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.

Cost-Effectiveness of Transcatheter Versus Surgical Aortic Valve Replacement in Patients With Severe Aortic Stenosis at Intermediate Risk.

BACKGROUND: In patients with severe aortic stenosis (AS) at intermediate surgical risk, treatment with transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR) results in similar rates of death or stroke at 2 years. Whether TAVR is cost-effective compared with SAVR for intermediate-risk patients remains uncertain. METHODS: Between 2011 and 2014, 3110 intermediate-risk AS patients were treated with TAVR or SAVR in the PARTNER 2 trial (Placement of Aortic Transcatheter Valves 2). A total of 2032 patients were randomized to receive TAVR using the SAPIEN XT valve (XT-TAVR) or SAVR in the PARTNER 2A trial, whereas the PARTNER S3i registry included an additional 1078 patients treated with TAVR using the SAPIEN 3 valve (S3-TAVR), which offers a lower delivery profile and sealing skirt designed to reduce paravalvular regurgitation compared with XT-TAVR. Procedural costs were estimated using measured resource utilization. Other in-trial costs were assessed by linkage of trial data with Medicare claims (n=2333) or by linear regression models for unlinked patients (n=682). Health utilities were estimated using the EQ-5D at baseline and 1, 12, and 24 months. Using a Markov model informed by in-trial costs, utilities, and survival data, lifetime cost-effectiveness from the perspective of the US healthcare system was estimated in terms of cost per quality-adjusted life-year gained. RESULTS: Although procedural costs were ≈$20 000 higher with TAVR than SAVR, total cost differences for the index hospitalization were only $2888 higher with XT-TAVR ( P=0.014) and were $4155 lower with S3-TAVR ( P<0.001) owing to reductions in length of stay with TAVR. Follow-up costs were significantly lower with XT-TAVR (Δ=-$9304; P<0.001) and S3-TAVR (Δ=-$11 377; P<0.001) than with SAVR. Over a lifetime horizon, TAVR was projected to lower total costs by $8000 to $10 000 and to increase quality-adjusted survival by 0.15 to 0.27 years. XT-TAVR and S3-TAVR were found to be economically dominant compared with SAVR in 84% and 97% of bootstrap replicates, respectively. CONCLUSIONS: Among intermediate-risk AS patients, TAVR is projected to be economically dominant from the perspective of the US healthcare system by providing both greater quality-adjusted life expectancy and lower long-term costs than SAVR. If long-term data demonstrate comparable late mortality with TAVR and SAVR, these findings suggest that TAVR might be the preferred treatment strategy for intermediate-risk AS patients based on both clinical and economic considerations. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov . Unique identifier: NCT01314313.

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.

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.

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.

Incremental cost and length of stay associated with postprocedure delirium in transcatheter and surgical aortic valve replacement patients in the United States.

OBJECTIVES: To explore the impact of post-procedure delirium on resource utilization following transcatheter and surgical aortic valve replacement (TAVR and SAVR, respectively). BACKGROUND: Postprocedure delirium is associated with worse long-term survival after TAVR and SAVR. However, its effect on resource utilization has been understudied. METHODS: Using the 2015 Medicare Provider Analysis and Review File (MedPAR), we retrospectively analyzed elderly (≥80 years) Medicare beneficiaries receiving either SAVR or endovascular TAVR in the United States. Multivariate regression models estimating hospitalization cost and length of stay (LoS) were adjusted for patient demographics, comorbidities, and nondelirium complications. RESULTS: A total of 21,088 discharges were available for analysis (12,114 TAVR and 8,974 SAVR). TAVR patients were older (87 ± 3.8 vs. 84 ± 2.7 years; P < 0.001) with a higher comorbidity burden (Charlson index 3.0 ± 1.8 vs. 2.1 ± 1.7; P < 0.0001). Despite this, fewer TAVR patients (1.6%) experienced postoperative delirium during the index hospitalization compared to surgical patients (3.6%; P < 0.0001). Delirium was associated with a 4.16 [3.51-4.81] day longer hospital LoS and $15,592 ($12,849-$18,334) higher incremental hospitalization cost. When stratified by treatment approach, the adjusted incremental cost of delirium was +$13,862 ($9,431-$18,292) with TAVR and +$16,656 ($13,177-$20,136) with SAVR with an additional hospital LoS of +3.39 (2.34-4.43) days and +4.63 (3.81-5.45) days for TAVR and SAVR, respectively. CONCLUSIONS: Postprocedure delirium is associated with significantly increased hospitalization costs and LoS following AVR. TAVR was associated with a lower postoperative delirium rate compared to SAVR. Post-TAVR delirium may be associated with less resource consumption than post-SAVR delirium.

