Abstract
This study aims to conduct a cost-effectiveness analysis of three different anesthesia strategies, namely chatting while under local anesthesia (Chat-LA), total intravenous anesthesia (TIVA), and general anesthesia with laryngeal mask airway (GA-LMA), employed in transperineal magnetic resonance imaging (MRI)/ultrasound (US) fusion prostate biopsy (TP-MUF-PB). A retrospective study was conducted involving 1202 patients who underwent TP-MUF-PB from June 2016 to April 2023 at The First Affiliated Hospital of Soochow University (Suzhou, China). Clinical data and outcomes, including total costs, complications, and quality-adjusted life years (QALYs), were compared. Probability sensitivity and subgroup analyses were also performed. Chat-LA was found to be the most cost-effective option, outperforming both TIVA and GA-LMA. However, subgroup analyses revealed that in younger patients (under 65 years old) and those with smaller prostate volumes (<40 ml), TIVA emerged as a more cost-effective strategy. While Chat-LA may generally be the most cost-effective and safer anesthesia method for TP-MUF-PB, personalization of anesthesia strategies is crucial, considering specific patient demographics such as age and prostate volume.
Keywords: anesthesia strategy, cost-effectiveness analysis, economic evaluation, prostate biopsy, prostate cancer
INTRODUCTION
Prostate cancer (PCa) is a common cancer that affects approximately 250 000 men annually worldwide.1 The gold standard for diagnosing PCa is prostate biopsy (PB).2 While the transrectal (TR) approach is widely used for PCa detection,3 a cumulative study4 has shown that the transperineal (TP) approach has comparable PCa detection rates with significantly lower rates of major complications. Consequently, the European Association of Urology (EAU) has recommended a switch from the TR to TP approach.5 Multiparameter magnetic resonance imaging (mpMRI) is increasingly used to diagnose patients with PCa.6,7 Currently, several studies suggest that TP MRI/ultrasound (US) fusion PB (TP-MUF-PB) can detect more clinically significant prostate cancer (csPCa).8–10 However, the main disadvantage of the TP approach for PB is poor pain control. Nearly 75% of TP-PB studies use spinal or general anesthesia (GA) instead of local anesthesia (LA) to alleviate intolerable pain.8 Recent advancements in perineal anesthesia techniques have enabled the use of LA exclusively, which has been shown to provide better pain control than GA or spinal anesthesia.11 Currently, there are few studies on anesthesia strategies for TP-MUF-PB. Our study aims to evaluate the effectiveness, comfort, safety, and cost-effectiveness of TP-MUF-PB under different anesthesia strategies, with the goal of finding the optimal anesthesia strategy for TP-MUF-PB.
PATIENTS AND METHODS
Patients recruitment and characteristics
In this retrospective cohort study, a total of 1535 male patients with TP-PB were recruited at The First Affiliated Hospital of Soochow University (Suzhou, China) from June 2016 to April 2023. Of these patients, 106 had previously received treatment, 148 had a prostate-specific antigen (PSA) level >100 ng ml−1, 79 were unable to undergo MRI examinations, and 1202 underwent TP-MUF-PB. Among them, 285 patients adopted the chatting while under LA (Chat-LA) strategy. Patients with hearing impairments or those unable to communicate verbally did not select Chat-LA. Moreover, 405 patients adopted the total intravenous anesthesia (TIVA) strategy, while 512 patients adopted the GA with laryngeal mask airway (GA-LMA) strategy. The choice of anesthesia method for patients is primarily determined by the following factors: (1) patient’s autonomous choice and (2) assessment of the patient’s conditions by the anesthesiologist. The research has been performed in accordance with the Declaration of Helsinki. All patients were counseled about the purpose, risks, and benefits of the procedure, and then, they signed an informed consent form that included permission to use their clinical data for research. The study was approved by the Institutional Review Board of The First Affiliated Hospital of Soochow University (Approval No. 2023516).
