Endovascular management of inferior vena cava filter (IVCF)-related chronic iliocaval thrombosis typically consists of stent placement across an obstructed IVCF; however, studies have suggested this can result in significant rates of in-stent restenosis/occlusion, possibly due to incomplete stent expansion at the IVCF implantation site. Furthermore, IVCF displacement can result in adverse events (AE), including pericaval filter component perforation. We aim to demonstrate safety/effectiveness of single-session treatment of IVCF-related chronic iliocaval thrombosis with simultaneous IVCF retrieval. From 1/2015 to 4/2018 patients with IVCF-related iliocaval thrombosis were assessed; chronicity was determined by symptoms >30 days and corroborating imaging. All patients underwent IVCF retrieval followed by recanalization with stent placement; patients with acute thrombus in the iliofemoral segments underwent pharmacomechanical thrombectomy. The edema and pain components of the Venous Clinical Severity Score (VCSS) were used to assess clinical success. Patency was evaluated at 1 month and 1 year. Filter type, dwell time, technical success, use of advanced retrieval techniques, and AEs were also assessed. Data were analyzed using a paired t-test; significance was determined at p<0.05. Twenty-five patients (20 males, median age 58 years) with 8 types of IVCF were encountered; technical success was achieved in all patients. Mean improvement in the edema subscore was 1.4 (95%CI: 1.0-1.7, p<0.01) and 0.6 (95%CI: 0.2-1.0, p<0.01) in the pain subscore; one month stent patency was maintained in 96% of patients. One year follow-up was available in 8 patients; all demonstrated patency. Median IVCF implantation time was 12.3 months (mean 41.9, range 0.8-245, SD=63.3). Advanced retrieval techniques were required for 17 patients. One major and minor AE occurred, no patients died in the study period. Single-session iliocaval recanalization with IVCF retrieval has high rates of technical and clinical success; simultaneous IVCF retrieval may result in higher rates of stent patency and avoid potential IVCF-related AE.
Purpose:The ALBI (albumin-bilirubin) grade offers a simple, evidence-based, objective, and discriminatory method of assessing liver function.In this study, we aim to evaluate the ALBI grading system as a prognostic indicator of overall survival in patients undergoing yttrium-90 radioembolization for unresectable hepatocellular carcinoma (HCC).Materials: With IRB approval, 948 HCC patients underwent radioembolization (2003)(2004)(2005)(2006)(2007)(2008)(2009)(2010)(2011)(2012)(2013)(2014)(2015)(2016).Their baseline ALBI grade was recorded and compared to Child-Pugh (CP) class.Overall survival (OS) from time of 1st radioembolization was calculated using Kaplan Meier univariate analysis for ALBI grade, BCLC, and CP class.Multivariate analyses were performed using the Cox regression hazards model to evaluate BCLC, CP, and ALBI.Results: ALBI 1, 2, and 3 grades were present in 63 (7%), 608 (64%), and 277 (29%) patients.The median OS in months (95% CI) for ALBI grades 1, 2, and 3 was 46.7 (30-47), 17.7 (16-21) and 9.1 (6.8-10.7),respectively (Po0.0001).Hazard ratios for OS for ALBI 2/3 compared to ALBI 1 were 2.7 (95%CI: 1.9-3.9)and 5.7 (95%CI: 3.8-8.5),respectively.The median OS in months (95% CI) for CP class A, B, and C was 21 (18-25), 11 (9.5-13) and 6 (4.4-16), respectively (Po0.0001).On substratification analysis, in CP A patients, ALBI grade was further able to prognosticate survival with hazard ratios for ABLI 41 of 2.7 (95% CI: 1.7 to 4.2) compared to ALBI 1 (P ¼ 0.017).In a multivariate analysis, hazard ratio for ALBI grade was 1.8 (95% CI: 1.41-2.3;Po0.0001).Hazard ratio for BCLC classification was 1.8 (95% CI: 1.67-2.06;Po0.0001), whereas that for CP was 0.9 (CI: 0.75-1.2;P ¼ 0.5431).In patients within Milan criteria, multivariate analysis showed that ALBI grade significantly affected survival with a hazard ratio of 2 (95% CI: 1.15-3.5;P ¼ 0.01) while CP class had a hazard ratio of 1.3 (95% CI: 0.7-2.5;P ¼ 0.3).Conclusions: ALBI Grade, which is an objective method to assess liver function, provides a robust prognostic indicator of overall survival and may outperform CP class in HCC patients undergoing radioembolization.
