A Propensity Score-Matched Analysis of Perioperative Outcomes of Holmium Laser Enucleation of the Prostate Between Lumenis Pulse 120H and VersaPulse Select 80W

Abstract

Objectives:

Holmium laser enucleation of the prostate (HoLEP) is a valid and safe procedure for the treatment of benign prostatic hyperplasia. This study aimed to examine the perioperative outcomes of HoLEP using a new laser platform, Lumenis Pulse™ 120H, and a previous laser platform, VersaPulse Select 80W.

Methods:

A total of 612 patients who underwent holmium laser enucleation were enrolled, including 188 and 424 patients who underwent enucleation using Lumenis Pulse 120H and VersaPulse Select 80W, respectively. They were matched using propensity scores with preoperative patient characteristics, and the differences between the two groups, including operative time, enucleated specimen, transfusion rate, and complication rate, were examined.

Results:

Propensity score-matched cohort comprised 364 patients with 182 in the Lumenis Pulse 120H group (50.0%) and 182 in the VersaPulse Select 80W group (50.0%). Operative time was significantly shorter with Lumenis Pulse 120H (55.2 ± 34.4 vs 101.4 ± 54.3 minutes, p < 0.001). In contrast, no significant differences were seen in resected specimen weight (43.8 ± 29.8 vs 39.6 ± 22.6 g, p = 0.36), rate of incidental prostate cancer (7.7% vs 10.4%, p = 0.36), transfusion rate (0.6% vs 1.1%, p = 0.56), and perioperative complication rates, including urinary tract infection, hematuria, urinary retention, and capsular perforation (5.0% vs 5.0%, 4.4% vs 2.7%, 0.5% vs 4.4%, 0.5% vs 0%, respectively, p = 0.13).

Conclusions:

Lumenis Pulse 120H improved the operative time significantly, which is regarded as one of the disadvantages of HoLEP.

Introduction

Benign prostatic hyperplasia (BPH) is a progressive disease caused by hyperplasia of the prostatic transition zone in middle-aged and older men. The prevalence of BPH in the age groups of 60 and 70 years in Japan is 6% and 12%, respectively.¹ Lower urinary tract symptoms are first treated by behavioral therapy or pharmacotherapy; however, surgery is indicated for insufficient effectiveness for the treatments or complications including urinary retention, hematuria, bladder stones, renal dysfunction, or urinary tract infection.

Several surgical procedures are available, such as prostate resection, vaporization, and enucleation. Gilling and colleagues first described holmium laser enucleation of the prostate (HoLEP) in 1996.² It is a relatively bloodless procedure that immediately improves urinary symptoms.³ Several technological and procedural developments have been made over the past years to improve the efficacy of the procedure, including comprehensible technical aspects, types of lasers, and new devices.^4

–7 Recently, a new laser platform has been introduced, Lumenis Pulse™ 120H (Lumenis Ltd., Yokneam, Israel).

The platform allows the change of pulse frequency and setting of high energy up to 120 watts, and the surgeon can easily switch between the two laser energy settings with a dual foot pedal. The lower energy setting is used for hemostasis, whereas the higher energy setting is used for enucleation, which allows the surgeon to perform the procedure more efficiently.

This study retrospectively compared the perioperative outcomes of HoLEP between Lumenis Pulse 120H without MOSES technology (dividing the laser wave into two phases: the first phase separates the water by creating a bubble cavity, and the second phase transfers the laser energy to the target) and a previous holmium laser platform, VersaPulse Select 80W (Lumenis Ltd.).

Materials and Methods

Setting

This study was carried out at Jyoban Hospital, which performs ∼1000 urologic surgeries including ∼100 HoLEP procedures per year and is one of the highest volume centers for urologic surgery in Japan.

Participants

A total of 612 patients who underwent HoLEP for BPH between July 2013 and October 2021 at our hospital were included, with 424 and 188 patients who underwent HoLEP using VersaPulse Select 80W and Lumenis Pulse 120H, respectively.

Surgical procedure

An experienced surgeon performed HoLEP with VersaPulse Select 80W between July 2013 and September 2019 and with Lumenis Pulse 120H between September 2019 and October 2021. The energy setting of VersaPulse Select 80W was 80 watts, and that of Lumenis Pulse 120H was 96 watts for enucleation and 30 watts for hemostasis, which could be switched easily with a dual-foot pedal. A 28F continuous cycle flow Storz laser resectoscope was used and laser energy was delivered with a 550 μm fiber. The procedure for HoLEP was performed as described by Kuo et al.⁸

A morcellator system, Lumenis VersaCut™ (Lumenis Ltd.), was used to remove the enucleated prostatic lobes. At the end of the surgery, a 22F three-way catheter was detained and flow irrigation was continued until the following day. On the second postoperative day, the catheter was usually removed.