Comparative outcomes of transcatheter aortic valve replacement in African American and Caucasian patients with severe aortic stenosis.

BACKGROUND: Racial disparities in cardiovascular care have been extensively investigated. The introduction of transcatheter aortic valve replacement (TAVR) revolutionized the treatment of aortic stenosis (AS) in the last decade. Whether a racial disparity in the utilization and outcome of TAVR exists is unknown. METHODS: We utilized the nationwide inpatient sample (NIS) to compare utilization rates, and in-hospital outcomes of Caucasians and African American (AA) patients who underwent TAVR between August 2011 and December 2014. RESULTS: A total of 7,176 patients (6870 Caucasians, 95.7%) and (306 AAs, 4.3%) were included in this analysis. Among patients who underwent aortic valve replacement between 2011 and 2014, the rates of TAVR utilization increased from 0.32% to 7.6% in AAs and from 0.4% to 8.8% in Caucasians. In propensity-matched cohorts of patients (n = 300 Caucasians and n = 300 AAs), in-hospital mortality was similar (3.7% and 3.3%, respectively, P = 0.99). Also, rates of key complications including stroke, permanent pacemaker implantation (PPMI), vascular complications, acute kidney injury, new dialysis, blood transfusion, and tamponade were similar in both races. There was also no significant difference between Caucasians and AAs with regards to length of stay, cost of hospitalization, and intermediate care facility utilization. CONCLUSIONS: There was no significant difference in the utilization rates, in-hospital outcomes, and cost of TAVR between Caucasians and AA patients in contemporary US practice. Further comparative studies of surgical and TAVR in AAs and other racial minorities are warranted.

In-hospital outcomes of transcatheter versus surgical aortic valve replacement in end stage renal disease.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) is an alternative to surgical aortic valve replacement (SAVR) for patients with severe symptomatic aortic stenosis (AS) who are at intermediate and high risk for surgery. Commercial use of TAVR has expanded to patients with end stage renal disease (ESRD). OBJECTIVES: Compare in-hospital outcomes of TAVR versus SAVR in ESRD patients requiring hemodialysis (HD). METHODS: ESRD patients on HD undergoing TAVR (n = 328) or SAVR (n = 697) between 2012 and 2014 were identified in the National Inpatient Sample (NIS). Propensity-score matching method was used to minimize selection bias. Baseline characteristics and in-hospital outcomes were compared. RESULTS: TAVR patients were older (75.3 vs. 61.6 years, P < 0.001) and had more comorbidities, including congestive heart failure (16.2% vs. 7.5%), diabetes mellitus (28.4% vs. 22.5%), chronic lung disease (27.7% vs. 20.4%), and peripheral vascular disease (35.1% vs. 21.2%). Propensity-score matching yielded 175 pairs of patients matched on 30 baseline covariates. Overall in-hospital mortality was high (9.9%) and similar between TAVR and SAVR (8% vs. 10.3%, P = 0.58). TAVR was associated with shorter length of stay (LOS) (8 vs. 14 days, P < 0.001), lower hospitalization cost ($276,448 vs. $364,280, P = 0.01), lower in-hospital complications (60.6% vs. 76%, P = 0.003), and higher rate of home discharge (31.4% vs. 17.7%, P = 0.004) compared with SAVR. CONCLUSIONS: Regardless of treatment modality, patients with AS on HD have high in-hospital mortality. TAVR and SAVR have comparable in-hospital mortality in this population. However, TAVR is associated with shorter LOS, lower hospitalization costs, lower in-hospital complications, and higher rates of home discharge.

