Use.

Importance: In the setting of uncertain efficacy and additional, unreimbursed cost, use of an embolic protection device (EPD) during transcatheter aortic valve replacement (TAVR) has had variable uptake. The Centers for Medicare & Medicaid Services (CMS) instituted a new technology add-on payment to cover EPD use in October 2018. Objective: To evaluate the association between CMS TAVR reimbursement rates and EPD use. Design, Setting, and Participants: This cohort study used the Society for Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy registry to identify patients who underwent TAVR between January 2018 and September 2019. Analysis took place between July 2020 and February 2022. Main Outcomes and Measures: The association between EPD use and CMS reimbursement was assessed using multivariable logistic regression models adjusted for patient characteristics (model 1) and patient/hospital (annualized TAVR volume and teaching status) characteristics (model 2). Results: Among 511 institutions, CMS reimbursement for TAVR ranged from $28 062 to $111 280 with a median (IQR) of $45 884 ($40 331-$53 627). Among 84 353 patients (median [IQR] age, 81.0 [75.0-86.0] years; 46 247 male individuals [54.8%]; 3958 [4.7%] of Hispanic or Latino ethnicity; 78 170 White individuals [92.7%]) treated at the sites, 6012 (7.1%) underwent TAVR with EPD. Patient characteristics associated with EPD use included prior stroke (adjusted odds ratio [aOR], 1.13 [95% CI, 1.00-1.27]; P = .048), female sex (aOR, 0.85 [95% CI, 0.78-0.93]; P < .001), hemodialysis (aOR, 0.52 [95% CI, 0.40-0.68]; P < .001), and shock (aOR, 0.62 [95% CI, 0.41-0.94]; P = .03). Higher CMS reimbursement up to $50 000 per TAVR was associated with greater likelihood of EPD use in model 1 (per $1000; aOR, 1.08 [95% CI, 1.01-1.16]; P = .02). However, this association was no longer apparent after adjusting for site characteristics (model 2; aOR, 1.03 [95% CI, 0.96-1.11]; P = .38). Higher TAVR volume was associated with increased EPD use (per 25 TAVRs; aOR, 1.15 [95% CI, 1.09-1.21]; P < .001). There was no significant change in the odds of EPD uptake before vs after institution of the CMS new technology add-on payment across tertiles of CMS TAVR reimbursement (Wald χ2 = 3.59; P = .17). Conclusions and Relevance: EPD use during TAVR remains infrequent and is associated with multiple patient and site characteristics. While CMS reimbursement varies significantly across institutions, TAVR case volume, rather than CMS TAVR reimbursement or the CMS new technology add-on payment, appears to be the predominant factor associated with EPD use. Ongoing work is needed to understand the economic drivers that contribute to the association between procedural volume and EPD use.

Untapped Potential for Emergency Department Observation Unit Use: A National Hospital Ambulatory Medical Care Survey (NHAMCS) Study.

