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| Can preoperative planning using IRIS™ three-dimensional anatomical virtual models predict operative findings during robot-assisted partial nephrectomy? |
Ahmed Ghazia,Nitin Sharmaa,*( ),Ahmed Radwanb,Hani Rashida,Thomas Osinskia,Thomas Fryea,William Tabayoyonga,Jonathan Blooma,Jean Josepha
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aUniversity of Rochester, Urology Department, Rochester, NY, USA
bAin Shams University, Urology Department, Cairo, Egypt |
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Abstract Objective: To evaluate the predictive validity of IRIS™ (Intuitive Surgical®, Sunnyvale, CA, USA) as a planning tool for robot-assisted partial nephrectomy (RAPN) by assessing the degree of overlap with intraoperative execution. Methods: Thirty-one patients scheduled for RAPN by four experienced urologists were enrolled in a prospective study. Prior to surgery, urologists reviewed the IRIS™ three-dimensional model on an iphone Operating System (iOS) app and completed a questionnaire outlining their surgical plan including surgical approach, and ischemia technique as well as confidence in executing this plan. Postoperatively, questionnaires assessing the procedural approach, clinical utility, efficiency, and effectiveness of IRIS™ were completed. The degree of overlap between the preoperative and intraoperative questionnaires and between the planned approach and actual execution of the procedure was analyzed. Questionnaires were answered on a 5-point Likert scale and scores of 4 or greater were considered positive. Results: Mean age was 65.1 years with a mean tumor size of 27.7 mm (interquartile range 17.5-44.0 mm). Hilar tumors consisted of 32.3%; 48.4% of patients had R.E.N.A.L. nephrometry scores of 7-9. On preoperative questionnaires, the surgeons reported that in 67.7% cases they were confident that they can perform the procedure successfully, and on intraoperative questionnaires, the surgeons reported that in 96.8% cases IRIS™ helped achieve good spatial sensation of the anatomy. There was a high degree of overlap between preoperative and intraoperative questionnaires for the surgical approach, interpreting anatomical details and clinical utility. When comparing plans for selective or off-clamp, the preoperative plan was executed in 90.0% of cases intraoperatively. Conclusion: A high degree of overlap between the preoperative surgical approach and intraoperative RAPN execution was found using IRIS™. This is the first study to evaluate the predictive accuracy of IRIS™ during RAPN by comparing preoperative plan and intraoperative execution.
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Received: 18 July 2022
Available online: 20 October 2023
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Corresponding Authors:
*E-mail address: drsharmanitin@gmail.com (N. Sharma).
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Study design. CT, computed tomography; MRI, magnetic resonance imaging; DICOM, Digital Imaging and Communications in Medicine; 3D, three-dimensional; EBL, expected blood loss; iOS, iphone Operating System.
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| Criteria | Description | | Inclusion criteria | 1. Patient is 18 years or older | | 2. Patient should have or plan to have a contrast-enhanced CT scan or MRI | | Exclusion criteria | 1. Solitary or horseshoe kidney | | 2. More than two masses requiring multiple partial nephrectomies on the same side | | 3. Patient with prior partial nephrectomy on the affected side | | 4. Patient with renal vein or inferior vena cava thrombosis | | 5. Patient requiring bilateral partial nephrectomies | | 6. Metastatic disease with life expectancy less than 1 year | | 7. Pregnant or suspected pregnancy | | 8. Mentally handicapped, underlying psychological disorder or severe systemic illness precluding compliance with study requirements | | 9. Patient belonging to other vulnerable population, e.g., prisoner or ward of the state |
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Inclusion and exclusion criteria for the study.
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| Patient demographic | All patients for IRIS? (n=31) | R.E.N.A.L. nephrometry score | | 4-6 (n=8) | 7-9 (n=15) | 10-12 (n=8) | | Age, year | | | | | | Mean±SD | 65.1±14.9 | 55.5±21.4 | 70.1±7.4 | 65.4±14.9 | | Median (IQR) | 67.0 (57.0-74.0) | 57.0 (40.0-69.0) | 71.0 (63.0-74.0) | 66.5 (51.5-79.0) | | Gender (male:female) | 20:11 | 6:2 | 9:6 | 5:3 | | BMIa, kg/m2 | 30.6±6.5 | 27.7±3.3 | 32.1±7.7 | 30.9±6.0 | | ASA classification, n (%) | | | | | | Class 1 | 2 (6.5) | 2 (25.0) | 0 (0) | 0 (0) | | Class 2 | 12 (38.7) | 2 (25.0) | 7 (46.7) | 3 (37.5) | | Class 3 | 17 (54.8) | 4 (50.0) | 8 (53.3) | 5 (62.5) | | Class 4 | 0 (0) | 0 (0) | 0 (0) | 0 (0) | | Major abdominal surgery, n | 5 | 1 | 4 | 0 | | Laterality (left:right) | 11:20 | 4:4 | 6:9 | 1:7 | | Tumor location (anterior:hilar:posterior:other) | 11:10:9:1 | 5:0:3:0 | 5:4:5:1 | 1:6:1:0 | | Tumor sizea, mm | 27.7±17.3 | 26.5±18.9 | 25.3±12.4 | 33.1±23.5 | | Estimated hilar dissection timea, min | 12.5±8.5 | 12.5±8.5 | 11.7±9.0 | 25.0±20.6 | | Estimated tumor resection timea, min | 8.6±4.5 | 6.9±2.8 | 7.6±4.4 | 12.3±4.2 | | Estimated renorrhaphy timea, min | 12.8±7.3 | 10.3±3.9 | 14.7±13.7 | 16.5±8.5 | | LOSa, day | 1.7±1.1 | 1.1±0.4 | 1.7±1.1 | 2.3±1.3 |
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Patient demographics, medical and surgical history, and surgical outcomes (grouped according to R.E.N.A.L. nephrometry scores).
