Adénomectomie voie haute versus vaporisation prostatique au laser GreenLight 180-W XPS : résultats fonctionnels à long terme pour les adénomes > 80 g

25 mars 2018

Auteurs : C. Lanchon, G. Fiard, J.-A. Long, V. Arnoux, D. Carnicelli, Q. Franquet, D. Poncet, E. Bey, J.-B. Lefrancq, S. Grisard, N. Peilleron, N. Terrier, B. Boillot, J.-J. Rambeaud, J.-L. Descotes, C. Thuillier
Référence : Prog Urol, 2018, 3, 28, 180-187




 




Introduction


The increasing development of new laser technologies in benign prostatic obstruction (BPO) has enabled to offer a true alternative to standard treatment, even in large adenomas. Compared to open prostatectomy (OP), they aim to provide similar functional outcome, while reducing morbidity. Holmium laser enucleation (HoLEP) of the prostate has shown in randomized controlled trials to offer comparable immediate and long-term results to both transurethral resection of the prostate (TURP) [1] and OP [2, 3], making it a possible first choice treatment regardless of prostatic volume [4].


Similarly, Greenlight laser photoselective vaporization of the prostate (PVP) has proven to be a safe alternative to TURP in men with moderate prostate volumes, with equivalent long-term results in a recent multicenter prospective study [5]. However, few studies assessed PVP in high prostate volumes, and even fewer compared functional results to OP or analyzed long-term outcome in patients.


This aim of this study was to compare long-term functional outcome of PVP using the latest 180W-XPS Greenlight laser compared to OP in patients with large prostatic adenomas.


Material and method


Data from patients who underwent surgical treatment at our institution for BPO>80g from January 2010 to February 2015 were retrospectively collected. Approval from our institutional ethics committee was obtained for this study (CECIC Rhône-Alpes-Auvergne, Grenoble, IRB 5891).


Data assessment


Patients were divided into 2 groups according to surgical technique (PVP or OP). The following data were collected in both groups: demographics, Charlson score, prostatic volume (PV) on ultrasound, anticoagulant use, preoperative urinary status (IPSS, PSA, urinary retention), surgeon's experience, operative data (operative time, blood loss), perioperative follow-up (transfusion, length of hospital stay and urinary catherization), early (<30 d) and delayed (>30 d) adverse events (AEs), long-term functional outcome.


Early AEs were graded according to Clavien-Dindo classification and divided into two categories: minor (Clavien grade I, II) and major (Clavien grade III, IV). Functional outcome on latest follow-up was assessed using IPSS and IPSS-Quality of Life score (IPSS-QL) and continence with the International Continence Society (ICS) male questionnaire and ICS-Quality of Life (ICS-QL). When long-term IPSS and ICS scores were missing, patients were contacted to calculate their latest scores. PSA level and residual ultrasonographic prostate volume were collected using post mail.


Technique


The type procedure (PVP or OP) was decided individually according to the surgeon's experience, patient's preference, Charlson score and anticoagulant use. OP consisted in a transvesical open enucleation of the prostatic adenoma. PVP was performed using a 180-W GreenLight XPSâ„¢ laser (American Medical Systems®).


Surgeon's were considered experienced for the technique after performing >50 PVP, according to literature [6, 7].


Statistical analysis


Patients were compared according to the type of surgery they received. Continuous variables were reported using mean values with standard deviation (SD) and compared using the independent Mann-Whitney U-test. Categorical variables were reported as counts and proportions (%) and compared using the &khgr;2 test or Fisher exact test as appropriate.


Multiple linear regression was performed to identify independent predictors of long-term IPSS and ICS scores. Variables attaining P ≤0.05 on univariate analysis or considered clinically relevant were included in the multivariate analysis.


Statistical analysis was obtained with SPSS®, version 21.


Results


In the study period, 111 consecutive patients underwent surgical treatment for BPO>80g, including 54 OP and 57 PVP. Baseline characteristics, operative and immediate postoperative data are listed in Table 1 and Table 2.


Demographics and immediate results


Patient's age, Charlson score and preoperative urinary status (IPSS, postvoid residual, urinary retentions) were similar in both groups (Table 1). Mean prostatic volume was superior in the OP group (142 vs 103g, P <0.001) whereas more PVP patients were taking anticoagulants (11 vs 39%, P =0.001).


