Cardiac Health Assessment Using a Wearable Device Before and After Transcatheter Aortic Valve Implantation: Prospective Study.

Background: Due to aging of the population, the prevalence of aortic valve stenosis will increase drastically in upcoming years. Consequently, transcatheter aortic valve implantation (TAVI) procedures will also expand worldwide. Optimal selection of patients who benefit with improved symptoms and prognoses is key, since TAVI is not without its risks. Currently, we are not able to adequately predict functional outcomes after TAVI. Quality of life measurement tools and traditional functional assessment tests do not always agree and can depend on factors unrelated to heart disease. Activity tracking using wearable devices might provide a more comprehensive assessment. Objective: This study aimed to identify objective parameters (eg, change in heart rate) associated with improvement after TAVI for severe aortic stenosis from a wearable device. Methods: In total, 100 patients undergoing routine TAVI wore a Philips Health Watch device for 1 week before and after the procedure. Watch data were analyzed offline-before TAVI for 97 patients and after TAVI for 75 patients. Results: Parameters such as the total number of steps and activity time did not change, in contrast to improvements in the 6-minute walking test (6MWT) and physical limitation domain of the transformed WHOQOL-BREF questionnaire. Conclusions: These findings, in an older TAVI population, show that watch-based parameters, such as the number of steps, do not change after TAVI, unlike traditional 6MWT and QoL assessments. Basic wearable device parameters might be less appropriate for measuring treatment effects from TAVI.

Trends and predictors of inflation-adjusted costs in transcatheter and surgical aortic valve replacement in a nationally representative sample.

BACKGROUND: Transcatheter aortic valve replacement has become an accepted alternative to surgical aortic valve replacement. We examined the trends and predictors in inflation-adjusted costs of transcatheter aortic valve replacement and surgical aortic valve replacement. METHODS: National Inpatient Sample identified patients who underwent aortic valve replacement for severe aortic stenosis by International Classification of Diseases, Ninth and Tenth Revisions, codes. Hospitalization costs were inflation-adjusted using the Federal Reserve's consumer price index to reflect current valuation. Outcomes of interest were unadjusted trend in annual cost for each procedure and predictors of in-patient cost. Generalized linear models with a log link function identified predictors of adjusted costs. Interaction terms determined where cost predictors were different by operation type. RESULTS: Between 2011 and 2019, the mean annual inflation-adjusted cost of surgical aortic valve replacement increased from $62,853 to $63,743, in contrast to decreasing cost of transcatheter aortic valve replacement from $64,913 to $56,042 ($1,854 per year; P = .004). Significant independent predictors of patient-level cost included operation type (transcatheter aortic valve replacement associated with $9,625 increase; P < .001), incidence of in-hospital mortality ($28,836 increase; P < .001), elective status ($2,410 decrease; P < .001), Elixhauser Index ($995 increase; P < .001), and postoperative length of stay ($2,014 per day increase; P < .001). Compared to discharges with Medicare, discharges with private insurance and Medicaid paid $736 less (P = .004) and $1,863 less (P = .01), respectively. Increasing hospital volume was a significant predictor of decreasing patient level cost (P < .001). CONCLUSION: Annual cost of transcatheter aortic valve replacement has decreased significantly and has been a more cost-effective modality compared to surgical aortic valve replacement since 2017. Predictors of patient-level costs allow for mindful preparation of healthcare systems for aortic valve replacement.

Introduction of transcatheter aortic valve replacement technology increases overall aortic valve surgical volume: Evaluating the Florida experience.

OBJECTIVE: Transcatheter aortic valve replacement technology is increasingly used for aortic valve stenosis. We sought to evaluate the adoption of transcatheter aortic valve replacement technology with respect to overall surgical aortic valve replacement volume in Florida. METHODS: The 2010-2019 Florida Agency for Health Care Administration data set was queried. Difference-in-difference analysis was used to evaluate the impact of transcatheter aortic valve replacement on the total aortic valve surgical volume of transcatheter aortic valve replacement versus nonperforming hospitals. Length of stay and elements of charges were compared for the raw and 1:1 propensity matched data. RESULTS: A total of 46,032 surgical aortic valve procedures were performed at 88 hospitals. Transcatheter aortic valve replacement performing hospitals experienced a 21% increase in total aortic valve surgical volume. Length of stay was significantly less for patients undergoing transcatheter aortic valve replacement. Propensity matched transcatheter aortic valve replacement patients had less gross total charges. CONCLUSION: Introduction of transcatheter aortic valve replacement technology significantly increased overall surgical aortic valve volume and may be associated with less gross total hospital charges.

