Evaluation of Surgical Outcomes with Photoselective GreenLight XPS Laser Vaporization of the Prostate in High Medical Risk Men with Benign Prostatic Enlargement: A Multicenter Study

Abstract

Objective:

To evaluate the safety and short-term outcomes of photoselective vaporization of the prostate (PVP) using GreenLight XPS™ in treatment of high medical risk (HMR) men.

Methods:

A multicenter retrospective analysis of 941 men who underwent PVP between August 2010 and August 2014 was performed. Patients were considered HMR if they had an American Society of Anesthesiologists physical status score ≥3. Postoperative adverse events, unexpected postoperative medical provider visits after intervention, and functional urinary outcomes were examined.

Results:

HMR men (n = 273) were older (mean age 72.3 ± 8.1 years vs 67.1 ± 9 years, p ≤ 0.01), had larger prostate volumes (82.8 ± 48.2 g vs 73.7 ± 49.4 g, p < 0.01), and were more likely to be on anticoagulant and antiplatelet medications (all p ≤ 0.01). Moreover, overall operative time (65 ± 35.1 minutes vs 53.9 ± 24.9 minutes), energy delivered (313.4 ± 207 kJ vs 258 ± 164 kJ), and energy density used (4.2 ± 3.8 kJ/g vs 3.8 ± 3 kJ/g) were greater in the HMR group (all p ≤ 0.05). Although HMR men were more often treated in a hospital setting (p ≤ 0.01), there were no differences in intraoperative adverse events. At 6 months, both groups had notable improvements from baseline for International Prostate Symptom Score, quality of life due to urinary symptoms, maximum urinary flow rate, postvoid residual urine volume, and prostate-specific antigen. Regarding safety, the two groups had comparable 90-day Clavien-Dindo complication rates, numbers of urgent care visits, and numbers of outpatient consultations. HMR men, however, had more hospital readmissions within 90 days postsurgery (3.7% vs 1.3%; p = 0.04).

Conclusions:

Despite older age, greater comorbidity, and significant use of anticoagulants, HMR men who undergo photoselective vaporization benefit from symptom improvement and show no clinical difference in adverse event profiles. GreenLight-XPS produces similar short-term outcomes in patients with significant comorbidities when compared with healthy patients.

Introduction

The incidence of benign prostatic hyperplasia (BPH) rises significantly with age. Progression of BPH to bladder outlet obstruction (BOO) is one of the most common reasons for urologic consultation, particularly in older men. Despite utilization of medical treatment for BPH, persistent lower urinary tract symptoms (LUTS) secondary to BOO have been associated with reduced quality of life (QoL), medical comorbidities, depression, and increased risk of falls and mortality.¹ Surgical intervention is the mainstay of treatment for refractory obstructive symptoms. Not surprisingly, due to the growing elderly population with greater disease severity and increased use of anticoagulation therapy, modern-day urologists face far more complex patients who require surgical relief of obstruction and who harbor high-risk surgical features.^2

–6 Consequently, the decision to surgically treat high-risk men with symptomatic BPH can be challenging. However, with introduction of new modalities such as laser prostate vaporization, promising outcomes have been observed in reduction of bleeding risk in medically complicated patients on anticoagulant and/or antiplatelet therapy.^7,8

Data suggest that GreenLight™ photoselective vaporization of the prostate (PVP) is less morbid and more cost-effective than transurethral resection of the prostate (TURP).⁹ Its safety in men using anticoagulation^7,8 and efficacy in treating symptomatic BPH have been well reported.^10,11 GOLIATH, the most recent, prospective, randomized, multicenter European study of GreenLight XPS™ (GL-XPS) vs TURP, addressed complication rates between the two groups.^10,11 The GOLIATH study reported statistically significantly fewer adverse events with GL-XPS compared with TURP (p < 0.001) in the early postoperative period (2–30 days), particularly bleeding events.¹⁰ Unfortunately, men characterized as high medical risk (HMR) patients were not included in the study population. In the current study, we evaluated the safety and short-term outcomes of GL-XPS for the treatment of symptomatic BPH in HMR men classified by American Society of Anesthesiologists physical status (ASA-PS) score.

