This column alerts SIR members to abstracts that may have an impact on their practice and how they converse with referring clinicians. If you would like to suggest abstracts you feel should be included, email us at gandhi@baptisthealth.net or suvranu.ganguli@bmc.org.
The key takeaways accompanying each abstract were generated using human-assisted AI.
Transcatheter arterialization of deep veins in chronic limb-threatening ischemia
N Engl J Med. 2023 Mar 30;388(13):1171-1180. doi: 10.1056/NEJMoa2212754.
Shishehbor MH, Powell RJ, Monter-Baker MF, Dua A, Martinez-Trabal JL, Bunte MC, Lee AC, Mugglin AS, Mills JL, Farber A, Clair DG, PROMISE II Investigators
Background: Approximately 20% of patients with chronic limb-threatening ischemia have no revascularization options, leading to above-ankle amputation. Transcatheter arterialization of the deep veins is a percutaneous approach that creates an artery-to-vein connection for delivery of oxygenated blood by means of the venous system to the ischemic foot to prevent amputation.
Methods: We conducted a prospective, single-group, multicenter study to evaluate the effect of transcatheter arterialization of the deep veins in patients with nonhealing ulcers and no surgical or endovascular revascularization treatment options. The composite primary end point was amputation-free survival (defined as freedom from above-ankle amputation or death from any cause) at 6 months, as compared with a performance goal of 54%. Secondary end points included limb salvage, wound healing and technical success of the procedure.
Results: We enrolled 105 patients who had chronic limb-threatening ischemia and were of a median age of 70 years (interquartile range, 38 to 89). Of the patients enrolled, 33 (31.4%) were women and 45 (42.8%) were Black, Hispanic or Latino. Transcatheter arterialization of the deep veins was performed successfully in 104 patients (99.0%). At 6 months, 66.1% of the patients had amputation-free survival. According to Bayesian analysis, the posterior probability that amputation-free survival at 6 months exceeded a performance goal of 54% was 0.993, which exceeded the prespecified threshold of 0.977. Limb salvage (avoidance of above-ankle amputation) was attained in 67 patients (76.0% by Kaplan-Meier analysis). Wounds were completely healed in 16 of 63 patients (25%) and were in the process of healing in 32 of 63 patients (51%). No unanticipated device-related adverse events were reported.
Conclusions: We found that transcatheter arterialization of the deep veins was safe and could be performed successfully in patients with chronic limb-threatening ischemia and no conventional surgical or endovascular revascularization treatment options. (Funded by LimFlow; PROMISE II study ClinicalTrials.gov number, NCT03970538.)
Key takeaways:
- Transcatheter arterialization of deep veins is a percutaneous approach that creates an artery-to-vein connection for delivering oxygenated blood to the ischemic foot to prevent amputation.
- The study evaluated the effect of transcatheter arterialization of deep veins in patients with chronic limb-threatening ischemia and no surgical or endovascular revascularization treatment options. The results showed that 66.1% of patients had amputation-free survival at 6 months, exceeding the prespecified threshold of 54%.
- The study concluded that transcatheter arterialization of deep veins was safe and could be performed successfully in patients with chronic limb-threatening ischemia and no conventional surgical or endovascular revascularization treatment options.
Postoperative adjuvant hepatic arterial infusion chemotherapy with FOLOX in hepatocellular carcinoma with microvascular invasion: A multicenter, Phase III, randomized study
J Clin Oncol. 2023 Apr 1;41(10):1898-1908. doi: 10.1200/JCO.22.01142. Epub 2022 Dec 16.
Li SH, et al
Purpose: To report the efficacy and safety of postoperative adjuvant hepatic arterial infusion chemotherapy (HAIC) with 5-fluorouracil and oxaliplatin (FOLFOX) in hepatocellular carcinoma (HCC) patients with microvascular invasion (MVI).
Patients and methods: In this randomized, open-label, multicenter trial, histologically confirmed HCC patients with MVI were randomly assigned (1:1) to receive adjuvant FOLFOX-HAIC (treatment group) or routine follow-up (control group). The primary end point was disease-free survival (DFS) by intention-to-treat (ITT) analysis while secondary end points were overall survival, recurrence rate and safety.
