Liver microwave ablation:a systematic review of various FDA-approved systems

ObjectivesThe aim of the present study is to analyze preclinical and clinical data on the performance of the currently US Food and Drug Administration (FDA)-approved microwave ablation (MWA) systems.MethodsA review of the literature, published between January 1, 2005, and December 31, 2016, on seven FDA-approved MWA systems, was conducted. Ratio of ablation zone volume to applied energy R(AZ:E) and sphericity indices were calculated for ex vivo and in vivo experiments.ResultsThirty-four studies with ex vivo, in vivo, and clinical data were summarized. In total, 14 studies reporting data on ablation zone volume and applied energy were included for comparison R(AZ:E). A significant correlation between volume and energy was found for the ex vivo experiments (r=0.85,

Volumetric analyses of ablation dimensions in microwave ablation for colorectal liver metastases.

BACKGROUND In thermal ablation of malignant liver tumors, ablation dimensions remain poorly predictable. This study aimed to investigate factors influencing volumetric ablation dimensions in patients treated with stereotactic microwave ablation (SMWA) for colorectal liver metastases (CRLM). METHODS Ablation volumes from CRLM ≤3 cm treated with SMWA within a prospective European multicentre trial were segmented. Correlations between applied ablation energies and resulting effective ablation volumes (EAV) and ablation volume irregularities (AVI) were investigated. A novel measure for AVI, including minimum enclosing and maximum inscribed ellipsoid ablation volumes, and a surrogate parameter for the expansion of ablation energy (EAV per applied energy), was introduced. Potential influences of tumor and patient-specific factors on EAV per applied energy and AVI were analyzed using multivariable mixed-effects models. RESULTS A total of 116 ablations from 71 patients were included for analyses. Correlations of EAV or AVI and ablation energy were weak to moderate, with a maximum of 25% of the variability in EAV and 13% in AVI explained by the applied ablation energy. On multivariable analysis, ablation expansion (EAV per applied ablation energy) was influenced mainly by the tumor radius (B = -0.03, [CI -0.04, -0.007]). AVI was significantly larger with higher applied ablation energies (B = 0.002 [CI 0.0007, 0.002]]); liver steatosis, KRAS mutation, subcapsular location or proximity to major blood vessels had no influence. CONCLUSIONS This study confirmed that factors beyond the applied ablation energy might affect volumetric ablation dimensions, resulting in poor predictability. Further clinical trials including tissue sampling are needed to relate physical tissue properties to ablation expansion

Post-treatment three-dimensional voxel-based dosimetry after Yttrium-90 resin microsphere radioembolization in HCC

BACKGROUND: Post-therapy [(90)Y] PET/CT-based dosimetry is currently recommended to validate treatment planning as [(99m)Tc] MAA SPECT/CT is often a poor predictor of subsequent actual [(90)Y] absorbed dose. Treatment planning software became available allowing 3D voxel dosimetry offering tumour-absorbed dose distributions and dose-volume histograms (DVH). We aim to assess dose–response effects in post-therapy [(90)Y] PET/CT dosimetry in SIRT-treated HCC patients for predicting overall and progression-free survival (OS and PFS) and four-month follow-up tumour response (mRECIST). Tumour-absorbed dose and mean percentage of the tumour volume (V) receiving ≥ 100, 150, 200, or 250 Gy and mean minimum absorbed dose (D) delivered to 30%, 50%, 70%, and 90% of tumour volume were calculated from DVH’s. Depending on the mean tumour -absorbed dose, treated lesions were assigned to a < 120 Gy or ≥ 120 Gy group. RESULTS: Thirty patients received 36 SIRT treatments, totalling 43 lesions. Median tumour-absorbed dose was significantly different between the ≥ 120 Gy (n = 28, 207 Gy, IQR 154–311 Gy) and < 120 Gy group (n = 15, 62 Gy, IQR 49–97 Gy, p <0 .01). Disease control (DC) was found more frequently in the ≥ 120 Gy group (79%) compared to < 120 Gy (53%). Mean tumour-absorbed dose optimal cut-off predicting DC was 131 Gy. Tumour control probability was 54% (95% CI 52–54%) for a mean tumour-absorbed dose of 120 Gy and 90% (95% CI 87–92%) for 284 Gy. Only D30 was significantly different between DC and progressive disease (p = 0.04). For the ≥ 120 Gy group, median OS and PFS were longer (median OS 33 months, [range 8–33 months] and median PFS 23 months [range 4–33 months]) than the < 120 Gy group (median OS 17 months, [range 5–33 months] and median PFS 13 months [range 1–33 months]) (p < 0.01 and p = 0.03, respectively). CONCLUSIONS: Higher 3D voxel-based tumour-absorbed dose in patients with HCC is associated with four-month DC and longer OS and PFS. DVHs in [(90)Y] SIRT could play a role in evaluative dosimetry

A prospective multicentre trial on survival after Microwave Ablation VErsus Resection for Resectable Colorectal liver metastases (MAVERRIC).