Outcomes and readmissions after transcatheter and surgical aortic valve replacement in patients with cirrhosis: A propensity matched analysis.

BACKGROUND: The data on the comparative outcomes and readmissions after transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR) in patients with cirrhosis are limited. We compared mortality, complications, discharge disposition, 30-day readmission rates, length of stay, and cost of hospitalization in cirrhotic patients undergoing TAVR and SAVR. METHODS: The National Inpatient Sample (NIS) and the National Readmission Database (NRD) were used for the study. The International Classification of Diseases-9th version was used to define cohorts of patients undergoing TAVR and SAVR. Patients undergoing concomitant other valve or coronary bypass surgery were excluded. Propensity-score matching was used to compare the outcomes between the groups. RESULTS: From 2012 to 2014, a total of 126 and 157 patients with cirrhosis underwent TAVR and SAVR, respectively. Of the 283 patients, 16 (5.7%) died during the same hospitalization. We found 345 patients with cirrhosis who had undergone an aortic valve replacement (156 with TAVR, and 189 with SAVR) in the 2013 and 2014 NRD. On propensity matching, there were no significant differences between the in-hospital mortality, readmissions, hospitalization costs, and discharges to home within the TAVR and SAVR groups. However, post-procedure length of stay (6.3 vs. 10.2 days; P < 0.001) and blood transfusion rates (22% vs. 58%; P < 0.001) were significantly lower in TAVR patients. CONCLUSIONS: Cirrhotic patients undergoing TAVR has high, but similar mortality and 30-day readmission rates when compared to SAVR; however, has shorter length of stay and lower blood transfusion rates.

Hospital outcomes of transcatheter versus surgical aortic valve replacement in female in the United States.

OBJECTIVES: To assess the in-hospital mortality and complications in female between transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR). BACKGROUND: Female is one of the risk factors for increased adverse events in cardiac surgery. METHODS AND RESULTS: Nationwide Inpatient Sample database was queried from 2011 to 2014 for patients who underwent TAVR or SAVR in female patients. The primary endpoint was in-hospital all-cause mortality and second endpoints were perioperative complications. We performed a propensity score analysis to calculate the adjusted odds ratio (OR) for each outcome. Patients who had concomitant cardiac surgery and those who had TAVR or SAVR mainly for aortic regurgitation were excluded. Our query from 2011 to 2014 resulted in a total of 3,067 TAVR and 18,594 SAVR in female patients. TAVR patients were in general elder and had a higher burden of comorbidities. The primary endpoint was similar between TAVR and SAVR (4.2% vs. 3.9%, OR 1.0, P = 0.89). Compared to SAVR, female TAVR patients had less hemorrhage requiring transfusion (12% vs. 21%, OR 0.41, P < 0.001), perioperative cardiac arrest and nonfatal myocardial infarction (9.8% vs. 17%, OR 0.38, P < 0.001), respiratory complication (1.6% vs. 4.4%, OR 0.28, P < 0.001), post-op sepsis (1.7% vs. 2.9%, OR 0.65, P = 0.03), acute myocardial infarction (3.0% vs. 4.9%, OR 0.60, P < 0.001), and acute kidney injury (15% vs. 18%, OR 0.62, P < 0.001). Conversely, female TAVR patients had significantly increased risk of new pacemaker implantation (11% vs. 5.9%, OR 1.7, P < 0.001) and use of extracorporeal membrane oxygenation (0.66% vs. 0.24%, OR 2.8, P < 0.001). TAVR patients had less nonroutine discharge. The median hospital cost was significantly higher in TAVR than SAVR (median $51,274 vs. $43,677, P < 0.001) but the length of stay was shorter (mean 7.8 days vs. 10.5 days). CONCLUSIONS: TAVR may be a better option for those patients with underlying comorbidities that predispose them at higher risk for complications that was less observed in TAVR group. However, higher cost and increased risk of need for extracorporeal membrane oxygenation, although rare, should be taken into consideration upon deciding the optimal mode for aortic valve replacement.

