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ORIGINAL ARTICLE
Year : 2023 | Volume
: 34
| Issue : 2 | Page : 99-106
Comparison between two da vinci surgical systems in trifecta and pentafecta rates for robot-assisted partial nephrectomy
Chih-Heng Chen1, Kuo-How Huang1, Shuo-Meng Wang1, Po-Ming Chow1, Pei-Ling Chen1, Jian-Hua Hong2, Chao-Yuan Huang1
1 Department of Urology, National Taiwan University Hospital, National Taiwan University, College of Medicine, Taipei, Taiwan
2 Department of Urology, National Taiwan University Hospital, National Taiwan University, College of Medicine; Institute of Biomedical Engineering, National Taiwan University, Taipei, Taiwan
Correspondence Address:
Chao-Yuan Huang
No. 7, Chung-Shan South Road, Zhongzheng District, Taipei 100
Taiwan
Jian-Hua Hong
No. 7, Chung-Shan South Road, Zhongzheng District, Taipei 100
Taiwan
Source of Support: None, Conflict of Interest: None
DOI: 10.4103/UROS.UROS_172_21
Purpose: Comparative studies on the outcomes of robot-assisted partial nephrectomy (RAPN) procedures conducted using the da Vinci Xi and Si platforms remain sparse. We retrospectively reviewed and compared the Trifecta and Pentafecta rates of the two robotic surgical platforms. Materials and Methods: A total of 338 patients who had undergone RAPN using da Vinci Si platform or Xi platform were included. Pentafecta was defined herein as Trifecta (a warm ischemia time <25 min, a negative surgical margin, and the absence of significant perioperative complications) with the addition of estimated glomerular filtration rate preservation of over 90% and no chronic kidney disease stage progression by 12 months postsurgery. Multivariate logistic regression analysis was conducted to identify the predictors of Trifecta and Pentafecta achievement. Results: The trifecta and pentafecta rates were higher in the Xi group than in the Si group (65% vs. 29%, P < 0.001 for trifecta; 31% vs. 14%, P = 0.001 for pentafecta). In addition, a significantly shorter average WIT (19 vs. 28 min, P < 0.001) and console time (141 vs. 163 min, P = 0.004) were identified in the Xi group than in the Si group. RAPN conducted using the Xi platform was independently associated with both higher achievement rates of trifecta and pentafecta. In addition, multivariate regression analyses revealed that no history of hypertension, low tumor complexity as measured using the RENAL nephrometry score, anterior orientation of the renal tumor were associated with higher Trifecta rates; while history of diabetes and anterior–posterior renal tumor orientation were the significant predictors of Pentafecta achievement, respectively. Conclusion: A significantly higher rates of trifecta and pentafecta achievement were observed in the Xi group than in the Si group. The use of the Xi platform was also significantly associated with low operative times and acceptable complication rates.
Keywords: Da Vinci Si, da Vinci Xi, robotic-assisted partial nephrectomy, trifecta and pentafecta
Partial nephrectomy (PN) is the treatment of choice for small and large renal tumors, if feasible. Even when used for the treatment of large localized renal tumors (≥7 cm), PN has exhibited oncological outcomes and complication rates comparable to those of radical nephrectomy. Its benefits have been highlighted, and its utilization has dramatically increased in the early 2000s.[1],[2],[3]
Conventionally, PN is performed using an open (OPN) or laparoscopic (LPN) approach. With the advancement of robotic technology, robot-assisted laparoscopic PN (RAPN) has been developed, which overcomes the shortcomings of OPN and LPN and has become the most feasible option in nephron-sparing surgery. RAPN results in shorter warm ischemia times (WITs), lower perioperative complication rates, lower blood loss, shorter hospital stay, and lesser renal function impairment postoperatively compared with OPN and LPN.[4],[5],[6] Chang et al. observed that RPN, OPN, and LPN exhibited comparable oncological outcomes, including local recurrence, distant metastasis, and cancer-specific death rate, at the 5-year median follow-up.[4],[5],[6] Based on these favorable results, RAPN has become the preferred approach for localized renal tumors.
