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Objective: Examine the cost-effectiveness of transcatheter aortic valve implantation (TAVI) versus surgical aortic valve replacement (SAVR) for Chinese patients with severe aortic stenosis (AS) at intermediate and high surgical risk., Design: A two-phase model, comprising a 1-month decision tree to simulate perioperative outcomes and a 5-year Markov model with monthly cycles to simulate long-term outcomes, has been developed to evaluate the cost-effectiveness of TAVI compared with SAVR for Chinese patients with AS at intermediate and high risk. The event rates for both phases are sourced from the Placement of Aortic Transcatheter Valves IA and IIA trials, while the cost inputs and utility values are sourced from local sources or published literature. Adjustments for inflation were made using consumer price indexes for healthcare to enhance precision. To ensure the reliability and robustness of the model, sensitivity analyses were conducted to assess their impact on outcomes., Setting: China healthcare system perspective., Participants: A hypothetical cohort of Chinese patients with AS in intermediate and high surgical risk., Interventions: TAVI versus SAVR., Outcome Measures: Cost, quality-adjusted life-years (QALYs), life-years gained and incremental cost-effectiveness Ratio (ICER)., Result: For both intermediate- and high-risk AS patients, offering TAVR resulted in high healthcare costs but moderate benefits compared with SAVR. Specifically, in the intermediate-risk population, TAVR led to a 0.34 QALY increase over SAVR, with an incremental cost of $16 707.58, resulting in an ICER of $49 176.60/QALY. Similarly, in the high-risk population, TAVR showed a 0.15 QALY increase over SAVR, with an incremental cost of $18 093.52, leading to an ICER of $122 696.37/QALY. However, both ICERs exceeded the willingness-to-pay threshold of $37 654.50/QALY. Sensitivity analyses confirmed the model's stability under parameter uncertainty., Conclusion: TAVI was deemed not cost-effective compared with SAVR for patients with AS at intermediate or high surgical risk in the Chinese healthcare system. Lowering valve costs was considered an effective approach to improve the cost-effectiveness of TAVI., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Aims of the Study: The 2021 European Society of Cardiology Guidelines on valvular heart disease recommend transcatheter aortic valve implantation (TAVI) for patients with symptomatic severe aortic stenosis at low surgical risk and age ≥75 years who are suitable for a transfemoral approach (recommendation class IA) based on two large randomised controlled trials (PARTNER 3 and Evolut Low Risk) comparing transcatheter aortic valve implantation with surgical aortic valve replacement (SAVR). Whether such an approach is cost-effective in Switzerland remains unclear. The aim of this cost-utility analysis was to compare transcatheter aortic valve implantation with SAPIEN 3 versus surgical aortic valve replacement in symptomatic severe aortic stenosis patients at low risk of surgical mortality from the perspective of Swiss compulsory health insurance using data from the PARTNER 3 trial (reflecting specifically the safety and efficacy of the SAPIEN 3 TAVI device)., Methods: A previously published two-stage Markov-based model that captured clinical outcomes from the PARTNER 3 trial was adapted from the perspective of the Swiss compulsory health insurance system, using local or geographically close general population mortality and utility data, unit costs and medical resource use from publicly available sources and based on expert opinion. The model had a lifetime horizon with a 3% yearly discounting factor. The cost-utility analysis estimated changes in both direct healthcare costs and health-related quality-adjusted life years for transcatheter aortic valve implantation compared with surgical aortic valve replacement in patients with symptomatic severe aortic stenosis at low risk of surgical mortality., Results: Overall, transcatheter aortic valve implantation with SAPIEN 3 resulted in lifetime costs per patient of CHF 79,534 and quality-adjusted life years per patient of 9.64, compared with surgical aortic valve replacement lifetime costs and quality-adjusted life years per patient of CHF 76,891 and 8.96, respectively. Compared with surgical aortic valve replacement, transcatheter aortic valve implantation was estimated to offer an incremental improvement of +0.68 quality-adjusted life years per patient at an increased cost of +CHF 2643 per patient over a lifetime horizon. The incremental cost-effectiveness ratio was CHF 3866 per quality-adjusted life year gained and remained below CHF 50,000 per quality-adjusted life year gained across several sensitivity analyses., Conclusions: This analysis suggests that transcatheter aortic valve implantation using the SAPIEN 3 device is likely to be a highly cost-effective alternative for symptomatic severe aortic stenosis patients at a low risk of surgical mortality, treated in the contemporary Swiss setting. These findings may help to inform a holistic approach when making policy decisions for the management of this patient group.

Background: Aortic regurgitation is distinguished by the backflow of blood from the aorta into the left ventricle. American College of Cardiology/American Heart Association guidelines recommend surgical aortic valve replacement (SAVR) for patients with symptomatic aortic regurgitation (sAR). This study estimates the difference in mortality, health care use, and costs between patients with sAR who receive SAVR within 12 months of diagnosis versus those who do not., Methods and Results: We used the Optum United Healthcare database to identify 132 317 patients diagnosed with sAR from 2016 to 2021 who had at least 6 months of enrollment before sAR and 12 months of enrollment after. Criteria were no history of aortic stenosis or transcatheter aortic valve replacement and ≥2 visits for heart failure, angina, dyspnea, or syncope. Outcomes were all-cause mortality, health care use, and annualized cost. Baseline differences in demographics and comorbidities were adjusted with inverse propensity score weighting. We modeled survival and estimated health care use and costs using Cox proportional hazards and general linear models, respectively. Of the 132 317 patients, 400 underwent SAVR within 12 months of diagnosis. They were on average younger, more often men, and with a slightly higher Elixhauser Comorbidity Index score. After inverse propensity score weighting, patients with sAR who had SAVR had lower mortality, fewer inpatient and emergency department visits, fewer hospital days, and lower annualized cost., Conclusions: SAVR performed within 12 months of an sAR diagnosis is associated with improved mortality and lower annualized health care use and costs. These clinical and economic benefits should be considered when managing patients with sAR.