AIM This multi-centre prospective cohort study aimed to investigate non-inferiority in patients' overall survival when treating potentially resectable colorectal cancer liver metastasis (CRLM) with stereotactic microwave ablation (SMWA) as opposed to hepatic resection (HR). METHODS Patients with no more than 5 CRLM no larger than 30 mm, deemed eligible for both SMWA and hepatic resection at the local multidisciplinary team meetings, were deliberately treated with SMWA (study group). The contemporary control group consisted of patients with no more than 5 CRLM, none larger than 30 mm, treated with HR, extracted from a prospectively maintained nationwide Swedish database. After propensity-score matching, 3-year overall survival (OS) was compared as the primary outcome using Kaplan-Meier and Cox regression analyses. RESULTS All patients in the study group (n = 98) were matched to 158 patients from the control group (mean standardised difference in baseline covariates = 0.077). OS rates at 3 years were 78% (Confidence interval [CI] 68-85%) after SMWA versus 76% (CI 69-82%) after HR (stratified Log-rank test p = 0.861). Estimated 5-year OS rates were 56% (CI 45-66%) versus 58% (CI 50-66%). The adjusted hazard ratio for treatment type was 1.020 (CI 0.689-1.510). Overall and major complications were lower after SMWA (percentage decrease 67% and 80%, p < 0.01). Hepatic retreatments were more frequent after SMWA (percentage increase 78%, p < 0.01). CONCLUSION SMWA is a valid curative-intent treatment alternative to surgical resection for small resectable CRLM. It represents an attractive option in terms of treatment-related morbidity with potentially wider options regarding hepatic retreatments over the future course of disease

Stereotactic and Robotic Minimally Invasive Thermal Ablation of Malignant Liver Tumors: A Systematic Review and Meta-Analysis.

Background Stereotactic navigation techniques aim to enhance treatment precision and safety in minimally invasive thermal ablation of liver tumors. We qualitatively reviewed and quantitatively summarized the available literature on procedural and clinical outcomes after stereotactic navigated ablation of malignant liver tumors. Methods A systematic literature search was performed on procedural and clinical outcomes when using stereotactic or robotic navigation for laparoscopic or percutaneous thermal ablation. The online databases Medline, Embase, and Cochrane Library were searched. Endpoints included targeting accuracy, procedural efficiency, and treatment efficacy outcomes. Meta-analysis including subgroup analyses was performed. Results Thirty-four studies (two randomized controlled trials, three prospective cohort studies, 29 case series) were qualitatively analyzed, and 22 studies were included for meta-analysis. Weighted average lateral targeting error was 3.7 mm (CI 3.2, 4.2), with all four comparative studies showing enhanced targeting accuracy compared to free-hand targeting. Weighted average overall complications, major complications, and mortality were 11.4% (6.7, 16.1), 3.4% (2.1, 5.1), and 0.8% (0.5, 1.3). Pooled estimates of primary technique efficacy were 94% (89, 97) if assessed at 1-6 weeks and 90% (87, 93) if assessed at 6-12 weeks post ablation, with remaining between-study heterogeneity. Primary technique efficacy was significantly enhanced in stereotactic vs. free-hand targeting, with odds ratio (OR) of 1.9 (1.2, 3.2) (n = 6 studies). Conclusions Advances in stereotactic navigation technologies allow highly precise and safe tumor targeting, leading to enhanced primary treatment efficacy. The use of varying definitions and terminology of safety and efficacy limits comparability among studies, highlighting the crucial need for further standardization of follow-up definitions

Outcomes after primary and repeat thermal ablation of hepatocellular carcinoma with or without liver transplantation

