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Safety and effectiveness of percutaneous renal cryoablation with conscious sedation Safety and effectiveness of percutaneous renal cryoablation with conscious sedation
Patel, Sagar Rohitkumar; Francois, Sean; Bhamber, Tiagpaul; Evans, Holt; Gaston, Kris; Riggs, Stephen B.; Teigland, Chris; Clark, Peter E.; Roy, Ornob P.
2020-07-02 00:00:00
ARAB JOURNAL OF UROLOGY 2020, VOL. 18, NO. 3, 163–168 https://doi.org/10.1080/2090598X.2020.1739382 ONCOLOGY RECONSTRUCTION: ORIGINAL ARTICLE Safety and effectiveness of percutaneous renal cryoablation with conscious sedation a,b a,b a a a a Sagar Rohitkumar Patel , Sean Francois , Tiagpaul Bhamber , Holt Evans , Kris Gaston , Stephen B. Riggs , a a a Chris Teigland , Peter E. Clark and Ornob P. Roy a b Department of Urology, Atrium Health, Charlotte, NC, USA; Department of Urology, University of North Carolina, Chapel Hill, NC, USA ABSTRACT ARTICLE HISTORY Receiced 08 February 2020 Objective: To investigate complications and treatment failure rates of percutaneous renal Accepted 18 February 2020 cryoablation (PRC) for small renal masses under local anaesthesia and conscious sedation (LACS), to assess the safety and effectiveness of this approach, as PRC is typically performed KEYWORDS under general anaesthesia (GA). Percutaneous renal Patients and methods: We retrospectively reviewed PRC under LACS from 2003 to 2017. We cryoablation; conscious analysed perioperative parameters between patients who successfully underwent PRC under sedation; general LACS and patients with post-procedural complications or treatment failure (renal mass anaesthesia; complications; disease recurrence enhancement after successful intraoperative tumour ablation). Two-sided non-parametric and Fisher’s exact tests were performed to compare uncomplicated or disease-free PRC with the complication or treatment failure group, respectively. Results: A total of 100 PRCs under LACS were performed during the study period. Of these patients, six patients had at least one postoperative complication (6%), and treatment failure was diagnosed in nine patients (9%) after PRC [mean (SD) follow-up of 42.7 (26.6) months]. The procedural failure rate was 1%. No ablations were converted to GA. The mean tumour size was smaller in patients who had no complications during PRC compared to those who did, at a mean (SD) of 2.2 (0.6) cm vs 3.0 (1.0) cm (P = 0.039). The use of more intraoperative probes during the PRC was also associated with complications, at a mean (SD) 3.0 (1.4) vs 1.8 (0.8) (P = 0.021). Conclusions: PRC under LACS is an effective and safe procedural approach for managing small renal masses with low complication, treatment failure, and procedural failure rates. Larger renal masses and intraoperative use of multiple probes is associated with an increased risk of PRC complications. Abbreviations: BMI: body mass index; CCI: Charlson Comorbidity Index; GA: general anaes- thesia; LACS: local anaesthesia and conscious sedation; PRC: percutaneous renal cryoablation; R.E.N.A.L.: Radius, Exophytic/Endophytic, Nearness, Anterior/Posterior, Location Introduction However, to our knowledge, there are no published studies that analyse factors associated with proce- In recent years, incidental findings of small renal dural complications and treatment failure after PRC masses have dramatically increased with the perva- under LACS. sive use of cross-sectional imaging [1,2]. For selected The economic and psychosocial impacts of more patients, image-guided percutaneous ablation has invasive operations are significant for patients. Even become a viable option for the treatment of small though thermal ablation has comparable outcomes renal tumours [3,4]. Compared to more invasive pro- to nephrectomies, complications do occur and local cedures, e.g. open or laparoscopic partial nephrect- recurrence is higher in cryoablation [9]. Although omy, percutaneous renal cryoablation (PRC) greatly uncommon, postoperative complications associated reduces post-surgical complications and recovery with renal mass ablation include haematoma forma- time [5]. Historically, PRC has been performed under tion, urine leak, bleeding risk, and infection [8,10,11]. general