Currently, the da Vinci surgical system (Intuitive Surgical Inc., Sunnyvale, CA, USA) is the dominantly approved robot-assisted surgery system used. Improvements have been made in the da Vinci surgical system in the past decades from the release of S and Si systems to that of the latest design, the Xi system. The fourth-generation da Vinci surgical system, the Xi platform, was introduced in 2014 and has been used in several complicated surgeries.[7],[8],[9],[10],[11],[12],[13] In contrast to the previous robot-assisted surgery systems, the da Vinci Xi system incorporates advancements such as a redesigned boom-mounted system and laser-guided docking assistance, reducing the technical difficulties associated with docking, targeting, and performing surgical procedures. Studies have compared the Xi system with the Si system for urologic and nonurologic surgeries. Most of these studies have focused on perioperative reports, including declined anesthesia and total operative and docking times.[7],[8],[9],[10],[11],[12],[13] Functional outcomes, complications, and oncologic outcomes following PN are key endpoints for evaluating the functionality of RAPN systems.[14] However, only a few previous studies have compared the short- and mid-term oncologic outcomes of RAPN procedures using the da Vinci Xi and Si platforms with limited sample sizes.[7] Furthermore, no study has evaluated the effects of different da Vinci surgical systems on Trifecta or Pentafecta rates. Therefore, this study compared the Trifecta and Pentafecta rates of patients who underwent RAPN using the da Vinci Xi or Si platforms at one tertiary referral institution.
Materials and MethodsThis study was approved by the institutional review board of National Taiwan University Hospital (approval number 201305059RINC). The informed consent requirement was waived due to the retrospective design of our study. The electronic medical records of patients who underwent RAPN were retrospectively reviewed using the da Vinci Xi or Si systems at our institute between April 1, 2012, and August 31, 2019. Four experienced laparoscopic surgeons performed all RAPNs. Considering the initial learning curve for RAPN, the first five RAPNs performed by each surgeon were excluded.[15],[16] Patients with histories of combined laparoscopic surgery and bilateral RAPN who had incomplete data or were aged <18 years were excluded. The follow-up data were collected on September 1, 2020. The basic characteristics of patients, including comorbidities, preoperative serum creatinine levels, estimated glomerular filtration rate (eGFR), and RENAL nephrometry score,[17] were collected. We also obtained patients' peri- and postoperative outcomes, namely, docking time, WIT, console time, total operative time, estimated blood loss, pathological findings, complications graded based on the Clavien –Dindo classification,[18] length of hospital stay, and renal function at 1, 6, and 12 months postoperatively. Trifecta and Pentafecta rates were used to evaluate the surgical quality. Herein, Trifecta was defined as WIT of <25 min, a negative surgical margin, and the absence of complications of Grade II or higher based on the Clavien–Dindo classification.[19] Pentafecta was defined as Trifecta with additional eGFR preservation of >90% and no chronic kidney disease stage progression by 12 months postoperatively.[20]
Operative techniques
In both transperitoneal and retroperitoneal approaches to RAPNs performed using the da Vinci Si or Xi system, the patient is placed under general anesthesia and in the lateral position with the operative side up. The table is then flexed to extend the area between the patient's subcostal margin and iliac crest. All pressure points of the patient are protected by pads, and the patient is fixed to the surgical table using adhesive tape.
After positioning the patient, the abdomen is prepared and draped in a sterile manner. Under mini-laparotomy or Visiport (Covidien Healthcare, USA) guidance, a 12-mm camera port is placed lateral to the rectus abdominis muscle and umbilicus. Pneumoperitoneum is created at a pressure of 15 mmHg. [Figure 1] illustrates the port configuration. The first 8-mm robotic port is inserted at approximately 7 cm lateral and cranial to the camera port and approximately 2 cm below the subcostal margin. The second 8-mm robotic port is placed approximately 7 cm lateral and caudal to the camera port. The third 8-mm robotic port is inserted approximately 7 cm lateral and cranial to the second 8-mm port. A 12-mm assistant port is placed medial and cranial to the camera port, forming a triangle between the first 8-mm port and camera port. The robot is then docked close to the back of the patient and perpendicular to the craniocaudal axis. The procedures performed using the robotic surgical platform comprise dissection of the white line of Toldt, ureter, and gonadal vein to the renal hilum and renal vessel identification. A laparoscopic ultrasound probe is used if the tumor margin is not easily identified. An assistant used laparoscopic Bulldog clamp clips to temporarily block the renal arteries. Some of the selected tumors, especially small and exophytic lesions, may be resected without hilar clamping. The tumor is then enucleated or enucleo-resected using cold scissors. The collecting system and renal parenchyma are repaired by double-layer closure using 3-0 V-Loc sutures. At postrenorrhaphy, renal arteries are unclamped, and the suture site is carefully inspected. Hemostatic materials, such as Surgicel (Ethicon Inc., Somerville, NJ, USA), Floseal (Baxter Healthcare Inc., Fremont, CA, USA), or Tisseel (Baxter Healthcare Inc., Fremont, CA, USA), may be used as per the surgeon's preference. Finally, the specimen is placed in an Endo Catch bag and retrieved from the camera port.