The patients’ age, prebiopsy PSA, free/total PSA (f/tPSA), biopsy cores, and pathological features were included in this study. The included MRI characteristics were Prostate Imaging-Reporting and Data System (PI-RADS) which was graded according to PI-RADS version 2 by the same radiologist who assessed more than 500 prostate MRI readings, prostate volume (PV) on mpMRI (PV = 0.52 × height × length × width), and the PSA density (PSAD; PSAD = PSA/PV).
Pain and complications
A Visual Analog Scale (VAS), ranging from 0 to 10, was used to record the pain experienced by Chat-LA patients during the procedure. Based on previous studies,11,12 we considered a VAS score >3 to indicate moderate-to-severe pain during the biopsy procedure. We also arranged follow-up visits to inquire whether patients would consider undergoing LA again for any future biopsies. Within 1 month after PB, the complications were recorded using the Clavien–Dindo grading system.13 This system classifies clinically relevant complications such as postoperative urinary retention (POUR), hematuria, infectious complications, and symptoms associated with GA.
Anesthesia and prostate biopsy procedure
Patients were given oral lactulose (30 ml, once) 1 day before biopsy, and fasting was not required. No sedation or other anesthesia was given before or after the procedure. The mpMRI images were imported into the real-time virtual sonography (RVS) ultrasonography host (Fuji Film, Tokyo, Japan). The target lesion was marked, and patients were placed in the lithotomy position. The Chat-LA strategy involved several steps. The perineum area was exposed and disinfected with an iodophor solution. A 20-ml dose of 2% lidocaine gel was applied to the biopsy area. The optimal skin entry point was chosen at 45° ventrally and 1.5 cm from the anus,9 and 10 ml of 1% lidocaine was injected bilaterally between the deep superficial fascial layer and the prostate capsule. For GA-LMA strategy, anesthesia induction was achieved by intravenous injection of sedatives, analgesics, and a small amount of muscle relaxants. Intravenous infusion of propofol or inhalation of sevoflurane was used to maintain anesthesia. Airway management is achieved by inserting LMA. In the TIVA strategy, based on the anesthesiologist’s judgment, moderate-to-deep sedation was maintained by intravenous injection of propofol or other sedative drugs, combined with a small amount of analgesics. During the biopsy procedure, the urologist performed TB, with each target lesion being executed on a 2-core biopsy. After TB completion, the urologist continued to perform a 12-core systematic biopsy (SB). During the Chat-LA strategy, the urologist chatted with the patient to distract their attention and achieve the goal of reducing pain. All specimens were fixed in 10% formalin and then subjected to pathological analysis. The operation time was measured from the beginning of anesthesia to the end of the biopsy procedure. The preparation time before biopsy was not included in the measurement.
Cost measurement
We recorded the relevant costs for three groups of patients, with an observation period of 1 month. The costs were categorized as follows: (1) PSA testing costs and mpMRI examination costs; (2) anesthesia-related costs; (3) PB procedure costs; (4) hospitalization-related costs (including bed fees, nursing fees, and medical expenses); (5) complication treatment costs; and (6) pathological examination costs. The specific cost details can be found in Table 1. All the costs noted above were reported in China Yuan (CNY) and converted to United States Dollar (USD) using the average exchange rate (1 USD ≈ 6.73 CNY) in 2022.14 We evaluated the cost-effectiveness when making decisions at a single time point; therefore, the impacts of inflation and the annual discount rate were not considered in the analyses.
Table 1.