Materials and Methods

Study population

After institutional review board approval, data were collected by retrospective chart review. The study included all patients diagnosed with LUTS secondary to benign prostatic enlargement who underwent GL-XPS laser vaporization from August 2010 to August 2014 at five participating high-volume centers in the United States and Canada. Enrollment totals were 198 subjects at Urology of Virginia, 176 subjects at North Fulton Urology, 198 subjects at Affiliates in Urology, 170 subjects at Houston Metro Urology, and 199 subjects at University of Montreal Hospital Center. Indications for surgery were based on established guidelines of the Canadian Urological Association, the American Urological Association (AUA), and the European Association of Urology (EAU) for the management of BPH and LUTS. Exclusion criteria included prostate cancer, previous radiation therapy, neurological disease, and urethral stricture or urinary incontinence before surgery. All perioperative data were retrospectively collected in a central database.

Outcome measures

Baseline patient characteristics collected included age, International Prostate Symptom Score (IPSS), quality of life due to urinary symptoms (IPSS-QoL), postvoid residual volume (PVR), uroflowmetry for maximum flow rate (Qmax), prostate-specific antigen (PSA), and transrectal ultrasonographic measurement of prostate volume. Perioperative measures, including preoperative urinary retention, operative time (minutes), operative surgical location (e.g., ambulatory surgery center or main operative room), complications, and catheterization time (days), were also analyzed. Primary outcomes included postoperative complications and postoperative medical provider visits after intervention at ≤90 and >90 days. All complications were classified using Clavien-Dindo grades¹² with previously published modifications¹³ and were diagnosed based on the physician's training, experience, and general practice guidelines.

Medical risk classification

The ASA-PS score is a well-known international tool to determine perioperative risk.^14,15 ASA-PS classifications are as follows:

• ASA-PS I: Normal healthy patient.

• ASA-PS II: Patient with mild systemic disease—no functional limitation.

• ASA-PS III: Patient with severe systemic disease—definite functional limitation.

• ASA-PS IV: Patient with severe systemic disease that is a constant threat to life.

Patients were evaluated in a preoperative anesthesia clinic and assessed an ASA-PS score based on comorbidities and risk for surgery. Patients were divided into two groups based on ASA-PS score: group one included healthier men with ASA-PS ≤2 and group two included HMR men with ASA-PS ≥3. All surgical procedures were performed in general hospitals where intensive care units were available.

Statistical analysis

Missing values of the continuous outcome measures were imputed by next observation carried backward. Continuous variables were summarized as mean ± standard deviation and categorical variables as count (proportion), unless otherwise specified. Differences between groups were assessed for statistical significance using the Wilcoxon rank sum test for continuous variables and the chi-square or Fisher exact test for categorical variables. All tests were two-sided and p ≤ 0.05 was considered statistically significant. Calculations were performed using the Statistical Analysis System (SAS, Cary, NC), version 9.2.

Surgical method

All PVP procedures were performed by experienced users of the GreenLight XPS 180 W laser system with standard technique described previously by the International GreenLight user guidelines.¹⁶ Spinal or general anesthesia was selected as per discretion of the anesthesiologist. Antibiotics were administered according to hospital or center protocol. Laser vaporization was started at 80 W and then increased during PVP to 120 W for incision grooves and then to a maximum of 180 W. Power was adjusted according to tissue vaporization speed and prostate volume. For coagulation, the TruCoag™ character pulse was adjusted to 12 Hz and 30–40 W. The surgical endpoint was to evaporate the prostatic tissue to the level of the capsule from the bladder neck to the verumontanum.