anaesthesia (GA) with endotracheal intuba- However, current literature lacks information about tion. Given the risks associated with anaesthesia, par- complications, treatment and procedural failures ticularly in patients with several comorbid conditions, rates after PRC under LACS. In the present retrospec- PRC with local anaesthesia and conscious sedation (LACS) was developed as an alternative treatment tive study, we determined the safety and effective- modality [6,7]. Interestingly, PRC of small masses ness of PRC under LACS by analysing postoperative under LACS reduced the perioperative time and shor- complications, treatment failure, and procedural fail- tened hospital stay compared to PRC under GA [8]. ure rates. CONTACT Sagar Rohitkumar Patel sagar_patel@med.unc.edu Department of Urology, Atrium Health, 1023 Edgehill Road South, Charlotte 28207, USA © 2020 The Author(s). Published by Informa UK Limited, trading as Taylor & Francis Group. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. 164 S. R. PATEL ET AL. Annual abdominal CT and chest X-ray were obtained Patients and methods at 5 years post-PRC to assess for treatment failure. Patient population Renal biopsy was scheduled if there was clinical suspi- cion of local recurrence for patients with no documen- The Institutional Review Board approved the retro- ted preoperative renal biopsy. Determination of spective analysis of patients who underwent PRC disease recurrence was based on CT results and/or with LACS for renal masses from 2003 to 2017. Data postoperative renal biopsy. Treatment failure was were obtained from Atrium Health at Carolinas Medical defined as renal mass enhancement after successful Center Main campus. Patients diagnosed with a solid, intraoperative tumour ablation. Procedural failure was enhancing renal tumour underwent complete history defined as inability to execute PRC intraoperatively. and physical, laboratory testing, and radiological con- Information about patient’s R.E.N.A.L. (Radius, firmation. The following variables were obtained for Exophytic/Endophytic, Nearness, Anterior/Posterior, the study: patient demographics; past medical history; Location) nephrometry score, maximal tumour dia- tumour features including size, laterality, polarity, loca- meter (M), central tumour location (C), myocardial tion, morphology, and biopsy results; perioperative infarction history (M), and complicated diabetes his- and postoperative parameters. tory (C) [(MC)2] complication risk scores [12], and com- plications were recorded. Postoperative complications Description of procedure were graded using the Clavien–Dindo Classification system. PRC candidates were selected by urologists, and the procedure was performed by radiologists experienced with percutaneous cryoablation. Patients were sedated Statistical analysis with 1–6 mg midazolam (Versed) and 75–150 mg fen- tanyl. Lidocaine (1%) was used at the probe site for We used the mean and standard deviation (SD) to local anaesthesia. For the PRC procedure, the patient represent continuous variables and proportions to was placed prone or oblique to locate the renal mass represent categorical variables. Statistical analysis was with CT and/or ultrasonography. Before 2017, renal completed with statistical software from the SAS tumour biopsy was obtained in selected patients on Institute (Cary, NC, USA), JMP® Pro. The Shapiro–Walk a case-by-case basis. Since 2017, the practice has test was used to determine that the dataset was not altered such that all patients now undergo an attempt normally distributed. Thus, we performed two-sided at biopsy before PRC. At the time of the ablation, the non-parametric tests (Wilcoxon test) and Fisher’s cryoablation probe (Galil Medical Inc., St Paul, MN, exact tests to compare uncomplicated or disease-free USA) was inserted into the mass via CT or ultrasono- PRC with the complication or treatment failure group, graphic guidance. The probe was cycled through two respectively. A P < 0.05 was used to determine signifi- freeze–thaw stages: 10 min of freezing (to at least – 40° cance of statistical tests. C), 8 min of active thaw, and 10 min of re-freezing followed by another thaw; no thremocoupling was performed with the ablation technique. Following