Total costs used in cost-effectiveness model
| Parameter | Cost (CNY), median (IQR) | Cost (USD), median (IQR) |
|---|---|---|
| PSA test | 130.00 (130.00–130.00) | 19.32 (19.32–19.32) |
| Biopsy procedure | 1200.28 (1200.28–1200.28) | 178.35 (178.35–178.35) |
| Pathological tests | 889.00 (889.00–889.00) | 132.09 (132.09–132.09) |
| Chat-LA procedure | 193.67 (193.67–193.67) | 28.78 (28.78–28.78) |
| GA-LMA procedure | 1579.79 (1471.07–1669.19) | 234.74 (218.58–248.02) |
| TIVA procedure | 716.76 (675.76–861.10) | 106.50 (100.41–127.95) |
| Hospitalization-related cost per day | 132.00 (132.00–132.00) | 19.61 (19.61–19.61) |
| Complication-related cost | 33.15 (31.50–48.95) | 4.93 (4.68–7.27) |
| mpMRI examination | 1533.70 (1533.70–1533.70) | 227.89 (227.89–227.89) |
1 USD ≈ 6.73 CNY in 2022. CNY: China Yuan; USD: Untied State Dollar; PSA: prostate-specific antigen; Chat-LA: chatting while under local anesthesia; TIVA: total intravenous anesthesia; GA-LMA: general anesthesia with laryngeal mask airway; mpMRI: multiparameter magnetic resonance imaging; IQR: interquartile range
Health utilities and outcome measures
We measured the cost-effectiveness using quality-adjusted life years (QALYs). QALYs were calculated by multiplying survival with the quality of life in relation to the health status (ranging between 0 and 1, representing death and perfect health, respectively) and duration of health states to calculate the loss of quality of life (QoL). We assigned a utility value of PB of 0.90, and its duration of 3 weeks according to previous studies.15,16 Age and varying complication rates resulting from biopsies led to utility decrements. We assigned a utility value of complication of 0.101, with a duration of 2 weeks.17,18 The calculation of utility decrement of age was 0.0002587+0.0000332×(age2−[age−1]2).19 To calculate the incremental cost-effectiveness ratio (ICER), we divided the estimated cost difference by the difference in effectiveness. The threshold of willingness to pay (WTP) per QALY is the amount of money that the society is willing to pay for one additional QALY. Two WTP thresholds were estimated based on the World Health Organization (WHO) recommendation as one or 3 times the average gross domestic product (GDP) per capita of China from 2016 to 2022.20 These thresholds were set at 10 348 USD and 31 043 USD per QALY, respectively.21 To evaluate the cost-effectiveness of different strategies, the results were interpreted as follows. It would be considered very cost-effective if the ICER was <10 348 USD per QALY, cost-effective if the ICER was between 10 348 USD and 31 043 USD per QALY gained, and not cost-effective for the remainder.
Sensitivity analysis
We performed a probabilistic sensitivity analysis using Monte Carlo simulation with 10 000 iterations, which involved randomly selecting parameter values from their specified probability distributions. The results of probabilistic sensitivity analysis were presented in cost-effectiveness plane and cost-effectiveness acceptability curves (CEAC).
Statistical analyses
Categorical variables, and skewed distribution continuous variables were analyzed using the Pearson’s Chi-squared test, and Mann–Whitney U test, respectively. Cost-effectiveness plane and CEAC were constructed by R-4.2.2 (R Foundation for Statistical Computing, Vienna, Austria). Other statistical tests were conducted with SPSS version 22.0 (IBM Corp, Armonk, NY, USA). All reported P-values were two-sided, and the level of statistical significance was set at P < 0.05.
RESULTS
Demographic and clinical characteristics
Table 2 presents the clinical data of patients in the three groups. Significant differences were observed in age (Chat-LA vs TIVA: 70 years old vs 67 years old, P = 0.002), f/tPSA (Chat-LA vs TIVA: 0.139 vs 0.125, P = 0.002), PV (GA-LMA vs TIVA: 45.7 ml vs 38.4 ml, P = 0.001), and PSAD (GA-LMA vs TIVA: 0.23 ng ml-2 vs 0.26 ng ml-2, P = 0.022). However, there was no statistically significant difference in the remaining inter-group comparisons. Table 2 also displays the distribution of PI-RADS, biopsy cores, and the International Society of Urological Pathology grade group (ISUP GG) as well as hospitalization time and operation time. The cancer detection rate (CDR) did not show a statistically significant difference among the three groups of patients (all P>0.05). We can also find the incidence of complications in the table, with the pain incidence of Chat-LA being 9.8%, symptoms associated with GA being 5.4% and 11.1% for GA-LMA and TIVA, respectively. The incidence of hematuria, infection, and POUR for Chat-LA was 9.1%, 0.1%, and 1.4%, respectively. For TIVA, they were 9.6%, 0.7%, and 7.7%, respectively, while for GA-LMA, they were 9.8%, 0.6%, and 10.0%, respectively. We followed up with all patients who underwent Chat-LA, and 89.1% (254/285) of them stated that they are willing to receive LA again if a repeated biopsy is needed.