Results

Data were obtained for 956 patients, of whom 941 had available ASA-PS scores. The 273 patients having preoperative ASA-PS score III or IV were assigned to the HMR group and the remaining 668 to the control group. Mean follow-up time in the HMR and control group, respectively, was 401 ± 434 and 459 ± 406 days, but data points were not collected past 6 months for the majority of subjects given high attrition. Long-term outcomes could not be assessed due to insufficient data past 6 months. Baseline characteristics of the groups are summarized in Table 1. HMR patients and the control group had comparable Qmax, PVR, and PSA values. However, the HMR patients were significantly older (mean age 72.3 ± 8.1 years vs 67.1 ± 9 years; p ≤ 0.001), had larger prostate volumes (82.8 g vs 73.7 g, p = 0.005), were more likely to be in urinary retention at the time of surgery (30.3% vs 19%, p ≤ 0.001), and were more likely to be on an antiplatelet, anticoagulant, or aspirin medication in contrast to the healthy group (p ≤ 0.001). Additionally, more HMR men remained on anticoagulation during the procedure due to pre-existing medical conditions (5.1% vs 1.6%, p = 0.004). Therapeutic levels of anticoagulation drugs at the time of surgery were unknown.

Table 1.

Baseline Characteristics and Operative Outcomes

Preoperative characteristics	Control group ASA-PS I/II, total = 668	High medical risk group ASA-PS III/IV, total = 273	p
Age (SD)	67.1 ± 9 (34, 67, 95)	72.3 ± 8.1 (51, 72, 94)	<0.001
LUTS duration (years)	2.6 ± 3.6 (0.0, 1.1, 29.8)	3.3 ± 5.7 (0.0, 1.0, 45.9)	0.85
IPSS overall	19.7 ± 8.2 (0, 20, 35)	20 ± 8.8 (0, 21, 35)	0.61
IPSS categories, n (%)
≤8	62 (9.7)	27 (11.2)	0.52
9–21	284 (44.7)	98 (40.5)
>21	290 (45.6)	117 (48.3)
IPSS-QOL	3.9 ± 1.3 (0, 4, 6)	4.1 ± 1.3 (0, 4, 6)	0.03
Qmax (mL/second)	8.6 ± 5.5 (0.0, 7.7, 46.0)	9.0 ± 6.3 (1.0, 7.6, 38.0)	0.91
PVR (mL)	205 ± 222 (0, 131, 1700)	208 ± 223 (0, 133, 999)	0.74
PSA (ng/mL)	4.7 ± 7.3 (0.0, 2.9, 92.7)	5.5 ± 9.6 (0.0, 3.3, 81.3)	0.33
TRUS prostate volume (g)	73.7 ± 49.4 (6.2, 61, 526.2)	82.8 ± 48.2 (12, 74, 285)	0.005
Current BPH medical therapy, n (%)	399 (62.6)	183 (69.8)	0.04
Prior BPH surgery, n (%)	133 (20.1)	62 (22.8)	0.36
Anticoagulant use, n (%)	28 (4.4)	37 (14)	<0.001
Aspirin, n (%)	215 (34)	130 (49.6)	<0.001
Antiplatelet, n (%)	26 (4.1)	33 (12.7)	<0.001
Urinary retention with failed voiding trail/Foley catheter, n (%)	123 (19)	80 (30.3)	<0.001
Procedure location, n (%)
Physician office	37 (5.5)	3 (1.1)
Main operative room	467 (69.9)	243 (89)	<0.001
Ambulatory surgery center	164 (24.6)	27 (9.9)
Intraoperative outcomes
Anesthesia type
General, n (%)	518 (77.5)	246 (90.1)	<0.001
Spinal, n (%)	129 (19.3)	26 (9.5)
Other, n (%)	21 (3.2)	1 (0.4)
Procedure time (minutes)	53.9 ± 24.9 (15, 49, 158)	65 ± 35.1 (12, 58, 210)	<0.001
Laser time (minutes)	31.0 ± 17.1 (3, 27, 107)	38.3 ± 21.7 (4, 35, 113)	<0.001
Energy delivered (kJ)	258 ± 164 (14, 218, 1103)	313.4 ± 207 (31, 256, 1009)	<0.001
Energy density (kJ/TRUS g)	3.8 ± 3 (0.2, 3.4, 60.2)	4.2 ± 3.8 (0.3, 3.5, 52.9)	0.047
Length of stay (days)	0.5 ± 0.5 (0.1, 0.3, 6.1)	0.6 ± 0.4 (0.1, 0.3, 2.5)	<0.001
Length of catheterization (days)	1.1 ± 1 (0.1, 1.0, 10.0)	1.3 ± 1.2 (0.3, 1.0, 14.0)	0.08
No. of fibers used, n (%)
1	617 (92.8)	243 (89)	0.16
2	46 (6.9)	28 (10.3)
≥3	2 (0.3)	2 (0.7)
Intraoperative complications, n (%)
Malfunction of XPS fiber (metal to glass cap detachment)	3 (0.4)	0 (0)	0.56
Intraoperative bleeding	4 (0.6)	1 (0.4)	1.00
Bladder/ureteral injury	0 (0)	1 (0.4)	0.29
Urethral injury	0 (0)	0 (0)	NA
Prostatic capsular perforation	1 (0.1)	0 (0)	1.00