Data collection

We collected patients' data from medical records, including age, preoperative prostate-specific antigen (PSA) level, presence of previous biopsy history, operative time, resected specimen weight, presence of incidental prostate cancer, perioperative complications, and presence of postoperative transfusion.

The total prostate volume (TPV) and transitional zone volume (TZV) were calculated using the ellipsoid formula (length × width × height × 0.52), which were measured with axial and sagittal slices on T2-weighed imaging (T2WI) of MRI. Moreover, radiologists evaluated whether there were malignant findings. MRI was conducted using a 1.5 T whole-body scanner (MAGNETOM Aera 1.5 T; SIEMENS, Germany) without an endorectal coil and a 32-channel phased-array surface coil.

The obtained images were T2WI in turbo spin echo with fat saturation; diffusion-weighted imaging, with b values of 0, 1500, and 2000; apparent diffusion coefficient maps; and dynamic contrast-enhanced MRI. PSA density and PSA density in the transition zone were calculated by dividing PSA by TPV and TZV, respectively. Hematuria as complications was defined when transurethral coagulation or blood transfusion was performed after HoLEP. Pathologists pathologically evaluated the resected specimens.

Outcomes

The main end point of this study was the differences in the perioperative outcomes between Lumenis Pulse 120H and VersaPulse Select 80W, including operative time, resected specimen weight, rate of incidental prostate cancer, transfusion rate, and complication rates.

Statistical analysis

Three main analyses were performed. First, we performed descriptive statistics regarding clinical variables of the total population and examined patients' characteristics between the VersaPulse Select 80W and Lumenis Pulse 120H groups. Continuous variables are presented as mean and standard deviation (SD) for normally distributed variables, and as median and interquartile range for non-normally distributed variables. Categorical variables are described as percentages. Continuous variables were analyzed using t-test and the Wilcoxon rank-sum test for normally and non-normally distributed data, respectively. Pearson's chi-square test was used for categorical variables.

Second, we performed univariable and multivariable logistic regression analyses to seek variables associated with using Lumenis Pulse 120H in 612 patients. All variables were regarded as covariables in the univariate analysis and the variables in the multivariate analysis were chosen by the backward selection method (p < 0.05).

Finally, we analyzed whether there were differences in perioperative variables between the VersaPulse Select 80W and Lumenis Pulse 120H, with cohorts matched by propensity score. The propensity score was calculated through logistic regression modeling based on all preoperative factors, including presence of previous biopsy rate, age, PSA, TPV, TZV, PSA density, PSA density of the transition zone, and findings on preoperative MRI.⁹ VersaPulse Select 80W and Lumenis Pulse 120H patients were then paired 1:1 on the propensity score with nearest neighbor matching.

A standard caliper size of 0.2 × log (SD of the propensity score) was used, and a standardized difference was estimated before and after matching to evaluate the balance of covariates, with a value <0.1, indicating a balance between the two groups.¹⁰ Following 1:1 propensity score matching, perioperative outcomes, including operative time, resected specimen weight, the rate of incidental prostate cancer, transfusion rate, and complication rates, were examined using the Wilcoxon rank-sum test and Pearson's chi-square test. Statistical significance was set at p < 0.05. Statistical analyses were performed using Stata version 15.1 (Stata Corp. LP, College Station, TX, USA).

This study was approved of the research protocol by an institutional reviewer board and the approval number is JHTF-IRB2021.019.

Results

Table 1 gives patient characteristics before propensity score matching. Among 612 patients, preoperative prostate needle biopsy was performed in 283 patients (46.2%) and there was no prostatic carcinoma before HoLEP. The mean patient age was 72.5 ± 7.1 years with 5.9 ng/mL of median preoperative PSA. The mean TPV and TZV were 65.1 ± 30.1 mL and 52.3 ± 29.6 mL, respectively. The median PSA density and PSA density of the transition zone were 0.10 and 0.13 ng/(mL·mL), respectively. The mean operative time was 91.4 ± 47.9 minutes, mean resected specimen was 44.4 ± 28.0 g, and the rate of incidental prostate cancer was 7.7%.

Table 1.

