Perioperative and economic analysis of surgical treatments for benign prostatic hyperplasia: A study of the French committee on LUT

25 mai 2017

Auteurs : R. Mathieu, S. Lebdai, J.N. Cornu, A. Benchikh, A.R. Azzouzi, N.B. Delongchamps, O. Dumonceau, A. Faix, M. Fourmarier, O. Haillot, B. Lukacs, V. Misrai, A. de La Taille, G. Robert, A. Descazeaud
Référence : Prog Urol, 2017, 6, 27, 362-368




 




Introduction


With a high prevalence in industrialized countries, lower urinary tract symptoms (LUTS) due to benign prostatic obstruction (BPO) is a major public health concern [1]. Transurethral resection of the prostate (TURP) and open prostatectomy (OP) are standard procedures recommended by the European Association of Urology (EAU) for the surgical treatment of BPO [2]. During the last decade, minimally invasive surgical techniques, including photoselective vaporization of the prostate (PVP), holmium laser enucleation (HoLEP) and thullium laser enucleation (ThuLEP) have been introduced as alternatives to TURP and OP. Numerous studies have established that these techniques are safe and effective based on midterm follow-up [3].


New techniques may be associated with an increased cost in terms of equipment and consumables use. However, these additional costs may be balanced by shorter hospital stay and other improvements in perioperative care. Cost effectiveness of these new techniques still remains questionable and is a critical issue in an era of cost savings for healthcare systems.


The objective of this study was to assess perioperative cost related to surgical treatment of BPO.


Methods


Study design and population


Nine academic or private institutions in France participated in this retrospective study. In each center, data from 20 to 30 consecutive patients who underwent a surgical treatment for LUTS related to BPO between January 2012 and June 2013 were collected. All patients met criteria for surgery according to the guidelines of the EAU or the French Association of Urology [2, 4]. Patients with a neurogenic bladder or past history of urethral stricture or prostate cancer were excluded.


The following data were collected in a computerized database:

age;
ASA score;
prostate volume on transrectal ultrasound (TRUS);
urinary retention before surgery;
co-morbidities and anticoagulation therapy.


We evaluated perioperative parameters including operative time, length of hospital stay (LOS) and intra and postoperative complications (graded according to Clavien-Dindo's classification). Complications were defined as any abnormal medical or surgical event occurring within 30 days after surgery [5].


Procedures


TURP was performed using monopolar technology. PVP was performed using a Greenlight® laser 180 W-XPS (AMS, Minnetonka, MN, USA) with a moxy fiber. Sodium chloride solution (0.9%) was used as irrigation fluid. Generator was usually provided for free to the institution. During procedure, overcost compared to TURP was considered to be the use of a single moxy fiber; 700 € per procedure according to the manufacturer charge policy. ThuLEP and HoLEP were performed using the 100W holmium laser generator manufactured by Lumenisâ„¢ and the Piranhaâ„¢ morcellator manufactured by Richard Wolfâ„¢. Sodium chloride solution (0.9%) was used as irrigation fluid. Generators and morcellators were usually provided for free to the institution. During procedure, overcost compared to TURP was considered to be the use of a reusable laser fiber and blades of the morcellator; 70 € per procedure according to the manufacturer charge policy. OP was performed in each institution either by retropubic or transvesical approach.


Cost analysis


For modelization purposes, we assumed that short-term functional results after each procedure were entirely similar, based on available data from the literature. We performed a minimization cost analysis.


The outcome of each technique was assessed in terms of cost from the institutional perspective. Short-term hospital costs were evaluated for each procedure using the National costs study 2010 from French technical agency of information on hospitals (ATIH; Agence technique de l'information sur l'hospitalisation) database. The National costs study (NCS) defines for different procedures and groups of patients (groupes homogènes de malades [GHM]), variables costs and fixed costs related to the LOS. In our study, for each hospitalization, variables costs were conserved and fixed costs were recalculated by the ratio between observed LOS and mean national LOS. In NCS, only cost related to OP and TURP are considered. For PVP and ThuLEP/HoLEP, we considered variables and fixed costs used for TURP. Cost of equipment and single-use disposal related to innovative techniques were estimated according to the manufacturer charge policy. Using the method of readjusted NCS based on LOS: total cost of hospitalization=&b.Sigma; variables costs+(fixed costs×[LOS"study"/MeanLOS"NCS2010"])+overcost of consumables specific to alternative technique.


Statistical analysis


&khgr; 2 tests were performed to compare groups for non-parametric numerical data. Means from three or more groups were compared using the analysis of variance (ANOVA). A P -value<0.05 was considered statistically significant. Relationships between complications and patient or treatment parameters were first analyzed using univariate regression logistic analysis. Multivariable analyses included covariates with a P -value<0.05 in univariable analysis. All statistical analyses were processed using STATA 11.0.