Results are presented as count (percentage) or mean ± standard deviation (min, median, max); p-value is from statistical test of difference between groups.

Bold: p ≤ 0.05 was considered statistically significant.

ASA-PS = American Society of Anesthesiologists physical status; BPH = benign prostatic hyperplasia; IPSS = International Prostate Symptom Score; IPSS-QoL = quality of life due to urinary symptoms; LUTS = lower urinary tract symptoms; PSA = prostate-specific antigen; PVR = postvoid residual urine volume; Qmax = maximum urinary flow rate; TRUS = transrectal ultrasound.

Intraoperative parameters are also listed in Table 1. Compared with the control group, HMR men were more likely to be treated in the hospital main operative room (89% vs 69.9%, p < 0.001) rather than in a physician office or ambulatory surgery center. Overall, operative time, laser time, and delivered energy were higher in the HMR group (p < 0.001).

Treatment-related postoperative adverse events, classified by Clavien-Dindo grades, are summarized in Table 2. Urological and nonurological-related complications were comparable between groups. However, urinary tract infection (UTI) within 90 days post-PVP was more likely in the HMR group (5.5% vs 1.6%; p = 0.003). Further analysis showed that postoperative UTI was not statistically significantly related to preoperative urinary retention or indwelling urethral catheter (p = 0.401, Mantel-Haenszel test).

Table 2.