INTRODUCTION: Millions of people present to the emergency department (ED) with chest pain annually. Accurate and timely risk stratification is important to identify potentially life-threatening conditions such as acute coronary syndrome (ACS). An ED-based observation unit can be used to rapidly evaluate patients and reduce ED crowding, but the practice is not universal. We estimated the number of current hospital admissions in the United States (US) eligible for ED-based observation services for patients with symptoms of ACS. METHODS: In this cross-sectional analysis we used data from the 2011-2015 National Hospital Ambulatory Medical Care Survey (NHAMCS). Visits were included if patients presented with symptoms of ACS (eg, chest pain, dyspnea), had an electrocardiogram (ECG) and cardiac markers, and were admitted to the hospital. We excluded patients with any of the following: discharge diagnosis of myocardial infarction; cardiac arrest; congestive heart failure, or unstable angina; admission to an intensive care unit; hospital length of stay > 2 days; alteplase administration, central venous catheter insertion, cardiopulmonary resuscitation or endotracheal intubation; or admission after an initial ED observation stay. We extracted data on sociodemographics, hospital characteristics, triage level, disposition from the ED, and year of ED extracted from the NHAMCS. Descriptive statistics were performed using sampling weights to produce national estimates of ED visits. We provide medians with interquartile ranges for continuous variables and percentages with 95% confidence intervals for categorical variables. RESULTS: During 2011-2015 there were an estimated 675,883,000 ED visits in the US. Of these, 14,353,000 patients with symptoms of ACS and an ED order for an ECG or cardiac markers were admitted to the hospital. We identified 1,883,000 visits that were amenable to ED observation services, where 987,000 (52.4%) were male patients, and 1,318,000 (70%) were White. Further-more, 739,000 (39.2%) and 234,000 (12.4%) were paid for by Medicare and Medicaid, respectively. The majority (45.1%) of observation-amenable hospitalizations were in the Southern US. CONCLUSION: Emergency department-based observation unit services for suspected ACS appear to be underused. Over half of potentially observation-amenable admissions were paid for by Medicare and Medicaid. Implementation of ED-based observation units would especially benefit hospitals and patients in the American South.

Percutaneous Coronary Intervention Following Diagnostic Angiography by Noninterventional Versus Interventional Cardiologists: Insights From the CathPCI Registry.

BACKGROUND: There are limited contemporary, national data describing diagnostic cardiac catheterization with subsequent percutaneous coronary intervention (ad hoc percutaneous coronary intervention [PCI]) performed by an invasive-diagnostic and interventional (Dx/IC) operator team versus solo interventional operator (solo-IC). Using the CathPCI Registry, this study aimed at analyzing trends and outcomes in ad hoc PCI among Dx/IC versus solo-IC operators. METHODS: Quarterly rates (January 2012 to March 2018) of ad hoc PCI cases by Dx/IC and solo-IC operators were obtained. Odds of inhospital major adverse cardiovascular events, net adverse cardiovascular events (ie, composite major adverse cardiovascular event+bleeding), and rarely appropriate PCI were estimated using multivariable regression. RESULTS: From 1077 sites, 1 262 948 patients were included. The number of invasive-diagnostic operators and cases performed by Dx/IC teams decreased from nearly 9% to 5% during the study period. Patients treated by Dx/IC teams were more often White and had fewer comorbidities compared with patients treated by solo-IC operators. Considerable variation existed across sites, and over two-fifths of sites had 0% ad hoc PCI performed by Dx/IC. In adjusted analyses, ad hoc performed by Dx/IC had similar risks of major adverse cardiovascular event (OR, 1.04 [95% CI, 0.97-1.11]) and net adverse cardiovascular events (OR, 0.98 [95% CI, 0.94-1.03]) compared with solo-IC. Rarely appropriate PCI, although low overall (2.1% versus 1.9%) occurred more often by Dx/IC compared with solo-IC (OR, 1.20 [95% CI, 1.13-1.26]). CONCLUSIONS: Contemporary, nationwide data from the CathPCI Registry demonstrates the number of Dx/IC operator teams and cases has decreased but that case volume is stable among operators. Outcomes were independent of operator type, which supports current practice patterns. The finding of a higher risk of rarely appropriate PCI in Dx/IC teams should be further studied.

Transcatheter Mitral Valve Therapy in the United States: A Report from the STS/ACC TVT Registry.

Data for nearly all patients undergoing transcatheter edge-to-edge repair (TEER) and transcatheter mitral valve replacement (TMVR) with an approved device in the United States is captured in the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry. All data submitted for TEER or TMVR between 2014 and March 31, 2020, are reported. A total of 37,475 patients underwent a mitral transcatheter procedure, including 33,878 TEER and 3,597 TMVR. Annual procedure volumes for TEER have increased from 1,152 per year in 2014 to 10,460 per year in 2019 at 403 sites and for TMVR from 84 per year to 1,120 per year at 301 centers. Mortality rates have decreased for TEER at 30 days (5.6%-4.1%) and 1 year (27.4%-22.0%). Early off-label use data on TMVR in mitral valve-in-valve therapy led to approval by the U.S. Food and Drug Administration in 2017, and the 2019 30-day mortality rate was 3.9%. Overall improvements in outcomes over the last 6 years are apparent. (STS/ACC TVT Registry Mitral Module; NCT02245763).