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., Competing Interests: Declaration of competing interest Authors report no conflicts of interest., (Copyright © 2024 Elsevier B.V. All rights reserved.)

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., (Published by Elsevier Inc.)

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., (© 2024 The Authors. ESC Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology.)

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., Competing Interests: Declaration of competing interest Dr. Sameer Amin has nothing to disclose. Dr. Suzanne J. Baron serves on the advisory boards of Abiomed, Boston Scientific, Medtronic, and Zoll Medical; receives speaking honoraria from Edwards Lifesciences, Medtronic, and Zoll Medical; and receives research grant support from Abiomed, Acarix. and Boston Scientific. Dr. Benjamin Z. Galper receives research grant support from Edwards Lifesciences., (Copyright © 2024. Published by Elsevier Inc.)

Background: We aimed to examine trends in the utilization and reimbursement of surgical and transcatheter mitral valve therapies and their changing relationship., Methods: A query of administrative data on US Medicare beneficiaries undergoing mitral valve therapy was conducted from 2015 to 2020 using the Centers for Medicare and Medicaid Services Part B National Summary Data File. Inflation adjustment was to the 2020 Consumer Price Index. Trend analysis was quantified with growth rate and simple linear regression calculations., Results: The annual number of all mitral valve procedures remained constant. Transcatheter mitral valve therapies increased by 313% with an increase of 1552 cases per year (P < .001), whereas surgical mitral valve therapies decreased by 31.4% with a decline of 1446 procedures per year (P = .004). As a proportion of all mitral valve therapies, surgical therapies decreased from 91.8% to 65.0%. Annual Medicare reimbursements for transcatheter and surgical mitral valve therapies mirrored the annual procedural trends. For transcatheter mitral valve therapies, per-case reimbursement decreased by 14.1% ($1283.18 to $1102.88), and for surgical mitral valve therapies, per-case reimbursement decreased by 3.8% ($1480.65 to $1424.57)., Conclusions: Medicare utilization of mitral valve therapies has been stable in recent years, with growth of transcatheter volumes offset by a decrease in surgical volumes. This suggests that transcatheter therapy availability has not expanded the pool of patients with access to therapy. Nonetheless, case reimbursements decreased for both modalities., (Copyright © 2024 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

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., Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: IS receives institutional research support from Abbott, Artivion, Atricure, Boston Scientific, Edwards Lifesciences, Medtronic, Terumo Aortic. None related to this manuscript., (Copyright © 2024 Elsevier Inc. All rights reserved.)

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; β -0.98, p<0.001) and reduced costs (β -$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 (β -0.43, p<0.001), but higher overall costs (β $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., Competing Interests: Dr. Peyman Benharash received proctor fees from Atricure as a proctor. This manuscript does not discuss any Atricure products or services. Other authors report no conflicts., (Copyright: © 2024 Le et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

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.

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.

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., (Copyright © 2022 The Authors. Published by Elsevier B.V. All rights reserved.)

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., (Copyright © 2020 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.)

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.

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., (Copyright © 2021 Mayo Foundation for Medical Education and Research. Published by Elsevier Inc. All rights reserved.)

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., Competing Interests: AJS reports grants from NIHR and Wellcome Trust and outside the submitted work. KK reports grants from NIHR outside the submitted work. HPa, HPo and LB are employed by NICE and were contracted by NHS England to oversee the Commissioning through Evaluation scheme. JS is employed by NHS Digital. There are no other financial relationships with any organisations that might have an interest in the submitted work in the previous three years and no other relationships or activities that could appear to have influenced the submitted work. In May 2020 HC moved to a new role and is employed by the Northern Health Science Alliance Ltd., who have no past or present interest in the study. This does not alter our adherence to PLOS ONE policies on sharing data and materials.

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., (Copyright © 2021 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

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.

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., (Copyright © 2020 Elsevier Inc. All rights reserved.)

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., (© 2020 Wiley Periodicals LLC.)

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.

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 CardioMEMS TM 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 CardioMEMS TM system allows the provider to institute timely intensification of HF therapies to alter the course. In trial and registry data, the use of the CardioMEMS TM 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: CardioMEMS TM is relatively safe and cost-effective, reduces heart failure hospitalization rates, and fits into intermediate to high-value medical care.

