Take Home Message
Extraperitoneal single-port ureteral reimplantation via low anterior access is feasible and safe. Our study results demonstrate preliminary outcomes with good perioperative and mid-term functional results.
Keywords: Ureteral stenosis, Ureteral reimplantation, Single port, Low anterior access, Extraperitoneal, Supine
Abstract
Background and objective
Multiport robotic management of distal ureteral strictures is still burdened by the mandatory transperitoneal approach and the steep Trendelenburg patient position. Our aim was to describe the largest series of patients treated with single-port robot-assisted ureteral reimplantation (SP-RAUR) via a supine extraperitoneal approach, with a focus on the surgical technique, perioperative surgical outcomes, and functional results.
Methods and surgical procedure
Clinical and surgical data for all consecutive adult patients treated with SP-RAUR between January 2021 and September 2023 were prospectively collected. Patients were stratified by surgical approach into low anterior access (LAA) and transperitoneal (TP) groups. Ureteral reimplantation was performed extraperitoneally with patients in a supine position.
Key findings and limitations
Overall, 20 patients who underwent SP-RAUR and had minimum follow-up of 1 yr were included in the analysis, of whom 50% were treated via an LAA approach. There were no significant differences in baseline characteristics between the groups. No open conversions or intraoperative complications occurred. The operative time was shorter in the LAA group than in the TP group (165 vs 191 min; p = 0.01). In terms of perioperative features, the LAA approach was associated with lower postoperative pain and opioid use and shorter length of stay (8 vs 26.5 h; p = 0.016). No major postoperative complications or recurrent urinary obstruction were observed after median follow-up of 14.5 mo.
Conclusions and clinical implications
SP-RAUR via LAA represents a feasible and safe procedure with potential to improve perioperative recovery for patients with a distal ureter stricture.
Patient summary
We assessed a new robot-assisted surgery technique to treat narrowing of the tube that drains urine from the kidney into the bladder. This technique uses just a single small incision. Our results show that the procedure is safe and that patients have a quick recovery and a fast return to everyday activities. Larger studies with more patients are needed to confirm these results.
1. Introduction
Management of distal ureteral strictures still represents a surgical challenge because of high variability in terms of stricture location, extent, and etiology [1]. Several minimally invasive techniques for both refluxing and nonrefluxing reimplants with perioperative advantages in comparison to the standard open approach have been developed [2]. In particular, multiport (MP) robot-assisted ureteral reimplantation (RAUR) overcomes the laparoscopic limitations of a lack of steadiness and the limited degree of freedom, and provides a three-dimensional magnified view, tremor filtration, and enhanced ergonomics [[3], [4], [5]]. These features allow easy translation of more complex tension-free techniques such as the Psoas hitch (PH) and Boari flap (BF) from the open experience to minimally invasive surgery, with promising preliminary results reported [6,7]. Nevertheless, the wide space for instrument triangulation required by MP systems forces adoption of a transperitoneal (TP) approach with the patient in a steep Trendelenburg position, with potential for issues related to bowel mobilization and adhesions in cases with previous major surgery [8,9].
Against this background, the recent introduction of the da Vinci Single Port (SP) platform (Intuitive Surgical, Sunnyvale, CA, USA) has paved the way to new single-access options owing to the high flexibility of the surgical instruments and the narrow space required for triangulation. Our group has developed a low anterior access (LAA) technique in an attempt to achieve a feasible extraperitoneal approach for upper urinary tract surgery with the patient in a supine position [10]. The feasibility and safety of this technique in the management of distal ureteral disease are still to be determined and there is a lack of studies assessing extraperitoneal RAUR for benign stenosis in the adult population.
To fill this gap, we describe here our step-by-step LAA technique for SP-RAUR and compare its benefits and disadvantages to a series of transperitoneal SP-RAUR procedures.
2. Patients and methods
2.1. Patients and data set
Clinical and surgical data for all consecutive patients who underwent SP-RAUR between January 2021 and September 2023 were prospectively collected in our institutional review board–approved data set. Our analysis only included patients with at least 1 yr of follow-up. All cases were performed in one academic center by a single expert surgeon.
