Photoselective vaporization of the prostate with the 180-W XPS-Greenlight laser: Five-year experience of safety, efficiency, and functional outcomes.
Benign prostatic hyperplasia (BPH) is a common condition diagnosed in men with increasing incidence after the age of 50. (1,2) Clinically, it manifests itself by progressive development of lower urinary tract symptoms (LUTS) that include voiding and storage disturbances. (1,2) The severity of BPH and the patient s degree of bothersome can be assessed by self-administered questionnaires as the I-PSS score. (1) Medical treatment should be offered to patients with moderate to severe symptoms (IPSS 8-35). According to the American and other international guidelines, surgery should be suggested as an option to patients having one or more of the following: urinary symptoms refractory to maximal medical therapy, gross hematuria, recurrent infections, bladder stones, or deterioration of kidney lunction. (1-3) Transurethral resection of the prostate (TURP) remains the gold standard treatment for LUTS secondary to BPH. (1) However, this intervention is associated with safety issues, particularly in patients taking anticoagulation therapy and those with larger prostates (> 80 cc). (4,5)
Over the past decades, Greenlight (GL) 532nm-laser photo selective vaporization of the prostate (PVP) has gained widespread acceptance as a safe and effective alternative to TURP. (3,6) This technology is based on a 532 nm length laser that vaporizes the highly vascularised transitional prostatic zone by selectively heating the hemoglobin. (7,8) In the year 2000, the first laser 80W KTP laser was commercialized. It was succeeded in 2006 by the 120W HPS system and most recently, in 2011, by the 180W Light XPS (GL-XPS). Studies have demonstrated that PVP was as safe and efficient as TURP with significant shorter catheterization and hospitalization times. (6,9,10) However, durability outcomes have been questioned for the initial 80W and 120W generation systems. (9) Despite the 180W XPS improved efficiency and short-term benefits, long-term data assessing BPH treatment durability is lacking. As such, we report the efficacy and safety of the 180W XPS system over a five-year experience and followup.
In this single institutional retrospective study, we prospectively collected data for 370 men who underwent 180W XPS GL (Boston Scientific, Boston, MA, USA) for BPH between 2011 and 2016. Patients with prostate cancer (n = 16) and those treated with the HPS GL (n = 38) were excluded from the analyses. Indications for treatment were based on the AUA BPH clinical guidelines. (1) Institutional-review board approval was obtained for the study.
All men were treated with the 180W XPS GL as previously reported. The surgeries were performed by a single experienced surgeon at our institution. The approach and technical procedure about the GL 180W XPS surgery is well described in Zorn et al. study published in 2011. (11,12)
All patients had PSA, IPSS, QoL, PVR, Qmax and transrectal ultrasound prostate volume assessment before surgery. Men were followed up at 3, 6, 12, 24, 36, 48 and 60 months. The outcomes of the patients were documented at each visit. The results were compared to preoperative values. Patients identify as dropout we scheduled for a 5 year visit. Complications were also prospectively described in this study. They included OAB symptoms, stress urinary incontinence, dysuria, urinary tract infection, urinary retention, hematuria, urethral strictures, and erectile dysfunction (EHS & SHIM scores). These complications were categorized according to the Clavien-Dindo classification. (13)
Means and standard deviations were reported for continuous variables, and proportions were used for nominal variables. Categories were compared using the Chi-square test and Fisher exact test for continuous variables. A p-value < 0.05 was considered as statistically significant. All analyses were performed using the SPSS software.
After exclusion, the study included 370 men who underwent PVP using the GL 180W XPS. Patients were followed up for a period of 5 years (mean 59.4 months; CI [55.4 -63.5]; median: 56.3 months). However, only 66 patients (out of 370) had a complete 5-year follow up. The functional outcomes are comparable between the 66 patients and all other patients during the follow-up period (tables 3 and 4). The mean age of the patients was 68 years. Moreover, the mean prostate was 78.8 cc [70.9 - 78.7]. Mean operative time of the surgical procedures was 62.7 minutes [59.6 - 65.7] with a mean total energy expenditure of 270.2 kJ [255.2 - 285.2] per surgery. Thus, the average energy density utilization was 3.7 kJ/cc [3.6 - 3.9] in the entire cohort.