the Results final thaw, the cryoprobe was removed. CT is per- Patient demographics formed during the procedure to determine the ice ball size and after the removal of the probe to evaluate During the study period, 100 renal masses underwent for complications or residual mass tissue. After the PRC, PRC with LACS whereas only seven patients in our patients were observed until mental status returned to database underwent ablation with GA. Patient demo- baseline and discharged the same day of the proce- graphics are presented in Table 1. The mean (SD) dure. If patients showed persistent altered mental sta- patient age was 75 (11.6) years, and 64% and 36% of tus or haemodynamic instability, they were admitted the cohort were male and female, respectively. The overnight for observation and appropriate mean (SD) body mass index (BMI) was 31 (7.7) kg/m management. and 33% of the patients were either active smokers or Table 1. Patient demographics and treatment parameters. Postoperative follow-up and data collection Variable Value Patients were scheduled for 1-month follow-up Number of patients 100 Age, years, mean (SD) 75 (11.6) appointments to monitor renal function via basic Gender: male, female, % 64, 36 metabolic panel and recovery after the procedure. 2 BMI, kg/m , mean (SD) 31 (7.7) Smoker, % 33 Following the initial postoperative outpatient appoint- CCI Score, mean (SD) 5.5 (2.1) ment, patients were scheduled for regular follow-up Number of probes, mean (SD) 1.9 (0.9) visits between 3 and 6 months with contrast-enhanced Sedation time, min, mean (SD) 65.6 (2.4) Biopsy, % 29 CT imaging to assess for any residual renal tumour. ARAB JOURNAL OF UROLOGY 165 had a smoking history. The mean (SD) Charlson significant comorbidity, and four patients were hospita- Comorbidity Index (CCI) was 5.5 (2.1). The mean (SD) lised for more than one night for post-procedural com- number of probes used during the PRC was 1.9 (0.9). plications. Case descriptions for patients with com CT-guided ablation was performed in 98 cases, while plications and treatment failure after PRCs are outlined two cases were guided by ultrasound. In all, 29% of the in Table 3. Of the variables analysed, only tumour size patients had biopsies taken during or prior to the and number of probes were significantly associated with procedure. Six patients were lost during follow-up, complication rates (Table 4). The mean (SD) tumour size with a mean (SD) period from time of procedure to in patients who underwent PRC was larger in cases with last follow-up appointment of 43.5 (26.7) months. complications than without complications, at 3.0 (1.0) vs 2.2 (0.6) cm (P = 0.039). Higher mean (SD) number of intraoperative probes during the cryoablation was asso- Tumour characteristics ciated with complications, at 3.0 (1.4) vs 1.8 (0.8) (P = 0.021). Patient’sage,age-adjustedCCI,BMI, and Tumour characteristics are listed in Table 2. The mean total R.E.N.A.L. score were not associated with PRC com- (SD) total R.E.N.AL. score was 5.96 (1.9). The mean (SD) plications. In the complication group, there was a non- tumour size was 2.22 (0.68) cm, with 17% of patients significant trend toward numerically higher CCI scores having tumours of >3 cm. In all, 19% of tumours were and older age compared to those without a located anteriorly and 49% were posterior on the kid- complication (P = 0.118 and P = 0.189, respectively). ney. Of the renal masses, 13 were in the upper pole, 41 Patients with complications had significantly longer hos- were in the middle pole, and 37 were in the lower pole pitalisations (4.1 days) compared to these without com- (of note, select patients’ R.E.N.A.L. score components plications (P < 0.001). Complications and treatment were not documented in the electronic medical failure were not associated with (MC)2 risk scores records, creating discrepancies in our total percentage (P = 0.838 and P = 0.356, respectively). Documented calculations). Tumour biopsies were not taken in 71% complications during the PRC under LACS included: of patients. Positive biopsy specimens included 18 ureteric injury, haematoma, bleeding, pneumonia, and RCCs, one oncocytoma, and one angiomyolipoma. acute renal failure. No parameters were associated