Savings associated with surgical aortic valve replacement with a RESILIA tissue valve based on seven-year COMMENCE trial results.

BACKGROUND: Bioprostheses with RESILIA tissue demonstrate a reduction in calcification and improve health outcomes in pre-clinical and clinical studies. Prior economic analyses which relied on 5 years of evidence from the COMMENCE trial demonstrate financial savings for RESILIA tissue valves relative to mechanical valves after surgical aortic valve replacement (SAVR). Given the recent release of 7-year COMMENCE data, this economic evaluation updates the estimate for long-run savings of bioprosthetic valves with RESILIA. METHODS: Simulation models estimated disease progression across two hypothetical SAVR cohorts (tissue vs. mechanical) of 10,000 patients each in the US. The primary comparison calculated the SAVR-related expenditures associated with each valve type ($US, 2023). Health outcome probabilities were based on the COMMENCE trial though year 7 and projected for an additional 8 years based on prior studies of tissue and mechanical SAVR. Costs for key outcomes (mortality, reoperation, bleeding, thromboembolism, endocarditis) and anticoagulant monitoring were sourced from the literature. Incidence rates of health outcomes associated with mechanical valves relied on relative risks of tissue valve versus mechanical valve patients. RESULTS: Seven-year savings are $13,415 (95% CI = $10,472-$17,321) per patient when comparing RESILIA versus mechanical SAVR. Projected 15-year savings were $23,001 ($US, 2023; 95% CI = $17,802-$30,421). Most of the 15-year savings are primarily attributed to lower anti-coagulation monitoring costs ($21,073 in ACM savings over 15 years), but lower bleeding cost (savings: $2,294) and thromboembolism-related expenditures (savings: $852) also contribute. Reoperation and endocarditis expenditures were slightly larger in the RESILIA cohort. If reoperation relative risk reverts from 1.1 to 2.2 (the level in legacy tissue valves) after year 7, savings are $18,064. RESILIA SAVR also reduce costs relative to legacy tissue valves. CONCLUSION: Patients receiving RESILIA tissue valves are projected to have lower SAVR-related health expenditures relative to mechanical and legacy tissue valves.

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.

Mortality and resource utilization in surgical versus transcatheter repeat mitral valve replacement: A national analysis.

BACKGROUND: Transcatheter mitral valve replacement (TMVR) has garnered interest as a viable alternative to the traditional surgical mitral valve replacement (SMVR) for high-risk patients requiring redo operations. This study aims to evaluate the association of TMVR with selected clinical and financial outcomes. METHODS: Adults undergoing isolated redo mitral valve replacement were identified in the 2016-2020 Nationwide Readmissions Database and categorized into TMVR or SMVR cohorts. Various regression models were developed to assess the association between TMVR and in-hospital mortality, as well as additional secondary outcomes. Transseptal and transapical catheter-based approaches were also compared in relation to study endpoints. RESULTS: Of an estimated 7,725 patients, 2,941 (38.1%) underwent TMVR. During the study period, the proportion of TMVR for redo operations increased from 17.8% to 46.7% (nptrend<0.001). Following adjustment, TMVR was associated with similar odds of in-hospital mortality (AOR 0.82, p = 0.48), but lower odds of stroke (AOR 0.44, p = 0.001), prolonged ventilation (AOR 0.43, p<0.001), acute kidney injury (AOR 0.61, p<0.001), and reoperation (AOR 0.29, p = 0.02). TMVR was additionally correlated with shorter postoperative length of stay (pLOS; ß -0.98, p<0.001) and reduced costs (ß -$10,100, p = 0.002). Additional analysis demonstrated that the transseptal approach had lower adjusted mortality (AOR 0.44, p = 0.02), shorter adjusted pLOS (ß -0.43, p<0.001), but higher overall costs (ß $5,200, p = 0.04), compared to transapical. CONCLUSIONS: In this retrospective cohort study, we noted TMVR to yield similar odds of in-hospital mortality as SMVR, but fewer complications and reduced healthcare expenditures. Moreover, transseptal approaches were associated with lower adjusted mortality, shorter pLOS, but higher cost, relative to the transapical. Our findings suggest that TMVR represent a cost-effective and safe treatment modality for patients requiring redo mitral valve procedures. Nevertheless, future studies examining long-term outcomes associated with SMVR and TMVR in redo mitral valve operations, are needed.