Objective: In the Levosimendan in Patients with Left Ventricular Systolic Dysfunction Undergoing Cardiac Surgery Requiring Cardiopulmonary Bypass (LEVO-CTS) trial, no differences in clinical outcomes were observed between levosimendan and placebo in a broad population of patients undergoing cardiac surgery. In previous studies, the benefits of levosimendan were most clearly evident in patients undergoing isolated coronary artery bypass grafting (CABG) surgery. In a prespecified analysis of LEVO-CTS, we compared treatment-related outcomes and costs across types of cardiac surgical procedures., Methods: Overall, 563 (66.4%) patients underwent isolated CABG, 97 (11.4%) isolated valve, and 188 (22.2%) combined CABG/valve surgery. Outcomes included the co-primary 4-component composite (30-day mortality, 30-day renal replacement, 5-day myocardial infarction, or 5-day mechanical circulatory support), the 2-component composite (30-day mortality or 5-day mechanical circulatory support), 90-day mortality, low cardiac output syndrome (LCOS), and 30-day medical costs., Results: The 4- and 2-component outcomes were not significantly different with levosimendan and placebo in patients undergoing CABG (15.2% vs 19.3% and 7.8% vs 10.4%), valve (49.0% vs 33.3% and 22.4% vs 2.1%), or combined procedures (39.6% vs 35.9% and 24.0% vs 19.6%). Ninety-day mortality was lower with levosimendan in isolated CABG (2.1% vs 7.9%; hazard ratio [HR], 0.26; 95% confidence interval [CI], 0.11-0.64), but not significantly different in valve (8.3% vs 2.0%; HR, 4.10; 95% CI, 0.46-36.72) or combined procedures (10.4% vs 7.6%; HR, 1.39; 95% CI, 0.53-3.64; interaction P = .011). LCOS (12.0% vs 22.1%; odds ratio, 0.48; 95% CI, 0.30-0.76; interaction P = .118) was significantly lower in levosimendan-treated patients undergoing isolated CABG. Excluding study drug costs, median and mean 30-day costs were $53,707 and $65,852 for levosimendan and $54,636 and $67,122 for placebo, with a 30-day mean difference (levosimendan - placebo) of -$1270 (bootstrap 95% CI, -$8722 to $6165)., Conclusions: Levosimendan was associated with lower 90-day mortality and LCOS in patients undergoing isolated CABG, but not in those undergoing isolated valve or combined CABG/valve procedures., (Copyright © 2019 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: The Cardiothoracic Surgical Trials Network reported that left ventricular reverse remodeling at 2 years did not differ between patients with moderate ischemic mitral regurgitation randomized to coronary artery bypass grafting plus mitral valve repair (n = 150) or coronary artery bypass grafting alone (n = 151). To address health resource use implications, we compared costs and quality-adjusted survival., Methods: We used individual patient data from the Cardiothoracic Surgical Trials Network trial on survival, hospitalizations, quality of life, and US hospitalization costs to estimate cumulative costs and quality-adjusted life years. A microsimulation model was developed to extrapolate to 10 years. Bootstrap and deterministic sensitivity analyses were performed to address uncertainty., Results: In-hospital costs were $59,745 for coronary artery bypass grafting plus mitral valve repair versus $51,326 for coronary artery bypass grafting alone (difference $8419; 95% uncertainty interval, 2259-18,757). Two-year costs were $81,263 versus $67,341 (difference 13,922 [2370 to 28,888]), and quality-adjusted life years were 1.35 versus 1.30 (difference 0.05; -0.04 to 0.14), resulting in an incremental cost-effectiveness ratio of $308,343/quality-adjusted life year for coronary artery bypass grafting plus mitral valve repair. At 10 years, its costs remained higher ($107,733 vs $88,583, difference 19,150 [-3866 to 56,826]) and quality-adjusted life years showed no difference (-0.92 to 0.87), with 5.08 versus 5.08. The likelihood that coronary artery bypass grafting plus mitral valve repair would be considered cost-effective at 10 years based on a cost-effectiveness threshold of $100K/quality-adjusted life year did not exceed 37%. Only when this procedure reduces the death rate by a relative 5% will the incremental cost-effectiveness ratio fall below $100K/quality-adjusted life year., Conclusions: The addition of mitral valve repair to coronary artery bypass grafting for patients with moderate ischemic mitral regurgitation is unlikely to be cost-effective. Only if late mortality benefits can be demonstrated will it meet commonly used cost-effectiveness criteria., (Copyright © 2019 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.)

Objectives: Aortic valve disease is the most frequent indication for heart valve replacement with the highest prevalence in elderly. Tissue-engineered heart valves (TEHV) are foreseen to have important advantages over currently used bioprosthetic heart valve substitutes, most importantly reducing valve degeneration with subsequent reduction of re-intervention. We performed early Health Technology Assessment of hypothetical TEHV in elderly patients (≥ 70 years) requiring surgical (SAVR) or transcatheter aortic valve implantation (TAVI) to assess the potential of TEHV and to inform future development decisions., Methods: Using a patient-level simulation model, the potential cost-effectiveness of TEHV compared with bioprostheses was predicted from a societal perspective. Anticipated, but currently hypothetical improvements in performance of TEHV, divided in durability, thrombogenicity, and infection resistance, were explored in scenario analyses to estimate quality-adjusted life-year (QALY) gain, cost reduction, headroom, and budget impact., Results: Durability of TEHV had the highest impact on QALY gain and costs, followed by infection resistance. Improved TEHV performance (- 50% prosthetic valve-related events) resulted in lifetime QALY gains of 0.131 and 0.043, lifetime cost reductions of €639 and €368, translating to headrooms of €3255 and €2498 per hypothetical TEHV compared to SAVR and TAVI, respectively. National savings in the first decade after implementation varied between €2.8 and €11.2 million (SAVR) and €3.2-€12.8 million (TAVI) for TEHV substitution rates of 25-100%., Conclusions: Despite the relatively short life expectancy of elderly patients undergoing SAVR/TAVI, hypothetical TEHV are predicted to be cost-effective compared to bioprostheses, commercially viable and result in national cost savings when biomedical engineers succeed in realising improved durability and/or infection resistance of TEHV.

Heart valve disease (HVD) affects 2.5% of the US population and one million individuals aged 65 years and older in the UK. Given its burden, the aim of the present review was to assess the cost-effectiveness of heart valve replacement with mechanical versus biological prosthesis in HVD patients. We performed a systematic search in various electronic databases from January 1990 to June 2019. Five out of 542 articles were entered into the study, from which 2 papers were subsequently excluded not meeting the minimum number of items of the CHEERS checklist. Quality-Adjusted Life Year, Life Years Gained, and the Incremental Cost-Effectiveness Ratio (ICER) regarding the type of replaced heart valve were extracted and reported. Studies were conducted in three different countries (Iran, France, and USA). ICER ranged from $1253 in Iran to €54,634 in France. Survival rate of mitral mechanical versus biological valves at 10 and 20 years was 72.9% versus 76.0% and 51% versus 30%, respectively. Survival rate at 20 years in patients undergoing atrial valve replacement was 20%. Ten- and 20-year death rates for biological valves were higher with respect to mechanical prosthesis (15.5% versus 8.4% at 10 years), with this difference becoming more relevant at 20 years (36.9% versus 13.9%). Due to higher ICER, mortality rate, and lower success rates in the long term for biological prostheses compared to mechanical ones, these appear to be more suitable for older patients (aged ≥ 70 years).

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.

