Robot-assisted laparoscopic prostatectomy - Epidemiology ...

Epidemiology Biostatistics and Public Health - 2015, Volume 12, Number 1

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Robot-assisted laparoscopic prostatectomy: an economic analysis for decision-making in a university hospital of Northern Italy Elisa Fabbro(1), Simone Crivellaro(2), Chiara F. Dalle Fratte(3), Luigi Vetrugno(4), Gianluigi Adani(5), Barbara Saule(6), Daniela Drigo(1), Giulia Zumerle(7), Carlo Favaretti(8), Giovanni M. Guarrera(9)

Background: Robotic Assisted Radical Prostatectomy (RALP) is one of the most expensive urological innovations. Prices of the “Da Vinci System” range from € 761,105 to € 1,902,762 for each unit, without taking into account the cost of maintenance and the use of additional devices. We evaluated outcomes, and costs retrospectively, comparing RALP to open retro-pubic radical prostatectomy (RRP) performed in our hospital between December 2009 and December 2010. Methods: We compared 53 RALPs, and 50 RRPs in terms of costs, and clinical outcomes. We also implemented a Break Even Analysis in order to evaluate if the public reimbursement covered the total cost of RALP. Results: According to our analysis, RALP showed lower hospitalization (p < 0.0001), higher early continence rate (p < 0.0001), better potency rate in nerve sparing procedures (p < 0.0142), and required no transfusions. Excluding the cost of purchasing and maintenance, single case costs were € 6,046.08 for RALP and € 4,834.11 for RRP, respectively. Considering the affordability of the technology, the point where the total revenue is sufficient to cover the total costs is an average of 60 cases performed per year, only in presence of additional reimbursement. ConclusionS: Although our clinical analysis shows better results in favour of RALP, the economical analysis shows that RALP's costs are consistently higher than RRP. Considering also the purchasing costs, we demonstrated that the health gain of the technology does not necessarily offset the higher costs, even in a large, university hospital (1,000 beds).

Key words: Robotic; Prostate cancer; Radical prostatectomy, Heath economic evaluation (1) Department of Medical and Biological Sciences University of Udine, Udine Italy (2) Department of Urology, University Hospital of Udine, Udine Italy (3) Health Care Trust, Trento, Italy (4) Department of Anaesthesiology and Intensive Care, University Hospital of Udine, Udine, Italy (5) Department of Surgery & Transplantation, University Hospital School of Medicine, Udine, Italy (6) Department of Industrial and Information Engineering, University of Trieste, Trieste, Italy (7) Head of Planning and Control Department, University Hospital of Udine, Italy

(8) Centre for Leadership in Medicine, Department of Public Health, Catholic University of the Sacred Heart, Rome, Italy (9) Medical Director, Health Care Trust, Trento, Italy

Corresponding author: Elisa Fabbro, Department of Medical and Biological Sciences, University of Udine, Udine Italy, Via Colugna 50, Udine, Italy; telephone: 0039 0432 559179; e-mail: [email protected]

DOI: 10.2427/10234 Accepted on December 3, 2014

Robotic Prostatectomy: a costs analysis

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INTRODUCTION According to the World Health Organization, in 2012 prostate cancer was estimated being the fourth most common cause of death from cancer in men with about 307,000 deaths worldwide [1]. In Europe, in 2009 the total numbers of prostate deaths were 69,069 while the predicted number of deaths for the year 2013 was 70,347 (95% Confidence Interval, 69,596-71,099) [2]. Radical prostatectomy remains the surgical treatment of choice for clinically localized prostate cancer. Since the first paper regarding the use of robotics in urology was published in 1989, the “Da Vinci System” has gained widespread popularity as the procedure selected by patients and surgeons for the treatment of prostate cancer [3]. The first generation of “Da Vinci System” is a robotic surgical device designed by Intuitive Surgical System in 1995, and subsequently approved by the Food and Drug Administration. Briefly, the machine consists of thin robotic arms (generally three or four) inserted into strategically placed incisions; the surgeon operates seated at a console unit with a 3D high-definition view of the surgical field [3]. Today the system allows surgeons to achieve a better perioperative outcome after a short training period [4,5]. Up to December 31, 2012, 2,585 Da Vinci Systems have been installed in over 2,025 hospitals worldwide. Its use has rapidly increased, and between 2007 and 2009 the cases treated with this technology tripled from 80,000 to 205,000. Approximately 450,000 Da Vinci procedures were performed in 2012, increased by approximately 25% compared to 2011. (Intuitive Surgical data, Sunnyvale CA; USA). Although it has been developed to facilitate, and make the minimally invasive surgical approach safer, the “Da Vinci System” is one of the most expensive technologies: its purchase price ranges from € 761,105 to € 1,902,762 for each unit; the yearly maintenance fee ranges from € 76,110 to € 152,221. To this sum, one must add the variable costs of machine maintenance, additional consumables and costs related to surgical times that are longer than traditional surgery [6,7,8]. So, the first aim of our study was to evaluate the costs and outcomes comparing robot assisted laparoscopic prostatectomy (RALP) and open retro-pubic radical prostatectomy e10234-2

