To determine the incidence of major adverse events related to a large volume of image-guided liver biopsies performed at our institution over a 12-year period and to identify risk factors for major ...bleeding events.
A retrospective analysis of an internally maintained biopsy registry was performed. The analysis revealed that 6613 image-guided liver biopsies were performed in 5987 adult patients between December 7, 2001, and December 31, 2013. Liver biopsies were performed using real-time ultrasound guidance and a spring-loaded biopsy device, with rare exceptions. Adverse events considered major and included in this study were hematoma, infection, pneumothorax, hemothorax, and death. Using data from the biopsy registry, we evaluated statistically significant risk factors (P<.05) for hematoma related to image-guided liver biopsy, including coagulation status, biopsy technique, and medications.
A total of 49 acute and delayed major adverse events (0.7%) occurred after 6613 liver biopsy events. The incidence of hematoma requiring transfusion and/or angiographic intervention was 0.5% (34 of 6613). The incidence of infection was 0.1% (8 of 6613), and that of hemothorax was 0.06% (4 of 6613). No patient (0%) incurred a pneumothorax after biopsy. Three patients (0.05%) died within 30 days of liver biopsy, 1 being directly related to biopsy. Thirty-eight of 46 major adverse events (83%) presented acutely (within 24 hours). More than 2 biopsy passes, platelets 50,000/μL or less, and female sex were statistically significant risk factors for postbiopsy hemorrhage.
Image-guided liver biopsy performed by subspecialized interventionalists at a tertiary medical center is safe when the platelet count is greater than 50,000/μL. With appreciation of specific risk factors, safety outcomes of this procedure can be optimized in both general and specialized centers.
Abstract Context Cryoablation (CA) is a minimally invasive modality with low complication rates, but its use in urology is relatively recent. Objective To summarize available evidence for CA for ...small renal masses (SRMs) and to assess the selection criteria, complications, and functional and oncologic results based on the latest CA literature. Evidence acquisition A systematic literature search of the Medline, Embase, and Scopus databases was performed in August 2014 using Medical Subject Headings and free-text protocol. The following search terms were included: kidney cryosurgery, renal cryosurgery, kidney cryoablation, renal cryoablation, kidney cryotherapy , and renal cryotherapy. Evidence synthesis Due to the relatively recent mainstream utilization of CA and lack of long-term efficacy data from large prospective or randomized studies, most of the data available on CA are limited to treatment of SRMs in patients who are often older or are poor surgical candidates. The rates of major complications across the CA literature remain relatively low. Studies assessing renal function after CA suggest a degree of functional decline following CA because proper application includes freezing of a tumor margin; however, often this is not clinically significant. Specific oncologic outcomes should be evaluated in patients with biopsy-proven renal cell carcinoma; when SRM series include benign or unbiopsied tumors, the results of these outcomes are skewed. Although earlier series were suggestive of a higher recurrence rate after CA, some studies have challenged this view reporting recurrence rates comparable with extirpative nephron-sparing surgery. Conclusions CA represents an alternative approach to treatment for patients diagnosed with renal neoplasm. There is no consensus within the literature on the best patient selection criteria. Due to higher rates of treatment failure, it is often not offered to patients with minimal comorbidities and good life expectancy. In terms of functional outcomes, CA signifies a modality with minimum impact on renal function; however, well-designed studies precisely assessing this factor are lacking. CA is a minimally invasive modality with suitably low rates of complications, particularly if delivered via the percutaneous route. Patient summary Cryoablation (CA) represents an alternative approach for treating renal neoplasm. Excellent functional outcomes and low rates of complications make CA an ideal minimally invasive modality. Patient selection criteria and oncologic outcomes require further study.
To describe the use of intraprocedural motor evoked potential (MEP) monitoring to minimize risk of neural injury during percutaneous cryoablation of perineural musculoskeletal tumors.