Surgical pulmonary valve insertion (SPVI) for re-entry right ventricular outflow tract intervention (RVOTI) remains an established and reproducible approach. Fast-track in patients undergoing RVOTI of the comprehensive valve program targets early ICU and hospital discharge (Hd). Feasibility study for outcome and cost analysis was undertaken. Between January 2015 and December 2016, 34 patients underwent re-entry RVOTI. Seventeen had SPVI and 17 transcatheter PVI (TPVI). Surgical perioperative fast-track protocol was used. Echocardiographic evaluation preoperatively (TTE-1), after RVOTI (TTE-2), at hospital discharge (TTE-3), and follow-up (TTE-4) were obtained. Cost Analysis included procedural and hospital costs. Mean follow-up period was 11.3 ± 6.9 months. All patients were extubated prior to ICU arrival. Mean age was 8.5 ± 7.8 for SPVI [vs 28.5 ± 8.6 years for TPVI] (p < 0.05). There was no hospital mortality or 30-day readmission for SPVI (versus 1 for TPVI).Mean hospital length of stay (LOS) was 4.1 ± 1.1 days for SPVI [vs 1.1 ± 0.7 days for TPVI] (p < 0.05). Number of prior sternal re-entry had no influence on outcome. RV systolic pressure referenced to LVSP (rRVSP, %) and diastolic dimension (RVEDDi, z score) showed sustainable improvement (TTE-2, TTE-3, TTE-4) in both groups compared to TTE-1 (p < 0.05). Mean total hospital cost was $5475.86 ± 2503.91 lower after SPVI (p = 0.09), 21.7% procedural cost reduction. Patients undergoing RVOTI can be safely stratified, based on a customized concept, towards SPVI or TPVI. Standardized strategy can advocate a fast-track path. SPVI is associated with comparable mid-term outcomes to TPVI although SPVI is delivered in younger patients. Despite longer LOS SPVI is associated with reduced hospital cost. Multisite studies might help determine suitability for each strategy on cost containment/quality of life basis.

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., (© 2019 Wiley Periodicals, Inc.)

Objectives: The aim of this study was to assess the real-world impact of transcatheter mitral valve repair (TMVR) on hospitalizations and Medicare costs pre- versus post-TMVR., Background: TMVR is effective in degenerative mitral regurgitation (MR) and appropriately selected patients with functional MR with high surgical risk., Methods: Patients undergoing TMVR in the Society of Thoracic Surgeons/American College of Cardiology TVT (Transcatheter Valve Therapy) Registry from 2013 to 2018 were linked to Medicare claims data. Rates of hospitalizations, hospitalized days, and Medicare costs were compared 1-year pre-TMVR to 1-year post-TMVR., Results: Across 246 sites, 4,970 patients with a median age of 83 years (interquartile range: 77 to 87 years) were analyzed. The TMVR indication was degenerative MR in 77.5% and functional MR in 16.7%. From pre- to post-TMVR, heart failure (HF) hospitalization rates (479 vs. 370 hospitalizations/1,000 person-years; rate ratio [RR]: 0.77) and cardiovascular hospitalizations (838 vs. 632; RR: 0.75) decreased significantly (p < 0.001 for all). Similarly, the rates of hospitalized days decreased for HF and cardiovascular causes (p < 0.05 for all). Following TMVR, the odds of having no Medicare costs for HF hospitalizations increased (69% vs. 79%; odds ratio: 1.67; p < 0.001). However, the average total Medicare costs per day alive among patients with any HF hospitalizations after TMVR increased significantly (p < 0.001). The HF hospitalization rates decreased for patients with functional MR (683 vs. 502; RR: 0.74) and those with degenerative MR (431 vs. 337; RR: 0.78) (p < 0.001)., Conclusions: TMVR is associated with a decrease in cardiovascular and HF hospitalizations and a greater likelihood of having no HF Medicare costs in the year after TMVR, regardless of MR etiology. Further work is necessary to elucidate the reasons for increased costs among patients with HF hospitalizations post-TMVR., (Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Aims: Transcatheter aortic valve implantation (TAVI) is the preferred treatment modality for patients with severe aortic stenosis at high or prohibitive risk for surgical aortic valve replacement (SAVR). We aimed to evaluate real-world outcomes after treatment according to the decisions of the multidisciplinary heart team in a Belgian health-economic context. Methods and results: Four hundred and five high-risk patients referred to a tertiary centre between 1 March 2008 and 31 December 2015 were screened and planned to undergo SAVR, TAVI or medical treatment (MT). Patients undergoing SAVR had lower Society of Thoracic Surgeons scores and Euroscore-II when compared to TAVI or MT (median [IQR]: 6[4-8]; 7[5-10]; 8[6-13]; p  < .001 and 6[4-10]; 8[5-15]; 8[4-16]; p  = .006). At 1 year all-cause mortality was 14, 17 and 51% with SAVR, TAVI and MT, respectively ( p  < .001). Cardiovascular death and disabling stroke occurred in 9, 7 and 35% ( p  < .001) and 2, 2.7 and 1.7% ( p  = .91). According to Valve-Academic-Research-Consortium-II criteria, device success was 95 and 92% for TAVI and SAVR. The combined safety endpoint at 30 days favoured TAVI (22% vs. 47%) ( p  < .001). The combined efficacy endpoint at 1 year was comparable between groups (38 and 40%; p  = .703). Finally, hospital stay was shorter with TAVI vs. SAVR (9[6-14] and 16[12-22] days; p  < .001). Conclusions: Limited resources for transcatheter valve therapies in Belgium push a significant number of patients to SAVR, while TAVI in even higher risk patients translates into similar outcomes and shorter hospital stay. These findings underscore the need for broadening indications for TAVI, as well as readjustment of the budgetary allocations for hospitals in Belgium.

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.