Results


Institutional characteristics


Table 1 shows practice at the nine institutions involved in this study. Mean number of BPH procedures per year and institution was 223. None of these institutions performed bipolar TURP but seven proposed an alternative to standard treatments (PVP or Holep/Thulep). Overall, 55% and 14% of the patients underwent a monopolar TURP (mTURP) or an OP, respectively. A PVP or an HoLEP/ThuLEP were performed in 22% and 9% of cases, respectively. The use of a surgical alternative in the institution was not associated with a significant decrease in the use of OP (21% and 27% respectively, P =0.23).


Patients' characteristics


A total of 237 patients who underwent surgery for BPH were included in this study. Patients' characteristics are summarized in Table 2 and grouped by technique. Mean age was 71.7±9.8 years. Mean prostate volume was 65.5±39.3mL and 70 patients (30%) had a prostate volume≥80mL. Mean prostate volume was higher in the group of patients who underwent OP as compared to other surgical alternatives (124.3 vs. 65.5mL, respectively). Fifty-six patients (24%) had a urethral catheter at the time of surgery. Sixty-four patients (27.7%) were receiving platelet aggregation inhibitors or oral anticoagulation before the procedure, with a higher ratio in the groups of PVP and HoLEP/ThuLEP (41% and 36% respectively, P =0.001). Groups were comparable regarding age, ASA score and history of urinary retention.


Operative and postoperative characteristics


Perioperative characteristics are described in Table 3. In prostate of less than 80mL, mean operative times per gram of tissue were 1.17, 1.29, and 1.69min per mL of prostate with TURP, PVP and HoLEP/thuLEP respectively (P <0.0001). In prostate≥80mL, mean operative times were 0.60, 0.96, and 1.04min per mL of prostate with OP, PVP, and HolepLEP/ThuLEP (P <0.0001). Mean LOS was 3.5±3 days. In prostate≥80mL, OP was associated with a longer LOS than HoLEP/thuLEP and PVP (7.8, 4.2 and 2.4 respectively, P <0.0001). For men with prostate volumes less than 80mL, mean LOS with alternative surgical treatment were also shorter compared to TURP (P =0.001).


Per and postoperative complications


No major intraoperative complication was reported. Postoperative complications Clavien≥2 occurred in 52 patients (22%). Twenty-six patients (11%) required readmission. Major complications (grade≥3) were reported in 4 patients and included hemorrhagic events with a new procedure in 3 patients and a myocardial infarct in one patient. In multivariable analysis, age (P =0.01), prostate volume (P =0.01) and ASA score (P =0.02) were independent predictors of overall complications while technique (P =0.71) and API (P =0.72) were not.


Cost analysis


Costs from institution perspective according prostate volume and technique are summarized in Table 4. Costs of hospitalization for prostate<80mL were similar between TURP and HoLEP/ThuLEP, but higher with PVP (2168€, 2007€ and 2659€, respectively, P <0.001). For larger prostate, PVP and HoLEP/Thulep were associated with cheaper costs than OP (2501€, 2702€ and 3375€ respectively, P <0.001).


Discussion


PVP and HoLEP are now considered safe and effective surgical alternatives to standard treatments in BPH [3]. These procedures provide several advantages including reduction of bleeding, prevention of TURP syndrome and decrease of hospital stay [6]. One other potential major benefit would be a decrease of healthcare costs. Evaluation of perioperative outcome and cost effectiveness of these techniques compared to standard treatments from multi-institutional study is a critical issue.


Our study shows that PVP and HoLEP are associated with a shorter length of stay than TURP or OP. Data from randomized controlled trials, gathered recently in a meta-analysis by Cornu et al., show that compared to TURP, PVP and HoLEP are associated with a reduction of hospital stay (1.4 and 1.85 days, respectively). Compared to OP, this reduction reaches a mean difference of 4 days with HoLEP [3]. Alivizatos et al. reported a similar reduction of LOS with PVP [7]. In our study, the reduction of LOS is less important than expected. It could be a consequence of patients' co-morbidities or anticoagulation in these groups but we did not find such a difference in our analysis. We believe it reflects the management of alternative surgical treatments in few centers during their initial implementation phase or during the learning curve of some surgeons.


Despite the apparent higher initial costs of the devices and consumables, PVP and HoLEP could be cheaper than TURP and OP due to their benefit regarding LOS. In our study, use of an alternative surgical treatment for prostate larger than 80mL was associated with a higher operative time per gram but shorter LOS. Mean reductions of cost with PVP and HoLEP/ThuLEP were 874€ and 673€, respectively. These results are similar to those observed in previous studies with PVP [8] and HoLEP [9]. Raimbaud et al. evaluated cost effectiveness of PVP and OP in French healthcare system and reported a mean additional cost of 1450 euros for OP [8]. With HoLEP, Salonia et al. demonstrated a 10% reduction of cost hospitalization [9].