To note, 7 (1.9%) of the patients were on anticoagulation therapy at the time of surgery knowing that 135 men (36.5%) stopped anticoagulation days before surgery. Patients' perioperative characteristics are summarized in tables 1 and 2.
Functional outcomes were reported preoperatively and at 3, 6, 12, 24, 36, 48 and 60 months (tables 3 and 4). Retrospectively, at pre-op, the mean values for the IPSS, QOL, Qmax, and PVR were 26.2, 4.7, 5.5 mL/s, and 345 mL. After 5 years, the values recorded were 6.5, 1, 18.4 mL/s and 53.7 mL respectively. All functional outcomes significantly improved compared to baseline and appear to be maintained over the follow up period. With respect to the PSA, the average pre-operative value was 6.2 ng/mL compared to 2.5 ng/mL after 5 years (Figure 1).
Clavien-Dindo categorized adverse events are listed in table 5. At 3 months, 63 (18.8%) patients had treatment for irritative voiding symptoms with possible pre-existing OAB. This incidence dropped to 16 (8,46%) at 1 year and 0 at 5 years suggesting improvement of irritative voiding parameters after resolution of BOO post operatively. On the other hand, 5 (1.5%) patients had signs of bladder underactivity at 3 months. With respect to dysuria, 14 (4.7%) patients complained of burning sensation 3 months after the surgery compared to 0 patients after 4 years. 8 (2.4%) patients had urinary infections within 3 months postoperatively requiring antibiotic treatment. Concerning bladder neck contracture, cystoscopy confirmed its diagnosis in 2 patients within 6 months, and in 5 (2.6%) patients at 1 year. Only 2 men (0.5%) were reported to have clinically worsening erectile dysfunction at 6 months. Most important with respect to treatment durability, only 4 (1.1%) men required BPH retreatment: 1 at 1 year, 1 at 2 years and 2 at 4 years. Mean procedure prostate volume and kJ/ cc treatment were 87.3 cc and 3.9 kJ/cc in these patients.
In 2011, Bachmann et al. were the first to report promising results on the efficiency and safety of the 180W XPS GL treatment for lower urinary tract symptoms. (14) As its predecessors, the 180W is a 532-nm lithium triporate laser, but it is equipped with a MoXy liquid-cooled fiber., (7,15) This innovative technology was created to enhance the efficiency, durability and safety of GL prostatectomy for patients with BPH. This technique can be offered in the long run to patients with large prostates rather than undergoing open prostatectomy. (15) Indeed, the 180-W GL safety has been upgraded by an infra-based feedback mechanism at the fiber-tip along with a new-pulsed coagulation device. Such features would allow the rapid control of bleeding intra-operatively. Furthermore, the increased output power allows improvement in the rate of vaporization and therefore a faster operative time. (7,16) Since its introduction to the urological armamentarium, several studies reported its superiority to monopolar TURP with shorter hospitalization, shorter catheterization time and faster time to clinical stability. (16,17)
More recent studies have demonstrated excellent outcome of 180W XPS GL PVP over a period of 2 years. (6) The current study is unique as it is the first study to the best of our knowledge to report 5-year durability outcomes. To note, only 66 patients (out of 370) had a complete 5-year follow up. In addition, it is important to mention that the patients treated had an average prostate size of 78.8 cc measured by TRUS preoperatively, which is significantly larger than in the Goliath trial (48.6 cc). All functional outcomes demonstrated and sustained significant improvement even after a period of 5 years. Similar
As mentioned previously, the Goliath study is the only prospective randomized clinical trial comparing 180W XPS and TURP with an exclusion of any patient in urinary retention. (6) At 2 years, they reported an IPSS score of 6.9, which suggests a drop of 14.3 points (67.5%) form baseline (21.2 points). Moreover, in our study preoperatively, the IPSS was 26.2 points with 46% of patients in urinary retention at the time of surgery. After initial rapid decline in IPSS postoperatively at 3 months (mean 7.7 points), future decline to nadir was observed at 3 years (mean IPSS of 5.1 points). This suggested the immediate relief of obstructive urinary symptoms with a delay recovery in bladder storage symptoms. At 5-year follow-up, the IPSS was 6.5, meaning a 75.2% (19.7 points) drop from baseline. Similarly, the reported QoL score was 1. This significant improvement was similar to the 71.1% drop (1.3 from 4.6) observed at 2 years in the GOLIATH study. (6)
