Publications and Clinical Evidence Summary

Download the clinical evidence summary - featuring short summaries of each of the five most relevant and powerful publications that were done using CAS-One IR.

Title 

Conclusion

Ablation versus resection for resectable colorectal liver metastases - Health care related cost and survival analyses from a quasi-randomised study (2022)

Stereotactic percutaneous Electrochemotherapy has the potential to be used as a curative treatment method for HCC with diameters of more than 4 cm, even in close proximity to critical structures like major blood vessels and central bile ducts.

Stereotactic Percutaneous Electrochemotherapy as Primary Approach for Unresectable Large HCC at the Hepatic Hilum (2021)

Stereotactic percutaneous ECT has the potential to be used as a curative treatment method for HCC with diameters of more than 4 cm, even in close proximity to critical structures like major blood vessels and central bile ducts.

Volumetric Quantitative Ablation Margins for Assessment of Ablation Completeness in Thermal Ablation of Liver Tumors (2021)

The proposed volumetric approach for QAM computation including a novel algorithm to address subcapsular liver tumors enables precision and reproducibility in the assessment of ablation margins. The quantitative feedback on ablation completeness opens possibilities for intra-operative decision making and for refined analyses on predictability and consistency of local tumor control after thermal ablation of liver tumors.

Primary efficacy of percutaneous microwave ablation of malignant liver tumors: comparison of stereotactic and conventional manual guidance (2020)

In total, 221 patients with 423 treated liver lesions underwent microwave ablation (MWA). Manual guidance and stereotactic guidance were used for 136 and 287 lesions. Percutaneous microwave ablation under stereotactic guidance exhibited significantly greater primary efficacy than conventional manual guidance.

Value of MRI/CT Image Fusion for Targeting “invisible” Lesions in Stereotactic Microwave Ablation (SMWA) of Malignant Liver Lesions: A Retrospective Analysis (2020)

Technical success of MRI/CT image fusion was given in all 24 lesions in all 15 patients. Treatment success directly after ablation was 91.6% as full coverage was identified in 22 of 24 lesions. The first follow-up MRI examination showed complete ablation for 22 lesions (91.7%) in 13 patients.

Stereotactic Image-Guided Microwave Ablation for Malignant Liver Tumors—A Multivariable Accuracy and Efficacy Analysis (2020)

The median target positioning error per ablation probe was 2.9 ± 2.3 mm. Factors influencing ablation site recurrence were lesion size and target positioning error but not location of the lesion.

Percutaneous stereotactic image-guided microwave ablation for malignant liver lesions (2019)

The success rate was 97,5% with 1 incomplete ablation. 74% of the interventions were done with biopsy and microwave ablation. No major complications occured. There was a disease progression in 74% of the patients. The median time to progression was 7 months.

Stereotactic image-guided microwave ablation of hepatocellular carcinoma using a computer-assisted navigation system (2019)

All 88 patients were treated with the CAS-One procedure. The approach led to an efficacy rate of 96.3% and a local recurrence rate of 6.3% after 12 months. Intra-operative image fusion detected the need for immediate re-ablation in 15% of the ablations.

Initial experience with irreversible electroporation of liver tumours (2019)   

The method has been proven to be feasible and safe with promising oncological results. 81% of the treatments were performed with initial success. All patients with missed ablations were re-treated. Local recurrence rate at 3 months was 3% and 37% at one year.

1000 consecutive ablation sessions in the era of computer assisted image guidance – Lessons learned (2019)

With the aid of effective energy delivery in the form of microwaves and irreversible electroporation, and with the assistance of navigated targeting, ablative therapy of soft tissue tumours has come of age and within reach of all interventionists. Local ablative treatments may also in the near future be an integral part of boosted immunotherapy regime.

CT-guided navigated microwave ablation (MWA) of an unfavorable located breast cancer metastasis in liver segment I (2019) 

The efficient and successful ablation of the breast cancer metastasis in liver segment I shows that the CAS-One procedure enables and facilitates ablations in complex locations.

Stereotactic Radiofrequency Ablation of Hepatocellular Carcinoma: a Histopathological Study in Explanted Livers (2018) 

Multi‐probe SRFA with intraprocedural image fusion represents an efficient minimal invasive therapy for HCC, even with tumor sizes larger than 3cm, and without the need of a combination with additional treatments. The results seem to justify the additional efforts related to the stereotactic approach.