The inclusion criteria were the presence of clinical symptoms such as flank pain and/or recurrent urinary tract infections (UTIs) and evidence of obstruction (ipsilateral hydronephrosis of grade ≥2) at the level of the distal ureter on standard radiological imaging or a nuclear renal scan (when performed). In cases in which ureteral stones were detected with no concomitant stenosis, endoscopic treatment was performed (ureteroscopy with laser lithotripsy). In cases with a history of previous surgery or of anesthesiology concerns due to Trendelenburg positioning, a supine extraperitoneal approach was preferred. In patients with prior ureteral stenting, ureteral rest was considered when inflammation or mucosal edema was suspected. The occurrence of postoperative complications was reported according to the Clavien-Dindo grading system, with major postoperative complications defined as Clavien-Dindo grade ≥3a [11]. All surgeries were performed using a da Vinci SP robotic system by a single highly trained surgeon (more than 1500 MP and 200 SP procedures). Follow-up assessment was performed at 1, 3, 6, 12, and 24 mo after surgery and included blood tests and conventional imaging (ultrasound or computed tomography scan with or without a nuclear renal scan).
2.2. Surgical technique
2.2.1. Patient positioning and port placement
The patient was positioned supine on a flat surgical table configuration. The ipsilateral lower abdominal quadrant was prepared and draped in a sterile manner. A 3-cm skin incision was then performed, intersecting the lateral third of an imaginary line drawn between the umbilicus and the anterior superior iliac spine. When a need for a BF was predicted, the skin incision was carried out more cranially. The soft subcutaneous tissue and anterior abdominal fascia were dissected, and the anterolateral abdominal muscles were bluntly spread. Once the preperitoneal fat was visualized, a Rich retractor was placed deep to the abdominal wall, and a gentle lateral dissection was performed to access the retroperitoneal space, allowing visualization of the anterior superior iliac spine. The SP access port (Intuitive Surgical) was then inserted through the incision and oriented towards the hypogastric region. Pneumoperitoneum of 10 mm Hg was established using an AirSeal system (CONMED, Utica, NY, USA) via a 5-mm trocar from the Fish Ball access kit. The SP platform was docked, with the endoscope positioned at the 6-o’clock position, monopolar curved scissors on the right, Cadiere fenestrated bipolar forceps on the left, and Cadiere forceps at the 12-o’clock position. Flexible suction was managed with the left hand using a remotely operated suction and irrigation system (ROSI; VTI, Nashua, NH, USA; Fig. 1). If this system is unavailable, a Foley catheter or a nasogastric tube can be used as a flexible suction device.
Fig. 1.
Patient positioning and docking phase of for single-port robot-assisted ureteral reimplantation via low anterior access.
2.2.2. Surgical technique
Once access was achieved, the robotic procedure started with dissection of the extraperitoneal space towards the prevesical fat, with the peritoneal reflection forming the medial boundary and the psoas muscle the lateral boundary. During this phase, the medial portion of the external iliac artery and vein was typically visualized and carefully isolated, serving as a key landmark for proper dissection. The anterior bladder wall was then dissected until the pubic bone was exposed (Fig. 2). The ureter was identified at the bifurcation of the common iliac artery and mobilized caudally until the diseased segment was reached and incised. If necessary, the supine patient position allowed quick intraoperative ureteral injection of indocyanine green (ICG) to facilitate ureter identification and intraoperative flexible ureteroscopy (Fig. 3). Then the ureter was spatulated posteriorly and the posterolateral bladder surface was dissected until the detrusor muscle was exposed. A 3-cm longitudinal incision was made at the ipsilateral bladder dome, and a mucosa-to-mucosa anastomosis was performed using a double-armed 4-0 suture in a running fashion. Following closure of the posterior plate of the anastomosis, a double-J stent was inserted in a retrograde manner through the 12-mm access port (Fig. 4). If necessary, a PH was then completed using a 2-0 nonabsorbable suture to ensure a tension-free anastomosis.
Fig. 2.
Anatomic landmarks during first steps of single-port robot-assisted ureteral reimplantation via low anterior access.
Fig. 3.
Intraoperative ureteral injection of indocyanine green to improve ureteral visualization.
Fig. 4.
Double-J stent placement during the reconstructive phase of single-port robot-assisted ureteral reimplantation via low anterior access.
2.3. Statistical analysis
Statistical analysis was performed and reported in accordance with established guidelines [12]. Descriptive statistics were calculated, with the frequency and proportion reported for categorical variables, and the median and interquartile range (IQR) for continuous variables. The significance of differences between the TP and LAA groups was evaluated using the Mann-Whitney U test. Statistical analysis was performed using R version 4.3.2 (R Foundation for Statistical Analysis, Vienna, Austria).