Few studies evaluated the cost effectiveness of HoLEP in comparison to TURP but all reported a significant short-term benefit for this surgical alternative [10, 11]. Several studies have already compared costs of PVP and TURP, mostly with the 80W and 120W technologies. Most of these studies concluded to a benefit for PVP [12, 13, 14, 15]. Recently, some authors did not find any significant difference between TURP and PVP [16, 17]. Armstrong et al. previously concluded PVP was even less cost effective than TURP [18]. To our knowledge, only one study compared the last technology XPS 180W but demonstrated a significant benefit for PVP, mostly due to the reduction of LOS [19]. These studies are inhomogeneous regarding quality and methodology. Cost effectiveness of PVP compared to TURP is still questionable. In our study, reduction of LOS was not sufficient to conclude to a significant cost reduction with the surgical alternative when compared to TURP. Cost effectiveness with these new surgical alternatives could probably even be more considerable with their development in an outpatient setting. Indeed, several studies have reported PVP and HoLEP are feasible in an ambulatory setting [20]. Ambulatory surgery requires the development of dedicated unit but is one of national health authorities' priorities [21]. Therefore, Goh and Gonzalez demonstrated that PVP with the greenlight 120W-HPS cost less than TURP ($4266 vs. $5097) but most of the patients were treated on an outpatient basis (defined as discharge home within 23hours of hospitalization) in this study [12]. In high-risk patients, PVP and HoLEP could also demonstrate better results and provide significant cost savings we did not report in our study.


We observed a low rate of major complications. Complication and readmission rates were higher in the groups of surgical alternatives, mostly due to urinary retentions and hemorrhagic events. Urinary retentions were treated by transient recatheterization and patients were discharged one day later. One month after the procedure, only 4 patients were not catheter free. Hemorrhagic events were mostly managed by transient irrigation and only two patients required new procedure. The cost of readmissions was not evaluable in our study but could limit our conclusions concerning cost effectiveness of these procedures. However, in multivariable analysis, the technique was not a predictive factor of complication and the relation we observed could be partly due to a higher rate of patients with anticoagulation or ASA score>2 in these groups.


Our study has several other limitations. First, the study is limited by its retrospective nature and the corresponding cost minimization analysis methods. Due to the lack of specific data in the National cost study and no specific reimbursement for PVP and HoLEP/ThuLEP in France, cost evaluation and profitability is mostly extrapolated from TURP evaluation and comparison essentially based on direct costs associated with the LOS and related French healthcare specificities. Evaluation of the reduction of some consumables such as intraoperative glycine and irrigation fluids, overtime in the operatory room and potential depreciation expense associated with generator acquisition were not considered. We assumed that for PVP one fiber was used per patient and that for LEP, one fiber was used for twenty procedures. A higher use of fiber especially in large prostate could limit our conclusions in this group. Surgeons' skills and experience regarding the procedures were not available. Therefore, the impact of the learning curve and results from few centers during their initial implementation phase of management for some alternative surgical treatments may have biased the results, especially regarding the LOS. No assessment of economic value related to the reduction of LOS in terms of bed availability, early rehabilitation for workers has been either considered. Finally, our study is a short-term cost analysis of the procedures that only relies on the costs incurred during first hospitalization. Integration of the costs related to readmissions may confer further evidence regarding cost effectiveness of alternative surgical treatments. In a midterm follow-up, some authors suggest new alternative treatments could be associated with a higher reinterventions rate, especially in patients with larger prostate volume [22]. Overcost associated with these new procedures could limit our results and cost effectiveness of HoLEP and PVP in large prostate.


However, we believe it is a fair evaluation of the cost-effectiveness of new alternatives for surgical treatments of BPH that compared PVP and HoLEP/thuLEP to TURP and OP in a real world setting in several public and private institutions. This minimization cost analysis is mainly based on a simulation of first hospitalization costs between techniques and differences related to a reduction of LOS. This endpoint is often part of the discussion between the urological community and their institutions. However, long-term longitudinal prospective studies of total costs of these techniques are necessary to clearly conclude on their cost effectiveness.


Conclusion


In this multi-institutional study, use of PVP and HoLEP/ThuLEP significantly decreases LOS. Regarding first hospitalization cost, these procedures could be cost effective alternatives to OP. However, the mean LOS we observed in our study is still not sufficient to consider that these procedures are cheaper or more cost effective than TURP for prostate less than 80mL.