Figure 1: Port placement for RAPN (left side). RAPN: Robot-assisted partial nephrectomyStatistical analysis
All statistical analyses were performed using SPSS version 26 (IBM, SPSS, Chicago, IL, USA). Continuous variables were analyzed using a Mann–Whitney U test, and categorical variables were analyzed using a Chi-squared test and Fisher's exact test. Factors such as age, gender, body mass index (BMI), hypertension (HTN), diabetes mellitus (DM), coronary artery disease, chronic kidney disease, eGFR, tumor site, RENAL nephrometry score, surgeon RAPN number, and type of da Vinci system were analyzed through univariate logistic regression to identify predictors of Trifecta and Pentafecta achievement [Table S1]. Factors with a P value of <0.05 in univariate logistic regression were included in multivariate analysis to identify independent predictors. A two-tailed P value of < 0.05 was considered statistically significant in all patients.
Medical records of 384 patients who underwent RAPN at our institute were retrospectively reviewed. Among them, 9 who underwent combined laparoscopic surgery, 2 who underwent bilateral RAPN, and 35 who had incomplete postoperative follow-up data were excluded. A total of 338 patients were enrolled, comprising 226 and 112 patients who underwent RAPN using the da Vinci Si and Xi platforms, respectively. [Table 1] lists the baseline characteristics of the cohort. There were no significant differences in the patient and tumor features, including age, sex, BMI, comorbidities, tumor laterality, tumor size, RENAL score risk classification, and anteroposterior tumor location, between the Si and Xi groups.
Table 1: Baseline characteristics and histopathological data of enrolled patients[Table 2] presents peri- and postoperative outcomes. The Xi group exhibited a significantly shorter average WIT (19 vs. 28 min, P < 0.001) and console time [141 vs. 163 min, P = 0.004; [Figure 2]] than the Si group. There were no obvious differences in docking and total operative times between the Xi and Si groups. Regarding postoperative outcomes, Trifecta and Pentafecta rates were significantly higher in the Xi group than in the Si group, with Trifecta rates of 65% and 29% (P < 0.001) and Pentafecta rates of 31% and 14% in the Xi and Si groups, respectively (P = 0.001). However, there were no obvious differences in the estimated blood loss, perioperative blood transfusion, complication rate, length of hospital stay, and postoperative eGFR loss between the two groups.
Figure 2: Box plot illustrating comparisons of RAPN surgical times between the da Vinci Si and Xi surgical groups. (a) Docking time, (b) warm ischemic time, (c) console time, (d) total operative time. Data were displayed based on the median, the first and third quartiles. Dots denoted outliers. RAPN: Robot-assisted partial nephrectomyMoreover, we assessed the learning curves of RAPN using the Si and Xi systems [Figure 3]. Both Si and Xi groups exhibited shorter console time and WIT as the number of RAPN procedures conducted by the surgeons increased. Among the first 50 procedures conducted, the average WIT and console time were shorter in the Xi group than in the Si group, regardless of the RENAL score classification of the tumors.
Figure 3: (a) Console time of RENAL score ≥7 tumors, (b) console time of RENAL score <7 tumors, (c) warm ischemia time of RENAL score ≥7 tumors, (d) warm ischemia time of RENAL score <7 tumors[Table 3] displays the multivariate logistic regression models for Trifecta and Pentafecta achievement. Independent predictors of Trifecta achievement were a history of HTN, RENAL score risk classification, anteroposterior renal tumor orientation, and the da Vinci system used. Patients with DM, who had a posterior renal tumor, or who underwent RAPN using the da Vinci Si system were less likely to achieve Pentafecta. However, HTN history and RENAL score risk classification were not significantly associated with Pentafecta achievement.