Objectives Thermal ablation (TA) is an established treatment for early HCC. There is a lack of data on the efficacy of repeated TA for recurrent HCC, resulting in uncertainty whether good oncologic outcomes can be obtained without performing orthotopic liver transplantation (OLTx). This study analyses outcomes after TA, with a special focus on repeat TA for recurrent HCC, either as a stand-alone therapy, or in relationship with OLTx. Methods Data from a prospectively registered database on interventions for HCC in a tertiary hepatobiliary centre was completed with follow-up until December 2020. Outcomes studied were rate of recurrence after primary TA and after its repeat interventions, the occurrence of untreatable recurrence, OS and DSS after primary and repeat TA, and complications after TA. In cohorts matched for confounders, OSS and DSS were compared after TA with and without the intention to perform OLTx. Results After TA, 100 patients (56 center dot 8%) developed recurrent HCC, of whom 76 (76 center dot 0%) underwent up to four repeat interventions. During follow-up, 76 center dot 7% of patients never developed a recurrence unamenable to repeat TA or OLTx. OS was comparable after primary TA and repeat TA. In matched cohorts, OS and DSS were comparable after TA with and without the intention to perform OLTx. Conclusions We found TA to be an effective and repeatable therapy for primary and recurrent HCC. Most recurrences can be treated with curative intent. There are patients who do well with TA alone without ever undergoing OLTx

The relationship between applied energy and ablation zone volume in patients with hepatocellular carcinoma and colorectal liver metastasis

To study the ratio of ablation zone volume to applied energy in computed tomography (CT)-guided radiofrequency ablation (RFA) and microwave ablation (MWA) in patients with hepatocellular carcinoma (HCC) in a cirrhotic liver and in patients with colorectal liver metastasis (CRLM). In total, 90 liver tumors, 45 HCCs in a cirrhotic liver and 45 CRLMs were treated with RFA or with one of two MWA devices (MWA_A and MWA_B), resulting in 15 procedures for each tumor type, per device. Device settings were recorded and the applied energy was calculated. Ablation volumes were segmented on the contrast-enhanced CT scans obtained 1 week after the procedure. The ratio of ablation zone volume in milliliters to applied energy in kilojoules was determined for each procedure and compared between HCC (R (HCC)) and CRLM (R (CRLM)), stratified according to ablation device. With RFA, R (HCC) and R (CRLM) were 0.22 mL/kJ (0.14-0.45 mL/kJ) and 0.15 mL/kJ (0.14-0.22 mL/kJ; p = 0.110), respectively. With MWA_A, R (HCC) was 0.81 (0.61-1.07 mL/kJ) and R (CRLM) was 0.43 (0.35-0.61 mL/kJ; p = 0.001). With MWA_B, R (HCC) was 0.67 (0.41-0.85 mL/kJ) and R (CRLM) was 0.43 (0.35-0.61 mL/kJ; p = 0.040). With RFA, there was no significant difference in energy deposition ratio between tumor types. With both MWA devices, the ratios were higher for HCCs. Tailoring microwave ablation device protocols to tumor type might prevent incomplete ablations. aEuro cent HCCs and CRLMs respond differently to microwave ablation aEuro cent For MWA, CRLMs required more energy to achieve a similar ablation volume aEuro cent Tailoring ablation protocols to tumor type might prevent incomplete ablations

Resectability and Ablatability Criteria for the Treatment of Liver Only Colorectal Metastases:Multidisciplinary Consensus Document from the COLLISION Trial Group

The guidelines for metastatic colorectal cancer crudely state that the best local treatment should be selected from a 'toolbox' of techniques according to patient- and treatment-related factors. We created an interdisciplinary, consensus-based algorithm with specific resectability and ablatability criteria for the treatment of colorectal liver metastases (CRLM). To pursue consensus, members of the multidisciplinary COLLISION and COLDFIRE trial expert panel employed the RAND appropriateness method (RAM). Statements regarding patient, disease, tumor and treatment characteristics were categorized as appropriate, equipoise or inappropriate. Patients with ECOG≤2, ASA≤3 and Charlson comorbidity index ≤8 should be considered fit for curative-intent local therapy. When easily resectable and/or ablatable (stage IVa), (neo)adjuvant systemic therapy is not indicated. When requiring major hepatectomy (stage IVb), neo-adjuvant systemic therapy is appropriate for early metachronous disease and to reduce procedural risk. To downstage patients (stage IVc), downsizing induction systemic therapy and/or future remnant augmentation is advised. Disease can only be deemed permanently unsuitable for local therapy if downstaging failed (stage IVd). Liver resection remains the gold standard. Thermal ablation is reserved for unresectable CRLM, deep-seated resectable CRLM and can be considered when patients are in poor health. Irreversible electroporation and stereotactic body radiotherapy can be considered for unresectable perihilar and perivascular CRLM 0-5cm. This consensus document provides per-patient and per-tumor resectability and ablatability criteria for the treatment of CRLM. These criteria are intended to aid tumor board discussions, improve consistency when designing prospective trials and advance intersociety communications. Areas where consensus is lacking warrant future comparative studies.</p

