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Archives of cardiovascular diseases
Volume 111, n° 8-9
pages 534-540 (août 2018)
Doi : 10.1016/j.acvd.2018.01.003
Received : 22 September 2017 ;  accepted : 22 January 2018
Clinical research

Is transcatheter aortic valve replacement a profitable procedure in a high-volume French hospital?
Le TAVI est-il une procédure rentable dans un centre hospitalier français à haut volume ?
 

François Huchet a, , Fanny d’Acremont b, Vincent Letocart a, Patrice Guerin a, Gael Grimandi b, Thibaut Manigold a
a Service de cardiologie, hôpital Nord-Laennec, CHU de Nantes, 44800 Saint-Herblain, France 
b Pharmacie centrale, hôpital Saint-Jacques, CHU de Nantes, 44093 Nantes, France 

Corresponding author. Service de cardiologie, unité d’hémodynamique et cardiologie Interventionnelle, hôpital Nord-Laennec, CHU de Nantes, boulevard Professeur-Jacques-Monod, 44800 Saint-Herblain, France.Service de cardiologie, unité d’hémodynamique et cardiologie Interventionnelle, hôpital Nord-Laennec, CHU de Nantes, boulevard Professeur-Jacques-Monod, 44800 Saint-Herblain, France.
Summary
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.

The full text of this article is available in PDF format.
Résumé
Contexte

Le remplacement valvulaire aortique percutané (TAVR) a révolutionné le pronostic des patients non opérables présentant une sténose aortique sévère. Le coût des prothèses implantées chez des patients comorbides pourrait être discutable à l’époque où les enjeux médico-économiques constituent une problématique majeure.

Objectif

L’objectif de cette étude était de déterminer la rentabilité du TAVR dans un hôpital français à grand volume d’activité.

Méthodes

Tous les patients consécutifs éligibles au TAVR transfémoral avec une bioprothèse SAPIEN (SAPIEN-XT ou SAPIEN 3 ; Edwards Lifesciences, Irvine, CA, État-Unis) entre septembre 2014 et décembre 2015 étaient inclus rétrospectivement dans cette étude monocentrique. Trois sous-groupes étaient constitués, selon le niveau de sévérité médico-économique. Le critère de jugement principal était la différence entre les coûts et les remboursements pour chaque séjour de patient. Les critères secondaires étudiaient les événements indésirables graves à 30jours et la répartition des coûts.

Résultats

Cent quatre vingt-neuf patients étaient inclus dans l’analyse. Au trentième jour, 3 patients étaient décédés (2 de causes non cardiaques). Le coût moyen s’élevait à €27 530±3814 pour un remboursement à €30 313±2681 par patient (p <0,001). Le critère de jugement principal démontrait un bénéfice significatif de €2783±1743 par patient pour un bénéfice total de €525 000 sur la période évaluée. Les patients présentant le plus faible niveau de sévérité généraient les bénéfices les plus importants. Le prix de la bioprothèse représentait 71 % du coût total.

Conclusions

Le TAVR transfémoral chez des patients sélectionnés est rentable pour le centre implanteur, indépendamment du niveau de sévérité du patient.

The full text of this article is available in PDF format.

Keywords : Transcatheter aortic valve replacement, Health economics, Cost benefit, Bioprosthesis

Mots clés : Remplacement valvulaire aortique percutané, Analyse médico-économique, Rentabilité, Bioprothèses

Abbreviations : GHM, ICU, TAVR


Background

In less than 15years, transcatheter aortic valve replacement (TAVR) has revolutionized the prognosis of patients who present with severe aortic valve stenosis and cannot undergo conventional surgery. A clear benefit has been demonstrated for TAVR versus medical treatment in randomized studies [1], and non-inferiority has been confirmed versus conventional surgery in high-risk patients [2]. Current guidelines [3, 4] support its use in severe symptomatic patients who are considered unsuitable for surgery, and recent studies are widening its use to patients with high-to-intermediate risk [5]. As a result, hospitals have to face a major increase in the number of TAVR procedures. In our centre, the implantation of percutaneous aortic bioprostheses almost equalled the implantation of conventional surgical bioprostheses in 2016, leading to unexpected costs and hospitalizations attributable to the treatment of patients previously denied invasive strategies.