Disclosure of interest


R. Mathieu: support for Congress by AMS; S. Lebdai: no; J.N. Cornu: consultant for companies, Allergan, Astellas, Boston Scientific, Bouchara-Recordati, Coloplast, Medtronic, Mundipharma, Pfizer, SAP, Takeda and investigator for Astellas, Cousin Biotech, Coloplast, GT Urological, Ipsen and Medtronic; A. Benchikh: no; A.R. Azzouzi: no; N.B. Delongchamps: no; O. Dumonceau: no; A. Faix: no; M. Fourmarier: trainer for company EDAP-TMS and Boston scientific; O. Haillot: not stated conflict of interest; B. Lukacs: lecturer for Mylan; V. Misrai: trainer for Boston Scientific; A. de la Taille: no; G. Robert: trainer for company EDAP-TMS and Lumenis; A. Descazeaud: no.




Table 1 - Practice and characteristics of the institutions enrolled in the study.
Institution 
Surgeons for procedures related to BPO 
Practice  Public  Public  Private  Public  Public  Public  Public  Private  Public 
Number of BPO procedures in 2012  179  188  146  113  298  450  235  240  160 
Technique                   
mTURP  76%  45%  41%  60%  45%  85%  22%  23%  90% 
OP  24%  20%  3%  5%  40%  10%  3%  2%  10% 
PVP  30%  5%  75%  75% 
HoLEP/ThuLEP  5%  56%  35%  15% 
Other 



Légende :
mTURP: monopolar transuretral resection of the prostate, PVP: photoselective vaporisation of the prostate; HoLEP: holmium laser enucleation of the prostate; ThuLEP: thullium laser enucleation of the prostate; BPO: benign prostatic obstruction.



Table 2 - Patient characteristics.
  mTURP  Open prostatectomy  HoLep ThuLep  PVP  P value 
n   99  23  64  51   
Mean age, years (SD)  71.1 (±9.6)  72.7 (±6.8)  71 (±11)  71.8 (±9.6)  0.84 
Prostate volume, mL (SD)  49.5 (±25)  124.3 (±43.2)  64.9 (±36.8)  68.8 (±36.6)  <0.0001 
ASA Score          0.09 
1-2 (%)  80%  91%  77%  69%   
3-4 (%)  20%  9%  23%  31%   
Urinary retention (catheter preoperatively) (%)  26%  22%  14%  31%  0.15 
Platelet aggregation inhibitor or anticoagulation (%)  18%  4%  36%  41%  0.001 



Légende :
SD: standard deviation; mRTUP: monopolar RTUP; PVP: photoselective vaporisation of the prostate; HoLEP: holmium laser enucleation of the prostate; ThuLEP: thullium laser enucleation of the prostate.



Table 3 - Perioperative characteristics.
  mTURP  Open prostatectomy  HoLEP/ThuLEP  PVP  P value 
Mean operative time, min (SD)  48.1 (±17.3)  69.9 (±27.5)  82.4 (± 32.7)  72.5 (±40.4)  <0.001 
Mean operative time per gram, min (SD)  1.10 (±0.53)  0.61 (±0.28)  1.51 (± 0.79)  1.17 (±0.56)  <0.001 
Mean length of postoperative stay, days (SD)  3.4 (±2.3)  8 (±3.8)  2.6 (± 2.5)  2.8 (±2.9)  <0.001 
Median length of stay, days   
Prostate<80mL, mean length of postoperative stay, days (SD)  3.4 (±2.5)  1.9 (±1.3)  3 (±3.5)  0.006 
Prostate≥80mL, days, mean length of postoperative stay, days (SD)  7.8 (±3.8)  4.2 (±2.7)  2.4 (±1.4)  <0.001 



Légende :
mRTUP: monopolar RTUP; PVP: photoselective vaporisation of the prostate; HoLEP: holmium laser enucleation of the prostate; ThuLEP: thullium laser enucleation of the prostate.



Table 4 - Cost analysis.
  Prostate volume<80mL 
Prostate volume≥80
  mRTUP  PVP  HoLEP/ThuLEP  P value  OP  PVP  HoLEP/ThuLEP  P value 
Mean cost of hospitalization (€), SD  2168±595.9  2659.2±1397.1  2007.4±546.1  <0.001  3375.2±723.4  2501.4±540.4  2702.2±782.8  <0.001 



Légende :
mRTUP: monopolar RTUP; PVP: photoselective vaporisation of the prostate; HoLEP: holmium laser enucleation of the prostate; ThuLEP: thullium laser enucleation of the prostate; OP: open prostatectomy.


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© 2017 
Publié par Elsevier Masson SAS.