Pulsed field ablation with the pentaspline catheter compared with cryoablation for the treatment of paroxysmal atrial fibrillation in the UK NHS: a cost-comparison analysis.

OBJECTIVES: Pulsed field ablation (PFA) is a promising new ablation modality for the treatment of atrial fibrillation (AF) that has recently become available in the UK National Health Service (NHS). We provide the first known economic evaluation of the technology. METHODS: A cost-comparison model was developed to compare the expected 12-month costs of treating AF using the pentaspline PFA catheter compared with cryoablation for a single hypothetical patient. Model parameters were based on a recent cost-effectiveness analysis by the National Institute for Health and Care Excellence where possible or published literature otherwise. Deterministic sensitivity, scenario and threshold analyses were conducted. RESULTS: Costs for a single patient treated with PFA were -3% (-£343) less over 12 months than those who received treatment with cryoablation. PFA was associated with 16% higher catheter costs but repeat ablation costs were over 50% less, driven by a reduction in repeat ablations required. Costs of managing complications were -£211 less in total for PFA compared with cryoablation. CONCLUSIONS: Routine adoption of PFA with the pentaspline PFA catheter looks to be as affordable for the NHS as current treatment alternative cryoablation.

Sensor-Based Measurement Method to Support the Assessment of Robot-Assisted Radiofrequency Ablation.

Digital surgery technologies, such as interventional robotics and sensor systems, not only improve patient care but also aid in the development and optimization of traditional invasive treatments and methods. Atrial Fibrillation (AF) is the most common cardiac arrhythmia with critical clinical relevance today. Delayed intervention can lead to heart failure, stroke, or sudden cardiac death. Although many advances have been made in the field of radiofrequency (RF) catheter ablation (CA), it can be further developed by incorporating sensor technology to improve its efficacy and safety. Automation can be utilized to shorten the duration of RF ablation, provided that the interactions between the tissue and the RF tools are well understood and adequately modeled. Further research is needed to develop the optimal catheter design. This paper describes the systematic methodology developed to support robot-assisted RF CA characterization measurements. The article describes the custom instruments developed for the experiments, particularly the contact force limiter, the measurement procedure, and the evaluation of the results, as enablers for new results. The aim was to establish an objective, repeatable, robust measurement method and adjacent procedure.

Editor's Choice - Short Term Cost Effectiveness of Radiofrequency Ablation and High Ligation and Stripping for Great Saphenous Vein Incompetence.

OBJECTIVE: Superficial venous incompetence (SVI) is a common disease that causes significant quality of life (QoL) impairment. There is a need for more health economic evaluations of SVI treatment. The aim of this study was to perform a cost effectiveness analysis in patients with great saphenous vein (GSV) incompetence comparing radiofrequency ablation (RFA), high ligation and stripping (HL/S), and no treatment or conservative treatment with one year follow up. METHODS: Randomised controlled trial economic analysis from an ongoing trial; 143 patients (156 limbs) with GSV incompetence (CEAP clinical class 2 - 6) were included. Treatment was performed with RFA or HL/S. Follow up was performed up to one year using duplex ultrasound, revised venous clinical severity score (r-VCSS), Aberdeen Varicose Vein Questionnaire (AVVQ), and EuroQol-5D-3L (EQ-5D-3L). RESULTS: Seventy-eight limbs were treated with RFA and HL/S respectively. No treatment or conservative treatment was assumed to have zero in treatment cost and no treatment benefit. In the RFA group, one limb had reflux in the GSV after one month and three limbs after one year. In HL/S, two limbs had remaining reflux in the treated area at one month and one year. Both disease severity (r-VCSS, p = .004) and QoL (AVVQ, p = .021 and EQ-5D-3L, p = .028) were significantly improved over time. The QALY gain was 0.21 for RFA and 0.17 for HL/S. The cost per patient was calculated as €1 292 for RFA and €2 303 for HL/S. The cost per QALY (compared with no treatment or conservative treatment) was €6 155 for RFA and €13 549 for HL/S. With added cost for days absent from work the cost per QALY was €7 358 for RFA and €24 197 for HL/S. The cost per QALY for both methods was well below the threshold suggested by Swedish National Board of Health. CONCLUSION: RFA is more cost effective than HL/S and no treatment or conservative treatment at one year follow up.

Cost-utility of VISITAG SURPOINT in catheter ablation of atrial fibrillation.

