Structural hemodynamic valve deterioration durability of RESILIA-tissue versus contemporary aortic bioprostheses.

Aim: Durability of aortic valve replacement is becoming increasingly important. Aortic bioprostheses with RESILIA tissue have demonstrated outstanding outcomes thus far, but only in single-arm studies. Methods: We compared structural valve deterioration (SVD)-related hemodynamic valve deterioration (HVD) of grade ≥2 of RESILIA tissue valves from the COMMENCE trial (n = 689) to those from the PARTNER 2A contemporary AVR arm (n = 936) based upon annual core laboratory echocardiograms through 5 years of follow-up. Results: SVD-related HVD in the COMMENCE and PARTNER 2A cohorts were 1.8 versus 3.5%, respectively (one-sided 95% lower-bound hazard ratio of 0.92; p = 0.07). In propensity-matched cohorts (n = 239), these outcomes were 1.0 versus 4.8%, respectively (one-sided 95% lower-bound hazard ratio of 1.15; p = 0.03). Conclusion: RESILIA tissue-based AVR exhibited reduced SVD-related HVD compared with a contemporary AVR cohort devoid of RESILIA tissue.

Long-run savings associated with surgical aortic valve replacement using a RESILIA tissue bioprosthetic valve versus a mechanical valve.

BACKGROUND: Prior economic analyses demonstrate that legacy tissue valves are associated with substantial financial savings over the long run after a surgical aortic valve replacement (SAVR). Bioprostheses with RESILIA tissue reduce calcification, the primary cause of structural valve deterioration (SVD), and have demonstrated promising pre-clinical and 5-year clinical results. This economic evaluation quantifies the expected long-run savings of bioprosthetic valves with RESILIA tissue relative to mechanical valves given 5-year clinical results and expected performance through year 15. METHODS: Simulation models estimated disease progression across two hypothetical SAVR cohorts (tissue vs. mechanical) of 10,000 patients in the US over 15 years. One comparison evaluated RESILIA tissue valves relative to mechanical valves. The other compared legacy SAVR tissue and mechanical valves. Health outcome probabilities and costs were based on literature and expert opinion. Incidence rates of health outcomes associated with mechanical valve were calculated using relative risks of expected outcomes in tissue valve versus mechanical valve patients. The comparisons also accounted for anti-coagulation monitoring in both cohorts. Savings estimates are based on US healthcare costs and do not yet account for the premium associated use of RESILIA relative to a standard tissue valve. RESULTS: Relative to mechanical SAVR, the median net discounted savings for a patient receiving SAVR with a RESILIA tissue valve is $20,744 ($US, 2020; 95% CI = $15,835-$26,655) over a 15-year horizon. While 30-day and 1-year savings were not significant, expected savings after 5 years are $9,110 (95% CI = $6,634-$11,969). Net savings for RESILIA SAVR valves were approximately 30-50% larger than savings anticipated using legacy tissue SAVR valves. CONCLUSION: RESILIA tissue valves are associated with lower health expenditures relative to mechanical valves.

Reimbursement Savings Associated With Tissue Versus Mechanical Surgical Aortic Valve Replacement in Thailand.

OBJECTIVES: Surgical aortic valve replacement (SAVR) is an indicated treatment for severe aortic stenosis. Although mechanical valves are typically more durable, tissue SAVR valves do not require lifetime anticoagulation monitoring and may have lower rates of expensive sequelae. This economic evaluation estimates payer costs to the 3 largest Thai health insurance mechanisms for tissue versus mechanical SAVR. METHODS: A deterministic and Monte Carlo simulation model based on literature and expert opinion estimated total payer costs for tissue and mechanical valves over a 25-year duration for 3 separate age cohorts (45, 55, and 65 years). Reimbursements levels for hospitalization services were from the Thai Diagnosis Related Groups. Separate models are generated for the 3 main Thai health insurance mechanisms. RESULTS: The discounted expected 25-year reduction in payer savings associated with tissue SAVR are $2540, $2529, and $2311 per surgery for patients aged 45, 55, and 65 years, respectively, for the largest Thai insurer. Expected cost reductions associated with tissue SAVR are larger for each of the other schemes and generally decrease with patient age. Most savings accrue within 10 years of surgery. Reoperation costs are larger with tissue valves, but reductions in complications and anticoagulation monitoring more than offset these expenditures. Results are robust to multiple sensitivity and scenario analyses. CONCLUSIONS: Coverage and reimbursement of tissue valves can financially benefit Thai insurers and reduce expenditures in the Thai health system compared with mechanical valves. As tissue valve technology evolves and reoperation rates decline, the financial benefit associated with tissue valves will increase.