Patients' Characteristics of Holmium Laser Enucleation of the Prostate in Total Population

	Total	Lumenis Pulse 120H	VersaPulse Select 80W	p
N (%)	612 (100)	188 (30.7)	424 (69.3)
Previous biopsy, n (%)	283 of 612 (46.2)	96 of 188 (51.2)	233 of 424 (55.0)	0.37
Age (years), mean (SD)	72.5 (7.1)	73.6 (7.0)	72.0 (7.1)	0.01
Preoperative PSA (ng/mL), median (IQR)	5.9 (3.2–10.4)	5.7 (2.9–11.4)	5.9 (3.4–9.9)	0.81
Total prostate volume on MRI (mL), mean (SD)	65.1 (30.1)	60.8 (27.9)	67.2 (30.9)	0.02
Transitional zone volume on MRI (mL), mean (SD)	52.3 (29.6)	49.4 (28.4)	53.8 (30.3)	0.10
PSA density [ng/(mL·mL)], median (IQR)	0.10 (0.06–0.17)	0.10 (0.06–0.19)	0.10 (0.06–0.16)	0.50
PSA density of the transition zone [ng/(mL·mL)], median (IQR)	0.13 (0.08–0.22)	0.14 (0.08–0.23)	0.13 (0.08–0.21)	0.50
Findings of the prostate cancer on MRI, n (%)
None	345 of 555 (62.2)	102 of 183 (55.7)	243 of 372 (65.3)	0.03
Peripheral zone	34 of 555 (6.1)	13 of 183 (7.1)	21 of 372 (5.7)
Transition zone	162 of 555 (29.2)	66 of 183 (36.1)	96 of 372 (25.8)
Peripheral and transition zones	14 of 555 (2.5)	2 of 183 (1.1)	12 of 372 (3.2)
Operative time (minutes), mean (SD)	91.4 (47.9)	76.2 (35.6)	98.1 (51.1)	<0.001
Specimen weight (grams), mean (SD)	44.4 (28.0)	43.7 (29.6)	44.7 (27.3)	0.70
Incidental prostate cancer, n (%)	49 (8.0)	14 (7.5)	35 (8.3)	0.73
Transfusion after HoLEP, n (%)	8 (1.3)	1 (0.5)	7 (1.7)	0.26
Complications, n (%)
Urinary tract infection	32 of 612 (5.2)	9 of 188 (4.8)	23 of 424 (5.4)	0.27
Hematuria	22 of 612 (3.6)	8 of 188 (4.3)	14 of 424 (3.3)
Urinary retention	15 of 612 (2.5)	1 of 188 (0.5)	14 of 424 (3.3)
Capsular perforation	6 of 612 (1.0)	1 of 188 (0.5)	5 of 424 (1.2)
Nadir PSA after HoLEP (ng/mL), median (IQR)	0.69 (0.42–1.13)	0.64 (0.42–1.17)	0.69 (0.42–1.17)	0.94
PSA decline (%), mean (SD)	83.4 (14.4)	86.4 (9.4)	83.3 (14.6)	0.54

HoLEP = holmium laser enucleation of the prostate; IQR = interquartile range; PSA = prostate-specific antigen; SD = standard deviation.

Complications included hematuria in 32 (5.2%), urinary tract infection in 22 (3.6%), urinary retention in 15 (2.5%), capsular perforation in 6 (1.0%) patients, respectively. Eight patients (1.3%) received transfusion after HoLEP. Median nadir PSA after HoLEP was 0.69 ng/mL, and the mean percentage of PSA decline was 83.4%. Between Lumenis Pulse 120H and VersaPulse Select 80W, the patients with Lumenis Pulse 120H were older (p = 0.01), had smaller TPV (p = 0.02), more findings of prostate cancer on MRI (p = 0.03), and shorter operative time (p < 0.001).

Table 2 gives univariable and multivariable logistic regression analysis to examine variables associated with using Lumenis Pulse 120H. Age (odds ratio [OR]: 1.04, 95% confidence interval [CI]: 1.01–1.06, p = 0.01), TPV (OR: 0.99, 95% CI: 0.98–0.99, p = 0.02), findings of the prostate cancer in the transition zone on MRI (OR: 1.84, 95% CI: 1.22–2.77, p = 0.004), and operative time (OR: 0.98, 95% CI: 0.98–0.99, p < 0.0001) were independently associated with using Lumenis Pulse 120H.

Table 2.

