Cost-effectiveness analysis of transcatheter aortic valve implantation in aortic stenosis patients at low- and intermediate-surgical risk in Japan.

OBJECTIVE: To analyze the cost-effectiveness of transcatheter aortic valve implantation (TAVI) using the SAPIEN 3 (Edwards Lifesciences, Irvine, CA) compared to surgical aortic valve replacement (SAVR) in low- and intermediate-risk patients from a Japanese public healthcare payer perspective. METHODS: A Markov model cost-effectiveness analysis was developed. Clinical and utility data were extracted from a systematic literature review. Cost inputs were obtained from analysis of the Medical Data Vision claims database and supplemented with a targeted literature search. The robustness of the results was assessed using sensitivity analyses. Scenario analyses were performed to determine the impact of lower mean age (77.5 years) and the effect of two different long-term mortality hazard ratios (TAVI versus SAVR: 0.9-1.09) on both risk-level populations. This analysis was conducted according to the guidelines for cost-effectiveness evaluation in Japan from Core 2 Health. RESULTS: In intermediate-risk patients, TAVI was a dominant procedure (TAVI had lower cost and higher effectiveness). In low-risk patients, the incremental cost effectiveness ratio (ICER) for TAVI was ¥750,417/quality-adjusted-life-years (QALY), which was below the cost-effectiveness threshold of ¥5 million/QALY. The ICER for TAVI was robust to all tested sensitivity and scenario analyses. CONCLUSIONS: TAVI was dominant and cost-effective compared to SAVR in intermediate- and low-risk patients, respectively. These results suggest that TAVI can provide meaningful value to Japanese patients relative to SAVR, at a reasonable incremental cost for patients at low surgical risk and potentially resulting in cost-savings in patients at intermediate surgical risk.

Aortic Stenosis (AS) is the most common valvular heart disease in Japan, and, if left untreated, severe symptomatic AS (sSAS) is associated with a dramatic increase in mortality and morbidity. Transcatheter Aortic Valve Implantation (TAVI) is a minimally invasive treatment option for replacing the aortic valve in patients with sSAS and has been associated with similar or better outcomes compared to Surgical Aortic Valve Replacement (SAVR), which involves open-heart surgical replacement of the aortic valve. The objective of this study was to compare the costs and health outcomes associated with TAVI compared to SAVR in Japanese patients deemed low- or intermediate-risk for surgery. Despite the expanding use of TAVI in Japan, a cost-effectiveness analysis (CEA) does not exist that evaluates the economics of TAVI with the current generation SAPIEN 3 implant in patients with low- and intermediate-risk from a public perspective. Our study suggests that TAVI represents strong value for money among low- and intermediate-risk patients in Japan: compared to SAVR, TAVI is associated with better clinical outcomes and quality of life for patients, at a reasonable additional cost for low-risk patients and at a lower cost for intermediate-risk patients.

Uncovering the treatable burden of severe aortic stenosis in the UK.

OBJECTIVE: To estimate the population prevalence and treatable burden of severe aortic stenosis (AS) in the UK. METHODS: We adapted a contemporary model of the population profile of symptomatic and asymptomatic severe AS in Europe and North America to estimate the number of people aged ≥55 years in the UK who might benefit from surgical aortic valve replacement (SAVR) or transcatheter aortic valve implantation (TAVI). RESULTS: With a point prevalence of 1.48%, we estimate that 291 448 men and women aged ≥55 years in the UK had severe AS in 2019. Of these, 68.3% (199 059, 95% CI 1 77 201 to 221 355 people) would have been symptomatic and, therefore, more readily treated according to their surgical risk profile; the remaining 31.7% of cases (92 389, 95% CI 70 093 to 144 247) being asymptomatic. Based on historical patterns of intervention, 58.4% (116 251, 95% CI 106 895 to 1 25 606) of the 199 059 symptomatic cases would qualify for SAVR, with 7208 (95% CI 7091 to 7234) being assessed as being in a high, preoperative surgical risk category. Among the remaining 41.6% (82 809, 95% CI 73 453 to 92 164) of cases potentially unsuitable for SAVR, an estimated 61.7% (51 093, 95% CI 34 780 to 67 655) might be suitable for TAVI. We estimate that 172 859 out of 291 448 prevalent cases of severe AS (59.3%) will subsequently die within 5 years without proactive management. CONCLUSIONS: These data suggest a high burden of severe AS in the UK requiring surgical or transcatheter intervention that challenges the ongoing capacity of the National Health Service to meet the needs of those affected.