Operative time was similar between the 2 techniques (P =0.16, Table 2). No patients in the PVP group required conversion to TURP. Mean blood loss after OP was 574 cm3. Compared to OP, PVP was associated with a lower transfusion rate (P =0.02), shorter length of hospital stay (P <0.001) and urinary catheterization (P <0.001), with however a higher rate of unsuccessful voiding trials leading to recatherization (18% vs 4%, P =0.03, RR=4.74) and rehospitalization (19% vs 1%, P =0.004, RR=10.42). Finally, early incontinence was more frequent after PVP, though this difference was not significant.


Early and delayed adverse events


Overall early AEs were similar in both groups (P =0.33, Table 2), with mostly minor complications Clavien I or II. The most frequent early complication in OP patients was macroscopic hematuria with prolonged bladder irrigation whereas it was postoperative urinary retention needing recatherization in the PVP group (Table 3). Early reintervention was necessary for 4 patients in the OP group and 3 in the PVP group. Reasons for reintervention after OP were: 2 for urinary leakages, 1 laparotomy for haemostasis in a patient with Waldenström disease who sufferered cataclysmic hemorrhage and 1 evacuation of Retzius's space hematoma. After PVP, 3 patients required endoscopic clot removal, one associated with complementary prostate resection. Those reinterventions were needed on 3 patients under anticoagulants who left initially hospital and needed readmission at day 5, 8 and 9.


Similarly, overall delayed AEs, occurring after 1 month of surgery, were comparable in both groups (P =0.44), although 3 major delayed complications occurred in PVP patients and none in the OP group. AEs encountered after PVP were: 1 case of hematuria needing endoscopic clot removal, 1 urethral stricture and 1 meatus stenosis leading to iterative dilations.


Finally, 3 patients required re-treatment after PVP (at 1, 6 and 12 months) and none after OP.


Long-term outcome


Long-term functional outcome could be assessed in 42 (78%) patients in the OP group and 43 (75%) in the PVP group, with a mean follow-up of 35 months and 28 months respectively (Table 4).


IPSS and IPSS-QL scores showed improvement compared to baseline in both groups, although preoperative IPSS was available in a limited number of patients. However, results were better after OP than after PVP for IPSS (P <0.001), IPSS-QL (P =0.01), ICS (P =0.002) and ICS-QL (P <0.001).


Long-term PSA and prostate volume on ultrasound were lower in the OP group compared to PVP (1.5 vs 4.3ng/mL, P =0.001 and 30 vs 55 cm3, P =0.001 respectively). The persistence of postvoid residual (PVR) urine was similar in both groups.


Predictors of long-term functional outcome


On multivariate analysis, after adjusting for initial prostatic volume, Charlson score, surgeon's experience, surgical technique and preoperative urinary retention, residual prostatic volume was the only predictor of long-term IPSS (P =0.005, Table 5). Preoperative IPSS was not used in this model due the missing data that could skew the results.


On the contrary, Charlson score was the only predictor of long-term ICS, though it reached statistical limit (P =0.05). Surgical technique, surgeon's experience or residual volume did not appear to predict long-term continence (P =0.86, P =0.97 and P =0.15 respectively).


Discussion


We report here the first study comparing long-term results of the latest 180W-XPS Greenlight system to open prostatectomy in patients needing surgery for BPO with volumes over 80 cm3.


In the era of robotic and minimally invasive surgery, open prostatectomy remains a gold standard treatment of large prostatic adenomas. Laser therapies are increasingly expanding, aiming to reduce morbidity related to open surgery, while obtaining the same functional results. High-level studies have shown HoLEP to achieve both goals [2, 3, 8] which is so far the only laser therapy to be recommended as possible 1st choice alternative according to European guidelines [4]. Growing evidence supports the feasibility and safety of Greenlight PVP in large prostates [9, 10, 11, 12, 13], though most studies were conducted using older systems (80W-KTP and 120W-HPS) and data comparing long-term outcome to traditional OP are very limited.