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A patient with a complex left renal mass (R.E.N.A.L. nephrometry score of 10). (A) Coronal images of abdominal computerized tomography scan; (B) IRIS? three-dimensional virtual reconstruction image on iphone Operating System device (Apple Park, Cupertino, CA, USA) of the same patient. R, right; L, left.
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| Preoperative questionnaires to surgeons' evaluating imaging using both IRIS? and CT scan | R.E.N.A.L. nephrometry score | All patients for IRIS? (n=31) | | 4-6 (n=8) | 7-9 (n=15) | 10-12 (n=8) | | Which part of the renal anatomy was IRIS? with CT scan helpful to achieve good spatial sensation | | Tumor location | 7 (87.5) | 15 (100.0) | 8 (100.0) | 30 (96.8) | | Renal artery identification | 7 (87.5) | 15 (100.0) | 8 (100.0) | 30 (96.8) | | Renal vein identification | 8 (100.0) | 15 (100.0) | 8 (100.0) | 31 (100.0) | | Tumor depth identification | 7 (87.5) | 15 (100.0) | 8 (100.0) | 30 (96.8) | | Relationship of tumor to surrounding structures | 6 (75.0) | 15 (100.0) | 8 (100.0) | 29 (93.5) | | Which part of the operation were you satisfied with the information available using IRIS? and CT scan | | Identification of ureter and vessels | 4 (50.0) | 11 (73.3) | 3 (37.5) | 18 (58.1) | | Identification of tumor location | 6 (75.0) | 15 (100.0) | 8 (100.0) | 29 (93.5) | | Identification of tumor depth | 6 (75.0) | 14 (93.3) | 8 (100.0) | 28 (90.3) | | Tumor resection for a complex tumor | 2 (25.0) | 8 (53.3) | 7 (87.5) | 17 (54.8) | | Aided in planning of off-clamp or segmental clamping | 3 (37.5) | 7 (46.7) | 4 (50.0) | 14 (45.2) | | Identification of feeding vessel to the tumor | 2 (25.0) | 11 (73.3) | 7 (87.5) | 20 (64.5) | | Not useful in this procedure | 1 (12.5) | 0 (0) | 0 (0) | 1 (3.2) | | You are confident that you will successfully complete the planned procedure | 8 (100.0) | 9 (60.0) | 4 (50.0) | 21 (67.7) | | How long did it take to visualize, assess, and interpret the IRIS? 3D model with CT scan for the purpose of surgical planning | | <1 min | 4 (50.0) | 4 (26.7) | 1 (12.5) | 9 (29.0) | | 2-5 min | 3 (37.5) | 9 (60.0) | 7 (87.5) | 19 (61.3) | | >5 min | 1 (12.5) | 2 (13.3) | 0 (0) | 3 (9.7) | | Which artery branch will you select for clamping based on IRIS? 3D model with CT scan | | Primary renal artery | 5 (62.5) | 4 (26.7) | 2 (25.0) | 11 (35.5) | | Secondary branch | 1 (12.5) | 4 (26.7) | 5 (62.5) | 10 (32.3) | | Tertiary branch | 0 (0) | 3 (20.0) | 1 (25.0) | 4 (12.9) | | Not applicable | 2 (25.0) | 4 (26.7) | 0 (0) | 6 (19.4) | | You feel the extra time spent on IRIS? technology was valuable | | Yes | 7 (87.5) | 15 (100.0) | 8 (100.0) | 30 (96.8) |
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Preoperative questionnaires given to surgeon.