Prevalence, mortality, cost, and disparities in transcatheter mitral valve repair and replacement in cancer patients: Artificial intelligence and propensity score national 5-year analysis of 7495 procedures.

INTRODUCTION: We conducted the first comprehensive evaluation of the therapeutic value and safety profile of transcatheter mitral edge-to-edge repair (TEER) and transcatheter mitral valve replacement (TMVR) in individuals concurrently afflicted with cancer. METHODS: Utilizing the National Inpatient Sample (NIS) dataset, we analyzed all adult hospitalizations between 2016 and 2020 (n = 148,755,036). The inclusion criteria for this retrospectively analyzed prospective cohort study were all adult hospitalizations (age 18 years and older). Regression and machine learning analyses in addition to model optimization were conducted using ML-PSr (Machine Learning-augmented Propensity Score adjusted multivariable regression) and BAyesian Machine learning-augmented Propensity Score (BAM-PS) multivariable regression. RESULTS: Of all adult hospitalizations, there were 5790 (0.004%) TMVRs and 1705 (0.001%) TEERs. Of the total TMVRs, 160 (2.76%) were done in active cancer. Of the total TEERs, 30 (1.76%) were done in active cancer. After the comparable rates of TEER/TMVR in active cancer in 2016, the prevalence of TEER/TMVR was significantly less in active cancer from 2017 to 2020 (2.61% versus 7.28% p < 0.001). From 2017 to 2020, active cancer significantly decreased the odds of receiving TEER or TMVR (OR 0.28, 95%CI 0.13-0.68, p = 0.008). In patients with active cancer who underwent TMVR/TEER, there were no significant differences in socio-economic disparities, mortality or total hospitalization costs. CONCLUSION: The presence of malignancy does not contribute to increased mortality, length of stay or procedural costs in TMVR or TEER. Whereas the prevalence of TMVR has increased in patients with active cancer, the utilization of TEER in the context of active cancer is declining despite a growing patient population.

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.

Long-term cost-effectiveness of transcatheter mitral valve repair in HF patients with secondary mitral regurgitation.

AIMS: The long-term cost-effectiveness of MitraClip in heart failure patients with secondary mitral regurgitation is still unclear. This study aimed to evaluate the long-term cost-effectiveness of MitraClip added to guideline-directed medical therapy vs. guideline-directed medical therapy alone in heart failure patients with secondary mitral regurgitation from the perspective of the healthcare systems of mainland China, the United Kingdom, Germany, and the United States. METHODS AND RESULTS: A two-stage (decision + Markov) model was built. Health utilities were defined by the New York Heart Association class, heart failure re-hospitalization, and death and were calculated based on the 5 year follow-up results of the Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation trial. Direct healthcare costs were derived from the nationally representative data. Future utilities and costs were discounted at country-specific rates. The primary outcome was the lifetime incremental cost-effectiveness ratio. The mean age of the base case in our model was 72.2 years. Over a lifetime horizon, treatment with MitraClip was associated with 829 fewer heart failure re-hospitalizations per 1000 treated patients. The MitraClip treatment was associated with incremental quality-adjusted life-year gains of 0.71, 0.76, 0.78, and 0.78, as well as incremental cost-effectiveness ratios of ¥468 462, £28 910, €26 045, and $71 199 per quality-adjusted life-year for a lifetime horizon in mainland China, the United Kingdom, Germany, and the United States, respectively. In probabilistic sensitivity analysis, 0.2%, 59.4%, 99.6%, and 84.7% of patients were cost-effective in mainland China, the United Kingdom, Germany, and the United States at the country-specific willingness-to-pay thresholds. CONCLUSIONS: MitraClip + guideline-directed medical therapy was cost-effective in heart failure patients with secondary mitral regurgitation in the United Kingdom, Germany, and the United States, but not in mainland China from the perspective of the national healthcare system.