BACKGROUND: Clinical studies have demonstrated the safety, efficacy, and efficiency of VISITAG SURPOINT® (VS), which provides important lesion markers during catheter ablation (CA) of atrial fibrillation (AF). The present study evaluated the cost-effectiveness of CA with VS compared to CA without VS in AF from the publicly-funded German and Belgium healthcare perspectives. METHODS: We constructed a two-stage cost utility model that included a decision tree to simulate clinical events, costs, and utilities during the first year after the index procedure and a Markov model to simulate transitions between health states throughout a patient's lifetime. Model inputs included published literature, a meta-analysis of randomized controlled trials AF outcomes, and publicly available administrative data on costs. Deterministic and probabilistic sensitivity analyses were conducted to determine the robustness of the model. RESULTS: CA with VS was associated with lower per patient costs vs CA without VS (Germany: €3295 vs. €3936, Belgium: €3194 vs. €3814) and similar quality-adjusted life-years (QALYs) per patient (Germany: 5.35 vs. 5.34, Belgium: 5.68 vs. 5.67). CA with VS was the dominant ablation strategy (incremental cost-effectiveness ratios: Germany: €-52,455/QALY, Belgium: €-50,676/QALY). The model results were robust and not highly sensitive to variation to individual parameters with regard to QALYs or costs. Freedom from AF and procedure time had the greatest impact on model results, highlighting the importance of these outcomes in ablation. CONCLUSIONS: CA with VS resulted in cost savings and QALY gains compared to CA without VS, supporting the increased adoption of VS in CA in Germany and Belgium.

Catheter ablation for supraventricular tachycardia and health resource utilization and expenditures: A propensity-matched cohort study.

BACKGROUND: Few data are available regarding temporal patterns of health resource utilization (HRU) and expenditures among patients undergoing catheter ablation for paroxysmal supraventricular tachycardia (PSVT). This study aimed to describe expenditures and HRU in patients with PSVT who underwent catheter ablation compared to a matched cohort of patients on medical therapy alone. METHODS: Using a large US administrative database, we identified adult patients (age 18 to 65 years) with a new PSVT diagnosis between 2008 and 2016. Propensity-score matching was used to assemble a PSVT cohort treated with ablation or medical therapy alone (N = 2556). Longitudinal trends in HRU and expenditures in the 3-years preceding and following PSVT diagnosis were compared. RESULTS: There were no significant differences in expenditures between groups except within the first year after PSVT diagnosis: $48,004 ablation vs. $17,560 medical therapy (p < 0.001). This difference was driven by procedural expenditures, where the mean cost of catheter ablation was $32,057 ± SD 26,737. In Years 2 and 3 post-ablation, HRU and expenditures decreased to the levels associated with the medical therapy group, although fewer ablation patients required any prescription for beta-blockers, calcium channel blockers, or anti-arrhythmic drugs (32% ablation vs. 42% medical therapy group, p < 0.001). CONCLUSION: Catheter ablation reduces medication burden in PSVT, yet health resource use and expenditures were similar beyond 2 years post-ablation when compared to PSVT patients on medical therapy alone. Additional studies are required to better understand drivers of these sustained health expenditures, and barriers to achieving cost-savings for a potentially curative procedure.

Directional microwave ablation in spine: experimental assessment of computational modeling.

BACKGROUND: Despite the theoretical advantages of treating metastatic bone disease with microwave ablation (MWA), there are few reports characterizing microwave absorption and bioheat transfer in bone. This report describes a computational modeling-based approach to simulate directional microwave ablation (dMWA) in spine, supported by ex vivo and pilot in vivo experiments in porcine vertebral bodies. MATERIALS AND METHODS: A 3D computational model of microwave ablation within porcine vertebral bodies was developed. Ex vivo porcine vertebra experiments using a dMWA applicator measured temperatures approximately 10.1 mm radially from the applicator in the direction of MW radiation (T1) and approximately 2.4 mm in the contra-lateral direction (T2). Histologic assessment of ablated ex vivo tissue was conducted and experimental results compared to simulations. Pilot in vivo experiments in porcine vertebral bodies assessed ablation zones histologically and with CT and MRI. RESULTS: Experimental T1 and T2 temperatures were within 3-7% and 11-33% of simulated temperature values. Visible ablation zones, as indicated by grayed tissue, were smaller than those typical in other soft tissues. Posthumous MRI images of in vivo ablations showed hyperintensity. In vivo experiments illustrated the technical feasibility of creating directional microwave ablation zones in porcine vertebral body. CONCLUSION: Computational models and experimental studies illustrate the feasibility of controlled dMWA in bone tissue.