PVP in large prostates: perioperative outcome


The present study showed PVP in prostates >80 cm3 to be feasible and efficient, leading to a fast recovery for patients. No conversions to TURP were required, and operating time was not extended compared to OP. Alivizatos, who conducted the only randomized trial comparing Greenlight PVP to open prostatectomy, reported similar results though operating time was longer when performing a PVP compared to OP (80 vs 50min respectively) [10]. However, mean prostatic volume, particularly in the OP group, was larger in our cohort (130 cm3 compared to 96 cm3 for Alivizatos) which could explain this difference.


The main benefits of PVP compared to adenomectomy defended by supporters of this technique is the reduction of urinary catheterization time and hospital stay [5, 10, 14], leading to a faster return to health status. Time to catheter removal and discharge after OP [10, 15] and PVP [10, 14], in this study, were comparable to current literature, and supports this premise as catheterization time was divided by 2 and hospital stay by 1.6. Yet, recatheterization and rehospitalization rates were also found to be drastically increased after PVP (RR=4.74 and RR=10.42 respectively), which was rarely reported by other authors, but could constitute a limit patient's should be aware of.


As to the reduction of perioperative morbidity compared to open surgery, transfusion rate after PVP was significantly lower, despite nearly 40% of patients taking anticoagulants, confirming the appeal of this technique in this subgroup of patients. Early and delayed adverse events were acceptable and mostly minor for both techniques according to Clavien-Dindo classification. PVP did not show to reduce overall incidence of AEs compared to OP, as what it gained in transfusion rates, it lost in urinary retentions and recatheterization.


Long-term outcome


Long-term follow-op showed PVP as well as OP to have a satisfying long-lasting outcome for patients with all functional parameters improved from baseline in both groups, although IPSS and ICS scores remained statistically in favor of OP. However, a mean IPSS of 5 at 28 months after PVP is very acceptable. In his recent multicenter study, Hueber [12] also reported a mean IPSS of 5 at 24 months after PVP in prostates over 80g. In our cohort, the most frequent symptoms described by patients were persistent nocturia and a certain degree of urgency. Yet, quality of life scores were excellent for both techniques.


Average prostatic residual volume on ultrasound was larger after PVP compared to OP, and could indicate an incomplete vaporization and a less optimal treatment in these patients. Mean energy density delivered was 4kJ/cm3, which is similar to Hueber (3.8kJ/cm3) [12] and higher than Alivizatos (196kJ for an average volume of 93 cm3) [10]. Misrai assessed the learning curve for PVP, and concluded a mean energy delivered of 5kJ/cm3 was necessary to achieve optimum vaporization [7], suggesting that though satisfactory, our results can further be improved. Moreover, larger postoperative volumes after PVP could explain the higher recatheterizaton rate, and it is possible optimizing the technique would reduce recatheterization as well as improve long-term outcome.


Indeed, on multivariate analysis, postoperative prostatic volume was the only predictor of long-term IPSS. The type of surgery (PVP or OP) did not reveal to predict neither long-term IPSS nor ICS. This suggests that the more thorough the treatment, the better are functional results. On the contrary, incomplete vaporization may lead to less favorable outcome. Hence, the key point to a successful surgery in the long run is to obtain the complete removal of the adenoma, regardless of initial volume or surgical technique. Thus, PVP could achieve similar long-term functional results to open prostatectomy and become a first choice treatment of large adenomas, provided vaporization is complete and prostatic residual volume left to a minimum. Additionally, endoscopic enucleation may be the compromise between the 2 techniques, by guaranteeing a complete removal of the adenoma, thus leading to equivalent long-term results than OP, all-the-while providing the same advantages as PVP in terms of blood loss.


Limitations


The main limitation of our study is its retrospective nonrandomized nature, with therefore 2 populations that were not perfectly comparable. Initial prostatic volume and anticoagulant use were different, suggesting patients with high prostatic volumes were more likely to be offered open surgery, whereas PVP was preferred in case of an elevated risk of bleeding. However, populations were similar in terms of age and Charlson score and preoperative urinary status.


Given the retrospective design of the study, we were not able to report the patients having continued an anticoagulant therapy and those who had interrupted it.


Bladder endoscopic and ultrasonographic characteristics were not assessed since no endoscopic evaluation was performed before open prostatectomy and data concerning endoscopic constatations on operative reports were rarely available. This is a bias since it is known that this characteristics impact deeply functional results. Furthermore, preoperative IPSS was often missing, making it impossible to evaluate it a potential predictor of long-term IPSS.