with treatment failure (Table 4). Of the nine patients who had local recurrence, the options of active surveillance, re- Complication and treatment failure rates ablation, and surgery were offered. Four patients died of Six patients (6%) had complications during the PRC and non-cancer-related diseases. Five patients underwent nine patients (9%) had treatment failure; the procedural repeat PRC. Three patients were managed with radial failure rate was 1%, due to poor renal visualisation dur- nephrectomy; one patient underwent partial nephrect- ing intraoperative CT. The mean (SD) follow-up interval omy. All nine patients remained disease free after sec- for the treatment failure group was 42.7 (26.6) months. ondary interventions. None of the PRCs were converted from LACS to GA. Three patients required overnight observation for Discussion The risks associated with GA cannot be disregarded. In Table 2. Tumour characteristics. recent years, there has been an overall rise in anaesthe- Variable Value sia-related mortality given that surgical interventions Total R.E.N.A.L. Score, mean (SD) 5.96 (1.9) R Score: tumour size, cm, mean (SD) 2.22 (0.68) are more common among more frail patients and the Tumour >3 cm, % 17 number of complex invasive operations has increased E Score: tumour growth pattern, % Exophytic 53 [13]. Furthermore, with older adults living longer, the Mesophytic 32 geriatric population is undergoing more procedures. Endophytic 15 N Score: nearness to collecting system, % These procedures under GA have a higher incidence of ≥7mm 64 postoperative complications such as: delirium, cognitive 4–7mm 15 <4 mm 19 dysfunction, delayed rehabilitation, and mortality [14]. A Score: anatomical location, % Given these facts, LACS for PRC has become a viable Anterior 19 option for small renal masses. However, the PRC litera- Posterior 49 Neither 32 ture focusses on cases employing GA. We explored L Score: polarity line, % perioperative parameters that are associated with pro- Above/below 39 Crosses polar line 31 cedural complications and treatment failure to assess 50% crosses pole/between poles 28 the safety and effectiveness of PRC with this novel mode Tumour site, % Upper Pole 13 of anaesthesia. Specifically, our present study showed Middle Pole 41 that PRC under LACS is a viable option for complex renal Lower Pole 37 tumours and patients with significant comorbidity. 166 S. R. PATEL ET AL. Table 3. Parameters for patients with postoperative complications or treatment failure after PRC. Patient Tumour R.E.N.A.L. No. of Complications Treatment Procedural CCI ASA no. size, cm Tumour location Score probes (Grade) failure failure Score Score 1 1.8 Mesophytic left upper pole 4 - Unable to perform No Yes 6 I 2 1.5 Mesophytic left lower pole 5 1 Haematoma (1) No No 7 III 3 2.2 Endophytic right lower pole 4 2 Ureteric Injury (3a) No No 5 II 4 4 Endophytic right middle pole 9 3 Pneumonia (2) Yes No 5 III 5 3.9 Exophytic left middle pole 9 4 Bleeding (1) No No 7 II 6 3.6 Mesophytic right lower pole 9 5 Haematoma, Renal No No 10 I failure (4a) 7 3 Endophytic right upper pole 8 3 Bleeding (1) No No 7 II 8 1.4 Endophytic right lower pole 6 2 None Yes No 3 II 9 1.6 Mesophytic right middle pole 4 1 None Yes No 2 III 10 1.8 Exophytic left lower pole 4 1 None Yes No 7 IV 11 2 Exophytic left lower pole 6 2 None Yes No 8 II 12 2 Exophytic left lower pole 6 2 None Yes No 8 II 13 2.2 Mesophytic right lower pole 5 2 None Yes No 8 II 14 1.8 Exophytic right lower pole 6 1 None Yes No 5 III 15 2.5 Exophytic left hilum 8 2 None Yes No 7 IV ASA: American Society of Anesthesiologists; Grade was determined by the Clavien–Dindo Classification system. Table 4. Univariate analysis of pre- and intraoperative vari- use of LACS over GA [16]. Further investigation is neces- ables for complications and treatment failure after PRC. sary to quantify the cost benefit of PRC with LACS Treatment Complications failure compared to other forms of sedation, especially as the Variable No Yes P No Yes P procedural failure rate is extremely low (1%) and no No. of patients 94 6 91 9 PRCs were converted to GA. Gender, % The R.E.N.A.L. nephrometry score is associated with Male 64.9 50.0 0.664 65.9 55.6 0.277 Female 35.1 50.0 0.664 34.1 44.4 