Three-Dimensional Margin as a Predictor of Local Tumor Progression after Microwave Ablation: Intraprocedural versus 4-8-Week Postablation Assessment.

PURPOSE: To evaluate the prognostic accuracy of intraprocedural and 4-8-week (current standard) post-microwave ablation zone (AZ) and margin assessments for prediction of local tumor progression (LTP) using 3-dimensional (3D) software. MATERIALS AND METHODS: Data regarding 100 colorectal liver metastases (CLMs) in 75 patients were collected from 2 prospective fluorodeoxyglucose positron emission tomography (PET)/computed tomography (CT)-guided microwave ablation (MWA) trials. The target CLMs and theoretical 5- and 10-mm margins were segmented and registered intraprocedurally and at 4-8 weeks after MWA contrast-enhanced CT (or magnetic resonance [MR] imaging) using the same methodology and 3D software. Tumor and 5- and 10-mm minimal margin (MM) volumes not covered by the AZ were defined as volumes of insufficient coverage (VICs). The intraprocedural and 4-8-week post-MWA VICs were compared as predictors of LTP using receiver operating characteristic curve analysis. RESULTS: The median follow-up time was 19.6 months (interquartile range, 7.97-36.5 months). VICs for 5- and 10-mm MMs were predictive of LTP at both time assessments. The highest accuracy for the prediction of LTP was documented with the intra-ablation 5-mm VIC (area under the curve [AUC], 0.78; 95% confidence interval, 0.66-0.89). LTP for a VIC of 6-10-mm margin category was 11.4% compared with 4.3% for >10-mm margin category (P < .001). CONCLUSIONS: A 3D 5-mm MM is a critical endpoint of thermal ablation, whereas optimal local tumor control is noted with a 10-mm MM. Higher AUCs for prediction of LTP were achieved for intraprocedural evaluation than for the 4-8-week postablation 3D evaluation of the AZ.

MRI non-rigid registration with tumor contraction correction for ablative margin assessment after microwave ablation of hepatocellular carcinomas.

Objective. This study aims to develop and assess a tumor contraction model, enhancing the precision of ablative margin (AM) evaluation after microwave ablation (MWA) treatment for hepatocellular carcinomas (HCCs).Approach. We utilize a probabilistic method called the coherent point drift algorithm to align pre-and post-ablation MRI images. Subsequently, a nonlinear regression method quantifies local tumor contraction induced by MWA, utilizing data from 47 HCC with viable ablated tumors in post-ablation MRI. After automatic non-rigid registration, correction for tumor contraction involves contracting the 3D contour of the warped tumor towards its center in all orientations.Main results. We evaluate the performance of our proposed method on 30 HCC patients who underwent MWA. The Dice similarity coefficient between the post-ablation liver and the warped pre-ablation livers is found to be 0.95 ± 0.01, with a mean corresponding distance between the corresponding landmarks measured at 3.25 ± 0.62 mm. Additionally, we conduct a comparative analysis of clinical outcomes assessed through MRI over a 3 month follow-up period, noting that the AM, as evaluated by our proposed method, accurately detects residual tumor after MWA.Significance. Our proposed method showcases a high level of accuracy in MRI liver registration and AM assessment following ablation treatment. It introduces a potentially approach for predicting incomplete ablations and gauging treatment success.

Intraprocedural assessment of ablation margins using computed tomography co-registration in hepatocellular carcinoma treatment with percutaneous ablation: IAMCOMPLETE study.