With regards to urodynamic parameters, we observed that Qmax reached its maximal value at 1 year with an increase of 14.4 mL/s from 5.5 mL/s at baseline. At 5 years, the Qmax was 18.4 mL/s. Such results are comparable to Altay et al. study, which included 68 patients only with prostates larger than 80 mL, demonstrating a significant improvement at 1 year with a Qmax of 16 mL/s compared to 7.6 mL/s pre-op. Furthermore, Bachmann et al. reported an increase of 12.6 mL/s at 6 months with a preoperative Qmax of 8.4 mL/s. (14) When treated with TURP, the mean Qmax before the operation was 7.1 mL/s and reached 20.0 mL/s after 5 years. (18) This increase of 12.9 mL/s is comparable with the increase after 5 years of surgery with the 180W XPS. PVR is another parameter used to evaluate functional outcome following BPO surgery. Several components play a role in determining the value of the post void residue. Such components include the duration of BOO and its effect on the detrusor muscle. Other factors like prostatic regrowth, urethral strictures, the usage of anticholinergic medications and age-related detrusor contractibility influence bladder emptying. (1) In our study, the average PVR at 5 years was 53.7 mL compared to 345 mL preoperatively. The PVR nadir was reached at 4 years with a value of 32.8 mL (90.5% drop). The review of the literature made by Castellan et al. revealed that after a 3 and 6 month follow up the PVR decreased significantly. (17) Tasci and al showed that the PVR, after TURP, improved by 116.6 mL after 5 years. The mean PVR was 142 at baseline and 25.4 mL at 5 years. (18)
Moreover, PSA reduction has been established in the Holmium laser enucleation of the prostate (HoLEP) literature as a surrogate marker for BPH adenoma removal and thus is another useful parameter to assess the success and durability of BPO surgery. (19) In the present study, with 3.7 kJ/cc the PSA decreased from 6.2 ng/mL to 2.5 ng/mL after 5 years with a 59.3% drop. In comparison to the Goliath study, the PSA drop for the TURP group was around 57.7% from a preoperative value of 2.6 ng/mL. (6) BPH surgical retreatments was only 1% in our observed cohort.
As per international BPH guidelines, TURP is still the gold standard for surgical management of LUTS secondary to BPH for patients with prostate size < 80 cc, because of its efficacy and global access. Unfortunately, bleeding and long term durability are the Achilles heel to this procedure. Reich et al. evaluated the outcomes of 10,654 men who underwent TURP and demonstrated that morbidity and mortality increases with the increase in preoperative prostatic size. (5,20)
Moreover, Holmium laser enucleation of the prostate (HoLEP) is another well-established laser minimally invasive endo-surgical option for the management of BPH. HoLEP has been demonstrated as a size independent procedure with incredible long-term durable outcomes. (21) Table 5 compares outcomes for GL 80W, 120W, T URP and HoLEP. (18,22,23,24)
Complications are part of any surgical procedure. The most commonly reported complication was the clinical symptoms of OAB, which was observed in 63 patients (18.8%) 3 months after the surgery. 1 year post-op, only 16 patients were still medically treated for OAB suggesting BOO relief improvement in detrusor hyperactivity. After 5 years of follow-up, there were no complications reported. Bladder neck contracture has been observed in 1 - 12% after PVP or TURP and as high as 0.5 - 17.5% after radical prostatectomies. (25) In our study, a total of 7 men (1.9%) developed BNC during follow-up. Mean prostatic volume in such patients was 72 cc. Most were diagnosed within 6 months. The other 5 patients were diagnosed 1 year post-operatively. During our 5-year experience, 4 (1.1%) patients needed bladder neck resection; 1 after one year, 1 at two years, and 2 at four years. Comparatively, the rate of retreatment after TURP was estimated to be 7.6%. (6) In the literature, many studies didn't experience BNC, but they only had data collected for 30 days post-op. (26) Therefore, BNC is probably a late surgical complication.