Cumulative burden of clinically significant aortic stenosis in community-dwelling older adults.

OBJECTIVES: Current estimates of aortic stenosis (AS) frequency have mostly relied on cross-sectional echocardiographic or longitudinal administrative data, making understanding of AS burden incomplete. We performed case adjudications to evaluate the frequency of AS and assess differences by age, sex and race in an older cohort with long-term follow-up. METHODS: We developed case-capture methods using study echocardiograms, procedure and diagnosis codes, heart failure events and deaths for targeted review of medical records in the Cardiovascular Health Study to identify moderate or severe AS and related procedures or hospitalisations. The primary outcome was clinically significant AS (severe AS or procedure). Assessment of incident AS burden was based on subdistribution survival methods, while associations with age, sex and race relied on cause-specific survival methods. RESULTS: The cohort comprised 5795 participants (age 73±6, 42.2% male, 14.3% Black). Cumulative frequency of clinically significant AS at maximal 25-year follow-up was 3.69% (probable/definite) to 4.67% (possible/probable/definite), while the corresponding 20-year cumulative incidence was 2.88% to 3.71%. Of incident cases, about 85% had a hospitalisation for severe AS, but roughly half did not undergo valve intervention. The adjusted incidence of clinically significant AS was higher in men (HR 1.62 [95% CI 1.21 to 2.17]) and increased with age (HR 1.08 [95% CI 1.04 to 1.11]), but was lower in Blacks (HR 0.43 [95% CI 0.23 to 0.81]). CONCLUSIONS: In this community-based study, we identified a higher burden of clinically significant AS than reported previously, with differences by age, sex and race. These findings have important implications for public health resource planning, although the lower burden in Blacks merits further study.

A Real-World Comparison of 1-Year Survival and Expenditures for Transcatheter Aortic Valve Replacements: SAPIEN 3 Versus CoreValve Versus Evolut R.

OBJECTIVES: New versions of balloon-expandable and self-expandable valves for transcatheter aortic valve replacement (TAVR) have been developed, but few studies have examined the outcomes associated with these devices using national-level data. This study aimed to elucidate the clinical and economic outcomes of TAVR for aortic stenosis in Japan through an analysis of real-world data. METHODS: This retrospective cohort study was performed using data from patients with aortic stenosis who had undergone transfemoral TAVR with Edwards SAPIEN 3, Medtronic CoreValve, or Medtronic Evolut R valves throughout Japan from April 2016 to March 2018. Pacemaker implantation, mortality, and health expenditure were examined for each valve type during hospitalization and at 1 month, 3 months, 6 months, and 1 year. Generalized linear regression models and Cox proportional hazards models were used to examine the associations between the valve types and outcomes. RESULTS: We analyzed 7244 TAVR cases (SAPIEN 3: 5276, CoreValve: 418, and Evolut R: 1550) across 145 hospitals. The adjusted 1-year expenditures for SAPIEN 3, CoreValve, and Evolut R were $79 402, $76 125, and $75 527, respectively; SAPIEN 3 was significantly more expensive than the other valves (P < .05). The pacemaker implantation hazard ratios (95% confidence intervals) for CoreValve and Evolut R were significantly higher (P < .001) than SAPIEN 3 at 2.61 (2.07-3.27) and 1.80 (1.53-2.12), respectively. The mortality hazard ratios (95% confidence intervals) for CoreValve and Evolut R were not significant at 1.11 (0.84-1.46) and 1.22 (0.97-1.54), respectively. CONCLUSIONS: SAPIEN 3 users had generally lower pacemaker implantation and mortality but higher expenditures than CoreValve and Evolut R users.

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.

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.

Temporal Trends in Resource Use, Cost, and Outcomes of Transcatheter Aortic Valve Replacement in the United States.