Logistic Regression Analysis of Perioperative Variables Associated with Using Lumenis Pulse 120H in 612 Patients Undergoing Holmium Laser Enucleation of the Prostate

	Univariate				Multivariate
	OR	95% CI		p	OR	95% CI		p
Age	1.03	1.01	1.06	0.01	1.04	1.01	1.06	0.01
Previous biopsy
No	Reference
Yes	1.17	0.83	1.65	0.37
Preoperative PSA	1.01	0.99	1.02	0.18
Total prostate volume on MRI	0.99	0.98	0.99	0.02	0.99	0.98	0.99	0.02
Transitional zone volume on MRI	0.99	0.98	1.00	0.10
PSA density	1.39	0.54	3.60	0.49
PSA density of the transition zone	0.97	0.54	1.75	0.92
Findings of the prostate cancer on MRI
None	Reference				Reference
Peripheral zone	1.47	0.71	3.06	0.30	1.72	0.80	3.70	0.17
Transition zone	1.63	1.10	2.41	0.01	1.84	1.22	2.77	0.004
Peripheral and transition zones	0.40	0.09	1.81	0.23	0.44	0.09	2.06	0.30
Operative time	0.98	0.98	0.99	<0.001	0.99	0.98	0.99	<0.001
Specimen weight	1.00	0.99	1.01	0.70
Incidental prostate cancer	0.89	0.47	1.70	0.73
Transfusion after HoLEP	0.32	0.04	2.61	0.29
Complications
None	Reference
Urinary tract infection	1.24	0.51	3.02	0.63
Hematuria	0.85	0.39	1.88	0.69
Urinary retention	0.15	0.02	1.19	0.07
Capsular perforation	0.44	0.05	3.76	0.45

CI = confidence interval; OR = odds risk.

Table 3 shows that propensity score-matched cohort comprised 364 patients: 182 in the Lumenis Pulse 120H group (50.0%) and 182 in the VersaPulse Select 80W group (50.0%). Operative time was significantly shorter with Lumenis Pulse 120H (55.2 ± 34.4 vs 101.4 ± 54.3 minutes, p < 0.001), which is a similar result to multivariable logistic regression analysis as already shown.

Table 3.

Perioperative Outcomes between VersaPulse Select 80W and Lumenis Pulse 120H After Propensity Score Matching

	Lumenis Pulse 120H	VersaPulse Select 80W	p
N (%)	182 (50)	182 (50)
Operative time (minutes), mean (SD)	75.2 (34.4)	101.4 (54.3)	<0.001
Specimen weight (grams), mean (SD)	43.8 (29.8)	39.6 (22.6)	0.13
Incidental prostate cancer, n (%)	14 (7.7)	19 (10.4)	0.36
Transfusion after HoLEP, n (%)	1 (0.6)	2 (1.1)	0.56
Complications, n (%)
None	163 of 182 (89.6)	160 of 182 (87.9)	0.13
Urinary tract infection	9 of 182 (5.0)	9 of 182 (5.0)
Hematuria	8 of 182 (4.4)	5 of 182 (2.7)
Urinary retention	1 of 182 (0.5)	8 of 182 (4.4)
Capsular perforation	1 of 182 (0.5)	0 of 182 (0)

In contrast, no significant differences were seen in resected specimen weight (43.8 ± 29.8 vs 39.6 ± 22.6 g, p = 0.36), rate of incidental prostate cancer (7.7% vs 10.4%, p = 0.36), transfusion rate (0.6% vs 1.1%, p = 0.56), and perioperative complication rates, including urinary tract infection, hematuria, urinary retention, and capsular perforation (5.0% vs 5.0%, 4.4% vs 2.7%, 0.5% vs 4.4%, 0.5% vs 0%, respectively, p = 0.13).

Moreover, Supplementary Figures S1 and S2 show learning curves of VersaPulse Select 80W and Lumenis Pulse 120H, respectively. According to these figures, increase of number of patients was not associated with operative time in both groups. This result demonstrated that operative time is probably not associated with surgeon experience but with the laser platform.

Discussion

Both multivariable logistic regression analysis and propensity score-matched cohort showed that HoLEP with Lumenis Pulse 120H significantly reduced the operative time compared with VersaPulse Select 80W. In contrast, the resected specimen weight, incidental cancer detection rate, transfusion rate, and postoperative complication rate were similar between the two groups.