The Impact of the COVID-19 Pandemic on Cardiac Procedure Wait List Mortality in Ontario, Canada.

BACKGROUND: The novel SARS-CoV-2 (COVID-19) pandemic has dramatically altered the delivery of healthcare services, resulting in significant referral pattern changes, delayed presentations, and procedural delays. Our objective was to determine the effect of the COVID-19 pandemic on all-cause mortality in patients awaiting commonly performed cardiac procedures. METHODS: Clinical and administrative data sets were linked to identify all adults referred for: (1) percutaneous coronary intervention; (2) coronary artery bypass grafting; (3) valve surgery; and (4) transcatheter aortic valve implantation, from January 2014 to September 2020 in Ontario, Canada. Piece-wise regression models were used to determine the effect of the COVID-19 pandemic on referrals and procedural volume. Multivariable Cox proportional hazards models were used to determine the effect of the pandemic on waitlist mortality for the 4 procedures. RESULTS: We included 584,341 patients who were first-time referrals for 1 of the 4 procedures, of whom 37,718 (6.4%) were referred during the pandemic. The pandemic period was associated with a significant decline in the number of referrals and procedures completed compared with the prepandemic period. Referral during the pandemic period was a significant predictor for increased all-cause mortality for the percutaneous coronary intervention (hazard ratio, 1.83; 95% confidence interval, 1.47-2.27) and coronary artery bypass grafting (hazard ratio, 1.96; 95% confidence interval, 1.28-3.01), but not for surgical valve or transcatheter aortic valve implantation referrals. Procedural wait times were shorter during the pandemic period compared with the prepandemic period. CONCLUSIONS: There was a significant decrease in referrals and procedures completed for cardiac procedures during the pandemic period. Referral during the pandemic was associated with increased all-cause mortality while awaiting coronary revascularization.

Inequities in Aortic Stenosis and Aortic Valve Replacement Between Black/African-American, White, and Hispanic Residents of Maryland.

Background Racial and ethnic inequities exist in surgical aortic valve replacement for aortic stenosis (AS), and early studies have suggested similar inequities in transcatheter aortic valve replacement. Methods and Results We performed a retrospective analysis of the Maryland Health Services Cost Review Commission inpatient data set from 2016 to 2018. Black patients had half the incidence of any inpatient AS diagnosis compared with White patients (incidence rate ratio [IRR], 0.50; 95% CI, 0.48-0.52; P<0.001) and Hispanic patients had one fourth the incidence compared with White patients (IRR, 0.25; 95% CI, 0.22-0.29; P<0.001). Conversely, the incidence of any inpatient mitral regurgitation diagnosis did not differ between White and Black patients (IRR, 1.00; 95% CI, 0.97-1.03; P=0.97) but was significantly lower in Hispanic compared with White patients (IRR, 0.36; 95% CI, 0.33-0.40; P<0.001). After multivariable adjustment, Black race was associated with a lower incidence of surgical aortic valve replacement (IRR, 0.67; 95% CI, 0.55-0.82 P<0.001 relative to White race) and transcatheter aortic valve replacement (IRR, 0.77; 95% CI, 0.65-0.90; P=0.002) among those with any inpatient diagnosis of AS. Hispanic patients had a similar rate of surgical aortic valve replacement and transcatheter aortic valve replacement compared with White patients. Conclusions Hospitalization with any diagnosis of AS is less common in Black and Hispanic patients than in White patients. In hospitalized patients with AS, Black race is associated with a lower incidence of both surgical aortic valve replacement and transcatheter aortic valve replacement compared with White patients, whereas Hispanic patients have a similar incidence of both. The reasons for these inequities are likely multifactorial.

Cardiovascular procedural deferral and outcomes over COVID-19 pandemic phases: A multi-center study.

