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

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

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

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

Cost-analysis of percutaneous pulmonary valve implantation compared to surgical pulmonary valve replacement.

OBJECTIVES: To perform cost evaluation and economic modeling of percutaneous pulmonary valve implantation (PPVI) compared to surgical revision. BACKGROUND: While, PPVI appears to be a viable alternative to surgical conduit revision in select patients with right ventricular outflow tract anomalies, its overall economic burden has yet to be determined. METHODS AND RESULTS: We examined the first 17 patients who underwent PPVI at our institution and compared them with the most-recently placed surgical valves. Economic data were obtained from the actual procedural and in-hospital charges and used as the base estimates for 5- and 10-year future modeling with appropriate sensitivity analysis. Median total hospital and procedural charges incurred by the patient were significantly higher for the surgical valve compared with PPVI ($126,406 ± $38,772 vs. $80,328 ± $17,387, P < 0.001). Median total societal charges were also higher for the surgical valve ($129,519 ± $39,021 vs. $80,939 ± $17,334, P < 0.001) owing to an average wage loss of $3,113 for surgical patients, contrasted to $611 who underwent PPVI, and a shorter length of stay (1.0 ± 0 vs. 5.7 ± 2.2, P <0.001) for PPVI. Sensitivity analysis determined that PPVI would need to fail at a rate of 17% per year (or 93% at 10 years) to lose its cost advantage. CONCLUSIONS: PPVI holds a significant cost advantage over the surgical approach, fewer hospital days, and incurs less patient wage loss. Furthermore, it would need to have a very high failure rate at 10 years to lose its cost advantage.

Innovative technology-transcatheter aortic valve implantation: cost and reimbursement issues.

OBJECTIVE: Transcatheter aortic valve implantation (TAVI) offers a new treatment option for patients with severe symptomatic aortic valve stenosis, classified as "inoperable". The purpose of the study was to reveal the association between ascertained hospital costs with the actual patient Diagnosis-Related Group (DRG). METHOD: We examined 50 consecutive patients who underwent either transapical TAVI, (TAVI-TA) or transfemoral TAVI (TAVI-TF) with the Edwards SAPIEN valve and CoreValve(®) between September 2009 and August 2011. RESULTS: Fourty-nine patients had successful valve deployment. Seven patients died within 30 days of the operation. The mean length of hospital stay for TAVI-TA was 199 hours (range 77-362), and the mean costs for TAVI-TA were 55,690 US$. For TAVI-TF the mean length of hospital stay was 170 hours (range 49-276) and the mean costs were 52,087 US$. CONCLUSION: There was no significant difference between TAVI-TA and TAVI-TF patient characteristics. There was a significant discrepancy between actual hospital costs and the current Norwegian DRG reimbursement for the TAVI procedure. This discrepancy can be partly explained by excessive costs related to the introduction of a new program with new technology. Costly innovations should be considered in price-setting of reimbursement for novel technology.

Cost-effectiveness of homograft heart valve replacement surgery: an introductory study.

The clinical effectiveness of heart valve replacement surgery has been well documented. Mechanical and homograft valves are used routinely for replacement of damaged heart valves. Homograft valves are produced in our country but we import the mechanical valves. To our knowledge the cost-effectiveness of homograft valve has not been assessed. The objective of the present study was to compare the cost-effectiveness of homograft valve replacement with mechanical valve replacement surgery. Our samples were selected from 200 patients that underwent homograft and mechanical heart valve replacement surgery in Imam-Khomeini hospital (2000-2005). In each group we enrolled 30 patients. Quality of life was measured using the SF-36 questionnaire and utility was measured in quality-adjusted life years (QALYs). For each group we calculated the price of heart valve and hospitalization charges. Finally the cost-effectiveness of each treatment modalities were summarized as costs per QALYs gained. Forty male and twenty female participated in the study. The mean score of quality of life was 66.06 (SD = 9.22) in homograft group and 57.85 (SD = 11.30) in mechanical group (P < 0.05). The mean QALYs gained in homograft group was 0.67 more than mechanical group. The incremental cost-effectiveness ratio (ICER) revealed a cost savings of 1,067 US$ for each QALY gained in homograft group. Despite limitation of this introductory study, we concluded that homograft valve replacement was more effective and less expensive than mechanical valve. These findings can encourage healthcare managers and policy makers to support the production of homograft valves and allocate more recourse for developing such activities.

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

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

Early cost-utility analysis of tissue-engineered heart valves compared to bioprostheses in the aortic position in elderly patients.

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.