Postoperative Complications

	≤90 Days			>90 Days
Adverse event	Control group ASA-PS I/II, n (%)	High Medical risk group ASA-PS III/IV, n (%)	p	Control group ASA-PS I/II, n (%)	High Medical risk group ASA-PS III/IV, n (%)	p
Clavien-Dindo Category: Grade 1
Urinary retention^a	1 (0.1)	0 (0)	1.00	0 (0)	0 (0)	NA
Stricture and BNC^a	0 (0)	0 (0)	NA	1 (0.1)	0 (0)	1.00
Urinary incontinence	3 (0.4)	2 (0.7)	0.63	4 (0.6)	2 (0.7)	1.00
ED (de novo)	0 (0)	0 (0)	NA	1 (0.1)	0 (0)	1.00
LUTS	3 (0.4)	2 (0.7)	0.63	1 (0.1)	0 (0)	1.00
Total for category	7 (1)	4 (1.5)	0.74	7 (1)	2 (0.7)	1.00
Clavien-Dindo Category: Grade II
Delayed bleeding and clot retention	4 (0.6)	2 (0.7)	1.00	0 (0)	0 (0)	NA
Hematuria	2 (0.3)	1 (0.4)	1.00	0 (0)	0 (0)	NA
Urinary retention	29 (4.3)	4 (1.5)	0.03	1 (0.1)	0 (0)	1.00
Urethral injury	2 (0.3)	0 (0)	1.00	0 (0)	0 (0)	NA
UTI	11 (1.6)	15 (5.5)	0.003	2 (0.3)	1 (0.4)	1.00
Fever	1 (0.1)	0 (0)	1.00	0 (0)	0 (0)	NA
Nocturia	1 (0.1)	0 (0)	1.00	0 (0)	0 (0)	NA
Urinary incontinence	6 (0.9)	3 (1.1)	0.72	4 (0.6)	0 (0)	0.33
LUTS	30 (4.5)	10 (3.7)	0.72	2 (0.3)	2 (0.7)	0.58
Bladder spasm	1 (0.1)	0 (0)	1.00	0 (0)	0 (0)	NA
Worsening ED	0 (0)	0 (0)	NA	0 (0)	1 (0.4)	0.29
Prostatitis	1 (0.1)	0 (0)	1.00	0 (0)	0 (0)	NA
Cardiac arrhythmia	1 (0.1)	1 (0.4)	0.50	0 (0)	0 (0)	NA
Other	0 (0.0)	1 (0.4)	0.29	1 (0.1)	0 (0.0	1.00
Total for category	78 (11.7)	28 (10.3	0.57	10 (1.5)	4 (1.5)	1.00
Clavien-Dindo Category: Grade IIIa
Total for category	0 (0)	0 (0)	NA	0 (0)	0 (0)	NA
Clavien-Dindo Category: Grade IIIb
Bleeding and clot retention	2 (0.3)	2 (0.7)	0.58	0 (0)	1 (0.4)	0.29
Hematuria	2 (0.3)	2 (0.7)	0.58	1 (0.1)	3 (1.1)	0.08
Sloughing	1 (0.1)	0 (0)	1.00	0 (0)	0 (0)	NA
Urinary retention	2 (0.3)	2 (0.7)	0.58	1 (0.1)	1 (0.4)	0.50
Stricture and BNC	4 (0.6)	0 (0)	0.33	12 (1.8)	3 (1.1)	0.57
Urinary incontinence	2 (0.3)	0 (0)	1.00	1 (0.1)	0 (0)	1.00
Worsening LUTS	0 (0)	3 (1.1)	0.02	0 (0)	0 (0)	NA
Renal insufficiency	0 (0)	1 (0.4)	0.29	0 (0)	0 (0)	NA
Total for category	13 (1.9)	10 (3.7)	0.16	15 (2.2)	6 (2.2)	1.00
Total of Clavien-Dindo Grades I–IIIb	94 (14.1)	38 (13.9)	1.00	30 (4.5)	12 (4.4)	1.00

Treatment-related adverse events by Uro-Clavien-Dindo Classification and onset time; No. (proportion) of patients.

No treatment was recorded for these events.

BNC = bladder neck contracture; ED = erectile dysfunction; NA = not applicable; UTI = urinary tract infection.

To control for the possible effect of anticoagulation therapy, a subgroup analysis of adverse events was performed, including only subjects who remained on anticoagulation perioperatively (HMR: n = 14, control: n = 11). The number of adverse events observed in the subgroup was five in the HMR group and one in the control group, but there was no statistically significant difference between the groups.

In the overall study population, a comparable number of men in the HMR and control groups sought medical attention postoperatively in emergency room or outpatient settings, but significantly more HMR patients were readmitted to the hospital compared with the control group in early (≤90 days) follow-up (p = 0.04) and long-term (>90 days) follow-up (p = 0.03) (Table 3). Reasons for admission within 90 days are listed in Table 4. Although both study arms have comparable incidence of bladder neck contracture and urethral stricture incidence (Table 2), HMR men more frequently required hospital admission to monitor their medical conditions during corrective procedures for outflow obstruction.

Table 3.