Finally, our mean energy delivered of 4kJ when using PVP is a little below optimum value and it is possible that an increase to 5kJ would improve functional outcome for patients.


In the Goliath study, recovery data signifcantly favoured GreenLight System over TURP, thus greatly supporting GreenLight XPS for BPH treatment during short-term stay. Even though our study was not designed as a cost analysis, cost advantage may be still greater when compared to OP. Estimated on a day-case basis, laser therapy was signifcantly more cost-effective than TURP with a 25% reduction in procedural cost, lower indirect costs, and lower financial burden based on efficacy and adverse-event outcomes. We think that on selected patients, day case management is possible even for large prostates and is able to offset the probe's cost.


Conclusion


PVP of large prostatic adenomas is safe and effective with satisfying long-lasting functional results, although OP remained superior in terms of long-term IPSS and ICS scores. However, the main predictor of postoperative IPSS is the remaining prostatic volume, which surgeons should be aware of when performing a PVP in order to achieve a complete vaporization of the adenoma. Furthermore PVP is an attractive alternative in patients taking anticoagulants, enabling to offer a safe option regardless of prostatic volume. Endoscopic enucleation may the compromise between both techniques.


Disclosure of interest


The authors declare that they have no competing interest.




Table 1 - Baseline characteristics of treated patients.
  OP
n =54 
PVP
n =57 
P -value 
Age (yr)
Mean (±SD) 
74 (±9)  77 (±9)  0.09 
Charlson score
Mean (±SD) 
4 (±1.7)  5 (± 2)  0.15 
Prostatic volume (cm3)
Mean (±SD) 
142 (±58)  103 (±25)  <0.001* 
Preoperative anticoagulant use
n (%) 
6 (11)  22 (39)  0.001* 
Preoperative aspirin use
n (%) 
8 (15)  16 (28)  0.11 
Preoperative urinary retention
n (%) 
31 (57)  39 (68)  0.24 
Preoperative PVR
n (%) 
19 (42)  17 (50)  0.50 
Preoperative IPSS
Mean (±SD) 
20 (±7)  18 (±6)  0.59 
Preoperative IPSS-QL
Mean (±SD) 
4 (±1)  4 (±1)  0.82 
Preoperative PSA
Mean (±SD) 
10.1 (±7.9)  7.3 (±5.4)  0.09 



Légende :
IPSS: International prostate symptom score; IPSS-QL: IPSS-quality of life score; PSA: prostate specific antigen; PVR: postvoid residual.

[*] 
Statistically significant.


Table 2 - Operative and perioperative parameters.
  OP
n =54 
PVP
n =57 
P -value 
Operative time (OT, min)
Mean (±SD)  
69 (±24)  73 (±18)  0.16 
Lasing time (LT, min)
Mean (±SD)  
50 (±14.8) 
LT/OT ratio (%)
Mean (±SD)  
60 (±26) 
Total energy delivered (kJ)
Mean (±SD)  
383 (±150) 
Energy per prostate volume (kJ/cm 3 )
Mean  
4 (±1) 
Transfusion rate
n (%)  
6 (11)  2 (3)  0.02* 
No of PRBCs
Mean (±SD)  
2 (±2)  2 (±0)  0.02* 
Length of catheterization (d)
Mean (±SD)  
6 (±2)  3 (±4)  <0.001* 
Recatherization
n (%)  
2 (4)  10 (18)  0.03* 
Urinary incontinence
n (%)  
6 (11)  14 (25)  0.06 
Length of hospital stay (d)
Mean (±SD)  
8 (±2)  5 (±5)  <0.001* 
Rehospitalisation
n (%)  
1 (2)  11 (19)  0.004* 
Early AEs, n (%)        
Minor (Clavien I, II)  13 (24)  21 (37)  0.16 
Major (Clavien III, IV)  4 (7)  3 (5)  0.71 
Total  17 (32)  24 (42)  0.33 
Delayed AEs, n (%)        
Minor  7 (13)  8 (14)  1.00 
Major  0 (0)  3 (5)  0.24 
Total  7 (13)  11 (19)  0.44 



Légende :
LT: lasing time; OT: operative time; PRBCs: packed red blood cells.