Although HoLEP is considered superior to transurethral resection of the prostate in terms of blood loss, transfusion rate, postoperative catheterization, length of hospital stay, and long-term outcomes, the relatively long operative time is a crucial disadvantage of HoLEP.^11

–14 VersaPulse Select 80W has a single-foot pedal, and the power of energy has to be manually changed when switching between dissection and hemostasis of the tissue. In contrast, Lumenis Pulse 120H has a dual-foot pedal that allows for switching between higher energy for dissection and lower energy for hemostasis, thus resulting in an efficient surgical procedure.¹⁵

In endoscopic surgery, a hemostatic procedure is important to maintain a clear field of operation for a smooth progression of the surgery. It is considered that an easier hemostatic procedure with the Lumenis Pulse 120H significantly shortened the operative time.

The mean resected specimen weight in total was 44.4 (SD: 28.0) g, which was similar to previous study (40.4 [SD: 5.7] g).¹⁶ There was no significant difference in the resected specimen weights between VersaPulse Select 80W and Lumenis Pulse 120H. HoLEP is a surgical procedure that is expected to be effective regardless of the prostate volume, so it is thought that resected specimen weights were similar regardless of the platform.^17
–19 In addition, the rate of incidental prostate cancer in total was 8.0%, which is almost similar to previous reports (5.9%–11.7%).^20

–26 There was also no significant difference between the two groups.

Regarding perioperative complications, both groups experienced similar rates of complications and postoperative blood transfusion. The severity of complications was generally mild, as indicated by a systematic review. The review reported incidences of capsular perforations (2.2%), urinary retention (0.2%), bladder injury (2.4%), ureteral orifice injury (0.4%), hematuria, and clot retention (0.2%) associated with HoLEP. However, all these cases were classified as grades 1 to 2 according to the Clavien–Dindo classification, signifying relatively minor complications.²⁷

Another study found that patients with a history of anticoagulation therapy had a higher incidence of severe complications and blood transfusions when undergoing HoLEP with a 100 W holmium laser generator (VersaPulse).²⁸ Although the blood transfusion rate was similar between VersaPulse Select 80W and Lumenis Pulse 120H in this study, the latter, which offers efficient hemostasis with a dual-foot pedal, may contribute to a decrease in severe complications and blood transfusion rates.

In addition, MOSES technology can be used in the Lumenis Pulse 120H. This technology divides the laser wave into two phases: the first phase separates the water by creating a bubble cavity, and the second phase transfers the laser energy to the target. The incorporation of MOSES technology increases the amount of laser energy transferred to the target. In contrast, conventional holmium lasers cannot control energy consumption because of the formation of vapor bubbles. A review of HoLEP with MOSES technology demonstrated shorter enucleation time, reduced hemostasis time, and decreased laser time.²⁹ The increased energy modulation with pulse optimization for BPH may also contribute to shortening the learning curve of the HoLEP procedure.³⁰

This study had some limitations. First, it was a retrospective cohort study conducted at a single institution. Second, all HoLEPs were performed by one surgeon, with VersaPulse Select 80W in the first stage and Lumenis Pulse 120H in the second stage. Although Supplementary Figures S1 and S2 showed that increase of number of patients may not be associated with operative time in both groups, respectively, it is not completely denied that the improved skill reduced the operative time in the latter period, when Lumenis Pulse 120H was used. Furthermore, in other important clinical assessments, we were unable to demonstrate differences in postoperative pain and urinary continence at both lower and higher energies.

A randomized controlled trial in which multiple surgeons and institutions with different skills perform HoLEP is needed to further validate the clinical differences in both platforms. This was the first study to report that Lumenis Pulse 120H without MOSES technology significantly reduced the operative time. Furthermore, this cohort study had the most cases compared with previous reports, and the study design matched by propensity score from preoperative patient data excluded confounding factors as much as possible. The results obtained using these data were considered reliable.

Conclusions

In conclusion, Lumenis Pulse 120H significantly shortened the operative time, because of higher energy and easy switching between the two laser energy settings for enucleation and hemostasis. This platform may resolve longer operative time than other surgical procedures for BPH, which is considered a disadvantage of HoLEP.

Footnotes

Acknowledgments

I am deeply grateful to all my coauthors.

Authors' Contributions

T.B. contributed to conceptualization, methodology, investigation, data curation, and writing–original draft. K.N. was involved in investigation and data curation. A.O. carried out writing–review and editing. Y.K. carried out conceptualization and methodology. T.O. took charge of resources. H.S. oversaw supervision.

Author Disclosure Statement

The authors declare that they have no conflict of interest.

Funding Information

The authors declare that they received no funding for this study.

Supplementary Material

Supplementary Figure S1

Supplementary Figure S2

Abbreviations Used

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