Patient-reported vs. physician-estimated symptoms before and after transcatheter aortic valve replacement.

AIMS: In contrast to patient-reported health status measures (such as the Kansas City Cardiomyopathy Questionnaire), the New York Heart Association class is based on a physician's assessment of heart failure symptoms and functional limitations on behalf of the patient. We sought to determine the concordance and predictors of physician under- and overestimation of symptoms prior to and after transcatheter aortic valve replacement (TAVR). METHODS AND RESULTS: The analytic cohort included 172 667 patients within the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry who underwent transfemoral TAVR. At baseline, physicians underestimated patients' symptoms in 47.4%, correctly assessed symptoms in 26.6%, and overestimated symptoms in 26.0%. At 30 days after TAVR, these proportions were 22.8%, 50.3%, and 26.9%, respectively. Using nominal logistic regression with random intercepts to account for within-hospital clustering, we found that physicians were more likely to incorrectly estimate patients' symptoms when patients were older, women, had a prior stroke, had severe lung disease, had atrial fibrillation, or were more obese. There was marked variability in the rates of underestimation, correct estimation, and overestimation across the 641 sites. CONCLUSION: Among patients undergoing treatment for severe aortic stenosis, physicians estimate patients' symptoms and functional status poorly both prior to and after TAVR, with different patterns. These findings emphasize the need to collect patient-reported health status to more reliably assess the benefits of TAVR in routine clinical practice.

United States Emergency Department Use of Medications with Pharmacogenetic Recommendations.

INTRODUCTION: Emergency departments (ED) use many medications with a range of therapeutic efficacy and potential significant side effects, and many medications have dosage adjustment recommendations based on the patient's specific genotype. How frequently medications with such pharmaco-genetic recommendations are used in United States (US) EDs has not been studied. METHODS: We conducted a cross-sectional analysis of the 2010-2015 National Hospital Ambulatory Medical Care Survey (NHAMCS). We reported the proportion of ED visits in which at least one medication with Clinical Pharmacogenetics Implementation Consortium (CPIC) recommendation of Level A or B evidence was ordered. Secondary comparisons included distributions and 95% confidence intervals of age, gender, race/ethnicity, ED disposition, geographical region, immediacy, and insurance status between all ED visits and those involving a CPIC medication. RESULTS: From 165,155 entries representing 805,726,000 US ED visits in the 2010-2015 NHAMCS, 148,243,000 ED visits (18.4%) led to orders of CPIC medications. The most common CPIC medication was tramadol (6.3%). Visits involving CPIC medications had higher proportions of patients who were female, had private insurance and self-pay, and were discharged from the ED. They also involved lower proportions of patients with Medicare and Medicaid. CONCLUSION: Almost one fifth of US ED visits involve a medication with a pharmacogenetic recommendation that may impact the efficacy and toxicity for individual patients. While direct application of genotyping is still in development, it is important for emergency care providers to understand and support this technology given its potential to improve individualized, patient-centered care.

Transcatheter Mitral Valve Therapy in the United States: A Report From the STS-ACC TVT Registry.