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.

Readmission-related outcomes of surgical versus transcatheter aortic valve replacement in patients aged 65 or older with bicuspid aortic valve.

BACKGROUND: There continues to be debate regarding the superiority of transcatheter (TAVR) over surgical aortic valve replacement (SAVR) in patients with bicuspid aortic valves (BAV). We aimed to compare outcomes during readmissions in elderly patients with BAV who underwent SAVR or TAVR. METHODS: Patients 65 years or older with BAV who underwent TAVR or isolated SAVR were identified using the National Readmission Database from 2012 through 2018. We compared outcomes during readmissions within 90 days after discharge from the index surgery. Propensity score matching was performed to adjust the baseline differences. RESULTS: During the study period, 8555 and 1081 elderly patients with BAV underwent SAVR and TAVR, respectively. The number of patients who underwent TAVR went up by 179 % from 2012 to 2018. Propensity score matching yielded 573 patients in each group. A total of 111 (19.4 %) in the SAVR group and 125 (21.8 %) in the TAVR group were readmitted within 90 days after the index surgery (p = .31). The mortality during the readmissions within 90 days was equivalent between the two groups (0.9 % in the SAVR group vs. 3.2 % in the TAVR group, p = .22). However, the median hospital cost was approximately doubled in the TAVR group during the readmission (18,250 dollars vs. 9310 dollars in the SAVR group, p < .001). CONCLUSIONS: Readmission within 90 days was common in both groups. While the mortality during the readmissions after the surgery was equivalent between the two groups, hospital cost was significantly more expensive in the TAVR group.

Cost-effectiveness of transcatheter aortic valve implantation versus surgical aortic valve replacement in low surgical risk aortic stenosis patients.

BACKGROUND: The PARTNER 3 trial demonstrated clinical benefits of transcatheter aortic valve implantation (TAVI) with the SAPIEN 3 device, over surgical aortic valve replacement (SAVR) in patients with severe symptomatic aortic stenosis (sSAS) at low risk of surgical mortality. Using PARTNER 3 outcomes and Italy-specific costs data, this cost-utility analysis from the perspective of the Italian National Health System aimed to determine the cost-effectiveness of SAPIEN 3 TAVI versus SAVR in low risk sSAS patients in Italy. METHODS: A two-stage cost-utility model was developed to estimate changes in both direct healthcare costs and health-related quality of life using TAVI with SAPIEN 3 compared with SAVR. Early adverse events associated with TAVI were captured utilising the PARTNER 3 dataset. These data fed into a Markov model that captured longer-term outcomes of patients, following TAVI or SAVR intervention. RESULTS: Analysis findings estimated that TAVI with SAPIEN 3 offers benefits over SAVR in terms of increased quality-adjusted life years (QALYs) with only a small increase in costs, representing an incremental cost-effectiveness ratio/QALY gained of €2989 per patient. The results were robust, with TAVI with SAPIEN 3 remaining cost-effective across several scenarios and in probabilistic sensitivity analyses. CONCLUSIONS: This model demonstrated that TAVI with SAPIEN 3 is likely to be cost effective compared with SAVR for the treatment of patients with sSAS who are at low risk of surgical mortality. These findings can inform policy makers to facilitate policy development in Italy on intervention selection for this patient population.

Comparison of Transcatheter and Open Mitral Valve Repair Among Patients With Mitral Regurgitation.