Table 3: Multivariate logistic regression analyses of Trifecta and Pentafecta achievement rates Discussion This study recruited patients who underwent RAPN using the da Vinci Si or Xi system and found that those who used the Xi system exhibited significantly higher Trifecta and Pentafecta rates than those who used the Si system. Furthermore, RAPN performed using the Xi platform involved a significantly shorter average WIT and console time than those using the Si platform, although the complication rates of these platforms were similar. Multivariate regression analyses revealed that no history of HTN, low tumor complexity measured using the RENAL nephrometry score, the anterior orientation of the renal tumor, and RAPN performed using the Xi platform was associated with higher Trifecta rates. Moreover, the history of DM, anteroposterior renal tumor orientation, and RAPN performed using the da Vinci surgical platform were the significant predictors of Pentafecta achievement. These results indicate that the Xi system is more feasible for performing RAPN in patients with renal tumors.
Studies comparing different generations of da Vinci surgical platforms for RAPN have remained scarce with limited comparative data. Kallingal et al. reported their experiences of 15 patients who underwent RAPN using the da Vinci Xi system. They reported that the Xi system could be used to safely perform RAPN, with tolerable pathological and perioperative outcomes.[21] A preliminary study by Abdel Raheem et al. examined 18 patients who underwent RAPN using the Xi platform and randomly selected 18 patients using the Si platform as the control group.[7] The average docking time and similar postoperative complications were significantly shorter in the Xi group than in the Si group. Although the Xi group also exhibited a shorter WIT and higher Trifecta rate, these differences were statistically nonsignificant, perhaps due to the small sample size. To date, this is the largest study to demonstrate that RAPN procedures performed using the da Vinci Xi platform involve lower average WITs, shorter console times, and significantly higher Trifecta and Pentafecta rates than those performed using the Si platform.
Most of the Trifecta and Pentafecta outcomes have focused on assessing the standardized outcomes of RAPN. Identifying the Trifecta and Pentafecta achievement predictors is key to improving peri- and postoperative outcomes. Most studies have concluded that the tumor size and RENAL nephrometry score are the key predictors of Trifecta and Pentafecta achievement. Other factors, such as HTN, preoperative renal function, total operative time, estimated blood loss, surgeon's experience, and hospital volume, had also been reported as independent variables impacting the Trifecta and Pentafecta rates; however, results assessing these factors in previous studies were heterogeneous.[14],[22],[23],[24] In this study, Trifecta and Pentafecta rates in patients with RAPN were influenced by tumor-, surgeon-, and surgical instrument-related factors. These findings are consistent with those of previous studies that the RENAL nephrometry score independently influenced the Trifecta and Pentafecta achievement using the multivariate regression models. In addition to the RENAL nephrometry score, other baselines and prognostic factors were used in the logistic regression to explore potential factors affecting the Trifecta and Pentafecta rates. After adjusting the multivariate logistic regression, utilization of the da Vinci Xi system for RAPN was still significantly associated with high Trifecta and Pentafecta rates. Favorable outcomes of the RAPN performed using the da Vinci Xi system may be attributed to the rapid technological enhancement and the superior design of the new system. Docking is simplified by the new laser-guided assistance characteristic. The redesigned 8-mm laparoscope with higher imaging resolution and the autofocus system can be inserted into any robotic port. Furthermore, an improved design of the boom-mounted system facilitates docking and prevents internal and external collisions of the robotic arms intraoperatively. Based on our surgical team's experience, reduction of the external and internal collisions of robotic arms and assistant port is the main advantage of the da Vinci Xi surgical system over the Si system. This advantage of the Xi system improves fluency and speeds up the surgical process, especially the critical steps during PN, which may all contribute to the reduced warm ischemic and console times.
The technological advancement of the robotic system has not only improved surgical outcomes but also shortened the PN learning curve. Studies reported that the learning curve for RAPN is steeper than those for LPN or OPN.[25],[26],[27] Nevertheless, RAPN results in a shorter WIT and total operative time and greater renal function preservation compared with LPN.[27] This study found that various versions of the da Vinci system exhibit different learning curves. Regardless of RENAL scores, the first few RAPN procedures performed by the surgeon using the Xi system involved a lower WIT and console time than those performed using the Si system, although these differences decreased as the number of RAPN procedures increased [Figure 3].
