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.

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 of complex abdominal wall reconstruction with biological prostheses in a French public hospital.

GOAL: Retrospective analysis of bioprosthetic abdominal wall reconstruction in our center with regard to expenses and reimbursement. PATIENTS AND METHODS: This study included all patients undergoing bioprosthetic abdominal wall reconstruction between 2009 and 2015. All costs were considered in determining the hospital expenditures. Next we compared the incoming revenue for each hospital stay based on disease-related groups (DRG) and additional daily hospital fees. RESULTS: Seventy-six patients underwent abdominal wall reconstruction, 67 of whom had economical data that were exploitable. On the average, our center lost €15,233 for every hospital stay associated with bioprosthetic abdominal wall reconstruction. The existing DRG system is not well adapted to provide adequate reimbursement for costs related to complex abdominal wall repairs, especially when post-operative morbidity leads to prolonged hospital stay and increased expenses. CONCLUSION: Abdominal wall repairs with bioprostheses are expensive and are poorly reimbursed in the French Health care system, mainly because they are often associated with complications that increase the costs considerably. In our opinion, it seems necessary that either reimbursement of this type of prosthesis should be higher than the current DRG allows, or that the DRG classification be redefined, or even, that a specific DRG be created for complex abdominal wall reconstruction.

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.

A low-cost bioprosthetic semilunar valve for research, disease modelling and surgical training applications.

OBJECTIVES: This paper provides detailed instructions for constructing low-cost bioprosthetic semilunar valves for animal research and clinical training. This work fills an important gap between existing simulator training valves and clinical valves by providing fully functioning designs that can be employed in ex vivo and in vivo experiments and can also be modified to model valvular disease. METHODS: Valves are constructed in 4 steps consisting of creating a metal frame, covering it with fabric and attaching a suture ring and leaflets. Computer-aided design files are provided for making the frame from wire or by metal 3D printing. The covering fabric and suturing ring are made from materials readily available in a surgical lab, while the leaflets are made from pericardium. The entire fabrication process is described in figures and in a video. To demonstrate disease modelling, design modifications are described for producing paravalvular leaks, and these valves were evaluated in porcine ex vivo (n = 3) and in vivo (n = 6) experiments. RESULTS: Porcine ex vivo and acute in vivo experiments demonstrate that the valves can replicate the performance of clinical valves for research and training purposes. Surgical implantation is similar, and echocardiograms are comparable to clinical valves. Furthermore, valve leaflet function was satisfactory during acute in vivo tests with little central regurgitation, while the paravalvular leak modifications consistently produced leaks in the desired locations. CONCLUSIONS: The detailed design procedure presented here, which includes a tutorial video and computer-aided design files, should be of substantial benefit to researchers developing valve disease models and to clinicians developing realistic valve training systems.

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.

Outcomes After Auro Keratoprosthesis Implantation: A Low-Cost Design Based on the Boston Keratoprosthesis.

PURPOSE: To evaluate outcomes after Auro keratoprosthesis (kpro) implantation. METHODS: Retrospective observational case series. The records of all patients who were implanted with Auro kpro from December 2012 to August 2015 at a single institute were retrospectively analyzed to evaluate preoperative characteristics, postoperative outcomes, and complications. RESULTS: Fifteen cases were included in the study. Failed graft was the most common indication for the surgery (n = 14; 93.3%). The mean BCVA (Log MAR) improved from 2.20 ± 0.43 in the preoperative period to 1.46 ± 1.12 (P = 0.0247) at the mean final follow-up of 13.5 months. The best corrected visual acuity (BCVA) improved to 20/200 or better in 9 patients (60%) at the final follow-up. Postoperative complications included retroprosthetic membrane formation (n = 7; 46.7 %), graft infection (n = 4; 26.7%), sterile corneal melt (n = 3; 20%), and spontaneous optic extrusion (n = 1; 6.7%). Eleven patients retained prosthesis at the final follow-up (retention rate = 73.3%). CONCLUSIONS: Auro kpro seems to be effective in treating end-stage corneal diseases. The outcomes are comparable to Boston kpro in terms of visual acuity, postoperative complications, and retention rates.