Comparison of Two 2.45 GHz Microwave Ablation Devices with Respect to Ablation Zone Volume in Relation to Applied Energy in Patients with Malignant Liver Tumours

PURPOSE: (i) to compare two 2.45 GHz MWA devices with respect to AZV in relation to the applied energy after MWA in patients with hepatocellular carcinoma (HCC) or colorectal liver metastasis (CRLM) and (ii) to identify potential confounders for this relationship. METHODS: In total, 102 tumours, 65 CRLM and 37 HCC were included in this retrospective analysis. Tumours were treated with Emprint (n = 71) or Neuwave (n = 31) MWA devices. Ablation treatment setting were recorded and applied energy was calculated. AZV and tumour volumes were segmented on the contrast-enhanced CT scans obtained 1 week after treatment. The AZV to applied energy R(AZV:E) ratios were calculated for each tumour treatment and compared between both MWA devices and tumour types. RESULTS: R(AZV:E)EMPRINT was 0.41 and R(AZV:E)NEUWAVE was 0.81, p &lt; 0.001. Moderate correlation between AZV and applied energy was found for Emprint (r = 0.57, R2 = 0.32, p &lt; 0.001) and strong correlation was found for Neuwave (r = 0.78, R2 = 0.61, p &lt; 0.001). R(AZV:E)CRLM was 0.45 and R(AZV:E)HCC was 0.52, p = 0.270. CONCLUSION: This study confirms the unpredictability of AZVs based on the applied output energy for HCC and CRLM. No significant differences in R(AZV:E) were observed between CRLM and HCC. Significantly lower R(AZV:E) was found for Emprint devices compared to Neuwave; however, reflected energy due to cable and antenna design remains unclear and might contribute to these differences

Robotic versus Freehand Needle Positioning in CT-guided Ablation of Liver Tumors:A Randomized Controlled Trial

Purpose: To compare the accuracy of freehand versus robotic antenna placement in CT-guided microwave ablation (MWA) of liver tumors. Materials and Methods: This study was conducted as a prospective single-center nonblinded randomized controlled trial (Netherlands Trial Registry, NTR6023). Eligible study participants had undergone clinically indicated CT-guided MWA of liver tumors and were able to receive a CT contrast agent. Randomization was performed per tumor after identification on contrast material-enhanced CT images. The primary outcome was the number of antenna repositionings, which was compared by using the Mann-Whitney U test. Secondary outcomes were lateral targeting error stratified by in-plane and out-of-plane targets and targeting time. Results: Between February 14 and November 12, 2017, 31 participants with a mean age of 63 years (range, 25-88 years) were included: 17 women (mean age, 57 years; range, 25-77 years) and 14 men (mean age, 70 years; range, 52-88 years). The freehand study arm consisted of 19 participants, while the robotic study arm consisted of 18 participants; six participants with multiple tumors were included in both arms. Forty-seven tumors were assessed; five tumors were excluded from the analysis because of technical limitations. In the robotic arm, no antenna repositioning was required. In the freehand arm, a median of one repositioning was required (range, zero to seven repositionings; P <.001). For out-of-plane targets, lateral targeting error was 10.1 mm +/- 4.0 and 5.9 mm +/- 2.9 (P = .007) for freehand and robotic procedures, respectively, and for in-plane targets, lateral targeting error was 6.2 mm +/- 2.7 and 7.7 mm +/- 5.9, respectively (P = .51). Mean targeting time was 19 minutes (range, 8-55 minutes) and 36 minutes (range, 3-70 minutes; P = .001) for freehand and robotic procedures, respectively. Conclusion: Robotic antenna guidance reduces the need for antenna repositioning in microwave ablation to accurately target liver tumors and increases accuracy for out-of-plane targets. However, targeting time was greater with robotic guidance than with freehand targeting. (C) RSNA, 201