Background: Mitral regurgitation is the second most frequent valvulopathy managed by surgery in Europe. For patients who have a contraindication to surgery or a high surgical risk, the percutaneous MitraClip® implantation procedure has emerged as a favourable alternative approach, but elevated procedural costs are a medicoeconomic concern., Aim: The objective of this study was to evaluate whether the MitraClip® procedure is profitable in a high-volume French hospital., Methods: Patients eligible for mitral valve repair with a MitraClip® device, and covered by the French National Health Service, were included retrospectively in this single-centre study between September 2016 and June 2018. Subgroups were considered based on medicoeconomic severity level. The study primary endpoint was the difference between hospital costs and revenues, calculated for each patient. Secondary endpoints included profit based on severity level, breakdown of costs and adverse events during hospitalization., Results: Twenty-two patients were included in the study. The mean hospital cost and revenue were €30,039±2476 and €30,331±2720 per patient, respectively, resulting in a profit of €292±2039 per patient. The total estimated profit was €6429 for the whole study period. The largest benefits were observed for patients assigned to the higher medicoeconomic severity levels (levels 2 and 3). Profit increased following a reduction in the device cost (€1136±2415 per patient). The price of the device represented 78% of the total costs., Conclusions: Percutaneous MitraClip implantation is a financially neutral procedure for a French university hospital, but this depends on patient severity level., (Copyright © 2019 Elsevier Masson SAS. All rights reserved.)

Background: The recent PARTNER S3i trial compared transcatheter aortic valve implantation (TAVI) using the third-generation SAPIEN 3 device to surgical aortic valve replacement (SAVR) in intermediate-risk patients with severe symptomatic aortic stenosis. Using data from PARTNER S3i, we performed a contemporary cost-effectiveness analysis of current-generation TAVI versus SAVR from the Australian healthcare system perspective., Methods: A Markov model with monthly cycles and a ten-year horizon was constructed to estimate costs, life-years and quality adjusted life-years (QALYs) associated with TAVI and SAVR. Efficacy inputs were derived from the PARTNER S3i study. Costs were estimated from published sources. Deterministic and probabilistic sensitivity analyses were performed to assess model uncertainty., Results: TAVI was found to have higher immediate procedural costs than SAVR, driven primarily by the cost of the transcatheter valve. This was offset by a shorter length of hospitalisation following TAVI, such that the combined cost of initial procedure and hospitalisation was lower in TAVI compared to SAVR. With 5% annual discounting, total costs over ten-years were $50,515 AUD in TAVI and $60,144 AUD in SAVR, and TAVI was found to produce 0.33 more life years and 0.31 more QALYs than SAVR. Thus, from a health economic perspective, TAVI was dominant compared to SAVR. Results were robust to sensitivity analyses, with TAVI being dominant in 68% of 10,000 Monte Carlo iterations and cost-effective in 92% of iterations at a willingness-to-pay threshold of $50,000/QALY gained., Conclusions: TAVI is likely to be highly cost-effective compared to SAVR in intermediate-risk patients with severe aortic stenosis., (Copyright © 2019 Elsevier B.V. All rights reserved.)

Background/purpose: Percutaneous pulmonic valve implantation (PPVI) is an alternative treatment strategy to surgical pulmonic valve implantation (SPVI) for right ventricular outflow tract (RVOT) dysfunction. This study sought to compare outcomes of both treatment strategies., Methods: The study population was extracted from the 2014 Nationwide Readmissions Database (NRD) using International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) codes for PPVI and SPVI. Study outcomes included all-cause in-hospital mortality, length of index hospital stay (LOS), post-procedural bleeding, mechanical complications of heart valve prosthesis, vascular complications (VC), infective endocarditis (IE), total hospitalization charges, and 30-day readmission rates., Results: A total of 975 patient discharges (176 in PPVI and 799 in SPVI group) were identified (average age 25.7 years; 57.5% male). PPVI was associated with significantly shorter median LOS (1 versus 5 days, p < 0.01), lower risk of bleeding (4.6% versus 26.4%, p < 0.01), and lower total hospitalization charges ($169,551.7 versus $210,681.8, p = 0.02). There was no significant difference between both groups in terms of all-cause in-hospital mortality (0% versus 1.4%, p = 0.12), mechanical complications of heart valve prosthesis (1.7% versus 2.0%, p = 0.78), VC (2.3% versus 2.0%, p = 0.82), IE (1.7% versus 3.1%, p = 0.31), or 30-day readmission rates (4.4% versus 7.6%, p = 0.16)., Conclusion: Compared with SPVI, PPVI was associated with shorter LOS, lower bleeding, and lower total charges. There was no significant difference between the two strategies in terms of all-cause in-hospital mortality, mechanical complications of heart valve prosthesis, VC, IE, or 30-day readmission rates., (Copyright © 2018 Elsevier Inc. All rights reserved.)

Background: Contemporary data on mitral valve (MV) surgery in patients with infective endocarditis (IE) are limited., Methods: The National Inpatient Sample was queried to identify patients with IE who underwent MV surgery between 2003 and 2016. We assessed (a) temporal trends in the incidence of MV surgery for IE, (b) morbidity, mortality, and cost of MV repair vs replacement, and (c) predictors of in-hospital mortality., Results: The proportion of MV operations involving patients with IE increased from 5.4% in 2003 to 7.3%, and the proportion of MV repair among those undergoing surgery for IE increased from 15.2% to 25.0% (P trend  < .001). In-hospital mortality was higher in the replacement group (11.3% vs 8.1%; P < .001), and this excess mortality persisted after propensity score matching (11.2% vs 8.1%; P < .001), and in sensitivity analyses excluding concomitant surgery (unadjusted 11.3% vs 4.8%; adjusted 8.5% vs 4.5%; P < .001), and stratifying patients by the time of operation (within 7 days, 11.3% vs 6.8%; P < .001 and >7 days, 11.9% vs 9.1%; P = .012). In the propensity-matched cohorts, shock and need for tracheostomy were more frequent in the replacement group, but rates of stroke, pacemaker implantation, new dialysis, and blood transfusion were similar. Mitral valve repair was, however, associated with shorter hospitalizations, more home discharges, and less cost. In a multivariate regression analysis, age above 70 and chronic dialysis were the strongest predictors of in-hospital mortality., Conclusion: Mitral valve repair in IE patients is associated with lower in-hospital mortality, resource utilization, and cost compared with MV replacement., (© 2019 Wiley Periodicals, Inc.)