Cost-Effectiveness of Transcatheter Aortic Valve Implantation Using a Balloon-Expandable Valve in Japan: Experience From the Japanese Pilot Health Technology Assessment.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) is an innovative and effective treatment in high-surgical-risk (HR) and inoperable patients with symptomatic severe aortic stenosis. OBJECTIVES: This cost-effectiveness analysis of transfemoral TAVI (TF-TAVI) compared with surgical aortic valve replacement (SAVR) conforms with the methodological guidelines for cost-effectiveness evaluation by the Ministry of Health, Labor, and Welfare in Japan. METHODS: The cost-effectiveness of TF-TAVI using SAPIEN XT was evaluated using a lifetime Markov simulation from the national payer perspective. Comparators were SAVR for HR patients and standard of care (SOC) for inoperable patients. A systematic literature review for clinical evidence of TF-TAVI and comparators was conducted. The evidence for TF-TAVI was derived from the SOURCE XT registry and Japanese post marketing surveillance. Because there was no literature directly or indirectly comparing TF-TAVI using SAPIEN XT with comparators, the comparator data were selected from relevant published studies, considering the similarity of study eligibility criteria and patient backgrounds (eg, age and surgical risk scores). Sensitivity analyses were used to validate the robustness of results. RESULTS: The incremental cost-effectiveness ratio of TF-TAVI versus SAVR for HR patients was ¥1.3 million/quality-adjusted life-years (QALYs). The incremental cost-effectiveness ratio of TF-TAVI versus SOC for inoperable patients was ¥3.5 million/QALY. CONCLUSIONS: TF-TAVI was cost-effective when compared with SAVR for HR patients and when compared with SOC for inoperable patients, using a threshold of ¥5 million/QALY.

Costs associated with hospital-acquired bacteraemia in an Indian hospital: a case-control study.

Studies from around the world have shown that hospital-acquired infections increase the costs of medical care, morbidity and mortality. The aim of this study was to determine cost and attributable mortality associated with hospital-acquired bacteraemia in a tertiary care centre in India. This was a retrospective case-control, cost utility analysis set in the cardiothoracic unit of a 200-bedded tertiary care cardiac hospital. Cases included adult patients who underwent coronary artery bypass graft and/or valve replacement surgery who developed bacteraemia (indicated by positive blood cultures) during postoperative stay (N=24). Controls were age- and sex-matched adult patients who underwent similar procedures but who did not develop bacteraemia (N=48). Data were collected from patient medical records and other administrative databases for cost analysis. Prolongation of hospital stay, attributable mortality and extra costs associated with hospital-acquired bacteraemia were analysed. Statistical analysis was done using Fisher's exact test and unpaired t-test. Patients with hospital-acquired bacteraemia experienced a significantly longer total hospital stay [mean: 22.9 days; 95% confidence interval (CI): 17.2-28.6; P<0.0001], significantly longer ICU stay (mean: 11.3 days; 95% CI: 9.0-13.6; P<0.0001), a significantly higher mortality (mean: 54%; P<0.0001) and cost significantly more (mean: US $14,818; 95% CI: 10,663-18,974; P<0.0001) than controls. We conclude that hospital-acquired bacteraemia significantly increases mortality and costs of hospitalisation in lower income developing countries. Our study demonstrates that costs associated with HAIs are similar between developing and developed countries. Better infection control planning and infrastructure may offset some of these costs.

Cost-effectiveness of transcatheter aortic valve implantation compared to surgical aortic valve replacement in the intermediate surgical risk population.

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.

Cost-comparison of third generation transcatheter aortic valve implantation (TAVI) devices in the German Health Care System.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) has a substantial impact on daily cardiovascular care delivery based on issues such as cost effectiveness and economic value within a restricted health care budget. Until now, potential financial benefits of third generation valve models have not been evaluated in a real-world setting. METHODS AND RESULTS: We identified 204 eligible patients (Jan 2014-Sep 2016) who either received the balloon-expandable Edwards Sapien 3 (ES3) or the self-expandable Medtronic Evolut R (MER). Baseline information, procedural characteristics, 30-day outcome as well as in-hospital costs and reimbursement were collected and analyzed. The major cost driver was initial valve-kit costs with a significantly higher amount in the ES3 group, which was set at 0 with the lower price (ES3/MER: +4390.0€â€¯±â€¯3.807.0 vs. 0.0€â€¯±â€¯734.1; p < 0.01). However, initial valve-kit costs were balanced by additional material costs in the MER cohort. Overall costs did not differ significantly between valve models (ES3/MER: x + 13.808.0€â€¯±â€¯5.595.0 vs. x + 10.681.0€â€¯±â€¯4.518.0; p = 0.6885) and reimbursement was moderate (ES3/MER: 1.649.7€ vs. 4776.7€). CONCLUSION: Quality, success rate, and costs were comparable between third generation devices. Initial valve-kit costs were significantly higher in the ES3 group, whereas overall costs did not significantly differ between the two valve types.