OBJECTIVE: To evaluate the contemporary trends in outcomes and resource use associated with transcatheter aortic valve replacement (TAVR) in the United States. METHODS: We identified patients who underwent TAVR between January 1, 2012, and December 31, 2017, in the National Readmission Database. We assessed temporal trends in clinical outcomes, length-of-stay, non-home discharges, and cost of the index TAVR hospitalization. We also evaluated the changes in the burden of hospitalizations before and after TAVR. RESULTS: A total of 89,202 patients were included. In-hospital mortality decreased from 5.3% (188) in 2012 to 1.6% (484) in 2017 (adjusted odds ratio: 0.37, 95% CI: 0.30 to 0.46). Risk-adjusted incidences of new dialysis, vascular complications, blood transfusion, and mechanical ventilation decreased, but strokes and pacemaker implantations remained unchanged. Length of stay decreased from median of 7 (interquartile range [IQR]: 4 to 11) to 2 (IQR: 2 to 5) days (P<.001). Risk-adjusted non-home discharges decreased from 32.2% (1134) to 15.5% (386) (P<.001). Median cost of the TAVR hospitalization decreased from $56,022 (IQR: $43,690 to $75,174) to $46,101 (IQR: $36,083 to $59,752) (P<.001). Pre-TAVR admissions at 30, 90, and 180 days decreased from 21.6% (713), 39.5% (1160), and 50.5% (1009) in 2012 to 15.5% (4451), 30.2% (7186), and 36.8% (5928) in 2017, respectively (P<.001). Similarly, re-hospitalizations at 30, 90, and 180 days post-TAVR decreased from 17.5% (531), 27.9% (657), and 34.2% (521) to 12.4% (3486), 21.1% (4783), and 29.1% (4306), respectively (P<.001). The expenditure on index, pre-, and post-TAVR hospitalizations increased from $0.53 to $2.8 billion between 2012 and 2017. CONCLUSION: This study reflects the changes in the characteristics and outcomes of TAVR in the United States between 2012 and 2017. It also shows the temporal decrease in resource use, cost, and burden of hospitalizations among patients undergoing TAVR in the United States, but an increase in the overall expenditure on TAVR-related hospitalizations.

Transcatheter versus surgical aortic valve replacement in patients with end stage renal disease.

OBJECTIVE: To assess contemporary national trends of comorbidities, outcomes, and health care resource utilization in patients with aortic stenosis (AS) and end-stage renal disease (ESRD) undergoing transcatheter and surgical aortic valve replacement (TAVR and SAVR). METHODS AND RESULTS: The National-Inpatient-Sample was used to study trends in patients with AS and ESRD undergoing TAVR and SAVR between January 2012 and December 2017. Of 12,550 patients, 5,735 underwent TAVR and 6,815 underwent SAVR. Over the years, the utilization of SAVR declined (from 82.0 to 37.7%); and increased for TAVR (from 18.0 to 62.3%; p < .001). Patients receiving TAVR were older (74.6 [9.1] vs. 66.8 years [9.1]), had a higher proportion of females (37.1 vs. 32.5%), Caucasians (68.7 vs. 60.9%) and Asian /Pacific Islanders (3.1 vs. 2.7%; p < .001 for all). The TAVR patients, despite having higher comorbidity burden (anemia, coronary artery disease, chronic pulmonary disease, congestive heart failure, cerebrovascular disease, and peripheral vascular disease) had lower inpatient mortality and complications (ST-elevation myocardial infarction, pneumonia, pneumothorax, pulmonary embolism, cardiogenic shock, cardiac arrest, and need for mechanical ventilators and vasopressors). The median length of stay (13.9-6.5 days; p < .001) and cost of stay ($311,538.16 to $255,693.40; p < .001) reduced with TAVR; but remained unchanged with SAVR. Higher proportion of patients was discharged home after TAVR vs. SAVR. CONCLUSION: Among patients with AS and ESRD, despite providing therapy to subjects with higher comorbidity burden, TAVR was associated with lower inpatient mortality, complications, length of stay, cost of care, and higher home disposition rates when compared with SAVR.

Trends in Costs and Risk Factors of 30-Day Readmissions for Transcatheter Aortic Valve Implantation.