Aortic stenosis (AS) is the most common valvular heart disease, with a dismal prognosis when untreated. Recommended therapy is surgical (SAVR) or transcatheter (TAVR) aortic valve replacement. Based on a retrospective cohort of isolated SAVR and TAVR procedures performed in Germany in 2015 (N = 17,826), we examine the impact of treatment selection on in-hospital mortality and total in-hospital costs for a variety of at-risk populations. Since patients were not randomized to the two treatment options, the two endpoints in-hospital mortality and reimbursement are analyzed using logistic and linear regression models with 20 predefined patient characteristics as potential confounders. Incremental cost-effectiveness ratios were calculated as a ratio of the risk-adjusted reimbursement and mortality differences with 95% confidence intervals obtained by Fieller's theorem. Our study shows that TF-TAVR is more costly that SAVR and that cost differences between the procedures vary little between patient groups. Results regarding in-hospital mortality are mixed. SAVR is the predominant procedure among younger patients. For patients older than 85 years or at intermediate and higher pre-operative risk TF-TAVR seems to be the treatment of choice. Incremental cost-effectiveness ratios (ICER) are most favorable for patients older than 85 years (ICER €154,839, 95% CI €89,163-€302,862), followed by patients at higher pre-operative risk (ICER €413,745, 95% CI €258,027-€952,273). A hypothetical shift from SAVR towards TF-TAVR among patients at intermediate pre-operative risk is associated with a less favorable ICER (€1,486,118, 95% CI €764,732-€23,692,323), as the risk-adjusted mortality benefit is relatively small (- 0.97% point), while the additional reimbursement is still eminent (+€14,464). From a German healthcare system payer's perspective, the additional costs per life saved due to TAVR are most favorable for patients older than 85 and/or at higher pre-operative risk.

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., (© 2018 Wiley Periodicals, Inc.)

Background: Coronary ischemia requiring early percutaneous coronary intervention (PCI) is a rare but serious complication of isolated valve surgery. We sought of assess the incidence, predictors and outcomes of early PCI after isolated valve surgery using the national inpatient sample., Methods: Patients who underwent isolated aortic valve replacement (AVR), isolated mitral valve repair (MVr) or replacement (MVR) between 2003 and 2014 were identified. Patients who had early postoperative PCI were compared with patients who did not require PCI. Primary end point was in-hospital mortality. Secondary endpoints were complications, length-of-stay and cost., Results: Among the 135,611 included patients, 1,074 (0.8%) underwent PCI prior to discharge. Unadjusted in-hospital mortality was higher in patients requiring early PCI following AVR (11.2 vs. 3.1%), MVR (24.1 vs. 5.5%), and MVr (22.4 vs. 2.5%) (P < 0.001) compared with patients not requiring PCI. Postoperative PCI remained independently associated with higher mortality after adjusting for demographics, comorbidities and hospital characteristics (adjusted OR [aOR] = 3.74, 95%CI 2.70-5.17 for AVR, aOR = 6.10, 95%CI 4.53-8.23 for MVR, and aOR = 9.90, 95%CI 7.22-13.58 for MVr). Patients undergoing PCI had higher incidences of stroke, acute kidney injury, infectious complications, higher hospital charges, and longer hospitalizations. Age, robotic-assisted surgery, and chronic renal failure were independent predictors of needing early postoperative PCI., Conclusions: Early PCI after isolated aortic or mitral valve surgery is rare but is associated with substantial in-hospital morbidity, mortality, and cost. Further studies are needed to identify preventable causes, and optimal management strategies of this serious complication., (© 2018 Wiley Periodicals, Inc.)

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.

Background: Drug use-associated infective endocarditis (DUA-IE) is increasing as a result of the opioid epidemic. Infective endocarditis may require valve surgery, but surgical treatment of DUA-IE has invoked controversy, and the extent of its use is unknown., Objective: To examine hospitalization trends for DUA-IE, the proportion of hospitalizations with surgery, patient characteristics, length of stay, and charges., Design: 10-year analysis of a statewide hospital discharge database., Setting: North Carolina hospitals, 2007 to 2017., Patients: All patients aged 18 years or older hospitalized for IE., Measurements: Annual trends in all IE admissions and in IE hospitalizations with valve surgery, stratified by patients' drug use status. Characteristics of DUA-IE surgical hospitalizations, including patient demographic characteristics, length of stay, disposition, and charges., Results: Of 22 825 IE hospitalizations, 2602 (11%) were for DUA-IE. Valve surgery was performed in 1655 IE hospitalizations (7%), including 285 (17%) for DUA-IE. Annual DUA-IE hospitalizations increased from 0.92 to 10.95 and DUA-IE hospitalizations with surgery from 0.10 to 1.38 per 100 000 persons. In the final year, 42% of IE valve surgeries were performed in patients with DUA-IE. Compared with other surgical patients with IE, those with DUA-IE were younger (median age, 33 vs. 56 years), were more commonly female (47% vs. 33%) and white (89% vs. 63%), and were primarily insured by Medicaid (38%) or uninsured (35%). Hospital stays for DUA-IE were longer (median, 27 vs. 17 days), with higher median charges ($250 994 vs. $198 764). Charges for 282 DUA-IE hospitalizations exceeded $78 million., Limitation: Reliance on administrative data and billing codes., Conclusion: DUA-IE hospitalizations and valve surgeries increased more than 12-fold, and nearly half of all IE valve surgeries were performed in patients with DUA-IE. The swell of patients with DUA-IE is reshaping the scope, type, and financing of health care resources needed to effectively treat IE., Primary Funding Source: National Institutes of Health.