Data for nearly all patients undergoing transcatheter edge-to-edge repair (TEER) and transcatheter mitral valve replacement (TMVR) with an approved device in the United States is captured in the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry. All data submitted for TEER or TMVR between 2014 and March 31, 2020, are reported. A total of 37,475 patients underwent a mitral transcatheter procedure, including 33,878 TEER and 3,597 TMVR. Annual procedure volumes for TEER have increased from 1,152 per year in 2014 to 10,460 per year in 2019 at 403 sites and for TMVR from 84 per year to 1,120 per year at 301 centers. Mortality rates have decreased for TEER at 30 days (5.6%-4.1%) and 1 year (27.4%-22.0%). Early off-label use data on TMVR in mitral valve-in-valve therapy led to approval by the U.S. Food and Drug Administration in 2017, and the 2019 30-day mortality rate was 3.9%. Overall improvements in outcomes over the last 6 years are apparent. (STS/ACC TVT Registry Mitral Module; NCT02245763).

Composite Metric for Benchmarking Site Performance in Transcatheter Aortic Valve Replacement: Results From the STS/ACC TVT Registry.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) is a transformative therapy for aortic stenosis. Despite rapid improvements in technology and techniques, serious complications remain relatively common and are not well described by single outcome measures. The purpose of this study was to determine whether there is site-level variation in TAVR outcomes in the United States using a novel 30-day composite measure. METHODS: We performed a retrospective cohort study using data from the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapies Registry to develop a novel ranked composite performance measure that incorporates mortality and serious complications. The selection and rank order of the complications for the composite was determined by their adjusted association with 1-year outcomes. Sites with risk-adjusted outcomes significantly more or less frequent than the national average based on a 95% probability interval were classified as performing worse or better than expected. RESULTS: The development cohort consisted of 52 561 patients who underwent TAVR between January 1, 2015, and December 31, 2017. Based on associations with 1-year risk-adjusted mortality and health status, we identified 4 periprocedural complications to include in the composite risk model in addition to mortality. Ranked empirically according to severity, these included stroke, major, life-threatening or disabling bleeding, stage III acute kidney injury, and moderate or severe perivalvular regurgitation. Based on these ranked outcomes, we found that there was significant site-level variation in quality of care in TAVR in the United States. Overall, better than expected site performance was observed in 25/301 (8%) sites, performance as expected was observed in 242/301 sites (80%), and worse than expected performance was observed in 34/301 (11%) sites. Thirty-day mortality; stroke; major, life-threatening, or disabling bleeding; and moderate or severe perivalvular leak were each substantially more common in sites with worse than expected performance as compared with other sites. There was good aggregate reliability of the model. CONCLUSIONS: There are substantial variations in the quality of TAVR care received in the United States and 11% of sites were identified as providing care below the average level of performance. Further study is necessary to determine structural, process-related, and technical factors associated with high- and low-performing sites.

Higher daily pain severity after emergency department visits is associated with lower return-to-work rates.

BACKGROUND: Pain can impair functional status, including a patient's ability to return to work. The purpose of this study was to determine whether there was an association between pain levels and return-to-work status during the first 4 days post-ED discharge in ED patients seen for undifferentiated acute pain. METHODS: This secondary analysis of data from the Acute Management of Pain from the Emergency Department (AMPED) registry included patients who reported working either full-time or part-time. We used Cox regression models to examine the association between daily self-reported minimum and maximum pain scores and first return to work. We used repeated measures logistic regression models to examine the association between daily minimum and maximum pain scores and daily return-to-work status. RESULTS: Of the 610 employed patients, 481 (78.9%) were employed full-time and 129 (21.1%) part-time. The average delay in returning to work after ED visit was 2.4 days. For all models, higher minimum and maximum daily pain scores predicted lower daily return-to-work rates in the first four days post-ED discharge. The adjusted hazards ratios for first return to work were 0.91 (0.87, 0.96) and 0.93 (0.89, 0.97), while the adjusted odds ratios for daily return-to-work status were 0.80 (0.75, 0.85) and 0.88 (0.83, 0.93) for every one-point increase in minimum and maximum pain scores, respectively. CONCLUSION: Higher daily pain severity is associated with decreased return-to-work after ED visits for acute pain, highlighting the importance of adequate discharge pain management from the ED.