Results: Between June 2016 and August 2021, a total of 315 patients (ITT population) at five centers were randomly assigned to the treatment group (n = 157) or the control group (n = 158). In the ITT population, the median DFS was 20.3 months (95% CI, 10.4 to 30.3) in the treatment group versus 10.0 months (95% CI, 6.8 to 13.2) in the control group (hazard ratio, 0.59; 95% CI, 0.43 to 0.81; P = .001). The overall survival rates at 1 year, 2 years and 3 years were 93.8% (95% CI, 89.8 to 98.1), 86.4% (95% CI, 80.0 to 93.2) and 80.4% (95% CI, 71.9 to 89.9) for the treatment group and 92.0% (95% CI, 87.6 to 96.7), 86.0% (95% CI, 79.9 to 92.6) and 74.9% (95% CI, 65.5 to 85.7) for the control group (hazard ratio, 0.64; 95% CI, 0.36 to 1.14; P = .130), respectively. The recurrence rates were 40.1% (63/157) in the treatment group and 55.7% (88/158) in the control group. Majority of the adverse events were grade 0-1 (83.8%), with no treatment-related death in both groups.
Conclusion: Postoperative adjuvant HAIC with FOLFOX significantly improved the DFS benefits with acceptable toxicities in HCC patients with MVI.
Key takeaways:
- Postoperative adjuvant hepatic arterial infusion chemotherapy (HAIC) with FOLFOX improved disease-free survival (DFS) benefits in hepatocellular carcinoma (HCC) patients with microvascular invasion (MVI) compared to routine follow-up.
- The overall survival rates were similar between the treatment group and the control group, but the treatment group had lower recurrence rates than the control group.
- The treatment was generally well-tolerated, with mostly grade 0-1 adverse events and no treatment-related deaths reported in either group.
Cancer-specific mortality after cryoablation vs heat-based thermal ablation in T1a renal cell carcinoma
J Urol. 2023 Jan;209(1):81-88. doi: 10.1097/JU.0000000000002984. Epub 2022 Nov 28.
Sorce G, Hoeh B, Hohenhorst L, Panunzio A, Tappero S, Tian Z, Kokorovic A, Larcher A, Capitanio U, Tilki D, Terrone C, Chun FKH, Antonelli A, Saad F, Shariat SF, Montorsi F, Briganti A, Karakiewicz PI.
Purpose: Guidelines suggest less favorable cancer control outcomes for local tumor destruction in T1a renal cell carcinoma patients with tumor size 3.1–4 cm. We compared cancer-specific mortality between cryoablation vs. heat-based thermal ablation in patients with tumor size 3.1–4 cm, as well as in patients with tumor size ≤3 cm.
Materials and methods: Within the Surveillance, Epidemiology, and End Results database (2004–2018), we identified patients with clinical T1a stage renal cell carcinoma treated with cryoablation or heat-based thermal ablation. After up to 2:1 ratio propensity score matching between patients treated with cryoablation vs. heat-based thermal ablation, we addressed cancer-specific mortality relying on competing risks regression models, adjusted for other-cause mortality and other covariates (age, tumor size, tumor grade and histological subtype).
Results: Of 1,468 assessable patients with tumor size 3.1–4 cm, 1,080 vs. 388 were treated with cryoablation vs heat-based thermal ablation, respectively. After up to 2:1 propensity score matching that resulted in 757 cryoablations vs 388 heat-based thermal ablations, in multivariable competing risks regression models, heat-based thermal ablation was associated with higher cancer-specific mortality (HR:2.02, P < .001), relative to cryoablation. Of 4,468 assessable patients with tumor size ≤3 cm, 3,354 vs 1,114 were treated with cryoablation vs heat-based thermal ablation, respectively. After up to 2:1 propensity score matching that resulted in 2,217 cryoablations vs 1,114 heat-based thermal ablations, in multivariable competing risks regression models, heat-based thermal ablation was not associated with higher cancer-specific mortality (HR:1.13, P = .5) relative to cryoablation.
Conclusions: Our findings corroborated that in cT1a patients with tumor size 3.1–4 cm, cancer-specific mortality is twofold higher after heat-based thermal ablation vs cryoablation. Conversely, in patients with tumor size ≤3 cm either ablation technique is equally valid. These findings should be considered at clinical decision making and informed consent.
Key takeaways:
- The study compared cancer-specific mortality between cryoablation and heat-based thermal ablation in patients with T1a renal cell carcinoma. Cryoablation was found to be associated with lower cancer-specific mortality compared to heat-based thermal ablation in patients with tumor size 3.1–4 cm.