A ...single-institution retrospective review of cryoablation procedures performed to treat perineural musculoskeletal tumors with the use of MEP monitoring between May 2011 and March 2013 yielded 59 procedures to treat 64 tumors in 52 patients (26 male). Median age was 61 years (range, 4-82 y). Tumors were located in the spine (n = 27), sacrum (n = 3), retroperitoneum (n = 4), pelvis (n = 22), and extremities (n = 8), and 21 different tumor histologies were represented. Median tumor size was 4.0 cm (range, 0.8-15.0 cm). Total intravenous general anesthesia, computed tomographic guidance, and transcranial MEP monitoring were employed. Patient demographics, tumor characteristics, MEP findings, and clinical outcomes were assessed.
Nineteen of 59 procedures (32%) resulted in decreases in intraprocedural MEPs, including 15 (25%) with transient decreases and four (7%) with persistent decreases. Two of the four patients with persistent MEP decreases (50%) had motor deficits following ablation. No functional motor deficit developed in a patient with transient MEP decreases or no MEP change. The risk of major motor injury with persistent MEP changes was significantly increased versus transient or no MEP change (P = .0045; relative risk, 69.8; 95% confidence interval, 5.9 to > 100). MEP decreases were 100% sensitive and 70% specific for the detection of motor deficits.
Persistent MEP decreases correlate with postprocedural sustained motor deficits. Intraprocedural MEP monitoring helps predict neural injury and may improve patient safety during cryoablation of perineural musculoskeletal tumors.
Extraabdominal desmoid (EAD) tumors pose a therapeutic challenge because they often recur locally and behave aggressively. Accepted management options include surgery, radiation, chemotherapy, and ...observation. The objective of this study was to assess the safety and efficacy of percutaneous cryoablation for the treatment of EAD tumors.
A retrospective search of our cryoablation database was performed to identify patients with EAD tumors treated with percutaneous cryoablation between June 15, 2004, and June 15, 2014. During this 10-year time period, we treated 18 patients with 26 discrete tumors during 31 treatment sessions. After cryoablation, contrast-enhanced MRI or CT was performed. Any enhancing soft tissue was considered viable EAD tumor and was measured in three planes.
Of the 26 EAD tumors treated, follow-up imaging with IV contrast material was available for 23 tumors. The mean imaging follow-up was 16.2 ± 20.0 (SD) months. All 31 sessions were technically successful procedures. No residual viable EAD tumor was observed in nine of 23 tumors (39.1%). Some degree of volume reduction was evident in 22 of 23 tumors (95.7%). Progressive disease was observed in one of the 23 tumors (4.3%). Of the cases with residual or progressive disease, the recurrence occurred at the margin of the treated tumor in all cases. No major complications were observed, and none of the complications was more severe than Clavien-Dindo grade I.
Percutaneous cryoablation is a safe, effective, and repeatable treatment for achieving local control of EAD tumors.
To review complications related to percutaneous renal tumor ablation.
Prospectively collected data related to renal radiofrequency (RF) ablation and cryoablation procedures performed from May 2000 ...through November 2010 were reviewed. This included 573 renal ablation procedures performed in 533 patients to treat 633 tumors. A total of 254 RF ablation and 311 cryoablation procedures were performed; eight patients underwent simultaneous RF ablation and cryoablation. The mean age of patients at the time of the procedure was 70 years (range, 24-93 y), and 382 of 573 procedures (67%) were performed in male patients. Complications were recorded according to the Clavien-Dindo classification scheme. Duration of hospitalization was also documented.
Of the 573 procedures, 63 produced complications (11.0% overall complication rate). There were 66 reported complications, of which 38 (6.6% of total procedures) were Clavien-Dindo grade II-IV major complications; there were no deaths. Major complication rates did not differ statistically (P = .15) between cryoablation (7.7%; 24 of 311) and RF ablation (4.7%; 12 of 254). Of the complications related to cryoablation, bleeding and hematuria were most common. Bleeding during cryoablation was associated with advanced age, increased tumor size, increased number of cryoprobes, and central position (P < .05). Of those treated with RF ablation, nerve and urothelial injury were most common. Mean hospitalization duration was 1 day for RF ablation and cryoablation.