3. Results
Overall, 20 patients who underwent SP-RAUR and had follow-up of at least 1 yr were included in the analysis. Supine extraperitoneal LAA was used in ten of these patients (50%; Table 1). At baseline, the only significant difference between the LAA and TP groups was a higher frequency of previous abdominal surgery in the LAA group (90% vs 40%; p = 0.03). Median age was 51 yr (IQR 35–61) in the LAA group versus 43 yr (IQR 38–58) in the TP group. Median body mass index was 31.1 kg/m2 (IQR 24.9–32.5) in the LAA group versus 34.6 kg/m2 (IQR 24.2–39.6) in the TP group (Table 1). In five cases, double-J stents were removed 3–6 wk before surgery, and urinary diversion with percutaneous nephrostomy was required during the ureteral rest period in two of these. Supplementary Table 1 lists details for stricture etiology and length and results for renal nuclear scans.
Table 1.
Baseline characteristics of patients treated with single-port robot-assisted ureteral reimplantation overall and stratified by surgical approach
| Parameter | Overall (n = 20) |
TPA (n = 10) |
LAA (n = 10) |
p valuea |
|---|---|---|---|---|
| Median age at surgery, yr (IQR) | 45 (38–58) | 43 (39–58) | 51 (35–61) | >0.9 |
| Female, n (%) | 17 (88) | 9 (90) | 8 (80) | >0.9 |
| Median BMI, kg/m2 (IQR) | 33.3 (24.2–35.1) | 34.6 (24.2–39.6) | 31.1 (24.9–32.5) | 0.2 |
| Smoking status, n (%) | 0.2 | |||
| Never | 8 (40) | 4 (40) | 4 (40) | |
| Current | 3 (15) | 1 (10) | 2 (20) | |
| Former | 9 (29) | 5 (50) | 4 (40) | |
| Median CCI (IQR) | 2 (1–3) | 2 (1–3) | 2 (1–3) | 0.5 |
| Hypertension, n (%) | 14 (71) | 6 (60) | 8 (80) | >0.9 |
| Hypercholesterolemia, n (%) | 10 (50) | 7 (70) | 3 (30) | 0.3 |
| COPD, n (%) | 8 (40) | 5 (50) | 3 (30) | 0.3 |
| Diabetes, n (%) | 2 (10) | 1 (10) | 1 (10) | >0.9 |
| Obesity, n (%) | 10 (50) | 6 (60) | 4 (40) | 0.13 |
| Median CKD stage (IQR) | 2 (1–3) | 2 (1–3) | 2 (1–3) | 0.9 |
| Median ASA score (IQR) | 2 (2–3) | 2 (2–3) | 2 (2–3) | 0.9 |
| Previous abdominal surgery, n (%) | 15 (75) | 5 (50) | 9 (90) | 0.03 |
| Median PrSC, mg/dl (IQR) | ||||
| Before PTUD | 1.85 (1.36–2.11) | 1.77 (1.23–2.12) | 1.96 (1.34–2.23) | 0.5 |
| After PTUD | 1.02 (0.76–1.41) | 1.13 (1.00–1.41) | 0.80 (0.74–1.02) | 0.14 |
| mP-eGFR, ml/min/1.73 m2 (IQR) | ||||
| Before PTUD | 39 (25–52) | 44 (28–58) | 34 (21–47) | 0.4 |
| After PTUD | 80 (45–97) | 76 (45–87) | 94.5 (80–99) | 0.2 |
| Preoperative DNRS, n (%) | ||||
| Performed | 12 (60) | 7 (70) | 5 (50) | 0.7 |
| Not performed | 8 (40) | 3 (30) | 5 (50) | |
| Postoperative DNRS, n (%) | ||||
| Performed | 14 (70) | 6 (70) | 6 (70) | 0.7 |
| Not performed | 6 (30) | 4 (30) | 4 (30) | |
| Cause of stricture, n (%) | 0.2 | |||
| Iatrogenic | 15 (75) | 7 (70) | 8 (80) | |
| Trauma | 5 (25) | 3 (30) | 2 (20) | |
| Hydronephrosis grade, n (%) | >0.9 | |||
| Grade 2 | 1 (5) | 1 (10) | 0 (0) | |
| Grade 3 | 19 (95) | 9 (90) | 10 (100) | |
| Side affected, n (%) | 0.3 | |||
| Right | 13 (65) | 6 (60) | 7 (70) | |
| Left | 7 (35) | 4 (40) | 3 (30) | |
| Symptoms, n (%) | >0.9 | |||
| Flank pain alone | 7 (35) | 4 (40) | 3 (30) | |
| Urinary tract infection | 13 (65) | 6 (60) | 7 (70) | |
| Type of PTUD, n (%) | 0.6 | |||
| Double-J stent/NephroU | 13 (65) | 8 (80) | 5 (50) | |
| Nephrostomy | 7 (35) | 2 (20) | 5 (50) | |
| Ureteral rest, n (%) | 5 (20) | 3 (30) | 2 (20) | |
ASA = American Society of Anesthesiologists; BMI = body mass index; CCI = Charlson comorbidity index; CKD = chronic kidney disease; COPD = chronic obstructive pulmonary disease; DNRS = dynamic nuclear renal scan; IQR = interquartile range; LAA = low anterior access; mP-eGFR = median preoperative estimated glomerular filtration rate; PrSC = preoperative serum creatinine; PTUD = preoperative temporary urinary diversion; TPA = transperitoneal access.