Left Ventricular Rapid Pacing Via the Valve Delivery Guidewire in Transcatheter Aortic Valve Replacement.

OBJECTIVES: This study investigated whether left ventricular (LV) stimulation via a guidewire-reduced procedure duration while maintaining efficacy and safety compared with standard right ventricular (RV) stimulation. BACKGROUND: Rapid ventricular pacing is necessary to ensure cardiac standstill during transcatheter aortic valve replacement (TAVR). METHODS: This is a prospective, multicenter, single-blinded, superiority, randomized controlled trial. Patients undergoing transfemoral TAVR with a SAPIEN valve (Edwards Lifesciences, Irvine, California) were allocated to LV or RV stimulation. The primary endpoint was procedure duration. Secondary endpoints included efficacy, safety, and cost at 30 days. RESULTS: Between May 2017 and May 2018, 307 patients were randomized, but 4 were excluded because they did not receive the intended treatment: 303 patients were analyzed in the LV (n = 151) or RV (n = 152) stimulation groups. Mean procedure duration was significantly shorter in the LV stimulation group (48.4 ± 16.9 min vs. 55.6 ± 26.9 min; p = 0.0013), with a difference of -0.12 (95% confidence interval: -0.20 to -0.05) in the log-transformed procedure duration (p = 0.0012). Effective stimulation was similar in the LV and RV stimulation groups: 124 (84.9%) versus 128 (87.1%) (p = 0.60). Safety of stimulation was also similar in the LV and RV stimulation groups: procedural success occurred in 151 (100%) versus 151 (99.3%) patients (p = 0.99); 30-day MACE-TAVR (major adverse cardiovascular event-transcatheter aortic valve replacement) occurred in 21 (13.9%) versus 26 (17.1%) patients (p = 0.44); fluoroscopy time (min) was lower in the LV stimulation group (13.48 ± 5.98 vs. 14.60 ± 5.59; p = 0.02), as was cost (€18,807 ± 1,318 vs. €19,437 ± 2,318; p = 0.001). CONCLUSIONS: Compared with RV stimulation, LV stimulation during TAVR was associated with significantly reduced procedure duration, fluoroscopy time, and cost, with similar efficacy and safety. (Direct Left Ventricular Rapid Pacing Via the Valve Delivery Guide-wire in TAVR [EASY TAVI]; NCT02781896).

Is the MitraClip® procedure profitable in a high-volume French hospital?

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.

Cost-Effectiveness of Self-Expandable Transcatheter Aortic Valves in Intermediate-Risk Patients.

BACKGROUND: A recent clinical trial showed that self-expandable transcatheter aortic valve replacement (TAVR) was non-inferior to surgical aortic valve replacement (SAVR). However, the cost-effectiveness of self-expandable TAVR in the intermediate-risk population remains unknown. METHODS: A cost-utility analysis from the Canadian health care system payer's perspective was undertaken to compare self-expandable TAVR with SAVR. A fully probabilistic Markov model over the patient's lifetime was constructed to estimate differences in costs (2016 Canadian dollars) and effectiveness (quality-adjusted life-years [QALYs]), discounted at 1.5% per annum. Incremental cost-effectiveness ratios (ICERs) were calculated. Efficacy inputs were obtained from the Surgical Replacement and Transcatheter Aortic Valve Implantation trial, and costs were primarily obtained from the Canadian Institute of Health Information. Probabilistic analysis (PA) and one-way deterministic sensitivity analyses were conducted around key point estimates to address uncertainty. RESULTS: In the base case analysis, with discounting, the total lifetime costs (mean ± standard deviation) in the TAVR and SAVR arms were $44,299 ± $7,260 and $32,994 ± $13,434, respectively, whereas total effectiveness values were 6.42 ± 1.33 QALYs and 6.28 ± 1.32 QALYs, respectively. This yielded an incremental cost of $11,305 and incremental effectiveness of 0.15 QALYs when TAVR was compared with SAVR for an ICER of $76,736/QALY. In the PA, there was moderate uncertainty, with 52.8% and 57.2% of simulations less than willingness-to-pay thresholds of $50,000 and $100,000, respectively. In the sensitivity analysis, when the cost of TAVR valve system was priced at $17,397 (base case $22,000 Canadian dollars), TAVR was found to be cost-effective at a willingness-to-pay threshold of $50,000/QALY. CONCLUSIONS: Self-expandable TAVR was found to be cost-effective; however, there was moderate uncertainty, reflecting the non-inferiority nature of the data.