Complications related to percutaneous renal ablation are infrequent. Recognition of potential complications and associated risk factors can allow optimization of periprocedural care.
To describe the technical methods, safety, and local tumor control rate associated with percutaneous cryoablation of stage T1b renal cell carcinoma (RCC).
A retrospective review of a percutaneous ...renal ablation registry was used to identify 46 patients with a total of 46 biopsy-proven RCC lesions measuring 4.1-7.0 cm treated with cryoablation between 2003 and 2011. The main outcome parameters investigated were adjunctive maneuvers, complications, and local tumor progression, and cancer-specific survival rates. Complication rates were categorized and recorded using the Clavien-Dindo classification system. Progression-free and cancer-specific survival rates were estimated using the Kaplan-Meier method.
The mean treated RCC size was 4.8 cm (range, 4.1-6.4 cm). Prophylactic tumor embolization was performed in 7 patients (15%), ipsilateral ureteral stents were placed in 7 patients (15%), and hydrodisplacement of bowel was performed in the treatment of 16 tumors (35%). A single technical failure (2.2%) was observed at the time of ablation. Thirty-six tumors (78%) had follow-up imaging at 3 months or later following ablation, including a single recurrence at 9 months after ablation. The mean duration of follow-up for the 35 RCC tumors that did not recur was 2.0 years (range, 0.3-6.1 y). Estimated local progression-free survival rate at 3 years was 96.4%. Of the 46 cryoablation procedures, there were 7 complications (15.2%) of grade II or worse.
The results suggest that cryoablation represents a valid treatment alternative for select patients with clinical stage T1b RCC. Complications are frequent enough that multidisciplinary patient management should be considered.
The purpose of this article is to compare the efficacy and complication rates of percutaneous radiofrequency ablation (RFA) and cryoablation in the treatment of renal masses measuring 3.0 cm and ...smaller.
A retrospective review was performed of 385 patients with 445 tumors measuring 3.0 cm or smaller treated with thermal ablation from 2000 through 2010. Two hundred fifty-six tumors in 222 patients were treated with RFA (mean ± SD tumor size, 1.9 ± 0.5 cm), and 189 tumors in 163 patients were treated with cryoablation (mean tumor size, 2.3 ± 0.5 cm). Major complications and efficacy as measured by technical success and local tumor recurrence rates were recorded.
There were five (1.1%) technical failures, including one (0.4%) among tumors treated with RFA and four (2.1%) among tumors treated with cryoablation (p = 0.17). Of the 218 tumors treated with RFA and with follow-up beyond 3 months, seven (3.2%) developed local tumor recurrence, at a mean of 2.8 years after treatment (range, 1.2-4.1 years). Of the 145 tumors treated with cryoablation and with follow-up beyond 3 months, four (2.8%) developed local tumor recurrence at a mean of 0.9 years after treatment (range, 0.3-1.6 years). For biopsy-proven renal cell carcinoma, estimated local recurrence-free survival rates at 1, 3, and 5 years after RFA were 100%, 98.1%, and 98.1%, respectively, compared with 97.3%, 90.6%, and 90.6%, respectively, after cryoablation (p = 0.09). Major complications occurred after 4.3% (10/232) of RFAs and 4.5% (8/176) of cryoablation procedures (p = 0.91).
RFA and cryoablation are both effective in the treatment of renal masses measuring 3 cm or smaller. Major complications with either procedure are infrequent.