Wilcoxon rank-sum test, Fisher’s exact test, or Wilcoxon rank-sum exact test, as appropriate.
The LAA group had significantly shorter operative time (165 vs 191 min; p = 0.013) and nonsurgical operative room time (37 vs 49 min; p = 0.022) and significantly lower estimated blood loss (30 vs 108 cm3; p = 0.002; Table 2). For pain management, the LAA procedure was associated with significantly lower intraoperative and postoperative opioid use (p = 0.001) and a significantly lower transfusion rate (p = 0.01). Median length of hospital stay (LOS) was 8 h in the LAA group versus 26.5 h in the TP group (p = 0.016), with a same-day discharge (SDD) rate of 90% in the LAA group. Overall, postoperative complications occurred in three patients in the LAA group (two UTIs treated with antibiotics and one early catheter displacement) with no major complications (Table 3). The median time to catheter removal was 7 d (IQR 6–14) and the ureteral stent was removed after a median of 38 d. No recurrence of urinary obstruction was observed in the LAA group up to median follow-up of 14.5 mo.
Table 2.
Intraoperative and early postoperative outcomes for patients treated with single-port robot-assisted ureteral reimplantation overall and stratified by surgical approach
| Characteristic | Overall (n = 20) |
TPA (n = 10) |
LAA (n = 10) |
p valuea |
|---|---|---|---|---|
| Median OT, min (IQR) | 185 (165–192) | 191 (185–210) | 165 (148–178) | 0.013 |
| Non-surgical operative room time (min), median (IQR) | 45(36–52) | 49 (45–57) | 37 (16–41) | 0.022 |
| Median EBL, cm3 (IQR) | 74 (30–100) | 108 (30–150) | 30 (20–40) | 0.002 |
| Intraoperaive opioid use (mg), median (IQR) | 9 (2–15) | 15 (10–20) | 4 (2–8) | 0.001 |
| Transfusion, n (%) | 2 (10) | 2 (20) | 0 (0) | 0.01 |
| Surgical procedure, n (%) | 0.3 | |||
| Direct reimplantation alone | 6 (30) | 3 (30) | 3 (30) | |
| Psoas Hitch | 12 (60) | 6 (60) | 6 (60) | |
| Boari Flap | 2 (10) | 1 (10) | 1 (10) | |
| Intraoperative complications, n (%) | 0 (0) | 0 (0) | 0 (0) | 0.9 |
| Open conversion, n (%) | 0 (0) | 0 (0) | 0 (0) | 0.9 |
| Drain placement, n (%) | 6 (30) | 6 (60) | 0 (0) | 0.01 |
| Median LOS, h (IQR) | 10 (8–27) | 26.5 (11–37) | 8 (7–9) | 0.016 |
| SDD, n (%) | 11 (55) | 2 (20) | 9 (90) | 0.002 |
| Postoperative pain score (2h-VAS), median (IQR) | 4 (2–8) | 6 (4–8) | 2 (1–4) | 0.003 |
| Opioid use POD 0 (TME mg), median (IQR) | 15 (8–20) | 25 (15–40) | 10 (0–15) | 0.001 |
| Opioid use - cumulative admission-discharge (TME mg) | 27 (10–40) | 40 (20–45) | 15 (4–20) | 0.001 |
IQR = interquartile range; EBL = estimated blood loss; LAA = low anterior access; LOS = length of stay; OT = operative time; SDD = same-day discharge; PTUD = preoperative temporary urinary diversion; TPA = transperitoneal access.