As transcatheter aortic valve implantation (TAVI) continues its rapid growth as a treatment approach for aortic stenosis, costs associated with TAVI, and its burden to healthcare systems will assume greater importance. Patients undergoing TAVI between January 2012 and November 2017 in the Nationwide Readmission Database were identified. Trends in cause-specific readmissions were assessed using Poisson regression. Thirty-day TAVI cost burden (cost of index TAVI hospitalization plus total 30-day readmissions cost) was adjusted to 2017 U.S. dollars and trended over year from 2012 to 2017. Overall, 47,255 TAVI were included and 30-day readmissions declined from 20% to 12% (p <0.0001). Most common causes of readmission (heart failure, infection/sepsis, gastrointestinal causes, and respiratory) declined as well, except arrhythmia/heart block which increased (1.0% to 1.4%, p <0.0001). Cost of TAVI hospitalization ($52,024 to $44,110, p <0.0001) and 30-day cost burden ($54,122 to $45,252, p <0.0001) declined. Whereas costs of an average readmission did not change ($9,734 to $10,068, p = 0.06), cost burden of readmissions (per every TAVI performed) declined ($4,061 to $1,883, p <0.0001), including reductions in each of the top 5 causes except arrhythmia/heart block ($171 to $263, p = 0.04). Index TAVI hospitalizations complicated by acute kidney injury, length of stay ≥5 days, low hospital procedural volume, and skilled nursing facility discharge were associated with increased odds of 30-day readmissions. In conclusion, the costs of index hospitalizations and 30-day cost burden for TAVI in the U.S. significantly declined from 2012 to 2017. However, readmissions due to arrhythmia/heart block and their associated costs increased. Continued strategies to prevent readmissions, especially those for conduction disturbances, are crucial in the efforts to optimize outcomes and costs with the ongoing expansion of TAVI.

Predictors of Cumulative Health Care Costs Associated With Transcatheter Aortic Valve Replacement in Severe Aortic Stenosis.

BACKGROUND: There is wide variation in hospitalization costs for transcatheter aortic valve replacement (TAVR), suggesting inefficiency in care delivery. Our goal was to identify drivers of health care costs in TAVR. METHODS: Demographics, procedural details, in-hospital complications, and costs for all adults undergoing first-time TAVR from 2012 to 2016 in Ontario, Canada, were obtained through linkages of clinical/administrative databases. Total costs included were from initial referral to the first of either death or 1-year post-TAVR. Phase-based costing was performed to empirically estimate the presence, duration, and cost per patient for each phase up to 1 year or death. Multivariable regression was used to identify drivers of cost accumulation per phase. RESULTS: We identified 2009 first-time TAVR patients (mean age 81.7 ± 7.6, 45.9% female and Society of Thoracic Surgeons (STS) score of 7.2 ± 5.8). Phases of cost were identified with an early high-cost period within 60 days of referral, a second phase from the procedure to 60 days, and a stable phase from 60 to 360 days postprocedure. The referral phase median cost was $4527 (interquartile range [IQR]: 1708-12,594), the procedure to 60 days phase median cost was $29,518 (IQR: 24,842-40,279), and the post 60-day stable phase median cost was $6053 (IQR: 3320-17,048). Predictors of higher cost in the referral phase were in-hospital wait location, dialysis dependence, and heart-failure status. In the second (procedural) phase, predictors were nontransfemoral access, complications of stroke, and pacemaker insertion. Predictors of higher cost in the third (stable) phase were predominantly nonmodifiable, such as frailty. CONCLUSIONS: This analysis shows that there are 3 distinct phases of cost accumulation from referral to post-TAVR with some potentially modifiable cost drivers in each phase.

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.

Impact of COPD on outcomes in hospitalized patients treated with transcatheter aortic valve implantation or surgical aortic valve replacement in Spain.

OBJECTIVES: To describe the use of transcatheter aortic valve implantation (TAVI) and conventional surgery (SAVR) among hospitalized patients with and without COPD, to compare the in-hospital mortality (IHM), length of hospital stay (LOHS) and cost between patients with COPD undergoing TAVI and SAVR and to identify factors associated to IHM among these patients. BACKGROUND: TAVI would be expected to be less invasive and safer than SAVR among COPD patients. METHODS: We analyzed patients whose medical procedures included TAVI and SAVR included in the Spanish National Hospital Discharge Database, 2014-2015. We stratified analysis by COPD status. Propensity score matching (1:2) was performed to assess the outcomes of TAVI vs. SAVR among COPD patients. RESULTS: We identified 2,141 and 16,013 patients who underwent TAVI (27.60% with COPD) and SAVR (19.31% with COPD) respectively. For TAVI, we found no differences in IHM according to COPD status. Patients undergoing SAVR and suffering COPD had higher IHM than patients without COPD (adj.OR 1.32; 95%CI 1.10-1.58). After propensity score matching, IHM (8.35% vs. 5.83%, p = .040) and LOHS (18.62 days vs. 13.62; p < .001) were higher in COPD patients who underwent SAVR than those who underwent TAVI. CONCLUSIONS: COPD patients undergoing TAVI did not have a worse prognosis compared to non-COPD patients during hospitalization. However, for SAVR, patients with COPD had significantly higher mortality than patients without this condition. COPD patients who underwent SAVR had higher IHM and LOHS than propensity score matched TAVI patients.