Hospital cost savings and other advantages of sutureless vs stented aortic valves for intermediate-risk elderly patients.

PURPOSE: To evaluate and compare the clinical outcomes and hospital costs of using sutureless aortic valves vs conventional stented aortic valves. METHODS: Between 2007 and 2011, 52 elderly patients undergoing aortic valve replacement for aortic stenosis in our center had a sutureless valve inserted. From among 180 patients who had a stented valve inserted during the same period, 52 patients were matched to the sutureless group, based on age, gender, and operation type. We compared clinical outcomes and hospital costs between the two groups. RESULTS: The sutureless group had a higher Euroscore (logistic Euroscore I) risk (12.8 vs 9.7; p = 0.02), with significantly shorter aortic cross-clamp (ACC) time (p < 0.01), cardiopulmonary bypass (CPB) time (p < 0.01), intensive care unit stay (p < 0.01), intubation time (p < 0.01), and overall hospital stay (p = 0.05). The sutureless group also revealed a significant hospital cost saving of approximately 8200€ (p = 0.01). CONCLUSIONS: The clinical and hemodynamic outcomes of using the sutureless bioprosthesis were excellent. The reduced ACC and CPB times had a favorable effect on the duration of intubation and intensive care stay, resulting not only in faster recovery and discharge home, but also in a significant hospital cost reduction.

Influence of same-day admission on outcomes following transcatheter aortic valve replacement.

BACKGROUND: Since elective transcatheter aortic valve replacements (TAVRs) can be performed on the day of admission, i.e., Day 0, or on the next day of admission, i.e., Day 1, we sought to investigate if there is an advantage to either approach. METHODS: We performed a retrospective cohort study, using the Healthcare Cost and Utilization Project's Nationwide Inpatient Sample database of 2012 and identified subjects undergoing endovascular (Transfemoral/Transaortic) TAVRs using the ICD-9-CM procedure code of 35.05. The cohort was divided based on the day of the TAVR performed, i.e., Day 0 or 1. The cost of the hospitalization and length of stay were the primary outcomes, with in-hospital mortality and procedural complications as the secondary outcomes. We identified a total of 843 TAVRs. Propensity matched models were created. The mean age of the study cohort was 82 years. RESULTS: In a propensity-matched dataset, TAVRs performed on Day 0 were associated with a lower cost ($51,126 ± 1184 vs $57,703 ± 1508, p < 0.0001) and length of stay (mean days, standard error: 5.87 ± 0.25 vs 7.20 ± 0.29, p < 0.001) compared to Day 1. In-hospital mortality plus complication rates were relatively similar with no difference between Days 0 and 1 (31.5% vs 34.1%, p = 0.47, respectively). CONCLUSIONS: Endovascular TAVRs performed on the same day of admission are associated with lower hospitalization costs and length of stay, and similar mortality and complication rates compared to those performed on the next day of admission.

Health-related quality of life after transcatheter or surgical aortic valve replacement in high-risk patients with severe aortic stenosis: an updated review of literature.

Recent trials have highlighted the comparable mortality benefits and durability of the results for patients with severe aortic stenosis (AS) and high surgical risk managed with either transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (AVR). Various national guidelines and international regulatory bodies have approved TAVR, thereby leading to potential wide usage and dissemination of this technique worldwide. Quality-of-life outcomes, in spite of being an important measure of success and acceptability of the procedure, have not been publicized as extensively. For high risk patients with severe AS, implementation of TAVR has resulted in comparable survival, but different and novel adverse events compared with AVR. We present an updated review focusing on the quality-of-life outcomes and issues with this new and important procedural approach.