Wilcoxon rank-sum test or Fisher’s exact test, as appropriate.
Table 3.
Postoperative outcomes for patients treated with single-port robot-assisted ureteral reimplantation overall and stratified by surgical approach
| Parameter | Overall N = 201 |
TPA (n = 10) |
LAA (n = 10) |
p valuea |
|---|---|---|---|---|
| PO complications, n (%) | 9 (45) | 6 (60) | 3 (30) | 0.13 |
| Overall | ||||
| By Clavien-Dindo grade | 0.3 | |||
| Grade ≤2 | 4 (20) | 4 (40) | 3 (30) | |
| Grade ≥3a | 2 (10) | 2 (20) | 0 (0) | |
| Radiologic RoH, n (%) | 0.6 | |||
| No | 12 (60) | 5 (50) | 7 (70) | |
| Yes | 8 (40) | 5 (50) | 3 (30) | |
| Symptom resolution, n (%) | >0.9 | |||
| No | 1 (5) | 1 (10) | 0 (0) | |
| Yes | 19 (95) | 9 (90) | 10 (100) | |
| Median SC, mg/dl (IQR) | ||||
| Postoperative | 0.85 (0.67–0.97) | 0.81 (0.65–1.07) | 0.87 (0.68–0.95) | >0.9 |
| Last measurement | 0.87 (0.68–1.02) | 0.83 (0.65–1.12) | 0.91 (0.71–1.02) | 0.9 |
| Median eGFR, ml/min/1.73 m2 (IQR) | ||||
| Postoperative | 95 (82.5–102.5) | 95.5 (62–105) | 93.5 (91–100) | >0.9 |
| Last measurement | 92 (82–101.5) | 92 (72–105) | 92 (83–96) | >0.9 |
| Median TSR, d (IQR) | 30 (21–45) | 35 (21–40) | 38 (30–45) | >0.9 |
| UO recurrence, n (%) | 1 (5) | 1 (10) | 0 (0) | 0.7 |
| Median follow-up, mo (IQR) | 17 (6–24) | 21 (6–26) | 14.5 (12–18) | 0.3 |
eGFR = estimated glomerular filtration rate; LAA = low anterior access; PO = postoperative; RoH = resolution of hydronephrosis; SC = serum creatinine; TPA = transperitoneal access; TSR = time to stent removal; UO = urinary obstruction.
Fisher’s exact test or Wilcoxon rank-sum test, as appropriate.
4. Discussion
Progressive adoption of minimally invasive surgery worldwide has greatly influenced the management of several urological conditions, with optimization of perioperative patient care [13]. In this context, MP-RAUR provides several benefits over open surgery, such as shorter LOS and stent duration and lower estimated blood loss [2]. These advantages mean that eligibility for reconstructive procedures could be extended to patients with multiple comorbidities [14]. Nevertheless, the intrinsic features of MP platforms shifted surgical preference from a retroperitoneal to a transperitoneal approach, for which the mandatory Trendelenburg position and a patient history of previous major abdominal surgery might jeopardize surgical feasibility and safety [15,16]. In addition, high variability for the extent and location of ureteral strictures still represents a surgical challenge, especially considering the low flexibility of the standard MP transperitoneal approach that requires different patient positions and redocking in cases of synchronous upper-tract strictures. Against this background, our study provides a step-by-step description of SP-RAUR via LAA in an attempt to retain the benefits of robot-assisted surgery with a flexible supine retroperitoneal approach that allows easy management of both proximal and distal ureteral strictures [9,10].
To the best of our knowledge, our study represents the first series focused on extraperitoneal SP-RAUR for benign stenosis in the adult population that also provides a comparison to transperitoneal SP-RAUR.