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| Aspect of surgery | Questionnaire result | Overlap, % | | Preoperative | Intraoperative | | Interpretation of anatomy, n (%) | 31 (100.0) | 31 (100.0) | 100.0 | | Tumor location | 30 (96.8) | 31 (100) | 96.8 | | Renal artery | 30 (96.8) | 31 (100) | 96.8 | | Renal vein | 31 (100) | 31 (100) | 100.0 | | Tumor depth | 30 (96.8) | 31 (100) | 96.8 | | Relationship to surrounding structures | 29 (93.5) | 30 (96.8) | 96.7 | | The part of the operation or clinical situation where you were satisfied with the information available in the IRIS? 3D model with CT scan, n (%) | | Identification of ureter and vessels | 22 (71.0) | 21 (67.7) | 95.5 | | Identification of tumor location | 29 (93.5) | 30 (96.8) | 96.7 | | Identification of tumor depth | 28 (90.3) | 30 (96.8) | 93.3 | | Tumor resection for complex tumor | 17 (54.8) | 17 (54.8) | 100.0 | | Aided in planning of off-clamping or segmental clamping | 14 (45.2) | 14 (45.2) | 100.0 | | Identification of feeding vessel to the tumor | 20 (64.5) | 19 (61.3) | 95.0 | | Clamping techniquea, n | | | | | Primary renal artery clamping | 11 | 13 | 84.6 | | Off-clamp and selective clamping | 20 | 18 | 90.0 | | No clamp | 6 | 8 | 75.0 | | Secondary artery clamping | 10 | 7 | 70.0 | | Tertiary artery clamping | 4 | 3 | 75.0 |
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Preoperative predictive accuracy of IRIS? in comparison to intraoperative findings based on comparison of preoperative and intraoperative questionnaires.
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| Intraoperative questionnaires given to surgeons evaluating imaging using both IRIS? and CT scan | R.E.N.A.L. nephrometry score | All patients for IRIS? (n=31) | | 4-6 (n=8) | 7-9 (n=15) | 10-12 (n=8) | | The IRIS? 3D model with CT scan visualization method made your procedure efficient | | Agree and strongly agree | 5 (62.5) | 14 (93.3) | 8 (100.0) | 27 (87.1) | | The IRIS? 3D model with CT scan visualization method allowed the identification of target anatomy for this procedure | | Agree and strongly agree | 7 (87.5) | 15 (100.0) | 8 (100.0) | 30 (96.8) | | Does use of IRIS? model lead to any alteration in intraoperative plan compared to preoperative plan | | No | 8 (100.0) | 15 (100.0) | 8 (100.0) | 31 (100.0) | | How easy is IRIS? technology to use intraoperatively | | Very easy | 4 (50.0) | 11 (73.3) | 7 (87.5) | 22 (71.0) | | Easy | 4 (50.0) | 4 (26.7) | 1 (12.5) | 9 (29.0) | | Neutral, difficult, very difficult | 0 (0.0) | 0 (0.0) | 0 (0) | 0 (0.0) | | How many times did you refer to the IRIS? model with CT scan during the procedure | | 1-2 times | 6 (75.0) | 4 (26.7) | 1 (12.5) | 11 (35.5) | | 3 times | 2 (25.0) | 8 (53.3) | 3 (37.5) | 13 (41.9) | | 4-10 times | 0 (0) | 3 (20.0) | 2 (25.0) | 5 (16.1) | | >10 times | 0 (0) | 0 (0) | 2 (25.0) | 2 (6.5) | | Did you use the IRIS? model on iOS device or TilePro | | iOS device only | 7 (87.5) | 10 (66.7) | 1 (12.5) | 18 (58.1) | | TilePro only | 0 (0) | 0 (0) | 1 (12.5) | 1 (3.2) | | Both iOS and TilePro | 1 (12.5) | 5 (33.3) | 6 (75.0) | 12 (38.7) | | Do you think that using IRIS? model during surgery caused disruption to the procedure | | Yes | 0 (0) | 0 (0) | 0 (0) | 0 (0) | | Which feature of IRIS? software was most valuable | | Pan and rotate | 5 (62.5) | 14 (93.3) | 8 (100.0) | 27 (87.1) | | Alternating component transparency | 4 (50.0) | 11 (73.3) | 7 (87.5) | 22 (71.0) | | Slice display | 2 (25.0) | 1 (6.7) | 0 (0) | 3 (9.7) | | Windowing | 3 (37.5) | 1 (6.7) | 1 (12.5) | 5 (16.1) | | Do you think that interaction of the IRIS? software with CT scan was very intuitive | | Agree and strongly agree | 7 (87.5) | 15 (100.0) | 8 (100.0) | 30 (96.8) | | The IRIS? 3D model with CT scans could simplify the clinical case discussion with the patient | | Agree and strongly agree | 6 (75.0) | 15 (100.0) | 8 (100.0) | 29 (93.5) | | Was IRIS? a useful tool for discussion of the case with your trainees intraoperatively | | Agree and strongly agree | 7 (87.5) | 15 (100.0) | 8 (100.0) | 30 (96.8) | | The visual quality of the IRIS? is sufficient to support you preoperatively and intraoperatively | | Agree and strongly agree | 8 (100.0) | 14 (93.3) | 8 (100.0) | 30 (96.8) |
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Intraoperative questionnaires given to surgeons.
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Bland-Altman plot evaluating the difference in intraoperative and preoperative assessment on IRIS?. Orange line indicates the mean difference in questionnaires. 95% of the values (blue dot) lie within 2 standard deviation of mean difference in questionnaires. The calculated 95% confidence interval of ?0.531-1.076 is suggestive of insignificant or no difference between preoperative and intraoperative response based on the questionnaires.
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