In 2013, the Food and Drug Administration approved the first transcatheter mitral valve repair (TMVr) device for degenerative mitral regurgitation for patients at prohibitive surgical risk. To better understand contemporary utilization trends and outcomes, we reviewed hospitalizations, identified using International Classification of Diseases, Ninth Revision and International Classification of Diseases, Tenth Revision codes, in which the patient underwent TMVr or mitral valve repair (MVr) with a diagnosis of mitral regurgitation, without stenosis, from the National (Nationwide) Inpatient Sample from 2014 to 2017. We included 10,020 hospitalizations in which the patient underwent TMVr and 5845 in which the patient underwent MVr and assessed trends in demographic characteristics, patient comorbidities, total hospital charges, and outcomes. Transcatheter mitral valve repair experienced exponential growth, increasing from 150 to 5115 over the study period (P<.001 for trend), whereas MVr grew to a lesser degree. The median length of stay for TMVr decreased from 4 to 2 days; mortality declined from 3.3% to 1.6% (P<.001 for both). Both TMVr and MVr rates of discharge home increased over the study period. Total charges for TMVr increased from $149,582 to $178,109, whereas those for MVr increased to a lesser degree, from $149,426 to $157,146 (P<.001 for both). Discharge disposition, length of stay, and in-hospital mortality all exhibited favorable trends for both procedures. Caution must be exercised in direct comparisons between procedures as they target somewhat different populations. With expanded indications for TMVr, we anticipate further increases in procedural volume, although the effect on MVr remains unclear.

Safety, effectiveness and costs of percutaneous mitral valve repair: A real-world prospective study.

AIMS: Percutaneous mitral valve leaflet repair is a treatment option for some people with severe mitral valve regurgitation for whom conventional mitral valve surgery is clinically inappropriate. This study aimed to determine the safety, efficacy, and costs of percutaneous mitral valve leaflet repair, using the MitraClip device in a UK setting. METHODS AND RESULTS: This was a prospective, single-armed registry with a follow-up of 2 years that reported a range of procedural, clinical and patient-orientated outcomes. Registry data were linked to routine data sources to allow for more comprehensive follow up concerning mortality and healthcare resource use. The registry received data for 199 mainly elective patients with mixed mitral regurgitation aetiology. A MitraClip device was implanted in 187 patients (94%), with a procedural success rate of 86%, with 8% of patients having a serious in-hospital adverse event (including 5% mortality). Percutaneous mitral valve leaflet repair reduced mitral regurgitation from 100% MR grade ≥ 3+ to 7% at discharge. There were corresponding improvements in New York Heart Association functional class, reducing from 92% (class ≥ 3) at baseline to 18% at 6 weeks. There were significant improvements in generic and disease specific quality of life indicators up to 2 years. The all-cause mortality rate was estimated to be 12.7% (95% CI 7.5 to 17.7%) at 1 year. Percutaneous mitral valve leaflet repair was associated with reduced hospital readmissions and potential cost-savings in post-procedural care. CONCLUSION: This study shows that percutaneous mitral valve leaflet repair using MitraClip is a relatively safe and effective treatment in patients unable to tolerate surgery and has the potential to reduce ongoing healthcare costs in the UK.

Real-World Health-Economic Considerations Around Aortic-Valve Replacement in a Publicly Funded Health System.

Herein, we describe the unique interplay among biomedical ethics, principles of distributive justice, and economic theory to highlight the role of health technology assessments to compare therapeutic options for aortic valve replacement. From the perspective of the Canadian health care system, transcatheter aortic-valve implantation is associated with higher costs but also higher incremental health benefits compared with surgical aortic-valve replacement. At current willingness to pay thresholds, transcatheter aortic-valve replacement is likely cost effective across the spectrum of risk, from inoperable patients to those at low surgical risk. However, we highlight the nuances within each subgroup of surgical risk that merit careful consideration by the heart team. Moreover, incorporation of patients and their preferences in decision-making is key. In particular, in young, low-risk patients, there remains uncertainty regarding the optimal treatment, with unique concerns around valve durability, selection of valve prosthesis, and consideration for special procedures such as the Ross procedure. Nonetheless, current research suggests that, universally, patients prefer a less invasive approach compared with a more invasive approach. Finally, we highlight that there remain critical issues around timeliness of access to care and unacceptable geographic inequities across Canada. Further research into alternative funding mechanisms and integrated cross-sector care pathways is necessary to address these issues.

The Safety and Efficacy of Transcatheter Pulmonary Valve Replacement Combined with Electrophysiology Procedures.