Table 2.
Patients demographics enrolled in Chat-LA, TIVA, and GA-LMA groups
| Parameter | Chat-LA (total=285) | TIVA (total=405) | GA-LMA (total=512) |
|---|---|---|---|
| Age (year), median (IQR) | 70 (65–75) | 67 (62–74) | 69 (63–74) |
| PSA (ng ml−1), median (IQR) | 9.69 (6.57–16.41) | 10.98 (6.85–17.99) | 10.49 (6.59–18.92) |
| f/tPSA, median (IQR) | 0.139 (0.093–0.210) | 0.125 (0.081–0.174) | 0.135 (0.090–0.186) |
| PV (ml), median (IQR) | 40.9 (29.5–64.8) | 38.4 (27.6–59.5) | 45.7 (31.2–65.1) |
| PSAD (ng ml−2), median (IQR) | 0.24 (0.12–0.46) | 0.26 (0.17–0.44) | 0.23 (0.12–0.47) |
| PI-RADS, n (%) | |||
| 2 | 62 (21.8) | 74 (18.3) | 104 (20.3) |
| 3 | 76 (26.7) | 117 (28.9) | 149 (29.1) |
| 4 | 86 (30.2) | 109 (26.9) | 125 (24.4) |
| 5 | 61 (21.4) | 105 (25.9) | 134 (26.2) |
| ISUP GG, n (%) | |||
| Benign | 141 (49.5) | 205 (50.6) | 265 (51.8) |
| 1 | 20 (7.0) | 47 (11.6) | 29 (5.7) |
| 2 | 46 (16.1) | 61 (15.1) | 81 (15.8) |
| 3 | 43 (15.1) | 52 (12.8) | 61 (11.9) |
| 4 | 26 (9.1) | 18 (4.4) | 39 (7.6) |
| 5 | 9 (3.2) | 22 (5.4) | 37 (7.2) |
| Number of biopsy cores, median (IQR) | 14 (14–16) | 14 (14–14) | 14 (14–16) |
| Complication, n (%) | |||
| Pain (VAS score >3) | 28 (9.8) | NA | NA |
| Symptoms associated with GA | NA | 22 (5.4) | 57 (11.1) |
| Hematuria | 26 (9.1) | 39 (9.6) | 50 (9.8) |
| Urinary tract infection | 1 (0.4) | 3 (0.7) | 3 (0.6) |
| POUR | 4 (1.4) | 31 (7.7) | 51 (10.0) |
| Operation time (min), median (IQR) | 9 (8–11) | 12 (10–14) | 13 (12–15) |
| Hospitalization time (h), median (IQR) | 4 (3–5) | 48 (45–50) | 48 (45–50) |
| LA willingness during repeat biopsy, n (%) | 254 (89.1) | NA | NA |
LA: local anesthesia; GA: general anesthesia; Chat-LA: chatting while under LA; TIVA: total intravenous anesthesia; GA-LMA: GA with laryngeal mask airway; PSA: prostate-specific antigen; f/tPSA: free/total prostate-specific antigen; PV: prostate volume; PSAD: prostate-specific antigen density; PI-RADS: Prostate Imaging-Reporting and Data System; ISUP GG: International Society of Urological Pathology grade group; VAS: Visual Analog Scale; POUR: postoperative urinary retention; IQR: interquartile range; NA: not available
Base case analyses
Table 3 presents the results of the base case analyses. The mean total costs for Chat-LA, TIVA, and GA-LMA were 608.18 USD, 721.36 USD, and 838.98 USD, respectively. The expected effects were 0.8842 QALYs, 0.8838 QALYs, and 0.8805 QALYs, respectively. TIVA and GA-LMA were dominated by Chat-LA. In comparison between TIVA and GA-LMA, TIVA was dominant. This implies that Chat-LA is a superior strategy compared to the other two, while TIVA is superior to GA-LMA.