BACKGROUND: The COVID-19 pandemic has disrupted routine cardiovascular care, with unclear impact on procedural deferrals and associated outcomes across diverse patient populations. METHODS: Cardiovascular procedures performed at 30 hospitals across 6 Western states in 2 large, non-profit healthcare systems (Providence St. Joseph Health and Stanford Healthcare) from December 2018-June 2020 were analyzed for changes over time. Risk-adjusted in-hospital mortality was compared across pandemic phases with multivariate logistic regression. RESULTS: Among 36,125 procedures (69% percutaneous coronary intervention, 13% coronary artery bypass graft surgery, 10% transcatheter aortic valve replacement, and 8% surgical aortic valve replacement), weekly volumes changed in 2 distinct phases after the initial inflection point on February 23, 2020: an initial period of significant deferral (COVID I: March 15-April 11) followed by recovery (COVID II: April 12 onwards). Compared to pre-COVID, COVID I patients were less likely to be female (P = .0003), older (P < .0001), Asian or Black (P = .02), or Medicare insured (P < .0001), and COVID I procedures were higher acuity (P < .0001), but not higher complexity. In COVID II, there was a trend toward more procedural deferral in regions with a higher COVID-19 burden (P = .05). Compared to pre-COVID, there were no differences in risk-adjusted in-hospital mortality during both COVID phases. CONCLUSIONS: Significant decreases in cardiovascular procedural volumes occurred early in the COVID-19 pandemic, with disproportionate impacts by race, gender, and age. These findings should inform our approach to future healthcare disruptions.

Expansion of transcatheter aortic valve replacement in the United States.

BACKGROUND: Patterns of diffusion of TAVR in the United States (U.S.) and its relation to racial disparities in TAVR utilization remain unknown. METHODS: We identified TAVR hospitals in the continental U.S. from 2012-2017 using Medicare database and mapped them to Hospital Referral Regions (HRR). We calculated driving distance from each residential ZIP code to the nearest TAVR hospital and calculated the proportion of the U.S. population, in general and by race, that lived <100 miles driving distance from the nearest TAVR center. Using a discrete time hazard logistic regression model, we examined the association of hospital and HRR variables with the opening of a TAVR program. RESULTS: The number of TAVR hospitals increased from 230 in 2012 to 540 in 2017. The proportion of the U.S. population living <100 miles from nearest TAVR hospital increased from 89.3% in 2012 to 94.5% in 2017. Geographic access improved for all racial and ethnic subgroups: Whites (84.1%-93.6%), Blacks (90.0%- 97.4%), and Hispanics (84.9%-93.7%). Within a HRR, the odds of opening a new TAVR program were higher among teaching hospitals (OR 1.48, 95% CI 1.16-1.88) and hospital bed size (OR 1.44, 95% CI 1.37-1.52). Market-level factors associated with new TAVR programs were proportion of Black (per 1%, OR 0.78, 95% CI 0.69-0.89) and Hispanic (per 1%, OR 0.82, 95% CI 0.75-0.90) residents, the proportion of hospitals within the HRR that already had a TAVR program (per 10%, OR 1.07, 95% CI 1.03-1.11), P <.01 for all. CONCLUSION: The expansion of TAVR programs in the U.S. has been accompanied by an increase in geographic coverage for all racial subgroups. Further study is needed to determine reasons for TAVR underutilization in Blacks and Hispanics.

Impact of Economic Status on Utilization and Outcomes of Transcatheter Aortic Valve Implantation and Mitraclip.

Data on the impact of economic status on Transcatheter aortic valve implantation (TAVI) and MitraClip (MC) is lacking. Patients who underwent TAVI and/or MC during 2012 to 2017 were identified in the Nationwide Readmission Database and divided by zip code estimated income quartile into 4 groups (Q1 to Q4). The utilization of TAVI and/or MC was defined as the number of TAVIs and/or MCs over all admissions with an aortic and/or mitral valve disease (AVD and/or MVD) and represented per 1,000 admissions. A total of 168,853 patients underwent TAVI; 20.6% in Q1, 26.3% in Q2, 27.3% in Q3, and 25.8% in Q4, while 15,387 patients underwent MC; 22% in Q1, 26.2% in Q2, 26.3% in Q3, and 25.5% in Q4. The annual utilization of TAVIs and/or MCs increased over the study period and was generally lower with lower income. In 2012, TAVI was performed for 8.2, 8.8, 10.8, and 11.3 per 1,000 AVD admissions in Q1, Q2, Q3, and Q4, respectively. In 2017, TAVI was performed for 54.1, 65.1, 68.6, and 71 per 1,000 AVD admissions in Q1, Q2, Q3, and Q4, respectively. In 2014, MC was performed for 1.6, 2.1, 1.8, and 1.9 per 1,000 MVD admissions in Q1, Q2, Q3, and Q4, respectively. In 2017, MC was performed for 5.6, 6.5, 8, and 8 per 1,000 MVD admissions in Q1, Q2, Q3, and Q4, respectively. In-hospital mortality, stroke, and 30-day readmissions were generally comparable across groups. Lower-income patients may be underrepresented among patients undergoing TAVI and MC despite comparable outcomes. Further studies are needed to examine the etiologies behind these disparities and identify targeted strategies for its mitigation.