Liver-directed therapies for unresectable hepatocellular carcinoma (HCC) patients with advanced disease [Barcelona Clinic for Liver Cancer (BCLC) C] are increasingly employed. In this study, we aim to study the efficacy and prognostic indicators for BCLC C patients undergoing yttrium-90 radioembolization (Y90). With IRB approval, we searched our prospectively acquired database and included all BCLC C HCC patients that underwent Y90. The indication for BCLC C status [Eastern Cooperative Oncology Group (ECOG) performance status of 1 or 2, metastases, and/or portal vein thrombosis (PVT)] was recorded. Kaplan-Meier survival analyses were performed from the date of first Y90, censored to curative treatment, to calculate median overall survival (OS). Cox regression hazards model was used for multivariate analyses. Significance was set at P<0.05. 515 BCLC C patients were treated with Y90 with a median survival of 10.6 months (95% CI: 9.3-12.8). 189 patients (36.7%) were classified as BCLC C solely by their ECOG performance status; they had a median survival (95% CI) of 19.6 months (14.7-27). 326 patients (63.3%) were classified as BCLC C due to vascular invasion or metastases (regardless of ECOG performance status); they had an OS of 8 months (95% CI: 7.3-9) (P = 0.001). On multivariate analysis, ECOG was not found to be a statistically significant prognostic indicator of survival in BCLC C patients whereas metastasis and PVT had hazards ratios (95%CI) of 2.4 (1.8-3.1) and 3.2 (2.6-3.8), respectively (P<0.001). Radioembolization is an effective method of treating BCLC C HCC patients with median OS similar to that realized with currently allocated therapy per BCLC guidelines. Patients classified as BCLC C due to ECOG performance status alone demonstrated improved survival when compared to those presenting with PVT and/or metastases, regardless of ECOG. Hence, ECOG performance status by itself may not be a true indicator of advanced disease.
The prevailing approach to inferior vena cava filter (IVCF)-related chronic iliocaval thrombosis is stent placement across an obstructed IVCF, which can result in adverse events (AE), including penetration into adjacent structures. We aim to demonstrate safety/efficacy of single-session treatment of IVCF-related chronic iliocaval thrombosis with simultaneous IVCF retrieval. This study was approved by our IRB. Between 6/2015-9/2016, we identified 10 consecutive patients presenting for treatment of IVCF-related chronic iliocaval thrombosis; 8 were symptomatic with lower extremity edema. Patients underwent single-session IVCF retrieval with standard sheath/snare technique or advanced techniques (endobronchial forceps, loop wire technique, laser sheath) followed by recanalization with self-expanding stent placement. Patient demographics, IVCF type and dwell time, technical success, filter retrieval technique, AEs, and fluoroscopic time were recorded. First clinical follow up was obtained between 1-3 months. Ten patients (mean age 49.2 years, range 20-73, SD = 19.1) with 7 types of IVCF (Denali, Eclipse, Option, Tulip, Greenfield, ALN and Celect) were encountered. Mean filter dwell time was 30.6 months (range 1-141.2, SD = 42.6). Technical success of retrieval and iliocaval recanalization was achieved in all patients. Advanced techniques were required for 7 procedures. Mean fluoroscopic time was 44.2 min (range 31.2-59.8, SD = 8.7). One AE occurred with asymptomatic, self-limited IVC perforation during IVCF retrieval. At 1 month, all 8 symptomatic patients had objective resolution of edema. Follow-up CT venography was available between 1-3 months post procedure for 9 patients, with 1 patient having an additional CT follow-up at 1 year; all demonstrated patency. Same day iliocaval recanalization with simultaneous IVCF retrieval appears to be safe and durable in patients with IVCF-related chronic iliocaval thrombosis and may prevent long-term sequelae related to chronic venous stasis changes and IVCF-related AEs. Further data, including long-term follow-up, will be important in validating this approach.