Practical Application of Patient-Reported Health Status Measures for Transcatheter Valve Therapies: Insights From the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapies Registry.

BACKGROUND: Health status assessment is essential for documenting the benefit of transcatheter aortic valve replacement (TAVR) or transcatheter mitral valve repair on patients' symptoms, function, and quality of life. Health status can also be a powerful marker for subsequent clinical outcomes, but its prognostic importance around the time of both TAVR and transcatheter mitral valve repair has not been fully defined. METHODS: Among 73 699 patients who underwent transfemoral TAVR or transcatheter mitral valve repair between 2011 and 2018 (mean age, 81.9±7.0 years, 53% men, 92% TAVR), we constructed sequential models examining the association of health status (as assessed with the Kansas City Cardiomyopathy Questionnaire-Overall Summary Score; KCCQ-OS) at baseline, 30 days, change from baseline to 30 days, and combinations of these assessments with death and heart failure (HF) hospitalization from 30 days to 1 year. RESULTS: Although higher baseline KCCQ-OS and 30-day KCCQ-OS scores were each associated with lower risk of death and HF hospitalization (in individual models and in a model including both measures), the 30-day KCCQ-OS was most predictive (death: hazard ratio, 0.89 per 5-point increase [95% CI, 0.89-0.90]; HF hospitalization: hazard ratio, 0.91 [95% CI, 0.90-0.91]). The 30-day KCCQ-OS also was most predictive when included in a separate model with change in KCCQ from baseline to 30 days. Similar findings were noted for the outcomes of death and of HF hospitalization, unadjusted and adjusted for patient factors. All interaction terms between procedure type and KCCQ were not significant, suggesting that health status provided similar prognostic information in both procedures. CONCLUSIONS: The patient's assessment of their health status immediately before and 30 days after TAVR and transcatheter mitral valve repair is associated with subsequent risk of death and HF hospitalization, with the 30-day assessment being most strongly associated with outcomes. Our findings support the routine use of KCCQ data as a prognostic tool.

Impact of short-term complications of transcatheter aortic valve replacement on longer-term outcomes: results from the STS/ACC Transcatheter Valve Therapy Registry.

AIMS: While complications of transcatheter aortic valve replacement (TAVR) have decreased, they still occur commonly and may negatively impact both short- and long-term outcomes. We sought to examine the association of complications after TAVR with survival and health status in a real-world cohort. METHODS AND RESULTS: Among 45 884 TAVR patients from 513 US sites who survived 30 days, 21.4% had at least one major complication [stroke, bleed, vascular complication, new pacemaker, acute kidney injury (AKI), and moderate/severe paravalvular leak (PVL)]. In multivariable models, Stage 3 AKI [hazard ratio (HR) 3.43, 95% confidence interval (CI) 2.64-4.45], stroke (HR 2.62, 95% CI 2.06-3.32), and bleeding (HR 1.83, 95% CI 1.55-2.16) were independently associated with significantly increased risk of early death (<3 months) with slight attenuation in these hazards between 3 and 12 months. Moderate/severe PVL (HR 1.37, 95% CI 1.21-1.55) and new pacemaker (HR 1.15, 95% CI 1.05-1.25) were associated with more modest risk of excess mortality that was consistent through 12 months. Among surviving patients, stroke (-6.1 points, 95% CI -8.4 to -3.7), moderate/severe PVL (-3.2 points, 95% CI -4.9 to -1.6), and new pacemaker (-2.3 points, 95% CI -3.2 to -1.5) were associated with less improvement in 1-year health status, as assessed by the Kansas City Cardiomyopathy Questionnaire. CONCLUSION: In this study of contemporary TAVR, we found that complications remain common within the first 30 days after TAVR and are associated with worse 1-year survival and health status among survivors. These findings support continued efforts to reduce major complications of TAVR and may also help define quality of care.