Purpose We applied the R.E.N.A.L. (radius, exophytic/endophytic, nearness to collecting system or sinus, anterior/posterior and location relative to polar lines) nephrometry scoring system to renal ...tumors treated with percutaneous ablation to determine whether this score is associated with oncological outcomes and complications. Materials and Methods A total of 751 renal tumors were treated at 679 percutaneous ablation sessions in 627 patients at our institution between 2000 and 2012. Of these renal masses 430 (57%) were treated with cryoablation and the remaining 321 were treated with radio frequency ablation. R.E.N.A.L. tumor scores were analyzed to determine the association of the score with ablation treatment outcomes and complications according to Clavien criteria. Results The mean ± SD R.E.N.A.L. nephrometry score of all ablated tumors was 6.7 ± 1.9. Those treated with cryoablation had higher scores than those treated with radio frequency ablation (mean 7.2 ± 1.9 vs 6.1 ± 1.8, p <0.001). We identified a total of 28 local treatment failures (3.7%) in the 751 tumors during a mean computerized tomography/magnetic resonance imaging followup of 27.9 ± 27.8 months. There was a significant association between R.E.N.A.L. nephrometry score and local treatment failure. Mean nephrometry score was 7.6 ± 2.2 vs 6.7 ± 1.9 for tumors with vs without local treatment failure (p <0.001). Of the 679 ablation treatments 38 (5.6%) major (grade 3 or greater) patient complications occurred. There was a significant association between R.E.N.A.L. nephrometry score and major complications. Patients with vs without a major complication had a mean nephrometry score of 8.1 ± 2.0 vs 6.8 ± 1.9 (p <0.001). Conclusions The R.E.N.A.L. nephrometry scoring system predicts treatment efficacy and complications following percutaneous renal ablation.
The objective of our study was to report the incidence of bleeding after imaging-guided percutaneous core biopsy at a single center using a standardized technique.
We performed a retrospective review ...of percutaneous core biopsies performed at our institution from January 2002 through February 2008. Data were collected at the time of biopsy, and clinical information was obtained 24 hours and 3 months after the biopsy. The specific information that was collected included the results of coagulation studies, aspirin use, the organ biopsied, the size of the biopsy needle, and the number of needle passes. Bleeding complications were defined using the Common Terminology Criteria for Adverse Events (CTCAE, version 3.0) established by the National Cancer Institute.
Among the 15,181 percutaneous core biopsies performed during the study period, 70 hemorrhages (0.5%) that were CTCAE grade 3 or greater were identified within 3 months of biopsy. The incidence of bleeding in patients taking aspirin within 10 days before biopsy was 0.6% (18/3,195), which was not statistically different compared with the incidence of bleeding in those not taking aspirin (52/11,986, 0.4%; p = 0.34). The incidence of bleeding after liver biopsy was 0.5%; kidney biopsy, 0.7%; lung biopsy, 0.2%; pancreas biopsy, 1.0%; and other biopsy, 0.2%. There were significant associations between major bleeding and serum platelet count and international normalized ratio (p < 0.001), although the association between major bleeding and the size of the biopsy needle was not significant (p = 0.97).
The overall incidence of major bleeding after imaging-guided percutaneous core needle biopsy is low. Recent aspirin therapy does not appear to significantly increase the risk of such bleeding complications.
The objective of our study was to characterize the temporal and clinical manifestation of major bleeding events after biopsy to guide clinicians in the institution of appropriate surveillance.
We ...performed a retrospective review of percutaneous image-guided biopsies performed between September 1, 2005, and May 31, 2012, including 18,947 biopsy events. According to routine protocol, follow-up telephone calls were made to patients 24 hours after biopsy, and chart review was performed 3 months after biopsy. Bleeding complications were defined using the Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) established by the National Cancer Institute. In patients with a grade 3 or greater bleeding complication, a retrospective chart review was performed to characterize the details of the complication including the timing of the complication and the primary clinical presentation of the event.
Grade 3 hemorrhage was associated with 64 of 18,947 (0.3%) procedures, and there were three deaths associated with the biopsy event (0.02% or ≈ 2/10,000). Hemorrhage was most commonly associated with biopsy of a native kidney (17/1407, 1.2%). Twenty patients (31%) presented with a bleeding complication within 1 hour of biopsy. Twenty-seven patients (42%) presented within 2 hours of biopsy. Fifty-two patients (81%) presented within 24 hours, and the remaining 12 patients (19%) presented more than 24 hours after biopsy. Pain was the most common presentation of patients with bleeding complications, occurring in 39 (61%) patients.
The incidence of major bleeding after percutaneous biopsies is very low, but delayed complications occur more frequently than anticipated. Pain is the most common clinical presentation of major bleeding complications.