Analysis of the Changing Economics of US Hospital Transcatheter Aortic Valve Replacement Programs.

New technologies in medicine, even if they are promising medically, are often expensive and logistically difficult to implement at the hospital level. Transcatheter aortic valve replacement (TAVR) is a model technology that is revolutionary in treating aortic stenosis, but has been plagued with significant challenges with financial sustainability. In this article, a margin analysis at the hospital level was performed using literature data. A TAVR industry analysis was performed using Porter's Five Forces framework. The data indicate that TAVR is more expensive than surgical aortic valve replacement, although the cost of TAVR is declining with the use of an optimized minimalist protocol. The overall industry is growing as its clinical indications expand, and it will likely undergo significant reduction of costs when new valves enter the US market. As such, TAVR is a growing industry, with financial sustainability currently dependent on operational efficiency. A concluding list of specific program interventions is provided to help TAVR programs improve operational efficiency and clinical outcomes, as well as help decide whether to create, expand, or redirect funding for TAVR programs. Importantly, the frameworks used to analyze this rapidly evolving technology can be applied to other new technologies to determine financial sustainability.

Epidemiological Features of Aortic Stenosis in a French Nationwide Study: 10-Year Trends and New Challenges.

Background Aortic stenosis (AS) is one of the most common forms of valvular heart disease. Our aim was to estimate the burden of AS in the hospital in France, describe patient characteristics, and evaluate the mortality rate and temporal trends. Methods and Results All patients hospitalized for AS in France between 2006 and 2016 were identified from the national hospital discharge database. Patients' sociodemographic, medical, and surgical characteristics and temporal trends were described. All AS-related deaths between 2000 and 2014 were identified using death certificates. In 2016, 26 071 patients were hospitalized for AS: 56.5% were men with an average age of 77 years. The all-cause mortality rate at 1 year postindex stay was 11%. The rate of patients hospitalized for AS increased by 59% between 2006 and 2016, reaching 38.7/100 000 person-years in 2016. This increase was most pronounced in patients aged >75 years. The number of transcatheter aortic valve implantations increased following their introduction in 2010. In 2016, 44% of patients were treated with aortic valve surgery during the index hospital stay or following year (mean age, 71.5 years), and 34% were treated with transcatheter aortic valve implantation (mean age, 83.0 years). In 2014, 6186 deaths caused by AS were identified in death certificates: 41.6% were men with an average age of 87 years. The age-standardized mortality rate increased by 5% between 2000 and 2014, reaching 8.5/100 000 person-years in 2014. Conclusions The rate of patients hospitalized for AS increased in recent years in line with the higher life expectancy and introduction of transcatheter aortic valve implantation. Mortality increased more moderately.

The Effects of Market Competition on Cardiologists' Adoption of Transcatheter Aortic Valve Replacement.

BACKGROUND: For decades, the prevailing assumption regarding the diffusion of high-cost medical technologies has been that competitive markets favor more aggressive adoption of new treatments by health care providers (ie, the "Medical Arms Race"). However, novel regulations governing the adoption of transcatheter aortic valve replacement (TAVR) may have disrupted this paradigm when TAVR was introduced. OBJECTIVE: The objective of this study was to assess the relationship between the market concentration of physician group practices and the adoption of TAVR in its first years of use. RESEARCH DESIGN: This was a retrospective cohort study. SUBJECTS: Physician group practices (n=5116) providing interventional cardiology services in the United States from May 1, 2012, to December 31, 2014. MEASURES: The first use of TAVR as indicated by a fee-for-service Medicare claim. Covariates including characteristics of the physician groups (ie, case volume, hospital affiliation, mean patient risk) as well as county-level and market-level characteristics. RESULTS: By the close of 2014, 9.3% of practices had adopted TAVR. Cox proportional hazards models revealed a hazard ratio of 1.26 (95% confidence interval: 1.16-1.37, P<0.001) per 1000 point increase in the physician group practice Herfindahl-Hirschman Index, indicating each 1000 point increase in group practice Herfindahl-Hirschman Index was associated with a 26% relative increase in the rate of TAVR adoption. CONCLUSIONS: Adoption of TAVR by physician groups in concentrated markets was potentially a consequence of the unique regulations governing TAVR reimbursement, which favored the adoption of TAVR by physician groups with greater market power. These findings have important implications for how future regulations may shape patterns of technology adoption.