The ALBI (albumin-bilirubin) grade offers a simple, evidence-based, objective, and discriminatory method of assessing liver function. In this study, we aim to evaluate the ALBI grading system as a prognostic indicator of overall survival in patients undergoing yttrium-90 radioembolization for unresectable hepatocellular carcinoma (HCC). With IRB approval, 948 HCC patients underwent radioembolization (2003-2016). Their baseline ALBI grade was recorded and compared to Child-Pugh (CP) class. Overall survival (OS) from time of 1st radioembolization was calculated using Kaplan Meier univariate analysis for ALBI grade, BCLC, and CP class. Multivariate analyses were performed using the Cox regression hazards model to evaluate BCLC, CP, and ALBI. ALBI 1, 2, and 3 grades were present in 63 (7%), 608 (64%), and 277 (29%) patients. The median OS in months (95% CI) for ALBI grades 1, 2, and 3 was 46.7 (30-47), 17.7 (16-21) and 9.1 (6.8-10.7), respectively (P<0.0001). Hazard ratios for OS for ALBI 2/3 compared to ALBI 1 were 2.7 (95%CI: 1.9-3.9) and 5.7 (95%CI: 3.8-8.5), respectively. The median OS in months (95% CI) for CP class A, B, & C was 21 (18-25), 11 (9.5-13) and 6 (4.4-16), respectively (P<0.0001). On sub-stratification analysis, in CP A patients, ALBI grade was further able to prognosticate survival with hazard ratios for ABLI >1 of 2.7 (95% CI: 1.7 to 4.2) compared to ALBI 1 (P = 0.017). In a multivariate analysis, hazard ratio for ALBI grade was 1.8 (95% CI: 1.41-2.3; P<0.0001). Hazard ratio for BCLC classification was 1.8 (95% CI: 1.67-2.06; P<0.0001), whereas that for CP was 0.9 (CI: 0.75-1.2; P = 0.5431). In patients within Milan criteria, multivariate analysis showed that ALBI grade significantly affected survival with a hazard ratio of 2 (95% CI: 1.15-3.5; P = 0.01) while CP class had a hazard ratio of 1.3 (95% CI: 0.7-2.5; P = 0.3). ALBI Grade, which is an objective method to assess liver function, provides a robust prognostic indicator of overall survival and may outperform CP class in HCC patients undergoing radioembolization.
To evaluate operative and post-operative outcomes in patients who underwent surgical resection following yttrium-90 radioembolization (Y90) for hepatocellular carcinoma (HCC). With IRB approval, consecutive HCC patients since 2003 that underwent surgical resection following Y90 were evaluated. Lobar parenchymal volumes were calculated from pre/post-Y90 imaging. Pathologic necrosis was evaluated in the resected tumor. Laboratory toxicity was assessed using CTCAE v4.0. Survival was analyzed using Kaplan-Meier. We also assessed serum phosphorus as a post-surgical biomarker for hypertrophy. 30 patients had Y90 prior to surgical resection [right lobectomy (N = 17, 57%)/tri-segmentectomy (N = 6, 20%)/partial hepatectomy (N = 7, 23%)]. Median time from first Y90 to resection was 2.9 months (95%CI: 2.1-4.1). Contralateral (to Y90 treatment) hepatic lobe volumes increased from a median (CI) of 564 cc (428-635) to 674 cc (563-728) (P<0.0001). Median hospital stay post resection was 3 days (range: 2-10). One month post-Y90, 33% had grade 1 ALT toxicity, 27% and 10% had grade 1 and 2 AST toxicity, 10% had grade 1 albumin toxicity, 50% and 7% had grade 1 and grade 2 alkaline phosphatase toxicity, and 13%, 3%, and 3% had grade 1, 2, and 3 bilirubin toxicity, respectively. Total bilirubin decreased from a median of 1.3 mg/dl (CI:1-2.4) on postoperative day (POD) 1 to 0.75 mg/dl (CI:0.52-0.88; P<0.001). Complete, >50%, and <50% pathologic necrosis was identified in 10(33%), 11(37%), and 9(30%) of resected tumors, respectively. Survival rates (CI) at 1 and 3 years were 94% (81-99) and 81% (52-99), respectively. Serum phosphorus level increased from a POD 1 median of 2.5 mg/dl (CI:2-2.9) to a median of 3.2 mg/dl (CI:3-3.6; P = 0.02) on POD 7. Pre-resection Y90 appears to facilitate safe resection with favorable post-operative outcomes. Y90 led to a significant increase in contralateral lobe volume prior to resection. Given the lack of hypophosphatemia post-resection, we hypothesize that maximal hypertrophy has occurred after Y90 but prior to surgery. Phosphorus level should be considered as a surrogate of hypertrophy in future studies.