A Method for Grouping Emergency Department Visits by Severity and Complexity.

INTRODUCTION: Triage functions to quickly prioritize care and sort patients by anticipated resource needs. Despite widespread use of the Emergency Severity Index (ESI), there is still no universal standard for emergency department (ED) triage. Thus, it can be difficult to objectively assess national trends in ED acuity and resource requirements. We sought to derive an ESI from National Hospital Ambulatory Medical Care Survey (NHAMCS) survey items (NHAMCS-ESI) and to assess the performance of this index with respect to stratifying outcomes, including hospital admission, waiting times, and ED length of stay (LOS). METHODS: We used data from the 2010-2015 NHAMCS, to create a measure of ED visit complexity based on variables within NHAMCS. We used NHAMCS data on chief complaint, vitals, resources used, interventions, and pain level to group ED visits into five levels of acuity using a stepwise algorithm that mirrored ESI. In addition, we examined associations of NHAMCS-ESI with typical indicators of acuity such as waiting time, LOS, and disposition. The NHAMCS-ESI categorization was also compared against the "immediacy" variable across all of these outcomes. Visit counts used weighted scores to estimate national levels of ED visits. RESULTS: The NHAMCS ED visits represent an estimated 805,726,000 ED visits over this time period. NHAMCS-ESI categorized visits somewhat evenly, with most visits (42.5%) categorized as a level 3. The categorization pattern is distinct from that of the "immediacy" variable within NHAMCS. Of admitted patients, 89% were categorized as NHAMCS-ESI level 2-3. Median ED waiting times increased as NHAMCS-ESI levels decreased in acuity (from approximately 14 minutes to 25 minutes). Median LOS decreased as NHAMCS-ESI decreased from almost 200 minutes for level 1 patients to nearly 80 minutes for level 5 patients. CONCLUSION: We derived an objective tool to measure an ED visit's complexity and resource use. This tool can be validated and used to compare complexity of ED visits across hospitals and regions, and over time.

Conscious Sedation Versus General Anesthesia for Transcatheter Aortic Valve Replacement: Variation in Practice and Outcomes.

OBJECTIVES: The aims of this study were to examine variation in the use of conscious sedation (CS) for transcatheter aortic valve replacement (TAVR) across hospitals and over time and to evaluate outcomes of CS compared with general anesthesia (GA) using instrumental variable analysis, a quasi-experimental method to control for unmeasured confounding. BACKGROUND: Despite increasing use of CS for TAVR, contemporary data on utilization patterns are lacking, and existing studies evaluating the impact of sedation choice on outcomes may suffer from unmeasured confounding. METHODS: Among 120,080 patients in the TVT (Transcatheter Valve Therapy) Registry who underwent transfemoral TAVR between January 2016 and March 2019, the relationship between anesthesia choice and TAVR outcomes was evaluated using hospital proportional use of CS as an instrumental variable. RESULTS: Over the study period, the proportion of TAVR performed using CS increased from 33% to 64%, and CS was used in a median of 0% and 91% of cases in the lowest and highest quartiles of hospital CS use, respectively. On the basis of instrumental variable analysis, CS was associated with decreases in in-hospital mortality (adjusted risk difference: 0.2%; p = 0.010) and 30-day mortality (adjusted risk difference: 0.5%; p < 0.001), shorter length of hospital stay (adjusted difference: 0.8 days; p < 0.001), and more frequent discharge to home (adjusted risk difference: 2.8%; p < 0.001) compared with GA. The magnitude of benefit for most endpoints was less than in a traditional propensity score-based approach, however. CONCLUSIONS: In contemporary U.S. practice, the use of CS for TAVR continues to increase, although there remains wide variation across hospitals. The use of CS for TAVR is associated with improved outcomes (including reduced mortality) compared with GA, although the magnitude of benefit appears to be less than in previous studies.