Use of Administrative Claims to Assess Outcomes and Treatment Effect in Randomized Clinical Trials for Transcatheter Aortic Valve Replacement: Findings From the EXTEND Study.

BACKGROUND: Whether passively collected data can substitute for adjudicated outcomes to reproduce the magnitude and direction of treatment effect observed in cardiovascular clinical trials is not well known. METHODS: We linked adults ≥65 years of age in the HiR (US CoreValve Pivotal High Risk) and SURTAVI trials (Surgical or Transcatheter Aortic Valve Replacement in Intermediate-Risk Patients) to 100% Medicare inpatient claims, January 1, 2011, to December 31, 2016. Primary (eg, death and stroke) and secondary trial end points were compared across treatment arms (eg, transcatheter aortic valve replacement [TAVR] versus surgical aortic valve replacement [SAVR]) using trial-adjudicated outcomes versus outcomes derived from claims at 1 year (HiR) or 2 years (SURTAVI). RESULTS: Among 600 linked HiR participants (linkage rate, 80.0%), the rate of the trial's primary end point of all-cause mortality occurred in 13.7% of patients receiving TAVR and 16.4% of patients receiving SAVR at 1 year by using both trial data (hazard ratio, 0.84 [95% CI, 0.65-1.09]; P=0.33) and claims data (hazard ratio, 0.86 [95% CI, 0.66-1.11]; P=0.34; interaction P value=0.80). Noninferiority of TAVR relative to SAVR was seen by using both trial- and claims-based outcomes (Pnoninferiority<0.001 for both). Among 1005 linked SURTAVI trial participants (linkage rate, 60.5%), the trial's primary end point was 12.9% for TAVR and 13.1% for SAVR using trial data (hazard ratio, 1.08 [95% CI, 0.79-1.48]; P=0.90), and 11.3% for TAVR and 12.5% for SAVR patients using claims data (hazard ratio, 1.02 [95% CI, 0.73-1.41]; P=0.58; interaction P value=0.89). TAVR was noninferior to SAVR when compared using both trial and claims (Pnoninferiority<0.001 for both). Rates of procedural secondary outcomes (eg, aortic valve reintervention, pacemaker rates) were more closely concordant between trial and claims data than nonprocedural outcomes (eg, stroke, bleeding, cardiogenic shock). CONCLUSIONS: In the HiR and SURTAVI trials, ascertainment of trial primary end points using claims reproduced both the magnitude and direction of treatment effect in comparison with adjudicated event data, but nonfatal and nonprocedural secondary outcomes were not as well reproduced. Use of claims to substitute for adjudicated outcomes in traditional trial treatment comparisons may be valid and feasible for all-cause mortality and certain procedural outcomes but may be less suitable for other end points.

Inequity in Access to Transcatheter Aortic Valve Replacement: A Pan-Canadian Evaluation of Wait-Times.

BACKGROUND: There has been an exponential increase in the demand for transcatheter aortic valve replacement (TAVR). Our goal was to examine trends in TAVR capacity and wait-times across Canada. METHODS: All TAVR cases were identified from April 1, 2014, to March 31, 2017. Wait-time was defined as the duration in days from the initial referral to the TAVR procedure. TAVR capacity was defined as the number of TAVR procedures per million population/province/fiscal year. We performed multivariable multilevel Cox proportional hazards modelling of the time to TAVR as the dependant variable and the effect of provinces as random effects. We quantified the variation in wait-times among provinces using the median hazard ratio. RESULTS: We identified a total of 4906 TAVR procedures across 9 provinces. Despite a year over year increase in overall capacity, there was a greater than 3-fold difference in capacity between provinces. Crude median wait-times increased over time in all provinces, with marked variation from 71.5 days in Newfoundland to 190.5 and 203 days in Manitoba and Alberta, respectively. This suggests increasing demand outpaced the growth in capacity. We found a median hazard ratio of 1.62, indicating that in half of the possible pairwise comparisons, the time to TAVR for identical patients was at least 62% longer between different provinces. CONCLUSION: We found substantial geographic inequity in TAVR access. This calls for policy makers, clinicians, and administrators across Canada to address this inequity through revaluation of provincial funding mechanisms, as well as implementation of efficient care pathways.