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.

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.

Aortic valve replacement today: Outcomes, costs, and opportunities for improvement.

The introduction of transcatheter aortic valve replacement (TAVR) just two decades ago has transformed the treatment of severe symptomatic aortic stenosis. TAVR has not only extended the option of aortic valve replacement to patients deemed ineligible for surgery, it has also demonstrated similar or better short- and intermediate-term clinical outcomes compared with surgical aortic valve replacement (SAVR) in patients at all levels of surgical risk. These benefits have been achieved with similar or lower costs compared with SAVR, at least in the first 1-2 years for intermediate- and low-risk patients. Longer-term data will further inform clinical and shared decision-making. SUMMARY FOR ANNOTATED TABLE OF CONTENTS: In just over two decades, transcatheter aortic valve replacement has emerged as a frontline approach for appropriately selected patients with severe aortic stenosis. A growing body of evidence documents similar or better clinical outcomes and cost-effectiveness for transcatheter compared with surgical aortic valve replacement. Whether the mode is transcatheter or surgical, aortic valve replacement remains underutilized in patients with clear indications for intervention.

Transcatheter aortic valve implantation with and without mitral stenosis - A National Readmission Database study.

INTRODUCTION: Mitral valve stenosis (MS) can be concomitantly present in patients undergoing Transcatheter Aortic Valve Implantation (TAVI). Some studies have reported up to one-fifth of patients who underwent TAVI also have MS. The relationship between mitral stenosis and TAVI has led to concerns regarding increased adverse cardiac outcomes during and after the procedure. METHODS: The Nationwide Readmission Database (NRD 2016-2019) was utilized to identify TAVI patients with MS with ICD-10-CM codes. The primary outcome was a 30-day readmission rate. Secondary outcomes included predictors of all-cause readmissions, length of stay, and total hospitalization cost. We assessed readmission frequency with a national sample weighed at 30 days following the index TAVI procedure. Unadjusted and adjusted odds ratios were analyzed for in-hospital outcomes using univariate and multivariate logistic regression for study cohorts. RESULTS: A total of 217,147 patients underwent TAVI procedures during the queried time period of the study. Of these patients, 2140 (0.98 %) had MS. The overall 30-day all-cause readmission rate for the study cohort was 12.4 %. TAVI patients with MS had higher rates of 30-day readmissions (15.8 % vs 12.3 %, aOR 1.22, CI: 1.03-1.45, P < 0.01). Additionally, TAVI patients with MS had longer lengths of hospital stay during index admissions (5.7 vs. 4.3 days), along with higher total hospitalization costs ($55,157 vs. $50,239). In contrast, in-hospital mortality during index TAVI admission did not differ significantly between the two groups, although there was a trend toward higher mortality in the MS group (2.1 % vs. 1.5 %). Among the TAVI MS cohort, patients admitted on weekends (aOR: 1.11, 95 % CI: 1.02-1.22, P = 0.01), admitted to non-metropolitan hospitals (aOR: 1.29, 95 % CI: 1.11-1.66, P = 0.04) and presence of co-morbidities such as atrial fibrillation (AF)/flutter (aOR: 1.24, 95 % CI: 1.16-1.32, P < 0.01), chronic obstructive pulmonary disease (COPD) (aOR: 1.16, 95 % CI: 1.11-1.22, P < 0.01), prior stroke (aOR: 1.09, 95 % CI: 1.03-1.14, P < 0.01), chronic kidney disease (CKD) ≥3 (aOR: 1.16, 95 % CI: 1.11-1.22, P < 0.01), end-stage renal disease (ESRD) (aOR: 1.75, 95 % CI: 1.61-1.90, P < 0.01), and anemia (aOR: 1.23, 95 % CI: 1.18-1.28, P < 0.01) were associated with increased odds of readmission. CONCLUSION: Concomitant MS in patients undergoing TAVI is associated with higher readmission rates and total hospital costs. This can contribute significantly to healthcare-related burdens. Further studies are required to evaluate in-hospital outcomes and predictors of readmission in patients undergoing TAVI with the presence of concomitant MS.