PURPOSE: The primary objective of this study was to determine the feasibility of ablation margin quantification using a standardized scanning protocol during thermal ablation (TA) of hepatocellular carcinoma (HCC), and a rigid registration algorithm. Secondary objectives were to determine the inter- and intra-observer variability of tumor segmentation and quantification of the minimal ablation margin (MAM). MATERIALS AND METHODS: Twenty patients who underwent thermal ablation for HCC were included. There were thirteen men and seven women with a mean age of 67.1 ± 10.8 (standard deviation [SD]) years (age range: 49.1-81.1 years). All patients underwent contrast-enhanced computed tomography examination under general anesthesia directly before and after TA, with preoxygenated breath hold. Contrast-enhanced computed tomography examinations were analyzed by radiologists using rigid registration software. Registration was deemed feasible when accurate rigid co-registration could be obtained. Inter- and intra-observer rates of tumor segmentation and MAM quantification were calculated. MAM values were correlated with local tumor progression (LTP) after one year of follow-up. RESULTS: Co-registration of pre- and post-ablation images was feasible in 16 out of 20 patients (80%) and 26 out of 31 tumors (84%). Mean Dice similarity coefficient for inter- and intra-observer variability of tumor segmentation were 0.815 and 0.830, respectively. Mean MAM was 0.63 ± 3.589 (SD) mm (range: -6.26-6.65 mm). LTP occurred in four out of 20 patients (20%). The mean MAM value for patients who developed LTP was -4.00 mm, as compared to 0.727 mm for patients who did not develop LTP. CONCLUSION: Ablation margin quantification is feasible using a standardized contrast-enhanced computed tomography protocol. Interpretation of MAM was hampered by the occurrence of tissue shrinkage during TA. Further validation in a larger cohort should lead to meaningful cut-off values for technical success of TA.

Time-Driven Activity-Based Cost Comparison of Osteoid Osteoma Ablation Techniques.

OBJECTIVE: Compare the cost of performing an osteoid osteoma ablation using cone beam CT (CBCT) with overlay fluoroscopic guidance to ablation using conventional CT (CCT) guidance and microwave ablation (MWA) to radiofrequency ablation (RFA). METHODS: An 11-year retrospective study was performed of all patients undergoing osteoid osteoma ablation. Ablation equipment included a Cool tip RFA probe (Covidien, Minneapolis, Minnesota) or a Neuwave PR MWA probe (Ethicon, Rariton, New Jersey). The room times as well as immediate recovery time were recorded for each case. Cost analysis was then performed using time-driven activity-based costing for rate-dependent variables including salaries, equipment depreciation, room time, and certain supplies. Time-independent costs included the disposable interventional radiology supplies and ablation systems. Costs were reported for each service providing care and using conventional cost accounting methods with variable and fixed expenditures. RESULTS: A total of 91 patients underwent 96 ablation procedures in either CBCT (n = 66) or CCT (n = 30) using either MWA (n = 51) or RFA (n = 45). The anesthesia induction (22.7 ± 8.7 min versus 15.9 ± 7.2 min, P < .001), procedure (64.7 ± 27.5 min versus 47.3 ± 15.3 min; P = .001), and room times (137.7 ± 33.7 min versus 103.9 ± 22.6. min; P < .001) were significantly longer for CBCT procedures. The procedure time did not differ significantly between MWA and RFA (62.1 ± 27.4 min versus 56.1 ± 23.3 min; P = .27). Multiple regression analysis demonstrated lower age (P = .046), CBCT use (P = .001), RFA use (P = .02), and nonsupine patient position (P = .01) significantly increased the total procedural cost. After controlling for these variables, the total cost of CBCT ($5,981.32 ± $523.93 versus $5,378.93 ± $453.12; P = .001) remained higher than CCT and the total cost of RFA ($5,981.32 ± $523.93 versus $5,674.43 ± $549.14; P = .05) approached a higher cost than MWA. CONCLUSION: The use of CBCT with overlay fluoroscopic guidance for osteoid osteoma ablation resulted in longer in-room times and greater cost when compared with CCT. These cost considerations should be weighed against potential radiation dose advantage of CBCT when choosing an image guidance modality. Younger age, RFA use, and nonsupine patient position additionally contributed to higher costs.

The Cost-Effectiveness of First-Line Cryoablation vs First-Line Antiarrhythmic Drugs in Canadian Patients With Paroxysmal Atrial Fibrillation.