Despite its merits, our study has certain limitations that need to be mentioned. Results are obtained from a retrospective analysis of a prospectively maintained database of single surgeon in a single institution. This is reflected in the loss at follow up at 4 and 5 years with only 42 (88.7% drop) and 66 (82.2%), respectively. However, the percentage of the patients participating in the study out of the number of eligible patients is 93% and 96% at 4 and 5 years, respectively. Despite these limitations we believe that our results indicate that 180W XPS GL PVP in experienced hands delivering volume appropriate energy ([greater than or equal to] 3 - 4 kJ/cc) is a safe, efficient, and durable procedure. (27) This article can be the backbone for counseling men more accurately and precisely before choosing the surgical procedure for small to medium size BPH.
Greenlight PVP can be considered a safe and durable procedure for patients with BPH needing surgical treatment. This study has shown the effectiveness of this procedure that can be maintained for a period of at least 5 years.
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Figures and Tables
Khaled Ajib, MD (1); Mila Mansour (1); Marc Zanaty, MD (1); Mansour Alnazari, MD (1); Pierre-Alain Hueber, MD (1); Malek Meskawi, MD (1); Roger Valdivieso, MD (1); Come Tholomier (1,2); Benjamin Pradere, MD (3); Vincent Misrai, MD (4); Dean Elterman, MD, MSc, FRCSC (5); Kevin C. Zorn, MD, FRCSC
(1) Section of Urology, Department of Surgery, Centre Hospitalier de l'Universite de Montreal, Montreal, QC, Canada; (2) Department of Urology, McGill University, Montreal, QC, Canada; (3) Department of Urology, Centre Hospitalier Universitaire, Tours, France; (4) Department of Urology, Clinique Pasteur, Toulouse, France; (5) Division of Urology, University of Toronto, Toronto, ON, Canada
Cite as: Can Urol Assoc J 2018 March 19; Epub ahead of print. http://dx.doi.org/10.5489/cuaj.4895
Caption: Fig. 1. Functional outcomes. IPSS: International Prostate Symptom Score; PSA: prostate-specific antigen; PVR: post-void residual; Qmax: maximum flow rate; QoL: quality of life.
Table 1. Baseline characteristics Number of Mean Confidence interval patients Age (years) 370 67.8 66.9-68.7 BMI (kg/[m.sup.2]) 370 26.8 26.4-27.2 Prostate volume 370 78.8 70.9-78.7 (cc) Median lobe 138 (37.3%) (preop ultrasound or cystoscopy) Duration on [alpha]- 370 2.01 1.8-2.2 adrenergic blockers (years) Duration on 241 1.8 1.5-2.1 5-alpha reductase inhibitors (years) Retention with 170 (45.9%) urethral catheter at time of surgery Anticoagulation 135 (36.5%) stopped before Aspirin: 94 surgery and clopidogrel: 5 resumed Aspirin + immediately clopidogrel: 12 thereafter Coumadin switched to low molecular weight heparin: 15 Dabigatran etexilate: 6 Aspirin + dabigatran etexilate: 3 Continued 7 (1.9%) anticoagulation Aspirin: 3 at time of Aspirin + surgery clopidogrel: 3 Coumadin switched to low molecular weight heparin: 1 Table 2. Operative parameters Number of Mean Confidence patients interval Duration of 370 62.7 59.6-65.7 surgery (min) Total energy 370 270.2 255.2-285.2 used (kJ) Energy per g 370 3.7 3.6-3.9 (kJ/cc) Number of 370 1.12 1.09-1.16 fibers used Pathological 370 3.9 3.3-4.5 specimen weight of retrieved tissue removed (g) Hospital stay 370 0.7 0.5-0.8 (days) Foley 370 1.1 1.0-1.2 catherization (days) Conversion to 10 TURP (2.7%) TURP: transurethral resection of the prostate. Table 3. Outcomes of 180 XPS Greenlight Outcomes Preoperative Months 3 6 12 24 PSA 6.2 NA 2.3 2.0 2.6 (ng/mL) 4.5-8.1 1.9-2.6 1.8-2.3 2.3-2.9 IPSS 26.2 7.7 6.1 5.8 5.4 25.6-26.8 7.2-8.2 5.7-6.5 5.3-6.3 4.9-5.9 QoL 4.7 1.3 1.02 0.9 0.9 4.6-4.8 1.2-1.4 0.9-1.1 0.8-1.1 0.9-1.5 Qmax 5.5 19.9 20.2 19.9 19.8 (mL/s) 5.3-5.9 19.5-20.5 19.5-20.6 19.2-20.4 19.1-20.5 PVR (mL) 345 45.1 38.9 44.3 44.2 320-370 36.2-54.5 31.1-46.8 33.5-55.1 29.9-55.5 Outcomes Months 36 48 60 p PSA 2.4 2.8 2.5 <0.001 (ng/mL) 1.7-3.1 1.4-4.0 0.3-4.0 IPSS 5.1 6.2 6.5 <0.001 4.54-5.70 5.0-7.4 4.0-8.9 QoL 0.8 0.9 1.0 <0.001 0.6-0.9 0.7-1.2 0.9-1.48 Qmax 19.5 19.3 18.4 <0.001 (mL/s) 17.8-19.8 17.7-20.8 16.5-20.4 PVR (mL) 40.4 32.8 53.7 21.2-59.7 12.6-52.9 36.1-71.4 <0.001 IPSS: International Prostate Symptom Score; PSA: prostate-specific antigen; PVR: post-void residual; Qmax: maximum flow rate; QoL: quality of life. Table 4. Outcomes of 180 XPS Greenlight of the 66 patients with complete 5-year followup Outcomes Preoperative Months 3 6 12 24 PSA 11.9 NA 3.2 2.5 2.7 (ng/mL) 8.4-15.0 1.5-4.9 1.4-3.7 1.5-3.9 IPSS 25.3 7.9 6.0 5.1 4.9 23.5-26.8 6.8-9.1 5.1-6.9 4.3-7.8 4.3-5.5 QoL 4.5 1.3 0.9 0.9 0.8 4.2-4.8 1.0-1.6 0.7-1.2 0.7-1.2 0.6-1.0 Qmax 4.5 20.3 20.5 20.3 20.8 (mL/s) 4.2-4.8 19.4-21.2 19.4-21.6 19.0-21.6 19.8-21.8 PVR (mL) 293.1 20.9 26.6 23.8 23.2 229.9-356.2 11.2-30.6 12.9-20.3 12.6-34.9 10.6-35.7 Outcomes Months 36 48 60 p PSA 2.8 2.7 2.5 <0.001 (ng/mL) 1.7-3.8 1.6-3.8 0.3-4.0 IPSS 4.9 5.4 6.5 <0.001 4.3-5.6 4.5-6.4 4.0-8.9 QoL 0.8 0.9 1.0 <0.001 0.6-1.0 0.7-1.1 0.9-1.48 Qmax 18.8 16.8 18.4 <0.001 (mL/s) 17.7-19.9 15.6-18.1 16.5-20.4 PVR (mL) 43.7 55.5 53.7 15.1-72.3 31.0-79.9 36.1-71.4 <0.001 IPSS: International Prostate Symptom Score; PSA: prostate-specific antigen; PVR: post-void residual; Qmax: maximum flow rate; QoL: quality of life. Table 5. Complications of 180W XPS Greenlight Months 3 6 12 Number of