TAVR prostheses are very expensive, and their implantation in elderly patients with comorbidities may be questionable in an era when healthcare costs are becoming a major concern. Cost-revenue analyses are rarely performed, although it can be anticipated that robust economic data analyses will be increasingly needed to inform future guidelines.

In France, the price of a surgical aortic valve is included in the surgical act reimbursement, whereas a percutaneous aortic bioprosthesis incurs an additional charge. In this context, the appreciation of profit in percutaneous bioprosthesis implantation is challenging, and we considered that there was a need for a strategic evaluation in our institution. Therefore, the objective of this study was to perform a cost-revenue analysis for the TAVR procedure in real-world patients managed in a high-volume French hospital.

Methods
Study population

Eligible patients were those scheduled to undergo transfemoral TAVR using the balloon-expandable SAPIEN 3 valve (Edwards Lifesciences, Irvine, CA, USA) at the University Hospital of Nantes, France, after an exhaustive preoperative appraisal by the heart team, and in accordance with the European Society of Cardiology guidelines [3]. All consecutive eligible patients identified between September 2014 and December 2015 were included retrospectively into the study. Clinical data were collected in our local database and were exported to the FRANCE-TAVI registry (managed by the French Society of Cardiology). All patients gave consent to the use of their data.

TAVR procedure and early follow-up

Transfemoral TAVR procedures were realized by two senior interventional cardiologists, as described previously [6]. Implantation of the SAPIEN 3 valve was preceded by balloon dilatation of the native aortic valve, and no post-dilatation was performed. A single dose of heparin (0.5mg/kg) was injected into all patients immediately after positioning the major transarterial access, without activated clotting time control. The antithrombotic regimen was delivered in accordance with current guidelines [3]. Systematic echocardiography was performed at the end of procedure and before hospital discharge, to check for successful implantation.

Patient subgroups

Medicoeconomic data were collected from the French National Health Society and from the Medical Programme of Information Systems (PMSI: Programme de médicalisation des systèmes d’information ). According to the French medicoeconomic classification system by diagnosis-related groups (GHM: Groupe homogène des malades ), patients receiving an aortic transfemoral bioprosthesis (Code 05K21) can be divided into four severity-level subgroups, depending mostly on medical background and in-hospital complications. In this study, patients presenting the highest level of severity (levels 3 and 4) were pooled for analysis because of similar medicoeconomic issues related to prolonged hospital length of stay, complications and prognosis.

Cost-revenue analysis

For each patient, we calculated the total cost of the TAVR procedure, and compared it with the reimbursement received by the hospital. The costs were assessed using the 2014 French National Scale of Health Costs, which are available online (enc-mco), and were dependent on length of hospital stay, development of early complications and requirement for a permanent pacemaker after the TAVR.

Four different costs were considered and totalled to provide a global cost per patient: the clinical cost, which included all costs related to the hospitalization unit (intensive care unit [ICU] and/or standard unit); the medicotechnical cost, which included all costs related to the TAVR procedure, pacemaker implantation (if performed) and standard laboratory and imaging tests (this cost also included the remuneration of doctors and nurses during the procedure, and the maintenance and depreciation costs of the equipment); the logistical cost, which included medical (pharmacy, hygiene) and general (laundry, nourishment, administration, patient handling) logistical costs; and the direct cost, which included the price of the device(s), medicines and consumables.

The cost of medical devices and blood products and the remuneration of doctors and nurses during the procedure were estimated for each patient using a microcosting analysis. The global incomes for the hospital were determined for each patient as the sum of three separate incomes: a standard reimbursement defined by the patient's severity level; a supplement for patients monitored in an ICU or reanimation unit; and a reimbursement of implanted devices.

Endpoints

The primary endpoint was the economic profit associated with the TAVR procedure. We estimated the profit by calculating the difference between costs and revenues associated with each patient.