The objective of this study was to evaluate the safety and efficacy of combining transcatheter pulmonary valve replacement (TPVR) and electrophysiology (EP) procedures. A retrospective review was undertaken to identify TPVR and EP procedures that were concomitantly performed in the cardiac catheterization laboratory at University of Iowa Stead Family Children's Hospital from January 2011 to October 2019. Procedural and follow-up data were compared between patients who underwent TPVR and EP procedures in the same setting to those who received TPVR or EP procedure separately and that were similar in age and cardiac anatomy. A total of 8 patients underwent combined TPVR and EP procedures. One patient was excluded due to lack of adequate control, leaving seven study subjects (57% female; median age at time of procedure 16 years). The median follow-up time was 11.5 months (range 2-36 months). Patients who received combined TPVR and EP had shorter recovery times (combined: median 18.9 h; IQR 18.35-19.5 vs separate: median 27.98 h; IQR 21.42-39.25; p-value 0.031), shorter hospital length of stay (combined: median 27.5 h; IQR 26.47-31.4 vs separate: median 38.4 h; IQR 33.42-51.50; p-value 0.016), and a 51% reduction in total hospital charges (combined: median $171,640; IQR 135.43-219.22 vs separate: median $333,560 IQR 263.20-400.98; p-value 0.016). There were no significant differences in radiation dose or procedure time between the combined and control groups. The median radiation time for those who had the combination procedure was 30.5 min [IQR 29.6-47.9], and the median dose area product was 215 mGy [IQR 158-935]. In conclusion, combining TPVR and EP procedures is feasible, safe, and economically advantageous.

Economic assessment of traditional surgical valve replacement versus use of transfemoral intervention in degenerative aortic stenosis.

INTRODUCTION: The aim of this study was to provide an economic assessment of interventional vs. surgical aortic valve replacement in the context of cost-effectiveness. Aortic stenosis represents the most common form of degenerative valvular heart diseases. As life expectancy increases, an even emerging prevalence is expected. Over decades, surgical replacement was considered as the method of choice. Up to one third of the patients were not eligible for surgery, as their estimated peri-operative risk was too high. In the early 2000s a catheter-based technique has been developed, being an alternative treatment option for patients, considered to be inoperable. EVIDENCE ACQUISITION: A systematic analysis of current literature was performed from September 2018 to December 2018. All suitable data in the field was obtained from Pubmed and Google/Google scholar. The search terms "TAVI AND costs," "TAVR and costs" and "aortic valve replacement AND costs" was entered in the search field, showing an overall amount of 317 publications. In a next step all obtained publications were screened by expert hand selection. EVIDENCE SYNTHESIS: Recently the Food and Drug Association (FDA) approved transcatheter aortic valve replacement (TAVR) in the low-risk setting. Nevertheless, concerns on the higher price remain. We performed an analysis of current literature on aortic stenosis and economic aspects. Out of 322 screened publications, 7 studies were found eligible by expert hand selection. Based on the predefined payment readiness of the analyzed healthcare system, TAVR appeared to have a slightly better cost effectiveness. Initial results within the early era seemed to be inconsistent. Recent publications showed, TAVR might be of more cost effectiveness when using the newest generation devices and a profound clinical experience is guaranteed. CONCLUSIONS: We assume, that TAVR will not only be the method of choice for the treatment of aortic stenosis in many patients. As the valves are getting cheaper, TAVR might even be superior to conventional heart surgery from an economic point of view.

Economic Analysis and Long-term Follow-up of Distant Referral for Degenerative Mitral Valve Repair.