(RRP) performed at our centre which is a large, university hospital (1,000 beds). Moreover, after an extensive review of the literature, we compared our clinical results and costs with data reported to date.

METHODS A total of 53 patients undergoing RALP and 50 patients undergoing RRP during the study period (December 2009 – December 2010) were retrospectively enrolled. Total costs (amortisation, maintenance service, consumable equipment, surgical and anaesthesia equipment), and clinical outcomes (length of hospital stay (LOS), continence rate and potency rate) were evaluated. Elective RRP was defined as the open radical prostate removal according to the retrograde technique described by Walsh et coll. [9]. Elective RALP was defined as robotic assisted laparoscopic radical prostate removal according to the technique described by Patel et al. [10]. In our hospital RALP is performed with the three arm “Standard Da Vinci System” (IS 1200). Inclusion criteria were: age < 75 years old, diagnosis of clinically localized prostate cancer, pre-operative prostate specific antigen (PSA) < 10 ng/ml, and Gleason Score ≤ 8; exclusion criteria were: closed glaucoma, history of unstable coronary syndrome or uncompensated heart disease. Before surgery, patients underwent routine clinical evaluation, including detailed medical history, physical evaluation, routine laboratory tests, 12-lead electrocardiography, and chest radiography. Clinically stable patients with coronary artery disease proceeded to surgery without any further non-invasive testing in accordance with the recommendations proposed by the American Heart Association/ American College of Cardiology Task Force [11]. During surgery, standard monitoring consisted of 2-lead electrocardiography (II/ V5), pulse oximetry, invasive systemic arterial pressure measurement (Philips IntelliVue MP70, Boeblingen, Germany), and gas analysis (KION, Siemens Elema, Solona, Sweden). The radial artery catheterization was performed before the induction of anaesthesia. Standardized general anaesthesia was induced with propofol (0.5 mg/kg), cisatracurium besylate (0.15 mg/kg), and fentanyl (0.3 to 0.5 mg) or remifentanil (0.25-0.35 mcg/Kg/min).



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Maintenance was performed with 0.8%1.5% end-tidal sevofluorane and remifentanil continuous infusion (0.10-0.35 mcg/Kg/ min). The surgical duration was recorded. Transfusions were managed according to the American Society of Anaesthesiologists guidelines [12]. At the end of surgery, patients underwent successfully tracheal extubation were transferred to the ward. At the end of surgery, all patients underwent successfully tracheal extubation and were transferred to the floor. Postoperative pain management included multimodal approach with Paracetamol and non-steroidal anti-inflammatory drugs, and intravenous morphine, (0.1 mg/Kg) 30 minutes before the end of surgery. Intraoperative data collection included details of surgery, anaesthesia and the complications experienced until hospital discharge. Clinical and pathological data of patients were collected retrospectively from the information system of the hospital. Operative features comprised nerve sparing and transfusion rate. Comparisons of LOS day distributions within two study treatment groups were performed by Wilcoxon – Mann – Whitney non-parametric tests. The Chi-square test was used to evaluate differences in the incontinence rates between the two groups at one and three months after treatment, while the Fisher