0.277 more complications in PRC with GA [17]. Our present Age, years, mean 74.7 80.8 0.189 75.2 74.0 0.962 Tumour size, cm, mean 2.2 3.0 0.039* 2.2 2.1 0.571 study is the first to assess the association of R.E.N.A. Tumour side, % L. nephrometry score with postoperative complications Right 46.8 66.7 0.423 47.3 55.6 0.734 Left 53.2 33.3 0.423 52.7 44.4 0.734 and ablation failure under LACS, suggesting that these Number of probes, mean 1.8 3.0 0.021* 1.9 1.8 0.802 rates are not associated with more complex renal CCI, mean 5.4 6.8 0.118 5.5 5.9 0.423 BMI, kg/m , mean 31.0 29.0 0.586 30.5 34.5 0.097 masses. The (MC)2 PRC risk calculator, developed from R.E.N.A.L. Score, mean 5.9 7.3 0.109 6.0 6.0 0.990 PRC under GA, was refuted by analysis of our present (MC)2 Score, mean 3.9 4.0 0.838 3.8 4.3 0.356 Maximal tumour diameter 2.6 3.3 <0.001* 2.7 2.7 0.926 cohort with LACS [18]. Moreover, our present data Myocardial infarction history 0.0 0.0 0.802 0.0 0.0 0.755 Central tumour location 0.1 0.3 0.368 0.1 0.0 0.363 demonstrated that tumour size was significantly larger Complicated diabetes 1.1 0.5 0.336 1.0 1.7 0.179 in those patients who had complications. In a recent Hospital stay, days, mean 0.03 4.1 <0.001* 0.3 0.0 0.606 study, the most important factor in predicting major *Indicates statistical significance; note: Wilcoxon test and Fisher’s exact were performed for continuous and categorical variables, respectively. PRC complications was tumour diameter for patients under GA and often associated with post-procedural bleeding [18]. Our present data is consistent with the Recent studies have shown that PRC with LACS is as Schmit et al. [18] study, in that tumour diameter is safe and effective as GA [8]. A larger series by de Kerviler predictive of postoperative complications in both et al. [15], initially demonstrated PRC was a feasible types of anaesthesia [4]. Furthermore, higher BMI and option without GA, with low pain scores and short comorbidity did not increase the risk of post-procedural procedure duration, but noted a higher complication injury during LACS in our present study. Other than rate of 14.0%. In support, our present data shows that tumour bulk, PRC under LACS is relatively safe in regard PRC under LACS has a lower complications rate (6%). In to tumour complexity and comorbidity status. our present study, the treatment failure rate of 9% is Post-procedural bleeding is the most common com- similar to previously reported recurrence rates after PRC plication after PRC. Studies note that 0.9–8.3% of PRC under LACS (5.8%) and GA (6%) [8,16]. Not surprisingly, cases require blood transfusion [12]. In our present patients who underwent PRC with LACS had study, two patients had postoperative bleeding (2%); asignificantly shorter hospitalisation course (average both these cases were able to be managed conserva- 1.08 days) compared to GA (average 1.95 days) [8]. tively without the need for transfusions or embolisa- With comparable surgical outcomes to ablation with tion. These patients had a tumour burden of 3 and GA, PRC under LACS may confer advantages for selected 3.9 cm, which has been shown to be a risk factor for patients given the risks associated with anaesthesia. As postoperative bleeding [19]. LACS does not necessarily require consultation of the Similar to postoperative bleeding, the incidence of anaesthesiology team compared to GA, this may alle- haematoma formation significantly increases with viate healthcare expenses. Cost–benefit analysis of sev- increasing tumour size and the number of probes used eral other minimally invasive procedures also favour the during the procedure [10]. Of the perirenal haematoma ARAB JOURNAL OF UROLOGY 167 complications, only one probe was used in one of the Disclosure statement patients. Hafron and Kaouk [12] stated that haemorrhage The authors declare that there are no conflicts of interest was solely associated with the use of multiple probes. The regarding the publication of this paper. average number of probes used during PRC without complications was 1.8 probes in our present study. Our Funding present data demonstrates that significantly more probes (mean 3.0) were used intraoperatively for patients that There was no outside funding regarding