BACKGROUND: Despite the superiority of mitral valve repair (MVr) over replacement for degenerative disease, repair rates vary widely across centers. Traveling to a mitral reference center (MRC) is 1 way to increase the odds of MVr. This study assessed the economic value (quality/cost) and long-term outcomes of distant referral to an MRC. METHODS: Among 746 mitral surgery patients between January 2011 and June 2013, low-risk patients with an ejection fraction greater than 40% undergoing isolated degenerative MVr were identified and included 26 out-of-state (DISTANT) and 104 in-state patients (LOCAL). Short- and long-term outcomes and institutional financial data (including travel expenses) were used to compare groups. National average and MRC-specific MVr rates, clinical outcomes, and marginal value of quality-adjusted life-years collected from The Society of Thoracic Surgeons database and Medicare estimates were used to perform a nationally representative cost-benefit analysis for distant referral. RESULTS: Age, ejection fraction, operative time, blood transfusions, and annuloplasty ring size did not differ between groups. Median charges were $76,022 for LOCAL and $74,171 for DISTANT (P = .35), whereas median payments (including travel expenses) were $57,795 for LOCAL and $58,477 for DISTANT (P = .70). Short- and long-term outcomes were similar between groups and median follow-up was 7.1 years. Estimated 5-year survival was 97% (96% for LOCAL and 100% for DISTANT; P = .24). Cost-benefit analysis showed a net benefit through distant referral to an MRC ranging from $436 to $6078 to the payer and $22,163 to $30,067 to the patient, combining for an estimated $22,599 to $32,528 societal benefit. CONCLUSIONS: These data suggest that distant referral to an MRC is achievable and reasonable.

Sources of Hospital Variation in Postacute Care Spending After Cardiac Surgery.

BACKGROUND: Postacute care is a major driver of cardiac surgical episode spending, but the sources of variation in spending have not been explored. The objective of this study was to identify sources of variation in postacute care spending within 90-days of discharge following coronary artery bypass grafting (CABG) and aortic valve replacement (AVR) and the relationship between postacute care spending and other postdischarge utilization. METHODS AND RESULTS: A retrospective analysis was conducted of public and private administrative claims for Michigan residents insured by Medicare fee-for-service and Blue Cross Blue Shield of Michigan/Blue Care Network commercial and Medicare Advantage plans undergoing CABG (n=11 208) or AVR (n=6122) in 33 nonfederal acute care Michigan hospitals between January 1, 2015 and December 31, 2018. Postacute care use was present in 9662 (86.2%) CABG episodes and 4242 (69.3%) AVR episodes, with respective mean (SD) 90-day spending of $4398±$6124 and $3465±$5759. Across hospitals, mean postacute care spending ranged from $3280 to $8186 for CABG and $2246 to $7710 for AVR. Inpatient rehabilitation and skilled nursing facility care accounted for over 80% of the variation spending between low and high postacute care spending hospitals. At the hospital-level, postacute care spending was modestly correlated across procedures and payers. Spending associated with readmissions, emergency department visits, and outpatient facility care was significantly different between low and high postacute care spending hospitals in CABG and AVR episodes. CONCLUSIONS: There was wide hospital variation in postacute care spending after cardiac surgery, which was primarily driven by differential use and intensity in facility-based postacute care. Optimizing facility-based postacute care after cardiac surgery offers unique opportunities to reduce potentially unwarranted care variation.

Use of an Aortic Valve Replacement Simulation Model to Understand Hospital Costs and Resource Utilization Associated With Rapid-deployment Valves.