All Unexpected Postoperative Medical Provider and Urologist Visits Post Intervention

	≤90 Days			>90 Days
Type of visit	Control group ASA-PS I/II, n (%)	High medical risk group ASA-PS III/IV, n (%)	p	Control group ASA-PS I/II, n (%)	High medical risk group ASA-PS III/IV, n (%)	p
Emergency room/urgent care visit	32 (4.8)	12 (4.4)	0.87	2 (0.3)	1 (0.4)	1.00
Hospitalization/Admission	9 (1.3)	10 (3.7)	0.04	1 (0.1)	4 (1.5)	0.03
Outpatient visit	61 (9.1)	23 (8.4)	0.80	30 (4.5)	9 (3.3)	0.47

No. (proportion) of patients.

Bold: p ≤ 0.05 was considered statistically significant.

Table 4.

Treatment-Related Complications Leading to Readmission Within 90 Days Postprocedure

High medical risk group ASA-PS III/IV	Sepsis (n = 5)
	• Pneumonia (n = 2)
	• Urinary tract infection (n = 3)
	Hematuria with clot retention (n = 3)
	Cardiac arrhythmia (n = 1)
	Acute renal failure (n = 1)
	Total (n = 10)
Control group ASA-PS I/II	Antibiotic-resistant urinary tract infection (n = 3)
	Hematuria with clot retention (n = 3)
	Urinary retention (n = 1)
	Cardiac arrhythmia (n = 1)
	Traumatic urethral injury from urethral catheter (n = 1)
	Total (n = 9)

At 6-month postoperative follow-up, IPSS and IPSS-QoL scores were significantly improved compared with baseline in both groups (Tables 1 and 5); IPSS decreased from 19.7 ± 8.2 to 5.7 ± 4.8 in the control group and from 20 ± 8.8 to 7.7 ± 7.0 in the HMR group. IPSS-QoL decreased from 3.9 ± 1.3 to 1.2 ± 1.2 in the control group and from 4.1 ± 1.3 to 1.6 ± 1.5 in the HMR group. Meanwhile, Qmax was significantly increased in each group compared with baseline level, 8.6 ± 5.5 to 18.9 ± 8.8 mL/second vs 9.0 ± 6.3 to 15.3 ± 8.8 mL/second in control group and HMR patients, respectively. PVR also decreased significantly from baseline, 205 ± 222 to 42.9 ± 90.0 mL vs 208 ± 223 to 55.9 ± 107.7 mL in control group and HMR patients, respectively. Additionally, PSA decreased significantly from baseline, 4.7 ± 7.3 to 2.1 ± 4.0 ng/mL vs 5.5 ± 9.6 to 2.2 ± 5.4 ng/mL in control group and HMR patients, respectively. However, when comparing HMR patients with the control group at 6 months postprocedure (Table 5), overall improvement in IPSS, IPSS-QoL, and Qmax was not as pronounced in HMR patients as in healthier patients (p ≤ 0.05).

Table 5.

Postoperative IPSS, QOL, Qmax, PVR, and PSA at 6 Months

	Control group ASA-PS I/II	High Medical Risk group ASA-PS III/IV	p^b
IPSS
Mean	5.7 ± 4.8	7.7 ± 7.0
Min, median, max	0, 5, 29	0, 5, 32	0.02
No.	405	156
IPSS-QOL
Mean	1.2 ± 1.2	1.6 ± 1.5
Min, median, max	0, 1, 6	0, 1, 6	<0.001
No.	397	141
Qmax (mL/second)
Mean	18.9 ± 8.8	15.3 ± 8.8
Min, median, max	0.0, 20.0, 73.0	0.0, 14.4, 52.0	<0.001
No.	310	98
PVR (mL)
Mean	42.9 ± 90.9	55.9 ± 107.7
Min, median, max	0.0, 15.0, 954.0	0.0, 20.0, 999.0	0.30
No.	428	149
PSA (ng/mL)
Mean	2.1 ± 4.0	2.2 ± 5.4
Min, median, max	0.0, 1.0, 50.0	0.0, 1.2, 106.0	0.421
No.	387	108
Mean PSAΔ^a	−42.2%	−35.8%	NA
Median PSAΔ	−56.7%	−65.5%

Mean of PSA change calculated on a per-patient basis.

p-Value shows difference between control and high medical risk groups.