Cost-effectiveness of transcatheter aortic valve replacement compared with standard care among inoperable patients with severe aortic stenosis: results from the placement of aortic transcatheter valves (PARTNER) trial (Cohort B).

BACKGROUND: In patients with severe aortic stenosis who cannot have surgery, transcatheter aortic valve replacement (TAVR) has been shown to improve survival and quality of life compared with standard therapy, but the costs and cost-effectiveness of this strategy are not yet known. METHODS AND RESULTS: The PARTNER trial randomized patients with symptomatic, severe aortic stenosis who were not candidates for surgery to TAVR (n=179) or standard therapy (n=179). Empirical data regarding survival, quality of life, medical resource use, and hospital costs were collected during the trial and used to project life expectancy, quality-adjusted life expectancy, and lifetime medical care costs to estimate the incremental cost-effectiveness of TAVR from a US perspective. For patients treated with TAVR, mean costs for the initial procedure and hospitalization were $42 806 and $78 542, respectively. Follow-up costs through 12 months were lower with TAVR ($29 289 versus $53 621) because of reduced hospitalization rates, but cumulative 1-year costs remained higher ($106 076 versus $53 621). We projected that over a patient's lifetime, TAVR would increase discounted life expectancy by 1.6 years (1.3 quality-adjusted life-years) at an incremental cost of $79 837. The incremental cost-effectiveness ratio for TAVR was thus estimated at $50 200 per year of life gained or $61 889 per quality-adjusted life-year gained. These results were stable across a broad range of uncertainty and sensitivity analyses. CONCLUSIONS: For patients with severe aortic stenosis who are not candidates for surgery, TAVR increases life expectancy at an incremental cost per life-year gained well within accepted values for commonly used cardiovascular technologies. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00530894.

Transfemoral aortic valve implantation: bleeding events, related costs and outcomes.

Although less invasive then SAVR, TAVI is associated with a significant rate of access site and non-access site bleeding. These complications are major determinants of therapy outcome, however, the economic consequences are not well defined. The purpose of this study was to determine the relationship between bleeding, in-hospital resource utilization and costs among patients undergoing transfemoral aortic valve implantation (TF-AVI) at a representative university hospital in Germany. Between February 2010 and December 2011, we prospectively enrolled 60 consecutive patients undergoing TAVI using a 18F transfemoral approach at our institution. The relationship between overt bleeding (OVB), defined according to the definitions provided by the Valve Academic Research Consortium, in-hospital resource utilization and in-hospital costs was investigated. The mean age was 82 (±6) years, 53% were female and the mean EuroScore was 17.2% (±8, 7). Thirty-eight percent (23/60) of the patients had an OVB following TF-AVI procedure. In-hospital mortality was 8.7% in the OVB patients (2/23) and 2.7% among patients without any OVB (1/37; NOVB), which was not statistically significant (p = 0.3). The total length of stay (LOS) of patients with and without bleeding complication were 15.0 ± 6.4 and 10.4 ± 5.1 days, respectively (p < 0.01). Time spent on ICU in the OVB group was twice as long as compared to the NOVB group (120.5 ± 98.5 min vs. 63.6 ± 26.5 min, p < 0.01). Consequently, in-hospital costs were statistically significant higher in OVB patients (40.051 ± 9.293 vs. 33.625 ± 4.368, p < 0.01). Bleeding is associated with increased resource use and in-hospital costs among TF-AVI patients. Our data indicates that strategies reducing bleeding risk may have the potential to generate important in-hospital costs reductions in TF-AVI patients.