BACKGROUND: The EARLY-AF (NCT02825979), STOP AF First (NCT03118518), and Cryo-FIRST (NCT01803438) randomised controlled trials (RCTs) demonstrated that cryoballoon pulmonary vein isolation reduces atrial fibrillation (AF) recurrence compared with antiarrhythmic drugs (AADs) in patients with symptomatic paroxysmal atrial fibrillation (PAF). The present study developed a cost-effectiveness model (CEM) of first-line cryoablation compared with first-line AADs for PAF, from the Canadian health care payer's perspective. METHODS: Data from the 3 RCTs were analysed to estimate key CEM parameters. The model structure used a decision tree for the first 12 months and a Markov model with a 3-month cycle length for the remaining lifetime time horizon. Costs were set at 2023 Canadian dollars, health benefits were expressed as quality-adjusted life years (QALYs), and both were discounted 3% annually. Probabilistic sensitivity analysis (PSA) considered parameter uncertainty. RESULTS: The statistical analysis estimated that first-line cryoablation generates a 47% reduction (P < 0.001) in the rate of AF recurrence, a 73% reduction in the rate of subsequent ablation (P < 0.001), and a 4.3% (P = 0.025) increase in health-related quality of life, compared with first-line AADs. The PSA indicates that an individual treated with first-line cryoablation accrues less costs (-$3,862) and more QALYs (0.19) compared with first-line AADs. Cryoablation is cost-saving in 98.4% of PSA iterations and has a 99.9% probability of being cost-effective at a cost-effectiveness threshold of $50,000 per QALY gained. Cost-effectiveness results were robust to changes in key model parameters. CONCLUSIONS: First-line cryoballoon ablation is cost-effective when compared with AADs for patients with symptomatic PAF.

Intraprocedural Versus Initial Follow-up Minimal Ablative Margin Assessment After Colorectal Liver Metastasis Thermal Ablation: Which One Better Predicts Local Outcomes?

OBJECTIVES: The aim of this study was to investigate the prognostic value of 3-dimensional minimal ablative margin (MAM) quantified by intraprocedural versus initial follow-up computed tomography (CT) in predicting local tumor progression (LTP) after colorectal liver metastasis (CLM) thermal ablation. MATERIALS AND METHODS: This single-institution, patient-clustered, tumor-based retrospective study included patients undergoing microwave and radiofrequency ablation between 2016 and 2021. Patients without intraprocedural and initial follow-up contrast-enhanced CT, residual tumors, or with follow-up less than 1 year without LTP were excluded. Minimal ablative margin was quantified by a biomechanical deformable image registration method with segmentations of CLMs on intraprocedural preablation CT and ablation zones on intraprocedural postablation and initial follow-up CT. Prognostic value of MAM to predict LTP was tested using area under the curve and competing-risk regression model. RESULTS: A total of 68 patients (mean age ± standard deviation, 57 ± 12 years; 43 men) with 133 CLMs were included. During a median follow-up of 30.3 months, LTP rate was 17% (22/133). The median volume of ablation zone was 27 mL and 16 mL segmented on intraprocedural and initial follow-up CT, respectively ( P < 0.001), with corresponding median MAM of 4.7 mm and 0 mm, respectively ( P < 0.001). The area under the curve was higher for MAM quantified on intraprocedural CT (0.89; 95% confidence interval [CI], 0.83-0.94) compared with initial follow-up CT (0.66; 95% CI, 0.54-0.76) in predicting 1-year LTP ( P < 0.001). An MAM of 0 mm on intraprocedural CT was an independent predictor of LTP with a subdistribution hazards ratio of 11.9 (95% CI, 4.9-28.9; P < 0.001), compared with 2.4 (95% CI, 0.9-6.0; P = 0.07) on initial follow-up CT. CONCLUSIONS: Ablative margin quantified on intraprocedural CT significantly outperformed initial follow-up CT in predicting LTP and should be used for ablation endpoint assessment.

Concomitant Treatment of Atrial Fibrillation in Isolated Coronary Artery Bypass Grafting.

BACKGROUND: Societal guidelines support concomitant management of atrial fibrillation (AF) in patients undergoing cardiac surgery. To assess real-world adoption and outcomes, this study evaluated Medicare beneficiaries with AF who underwent isolated coronary artery bypass grafting (CABG) with surgical ablation (SA) or left atrial appendage obliteration (LAAO) or both procedures in combination (SA + LAAO). METHODS: The US Centers for Medicare & Medicaid Services inpatient claims database identified all patients with AF who underwent isolated CABG from 2018 to 2020. Diagnosis-related group and International Classification of Diseases-10th revision procedure codes defined covariates for doubly robust risk adjustment. RESULTS: A total of 19,524 patients with preoperative AF who underwent isolated CABG were stratified by SA + LAAO (3475 patients; 17.8%), LAAO only (4541 patients; 23.3%), or no AF treatment (11,508 patients; 58.9%). After doubly robust risk adjustment, longitudinal analysis highlighted that concomitant AF treatment with SA + LAAO (hazard ratio [HR], 0.74; P = .049) or LAAO alone (HR, 0.75; P = . 031) was associated with a significant reduction in readmission for stroke at 3 years compared with no AF treatment. Furthermore, SA + LAAO (HR, 0.86; P = .016) but not LAAO alone (HR, 0.97; P = .573) was associated with improved survival compared with no AF treatment. Finally, SA + LAAO was associated with a superior composite outcome of freedom from stroke or death at 3 years compared with LAAO alone (HR, 0.86;, P = .033) or no AF treatment (HR, 0.81; P = .001). CONCLUSIONS: In Medicare beneficiaries with AF who underwent isolated CABG, concomitant AF treatment was associated with reduced 3-year readmission for stroke. SA + LAAO was associated with superior reduction in stroke or death at 3 years compared with LAAO alone or no AF treatment.