- The study also found that in patients with tumor size ≤3 cm, both cryoablation and heat-based thermal ablation techniques were equally valid and there was no significant difference in cancer-specific mortality between the two techniques.
- The study used the Surveillance, Epidemiology, and End Results (SEER) database from 2004–2018 and conducted up to 2:1 ratio propensity score matching between patients treated with cryoablation vs heat-based thermal ablation. The results highlight the importance of considering these findings in clinical decision making and informed consent.
Association between hemorrhage control interventions and mortality in U.S. trauma patients with hemodynamically unstable pelvic fractures
JAMA Surg. 2023 Jan 1;158(1):63–71. doi: 10.1001/jamasurg.2022.5772.
Anand T, El-Qawaqzeh, Nelson A, Hosseinpour H, Ditillo M, Gries L, Castanon L, Joseph B
Importance: Management of hemodynamically unstable pelvic fractures remains a challenge. Hemostatic interventions are used alone or in combination. There is a paucity of data on the association between the pattern of hemorrhage control interventions and outcomes after a severe pelvic fracture.
Objective: To characterize clinical outcomes and study the patterns of hemorrhage control interventions in hemodynamically unstable pelvic fractures.
Design, setting, and participants: In this cohort study, a retrospective review was performed of data from the 2017 American College of Surgeons Trauma Quality Improvement Program database, a national multi-institutional database of trauma patients in the United States. Adult patients (aged ≥18 years) with pelvic fractures who received early transfusions (≥4 units of packed red blood cells in 4 hours) and underwent intervention for pelvic hemorrhage control were identified. Use and order of preperitoneal pelvic packing (PP), pelvic angioembolization (AE) and resuscitative endovascular balloon occlusion of the aorta (REBOA) in zone 3 were examined and compared against the primary outcome of mortality. The associations between intervention patterns and mortality, complications and 24-hour transfusions were further examined by backward stepwise regression analyses. Data analyses were performed in September 2021.
Main outcomes and measures: Primary outcomes were rates of 24-hour, emergency department and in-hospital mortality. Secondary outcomes were major in-hospital complications.
Results: A total of 1396 patients were identified. Mean (SD) age was 47 (19) years, 975 (70%) were male, and the mean (SD) lowest systolic blood pressure was 71 (25) mm Hg. The median (IQR) Injury Severity Score was 24 (14–34), with a 24-hour mortality of 217 patients (15.5%), ED mortality of 10 patients (0.7%), in-hospital mortality of 501 patients (36%), and complication rate of 574 patients (41%). Pelvic AE was the most used intervention (774 [55%]), followed by preperitoneal PP (659 [47%]) and REBOA zone 3 (126 [9%]). Among the cohort, 1236 patients (89%) had 1 intervention, 157 (11%) had 2 interventions, and 3 (0.2%) had 3 interventions. On regression analyses, only pelvic AE was associated with a mortality reduction (odds ratio [OR], 0.62; 95% CI, 0.47 to 0.82; P < .001). Preperitoneal PP was associated with increased odds of complications (OR, 1.39; 95% CI, 1.07 to 1.80; P = .01). Increasing number of interventions was associated with increased 24-hour transfusions (β = +5.4; 95% CI, +3.5 to +7.5; P < .001) and mortality (OR, 1.57; 95% CI, 1.05 to 2.37; P = .03), but not with complications.
Conclusions and relevance: This study found that among patients with pelvic fracture who received early transfusions and at least 1 invasive pelvic hemorrhage control intervention, more than 1 in 3 died, despite the availability of advanced hemorrhage control interventions. Only pelvic AE was associated with a reduction in mortality.
Key takeaways:
- Hemodynamically unstable pelvic fractures remain a challenging condition to manage, and there is a paucity of data on the association between the pattern of hemorrhage control interventions and outcomes.
- Among patients with pelvic fractures who received early transfusions and at least one invasive pelvic hemorrhage control intervention, more than 1 in 3 died, despite the availability of advanced hemorrhage control interventions.
- Pelvic angioembolization was the most commonly used intervention, and it was associated with a reduction in mortality. However, preperitoneal pelvic packing was associated with an increased risk of complications, and an increasing number of interventions was associated with increased 24-hour transfusions and mortality, but not complications.