Relation of Frailty to Cost for Patients Undergoing Transcatheter Aortic Valve Implantation.

Frailty is associated with significant morbidity and mortality for patients undergoing transcatheter aortic valve implantation (TAVI). In addition to clinical outcomes, cost is an important factor to inform clinical decision-making around TAVI. However, the association of frailty with cost is unknown. This study tested whether frailty was associated with cost for adult patients who underwent TAVI at a moderate-volume single center between December 2012 and April 2018 (n = 431). Frailty was determined from pre-TAVI clinical visits as a composite of 2 markers: 5-meter walk time (abnormal: >6 seconds or unable to perform) and serum albumin (abnormal: <3.5 g/dl). Patients were excluded if missing frailty assessment or covariate data (24). Cost data were derived from financial statements, and assigned at the department-level by charge code. Multivariable regression models were adjusted for age, gender, and procedural co-morbidities. Of 407 patients in the analytical sample (mean age 81 years, 49% female), 74 (18%) were determined to be frail. Adjusted mean total costs were $6,397 higher for frail patients ($78,823 vs $72,425, p = 0.042) compared with nonfrail. Higher total costs were driven by department-level charges associated with longer in-hospital length of stay (7.6 vs 3.3 days, p <0.001): room, physical therapy, pharmacy, laboratory, supply, and imaging services. Providers must address frailty proactively to salvage the benefit associated with TAVI.

Impact of chronic thrombocytopenia on in-hospital outcomes and healthcare resource utilization after transcatheter aortic valve replacement.

BACKGROUND: There is little data on the impact of chronic thrombocytopenia (CTP) on outcomes after transcatheter aortic valve repair (TAVR). Most studies are from single centers and mostly focused on postprocedure thrombocytopenia. OBJECTIVES: This study sought to report on the impact of CTP (>1 year) on in-hospital outcomes and healthcare resource utilization after TAVR. METHODS: From the National Inpatient Sample (NIS) between 2012 and 2015, we identified patients with CTP who underwent TAVR. A 1:1 propensity-matched cohort was created to examine in-hospital outcomes in patients with and without CTP. The primary outcome was in-hospital mortality. Secondary outcomes included postprocedure complications, length of stay, total cost, and discharge disposition. RESULTS: A matched pair of 4,300 patients with and without CTP were identified. Patients with CTP had higher in-hospital mortality as compared to no CTP patients (6.0 vs. 3.3%, p-value .007), increased postprocedure hemorrhage, platelet and blood transfusion, vascular complications, postop sepsis, and acute kidney injury. With regards to resource utilization, CTP patients had a longer length of stay, higher total cost and were more likely to be discharged to a facility (34.1 vs. 27.6%) other than home (All, p-value <.001). Subanalysis, however, revealed this difference in resource utilization was seen when patients developed postprocedure complications. CONCLUSION: This study demonstrated higher risk of in-hospital mortality, perioperative complications, and healthcare resource utilization in patients with baseline CTP undergoing TAVR. Further studies are required to investigate ways to improve the management of these patients.

Episode Payments for Transcatheter and Surgical Aortic Valve Replacement.

BACKGROUND: Aortic stenosis is the most common valvular heart disease in the United States. Transcatheter aortic valve replacement (TAVR) is increasingly being adopted as an alternative to surgical aortic valve replacement (SAVR). In an era of value-based payment reform, our objective was to better understand the economic impact of the use of TAVR and SAVR in the United States. METHODS AND RESULTS: We performed a retrospective cohort study of Medicare beneficiaries who underwent TAVR or SAVR between 2012 and 2015. Using claims from a 20% sample of national fee-for-service Medicare beneficiaries, we calculated episode payments for patients who underwent aortic valve replacement from 90 days before aortic valve replacement through 90 days after hospital discharge. Among 18 804 eligible patients, 6455 underwent TAVR (34.3%), and 12 349 underwent SAVR (65.7%). After adjustment for patient characteristics, episode payments for TAVR were ≈7% lower than for SAVR (TAVR, $55 545 [95% CI, $54 643-56 446] versus $59 467 [95% CI, $58 723-60 211]; P<0.001). Patients with TAVR had higher preprocedural payments, but lower payments during and after the index hospitalization for the procedure. Episode payments increased with increasing comorbidity score for patients undergoing TAVR or SAVR (rate ratio, 1.16 [95% CI, 1.15-1.17]; P<0.001); however, this association was stronger for SAVR (rate ratio, 1.18 [95% CI, 1.17-1.19]) than for TAVR (rate ratio, 1.11 [95% CI, 1.11-1.12]; P<0.001 for interaction). Thus, differences in episode payments between TAVR and SAVR were greatest for the sickest patients but much less in healthier patients. CONCLUSIONS: TAVR is associated with lower episode payments than SAVR. However, episode payments for TAVR are less influenced by patient comorbidity. Therefore, as TAVR is increasingly used in patients with better baseline health status, the economic advantages of TAVR relative to SAVR may diminish.