Is transcatheter aortic valve replacement a profitable procedure in a high-volume French hospital?

BACKGROUND: Transcatheter aortic valve replacement (TAVR) has revolutionized the prognosis of inoperable patients with severe aortic valve stenosis. Yet, the implantation of expensive prostheses in patients with comorbidities may be questionable in an era when healthcare costs are becoming a major concern. AIM: The objective of this study was to assess whether the TAVR procedure is profitable in a high-volume French hospital. METHODS: Consecutive patients eligible for transfemoral TAVR using the SAPIEN bioprostheses (Edwards Lifesciences, Irvine, CA, USA) were included retrospectively in this single-centre study between September 2014 and December 2015. Three medicoeconomic severity-level subgroups were considered. The primary clinical endpoint was the difference between hospital costs and revenues, calculated for each patient. Secondary composite endpoints included major adverse events within 30 days and breakdown of costs. RESULTS: Overall, 189 patients were included in the analysis. Three patients died (two from non-cardiac causes) within 30 days of the procedure. The mean hospital cost was €27,530±3814 per patient, and the mean hospital income was €30,313±2681 per patient (P<0.001), resulting in a significant profit of €2783±1743 per patient. The total estimated profit was €525,000 for the whole study period. The largest benefits were observed for patients assigned to the lowest severity level. The price of the bioprosthesis represented 71% of the total costs. CONCLUSIONS: The TAVR procedure performed in carefully selected patients was profitable for the academic centre, regardless of the level of severity assigned to the patients.

Pathophysiology, incidence and predictors of conduction disturbances during Transcatheter Aortic Valve Implantation.

INTRODUCTION: Over the past decade, transcatheter aortic valve implantation (TAVI) has evolved rapidly toward an extremely reproducible, safe and effective procedure, with a marked reduction of its related complications. However, the occurrence of conduction disturbances and the need for permanent pacemaker implantation (PPI) after TAVI remains a concern. Areas covered: In this article review, we will go through the mechanisms involved in conduction disturbances after TAVI, and we will discuss the key aspects of pathophysiology, incidence and predictors of conduction disturbances following Transcatheter Aortic Valve Implantation. The evaluation of patient's valve anatomy and the selection of the most appropriate prosthesis have been proposed as a valuable options to reduce the incidence of conductions disturbances. Moreover, in recent times, a great number of new TAVI devices, so-called 'second-generation devices', have been introduced to address the limitations of the first-generation devices, including conduction disturbance, with scarce results. Expert commentary: Conduction disturbances after TAVI are increasingly recognized as an important issue in TAVI complications. Further characterization of the procedural- and patient-related factors that contribute to the development of conduction abnormalities will help to improve prosthesis designs and patient selection, making TAVI even more safer.

Cost and contribution margin of transcatheter versus surgical aortic valve replacement.

OBJECTIVE: To compare the cost of and payments for transcatheter aortic valve replacement (TAVR), a novel and expensive technology, and surgical aortic valve replacement (SAVR). METHODS: Medicare claims provided hospital charges, payments, and outcomes between January and December 2012. Hospital costs and charges were estimated using hospital-specific cost-to-charge ratios. Costs and payments were examined in propensity score- matched TAVR and SAVR patients. RESULTS: Medicare spent $215,770,200 nationally on 4083 patients who underwent TAVR in 2012. Hospital costs were higher for TAVR patients (median, $50,200; interquartile range [IQR], $39,800-$64,300) than for propensity-matched SAVR patients ($45,500; IQR, $34,500-$63,300; P < .01), owing largely to higher estimated medical supply costs, including the implanted valve prosthesis. Postprocedure hospital length of stay (LOS) length was shorter for TAVR patients (median, 5 days [IQR, 4-8 days] vs 7 days [IQR, 5-9 days]; P < .01), as was total intensive care unit (ICU) LOS (median, 2 days [IQR, 0-5 days] vs 3 days [IQR, 1-6 days]; P < .01). Medicare payments were lower for TAVR hospitalizations (median, $49,500; IQR, $36,900-$64,600) than for SAVR (median, $50,400; IQR, $37,400-$65,800; P < .01). The median of the differences between payments and costs (contribution margin) was -$3380 for TAVR hospitalizations and $2390 for SAVR hospitalizations (P < .01). CONCLUSIONS: TAVR accounted for $215 million in Medicare payments in its first year of clinical use. Among SAVR Medicare patients at a similar risk level, TAVR was associated with higher hospital costs despite shorter ICU LOS and hospital LOS. Overall and/or medical device cost reductions are needed for TAVR to have a net neutral financial impact on hospitals.