The secondary endpoints were major adverse events within 30 days of the procedure, defined according to the Valve Academic Research Consortium (VARC)-2 criteria [7], and including major vascular complications, major/life-threatening bleeding, major adverse postoperative events (defined as stroke and/or myocardial infarction), early rehospitalization for heart failure, pacemaker requirement, tamponade and stage 3 acute kidney injury, analysed as separate endpoints; and breakdown of costs (clinical, medicotechnical, logistical and direct costs) for all patients and within severity-level subgroups.

Statistical analysis

Continuous variables are reported using means±standard deviations and were compared using Student's t test. We used the χ 2 test or Fisher's exact test to compare categorical variables. A two-sided P -value<0.05 was considered to indicate statistical significance. Comparisons between groups were performed using the analysis of variance (ANOVA) test, and the Bonferroni correction for multiple comparisons. Statistical analyses were performed with SPSS® software, version 20.0 (IBM Corp., Armonk, NY, USA).

Results
Study population

Between September 2014 and December 2015, 194 patients were prescribed transfemoral TAVR with SAPIEN bioprostheses by the heart team. Five patients were excluded from the analysis because of changes in GHM classification; two of these patients required urgent cardiac surgery. Three patients (1.6%) died within 30 days of the procedure. Causes of death were cardiac for one patient (annulus rupture during TAVR) and non-cardiac for two patients (both occurring after hospital discharge).

Baseline characteristics

Demographic and preoperative characteristics are presented in Table 1. The population included elderly patients with a balanced sex ratio. Dyspnoea was observed in most patients (179/189, 94.7%), without any alteration of left ventricular ejection fraction. There was no significant difference between the severity-level subgroups regarding demographic data and clinical status. A trend was observed for fewer comorbidities in patients in severity level 1, and chronic obstructive pulmonary disease was significantly less present in these patients. As expected, risk scores (EuroSCORE and Society of Thoracic Surgeons) were significantly more elevated for patients in severity level 3–4.

Procedure outcomes and length of stay

A total of 185 patients received a SAPIEN 3 prosthesis and four patients received a SAPIEN XT prosthesis during the study. Procedural data were similar between groups, regarding success of intervention, use of local anaesthesia (>90%), duration of procedure, radiation doses and main echocardiographic results (Table 2).

For patients in severity level 1, the length of stay in an ICU or hospital after the TAVR procedure was significantly lower than for patients in severity levels 2 or 3–4.

Primary endpoint

The mean cost per patient for the TAVR procedure was €27,530±3814, and the mean revenue per patient was €30,313±2681 (P <0.001). The difference between cost and revenue resulted in a significant profit of €2783±1743 per patient, and an overall profit estimated at €525,000 for the institution.

The profit associated with the TAVR procedure by severity-level subgroup is presented in Figure 1. Profit was generated from all severity-level subgroups and was minimum for patients in severity level 3–4 (€1286±2376 per patient). Loss was observed for five patients (4.1%) in level 2 and for eight patients (27.6%) in level 3–4.



Figure 1


Figure 1. 

Profit analysis by severity-level subgroup. GHM: groupe homogène des malades (diagnosis-related group). * P <0.05 versus level 2; ** P <0.001 versus level 3–4.

Zoom

Secondary clinical endpoint: major adverse events

Major adverse events within 30 days of the procedure are presented in Table 3. Patients in severity level 1 did not present any major complications, which is in line with a level 1 classification. The comparison between patients in level 2 and those in level 3–4 showed no significant difference regarding the requirement for a permanent pacemaker, onset of myocardial infarction or any major vascular complications. Yet, the patients in level 2 experienced significantly fewer disabling strokes (0 [0%] vs. 2 [6.9%]; P =0.04), fewer life-threatening or major bleedings (8 [6.5%] vs. 7 [24.1%]; P <0.001) and fewer transfusion requirements (4 [3.3%] vs. 8 [27.5%]; P <0.001).

Secondary economic endpoint: cost-revenue analysis

The overall breakdown of costs is presented in Figure 2. The majority of costs (80%) were direct costs, mostly driven by the price of the bioprosthesis, representing 71% of the total cost and 93% of device-related costs. Logistical and medicotechnical costs contributed little to the overall cost (≤6% each).