Patient preferences for mitral valve regurgitation treatment: a discrete choice experiment.

INTRODUCTION: This study aimed to quantify patients' preferences for benefits and risks associated with treating degenerative mitral regurgitation (DMR) via open heart surgical repair versus a beating heart surgical approach. METHODS: A D-efficient main effects discrete choice experiment (DCE) survey with 10 choice tasks that involved trade-offs across six attributes varying between two and four levels each (procedure invasiveness, recovery intensity, risk of disabling stroke, risk of new onset atrial fibrillation, risk of symptom reappearance and risk of reintervention) was administered online to either clinically confirmed (n = 30) or self-reported DMR (n = 88) patients recruited from either cardiovascular clinics or online clinical patient databases. The error component logit (ECL) analysis combined both patient cohorts after performing a Swait-Louviere scale test. Patient trade-offs across attributes were estimated in relation to either an open-heart surgery (OHS) treatment profile or a beating heart approach. RESULTS: Patients demonstrated clear preferences across all attributes for the beating heart treatment. 76.0% (95% CI: 68.1,83.9) of patients would prefer a 'beating heart' intervention relative to the 'open heart' approach despite the higher likelihood of symptom recurrence and reintervention. In exchange for the combined net benefits associated with a 'beating heart' treatment, on average, participants were willing to accept a maximum acceptable risk (MAR) of 34.6 percentage points (95% CI: 23.8,45.4) for increased risk of symptom reappearance or 22.6 percentage points (95% CI: 14.7,30.4) increased risk of reintervention. CONCLUSION: This study of US adults with DMR provides quantitative measures of risk tolerance for tradeoffs related to repair by a beating heart approach relative to conventional open-heart surgery (standard of care). These results may inform DMR treatment choices from regulatory agencies, payers, clinicians, and patients considering a beating heart repair or treatments with similar attributes as potential new alternatives to conventional surgery.

Long-term Healthcare Expenditures Over Time for Tissue and Mechanical Aortic Valve Replacement.

BACKGROUND: Guidelines currently indicate the use of surgical aortic valve replacement (SAVR) to treat severe cases of aortic stenosis, particularly for low- to medium-risk patients. Although several studies have compared health outcomes of tissue and mechanical SAVR, this economic simulation model estimates the difference in long-term healthcare costs associated with tissue relative to mechanical SAVR. METHODS: The deterministic and Monte Carlo simulation models used literature-based epidemiologic and cost inputs to calculate annual expenditures related to SAVR for up to 25 years after initial surgery. A series of 3 cohort studies across different age groups provided the health outcome probabilities for tissue valve patients. Outcome probabilities for mechanical valve patients were based on relative risks reported in comparative meta-analyses or large cohort studies. RESULTS: Relative to mechanical SAVR the expected net discounted savings for a patient receiving tissue SAVR at ages 45, 55, and 65 years were $12,266, $15,462, and $16,008, respectively (based on 2018 US dollars) over a 25-year horizon (95% confidence intervals exceed $0). For a 45-year-old tissue SAVR patient, the estimated per-patient cost difference (relative to mechanical SAVR) of reoperation over 25 years ($16,201) were offset by expected savings on anticoagulation monitoring ($26,257) over the same period. In a sensitivity analysis in which mortality risk was assumed equal, significant long-term savings associated with tissue SAVR still accrued in each of the 3 age cohorts. CONCLUSIONS: Payers, providers, and the healthcare system may financially benefit from the use of tissue valves because significant savings were associated with the use of tissue valves relative to mechanical valves for SAVR.