Propensity Matched Analysis Comparing Conscious Sedation Versus General Anesthesia in Transcatheter Aortic Valve Implantation.

Conscious sedation (CS) has been increasingly utilized in transcatheter aortic valve implantation (TAVI). We aim to compare safety, efficacy, efficiency, and direct cost outcomes of patients who underwent TAVI with general anesthesia (GA) to those with CS. Records for all adult patients undergoing transfemoral TAVI at our institution between February 2012 and September 2018 were retrospectively screened. Patients were grouped by anesthesia treatment (GA or CS) and propensity matched. Safety (in-hospital and 30-day mortality, in-hospital and 30-day stroke, cardiac arrest, need for permanent pacemaker, and composite bleed/vascular adverse events), efficacy (follow-up echocardiographic findings), efficiency (procedure duration, fluoroscopy time, radiation dose, intensive care unit (ICU) stay, hospital length-of-stay, and discharge to home), and direct cost outcomes were compared. A total of 589 patients met our inclusion criteria. Propensity matching yielded 154 GA patients and 154 CS patients. There were no differences in the safety outcomes of in-hospital or 30-day mortality, in-hospital or 30-day stroke, cardiac arrest, and need for permanent pacemaker between GA and CS groups. There was a significant reduction in composite bleeding/vascular events in the CS group (8.4% vs 19.5%, p < 0.01). There were no differences in the follow-up echocardiograms with respect to aortic valve area, left ventricular ejection fraction, and incidence of moderate or severe aortic regurgitation. The CS group had shorter procedural fluoroscopy times and radiation dose, shorter length-of-stay and ICU stay, with similar procedural duration. CS patients were more likely to be discharged to home (59.7% vs 74.7%, p < 0.01). Total direct costs for CS were decreased in almost every departmental category, with a mean 10.4% reduction in overall direct costs (p < 0.001). In conclusion, TAVI with CS is associated with less bleeding and vascular events, lower procedural radiation exposure, reduced length of hospitalization and ICU stay, and lower direct costs in comparison with TAVI with GA. These outcomes occur without sacrificing procedural efficacy or safety.

Racial/Ethnic Disparities in Patients Undergoing Transcatheter Aortic Valve Replacement: Insights from the Healthcare Cost and Utilization Project's National Inpatient Sample.

PURPOSE: To identify racial/ethnic disparities in utilization rates, in-hospital outcomes and health care resource use among Non-Hispanic Whites (NHW), African Americans (AA) and Hispanics undergoing transcatheter aortic valve replacement (TAVR) in the United States (US). METHODS AND RESULTS: The National Inpatient Sample database was queried for patients ≥18 years of age who underwent TAVR from 2012 to 2014. The primary outcome was all-cause in hospital mortality. A total of 36,270 individuals were included in the study. The number of TAVR performed per million population increased in all study groups over the three years [38.8 to 103.8 (NHW); 9.1 to 26.4 (AA) and 9.4 to 18.2 (Hispanics)]. The overall in-hospital mortality was 4.2% for the entire cohort. Race/ethnicity showed no association with in-hospital mortality (P > .05). Though no significant difference were found between AA and NHW in any secondary outcome, being Hispanic was associated with higher incidence of acute myocardial infarction (aOR = 2.02; 95% CI, 1.06-3.85; P = .03), stroke/transient ischemic attack (aOR = 1.81; 95% CI, 1.04-3.14; P = .04), acute kidney injury (aOR = 1.65; 95% CI, 1.23-2.21; P < .01), prolonged length of stay (aOR = 1.18; 95% CI, 1.08-1.29; P < .01) and higher hospital costs (aOR = 1.27; 95% CI, 1.18-1.36; P < .01). CONCLUSION: There are significant racial disparities in patients undergoing TAVR in the US. Though in-hospital mortality was not associated with race/ethnicity, Hispanic patients had less TAVR utilization, higher in-hospital complications, prolonged length of stay and increased hospital costs.

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.