The first key finding from our study is that SP-RAUR via LAA is a feasible and reliable surgical option for the management of benign distal ureteral strictures in the adult population, including challenging cases. Even though 90% of patients in the LAA group had a history of major abdominal surgery, the overall operative time was significantly shorter in the LAA group than in the TP group (p = 0.013). The extraperitoneal approach allowed direct access to the surgical target and thus avoided extensive adhesiolysis. Moreover, in cases in which ureter or stricture identification is difficult, the supine position facilitates adoption of combined endourological procedures, with easy operative access to the bladder to perform flexible ureteroscopy or ureteral ICG injection. To date, acknowledging the lack of MP comparison in our analysis, our preliminary perioperative results are highly consistent with the literature. Buffi et al [6] reported outcomes for a large multicenter cohort of 183 patients who underwent MP ureteral repair for ureteropelvic junction obstruction or proximal or distal ureteral strictures. In the RAUR subgroup the median operative time was 165 min and there were no intraoperative complications or conversion to open surgery. Dell’Oglio et al [7] analyzed 37 patients requiring complex robot-assisted ureteral reconstructions via a BF and/or PH for which the median operative time was 180 min. In our study, a complex ureteral reimplantation was performed in 70% of patients in the LAA group, for which the median operative time was 165 min and there were no intraoperative complications or conversions to open surgery. These results highlight the reproducibility of SP-RAUR via LAA and the achievement of good perioperative outcomes during the first steps of the learning curve for this technique.
Second, LAA was associated with enhanced postoperative recovery, with median LOS of 8 h, significantly lower postoperative pain and opioid requirements, and a high SDD rate of 90%. These results may be attributable to a beneficial effect of a “regionalized” surgical approach on patient recovery, with minimization of tissue dissection and avoidance of anesthesiology issues related to a steep Trendelenburg position. A growing body of evidence over recent years has documented the reduction of surgical impact on patient recovery in supine extraperitoneal SP procedures. A meta-analysis by Li et al [17] revealed a significant reduction in LOS and opioid use with SP robot-assisted radical prostatectomy in comparison to MP surgery. Similarly, a comparative systematic review of upper-tract procedures by Shi et al [18] revealed a better perioperative course with supine extraperitoneal pyeloplasty. Our results further support the benefits of the LAA approach, particularly in the context of reconstructive surgery.
Third, postoperative complication and functional results demonstrated the success of the LAA SP-RAUR procedure, with no major complications or recurrent urinary obstruction up to median follow-up of 14.5 mo. Careful and precise management of the vesicoureteral anastomosis via the robot-assisted approach resulted in effective functional outcomes that are consistent with most MP-RAUR reports [2].
Given the preliminary nature of our study, we acknowledge several limitations. First, the limited sample size and the retrospective design might have introduced non-negligible bias in the final analysis, and a precise representation of the flowchart for patient selection was not possible. Second, all cases were performed by an expert SP surgeon with a consolidated background in MP surgery, which limits the generalizability of the results. In this light, further studies with a larger sample size and greater surgeon heterogeneity are still warranted also to assess the learning curve for RAUR via LAA. Finally, lack of direct comparison with multiport group might reduce the strength of the clinical message provided.
5. Conclusions
SP-RAUR via LAA represents a feasible and safe procedure with potential to improve the perioperative recovery. Larger series with longer follow-up are needed to confirm our preliminary results.
Author contributions: Luca Lambertini had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.
Study concept and design: Lambertini, Crivellaro.
Acquisition of data: Avesani, Sauer Calvo, Torres Angugliano.
Analysis and interpretation of data: Haberal.
Drafting of the manuscript: Lambertini.
Critical revision of the manuscript for important intellectual content: Crivellaro.
Statistical analysis: Morgantini.
Obtaining funding: None.
Administrative, technical, or material support: None.
Supervision: Crivellaro, Minervini.
Other: None.
Financial disclosures: Luca Lambertini certifies that all conflicts of interest, including specific financial interests and relationships and affiliations relevant to the subject matter or materials discussed in the manuscript (eg, employment/affiliation, grants or funding, consultancies, honoraria, stock ownership or options, expert testimony, royalties, or patents filed, received, or pending), are the following: None.
Funding/Support and role of the sponsor: None.
Data sharing statement: The data sets generated and/or analyzed during the current study are available from the corresponding author on reasonable request.
Ethics considerations: All procedures performed in this study involving human participants were in accordance with the ethical standards of institutional and national research committees and with the 1964 Declaration of Helsinki and its later amendments, or comparable ethical standards.
Associate Editor: Véronique Phé
Footnotes
Supplementary data to this article can be found online at https://doi.org/10.1016/j.euros.2025.06.002.
Appendix A. Supplementary data
The following are the Supplementary data to this article:
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