test was used to evaluate the difference of preserved potency frequency after surgery. The level of significance (alfa) in this study was 0.05. All statistical analyses were performed with SAS v.9.2 (SAS Institute Inc., Cary, NC, USA). The Propensity Score was calculated taking into account the age of the patient, the Gleason Score and PSA. The multiple logistic regression, including the propensity score as a covariate, was used to predict the following clinical outcomes: minor and major complications, readmissions, 1 and 3 months continence rate and potency. The clinical outcomes were evaluated as following: 1. Assessment of continence: number of pushed pads : 0-1 safety pad/day: continent , > 1 pads/day: incontinent 2. Complications: classified according to the Clavien and Dindo classification of surgical complications (Grade I and II minor complications, Grade III and IV major complications) (13). (Table1) The cost of purchase of the the “Da Vinci System” is € 1,490,821. It was amortised during 11 years, resulting in a yearly cost of €135,529.182. Furthermore, annual maintenance costs (€ 174,996) and costs for structural adjustments (€ 2,727.27 per year) have to be considered. Thus, total fixed costs amount to € 313,525.45 per year.

table 1 CLAVIEN AND DINDO CLASSIFICATION OF SURGICAL COMPLICATIONS Grades Definitions Grade I

Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic and radiological interventions. Acceptable therapeutic regimens are: drugs such as antiemetics, antipyretics, analgesics, diuretics and electrolytes, and physiotherapy. This grade also includes wound infections opened at the bedside.

Grade II

Requiring pharmacological treatment with drugs other than those allowed for grade I complications. Blood transfusions and total parenteral nutrition are also included.

Grade III

Requiring surgical, endoscopic or radiological intervention

Grade III-a

Intervention not under general anaesthesia

Grade III-b

Intervention under general anaesthesia

Grade IV

Life-threatening complication (including CNS complications: brain haemorrhage, ischaemic stroke, subarachnoid bleeding, but excluding transien schaemic attacks) requiring IC/ICU management

Grade IV-a

Single organ dysfunction (including dialysis)

Grade IV-b

Multi-organ dysfunction

Grade V

Death of a patient


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For the economic evaluation we analysed also the direct cost of consumable equipment, surgical and anaesthesia equipment, operating room, staff, and transfusion costs. Information regarding all costs was made available by the Control Department. To evaluate if the public reimbursement for the procedure covered the cost of RALP, we used the Break Even Analysis. This enabled us to determine the point where the total revenue is just sufficient to cover the total costs. According to its definition, at Break Even Point sales are equal to fixed costs plus variable costs. Thus, at this point, costs, or expenses and revenues are equal, indicating the level of sales at which profit is approximately zero. This concept is further explained by using the following formula: Q = FC / (UP - VC) where: Q = Break-Even Point, FC = Fixed Costs, VC = Variable Costs per Unit, UP = Unit Price; therefore, Break-Even Point Q = Fixed Cost / (Unit Price - Variable Unit Cost). Consequently, the Break Even Point is a useful indicator to determine when it is affordable to introduce a new technology or maintain an old one.

RESULTS Clinical outcomes The clinical and pathological data of the patients are shown in Tables 2a-2b and 3. Mean (SD) and median (IQR) values for age, PSA, Biopsy Gleason Score and LOS for every treatment group are reported in Table 2a. Baseline characteristics are similar between the two study groups, except for the level of PSA and the percentage of Gleason Score, with more patients with higher PSA and Gleason grading in the RRP group (Tables 2a-2b). When we compared the LOS within the two treatment groups, a significant difference was shown (p < 0.0001), as LOS was lower in the RALP (3.1; SD 0.9) compared to the RRP group (5.02; SD 0.8). No transfusions were required in the RALP group, while in the RRP group the mean number of red blood cell units transfused was 2.5, with 29 out of 50 (58%) of patients requiring transfusions. No significant differences were found for minor and major complications and for readmissions at the hospital within the two e10234-4

groups. Respectively, one patient (1.9%) after RALP and 5 (10%) after RRP were readmitted to the hospital. Major complications occurred in 2 out of 53 (3.8%) cases after RALP and in 4 out of 50 (8 %) cases after RRP. RALP group had a higher continence rate than RRP both at one and at three months, with a highly statistically significant difference (p < 0.0001). The nerve sparing technique was performed in 16 out of 23 (69%) subjects who underwent RALP and in 10 out of 20 (50%) patients receiving RRP (p = 0.01). The multivariate analysis identified a higher probability to have urinary incontinence at 1 and 3 months respectively of 36% and 16 % for patients treated with RRP; the readmissions resulted statistically significant (p