[*] 
Statistically significant.


Table 3 - Early and delayed adverse events.
Adverse events  OP
(n =54) 
PVP
(n =57) 
P -value 
Early AEs (< 1 month after surgery)        
Clavien-Dindo grade I - II, n (%)       
Isolated fever  1 (2)  0 (0)  0.49 
Bleeding  3 (7)  0 (0)  0.11 
Urinary clot removal  5 (9)  7 (12)  0.76 
Transfusion  12 (23)  5 (9)  0.04* 
Recatheterization  2 (4)  10 (18)  0.03* 
Urinary tract infection  1 (2)  5 (9)  0.21 
Other  1 (2)  1 (2)  1.00 
Total  24 (44)  28 (49)   
Clavien-Dindo grade III - IV, n (%)       
Retzius's space hematoma  1 (2)  0 (0)  0.49 
Reintervention for urinary leakage  2 (4)  0 (0)  0.38 
Reintervention for bleeding  1 (2)  3 (5)  0.61 
Total  4 (7)  3 (5)  0.43 
Delayed AEs (> 1 month after surgery)        
Minor       
Hematuria  2 (4)  2 (4)  1.00 
Urinary tract infection  2 (4)  3 (4)  1.00 
Epididymitis  1 (2)  0 (0)  0.49 
Urinary retention  1 (2)  3 (5)  0.61 
Other  1 (2)  0 (0)  0.49 
Total  7 (13)  8 (14)  1.00 
Major       
Meatus stenosis  0 (0)  1 (2)  0.49 
Urethral stricture  0 (0)  1 (2)  0.49 
Endoscopic clot removal  0 (0)  1 (2)  0.49 
Total  0 (0)  3 (5)  0.24 



[*] 
Statistically significant.


Table 4 - Long-term functional results.
  OP
n =42 
PVP
n =43 
P- value 
Follow-up (month) - mean (±SD)  35 (±19)  28 (±12) 
IPSS - mean (±SD)  1 (±2)  5 (±5)  <0.001* 
IPSS-QL - mean (±SD)  0 (±1)  1 (±1)  0.01* 
ICS - mean (±SD)  0 (±1)  3 (±6)  0.002* 
ICS-QL - mean (±SD)  0 (±0)  1 (±2)  <0.001* 
No of protections - mean (±SD)  0 (±0)  1 (±1)  0.0004* 
Postoperative PVR - n (%)  3 (9)  8 (20)  0.20 
PSA (ng/mL) - mean (±SD)  1.5 (±1.0)  4.3 (±2.8)  0.001* 
PSA reduction (%) - mean (±SD)  82 (±12)  45 (±36)  0.001* 
PV (cm3) - mean (±SD)  30 (±8)  55 (±25)  0.001* 
PV reduction (%) - mean (±SD)  74 (±9)  47 (±20)  0.001* 



Légende :
ICS: International continence society male questionnaire; ICS-QL: ICS-quality of life score; IPSS: International prostate symptom score; IPSS-QL: IPSS-quality of life score; PV: prostatic volume; PVR: postvoid residual.

[*] 
Statistically significant.


Table 5 - Predictors of long-term IPSS and ICS scores on multivariate analysis.
  Variable  β  IC 95%  P -value 
IPSS  Initial prostatic volume  −0.27  −0.09; 0.01  0.14 
Charlson score  0.17  −0.34; 0.98  0.32 
Surgeon's experience  −0.14  −4.50; 1.94  0.41 
Surgical technique  0.30  −1.20; 6.60  0.16 
Preoperative urinary retention  −0.62  −10.55; 1.64  0.10 
Prostatic residual volume  0.63  0.03; 0.12  0.005* 
ICS  Initial prostatic volume  −0.06  −0.07; 0.06  0.77 
Charlson score  0.41  −0.004; 1.75  0.05* 
Surgeon's experience  0.17  −2.50; 6.09  0.39 
Surgical technique  0.22  −2.99; 7.42  0.38 
Preoperative urinary retention  −0.06  −6.57; 5.23  0.83 
Prostatic residual volume  0.32  −0.02; 0.11  0.20 



[*] 
Statistically significant.


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