Transcatheter Aortic Valve Implantation in Patients With Severe, Symptomatic Aortic Valve Stenosis at Intermediate Surgical Risk: A Health Technology Assessment.

BACKGROUND: Surgical aortic valve replacement (SAVR) is the conventional treatment in patients at low or intermediate surgical risk. Transcatheter aortic valve implantation (TAVI) is a less invasive procedure, originally developed as an alternative for patients at high or prohibitive surgical risk. METHODS: We conducted a health technology assessment of TAVI versus SAVR in patients with severe, symptomatic aortic valve stenosis at intermediate surgical risk, which included an evaluation of effectiveness, safety, cost-effectiveness, budget impact, and patient preferences and values. We performed a literature search to retrieve systematic reviews and selected one that was relevant to our research question. We complemented the systematic review with a literature search to identify randomized controlled trials published after the review. Applicable, previously published cost-effectiveness analyses were available, so we did not conduct a primary economic evaluation. We analyzed the net budget impact of publicly funding TAVI in people at intermediate surgical risk in Ontario. To contextualize the potential value of TAVI for people at intermediate surgical risk, we spoke with people who had aortic valve stenosis and their families. RESULTS: We identified two randomized controlled trials; they found that in patients with severe, symptomatic aortic valve stenosis, TAVI was noninferior to SAVR with respect to the composite endpoint of all-cause mortality or disabling stroke within 2 years of follow-up (GRADE: High). However, compared with SAVR, TAVI had a higher risk of some complications and a lower risk of others. Device-related costs for TAVI (approximately $23,000) are much higher than for SAVR (approximately $6,000). Based on two published cost-effectiveness analyses conducted from the perspective of the Ontario Ministry of Health, TAVI was more expensive and, on average, more effective (i.e., it produced more quality-adjusted life-years) than SAVR. The incremental cost-effectiveness ratios showed that TAVI may be cost-effective, but the probability of TAVI being cost-effective versus SAVR was less than 60% at a willingness-to-pay value of $100,000 per quality-adjusted life-year. The net budget impact of publicly funding TAVI in Ontario would be about $2 million to $3 million each year for the next 5 years. This cost may be reduced if people receiving TAVI have a shorter hospital stay (≤ 3 days). We interviewed 13 people who had lived experience with aortic valve stenosis. People who had undergone TAVI reported reduced physical and psychological effects and a shorter recovery time. Patients and caregivers living in remote or northern regions reported lower out-of-pocket costs with TAVI because the length of hospital stay was reduced. People said that TAVI increased their quality of life in the short-term immediately after the procedure. CONCLUSIONS: In people with severe, symptomatic aortic valve stenosis at intermediate surgical risk, TAVI was similar to SAVR with respect to the composite endpoint of all-cause mortality or disabling stroke. However, the two treatments had different patterns of complications. The study authors also noted that longer follow-up is needed to assess the durability of the TAVI valve. Compared with SAVR, TAVI may provide good value for money, but publicly funding TAVI in Ontario would result in additional costs over the next 5 years. People with aortic valve stenosis who had undergone TAVI appreciated its less invasive nature and reported a substantial reduction in physical and psychological effects after the procedure, improving their quality of life.

Changes in the socioeconomic status of patients receiving TAVR in New York State.

BACKGROUND: When transcatheter aortic valve replacement (TAVR) was first approved by the Food and Drug Administration in October 2011, it was an innovative treatment with limited accessibility. However, over the past few years, TAVR has become standard of care in patients with aortic stenosis. The effect of socioeconomic status (SES) on this transition of use of TAVR is unknown. METHOD: Using the New York state department Statewide Planning and Research Cooperative System database, we compared baseline patient characteristics and facilities in low-income areas and high-income areas. Trends in residential SES of patients undergoing TAVR were examined over time and assessed with a Poisson regression and Cochran Armitage trend tests. RESULT: From October 2011 and 2012 to December 2016, we found that the numbers of TAVR procedures performed among patients from both low (187-1150 in 2016, P < .001) and high (227-1160, P < .001) income areas increased over time. The proportion of TAVR procedures performed in patients from low-income areas increased over time, while those in high-income areas decreased (from 45.2% in 2011 and 2012 to 49.8% in 2016 for low-income and from 54.8%-50.2% for high-income, P = .009). CONCLUSION: In the case of TAVR in New York State, when the innovative treatment was introduced in the clinical practice, there were initial SES-based disparities in access to the procedure. However, these disparities resolved over time, probably due to the broader diffusion of the technique.