Percutaneous ethanol injection in thyroid nodular pathology and metastatic cervical adenopathies: A systematic review, meta-analysis and economic evaluation.

BACKGROUND: Percutaneous ethanol injection (PEI) has been shown to be a valuable treatment for thyroid nodular pathology and metastatic cervical adenopathies. OBJECTIVE: To evaluate the effectiveness, safety, and cost-effectiveness of PEI in thyroid nodular pathology and metastatic cervical adenopathies. METHODS: A systematic review (SR) using meta-analysis was conducted on the effectiveness and safety of PEI. A SR on cost-effectiveness was also performed. The SRs were conducted according to the methodology developed by the Cochrane Collaboration with reporting in accordance with the PRISMA statement. A cost-minimization analysis was carried out using a decision tree model. Assuming equal effectiveness between two minimally invasive techniques (PEI and radiofrequency ablation (RFA)), the model compared the costs of the alternatives with a horizon of six months and from the perspective of the Spanish National Health System. RESULTS: The search identified three RCTs (n=157) that evaluated PEI versus RFA in patients diagnosed with benign thyroid nodules: ninety-six patients with predominantly cystic nodules and sixty-one patients with solid nodules. No evidence was found on other techniques or thyroid nodular pathology. No statistically significant differences were observed between PEI and RFA in volume reduction (%), symptom score, cosmetic score, therapeutic success and major complications. No economic evaluations were identified. The cost-minimization analysis estimated the cost per patient of the PEI procedure at €326 compared to €4781 for RFA, which means an incremental difference of -€4455. CONCLUSIONS: There are no differences between PEI and RFA regarding their safety and effectiveness, but the economic evaluation determined that the former option is cheaper.

Percutaneous microwave ablation of hepatic tumors: is there an impact of cirrhotic liver parenchyma upon the volume and short-term assessment of the ablation zone?

OBJECTIVE: To retrospectively compare and evaluate ablation zone volume and its reduction from baseline to 1 month follow-up post-percutaneous microwave ablation (MWA) between healthy and cirrhotic liver parenchyma. METHODS: Institutional database research identified 84 patients (118 hepatic tumors) who underwent percutaneous MWA with the same system. Caudal-right lobe ratio was applied to distinguish cirrhotic (n = 51) and healthy (n = 67) group; ITK-SNAP software was used to quantify ablation zone volume. Long (LAD) and short 1 (SAD-1) and 2 (SAD-2) axis, tumor size diameter (mm) and volume (cm³) of the ablation zones were evaluated for each treated lesion in both groups at baseline (immediately post-ablation) and at 1 month follow-up. RESULTS: There was no significant difference comparing ablation zone volumes at baseline (healthy group: mean ablation volume 14.84 cm³ vs cirrhotic group: mean ablation volume 17.85 cm³, p = 0.31) and 1 month post-ablation (healthy group: mean ablation volume 9.15 cm³ vs cirrhotic group: mean ablation volume 11.58 cm³, p = 0.24). When both "healthy" and "cirrhotic" liver group were evaluated independently, there was a significant difference of ablation volumes reduction (p-value < 0.001) from baseline to 1 month follow-up. When both groups were compared based on reduction (35.12-38.34%) there was no significant difference in ablation zone volumes (p-value = 0.77). CONCLUSION: Percutaneous MWA results in ablation zones of a comparable volume in both healthy and cirrhotic liver parenchyma. Both cirrhotic and healthy liver parenchyma experience a similar significant reduction of ablation zone volume at 1 month post-therapy. ADVANCES IN KNOWLEDGE STATEMENT: This study evaluates and compares the volume of the ablation zone after MWA between healthy and cirrhotic liver parenchyma from baseline to 1 month follow-up and attempts to identify potential differences. It is the first study to demonstrate significant shrinkage of ablation volumes in healthy livers as compared to cirrhotic livers after 4 weeks of follow-up. The results of this study can help us understand the effect of MWA when applied in different backgrounds of liver parenchyma, which could lead to different treatment planning.