Cost of Stem Cell-Based Tissue-Engineered Airway Transplants in the United Kingdom: Case Series.

Stem cell-based tissue-engineered tracheas are at an early stage in their product development cycle. Tens of patients have been treated worldwide in predominantly compassionate use settings, demonstrating significant promise. This potentially life-saving treatment is complex, and the cost and its implications for such treatments are yet to be fully understood. The costs are compounded by varying strategies for graft preparation and transplant, resulting in differing clinical and laboratory costs from different research groups. In this study, we present a detailed breakdown of the clinical and manufacturing costs for three of the United Kingdom (UK) patients treated with such transplants. All three patients were treated under Compassionate Use legislation, within the UK National Health Service (NHS) hospital setting. The total costs for the three UK patients treated ranged from $174,420 to $740,500. All three patients were in a state of poor health at time of treatment and had a number of complexities in addition to the restricted airway. This is the first time a cost analysis has been made for a tissue-engineered organ and provides a benchmark for future studies, as well as comparative data for use in reimbursement considerations.

Assessing complications and cost-utilization in ventral hernia repair utilizing biologic mesh in a bridged underlay technique.

BACKGROUND: The inability to reapproximate fascia in complex ventral hernia (CVH) repair remains challenging. Single-stage bridging reconstructions have been reported, however, with high rates of recurrence and wound complications. We describe a single-surgeon experience with bridging biologic CVH repair. METHODS: We reviewed 37 patients undergoing CVH repair with bridging biologic mesh by the senior author from January 1, 2007 to January 1, 2013. Surgical history and operative characteristics were analyzed for predictors of hernia recurrence and wound complications. RESULTS: Average age was 53 ± 15 years, body mass index was 31.1 ± 8.1 kg/m(2), and history of prior repair in 18 patients. Common indications were trauma, intra-abdominal infection, and prior intra-abdominal surgery. Incidence of wound complications was 51.4%, most commonly wound breakdown and infection. With average follow-up of 13 months, recurrence rate was 18.9% at an average of 8.2 months postoperatively. Analysis demonstrated postoperative wound infection as the only predictor of recurrence (odds ratio = 22.1, P = .017). CONCLUSIONS: Hernia recurrence rate was 18.9% with bridged biologic CVH repairs, strongly associated with postoperative wound infection. This suggests that patients with postoperative infections may benefit from closer surveillance and more aggressive wound management.

Clinical outcomes of biologic mesh: where do we stand?

After review and evaluation of current clinical data, including significant wound complications, a noteworthy failure rate at 1 year, and high product costs, it is difficult to support the continued use of biologic meshes in incisional hernia repair outside of well-designed and rigorously conducted clinical trials. An industry-sponsored, publicly available registry of biologic prosthetic use for ventral hernia repairs is needed. This straightforward mandate, if properly constructed and implemented, would significantly expand knowledge regarding how these intriguing biomaterials are used and their overall clinical efficacy, thus yielding a more robust basis for the continued use of biologic prosthetics in hernia repair than is currently available.

Cost-effectiveness of mitral valve repair versus replacement by biologic or mechanical prosthesis.