The economic value of rapid deployment aortic valve replacement via full sternotomy.

AIM: To compare the economic value of EDWARDS INTUITY Elite™ (EIE) valve system for rapid-deployment aortic valve replacement (RDAVR) in a full sternotomy (FS) approach (EIE-FS-RDAVR) versus FS-AVR using conventional stented bioprosthesis. DATA & METHODS: A simulation model to compare each treatment's 30-day inpatient utilization and complication rates utilized: clinical end points obtained from the TRANSFORM trial patient subset (EIE-FS-RDAVR) and a best evidence review of the published literature (FS-AVR); and costs from the Premier database and published literature. RESULTS: EIE-FS-RDAVR costs $800 less than FS-AVR per surgery episode attributable to lowered complication rates and utilization. Combined with the lower mortality, EIE-FS-RDAVR was a superior (dominant) technology versus FS-AVR. CONCLUSION: This preliminary investigation of EIE-FS-RDAVR versus conventional FS-AVR found the EIE valve offered superior economic value over a 30-day period. Real-world analyses with additional long-term follow-up are needed to evaluate if this result can be replicated over a longer timeframe.

In-hospital cost comparison between percutaneous pulmonary valve implantation and surgery.

Objectives: Today, both surgical and percutaneous techniques are available for pulmonary valve implantation in patients with right ventricle outflow tract obstruction or insufficiency. In this controlled, non-randomized study the hospital costs per patient of the two treatment options were identified and compared. Methods: During the period of June 2011 until October 2014 cost data in 20 patients treated with the percutaneous technique and 14 patients treated with open surgery were consecutively included. Two methods for cost analysis were used, a retrospective average cost estimate (overhead costs) and a direct prospective detailed cost acquisition related to each individual patient (patient-specific costs). Results: The equipment cost, particularly the stents and valve itself was by far the main cost-driving factor in the percutaneous pulmonary valve group, representing 96% of the direct costs, whereas in the open surgery group the main costs derived from the postoperative care and particularly the stay in the intensive care department. The device-related cost in this group represented 13.5% of the direct costs. Length-of-stay-related costs in the percutaneous group were mean $3885 (1618) and mean $17 848 (5060) in the open surgery group. The difference in postoperative stay between the groups was statistically significant ( P ≤ 0.001). Conclusions: Given the high postoperative cost in open surgery, the percutaneous procedure could be cost saving even with a device cost of more than five times the cost of the surgical device.

Cost-effectiveness of self-managed versus physician-managed oral anticoagulation therapy.

BACKGROUND: Patient self-management of long-term oral anticoagulation therapy is an effective strategy in a number of clinical situations, but it is currently not a funded option in the Canadian health care system. We sought to compare the incremental cost and health benefits of self-management with those of physician management from the perspective of the Canadian health care payer over a 5-year period. METHODS: We developed a Bayesian Markov model comparing the costs and quality-adjusted life years (QALYs) accrued to patients receiving oral anticoagulation therapy through self-management or physician management for atrial fibrillation or for a mechanical heart valve. Five health states were defined: no events, minor hemorrhagic events, major hemorrhagic events, thrombotic events and death. Data from published literature were used for transition probabilities. Canadian 2003 costs were used, and utility estimates were obtained from various published sources. RESULTS: Self-management resulted in 3.50 fewer thrombotic events, 0.78 fewer major hemorrhagic events and 0.12 fewer deaths per 100 patients than physician management. The average discounted incremental cost of self-management over physician management was found to be 989 dollars (95% confidence interval [CI] 310 dollars-1655 dollars) per patient and the incremental QALYs gained was 0.07 (95% CI 0.06-0.08). The cost-effectiveness of self-management was 14,129 dollars per QALY gained. There was a 95% chance that self-management would be cost-effective at a willingness to pay of 23,800 dollars per QALY. Results were robust in probabilistic and deterministic sensitivity analyses. INTERPRETATION: This model suggests that self-management is a cost-effective strategy for those receiving long-term oral anticoagulation therapy for atrial fibrillation or for a mechanical heart valve.