the publication of subsequently developed complications. this paper. Injuries to the collecting system have been pre- viously reported after PRC [20]. Sung et al. [21] studied Author contributions the short- and long-term sequelae of intentional cryoa- blation of the renal collecting system. Collecting sys- Sagar Patel drafted the manuscript and researched the cur- tem injury is fairly uncommon; often these injuries heal rent literature. Sean Francois, Tiagpaul Bhamber and Holt by secondary closure with stent placement [22]. In our Evans collected primary data from electronic medical records. Patients were managed and seen by Kris Gaston, present retrospective analysis, we reported one ure- Stephen B. Riggs, Chris Teigland, and Ornob Roy. Peter Clark teric complication requiring JJ-stent placement provided feedback on manuscript. Ornob Roy supervised the demonstrating the low rate of ureteric injury. project and provided edits to manuscript. There are several limitations to the present study including small sample size, lack of comparison Statement of ethics group with GA, short duration of follow-up and low events of complications. Due to retrospective This manuscript has not been published in whole or part analysis, data extrapolated from the study can only elsewhere nor currently being considered for publication in show associations and is prone to selection bias. another journal. All authors have been personally and Only 29% of the cohort had biopsies. For the actively involved in the publication of this paper and will hold themselves jointly and individually responsible for its remaining patients, we are uncertain about the content. Personal and identifying information regarding the pathology of the renal tumour, limiting the extent case has been retracted for confidentiality purposes. to which we can evaluate effectiveness of PRC for certain types of renal masses. Prior clinicians at our hospital system did not routinely perform renal ORCID biopsies before PRC because of the perceived Sagar Rohitkumar Patel http://orcid.org/0000-0001-7183- increased risk of complications from the biopsy itself. However, with more experience and recogni- tion of the safety and benefits of percutaneous References renal mass biopsy, radiologists at our hospital have started to routinely collect pathology specimens [1] Rodriguez Faba O, Akdogan B, Marszalek M, et al. before ablation. Despite these limitations, we Current status of focal cryoablation for small renal demonstrate that PRC under LACS can be per- masses. Urology. 2016;90:9–15. [2] Silverman SG, Israel GM, Trinh QD. Incompletely charac- formed safely in patients with complex renal terized incidental renal masses: emerging data support tumours and significant comorbidity, with relatively conservative management. Radiology. 2015;275:28–42. low post-procedural complications, re-treatment, [3] Zondervan PJ, Buijs M, de la Rosette JJ, et al. Cryoablation and procedural failure rates. of small kidney tumors. Int J Surg. 2016;36:533–540. [4] Aoun HD, Littrup PJ, Jaber M, et al. Percutaneous cryoablation of renal tumors: is it time for a new para- digm shift? J Vasc Interv Radiol. 2017;28:1363–1370. Conclusion [5] Klatte T, Shariat SF, Remzi M. 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With this knowledge, clinicians can bet- 2016;196:989–999. ter select patients for renal tumour ablation and edu- [7] Permpongkosol S, Sulman A, Solomon SB, et al. cate patients about PRC under LACS, as well as Percutaneous computerized tomography guided consistently trust this technique due to low procedural renal cryoablation using local anesthesia: pain failure and conversion to GA rates. assessment. J Urol. 2006;176:915–918. 168 S. R. PATEL ET AL. [8] Okhunov Z, Juncal S, Ordon M, et al. Comparison of local anaesthesia. Cardiovasc Intervent Radiol. 2015; outcomes in patients undergoing percutaneous renal 38:672–677. cryoablation with sedation vs general anesthesia. [16] Toppen W, Johansen D, Sareh S, et al. Improved costs Urology. 2015;85:130–134. and outcomes with conscious sedation vs general [9] Fraisse G, Colleter L, Peyronnet B, et al. Peri-oper anesthesia in TAVR patients: time to wake up? 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