Table 3.
Incremental costs and effectiveness and incremental cost-effectiveness ratios in base case analysis
| Strategy | Comparator | Total cost (USD) | Incremental cost (USD) | Total effectiveness (QALYs gained) | Incremental effectiveness (QALYs gained) | ICER (USD per QALY) |
|---|---|---|---|---|---|---|
| Chat-LA | NA | 608.18 | NA | 0.8842 | NA | NA |
| TIVA | Chat-LA | 721.36 | 113.18 | 0.8838 | −0.0004 | Dominated |
| GA-LMA | Chat-LA | 838.98 | 230.80 | 0.8805 | −0.0037 | Dominated |
| GA-LMA | TIVA | 838.98 | 117.62 | 0.8805 | −0.0033 | Dominated |
Chat-LA: chatting while under local anesthesia; TIVA: total intravenous anesthesia; GA-LMA: general anesthesia with laryngeal mask airway; QALYs: quality-adjusted life years; ICER: incremental cost-effectiveness ratio; NA: not available; USD: Untied State Dollar
Probability sensitivity analyses
On the cost-effectiveness plane (Figure 1), using Chat-LA as the reference strategy, most of the TIVA and GA-LMA points are located in the northwest quadrant, with a small portion in the northeast quadrant. This indicates that Chat-LA dominates most of the TIVA and GA-LMA strategies, but there is a small portion of TIVA and GA-LMA strategies that have better effectiveness at higher costs compared to GA-LMA. The CEAC also showed that the Chat-LA strategy had a 100% probability of being more cost-effective, regardless of the WTP threshold. TIVA was ranked second, while GA-LMA was the least cost-effective (Figure 2).
Figure 1.
Cost-effectiveness plane of the three anesthesia strategies. The diamonds represent the mean value of the three strategies, and the scatter plots represent each individual case. Chat-LA: chatting while under local anesthesia; TIVA: total intravenous anesthesia; GA-LMA: general anesthesia with laryngeal mask airway.
Figure 2.
Cost-effectiveness acceptability curves of the three anesthesia strategies. Chat-LA: chatting while under local anesthesia; TIVA: total intravenous anesthesia; GA-LMA: general anesthesia with laryngeal mask airway.
The distributional impact of the interventions on different subgroups
In Figure 3a, by dividing age into three subgroups: under 65 years old, 65–75 years old, and over 75 years old, we can see that in the subgroup under 65 years old, the ICER of Chat-LA is 19 786.88 USD, which is less than 31 043 USD, indicating cost-effectiveness when compared to TIVA. In other age groups, Chat-LA dominates. In Figure 3b, by dividing PV into three subgroups (<40 ml, 40–70 ml, and >70 ml), we observe that in the subgroup with <40 ml volume, with TIVA as reference, the ICER of Chat-LA is 23 586.84 USD, which is less than 31 043 USD.
Figure 3.
Comparison of incremental cost-effectiveness ratio (ICER) between three anesthesia strategies in subgroups of (a) age and (b) prostate volume. Chat-LA: chatting while under local anesthesia; TIVA: total intravenous anesthesia; GA-LMA: general anesthesia with laryngeal mask airway.
DISCUSSION
Regardless of the anesthesia strategy used, TP-MUF-PB was completed, and the CDR did not differ significantly. From the perspective of patient complications, Chat-LA showed better pain control, and the VAS scores were comparable to those reported in previous studies.4,9,22,23,24 This may be attributed to the improved anesthesia method used in the perineal nerve block technique, which was more suitable for anesthetizing the biopsy site, and the use of lidocaine gel to reduce the pain associated with skin puncture. According to the Gate Control Theory of Pain, proposed by Melzack et al.,25 nonpainful input can close the “gates” to painful input, preventing pain sensation from traveling to the central nervous system. Distraction techniques, such as engaging in conversation or other activities, can serve as this nonpainful input. Shifting an individual’s attention away from the pain can effectively “close the gates”, reducing or blocking the perception of pain.