patients 336 221 189 Number of eligible 343 246 200 patients Clavien-Dindo grade Minor: I/II OAB 63 29 16 (%) (18.8) (13.1) (8.46) SUI 17 4 6 (%) (5.1) (1.8) (3.17) Dysuria 14 4 3 (%) (4.6) (1.8) (1.6) UTI 8 3 2 (%) (2.4) (1.4) (1.1) Bladder 5 3 1 underactivity/ (1.5) (1.4) (0.5) retention (%) Hematuria 6 2 1 (%) (1.8) (0.9) 0.5) Major: IIIa/IIIb Urethral stricture 0 1 2 (%) (0.5) (1.1) Bladder neck 1 1 5 contracture (0.3) (0.5) (2.6) (%) BPH recurrence 0 0 1 requiring repeat (0.5) BPO surgery (%) Months 24 36 48 60 144 89 42 66 144 89 45 69 Clavien-Dindo grade Minor: I/II 10 7 4 0 (6.9) (7.9) (9.5) 2 2 2 0 (1.4) (2.2) (4.8) 1 4 0 0 (0.7) (4.5) 0 0 0 0 4 1 0 0 (2.8) (1.1) 4 2 0 0 (2.8) (2.2) Major: IIIa/IIIb 0 0 0 0 0 0 0 0 1 0 2 0 (0.7) (4.8) BPH: bengign prostatic hyperplasia; BPO: benign prostatic obstruction; OAB: overactive bladder; SUI: stress urinay incontinence; UTI: urinary tract infection. Table 6. Literature review of other modalities Parameter 80W 120W (Guo et al) (Cho et al) Number 120 85 of patients Preoperative 60 Preoperative 36 months months Mean 52.3 NA 50 NA prostatic 33-72.6 33-67 volume (cc) Energy 225.8 NA 92.35 NA delivery 129.6-332 16.5-168.2 (kJ/cc) OR time 72.7 NA 60.3 NA (min) 49.9-95.5 28.7-92.5 PSA 3.5 2.2 4 NA (ng/ml) 0.1-7.1 0.3-4.1 0.8-7.2 IPSS 19.4 6.6 13.1-25.7 4.7-8.5 21.7 13.4 13.8-29.6 11-15.8 QoL 3.7 1.3 2.3 2-5.4 0-3.1 4.2 1.6-3 3.0-5.4 13.9 Qmax 8.3 6.8 12-14 (ml/s) 2.3-14.3 2.6-11 8.7 5.6-11.8 35.3 PVR (ml) 119.5 34.5 15-55 35.7-203.3 0-114.5 93.5 BPH 10.2 2.3-184.7 NA retreatment (%) Mean 12 36 followup (months) Parameter TURP HoLEP (Tasci et al) (Elmansy et al) Number 3589 949 of patients Preoperative 120 Preoperative 120 months months Mean 62.4 NA 81 NA prostatic 50.4-74.4 volume (cc) Energy NA NA 96.0 NA delivery (kJ/cc) OR time 42 NA NA NA (min) 30.3-53.3 PSA 3.9 2.3 4.3 0.69 (ng/ml) 3-4.8 0.4-4.2 IPSS 26 6.9 19 3.6 23-29 2.8- 11 0-35 0-12 QoL 4 1.8 3.8 0.7 3-5 1.3-2.3 0-6 0-3 Qmax 20 (ml/s) 7.1 11.5-28.5 8 26.9 4.7-9.5 1.3-20 6.6-44.5 PVR (ml) 25.4 142 17.3-33.5 311 20.7 BPH 131-153 102-500 0-654 retreatment 4.4 (%) 0.7 Mean followup 42 (*) 62 (months) BPH: bengign prostatic hyperplasia; IPSS: International Prostate Symptom Score; OR: operating room; PSA: prostate-specific antigen; PVR: post-void residual; Qmax: maximum flow rate; QoL: quality of life.
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|Title Annotation:||Original Research|
|Author:||Ajib, Khaled; Mansour, Mila; Zanaty, Marc; Alnazari, Mansour; Hueber, Pierre-Alain; Meskawi, Malek;|
|Publication:||Canadian Urological Association Journal (CUAJ)|
|Date:||Jul 1, 2018|
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