Treatment of lymph node metastases from gastric cancer with a combination of Irreversible Electroporation and Electrochemotherapy: a case report (2017)

Treatment was well tolerated with no major adverse effects.  At 6-week and 8-month follow-up there was no indication of tumor recurrence.

High frequency jet ventilation for motion management during ablation procedures, a narrative review (2017)

HFJV during ablation procedures supports the effect of less tissue movement, resulting in better surgical precision and outcome; such as shorter procedural
time, fewer shock waves (ESWL) and less recurrence of atrial fibrillation.

3D Navigation: do we need it?, CIRSE, (2017)

Stereotactic thermal ablation procedures are reliable and reproducible and challenge surgical resection as the first line treatment in primary and secondary liver tumors.

Navigated Percutaneous Lung Ablation under High-Frequency Jet Ventilation of a Metastasis from a Wilms’ Tumour: A Paediatric Case Report (2017)

The pediatric patient was successfully treated with percutaneous navigated microwave ablation under high- frequency jet ventilation. The case demonstrates the clinical applicability of new-generation targeting technologies.

Stereotactic CT-Guided Percutaneous Microwave Ablation of Liver Tumors With the Use of High-Frequency Jet Ventilation: An Accuracy and Procedural Safety Study (2017)

Percutaneous microwave ablation performed with CT-guide stereotactic navigation provides sufficient accuracy and requires almost no repositioning of the needle. Therefore, it is technically feasible for safe treatments.

Stereotactically-navigated percutaneous Irreversible Electroporation (IRE) compared to conventional IRE: a prospective trial (2016)

CT-navigated stereotactic IRE (SIRE) showed a significant reduction in procedure length and higher accuracy vs the conventional (CIRE) approach.  Radiation dose as measured by DLP was significantly lower in the SIRE group.

Stereotaktisch gestützte perkutane irreversible Elektroporation einer malignen Leberläsion unter Verwendung eines computergestützten Navigationssystems (2016) 

Procedure was successful. Set-up of navigation device and planning was 23 minutes, and needles (5 electrodes) were placed within 18 minutes, no repositioning was necessary.

Intra-interventional image fusion and needle placement verification for percutaneous CT-guided interventions (2015)   

Navigated percutaneous microwave ablation (MWA) has a sufficient level of lateral targeting accuracy (4.1 ± 2.6 mm), suggesting that navigated percutaneous application of MWA is accurate and efficacious. Target positioning error reported by intra-interventional image fusion and treatment verification module might be beneficial for the interventionalist for correcting the depth (longitudinal component) or before making a decision of repositioning the needle (lateral component).

New horizons in ablation therapy for hepatocellular carcinoma (2015)

Ablative therapies for HCC are becoming more efficient with advances in energy delivery and targeting, and are poised to become first line treatment for tumors < 30 mm in diameter with the benefits of sparing of liver parenchyma, shorter hospitalization time, fewer complications and shorter recovery times for patients.

A multiple microwave ablation strategy in patients with initially unresectable colorectal cancer liver metastases - A safety and feasibility study of a new concept (2014) 

The MWA group showed a 4-year overall survival of 41%, compared to 70% for a historic cohort of primarily resected patients and 4% for patients with palliative treatment, therefore suggesting a survival benefit compared to chemotherapy in the multiple ablation strategy.

Comparison of freehand-navigated and aiming device-navigated targeting of liver lesions (2013)

Using an aiming device may increase the lateral accuracy of navigated needle insertion. Time requirements were reduced using the aiming device and passive depth control. The lateral component was significantly lower when an aiming device was used (2.31.3–2.81.6 mm with an aiming device vs 4.22.0 mm without).

Cone-beam Computed Tomography-guided Stereotactic Liver Punctures: A Phantom Study (2013)

Stereotactic needle punctures might be planned and performed on volumetric CBCT images and controlled with multidetector CT with positioning accuracy higher or similar to those performed using CT scanners.

 

Ongoing

Title

Results/Conclusions

Microwave Ablation Versus Resection for Resectable Colorectal liver metastases (MAVERRIC) 2017

100 patients will be included and propensity scored matched with resected patients from the Swedish liver registry with the aim of proving non-inferiority in treating colorectal liver metastases with an ablative approach.