Bold: p ≤ 0.05 was considered statistically significant.

QoL = quality of life due to urinary symptoms.

Discussion

BPH is among the most common urological disorders in men. With regard to surgical management, increasing demand for minimally invasive procedures to relieve symptomatic BPH has led to the development of laser procedures in the past 20 years as an alternative to TURP.⁹ Given the advantages of improved hemostasis, efficient tissue removal, reduced operative time, and hospital stay in comparison with standard transurethral resection,¹⁷ GL-XPS is thought to be more suitable for patients with more severe medical problems, and there is a growing level of evidence supporting this hypothesis. GL-XPS safety has also been addressed in the literature for its efficacy in large prostate volumes (>80 g) and patients on anticoagulants.^7,18
–20 Moreover, the current EAU guidelines recommend PVP as a treatment option, particularly for high-risk anticoagulated patients.³ Multiple studies have demonstrated the safety and efficacy of previous generations of GreenLight in HMR and/or anticoagulated patients.^8,21
–23 However, to this date, there are limited clinical data on PVP specifically in HMR men treated with the latest GL-XPS system.

Findings in our study confirm the safety and efficacy of GL-XPS for the treatment of symptomatic BPH in men with HMR. Despite HMR, including older age and use of anticoagulants, the prevalence of operative complications was low and clinical outcomes were comparable with the healthier control group. The only early postoperative urinary adverse event with a statistically significant difference in the HMR group vs control group was UTI (5.5% vs 1.6%; p = 0.003) at ≤90 days. The Mantel-Haenszel test did not show a statistically significant relationship between UTI and preoperative retention/indwelling catheter despite the greater incidence of urinary retention in the HMR group at baseline. No differences in complication rates were seen in the >90-day time frame for the HMR group vs healthier group. Intraoperative differences included higher operative time, laser time, and delivered energy in the HMR group, which correlated with the larger prostate volume of HMR men (82.8 ± 48.2 g vs 73.7 ± 49.4 g). Hueber and colleagues observed the same relationship in their study of 180 W PVP in patients with larger prostates; there were greater total operative time, laser time, and energy delivered in prostates larger than 80 cc.¹⁸

As for the efficacy of our study, Qmax increased significantly in the HMR and control groups from 9.0 ± 6.3 and 8.6 ± 5.5 mL/second at baseline, respectively, to 15.3 ± 8.8 and 18.9 ± 8.8 mL/second at 6-month follow-up. Both groups showed Qmax values greater than 15 mL/second, which is suggestive of a nonobstructed state.²⁴ Similar Qmax improvements were seen in Lee and colleagues' recent study of anticoagulated patients treated with GL-XPS. Baseline Qmax was 8.7 (5.3–11.7) mL/second in the anticoagulated group and 6.3 (3–11) mL/second in the no anticoagulation group and increased to 18.2 (12.9–22.5) and 12.9 (9.2–20.3) mL/second, respectively, at 6 months.⁷

At 6-month follow-up, IPSS and IPSS-QoL were also significantly improved compared with baseline in our study, but the overall improvement was not as marked in HMR patients as in the healthier patients. Such findings could be attributed to the older age of the HMR group, chronic retention, reduced bladder contractility, and comorbidities. When we examined 6-month outcomes in both groups excluding the men in retention, there was no statistical difference in IPSS (6.0 ± 5.1 in control vs 7.8 ± 7.2 in HMR; p = 0.143). Other studies have shown that worse IPSS and IPSS-QoL scores can be related to many factors, including advanced age, prostate volume, cardiovascular disease, insulin resistance, obesity, and degree and duration of preoperative urinary outflow obstruction.^25
–27 In the GOLIATH study, noninferiority was observed in IPSS and IPSS-QoL between GL-XPS and TURP at 6-month follow-up and was maintained at 12- and 24-month follow-up.^10,11 Therefore, we can conclude that the associations of slightly higher functional symptoms score index in HMR patients are mostly related to the associated preoperative comorbidity. Interestingly, our control group was observed to have more acute urinary retention at catheter removal shortly after the procedure (4.3% vs 1.5%; p = 0.03). However, 19.3% of healthier group had spinal anesthesia, which could contribute to the increased perioperative urinary retention. Furthermore, timing after surgery for catheter removal varied between surgeons and the too early trial may also have played a role in such incidence.