Study Protocol STEREOLAB: Stereotactic Liver Ablation Assisted with Intra-Arterial CT Hepatic Arteriography and Ablation Confirmation Software Assessment.

PURPOSE: This study aims to evaluate the technical efficacy and local tumor progression-free survival (LTPFS) of a standardized workflow for thermal ablation of colorectal liver metastases (CRLM) consisting of CT during hepatic arteriography (CTHA)-based imaging analysis, stereotactic thermal ablation, and computer-based software assessment of ablation margins. MATERIALS AND METHODS: This investigator initiated, single-center, single-arm prospective trial will enroll up to 50 patients (≤ 5 CRLM, Measuring ≤ 5 cm). Procedures will be performed in an angio-CT suite under general anesthesia. The primary objective is to estimate LTPFS with a follow-up of up to 2 years and secondary objectives are analysis of the impact of minimal ablative margins on LTPFS, adverse events, contrast media utilization and radiation exposure, overall oncological outcomes, and anesthesia/procedural time. Adverse events (AE) will be recorded by CTCAE (Common Toxicity Criteria for Adverse Events), and Bayesian optimal phase-2 design will be applied for major intraprocedural AE stop boundaries. The institutional CRLM ablation registry will be used as benchmark for comparative analysis with the historical cohort. DISCUSSION: The STEREOLAB trial will introduce a high-precision and standardized thermal ablation workflow for CRLM consisting of CT during hepatic arteriography imaging, stereotactic guidance, and ablation confirmation. Trial Registration ClinicalTrials.gov identifier: (NCT05361551).

Time-Driven Activity-Based Cost Comparison of Thyroid Lobectomy and Radiofrequency Ablation.

OBJECTIVE: Radiofrequency ablation (RFA) of benign thyroid nodules has gained traction for its therapeutic effectiveness, thyroid function preservation, and minimally invasive nature. While a growing body of evidence reports positive outcomes from thyroid RFA, financial comparisons between both procedures remain limited. This analysis aims to more accurately measure the direct cost of thyroid RFA in comparison to thyroid lobectomy. STUDY DESIGN: Bottom-up financial cost analysis. SETTING: Tertiary endocrine head and neck surgery center. METHODS: Time-driven activity-based costing was utilized to obtain unit-based cost estimates. The care cycles for thyroid lobectomy and RFA were defined, and process maps were developed comprising all personnel and work in the care cycle. Time estimates were calculated for all personnel involved, and public government data were used to obtain capacity cost rates for each component of the care cycle. Consumable supply and overhead costs were obtained for both procedures, and overall costs were compared. RESULTS: For thyroid lobectomy, total personnel costs were $1087.97, consumable supplies were $942.68, and overhead costs $17,199.10. For thyroid nodule RFA performed in an office setting, the total personnel cost calculated was $379.90, consumable supplies $1315.28, and overhead $7031.20. Overall, the total cost for thyroid lobectomy was $19,229.75 compared to $8726.38 for RFA. CONCLUSION: In-office thyroid nodule RFA is associated with lower direct costs than thyroid lobectomy, and overhead is the greatest cost driver for both procedures. If clinical and patient-centered outcomes are comparable, then RFA may provide higher value for appropriately selected patients.

Efficacy of fusion imaging for immediate post-ablation assessment of malignant liver neoplasms: A systematic review.