In the Xi system for RAPN, various port placement arrangements can be used to facilitate docking. Kallingal et al. placed the ports in the linear arrangement at the lateral border of the rectus muscle, which minimized arm collision and increased the fourth arm functionality compared with the conventional port placement in the Si system.[21] Abdel Raheem et al. described a modified linear port placement that significantly reduced the console time in patients with low BMI.[7] Lee et al. used the Xi system for robot-assisted laparoendoscopic single-site PN (R-LESS PN) and demonstrated that R-LESS PN is feasible and safe for selected patients.[28] Despite the consistent and conventional port configuration used in both Xi and Si groups in our study, the Xi system still exerted a positive effect on patients' peri- and postoperative outcomes.
Studies have explored the outcomes of patients with complex renal tumors treated with RAPN. Buffi et al. reviewed the records of 255 patients with highly complex renal tumors (those with a Padua prediction score of 10–14) who underwent RAPN using the da Vinci Si or Xi system at four high-volume tertiary care centers. Among the patients, 5.1% exhibited complications of Clavien–Dindo grade II or higher, and 1.4% exhibited a positive surgical margin.[29] Optimal surgical outcomes, defined similarly to Trifecta outcomes in this study (a negative surgical margin, WIT of <20 min, and absence of complications with Clavien–Dindo of grade ≥ II), were achieved in 62% of patients. In multivariable logistic regression models, extreme tumor complexity (a Padua score of 12–13) was associated with a significantly higher risk of not achieving the optimal outcomes. Similarly, Yim et al. analyzed the records of 157 patients with clinical T3a renal masses and a mean RENAL nephrometry score of 9 who underwent RAPN. The study sample exhibited an acceptable major complication rate, with 4.5% of patients exhibiting complications with Clavien–Dindo of grades III–V, a slightly higher positive surgical margin rate, and higher Trifecta (64.3%) and Pentafecta (37.6%) outcome rates.[30] The results of this study revealed the beneficial effects of the Xi platform for RAPN in patients with low- and intermediate-complexity tumors. However, outcomes in patients with high-complexity tumors in the da Vinci Xi group were similar to those in the Si group, and Trifecta and Pentafecta rates of patients in both groups were lower than those with low- or intermediate-complexity tumors. This may be due to the small number of patients with high-complexity renal tumors in our study. Additional large-scale prospective randomized studies are required to compare the effects of different da Vinci systems on the treatment of high-complexity renal tumors.
This study has some strengths. To the best of our knowledge, this is the largest study to date to compare the outcomes of RAPN procedures performed using the da Vinci Si and Xi systems. Predictors of Trifecta and Pentafecta outcomes were identified using multivariate logistic regression models and verified that using the Xi surgical system was associated with higher Trifecta and Pentafecta rates. Furthermore, the learning curves of Si and Xi surgical systems and their effects on the treatment of renal tumors of different complexities were investigated. However, several limitations are inevitable. First, although our results were based on data collected from a prospective database, analyses were retrospectively performed and may have been confounded by the selection bias. Second, RAPN procedures analyzed in this study were performed by four surgeons with different years of experience. These results may have been influenced by different surgical techniques. Although the univariate logistic regression revealed that Trifecta and Pentafecta achievement was not significantly associated with surgeon's experience, other detailed surgeon-related factors, such as renal hilum control, tumor resection methods, and utilization of early unclamping technique, could not be evaluated in this study. Third, other confounding factors, including the patient's performance status and visceral fat thickness, may have also influenced our outcome interpretation. Despite these limitations, this is the largest study on RAPN conducted to date, and the results demonstrated that the utilization of different da Vinci surgical systems significantly influences Trifecta and Pentafecta rates.
ConclusionPatients who underwent RAPN using the da Vinci Xi platform exhibited higher Trifecta and Pentafecta rates than those who underwent RAPN using the Si platform. Furthermore, procedures conducted using the Xi platform involved a shorter WIT and console time than those conducted using the Si platform, although the complication rates were similar between the two groups. Further prospective multi-institutional randomized controlled trials are required to elucidate the effects of the da Vinci Xi platform on patient outcomes.
Data availability statement
All data generated or analyzed during this study are included in this published article.
Financial support and sponsorship
Nil.
Conflicts of interest
Prof. Chao-Yuan Huang, an editorial board member at Urological Science, had no role in the peer review process of or decision to publish this article. The other authors declared no conflicts of interest in writing this paper.
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