The aim of this study is to report outcomes for patients with unresectable hepatocellular carcinoma (HCC) who received yttrium-90 radioembolization (Y90) and then underwent orthotopic liver transplantation (OLT). With IRB approval, we included all consecutive HCC patients who underwent OLT following Y90. Median overall survival (OS) and recurrence free survival (RFS) was calculated using Kaplan Meier statistics for univariate analyses from the date of OLT. Cox regression model was used for multivariate analysis. Statistical significance was set at P<0.05. 151 patients underwent OLT following Y90. Median time from Y90 to OLT was 6.6 months (95% CI: 6.1-7.9): 7.2 months (6.2-8.5), 6.6 months (5.5-8.2), and 3.7 months (1.5-7.93) for CP A, B, and C patients, respectively. Median OS (95%CI) from OLT was 10 years (6.9-10). 5 year OS probability was 75%. Recurrence rate was 13% (N = 20) with a median RFS (95% CI) of 10 years (6.7-10). 5 year RFS probability was 70%. 112 (74%) patients were within the Milan criteria before Y90 whereas 39 (26%) were beyond Milan criteria. The median RFS (95% CI) using univariate analysis for patients within compared to patients beyond Milan criteria was 119.6 months (79-not reached) and 79 months (37-87), respectively (P = 0.2). 11 (7%) patients had PVT before Y90 with a median RFS of 32 months (95% CI: 13.6-32). On multivariate analyses, a baseline AFP value >200 ng/mL was found to be the only significant prognostic indicator for recurrence free survival (Hazards Ratio: 2.3; 95% CI: 1.1-4.7; P = 0.016). HCC patients treated with Y90 followed by OLT demonstrate favorable OS and RFS, with the median approaching 10 years from OLT. No statistically significant difference in post-OLT outcomes was identified in patients within and beyond Milan criteria at time of Y90. Elevated baseline AFP value is a significant prognostic indicator for RFS. These outcomes are comparable to patients transplanted for non-malignant indications.
To report long-term outcomes of yttrium-90 radioembolization for hepatocellular carcinoma (HCC). Patients with HCC (N = 948) were treated with radioembolization as part of a single-center, prospective, longitudinal cohort study (2003-2016). Retrospective chart and imaging review was performed and patients were staged using BCLC criteria (without ECOG). Overall survival (OS) was estimated after censoring to surgical resection or orthotopic liver transplantation (OLT) using Kaplan Meier survival analysis. Multivariate analysis was performed using the Cox regression model and hazards ratios (HR) were calculated. 375 (39%), 208 (22%), 327 (34%), and 38 (5%) patients were BCLC A, B, C, and D, respectively. 151 (16%) received OLT with a median time to OLT of 6.6 months (range: 0.3–34). 30 (3%) patients underwent hepatic resection within median time to resection of 2.9 months (95% CI: 0.9-25.5). Median OS (months) (95% CI) for BCLC A/B/C/D were [34.4(29-47.3)/15.7(13.8-21.4)/8(7.3-9)/6(4.4-16)]. Median OS (95% CI) for patients within Milan criteria was 37.2 months (29.1- 70.2). Median OS (95%CI) for Child-Pugh A (N = 188) within Milan criteria (N = 188) is 67.5 months (37.2-80.2) (5-year survival probability of 54%). 272 (29%) patients had portal vein thrombosis with a median OS of 7 months (95% CI: 5.8-7.8) while 84 (9%) patients had metastases with a median OS of 7.2 months (95% CI: 5.4-8.6). On multivariate analysis, baseline AFP >200 ng/mL (HR: 1.6; 95% CI: 1.4-2), ALBI grade (HR 1.7; 95% CI: 1.5-2.0), BCLC (HR 1.4; 95% CI: 1.2-1.6), PVT (HR: 1.8; 95% CI: 1.4-2.2) and metastases (HR: 1.9; 95% CI: 1.4-2.5) were statistically significant prognosticators of survival (P<0.0001). Radioembolization results in survival outcomes that are affected by the baseline characteristics. Patients with preserved liver function (CP A) within Milan criteria demonstrate improved long-term outcomes with a median survival of 67.5 months. This type of analysis using big data permits substratification of patients and identification of those that may benefit maximally from radioembolization.
We describe an effective surgical technique in primary repair of the spinal dura during minimally invasive spine surgery (MISS). Objective. Minimally invasive spine surgery includes the treatment of intradural lesions, and proper closure of the dura is necessary. However, primary dural closure can be difficult due to the restricted space of MIS retractors and the availability of appropriate surgical instrumentation. Methods. We describe the use of a needle already used in the pediatric neurosurgical arena that can facilitate easier and safer closure of spinal dura through MISS retractors in two illustrative intradural cases. Results and Discussion. The primary dural closure technique is described and patient demographics are included. The instruments specifically used for the intradural closure through MIS retractor systems include (1) 4-0 Surgilon braided nylon (Covidien, Dublin, Ireland) with a CV-20 taper 1/2 circle, 10 mm diameter needle; (2) Scanlan (Saint Paul, MN, USA) dura closure set. Conclusion. Successful primary dural repair can be performed on primary and incidental durotomies during minimally invasive spinal surgery. We describe the novel use of a 10 mm diameter needle to help surgeons safely and efficiently close the dura with more ease than previously described.