BACKGROUND: Percutaneous thermal ablation has become the preferred therapeutic treatment option for liver cancers that cannot be resected. Since ablative zone tissue changes over time, it becomes challenging to determine therapy effectiveness over an extended period. Thus, an immediate post-procedural evaluation of the ablation zone is crucial, as it could influence the need for a second-look treatment or follow-up plan. Assessing treatment response immediately after ablation is essential to attain favorable outcomes. This study examines the efficacy of image fusion strategies immediately post-ablation in liver neoplasms to determine therapeutic response. METHODOLOGY: A comprehensive systematic search using PRISMA methodology was conducted using EMBASE, MEDLINE (via PUBMED), and Cochrane Library Central Registry electronic databases to identify articles that assessed the immediate post-ablation response in malignant hepatic tumors with fusion imaging (FI) systems. The data were retrieved on relevant clinical characteristics, including population demographics, pre-intervention clinical history, lesion characteristics, and intervention type. For the outcome metrics, variables such as average fusion time, intervention metrics, technical success rate, ablative safety margin, supplementary ablation rate, technical efficacy rate, LTP rates, and reported complications were extracted. RESULTS: Twenty-two studies were included for review after fulfilling the study eligibility criteria. FI's immediate technical success rate ranged from 81.3% to 100% in 17/22 studies. In 16/22 studies, the ablative safety margin was assessed immediately after ablation. Supplementary ablation was performed in 9 studies following immediate evaluation by FI. In 15/22 studies, the technical effectiveness rates during the first follow-up varied from 89.3% to 100%. CONCLUSION: Based on the studies included, we found that FI can accurately determine the immediate therapeutic response in liver cancer ablation image fusion and could be a feasible intraprocedural tool for determining short-term post-ablation outcomes in unresectable liver neoplasms. There are some technical challenges that limit the widespread adoption of FI techniques. Large-scale randomized trials are warranted to improve on existing protocols. Future research should emphasize improving FI's technological capabilities and clinical applicability to a broader range of tumor types and ablation procedures.

Assessment of efficacy and safety of advanced endoscopic irreversible electroporation catheter in the esophagus.

Nonthermal irreversible electroporation (NTIRE) is emerging as a promising tissue ablation technique. However, maintaining irreversible electroporation (IRE) electrodes against displacement during strong esophageal spasms remains an obstacle. The present study aimed to evaluate the efficacy and safety of newly designed balloon-type endoscopic IRE catheters. Six pigs were randomly allocated to each catheter group, and each pig was subjected to four ablations at alternating voltages of 1500 V and 2000 V. Esophagogastroscopy was performed during the IRE. The ability of balloon-type catheters to execute complete IRE with 40 pulses was assessed. The success rate was higher for the balloon-type catheter than that for the basket-type (12/12 [100%] vs. 2/12 [16.7%], p < 0.001). Following gross inspection and histologic analysis of the 1500-V vs. 2000-V balloon-type catheter revealed a larger mucosal damage area (105.3 mm2 vs. 140.8 mm2, p = 0.004) and greater damage depth (476 µm vs. 900 µm, p = 0.02). Histopathology of the ablated tissue revealed separated epithelium, inflamed lamina propria, congested muscularis mucosa, necrotized submucosa, and disorganized muscularis propria. Balloon-type catheters demonstrated efficacy, achieving full electrical pulse sequences under NTIRE conditions, and a safe histological profile below 2000 V (1274 V/cm). Optimal electrical conditions and electrode arrays pose ongoing challenges.

Cost-effectiveness Analysis of Radiofrequency Ablation in Patients With Barrett Esophagus and High-grade Dysplasia or Low-grade Dysplasia.

PURPOSE: Clinical guidelines recommend radiofrequency ablation (RFA) for eradication of Barrett esophagus in patients with low-grade dysplasia (LGD) and high-grade dysplasia (HGD), but evidence on whether RFA provides good value for money is still sparse. This study evaluates the cost-effectiveness of RFA in Italy. METHODS: A Markov model was used to estimate lifelong costs and consequences of disease progression with different treatments. RFA was compared with esophagectomy in the HGD group or endoscopic surveillance in the LGD group. Clinical and quality-of-life parameters were derived from a review of the literature and expert opinions, whereas Italian national tariffs were used as a proxy for costs. FINDINGS: RFA dominated esophagectomy in patients with HGD with a probability of 83%. For patients with LGD, RFA was more effective and more costly than active surveillance (incremental cost-effectiveness ratio, €6276 per quality-adjusted life-year). At a cost-effectiveness threshold of €15,272, the probability of RFA being the optimal strategy in this population was close to 100%. Model results were sensitive to the cost of the interventions and utility weights used in the different disease states. IMPLICATIONS: RFA is likely to be the optimal choice for patients with LGD and HGD in Italy. Italy is discussing the implementation of a national program for the health technology assessment of medical devices, requiring more studies to prove value for money of emerging technologies.