BACKGROUND: Surgical treatment strategies for mitral valve disease have progressively shifted toward repair given the better survival outcomes with this type of intervention. However, valve repairs and valve replacement may require reoperations with time. In the absence of clinical trials assessing the effectiveness of various mitral surgical treatments with time, we propose to develop cost-effectiveness models to compare sequential treatment strategies. METHODS: Three simulation models were carried out to assess the cost-effectiveness of mitral valve repair as first-line treatment, compared with either mechanical or biologic valve replacements. Efficacy data were derived from both the published literature and from a specific clinical cohort of 582 patients treated for this condition. Using the French public health care system perspective, relevant direct costs were derived using a local resource utilization assessment and official costing data sources. RESULTS: Over 10 years, costs per success were significantly lower (p < 0.01) for the mitral valve repair strategy versus biologic or mechanical valve replacements (€35,550, €49,492, and €54,634 per success, respectively). Over 20 years, costs per success were significantly lower (p < 0.01) for the mechanical valve replacement strategy compared with the mitral valve repair and biologic valve replacement (€94,763, €100,053, and €147,484 per success, respectively). CONCLUSIONS: Considering the increased referral rate in older patients with degenerative mitral valve disease, and their shorter life expectancy, these results show that when medically required and technically practicable, mitral valve repair should be considered as the first-line strategy.

Outcomes using a bioprosthetic mesh at the time of permanent stoma creation in preventing a parastomal hernia: a value analysis.

PURPOSE/METHODS: A retrospective review of the medical records of all patients who had a prosthetic placed at the time of stoma creation for the prevention of a parastomal hernia was performed. The purpose of this study was to evaluate the safety, efficacy, and cost-effectiveness of bioprosthetics. RESULTS: A bioprosthetic was used in 16 patients to prevent the occurrence of a parastomal hernia. The median follow-up was 38 months. There were no mesh-related complications, and no parastomal hernias occurred. On value analysis, to be cost-effective, the percentage of patients who would have subsequently needed surgical repair of a parastomal hernia would have to be in excess of 39% or the bioprosthetic would have to cost less than $2,267 to $4,312. CONCLUSIONS: These data show the safety and efficacy of using a bioprosthetic at the time of permanent stoma creation in preventing a parastomal hernia and defines the parameters for this approach to be cost-effective.

[The cost of innovation in treating aortic stenosis: transcatheter aortic valve implantation]. / Il costo dell'innovazione nel trattamento della stenosi aortica: l'impianto transcatetere di protesi valvolare aortica.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) represents a promising therapeutic option for patients affected by severe aortic stenosis, but it is currently associated with high costs. Therefore, the assessment of its economic impact becomes urgent to support decision-makers' choices about its use, patient access to treatment and reimbursement mechanisms. METHODS: A retrospective, observational, single-center (the teaching hospital located in Bologna, Italy) study was conducted. All patients with severe symptomatic aortic stenosis undergoing TAVI during the enrolment period (February 2008-August 2010) were included. The procedures were performed with both bioprostheses approved for clinical use and through different vascular access: CoreValve transfemoral (CV-TF), CoreValve transsubclavian (CV-TS), Edwards Sapien transapical (ES-TA), Edwards Sapien transfemoral (ES-TF). Costs of the whole index hospitalization have been calculated from the hospital perspective. Healthcare resource consumption was measured at patient level and assessed using unit costs (micro-costing approach). RESULTS: Overall, 87 consecutive patients (48 CV-TF, 12 CV-TS, 20 ES-TA, 7 ES-TF) were included in the study. They presented a high-risk profile (age 83.3 ± 5.4 years; logistic EuroSCORE 23.3 ± 12.3%) and important comorbidity. In-hospital mortality was 3.4%. Total cost of hospitalization was, on average, €35.841 (range €27.267-69.744) of which 68% was attributable to the procedure. A huge variation in costs was observed among different treatment groups. Patients treated with transfemoral implant (CV-TF: €33.977; ES-TF: €31.442) were on average less expensive than others (CV-TS: €37.035; ES-TA: €41.139). CONCLUSIONS: Our findings show that treating patients with TAVI places a heavy burden on hospital budget. Hence, due to the shortage of financial resources, affordability of TAVI requires further attention.

Technology insight: the evolution of tissue-engineered vascular grafts--from research to clinical practice.