Regarding complications such as hematuria, there were significant differences in the reported incidence in previous studies.4,9,22,23,24 We believe this may be due to variations in the criteria used to define the need for drug intervention. Overall, various anesthesia strategies had no significant effect on the incidence of hematuria. In terms of POUR, the incidence rate was significantly lower in Chat-LA than those in TIVA and GA-LMA, which can be attributed mainly to the inhibitory effects of propofol and sevoflurane on detrusor contractions. The urodynamic effects of volatile anesthetics and sedative-hypnotic agents on the bladder are caused by the inhibition of the pontine micturition center and the voluntary control of the cortex.26
When conducting a cost-effectiveness plane analysis of the three strategies, TIVA and GA-LMA mostly fell in the northwest quadrant compared to Chat-LA, indicating that these two strategies were “dominated” by Chat-LA. A small portion fell in the northeast quadrant, indicating that it is necessary to weigh whether the additional benefits are worth the additional costs. In other words, Chat-LA is generally the more favorable approach in most situations. In the probability sensitivity analysis, we found that Chat-LA was more advantageous across almost all WTP thresholds, with TIVA following closely behind and GA-LMA emerging as the less favorable option.
Future anesthesia strategies should be personalized, and our subgroup analyses showed that for patients under the age of 65 years, TIVA may be a more cost-effective option compared to Chat-LA. Younger patients generally require painless medical care for a better pain experience.27 In general, age is considered a risk factor for adverse outcomes after surgical interventions due to physiological changes associated with aging and a higher likelihood of having other health conditions.28,29,30 In addition, POUR has been shown to increase with age, with patients over 50 years old having a 2.4 times higher risk.26 This could make TIVA more advantageous than Chat-LA for patients with PV less than 40 ml. These patients have a lower chance of low urinary tract obstruction.
Our study has several limitations. First, the study’s retrospective design inherently introduces the potential for selection bias and unmeasured confounding factors, which could impact the reliability of our findings. Second, the choice of different anesthesia techniques might have been influenced by factors not considered in our study, such as the anesthesiologist’s preference or experience, thereby introducing potential bias. Third, in retrospective studies utilizing QALYs, we rely on assumptions from existing literature due to lack of QoL data. These assumptions may not accurately represent the population under study and could introduce bias. Fourth, the decision not to conduct VAS assessments for patients undergoing TIVA may potentially influence the accuracy of pain assessment in this group. Finally, our study was not designed to capture long-term outcomes or rare complications related to the different anesthesia strategies. Future prospective studies with larger, more diverse patient populations and longer follow-up periods are needed to confirm our findings.
CONCLUSIONS
Our findings suggest that the Chat-LA strategy may generally be more cost-effective and less prone to complications. However, in younger patients and those with a smaller PV, TIVA might be a more cost-effective option. Further research is warranted to verify these findings in different settings and populations and to investigate long-term outcomes related to the various anesthesia strategies.
AUTHOR CONTRIBUTIONS
DJ helped in project development, data analysis, and wrote the manuscript. XQK was involved in project development and data collection and wrote the manuscript. YJZ was involved in data collection and analysis, and wrote the manuscript. ZXC and XMW helped in data analysis. CHX performed the statistical analysis. JXP helped to draft the manuscript. JQH and YHH helped in project development. FHJ helped in data analysis and draft the manuscript. CH helped in project development and edited the manuscript. All authors read and approved the final manuscript.
COMPETING INTERESTS
All authors declare no competing interests.
ACKNOWLEDGMENTS
This work was supported by a grant from Key Medical Research Projects in Jiangsu Province (No. ZD2022021) and a grant from the Key Research and Development Program of Jiangsu Province (No. BE2020654).
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