Figure 2


Figure 2. 

Overall breakdown of costs.

Zoom

The breakdown of costs in severity-level subgroups are presented in Table 4. All costs were significantly lower for patients in severity level 1, except the clinical cost versus patients in severity level 2. Direct costs did not differ between patients in level 2 and those in level 3–4. The medicotechnical and logistical costs increased with the patients’ level of severity. The clinical costs were significantly increased in patients in severity level 3–4.

Discussion

To our knowledge, this is the first study conducting a cost-revenue analysis of the TAVR procedure with the new generation of balloon-expandable prostheses (SAPIEN 3 valve). Our cohort included a significant number of real-world patients, leading to robust results suggesting that TAVR is a profitable procedure.

The study population, of whom the majority were elderly patients with comorbidities, is representative of current practice. Despite age and comorbidities, most patients presented a moderate level of severity, associated with a favourable prognosis after TAVR, as a result of careful and multidisciplinary selection [8, 9].

Our clinical results with the SAPIEN prostheses are in accordance with recent studies and registries [10, 11]: procedural success was high (189/194, 97.4%); only one patient died from a cardiac cause at 1 month (1/189, 0.5%); and no moderate or severe aortic regurgitation was observed. The incidence of major vascular complications was low (8/189, 4.2%), as expected with the new generation of prostheses [12].

The rate of pacemaker implantation in our cohort did not differ from that reported in recent studies and registries using the SAPIEN 3 valve [11]. The pacemaker device was reimbursed to the hospital, and with staff-related costs (doctors and nurses) representing<5% of total costs, the implantation of a pacemaker had a limited impact on total costs. Our current national legal framework specifies that three physicians (including an anaesthesiologist) should be present for a TAVR procedure. However, the trend towards an increase in less invasive procedures may reduce the requirements for medical personnel in the near future, leading to a cost reduction. As described previously by others [13], all procedures were realized using a minimalist approach, involving local anaesthesia in the catheterization laboratory, which contributed to keeping costs down.

The percutaneous implantation of an aortic bioprosthesis is associated with a reduction in hospital length of stay compared with conventional surgery, especially in elderly patients with comorbidities who have suitable transfemoral access [14]. This observation is all the more important given that the patients’ level of severity was low in our cohort. Although the clinical costs accounted for only 9% of total costs, any reduction in hospital length of stay is expected to benefit the institution, as long as the hospital length of stay remains within the GHM parameters. Recent studies have considered the possibility of discharging patients within a few days of a TAVR procedure [15, 16], which may further increase the profit generated from the procedure if the lower parameter of the GHM is adopted by the national health authorities. Moreover, the expected expanded indication to intermediate-risk patients in forthcoming guidelines may increase the volume of patients in severity level 1, who are associated with maximal profit.

A large part of the procedure's overall cost was attributable to the price of the bioprosthesis. The impact of the direct cost was significantly higher in patients presenting a lower severity level, amounting to 85% of total costs. In our point of view, and in accordance with medicoeconomic concerns, a reduction in the total cost of the TAVR procedure will require a significant reduction in the price of the device in the first place. This is all the more important, given that the price of the device was set by health authorities several years ago, when patients eligible for TAVR were very different from those currently undergoing the procedure.

Study limitations

Our study has several limitations. It was a single-centre study, but this limitation was balanced by high volume and use of standard patient recruitment. The hospitalization costs and revenues were calculated after medical appraisal of the patients’ severity level, and may have been underestimated as a result of human errors in the listing process. Regardless of these limitations, the TAVR procedure was found to be highly profitable for the hospital.

Conclusions

This study demonstrates that percutaneous balloon-expandable aortic valve implantation is a profitable procedure in an academic high-volume hospital. The profit was consistent, regardless of the patients’ GHM severity level, and was maximal for patients with a low severity level. A large part of the cost was related to the price of the bioprosthesis, and a reduction in the total cost of the TAVR procedure will only be achieved with a significant decrease in the prosthesis price.

Sources of funding

This research was partially funded by Edwards Lifesciences.

Disclosure of interest

The authors declare that they have no competing interest.

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