Cost-Effectiveness of Transcatheter Aortic Valve Implantation Using a Balloon-Expandable Valve in Japan: Experience From the Japanese Pilot Health Technology Assessment.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) is an innovative and effective treatment in high-surgical-risk (HR) and inoperable patients with symptomatic severe aortic stenosis. OBJECTIVES: This cost-effectiveness analysis of transfemoral TAVI (TF-TAVI) compared with surgical aortic valve replacement (SAVR) conforms with the methodological guidelines for cost-effectiveness evaluation by the Ministry of Health, Labor, and Welfare in Japan. METHODS: The cost-effectiveness of TF-TAVI using SAPIEN XT was evaluated using a lifetime Markov simulation from the national payer perspective. Comparators were SAVR for HR patients and standard of care (SOC) for inoperable patients. A systematic literature review for clinical evidence of TF-TAVI and comparators was conducted. The evidence for TF-TAVI was derived from the SOURCE XT registry and Japanese post marketing surveillance. Because there was no literature directly or indirectly comparing TF-TAVI using SAPIEN XT with comparators, the comparator data were selected from relevant published studies, considering the similarity of study eligibility criteria and patient backgrounds (eg, age and surgical risk scores). Sensitivity analyses were used to validate the robustness of results. RESULTS: The incremental cost-effectiveness ratio of TF-TAVI versus SAVR for HR patients was ¥1.3 million/quality-adjusted life-years (QALYs). The incremental cost-effectiveness ratio of TF-TAVI versus SOC for inoperable patients was ¥3.5 million/QALY. CONCLUSIONS: TF-TAVI was cost-effective when compared with SAVR for HR patients and when compared with SOC for inoperable patients, using a threshold of ¥5 million/QALY.

The Effect of Hospital Market Competition on the Adoption of Transcatheter Aortic Valve Replacement.

BACKGROUND: The use of transcatheter aortic valve replacement (TAVR) has grown rapidly. The purpose of this study was to assess whether hospital market competition was associated with the use of TAVR. METHODS: We used 5 Healthcare Cost and Utilization Project state inpatient databases (Arizona, Florida, Iowa, Massachusetts, Washington) to identify patients undergoing TAVR (n = 5563) or surgical aortic valve replacement (n = 30,672) across 154 hospitals from 2011 to 2014. Using the Herfindahl-Hirschman Index (HHI) to calculate market competition, hospitals were categorized into commonly used categories of low (HHI >0.25), moderate (HHI 0.15-0.25), and high (HHI <0.15) competition. We associated market competition category with TAVR utilization using hierarchical logistic regression, adjusting for patient characteristics, hospital characteristics, year, and hospital random effect. We modeled associations between HHI category and in-hospital mortality, admission length of stay, and discharge to home as secondary outcomes. RESULTS: After adjustment, patients treated at high-competition hospitals had higher odds of receiving TAVR, relative to patients at low-competition hospitals (adjusted odds ratio [ORadj], 5.31; 95% confidence interval [CI], 2.10-13.4). TAVR use increased each year (ORadj, 1.73; 95% CI, 1.38-2.17) but was similar across HHI categories. Competition was not associated with in-hospital mortality or length of stay. Patients at high-competition hospitals were more likely to be discharged home (ORadj, 2.39; 95% CI, 1.23-4.66) compared with patients at low-competition hospitals. CONCLUSIONS: Market competition was positively associated with a hospital's adoption of TAVR. Future studies should further examine the impact of competition on quality and appropriateness.

Clinical and economic outcomes of ProGlide compared with surgical repair of large bore arterial access.

Aim: This study compared real-world complication rates, hospitalization duration and costs, among patients undergoing arterial repair using the Perclose ProGlide (ProGlide) versus surgical cutdown (Cutdown). Materials & methods: Retrospective study of matched patients who underwent transcatheter aortic valve replacement/repair, endovascular abdominal aortic aneurysm repair, thoracic endovascular aortic repair or balloon aortic valvuloplasty with arterial repair by either ProGlide or Cutdown between 1 January 2013 and 24 April 2017. Results: Infections and blood transfusions were lower in the ProGlide cohort. Patients in the ProGlide cohort had a 42.5% shorter index hospitalization, which corresponded to US$14,687 lower costs. Conclusion: The use of ProGlide for arterial repair was associated with significantly lower transfusion rates, shorter index hospitalization and lower hospitalization costs compared with surgical cutdown.