Hospital costs associated with intraoperative hypotension among non-cardiac surgical patients in the US: a simulation model.

Objective: Recent studies indicate intraoperative hypotension, common in non-cardiac surgical patients, is associated with myocardial injury, acute kidney injury, and mortality. This study extends on these findings by quantifying the association between intraoperative hypotension and hospital expenditures in the US. Methods: Monte Carlo simulations (10,000 trial per simulation) based on current epidemiological and cost outcomes literature were developed for both acute kidney injury (AKI) and myocardial injury in non-cardiac surgery (MINS). For AKI, three models with different epidemiological assumptions (two models based on observational studies and one model based on a randomized control trial [RCT]) estimate the marginal probability of AKI conditional on intraoperative hypotension status. Similar models are also developed for MINS (except for the RCT case). Marginal probabilities of AKI and MINS sequelae (myocardial infarction, congestive heart failure, stroke, cardiac catheterization, and percutaneous coronary intervention) are multiplied by marginal cost estimates for each outcome to evaluate costs associated with intraoperative hypotension. Results: The unadjusted (adjusted) model found hypotension control lowers the absolute probability of AKI by 2.2% (0.7%). Multiplying these probabilities by the marginal cost of AKI, the unadjusted (adjusted) AKI model estimated a cost reduction of $272 [95% CI = $223-$321] ($86 [95% CI = $47-$127]) per patient. The AKI model based on relative risks from the RCT had a mean cost reduction estimate of $281 (95% CI = -$346-$750). The unadjusted (adjusted) MINS model yielded a cost reduction of $186 [95% CI = $73-$393] ($33 [95% CI = $10-$77]) per patient. Conclusions: The model results suggest improved intraoperative hypotension control in a hospital with an annual volume of 10,000 non-cardiac surgical patients is associated with mean cost reductions ranging from $1.2-$4.6 million per year. Since the magnitude of the RCT mean estimate is similar to the unadjusted observational model, the institutional costs are likely at the upper end of this range.

A Monte Carlo simulation estimating US hospital cost reductions associated with hypotension control in septic ICU patients.

OBJECTIVE: This economic analysis extends upon a recent epidemiological study to estimate the association between hypotension control and hospital costs for septic patients in US intensive care units (ICUs). METHODS: A Monte Carlo simulation decision analytic model was developed that accounted for the probability of complications-acute kidney injury and mortality-in septic ICU patients and the cost of each health outcome from the hospital perspective. Probabilities of complications were calculated based on observational data from 110 US hospitals for septic ICU patients (n = 8,782) with various levels of hypotension exposure as measured by mean arterial pressure (MAP, units: mmHg). Costs for acute kidney injury (AKI) and mortality were derived from published literature. Each simulation calculated mean hospital cost reduction and 95% confidence intervals based on 10,000 trials. RESULTS: In the base-case analysis hospital costs for a hypothetical "control" cohort (MAP of 65 mmHg) were $699 less per hospitalization (95% CI: $342-$1,116) relative to a "case" cohort (MAP of 60 mmHg). In the most extreme case considered (45 mmHg vs 65 mmHg), the associated cost reduction was $4,450 (95% CI: $2,020-$7,581). More than 99% of the simulated trials resulted in cost reductions. A conservative institution-level analysis for a hypothetical hospital (which assumes no benefit for increasing MAP above 65 mmHg) estimated a cost decline of $417 for a 5 mmHg increase in MAP per ICU septic patient. These results are applicable to the US only. CONCLUSIONS: Hypotension control (via MAP increases) for patients with sepsis in the ICU is associated with lower hospitalization cost.