There is a considerable clinical need for alternatives to the autologous vein and artery tissues used for vascular reconstructive surgeries such as CABG, lower limb bypass, arteriovenous shunts and repair of congenital defects to the pulmonary outflow tract. So far, synthetic materials have not matched the efficacy of native tissues, particularly in small diameter applications. The development of cardiovascular tissue engineering introduced the possibility of a living, biological graft that might mimic the functional properties of native vessels. While academic research in the field of tissue engineering in general has been active, as yet there has been no clear example of clinical and commercial success. The recent transition of cell-based therapies from experimental to clinical use has, however, reinvigorated the field of cardiovascular tissue engineering. Here, we discuss the most promising approaches specific to tissue-engineered blood vessels and briefly introduce our recent clinical results. The unique regulatory, reimbursement and production challenges facing personalized medicine are also discussed.

Comparison of mersilene mesh-methyl metacrylate sandwich and polytetrafluoroethylene grafts for chest wall reconstruction.

We report the outcomes of patients who underwent reconstruction with Mersilene mesh-methyl methacrylate (MM-MM) sandwich and polytetrafluoroethylene (PTFE) grafts after a large chest wall resection. Between June 1990 and September 2001, 59 consecutive patients (37 men, 22 women; mean age, 48.1 +/- 11.8 years; range 22-74 years) underwent large chest wall resection (greater than 5 cm diameter) and reconstruction with prosthetic material in our department. Twenty-one patients (33%) underwent reconstruction with a PTFE graft (group 2) between 1990 and 1994, and 38 patients (67%) underwent reconstruction with an MM-MM sandwich graft (group 1) between 1994 and 2001. Operative morbidity ratios were 5.2% (2/38) in group 1 and 24% (5/21) in group 2 (p = .036). The paradoxical respiration ratio was significantly higher (p = .018) in group 2 (5/21: 24%) than it was in group 1 (1/38: 2.6%). The operative mortality ratio was 4.5% (1/21) in group 2 and 0% in group 1. Mean hospital stay was 10.6 days (range 5-21 days) in group 1 and 13.3 days (range 7-36 days) in group 2 (p = .015). The MM-MM graft is inexpensive and easy to apply, provides better cosmetic options, and offers minimal morbidity. We therefore recommend that the MM-MM sandwich graft be used rather than the PTFE graft for large defects of the anterolateral chest wall and sternum where successful prevention of paradoxical respiration is required.

An economic survey of the emerging tissue engineering industry.

The contemporary scope of worldwide tissue engineering research and development was estimated by totaling the relevant annual spending and other economic parameters of firms involved the field. Operating expenses allocated to tissue engineering in 1997 exceed $450 million and fund the activities of nearly 2,500 scientists and support personnel. Growth rate is 22.5% per annum. Most activity is centered in the United States. Government spending in this field represents <10% of the total. The aggregate capital value of start-ups that have gone public was approximately $1.7 billion as of January 1, 1998; total capital value of all firms and business units in the field was estimated to be roughly $3.5 billion. The level of investment and valuation represents a remarkable act of faith in the future of a technology yet to produce its first significant revenue-generating product.

Valve data collection: problems and pitfalls.

Since 1981, the Department of Medical Physics and Clinical Engineering at the University of Sheffield has been responsible for the organization, management and data collection associated with the largest multicentre heart valve implant patient follow-up study in the Western world. At the present time, the database comprises information on over 16,000 valve implants, which have been provided by 57 surgeons working at 22 centres in the UK. All this data is available for in-depth statistical analysis. Over 30 individual valve models presently are included in the Study and these can be categorized into five main types: ball, disc, porcine, pericardial and homograft. Analysis includes descriptive statistics as well as valuable information on the various performances of the different valves. Survival and event-free survival graphs are obtained by actuarial methods and individual valve types can be studied in depth in terms of freedom from thromboembolic complications and valve dysfunction. Whilst this approach provides interesting and valuable survival data, it does not take account of the wide variation in prognostic factors which occur within large groups of patients. This latter problem can be addressed by the use of proportional hazards analysis and this paper provides details of this approach and typical results obtained from the use of this method. These include the comparative performances of the major types of valves currently in use in terms of the event-free survival of the patients.