Background: Aortic valve replacement (AVR) by sutureless prostheses is changing surgeon options, although which patients benefit most, as well as their possible economic impact is still to be defined., Methods: Perceval-S prosthesis (LivaNova) is reserved, at the documented Institution, for patients at perceived high surgical risk. This retrospective analysis of outcome and resource consumption compared Perceval with other tissue valves. To clarify the comparison, only patients respecting 'instructions-for- use' of Perceval were reviewed., Inclusion Criteria: > 65 years, +/- coronary artery bypass grafting, patent foramen ovale closure or myectomy., Exclusion Criteria: bicuspid, combined valve or aortic sur- gery. Costs were calculated per patient on a daily basis including preoperative tests, operating costs (hourly basis), disposables, drugs, blood components and personnel., Results: The sutureless group (SU-AVR) had a higher risk profile than the sutured group (ST-AVR). Cardiopulmonary bypass (CPB) and cross-clamp times were significantly shorter in SU-AVR (isolated AVR: cross-clamp 52.9 ± 12.6 vs. 69 ± 15.3 min, p < 0.001; CPB 79.4 ± 20.3 vs. 92.7 ± 18.2 min, p < 0.001). Hospital mortality was 0.9% in SU-AVR and nil in ST-AVR, p = 0.489; intubation 7 (IQR 5-10.7) and 7 h (IQR 5-9), p = 0.785; intensive care unit 1 (IQR 1-1) and 1 day (IQR 1-1), p = 0.258; ward stay 5.5 (IQR 4-7) and 5 days (IQR 4-6), p = 0.002; pacemaker 5.7% (6/106) and 0.9% (1/109), p = 0.063, respectively. Hospital costs (excluding the prosthesis) were $12,825 (IQR 11,733-15,334) for SU-AVR and $12,386 (IQR 11,217-14,230) in ST-AVR, p = 0.055., Conclusions: Despite higher operative risks in SU-AVR, hospital mortality, morbidity and resource consumption did not differ. Operative times were shorter with the sutureless device and this improve- ment, along with more frequent ministernotomy, may have improved many postoperative aims.

Background: Transcatheter aortic valve replacement (TAVR) has increased in volume as an alternative to surgical aortic valve replacement (SAVR). Comparisons of total episode expenditures, although largely ignored thus far, will be key to the value proposition for payers., Methods: We evaluated 6,359 Blue Cross Blue Shield of Michigan and Medicare fee-for-service beneficiaries undergoing TAVR (17 hospitals, n = 1,655) or SAVR (33 hospitals, n = 4,704) in Michigan between 2012 and 2016. Payments through 90 post-discharge days between TAVR and SAVR were price-standardized and risk-adjusted. Centers were divided into terciles of procedural volume separately for TAVR and SAVR, and payments were compared between lowest and highest terciles., Results: Payments (± SD) were higher for TAVR than SAVR ($69,388 ± $22,259 versus $66,683 ± $27,377, p < 0.001), while mean hospital length of stay was shorter for TAVR (6.2 ± 5.6 versus 10.2 + 7.5 days, p < 0.001). Index hospitalization payments were $4,374 higher for TAVR (p < 0.001), whereas readmission and post-acute care payments were $1,150 (p = 0.001) and $739 (p = 0.004) lower, respectively, and professional payments were similar. For SAVR, high-volume centers had lower episode payments (difference: 5.0%, $3,255; p = 0.01) and shorter length of stay (10.0 ± 7.5 versus 11.1 ± 7.9 days, p = 0.002) than low volume centers. In contrast, we found no volume-payment relationship among TAVR centers., Conclusions: Episode payments were higher for TAVR, despite shorter length of stay. Although not a driver for TAVR, center SAVR volume was inversely associated with payments. These data will be increasingly important to address value-based reimbursement in valve replacement surgery., (Copyright © 2018 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Objective: Aortic valve replacement (AVR) can be performed either through full median sternotomy (FS) or upper mini-sternotomy (MS). The Mini-Stern trial aimed to establish whether MS leads to quicker postoperative recovery and shorter hospital stay after first-time isolated AVR., Methods: This pragmatic, open-label, parallel randomized controlled trial (RCT) compared MS with FS for first-time isolated AVR in 2 United Kingdom National Health Service hospitals. Primary endpoints were duration of postoperative hospital stay and the time to fitness for discharge from hospital after AVR, analyzed in the intent-to-treat population., Results: In this RCT, 222 patients were recruited and randomized (n = 118 in the MS group; n = 104 in the FS group). Compared with the FS group, the MS group had a longer hospital length of stay (mean, 9.5 days vs 8.6 days) and took longer to achieve fitness for discharge home (mean, 8.5 days vs 7.5 days). Adjusting for valve type, sex, and surgeon, hazard ratios (HRs) from Cox models did not show a statistically significant effect of MS (relative to FS) on either hospital stay (HR, 0.874; 95% confidence interval [CI], 0.668-1.143; P = .3246) or time to fitness for discharge (HR, 0.907; 95% CI, 0.688-1.197; P value = .4914). During a mean follow-up of 760 days (745 days for the MS group and 777 days for the FS group), 12 patients (10%) in the MS group and 7 patients (7%) in the FS group died (HR, 1.871; 95% CI, 0.723-4.844; P = .1966). Average extra cost for MS was £1714 during the first 12 months after AVR., Conclusions: Compared with FS for AVR, MS did not result in shorter hospital stay, faster recovery, or improved survival and was not cost-effective. The MS approach is not superior to FS for performing AVR., (Copyright © 2018 The American Association for Thoracic Surgery. All rights reserved.)