Previous studies have shown multiple general benefits of GL-XPS over TURP, many of which can be applied to the HMR population. Teng and colleagues conducted a systematic review for comparison of PVP and TURP that showed advantages of GL-XPS in terms of blood loss, transfusion, transurethral resection syndrome, capsular perforation, catheterization time, and hospital stay.²⁸ Similarly, a systematic review of randomized controlled trials by Thangasamy and colleagues further supported shorter hospital stay and significantly less bleeding and clot retention favoring PVP.²⁹ The recent GOLIATH study also assessed safety and efficacy of GL-XPS in a multicenter, prospective, randomized control design. Noninferiority was observed in overall treatment-related adverse events; complication-free rate at 24 months was 83.6% after GL-XPS vs 78.9% after TURP; difference: 4.7%, 95% CI: −5.0, 14.4.¹¹ Significant benefits of PVP were observed during the early postoperative period, 48 hours to 30 days, with 12 adverse events in the TURP group, including bleeding events and no adverse events in the GL-XPS patients (p < 0.001).¹⁰ Regarding the influence of patient age on PVP outcomes, Gu and colleagues and Majumdar and colleagues both observed a low frequency of adverse events and comparable clinical efficacy when comparing older with younger men.^25,30

In an era of cost containment and reduction of secondary medical care following surgery, we observed that HMR men have comparable unexpected visits following PVP surgery (outpatient medical centers or emergency visits). However, patients who visited the emergency or urgent care departments and were ultimately hospitalized were more likely to be HMR patients, predominantly due to infections and bleeding complications.

This study is not without its limitations. Although we used the ASA-PS system in assessing overall patient risk, further stratification of comorbidities using the Charlson comorbidity index might offer a better estimation of disease burden and mortality risk. Furthermore, the fact that PVP procedures were performed at five different medical centers may have contributed to variability in our results. Additionally, this was a retrospective study with a relatively short follow-up time of 6 months. Despite these limitations, we assessed the GL-XPS modality in overall HMR individuals, irrespective of urological risk, a population typically excluded from surgical BPH studies. Our study offers additional outcome data on HMR men treated with GL-XPS by expert urologists. Further prospective randomized studies are needed to determine long-term outcomes of GL-XPS in this population.

Conclusions

Despite older age, increased comorbidities, and higher use of anticoagulants, HMR men (ASA-PS III/IV) who undergo GL-XPS experience symptom improvement and postoperative complications similar to healthier men (ASA-PS I/II). GL-XPS produces safe and effective short-term outcomes in patients with more severe disease states.

Footnotes

Acknowledgments

The authors would like to thank Golnaz Venkatraman, PharmD (Boston Scientific Corporation), for assistance with manuscript editing and Paul Zantek, PhD (Boston Scientific Corporation), for statistical analysis. Furthermore, the publication manuscript data and abstract have also been presented at the American Urological Association 2016 Annual meeting and Canadian Urological Association 2016 Annual meeting, as well as the Societe d'Urologie International 2016 meetings, as published abstracts.

Author Disclosure Statement

E.R., C.T., P.-A.H., A.M.A., R.V., and M.A. have no disclosures to declare. R.R.G., G.E., L.K., M.H., and K.C.Z. serve as consultants to Boston Scientific Corporation for GreenLight XPS.

Abbreviations Used

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