PURPOSE: Aortic stenosis (AS) is the most common cause of adult valvular heart disease. In the past decade, minimally invasive surgery (MIS) to treat AS has gained popularity, especially if performed in combination with rapid deployment valves (RDVs), which shorten cross-clamp time (XCT). This study examines specific outcomes and related costs of aortic valve replacement (AVR) before and after the introduction of RDVs. METHODS: We used the AVR simulator, an economic model developed to correlate cost and resource utilization associated with the adoption of RDVs, to compare 2 scenarios: (1) a current scenario based on standard AVR practices and (2) a proposed scenario based on increasing use of RDVs and an MIS approach. Both scenarios involved 3 subgroups of patients treated with (1) conventional AVR, (2) MIS, and (3) AVR combined with a coronary artery bypass graft. The current scenario (status quo) involved patients treated with traditional biological valves, and the proposed scenario involved patients who underwent implantation with an RDV. The AVR simulator was fed with real-world input data to estimate complication rates and resource consumption in the proposed scenario. Real-world input data for this analysis were obtained from patients diagnosed with a symptomatic heart valve disease between 2015 and 2018, at Clinica-San-Gaudenzio, Novara, Italy. Lastly, the AVR simulator estimated hospital savings by comparing the 2 scenarios. FINDINGS: A total of 132 patients underwent implantation with a traditional biological valve, and 107 were treated with a commercial valve system. The RDV was associated with an increase of 52% of patients undergoing MIS, which generated a 6.1-h reduction of XCT and a total savings of €6695. RDVs also reduced intensive care unit (ICU) and hospital ward length of stay (LOS), leading to savings of €677 and €595 per patient, respectively. Mortality and blood transfusions also improved. The savings for the hospital (related to shorter XCT, hospital ward LOS, and ICU LOS) amounted to €144.111. Our findings were consistent with data gathered from our real-word setting, and results of a sensitivity analysis indicate that our findings were robust across different possible situations. IMPLICATIONS: Switching to RDVs and MIS procedures for AVRs was associated with a reduction of costs related to XCT, hospital ward LOS, and ICU LOS. Hospitals can upload literature- and experience-based clinical and cost values to the AVR simulator to estimate a hospital's performance with the introduction of RDVs compared with standard biological valves. This study was not randomized, so more extensive studies could confirm our results in the future.

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.

CardioMEMSTM System in the Daily Management of Heart Failure: Review of Current Data and Technique of Implantation.

INTRODUCTION: Heart failure (HF) leads to significant morbidity and mortality and imposes a large economic burden. Although there have been several advances in HF monitoring and management, HF-rehospitalization remains a significant problem. Remote monitoring of HF to detect early signs of decompensation has emerged in past years as an option to prevent or reduce the incidence of HF rehospitalization. The CardioMEMSTM HF system is a wireless pulmonary artery (PA) pressure monitoring system that detects changes in PA pressure and transmits data to the healthcare provider. Since changes in PA pressure happen early in the course of HF decompensation, the CardioMEMSTM system allows the provider to institute timely intensification of HF therapies to alter the course. In trial and registry data, the use of the CardioMEMSTM HF system has been associated with reduction in HF hospitalization, improvement in quality of life, symptoms, and physical activity. AREAS COVERED: This review will focus on the available data supporting its utilization in patients with HF. EXPERT OPINION: CardioMEMSTM is relatively safe and cost-effective, reduces heart failure hospitalization rates, and fits into intermediate to high-value medical care.

Relative Costs of Surgical and Transcatheter Aortic Valve Replacement and Medical Therapy.

BACKGROUND: The number of patients treated for aortic valve disease in the United States is increasing rapidly. Transcatheter aortic valve replacement (TAVR) is supplanting surgical aortic valve replacement (SAVR) and medical therapy (MT). The economic implications of these trends are unknown. Therefore, we undertook to determine the costs, inpatient days, and number of admissions associated with treating aortic valve disease with SAVR, TAVR, or MT. METHODS: Using the Nationwide Readmissions Database, we identified patients with aortic valve disease admitted 2012 to 2016 for SAVR, TAVR, and disease symptoms (congestive heart failure, unstable angina, non-ST-elevation myocardial infarction, syncope). Patients not undergoing SAVR or TAVR were classified as receiving MT. Beginning with the index admission, we estimated inpatient costs, days, and admissions over 6 months. RESULTS: Among 190 563 patients with aortic valve disease, the average aggregate 6-month inpatient costs were $59 743 for SAVR, $64 395 for TAVR, and $23 460 for MT. Mean index admission was longer for SAVR (10.0 days) than for TAVR (7.0 day) or MT (5.3 days), but the average number of unplanned readmission inpatient days was 2.0 for SAVR, 3.0 for TAVR, and 4.3 for MT; the average number of total admissions was 1.3 for SAVR, 1.5 for TAVR, and 1.7 for MT (P<0.01 for all). TAVR index admission costs decreased over time to become similar to SAVR costs by 2016. CONCLUSIONS: Aggregate costs were higher for TAVR than SAVR and were significantly more expensive than MT alone. However, TAVR costs decreased over time while SAVR and MT costs remained unchanged.