Introduction: Cardiac rehabilitation (CR) is recommended for all cardiac patients including patients after cardiac surgery. Since the effect of CR after cardiac surgery has not been well established yet, we conducted a systematic review on the effects of CR for patients after cardiac surgery compared to treatment as usual., Evidence Acquisition: A systematic review of randomized clinical trials (RCTs), quasi-randomized and prospective observational studies in The Cochrane Library, PubMed/MEDLINE and EMBASE was undertaken until October 18th, 2017. Adults after any kind of cardiac surgery were included. Primary outcome was all-cause mortality, other outcomes were serious adverse events, health-related quality of life, work participation, functioning and costs/cost-effectiveness. Risk of bias was evaluated, and the quality of evidence was assessed by the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) criteria., Evidence Synthesis: Eighteen RCTs and 15 observational studies were included. Low risk of bias was only observed in one observational study. Meta-analysis of RCTs suggested no significant difference of CR compared to control on mortality (random-effects relative risk (RR) 0.93 (95% CI: 0.40-1.81), while observational studies suggested statistically significant beneficial effect associated with CR (random-effects RR=0.49, 95% CI: 0.35 - 0.68). CR did not significantly affect any of the other outcomes. Due to the limited data TSA could not be performed., Conclusions: The body of evidence does not allow us to reach any reliable conclusions about the effectiveness of CR following cardiac surgery. Future trials need to be conducted with low risks of bias and clearly defined outcomes.

Background: The CTSN (Cardiothoracic Surgical Trials Network) recently reported no difference in left ventricular end-systolic volume index or in survival at 2 years between patients with severe ischemic mitral regurgitation (MR) randomized to mitral valve repair or replacement. However, replacement provided more durable correction of MR and fewer cardiovascular readmissions. Yet, costeffectiveness outcomes have not been addressed., Methods and Results: We conducted a cost-effectiveness analysis of the surgical treatment of ischemic MR based on the CTSN trial (n=126 for repair; n=125 for replacement). Patient-level data on readmissions, survival, qualityof- life, and US hospital costs were used to estimate costs and quality-adjusted life years per patient over the trial duration and a 10-year time horizon. We performed microsimulation for extrapolation of outcomes beyond the 2 years of trial data. Bootstrap and deterministic sensitivity analyses were done to address parameter uncertainty. In-hospital cost estimates were $78 216 for replacement versus $72 761 for repair (difference: $5455; 95% uncertainty interval [UI]: −7784–21 193) while 2-year costs were $97 427 versus $96 261 (difference: $1166; 95% UI: −16 253–17 172), respectively. Quality-adjusted life years at 2 years were 1.18 for replacement versus 1.23 for repair (difference: −0.05; 95% UI: −0.17 to 0.07). Over 5 and 10 years, the benefits of reduction in cardiovascular readmission rates with replacement increased, and survival minimally improved compared with repair. At 5 years, cumulative costs and quality-adjusted life years showed no difference on average, but by 10 years, there was a small, uncertain benefit for replacement: $118 023 versus $119 837 (difference: −$1814; 95% UI: −27 144 to 22 602) and qualityadjusted life years: 4.06 versus 3.97 (difference: 0.09; 95% UI: −0.87 to 1.08). After 10 years, the incremental cost-effectiveness of replacement continued to improve., Conclusions: Our cost-effectiveness analysis predicts potential savings in cost and gains in quality-adjusted survival at 10 years when mitral valve replacement is compared with repair for severe ischemic MR. These projected benefits, however, were small and subject to variability. Efforts to further delineate predictors of long-term outcomes in patients with severe ischemic MR are needed to optimize surgical decisions for individual patients, which should yield more cost-effective care., Clinical Trial Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT00807040., Competing Interests: Dr Acker: consultant/advisory board for Thoratec (modest). Dr Gillinov: otherresearch support from St. Jude Medical, Abbott (modest); consultant/advisoryboard for St. Jude Medical, Edwards Lifesciences (modest); consultant/advisoryboard for Abbott, Medtronic, CryoLife, AtriCure (significant). Dr Thourani: researchgrants from Edwards Lifesciences, Medtronic Corp, and Abbott Medical(modest); consultant/advisory board for Edwards Lifesciences, Abbott Medical(modest). Dr Robert L. Smith: research grant from Edwards Lifesciences (significant);speakers bureau for Abbott Medical (significant); consultant/advisoryboard for Abbott Medical, Edwards Lifesciences (significant); other from AbbottMedical, Edwards Lifesciences (significant). The other authors report noconflicts. This work was supported by a cooperative agreement (U01 HL088942) fundedby the National Heart, Lung, and Blood Institute and the National Institute ofNeurological Disorders and Stroke of the National Institute of Health and theCanadian Institutes of Health Research. Dr Ferket was supported by AmericanHeart Association grant number 16MCPRP31030016. The views expressed inthis article are those of the authors and do not necessarily represent the viewsof the National Heart, Lung, and Blood Institute; National Institutes of Health;or the United States Department of Health and Human Services., (2018 American Heart Association, Inc.)

Background: Innovative technologies challenge healthcare systems, as evidence on costs and benefits frequently usually are slow to reflect new technology. We investigated these dynamics for Germany, using the emergence of transcatheter aortic valve implementation (TAVI) as an alternative to conventional aortic valve replacements (CAVR)., Objective: We focused on the role of patient co-morbidity-which would be a medical explanation for adopting TAVI-and hospital ownership status, hypothesizing that for-profit facilities are more likely to capitalize on the favorable reimbursement conditions of TAVI., Methods: The analysis uses claims data from the Techniker Krankenkasse, the largest health insurance fund in Germany, for the years 2009-2015, covering 2892 patients with TAVI and 9523 with CAVR. The decision on TAVI versus CAVR was estimated for patient-level data, that is, socioeconomic data as well as co-morbidity. At the hospital level, we included the ownership type. We also controlled for effects of the respective owner (rather than the type of ownership), including a random intercept., Results: While the co-morbidity score of TAVI patients was much higher in the early years, over time, the score almost converged with that of CAVR patients. This is in agreement with emerging evidence that suggests the use of TAVI also leads to better patient outcomes. Our results indicate that the type of ownership does not drive the switch to TAVI. We found little, if any, effect from the respective owner, regardless of ownership type., Conclusion: Overall, the effects of co-morbidity suggest that providers acted responsibly when adopting TAVI while evidence was still emerging.