Procedural Volume and Outcomes for Transcatheter Aortic-Valve Replacement.

BACKGROUND: During the introduction of transcatheter aortic-valve replacement (TAVR) in the United States, requirements regarding procedural volume were mandated by the Centers for Medicare and Medicaid Services as a condition of reimbursement. A better understanding of the relationship between hospital volume of TAVR procedures and patient outcomes could inform policy decisions. METHODS: We analyzed data from the Transcatheter Valve Therapy Registry regarding procedural volumes and outcomes from 2015 through 2017. The primary analyses examined the association between hospital procedural volume as a continuous variable and risk-adjusted mortality at 30 days after transfemoral TAVR. Secondary analysis included risk-adjusted mortality according to quartile of hospital procedural volume. A sensitivity analysis was performed after exclusion of the first 12 months of transfemoral TAVR procedures at each hospital. RESULTS: Of 113,662 TAVR procedures performed at 555 hospitals by 2960 operators, 96,256 (84.7%) involved a transfemoral approach. There was a significant inverse association between annualized volume of transfemoral TAVR procedures and mortality. Adjusted 30-day mortality was higher and more variable at hospitals in the lowest-volume quartile (3.19%; 95% confidence interval [CI], 2.78 to 3.67) than at hospitals in the highest-volume quartile (2.66%; 95% CI, 2.48 to 2.85) (odds ratio, 1.21; P = 0.02). The difference in adjusted mortality between a mean annualized volume of 27 procedures in the lowest-volume quartile and 143 procedures in the highest-volume quartile was a relative reduction of 19.45% (95% CI, 8.63 to 30.26). After the exclusion of the first 12 months of TAVR procedures at each hospital, 30-day mortality remained higher in the lowest-volume quartile than in the highest-volume quartile (3.10% vs. 2.61%; odds ratio, 1.19; 95% CI, 1.01 to 1.40). CONCLUSIONS: An inverse volume-mortality association was observed for transfemoral TAVR procedures from 2015 through 2017. Mortality at 30 days was higher and more variable at hospitals with a low procedural volume than at hospitals with a high procedural volume. (Funded by the American College of Cardiology Foundation National Cardiovascular Data Registry and the Society of Thoracic Surgeons.).

Hospital Resource Utilization Before and After Transcatheter Aortic Valve Replacement: The STS/ACC TVT Registry.

BACKGROUND: Patients with severe aortic stenosis (AS) have repeat hospitalizations for multiple conditions. OBJECTIVES: The purpose of this study was to assess the effect of transcatheter aortic valve replacement (TAVR) on hospitalizations in severe AS. METHODS: Using data from the Society of Thoracic Surgeons/American College of Cardiology TVT (Transcatheter Valve Therapy) registry with linkage to Medicare claims, the authors examined rates of all-cause, cardiovascular, and noncardiovascular hospitalizations and hospital days, as well as inpatient costs in the year pre-TAVR and post-TAVR. Multivariable modeling was used to determine rate ratios of post-TAVR versus pre-TAVR hospitalizations and costs. RESULTS: Among 15,324 patients at 328 sites with Medicare linkage undergoing TAVR, the median age was 84 years, the median Society of Thoracic Surgeons Predicted Risk of Mortality score was 7.0, and 61.1% patients underwent TAVR via transfemoral access. Post-TAVR, heart failure hospitalization rates and hospitalized days were reduced compared with pre-TAVR (rate ratio: 0.87 and 0.95 respectively; p < 0.01 for all). However, all-cause, noncardiovascular, and bleeding hospitalization rates and hospitalized days were increased (p < 0.01 for all). Post-TAVR hospitalizations were reduced the most among those with left ventricular ejection fraction <30%. Mean post-TAVR costs were reduced among all TAVR patients and among 1-year survivors (rate ratio: 0.95, p < 0.01; and 0.90; p < 0.01, respectively). CONCLUSIONS: Patients had lower costs and fewer heart failure hospitalizations but more all-cause, noncardiovascular, and bleeding hospitalizations post-TAVR. Reduction in hospitalizations varied by specific patient subgroups, and thus, payors and providers seeking to reduce resource use may consider strategies designed to improve processes of care among patients with increased resource utilization post-TAVR as compared with pre-TAVR.